On August 24, 2026 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXL) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, reported that Bria-MEL+, its personalized whole cell melanoma immunotherapy vaccine candidate, has achieved a key genetic engineering milestone, advancing the program toward clinical development.

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Bria-MEL+ is a cell-based therapeutic cancer vaccine designed to harness a patient’s own immune system to combat melanoma. The program is personalized yet ‘off-the-shelf ’: a simple patient saliva test will determine which of the several premanufactured treatment cell lines will be selected for personalized treatment, avoiding the need to manufacture a unique product for each individual patient.

"Bria-MEL+ is designed to combine the advantages of personalized immunotherapy with the accessibility of an off-the-shelf vaccine," said William V. Williams, MD, President and Chief Executive Officer of BriaCell. "By eliminating individualized manufacturing, we believe this approach has the potential to broaden access, shorten treatment timelines, and reduce treatment costs while preserving patient-specific matching."

"Building on the encouraging efficacy and tolerability results from BriaCell’s metastatic breast cancer immunotherapy program, we continue to expand our pipeline with additional personalized, cell-based immunotherapy vaccine candidates, including Bria-MEL+ for melanoma," stated Miguel A. Lopez-Lago, PhD, BriaCell’s Chief Scientific Officer.

About Bria-MEL+

Bria-MEL+ is a personalized, off-the-shelf, genetically modified whole-cell cancer vaccine designed to activate multiple components of the immune system, including innate and adaptive immune responses, to target and destroy melanoma cells. The program is derived from BriaCell’s Bria-OTS+ (off-the-shelf) cellular immunotherapy platform and is being developed using premanufactured cell lines selected through patient HLA matching.

BriaCell’s Bria-MEL+ expands the Company’s personalized immunotherapy platform which is led by Bria-IMT, currently in a pivotal Phase 3 trial for metastatic breast cancer. BriaCell is also advancing Bria-OTS in breast cancer, in which the first patient dosed experienced sustained complete resolution of a lung metastasis, and Bria-PROS+ in prostate cancer which has recently received FDA clearance to initiate clinical evaluation. The Bria-MEL+, Bria-PROS+ and Bria-OTS programs are based on matching patient HLA type with the corresponding immunotherapy cell line.

Earlier In 2026, BriaCell reported preclinical data from the Bria-OTS+ platform at the AACR (Free AACR Whitepaper) Annual Meeting, Bria-OTS+ demonstrated activation of both adaptive and innate immunity, including naïve/resting T cells, dendritic cells, and natural killer (NK) cells, inducing immune memory and eliciting "serial killer" activity against cancer cells. BriaCell believes this multipronged immune activation supports the potential of the Bria-OTS+ platform to generate anti-tumor immune responses and informs the development of Bria-MEL+ for melanoma.

BriaCell has commenced development activities to support production of Bria-MEL+ for potential clinical use. Bria-MEL+ recently passed a key milestone in the genetic engineering process, streamlining the path to the clinic.

Melanoma Facts

The American Cancer Society estimates that approximately 112,000 new cases of melanomas will be diagnosed in the United States in 2026, including about 65,400 in men and 46,600 in women. Based on 2021–2023 Surveillance, Epidemiology, and End Results (SEER) data, approximately 2.2% of men and women will be diagnosed with skin melanoma during their lifetime.

Despite major advances in treatment, melanoma remains a significant unmet medical need. Approximately 8510 people are expected to die from melanoma in the United States in 2026, including about 5500 men and 3010 women. Melanoma accounts for only about 1% of skin cancers but causes a large majority of skin cancer deaths.

(Press release, BriaCell Therapeutics, AUG 24, 2026, View Source [SID1234670290])

On August 23, 2026 Anbogen Therapeutics Inc. (TPEx: 7784) ("Anbogen" or the "Company"), a clinical-stage precision oncology company, reported that it has entered into a Collaborative Research Agreement (CRA) with the Laboratory of Veterinary Surgery, Graduate School of Agricultural and Life Sciences, The University of Tokyo, to evaluate ABT-301 (Imofinostat), the Company’s selective Class I histone deacetylase inhibitor (HDACi), across multiple solid tumor types (including osteosarcoma, melanoma, soft tissue sarcoma, bladder cancers and other refractory solid tumors) using established veterinary oncology models.

