Processa Pharmaceuticals Provides Portfolio and Business Update
Processa Pharmaceuticals (Nasdaq: PCSA), a clinical-stage pharmaceutical company, has provided significant updates on its product pipeline and business developments. The company has signed a binding term sheet with Intact Therapeutics for PCS12852, potentially worth up to $454 million in milestone payments plus 12% royalties and a 3.5% equity stake.
The company's lead oncology asset, PCS6422 (NGC-Cap), is actively enrolling patients in a Phase 2 study for metastatic breast cancer, with interim analysis expected in H2 2025. For PCS499, Processa is designing a new adaptive pivotal Phase III study for rare kidney diseases and establishing a dedicated subsidiary to enhance strategic flexibility.
In portfolio optimization moves, Processa has terminated the PCS3117 license agreement, while continuing to explore development strategies for PCS11T, their preclinical oncology asset. The company has also strengthened its balance sheet with a $7 million capital infusion.
Processa Pharmaceuticals (Nasdaq: PCSA), un'azienda farmaceutica in fase clinica, ha fornito aggiornamenti importanti sul suo portafoglio prodotti e sugli sviluppi aziendali. La società ha firmato un accordo vincolante con Intact Therapeutics per PCS12852, potenzialmente del valore di 454 milioni di dollari in pagamenti a tappe più il 12% di royalties e una partecipazione azionaria del 3,5%.
Il principale farmaco oncologico dell’azienda, PCS6422 (NGC-Cap), sta reclutando attivamente pazienti in uno studio di Fase 2 per il carcinoma mammario metastatico, con un’analisi intermedia prevista nella seconda metà del 2025. Per PCS499, Processa sta progettando un nuovo studio pivotale adattativo di Fase III per malattie renali rare e sta creando una filiale dedicata per aumentare la flessibilità strategica.
Come parte dell’ottimizzazione del portafoglio, Processa ha terminato l’accordo di licenza per PCS3117, continuando però a esplorare strategie di sviluppo per PCS11T, il loro asset oncologico preclinico. Inoltre, la società ha rafforzato il bilancio con un iniezione di capitale da 7 milioni di dollari.
Processa Pharmaceuticals (Nasdaq: PCSA), una compañía farmacéutica en etapa clínica, ha proporcionado actualizaciones significativas sobre su cartera de productos y desarrollos comerciales. La empresa ha firmado una hoja de términos vinculante con Intact Therapeutics para PCS12852, con un valor potencial de hasta 454 millones de dólares en pagos por hitos, además de un 12% en regalías y una participación accionaria del 3,5%.
El principal activo oncológico de la compañía, PCS6422 (NGC-Cap), está reclutando activamente pacientes en un estudio de Fase 2 para cáncer de mama metastásico, con un análisis intermedio esperado en la segunda mitad de 2025. Para PCS499, Processa está diseñando un nuevo estudio pivotal adaptativo de Fase III para enfermedades renales raras y estableciendo una subsidiaria dedicada para mejorar la flexibilidad estratégica.
Como parte de la optimización del portafolio, Processa ha terminado el acuerdo de licencia para PCS3117, mientras continúa explorando estrategias de desarrollo para PCS11T, su activo oncológico preclínico. La empresa también ha fortalecido su balance con una inyección de capital de 7 millones de dólares.
Processa Pharmaceuticals (나스닥: PCSA)는 임상 단계의 제약회사로서 제품 파이프라인 및 사업 개발에 관한 중요한 업데이트를 제공했습니다. 회사는 Intact Therapeutics와 PCS12852에 대한 구속력 있는 조건서를 체결했으며, 이는 최대 4억 5,400만 달러의 마일스톤 지급금과 12%의 로열티, 3.5%의 지분 참여가 포함될 수 있습니다.
회사의 주요 종양학 자산인 PCS6422 (NGC-Cap)는 전이성 유방암에 대한 2상 임상시험에서 환자를 적극 모집 중이며, 중간 분석은 2025년 하반기에 예정되어 있습니다. PCS499의 경우, Processa는 희귀 신장 질환을 위한 새로운 적응형 3상 결정적 시험을 설계하고 전략적 유연성을 높이기 위해 전용 자회사를 설립하고 있습니다.
포트폴리오 최적화 차원에서 Processa는 PCS3117 라이선스 계약을 종료했으며, 전임상 종양학 자산인 PCS11T의 개발 전략을 계속 모색하고 있습니다. 또한 회사는 700만 달러의 자본 확충으로 재무구조를 강화했습니다.
Processa Pharmaceuticals (Nasdaq : PCSA), une société pharmaceutique en phase clinique, a fourni des mises à jour importantes sur son portefeuille de produits et ses développements commerciaux. L’entreprise a signé une feuille de conditions contraignante avec Intact Therapeutics pour PCS12852, pouvant valoir jusqu’à 454 millions de dollars en paiements d’étapes, plus 12 % de redevances et une participation au capital de 3,5 %.
