Internal MOnthly Newsletter

Together, we build. Together, we grow.

What we achieved, how we're performing, who made it happen, and what matters next.

Issue: September 2026

CEO NOTE

A Note from Leadership

Perspective on the month, progress against our objectives, and where we're focusing next.

The past month has been particularly active across both sides of Scinai as we continue building the Company around two complementary businesses: Scinai Biopharma Services and Scinai Immunotherapeutics.

On the CDMO side, one of our most important near-term priorities is the Relmada NDV-01 program. Corporate, Legal, Quality, Business Development, Project Management, Engineering and the Jerusalem site have all been working intensively to move the program forward. This includes finalization of the Service Agreement and Quality Agreement, improvement of our costing and pricing approach, operational and engineering readiness, and detailed planning of the manufacturing campaign. Our shared objective is to support Relmada's plan to submit the NDV-01 IND *before the end of 2026**, making execution against the critical path over the coming months particularly important.*

At the same time, the Corporate team continues working to improve the way the Company operates. This includes strengthening procurement and purchasing processes, improving signatory and authorization management, enhancing financial and budget controls, reviewing both major and smaller customer agreements, and working with Business Development and Project Management to ensure that our pricing and costing methodologies support projects that are both commercially competitive and financially attractive. The objective is to build a company that operates efficiently, makes decisions quickly and maintains appropriate governance, accountability and visibility.

On the capital-markets side, Scinai completed the previously announced ADS ratio change/reverse split in August as part of our efforts to address Nasdaq's minimum $1 bid-price requirement. Following the ratio change, the Company's ADSs maintained a closing bid price above $1 for at least ten consecutive trading days. We are continuing our dialogue with Nasdaq and expect this to support the Company's return to compliance with the minimum bid-price requirement.

There have also been several important developments within Scinai Immunotherapeutics. Following a strategic portfolio review, we decided not to continue development of PC111 and not to extend/exercise the PinCell option arrangement. This allows us to preserve capital and focus our R&D resources on the NanoAb platform and the programs where we believe Scinai can create the greatest value.

For our intradermal IL-17 program, we are currently awaiting the decision on our FENG grant application for financing of up to approximately *€12 million**, with the decision currently expected by* September 22. Separately, an Israel Innovation Authority grant application supporting development of our bispecific IL-17 program was not approved in its initial review, and we have submitted an appeal. In parallel, work continues with Max Planck and UMG on amendments to the IL-17 license agreement to align the contractual framework with the evolving development strategy for the program.

Finally, building the right corporate culture remains central to what we are trying to achieve. As Jerusalem, Yavne and Immunotherapeutics become increasingly connected, our goal is to create a company characterized by collaboration, accountability, openness, operational excellence and continuous improvement. Growth is important, but equally important is building an organization in which people understand how their work contributes to our broader objectives and actively help colleagues and other functions succeed.

— Amir Reichman, CEO

Scinai at a Glance

Our recurring KPI dashboard — a consistent, simple read on how the business is performing, month over month.

TBD

committed orders YTD vs. budget by site

TBD

invoiced revenue YTD vs. budget

TBD

budget adherence, by site

active client programs in client review this month

grant initiatives advanced (FENG & IIA)

production batches completed at Jerusalem

Factory Acceptance Test passed (new filling line)

employees
company-wide

Financial KPIs (orders, revenue, budget adherence) are pending Finance's YTD-by-site figures — targeting next edition. Once in place, this dashboard runs the same way every month.

SECTION 01

Commercial & Customer Momentum

New customers, orders, proposals, opportunities in the funnel, meetings and partnerships — company-wide.

| New opportunities are stacking up for the immediate and mid-term.

Helen represented Scinai at BIO San Diego — our third conference showcasing the Recipharm collaboration,
with more than 35 meetings spanning CDMO value proposition, US-presence expansion and pipeline discussions.

Updates

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.
A new customer has signed on for nanoparticle work, a growing 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.

