Gain Therapeutics Reports Financial Results for Year End 2023 and Provides Corporate Update
- Gain Therapeutics reports financial results for 2023, showcasing advancements in Parkinson's disease therapies.
- Company presented data on GT-02287, initiated Phase 1 trials, and raised $10.1 million in proceeds.
- Net loss for 2023 was $22.3 million, with increased R&D and G&A expenses compared to 2022.
- Cash, cash equivalent, and marketable securities stood at $16.8 million as of December 31, 2023.
- Increased R&D and G&A expenses led to a net loss of $22.3 million for 2023.
- GAAP basic and diluted net loss per share increased to $1.71 for 2023 from $1.48 in 2022.
Insights
The reported increase in research and development (R&D) expenses by Gain Therapeutics reflects a strategic investment in the advancement of their lead drug candidate GT-02287. This uptick in spending is indicative of the company's transition from preclinical to clinical stages, which typically involves heightened costs due to human trials and regulatory compliance. The financial commitment towards R&D is often viewed positively by investors as it signals potential for future revenue streams upon successful drug approval. However, the corresponding rise in general and administrative (G&A) expenses, particularly due to non-cash costs like share-based compensation, requires scrutiny. While share-based compensation can align employee interests with shareholders, it also dilutes existing stock value and can be seen as a less favorable expense increase compared to direct R&D spending.
From a financial health perspective, the net loss widening from the previous year is a concern, but not uncommon for clinical-stage biotech firms focused on growth and development over immediate profitability. The key metric for investors will be the burn rate in relation to the company's cash runway. With a cash position forecasted to last into Q1 2025, there is a cushion for the company to reach significant clinical milestones without immediate additional financing needs. However, this also implies that future capital raises are likely, which could introduce further dilution or debt. The stock market reaction to such financial results will hinge on investor confidence in the company's ability to meet its clinical and operational milestones, which could lead to future revenue and profitability.
The initiation of the Multiple Ascending Dose (MAD) part of the Phase 1 clinical trial for GT-02287 is a critical step for Gain Therapeutics. This phase assesses the safety and tolerability of the drug at increasing dose levels, which is pivotal for determining the appropriate dosing for later-stage trials. The positive preclinical data suggesting neuroprotection and motor function restoration in models of Parkinson's disease is promising. However, the transition from preclinical to human trials is fraught with uncertainty and many compounds fail to replicate animal model efficacy in humans. The medical community will be watching closely for any signs of efficacy and safety in the ongoing and future trials.
Furthermore, the therapeutic potential for GLB1-related lysosomal storage disorders (LSDs) expands the impact of the company's research beyond Parkinson's disease. LSDs are a group of rare inherited metabolic disorders that can lead to severe clinical manifestations and new treatment options are desperately needed. The publication in a peer-reviewed journal like PLOS ONE lends credibility to the company's scientific approach and could have positive implications for the company's valuation if the therapies prove effective in clinical settings. The stock market often reacts favorably to such diverse pipelines, as they spread the risk across multiple potential revenue streams.
Gain Therapeutics' current position in the biotechnology market reflects a broader industry trend towards targeted therapies for neurodegenerative diseases and lysosomal storage disorders. The company's focus on allosteric small molecule therapies is of particular interest as this represents a novel approach in drug development, potentially offering a competitive edge. The successful progress of GT-02287 through clinical trials could capture a significant share of the Parkinson's disease treatment market, which is projected to grow given the aging global population.
However, the market's response to Gain Therapeutics' financial results and operational updates will depend on investor sentiment towards long-term value creation versus short-term financial performance. The biotech sector is known for its volatility and companies like Gain that are in the clinical trial phase can experience significant stock price movements based on trial outcomes. Investors will weigh the potential market opportunity against the risks associated with clinical development, regulatory hurdles and the need for future capital. The business's ability to maintain a transparent and consistent communication strategy regarding trial progress and financial health will be important in managing market expectations and stock volatility.
BETHESDA, Md., March 26, 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 year ended December 31, 2023 and provides a corporate update.
Corporate Highlights from Q4 2023 to Date
- 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
- Published data in PLOS ONE demonstrating therapeutic potential for galactosidase beta 1 (GLB1)-related lysosomal storage disorders (LSDs), including GM1 gangliosidosis
- Raised
$10.1 million in gross proceeds from public offering and concurrent private placement of common stock and warrants
“With the tremendous progress we have made over the course of 2023 and entering 2024, we believe Gain is 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. We believe our cash position and operational plans are strong and allow us to meet our near-term milestones,” said Matthias Alder, Gain Therapeutics’ CEO. “We are encouraged by the safety and tolerability profile of GT-02287 in healthy subjects that we have observed so far in the ongoing Phase 1 clinical trial and remain on track to complete that study by mid-year,” concluded Mr. Alder.
