SCNI News & Events

Scinai Immunotherapeutics 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 SMART Path program. The company's revised application seeks EUR 12M in non-dilutive, non-repayable funding to support a EUR 15M integrated R&D program for PC111 a fully human monoclonal antibody targeting soluble Fas Ligand for the treatment of pemphigus vulgaris and Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis, 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, and the option exercise period extends to September 30.

Scinai Immunotherapeutics announced the publication of a new peer-reviewed article in the Journal of Dermatological Treatment validating the disease-modifying potential of PC111, a first-in-class human anti-Fas Ligand monoclonal antibody. The new publication confirms PC111's ability to prevent blister formation in in vitro, ex vivo, and in vivo humanized models of pemphigus by targeting soluble Fas Ligand, a key effector of keratinocyte apoptosis and acantholysis. Collectively, the data confirms PC111's non-immunosuppressive mode of action: acting locally at the keratinocyte level and downstream of the immune system. In addition to pemphigus, the authors highlight PC111's promise in SJS/TEN, a life-threatening dermatological emergency. By targeting the final step in disease pathology rather than suppressing the immune system, PC111 offers a differentiated, fast-acting, and safer therapeutic profile. Combined, the two indications represent an annual market opportunity exceeding $1B. Subject to Scinai's exercise of its option to acquire Pincell, the two companies plan to advance PC111 through IND-enabling studies and into clinical development. PC111 has already been granted orphan drug designation in the EU, and a similar status will be pursued also in the U.S. The two companies are exploring accelerated approval pathways that could allow market entry within approximately three to four years.Pending a final decision expected in Q3, Scinai may receive up to 80% cost coverage through a EUR15M FENG grant to support development through IND readiness.

Scinai Immunotherapeutics announced that it has entered into a Standby Equity Purchase Agreement with YA II PN, Ltd., a fund managed by Yorkville Advisors Global, LP. Under the terms of the SEPA, Scinai has the right, but not the obligation, to sell up to $10M of its American Depository Shares, each representing 4,000 ordinary shares, to Yorkville at any time during the three-year period following the execution date of the SEPA and following the effectiveness of a registration statement filed with the Securities and Exchange Commission registering the ordinary shares represented by the ADSs issuable pursuant to the SEPA. Sales to Yorkville under the SEPA are subject to a beneficial ownership cap of 9.99% of Scinai's share capital at any one time, along with other restrictions and conditions outlined in the SEPA. The purchase price of the ADSs sold to Yorkville will be at a 3% discount to the lowest daily volume-weighted average price of the ADSs during the three consecutive trading days commencing on the trading day of the delivery of an advance notice by Scinai. Scinai retains full control over the timing and amount of any sales to Yorkville, with no obligation to utilize any of the $10M available under the SEPA. Advances cannot be initiated by Yorkville, and there are no minimum commitments or penalties for non-use. The SEPA imposes no restrictions on Scinai's operating activities or other capital-raising efforts.

Representing 12,091,184,000 ordinary shares.