Coya Therapeutics, Inc. (Nasdaq: COYA) (“Coya” or the
“Company”), a clinical-stage biotechnology company developing
biologics intended to enhance regulatory T cell (Treg) function,
provides a corporate update and announces its financial results for
the year ended December 31, 2023.
2023 Corporate
Highlights
- Closed IPO in January 2023 for net proceeds of $14.1
million
- Reached agreement in March 2023 with Dr. Reddy’s Laboratories,
Ltd. (Dr. Reddy’s) to in-license an Abatacept (CTLA4-Ig) biosimilar
candidate for the development of COYA 302
- Presented positive results in March 2023 from a
proof-of-concept academic clinical study in patients with
Amyotrophic Lateral Sclerosis (ALS) demonstrating that patients
administered a combination of low dose interleukin-2 (LD IL-2) and
CTLA4-Ig exhibited no progression on the ALSFRS-R Rating Scale at
24 weeks and showed minimal decline at 48 weeks. COYA 302 is Coya’s
combination of its proprietary LD IL-2 formulation with the
immunomodulatory drug CTLA4-Ig.
- Presented positive results in May 2023 from an open-label,
proof-of-concept academic clinical study in patients with
Alzheimer’s disease (AD) that demonstrated LD IL-2 administration
resulted in a statistically significant improvement vs. baseline in
cognitive function after four mounts of treatment, as measured by
the Mini Mental Status Exam (MMSE) rating scale, and no decline vs.
baseline, as measured by the Clinical Dementia Rating Scale
(CDR-SB) and the Alzheimer’s Disease Assessment Scale Cognitive
Subscale (ADAS-Cog). COYA 301 is Coya’s proprietary LD IL-2
formulation.
- Investigator-initiated Ph. 2 study of LD IL-2 in patients with
AD completed in October 2023
- Entered into an exclusive collaboration for the development and
commercialization of COYA 302 with Dr. Reddy’s in December 2023 for
the treatment of ALS in U.S., Canada, the EU, and the U.K. – Coya
to receive up to $733 million in upfront and milestone payments
plus low-to-mid teens product royalties
- Successfully closed a private placement in December 2023 that
generated net proceeds of $24.0 million
- Strengthened the management team with appointments of Arun
Swaminathan, Ph.D. as Chief Business Officer in March 2023, Dr.
Michelle Frazier as Senior Vice President of Regulatory Affairs in
June 2023, and Dr. Fred Grossman as President and Chief Medical
Officer in July 2023
- Welcomed Dieter Weinand and Wilbur L. Ross, former U.S.
Secretary of Commerce, to the Board of Directors in August 2023 and
December 2023, respectively
Additional Recent Corporate
Highlights
- Announced successful pre-IND and Type C meetings with FDA in
January 2024 to advance the development of COYA 302 for the
treatment of ALS - IND expected to be filed in 1H 2024 followed by
initiation of Ph. 2 trial with COYA 302 in ALS
- Expanded pipeline of COYA 302 in January 2024 beyond ALS to
also include Frontotemporal Dementia (FD), with an IND planned in
2H24, and Parkinson’s disease (PD), with animal data in PD to be
released in 2H24
- Expanded patent estate surrounding next-generation immune
modulatory biologics in February 2024 through a license from the
University of Nebraska Medical Center to cover multiple LD IL-2
combinations, including those with Granulocyte-Macrophage Colony
Stimulating Factor (GM-CSF)
- Expanded pipeline of COYA 302 in February 2024 to include AD –
COYA 302 to now be explored in four neurodegenerative diseases
(ALS, PD, FTD, and AD) – Coya to leverage data from the Ph. 2 LD
IL-2 study in AD to inform on strategy and next steps for COYA 302
in AD
- Presented data in March 2024 on immune system and Regulatory T
Cell (Treg) contribution in Frontotemporal Dementia (FTD) patients
at the AD/PD 2024 Conference
- Presented novel biomarker data in March 2024 documenting serum
levels of a biomarker (4-HNE) that strongly correlate with rate of
progression and survival in patients with ALS at the Society of
Neuroimmune Pharmacology conference. Coya has filed intellectual
property on multiple uses of 4-HNE in ALS.
“We believe that we have under-promised and over-delivered in
executing on numerous deliverables in 2023 that have brought value
to Coya,” commented Howard Berman, Ph.D., Chief Executive Officer
of Coya. “The year began with the closing of our IPO and ended with
a pivotal commercialization deal with Dr. Reddy’s for our lead drug
candidate COYA 302 in ALS and an equity offering that together
provide a meaningful cash runway into 2026, along with significant
financial upside from additional future milestone payments and
royalties upon commercialization in ALS.
