Vocodia Announces Phase One of Service Platform Installation at Dealers of One of Big 3 Automobile Reseller
VHAI is expecting to add its AI-empowered platform into an expected 1800 dealerships, with 1000 of them implemented by Q2/2024
Meet the Groundbreaking Conversational AI that Qualifies Leads Like a Machine
Brian Podolak, Co-Founder, Chief Executive Officer and Director of Vocodia, invested $400,000 through the purchase of 94,117 units of the IPO AT THE OFFERING PRICE!
🌟 Thrilled to be featured in #USATODAY for our groundbreaking work at Vocodia! 🌟
We are back with another brand new profile that we have never featured on our newsletter before. That is probably because this one is brand new to the market after just completing a $5.9Mill IPO in the hottest sector on earth right now.
Everyone wants a piece of AI.
Companies like NVIDIA, Advanced Micro Devices & Palantir are dominating the majority of sector headlines. What is important to note is that those companies serve a tiny fraction of the broader AI market opportunities, meaning specialized players like our new profile can certainly can be significant contributors.
Pull up VHAI immediately.
The CEO likes this one so much he invested $400k of his own cash in the IPO at the same price everyone else got.
How about putting your money where your mouth is?
Im sure he is in it for the long haul and nobody is going to know the potential of the company and its holdings better than the CEO Mr. Podolak.
On top of that James Sposato, Co-Founder, Chief Technology Officer and Director, and Scott Silverman, Chief Financial Officer, also participated in the IPO. All units were purchased at the offering price of $4.25.
I guess management is bullish on this one long term.
VHAI is an AI software company that build practical AI functions and makes them easily obtainable for businesses on cloud-based platform solutions at low costs and scalable to multiagent vast enterprise solutions. Vocodia is a conversational AI software developer and provider that offers scalable enterprise-level AI sales and customer service solutions which allow for AI sales representatives to reduce human labor costs and responsibilities while increasing the reach and efficacy of human-led, purposeful, agenda driven and conversational communications. Vocodia deliver its patent pending conversational AI software in the form of Digital Intelligent Sales Agents (the “DISAs”), which are built with AI software programmed to sound and feel human and to perform business tasks that require humans to converse with one another effectively, and thus to provide the best representation for each of its customers’ businesses.
VHAI’s comprehensive AI portfolio is more than a huge advantage for its clients; it highlights a value proposition for investors wanting exposure to the booming AI sector. The bullish case for Vocodia Holdings isn’t just warranted; it’s compellingly justified. In fact, after a post-IPO pullback, the disconnect between the company’s intrinsic potential and current share price may be best described as an opportunity too good to ignore.
The global market for AI continues to experience rapid growth, growing from a projected $433BB (US) in 2022 to over half a trillion dollars in 2023. Although projections vary, the global AI market is expected to grow exponentially to nearly $1.6 trillion by the end of the decade.
The market for AI technologies comprises three primary segments–software, hardware, and services. While the software segment is by far the largest, Vocodia’s placement in both the software and service segments highlights the unique breadth of the Company’s potential.
Having attained a remarkable degree of success since its initial product release, Vocodia is positioned to grow through continued platform innovation and expanded marketing efforts.
This year the Company is launching into the next phase by broadening its offerings to include professional services, DISA 2.0, and database integration, in order to expand its sales and service channels.
Competitive Advantages
Vocodia has created software that is intended to replicate the functions of human sales representatives, such as calling prospects by telephone, announcing the purpose of a call and reason for the call, and identifying interest in a conversational manner. The AI/platform can be programmed for each client to provide scalable solutions which can reduce sales inefficiencies and improve customer service results. They commoditize and standardize their AI solution to improve traditional sales and customer service support operations in order to meet their clients’ sales and service goals.
Additional Opportunities
Vocodia plans on pursuing opportunities beyond their present goals of delivering sales and customer service software agents. Vocodia believes there may be other uses of their conversational AI software and platform, such as in the areas of education, including the areas of philosophy, and religion. In the long run, they envision a world in which businesses and consumers have conversational AIs, such as their DISAs, performing the tasks of humans-all the while-maximizing efficiencies in many fields and improving timing, quality, budget, and convenience, using automated tools. In short, Vocodia aims to make the world a better place by using their proprietary AI to improve current processes.
Technology
Vocodia believes that hawse have built, and will continue to build, AI conversational systems that sound virtually the same as humans. Proprietary software and systems have been developed in-house from scratch with streamlined integration and a growing number of CRMs and platforms all over the world. Vocodia’s software use Artificial Intelligence, Augmented Intelligence, Natural Language Processing and Machine Learning to provide a robust, continuously learning engine which can perform multiagent functions simultaneously. Vocodia’s software is cloud-based, permitting easy API integration with most systems and platforms commonly used by businesses today.
Products
Vocodia has developed and released its first software product and platform, which they refer to as “DISA” which is a humanized conversational AI technology DISA sales agent that can complete each stage of the conversational aspect of the sales process, business-to-business (“B2B”) and business-to-consumer (“B2C”).
Vocodia’s prospects for direct software sales are any enterprise clients who are in the phone and call center markets. The initial sales targets were call centers who needed to replace poor performing staff in the pre-Covid-19 era. Now, their sales targets have shifted to filling empty seats in the call centers. Their technology consists of a virtual agent, the DISA. In the current marketplace, they consider any corporate client with a 50-seat call center at a telephony location a potential sales client. These potential clients span many industry verticals, including but not limited to, health, solar, employee retention credit, insurance, recruiting and real estate, automotive, cruise lines and hospitality and lodging. Vocodia’s AI sales agents not only sell and serve prospects and customers, but also gather and report robust intelligence from customers and the marketplace. Vocodia’s DISAs are programmed to instantly answer customer service calls and to upsell and provide personalized customer care.
Vocodia integrates a sales force that never tires, never falters, and never misses a beat. That trio is the ultimate accelerator for businesses hungry for success. For many, it could serve as rocket fuel to enhance competitive position and expedite target market domination. That may sound like embellishment, but it isn’t: DISA is justifiably being looked upon as a game-changer in AI-based communication. After all, DISA works tirelessly 24/7/365 and is designed to take advantage of every opportunity to drive sales, sign up customers, or promote the client’s brand. It also does what many people want to avoid doing themselves: cold calls. DISA eliminates that dissent by cold-calling prospects, pre-qualifying leads, and even sending out reminders, all with unparalleled efficiency and consistency.
The best part? It never goes off script, ensuring every interaction is on-brand and on-message. Those advantages led to a dealwith a Top 3 automobile reseller, announced Monday, with VHAI expecting to add its AI-empowered platform into an expected 1800 dealerships, with 1000 of them implemented by Q2/2024. That client see’s a simple truth- Vocodia’s ability to provide seamless integration of AI and human-like communication can be a valuable contributor to brand success by facilitating the modern business model and keeping them at the forefront of embracing technological innovation. By being able to provide best-in-industry conversational AI technology with its cutting-edge solutions, Vocodia isn’t just changing the game in conversational AI; it’s rewriting the rules.
Vocodia Announces Phase One of Service Platform Installation at Dealers of One of Big 3 Automobile Resellers
February 26, 2024
Installation at 1,800 Dealerships in Total Expected, including 1,000 in Year 1CHICAGO, Feb. 26, 2024 (GLOBE NEWSWIRE) — Vocodia Holdings Corp. (CBOE: VHAI) (“Vocodia” or the “Company”), an AI software company that builds practical AI functions, today announced that installation of its humanized AI (artificial intelligence) auto service program is expected to begin during the second quarter of 2024. Under the terms of an agreement with one of the world’s Top 3 automobile resellers, 1,800 total dealerships are expected to receive Vocodia’s AI service module; 1,000 will receive it in the first year of the agreement.
Vocodia’s AI service appointment module for auto dealerships provides 24/7 call center support for inbound inquiries including service appointment scheduling and status checking in over 50 languages. The proprietary artificial intelligence platform is highly scalable and eliminates hold time by deploying multiple Digital Intelligent Sales Agents (DISAs) to deliver a humanized conversation between machine and human that automates sales and customer service.
Brian Podolak, Founder and CEO of Vocodia, commented, “We’re excited to announce the kickoff of this program with one of the top global auto resellers. With this program, we expect revenue and profitability growth for Vocodia under its fixed price per location pricing model. With pilot programs for other auto resellers also in process, Vocodia is well positioned to deliver future growth.”
A true pioneer in the field, Vocodia’s proprietary AI boasts dedicated phone switches capable of handling 20,000 calls simultaneously, eradicating hold times and propelling the company into a new era of efficiency and customer satisfaction.
Vocodia Announces Founder and Management Team Investments in Company IPO
CHICAGO, March 26, 2024 (GLOBE NEWSWIRE) — Vocodia Holdings Corp. (CBOE: VHAI) (“Vocodia” or the “Company”), an AI software company that builds practical AI functions, today announced that the Company’s senior management team invested in Vocodia’s Initial Public Offering (“IPO”) that was completed on February 22, 2024.
Brian Podolak, Co-Founder, Chief Executive Officer and Director of Vocodia, invested $400,000 through the purchase of 94,117 units of the IPO. James Sposato, Co-Founder, Chief Technology Officer and Director, and Scott Silverman, Chief Financial Officer, also participated in the IPO. All units were purchased at the offering price of $4.25.
Mr. Podolak commented, “The team and I are proud to demonstrate our strong belief in Vocodia’s future growth by participating alongside our investors in the Company’s IPO.”
Following the IPO, Mr. Podolak and Mr. Sposato each hold approximately 1.1 million shares of Vocodia’s common stock and Mr. Silverman holds approximately 131,000 shares.
A true pioneer in the field, Vocodia’s proprietary AI boasts dedicated phone switches capable of handling 20,000 calls simultaneously, eradicating hold times and propelling the client company into a new era of efficiency and customer satisfaction.
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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
YAHOO FINANCE Has the Float at just 8.59 Million Shares Right Now
___________________________
Hello Everyone,
We have another company for you to research tomorrow ahead of tomorrow’s session. This is a company that we have never profiled on this newsletter before and has a tiny float working for it.
Pull up GWAV Immediately.
U.S. Steel Turns Down $7.3Bn Offer From Cleveland-Cliffs, Explores Alternatives – Potential Upside For Greenwave Technology Solutions, Inc. (Nasdaq: GWAV)?
Major developments in the steel industry are reshaping the landscape for key players. U.S. Steel, a significant player in the industry, has recently declined a substantial $7.3Bn acquisition offer from Cleveland-Cliffs and is now contemplating competitive proposals from Esmark Inc.
To add to the intrigue, there are rumors of ArcelorMittal SA considering entering the bid for this major steel manufacturer.
Amid this potential industry consolidation, GWAV emerges as a proactive contender, gearing up for an aggressive expansion strategy to meet the escalating demands of leading U.S. steel mills.
GWAV: Paving the Way for Growth in Metal Recycling
GWAV holds a prominent position as an operator of metal recycling facilities across Ohio, Virginia and North Carolina. Their core operations involve the collection, categorization, and processing of raw scrap metal, primarily to supply major steel mills and foundries. What sets Greenwave apart is its relentless pursuit of expansion and infrastructure enhancement, positioning itself as a key player during a potentially transformative phase in the steel industry.
Record-Breaking Growth: Positive Cash Flows and Expansion Plans
The first half of 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.
Company on track to generate record revenues in FY 2024
Second shredder will be fully operational soon and is expected to double Greenwave’s ferrous metal processing capacity
CHESAPEAKE, Va., Feb. 13, 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 released the following shareholder update:
Dear Greenwave Shareholders,
We are pleased to report that Greenwave is off to strong start in 2024 and is on track to generate record revenues this year. A few recent developments we’d like to highlight:
Both our Virginia Beach and Cleveland yards continue to post impressive growth in terms of their revenues, volumes, and profits – we expect they will soon become two of our top performing locations.
We recently commenced operations of a metal baler, wire stripper, and three sheers at our non-ferrous processing facility, enabling us to generate more revenues with higher margins on our aluminum and copper products.
Greenwave generated more than $200,000 in revenue from cars purchased through our wholly-owned subsidiary, Scrap App, Inc. (“Scrap App”), during the first 130 days since it launched, as it continues to capture market share for end-of-life motor vehicles. Scrap App is currently available in the Hampton Roads and Cleveland markets. We intend to expand Scrap App to other strategic markets in the near future.
In the coming days, we expect Virginia Dominion Power will inform of us of the final date on which our second automotive shredder will be connected to the power grid and can commence operations. Our existing automotive shredder is the same make and model – an American Pulverizer 60×85 – providing us expertise in its operation and maintenance. Given this experience, we expect our second shredder will be fully operational shortly after being connected to the power grid and is expected to double Greenwave’s ferrous metal processing capacity. By shredding the steel which we currently sell unshredded, we anticipate that we will be able to generate approximately 30% more revenue with significant margins on that steel volume.
In August 2023, Baltimore Scrap Corp. was acquired for $177 million plus working capital and other adjustments(1). While Baltimore Scrap Corp. is larger than Greenwave – it operates 17 yards, four shredders, and processes 600,000 metric tons of scrap each year – we believe this acquisition supports management’s view that Greenwave’s expansion strategy has the potential to create significant value for its shareholders.
Once our second shredder commences operations, we believe Greenwave will have the requisite infrastructure and cashflows to expand it footprint of metal recycling facilities. As a technology platform, Scrap App has the ability to scale to multiple new markets with minimal capital investment – we do not have to open a new facility, purchase additional equipment, or hire a team of people when we expand to a new market. We believe the expansion of Greenwave’s footprint and Scrap App, along with the second shredder commencing operations, will be the primary growth drivers for our revenues – and, likely, margins – in 2024.
Central to Greenwave’s growth strategy are the principles that a) we do not overpay for acquisitions and b) any deal we pursue must be properly structured to minimize dilution and limit impact to cashflow. Our goal is to utilize seller’s notes as our preferred form of consideration as we expand – we do not expect to win every deal, nor should that be our objective. We intend to spend the time and energy required to ensure the deals we pursue are fairly priced, properly structured, and have the potential to create significant value for our shareholders.
Similar to most industries, there has been a tremendous amount of consolidation in scrap metal companies over the past several years. Greenwave is now one of the largest independent chains of scrap yards remaining in the country, with significant market share in our key markets. Further, we believe there is significant value in our licenses, municipal and corporate contracts garnered over our 20 year operating history, robust infrastructure, and team of seasoned experts.
We believe the next few months will be transformative for Greenwave and look forward to sharing our progress and developments.
We thank all of our shareholders and appreciate your continued support.
To an exciting 2024,
Danny Meeks
Chairman and Chief Executive Officer
Greenwave Technology Solutions, Inc.
Greenwave Technology Solutions Generates More than $9 Million Revenue in Q4 2023 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.
Greenwave Technology Solutions’ Second Shredder Currently Being Connected to Power Grid by Dominion Energy Ahead of Schedule
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. Greenwave is 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 Technology Solutions Commences Operation of Metal Baler, Wire Stripper, and Sheers at Non-Ferrous Processing Facility
Equipment Expected to Grow Revenues by Tens of Thousands of Dollars per Month with Significant Margins
Automates Certain Manual Processes Required to Process, Transport, and Sell Aluminum and Copper Products
CHESAPEAKE, Va., Jan. 19, 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 has commenced operation of a metal baler, wire stripper, and three sheers at its non-ferrous processing facility in Portsmouth, VA.
The high capacity metal baler is capable of compacting large amounts of metal into dense bales – significantly reducing the amount of labor and cost required to process, transport, and sell copper and aluminum products. By condensing more material into each load of metal it sells, the Company will be able to reduce transportation costs and realize a greater profit margin. Further, the Company will be able to more easily export its products to domestic and international clients, potentially increasing the revenues generated by its products.
Greenwave recently completed its multi-year capex cycle, under which the Company has invested more than $15 million in its infrastructure and equipment over the past 24 months. This capex cycle is expected to double its ferrous metal processing capacity from fiscal 2022 levels and result in the Company having the infrastructure to accretively scale to over 20 metal recycling facilities.
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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Sphere 3D’s fully deployed 15,000 miners are expected to have over 1.5 Exahash and generate 940 BTC in 2024 based on current network hashrate. Gryphon earns 22.5% of gross operating profit royalty from all of Sphere 3D’s current and future blockchain operations through August 2026
During January, Gryphon mined approximately 58 bitcoin-equivalent coins and 68 BTC in December
In February GRYP Produced approximately 52 bitcoin comprised of 45 BTC from self-mining operations and 7 BTC from its bitcoin mining royalty with approximately $2.6 million in value based on an average February bitcoin price of $49,875
Certified 100% renewable energy operation heading into 2024
In a recent interview with @TheStreet, Gryphon Digital Mining CEO Rob Chang highlighted the growing institutional demand for #Bitcoin, attributing it to the coin’s intrinsic value and scarcity. Tune into the full interview here: https://t.co/GYjGo3B6sC$GRYP#BitcoinMining
— Gryphon Digital Mining (@GryphonMining) March 15, 2024
Hello Everyone,
We have another busy week planned ahead for our members.
With Bitcoin just hitting $72k and the “Halving” quickly approaching, we have been seeing crypto once again dominate the headlines.
We want you to watch this new profile that is brand new to the Nasdaq and appears to be generating millions a month in value based off of their recent news announcements.
Pull up GRYP Immediately.
Gryphon Digital Mining is a public Bitcoin miner that recently has been listed on the NASDAQ exchange and has established itself as a leader in sustainability and efficiency. Led by Rob Chang, the management team leverages its many years in the public Bitcoin miner space and utilizes an asset-light Business model to compete in this highly competitive industry.
Gryphon Digital Mining has grown significantly in the past three years by adding sustainable hashing power to its operations through strategic partnerships and ASIC fleet upgrades. The company has recently been listed on the NASDAQ exchange through a reverse merger with the public company Akerna.
Gryphon Digital attempted to execute a reverse merger in 2021 with Sphere 3D, a public net carbon-neutral cryptocurrency miner, but they both mutually agreed to not proceed with the merger. Gryphon Digital decided to enter a master services agreement to manage all of Sphere 3D’s blockchain operations for a five year period at a 22.5% gross profit royalty. Although the agreement is through August 2026, Sphere 3D has moved to terminate this arrangement. Gryphon believes that the agreement will continue on despite the litigation and forecasts over $6 million in 2024E revenue from the partnership.
Since Gryphon Digital’s stock has began trading publicly on February 9th, 2024, the stock has underperformed due to the overselling from short-term investors that were largely in the stock to capitalize on the anticipated reverse merger closing. The stock began to stabilize and the market cap is beginning to increase back to ~$100 million as the price of Bitcoin continues to climb in the current bull market. The public listing will enable Gryphon Digital to utilize the public markets to fund its M&A growth strategy and compete with bigger miners in the market.
Bitcoin mining involves specialized computers (ASICs) verifying transactions and solving complex mathematical problems to add blocks to the blockchain. Miners compete through computing power to solve these problems, with the first successful miner adding the block and receiving new bitcoins and transaction fees as a reward. The process ensures network security and decentralization, with difficulty adjusting based on how many miners are in the network to maintain a consistent block time. Bitcoin miners are all preparing for the upcoming Bitcoin supply halving which occurs every ~4 years and cuts the rewards given to miners in each block by half. This halving is expected to occur in April 2024, and miners that are operating with inefficient and obsolete fleets will not be able to survive. Historically, inefficient miners have been forced to stop operating because the cost to mine a Bitcoin doubles immediately once the halving occurs since the rewards are halved; so, miners must have a strategic plan to mitigate this. The Bitcoin mining space has already seen some consolidation in the market and many public players like Cleanspark and Marathon are shopping around for smaller companies to acquire for additional cost synergies and computing power. Gryphon Digital Mining is well-positioned to outperform less efficient public miners going into the Bitcoin halving this year and can now utilize the public capital markets for its M&A strategy and rely on its seasoned leadership team that has managed through multiple Bitcoin cycles in the past to execute sustainable growth. Additionally, the asset-light model that Gryphon Digital utilizes will enhance its flexibility and enable the company to respond to new developments in the digital asset ecosystem unlike other larger miners in the space.