2023 Year End Financial Results
Research and development (R&D) expenses increased by
General and administrative (G&A) expenses increased by
Net loss for the year ended December 31, 2023 was
GAAP basic and diluted net loss per share for the year ended December 31, 2023 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 50 billion 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. Consolidated Statement of Operations | ||||||||
| Year Ended December 31, | ||||||||
| 2023 | 2022 | |||||||
| Revenues: | ||||||||
| Collaboration revenues | $ | 55,180 | $ | 132,640 | ||||
| Other income | — | 7,468 | ||||||
| Total revenues | 55,180 | 140,108 | ||||||
| Operating expenses: | ||||||||
| Research and development | (11,520,613 | ) | (8,377,290 | ) | ||||
| General and administrative | (10,787,700 | ) | (9,539,863 | ) | ||||
| Total operating expenses | (22,308,313 | ) | (17,917,153 | ) | ||||
| Loss from operations | (22,253,133 | ) | (17,777,045 | ) | ||||
| Other income (expense): | ||||||||
| Interest income, net | 494,234 | 375,357 | ||||||
| Foreign exchange loss, net | (429,346 | ) | (96,074 | ) | ||||
| Loss before income tax | $ | (22,188,245 | ) | $ | (17,497,762 | ) | ||
| Income tax | (79,275 | ) | (92,976 | ) | ||||
| Net loss | $ | (22,267,520 | ) | $ | (17,590,738 | ) | ||
| Net loss per shares: | ||||||||
| Net loss per share attributable to common stockholders - basic and diluted | $ | (1.71 | ) | $ | (1.48 | ) | ||
| Weighted average common stock - basic and diluted | 13,011,361 | 11,883,368 | ||||||
| Gain Therapeutics, Inc. Consolidated Balance Sheets | ||||||||
| December 31, 2023 | December 31, 2022 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 11,794,949 | $ | 7,311,611 | ||||
| Marketable securities - current | 4,999,704 | 12,826,954 | ||||||
| Tax credits | 242,577 | 103,877 | ||||||
| Prepaid expenses and other current assets | 741,638 | 848,854 | ||||||
| Total current assets | $ | 17,778,868 | $ | 21,091,296 | ||||
| Non-current assets: | ||||||||
| Marketable securities - non-current | $ | — | $ | 1,941,488 | ||||
| Property and equipment, net | 125,962 | 144,379 | ||||||
| Internal-use software | 193,375 | 213,967 | ||||||
| Operating lease - right of use assets | 459,215 | 659,933 | ||||||
| Restricted cash | 34,021 | 30,818 | ||||||
| Long-term deposits and other non-current assets | 17,890 | 17,506 | ||||||
| Total non-current assets | 830,463 | 3,008,091 | ||||||
| Total assets | $ | 18,609,331 | $ | 24,099,387 | ||||
| Liabilities and stockholder's equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,318,965 | $ | 1,626,100 | ||||
| Operating lease liability - current | 229,693 | 229,080 | ||||||
| Other current liabilities | 2,160,366 | 2,106,756 | ||||||
| Deferred income - current | 1,122,138 | 55,180 | ||||||
| Loans - current | 118,797 | 108,135 | ||||||
| Total current liabilities | $ | 4,949,959 | $ | 4,125,251 | ||||
| Non-current liabilities: | ||||||||
| Defined benefit pension plan | $ | 307,454 | $ | 157,580 | ||||
| Operating lease liability - non-current | 229,855 | 441,784 | ||||||
| Deferred income - non-current | 94,786 | — | ||||||
| Loans - non-current | 449,053 | 495,258 | ||||||
| Total non-current liabilities | 1,081,148 | 1,094,622 | ||||||
| Total liabilities | $ | 6,031,107 | $ | 5,219,873 | ||||
| Stockholders’ equity | ||||||||
| Preferred stock, outstanding as of December 31, 2023 and 2022 | $ | — | $ | — | ||||
| Common stock, outstanding as of December 31, 2023 and 11,883,368 shares issued and outstanding as of December 31, 2022 | 1,621 | 1,189 | ||||||
| Additional paid-in capital | 73,113,079 | 57,358,895 | ||||||
| Accumulated other comprehensive income | 247,241 | 35,627 | ||||||
| Accumulated deficit | (38,516,197 | ) | (20,925,459 | ) | ||||
| Loss of the period | (22,267,520 | ) | (17,590,738 | ) | ||||
| Total stockholders’ equity | 12,578,224 | 18,879,514 | ||||||
| Total liabilities and stockholders’ equity | $ | 18,609,331 | $ | 24,099,387 | ||||
FAQ
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