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The collaboration will be led by Lecturer Daiki Kato, Professor Takayuki Nakagawa, and Professor Manabu Mochizuki, Director of the Affiliated Veterinary Medical Center, The University of Tokyo. The research team brings extensive expertise in translational oncology, cancer immunotherapy, and genomic medicine in companion animals, and operates one of Asia’s most comprehensive comparative oncology platforms.

Accelerating Human Clinical Development Through Comparative Oncology

The primary strategic objective of this collaboration is to generate the scientific evidence required to support the expansion of ABT-301’s human clinical indications and to optimize the compound’s combination strategies ahead of future clinical trials. Naturally occurring cancers in dogs are widely recognized as clinically and molecularly analogous to their human counterparts. Among these, canine osteosarcoma represents one of the most extensively studied comparative oncology models due to its remarkable biological and clinical similarities to human osteosarcoma. Insights generated from this naturally occurring disease provide a unique opportunity to evaluate therapeutic strategies at disease stages that are often difficult to study in early human clinical development, making canine data directly informative for human clinical trial design, patient selection strategies, and regulatory submissions. Using The University of Tokyo’s proprietary preclinical models, the collaboration will evaluate ABT-301 as a monotherapy and in combination with other agents, with comprehensive mechanistic analyses to elucidate its mechanism of action and identify the molecular backgrounds most predictive of response. Findings will directly inform indication selection and combination regimen design for future human trials.

Dr. John Hsu, Chairman and CEO of Anbogen Therapeutics, said: "Comparative oncology is far more than animal research. It is a powerful platform for generating cross-species translational evidence that can bridge preclinical findings and human clinical development. Through this collaboration, we aim to evaluate ABT-301 in models that more closely reflect real-world disease biology, generating scientifically robust translational data to support future indication expansion and clinical development decisions. This strategic partnership will enable us to systematically assess ABT-301 across a broad range of difficult-to-treat solid tumors and extend its clinical potential beyond our current colorectal cancer program. The resulting evidence will be critical for designing and supporting the expansion of our ongoing human clinical development into new indications."

ABT-301 is currently being evaluated in a Phase I/II clinical trial in combination with anti-PD-1 and anti-VEGF in patients with pMMR/non-MSI-High metastatic colorectal cancer. As an isoform-selective Class I HDACi, ABT-301 is designed to modulate the tumor immune microenvironment and sensitize tumors to immune checkpoint inhibition where lies the potential applicability across immunologically cold solid tumors. Importantly, independent Phase III clinical studies evaluating other HDAC inhibitors in combination with immune checkpoint inhibitors have demonstrated significant synergistic efficacy in advanced cancers, including a marked improvement in progression-free survival (PFS). These external clinical findings provide strong proof-of-concept for the HDAC inhibitor–immune checkpoint inhibitor combination strategy and further support the clinical development of ABT-301 across multiple cancer indications.

Dr. Daiki Kato, The University of Tokyo, said: "Naturally occurring cancers in dogs and cats develop spontaneously under environmental and lifestyle conditions shared with humans and evolve through immune editing to acquire complex tumor immune microenvironments. These unique characteristics enable naturally occurring canine and feline cancer models to faithfully recapitulate key biological, immunological, and clinical features that are difficult to reproduce in conventional preclinical models. We believe this collaborative research will generate robust translational evidence to support the clinical development of ABT-301. Our research team is fully committed to maximizing the scientific impact of this collaboration and to providing the scientific evidence needed to support indication expansion and future clinical development of ABT-301."

About ABT-301 (Imofinostat)

ABT-301 is an orally available, selective Class I HDAC inhibitor designed to reverse immune evasion in solid tumors by enhancing antigen presentation and promoting anti-tumor immune activity. ABT-301 is currently being evaluated in a Phase I/II clinical trial in combination with anti-PD-1 and anti-VEGF therapy for the treatment of metastatic colorectal cancer. The Company believes that ABT-301’s mechanism of action has broad applicability across multiple immunotherapy-resistant solid tumor types.

