OUR NEW PROFILE IS: (NASDAQ: NLSP)

NLSP HAS OVER 100 PATENTS IN 140 DIFFERENT COUNTRIES

JASON MCCARTHY FROM MAXIM GROUP INITIATED A “BUY RATING”  ON NLSP WITH A $4.00 PRICE TARGET BACK IN JAN

NLSP HAS A LOW FLOAT WITH 14.8 MILLION SHARES COUPLED WITH A WELL FUNDED CASH POSITION OF $8.9MILLION (AS OF DEC. 31 2022)

NLSP HAS SEVERAL COMPANIES THAT ARE LOOKING TO PARTNER WITH THEM FOR THEIR PHASE 3 TRIALS AFTER LOOKING AT THE INITIAL DATA

READ THE INVESTOR PRESENTATION HERE

NLS Pharmaceutics today announced that the U.S. Food and Drug Administration (FDA) has reviewed the full protocol for the NLS-1031 study, part of the Phase 3 program for Mazindol ER, called AMAZE.

Read the full article here: https://t.co/pK3sqKztDz#nlspharmaceutics $NLSP pic.twitter.com/VDwgxHz6Bq

— NLS Pharmaceutics (@NLSPharma) July 3, 2023

__________

Hello Everyone,

We are extremely excited to bring you this next profile.

We just had you take a look at this one back in July where it ran all the way to 1.11 after closing at .83 the session before we released our profile on the company. Then we looked again back in August when it made another double digit move during the session.

Right now it is sitting back in the .90 range and has a smaller float of just over 14 Million.

It has made a 25% move over 2 sessions and has the potential to head back up over a buck.

Pull up NLSP right away.

NLSP is a clinical-stage pharmaceutical company focused on the discovery and development of innovative therapies for patients with rare and complex central nervous system, or CNS, disorders, who have unmet medical needs.

CNS disorders are a diverse group of conditions that include neurological, psychiatric, and substance abuse disorders. Their discovery platform currently focuses on single molecules that function through multiple mechanisms designed to target the complexity of the CNS disease state. They believe that this approach may potentially offer new treatment options for patients, including those who are refractory to currently available treatments. Their current focus is in the therapeutic areas of rare hypersomnia disorders (conditions characterized by excessive daytime sleepiness, or EDS, such as narcolepsy) and complex neurodevelopmental disorders. Their drug development pipeline features our lead product candidate, Quilience®, for the treatment of EDS and cataplexy associated with narcolepsy, and our follow-on drug candidate Nolazol®, for the treatment of ADHD.

The MAJOR Catalyst comes in the form of an update from the CEO released on back in August.

There were two catalysts in this release that caught my eye:

First, this caught my eye:  “At this time we have received several non-binding term sheets for a potential partnership agreement within the pharmaceutical industry. The Company is still in negotiations, has not executed a definitive agreement, and no party is under any obligation to enter into or continue negotiations regarding a definitive agreement related to any transaction.” 

This means that they have several companies that are looking to partner with them for their Phase 3 trials after looking at the initial data.  This could be a good sign for the company moving forward. 

Also, In the article it stated: “OnAugust 25, 2023, NLS submitted a fast-track designation application for Mazindol ER for the treatment of narcolepsy to the FDA. Fast track is a designation by the FDA of an investigational drug for expedited review to facilitate development of drugs that treat a serious or life-threatening condition and fill an unmet medical need. A drug may be granted Fast Track Designation if it is believed to have an impact on patient survival, day-to-day functioning, or if it is believed that the condition will progress in severity if left untreated. Standard reviews by the FDA for drug approval generally take about one year. A medicine that receives Fast Track Designation can be on the market within six months of the regulatory application.”   This could be huge for the company.  

“Fast Track” has the potential to be on the market as fast as 6 months.  

Read the full release here:

NLS PHARMACEUTICS CEO ISSUES LETTER TO SHAREHOLDERS

ZURICH, SWITZERLAND / ACCESSWIRE / August 28, 2023 / NLS Pharmaceutics Ltd. (Nasdaq:NLSP, NLSPW) (“NLS” or the “Company”), a Swiss clinical-stage biopharmaceutical company focused on the discovery and development of innovative therapies for patients with rare and complex central nervous system disorders, today announced that its Chief Executive Officer, Alex Zwyer, has issued the following letter to shareholders:

NLS Pharmaceutics CEO Issues Letter to Shareholders

To our Shareholders and Friends,

Though we may have been quiet recently, I wanted to assure you that the team here at NLS has been very busy behind the scenes ensuring that we realize our vision of awakening a brighter future for patients. Your investment and support to advance our pipeline in rare sleep disorders and other rare and debilitating Central Nervous System (CNS) disorders is our driving force as we put patients first to develop better therapies to safeguard and empower the brain throughout all stages of life. I am pleased to report on the progress that we have made towards achieving both our short and our long-term goals.

At the outset of 2023, we outlined a number of objectives including:

• Continuing to build an organization dedicated to rare and complex CNS disorders
• Solidifying the opportunity for lead product Mazindol ER’s success through a rigorous Phase 3 program
• Realizing Mazindol ER’s full potential across a variety of rare sleep disorders
• Progressing pipeline of innovative products to meet the unmet needs of patients and transforming the lives of patients with rare diseases

In addition to making significant progress on our objectives, we have advanced in our overall efforts by participating in global medical conferences, building investor relations and partaking in discussions regarding promising opportunities. As we are at the precipice of beginning our Phase 3 program for Mazindol ER, I wanted to take the opportunity to share the promises that we have kept and the advances that we have made, which we could not have achieved without your help.

Financing

In late 2022, we completed a $10 million private placement with BVF Partners L.P., a prestigious life sciences investor. The offering and shared vision reinforced our confidence in our development program, which has the potential to benefit more than three million people across the globe challenged with narcolepsy.

We are now in the process of assessing different options to initiate our Phase 3 program as well as our strategic plan, which includes: the potential need for capital, partnerships, venture debt opportunities and business development opportunities. We have significantly reduced our monthly expenditures to extend our cash runway while finalizing our efforts. At this time we have received several non-binding term sheets for a potential partnership agreement within the pharmaceutical industry. The Company is still in negotiations, has not executed a definitive agreement, and no party is under any obligation to enter into or continue negotiations regarding a definitive agreement related to any transaction.

Leadership

In May of this year, we announced the appointment of Keith Dewedoff to the position of Interim Chief Financial Officer (CFO). Mr. Dewedoff’s depth of expertise in finance within biotech, and his experience in executing growth capital initiatives, as well as corporate development and equity research, brought crucial talents into the Company at the right time. Mr. Dewedoff’s contributions have been significant.

Following Mr. Dewedoff’s appointment and after an exhaustive international search, in June we engaged Elena Thyen-Pighin, an experienced finance executive, to transition into the role of permanent CFO & Head of Finance / Human Resources. Ms. Thyen-Pighin’s position will be effective on September 1, 2023. Ms. Thyen-Pighin holds extensive experience in leadership and management functions as both head of finance and human resources across a number of industries, including organizations similar to NLS. Based in Switzerland, Ms. Thyen-Pighin speaks 5 languages and has a strong and successful track record, most notably in accounting for both private and publicly listed enterprises. Her responsibilities will include oversight of all financial operations as well as those related to human resources. We are thrilled to welcome her to the leadership team.

Mazindol ER

In July of 2023, NLS announced that the Phase 3 clinical trial (which we call the AMAZE Program) protocol to evaluate the safety and efficacy of Mazindol ER in patients with narcolepsy type 1 received approval from the independent Institutional Review Board (“IRB”). The AMAZE Program encompasses two almost-identical double-blind Phase 3 studies (N=50 each) investigating Mazindol ER versus placebo in adult patients with narcolepsy commencing this summer at multiple sites exclusively in the U.S. Based on the U.S. Food and Drug Administration’s (FDA) recommendations, both Phase 3 trials will measure the weekly cataplexy episodes as the primary endpoint over 8 weeks of treatment and excessive daytime sleepiness as a secondary objective using the Patient-Reported Outcomes Measurement Information System (PROMIS-SRI) and the Epworth Sleepiness Scale (ESS).

Along with IRB approval and the green light from the FDA, NLS has retained a contract research organization (CRO) and has enrolled a number of sites for the phase 3 studies. Once suitable capital has been secured, the phase 3 program will immediately commence as the sites are ready to begin enrolling patients.

On August 25, 2023, NLS submitted a fast-track designation application for Mazindol ER for the treatment of narcolepsy to the FDA. Fast track is a designation by the FDA of an investigational drug for expedited review to facilitate development of drugs that treat a serious or life-threatening condition and fill an unmet medical need. A drug may be granted Fast Track Designation if it is believed to have an impact on patient survival, day-to-day functioning, or if it is believed that the condition will progress in severity if left untreated. Standard reviews by the FDA for drug approval generally take about one year. A medicine that receives Fast Track Designation can be on the market within six months of the regulatory application.

Medical Congress Activities

At SLEEP 2023, the annual meeting of the American Academy of Sleep Medicine (AASM) and the Sleep Research Society (SRS), NLS presented our findings highlighting data from the recently completed Phase 2 multi-center U.S. clinical study evaluating Mazindol ER, a triple monoamine reuptake inhibitor and partial Orexin-2 Receptor agonist, in adult patients suffering from narcolepsy, which study met its primary endpoint with high statistical significance and demonstrated a favorable safety and tolerability profile. We believe that these results confirm the efficacy of Mazindol ER, as well as the safety and tolerability profile established in over 40 years of on-label and off-label use. Additional data from our Open Label Extension study (NLS-1022) further validated the positive results from our Phase 2 double-blind trial for Mazindol ER in narcolepsy and demonstrated the potential long-term efficacy, tolerability, and safety of the treatment.

In addition to presenting our findings, we spoke to hundreds of clinicians at our booth as well as presented to a packed room in our symposium entitled, Mazindol ER: Pioneering the Combination of SNDRI and OX2R in the Treatment of Narcolepsy, in which we, along with internationally renowned key opinion leaders (KOLs) in sleep medicine, Bruce Corser, M.D., Medical Director, Sleep Management Institute, Cincinnati, and Clete Kushida, MD, PhD, Chief and Medical Director, Division of Sleep Medicine, Stanford School of Medicine, presented on:

• Unmet needs in the treatment of Narcolepsy
• Phase 2 Clinical Data presentation for Mazindol ER (Studies NLS-1021 & NLS-1022)
• Phase 3 Program Summary for Mazindol ER (Studies NLS-1031, NLS-1032 & NLS-1033)
• NLS’ Pipeline

Progressing our Pipeline

The NLS current pipeline bridges the present to the future, providing a holistic approach and further strengthening the Company’s vision to awaken a brighter future for patients by overcoming rare and complex CNS diseases. We believe that our pipeline products are well positioned as we gain ground in establishing future market positions through patents for lauflumide (NLS-4) and other new chemical entities and assets. With extensive intellectual property (IP) coverage in the U.S., Japan and Europe, and promising pre-clinical data, we anticipate that our wake-promoting agent, lauflumide (NLS-4), could also offer a new option for the treatment of chronic fatigue, including fatigue associated with cancer treatment and long-COVID symptoms. We anticipate that clinical trials with lauflumide (NLS-4) will begin in 2024.

As we strive to develop better therapies to safeguard and empower the brain throughout all stages of life, these compounds, including Mazindol ER for the treatment of narcolepsy, along with NLS-4 focused on idiopathic hypersomnia and chronic fatigue, and NLS-11, addressing Kleine-Levin Syndrome and neurodegenerative diseases (e.g. Lewy body dementia), would offer much-needed treatment options to fill the gaps for patients with these disorders.

Current NLS pipeline products focused on Sleep disorders:

In May of this year, NLS presented new and compelling preclinical data on four of our pipeline compounds at the annual meeting of the American Society of Clinical Psychopharmacology (ASCP), in Miami, Florida. NLS’ Chief Scientific Officer, Eric Konofal, MD, PhD, presented data highlighting the Company’s focus on and investment in therapeutic areas of rare hypersomnia disorders and complex neurologic disorders:

• Effects of NLS-4 (Lauflumide) and modafinil in a rat model of chronic severe fatigue
• Effects of NLS-8 (Melafenoxate) on memory in a model of Alzheimer’s Disease, the scopolamine-induced amnesia in the novel object recognition test in mice
• Effects of NLS-11 (Benedin) on memory in the novel object recognition test in mice
• Effects of NLS-12 (Oxafuramine) on memory in the novel object recognition test in mice

We will continue to explore opportunities and execute on possibilities based on key factors such as unmet medical needs, biological rationales, safety profiles, feasibility of clinical development, potential for leveraging accelerated development pathways for regulatory approval, strong IP positions, favorable competitive landscapes, and attractive commercial potential.

The NLS discovery platform continues to focus on single molecules that function through multiple mechanisms designed to target the complexity of the CNS disease state. Our goal remains building a differentiated global pharmaceutical company that is patient-centered and dedicated to the development of transformative therapies addressing critical unmet needs. As we navigate the competitive landscape of our industry while focusing on the development of our product candidates, we are poised to maximize the therapeutic potential of our current pipeline while still pursuing new candidates that will continue to broaden our product portfolio.

Unwavering Support

At our Annual General Meeting (AGM) in July, NLS shareholders approved all of the Board of Directors’ proposals for the AGM that took place in Zürich, Switzerland on June 30, 2023. This included the election of Audrey Greenberg and Dr. Anthony Walsh to the Board of Directors, shareholder approval of financial statements, the compensation report and the balance sheet results of the Company for the fiscal year 2022. Shareholders also approved the total compensation budgets for NLS’ Board of Directors and Executive Management for the financial year 2024. PricewaterhouseCoopers AG was re-elected as NLS’ independent auditors for another term. Other key highlights from the meeting include 64% percent of the shares entitled to votes being represented and the Board of Directors receiving the highest voting approval in the Company’s history with 99.5% of votes cast in favor of the proposals.

A Bright Future

More than ever, we at NLS are committed and passionate to be a part of a company with genuine near and long-term prospects to change the lives of patients with rare CNS diseases. We work together in order to create a culture that inspires and motivates our team members to do what they do best. Our leadership team remains nimble with an honest approach to transparent communication, empowerment and individual ownership of responsibilities. Our team members thrive in finding innovative and efficient approaches to advance our corporate aspirations.

Together with our co-founder, Dr. Eric Konofal, I want to offer my sincerest gratitude to the clinical investigators and participating patients making it possible for Mazindol ER to be a potential class-leading treatment for narcolepsy in the future. I must also thank the many women and men across Europe and the U.S. that are part of the NLS team, from pre-clinical to regulatory affairs to supply chain and all in between, that endeavor every day to progress our objectives in treating these rare diseases. And finally, I would like to thank you, our shareholders and investors, for your continued support for and shared commitment to NLS.

With gratitude,

Alex ZwyerChief Executive Officer

Check out the new episode of https://t.co/t7Sg4BYOzU with our CEO Alexander Zwyer and CMO George Apostol. We discuss the story of Mazindol ER and how it helps patients with narcolepsy. https://t.co/MO6EnNbD2C#nlspharmaceutics #narcolepsy #SleepingAroundThePodcast $NLSP

— NLS Pharmaceutics (@NLSPharma) October 5, 2023

COMPANY HIGHLIGHTS

• Mazindol ER has successfully completed a Phase 2 trial, including OLE, for narcolepsy treatment: projected to be $4.5B annual market by 2027**
• Orphan Drug Designation (ODD) granted in the US and Europe
• AMAZE phase 3 program starting in July 2023, secured funding for current projects and existing operations through 2025. Development of Mazindol ER is in the spotlight for progression purposes, particularly for the treatment of EDS and cataplexy in adult patients who suffer from narcolepsy
• Named Patient Program for patients suffering from idiopathic hypersomnia launched in target markets across Europe
• Key Executive Leadership roles filled
• Pipeline progressed and expanded with long-dated IP protections in major markets
• Over 100 patents in over 140 countries including technology and application for a variety of diseases such as ADHD, Cancer Fatigue, Parkinson’s and more. Not to mention that several products are nearing the end of Phase 2 and approaching NDA filing
• POLARIS: Mazindol ER Phase 2 Program in Narcolepsy, consisted of two US clinicaltrials approved by the FDA, met its primary endpoint with high statistical significance and demonstrated a favorable safety and tolerability profile. These results were promising, i.e, Sustained EDS and cataplexy improvements at all time points. OLE conclusions: 6-month OLD, displayed good subject participation (87%) and retention (11.5%)
• Partnership with Université de Lausanne (UNIL) (preclinical projects), University of Berne (narcolepsy reserach), Swiss Narcoslpsy Network (narcolepsy reserach) ( (BVF Partners L.P (financial partnership) 
• Partnerships with Patient advocacy groups including Narcolepsy Network, The Narcolepsy Foundation, The Sleep Consortium, Hypersomnia Foundation, and Wake Up Narcolepsy

PIPELINE

NLS PHARMACEUTICS TO PROCEED WITH PHASE 3 CLINICAL PROGRAM (AMAZE) FOR MAZINDOL ER FOR THE TREATMENT OF NARCOLEPSY FOLLOWING FDA REVIEW AND IRB APPROVAL OF THE FULL STUDY PROTOCOL

ZÜRICH, SWITZERLAND / ACCESSWIRE / July 3, 2023 / NLS Pharmaceutics Ltd. (Nasdaq:NLSP)(Nasdaq:NLSPW) (“NLS” or the “Company”), a Swiss clinical-stage biopharmaceutical company focused on the discovery and development of innovative therapies for patients with rare and complex central nervous system disorders, today announced that the U.S. Food and Drug Administration (FDA) has reviewed the full protocol for the NLS-1031 study, part of the Phase 3 program for Mazindol ER, called AMAZE. In addition, the Company is pleased to announce that the Phase 3 clinical trial protocol to evaluate the safety and efficacy of Mazindol ER in patients with narcolepsy type 1 received approval from the independent Institutional Review Board (“IRB”). The AMAZE Program will encompass two almost-identical double-blind Phase 3 studies (N=50 each) investigating Mazindol ER versus placebo in adult patients with narcolepsy commencing this summer at multiple sites exclusively in the U.S.

Based on the FDA’s recommendations, both Phase 3 trials will measure the weekly cataplexy episodes as the primary endpoint over 8 weeks of treatment and excessive daytime sleepiness as a secondary objective using the Patient-Reported Outcomes Measurement Information System (PROMIS-SRI) and the Epworth Sleepiness Scale (ESS).

“In addition to IRB approval of the Phase 3 study protocol for AMAZE obtained last week, with this regulatory milestone acheived, we can recruit U.S. clinical sites quickly and efficiently, allowing us to move forward with providing Mazindol ER to patients with narcolepsy type 1,” commented George Apostal, MD, MS, Chief Medical Officer of NLS.

Patients who complete these studies will be offered participation in a 12-month open-label extension (OLE) study To be eligible for enrollment into the OLE study, patients must be at least 18 years of age and have been diagnosed with narcolepsy with cataplexy.

Alex Zwyer, Chief Executive Officer of NLS, said, “We are pleased with the FDA’s review of the Phase 3 protocol and now expect to move quickly to begin enrolling patients in the AMAZE program in centers across the U.S. in the coming days.”

For more information on the AMAZE Program, please visit https://amaze.nlspharma.com/.

NLS previously reported on the Phase 2 study results in narcolepsy in which Mazindol ER met all primary and secondary endpoints. Patients treated with Mazindol ER in the randomized Phase 2 trial showed continued improvement after rolling over into the OLE study and patients treated with placebo in the randomized Phase 2 trial and who subsequently received Mazindol ER in the OLE study showed similar efficacy with the Mazindol ER-treated patients in the randomized trial. Data from the Phase 2 studies were presented in early June at SLEEP 2023, the annual meeting of the American Academy of Sleep Medicine (AASM) and the Sleep Research Society (SRS). A recording of the Phase 2 data presentation can be found here: https://nlspharma.com/news/nls-satellite-symposium/.

An IRB operates under FDA regulations and is an FDA registered constituted group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications (to secure approval), or disapprove research. The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. To accomplish this purpose, IRBs use a group process to review research protocols and related materials (e.g., informed consent documents and investigator brochures) to ensure the protection of the rights and welfare of human subjects of research.

LEAD ASSET: MAZINDOL ER

Mazindol ER is a patented and proprietary formulation of the active compound mazindol, and are designed for once-daily dosing. Mazindol has a well-established safety record from its long history of clinical use in the United States and in Europe when the drug was approved in an immediate release formulation for the management of obesity. Mazindol was marketed for nearly 30 years under the trade name Sanorex® before being voluntarily withdrawn from the market, and the drug is no longer available nor marketed in these regions. During its time on the market, mazindol was also widely used off-label and prescribed under compassionate use for the treatment of narcolepsy for several decades. Use in these compassionate use programs has yielded evidence of positive efficacy in patents suffering from the symptoms of narcolepsy including patients that were refractory to approved treatments for the disorder. Additionally, these same programs, a retrospective analysis of investigator sponsored studies, and NLS’s own trial evaluating Mazindol ER in patients with ADHD provide evidence of the drug’s favorable safety profile at doses that yielded efficacy signals.

We believe that our lead product candidate,  Mazindol ER, offers a differentiated profile with clincally meaningful advantages over current treatment options for narcolepsy for the following reasons:

MECHANISM OF ACTION

If approved, Mazindol ER would be the only partial orexin 2 receptor agonist as well as the only triple monoamine reuptake inhibitor approved by the FDA for the treatment of narcolepsy. Narcolepsy is caused by a profound loss of orexin producing neurons. A partial orexin 2 receptor agonist may help to replace missing endogenous orexin peptide, addressing the underlying cause of the disease. In addition, the drug’s action as a triple monoamine reuptake inhibitor can further reduce disease specific symptoms, offering patients a treatment option that may address the two primary symptoms of narcolepsy – excessive daytime sleepiness (EDS) and cataplexy attacks – in a convenient once-daily oral tablet.

LOW POTENTIAL FOR ABUSE, MISUSE, AND DIVERSION.

Mazindol is currently classified by the DEA as a Schedule IV controlled substance . The DEA defines Schedule IV controlled substances as those “with a low potential for abuse and a low risk of dependence”. Unlike Xyrem® (sodium oxybate), the top-selling treatment for narcolepsy in the United States deemed to have a high potential for abuse/misuse (Schedule III), mazindol was never required by the FDA to have a risk evaluation and mitigation strategy (REMS) program in place to manage known or potential serious risks associated with its use.

QUILIENCE® HAS POTENTIAL TO BE ADMINISTERED AS A MONOTHERAPY.

Narcolepsy is a difficult disorder to manage and even with available treatments, the majority of narcolepsy patients often require multiple medications to treat their symptoms. According to the current treatment guidelines (initially published in 2007) of the American Academy of Sleep Medicine, or AASM, medications for narcolepsy, at best, provide only moderate improvement in narcolepsy symptoms, and their respective side effects may limit their use. The AASM specifically highlights that future investigations should be directed toward more effective and better tolerated therapies for treatment. The Voice of the Patient report from the FDA’s patient-focused drug development initiative, published in 2014, concluded that, based on the overall benefit-risk assessment of current medications, there is a continued need for additional effective and tolerable treatment options for patients with narcolepsy. A retrospective analysis (Nittur et.al, Sleep Med. 2013 Jan;14(1):30-6) showed that mazindol has a long-term, favorable benefit/risk ratio in 60% of drug-resistant patients with hypersomnia, including a clear benefit on the two primary symptoms of narcolepsy–EDS and cataplexy.

MAZINDOL ER IS BEING DEVELOPED AS A ONCE-DAILY ORAL TABLET ADMINISTERED IN THE MORNING UPON WAKENING.

Patients have identified a need for treatment options that are easier to take, dosed less frequently, do not disrupt nighttime sleeping, and provide full day coverage of symptoms. We believe that once-daily dosing with Mazindol ER may address this need and may help improve patient compliance and adherence with treatment. Mazindol ER utilizes our patented and proprietary extended-release (ER) formulation and is being designed to optimize its pharmacokinetic and pharmacodynamic properties with a rapid onset of action and prolonged controlled therapeutic effect, allowing for a daily oral dose that effectively provides consistent and long-acting symptom control to uniquely meet the needs of patients.

RELATIONSHIP BETWEEN NARCOLEPSY AND ADHD

Narcolepsy and psychiatric disorders have a significant but under-recognized relationship in which the two may coexist. However, narcolepsy is frequently misdiagnosed initially as a psychiatric condition, contributing to protracted times for accurate diagnosis and treatment. Narcolepsy is a disabling neurological condition that carries a high risk for the development of social and occupational dysfunction. Deterioration in function associated with narcolepsy may lead to the secondary development of psychiatric symptoms and inversely, the development of psychiatric symptoms can lead to a deterioration in function and quality of life. The overlap in treatments may further enhance the difficulty to distinguish between diagnoses.

ADHD is the most common neurobehavioral disorder characterized by symptoms of inattention, impulsivity and hyperactivity with an estimated prevalence rate of approximately 4-12% worldwide, as reported by the paper, “Understanding Attention Deficit/Hyperactivity Disorder From Childhood to Adulthood,” by Drs. Timothy E. Wilens and Thomas J. Spencer.

On the surface, ADHD may appear to be the opposite of narcolepsy; however, there may actually be significant clinical similarities between the two disorders. Cumulative data on sleep problems in children and adolescents with ADHD have shown that children with ADHD have had a higher rate of restless sleep, impaired sleep, and daytime sleepiness than children without ADHD. However, it is unclear whether EDS in ADHD is due to nocturnal sleep disturbances or primary vigilance disorders because shorter sleep onset latency is assessed in ADHD patients by the Multiple Sleep Latency Test, rather than in the control group irrespective of the presence/absence of sleep disturbances.

Alternatively, problems with sleep may represent an intrinsic component of ADHD. The presence of ADHD symptoms in children and adolescents with narcolepsy has been found to be about two-fold higher than in the general control population. Adults with narcolepsy have been found to have a much greater likelihood of having a diagnosis of ADHD in childhood compared to the general control population. Hyperactivity seen in ADHD may, in fact, be a compensatory response for individuals who are under-aroused or sleepy, and ADHD symptoms contribute to poor quality of life and increased frequency of depressive symptoms, similar to narcolepsy. To the best of our knowledge, almost all of the treatments used in ADHD have mechanistic overlap with treatments used in narcolepsy for EDS, and researchers suggest that the symptoms of EDS, fatigue, and sleep fragmentation may be the cause for ADHD symptoms, which is consistent with similar findings in other hypersomnia disorders.

http://polaris.nlspharma.com/

NLS PHARMACEUTICS RECEIVES GREEN LIGHT FROM THE U.S. FDA TO PROCEED WITH PHASE 3 CLINICAL PROGRAM (AMAZE) FOR QUILIENCE(R) (MAZINDOL ER) FOR THE TREATMENT OF NARCOLEPSY

ZURICH, SWITZERLAND / ACCESSWIRE / May 2, 2023 / NLS Pharmaceutics Ltd. (Nasdaq:NLSP, NLSPW) (“NLS” or the “Company”), a Swiss clinical-stage biopharmaceutical company focused on the discovery and development of innovative therapies for patients with rare and complex central nervous system disorders, today announced that the U.S. Food and Drug Administration (FDA) provided authorization to proceed with the Phase 3 program for Quilience® (Mazindol ER). The AMAZE Program will encompass two double-blind Phase 3 trials (N=50 each) investigating Mazindol ER versus placebo in adult patients with narcolepsy, commencing this summer at multiple sites in the U.S.

Both phase 3 trials, NLS-1031 and NLS-1032, will measure the weekly cataplexy episodes as the primary endpoint over 8 weeks of treatment. Patients who complete these studies will be offered participation in a 12-month open-label extension (OLE) study (Study NLS-1033). To be eligible for enrollment into the program, patients must be at least 18 years of age and have been diagnosed with narcolepsy with cataplexy.

Alex Zwyer, Chief Executive Officer of NLS, said, “We thank the FDA for the approval of this clinical program to evaluate Quilience® in chronically ill patients suffering from narcolepsy and we are thrilled to start recruiting for the U.S. clinical trial this summer. Today’s announcement builds on our commitment and focus to awaken a brighter future for patients with rare and complex central nervous system diseases.”

NLS previously reported on the Phase 2 study results in narcolepsy in which Quilience (Mazindol ER) met all primary and secondary endpoints. Patients treated with Mazindol ER in the randomized Phase 2 trial showed continued improvement after rolling over into the OLE study and patients treated with placebo in the randomized Phase 2 trial and who subsequently received Mazindol ER in the OLE study achieved comparable results to the Mazindol ER-treated patients in the Phase 2 trial. Data from the Phase 2 studies will be presented at SLEEP 2023, the annual meeting of the American Academy of Sleep Medicine (AASM) and the Sleep Research Society (SRS), which is being held from June 3 – 7, 2023, in Indianapolis.

“We are pleased that the FDA has approved our clinical development plan in narcolepsy patients. We believe that the FDA’s approval affirms the Company’s path to securing approval for Mazindol ER in order to treat a life-long chronic disorder with high unmet medical needs,” says George Apostol, Chief Medical Officer.

NEWS

PUBLISHED

JUL 3, 2023

NLS PHARMACEUTICS TO PROCEED WITH PHASE 3 CLINICAL PROGRAM (AMAZE) FOR MAZINDOL ER FOR THE TREATMENT OF NARCOLEPSY FOLLOWING FDA REVIEW AND IRB APPROVAL OF THE FULL STUDY PROTOCOL

PUBLISHED

JUN 30, 2023

NLS PHARMACEUTICS RELEASES THE RESULTS FROM ITS ANNUAL GENERAL MEETING

PUBLISHED

JUN 30, 2023

NLS PHARMACEUTICS COMPANY UPDATE AND WEBCAST TODAY POSTPONED

PUBLISHED

JUN 15, 2023

NLS PHARMACEUTICS TO PARTICIPATE IN THE HEALTHCARE VIRTUAL CONFERENCE PRESENTED BY MAXIM GROUP LLC AND HOSTED BY M-VEST

PUBLISHED

JUN 15, 2023

NLS PHARMACEUTICS ANNOUNCES COMPANY UPDATE WEBCAST

PUBLISHED

JUN 14, 2023

NLS PHARMACEUTICS ANNOUNCES POSITIVE SAFETY DATA FROM IN VITRO CYP450 AND TRANSPORTER MEDIATED DRUG-DRUG INTERACTION STUDIES OF MAZINDOL

PUBLISHED

MAY 8, 2023

NLS PHARMACEUTICS APPOINTS KEITH HARRISON DEWEDOFF AS INTERIM CHIEF FINANCIAL OFFICER

PUBLISHED

MAY 4, 2023

NLS PHARMACEUTICS PRESENTS LATEST CLINICAL AND PRECLINICAL DATA AT SLEEP 2023

PUBLISHED

MAY 2, 2023

NLS PHARMACEUTICS RECEIVES GREEN LIGHT FROM THE U.S. FDA TO PROCEED WITH PHASE 3 CLINICAL PROGRAM (AMAZE) FOR QUILIENCE(R) (MAZINDOL ER) FOR THE TREATMENT OF NARCOLEPSY

PUBLISHED

APR 25, 2023

NLS PHARMACEUTICS PRESENTS LATEST PRECLINICAL PIPELINE DATA AT AMERICAN SOCIETY OF CLINICAL PSYCHOPHARMACOLOGY

PUBLISHED

MAR 27, 2023

NLS PHARMACEUTICS ANNOUNCES OPEN LABEL EXTENSION STUDY SIX-MONTH DATA FOR QUILIENCE(R) (MAZINDOL ER) IN THE TREATMENT OF NARCOLEPSY TYPE 1 AND TYPE 2

PUBLISHED

MAR 1, 2023

NLS PHARMACEUTICS TO PRESENT AT THE 35TH ANNUAL ROTH CONFERENCE

PUBLISHED

JAN 30, 2023

NLS PHARMACEUTICS ANNOUNCES COMPLETION OF OPEN LABEL EXTENSION STUDY WITH QUILIENCE(R) (MAZINDOL ER) FOR THE TREATMENT OF NARCOLEPSY

PUBLISHED

JAN 25, 2023

NLS PHARMACEUTICS REGAINS COMPLIANCE WITH NASDAQ STOCKHOLDERS’ EQUITY REQUIREMENT

PUBLISHED

JAN 23, 2023

NLS PHARMACEUTICS ANNOUNCES NEW IN-VITRO DATA RECONFIRMING QUILIENCE’S(R) (MAZINDOL ER) UNIQUE DUAL MECHANISM OF ACTION INVOLVING SIGNIFICANT OREXIN-2 RECEPTOR ACTIVITY

PUBLISHED

JAN 12, 2023

NLS PHARMACEUTICS ANNOUNCES AN R&D UPDATE WEBCAST TO REVIEW THE COMPANY’S GROWING PORTFOLIO OF PRE-CLINICAL COMPOUNDS

MANAGEMENT TEAM

Alex Zwyer (CEO and Founder): 

Co-founder of the company, serial entrepreneur, served as COO at Viforpharma AG (global pharmaceutical company with a revenue of 1.99B in 2021) and a director since the company’s incorporation in 2015, been there since the beginning. Over 25 years of International business experience, notably when he served under Vifor International, global regulatory affairs, sales and marketing, furthermore was involved in the forefront of business development where he lead over 100 BD deals

Eric Konofal M.D. (CSO and Co-Founder):

Drug hunter and co-founder of NLS pharmaceutics, main expertise lies in his knowledge for clinical and scientific research. He’s a senior medical consultant for the Pediatric Sleep Disorders Center as well as the Principal Clinical Investigator at the Clinical Pharmacology and Pharmacogenetic Department at Robert-Debre University of Paris. Dr. Konofal has authored over 70 peer-reviewed publications in the area of sleep disorders and other CNS diseases, in fact it was Dr. Konofal that obtained the U.S. patent for mazindol (used in the treatment of ADHD), one of the key ingredients to the growth and development for the NLS pipeline (Mazindol ER Clinical Development Program.

