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 quarter ended March 31, 2024.
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 2Q24 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 (FTD), with an IND planned in
2H24, and Parkinson’s disease (PD), with animal data 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
- Presented updated biomarker data in late April 2024 at the 2nd
Annual Johnson Center Symposium that showed 4-HNE levels were
predictive of survival in ALS patients and are elevated at
diagnosis in bulbar vs. limb onset ALS
“During the first quarter of 2024, we expanded our clinical
pipeline with our lead asset COYA 302 beyond the initial indication
of ALS and into FTD, Parkinson’s, and Alzheimer’s diseases,” stated
Howard Berman, Ph.D., Coya’s Chief Executive Officer. “Based on our
work to date, we believe the dual mechanism of action from COYA
302, a combination of our proprietary low-dose IL-2 and CTLA4-Ig,
holds immense potential in treating such neurodegenerative diseases
that have complex immune pathways. The combination effect of
restoring Tregs via low-dose IL-2 and inhibiting other inflammatory
cell types via CTLA4-Ig could be a significant breakthrough
therapeutic approach, much like the growing acceptance of
combination therapy in treating cancer or viral diseases. Many
patients, families, and caregivers are looking for meaningful new
therapies for these neurodegenerative diseases.
“We expect to report clinical progress from a number of
initiatives over the balance of 2024 with COYA 302, our ‘pipeline
in a product.’ In ALS, our lead indication, we expect to file the
IND for COYA 302 in 2Q24 and subsequently initiate the Ph. 2 trial.
Over the last two months, we have presented encouraging data in
patients with ALS that strongly correlates the biomarker 4-HNE with
the rate of progression and survival in patients with ALS. We are
in discussions with the FDA about the inclusion of 4-HNE in the
expected Ph. 2 trial. Additionally, clinical data from the
previously completed investigator-initiated trial in patients with
ALS is also anticipated in the second quarter.
“In Alzheimer’s disease, data from the Ph. 2
investigator-initiated trial involving COYA 301, or low-dose IL-2
alone, is expected in the summer of 2024. Given our previously
announced decision to move forward in Alzheimer’s with COYA 302,
data from this trial will help guide us in the subsequent trial
design of COYA 302 in AD. Obviously, Alzheimer’s disease is a huge
unmet need, so we eagerly anticipate results from the Ph. 2 trial
of COYA 301.
“In 2H24, we expect to file the IND in FTD and subsequently
initiate a Ph. 2 trial thereafter. Data shared in March 2024 at the
AD/PD 2024 Conference in Lisbon highlighted the reduction in Treg
suppressive function and the simultaneous elevated inflammatory
environment in patients with FTD. This data in FTD is consistent
with Treg dysfunction and increased inflammatory levels in other
progressive and neurodegenerative diseases and supports the
multi-pathway combination approach of COYA 302.
“The potential therapeutic applications with COYA 302 in
neurodegenerative diseases are vast. Dr. Reddy’s Laboratories was
granted an exclusive license in December 2023 for COYA 302 in ALS
patients in the U.S., Canada, the EU, and the U.K. We continue to
have discussions about additional commercial partnerships and
license opportunities for COYA 302 in other indications outside of
ALS, including FTD, Parkinson’s and Alzheimer’s diseases. Our cash
and cash equivalents balance of $36.0 million provides us a runway
into 2026, so we can be patient with any future commercial
negotiations in order to maximize shareholder value. I look forward
to sharing additional corporate, clinical, and regulatory progress
as warranted,” concluded Berman.
Unaudited Financial Results
As of March 31, 2024, Coya had cash and cash equivalents of
$36.0 million.
Research and development (R&D) expenses were $3.1 million
for the three months ended March 31, 2024, compared to $1.2 million
for the three months ended March 31, 2023. The change was primarily
due to a $1.7 million increase in our preclinical expenses and a
$0.2 million increase in internal research and development
expenses.
General and administrative expenses were $2.4 million for the
three months ended March 31, 2024 and $1.7 million for the three
months ended March 31, 2023, a change of approximately $0.7
million. The increase was primarily due to an increase in personnel
related expenses and consulting fees as we continue to expand our
operations to support our research and development efforts.
Net loss was $5.1 million for the three months ended March 31,
2024, compared to net loss of $2.7 million for the three months
ended March 31, 2023.
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.