(Press release, Anbogen Therapeutics, AUG 23, 2026, View Source [SID1234670286])

On August 23, 2026 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biotech company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for autoimmune diseases, solid tumors and hematological malignancies, reported an overview of its interim results for the period ended June 30, 2026, which were announced on August 21, 2026, together with recent business highlights and strategic progress.

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Dr. Jay Mei, Antengene’s Founder, Chairman, and CEO, said, "In H1 2026, Antengene achieved its first‑ever profitability, with total revenue of RMB 513 million, representing a year‑on‑year increase of 864.5%, and profit for the period of RMB 216 million. This is an important validation of our strategy to create value through internal innovation and global partnerships. The successful execution of our partnering strategy is translating the strength of our pipeline into meaningful financial returns. Most notably, our global exclusive license agreement with UCB for ATG‑201 (CD19 x CD3 T‑cell engager [TCE]) generated a USD 60 million upfront payment. We also entered into an exclusive license agreement with K2 Therapeutics, established by MPM BioImpact, for ATG‑106 (first‑in‑class CDH6 x CD3 TCE), under which the aggregate upfront and near‑term consideration amounts to approximately USD 20 million. Together with potential milestone payments and tiered royalties from these partnerships, as well as commercial revenue from XPOVIO, these revenue streams further strengthen our financial position and expand our capacity to invest in innovation.

Our late-stage clinical program ATG‑022 (CLDN18.2 antibody‑drug conjugate [ADC]) has received CDE Breakthrough Therapy Designation, demonstrating strong efficacy and best-in-class safety in gastric cancer across all levels of CLDN18.2 expression, as well as in other CLDN18.2+ solid tumors. We are advancing two key clinical studies in gastric cancer: the CLINCH‑2 study, evaluating ATG‑022 in combination with chemotherapy and an anti‑PD‑1 antibody in the 1L treatment of patients with gastric or gastroesophageal junction adenocarcinoma (GC/GEJC) with CLDN18.2 IHC 1+ ≥ 1%; and the pivotal Phase III CLINCH‑3 study evaluating ATG-022 monotherapy for GC/GEJC patients with CLDN18.2 IHC 2+ ≥ 20%. We are confident in the potential of ATG-022 to benefit a broad population of patients with CLDN18.2-expressing tumors and believe it is well positioned to become a cornerstone of our pipeline and one of our most important future value drivers.

In TCE innovation, we continue to expand our capabilities beyond our established AnTenGager TCE platform. We have successfully developed and newly launched TriGager, our next generation logic-gated tri-specific TCE platform, together with new TCE formats incorporating costimulatory moieties, further broadening our comprehensive TCE engineering toolbox. We are also deepening the integration of AI across our R&D engine. By linking multi-omics analysis with internally generated protein datasets, our AI platform identifies novel targets and target combinations, informs molecular design, and optimizes antibody developability. The platform has already contributed to the nomination of ATG-115, a T-cell engager (TCE) for hepatocellular carcinoma (HCC) directed at a novel, AI-identified tumor-associated antigen. AI-enabled combinatorial screening has also surfaced multiple novel target pairs now advancing toward future TriGager programs. Combined with the differentiated engineering of our AnTenGager and TriGager platforms, AI expands the range of molecules we can design for diseases of high unmet medical need.

Beyond these programs, we are advancing the next wave of internally generated innovation. ATG-125, our B7-H3 x PD-L1 bispecific ADC, has demonstrated encouraging preclinical efficacy, with an IND submission planned for Q1 2027. ATG-207, our first-in-class αCD3-TGF-β bifunctional fusion protein, represents a differentiated approach to restoring immune tolerance in T cell-mediated autoimmune disease. ATG‑112, our first‑in‑class ALPPL2 × CD3 TCE, targets gynecological tumors, digestive system malignancies, bladder cancer and NSCLC. ATG‑110, our LY6G6D × CD3 TCE, targets IO‑resistant microsatellite‑stable colorectal cancer. Together, these programs highlight the breadth of our innovation and represent potential future value drivers across oncology and autoimmune diseases.

