Scinai

Scinai Scinai Immunotherapeutics | Previously BiondVax | Nasdaq: $SCNI

10/11/2025

Industry Insight: Why “Good Data” Sometimes Isn’t Good Enough

Recent Phase 3 readouts in the inflammation and immunology (I&I) space have shown that even statistically positive results may not be enough. Investors and prescribers are increasingly demanding meaningful differentiation: new therapies must not only work but deliver real-world value for patients, physicians, and payers.

At Scinai Immunotherapeutics, we’re addressing this challenge with a first-in-class intradermal nanobody platform designed to deliver biologics locally, directly to the site of inflammation, rather than systemically throughout the body.

Our lead psoriasis program targets patients underserved by current options, including:

Mild-to-moderate patients who wish to avoid chronic topical corticosteroid use due to side effects such as skin atrophy.
Patients using advanced topicals (e.g., ZorivE™, Vtama®) who struggle with daily application and adherence.
Phototherapy patients who must attend frequent outpatient sessions for weeks at a time.
Patients with lesions in sensitive areas (face, scalp, ge****ls, palms, soles) who may currently receive systemic biologics due to the psychosocial burden of their disease, even though their overall disease severity is limited.

Our intradermal administration is performed using a mesogun, a device already well established in dermatology for applications such as hair restoration and skin rejuvenation. This approach enables precise, virtually painless delivery of nanobody-based biologics directly into the affected skin.

By providing a localized, safer, and more convenient alternative to systemic biologics, our technology addresses a key unmet need: offering biologic-level efficacy appropriate to the patient’s disease severity while reducing systemic exposure, improving adherence, and lowering overall treatment costs.

As the field seeks innovation that goes beyond incremental efficacy improvements, Scinai’s localized nanobody platform offers a de-risked, differentiated path to redefining care for inflammatory skin diseases.