George Apostol M.D. (CMO, Global Head R&D)

Worked in large pharma R&D organizations for more than 20 years. Broad drug development expertise across early,middle and late phases of development at the Global R&D organizations of Eli Lilly,Pfizer, Abbott, Novartis, Shire and Endo. Received distinguished R&D awards and achieved multiple regulatory approvals inUS, EU and Japan.

Keith Dewedoff (CFO)

More than 20 years of experience in the life science industry, ranging from biotech venture-backed start-ups to commercial publicly traded companies. Extensive expertise in strategic financial management, serving as CFO in organizations including Danforth Advisors, Code Bio, Ceptur Therapeutics and more than 10 other privately held and public companies at various life cycle stages.

SINCERELY,

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OUR NEW PROFILE IS:   (NASDAQ: OKYO)

OKYO IS SITTING WITH $4.0 MILLION CASH AS OF 31 MARCH 2023

OKYO ANTICIPATES HAVING TOPLINE DATA ON ITS DRUG, OK-101, IN QUARTER 4 OF 2023

Thank you @GoldmanSmallCap for the in-depth research report on $OKYO that has just been published. Find the link below for this latest coverage. #OKYOhttps://t.co/JOHI3xZZSD

— OKYO Pharma LTD (@OkyoPharma) May 9, 2023

_______________________________

Hello Everyone,

We have another profile for you to research for Thursday’s session.

So far this one has closed green 3 sessions in a row and was up 20% on Tuesday when the market got annihilated by 400+ points to the downside.

Pull up OKYO Immediately. 

You will notice by looking at the chart that this one has been on the move over the last few sessions.

OKYO is poised to emerge as a key player in the Dry Eye Disease (DED) treatment market.  Based on its preclinical studies, we believe OKYO could offer advantages over existing therapies, which are not viewed favorably by clinicians. These include fewer side effects, along with reduced inflammation and pain.

The ocular company industry and the DED sub- segment, are huge and growing at a rapid rate. The global DED market is expected to reach $6.54 billion in 2027, up from about $5.2 billion in 2019.

OKYO just commenced a Phase II clinical trial with the objective of measuring safety and efficacy of OK-101 in DED patients, along with secondary endpoints such as ocular pain. A serious issue among a number of DED sufferers, there is no FDA approved product for neuropathic pain.

Top-line data from the trial is scheduled for release by year-end 2023 and serves as a major milestone for OKYO.  We believe it is the catalyst for a re- valuation for the stock and for a mid-tier or top-tier firm to enter into a partnership with OKYO.

The ocular treatment segment has garnered major attention. A flurry of M&A has occurred at high valuations.

OKYO Pharma Limited is a life sciences company focused on the discovery and development of novel molecules to treat inflammatory dry eye diseases and ocular pain. The Company’s lead candidate to treat dry eye disease, OK-101, is currently in Phase II clinical trials in the US.

A range of ocular diseases, like glaucoma, uveitis and retinal diseases are most prevalent in the geriatric population, and rates of disease are increasing as the population ages. One of the most common ocular diseases is dry eye disease (DED). It affects almost 50 million people in the US, and the global market for DED was worth $4.5 billion in 2022. It is predicted to reach $6.3 billion by 2028, at a compound annual growth rate (CAGR) of 5.67% during the forecast period.

OKYO Pharma Ltd. (NASDAQ: OKYO) is a biopharma leading the way when it comes to developing novel treatments for DED and ocular pain. Founded in 2018, the company was able to bypass phase 1 safety trials and has begun screening patients for its phase 2 efficacy trials.

The trial includes 240 patients, and OKYO anticipates having topline data on its drug, OK-101, in Quarter 4 of 2023. OK-101 uses a novel chemerin receptor that both acts as an anti-inflammatory agent and reduces corneal neuropathic pain in the patient. As the treatment is administered topically as eye drops, there is almost no risk of systemic exposure or risk of the treatment getting into the bloodstream.

If the trial meets its pre-specified endpoints, this could contribute data toward registration trials, and speed up OK-101’s timeline for approval from the Food and Drug Administration (FDA).

The company is laser-focused on bringing its treatment to market, as it believes the treatment has significant potential in the sector. With recent acquisitions indicating a commitment from big biopharmaceuticals to the ophthalmology market, there may be many eyes watching the progress of OKYO’s phase 2 trials.

In 2018, OKYO successfully obtained (via assignment from Panetta Partners Limited, a related party) an exclusive license from On Target Therapeutics (OTTx) to patents owned or controlled by OTTx and a sub-license from OTTx to certain patents licensed by OTTx from Tufts Medical Center (TMC) to support its ophthalmic disease drug programs. These licenses gave OKYO the right to exploit the IP estate which is directed to compositions-of-matter and methodologies for treating ocular inflammation such as DED with lipid-linked chemerin analogues. OKYO also has a license from TMC to a separate IP estate for treating symptoms of ocular neuropathic pain, uveitis and associated pain. The scope of the TMC IP granted use through the sublicense with OTT is commensurate with the scope of use of the IP granted to OTT from TMC. This intellectual property, which includes 3 patents related to OK-101 including technology, dry eye, and neuropathic pain, forms the basis of OKYO’s OK-101 program.

Great progress today with the announcement that the placebo stage of our clinical trial has now begun. This extra stage of enrolment will give a more accurate readout at the end of the trial. https://t.co/0H3cQL1in7 $OKYO #OKYO

— OKYO Pharma LTD (@OkyoPharma) June 6, 2023

CHEMERIN RECEPTOR

• Chemerin, the endogenous agonist of chemerin receptor ChemR23, a specific member of the G protein coupled receptor (GPCR) class, activates immune cells at the inflammation site.
• Chemerin activates ChemR23 on circulating monocytes and macrophages, recruiting these cells to the inflammation site.
• Chemerin is also physiologically cleaved into smaller potent anti-inflammatory peptides that reprogram macrophages to repress inflammation inducing anti-inflammatory cytokines at the inflammatory site, thus restoring normal tissue structure and function.
• OK-101, OKYO’s lead drug candidate contains a stable chemerin-derived 10-mer peptide as the active anti-inflammatory component of the drug, along with a conjugated lipid component, producing both enhanced agonist potency along with wash resistance.

OK-101 DRUG CANDIDATE

• One of the major challenges with topical administration of any drug designed for treating OED is drug wash-out through natural processes of tearing and blinking, minimizing drug ‘residence’ time at the ocular site needed to provide a pharmacologic benefit.
• Membrane Anchored Peptide (MAP) technology enabled the development of a long acting and stable OK-101 drug candidate.
• OKYO’s lead drug candidate OK-101 consists of a 10-mer C-terminal chemerin peptide sequence, a linker component, and an anchoring lipid domain.
• Unique MAP technology enabled the development of a drug with enhanced potency and the expectation of increased drug residence time on the ocular surface.

DRY EYE DISEASE

• Approximately 5 million people suffer from ocular pain every year.
• Neuropathic corneal pain, a severe, chronic, and debilitating disease for which there are no approved commercial treatments currently available.
• Current treatments are limited to short term NSAIDs, steroids, and opioids in severe cases. Side effects and the risk of addiction to opioids is a serious concern.
• The Global ocular pain market is expected to reach $0.5 Billion by 2030.
• Topical administration of OKYO’s lead drug candidate OK-101 was effective in suppressing corneal pain in a ciliary nerve ligation mouse model of neuropathic corneal pain; exhibiting a potency similar to that of gabapentin, a commonly used oral drug for neuropathic pain that was conversely given by intraperitoneal injection.
• The pain-relieving potential of a dry eye drug would provide an important benefit to the considerable number of dry eye patients suffering from ocular pain in addition to the existing inflammatory effects of the condition.

ALLERGIC CONJUNCTIVITIS

• Allergic conjunctivitis, often called ‘pink eye’ is an inflammation of conjunctiva, caused by an allergic reaction to pollen, mold, smoke, dust etc.
• Up to 40% of the global population suffers from allergic conjunctivitis, which is mostly treated with antihistamines and corticosteroids (2018 annual revenue in US was > $1 Billion). Notably, a significant number of patients do not respond to antihistamines which typically leads to overuse of corticosteroids in these patients.
• In an animal model, OKYO’s lead drug candidate OK-101 was effective in suppressing ocular inflammation by downregulating key inflammatory CD4+ T cells.

• Uveitis is the third leading cause of blindness worldwide. The most common type of uveitis is an inflammation of the iris called iritis (anterior uveitis). Uveitis can damage vital eye tissue, leading to permanent vision loss.
• Uveitis is currently treated with corticosteroid eyedrops and injections that reduce inflammation, (2018 annual revenue in US was > $500M). However, the long-term use of corticosteroids causes risk of cataract and glaucoma, requiring close monitoring for their potential side effects.
• In an animal model, our lead drug candidate OK-101 was effective in suppressing ocular inflammation by downregulating key inflammatory biomarkers CD4+ T cells.
• Our focus is to suppress the inflammation and pain associated with the uveitis using our lead drug candidate OK-101.

OCULAR PAIN

• Worldwide, ~700 million patients suffer from dry eye disease. In US, ~30 million patients suffer from dry eye disease.
• Dry Eye affects over 35% of the population aged 50+, with women representing approximately two-thirds of those affected.
• Prevalence of dry eye is expected to increase substantially due to an aging population and increased use of contact lenses and digital screen time.
• Several side effects and modest efficacy of currently available drugs demand new therapies to treat dry eye disease.

OKYO PHARMA ACHIEVES 90% ENROLLMENT IN 240-PATIENT PHASE 2 CLINICAL TRIAL OF OK-101 TO TREAT DRY EYE DISEASE (“DED”)FULL ENROLLMENT ANTICIPATED BY FIRST WEEK OF SEPTEMBER

• OKYO on schedule to release top-line data before end of 2023
• Phase 2 trial is designed as potential registration trial with pre-specified primary efficacy endpoints covering both a sign and symptom of DED

LONDON and NEW YORK, Aug. 30, 2023 (GLOBE NEWSWIRE) — OKYO Pharma Limited (NASDAQ: OKYO), an ophthalmology-focused bio-pharmaceutical company which is developing OK-101 to treat DED to address the significant unmet need in this multi-billion-dollar market, is pleased to announce that it has enrolled and randomized 90% of the patients in its 240-patient Phase 2 multi-center, double-masked, placebo-controlled clinical trial of topical ocular OK-101 to treat DED.

“We are very pleased at the rapid pace of enrollment we are seeing in our ongoing Phase 2 trial of our flagship drug OK-101 to treat patients with DED. This trial began in May of this year, with the first patient being randomized in June into one of the three cohorts. Having enrolled 90% of the patients in this trial is an important milestone for OKYO Pharma,” said Gary S. Jacob, Ph.D., CEO of OKYO Pharma. “We presently have 216 patients enrolled in the trial and are anticipating completing full enrollment by the first week in September. Moreover, the pace at which we are enrolling patients has been encouraging in moving us toward our planned release of top-line data by end of 4Q 2023.”

“The Phase 2 clinical trial is a crucial step in the development of OK-101, evaluating its safety, efficacy, and tolerability in a larger patient population. We sincerely appreciate the clinicians and staff that are contributing to the conduct of this trial and are extremely grateful to the patients that have chosen to participate,” said Raj Patil, Ph.D., CSO of OKYO Pharma. “The Company remains laser focused on completing the trial, which is managed by our clinical development partner Ora Inc. a world leader in dry eye clinical research, and is committed to establishing the potential of this drug to treat the many millions of people currently suffering from DED.”

Dry eye disease is a common condition that occurs when one’s tears are unable to adequately lubricate the eyes. This condition affects approximately 49 million people in the United Statesalone and has been difficult to positively diagnose and treat due to the multifactorial nature of the condition. A number of contributing factors can lead to this condition, including age, sex, certain medical conditions, reduced tear production and tear film dysfunction. Tear film instability typically leads to inflammation and damage to the ocular surface and pain.

About the Phase 2 Trial Design

This phase 2, multi-center, randomized, double–blinded, placebo-controlled study is designed to enroll approximately 240 subjects with DED who are being randomly divided into 3 cohorts of 80 patients. Participants are being selected based on specific inclusion and exclusion criteria. The three cohorts include one cohort treated with placebo, a second cohort treated with 0.05% OK-101, and the third cohort receiving 0.1% OK-101. The drug and placebo, respectively, are being administered in both eyes twice daily for 12 weeks. The duration of a patient’s treatment is approximately 14 weeks, including a 2-week run-in period, to address the placebo effect, which is common for trials involving a pain component, followed by 12 weeks of treatment. The protocol for the study includes two prespecified primary endpoints and a number of secondary endpoints. Further details regarding the specifics of the trial are posted on the clinicaltrials.gov public website (clinicaltrials.gov Identifier: NCT05759208 or https://clinicaltrials.gov/ct2/results?term=Okyo&cond=Dry+Eye+Syndromes).

About OK-101

OK-101 is a lipid conjugated chemerin peptide agonist of the ChemR23 G-protein coupled receptor which is typically found on immune cells of the eye responsible for the inflammatory response. OK-101 was developed using a membrane-anchored-peptide (MAP) technology to produce a novel long-acting drug candidate for treating dry eye disease. OK-101 has been shown to produce anti-inflammatory and pain-reducing activities in mouse models of dry eye disease and corneal neuropathic pain, respectively, and is designed to combat washout through the inclusion of the lipid ‘anchor’ contained in the drug molecule to enhance the residence time of OK-101 within the ocular environment. OK-101 is currently in a Phase 2, multi-center, double-masked, placebo-controlled trial to treat dry eye disease.About Ora, Inc.

Ora is a world-leading full-service ophthalmic drug and device development firm with offices in the United States, United Kingdom, Australia and Asia. For over 40 years, the company has helped clients earn more than 50 product approvals. Ora’s pre-clinical and clinical models, unique methodologies, and global regulatory strategies have been refined and proven across thousands of global projects. The company brings together the world’s most extensive and experienced team of ophthalmic experts, R&D professionals, and management executives to maximize the value of new product initiatives.

NEWS

PUBLISHED

SEP 15, 2023

OKYO PHARMA ANNOUNCES CLOSING OF $4.0 MILLION REGISTERED DIRECT OFFERING OF ORDINARY SHARES

PUBLISHED

SEP 14, 2023

OKYO PHARMA ANNOUNCES PRICING OF $4.0 MILLION REGISTERED DIRECT OFFERING OF ORDINARY SHARES

PUBLISHED

SEP 14, 2023

OKYO PHARMA LIMITED ANNOUNCES WITHDRAWAL OF PUBLIC OFFERING

PUBLISHED

SEP 13, 2023

OKYO PHARMA ANNOUNCES PUBLIC OFFERING OF ORDINARY SHARES

PUBLISHED

SEP 8, 2023

OKYO PHARMA COMPLETES ENROLLMENT IN PHASE 2 CLINICAL TRIAL OF OK-101 TO TREAT DRY EYE DISEASE

PUBLISHED

AUG 30, 2023

OKYO PHARMA ACHIEVES 90% ENROLLMENT IN 240-PATIENT PHASE 2 CLINICAL TRIAL OF OK-101 TO TREAT DRY EYE DISEASE (“DED”)

PUBLISHED

AUG 29, 2023

OKYO PHARMA LIMITED REGAINS COMPLIANCE WITH NASDAQ LISTING MINIMUM MARKET VALUE RULE

PUBLISHED

AUG 15, 2023

OKYO PHARMA LIMITED REPORTS ANNUAL RESULTS FOR THE TWELVE MONTHS ENDED MARCH 31, 2023

PUBLISHED

JUL 31, 2023

OKYO PHARMA LIMITED ANNOUNCES WITHDRAWAL OF PUBLIC OFFERING

PUBLISHED

JUL 31, 2023

OKYO PHARMA ANNOUNCES PROPOSED PUBLIC OFFERING OF ORDINARY SHARES

PUBLISHED

AUG 15, 2023

OKYO PHARMA LIMITED REPORTS ANNUAL RESULTS FOR THE TWELVE MONTHS ENDED MARCH 31, 2023

PUBLISHED

JUL 31, 2023

OKYO PHARMA ANNOUNCES PROPOSED PUBLIC OFFERING OF ORDINARY SHARES

PUBLISHED

JUL 28, 2023

OKYO PHARMA LIMITED RECEIVES NASDAQ DEFICIENCY NOTICE

PUBLISHED

JUL 28, 2023

OKYO PHARMA PLANS TO INITIATE PHASE 2 TRIAL OF OK-101 IN NEUROPATHIC CORNEAL PAIN (“NCP”) FOLLOWING ANNOUNCEMENT OF CLINICAL TRIAL AGREEMENT WITH TUFTS MEDICAL CENTER         

PUBLISHED

JUL 28, 2023

OKYO PHARMA PLANS TO INITIATE PHASE 2 TRIAL OF OK-101 IN NEUROPATHIC CORNEAL PAIN (“NCP”) FOLLOWING ANNOUNCEMENT OF CLINICAL TRIAL AGREEMENT WITH TUFTS MEDICAL CENTER         

PUBLISHED

JUL 27, 2023

OKYO PHARMA ANNOUNCES APPOINTMENT OF WILLIAM A. CLEMENTI AS CHIEF OPERATING OFFICER

PUBLISHED

JUN 6, 2023

OKYO PHARMA ANNOUNCES RANDOMIZED SEGMENT NOW UNDERWAY IN PHASE 2 CLINICAL TRIAL OF TOPICAL OCULAR OK-101 FOR DRY EYE DISEASE

PUBLISHED

JUN 1, 2023

EYE CARE SECTOR SEES SEVERAL LARGE ACQUISITIONS – COULD THIS TICKER BE ON ROUTE FOR THE NEXT BIG ACQUISITION?

PUBLISHED

MAY 11, 2023

OKYO PHARMA NOW PARTICIPATING ON THE WEBULL CORPORATE COMMUNICATIONS SERVICE PLATFORM

PUBLISHED

MAY 11, 2023

OKYO PHARMA NOW PARTICIPATING ON THE WEBULL CORPORATE COMMUNICATIONS SERVICE PLATFORM

PUBLISHED

MAY 9, 2023

GOLDMAN SMALL CAP RESEARCH PUBLISHES NEW RESEARCH REPORT ON OKYO PHARMA LIMITED

PUBLISHED

MAY 4, 2023

OKYO PHARMA REACHES MILESTONE WITH FIRST PATIENT SCREENING FOR DRY EYE DISEASE TRIAL

PUBLISHED

MAY 3, 2023

OKYO PHARMA ANNOUNCES PRESENTATIONS AT THE AMERICAN SOCIETY OF CATARACT AND REFRACTIVE SURGERY (ASCRS 2023) IN SAN DIEGO, CA, MAY 5-8, 2023

MANAGEMENT TEAM

GARY JACOB, PHD

CHIEF EXECUTIVE OFFICER/DIRECTOR

Dr. Jacob has over 35 years of extensive experience in the pharmaceutical and biotechnology industries across multiple disciplines, including research and development, operations, business development, capital financing activities and senior management expertise. He has developed broad and influential contacts throughout the biopharmaceutical, financial, banking and investor communities. Dr. Jacob is the Co-Founder and former CEO and Chairman of Synergy Pharmaceuticals. During his time at Synergy, he served as Chairman, Chief Executive Officer and Executive Chairman, and is the co-inventor of Synergy’s FDA-approved drug Trulance® which is currently marketed in the U.S. by Bausch Health, Inc. to treat functional GI disorders. Dr. Jacob is also the former CEO and Managing Director of Immuron Inc., an Australian biotechnology company dual-listed on the Australian ASX exchange and on NASDAQ. Dr. Jacob currently is Chairman of the Board of Hepion Pharmaceuticals, Inc., a public NASDAQ listed company with a drug in clinical development to treat nonalcoholic steatohepatitis (NASH), and is also on the Board of Directors of Cardiff Oncology, Inc., a NASDAQ listed public oncology company. He served as Chief Executive Officer and Director of Callisto Pharmaceuticals, Inc. from May 2003 until January 2013.

Prior to his involvement with Callisto and Synergy, Dr. Jacob was at Monsanto/G.D. Searle, where he was Director of Glycobiology and a Monsanto Science Fellow, specializing in the field of Glycobiology and drug discovery. Dr. Jacob holds over 30 patents and is the co-inventor of two pharmaceutical drugs which are FDA approved. Dr. Jacob earned a B.S. cum laude in Chemistry from the University of Missouri, St. Louis and holds a Ph.D. in Biochemistry from the University of Wisconsin, Madison.

RAJ PATIL, PHD

CHIEF SCIENTIFIC OFFICER

Dr. Patil brings 30 years of ophthalmic experience and a powerful combination of academic scholarship and pharmaceutical R&D excellence.

Raj previously worked with Ora Inc, as Vice President of Research & Development, where he was responsible for driving all anterior and posterior segment research of Ora’s R&D Institute. Earlier in his career, he worked at iVeena Delivery Systems as Vice President of Advanced Ocular Delivery Systems. His tenure at iVeena included a two-year sabbatical in Singapore, where he served as an Associate Professor of Ophthalmology at DUKE/NUS Medical School and Principal Investigator at Singapore Eye Research Institute.

Raj also held a number of leadership roles at Alcon/Novartis Institute of Biomedical Research, including Associate Director of Research and Head of Molecular Pharmacology glaucoma and retina research. Prior to joining the business world, Dr. Patil served as an Associate Professor of Ophthalmology, Cell Biology & Genetics at University of Nebraska Medical Centre in Omaha and as an Assistant Professor of Ophthalmology, Molecular Biology & Pharmacology at Washington University in St. Louis.

Raj received his PhD in Biochemistry from National Chemical Laboratory/University of Pune, India and completed his postdoctoral training in Biochemistry and Molecular Biology at the University of Michigan, Ann Arbor, MI. He is the recipient of Olga Keith Wiess Special Scholar Award from Research to Prevent Blindness Foundation and NIH Director’s New Innovator Award. Dr. Patil has authored over 50 peer-reviewed research articles and serves as reviewer and editorial board member for numerous journals and is frequently invited to lecture at academic and industry events.

KEEREN SHAH

CHIEF FINANCIAL OFFICER

Keeren Shah serves as our Chief Financial Officer. Ms. Shah currently also serves as the Finance Director of Tiziana Life Sciences LTD, Accustem Sciences Limited and Rasna Therapeutics Inc., having previously served as the Group Financial Controller for all businesses from June 2016 to July 2020. Prior to joining the Company, Ms. Shah spent 10 years at Visa, Inc. as a Senior Leader in its finance team where she was responsible for key financial controller activities, financial planning and analysis, and core processes as well as leading and participating in key transformation programmes and Visa Inc.’s initial public offering. Before joining Visa, Ms. Shah also held a variety of finance positions at other leading companies including Arthur Andersen and BBC Worldwide. She holds a Bachelor of Arts with honours in Economics and is a member of the Chartered Institute of Management Accountants.

Willy Simon, Non-Executive Director

Willy Jules Simon is a banker and worked at Kredietbank N.V. and Citibank London before serving as an executive member of the Board of Generale Bank NL from 1997 to 1999 and as the chief executive of Fortis Investment Management from 1999 to 2002. He acted as chairman of Bank Oyens & van Eeghen from 2002 to 2004. Willy Simon has been the chairman of Bever Holdings, a company listed in Amsterdam, since 2006 and Chairman of Ducat Maritime since 2015. He is also a non-executive director of Tiziana Life Sciences plc.

John Brancaccio, Non-Executive Director

Mr. Brancaccio, a retired CPA, is a financial executive with extensive international and domestic experience in pharmaceutical and biotechnology for privately and publicly held companies. From 2000 to 2002, Mr. Brancaccio was the Chief Financial Officer/Chief Operating Officer of Eline Group, an entertainment and media company. From May 2002 until March 2004, Mr. Brancaccio was the Chief Financial Officer of Memory Pharmaceuticals Corp., a biotechnology company. From April 2004 until May 2017, Mr. Brancaccio was the Chief Financial Officer of Accelerated Technologies, Inc., an incubator for medical device companies. Mr. Brancaccio is currently a director of Cardiff Oncology, Inc., Hepion Pharmaceuticals, Inc., Rasna Therapeutics, Inc., and Tiziana Life Sciences plc.

Bernard Denoyer, Non-Executive Director

Bernard F. Denoyer has 49 years of financial management experience including his service as Senior Vice President, Finance and Secretary of development stage Synergy Pharmaceuticals, Inc, from July 2008 until FDA approval and his retirement in June 2017. Between 2004 and January 2013 Mr. Denoyer concurrently served as Principal Financial Officer of Synergy’s former parent company, Callisto Pharmaceuticals, Inc. From October 2000 to December 2003, Mr. Denoyer was an independent consultant. Prior to this, Mr. Denoyer served as Chief Financial Officer and Senior Vice President of META Group, Inc. Mr. Denoyer earned his CPA with Ernst & Young in 1975. He received a master’s Certificate of Accounting from the Kellogg Graduate School of Management in 1974, an MBA in Finance with honours from Columbia Business School in 1972 and a BA in Economics from Fairfield University in 1969. Mr. Denoyer is fluent in French and studied in Paris at l’Istitut d’Etude Politique et Economique in 1968. He is currently serving on the Board of Trustees for two not-for-profits, St. Edmunds Retreat, Inc. and Midwestern Connecticut Council on Alcoholism, Inc.

SCIENTIFIC ADVISORY BOARD

Napoleone Ferrara, MD, Board Member

Dr. Ferrara is a Professor at the University of California San Diego Medical Center and a member of The National Academy of Sciences and has received numerous prestigious awards, including the Lasker Award and the Breakthrough Prize in Life Sciences. His research on understanding the role of angiogenesis and vascular endothelial growth factor (VEGF) in cancer development, led to the discovery that VEGF is a key mediator of angiogenesis associated with intraocular neovascular syndromes. This pioneering research led to the clinical development of a humanized anti-VEGF Fab (Ranibizumab, Lucentis®), which has also been approved as a therapy for neovascular age-related macular degeneration (AMD), retinal vein occlusion and diabetic macular edema. Ranibizumab and other anti-VEGF agents have had a dramatic impact on the development of therapies for these blinding disorders. When Lucentis® (Ranibizumab) received FDA approval in late June 2006, the new macular degeneration drug was celebrated as a major medical breakthrough. Dr. Ferrara’s research also led to the development and approval of humanized anti-VEGF mAbs (Bevacizumab; Avastin®) for cancer treatment, with Avastin® being one of the bestselling cancer drugs over the last two decades. Lucentis® and Avastin® collectively achieved over $9 billion in sales last year.

Pedram Hamrah, MD, FRCS, FARVO, Board Member

Pedram Hamrah, MD is Co-Director of the Cornea Service and Director of the Center for Translational Ocular Immunology at New England Eye Center at Tufts Medical Center in Boston. Dr Hamrah’s research interests focus on corneal immunology and neuroscience, ocular imaging (immuno-imaging), ocular surface diseases and corneal neuropathic pain. He is currently on faculty at the departments of Ophthalmology and Bioengineering at Tufts University, where he is the director of clinical research and director of the Center for Translational Ocular Immunology. In addition, he is a faculty member at the immunology, neuroscience, and cell, molecular and developmental biology graduate programs at the Sackler School of Graduate Biomedical Sciences at Tufts. Throughout his career, he has focused on discovery, patient care and teaching. Dr. Hamrah currently serves on over a dozen editorial boards, is the associate editor for The Ocular Surface and TVST, section editor for Eye and assistant editor at Ocular Immunology and Inflammation.

Jay S. Pepose, MD, PhD, FARVO

Dr. Pepose, a specialist in refractive surgery and corneal and external diseases, is the founder and Medical Director of the Pepose Vision Institute and held the Bernard Becker Chair in Ophthalmology and Visual Sciences at Washington University School of Medicine in St. Louis. He is a consultant to numerous ophthalmic drug and device companies and serves as a Director and Chief Medical Advisor for Ocuphire Pharma. Dr. Pepose has been involved in over 40 clinical research trials, including registration trials for dry eye drugs, and has been the recipient of R-01 grant support from the National Eye Institute. He has served on the editorial boards of numerous prestigious journals, including the American Journal of Ophthalmology, Investigative Ophthalmology & Visual Science (IOVS), Cornea, and The Journal of Refractive Surgery and has over 200 peer reviewed publications. Dr. Pepose, an ARVO Gold Fellow, is a recipient of the Cogan Award from the Association for Research in Vision and Ophthalmology (ARVO) and the Life Achievement Honor Award from the American Academy of Ophthalmology. Dr. Pepose received an A.B. and M.A. in neurophysiology from Brandeis University and completed the M.D.-Ph.D. program at UCLA School of Medicine. He completed ophthalmology residency at the Wilmer Institute at the Johns Hopkins Medical Center and fellowship training at Georgetown University Medical Center

SINCERELY,

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OUR NEW PROFILE IS:   

(NYSE AMERICAN: MAIA)

THE COMPANY HAD CASH TOTALING APPROXIMATELY $9.1 MILLION AS OF JUNE 30, 2023

MAIA BIOTECHNOLOGY ANNOUNCES SHARE REPURCHASE PROGRAM JUST LAST WEEK!!

MAIA HAS CLOSED GREEN 4 SESSIONS IN A ROW AFTER BOUNCING OFF OF THE 52 WEEK LOW, TRIGGERING A MAJOR REVERSAL

READ THE INVESTOR PRESENTATION HERE

Hello Everyone,

We have a brand new NYSE profile for tomorrow’s session.

This is a company that we have never featured on this newsletter before.  In fact, I have never seen anyone profile this one in the past.

This could be a hidden gem with a major catalyst driving an intense reversal off of the 52 week low that it just recently hit.

It has been on a tear since then with above average interest starting to come into the company.

MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is THIO, a first-in-class cancer telomere targeting agent in clinical development for the treatment of Non-Small Cell Lung Cancer (NSCLC) patients with telomerase-positive cancer cells.

Last weeks news announcement regarding a share repurchase program certainly got the attention of investors and this one has been on fire as of late.

It has closed green 4 sessions in a row now and needs to be on your radar heading into tomorrow.

MAIA BIOTECHNOLOGY ANNOUNCES SHARE REPURCHASE PROGRAM

September 28, 2023 8:01am EDT

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc. (NYSE American: MAIA), a clinical stage company developing telomere-targeting immunotherapies for cancer, today announced that its Board of Directors has approved a share repurchase program with authorization to purchase up to $800,000 of its Class A common stock through September 2024.

“This share repurchase program demonstrates the confidence we have in our market opportunity and our strategy to invest for long-term growth, which we believe is not reflected in the current market valuation,” said Vlad Vitoc, MAIA’s Chief Executive Officer. “By establishing a repurchase plan, we add another tool to our arsenal that can assist with our future financing efforts, enable us to unlock more of the long-term opportunity we see ahead, and drive sustainable value for all stakeholders.”

With a share repurchase program, MAIA may repurchase shares from time to time through various methods, including in open market transactions, in privately negotiated transactions or otherwise, including through the use of trading plans intended to qualify under Rule 10b5-1 under the Securities Exchange Act of 1934, as amended, in compliance with applicable state and federal securities laws. The timing, as well as the number and value of shares repurchased under the program, will be determined by the Company at its discretion and will depend on a variety of factors, including our assessment of the intrinsic value of the Company’s common stock, the market price of the Company’s common stock, general market and economic conditions, available liquidity, compliance with the Company’s debt and other agreements, applicable legal requirements, the nature of other investment opportunities available to the Company, and other considerations. The Company is not obligated to purchase any shares under the repurchase program, and the program may be suspended, modified, or discontinued at any time without prior notice. The Company expects to fund the repurchases by using cash on hand and expected free cash flow to be generated in the future.

