Gain Therapeutics Announces Second Quarter 2023 Financial Results and Business Update
10 8월 2023 - 8:00PM
Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”),
a biotechnology company leading the discovery and development of
the next generation of allosteric small molecule therapies, today
announced financial results for the second quarter ended June 30,
2023, and highlighted recent corporate progress.
“We are excited to announce the submission of the dossier
application to begin Phase 1 clinical trials of GT-02287, our
GCase-targeting drug candidate for GBA1 Parkinson’s disease,” said
Matthias Alder, Chief Executive Officer of Gain Therapeutics.
“GT-02287 has demonstrated positive preclinical results with
potential application across a range of neurodegenerative diseases
beyond GBA1 Parkinson’s disease. We look forward to commencing the
evaluation of the safety of this promising candidate in healthy
volunteers in the second half of this year.”
Pipeline Updates
- Submitted dossier to initiate Phase 1 clinical trial in
Australia. The preclinical data package that has been
submitted to the Human Research Ethics Committee (HREC)
demonstrates the safety, efficacy, and tolerability of GT-02287 in
preclinical models. The Phase 1 clinical trial, which is expected
to commence in H2 2023, will evaluate GT-02287 in healthy
volunteers to assess safety and pharmacokinetics, with the goal of
identifying an optimal dose level for Phase 1b and Phase 2
trials.
- Acceptance
of a late breaking abstract with new in vivo data on
GT-02287 for presentation at the upcoming International Congress of
Parkinson's Disease and Movement Disorders® to be held August
27-31, in Copenhagen, Denmark.
Upcoming Milestones
- Initiation of Phase 1 clinical trial of GT-02287 in Australia
expected in H2 2023.
- Presentation of two posters with new in vivo data at the
upcoming International Congress of Parkinson's Disease and Movement
Disorders® being held August 27-31, in Copenhagen, Denmark.
- Neuroprotective effect of GT-02287, a brain-penetrant
structurally targeted allosteric regulator of glucocerebrosidase,
leads to a significant reduction of plasma neurofilament light
chain levels and improvement in behavioral deficits in a mouse
model of GBA1 Parkinson’s disease (Late-breaker Abstract
#LBA-13).
- GT-02287, a brain-penetrant structurally targeted allosteric
regulator for glucocerebrosidase shows evidence of pharmacological
efficacy in an animal model of Parkinson’s disease (Abstract
#1376).
- Progression of one of the Company’s oncology programs to lead
series selection by the end of 2023.
Financial Results
Research and development (R&D) expenses
totaled $4.0 million for the three months ended June 30, 2023,
compared to $2.6 million for the same period in 2022. The $1.4
million increase in R&D expense was primarily due to increases
in costs associated with preclinical studies, quality and clinical
manufacturing as Gain’s GBA1 Parkinson’s disease program advances
toward clinical trials. The increase in R&D expense was also
due to higher personnel-related costs associated with an increase
in employee headcount.
General and administrative (G&A) expenses
totaled $3.7 million for the three months ended June 30, 2023,
compared to $2.7 million for the same period in 2022. The increase
in G&A expenses of $1.0 million was primarily due to higher
legal fees, accounting, information technology costs and increased
investor relations expenses. The increase in G&A expenses was
also due to an increase in personnel-related costs.
Net loss for the three months ended June 30,
2023, was $7.7 million, or $0.62 per share basic and diluted,
including non-cash stock-based compensation expense of $1.3
million, compared to a net loss of $5.1 million, or $0.43 per share
basic and diluted, which included non-cash stock-based compensation
expense of $0.4 million for the period ended June 30, 2022.
