Galera Therapeutics Announces Acquisition of Dismutase Mimetics Portfolio by Toronto-based Biossil for up to $105 Million
Galera Therapeutics (OTC: GRTX) entered an asset purchase agreement with Toronto-based Biossil for its dismutase mimetics portfolio, including avasopasem and rucosopasem.
Terms include an upfront $3.5 million payment and potential regulatory, commercial, and contingent payments totaling up to $105 million. Biossil will assume obligations under the 2018 Royalty Agreement, including a 4% royalty if either agent is commercialized. Galera will continue to advance its lead pan-NOS inhibitor (L-NMMA/tilarginine) in a multicenter Phase 2 trial for metaplastic breast cancer.
Notable data: a 407-patient Phase 3 of avasopasem showed a 16% relative reduction in severe oral mucositis (p=0.045) and a 56% reduction in SOM duration (p=0.002); FDA granted Fast Track and Breakthrough designations for avasopasem.
Galera Therapeutics (OTC: GRTX) ha stipulato un accordo di vendita di asset con Biossil, con sede a Toronto, per il suo portafoglio di mimetici della dismutasi, inclusi avasopasem e rucosopasem.
I termini prevedono un pagamento iniziale di 3,5 milioni di dollari e pagamenti regolatori, commerciali e contingenti fino a un massimo di 105 milioni di dollari. Biossil assumerà gli obblighi previsti dall'Accordo sulle royalties del 2018, inclusa una royalty del 4% se uno dei due agenti sarà commercializzato. Galera continuerà a avanzare il suo principale inibitore pan-NOS (L-NMMA/tilarginina) in uno studio multicentrico di fase 2 per il cancro mammario metaplastico.
Dat noti: in uno studio di fase 3 su 407 pazienti di avasopasem è stata osservata una riduzione relativa del 16% della mucosite orale grave (p=0,045) e una riduzione del 56% della durata della SOM (p=0,002); la FDA ha concesso designazioni Fast Track e Breakthrough per avasopasem.
Galera Therapeutics (OTC: GRTX) firmó un acuerdo de compra de activos con Biossil, con sede en Toronto, para su portafolio de miméticos de dismutasa, que incluye avasopasem y rucosopasem.
Los términos incluyen un pago inicial de 3,5 millones de dólares y pagos regulatorios, comerciales y contingentes por hasta 105 millones de dólares. Biossil asumirá las obligaciones bajo el Acuerdo de Regalías de 2018, incluida una regalía del 4% si cualquiera de los agentes se comercializa. Galera continuará avanzando su principal inhibidor pan-NOS (L-NMMA/tilarginina) en un ensayo multicéntrico de fase 2 para el cáncer de mama metaplástico.
Datos notables: un ensayo de fase 3 en 407 pacientes de avasopasem mostró una reducción relativa del 16% en la mucositis oral grave (p=0,045) y una reducción del 56% en la duración de la SOM (p=0,002); la FDA concedió designaciones de Fast Track y Breakthrough para avasopasem.
Galera Therapeutics (OTC: GRTX)가 토론토에 본사를 둔 Biossil과 자산 매매 계약을 체결했습니다. 이는 avasopasem와 rucosopasem을 포함한 디스뮤타제 모방 약물 포트폴리오에 대한 것입니다.
조건에는 선지급 350만 달러와 규제, 상업 및 조건부 지급이 총 1억 500만 달러까지 가능이 포함됩니다. Biossil은 2018년 로열티 계약의 의무를 인수하며, 4% 로열티가 부과될 수 있습니다. Galera는 다기관 2상 시험으로 metaplastic 유방암에 대한 선도적 pan-NOS 억제제(L-NMMA/tilarginine)의 개발을 계속합니다.
주목할 데이터: avasopasem의 407명 대상 3상에서 심한 구강 점막염의 상대적 감소 16%(p=0.045)와 SOM 지속 기간의 56% 감소(p=0.002)가 관찰되었고; FDA는 avasopasem에 대해 Fast Track 및 Breakthrough 지정을 부여했습니다.
Galera Therapeutics (OTC: GRTX) a conclu un accord d'achat d'actifs avec Biossil, basé à Toronto, pour son portefeuille de mimétiques de la dismutase, incluant avasopasem et rucosopasem.
Les conditions prévoient un paiement initial de 3,5 millions de dollars et des paiements réglementaires, commerciaux et éventuels totalisant jusqu'à 105 millions de dollars. Biossil assumera les obligations liées à l'Accord sur les redevances de 2018, y compris une redevance de 4% si l'un des agents est commercialisé. Galera continuera de faire progresser son inhibiteur pan-NOS principal (L-NMMA/tilarginine) dans un essai multicentrique de phase 2 pour le cancer du sein métaplaste.
Données notables : dans une phase 3 sur 407 patients avec avasopasem, on observe une réduction relative de 16% de la mucosite orale grave (p=0,045) et une réduction de 56% de la durée de la SOM (p=0,002); la FDA a accordé les désignations Fast Track et Breakthrough pour avasopasem.