Jerusalem's most significant active commercial conversation this month — the Relmada feasibility work — is covered under Operations & Capabilities, below, since it's tied directly to site capability development.

WHY IT MATTERS

Nanoparticles, liposomes and cytotoxic-capable programs diversify our customer base beyond today's anchor accounts — the goal is steadier order flow into 2027, not dependence on any single client.

MOMENTUM THIS MONTH

Pipeline

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

Capabilities

New technology platforms coming online:
liposomes and nanoparticles.

Customer Retention

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

Brand & Partnerships

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

September Updates

Closer review of the Jerusalem and Yavne project pipelines, with continued tracking of project revenues across both sites.
Preparation and review of customer quotations, alongside technical-commercial assessment of new opportunities.
Continued work with Business Development and management to improve costing discipline and consistency in how proposals and customer programs are evaluated.
A senior Relmada delegation visits Jerusalem on September 16 for a full-day working session — more under Operations & Capabilities, below.

SECTION 02

Operations & Capabilities

What's being executed and what capabilities are being built at each site.

JERUSALEM

| TRG-200 project completed for Trigone Pharma; New filling line passes FAT.

Production team during processing; final filled syringes shown.

Five batches were produced this month — one technical, three media-fill, and one engineering batch of roughly 200 syringes — completing the TRG-200 process for Trigone Pharma's Phase 2 overactive-bladder product. The planned clinical batch was discontinued at the customer's request as they moved forward with their next product, NDV-001; manufacturing activities for NDV-001 have since been initiated, with QA documentation for its GMP Phase 3 run now in preparation.

Separately, the site's new filling machine successfully completed its Factory Acceptance Test — clearing it for installation and commissioning. Feasibility work is also underway for the Relmada project, alongside early preparations for future cytotoxic manufacturing capability.

WHY IT MATTERS

Completing TRG-200 to Trigone's satisfaction keeps them as a repeat customer and is already supporting a potentially significant follow-on project; the FAT pass keeps our filling-capacity expansion on schedule for later this year.

RELMADA / NDV-01 & STERILE MANUFACTURING CAPABILITY

Scinai has moved into active manufacturing-readiness activities for Relmada's NDV-01 program at the Jerusalem site. The project involves a complex cytotoxic aseptic manufacturing process, and is currently progressing through facility and equipment qualification, GMP documentation, analytical readiness and process preparation ahead of the planned IND-supporting manufacturing campaign.

NDV-01 is an important example of Scinai's evolving CDMO value proposition — combining process science, engineering, analytical development, Quality and aseptic manufacturing to support products that require complex sterile processing. This capability is increasingly relevant to several other opportunities in our pipeline.

On the filling line itself: following the FAT reported in the previous newsletter, activities are progressing toward installation, commissioning and qualification of the new platform. The system will significantly increase Scinai's flexibility and capacity for future sterile clinical manufacturing programs.

Yavne

| SKNY-1 & MIRA-55 scale-up work moves to pilot stage.

Scale-up for SKNY-1 and MIRA-55 has been completed at pilot scale — reaction conditions optimized, chromatographic purification resolved, and target purity and specification compliance achieved. Both now await customer approval to move into a continued technical batch. In parallel, the team is progressing toward the MIRA technical batch, running equipment IQ/OQ activities, and making ongoing improvements to site appearance and maintenance.

WHY IT MATTERS

Successful scale-up moves SKNY-1 and MIRA-55 toward paying technical-batch status, expanding Yavne's chemistry revenue base beyond its first anchor customers.

Updates

The Yavne team continued progressing customer programs MIRA-55 and SKNY-1, alongside equipment qualification and commissioning, analytical and LC-MS readiness, cleaning-validation activities, and permit and license follow-up. DOT implementation for production and maintenance management continues to roll out at the site.