👉 Learn more at www.scinai.com

20/10/2025

🤝 𝐏𝐚𝐫𝐭𝐧𝐞𝐫𝐢𝐧𝐠 𝐟𝐨𝐫 𝐈𝐧𝐧𝐨𝐯𝐚𝐭𝐢𝐨𝐧: 𝐀 𝐠𝐥𝐢𝐦𝐩𝐬𝐞 𝐢𝐧𝐭𝐨 𝐨𝐮𝐫 𝐣𝐨𝐮𝐫𝐧𝐞𝐲 𝐰𝐢𝐭𝐡 𝐇𝐨𝐩𝐞𝐜 𝐏𝐡𝐚𝐫𝐦𝐚
When Hopec Pharma set out to develop DOR-100, a novel therapy for Non-Muscle Invasive Bladder Cancer (NMIBC), they needed a CDMO partner to turn their concept into a scalable, GMP-ready process.
“𝑊𝑒 𝑤𝑒𝑟𝑒 𝑖𝑛𝑠𝑝𝑖𝑟𝑒𝑑 𝑏𝑦 𝐻𝑜𝑝𝑒𝑐’𝑠 𝑡𝑒𝑐ℎ𝑛𝑜𝑙𝑜𝑔𝑦 𝑎𝑛𝑑 𝑘𝑛𝑒𝑤 𝑤𝑒 ℎ𝑎𝑑 𝑡𝑜 𝑑𝑒𝑠𝑖𝑔𝑛 𝑎 𝑡𝑎𝑖𝑙𝑜𝑟𝑒𝑑 𝑝𝑟𝑜𝑐𝑒𝑠𝑠 - 𝑤𝑖𝑡ℎ 𝑡ℎ𝑒 𝑟𝑖𝑔ℎ𝑡 𝑐𝑜𝑛𝑡𝑟𝑜𝑙𝑠 𝑎𝑛𝑑 𝑡𝑒𝑠𝑡𝑖𝑛𝑔 - 𝑡𝑜 𝑚𝑒𝑒𝑡 𝑠𝑡𝑟𝑖𝑐𝑡 𝐺𝑀𝑃 𝑎𝑛𝑑 𝑟𝑒𝑔𝑢𝑙𝑎𝑡𝑜𝑟𝑦 𝑠𝑡𝑎𝑛𝑑𝑎𝑟𝑑s,” says Tehila Sonnenfeld Scinai Director of Production.
Scinai Immunotherapeutics Ltd. team partnered closely with Hopec from development through GMP manufacturing, ensuring a seamless, efficient path to first-in-human production.
💬 Estee Rosen, Co-Founder and Chairwoman at Hopec Pharma, shares: “𝑆𝑐𝑖𝑛𝑎𝑖 𝑡𝑜𝑜𝑘 𝑎 ℎ𝑜𝑙𝑖𝑠𝑡𝑖𝑐 𝑎𝑝𝑝𝑟𝑜𝑎𝑐ℎ 𝑡ℎ𝑎𝑡 𝑤𝑒𝑛𝑡 𝑓𝑎𝑟 𝑏𝑒𝑦𝑜𝑛𝑑 𝑚𝑎𝑛𝑢𝑓𝑎𝑐𝑡𝑢𝑟𝑖𝑛𝑔 — 𝑓𝑟𝑜𝑚 𝑢𝑛𝑑𝑒𝑟𝑠𝑡𝑎𝑛𝑑𝑖𝑛𝑔 𝑜𝑢𝑟 𝑠𝑐𝑖𝑒𝑛𝑐𝑒 𝑡𝑜 𝑐𝑟𝑒𝑎𝑡𝑖𝑛𝑔 𝑎𝑛 𝑒𝑓𝑓𝑖𝑐𝑖𝑒𝑛𝑡, 𝑠𝑐𝑎𝑙𝑎𝑏𝑙𝑒, 𝑎𝑛𝑑 𝑐𝑜𝑚𝑚𝑒𝑟𝑐𝑖𝑎𝑙𝑙𝑦 𝑎𝑣𝑎𝑖𝑙𝑎𝑏𝑙𝑒 𝑝𝑟𝑜𝑐𝑒𝑠𝑠. 𝑇ℎ𝑒𝑖𝑟 𝑒𝑥𝑝𝑒𝑟𝑡𝑖𝑠𝑒 𝑎𝑛𝑑 𝑠𝑢𝑝𝑝𝑜𝑟𝑡 𝑎𝑙𝑙𝑜𝑤𝑒𝑑 𝑢𝑠 𝑡𝑜 𝑚𝑜𝑣𝑒 𝑓𝑜𝑟𝑤𝑎𝑟𝑑 𝑞𝑢𝑖𝑐𝑘𝑙𝑦 𝑎𝑛𝑑 𝑐𝑜𝑛𝑓𝑖𝑑𝑒𝑛𝑡𝑙𝑦.”
💬 Gadi Klarsfeld, Co-Founder and CEO of Hopec Pharma adds:
“𝑆𝑐𝑖𝑛𝑎𝑖 𝑑𝑒𝑙𝑖𝑣𝑒𝑟𝑠 𝑓𝑎𝑟 𝑏𝑒𝑦𝑜𝑛𝑑 𝑠𝑡𝑎𝑛𝑑𝑎𝑟𝑑 𝐶𝐷𝑀𝑂 𝑠𝑒𝑟𝑣𝑖𝑐𝑒 — ℎ𝑒𝑙𝑝𝑖𝑛𝑔 𝑖𝑛𝑛𝑜𝑣𝑎𝑡𝑜𝑟𝑠 𝑙𝑖𝑘𝑒 𝑢𝑠 𝑏𝑟𝑖𝑛𝑔 𝑛𝑒𝑤 𝑡ℎ𝑒𝑟𝑎𝑝𝑖𝑒𝑠 𝑐𝑙𝑜𝑠𝑒𝑟 𝑡𝑜 𝑝𝑎𝑡𝑖𝑒𝑛𝑡𝑠.”
🎥 Get a glimpse into our project in the video below, and follow the link to view the full video to learn more about Hopec Pharma’s innovative therapy and the journey with Scinai.
Thank you, Estee, Gadi, and the entire Hopec Pharma team, for choosing Scinai as your CDMO partner. We are inspired to collaborate with innovators like you to bring your life-changing therapy to patients.

16/10/2025

אנחנו ב Scinai גאים ונרגשים על הזכייה במסלול מעבדות מו"פ ומאגרי מידע של קרן תשתיות ברשות החדשנות
תודה גדולה לרשות החדשנות על האמון, הליווי והתמיכה המתמשכת – בעלי תרומה משמעותית לקידום הביוטק הישראלי ולחיזוק התעשייה המקומית. 🇮🇱✨

Send a message to learn more

Scinai is heading to BIO-Europe2025 — and we can’t wait to connect with the biopharma community!🔹 𝐏𝐡𝐚𝐫𝐦𝐚 𝐏𝐚𝐫𝐭𝐧𝐞𝐫𝐬 & 𝐈𝐧𝐯𝐞...
30/09/2025

