Scinai lets PC111 deal lapse, pursues $5M 2026 CDMO

Scinai ends its PC111 arrangements and redirects capital and management focus to its NanoAb platform and expanding CDMO operations, backed by growing customer orders.

Rhea-AI Filing Summary

Scinai Immunotherapeutics Ltd. (SCNI) reports a strategic shift after its option and license arrangements with PinCell for the preclinical program PC111 expired on August 31, 2026 and terminated according to their terms, with no new extension agreed.

Scinai is reallocating R&D resources toward its NanoAb platform and preserving capital and management capacity to support growth of Scinai Biopharma Services, its CDMO business. The company continues a multi-year NanoAb collaboration with the Max Planck Society and University Medical Center Göttingen, including intradermal and systemic IL‑17 programs. The intradermal IL‑17 psoriasis program is the subject of an application under Poland’s FENG program for approximately €12 million in grant funding. On the CDMO side, Scinai reports approximately $3.1 million of Committed Customer Orders as of August 16, 2026 and is pursuing about $5 million of 2026 CDMO revenue, supported by an expanded clinical manufacturing and CMC program for a U.S.-based biopharmaceutical customer under an existing relationship while a broader definitive agreement is negotiated.

Key Figures

PC111 option expiration date: August 31, 2026 FENG grant amount under evaluation: €12 million Committed Customer Orders: $3.1 million +1 more

4 metrics

PC111 option expiration date August 31, 2026 Expiry of option conditions and termination of related agreements with PinCell

FENG grant amount under evaluation €12 million Prospective grant financing for intradermal IL‑17 psoriasis program

Committed Customer Orders $3.1 million Aggregate value as of August 16, 2026 across Jerusalem and Yavne CDMO facilities

2026 CDMO revenue objective $5 million CDMO revenue Scinai is pursuing for 2026, subject to execution and recognition criteria

Key Terms

NanoAb platform, contract development and manufacturing organization, Committed Customer Orders, VHH antibody fragments, +1 more

5 terms

NanoAb platform medical

"Scinai will now concentrate its R&D resources on its NanoAb platform"

contract development and manufacturing organization financial

"a revenue-generating contract development and manufacturing organization"

A contract development and manufacturing organization (CDMO) is a specialized service provider that helps other companies design, test, produce and package drugs or medical products on a hired basis. Think of it as an outsourced factory and R&D partner that lets a company scale production without building its own plants. Investors watch CDMO relationships because they affect a drug’s time-to-market, manufacturing costs, supply reliability and overall project risk, all of which influence future revenue and valuation.

Committed Customer Orders financial

"Committed Customer Orders represent the aggregate value of signed customer purchase orders"

VHH antibody fragments medical

"The Company’s NanoAb platform uses VHH antibody fragments to support the development"

VHH antibody fragments are the tiny, single-domain binding portion of special antibodies naturally found in camelids; they are often called nanobodies. Like a small key cut from a larger keyring, they retain the part that fits a target molecule while being much smaller and more stable than conventional antibodies, which matters to investors because their size, robustness and simpler production make them attractive for drug development, diagnostics and engineered biologics.

cGMP manufacturing technical

"execute development, scale-up and cGMP manufacturing activities"

cGMP manufacturing stands for "current Good Manufacturing Practice" and describes regulated factory processes and quality checks that ensure drugs, biologics, or medical products are made safely, consistently, and to required purity standards. For investors, cGMP compliance matters because it reduces the risk of product recalls, regulatory shutdowns, or approval delays—similar to a restaurant passing health inspections so customers keep coming back and the business can keep operating.

FAQ

What strategic change did Scinai Immunotherapeutics (SCNI) announce regarding PC111?

Scinai announced that its option and license arrangements with PinCell for the PC111 preclinical program expired on August 31, 2026 and terminated in accordance with their terms, and that it will now concentrate R&D resources on its NanoAb platform and CDMO business.

How is Scinai (SCNI) refocusing its R&D portfolio?

Scinai is concentrating its R&D resources on its NanoAb platform, including intradermal and systemic IL‑17 programs, while preserving capital and management capacity to support growth and execution of its Scinai Biopharma Services CDMO business.

What grant funding is Scinai (SCNI) pursuing for its IL-17 psoriasis program?

Scinai’s intradermal IL‑17 program for psoriasis is under evaluation in Poland’s FENG program for approximately €12 million in grant financing, intended to support development from the preclinical stage through first‑in‑human readiness, with timing and outcome of the review outside Scinai’s control.

What level of CDMO Committed Customer Orders does Scinai (SCNI) report?

As of August 16, 2026, Scinai reports approximately $3.1 million in Committed Customer Orders across its Jerusalem and Yavne facilities, representing the aggregate value of signed purchase orders for specified CDMO services under existing contracts.

What 2026 CDMO revenue objective does Scinai (SCNI) describe?

Scinai states it is pursuing approximately $5 million of CDMO revenue for 2026, subject to project execution, timing, applicable revenue‑recognition criteria and conversion of additional opportunities, and notes these discussions and opportunities are not yet committed orders.