CONDENSED BALANCE
SHEETS
March 31,
December 31,
2024
2023
(unaudited)
Assets
Current assets:
Cash and cash equivalents
$
35,989,406
$
32,626,768
Collaboration receivable
-
7,500,000
Prepaids and other current assets
1,344,955
1,069,557
Total current assets
37,334,361
41,196,325
Fixed assets, net
59,109
65,949
Total assets
$
37,393,470
$
41,262,274
Liabilities and Stockholders'
Equity
Current liabilities:
Accounts payable
$
1,587,943
$
1,155,656
Accrued expenses
2,041,530
2,973,215
Deferred collaboration revenue
689,669
923,109
Total current liabilities
4,319,142
5,051,980
Deferred collaboration revenue
681,287
574,685
Total liabilities
5,000,429
5,626,665
Stockholders' equity:
Series A convertible preferred stock,
$0.0001 par value: 10,000,000 shares authorized, none issued or
outstanding as of March 31, 2024 or December 31, 2023
-
-
Common stock, $0.0001 par value;
200,000,000 shares authorized; 14,613,172 and 14,405,325 shares
issued and outstanding as of March 31, 2024 and December 31, 2023,
respectively
1,462
1,441
Additional paid-in capital
63,449,125
61,501,801
Subscription receivable
(149,250
)
(11,250
)
Accumulated deficit
(30,908,296
)
(25,856,383
)
Total stockholders' equity
32,393,041
35,635,609
Total liabilities and stockholders'
equity
$
37,393,470
$
41,262,274
CONDENSED UNAUDITED INTERIM
STATEMENTS OF OPERATIONS
Three Months Ended March
31,
2024
2023
Collaboration revenue
$
126,838
$
-
Operating expenses:
Research and development
3,138,159
1,231,712
In-process research and development
25,000
-
General and administrative
2,439,841
1,661,544
Depreciation
6,840
6,840
Total operating expenses
5,609,840
2,900,096
Loss from operations
(5,483,002
)
(2,900,096
)
Other income:
Other income, net
431,089
163,634
Net loss
$
(5,051,913
)
$
(2,736,462
)
Per share information:
Net loss per share of common stock, basic
and diluted
$
(0.35
)
$
(0.28
)
Weighted-average shares of common stock
outstanding, basic and diluted
14,457,839
9,721,847
CONDENSED UNAUDITED INTERIM
STATEMENTS OF CASH FLOWS
Three Months Ended March
31,
2024
2023
Cash flows from operating
activities:
Net loss
$
(5,051,913
)
$
(2,736,462
)
Adjustment to reconcile net loss to net
cash used in operating activities:
Depreciation
6,840
6,840
Stock-based compensation, including the
issuance of restricted stock
435,663
180,387
Acquired in-process research and
development assets
25,000
-
Changes in operating assets and
liabilities:
Collaboration receivable
7,500,000
-
Prepaids and other current assets
(275,398
)
239,295
Accounts payable
477,265
(270,111
)
Accrued expenses
(844,745
)
(1,283,674
)
Deferred collaboration revenue
(126,838
)
-
Net cash provided by (used in) operating
activities
2,145,874
(3,863,725
)
Cash flows from investing
activities:
Purchase of in-process research and
development assets
(25,000
)
-
Net cash used in investing activities
(25,000
)
-
Cash flows from financing
activities:
Proceeds from issuance of common stock
upon initial public offering, net of offering costs
-
14,250,311
Proceeds from subscription receivable
11,250
-
Payment of financing costs related to the
2023 Private Placement
(131,918
)
-
Proceeds from the exercise of stock
options
1,975
-
Proceeds from the exercise of warrants
1,360,457
-
Net cash provided by financing
activities
1,241,764
14,250,311
Net increase in cash and cash
equivalents
3,362,638
10,386,586
Cash and cash equivalents as of beginning
of the period
32,626,768
5,933,702
Cash and cash equivalents as of end of the
period
$
35,989,406
$
16,320,288
Supplemental disclosures of non-cash
financing and investing activities:
Conversion of convertible preferred stock
upon initial public offering
$
-
$
8,793,637
Conversion of convertible promissory notes
upon initial public offering
$
-
$
12,965,480
Subscription receivable related to warrant
exercise
$
149,250
$
-
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240509929442/en/
Investor Contact David
Snyder david@coyatherapeutics.com CORE IR Bret Shapiro
brets@coreir.com 561-479-8566 Media
Contact Kati Waldenburg media@coyatherapeutics.com
212-655-0924
Grafico Azioni Coya Therapeutics (NASDAQ:COYA)
Storico
Da Mag 2024 a Giu 2024
Grafico Azioni Coya Therapeutics (NASDAQ:COYA)
Storico
Da Giu 2023 a Giu 2024