Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”), a biotechnology company transforming drug discovery with its proprietary computational discovery platform identifying novel allosteric binding sites and creating small molecule treatments, today announced its financial results for the second quarter ended June 30, 2022, and highlighted recent corporate progress.

“We move into the second half of 2022 having made tangible progress across our pipeline,” said Eric Richman, Chief Executive Officer of Gain Therapeutics. “We continued to expand the body of positive preclinical data on our lead programs in Parkinson’s disease and Gaucher disease, respectively, GT-02287 and GT-02329, which we presented at key scientific conferences, further demonstrating the broad potential of our transformational SEE-Tx^® drug discovery platform.”

“SEE-Tx^® integrates advances in structural biology and supercomputing technology using a proprietary, patented algorithm to identify unique, never-before-described druggable binding sites on proteins in a fraction of the time of traditional pharmaceutical methods. This revolutionary technology positions Gain at the forefront of modern drug discovery approaches as we seek to break traditional drug discovery barriers and deploy leading-edge science to accelerate the discovery of novel therapies.”

Mr. Richman continued: “We are very encouraged by the accumulating preclinical data, which demonstrate proof-of-concept of the unique, potentially disease-modifying mechanism of action of these compounds. Based on these data, we believe that our first-in-class small molecule candidates will deliver upon our mission to provide new disease-modifying treatments for underserved patients suffering from genetically defined neurodegenerative diseases and lysosomal storage disorders. We look forward to continuing our progress and moving our lead Parkinson’s and Gaucher disease candidates, GT-02287 and GT-02329, through preclinical development and into the clinic.”

Business and Recent Developments

• Strong cash position to advance the Company’s programs. As of June 30, 2022, the Company’s cash position was $29.1 million, compared to $36.8 million as of December 31, 2021, positioning Gain with sufficient runway to reach value generating milestones. At this time, the Company anticipates that its existing cash, cash equivalents and marketable securities will enable it to fund its operating expenses and capital expenditure requirements into 2024.

• Presented positive preclinical data on small molecule lead compound GBA1 in Parkinson’s Disease (PD) program at the XXVII World Congress on Parkinson’s Disease and Related Disorders (IAPRD). In May, Gain presented data generated in two in vitro models and an in vivo model in a poster presentation titled “GT-02287, a Brain-Penetrant Structurally Targeted Allosteric Regulator for Glucocerebrosidase Shows Evidence of Pharmacological Efficacy in Models of Parkinson’s Disease.” The data showed the ability of lead compound GT-02287 to penetrate the brain, target and bind with the beta-glucocerebrosidase (GCase) protein, avoiding its degradation and allowing its transport to the lysosomes where the enzyme can carry out its necessary biological function.

• Presented positive preclinical data on Gaucher disease (GD) program at IWGGD Symposium. Also in May, Gain presented data generated in two different in vitro models in wild-type (WT) and patient-derived fibroblasts and in patient-derived dopaminergic neurons, as well as in an in vivo transgenic mouse model harboring the L444P mutation in an oral presentation titled “Bain-Penetrant Structurally Targeted Allosteric Regulators for Glucocerebrosidase (GCase) Show Promising Pharmacological Activity in L444P Models of Gaucher Disease.” The data show that the tested compounds increase the levels and activity of the beta-glucocerebrosidase protein, increase co-localization of GCase with lysosomes, and most importantly, decrease disease-causing toxic substrate accumulation in patient-derived fibroblasts and also in a transgenic mouse model of GD, supporting GT-02329’s potential as a therapy to mitigate the neurological effects of GD.

• Presented positive data on small molecule lead compound GBA1 in Parkinson’s Disease at the 2022 Synuclein Meeting. In April, Gain presented data generated in two different in vitro models covering both WT and the two most pathogenic GBA1 mutations L444P and N370S in a poster presentation titled “Targeting Glucocerebrosidase with Structurally Targeted Allosteric Regulators Corrects Abnormal Phenotypes in Models of Parkinson’s Disease.” The data showed that lead candidate GT-02287 is bioavailable, increases GCase levels, depletes alpha-synuclein, increases lysosomal health, and improves neuronal network and survival in relevant neuronal cell models.