Galera Therapeutics (OTC: GRTX) hat eine Vermögenswertkaufvereinbarung mit dem in Toronto ansässigen Biossil geschlossen für ihr Dismutase-Mimetika-Portfolio, einschließlich avasopasem und rucosopasem.
Die Bedingungen umfassen eine Voranzahlung von 3,5 Mio. USD sowie regulatorische, kommerzielle und beteiligungsbasierte Zahlungen von insgesamt bis zu 105 Mio. USD. Biossil übernimmt Verpflichtungen aus der Royalty-Vereinbarung von 2018, einschließlich einer 4%-Tantieme, falls eines der Mittel kommerzialisiert wird. Galera wird weiterhin seinen führenden pan-NOS-Inhibitor (L-NMMA/Tilarginin) in einer multizentrischen Phase-2-Studie zum metaplatischen Brustkrebs vorantreiben.
Bemerkenswerte Daten: In einer Phase-3-Studie mit 407 Patienten zu Avsopasem zeigte sich eine relative Reduktion der schweren oralen Mukositis um 16% (p=0,045) und eine Reduktion der SOM-Dauer um 56% (p=0,002); die FDA hat für Avsopasem Fast Track- und Breakthrough-Zulassungen erteilt.
Galera Therapeutics (OTC: GRTX) أبرمت اتفاقية شراء أصول مع Biossil مقرها في تورنتو لـمجموعة مُقلّبات دامجة لـِ انحلال التبادُل/ديسموتاز، بما في ذلك avasopasem و rucosopasem.
تشمل الشروط دفعة مقدمة قدرها 3.5 مليون دولار و< b>مدفوعات تنظيمية وتجارية وشرطية تصل مجتمعة إلى 105 مليون دولار. ستتحمل Biossil الالتزامات بموجب اتفاقية الملكية لعام 2018، بما في ذلك ملكيات قدرها 4% إذا تم تسويق أي من العاملين. ستواصل Galera تقدم مثبِّط pan-NOS الرائد لديها (L-NMMA/ tilarginine) في تجربة المرحلة 2 متعددة المراكز لسرطان الثديMetaplastic.
بيانات ملحوظة: أظهرت تجربة المرحلة 3 لـ avasopasem المكونة من 407 مرضى انخفاضًا نسبياً في حدوث التهاب الفم الشديد بنسبة 16% (p=0.045) وانخفاضًا بنسبة 56% في مدة SOM (p=0.002)؛ منحت FDA تصنيفات Fast Track و Breakthrough لـ avasopasem.
Galera Therapeutics (OTC: GRTX) 已与多伦多的 Biossil 签订资产购买协议，涵盖其 超氧化物歧化酶拟似物药物组合，其中包括 avasopasem 和 rucosopasem。
条款包括一笔 350万美元的前期付款，以及 监管、商业及或有付款合计最高达1.05亿美元。Biossil 将承担 2018 年版税协议下的义务，其中若任一药物商业化，将产生 4% 的特许权使用费。Galera 将继续推进其领先的 pan-NOS 抑制剂（L-NMMA/tilarginine）在一项多中心的 II 期试验中用于去铁/metaplastic 乳腺癌。
值得关注的数据：在 407 例患者的 avasopasem III 期研究中，观察到 重度口腔黏膜炎相对降低 16%（p=0.045），以及 SOM 持续时间降低 56%（p=0.002）；FDA 已为 avasopasem 授予 Fast Track 与 Breakthrough 指导。
- Upfront proceeds of $3.5 million
- Contingent payments and milestones up to $105 million
- Biossil assumes 4% royalty obligations under Royalty Agreement
- Phase 3: 16% relative reduction in severe oral mucositis (p=0.045)
- Phase 3: 56% relative reduction in SOM duration (p=0.002)
- FDA Fast Track and Breakthrough designations for avasopasem
- Immediate cash is modest: only $3.5 million upfront
- Majority of transaction value is contingent on future milestones
- Divestiture transfers avasopasem and rucosopasem commercialization rights away from Galera
Insights
Asset sale shifts dismutase mimetics to Biossil; Galera gains modest upfront cash and removes near-term program obligations.
Galera sold its dismutase mimetics portfolio, including avasopasem and rucosopasem, for an upfront
The business mechanism reduces Galera’s near-term development and commercialization burden for these agents while preserving upside through contingency payments; it also concentrates Galera’s resources on its lead pan‑NOS program (L‑NMMA/tilarginine) now in a multicenter
Watch for: (1) announcements from Biossil on development and financing plans and any near‑term regulatory filings; (2) milestone triggers and timing that would convert contingent value into cash for Galera; and (3) enrollment and readouts from Galera’s pan‑NOS
Galera has entered into an Asset Purchase Agreement with Toronto-based Biossil for Galera’s dismutase mimetics portfolio, including all avasopasem and rucosopasem formulations and indications.