Bitcoin’s code enforces a cap of 21 million coins, with 93.5% already in circulation and the remaining 1 million to be gradually distributed over the upcoming century. The mining reward halves every four years, resulting in a diminishing rate of new Bitcoin creation, making it a deflationary asset. Like in previous cycles, the price of Bitcoin has begun to see material gains in the winter period approaching the next halving; miners demand higher prices for the asset since the rewards get halved. After Bitcoin reaches the previous cycle’s all-time-high, price discovery will be unleashed again and the lucrative summer period will start.
Check out $GRYP’s February 2024 Operational Update:
☑️ Bitcoin efficiency of 57 BTC/EH ☑️ Consistently placed among the top three of publicly available #bitcoin efficiency scores
— Gryphon Digital Mining (@GryphonMining) March 11, 2024
Gryphon Digital Mining Announces February Operational Update
Self-mining hashing power reaches new all-time high
LAS VEGAS, NV / ACCESSWIRE / March 11, 2024 / Gryphon Digital Mining, Inc. (NASDAQ:GRYP) (“Gryphon” or the “Company”), a bitcoin mining company that is independently certified to be 100% carbon-neutral and pursuing a negative carbon strategy, has released its unaudited operational update for February 2024.
Key highlights for the month:
Produced approximately 52 bitcoin comprised of 45 BTC from self-mining operations and 7 BTC from its bitcoin mining royalty
Approximately $2.6 million in value based on an average February bitcoin price of $49,875
Achieved bitcoin efficiency of 57 BTC/EH[1]
Company record average self-mining hashing power of 911 PH/s
Total attributable hashing power of about ~1.3 EH/s
During February, Gryphon earned approximately 52 bitcoin coins while posting a Company record average self-mining hashing power of 911 PH/s and total attributable hashing power of approximately 1.3 EH/s. The month’s performance translated into a bitcoin efficiency rating of 57 BTC/EH.
“February was a strong month for Gryphon as we achieved all-time highs in our self-mining hashing power while earning bitcoin valued at $2.6 million based on an average BTC price of $49,875 during the month,” remarked Rob Chang, the CEO of Gryphon. “With Bitcoin prices now over $60,000 in March, we look forward to enhanced returns as we continue working on our market-leading bitcoin efficiency.”
February’s bitcoin efficiency performance of 57 BTC/EH follows January’s 67 BTC/EH performance that ranked first among publicly disclosing peers, which averaged 55 BTC/EH for the month. In the last twelve-month rolling period, Gryphon’s bitcoin efficiency ranked at or tied for first in 9 out of the 12 months, averaging 82 BTC/EH vs a peer rolling average of 68 BTC/EH. Since Gryphon commenced operations in September 2021, it has consistently placed among the top three of these publicly available bitcoin efficiency scores – ranking at or tied for first in 19 of the 29 months, or two-thirds of the time.
Gryphon’s average self-mining hashing power increased to an all time high of 911 PH/s in February. Increasing month over month by 5% as newer generation S19k Pros had a full month of operation. Total attributable hashing power remained at 1.3 EH/s. The average joules per terahash of Gryphon’s deployed fleet of miners averaged 28.9 J/T, which improved from the 29.5 J/T average observed in February 2023.
Halvening Plans
With our recent Nasdaq listing, we continue to look towards aggressively expanding through M&A opportunities and purchases of the latest generation mining equipment. With the halvening expected in April 2024, our strategy is to maintain our focus towards staying on the lower end of the mining operation cost curve, continuing to be among the most operationally efficient miners, and remaining among the most efficient[2] in deploying the capital we receive.
Conference Schedule:
Roth 36th Annual Conference held in Dana Point, CA March 17th – 19th
Empower Conference held in Houston, TX on March 26th – 27th
“The Next Frontier: Bitcoin Mining in a Post-Halving Era” Conference hosted by Maxim Groupheld virtually on April 3rd
LD Micro Invitational XIV held in New York, NY on April 8th – 9th
Bitcoin 2024 held in Nashville, TN on July 25th – 27th
Rob is an experienced executive who most recently was the CFO of Riot Blockchain and has consulted for other publicly traded blockchain mining companies. He has over 25 years of experience in the financial services industry including serving as the Managing Director and Head of Metals & Mining at Cantor Fitzgerald where he was recognized by Bloomberg as the Best Precious Metals Analyst in Q1 2016. His career achievements include rescuing a NASDAQ-listed company from bankruptcy despite regulatory and industry headwinds. Mr. Chang is frequently quoted and a regular guest of several media outlets including Bloomberg, Reuters, CNBC, and The Wall Street Journal. Mr. Chang also previously served as Director of Research and Portfolio Manager at an investment firm that managed $3 billion in assets. He currently sits on the boards of Ur-Energy and Fission Uranium. Mr. Chang completed his MBA at the University of Toronto’s Rotman School of Management.
Sim Salzman is a results-oriented Chief Accounting/Financial Officer with over 20 years of experience in public and private accounting serving clients in the cryptocurrency, hospitality, retail, food and beverage, gaming, non-profit, residential and commercial construction, real estate and low-income housing industries.
He has over two years of experience as the Chief Financial Officer and Chief Accounting Officer of one of the largest bitcoin mining Companies that grew its market cap from $500 million to approximately $8 billion within my first twelve months. There I was responsible for implementing a new accounting system, streamlining financial processes, improving efficiency and accuracy of financial reporting, forecasting, and budgeting, building a lean but high-performing financial team, and collaborating closely with senior management to align financial goals with overall business objectives while maximizing shareholder returns. Utilized the capital and debt markets to raise over $2 billion in liquidity for operational purposes.
Sim has experience as the Chief Financial Officer of a growing media and hospitality organization responsible for implementing core competencies and timely analytical reviews. Embraced multiple roles while leading a corporate restructuring that positively impacted the top and bottom line.
Five years’ experience with one of the country’s leading hospitality development and management companies as the Corporate Controller responsible for over $215M in annual revenues across 20 venues located on the Las Vegas Strip.
Sim set up policies and procedures for State and Federal compliance in regards to filing deadlines such as Unclaimed Property, Form 1042, Sales & Use Tax, Commerce and Modified Business Tax. Dealt directly with the external Tax Firm to file various annual 1065’s and liaison to the IRS for research and guidance on any pertinent issues.
Sim’s prior experience includes working for eight years in public accounting with four leading firms with clients in various industries. Passed the Uniform CPA Exam.
Chris is a leading expert in crypto data centers and has consulted North America’s largest public mining firms on building successful operations. He is a technology executive with a career spanning blockchain, cybersecurity, and enterprise software. His mix of technical and business acumen has led to successful leadership roles including acting CEO and COO of Riot Blockchain, CTO of BlueVoyant and COO and founder of Dunbar Cybersecurity. Mr. Ensey has 25 years of experience developing mission-critical software with an emphasis on large data, analytic processing, and cloud technologies. He has driven numerous products to market, including solutions for managed security services, cyber risk management, and digital healthcare. He began his career as a system engineer and integrator working on national intelligence and defense programs with SAIC. Chris has a bachelor’s degree in Computer Engineering from Virginia Tech.
BRITTANY KAISER
Chair of the Board
Brittany Kaiser is an entrepreneur, activist, and globally recognized expert in data protection and privacy. As Co-Founder of the Own Your Data Foundation, she teaches digital literacy education and training to governments, corporates, and families. She is also a Co-Founder of the Digital Asset Trade Association (DATA) for legal advocacy where she does legislative drafting and lobbying on privacy and blockchain laws. Ms. Kaiser sits on the board of many companies across industries, working on data ethics, compliance, and privacy protocols. Ms. Kaiser is also the author of Targeted published globally by Harper Collins, and she is the main subject of Netflix’s original documentary “The Great Hack”, nominated for an Emmy, BAFTA, and shortlisted for an Oscar. As a renowned thought leader and public speaker, Ms. Kaiser is represented by CAA and has spoken at prestigious events at the United Nations, the European and British Parliaments, the G20, and WebSummit, as well as guest lecturing at universities such as Harvard, Oxford, and Columbia.
STEVE GUTTERMAN
Director
Steve has built, led, acquired and invested in market-changing companies for 25 years. He is currently the CEO of Falcon International, one of the largest private cannabis companies in California.
Previously, he served as President of Harvest, since acquired by Trulieve to form the largest cannabis company in the US as measured by revenue. Prior to Harvest, he held a variety of senior roles including at E*TRADE Financial, where he was EVP and COO of E*TRADE Bank, where he was instrumental in the Bank’s growth from $1 billion in assets to $35 billion. He was the CEO of GeoPoll, a leading market research company in developing world countries, and was Managing Director of MBH Enterprises, a private equity company focused on technology and infrastructure investments. He holds a JD/MBA from Columbia University and a BA from Tufts University.
HEATHER COX
Director
Heather Cox was most recently the Chief Digital Health and Analytics Officer for Humana. In this role, Heather was accountable for building Humana’s digital care delivery operations and leading enterprise advanced analytics, including the application of Artificial Intelligence at scale in healthcare.
Prior to joining Humana, Heather served as Chief Technology and Digital Officer at USAA, where she led the teams responsible for designing and building personalized and digitally enabled end-to-end experiences for USAA members. Heather has also designed, built, and served as CEO of Citi FinTech at Citigroup, building a fintech start-up that allowed the company to harness the innovation in the global fintech ecosystem and to adapt to a future dominated by mobile technology. Before that she, headed Card Operations for Capital One.
Heather was named by American Banker magazine as the #3 Woman to Watch nationally in banking by American Banker Magazine in October 2017. She was also named to American Banker’s Women to Watch list in 2011, 2013 and 2016. In 2015, she was named one of the 10 Most Innovative CEOs in Banking by Bank Innovation, as well as Digital Banker of the Year by American Banker. In 2018, Heather was appointed to the NRG Energy Board of Directors and was elected to the Atlantic Union Bankshares Board of Directors in August 2022.
JESSICA BILLINGSLEY
Director
Jessica is a seasoned executive and innovator with decades of experience in frontier technology. She is named on multiple patents including advancements in supply chain technology and anti-counterfeit solutions using blockchain and NFTs. Her experience includes leading successful public and private companies as CEO and serving on multiple boards of directors. Jessica possesses in-depth expertise in private and public capital markets and has successfully navigated complex transactions to drive growth and business transformation. She is also FINRA securities licensed.
Previously, as Founder, Chairman of the Board, and CEO of Akerna (Nasdaq: KERN), a Software as a Service ag-tech company, she successfully publicly listed, completed multiple accretive acquisitions, maintained market leadership for over a decade, and exited via strategic acquisition. Jessica currently serves on the boards of Gryphon Digital Mining (NASDAQ:GRYP), Nu Energy (NASDAQ:NXU), OARO, and the Young President’s Organization (YPO) Entrepreneurship Network Board.
She has been recognized with numerous awards, including Inc. Top 100 Female Founder and Fortune’s Most Promising Woman Entrepreneur. Her insights and thought leadership have been featured in numerous prominent media outlets, in addition to her active contribution to Entrepreneur and Rolling Stone publications.
SINCERELY,
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OUR REPORTS/RELEASES ARE A COMMERCIAL ADVERTISEMENT AND ARE FOR GENERAL INFORMATION PURPOSES ONLY. WE ARE ENGAGED IN THE BUSINESS OF MARKETING AND ADVERTISING COMPANIES FOR MONETARY COMPENSATION. WE HAVE BEEN COMPENSATED A FEE OF TEN THOUSAND USD BY KING TIDE MEDIA LLC FOR A ONE DAY GRYP AWARENESS CAMPAIGN. NEVER INVEST IN ANY STOCK FEATURED ON OUR SITE OR EMAILS UNLESS YOU CAN AFFORD TO LOSE YOUR ENTIRE INVESTMENT. THE DISCLAIMER IS TO BE READ AND FULLY UNDERSTOOD BEFORE USING OUR SERVICES, JOINING OUR SITE OR OUR EMAIL/BLOG LIST AS WELL AS ANY SOCIAL NETWORKING PLATFORMS WE MAY USE.PLEASE NOTE WELL: DEDICATED INVESTORS LLC AND ITS EMPLOYEES ARE NOT A REGISTERED INVESTMENT ADVISOR, BROKER DEALER OR A MEMBER OF ANY ASSOCIATION FOR OTHER RESEARCH PROVIDERS IN ANY JURISDICTION WHATSOEVER.RELEASE OF LIABILITY: THROUGH USE OF THIS WEBSITE VIEWING OR USING YOU AGREE TO HOLD DEDICATED INVESTORS LLC, ITS OPERATORS OWNERS AND EMPLOYEES HARMLESS AND TO COMPLETELY RELEASE THEM FROM ANY AND ALL LIABILITY DUE TO ANY AND ALL LOSS (MONETARY OR OTHERWISE), DAMAGE (MONETARY OR OTHERWISE), OR INJURY (MONETARY OR OTHERWISE) THAT YOU MAY INCUR. THE INFORMATION CONTAINED HEREIN IS BASED ON SOURCES WHICH WE BELIEVE TO BE RELIABLE BUT IS NOT GUARANTEED BY US AS BEING ACCURATE AND DOES NOT PURPORT TO BE A COMPLETE STATEMENT OR SUMMARY OF THE AVAILABLE DATA. DEDICATED INVESTORS LLC ENCOURAGES READERS AND INVESTORS TO SUPPLEMENT THE INFORMATION IN THESE REPORTS WITH INDEPENDENT RESEARCH AND OTHER PROFESSIONAL ADVICE. ALL INFORMATION ON FEATURED COMPANIES IS PROVIDED BY THE COMPANIES PROFILED, OR IS AVAILABLE FROM PUBLIC SOURCES AND DEDICATED INVESTORS LLC MAKES NO REPRESENTATIONS, WARRANTIES OR GUARANTEES AS TO THE ACCURACY OR COMPLETENESS OF THE DISCLOSURE BY THE PROFILED COMPANIES. NONE OF THE MATERIALS OR ADVERTISEMENTS HEREIN CONSTITUTE OFFERS OR SOLICITATIONS TO PURCHASE OR SELL SECURITIES OF THE COMPANIES PROFILED HEREIN AND ANY DECISION TO INVEST IN ANY SUCH COMPANY OR OTHER FINANCIAL DECISIONS SHOULD NOT BE MADE BASED UPON THE INFORMATION PROVIDED HEREIN. INSTEAD DEDICATED INVESTORS LLC STRONGLY URGES YOU CONDUCT A COMPLETE AND INDEPENDENT INVESTIGATION OF THE RESPECTIVE COMPANIES AND CONSIDERATION OF ALL PERTINENT RISKS. 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Contracts With NASA, Lockheed Martin, And Other Global Business Giants
Overall revenue grew approximately 120% year-over-year to over $3 million, with service contract revenue grew over 4800% year-over-year
KULR Selected by One of the World’s Largest Private Space Exploration Companies for Enhanced Battery Safety Solutions
KULR Technology Group Announces a Strategic Contract with Nanoracks for Advanced Space Battery Development
KULR has partnered with a top US automaker to ensure lithium-ion batteries, using our SafeCASE™ tech, are handled with the highest safety standards for storage and transportation, ready for delivery to any location.
Our last profile exploded 10% overnight after opening at 3.60 and hitting 3.99 the next day during Wednesdays session.
We have another profile that we want you to research immediately. It is sitting at just above .15 and has been seeing a lot activity lately with some recent big news announcements.
Pull up KULR Technology Group Inc (NYSE: KULR) right away and put it on your screen for tomorrow’s session.
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.
RECENT FINANCIAL HIGHLIGHTS
KULR posted another record quarter, the second in a row, adding to the record setting revenue of the second quarter. Revenue for the quarter was approximately $3 million compared to approximately $1.4 million in the third quarter last year.
This represents approximately 120% increase or more than doubling of revenue, comparing the two periods. For the first nine months of 2023. KULR generated approximately $7.5 million of revenue compared to approximately $2.1 million in the first nine months of 2022 for approximately a 245% increase or more than a tripling of revenue, comparing the same periods.
Product revenue this quarter was approximately $1.9 million, up about 38% from the same quarter last year. Our service revenue this quarter was approximately $1.1 million up about 4,800% from the same quarter last year. As Mike mentioned earlier, our service revenue can be viewed as a foreshadowing of scalable product revenue opportunities.
Their gross margin for the third quarter was 44%, up from 33% in the same period last year. Achieving a gross margin in the mid 40s has been a goal of the KULR team. We continue to work to increase our gross margin based on revenue mix, pricing, and additional scale.
Revenue per paying customer in the quarter was almost $170,000, up approximately 94% versus the same quarter last year. For the nine months ending Q3, our revenue per paying customer was over $200,000, up approximately 170% with the number of paying customers growing to 37% up 28% from the same nine-month period last year.
Revenue per employee in the quarter was approximately $43,000, which is up 14% from the second quarter and 70% from the first quarter of this year, indicating increasing human capital productivity.
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 Lands Initial Battery Testing Order for its SafeCASE Product with Leading US Automaker
PUBLISHED
MAR 19, 2024 8:30AM EDT
SAN DIEGO, March 19, 2024 (GLOBE NEWSWIRE) — KULR Technology Group, Inc. (NYSE American: KULR) (the “Company” or “KULR”), a global leader in sustainable energy management, today confirmed its collaboration with a leading U.S. automaker. This partnership focuses 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.
KULR’s CEO, Michael Mo, shared insights on the initiative: “At KULR, we leverage a testing regime as rigorous as that of the KULR ONE project—vital for manned space exploration. By integrating these protocols with our SafeCASE™ and SafeSLEEVE™ products, we ensure that lithium-ion batteries are handled with the highest safety standards for storage and transportation, ready for delivery to any location.”
With the surge in battery utilization across electric vehicles, aerospace, and other sectors, there’s a critical need for scalable and secure transportation solutions. KULR’s patented SafeX product line, encompassing SafeCASE™ and SafeSLEEVE™, addresses this need by facilitating safe, efficient shipping of lithium batteries across an automaker’s multifaceted network of engineering, design, and testing divisions.
This strategic engagement is expected to foster further collaborations, extending KULR’s reach into full EV battery transport, logistics, and battery recycling sectors. The company is set to provide an indispensable enterprise battery transportation platform, streamlining the transfer of battery cells within an OEM or an organization, thereby enhancing efficiency and tracking in the battery management lifecycle.
According to recent forecasts by Precedence Research, the global battery packaging market is on track for significant growth, projected to achieve a market size of USD 201.85 Billion by 2032.
As a technology leader, KULR is at the forefront of providing safe, reliable solutions for lithium-ion battery management, partnering with top-tier companies to foster sustainability and innovation in energy storage and management.
KULR Technology Group Announces a Strategic Contract with Nanoracks for Advanced Space Battery Development
PUBLISHED
MAR 14, 2024 8:30AM EDT
SAN DIEGO, March 14, 2024 (GLOBE NEWSWIRE) — KULR Technology Group, Inc. (NYSE American: KULR) (the “Company” or “KULR”), renowned for its leading-edge lithium-ion battery safety and thermal management technologies, today announced in a landmark development it has been awarded 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. This collaboration marks a significant milestone in KULR’s journey, with the initial contract poised to conclude in April of this year, and production slated to commence later.
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. This partnership not only showcases the aerospace industry’s trust in the KULR ONE Space Platform but also highlights the company’s commitment to innovation and reliability.
KULR has already achieved the first milestone of this contract by delivering the first article prototype battery at the end of 2023, demonstrating its ability to meet rigorous project demands under an accelerated timeline. This initial phase ensures KULR’s battery technology will play a crucial role in powering next-generation satellite applications during critical periods.
