Gain Therapeutics, Inc. (GANX) Business Model Canvas

Gain Therapeutics, Inc. (GANX): Business Model Canvas [Dec-2025 Updated]

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You're digging into the nuts and bolts of a clinical-stage biotech, and for Gain Therapeutics, Inc., the business model boils down to two things: their proprietary Magellan AI platform and the progress of their lead candidate, $\text{GT-02287}$, which aims to be a disease-modifying therapy for Parkinson's. Honestly, looking at the books as of late 2025, you see the typical profile: they burned $\mathbf{\$5.3 \text{ million}}$ in the third quarter while pushing that Phase 1b trial, leaving them with $\mathbf{\$8.8 \text{ million}}$ in cash as of September 30, 2025. This canvas breaks down exactly how Gain Therapeutics, Inc. is trying to turn that R\&D spend into future licensing deals and, ultimately, a breakthrough treatment, so see below for the full strategic map.

Gain Therapeutics, Inc. (GANX) - Canvas Business Model: Key Partnerships

You're looking at the external relationships that are absolutely critical for Gain Therapeutics, Inc. (GANX) to move GT-02287 through the clinic and toward commercialization. These aren't just names on a slide; they represent validation, operational capacity, and future exit potential. Here's the breakdown as of late 2025.

Clinical Research Organizations (CROs) for Phase 1b Trial Execution in Australia

The execution of the Phase 1b trial in Australia required significant local operational partnerships, though the specific CRO name isn't public record here. What we do know is the scale of the trial itself, which is a key operational metric.

  • Phase 1b trial enrolled 21 participants.
  • Execution spanned 7 clinical sites in Australia.
  • The initial dosing period was for 3 months.
  • The extension study allows treatment for up to a total of 12 months.
  • Phase 2 planning for the US/EU was targeted for the second half of 2025.

Foundational and Governmental Financial Support

Non-dilutive funding from foundations and agencies has been a cornerstone of the early development of the lead program, GT-02287. This support validates the science before major pharma steps in. The company has raised a total of $12.8M over 4 funding rounds, including 2 Grant rounds.

The Michael J. Fox Foundation (MJFF) and The Silverstein Foundation for Parkinson's with GBA provided grant support early in development.

Partner Entity Type of Support/Interaction Relevant Financial/Date Data Point
The Michael J. Fox Foundation (MJFF) Grant Support for GBA-PD Program Investor in a Grant round on February 26, 2019
The Silverstein Foundation for Parkinson's with GBA Grant Support for GBA-PD Program Investor in a Grant round on February 26, 2019
Innosuisse (Swiss Innovation Agency) Grant Support (Swiss Accelerator) Awarded CHF 2.5 million (~$2.8 million) in May 2023
Eurostars-2 Joint Program / EU Horizon 2020 Co-funding for Lead Program Investor in a Grant round on July 23, 2019 ($1.35M)

To be fair, the cash position as of the end of the third quarter of 2025 reflects the burn rate against this funding: Cash, cash equivalent and marketable securities were $8.8 million as of September 30, 2025.

Academic Institutions and Key Opinion Leaders (KOLs) for Scientific Validation

Scientific validation is driven by engagement with leading experts who can contextualize the emerging clinical data. This partnership structure is key for building the narrative for future regulatory filings and licensing discussions.

  • KOL event hosted on October 14th, 2025.
  • KOL featured: Karl Kieburtz, M.D., M.P.H. (University of Rochester).
  • KOL featured: Kenneth Marek, M.D. (Institute for Neurodegenerative Disorders).
  • Grant support awarded together with Dr. Marta Martínez Vicente (Vall d\'Hebron Research Institute in Barcelona).

Potential Large Pharmaceutical Companies for Future Licensing/Acquisition Deals

While no specific deal amounts are public, the company's financing activities signal readiness for partnership discussions. The July 2025 proposed public offering was intended to fund continued clinical development of GT-02287. The company has multiple undisclosed preclinical assets targeting lysosomal storage disorders, metabolic diseases, and solid tumors, which represent potential future deal flow.