The agreement includes 1) an upfront payment of
Biossil assumes all further obligations to Blackstone Life Sciences under the 2018 Amended and Restated Purchase and Sale Agreement (the Royalty Agreement) for dismutase mimetics products, notably a
Galera’s lead program remains its pan-inhibitor of Nitric Oxide Synthase (NOS), which is in a multicenter Phase 2 trial in metaplastic breast cancer in combination with alpelisib and nab-paclitaxel.
MALVERN, Pa, Oct. 22, 2025 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (OTC: GRTX), a clinical-stage biopharmaceutical company developing novel, proprietary therapeutics targeting cancer, today announced it has entered into an asset purchase agreement with Toronto-based biotech Biossil Inc, a privately held biotechnology company, for the acquisition of Galera’s dismutase mimetics portfolio, including avasopasem and rucosopasem. The agreement includes 1) an upfront payment of
Galera’s lead program remains its pan-inhibitor of Nitric Oxide Synthase (NOS), L-NMMA or tilarginine, licensed from The Methodist Hospital of Houston, Texas (Houston Methodist), which is in a multicenter Phase 2 trial in metaplastic breast cancer in combination with alpelisib and nab-paclitaxel. The trial involved a lead-in to optimize the dose of alpelisib with this combination, which was completed at Houston Methodist, and enrollment is being expanded to two additional sites, the University of Texas MD Anderson Cancer Center and the National Institute of Health Clinical Center.
In a 407-patient randomized double-blind phase 3 trial, avasopasem produced a statistically significant (p=0.045),
The FDA has granted Fast Track and Breakthrough Therapy designations to avasopasem for the reduction of SOM induced by radiotherapy. Dismutase mimetics also have a well-developed mechanistic role in anti-cancer therapeutics in preclinical studies, and Galera completed a pilot trial of avasopasem combined with stereotactic body radiotherapy (SBRT) in patients with locally advanced pancreatic cancer (Taniguchi, Cullen M et al. The Lancet Oncology, Volume 24, Issue 12, 1387 – 1398 December 2023).
“We are very pleased to enter into this agreement, which substantially increases the prospects for bringing avasopasem to patients with cancer,” said Mel Sorensen, M.D., President & CEO of Galera. “Biossil has the expertise and financing capable of advancing avasopasem through the remaining clinical and regulatory hurdles to make it available to patients with cancer. We also believe this transaction serves the best interests of our shareholders, who stand to benefit further should potential regulatory and commercial milestones be achieved. Galera will continue to focus on advancing its pan-NOS inhibitor for patients with advanced breast cancer.”
“We thank the management team at Galera for entrusting Biossil with continued development of avasopasem,” said Dr. Alexander Mosa, M.D., PhD, Chief Scientific Officer, and Chair of Biossil. “Treatments to attenuate toxicity and improve the tolerability of chemoradiotherapy are urgently needed. Biossil will advance avasopasem with rigor commensurate with its clinical promise and the unmet need.”
About Galera Therapeutics
Galera Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on advancing a pan-NOS inhibitor through clinical development for patients with the hardest-to-treat forms of advanced breast cancer. It was historically focused on developing avasopasem, a small molecule dismutase mimetic, in combination with chemoradiotherapy, to reduce the toxicities of the conventional regimens in patients with head and neck cancer.
About Biossil
Biossil is an AI-native drug development company advancing a pipeline of late-stage, first-in-class candidates for heterogeneous and life-threatening diseases. With teams in Toronto and Boston, and partnerships with leading academic medical centers and research hospitals, Biossil integrates proprietary AI with deep clinical and translational expertise to rescue and reposition promising clinical-stage assets.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements concerning future clinical development activities and potential milestone payments.
These forward-looking statements relate to us, our business prospects and our results of operations and are subject to certain risks and uncertainties posed by many factors and events that could cause our actual business, prospects and results of operations to differ materially from those anticipated by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those described under the heading “Risk Factors” included in Galera’s annual report on Form 10-K for the year ended December 31, 2024, and Quarterly Reports on Form 10-Q for the quarters ended March 31 and June 30, 2025. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this report. In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “aim,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. We undertake no obligation to revise any forward-looking statements in order to reflect events or circumstances that might subsequently arise.
These forward-looking statements are based upon our current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation:
- Changes in capital resource requirements;
- Risks related to our inability to obtain sufficient additional capital to continue to advance our product candidates;
- Our and our collaborator’s ability to execute clinical programs for our product candidates;
- Results of clinical trials with our product candidates; and
- Our ability to obtain and maintain intellectual property rights and regulatory exclusivities.
Investor Contact:
Joel Sussman
Galera Therapeutics, Inc.
610-725-1517
jsussman@galeratx.com
FAQ
What did Galera (GRTX) agree to sell to Biossil on October 22, 2025?
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Does Biossil assume any royalty obligations in the Galera (GRTX) sale?
What Phase 3 results for avasopasem were disclosed before the sale of GRTX assets?
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