Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI)

Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) is a biotechnology company focused on developing, manufacturing, and commercializing innovative immunotherapeutic products primarily for the treatment of infectious diseases and autoimmune diseases.

In collaboration with the prestigious Max Planck Institute for Multidisciplinary Sciences (MPG) and the University Medical Center Göttingen (UMG), both in Germany, Scinai is developing a pipeline of innovative nanosized antibody (NanoAb) therapies addressing diseases underserved by current treatments and with large and growing markets, such as COVID-19, asthma and psoriasis.

NanoAbs, also known as VHH-antibodies or Nanobodies, are alpaca-derived nanosized antibodies that exhibit multiple significant competitive advantages over existing antibody therapies, including stability at high temperatures, superior binding affinity, more effective and convenient routes of administration and efficient production. Scinai is uniquely positioned to advance nanosized antibody innovation from R&D through commercialization.

The company’s highly experienced and successful pharmaceutical industry leadership team includes former senior executives from Novartis, GSK and Bristol-Myers Squibb.

Since its founding, Scinai has executed eight clinical trials, including a seven-country, 12,400-participant Phase 3 trial of a prior influenza vaccine candidate, and it built, owns and operates a 20,000 sq. ft. state-of-the-art GMP biologics manufacturing facility housing its laboratories, production facilities and offices.

Lead Candidate: Inhaled COVID-19 NanoAb

In December 2021, Scinai signed definitive agreements with the Max Planck Society – parent organization of the Max Planck Institute for Multidisciplinary Sciences– and the UMG to enter a strategic collaboration for the development and commercialization of innovative COVID-19 NanoAbs.

The company is planning a rapid development path that leverages its expertise and capabilities in biological drug development and manufacturing. Scinai anticipates preclinical proof-of-concept results for an inhaled COVID-19 NanoAb by the end of 2022, with initial Phase 1/2a human clinical trial results expected in 2023.

The intended inhaled mechanism of delivery of Scinai’s COVID-19 NanoAb formulation may serve as a significant differentiator when compared to approved monoclonal antibodies, which are injected. Inhaled delivery has shown to be cheaper, more convenient and likely safer for patients and providers.

NanoAb Pipeline: Psoriasis, Asthma and More

The COVID-19 NanoAb development agreement is part of a broader five-year research collaboration agreement signed in March 2022 covering discovery, development and commercialization of NanoAbs for several other disease indications with large market medical needs, including asthma, psoriasis, macular degeneration and psoriatic arthritis.

Scinai has an exclusive worldwide license for development and commercialization of COVID-19 NanoAbs and exclusive options for similar worldwide licenses for NanoAbs for the above mentioned additional large market disorders currently underserved by approved therapeutic antibodies.

Academic research teams from MPG and UMG have verified strong affinity by the new NanoAbs to their biological target molecules and high thermostability. They have also demonstrated strong neutralization by several NanoAb candidates of their respective target molecules. Neutralization studies of the other NanoAbs are expected to begin later in 2022.

Based on the promising results, Scinai will focus development efforts beginning with the following NanoAbs:

• NanoAbs targeting IL-17 as drug candidates for the potential treatment of psoriasis and psoriatic arthritis
• NanoAbs targeting IL-13 and NanoAbs targeting TSLP as drug candidates for the potential treatment of asthma

These are conditions for which the antibody target is validated by existing treatments and the mechanism of action is well understood. Both represent large medical needs and growing markets. Scinai anticipates preclinical proof-of-concept for at least one of these NanoAbs in 2023. This is in addition to the aforementioned human clinical Phase 1/2a for the inhaled COVID-19 NanoAb therapy, which is also anticipated in 2023.

CDMO Services

While NanoAb pipeline development is Scinai’s core focus, the company also offers its cGMP manufacturing facility, aseptic fill and finish suite, laboratories and experienced professionals for contract development and manufacturing organization (CDMO) services. This offering is designed to keep the Scinai team abreast of the latest industry developments and trends while building experience and generating revenue to support the company’s NanoAb pipeline development.

Market Opportunity

COVID-19 treatment, target of the company’s lead NanoAb therapy candidate, had an estimated market size of $22 billion in 2021.

Future Scinai drug candidates will target conditions with large markets growing at attractive CAGRs.

The global asthma treatment market was valued at $18.08 billion in 2019 and is projected to reach $26.01 billion by 2027, exhibiting a CAGR of 4.5% during the forecast period, according to Fortune Business Insights. The research firm predicts that the global psoriasis treatment market will grow from $26.37 billion in 2022 to $47.24 billion by 2029, exhibiting a CAGR of 8.7% over the forecast period.

Management Team

Amir Reichman is Scinai’s CEO. He previously was Head of Global Vaccines Engineering Core Technologies at GSK Vaccines in Belgium. Prior to that, he held leadership roles at Novartis Vaccines’ Global Vaccines Supply Chain Management organization. He was the first employee of NeuroDerm Ltd., a company focused on transdermal drug delivery, and served as Senior Scientist until his departure in 2009. He earned a M.Sc. in Biotechnology Engineering from Ben-Gurion University and an MBA in Finance and Health Care Management from the University of Pennsylvania’s Wharton School.

Tamar Ben-Yedidia, Ph.D., is Chief Science Officer at Scinai. She has more than 30 years of experience in immunology, with specific expertise in the development of vaccines. She began her career with Biotechnology General Ltd., working on development of a recombinant Hepatitis-B vaccine. She later joined the Weizmann Institute of Science, working on the design of a peptide-based vaccine against several pathogens. She is widely published, with numerous refereed articles and invited reviews in various scientific journals. She received her Ph.D. from the Weizmann Institute.

Elad Mark is COO at Scinai. He has over 15 years of biotechnology industry experience encompassing diverse project stages including feasibility studies, conceptual and detailed design, commissioning, qualification and process validation. Prior to joining BiondVax, he led Novartis’s $800 million investment in a biologics facility in Singapore. With Biopharmax and Antero, both global pharmaceutical engineering companies, he successfully led projects in Israel, China and Singapore. He holds a BSc. in Engineering from the Afeka Tel Aviv Academic College of Engineering and an MBA from the Open University of Israel.

Uri Ben-Or is CFO at Scinai. He has served as CFO with public life science companies traded on the TASE, OTC and Nasdaq. Ben-Or provides his services to Scinai through CFO Direct, a company he founded and for which he serves as CEO. He served as the VP of Finance of Glycominds, a leading biotechnology company, and as CFO of a spin-off from Telrad Networks. He also served as a Corporate Controller at Menorah Capital Markets and as an Auditor at PWC. He holds a B.A. in Business from the College of Administration, an MBA from Bar-Ilan University, and is a CPA.