The lead candidate, GT-02287, has potential beyond Parkinson's disease, including Gaucher's disease, dementia with Lewy bodies, and Alzheimer's disease.

Gain Therapeutics, Inc. (GANX) - Canvas Business Model: Key Activities

You're managing the core engine of Gain Therapeutics, Inc. (GANX) right now, which means your key activities are laser-focused on pushing the lead candidate through critical clinical validation and keeping the discovery engine fed. Here's the breakdown of what's consuming the most time and resources as of late 2025.

Advancing lead candidate GT-02287 through Phase 1b clinical trials

The main push is getting meaningful data out of the Phase 1b trial for GT-02287 in Parkinson's disease (PD). You completed enrollment faster than planned, which is a win. The trial is an open-label study, meaning everyone gets the drug, and the initial dosing was for 90 days.

The commitment from participants is strong; approximately 80% of them agreed to continue in the extension phase, which allows dosing for up to a total of 12 months in Australian sites. You're tracking safety, tolerability, and, critically, functional changes and biomarkers. The first analysis of the 90-day data was expected in Q4 2025, with a full readout for 16 patients anticipated in December 2025.

Here's a snapshot of the Phase 1b cohort details based on the latest reports:

Metric Number/Status
Total Enrolled (as of Sept 2025) 21
Participants Assessed for Early Efficacy (Day 90) 14 (no TESAEs reported)
Participants on Stable PD Medication 18
Participants Treatment-naïve 2
Participants on Deep Brain Stimulation 2
Dosing Period Extension (Australia) Up to 12 months total

Remember, the prior Phase 1 study in healthy volunteers showed a statistically significant >50% increase in glucocerebrosidase (GCase) activity, which is the target engagement you need to see replicated here.

Proprietary drug discovery using the Magellan™ (AI-supported) platform

The Magellan™ platform is your engine for future pipeline growth. This proprietary artificial intelligence system is designed to look beyond what's in public databases, focusing on identifying novel, previously unexplored protein binding sites. This activity is about creating proprietary small molecules that can modulate protein function, which is how you found GT-02287.

The platform's utility isn't limited to PD; it's being deployed to unlock treatments for a range of disorders, including:

  • Neurodegenerative diseases
  • Rare genetic disorders
  • Oncology

To show its breadth, the platform was highlighted for its use in identifying allosteric inhibitors targeting discoidin domain receptor 2 (DDR2).

Regulatory filings, including the planned IND submission to the FDA by year-end 2025

This is a major near-term financial and operational hurdle. You've been working toward an Investigational New Drug (IND) submission to the U.S. Food and Drug Administration (FDA) planned for year-end 2025. This filing is key because it facilitates the expansion of the Phase 2 clinical development for GT-02287 to include U.S. clinical sites. You had a productive pre-IND meeting with the FDA in early December 2024, which provided encouraging feedback and suggested no significant regulatory hurdles for the submission.

Financially, the company's operations are being managed against this timeline. For the nine months ending September 30, 2025, the net loss was $15.6 million, down from $16.6 million for the same period in 2024. Research and Development (R&D) expenses for Q3 2025 specifically were $2.8 million. Cash on hand as of September 30, 2025, stood at $8.8 million, which you've stated should extend the cash runway past the completion of the Phase 1b study analysis.

Preclinical research for pipeline expansion in rare and neurodegenerative diseases

While GT-02287 is the clinical focus, the preclinical work is essential for long-term value. The mechanism of action for GT-02287-restoring GCase function-suggests potential utility beyond PD. This activity involves leveraging the data generated from the lead program to validate targets in other areas.

The potential indications for GT-02287 based on this preclinical work include:

  • Gaucher's disease
  • Dementia with Lewy bodies
  • Alzheimer's disease

Furthermore, Gain Therapeutics has multiple undisclosed preclinical assets in the works targeting lysosomal storage disorders, metabolic diseases, and solid tumors, all driven by the Magellan™ platform.

