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

You're looking at Applied Therapeutics, Inc., a clinical-stage biotech whose entire model currently balances on getting its lead rare disease drug, govorestat, approved while navigating a tight financial runway. Honestly, as of Q3 2025, that cash position sits at just $11.9 million, which is funding significant Research and Development (R&D) expenses of $9.6 million that quarter, even as they cut staff. The value proposition is clear-transformative treatments for diseases like CMT-SORD-but the key activity is pure regulatory execution and cash management, as evidenced by only $1.0 million in license revenue last quarter. To truly grasp how this company plans to bridge that funding gap and deliver on its CNS-penetrant therapy promise, you need to see the full strategic breakdown below.

Applied Therapeutics, Inc. (APLT) - Canvas Business Model: Key Partnerships

You're looking at the external relationships that fuel Applied Therapeutics, Inc.'s (APLT) development engine as of late 2025. These partnerships are critical because, honestly, a clinical-stage biotech with cash reserves of $11.9 million as of September 30, 2025, needs external validation and funding streams to keep the pipeline moving.

The Key Partnerships block for Applied Therapeutics, Inc. is heavily weighted toward strategic alliances for specific assets and necessary interactions with global health authorities to secure market access for govorestat (AT-007) and AT-001.

Partner/Entity Type	Purpose/Asset	Key Financial/Statistical Data Point	Date/Status Reference
Biossil, Inc.	Out-licensing of AT-001 (Aldose Reductase Inhibitor)	Agreement entered into in July 2025; includes an upfront payment and eligibility for future royalties and milestone payments.	Q2 2025 reporting period.
U.S. Food and Drug Administration (FDA)	Regulatory interaction for Govorestat (CMT-SORD)	Company completed a meeting with the FDA in the third quarter of 2025 to discuss a potential New Drug Application (NDA) submission.	September 29, 2025.
European Medicines Agency (EMA)	Regulatory review for Classic Galactosemia	Marketing Authorization Application (MAA) was validated in December 2023; decision expected in Q1 2025 (based on prior guidance).	Prior guidance from Q3 2024.
Clinical Research Organizations (CROs) / Internal Operations	Clinical Trial Execution (e.g., INSPIRE Trial)	Research and Development expenses for Q3 2025 were $9.6 million, a decrease of $5.2 million from Q3 2024 ($14.8 million).	Q3 2025 data.
Investigator-Initiated Trial (IIT) Sites	Pipeline Expansion (PMM2-CDG)	Results from an ongoing single-patient investigator-initiated trial were presented at the 2025 ASHG Annual Meeting.	October 14-18, 2025.
Potential Strategic Counterparties	Mergers, Acquisitions, Partnerships, or Licensing	Board initiated a process to explore strategic alternatives in November 2025, concurrent with a 46% workforce reduction.	November 20, 2025.

The relationship with Biossil, Inc. for AT-001 is structured to provide non-dilutive funding, though the search results indicate these partnerships have not yet resulted in any meaningful recurring revenue as of the Q2 2025 report.

Regulatory engagement shows a clear focus on CMT-SORD, with the FDA meeting in Q3 2025 to discuss the NDA path, potentially under an accelerated approval pathway. For govorestat, the company holds several key designations:

• Orphan Drug Designation from the FDA for Galactosemia, PMM2-CDG, and CMT-SORD.
• Orphan Medicinal Product Designation from the EMA for Galactosemia and CMT-SORD.
• Rare Pediatric Disease designation for Galactosemia and PMM2-CDG.
• Fast Track designation for Galactosemia.

Regarding trial execution, the decrease in R&D expenses suggests cost management, with Q2 2025 R&D expenses at $9.9 million, down about $0.1 million from Q2 2024 ($10.0 million), primarily due to a decrease in clinical and preclinical expenses. The overall biotech CRO market is large, projected to surpass $100 billion by 2028, but Applied Therapeutics, Inc. appears to be managing its external trial costs carefully relative to prior periods.

The pipeline expansion via IITs is significant for PMM2-CDG, where new data was published in JIMD and presented at the 2025 ASHG Annual Meeting in October 2025. This non-traditional trial structure helps expand the data set without the full cost burden of a company-sponsored Phase 3 trial, which can cost in the range of $20-$100+ million for a large-scale study.

