Scinai Expands CDMO Business with $5.1 Million Development and Clinical Manufacturing Agreement

Advance and milestone payments are expected to support cash flow and working capital during project execution.

Rhea-AI Summary

Scinai Immunotherapeutics (SCNI) signed a development and clinical manufacturing agreement through its subsidiary with approximately $5.1 million in committed base service fees. The U.S.-based, Nasdaq-listed customer is expanding an existing engagement for an investigational oncology product. Fees are subject to performance and contractual termination rights. Scinai expects revenue contributions in 2026 and 2027, with clinical manufacturing planned to begin in January 2027 and stability services continuing beyond 2027.

Committed Customer Orders reached approximately $7.6 million, up approximately 300% from $1.9 million at year-end 2025 and more than double August 16, 2026 levels. Potential additional manufacturing carries an indicative, uncommitted $5.85 million service-fee value for late 2027 through the first half of 2028, subject to scope, pricing, authorization, capacity and customer progress.

8 points · 1 major

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0 major · 4 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Major pointApproximately $5.1 million in committed base service fees expands an existing customer engagement. 6.5× market cap
• Moderate pointCommitted Customer Orders reached approximately $7.6 million, up approximately 300% from year-end 2025 and more than double August 16, 2026 levels. 9.7× market cap
• Moderate point. Forward-looking: it has not happened yet and may not happen.Potential additional manufacturing carries an indicative, uncommitted $5.85 million service-fee value for late 2027 through first-half 2028. 7.4× market cap
• Minor point. Forward-looking: it has not happened yet and may not happen.Revenue contributions are expected in 2026 and 2027 as performance obligations are satisfied.
• Minor point. Forward-looking: it has not happened yet and may not happen.Advance and milestone payments are expected to support project cash flow and working capital.

3 minor points

• Minor point. Forward-looking: it has not happened yet and may not happen.Clinical manufacturing is planned to begin in January 2027; stability services continue beyond 2027.
• Minor point. Forward-looking: it has not happened yet and may not happen.Separately billed approved project costs, including applicable procurement and handling charges, are expected to generate additional revenue.
• Minor point. Forward-looking: it has not happened yet and may not happen.Future commercial manufacturing is a potential opportunity arising from the customer relationship.

Negative

• Minor pointCommitted service fees remain subject to performance, agreement terms and applicable termination rights.
• Minor pointAdditional manufacturing requires final scope and pricing, written authorization, available capacity, and customer development and regulatory progress.
• Minor point. Forward-looking: it has not happened yet and may not happen.Commercial manufacturing depends on customer clinical and regulatory progress, manufacturing requirements and a separate commercial agreement.
• Minor point. Forward-looking: it has not happened yet and may not happen.Project-cost revenue recognition may differ from total customer billings under applicable accounting requirements.

News Explained

Separate project-cost billings add expected revenue beyond the committed service fee, while the $7.6 million order figure is not revenue or remaining backlog.

The signed agreement also requires Scinai to bill approved project-related costs separately from the $5.1 million service commitment; the company expects those charges to generate additional revenue, though recognized revenue may differ from billings.

The $7.6 million Committed Customer Orders figure is a supplemental operating measure, not GAAP revenue or remaining unfulfilled backlog, and does not guarantee future revenue or cash receipts.

The $5.85 million indicative value covers potential clinical manufacturing service fees but excludes scale-up, manufacturing-suite transition and qualification, and the first clinical batch in the new configuration, for which pricing is not established.

Potential commercial manufacturing remains subject to the customer's clinical and regulatory progress, manufacturing requirements and a separate agreement; no supply volumes or related revenue are committed.

Argus 15 min delay 58 alerts

+88.79% vs previous close $2.19 last price 5568.1x rel. volume Open Argus

Details

Market move: SCNI +88.79% vs previous close. CDMO manufacturing agreement

+162.2% Peak in 3 min

$1.04 – $3.33 Day Range

$1.48M Market Cap

On Oct 13, the day this news came out, the latest delayed price for SCNI is 88.79% above the previous close. Argus tracked a peak move of +162.2% during the session. Our momentum scanner has recorded 58 alerts for this stock so far that day. The latest delayed price is $2.19. Relative volume is exceptionally heavy at 5568.1x the average.