As Antengene enters its next stage of development, we will continue to strengthen our R&D capabilities, advance our clinical pipeline and deepen global partnerships. With sustained innovation and a stronger financial position, we are well positioned to execute our strategy and create long‑term value."

1.ATG-022（CLDN18.2 ADC）

Latest data from the Phase II CLINCH study: As of June 26, 2026, among patients with moderate to high CLDN18.2 expression (IHC 2+ ≥ 20%), the 2.4 mg/kg dose cohort achieved an objective response rate (ORR) of 42.4% (14/33) and a disease control rate (DCR) of 90.9% (30/33), with a median overall survival (mOS) of 12.85 months. In the 1.8 mg/kg dose cohort, the ORR was 46.7% (14/30), the DCR was 86.7% (26/30), and the mOS had not yet been reached after a median follow‑up of 14.03 months. Among patients with low/ultra-low CLDN18.2 expression treated at the efficacious dose range of 1.8-2.4 mg/kg, the ORR was 28.6% (6/21) and the DCR was 52.4% (11/21). In addition, one patient in each of the three cohorts achieved a complete response (CR). These results demonstrated the robust anti-tumor activity of ATG-022 across all levels of CLDN18.2 expression.
Favorable safety profile: Compared with the data cutoff of December 25, 2025, the incidence of Grade ≥3 treatment‑related adverse events (TRAEs) in the 1.8 mg/kg dose cohort increased slightly from 19.4% to 21.0%, with only 9.7% of patients experiencing dose reduction due to TRAEs. Despite more than six additional months of treatment exposure and follow‑up, the incidence of Grade ≥3 TRAEs remained broadly stable in the 1.8 mg/kg dose cohort. This favorable safety profile supports the continued development of ATG‑022 in combination with chemotherapy and an anti-PD-1 antibody in the 1L setting, further expanding its therapeutic potential.
mOS not yet reached in the 1.8 mg/kg dose cohort: After a median follow‑up of 14.03 months, mOS had not yet been reached in the 1.8 mg/kg dose cohort, further supporting the potential for durable clinical benefit with ATG-022.
Three Complementary Development Paths Position ATG-022 for Near-Term Registration, 1L Leadership, and Broader Patient Reach: CLINCH-3 provides a near-term registration pathway for ATG-022 monotherapy at the optimized 1.8 mg/kg dose in 3L+ gastric/GEJ cancer with CLDN18.2 IHC 2+ ≥ 20%, establishing ATG-022 in gastric cancer. CLINCH-2 is evaluating ATG-022 in 1L in combination with standard-of-care chemotherapy and anti-PD-1 therapy, targeting the broadest CLDN18.2-positive population starting from IHC 1+ ≥ 1%, with the goal of supporting 1L registration and unlocking the full potential of ATG-022 in gastric cancer. Meanwhile, the CLINCH basket trial is expanding ATG-022 beyond gastric cancer, with encouraging efficacy already observed in a gynecological tumor subtype and other CLDN18.2-positive solid tumors.
2. AnTenGager & TriGager TCE Platforms

There is no one-size-fits-all approach to designing TCE molecules across different targets and indications. Achieving optimal balance between efficacy and safety requires tailoring each molecule to the underlying target biology. To this end, Antengene has built a comprehensive TCE engineering toolbox comprising its proprietary AnTenGager and TriGager platforms, together with multiple functional modules. This modular system enables Antengene’s R&D team to customize molecular formats and designs for different targets, improving development efficiency while supporting differentiated clinical strategies.

