Gain Therapeutics Reports First Quarter 2023 Financial Results and Business Update
12 May 2023 - 10:00PM
Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”),
a biotechnology company leading the discovery and development of
allosteric small molecule therapies, today announced financial
results for the first quarter ended March 31, 2023, and highlighted
recent corporate progress.
“We are pleased with the progress we have made
this year and look forward to advancing our lead candidate GT-02287
for the treatment of GBA1 Parkinson’s disease into the clinic later
this year,” said Matthias Alder, Chief Executive Officer. “In
addition, the grants obtained for the development of GT-02287 and
our AAT research program provide significant non-dilutive capital
and validate the potential of Gain’s allosteric protein regulators
as small molecule therapies in a broad range of diseases. Further,
we are thrilled that Evan Ballantyne joined us last month as our
new Chief Financial Officer to support the continued growth of Gain
at this important inflection point when we are poised to become a
clinical stage biotech company.”
Recent Pipeline Highlights
- Successfully completed GLP
toxicology studies for lead program GT-02287 in GBA1 Parkinson’s
disease. With the completion of GLP-toxicology studies,
Gain remains on track to submit the application for the initiation
of a Phase 1 clinical trial of GT-02287 to the Human Research
Ethics Committee (HREC) in Australia in mid-2023. The Phase 1
clinical trial is expected to commence in the second half of 2023
and will evaluate administration of both single and multiple
ascending dose levels of GT-02287 in healthy volunteers to assess
safety and pharmacokinetics.
- Presented positive
preclinical data supporting disease-modifying potential of
allosteric GCase regulators for the treatment of Alzheimer’s
disease at the AD/PD conference in Gothenburg, Sweden. In
March, Gain presented new preclinical data at the 2023
International Conference on Alzheimer’s and Parkinson’s Diseases
and related neurological disorders (AD/PD) in a poster presentation
titled: “Small-Molecule Structurally Targeted Allosteric Regulators
of Glucocerebrosidase Show Neuroprotective Properties in Cell-Based
Models of Alzheimer’s Disease.” The data generated in two
cell-based assays of Alzheimer’s disease showed that Gain’s orally
bioavailable, brain-penetrant allosteric regulators of GCase show
promising activity against Amyloid Beta 1-42 (Aβ-1-42) and
oligomeric Tau toxicity, which are thought to underlie
neurodegeneration and cognitive impairment in Alzheimer's disease,
supporting their potential as a disease-modifying, novel
pharmacological option for the treatment of AD and other
tauopathies.
Recent Corporate Updates
- Appointed C. Evan
Ballantyne as Chief Financial Officer in April 2023. Mr.
Ballantyne brings over 20 years of experience managing the
financing and corporate strategy of publicly traded and private
companies in the healthcare industry.
- Received a $2.8 million
(CHF 2.5 million) grant to advance lead program in GBA1 Parkinson’s
disease. The funding provided by Innosuisse, the Swiss
Innovation Agency, as part of its Swiss Accelerator program to
Gain’s Swiss subsidiary GT Gain Therapeutics SA, will support
clinical pharmacology and preclinical studies with Gain’s drug
candidate GT-02287, which are required to be performed as Gain’s
lead program for the treatment of GBA1 Parkinson’s disease
progresses through Phase 1 and Phase 2 clinical studies.
- Obtained a grant in the
aggregate amount of $1.3 million (EUR 1.2 million) to a consortium
led by Gain Therapeutics for AAT research program. The
grant awarded to the consortium will support a research project
conducted by Gain Therapeutics, the Institute for Research in
Biomedicine, Newcells Biotech and the University of Helsinki to
develop the Company’s novel small molecule allosteric regulators
against Alpha-1 Antitrypsin (AAT) Deficiency, a rare genetic
condition that can result in serious lung and liver diseases.
Financial Results:
Research and development (R&D) expenses
totaled $2.8 million for the three months ended March 31, 2023, as
compared to $1.6 million for the same period in 2022. The $1.2
million increase in R&D expense for the three months ended
March 31, 2023 was primarily due to increases in costs associated
with pre-IND clinical studies, quality and clinical manufacturing
as Gain’s GBA1 Parkinson’s disease program advances toward clinical
trials. The increase in R&D expenses was also due to higher
personnel-related costs associated with an increase in employee
headcount.
General and administrative (G&A) expenses
totaled $2.5 million for the three months ended March 31, 2023, as
compared to $1.8 million for the same period in 2022. The increase
in G&A expenses of $0.7 million for the three months ended
March 31, 2023 was primarily due to higher legal fees, accounting,
insurance, and information technology costs. The increase in
G&A expenses was also due to an increase in personnel-related
costs resulting from an increase in employee headcount.