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Key Figures

Committed base service fees: $5.1 million Committed Customer Orders: Approximately $7.6 million Committed Customer Orders increase: Approximately 300% +1 more

Committed base service fees

$5.1 million

Subject to performance and the agreement's terms, including applicable termination rights

Committed Customer Orders

Approximately $7.6 million

Across Jerusalem and Yavne operations following execution

Committed Customer Orders increase

Approximately 300%

From $1.9 million at year-end 2025

Potential additional service fees

$5.85 million

Indicative and uncommitted; activities contemplated for late 2027 through the first half of 2028

Historical Context

1 past event · Latest: Sep 08

1 event

1. Sep 08

   CDMO agreement negotiations

   24h Move

   -9.1%

   Reported $3.1 million in orders and ongoing negotiations for a broader definitive U.S. customer agreement.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

cdmo, cmc, ind-enabling, gaap

4 terms

cdmo technical

"contract development and manufacturing organization ("CDMO")"

A contract development and manufacturing organization (CDMO) is a company that provides specialized services to help develop and produce pharmaceutical products for other businesses. Think of it as a contract factory that takes a company's recipe and makes the product on their behalf. For investors, CDMOs are important because they support the growth of pharmaceutical companies and can be key partners in bringing new medicines to market.

cmc technical

"integrated chemistry, manufacturing and controls ("CMC") development"

Chemistry, Manufacturing, and Controls (CMC) describes the technical documentation and processes that show how a drug or medical product is made, tested for consistent quality, and kept stable from batch to batch. Investors care because strong CMC means a product can be manufactured reliably at scale and meet regulatory standards—similar to proving a recipe can be cooked the same way in any kitchen before restaurants expand—affecting approval, production costs, and potential revenue.

ind-enabling regulatory

"manufacturing readiness, IND-enabling activities"

Ind-enabling describes the preclinical tests and safety work a drug candidate must pass before a company can ask regulators for permission to start human trials (an Investigational New Drug or IND filing). Think of it as the mechanical inspection and crash-testing a prototype car needs before it can legally be driven on public roads; for investors, successful ind-enabling work reduces technical and regulatory risk and makes clinical progress and potential value creation more likely.

gaap financial

"It is not calculated under GAAP"

GAAP, or Generally Accepted Accounting Principles, are a set of standardized rules and guidelines that companies follow when preparing their financial statements. They ensure consistency, transparency, and comparability across different companies, making it easier for investors to understand and compare financial information accurately. This helps investors make informed decisions based on trustworthy and uniform financial reports.

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Committed Customer Orders¹ reach approximately $7.6 million, up approximately 300% from $1.9 million at year-end 2025

Agreement with a U.S. based, Nasdaq-listed biopharmaceutical company supports development activity in 2026 and clinical manufacturing planned for 2027

Potential additional clinical manufacturing carries an indicative, uncommitted service-fee value of $5.85 million for late 2027 through the first half of 2028, excluding additional scale-up, qualification and initial manufacturing activities not yet priced

JERUSALEM, Oct. 13, 2026 /PRNewswire/ -- Scinai Immunotherapeutics Ltd. (Nasdaq: SCNI) ("Scinai" or the "Company"), a biopharmaceutical company operating a growing contract development and manufacturing organization ("CDMO") alongside an immunology-focused therapeutic development platform, today announced that its wholly owned subsidiary, Scinai Biopharma Services Ltd., has entered into a definitive development and clinical manufacturing agreement with a U.S.-based, Nasdaq-listed biopharmaceutical company.

The agreement expands a previously disclosed customer engagement and includes approximately $5.1 million in committed base service fees, subject to performance and the agreement's terms, including applicable termination rights. The services are expected to contribute to revenue during 2026 and 2027 as the relevant performance obligations are satisfied, with stability services continuing beyond 2027. Advance and milestone payments for the committed services are expected to support cash flow and working capital during project execution.

Following execution, Scinai's Committed Customer Orders¹ across its Jerusalem and Yavne operations reached approximately $7.6 million, an increase of approximately 300% from $1.9 million at year-end 2025 and more than double the approximately $3.1 million reported as of August 16, 2026. The total excludes future pass-through purchases and associated markups until ordered and committed, as well as the potential additional manufacturing activities described below.

Amir Reichman, Chief Executive Officer of Scinai, commented:

"This agreement materially expands our contracted CDMO business and supports our strategy of delivering high-quality, bespoke CDMO services to international customers. It provides greater visibility into our manufacturing workload for 2027 and combines development and IND-enabling activities underway in 2026 with a clinical manufacturing program planned to begin in January 2027."

"Our priority is to translate these commitments into revenue, increased facility utilization and stronger operating performance, while continuing to aggressively grow the business. The potential for additional clinical supply and, ultimately, commercial manufacturing illustrates how these customer relationships can develop over time."

Committed services and project funding

The engagement covers integrated chemistry, manufacturing and controls ("CMC") development and clinical manufacturing for an investigational oncology product. Services include process and analytical development, manufacturing readiness, IND-enabling activities, a clinical manufacturing program, stability testing and development of a prefilled-syringe presentation. 

Potential expansion during 2027 and 2028

Potential additional clinical manufacturing has a combined indicative, uncommitted service-fee value of $5.85 million, with activities contemplated for late 2027 through the first half of 2028.

These activities remain subject to agreement on final scope and pricing, written authorization, available manufacturing capacity, and the customer's development and regulatory progress. The indicative value excludes scale-up, manufacturing-suite transition and qualification, and the first clinical batch in the new configuration, for which pricing has not yet been established. It also excludes project-related costs. These potential activities are not included in the initial $5.1 million commitment or in Committed Customer Orders.