STERILE LYOPHILIZATION CAPABILITY

We are also progressing plans to establish an expanded GMP lyophilization capability at the Yavne site as part of our infrastructure-development strategy. This would add another important technology platform to Scinai's sterile CDMO offering and support both current and future customer programs.

QUALITY, ACROSS BOTH SITES

Quality has centered much of its effort this period on NDV-01 — preparing and negotiating the Quality Agreement, defining testing requirements with QA/RA support, and overseeing manufacturing-readiness and qualification activities.

In parallel, the team continued supplier qualification, training, documentation and QMS harmonization across Jerusalem and Yavne. As the NDV-01 campaign approaches, holding execution speed and full GMP/regulatory compliance together remains the priority.

LOOKING AHEAD

Our near-term focus is completing the readiness activities required for the NDV-01 manufacturing campaign, while continuing to build scalable capabilities in complex sterile manufacturing, filling and lyophilization.

SECTION 03

R&D and Corporate/Strategic Milestones

Governance, legal, financial and strategic initiatives across both business units

| FENG grant documentation package submitted, following a major cross-functional effort.

Bispecific IL-17 program — FENG application — continued advancement of the FENG grant application supporting development of Scinai's bispecific IL-17 program through preclinical development and IND readiness.
MoEI Target Market grant, intradermal anti-IL-17 program — submitted an application under the Israeli Ministry of Economy and Industry's Target Market program to support U.S. market adaptation and commercialization of Scinai's intradermal anti-IL-17A/F program. The program is designed to de-risk the path to the U.S. market through product-specific positioning, market and payer validation, and targeted engagement with potential strategic partners — with the goal of advancing partnering opportunities that can support the program's continued development and commercialization.
TSLP NanoAb program — IP advancement with MPI — advanced the TSLP NanoAb program in collaboration with the Max Planck Institute, including submission of a PCT patent application covering the program.
Pincell — the license agreement with Pincell, previously in active amendment discussions, has since been discontinued.
We're expecting award decisions in September on the €12M grant for intradermal IL-17.

WHY IT MATTERS

Grant funding and progress on our licensing agreements support continued investment in the IL-17 program without relying solely on additional financing — and stronger governance processes scale with us as both business units grow.

SECTION 04

One Scinai

A specific project, achievement or initiative each month that shows Jerusalem, Yavne and Immunotherapeutics creating value together — not integration in the abstract, but people, expertise and capabilities actually working as one organization.

| Building one quality system across two sites.

Quality's team, spanning both sites, is unifying Jerusalem and Yavne under a single comprehensive quality system rather than running two separate ones. This month that work produced a concrete result — a successfully completed internal QA audit — while DOT implementation began rolling out at Yavne to bring both sites onto shared digital processes. Engineering has been working alongside them, aligning equipment and technical standards so the two sites build to one common specification rather than two.

ONE FILLING SYSTEM, ENGINEERED BY BOTH SITES

The engineering work behind the Ambica filling system's upgrade for NDV-01 didn't happen in a silo. Engineering has been supporting equipment qualification, facility modifications and infrastructure readiness across both Jerusalem and Yavne — the same team applying its expertise wherever it's needed rather than staying fixed to one site. It's a good example of how Scinai's capabilities are increasingly shared across the organization rather than remaining site-specific, and part of a broader move toward standardized technical practices company-wide.

BUILDING INTEGRATED OPERATIONS, PLANNING AND BUSINESS CONTROLS

As part of the continued integration of Jerusalem and Yavne operations, we're working to establish standardized operational and business processes across both sites — aligning procurement, supply chain, warehouse and inventory management, ERP processes and logistics, together with stronger planning, budgeting, financial control and management reporting.

A key focus is connecting operational and project planning with budgets, purchase commitments, actual expenditures and financial forecasts. This gives management better visibility, earlier identification of budget deviations and risks, and supports timely, informed decision-making — all while maintaining the GMP, Quality and regulatory standards the business runs on.

