Gain Therapeutics Reports First Quarter 2023 Financial Results and Business Update – Yahoo Finance

Gain Therapeutics, Inc.

Successfully completed GLP toxicology studies for lead program GT-02287 in GBA1 Parkinsons disease

Company is on track to submit application for start of Phase 1 clinical trial of GT-02287 to the Human Research Ethics Committee (HREC) in Australia in mid-2023

Received a $2.8 million (CHF $2.5 million) grant from Innosuisse, the Swiss Innovation Agency, to advance the development of GT-02287 in GBA1 Parkinsons disease

Obtained a grant in the aggregate amount of $1.3 million (EUR 1.2 million) to a consortium led by Gain Therapeutics for further development of the Companys novel small molecule allosteric regulators against Alpha-1 Antitrypsin Deficiency

Appointed C. Evan Ballantyne as Chief Financial Officer in April

BETHESDA, Md., May 12, 2023 (GLOBE NEWSWIRE) -- 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 Parkinsons 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 Gains 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 Parkinsons 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 Alzheimers disease at the AD/PD conference in Gothenburg, Sweden. In March, Gain presented new preclinical data at the 2023 International Conference on Alzheimers and Parkinsons 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 Alzheimers Disease. The data generated in two cell-based assays of Alzheimers disease showed that Gains orally bioavailable, brain-penetrant allosteric regulators of GCase show promising activity against Amyloid Beta 1-42 (A-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.

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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 Parkinsons disease. The funding provided by Innosuisse, the Swiss Innovation Agency, as part of its Swiss Accelerator program to Gains Swiss subsidiary GT Gain Therapeutics SA, will support clinical pharmacology and preclinical studies with Gains drug candidate GT-02287, which are required to be performed as Gains lead program for the treatment of GBA1 Parkinsons 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 Companys 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 Gains GBA1 Parkinsons 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 March31,

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

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Gain Therapeutics Reports First Quarter 2023 Financial Results and Business Update - Yahoo Finance