Scinai Reports Nine-Month 2025 Results as CDMO Growth Continues and NanoAbs Pipeline Advances

Rhea-AI Summary

Scinai (NASDAQ: SCNI) reported nine-month 2025 results and corporate updates. Revenues were $1,049k vs $452k a year earlier, driven by CDMO expansion including $502k from its U.S. subsidiary. R&D expenses fell to $1,799k from $4,195k; MG&A were $1,929k. Financial expenses, net were $607k versus financial income of $13,374k in 2024. Net loss was $6,244k versus net profit $7,026k year-ago. Cash and short-term deposits totaled $3,005k.

Operational highlights: a NIS 809k (~$246k) non-dilutive IIA grant for sterile fill-finish (installation Q1 2026, commercial Q2 2026); two separate €15m STEP grant decisions expected Q1 2026 for NanoAb programs; PC111 €12m FENG grant was not approved and Scinai is re-evaluating options, with a Pincell SPA option conditional on demonstrating $3m earmarked by Feb 28, 2026.

Positive

• Revenue +132% YoY to $1,049k
• U.S. subsidiary contributed $502k in nine months 2025
• R&D spend down 57% YoY to $1,799k
• IIA non-dilutive grant ~NIS 809k (~$246k) for fill-finish capacity

Negative

• Net loss $6,244k for nine months vs $7,026k net profit prior year
• Financial expenses net $607k vs financial income $13,374k in 2024
• €12m FENG grant for PC111 not approved, program path under review
• Pincell SPA option requires $3m earmarked by Feb 28, 2026 to exercise

News Market Reaction

+3.00%

7 alerts

+3.00% News Effect

+9.5% Peak in 30 hr 22 min

+$116K Valuation Impact

$4M Market Cap

1.4x Rel. Volume

On the day this news was published, SCNI gained 3.00%, reflecting a moderate positive market reaction. Argus tracked a peak move of +9.5% during that session. Our momentum scanner triggered 7 alerts that day, indicating moderate trading interest and price volatility. This price movement added approximately $116K to the company's valuation, bringing the market cap to $4M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Nine-month 2025 revenue: $1,049k Nine-month 2024 revenue: $452k R&D expenses 2025: $1,799k +5 more

8 metrics

Nine-month 2025 revenue $1,049k Nine months ended Sep 30, 2025

Nine-month 2024 revenue $452k Nine months ended Sep 30, 2024

R&D expenses 2025 $1,799k Nine months ended Sep 30, 2025

R&D expenses 2024 $4,195k Nine months ended Sep 30, 2024

Net loss 2025 $6,244k Nine months ended Sep 30, 2025

Net profit 2024 $7,026k Nine months ended Sep 30, 2024

Cash and equivalents $3,005k As of Sep 30, 2025

IIA grant amount NIS 809,000 (~$246,000) Non-dilutive grant for fill-and-finish system

Market Reality Check

Price: $1.03 Vol: Volume 6,683 shares vs 20...

low vol

$1.03 Last Close

Volume Volume 6,683 shares vs 20-day average of 45,365 shares indicates subdued trading activity ahead of this update. low

Technical Shares at $1.23, trading below the 200-day MA of $2.04, reflecting a longer-term downtrend into the report.

Peers on Argus

Biotech peers showed mixed moves, with examples like GTBP -7.14% and PBM +5.44%,...

1 Up

Biotech peers showed mixed moves, with examples like GTBP -7.14% and PBM +5.44%, while SCNI traded near flat (-0.81%

Historical Context

5 past events · Latest: Dec 02 (Neutral)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 02	Nine-month results	Neutral	+3.0%	CDMO revenue growth, cash update, and mixed grant and profit/loss shift.
Oct 06	CDMO grant win	Positive	+1.9%	Non-dilutive IIA grant to fund new sterile fill-and-finish system.
Sep 02	H1 2025 earnings	Positive	+0.7%	CDMO revenue growth, narrowed net loss, and new capital raise.
Jul 29	PC111 publication	Positive	-2.4%	Peer-reviewed data supporting PC111 as disease-modifying therapy.
Jun 26	PC111 award news	Positive	-2.0%	Recognition of PC111 research with major dermatology award.

Pattern Detected

Recent news and earnings have typically produced modest price moves of a few percent, with a mix of aligned and divergent reactions to generally positive operational updates.