Investor and scientific community relations via conference presentations

Communicating progress is a non-stop activity, especially when clinical data is maturing. You've been active in presenting both preclinical and clinical findings to key audiences. For instance, early data suggesting a disease-slowing effect was presented at the 2025 MDS conference in Hawaii. More detailed early data from the Phase 1b study was presented on October 7, 2025, at the International Congress of Parkinson's Disease and Movement Disorders® in Honolulu, HI.

You also presented new preclinical data supporting GT-02287's role in supporting mitochondrial health via a poster at the Society for Neuroscience annual meeting, Neuroscience 2025, held November 15th-19th in San Diego, CA. Following the October data presentation, a Key Opinion Leader (KOL) webinar was scheduled for October 14, 2025, to contextualize the emerging data.

For the financial community, the Q3 2025 earnings call on November 12, 2025, was a key touchpoint, where the reported EPS was -$0.15, meeting the consensus estimate. Analysts are currently forecasting the FY2025 EPS to be ($1.00), though one firm, HC Wainwright, has a slightly less negative estimate of ($0.65).

Gain Therapeutics, Inc. (GANX) - Canvas Business Model: Key Resources

You're looking at the core assets that underpin Gain Therapeutics, Inc.'s ability to operate and advance its pipeline, especially as they move toward key data readouts. Honestly, in biotech, your resources are your science, your cash runway, and your people. Here's the breakdown of what Gain Therapeutics is leaning on as of late 2025.

The Proprietary Magellan™ AI-supported drug discovery platform is a major intangible asset. This technology transforms how they find new drugs by integrating Artificial Intelligence, physics-based modeling, and supercomputing power. The platform is designed to pinpoint novel allosteric binding sites and generate potential first-in-class drug candidates from on-demand libraries containing up to 5 trillion compounds in under 3 months.

The most tangible near-term resource is the financial cushion. As of September 30, 2025, Gain Therapeutics, Inc. reported Cash and cash equivalents of $8.8 million. This cash position, alongside the completion of a public offering in July 2025 that brought in approximately $7.1 million in net proceeds, was intended to extend the cash runway beyond the completion of the Phase 1b study. For context on recent operational burn, the net loss for the three months ended September 30, 2025, resulted in an Earnings Per Share (EPS) of -$0.15.

The lead clinical asset, GT-02287, is a first-in-class GCase allosteric modulator. This molecule is in a Phase 1b clinical trial for Parkinson's disease (PD) with or without a GBA1 mutation. The trial reached enrollment of 21 participants as of September 30, 2025, exceeding the initial target of 15. The company expects analysis of functional changes and biomarker activity from this study during the fourth quarter of 2025. Furthermore, the Phase 1b study extension allows participants to continue treatment for a total of up to 12 months.

The protection around these assets is critical. This includes the Intellectual property protecting the allosteric small molecule compounds, which covers GT-02287 and other pipeline candidates targeting lysosomal storage disorders, metabolic diseases, and solid tumors.

You can see the financial and clinical milestones that define the current resource utilization below:

Metric Value/Status Date/Period Citation
Cash and Cash Equivalents $8.8 million September 30, 2025 1
Phase 1b Enrollment (as of) 21 participants September 30, 2025 1
Phase 1b Initial Target Enrollment 15 participants N/A 1, 2
Expected Biomarker Analysis 4Q 2025 Late 2025 1, 6
Q3 2025 EPS -$0.15 Three Months Ended Sept 30, 2025 4
R&D Expenses $2.8 million Three Months Ended Sept 30, 2025 1

Finally, the Specialized scientific and clinical development personnel are the engine driving the program. Their work is reflected in the Research and Development (R&D) expenses, which were $2.8 million for the three months ended September 30, 2025, primarily due to costs associated with the ongoing Phase 1b trial. The team's expertise is also focused on advancing the Magellan platform and planning for Phase 2 development.