WHY IT MATTERS

A single quality system and common technical standards are what let Scinai sell customers one CDMO, not two separate operations — and they're what let people and expertise move fluidly between Jerusalem and Yavne as capacity needs shift.

Consistent, transparent ways of working across Scinai strengthen planning, operational efficiency and financial discipline — leveraging the capabilities and experience of both sites as One Scinai, rather than running two parallel back offices.

Employee Spotlight

The stage goes to one colleague; so people across Jerusalem, Yavne and the different functions get to know one another better.

[Employee name] — [role, site]

Where they're from: [answer]

What they studied: [answer]

Family & hobbies: [answer]

Day-to-day at Scinai: [answer]

Something colleagues might not know: [answer]

What they'd like the team to understand or pay attention to, to help them and their function succeed: [answer]

SECTION 05

People, Recognition & Safety

Our team, who earned recognition this month, and how we're staying safe.

Shavuot at the Jerusalem site — the first joint gathering of the company's two sites since the Yavne acquisition..

People

Company Overview

42 employees — 21 men and 21 women
23 employees hold advanced degrees, half of them PhDs.

Team Changes

Tehila continues to lead Jerusalem operations; Eilon has been appointed Yavne Site Head; Eran has joined as Head of Supply Chain. Sylvia has begun her transition toward retirement — thank you for everything you've built here. We also say goodbye to Alona and Maayan, and wish them well.

Processes — new contracts signed at the Yavne site; first equity grant issued to the new team, alongside rollout of the employee equity portal; cover insurance onboarding underway with our new insurance agency; vacation and absence policy updated; mobile usage policy aligned company-wide.

This has been a particularly active period for recruitment and onboarding, with multiple new employees joining Scinai across our sites and functions as we strengthen the resources behind our growing project portfolio. Full names and roles to follow once confirmed by Gal, so we can properly welcome them here.

The recent Town Hall and company gathering in Yavne brought colleagues from Jerusalem, Yavne and the Immunotherapeutics team together — recognizing employees for outstanding contributions and reinforcing our shared objectives as One Scinai.

HR — continued supporting onboarding of new employees, recruitment for additional positions, employee benefits and equity administration, management support, company activities, and preparations for important customer visits, including the upcoming Relmada visit.

Safety

EHS is now a permanent home in this section. Look for safety initiatives, training milestones and compliance updates here starting next edition — EHS lead, your first update goes here.

Recognition

Helen - for representing Scinai at BIO San Diego and running 35+ partner meetings across our third conference alongside the Recipharm team.

The Quality team — for completing this month's internal QA audit successfully.

The Jerusalem production team — for delivering all five TRG-200 batches to Trigone's satisfaction, including a smooth pivot when the clinical batch plan changed.

September Town Hall recognition — several employees were recognized for outstanding contributions at the recent Town Hall — full list of honorees to follow from Gal.

PERSONAL MILESTONES

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

Mazel 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.

SECTION 06

What Matters Next

The priorities leadership is watching heading into next month.

1. Advance NDV-001 manufacturing at Jerusalem, following TRG-200's completion.

2. Secure customer approval to move Skini & Mira into a continued technical batch at Yavne.

3. Complete installation and commissioning of the new filling line following its FAT.

4. Close out NDV-001's GMP Phase 3 preparation with Quality.

5. Keep the Yavne integration on track — rebranding, and summer coverage planning across both sites..

6. Ship, install and commission the modified Ambica filling system at Jerusalem for NDV-01.

7. Deliver a strong September 16 Remalda leadership visit, aligning on the NDV=01 critical path and year-end IND timeline.

7. Progress MIRA-55 and SKNY-1 at Yavne through equipment qualification, analytical readiness and cleaning validation, and finalize the NDV-01 Quality Agreement.

IMPACT

We're hiring across several roles. If you know someone great, reach out to Gal for current openings you can help share.

A senior Relmada delegation visits Jerusalem on September 16 — if you're on site, help make a strong impression. And a warm welcome to all our new colleagues joining Scinai this period!