HREC application submitted; on track to initiate Phase 1 clinical study of GT-02287 this year
Acceptance of late breaking abstract for presentation at the International Congress of Parkinson’s Disease and Movement Disorders® in Copenhagen, Denmark
BETHESDA, Md., Aug. 10, 2023 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. ( 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 | ||||||||