AnTenGager TCE platform: AnTenGager is Antengene’s proprietary, second-generation TCE platform featuring "2+1" bivalent binding format for low-expressing targets, steric hindrance masking, and proprietary CD3 sequences with fast on/off kinetics to minimize cytokine release syndrome (CRS) and enhance efficacy. These differentiated features support the platform’s broad applicability across autoimmune diseases, solid tumors and hematological malignancies indications. Leveraging this platform, Antengene has built a pipeline of multiple drug candidates, two of which have entered into exclusive out-licensing agreements:
ATG-201 (CD19 x CD3 TCE): Antengene entered into a global exclusive license agreement with UCB. The Company has received USD 60 million upfront payment from UCB to date and is eligible to receive an additional USD 20 million near‑term milestone payment, up to approximately USD 1.1 billion in additional milestone payments, as well as tiered royalties on future net sales. ATG‑201 has obtained approvals from China’s National Medical Products Administration (NMPA) to initiate the Phase I ATTRACT study for the treatment of B cell related autoimmune diseases.
ATG-106 (first-in-class CDH6 x CD3 TCE): Antengene entered into an exclusive license agreement with K2 Therapeutics, a company established by MPM BioImpact. The aggregate upfront and near‑term considerations amounts to approximately USD 20 million. We are also eligible to receive up to USD 960.5 million in additional milestone payments, as well as tiered royalties on future net sales. The Company plans to submit an IND application for ATG-106 in H1 2027.
TriGager TCE platform: TriGager is Antengene’s proprietary tri‑specific TCE platform incorporating steric hindrance masking technology and supporting multiple logic-gated formats, including AND‑Gate, True AND‑Gate and OR‑Gate. AND‑Gate and True AND‑Gate molecules require target cells to co‑express two disease‑associated antigens before T‑cell‑mediated cytotoxicity can be triggered. This mechanism improves target specificity, reduces on-target-off-tumor toxicity, and expands the pool of druggable targets for TCE modalities. In contrast, OR‑Gate molecules trigger T‑cell‑mediated killing upon recognition of either one of the disease‑associated antigens, helping address heterogeneity in target expression. The platform also supports the incorporation of an engineered CD2 co‑stimulatory moiety, which optimizes molecular developability, enhances TCE potency, and mitigates the risk of CRS, further optimizing the balance between efficacy and safety.
3. Next Generation ADCs and Other Novel Programs

ATG-125 (B7-H3 x PD-L1 bispecific ADC): ATG-125 is an "IO + ADC" dual-function molecule targeting B7-H3 and PD-L1, integrating the direct cytotoxic activity of an ADC with the durable immune activation of IO therapies. By simultaneously blocking B7-H3- and PD-L1-mediated immunosuppressive signaling, ATG-125 effectively activates T cells and induces immunological memory. Preclinical studies demonstrate that the bispecific ADC delivers superior in vivo efficacy compared with single-target ADC approaches. The Company plans to submit an IND application for ATG-125 in Q1 2027.
ATG-207 (αCD3-TGF-β Bifunctional Fusion Protein): ATG-207 is a globally first-in-class αCD3-TGF-β bifunctional fusion protein being developed for the treatment of T cell–mediated autoimmune diseases. The Company first disclosed its preclinical data at the 2026 European Congress of Rheumatology (EULAR 2026).
【Highlights of Financial Results】

As of the end of the reporting period, the Company recorded total revenue of RMB 513 million for H1 2026, representing a year‑on‑year increase of 864.5%. Profit for the period stood at RMB 216 million, marking the Company’s first profitable period.
As of June 30, 2026, the Company held cash and bank balances of RMB 765 million. In addition, under the license agreement with UCB, the Company received license revenue of approximately RMB 195 million from UCB in July 2026. The Company is also eligible to receive a near‑term milestone payment of approximately RMB 136 million.
To learn more about the 2026 interim results, please see the full announcement in the "Investor Relations" section on the company’s website.

(Press release, Antengene, AUG 23, 2026, View Source [SID1234670285])

On August 23, 2026 Orum Therapeutics ("Orum" or the "Company") (KRX: 475830), a biotechnology company pioneering the field of degrader-antibody conjugates (DACs), reported that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for ORM-1153, a CD123-GSPT1 DAC. Orum plans to initiate a first-in-human Phase 1 study of ORM-1153 in patients with relapsed or refractory acute myeloid leukemia (AML) and other hematologic malignancies by the end of 2026.