The key personnel-supported activities include:

  • Facilitating the ongoing Phase 1b clinical trial in Australia.
  • Engaging with the U.S. Food and Drug Administration (FDA) for Phase 2 expansion planning.
  • Advancing multiple undisclosed preclinical assets.
  • Managing the extension of the Phase 1b study dosing duration.

Finance: draft 13-week cash view by Friday.

Gain Therapeutics, Inc. (GANX) - Canvas Business Model: Value Propositions

You're looking at the core value Gain Therapeutics, Inc. (GANX) offers to patients and the market as of late 2025. It centers on delivering a true disease-modifying approach, not just masking symptoms for conditions like Parkinson's disease (PD).

Potential disease-modifying therapy for Parkinson's, not just symptomatic relief.

  • Preclinical data in rodent models of both GBA1-PD and idiopathic PD demonstrated a disease-modifying effect, including rescuing deficits in motor function and gait.
  • Early clinical findings from the Phase 1b study suggested a disease-slowing effect, shown by stabilization and improvement in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) scores appearing after approximately 30 days of administration.
  • The company is planning for Phase 2 studies in the US and EU in the second half of 2025.

Orally administered, brain-penetrant small molecule (GT-02287).

The lead candidate, GT-02287, is an orally administered, brain-penetrant small molecule, which is a significant convenience factor compared to infusions or injections for chronic neurological conditions.

Targeting the underlying cause (GCase misfolding) for both GBA1 and idiopathic PD.

GT-02287 acts as an allosteric enzyme modulator designed to restore the function of the lysosomal enzyme glucocerebrosidase (GCase). This mechanism addresses the root issue of GCase misfolding, which is implicated in both genetically defined PD (GBA1-PD) and idiopathic PD. Results from the Phase 1 study in healthy volunteers showed target engagement with a >50% increase in glucocerebrosidase (GCase) activity among those receiving clinically relevant doses.

The market opportunity for this mechanism is substantial, with the US Market Potential for GBA1-Parkinson's Disease estimated at $3B and the overall US Parkinson's Disease market potential at $4B.

Accelerated discovery of novel allosteric modulators for difficult-to-drug targets.

The discovery engine is powered by the proprietary Magellan AI platform. This technology has already yielded multiple assets, with patent applications for 5 NCE families (New Chemical Entities) currently under review.

Pipeline expansion potential across multiple lysosomal storage disorders and oncology.

The core GCase modulation platform extends beyond PD. GT-02287 has further potential in Gaucher's disease, dementia with Lewy bodies, and Alzheimer's disease. Also, Gain Therapeutics has multiple undisclosed preclinical assets targeting other areas.

  • Lysosomal Storage Disorders targets include enzymes like GALC and GLB1.
  • Metabolic Diseases targets include AAT.
  • Oncology targets include Solid Tumors with a focus on DDR2.

Here's a quick look at the clinical progress and the financial footing as of the third quarter of 2025:

Metric Value/Status as of Late 2025
GT-02287 Phase 1b Enrollment (as of Sept 30, 2025) 21 participants (surpassed target of 15)
Phase 1b Study Extension Rate Approximately 80% of participants elected to continue for 12 months
Key Data Readout Expected 90-day functional changes and biomarker activity analysis in Q4 2025
GT-02287 Patent Term (Composition of Matter) Through 2038 (excluding extensions)
Cash Position (as of Sept 30, 2025) $8.8 million
Shares Outstanding (as of Nov 2025) 36.0 million
Net Loss (3 months ended Sept 30, 2025) $0.15 per share, basic and diluted

The company is defintely moving forward with its next steps, aiming for an IND Submission in the second half of 2025. Finance: review the burn rate against the $8.8 million cash on hand by next week.

Gain Therapeutics, Inc. (GANX) - Canvas Business Model: Customer Relationships

You're a clinical-stage company, so your most critical relationships revolve around the science and the capital required to prove it. For Gain Therapeutics, Inc., this means intense focus on the investigators running the trials and the investors funding the runway.