Significant Market Opportunity

• Cancer is the most dominant of the age-related disease categories and has life altering impacts in the lives of patients and their close ones
• The number oF people aged 80 years or older is expectedtotriplebetween 2020 and 2050 to reach 426 million

• Approximately40%ofpeoplealivetodayareprojectedtobediagnosed with a cancer type in their lifetime, and 20% will die of it
• NSCLC is the leading tumor type: Mortality 1.7M / Sales $32B (2022)
• CRCissecond:Mortality1M/Sales$20B(2022)

Clinical Programs

THIO-101: Ph 2 trial THIO + LIBTAYO® (cemiplimab) – enrolling (35 patients dosed to date)

• Go-to-market trial in second line NSCLC
• Objectives: select most efficacious dose and expand into pivotal trial
• Started in 2022 in Australia & Europe; to include US in 2023
• Regeneron clinical supply agreement for Libtayo®
• File for accelerated approval in 2025
• Part A (Safety Lead-in) Complete: No dose-limiting toxicities (DLTs), No Serious Adverse Events (SAE) or Serious Unexpected Suspected Adverse Reactions (SUSAR); Safety profile substantially better than current Standard of Care (SoC)
• Preliminary Survival: first 2 patients dosed in Part A continue to be alive, 12.2 and 11.5 months from treatment initiation; progression free after last dose, 10.2 and 8.5 months respectively, with no new treatment; in real-world clinical practice, observed survival in similar heavily pretreated patients is 3-4 months; weeks without therapy
• Disease Control Rate: 82%; subjects with 1+ post-baseline response assessment (n=11, 06/23/23); DCR for SoC in third line: 25-35%
• Part B (efficacy/dose selection) initiated THIO-102: Ph 2 trial THIO + CPIs

• Go-to-market trial in late line of therapy in multiple tumor. types: Colorectal Cancer (CRC), Hepatocellular Carcinoma (HCC, 90% of primary type of liver cancers), and Solid Tumors of any type (ST)
• 3 umbrellas in each: THIO + Libtayo (REGN); Keytruda (MRK); Tecentriq (Genentech/Roche)
• Objectives: select most efficacious combination by tumor type and expand into pivotal trials (9+ possible market entry indications)
• Start in 2023, to include US, Europe, Asia, etc.
• File for accelerated approvals in 2026 and beyond THIO-103: Ph 2/3 trial of THIO + CPIs

• First line NSCLC and SCLC
• Expand to Breast, Prostate, Pancreatic, Ovarian, Gastric Cancer, etc.

THIO is a Unique Direct Telomere Targeting Agent
• Potential to be used in combination with other anticancer and immune therapies
• Dual, novel mechanism of action: telomere targeting + immunogenic
• FDA awarded THIO 2 Orphan Drug

Designations: HCC and SCLC!
• Excellent efficacy: achieved complete and durable responses in HCC in vivo models (peer-reviewed published study)

Partnership with Regeneron

• Clinical supply agreement: Regeneron provides Libtayo® for THIO-101

• Equivalent to $32M non-dilutive participation (largest financing move to date)

• Potentially expand existing relationship and target new companies

Strong and Growing IP Portfolio

• Potential for receiving NCE marketing exclusivity; 5 patents issued, 12 patent applications pending

Next Generation Potential Telomere Targeting Therapeutics
• 84 new molecules engineered in last 12

months; Same mechanism of action as THIO • MAIA-2021-020, MAIA-2022-012 and

MAIA-2021-029 significantly moreCefficacious
• Follow THIO to commercial stage within 4-5 years

MAIA BIOTECHNOLOGY REPORTS SECOND QUARTER 2023 FINANCIAL RESULTS AND PROVIDES UPDATES FOR THIO-101 PHASE 2 TRIAL FOR NON-SMALL CELL LUNG CANCER

August 08, 2023 8:00am EDT

• Filed second provisional new composition of matter patent application for MAIA’s third entirely home-grown telomere-targeting molecule
• Reported 35 patients enrolled as of July 2023 in THIO-101 Phase 2 Trial
• First 2 patients dosed with THIO continue to be without documented disease progression for 12.2 and 11.5 months, and remarkably without any new anti-cancer treatment 10.2 and 8.5 months after concluding treatment with THIO, most patients only live for 3-4 months in similar heavily pretreated conditions
• Announced preliminary disease control rate (DCR) of 82%, with 9 of the first 11 patients with post-baseline scans meeting the disease control primary endpoint at first response assessment, typical DCRs are in the 25-35% range for chemotherapy
• Celebrated its 5^th anniversary since being founded on August 3^rd, 2018

CHICAGO–(BUSINESS WIRE)– MAIA Biotechnology, Inc., (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, today reported financial results for the second quarter ended June 30, 2023, and provided a corporate update.

“We recently reached an important milestone in the THIO-101 phase 2 trial, with our first patients dosed in the trial crossing the 1 year mark since starting therapy with THIO followed by an immune checkpoint inhibitor, without any additional cancer treatment. These positive preliminary results align well with our preclinical data and supported a faster pace of enrollment in the last quarter in Europe as we continue to activate more sites,” said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. “In addition to THIO, we have 3 proprietary home-grown telomere-targeting molecules patented which further expands our options to treat several cancer indications. For the second half of the year, we look forward to continue evolving in the Part B randomized efficacy/dose selection of THIO-101.”

Corporate Highlights

Reported second broad provisional patent application, nominating MAIA-2021-029 as the third new molecular candidate in MAIA’s Telomere-Targeting Molecule Program: MAIA is creating and evaluating multiple telomere-targeting compounds designed to modify the telomeric structure through the cancer cell intrinsic telomerase activity and cause the death of these cells. The studies, conducted in vitro in multiple cancer cell lines and in vivo in several pre-clinical cancer models, demonstrated the intended mechanism of action and high-level anti-cancer activity for these new molecules.

Announced updates in enrollment in THIO-101 Phase 2 clinical trial: As of July 2023, announced that 35 patients have been dosed in MAIA’s Phase 2 clinical trial, THIO-101, evaluating THIO in patients with advanced Non-Small Cell Lung Cancer (NSCLC). With the addition of sites in Hungary, Poland, and Bulgaria in March 2023, THIO-101 has rapidly increased the number of patients enrolled and dosed with THIO.

Reported positive updates on preliminary survival data for THIO-101: As of July 2023, the first 2 patients dosed with THIO continue to be alive for approximately 12.2 and 11.5 months respectively, from treatment initiation. They have remained free of disease progression for 10.2 and 8.5 months, respectively, without requiring any additional therapy.

Reported updates on disease control rates for THIO-101 Phase 2 trial for advanced Non-Small Cell Lung Cancer: As of July 2023, out of the first 11 patients with post-baseline scans, 82% (9 patients) met the disease control primary endpoint (defined as a complete response, partial response, or stable disease per RECIST 1.1) at first response assessment. In similar heavily treated NSCLC patients, typical disease control rates (DCR) are in the 25-35% range. All patients enrolled had previously failed 2 or more prior lines of treatment including an immune checkpoint inhibitor (CPI) and platinum-based chemotherapy for advanced NSCLC. No new safety analysis was conducted at the time.

Second Quarter 2023 Financial Results

Cash Position: The Company had cash totaling approximately $9.1 million as of June 30, 2023, compared to $8.2 million in cash as of June 30, 2022.

Research and Development (R&D) Expenses: R&D expenses were approximately $2.6 million for the quarter ended June 30, 2023, compared to approximately $2.1 million for quarter ended June 30, 2022. The increase was primarily related to an increase in scientific research expenses of approximately $0.44 million, an increase in payroll and bonus expenses of approximately $0.20 million related to the increased headcount of additional research and development employees, an increase in stock-based compensation costs of approximately $0.06 million and an increase of approximately $0.03 million in other expenses offset by a decrease in Clinical and Scientific research expenses of approximately $0.21 million due to less THIO-101 trial start-up fees, and a decrease in consulting of approximately $0.04 million.

General and Administrative (G&A) Expenses: G&A expenses were approximately $2.0 million for the quarter ended June 30, 2023, compared to approximately $1.3 million for the quarter ended June 30, 2022. The increase for the quarter was primarily due to an increase in other expenses of approximately $0.73 million related to the costs of operating as a public company, and an increase in payroll expense of approximately $0.13 million, offset by a decrease in stock-based compensation of approximately $0.02 million and professional fees of approximately $0.09 million.

Other Income (Expense): Other income was approximately $0.14 million for the quarter ended June 30, 2023, and other income for the quarter ended June 30, 2022 was approximately $0.14 million. The quarterly activity included a gain from the change in the fair value of the warrant liability of approximately $0.10 million offset by a reduction in the Australia research and development incentives of approximately $0.10 million and an increase in interest expense of approximately $0.002 million.

Net Income (Loss): Net loss was approximately $4.5 million for the quarter ended June 30, 2023, as compared to net loss of approximately $3.3 million for the quarter ended June 30, 2022.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is an investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. THIO is being developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About THIO-101, a Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s potential immune system activation effects in NSCLC patients by administering THIO in sequential combination an anti-PD1 therapy, allowing for immune activation and PD-1 sensitivity to take effect. The trial will test the hypothesis that low doses of THIO administered prior to a checkpoint inhibitor will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of THIO administered as an anticancer agent and a priming immune system agent (2) to assess the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

NEWS

Sep 28, 2023 8:01am EDT

MAIA BIOTECHNOLOGY ANNOUNCES SHARE REPURCHASE PROGRAM

Aug 08, 2023 8:00am EDT

MAIA BIOTECHNOLOGY REPORTS SECOND QUARTER 2023 FINANCIAL RESULTS AND PROVIDES UPDATES FOR THIO-101 PHASE 2 TRIAL FOR NON-SMALL CELL LUNG CANCER

Jul 11, 2023 8:00am EDT

MAIA BIOTECHNOLOGY REPORTS UPDATES ON DISEASE CONTROL RATES FOR THIO-101 PHASE 2 TRIAL FOR ADVANCED NON-SMALL CELL LUNG CANCER

Jul 10, 2023 8:00am EDT

MAIA BIOTECHNOLOGY REPORTS UPDATES ON PRELIMINARY SURVIVAL DATA FOR THIO-101 PHASE 2 TRIAL FOR ADVANCED NON-SMALL CELL LUNG CANCER

Jun 20, 2023 8:00am EDT

MAIA BIOTECHNOLOGY ANNOUNCES UPDATES IN ENROLLMENT IN PHASE II CLINICAL TRIAL: THIO-101 HAS ENROLLED 29 PATIENTS

Jun 07, 2023 8:00am EDT

MAIA BIOTECHNOLOGY FILES SECOND PATENT FOR NEW TELOMERE-TARGETING MOLECULES PROGRAM

May 08, 2023 8:00am EDT

MAIA BIOTECHNOLOGY REPORTS FIRST QUARTER 2023 FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE

Apr 27, 2023 4:10pm EDT

MAIA BIOTECHNOLOGY, INC. ANNOUNCES CLOSING OF PUBLIC OFFERING

Apr 24, 2023 9:06pm EDT

MAIA BIOTECHNOLOGY, INC. ANNOUNCES PRICING OF PUBLIC OFFERING

Apr 20, 2023 8:00am EDT

MAIA BIOTECHNOLOGY REPORTS PRELIMINARY SURVIVAL DATA IN PART A OF THIO-101 PHASE 2 TRIAL FOR NON-SMALL CELL LUNG CANCER

MANAGEMENT TEAM

VLAD VITOC, MD, MBA

CHIEF EXECUTIVE OFFICER AND CHAIRMAN

Dr. Vitoc is our Chairman of Board, Chief Executive Officer, and President. Dr. Vitoc has a broad array of experience across commercial strategic analysis and planning and medical affairs, in which he has 20 years of experience. During that time, Dr. Vitoc has managed and supported over 20 early, launch, and mature stage compounds, which have included targeted therapies and immune therapies across more than 25 tumor types, including colorectal cancer, hepatocellular carcinoma, lung cancer, breast cancer, prostate cancer, and renal cell carcinoma. Vlad received an M.D. from the University of Medicine and Pharmacy “Iuliu Hatieganu”, Cluj-Napoca, Romania, and his M.B.A. from the University of South Carolina.

JOSEPH F. MCGUIRE

CHIEF FINANCIAL OFFICER

Mr. McGuire is our Chief Financial Officer, and he brings over 30 years of experience to MAIA, having served as Chief Financial Officer for several privately held and publicly traded companies in the healt

SERGEI M. GRYAZNOV, PHD

CHIEF SCIENTIFIC OFFICER

Dr. Gryaznov is our Chief Scientific Officer. Dr. Gryaznov is an internationally recognized scientist and expert in the areas of modern drug discovery and development, oncology, telomerase, immune-regulatory therapeutics, nucleosides, nucleotides, DNA and RNA analogues, lipid and other conjugates, small molecules, and nucleic acid based therapeutic agents. Dr. Gryaznov is the co-inventor of a novel telomere-by-telomerase-targeting therapeutic approach to potential cancer treatment and responsible for leading the research team that characterized THIO’s telomere targeting activity, our lead compound in development. Dr. Gryaznov obtained an M.S., with Honors, in Organic Chemistry and a Ph.D. in Chemistry of Natural Products from M.V. Lomonosov Moscow State University. Dr. Gryaznov also completed a post-doctoral fellowship program in Chemistry at Northwestern University in Evanston, IL.

MIHAIL OBROCEA, MD

CHIEF MEDICAL OFFICER

Mihail is a board-certified internist and hematologist/oncologist with over 25 years’ experience in drug development in both academia and pharmaceutical/biotechnology industry. His broad clinical drug development expertise in both hematology and oncology covers equally early and late-stage development of cell therapy, cancer vaccines, monoclonal antibodies, and small molecules. Mihail completed a residency program in internal medicine at Yale University followed by a fellowship program in hematology/oncology at Dartmouth with academic appointment as Instructor of Medicine in the division of Hematology & Oncology at Mary Hitchcock Medical Center and Geisel Medical School at Dartmouth.

He started his career in pharmaceutical industry at Pfizer Oncology leading the CD40 agonist and IGF-1R antibodies projects, which entered in early clinical trials. Subsequently he led the Medical Affairs Oncology group at MedImmune, Gaithersburg MD and later as VP, Clinical Development Oncology at MannKind Corp., Valencia, CA successfully brought into clinic two cancer vaccine programs. As a Global Project Lead for AbbVie Biotherapeutics in Redwood City, CA, he was responsible for the early clinical oncology monoclonal antibody programs and as Head, Medical Sciences at Pharmacyclics, Sunnyvale CA he took part in the commercial launch of ibrutinib (IMBRUVICA™) program in mantle cell lymphoma and chronic lymphocytic leukemia. As VP of Clinical and Medical Affairs at SFJ Pharmaceutical Group, a venture pharma company supported the medical and business operations of the Pfizer Oncology partnership on the Phase 3, pivotal trial which led to the FDA approval of Besponsa® (inotuzumab ozogamicin) in the R/R adult B-cell ALL.

Later as US Clinical Lead at Nanobiotix Corp, a biotechnology company based in Paris, France which develops nanotechnologies for use in radiation oncology, established the US clinical programs and was involved in the strategic business development, investor, and partner interaction. As a Program Lead at Juno Therapeutics Inc and later Celgene he had the US clinical oversight of 2 clinical trials including the registration Ph 3 trial in second line aggressive large B-cell lymphomas of BREYANZI® (lisocabtagene maralucel) an autologous CD19 targeted CAR T program approved in both US and EU in R/R large B-cell lymphoma. More recently, as Project and Clinical Lead at Atara Bio, a T-cell therapy company based in Thousand Oaks, CA he supported the pre-clinical and clinical development of the Atara’s allogeneic CAR T platform for both lymphoma and solid tumor indications.

Mihail published in oncology peer-reviewed literature and is co-author of a couple of books related to cancer vaccines and immunology as well as he holds several patents in the field of biotechnology.

SINCERELY,

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OUR NEW PROFILE IS:   (NASDAQ: GWAV)

GWAV GENERATED $1.23MN IN POSITIVE CASH FLOWS FROM OPERATIONS DURING THE SIX MONTHS ENDING ON JUNE 30, 2023

GREENWAVE GENERATED OVER $18 MILLION IN REVENUE IN THE FIRST HALF OF THE YEAR

GWAV OPERATES 13 METAL RECYCLING FACILITIES IN VIRGINIA, NORTH CAROLINA, AND CLEVELAND, OH

YAHOO FINANCE HAS THE FLOAT AT JUST 8.59 MILLION SHARES RIGHT NOW

____

Hello Everyone,

We have another company for you to research tomorrow ahead of tomorrow’s session.  This is a company that we have never profiled on this newsletter before and has a tiny float working for it.

Pull up GWAV Immediately.

U.S. Steel Turns Down $7.3Bn Offer From Cleveland-Cliffs, Explores Alternatives – Potential Upside For Greenwave Technology Solutions, Inc. (Nasdaq: GWAV)?

Major developments in the steel industry are reshaping the landscape for key players. U.S. Steel, a significant player in the industry, has recently declined a substantial $7.3Bn acquisition offer from Cleveland-Cliffs and is now contemplating competitive proposals from Esmark Inc.

To add to the intrigue, there are rumors of ArcelorMittal SA considering entering the bid for this major steel manufacturer.

Amid this potential industry consolidation,  GWAV emerges as a proactive contender, gearing up for an aggressive expansion strategy to meet the escalating demands of leading U.S. steel mills.

 GWAV: Paving the Way for Growth in Metal Recycling

GWAV holds a prominent position as an operator of metal recycling facilities across Ohio, Virginia and North Carolina. Their core operations involve the collection, categorization, and processing of raw scrap metal, primarily to supply major steel mills and foundries. What sets Greenwave apart is its relentless pursuit of expansion and infrastructure enhancement, positioning itself as a key player during a potentially transformative phase in the steel industry.

Record-Breaking Growth: Positive Cash Flows and Expansion Plans

The first half of the year has seen Greenwave Technology Solutions, Inc. (Nasdaq: GWAV) achieved remarkable growth, marked by substantial in-vest-ments in infrastructure that have begun yielding impressive results. Notably, the company achieved a significant milestone by generating $1.23Mn in positive cash flows from operations during the six months ending on June 30, 2023—a record achievement for the company.

Investing Heavily in Infrastructure

GWAV’s strategy of heavy infrastructure investment over recent years is now showing substantial promise. A standout example is the installation of a new automotive shredder and downstream processing system at its Kelford, North Carolina facility. This innovative system focuses on recovering millimeter-minus metal pieces from the residue left in the shredder. This previously discarded residue, often referred to as “fluff,” holds substantial value, but effectively extracting it has proven challenging. The downstream processing system is designed to overcome this hurdle.

The downstream system officially commenced operations in July 2023, introducing a fresh revenue stream set to kickstart in Q3 2023. The company forecasts that this system will generate an average daily revenue of $38,000, boasting margins exceeding 80%. Furthermore, it is well on its way to achieving over $1Mn in monthly revenue by the year’s end.

Future Growth Anticipated

GWAV is accelerating its progress toward these goals with the impending launch of a second automotive shredder at its Carrollton facility. This addition will effectively double the metal recycler’s capacity to process ferrous metal. The decision to shred ferrous metal rather than selling it in its unshredded form positions the company to command higher prices, generating an estimated 33% increase in additional revenue compared to unshredded ferrous metal.

In April, GWAV expanded its footprint with the opening of a new facility in Cleveland. Even though it has not yet reached its full volume potential, this location is already generating approximately $100,000 per month in revenue. As operations further ramp up, particularly with the commencement of a shear baler this month, the Cleveland facility is poised to generate $250k or more per month in revenue by next year.

As U.S. Steel explores alternative pathways in a potentially consolidating steel industry,  GWAV stands out as a company actively positioning itself to seize new growth opp’s and strengthen its foothold in the ever-evolving world of metal recycling.

*****BREAKING NEWS RELEASED TUESDAY*****

GREENWAVE TECHNOLOGY SOLUTIONS ANNOUNCES ITS SHEAR BALER IS NOW FULLY OPERATIONAL AT ITS CLEVELAND FACILITY

Newly installed equipment to significantly increase facility’s metal recycling production capacity and ramp up revenue

CHESAPEAKE, Va., Sept. 26, 2023 /PRNewswire/ — Greenwave Technology Solutions, Inc.(“Greenwave” or the “Company”) (Nasdaq: GWAV), a leading operator of metal recycling facilities in Virginia, North Carolina, and Ohio, today announced that its recently installed shear baler is now fully operational at its Cleveland, Ohio facility. The state-of-the-art equipment is expected to significantly expand the facility’s metal recycling production capacity, enabling it to significantly increase its revenues. Shear balers are highly sophisticated processing equipment within the industry, designed for efficiently shearing car bodies and heavy metals.

“With access to an adjacent railroad to easily transport our products to nearby steel mills, we expect our Cleveland facility to be a significant contributor to Greenwave’s revenues in the coming quarters,” stated Greenwave Chief Executive Officer Danny Meeks. “We believe our Cleveland facility has the potential to be one of our highest volume and most profitable facilities. We’re grateful to our shareholders for their continued support and look forward to keeping investors updated on our progress.”

About Greenwave Greenwave Technology Solutions, Inc., through its wholly owned subsidiary Empire Services, Inc. (“Empire”), is a leading operator of 13 metal recycling facilities in Virginia, North Carolina, and Ohio. The Company’s recycling facilities collect, classify, and process raw scrap metal (ferrous and nonferrous) and implement several unique technologies to increase metal processing volumes and operating efficiencies, including a downstream recovery system and cloud-based ERP system.

Steel is one of the world’s most recycled products with the ability to be re-melted and re-cast numerous times. Recycling steel provides key environmental benefits over virgin metals, including reduced energy use, lower CO2 emissions, lower waste, and conserving natural resources. Greenwave’s customers include large corporations, industrial manufacturers, retail customers, and government organizations. The Company plans to aggressively expand its footprint of locations by acquiring independent, profitable scrap yards in the coming months. For more information, please visit www.GWAV.com.

GREENWAVE TECHNOLOGY SOLUTIONS’ COPPER EXTRACTION SYSTEM EXPECTED TO COMMENCE OPERATIONS IN SEPTEMBER 2023

New infrastructure and technology coming online to significantly increase processing capacity, resulting in increased annual revenues

CHESAPEAKE, Va., Aug. 29, 2023 /PRNewswire/ — Greenwave Technology Solutions, Inc. (“Greenwave” or the “Company”) (NASDAQ: GWAV), a leading operator of metal recycling facilities in Virginia, North Carolina, and Ohio, today announced that its Orbcon PTV balling mill is expected to commence operations in September 2023. The balling mill is expected to significantly increase the copper recovery yields in the downstream processing of Greenwave’s automotive shred residue, adding to revenues and gross margins.

In July 2023, Greenwave commenced operation of a downstream processing system at its Kelford, NC facility, enabling the Company to recover millimeter-minus pieces of metal from Greenwave’sautomotive shred residue or “fluff” as it is known in the industry. The Orbcon PTV balling mill is the final component of the downstream processing system – focused on extracting copper from the shred residue – and is expected to result in the downstream processing system generating more than $1 million per month in revenue by the end of 2023, with profit margins in excess of 80%.

“Greenwave has invested more than $15 million in capital expenditures over the past 18 months, which are expected to double the Company’s ferrous metal processing capacity, grow our annual revenues to over $50 million, and significantly expand our profit margins,” stated GreenwaveChairman and Chief Executive Officer Danny Meeks. “We are at an inflection point in Greenwave’sgrowth trajectory and the Company is now positioned to significantly expand its footprint of metal recycling facilities in the coming quarters. We’re grateful to Greenwave’s shareholders for their early and continued support – we look forward to reporting back on our progress.”

The Company has completed the installation of its second automotive shredder at its Carrolltonfacility to process cars, household appliances, and industrial products. The shredder is expected to commence operation as soon as the electrical infrastructure is completed this quarter, and will double the Company’s ferrous metal processing capacity. By selling its ferrous metal as shredded, rather than unshredded, Greenwave generates approximately 33% more revenue with profit margins in excess of 60%.

About Greenwave Greenwave Technology Solutions, Inc., through its wholly owned subsidiary Empire Services, Inc. (“Empire”), is a leading operator of 13 metal recycling facilities in Virginia, North Carolina, and Ohio. The Company’s recycling facilities collect, classify, and process raw scrap metal (ferrous and nonferrous) and implement several unique technologies to increase metal processing volumes and operating efficiencies, including a downstream recovery system and cloud-based ERP system.

Steel is one of the world’s most recycled products with the ability to be re-melted and re-cast numerous times. Recycling steel provides key environmental benefits over virgin metals, including reduced energy use, lower CO2 emissions, lower waste, and conserving natural resources. Greenwave’s customers include large corporations, industrial manufacturers, retail customers, and government organizations. The Company plans to aggressively expand its footprint of locations by acquiring independent, profitable scrap yards in the coming months.

GREENWAVE TECHNOLOGY SOLUTIONS REPORTS THIRD HIGHEST QUARTERLY REVENUES IN COMPANY HISTORY

Greenwave generated $1.23 million in positive cashflows from operations during the six months ended June 30, 2023, a new record for the Company

Company generated $18.46 million in revenues for the six months ended June 30, 2023, the second highest in the Company’s history

Subsequent to the close of the quarter, Greenwave closed a private placement for proceeds of $15 million, paying off all outstanding factoring advances and reducing its equipment financing debt by $2 million

CHESAPEAKE, Va., Aug. 15, 2023 /PRNewswire/ — Greenwave Technology Solutions, Inc.(“Greenwave” or the “Company”) (NASDAQ: GWAV), a leading operator of metal recycling facilities in Virginia, North Carolina and Cleveland, OH, is pleased to announce that it generated revenues of $9.46 and $18.45 million during the three and six months ended June 30, 2023, respectively, the third highest quarterly revenues in its history. Further, for the six months ended June 30, 2023, Greenwave generated positive cashflows from operating activities of $1.23 million – a new record for the greatest amount of cashflows generated by the Company during a six month period.

“Greenwave is continuing to position itself as one of the most robust metal recycling companies on the east coast, suppling steel and other recycled metals to some of the nation’s leading steel mills and foundries,” stated Danny Meeks, Chairman and CEO of Greenwave. “We believe there will continue to be aggressive consolidation in this industry, as demonstrated by yesterday’s buyout offer of U.S. Steel. We continue to execute on our strategic business objective – expanding our operations, increasing volumes, and growing our revenues – and believe Greenwave is one of the most unique and compelling companies in the metal recycling industry.”

Subsequent to the close of the quarter, Greenwave commenced operation of a downstream processing system at its Kelford, NC facility. The downstream processing system recovers millimeter-minus pieces of metal from Greenwave’s automotive shred residue or “fluff” as it is known in the industry. The Company has generated an average of $38,000 per business day in revenue, with margins exceeding 80%, from metal recovered by the downstream system since it commenced operations. As Greenwave continues to optimize the operation of its downstream processing system, and brings a copper extraction component online, revenues generated by its downstream processing system could exceed $1 million per month by the end of 2023. As a result of the downstream system commencing operations, the Company is currently generating positive cashflows from operating activities and expects to generate positive EBITDA for the year ending December 31, 2023.

Recent financial results and operational highlights:

• On August 1, 2023, closed a private placement for proceeds of $15 million, paying off all outstanding factoring advances and reducing its equipment financing debt by $2 million. This reduced Greenwave’s monthly cash repayment obligations by more than $800,000, significantly improving the Company’s cashflows.
• Greenwave no longer has any shares of preferred stock outstanding – in July 2023, the Company issued shares of common stock to fully satisfy and retire the Company’s Series Z Preferred Stock, previously owned by Greenwave’s Chairman Danny Meeks.
• Company’s second automotive shredder expected to come online this quarter – will double Greenwave’s ferrous metal processing capacity. By selling its ferrous metal as shredded rather than unshredded, the Company generates approximately 33% more revenue with profit margins in excess of 60%.
• Appointed Henry Sicignano III to the Company’s Board of Directors — Mr. Sicignano currently serves as the President of Charlie’s Holdings, Inc., a publicly traded consumer products company with sales in more than 90 countries. Prior to this role, he served as Chief Executive Officer, President, and Director of 22nd Century Group, Inc., a publicly listed plant biotechnology company. Additionally, Mr. Sicignano served as General Manager at NOCO Energy Corp, as well as Vice President at Kittinger Furniture Company, Inc. He currently serves on the board of directors of Kartoon Studios and served on the board of directors of Anandia Laboratories, Inc. until it was acquired in 2018. Mr. Sicignano holds a B.A. degree from Harvard College and an M.B.A. degree from Harvard University.
• Appointed Jason Adelman to the Company’s Board of Directors – Mr. Adelman brings extensive experience in advising and investing in emerging growth companies in the technology, media, medical device and biotech sectors. Mr. Adelman was the lead banker in Computer Motion’s merger with Intuitive Surgical and was a member of the board of directors of Pharmacyclics prior to its acquisition by Abbvie for over $20 billion. Currently, Mr. Adelmanserves as a member of the board of directors of Trio-Tech International, a global semiconductor services company, and Oblong, Inc., a leader in next generation collaboration technologies. Prior to founding Burnham Hill Capital Group, LLC in 2003, Mr. Adelman served as Managing Director of Investment Banking at H.C. Wainwright and Co., Inc. Mr. Adelmanholds a B.A degree in Economics from the University of Pennsylvania and a J.D. degree from Cornell Law School.

GREENWAVE TECHNOLOGY SOLUTIONS, INC. SHAREHOLDER UPDATE

• Company’s downstream processing system has commenced operations and is on track to generate in excess of $1,000,000 per month in revenue with 80%+ margins by the end of 2023.
• Greenwave expects to generate positive cashflows from operations and positive EBITDA for the year ending December 31, 2023.
• Second automotive shredder expected to commence operations in Q3 2023, doubling Greenwave’s ferrous metal processing capacity and significantly improving the Company’s top and bottom lines.
• Company strengthens balance sheet with $15 million financing.

CHESAPEAKE, Va., Aug. 3, 2023 /PRNewswire/ — Greenwave Technology Solutions, Inc.(“Greenwave” or the “Company”) (NASDAQ: GWAV), a leading operator of metal recycling facilities in Virginia, North Carolina and Cleveland, OH, is pleased to announce that it has commenced operation of a downstream processing system at its Kelford, NC facility. The downstream processing system recovers millimeter-minus pieces of metal from Greenwave’s automotive shred residue or “fluff” as it is known in the industry.

The Company has generated an average of $38,000 per business day in revenue, with margins exceeding 80%, from metal recovered by the downstream system since it commenced operations. As Greenwave continues to optimize the operation of its downstream processing system, and brings a copper extraction component online, revenues generated by its downstream processing system could exceed $1 million per month by the end of 2023. As a result of the downstream system commencing operations, the Company is currently generating positive cashflows from operating activities and expects to generate positive EBITDA for the year ending December 31, 2023.

“We are at an inflection point in Greenwave’s growth trajectory. With the downstream processing system now online and new infrastructure set to come online in the coming weeks, we believe Greenwave’s revenue growth will accelerate going into 2024, in addition to increasing profit margins,” stated Danny Meeks, Chief Executive Officer of Greenwave. “We are incredibly grateful for the trust and support of Greenwave’s shareholders. We are continuing to execute on our strategic growth initiatives and look forward to reporting back on our progress.”

Second Automotive Shredder

The Company is pleased to announce it has completed the installation of its second automotive shredder at its Carrollton facility to process cars, household appliances and industrial products. The shredder is expected to commence operation as soon as the electrical infrastructure is completed. Greenwave’s second automotive shredder is expected to come online this quarter and more than double the Company’s ferrous metal processing capacity. By selling its ferrous metal as shredded rather than unshredded, Greenwave generates approximately 33% more revenue with profit margins in excess of 60%.

The completion of Greenwave’s second automotive shredder concludes its multi-year capex cycle, under which the Company has invested more than $15 million in its infrastructure and equipment over the past 18 months. This capex cycle is expected to double its ferrous metal processing capacity from fiscal 2022 levels and result in the Company having the infrastructure to accretively scale to over 20 metal recycling facilities.

Cleveland Facility

Greenwave formally opened its Cleveland metal recycling facility in April 2023 and is currently generating approximately $100,000 in revenue per month. In the Company’s experience, it typically takes 9 to 12 months before a newly opened facility reaches its full volume and revenue potential – it takes time to optimize operations, inform the community that a new metal recycling facility is open, and for local businesses and individuals to get in the routine of bringing their metal to the new facility.