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"FDA clearance of the IND for ORM-1153 is an important milestone for Orum, bringing another first-in-class DAC into the clinic and extending our approach into CD123-expressing hematologic malignancies," said Olaf Christensen, M.D., Chief Medical Officer of Orum Therapeutics. "By combining cell-selective delivery with targeted protein degradation in a single molecule, we believe ORM-1153 has the potential to improve treatment efficacy and tolerability for patients with severe hematologic malignancies."

ORM-1153 uses Orum’s TPD² approach to deliver a GSPT1 degrader payload to CD123-expressing cells, enabling targeted degradation of GSPT1. In preclinical studies presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, ORM-1153 demonstrated broad activity across AML models, including activity in primary AML patient samples and TP53-relevant models, as well as low-dose in vivo activity and favorable repeat-dose tolerability.

The first-in-human Phase 1 study will assess the safety and tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of ORM-1153 in patients with relapsed or refractory AML and other hematologic malignancies. The multicenter study is expected to enroll approximately 42 patients initially at U.S. clinical sites, with potential expansion to other regions.

Orum will host a conference call on Monday, August 24, at 7:00 a.m. KST (Sunday, August 23, at 6:00 p.m. EDT) to discuss the ORM-1153 IND clearance and provide a high-level overview of the Phase 1 clinical study. Conference call details are available at View Source

About Orum’s TPD² Approach

Orum’s unique Dual-Precision Targeted Protein Degradation (TPD²) approach builds novel targeted protein degraders combined with the precise cell delivery mechanisms of antibodies to generate innovative, first-in-class, cell-selective TPDs for the treatment of cancer and other serious diseases. Orum has developed new targeted protein degrader payloads to specifically degrade an intracellular target protein within cancer cells via the E3 ubiquitin ligase pathway. Conjugated to antibodies, the payloads are designed to be delivered specifically to target cells and precisely degrade the intracellular target protein of interest.

(Press release, Orum Therapeutics, AUG 23, 2026, View Source [SID1234670284])

On August 21, 2026 Werewolf Therapeutics, Inc. (Nasdaq: HOWL) and Ambros Therapeutics, Inc., reported 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 ("CRPS-1", formerly known as Reflex Sympathetic Dystrophy). Upon completion of the merger, the combined company will operate as Ambros Therapeutics, headquartered in San Diego, California, and is expected to trade under the Nasdaq ticker symbol "AMBX".

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In connection with the proposed merger, the companies secured commitments for an oversubscribed concurrent private placement of $150 million from a syndicate of leading healthcare-dedicated investors co-led by RA Capital Management and Janus Henderson Investors. The private placement includes participation from Aberdeen Investments, Adage Capital Partners, L.P., ADAR1 Capital Management, Affinity Asset Advisors, LLC, Arkin Bio Capital, Balyasny Asset Management, Patient Square Capital’s platform Enavate Sciences, SilverArc Capital, Sphera Healthcare, and Woodline Partners LP as well as other new and existing investors. The private placement is expected to close concurrently with the proposed merger, at which time Werewolf Therapeutics will issue common stock and pre-funded warrants for aggregate gross proceeds of $150 million. Ambros Therapeutics expects the combined company to be fully funded through topline results from the pivotal CRPS-RISE Phase 3 clinical trial expected in 2028 and a planned New Drug Application ("NDA") submission to the U.S. Food and Drug Administration ("FDA") for potential approval of neridronate in patients with CRPS-1, with cash runway into the first half of 2029.

"We are uniquely positioned to be advancing neridronate, a differentiated bisphosphonate with extensive prior clinical experience, in an FDA-aligned single Phase 3 trial supporting potential regulatory approval in patients with CRPS-1, a debilitating orphan disease with no currently FDA-approved therapy," said Jay Hagan, Chief Executive Officer of Ambros Therapeutics. "With the capital raised through this financing from a leading investor syndicate, we expect to be fully funded through potentially value-generating topline results of our pivotal CRPS-RISE Phase 3 trial and have the resources to advance a potential NDA submission and commercial preparations. Our strengthened foundation resulting from today’s transformative announcement positions us to deliver value on behalf of patients, investors and all other stakeholders."

