Innate Pharma Moves Forward with Three Major Clinical Assets as Cash Runway Extends to Q3 2026

Innate Pharma reported its Q3 2025 results with meaningful progress across its clinical portfolio. The biotech company’s latest business update highlights key regulatory wins and on-track timelines for its lead programs, positioning the company for potential value catalysts through 2026.

FDA Green Light for Lacutamab Phase 3—Path to Accelerated Approval Outlined

In a significant regulatory milestone, the FDA completed its review of lacutamab’s confirmatory Phase 3 protocol with no additional comments, clearing Innate Pharma to proceed with the TELLOMAK-3 trial. The study is designed to evaluate the anti-KIR3DL2 antibody in cutaneous T-cell lymphomas, specifically targeting Sézary syndrome and Mycosis fungoides patients who have already received at least one prior systemic therapy.

The randomized trial will run two independent cohorts: patients with Sézary syndrome randomized 1:1 to receive either lacutamab or romidepsin, and Mycosis fungoides patients randomized 1:1 to receive lacutamab or mogamulizumab. The primary endpoint is progression-free survival evaluated by independent central review.

What caught investor attention was the FDA’s encouraging initial feedback on accelerated approval potential for Sézary syndrome. If data supports efficacy during the ongoing Phase 3 study, Innate Pharma could unlock faster market entry. The company plans to initiate TELLOMAK-3 in the first half of 2026, with Phase 2 data already showing durable activity and improved quality of life metrics.

IPH4502 Nectin-4 ADC Reaches Pharmacologically Active Dose

Innate Pharma’s next-generation antibody-drug conjugate, IPH4502, continues enrollment progress in its Phase 1 study across multiple solid tumor types including urothelial carcinoma, non-small cell lung cancer, breast, ovarian, gastric, esophageal, and colorectal cancers. The trial aims to enroll approximately 105 patients total.

The dose-escalation phase has now reached a pharmacologically active dose—a critical milestone indicating the compound is engaging its target at clinically relevant levels. Patient enrollment is progressing well and is expected to wrap by end of 2025 or early Q1 2026, with dose-escalation data anticipated in H1 2026.

Monalizumab PACIFIC-9 Data Expected H2 2026—AstraZeneca Partnership Remains On Track

The Phase 3 PACIFIC-9 trial, run by Innate Pharma’s partner AstraZeneca, is evaluating durvalumab combined with either monalizumab or oleclumab in patients with unresectable Stage III non-small cell lung cancer post-chemoradiation. Enrollment in this trial is now complete, and readouts are expected in the second half of 2026.

Financial Position: €56.4 Million Cash Runway Through Q3 2026

Innate Pharma reported a cash position of €56.4 million as of September 30, 2025, including short-term investments and non-current financial instruments. The company expects this cash runway to support operations through the end of Q3 2026—a critical window as the company awaits multiple clinical data readouts.

Revenues for the first nine months of 2025 came in at €2.3 million, primarily from collaboration agreements with AstraZeneca and Sanofi, down from €10.2 million in the same period of 2024. Financial liabilities totaled €24.8 million as of quarter-end.

Strategic Streamlining and Focus on High-Value Assets

Innate Pharma is concentrating its resources on what management views as the highest-value clinical assets: IPH4502, lacutamab, and monalizumab. As part of this strategic refocus, the company announced planned organizational streamlining including layoffs expected to be completed in H1 2026, subject to French regulatory approval.

The company also maintains an ATM (at-the-market) offering program of up to $75 million in American Depositary Shares, though no sales have been made under this program as of September 30, 2025.

Looking Ahead: 2026 Catalysts in Focus

For Innate Pharma investors, the next 12 months present multiple potential inflection points. The TELLOMAK-3 Phase 3 initiation and potential accelerated approval pathway for lacutamab could reshape the market opportunity. IPH4502 dose-escalation data will provide critical safety and efficacy signals for the Nectin-4 ADC space. And the PACIFIC-9 readout will validate whether monalizumab adds value to the immuno-oncology combination landscape.

CEO Jonathan Dickinson noted that these milestones position the company to “deliver meaningful value for patients and shareholders” as its differentiated portfolio advances through late-stage development.

This page may contain third-party content, which is provided for information purposes only (not representations/warranties) and should not be considered as an endorsement of its views by Gate, nor as financial or professional advice. See Disclaimer for details.
  • Reward
  • Comment
  • Repost
  • Share
Comment
0/400
No comments
  • Pin

Trade Crypto Anywhere Anytime
qrCode
Scan to download Gate App
Community
  • 简体中文
  • English
  • Tiếng Việt
  • 繁體中文
  • Español
  • Русский
  • Français (Afrique)
  • Português (Portugal)
  • Bahasa Indonesia
  • 日本語
  • بالعربية
  • Українська
  • Português (Brasil)