Greenwave has been installing a shear baler at this facility, expected to commence operations in August 2023, which will significantly increase the amount of metal the Cleveland facility can purchase, process, and sell. The Company’s Cleveland facility also has access to the adjoining railroad to easily transport the scrap metal it processes to steel mills and foundries. Hundreds of local businesses and individuals are accustomed to selling their metal scrap to facilities in the same vicinity on a regular basis. Given these factors, Greenwave expects the monthly revenue generated by its Cleveland facility will ramp to over $500,000 per month in 2024.

Strengthening the Company’s Balance Sheet

On August 1, 2023, Greenwave closed a private placement financing with certain institutional and accredited investors for the purchase and sale of senior secured convertible notes and warrants. Gross proceeds to the Company from the offering were $15 million, before deducting the placement agent’s fees and other offering expenses payable by the Company. The Company expects to use the proceeds to fully retire all factoring advances outstanding, reduce its equipment debt, and for general corporate purposes.

The notes mature in 24 months, are amortized in monthly cash payments commencing in the seventh month following the close and are convertible into shares of common stock at a fixed price of $1.50 per share.

The Special Equities Group, a division of Dawson James Securities Inc., acted as the sole placement agent for the financing.

For more information on this financing, please see the Company’s Current Report on Form 8-K filed with the U.S. Securities and Exchange Commission on August 3, 2023.

NEWS

PUBLISHED

1 DAY AGO

GREENWAVE TECHNOLOGY SOLUTIONS ANNOUNCES ITS SHEAR BALER IS NOW FULLY OPERATIONAL AT ITS CLEVELAND FACILITY

PUBLISHED

AUG 29, 2023

GREENWAVE TECHNOLOGY SOLUTIONS TO BE FEATURED ON BENZINGA ALL ACCESS AT 11:00AM EDT ON AUGUST 30, 2023

PUBLISHED

AUG 29, 2023

GREENWAVE TECHNOLOGY SOLUTIONS’ COPPER EXTRACTION SYSTEM EXPECTED TO COMMENCE OPERATIONS IN SEPTEMBER 2023

PUBLISHED

AUG 25, 2023

U.S. STEEL TURNS DOWN $7.3 BILLION OFFER FROM CLEVELAND-CLIFFS, EXPLORES ALTERNATIVES – POTENTIAL UPSIDE FOR GREENWAVE TECHNOLOGY SOLUTIONS?

PUBLISHED

AUG 24, 2023

GREENWAVE TECHNOLOGY SOLUTIONS REGAINS COMPLIANCE WITH NASDAQ LISTING STANDARDS

PUBLISHED

AUG 21, 2023

GREENWAVE TECHNOLOGY SOLUTIONS ANNOUNCES $3.2 MILLION REGISTERED DIRECT OFFERING PRICED ABOVE MARKET

PUBLISHED

AUG 15, 2023

GREENWAVE TECHNOLOGY SOLUTIONS REPORTS THIRD HIGHEST QUARTERLY REVENUES IN COMPANY HISTORY

PUBLISHED

AUG 3, 2023

GREENWAVE TECHNOLOGY SOLUTIONS, INC. SHAREHOLDER UPDATE

APR 5, 2023

GREENWAVE OFFICIALLY OPENS CLEVELAND FACILITY

PUBLISHED

FEB 15, 2023

GREENWAVE SECURES PROPERTY FOR METAL RECYCLING FACILITY IN CLEVELAND, OHIO

PUBLISHED

JAN 30, 2023

GREENWAVE EXPECTS OPTIMAL MARKET CONDITIONS IN 2023

PUBLISHED

JAN 26, 2023

GREENWAVE SECURES NEW CUSTOMERS TO INCREASE MARGINS

MANAGEMENT TEAM

DANNY MEEKS – CHAIRMAN & CEO

At 18 years old, with one truck, Danny Meeks started a hauling company which he quickly expanded by re-investing its profits. Within two years, Mr. Meeks had won contracts to provide hauling services for some the region’s largest projects, including the expansion of the Chesapeake-Bay Bridge Tunnel.

In 2000, Mr. Meeks started Meeks Disposal Corporation with 1 truck and 10 roll-off cans, which he quickly expanded to 100 trucks and 3,500 roll-off cans. After Hurricane Katrina hit, Meeks Disposal was awarded a $100 million federal subcontract for the clean-up of New Orleans, under which Mr. Meeks oversaw 1,500 trucks and 5,000 people. Mr. Meeks sold Meeks Disposal Corporation for $17 million in 2010.

In November 2012, Mr. Meeks was elected to Portsmouth City Council, where he served on the industrial, zoning, housing authority, economic development, and port & development boards. He was also a member of the budget committee, where he was instrumental in helping set the city’s $750 million annual budget that gave city employees raises without increasing taxes.

In 2002, Mr. Meeks started DWM Properties, LLC, through which he’s steadily built a portfolio of 106 properties valued at approximately $27 million.

In 2012, after Super Storm Sandy hit, Mr. Meeks started Select Recycling Waste Services, Inc., which was awarded a federal subcontract to provide cleanup services in New Jersey. In 2016, it started a trash division which expanded to 70 trucks and 4,700 front load and roll off containers. In 2020, Mr. Meeks sold the majority of SRWS’ assets for $27 million and in 2021, he sold the remaining assets for an additional $3 million.

In 2004, Mr. Meeks founded Empire Services, Inc. with 1 yard and over the past 17 years, he has expanded it to 11 yards and $25 million in annual revenue through both acquisitions and opening new locations from scratch.

Mr. Meeks is well-suited to serve on our Board due to his significant business and management experience and deep knowledge of growth and commercialization strategies. Mr. Meeks joined the Company’s Board to foster revenue-generating capabilities of the Company.

CHIEF FINANCIAL OFFICER

Mr. Isaac Dietrich – Isaac Dietrich founded Greenwave and previously held the following positions with the company: Chief Executive Officer (April 2013 – October 2017, December 2017 – September 2021); Chairman of the Board (April 2013 – October 2017, December 2018 – June 2021); Chief Financial Officer (April 2013 – May 2014, August 2017 – October 2017, March 2021 – November 2021); and a member of its Board of Directors (April 2013 – November 2021). Mr. Dietrich was a consultant to Greenwave from February 2022 to April 2023.

During this time, Mr. Dietrich was instrumental in closing public and private offerings of equity instruments for proceeds of tens of millions of dollars, developing a shareholder base of more than 27,000 investors, and closing an acquisition that resulted in the company generating $33.9 million in revenue in fiscal year 2022.

From September 2022 to present, Mr. Dietrich has served as the Director of Finance of Thumzup Media Corporation. Since February 2023, Mr. Dietrich has served on Alpha Energy, Inc.’s Board of Directors and as Chairman of its Audit Committee.

INDEPENDENT DIRECTORS

Mr. Henry Sicignano – Mr. Sicignano currently serves as the President of Charlie’s Holdings, Inc. (OTC: CHUC), a publicly traded consumer goods company with sales extending to more than 90 countries, a role which he has held since April 2021. Prior to this role, from March 2015 through July 2019, he served as Chief Executive Officer of 22nd Century Group, Inc. (Nasdaq: XXII), a publicly listed plant biotechnology company. Additionally, Mr. Sicignano has served as director of Kartoon Studios, Inc. (NYSE: TOON) since May 2023 and served as General Manager at NOCO Energy Corp, as well as Vice President at Kittinger Furniture Company, Inc. He also served on the board of directors of Anandia Laboratories, Inc., which was acquired in 2018. Mr. Sicignano holds a B.A. degree from Harvard College and an M.B.A. degree from Harvard University.  Mr. Sicignano serves chairman of the Audit Committee and as a member of the Compensation and Nomination and Corporate Governance Committees.

Mrs. Cheryl Lanthorn – Mrs. Lanthorn began her career as a Personal Administrator at Welton, Duke & Hawks before rising to an Accounting Administrator due to her work-ethic, extensive accounting knowledge, and attention to detail. For the next 14 years, Mrs. Lanthorn was a Software Trainer and Content Developer for Applied Systems, Inc., where she created webinars and instructional documentation to teach employees how to best utilize TAM, Vision, Epic, and other scalable software programs. From December 2015 to July 2022, Mrs. Lanthorn served as an Account Executive at Brown & Brown Insurance, where she managed one of the company’s largest books of business, managed employees and their books, trained new employees, and performed various other administrative duties. Since August 2022, Mrs. Lanthorn has been a Senior Account Manager at Marsh Mclennan Agency, LLC, where she manages large corporate accounts.  Mrs. Lanthorn serves on as Chairwoman of the Compensation and Nomination and Corporate Governance Committees and as a member of the Audit Committee.

Mr. John Wood – Since 1998, Mr. Wood has served as a licensed real estate agent in Virginia. Since 2010, He has served as the Principal Broker of John E. Wood Realty, Inc., based in Chesapeake, Virginia, where through his extensive relationships with business and community leaders, he has become one of the region’s most active real Residential, Commercial and Property Management Brokers. He is also the Virginia Principal Broker for two other companies, which rank in the top 10 in the nation.  In July 2018, he launched American Contracting Services, LLC, which has successfully completed hundreds of Commercial and Residential construction projects.  Mr. Wood serves on the Company’s Audit, Compensation, and Nomination and Corporate Governance Committees.

Mr. Jason Adelman – Mr. Adelman is the Founder and Managing Member of Burnham Hill Capital Group, LLC, a privately held financial advisory firm, and serves as Managing Member of Cipher Capital Partners LLC, a private investment fund. Mr. Adelman also serves as a member of the board of directors of Trio-Tech International (Nasdaq: TRT) and Oblong, Inc. (Nasdaq: OBLG). Prior to founding Burnham Hill Capital Group, LLC in 2003, Mr. Adelman served as Managing Director of Investment Banking at H.C. Wainwright and Co., Inc. Mr. Adelman graduated from the University of Pennsylvania with a B.A. in Economics, cum laude, and from Cornell Law School with a J.D. degree.  Mr. Adelman serves on the Company’s Compensation, and Nomination and Corporate Governance Committees.

SINCERELY,

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OUR NEW PROFILE IS:   (NASDAQ: MYSZ)

MYSZ REPORTED A STAGGERING 61% INCREASE IN CONSOLIDATED REVENUE, REACHING A TOTAL OF $1,290,000 FOR THE THREE MONTHS ENDED JUNE 30, 2023. THIS SURGE IN REVENUE IS CHIEFLY ATTRIBUTED TO THE GROWTH WITNESSED AT ORGAD AND THE STRATEGIC ACQUISITION OF NAIZ FIT

DOWNLOAD THE INVESTOR PRESENTATION HERE

________________________________

HELLO EVERYONE,

We have another profile that we want you to research immediately for Wednesday’s session.  This is a company that we have never profiled before that has several catalysts worth researching immediately.

This one has a small float and if you look at the chart you can see that it made a massive run off of it’s current levels back in August, proving it’s capability to more with the right factors driving it.

Let’s take a look at some of the reasons you should research this one now: 

• Ultra Low Float:According to Finviz.com, My Size, Inc. (Nasdaq: MYSZ) has less than 1.42 million shares available in its public float with insiders owning approximately 18.38% as of 9/7/23.⁽⁴⁾

• AI-Driven Technology:My Size, Inc. (Nasdaq: MYSZ) boasts a portfolio of cutting-edge, AI-driven measurement solutions that have the potential to revolutionize multiple industries. ⁽⁵⁾

• Disruptive Market Potential with Sustainability Focus:My Size, Inc. (Nasdaq: MYSZ) is an emerging AI-driven measurement solutions company set to disrupt the $38 billion apparel returns market. With a strong focus on sustainability, their solutions aim to reduce size-related returns, aligning with the growing emphasis on eco-conscious practices. ⁽¹⁾⁽²⁾

• Untapped Opportunity:
  The recent announcement of My Size, Inc. (Nasdaq: MYSZ) entering the $7 billion pet apparel market positions the company to tap into a rapidly growing segment with limited competition. ⁽⁶⁾

• Consolidated Revenue Soars: My Size, Inc. (Nasdaq: MYSZ) reported a staggering 61% increase in consolidated revenue, reaching a total of $1,290,000 for the three months ended June 30, 2023. This surge in revenue is chiefly attributed to the growth witnessed at Orgad and the strategic acquisition of Naiz Fit. ⁽²⁵⁾

• High-Profile Partnerships: My Size has already established partnerships with renowned fashion brands, demonstrating its ability to attract and collaborate with industry leaders. MySizeID and Naiz Fit’s AI-driven sizing solutions were adopted by the following brands: Diesel, Celio, Superdry, Marithe François Girbaud, Replay, Canali, Harper & Neyer, Rotholz, and Natura.. ⁽⁷⁾

ARTIFICIAL INTELLIGENCE (AI) MARKET POISED FOR EXPLOSIVE GROWTH, EXPECTED TO REACH OVER $2.5 TRILLION BY 2032 ⁽⁸⁾

The global artificial intelligence market has surged to unprecedented levels and shows no signs of slowing down. With a valuation of around $454 billionin 2022 and a projected compound annual growth rate (CAGR) of approximately 19%from 2023 to 2032, the market is experiencing a seismic shift driven by continuous research and innovation led by tech giants.⁽⁸⁾

Industries spanning automotive, healthcare, retail, finance, and manufacturing are embracing artificial intelligence as a central element of their operations. Tech giants are driving this transformation through substantial investments in research and development. For instance, Intel Corporation’s acquisition of Cnvrg.io, an Israeli company specializing in machine learning models, underscores the company’s commitment to advancing its artificial intelligence business.

Artificial intelligence has elevated technology to the forefront of organizations, revolutionizing various sectors. From self-driving vehicles reshaping transportation to life-saving medical equipment, AI has become an integral part of almost every device and software program. Its ability to analyze massive amounts of data, make complex decisions, and learn from patterns has made AI indispensable.⁽⁸⁾

As the global artificial intelligence market expands, it brings forth opportunities for innovation, efficiency, and growth. Industries are leveraging AI to optimize processes, enhance customer experiences, and achieve unparalleled levels of productivity.

Within this rapidly evolving landscape, one company to keep an eye on is My Size, Inc. (Nasdaq: MYSZ)

My Size, Inc. (Nasdaq: MYSZ) is an emerging player in the AI-driven measurement solutions market, offering innovative technologies to drive revenue growth and reduce costs for businesses. As industries increasingly adopt AI solutions, My Size’s offerings, such as MySizeID and Naiz Fit, hold great potential to disrupt traditional measurement processes in sectors like apparel, e-commerce, and logistics.

With a focus on delivering accurate and efficient measurement solutions, My Size, Inc. (Nasdaq: MYSZ) could be well-positioned to capitalize on the growth of the global artificial intelligence market.

See Fact Sheet

MY SIZE, INC. (NASDAQ: MYSZ)’S ULTRA-LOW FLOAT DEMANDS YOUR IMMEDIATE ATTENTION! ^(23)(4)

Low float stocks refer to the securities that remain after a company’s stock has been issued to its controlling investors — meaning there are relatively few shares for the public to buy.⁽²³⁾

Market participants typically consider a float of 10-to-20 million shares as a low float. Some larger corporations have very high floats in the billions.⁽²³⁾

Companies with a low float frequently have a large portion of their equity held by controlling investors such as directors and employees, which leaves only a tiny percentage of the stock available for public trading. ⁽²³⁾

That limited supply can cause dramatic price swings if demand changes quickly. ⁽²³⁾

Because low-float stocks have fewer shares available, market participants may have difficulty finding shares available. ⁽²³⁾

My Size, Inc. (Nasdaq: MYSZ) has less than 1.5 million shares available in its float (as of 9/7/23) according to FinViz.com.⁽⁴⁾ A low-float stock can make significant moves due to volatility from so few shares being available⁽²³⁾, so this could be one interesting situation to watch closely.

My Size, Inc. (Nasdaq: MYSZ) is also considered a nano-cap. In general, nano-cap companies have market capitalizations of less than $50 million.⁽²⁶⁾ Because nano-cap stocks are significantly smaller than mid cap or large cap companies, they have a higher potential to change valuation quickly.⁽²⁷⁾

As of 9/7/23, My Size, Inc. (Nasdaq: MYSZ) has a market cap of less than $2.2 million according to Finviz.com. ⁽⁴⁾

Which is why things could get very interesting and also why you need to start your research on My Size, Inc. (Nasdaq: MYSZ).

MY SIZE, INC. (NASDAQ: MYSZ): AN EMERGING AI-DRIVEN MEASUREMENT SOLUTIONS COMPANY POISED TO DISRUPT THE $38 BILLION APPAREL RETURNS MARKET.

The global artificial intelligence (AI) market is poised for exponential growth, and My Size, Inc. (Nasdaq: MYSZ) is making significant strides in this dynamic landscape. ⁽¹¹⁾

My Size, Inc. (Nasdaq: MYSZ) is an emerging AI-driven measurement solutions company set to disrupt the $38 billion apparel returns market. With a strong focus on sustainability, their solutions aim to reduce size-related returns, aligning with the growing emphasis on eco-conscious practices. ⁽¹⁾⁽²⁾

Founded in 2014 by Ronen Luzon, My Size was born out of a frustration with the challenges of online shopping, particularly the uncertainty around sizing and the hassle of returning ill-fitting items. Recognizing the impact of these issues on both consumers and retailers, Luzon set out to create a solution that would standardize sizing and enhance the online shopping experience. ⁽¹¹⁾

My Size developed a range of measurement apps, including MySizeID, BoxSize, SizeUP, First Look Smart Mirror, and Smart Catalogue, all based on the company’s patented algorithms and software development kits (SDK). These innovative measurement solutions have revolutionized the way consumers find the right fit across various size charts, driving buyer satisfaction and reducing costs for online retailers. ⁽¹¹⁾

Let’s take a closer look at My Size, Inc. (Nasdaq: MYSZ)’s AI-driven measurement solutions:

MYSIZEID

By leveraging My Size, Inc. (Nasdaq: MYSZ)’s MySize ID, retailers can match shoppers’ personal measurements with their brand’s size chart, resulting in significantly fewer returns and increased customer satisfaction. The platform comprises three essential elements: the widget, app, and My Dash. ⁽¹⁶⁾

The widget is seamlessly integrated into the retailer’s e-commerce platform, displaying size recommendations for individual shoppers on a per-item basis. These recommendations are based on data input into My Dash, the user-friendly size chart editor. Retailers can create a unique size profile for their customers using the MySize ID app or the online sizing wizard available on the My Size ID website. ⁽¹⁶⁾

My Dash plays a pivotal role by generating a comprehensive size chart for each apparel item and integrating it directly with the retailer’s product lifecycle management (PLM) and inventory database. Furthermore, MySize ID offers analytics with aggregated customer data, providing in-depth insights into consumer behavior. These insights enable retailers to further enhance personalization and tailor their offerings to meet customer preferences. ⁽¹⁶⁾

The MySize ID app or software development kit (SDK) empowers shoppers to create personalized size profiles by recording their body measurements with their smartphones. This convenience extends beyond online shopping and can be implemented in brick-and-mortar stores. Shoppers can easily scan barcodes, receive size recommendations, and make purchases directly through the app, bypassing fitting rooms and registers. ⁽¹⁶⁾

BOXSIZE

BOXSIZE: THE PERFECT MEASURING TOOL FOR LOGISTIC COMPANIES ⁽¹⁷⁾

Logistic companies often face the challenge of accurately measuring packages to ensure efficient shipping and storage. With Box Size, an innovative measuring tool, logistics professionals can streamline their operations and optimize package measurements. ⁽¹⁷⁾

To get started with Box Size, simply log into the Box Size app using your email address and organization code. Once logged in, you can easily scan the package’s barcode or add it manually. If the barcode is unavailable, you can leave the field blank and take all three measurements in one click.

Using the app, place your device on the surface next to the package, towards the bottom right corner, and tap “start.” Wait for the beep, then move the device to the top of the package. After another beep, move the device to the left side of the package. Finally, move the device to the upper left end of the package and wait for the last beep. Tap “save” to store all three measurements.

Box Size allows you to measure each dimension separately as well. To measure the package’s height, tap on the “height” option and place your device near the package’s surface. Tap “start” and wait for the beep, then gently lift your device and place it on top of the package. Remember to tap “save measurement” before continuing.

If needed, you can redo measurements by tapping “measure again.” Box Size also offers flexibility in measurement methods. You can change the height measurement method in the app’s settings, allowing you to move the device from a top corner to the same side’s bottom corner. ⁽¹⁷⁾

Box Size provides additional features to enhance measurement accuracy. You can customize measurement units and add the package’s weight, comments, pictures, and select the package type. Once you have finalized the measurements, tap “confirm and send file” to save the package’s information and transmit it to the Box Size dashboard or your server.

By using Box Size, logistic companies can ensure precise package measurements, leading to improved efficiency, reduced errors, and enhanced logistics operations. With its user-friendly interface and comprehensive functionality, Box Size is the perfect solution for accurate package measuring in the logistics industry. ⁽¹⁷⁾

SIZEUP

The SizeUp App is based on technology developed by MySize Inc. These revolutionary patent-pending algorithms that utilize Smartphone sensors to accurately measure anything from everyday objects to body measurements. ⁽¹⁸⁾

FIRST LOOK SMART MIRROR

Introducing First Look Smart Mirror, an interactive point-of-sale (POS) display that revolutionizes the in-store fashion shopping experience. With My Size ID integration, customers can preview items on a virtual avatar, ensuring accurate personalized sizing and fit. Real-time stock availability and upselling recommendations enhance the shopping journey, while NFC technology enables seamless checkout. This innovative solution reduces returns, boosts sales, and increases customer satisfaction. ⁽¹⁹⁾

BENEFITS OF FIRST LOOK SMART MIRROR ⁽¹⁹⁾

• Personalized Sizing: Customers input their measurements, and the mirror provides accurate size and fit checks.
• Stock Checking and Assistance: Real-time stock availability information and sales concierge service streamline the shopping process.
• Upselling and Complete Looks: Complementary items and accessories are showcased to enhance the styling experience.
• Effortless Checkout: NFC technology enables simple and contactless payments.

ADVANTAGES FOR RETAILERS ⁽¹⁹⁾

• Reduced Returns: Accurate sizing information and virtual try-on capabilities minimize returns and exchanges.
• Increased Sales: Upselling recommendations and complete looks drive additional purchases.
• Enhanced Customer Experience: Convenience, personalized assistance, and seamless checkout foster brand loyalty and satisfaction.

First Look Smart Mirror by My Size transforms the in-store fashion shopping experience, delivering personalized sizing, real-time stock availability, upselling, and effortless checkout. Retailers can enjoy reduced returns, increased sales, and improved customer satisfaction. Elevate your brick-and-mortar store with this innovative solution and stay ahead in the ever-evolving retail landscape. ⁽¹⁹⁾

As a testament to its growth and potential, My Size experienced significant investments and went public on NASDAQ in 2016. The company’s commitment to continuous innovation and expansion led to partnerships with renowned fashion brands, including Diesel, Natura, and Rotholz, among others, which adopted My Size’s AI-driven sizing solutions in 2022. ⁽¹¹⁾

Beyond its achievements, My Size is gaining recognition for its positive impact on sustainability. By reducing size-related returns, the company’s solutions align with the growing emphasis on environmentally conscious practices, making it an appealing choice for socially responsible stakeholders. ⁽¹¹⁾

Looking ahead, the global AI market is set to witness remarkable growth across industry verticals such as automotive, healthcare, retail, finance, and manufacturing. Tech giants like Google, Microsoft, IBM, Amazon, and Apple are investing heavily in AI research and development, further fueling technological advancements in these sectors. With a projected CAGR of 37.3% from 2023 to 2030, the global AI market is on track to reach a value of $1,591.03 billion by 2030. ⁽⁸⁾

Favorable government initiatives are also shaping the industry landscape, as countries recognize the transformative potential of AI. For example, the Government of India has increased spending for its Digital India initiative to boost AI, IoT, big data, cybersecurity, machine learning, and robotics. Similarly, the establishment of subcommittees on machine learning and AI within the federal government in the United States underscores the growing traction and support for AI-related advancements. ⁽⁸⁾

As the AI market continues to evolve, My Size, Inc. stands out as a company to watch. Its AI-driven measurement solutions have the potential to redefine the online shopping experience, enhance customer satisfaction, and drive revenue growth for businesses. With its innovative approach and commitment to technological advancement, My Size is poised to make a lasting impact in the ever-expanding AI landscape. ⁽¹¹⁾

UNTAPPED OPPORTUNITY: MY SIZE, INC. (NASDAQ: MYSZ) ENTERING THE $7 BILLION PET APPAREL MARKET

MySize, Inc. (Nasdaq: MYSZ) is set to make a groundbreaking move into the pet apparel market with the launch of MySizeID, an AI-driven sizing solution designed specifically for dogs and cats. This innovative solution aims to address the challenges faced by pet owners in finding the right fit and maximizing apparel comfort for their furry companions. ⁽⁶⁾

The pet apparel market is experiencing remarkable growth and is projected to reach an estimated value of $7 billion by 2028. Factors such as the increasing number of pet owners worldwide, the trend of pet humanization, the demand for sustainable pet clothing, and the entry of high-profile human fashion brands into the pet apparel sector are driving this expansion.

Notable fashion brands like Urban Outfitters, H&M, Moschino, Moncler, and Ralph Lauren have started offering pet apparel as an extension of their brand offerings. ⁽⁶⁾

MySize, Inc. (Nasdaq: MYSZ), known for its digital sizing solutions like MySizeID and Naiz Fit, is capitalizing on its position as a leading provider of accurate sizing recommendations for consumers. By extending its technology to the pet apparel market, MySize aims to revolutionize the way pet owners choose the right size for their furry friends. With a mobile phone-based sizing solution, MySizeID aims to simplify the process for pet parents and reduce the likelihood of size-related returns when purchasing pet apparel online. ⁽⁶⁾

In addition to providing convenience and accuracy in size recommendations, MySize, Inc. (Nasdaq: MYSZ)also aligns with the growing emphasis on sustainability in the fashion industry. By reducing size-related returns, the solution helps mitigate the environmental impact associated with the pet apparel market. ⁽⁶⁾

Ronen Luzon, CEO and Founder of MySize, Inc. (Nasdaq: MYSZ), expressed excitement about the company’s foray into the pet apparel market. He highlighted the need for an easy-to-use sizing solution given the wide variety of dog breeds, sizes, and proportions. Luzon believes that MySizeID will be the first pet apparel sizing solution on the market, making it a pioneering offering in the industry. ⁽⁶⁾

MySize’s expansion into the pet apparel market aligns with its overarching mission to drive revenue growth and reduce costs for its business clients. The company’s portfolio includes an omnichannel e-commerce platform, AI-driven measurement solutions, and the recently launched FirstLook Smart Mirror, which enhances the in-store shopping experience. ⁽⁶⁾

With its sophisticated measurement technology and commitment to innovation, MySize continues to make strides in various industries, including apparel, e-commerce, DIY, shipping, and parcel delivery. The company’s unique algorithms enable accurate and efficient measurements, contributing to improved customer experiences and operational efficiencies across diverse sectors. ⁽⁶⁾

MY SIZE, INC. (NASDAQ: MYSZ) REVOLUTIONIZES INVENTORY MANAGEMENT AND BOOSTS REVENUES FOR LA GARROCHA…⁽²⁶⁾

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In a remarkable success story, My Size, Inc. (Nasdaq: MYSZ) has announced the transformative impact of their AI-powered apparel sizing tool, Naiz Fit, on La Garrocha, a prestigious Spanish fashion brand renowned for its equestrian-themed creations. La Garrocha’s strategic implementation of Naiz Fit has not only streamlined inventory management but has also led to increased customer conversions and a substantial uptick in sales. ⁽²⁶⁾

A Powerful Partnership

La Garrocha has long been celebrated for its unique fashion offerings, but like many businesses in the modern era, they faced the challenge of optimizing inventory and enhancing the online shopping experience for their customers. This is where My Size, Inc. (Nasdaq: MYSZ) and their innovative Naiz Fit solution entered the picture.

Over the past two years, La Garrocha has witnessed a significant transformation in its operations. Customers who utilized Naiz Fit during their shopping experience contributed nearly €600,000 (approximately $654,000.00) in purchases. This is a testament to the substantial value that My Size’s technology brought to La Garrocha’s bottom line.

Impressive Conversion Rates

The impact of Naiz Fit on La Garrocha’s conversion rates is nothing short of remarkable. Since the beginning of 2023, an impressive 14.28% of first-time visitors to La Garrocha’s e-commerce platform who used Naiz Fit proceeded to make purchases. What’s even more astounding is that customers who engaged with Naiz Fit exhibited a staggering 127% higher likelihood of completing a purchase compared to those who did not use the sizing tool.

These numbers are particularly significant for La Garrocha, as a substantial portion of their sales occur online. The utilization of Naiz Fit has not only improved their conversion rates but also streamlined the shopping process for their customers, ultimately enhancing the brand’s competitiveness in the digital market.

Streamlined Inventory Management

Miguel Ángel García Rodríguez, CEO, and Co-Founder at La Garrocha, highlights the complexity of managing inventory, especially when dealing with multiple sizes per garment. He expressed his trust in Naiz Fit, stating,

“We rely on experience and place significant trust in Naiz Fit. We continuously monitor the Naiz Fit dashboard to see which size recommendations have been requested per item. Based on this analysis, we optimize inventory purchases to ensure customers have the sizes and styles they want while also increasing our turnover and minimizing unsold inventory.” ⁽²⁶⁾

This demonstrates how Naiz Fit has not only improved customer experiences but also revolutionized the backend processes, making inventory management more efficient and cost-effective.

A Vision for the Future

Ronen Luzon, Founder and CEO of My Size, Inc. (Nasdaq: MYSZ), emphasizes the broader impact of this partnership, saying,

The triumph of La Garrocha serves as a dynamic testament to the remarkable advantages unlocked by My Size’s apparel sizing solutions for apparel retailers, customers, and environmental sustainability. Through this collaboration, we hope to redefine industry standards while amplifying My Size’s role in fueling business growth for our customers.” ⁽²⁶⁾

The success story of La Garrocha and My Size, Inc. illustrates the power of technology in transforming traditional businesses. Naiz Fit not only improves customer satisfaction and conversion rates but also brings tangible benefits to inventory management. As businesses continue to adapt to the digital age, partnerships like these are poised to reshape the retail landscape and drive innovation across industries. ⁽²⁶⁾

My Size, Inc. (Nasdaq: MYSZ) recently unveiled its impressive financial results for the second quarter of 2023. The company’s remarkable performance is primarily attributed to the robust growth seen at Orgad, alongside the successful acquisition of Naiz Fit. Let’s delve into the key financial and operational highlights of this thriving company. ⁽²⁵⁾

A Look at the Financials

Consolidated Revenue Soars: My Size, Inc. (Nasdaq: MYSZ) reported a staggering 61% increase in consolidated revenue, reaching a total of $1,290,000 for the three months ended June 30, 2023. This surge in revenue is chiefly attributed to the growth witnessed at Orgad and the strategic acquisition of Naiz Fit. ⁽²⁵⁾

Gross Profit Follows Suit: Mirroring the impressive revenue growth, gross profit also witnessed a significant 61% increase, reaching $519,000 during the same period.

Stable Gross Profit Margin: Despite the substantial growth in revenue and gross profit, the company managed to maintain a stable gross profit margin, which stood firm at 40%.

Cost of Revenues: As expected with growing operations, the cost of revenues also increased by 61%, totaling $771,000 for the second quarter of 2023.

Operational Improvements: My Size, Inc. (Nasdaq: MYSZ) demonstrated effective cost management, as reflected in a 6% reduction in operating loss, which amounted to $1,554,000 for the quarter.

Net Loss Narrows: The company experienced a significant 25% reduction in net loss, with figures narrowing down to $1,291,000 for the three months ended June 30, 2023.

Healthy Inventory Balance: As of June 30, 2023, the company maintained an inventory balance of $1,043,000, indicating prudent inventory management practices. ⁽²⁵⁾

Operational Highlights

Expanding User Base: My Size, Inc. (Nasdaq: MYSZ) and Naiz Fit SaaS apparel sizing solutions achieved remarkable milestones during the second quarter. The platform served 5 million end users worldwide, made 35.6 million size recommendations, and facilitated the purchase of 17.9 million items through 7 million orders.

Reducing Returns: My Size, Inc. (Nasdaq: MYSZ)’s solutions led to an impressive reduction of up to 65% in size-related returns compared to shoppers who did not utilize these sizing solutions at the same online stores.

