Werewolf Therapeutics, Inc. · NASDAQ:HOWL
Werewolf Therapeutics — Merger or Acquisition (November 2026)
36 slides from Werewolf Therapeutics's merger presentation, Nov 10, 2026
Slide 1: Ambros Analyst Day November 2026
AMBROS” Seeking a potential breakthrough therapy for patients with Complex Regional Pain Syndrome Type 1 (CRPS-1) a Analyst Day November 2026
Slide 2: Disclaimer
2 Disclaimer This presentation and the accompanying slides and oral commentary (this “Presentation”) have been prepared by Ambros Therapeutics, Inc. (“Ambros,” “we,” “us” or the “Company”) for informational purposes only. This Presentation has been prepared based on information the Company considers
Slide 3: Ambros Analyst Day Agenda
3 Ambros Analyst Day Agenda Introduction and Corporate Overview Jay Hagan Werewolf Transaction and Concurrent Financing Cris Calsada Complex Regional Pain Syndrome Overview Gail Cawkwell, MD, PhD Neridronate: Mechanism, Clinical Evidence to Date, and Ongoing Trial Gail Cawkwell, MD, PhD Market Oppor
Slide 4: Experienced Leadership Team and Board of Directors
Christopher Aker General Counsel General Counsel at Regulus Therapeutics Corporate Counsel & Senior Director of Administration at Phenomix Corp Corporate Counsel at Cureline Jennifer Lam SVP Finance and Administration SVP Finance and Administration at Reneo Pharmaceuticals VP of Finance at Amplyx Ph
Slide 5: History of Strong and Rapid Execution Since Founding
5 History of Strong and Rapid Execution Since Founding September 2024 Ambros’ Inception December 2024 Signed the License for Neridronate with Abiogen Late 2024/Early 2025 $12.5 million Seed Financing April 2025 Aligned with the FDA on One Phase 3 Trial of Neridronate for Potential Approval December
Slide 6: Neridronate potential first FDA-approved medicine for CRPS-1
Neridronate has the potential to become the first and only FDA-approved medicine for Complex Regional Pain Syndrome Type 1 (CRPS-1) CRPS-1 Rare Disease Burden ~65,000 newly diagnosed individuals each year in the U.S.1 Severely painful and debilitating condition following injury Long-lasting disabili
Slide 7: Pending Transaction with Werewolf Therapeutics and Concurrent Financing
7 Pending Transaction with Werewolf Therapeutics and Concurrent Financing
Slide 8: Transaction Highlights
Transaction Highlights 8 Transaction Structure Reverse triangular merger of a wholly owned subsidiary of Werewolf Therapeutics (public company) with and into Ambros Therapeutics (private company) Ambros survives as a wholly owned subsidiary of Werewolf Post-closing, the combined company will be rena
Slide 9: CRPS-1: a debilitating disease with no approved US therapy
9 Complex Regional Pain Syndrome Type 1 (CRPS-1): a debilitating disease with no approved US therapy
Slide 10: CRPS-1 is an orphan disease with ~65,000 newly diagnosed each year
CRPS-1 is an orphan disease with ~65,000 newly diagnosed individuals each year in the U.S.2 CRPS-1 is a progressive, debilitating orphan disease typically triggered by injury or trauma, such as bone fractures or limb surgeries Considered among the most painful of all known diseases with high unmet n
Slide 11: CRPS-1 progresses through stages of increasing severity post-injury
CRPS-1 progresses through stages of increasing severity post-injury~50% of patients in the U.S. are currently diagnosed within first 6 months of symptom onset1 Stage 1: “Warm” Phase (typically 0-12 months post-injury)2 Burning pain, allodynia, hyperalgesia Increased warmth and redness in the affecte
Slide 12: CRPS treatment in the US largely focuses on pain management
12 CRPS treatment in the US largely focuses on pain management, but most treatments have little efficacy Srinivasa N Raja, Asokumar Buvanendran & Lizandra Marcondes (2021) Complex Regional Pain Syndrome: A Comprehensive Qualitative Research Study on Unmet Needs in the “Patient Journey”, Journal of P
Slide 13: Neridronate: mechanism and clinical evidence to date
13 Neridronate: mechanism and clinical evidence to date
Slide 14: Neridronate is a differentiated bisphosphonate approved in Italy
Neridronate is a differentiated bisphosphonate approved in Italy for the treatment of several bone disorders including CRPS1 Originally developed by Abiogen Pharma S.p.A. under the trade name NERIXIA® Approved in Italy for the treatment of Osteogenesis Imperfecta, Paget’s Disease, and CRPS1 We have
Slide 15: Proposed disease processes and mechanism of neridronate
Derived from: Varenna M. Bisphosphonates beyond their anti-osteoclastic properties The lesson of complex regional pain syndrome. Rheumatology 2014;53:965-7, Tzschentke TM. Pharmacology of bisphosphonates in pain. Br J Pharmacol. 2021; 178: 1973–1994. https://doi.org/10.1111/bph.14799, Maksymowych WP
Slide 16: Abiogen NERIAS Phase 3 study with IV neridronate
100 mg neridronate or placebo administered intravenously (IV) on days 1, 4, 7, and 10* Primary endpoint of pain intensity assessed by visual analog scale (VAS, range 0-100 mm) at day 40 Open-label placebo cross-over phase after 10-day washout Key inclusion criteria: Confirmed diagnosis of CRPS-1 No
Slide 17: NAIMES achieved primary endpoint at Day 30
NAIMES achieved primary endpoint measured at Day 30: 65.9% of neridronate-treated versus 29.7% on placebo achieved at least a 50% improvement in pain (p=0.0017) Following completion of the double-blind portion of the Phase 3 IM study, placebo participants were treated with 400 mg IV neridronate (4 d
Slide 18: Grünenthal licensed neridronate and ran two global Phase 3 trials
