Coya Therapeutics, Inc. (Nasdaq: COYA) (“Coya” or the
“Company”), a clinical-stage biotechnology company developing
biologics and cell therapies intended to enhance the function of
Regulatory T Cells (Tregs), today announced its financial results
for the third quarter ended September 30, 2023, and provided a
clinical and business update.
Q3 2023 and Recent Highlights
- Completed enrollment in a randomized, double-blind,
placebo-controlled Phase 2 study of Low Dose IL-2 in patients with
mild-to-moderate Alzheimer’s Disease (AD).
- The study is being conducted by Drs. Stanley Appel and Alireza
Faridar at the Houston Methodist Hospital and is funded by the
Gates Foundation and Alzheimer’s Association.
- A total of 38 patients have been randomly assigned to receive
subcutaneous Low Dose IL-2 (LD IL-2) at two different dosing
regimens, or matching placebo, over 21 weeks. The first patient
cohort was randomized to receive LD IL-2 for 5 consecutive days
every 4 weeks and the second cohort was randomized to receive LD
IL-2 for 5 consecutive days every 2 weeks.
- This phase 2 well-controlled study is evaluating the safety and
tolerability, biological activity, blood and cerebrospinal fluid
biomarkers, neuroimaging, and changes in cognitive function of LD
IL-2 compared to placebo at pre-specified timepoints over the
course of the 21-week treatment period and at 9 weeks after the
last dose of study treatment.
- Topline results of the study are anticipated to be reported
Summer 2024.
- Reported new data supporting the mechanism of action of COYA
302 for the treatment of Amyotrophic Lateral Sclerosis (ALS) at the
22nd Annual Northeast ALS (NEALS) Consortium Meeting on October
4th, 2023.
- Details of the study can be found here. Results
of this study further support the mechanism of action and potential
of COYA 302 (LD IL-2 and CTLA4-Ig) to address the multiple immune
pathways involved in the progression and severity of ALS.
- Coya is working expeditiously in the planning and execution of
its next clinical study to evaluate the efficacy and safety of COYA
302 in patients with ALS.
- Secured the exclusive worldwide licensing rights of a
proprietary Exosome Engineering Technology (EET) from Carnegie
Mellon University (CMU)
- Applications across multiple indications, including
neurodegeneration, autoimmune, and oncology.
- This proprietary EET platform extends Coya’s pipeline beyond
Neurodegenerative disorders to include autoimmune disorders and
cancer while expanding Coya’s optionality for potential
non-dilutive business development and strategic partnerships with
companies seeking ways to deliver cargo/drugs in a targeted
fashion.
- Announced that Dr. Phil Campbell, Professor of Biomedical
Engineering at CMU, presented a proof-of-concept application of the
licensed exosome engineering technology, “Rapid Functionalization
of Treg Exosomes for Targeted Immunotherapy” at the 5th Exosome
Based Therapeutic Development Summit in Boston, MA
- The presentation can be accessed here.
- Coya and CMU entered into a Research Collaboration Agreement
and Option Agreement in 2022 to develop a unique patented
technology intended to advance the potential use of exosomes for
the treatment of diseases of unmet need.
- This proprietary technology expands Coya’s pipeline to include
autoimmune disorders and cancer. These engineered exosomes are
considered a cell-free drug delivery systems without genetic
modification that can travel throughout the body unimpeded,
including through the blood brain barrier, to provide specific
targeted therapies.
- Published a research article entitled “Immunological,
Oxidative, and Structural Factors and Their Responses to Regulatory
T Lymphocyte Therapy in Amyotrophic Lateral Sclerosis” in the
peer-reviewed journal Ageing and Neurodegenerative Diseases.
- The publication can be accessed here.
- Following these encouraging results, Coya plans to assess blood
markers of oxidative stress and inflammation systematically and
prospectively in the upcoming well powered placebo controlled
clinical study of COYA 302 in patients with ALS.
