NITO Achieved Positive Results of Over 22% improvement in Reduction of N2O Emissions in Open Greenhouse Environment
N2OFF: Save Foods Received first order from a Peruvian Customer for its Eco-Friendly Solution for Fruits and Vegetables
NITO recently announced an incredible study result that “exceeded expectations” — a 54% reduction in N2O emissions in wheat crops in a greenhouse setting
This may explain why we saw NITO explode roughly 100% the last time we profiled the company back in May.
When we brought it to your attention last time is saw an average trade on the session of .64. After gapping up and opening at .75 the very next session, NITO exploded quickly to 1.30 before pulling back for roughly a 100% Move overnight.
Let’s take a look at the company again and research it immediately.
Post-harvest treatment of fruits and vegetables plays a critical role in maintaining their quality, extending shelf life, and reducing losses during storage, transportation, and distribution.
By implementing these certain treatments and management practices, producers and distributors can minimize losses, maintain product quality, and deliver fresh and nutritious fruits and vegetables to consumers worldwide.
N2OFF Inc. (formerly known as Save Foods, Inc.) is an innovative agri-food tech company that through its two operational arms delivers integrated solutions for improved safety, quality, and sustainability every step of the way from field to fork.
Save Foods Ltd., N2OFF’s 98% majority-owned subsidiary, Save Foods Ltd. focuses on post- and near-harvest treatments for fruits and vegetables to prevent contamination and extend shelf lifemajority-owned Israeli subsidiary, focuses on post-harvest treatments in fruit and vegetables to control and prevent pathogen contamination, significantly reduce the use of hazardous chemicals, and prolong fresh produce’s shelf life. NTWO OFF Ltd., N2OFF’s majority-owned Israeli subsidiary, contributes to tackling greenhouse gas emissions, offering a pioneering solution to mitigate emissions of nitrous oxide (N2O), a potent greenhouse gas with 265 times the global warming impact of carbon dioxide. NTWO OFF Ltd. aims to promote agricultural practices that are both environmentally friendly and economically viable. NITO is at the forefront of pioneering an innovative solution for farmers and fertilizer companies striving to reduce their environmental footprint.
With nine issued patents and six pending applications, Save Foods Ltd. recently gained approval from the California Department of Pesticide Regulation for its FieldProtect pre-harvest treatment. This approval opens doors for commercial expansion in California, where their previous trials on strawberries showed an 85% reduction in waste compared to industry standards.
NITO has also established a presence in Brazil, collaborating with Citrus Tree to treat over 20 tons of Tahiti limes.
NITO has A 60% majority-owned subsidiary, N2OFF Ltd. specializes in reducing nitrous oxide (N2O) emissions in agriculture. N2O is a potent greenhouse gas, about 300 times more powerful than carbon dioxide, significantly contributing to ozone layer depletion.
Understanding the necessity of mitigating harmful environmental impacts, they’ve developed a natural technology specifically tailored to significantly decrease nitrous oxide emissions in wheat crops. Their environmentally friendly solution is easy to apply and holds the promise of a cleaner future for all.
Their innovative technology is specifically designed to tackle nitrous oxide emissions in agriculture.
Through a pilot study in wheat crops, they have achieved significant reductions. Scaling our findings to larger fields, we aim to demonstrate substantial emission reductions and empower farmers and fertilizer companies to join the solution. They created N2OFF so the ozone could heal, agriculture could thrive, and a green world could bloom.
They understand the importance of reducing our N2O emissions without sacrificing crop yields or quality. That’s why they’ve developed a natural technology that significantly reduces nitrous oxide emissions in wheat crops. By adopting their solution, farmers and seed fertilizer companies will be able to unlock a valuable new revenue stream while contributing to a greener future.
�N2OFF Ltd. introduces two natural, plant-safe, and non-GMO bacteria strains into the soil to reduce N2O emissions. Recent studies showed a 54% reduction in N2O emissions in wheat crops in a greenhouse setting, marking a significant breakthrough.
� The company is expanding its innovative bacterial technology to corn, a crucial crop as the U.S. produces about one-third of the world’s corn. Plans are underway to implement and evaluate these solutions on a large-scale wheat farm.
N2OFF INC. Enters the Growing Solar PV Market and signs an Agreement with a Company of Seasoned Experts in the Field
The global solar photovoltaic (PV) market was estimated at USD 150 billion in 2022 and is predicted to hit over USD 383.78 billion by 2032
Neve Yarak, Israel, July 22, 2024 (GLOBE NEWSWIRE) — N2OFF, Inc.\ (NASDAQ: NITO) (FSE:80W) (“N2OFF”, or the “Company”), a clean- tech company offering sustainable solutions for various industries, announced today the expansion to the solar PV (photovoltaic) market, potentially proving investors lucrative assets alongside its innovation for the agri- tech market.
N2OFF partnered with Solterra Renewable Energy Ltd. (“Solterra”), a company founded in 2022 by Eran Litvak and Yair Harel, in the field of solar PV systems. Each of the founders is an expert in the field of solar PV, with a track record of dozens of successful projects. In addition, both are experienced entrepreneurs and managers with over 20 years of proven experience in identifying business opportunities, enhancing projects, and maximizing value in both the energy and financial sectors.
Solterra is currently active in three primary target markets: Italy, Poland, and Germany, managing a portfolio of at various stages of Solar PV development with a total cumulative capacity of approximately 300 megawatts.
“In recent months, we focused on the development of our subsidiary, NTWO OFF Ltd., which aims to reduce N₂O emissions using innovative bacterial technology for agriculture. In parallel, we identified what we believe is an attractive opportunity in the growing solar PV market. Our decision to enter this field was primarily driven by our collaboration with the experts from Solterra, who have experience in leading solar PV projects. The current loan agreement marks the beginning of a collaboration we believe could have great potential for profitability and revenue generation in future projects” David Palach, Chief Executive Officer of N2OFF.
According to Precedence Research, the global solar PV market was estimated at $150 billion in 2022 and is predicted to hit over $383.78 billion by 2032 and poised to grow at a CAGR of 9.90% during the forecast period from 2023 to 2032.
N2OFF entered into a loan agreement with Solterra and certain other private investors pursuant to which they committed to loan Solterra an aggregate of €500,000, of which €375,000 was committed by the Company.
NTWO OFF Achieved Positive Results of Over 22% improvement in Reduction of N2O Emissions in Open Greenhouse Environment
Recent greenhouse study resulted in a reduction of emissions of up to 54% compared to a previous study reduction of up to 44%
Neve Yarak, Israel, May 09, 2024 (GLOBE NEWSWIRE) — N2OFF, Inc.\ (NASDAQ: NITO) (FSE:80W) (“N2OFF” or the “Company”), a pioneering agri-food tech company offering sustainable solutions for agriculture and plant-based food, announced that its subsidiary NTWO OFF Ltd., has achieved a groundbreaking milestone in its mission to mitigate agriculture’s environmental impact. A recent study conducted by NTWO OFF Ltd.’s research team has demonstrated remarkable success in its goal of reducing nitrous oxide (N2O) emissions from wheat crops.
The study transitioned from growth chambers to open greenhouse environments, allowing for larger pots and soil volumes. This adaptation facilitated the cultivation of more plants per pot and extended growth periods. The results exceeded expectations, with N2O emissions reduced by up to 54% compared to NTWO OFF Ltd.’s previous study result of emissions reduced by up to 44%, representing more than 22% improvement.
“We are thrilled by the outstanding performance of our innovative bacteria under open greenhouse conditions. The successful transition from the lab to an open greenhouse environment is a leap forward in our efforts to develop solutions for the reduction of N20 emissions in agriculture” said Dr. Dror Minz, of the ARO Volcani Institute and head of the research team.
NTWO OFF Ltd.’s proprietary technology revolves around two naturally occurring bacteria species isolated from wheat roots. These bacteria have demonstrated the ability to reduce N2O emissions across various environmental conditions. NTWO OFF Ltd. rigorously tests different formulations and soil types to optimize the effectiveness of this technology.
“Our commitment to environmental stewardship drives every aspect of our development. As the global community grapples with the challenges of climate change, NTWO OFF Ltd. remains steadfast in our dedication to providing innovative solutions for sustainable agriculture,” said David Palach, chief executive officer of N2OFF Inc.
According to Our World in Data, Nitrous oxide, often dubbed the “forgotten greenhouse gas”, poses a significant threat to the environment, being 265 times more potent than carbon dioxide in warming the planet. By pioneering solutions to mitigate N2O emissions, NTWO OFF Ltd. aims to play a pivotal role in combating climate change and promoting environmental sustainability.
Following the promising results achieved in its greenhouse experiments, NTWO OFF Ltd. is poised to expand its research efforts. Plans are underway to conduct larger-scale experiments in significantly larger containers, filled with various soil types. These endeavors aim to further validate the efficacy of NTWO OFF Ltd.’s technology across diverse agricultural settings.
N2OFF: Save Foods Received first order from a Peruvian Customer for its Eco-Friendly Solution for Fruits and Vegetables
Neve Yarak, Israel, May 01, 2024 (GLOBE NEWSWIRE) — N2OFF, Inc.\ (NASDAQ: NITO) (FSE:80W) (“N2OFF” or the “Company”), a pioneer agri-food tech company offering sustainable solutions for agriculture and plant-based food, announced today that its subsidiary Save Foods Ltd. received its first purchase order from a customer in Peru, a leading grower, packer and distributor of avocado.
Save Foods’ eco- friendly solutions can be applied as a near and post-harvest solution for fresh produce to control pathogen contamination and prolong the shelf life of fresh produce while reducing the use of hazardous chemicals.
David Palach, Chief Executive Officer of N2OFF Inc. commented “During the last few years our customer conducted several post-harvest pilots where hundreds of tons of avocado were protected with Save Foods’ solutions. The purchase order from the Peruvian customer was received after the success of Save Food’s first commercial implementation of its solution during January 2024.
Mr. Palach added: The Latin American market represents a tremendous opportunity for Save Foods. With many countries in the region at the forefront of the global fresh produce market, we believe our products hold immense potential, whether utilized post-or near harvest. Our first order from Peru is particularly exhilarating, given the remarkable growth of Peruvian agricultural exports on the global stage, from a modest $645 million in 2000 to an impressive estimated $10.5 billion in 2023.”
N2OFF: Save Foods’ Innovative Technology Secures Patent Approval in South Africa, Strengthening Global Food Safety Efforts
In 2022, South Africa exported $1.85 billion in citrus, making it the second largest exporter of citrus in the world
Neve Yarak, Israel, May 28, 2024 (GLOBE NEWSWIRE) — N2OFF, Inc. (NASDAQ: NITO) (FSE:80W) (“N2OFF” or the “Company”), a pioneer agri-food tech company offering sustainable solutions for agriculture and plant-based food, as previously announced on March 28, 2024, one of Save Foods Ltd.’s patents has been granted in South Africa. This achievement emphasizes the Company’s ongoing commitment to global food safety and sustainability while expanding its geographical distribution.
The newly granted patent, “Sterilization Compositions and Methods for Use Thereof”, refers to kits and methods for controlling pathogen load within or on the surface of edible plant matter.
According to The Observatory of Economic Complexity, in 2022 South Africa exported $1.85 billion in citrus, making it the second largest exporter of citrus in the world. Concurrently, in 2022, citrus represented the 14th
N2OFF: Save Foods Granted Patent Approval in South Africa for its Proprietary Technology https://t.co/VWYm5NVUWN
Meet Shmuel, a dynamic economist with a passion for cutting-edge technologies, entrepreneurship, and investment banking.
With experience as Director and Chief of Investment Banking at the American Yorkville Foundation, he brings a wealth of expertise to the table.
Shmuel holds a BA degree in Economics and an LL.B. degree in Laws from Hebrew University in Jerusalem, fueling his drive for innovation and success.
Shmuel holds an Israeli Bar license as Israeli lawyer.
Shlomo Zakai
CFO
Presently, Shlomo Zakai holds the position of Chief Financial Officer & Treasurer at Global Energy, Inc., Chief Financial Officer of UAS Drone Corp., Chief Financial Officer at Cuentas, Inc., Internal Auditor of F.M.S.
Enterprises Migun Ltd., Internal Auditor of Payton Industries Ltd. and Chief Financial Officer of Save Foods Ltd.
Shlomo Zakai previously occupied the position of Financial Controller at N2OFF, Inc., Chief Financial Officer for Sonovia Ltd., Co-Chief Financial Officer-Israel & Treasurer at Blue Sphere Corp., Chief Financial Officer for Todos Medical Ltd., Senior Manager at Ernst & Young Global Ltd. and Accountant for Kost Forer Gabbay & Kasierer (a subsidiary of Ernst & Young Global Ltd.), Internal Auditor for Alarum Technologies Ltd. and Internal Auditor of Ralco Agencies Ltd.
Mr. Zakai received an undergraduate degree from The College of Management Academic Studies
Dr. Dror Minz
Head of Research Team
With a strong academic background, Dror is a distinguished researcher and educator in the field of environmental sciences. He completed his studies at Tel Aviv University before pursuing postdoctoral research at Northwestern University in Evanston, IL, and the Max Planck Institute in Bremen, Germany.
Currently serving as a researcher at the Institute for Soil, Water, and Environmental Sciences, he also imparts his knowledge as a teacher at the Hebrew University.
Dror has made significant contributions to the field, having supervised 23 MSc and PhD students, mentored 11 postdoctoral fellows, and authored over 100 scientific papers.
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SYNX Has Received Roughly $4 Million in Orders from the IDF & Israeli Police Since the Start of the War
The company has estimated revenues for the six months ended June 30, 2024 to be approximately $5.31 million, highlighting tremendous growth
Silynxcom Secures Multiple Orders from US Federal and Law Enforcement Organizations of its New Tactical System
Revenues for the year ended December 31, 2023 increased to $7.6 million, up 5% from the previous year, reflecting the Company’s ongoing expansion and product adoption
Preliminary unaudited revenue for the three months ended March 31, 2024, that is estimated at $3.525 million, representing an estimated increase of more than 100% compared to the same period in 2023
We have another company for youth research for Thursday’s session.
It has been a little bit since we last took a look at a defense company. We love this sector and are always excited to put an undiscovered company on your plate so that you can research it.
Pull up SYNX Immediately.
The company put out some substantial news today that you can read down below. The news had major impact, sending SYNX exploding double digits and almost breaching the 4 buck level.
SYNX has a great story behind it.
Since it’s inception, the company has achieved over $150M in revenue from iconic government defense institutions like the CIA, U.S. Army and Marine Corps.
It is estimated that roughly 17% of returning veterans suffer from some form of hearing loss.
Just in March, 250,000 vets reached a $6 billion settlement of a class-action lawsuit alleging popular earplugs used in the Iraq and Afghanistan wars were faulty.
The products are compatible with most radios, smartphones, and intercom systems, including encrypted channels used by tactical and law enforcement units.
Silynx headsets are used by elite US and international warfighters, all levels of law enforcement, including federal, state, and local, and international public safety and security forces. Silynx headset systems protect against impulse and steady-state noises while enabling the user to hear ambient noises, via “hear-thru” functionality, and maintain 360° situational awareness.
Working closely with end users, Silynx integrates feedback from the field into all of its solutions. Compatible with standard military and law enforcement radios and available with a broad range of unique accessories, Silynx headsets can be used in any mission setting, mounted/dismounted, maritime, airborne, or low-vis operations. Silynx solutions provide users with an unparalleled operational edge. Silynx is committed to constant innovation and improvement of products and ideas to meet the continually changing requirements of operators.
Silynxcom Receives New Order Further Expanding Presence in Military Tactical Communication Equipment Market
The tactical sound protection headset market is projectedto reach $3.8 Billion by 2027
Company received accumulated orders of approximately $815,000 from the Israel Defense Forces since the beginning of July 2024
Netanya, Israel, July 24, 2024 (GLOBE NEWSWIRE) — Silynxcom Ltd. (NYSE American: SYNX) (“Silynxcom” or the “Company”), a manufacturer and developer of ruggedized tactical communication headset devices has received an additional order from the Israel Defense Forces (“IDF”) for its advanced tactical communication headset devices. This latest order for $315,000 comes after a $500,000 order (both amounts approximate based on current exchange rates) from the IDF was announced by the Company on July 9, 2024. The Company also recently announced on July 9, 2024, a strong performance for the first half of 2024 on a preliminary unaudited basis, including estimated revenue for the six months ended June 30, 2024 of approximately $5.31 million – highlighting accelerated operational and business growth – and cash and cash equivalents and marketable securities of approximately $3.69 million as of June 30, 2024.
Nir Klein, Chief Executive Officer of Silynxcom, said “We are proud to report another order for our advanced tactical communication headset devices from the IDF. We are excited about the opportunity to continue scaling up our revenue growth into our addressable market that is estimated to reach $3.8 billion by 2027 according to the Global Tactical Headset Market Research Report, published by Wantstats Research and Media Pvt Ltd.”
Silynxcom’s tactical communication headset devices are designed to meet the rigorous demands of modern militaries, law enforcement units and industrial and commercial plants.Silynxcom’s products ensure more efficient and safer high-quality audio, clarity and robust communication.
The above preliminary financial information is based upon the Company’s estimates and is subject to completion of its financial closing procedures. Moreover, this preliminary financial information has been prepared solely on the basis of information that is currently available to, and that is the responsibility of, management. The Company’s independent registered public accounting firm has not audited nor reviewed, and does not express an opinion with respect to, this information. This preliminary financial information is not a comprehensive statement of the Company’s revenue and cash and cash equivalents for the six months ended June 30, 2024 and remains subject to, among other things, the completion of the Company’s financial closing procedures, final adjustments, and completion of its internal review for the six months ended June 30, 2024, which may materially impact the results and expectations set forth above. As a result, this preliminary unaudited financial information may differ from the actual results that will be reflected in the Company’s results of operations and financial position as of and for the six months ended June 30, 2024 when they are completed and publicly disclosed. This preliminary unaudited financial information may change. Accordingly, you should not place undue reliance upon these preliminary unaudited estimates.
Silynxcom Secures Multiple Orders from US Federal and Law Enforcement Organizations of its New Tactical System
Netanya, Israel, June 18, 2024 (GLOBE NEWSWIRE) — Silynxcom Ltd. (NYSE American: SYNX) (“Silynxcom” or the “Company”), a manufacturer and developer of ruggedized tactical communication headset devices as well as other communication accessories, announced that its latest tactical communication system is gaining traction in the U.S. market. Multiple law enforcement and federal organizations have placed orders for the new system, which the Company believes highlights the product’s effectiveness and reliability.
The new In-Ear Headset system, designed to meet the unique requirements of law enforcement and public safety organizations, represents a major innovation in secure and encrypted communication. Compatible with “Project 25 (P25)” and “TETRA”- Terrestrial Trunked Radio communication systems, widely used across the globe, the system ensures seamless integration and superior performance.
Highlights:
Innovative Product Launch: Silynxcom’s latest offering taps into the massive law enforcement communication market, showcasing the Company’s commitment to innovation and its ability to develop products that meet critical market needs.
First-Mover Advantage: With this new system, Silynxcom secures a first-mover advantage in providing high-quality, encrypted communication solutions for law enforcement agencies, offering significant growth potential within the sector.
Market Expansion: These orders pave the way for Silynxcom to expand its footprint globally, particularly in the lucrative European law enforcement market. The Company is strategically positioned to capitalize on new opportunities, aiming to broaden its reach and penetrate new segments within the government sector.
Product Differentiation: The In-Ear Headset system sets a new industry standard with features like superior audio quality, compatibility with a wide range of radio devices, and seamless integration into law enforcement workflows. This differentiation strengthens Silynxcom’s competitive edge and market positioning.
Silynxcom Announces Annual Results for 2023; Positive Cash Flow and Revenue Growth
NETANYA, Israel, April 30, 2024 (GLOBE NEWSWIRE) — Silynxcom Ltd. (NYSE American: SYNX) (“Silynxcom” or the “Company”), a manufacturer and developer of ruggedized tactical communication headset devices as well as other communication accessories, has released its consolidated financial results for the full year period ended December 31, 2023. The Company has filed its Annual Report on Form 20-F for the year ended December 31, 2023 (the “Annual Report”) with the U.S. Securities and Exchange Commission (“SEC”), which can be accessed on its website at https://www.silynxcom.com/. Shareholders may request, free of charge, a hard copy of the Annual Report, which includes Silynxcom’s complete audited consolidated financial statements for the year ended December 31, 2023, by contacting ir@silynxcom.com.
Key Financial Highlights for 2023:
Cash and Cash Equivalents- On January 12, 2024, Silynxcom successfully completed its initial public offering (“IPO”), raising $5 million by issuing 1.25 million ordinary shares, adding to a year-end cash balance of $568 thousand, up from $69 thousand in the previous year, demonstrating strong liquidity to support ongoing investments and operations.
Positive Cash Flow from operating activities amounted to $730 thousand, compared to cash flow used in operating activities of $1.7 million in 2022.
Operating loss Operating loss for 2023 was $2.8 million, compared to an operating profit of $480 thousand in 2022, reflecting heightened investments in R&D and market expansion efforts. Non-IFRS operating profit amounted to $1.4 million, representing an increase of more than 200% compared to $480 thousand in 2022. A reconciliation between operating profit (loss) and non-IFRS operating profit (loss) is provided in Appendix A to this press release.
Net loss Net loss for the year ended December 31, 2023 was $2.8 million, compared to a net income of $1.8 million in 2022 that included $1.2 million in finance income from warrant buybacks. Non-IFRS net income for the year ended 2023 totaled $1.3 million, representing growth of more than 150% year over year compared to $561 thousand in 2022. A reconciliation between net income (loss) and non-IFRS net income is provided in Appendix A to this press release.
Revenues for the year ended December 31, 2023 increased to $7.6 million, up 5% from the previous year. This growth reflects the Company’s ongoing expansion and product adoption.
“2023 was a year of business expansion, growth and strategic investment for Silynxcom, followed by becoming a listed company on the NYSE following a successful IPO in January 2024,” said Nir Klein, Chief Executive Officer of Silynxcom. “Our revenue increased alongside becoming cashflow positive, which we believe underscores our successful market expansion and enhanced financial stability.”
“In 2023, we laid the foundation for new and advanced products and increased compatibility for leading systems in our target markets. In addition, we forged new partnerships with key players in the global defense and law enforcement sectors, which already led to purchase orders in 2024,” added Mr. Klein.
Recent Corporate Highlights:
In April 2024, the Company announced the strengthening of its collaboration with 3M PELTOR to deliver next generation headset solutions.
The Company entered new markets in East Asia and Asia Pacific.