Michael Mo, CEO of KULR, expressed his enthusiasm about the collaboration, stating, “Our partnership with Voyager’s Exploration team represents a significant win-win scenario. For Voyager, it brings KULR’s cutting-edge, safe, and innovative battery designs to the forefront of space technology, under an expedited schedule. For KULR, it marks the beginning of what we anticipate will be a fruitful relationship, paving the way for multiple program collaborations in the future.”
Echoing this sentiment, Robbie Harris, Voyager Space; Director of Advanced Concepts (Exploration), highlighted the symbiotic nature of the partnership: “Working with KULR has allowed us to push the boundaries of our battery technology and showcase our commitment to safety, reliability, and performance in the most demanding environments. This collaboration is not just about meeting the immediate needs of a project; it’s about setting the stage for a long-term partnership that will drive innovation in space technology.”
KULR ONE Space, designed for meeting NASA’s exacting standards for manned spaceflight, is poised to expand its influence in the aerospace sector, encompassing both satellite and crewed missions. Boasting state-of-the-art facilities in Webster, Texas, and San Diego, California, KULR is prepared to address the dynamic needs of the aerospace industry, thereby reinforcing its expanding role in promoting the advancement of safe battery technology. The KULR ONE Space Platform anticipates significant growth, offering expedited access to wide-ranging, certified battery solutions that are critical to the rapid advancement of space exploration.
KULR Technology to Deliver Mission-Critical Power Solutions for Leading Global Space Innovator’s Upcoming Missions
SAN DIEGO, Feb. 21, 2024 (GLOBE NEWSWIRE) — KULR Technology Group, Inc.(NYSE American: KULR) (the “Company” or “KULR”), a global leader in sustainable energy management, has announced a groundbreaking development program that will play a pivotal role in the advancement of battery technology to be deployed on space missions scheduled for this year – 2024 – and beyond. KULR, internationally known for its proprietary battery safety and performance methodologies and products, has been 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 KULRand its partner anticipate follow-on orders supporting a significant increase in the frequency and scale of planned space missions.
“KULR is quickly becoming the “go-to” solution for companies who are at the forefront of the industry from both a commercial and innovation perspective,” said Dr. William Walker, CTO of KULR Technology Group. “What we are finding is a need for rapid battery development, in-house production, and in-house qualification to decrease time to flight readiness. The KULR team has welcomed this challenge and adapted both our team and our production solution offerings to accommodate these needs. Our team is excited to be powering the next frontier of space exploration by ensuring that battery systems for these missions meet the highest standards of safety, performance, and on-time delivery.”
With the anticipated growth in both state (US domestic and international) and privately sponsored commercial missions, dependable and secure power solutions are an essential requirement for the industry to achieve its potential. As further evidenced by the announcement of this engagement, KULR is at the forefront of delivering these solutions on commercially demanding time frames.
KULR Secures Exclusive Global License for NASA’s Battery Safety Technology to Service World’s Largest OEM Customers
SAN DIEGO, Jan. 17, 2024 (GLOBE NEWSWIRE) — KULR Technology Group, Inc.(NYSE American: KULR) (the “Company” or “KULR”), a global leader in sustainable energy management, today announced the execution of the exclusive worldwide license agreement for NASA’s large format Fractional Thermal Runaway Calorimeter (“FTRC”). The small format FTRC is NASA’s 2023 Invention of the Year, a technology vitally important in analyzing lithium-ion cell thermal runaway characterization and which was co-invented by NASAalumnus and KULR’s Chief Technology Officer, Dr. William Walker. FTRC testing is a critical testing protocol in order for battery pack manufacturers and their OEM customers to deliver their customers the safest, high-capacity batteries. Without conducting these complex testing protocols, battery pack manufacturers and OEMs are not able to get as complete a picture as to how safe their batteries are.
KULR is now the only entity in the world providing comprehensive fractional thermal runaway calorimetry testing services for every cell type, regardless of capacity or format. This breakthrough win firmly establishes KULR as the de facto industry standard battery testing and design services provider in the world to the largest OEM customers across all industries.
Sole access to this all-important thermal runaway data decisively positions KULR as a crucial strategic partner for OEM customers requiring state-of-the-art battery safety design, testing, storage, and recycling throughout any part or all of the battery’s life cycle. According to Straits Research, the global battery testing equipment market was valued at USD 11.2 billion in 2021 and is anticipated to reach USD 16.5 billion by 2030.
With an exclusive license to NASA’s entire FTRC technology suite, KULR is already serving:
A top global automaker for next generation EV battery safety and testing solutions;
And many other customers across all battery chemistries including silicon anode, solid state, nickel manganese cobalt (NMC), and lithium iron phosphate (LFP).
“Maximizing the benefits of lithium-ion technology means that operation of safe battery assemblies using large format cells is a necessity in industry,” stated Dr. William Walker, Chief Technology Officer of KULR Technology Group, Inc. “We find cells of these sizes primarily in vehicles and in grid storage applications. NASA also utilizes large format lithium-ion cells for energy storage on the International Space Station. Unfortunately, utilization of these cells can be difficult due to the immense amount of energy and gases that are released during a thermal runaway event. These challenges are further compounded when trying to satisfy stringent safety requirements now being levied at regulators across the globe. As a result, this positions the FTRC, regardless of cell capacity or format, as a core and necessary tool for designing safe battery systems.”
KULR Selected by One of the World’s Largest Private Space Exploration Companies for Enhanced Battery Safety Solutions
Company Leverages its KULR ONE Design Solutions Platform for Initial Battery Safety Technology Order
SAN DIEGO, Dec. 27, 2023 (GLOBE NEWSWIRE) — KULR Technology Group, Inc.(NYSE American: KULR) (the “Company” or “KULR”), a global leader in sustainable energy management, today announced it has received an initial purchase order from one of the world’s largest privately held space exploration companies (“Customer”) 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 that includes: Internal Short Circuit (“ISC”) technology, Fractional Thermal Runaway Calorimetry (“FTRC”), bomb calorimetry, and impingement zone mapping, performing a comprehensive cell level characterization of the thermal runaway behavior of the Customer’s cells.
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. According to Spherical Insights & Consulting in a report released in May 2023, the global space exploration market size is expected to grow at a 16.21% CAGR and reach USD 1,879 Billion by 2032.
K1-DS integrates KULR’s deep knowledge and experience in the most challenging environments, such as spaceflight with NASA, which requires what KULR considers the most stringent battery solutions platform globally. The Company is intensely focused on expanding customer engagements within the space exploration market with its K1-DS platform solution and expects further design wins to continue well into next year. Earlier this month, KULR was awarded a critical contract for the accelerated development, testing, and production of a leading-edge space battery for a prominent privately help hardware and in-space services company. That engagement is anticipated to grow into a multi-million-dollar partnership for expanded production in 2024.
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.
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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Coming in only after cardiovascular disease, cancer is the second leading cause of death worldwide; unsurprisingly, oncology is one of the biggest sectors around.
As devastating as cancer is, it’s also a big business. And when cancer and Wall Street collide, it can lead to substantial opportunities to capitalize. It’s no wonder investors are turning their eyes toward healthcare companies specializing in oncology
Precedence Research projects that the global oncology market will increase at a compound annual growth rate of 8.2 percent to reach US$581.25 billion in 2030.
Players in the oncology sector are thriving. Biotech stocks experienced a lift in early December after it was learned that AbbVie will be buying cancer developer ImmunoGen for $10 billion!
Scientific advances are creating new and previously only imaginable ways to treat and prevent diseases.
Anixa Biosciences, Inc. is developing therapies and vaccines that are focused on critical unmet needs in oncology.
ANIX is a clinical-stage biotechnology company developing first-in-class products for cancer treatment and prevention. Anixa’s programs use the body’s immune system to take multiple approaches in fighting cancer—vaccines to prevent cancer, and a CAR-T cell therapy to treat cancer.
The Company’s vaccines focus on immunizing against “retired” proteins found to be expressed in certain forms of cancer. This mechanism has never before been utilized for cancer vaccine development. Anixa’s lead vaccine program targets triple negative breast cancer (TNBC), the most aggressive and lethal form of the disease. Anixa’s second preventative vaccine targets ovarian cancer. The breast cancer vaccine is being studied in a Phase 1 clinical trial with Cleveland Clinic, while the ovarian cancer vaccine is in pre-clinical development. Anixa’s cancer treatment program, also targeting ovarian cancer, explores an immunotherapy using a novel type of CAR-T, known as chimeric endocrine receptor T-cell (CER-T) technology. This therapy is in a Phase 1 clinical trial with Moffitt Cancer Center.
By partnering with world-renowned research institutions on clinical development, Anixa maintains a capital- efficient and low-cost business model that facilitates ongoing identification and examination of emerging technologies in complementary fields for potential development and commercialization.
CEO Amit Kumar and Director Arnold Baskies continue to invest capital in Anixa as we keep building upon our mission to be at the forefront of innovation in developing vaccines to prevent cancer. Get involved: https://t.co/va0zFBNwH1$ANIX
Check out the Insider Buying from Last Friday Which Sparked a 20% Rally in ANIX
Investment Highlights
Robust pipeline in oncology/immunology. Multiple value-creating catalysts for clinical programs over next 12 months: 3 candidates, 2 modalities, 3 indications, 2 clinical trials.
Positive Phase 1 clinical data. Breast cancer vaccine: 75% of women showed immune responses with responses observed at all dose levels. Ovarian cancer immunotherapy: no dose-limiting toxicities observed in 1st cohort.
Strong financial profile. Capital-efficient, low-cost business model with research support from key partners. ~$5-6M annual cash burn since 2017. Cash and equivalents of $24M and $0 debt (10/31/23).
Clean capital structure. 31M common shares outstanding, no preferred shares, and no warrants.
High-value partnerships. Licensing, funding, and collaboration with top-tier, world- renowned research organizations and institutions.
Significant TAM opportunity. ~3.8M breast cancer survivors1. ~230,000 women living with ovarian cancer1. All women potentially eligible for vaccines: ~168M in the U.S. alone.
Proven management and board. Decades of success in starting, building, managing, and investing in technology-related companies. Scientific advisory from renowned doctors in oncology research.
Consistent Insider Buying. Consistent stock purchases by CEO and Board insiders.
The Company’s vaccine portfolio includes a novel vaccine being developed in collaboration with Cleveland Clinic to prevent breast cancer – specifically triple-negative breast cancer (TNBC), the most lethal form of the disease – as well as a vaccine to prevent ovarian cancer.
These vaccine technologies focus on immunizing against “retired” proteins that are expressed in certain forms of cancer.
THE CAR-T METHOD:
The exciting field known as immunotherapy has enabled the development of drugs that modulate the immune system to battle cancer.We know that our bodies, through the function of our immune systems, are able to “cure” cancer. It is now known that some number of cells in our bodies are becoming cancerous all the time. These transformations are driven by many factors including genetics and environment.
Most of the time without us being consciously aware, these cells are destroyed and cleared by our immune system. As our immune function declines with age, some cells are able to survive and eventually become tumors, either liquid or solid. We also know that the tumors themselves have developed mechanisms to suppress immune cell function. Such is the case with pediatric tumors as well adult cancers.
Considering this understanding, the field of immunotherapy tries to boost the ability of our immune cells to battle the cancer. There are a number of methods that scientists have devised to induce our immune systems to battle cancer. One of those approaches is known a Chimeric Antigen Receptor T-cell technology, better known by the acronym, CAR-T.
CAR-T therapy is a treatment where a patient’s T-cells, a type of immune cell, are removed from the body. These cells are then modified in a laboratory through the advanced techniques of genetic engineering, and increased in number, and then infused back into the patient. In many ways, this is the ultimate personalized medicine. The specific genetic engineering is what makes the patient’s own T-cells even more powerful as a tumor fighter. This genetic engineering causes a special receptor to be present on the surface of the T-cell. This receptor is known as the CAR—the Chimeric Antigen Receptor.
The pharmaceutical industry continues to be a hotbed of innovation and CAR-T cell-based compositions are a key innovation area in immuno-oncology!
CAR-T THERAPY FOR OVARIAN CANCER:
The markets for solid tumors are much larger than the markets for leukemias and lymphomas, especially B-cell cancers. Therefore, ANIXfeels that the scope of opportunities for its CAR- T therapy is very large should the company demonstrate efficacy in solid tumors.
ANIX’S FIRST INDICATION WILL BE OVARIAN CANCER, FOLLOWED BY OTHER TUMOR TYPES.
↪Ovarian cancer is the sixth most common cancer in the world, and one of the most aggressive reproductive cancers among women. Most ovarian cancers are diagnosed at late stages (stage 3 or 4) due to the typical absence of symptoms and lack of screening approaches.
↪Late-stage diagnosis results in relatively high risks of recurrence and often poor prognosis. While the five-year survival rate for stage 1 ovarian cancer is over 80%, the corresponding survival rate for Stage 4 cancer is 20%. Worldwide, over 200,000 cases of ovarian cancer are diagnosed annually.
THE FIRST POTENTIAL ANTI-ANGIOGENIC CAR-T THERAPY:
ANIX has an exclusive worldwide license from The Wistar Institute.
The company believes its CER-T approach will work in solid tumors, especially ovarian cancer, where others have failed.
↪FSHR is a unique target
↪FSH is a natural ligand (not synthetic)
↪The company’s approach may provide anti-angiogenic synergy
↪The company’s CAR-T may execute a dual mechanism of action in destroying the tumor
PREVIOUS CHALLENGES:
↪The CAR-T cells may not br susceptible to the highly suppressive tumor microenvironment
↪As the CAR-T cells are destroying vasculature, they make it leakier, enabling simultaneous, localized delivery of oher agents including chemotherapy
↪CAR-T mediated cell death may be more powerful than ther anti-angiogensis drugs
COLLABORATORS INCLUDE:
MOFFITT CANCER CENTER:
Moffitt is dedicated to one lifesaving mission: to contribute to the prevention and cure of cancer. The Tampa-based facility is one of only 49 National Cancer Institute-designated Comprehensive Cancer Centers, a distinction that recognizes Moffitt’s scientific excellence, multidisciplinary research, and robust training and education. Moffitt is a Top 10 cancer hospital and has been nationally ranked by U.S. News & World Report since 1999.
THE WISTAR INSTITUTE CANCER CENTER:
Founded in 1892 as the nation’s first independent biomedical research institute and located on the campus of the University of Pennsylvania, Wistar is an international leader in the biomedical research fields of cancer, immunology and infectious diseases, a National Cancer Institute (NCI)-designated Cancer Center, and part of the NCI’s select network of national cancer research centers, holding an ‘Exceptional’ rating — the highest possible ranking awarded.
Vaccines harness the immune system to keep people safe from infectious diseases. Thanks to broad-based vaccination programs, some of the most terrifying diseases in history, small pox and polio among them, have been eliminated from existence.
Unfortunately, there’s been little success in developing a preventative (prophylactic) vaccine against cancer.
Most vaccines attack pathogens, such as viruses and bacteria. The immune system is better able to assail these agents because they come from outside the body. Cancer, however, is a different matter. The disease is caused by aberrant cells that arise out of our resident cells. That can make it difficult for our immune system to find the diseased cells, especially as advancing age weakens our immune system. Once these aberrant cells gain critical mass, they become cancer.
Despite the lack of success with cancer vaccines, recently gained knowledge about the human immune system has led to the development, approval and commercialization of revolutionary immuno-therapy drugs. These drugs do not attack cancer directly, but rather modulate the immune system in ways that enable it to destroy or dramatically impair cancer cells.
Imagine if we could train the immune system to kill cancer cells as they arise before they form into tumors. Perhaps, we could eliminate the onset of cancer. The difficulty has been to identify an agent that allows the immune system to target malignant cells without harming healthy tissue.
↪Cleveland Clinic researchers have identified a protein called alpha-lactalbumin that is present in healthy breast tissue only when a woman is lactating and disappears when she stops nursing her child. Alpha-lactalbumin is never present on any other cell in the body. However, it does show up in many types of breast cancer, including an aggressive and deadly form of the disease known as Triple Negative Breast Cancer (TNBC).
↪In addition, Cleveland Clinic researchers have identified that the extracellular domain of anti-Mullerian hormone receptor II (AMHR2-ED) is expressed in normal ovaries, and nowhere else in the body, with this expression ceasing after menopause. However, this protein is also expressed in cancerous ovary cells.
↪Cleveland Clinic, has received an “Intention to Grant” notice from the European Patent Office (“EPO”) for the patent application titled “Ovarian Cancer Vaccines.”
BY DEVELOPING VACCINES THAT TARGET ALPHA-LACTALBUMIN AND AMHR2-ED, ANIX FEELS THE IMMUNE SYSTEM CAN DESTROY BREAST CANCER CELLS AND OVARIAN CANCER CELLS, RESPECTIVELY, AS THEY ARISE AND ULTIMATELY PREVENT TUMORS FROM FORMING!
Anixa’s ovarian cancer vaccine targets the extracellular domain of anti-Müllerian hormone receptor 2 (AMHR2-ED), which is expressed in the ovaries but disappears as a woman reaches and advances through menopause. However, AMHR2-ED is expressed again in the majority of ovarian cancers.
THE MARKET FOR PROPHYLACTIC CANCER VACCINES IS SIZABLE, BIGGER IN FACT THAN THE MARKET FOR ANY TYPE OF CANCER THERAPEUTIC. AFTER ALL, DOCTORS ADMINISTER CANCER DRUGS ONLY AFTER A PATIENT HAS BEEN DIAGNOSED, WHILE A VACCINE CAN BE ADMINISTERED TO A FAR WIDER POPULATION.
BREAST CANCER:
In the U.S., nearly 300,000 women are expected to be diagnosed with breast cancer this year.
OVARIAN CANCER:
Ovarian cancer is the sixth most common cancer in the world, and one of the most aggressive reproductive cancers among women. Most ovarian cancers are diagnosed at late stages (stage 3 or 4) due to the typical absence of symptoms and lack of screening approaches. Worldwide, over 200,000 cases of ovarian cancer are diagnosed annually.
PHASE 1 TRIAL FOR BREAST CANCER VACCINE: CONDUCTED BY CLEVELAND CLINIC, FUNDED BY U.S. DEPARTMENT OF DEFENSE (DOD)
AN OPEN-LABEL PHASE 1 DOSE-ESCALATION TRIAL
DESIGN
Participants will receive three vaccinations, each two weeks apart, and will be closely monitored for side effects and immune response
PHASE 1A (IN PROGRESS)
↪18-24 Patients who have been treated for TNBC
↪Safety will be monitored
↪Immune Response will be monitored
↪Maximum Tolerated Dose (“MTD”) determined
PHASE 1B (ENROLLMENT OPEN)
↪Healthy women w/mutations
↪Chosen to undergo prophylactic mastectomy
↪Vaccinate before surgery and evaluate immune response and resected tissue
↪Unique opportunity to garner supplemental data after studying breast tissue to determine if T cells are surveilling the tissue without any visible cancer tumors
PHASE 1C (ENROLLMENT OPEN)
↪Additional cohort combining vaccine with Keytruda
↪Patients treated for TNBC
↪Combine Keytruda w/ vaccine to evaluate if there is synergy
POSITIVE CLINICAL RESULTS AS OF APRIL 2023:
↪Enrollment of women who have had TNBC and have undergone standard of care, but are at risk of recurrence
↪42% of TNBC survivors will relapse within 5 years
↪MTD reached in Q4 2022 § Data from all vaccinated women tested to date presented at AACR in April 2023
↪16 patients dosed through July 2023
↪No safety concerns
↪Immune responses observed at all dose levels
↪All patients had some immune response
↪Intensity of responses varied with patients
IN SUMMARY…
One of the most aggressive and difficult-to-treat ailments, cancer is a disease that involves the uncontrolled division and growth of malignant cells.The goal to prevent the disease or eradicate it has been monumental in big pharma for decades.
With multiple catalysts over the next 12 months across its clinical pipeline, now is a pivotal time to have Anixa Biosciences, Inc. (NASDAQ: ANIX) on your radar. The company has 2 clinical trials in progress, showing positive results!
