Scinai Signs Second Amendment to PinCell Option Agreement and Submits Revised Euro12 Million Non-Dilutive FENG Application to Advance PC111 Through Human Proof of Concept
MWN-AI** Summary
Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) has successfully executed a Second Amendment to its Binding Option Agreement with PinCell S.r.l. and has submitted a revised application under the European Funds for the Modern Economy (FENG) SMART Path program. The revised application seeks €12 million in non-dilutive funding to support a €15 million research and development initiative for Scinai's leading candidate, PC111. This fully human monoclonal antibody is designed to target soluble Fas Ligand (sFasL) for the treatment of autoimmune diseases such as pemphigus vulgaris (PV) and Stevens–Johnson Syndrome (SJS)/Toxic Epidermal Necrolysis (TEN), which currently have no approved therapies.
The amended terms extend the option conditions deadline to August 31, 2026, and the exercise period to September 30, 2026, aligning the acquisition process with the grant evaluation timeline. This strategic move allows Scinai to preserve financial flexibility while pursuing early clinical development of PC111, thereby minimizing shareholder dilution.
The management team believes the revised application's structural enhancements will significantly bolster the project's competitiveness under FENG criteria. It sets the stage for a milestone-driven framework that aims to generate comprehensive datasets for progression decisions in clinical trials.
If awarded the €12 million grant, Scinai will be better positioned to complete early clinical development phases and secure proof of concept for PC111, which targets critical unmet medical needs in severe dermatologic conditions. CEO Amir Reichman emphasized the potential impact of securing this funding on de-risking the program while maintaining prudent capital management.
Scinai Immunotherapeutics continues to focus on developing innovative therapies while managing risks in their operations and is poised for significant advancements in immunology and biopharmaceuticals.
MWN-AI** Analysis
Scinai Immunotherapeutics (NASDAQ: SCNI) has made significant strides by signing a Second Amendment to its PinCell Option Agreement and submitting a revised €12 million application under the European Funds for the Modern Economy (FENG) program. This strategic move signals potential growth opportunities for Scinai and necessitates close market attention.
The revised application focuses on financing research and development for PC111, a monoclonal antibody aimed at treating severe autoimmune conditions that currently lack effective therapies. The €12 million grant—if approved—will support Scinai in completing early clinical development phases while maintaining financial stability and minimizing shareholder dilution. This is particularly favorable for investors, as it indicates prudent capital allocation and strategic foresight.
The extended timelines within the amendment also align well with the funding review process, giving Scinai a solid timeframe (until September 30, 2026) to meet the necessary conditions for the acquisition of PinCell. Such foresighted planning may enhance investor confidence in Scinai’s operational execution and its eventual market positioning.
Moreover, Scinai's focus on developing PC111 could appeal to investors interested in high-risk, high-reward biotech ventures. The potential for accelerated regulatory pathways due to PC111 targeting severe orphan diseases amplifies this appeal, given the substantial unmet medical need in these areas.
However, investors should remain cautious. While the revised application and the hope of receiving non-dilutive funding are positive, the inherent risks associated with clinical development, regulatory approvals, and funding uncertainties remain significant.
In summary, Scinai's recent actions reflect a comprehensive strategy that enhances its potential for growth and stability. Investors should keep a close eye on the outcomes of the FENG application and overall developments surrounding PC111, as these will likely influence the stock's performance in the near future.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
PR Newswire
JERUSALEM, March 2, 2026 /PRNewswire/ -- Scinai Immunotherapeutics Ltd. (Nasdaq: SCNI);("Scinai" or the "Company"), today announced the execution of a Second Amendment to its Binding Option Agreement for the acquisition of PinCell S.r.l., and the submission of a revised application under the European Funds for the Modern Economy (FENG) SMART Path program.
The Company's revised application seeks €12 million in non-dilutive, non-repayable funding to support a €15 million integrated R&D program for PC111 a fully human monoclonal antibody targeting soluble Fas Ligand (sFasL) for the treatment of pemphigus vulgaris (PV) and Stevens–Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN), representing 80% project co-financing. The Company expects a funding decision within approximately three to four months following submission.
The Second Amendment aligns the option timeline with the grant evaluation process. Under the amended terms, the deadline for fulfillment of the option conditions extends to August 31, 2026, and the option exercise period extends to September 30, 2026.