• Continued to advance lead pipeline programs, including lead GBA1 compound in Parkinson’s Disease towards the clinic. The Company continues to advance GT-02287, a brain-penetrant Structurally Targeted Allosteric Regulator (STAR) of glucocerebrosidase for the treatment of Parkinson’s disease, into the clinic.

Upcoming Milestones

• Publication of further in vitro and in vivo data of our GBA1 Parkinson’s disease and Gaucher disease programs.
• Phase 1 first in human clinical trial initiation in our GBA1 Parkinson’s disease program.
• Advancement of GBA1 Gaucher disease program into IND-enabling toxicology studies.
• Advancement of lead series identification for Krabbe disease.
• Announcement of new oncology programs with SEE-Tx^® generated Structurally Targeted Allosteric Regulators.
• New preclinical data being presented at the International Parkinson's and Movement Society Disorder (MDS) annual conference, September 15-18 in Madrid, Spain. 

Financial Results

Revenues were $0.95 million for the three-month period ended June 30, 2022 compared to $0.89 million for the same period in 2021. The increase was primarily attributable to the timing and scope of development services under the collaboration agreement with Zentalis Pharmaceuticals.

Research and development expenses totaled $2.58 million for the three-month period ended June 30, 2022 compared to $1.79 million for the same period in 2021, an increase of $0.79 million. The increase in research and development expenses was primarily driven by increased program development activities related to the advancement of the Company’s pre-clinical pipeline, as well as increased personnel-related costs resulting from an increase in employee headcount, which includes the impact of non-cash stock-based compensation.

General and administrative expenses were $2.69 million for the three-month period ended June 30, 2022 compared to $1.81 million for the same period of 2021, an increase of $0.88 million. This increase was primarily due to an increase in personnel-related costs resulting from an increase in employee headcount, which includes the impact of non-cash stock-based compensation, an increase in expenses for legal fees relating to IP and corporate matters, and an increase in professional fees for accounting and investor relations as we continue to expand our business and build management infrastructure.

Total operating expenses increased to $5.27 million, which include the impact of non-cash stock-based compensation of $0.31 million, compared to $3.60 million in the second quarter 2021, which include the impact of non-cash stock-based compensation and warrants of $0.65 million.

Net loss was $5.08 million compared to $3.56 million in the second quarter 2021. The increase in net loss was due to increased research and development expenses, as well as an increase in general and administrative expenses primarily related to investments in the Company’s infrastructure as a publicly traded company.

GAAP basic and diluted net loss per share was $0.43, compared to basic and diluted net loss per share of $0.30 in the second quarter 2021.

Cash, cash equivalents and marketable securities were $29.1 million as of June 30, 2022 compared to $36.8 million at December 31, 2021.

GAIN THERAPEUTICS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited)

GAIN THERAPEUTICS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited)

About Gain Therapeutics, Inc.
Gain Therapeutics, Inc. is transforming drug discovery with its proprietary computational discovery platform identifying novel allosteric binding sites and creating small molecule treatments to address unmet medical needs. The ability to identify never-seen-before allosteric targets on proteins involved in diseases across the full spectrum of therapeutic areas provides 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, metabolic diseases, and 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, as well as from the Eurostars-2 joint program with co-funding from the European Union Horizon 2020 research and Innosuisse. For more information, please visit https://www.gaintherapeutics.com.

Cautionary Note Regarding Forward-Looking Statements
This press release contains "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," "potential" or "continue," the negative of these terms and other comparable terminology. 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. It is possible that actual results, including with respect to any financial forecast or the possibility of any future regulatory approval or filing, may differ materially from those anticipated in these forward-looking statements due to a number of factors, including but not limited to, risks detailed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the Securities and Exchange Commission on March 25, 2022, as well as other documents that may be filed by the Company from time to time. New risks and uncertainties arise over time, and it is not possible for us to predict all such factors or how they may affect us. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. We are under no duty to update any of these forward-looking statements after the date of this earnings release to conform these statements to actual results or revised expectations. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this earnings release.

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Noor Pahlavi
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