Since October 2023, the Company has secured orders exceeding $4.85 millionfrom one Israel Defense Forces and Israeli police forces.
In February 2024, the Company disclosed a third order from a leading global defense firm, bringing its total orders from this client to over $4.5 million.
The Company received its first order for the newly designed in-ear headset with an encrypted security system intended for use by law enforcement.
In March 2014, the Company launched a new system for law enforcement, compatible with commonly used terrestrial trunked radio (“TETRA”) and P25 systems.
Use of Non-IFRS Financial Results
In addition to disclosing financial results calculated in accordance with International Financial Reporting Standards (“IFRS”) as issued by the International Accounting Standards Board, this press release contains certain financial measures that are not prepared under IFRS. These measures may be different from non-IFRS financial measures used by other companies. The Company defines non-IFRS operating profit (loss) as operating profit (loss) excluding the effect of share-based compensation expenses. The Company defines non-IFRS net income as net income (loss) excluding the effect of share-based compensation expenses and the revaluation of a liability in respect of warrants. The Company’s management believes the non-IFRS financial information provided in this press release is useful to investors’ understanding and assessment of the Company’s ongoing operations. Management also uses both IFRS and non-IFRS information in evaluating and operating business internally and as such deemed it important to provide all this information to investors. The non-IFRS financial measures disclosed by the Company should not be considered in isolation or as a substitute for, or superior to, financial measures calculated in accordance with IFRS and the financial results calculated in accordance with IFRS and reconciliations to those financial statements should be carefully evaluated. Reconciliations between IFRS measures and non-IFRS measures are provided in Appendix A to this press release.
Silynxcom Estimates Revenue Growth of More Than 100% for the First Quarter of 2024
Netanya, Israel, May 13, 2024 (GLOBE NEWSWIRE) — Silynxcom Ltd. (NYSE American: SYNX) (“Silynxcom” or the “Company”), a manufacturer and developer of ruggedized tactical communication headset devices as well as other communication accessories, today provided preliminary unaudited financial results as of and for the three months ended March 31, 2024.
On a preliminary unaudited basis, Silynxcom is reporting a strong performance for the first quarter of 2024, highlighting accelerated operational and business growth including:
preliminary unaudited revenue for the three months ended March 31, 2024, that is estimated at $3.525 million, representing an estimated increase of more than 100% compared to the same period in 2023; and
preliminary unaudited cash and cash equivalents as of March 31, 2024, that amounted to $4.353 million.
“We are proud to report remarkable preliminary results, marked by significant revenue growth. This success has been fueled by our expansion in our marketing efforts, our customer base and our new innovative products. Recent geopolitical events strengthen demand for effective and safe solutions for tactical communication, increasing global awareness of our advanced capabilities,” said Nir Klein, Silynxcom’s Chief Executive Officer.
The above figures represent preliminary unaudited estimates and final quarterly reporting results may vary. The preliminary unaudited results presented reflect the Company’s estimates based solely upon information available and the Company’s final results may differ from these preliminary estimates due to the completion of the Company’s financial closing procedures, final adjustments and other developments that may arise between now and the time such final unaudited financial information is issued. The foregoing forward-looking statements reflect the Company’s expectations as of today’s date.
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As of December 31, 2023 NNVC had cash and cash equivalent current assets balance of approximately $5.31 Million
This Innovative Biotech Company Is Taking A Novel, Game-Changing Approach To Eradicating Many Respiratory Viruses Once And For All Including Tripledemic Threat Of COVID, RSV, FLU…
ANTIBODIES AND VACCINES ARE OUTDATED: NanoViricides, Inc has a more innovative approach that works even when viruses mutate
We have a new profile that we want you to put back on your radar for Wednesday’s session.
You are definitely going to remember this one.
This is a company we showed you back in May when it was well under 2 bucks. Then we looked at it again in early June when it was under 2.50 and went on to hit 3.60 just a few sessions later for at quick 40%+ move.
It is on the run again, closing green 5 of the last 6 sessions.
NanoViricides, Inc. (NYSE American: NNVC) looks well-positioned to be a market disruptor with nontoxic, effective antiviral therapies based on patented nanomedicine technology.
NanoViricides, Inc. (NYSE American: NNVC) is a global leader in the application of nanomedicine technologies to the safe and effective treatment of viruses and their variants INCLUDING drugs against Covid-19, RSV and other respiratory viruses!
Even with a decline since 2022, COVID-19 continues to hospitalize and kill people in the USA – the CDC website states 69,200 hospitalizations and 2,652 deaths since January 1, 2024; the worldwide market size for COVID-19 therapeutics is expected to exceed $16.2 Billion in 2031.
NANOVIRICIDES are better because they destroy viruses and their variants without relying on the patient’s immune system, thereby making them effective for populations that include geriatric and pediatric patients.
Antibodies only bind by two points to the virus, and destruction of the complex requires effective immune function, which is not the case in sick patients..
Vaccines only train the body into producing antibodies against the virus in the vaccine. Antibodies and vaccines are easily overcome by viruses by mutating in the field, hence the need for annual influenza vaccine updates.
NNVC is a development stage company that is creating special purpose nanomaterials for antiviral therapy. The Company’s novel nanoviricide® class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. Our lead drug candidate is NV-CoV-2 for the treatment of COVID-19 disease caused by SARS-CoV-2 coronavirus. Our other advanced candidate is NV-HHV-1 for the treatment of Shingles (previously referred to as NV-HHV-101). The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants. The Company is currently focused on advancing NV-CoV-2 into Phase I/II human clinical trials. NV-CoV-2 is our nanoviricide drug candidate for COVID-19 that does not encapsulate remdesivir. NV-CoV-2-R is our other drug candidate for COVID-19 that is made up of NV-CoV-2 with remdesivir encapsulated within its polymeric micelles. The Company believes that since remdesivir is already US FDA approved, our drug candidate encapsulating remdesivir is likely to be an approvable drug, if safety is comparable. Remdesivir is developed by Gilead. The Company has developed both of its own drug candidates NV-CoV-2 and NV-CoV-2-R independently. The Company is also developing drugs against a number of viral diseases including oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. NanoViricides’ platform technology and programs are based on the TheraCour® nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms in perpetuity for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for poxviruses and/or enteroviruses if the initial research is successful. The Company’s technology is based on broad, exclusive, sub-licensable, field licenses to drugs developed in these areas from TheraCour Pharma, Inc. The Company’s business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005.
RECENT COMPANY HIGHLIGHTS:
NanoViricides, Inc’s lead drug, NV-387, is in Phase 1 clinical trials.
Broad spectrum antiviral NV-387 showing promise against many virus families including and beyond Tripledemic (i.e. COVID-19, RSV, FLU) .
No adverse events in Phase I SAD and MAD studies even at the highest dose 40mg/Kg
Found to be non-immunogenic, non-mutagenic, non-allergenic, and non-phototoxic.
Strong safety allows use in pediatrics, adults with co-morbidities, and immune-compromised patients unlike limitations of products currently in the market.
Developed Oral Syrup and Oral Gummies (soft solids) – good for geriatric and pediatric patients
Drugs expected to continue to be effective even as the virus generates variants – unique receptor site doesn’t change
Technology mimics unique receptor site used by virus; delivers to specific targets using receptor-recognition (no bulky antibodies)
A New Era in Targeted Anti-Viral Therapeutics
NanoViricides, Inc. is a globally leading company in the application of nanomedicine technologies to the complex issues of viral diseases. The nanoviricide® technology enables direct attacks at multiple points on a virus particle. It is believed that such attacks would lead to the virus particle becoming ineffective at infecting cells. Antibodies in contrast attack a virus particle at only a maximum of two attachment points per antibody. In addition, the nanoviricide technology also simultaneously enables attacking the rapid intracellular reproduction of the virus by incorporating one or more active pharmaceutical ingredients (APIs) within the core of the nanoviricide. The nanoviricide technology is the only technology in the world, to the best of our knowledge, that is capable of both (a) attacking extracellular virus, thereby breaking the reinfection cycle, and simultaneously (b) disrupting intracellular production of the virus, thereby enabling complete control of a virus infection.
Our anti-viral therapeutics, that we call “nanoviricides®” are designed to appear to the virus like the native host cell surface to which it binds. Since these binding sites for a given virus do not change despite mutations and other changes in the virus, we believe that our drugs will be broad-spectrum, i.e. effective against most if not all strains, types, or subtypes, of a given virus, provided the virus-binding portion of the nanoviricide is engineered appropriately. Viruses would not be able to escape the nanoviricide by viral mutations since they continue to bind to the same cellular receptor and thus would be captured by the nanoviricide. Virus escape by mutations is a major problem in the treatment of viral diseases using conventional drugs.
Versatile Platform Technology
A nanoviricide is created by chemically attaching a virus-binding ligand, derived from the binding site of the virus on its cell surface receptor, to a nanomicelle flexible polymer. This binding site does not change significantly when a virus mutates
Tailor-made design and selection of (1) the virus-binding ligand; and (2) the backbone “nanomicelle”, separately, allows us to rapidly optimize drug candidates (a) against a number of viruses; (b) for desired pharmacokinetic characteristics (e.g. sustained effect); and (c) for different routes of administration. This versatility is unmatched in the Industry.
Virus-specific nanoviricides have been created against important viruses such as HIV, Influenza and Bird Flu by choosing highly virus-specific ligands
Broad-spectrum nanoviricides have been created that can bind to possibly as many as 90-95% of known viruses. The Company is developing broad-spectrum nanoviricides to combat several neglected tropical diseases, such as Dengue, Rabies, and Ebola/Marburg. This is similar to antibiotics such as penicillin against bacteria that exploit a feature common to all bacteria.
A NanoViricide® Attacking a Virus Particle: Unique, Novel, Nanotech Design
A single nanoviricide micelle may be capable of completely engulfing a Virus Particle. Nanoviricide micelles self-assemble from multiple chains. A single chain micelle shown for convenience. Illustration not to scale.
Each nanoviricide drug is designed as an antiviral agent specifically targeted for a particular type of virus or group of viruses. Most existing anti-viral agents are known to have non-specific effects against both host cells and viral machinery at the same time often leading to side effects. Most current anti-viral agents act inside human cells. It is believed that this intracellular mechanism leads to significant opportunities for unwanted side effects against host cells. Nanoviricides, on the other hand, are designed to work directly against virus particles in bodily fluids. The Company believes that this approach may make nanoviricides inherently safer than existing approaches.
A nanoviricide is designed to seek and attach to a specific virus particle, engulfing the virus particle in the process, thereby rendering it incapable of infecting new cells, and disabling it completely. This suggested mechanism of action encompasses much more than what the current entry and fusion inhibitors are expected to do. The fusion and entry inhibitors do not completely cover the virus particle, likely blocking only a few sites on the virus particle. This means the virus particle may still be capable of infecting cells using its unblocked attachment sites. In contrast, a nanoviricide, because of its larger size and flexible nature, is expected to engulf the virus particle completely, thus disabling the virus particle. The action of a nanoviricide, if it works as designed, may be expected to be superior to antibody agents that attack viruses. Antibodies, being large, are expected to block relatively greater portions of the virus particle surface compared to small molecule entry inhibitors. However, antibodies depend upon the human immune system responses for clearing the virus particle. In contrast, nanoviricides are thought to be capable of acting as completely programmed chemical robots that finish their task of destroying the virus particle on their own.
NV 387 IN CLINICAL TRIALS
The drug, developed in response to the COVID-19 pandemic, demonstrated exceptional safety in clinical trials, even at the highest dose levels, with NO adverse events reported. The unique mechanism of action involves mimicking a cell membrane, encapsulating and blocking the virus.
Beyond COVID-19, the drug also displayed promising results against respiratory syncytial virus (RSV), offering a potential solution for infants and seniors where existing treatments like ribavirin may be contraindicated due to side effects.
The clinical trials involved both oral tablets and oral gummies, catering to various age groups, including pediatrics. NV 387 exhibited broad-spectrum activity against multiple strains of coronaviruses, showcasing effectiveness 10 times greater than remdesivir in preclinical studies.
The ongoing clinical trial progress and positive results position NanoViricides at the forefront of antiviral drug development, marking a significant milestone in their journey from preclinical research since 2005 to clinical trials.
The company believes that NV-387 not only binds to the virus, but fuses with the virus surface, uprooting the glycoproteins that are required for the virus to bind to the human cell (for example, the S protein, and its products S1 and S2 proteins from coronaviruses), thereby rendering the virus incapable of infecting a cell. In contrast, antibodies are only capable of covering the virus, generally incompletely, and require immune system assistance for clearing the resulting complex!
NV-387 ADDRESSES AN UNMET MEDICAL NEED FOR BROAD-SPECTRUM, SAFE AND EFFECTIVE ANTIVIRAL DRUG THAT WORKS AGAINST MULTIPLE VIRAL THREATS:
There is a significant unmet medical need for a broad-spectrum antiviral drug that is effective and useable in all segments of the population. There are substantial limitations for all currently approved COVID drugs in terms of both the eligibility of a COVID patient, and the effectiveness of the drug.
NNVC believes that the excellent safety and the distinctly different mechanism of NV-CoV-2 (NV-387) support the use of this drug across all patient populations. This is an important characteristic for a COVID drug as well as for a drug to treat RSV infection.
NV-387 ADDRESSES LARGE MARKET SIZES:
Even with a decline since 2022, COVID-19 continues to hospitalize and kill people in the USA – the CDC website states 69,200 hospitalizations and 2,652 deaths since January 1, 2024; the worldwide market size for COVID-19 therapeutics is expected to exceed $16.2 Billion in 2031*.
*Source: Transparency Market Research
The market size for RSV therapeutics was estimated to be $2 Billion in 2023 and is expected to rise to exceed $8.5 Billion by the year 2031**.
**Source: Growth+ Market Reports.
NANOVIRICIDES TECHNOLOGY WILL TRANSFORM THE WAY VIRUSES & THEIR VARIANTS ARE TREATED WORLDWIDE!
NNVC’s novel approach has already enabled variant-proof drugs, blocking the complete viral life cycle without requiring help from the host’s defense systems! If both the viral re-infection cycle, and viral replication cycle arms of the viral lifecycle are blocked, a cure for many viral diseases is possible!!
The Company’s virus-specific nanoviricides have been created against important viruses such as HIV, Influenza and Bird Flu by choosing highly virus-specific ligands.
Broad-spectrum nanoviricides have been created that can bind to possibly as many as 90-95% of known viruses. The Company is also developing broad-spectrum nanoviricides to combat several neglected tropical diseases, such as Dengue, Rabies, and Ebola/Marburg.
A Novel Broad-Spectrum Antiviral with Activity Against Smallpox/Mpox – NV-387 Possesses Strong Orthopoxvirus Activity Relevant to Both Sexual and Inhalation Modes of Transmission, Says NanoViricides
SHELTON, CONNECTICUT – Wednesday, May 8, 2024 — NanoViricides, Inc. (NYSE Amer.: NNVC) (the “Company”), a global leader in broad-spectrum antiviral nanomedicines, says that the ultra-broad antiviral activity spectrum of NV-387 includes activity against orthopoxvirus family (Smallpox/Mpox), with both inhalation and skin abrasion (sexual) modes of infection acquisition. Ectromelia virus infection of mice is a model for Smallpox infection in humans, and also serves as a surrogate for MPox infection in humans. All three viruses belong to the orthopoxvirus family.
NanoViricides reports that in a lethal animal model of lung infection by Ectromelia virus, oral dosing with NV-387 led to an increase in lifespan of mice that was comparable to oral treatment with tecovirimat (TPOXX®, SIGA), the approved drug against Smallpox.
This lung infection study substantiates the results of the previously reported intradigital footpad infection study that: (i) NV-387 has comparable antiviral activity as tecovirimat, and (ii) NV-387 plus tecovirimat has much stronger antiviral activity than either drug alone.
We have completed a lethality animal study wherein animals were infected with ectromelia virus into the lungs directly. In this study, we found that NV-387 alone treated animals survived 15 days, tecovirimat alone treated animals survived 16 days, and NV-387 plus tecovirimat treated animals survived 19 days, whereas vehicle-treated animals died in 8 days.
This lung-infection study emulates infection from aerosolized dispersion of the virus, as may be expected in a bioterrorism scenario.
Survival Lifespan of Lethally Infected Mice – Lung Infection with Ectromelia Virus
Previously, on November 14, 2023, we have reported that in a lethal intradigital footpad infection of mice with ectromelia virus, oral NV-387 treatment led to lifespan improvement comparable to oral tecovirimat treatment, with both treatments resulting in 14 days survival, whereas vehicle treated animals died in 8 days. Moreover, combined treatment with both NV-387 and tecovirimat resulted in a significantly improved survival of 17 days in this study.
Survival Lifespan of Lethally Infected Mice – Intradigital Footpad Infection with Ectromelia Virus
This intradigital footpad infection study emulates the skin-to-skin transfer of the virus as in sexual transmission, such as that in the case of current Clade 1 MPox virus epidemic in the DR Congo; Clade 1 MPox is more deadly than the Clade 2 MPox; the latter had caused a small pandemic recently with sexual mode of transmission (https://www.sciencefocus.com/news/monkey-pox-new-strain , May 5, 2024).
Tecovirimat is the drug approved for smallpox under “animal rule” and is stockpiled by the Biomedical Advanced Research and Development Authority (BARDA). It was mobilized from the stockpile during the recent MPox Clade 2 pandemic. BARDA is interested in development of additional poxvirus therapeutics as per a recent Broad-Agency Announcement (BAA). There is significant interest in the development of a smallpox therapeutic that works well by itself, as well as in combination with the known drug, tecovirimat. Tecovirimat has a low barrier of escape; a single mutation in one protein can enable the virus to escape this drug, adding to the significance of additional smallpox drug development.
Therefore we believe that NV-387 is a viable clinical candidate to be developed by itself for the treatment of poxvirus infections under the US FDA “Animal Rule”. In addition, we believe that the combination of NV-387 and tecovirimat could reduce the potential for escape resistant generation against tecovirimat, as is known with other drug combination studies against viruses.
A safe and effective antiviral drug that the virus would not escape by simple mutations or field evolution is the holy grail of antiviral drug development. We believe that the NanoViricides Platform technology meets this challenge.
NanoViricides is Well Positioned with Its Clinical and Pre-Clinical Pipeline and Unique Host-Mimetic, Virus Killing, Technology Platform Intending To Revolutionize Treatment of Viral Infections
SHELTON, CONNECTICUT – Monday, July 1, 2024 — NanoViricides, Inc. (NYSE Amer.: NNVC) (the “Company”), a clinical-stage global leader in broad-spectrum antiviral nanomedicines, elaborates on its current assets and plans towards becoming a successful pharmaceutical company intending to revolutionize the treatment of viral infections.
NV-387, our lead broad-spectrum antiviral drug candidate has completed Phase I clinical trial in healthy subjects with no drop-outs and no reported adverse events, indicative of excellent safety and tolerability in humans.
This single drug, NV-387, has been found to be highly active against a number of different types of viruses. In fact, its activity has, in animal models: • Resulted in curing lethal lung RSV infection; • Substantially bested the activities of approved drugs (Tamiflu, Xofluza, Rapivab) for Influenza; • Substantially bested the activity of Remdesivir against lethal coronavirus infection; and • Matched the activity of TPOXX against poxvirus.
We believe that this ultra-broad-spectrum antiviral activity of NV-387 became possible because NV-387 is designed to mimic an invariant host feature that over 90% human pathogenic viruses employ for attachment and infection.
A single antiviral drug that can effectively treat almost any respiratory viral infection would be a revolutionary development in the treatment of viral diseases, reminiscent of the revolution caused by penicillin in the treatment of bacterial infections, we believe.
We are rapidly moving towards Phase II studies to establish effectiveness against a viral disease in humans. We plan on Phase II studies for RSV, with the goal of developing a therapeutic for the treatment of pediatric patients, which is the greatest unmet need in RSV infection.
The market sizes for the viral diseases that NV-387 has already been found to be a viable clinical drug candidate as above are substantial.
The market size for RSV is estimated at $2.6 Billion in 2024, growing to $4.3 Billion in three years, at a rate of 18.9% as reported by GrowthPlusReports.
The market size for Influenza and Bird Flu is estimated at $4.6 Billion in 2024, growing to an estimated $5.9 Billion in three years, at a rate of 8.5% as reported by DelveInSight. In case a pandemic occurs, reality may outrun such projections by magnitudes, as was seen with the COVID pandemic.
The market size for COVID, as it has become an endemic disease by now, can be expected to be similar to the market size for Influenza while new COVID drugs are being developed, since COVID continues to cause at least twice as large a fatality rate as Influenza in the USA alone.
Thus we estimate an overall market size of around $16 Billion in three years for these three viruses, that NV-387 is expected to tackle.
Thus NV-387 alone is poised to propel NanoViricides towards great success in a near-term horizon. We plan to license or co-develop our various drug candidates against multiple viral diseases to other Pharma Companies. In addition, we plan on seeking non-dilutive funding for the development of drugs that are of interest for biodefense.
We have already demonstrated the ability to manufacture our own drug candidates at several Kilograms scales in cGMP-compliant processes for clinical trials. Our campus comprises a multi-Kg scale cGMP-compliant manufacturing facility with Class 100 clean rooms. We have demonstrated capabilities for manufacture of the drug substance, and thereafter formulate, fill-finish-and-package the drug products for clinical trials in this facility.
We believe that our existing manufacturing facility would be adequate for market entry of NV-387 for the pediatric patients segment when the drug is approved by the FDA.
We also have a drug in development against herpesviruses, NV-HHV-1, formulated as a skin cream, that we plan on advancing through clinical trials for regulatory approval as a topical treatment of Shingles/Chickenpox skin rashes, HSV-1 “cold sores”, as well as HSV-2 “genital ulcers”. NV-HHV-1 had completed IND-enabling studies by October 2019 just before the COVID-19 pandemic broke out, whereupon we took up the challenge of developing a highly effective drug to treat all coronavirus infections. We have an oral formulation of NV-HHV-1 in development for systemic use to treat herpesvirus infections.
Our unique, host-mimetic, directly virus-attacking, technology platform has enabled the development of a number of drug candidates against several viral diseases. We believe these developments will continue to provide additional drug candidates to feed our pipeline for several years to come.
Thus, we believe that we are on the verge of substantial success and expansive growth in the near future: • having successfully completed Phase I of our first drug candidate, • having amassed substantial data demonstrating superior antiviral activity of our drug candidates in animal models, • and now being poised to enter into Phase II human clinical trials.