The exploration of strategic alternatives in November 2025 is the most direct signal of seeking a major partnership or acquisition, aiming to maximize shareholder value while preserving cash runway, which stood at $30.4 million at the end of Q2 2025.

Finance: draft 13-week cash view by Friday.

Applied Therapeutics, Inc. (APLT) - Canvas Business Model: Key Activities

Clinical development of govorestat for rare metabolic diseases involves advancing data across several indications.

• For Charcot-Marie-Tooth Sorbitol Dehydrogenase Deficiency (CMT-SORD), 24-month data from the INSPIRE Phase 3 trial was presented at the Peripheral Nerve Society (PNS) 2025 Annual Meeting.
• In a preclinical CMT-SORD model, govorestat achieved a 37 percent sorbitol reduction in the sciatic nerve.
• For phosphomannomutase 2-congenital disorder glycosylation (PMM2-CDG), single-patient data was shared at the 2025 ASHG Annual Meeting (October 14-18, 2025).
• The PMM2-CDG single-patient case showed the Nijmegen Pediatric CDG Rating Scale (NPCRS) improved by 9 points (46 percent).
• For Classic Galactosemia, the company has an FDA meeting scheduled in 4Q 2025 following the November 2024 Complete Response Letter.

Regulatory engagement to support New Drug Application (NDA) submission for CMT-SORD centered on key interactions with the U.S. Food and Drug Administration (FDA).

• Applied Therapeutics, Inc. completed a meeting with the FDA in the third quarter of 2025 (announced September 29, 2025) to discuss the potential NDA submission strategy.
• The company is awaiting official meeting minutes to determine next steps, as a path forward has not yet been determined.
• FDA Type C meeting minutes received in Q3 2025 identified open issues, including the surrogate endpoint, primary endpoint, and carcinogenicity testing.
• The company intends to request another Type C meeting to discuss the Phase 3 design.
• A potential NDA submission for CMT-SORD was expected in 2025.

Research and Development (R&D) activities reflect ongoing pipeline work and strategic divestitures.

Metric	Q3 2025 (3 Months Ended Sept 30)	Q1 2025 (3 Months Ended Mar 31)
Research and Development Expense (USD Millions)	$9.6 million	$7.8 million
General and Administrative Expense (USD Millions)	$8.2 million	$17.7 million

The R&D expense decrease from Q1 2025 to Q3 2025 of $1.8 million was primarily related to a decrease in clinical and preclinical expenses, stock-based compensation, and regulatory expenses, offset by an overall increase in personnel, drug manufacturing and formulation expenses in Q3 2025 compared to Q1 2025 R&D drivers.

The company also executed on its portfolio by entering into an out-licensing agreement with Biossil, Inc. for AT-001, an investigational Aldose Reductase Inhibitor (ARI) for Diabetic Cardiomyopathy.

Strategic review to optimize cash and explore financing options is critical given the cash burn rate.

Financial Metric	September 30, 2025	March 31, 2025	December 31, 2024
Cash and Cash Equivalents (USD Millions)	$11.9 million	$50.8 million	$79.4 million
Net Loss (USD Millions)	$19.0 million	$21.8 million	N/A
Net Loss Per Share (USD)	($0.13)	($0.15)	N/A

The cash position declined by $67.5 million from December 31, 2024, to September 30, 2025.

Drug manufacturing and formulation for clinical supply is an ongoing component of R&D spending.

• Drug manufacturing and formulation expenses contributed to an overall increase in R&D expenses in Q1 2025 compared to Q1 2024.
• Drug manufacturing and formulation expenses contributed to an overall increase in R&D expenses in Q3 2025 compared to Q3 2024.

Finance: draft 13-week cash view by Friday.

Applied Therapeutics, Inc. (APLT) - Canvas Business Model: Key Resources

The Key Resources for Applied Therapeutics, Inc. center on its lead investigational asset, intellectual property protections, and current financial standing as of late 2025.