What major CDMO program is Scinai (SCNI) working on for a U.S. customer?

Scinai has begun substantive work on an expanded clinical manufacturing and CMC program for a U.S.-based biopharmaceutical customer, intended to support a planned U.S. regulatory submission and Phase III development, while both parties negotiate a broader definitive agreement.

Does Scinai (SCNI) attribute the PC111 decision to scientific issues?

No. Scinai states the outcome was not driven by any new negative scientific finding regarding PC111, and that it continues to recognize PC111’s therapeutic potential while choosing to concentrate capital and management resources elsewhere.

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Available on EDGAR 09/08/2026 - 09:55 AM Accepted by SEC EDGAR 09/08/2026 - 09:54 AM Learn about SEC filing dates

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16

Under the Securities Exchange Act of 1934

For the Month of September 2026

Commission File Number: 001-37353

SCINAI IMMUNOTHERAPEUTICS LTD.

(Translation of registrant’s name into English)

Jerusalem BioPark, 2nd Floor

Hadassah Ein Kerem Campus

Jerusalem, Israel

(Address of principal executive office)

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.

Form 20-F ☒            Form 40-F ☐

Explanatory Note 

On September 8, 2026, Scinai Immunotherapeutics Ltd. issued a press release titled “Scinai Concludes PC111 Arrangements and Refocuses Capital on NanoAb Platform and Growing CDMO Business.”

A copy of the press release is furnished herewith as Exhibit 99.1.

This Report on Form 6-K is hereby incorporated by reference into the registrant’s Registration Statements on Form S-8 (File Nos. 333-291460, 333-271293 and 333-239344) and Form F-3 (File Nos. 333-295698 and 333-276767), to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.

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Exhibit Index

Exhibit No.		Description
99.1		Press release dated September 8, 2026.

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

	Scinai Immunotherapeutics Ltd.
Date: September 8, 2026	By:	/s/ Amir Reichman
		Amir Reichman
		Chief Executive Officer

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Exhibit 99.1

Scinai Concludes PC111 Arrangements and Refocuses Capital on NanoAb Platform and Growing CDMO Business

Following the conclusion of the PinCell option and license arrangements, Scinai concentrates resources on its NanoAb platform and CDMO commercial execution, without taking on additional PC111 funding commitments

JERUSALEM, September 8, 2026 /PRNewswire/ -- Scinai Immunotherapeutics Ltd. (Nasdaq: SCNI) (“Scinai” or the “Company”), a biopharmaceutical company combining innovative immunology therapeutic development with a revenue-generating contract development and manufacturing organization (“CDMO”), today announced a strategic refocusing of its R&D portfolio following the conclusion of its option and license arrangements with PinCell S.r.l. relating to PC111.

Following discussions between Scinai and PinCell regarding a possible extension, no further agreement was reached. The applicable option conditions expired on August 31, 2026, and the Option Agreement and related License Agreement terminated in accordance with their terms. Scinai will now concentrate its R&D resources on its NanoAb platform while preserving capital and management capacity to support the continued growth and execution of Scinai Biopharma Services, its CDMO business.

The outcome was not driven by any new negative scientific finding regarding PC111. Scinai continues to recognize the therapeutic potential of PC111 and appreciates the collaboration with the PinCell team.

Amir Reichman, Chief Executive Officer of Scinai, commented:

“PC111 remains an interesting and promising preclinical program, and we greatly appreciate our collaboration with Tony Amato and the PinCell team. Following the conclusion of our existing arrangements, our responsibility is to determine where Scinai’s capital and management resources can create the greatest value for shareholders.”

“Advancing any preclinical asset through meaningful de-risking requires substantial capital and time. In the absence of secured grant funding for PC111, continuing our involvement would have required additional investment before there was visibility on non-dilutive financing. At the same time, we already have a multi-program NanoAb platform under our long-term research collaboration with the Max Planck Society and University Medical Center Göttingen as well as significant commercial opportunities emerging within our CDMO business.”

“We therefore believe concentrating our resources on these existing priorities is the appropriate capital-allocation decision for Scinai. It reduces prospective near-term R&D commitments while allowing us to focus on opportunities that we believe can create broader and more durable value for shareholders.”

Prioritizing a Platform with Multiple Development and Partnering Opportunities

Scinai remains committed to its multi-year research collaboration with the Max Planck Society and University Medical Center Göttingen. The Company’s NanoAb platform uses VHH antibody fragments to support the development of mono-, bi- and multi-specific therapeutic formats for inflammatory and immune-mediated diseases.

Management believes the NanoAb platform provides multiple potential development paths from a common technology base, creating opportunities to generate value across several therapeutic programs and potentially pursue partnering and co-development arrangements with pharmaceutical companies. Concentrating resources within this existing platform also supports Scinai’s commitments under its long-term research collaboration and allows the Company to prioritize programs based on scientific progress, differentiation and access to appropriate financing.