Recent Company History

Over the last six months, Scinai has reported expanding CDMO revenues, multiple grant-related milestones, and advancing I&I programs. H1 2025 results highlighted CDMO-driven revenue growth and balance sheet strengthening. Subsequent news emphasized PC111 scientific validation and recognition, alongside funding optionality. Today’s nine-month 2025 update reiterates CDMO momentum, cash of $3,005k, and mixed grant outcomes, fitting into a pattern of incremental operational progress paired with modest share-price reactions.

Market Pulse Summary

This announcement details nine-month 2025 results showing CDMO-driven revenue of $1,049k, lower R&D ...

Analysis

This announcement details nine-month 2025 results showing CDMO-driven revenue of $1,049k, lower R&D expenses, and cash of $3,005k, alongside a $6,244k net loss. Operationally, Scinai is expanding fill-and-finish capacity with a non-dilutive IIA grant and advancing multiple IL-17 NanoAb programs while reassessing PC111 after a €12 million grant refusal. Investors may track upcoming EU STEP grant decisions, execution of the Pincell SPA option, and CDMO order growth.

Key Terms

cdmo, nanoabs, il-17a/f, mesogun, +4 more

8 terms

cdmo technical

"operating a growing boutique CDMO business unit, today reported its"

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.

nanoabs medical

"R&D Business - NanoAbs and PC111 ProgramsNanoAbs Pipeline — Focused on"

Nanoabs are very small, engineered antibody fragments—often called nanobodies or nanoantibodies—designed to bind specific proteins in the body. Because they are much smaller than conventional antibodies, they can reach tight spaces, enter tissues more easily, and are often cheaper and faster to manufacture; for investors, that can mean medicines or diagnostics with potentially better effectiveness, simpler production, and different risk/reward profiles compared with traditional antibody drugs.

il-17a/f medical

"SCN-1 (Lead Program): Intradermal IL-17A/F NanoAb for Mild–Moderate Psoriasis"

IL-17A/F is a signaling protein produced by certain immune cells that combines elements of two related molecules (IL-17A and IL-17F) and helps trigger and amplify inflammation. It matters to investors because therapies that block or modulate IL-17A/F can reduce symptoms in autoimmune and inflammatory diseases, so clinical trial results, regulatory decisions, and safety signals for such drugs can significantly change a biotech or pharmaceutical company's market value—like repairing a faulty circuit that stabilizes a machine.

mesogun medical

"VHH delivered intradermally in a painless manner via mesogun, enabling"

A mesogun is a handheld medical-aesthetic device that delivers very small, controlled doses of liquids—like vitamins, acids or medications—into the skin or just below it, used in treatments such as mesotherapy, hair restoration and scar or wrinkle reduction. Investors care because sales, replacement cartridges and training drive recurring revenue, while safety records, regulatory approvals and how widely clinics adopt the device directly affect a company’s market value—think of it as a specialized “printer” that requires ongoing consumables and customer trust.

vhh-fc medical

"Bispecific IL-17A/F + Second Target (VHH-Fc): Long-Acting Systemic Biologic"

A VHH-Fc is a lab-made protein that combines a tiny, single-domain antibody fragment (VHH or “nanobody”) with the tail portion of a regular antibody (Fc). The VHH part acts like a focused key that sticks to a specific target, while the Fc tail extends how long the molecule stays in the body and can recruit the immune system; think of it as a compact tool with a built-in handle and longer battery life. For investors, VHH-Fc constructs signal a therapeutic approach that can offer easier manufacturing, potentially lower doses and longer-lasting effects compared with conventional antibodies, which affects development costs, dosing schedules and market potential.

gmp technical

"lack of local, flexible GMP manufacturing infrastructure is a major bottleneck"

Good Manufacturing Practice (GMP) is a set of regulatory standards and procedures that ensure products—especially medicines, medical devices, and related goods—are consistently made to meet safety, quality, and purity requirements. For investors, GMP compliance is like a factory’s hygiene and checklist system: it reduces the risk of product recalls, regulatory fines, and production stoppages, supports market access, and signals more reliable, lower-risk operations that can protect revenue and reputation.

step grant regulatory

"supported by two STEP grant applications of up to €15 million each"

A step grant is funding awarded in ordered stages, where each payment or tranche is released only after the recipient meets predefined milestones or conditions. For investors, it matters because staged payments reduce upfront risk and tie future funding to progress—similar to paying a contractor in installments as they complete parts of a project—so the recipient’s ability to hit milestones affects future cash needs, valuation, and the timing of potential returns.

spa financial

"exclusive option to exercise the Share Purchase Agreement (SPA) for 100%"

A sale and purchase agreement (SPA) is a legally binding contract that lays out the exact terms for buying or selling a company, business unit, or shares, including price, what is being transferred, and conditions that must be met before the deal closes. For investors it matters because the SPA determines who gets what, when money changes hands, what warranties or indemnities protect buyers and sellers, and therefore directly affects the value, timing and risk of a transaction — much like a detailed recipe and checklist for a home sale.