Orally Administered NV-387 Results in Ideal Flat Blood ConcentrationProfile for Sustained Antiviral Effect -A First-In-Class, Broad-Spectrum Antiviral Agent Intending ToRevolutionize Treatment of Viral Infections Including RSV, COVID,Influenzas and More
SHELTON, CONNECTICUT – Tuesday, June 11, 2024 — NanoViricides, Inc. (NYSEAmer.: NNVC) (the “Company”), a clinical-stage global leader in broad-spectrum antiviralnanomedicines, reports that its clinical stage lead nanoviricide broad-spectrum antiviral drugcandidate, NV-387, results in an ideal flat blood concentration profile for an extended time periodupon oral administration in two different animal models.This unusual but highly desirable, extended flat time profile of blood concentration of orallygiven NV-387 enables sustained antiviral effect over a long period of time, allowing infrequentdosing regimens. The blood concentration of NV-387 increased to a peak in approximately the first hour, and thenremained almost constant for eight hours or longer, thereafter, the concentration declined to reachbaseline at about twelve hours; upon oral administration of a first dose of NV-387. This wasfound to be the case in studies involving two different animal models, namely, rats and dogs.After repeated dosings, the plateau of the sixth dose lasted for at least 24 hours, thereafterdeclining to baseline at about 36 hours, in both the rat and dog animal models.The same plateau profile phenomenon was observed in both male and female animals, as well asin both species of animals, namely, rat and dog. The blood concentration profile of NV-387 is indicative of the formation of a buffering reservoirof the drug in the host that releases the drug at a regular rate into the bloodstream.The Company has recently reported that NV-387, when given as a slow bolus intravenousinfusion, was found to result in a relatively flat plateau of blood concentration of the drug withvery slow decline over a 24 hour period in a cynomolgus monkey model.The flat time profile of NV-387 indicates that even at very high dosings, its blood concentration isunlikely to result in unwanted side effects. Typical drugs result in a rapid rise in bloodconcentration of the drug in generally the first hour to a peak, thereafter rapidly exponentiallydecreasing to baseline in 3-6 hours. In order to ensure that the concentration of the drug issufficiently high to provide antiviral effect at say 2-4 hours from dosing, the drug dose chosenwould be relatively high, and can therefore result in a substantially greater drug concentration inthe beginning, which can result in unwanted side effects. Therefore, a sustained, nearly flat drugconcentration profile is highly sought-after. In the repeat-dose oral NV-387 administration studies in both rat and dog models cited above, twodoses were given on the first day (at 0h and 12h), followed by third dose at 24 h, and then dailydoses at 24 hour intervals, for a total of six doses in five days. The Company has previously reported that NV-387 when administered orally resulted in strongantiviral effects in several respiratory viruses. In lethal infections with hCoV- NL63 (a model forSARS-CoV-2, cause of COVID), RSV, as well as Influenza A/H3N2, orally administered NV-387was found to be superior to approved therapeutics where available. In fact, the Company has found that NV-387 enabled complete cure of RSV infection in themouse model of lethal lung infection with RSV A2. The Company therefore believes that NV-387 is a first-in-class, broad-spectrum antiviral agentthat could be a revolutionary single drug for the treatment of a multitude of respiratory viralinfections including RSV, COVID, Influenzas and potentially other viruses. The presented non-clinical studies of pharmacokinetics of orally administered NV-387 providesupport that the strong antiviral effect seen in these antiviral animal model efficacy studies is theresult of NV-387 circulating in the body and exerting its direct antiviral effects.”NV-387 is a unique host-mimetic, direct acting antiviral drug that the virus is highly unlikely toescape,” said Anil R. Diwan, Ph.D, President, “We were pleasantly surprised that NV-387 ishighly active upon oral administration, and now we have found that this is because it indeedcrosses into the bloodstream upon oral administration, enabling systemic antiviral effects.” Hefurther explained that, “NV-387 may be the very first or one of very few nanomedicines that areeffective upon oral administration. Nanomedicines in general are restricted to injectable or topicaldelivery. NV-387 is thus unique in this respect.” NV-387 has recently completed Phase I human clinical safety tolerability studies with no reportedadverse events in India, as the Company has reported previously. About NanoViricides NanoViricides, Inc. (the “Company”) (www.nanoviricides.com) is a development stage companythat is creating special purpose nanomaterials for antiviral therapy. The Company’s novelnanoviricide® class of drug candidates are designed to specifically attack enveloped virusparticles and to dismantle them. Additionally, nanoviricides mimick the host-side features that theviruses continue to require in spite of mutations, and therefore the viruses would be highlyunlikely to escape the nanvoricide drugs. Our lead drug candidate is NV-387 (drug product NV-CoV-2) for the treatment of RSV,COVID-19, Long COVID, Influenza, Bird Flu H5N1, and other respiratory viral infections.NV-387 has successfully completed a Phase 1a/1b human clinical trial in healthy subjects with noreported adverse events even at the highest and repeated dosages. This trial was conducted by thedrug sponsor, Karveer Meditech Pvt. Ltd., our licensee and collaborator in India.The Company is currently focused on advancing NV-387 into Phase II human clinical trials fortreatment of RSV infection. Our other advanced candidate is NV-HHV-1 for the treatment of Shingles rash, HSV-1 “coldsores” and HSV-2 “genital ulcers”. The Company cannot project an exact date for filing an INDfor any of its drugs because of dependence on a number of external collaborators and consultants.The Company is also developing drugs against a number of viral diseases including oral andgenital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu,H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus,among others. NanoViricides’ platform technology and programs are based on the TheraCour®nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricidesholds a worldwide exclusive perpetual license to this technology for several drugs with specifictargeting mechanisms in perpetuity for the treatment of the following human viral diseases:Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus(HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV),Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus,Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license forpoxviruses and/or enteroviruses if the initial research is successful. The Company’s technology isbased on broad, exclusive, sub-licensable, field licenses to drugs developed in these areas fromTheraCour Pharma, Inc. The Company’s business model is based on licensing technology fromTheraCour Pharma Inc. for specific application verticals of specific viruses, as established at itsfoundation in 2005. As is customary, the Company must state the risk factor that the path to typical drug developmentof any pharmaceutical product is extremely lengthy and requires substantial capital. As with anydrug development efforts by any company, there can be no assurance at this time that any of theCompany’s pharmaceutical candidates would show sufficient effectiveness and safety for humanclinical development. Further, there can be no assurance at this time that successful results againstcoronavirus in our lab will lead to successful clinical trials or a successful pharmaceuticalproduct. This press release contains forward-looking statements that reflect the Company’s currentexpectation regarding future events. Actual events could differ materially and substantially fromthose projected herein and depend on a number of factors. Certain statements in this release, andother written or oral statements made by NanoViricides, Inc. are “forward-looking statements”within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the SecuritiesExchange Act of 1934. You should not place undue reliance on forward-looking statements sincethey involve known and unknown risks, uncertainties and other factors which are, in some cases,beyond the Company’s control and which could, and likely will, materially affect actual results,levels of activity, performance or achievements. The Company assumes no obligation to publiclyupdate or revise these forward-looking statements for any reason, or to update the reasons actualresults could differ materially from those anticipated in these forward-looking statements, even ifnew information becomes available in the future. Important factors that could cause actual resultsto differ materially from the company’s expectations include, but are not limited to, those factorsthat are disclosed under the heading “Risk Factors” and elsewhere in documents filed by thecompany from time to time with the United States Securities and Exchange Commission andother regulatory authorities. Although it is not possible to predict or identify all such factors, theymay include the following: demonstration and proof of principle in preclinical trials that ananoviricide is safe and effective; successful development of our product candidates; our abilityto seek and obtain regulatory approvals, including with respect to the indications we are seeking;the successful commercialization of our product candidates; and market acceptance of ourproducts. The phrases “safety”, “effectiveness” and equivalent phrases as used in this press release refer toresearch findings including clinical trials as the customary research usage and do not indicateevaluation of safety or effectiveness by the US FDA. “NOAEL” means “No-Observed-Adevrese-Event-Level”, which is the maximum dosageemployed at which there were no adverse events found in animal studies. “MTD” means “Maximum Tolerated Dose”, which is the maximum dosage employed that doesnot compromise survival of the animals. FDA refers to US Food and Drug Administration. IND application refers to “Investigational NewDrug” application. cGMP refers to current Good Manufacturing Practices. CMC refers to”Chemistry, Manufacture, and Controls”. CHMP refers to the Committee for Medicinal Productsfor Human Use, which is the European Medicines Agency’s (EMA) committee responsible forhuman medicines. API stands for “Active Pharmaceutical Ingredient”. API means activepharmaceutical ingredient.
A Novel Broad-Spectrum Antiviral Against Influenza A Viruses, NV-387, Could Be an Important Weapon to Fight Bird Flu H5N1, Says NanoViricides
SHELTON, CONNECTICUT – Monday, June 24, 2024 — NanoViricides, Inc. (NYSE Amer.: NNVC) (the “Company”), a clinical stage global leader in broad-spectrum antiviral nanomedicines, comments that the ultra-broad antiviral NV-387 could be an important weapon against bird flu H5N1 viruses.
NanoViricides has recently found that its host-mimetic clinical drug candidate NV-387 was substantially superior to the three approved drugs against influenza, namely Oseltamivir (Tamiflu®, Roche), Peramivir (Rapivab®, Biocryst), and Baloxavir (Xofluza®, Shionogi, Roche) in a lethal animal model study of Influenza A/H3N2 virus lung infection.
Further, in this study, NV-387 was also found to protect the lungs of the infected animals from viral damage as well as immune system damage, supporting a strong antiviral effect.
These results have arrived just as the bird flu H5N1 threat potential has increased significantly due to its spread into several mammalian species. While dairy cattle have suffered relatively mild infections, some other mammals, particularly cats on farms have died of brain infection with this virus. Only four human cases have occurred so far with one person dying in Mexico, while the three other cases all in the USA have recovered.
NV-387 is anticipated to be a strong drug candidate that would remain effective against HPAI H5N1 even as significant mutations occur. This is because of two main reasons:
1. The Multi-Basic Site (MBS) in the H5. All HPAI possess a MBS in the H5 which is highly positively charged. The MBS enables strong interaction with sulfated proteoglycans (“S-PG”). Since NV-387 is a host-mimetic of S-PG, it is expected that NV-387 would have a strong effect against the MBS-carrying HPAI H5N1. 2. The broad-spectrum activity of NV-387. NV-387 is active against many very different viruses including Influenza A, RSV, COVID, Seasonal Coronaviruses, and even Poxviruses. This is because of its host-mimetic feature that copies the invariant attachment site common to all of these viruses, the S-PG. The HPAI H5N1 also uses S-PG for attachment, possibly more profoundly than H3N2, because of the MBS in HPAI. Thus NV-387 is likely to continue to work against the HPAI H5N1 despite mutations that cause resistance to other drugs.
In contrast, very few single-point mutations could make the HPAI H5N1 virus resistant to the existing drugs.
Only as few as five mutations in the HA (hemagglutinin) protein of this virus could enable it to gain the ability to efficiently infect humans, and this could lead to a pandemic with much greater fatality rates than with COVID, according to Dr. Redfield, ex-Director of CDC as reported in a NewsNation interview (https://www.newsnationnow.com/health/ex-cdc-director-bird-flu-pandemic/). Bird Influenza viruses use a-2,3-sialic acid receptors whereas human influenza viruses use a-2,6-sialic acid receptors to gain entry into cells. Viruses typically concentrate at heparan sulfate or sulfated proteoglycans (S-PG) prior to gaining cell entry.
Influenza viruses have a high rate of mutations, and further they can mix-and-match the eight segments of genome from other influenza viruses, called re-assortment, or pick portions of these segments, called recombination.
A safe and effective antiviral drug that the virus would not escape by simple mutations or field evolution is the holy grail of antiviral drug development. We believe that the NanoViricides Platform technology meets this challenge.
Dr. Diwan has been President and Chairman of the Board of the Company since its founding in 2005 Dr. Diwan spearheaded the efforts for the Company’s 2013 uplisting from the OTC Markets to NYSE-American. Dr. Diwan has led several of the Company’s financing efforts since 2010.
Dr. Diwan invented novel polymeric micelle-based nanomedicine technologies as early as 1991. Dr. Diwan is a prolific inventor and a serial entrepreneur. Prior to co-founding NanoViricides, Inc., he has founded TheraCour Pharma, Inc., a privately held company focused in nanomedicines and cell-targeted drug delivery, and AllExcel, Inc., a company with diverse portfolios including nanomedicines, small chemicals, device technologies, as well as informatics. He has won several NIH SBIR (small business innovation research) grant awards. Anil holds a Ph.D. from Rice University, TX, a B.Tech. from Indian Institute of Technology, Mumbai (IIT-B), India, and has consistently held high scholastic ranks and honors. Dr. Diwan has over 25 years of Bio-Pharmaceutical R&D experience with over 20 years as an entrepreneur.
He has several patents issued internationally resulting from three fundamental international patent applications. Under Dr. Diwan’s leadership, NanoViricides, Inc. has been able to keep both administrative and R&D costs at extremely low levels while robustly expanding the drug pipeline every year. Dr. Anil R. Diwan was recognized as “Researcher of the Year” by BusinessNewHaven, a Connecticut Area Business Journal, in 2014.
Ms. Meeta R. Vyas, MBA (Fin.), BS (Chem. Eng.)
interim Chief Financial Officer
Ms. Vyas is known as a strong leader with board level experience and successful achievements as a Senior Executive in a broad range of entities including publicly listed corporations, non-revenue generating entities, and medium to large size companies. Meeta has over twenty-five years of experience in performance and process improvement of both publicly listed companies and non-revenue producing entities, in areas ranging from Finance and Operations to Strategy and Management. Meeta holds the distinction of being the first Indian woman to be named CEO of a publicly listed US corporation, Signature Brands, Inc., best known for “Mr. Coffee” and “Health-O-Meter” brand products. As CEO, acting COO and Vice Chairman of the Board of Signature Brands, Inc., she was responsible for the development and implementation of a turnaround plan, resulting in a return to profitability and growth within a short period of time. Later, as the CEO of the World-Wide Fund for Nature – India (WWF-India) and then as a Vice President of the National Audubon Society (USA), both non-revenue generating entities, Meeta successfully raised unrestricted funding that significantly exceeded annual requirements and also instituted financial processes to measure a variety of performance metrics. Earlier in her career, she was responsible for designing the strategy and initiating the implementation plan for the highly successful information technology outsourcing program at General Electric (GE). Also at GE, Ms. Vyas ran GE Appliances’ Range Products business unit having revenues exceeding $1 Billion where her team doubled operating income in less than two years. Prior to that, as a management consultant with McKinsey and Company, she served publicly listed companies in chemicals, industrial, and technology markets, primarily focusing on growth strategies, valuations, post-merger integrations, and logistics operations. Meeta is married to NanoViricides, Inc. President and Chairman Anil R. Diwan.
Ms. Vyas holds a MBA in Finance from Columbia University’s Graduate School of Business, and a BS in Chemical Engineering from the Massachusetts Institute of Technology.
NanoViricides won the IAIR AWARD as Best North American Company for Leadership in the Nanomedicine Sector.
Randall W. Barton, PhD.Chief Scientific Officer – Consulting
Dr. Barton has experience in drug discovery and development of both small molecule and biological drug candidates in virology, immunology, inflammation, and cardiovascular diseases in the pharmaceutical and biotech industry as well as academic research and teaching experience. Most recently, he was Vice-President of Drug Discovery at A&G Pharmaceuticals, a biologics and diagnostics company. He retired at the Director level after 20 years at Boehringer Ingelheim Pharmaceuticals. During his time at Boehringer Ingelheim he performed drug development pre-clinical studies on nevirapine (Viramune), a non-nucleoside inhibitor of HIV reverse transcriptase and an important HIV drug.
Prior to joining Boehringer Ingelheim, he was on the faculty at the University of Connecticut Medical School where he was the recipient of an NIH Career Development Award conducting research and teaching in immunology. Dr. Barton has authored over 80 scientific publications, and has been the principal investigator leading to 5 patents. He has a Ph.D. in biochemistry from the University of Tennessee at Oak Ridge National Laboratory and a B.A. from Indiana University.
Jayant Tatake, PhD.
Vice President, R&D
Jay Tatake is an organic chemist with over 25 years of experience in Research and Process Development of fine chemicals. His experience encompasses production scale-up, and large scale manufacture of raw materials for pharmaceuticals. Before joining NanoViricides, Inc., he was Assistant Director of Analytical R&D at Interpharm, Inc. Prior to that, he was Director of Analytical Services at Pharmax Group, Inc. Dr. Tatake has several years experience in Analytical methods development and Quality Control in cGMP environment. His experience includes bio-analytical methods development. Prior to Pharmax Group, he was in the Pharmacology Department, University of Connecticut Health Center, where he synthesized and developed novel bio-conjugates for bio-diagnostics applications.
Jay has a Ph.D. from Department of Chemical Technology, University of Bombay. He is a member of American Chemical Society (ACS). He has published several papers in leading journals and is a co-inventor of several patents.
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SciSparc Signs Non-Binding Letter of Intent for Exclusive Global Out-Licensing of Pain Treatment for Approximately $6 million
SPRC announced a non-binding letter of intent to spin off its advanced clinical-stage pharmaceutical portfolio SPRC has four main candidates in various stages of clinical development
SciSparc is advancing its clinical research with a robust pipeline of trials targeting major neurological disorder
Yesterday’s profile retested highs again after making a double digit move during yesterdays session.
We have another company that we want you to put on your radar this week as we head towards the weekend.
Pull up SPRC Immediately.
In the dynamic world of biotechnology and pharmaceuticals, SciSparc Ltd. (Nasdaq: SPRC) is carving out a unique niche. Amidst significant market fluctuations earlier this year, the company is demonstrating resilience and innovation through strategic clinical and corporate initiatives. These efforts are not only stabilizing the company but also setting the stage for substantial long-term growth. With groundbreaking clinical trials and bold spin-off strategies, SciSparc is on a path to unlock considerable value for its shareholders. As the company continues to make strides in medical research and strategic business moves, investors have ample reasons to be optimistic about SciSparc’s future potential.
SciSparc Ltd. (Nasdaq: SPRC) is emerging as a noteworthy player in the biotech and pharmaceutical sector, despite facing significant market fluctuations earlier this year. The company is actively pursuing clinical and corporate strategies aimed at achieving stability and long-term growth, thereby enhancing shareholder value.
SciSparc is advancing its clinical research with a robust pipeline of trials targeting major neurological disorders. Key projects include:
Tourette’s Syndrome: A phase IIb trial for SCI-110 is underway, presenting a potential breakthrough for this condition.
Alzheimer’s Disease: A phase II trial has been completed, offering promising insights for future treatments.
Autism Spectrum Disorder: A notable trial for SCI-210, focusing on children with autism, is in progress. This double-blind, placebo-controlled trial aims to address core symptoms of autism, potentially improving the quality of life for affected children and their families.
SciSparc’s recent patent acquisitions, including those for the treatment and prevention of depression, further bolster its competitive edge and intellectual property portfolio.
The company has four main candidates in various stages of clinical development.
SPRC also has a controlling interest in a company that sells hemp-oil-based products on Amazon.
Back in April, SPRC pulled an unorthodox move and acquired a company called AutoMax Motors Ltd., which is a leading Israeli auto importer………….. Strange move for a Pharma company, no?
If you keep following the story then just last week when SPRC announced a non-binding letter of intent to spin off its advanced clinical-stage pharmaceutical portfolio and its equity stake in SciSparc Nutraceuticals Inc. (which holds the hemp/Amazon business).
Those assets are valued at roughly 11.6Mill under the agreement.
The company is still in negotiations with Canada-based Miza III Ventures Inc. about the spinoff, but the press release says SPRC will gain a controlling interest in Miza as part of the deal.
One could ultimately conclude that SPRC itself will be focused on the auto importing business, while the canna business will move to Canada under Miza.
Automax reported strong revenues of more than $112M in 2023.
You can see that activity started picking up Tuesday when the company put out news regarding a new patent application. SPRC exploded all the way to 1.31 after closing at .82 the day before. It has pulled back quite a bit off of the recent highs and is continuing to see above average interest. This is a great time to start researching this one.
SciSparc Announces U.S. Patent Application for Treating Metabolic Syndrome and Weight Loss
TEL AVIV, Israel, July 16, 2024 (GLOBE NEWSWIRE) — SciSparc Ltd. (Nasdaq: SPRC) (“Company” or “SciSparc”), a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders and rare diseases of the central nervous system, announced that an additional patent application with the United States Patent and Trademark Office (“USPTO”) was submitted as part of its ongoing collaboration with Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind”), a clinical-stage biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems and invented with Professor Joseph Tam from the Hebrew University’s technology transfer company, Yissum. The patent application is for the novel proprietary composition of Palmitoylethanolamide (“PEA”), the active ingredient of SciSparc’s proprietary CannAmide™ with Clearmind’s innovative MEAI compound (5-methoxy-2-aminoindane) for treating metabolic syndrome and obesity.
According to data collected by the Centers for Disease Control and Prevention from the period 2017-2020, the prevalence of obesity in the United States of adults aged 20 and over was 41.9%.
According to Emergen Research, the global obesity treatment market size was $15 billion in 2022 and is expected to grow at a compound annual growth rate of 10.0% during the forecast period. Rising prevalence of obesity and technological advancements in weight loss equipment are key factors driving market revenue growth.
Overall, as part of this collaboration, twelve other patent applications have been filed by Clearmind with the USPTO for various compositions, including the proprietary composition of SciSparc’s PEA with Clearmind’s MEAI compound for the treatments of alcohol use disorder, cocaine addiction and obesity and its related metabolic disorders.
PRODUCTS
SCI-110
SCI-110, our proprietary drug candidate, containing Dronabinol (FDA approved synthetic form of THC), with the endocannabinoid palmitoylethanolamide (PEA).
Designed to stimulate cannabinoid receptors across the Central Nervous System and inhibit the metabolic degradation of endocannabinoids in order to improve uptake of THC, the expected benefits of SCI-110 are an increase in efficiency of oral administration, and in turn a decrease in dosage requirements, side effects and adverse events.
This product is being developed under the accelerated regulatory path of 505 (b)(2) application focused on augmenting FDA-approved natural and synthetic cannabinoids to create alternate therapies that potentiate the effects of cannabinoids and target the receptors implicated in modulating the central nervous system.
This approach qualifies us for access to the FDA’s 505 (b)(2) regulatory strategy, created to facilitate the submission of novel drug candidates that meet specific criteria to the FDA for review. The 505 (b)(2) application provides us with several advantages as compared to a typical New Drug Application, including potential; lower risk and development costs, and a potentially expedited time to market. Indications currently being investigated for treatment with SCI-110 include:
Our proprietary drug candidate containing cannabidiol (CBD), a non-psychoactive cannabinoid, and PEA.