“Our clinical evidence to date, much of which was presented in
2023 in various forums and is the basis of our path forward with
COYA 302, points to combination biologics with our LD IL-2 as a
potential next-generation therapeutic approach to treat complex
immune pathways in neurodegenerative diseases. We see very similar
disease pathways in ALS, FTD, PD, and AD and believe the
restoration of regulatory T cells, or Tregs, while simultaneously
inhibiting other inflammatory cell types, may be a meaningful
approach to ultimately help millions of patients who suffer from
these debilitating diseases that have very few, if any, proven
treatment options. Similar to the historical treatment progression
seen in oncology and viral disease indications, combination therapy
may offer unique opportunities to treat complex, multi-pathway
diseases in the neurodegenerative world.
“The results from our proof-of-concept trial in ALS patients
demonstrated that LD IL-2 + CTLA4-Ig was able to essentially stop
the signs of disease progression at 24 weeks (as measured by the
ALSFRS-R Rating Scale) and meaningfully slow progression at 48
weeks in a population that normally deteriorates at a fairly steady
rate with each passing month. We anticipate filing the IND for COYA
302 in 2Q24 and subsequently initiating our Ph. 2 trial in ALS to
substantiate these initial findings. Topline data from this trial
is expected in 2025.
“We also expanded COYA 302 into PD, FTD, and AD, given our
research and clinical findings in a proof-of-concept trial that
showed LD IL-2 was able to improve cognitive function in AD
patients after four months of treatment. While this monotherapy
data is clearly intriguing, we believe that treating PD, FTD, and
AD patients with our combination therapy of COYA 302, our LD IL-2
and the immunomodulatory CTLA4-Ig, may offer an even better
approach in these patient populations, given what we believe are
similar underlying multiple, complex pathways. In fall of 2023, we
completed enrollment of a Ph. 2 investigator initiated trial
evaluating LD IL-2 in AD. The results from that trial, expected
during summer of 2024, are expected to serve as the basis for the
design of a future trial with COYA 302 in AD patients.
“Additionally, we anticipate filing an IND in the second half of
2024 to evaluate COYA 302 in patients with FTD and initiating that
trial shortly thereafter. Topline data from this Ph. 2 trial in FTD
is expected in 2025.
“Thus, one can see why we now refer to COYA 302 as a ‘Pipeline
in a Product.’ ALS is our lead indication, but many other larger
neurodegenerative patient populations also stand to benefit given
the common disease pathways involved. As we release additional
clinical data and biomarker data across these numerous
neurodegenerative diseases in 2024 and execute on the clinical
milestones I have mentioned, we hope it becomes clear why we
believe in our science and our clinical and regulatory pathways,"
concluded Berman.
Financial Results
As of December 31, 2023, Coya had cash and cash equivalents of
$32.6 million and received an additional $7.5 million in January
from Dr. Reddy’s as an upfront payment as part of the COYA 302
licensing arrangement.
Research and development (R&D) expenses were $5.5 million
for the year ended December 31, 2023, compared to $4.4 million for
the year ended December 31, 2022. The change was primarily due to a
$2.2 million increase in our preclinical expenses and a $0.5
million increase in internal research and development expenses,
partially offset by a $1.4 million decrease in costs attributable
to our sponsored research agreement with Houston Methodist Hospital
and a $0.3 million decrease in costs for our clinical product
candidate.
General and administrative expenses were $7.8 million for the
year ended December 31, 2023, and $4.8 million for the year ended
December 31, 2022, a change of approximately $3.0 million. The
increase was primarily due to an increase in personnel related
expenses arising from increases in employee headcount and an
increase in our professional fees and consulting fees as we
expanded our operations to support our research and development
efforts.
Net loss was $8.0 million for the year ended December 31, 2023,
compared to net loss of $12.2 million for the year ended December
31, 2022.
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 as a result of new information, future developments
or otherwise.