High-touch engagement with clinical investigators and trial participants

Engagement here is deep because the Phase 1b study for GT-02287 in Parkinson's disease is the core value driver. The company actively manages these relationships, evidenced by exceeding initial enrollment targets and securing extensions. The commitment from participants is high, which speaks to the perceived value of the trial protocol.

  • Completed enrollment of 21 participants in the Phase 1b study, exceeding the target of 15.
  • Received approval from Australian health authorities to extend treatment duration to a total of 12 months.
  • Approximately 80% of eligible participants elected to transition into the study extension.
  • Initial data showing stabilization/improvement in MDS-UPDRS scores after approximately 30 days was presented in October 2025.

The President and CEO, Gene Mack, expressed deep gratitude to the patients and investigators for their commitment to advancing the program, underscoring the collaborative nature of this relationship.

Direct communication with investors via earnings calls and virtual KOL events

Investor relations is highly event-driven, focusing on translating clinical milestones into digestible financial and scientific updates. The cadence of communication is tied directly to data readouts and financial reporting periods. The company completed an underwritten public offering in Q3 2025, netting approximately $7.1 million in proceeds, which directly impacts the capital relationship.

Key investor and Key Opinion Leader (KOL) touchpoints in late 2025 included:

  • Reporting Q3 2025 financial results on November 12, 2025.
  • Hosting a Virtual KOL Event on October 9, 2025, to discuss initial Phase 1b data.
  • Presenting preclinical data at Neuroscience 2025 on November 20, 2025.
  • Attending the 2025 Maxim Growth Summit on October 16, 2025.

The EPS for the quarter ending September 30, 2025, was reported at negative $0.15, meeting consensus estimates.

Here's a quick look at the recent engagement activity:

Metric/Event Value/Date Context
Q3 2025 EPS -$0.15 Met consensus estimate
Phase 1b Enrollment 21 participants Surpassed target of 15
Study Extension Rate Approx. 80% participation High commitment from subjects
Virtual KOL Event October 9, 2025 Focus on initial GT-02287 data
Cash & Cash Equivalents (Sept 30, 2025) $8.8 million Capital position post-offering

Collaborative relationships with patient advocacy and disease foundations

While specific dollar amounts for foundation partnerships aren't public, the focus on Parkinson's disease necessitates engagement with the patient community to drive awareness and trial recruitment. The company's success in enrolling and retaining participants in the Phase 1b study suggests a functional, if not formally structured, relationship with advocacy networks that support patients seeking novel treatment options.

Business development focus on potential strategic partners (licensing/M&A)

The primary business development driver is the IND submission to the FDA, expected by year-end 2025, which is the gateway to Phase 2 development, including U.S. clinical sites. This milestone is crucial for attracting potential strategic partners for licensing or acquisition, as it de-risks the asset by moving it into a more advanced regulatory pathway. The company's Magellan drug discovery platform, which can screen 5 trillion compounds in less than 3 months, is a key asset for in-licensing or platform-based deals, though no specific deal values were reported as of late 2025.

The next major data readout, the Day-90 functional and biomarker analysis, is expected in Q4 2025, which will be the next key inflection point for business development discussions.

Finance: draft 13-week cash view by Friday.

Gain Therapeutics, Inc. (GANX) - Canvas Business Model: Channels

You're looking at how Gain Therapeutics, Inc. gets its science and its corporate story out to the world-from the clinic to the capital markets. For a clinical-stage company, the channels are all about execution and communication. Here's the quick math on how they are connecting with investigators, the scientific community, and investors as of late 2025.

Clinical Trial Execution and Geographic Reach

The primary channel for validating the lead candidate, GT-02287, is the ongoing Phase 1b clinical trial. This trial is currently centered in Australia, utilizing 7 clinical sites. Enrollment for this study, which evaluates safety and tolerability in Parkinson's disease patients with or without GBA1 mutations, was completed in the third quarter of 2025, reaching 21 participants, exceeding the initial target of 15. The channel for continued patient engagement is the study extension, approved by Australian health authorities, allowing participants to continue treatment for up to a total of 12 months. The planned expansion channel is the anticipated IND submission to the FDA by year end 2025, which is the gateway to initiating Phase 2 development and opening clinical sites in the United States.