Govorestat, the lead CNS-penetrant Aldose Reductase Inhibitor, is central to the business model, targeting rare metabolic diseases.

• Govorestat is being developed for Charcot-Marie-Tooth Sorbitol Dehydrogenase Deficiency (CMT-SORD) and Classic Galactosemia.
• Govorestat is a novel central nervous system (CNS) penetrant Aldose Reductase Inhibitor (ARI).

The clinical trial data for the Phase III INSPIRE trial of govorestat in CMT-SORD provides concrete evidence of its mechanism and effect:

• Govorestat remained safe and well tolerated through 24 months of treatment.
• Sustained reductions in blood sorbitol levels were observed out to 24 months.
• MRI measurements of the muscle-fat fraction in the lower limbs showed significant differences at 24-months, suggesting a slowing of disease progression.
• A statistically significant improvement in the CMT-Health Index (CMT-HI), a patient-reported outcome, was noted.
• In a preclinical CMT-SORD model, govorestat reduced sorbitol levels in the sciatic nerve by 37 percent.
• The 10-meter walk-run test, which served as a primary endpoint, was not statistically significant between govorestat-treated and placebo-treated groups.

Intellectual property, particularly regulatory designations, secures market exclusivity for govorestat in its target indications:

Designation Type Indication(s) Issuing Body Orphan Drug Designation (ODD) Galactosemia, phosphomannomutase 2 deficiency (PMM2-CDG), and CMT-SORD U.S. Food and Drug Administration (FDA) Orphan Drug Designation (ODD) Galactosemia and CMT-SORD European Medicines Agency (EMA) Rare Pediatric Disease designation Galactosemia and PMM2-CDG FDA Fast Track designation Galactosemia FDA

Financial resources are a critical, time-sensitive resource as of the latest reporting period. The cash position reflects the ongoing investment in clinical and regulatory execution.

The balance sheet as of September 30, 2025, shows the following:

Financial Metric	Amount as of September 30, 2025
Cash and cash equivalents	$11.9 million
Cash and cash equivalents (vs. December 31, 2024)	$79.4 million
Cash and cash equivalents (vs. June 30, 2025)	$30.4 million

The company relies on its specialized personnel in rare disease drug development to navigate complex regulatory pathways, including constructive discussions with the FDA in the third quarter of 2025 regarding a potential New Drug Application (NDA) submission strategy for govorestat in CMT-SORD.

• The company completed a meeting with the FDA in the third quarter of 2025 to discuss the potential NDA submission for govorestat for CMT-SORD.
• The company intends to request an additional Type C meeting with the FDA to further discuss a potential Phase 3 trial design for CMT-SORD.

Applied Therapeutics, Inc. (APLT) - Canvas Business Model: Value Propositions

Transformative treatments for diseases with high unmet need. Applied Therapeutics, Inc. is dedicated to creating transformative treatments for rare diseases, such as Charcot-Marie-Tooth Sorbitol Dehydrogenase Deficiency (CMT-SORD), Classic Galactosemia, and PMM2-Congenital Disorder of Glycosylation (PMM2-CDG).

Govorestat slowing disease progression in CMT-SORD patients. Full 12-month clinical results and new topline data from 18 and 24 months from the INSPIRE Phase 2/3 trial were presented at the Peripheral Nerve Society 2025 Annual Meeting.

Clinical Measure (Govorestat vs. Placebo)	Time Point	Result Metric	Data Point
Sorbitol Reduction (Sciatic Nerve, Rats)	N/A	Reduction Percentage (p-value)	37% (p=0.005)
Blood Sorbitol Levels	Sustained	Trend	Sustained reductions through 24 months
Disease Progression (MRI)	24 months	Observation	Slowing of progression observed
CMT-Health Index (CMT-HI)	12 months	Statistical Significance	Statistically significant improvement
10-Meter Walk-Run Test (10MWRT)	12 months	Statistical Significance	Not statistically significant

CNS-penetrant drug targeting central nervous system metabolic disorders. Govorestat is a novel central nervous system (CNS) penetrant Aldose Reductase Inhibitor (ARI).