Cash, cash equivalents and marketable
securities were $16.2 million as of June 30, 2023, which
the Company believes is sufficient to support operations into the
third quarter of 2024.
|
GAIN THERAPEUTICS, INC.CONDENSED
CONSOLIDATED STATEMENTS OF
OPERATIONS(unaudited) |
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration revenues |
|
$ |
— |
|
|
$ |
95,102 |
|
|
$ |
55,180 |
|
|
$ |
132,640 |
|
Other income |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
7,468 |
|
Total revenues |
|
$ |
— |
|
|
$ |
95,102 |
|
|
$ |
55,180 |
|
|
$ |
140,108 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
(3,987,943 |
) |
|
|
(2,582,224 |
) |
|
|
(6,779,148 |
) |
|
|
(4,138,664 |
) |
General and administrative |
|
|
(3,743,171 |
) |
|
|
(2,689,263 |
) |
|
|
(6,236,930 |
) |
|
|
(4,466,306 |
) |
Total operating expenses |
|
|
(7,731,114 |
) |
|
|
(5,271,487 |
) |
|
|
(13,016,078 |
) |
|
|
(8,604,970 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
$ |
(7,731,114 |
) |
|
$ |
(5,176,385 |
) |
|
$ |
(12,960,898 |
) |
|
$ |
(8,464,862 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income/(expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income, net |
|
|
129,929 |
|
|
|
59,899 |
|
|
|
281,964 |
|
|
|
58,248 |
|
Foreign exchange gain/(loss), net |
|
|
(60,195 |
) |
|
|
40,212 |
|
|
|
(103,037 |
) |
|
|
59,374 |
|
Loss before income tax |
|
$ |
(7,661,380 |
) |
|
$ |
(5,076,274 |
) |
|
$ |
(12,781,971 |
) |
|
$ |
(8,347,240 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax |
|
|
(26,589 |
) |
|
|
(9,146 |
) |
|
|
(43,317 |
) |
|
|
(10,823 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(7,687,969 |
) |
|
$ |
(5,085,420 |
) |
|
$ |
(12,825,288 |
) |
|
$ |
(8,358,063 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per shares: |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share
attributable to common stockholders - basic and diluted |
|
$ |
(0.62 |
) |
|
$ |
(0.43 |
) |
|
$ |
(1.05 |
) |
|
$ |
(0.70 |
) |
Weighted average common shares
- basic and diluted |
|
|
12,387,089 |
|
|
|
11,883,368 |
|
|
|
12,157,969 |
|
|
|
11,883,368 |
|
|
GAIN THERAPEUTICS, INC.CONDENSED
CONSOLIDATED BALANCE
SHEETS(unaudited) |
|
|
|
June 30, |
|
December 31, |
|
|
2023 |
|
2022 |
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
6,319,925 |
|
|
$ |
7,311,611 |
|
Marketable securities - current |
|
|
9,873,209 |
|
|
|
12,826,954 |
|
Tax credits |
|
|
160,730 |
|
|
|
103,877 |
|
Prepaid expenses and other current assets |
|
|
954,584 |
|
|
|
848,854 |
|
Total current assets |
|
$ |
17,308,448 |
|
|
$ |
21,091,296 |
|
|
|
|
|
|
|
|
Non-current assets: |
|
|
|
|
|
|
Marketable securities - non current |
|
$ |
— |
|
|
$ |
1,941,488 |
|
Property and equipment, net |
|
|
138,556 |
|
|
|
144,379 |
|
Internal-use software |
|
|
204,549 |
|
|
|
213,967 |
|
Operating lease - right of use assets |
|
|
559,771 |
|
|
|
659,933 |
|
Restricted cash |
|
|
31,816 |
|
|
|
30,818 |
|
Long-term deposits and other non-current assets |
|
|
17,734 |
|
|
|
17,506 |
|
Total non-current assets |
|
|
952,426 |
|
|
|
3,008,091 |
|
Total assets |
|
$ |
18,260,874 |
|
|
$ |
24,099,387 |
|
|
|
|
|
|
|
|
Liabilities and
stockholders' equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
924,390 |
|
|
$ |
1,626,100 |
|
Operating lease liability - current |
|
|
235,798 |
|
|
|
229,080 |
|
Other current liabilities |
|
|
3,247,233 |
|
|
|
2,106,756 |
|
Deferred income - current |
|
|
1,069,107 |
|
|
|
55,180 |
|
Loans - current |
|
|
111,636 |
|
|
|
108,135 |
|
Total current liabilities |