This product is initially being developed under the regulation of the Israeli Medical Cannabis Agency (IMCA) – the agency that leads the regularization of the medical cannabis field in Israel and is the first of its kind in the world. It is a complex, unique, innovative and original process. Conducting clinical trials and development under the regulation of the HQR ostensibly enables rapid and specific registration processes in a track that is unique to Israel.
The company intends to further develop the product for markets outside Israel as well. Indications currently being investigated for treatment with SCI-210 include – Autism Spectrum Disorder (in clinical trials) – Status Epilepticus – a form of seizures that are severe and sometimes fatal. This indication is currently investigated in pre-clinical settings.
SCI-160 is an innovative, proprietary synthetic CB2 receptor agonist created, among others, for the treatment of pain and is currently in pre-clinical studies. The CB2 receptor agonist used in this formulation – HU-433 – was invented and synthesized by Professor Raphael Mechoulam, Ph.D., Chairman of the SciSparc Scientific Advisory Board, and is protected under a patent granted in the U.S. and Europe.
CannAmide™ is an immediate unique palmitoylethanolamide (PEA) oral formulation for the reduction of chronic pain and inflammation. PEA is a cannabinoid mimetic lipid molecule found throughout the body, including the central nervous system. Similar to cannabinoids, PEA has been shown to have neuroprotective, anti-inflammatory, analgesic and anti-convulsant properties.
CannAmide is currently available in tablet form, with each dose containing 400mg active pharmaceutical ingredient. It has been designated a product license issuance from the Natural and Non-prescription Health Products Directorate (NNHPD) from Health Canada, for sale as a supplement within the nutraceuticals market.
SciSparc Signs Non-Binding Letter of Intent for Exclusive Global Out-Licensing of Pain Treatment for Approximately $6 million
SciSparc will receive additional payments and execution fees if certain milestones are met
TEL AVIV, Israel, July 17, 2024 (GLOBE NEWSWIRE) — SciSparc Ltd. (Nasdaq: SPRC) (“Company” or “SciSparc”), a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders and rare diseases of the central nervous system, announced that it has signed a non-binding letter of intent (“LOI”) with an undisclosed biotechnology company to pursue the out-licensing of its SCI-160 program (the “Assets”) for the treatment of pain.
According to the LOI, the biotechnology company would receive exclusive, royalty-bearing global licenses to develop and sublicense the Assets. In exchange, SciSparc would be entitled to receive payment of $3 million in ordinary shares and pre-funded warrants of the biotechnology company, as well as potentially additional payments and execution fees of approximately $3 million in cash, if certain milestones will be met.
SCI-160 is an innovative, proprietary synthetic cannabinoid formulation for the treatment of pain. Based on pre-clinical studies conducted by the Company, the proprietary combination of cannabinoids and Palmitoylethanolamide has been found to be involved in mediating analgesic effects in the peripheral nervous system without causing significant side effects in both acute and chronic pain.
Moreover, in certain studies, SCI-160 was found to be well tolerated, did not cause any significant adverse clinical effects, and had a comparable analgesic effect to high-dose morphine and, in some individual instances, exerted even greater potency. While prescription opioids are effective treatments for moderate-to-severe pain, abuse of such opioids is a significant public health issue according to the Centers for Disease Control and Prevention. According to The National Center for Health Statistics, drug overdose deaths involving prescription opioids rose from 3,442 in 1999 to 14,716 in 2022.
“This LOI will allow us to focus on the Company’s core pharmaceutical activities that involve three late-stage programs for the treatment of Alzheimer’s disease, Tourette syndrome, and autism. We believe that the Company’s strong portfolio will enable us to maximize shareholder value,” said Oz Adler, SciSparc’s Chief Executive Officer.
SciSparc Signs Non-Binding Letter of Intent for Spin Off of Advanced Clinical Stage Pharmaceutical Portfolio to Publicly Traded Company
According to the agreement, SciSparc’s pharmaceuticals assets are valued at approximately $11.6 million
TEL AVIV, Israel, July 08, 2024 (GLOBE NEWSWIRE) — SciSparc Ltd. (Nasdaq: SPRC) (“Company” or “SciSparc”), a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders and rare diseases of the central nervous system, announced today it signed a non-binding letter of intent (the “LOI”) to spin off its advanced clinical stage pharmaceutical portfolio and its equity stake in SciSparc Nutraceuticals Inc. (collectively, the “Target Assets”). The LOI references a proposed asset and share purchase agreement (the “Agreement”), the definitive agreement of which is to be negotiated between the Company and Miza III Ventures Inc. (“Miza”) (TSXV: MIZA.P), a publicly traded company on the Toronto Stock Exchange Venture in Canada.
The Agreement is based on the approximate total USD 3.3 million (CAD 4.5 million) enterprise value of Miza, when including its USD 1.0 million cash position, and an approximate USD 11.6 million (CAD 15.8 million) value of SciSparc’s assets.
Pursuant to the LOI, SciSparc will sell, assign, convey and transfer to Miza the Target Assets in consideration for 63,300,000 common shares of Miza and up to 48,000,000 Miza contingent rights based on pre-determined milestones. Following the closing of such transaction, SciSparc would hold a controlling interest in Miza, the exact percentage of which is contingent on agreeing definitive terms between the parties. The resulting entity, of which SciSparc will hold a stake in the resulting entity ranging from a minimum of approximately 75% to a maximum of 84.53%, will be active in both the pharmaceutical and supplement sectors.
The Agreement aligns with SciSparc’s strategy of creating value for its shareholders and follows the merger agreement and transaction concerning AutoMax Motors Ltd., as previously announced by SciSparc on April 11, 2024.
SciSparc’s pharmaceutical portfolio includes SCI-110 for treating persons with Tourette syndrome, which is subject to a phase IIb clinical trial, SCI-110 for treating persons with Alzheimer’s disease, the phase II clinical trial of which has been completed, and SCI-210 for treating children with autism, subject to a randomized, double-blind and placebo-controlled trial that commenced in the first quarter of 2024.
SciSparc to Acquire AutoMax
TEL AVIV, Israel, April 11, 2024 (GLOBE NEWSWIRE) — SciSparc Ltd. (Nasdaq: SPRC) (“Company” or “SciSparc”), a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders and rare diseases of the central nervous system, announced today that it signed a merger agreement (the “Agreement”) with AutoMax Motors Ltd. (“AutoMax”), a leading vehicle importer company in Israel.
According to the Agreement, the Company will acquire 100% of AutoMax and establish a new wholly-owned Israeli subsidiary, which would in turn merge with and into AutoMax (the “Acquisition”). Following the Acquisition, it is contemplated that SciSparc shareholders will hold together approximately 50.01% of the share capital of the post-closing combined company (the “Combined Company”).
The Acquisition follows the Company’s announcement in June 2022, in which the Company’s board of directors resolved to review potential strategic transactions to maximize shareholder value. The Company’s ongoing business operations, including its late-stage pharmaceutical segment, will continue to operate.
As a result of the Acquisition, all outstanding shares of AutoMax will be converted into the right to receive ordinary shares of SciSparc. Following the closing, it is contemplated that AutoMax’s equity holders will hold together approximately 49.99%, subject to adjustments, of the Combined Company’s share capital. At the closing of the Acquisition, SciSparc has committed to hold at least $4.25 million in net cash.
The Acquisition is subject to various approvals, including compliance with any regulatory requirements, including certain Israeli court approvals and SciSparc and AutoMax shareholder approvals. Mr. Amitai Weiss, the chairman of SciSparc, is also the chairman of AutoMax.
Mr. Weiss joined the Company in August 2020. He is founder and Chief Executive Officer of Amitay Weiss Management Ltd. Prior to forming his company, he held several positions at Bank Poalei Agudat Israel Ltd., most recently as Vice President of Business Marketing & Development. He currently chairs and serves as director on the boards of several public companies. Mr. Weiss earned his B.A in Economics from New England College, his M.B.A and LL.B from from Ono Academic College in Israel – a branch of the University of Manchester.
Adi Zuloff-Shani, PhD.
Chief Technologies Officer
Dr. Zuloff-Shani joined the Company in February 2016, bringing more than 20 years of experience as a research and development executive in the bio-tech industry and launching start-ups in the healthcare industry. Dr. Zuloff-Shani brought 2 products from bench to market and is currently leading the development of several pharmaceutical products designated to the US, EU and Israeli markets.
Prior to joining us, she served as Vice President Development at Macrocure Ltd. (Nasdaq: “MCUR”) where she lead all research and development activities. Dr. Zuloff-Shani earned her Ph.D. in Human Biology and Immunology from Bar- Ilan University, Israel.
Oz Adler, CPA
Chief Financial Officer and Chief Executive Officer
Mr. Adler joined the Company in September 2017, and since April 2018 serves as the Company Chief Financial Officer .Mr. Adler has a wide variety of managerial, financial, tax and accounting experience. Prior to joining the Company, Mr. Adler was employed as a CPA at Kost Forer Gabbay & Kasierer, a member of Ernst & Young Global. He currently chairs and serves as director on the boards of several private and public companies. Mr. Adler holds a B.A. in Accounting and Business Management from The College of Management, Israel.
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Cash and Deposits at December 31, 2023 were $4.9 million
WLDS recently signed collaboration agreement with Qualcomm to elevate XR experiences with Mudra neural technology
The company has successfully delivered first manufacturing batch of the Mudra Band for Apple Watch
Received purchase order from a leading Japanese industrial automation company for the MDK
Fortune 500 Consumer Electronics Corporation Has Purchased an Evaluation License for Wearable Devices’ MDK
__________________________
Hello Everyone,
We have another profile back on our radar for tomorrow’s session that we want you to research immediately.
You might remember this one from back in November of last year when we profiled it.
We brought WLDS to your attention back on Nov. 1 when it was sitting under .50.
Just 6 sessions later on the 8th we saw it explode all the way up to 1.12 for a massive 100%+ run.
We want you to turn your attention to WLDS again and begin your research on it immediately.
WLDS is a growth company developing a non-invasive neural input interface in the form of a wrist wearable band for controlling digital devices using subtle finger movements. These digital devices include consumer electronics, smart watches, smartphones, AR glasses, VR headsets, televisions, PCs, laptop computers, drones, robots, etc.
Since their technology was introduced to the market in 2014, they have been working with both Business-to-Business (B2B) and Business to Consumer (B2C) customers as part of their push-pull strategy.
They are now in the transition phase from research and development to commercialization of our technology into B2B products. At the same time, they are in the final stage of manufacturing their first B2C consumer product, the “Mudra Band”, an aftermarket accessory band for the Apple Watch which allows touchless operation and control of the watch. Headquartered in Israel, the company was founded in March 2014 by Asher Dahan, Guy Wagner and Leeor Langer, with renowned expertise in the fields of analog sensors, signal processing, deep learning and machine learning algorithms, software, and human-computer interaction.
Wearable Devices Announces Full Year 2023 Financial Results and Provides Corporate Update
2023 Achievements Position Wearable Devices for Growth in 2024
YOKNE’AM ILLIT, Israel, March 15, 2024 (GLOBE NEWSWIRE) — Wearable Devices Ltd.(Nasdaq: WLDS, WLDSW) (“Wearable Devices” or the “Company”), a technology growth company specializing in artificial intelligence (“AI”)-powered touchless sensing wearables, today announced its financial results for the year ended December 31, 2023.
Asher Dahan, Chief Executive Officer and Chairman of the Board of Wearable Devices, commented, “2023 was characterized by strategic capital allocation and the execution of our growth strategy as we successfully completed delivery of our first manufacturing batch of the Mudra Band for Apple Watch, and entered into several partnerships with companies and contractors at the forefront of their respective industries. Our net loss increased in pursuit of these milestones, mainly due to strategic investments primarily in sales and marketing and research and development as we continue to innovate and showcase our technology, as well as an enhanced focus on business development on the B2B side of our business.
“Partnerships represent a key part of our business, and we expect our B2B offerings to be a significant driver of revenue for us as we grow. At the beginning of 2024, we launched the B2B Mudra Developer Kit, or MDK, providing our B2B customers with enhanced capabilities and additional features that improve on our traditional Mudra Inspire B2B offering. The MDK allows OEMs to design new, customized gestures along with existing hand and wrist signals to create a user interface specifically tailored to their needs. Subsequent to the end of the year, we announced a collaboration agreement with Qualcomm, a Fortune 500 company, for the development of products using the Qualcomm Snapdragon Spaces XR Developer Platform, and we announced an agreement at the end of 2023 with a leading global defense company to design neural gesture technology for situations where silent activation is crucial. We anticipate interest in our B2B product to grow as the market for wearable devices and AI-based technology expands, with more and more customers recognizing the value that our products can add to their operations.
“Our B2C product, the Mudra Band, is an award-winning aftermarket band for the Apple Watch that allows for touchless control of multiple Apple products. We’re seeing considerable interest in the Mudra Band, and during 2023 we commenced shipment of our first manufacturing batch to preorder customers. We continue to receive orders for the product and have seen demonstrated interest at leading trade shows like CES and MWC, where this technology has been documented and recognized as a leading innovation in the tech field. We’re intently focused on increasing our production capacity to meet anticipated demand for the Mudra Band, and we look forward to the continued innovation of this product as our technology and capabilities improve.”
Mr. Dahan concluded, “We have a comprehensive strategy with innovative B2B and B2C offerings to maximize our presence in what we believe to be a market that is poised for tremendous growth. We are very encouraged by the progress that we made in 2023 and believe that Wearable Devices is positioned for a transformative year in 2024 as we continue to invest in our operations, bring innovative products to market, and showcase the breadth and depth of our technology.”
2023 and Recent Business Highlights
Signed collaboration agreement with Qualcomm to elevate XR experiences with Mudra neural technology
Showcased neural input technology at leading industry conferences, including CES 2024, MWC 2024, SPIE AR VR MR 2024, Tiny ML Summit 2023, and XR Fair Tokyo 2023
Opened new U.S.-based office in Silicon Valley to expand the Company’s presence and foster relationships in the tech and wearables markets
Released MDK for B2B customers allowing OEMs to create a user interface specifically tailored to their operational needs
Successfully delivered first manufacturing batch of the Mudra Band for Apple Watch
Filed patent application with the U.S. Patent and Trademark Office for touchless pinch-to-zoom technology for augmented and virtual reality
Expanded marketing and sales effort with the launch of new Mudra Band website
Completed first stage of deployment testing for a leading XR glasses OEM, satisfying criteria outlined in memorandum of understanding
Introduced revolutionary spatial depth control allowing for depth navigation that adds another dimension to user interaction
Received purchase order from a leading Japanese industrial automation company for the MDK
Joined Open XR and Kronos Group as a voting member to help influence and drive industry growth
Full Year 2023 Financial Highlights:
Research and Development Expenses: Research and development expenses increased 46% to $3.3 million in the full year of 2023 compared to the full year of 2022 as the Company continued to focus on creating disruptive, industry leading technology that leverages AI and proprietary algorithms, software and hardware.
Sales and Marketing Expenses: Sales and marketing expenses increased 47% to $2.0 million in the full year of 2023 compared to the full year of 2022 related to the Company driving awareness of its technology and products across various channels including participation at multiple leading industry conferences.
Net Loss: Net loss increased to $(7.8 million), or $(0.48) per diluted share, for the year ended December 31, 2023, as compared to a net loss of $(6.5 million), or $(0.53) per diluted share, for the year ended December 31, 2022.
Cash Position: Cash and Deposits at December 31, 2023 were $4.9 million.
Inventory: Inventory significantly increased to $1.0 million the end of 2023, as part of the completion of the transition phase from R&D to production and to serve our planned B2C business growth in 2024.
For further details on the Company’s financial results for the year ended December 31, 2023, please refer to the company’s annual report on Form 20-F which is being filed with the SEC today.
Wearable Devices Signs Reseller Agreement to Scale its Licensing Program Reach to Enterprises in South Korea and China
YOKNE’AM ILLIT, Israel, April 01, 2024 (GLOBE NEWSWIRE) — Wearable Devices Ltd.(Nasdaq: WLDS, WLDSW) (“Wearable Devices” or the “Company”), a technology growth company specializing in artificial intelligence (“AI”)-powered touchless sensing wearables, is pleased to announce the signing of a reseller agreement with WisePlus, a premier provider of device software solutions. This collaboration aims to scale the Company’s licensing program reach by enabling local, on-site support and customization for enterprises in the markets of South Korea and China, tapping into WisePlus’ extensive network and expertise in these regions.
Under the terms of the agreement, WisePlus will serve as the official regional reseller of Wearable Devices’ Mudra Technology, allowing WisePlus to demo, negotiate, customize and resell the Company’s Mudra Developer Kit (“MDK”), which is a comprehensive toolset designed to revolutionize the development and integration on Wearable Devices’ neural input technology into solutions, products and services across multiple industries and verticals.
This partnership will leverage WisePlus’ presence and deep market knowledge in South Korea and China, providing fast local access and support to enterprise customers in these areas.
The MDK is designed to empower original equipment manufacturers (“OEMs”) and developers with the ability to create custom gestures and use existing signals to monitor and analyze user behavior. This opens up new product and license opportunities across various market segments, from extended reality (“XR”) and smartwatches to Industry 4.0 and beyond.
“We are very excited to collaborate with Wearable Devices and bring our support, technology and business expertise to promote and create additional demand to the APAC ecosystem,” said Bob Kim, Chief Executive Officer of WisePlus. “The Mudra technology has the needed innovation and product fit to revolutionize the XR-market massive adoption in the near future,” added Mr. Kim.
Asher Dahan, Chief Executive Officer of Wearable Devices, said: “We are delighted to announce our partnership with WisePlus as our chosen added value reseller in the region. With a proven track record of success in the APAC markets, WisePlus brings invaluable insights and strategic guidance to our collaboration. Their proficiency in providing tailored technology driven solutions, seamless integration, and exceptional customer service perfectly aligns with our vision and objectives. With a focus on customization and integration, we are confident that this partnership will empower us to deliver unparalleled user-experiences”.
The MDK is available for value-added resellers , distributors, OEMs, and other partners now also through WisePlus. It provides a comprehensive software development kit including multiple Mudra wristband devices and advanced software tools for programming a vast array of gestures into digital actions on both Android and iOS platforms. The MDK package supports Bluetooth communication, is HID-compatible, and employs deep learning algorithms to translate discreet, intuitive gestures into commands for a wide range of applications and devices.
WisePlus is a pioneering technology firm specializing in advanced embedded system software and on-device AI solutions. Its core expertise lies in developing high-performance, intelligent software that operates seamlessly on a wide array of devices. By integrating cutting-edge artificial intelligence directly onto devices, WisePlus enables smarter, more efficient, and autonomous operations across various applications, from IoT devices to industrial machinery. WisePlus’ commitment is to revolutionize how devices operate, offering enhanced decision-making capabilities and improved user experiences without the need for constant cloud connectivity. Led by Chief Executive Officer Bob Kim, WisePlus is dedicated to pushing the boundaries of what’s possible within the digital domain, fostering innovation that drives the future of technology.
Wearable Devices Teams up with Qualcomm to Elevate Extended Reality Experience
This Collaboration Aims to Transform XR Industry Using the Mudra’s Touchless Control Technology
YOKNEAM ILLIT, ISRAEL, Feb. 28, 2024 (GLOBE NEWSWIRE) — Wearable Devices Ltd. (the “Company” or “Wearable Devices”) (Nasdaq: WLDS, WLDSW), a technology growth company specializing in artificial intelligence (“AI”)-powered touchless sensing wearables, today announced a collaboration agreement with Qualcomm Technologies, Inc. This collaboration will help those looking to use Wearable Devices’ innovative Mudra technology when developing products using the Qualcomm Snapdragon Spaces™ XR Developer Platform, redefining interaction in augmented reality (“AR”) and virtual reality (“VR”) environments.
The Mudra technology, known for its touchless control capabilities, has been optimized to work with Snapdragon Spaces, enhancing the user experience with intuitive, gesture-based interactions. This collaborative approach aims to showcase the innovative potential of combining Mudra’s touchless control technology with Snapdragon Spaces, setting a new standard for immersive digital experiences.
“Partnering with Qualcomm Technologies marks a significant milestone in our journey to revolutionize the XR industry,” said Offir Remez, Executive Vice President of Business Development at Wearable Devices. “The integration of our cutting-edge Mudra technology with Snapdragon Spaces is enhancing the XR experience and reimagining how we interact with digital worlds. Together, we’re paving the way for a future where seamless, intuitive gestures bring us closer to technology, making immersive environments more accessible and engaging than ever before,” added Mr. Remez
Fortune 500 Consumer Electronics Corporation Has Purchased an Evaluation License for Wearable Devices’ MDK
The companies will explore together with the Fortune 500 company’s AI division different use cases of Mudra neural AI controller
YOKNEAM ILLIT, ISRAEL, July 09, 2024 (GLOBE NEWSWIRE) — Wearable Devices Ltd. (the “Company” or “Wearable Devices”) (Nasdaq: WLDS, WLDSW), a technology growth company specializing in artificial intelligence (“AI”)-powered touchless sensing wearables, announced today that a Fortune 500 consumer electronics corporation (“Customer”) has purchased a special license for its state-of-the-art Mudra Development Kit (“MDK”) to evaluate certain deep-level capabilities.
The MDK enables developers to create unique experiences with the Mudra Band and Mudra Application Programming Interface. This powerful toolset will enable the Customer’s development team to seamlessly integrate advanced functionalities into their upcoming products, enhancing user experience through innovative gesture control technology.
The Customer, ranked among the Fortune 500 companies, is renowned for its cutting-edge technology and high-quality consumer electronics products, which include smartphones, televisions, home appliances, and more. With a strong global presence and a reputation for innovation, this company is ideally positioned to leverage the capabilities of the MDK for developing next-generation user interfaces.
Asher Dahan, Chief Executive Officer of Wearable Devices, commented, “We are excited to see our Mudra technology gaining recognition by a prominent player in the consumer electronics market. This special license to evaluate possible deep-level integration marks a significant step forward for us, as it demonstrates the growing recognition of our technology’s potential to revolutionize user interactions, particularly in applications such as extended reality (XR), televisions, 3D displays, and laptops. We look forward to seeing the innovative applications and products that will emerge from this collaboration.”
The MDK is designed to provide developers with the tools needed to implement sophisticated gesture control features in their applications. By leveraging Wearable Devices’advanced neural input technology, developers can create intuitive and responsive user interfaces that enhance the overall user experience.
Project execution expert. Talent in business leading and strategic planning. Manager and team leader. High expertise in major corporate decisions, experience managing the overall operations and resources of the Company.