No-cost sorbitol assay to remove barriers to CMT-SORD diagnosis. The company's focus includes addressing diagnostic barriers for CMT-SORD, where sorbitol accumulation is central to the pathology.

Potential first-in-class therapy for Classic Galactosemia. Applied Therapeutics, Inc. is scheduled to meet with the FDA in the fourth quarter of 2025 to review govorestat for Classic Galactosemia. The program remains under a Complete Response Letter (CRL).

Additional value proposition data points include:

• Cash and cash equivalents as of September 30, 2025: $11.9 million.
• Q3 2025 Net Loss: $18.99 million, compared to $68.59 million a year ago.
• Q3 2025 Revenue: $1 million.
• PMM2-CDG single-patient data showed NPCRS improved by 9 points, which is 46%.

Applied Therapeutics, Inc. (APLT) - Canvas Business Model: Customer Relationships

Applied Therapeutics, Inc. focuses its customer relationships on key stakeholders necessary for advancing its rare disease pipeline, particularly govorestat.

Patient advocacy and government affairs outreach

The internal structure dedicated to this segment saw a key personnel change in mid-2025, indicating a focus on this relationship area.

• Dottie Caplan was promoted to Executive Vice President, Patient Advocacy and Government Affairs on June 17, 2025.

Direct engagement with rare disease patient communities

Engagement is demonstrated through scientific dissemination relevant to patient groups suffering from the target rare metabolic diseases, including Charcot-Marie-Tooth Sorbitol Dehydrogenase Deficiency (CMT-SORD), Classic Galactosemia, and phosphomannomutase 2 congenital disorder of glycosylation (PMM2-CDG).

• Results for govorestat in PMM2-CDG were presented at the 2025 American Society of Human Genetics (ASHG) Annual Meeting, held October 14-18, 2025.
• Full 12-month clinical results and new topline 18- and 24-month data from the INSPIRE Phase 2/3 trial for CMT-SORD were presented at the Peripheral Nerve Society (PNS) 2025 Annual Meeting in May 2025.

High-touch support for healthcare providers (HCPs) on diagnosis

Applied Therapeutics, Inc. initiated a direct support program to help HCPs identify patients for one of its key indications.

• In July 2025, the Company launched a sponsored Urine Sorbitol Assay for the identification of patients with CMT-SORD.
• This assay is available to healthcare providers at no cost for patients and caregivers.

Regulatory dialogue with the FDA for development alignment

The relationship with the U.S. Food and Drug Administration (FDA) is central to advancing govorestat through clinical development and towards potential marketing authorization for both CMT-SORD and Classic Galactosemia.

Regulatory Event/Milestone	Indication	Timing/Status (Late 2025)
Type C Meeting Minutes Received	CMT-SORD	Received in Q3 2025, following a Q3 2025 meeting to discuss potential New Drug Application (NDA) requirements.
FDA Meeting Scheduled	Classic Galactosemia	Scheduled for the fourth quarter (4Q) of 2025.
New Meeting Request Planned	CMT-SORD	Plans to submit another request to further discuss the design of a potential Phase 3 trial.

The Company completed a meeting with the FDA in the third quarter of 2025 regarding govorestat for CMT-SORD.

Investor relations for capital market communication

Communication with the capital markets reflects the ongoing clinical development costs and the need for future funding, especially following a strategic review announcement in November 2025.

Financial Metric/Event	Amount/Value	Date/Period
Cash and Cash Equivalents	$11.9 million	As of September 30, 2025
Revenue (GAAP)	$1.0 million	Q3 2025
Net Loss	$18.99 million	Q3 2025
Net Loss Per Share	$(0.13)	Q3 2025
Cash Used in Operations	$67.4 million	Nine months ended September 30, 2025
Accumulated Deficit	$636.4 million	As of September 30, 2025
Workforce Reduction	Approximately 46%	Expected to be substantially complete by the end of the quarter ending December 31, 2025

Applied Therapeutics, Inc. announced a broad review of strategic alternatives, which may include potential business combinations, on November 20, 2025. The stock traded on NASDAQ under the ticker APLT, with a reported price of $0.23 at one point in late 2025.