L’actif principal en oncologie de la société, PCS6422 (NGC-Cap), recrute activement des patients dans une étude de phase 2 sur le cancer du sein métastatique, avec une analyse intermédiaire prévue au second semestre 2025. Pour PCS499, Processa conçoit une nouvelle étude pivot adaptative de phase III pour les maladies rénales rares et crée une filiale dédiée afin d’améliorer la flexibilité stratégique.
Dans le cadre de l’optimisation de son portefeuille, Processa a mis fin à l’accord de licence pour PCS3117, tout en continuant à explorer des stratégies de développement pour PCS11T, son actif oncologique préclinique. La société a également renforcé son bilan avec une injection de capital de 7 millions de dollars.
Processa Pharmaceuticals (Nasdaq: PCSA), ein Pharmaunternehmen in der klinischen Entwicklungsphase, hat bedeutende Updates zu seiner Produktpipeline und Geschäftsentwicklungen veröffentlicht. Das Unternehmen hat ein verbindliches Term Sheet mit Intact Therapeutics für PCS12852 unterzeichnet, das potenziell bis zu 454 Millionen US-Dollar an Meilensteinzahlungen sowie 12% Lizenzgebühren und eine 3,5%ige Beteiligung umfasst.
Der führende Onkologie-Wirkstoff des Unternehmens, PCS6422 (NGC-Cap), rekrutiert aktiv Patienten für eine Phase-2-Studie bei metastasiertem Brustkrebs, mit einer Zwischenanalyse, die für das zweite Halbjahr 2025 erwartet wird. Für PCS499 plant Processa eine neue adaptive Phase-III-Pivotalstudie für seltene Nierenerkrankungen und gründet eine eigene Tochtergesellschaft, um die strategische Flexibilität zu erhöhen.
Im Zuge der Portfolio-Optimierung hat Processa die Lizenzvereinbarung für PCS3117 beendet, während weiterhin Entwicklungsstrategien für PCS11T, den präklinischen Onkologie-Wirkstoff, geprüft werden. Zudem hat das Unternehmen seine Bilanz mit einer Kapitalspritze von 7 Millionen US-Dollar gestärkt.
- Secured potential $454M milestone payment deal with Intact Therapeutics for PCS12852, including 12% royalties and 3.5% equity stake
- Strengthened balance sheet with $7M capital infusion
- FDA allowing surrogate endpoints for PCS499 in rare kidney diseases, enabling faster development pathway
- Active enrollment in Phase 2 study for lead oncology asset PCS6422
- Strategic portfolio optimization to focus resources on highest-potential programs
- Terminated license agreement for PCS3117 due to high development costs
- PCS11T remains in preclinical stage with undefined development strategy
- Additional patient enrollment needed for PCS6422 Phase 2 interim analysis
Insights
Processa's strategic realignment focuses resources on lead cancer assets while monetizing non-core programs, strengthening finances with $7M infusion.
Processa's comprehensive update reveals a strategic pipeline restructuring aimed at focusing resources on programs with higher probability of success, particularly in oncology. The company has strengthened its balance sheet with a
The company is making significant progress with its lead asset PCS6422 (NGC-Cap) for metastatic breast cancer, which is actively enrolling in Phase 2 trials with interim data expected in H2 2025. Early signals suggest improved tolerability and increased exposure to active cancer-killing metabolites, potentially differentiating it from standard capecitabine therapy.
A major value-creating transaction involves PCS12852, with Intact Therapeutics signing a binding term sheet for an exclusive licensing option. This deal could yield up to
For PCS499, management is establishing a dedicated subsidiary and designing a new adaptive Phase III study in kidney disease, leveraging FDA's acceptance of surrogate endpoints in rare kidney disorders. This restructuring enhances flexibility for targeted capital raising and partnership opportunities.
The company has made the prudent decision to terminate its PCS3117 license agreement after cost-benefit analysis determined advancement would require excessive resources relative to potential return. This strategic pipeline pruning allows for more focused allocation of capital to assets with clearer regulatory and commercial pathways.
- Signed binding term sheet granting Intact Therapeutics an exclusive option to license PCS12852
- Continue enrolling patients in Phase 2 study of PCS6422
- Strengthened balance sheet with
$7M capital infusion
VERO BEACH, Fla., July 01, 2025 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA), a clinical-stage pharmaceutical company developing next-generation cancer therapies, provides updates on its product pipeline, upcoming milestones and business activities.
“We are taking deliberate steps to focus our resources on programs with the highest potential for clinical success and commercial impact,” said Dr. David Young, President Research and Development at Processa. “Our approach continues to center on developing safer, more effective treatments for cancer while creating value through strategic business development and disciplined pipeline management.”