Guy Wagner
Company President & Chief Scientist, Co-Founder Director
Hardware expert and main inventor. Multi- disciplinary expertise in board design, biomedical signal processing, embedded programming and sensor design.
Leeor Langer
CTO & Co-Founder
Algorithms expert. Machine learning, and signal / image processing developer. Lead algorithms engineer in industry and academia. Wrote several papers and articles.
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I hope that you have been watching our last few profiles. Several of our more recent ones have gone on to make strong short term double digit moves. Our last one in particular was an exciting one to watch trade during the session.
We have another company that is fresh to our following.
We have never come across this ticker before but after taking a Quick Look at it, we all agree that this is a company tha you need to start your research on right away.
Pull up NRSN right away.
NeuroSense Therapeutics is a clinical-stage biopharmaceutical company, focusing on the discovery and development of targeted innovative therapeutics for neurodegenerative diseases.
NeuroSense was founded in 2017 by Alon Ben-Noon, following a chance meeting with Shay Rishoni, an ALS patient. During this meeting, Alon was inspired by Shay, who served as the CEO of a non-profit organization for ALS. Despite Shay not having a physical voice, therefore communicating via eye movement and computer software, the connection was instant. Shay detailed his activities in the ALS field, and described the efforts that are being made to solve the ALS puzzle, leading Alon to team up with world-renowned scientists and colleagues in order to research and develop an effective drug for ALS patients, bringing about the establishment of NeuroSense.
To date, the company has commenced with a breakthrough treatment for ALS that will halt, or significantly delay disease progression, as well as developments for Alzheimer’s and Parkinson’s diseases.
We are focused on creating a combined therapeutic strategy, targeting multiple pertinent mechanisms in these complex diseases. Our research team and advisory board members are multidisciplinary professionals who have many years of experience with drug development and clinical programs, as well as personal connections to neurodegenerative diseases. Their collective expertise and background enable us to move in a fast and efficient manner to achieve our goals.
NeuroSense is currently conducting a phase 2b clinical trial using PrimeC in people with ALS. We also commenced research into other possible indications for the platform technology, including Alzheimer’s and Parkinson’s diseases. Additionally, our R&D team is studying the mechanisms of action and relevant biomarkers for these diseases.
NeuroSense’s novel drug, PrimeC, aims to treat ALS by regulating microRNA synthesis, reducing neuroinflammation, and influencing iron accumulation. PrimeC is a novel formulation composed of unique doses of two FDA-approved drugs, Ciprofloxacin and Celecoxib, which aim to synergistically inhibit the progression of ALS. The drug mitigates the degeneration and inflammatory response of motor neurons, and has significantly outperformed conventional treatments in a zebrafish model of ALS.
NeuroSense’s preclinical studies showed outstanding results in zebrafish models of ALS. PrimeC was shown to improve motor performance, and recover the morphology of motor neurons, neuromuscular junction structures, and microglial cells. Following these promising results, NeuroSense conducted two clinical trials which have shown that the drug is safe and tolerable, with promising clinical signs. PrimeC has received an orphan drug status from the FDA and EMA, and is currently preparing for a robust Phase 2b/3 clinical trial.
Due to the many shared pathways between neurodegenerative diseases, the hypothesis is that a disease-modifying drug for one, can lay the foundations for effective drugs for other neurodegenerative diseases. Therefore, we are working to develop a drug for Alzheimer’s based on the foundations of PrimeC. We have initiated the pre-clinical stage, testing CogniC in in-vitro models representing Alzheimer’s disease pathologies, and now initiating a phase 2 double blind placebo controlled study with 20 AD patients.
There are many shared pathways between Parkinson’s disease and ALS, such as neuroinflammation, protein aggregation, mitophagy, excitotoxicity, oxidative stress, iron accumulation, and dysregulation of miRNAs. Therefore, we are working to develop a drug for Parkinson’s based on the foundations of our drug, PrimeC, for ALS. We have initiated the pre-clinical stage, testing StabiliC in in-vivo models of Parkinson’s, assessing morphological and functional effects, exploring potential co-development with collaborators that have core focus in Parkinsons.
NRSN recently hit lows of .74 and EXPLODED off support
37.4% difference in ALSFRS-R in patients treated with PrimeC vs. placebo, demonstrating PrimeC’s potential to provide a meaningful clinical benefit to people living with ALS. https://t.co/279Kf8pIJ4
NeuroSense Partners with PhaseV to Optimize Upcoming ALS Phase 3 Trial Using Advanced Causal Machine Learning
PR Newswire
Tue, May 14, 20246 min read
PhaseV’s Causal Machine Learning Predicts High Probability of Success in Multiple ALS Subgroups for NeuroSense’s Phase 3 Trial
CAMBRIDGE, Mass., May 14, 2024 /PRNewswire/ — NeuroSense Therapeutics (Nasdaq: NRSN) (“NeuroSense”), a company developing novel treatments for severe neurodegenerative diseases, today announced that it partnered with PhaseV, a pioneer in causal machine learning (ML) for clinical trial analysis and optimization, with respect to the planned Phase 3 trial of PrimeC as a treatment for amyotrophic lateral sclerosis (ALS).As part of the collaboration, PhaseV conducted an independent analysis of NeuroSense’s PARADIGM Phase 2b study using a causal ML and predicts a high probability of success in multiple subgroups for the planned Phase 3 trial of PrimeC as a treatment for ALS. The external results provide important insights that will significantly inform study design, patient enrollment and ensure cost-effectiveness.”There remains a critical need for new innovative approaches to address this devastating neurodegenerative disease,” said Alon Ben-Noon, CEO of NeuroSense. “Our recently announced subgroup analysis from the PARADIGM study is very encouraging and suggests the potential of PrimeC to change this reality. Through our initial collaboration with PhaseV, we gained an even greater understanding of the effect of PrimeC across multiple patient subgroups. We will apply these insights to optimize the design of our Phase 3 study with the aim of maximizing meaningful clinical results that will differentiate PrimeC in the market. We plan to continue to collaborate with PhaseV as we develop our Phase 3 trial.”
NeuroSense Therapeutics recently reported positive efficacy and safety data from its Phase 2b trial (PARADIGM) with its lead drug candidate for ALS, PrimeC, and is planning on embarking on a Phase 3 pivotal trial in the next few months. In addition to PrimeC demonstrating a statistically significant 37% slowing of disease progression, as measured by the ALSFRS-R score (p=0.03), in the per-protocol population from the PARADIGM trial, it also announced a statistically significant slowing of disease progression in high-risk ALS patients treated with PrimeC by 43%(p=0.02) as compared to placebo in the pre-specified per protocol (PP) population analysis after 6 months of treatment. The slowing of disease progression demonstrated by PrimeC versus placebo translates to a 5.04 points difference in the ALSFRS-R in favor of PrimeC (Confidence Interval: 0.862, 9.214; n=38).High-risk patients, defined by the European Network for the Cure of ALS (ENCALS) Risk Factor as those with a higher risk for rapid disease progression, comprise approximately 50% of the total ALS population.
NeuroSense soon plans to submit its End of Phase 2 package to the FDA and EMA, including the updated Phase 3 study protocol, which will be discussed in the meetings.
“Although there is an improved understanding of the underlying mechanisms of ALS, therapeutic options remain limited due to the complexity and heterogeneity of the disease,” said Dr. Raviv Pryluk, CEO and Co-founder of PhaseV. “NeuroSense’s ALS drug candidate PrimeC showed great promise in its Phase 2b study. Through a unique combination of causal-ML, real-world data, and advanced statistical methods, we confirmed the potential clinical benefit of PrimeC and provided actionable insights for the Phase 3 study. Our analysis predicted a high rate of success for PrimeC in the Phase 3 clinical trial for multiple recommended subgroups.”
PhaseV’s proprietary technology addresses the challenges of drug development by providing tools for the identification of subgroups and endpoints most likely to succeed in subsequent clinical trials. This has helped companies to better understand how their drug candidates will perform in Phase 3 clinical trials and to optimize the design of the Phase 3 trial accordingly in order to achieve meaningful and successful outcomes.
NeuroSense Reports New Data: Statistically Significant Clinical Efficacy in Phase 2b ALS Trial
PR Newswire
Thu, Dec 14, 20236 min read
A statistically significant, 37.4% difference (P=0.03), slowing of disease progression in ALSFRS-R, in patients treated with PrimeC compared to placebo, in the pre-specified Per Protocol (PP) population analysis
Neurofilament biomarker results from Biogen collaboration expected in January 2024
Primary biomarker endpoints, TDP-43 and Prostagladin2, are expected in H1 2024
PrimeC’s meaningful effect magnitude, strong safety profile, and unique mechanism of action will be discussed with the FDA and other regulatory agencies in an End of Phase 2 meeting in H1 2024
CAMBRIDGE, Mass., Dec. 14, 2023 /PRNewswire/ — NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) (“NeuroSense”), a company developing treatments for severe neurodegenerative diseases, today reported additional positive efficacy data from further evaluation of its Phase 2b trial (PARADIGM) with NeuroSense’s lead drug candidate for amyotrophic lateral sclerosis (“ALS”), PrimeC.
Evaluation of the pre-specified Per Protocol (PP) population analysis of the recent top-line results from PARADIGM revealed a statistically significant slowing of disease progression with a 37.4% (p=0.03) difference in the gold standard ALS tracking measure, the ALS Functional Rating Scale-Revised (“ALSFRS-R”), in favor of PrimeC vs placebo, and 17.2% (p=0.39) difference in Slow Vital Capacity (“SVC”), in favor of PrimeC vs placebo. The PP analysis population includes all participants who adhered to the trial protocol and treatment plan without any major protocol deviations. The goal of a PP analysis in clinical trials is to assess the efficacy of a treatment under optimal conditions, thereby providing a clearer understanding of how well the treatment works when implemented as intended, contributing to a more comprehensive view of the trial results. PARADIGM’s PP population analysis is pre-defined in the trial’s statistical analysis plan, which includes 62 patients (43 active and 19 placebo) compared to 68 patients in the Intent to Treat (ITT) population (45 active and 23 placebo).
PARADIGM is a prospective, multinational, randomized, double-blind, placebo-controlled Phase 2b (NCT05357950) clinical trial. The trial’s primary endpoints include: safety and tolerability, and ALS-related biomarkers TDP-43 and Prostagladin2. The trial’s secondary endpoints include: clinical efficacy outcome measures, ALSFRS-R and SVC. ALSFRS-R is the most widely used ALS tracking tool accepted by the FDA, utilized by neurologists treating ALS patients, in clinical trials, and by other regulators to determine disease progression. It tracks 12 changes in a person’s physical abilities over time including functions such as: speech, walking, climbing stairs, dressing/hygiene, handwriting, turning in bed, cutting food, salivation, swallowing, and breathing. SVC is a measurement of respiratory function.While PARADIGM is powered to demonstrate statistically significant changes in the trial’s primary endpoints, the highly favorable clinical results seen in the PP analysis achieved an unexpected statistical significance.The new data reported today comes on the heels of recent positive top-line safety and efficacy data of PARADIGM announced by NeuroSense. An analysis of the ITT top-line data from the 6-month double-blind segment of the trial showed clinically meaningful signs of efficacy with a 29% difference in ALSFRS-R (p=0.12) and a 13% difference in SVC (p=0.5), both in favor of PrimeC vs placebo. These data include all 68 people living with ALS enrolled in Canada, Italy, and Israel, with the exclusion of one patient who was misdiagnosed. Most patients enrolled in both the active and placebo arms of trial were concurrently treated with Riluzole, the ALS standard of care medication, indicating PrimeC slowed disease progression well beyond the level afforded by the FDA approved ALS drug. In addition, the trial met its primary endpoint of safety and tolerability with results comparable to placebo, establishing a solid safety profile for PrimeC. 96% of the trial participants who completed the 6-month double-blind portion of the trial chose to receive treatment with PrimeC through a 12-month open label extension. Furthermore, to date, all participants that completed the 18-month trial treatment duration requested to continue taking PrimeC, which is provided to them via an Investigator Initiated Trial.NeuroSense expects to report results from a strategic collaboration with Biogen in January 2024, evaluating the impact of PrimeC on neurofilament levels in participants enrolled in PARADIGM. Upon receipt of results, Biogen has the right of first refusal to co-develop/ commercialize PrimeC for the treatment of ALS for a limited time following the results. The Company expects to report primary biomarker endpoints of ALS hallmarks TDP-43 and Prostagladin2, to evaluate PrimeC’s biological activity and target engagement, in the first half of 2024 following the completion of the analysis of participants’ plasma.An End of Phase 2 meeting with the FDA and a Scientific Advice meeting with European Medicines Agency (EMA) to discuss these results and to determine the best path forward for PrimeC’s development is expected in the first half of 2024.”As we analyze the PARADIGM trial results, we continue to gain a better understanding of PrimeC’s potential to render a significant and meaningful clinical benefit to people living with ALS. Today we are eager to share these new data with the ALS community, as we believe the PP analysis, demonstrating a statistically significant 37.4% difference in ALSFRS-R in patients treated with PrimeC vs. placebo, is an exceptional result,” stated Alon Ben-Noon, NeuroSense’s CEO. “This data, in conjunction with hopefully correlative neurofilament readouts, will create a regulatory opportunity to advance PrimeC’s development in a breakthrough manner toward the market.”About ALSAmyotrophic lateral sclerosis (“ALS”) is an incurable neurodegenerative disease that causes complete paralysis and death within 2-5 years from diagnosis. Every year, more than 5,000 patients are diagnosed with ALS in the U.S. alone, with an annual disease burden of $1 billion. The number of patients with ALS is expected to grow by 24% by 2040 in the U.S. and EU.About PrimeCPrimeC, NeuroSense’s lead drug candidate, is a novel extended-release oral formulation composed of a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib. PrimeC is designed to synergistically target several key mechanisms of ALS that contribute to motor neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid (“RNA”) regulation to potentially inhibit the progression of ALS. NeuroSense completed the 6-month double-blind portion of its Phase 2b ALS clinical trial which met its safety and tolerability endpoints, as well as showing a statistically significant slowing of disease progression in the pre-specified Per Protocol (PP) population. Additional data from the Phase 2b trial are expected H1 2024. PrimeC was granted Orphan Drug Designation by the U.S. Food and Drug Administration and the European Medicines Agency.
Mr. Ben-Noon is the Co-Founder and CEO of NeuroSense Therapeutics.
Prior to the establishment of NeuroSense, Alon founded MediCan Consulting, a successful consultancy firm, with clients from diversified biotech companies, including Mediwound, Chiasma, Teva, Sol-Gel, FutuRx, NeuroDerm and others. MediCan excelled at executing efficient, accurate, and innovative drug development programs for its clients.
Dr. Ferenc Tracik
Chief Medical Officer
Dr. Ferenc Tracik, our chief medical officer has twenty years of experience in general management, medical affairs, clinical development and commercialization in the biotech industry.
Before joining the Company, he served as the Global Head Medical of Orphazyme A/S. From May 2017 until November 2020, Dr. Tracik served as VP Medical Europe, Canada and Partner Markets of Biogen Inc. From November 2013 until April 2017, Dr. Tracik served in various positions at Teva Pharmaceutical Industries Limited, including Managing Director Specialty Medicines Germany.
Dr. Tracik’s experience and expertise in therapy is extensive, and includes different disease areas such as CNS, respiratory, oncology, ophthalmology, infectious diseases, and transplantation), with a specific focus on neurodegenerative and neuro-autoimmune diseases. Before joining pharmaceutical industry Dr. Tracik worked at the university clinics of neurology at Charité Berlin and the university clinic of Innsbruck. Dr. Tracik holds a doctoral degree in human medicine from the Free University of Berlin.
Dr. Niva Russek-Blum
Chief Technology Officer
Dr. Niva Russek- Blum has over 17 years of experience in neuroscience, specifically Parkinson’s disease and ALS.
Niva established her lab in 2012, leading research as a Principle Investigator under the auspices of Ben Gurion University, focusing on neurological and immune perspectives of neurodegenerative diseases.
She established a CRO, utilizing high throughput-screening infrastructure required for the evaluation of potential therapeutics, with broad expertise in microscopy, image and behavioral analyses.
Her work was published in established journals and she has actively organized and participated in worldwide conferences. Niva is experienced in raising funds from competitive granting agencies and the private sector, collaborations with major academia and biotech/pharma entities, managing strategic planning, recruiting and mentoring students and technical staff and cooperating with TTOs.
PhD in Neurobiology, from The Weizmann Institute.
Hagit Binder
Chief Operating Officer
Ms. Hagit Binder has over 13 years of experience in the drug development industry.
Previously, Ms. Binder held VP projects and a marketing position at Nextar Chempharma solutions.
She has led projects in various therapeutic areas for both local and global companies.
In addition, she oversaw all projects, was accountable for deliverables and adherence to timelines. She maintained long term relationships with stakeholders and negotiated to ensure alignment between expectations, quality and price.
Ms. Binder holds an M.Sc. degree in Biology and M.B.A degree from Bar Ilan University.
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Allocetra™ is being developed as an adjunctive therapy for preventing organ failure and mortality in sepsis, in combination with existing antibiotics agents
Favorable safety profile demonstrated across 140+ patients
Management team with a track record of creating shareholder value and getting drug products through marketing approvals globally in multi-billion dollar market segments
First patient dosed with AllocetraTM in thumb osteoarthritis, a degenerative, debilitating and progressive disease that affects millions of people-Thumb osteoarthritis currently has no FDA-approved therapy and no effective long-term treatment
Yesterdays profile continued to trade in the green after it was up double digits on strong interest during the session, 2 days in a row.
It broke yesterdays highs and ran through .42 during trading today.
We wanted to bring another company to your attention before the end of the week.
Pull up ENLV immediately.
This is a company that we have yet to feature on this newsletter.
Enlivex is at an advanced clinical stage, with Phase IIb trials for sepsis showing promise for a $33 billion market opportunity and Phase I/II trials in osteoarthritis aiming at a combined market opportunity of $9 billion. Additionally, the prospect of a short regulatory approval pathway in Europe for its sepsis treatment enhances the value proposition for investors. Enlivex’s strong leadership team, proven by their successful $560 million exit event with PROLOR Biotech and a significant partnership with Pfizer, underscores the company’s potential for high returns. With a robust cash balance and plain vanilla capital structure ensuring operational runway through the end of 2025 and a buy recommendation with a $12 per share price target, Enlivex stands out as a promising investment for investors seeking to capitalize on the next wave of innovations in immunotherapy and cell reprogramming technologies.
Allocetra™ is being developed as a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Diseases such as solid cancers, sepsis, and many others reprogram macrophages out of their homeostatic state. These non-homeostatic macrophages contribute significantly to the severity of the respective diseases. By restoring macrophage homeostasis, Allocetra™ has the potential to provide a novel immunotherapeutic mechanism of action for life-threatening and life-debilitating clinical indications that are defined as “unmet medical needs.”
While 55% of Americans have never heard of sepsis, it is the third leading cause of mortality in the United States following heart disease and cancer.
Sepsis is a highly heterogeneous syndrome that is caused by an unbalanced immune host response to an infection. The first use of the term ‘sepsis’ in a medical context was probably in poems by Homer that date from more than 2,700 years ago, but sepsis was not clinically defined until the early 1990s when a group of key opinion leaders released the first consensus definition of sepsis.
Herein, sepsis was defined as a systemic inflammatory response syndrome (SIRS) caused by an infection; increasing severities were designated ‘severe sepsis’ (referring to sepsis and organ dysfunction) and ‘septic shock’ (referring to sepsis and refractory hypotension).
In the most recent ‘Sepsis‑3’ consensus definition, sepsis is defined as a life-threatening organ dysfunction that is caused by a dysregulated host response to infection, and the term severe sepsis has been removed.
Of note, although infection is the triggering event in this definition of sepsis, the aberrant immune response often remains after successful treatment of the infection. Sepsis clearly imposes a substantial global burden in terms of morbidity and mortality. Nearly all patients with severe sepsis require treatment in an intensive care unit (ICU).
Sepsis, which has been identified by the World Health Organization (WHO) as a global health priority, has no proven pharmacologic treatment other than appropriate antibiotic agents, fluids, and vasopressors as needed. Reported death rates among hospitalized patients range between 30% and 45%, and one out of three patients who died in a U.S. hospital had Sepsis.
CLINICAL STATUS
On March 18, 2020, the Company announced the final safety and efficacy data from the Company’s completed Phase Ib. The final analysis compared the clinical data of 10 patients admitted to the intensive care unit with sepsis who were administered Allocetra™ upon their admission, with 37 patients who were matched controls (matched by age, gender, Sequential Organ Failure Assessment (SOFA) score, and infection source) who received only the standard of care treatment at the same hospital during 2014-2019 but did not receive Allocetra™. The clinical trial was conducted at Hadassah Medical Center, which is one of the largest and most prestigious hospitals in Israel (“Haddasah”). The Acute Physiology and Chronic Health Evaluation (APACHEII) score of the Allocetra™-treated group was 12.3, and the corresponding probability of mortality of at least one patient in that group was predicted at 85% based on the hospital’s ICU staff’s clinical assessment of each patient’s overall condition at admission. However, none (0%) of the Allocetra™-treated patients died during the 28-day study period, as compared to 27% 28-day mortality in the matched controls group. Each of the 10 Allocetra™-treated patients had between 2 to 5 dysfunctional organ systems upon admission to the ICU. All (100%) of the Allocetra™-treated patients had rapid and complete recovery from their septic conditions and of any organ dysfunction that was present upon admission to the ICU. Despite the similarity of organ-failure state (SOFA) at entry between the Allocetra™-treated patients and the matched controls group (average of 3.4 versus 3.47), not a single patient treated with Allocetra™ had any increase in organ-failure state post administration of Allocetra™, while the majority of the patients in the matched controls group had an increase in organ-failure state. The average worsening in organ-failure state of patients in the matched controls group was approximately 100% compared with their ICU hospitalization state vs zero (0%) percent worsening in organ-failure state of Allocetra™-treated patients post administration of Allocetra™ (p< <0.0001). The ICU length-of-stay for all Allocetra™-treated patients was significantly shorter than those patients who received only the standard of care, with an average of 4 days compared to 11.11 in the matched controls group, a 64% reduction (p<0.0001). The slowest ICU discharge of a patient treated with Allocetra™ was after 8 days, while approximately 50% of the matched controls group were still at the ICU after 28 days. Allocetra™ was shown to be safe and tolerable, with no serious unexpected severe adverse reactions and no serious adverse events.