Lucrative Revenues: The company generated €790 million worth of sales to Naiz Fit and MySizeID users, highlighting the substantial revenue potential of its solutions.

SaaS Revenue Growth: SaaS revenues from My Size, Inc. (Nasdaq: MYSZ), Naiz Fit, and Smart Catalog more than doubled compared to the first quarter of 2022, indicating the increasing adoption and effectiveness of these solutions.

Orgad’s Success: Orgad, a key subsidiary, achieved substantial sales growth in the first half of 2023, particularly on Amazon, with sales reaching $1.74 million. Orgad strategically shifted to utilizing Fulfillment by Amazon (FBA), reducing inventory risk and enhancing operating efficiencies.

Global Expansion: Luxury Italian menswear fashion brand Canali adopted the Naiz Fit sizing solution across all 32 of its e-commerce sites in Europe and the U.S., demonstrating the wide applicability and appeal of My Size’s offerings. ⁽²⁵⁾

Management Perspective

Ronen Luzon, the Founder and CEO of My Size, Inc. (Nasdaq: MYSZ), expressed confidence in the company’s strength and growth trajectory, emphasizing the following points:

• Robust revenue growth coupled with decreasing operational costs during the second quarter.
• Enhanced profitability at Orgad through advanced AI tools and strategic sales outreach in North America.
• Impressive results from SaaS-based apparel sizing solutions, including reduced returns, higher conversions, and increased sales.
• Continued reduction in R&D spending while recurring revenues continue to rise.
• Capitalizing on synergies across business segments by reallocating resources to Naiz Fit’s operations hub in Spain.
• Expectation of continued robust revenue growth and improved operating efficiencies, moving towards cash flow positivity in the remainder of 2023.

My Size, Inc. (Nasdaq: MYSZ) has demonstrated remarkable growth and resilience in the second quarter of 2023. With substantial increases in revenue, gross profit, and a narrowing of losses, the company is on a path of sustained success. Their innovative sizing solutions, impressive partnerships, and strategic acquisitions have positioned them as a prominent player in the e-commerce industry. As they continue to expand their user base and drive efficiency across their operations, My Size, Inc. (Nasdaq: MYSZ) is poised for a promising future in the world of AI-driven measurement solutions. (25)

NEWS

PUBLISHED

SEP 7, 2023

MYSIZE TO PRESENT AT H.C. WAINWRIGHT 25TH ANNUAL GLOBAL INVESTMENT CONFERENCE

PUBLISHED

AUG 23, 2023

MYSIZE’S NAIZ FIT SIZING SOLUTION NAMED ONE OF THE TOP ECOMMERCE TOOLS IN SPAIN

PUBLISHED

AUG 17, 2023

SPANISH FASHION BRAND LA GARROCHA BOOSTS INVENTORY MANAGEMENT AND REVENUES WITH AI-POWERED NAIZ FIT FROM MYSIZE

PUBLISHED

AUG 14, 2023

MYSIZE REPORTS SECOND QUARTER 2023 FINANCIAL RESULTS

PUBLISHED

AUG 10, 2023

MYSIZE’S APPAREL SIZING SOLUTIONS ACHIEVE KEY MILESTONES: 35 MILLION SIZE RECOMMENDATIONS WITH 18 MILLION ITEMS SOLD WORTH €790 MILLION

PUBLISHED

MAY 15, 2023

MYSIZE REPORTS FIRST QUARTER 2023 FINANCIAL RESULTS

PUBLISHED

APR 26, 2023

MYSIZE TO PRESENT AT LADENBURG THALMANN TECH EXPO ON APRIL 27, 2023 IN NEW YORK CITY

PUBLISHED

APR 24, 2023

LUXURY ITALIAN MENSWEAR FASHION BRAND CANALI IMPLEMENTS MYSIZE’S NAIZ FIT SIZING SOLUTION

PUBLISHED

APR 19, 2023

MYSIZE TO PRESENT AT THE SEQUIRE INVESTOR SUMMIT IN PUERTO RICO

PUBLISHED

APR 18, 2023

MYSIZE TO EXHIBIT AT THE RETAIL TECHNOLOGY SHOW 2023 IN LONDON

PUBLISHED

APR 14, 2023

MYSIZE REPORTS 2022 FULL-YEAR FINANCIAL RESULTS: MEETS REVENUE GUIDANCE OF $4.5 MILLION

PUBLISHED

APR 6, 2023

WITH Q3 REVENUES GROWING 2242%, MYSIZE ANTICIPATES STRONG FULL-YEAR GROWTH WITH $4-$5 MILLION IN REVENUES AS IT PREPARES TO RELEASE 2022 YEAR-END FINANCIALS

SINCERELY,

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Source 1: https://mysizeid.com/mysizeid-app/
Source 2: https://coresight.com/research/the-true-cost-of-apparel-returns-alarming-return-rates-require-loss-minimization-solutions/
Source 3: https://www.barchart.com/stocks/quotes/MYSZ/price-history/historical?orderBy=highPrice&orderDir=desc
Source 4: https://finviz.com/quote.ashx?t=MYSZ&p=d
Source 5: https://mysizeid.com/reports/mysize-to-exhibit-at-the-retail-technology-show-2023-in-london/
Source 6: https://mysizeid.com/reports/mysizeid-for-pets-mysize-to-launch-ai-driven-sizing-solution-for-5-billion-pet-clothing-market/
Source 7: https://mysizeid.com/reports/mysize-reports-first-quarter-2023-financial-results/
Source 8: https://www.precedenceresearch.com/artificial-intelligence-market
Source 9: https://schrts.co/xBVZFHbB
Source 10: https://www.state.gov/wp-content/uploads/2021/06/AI-Motherboard-scaled.jpg
Source 11: https://mysizeid.com/mysize-tech/
Source 12: https://miro.medium.com/v2/resize:fit:1000/1*mp6XQVziN3SnFoR94aEPzg.jpeg
Source 13: https://fashionweekonline.com/wp-content/uploads/2021/02/karsten-winegeart-featured-1.jpg
Source 14: https://www.rlmedia.io/is/image/PoloGSI/s7-1370663_lifestyle?$plpDeskRF$
Source 15: https://mysizeid.com/reports/mysize-reports-2022-full-year-financial-results-meets-revenue-guidance-of-4-5-million/
Source 16: https://www.youtube.com/watch?v=RzD7btn76cs
Source 17: https://www.youtube.com/watch?v=4K9rOTsgo8A
Source 18: https://mysizeid.com/sizeup/
Source 19: https://www.youtube.com/watch?v=AamDzCDOeOA
Source 20: https://mma.prnewswire.com/media/700474/MySize_Logo.jpg?p=twitter
Source 21: https://www.benzinga.com/quote/MYSZ/analyst-ratings
Source 22: https://finance.yahoo.com/news/unpacking-value-trap-deep-dive-154122134.html
Source 23: https://www.sofi.com/learn/content/understanding-low-float-stocks/
Source 24: https://investmentu.com/low-float-stocks/
Source 25: https://finance.yahoo.com/news/mysize-reports-second-quarter-2023-130000788.html
Source 26: https://finance.yahoo.com/news/spanish-fashion-brand-la-garrocha-130000841.html

_______

OUR NEW PROFILE IS:   (NASDAQ: INM)

______

INM HAS A FLOAT OF 3.3 MILLION WITH $9.6MILL IN CASH (MARCH, 21 2023) AND $2.3MILL IN Q4 REVENUES!!  (UNAUDITED)

LAST 2 PERIODS SHOW A MASSIVE 123%(UNAUDITED) AND 120% QUARTER OVER QUARTER GROWTH 

TOTAL REVENUES OF $4.1M (UNAUDITED) IN FISCAL YEAR 2023, REPRESENTING A 276% INCREASE OVER THE PREVIOUS FISCAL YEAR

A CLINICAL STAGE COMPANY WITH A ROBUST PIPELINE OF PHARMA PROGRAMS IN DERMATOLOGY, OCULAR AND ALZEIMERS

READ THE INVESTOR PRESENTATION HERE

________________

Hello Everyone,

Up next is an extremely unique hybrid clinical stage pharmaceutical  company.  They have several pharmaceutical programs supported by a revenue generating business.  If this kind of growth continues then they have the possibility of being a self funded pharma company.

Pull up INM right away and start your research on it.

Recently we have witnessed a surge in MJ companies on the back of The Drug Enforcement Agency (DEA) considering reclassifying marijuana as a Schedule III drug, placing it alongside substances like ketamine, anabolic steroids, and testosterone. This classification implies a moderate to low potential for physical or psychological dependence. This recommendation does not entail complete removal from the controlled substances list however it will be a huge advantage for MJ companies and pharmaceutical companies like INM that are not MJ companies, however, they are aligned with the Cannabis markets.  INM is already listed on the Nasdaq and does not have to navigate the tricky banking regulations often associated with these types of companies.

The new classification could benefit MJ companies in a few ways.

Marijuana businesses currently face restrictions under IRS code 280E, preventing them from deducting expenses on federal tax returns. Reclassification could alleviate this burden. Rescheduling could enable legal interstate commerce, addressing the challenge of transporting marijuana across state lines, opening up new lines of business.   It would also open doors for increased research in the marijuana sector, potentially attracting investors and driving the MJ market higher.

InMed Pharmaceuticals is a global leader in the research, development and manufacturing of rare cannabinoids, including clinical and preclinical programs targeting the treatment of diseases with high unmet medical needs. They also have significant know-how in developing proprietary manufacturing approaches to produce cannabinoids for various market sectors.

Things appear to be heading in the right direction for INM if you look at the numbers.  The company has had to optimize and scale up the manufacturing processes over the last 12 months to meet increasing demand.  InMed’s BayMedica subsidiary delivered $4.1 Million in revenue in fiscal 2023 (unaudited) including $1.8 million in rare cannabinoid ingredient sales to distributors and manufacturers in the H&W sector in the first 9 months of the fiscal year, compared to $0.6 million in all of 2022.  Q4 financial are expected to post in the coming weeks.  If similar growth continues then we could potentially see INM become a self funded Pharma company.

Another major catalyst is the valuation gap.  If you look at the current market cap it is a mere fraction of the cash position.  We often see companies valued at multiples of current revenues.  That is certainly not the case with INM.  The market cap is below $3Mill with Q4 (Unaudited) revenues of 2.3 Mill and growing.  All this without even taking into account the current pharmaceutical pipeline.   These components could be major factors towards the growth of this company from it’s current levels.

According to a recent analyst report, rare cannabinoids in demand. After hitting some earlier speed bumps following its acquisition by InMed in October 2021, BayMedica’s revenue growth profile in the last three quarters offers evidence that select rare cannabinoids led by cannabichromene (CBC), BayMedica’s leading product, are starting to make their mark as ingredients of growing importance in health and wellness products. A better understanding and growing awareness of the health benefits of rare cannabinoids are evidenced by leading consumer health companies expanding their product lines to include new formats and formulations using rare cannabinoids. It is important to note that the health and wellness sector remains very much an under-penetrated market for rare cannabinoids. According to data and market intelligence firm Headset.io. While global CBC sales totaled $1.7M in 2022, sales for the more established rare cannabinoids such as CBN and CBG were $187M and $55M respectively, highlighting CBC’s growth. Global sales of major cannabinoid CBD are running at ~$5B (of which half are B2B sales) is perhaps an indicator of the potential market size for rare cannabinoids. 

BayMedica’ positioning in the market is being wellexecuted.  BayMedica is uniquely positioned to meet the fast-growing demand for rare cannabinoids. Its manufacturing processes and global supply chain allow it to cost-effectively scale up its supply of high-quality rare cannabinoids, as evidenced by its recent growth profile. BayMedica has the unparalleled ability to potentially scale production to metric tons as demand continues to rise.

RINMED PHARMACEUTICALS INC. ANNOUNCES RESULTS FROM A PHASE 2 CLINICAL TRIAL IN EPIDERMOLYSIS BULLOSA

• An exploratory clinical evaluation of the Phase 2 clinical trial data showed a positive indication of enhanced anti-itch activity for INM-755 cannabinol (“CBN”) cream versus the control cream alone.
• The results for non-wound itch were not statistically significant in favor of INM-755 CBN cream due, in part, to the clinically important anti-itch effect of the underlying control cream.
• INM-755 CBN cream demonstrated a favorable safety and tolerability profile.
• InMed will pursue strategic partnership opportunities for INM-755 in epidermolysis bullosa (“EB”) and other itch-related skin conditions.

Vancouver, BC – June 22, 2023 – InMed Pharmaceuticals Inc. (“InMed” or the “Company”) (Nasdaq: INM), a leader in the pharmaceutical research, development, manufacturing and commercialization of rare cannabinoids and cannabinoid analogs, today announced safety and efficacy results from its Phase 2 clinical trial, called 755-201-EB (the “Phase 2 Trial”), for the treatment of symptoms related to EB.

The purpose of the Phase 2 Trial was to evaluate the safety of INM-755 CBN cream, which consists of the control cream plus the active pharmaceutical ingredient CBN, and obtain preliminary evidence of efficacy in treating symptoms and healing wounds over a 28-day period in patients with EB. All four subtypes of inherited EB, including EB Simplex, Dystrophic EB, Junctional EB, and Kindler Syndrome were accepted into the Phase 2 Trial. The Phase 2 Trial used a within-patient, double-blind design whereby matched index areas were randomized to INM-755 CBN cream or control cream.

The Phase 2 Trial enrolled a total of 19 patients. Data from one patient were excluded from efficacy analyses due to a significant protocol deviation. Of the 18 remaining patients whose data were considered reliable for clinical review, 17 were treated for chronic non-wound itch and one patient was treated for wound-related itch. The remaining endpoints (pain, wound healing) could not be analyzed due to too few enrollees with such symptoms.

Of the 18 participants assessed, chronic itch improved by a clinically meaningful amount in 12 patients (66.7%), of whom:

• 6 patients (33.3%) had the same level of itch improvement with INM-755 cream as with control cream;
• 5 patients (27.8%) treated with INM-755 showed meaningful anti-itch activity beyond that of the control cream; and
• 1 patient (5.6%) showed better itch reduction with the control cream.

However, the protocol-specified statistical analyses for non-wound itch were not statistically significant in favor of INM-755 due in part to the clinically important anti-itch effect of the underlying control cream.

As expected based on a Phase 1 safety study (755-101-HV) undertaken by the Company, systemic exposure of CBN was measured at very low concentrations (picograms/mL in plasma). There were no serious drug-related adverse events (“AEs”) and there were no withdrawals from treatment. Moderate headaches in one study participant were the only systemic AEs deemed ‘possibly related’ to study drug. Very few local AEs were reported in the treatment areas; they were transient and resolved without cessation of treatment. The Phase 2 Trial indicated that INM-755 CBN cream was very well tolerated on sensitive EB skin.

“This is an important day for the Company, as we report that INM-755 CBN cream demonstrated sufficient clinically important anti-itch activity to warrant further development. We are very encouraged that INM-755 CBN cream could someday provide itch relief for patients with EB and possibly other diseases,” commented Alexandra Mancini, SVP of Clinical and Regulatory Affairs at InMed. “We are deeply grateful for all of the individuals with EB and their families who participated in the study and for the investigators and clinical team who conducted this trial.”

InMed’s CEO, Eric A. Adams, added, “Despite many challenges associated with conducting an international clinical trial in an orphan disease, compounded by COVID-related disruptions, the InMed and clinical research organization joint team, led by Ms. Mancini, persevered to see this trial through to conclusion. Based on the safety and efficacy data for treating non-wound itch in this EB study, as well as previous safety data from Phase 1 trials, InMed will now seek R&D and commercial partnership opportunities for any continued development of INM-755 CBN cream.”

Learn more about InMed’s INM-755 EB program: https://www.inmedpharma.com/pharmaceutical/inm-755-for-epidermolysis-bullosa/

MANUFACTURING & COMMERCIAL

INM is currently using modern manufacturing approaches to produce rare cannabinoids economically so they can be used in products for the health and wellness industry. Rare cannabinoids unlike CBD and THC are very difficult to grow and extract economically- InMed solve for that issue.  They are well positioned once big consumer goods companies start entering the space and need pure, consistent, economic ingredients at scale.

INMED PROVIDES UPDATE ON BAYMEDICA RARE CANNABINOID BUSINESS

• $2.3M revenues (unaudited) in Q4 2023, representing 123% increase quarter over quarter (“QoQ”)
• Optimized and scaled up manufacturing processes over the last 12 months to meet increasing demand
• Third consecutive quarter with significant revenue growth

Vancouver, British Columbia–(Newsfile Corp. – July 20, 2023) – InMed Pharmaceuticals Inc. (NASDAQ: INM) (“InMed“), a leader in the pharmaceutical research, development, manufacturing and commercialization of rare cannabinoids and cannabinoid analogs, today provided a commercial and manufacturing update on its subsidiary BayMedica LLC (“BayMedica“), a leading supplier of bioidentical rare cannabinoids to the Health and Wellness (“H&W”) market.

“We are very encouraged to see another strong quarter with (unaudited) revenues in excess of $2.3M, representing our third consecutive quarter with significant revenue growth,” said Eric A. Adams, InMed’s President and CEO. He added, “As demand for minor cannabinoids continues to increase, we see a potential path for BayMedica to become a profitable standalone business subsidiary and contribute margin to the pharmaceutical R&D parent.”

BayMedica Growing Revenue (Unaudited)

• $2.3M in revenue for the three months ended June 30, 2023, a 123% increase QoQ.
• Third consecutive quarter of strong revenue growth and the second consecutive quarter with growth exceeding 100% QoQ.
• Total revenues of $4.1M in fiscal year 2023, representing a 276% increase over the previous fiscal year.

Supply Chain Optimization
As revenues have grown steadily over the past several months, BayMedica has been diligently working to ensure sufficient inventory to meet the increasing demand of its bioidentical rare cannabinoids. BayMedica has been focused on creating redundancy at both ends of the supply chain by securing more sources of raw materials as well as securing additional downstream purification partners. In addition, BayMedica has recently hired a director for manufacturing and logistics to oversee the supply chain function and manage third party vendors.

Increased Production
BayMedica, through its manufacturing partners, has steadily increased manufacturing throughput to maintain supply of finished goods to meet customer demand over the last 12 months. With completed and ongoing process improvements, BayMedica has the capability to potentially scale production to metric tonnes (thousands of kilograms) should demand continue to rise.

Product Portfolio
BayMedica is a leading high quality, low cost supplier of non-intoxicating bioidentical rare cannabinoids for the H&W sector: cannabichromene (CBC), delta-9 tetrahydrocannabivarin (THCV), cannabidivarin (CBDV) and cannabicitran (CBT). BayMedica continues to optimize its manufacturing processes and supply chain logistics to reduce the overall cost of goods, while also improving the already high quality and purity levels for all products in its portfolio.

“We have seen demand for rare cannabinoids surge over the past year, and we are pleased to have been able to increase production to meet the needs of our customers,” commented Shane Johnson, General Manager of BayMedica. “We attribute the increasing demand, in part, to better research of rare cannabinoids, companies and brands looking for product innovation and effects-based outcomes, and the ability of companies like ours to be able to reliably supply high quality rare cannabinoids with low batch-to-batch variations. We are pleased to have established ourselves as a leading supplier of rare cannabinoids in this fast-growing yet still nascent market.”

Although InMed experienced revenue growth for the fourth quarter in the BayMedica segment, management expects to report an overall net loss for the year ended June 30, 2023. InMed plans to file a 10-K with audited financial statements, including audited revenue figures, in the second half of September 2023.

INMED PHARMACEUTICALS REPORTS THIRD QUARTER FISCAL 2023 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE

• Completed enrollment in Phase 2 Clinical Trial; data readout expected during calendar 3Q 2023
• 120% quarter-over-quarter revenue growth in the commercial BayMedica subsidiary
• Published a peer-reviewed study showing the anti-inflammatory potential of rare cannabinoids

Vancouver, British Columbia–(Newsfile Corp. – May 15, 2023) – InMed Pharmaceuticals Inc. (NASDAQ: INM) (“InMed” or the “Company“), a leader in the pharmaceutical research, development, manufacturing and commercialization of rare cannabinoids and cannabinoid analogs, today announced financial results for the third quarter of the fiscal year 2023 (“FY 3Q23”) which ended March 31, 2023.

The Company’s full financial statements and related MD&A for the third quarter ended March 31, 2023, are available at www.inmedpharma.com, www.sedar.com and at www.sec.gov.

“The third quarter of fiscal year 2023 was an important period for InMed, as we achieved several key milestones across our different business segments, including completing enrollment in our Phase 2 clinical trial for epidermolysis bullosa, marking the first time cannabinol (“CBN”) has completed a Phase 2 clinical trial. We look forward to the data read out during 3Q and will then be in a better position to evaluate our strategic opportunities for the program,” said Eric A. Adams, President and CEO of InMed. “We are increasingly excited about the data we are seeing in our preclinical ocular and neurodegenerative disease programs where we are researching proprietary cannabinoid analogs in the treatment of various indications.”

“We also hit another significant milestone in our commercial BayMedica subsidiary, surpassing $1M in quarterly revenues for the first time from the sales of rare cannabinoids to the Health and Wellness (“H&W”) sector, representing a 120% increase over 2Q sales.” Adams continued, “In the last few months we have seen a noticeable increase in awareness, understanding and adoption of rare cannabinoids in the H&W sector, evidenced by leading companies expanding their product lines to include new formats and formulations using rare cannabinoids such as the non-psychoactive ingredient cannabichromene (“CBC”). We are encouraged by two consecutive periods of significant quarter over quarter revenue growth. We will continue to support growth in a fiscally prudent manner in this relatively nascent market, where product demand can be unpredictable. The combination of a pharmaceutical drug development pipeline, together with a revenue generating commercial operation that will be contributing to extending our cash runway makes InMed a unique company within the rare cannabinoid space.”

Business update

Pharmaceutical Development Programs

INM-755 – Phase 2 Clinical Trial in EB

In March 2023, the Company concluded enrollment of 19 patients in its Phase 2 clinical trial, with the last patient completing treatment in April, using the investigational drug INM-755 CBN cream for the treatment of symptoms in persons with epidermolysis bullosa (“EB”), a rare genetic skin disease. The study used a within-patient, double-blind design in which matched index areas were randomized to INM-755 (cannabinol) cream or vehicle cream as a control. Selected matched index areas may have been wounds or non-wound areas. In this study, designed to measure safety and obtain preliminary evidence of efficacy, there is no single primary efficacy endpoint. Net benefit from INM-755 cream will be evaluated within each patient and based on their clinical needs at baseline. Based on their presenting symptoms, the majority of the enrolled and treated patients in the 755-201-EB study were treated for non-wound itch.

INM-088 – Glaucoma Program

The Company continues to conduct IND-enabling preclinical testing for the development of a CBN-based eye drop formulation in glaucoma and has planned GLP toxicology studies in Q4 2023.

As part of the Company’s proprietary cannabinoid analog program, InMed continues to screen a library of new compounds across a spectrum of therapeutic applications, including other ocular indications such as Age-related Macular Degeneration (“AMD”) and other similar ‘back-of-the-eye’ diseases.

INM-900 – Neurodegenerative Diseases Program

Two cannabinoid analogs are being assessed in in vivo models of neurodegenerative diseases and the Company expects these studies to be completed and a candidate selected for further development in calendar 2Q 2023. Our research demonstrated the neuroprotective effects of specific cannabinoid analogs and their potential to improve neuronal function in in vitro testing.

InMed recently filed a patent application covering a range of cannabinoids demonstrating neuroprotection and enhanced neuronal function for the potential treatment of neurodegenerative diseases such as Alzheimer’s Disease, Parkinson’s Disease, Huntington’s Disease and others.

Publications

In March 2023, the Company announced the publication of a peer-reviewed scientific study entitled “Rare phytocannabinoids exert anti-inflammatory effects on human keratinocytes via the endocannabinoid system and MAPK signaling pathway” in the International Journal of Molecular Sciences. The study, conducted in collaboration with Dr. Mauro Maccarrone at the Università degli Studi dell’Aquila, Italy, investigates the dermatological anti-inflammatory effects of certain rare cannabinoids. It is the second Company-sponsored study to demonstrate the anti-inflammatory effects of rare cannabinoids and their potential for the treatment of skin conditions such as atopic dermatitis, psoriasis, pruritus, and acne.

BayMedica Commercial Business

InMed’s BayMedica rare cannabinoids business, which serves the H&W sector, delivered its strongest revenue quarter since acquisition in late 2021. As a result of slower than anticipated product demand throughout 2022, in 2023, management took a conservative approach towards investment in inventory and new products while the sales and marketing function sought to develop commercial opportunities.

This approach has proven beneficial as, thus far in 2023, the H&W sector has experienced a significant increase in demand for rare cannabinoids, particularly CBC, where BayMedica has been well-positioned to be a key supplier to distributors and manufacturers. During the nine months ended March 31, 2023, revenues totaled more than $1.8 million, as sales surpassed $1 million in the third quarter alone, compared to $0.6 million for the nine months ended March 31, 2022.

While the medium- and long-term outlooks remain uncertain, sales and marketing efforts remain focused on products that have stable pricing, lower manufacturing costs, and where BayMedica holds a strong competitive position.

Financial and Operational Highlights:

For the nine months ended March 31, 2023, the Company recorded a net loss of $7.6 million, or $3.53 per share, compared with a net loss of $10.7 million, or $20.13 per share, for the nine months ended March 31, 2022.

Research and development and patents expenses decreased by $2.7 million for the nine months ended March 31, 2023 compared to the same period in 2022. The decrease was due to a combination of lower personnel expenses and high start-up costs associated with the multicenter Phase 2 clinical trial in our INM-755 program during fiscal 2022.

The Company incurred general and administrative expenses of $4.4 million for the nine months ended March 31, 2023 compared with $5.1 million for the nine months ended March 31, 2022. The decrease results primarily from a combination of changes including lower personnel expenses, insurance fees, investor relation expenses, accounting fees, legal fees and were offset by the inclusion of BayMedica operating results following its acquisition on October 13, 2021.

At March 31, 2023, the Company’s cash, cash equivalents and short-term investments were $9.6 million, which compares to $6.2 million at June 30, 2022. The increase in cash, cash equivalents and short-term investments during the nine months ended March 31, 2023, was primarily the result of both the September 13, 2022 and November 21, 2022 private placements partially offset by cash outflows from operating activities. With ongoing revenue from the BayMedica operations and depending on how we prioritize investment into our various development activities, InMed has a projected cash runway to the middle of fiscal 3Q 2024.

At March 31, 2023, the Company’s total issued and outstanding shares were 3,328,191. During the three and nine months ending March 31, 2023, the weighted average number of common shares was 3,328,191 and 2,156,283, which is used for the calculation of loss per share for the respective interim periods.

For the nine months ending March 31, 2023, InMed’s BayMedica subsidiary delivered $1.8 million in rare cannabinoid ingredient sales to distributors and manufacturers in the H&W sector, compared to $0.6 million in 2022, reflecting expanded marketing efforts and increased market demand. Gross profit margin was adversely affected by downward pricing pressure on certain products in the portfolio and a write-down of selected inventories to net realizable value of $0.6 million in the first quarter of 2023. We expect our overall gross profit and gross profit margins will improve over the coming quarters as sales and marketing efforts are focused on products with more stable pricing and lower manufacturing costs.

NEWS

INMED TO PRESENT AT H.C. WAINWRIGHT 25TH ANNUAL GLOBAL INVESTMENT CONFERENCE

September 7, 2023

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INMED TO PARTICIPATE IN FIRESIDE CHAT WITH WATER TOWER RESEARCH ON JULY 25, 2023 AT 2PM ET

July 21, 2023

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INMED PROVIDES UPDATE ON BAYMEDICA RARE CANNABINOID BUSINESS

July 20, 2023

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INMED PHARMACEUTICALS INC. ANNOUNCES RESULTS FROM A PHASE 2 CLINICAL TRIAL IN EPIDERMOLYSIS BULLOSA

June 22, 2023

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INMED’S NEURODEGENERATIVE DISEASE STUDY PRESENTED AT CANADIAN NEUROSCIENCE MEETING

June 1, 2023

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INMED TO PARTICIPATE IN UPCOMING VIRTUAL INVESTOR EVENTS

May 24, 2023

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INMED TO PARTICIPATE IN FIRESIDE CHAT WITH WATER TOWER RESEARCH ON MAY 23, 2023 AT 1PM ET

May 18, 2023

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INMED PHARMACEUTICALS REPORTS THIRD QUARTER FISCAL 2023 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE

May 15, 2023

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INMED ANNOUNCES CONCLUSION OF PATIENT ENROLLMENT IN PHASE 2 CLINICAL TRIAL INVESTIGATING INM-755 CANNABINOL CREAM FOR EPIDERMOLYSIS BULLOSA

March 28, 2023

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INMED ANNOUNCES PUBLICATION OF PEER-REVIEWED STUDY SHOWING THE ANTI-INFLAMMATORY POTENTIAL OF RARE CANNABINOIDS IN SKIN CONDITIONS

March 13, 2023

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INMED TO PARTICIPATE IN UPCOMING INVESTOR EVENTS

March 7, 2023

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INMED REPORTS SECOND QUARTER FISCAL 2023 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE

February 17, 2023

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INMED SUBMITS FORM 12B-25

February 9, 2023

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INMED PROVIDES BUSINESS UPDATE AND MILESTONES FOR 2023

January 10, 2023

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INMED ANNOUNCES RESULTS OF 2022 ANNUAL GENERAL MEETING

December 15, 2022

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INMED ANNOUNCES APPOINTMENT OF INTERIM CHIEF FINANCIAL OFFICER AND CHANGE OF AUDITOR

December 12, 2022

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INMED PHARMACEUTICALS ANNOUNCES CLOSING OF $6 MILLION PRIVATE PLACEMENT PRICED AT A PREMIUM TO MARKET

November 21, 2022

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INMED PHARMACEUTICALS ANNOUNCES $6 MILLION PRIVATE PLACEMENT PRICED AT A PREMIUM TO MARKET

November 18, 2022

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INMED PROVIDES UPDATE ON MANAGEMENT CHANGES

November 17, 2022

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INMED PHARMACEUTICALS ADVANCES NEURODEGENERATIVE DISEASE PROGRAM WITH NATURAL SCIENCES AND ENGINEERING RESEARCH COUNCIL OF CANADA (“NSERC”) ALLIANCE GRANT FUNDING

November 16, 2022

Read More »

INMED PHARMACEUTICALS REPORTS FIRST QUARTER FISCAL 2023 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE

November 11, 2022

Read More »

MANAGEMENT

ERIC A. ADAMS, MIBS

Chief Executive Officer & President

Eric A. Adams was appointed Chief Executive Officer, President and Director of InMed Pharmaceuticals, Inc. in June 2016. During his tenure at InMed, he has reconstituted the Board of Directors and the Executive management team and has raised more than $35M in

capital to fund operations. Mr. Adams is a seasoned biopharmaceutical executive with more than 25 years of experience in establishing corporate entities, capital formation, global market development, mergers & acquisitions, licensing and corporate governance.

Mr. Adams previously served as CEO at enGene Inc., where he oversaw its transformation from a nascent start-up into a venture capital-backed leader in gene therapy. Prior to enGene, Mr. Adams held senior positions in global market development with QLT Inc. (Vancouver), Advanced Tissue Sciences Inc. (La Jolla, CA), Abbott Laboratories (Chicago, IL), and Fresenius AG (Germany). As the previous Chairman of BIOTECanada’s Emerging Company Advisory Board, and for his extensive generosity in mentoring biotech entrepreneurs, Mr. Adams is well-respected within the Canadian biotech industry as a strategic advisor to a number of early-stage biotech companies.

He is a dual citizen of Canada and the United States, and holds a Masters of International Business from the University of South Carolina and a Bachelor’s Degree in Chemistry from the University of Southern Indiana.

MICHAEL WOUDENBERG, P.ENG.

Chief Operating Officer

Mr. Woudenberg joined InMed with more than 20 years of successful drug development, process engineering, GMP manufacturing and leadership experience. He brings valuable expertise in the development, technology transfer and commercialization of

active pharmaceutical ingredients (APIs) and drug products.

Prior to joining InMed in 2018, Mr. Woudenberg held various positions within 3M, Cardiome Pharma, Arbutus Biopharma and most recently as the Managing Director of Phyton Biotech, LLC. His experience includes process and formulation development from lab/pre-clinical products through the various stages of clinical development to validated and successfully approved and inspected commercial APIs and drug products. Additionally, he has extensive experience with regards to regulatory inspections (e.g. FDA, European, Australian, Korean, Japanese, Canadian) and their related chemistry, manufacturing and control requirements from clinical to commercial production of approved products.

