Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the
“Company”), a clinical-stage biotechnology company developing
biologics intended to enhance Treg function, today released the
following letter to stockholders from its Chief Executive Officer
and Chairman, Dr. Howard Berman.
Dear Fellow Stockholders,
As the year comes to a close, I want to take a moment to reflect
on Coya’s accomplishments and share our strategic vision for the
coming year. We set ambitious goals at the beginning of 2023 and I
am pleased to say that our team rose to the occasion. Throughout
the year, we notched several “wins,” culminating in a
transformative licensing transaction, announced December 6th, 2023,
with Dr. Reddy’s Laboratories (DRL). This partnership for COYA 302
in Amyotrophic Lateral Sclerosis (ALS) provides up to $733 MM in
non-dilutive upfront payments and potential sales and regulatory
milestones ($677.25 MM in sales based milestones and net sales; $40
MM of development and regulatory milestones; $7.5 MM upfront
payment, and $8.4 MM in aggregate milestone payments upon IND
filing and first patient first dosed). Coya also successfully
closed a private placement financing of $26.5 MM in gross proceeds,
at a time when capital raising for biotech has been limited. We
anticipate that the cumulative proceeds from these two transactions
will finance us into 2026.
Why us? Because our C-suite team has “innovation DNA” ⏤ we think
out of the box, we’re creative and we strive to execute rapidly.
Our 2023 successes leave us wanting more. We plan to advance our
pipeline and drive new partnerships with the goal of bringing much
needed therapies to people in need. We expect to build on our
momentum in 2024 with disciplined execution on our strategic
goals.
I want to begin by extending my ongoing thanks to all of our
investors for the confidence they have placed in our company. The
year began with the closing of our IPO on January 3rd, 2023 and it
has ended with the closing of a private placement on December 11th,
2023, where we raised gross proceeds of $26.5 million. We were
delighted that the private placement reflected additional
investment by existing investors. But we’re equally grateful to the
new investors who have joined us, including Wilbur Ross, the former
United States Secretary of Commerce. We understand and appreciate
our obligations to remain careful stewards of this new capital.
Cash Runway into 2026. One of our key objectives
for 2023 was to raise additional capital through business
development or partnering transactions. This goal was successfully
achieved on December 6th, 2023 when we announced a significant
partnership with DRL for the development and commercialization of
COYA 302 (our proprietary low dose IL-2 and CTLA-4 Ig). This
partnership is important both financially and strategically.
Financially, the cash proceeds from this partnership, combined with
the proceeds from our private placement, is anticipated to provide
a cash runway which extends into 2026. Consequently, we believe it
will also provide sufficient cash resources to complete the Phase 2
trial of COYA 302 while retaining long-term financial growth from
this asset in ALS. Proceeds to us from the partnership with DRL
include a $7.5 MM upfront payment, $8.4 MM in aggregate milestone
payments upon IND filing (anticipated in 2024) and first patient
first dose of COYA 302 in a Phase 2 trial, $40 MM of development
and regulatory milestones, $677.25 MM of sales-based milestones and
net sales royalties from the low to middle teens.
Strategic Partnering and New Business Development.
We view the partnership with DRL as a “beachhead deal,” a first
proof-of-concept successful transaction focusing on only one
indication, in this case ALS, leaving other indications available
for our licensing and/or sole development. We believe that based on
its unique multi-modal mechanism of action, COYA 302 may have
therapeutic applications beyond ALS, in multiple therapeutic areas
and as a result provide a platform for ongoing partnering activity
across disease conditions (see below).
As such, we will leverage the momentum created by the DRL
partnership to drive execution of new transactions related to COYA
302 with an intention to: (a) broaden its application in novel
indications, (b) infuse additional non-dilutive financing into the
company, and (c) expand our product candidate pipeline.
Clinical Development. We expect to file an IND for COYA
302 and upon acceptance, initiate the clinical trial. We are
hopeful to see top-line results from this trial in late 2025.
Second, we are waiting for results in an ongoing Phase 2,
double-blind, randomized trial (funded by the Gates Foundation and
the Alzheimer’s Association) for use of low dose IL-2 in mild to
moderate Alzheimer’s Disease (AD) patients. The trial is fully
enrolled at Houston Methodist and we anticipate reporting top line
data in the summer of 2024. We believe these data will provide
important guidance for our development of COYA 301 (low dose IL-2)
or COYA 302 in Alzheimer’s Disease. We also believe that
combination immunotherapies such as COYA 302 may have mechanistic
advantages over monotherapy approaches in reducing inflammation and
oxidative stress in inflammatory related neurodegenerative and
autoimmune conditions, which is an ongoing area of our research and
development.
Our scientific and clinical work throughout 2023 suggest that
COYA 302 may have application in multiple therapeutic areas based
on its unique multi-modal mechanism of action. Neurodegenerative
and autoimmune conditions are driven by dysfunctional regulatory T
cells (Tregs) combined with a hyperactive innate immune response
and it is precisely these mechanisms that COYA 302 targets. In the
coming year, we hope to demonstrate the applicability of COYA 302
to other disease conditions, and should we successfully do so, we
believe we can create opportunities for both pipeline expansion and
additional strategic business development partnerships.