Scinai is heading to BIO-Europe2025 — and we can’t wait to connect with the biopharma community!
🔹 𝐏𝐡𝐚𝐫𝐦𝐚 𝐏𝐚𝐫𝐭𝐧𝐞𝐫𝐬 & 𝐈𝐧𝐯𝐞𝐬𝐭𝐨𝐫𝐬 — Learn about our pipeline progress, including the exclusive license for PC111, a novel monoclonal antibody for Pemphigus Vulgaris and SJS/TEN, developed by PinCell srl. This first-in-class asset holds blockbuster potential in rare autoimmune skin diseases.
🔹 𝐁𝐢𝐨𝐭𝐞𝐜𝐡 𝐈𝐧𝐧𝐨𝐯𝐚𝐭𝐨𝐫𝐬 - Explore how our boutique CDMO BioServices unit can accelerate your biologics program with flexible, cost-efficient solutions from cell line development through cGMP manufacturing. Now enhanced by expanded access to U.S. federal funding via our U.S. subsidiary under the Bio Secure Act.
💡 With a revenue-generating CDMO and a growing therapeutic pipeline, Scinai is positioned for strategic growth and collaboration.
📩 Want to meet us at BIO-Europe?
Schedule a meeting with Scinai CEO Amir Reichman via the BIO-Europe partnering system or 📩 bd@scinai.com
Let’s shape the future of immunotherapy and biomanufacturing together!

🍎✨ 𝐒𝐡𝐚𝐧𝐚 𝐓𝐨𝐯𝐚 – 𝐇𝐚𝐩𝐩𝐲 𝐉𝐞𝐰𝐢𝐬𝐡 𝐍𝐞𝐰 𝐘𝐞𝐚𝐫 ✨🍯 As we welcome 5786, we wish all our customers, partners, colleagues, and follow...
18/09/2025

🍎✨ 𝐒𝐡𝐚𝐧𝐚 𝐓𝐨𝐯𝐚 – 𝐇𝐚𝐩𝐩𝐲 𝐉𝐞𝐰𝐢𝐬𝐡 𝐍𝐞𝐰 𝐘𝐞𝐚𝐫 ✨🍯
As we welcome 5786, we wish all our customers, partners, colleagues, and followers a year filled with peace, health, growth, prosperity, and meaningful progress. May our collaborations continue to flourish and reach new heights together.
This holiday, our hearts are with the 48 hostages still held captive by Hamas, and we pray for their immediate return, for healing, an end to the war, and the safe return of all our soldiers.
Wishing you a happy and successful New Year, from all of us at Scinai.

Wrapping up a fantastic (last) week for Scinai! Our CEO, Amir Reichman, had an incredible time connecting with investors...
16/09/2025

Wrapping up a fantastic (last) week for Scinai!

Our CEO, Amir Reichman, had an incredible time connecting with investors, partners, and fellow innovators at both the H.C. Wainwright Annual Global Investment Conference in New York City and the 16th Annual World Bispecific Summit in Boston.

From insightful discussions to meaningful new connections, these events were a great opportunity to share Scinai’s progress and explore collaborations that advance next-generation immunotherapies.

A big thank you to everyone who took the time to meet with us, your interest and engagement inspire us as we continue to grow.

09/09/2025

CYMI: Scinai Reported Positive Results for the First Half of the Year in their Q2 Report!

In this 90 second review, see how we’ve driven growth and efficiency in the first half of 2025. Some of those core highlights include:

✅ Raised more than $4M through our SEPA agreement
✅ Reduced operating expenses by 50% while advancing R&D activities
✅ Boosted CDMO revenues by 2.5x vs. the same period last year

We’re proud of the progress made in the first half of 2025 and excited for the road ahead.

Watch the full recap video below and sign up on our website for the latest updates!

Send a message to learn more

03/09/2025

📢 Save the Date!

Scinai will be attending two major industry events this September:

📍 H.C. Wainwright Annual Global Investment Conference
🗓️ September 8–10, 2025
📌 Lotte New York Palace Hotel, New York City

📍 16th Annual World Bispecific Summit
🗓️ September 9–11, 2025
📌 Boston, MA

We look forward to engaging with investors, partners, and industry leaders to share Scinai’s vision and progress in advancing next-generation immunotherapies.

Stay tuned for more updates, and we hope to see you there!

Scinai Immunotherapeutics Ltd. Reports 1H 2025 Results: Highlighting CDMO Revenue Growth and a Strengthened Balance Shee...
02/09/2025

Scinai Immunotherapeutics Ltd. Reports 1H 2025 Results: Highlighting CDMO Revenue Growth and a Strengthened Balance Sheet

Scinai kicked off 2025 with strong financial and operational momentum, particularly within our CDMO business unit, Scinai BioServices.

