Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the
“Company”), a clinical-stage biotechnology company developing
biologics intended to enhance Treg function, releases the following
letter to stockholders from Chief Executive Officer Dr. Arun
Swaminathan.
Dear Fellow Stockholder,
Given my recent transition to the role of CEO, I wanted to share
my thoughts on Coya and our future and to express my gratitude to
our founder and Executive Chair, Dr. Howard Berman, whose bold
vision has instilled the “innovation and get-it-done” culture in
Coya’s DNA. We have made tremendous strides in 2024, repeatedly
executing on our promises. As I look to 2025, I am confident that
our nimble and highly experienced team will continue to exceed
expectations.
I have spent my entire 25-year career in the biotech space, and
I believe that Coya has the most promise of any company that I have
represented. I truly believe our novel science, strong clinical
proof of concept data, pharmaceutical partnership validation, cash
runway, and clear path to a commercial drug differentiates us.
Prior to serving at Coya, I helped spearhead and lead
pharmaceutical transactions worth billions of dollars that led to
significant value creation. I believe the opportunities ahead of us
in 2025 and beyond are what investors, stockholders, and patients
should be most excited about. Our science and approach of
regulating Tregs is now validated in multiple trials across
multiple neurodegenerative diseases, we have a track record of
executing value-creating non-dilutive deals, and our strong cash
position allows us to be prudent in our decisions.
Year Ahead
We expect our activities in 2025 to be focused on the following
indications:
ALS (Amyotrophic Lateral Sclerosis) Program: We have
alignment with the FDA on the data required to initiate our
potentially pivotal COYA 302 Phase 2 double-blind randomized study
in patients with ALS. We are targeting the submission of the
requested data package by 2Q 2025 and initiation of the clinical
trial upon FDA clearance. The roadmap to topline results is now
clear with reduced uncertainty. In late 2023, we partnered with Dr.
Reddy’s Laboratories, a multi-billion-dollar drug developer, to
license COYA 302 in ALS in a deal that is worth up to $700 million.
We still retain the rights to COYA 302 in ALS in Japan and
South/Central America and Mexico, thus providing us direct upside
and optionality in this indication alone.
FTD (Frontotemporal Dementia) Program: We expect to see
topline results in 2H 2025 from the investigator-initiated,
open-label study of Low Dose IL-2 (LD IL-2) + CTLA4-Ig in FTD.
Study endpoints will measure safety, peripheral and central
inflammation, FTD progression, and pharmacodynamic effects on Treg
cell populations. The data are expected to guide our planned COYA
302 Phase 2 double-blind randomized study (which will be funded by
the Alzheimer’s Drug Discovery Foundation) and further optimize the
design for success. The guidance from the FDA on the ALS IND
reduces uncertainty on the planned IND filing for FTD in 2H of
2025. We have retained full commercial rights on this program thus
far, providing us optionality to develop the program to BLA
approval ourselves and capture the full potential upside or partner
at a later stage once we obtain additional clinical data.
AD (Alzheimer’s disease) Program: Complementing the
promising data that was presented at CTAD in Madrid for LD IL-2 in
mild to moderate AD, the investigators will disclose additional
data in 1H 2025 that summarizes the changes in inflammation in the
peripheral system (blood) and central nervous system (CSF and
brain) and other molecular measurements for the two IL-2 dosing
arms vs. placebo. These important data will help to further address
the basic science associated with the promising clinical response
observed in the lower dose IL-2 arm and its association with better
Treg enhancement. We retain full rights to the AD indication for
COYA 302 and are already in the process of exploring non-dilutive
and strategic partnering opportunities. While the CTAD data was
based on LD IL-2 alone and proved highly promising in and of
itself, COYA 302, which is a proprietary combination of LD IL-2 and
CTLA4-Ig, targets multiple pathways and is developed to more
significantly and durably enhance Treg function, which we believe
will be highly attractive to potential partners.
Strategic Partnerships
Dr. Reddy’s Partnership: Our partnership with Dr. Reddy’s
Laboratories is approaching its one-year anniversary, and our
collaboration could not be stronger. We have a reliable partner for
ALS, and leveraging its resources and expertise has created value
beyond the milestone payments. In 2025, we anticipate receiving
$8.4 million upon initiation of the Phase 2 ALS clinical trial and
will continue to evaluate opportunities to further deepen the
relationship.
Other Strategic Possibilities: As I have described, my
background is one of deal-making, and I intend to leverage my
network and capabilities to maximize opportunities for Coya in
2025. We have only partnered COYA 302 in ALS, and the optionality
to partner, co-develop, or license the asset in other indications
exists. Any potential transaction will be evaluated based on
maximizing stockholder value. The positive data from the
investigator-initiated trial of LD IL-2 in patients with
Alzheimer’s disease increases our confidence in obtaining
value-creating pharma partnerships that combine our proprietary LD
IL-2, COYA 301, with other modalities. I can envision multiple
opportunities with LD IL-2 serving as a backbone adjuvant with
standard of care agents and other novel pathways.