Applied Therapeutics, Inc. (APLT) - Canvas Business Model: Channels

You're looking at how Applied Therapeutics, Inc. moves its clinical progress and potential products toward the market, which is all about regulatory clearance and getting the science out there. For a clinical-stage company focused on rare diseases, the channels are heavily weighted toward scientific communication and regulatory bodies right now, rather than broad commercial sales forces.

Regulatory Submissions (NDA/MAA) to the FDA and EMA

The primary channel for product approval is direct engagement with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). For govorestat (AT-007) in Classic Galactosemia, the New Drug Application (NDA) was submitted to the FDA in December 2023, and the Marketing Authorization Application (MAA) was validated by the EMA in December 2023. Following a Complete Response Letter (CRL) in November 2024, the Company completed a meeting with the FDA on September 29, 2025, to discuss the regulatory path forward. For Charcot-Marie-Tooth Sorbitol Dehydrogenase (CMT-SORD) Deficiency, Applied Therapeutics, Inc. completed a meeting with the FDA in the third quarter of 2025 to discuss the potential NDA submission strategy. The FDA provided constructive feedback on the data requirements needed to support a potential future NDA submission. A follow-up meeting with the FDA regarding the regulatory path for Classic Galactosemia is expected in the fourth quarter of 2025.

Clinical Trial Sites and Specialized Metabolic Centers

Clinical sites serve as the initial channel for data generation and patient access, especially for rare diseases. The Company is advancing govorestat for phosphomannomutase 2-congenital disorder glycosylation (PMM2-CDG) through an ongoing single-patient investigator-initiated trial. To support diagnosis and access for CMT-SORD, Applied Therapeutics, Inc. launched a sponsored Urine Sorbitol Assay in July 2025, which is available to healthcare providers at no cost for patients. The patient populations targeted by the pipeline candidates define the necessary centers of expertise:

• CMT-SORD affects approximately 3,300 patients in the U.S. and 4,000 in the EU.
• Classic Galactosemia affects over 3,000 patients in the United States.

Out-licensing Partners (e.g., Biossil) for Commercialization

For certain indications, out-licensing acts as the immediate commercialization channel, bringing in non-dilutive cash flow. In July 2025, Applied Therapeutics, Inc. entered an out-licensing agreement with Biossil, Inc. for AT-001, the investigational therapy for Diabetic Cardiomyopathy (DbCM). This deal provided an upfront payment of $1.0 million. This is separate from a prior agreement with Advanz Pharma, which included an upfront payment of EUR 10.0M (around $10.7M) and potential milestones up to EUR 134M. These partnerships are key for funding, though they do not cover the core rare disease franchises like CMT-SORD.

Scientific Publications and Conference Presentations (PNS, ASHG)

Dissemination of clinical data through peer-reviewed publications and major medical conferences is a critical channel for establishing scientific credibility and informing future regulatory strategy. Applied Therapeutics, Inc. presented full 12-month, topline 18-month, and 24-month data from the INSPIRE Phase 2/3 trial for CMT-SORD at the Peripheral Nerve Society (PNS) 2025 Annual Meeting in May 2025. The oral presentation was assigned number 597. Furthermore, results from the single-patient trial evaluating govorestat for PMM2-CDG were published in the Journal of Inherited Metabolic Disease (JIMD) and presented at the 2025 ASHG Annual Meeting in October 2025.

Specialty Pharmacies and Distribution Networks (future)

While full commercial distribution channels are likely future considerations pending regulatory approvals for the lead assets, the Company is already engaging with the infrastructure needed for patient support. The launch of the no-cost sponsored Urine Sorbitol Assay supports healthcare providers in identifying suspected CMT-SORD cases, which is a precursor to treatment distribution. The financial reality underpinning these channel activities shows a significant cash burn rate:

Financial Metric (as of Q2 2025 End)	Amount
Cash and Cash Equivalents (June 30, 2025)	$30.4 million
Cash and Cash Equivalents (September 30, 2025)	$11.9 million
R&D Expense (Q2 2025)	$9.9 million
General and Administrative Expense (Q2 2025)	$13.2 million
Net Loss (Six Months Ended June 30, 2025)	$43.2 million

The decrease in cash from $79.4 million at the end of 2024 to $11.9 million by September 30, 2025, highlights the reliance on non-dilutive funding from licensing deals to bridge the gap until potential product revenue.

