Applied Therapeutics Reports Q2 Loss

Applied Therapeutics (APLT 2.61%), a biotechnology company focused on developing treatments for rare metabolic diseases, reported earnings results for Q2 2025 on August 13, 2025. The main news from the release was the absence of recurring revenue and the continuation of operating losses, even as reported GAAP headline earnings per share outperformed analyst expectations. The company reported an EPS (GAAP) of $(0.15), GAAP earnings per share of $0.15 was greater than the estimated loss of $(0.17), but recognized $21.33 million in GAAP revenue, exceeding the $0.42 million GAAP forecast. Cash and cash equivalents (GAAP) dropped from $79.4 million as of December 31, 2024, to $30.4 million as of June 30, 2025, intensifying concerns over the firm’s financial sustainability in coming quarters. Overall, the period underscored progress in clinical programs but reinforced the urgent need for new capital or partnerships as losses mount.

Source: Analyst estimates for the quarter provided by FactSet.

Business Overview and Recent Focus

Applied Therapeutics is dedicated to developing therapies for rare metabolic diseases where few treatment options exist. Its most advanced candidates target inherited metabolic disorders including classic galactosemia, SORD deficiency (also known as CMT-SORD), and PMM2-CDG.

Recently, the business has centered its efforts on winning regulatory approval for govorestat, a small molecule drug for CMT-SORD, and pushing forward with clinical research across its pipeline. Key success factors for the company include producing compelling clinical data showing efficacy and safety, securing regulatory milestones such as New Drug Application (NDA) submission, and forming commercial partnerships to support future market launches. Navigating regulatory hurdles and demonstrating clinical value are especially crucial, given that none of its therapies have yet progressed to commercialization.

Quarterly Highlights and Notable Developments

The quarter saw continuation of net losses. There were no product sales or recurring revenue streams, as the company has not yet launched any commercial therapies. Revenue (GAAP) was zero.

General and administrative expenses increased, while research and development expenses decreased slightly year-over-year, particularly on the administrative side. General and administrative expenses rose 24.5%, reaching $13.2 million compared to Q2 2024. This increase was attributed by management to higher legal, professional, and personnel expenses, coupled with greater costs for data storage and stock-based compensation. Research and development spending edged down 1.0% to $9.9 million, reflecting a mix of decreasing clinical costs but higher expenses in travel, consulting, and drug manufacturing. The decline in research costs was partly offset by greater stock-based compensation.

The company’s net loss (GAAP) came to $21.3 million, compared to a net loss of $0.13 per diluted share (GAAP) in Q2 2024. This negative result highlights continued cash burn and no offsetting top-line income. The change in fair value of warrant liabilities was $1,437,000, compared to $22,744,000 in Q2 2024. This change contributed to the year-over-year shift in net results.

On the clinical front, Applied Therapeutics advanced three product programs. The lead candidate, govorestat, is a small molecule drug for SORD Deficiency (CMT-SORD), a rare hereditary nerve disorder. The INSPIRE Phase 2/3 study continued to produce positive data, with statistically significant improvements on important health and functional measures over 12 months in the INSPIRE Phase 2/3 trial of govorestat for CMT-SORD. Specifically, improvements were noted in the CMT Health Index and lower limb function, and the therapy slowed disease progression over 24 months. Regulatory progress was also apparent: a meeting with the FDA is scheduled in the next quarter for NDA planning. For classic galactosemia, also a rare inherited disorder, the program remains in limbo following the issue of a Complete Response Letter (CRL) by the FDA earlier this year; management is still determining next steps. Meanwhile, for PMM2-CDG, a metabolic disorder affecting glycosylation, clinical data will be presented at a scientific meeting in October 2025. None of these programs have yet reached commercialization, but each is critical to the company’s longer-term revenue potential.

Outside the clinic, Applied Therapeutics entered a new partnership by out-licensing AT-001, a therapy for diabetic cardiomyopathy, to Biossil, Inc. in July 2025. This agreement produced some near-term cash, with the potential for future milestone payments and royalties, but does not include core rare disease franchises. While these partnerships may provide a future non-dilutive funding stream, they have not yet resulted in any meaningful recurring revenue. There was no dividend declared and Applied Therapeutics does not currently pay a dividend.

Looking Ahead and Management Outlook

For the rest of 2025, management's key objectives include advancing regulatory filings for govorestat in CMT-SORD and resuming dialogue with the Food and Drug Administration (FDA) for classic galactosemia. A meeting with the FDA regarding govorestat’s NDA submission is scheduled for next quarter. The company also points to the upcoming data presentation on PMM2-CDG as another clinical catalyst. However, in the company’s release, no specific forward financial guidance or revenue forecast was provided for the upcoming quarters or the full year.

Investors should focus on upcoming regulatory decisions and the ability of partnerships to potentially convert into realized revenue or additional non-dilutive funding. Financial sustainability is a growing concern, as the company’s cash and cash equivalents (GAAP) declined from $79.4 million as of December 31, 2024, to $30.4 million as of June 30, 2025. Management will likely need to secure more funding or additional partnerships in the next year to maintain operations and support ongoing clinical trials. APLT does not currently pay a dividend.

Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted.