WEXFORD,
Pa., Sept. 5, 2024 /PRNewswire/ -- Coeptis
Therapeutics Holdings, Inc. (Nasdaq: COEP) (the "Company" or
"Coeptis"), a biopharmaceutical company developing innovative cell
therapy platforms for cancer, autoimmune, and infectious diseases,
today issued a shareholder letter from its Chief Executive Officer
Dave Mehalick.
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
- In June of this year, our chief scientific and medical officer,
Dr. Colleen Delaney, delivered two
seminars at the 6th Annual Allogeneic Cell Therapies Summit.
- The Summit, which gathers leaders within the scientific
community, provided an excellent platform to educate peers on
Coeptis's progress, particularly in integrating the cell generation
platform with universal SNAP-CAR technology to reshape the cancer
treatment market.
Oral Presentation at ISCT 2024
- We were selected for an oral presentation titled "Developing a
First-in-Class Universal Allogeneic SNAP-CAR NK Cell Therapy" at
the International Society for Cell & Gene Therapy (ISCT)
2024.
- The presentation highlighted the SNAP-CAR platform technology,
which has shown potential as a "universal" CAR therapy targeting
multiple antigens while potentially avoiding toxicities and relapse
due to antigen loss.
- Supported by research from the University
of Pittsburgh and Deverra Therapeutics, our allogeneic CAR
NK cells offer a safer, more accessible, and cost-effective
alternative to autologous CAR T-cells. Building on the successful
use of SNAP-CAR technology in T-cells, we are developing a
universal allogeneic SNAP-CAR NK cell. This innovation replaces the
antigen-binding domain of a CAR with a SNAP tag enzyme, enabling
the attachment of any antibody with a BG tag to create a targeted,
functional CAR.
- Our presentation represents a significant and meaningful path
forward in advancing our mission to develop a proprietary,
allogeneic cell generation platform aimed at universalizing the
treatment of many debilitating diseases.
2024 American Society of Gene and Cell
Therapy (ASGCT) Annual Meeting
- Our abstract on the development of SNAP-CAR NK cells was
featured as a poster presentation at the ASGCT.
- The data presented focused on the potential of the SNAP-CAR NK
platform to target multiple antigens, with the aim of addressing a
wide range of cancers.
- We are pioneering a first-in-class fully universal targeted
cell therapy by combining a highly scalable and cost-effective cell
generation platform with universal SNAP-CAR technology. The
integration of these two platforms has the potential to
revolutionize cancer treatment by offering fully universal,
antigen-agnostic targeted cell therapies, without the need for HLA
matching.
Cord Blood Association (CBA)
- We are participating in the Cord Blood Connect Conference in
September 2024.
- CBA helps raise awareness and advocates for the safe use of
cord blood to benefit patients and advance medicine.
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:
- Publication of Phase 1 results for DVX201 trial in hospitalized
COVID-19 patients; currently under peer review.
- Phase 1 study for AML and high-risk MDS has concluded; top-line
data expected soon.
- Preclinical and proof-of-concept results anticipated;
initiating scale-up of manufacturing for SNAP-CAR adaptors.
- Selecting a new manufacturing partner capable of late-stage and
commercial production for DVX-201
- Development of a robust Quality System that supports current
clinical operations and future outsourced GMP activities.
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.
About Coeptis Therapeutics Holdings, Inc.
Coeptis
Therapeutics Holdings, Inc., together with its subsidiaries
including Coeptis Therapeutics, Inc. and Coeptis Pharmaceuticals,
Inc., (collectively "Coeptis"), is a biopharmaceutical company
developing innovative cell therapy platforms for cancer,
autoimmune, and infectious diseases that have the potential to
disrupt conventional treatment paradigms and improve patient
outcomes. Coeptis' product portfolio and rights are highlighted by
assets licensed from Deverra Therapeutics, including an allogeneic
cellular immunotherapy platform and DVX201, a clinical-stage,
unmodified natural killer cell therapy technology. Additionally,
Coeptis is developing a universal, multi-antigen CAR T technology
licensed from the University of
Pittsburgh (SNAP-CAR), and the GEAR cell therapy and
companion diagnostic platforms, which Coeptis is developing with
VyGen-Bio and leading medical researchers at the Karolinska Institutet. Coeptis' business model is
designed around maximizing the value of its current product
portfolio and rights through in-license agreements, out-license
agreements and co-development relationships, as well as entering
into strategic partnerships to expand its product rights and
offerings, specifically those targeting cancer and infectious
diseases. The Company is headquartered in Wexford, PA. For more information on Coeptis
visit https://coeptistx.com/.
Cautionary Note Regarding Forward-Looking
Statements
This press release and statements of our
management made in connection therewith contain or may contain
"forward-looking statements" (as defined in Section 27A of the
Securities Act of 1933, as amended, and Section 21E of the
Securities Exchange Act of 1934, as amended). Forward-looking
statements include statements concerning our plans, objectives,
goals, strategies, future events or performance, and underlying
assumptions, and other statements that are other than statements of
historical facts. When we use words such as "may," "will,"
"intend," "should," "believe," "expect," "anticipate," "project,"
"estimate" or similar expressions that do not relate solely to
historical matters, we are making forward-looking statements.
Forward-looking statements are not a guarantee of future
performance and involve significant risks and uncertainties that
may cause the actual results to differ materially and perhaps
substantially from our expectations discussed in the
forward-looking statements. Factors that may cause such differences
include but are not limited to: (1) the inability to maintain the
listing of the Company's securities on the Nasdaq Capital Market;
(2) the risk that the integration of the Deverra licensed assets
will disrupt current plans and operations of the Company; (3) the
inability to recognize the anticipated benefits of the
newly-licensed assets, which may be affected by, among other
things, competition, the ability of the Company to grow and manage
growth economically and hire and retain key employees; (4) the
risks that the Company's products in development or the
newly-licensed assets fail clinical trials or are not approved by
the U.S. Food and Drug Administration or other applicable
regulatory authorities; (5) costs related to integrating the
newly-licensed Deverra assets and pursuing the contemplated asset
development paths; (6) changes in applicable laws or regulations;
(7) the possibility that the Company may be adversely affected by
other economic, business, and/or competitive factors; and (8) the
impact of the global COVID-19 pandemic on any of the foregoing
risks and other risks and uncertainties identified in the Company's
filings with the Securities and Exchange Commission (the "SEC").
The foregoing list of factors is not exclusive. All forward-looking
statements are subject to significant uncertainties and risks
including, but not limited, to those risks contained or to be
contained in reports and other filings filed by the Company with
the SEC. For these reasons, among others, investors are cautioned
not to place undue reliance upon any forward-looking statements in
this press release. Additional factors are discussed in the
Company's filings made or to be made with the SEC, which are
available for review at www.sec.gov. We undertake no obligation to
publicly revise these forward-looking statements to reflect events
or circumstances that arise after the date hereof unless required
by applicable laws, regulations, or rules.
Contacts
Coeptis Therapeutics, Inc.
IR@coeptistx.com
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SOURCE Coeptis Pharmaceuticals, Inc.