Finance: draft 13-week cash view by Friday.

Applied Therapeutics, Inc. (APLT) - Canvas Business Model: Customer Segments

You're looking at the core groups Applied Therapeutics, Inc. (APLT) targets with its lead candidate, govorestat. These are specific, small patient pools, which is typical for a company focused on rare metabolic diseases. Honestly, the financial reality of late 2025 shows this focus is expensive; Q3 2025 revenue was only $1 million, against a net loss of $18.99 million, leaving cash and cash equivalents at just $11.9 million as of September 30, 2025. This means every patient interaction and potential partnership is critical.

The primary customer segments are defined by the rare diseases govorestat is designed to treat:

• Patients with CMT-SORD (Charcot-Marie-Tooth Sorbitol Dehydrogenase Deficiency).
• Patients with Classic Galactosemia (pediatric and adult).
• Patients with PMM2-CDG (Congenital Disorder of Glycosylation).

Here's a breakdown of the estimated patient populations for the core indications, which directly informs the size of these segments:

Indication	Estimated US Patients	Estimated EU Patients
CMT-SORD	3,300	4,000
Classic Galactosemia	Approximately 3,000	Approximately 4,000

For Patients with CMT-SORD, the focus is on those in the ongoing INSPIRE Phase III trial; 90% of remaining INSPIRE patients (45 out of 50) are continuing on govorestat in the open-label extension, showing strong patient commitment to the treatment. The clinical rationale is strong, with preclinical models showing a 37 percent reduction of sorbitol in the sciatic nerve with govorestat.

For Patients with Classic Galactosemia, the segment is defined by the need for a treatment following the FDA's Complete Response Letter in late 2024. The company is scheduled to meet with the FDA in Q4 2025 to discuss the path forward. This patient group, including pediatric and adult populations, is identified rapidly due to mandatory newborn screening in the US and most EU countries.

The segment for Patients with PMM2-CDG is characterized by high unmet need, as it is a severe, rare disease with high mortality in pediatrics. Data from a single-patient trial showed a significant clinical improvement, with the Nijmegen Pediatric CDG Rating Scale (NPCRS) improving by 9 points (46%) over the treatment course.

Beyond the patients themselves, Applied Therapeutics, Inc. (APLT) targets professional intermediaries and potential partners:

• Specialist physicians (neurologists, metabolic disease specialists).
• Biopharmaceutical companies seeking to license assets.

The segment of Specialist physicians is small, given the ultra-rare nature of the diseases, but critical for diagnosis, trial recruitment, and future prescription volume. The company has made key leadership promotions, including Dottie Caplan to Executive Vice President, Patient Advocacy and Government Affairs, to strengthen these community and professional relationships.

The segment of Biopharmaceutical companies seeking to license assets is a financial necessity given the current burn rate; the Q3 2025 basic loss per share from continuing operations was $0.13. This segment represents a non-dilutive funding opportunity, as seen by the out-licensing agreement for AT-001 to Biossil, Inc..

Applied Therapeutics, Inc. (APLT) - Canvas Business Model: Cost Structure

The cost structure for Applied Therapeutics, Inc. (APLT) as of late 2025 is heavily weighted toward Research and Development and General and Administrative functions, reflecting its clinical-stage biopharmaceutical focus with no product sales or recurring revenue streams recognized in Q3 2025.

Key operating expenses for the third quarter ended September 30, 2025, are detailed below, showing a significant reduction compared to the prior year period.

Cost Category	Q3 2025 Amount (USD)	Q3 2024 Amount (USD)
Research and Development Expenses	$9.6 million	$14.8 million
General and Administrative Expenses	$8.2 million	$15.0 million
Net Loss	$18.99 million	$68.59 million

The decrease in Research and Development expenses from Q3 2024 to Q3 2025 was approximately $5.2 million. This reduction was primarily driven by lower clinical and preclinical expenses, stock-based compensation, and regulatory and other expenses. However, this decrease was partially offset by an overall increase in personnel, drug manufacturing and formulation expenses within R&D.