The key milestones related to this clinical channel can be mapped out:

  • Phase 1b enrollment completion: Q3 2025.
  • Initial data presentation (MDS conference): October 2025.
  • 90-day analysis expected: Q4 2025.
  • FDA IND submission target: Year end 2025.

Scientific Data Dissemination

To communicate scientific progress, Gain Therapeutics, Inc. uses established industry forums. This is where the data, generated from the Magellan drug discovery platform and the GT-02287 trial, reaches peers and potential collaborators. For instance, preclinical data on GT-02287 was presented at the Society for Neuroscience annual meeting, Neuroscience 2025, held November 15th-19th in San Diego, CA. Furthermore, the company participated in the Drug Discovery Innovation Programme (DDIP) 2025 in Barcelona, Spain, on September 25th - 26th. These events serve as critical touchpoints for scientific validation.

Here is a look at the key scientific communication channels used through late 2025:

Channel/Event Date Location/Focus Data Type
International Congress of Parkinson's Disease and Movement Disorders® October 2025 Honolulu, HI Initial Phase 1b clinical findings
Neuroscience 2025 November 15th-19th, 2025 San Diego, CA Preclinical GT-02287 Data
Drug Discovery Innovation Programme (DDIP) 2025 September 25th - 26th, 2025 Barcelona, Spain AI and Automation in Drug Discovery Talk

Corporate and Financial Disclosure

For the investment community, the channels are formal and regulated. The corporate website is the central hub for public disclosures, offering documents like the Q3 2025 Investor Factsheet and the December 2025 Corporate Presentation. Regulatory filings are the bedrock of financial transparency. The Q3 2025 financial results were released on November 12, 2025. As of September 30, 2025, cash and cash equivalents stood at $8.8 million. To bolster liquidity for future operations, Gain Therapeutics, Inc. filed a shelf registration statement on Form S-3 effective November 26, 2025, allowing for an 'at the market offering' program up to $35,530,980.56. To give you context on the shareholder base, there were 35,976,390 shares outstanding as of September 30, 2025. The company is definitely using these financial channels to manage its runway, stating management expressed substantial doubt about continuing as a going concern beyond the first quarter of 2026 without additional financing.

Partnering and Business Development Outreach

Direct outreach channels focus on securing strategic alliances for the Magellan platform or pipeline assets beyond GT-02287, which has potential in Gaucher's disease, dementia with Lewy bodies, and Alzheimer's disease. A key engagement channel for building scientific credibility with potential industry partners and prescribers is hosting Key Opinion Leader (KOL) events. Gain Therapeutics hosted a virtual KOL event on October 14th, 2025. The platform itself, which integrates AI, physics-based methods, and supercomputing to screen libraries with 5 trillion compounds in less than 3 months, is a core asset being channeled for potential licensing deals.

  • KOL Event Date: October 14, 2025.
  • Platform Capability: Discovery in under 3 months.
  • Pipeline Breadth: GT-02287 plus multiple undisclosed preclinical assets.

Finance: draft 13-week cash view by Friday.

Gain Therapeutics, Inc. (GANX) - Canvas Business Model: Customer Segments

You're looking at the core groups that drive the value for Gain Therapeutics, Inc. (GANX) right now, focusing on the patients they target and the capital providers that fund the journey.

The primary patient segment is centered on neurodegenerative diseases, specifically Parkinson's disease (PD), with a strong focus on the genetic subtype.

  • GT-02287 is being evaluated in a Phase 1b clinical study for PD patients with or without a GBA1 mutation.
  • Enrollment for the Phase 1b study was completed in Q3 2025 with 21 participants, surpassing the initial target of 15 participants.
  • As of September 30, 2025, 16 participants had completed 90 days of dosing.
  • Approximately 80% of eligible participants elected to transition into the study extension.
  • Preclinical models showed a disease-modifying effect in both GBA1-PD and idiopathic PD.

