Bethesda, Md. — Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”), a biotechnology company leading the discovery and development of allosteric small molecule therapies, announced financial results for the full year ended December 31, 2022, and highlighted recent corporate progress.
“We have made significant progress across our pipeline this past year and have amassed additional and significant data supporting the disease modifying potential of our allosteric GCase regulators in Parkinson’s and Gaucher disease models,” said Matthias Alder, Chief Executive Officer. “We look forward to commencing the clinical program for GT-02287 with the submission of the dossier for the Phase 1 clinical trial by mid-2023. We are also pleased with the grant funding supporting the research program in Alpha-1 Antitrypsin Deficiency, which validates the versatility of our SEE-Tx platform and the new approach to address AAT deficiency-related metabolic diseases with allosteric small molecule regulators.”
Business Updates and Recent Developments
- GT-02287 in GBA1 Parkinson’s disease (PD) continues to advance towards the initiation of a Phase 1 clinical trial. Gain anticipates completing IND-enabling GLP toxicology studies in the first half of 2023 and commencing the clinical program with the submission of the dossier for the Phase 1 clinical trial of GT-02287 by mid-2023. The Phase 1 clinical trial will be conducted in Australia and will evaluate administration of both single and multiple ascending dose levels of GT-02287 in healthy volunteers to assess safety and pharmacokinetics, with the goal of identifying an optimal dose level for Phase 2 development.
- Presented preclinical data for GT-02329 at the 19th Annual WORLDSymposium™ in February 2023. In February, Gain presented new preclinical data in a poster presentation titled: “GT-02329, a Structurally Targeted Allosteric Regulator of GCase, Restores GCase Activity, Reduces Microgliosis and Improves Fine Locomotor Skills in the CBE Model of Neuronopathic Gaucher Disease.” The data generated in an animal model of neuronopathic Gaucher disease (nGD) showed that GT-02329 restores β-glucocerebrosidase (GCase) activity, depletes accumulation of toxic lipid substrates, reduces neuroinflammation and improves neuromuscular function. These findings support the disease-modifying potential of GT-02329, a GCase-targeting allosteric regulator, for the treatment of nGD.
- €1.2 million non-dilutive grant awarded to Company-led consortium to advance research program in Alpha-1 Antitrypsin Deficiency. The Company recently announced that Eurostars and Innosuisse have awarded a grant in the aggregate amount of €1.2 million to a consortium led by Gain Therapeutics which includes the Institute for Research in Biomedicine, Newcells Biotech and the University of Helsinki. This grant supports a research project 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.
Upcoming Anticipated Milestones
- Completion of IND enabling studies of GT-02287 in H1 2023
- Dossier submission for Phase 1 clinical trial of GT-02287 in GBA1 PD program by mid-2023, with initiation of clinical trial expected to commence in Australia in H2 2023
- Advancement of lead series identification for Krabbe disease in H1 2023
- Continued advancement of pre-clinical oncology programs; Company expects to identify lead series by the end of 2023
Financial Results:
Research and development expenses (R&D) for 2022 were $8.38 million, as compared to $7.16 million in 2021. The $1.22 million increase in R&D expense in 2022 compared to 2021 was primarily due to increases in external collaborations and related expenses, such as expenditures attributable to pre-IND clinical studies, quality and clinical manufacturing as the Company’s GBA1 PD research programs move toward clinical stage. The variance is due to higher personnel-related costs resulting from an increase in employee headcount and stock-based compensation expenses.
General and administrative (G&A) expenses for 2022 were $9.54 million, as compared to $6.82 million in 2021. The $2.72 million increase in G&A expenses in 2022 compared to 2021 was primarily due to increases in expenses for legal fees relating to patent and corporate matters, as well as increased accounting, insurance, information technology, investor relations and other expenses as the Company continues to expand its infrastructure to support operations as a public company. Higher personnel-related costs resulting from an increase in employee headcount and stock-based compensation expenses also contributed to the increase in G&A expenses.
Net loss for the year ended December 31, 2022 was $17.59 million, compared to a net loss of $13.89 million for the year ended December 31, 2021. Net loss as of December 31, 2022 included non-cash compensation expenses of $1.53 million as compared to 2021 non-cash compensation expenses of $1.87 million. The increase in net loss for 2022 compared to 2021 was primarily attributable to increases in G&A expenses of $2.72 million and R&D expenses of $1.22 million.
GAAP basic and diluted net loss per share for the year ended December 31, 2022 was $1.48, as compared to basic and diluted net loss per share of $1.37 as of December 31, 2021.