ANIX highlights:
↪A low-cost business model
↪Developing programs with partners
↪Leveraging existing infrastructure of partners
↪Maintaining low overhead and cash burn
↪Potential to out-license programs to pharma for late stage clinical development and commercialization
Chairman & Chief Executive OfficerDr. Kumar has been an investor, founder, director and CEO of several technology enterprises, both public and private. As CEO, he took CombiMatrix Corporation public and ran it for a decade while listed on the NASDAQ Global Market. He has worked in venture capital with OAK Investment Partners, and has been an advisor to investment funds, venture capital firms, and Fortune 500 companies. He was on the Board of Directors of Acacia Research Corporation from 2002-2008. Dr. Kumar is currently Chairman and CEO of Anixa Biosciences and he sits on the Board of other public and private companies. He has served on the Board of the American Cancer Society since 2016. He received his AB in Chemistry from Occidental College. After graduate studies at Stanford University and Caltech, he received his Ph.D. from Caltech and followed that with a post-doctoral fellowship at Harvard.
MICHAEL CATELANI
President, COO & CFOMr. Catelani is a seasoned executive with over 30 years of finance and operations management experience. He currently serves as President, Chief Operation Officer & Chief Financial Officer of Anixa Biosciences. Previously, Mike cofounded Tacere Therapeutics, Inc., a privately held biotech company, and served as its Chairman, President & Chief Financial Officer until its sale. Prior to Tacere, Mike served on the Board of Directors and was the Chief Financial Officer of Benitec Biopharma Limited, an Australian Stock Exchange-listed biotech company. Mike was Vice President and Chief Financial Officer at Axon Instruments, a leading designer and manufacturer of instrumentation and software systems for biotechnology and diagnostics research. Axon was a U.S. corporation publicly traded on the Australian Stock Exchange. Previously, he was the Vice President of Finance for Media Arts Group, Inc., an NYSE-listed company. Mike has also worked with several early-stage start-ups in a variety of industries, including biotechnology, cleantech and retail, in both advisory and management roles and has served as a contract CFO for a number of established businesses in the biotech field. Mike began his professional career at Ernst & Young and is a CPA (Inactive). He received his BS degree in business administration, with a concentration in accountancy from Sacramento State University and earned his MBA from the University of California, Davis.
PAMELA D. GARZONE, PH.D.
Chief Development OfficerDr. Garzone is a senior pharmaceutical executive with over 25 years of diverse experience in the industry and is recognized for her strategic, scientific, clinical and regulatory leadership in drug development. Prior to joining Anixa, Dr. Garzone held executive roles in clinical development with several companies, including Calibr, a division of the Scripps Research Institute, and Pfizer. She previously held positions of increasing responsibility at companies such as Elan Pharmaceuticals and Genetics Institute, starting her industry career at Genentech. Prior to her industry experience, she was an Assistant Professor, Pharmacy and Therapeutics at the University of Pittsburgh School of Pharmacy. She earned a B.S. degree in Pharmacy from Purdue University and an M.S. in Pharmacy Practice from the University of Pittsburgh. She received her Ph.D. in Clinical Science from the University of Pittsburgh.
SINCERELY,
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Exciting 🚀day! We're acquiring @BeOp_io, adding #AI powered conversational advertising + audience data platform and so much more to our audience ecosystem.
— Collective Audience (@CollectiveAud) March 1, 2024
Hello Everyone,
Last week was certainly a busy one for our members. We profiled 4 companies, all of which went on to make decent moves to the upside. Some have pulled back but not before make acceptable percentage moves into the green.
We have a few companies on our radar that we are excited to put in front of you for this upcoming week.
First on the list is CAUD.
This is another company that we have yet to take a look at.
Collective Audience is a U.S.-based provider of e-commerce and digital customer acquisition solutions that simplifies digital advertising. It provides data-driven, end-to-end marketing through its results solutions or access to data for activating campaigns across multiple channels.
The company’s digital marketing business includes a holistic, self-serve AdTech platform, a proprietary data-driven, AI-powered system that enables brands and agencies to advertise across thousands of the world’s leading digital media and connected TV platforms.
Collective Audience is addressing this opportunity with the launch of an open and interconnected digital advertising and media ecosystem designed to eliminate the many inefficiencies in the digital ad buyer and seller process for brands, agencies and publishers.
Today’s ever-growing, fragmented, digital audience marketing and media landscape is more complex than ever. Creating ways to reach, engage, and convert audiences across numerous channels and formats.
Marketers, now more than ever, need to think about their audience stack and understand which channels are the right ones to leverage, and the most effective strategies to compete for their audiences’ attention.
CAUD brings you all the latest trends, news, and strategies to use from the collective intelligence of its contributors. Who are leaders, doers, and innovators on the front lines of digital media and marketing.
The company is here to empower customers with critical thinking to help them develop, understand, and market to their digital audiences.
Collective Audience to Acquire BeOp, Adding Unique AI-Power, Conversational Advertising and Audience Data Offering to AdTech Ecosystem Platform
NEW YORK, March 01, 2024 (GLOBE NEWSWIRE) — (Nasdaq: CAUD), a leading innovator of audience-based performance advertising and media, has signed a binding letter of intent to acquire BeOp, an award-winning, Europe-based MarTech and AdTech industry-leading innovator.
BeOp brings to Collective Audience a cloud based modular platform. The industry’s first SaaS-, services- and marketplace-based, AI-powered, performance advertising and data platform for media and brands.
BeOp is revolutionizing the advertising landscape with its innovative technology tailored for the new digital media and advertising market KPIs such as attention measurement, engagement rate, attribution and time spent. The platform offers a self-serve interface as well as APIs that enable it to be integrated into any environment.
Retail Media BeOp’s conversational ad units, powered by AI and dynamic ad creatives, captivate users attention. This approach ensures unmatched conversion rates in the retail media domain. With BeOp, every interaction becomes a sales opportunity.
Data BeOp is already integrated with the leading DMPs (data management platforms) in the market. This integration positions Collective Audience at the forefront, offering the unique ability to create exclusive zero and first party segments for media. Empowering publishers for the first time with their data, these functionalities will soon be extended to advertisers, opening up new targeting and customization possibilities.
End of Third-party Cookies With the disappearance of third-party cookies that have been the industry’s primary targeting mechanism, BeOp is positioned as an independent, cookieless solution. Its comprehensive suite of tools for audiences, data, and monetization offers the open web market a powerful solution to address current and future challenges. The combination of Collective Audience and BeOp represents the future of digital advertising.
BeOp’s conversational approach opens up new communication possibilities for brands and media to engage and convert consumers based on their interests. See examples of such conversational ad experiences BeOp created for leading brands, including Range Rover, Tommy Hilfiger and Samsung, here.
BeOp’s expert teams, based in France (Paris and Montpellier) and New York City, work with more than 80% of the top French advertisers and 90% of the country’s premium publishers. Customers also include more than 200 premium global publishers across the UK, North America and Australia, with BeOp helping to generate more than 50 million unique visitors per month.
Since its founding in 2017, the power and effectiveness of BeOp’s unique approach is reflected in its rapid revenue growth, reportedly climbing 35% to US$3.7 million in 2023.
Given the anticipated operational synergies with the existing Collective Audience digital ecosystem, the acquisition is expected to be operationally EBITDA positive upon completion. The additional benefits of scale and cross pollination are also expected to enhance Collective Audience’s overall revenue growth and profitability profile as a part of its rising tide growth model.
BeOp has won numerous awards, including the Innovation Competition by BPI France in 2018, a finalist in the Start & Pulse by Sofinco competition in 2021, and winner of the Cas d’Or du Conversationnel competition in 2022. BeOp was officially certified by the HappyIndex® AtWork in 2022, reflecting employee satisfaction in the company’s work environment.
To advance the relationship and integration process during the closing process, Collective Audience signed an exclusive interim license and joint venture agreement with BeOp for using its conversational advertising technology in North America pending completion of the acquisition.
The companies plan to integrate BeOp’s platform into Collective Audience’s product offering to scale the BeOp’s U.S. market share, with this expected to facilitate an immediate ramp up in revenue generation for Collective Audience.
“Building on our success in Europe, BeOp is now set to conquer the North American market as an integral part of the Collective Audience platform,” stated BeOp co-founder and CEO, Louis Prunel. “Our new strategic partnership and the expected eventual merging of our companies opens up endless opportunities for propelling our technology to new dimensions. We see our combination creating an unprecedented growth opportunity.”
According to Collective Audience CEO, Peter Bordes: “BeOp technology is the most advanced, modern AI plus data-driven AdTech stack we have seen. It solves many of the issues the industry faces with its cookieless targeting and next generation high speed ad serving that empowers publishers with an audience data DMP, along with attention-based ad units that are the highest performing in the industry.”
“We see BeOp as two to three acquisitions rolled into one. Their exclusive integration with our platform positions us at the forefront, giving us the unique ability to create zero and first party audience segments for our supply and demand partners,” Bordes continued. “With this strategic partnership between Collective Audience and BeOp, the future of digital advertising knows no bounds.”
“As our first acquisition as Collective Audience, BeOp is reflective of the numerous highly valuable and successful potential acquisitions and JV partnerships we’re currently pursuing on a fast-track basis,” added Bordes. “We expect to make additional related major announcements over the coming weeks.”
The initial strategic partnership and anticipated acquisition is expected to help Collective Audience and BeOp to tap the vast opportunities in the rapidly expanding and evolving global AdTech market that is projected to grow at a 14.7% CAGR to reach $2.9 trillion by 2031.
Prunel and BeOp co-founder and COO, Nicolas Sadki, have been appointed to Collective Audience’s Advisor Collective, a recently announced strategic advisory community designed to advance the company’s mission of transforming the AdTech, MarTech and digital media industry.
The acquisition is structured as an all-stock transaction with assumption of certain BeOp liabilities and earn-out provisions. It is expected to close in the second quarter of 2024.
The acquisition would be consummated pursuant to a definitive acquisition agreement between Collective Audience and BeOp. While Collective Audience expects the transaction to be completed as agreed, it is dependent on certain closing terms and no assurances can be provided that the transaction will be completed as described.
Additional details and terms related to the planned transaction will be made available in a Form 8-K filed by Collective Audience and available at www.sec.gov.
About BeOp
The BeOp Creative Studio allows everyone to quickly create new advertising campaigns focused on engagement and interaction, incorporating user data collection and attention tracking natively, while functioning perfectly without cookies. This approach reinvigorates advertising on the Open Web by generating widespread consumer engagement, thereby multiplying advertising effectiveness for advertisers and sustainably defending the value of their spaces for publishers.
Data capture integrated from the creative stage is used by the BeOp Creative Studio to develop content for commerce operations, lead generation, data collection, pre-tests, post-tests, and studies—all with just a few clicks.
BeOp is transforming the advertising era: Instead of trying to impose imperative messages and then snatching a click, it seeks what would interest the consumer most and offers to teach them by giving them control. This approach, endorsed by consumers, allows BeOp creations to achieve memorization rates three times higher.
Publishers can integrate BeOp logic at all levels of their organization:
Editorial: Increase time spent by using the BeOp Creative Studio to create quizzes and other elements complementary to their articles.
Marketing / Data: to collect zero and first-party data (newsletter subscriptions, data for advertising retargeting, pre-tests, and post-tests.)
Business: The ad sales team can create its offers from BeOp’s advertising creations and deliver significantly more to its advertisers (performance, interaction data, attention, time spent, brand memorization.)
BeOp’s advertising creations are compatible with dissemination in their existing tools.
Publishers wishing to gain independence can integrate the BeOp Ad Server. Unlike other market solutions designed from the outset in the interest of advertisers and for a cookie-based mode, the BeOp Ad Server is designed in the interest of publishers and was created from the start to function in the new cookieless world. Lightning-fast, it is a valuable complement to existing tools and allows regaining control over advertising spaces and advertisers of all sizes.
BeOp Ad Server allows them to create as many buying platforms as desired (including direct advertiser), while also having as many sales platforms as necessary to match their commercial organization. They can also have access to their peers’ space in overflow if they wish, enabling them to sign deals of all sizes.
Publishers with one site or 10,000 can market, deliver, and track all their advertising campaigns, while better defending the value of their spaces thanks to the performance of BeOp’s advertising creations.
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Cybin Receives FDA Breakthrough Therapy Designation for its Novel Psychedelic Molecule CYB003 and Announces Positive Four-Month Durability Data in Major Depressive Disorder
Cash totaled $39.0 million Canadian as of December 31, 2023
Cybin has a concluded a positive End-of-Phase 2 meeting with the U.S. #FDA for #CYB003, our deuterated psilocybin analogue for the adjunctive treatment of Major Depressive Disorder.
“We are very pleased with the results of our End-of-Phase 2 meeting. Having aligned on key… pic.twitter.com/fjeZ7DLKPn
The buzz continues to rise over psychedelics. There has been a resurgence of interest in psychedelic compounds based on studies demonstrating their potential therapeutic applications in treating post-traumatic stress disorder, substance abuse disorders, and treatment-resistant depression.
The U.S. psychedelics industry is growing with heavy private investment and even with the blessing of the chief U.S. drug-approval agency!
It was last June that the U.S. Food and Drug Administration issued its first-ever draft guidance on psychedelic drug clinical trials in key areas like psychedelic therapy and high-end herbal medicine, providing industry companies with a glimpse at a regulatory roadmap for drug development.
In addition, the psychedelic drugs market is expected to grow from $4.9 billion in 2022 to $11.8 billion by 2029, says U.K.-based Brandessence Market Research. That’s a compound annual growth rate of about 13.5%!
Wall Street has some hidden gems hiding in this growing arena. This includes Cybin, Inc. which trades under the symbol “CYBN”.
CYBN is a clinical-stage biopharmaceutical company on a mission to create safe and effective psychedelic-based therapeutics to address the large unmet need for new and innovative treatment options for people who suffer from mental health conditions.
The company is revolutionizing mental healthcare and is supported by a network of world-class partners and internationally recognized scientists aimed at progressing proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens.
This one has had two key pieces of news in the past few days. You can see on the 10 day chat above that the market certainly reacted.
The U.S. #FDA recently granted Breakthrough Therapy Designation #BTD to Cybin’s #CYB003 for the treatment of Major Depressive Disorder #MDD.
BTD is designed to expedite the development and review of drugs intended to treat a serious condition where preliminary clinical evidence… pic.twitter.com/IOWqGPynp0
Can psychedelic drugs, once banned, help relieve mental illness? Many say yes.
Decades after most hallucinogens were outlawed, researchers are now using them to treat disorders like PTSD, depression, and addiction.
What is CYBN doing?
Cybin is currently developing CYB003, a proprietary deuterated psilocybin analog for the treatment of major depressive disorder and CYB004, a proprietary dDMT molecule for generalized anxiety disorder and has a research pipeline of investigational psychedelic-based compounds.
Positive Data Released…
CYBN reported positive Phase 2 topline results for CYB003, its proprietary deuterated psilocybin analog in development for the adjunctive treatment of Major Depressive Disorder (“MDD”), demonstrating a 79% remission rate from depression –
The company also announced positive topline results from Phase 1 studies of proprietary deuterated dimethyltryptamine (“dDMT”) molecules CYB004 and SPL028, supporting clinical advancement and the successful development of an intramuscular (“IM”) formulation.
New Patents!
CYBN has also strengthened its patent portfolio with the addition of 6 new patents in key jurisdictions.
“During the past three months, we have continued to make exciting progress with positive topline data from our CYB003 and DMT programs,” said Doug Drysdale, Chief Executive Officer of Cybin.
“The data collected from our clinical trials forms the foundation of our next set of value-creating milestones, as we advance our key programs this year. For CYB003, the three-month Phase 2 efficacy data is expected in Q1 and will provide insights into the durability of treatment effect in MDD. Promising outcomes, such as a 79% remission from depression at 6 weeks in our Phase 2 CYB003 trial, and important safety and dosing findings in our Phase 1 dDMT studies, validate our path forward. Plans are underway to initiate a Phase 3 multisite trial of CYB003 for MDD, and with FDA clearance, we are progressing to a Phase 2a study of CYB004 for the treatment of GAD. We are proud of the rapid progress we have made and look forward to the important work ahead of us. We are encouraged by the positive findings across our clinical-stage programs to date and believe we are well on our way to providing more effective and patient-friendly treatment alternatives for a multitude of mental health disorders,” concluded Drysdale.
Cybin Announces Positive End-of-Phase 2 Meeting with FDA for CYB003 in Major Depressive Disorder and Phase 3 Program Design
– With U.S. Food and Drug Administration (“FDA”) alignment on multisite, multinational Phase 3 program design Company expects to commence Phase 3 program around mid-year 2024 –
– 15 U.S. clinical trials sites targeted; European sites to be added –
– Robust and sustained improvement in depression symptoms with CYB003 at four months with 75% of patients in remission from depression after two doses (16mg) –
– Breakthrough Therapy Designation (“BTD”) for CYB003 provides an expedited review pathway and increased engagement with the FDA –
This news release constitutes a “designated news release” for the purposes of Cybin’s prospectus supplements each dated August 23, 2023, to its short form base shelf prospectus dated August 17, 2023, as amended December 22, 2023.
TORONTO–(BUSINESS WIRE)– Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN) (“Cybin” or the “Company”), a clinical-stage biopharmaceutical company committed to revolutionizing mental healthcare by developing new and innovative next-generation psychedelic-based treatment options, today announced a positive End-of-Phase 2 meeting with the FDA for CYB003, its deuterated psilocybin analog for the adjunctive treatment of Major Depressive Disorder (“MDD”).
This program will be the first ever adjunctive Phase 3 deuterated psilocybin analog depression study globally and follows the successful completion of the Company’s Phase 2 study in MDD completed at the end of 2023. The Company has received minutes from its End-of-Phase-2 meeting with the FDA and reached alignment on its Phase 3 program design. The Company intends to commence enrollment for the multinational, multisite Phase 3 program in mid-year 2024. Fifteen U.S. study sites have been targeted, all of which have experience running psychedelic clinical trials and are DEA Schedule I licensed. The preliminary targeting of specific study sites will serve to expedite site initiation. The Company intends to add approximately 8 additional sites in Europe.
The Company has engaged Worldwide Clinical Trials (“Worldwide”), a global, full-service contract research organization with deep expertise managing clinical trials for mental health conditions, including major depressive disorder. Worldwide has a track record of successful patient recruitment for psychedelic trials and global relationships with best-in-class investigative sites. Worldwide has recent experience managing psychedelic studies in psychiatric populations, including clinical trials conducted in the U.S., Canada, United Kingdom, and other European countries, across a range of psychedelic compounds and treatment models.
“We are very pleased with the results of our End-of-Phase 2 meeting with the FDA and appreciate the agency’s thoroughness and guidance during the process. Having aligned on key features of the pivotal program, we look forward to initiating a multisite, multinational Phase 3 program around mid-year,” said Doug Drysdale, Chief Executive Officer of Cybin. “The strength of CYB003’s clinical profile to date, which showed that at four months after dosing, across the two doses, 60% of patients receiving 12mg and 75% of patients receiving 16mg of CYB003 achieved remission from depression symptoms. With positive durability data demonstrating sustained effects up to at least four months, BTD, and alignment with the FDA on our Phase 3 plan, we are positioned to move quickly to progress the program and bring relief and treatment alternatives to people who are desperately waiting,” concluded Drysdale.
CYB003 Phase 3 Pivotal Program Outline
The Phase 3 pivotal program will comprise two adequate and well controlled studies and a long-term extension, designed as follows:
CYB003-002 (n=220): Fixed repeat dose study of 16mg CYB003, with two doses 3 weeks apart compared to two doses of placebo. The trial is designed to replicate the treatment response seen in the Company’s Phase 2 study.
CYB003-003 (n=330): Three-arm fixed repeat dose study of CYB003 (16mg or 8mg), with two doses 3 weeks apart. Each active arm will be compared to two doses of placebo.
The primary endpoint of both studies is the change in MADRS total score from baseline at Week 6, with a secondary endpoint at Week 12, each compared to placebo.
