NLSP

December 18, 2024

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NLS Pharmaceutics and Kadimastem Announce Binding Term Sheet to Merge

Since the last time we looked at it the company completed a 1-40 reverse split, wiping the float down to a mere fraction of what it was

READ THE INVESTOR PRESENTATION HERE

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Hello Everyone,

There is no doubt that small caps are back.

We have been waiting for this moment.

The Russel 2000, which is the benchmark index for small caps is up 12% YTD and 15% over the past year.

If that isn’t proof enough just look at the companies we have profiled over the past 60 days.

We don’t need to look further than yesterday.

The Biotech that we brought to your attention Tuesday night closed at 1.37 that session. Yesterday it hit 1.81 after opening at 1.42 for a clean 25% move north during the session. Keep watching that one, but we have a time sensitive situation that we want to bring to your attention for today’s session.

This one exploded double digits the last time we took a look at it.

Since the last time we looked at it the company completed a 1-40 reverse split, wiping the float down to a mere fraction of what it was.

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.

The global ADHD market is expected to reach over US$ 70 billion by 2032 growing significantly in the coming years, fueled by rising diagnosis rates and demand for innovative treatments. And amid this growing need, NLSP is making impressive progress with a promising drug that targets not only ADHD but also closely linked sleep-wake disorders.

Their lead candidate is Mazindol ER. This one is Phase 3-ready for ADHD as well as for narcolepsy, also targeting excessive daytime sleepiness—a major unmet need in worldwide that is projected to grow at nearly 10% annually.

With a proven safety profile from prior use as an appetite suppressant, Mazindol ER has the potential to move efficiently through the regulatory pipeline. NLSP has also positioned itself with a clean balance sheet, recently regaining full Nasdaq compliance and clearing all debt while raising $3.2M and with a 12-month cash runway and a binding terms sheet for a merger with Kadimastema, a larger company that has an executive team with experience taking products from the lab to the market.

IsletRx is Kadimastem‘s treatment for diabetes. IsletRx is comprised of functional pancreatic islet cells producing and releasing insulin and glucagon. IsletRx is intended to treat and potentially cure patients with insulin-dependent diabetes.

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.

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

NLS Pharmaceutics CEO Issues Letter to Shareholders

PUBLISHED

DEC 11, 2024 7:30AM EST

ZURICH, SWITZERLAND / ACCESSWIRE / December 11, 2024 / 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 its Chief Executive Officer, Alex Zwyer, has issued the following letter to shareholders:

Dear Valued Shareholders,

As we move forward with exciting developments at NLS, I want to update you on the significant progress we’ve made, key challenges we’ve overcome, and the strategic opportunities that lie ahead-especially as we approach the expected closing of our transformative merger with Kadimastem Ltd. (“Kadimastem”), an advanced clinical-stage company.

The DOXA Program

Over the past several months, we’ve made substantial progress with our Dual Orexin Receptor Agonist (DOXA) platform, which we believe holds considerable promise in addressing key challenges in the treatment of sleep and neurodegenerative diseases. Recently, we announced details around our preclinical program to evaluate two candidates, AEX-41 and AEX-2, two first-in-class non-sulfonamide DOXAs designed to target both orexin-1 (OX1R) and orexin-2 (OX2R) receptors while concurrently inhibiting cathepsins. This unique approach aims to address the unmet therapeutic needs in narcolepsy and related neurological disorders.

The preclinical study is being conducted at the Centre for Neurological Research of Lyon(France), a world-class institution specializing in sleep and neurological research, and aims to evaluate the potential superiority of AEX compounds over existing therapies in the space by using an internationally validated orexin knockout (ORX-KO) mouse model of narcolepsy.While existing selective OX2R agonists have demonstrated efficacy in managing narcolepsy symptoms, DOXA are expected to surpass these benchmarks. By engaging both OX1R and OX2R receptors and addressing broader neurological pathways, AEX-41 and AEX-2 offer the potential for enhanced therapeutic outcomes, including greater wakefulness stability and improved sleep quality under real-world conditions.

