Scinai Bets on €12M Grant to Advance Novel Drug for Devastating Skin Diseases

JERUSALEM – March 02, 2026 – In a move that highlights the intricate dance of science and finance in modern drug development, Scinai Immunotherapeutics has submitted a revised application for a €12 million grant to advance a promising new therapy. The non-dilutive funding, sought from the European Funds for the Modern Economy (FENG) SMART Path program, is earmarked for PC111, a potential first-in-class treatment for two severe and debilitating autoimmune skin diseases: pemphigus vulgaris (PV) and the life-threatening Stevens–Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN).

The Jerusalem-based biopharmaceutical company (Nasdaq: SCNI) also announced an amendment to its option agreement to acquire PinCell S.r.l., the Italian firm that owns PC111. This strategic alignment of corporate and funding timelines underscores the high stakes involved as Scinai aims to push its lead therapeutic candidate through human proof-of-concept studies.

A High-Stakes Bet on Non-Dilutive Funding

For a clinical-stage biotech company, securing capital is a constant challenge. Scinai's pursuit of the €12 million grant represents a calculated effort to fund a crucial €15 million R&D program without diluting the value of its shares. Non-dilutive funding, such as government grants, is highly coveted in the industry because it provides a cash infusion without forcing the company to issue new stock, which can diminish the ownership stake of existing shareholders.

This approach is particularly critical for Scinai, which, like many of its peers, operates with a significant cash burn rate. Securing the grant would cover 80% of the project's costs, preserving the company's balance sheet and providing a financial runway to achieve critical clinical milestones. The decision to submit a revised application to the Polish national program suggests a rigorous and competitive process, highlighting the company's persistence after an initial attempt was not selected.

Further demonstrating its strategic prudence, Scinai has renegotiated its option to acquire PinCell. The deadlines for fulfilling the option conditions and exercising the option have been extended to August 31, 2026, and September 30, 2026, respectively. This maneuver cleverly synchronizes the potential acquisition with the grant evaluation timeline, which is expected to take three to four months. It effectively de-risks the acquisition, ensuring that Scinai does not commit to the purchase without a clear path to funding the asset's development.

Targeting a Crucial Pathway in Severe Skin Disorders

At the heart of this financial strategy is PC111, a fully human monoclonal antibody with a novel mechanism of action. The drug is designed to selectively target soluble Fas Ligand (sFasL), a protein implicated in the destructive inflammatory processes of several autoimmune diseases.

This targeted approach is especially significant for the conditions PC111 aims to treat:
* Pemphigus Vulgaris (PV): A rare and painful autoimmune disease where the body's immune system mistakenly attacks proteins in the epidermis, leading to the formation of severe blisters on the skin and mucous membranes. Preclinical studies have shown that PC111 can inhibit this blistering process by neutralizing pathogenic sFasL.
* Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN): A rare but life-threatening condition, almost always triggered by a reaction to medication, that causes the top layer of skin to detach from the lower layers. SJS/TEN has an extremely high mortality rate, and critically, there are no approved therapies specifically for the condition.

Unlike many existing autoimmune treatments that rely on broad immunosuppression, PC111 offers a more refined, non-immunosuppressive approach. By specifically targeting the soluble form of FasL, it aims to block the disease-causing pathway while leaving the membrane-bound form, which is essential for normal immune function, intact. This potential for a superior safety profile is a key differentiator. Robust preclinical data from in vitro and ex vivo human skin models has demonstrated PC111's ability to prevent blister formation and cell death, providing a strong scientific rationale for its advancement into human trials.

Navigating a Landscape of Urgent Unmet Needs

The commercial and clinical opportunity for PC111 is defined by the severe unmet needs of the patients it seeks to help. While the global market for Pemphigus Vulgaris treatments was valued at over $470 million in 2023 and is growing, current options are not without drawbacks. The standard of care, including corticosteroids and the biologic drug rituximab, can have significant side effects associated with broad immunosuppression, including an increased risk of infection.

The case for SJS/TEN is even more stark. With no approved therapies, physicians are left to rely on supportive care and a patchwork of off-label immunomodulatory agents like cyclosporine and etanercept, with varying and unproven efficacy. A therapy that could reliably halt the progression of this devastating condition would be a paradigm shift in emergency and dermatological medicine.

PC111's unique mechanism positions it as a potentially transformative therapy. For PV, it could offer a safer alternative to broad immunosuppressants. For SJS/TEN, it could become the first-ever approved treatment, addressing one of the most critical gaps in modern dermatologic care.

Public Funds and a Dual-Engine Strategy

Scinai's pursuit of the FENG grant also shines a light on the symbiotic relationship between public funding and private innovation in Europe. Programs like FENG's SMART Path are designed to stimulate economic growth by providing capital for high-risk, high-reward R&D projects that the private market might be hesitant to fund alone. A successful grant award would not only be a victory for Scinai but also a case study in how public investment can accelerate the development of solutions for critical health challenges.

The grant is central to Scinai’s dual-engine business model. The company operates a contract development and manufacturing organization (CDMO) unit, which generates service revenue, alongside its internal R&D pipeline. While the CDMO provides a degree of financial stability, advancing a novel drug like PC111 through expensive clinical trials requires substantial investment. The €12 million in non-dilutive funding would bridge that gap, allowing the company's R&D engine to fire on all cylinders.

Amir Reichman, Chief Executive Officer of Scinai, summarized the strategic importance of the move. "The revised submission reflects a structurally strengthened innovation framework and a clearly defined translational pathway through human proof of concept," he stated. "Securing substantial non-dilutive funding at this stage would meaningfully de-risk the PC111 program while maintaining disciplined capital allocation and preserving strategic flexibility." This careful balance of risk, innovation, and capital is the defining feature of Scinai’s path forward as it seeks to bring hope to patients in desperate need of new options.