Strengthened and Repositioned Application
The Company has submitted a revised application under the SMART Path program reflecting structural enhancements to project design and translational scope. The updated submission advances PC111 through a milestone-driven framework culminating in integrated non-clinical and First-in-Human datasets intended to support data-driven progression decisions. Management believes the revised structure enhances the project's competitiveness under program criteria.
Strategic Financing Catalyst
If awarded, the €12 million grant would enable Scinai to advance PC111 through completion of early clinical development and human proof of concept while preserving balance sheet flexibility and minimizing shareholder dilution.
PC111 is a first-in-class therapeutic candidate for severe autoimmune blistering diseases, including pemphigus vulgaris (PV) and Stevens–Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN). There are currently no approved therapies for SJS/TEN.
Subject to clinical results and regulatory engagement, management believes PC111 may qualify for accelerated regulatory pathways in severe orphan dermatologic indications given the high unmet medical need.
"The revised submission reflects a structurally strengthened innovation framework and a clearly defined translational pathway through human proof of concept," said Amir Reichman, Chief Executive Officer of Scinai. "Securing substantial non-dilutive funding at this stage would meaningfully de-risk the PC111 program while maintaining disciplined capital allocation and preserving strategic flexibility."
About Scinai Immunotherapeutics
Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) is a biopharmaceutical company operating a contract development and manufacturing organization (CDMO) alongside a focused immunology R&D pipeline.
The Company's wholly owned CDMO unit provides fee-for-service development and manufacturing solutions to biotech and pharmaceutical companies across early-stage biologics and small-molecule programs. In parallel, Scinai is advancing a focused immunology pipeline, including PC111 and next-generation NanoAb-based programs, and is pursuing strategic partnerships, co-development agreements and regional licensing opportunities.
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 U.S. Private Securities Litigation Reform Act of 1995 and other applicable securities laws. Forward-looking statements include, among other things, statements regarding the planned submission and anticipated review timeline of the revised FENG grant application; the potential award, amount and non-dilutive nature of funding under the European Funds for the Modern Economy (FENG) SMART Path program; the Company's ability to satisfy the conditions for and exercise its option to acquire PinCell S.r.l.; the expected scope, timing and outcomes of the PC111 development program, including completion of early clinical studies and generation of translational evidence; the potential eligibility of PC111 for accelerated regulatory pathways; and the Company's strategic and capital allocation plans. Words such as "expects," "intends," "plans," "believes," "may," "will," "anticipates," "estimates," "targets," and similar expressions are intended to identify forward-looking statements.
These statements are based on current expectations and assumptions and are subject to a number of risks, uncertainties and other factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, without limitation: the risk that the FENG grant application is not approved, is approved in a lower amount than anticipated, or is subject to conditions that delay, limit or prevent access to funding; delays in grant review or disbursement timelines; the Company's ability to secure alternative financing required under the option agreement if grant funding is not obtained; the risk that the Company does not satisfy the conditions for, or otherwise does not, exercise the option to acquire PinCell; risks inherent in preclinical and clinical development, including delays in or unsuccessful results from studies of PC111; regulatory risks, including the risk that accelerated or other expedited pathways may not be available; risks relating to intellectual property protection; the Company's ability to maintain compliance with Nasdaq continued listing requirements; risks associated with the Company's need for additional capital; and general market and economic conditions.
More detailed information regarding these and other risks and uncertainties is included under the heading "Risk Factors" in the Company's Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission on May 7, 2025, and in the Company's subsequent filings with the SEC.
Forward-looking statements speak only as of the date of this press release. Except as required by applicable law, the Company undertakes no obligation to update or revise any forward-looking statements to reflect new information, future events, or otherwise.
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SOURCE Scinai Immunotherapeutics Ltd.
FAQ**
How does the execution of the Second Amendment to the PinCell Option Agreement align with Scanner Technologies Corp SCNI's strategic goals for the ongoing development of PC111?
What specific enhancements were made to the revised €12 million FENG application submitted by Scanner Technologies Corp SCNI, and how do these improvements strengthen the project's competitiveness?
Can Scanner Technologies Corp SCNI elaborate on the expected impact of securing the €12 million non-dilutive funding on its financial flexibility and capital allocation strategy?
What are the key milestones that Scanner Technologies Corp SCNI aims to achieve with PC111 during the early clinical development phase, and how does the company plan to meet regulatory requirements for potential accelerated pathways?
**MWN-AI FAQ is based on asking OpenAI questions about Scanner Technologies Corp (NASDAQ: SCNI).
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