Earlier in December, we shared preliminary results from this ongoing study of AEX-41 in narcolepsy models which suggested that the compound shows promise as a therapeutic agent for managing narcolepsy-related sleep-wake disturbances.

Key findings from the study included:

Wakefulness: Increased stability with fewer interruptions.
Slow-Wave Sleep (SWS): Reduced fragmentation and improved continuity.
REM Sleep: Significant reduction in pathological episodes.

Final top line results from the ongoing study are expected to be shared by the end of this year. In addition, the Company’s broader development plans include exploring the application of its DOXA platform also in other neurodegenerative conditions, such as Amyotrophic Lateral Sclerosis (ALS).

Overcoming Obstacles

Despite significant challenges over the past few months, we have successfully positioned NLS for the next phase of growth:

– Financial growth and Nasdaq Compliance: After a period of risk regarding our Nasdaq listing, we are pleased to have regained full compliance with all Nasdaq continued listing requirements. This achievement was a result of our successful efforts to improve our balance sheet, including settlement agreements with vendors and successfully fundraising from private as well as institutional investors. Full compliance allows us, and eventually the combined company, continued access and exposure to the U.S. capital markets.

– Financial Restructuring: In addition, we have made important strides in eliminating all debt and strengthening our balance sheet. In October 2024, we closed a $3.2 million private placement and in December we announced a second private placement raising up to $1 million at a price of $3.10, representing a 15% premium to the market, subject to certain closing conditions including shareholder approval. The two private placements together (if closed), with our existing cash position, extends our runway to approximately 18 months. This new influx of capital also gives us flexibility to execute our strategy including the development of the DOXA compounds and complete the merger process smoothly.

Merger with Kadimastem Ltd.

In addition to solving our listing and financial challenges, we also announced a potential merger with Kadimastem, a company we believe offers compelling strategic benefits, not only for the combined company but also for our shareholders. Kadimastem’s expertise in the development of innovative cell-based therapies will allow the DOXA program to thrive, and once the merger is finalized, these programs will become part of the merged company’s broader pipeline of neurodegenerative and diabetes candidates.

While Kadimastem will assume ownership of the active pipeline assets, including the DOXA program, NLS shareholders will retain an exclusive opportunity to benefit financially from the potential sale of our legacy assets, including Mazindol, through the contingent value rights (CVR) agreement associated with the merger.

Mazindol, which has long been part of our portfolio, is a key asset that received significant attention from private companies and therefore we believe holds significant potential for future value generation post-merger. We remain committed to maximizing this opportunity.

Looking Ahead: A Focused Strategy on Value Creation

The recent months have been a time of great challenge and achievement for NLS. As the merger is expected to close by the end of January 2025 and the integration process begins, we remain grateful for your continued support. We are committed to maximizing shareholder value through the potential sale of our legacy assets in the CVR and the combined company’s strengthened neurodegenerative and diabetes focused advanced clinical pipeline. With this strategy in place, we look forward to a future that is focused on value creation and the success of the DOXA program under Kadimastem’s leadership.

Thank you for your ongoing support as we move forward with this exciting next chapter.

Sincerely,

Alex Zwyer, CEO

About NLS Pharmaceutics Ltd.

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PIPELINE

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.

AstroRx, the medical product for ALS treatment that is being researched by Kadimastem, the company NLSP has signed a binding merger agreement with, was granted Orphan drug status by the FDA. This status grants the company that manufactures the drug marketing exclusivity for 7 years from the date of receipt of marketing approval of the drug. The recognition of orphan drug status also enables accelerated examination and response paths from the FDA and other regulatory authorities.
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Additionally, Kadimastem is focused on the generation and manufacturing of pancreatic insulin secreting islets (IsletRx) from embryonic stem cells for the treatment of insulin dependent diabetes such as Type 1 Diabetes. This program is in pre-clinical phase and they are moving fast down the regulatory path to start human trials. The number of patients with diabetes was estimated to be over 366 million worldwide in 2011 and is projected to be more than 552 million in 2030. The American Diabetes Association (ADA) estimated the total annual costs of diabetes to be US$223.5 billion (in the US alone). The global cost is estimated to be US$465 billion annually and will grow to about US$510 billion by 2030.