In 2013, Grünenthal licensed rights to neridronate and ran two global Phase 3 clinical trials1 Positive Grünenthal study was driven by subset of participants with CRPS-1 and warm subtype findings at baseline 18 Ambros is building on the successful Abiogen studies in warm phase CRPS-1 Also conducted
Slide 19: Neridronate efficacy aligns with mechanism of action
19 Neridronate efficacy in CRPS aligns with mechanism of action:Better response in bone-focused type, with warm phase signs Participants with CRPS-1 improved by 1.6 points on a scale where a 1-pt improvement is relevant Those with CRPS-2 had ~ no response in this Grünenthal study (post hoc analysis)
Slide 20: Better responses with warm, inflammatory disease stage
20 Neridronate efficacy in CRPS aligns with mechanism of action:Better responses with warm, inflammatory disease stage Adami G, et al. (2025, Nov 13-15). A precision medicine approach to identifying patients with complex regional pain syndrome type 1 who may benefit from neridronate [Poster presenta
Slide 21: Ongoing pivotal Phase 3 study (CRPS-RISE)
Ongoing pivotal Phase 3 study (CRPS-RISE) builds on successful Abiogen program Key Eligibility CRPS-1 diagnosed per clinical Budapest criteria A known precipitating event (e.g., sprain, fracture, contusion) CRPS duration ≤6 months Moderate-severe pain >4 on 11-point NRS (average weekly) Precision me
Slide 22: Neridronate has been generally well-tolerated
Neridronate has been generally well-tolerated across all clinical trials and in post-marketing experience The tolerability profile of neridronate in CRPS is consistent with the tolerability profiles of other IV bisphosphonates given over a short term; however, no meaningful changes in renal functio
Slide 23: Neridronate is Differentiated from other Bisphosphonates
Neridronate is Differentiated from other BisphosphonatesIndividual bisphosphonates differ meaningfully in their pharmacological properties Oral bisphosphonates have single-digit bioavailability which is unlikely to be sufficient for CRPS where a short time to a high exposure is felt to be important.
Slide 24: Market Opportunity and Lifecycle
24 Market Opportunity and Lifecycle
Slide 25: Potentially first-in-class therapy with a large U.S. market opportunity
Neridronate is a potentially first-in-class therapy for CRPS-1 with a large U.S. market opportunity 25 1 Opportunity to establish standard of care No FDA-approved pharmacological therapies; current options limited, lack efficacy, costly, and complex Potentially disease-modifying mechanism Addresses
Slide 26: Initial addressable market considerations
Initial addressable market considerations ~65,000 newly diagnosed CRPS-1 patients annually in the U.S.1 Implied annual U.S. addressable population: 30,000+ patients Estimated % of patients with warm-phase CRPS-1 ~80% to 90%+ first 6 months from onset2 ~70 to 75% months 6 – 12 from onset2 × ~85% of t
Slide 27: Pain specialists are the primary prescribers
Pain specialists are the primary prescribers, supported by a referral network with hand and foot specialists 27 We plan to establish a targeted specialty sales force to reach the majority of U.S. CRPS-1 patients ~65% of CRPS-1 diagnoses come from four specialties1 Key prescribers concentrated in pai
Slide 28: IP, regulatory exclusivity, CMC readiness, and Abiogen license
28 IP, regulatory exclusivity, CMC readiness, and Abiogen license
Slide 29: Neridronate protected through IP and high barrier to entry
Neridronate protected through IP and high barrier to entry U.S. market exclusivity Methods for patient selection patent granted (exp. 2045) 7-year Orphan exclusivity; potential 6-month pediatric exclusivity Limitations of other bisphosphonates Differentiated from other branded/generic bisphosphonate
Slide 30: Abiogen License Agreement
30 Abiogen License Agreement Owns >5% of Ambros post merger closure Manages all manufacturing of commercial product Established manufacturing capabilities that support their owned products, and partnered products >1 million square foot manufacturing plant that meets the strict Good Manufacturing Pra
Slide 31: Pro forma financial position, cash runway, key milestones and newsflow
31 Pro forma financial position, cash runway, key milestones and expected newsflow
Slide 32: Strong Capital Position
Strong Capital Position ~$103.2M in cash, cash equivalents, and short-term investments as of 6/30/20261 FDA engagement on incorporating interim analysis in CRPS-RISE First Patient Enrolled in Pivotal CRPS-RISE Trial (June 2026) 2028 Pivotal CRPS-RISE Topline Data Readout Neridronate NDA Submission 1
Slide 33: Appendix
Appendix __ a
Slide 34: Abiogen NAIMES Phase 3 study with neridronate administered IM
Abiogen NAIMES Phase 3 study with neridronate administered IM D: IM study treatment dosed. IM: Intramuscular. Varenna M et al. Intramuscular neridronate for the treatment of complex regional pain syndrome type 1: a randomized, double-blind, placebo-controlled study. Ther Adv Musculoskelet Dis. 2021
Slide 35: Utility of triple-phase bone scan as a precision medicine tool
Utility of triple-phase bone scan (TPBS) as a “precision medicine” tool in CRPS-1 TPBS is an imaging procedure that uses a radiolabeled bisphosphonate (BP) and specialized camera to assess bone involvement BPs bind to hydroxyapatite, a calcium mineral exposed during the warm phase of CRPS-11 Qualita
Slide 36: Abiogen IV NERIAS Study cross-over responses
Abiogen IV NERIAS Study Demonstrated Responses Similar Whether Treated Initially or in the Cross-Over Phase, After Day 40 + Washout Period Draft - Confidentail - Preliminary for Discussion 36 Placebo in double-blind phase Neridronate in cross over phase following placebo in double-blind phase Neridr
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