1H 2025 Highlights:

- Revenues totaled $773,000 compared to $284,000 for the six months ended June 30, 2024. The increase reflects the continued growth of the Company's CDMO business, which generated contract revenues.
- Cash position increased as we successfully raised an additional $4.2 million through our Standby Equity Purchase Agreement with Yorkville Advisors
- Scinai filed patents for four additional NanoAbs from its collaboration with the Max Planck Society and University Medical Center Göttingen and is exercising its exclusive option to license them.

These results reflect Scinai’s focused ex*****on on our dual strategy of advancing a pipeline of novel biologics for I&I indications as well as scaling CDMO operations to serve the growing needs of biopharma innovators.

Read the full press release: https://www.prnewswire.com/news-releases/scinai-reports-six-month-2025-financial-results-highlighting-continued-cdmo-revenue-growth-and-strengthened-balance-sheet-302543710.html

This August for Psoriasis Awareness Month, we’re highlighting Scinai’s work to advance NanoAbs, nanosized antibodies des...
14/08/2025

This August for Psoriasis Awareness Month, we’re highlighting Scinai’s work to advance NanoAbs, nanosized antibodies designed for high stability and precise targeting, starting with an Anti‑IL‑17 program in preclinical development for psoriasis.

With in‑house GMP biologics CDMO capabilities and strong collaborations, we’re building an ex*****on engine to move novel inflammation therapeutics from bench to bedside.

Follow Scinai for progress updates and partnering opportunities. Visit us at our website: https://www.scinai.com/

What Are NanoAbs and Why Do They Matter? NanoAbs are single-domain antibodies derived from alpacas that consist solely o...
07/08/2025

What Are NanoAbs and Why Do They Matter?

NanoAbs are single-domain antibodies derived from alpacas that consist solely of a heavy chain, in contrast to traditional monoclonal antibodies (mAbs), which contain both heavy and light chains. This streamlined structure gives NanoAbs a range of unique and advantageous properties:

✅ 10X Smaller Than Conventional mAbs – Their compact size enables lower production costs and may reduce off-target binding and side effects.
✅ High Stability – NanoAbs retain biological activity in harsh environments, which supports a simplified supply chain and longer shelf life.
✅ Flexible Administration Routes – Effective for both localized (e.g., intradermal or inhalation) and systemic treatments, enhancing their therapeutic versatility.
✅ Versatile Protein Engineering – NanoAbs function like Lego blocks, allowing scientists to design innovative molecular architectures such as monomers for local delivery or multi-specific constructs for systemic use. In contrast, traditional mAbs are more rigid—like Playmobil figures—offering far less design flexibility.

Why This Matters for Investors?

✅ Massive Market Opportunity – The psoriasis biologics market alone is projected to exceed $35 billion by 2030, with broader potential in autoimmune and inflammatory diseases.
✅ Disruptive Technology Platform – Scinai’s NanoAb platform delivers clear advantages over conventional antibody therapies, thanks to its smaller size, higher stability, modularity, and expanded administration options.
✅ Focused and Scalable Pipeline – Our lead IL-17 A/F NanoAb program targets psoriasis and other inflammatory indications, while additional candidates are advancing toward clinical readiness.

Scinai is building a next-generation NanoAb platform, combining scientific innovation with strategic focus, to unlock exceptional value in a rapidly growing global market.

Learn more about Scinai Immunotherapeutics
🔗 https://www.scinai.com/

Address

Jerusalem

Opening Hours

Monday 09:00 - 17:00
Tuesday 09:00 - 17:00
Wednesday 09:00 - 17:00
Thursday 09:00 - 17:00
Sunday 09:00 - 17:00

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Phase 3 Clinical Trials of M-001 Universal Flu Vaccine candidate

BiondVax (NASDAQ: BVXV) is a Phase 3 clinical stage biopharmaceutical company developing a universal flu vaccine. The proprietary technology of the vaccine candidate, called M-001, utilizes a unique combination of conserved and common influenza virus peptides designed to provide multi-season and multi-strain protection against current and future, seasonal and pandemic influenza. In a total of 7 completed Phase 1/2 and Phase 2 clinical trials, covering 818 participants, the vaccine has been shown to be safe, well-tolerated, and immunogenic. An additional Phase 2 trial is being conducted by the NIH/NIAID is the US. As well, BiondVax is currently conducting a large pivotal clinical efficacy Phase 3 trial in Europe. Please visit www.biondvax.com.