Summary of Planned Clinical Trials of Allocetra™ for the treatment of Organ Dysfunction and Failure Associated with Sepsis
In light of the encouraging results of the Phase Ib in patients with severe sepsis, the Company has initiated a Phase II clinical trial, which is currently ongoing. The company intends, subject to clinical trial outcomes, to submit a conditional marketing authorization application to EMA for this indication.
Enlivex Announces the Dosing of the First Patient in a Randomized, Placebo-Controlled Phase I/II Trial Evaluating AllocetraTM in up to 46 Patients with Thumb Osteoarthritis
PUBLISHED
JUN 24, 2024 8:00AM EDT
First patient dosed with AllocetraTM in thumb osteoarthritis, a degenerative, debilitating and progressive disease that affects millions of people
Thumb osteoarthritis currently has no FDA-approved therapy and no effective long-term treatments
Ness-Ziona, Israel, June 24, 2024 (GLOBE NEWSWIRE) — Enlivex Therapeutics Ltd.(Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that the first patient has been dosed in an investigator-initiated, randomized, placebo-controlled Phase I/II trial evaluating the efficacy and safety of Allocetra™ following injection into patients with basal thumb joint (first carpometacarpal (CMC) joint) osteoarthritis, for which conventional therapies have failed.
This investigator-initiated Phase I/II trial plans to recruit up to 46 patients and is composed of two stages. The first stage is a safety run-in, open-label dose escalation phase to characterize the safety and tolerability of an AllocetraTM injection in patients with osteoarthritis of the first basal thumb joint (first CMC joint) of the target thumb to identify the dose for the randomized stage. The second stage is a double-blind, randomized, placebo-controlled stage, which the Company expects to initiate following the completion of the safety run-in stage and selection of the safe and tolerable dose. Up to 40 patients will be randomized in a 1:1 ratio for treatment with either AllocetraTM at the selected dose or placebo. The primary safety endpoint will measure the frequency and severity of adverse events and serious adverse events, and the efficacy endpoints will include assessments of change from baseline in pain and function for up to 12 months following treatment.
“This is the first injection of AllocteraTM into the basal thumb joint, and we are pleased with the swift enrollment of the first patient just a few weeks following regulatory approval to initiate this trial. The injection of AllocteraTM into the patient’s basal thumb joint was successfully completed with no complications.” stated Oren Hershkovitz, Ph.D., CEO of Enlivex.
ABOUT BASAL THUMB OSTEOARTHRITIS
Osteoarthritis of the thumb is a chronic condition causing pain, stiffness and occasional clicking and swelling in the joint at the base of thumb (also known as the carpometacarpal or CMC joint). Simple daily tasks can become painful and difficult. The prevalence of thumb osteoarthritis increases substantially with age and is more common in postmenopausal woman. The prevalence of radiographic base thumb OA was reported to be 5.8% and 7.3%, for 50-year-old males and females, respectively, while the respective prevalence for 80-year-old male and female participants was reported as 33.1% and 39.0%1. The overall estimated symptomatic prevalence is up to 15% in adults over 30 years of age2. Osteoarthritis of the thumb is a degenerative and progressive condition, and over time, conservative treatments and anti-inflammatory medication to reduce pain and swelling start losing their effectiveness. Currently, there are no effective long-term treatments for this disease.
Enlivex Announces Topline Results of Its Phase II Trial Evaluating Allocetra™ In Patients With Sepsis
PUBLISHED
APR 11, 2024 8:05AM EDT
Analysis of eligible1 patients from the sepsis Phase II study (NCT# NCT04612413)
In accordance with the study protocol, the safety and efficacy topline analysis includes sequential organ failure assessment (SOFA) scores and mortality for the 28-day period post treatment.
Efficacy:
Stand-alone analysis of the Allocetra™-treated patients, of which 78% had septic shock and 65% had invasive ventilation at screening, demonstrated substantial reductions in SOFA scores and 65% reduction in overall mortality rate as compared with expected mortality2. By day 28, the analysis showed 90% reductions of SOFA scores for sepsis patients whose infection source was urinary tract, 68% for patients whose infection source was community-acquired pneumonia, and 36% for patients whose infection source was internal abdominal infection.
Relative analysis demonstrates a potential indication of effect of Allocetra™ as compared with placebo in high-risk, severe sepsis patient population (organ failure scores >=7), originating from urinary tract infections (“High Risk UTI”). Enlivex intends to consider a potential follow-on, randomized, controlled study of a solely High Risk UTI sepsis population. Up to 31% of sepsis cases start as urinary tract infections, representing up to 9.8 million cases in the United States and Europe, leading to as many as 1.6 million deaths3, and represents a substantial potential market opportunity for Allocetra™.
The study was designed for patients to be randomized with equal degree of SOFA scores across treatment and placebo groups. The randomization resulted in the Allocetra™-treated cohorts having 20% higher frequency of septic shock and 35% higher frequency of invasive ventilation prior to treatment, as compared with the control group. Both of these patient attributes are associated with a significantly higher degree of difficulty of treatment and higher mortality rates. These imbalances made it challenging to deduce the relative effect in other patient subgroups.
Safety: Stand-alone and placebo-compared analysis across all sepsis patient subgroups and risk categories demonstrated acceptable safety and tolerability profile of Allocetra™ IV infusions.
Nes-Ziona, Israel, April 11, 2024 (GLOBE NEWSWIRE) — Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced positive indication of effect and safety results from its Phase II study of Allocetra™ in patients with sepsis, in which 120 patients enrolled. Bruno François, M.D., intensive care physician, is the head of the Limoges Clinical Investigation Center (Limoges, France). Dr. François took a primary role in the design of the study, medical support and oversight of patient eligibility. Dr. François was the national coordinator for numerous emergency trials, especially in sepsis, and has participated in several advisory boards for sepsis multinational trials, independent clinical evaluation committees and adjudication committees. Dr. François stated, “I am very excited about Allocetra’s™ novel approach, using a first-in-class innovative cell therapy to explore the treatment of patients with acute, life-threatening sepsis and septic shock. The study, a randomized controlled trial conducted in six countries and multiple clinical centers, demonstrated a favorable safety profile for Allocetra™. Within the context of the study, we also learned the ease of use and feasibility to infuse Allocetra™ cells to patients even in the complex setting of the intensive care unit. The study was well designed and executed, although randomization resulted in the Allocetra™-treated cohorts having higher frequencies of septic shock and invasive ventilation prior to treatment, as compared with the control group. Because these patient attributes are typically associated with a significantly higher degree of difficulty of treatment and higher mortality rates, the relative effect of Allocetra™ in some patient sub populations was challenging to deduce. I am pleased with the unusually low mortality rates across the board in the study, and that Allocetra™ demonstrated a potential indication of effect in high-risk sepsis patients originating from urinary tract infections. A substantial number of sepsis cases originate from urinary tract infections, and we have been actively searching for additional treatment alternatives for those patients, especially those who are at high risk. Having reviewed the topline study results, I look forward to reviewing the forthcoming additional safety and biomarker data of patients in the study, and I recommend the further exploration of the use of Allocetra™ in the High Risk UTI population.”Oren Hershkovitz, Ph.D., CEO of Enlivex said, “We are pleased with the demonstration of substantial SOFA score reductions and low mortality rate of the Allocetra™-treated patients across all origins of sepsis in the study, the indication of effect compared with placebo for the high-risk patients whose sepsis originated from urinary tract infections, and the favorable safety profile of Allocetra™. The Company intends to consider, upon reviewing the totality of the data, a potential follow-on, randomized, controlled study of a solely High Risk UTI sepsis population. Up to 31% of sepsis cases start as UTIs4, and this represents a substantial potential market opportunity for Allocetra™. The randomization resulted in the Allocetra™-treated cohorts having 20% higher frequency of septic shock and 35% higher frequency of invasive ventilation prior to treatment, compared with the placebo group. Both of these patient attributes are associated with significantly higher degree of difficulty of treatment and higher mortality rates, and potentially resulted in patients with more severe sepsis in the Allocetra™-treated cohorts. These biases made it challenging to deduce the relative effect in other patient subgroups.”
ABOUT UTI Urinary tract infection (UTI) is the second most common infectious disease affecting more than 150 million people globally annually. Up to 31% of sepsis cases start as UTIs, representing up to 9.8 million cases in the United States and Europe, leading to as many as 1.6 million deaths4.
ABOUT THE PHASE II SEPSIS CLINICAL TRIAL(NCT# NCT04612413) The Phase II trial was a placebo-controlled, randomized, dose-finding, multi-country, multi-center study, evaluating frozen-formulation Allocetra™ in addition to standard of care in patients with sepsis associated with pneumonia, biliary, urinary tract, or peritoneal infections. The results contained in this press release represent topline data and are subject to revision based on the ongoing collection of study information and detailed analysis. The Company expects to release further details about the study in a forthcoming presentation.
ABOUT ALLOCETRA™ Allocetra™ is being developed as a universal, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. Diseases such as solid cancers, sepsis, and many others reprogram macrophages out of their homeostatic state. These non-homeostatic macrophages contribute significantly to the severity of the respective diseases. By restoring macrophage homeostasis, Allocetra™ has the potential to provide a novel immunotherapeutic mechanism of action for life-threatening clinical indications that are defined as “unmet medical needs”, as a stand-alone therapy or in combination with leading therapeutic agents.
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We have another profile that we want you to research for tomorrows session.
This is a company that we have profiled many times over the past few years.
Most notably, we sent out emails and texts on March 21st when it opened up at .22 after a gap up in the am.
In less than 3 weeks this one exploded all the way up to .90 for a 300%+ move.
You can see it right there on the chart below.
Since then it has pulled back and it looks to have established new trading range.
KULR Technology Group Inc (NYSE: KULR) develops and commercializes high-performance thermal management technologies for batteries, electronics, and other components across an array of battery-powered applications. As the global economy becomes increasingly electrified and connected, KULR is addressing the rising demand for cooler, lighter, and safer batteries, and electronic systems. Leveraging the company’s roots in developing breakthrough cooling solutions for NASA space missions and backed by a strong intellectual property portfolio, KULR provides customers with industry-leading battery safety technologies as well as cost-effective cooling technologies that outperform traditional solutions. The world’s leading aerospace, electronics, energy storage, 5G infrastructure, and electric vehicle manufacturers trust KULR to solve safety, reliability, and efficiency challenges in an ethical and environmentally sustainable manner.
Active government initiatives propelled by industry and regulatory tailwinds are increasing demand for battery recycling and clean energy, resulting in an expanding total addressable market for KULR’s solutions. The Company’s disruptive technologies strive to fulfill an addressable $24 billion thermal management systems market (estimated based on market data projections published by Converged Markets stating that the thermal management systems market size was projected to grow from $11.1 billion in 2017 to $24.8 billion by 2025. KULR’s integrated design approach offers comprehensive solutions in thermal interface materials, lightweight heat exchangers, and protection against lithium-ion battery thermal runaway propagation. Its high-performance solutions can be designed to fit demanding configurations and applications.
As companies and governments around the world pledge to meet net zero emissions over the next few decades, KULR is uniquely positioned to accelerate the adoption of clean energy solutions and sustainable products and facilitate the migration to a global circular economy. The Company’s goal is to provide total battery safety solutions for more efficient battery systems, increased sustainability, and end-of-life battery management, making KULR a key technology solutions provider in the migration to a global circular economy.
CATALYSTS
Leveraging KULR’s roots in developing breakthrough cooling solutions for NASA space missions and backed by a strong intellectual property portfolio, KULR provides customers with industry-leading battery safety technologies as well as cost-effective cooling technologies that outperform traditional solutions.
KULR is currently processing up to 10,000 lithium-ion cells per week as well as preparing for tests performed by NASA, the Department of Defense (“DoD”), and others performing manned flighted missions.
KULR was awarded three additional contracts with DoD prime contractors to implement the Company’s carbon fiber cathode solution for high-power magnetic and other covert pulse weaponry initiatives.
KULR also secured a new battery safety contract with NASA to test its lithium-ion cells for future battery packs designed for the Artemis Program, a series of US-led international human spaceflight programs.
KULR recently appointed former NASA Johnson Space Center senior leader Dr. William Walker as Director of Engineering.
KULR expects to procure lithium-ion battery cells providing up to 500-megawatt hours (“MWh”) of energy capacity, enough to power approximately 40,000 homes.
KULR just received a follow-on phase change material heat sink order from Lockheed Martin
KULR has partnered with Lockheed Martin, Leidos and other prime contractors to develop and supply mission-critical technologies for hypersonic vehicles, high-power magnetic wave, and other defense systems.
KULR’s portfolio of thermal management solutions target air and liquid-cooling of high-performance computing applications such as crypto mining, cloud computing, AI, and AR/VR simulations to maximize performance, energy efficiency and safety.
KULR TECHNOLOGY GROUP REPORTS RECORD ANNUAL REVENUE FOR 2023
Full-Year 2023 Revenue Up 146% Year-Over-Year
SAN DIEGO / GLOBENEWSWIRE / April 12, 2024 / KULR Technology Group, Inc. (NYSE American: KULR) (the “Company” or “KULR”), a global leader in sustainable energy management, today announced its financial results for full-year 2023.
Full-Year 2023 Financial Results:
Revenues: Revenue increased 146% to $9,830,166 in 2023 from $3,994,634 in 2022. The increase in revenue was mainly due to early success in the energy storage and battery transportation and recycling sectors. The Company continues to build its relationships with a wide range of energy, transport and aerospace partners and has billed 53 customers during the year ended December 31, 2023, a 47% increase from 36 billed customers during the year ended December 31, 2022. These additions reflect management’s commitment to build new customer relationships through a growing pool of referrals and business development leads.
Selling, General and Administrative (SG&A) Expenses: SG&A expenses increased to $19,882,402 in 2023 from $16,453,776 in 2022. The 21% increase was primarily due to increases in labor costs, and depreciation and amortization expenses due to expansion of our facility and equipment placed in service during 2023.
R&D expenses: R&D expenses in 2023 increased to $6,195,400 from $4,196,313 in 2022, reflecting an increase in employee headcount in order to build future capacity, and R&D initiatives designed to build future revenue growth.
As of December 31, 2023, the Company had 57 full time employees and 3 contractors compared to 62 full time employees and 16 contractors on December 31, 2022.
Net Loss: Net loss for 2023 increased to $23,693,556 or a loss of $0.20 per share, compared to $19,436,479 or a loss of $0.18 per share in 2022.
Cash Position: The Company reported cash balances of $1,194,764 as of December 31, 2023, compared to $10,333,563 as of December 31, 2022.
Recent Corporate Highlights:
Revenue has grown at a compound annual growth rate of 102% from 2021 through 2023. ㅤ
Secured a commitment exceeding $1 million with H55 Inc., a pioneer and global leader in electric propulsion. H55 will employ KULR’s unique Thermal Runaway Shield within its propulsion systems that equip fleets of industry behemoths such as Pratt & Whitney and CAE Inc. Embedding KULR’s TRS into H55’s Electrical Propulsion System (“EPS”) is critical for aligning with the European Union Aviation Safety Agency (“EASA”) safety protocols. ㅤ
Secured a pivotal contract exceeding $865,000 from Nanoracks (now part of Voyager Space’s Exploration Segment). Based in Webster, Texas, Voyager’s Exploration team is a prominent provider of commercial space services, specializing in satellite deployment, space station research, and the development of space habitats. The contract underscores KULR’s role in spearheading the accelerated development, testing and early production of a specialized space battery, aimed at enhancing Voyager’s CubeSat applications. ㅤ
Received a six-figure contract from Lockheed Martin for developing phase change material heat sinks that are pivotal for the thermal regulation of essential electronics within long-range precision missiles. This achievement follows a series of successful evaluations that showcased the efficiency of KULR’s solutions in cooling critical onboard systems. ㅤ
Received an initial purchase order from one of the world’s largest privately held space exploration companies for enhanced battery safety testing solutions, using the Company’s KULR ONE Design Solutions (“K1-DS”) platform. The proprietary K1-DS platform incorporates the most comprehensive design and testing methodology for battery safety. Though specific terms of the contract remain confidential, the customer has publicly forecasted a substantial ramp-up in its planned space missions as it continues to scale its satellite deployment throughout 2024. ㅤ
Confirmed collaboration with a leading U.S. automaker focusing on mitigating thermal runaway risks in EV battery modules through KULR’s advanced SafeCASE™ technology. This project underscores KULR’s commitment to safety and innovation in the rapidly growing electric vehicle market. ㅤ
Engaged by one of the few global leaders in space travel to design, develop, and deliver battery systems tailored for the rigorous demands of space travel. These batteries will power the dramatically growing commercial space business for KULR’s partner for its immediate needs and into the future. The commercial, economic, and mission-critical requirement for on-time delivery of consistently safe, reliable, and efficient battery power solutions coupled with the complex demands of space travel led this customer to KULR. While the program is already underway, upon achieving anticipated milestones, both KULR and its partner anticipate follow-on orders supporting a significant increase in the frequency and scale of planned space missions. ㅤ
Secured new special permits from the United States Department of Transportation related to its patented SafeX product suite, including SafeCASE™ and SafeSLEEVE™. The recently granted Special Permit 21693 and Special Permit 21704 cover transportation of damaged, defective, or recalled (“DDR”) batteries as well as end-of-life batteries to include the critical area of battery disposal and recycling, paving the way for safer and more sustainable battery recovery and reuse practices. The new special permits are expected to generate additional opportunities for KULR with both existing and new customers in various industries.
Energy Storage
The U.S. doubled its energy storage capacity in 2021 and is expected to increase 17x by 2030, according to Wood Mackenzie. Lithium-ion batteries are the dominant technology on the market for energy storage because of their cost and availability but do carry well documented safety risks. While rare, cell to cell thermal runaway in lithium-ion batteries can cause a fire or explosion. For example, an explosion at Arizona Public Service’s McMicken battery plant injured four emergency responders in 2019 and overheating caused the 1.2 GWh Moss Landing storage facility in California to go off-line. To reach net zero by mid-century will require an additional 245 GWh of battery capacity each year until 2030, but incidents of the like distill trust in battery technologies and threaten to slow the pace which is needed to achieve decarbonization goals. KULR’s passive propagation resistant (PPR) and thermal runaway shield (TRS) technologies prevent cell to cell thermal runaway propagation and inhibit fire and ejecta of a single cell from exiting the battery enclosure, making battery energy storage packs safe for homes, hospitals, schools, and universities, and more. KULR is partnering with leaders in the energy storage industry such as Volta Energy Products, the subsidiary of Buffalo NY based parent company, Viridi Parente, to increase deployments of safe, reliable, and durable energy storage safety systems to accelerate the broader energy transition.
Battery Recycling and Management
KULR-Tech Safe_Case provides a safe and cost-effective solution to commercially store and transport lithium batteries, which is increasing in frequency as supply chain challenges and ESG commitments necessitate battery recycling and end-of-lifecycle management. Whether shipping a single battery, a battery-powered device or a load shipment of batteries, KULR’s technology mitigates the impacts of cell-to-cell thermal runaway propagation and ensures a safe journey. KULR’s Thermal Runaway Shield (TRS) technology is trusted by NASA to ship and store astronauts’ laptop batteries on the International Space Station. In addition, KULR combines its Passive Propagation Resistant (PPR) solutions with its new CellCheck intelligent battery management system to extend battery life. The CellCheck modular battery management system platform is KULR’s AI-powered battery safety technology for e-mobility, energy storage and fleet applications. It captures real time and lifetime battery intelligence, sensing adverse electrical, environmental, and physical events to analyze and control for maximum battery safety, reliability, and performance. As commercial industries across the board face greater scrutiny to comply with ESG standards, KULR is serving a total addressable market for a circular economic model for batteries that will reach over $21 billion by 2025 (estimated based on market data projections published by Grand View Research, Inc. stating that the global battery recycling market size is expected to reach $21.04 billion by 2025).
E-mobility
KULR is supporting the shift to electrified transport by enabling safer, lighter, and faster charging lithium-ion batteries for electric vehicles and micro mobility solutions.KULR’s passive propagation resistant (PPR) battery pack solutions increase battery energy capacity while preventing thermal runaway events that can lead to hazardous explosions, helping the transportation industry to address growing public safety concerns around electric vehicles, electric aviation and micro-mobility markets.
Vehicle technology advancements and EV range anxiety requires more battery capacity to expand the range and power of existing platforms while adding new, power-demanding components for advances such as 5G data networks. The additional strain on batteries increases the risk for overheating and serious failures and can damage sensitive chip architecture. In addition, overheating has been a key limiting factor for advancing fast charging battery technology. KULR’s carbon fiber thermal management technologies reduce the thermal resistance inside battery cells while increasing electrical conductivity to dissipate heat more efficiently to enable the safe deployment of fast charging batteries. With KULR, automotive OEMs and battery manufacturers can increase the energy capacity of battery cells so less cells are needed, making for lighter vehicles that drive further before needing to be charged.
Aerospace/Defense
KULR’s thermal management solutions enable the defense and aerospace industries to safely deploy electronic technologies that support critical missions and protect national security.Technology in this sector is developing at increasing rates – the space industry alone will be worth nearly $3 trillion in 30 years. The electronic devices being placed into aircrafts, satellites, and missiles are becoming ever smaller and more powerful. Lithium-ion batteries, which are already prone to overheating and propagation, are exposed to harsh thermal environments as well as shock and vibration during aerospace and defense operations. KULR has partnered with Lockheed Martin, Leidos and other prime contractors to develop and supply mission-critical technologies for hypersonic vehicles, high-power magnetic wave, and other defense systems.
High-Powered Computing & 5G
Demand for improved, cost-effective cooling solutions in the rapidly growing 5G and cloud computing industries is ever-increasing. KULR’s portfolio of thermal management solutions target air and liquid-cooling of high-performance computing applications such as crypto mining, cloud computing, AI, and AR/VR simulations to maximize performance, energy efficiency and safety. KULR’s proprietary carbon fiber-based suite of thermal interface materials leverage advanced carbon fiber based heatsink technology that offers customers highly customizable, lightweight, and cost-effective solutions with industrial-level reliability due to their high thermal conductivity, lightweight, and low contact pressure.
New Battery Cell Development
KULR started a research and development initiative using carbon fiber structures to produce battery cells with higher energy density and faster charging capabilities. Fast-charging will be the killer app for next-gen batteries. Right now, overheating is a key limiting factor in advancing fast-charging battery technology. There may be a way to solve that problem by using carbon fiber inside the battery cell to reduce thermal and electrical resistance which can dissipate heat more effectively. The R&D initiatives include thicker cathode with higher loading factor, silicon anode, lithium metal anode and solid-state electrolyte development. This is a long-term strategic development for KULR.