Patients from each of these Phase 3 trials will enroll in a one-year extension study, during which time non-responders and relapsing patients will receive one full cycle of CYB003 16mg (two doses, three weeks apart).
Moderate to severe MDD patients enrolled in both studies (MADRS >/=24) will be on stable doses of background antidepressant medication, positioning CYB003 as a convenient, adjunctive treatment option.
CYB003-002 is anticipated to begin around mid-year 2024, with CYB003-003 anticipated to initiate a few months later. Each study is expected to run for approximately 18-24 months.
Patient recruitment for the Phase 3 program will include a broad MDD population including only patients that are currently on antidepressants. Importantly, patients will not be required to titrate off their background antidepressants which will reduce some of the inherent recruitment challenges seen in other depression studies.
Summary of Positive Four-Month Efficacy Data for CYB003
Robust and sustained improvements in symptoms of depression four months after two doses of 12mg or 16mg of CYB003:
Mean reduction from baseline in the MADRS total score was approximately 22 points from baseline in both dosing cohorts.
Approximately 75% of the patients were responders (>/= 50% improvement in MADRS scores) following two doses of 16mg.
60% of patients on 12mg and 75% on 16mg were in remission from depression following 2 doses (MADRS score
Cybin Receives FDA Breakthrough Therapy Designation for its Novel Psychedelic Molecule CYB003 and Announces Positive Four-Month Durability Data in Major Depressive Disorder
– Breakthrough Therapy Designation (“BTD”) provides an expedited review pathway, as well as increased access to U.S. Food and Drug Administration(“FDA”) guidance on trial design, with the potential to significantly reduce drug development timelines –
– First known BTD granted by the FDA for an adjunctive psychedelic based therapy for the treatment of Major Depressive Disorder (“MDD”) –
– Robust, sustained and statistically significant improvement in depression symptoms at four months with 75% of patients in remission from depression after two doses (16mg) –
– Impressive mean 22-point reduction in Montgomery-Asberg Depression Rating Scale (“MADRS”) score from baseline at four months –
– Data supports progression to a pivotal Phase 3 multinational study of CYB003 in MDD in mid-2024 –
– Achievement of milestones expedites and de-risks CYB003 development program –
– Company to host webcast to discuss CYB003 program updates today at 8:30 a.m. ET –
This news release constitutes a “designated news release” for the purposes of Cybin’s prospectus supplements each dated August 23, 2023, to its short form base shelf prospectus dated August 17, 2023, as amended December 22, 2023.
TORONTO–(BUSINESS WIRE)– Cybin Inc. (NYSE American:CYBN) (Cboe CA:CYBN) (“Cybin” or the “Company”), a clinical-stage biopharmaceutical company committed to revolutionizing mental healthcare by developing new and innovative next-generation psychedelic-based treatment options, today announced that the FDA has granted BTD to CYB003, its proprietary deuterated psilocybin analog in development for the adjunctive treatment of MDD. If approved by the FDA, CYB003 would be the first known adjunctive psychedelic-based therapeutic for the treatment of MDD.
Strong and durable effects 4 months after 2 doses (Graphic: Business Wire)
The Company also announced that its Phase 2 trial of CYB003 in MDD demonstrated robust and sustained improvement in depression symptoms at four months with 75% of participants receiving two 16mg doses achieving remission and no longer showing signs of depression.
These significant milestones reflect the Company’s commitment to advancing cutting-edge treatment options for MDD, marking a transformational moment in the pursuit of regulatory approval.
Breakthrough Therapy Designation Accelerates and De-risks the Path Forward6
BTD provides an expedited review pathway, as well as increased access to FDA guidance on trial design, with the potential to reduce drug development timelines. It is reserved for drug candidates that target serious conditions and demonstrate substantial improvement on a clinically significant endpoint over available therapies. The designation includes all “fast track” program features, as well as more intensive FDA guidance and discussion of the CYB003 development program, including planned clinical trials and plans for expediting the manufacturing development strategy.
The designation of CYB003 as a breakthrough therapy acknowledges the significant unmet medical need for more effective treatments of MDD and supports CYB003’s potential for significant improvements over existing therapies. BTD serves as validation of the Company’s progress to date and is expected to accelerate Cybin’s mission to advance its proprietary next-generation treatment towards new drug approval on an expedited basis.
This designation is supported by the positive topline results from the Company’s Phase 2 study of CYB003 in MDD, which demonstrated an improvement in depression symptoms superior to approved antidepressants and recently reported data with other psychedelics.1
“It is a testament to the hard work and dedication of the entire Cybin team that we have accomplished so much so quickly. The granting of Breakthrough Therapy Designation by the FDA underscores the potential of CYB003 to fill a gap in the treatment landscape for MDD and serves to expedite and de-risk our development program going forward,” stated Doug Drysdale, Chief Executive Officer of Cybin. “This designation provides for a streamlined review process and enhanced engagement with the FDA. With the robust durability data from our Phase 2 study in hand, we are ready to move forward expeditiously. We are grateful for the opportunity to accelerate the development and regulatory review process that this designation affords, as we prepare to advance CYB003 toward a Phase 3 pivotal trial around mid-year.”
“Currently available standard treatments for MDD can be limited in efficacy, remission and response rates, presenting challenges for patients and mental health practitioners alike. CYB003 may have potential to address these challenges, and with the FDA’s Breakthrough Therapy Designation, the regulatory path forward is accelerated,” said Dr. Maurizio Fava, M.D., Chair of the Department of Psychiatry and Psychiatrist-in-Chief at Massachusetts General Hospital.
Positive Four-Month Efficacy Data for CYB003
Robust and sustained improvements in symptoms of depression with two doses of 12 mg or 16 mg of CYB003:
Mean reduction from baseline in the MADRS total score was approximately 22 points from baseline in both dosing cohorts.
Approximately 75% of the patients were responders (>/= 50% improvement in MADRS scores) following two doses of 16mg.
60% of patients on 12 mg and 75% on 16 mg were in remission from depression following 2 doses (MADRS score
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It has been an exciting year in the market thus far. We have profiled many companies this year that have gone on to make some substantial moves. You never know what is going to happen. We definitely have not profiled all winners but we have had several that have gone on to make significant jumps from where we showed you the company. I am going to cherry pick one but lets look at or very first profile of 2024. We showed you COCH on the 4th of January. It had an average trade of 1.91 on the session. On Thursday it hit 11.46 for a potential 500% move in just about 2 months.
Proof our profile from Jan. 4 this year that went on to run 500% over 2 months:
We have another company on our radar that you are going to want to research for Thursday.
This is another company that we have never brought to your attention in the past.
Pull up WETH immediately.
Wetouch Technology Inc. (NASDAQ:WETH) stands as a stalwart in the realm of projected capacitive touchscreens, boasting decades of expertise and a diverse product range tailored to meet the demands of various industries worldwide. With a strong international presence spanning China, South Korea, and Germany, our commitment to quality is underscored by prestigious certifications like ISO9001 and ISO 14001, ensuring our products meet the highest industry standards.
Positioned within the dynamic touch screen display market, WETH is poised for exponential growth, with projections soaring to USD 163.10 billion by 2030. Our robust revenue generation, exemplified by approximately $37.3 million for the nine months ended September 30, 2023, solidifies our market position. Moreover, strategic partnerships with industry giants such as Siemens underscore our credibility and market prowess.
Notably, WETH has outperformed both the US Electronic industry and market returns over the past year, demonstrating resilience and potential for lucrative returns. With growing profit margins and accelerating earnings growth, investors are presented with a compelling opportunity to capitalize on WETH’s trajectorytowards sustained success and market dominance.
TOP REASONS TO HAVE WETH ON YOUR WATCHLIST
1. Industry Expertise: With decades of experience, WETH is a leading player in projected capacitive touchscreens.
2. Diverse Product Portfolio: Offering medium to large-sized touchscreens for various industries including automotive, gaming, and medical.
3. Global Presence: Operating internationally, with strong footholds in China, South Korea, and Germany.
4. Quality Assurance: Committed to industry standards with certifications like ISO9001 and ISO 14001.
5. Revenue Growth: Consistent revenue generation, showcasing stability and market demand. (Revenues: Approximately $37.3 million for the nine months ended September 30, 2023)
6. Strategic Partnerships: Collaborating with renowned clients like Siemens, leveraging industry credibility.
7. Market Outperformance: Exceeded the US Electronic industry and market returns over the past year. (Return vs Industry: 19%, Return vs Market: 31%)
8. Growing Profit Margin: WETH’s current net profit margins (25.8%) are higher than last year (24.2%).
9. Accelerating Growth: WETH’s earnings growth over the past year (8.5%) exceeds its 5-year average (-5.7% per year).
10. Market Potential: Positioned to capitalize on the expanding touch screen display market, estimated to reach USD 163.10 billion by 2030.
11. Track Record of Success: Proven performance with a history of fulfilling orders through sales framework agreements and direct purchases.
10 Day Chart
The chart shows that WETH has seen a significant amount of volatility over the past 10 sessions. It looks like it is sitting right in the median sweet spot heading into Thursday’s session.
Touch Experience with Wetouch Technology Inc. (NASDAQ:WETH)The Future of High-End Touch Screens Worldwide!
Changing Industries with Cutting-Edge touchscreens Solutions Tailored for Financial, Automotive, Medical, Gaming, lottery, POS and More!
Traditional touchscreens lack durability and performance for diverse industries like finance, automotive, and medical. Wetouch offers robust large-format touchscreens tailored for specific industry needs, ensuring durability, precision, and multi-touch capability. Our innovative solutions empower businesses to streamline operations, enhance user experiences, and drive growth effortlessly.
Siemens Industrial Automation
Cutting-edge touchscreen technology, we’ve partnered with industry leaders like Siemens to revolutionize user experiences. Our high-quality projected capacitive touchscreens empower automotive, industrial, and gaming sectors, driving seamless interactions and boosting operational efficiency. Join us in shaping the future of touch interface technology.
Exploring the Lucrative Landscape of the Touch Screen Display Market
The Touch Screen Display Market, valued at USD 65.60 Billion in 2021, is projected to reach USD 163.10 Billion by 2030, with a CAGR of 8% from 2022 to 2030. North America is poised to exhibit the fastest growth. Increasing demand for interactive and user-friendly displays across various industries globally is a key driver for market expansion.
Company Overview
Touch The World Touch The Future
Innovating the Future of Touch Screen Technology
Wetouch Technology Inc. stands at the forefront of touch screen display innovation, offering a diverse range of high-quality products tailored to various industries. Specializing in large-format touchscreens, we deliver cutting-edge solutions for financial terminals, automotive, medical, gaming, and more. Our research focus centers on advancing touchscreen technology to meet evolving market demands.
“At Wetouch, we’re committed to revolutionizing touchscreens to enhance user experiences across industries,” says CEO Zongyi Lian.
With the touch screen display market projected to reach USD 163.10 billion by 2030, Wetouch is strategically positioned to capitalize on this lucrative opportunity.
Wetouch has received ISO certifications and earned accolades for excellence in touchscreen technology. Our partnerships and media coverage underscore our commitment to innovation and quality.
Our products are used and applied in the production of a variety of products in a wide range of industries. Our products’ areas of common application are set out below.
Point of Sale (“POS”) Machines
POS machines, or point of sale machines, are used in a variety of retailers, including in department stores, supermarkets, convenience stores, boutiques, restaurants, hotels, banks, logistics, telecommunication and other service industries. Due to the frequent use of touchscreens on POS machines, Wetouch has adopted the use of high-end materials which give its products’ a competitive advantage through their anti-scratch, high temperature resistance and long use life qualities.
Car Navigators and Entertainment Systems
Touchscreen products for car navigation and entertainment systems take advantage of the popularity of touchscreen consoles in motor vehicles. Wetouch touchscreens are particularly suitable for motor vehicles GPS and entertainment systems, due to their resistance to temperature variation. These touchscreens may be used in both inbuilt and external car systems.
ATM Machines and Other Financial Machines
ATMs and other similar machines use touchscreens or have a touchscreen function. The touchscreens need to have high-endurance capacities as they are used by the general public and are often located outdoors, such that these screens must withstand weathering. Wetouch’s products are particularly suited to use in these machines as they are highly durable.
Industrial Equipment
Touchscreens in the industrial sector have broad application, and play an important role in industrial HMI. Industrial HMI systems and equipment often require touchscreen functions. These touchscreens must be resistant to interference, stable and have good touch sensitivity. Wetouch’s products fully meet these requirements, being temperature variation resistant, dustproof and waterproof.
Gaming Machines
The new generation of gambling machines are commonly adopting a touchscreen function. Gaming machines with a touchscreen function provide an enhanced experience for uses via multi-touch sensory touch systems. Wetouch’s products are therefore popular amongst gambling machine manufacturers.
Lottery Machines
The self-service lottery ticket vending machine is provided with an operator-oriented touch display device, an input device, a modem, a cash register, printer and security authentication function. The touchscreen display facilitates easy and user-friendly operation of the lottery machine.
Ticket Machines and Kiosks
Self-service ticket machines and kiosks contain touchscreen interfaces which are durable and have a long use life. These self-service machines are used in daily lives, and as such there is a continuous demand for high quality and effective touchscreens. Wetouch’s products are widely used in these ticketing machines and kiosks.
Mr. Cai has been our Company’s Chairman and Director since October 12, 2020. Mr. Cai has extensive experience in financing and the touchscreen industry. From August 1992 to August 1996, he worked at Hong Kong Lixin Group, first serving as Financial Manager and later as Financial Director of the group. From September 1996 to June 2003, he worked as Financial Director at Guangdong Midea Group. From July 2003 to December 2015, he worked as Project Manager at Mictouch China, responsible for the research, development, production and sales of infrared touchscreens. In 2006, he co-founded Damai and acted as General Manager, focusing on the research, development, production and sales of high-end five-wire resistive screen. By the end of 2007, Damai was relocated to Chengdu and renamed as Chengdu Wetouch where he works as General Manager. In 2011, he co-founded Sichuan Wetouch and in 2012, he founded Meishan Wetouch. Mr. Cai holds a Bachelor’s degree in Accounting from Sun Yat-sen University and a Master’s degree in Economics from Zhongnan University of Economics and Law. Mr. Cai’s management and extensive experience and his role as founder of Sichuan Wetouch led to the conclusion that he should serve as a director.
Zongyi Lian – Chief Executive Officer and President
Mr. Lian was appointed Chief Executive Officer and President on October 12, 2020. He has served as Chief Executive Officer of Sichuan Wetouch since November 21, 2017. In 2006, he co-founded Chongqing DamaiTouchscreen Computer Co., Ltd (“Damai”) (later renamed Chengdu Wetouch) and served as Vice Technique General Manager. In 2011, he co-founded Sichuan Wetouch and served as Vice Technique General Manager. Mr. Lian holds a Master’s degree in Automatic Control from National Chiao Tung University.
Yuhua Huang – Chief Financial Officer
Mr. Huang was appointed our Chief Financial Officer on October 12, 2020. He concurrently serves as Chief Financial Officer of Sichuan Wetouch, a position he has held since March 2018. From 2010 to 2013, he worked as an accountant at Liugong Group and, from 2014 to 2017, he served as Financial Manager at Shanghai Oriental Pearl Group Co., Ltd. Mr. Huang holds a Bachelor’s degree in accounting from Sichuan Institute of Industrial Technology. He was qualified as a CPA in China in 2004 and as an auditor in 2014, respectively.
Jiaying Cai – Secretary and Director
Ms. Cai has been our Company’s Secretary and Director since June 2020. She concurrently serves as the Chief Executive Officer and director of BVI Wetouch, our wholly-owned subsidiary, since its inception on August 14, 2020. From February 2017 to May 2019, Ms. Cai worked at Chengdu Wetouch Technology Co., Ltd, an affiliate of Guangde Cai, which specializes in the research, development, manufacturing and sales of capacitive touchscreens widely used in HMI and military industries, where she served as staff within the financial department, human resources department and purchasing department. In April 2020, she joined Chengdu Haobot Technology Co., Ltd and has been serving as its Legal Representative and General Manager until present. Ms. Cai holds a Bachelor’s degree in Music from The Sichuan Conservatory of Music and an EMBA degree from Sichuan University. Mr. Cai’s role at Chengu Wetouch led to the conclusion that she should serve as a director.
Jing Chen – Independent Director
Ms. Chen was appointed to our Company’s Board of Directors, effective November 12, 2021. She serves as the Group Vice President of Future Fintech Group Inc. (Nasdaq: FTFT). From May 2019 to November 2020, Ms. Chen served as the CFO of Future Fintech Group Inc. She served as the CFO of AnZhiXinCheng (Beijing) Technology Co., Ltd. from August 2018 to May 2019. Ms. Chen is an Independent Director of Hello iPayNow(Beijing) Company Ltd. since April 2019. From August 2017 to July 2018, she served as CFO of Beijing LogisTechnology Development Co., Ltd., a company listed on The National Equities Exchange and Quotations Co., Ltd. of China, which is a Chinese over-the-counter stock trading system. From June 2016 to July 2017, Ms. Chen served as Group Chief Financial Officer of Beijing AnWuYou Food Co., Ltd. Ms. Chen served as Chief Financial Officer of Beijing DKI Investment Management Co., Ltd. from August 2012 to May 2016. Ms. Chen received a Doctorate of Business Administration from Victoria University, Neuchatel, Switzerland and an MBA degree from City University of Seattle in Washington, U.S. Ms. Chen holds Fellow Membership of CPA Australia (FCPA), Fellow Membership of the Association of International Accountants U.K. (FAIA) and is a Member of the Chartered Institute of Management Accountants (CIMA). She is also a Senior Member of the International Financial Management (SIFM) accredited by the Ministry of Human Resources and Social Security of PRC. The Board believes Ms. Chen’s extensive public company and accounting experience makes her a valuable addition to the board.
Wang Wei – Independent Director
Mr. Wang was appointed to our Company’s Board of Directors, effective November 12, 2021. He has served as Vice Director of the Investment Banking Department of Chengdu Energy Investment Group since 2017. From 2007 to 2017, he has served as the Head of Technology (Touchscreen) of Ofilm Group, specializing in touchscreen R&D and process engineering management. Mr. Wang holds a BS in Engineering from the University of Electronic Science and Technology of China. The Board believes Mr. Wang’s extensive knowledge and background with regard to touchscreen technology and management makes him a valuable addition to the Board.
Jeffrey Kone – Independent Director
Mr. Kone was appointed to our Company’s Board of Directors, effective November 12, 2021. He has served as the founder of The Wall Street Resource, LLC, a podcast platform for public companies since 2019. From 2003 to 2019, Mr. Kone served as the Managing Member of Wall Street Capital Partners, L.P., an investment fund. From 1984 to 1994, he served as a broker at E.F. Hutton & Co., Merrill Lynch, and Roth Capital. Mr. Koneholds a BS in Business from the University of Southern California. The Board believes Mr. Kone’s extensive experience in corporate finance and investment makes him a valuable addition to the Board.
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Developing Orphan Drug Therapies To Slow Progressive Kidney Disease
XRTX has a strong cash position of $5.2 Million USD – runway for 14 months
First-in-class Product Candidate Ready for Ph3 Clinical Trials of Xanthine Oxidase Inhibitor for ADPKD
Short-term catalyst for the share price: signing of a global licensing deal in 2024 may provide non- dilutive funding during pivotal registration clinical trial with approximately 200 patients
Hello Everyone,
We have another profile that is flying under the radar right now.
We have never profiled this one here. Actually, I haven’t seen this one on any of the industry newsletters that I follow.
Pull up XRTX immediately.
According to finviz, XRTX has a float under 3Mill right now.
This could explain as to why have seen this one take a Giant leap forward and hold it’s gains so far.