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MANAGEMENT TEAM

AlexZwyer, MBA

Chief Executive Officer & Co-Founder

A co-founder of the company with extensive operational, C-level pharmaceutical experience as well as a serial entrepreneur and strong leader with a proven track-record.

Alex Zwyer has served as our Chief Executive Officer and as a Director since our incorporation in August 2015. Mr. Zwyer has over 25 years of international business experience of which more than 10 years as a C-level executive in the pharma/biotech field. In 2007, prior to, and until founding NLS in 2015, Mr. Zwyer founded a startup in the high-end luxury food sector, and served as its chief executive officer until 2015 when he successfully sold the company. From 1991 and until 2007, Mr. Zwyer served in various positions with Viforpharma AG (SWX: VIFN) (then known as Vifor (International) Inc.), most notably serving as Executive Vice President (chief operating officer), leading the company’s global regulatory affairs, medical affairs, sales and marketing as well as business development teams. Mr. Zwyer speaks seven languages fluently. Mr. Zwyer holds a B.B.A. in business administration from Oekral, Zurich, Switzerland and an executive M.B.A. from GSBA/Lorange Institute of Business, Zurich, Switzerland and an M.B.A. from University at Albany SUNY.

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GeorgeApostol, MD MS

CMO & Global Head R&D

Dr. Apostol’s career spans more than 20 years in pharma industry and consists of a 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.

His main areas of capability include orphan diseases in CNS, in particular Fragile X Syndrome, Alagille Syndrome, but also ADHD, anxiety, depression, migraine, Parkinson’s and schizophrenia. He has built multiple drug development teams both in the US and Europe, several receiving distinguished corporate R&D awards and achieving multiple regulatory approvals in US, EU and Japan. He holds a MD degree from the Carol Davila Medical School in Romania and a MS in Clinical Research from University of Minnesota.

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EricKonofal, MD, PhD

Chief Scientific Officer and Co-Founder

A co-founder of the company with a deep knowledge and experience in clinical and scientific research. He is also a drug-hunter & pipeline developer for sleep disorders as ADHD.

Dr. Konofal is a primary clinical and international scientific researcher, and is an accomplished drug hunter and drug pipeline developer. He is a senior medical consultant for the Pediatric Sleep Disorders Center at Robert-Debre University of Paris (APHP). Dr. Konofal served as Principal Clinical Investigator at the Clinical Pharmacology & Pharmacogenetic Department at Robert-Debre University of Paris. His research has focused on brain- and iron-dopamine interactions in subjects with neurological sleep disorders (RLS, PLMS), and ADHD. Additionally, Dr. Konofal served as a consultant at the sleep disorder center of Pitié-Salpêtrière University Hospital Group (APHP), specializing in ADHD, RLS, PLMS and CDH. He initiated previous studies based on iron and its role in the pathophysiology of ADHD, and has conducted extensive research on the relationship between the brain and iron.

He launched a clinical trial on the efficacy of mazindol in children with ADHD (clinicaltrials.gov identifier: NCT00508677) and obtained the U.S. patent for mazindol in the treatment of ADHD. Dr. Konofal wrote the scientific rationale for Nolazol® and discovered the pharmacological profile of mazindol and its orexin-2 receptor binding properties. He has authored over 70 peer-reviewed publications in the area of sleep disorders and other CNS diseases.

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ElenaThyen-Pighin

Chief Financial Officer

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Ms. Thyen-Pighin holds extensive experience in leadership and management functions as both head of finance and human resources across a number of industries. Based in Switzerland, Ms. Thyen-Pighin has a successful track record, most notably in accounting for both private and publicly listed enterprises.

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NEWS

SINCERELY,

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