Commercial Partnerships
KULR has a long-term technology and developmental partnership with Andretti Technologies (ATEC), the advanced technology arm of racing team Andretti Autosport. The alliance will establish a thermal management testing and design platform for high-performance battery solutions with the highest safety ratings that will be adapted to the technical requirements of Andretti’s racing enterprise with the goal of transferring solutions to mass-market electric vehicle (EV) applications.
New Facility and IT-Systems
KULR relocated in October 2021 to a new facility located at 4863 Shawline St, San Diego, CA. The facility is 3 times larger than the previous facility with adequate room to support the Company’s new automated battery cell testing capability that will launch in Q322 as well as personnel growth. Additionally, the Company installed independently enclosed areas to support the machine shop, testing lab, battery lab, and Fiber Thermal Interface Material (“FTI”) manufacturing lab. KULR has implemented a 5S standard for the entire facility and will seek ISO 9001 certification in June 2022.
KULR has engaged with Managed Solutions to enhance its IT infrastructure and improve all aspects of Cyber Security. As a sub-contractor for DOD programs, it was vital that KULR have state of the art IT systems and controls. The Company believes the best path based on the current scale of the company is to outsource this activity to a professional IT services organization. The result of this activity was an improvement of our NIST score of over 140 points.
EVOLUTION OF KULR
*** KULR PCM heat sink technology inside the International Space Station (ISS) Nicer telescope. (2016)
*** NASA testing of KULR TRS battery heatsink is best-in-class. KULR awarded contract in upcoming Mars 2020 Rover mission. Exclusive worldwide commercial license of NREL ISC testing device. (2017-2018)
*** KULR partners with Lockheed Martin to provide Thermal Management Solution (2018)
*** Product development with world-class partners and start of business expansion with focus on E-mobility and Battery Safety Markets. (2019)
*** KULR Technology partnership with Leidos to supply NASA with Lithium-ion Battery Storage Solutions for the International Space Station. (2020)
KULR Experiences Fast-Growing Demand for Next-Gen EV Battery Safety and Testing Solutions with Order from Top Japanese Automaker
PUBLISHED
MAY 29, 2024 8:30AM EDT
Battery Testing and Analysis Services Unit to Generate $8 Million to $10 Million Revenue Annually Starting in 2025
SAN DIEGO, May 29, 2024 (GLOBE NEWSWIRE) — KULR Technology Group, Inc. (NYSE American: KULR) (the “Company” or “KULR”), a global leader in sustainable energy management, today announced it has secured a contract from a top Japanese multinational automaker (“Automaker”) for testing and analysis of high-energy battery cells intended for their next-generation electric vehicles. The Company will utilize its KULR ONE Design Solutions (K1-DS) platform to expedite design readiness for the Automaker’s future electric vehicle buildout.
KULR’s extensive spaceflight expertise and proprietary KULR ONE Design Solutions are integrated into its rigorous testing protocols, forming what KULR believes to be the world’s most comprehensive battery safety testing platform. These tests encompass Fractional Thermal Runaway Calorimetry (“FTRC”), bomb calorimetry, and impingement zone mapping, providing unparalleled cell-level characterization and insights to optimize battery safety.
Originally, K1-DS was developed to introduce customers to KULR products, with the goal of transitioning to volume production. While this remains the Company’s core objective, over time KULR has expanded its testing services, projecting it to become an annual $8 to $10 millionrevenue standalone business starting in 2025, without additional investment in testing capabilities.
New K1-DS contracts are in progress as KULR recognizes design services as a high-margin, recurring revenue stream, with the automotive sector being a prime target for ongoing business. This demand is largely driven by electric vehicle manufacturers’ continuous evaluation of next-generation cells for improved efficiency and faster charging times. According to last year’s International Energy Agency’s projection, electric vehicles, including fully electric and plug-in hybrid models, are expected to account for 35 percent of new vehicle sales worldwide by 2030. The Company expects the FTRC to remain widely used across various industries for assessing both current and future cell technologies.
KULR Technology Group Lends Battery Production Infrastructure for Rapid Support of NASA’s R5 Program
PUBLISHED
MAY 2, 2024 8:30AM EDT
KULR’s New Texas Battery Center of Excellence Facility Demonstrates Fast Turn-Around Timefor Customers
SAN DIEGO, May 02, 2024 (GLOBE NEWSWIRE) — KULR Technology Group, Inc. (NYSE American: KULR) (the “Company” or “KULR”), a global leader in safe and high-performance energy storage solutions, today announced the Company recently leveraged its battery production capabilities at its newly instituted Webster, Texas facility to support NASA with rapid technical aid and production assistance to help prepare the administration’s R5 flight battery for its quickly approaching Firefly mission. R5, or “Realizing Rapid, Reduced-cost high-Risk Research”, refers to CubeSats designed to operate in Low Earth Orbit (“LEO”) at an affordable cost.
Project objectives require the R5 teams to rely on commercial-off-the-shelf (“COTS”) components whenever possible. More information about the R5 program and its strategy can be found here. A recent round of testing revealed that the battery design required a more robust electrical interconnect (busbar) to supplement the COTS nature of the design. Within six hours of engagement, the KULR team was able to provide NASA’s R5 Team with a solution which successfully passed additional testing the following week. This engagement in particular highlights the collaborative spirit and mindset that drives the Company’s Webster, Texas facility where the singular goal is to provide rapid turnaround energy storage solutions, whether it be for KULR’s commercially marketed KULR ONE Space platform or something entirely customized, such as NASA’s R5 program. KULR’s current facility infrastructure was designed and built upon a goal of providing a holistic approach to battery design in the form of KULR ONE Design Solutions (K1-DS). With K1-DS, KULR can provide in-house and custom battery (1) Design, (2) Testing Services, (3) Analysis/Modeling, (4) Abuse Testing, (5) Cell-Level Characterization and Cycling, (6) Fabrication, and (7) Production Services, all in-one-shop.
Lithium battery technology has been utilized in satellites for over two decades, enhancing mission calendar life, reducing weight, and lowering total cost of ownership for satellite manufacturers and operators. As satellite manufacturers prioritize reduced size and costs, they are consistently seeking advancements in battery technology that offer lighter weight, longer lifespan, and enhanced safety. KULR’s comprehensive services, coupled with rapid response turnaround, uniquely position the Company to provide battery solutions for the space industry.
As the space sector enters a new era, the space economy is projected to reach $1.8 trillion by 2035, driven by the increasing prevalence of satellite and rocket-enabled technologies. This forecast comes from a recent collaborative report by the World Economic Forum and consultancy firm McKinsey & Company.
The KULR team, which maintains around-the-clock preparedness for rapid turnaround engagements such as the R5 program, continues to keenly focus on in-progress programs including, but not limited to, previously announced Army DEVCOM engagements (categorized as KULR ONE Guardian), expansion of the KULR ONE Space (K1S) portfolio into the CubeSat and SmallSat markets, customized battery design activities, and preparedness for low volume but high technical niche battery production. Additionally, KULR is currently relocating all abuse testing services to its Webster, Texas facility while expanding overall testing capacity by threefold.
William Walker, KULR CTO, stated, “The mission of KULR is bold and is more than just developing next generation energy storage systems. We aim to flip the script for how batteries are designed and what development timelines and costs customers can expect for both custom and semi-custom packs. What we are accomplishing in Webster, Texas exemplifies our execution towards accomplishing that mission. We look forward to adding additional capabilities to the facility soon, and more importantly, we look forward to continued customer engagements where we will focus on providing custom-designed KULR ONE solutions.”
ULR Technology Group and Amprius Technologies Form Strategic Partnership for Advanced Battery Packs
PUBLISHED
KULR ONE Space and KULR ONE Guardian Platforms to Integrate Amprius Silicon Anode SA10 Cells
SAN DIEGO, April 30, 2024 (GLOBE NEWSWIRE) — KULR Technology Group, Inc. (NYSE American: KULR) (the “Company” or “KULR”), a global leader in safe and high performance energy storage solutions, today announced a leap forward in battery technology tailored for defense and space applications as KULR Technology Group (NYSE: KULR) and Amprius Technologies (NYSE: AMPX) officially announce their strategic partnership. This collaboration heralds the integration of Amprius’ innovative high performance cylindrical cell into KULR ONE Space and Guardian battery architectures, renowned for their high reliability and robust safety protection, for aerospace and military applications. At the heart of this partnership is Amprius’silicon-anode SA10 cells, which are set to provide a tactical edge through superior energy density and discharge capability. The incorporation of these cells into KULR ONE Space & Guardian reference designs will ensure a propagation-resistant structure, equipped with the necessary safety measures to meet stringent specifications for defense and space operations.
KULR Technology Group is poised to incorporate these cutting-edge cells into forthcoming standard battery models like the BB 2590 and into commercialized variations of the KULR ONE Space 100 to 400 Wh variations, harnessing our NASA-certified screening practices, or similar, to bolster safety. This crucial step meets a fundamental requirement for battery packs destined for crewed space flights, in compliance with the NASA JSC 20793 standard and for next generation military battery packs required to satisfy extensive environmental testing requirements such as MIL-STD-810H. Working jointly with Amprius and NASA, KULR is committed to securing the essential approvals for the SA10’s use in battery packs for these vital missions and applications.
A recent collaborative report by the World Economic Forum and consultancy firm McKinsey & Company highlights the potential of the global space economy to address major industry and societal issues. The report forecasts that by 2035 the sector’s valuation could reach $1.8 trillion, putting it on par with the influential semiconductor industry. The study envisions space technologies becoming as integral to daily life as semiconductors are currently, driven primarily by advancements in communications positioning, navigation and timing, and Earth observation services.
KULR CEO Michael Mo remarked, “The innovation encapsulated within the SA10 cell, and the agility demonstrated by Amprius align seamlessly with our commitment to serving high reliability sectors. This is an ideal strategic partnership for our KULR ONE platform utilizing their high energy density cell. Together, we are positioned to exceed the expectations of our mission-critical customers.”
Amprius Technologies’ CEO Dr. Kang Sun praised the alliance, stating, “KULR’s unwavering dedication to safety and innovation, coupled with their ability to rapidly produce prototypes, is indispensable. KULR’s adoption of Amprius’ industry-leading cell based on the SiCore™ product line not only allows us to enter new markets with cutting-edge technology, but it also propels ongoing development for future demands.”
This strategic partnership sets a new standard for battery solutions in high-stakes environments, reflecting both companies’ visions for a safer, more efficient future. The integration of Amprius’ SA10 cells into KULR’s battery packs is poised to revolutionize the landscape of power sources for the defense and aerospace sectors, offering unprecedented reliability and safety.
About Amprius Technologies, Inc.Amprius Technologies, Inc. is a leading manufacturer of high-energy and high-power lithium-ion batteries producing the industry’s highest known energy density cells. The company’s commercially available SiMaxx™ batteries deliver up to 450 Wh/kg and 1,150 Wh/L, with third party validation of 500Wh/kg and 1,300 Wh/L. The company’s corporate headquarters is in Fremont, California, where it maintains an R&D lab and a MWh scale manufacturing facility for the fabrication of silicon anodes and cells. To serve customer demand, Amprius entered into a lease agreement for an approximately 774,000 square foot facility in Brighton, Colorado, and expanded its product portfolio to include the SiCore™ platform. For additional information, please visit amprius.com. Also, see the company’s LinkedIn and X pages.
Mr. Mo is a technology entrepreneur and successful investor with over 20 years of experience in technology management, product development, and marketing. From 2007 to 2015, Mr. Mo served as Senior Director of Business Development at Amlogic, Inc. Prior to Amlogic, he was co-founder and CEO of Sympeer Technology, a peer-to-peer network company. Mr. Mo received a Master’s degree in Electrical Engineering from UC Santa Barbara in 1995.
KEITH COCHRAN
PRESIDENT & COO
Mr. Cochran is a value-driven leader offering 25+ years of exceptional high-paced business management and operations expertise. From 1995 to 2019, he worked for world-class EMS, Jabil, Inc. He concluded his 24-year career with Jabil as Sr. Vice President of Global Business Units. Prior to Jabil, Mr. Cochran was Supply Chain Manager for SCI Systems. Mr. Cochran received his Bachelor of Science in Business Operations from DeVry Institute of Technology in 1990.
Dr. Walker has significant experience in professional and research-related activities focused on thermo-electrochemical testing and analysis of lithium-ion (Li-ion) battery assemblies and related thermal management products designed for space exploration applications. Prior to joining KULR, Dr. Walker was employed by the National Aeronautics and Space Administration (NASA) Johnson Space Center (JSC) where he focused on designing battery assemblies for human spaceflight applications capable of safely mitigating the effects of thermal runaway and preventing cell-to-cell propagation. Dr. Walker received his B.S. in Mechanical Engineering at West Texas A&M University (WTAMU) and Ph.D. in Materials Science and Engineering at the University of Houston (UH).
SIMON WESTBROOK
CHIEF FINANCIAL OFFICER
In 2009, Mr. Westbrook founded Aargo, Inc., a company specializing in financial consulting services to corporations in various tech-related industries. Prior to Aargo, Mr. Westbrook was CFO of Amber Networks, Inc., and the Chief Financial Officer of Sage, Inc. (NASDAQ: SAGI), a Silicon Valley company specializing in flat panel displays. Before Sage, Mr. Westbrook held senior level financial positions at Creative Technology (NASDAQ: CREAF) and Atari Corp (AMEX: ATC). Simon is a Chartered Accountant and holds a Master’s degree in Economics from Trinity College, Cambridge University.
MICHAEL G. CARPENTER
VICE PRESIDENT OF ENGINEERING
Mr. Carpenter was former Director and Safety Officer of Energy Science Laboratories PCM Heatsink Group. He also served as Quality Manager and Facility Security Officer in the Defense Industrial Security Program from 1988 to 1995. Mr. Carpenter received a B.S. in Applied Mechanics from UC San Diego in 1983.
TED KRUPP
VICE PRESIDENT OF SALES AND MARKETING
Mr. Krupp joins KULR with over 22 years of supplying MIL-SPEC computing solutions to U.S. military and intelligence system integrators. Prior to joining KULR, Mr. Krupp served as Vice President of Sales at San Diego based ZMicro, the preferred choice for rugged computing and visualization for deployed and mission critical applications. He expanded ZMicro’s involvement in several platforms, including special operations, ground vehicle systems, tactical datalinks, and next-generation ISR and eventually led ZMicro’s sales department as the company continued to grow in prominence across the Department of Defense and foreign military community. Mr. Krupp completed his undergraduate work in Information Systems at the University of Texas.
ANTONIO MARTINEZ
VICE PRESIDENT OF OPERATIONS
Mr. Martinez joins KULR with over 37 years of leadership and worldwide manufacturing experience in Electronics Manufacturing and Operations. He spent most of his career at Pulse Electronics Corporation in the electronics manufacturing services industry. Most recently he served as Principal Program Manager of Jabil since 2015, managing business operations spanning Quality Assurance Readiness, Large Production Line Transfers, Project Management, Process Improvement with Increased Productivity, and Customer Qualification Support.
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Cash, cash equivalents and short-term investments totaled $121.3 million as of March 31, 2024
ATAI offers a diverse pipeline of drugs and a focus on compounds with prior evidence in humans, upcoming inflection points (multiple Phase 1 and Phase 2 proof-of-concept trial readouts are expected in the next two years)
With prominent backing from venture capitalists, including billionaires Peter Thiel and Christian Angermayer, atai Life Sciences ranks among the biggest biotech stocks focused on the development of mental health treatments
We have another profile for you to research for Friday’s session.
Pull up ATAI Immediately.
ATAI is a clinical-stage biotechnology company pioneering the development of novel and effective mental health therapeutics. Founded in 2018 as a response to the significant unmet need and lack of innovation in neuropsychiatry, atai is dedicated to developing compounds with prior evidence in humans, particularly those that have been overlooked and not rigorously studied, such as psychedelics.
ATAI is developing medicines to treat large and underserved patient populations, including those living with cognitive decline associated with schizophrenia, anxiety, depression and substance use disorders.
ATAI’s cash position is among the strongest in the psychedelic medicine space, with approximately $273M (as of December 31, 2022) and access to up to an additional $160M via term loan facility providing an anticipated runway into H1 2026.
After watching loved ones struggle with mental health issues, Brand realized that patients across the world were not getting the treatments they needed.
With prominent backing from venture capitalists, including billionaires Peter Thiel and Christian Angermayer, atai Life Sciences ranks among the biggest biotech stocks focused on the development of mental health treatments.
atai Life Sciences takes a holistic approach to “treat the patient, not the condition.” A leader in the mental health space, the company comes with experience and history of psychedelics, and is equipped to deliver the next generation of mental health medicines.
MAJOR CATALYSTS
Large Market Potential: Mental health disorders are one of the largest global health burdens; global market size in mental health was $380Bn in 2020 and is expected to grow to $509bn by 2028.
Clear Objective: atai’s objective is to achieve clinically meaningful and sustained behavioral change in mental health patients by developing rapid-acting and patient-centric pharmaceutical and digital treatment solutions.
Large Unmet Clinical Indications: atai’s clinical pipeline is currently in development to treat large and underserved patient populations, including those living with cognitive decline associated with schizophrenia, treatment-resistant depression, anxiety, and substance use disorders.
Multiple Shots on Goal: atai has 8 clinical stage drug development programs with a focus on compound classes with prior evidence in humans. Its diversified platform approach helps avoid binary risk and optimizes likelihood of success.
Significant Catalyst Event Potential: Company expects to deliver multiple R&D milestones anticipated across key clinical programs over next 2 years.
Strong Cash Position: Cash, cash equivalents and short-term investments totaled $121.3 million as of March 31, 2024.
Strong Market Validation: Validation of atai’s operating model and ability to capture value: IPO of COMPASS Pathways in 2020 and licensing deal between Otsuka and atai subsidiary Perception Neuroscience in 2021.
Compassionate Vision: To heal mental health disorders so that everyone everywhere can live a more fulfilled life.
ATAI tackles the mental health crisis with a unique de-risking approach focused on a diverse pipeline of compounds with prior evidence in humans
By pooling resources and best practices, atai aims to responsibly accelerate the development of new medicines to achieve clinically meaningful and sustained behavioral change in mental health patients.
Key Strategic Pillars
Rapid acting intervention: 1st, 2nd and 3rd generation compounds with the potential to show strong behavioral plasticity, rapid onset and more durable effects
Ongoing psychological support: Digital therapeutics deliver care to patients before, during and/or after initial treatment intervention
Precision mental health: The identification of patient sub-types using biological and digital biomarkers
You can read more about the company’s programs HERE.
atai’s diverse clinical pipeline gives multiple shots on goal with numerous upcoming R&D milestones
ATAI’s pipeline includes 8 clinical stage drug development programs with a focus on compound classes with prior evidence in humans; this approach involves a pharmacologically diverse pipeline to avoid binary risk while optimizing likelihood of success.
The Potential of Psychedelics
Psilocybin (a hallucinogenic compound) and DMT (a powerful and rapid acting psychedelic present in ayahuasca) have been highly buzzed about in the mental health arena for their potential as a long-lasting, highly effective treatment.
ATAI Life Sciences is embarking on the study of these and other drugs for their potential to effectively and rapidly treat many mental health disorders that are resistant to treatment.
ATAI is a leader in the mental health pharmaceutical market as the company works to deliver on its clinical strategies with immense market potential.
Today, the global mental health market size has reached US$ 380 Billion. Looking forward, IMARC Group expects the market to reach $509 Billion by 2028, exhibiting a growth rate (CAGR) of 3.4% between 2023-2028.
The growing, underserved mental health space leads us to atai Life Sciences. The company has an innovative approach to solve the real and growing problem of mental health disorders with a unique digital approach.
Addressing Depression, Anxiety, Addiction, and other Mental Health Disorders with a compassionate mission. atai is zooming in on robust categories in the mental health treatment market.
Schizophrenia
Problem: Cognitive impairment is a core feature of schizophrenia for the 24m people who live with it. 98% of patients with schizophrenia perform worse on cognitive tests than expected. There are no FDA approved therapies for Cognitive Impairment Associated with Schizophrenia (CIAS).
Atai’s answer: atai is investigating RL-007, a novel compound that has shown pro-cognitive effects in numerous Phase 1 and 2 studies.
Anxiety
Problem: Anxiety disorders are the most comment mental health concern in the United States and not only do less than half of those affected receive treatment, but currently approved medications come with significant side effects and/or risk of dependence.
Atai’s answer: atai is investigating deuterated etifoxine, a patent protected version of etifoxine, a drug approved for anxiety in more than 40 countries with benzodiazepine-like effects but without the sedative effects and addictive potential.
Depression
Problem: Depression affects more than 300m people and is the 2nd leading cause of disability worldwide. Only about 1/3 of patients respond to existing treatments and standard-of-care drugs like SSRIs come with significant side effects ranging from weight gain to suicidality.
Atai’s answer 1: COMP360 (patented protected synthetic psilocybin) is in late-stage studies for treatment-resistant depression.
Atai’s answer 2: atai is studying VLS-01 (oral thin film DMT) for treatment-resistant depression.
Substance Use Disorder
Problem: Over 20m people live with a substance use disorder (SUD) in the US. Since the drug epidemic started in 1999, there have been over 900,000 overdose fatalities. For an already vulnerable population, COVID-19 severely exacerbated the crisis for those with a SUD. Drug overdose deaths shot up ~30% with close to 93,000 deaths in 2020, nearly 70,000 of which involved opioids. With only 2 FDA approved treatments for OUD, options are limited, and relapse rates are as high as 75%.
Atai’s answer: atai is studying DMX-1002, an oral formulation of ibogaine, a naturally occurring psychedelic compound isolated from a West African shrub. In uncontrolled studies, Ibogaine has demonstrated rapid and sustained efficacy for OUD.
atai Life Sciences Investment Thesis: A Uniquely Positioned Leader In Mental Health Drug Development with Compelling De-risked Approach and Trading Below Cash
Atai has a market cap of ~$207M as of March 17, 2023 despite cash balance of $304m as of September 30, 2022, an aprox. $80M stake in COMPASS Pathways as of March 17, 2023 and multiple clinical stage drug candidates in development that tackle the mental health crisis
atai Life Sciences Reports First Quarter 2024 Financial Results and Corporate Updates
PUBLISHED
MAY 15, 2024 6:59AM EDT
First participant dosed in Phase 1b trial of VLS-01 with data expected in 2H’24; Phase 2 study in TRD patients anticipated to initiate around YE’24
Beckley Psytech’s Phase 2a study of BPL-003 in TRD patients showed rapid and durable antidepressant effects; Phase 2b topline data expected in 2H’24
Compass Pathways’ Phase 2 study of COMP360 in PTSD patients demonstrated durable improvement in symptoms; Phase 3 data of COMP360 in TRD patients expected in 4Q’24
Co-Founder Florian Brand to step down as CEO as part of a planned transition by YE’24 and to be succeeded by Co-Founder and current Chief Scientific Officer Srinivas Rao, M.D., Ph.D.