Mr. Woudenberg received his Bachelor of Science, Chemistry and Bachelor of Engineering Science, Chemical at Western University of London, Ontario, Canada.

ALEXANDRA D.J. MANCINI, MSC

Senior Vice President, Clinical & Regulatory Affairs

Ms. Mancini has more than 30 years of global biopharmaceutical R&D experience, overseeing a wide range of drug development activities, with a particular emphasis on clinical development and regulatory affairs. She has been an executive with numerous biotech

companies, including Sr. V.P. of Clinical & Regulatory Affairs at Sirius Genomics, where her responsibilities included identifying and managing external resources for medical expertise in sepsis, clinical data management and statistical theory, programming and analyses.

Prior to joining Sirius Genomics, Ms. Mancini served as Sr. V.P. of Clinical & Regulatory Affairs at INEX Pharmaceuticals; and V.P. of Regulatory Affairs at QLT Inc., where she played a significant role in the development of VISUDYNE from the preclinical stage through to its approval as the first drug for age-related macular degeneration. While at QLT, Ms. Mancini also led the regulatory approval process for the anti-cancer drug PHOTOFRIN and its associated medical devices, the first drug-device combination product approved by the U.S. Food and Drug Administration.

Ms. Mancini holds a Master of Science degree from the University of Toronto.

ERIC C. HSU, PHD

Senior Vice President, Pre-Clinical Research & Development

Dr. Hsu joined InMed with more than 18 years of scientific leadership experience in the field of gene therapy. Prior to joining InMed, he held various positions within enGene Inc., including V.P. of Research and V.P. of Scientific Affairs and Operations.

Dr. Hsu’s experience includes a wide array of activities, including benchtop research, formulation development and manufacturing process development, as well as patent prosecution, vendor contract negotiations and execution, and research partnerships. He is also responsible for expanding product pipelines, and managing R&D budgets and timelines. Dr. Hsu is considered to be an expert in gene transfer and gene expression using vector systems.

Dr. Hsu received his Doctorate from the Department of Medical Biophysics at the University of Toronto and his Bachelor’s degree from McGill University.

SINCERELY,

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OUR NEW PROFILE IS: (NASDAQ: LYT)

THE FLOAT ON LYT IS A MERE 8.67 MILL SHARES.……. IT IS SITTING UNDER .35 RIGHT NOW!!

LYTUS TECHNOLOGIES ENTERS FINTECH SPACE WITH THE LAUNCH OF A NEW PAYMENT GATEWAY IN INDIA

LYTUS HAS OVER 4 MILLION ACTIVE USERS, EXCLUSIVE ACCESS TO OVER 5000 KILOMETERS (3106 MILES), AND REPORTED $19 MILLION IN REVENUE FOR FINANCIAL YEAR-END MARCH 31, 2023

HELLO EVERYONE,

We have another profile for Thursday that we feel you should research immediately.

This is a company looks like it could have potential for a strong bounce based on the reported structure and price.

Pull up LYT immediately.

Lytus Technologies Holdings PTV. Ltd. is a growing platform services company. The Company’s business model consists primarily of distribution of linear content streaming/telecasting services and development of telemedicine products. They are a rapidly expanding technology-driven internet platform services organization with operations in India and USA. The company offers high-value streaming and telemedicine services to over 4 million active users and monthly customers across India and USA. The firm is one of India’s fastest-growing online content and streaming service providers. Through its 5,000-kilometer network of installed fibre and broadband infrastructure, the firm delivers fibre and broadband services to its client base. Currently, Lytus Technologies has nationwide Telecast & Multicast services in India providing retail and commercial customers monthly subscription-based linear video and Internet services.

There are a few main catalysts to look at for Wednesdays session.

• With A Low Float we could see some volatility like we have seen in the past week or so
• A Corporate Update Provides Clarity On What Could Be A Very Bright Future
• An Explosive Chart History Is Must-See Stuff (Major Short Term Mover Capability)
• A Huge 2023 Acquisition Further Establishes A Strong Presence In the MASSIVE Indian Market

LYTUS Technologies’ Company Vision

Transformation is key for making a better world and LYTUS makes this easier. At LYTUS we believe advancing technology comes with many spheres to improve the human experience. LYTUS’ goal is to super-serve customers by combining multiple service domains into a unified LYTUS lifestyle platform that gives customers entertainment, information, healthcare, and fi-nan-cial freedom.

LYTUS is a rapidly growing Platform IT services company. It currently has over 4 million active viewers and users in India with an accelerated user growth model by combining its growing online content and streaming service.

LYTUS focuses on advancing technologies in media, entertainment, healthcare, and fi-nan-cial services to improve customer experiences worldwide. With an established and expanding customer base in India, LYTUS is soon launching platform services in the U.S. and Middle East.

Why LYTUS Technologies?

Established customer base in two of the biggest high growth markets: the US and India.

Strong business model, repeatable and scalable across geographies.

Unique customer conversion strategy, subscriber growth and additional value-added services.

Present CAGR (streaming business) greater than 5%, expected CAGR (streaming and telemedicine business) approximately at 18%.

Company Overview

Subscriber-based cable streaming company with stable growth and strong tech team. Providing a comprehensive and diversified range of bundled offerings across healthcare, fintech and streaming segments.

Fintech platform services for subscriber-based technology entities for our sub.scribers and advertising entities in India.

Developing post-production technology labs with patented technology workflow for 4 K & 8 K resolution, servicing all major.

Hollywood studios; along with a high-end physical production studio for content creation in Hollywood.

Transforming a nationally distributed American TV Network and OTT, in the U.S.

Strong healthcare technology business with device integration for remote patient care and partnerships with existing hospital networks.

Strong revenue base through a sub.scription model and advertising income in India. Developing technology platform services and generating revenues in the United States and in India.

Company Highlights

Active: Streaming Services

Subscription: Lytus provides its retail and commercial customers with monthly subscription-based linear video services and Internet services.

Customers: Strong nationwide customer base in Nationwide in India.

Programming: 450+ Linear SD/HD channels through various content providers such as Star TV (Disney), Zee TV, Sony, Times Broadcasting, Discovery and others.

Exclusive Content: Lytus creating original exclusive content in Hollywood & Bollywood Studios.

Add-ons: IPTV & Broadband Value added lifestyle and financial services to platform customers.

LYTUS Technologies Projections (5 Years) In USD Mn

Planned Company Rollouts

Smart OTT – SVOD with Hyper-Personalization (Launch 4th Quarter 2024)

International movies, series and award-winning documentaries from around the world that are critically acclaimed and hard to find.

Exclusive streaming channels and programs with hyper-personalization, that curate playlists for subscribers to achieve their health goals.

Healthcare Technology Services

Focus: To provide telemedicine solutions for the growing medical needs in India, starting with the North-Eastern regions.

U.S. Operations: Lytus through the U.S. research unit offers telemedicine services support to Indian patients.

India Operations: Ready to launch telemedicine in India using an advanced technology platform in conjunction with Lytus’s pioneering local health center network and mobile health camps.

Services: Offering basic healthcare monitoring with the help of smart devices, software systems and diagnostic / examination support services.

Value Proposition: Our existing customer base and access to a significant connected infrastructure enables us to provide telemedicine services for the health needs for two million families.

Fintech Services

• Payment Gateway to existing 4 million + active users.
• E Wallet for seamless transactions.
• Banking services in your hand.
• Wealth management and st-ock market integration.
• Insurance plans with best option services.

LYTUS TECHNOLOGIES MAKES SIGNIFICANT PROGRESS ON BROADBAND AND IPTV SERVICES

Mumbai | New York, July 20, 2023 (GLOBE NEWSWIRE) — Nasdaq-listed Lytus Technologies Holdings PTV. Ltd. (the “Company”) (NASDAQ:LYT), a leading global technology-driven services company, has recently shared updates on progress on its IPTV and Broadband Services.

The Company announced the launch of its IPTV and Broadband services to its customers in India. It has installed a dedicated IPTV headend which is equipped with the latest technology to deliver quality content to its subscribers. The Company has also secured IPTV content from broadcasters.

Through its acquisition of Sri Sai, the company is one of the largest cable streaming players in the region. The Company plans to roll-out its services to its approx. 4 million subscribers through the network of more than 5,000 local cable operators.

LYTUS TECHNOLOGIES ENTERS FINTECH SPACE WITH THE LAUNCH OF A NEW PAYMENT GATEWAY IN INDIA

~Will invest 50 million dollars to expand their fintech service in India over the next 5 years~

Mumbai | New York, July 24, 2023 (GLOBE NEWSWIRE) — Nasdaq-listed Lytus Technologies Holdings PTV. Ltd. (the “Company”) (NASDAQ: LYT), a leading global technology-driven services company, has announced the launch of its payments gateway for Indian consumers. This marks the entry of Lytus Technologies into the Indian fintech market through the introduction of its payments gateway offerings to businesses in the Indian cable and broadband sector.

Lytus Technologies entered the Indian market with its Telecast & Multicast and broadband services and recently acquired a 51% stake in Sri Sai Cable and Broadband Private Limited in Telangana, India. With the strategic aim of expanding its footprint in India by offering diverse services to Indian consumers, the launch of the payment gateway will provide an additional boost to the company in the market. Initially, Lytus consumers using IPTV and broadband services will enjoy the convenience of the new payment gateway, facilitating their transactions.

The Indian Fintech market is currently the second largest market in the world by deal volume. It is expected to grow to USD 2.1 Tn by 2030 at a CAGR of more than 18%. With a fintech adoption rate of 87% against the global average of 64%, India is one of the fastest growing fintech markets in the world. The Indian fintech industry has experienced exponential growth over the past few years, supported by the Indian government’s initiatives to promote the digitization of financial systems and a cashless economy. This effort has successfully shifted consumer focus toward digital alternatives for financial transactions and services. The rise of digital commerce, along with innovations in payment technology using AI, blockchain, the Internet of Things (IoT), and the introduction of mobile point-of-sale (POS) devices, has significantly contributed to the tremendous success of the fintech industry in India.

According to Shreyas Shah, CFO of Lytus Technologies, “Lytus’s unique business model is particularly suited to expand its fintech services offering to its nationwide base of nearly 4 million users. The company intends to invest 50 million dollars to expand its fintech business in India over the next five years. While the initial rollout is focused on a B2B model, it plans to extend services to its individual subscribers within the next 12 months. Lytus’ fintech products will be initially available to customers in metro cities, and the company will also focus on offering its fintech services to businesses and individuals in rural parts of India to bridge the gap that currently exists in the traditional banking sector.”

Huzaefa Lokhandwala, CEO of Lytus Fintech, anticipates that, “Over the course of the next several months, Lytus intends to expand the scope of its fintech services to include AI-driven next-generation payment platforms, P2P lending, blockchain, insurtech, digital shareholder services, cross-border payments, among other services. Lytus also plans to offer its subscribers e-wallet and credit card services using AI-based technology for personalized financial insights. Users will be able to set spending goals based on their priorities, earn rewards, and leverage the features to develop good financial habits and achieve their long-term goals.”

Lytus Technologies’ entry into the Indian fintech market with its innovative payments gateway marks an exciting milestone in the company’s growth journey. With its strategic expansion plans, including the intention to offer an array of AI-driven financial services and personalized solutions, Lytus aims to cater to the evolving needs of Indian consumers and businesses alike. As India’s fintech landscape continues to thrive, Lytus Technologies’ commitment to bridging the digital divide between urban and rural areas and providing cutting-edge fintech solutions is set to contribute significantly to the country’s vibrant financial ecosystem.

GLOBAL FIRM LYTUS TECHNOLOGIES ACQUIRES MAJORITY STAKE IN SRI SAI CABLE AND BROADBAND PRIVATE LIMITED FOR ITS STRATEGIC EXPANSION PLANS

~Existing customers base of 1 million + subscribers and 4 million + active users to benefit from emerging technology solutions for tomorrow, to get access to a host of value-added services with the click of a button~

Hyderabad, 16th May, 2023: Nasdaq-listed Lytus Technologies Holdings PTV Ltd., a leading global technology-driven services company, has recently announced its acquisition of Sri Sai Cable and Broadband Private Ltd., a leading regional Multi Service Operator (MSO) based in Telangana, India. This strategic move signifies Lytus Technologies’ commitment to establishing a strong presence in the Indian market. By acquiring a 51% stake in Sri Sai Cable and Broadband Private Limited, which boasts a subscriber base of over 1 million, Lytus Technologies aims to expand its footprint in India in line with its strategic growth plans.

Lytus Technologies, established in 2017 by a visionary team of technology entrepreneurs, is a publicly listed company on the Nasdaq Capital Market under the ticker symbol “LYT”. The acquisition of Sri Sai Cable is expected to significantly bolster Lytus Technologies’ reach in the Telangana region with a customer base extending into Andhra Pradesh, Maharashtra, and Kerala. As the leading independent Multi Service Operators (MSOs) in Telangana, Sri Sai Cable will enable Lytus Technologies to enhance its service offerings and expand its presence in the region. With more than 40% market share in their dedicated network area, Sri Sai Cable and Broadband Private Limited boasts a flourishing network of over 6,500 local cable operators. As a result of Lytus Technologies’ acquisition of a majority stake in the company, current consumers of Sri Sai Cable will benefit from enhanced technology, resulting in a better viewing experience.

Specializing in Telecast & Multicast services, Lytus Technologies offers monthly subscription-based linear television and Internet services to both retail and business clients. The company’s robust network infrastructure spans over a 5,000-kilometer deployed network, providing fiber and broadband services. Since its inception, Lytus Technologies has expanded its presence in India through its Telecast & Multicast (IPTV) services. The recent acquisition of Sri Sai Cable further strengthens Lytus Technologies’ presence in India, allowing the company to cater to the Indian diaspora with captivating content and value-added services. This strategic acquisition represents a significant step forward in Lytus Technologies’ expansion plans, positioning the company as a key player in the Indian market and reinforcing its dedication to delivering innovative services to customers nationwide.

Commenting on the acquisition of Sri Sai Cable and Broadband Private Limited, Dharmesh Pandya, CEO, Lytus Technologies said, “Since our inception, Lytus Technologies has been committed to providing diverse entertainment options to the Indian audience. The recent acquisition of Sri Sai Cable and Broadband Private Limited enables us to expand our reach by offering cable and internet services not only to consumers in Telangana but also to their extended subscriber base in Andhra Pradesh, Maharashtra and Kerala. Through collaborative efforts, we will develop new technologies aimed at better serving our customer base. India is our primary market for IPTV services, and this year, we are launching IPTV and Internet services, positioning ourselves for revenue growth. Additionally, we are in the process of revising rates in accordance with the New Tariff Order, further enhancing our offerings and providing value to our customers.”’

Srinivas Palle, CEO, Sri Sai Cable and Broadband Private Limited said, “Indian customers are now evolving and are keen to receive high-quality services. Being one of Telangana’s major Multi Service Operators, we strive to cater to ever-changing consumer behavior. With our partnership with Lytus Technologies, we will continue to focus on client needs and expand our footprint in larger parts of India. We intend to maintain and improve our technology in order to gain a larger market share in our network locations.”

Lytus Technologies has established a consumer base across major cities in India, including Mumbai, Hyderabad, Kolkata, New Delhi, and Allahabad. The company offers a comprehensive range of services, providing access to over 450 linear SD/HD channels from various content sources such as Star TV (Disney), Zee TV, Sony, Times Broadcasting, and Discovery. The company is actively engaged in strategic alliances with numerous major global corporations, a move aimed at expanding its reach and presence in the market. These alliances position Lytus Technologies for further growth in the near future.

About Sri Sai Cable and Broadband Private Limited:

Sri Sai Cable & Broadband Pvt. Ltd (SSCBPL) is a leading regional Multi Service Operator (MSO) in Telangana, offering high-quality cable television and broadband services. With a rich history in the industry, Sri Sai Cable & Broadband Pvt. Ltd’s operations began in 1995 as Sri Sai Communication, providing analogue control room and cable TV services. In 2011, the cable operator embraced the digital era and started offering the best-in-class Digital Cable Television experience to viewers across Telangana, Andhra Pradesh, and other states of India. The vision of SSCBPL, is to create a robust, futuristic, and technologically advanced network that spans the entire state of Telangana and Andhra Pradesh. As the top MSO in Telangana, the company holds a dominant market share of over 40% of cable television subscribers. The digital cable television services of Sri Sai Cable & Broadband Pvt. Ltd have reached nearly all towns in Telangana and some parts of Andhra Pradesh, catering to approximately 0.9 million active digital cable subscribers.

NEWS

PUBLISHED

AUG 23, 2023

LYTUS TECHNOLOGIES RECEIVES NASDAQ NOTIFICATION OF NONCOMPLIANCE WITH AUDIT COMMITTEE REQUIREMENTS

PUBLISHED

AUG 22, 2023

LYTUS TECHNOLOGIES RECEIVES NASDAQ NOTIFICATION OF NONCOMPLIANCE WITH LISTING RULE 5250(C)(1)

PUBLISHED

JUL 24, 2023

LYTUS TECHNOLOGIES ENTERS FINTECH SPACE WITH THE LAUNCH OF A NEW PAYMENT GATEWAY IN INDIA

PUBLISHED

JUL 20, 2023

LYTUS TECHNOLOGIES MAKES SIGNIFICANT PROGRESS ON BROADBAND AND IPTV SERVICES

PUBLISHED

MAR 30, 2023

LYTUS TECHNOLOGIES RECEIVES NOTICE FROM NASDAQ

PUBLISHED

NOV 16, 2022

LYTUS TECHNOLOGIES HOLDING PTV. LTD. ANNOUNCES SUCCESSFUL CLOSING OF $3.3 MILLION FUNDING ROUND

PUBLISHED

SEP 30, 2022

LYTUS TECHNOLOGIES RECEIVES LETTERS FROM NASDAQ

PUBLISHED

JUN 17, 2022

LYTUS ANNOUNCES THE CLOSING OF INITIAL PUBLIC OFFERING

MANAGEMENT

DHARMESH PANDYA

GLOBAL CEO AND MANAGING DIRECTOR

Dharmesh Pandya, CEO of Lytus Technologies is a Technology, Tax and Corporate lawyer with over 25 years’ experience. A Graduate of Harvard Law School, he started his career with Big Four accounting firms in New York and helped build their International and Emerging Market Practices.

SHREYAS SHAH

GLOBAL CFO AND EXECUTIVE DIRECTOR

Shreyas Shah is a Chartered Accountant from India and LLM from the Netherlands (2011-12) with over 15 years experience. His expertise includes, inter-alia, to develop and implement an innovative, growth focused commercial strategy, focusing primarily on new product areas and emerging markets, while analysing, managing and mitigating potential legal, tax and financial risks.

RAJEEV KHEROR

INDEPENDENT DIRECTOR

Rajeev Kheror is a Los Angeles based producer, director and writer. He has produced and directed many award-winning films and series with more than 2000 hours of scripted, unscripted series and TV specials. He is a member of the Television Academy of Arts & Sciences, a gold medalist from Asian Academy of Film & Television and a Corporate Leader from Harvard Business School.

ROBERT DAMANTE

INDEPENDENT DIRECTOR

Mr. Damante is an experienced financial professional. He has been the Chief Financial Officer of two different Life Insurance Companies, and a senior executive in four others over the past 30 years. Recently retired, his most recent position was as EVP and CFO of Prosperity Life Group in New York. In that position he managed all financial activities of this multi-billion life insurance company.

SINCERELY,

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THIS WEBSITE/NEWSLETTER IS OWNED SUBSIDIARY BY DEDICATED INVESTORS, LLC.

OUR REPORTS/RELEASES ARE A COMMERCIAL ADVERTISEMENT AND ARE FOR GENERAL INFORMATION PURPOSES ONLY. WE ARE ENGAGED IN THE BUSINESS OF MARKETING AND ADVERTISING COMPANIES FOR MONETARY COMPENSATION. WE HAVE BEEN COMPENSATED A FEE OF FIFTEEN THOUSAND USD BY LFG EQUITIES CORP FOR A ONE DAY LYT AWARENESS CAMPAIGN. NEVER INVEST IN ANY STOCK FEATURED ON OUR SITE OR EMAILS UNLESS YOU CAN AFFORD TO LOSE YOUR ENTIRE INVESTMENT. THE DISCLAIMER IS TO BE READ AND FULLY UNDERSTOOD BEFORE USING OUR SERVICES, JOINING OUR SITE OR OUR EMAIL/BLOG LIST AS WELL AS ANY SOCIAL NETWORKING PLATFORMS WE MAY USE.PLEASE NOTE WELL: DEDICATED INVESTORS LLC AND ITS EMPLOYEES ARE NOT A REGISTERED INVESTMENT ADVISOR, BROKER DEALER OR A MEMBER OF ANY ASSOCIATION FOR OTHER RESEARCH PROVIDERS IN ANY JURISDICTION WHATSOEVER.RELEASE OF LIABILITY: THROUGH USE OF THIS WEBSITE VIEWING OR USING YOU AGREE TO HOLD DEDICATED INVESTORS LLC, ITS OPERATORS OWNERS AND EMPLOYEES HARMLESS AND TO COMPLETELY RELEASE THEM FROM ANY AND ALL LIABILITY DUE TO ANY AND ALL LOSS (MONETARY OR OTHERWISE), DAMAGE (MONETARY OR OTHERWISE), OR INJURY (MONETARY OR OTHERWISE) THAT YOU MAY INCUR. THE INFORMATION CONTAINED HEREIN IS BASED ON SOURCES WHICH WE BELIEVE TO BE RELIABLE BUT IS NOT GUARANTEED BY US AS BEING ACCURATE AND DOES NOT PURPORT TO BE A COMPLETE STATEMENT OR SUMMARY OF THE AVAILABLE DATA. 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OUR NEW PROFILE IS:   (NASDAQ: HRYU)

HRYU HAS CLOSED GREEN FOR 7 CONSECUTIVE SESSIONS NOW

ALL-IN-ONE SOCIAL EXPERIENCE PLATFORM CONNECTING K-CULTURE FANS AROUND THE WORLD

FANTOO SURPASSED 26.6 MILLION REGISTERED USERS GLOBALLY AND ~1.5 MILLION ACTIVE MONTHLY USERS AS OF MARCH 2023

USER ACQUISITION COST OF $0.038

VIEW THE INVESTOR PRESENTATION HERE

_______________________________

Hello Everyone,

We have another brand new company that we want you to research immediately for tomorrow’s session.  This one just IPO’d a few weeks back and after it had some turbulence initially, we are seeing this one turn around and close green 7 consecutive sessions in a row.

Pull up HRYU right away and start your research.

Hanryu Holdings is a media tech holding company incorporated in the U.S. with operations through its subsidiaries in South Korea. The Company has created FANTOO to provide distinctive service offerings, technology, applications and websites, through a multi-media global platform for our users to interact with other like-minded users, and share their appreciation as fans of various types of entertainment and cultures, create their own content, enjoy other user’s content, engage in e-commerce, and experience a community we believe is unlike any other.

FANTOO’s current users are enthusiasts of South Korean culture (“K-Culture”), also known as the “Korean Wave,” or “Hanryu”. The growing popularity of the Korean Wave has historically been driven by social networking services and online video sharing platforms. Through these channels, the dispersion and export of South Korean arts, music and entertainment has grown rapidly from a regional influence into a global appreciation of K-Culture. The expansion of the Korean Wave into a global phenomenon provides a significant opportunity to unite fans across the globe within the FANTOO platform.

FANTOO leverages the growing groups of fans with similar interests, known as “fandoms,” in order to tap into the “Fandom Economy” and monetize the growing fandom community. Through fandoms, fans have expanded the scope of their spending in a variety of ways, including paying for advertisements, production of products that promote or express their adulation for their favorite entertainers, and purchasing merchandise, as well as supporting the activities related to their interests by enthusiastically promoting them online through social media. With the rise of social media platforms, fans are no longer passive consumers of content, but are actively sharing ideas and acting as producers and content creators. Fans’ connectivity to fandoms is extremely high due to the ease of access allowed by mobile devices and applications. FANTOO allows fans to be proactive in their fandoms, and rewards users for their activity.

INVESTMENT HIGHLIGHTS

• FANTOO platform targeting $124B K-Culture purchasing power.
• Over 26.6 million users as of March 2023, 24 months after the app launch.
• Unique platform attracting a global audience of content creators and K-Culture fans.
• Fastest growing social media app for K-Culture fans.
• Multiple revenue opportunities now ready to turn on.

HANRYU HOLDINGS LAUNCHES FANTOO HOUSE, A PROFESSIONAL STUDIO RENTAL SERVICE FOR DIVERSE CREATIVE ACTIVITIES

August 22, 2023 9:00 am EDTDownload as PDF

FANTOO House will open on the 4th Floor of Seoul Marina in Yeouido, the Heart of Seoul as the Landmark of Hallyu Culture Content

SEOUL, REPUBLIC OF SOUTH KOREA / ACCESSWIRE / August 22, 2023 / Hanryu Holdings, Inc. (NASDAQ:HRYU) (the “Company” or “Hanryu”), a media-tech company and creator of FANTOO, an all-in-one social media experience connecting k-culture fans globally, today announced the launch of FANTOO House, a professional studio rental service for a diverse range of creative activities.

FANTOO House will open on the fourth floor of Seoul Marina in Yeouido, as a landmark of Hanryu culture content, providing a versatile event hall with a range of multipurpose rooms from creative spaces to live concerts.

FANTOO House will provide sound and lighting systems for hosting fan meetings, content shoots, seminars, brand launches, showcases, and banquets. It will include a rentable recording studio with Han River view, soundproofing, and cutting-edge equipment for recording, music production, cover videos, visual radio, and diverse content creation.

Hanryu Holdings aims to foster creativity and the discovery of promising new artists with FANTOO House and by activating the development of more user-generated content on the FANTOO App. Users of the FANTOO App can book and utilize rental spaces such as recording studios, cooking studios, and performance venues, as well as engage in various creative activities to produce content.

Also, Hanryu Holdings is producing their show contents at FANTOO House, and Hanryu Holdings can create better-quality contents for FANTOO Apps.

In addition, the Company expects FANTOO House to provide revenue generation with rental fees received from artists and companies renting the space, as well as the opportunity to leverage quality content generated with celebrities and partners at FANTOO House.

“FANTOO House is creating a landmark for K-pop creators and FANTOO users, opening in the heart of Seoul, as the new center of the Hanryu culture,” Chief Executive Officer of Hanryu Holdings, Kang Chang Hyeok, commented. “Hanryu also aims to promote content diversity and engagement within the K-pop community through the space and IP sharing that FANTOO House, in combination with the FANTOO App, will facilitate. In addition, we expect FANTOO House to provide the opportunity for revenue growth through rental fees received and better-quality content production, and we plan on expanding the business scope of the facility in the future.”

HANRYU HOLDINGS ANNOUNCES STRATEGIC PARTNERSHIP WITH POPULAR WOMEN’S CLOTHING LINE, PAPAYA, TO SELL FANTOO-BRANDED MERCHANDISE IN THE U.S.

September 11, 2023 9:00 am EDT

SEOUL, REPUBLIC OF SOUTH KOREA / ACCESSWIRE / September 11, 2023 / Hanryu Holdings, Inc. (NASDAQ:HRYU) (the “Company” or “Hanryu”), a media-tech company and creator of FANTOO, an all-in-one social media experience connecting k-culture fans globally, today announced the signing of a strategic Memorandum of Understanding (‘MOU’) partnership agreement with Ameridge Corp. (KOSDAQ: 900100), owner of the popular women’s clothing line, Papaya, to distribute its FANTOO-branded merchandise throughout at least 45 Papaya stores in the United States.

This strategic partnership is mutually beneficial and synergistic for Hanryu’s FANTOO application and Papaya. Papaya’s main customer demographic are women, ages 15 to 29, and approximately 81% of FANTOO’s over 26 million users are men and women ages 20 to 39. By supplying Papaya with the FANTOO-branded clothing to its loyal customers, Papaya will receive new merchandise SKUs for distribution through their brick and mortar network and FANTOO will be able to market directly to their target audience in the U.S., while also generating revenue.

“Our k-culture application, FANTOO, has quickly gained popularity globally among women under 40 years old. Our partnership with popular brand, Papaya, provides us with an opportunity to market directly to our fans in the U.S., while also presenting yet another revenue stream for the Company. We expect to launch our FANTOO-branded clothing line through Papaya this year and begin generating revenue. Our internal projections are that this agreement alone could generate over $10 million in revenue in 2024.”

NEWS

Sep 11, 2023 9:00 am EDT

HANRYU HOLDINGS ANNOUNCES STRATEGIC PARTNERSHIP WITH POPULAR WOMEN’S CLOTHING LINE, PAPAYA, TO SELL FANTOO-BRANDED MERCHANDISE IN THE U.S.

Sep 05, 2023 9:00 am EDT

HANRYU HOLDINGS ANNOUNCES ENHANCED CHAT FUNCTIONALITY FOR FANTOO, SUPPORTING GLOBAL FANDOM AND GROWING USER BASE

Aug 28, 2023 9:00 am EDT

HANRYU HOLDINGS LAUNCHES ‘I LOVE HANRYU’ EVENT WITH ASIA MODEL FESTIVAL

Aug 22, 2023 9:00 am EDT

HANRYU HOLDINGS LAUNCHES FANTOO HOUSE, A PROFESSIONAL STUDIO RENTAL SERVICE FOR DIVERSE CREATIVE ACTIVITIES

Aug 16, 2023 9:00 am EDT

HANRYU HOLDINGS’ APPLICATION, FANTOO, EXCLUSIVELY MARKETS AND HOSTS USER VOTING FOR HISTORICAL ASIA MODEL FESTIVAL

Aug 14, 2023 9:00 am EDT

HANRYU HOLDINGS PARTNERS WITH SALTLUX FOR DEVELOPMENT OF ARTIFICIAL INTELLIGENCE (AI) POWERED CONVERSATIONAL VIRTUAL ASSISTANT ON POPULAR K-CULTURE FANDOM APPLICATION, FANTOO

Aug 09, 2023 9:00 am EDT

HANRYU HOLDINGS LAUNCHES VERSION 2.0 OF POPULAR K-CULTURE FANDOM APPLICATION, FANTOO

Aug 03, 2023 10:45 am EDT

HANRYU HOLDINGS, INC. ANNOUNCES CLOSING OF $8.8 MILLION INITIAL PUBLIC OFFERING

Jul 31, 2023 7:05 pm EDT

HANRYU HOLDINGS, INC. ANNOUNCES PRICING OF $8.8 MILLION INITIAL PUBLIC OFFERING

Mar 23, 2023 4:30 pm EDT

HANRYU HOLDINGS ANNOUNCES FILING OF REGISTRATION STATEMENT FOR PROPOSED INITIAL PUBLIC OFFERING

MANAGEMENT TEAM

CHANG-HYUK KANG

CEO / Director

Mr. Kang earned a master’s degree in tax and law from Korea University. Successfully led renowned Korean companies. Currently directing the company’s business strategy to create organic synergy among its diverse business areas while expanding value.

DAE-HWAN SON

COO

Mr. Son is an established expert in the IT and entertainment industry. Served as president of an IT KOSDAQ-listed company. Oversaw business and artist management at StarM Entertainment and Wellmade Yedang.

JU-HYON SHIN

CFO

Mr. Shin has over 25 years’ experience working as CFO for companies including public company with sales of $33 million. He is an expert in corporate finance, business strategic planning, performance management, and risk management.

DAVID GREGG

CCO

Mr. Gregg is a social enterprise strategist with experience in developing enterprise projects. He is also a seasoned marketing executive across all business sectors, including mid-market and enterprise entities. He previously co-founded SocialWise and served as CEO.

DONG-HOON PARK

CMO

Mr. Park served as CEO of a marketing agency and has effectively led new businesses and brands of established clients by building media plans and marketing strategies for various business areas.

TAE-HOON KIM

CTO

Mr. Kim has more than two decades’ experience in the IT and gaming industries, leading projects for the biggest IT companies including Naver and NHN. He served as COO and CEO for Webzen Inc. before he founded his own company Rulemakr in 2014 and has been serving as CEO.

SINCERELY,

DISCLAIMER

THIS WEBSITE/NEWSLETTER IS OWNED SUBSIDIARY BY DEDICATED INVESTORS, LLC.

