
NASDAQ: SCNI
A round-up of what moved forward this month across Scinai's Jerusalem and Yavne sites — manufacturing, quality, business development and the people behind it.

5
production batches completed at the Jerusalem site this month
42
employees company wide — 21 women, 21 men
23
team members hold advanced degrees, half of them PhDs
35+
partner meetings held at BIO San Diego

Updates
Five batches were produced this month: one technical batch, three media-fill batches, and one engineering batch of approximately 200 syringes — all part of the TRG-200 manufacturing process for Trigone Pharma's lead clinical-stage product for overactive bladder, currently in a Phase 2 study and administered via monthly bladder instillation.
The clinical batch was discontinued at the customer's request as they moved forward with another product, NDV-1.
What's Next?
Manufacturing activities for the company's next product, NDV-1, have been initiated.

Updates
The scale-up processes for Skini and Mira have been completed at pilot scale, including optimization of reaction conditions — stoichiometry, temperature profiles and impurity control. Chromatographic purification has also been completed, covering stationary phase selection, gradient tuning and load optimization, to resolve key impurities and hit target purity and specification compliance.
What's Next?
Skini and Mira now await customer approval to move into a continued technical batch.



Updates
Trigone Pharma — three media-fill batches and an engineering batch for the TRG-200 process were reviewed successfully; all documentation for the clinical batch has been completed.
Serpin Pharma — the Phase 2 clinical study in Germany has begun; labeling and packaging activities for the Sheba clinical trial are in progress; two additional trials are scheduled to start, in Israel and the United States.
NDV-001 — the QA program plan and supporting documents for GMP Phase 3 manufacturing are under preparation.
Skini & Mira — scale-up processes have been completed.
What's Next?
Preparation continues for NDV-001's GMP Phase 3 manufacturing.
Headline Metrics
4 active client programs moving through quality review in parallel this month.

Updates - Yavne
Discussions have renewed with a US-based company after some time away, and the prospect looks positive — the project would involve cytotoxic capabilities, a major opening for a new customer profile.
The Yavne site has started work with a new customer in nanoparticles, a growing industry segment Scinai is building capability to serve.
Our liposome capability is generating early demand, with several inquiries in — another new segment for Scinai.
Scinai has begun working with Allele, a US-based marketing agency, to focus on the US market.

Pipeline
Relmada discussions have renewed — a Phase III, large-scale opportunity.

Customer Retention
Existing clients, including Telomir Pharmaceuticals, are moving work from pre-clinical into clinical stage.

Marketing
A new US-based marketing agency partnership is now in place to support US market growth.

Capabilities
New technology platforms coming online: liposomes and nanoparticles.

New Pre-clinical Work
Fresh pre-clinical engagements are entering the pipeline behind our expanded platform capabilities.

Brand & Partnerships
New CDMO branding is live, alongside the final stretch of our work with the Recipharm team.

Company Overview
42 employees — 21 men and 21 women, full gender balance.
23 employees hold advanced degrees, half of them PhDs.
What's Next?
Continuing the integration journey: rebranding in progress, onboarding a Supply Chain Manager in early July, and planning ahead for the summer vacation period and coverage.
Updates
Organizational structure & team — 2026 objectives and job descriptions defined for the new structure; Tehila and Eilon appointed as site managers to lead operations at Jerusalem and Yavne respectively
Processes — new contracts signed at the Yavne site; first equity grant issued to the new team; work started with a new insurance agency; vacation and absence policy updated; corporate mobile usage policy aligned.

Congratulations to Ruth on the birth of her second daughter, Ariela.

Mazal tov to Yoel on the birth of his first son, Reshef — Silvia and Enrique's third grandchild.

Congratulations to Solomon on his son's wedding.
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