The second patient-facing segment involves rare genetic disorders, which are currently in earlier development stages.

  • GT-02287 has potential for Gaucher's disease, which is a rare lysosomal storage disorder.
  • Gain Therapeutics also has multiple undisclosed preclinical assets targeting lysosomal storage disorders.

For the business development side, large pharmaceutical and biotechnology companies represent a critical segment, as they are potential partners for late-stage development and commercialization.

The company is positioning itself for this segment by hitting key clinical milestones, such as planning to submit an Investigational New Drug (IND) application to the FDA by the end of 2025 to expand Phase 2 development into the United States.

The final segment is the financial community, comprising institutional and individual investors who provide the necessary capital.

Investor Metric Value / Amount
Total Institutional Investors 7
Institutional Ownership Percentage 11.97%
Total Funding Raised (All Rounds) $12.8M
Largest Single Offering (July 2025 Gross Proceeds) Approx. $7.0 million
Cash and Cash Equivalents (as of Sept 30, 2025) $8.8 million
Largest Single Investor Holding (Geode Capital Management LLC) $523K
Analyst Consensus Rating Moderate Buy
Average 1-Year Price Target $7.50

The investor base is actively being engaged through capital raises; for instance, a July 2025 public offering yielded aggregate gross proceeds of approximately $7.0 million. Also, as of late November 2025, Gain Therapeutics filed to offer up to $35,530,980.56 in common stock via an at-the-market offering program. The cash position as of September 30, 2025, stood at $8.8 million.

Gain Therapeutics, Inc. (GANX) - Canvas Business Model: Cost Structure

You're looking at the hard numbers that drive the burn rate for Gain Therapeutics, Inc. as they push GT-02287 through the clinic. The cost structure is almost entirely driven by the science and keeping the lights on for a public company.

High research and development (R&D) expenses for clinical trials and preclinical work are the main cost driver. For the three months ended September 30, 2025, R&D expenses were reported at $2.8 million, up from $2.6 million for the same period in 2024. The increase was primarily due to costs for the ongoing Phase 1b clinical trial and unfavorable foreign exchange currency translation from the strengthening Swiss franc and Australian dollar against the U.S. dollar. This was partially offset by pipeline cost optimization and lower research and development personnel costs.

General and administrative (G&A) costs for corporate overhead and public company compliance also factor in. G&A expenses for the third quarter of 2025 were $1.9 million, an increase of $0.1 million compared to $1.8 million in the third quarter of 2024. These costs include items like legal and professional fees related to general corporate matters, which saw a decrease in the third quarter of 2025 compared to the prior year period.

The bottom line reflects this investment in development. Net loss for the three months ended September 30, 2025, was reported at -$5.3 million. This compares to a net loss of -$0.15 per share, basic and diluted, for the same quarter in 2025. For the nine months ending September 30, 2025, the net loss totaled -$15.6 million.

Personnel costs for specialized scientific and management teams are embedded within the R&D and G&A figures. For instance, the third quarter of 2025 saw lower research and development personnel costs, which helped offset some of the R&D expense increase. The company appointed Gene Mack as President and Chief Executive Officer effective January 6, 2025, with Gianluca Fuggetta assuming the role of Senior Vice President Finance and Principal Financial Officer.

Intellectual property maintenance and patent prosecution fees are a necessary, though often less detailed, component of the operating expenses. While specific line items for these fees aren't explicitly broken out for Q3 2025, they contribute to the overall G&A spend. The company's focus on its Magellan™ drug discovery platform and advancing GT-02287 necessitates ongoing IP protection costs.

Here is a quick look at the operating expense trends for the third quarter:

Metric Q3 2025 Amount (USD) Q3 2024 Amount (USD)
Research and Development (R&D) Expenses $2.8 million $2.6 million
General and Administrative (G&A) Expenses $1.9 million $1.8 million

The cash position also reflects this cost structure. Cash and cash equivalents stood at $8.8 million as of September 30, 2025, down from $10.4 million as of December 31, 2024. The company did see $11.9 million in cash inflows from financing activities over the nine months ending September 30, 2025, to help fund operations.