- Published additional AD clinical data for ld-IL-2 at the
Alzheimer’s Association International Conference (AAIC).
- Showed a significant decrease in biomarker levels known to be
associated with neuroinflammation in AD patients, further
supporting the initial positive results of the study.
- Blood levels of CCL4 (CC motif chemokine ligand 4), FLT3LG
(FMS-related tyrosine kinase 3 ligand) and TNFα (tumor necrosis
factor alpha) were consistently lower following administration of
ld IL-2.
- Announced that Dr. Alireza Faridar, Assistant Professor of
Neurology at Houston Methodist and Weill Cornell Medical College,
will give an oral presentation at the 18th International Conference
on Alzheimer’s and Parkinson’s Disease held in Lisbon, Portugal
between March 5-9, 2024.
- Details and Registration for the conference are found
here.
- Appointed Mr. Dieter Weinand, former Chairman and CEO at
Bayer Pharma AG, to its board of directors in August 2023.
- Coya will continue to leverage Mr. Weinand’s extensive
experience, connections, and judgement to guide Coya’s strategic
discussions and development programs. Dieter Weinand is an
experienced executive with over 25 years of experience in the
pharmaceuticals and biotech industries.
- Engaged Merit Cudkowicz, MD, MSc as expert clinical
advisor.
- Dr. Cudkowicz is a world-renowned neurologist who has dedicated
her career to improving the life of patients with ALS and other
serious neurological conditions. Dr. Cudkowicz brings decades of
experience supporting the development of new therapies for
ALS.
- Appointed Dr. Fred Grossman to its senior management team as
President and Chief Medical Officer in July 2023.
- Prior to joining Coya, Dr. Grossman held executive positions at
Eli Lilly, Johnson & Johnson, Bristol Myers Squibb, and
Sunovion. Dr. Grossman will leverage his over two decades of
clinical development expertise to guide and oversee all of Coya’s
development programs, including its lead asset, COYA 302, for the
treatment of ALS.
Howard Berman, Ph.D., Chief Executive Officer of Coya,
commented, “During Q3 and year-to-date, we believe Coya has
illustrated substantial value demonstrating a commitment to
execution and performance.
Coya’s core pipeline is centered around its immunomodulatory
biologic drugs, COYA 301 and COYA 302, intended to enhance Treg
function and numbers while suppressing other pro-inflammatory
pathways. We believe that targeting these critical pathways, both
individually and in combination, may provide for an exponential
shift in the treatment landscape of neurodegenerative diseases.
Focusing our efforts in ALS and AD is warranted given the promising
clinical signals that we have observed to date in proof of concept
clinical studies. Moreover, running the company efficiently with a
careful fiduciary eye to cost containment while delivering
significant value to shareholders and patients has been and will
continue to be the center of my approach.
We are aiming for a busy end to 2023 and productive 2024 with
numerous anticipated catalysts and milestones driving the value of
the business. Of importance, we plan to release top-line
double-blind, placebo-controlled Phase 2 data of LD IL-2 in AD,
expected by summer 2024. We also intend to submit an IND
application for a randomized double-blind placebo-controlled Phase
2 trial in ALS in 1H 2024. Further, we anticipate publishing
multiple peer reviewed publications during this time related to
blood biomarker findings in the prior LD IL-2/CTLA4Ig proof of
concept clinical trial, as well as clinical data findings for LD
IL-2 in AD,” concluded Dr. Berman.