The relationship also creates an opportunity for future commercial manufacturing, subject to the customer's clinical and regulatory progress, manufacturing requirements and a separate commercial agreement. No commercial supply volumes or related revenues are currently committed. 

Additional project-related charges 

In addition to the $5.1 million service commitment, Scinai will bill approved project-related costs separately, including a procurement and handling charge where applicable. These charges are expected to generate additional revenue, although the amount recognized as revenue may differ from total customer billings under applicable accounting requirements. 

About Scinai Immunotherapeutics

Scinai Immunotherapeutics Ltd. (Nasdaq: SCNI) is a biopharmaceutical company operating a growing contract development and manufacturing organization alongside an immunology-focused therapeutic development platform.

Through its wholly owned subsidiary, Scinai Biopharma Services Ltd., the Company provides development and manufacturing services to biotechnology and pharmaceutical companies at its facilities in Jerusalem and Yavne, Israel. Scinai also advances its NanoAb platform through research collaboration and license arrangements with the Max Planck Society and University Medical Center Göttingen, both in Germany.

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

Company Contacts

Business Development | +972 8 930 2529 | bd@scinai.com
Investor Relations, Allele Capital Partners | Brian DeBeer | +1 (561) 388-8178 | Brian.DeBeer@scinai.com

¹ Committed Customer Orders

Committed Customer Orders represent the aggregate value of committed customer orders for CDMO services and ordered project-specific pass-through charges, including applicable procurement and handling markups. The measure includes orders carried forward from prior year and new orders received during the reporting year, including orders scheduled for fulfillment in the subsequent year. Amounts invoiced or recognized as revenue during the reporting year remain included. Future pass-through purchases and associated markups are excluded until ordered and committed; uncommitted service activities are also excluded.

Management uses this supplemental operating measure to monitor customer-authorized activity and the scale of its contracted CDMO business. It is not calculated under GAAP, does not represent recognized revenue or remaining unfulfilled backlog, and does not guarantee future revenue or cash receipts. It may not be comparable to similarly titled measures used by other companies. Revenue recognition and payment timing depend on service performance, contractual milestones and applicable accounting requirements. Projects may be delayed or modified, and contractual termination provisions may apply.

Forward-Looking Statements

This press release contains forward-looking statements under applicable U.S. securities laws, including the Private Securities Litigation Reform Act of 1995. These statements address the expected scope, timing and financial contribution of the customer engagement; anticipated revenue and cash receipts during 2026, 2027 and subsequent periods; Committed Customer Orders; development and manufacturing schedules; potential additional clinical and commercial manufacturing; facility utilization; and growth of Scinai's CDMO business.

Actual outcomes may differ materially from current expectations. Relevant risks include technical, analytical, manufacturing, quality or regulatory difficulties; delays in equipment, materials or third-party services which can lead to delays in payments; changes in customer requirements or development plans; contractual modification or termination; delayed payments; failure to meet milestones; failure to activate optional activities; and differences between anticipated billings, cash collections and recognized revenue. Additional risks include financing requirements, competition, geopolitical conditions and the other risks described in the Company's Annual Report on Form 20-F and subsequent filings with the U.S. Securities and Exchange Commission.

The approximately $5.1 million service commitment remains subject to performance and the agreement's terms, including applicable termination rights. Potential additional program values are indicative, uncommitted and subject to final quotation and written authorization. No assurance is given that these activities or commercial manufacturing will proceed.

Forward-looking statements reflect expectations as of the date of this release. Scinai undertakes no obligation to update them except as required by law.

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SOURCE Scinai Immunotherapeutics Ltd.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

How much is Scinai's new development and clinical manufacturing agreement worth?

The agreement includes approximately $5.1 million in committed base service fees, subject to performance and contractual terms, including applicable termination rights. It expands an existing engagement with a U.S.-based, Nasdaq-listed biopharmaceutical company for an investigational oncology product.

What does Scinai's Committed Customer Orders measure include?

Committed Customer Orders includes committed CDMO service orders and ordered project-specific pass-through charges, including applicable markups. Orders carried forward from prior years and amounts already invoiced or recognized as revenue during the reporting year remain included. This non-GAAP operating measure is neither recognized revenue nor remaining unfulfilled backlog, and does not guarantee future revenue or cash receipts.

What is excluded from Scinai's potential $5.85 million manufacturing expansion?

The indicative, uncommitted $5.85 million service-fee value excludes scale-up, manufacturing-suite transition and qualification, the first clinical batch in the new configuration, and project-related costs. Pricing for those excluded manufacturing activities has not yet been established. The potential expansion is excluded from both the initial $5.1 million commitment and Committed Customer Orders.

What services will Scinai provide under the oncology manufacturing agreement?

Scinai will provide development and clinical manufacturing services for an investigational oncology product. The work includes process and analytical development, manufacturing readiness, activities supporting an investigational new drug application, a clinical manufacturing program, stability testing and development of a prefilled-syringe presentation.