Primary-source record
Decision-gradeOther
HOWL/Ambros announce merger + $150M placement to fund neridronate Phase 3
Werewolf Therapeutics and Ambros Therapeutics signed a definitive all-stock merger agreement that will create a Nasdaq-listed entity focused on neridronate for CRPS-1. A concurrent oversubscribed $150 million private placement will fund the ongoing pivotal CRPS-RISE Phase 3 trial through topline readout in 2028 and planned NDA submission, with cash runway into 1H 2029.
Key facts
- Filed
- Aug 21, 2026, 01:10 PM
- Event
- Other
- Direction
- Positive
- Company
HOWLWerewolf Therapeutics- Asset
- neridronate
- Source
- SEC 8-K
- Confidence
- Sourced
- cash runway
- 1H 2029
- NDA submission
- planned
- topline expected
- 2028
- private placement
- 150 million
- market exclusivity
- 2045
- phase 3 participants
- 270
- newly diagnosed us patients
- 65000
Source excerpt
EX-99.1 11 d102535dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Werewolf Therapeutics and Ambros Therapeutics Announce Merger Agreement and Concurrent Oversubscribed $150 million Private Placement • Proposed merger to create a Nasdaq-listed, late-stage biotechnology company advancing neridronate, a potential first FDA-approved treatment for CRPS-1, a debilitating orphan disease with 65,000 newly diagnosed U.S. patients annually and no currently FDA-approved therapy • Pivotal CRPS-RISE Phase 3 trial evaluating neridronate remains ongoing, with FDA Breakthrough Therapy, Fast Track and Orphan Drug designations received and alignment with FDA that a single successful pivotal trial could potentially support approval • Neridronate has been administered to approximately 600,000 patients in Italy across approved indications including CRPS-1 • Concurrent oversubscribed private placement of $150 million from a syndicate of leading healthcare-dedicated investors expected to fund company operations through CRPS-RISE Phase 3 topline results and planned NDA submission, with cash runway into 1H 2029 WALTHAM, Mass. and SAN DIEGO, Calif. – August 21, 2026 – Werewolf Therapeutics, Inc. (Nasdaq: HOWL) and Ambros Therapeutics, Inc., today announced that they entered into a definitive merger agreement to combine the companies in an all-stock transaction. The combined company will focus on advancing Ambros Therapeutics’ neridronate development program in Complex Regional Pain Syndrome Type 1