Scinai Immunotherapeutics secures Italian approval to advance Pincell acquisition and PC111 development

Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI), the Jerusalem-based biopharmaceutical company focused on immunology and inflammation, has received formal clearance from the Italian government under the Golden Power regulation, a critical regulatory milestone in its proposed acquisition of Italian biotech innovator Pincell S.r.l. The approval removes a key condition precedent from the acquisition path, bringing Scinai closer to executing its option to take over 100% of Pincell’s share capital and voting rights.

The Golden Power clearance, which falls under Italy’s Law Decree No. 21/2012, was granted after a review by the Coordination Group for the exercise of special powers and based on an assessment by Italy’s Ministry of Health. The clearance confirms that the Italian authorities do not oppose the foreign acquisition of Pincell, whose research assets include a novel monoclonal antibody candidate for rare dermatological diseases.

This regulatory greenlight, dated June 5, 2025, pertains to Scinai’s formal notification submitted on April 5, 2025. It also covers licensing arrangements involving Pincell and Scinai’s Polish subsidiary, Scinai Immunotherapeutics Sp. Z.O.O, allowing the latter to utilize Pincell’s intellectual property in future clinical development work.

What is the Golden Power regulation and why it matters in the Scinai–Pincell deal

Italy’s Golden Power regulation is designed to protect national strategic interests in critical sectors such as health, defense, and infrastructure. It empowers the government to block or condition foreign investments if they are deemed to pose a risk to national interests. Biotech transactions, particularly those involving innovative therapies or sensitive IP, often fall within the scope of this oversight.

Scinai’s receipt of Golden Power clearance is therefore more than just procedural—it signals that the Italian government views the transaction as compliant with public health and national interest safeguards. In terms of deal timing and execution, this approval was one of the largest regulatory hurdles in finalizing the acquisition agreement signed between Scinai and Pincell in March 2025.

Pincell’s lead asset PC111 targets life-threatening dermatological disorders

At the center of this acquisition is Pincell’s first-in-class biologic candidate PC111, a fully human monoclonal antibody targeting the Fas/FasL pathway. This signaling pathway plays a central role in programmed cell death and immune regulation, and is implicated in severe autoimmune skin conditions.

PC111 is currently in preclinical development for the treatment of Pemphigus vulgaris, Stevens-Johnson Syndrome (SJS), and Toxic Epidermal Necrolysis (TEN)—all of which are rare, life-threatening skin diseases with limited existing therapies. The European Medicines Agency has already granted Orphan Drug Designation to PC111 for its potential use in Pemphigus, reflecting its high unmet clinical need and strategic development value.

Analysts and biotech observers regard Fas/FasL inhibition as a scientifically validated yet underexploited approach in rare autoimmune dermatology, adding upside potential to PC111’s development roadmap.

European grant application may fund PC111’s next development stage

To help finance the next phase of PC111’s development, Scinai’s wholly owned Polish subsidiary has applied for a €12 million non-dilutive grant under the European Funds for a Modern Economy (FENG) program. The FENG initiative supports innovation and technology development across the European Union and provides crucial early-stage funding to biotech ventures pursuing breakthrough therapies.

The grant application, submitted in conjunction with Pincell’s technology, could provide essential resources to support IND-enabling studies and the launch of Phase 1/2a clinical trials in Europe. A final decision on the grant is expected between mid-July and early August 2025. Institutional sentiment around the deal is expected to shift positively if the grant is awarded, as it would de-risk a portion of the clinical program’s capital expenditure.

While the Golden Power clearance is a key win, the acquisition remains contingent on successful grant funding and the satisfaction of other customary closing conditions.

Scinai’s dual business model positions it to capitalize on niche biologics

Scinai Immunotherapeutics operates a dual model combining drug development and boutique CDMO services. On the therapeutics side, the Israeli biopharma firm is advancing a pipeline of nanosized VHH antibodies—also known as nanoAbs—targeting inflammation and immune-mediated diseases. These proprietary molecules are derived from camelid antibodies and offer potential advantages in tissue penetration and manufacturing scalability.

Alongside its proprietary pipeline, Scinai runs a boutique contract development and manufacturing organization (CDMO) through Scinai Bioservices. This unit provides GMP manufacturing, assay development, and clinical trial design services for early-stage biologics, positioning the firm to diversify its revenue and reduce risk exposure tied to a single R&D pipeline.

The planned acquisition of Pincell aligns strategically with Scinai’s nanoAb platform and adds a complementary monoclonal antibody modality targeting different immunological mechanisms.

Investor sentiment and strategic outlook as deal nears execution

Scinai’s NASDAQ-listed stock (SCNI) has remained relatively stable in recent months, reflecting both investor caution around biotech dealmaking and the capital-intensive nature of rare disease drug development. However, receipt of regulatory clearance from Italy is likely to be interpreted as a strong signal that the transaction is on track, especially if accompanied by positive grant funding outcomes in the coming weeks.

Industry sentiment toward monoclonal antibody acquisitions has remained resilient despite broader sectoral volatility. Institutional investors tracking the rare disease market are particularly focused on early-stage programs with regulatory advantages such as Orphan Drug status and European grant eligibility—both of which are applicable in Scinai’s case.

Looking ahead, successful completion of the acquisition, combined with grant support and regulatory milestones, could enable Scinai to initiate first-in-human trials for PC111 by early 2026.

Scinai continues to de-risk pipeline while expanding geographic footprint

The Pincell deal also highlights Scinai’s ongoing strategy to expand its clinical and operational presence across Europe. By anchoring development of PC111 through its Polish subsidiary and leveraging non-dilutive EU funding, Scinai is strategically positioning itself to mitigate cost pressures while gaining regulatory proximity to EMA pathways.

The firm’s CDMO business continues to operate out of Jerusalem, where Scinai has submitted filings to gain GMP certification for broader commercial capabilities. If approved, the manufacturing site could serve as a production hub not only for internal pipeline products but also for external clients within the CDMO network.

In the broader biotech landscape, Scinai’s model of blending proprietary R&D with contract development services mirrors recent trends observed among niche immunology-focused firms in Europe and Israel. The company’s ability to manage risk while advancing high-science therapeutics remains a key factor in how institutional investors will price future value.