BALANCE SHEETS
(Audited)
December 31,
2023
2022
Assets
Current assets:
Cash and cash equivalents
$
32,626,768
$
5,933,702
Collaboration receivable
7,500,000
-
Prepaids and other current assets
1,069,557
1,251,264
Total current assets
41,196,325
7,184,966
Fixed assets, net
65,949
93,310
Deferred financing costs
-
1,117,290
Total assets
$
41,262,274
$
8,395,566
Liabilities and Stockholders' Equity
(Deficit)
Current liabilities:
Accounts payable
$
1,155,656
$
1,815,270
Accrued expenses
2,973,215
2,008,361
Deferred collaboration revenue
923,109
-
Total current liabilities
5,051,980
3,823,631
Deferred collaboration revenue
574,685
-
Convertible promissory notes
-
12,965,480
Total liabilities
5,626,665
16,789,111
Commitments and contingencies (Note 7)
Stockholders' equity (deficit):
Series A convertible preferred stock,
$0.0001 par value: 10,000,000 shares authorized, none and 7,500,713
issued and outstanding as of December 31, 2023 and December 31,
2022, respectively
-
8,793,637
Common stock, $0.0001 par value;
200,000,000 shares authorized; 14,405,325 and 2,590,197 shares
issued and outstanding as of December 31, 2023 and December 31,
2022, respectively
1,441
259
Additional paid-in capital
61,501,801
681,106
Subscription receivable
(11,250
)
-
Accumulated deficit
(25,856,383
)
(17,868,547
)
Total stockholders' equity (deficit)
35,635,609
(8,393,545
)
Total liabilities and stockholders' equity
(deficit)
$
41,262,274
$
8,395,566
STATEMENTS OF
OPERATIONS
(Audited)
Years Ended December
31,
2023
2022
Collaboration revenue
$
6,002,206
$
-
Operating expenses:
Research and development
5,501,527
4,412,498
In-process research and development
543,186
525,000
General and administrative
7,833,481
4,847,080
Depreciation
27,361
27,361
Total operating expenses
13,905,555
9,811,939
Loss from operations
(7,903,349
)
(9,811,939
)
Other income:
Change in fair value of convertible
promissory notes
-
(2,496,510
)
Other income, net
639,365
63,673
Pre-tax loss
(7,263,984
)
(12,244,776
)
Income tax expense
(723,852
)
-
Net loss
$
(7,987,836
)
$
(12,244,776
)
Share information:
Net loss per share of common stock, basic
and diluted
$
(0.79
)
$
(4.73
)
Weighted-average shares of common stock
outstanding, basic and diluted
10,163,850
2,590,173
STATEMENTS OF CASH
FLOWS
(Audited)
Years Ended December
31,
2023
2022
Cash flows from operating
activities:
Net loss
$
(7,987,836
)
$
(12,244,776
)
Adjustment to reconcile net loss to net
cash used in operating activities:
Depreciation
27,361
27,361
Change in fair value of convertible
promissory notes
-
2,496,510
Stock-based compensation, including the
issuance of restricted stock
872,248
207,346
Debt issuance costs
-
997,367
Acquired in-process research and
development assets
543,186
525,000
Changes in operating assets and
liabilities:
Collaboration receivable
(7,500,000
)
-
Prepaids and other current assets
181,707
(920,002
)
Accounts payable
298,816
845,284
Accrued expenses
877,913
826,556
Deferred collaboration revenue
1,497,794
-
Net cash used in operating activities
(11,188,811
)
(7,239,354
)
Cash flows from investing
activities:
Purchase of in-process research and
development assets
(543,186
)
(525,000
)
Net cash used in investing activities
(543,186
)
(525,000
)
Cash flows from financing
activities:
Proceed from sale of common stock from
2023 Private Placement, net of offering costs
24,084,805
-
Proceeds from issuance of common stock
upon IPO, net of offering costs
14,250,311
-
Payment of deferred financing costs
related to the IPO
-
(113,883
)
Proceeds from the issuance of convertible
promissory notes
-
10,468,970
Payment of debt issuance costs
-
(997,367
)
Proceeds from the exercise of stock
options
89,947
158
Net cash provided by financing
activities
38,425,063
9,357,878
Net increase in cash and cash
equivalents
26,693,066
1,593,524
Cash and cash equivalents as of beginning
of the year
5,933,702
4,340,178
Cash and cash equivalents as of end of the
year
$
32,626,768
$
5,933,702
Supplemental disclosures of non-cash
financing activities:
Conversion of convertible preferred stock
upon IPO
$
8,793,637
$
-
Conversion of convertible promissory notes
upon IPO
$
12,965,480
$
-
Subscription receivable related to warrant
exercise
$
11,250
$
-
Financing costs related to the 2023
Private Placement in accrued expenses
$
86,940
$
-
Financing costs related to the 2023
Private Placement in accounts payable
$
44,978
$
-
Deferred financing costs related to the
IPO in accrued expenses
$
-
$
1,003,408
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version on businesswire.com: https://www.businesswire.com/news/home/20240319867067/en/
Investor Contact David Snyder
david@coyatherapeutics.com
CORE IR Bret Shapiro brets@coreir.com 561-479-8566
Media Contact Jessica Starman
media@coyatherapeutics.com
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