“Our NGC-Cap Phase 2 clinical trial in metastatic breast cancer is actively enrolling patients. We continue to anticipate sharing initial data in the second half of 2025,” said George Ng, Chief Executive Officer of Processa Pharmaceuticals. “The streamlining of our development pipeline, signing of strategic partnerships, and optimizing our capital allocation, enable us to make the necessary investments in our science in order to enhance shareholder value.”
Key Portfolio Updates:
- PCS6422 (NGC-Cap): PCS6422, Processa’s lead oncology asset in combination with capecitabine (NGC-Cap), is actively enrolling patients in a Phase 2 study for metastatic breast cancer. The program remains a top priority, with the remaining patients needed for the pre-planned interim analysis expected to be enrolled in the second half of 2025. The trial builds on compelling safety and efficacy signals observed in earlier studies, including improved tolerability and increased exposure to active cancer-killing metabolites.
- PCS499: Based on preliminary positive results in kidney disease and the FDA allowing surrogate endpoints to now be used in rare kidney diseases, Processa is currently designing a new adaptive pivotal PCS499 Phase III study to discuss with the FDA later this year. In addition, Processa is establishing a dedicated subsidiary to hold PCS499. The move is intended to enhance strategic flexibility in targeting capital raising and potential partnership exploration after meeting with the FDA.
- PCS12852: As previously announced, Processa has signed a binding term sheet with Intact Therapeutics, Inc. granting an exclusive option to license PCS12852 for gastroparesis and related gastrointestinal motility disorders. Under the terms, Processa is eligible for up to
$454 million in milestone payments, a12% royalty on future sales, and a3.5% equity stake in Intact. The partnership represents a strategic monetization of non-core assets while maintaining upside potential. - PCS11T: PCS11T is Processa’s preclinical oncology asset based on the active metabolite of irinotecan. The company continues to define and explore preclinical and clinical development strategies as well as opportunities to support future development.
- PCS3117: After determining that the time and cost required to advance PCS3117 to a meaningful milestone would be too high, Processa has terminated the license agreement for PCS3117 and returning the rights to the original licensor.
Commitment to Shareholder Value
These portfolio changes align with Processa’s strategic intent to focus on oncology assets with strong differentiation, scientific rationale, commercial opportunity and clear regulatory pathways. The company believes this will optimize our human and capital resources, expedite the unlocking of hidden asset value through partnerships, and position the organization to deliver long-term shareholder returns.
Investor Webinar
Processa CEO George Ng will participate in a live investor webinar on Wednesday, July 9, 2025, at 4:15 p.m. ET to discuss the company’s strategic pipeline realignment and value-creating milestones.
To register for the free webinar, please visit: https://www.redchip.com/webinar/PCSA/85765532754
Questions can be pre-submitted to PCSA@redchip.com or online during the live event.
About Processa Pharmaceuticals, Inc.
Processa is a clinical-stage pharmaceutical company focused on developing the Next Generation Cancer (NGC) drugs with improved safety and efficacy. Processa’s NGC drugs are modifications of existing FDA-approved oncology therapies resulting in an alteration of the metabolism and/or distribution of these drugs while maintaining the existing mechanisms of killing the cancer cells. By combining its novel oncology pipeline with proven cancer-killing active molecules and its Regulatory Science Approach, Processa’s strategy is to develop more effective therapy options with improved tolerability for cancer patients through an efficient regulatory path. In addition to its core oncology programs, Processa is actively pursuing strategic partnerships for non-oncology assets to unlock additional value
For more information, visit our website at www.processapharma.com.
Forward-Looking Statements
This release contains forward-looking statements. The statements in this press release that are not purely historical are forward-looking statements which involve risks and uncertainties. Actual future performance outcomes and results may differ materially from those expressed in forward-looking statements. Please refer to the documents filed by Processa Pharmaceuticals with the SEC, specifically the most recent reports on Forms 10-K and 10-Q, which identify important risk factors which could cause actual results to differ from those contained in the forward-looking statements.
Company Contact:
Patrick Lin
(925) 683-3218
plin@processapharma.com
Investor Relations:
Dave Gentry
RedChip Companies, Inc.
1-407-644-4256
PCSA@redchip.com
FAQ
What are the key terms of Processa Pharmaceuticals' (PCSA) deal with Intact Therapeutics?
What is the status of PCSA's Phase 2 trial for PCS6422 in metastatic breast cancer?
How much capital did Processa Pharmaceuticals raise in their recent financing?
What are PCSA's plans for PCS499 development?
Why did Processa Pharmaceuticals terminate the PCS3117 program?
When is Processa's next investor webinar scheduled?
