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Dear Coeptis Therapeutics Shareholders,
As summer comes to a close, I am pleased to share with you the latest updates and accomplishments at Coeptis Therapeutics. For the scientific and medical community, there's growing awareness, education, and acceptance for what we are achieving with our proprietary technology platform. Internally, our dedication to affecting a paradigm-shifting treatment in oncology remains stronger, more focused, and impactful as ever, with the goal of improving patient outcomes.
OUR MISSION REMAINS STEADFAST
While cell therapy is still in its early stages compared to other medical sciences, traditional autologous treatments—using a patient's own cells— are extremely expensive and therefore are inaccessible to many parts of the population.
At Coeptis, we're committed to making cell therapies safe, effective, and accessible to everyone. Our focus is on allogeneic therapies, which involve creating off-the-shelf cell therapies for universal use, thereby transforming the future of cell therapy by significantly reducing treatment costs.
With the completion of our agreement with Deverra Therapeutics a year ago, Coeptis Therapeutics now owns three proprietary, innovative cell therapy platforms targeting cancer, autoimmune, and infectious diseases. These are a proprietary allogeneic NK (natural killer) cell generation platform from Deverra, the universal SNAP CAR platform from the University of Pittsburgh, and the GEAR (gene-edited antibody-resistant) engineered cell therapy platform from Karolinska Institutet.
Our clinical-phase asset, DVX201, is the first-ever allogeneic, cord-blood derived NK cell therapy generated from pooled donor CD34+ hematopoietic stem and progenitor cells (HSPC) cells. Utilizing this NK cell therapy in Phase 1 clinical trials has indicated that it is well tolerated, with no dose limiting toxicities (DLTs). We are currently preparing next steps with this exciting asset, including selecting the suitable patient population for the upcoming phase of clinical development.
Between the integration of NK cell therapies and SNAP-CAR, our universal, multi-antigen CAR technology that we licensed from the University of Pittsburgh into the Deverra allogeneic immune effector cell generation platform, Coeptis is poised and actively working toward becoming a leader in a much-needed therapy field.
RECENT UPDATES
Despite navigating a challenging market environment, we successfully raised capital to further advance our efforts in pioneering groundbreaking treatments in cell therapy. In June, we achieved an initial closing of $4.3 million in our Series A preferred stock offering, priced at a premium to the market, and subsequently raised an additional $1.3 million in July. This financing round, led by CJC Investment Trust, demonstrates strong investor confidence in our vision and capabilities but also highlights the viability and potential of our initiative. The commitment of our investors, including significant participation from board member Christopher Calise, not only strengthens our balance sheet but also bolsters our innovative cell therapy platforms and long-term growth prospects. Under the terms of this financing, the Series A preferred stock is convertible into common stock at a price of $0.40 per share, subject to certain conditions. Additionally, investors have received an 8.40% equity interest in our newly formed subsidiaries, SNAP Biosciences Inc. and GEAR Therapeutics Inc., that demonstrates the inherent value and potential of our innovative approaches in the cell therapy landscape.
STRATEGIC PARTNERSHIPS CONTINUE TO SPEARHEAD GROWTH
Our commitment to scientific advancement through strategic partnerships continues to yield promising results. Our sponsored research agreement with the Lohmueller and Dieters labs at the University of Pittsburgh has led to significant new findings, including further characterization of the adaptor chemistry, expanding to new antibody adaptors, and performing studies with multi-antigen targeting. Meanwhile, our collaboration with the research team at Deverra has successfully extended the application of the SNAP-CAR technology to NK cells, building on prior achievements with T-cells.
These developments were highlighted at two prominent conferences, where they sparked considerable interest. We remain focused on further optimizing transduction and cell engineering processes and are actively planning future in vivo studies to continue driving innovation in this critical area.
Earlier this year we also expanded our exclusive license agreement with the University of Pittsburgh to include autoimmune indications for the SNAP-CAR T and SNAP-CAR NK platforms, leveraging the unique abilities to target multiple antigens and autoreactive B cells.
RECENT MILESTONES
Our Phase 1 clinical trial for the treatment of COVID-19-related viral infections and enrollment in our Phase 1 clinical trial for r/r AML & High Risk MDS have been completed.
We are pleased to announce the completion of our Phase 1 clinical trial for the treatment of COVID-19-related viral infections and the successful enrollment in our Phase 1 clinical trial for relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndrome (HR-MDS). Our DVX201 platform, which uses natural immune cells (NK) derived from donated cord blood stem cells, is designed to target both serious viral infections, such as COVID-19, influenza, and respiratory syncytial virus (RSV), and oncological conditions like AML. This unique approach utilizes healthy immune cells to potentially enhance the body's ability to combat serious viral infections that can lead to hospitalization, especially during "tripledemic" seasons, by directly infusing NK cells.
Since this is a groundbreaking treatment, our priority is ensuring its safety as we test its ability to treat severe viral infections. With over 20 years of safety data backing the use of cord blood cells, and having combined multiple donations to increase effectiveness, we have administered DVX201 to patients at escalating doses up to nearly 1 billion NK cells, with no observed cytokine release syndrome or infusion toxicities, even at the highest dose. For context, the body normally has around two billion NK cells at any given moment.
As we move forward from Phase 1 trials for COVID-19 and AML/MDS, we will be progressing the clinical development following study closeout, top-line data analysis, and completion of potential, supportive ancillary in-vitro studies.
COEPTIS EXPANDING VISIBILITY AND AWARENESS
To expand our visibility and awareness in both the capital markets and the medical industry, we have actively participated in several key conferences and meetings during the first half of this year.
Allogeneic Cell Therapies Summit 6th Annual Meeting
Oral Presentation at ISCT 2024
2024 American Society of Gene and Cell Therapy (ASGCT) Annual Meeting
Cord Blood Association (CBA)
UPDATE ON NASDAQ LISTING
On July 30, we received a delisting determination letter from Nasdaq indicating that we have not regained compliance with the Minimum Bid Price Requirement. We have requested an appeal of Nasdaq's decision, and a hearing before the Panel is scheduled for September 12. According to Nasdaq Listing Rule 5815(a)(1)(B), our request for a hearing has temporarily stayed the suspension of trading and the delisting of our Common Stock, which will remain listed on the Nasdaq Capital Market at least until the Panel issues a decision following the hearing. We are actively exploring all available options to regain compliance and to maintain our listing on the Nasdaq Capital Market. As such, we will continue to keep you informed as we evaluate the best options available for enhancing the value for our shareholders.
To summarize, our key catalysts over the next few quarters include:
As we reflect on our recent accomplishments, I am filled with both pride and excitement. The progress we've made—ranging from our imminent Phase 1 results for the DVX201 trial to the successful completion of our AML and high-risk MDS study—represents a significant stride forward in our mission. Our ongoing advancements in the SNAP-CAR allogeneic cell program and the strategic steps we're taking with our manufacturing processes further underscore our commitment to innovation and excellence.
Looking ahead, I am optimistic about the opportunities that lie before us. We are well-positioned for a future filled with potential. These efforts, along with other initiatives we are pursuing, will position Coeptis to expand our valuation and enhance shareholder value. We remain committed to delivering on our mission and look forward to sharing more exciting updates on our progress with you soon. Thank you for your unwavering support as we move forward into an exciting new phase of growth.
Regards,
Dave Mehalick
President and CEO
Coeptis Therapeutics Holdings, Inc.
Posted In: COEP