Scinai

A question we get from new investors: why does an immunology-focused biotech also run a contract development and manufacturing business?

Here's the logic. Our CDMO, Scinai Biopharma Services, generates real revenue today from a growing base of biopharma customers - value reflected in current fundamentals like revenue and EBITDA. That cash also funds our required match on the non-dilutive grants behind our R&D pipeline, and the CDMO's operating experience and capabilities help accelerate our own pipeline programs.

The grants do more than reduce cash burn. Winning one means an independent panel reviewed the science, weighed it against competing programs, and chose to fund it - real third-party validation before we ever go back to investors. Paired with the match the CDMO funds, every grant dollar acts as a force multiplier on investors' capital.

That's the dual-engine model: a CDMO valued on fundamentals, funding and de-risking a pipeline whose value is about tomorrow's optionality - and once that pipeline is de-risked, it becomes a meaningful upside driver for the whole enterprise.

One NanoAbs platform. Multiple therapeutic designs.

Drug development is not only about selecting the right biological target. It is also about selecting the molecular format, route of administration and exposure profile that best match the disease biology and the intended therapeutic effect.

This is where the modularity of VHH antibody fragments becomes particularly valuable.

Scinai's NanoAbs can potentially be engineered into different therapeutic formats:

- Small monomeric constructs for local administration, where limited systemic exposure may be desirable
- Fc-containing formats designed for systemic administration and extended exposure
- Bi-specific and multi-specific antibodies capable of addressing more than one disease-relevant pathway

This flexibility is central to our development strategy.

Our current priority is a systemic bi-specific program combining our IL-17A/F VHH with a second, currently undisclosed target. Separately, our earlier-stage VHHs against targets involved in Type 2 inflammation, including IL-13 and TSLP, provide potential building blocks for future mono- and multi-specific therapeutic programs.

These NanoAbs were generated through our research collaboration with Max Planck Institute for Multidisciplinary Sciences and Universitätsmedizin Göttingen - UMG.

The value of a therapeutic platform is not simply the number of molecules it can generate. It is the ability to use the same underlying technology to design different medicines, with the format, route and PK/PD profile tailored to the intended mechanism of action.

That is the broader potential we are working to unlock from Scinai's NanoAbs platform.

The science behind our NanoAbs platform is built in partnership with two of the researchers who've spent their careers on the biology we're now advancing toward the clinic.

Prof. Dirk Görlich (Max Planck Institute for Multidisciplinary Sciences) and Prof. Matthias Dobbelstein (University Medical Center Göttingen) are the collaborators behind the nanobody science underpinning our systemic IL-17 bispecific program. Grateful for the partnership and the world-class science it's built on.

Today we're sharing an update on our pipeline: Scinai will not be pursuing a new extension of our option and license arrangement with PinCell for PC111.

This wasn't driven by a new, negative scientific finding. Rather, it reflects disciplined portfolio and capital allocation. We're concentrating resources where we see the clearest combination of differentiation, development feasibility, and capital efficiency: scaling our CDMO business, Scinai Biopharma Services (Committed Customer Orders ~$3.1M as of Aug 16, on track toward our ~$5M 2026 revenue objective), and advancing our systemic IL-17 bispecific NanoAb to the next major milestone.

Amir Reichman, CEO, has more in the video below. We wish the PinCell team continued success advancing PC111.

Link to the PR: https://loom.ly/sXRn6eo

Recent FDA budget proposals signal continued momentum behind rare disease innovation.

Among the proposed initiatives is legislation that would make the Rare Pediatric Disease Priority Review Voucher (PRV) program permanent, providing greater long-term regulatory predictability and reinforcing the FDA’s commitment to encouraging innovation for patients with rare diseases.

While these proposals remain subject to congressional approval, they reflect a continued focus on supporting the development of therapies for conditions with significant unmet medical need.

At Scinai, we view this as an encouraging signal. Our development-stage anti-sFasL monoclonal antibody, PC111, is being advanced for severe orphan dermatological diseases, including pemphigus vulgaris and Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), devastating conditions for which meaningful therapeutic innovation remains urgently needed.

We are proud to advance PC111 in collaboration with the exceptional team at Pincell. I would like to recognize CEO Amato, CSO Prof. Pincelli, Dr. Lotti, and Bennett for their scientific leadership, strategic vision, and dedication to advancing this promising therapeutic candidate. We look forward to continuing this collaboration as we work toward bringing new treatment options to patients with these devastating diseases.

Continued support for rare disease research and development helps foster an environment where innovative science can be translated into new treatment options for patients with limited therapeutic alternatives. We are excited to continue advancing our immunology pipeline and contributing to this important mission.

AbbVie's recent $10.9B acquisition of Apogee Therapeutics is another strong signal that immunology remains one of biotech's most attractive strategic markets.

The transaction reinforces continued demand for differentiated biologics targeting immune-mediated diseases and highlights the value that large pharmaceutical companies continue to place on innovative immunology platforms.

For Scinai Immunotherapeutics (NASDAQ: SCNI), this is an encouraging backdrop as we continue to advance our proprietary VHH (NanoAb) platform.

What differentiates our approach is that we are not building a single therapeutic product. We are building a modular platform that enables multiple therapeutic architectures from the same underlying VHH technology, allowing us to tailor each product candidate to its intended clinical target product profile.

Our NanoAb platform is designed to support:

• Modular engineering of multi-specific antibodies, enabling the development of next-generation therapeutics targeting multiple disease pathways within a single molecule.
• Excellent physicochemical stability, supporting robust manufacturing while offering the potential for improved formulation, storage and distribution.
• Flexible molecular engineering, allowing us to optimize tissue exposure, pharmacokinetics and dosing strategies by selecting the molecular architecture best suited for the intended mechanism of action and route of administration, from locally delivered VHHs to long-acting systemic antibody formats.

This flexibility allows us to engineer therapies around the biology of each disease rather than relying on a one-size-fits-all antibody design.

Strategic transactions such as AbbVie's acquisition of Apogee continue to reinforce the long-term opportunity in immunology. We believe Scinai's differentiated NanoAb platform positions us well to create innovative therapeutics and to become an attractive partner for companies seeking next-generation immunology solutions.

Among Scinai's pipeline assets, PC111 stands out as the company's flagship value driver.

PC111 is a first-in-class, fully-human, monoclonal antibody targeting soluble Fas Ligand (sFasL). PC111 is designed to treat severe, high-unmet-need dermatologic conditions, including Pemphigus and Stevens–Johnson syndrome / toxic epidermal necrolysis (SJS/TEN).

PC111 combines a differentiated mechanism with the advantages of an orphan indication, including the potential for regulatory incentives and an efficient development pathway.

In today's biotech environment, assets that combine clear unmet need, focused development pathways, and business development optionality are increasingly valuable. PC111 is positioned at that intersection.