Cash, marketable securities, and committed term loan funding expected to fund operations into 2026
NEW YORK and BERLIN, May 15, 2024 (GLOBE NEWSWIRE) — atai Life Sciences (NASDAQ: ATAI) (“atai” or “Company”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today announced first quarter 2024 financial results, provided corporate updates and announced a transition in its leadership.Florian Brand (“Mr. Brand”), Co-Founder and current CEO, will step down as CEO by the end of this year. Co-Founder Srinivas Rao, M.D., Ph.D. (“Dr. Rao”), currently the Chief Scientific Officer, will be promoted to Co-CEO effective June 1, 2024 and intends to assume the role of CEO by the end of the year subject to appointment as required by local law.“I co-founded atai in 2018 with the bold mission to transform mental health care, and I am immensely proud of our accomplishments and continuous progress made across our R&D programs over the last six years. To that end, looking at the recent months, we have achieved many clinical milestones, with dosing in our VLS-01 Phase 1b program well underway and encouraging Phase 2 data readouts from both BPL-003 and COMP360,” said Mr. Brand.“As I prepare to turn my focus to new entrepreneurial ventures in other areas of significant unmet medical needs, I am confident in passing the torch to my Co-Founder Srini by year-end. His exceptional leadership and deep expertise in neuropsychiatric drug development have been pivotal to our success, and I am delighted that he will be leading atai into its next phase, where his experience in late stage clinical development will be especially relevant and impactful.”Dr. Rao brings over 24 years of knowledge and experience from diverse biotechnology and pharmaceutical roles, having held the titles of Chief Scientific, Medical, or Executive Officer at companies ranging from venture-backed startups to vertically integrated, publicly traded pharmaceutical companies.“It is an honor to follow in the footsteps of my dear friend and Co-Founder, Florian. I am deeply grateful for the opportunity to continue to work with him as Co-CEOs until the end of the year and build upon our shared vision, ensuring atai’s continued success in addressing challenging mental health conditions,” said Dr. Rao. “In the near-term this year, I look forward to several data milestones, including the Phase 2b readout of BPL-003 in TRD, Phase 3 data of COMP360 in TRD and the VLS-01 Phase 1b readout.”Founder and Chairman Christian Angermayer commented: “Since its inception in 2018, atai has been at the forefront of mental health innovation, driven by a commitment to deliver ground-breaking therapies to those in need, with a special focus on psychedelic substances.Florian successfully led the company from its early days through numerous R&D, business development and financing milestones, including an IPO in 2021. Florian’s leadership and execution focus have been foundational to the success of atai. We look forward to seeing the new heights he will achieve.As Florian transitions, we are deeply grateful for the enduring impact he made on our company, and while he will leave as CEO at the end of this year, he will always be part of the atai family and our success story. With his extensive experience in late stage drug development, Srini has the right profile and skillset to lead atai into its next evolutionary phase.”Corporate Updates
Florian Brand, Co-Founder and current CEO of atai, will assume the role of Co-CEO effective June 1, 2024 and will step down as CEO by the end of this year.
Co-Founder Srinivas Rao, currently the Chief Scientific Officer of atai, will be promoted to Co-CEO effective June 1, 2024, and intends to assume the role of CEO by the end of the year subject to appointment as required by local law.
Clinical HighlightsVLS-01: N,N-dimethyltryptamine (DMT) for Treatment-Resistant Depression (TRD)
VLS-01 is an oral transmucosal film (OTF) formulation of DMT designed to fit within the two-hour in-clinic treatment paradigm successfully established by Spravato®
In March 2024, we announced the initiation of dosing in a Phase 1b study that is designed to evaluate the relative safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of an optimized OTF formulation of VLS-01, compared to intravenous (IV) DMT.
Results of the Phase 1b study are anticipated in 2H 2024.
The Company plans to initiate a randomized, placebo-controlled Phase 2 trial of VLS-01 in TRD patients around YE’24.
BPL-003: 5-MeO-DMT for TRD as primary indication
Beckley Psytech’s BPL-003 is an intranasal formulation of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) designed to fit within an approximately two hour in-clinic treatment paradigm.
In March 2024, Part 1 of a Phase 2a open-label (OL) study showed that a single administration of BPL-003 resulted in rapid and durable antidepressant effects, with 45% of patients in remission three months after dosing. Acute effects resolved on average in less than two hours, and BPL-003 was found to be well-tolerated, with no serious adverse events reported.
In April 2024, Part 2 of the Phase 2a OL study initiated to investigate BPL-003 as an adjunctive therapy to Selective Serotonin Reuptake Inhibitors in TRD patients.
A randomized, controlled Phase 2b study of BPL-003 in TRD patients is underway with topline data expected in 2H 2024.
COMP360: Psilocybin Therapy for TRD as primary indication
Compass Pathways’ COMP360 is an oral formulation of synthetic psilocybin that is currently being evaluated in multiple clinical studies.
In May 2024, results from an OL Phase 2 study in 22 patients with PTSD showed that COMP360 met its primary safety endpoint and was well tolerated, with no serious adverse events. COMP360 demonstrated a rapid and durable improvement in PTSD symptoms.
Week 4 and 12 reductions in the CAPS-5 total score of 29.9 and 29.5, respectively, were observed.
The response rate, as defined by patients experiencing a ≥ 15-point improvement on CAPS-5 score, was 81.8% at week 4 and 77.3% at week 12.
The remission rate, as defined by CAPS-5 total score of ≤ 20, was 63.6% at week 4 and 54.5% at week 12.
The Phase 3 program of COMP360 in TRD patients is composed of two pivotal trials, each with a long-term follow-up component. Pivotal Trial 1 (COMP005) topline data is expected in the fourth quarter of 2024 and Pivotal Trial 2 (COMP006) topline data is anticipated mid-2025.
Upcoming R&D Catalysts
1H’24
ELE-101 MDD Phase 1/2a initial data
2H’24
VLS-01 Phase 1b topline data
BPL-003 AUD Phase 2a OL data (mid’24)
COMP360 TRD Phase 3 Pivotal Trial 1 topline data
BPL-003 TRD Phase 2b data
IBX-210 OUD Phase 1/2a initiation
VLS-01 TRD Phase 2 initiation (around YE’24)
2025
RL-007 CIAS Phase 2b topline data (mid’25)
COMP360 TRD Phase 3 Pivotal Trial 2 topline data (mid’25)
Consolidated Financial ResultsCash, cash equivalents, and short-term investments: As of March 31, 2024, the Company had cash, cash equivalents, restricted cash and short-term investments of $121.3 million compared to $154.2 million as of December 31, 2023. The decrease of $32.9 million was primarily driven by $22.6 million net cash used in operating activities and $10 million for the Beckley Psytech investment. The Company expects its cash, marketable securities and committed term loan facility with Hercules Capital, Inc. to be sufficient to fund operations into 2026.Research and development (R&D) expenses: R&D expenses were $11.5 million for the three months ended March 31, 2024, as compared to $19.3 million for the same prior year period. The year-over-year decrease of $7.8 million was primarily attributable to a decrease of $5.1 million in program-specific expenses and $2.6 million in R&D personnel. Within program-specific expenses, the decrease was primarily driven by more clinical trials, discovery expenses and manufacturing costs in prior year. During the quarter, the Company allocated capital resources to invest in the R&D activities of its Beckley Psytech strategic investment. The Company is anticipating R&D spend to increase as its R&D programs progress into later stage clinical trials.General and administrative (G&A) expenses: G&A expenses for the three months ended March 31, 2024 were $12.6 million as compared to $14.0 million in the same prior year period. The year-over-year decrease of $1.4 million was primarily attributable to $2.6 million decrease in personnel related expenses, $0.7 million net decrease of professional services and other administrative expenses, partially offset by a $1.9 million increase related to a prior year non-income tax refund. The Company is actively controlling G&A spend. The Company expects the reduction in G&A spend over prior years to continue.Net loss: Net loss attributable to stockholders for the three months ended March 31, 2024, was $26.7 million as compared to $33.1 million for the three months ended March 31, 2023.
Florian Brand is the co-founder and Chief Executive Officer of atai Life Sciences. Prior to joining atai, Florian was starting and building user-centric technology companies as a serial entrepreneur.
Florian suffered from anxiety in his youth and was able to achieve remission through a combination of psychotherapy and robust meditation practice. It was ultimately his experiences seeing his friends and loved ones failed by the mental healthcare system that inspired him to join the movement to transform the treatment landscape for patients who have been unable to find relief in currently available therapies.
In 2022, Florian was recognized in Fortune’s 40 Under 40 list spotlighting influential individuals shaping business and Business Insider’s 30 Under 40 in Healthcare. Florian was also featured in Endpoint News’ list of 20 Under 40 Innovators in Biotech in 2021. He is a proud member of the Founders Pledge, a global community of mission-aligned entrepreneurs dedicated to doing good.
“We know that mental healthcare is likely the single largest unmet medical need in the world. We know that what’s out there now isn’t working. And we know that there are better options. So, let’s bridge the gap together.”
Srinivas Rao M.D., Ph.D.
Srinivas Rao is the Chief Scientific Officer at atai Life Sciences. Dr. Rao has over 19 years of professional experience in the pharmaceutical and biotechnology industries. Prior to atai, Dr. Rao has held the titles of Chief Scientific, Medical, or Executive Officer at companies ranging from venture-backed startups to vertically-integrated, publicly-traded pharmaceutical companies.
Dr. Rao completed an internship in Internal Medicine at Yale-New Haven Hospital. He received his Ph.D. in neurobiology from Yale Graduate School and his M.D. from Yale School of Medicine. He holds both a Bachelor of Science and Master of Science degree in Electrical Engineering from Yale College and Yale Graduate School, respectively.
Rolando Gutiérrez-Esteinou, M.D.
Rolando Gutiérrez-Esteinou is the Chief Medical Officer at atai Life Sciences since 1 January 2021. Dr. Gutiérrez-Esteinou has over 25 years of professional experience in the pharmaceutical and biotechnology industries. Prior to atai, Dr. Gutiérrez-Esteinou has held various titles of Chief Medical Officer, SVP or VP in Clinical Development, Project Management, Medical Affairs, and Pharmacovigilance at Novartis, J&J and BMS, and small biotech companies, as well as serving as therapeutic area head in Neuroscience at Covance, a large clinical research organization.
Dr. Gutiérrez-Esteinou is a graduate of the National Autonomous University of Mexico School of Medicine, in Mexico City, and completed a medicine internship and a residency in Adult Psychiatry at Harvard Medical School. He was the recipient of a Fogerty International Fellowship at the National Institute of Mental Health in the Experimental Therapeutics Branch.
Stephen Bardin
Stephen Bardin joined atai Life Sciences in 2022.
Previously, Stephen was Senior Vice President, Finance and Operations at BridgeBio Pharma, Inc. where he was responsible for a broad range of finance topics, including financing strategy and execution, M&A transactions, FP&A, financial operations, and IT.
Prior to that, he worked in finance and corporate development at Myovant Sciences where he was responsible for the evaluation of business development opportunities, financing transactions, investor relations, financial operations, and special projects.
Stephen holds a Bachelor’s degree in Biomedical Engineering from Duke University and an MBA from the Stanford Graduate School of Business.
Sahil Kirpekar, M.D.
Dr. Kirpekar joined atai in 2022 after more than eight years at Otsuka Pharmaceutical Co., Ltd., most recently as the Head of Business Development and Co-chair of the Global Business Development Committee.
During his tenure, Dr. Kirpekar helped build a successful pipeline of assets in CNS and beyond and was responsible for closing transactions with a total value of more than USD 2.7 billion. Notable accomplishments during his time at Otsuka also include the successful commercial launch of two drugs, Abilify Maintena (Aripiprazole) and Jinarc (Tolvaptan), and contributing to the organization’s digital strategy and leading their evolving thinking in precision psychiatry. He also collaborated closely with atai on certain strategic investments during this time.
Prior to Otsuka, Dr. Kirpekar built and executed commercial and market access strategies for biopharmaceutical companies globally as a strategy consultant at Double Helix Consulting (McCann Consulting). He also served as a market analyst for the World Health Organization and has co-founded a company building a drug delivery device focused on adherence. Dr. Kirpekar is a trained physician and holds an MPhil from the University of Cambridge (where he is subsequently an honorary lecturer).
Anne Johnson
Anne Johnson joined atai Life Sciences in 2021 as Vice President, Global Controller.
Previously, Anne was a Controller at Aruvant, an International Biotechnology Company, focusing on gene therapies for rare diseases. Prior to this, she has held a number of senior leadership roles within the CFO office, include Corporate Controller at Chimerix, Inc and VP Finance at Xanodyne Pharmaceuticals.
She holds a B.Sc in Accounting from the University of North Carolina at Wilmington and is an AICPA qualified accountant.
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Greenwave Technology Solutions Generates More than $9 Million Revenue in Q4 2023
GWAV Achieved over $30M in revenues last year and is on track to generate record revenues this year
GWAV operates 13 metal recycling facilities in Virginia, North Carolina, and Cleveland, OH
Company has improved its balance sheet by $27 million over the past 90 days
Greenwave believes it is on track to generate record revenues with record volume of steel processed in 2024
Greenwave CEO Exchanges $7.22 Million in Debt into Common Shares at $0.1167/Share – Additionally, Company CEO Exchanges $10 Million in Debt into Shares of Series D Preferred
_________________________
Hello Everyone,
We have past winner for you to research again for tomorrow’s session.
Pull up GWAV Immediately.
This one just completed a 1 for 150 reverse stock split, drastically reducing the float down to a minuscule amount for the time being.
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.
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 last year saw Greenwave Technology Solutions, Inc. (Nasdaq: GWAV) achieve 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.
Greenwave’s Scrap App
Greenwave recently announced that its wholly-owned subsidiary, Scrap App, launched new AI-powered features to optimize pricing and sales. In a recent press release, Greenwave stated that the company anticipates Scrap App’s planned national expansion, coupled with its AI strategy, will accelerate growth.
Greenwave Chairman and CEO Danny Meeks stated “We plan to expand Scrap App to multiple new markets across the United States in the coming weeks. As a technology platform, Scrap App has the ability to scale to new markets with minimal capital investment – we do not have to open a new facility, purchase additional equipment, or significantly expand overhead when we enter a new city. We believe Scrap App has the potential to generate significant, high-margin revenue and create value for Greenwave shareholders.”
Greenwave Eliminates All Convertible Debt
PUBLISHED
MAY 22, 2024 6:00PM EDT
Final Conversion of $18 Million in Convertible Debt Occurred Today
Greenwave Eliminated an Additional $17.2 Million in Debt Held by Chairman
Company Now Has No Convertible Debt or Preferred Shares Outstanding
Greenwave Bolsters Balance Sheet with $21.8 Million in Cash
CHESAPEAKE, Va., May 22, 2024 /PRNewswire/ — Greenwave Technology Solutions, Inc.(“Greenwave” or the “Company”) (Nasdaq: GWAV), an operator of metal recycling facilities in Virginia, North Carolina, and Ohio, today announced that it has retired all of its convertible debt and preferred shares. Since the beginning of 2024, Greenwave has eliminated $35.2 million in debt, including $17.2 million of debt held by the Company’s Chairman and CEO.
With a significantly strengthened balance sheet, the Company intends to expand its operations in the coming weeks. Greenwave expects to generate approximately $40 million in revenue in 2024, driven by processing volumes of steel and copper.
Greenwave Technology Solutions’ Exchanges All Outstanding Notes Held by its Chief Executive Officer into Equity
Greenwave CEO Exchanges $7.22 Million in Debt into Common Shares at $0.1167/Share
Additionally, Company CEO Exchanges $10 Million in Debt into Shares of Series D Preferred
CHESAPEAKE, Va., May 7, 2024 /PRNewswire/ — Greenwave Technology Solutions, Inc. (“Greenwave” or the “Company”) (Nasdaq: GWAV), a leading operator of metal recycling facilities in Virginia, North Carolina, and Ohio, is pleased to report its Chairman and Chief Executive Officer, has exchanged an aggregate of approximately $17.22 million in debt into equity comprised of (i) $10.00 million in debt exchanged for shares of Series D Preferred Stock and (ii) $7.22 million in debt exchanged into common stock at $0.1167 per share.
“Over the past several weeks, we have significantly strengthened Greenwave’s balance sheet and positioned the Company for the next phase of its growth,” stated Greenwave CEO Danny Meeks. “I believe exchanging my debt into equity further aligns me with all shareholders and reflects the confidence I have in our business and growth strategy.”
Greenwave Technology Solutions Further Strengthens its Balance Sheet
APR 23, 2024 7:07AM EDT
Company has improved its balance sheet by $27 million over the past 90 days
Chairman and CEO has converted all $17.22 million of his debt into equity
Company bolsters balance sheet with $5.25 million capital infusion
CHESAPEAKE, Va., April 23, 2024 /PRNewswire/ — Greenwave Technology Solutions, Inc. (“Greenwave” or the “Company”) (Nasdaq: GWAV), a leading operator of metal recycling facilities in Virginia, North Carolina, and Ohio, announced today that on April 22, 2024, it further strengthened its balance sheet by approximately $12 million.
Greenwave Recent Highlights:
Improved balance sheet by approximately $27 million over the past 90 days
Chairman and CEO exchanged approximately $17 million of debt into equity
Intends to utilize additional cash flow to aggressively grow operations
Anticipates starting operations for its second shredder in May
Plans to expand its wholly-owned technology platform, ScrapApp.com, into new markets and continue AI development
Plans to enhance margins of its Downstream Processing System with implementation of new Copper Extraction Technology
Expects to regain full compliance with all Nasdaq listing standards by the end of May
Seeks to accelerate efforts in social media, digital marketing and data analytics
On track to generate record revenues with record volume of steel processed in 2024
Greenwave Technology Solutions Strengthens Balance Sheet by Approximately $14.87 Million
PUBLISHED
APR 1, 2024 9:55AM EDT
Company Believes it Has Regained Compliance with Nasdaq’s Shareholder Equity Requirement
CHESAPEAKE, Va., April 1, 2024 /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 during the first quarter of 2024, it received proceeds from warrant exercises of approximately $2.81 million, converted approximately $2.06 million of third party debt to equity, and exchanged $10 million of related-party debt into equity. As a result of the foregoing, the Company has increased its shareholder’s equity by approximately $14.87 million.
The Company believes it has regained compliance with the minimum $2.5 million stockholders’ equity requirement and satisfies the minimum $5 million equity requirement for initial listing on The Nasdaq Capital Market.
Further, the Company has secured waivers from its senior secured note holders of the quarterly-cash covenants until September 30, 2024, as well as monthly amortization payments until July 31, 2024. The Company expects to utilize the additional cashflows from restructuring its debt to grow its operations.
Greenwave believes it is on track to generate record revenues with record volume of steel processed in 2024. For more information, please see the Company’s Current Report on Form 8-K filed with the U.S. Securities and Exchange Commission on April 1, 2024.
Greenwave Technology Solutions’ Second Shredder Currently Being Connected to Power Grid by Dominion Energy Ahead of Schedule
PUBLISHED
MAR 25, 2024 8:34AM EDT
The second shredder is expected to boost annual revenues by approximately $4.8 million, with significant increase to gross profit
Second shredder on track to be connected to power grid by March 29, 2024 and commence operations shortly thereafter, doubling Greenwave’s annual shredded ferrous output
Greenwave is now one of the largest independent operators of metal recycling facilities on the East Coast
CHESAPEAKE, Va., March 25, 2024 /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 Dominion Energy is currently in the process of connecting its second automotive shredder to the power grid which is expected to be completed by March 29, 2024. The Company’s second automotive shredder is expected to commence operations shortly thereafter and double Greenwave’s annual shredded ferrous output.
Greenwave’s existing automotive shredder – an American Pulverizer 60×85 – is the same make and model as its second one, providing the Company expertise in its operation and maintenance. By shredding the steel Greenwave currently sells unshredded, the Company anticipates that it will be able to generate approximately 25-30% more revenue with significant margins on that steel volume.
In October 2023, Sims Metal Management acquired Baltimore Scrap Corp., which operated 17 metal recycling facilities and four shredders, for consideration of $220 million(1). Similar to most industries, there has been a tremendous amount of consolidation in scrap metal companies during the past several years. Greenwaveis now one of the largest independent chains of scrap yards remaining on the East Coast, with significant market share in its key markets. Further, the Company believes there is significant value in its licenses, municipal and corporate contracts garnered over its 20-year operating history, robust infrastructure, and team of seasoned experts.
“Greenwave’s second shredder provides the infrastructure for us to expand our footprint of metal recycling facilities up from 13 currently – significantly growing Greenwave’s revenues, margins, and free cashflow,” stated Greenwave CEO Danny Meeks. “We believe the market is significantly undervaluing Greenwave and firmly believe that by continuing our hub-and-spoke strategy of shredder hubs with feeder yards, we will become an increasingly attractive acquisition target of the major scrap metal conglomerates.”
Greenwave is on track to grow it revenues and volume of steel processed from 2023 levels in 2024.
Greenwave’s recycling facilities collect, classify and process raw #scrap#metal, both ferrous and nonferrous, and then apply in-house technologies to increase metal processing volumes and operating efficiencies. New article from @Benzinga. Read: https://t.co/7EiJjdaa8N$GWAV
— Greenwave (Nasdaq: GWAV) (@GreenwaveGWAV) March 27, 2024
Greenwave Technology Solutions Generates More than $9 Million Revenue in Q4 2023
PUBLISHED
JAN 22, 2024 12:31PM EST
Company Grows Revenues More than 10% Over Q3 2023
Greenwave Expects to Significantly Grow Revenues in FY 2024
CHESAPEAKE, Va., Jan. 22, 2024 /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 it generated more than $9 million in revenue during the fourth quarter of 2023. The news comes on the heels of the Company commencing operations of a metal baler, wire stripper, and three sheers at its non-ferrous processing facility in Portsmouth, VA last week.
Greenwave is poised to accelerate its revenue growth in 2024, aided by the significant capital expenditures the Company has made over the past twenty-four months, some of which include additional processing equipment, a fleet of trucks to more efficiently transport materials for processing and sale, and technologies aimed at growing top line sales as well as creating operating efficiencies to enhance margins.
With more than 20 years of experience in the metal recycling industry, Empire’s leadership has grown the Company through nearly every economic climate and is committed to creating long-term shareholder value.
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.
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