XORTX Therapeutics Inc. is a biotechnology company with three drug development programs, two of which are clinically advanced products under development – XRx-008 for Autosomal Dominant Polycystic Kidney Disease (ADPKD), XRx-101 for Coronavirus / COVID-19 infection and XRx-225 for Type 2 Diabetic Nephropathy (T2DN). XORTX is working to advance its clinical development stage products – XRx-008 and XRx-101 – that target xanthine oxidase to inhibit production of uric acid. The Company has a growing portfolio of intellectual property and in some cases claims within granted patents has established proof of concept through independent clinical studies.
XORTX’s pipeline includes proprietary and novel product candidates currently in clinical development:
XRx-008 is being developed as a treatment of progressive kidney disease in Autosomal Dominant Polycystic Kidney Disease (ADPKD).
XRx-101 to treat acute kidney injury as well as health consequences associated with Coronavirus / COVID-19 infection.
About Autosomal Dominant Polycystic Kidney Disease
Autosomal Dominant Polycystic Kidney Disease (ADPKD) is a common life-threatening genetic disease, affecting many individuals in all parts of the world. ADPKD is a progressive kidney and cardiovascular disease. Cardiovascular disease is the leading cause of premature mortality in patients with ADPKD, with over 80% of deaths attributable to coronary artery diseases. In ADPKD Patients high serum uric acid (hyperuricemia) and high blood pressure (hypertension) are considered independent risk factors predicting poorer prognosis.
How Hyperuricemia and Hypertension Contribute to ADPKD
Hyperuricemia and hypertension are frequently early events in the progression of ADPKD and accompany the development of kidney cyst growth and kidney volume expansion. Together these precede the development of reduced kidney function. Hypertension is present in about half of all patients ages 24-30, and in all patients who reach kidney failure.
The high prevalence of hypertension is considered to contribute to the excess risk of cardiovascular disease in ADPKD patients. Experimental data from animal studies suggest that processes such as inflammation, renin-angiotensin-aldosterone system, insulin resistance, and endothelial dysfunction may be involved in the pathogenesis of the disease.
This combination of risk factors is not unlike those observed in models of hyperuricemia and may directly contribute to vascular pathology seen in these patients or may be pathway factors via which hypertension leads to kidney disease progression and cardiovascular disease. Moreover, the causative effect of high serum uric acid on high blood pressure in new-onset hypertension has been reported, in the peer-reviewed journal, ‘Hypertension’, by Feig et al.
Providing ADPKD Patients with New Opportunities
The goals of our treatment of ADPKD are to slow the progression of kidney damage and control related complications. Varied therapeutic strategies targeting ADPKD have been explored such as tight blood pressure control using various inhibitors of the renin-angiotensin-aldosterone system (RAAS) as well as preventing the progressive decline of glomerular filtration rate (GFR) – HALT trial. None of these therapies so far appear to slow the progression of kidney disease due to ADPKD. Transplantation or dialysis may be the only options available once end-stage renal disease develops. Insulin resistance and diabetes are also serious concerns for patients with ADPKD.
ADPKD – Only One Therapy is Approved While Suboptimal Treatment Options Remain
160,000 patients diagnosed with ADPKD in the US (1)
ADPKD is the largest kidney disease market with a genetic origin
A majority of ADPKD patients require dialysis or kidney transplantation
Otsuka’s JYNARQUE® (tolvaptan) was approved in 2018 for the treatment of ADPKD with black box warning – “for risk of serious liver injury”.
Annual Treatment Cost of JYNARQUE® (tolvaptan) ~156,000 USD. Otsuka reported 2022 sales of tolvaptan of $962 m USD. More than ~7,000 ADPKD patients have been treated with tolvaptan (2)
95% of ADPKD patients can’t take or tolerate JYNARQUE® (tolvaptan) (3)
XORTX Submits a New Patent for the Treatment of Chronic Kidney Disease
PUBLISHED
JAN 3, 2024 7:00AM EST
CALGARY, Alberta, Jan. 03, 2024 (GLOBE NEWSWIRE) — XORTX Therapeutics Inc. (“XORTX” or the “Company”) (NASDAQ: XRTX | TSXV: XRTX | Frankfurt: ANU), a late-stage clinical pharmaceutical company focused on developing innovative therapies to treat progressive kidney disease, announces submission of a new patent for the treatment of chronic kidney disease (“CKD”). This patent is designed to protect new discoveries and strategies for the treatment of individuals with varied degrees of kidney function in the setting of CKD. Importantly, this patent entitled “Oral and Sublingual Formulations of Xanthine Oxidase Inhibitors and Methods of Treating Disease” outlines new formulations and methods for safer and more effective the use of xanthine oxidase inhibitors (XOI) in the setting of CKD in particular autosomal dominant polycystic kidney disease (ADPKD), diabetic nephropathy (DN), IgA nephropathy, lupus nephritis and focal segmental glomerulosclerosis.
The positive topline results from the XRX-OXY-101 bridging pharmacokinetic clinical study reported in Q1 2023 (the “Study”) characterized the pharmacokinetics of the Company’s proprietary formulation of oral oxypurinol, XORLO™. Results from the Study showed that XORLO™ was well tolerated by the 88 subjects who received the drug. There were no safety concerns during the testing of drug across the various dosing regimens used. Overall results were positive and showed: i) a substantial increase in the bioavailability of oxypurinol with the XORLO™ formulation platform; (ii) a substantially increased dose proportionality compared to non-formulated oxypurinol; (iii) a multiple dosing regimen that achieved therapeutic target values. In simple terms, substantially increased early oral absorption of XORLO™, and increased circulating concentrations of oxypurinol necessary to inhibit production of uric acid across the desired therapeutic range and thereby slow down the advancements of CKD. Each of these results will provide key data to facilitate precise dosing recommendations for upcoming registration trials in individuals with progressing kidney disease due to ADPKD as well as other causes of CKD.
Dr. Allen Davidoff, CEO of XORTX, commented, “The Bridging Pharmacokinetic Study reported this year provided a wealth of clinical data regarding the potential substantive benefit of the novel formulations of the xanthine inhibitor class of drugs. Analysis of this data set, the use of in silico based pharmacokinetic modeling of data from the XRX-OXY-101 clinical trial, and further innovation, resulted in a deeper understanding of how to address the challenges of dosing in progressing kidney disease. This patent application is intended to claim new opportunities to enhance how the xanthine oxidase inhibitor class of drugs may be dosed in the future. Importantly, how to further improve the safe and effective administration of this class of drugs, including oxypurinol.”
About the XRx-008 program
Oxypurinol is a purine based XOI with important pharmacologic characteristics ideal for administration to individuals with ADPKD. Key pharmacologic attributes include:
1/ the ability to act in the circulation, kidney and cardiovascular tissue and inhibit the production of uric acid and so attenuate the mechanism of injury and accelerating effect of XO on progressing diseases.
2/ XORTX’s proprietary formulation of oxypurinol, XORLO™, provides substantially increased absorption of oxypurinol. Metabolism of oxypurinol is minimal and it is eliminated by the kidneys unchanged. This approach provides an effective, well tolerated drug with an extensive clinical safety experience suggesting the Company’s XRx-008 program has the capacity to provide superior XOI to slow the accelerating decline kidney function in patients ADPKD with coexistent hyperuricemia.
Dr. Allen Davidoff (15 years drug development experience) is the founder and CEO of XORTX. Allen has a broad range of clinical and regulatory experience and senior management experience in pharmaceutical R&D including two investigational new drug (“IND”) applications or supplemental IND’s, two phase I studies (four of which were multi-country), seven phase II studies, and one NDA. Prior to forming XORTX, Allen was the Chief Scientific Officer, VP Product Development and co-founder of Stem Cell Therapeutics Corp. (seven years) ( Trillium TRIL:NASDAQ) and Senior Scientist and Head of Pharmacology at Cardiome Pharma Corp.
James Fairbairn
Interim Chief Financial Officer
James Fairbairn was the Company’s Chief Financial Officer from November 2018 through July 2021. He has more than 20 years of experience with publicly-traded companies. He is a Chartered Professional Accountant, having obtained his CPA designation in 1987 and an Institute-certified Director. Jim Fairbairn holds a B.A. from the University of Western Ontario.
Dr. Stephen Haworth
Chief Medical Officer
Dr. Haworth brings to XORTX 25+ years of successful global drug development and senior leadership in both start up and Fortune 500 pharmaceutical firms in both the US and Europe. Stephen has a broad clinical and regulatory experience that ranges from infectious disease through nephrology, cardiovascular disease and most recently on programs for treatment and prevention of SARS-CoV infection. He has held key roles in numerous FDA and EMA submissions and has been involved in several licensing and M&A transactions. Dr. Haworth holds a medical degree from University College Hospital Medical School, University of London having graduated with Honors.
Dr. David MacDonald
Chief Technology Officer
Dr. MacDonald has an over 30-year record of achievement in drug development and leadership in pharma and biotech, achieving critical, value-inflection milestones for those companies. Prior to XORTX, Dr. MacDonald held positions as CTO and later President of MSI Methylation Sciences Inc. a clinical-stage pharmaceutical company (“MSI”). As CTO David led R&D, pharmaceutical product and clinical development. Prior to his position at MSI, David acted as President and CEO of Active Pass Pharmaceutics. In addition, he has held leadership positions in several small and large pharma biotech companies during which he was responsible for a broad range of technical departments and stages of development covering basic research, IND-enabling studies, formulation, CMC, clinical trials, intellectual property, and regulatory submissions and inspections. Dr. MacDonald is an inventor on over 20 patents issued globally and has published 14 manuscripts in peer reviewed journals. He obtained his Ph.D. in Chemistry from the University of Alberta where his research was focused on enzymology.
Dr. Stacy Evans
Chief Business Officer
Stacy Evans, M.D., MBA, is an executive consultant with nearly 25 years of commercial development and business development experience, including 12 years at Pfizer where he led multiple transactions for Pfizer, including significant deal experience in the rare disease space. For the past seven years, Dr. Evans has consulted at an executive level with small to mid-size private and public biopharmaceutical companies, including acting as Chief Business Officer for many clients. Dr. Evans holds a M.D. from McGill University and an Executive MBA from Columbia University.
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IN JUNE, THE FDA GRANTED FAST TRACK DESIGNATION FOR THE ACCLAIM-3 TREATMENT COMBINATION OF REQORSA AND TECENTRIQ AS MAINTENANCE THERAPY IN PATIENTS WITH ES-SCLC WHO DID NOT DEVELOP TUMOR PROGRESSION AFTER RECEIVING TECENTRIQ AND CHEMOTHERAPY AS INITIAL STANDARD TREATMENT
IN AUGUST, THE FDA GRANTED ORPHAN DRUG DESIGNATION TO REQORSA FOR THE TREATMENT OF SCLC
BREAKING NEWS ANNOUNCED TODAY: GENPREX ANNOUNCES FIRST PATIENT DOSED IN PHASE 2A EXPANSION OF ACCLAIM-1 CLINICAL STUDY OF REQORSA® THERAPY IN COMBINATION WITH TAGRISSO® TO TREAT NON-SMALL CELL LUNG CANCER
Genprex Collaborators to Present Positive Preclinical Data on the Use of Reqorsa® and on NPRL2 Gene Therapy Utilizing Non-Viral Oncoprex® Delivery System for the Treatment of Lung Cancers at the 2024 AACR Annual Meeting. Read more: https://t.co/MmkG94ax3D$GNPX#Biotech#AACR
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Genprex, Inc. is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes.
Genprex’s technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes who currently have limited treatment options.
Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches.
Genprex’s oncology program utilizes its proprietary, non-viral ONCOPREX® Nanoparticle Delivery System, which the Company believes is the first systemic gene therapy delivery platform used for cancer in humans.
ONCOPREX encapsulates the gene-expressing plasmids using lipid nanoparticles. The resultant product is administered intravenously, where it is then taken up by tumor cells that express tumor suppressor proteins that are deficient in the body.
The Company’s lead product candidate, REQORSA™ is being evaluated as a treatment for non-small cell lung cancer (NSCLC) (with each of these clinical programs receiving a Fast Track Designation from the Food and Drug Administration) and for small cell lung cancer.
Genprex’s diabetes gene therapy approach consists of a novel infusion process that uses an endoscope and an adeno-associated virus (AAV) vector to deliver Pdx1 and MafA genes directly to the pancreas.
In models of Type 1 diabetes, the genes express proteins that transform alpha cells in the pancreas into functional beta-like cells, which can produce insulin but are distinct enough from beta cells to evade the body’s immune system.
In Type 2 diabetes, where autoimmunity is not at play, it is believed that exhausted beta cells are also rejuvenated and replenished.
GENPREX ANNOUNCES FIRST PATIENT DOSED IN PHASE 2A EXPANSION OF ACCLAIM-1 CLINICAL STUDY OF REQORSA® THERAPY IN COMBINATION WITH TAGRISSO® TO TREAT NON-SMALL CELL LUNG CANCER
Expects to Complete Enrollment of Phase 2a Expansion Study by the end of 2024
Acclaim-1 Study Has FDA Fast Track Designation
AUSTIN, Texas — (Feb. 5, 2024) — Genprex, Inc. (“Genprex” or the “Company”) (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced that in January 2024, the first patient was enrolled and dosed in the Phase 2a expansion portion of the Company’s Acclaim-1 clinical study of Reqorsa® Therapy (quaratusugene ozeplasmid) in combination with AstraZeneca’s Tagrisso® to treat patients with late-stage non-small cell lung cancer (NSCLC).
“We are encouraged by the very promising Phase 1 results in the Acclaim-1 trial, which demonstrated the combination of REQORSA and Tagrisso was well tolerated at all three dose levels with evidence of efficacy observed in patients with non-small cell lung cancer (NSCLC) whose disease has progressed on Tagrisso,” stated Mark Berger, Chief Medical Officer of Genprex. “We are excited to begin the Phase 2a expansion portion of Acclaim-1, which will examine the toxicity profiles of different cohorts as well as efficacy and other clinical endpoints.”
Data from the Phase 1 dose escalation portion of the Acclaim-1 study were presented at the 2023 AACR-NCI-EORTC International Conference for Molecular Targets and Cancer Therapeutics Meeting in October 2023. The data reported results from twelve patients with advanced, epidermal growth factor receptor (EGFR) mutant NSCLC whose disease progressed after Tagrisso treatment. REQORSA was generally well tolerated, as there were no dose limiting toxicities.
While the Phase 1 portion of the clinical trial was designed primarily to assess safety, promising efficacy results were also observed. One patient at the 0.06 mg/kg dose level, previously treated with carboplatin, pemetrexed, and Tagrisso, had a partial remission (PR) by investigator evaluation and treatment is now ongoing in the trial after 28 cycles, which is approximately 19.5 months. Another patient who is at the 0.09 mg/kg dose level, previously treated with Tagrisso, had stable disease and treatment was ongoing after 14 cycles, or approximately 10 months. And a third patient previously treated with cisplatin, pemetrexed, carboplatin, and Tagrisso at the 0.12 mg/kg dose level has stable disease and is continuing to receive REQORSA after 14 cycles, or approximately 10 months. The extended progression free survival (PFS) of each of these patients is consistent with long-term PFS seen in several patients in prior early stage clinical trials of REQORSA, and is not expected with treatment with Tagrisso alone after progression on Tagrisso1. PFS is the primary endpoint of both the Phase 2a expansion portion and the Phase 2b randomized portion of the Acclaim-1 study.
“Advancing Acclaim-1 marks an important milestone for Genprex. We are proud of the progress we have made thus far and are encouraged by REQORSA’s potential to improve outcomes for patients battling NSCLC. We look forward to an interim analysis from the Phase 2a study in 2025 and expect those results will further validate our novel gene therapy approach to treating lung cancer patients,” said Rodney Varner, President, Chairman and Chief Executive Officer at Genprex.
REQORSA, the Company’s lead product candidate, is being evaluated in three clinical trials as a treatment for NSCLC and small cell lung cancer (SCLC). Each of the three lung cancer clinical programs has received a Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the treatment of that patient population, and the SCLC program has also received an FDA Orphan Drug Designation.
About Acclaim-1 Clinical Trial
The Acclaim-1 clinical trial is an open-label, multi-center Phase 1/2 clinical trial evaluating the Company’s lead drug candidate, REQORSA, in combination with Tagrisso in patients with late-stage NSCLC with activating epidermal growth factor receptor (“EGFR”) mutations whose disease progressed after treatment with Tagrisso.
The Phase 1 dose escalation portion of the Acclaim-1 trial has been completed. The Phase 2a expansion portion of the study is expected to enroll approximately 66 patients, half of whom will have received only Tagrisso treatment and the other half will have received Tagrisso treatment and chemotherapy, to determine toxicity profiles of patients with different eligibility criteria, as well as efficacy and other endpoints. There will be an interim analysis following the treatment of 19 patients in each cohort. The Phase 2b randomized portion of the study is expected to enroll approximately 74 patients to be randomized 1:1 to receive either REQORSA and Tagrisso combination therapy or platinum-based chemotherapy. The primary endpoint of the Phase 2b portion of the trial is progression-free survival, which is defined as time from randomization to progression or death. An interim analysis will be performed at 28 events.
About Reqorsa® Therapy REQORSA® (quaratusugene ozeplasmid) for NSCLC and SCLC consists of the TUSC2 gene expressing plasmid encapsulated in non-viral nanoparticles made from lipid molecules (Genprex’s ONCOPREX® Nanoparticle Delivery System) with a positive electrical charge. REQORSA is injected intravenously and specifically targets cancer cells, which generally have a negative electrical charge. REQORSA is designed to deliver the functioning TUSC2 gene to cancer cells while minimizing their uptake by normal tissue. REQORSA has a multimodal mechanism of action whereby it interrupts cell signaling pathways that cause replication and proliferation of cancer cells, re-establishes pathways for programmed cell death, or apoptosis, in cancer cells, and modulates the immune response against cancer cells.
Genprex’s strategy is to develop REQORSA in combination with currently approved therapies and believes that REQORSA’s unique attributes position it to provide treatments that improve on these current therapies for patients with NSCLC, SCLC, and possibly other cancers.
Tagrisso® is a registered trademark of AstraZeneca plc.Acclaim-1 Phase 2a and Acclaim-3 Phase 1 clinical studies opening for enrollment in January 2024
Poised for FDA guidance regarding diabetes gene therapy program in 2024
AUSTIN, Texas — (January 5, 2024) — Genprex, Inc. (“Genprex” or the “Company”) (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today provides a review of its 2023 achievements and a preview of plans for advancing its diabetes and oncology gene therapy programs in 2024.
“We are very proud of what we accomplished in 2023, particularly with the successful completion of the Phase 1 portion of our Acclaim-1 clinical trial in lung cancer,” said Rodney Varner, Chairman, President and Chief Executive Officer at Genprex. “In 2023, we also received a third Fast Track Designation for Reqorsa® Immunogene Therapy from the U.S. Food and Drug Administration, this time in combination with Tecentriq® for the treatment of small cell lung cancer, and REQORSA was also granted Orphan Drug Designation for the treatment of small cell lung cancer. We believe these designations underscore and further validate the potential of REQORSA. Our accomplishments in 2023, which also include process improvements in our manufacturing operations and securing new supplies of REQORSA, sets the foundation for a strong 2024.”
Oncology Gene Therapy Platform
Genprex’s oncology program utilizes its systemic, non-viral Oncoprex® Nanoparticle Delivery Systemwhich encapsulates the gene-expressing plasmids using lipid nanoparticles. The resultant product is administered intravenously, where it is taken up by tumor cells that then express tumor suppressor proteins that were deficient in the tumor. The Company’s lead product candidate, REQORSA (quaratusugene ozeplasmid), is being evaluated in three clinical trials as a treatment for non-small cell lung cancer (“NSCLC”) and small cell lung cancer (“SCLC”), andeach of the three lung cancer clinical programs has received a Fast Track Designation from the FDA for the treatment of that patient population.
