Gain Therapeutics Reports Financial Results for First Quarter 2024 and Provides Corporate Update
Gain Therapeutics (Nasdaq: GANX) has released its Q1 2024 financial results, reporting positive developments despite a decrease in both R&D and G&A expenses. The company announced favorable outcomes from the SAD part of its Phase 1 GT-02287 trial, initiated the MAD portion, and presented promising data on neuroprotection in Parkinson’s models.
Key executive appointments were made, with Gene Mack as CFO and Jonas Hannestad as CMO. The company maintains a cash runway into 2025, supported by potential grant applications. Financially, R&D expenses decreased by $0.3M to $2.5M, and G&A expenses fell by $0.6M to $1.9M. Net loss per share improved to $0.22 from $0.43 YoY. Cash reserves dropped to $12.7M from $16.8M year-end 2023.
- Positive results from the Single Ascending Dose (SAD) part of Phase 1 GT-02287 trial.
- Initiation of the Multiple Ascending Dose (MAD) part of the Phase 1 GT-02287 trial.
- Presented promising data on GT-02287's neuroprotection and motor function restoration.
- Strengthened management team with new CFO and CMO appointments.
- Cash runway guidance into 2025, potentially extendable with grants and business initiatives.
- Net loss per share reduced to $0.22 from $0.43 year-over-year.
- Decrease in cash, cash equivalents, and marketable securities to $12.7M from $16.8M year-end 2023.
- R&D expenses decreased by $0.3M, indicating potential slowing in development pace.
- G&A expenses decreased by $0.6M, primarily due to reduced legal, professional, and share-based compensation expenses.
- Despite improvements, the company still reported a net loss for the quarter.
Insights
Gain Therapeutics reported a reduction in R&D expenses by
General and administrative (G&A) expenses also saw a reduction, dropping by
For the quarter ended March 31, 2024, the company posted a GAAP net loss per share of
Cash reserves stood at
The positive results from the SAD part of the Phase 1 trial for GT-02287 are encouraging for investors. These results indicate that GT-02287 is moving forward in clinical trials, a critical step for any clinical-stage biotechnology company. The initiation of the MAD part of the trial is another vital milestone, suggesting progress in understanding the dosing and safety profile of the compound.
Data presented at the AD/PD 2024 and WORLDSymposium conferences underscore the potential of GT-02287 in treating GBA1 Parkinson's disease. Notably, the preclinical data indicating neuroprotection and restoration of motor function are promising, as they highlight the therapeutic potential of the compound. Investors should keep an eye on subsequent clinical data releases, which will be important in validating these preclinical findings.
The appointment of new executives, including a CFO and a Chief Medical Officer, suggests a strategic strengthening of the management team. While new appointments can bring fresh perspectives and expertise, their impact on the company's performance will depend on their ability to execute the corporate strategy effectively.
Gain Therapeutics' reiteration of its cash runway guidance into 2025 is a positive signal, providing some security about the company's financial health. However, the reliance on pending grant applications and other initiatives for potential extension of this runway introduces an element of uncertainty. Investors should monitor these developments closely, as securing additional funding will be critical for sustaining operations and advancing their clinical programs.
BETHESDA, Md., May 14, 2024 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”), a clinical-stage biotechnology company leading the discovery and development of the next generation of allosteric small molecule therapies, today reports financial results for the quarter ended March 31, 2024, and provides a corporate update.
Corporate Highlights from Q1 2024 to Date
- Announced Positive Results from the Single Ascending Dose (SAD) Part of the Phase 1 Clinical Trial of GT-02287
- Strengthened management team with appointment of Gene Mack as Chief Financial Officer and Jonas Hannestad, M.D., Ph.D. as Chief Medical Officer
- Presented data at AD/PD 2024 demonstrating mechanism of action of GT-02287, the Company’s lead compound being investigated for the treatment of GBA1 Parkinson’s disease
- Announced the initiation of the Multiple Ascending Dose (MAD) part of the Phase 1 clinical trial of GT-02287, a novel GCase-targeting small molecule therapy for GBA1 Parkinson’s disease
- Presented late-breaking data at the WORLDSymposium showing GT-02287 displays neuroprotection and completely restores motor function in preclinical models of Parkinson’s disease following delayed administration
- Reiterating cash runway guidance into 2025, which may be extended based on pending grant applications and other business initiatives
“Gain continues to be well positioned to achieve multiple clinical data-driven value inflection points with our lead program GT-02287 for GBA1 Parkinson’s disease during the course of this year and into 2025. Having bolstered our management team, we are able to do so with strong leadership and direction. We continue to execute on our operational plans and to meet near-term milestones,” said Matthias Alder, Gain Therapeutics’ CEO.
Q1 2024 Financial Results
Research and development (R&D) expenses decreased by
General and administrative (G&A) expenses decreased by
GAAP basic and diluted net loss per share for the quarter ended March 31, 2024, was
Cash, cash equivalent and marketable securities were
About Gain Therapeutics, Inc.
Gain Therapeutics, Inc. is a clinical-stage biotechnology company leading the discovery and development of next generation allosteric therapies. Gain’s lead drug candidate GT-02287 for the treatment of GBA1 Parkinson’s disease, is currently being evaluated in a Phase 1 clinical trial.
Leveraging AI-supported structural biology, proprietary algorithms and supercomputer-powered physics-based models, the company’s Magellan™ drug discovery platform can identify novel allosteric binding sites on disease-implicated proteins, pinpointing pockets that cannot be found or drugged with current technologies. Magellan™ is the next generation of Gain’s original SEE-Tx® (Site-Directed Enzyme Enhancement Therapy) platform, which was enhanced and expanded with new AI and machine-learning tools and virtual screening capabilities to access the emerging on-demand compound libraries covering vast chemical spaces of over five trillion compounds.