Pursuing Creative Strategic Trial Collaborations. We
believe that combination immunotherapies which target multiple
immune pathways are of particular and growing relevance to
translational research in neurodegenerative diseases. We believe
the emergence of neuroscience as a core area of non-profit drug
discovery foundations expands potential funding opportunities and
strategic partnerships to conduct focused trials in additional
neurodegenerative diseases for COYA 302. One of our aims in 2024 is
to pursue collaborations with clinical trial and drug discovery
neuroscience focused funding foundations that share a common
mission and vision for COYA 302 in different neurologic
conditions.
Well Positioned for Growth. We enter 2024 with
significantly expanded financial resources and we believe there is
growing evidence that our Treg focused therapeutics may show
application in a variety of unmet medical needs and the clinical
data we reported for COYA 302 and 301 support additional disease
indications for pipeline expansion. Beginning with our IPO early in
2023, followed by encouraging clinical data, and the execution of a
promising partnership and private placement financing, I believe we
have executed a major transformation of our company. We’re excited
for you to join us for more throughout 2024!
About Coya Therapeutics, Inc.
Headquartered in Houston, TX, Coya Therapeutics, Inc. (Nasdaq:
COYA) is a clinical-stage biotechnology company developing
proprietary treatments focused on the biology and potential
therapeutic advantages of regulatory T cells (“Tregs”) to target
systemic inflammation and neuroinflammation. Dysfunctional Tregs
underlie numerous conditions including neurodegenerative,
metabolic, and autoimmune diseases, and this cellular dysfunction
may lead to a sustained inflammation and oxidative stress resulting
in lack of homeostasis of the immune system. For more information
about Coya, please visit www.coyatherapeutics.com.
Forward-Looking Statements
This release contains “forward-looking statements” made pursuant
to the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995. These statements are typically preceded by
words such as “may,” “can,” “anticipate,” “assume,” “should,”
“indicate,” “would,” “believe,” “contemplate,” “expect,” “seek,”
“estimate,” “continue,” “plan,” “point to,” “project,” “predict,”
“could,” “intend,” “target,” “potential,” “will,” or similar words
and expressions of the future. Forward-looking statements include
all statements other than statements of historical fact contained
in this presentation, including information concerning our current
and future financial performance, business plans and objectives,
current and future clinical and preclinical development activities,
timing and success of our ongoing and planned clinical trials and
related data, the timing of announcements, updates and results of
our clinical trials and related data, our ability to obtain and
maintain regulatory approval, the potential therapeutic benefits
and economic value of our product candidates, competitive position,
industry environment and potential market opportunities. These
forward-looking statements reflect management’s current knowledge,
assumptions, judgment and expectations regarding future performance
or events. Although management believes that the expectations
reflected in such statements are reasonable, they give no assurance
that such expectations will prove to be correct or that those goals
will be achieved, and you should be aware that actual results could
differ materially from those contained in the forward-looking
statements. Forward-looking statements are subject to a number of
risks and uncertainties, including, but not limited to, the
success, cost and timing of our product candidate development
activities and ongoing and planned clinical trials; our plans to
develop and commercialize targeted therapeutics; the progress of
patient enrollment and dosing in our preclinical or clinical
trials; the ability of our product candidates to achieve applicable
endpoints in the clinical trials; the safety profile of our product
candidates; the potential for data from our clinical trials to
support a marketing application, as well as the timing of these
events; our ability to obtain funding for our operations;
development and commercialization of our product candidates; the
timing of and our ability to obtain and maintain regulatory
approvals; the rate and degree of market acceptance and clinical
utility of our product candidates; the size and growth potential of
the markets for our product candidates, and our ability to serve
those markets; our commercialization, marketing and manufacturing
capabilities and strategy; future agreements with third parties in
connection with the commercialization of our product candidates;
our expectations regarding our ability to obtain and maintain
intellectual property protection; our dependence on third party
manufacturers; the success of competing therapies or products that
are or may become available; our ability to attract and retain key
scientific or management personnel; our ability to identify
additional product candidates with significant commercial potential
consistent with our commercial objectives; and our estimates
regarding expenses, future revenue, capital requirements and needs
for additional financing. For a further description of the risks
and uncertainties that could cause actual results to differ from
those expressed in these forward-looking statements, as well as
risks relating to the Company’s business in general, please refer
to the Company’s Form 10-K for the year ended December 31, 2022 and
Forms 10-Q for the quarters ended March 31, 2023, June 30, 2023 and
September 30, 2023.
All forward-looking statements are expressly qualified in their
entirety by this cautionary notice. You are cautioned not to place
undue reliance on any forward-looking statements, which speak only
as of the date of this release. We have no obligation, and
expressly disclaim any obligation, to update, revise or correct any
of the forward-looking statements, whether as a result of new
information, future events or otherwise.
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version on businesswire.com: https://www.businesswire.com/news/home/20231213895090/en/
Investor Contact David Snyder david@coyatherapeutics.com
Hayden IR James Carbonara (646)-755-7412 James@haydenir.com
Media Contact media@coyatherapeutics.com
Coya Therapeutics (NASDAQ:COYA)
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Coya Therapeutics (NASDAQ:COYA)
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