Anticipated Events and Milestones
COYA 302 (ld IL-2 + CTLA4 Ig)
- Phase 2 IND Filing in ALS (1H 2024)
- Initiate Phase 2 trial in ALS (following IND Filing)
- Proof of Concept Phase 1 investigator-initiated clinical study
publication (Q1 2024)
- Biomarker data and ALS registry publication (Q1 2024)
COYA 301 (ld IL-2)
- Topline data of academic investigator Initiated Phase 2 double
blind trial in Alzheimer’s Disease (Summer 2024)
- Proof of Concept investigator-initiated Phase 1 clinical study
publication in Alzheimer’s Disease (Q4 2023 or Q1 2024)
- Phase 1 proof of concept investigator-initiated clinical study
in Alzheimer’s Disease presentation at 18th annual Alzheimer’s and
Parkinson’s Disease Conference (Q1 2024)
- Combination LD IL-2 + Undisclosed Drug AD animal data release
(2H 2024)
Financial Results (Unaudited)
As of September 30, 2023, Coya had cash and cash equivalents of
approximately $10.9 million.
Research and development (R&D) expenses were $1.6 million
for the quarter ended September 30, 2023, compared to $1.3 million
for the quarter ended September 30, 2022. The Company believes that
R&D spending in 2023 will increase over 2022 spending levels
and will be focused primarily on advancing COYA 302.
General and administrative expenses were $2.0 million for the
quarter ended September 30, 2023, and $1.2 million for the quarter
ended September 30, 2022, a change of approximately $0.8 million.
The change was primarily due to additional costs associated with
being a public company including investor and public relations,
director and officer insurance, financial advisory and compliance,
as well as an increased headcount. The Company expects general and
administrative costs to continue to grow in 2023 as Coya expands
its business development activities as well as incur additional
public company costs.
Net loss was $3.4 million for the quarter ended September 30,
2023, compared to net loss of $4.0 million for the quarter ended
September 30, 2022.
CONDENSED BALANCE
SHEETS
September 30,
December 31,
2023
2022
(unaudited)
Assets
Current assets:
Cash and cash equivalents
$
10,886,282
$
5,933,702
Prepaids and other current assets
936,354
1,251,264
Total current assets
11,822,636
7,184,966
Fixed assets, net
72,790
93,310
Deferred financing costs
-
1,117,290
Total assets
$
11,895,426
$
8,395,566
Liabilities and Stockholders' Equity
(Deficit)
Current liabilities:
Accounts payable
$
633,951
$
1,815,270
Accrued expenses
1,172,674
2,008,361
Total current liabilities
1,806,625
3,823,631
Convertible promissory notes
-
12,965,480
Total liabilities
1,806,625
16,789,111
Commitments and contingencies (Note 5)
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 September 30, 2023 and December 31,
2022, respectively
-
8,793,637
Common stock, $0.0001 par value;
200,000,000 shares authorized; 9,947,915 and 2,590,197 shares
issued and outstanding as of September 30, 2023 and December 31,
2022, respectively
996
259
Additional paid-in capital
37,210,163
681,106
Accumulated deficit
(27,122,358
)
(17,868,547
)
Total stockholders' equity (deficit)
10,088,801
(8,393,545
)
Total liabilities and stockholders' equity
(deficit)
$
11,895,426
$
8,395,566
CONDENSED UNAUDITED INTERIM
STATEMENTS OF OPERATIONS
Three Months Ended September
30,
2023
2022
Operating expenses:
Research and development
$
1,592,232
$
1,278,289
In-process research and development
—
135,000
General and administrative
1,964,990
1,236,127
Depreciation
6,841
12,455
Total operating expenses
3,564,063
2,661,871
Loss from operations
(3,564,063
)
(2,661,871
)
Other income:
Change in fair value of convertible
promissory notes
—
(1,398,375
)
Other income, net
142,089
39,420
Net loss
$
(3,421,974
)
$
(4,020,826
)
Per share information:
Net loss per share of common stock, basic
and diluted
$
(0.34
)
$
(1.55
)
Weighted-average shares of common stock
outstanding, basic and diluted
9,947,915
2,590,197
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 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 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20231108739587/en/
Investor Contact David Snyder
david@coyatherapeutics.com
Hayden IR: James Carbonara 646-755-7412
james@haydenir.com
Media Contact Anna Marie Imbordino
annamarie@quantum-corp.com 917-680-8765
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