AI-generated analysis. Not financial advice.

12/02/2025 - 08:50 AM

JERUSALEM, Dec. 2, 2025 /PRNewswire/ -- Scinai Immunotherapeutics Ltd. (Nasdaq: SCNI) ("Scinai", or the "Company"), a biopharmaceutical company developing innovative inflammation and immunology (I&I) therapeutics and operating a growing boutique CDMO business unit, today reported its financial results and corporate highlights for the nine months ended September 30, 2025.

First Nine Months 2025 Financial Summary

• Revenues for the nine months ended September 30, 2025 were $1,049 thousand, compared to $452 thousand for the nine months ended September 30, 2024. The increase reflects continued expansion of Scinai Bioservices, including contributions from the Company's U.S. subsidiary.
• R&D expenses for the nine months ended September 30, 2025 amounted to $1,799 thousand, compared to $4,195 thousand for the nine months ended September 30, 2024. The decrease was primarily due to lower allocation of employees and facility costs to the R&D business unit.
• Marketing, general and administrative expenses for the nine months ended September 30, 2025 were $1,929 thousand, compared to $1,767 thousand for the nine months ended September 30, 2024. The increase was mainly due to insurance reimbursement recorded in 2024.
• Financial Expenses, net, for the nine months ended September 30, 2025, were $607 thousand compared to financial income of $13,374 thousand for the nine months ended September 30, 2024. The change was primarily driven by the financial income from loan conversion recorded in 2024.
• Net loss for the nine months ended September 30, 2025 was $6,244 thousand compared to net profit of $7,026 thousand for the nine months ended September 30, 2024. The variance reflects the financial income from loan conversion recognized in 2024.

 As of September 30, 2025, cash, cash equivalents and short-term deposits totaled $3,005 thousand, compared to $1,964 thousand as of September 30, 2024.

Business Update

CDMO Business - Scinai Bioservices

Scinai Bioservices continues to expand its role as a boutique CDMO serving early-stage biotech companies in Israel, the United States, and Europe.

• The Company's U.S. subsidiary contributed $502 thousand in revenues during the first nine months of 2025, demonstrating early traction in North America.
• Scinai recently received a non-dilutive grant of approximately NIS 809,000 net (approximately $246,000) from the Israel Innovation Authority to fund two-thirds of a NIS 1.23 million (approximately $373,000) investment in an advanced sterile fill-and-finish system.
• The new system is designed to provide rapid batch turnaround and flexible switching between campaigns, substantially improving small-batch manufacturing capacity for early-stage biotech clients.
• Installation and qualification are expected in Q1 2026, with commercial operation planned in Q2 2026.

The IIA noted in its award letter that the lack of local, flexible GMP manufacturing infrastructure is a major bottleneck for Israel's 300+ biopharma companies and recognized Scinai's growing role in addressing this national and global gap.

R&D Business - NanoAbs and PC111 Programs

NanoAbs Pipeline — Focused on High-Value IL-17 Programs and Strategic Partnering

Scinai is advancing a focused NanoAb pipeline in inflammation and immunology, supported by two STEP grant applications of up to €15 million each, with funding decisions expected in Q1 2026. The Company is actively seeking partners for co-development or licensing across all programs.

SCN-1 (Lead Program): Intradermal IL-17A/F NanoAb for Mild–Moderate Psoriasis

Approaching Phase 1/2a, a decision on the Company's application for a €15 million grant under the EU STEP program is expected Q1 2026

• First localized biologic designed specifically for mild–moderate psoriasis.
• Potent IL-17A/F neutralizing VHH delivered intradermally in a painless manner via mesogun, enabling targeted treatment with minimal systemic exposure.
• Establishes a new category between topicals and systemic biologics.
• Clear value for patients, physicians, payers, and commercial partners.
• Supported by translational data and progressing toward Phase 1/2a entry.

Bispecific IL-17A/F + Second Target (VHH-Fc): Long-Acting Systemic Biologic

For psoriasis, PsA, HS, and broader I&I, a decision on the Company's application for a €15 million grant under the EU STEP program is expected Q1 2026. This grant application is separate and in addition to the one related to SCN-1 mentioned above.