"Following a comprehensive review of strategic options, management and the board of directors believe a merger with Ambros Therapeutics is in the best interest of Werewolf Therapeutics’ stockholders. The Ambros management team’s extensive track record, drug development expertise and the potential of neridronate to deliver a meaningful treatment to patients with CRPS-1 is very compelling," said Daniel J. Hicklin, Ph.D., President and Chief Executive Officer of Werewolf Therapeutics. "Neridronate, which has received the FDA’s Breakthrough Therapy, Fast Track, and Orphan Drug designations, is a differentiated bisphosphonate with the potential to redefine the standard of care for patients with CRPS-1."

Proceeds from the proposed transaction will be used to advance the clinical development of neridronate, a differentiated bisphosphonate that has demonstrated lasting pain reduction along with improvement in other CRPS-related symptoms.

Neridronate is advancing in the pivotal CRPS-RISE Phase 3 clinical trial ("CRPS-RISE"), a multicenter, randomized, triple-blind, placebo-controlled clinical trial designed to assess the efficacy, safety and tolerability of neridronate in patients with warm CRPS-1. CRPS-RISE leverages a precision medicine approach focused on diagnosed CRPS-1 patients in the warm-phase of the disease with positive triple-phase bone scans ("TPBS"), whose disease biology most closely aligns with neridronate’s proposed mechanism and where prior clinical evidence suggests the treatment effect may be greatest. The primary efficacy endpoint is change in pain intensity from baseline to week 12 as measured on an 11-point Numerical Rating Scale. Key secondary endpoints include other measures of pain reduction and patient reported outcomes. The program includes a registry for long-term outcomes and an opportunity for CRPS-RISE participants with active disease who completed the study to receive neridronate. Based on interactions with the FDA, Ambros Therapeutics believes that positive results from a single pivotal trial such as CRPS-RISE could support potential U.S. approval. Ambros Therapeutics anticipates reporting topline data from CRPS-RISE in 2028. Along with Orphan Designation, Ambros Therapeutics’ intellectual property portfolio supports the potential for neridronate’s U.S. market exclusivity through 2045.

About the Proposed Merger

Under the terms of the merger agreement, Werewolf Therapeutics will issue to pre-merger Ambros Therapeutics stockholders shares of Werewolf Therapeutics common stock (or pre-funded warrants in lieu thereof) as merger consideration in exchange for the cancellation of shares of capital stock of Ambros Therapeutics, and Ambros Therapeutics will become a wholly owned subsidiary of Werewolf Therapeutics. Stockholders of Ambros Therapeutics will receive newly issued shares of Werewolf Therapeutics common stock (or pre-funded warrants in lieu thereof) pursuant to a formula set forth in the merger agreement. The exchange ratio is based on an implied value of Ambros Therapeutics of $500 million (before giving effect to the concurrent private placement) and an implied value of Werewolf Therapeutics of $47.5 million. Pre-merger Werewolf Therapeutics stockholders (other than those investors participating in the private placement) are expected to own approximately 6.8% of the combined company, pre-merger Ambros Therapeutics stockholders are expected to own approximately 71.7% of the combined company and investors participating in the private placement are expected to own approximately 21.5% of the combined company. The percentage of the combined company that pre-merger Ambros Therapeutics stockholders and pre-merger Werewolf Therapeutics stockholders will own upon the closing of the merger is further subject to adjustment based on the amount of Werewolf Therapeutics’ net cash at the time of closing. In connection with the closing of the proposed transactions, Werewolf Therapeutics stockholders (other than those investors participating in the private placement) will also be issued a contingent value right representing the right to receive certain payments from net proceeds received by the combined company, if any, related to dispositions of Werewolf Therapeutics’ pre-transaction legacy assets.

The merger agreement has been approved by the boards of directors of both companies. The transaction is expected to close by the first quarter of 2027, subject to certain closing conditions, including the approval by the stockholders of each company, the shares of Werewolf Therapeutics common stock issuable in the transaction having been approved for listing on Nasdaq, effectiveness of the registration statement on Form S-4 (the "Form S-4") and the satisfaction of other customary closing conditions.