Net loss for the three-month period ended March
31, 2023, was $5.1 million, or $0.43 per share basic and diluted,
compared to a net loss of $3.3 million, or $0.28 per share basic
and diluted, for the same period in 2022. The net loss includes
non-cash stock-based compensation expenses in the amount of $0.6
million and $0.3 million for the three-month periods ended March
31, 2023 and 2022, respectively.
Cash, cash equivalents and marketable securities
were $18.8 million as of March 31, 2023. The Company believes that
this amount, together with the proposed research grant funding
detailed above and ATM proceeds received in April 2023, will be
sufficient to support current operations into the third quarter of
2024.
GAIN THERAPEUTICS, INC. |
|
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS |
|
(unaudited) |
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
2023 |
|
2022 |
Revenues: |
|
|
|
|
|
|
Collaboration revenues |
|
$ |
55,180 |
|
|
$ |
37,538 |
|
Other income |
|
|
- |
|
|
|
7,468 |
|
Total revenues |
|
|
55,180 |
|
|
|
45,006 |
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
|
(2,791,205 |
) |
|
|
(1,556,440 |
) |
General and administrative |
|
|
(2,493,759 |
) |
|
|
(1,777,043 |
) |
Total operating expenses |
|
|
(5,284,964 |
) |
|
|
(3,333,483 |
) |
|
|
|
|
|
|
|
Loss from operations |
|
|
(5,229,784 |
) |
|
|
(3,288,477 |
) |
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
Interest income/(expense), net |
|
|
152,035 |
|
|
|
(1,651 |
) |
Foreign exchange gain/(loss), net |
|
|
(42,842 |
) |
|
|
19,162 |
|
Loss before income tax |
|
$ |
(5,120,591 |
) |
|
$ |
(3,270,966 |
) |
|
|
|
|
|
|
|
Income tax |
|
|
(16,728 |
) |
|
|
(1,677 |
) |
|
|
|
|
|
|
|
Net loss |
|
$ |
(5,137,319 |
) |
|
$ |
(3,272,643 |
) |
|
|
|
|
|
|
|
Net loss per shares: |
|
|
|
|
|
|
Net loss per share
attributable to common stockholders - basic and diluted |
|
$ |
(0.43 |
) |
|
$ |
(0.28 |
) |
Weighted average common shares
- basic and diluted |
|
|
11,935,081 |
|
|
|
11,883,368 |
|
GAIN THERAPEUTICS, INC. |
|
CONDENSED CONSOLIDATED BALANCE SHEETS |
|
(unaudited) |
|
|
|
|
|
|
|
|
|
March 31, |
|
December 31, |
|
|
2023 |
|
2022 |
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
5,988,202 |
|
|
$ |
7,311,611 |
|
Marketable securities – current |
|
|
11,827,528 |
|
|
|
12,826,954 |
|
Tax credits |
|
|
137,383 |
|
|
|
103,877 |
|
Prepaid expenses and other current assets |
|
|
1,368,871 |
|
|
|
848,854 |
|
Total current assets |
|
$ |
19,321,984 |
|
|
$ |
21,091,296 |
|
|
|
|
|
|
|
|
Non-current assets: |
|
|
|
|
|
|
Marketable securities - non current |
|
$ |
988,388 |
|
|
$ |
1,941,488 |
|
Property and equipment, net |
|
|
144,636 |
|
|
|
144,379 |
|
Internal-use software |
|
|
208,913 |
|
|
|
213,967 |
|
Operating lease - right of use assets |
|
|
609,877 |
|
|
|
659,933 |
|
Restricted cash |
|
|
31,122 |
|
|
|
30,818 |
|
Long-term deposits and other non-current assets |
|
|
17,655 |
|
|
|
17,506 |
|
Total non-current assets |
|
|
2,000,591 |
|
|
|
3,008,091 |
|
Total assets |
|
$ |
21,322,575 |
|
|
$ |
24,099,387 |
|
|
|
|
|
|
|
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
2,213,489 |
|
|
$ |
1,626,100 |
|
Operating lease liability – current |
|
|
232,507 |
|
|
|
229,080 |
|
Other current liabilities |
|
|
2,599,763 |
|
|
|
2,106,756 |
|
Deferred income |
|
|
— |
|
|
|
55,180 |
|
Loans – current |
|
|
109,200 |
|
|
|
108,135 |
|
Total current liabilities |
|
$ |
5,154,959 |
|
|
$ |
4,125,251 |
|
|
|
|
|
|
|
|
Non-current liabilities: |
|
|
|
|
|
|
Defined benefit pension plan |
|
$ |
164,568 |
|
|
$ |
157,580 |
|
Operating lease liability - non-current |
|
|
385,922 |
|
|
|
441,784 |
|
Loans - non-current |
|
|
478,296 |
|
|
|
495,258 |
|
Total non-current
liabilities |
|
|
1,028,786 |
|
|
|
1,094,622 |
|
Total liabilities |
|
$ |
6,183,745 |
|
|
$ |
5,219,873 |
|
|
|
|
|
|
|
|
Stockholders’ equity |
|
|
|
|
|
|
Preferred stock, $0.0001 par value; 10,000,000 shares authorized;
nil shares issued and outstanding as of March 31, 2023 and December
31, 2022. |
|
|
— |
|
|
|
— |
|
Common stock, $0.0001 par value: 50,000,000 shares authorized;
12,087,142 issued and outstanding as of March 31, 2023; 11,883,368
issued and outstanding as of December 31, 2022. |
|
|
1,209 |
|
|
|
1,189 |
|
Additional paid-in capital |
|
|
58,694,827 |
|
|
|
57,358,895 |
|
Accumulated other comprehensive income |
|
|
96,310 |
|
|
|
35,627 |
|
Accumulated deficit |
|
|
(38,516,197 |
) |
|
|
(20,925,459 |
) |
Loss for the period |
|
|
(5,137,319 |
) |
|
|
(17,590,738 |
) |
Total stockholders’ equity |
|
|
15,138,830 |
|
|
|
18,879,514 |
|
Total liabilities and
stockholders’ equity |
|
$ |
21,322,575 |
|
|
$ |
24,099,387 |
|
About Gain Therapeutics, Inc.