• Dual-target VHH-Fc architecture provides enhanced biologic activity and extended half-life.
• Applicable across multiple high-value I&I indications.
• Designed for systemic administration with differentiated mechanism and dosing profile.

Third Program: Four New NanoAbs from Max Planck / UMG Collaboration

Patent filings in 2025, Exclusive licensing option expected to be exercised by Q1 2026

• Four novel NanoAbs generated under Scinai's research collaboration with MPG and UMG.
• Patent applications filed in 2025.
• Scinai plans to exercise its exclusive licensing option by Q1 2026.
• Expands the pipeline into additional high-need I&I pathways.

PC111 - Strategic Assessment Following Grant Outcome

On November 24, 2025, Scinai received formal notice from the Polish grant authorities that its €12 million FENG grant application supporting development of PC111 was not approved. As a result, Scinai and its development partner, Pincell Srl, are currently reviewing the program's forward path and evaluating several alternatives. These include, among other options, submitting a new non-dilutive grant application in early 2026 or potentially terminating Scinai's option to acquire Pincell if a viable financing path cannot be secured.

Scinai currently holds an exclusive option to exercise the Share Purchase Agreement (SPA) for 100% of Pincell's fully diluted share capital through February 28, 2026, with no additional purchase price required at exercise. The exercise of this option is conditional upon Scinai demonstrating at least $3 million specifically earmarked for PC111's development. The Company will update the market once its joint assessment with Pincell is complete and a defined strategic path has been selected.

Partnering Outlook

Scinai is currently engaged in outreach for co-development, global or regional licensing, or broader platform partnerships across all pipeline programs.

CEO Statement

"2025 has been a year of significant progress across our CDMO and R&D business units," said Amir Reichman, CEO of Scinai. "Our CDMO operations continue to build momentum and strengthen their position as a trusted partner for emerging biotech companies. On the R&D side, while the recent grant outcome for PC111 was not what we had hoped for, the underlying science remains strong. Together with our partners at Pincell, we are now evaluating the best strategic path forward for the program, including potential non-dilutive funding routes or alternative options. At the same time, our NanoAbs pipeline continues to advance with promising differentiation and clear partnering opportunities. With growing operational capabilities and a disciplined approach to resource allocation, we remain committed to creating long-term value for patients and shareholders."

About Scinai Immunotherapeutics

Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) is a biopharmaceutical company with two complementary business units:

• Scinai Bioservices, a boutique CDMO providing analytical method development, process development, and clinical cGMP manufacturing services for biotech clients worldwide.
• Scinai R&D, focused on developing innovative I&I therapeutics based on NanoAbs (VHH antibody fragments) with unique physicochemical properties suitable for advanced mono- and multi-specific antibody formats

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. Examples of such statements include, but are not limited to, statements regarding grant applications under the EU STEP program and timing of commercial operations. 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 otherwise 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; failure to receive grants under the EU STEP program or a delay in receiving grant decisions; delay in commencement of commercial operation of advanced sterile fill-and-finish system; a delay in the commencement and results of pre-clinical and clinical studies, 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; the risk that the manufacturing facility will not be able to be used for a wide variety of applications and other vaccine and treatment technologies; 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.

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SOURCE Scinai Immunotherapeutics Ltd.

FAQ

What were Scinai's nine-month 2025 revenues and how did they compare to 2024 (SCNI)?

Nine-month 2025 revenues were $1,049k compared with $452k in the same period of 2024.

How much did Scinai's U.S. subsidiary contribute to SCNI revenues in 2025?

The U.S. subsidiary contributed $502k in revenues during the first nine months of 2025.

What was Scinai's cash position as of September 30, 2025 (SCNI)?

Cash, cash equivalents and short-term deposits totaled $3,005k as of September 30, 2025.

What grant funding did Scinai receive for manufacturing capacity and when will it be operational (SCNI)?

Scinai received a NIS 809k (~$246k) IIA grant for a sterile fill-and-finish system; installation is expected in Q1 2026 and commercial operation in Q2 2026.

What is the status of Scinai's NanoAbs STEP grant applications and timeline (SCNI)?

Scinai submitted two separate €15m STEP grant applications; funding decisions are expected in Q1 2026.

What happened to the PC111 €12m FENG grant and how does it affect Scinai's option on Pincell (SCNI)?

The €12m FENG grant was not approved; Scinai and Pincell are reassessing options and the SPA option requires $3m earmarked for PC111 by Feb 28, 2026 to exercise.