REQORSA has a multimodal mechanism of action whereby it interrupts cell signaling pathways that cause replication and proliferation of cancer cells, re-establishes pathways for apoptosis (programmed cell death) in cancer cells, and modulates the immune response against cancer cells. In early studies, REQORSA has been shown to be complementary with targeted drugs and immunotherapies. Genprex’s strategy is to develop REQORSA in combination with currently approved therapies and believes that REQORSA’s unique attributes position it to provide treatments that improve on these current therapies for patients with NSCLC, SCLC, and possibly other cancers.
Important events of the year included:
In April, at the 2023 Annual Meeting of the American Association for Cancer Research (AACR 2023), Genprex collaborators presented preclinincal gene therapy data with NPRL2, another tumor suppressor gene, that further validates the ONCOPREX Nanoparticle Delivery System as a platform
In December, Genprex completed the successful production of a new batch of REQORSA thereby securing REQORSA supply for its Acclaim clinical studies
Collaborators submitted abstracts in 2023 and are expecting to present data at the American Association for Cancer Research (AACR) Meeting in April 2024
Acclaim-1:
The Acclaim-1 study is a Phase 1/2 clinical trial that has three portions – a Phase 1 dose escalation which has been completed, a Phase 2a expansion, and a Phase 2b randomized portion. Acclaim-1 uses a combination of REQORSA and AstraZeneca’s Tagrisso® in patients with late-stage NSCLC that has activating epidermal growth factor receptor mutations and progression after treatment with Tagrisso. This novel approach to targeting lung cancer has demonstrated a strong safety profile with early signs of efficacy.
In May, Genprex completed the Phase 1 portion of the Acclaim-1 clinical trial and reported encouraging results. The Acclaim-1 Phase 1 study had no Dose Limiting Toxicities and results established a Phase 2 Recommended Dose, as well as provided data showing efficacy of REQORSA in combination with Tagrisso®
In May, after completion of the Phase 1 portion of the Acclaim-1 trial, the Safety Review Committee (“SRC”) approved advancement from the Phase 1 dose escalation portion of the trial to the Phase 2a expansion portion of the trial
In October, clinical collaborators presented a poster presentation at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics showing the Phase 1 results of the Acclaim-1 study
In January 2024, Genprex expects to open the Phase 2a expansion portion of the Acclaim-1 study for enrollment
Genprex expects to complete the enrollment of 19 patients in each cohort of the Phase 2a expansion portion of the study by the end of 2024
Acclaim-2:
The Acclaim-2 study is a Phase 1/2 clinical trial that has three portions – a Phase 1 dose escalation portion, a Phase 2a expansion portion, and a Phase 2b randomized portion. The Acclaim-2 trial uses a combination of REQORSA and Merck & Co.’s Keytruda® in patients with late-stage NSCLC whose disease has progressed after treatment with Keytruda. Patients are treated at the 0.06 mg/kg dose level in the first cohort of patients and, subject to the Acclaim-2 SRC approval, will be treated at successive dose levels of 0.09 mg/kg and 0.12 mg/kg.
Expanding on the previously granted patents in the U.S., Japan, Mexico and Russia, Genprex was granted patents in Australia, Chile and China to cover the use of REQORSA in combination with immune checkpoint inhibtors, e.g., PD1 and PDL1 inhibitors. These patents are applicable to Genprex’s Acclaim-2 and Acclaim-3 clinical trials.
In the second half of 2024, Genprex expects to complete enrollment in the Phase 1 dose escalation portion of the Acclaim-2 study
Acclaim-3:
The Acclaim-3 study has two portions – a Phase 1 dose escalation portion and a Phase 2 expansion portion. In November 2022 Genprex filed with the FDA the protocol for the Phase 1/2 Acclaim-3 clinical trial using a combination of REQORSA and Genentech, Inc.’s Tecentriq® as maintenance therapy for patients with extensive stage small cell lung cancer (“ES-SCLC”) who develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment. Patients will be treated with REQORSA and Tecentriq until disease progression or unacceptable toxicity is experienced.
In June, the FDA granted Fast Track Designation for the Acclaim-3 treatment combination of REQORSA and Tecentriq as maintenance therapy in patients with ES-SCLC who did not develop tumor progression after receiving Tecentriq and chemotherapy as initial standard treatment
In August, the FDA granted Orphan Drug Designation to REQORSA for the treatment of SCLC
In January 2024, Genprex expects to open the Phase 1 portion of the Acclaim-3 study for enrollment, and expects to complete the Phase 1 portion of the study by the second half of 2024
In the second half of 2024, Genprex expects to start the Phase 2 portion of the Acclaim-3 study
Diabetes Gene Therapy Platform
Genprex’s diabetes gene therapy approach is comprised of an infusion process that uses an adeno-associated virus (“AAV”) vector to deliver Pdx1 and MafA genes directly to the pancreas. In models of Type 1 diabetes, GPX-002 transforms alpha cells in the pancreas into functional beta-like cells, which can produce insulin but may be distinct enough from beta cells to evade the body’s immune system. In a similar approach, GPX-003 for Type 2 diabetes, where autoimmunity is not at play, is believed to rejuvenate and replenish exhausted beta cells. Genprex has exclusively licensed from the University of Pittsburgh of the Commonwealth System of Higher Education (“University of Pittsburgh”) multiple technologies relating to the development of a gene therapy product for each of Type 1 and Type 2 diabetes. In October 2023, Genprex entered into a one-year extension to the August 2022 sponsored research agreement with the University of Pittsburgh. The extension includes a revised research plan to encompass the Company’s most recent technologies to which Genprex acquired exclusive rights from the University of Pittsburgh in July 2023. These include a MafB promoter to drive expression of the Pdx1 and MafA transcription factors that can potentially be used for both Type 1 and Type 2 diabetes. This research is expected to be initially conducted in a Type 1 animal model.
In February, Genprex’s research collaborators at the University of Pittsburgh presented preclinical data in a NHP model of Type 1 diabetes highlighting the therapeutic potential of GPX-002. These data, presented during an oral presentation at the 16th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD 2023), showed statistically significant decreases in insulin requirements, increased c-peptide levels and improved glucose tolerance compared to baseline.
In April, the Company hosted a Key Opinion Leader virtual event, “Novel Gene Therapy to Treat Type 1 Diabetes,” which discussed preclinical data reported at ATTD 2023 supporting gene therapy to treat Ttype 1 diabetes
Finalized the components of the diabetes construct to take forward for nonclinical studies
In December, Genprex submitted a request to meet with the FDA to obtain their guidance on the nonclinical studies needed to file an Investigational New Drug application and initiate first-in-human studies. As a result of the FDA’s response, the Company will continue with its planned additional nonclinical studies before requesting regulatory guidance in 2024 for the IND-enabling studies.
About Genprex, Inc.
Genprex, Inc. is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes. Genprex’s technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes who currently have limited treatment options. Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches. Genprex’s oncology program utilizes its systemic, non-viral Oncoprex® Nanoparticle Delivery System which encapsulates the gene-expressing plasmids using lipid nanoparticles. The resultant product is administered intravenously, where it is taken up by tumor cells that then express tumor suppressor proteins that were deficient in the tumor. The Company’s lead product candidate, Reqorsa® Immunogene Therapy (quaratusugene ozeplasmid), is being evaluated in three clinical trials as a treatment for NSCLC and SCLC. Each of Genprex’s three lung cancer clinical programs has received a Fast Track Designation from the FDA for the treatment of that patient population, and Genprex’s SCLC program has received an FDA Orphan Drug Designation. Genprex’s diabetes gene therapy approach is comprised of a novel infusion process that uses an AAV vector to deliver Pdx1 and MafA genes directly to the pancreas. In models of Type 1 diabetes, GPX-002 transforms alpha cells in the pancreas into functional beta-like cells, which can produce insulin but may be distinct enough from beta cells to evade the body’s immune system. In a similar approach, GPX-003 for Type 2 diabetes, where autoimmunity is not at play, is believed to rejuvenate and replenish exhausted beta cells.
Research And Development Pipeline
Genprex Granted FDA Orphan Drug Designation (ODD) for REQORSA® Immunogene Therapy for the Treatment of Small Cell Lung Cancer https://t.co/zdKg4Vkebf$GNPX
– Addressing unmet medical need in large markets through the buildout of a robust pipeline of new drug candidates and drug combinations.
– Leveraging a gene therapy platform; Genprex’s non-viral ONCOPREX® Nanoparticle Delivery System is designed to deliver a variety of therapeutic genes to fight multiple types of cancer.
– REQORSATM immunogene therapy, the first systemically delivered gene therapy used for cancer in humans, can be combined with top-selling cancer drugs and may improve their benefits.
– Genprex has demonstrated clinical achievement with REQORSA in two clinical trials, showing a favorable safety profile and evidence of efficacy in lung cancer.
– GPX-002, Genprex’s diabetes gene therapy, works to transform alpha cells in the pancreas into insulin producing beta-like cells. A Phase 1 clinical trial could be the first-ever gene therapy tested in humans for diabetes.
– Advancing novel gene therapies in diseases with large markets and unmet needs.
– Two NSCLC trials currently enrolling; both with FDA Fast Track Designations.
– World class academic partners.
CLINICAL TRIALS
ONC-001
EVALUATING THE SAFETY OF REQORSA® IMMUNOGENE THERAPY AS A MONOTHERAPY (COMPLETED)
A Phase 1 dose escalation trial was conducted at The University of Texas MD Anderson Cancer Center evaluating the systemic, intravenous delivery of REQORSA® (TUSC2/FUS1) as a monotherapy in stage IV recurrent, metastatic lung cancer patients. The primary objective of this Phase 1 trial was to assess the toxicity of REQORSA administered systemically and intravenously, to determine the maximum tolerated dose, or MTD, and to determine a recommended Phase 2 dose of REQORSA alone.
THE FIRST SYSTEMICALLY DELIVERED GENE THERAPY USED FOR CANCER IN HUMANS
The study showed for the first time that a tumor suppressor gene can be delivered systemically, intravenously and selectively to a patient’s cancer cells using a systemic nanoparticle vector. Although this trial was not designed to show changes in outcomes, a halt in cancer growth was observed in a number of patients. REQORSA was well tolerated with tumor responses noted in lung primary and metastatic cancers in the liver, pancreas, and lymph nodes. In addition, pre- and post-treatment patient biopsies demonstrated that intravenous REQORSA selectively and preferentially targeted patients’ cancer cells.
Metabolic Tumor Response in a Metastatic Lung Cancer Subject
This subject survived after subsequent therapy more than seven years after the final treatment with REQORSA, to our knowledge, without evidence of cancer progression in the responding sites.
ONC-002
COMBINING REQORSA® IMMUNOGENE THERAPY WITH TARCEVA (ERLOTINIB)
PHASE 1 PORTION COMPLETED; PHASE 2 PORTION NO LONGER ENROLLING DUE TO OUR CHANGE OF FOCUS TO CONDUCT ACCLAIM-1
A Phase 1/2 clinical trial evaluated REQORSA® in combination with Tarceva® in stage IIIB/IV lung cancer patients without an activating EGFR mutation and in patients with an activating EGFR mutation whose cancer has progressed on Tarceva therapy. Patients without the EGFR mutation represent the vast majority of lung cancer patients. However, such patients generally are not candidates for Tarceva therapy.
In the Phase 2 trial combining REQORSA with Tarceva, subjects received REQORSA in combination with Tarceva every 21 days until the occurrence of progressive disease (PD), unacceptable toxicity, withdrawal of consent, or study treatment discontinuation for other reasons, whichever occurred first. We believe that the results from the Phase 2 trial are encouraging. Out of 10 patients, 9 had received 2 or more cycles and were therefore evaluable for response. Four patients had tumor regression. The median duration of response is three months. The disease control rate (CR+PR+SD > 8weeks) was 78%, which substantially exceeds the 7% response rate (with no CRs) and 58% disease control rate reported for the LUX-Lung 1 trial, a clinical trial of Gilotrif (afatinib) in a comparable group of patients.
REQORSA + Tarceva Combination: Phase 2 data in subjects with or without EGFR mutations
ACCLAIM-1
COMBINING REQORSA™ IMMUNOGENE THERAPY WITH TAGRISSO (OSIMERTINIB)
Preliminary analysis of the interim data from the Phase 2 portion of our ONC-002 trial supported our belief that REQORSA™ may provide medical benefit in several subpopulations of NSCLC patients for which there is an unmet medical need, and may provide pathways for accelerated approval by the U.S. Food and Drug Administration, or FDA. Data from our clinical trials, along with our preclinical data, provided the basis for our application for a Fast Track Designation, which was granted by FDA on January 14, 2020.
In granting our Fast Track Designation, the FDA found that REQORSA may provide a benefit over existing therapies for patients whose tumors progress on AstraZeneca’s Tagrisso. The FDA Fast Track Designation is for use of REQORSA in combination with TKI Tagrisso for the treatment of NSCLC patients with EGFR mutations whose tumors progressed after treatment with Tagrisso. We believe that the Fast Track Designation provides a clearly defined pathway toward FDA approval of the combination of REQORSA with Tagrisso.
We initiated the Acclaim-1 clinical trial in June 2021, a Phase 1/2 clinical trial of REQORSA combined with Tagrisso. To learn more about Acclaim-1, please visit ClinicalTrials.gov.
To learn more about scientific evidence and studies supporting REQORSA and the TUSC2 gene, please refer to our TUSC2 Bibliography page.
ACCLAIM-2
COMBINING REQORSA™ IMMUNOGENE THERAPY WITH KEYTRUDA (PEMBROLIZUMAB)
Researchers at MD Anderson Cancer Center have conducted preclinical studies evaluating REQORSA™ in combination with anti-PD1 checkpoint inhibitors, including Merck’s Keytruda.
Positive and encouraging data indicate that REQORSA is synergistic with immunotherapies.
In April 2019, we reported that our collaborators at MD Anderson presented positive preclinical data for the combination of TUSC2 with pembrolizumab, demonstrating that TUSC2 combined with checkpoint blockade was more effective than checkpoint blockade alone in increasing the survival of mice with human immune cells, that had metastatic lung cancer.
In November 2019, we reported that our collaborators at MD Anderson presented positive preclinical data for the combination of TUSC2, pembrolizumab and chemotherapy for the treatment of some of the most resistant metastatic lung cancers. This study found that the combination of TUSC2 increases the effectiveness of pembrolizumab and chemotherapy, and thus, may improve on first-line standard of care for lung cancer.
In May 2020, we entered into a worldwide, exclusive license agreement with The Board of Regents of the University of Texas System on behalf of MD Anderson for the use of TUSC2 in combination with immunotherapies, including Keytruda, and also for the use of TUSC2 in a three-drug combination of TUSC2, immunotherapy and chemotherapy.
In December 2021, we received Fast Track Designation from the FDA for use of REQORSA in combination with the checkpoint inhibitor Keytruda for the treatment of advanced NSCLC patients whose tumors progressed after treatment with Keytruda.
In March 2022, we opened the Acclaim-2 clinical trial for patient enrollment, a Phase 1/2 clinical trial of REQORSA combined with Keytruda. To learn more about Acclaim-2, please visit ClinicalTrials.gov.
To learn more about scientific evidence and studies supporting REQORSA and the TUSC2 gene, please refer to our TUSC2 Bibliography page.
DIA-001
STUDYING GPX-002 IN DIABETIC MICE
Researchers at the University of Pittsburgh have conducted preclinical studies evaluating GPX-002 in diabetic mice models. In vivo mice studies have found that GPX-002 restored normal blood glucose levels for an extended period of time, typically around four months. The duration of restored blood glucose levels in mice could translate to decades in humans.
These researchers are continuing to conduct preclinical studies in diabetic primates. Once sufficient preclinical data has been generated, we expect to begin a Phase 1 clinical trial in diabetic patients, which could be the first-ever gene therapy tested in humans for diabetes.
To learn more about scientific evidence and studies supporting GPX-002 and the Pdx1/MafA genes, please refer to our Pdx1/MafA Bibliography page.
ONCOLOGY COMBINATION TREATMENT APPROACH
Our oncology program uses a modern combinational treatment approach to fight cancer, utilizing our lead drug candidate, REQORSA™ immunogene therapy and our unique, proprietary, non-viral ONCOPREX® nanoparticle delivery system combined with approved targeted therapies and immunotherapies. This enables us to offer hope to large patient populations who would otherwise not be candidates for those therapies or who have become resistant to them.
ONCOLOGY COMBINATION TREATMENT APPROACH
Our research indicates that when REQORSA, our lead drug candidate for non-small cell lung cancer (NSCLC), is combined with targeted therapies such as Tarceva (erlotinib) or Tagrisso (osimertinib) or with immunotherapies such as Opdivo (nivolumab) or Keytruda (pembrolizumab), REQORSA is synergistic with those drugs, meaning that the combination is more effective than either drug alone. We believe that by combining REQORSA with targeted therapies and immunotherapies, we can extend the benefit of these approved lung cancer drugs into the large majority of patients who do not now benefit from them, either because the patients’ tumors do not have the molecular profiles that indicate effectiveness of those drugs, or because the patients have developed resistance to those drugs after receiving them for some period of time.
To learn more about our combination trials utilizing our oncology combination treatment approach, refer to our Pipeline and Clinical Trials pages.
TARGETED THERAPIES
Targeted therapies work by targeting the cancer or disease’s specific gene, protein or tissue that contributes to the disease while sparing normal tissue. Unfortunately, targeted therapies require patients to have an activating genetic mutation specific to the drug. In NSCLC, the vast majority of lung cancer patients do not have the genetic mutations that qualify them for targeted therapies, such as the EGFR or ALK gene. In addition, the few patients who do have the genetic mutation qualifying them to receive targeted therapies are likely to develop resistance to these drugs over time.
In January 2020, we received a United States FDA Fast Track Designation for use of REQORSA in combination with EGFR inhibitor Tagrisso for the treatment of NSCLC patients with EFGR mutations whose tumors progressed after treatment with Tagrisso. The median length of time that patients are treated with Tagrisso before their tumors progress is approximately eighteen (18) months.
IMMUNOTHERAPIES
Immunotherapy is a type of treatment that helps the immune system fight disease. Biomarker testing can help determine if high levels of PD-1/PD-L1 proteins are detected in the patient, signifying that the body’s immune system is not working to fight cancer or disease as it should. These patients could qualify for approved immunotherapies, however, not all patients benefit from immunotherapies.
Genprex is conducting preclinical studies to evaluate REQORSA in combination with checkpoint inhibitors. Preclinical data indicate that Genprex’s lead drug candidate is synergistic with checkpoint inhibitors, such as Merck’s Keytruda, meaning that the combination of drugs may be more effective than checkpoint inhibitors alone. Preclinical data also indicates that a three-drug combination of a checkpoint inhibitor, chemotherapy, and REQORSA may be more effective than the two-drug combination of a checkpoint inhibitor and chemotherapy.
MARKET OPPORTUNITY
AstraZeneca’s Tagrisso had more than $4 billion in worldwide gross sales in 2020, and Tagrisso is AstraZeneca’s highest grossing product. Given Genprex’s Fast Track Designation and Tagrisso’s status as the current standard of care in EGFR-mutated NSCLC, we have prioritized the clinical development of REQORSA in combination with Tagrisso. We believe this regulatory pathway positions us well in the $17.9 billion global lung cancer market, especially given the advantages of our Fast Track Designation status.
Merck’s Keytruda generated more than $14 billion in worldwide sales in 2020, and Keytruda is Merck’s highest grossing product. Keytruda is the standard of care in non-EGFR mutated NSCLC. Genprex plans to initiate a Phase I/II clinical trial evaluating REQORSA in combination with pembrolizumab.
PROGRAMS
LUNG CANCER
CANCER
Cancer is a complex disease that can start in any site in the body when a tissue grows out of control and inhibits the body’s normal functioning. At the cell level, cancer often involves the dysregulation of multiple genes and cellular pathways, leading to the cell’s inability to maintain proper cellular functions. Re-establishing or blocking these pathways can be done through many therapeutic approaches, including gene therapy. More general information about cancer can be found at The American Cancer Society.