Scinai is currently advancing two complementary IL-17 programs within the platform. Its intradermal IL-17 program for psoriasis is the subject of an application currently under evaluation under Poland’s FENG program for approximately €12 million in grant financing, intended to support development from the preclinical stage through first-in-human readiness. An award decision is currently expected following completion of the evaluation process, although the timing and outcome of the grant review remain outside Scinai’s control.

In parallel, Scinai’s systemic IL-17 bispecific program remains an important validation program for the broader NanoAb platform, with in vivo proof-of-concept representing the next major development milestone. The Company is also developing a broader portfolio of mono-, bi- and multi-specific NanoAb candidates.

Scinai intends to continue prioritizing its R&D investments based on scientific data, potential product differentiation, development feasibility and the availability of non-dilutive funding and strategic partnerships.

Aligning Portfolio Focus with CDMO Commercial Momentum

The portfolio refocusing accompanies the commercial progress described in Scinai’s August 24, 2026 announcement of its first-half results. As of August 16, 2026, Committed Customer Orders⁽¹⁾ totaled approximately $3.1 million across the Jerusalem and Yavne facilities. The Company continues to pursue approximately $5 million of CDMO revenue for 2026, subject to project execution, timing, applicable revenue-recognition criteria and conversion of additional opportunities.

Scinai has commenced substantive activities on the previously disclosed expanded clinical manufacturing and chemistry, manufacturing and controls (“CMC”) program for a U.S.-based biopharmaceutical customer. The program is intended to support a planned U.S. regulatory submission and subsequent Phase III clinical development, with potential future expansion into commercial manufacturing. Activities are being performed under an existing contractual relationship, while the parties continue to negotiate a definitive agreement covering the broader scope and commercial terms. Scinai is working toward execution of that agreement in the coming weeks, which, if completed as currently contemplated, is expected to expand the committed scope of the program. Future work packages and any commercial manufacturing remain subject to agreement and the customer’s development and regulatory progress.

The Company is also evaluating inquiries for additional projects of comparable scope. These discussions are potential opportunities, not committed orders. Management believes successful execution of larger customer programs, repeat business and improved facility utilization can support progress toward sustainable CDMO profitability and strengthen the Group’s financial resilience.

“This decision should be viewed in the context of the company we are building,” Mr. Reichman added. “Our priorities are to advance our focused NanoAb portfolio, deliver for our CDMO customers and convert the capabilities of our two-site platform into revenue and improved operating performance. Larger, longer-duration customer programs require dedicated attention and consistent execution. Concentrating our resources where we believe they can create the greatest value is central to our strategy. We appreciate the collaboration with Tony Amato and the PinCell team and wish them continued success with PC111.”

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About Scinai Immunotherapeutics

Scinai Immunotherapeutics Ltd. (Nasdaq: SCNI) is a biopharmaceutical company focused on the development of innovative immunology therapies and the operation of a contract development and manufacturing organization. The Company is developing its NanoAb platform through research collaboration and license arrangements with the Max Planck Society and University Medical Center Göttingen.

Scinai also owns Scinai Biopharma Services Ltd., a CDMO providing development and manufacturing services to biotechnology and pharmaceutical companies through facilities in Jerusalem and Yavne, Israel.

For more information, please visit www.scinai.com.

Company Contacts

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

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

⁽¹⁾ Committed Customer Orders

Committed Customer Orders represent the aggregate value of signed customer purchase orders for specified CDMO services under existing contractual arrangements, including amounts that may already have been invoiced or recognized as revenue. Management uses this supplemental measure as an indicator of customer-authorized activity and anticipated utilization. It is not a GAAP measure, may not be comparable to similarly titled measures used by other companies, and should not be interpreted as future revenue, future cash receipts or future financial performance. Revenue recognition and collection depend on service performance, contractual milestones and applicable accounting criteria; projects may be delayed, modified or remain open for extended periods.

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. These include statements regarding the expected benefits of the Company’s portfolio refocusing; prospective spending, capital preservation and dilution exposure; NanoAb development, milestones and partnering opportunities; the Company’s research collaborations; CDMO growth, customer programs, potential commercial manufacturing, facility utilization and profitability; and the 2026 revenue objective.

These statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially. Such risks include the Company’s ability to secure sufficient financing or non-dilutive funding on satisfactory terms or at all; realize the expected benefits of its portfolio decisions; increase its CDMO revenues as currently contemplated, including from its U.S.-based biopharmaceutical customer; satisfy surviving contractual obligations; regain and maintain compliance with the Nasdaq listing requirements; maintain research and license arrangements; generate supportive preclinical or clinical data; obtain regulatory approvals; secure development partners; negotiate definitive customer agreements; execute development, scale-up and cGMP manufacturing activities; convert orders and opportunities into revenue and cash; increase utilization; and achieve revenue targets or profitability. Other risks include competition and market, regulatory, geopolitical and economic conditions. Additional information appears in the Company’s filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 20-F filed on April 1, 2026. Forward-looking statements speak only as of the date of this press release. Except as required by law, the Company undertakes no obligation to update or revise them.

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Filing Exhibits & Attachments

1 document

Press Releases

• EX-99.1 PRESS RELEASE DATED SEPTEMBER 8, 2026 18.9 KB