You can see how the quarterly losses stack up:

  • Net Loss for the three months ended September 30, 2025: -$5.3 million.
  • Net Loss per Share for Q3 2025: ($0.15).
  • Net Loss for the nine months ended September 30, 2025: -$15.6 million.
  • Cash and Cash Equivalents as of September 30, 2025: $8.8 million.
  • Cash and Cash Equivalents as of December 31, 2024: $10.4 million.

For context on earlier 2025 spending, here are the Q1 figures:

  • R&D Expenses for Q1 2025: $2.26 million.
  • G&A Expenses for Q1 2025: $2.11 million.
  • Net Loss for Q1 2025: -$4.53 million.

Finance: draft 13-week cash view by Friday.

Gain Therapeutics, Inc. (GANX) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Gain Therapeutics, Inc. (GANX) as of late 2025, and honestly, it's what you'd expect for a clinical-stage biotech. The focus isn't on current sales, but on securing the capital needed to push the pipeline forward.

Minimal current revenue; consensus Q4 2025 revenue forecast is $0.000.

  • As per analyst ratings, the consensus revenue forecast for 2025Q4 is $0.000.
  • Analyst forecasts indicate that Gain Therapeutics' revenue in 2025 is projected to be $0.
  • Trailing twelve months (ttm) revenue is listed as n/a.

Non-dilutive grant funding from foundations like The Michael J. Fox Foundation.

Gain Therapeutics, Inc. has secured non-dilutive funding, which directly offsets operating expenses like Research & Development (R&D). For instance, R&D expenses decreased in Q1 2025 partly due to research grant income.

  • Funding support has been announced from The Michael J. Fox Foundation for Parkinson's Research (MJFF) and The Silverstein Foundation for Parkinson's with GBA for the GT-02287 program.
  • The company was supported by Innosuisse, the Swiss Innovation Agency, with a grant of CHF 2.5 million (approximately $2.8 million) to develop GT-02287.
  • This funding added to a prior CHF 1.5 million funding received from Innosuisse in 2021.
  • The program also received support from the Eurostars-2 joint program with co-funding from the European Union Horizon 2020 research.

Potential future milestone payments from strategic licensing agreements.

The business model anticipates revenue generation down the line from its proprietary platform and licensed assets. The terms of these arrangements typically outline specific non-cash or cash payments tied to progress.

Revenue Component Type Typical Structure in Biotech Licensing Specific Known Arrangement
Initiation Fee Non-refundable fee upon contract signing. The terms of collaboration and licensing agreements typically include a non-refundable initiation fee.
Milestone Payments Payments upon achieving future development and regulatory goals. Future development and regulatory milestone payments are a typical component.
Royalties Percentage of net sales from a commercialized licensed product. Royalties on net sales of the licensed product are a typical component.

Potential future royalties from commercialized products developed via the platform.

Should any of the pipeline programs, such as the lead candidate GT-02287, reach commercialization, royalties on net sales would become a significant, recurring revenue stream. The Magellan™ platform is used to identify targets for various therapeutic areas.

Equity financing through public offerings (ATM or secondary offerings).

This is the most concrete, near-term source of cash infusion to fund operations, given the lack of product sales. You've seen them execute on this recently to extend the cash runway.

  • In November 2025, Gain Therapeutics, Inc. filed for an At-The-Market (ATM) offering authorization up to $35,530,980.56.
  • As of November 2025, the company had already sold an aggregate of $14,469,019.44 under the original ATM agreement established in September 2024.
  • In July 2025, the company priced an underwritten public offering expecting aggregate gross proceeds of approximately $7.0 million.
  • For the second quarter of 2025, the company highlighted a public offering that raised $7.1 million.

The cash position as of September 30, 2025, was $8.8 million.


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