Gain Therapeutics, Inc. is a biotechnology company leading the
discovery and development of allosteric small molecule therapies.
With its proprietary computational discovery platform SEE-Tx®, Gain
Therapeutics is transforming drug discovery by identifying novel
allosteric targets on proteins involved in diseases across the full
spectrum of therapeutic areas. By binding to allosteric binding
sites, the small molecules discovered with SEE-Tx provide
opportunities for a range of drug-protein interactions, including
protein stabilization, protein destabilization, targeted protein
degradation, allosteric inhibition, and allosteric activation.
Gain’s pipeline spans neurodegenerative diseases, lysosomal storage
disorders (LSDs), metabolic disorders, as well as other diseases
that can be targeted through protein degradation, such as oncology.
Gain’s lead program in Parkinson’s disease has been awarded funding
support from The Michael J. Fox Foundation for Parkinson’s Research
(MJFF) and The Silverstein Foundation for Parkinson’s with GBA, the
Eurostars-2 joint program with co-funding from the European Union
Horizon 2020 research and Innosuisse, and through a Swiss
Accelerator Innovation Project supported by Innosuisse. For more
information, please visit https://www.gaintherapeutics.com
Cautionary Note Regarding
Forward-Looking Statements This press release contains
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. All statements in this
press release other than statements of historical facts are
“forward-looking statements". In some cases, you can identify these
statements by forward-looking words such as "may," "might," "will,"
"should," "expect," "plan," "anticipate," "believe," "estimate,"
"predict," "goal, " "intend," "seek, " "potential" or "continue,"
the negative of these terms and variations of these words or
similar expressions that are intended to identify forward-looking
statements, although not all forward-looking statements contain
these words. Forward-looking statements in this press release
include, but are not limited to, statements regarding: the
Company’s growth and upcoming inflection points; the development of
the Company’s current or future product candidates including
GT-02287; expectations regarding timing for reporting data from
ongoing preclinical studies or the initiation of future clinical
trials, including the timing for submission of the application for
the initiation of the Phase 1 clinical trial of GT-02287 in
Australia and the timing for commencement of such clinical trial;
and the Company’s anticipated cash runway guidance. These
forward-looking statements are based on the Company’s expectations
and assumptions as of the date of this press release. Each of these
forward-looking statements involves risks and uncertainties that
could cause the Company’s preclinical and future clinical
development programs, future results or performance to differ
materially from those expressed or implied by the forward-looking
statements. These statements are not historical facts but instead
represent the Company's belief regarding future results, many of
which, by their nature, are inherently uncertain and outside the
Company's control. Many factors may cause differences between
current expectations and actual results, including the impacts of
the COVID-19 pandemic and other global and macroeconomic conditions
on the Company’s business; clinical trials and financial position;
unexpected safety or efficacy data observed during preclinical
studies or clinical trials, clinical trial site activation or
enrollment rates that are lower than expected; changes in expected
or existing competition; changes in the regulatory environment; the
uncertainties and timing of the regulatory approval process; and
unexpected litigation or other disputes. Other factors that may
cause the Company’s actual results to differ from those expressed
or implied in the forward-looking statements in this press release
are identified in the section titled “Risk Factors,” in the
Company’s Annual Report on Form 10-K filed with the Securities and
Exchange Commission on March 23, 2023 and its other documents
subsequently filed with or furnished to the Securities and Exchange
Commission from time to time. All forward-looking statements
contained in this press release speak only as of the date on which
they were made. The Company undertakes no obligation to update such
statements to reflect events that occur or circumstances that exist
after the date on which they were made, except as required by
law.
Investor & Media Contact:
Argot Partners(212) 600-1902Gain@argotpartners.com
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