LUNG CANCER
Genprex’s oncology program is focused on developing new treatments for cancer. Our initial therapeutic target is lung cancer, including non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC).
According to the World Health Organization in 2020, lung cancer was the leading cause of cancer deaths worldwide, causing more deaths than colorectal, breast, liver, or stomach cancers. In 2020, there were more than 2 million new lung cancer cases and 1.8 million deaths from lung cancer worldwide. In the United States, according to the American Cancer Society, it is estimated that in 2022 there will be more than 236,000 new cases of lung cancer and more than 130,000 deaths from this disease. NSCLC represents 84% of all lung cancers and the five-year survival rate for patients with NSCLC with distant spread is 7 percent. SCLC represents about 13% of lung cancer patients and the five-year survival rate for patients with SCLC with distant spread is 3 percent. With limited benefit from current therapies, we believe there is a significant unmet medical need for new treatments for NSCLC and SCLC in the United States and globally, and we believe REQORSA may be suitable for the majority of lung cancer patients.
DIABETES
DIABETES
Our diabetes gene therapy candidate, GPX-002, is being developed for the treatment of diabetes.
According to the U.S. Center for Disease Control, 37 million Americans, or approximately 11% of the population, have diabetes. It is also believed that more than 96 million Americans have prediabetes, which represents approximately 38% of the U.S. population. The prevalence of this chronic disease is continuing to rise.
Chronic diabetes conditions include Type 1 diabetes and Type 2 diabetes, both of which lead to excess sugar in the blood and can cause serious health problems. Left untreated, high blood sugar levels can damage eyes, kidneys, nerves, and the heart, and can also lead to coma and death.
TECHNOLOGY
REQORSA® IMMUNOGENE THERAPY
THE FIRST SYSTEMICALLY DELIVERED GENE THERAPY USED FOR CANCER IN HUMANS
Our lead product candidate, REQORSA® immunogene therapy (quaratusugene ozeplasmid) for non-small cell lung cancer (NSCLC), uses the company’s unique, proprietary ONCOPREX® Nanoparticle Delivery System, which we believe is the first systemic gene therapy delivery platform used for cancer in humans. In 2020, the FDA granted Fast Track Designation for REQORSA in combination with AstraZeneca’s Tagrisso® (osimertinib) in late-stage NSCLC patients with EFGR mutations whose tumors progressed after treatment with Tagrisso. In 2021, the FDA granted Fast Track Designation for REQORSA in combination with Merck & Co’s Keytruda® (pembrolizumab) in late-stage NSCLC patients whose disease progressed after treatment with Keytruda.
The active ingredient in our lead product candidate, REQORSA, is the TUSC2 gene, a tumor suppressor gene.
REQORSA consists of the TUSC2 gene encapsulated in a nanoparticle made from lipid molecules with a positive electrical charge. REQORSA is injected intravenously and can specifically target cancer cells, which generally have a negative electrical charge. Once REQORSA is taken up into a cancer cell, the TUSC2 gene is expressed into a protein that is capable of restoring certain defective functions arising in the cancer cell. REQORSA has a multimodal mechanism of action whereby it interrupts cell signaling pathways that cause replication and proliferation of cancer cells, re-establishes pathways for programmed cell death, or apoptosis, in cancer cells, and modulates the immune response against cancer cells. REQORSA has also been shown to block mechanisms that create drug resistance.
We believe that REQORSA, unlike other gene therapies, which either need to be delivered directly into tumors or require cells to be removed from the body, re-engineered and then reinserted into the body, is the first systemic gene therapy used for cancer in humans.
OVERCOMING DRUG RESISTANCE
REQORSA is a pan-kinase inhibitor shown to simultaneously inhibit the EGFR and AKT oncogenic kinase pathways in vitro and in vivo. Once the cancer cell takes up the nanoparticle containing TUSC2, it is reprogrammed to die. Resistance to targeted drugs and checkpoint inhibitors develop through activation of alternate bypass pathways. For example, when PD-1 is blocked, the TIM-3 checkpoint is up-regulated. We believe that REQORSA’s multimodal activity will block emerging bypass pathways, reducing the probability that drug resistance develops.
To learn more about scientific evidence and studies supporting REQORSA and the TUSC2 gene, please refer to our Clinical Trials and TUSC2 Bibliographypages.
GPX-002
DIABETES GENE THERAPY
GPX-002, a gene therapy for diabetes, is the most recent addition of our licensed technologies. GPX-002 was developed by researchers at the University of Pittsburgh. Diabetic mice studies have shown that GPX-002 restored normal blood glucose levels for an extended period of time, which could translate to decades in humans. This gene therapy could not only become a new treatment option for millions of diabetes patients who need insulin replacement therapy, but it holds the potential to provide long-term effectiveness, or may even be a cure, for diabetic patients.
The diabetes gene therapy, GPX-002, is comprised of a novel infusion process that uses an endoscope and an adeno-associated virus (AAV) vector to deliver Pdx1 and MafA genes to the pancreas. The genes express proteins that transform alpha cells in the pancreas into functional beta-like cells, which can produce insulin but are distinct enough from beta cells to evade the body’s immune system.
Image source: Osipovich, Anna & Magnuson, Mark. (2018). Alpha to Beta Cell Reprogramming: Stepping toward a New Treatment for Diabetes. Cell Stem Cell. 22. 12-13. 10.1016/j.stem.2017.12.012.
Diabetic mice studies show that the gene therapy restored normal blood glucose levels for an extended period of time, typically around four months. The duration of restored blood glucose levels in mice could translate to decades in humans.
The diabetes gene therapy was developed by Dr. George Gittes, a researcher at the Rangos Research Center at UPMC Children’s Hospital of Pittsburgh, where preclinical research is ongoing. GPX-002 has been tested in vivo in mice and nonhuman primates. Once sufficient preclinical data has been generated, we expect to begin a Phase I clinical trial in diabetic patients, which could be the first-ever gene therapy tested in humans for diabetes.
To learn more about scientific evidence and studies supporting GPX-002 and the Pdx1/MafA genes, please refer to our Clinical Trials and Pdx1/MafA Bibliography pages.
ONCOPREX® NANOPARTICLE DELIVERY SYSTEM
THE FIRST SYSTEMIC GENE THERAPY DELIVERY PLATFORM USED IN HUMANS FOR CANCER
Our oncology drug development program utilizes our unique, proprietary non-viral ONCOPREX Nanoparticle Delivery System, which we believe is the first systemic gene therapy delivery platform used for cancer in humans. This platform, originally developed through collaborative research between the University of Texas MD Anderson Cancer Center and the National Institutes of Health, has been optimized to work with our initial product candidate, REQORSA® immunogene therapy.
DESIGNED TO DELIVER CANCER-FIGHTING GENES SYSTEMICALLY
The ONCOPREX platform has been designed and optimized to deliver cancer-fighting genes into the patient’s body systemically. Using this system, we encapsulate plasmids that express tumor suppressor genes within lipid nanoparticles and intravenously administer the encapsulated plasmids which are taken up by the tumor cells, after which the tumor suppressor genes express proteins that are missing or found in low quantities in the tumor cells. Our nanoparticles are non-immunogenic, allowing repetitive therapeutic dosing and have been clinically shown to deliver molecular kinase inhibitors effectively.
OPTIMIZED PARTICLE SIZE
Our systemic, nanoparticle, non-viral delivery system, which is being used in our clinical trials for the treatment of non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), is designed to be small enough to cross tight barriers in the lungs but large enough to avoid accumulation in the liver, spleen and kidney. The nanoparticles have been shown to be taken up by tumor cells after REQORSA administration at up to 33 times the rate they are taken up by normal cells. The cationic charge of the lipid nanoparticles targets cancer cells, which facilitates endocytosis. Once inside the cancer cell, the TUSC2 gene activates signaling pathways that result in cell destruction or apoptosis.
ENHANCED SAFETY AND EFFICACY DESIGN
We have administered REQORSA to more than 50 patients in Phase 1 and 2 clinical trials using our systemic, proprietary, non-viral delivery system.
A Phase 1 clinical trial showed that systemic, intravenous therapy using the ONCOPREX Nanoparticle Delivery System was shown to selectively and preferentially target primary and metastatic tumor cells, resulting in clinically significant anticancer activity. The nanoparticles are non-immunogenic, allowing repetitive therapeutic dosing and providing extended half-life in the circulation.
Our earlier clinical trials have also shown that the ONCOPREX Nanoparticle Delivery System is well tolerated in humans and can safely deliver high therapeutic doses. We believe the ONC-001 clinical trial was the first systemic gene therapy clinical trial using a nanoparticle delivery system to deliver a tumor suppressor gene.
Genprex’s Diabetes Gene Therapy Program: A Major Step Forward in the Fight Against Type 1 Diabetes https://t.co/j1bZ1dlzZ1$GNPX
Genprex Expands Nonclinical Programs into New Therapeutic Indications with Research Collaborators
PUBLISHED
FEB 7, 2024 8:15AM EST
Reqorsa® Therapy May Be Potential Treatment for ALK-Positive Lung Cancer
Three Collaborators Selected to Present Positive Nonclinical Data on Genprex Oncology Program at the 2024 American Association for Cancer Research (AACR) Annual Meeting
AUSTIN, Texas, Feb. 7, 2024 /PRNewswire/ — Genprex, Inc. (“Genprex” or the “Company”) (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced the expansion of its nonclinical programs into new indications through Sponsored Research Agreements and Material Transfer Agreements with multiple academic research collaborators to study TUSC2, the tumor suppressor gene used in Genprex’s lead drug candidate, REQORSA (quaratusugene ozeplasmid), and NPRL2, another tumor suppressor gene. The new indications being evaluated include ALK-positive lung cancer and other additional programs that are not disclosed at this time.
“We are developing a robust research program to expand the potential tumor targets, and even non-tumor targets, that we may include in future clinical trials for REQORSA,” said Rodney Varner, Chairman, President and Chief Executive Officer at Genprex. “Research indicates that the TUSC2 gene used in REQORSA may benefit many types of cancers and potentially the treatment of other diseases. We are exploring opportunities to treat other cancers in which TUSC2 is often deleted or inactivated, and we are evaluating TUSC2 basic biology to better understand how to use our REQORSA treatment. Finally, we are also exploring the use of another tumor suppressor gene, NPRL2, in cancer treatment using our Oncoprex® Nanoparticle Delivery System.”
Genprex’s expanded nonclinical programs include these additional studies with TUSC2 and NPRL2:
TUSC2 in ALK-EML4 positive translocated lung cancer at the University of Michigan Rogel Cancer Center
TUSC2 in metabolism at Meharry Medical College in Nashville, Tennessee
NPRL2 in lung cancers with a major cancer research center in Houston, Texas
TUSC2 in ALK-EML4 positive translocated lung cancer at the University of Michigan Rogel Cancer Center’s Judith Tam ALK Lung Cancer Research Initiative:
ALK-EML4 positive translocated lung cancer is a subset of non-small cell lung cancer (NSCLC) that impacts young and relatively healthy individuals. Since the discovery of the ALK-EML4 translocation, there has been research into targeting and treating this malignancy, which has led to approval by the U.S. Food and Drug Administration (FDA) of various ALK-targeted therapies including crizotinib, alectinib and lorlatinib. Although these compounds provide significant benefit in treating ALK-EML4-driven malignancies initially, resistance ultimately develops. The 5-year survival rate of ALK-EML4 translocated lung cancers is 40.9%, which is higher than other types of lung cancer but we believe leaves substantial room for improvement.
TUSC2 is a tumor suppressor gene that is frequently deleted in lung cancer. In fact, approximately 82% of all NSCLCs lack or express decreased amounts of TUSC2 tumor suppressor protein. ALK translocations are found in approximately 5% of NSCLCs. Research collaborators at the Rogel Cancer Center’s Judith Tam ALK Lung Cancer Research Initiative are studying the combination of Genprex’s REQORSA, which uses the TUSC2 tumor suppressor gene, with various ALK inhibitors. An abstract submitted by these researchers was accepted for presentation at the 2024 AACR Annual Meeting.
TUSC2 Control of Mitochondrial Metabolism at Meharry Medical College:
The TUSC2 gene is encoded in the cell’s DNA in the nucleus, but the TUSC2 protein resides in the inner membrane of the mitochondria. This suggests that TUSC2 protein may be one way in which the cell controls energy production, which largely occurs in the inner membrane of the mitochondria. In addition, mice lacking the TUSC2 gene in all cells, or TUSC2 knock-out mice, can exhibit a number of characteristics consistent with underlying metabolic abnormalities, including premature aging, aging-associated pathologies, and decreased survival. Thus, researchers at Meharry Medical College have been exploring TUSC2 effects on mitochondrial metabolism and have had their work accepted for presentation at the 2024 AACR Annual Meeting.
NPRL2 in Lung Cancers
Following a presentation on NPRL2 at AACR 2023, additional research has been performed to evaluate the use of lipid nanoparticles containing the tumor suppressor gene, NPRL2, in mouse xenografts with resistant cancers. This work, which validates Genprex’s ONCOPREX Nanoparticle Delivery System technology as a platform, has been selected for a presentation at the 2024 AACR Annual Meeting.
Genprex’s ONCOPREX® Nanoparticle Delivery System, is a novel non-viral approach that utilizes lipid nanoparticles to deliver tumor suppressor genes deleted during the course of cancer development. The platform allows for the intravenous delivery of various tumor suppressor genes, and potentially other genes, to achieve a therapeutic affect without the risk of toxicity often associated with viral delivery systems. Genprex believes this system allows for delivery of a number of cancer-fighting genes, alone or in combination with other cancer therapies, to combat multiple types of cancer.
About Reqorsa® TherapyREQORSA® (quaratusugene ozeplasmid) for NSCLC and SCLC consists of the TUSC2 gene expressing plasmid encapsulated in non-viral nanoparticles made from lipid molecules (Genprex’s ONCOPREX® Nanoparticle Delivery System) with a positive electrical charge. REQORSA is injected intravenously and specifically targets cancer cells, which generally have a negative electrical charge. REQORSA is designed to deliver the functioning TUSC2 gene to cancer cells while minimizing their uptake by normal tissue. REQORSA has a multimodal mechanism of action whereby it interrupts cell signaling pathways that cause replication and proliferation of cancer cells, re-establishes pathways for programmed cell death, or apoptosis, in cancer cells, and modulates the immune response against cancer cells.
Genprex’s strategy is to develop REQORSA in combination with currently approved therapies and believes that REQORSA’s unique attributes position it to provide treatments that improve on these current therapies for patients with NSCLC, SCLC, and possibly other cancers.
GENPREX (NASDAQ:GNPX) RELEASES NEW PATIENT VIDEO INTERVIEW DESCRIBING POSITIVE EXPERIENCE IN CLINICAL
AUSTIN, TX / ACCESSWIRE / June 2, 2023 / A clinical-stage gene therapy company is making splashes in the medical world. Genprex, Inc. (NASDAQ:GNPX) is developing potentially life-changing therapies for patients with cancer and diabetes that have limited treatment options. The company is working with world-class institutions in developing new drugs from the company’s pipeline of gene therapy candidates in order to provide novel treatment approaches. Its oncology program utilizes its proprietary non-viral ONCOPREX® Nanoparticle Delivery System, which Genprex believes is the first systemic gene therapy delivery platform used for cancer in humans. The company’s lead drug candidate is called REQORSA®. The immunogene therapy (also known as quaratusugene ozeplasmid) is for both non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) and uses the company’s unique, proprietary ONCOPREX® Nanoparticle Delivery System. The drug may be helpful for treating patients who have already demonstrated drug resistance to other treatments.
On the heels of the release of recent positive safety and early efficacy data related to the phase 1 portion of its Acclaim-1 phase 1/2 clinical trial for non-small cell lung cancer evaluating REQORSA in combination with Tagrisso, Genprex has released a new patient video featuring an NSCLC patient from the phase 1 portion of its Acclaim-1.
All patients in the trial had disease progression on their previous cancer treatment. In the video, an NSCLC patient who experienced extended Progression Free Survival (PFS) in the trial describes her positive experience taking REQORSA – Genprex’s lead drug candidate which she is still taking – while participating in the phase 1 portion of the Acclaim-1 clinical trial.
“While on REQORSA treatment, my doctor noted that the lung cancer lesions have not grown and there is no new growth,” said the NSCLC patient in the Phase 1 portion of Acclaim-1. “I believe the REQORSA treatment has benefited my life and has increased my time.”
The patient’s positive experience is encouraging – she was able to continue working full-time while participating in the clinical trial. She experienced only minor side effects from REQORSA and so far has experienced more than 10 months of progression-free survival.
NSCLC is the most common type of lung cancer, accounting for about 82% of all cases. While there have been some advances in treatment options for NSCLC, such as chemotherapy, radiation therapy and targeted therapies, the overall survival rate for patients with advanced NSCLC remains low. The five-year survival rate for patients with distant spread is 7%.
Genprex has disclosed favorable preliminary clinical data from the Acclaim-1 clinical trial’s phase 1 dose-escalation segment in an abstract published at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting. The findings show that REQORSA was well tolerated with no dose-limiting toxicities. Furthermore, Genprex reported preliminary evidence of efficacy in the phase 1 portion of the study.
“We are thrilled to have our abstract, which reports positive results from the phase 1 portion of our Acclaim-1 clinical trial, published at the ASCO Annual Meeting,” said Mark Berger, MD, Chief Medical Officer at Genprex. “We are encouraged by the favorable safety profile of REQORSA, as well as the preliminary efficacy data we have observed. In fact, the Safety Review Committee has just approved our advancement into the phase 2 expansion portion of the clinical trial.”
As noted above, the company also announced that its Safety Review Committee (SRC) has approved the advancement of the Acclaim-1 clinical trial to the phase 2 expansion portion of the trial. The SRC has examined the full safety data and has approved the recommended phase 2 dose of REQORSA, which is 0.12 mg/kg, twice the highest dose level delivered in Genprex’s previous clinical trials. This approval is a significant milestone in REQORSA’s development program. The SRC’s recommendation to advance the trial to the phase 2 expansion portion is a significant milestone for REQORSA.
Genprex’s REQORSA drug seems to be a promising innovation in cancer treatment. REQORSA’s unique approach of targeting the tumor suppressor gene TUSC2 sets it apart from other cancer treatments and other genetic medicines. Similar to companies like Bluebird Bio or Editas Medicine Inc., who are developing innovative therapies for rare diseases or using different gene editing techniques for cancer, Genprex’s REQORSA has the potential to be a game-changer in the field of cancer treatment through gene therapy.
Three Collaborators Selected to Present Positive Nonclinical Data on Genprex Oncology Program at the 2024 American Association for Cancer Research (AACR) Annual Meeting
Genprex today announced that on February 2, 2024, the Company will implement a 1-for-40 reverse split of its issued and outstanding common stock, par value $0.001 per share.
Acclaim-1 Phase 1 study had no Dose Limiting Toxicity, and results establish Phase 2 Recommended Dose as well as provide data showing efficacy of REQORSA® in combination with Tagrisso®
Strengthens management team with seasoned regulatory expert to support pipeline of gene therapies for the treatment of cancer and diabetes, including two clinical trials in Non-Small Cell Lung Cancer and one in Small Cell Lung Cancer
Genprex announced the closing of its previously announced registered direct offering to healthcare-focused institutional investors of 7,425,744 shares of the Company’s common stock and warrants to purchase up to 7,425,744 shares of common stock at a combined offering price of $1.01 per share of common stock and accompanying warrant. The offering was priced at-the-market under the Nasdaq rules.
Bell2Bell’s latest podcast features Chairman, President and CEO Rodney Varner and CFO Ryan Confer of Genprex, Inc. (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients living with cancer and diabetes. In this interview, Varner and Confer discuss the journeys that led them to Genprex and the promise of the company’s drug development pipeline.
Third FDA Fast Track Designation Further Validates the Potential of REQORSA
AUSTIN, Texas — (June 28, 2023) — Genprex, Inc. (“Genprex” or the “Company”) (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced that the U.S.
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