Additional information about the transaction will be provided in a Current Report on Form 8-K that will be filed by Werewolf Therapeutics with the Securities and Exchange Commission (the "SEC") and will be available at www.sec.gov.

Leerink Partners, Piper Sandler, Cantor and Wells Fargo Securities are serving as placement agents for the concurrent private placement. LifeSci Capital is also serving as a placement agent. Cooley LLP is serving as legal counsel to Ambros Therapeutics. Piper Sandler is serving as the exclusive financial advisor, and Sidley Austin LLP is serving as legal counsel, to Werewolf Therapeutics. Latham & Watkins LLP is serving as legal counsel to the placement agents.

Management and Organization

Upon closing of the proposed transaction, the combined company will be led by current members of the Ambros Therapeutics leadership team including:

Joseph (Jay) Hagan, Chief Executive Officer
Cris Calsada, Chief Financial Officer
Gail Cawkwell, M.D., Ph.D., Chief Medical Officer
Christopher Aker, General Counsel
Kunal Kishnani, SVP of Corporate Development
Members of Ambros Therapeutics’ existing board of directors will become directors of the combined company.

About Neridronate

Neridronate is a differentiated bisphosphonate that was developed by Abiogen Pharma S.p.A. Neridronate is approved and marketed in Italy for the treatment of Complex Regional Pain Syndrome ("CRPS"); clinical studies have demonstrated lasting pain reduction along with improvements in other CRPS related symptoms. Beyond CRPS, neridronate is also approved in Italy for osteogenesis imperfecta and Paget’s disease and has been administered to approximately 600,000 patients across approved indications. Its well-established safety and tolerability profile and therapeutic benefits make it a potential promising treatment for patients with CRPS-1 worldwide. Recognizing its potential, the FDA has granted neridronate Breakthrough Therapy, Fast Track, and Orphan Drug designations for the treatment of CRPS.

About CRPS-1

CRPS-1 is a severely painful, debilitating orphan disease typically following a limb injury affecting an estimated 65,000 newly diagnosed people in the United States each year. There are currently no FDA-approved medicines available to treat this high unmet need patient population. The condition is characterized by intense pain that can be continuous in the affected limb such as the arm, leg, hand or foot. Patients with CRPS-1 often experience an evolving condition commencing with a "warm" phase that typically predominates in the first year after onset where inflammation and other mechanisms cause the affected limb to become red, swollen, warm, and hypersensitive to pain. In many patients, the disease progresses to a chronic "cold" phase, where the affected limb changes its presentation and patients face ongoing, debilitating pain.

About CRPS-RISE

CRPS-RISE is a Phase 3, multicenter, randomized, triple-blind, placebo-controlled clinical trial designed to assess the efficacy, safety and tolerability of neridronate in patients with warm CRPS-1. The trial will evaluate approximately 270 participants randomized 1:1 to receive either intravenous ("IV") neridronate or placebo. To be eligible for the trial, participants must have a confirmed CRPS-1 diagnosis per the Budapest Clinical Criteria, a known precipitating event (e.g. fracture, sprain, contusion), CRPS-1 duration of 6 months or less and moderate to severe pain. Additionally, participants must have characteristics that Ambros Therapeutics believes make them more likely responders to neridronate treatment: a positive triple phase bone scan and specific attributes of the warm CRPS-1 subtype. Following an initial screening period of two to six weeks, participants will receive four IV infusions over 10 days of either 100 mg neridronate (400 mg total dose) or placebo followed by a post-treatment period through week 12. The primary efficacy endpoint is change in pain intensity from baseline to week 12 as measured on an 11-point Numerical Rating Scale. Key secondary endpoints include other measures of pain reduction and patient reported outcomes. The program includes a registry for long-term outcomes and an opportunity for CRPS-RISE participants with active disease who completed the study to receive neridronate.

(Press release, Werewolf Therapeutics, AUG 21, 2026, View Source [SID1234670281])