OUR REPORTS/RELEASES ARE A COMMERCIAL ADVERTISEMENT AND ARE FOR GENERAL INFORMATION PURPOSES ONLY. WE ARE ENGAGED IN THE BUSINESS OF MARKETING AND ADVERTISING COMPANIES FOR MONETARY COMPENSATION. WE HAVE BEEN COMPENSATED A FEE OF TWELVE THOUSAND FIVE HUNDRED USD BY AMPLIFY IR INC FOR A ONE DAY HRYU AWARENESS CAMPAIGN. NEVER INVEST IN ANY STOCK FEATURED ON OUR SITE OR EMAILS UNLESS YOU CAN AFFORD TO LOSE YOUR ENTIRE INVESTMENT. THE DISCLAIMER IS TO BE READ AND FULLY UNDERSTOOD BEFORE USING OUR SERVICES, JOINING OUR SITE OR OUR EMAIL/BLOG LIST AS WELL AS ANY SOCIAL NETWORKING PLATFORMS WE MAY USE.PLEASE NOTE WELL: DEDICATED INVESTORS LLC AND ITS EMPLOYEES ARE NOT A REGISTERED INVESTMENT ADVISOR, BROKER DEALER OR A MEMBER OF ANY ASSOCIATION FOR OTHER RESEARCH PROVIDERS IN ANY JURISDICTION WHATSOEVER.RELEASE OF LIABILITY: THROUGH USE OF THIS WEBSITE VIEWING OR USING YOU AGREE TO HOLD DEDICATED INVESTORS LLC, ITS OPERATORS OWNERS AND EMPLOYEES HARMLESS AND TO COMPLETELY RELEASE THEM FROM ANY AND ALL LIABILITY DUE TO ANY AND ALL LOSS (MONETARY OR OTHERWISE), DAMAGE (MONETARY OR OTHERWISE), OR INJURY (MONETARY OR OTHERWISE) THAT YOU MAY INCUR. THE INFORMATION CONTAINED HEREIN IS BASED ON SOURCES WHICH WE BELIEVE TO BE RELIABLE BUT IS NOT GUARANTEED BY US AS BEING ACCURATE AND DOES NOT PURPORT TO BE A COMPLETE STATEMENT OR SUMMARY OF THE AVAILABLE DATA. DEDICATED INVESTORS LLC ENCOURAGES READERS AND INVESTORS TO SUPPLEMENT THE INFORMATION IN THESE REPORTS WITH INDEPENDENT RESEARCH AND OTHER PROFESSIONAL ADVICE. ALL INFORMATION ON FEATURED COMPANIES IS PROVIDED BY THE COMPANIES PROFILED, OR IS AVAILABLE FROM PUBLIC SOURCES AND DEDICATED INVESTORS LLC MAKES NO REPRESENTATIONS, WARRANTIES OR GUARANTEES AS TO THE ACCURACY OR COMPLETENESS OF THE DISCLOSURE BY THE PROFILED COMPANIES. NONE OF THE MATERIALS OR ADVERTISEMENTS HEREIN CONSTITUTE OFFERS OR SOLICITATIONS TO PURCHASE OR SELL SECURITIES OF THE COMPANIES PROFILED HEREIN AND ANY DECISION TO INVEST IN ANY SUCH COMPANY OR OTHER FINANCIAL DECISIONS SHOULD NOT BE MADE BASED UPON THE INFORMATION PROVIDED HEREIN. INSTEAD DEDICATED INVESTORS LLC STRONGLY URGES YOU CONDUCT A COMPLETE AND INDEPENDENT INVESTIGATION OF THE RESPECTIVE COMPANIES AND CONSIDERATION OF ALL PERTINENT RISKS. READERS ARE ADVISED TO REVIEW SEC PERIODIC REPORTS: FORMS 10-Q, 10K, FORM 8-K, INSIDER REPORTS, FORMS 3, 4, 5 SCHEDULE 13D.DEDICATED INVESTORS LLC IS COMPLIANT WITH THE CAN SPAM ACT OF 2003. DEDICATED INVESTORS LLC DOES NOT OFFER SUCH ADVICE OR ANALYSIS, AND DEDICATED INVESTORS LLC FURTHER URGES YOU TO CONSULT YOUR OWN INDEPENDENT TAX, BUSINESS, FINANCIAL AND INVESTMENT ADVISORS. INVESTING IN MICRO-CAP AND GROWTH SECURITIES IS HIGHLY SPECULATIVE AND CARRIES AND EXTREMELY HIGH DEGREE OF RISK. IT IS POSSIBLE THAT AN INVESTORS INVESTMENT MAY BE LOST OR IMPAIRED DUE TO THE SPECULATIVE NATURE OF THE COMPANIES PROFILED.THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995 PROVIDES INVESTORS A SAFE HARBOR IN REGARD TO FORWARD-LOOKING STATEMENTS. 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OUR NEW PROFILE IS:  

NASDAQ: CTXR

“MINO-WRAP” COULD REVOLUTIONIZE $400 MILLION POST-MASTECTOMY INFECTION PREVENTION MARKET

$CASH AND CASH EQUIVALENTS OF $33.3 MILLION AS OF JUNE 30, 2023

CTXR) COMPLETED PIVOTAL PHASE 3 TRIAL OF I/ONTAK (E7777) AND SUBMITTED BIOLOGICS LICENSE APPLICATION (BLA) TO THE U.S. FOOD AND DRUG ADMINISTRATION (FDA)

CITIUS PHARMACEUTICALS TO BE ADDED TO RUSSELL 3000® AND RUSSELL 2000® INDEXES

CITIUS PHARMACEUTICALS REACHES 92 EVENT MILESTONE IN MINO-LOK® PHASE 3 TRIAL

DOWNLOAD THE INVESTOR PRESENTATION HERE

DOWNLOADS THE FACT SHEET HERE 

_______________________________

Hello Everyone,

We have a past winner back on our radar to research for Friday’s session.

CTXR is a company that we have profiled several times over the past few years and we have seen some tremendous swings to the upside in this one since we have been following it.

It is sitting right below that all important dollar resistance point with several catalysts in play right now that you should research regarding this extremely well funded company.

ANALYST TARGET:

H.C. Wainwright analyst Vernon Bernardino’s $4.00 target could mean a potential upside of over 342% for Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) after bouncing off a low of $.9044 on 9/6/23, according to Barchart.com’s price history. )^(33)(52)

POTENTIAL FDA APPROVAL FOR LYMPHIR™ (DENILEUKIN DIFTITOX):

Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) has received a Complete Response Letter from the FDA, highlighting the need for enhanced product testing and additional controls. The absence of concerns regarding clinical efficacy and safety data is a significant positive indicator. ⁽⁵⁵⁾

PHASE 3 TRIAL:

Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) completed Pivotal Phase 3 trial of I/ONTAK (E7777) and submitted biologics license application (BLA) to the U.S. Food and Drug Administration (FDA).⁽³⁵⁾

BIOTECH CLUSTER WITH 70 NEW FDA APPROVALS:

The company is headquartered in a hotbed and breeding ground for successful Biotechs, which were responsible for a staggering 70 new FDA dr-ug approvals between 2020 and 2021.⁽⁴⁰⁾

ACCELERATED ADVANCEMENT:

Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) expanded and accelerated its Phase 3 Mino-Lok trial to additional sites outside the United States. If approved, Mino-Lok would be the first-and-only antibiotic lock solution FDA-approved to salvage infected central venous catheters (CVCs) causing catheter-related bloodstream infections (CRBSIs).⁽³⁵⁾

MAJOR INDEX INCLUSION:

Citius Pharmaceuticals, Inc. (Nasdaq: CTXR)’s addition to the Russell 3000® and Russell 2000® Indexes not only raises its profile in the market but also reflects the company’s growth potential and commitment to advancing healthcare solutions. ⁽⁶⁰⁾

Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) Gets $4 Target From Director of Equity Research at H.C. Wainwright, Vernon Bernardino ^(52)(53)

Image Source (52)

In the world of healthcare equity research, few individuals command the level of respect and admiration as Mr. Vernon Bernardino. As the Managing Director of Equity Research at H.C. Wainwright, Mr. Bernardino has spent over a decade navigating the intricate landscape of the healthcare sector, leaving a trail of impactful insights and accomplishments in his wake.

A Wealth of Expertise in Healthcare
Vernon Bernardino’s research at H.C. Wainwright focuses on the vast and ever-evolving healthcare sector. His specific areas of therapeutic interest encompass a wide array of medical fields, including vascular diseases, gastrointestinal and autoimmune diseases, infectious diseases, metabolic conditions, and rare diseases. This broad spectrum of expertise showcases his dedication to understanding the diverse and complex facets of the healthcare industry.

A Decade-Plus Journey in Healthcare
With over a decade of experience in the healthcare sector, Vernon Bernardino has honed his skills in both sell-side and buy-side equity research. His journey through the industry’s ranks has seen him contribute his insights to several prestigious Wall Street firms.
Prior to his tenure at H.C. Wainwright, Mr. Bernardino made significant contributions as a healthcare equity research analyst at multiple renowned firms, including Seaport Global Securities, B. Riley FBR, Rodman & Renshaw LLC, UBS Securities, and Nicholas Applegate Capital Management (now part of Allianz SE). His work has not gone unnoticed; in 2017, he was recognized by TipRanks as one of the Top 150 Wall Street analysts, a testament to his exceptional analytical prowess.

A Trailblazer in Cardiovascular Research
Before his illustrious career on Wall Street, Vernon Bernardino made waves as a scientist in the biotechnology and pharmaceutical industry. His research in cardiovascular diseases proved to be groundbreaking, leading to the discovery and development of Zetia, a cholesterol-lowering drug with annual sales exceeding $2 billion. This remarkable achievement underscores his profound impact on the advancement of healthcare solutions that benefit millions of patients worldwide.

A Visionary Entrepreneur
Beyond his roles in research and analysis, Mr. Bernardino’s entrepreneurial spirit shines through. He founded Oceros Advisors LP, a strategic healthcare advisory group. This venture allows him to leverage his wealth of knowledge and insights to provide valuable guidance and strategies in the ever-evolving healthcare landscape.

Educational Excellence
Vernon Bernardino’s academic background is as impressive as his professional journey. He holds an MBA in Finance from the University of San Diego, reflecting his commitment to a deep understanding of financial aspects within the healthcare industry. Additionally, he earned a BA from Rutgers University, emphasizing his well-rounded education that encompasses various facets of the healthcare sector.

A Positive Outlook on Citius Pharmaceuticals, Inc. (Nasdaq: CTXR)
Vernon Bernardino’s extensive experience and keen insights extend to his assessment of Citius Pharmaceuticals, Inc. (Nasdaq: CTXR). With a thorough analysis of the company’s prospects, he has set a $4.00 target on Citius Pharmaceuticals, Inc. (Nasdaq: CTXR). This target is a testament to his confidence in the company’s future in the healthcare sector. (52)(53)

Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) Has Built a Diversified Pipeline of Therapeutics with a Multi-Billion-Dollar Total Addressable Market.⁽⁴³⁾

Non-Hodgkin’s Lymphoma is one of the deadliest forms of cancer.

Targeting your body’s germ-fighting immune system, it invades your body’s lymph nodes. Left unchecked, it can kill more than 1-in-3 of those diagnosed, with over a half-million new cases each year.

But one company could be set to change all that…

Flying well under the radar, Citius Pharmaceuticals (NSDQ: CTXR) has quietly acquired the rights to the experimental compound “E-7777,” ⁽²⁷⁾ a direct improvement to a previously FDA-approved medication that directly attacks infected cancer cells inside the human body.

And this new cancer-fighting remedy could be mere months away from its own approval. If and when it hits the market, this new treatment could provide a whole new proven alternative to the harsh side effects of chemotherapy or aggressive radiation treatment.

Directly targeting and attacking infected cells, E-7777 could transform the $5.4 Billion market for Non-Hodgkin’s Lymphoma treatment.

The best part of this whole story? This is just one of several potentially game-changing new therapies in the company’s pipeline …

CITIUS PHARMACEUTICALS, INC. IS A BIOPHARMA POWERHOUSE HIDING IN PLAIN SIGHT

Citius Pharmaceuticals United States NASDAQ: (CTXR) is what’s called a “late-stage biopharmaceutical” company, where a highly-experienced management team purchases rights to the most promising new therapies and then either brings them to market or licenses rights to bigger pharma companies like Pfizer or Johnson & Johnson.

It should go without saying that “late-stage” development is the most difficult, most expensive part of the process for any new kind of treatment. Because even after years of investment, research and development, some 2 out of 5 drugs still fail to secure final FDA approval.⁽³⁰⁾

But with a “Dream Team” of top industry insiders, Citius is turning the odds in their favor—with two treatments now in Phase 3, and both looking like they will pass.

In addition to E-7777, it’s currently advancing three proprietary product candidates in total:⁽¹²⁾

• Mino-Lok has advanced to Phase 3 clinical studies.
• CITI-101 (Mino-Wrap) is a malleable, bio-absorbable film impregnated with minocycline and rifampin. It is designed to reduce infections associated with the use of breast tissue expanders (TE) used in breast reconstruction surgeries following mastectomies.
• CITI-002 is being developed to provide anti-inflammatory and anesthetic relief to persons suffering from hemorrhoids.

We’re going to focus primarily on Mino-Lok here, since it’s Citius Pharmaceuticals’ most promising (and most immediate) potential revenue source …

MINO-LOK’S PHASE 3 CLEARANCE COULD BE THE KEY TO COMMANDING A $1.5 BILLION ² MARKET:

Mino-Lok is an antibiotic designed to treat patients with catheter-related bloodstream infections (CRBSIs). At present, these infections are treated by removing the catheter and prescribing antibiotics.

This is a costly medical process with potential complications. In fact, studies show that removal and reinsertion of CVCs have a 15% to 20% complication rate, including pneumothorax, misplacement, and arterial puncture. ⁽⁴⁾

Mino-Lok allows doctors to treat the infection without needing to remove the catheter, avoiding both costs and complications.

North America is projected to account for a major share of the global catheter-related bloodstream infections market during the forecast period due to well-established health care infrastructure. Europe is anticipated to be the second largest market from 2020 to 2030. ⁽³¹⁾

This market has very little, if any, competition

But here’s the biggest catalyst for Citrus, the global catheter-related bloodstream infections market is highly consolidated due to the presence of a small number of key players – which means at this time there is very little in the way of competition. ⁽³¹⁾

Currently, in Phase 3 pivotal trials, it could be approved in a matter of months … giving Citrus a massive leg up on any competition.

According to CEO Myron Holubiak: ⁽¹⁴⁾

“Data from the Mino-Lok® (M-L) Phase 3 program was reviewed by our independent Data Monitoring Committee (DMC) for safety and efficacy and found to be progressing as planned with no recommended changes to trial design.”

MINO-LOK HAS REPORTEDLY PERFORMED WELL TO DATE: ⁽¹⁸⁾

• Mino-Lok is the first and only therapy under investigation to salvage infected CVCs. In a Phase 2b trial, the Mino-Lok product demonstrated a 100% efficacy rate in salvaging colonized CVCs.
• Mino-Lok had no significant adverse events compared to an 18% serious adverse event rate when infected CVCs were removed and replaced.
• FDA Fast Track with QIDP designation and patent protection until June 2024. Formulation patent protection until November 2036. Currently in a Phase 3 pivotal superiority trial. ⁽¹⁴⁾

MEANWHILE, CITIUS’ “MINO-WRAP” COULD REVOLUTIONIZE $400 MILLION
POST-MASTECTOMY INFECTION PREVENTION MARKET

Citius’ Mino-Wrap could help reduce post-operative infections associated with surgical implants. Its gel-containing film is used primarily to wrap the tissue expander used in breast reconstructive surgeries.

As also noted by CEO Holubiak: ⁽¹⁴⁾

“We believe that this serious condition impacts about 100,000 women in the U.S. and many more in the rest of the world. Mino-Wrap is a bio-absorbable, antimicrobial semi-solid film that is wrapped around a tissue expander and placed in the surgical pocket following a mastectomy to prevent post-surgical infections. Once implanted, Mino-Wrap slowly dissolves in situ for a specified period of time, providing extended protection against infection.”

PROGRAM HIGHLIGHTS ⁽¹⁹⁾

• Potential to be first and only FDA-approved product to prevent infections associated with post-mastectomy breast implants
• Currently in preclinical development
• Development in partnership with The University of Texas MD Anderson Cancer Center and support from medical thought leaders

OFFERING RELIEF IN AN $80 MILLION HEMORRHOIDS MARKET

Shockingly, there are no FDA-approved prescription products for hemorrhoids at the moment.⁽¹⁶⁾

However, that could soon change with Citius’ halobetasol and lidocaine formulations.

Hemorrhoids are an uncomfortable and often recurring condition. However, despite the numerous prescriptions and over the counter (OTC) products commonly used to treat hemorrhoids, none possess the necessary safety and efficacy data generated from rigorously conducted clinical trials.

Citius believes its halobetasol-lidocaine product could one day become that go-to treatment for physicians wanting to provide patients with a therapy demonstrating safety and efficacy.⁽¹⁶⁾

PROGRAM HIGHLIGHTS: ⁽²⁰⁾

• There are no FDA-approved prescription products on the market for hemorrhoids
• Citius’ halobetasol and lidocaine formulation could become the first FDA-approved prescription product to treat hemorrhoids in the United States
• According to IMS, over 25 million units of topical combination prescription products for hemorrhoids are sold in the US

CITIUS PHARMACEUTICALS COULD EVEN HELP TREAT ARDS, TOO

• There are about three million cases of Acute Respiratory Distress Syndrome (ARDS) globally, with approximately 200,000 instances just in the U.S.⁽¹⁷⁾
• The health crisis significantly added to the amount of ARDS cases, with death rates among patients on ventilators as high as 50%.⁽¹⁷⁾
• Worse, at the moment, there are no approved treatments for ARDS.⁽¹⁷⁾

According to Citius CEO Holubiak:

“Currently, there is no FDA-approved drug therapy for ARDS. We plan to submit an IND to the FDA and initiate our Phase 1 study by the end of the second quarter of 2022. Our first-in-human clinical trial is entitled “i-MSCs in Subjects with Acute Respiratory Distress Syndrome (ARDS) Due to [the health predicament]: i-MARCO.” Following the completion of a multi-center Phase 1 pilot study, we would expect to proceed on to a double-blinded, randomized Phase 2/3 trial to demonstrate the safety, efficacy, and multimodal healing capabilities of our i-MSCs in patients with moderate to severe ARDS due to [the health predicament].” ⁽¹⁴⁾

PROGRAM HIGHLIGHTS: ⁽²¹⁾

• Novel stem cell therapy for the treatment of acute inflammatory respiratory disorders including acute respiratory distress syndrome (ARDS)
• i-MSCs derived from induced pluripotent stem cell reprogrammed using proprietary mRNA process
• No FDA-approved treatment for ARDS exists today
• Preclinical activities are underway

$7.2 BILLION IN POTENTIAL MARKET DISRUPTION

As you’ve seen today, some of the treatments in Citius Pharmaceuticals’ portfolio go far beyond the definition of “Cutting Edge” …

Mino-Lock could potentially erase the need to operate on those suffering from Catheter-Related Bloodstream Infections (CRBIs), revolutionizing treatment of a $1.5 Billion medical problem overnight. E-7777 could offer a powerful new alternative to those suffering from Non-Hodgkin’s Lymphoma.

Combined with a full pipeline of other treatments, Citius Pharmaceuticals could be sitting on top of $5.5 Billion in cumulative pharmaceutical market disruption…

With a full year’s “cash runway” (through December 2023)(43)left to complete critical Research & Development, along with the outrageous profit potential if even one of these treatments makes it to market, Citius Pharmaceuticals (NSDQ:CTXR) is a company that should definitely be on your radar.

CITIUS PHARMACEUTICALS, INC. (NASDAQ: CTXR) IS HEADQUARTERED IN ONE OF THE COUNTRY’S HOTTEST BREEDING GROUNDS FOR FOR SUCCESSFUL BIOTECH’S

New Jersey’s biotechnology cluster has grown from a mere 30 companies in the early 1990s to approximately 3,200 establishments in the state today. 46 of those firms are responsible for a staggering 70 new FDA drug approvals between 2020 and 2021, according to the trade association BioNJ.⁽⁴⁰⁾

And several sources indicate that despite recent IPO and capital market challenges, the biotech cluster’s ascension continues.⁽⁴⁰⁾

Debbie Hart, president and CEO of BioNJ, says of the overall US/global biotech community: “The science is advancing by leaps and bounds, and it’s creating lots of opportunities, new companies, and new advances in therapies and treatments.”⁽⁴⁰⁾

“When you look at what happened during the global pandemic – how the industry can really save the world – [it’s] not an understatement. It just speaks to ability and the science.”⁽⁴⁰⁾

New Jersey’s specific biotech juggernaut partly stems from a constellation of cutting-edge advances in cell and gene therapy operating in tandem with a Garden State life sciences ecosystem replete with contract manufacturing and clinical research organizations, as well as specialized accountants, attorneys, and other professionals who serve the industry.⁽⁴⁰⁾

Such a network is particularly important for the biotechnology community given the challenges it faces.⁽⁴⁰⁾

Dean J. Paranicas, president and CEO of the HealthCare Institute of New Jersey (HINJ), details the overall “high-risk profile” for the biopharmaceutical industry: “There’s that challenge of having enough capital to develop your product, being able to get it through the regulatory cycle, and then commercializing [it] and getting it into the marketplace.”⁽⁴⁰⁾

Paranicas additionally explains that New Jersey firms have beneficial opportunities to coordinate with the state’s research institutions as well as with more established companies located here.⁽⁴⁰⁾

Also helping to lubricate the state’s growing industry is New Jersey’s proximity to Wall Street and, separately, a time-zone advantage, which facilitates business communication with locales as diverse as, say, California and the United Kingdom.⁽⁴⁰⁾

In November of 2022, Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) announced it had secured $3.6 million through New Jersey Economic Development Program.⁽⁴⁵⁾

“This was the first year that Citius qualified for the program, and we are delighted to have been selected to participate in New Jersey’s NOL Program. As a pre-revenue business, this program allows us to convert certain losses from operations into tangible working capital today, supporting our ongoing research and development efforts. We are thankful to the NJ Economic Development Authority for aiding our efforts in our initial year of participation. This non-dilutive funding will provide added cash runway as we advance a late-Phase 3 trial for Mino-Lok®, a Phase 2b trial for Halo-Lido, and a recently submitted biologics license application (BLA) for I/ONTAK,” stated Jaime Bartushak, Chief Financial Officer of Citius.⁽⁴⁵⁾

CITIUS PHARMACEUTICALS, INC. (NASDAQ: CTXR) RECEIVES FDA COMPLETE RESPONSE LETTER FOR LYMPHIR™ IN CUTANEOUS T-CELL LYMPHOMA ⁽⁵⁶⁾

Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) recently announced that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for LYMPHIR™ (Denileukin Diftitox). This innovative engineered IL-2-diphtheria toxin fusion protein was developed for the treatment of patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL) who have undergone at least one prior systemic therapy. ⁽⁵⁶⁾

The FDA’s response focuses on the need for enhanced product testing and additional controls, which were agreed upon during the market application review process. Notably, the agency’s feedback did not raise any concerns regarding the safety and efficacy clinical data package submitted with the BLA or the proposed prescribing information.

Leonard Mazur, Chairman and CEO of Citius, expressed the company’s gratitude for the FDA’s expedited review and its commitment to meeting the requirements for LYMPHIR’s approval. He stated, “We appreciate the FDA’s expeditious review of our application. We intend to provide additional data and remain fully engaged with the FDA as we continue to work toward approval. We remain confident in the potential of LYMPHIR to become an important addition to the treatment landscape for patients with relapsed or refractory CTCL and make a meaningful difference in their lives.” ⁽⁵⁶⁾

LYMPHIR™: A Promising Treatment for CTCL ⁽⁵⁶⁾
LYMPHIR is a recombinant fusion protein that combines the interleukin-2 (IL-2) receptor binding domain with diphtheria toxin fragments. This unique agent specifically targets IL-2 receptors on cell surfaces, leading to the inhibition of protein synthesis within cells. The FDA previously granted orphan drug designation to LYMPHIR in 2011 and 2013 for the treatment of peripheral T-cell lymphoma (PTCL) and CTCL, respectively. In 2021, denileukin diftitox received regulatory approval in Japan for the treatment of CTCL and PTCL. Subsequently, Citius acquired an exclusive license with rights to develop and commercialize LYMPHIR in all markets, excluding Japan and certain parts of Asia.

Understanding Cutaneous T-Cell Lymphoma (CTCL)
Cutaneous T-cell lymphoma is a subtype of cutaneous non-Hodgkin lymphoma (NHL) and represents the most prevalent form of cutaneous lymphoma. This condition manifests in various forms, and CTCL is characterized by cancerous T-cells that develop into skin lesions. Consequently, CTCL significantly impacts the quality of life for affected individuals due to severe pain and pruritus. The majority of CTCL cases comprise Mycosis Fungoides (MF) and Sézary Syndrome (SS). The disease progression varies, with some cases progressing slowly over several years, while others reach a highly malignant tumor stage more rapidly, affecting lymph nodes and internal organs.

CTCL predominantly affects men and is typically diagnosed in patients between the ages of 50 and 60. Despite multiple treatment options, including allogeneic stem cell transplantation for a select few, there is currently no curative therapy for advanced CTCL. ⁽⁵⁶⁾

Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) remains committed to addressing the unmet medical needs of patients with CTCL and is actively working toward the FDA’s requirements for LYMPHIR’s approval, potentially opening new doors for patients battling this challenging disease.

CITIUS PHARMACEUTICALS, INC. (NASDAQ: CTXR) ACHIEVES MILESTONE IN MINO-LOK® PHASE 3 TRIAL ⁽⁵⁸⁾

Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) has reached a significant milestone in its clinical trial for Mino-Lok®, an innovative antibiotic lock solution designed to salvage catheters in patients grappling with catheter-related bloodstream infections.⁽⁵⁸⁾ The company’s announcement marks a momentous step forward in advancing healthcare solutions that can potentially improve patient outcomes while reducing the burden on the healthcare system.

Reaching the 92 Event Milestone
Citius Pharmaceuticals has revealed that pending confirmation from an adjudication committee of independent reviewers, it believes to have achieved all 92 events required to complete the Phase 3 Mino-Lok trial. This achievement is paramount as the company moves closer to completing the trial successfully.

Leonard Mazur, Chairman and Chief Executive Officer of Citius, emphasized the significance of this milestone, stating, “This is a significant milestone for Citius as we approach completion of the Phase 3 Mino-Lok trial. As we complete therapy for patients in active treatment, we will continue to enroll patients in the pipeline and initiate shutdown activities.” ⁽⁵⁸⁾

Mino-Lok Phase 3 Trial Design
The Phase 3 pivotal superiority trial, registered under NCT02901717, is a multi-center, randomized, open-label, blinded study that aims to assess the efficacy and safety of Mino-Lok (MLT). This innovative antibiotic lock therapy combines minocycline with edetate disodium and is being conducted in the United States and India.

The primary endpoint of the trial is the time (in days following randomization) to a catheter failure event between randomization and TOC (Week 6) in the Intent-to-Treat (ITT) Population. Additional secondary outcome measures include overall success, microbiological eradication, and clinical cure, among others.

Patients diagnosed with catheter-related bloodstream infections (CRBSI/CLABSI) who meet the necessary criteria for the study are randomized in a 1:1 ratio to receive either Mino-Lok therapy or standard-of-care antibiotic lock therapy.

In the Mino-Lok arm, patients receive one MLT dose daily with a dwell time of two to four hours for a total of seven doses. For subjects in the Control arm, the investigator determines the antibiotic used in the lock, dose, dwell time, and number of days of administration based on institutional standards or Infectious Diseases Society of America (IDSA) guidelines. ⁽⁵⁸⁾

CITIUS PHARMACEUTICALS, INC. (NASDAQ: CTXR) JOINS THE RUSSELL 3000® AND RUSSELL 2000® INDEXES ⁽⁶⁰⁾

Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) has proudly announced its inclusion in the esteemed Russell 3000® Index and the small-cap Russell 2000® Index as part of the annual reconstitution of Russell US Indexes. ⁽⁶⁰⁾

Leonard Mazur, Chairman and CEO of Citius, expressed his satisfaction with the news, saying, “We are pleased to be included, once again, in the Russell U.S. Equity Indexes and welcome the enhanced visibility this brings to our diversified late-stage pipeline.” ⁽⁶⁰⁾

FTSE Russell, a global leader in index expertise and products, employs a meticulous selection process for its Russell indexes, primarily based on objective market-capitalization rankings and style attributes. Membership in the Russell 2000® Index, a small-cap index that lasts for one year, is predicated on inclusion in the broader Russell 3000® Index. Citius Pharmaceuticals, Inc. (Nasdaq: CTXR)’s stock will also automatically be incorporated into the appropriate growth and value indexes.

The significance of this move extends beyond mere recognition; it signifies Citius Pharmaceuticals, Inc. (Nasdaq: CTXR)’s growing prominence and potential in the biopharmaceutical sector. With a late-stage pipeline dedicated to the development and commercialization of critical care products, the company’s inclusion in these Russell indexes underscores its commitment to delivering innovative solutions in the healthcare industry.

FTSE Russell’s indexes hold immense weight in the financial world, with institutional and retail investors worldwide relying on their expertise. Currently, approximately $20.1 trillion is benchmarked to FTSE Russell’s indexes, including a substantial $12.1 trillion that is linked to the Russell US Equity Indexes.

Citius Pharmaceuticals, Inc. (Nasdaq: CTXR)’s addition to the Russell 3000® and Russell 2000® Indexes not only raises its profile in the market but also reflects the company’s growth potential and commitment to advancing healthcare solutions.

As it continues to make strides in its late-stage pipeline, Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) appears poised for a promising future, further solidifying its position in the biopharmaceutical sector. Industry stakeholders will be closely watching the company’s journey as it navigates this significant milestone. ⁽⁶⁰⁾

NEWS

09/06/2023

Citius Pharmaceuticals to Participate in H.C. Wainwright and Sidoti Investor Conferences in September 2023

08/14/2023

Citius Pharmaceuticals, Inc. Reports Fiscal Third Quarter 2023 Financial Results and Provides Business Update

08/10/2023

Citius Pharmaceuticals Reaches 92 Event Milestone in Mino-Lok® Phase 3 Trial

07/29/2023

Citius Pharmaceuticals, Inc. Receives a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for LYMPHIR™ (Denileukin Diftitox) for the Treatment of Patients with Relapsed or Refractory Cutaneous T-Cell Lymphoma

06/26/2023

Citius Pharmaceuticals to be Added to Russell 3000® and Russell 2000® Indexes

06/20/2023

Citius Pharmaceuticals Announces Positive Results from the Phase 2b Study of Halo-Lido (CITI-002) for the Treatment of Hemorrhoids

06/13/2023

Citius Pharmaceuticals to Participate in Maxim Group’s Virtual Healthcare Conference on June 21, 2023

05/12/2023

Citius Pharmaceuticals, Inc. Reports Fiscal Second Quarter 2023 Financial Results and Provides Business Update

05/08/2023

Citius Pharmaceuticals Announces Closing of $15 Million Registered Direct Offering

05/04/2023

Citius Pharmaceuticals Announces $15 Million Registered Direct Offering

04/24/2023

Citius Pharmaceuticals Advances Mino-Lok® Phase 3 Trial Achieving 85 of 92 Events to Date

04/03/2023

Citius Pharmaceuticals Completes Enrollment in Phase 2b Study of Halo-Lido for the Prescription Treatment of Hemorrhoids

03/30/2023

Citius Pharmaceuticals Advances Efforts to Spin Off Oncology Asset, I/ONTAK, into a Standalone Public Company

03/13/2023

Citius Pharmaceuticals Confirms No Exposure to Silicon Valley Bank

03/08/2023

Citius Pharmaceuticals to Participate in the 35th Annual Roth Conference

02/10/2023

Citius Pharmaceuticals, Inc. Reports Fiscal First Quarter 2023 Financial Results and Provides Business Update

01/11/2023

Citius Pharmaceuticals to Present at the Sidoti Micro-Cap Virtual Conference on January 18, 2023

MANAGEMENT

LEONARD MAZURCO-FOUNDER, CEO AND CHAIRMAN OF THE BOARD OF DIRECTORS

Mr. Mazur is an accomplished entrepreneur and pharmaceutical industry executive with notable success in founding and building multiple healthcare companies and creating value and returns for investors throughout his five-decade career. Mr. Mazur was the co-founder and Chairman of Leonard-Meron Biosciences, Inc. prior to its merger with Citius in March 2016. He was previously the co-founder and Vice Chairman of Akrimax Pharmaceuticals, LLC, which specialized in cardiovascular and general pharmaceutical products. From 2005 to 2012, Mr. Mazur co-founded and served as the Chief Operating Officer of Triax Pharmaceuticals LLC, a specialty pharmaceutical company producing prescription dermatological drugs. As founder and Chief Executive Officer of Genesis Pharmaceuticals, Inc., a dermatological products company that marketed its products through dermatologists’ offices and co-promoted products for major pharmaceutical companies, he successfully negotiated the company’s sale in 2003 to Pierre Fabre, a leading global pharmaceutical company. Mr. Mazur has extensive sales, marketing, and business development experience from previous tenures at Medicis Pharmaceutical Corporation, ICN Pharmaceuticals, Inc., Knoll Pharma (a division of BASF), and Cooper Laboratories, Inc. Mr. Mazur was born in Ansbach, Germany, and emigrated with his family to the U.S. at an early age. Mr. Mazur served in the U.S. Marine Corps Reserve while studying at Temple University for his undergraduate degree. He earned his MBA from Temple University’s Fox School of Business in 1975. Mr. Mazur is a recipient of the Ellis Island Medal of Honor presented annually to those who immigrated to the United States during the Ellis Island era and have shown an outstanding commitment to serving the United States either professionally, culturally, or civically.

