Scinai Immunotherapeutics Receives Italian Government Clearance Under Golden Power Regulation for Potential Acquisition of Pincell S.r.l.

Rhea-AI Summary

Scinai Immunotherapeutics (NASDAQ: SCNI) has received Italian government clearance under the Golden Power regulation for its potential acquisition of Pincell S.r.l., an Italian biotech company. The approval, granted after review by the Coordination Group and Ministry of Health, removes a major regulatory hurdle for the acquisition planned since March 2025. Pincell's key asset is PC111, a human monoclonal antibody targeting Fas/FasL pathway for severe dermatological conditions, which has received EMA Orphan Drug Designation for Pemphigus. Scinai's Polish subsidiary has applied for a €12 million FENG grant to fund PC111's development, with a decision expected by August 2025. The acquisition's completion remains contingent on successful grant approval and other customary conditions.

Positive

• Received key Italian regulatory clearance for Pincell acquisition, removing major regulatory hurdle
• Target company's lead drug PC111 has EMA Orphan Drug Designation for Pemphigus treatment
• Potential €12 million grant funding from FENG program could support PC111 development

Negative

• Acquisition completion still depends on successful €12 million grant approval
• Additional closing conditions remain to be fulfilled before deal completion

The regulatory approval marks a key milestone toward the potential acquisition of Pincell, removing a major condition precedent under the option agreement and allowing Scinai to advance toward finalizing the transaction, subject to customary remaining conditions.

JERUSALEM, June 5, 2025 /PRNewswire/ -- Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI), a biopharmaceutical company specializing in inflammation and immunology (I&I) biological products and providing CDMO services through its Scinai Bioservices unit, today announced that the Italian government has granted clearance under the Golden Power regulation (Law Decree No. 21/2012) for Scinai's option to acquire 100% of the share capital and voting rights of Pincell S.r.l., an Italian biotechnology company.

This approval was issued following a review by the Coordination Group for the exercise of special powers, based on the outcome of the assessment conducted by the Ministry of Health, the competent authority. The clearance pertains to the transaction as presented in the notification submitted on April 5, 2025, which includes the granting of a license by Pincell and Scinai's Polish subsidiary, Scinai Immunotherapeutics Sp. Z.O.O, for the use of Pincell's intellectual property rights.

"We are pleased to have received this regulatory clearance, which represents a significant step forward in our planned acquisition of Pincell," said Amir Reichman, CEO of Scinai Immunotherapeutics. "While this approval addresses a key regulatory requirement, it does not signify the completion of the transaction. We continue to work diligently to satisfy all remaining conditions necessary to exercise our option and finalize the acquisition."

Scinai entered into a binding option agreement to acquire Pincell in March 2025. Pincell's lead candidate, PC111, is a fully human monoclonal antibody targeting the Fas/FasL pathway, currently in development for treating severe dermatological conditions such as Pemphigus, Stevens-Johnson Syndrome (SJS), and Toxic Epidermal Necrolysis (TEN). PC111 has already received Orphan Drug Designation in Pemphigus by the European Medicines Agency.

In anticipation of the acquisition, Scinai's wholly owned Polish subsidiary submitted a €12 million grant application under the European Funds for a Modern Economy (FENG) program to fund the next stage of PC111's development. An award decision is expected by mid-July to early August 2025.

Completion of the acquisition remains subject to the fulfillment of additional closing conditions, including the successful outcome of the grant application and other customary requirements.

About Scinai Immunotherapeutics

Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) is a biopharmaceutical company with two complementary business units, one focused on in-house development of inflammation and immunology (I&I) biological therapeutic products beginning with an innovative, de-risked pipeline of nanosized VHH antibodies (nanoAbs) targeting diseases with large unmet medical needs, and the other a boutique CDMO providing biological drug development, analytical methods development, clinical cGMP manufacturing, and pre-clinical and clinical trial design and execution services for early stage biotech drug development projects.

Company website: www.scinai.com.

Company Contacts

Investor Relations - Allele Capital Partners | +1 978 857 5075 | aeriksen@allelecapital.com  

Business Development | +972 8 930 2529 | bd@scinai.com

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Litigation Reform Act of 1995. Words such as "expect," "believe," "intend," "plan," "continue," "may," "will," "anticipate," and similar expressions are intended to identify forward-looking statements. All statements, other than statements of historical facts, are forward-looking statements. These forward-looking statements reflect management's current views with respect to certain current and future events and are subject to various risks, uncertainties and assumptions that could cause the results to differ materially from those expected by the management of Scinai Immunotherapeutics Ltd. Risks and uncertainties include, but are not limited to;  the risk that the Company will be unable to satisfy all of the other additional closing conditions to acquire Pincell; that the Company will be unable to  remain compliant with the continued listing requirements of Nasdaq; lower than anticipated revenues of Scinai's CDMO business in 2025 and thereafter; failure to sign agreements with other potential clients of the CDMO business; a delay in the commencement and results of pre-clinical and clinical studies, including the Phase 1/2a study for psoriasis, the risk of delay in, Scinai's inability to conduct, or the unsuccessful results of, its research and development activities, including the contemplated in-vivo studies and a clinical trial; the risk that Scinai will not be successful in expanding its CDMO business or in-license other nanoAbs; the risk that Scinai may not be able to secure additional capital on attractive terms, if at all; the risk that the therapeutic and commercial potential of nanoAbs will not be met or that Scinai will not be successful in bringing the nanoAbs towards commercialization; the risk of a delay in the preclinical and clinical trials data for nanoAbs, if any; the risk that our business strategy may not be successful; Scinai's ability to acquire rights to additional product opportunities; Scinai's ability to enter into collaborations on terms acceptable to Scinai or at all; timing of receipt of regulatory approval of Scinai's manufacturing facility in Jerusalem, if at all or when required; and the risk that drug development involves a lengthy and expensive process with uncertain outcomes. More detailed information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in the Company's Annual Report on Form 20-F filed with the Securities and Exchange Commission ("SEC") on May 7, 2025, and the Company's subsequent filings with the SEC. Scinai undertakes no obligation to revise or update any forward-looking statement for any reason.

View original content:https://www.prnewswire.com/news-releases/scinai-immunotherapeutics-receives-italian-government-clearance-under-golden-power-regulation-for-potential-acquisition-of-pincell-srl-302474330.html

SOURCE Scinai Immunotherapeutics Ltd.

FAQ

What is the significance of the Italian Golden Power clearance for Scinai Immunotherapeutics (SCNI)?

The clearance removes a major regulatory requirement for Scinai's planned acquisition of Pincell S.r.l., allowing the company to proceed with the transaction subject to remaining conditions.

What is Pincell's main product candidate that SCNI aims to acquire?

Pincell's lead candidate is PC111, a human monoclonal antibody targeting Fas/FasL pathway for treating severe dermatological conditions like Pemphigus, Stevens-Johnson Syndrome, and Toxic Epidermal Necrolysis.

What are the remaining conditions for SCNI to complete the Pincell acquisition?

The acquisition depends on securing a €12 million FENG grant (decision expected by August 2025) and fulfilling other customary closing requirements.

What regulatory designation has PC111 received from the European Medicines Agency?

PC111 has received Orphan Drug Designation from the European Medicines Agency for the treatment of Pemphigus.

When did SCNI enter into the option agreement to acquire Pincell?

Scinai entered into a binding option agreement to acquire Pincell in March 2025.