Werewolf Reports No Revenue in Fiscal Q2

Key Points

• GAAP EPS loss of $0.468 in Q2 2025 matched estimates and

• No revenue was reported, a decrease compared to the second quarter of 2024, a decrease from $1.143 million in GAAP collaboration revenue in the prior-year period and in line with expectations.

• Research and development expenses declined 14.4% compared to the prior-year period, and cash runway extends into the fourth quarter of 2026.

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Werewolf Therapeutics (NASDAQ:HOWL), an early-stage biotechnology company dedicated to innovative cancer immunotherapies, reported its second quarter 2025 results on August 14, 2025. The main story this period: it continues to invest heavily in research while awaiting critical clinical milestones, with GAAP EPS loss was $0.40 and no revenue, mirroring consensus forecasts. While commercial activity was muted, Research and development and general and administrative expenses declined compared to the same period in 2024, along with setting the tone for the remainder of fiscal 2025. Net loss (GAAP) was $18.0 million, compared to $17.2 million for the same period in 2024. The quarter showed stable execution, but all eyes are on late 2025 clinical and regulatory events.

Source: Analyst estimates for the quarter provided by FactSet.

About Werewolf Therapeutics and Its Focus

Werewolf Therapeutics is a biopharmaceutical company specializing in cancer immunotherapy. It is focused on creating conditionally activated biology, using a proprietary PREDATOR platform to craft treatments that target tumors while sparing healthy tissue. The company is primarily engaged in the development of next-generation cytokine therapies and T-cell engaging drugs designed for improved safety and effectiveness.

The business remains in its clinical development stage, meaning it does not yet market approved drugs or generate commercial revenue. Success depends on clinical trial results, regulatory interactions, careful management of research and administrative spending, and the ability to secure strategic partnerships during this long research period. It is currently pushing two lead assets—WTX-124 and WTX-330—forward in clinical trials, while newer molecules such as WTX-1011 provide future growth opportunities.

Quarter in Review: Pipeline Progress, Spending, and Operations

The most visible development was the continued clinical advancement of WTX-124 and WTX-330. WTX-124 is an IL-2 INDUKINE molecule—this means it is a modified cytokine drug designed to enhance immune system attack specifically within the tumor microenvironment, tested in several types of solid tumors. Settling on a recommended 18 mg intravenous dose every two weeks, it remains on track for a critical interim clinical data release in the fourth quarter of 2025. This update will focus on key clinical endpoints like patient tolerability, response rates, and how long responses last, particularly in melanoma and kidney cancer patients. Werewolf plans regulatory discussions with the United States Food and Drug Administration (FDA) later in 2025 for potential registration studies, a pivotal step toward eventual commercialization.

WTX-330, an IL-12 INDUKINE molecule also engineered for targeted immune stimulation, is enrolling in an early-stage (Phase 1b/2) trial. Management expects to set the dosing strategy by the end of 2025. No new clinical data from these programs were released this quarter, and financial plans for moving either drug into later-phase trials remain dependent on the strength of forthcoming results and regulatory feedback.

New platform innovation was reported in preclinical programs, especially WTX-1011. This product is an anti-STEAP1 T-cell engager for prostate cancer, aiming to drive immune system T cells directly against tumor cells using the company’s INDUCER technology. Data showed WTX-1011 achieves low systemic activity, potentially reducing side effects—less than 0.7% of active agent is detectable in circulation—and limits unwanted immune signaling outside tumors. The next pipeline milestone is expected in the second half of the year, with the nomination of an additional INDUCER candidate.

From a financial view, Research and development spending dropped 14.4% to $13.1 million (GAAP) compared to the same period in 2024. General and administrative costs fell modestly as well. The company ended the quarter with a $77.6 million cash position, down from $92.0 million as of March 31, 2025, while stating this cash should last into the fourth quarter of 2026. Werewolf reported no new partnership or collaboration revenue, and the prior-year period's $1.1 million in collaboration revenue was not repeated. The strategic focus now includes seeking additional partners, especially for early-stage pipeline assets that are available for out-licensing.

Looking Ahead: Financial Guidance and Investor Focus Points

Management reiterated that cash and cash equivalents as of June 30, 2025, should finance the business through the fourth quarter of 2026, assuming spending rates remain steady and no unexpected major costs arise. No specific forecasts for revenue, product approvals, or profitability were provided, which is typical at this research phase. Investors should watch for the critical interim results from WTX-124 in late 2025 and the planned FDA meetings as major upcoming events.

HOWL does not currently pay a dividend.

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

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