|
$ |
5,588,164 |
|
|
$ |
4,125,251 |
|
|
|
|
|
|
|
|
Non-current liabilities: |
|
|
|
|
|
|
Defined benefit pension plan |
|
$ |
174,185 |
|
|
$ |
157,580 |
|
Operating lease liability - non-current |
|
|
330,071 |
|
|
|
441,784 |
|
Deferred income - non-current |
|
|
608,982 |
|
|
|
— |
|
Loans - non-current |
|
|
466,638 |
|
|
|
495,258 |
|
Total non-current
liabilities |
|
|
1,579,876 |
|
|
|
1,094,622 |
|
Total liabilities |
|
$ |
7,168,040 |
|
|
$ |
5,219,873 |
|
|
|
|
|
|
|
|
Stockholders’ equity |
|
|
|
|
|
|
Preferred stock, $0.0001 par value; 10,000,000 shares authorized;
nil shares issued and outstanding as of June 30, 2023 and December
31, 2022. |
|
|
— |
|
|
|
— |
|
Common stock, $0.0001 par value: 50,000,000 shares authorized;
12,632,327 issued and outstanding as of June 30, 2023; 11,883,368
issued and outstanding as of December 31, 2022. |
|
|
1,263 |
|
|
|
1,189 |
|
Additional paid-in capital |
|
|
62,298,733 |
|
|
|
57,358,895 |
|
Accumulated other comprehensive income |
|
|
134,323 |
|
|
|
35,627 |
|
Accumulated deficit |
|
|
(38,516,197 |
) |
|
|
(20,925,459 |
) |
Loss for the period |
|
|
(12,825,288 |
) |
|
|
(17,590,738 |
) |
Total stockholders’ equity |
|
|
11,092,834 |
|
|
|
18,879,514 |
|
Total liabilities and
stockholders’ equity |
|
$ |
18,260,874 |
|
|
$ |
24,099,387 |
|
About Gain Therapeutics, Inc.
Gain Therapeutics, Inc. is a biotechnology company leading the
discovery and development of next generation allosteric therapies.
Gain’s lead drug candidate GT-02287, in development for the
treatment of GBA1 Parkinson’s disease, has completed IND-enabling
GLP toxicology studies. Clinical evaluation of GT-02287 is expected
to begin this year.
Leveraging AI-supported structural biology, proprietary
algorithms and supercomputer-powered physics-based models, the
company’s SEE-Tx® discovery platform can identify novel allosteric
binding sites on disease-implicated proteins, pinpointing pockets
that cannot be found or drugged with current technologies. Gain’s
unique approach enables the discovery of novel, allosteric small
molecule modulators that can restore or disrupt protein function.
Deploying its highly advanced platform, Gain is accelerating drug
discovery and unlocking novel disease-modifying treatments for
untreatable or difficult-to-treat disorders including
neurodegenerative diseases, rare genetic disorders and oncology.
For more information, please visit GainTherapeutics.com and
follow us on LinkedIn.
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 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 of commencement of a Phase 1 clinical program for GT-02287
for GBA1 Parkinson’s disease; the potential therapeutic and
clinical benefits of the Company’s product candidates; the
selection and development, and timing thereof, of future programs
including the selection of a lead series for its preclinical
oncology program; the Company’s financial position and ability to
execute on the next phase of its strategy; and the Company’s
anticipated cash runway guidance, including the ability for the
Company’s current and projected cash to allow the Company to meet
value inflection points. 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 post-COVID-19
environment 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:
Susan SharpeLinnden Communications(919)
602-2330susan@linndencom.com
Gain Therapeutics (NASDAQ:GANX)
과거 데이터 주식 차트
부터 4월(4) 2024 으로 5월(5) 2024
Gain Therapeutics (NASDAQ:GANX)
과거 데이터 주식 차트
부터 5월(5) 2023 으로 5월(5) 2024