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Scinai Immunotherapeutics Ltd. (Nasdaq: SCNI) is a forward-thinking biopharmaceutical company specializing in the development of inflammation and immunology (I&I) biological therapeutic products and the provision of boutique Contract Development and Manufacturing Organization (CDMO) services. The company operates two complementary business units: one focused on in-house development of a groundbreaking pipeline of nanosized VHH antibodies (NanoAbs), and the other offering comprehensive CDMO services aimed at helping biotech firms bring their products to market efficiently.
Scinai's proprietary NanoAb technology targets diseases with substantial unmet medical needs. Its flagship product is an intradermal NanoAb targeting IL-17 for treating mild to moderate plaque psoriasis. Recent successful preclinical trials have shown promising results, positioning Scinai for first-in-human clinical trials in mid-2025. Additionally, the company is developing NanoAbs for other autoimmune diseases like asthma, atopic dermatitis, and wet AMD, under exclusive licenses from renowned institutions such as the Max Planck Society and University Medical Center Göttingen.
On the CDMO front, Scinai Bioservices offers end-to-end solutions, including drug development, analytical methods development, clinical cGMP manufacturing, and trial design for early-stage biotech companies. The company’s state-of-the-art GMP facility in Jerusalem is equipped to handle a wide array of biopharmaceutical needs, from preclinical to clinical trial stages.
Scinai's financial condition is robust, supported by strategic partnerships and significant capital infusions, including a non-dilutive grant from the Israel Innovation Authority. The company has also recently secured high-profile CDMO contracts, including a five-year agreement with Ayana Pharma Ltd., expected to generate substantial revenue.
Recent achievements include successful preclinical trials for its COVID-19 NanoAb therapy, which demonstrated remarkable prophylactic and therapeutic potential. Scinai is actively seeking partnerships to advance these NanoAbs through clinical trials.
The company is led by a team of seasoned professionals with extensive experience in pharmaceutical development and commercialization. Scinai's commitment to innovation, coupled with its strategic focus on unmet medical needs and robust CDMO services, positions it as a significant player in the biopharmaceutical industry.
Scinai Immunotherapeutics has released its financial results for FY 2023, reporting a net loss of $6.5 million, an increase from $5.8 million in 2022. The company raised $1.69 million in January 2024 through warrant exercises and secured a grant from the Israel Innovation Authority covering 66% of a CDMO project. Scinai's CDMO unit reported $500K in work orders for early 2024, projecting $1.25 million in revenue for the year. In its pipeline, Scinai highlighted positive preclinical results for its anti-IL-17 NanoAbs for psoriasis and ongoing strategic partnerships for COVID-19 treatments. The company also saw a decrease in R&D and administrative expenses but reported lower financial income and reduced cash reserves of $4.9 million as of December 31, 2023.
Scinai Immunotherapeutics (Nasdaq: SCNI) has received a delisting notification from Nasdaq due to non-compliance with the minimum $1.00 bid price requirement. The company is appealing the determination and has approved a ratio change of its ADSs to non-traded ordinary shares, equivalent to a reverse split, to regain compliance. No action is required by the ADS holders for the ratio change, which is expected to be effective on May 21, 2024.
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