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 the timing of results from a Phase 1 clinical study for GT-02287; the potential therapeutic and clinical benefits of the Company’s product candidates; and the amount of time the Company’s current cash, cash equivalents and marketable securities will support operations. 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 Contact:
CORE IR
(516) 222-2560
ir@gaintherapeutics.com
Media Contacts:
Russo Partners
Nic Johnson and Elio Ambrosio
nic.johnson@russopartnersllc.com
elio.ambrosio@russopartnersllc.com
(212) 845-4242
| GAIN THERAPEUTICS, INC. | |||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||||||||
| (unaudited) | |||||||||
| Three Months Ended March 31, | |||||||||
| 2024 | 2023 | ||||||||
| Revenues: | |||||||||
| Collaboration revenues | $ | — | $ | 55,180 | |||||
| Other income | — | — | |||||||
| Total revenues | $ | — | $ | 55,180 | |||||
| Operating expenses: | |||||||||
| Research and development | (2,506,906 | ) | (2,791,205 | ) | |||||
| General and administrative | (1,870,794 | ) | (2,493,759 | ) | |||||
| Total operating expenses | (4,377,700 | ) | (5,284,964 | ) | |||||
| Loss from operations | $ | (4,377,700 | ) | $ | (5,229,784 | ) | |||
| Other income/(expense): | |||||||||
| Interest income, net | 115,303 | 152,035 | |||||||
| Foreign exchange gain/(loss), net | 268,077 | (42,842 | ) | ||||||
| Loss before income tax | $ | (3,994,320 | ) | $ | (5,120,591 | ) | |||
| Income tax | (19,874 | ) | (16,728 | ) | |||||
| Net loss | $ | (4,014,194 | ) | $ | (5,137,319 | ) | |||
| Net loss per shares: | |||||||||
| Net loss per share attributable to common stockholders - basic and diluted | $ | (0.22 | ) | $ | (0.43 | ) | |||
| Weighted average common shares - basic and diluted | 17,978,951 | 11,935,081 | |||||||
| GAIN THERAPEUTICS, INC. | |||||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||||
| (unaudited) | |||||||||
| March 31, | December 31, | ||||||||
| 2024 | 2023 | ||||||||
| Assets | |||||||||
| Current assets: | |||||||||
| Cash and cash equivalents | $ | 10,641,087 | $ | 11,794,949 | |||||
| Marketable securities - current | 2,019,414 | 4,999,704 | |||||||
| Tax credits | 249,133 | 242,577 | |||||||
| Prepaid expenses and other current assets | 952,889 | 741,638 | |||||||
| Total current assets | $ | 13,862,523 | $ | 17,778,868 | |||||
| Non-current assets: | |||||||||
| Property and equipment, net | $ | 111,909 | $ | 125,962 | |||||
| Internal-use software | 169,249 | 193,375 | |||||||
| Operating lease - right of use assets | 384,146 | 459,215 | |||||||
| Restricted cash | 31,744 | 34,021 | |||||||
| Long-term deposits and other non-current assets | 17,613 | 17,890 | |||||||
| Total non-current assets | 714,661 | 830,463 | |||||||
| Total assets | $ | 14,577,184 | $ | 18,609,331 | |||||
| Liabilities and stockholders’ equity | |||||||||
| Current liabilities: | |||||||||
| Accounts payable | $ | 1,405,154 | $ | 1,318,965 | |||||
| Operating lease liability - current | 204,569 | 229,693 | |||||||
| Other current liabilities | 2,368,806 | 2,160,366 | |||||||
| Deferred income - current | 914,759 | 1,122,138 | |||||||
| Loans - current | 110,848 | 118,797 | |||||||
| Total current liabilities | $ | 5,004,136 | $ | 4,949,959 | |||||
| Non-current liabilities: | |||||||||
| Defined benefit pension plan | $ | 292,486 | $ | 307,454 | |||||
| Operating lease liability - non-current | 177,365 | 229,855 | |||||||
| Deferred income - non-current | 64,300 | 94,786 | |||||||
| Loans - non-current | 396,836 | 449,053 | |||||||
| Total non-current liabilities | 930,987 | 1,081,148 | |||||||
| Total liabilities | $ | 5,935,123 | $ | 6,031,107 | |||||
| Stockholders’ equity | |||||||||
| Preferred stock, | — | — | |||||||
| Common stock, | 1,805 | 1,621 | |||||||
| Additional paid-in capital | 73,416,304 | 73,113,079 | |||||||
| Accumulated other comprehensive income | 21,863 | 247,241 | |||||||
| Accumulated deficit | (60,783,717 | ) | (38,516,197 | ) | |||||
| Loss for the period | (4,014,194 | ) | (22,267,520 | ) | |||||
| Total stockholders’ equity | 8,642,061 | 12,578,224 | |||||||
| Total liabilities and stockholders’ equity | $ | 14,577,184 | $ | 18,609,331 | |||||
FAQ
What were the key financial results reported by Gain Therapeutics (GANX) for Q1 2024?
What clinical updates did Gain Therapeutics announce in Q1 2024?
What changes occurred in Gain Therapeutics' management team in Q1 2024?
How did Gain Therapeutics' cash position change in Q1 2024?
What is Gain Therapeutics' guidance on cash runway as of Q1 2024?