Moreover, the opportunity for grant funding and financial
support from foundations exists and will be vigorously pursued. We
believe the data emerging on Tregs in autoimmune disease (such as
lupus, rheumatoid arthritis, and scleroderma) and, in particular,
treatment with LD IL-2 is compelling and may strengthen the role of
COYA 302 and LD IL-2 combinations in this space. I intend to
actively pursue partnerships in this arena that would further place
us in a strong position to pursue value-creating deals.
Value-Creating Pipeline
Like many experts in the scientific community, we believe
combination strategies are the future to address devastating
neurodegenerative diseases. We believe targeting one mechanism or
pathway is likely insufficient to achieve maximal effect - hence
our approach with COYA 302. COYA 302 is a “Pipeline within a
Product” and has strong potential in ALS, FTD, AD, Parkinson’s
disease, and other indications.
We are continuously building our intellectual property to
further enhance the value of Coya. One recent development is the
combination of COYA 301 and GLP-1 agonists. Data suggests that the
mechanism of action appears additive and/or synergistic in
ameliorating inflammation. This is yet another opportunity for
value-creating strategic partnerships. We intend to publish more
detailed data in 1Q 2025.
Conclusion
As you can see from our past performance, our entire management
team is committed to the success of Coya. We expect to recognize a
number of clinical, regulatory, and/or commercial milestones in
2025 that will help us advance the treatment of neurodegenerative
diseases.
On behalf of the entire Coya team, please accept our sincere
gratitude for both your support and belief in our science, our
story, and our team. We look forward to presenting additional
clinical data and updating you on our additional corporate
developments as they unfold. Onwards and upwards!
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 sustained inflammation and oxidative stress resulting
in lack of homeostasis of the immune system.
Coya’s investigational product candidate pipeline leverages
multiple therapeutic modalities aimed at restoring the
anti-inflammatory and immunomodulatory functions of Tregs. Coya’s
therapeutic platforms include Treg-enhancing biologics,
Treg-derived exosomes, and autologous Treg cell therapy.
COYA 302 – the Company’s lead biologic investigational product
or "Pipeline in a Product" – is a proprietary combination of COYA
301 (Coya’s proprietary LD IL-2) and CTLA4-Ig for subcutaneous
administration with a unique dual mechanism of action that is now
being developed for the treatment of Amyotrophic Lateral Sclerosis,
Frontotemporal Dementia, Parkinson’s Disease, and Alzheimer’s
Disease. Its multi-targeted approach enhances the number and
anti-inflammatory function of Tregs and simultaneously lowers the
expression of activated microglia and the secretion of
pro-inflammatory mediators. This synergistic mechanism may lead to
the re-establishment of immune balance and amelioration of
inflammation in a sustained and durable manner that may not be
achieved by either low-dose IL-2 or CTLA4-Ig alone.
For more information about Coya, please visit
www.coyatherapeutics.com.
Forward-Looking Statements
This press release contains “forward-looking” statements that
are based on our management’s beliefs and assumptions and on
information currently available to management. 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. The words “believe,” “may,”
“will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,”
and similar expressions are intended to identify forward-looking
statements.
Forward-looking statements are subject to known and unknown
risks, uncertainties, assumptions and other factors including, but
not limited to, those related to risks associated with the impact
of COVID-19; 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.
We have based these forward-looking statements largely on our
current expectations and projections about future events and trends
that we believe may affect our financial condition, results of
operations, business strategy, short-term and long-term business
operations and objectives, and financial needs. Moreover, we
operate in a very competitive and rapidly changing environment, and
new risks may emerge from time to time. It is not possible for our
management to predict all risks, nor can we assess the impact of
all factors on our business or the extent to which any factor, or
combination of factors, may cause actual results to differ
materially from those contained in any forward-looking statements
we may make. In light of these risks, uncertainties and
assumptions, the forward-looking events and circumstances discussed
herein may not occur and actual results could differ materially and
adversely from those anticipated or implied in the forward-looking
statements. Although our management believes that the expectations
reflected in our forward-looking statements are reasonable, we
cannot guarantee that the future results, levels of activity,
performance or events and circumstances described in the
forward-looking statements will be achieved or will occur. We
undertake no obligation to publicly update any forward-looking
statements, whether written or oral, that may be made from time to
time, whether because of new information, future developments or
otherwise.
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version on businesswire.com: https://www.businesswire.com/news/home/20241119164131/en/
Investor Contact David
Snyder, CFO david@coyatherapeutics.com
CORE IR Bret Shapiro
brets@coreir.com 561-479-8566 Media
Contact For Coya Therapeutics: Kati Waldenburg
media@coyatherapeutics.com 212-655-0924
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