MYRON HOLUBIAKCO-FOUNDER, EXECUTIVE VICE CHAIRMAN

Mr. Holubiak has extensive experience in managing and leading both large and emerging pharmaceutical and life sciences companies. Mr. Holubiak was co-founder, director and CEO of Leonard-Meron Biosciences, Inc. prior to its merger with Citius in March 2016. Mr. Holubiak was the President of Roche Laboratories, Inc., a premier multinational research-based pharmaceutical company, from 1998 to 2001. As President of Roche, Mr. Holubiak helped transform Roche Labs into a leading antibiotic and biotechnology company. Before being named President, he held sales and marketing positions at Roche during his 19-year tenure. Earlier, Mr. Holubiak founded Emron, Inc., a health economics and managed care consulting company, and helped to create the Academy of Managed Care Pharmacy (AMCP). He was also a director of Bioscrip, Inc., a national home infusion company, serving as its Chairman of the Board from 2012 through 2016. Since 2010, Mr. Holubiak has served as a member of the Board of Directors of Assembly Biosciences, Inc. and its predecessor, Ventrus Biosciences, Inc., and is a trustee of the Academy of Managed Care Pharmacy Foundation. Mr. Holubiak received a BS in molecular biology and biophysics from the University of Pittsburgh. He received advanced business training from Harvard Business School and the University of London, as well as advanced training in health economics from the University of York’s Centre for Health Economics.

JAIME BARTUSHAKCHIEF FINANCIAL OFFICER & CHIEF BUSINESS OFFICER

Mr. Bartushak is an experienced finance and operations professional for early-stage pharmaceutical companies, and has over 20 years of corporate finance, business development, M&A, restructuring, capital formation, and strategic planning expertise. Mr. Bartushak is a founder of Leonard-Meron Biosciences, and, as CFO, was instrumental in obtaining initial investment capital for its start-up in 2014. Earlier, Mr. Bartushak helped lead the sale of PreCision Dermatology, Inc. to Valeant Pharmaceuticals International, Inc., and before that, he led the financial efforts for the successful sale of Triax Pharmaceuticals to PreCision Dermatology. Mr. Bartushak holds a Master of Science and BS from the New Jersey Institute of Technology.

MYRON S. CZUCZMAN, MDCHIEF MEDICAL OFFICER AND EVP

Dr. Czuczman is an experienced physician-scientist, academic oncologist, and pharma executive with decades of experience in strategic design, implementation, and oversight for the global development of novel therapeutics for hematologic malignancies. Dr. Czuczman joined Citius from Celgene where he was Vice President, Global Clinical Research and Development, Therapeutic Area Head of Lymphoma/CLL. In this role, Dr. Czuczman managed a global team of physicians and scientists responsible for cross-functional development of compounds from proof-of-principle to worldwide registration. Prior to his career in pharma, Dr. Czuczman practiced medicine for over two decades at Roswell Park Cancer Institute, an NCI-designated comprehensive cancer center in Buffalo, NY, where he served as chief of the Lymphoma/Myeloma Service and head of the Lymphoma Translational Research Laboratory. In addition to his extensive publications record, membership and leadership roles on national and international research organizations, and consulting and advisory to dozens of pharma companies, Dr. Czuczman also attained the positions of tenured Professor of Medicine at the State University of New York at Buffalo School of Medicine and Biomedical Sciences and Professor of Oncology at Roswell Park Comprehensive Cancer Center. Dr. Czuczman received his medical degree from the Pennsylvania State University College of Medicine after graduating magna cum laude in biochemistry from the University of Pittsburgh. He completed his Internal Medicine residency training at Weill Cornell North Shore University/MSKCC Program, followed by Medical Oncology/Hematology fellowship training at Memorial Sloan-Kettering Cancer Center in New York City.

GARY F. TALARICOEVP, OPERATIONS

Mr. Talarico has served as EVP, Operations since March 2016. Mr. Talarico has successfully built and led all commercial activities for a number of start-up companies. Most recently, he was a founder, partner and Executive Vice President of Leonard-Meron Biosciences, Inc.; he was instrumental in acquiring its lead product. Previously, Mr. Talarico served as Senior Vice President of Triax Pharmaceuticals, from its founding to the sale of its assets. Mr. Talarico was a founder and Executive Vice President of Sales and Marketing for Reliant Pharmaceuticals, LLC; Reliant was later sold to GlaxoSmithKline plc. Before Reliant, he was Executive Vice President of Business Development for Ventiv Health. His earlier experience included tenures as Vice President of Sales for Medicis Pharmaceutical Corporation at its start-up, and Director of Sales at ICN Pharmaceuticals, Inc. Mr. Talarico is a graduate of Lewis University.

JAY WADEKARSVP, BUSINESS STRATEGY

Mr. Wadekar has been associated with Citius since its inception. Prior to Citius, he lead the clinical program at Ischemix, Inc., a company developing novel therapies for cardiovascular conditions. Mr. Wadekar has more than thirty years of experience in areas of finance, corporate strategy, sales and senior leadership in the healthcare field. Mr. Wadekar has held numerous executive level positions throughout his career in biotechnology and pharmaceutical industries including Chairman and CEO of Able Laboratories, Inc. Most recently he served as a strategic advisor to Camber Pharmaceuticals, Inc. where he was instrumental in building the executive team and establishing Camber’s Sales Operations systems.

KELLY CREIGHTON, PHDEVP, CHEMISTRY, MANUFACTURING AND CONTROLS

Kelly joined Citius from Clinipace Worldwide, a leading global contract research organization, where he served as Vice President of Regulatory and Strategic Development. As a senior-level regulatory affairs and quality assurance expert with nearly two decades of experience in biopharmaceuticals, pharmaceuticals, advanced therapies, including gene and cellular therapies, and combination products, he has provided comprehensive regulatory strategy assessments, development plans and regulatory dossiers for programs across a wide range of therapeutic areas. As head of a global CMC regulatory activities for investigational products, he has led teams throughout North America, Europe and the Asia Pacific region overseeing submissions and negotiations with regulatory authorities, as well as biosafety and environmental agencies in each of these regions. Kelly has directed the implementation of multiple CMC development plans including: contract manufacturing organization selection, product manufacturing, analytical development, product characterization, specification establishment, container closure systems and stability requirements. Additionally, his substantial product development experience extends to biologics/biosimilars, small molecule, gene and cellular therapies, cancer immunotherapies, live oncolytic biotherapeutics, and microbiome therapies. Twenty products for which he prepared regulatory marketing applications (NDAs, ANDAs, and BLAs) were approved in the US and EU. Additionally, he has performed internal and external quality assurance audits for drug products, drug substance, and tissue and cell therapy products. Kelly earned his BS from New Mexico State University and his MSc and PhD from the University of Nebraska.

ALAN LADER, PHDSVP, HEAD OF CLINICAL OPERATIONS AND QUALITY ASSURANCE

Dr. Lader has over 25 years of experience in medical research. Prior to joining Citius, Dr. Lader was the Director of Clinical Operations for Ischemix, Inc. Dr. Lader was an Instructor in Medicine at Harvard Medical School and Brigham and Women’s Hospital, where he taught Integrated Human Physiology, and was Principal Investigator for NIH-funded studies in mechanisms of lung cancer metastasis. Dr. Lader has authored over 20 publications in peer-reviewed journals, and has presented more than 20 abstracts at scientific meetings. He received his PhD from the University of South Carolina School of Medicine. He received an MS degree from Rensselaer Polytechnic Institute in Biomedical Engineering and a BS degree in Bioengineering from Syracuse University.

ILANIT ALLENVP, INVESTOR RELATIONS

Ms. Allen has more than 20 years of experience in corporate communications, investor relations, strategy and investment banking. Since 2014, Ms. Allen has provided investor relations counsel to more than two dozen private and public life science companies. Previously, she advised executives across a broad spectrum of industries and growth stages, including technology startups and Fortune 500 financial institutions. Ilanit began her career as an investment banking analyst at SG Cowen with a focus on mergers and acquisitions. Ms. Allen holds an MBA from Harvard Business School, a Bachelor of Science degree in Finance from The Wharton School, and a Bachelor of Arts degree in International Relations from the University of Pennsylvania.

JOHN WESTMANVP, PROJECT MANAGEMENT

John Westman has led commercial efforts—including strategy, sales management, marketing, business development, customer service and strategic partnerships—resulting in improved business results for market-leading and start-up healthcare companies. Prior positions include co-founder and Executive Vice President of Novellus, Inc., General Manager and Vice President of Marketing and Sales for PrecisionMD, NxStage, Fresenius, PharMetrics and Decision Resources Pharmaceutical. John led U.S. and global marketing and sales training at Baxter Healthcare’s Renal division and started his career at Bain Consulting/Baxter consulting firm. John is a Fulbright Scholar who received a B.A. in French and English from Colgate, an M.A. in international relations from the University of Wisconsin, and an MBA in marketing and finance from the Kellogg Graduate School of Management at Northwestern. John is on the faculty at Harvard and Boston College.

PAUL SOWYRDAVP, BUSINESS DEVELOPMENT & MARKET INTELLIGENCE

Paul Sowyrda is a seasoned Biopharmaceutical leader and inventor with over 25 years of experience helping to build and lead development stage and commercial companies. He is co-founder of Novellus, Inc. which was sold to Brooklyn ImmunoTherapeutics, Inc. in July 2021, and served as its Executive Vice President. Mr. Sowyrda held previous positions as Vice President of Drug Development at CIBA, and Vice President of Development and Marketing at Dusa Pharmaceuticals, which was acquired by Sun Pharma. Mr. Sowyrda is an inventor and holds more than 15 patents, He has served on the Board of Directors for the Society of Concurrent Product Development and is a member of the American Academy of Dermatology and International Society of Dermatologic Surgery. He earned his B.S. and M.S. from the University of Notre Dame, his MBA from Babson College, and completed the MIT Sloan School of Management Senior Executives Program.

SINCERELY,

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SOURCE LIST

https://www.prnewswire.com/news-releases/citius-receives-positive-fda-feedback-on-its-submitted-plan-to-study-catheter-compatibility-for-mino-lok-therapy-301069349.html
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Source 8: https://www.citiuspharma.com/wp-content/uploads/2021/02/CTXR_Shareholder_Letter_Feb2021.pdf
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Source 27: https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-ctxr/citius-pharmaceuticals#intrinsic-value
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OUR NEW PROFILE IS:  (NASDAQ: SKYX)

SKYX HAS OVER 60 U.S. AND GLOBAL PATENTS AND PATENTS PENDING APPLICATIONS WITH 15 ISSUED PATENTS IN THE U.S. AND GLOBALLY  

SKYX ALREADY HAS A GLOBAL LICENSING AGREEMENT WITH GENERAL ELECTRIC

SKYX GENERATED $15 MILLION IN REVENUE IN THE SECOND QUARTER OF 2023

 CEILING SMART AND STANDARD PLUG AND PLAY PRODUCTS THAT ARE NOW ON 16 LEADING U.S. AND CANADIAN WEBSITES

READ THE INVESTOR PRESENTATION HERE

__________________________________________

Hello Everyone,

We have another brand new profile for you to research for tomorrow’s session.

This is another company that we have never featured on this newsletter before.

There are several strong catalysts in play right now that you need to research immediately.

Pull up SKYX right away.

SKYX Platforms Corp (NASDAQ: SKYX) Sky Technologies has a series of highly disruptive advanced-safe-smart platform technologies, with over 60 U.S. and global patents and patent pending applications. Our technologies place an emphasis on high quality and ease of use, while significantly enhancing both safety and lifestyle in homes and buildings. We believe that our products are a necessity in every room in both homes and other buildings in the U.S. and globally.

SKYX Platforms first-generation technologies enable light fixtures, ceiling fans and other electrically wired products to be installed safely and plugged in to a ceiling’s electrical outlet box within seconds, and without the need to touch hazardous wires. The plug and play technology method is a universal power-plug device that has a matching receptacle that is simply connected to the electrical outlet box on the ceiling, enabling a safe and quick plug and play installation of light fixtures and ceiling fans in just seconds.

The plug and play power-plug technology eliminates the need of touching hazardous electrical wires while installing light fixtures, ceiling fans and other hard wired electrical products. In recent years, we have developed prototypes that expand the capabilities of our powerplug product, to include advanced safe and quick universal installation methods, as well as advanced smart capabilities, which are currently in the third and final prototype stage prior to launching.

The smart features contained in the final prototype include control of light fixtures and ceiling fans by the SkyHome App, through WIFI, Bluetooth Low Energy (“BLE”) and voice control connections. The SkyHome App will allow scheduling, energy savings eco mode, dimming, back-up emergency light, night light, light color changing and much more.

The Smart Sky Platform technology is an open system that can integrate with both existing and new smart home features, devices, and systems. The Smart SkyPlatform prototype is designed and built in a way that it can accommodate additional smart home features, enabling the platform to serve as a gateway for safe and smart technologies into rooms/homes, buildings, and that it can act like a “Panama-Canal” that can accommodate other type of software systems, wireless systems, electronic chips and more.

WORKS WITH…

MARKET

Our Opportunity Based on the significance of the safety aspects and lifestyle features of our products, we believe that our products are a necessity in most rooms, homes, and other buildings, both in the U.S. and globally, and that they can help prevent most related hazardous incidents in homes and buildings, including ladder falls, electric shock/electrocutions, fires, carbon monoxide poisonings, injuries, and deaths. Therefore, we believe our product is a necessity in rooms, homes and other buildings.

We believe that our series of highly disruptive advanced-safe-smart platform technologies are a necessity as they are expected to disrupt and positively influence various industries, both in the U.S. and globally

• Lighting Industry: We believe that due to ease of the installation, time savings, cost savings on installations and the safety aspect of our product, our product provides a competitive advantage within the light fixture, ceiling fan and smart home industries. We believe that all light fixtures should become plug and play, smart and controlled by an app as a standard, and that light fixtures should be installed to the ceiling within seconds, safely and without the need to touch dangerous electrical wires. Our product is intended to help prevent most of related ladder falls, electric shock/electrocutions, fires, carbon monoxide poisonings, injuries, and deaths.
• Ceiling Fan Industry: We believe that due to the ease of installation, time savings, cost savings on installations and the safety aspect of our product, our product is a necessity for the ceiling fan industry. We believe that all ceiling fans should become plug and play, smart and controlled by an app as a standard, and that ceiling fans should be installed to the ceiling within seconds, safely and without the need to touch dangerous electrical wires. Our product is intended to help prevent most of related ladder falls, electric shock/electrocutions, fires, carbon monoxide poisonings, injuries, and deaths.
• Smart Home Industry: We believe that due to ease of the installation, time savings, cost savings on installations and the safety aspect of our product, our product is a necessity for the smart home industry.

SKYX REPORTS SECOND QUARTER 2023 FINANCIAL RESULTS WITH $15 MILLION IN SALES REFLECTING A PARTIAL QUARTER INCLUDING SALES OF ITS SAFE PLUG & PLAY PRODUCTS

Company Sequentially Reduces Net Cash Used in Operating Activities to $2.5 Million

MIAMI, FL / ACCESSWIRE / August 9, 2023 / (NASDAQ:SKYX) (d/b/a “Sky Technologies”), a highly disruptive platform technology company with over 60 pending and issued patents globally with a mission to make homes and buildings become safe and smart as the new standard, today reported its financial and operational results for the second quarter ended June 30, 2023.

Second Quarter 2023 and Subsequent Operational Highlights

• Generated $15 million in revenue in the second quarter of 2023, reflecting a partial quarter of sales, including commencement of sales of its smart and standard plug & play products.
• Sequentially reduced net cash used in operating activities to $2.5 million in the quarter.
• Cash, cash equivalents, restricted cash, and investments available for sale totaled $23.7 millionas of June 30, 2023, as compared to $16.8 million as of December 31, 2022.
• Appointed several strategic advisors, including:
  • Khadija Mustafa, former Microsoft AI and global business leader, as a Senior Tech, AI and Global Business Advisor.
  • Eric Jacobson, former President, and CEO of The American Lighting Association (ALA), as a Senior Product Standardization Advisor.
  • Al Weiss, former President of Worldwide Operations at Walt Disney Parks, Resorts and Cruises, as a Senior Business Development Advisor.
• Joined the broad-market Russell 2000® and Russell 3000® Indexes at the conclusion of the 2023 Russell Indexes annual reconstitution.
• Successfully acquired Belami E-commerce, a profitable conglomerate with 64 websites for lighting and home décor. The acquisition was primarily funded using the Company’s stock, while the cash portion was funded by two major SKYX investors.
• The E-commerce acquisition is expected to enhance the Company’s cash-flows, speed up time to market for SKYX ceiling safe plug & play smart and standard products, as well as expand distribution across professional and retail segments while concurrently serving as a marketing and education platform.

Safety Standardization Highlights

The Company is eligible to apply for a building safety standardization requirement with the National Electrical Code (NEC) for its ceiling outlet receptacle and is expected to file its application within the next few weeks.

Management believes that after over 12 years of its standardization process including its product specification approval voting for by ANSI / NEMA (American National Standardization Institute / National Electrical Manufacturing Association), it has met the necessary safety conditions for becoming a ceiling safety standardization requirement for homes and buildings. In the past 12 years the Company’s product was voted into 10 segments in of the NEC Code Book. Voting decisions are at the discretion of the NEC voting members.

The Company’s code team is led by Mark Earley – former head of the National Electrical Code (NEC) and former Chief Electrical Engineer of the National Fire Protection Association (NFPA) – as well as Eric Jacobson, former President and CEO of The American Lighting Association (ALA).

Second Quarter 2023 Financial Results

Revenue in the second quarter of 2023 increased to $15.0 million, including E-commerce sales as well as smart and standard plug and play products, reflecting a partial quarter of approximately 60 days of sales.

Gross profit in the second quarter of 2023 increased to $4.7 million, or 31.3% of revenue. Gross profit was positively impacted by a partial quarter of gross profit from the aforementioned acquisition of Belami E-commerce.

Cash, cash equivalents, restricted cash, and investments available for sale totaled $23.7 million as of June 30, 2023, as compared to $16.8 million as of December 31, 2022.

Cash used in operating activities for the three months ended June 30, 2023 totaled $2.5 million, as compared to $2.8 million in the same year-ago period.

The Company’s current liabilities include a 2024 non-cash payment of $5.6 million, payable in shares to the Belami shareholders as part of the consideration for the acquisition.

Operating expenses in the second quarter of 2023 included $8.2 million in non-cash share-based payments as well as depreciation and amortization, $2.2 million of which were to new employees following the Belami acquisition, in addition to $5.0 million in cash for Belami selling, general and administrative expenses (SG&A) and $3.7 million for SKYX SG&A totaling $17.0 million, as compared to SKYX SG&A of $4.6 million (which included $2.4 million of non-cash shared-based payments) in the second quarter of 2022. The increase in operating expenses were primarily driven by the acquisition of Belami, offset by the improved operating expense structure of SKYX.

Net loss in the second quarter of 2023 (which included $8.7 million in non-cash share-based payments as well as depreciation and amortization, and $3.6 million in cash) totaled $12.3 million, or $(0.14) per share, as compared to a net loss of $4.6 million (which included $2.4 million of non-cash shared-based payments), or $(0.06) per share, in the second quarter of 2022. The increase in operating expenses were primarily driven by the acquisition of Belami, offset by the improved operating expenses of SKYX.

EThe Company’s financial statements for the quarter ended June 30, 2023 will be filed with the SEC and are available on the Company’s investor relations website.

EXPECTED REVENUE STREAM

Expected Revenue Stream We believe our products will enable us to access a global market with multiple revenue streams, including:

• Global market with numerous potential product applications
• Product sales
• Royalties/Licensing
• Subscription model
• Monitoring services
• Sale of product and licensing rights to additional countries

Royalties from the Sky Plug & Receptacle. Management has agreed to license products in the U.S. and globally through the efforts of its GE licensing and trademark agreements. We anticipate we will also license our smart technologies products currently in development.

Selling/Licensing Country Rights. Management is considering selling and licensing marketing rights to certain countries in exchange for payment and ongoing royalties.

Product Sales. We currently generate revenue from our product sales, and management will strive to achieve strong market penetration worldwide for our current products and products in development. We have previously sold our standard products in the United States, Canada and Mexico, and expect to begin selling our new smart products in these markets in 2023. We intend to expand our sales footprint in certain countries in Latin America, Europe and Asia. We may be unable to gain market acceptance in such markets and cannot provide any assurance that we will be successful in our efforts to expand our market reach.

Subscription & Monitoring Services. Our future plans include offering subscription services as part of our Smart Sky Platform, including, among other services, communications, fire alarms, home intrusion alerts, emergency response services and monitoring services. Our smart platform will include, among other features, a smart smoke detector, a smart carbon monoxide detector, and a WIFI extender.

RECENT CATALYSTS:

• WestPark Capital analyst Greg Mesniaeff initiated coverage of SKYX Platforms (NASDAQ:SKYX) “strong buy” rating and a price target of $7.00
• Revenue growth thanks to partnership with General Electric (GE)
• Over 60 U.S. and global patents
• Generated $15 million in revenue in the second quarter of 2023, reflecting a partial quarter of sales, including commencement of sales of its smart and standard plug & play products
• Cash, cash equivalents, restricted cash, and investments available for sale totaled $23.7 millionas of June 30, 2023, as compared to $16.8 million as of December 31, 2022
• Joined the broad-market Russell 2000® and Russell 3000® Indexes at the conclusion of the 2023 Russell Indexes annual reconstitution.
• Average annual growth rate of 159%, which signals high confidence from analysts
• Strategic acquisition of Belami e-commerce, an established lighting and home décor company with 64 websites, $88Mln in revenues

NEWS

PUBLISHED

AUG 9, 2023

SKYX REPORTS SECOND QUARTER 2023 FINANCIAL RESULTS WITH $15 MILLION IN SALES REFLECTING A PARTIAL QUARTER INCLUDING SALES OF ITS SAFE PLUG & PLAY PRODUCTS

PUBLISHED

AUG 4, 2023

SKYX PLATFORMS CORP. TO HOST INVESTOR UPDATE CALL ON WEDNESDAY, AUGUST 9TH AT 10:30 A.M. EASTERN TIME

PUBLISHED

AUG 3, 2023

SKYX ANNOUNCES OVER $14 MILLION (UNAUDITED) IN SALES FOR PARTIAL SECOND QUARTER, INCLUDING SALES OF ITS PLUG & PLAY PRODUCTS THAT ARE NOW SOLD ON 16 US AND CANADIAN LEADING WEBSITES

PUBLISHED

JUL 20, 2023

FORMER MICROSOFT GLOBAL AI LEADER AND HEAD OF GLOBAL SALES KHADIJA MUSTAFA JOINS SKYX AS SENIOR TECH, AI, AND GLOBAL BUSINESS ADVISOR

PUBLISHED

MAY 30, 2023

AMERICAN LIGHTING ASSOCIATION (ALA) FORMER PRESIDENT AND CEO ERIC JACOBSON JOINS SKYX AS SENIOR PRODUCT STANDARDIZATION ADVISOR

PUBLISHED

MAY 23, 2023

SKYX SET TO JOIN RUSSELL 2000(R) AND RUSSELL 3000(R) INDEXES

PUBLISHED

MAY 12, 2023

SKYX REPORTS FIRST QUARTER 2023 FINANCIAL RESULTS

PUBLISHED

MAY 1, 2023

SKYX NOW OWNS NEARLY HALF OF U.S. LIGHTING WEBSITES AFTER CLOSING STRATEGIC ACQUISITION OF A COMPANY WITH $88M IN REVENUES AND $4.3M IN EBITDA IN 2022

PUBLISHED

APR 3, 2023

FORMER PRESIDENT OF WORLDWIDE OPERATIONS OF WALT DISNEY PARKS AND RESORTS AL WEISS HAS JOINED SKYX AS A SENIOR BUSINESS DEVELOPMENT ADVISOR

PUBLISHED

MAR 31, 2023

SKYX REPORTS FISCAL YEAR 2022 FINANCIAL RESULTS

PUBLISHED

MAR 9, 2023

SKYX ACQUIRES A $5 MILLION REVENUE STRATEGIC, PROFITABLE E-COMMERCE LIGHTING WEBSITE

PUBLISHED

FEB 7, 2023

SKYX SIGNS TO ACQUIRE STRATEGIC LIGHTING E-COMMERCE CONGLOMERATE WITH $86 MILLION IN REVENUES AND 64 WEBSITES

PUBLISHED

JAN 31, 2023

SKYX TO SHOWCASE ITS REVOLUTIONARY SKYPLUG SMART FOR CEILINGS AT THE NAHB INTERNATIONAL BUILDER’S SHOW IN LAS VEGAS, NV

PUBLISHED

JAN 11, 2023

SKYX’S REVOLUTIONARY SMART CEILING PLUG WINS FIVE TECHNOLOGY AWARDS FROM LEADING TECH PUBLICATIONS AT THE CES SHOW IN LAS VEGAS

PUBLISHED

JAN 4, 2023

SKYX PLATFORMS DEBUTS REVOLUTIONARY SKYPLUG SMART AT CES 2023

MANAGEMENT TEAM

Rani R. Kohen

Founder and Executive Chairman

Rani R. Kohen is a renowned businessman, entrepreneur and the founder of Sky Technologies – currently serving as the Executive Chairman of the board, a role Mr. Kohen has held since 2016. He brings strategic acumen with over 20 years of experience in business, as well as in advanced smart home technologies, product design, lighting, and other related businesses. Since founding the Company, he has succeeded in attracting and engaging accomplished board members, talented management and leading executives from various industries.

John P. Campi

Chief Executive Officer

John P. Campi has served as Chief Executive Officer since November 2014 and served as Chief Financial Officer through December 31, 2021. Mr. Campi founded Genesis Management, LLC in 2009, and retired in 2014 upon joining SKYX Platforms Corp. Mr. Campi has extensive experience in the field of cost management, is recognized as a founder of the strategic cost-management discipline known as Activity-Based Cost Management and has extensive experience in the field of supply chain management. From December 2007 to December 2008, Mr. Campi served as the Chief Procurement Officer and an Executive Vice President for Chrysler, where he was responsible for all worldwide purchasing and supplier quality activities.

From September 2003 to January 2007, Mr. Campi served as the Senior Vice President of Sourcing and Vendor Management for The Home Depot, Inc., where he led the drive for standardization and optimization of The Home Depot, Inc.’s global supply chain. From April 2002 to September 2003, Mr. Campi served as the Chief Procurement Officer and Vice President for DuPont Global Sourcing and Logistics. Prior to 2002, Mr. Campi led the Global Sourcing activities for GE Power Energy and held a variety of positions with Federal Mogul, Parker-Hannifin Corporation and PricewaterhouseCoopers. Mr. Campi previously served on the board of Trustees of Case Western Reserve University and has been appointed an Emeriti Trustee. Mr. Campi also has served as a member of the advisory board of directors for three startup companies and has served as a Member of the Financial Executives Institute and the Institute of Management Accountants. Mr. Campi received his MBA from Case Western Reserve University.

Steven M. Schmidt

President

Steven M. Schmidt brings 30+ years of executive experience at firms such as Office Depot and ACNielsen to his role as President of Sky Technologies. In May 2017, Mr. Schmidt formed Schmidt Family Investments LLC, which invests in early stage companies. Mr. Schmidt previously served in a variety of roles at Office Depot, Inc. from July 2007 through May 2016, including as Executive Vice President and President, International from November 2011 to May 2016, Executive Vice President, Corporate Strategy and New Business Development from July 2011 until November 2011 and President, North American Business Solutions from July 2007 until November 2011. Prior to joining Office Depot, Inc., Mr. Schmidt spent 11 years with the ACNielsen Corporation, most recently serving as President and Chief Executive Officer. Prior to joining ACNielsen, Mr. Schmidt spent eight years at the Pillsbury Food Company, serving as President of its Canadian and Southeast Asian operations. He has also held management positions at PepsiCo and Procter & Gamble.

David Pamer

President Wholesale & Retail Channels

David Pamer joined the Company as President of Wholesale & Retail Channels on July 1, 2023.  Prior to joining the Company, Mr. Pamer spent 25 years with Kichler. During his tenure, he held several positions including Chief Financial Officer, Executive Vice President, Supply Chain and Executive Vice President, Sales. Subsequent to Kichler being acquired in 2018, Pamer joined Elk Home as its Chief Executive Officer and during his tenure led the company through the COVID pandemic business climate while simultaneously furthering the development and execution of a transformational business strategy.

Marc-Andre Boisseau

Chief Financial Officer

Marc-Andre Boisseau serves as Chief Financial Officer and as principal financial officer and principal accounting officer since January 1, 2022. Mr. Boisseau is a partner of Boisseau, Felicione & Associates Inc., which provides assurance, advisory and tax services for public and private companies in a variety of industries and which he founded in February 2002. Among other things, Mr. Boisseau served at Citrix Systems, Inc., a publicly-traded software development company, as Corporate Controller from 1995 to December 1999 and as Principal Accounting Officer from March 1997 to December 1999, and as a senior auditor at Ernst & Young. Mr. Boisseau is a certified public accountant.

Patricia Barron

Chief Operations Officer

Patricia Barron has served as Chief Operations Officer since June 2007. Prior to joining the Company, Ms. Barron was the President and owner of LTG Services, Inc., a company focused on safety consulting services, specializing in the review and compliance of electrical products requiring UL, CSA, and CE certifications, since 1989. Prior to that, Ms. Barron worked as a consultant and engineer in the lighting, safety and approval industry and, from June 1977 to August 1984, worked as an engineering assistant for Underwriters Laboratories, Inc. (n/k/a UL) in the ceiling fan category. Ms. Barron received her MBA from Georgia State University.

Rob Powell

Chief Compliance Officer and General Counsel

Rob Powell has served as General Counsel since June 1, 2022 and Chief Compliance Officer since April 1, 2023.  Prior to joining the Company, Mr. Powell was counsel with Thompson Hine LLP, where he practiced corporate law with a focus on capital markets, public company compliance and reporting and commercial contracts.  Mr. Powell began representing the Company in 2012, while at Thompson Hine LLP.  Prior to practicing law, Mr. Powell was a senior manager at KPMG Consulting, where he worked as a finance and information systems engineer for for manufacturing and technology companies.

Mark Earley

Chair, Safety Advisory Board

World leading electrical engineer and former head of the NEC for 35 years. Joined Sky in 2019 to lead the Global Code team. Mr. Earley remains a leading member in several global codes standards organizations.

Amy Cronin

Executive Director Codes and Standards

Ms. Cronin is a former NFPA (NEC) Executive Leader, managing the Department of Codes and Standards, and she was responsible for more than 300 code decisions including the NEC (National Electrical Codes).

Michael Perrillo

Vice President Global Sales

Michael Perrillo is the former Chief Executive Officer of Design Solutions International. He joined the Company as a full-time consultant to enhance and expand our sales objectives, particularly toward construction/home builders, hotels and other sales channels that we are targeting.

Eliran Ben-Zikri

Chief Technology Officer and GM of Sky’s Israeli Office

Eliran Ben-Zikri joined the Company in 2019 as Chief Technology Officer and GM of Sky’s Israeli Office. He served in one of the most elite computer units of the Israeli Defense Force and has over 10 years of experience in the technology and cloud technology industry, previously holding senior positions in leading Israeli tech companies, including eToro and SimilarWeb. He has a vast experience in the Internet of Things, data collection, data processing, analytics, security, cloud, and production.

Jonathan Globerson

Vice President Design and Marketing

In 2016, Jonathan Globerson, Vice President Design and Marketing, joined the Company. He served in the most elite counter terrorism unit in the Israeli Defense Force (Sayeret Matkal) as head of the technology department, is an international award-winning product developer, former lead product designer of augmented reality and virtual reality for the 5G team for Verizon and founder of GloberDesign, a global product design.

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