Personnel costs are a major component of the overall cost base, leading to significant restructuring. Applied Therapeutics, Inc. initiated cost-containment measures including a major workforce reduction.

• Workforce cut: approximately 46%.
• The reduction is expected to be substantially completed by the end of the quarter ending December 31, 2025.
• Applied Therapeutics, Inc. entered 2025 with 35 full-time employees.
• Of those, 18 employees were primarily engaged in Research and Development activities.

Legal and professional fees for regulatory and corporate matters are a significant driver of G&A costs. For instance, G&A expenses in Q2 2025 rose compared to Q2 2024 due to higher legal, professional, and personnel expenses. Furthermore, the decrease in G&A from Q3 2024 to Q3 2025 was primarily related to an increase in legal and litigation settlement expenses being offset by other factors.

Clinical trial expenses and drug manufacturing costs are embedded within the R&D spend. An overall increase in drug manufacturing and formulation expenses was noted as an offset to the R&D expense decrease between Q3 2024 and Q3 2025.

The company's cash position as of September 30, 2025, stood at $11.9 million, a reduction from $79.4 million at December 31, 2024, underscoring the necessity of the cost-containment measures.

Applied Therapeutics, Inc. (APLT) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Applied Therapeutics, Inc. (APLT) as of late 2025. For a clinical-stage biopharma, revenue is often lumpy, tied to deals and milestones rather than consistent product sales, and that's exactly what the latest numbers show.

License revenue from out-licensing agreements is the most concrete recent income source. For the third quarter ended September 30, 2025, Applied Therapeutics, Inc. reported total revenue of $1.00 million. This was a significant jump from the $0.122 million reported in the same quarter of the prior year. The entire $1.0 million recognized in Q3 2025 was explicitly driven by license revenue from its Biossil Agreement. To be fair, Q2 2025 showed zero GAAP revenue, so this is clearly deal-dependent.

The structure of this revenue stream can be broken down:

• License revenue from out-licensing agreements: $1.0 million in Q3 2025.
• Revenue for the nine months ended September 30, 2025: $1.0 million.
• Revenue for the nine months ended September 30, 2024: $0.455 million.

Here's a quick look at how the recent quarterly revenue compares:

Period Ending	Reported Revenue (USD)	Year-over-Year Change
September 30, 2025 (Q3 2025)	$1.00 million	Up 719.67% from Q3 2024's $122.00 thousand
June 30, 2025 (Q2 2025)	Zero (GAAP)	Down from $0.14 million (GAAP) in Q2 2024
December 31, 2024 (Fiscal Year)	$455.00 thousand	-95.45% decrease from Fiscal Year 2023

Upfront and milestone payments from partnerships are embedded within that license revenue. The $1.0 million in Q3 2025 is directly attributed to the Biossil Agreement, which suggests it was either an upfront payment or a specific milestone achievement recognized during that quarter. Applied Therapeutics, Inc. also entered into an out-licensing agreement with Biossil, Inc. for AT-001 during Q2 2025.

Future royalties on commercialized out-licensed products are a potential stream, but the public filings don't detail the specific percentage or structure of these future payments tied to the AT-001 license, or any other potential deals.

Future product sales of govorestat post-approval are currently minimal/zero, as expected for a company awaiting regulatory decisions. The consensus estimate for Applied Therapeutics, Inc.'s revenue in the next reported quarter is $0.00 USD. The company continues to advance govorestat for CMT-SORD and is reviewing the development program for Classic Galactosemia.

Equity financing or debt to fund operations is reflected in the cash position, which is critical for funding the ongoing Research and Development expenses, which were $9.6 million for the three months ended September 30, 2025. You need to watch the cash burn; cash and cash equivalents stood at $11.9 million as of September 30, 2025, down significantly from $79.4 million at December 31, 2024. This cash level suggests the need to secure additional capital or partnerships to maintain operations through 2026, pending regulatory milestones.

Finance: draft 13-week cash view by Friday.