As of December 31, 2022, the Company had cash, cash equivalents and marketable securities totaling $22.1 million for the year ended December 31, 2022. 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 Q2 2024.
| GAIN THERAPEUTICS, INC. | ||||||||
| CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||
| (audited) | ||||||||
| Year Ended December 31, | ||||||||
| 2022 | 2021 | |||||||
| Revenues: | ||||||||
| Collaboration revenues | $ | 132,640 | $ | 133,928 | ||||
| Other income | 7,468 | 31,066 | ||||||
| Total revenues | 140,108 | 164,994 | ||||||
| Operating expenses: | ||||||||
| Research and development | (8,377,290 | ) | (7,164,229 | ) | ||||
| General and administrative | (9,539,863 | ) | (6,826,938 | ) | ||||
| Total operating expenses | (17,917,153 | ) | (13,991,167 | ) | ||||
| Loss from operations | (17,777,045 | ) | (13,826,173 | ) | ||||
| Other income (expense): | ||||||||
| Interest income, net | 375,357 | 12,495 | ||||||
| Foreign exchange loss, net | (96,074 | ) | (72,920 | ) | ||||
| Loss before income tax | $ | (17,497,762 | ) | $ | (13,886,598 | ) | ||
| Income tax | (92,976 | ) | (4,008 | ) | ||||
| Net loss | $ | (17,590,738 | ) | $ | (13,890,606 | ) | ||
| Net loss per shares: | ||||||||
| Net loss per share attributable to common stockholders – basic and diluted | $ | (1.48 | ) | $ | (1.37 | ) | ||
| Weighted average common shares – basic and diluted | 11,883,368 | 10,165,404 | ||||||
| Gain Therapeutics, Inc | |||||||||
| Consolidated Balance Sheets | |||||||||
| (audited) | |||||||||
| December 31, | December 31, | ||||||||
| 2022 | 2021 | ||||||||
| Assets | |||||||||
| Current assets: | |||||||||
| Cash and cash equivalents | $ | 7,311,611 | $ | 36,880,673 | |||||
| Marketable securities – current | 12,826,954 | — | |||||||
| Tax credits | 103,877 | 113,586 | |||||||
| Prepaid expenses and other current assets | 848,854 | 727,785 | |||||||
| Total current assets | $ | 21,091,296 | $ | 37,722,044 | |||||
| Non-current assets: | |||||||||
| Marketable securities – non current | $ | 1,941,488 | $ | — | |||||
| Property and equipment, net | 144,379 | 105,986 | |||||||
| Internal-use software | 213,967 | 202,609 | |||||||
| Operating lease – right of use assets | 659,933 | 901,042 | |||||||
| Restricted cash | 30,818 | 31,279 | |||||||
| Long-term deposits and other non-current assets | 17,506 | 22,111 | |||||||
| Total non-current assets | 3,008,091 | 1,263,027 | |||||||
| Total assets | $ | 24,099,387 | $ | 38,985,071 | |||||
| Liabilities and stockholder’s equity | |||||||||
| Current liabilities: | |||||||||
| Accounts payable | $ | 1,626,100 | $ | 560,479 | |||||
| Operating lease liability – current | 229,080 | 219,137 | |||||||
| Other current liabilities | 2,106,756 | 1,402,600 | |||||||
| Deferred income | 55,180 | 266,504 | |||||||
| Loans – current | 108,135 | 103,826 | |||||||
| Total current liabilities | $ | 4,125,251 | $ | 2,552,546 | |||||
| Non-current liabilities: | |||||||||
| Defined benefit pension plan | $ | 157,580 | $ | 329,458 | |||||
| Operating lease liability – non-current | 441,784 | 695,053 | |||||||
| Loans – non-current | 495,258 | 590,468 | |||||||
| Total non-current liabilities | 1,094,622 | 1,614,979 | |||||||
| Total liabilities | $ | 5,219,873 | $ | 4,167,525 | |||||
| Stockholders’ equity | |||||||||
| Preferred stock, $0.0001 par value; 10,000,000 shares authorized; nil shares issued and outstanding as of December 31, 2022 and 2021 | $ | — | $ | — | |||||
| Common stock, $0.0001 par value: 50,000,000 shares authorized; 11,883,368 issued and outstanding as of December 31, 2022 and December 31, 2021 | 1,189 | 1,189 | |||||||
| Additional paid-in capital | 57,358,895 | 55,832,461 | |||||||
| Accumulated other comprehensive income / (loss) | 35,627 | (90,645 | ) | ||||||
| Accumulated deficit | (20,925,459 | ) | (7,034,853 | ) | |||||
| Loss of the period | (17,590,738 | ) | (13,890,606 | ) | |||||
| Total stockholders’ equity | 18,879,514 | 34,817,546 | |||||||
| Total liabilities and stockholders’ equity | $ | 24,099,387 | $ | 38,985,071 | |||||
About Gain Therapeutics, Inc.
Gain Therapeutics, Inc. is leading the discovery and development of allosteric small molecules therapies. 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 (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, 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.