Scinai Immunotherapeutics Shares Strong Nine-Month 2025 Performance as CDMO Services Thrive

Scinai Immunotherapeutics: Nine-Month 2025 Financial Review

Scinai Immunotherapeutics Ltd. (Nasdaq: SCNI) is gaining traction in the biopharmaceutical sphere, particularly in the realm of inflammation and immunology therapies. Recently, the company released its financial results for the first nine months of 2025, which document a period of significant growth and development in both its CDMO and research divisions.

Financial Highlights

For the first nine months of 2025, Scinai recorded revenues totaling $1,049 thousand, a remarkable increase from $452 thousand reported during the same period in 2024. This surge can be attributed largely to the expansion of Scinai’s CDMO business, particularly through contributions from its U.S. subsidiary.

Research and development (R&D) expenditures for the same period were reported at $1,799 thousand, significantly reduced from $4,195 thousand a year prior. This decline reflects a strategic shift in the allocation of resources, leading to a more efficient operation aimed at reducing overhead costs associated with R&D activities.

Administrative expenses, encapsulating marketing and general costs, rose to $1,929 thousand compared to $1,767 thousand in 2024. This uptick is reportedly linked to changes in previous insurance reimbursements recorded in the prior year, highlighting the ongoing adjustments within the company’s financial framework.

Financial expenses showed a contrasting decline from a net income of $13,374 thousand in the preceding year to a net loss of $607 thousand in 2025. This shift was significantly influenced by financial results stemming from loan conversions that occurred in 2024, which had positively impacted that year’s balance sheet.

In terms of cash flow, Scinai’s cash reserves stood at $3,005 thousand as of September 30, 2025, indicating a healthy increase from $1,964 thousand the previous year. These numbers reflect the company’s efforts to stabilize and enhance its financial health, despite the reported losses.

Business Development and Strategy

Amidst these financial developments, Scinai continues to elevate its standing in the boutique contract development and manufacturing organization (CDMO) sector. The company's CDMO arm, Scinai Bioservices, is focusing on servicing early-stage biotech firms not just in Israel, but also across the United States and Europe. Revenues from the U.S. division alone amounted to $502 thousand during this nine-month cycle, marking an encouraging footprint in the North American market.

Scinai also recently secured a non-dilutive grant of approximately NIS 809,000 (around $246,000) from the Israel Innovation Authority. This funding will aid in financing a significant investment in an advanced sterile fill-and-finish system aimed at enhancing their manufacturing capacity for small batches—a critical need for many initial-stage biotech firms.

Anticipated installation of this system is set for Q1 2026, with commercial operations slated to commence in Q2 2026. The Israel Innovation Authority has recognized the urgent need for local GMP compliant manufacturing infrastructure for Israel's biopharma sector, positioning Scinai as a pivotal player in addressing these gaps.

Advancements in Research and Development

Shifting focus back to Scinai's R&D endeavors, the firm is making strides in its NanoAbs pipeline, particularly targeting high-value IL-17 programs. Two STEP grant applications, each potentially granting up to €15 million, are currently in process, with funding decisions expected in early 2026. This financial backing would bolster Scinai's efforts in advancing its various therapeutic programs.

The company's flagship project, SCN-1, an intradermal IL-17A/F NanoAb for mild-to-moderate psoriasis, is approaching the pivotal Phase 1/2a trials. This unique therapy is crafted to offer localized biologic treatment with minimal systemic exposure, differentiating itself as a bridge between topical treatments and traditional systemic biologics.

In addition to SCN-1, Scinai is working on a bispecific IL-17A/F + second target (VHH-Fc) long-acting systemic biologic, intended for multiple indications including psoriasis and psoriatic arthritis. Expectations for substantial advancements are set high as the company awaits grant application outcomes that could secure essential funding for these initiatives.

Challenges and Future Outlook

However, not all news is positive; Scinai's application for a €12 million FENG grant supporting the development of PC111 was recently denied by Polish authorities. In light of this setback, Scinai is re-evaluating its strategies regarding the project, which involves exploring new non-dilutive grant opportunities or reconsidering its acquisition plans for Pincell, their development partner.

In general, Scinai is exploring collaborative partnerships for co-development and licensing across its wide-ranging product pipeline. CEO Amir Reichman expressed optimism regarding the company’s direction, emphasizing the strength of their operational capabilities and a disciplined approach to resource allocation.

Conclusion

With an ongoing commitment to innovation and expansion, Scinai Immunotherapeutics is poised to navigate both the challenges and opportunities presented in the biopharmaceutical landscape. The coming months are critical for the company as it seeks to solidify its position as a key player in the biotech sector while driving sustainable growth and creating long-term value for its stakeholders.