JERUSALEM - Scinai Immunotherapeutics Ltd. (NASDAQ:SCNI), a biotech firm specializing in inflammation and immunology therapies, announced today the successful preclinical study results of its anti IL-17A/F NanoAb for treating mild to moderate plaque psoriasis. The company's novel approach aims to provide a local treatment for a condition affecting approximately 13 million patients across major markets, including the US and Japan.
Current treatments for mild to moderate plaque psoriasis often involve topical corticosteroids or phototherapy, which can lead to side effects or low patient adherence. Scinai's product candidate is designed to be injected directly into psoriatic lesions, potentially reducing the frequency of treatment and side effects associated with existing therapies.
The study, led by Prof. Amos Gilhar at the Technion Israel Institute of Technology, compared Scinai's NanoAb with two approved drugs, Betamethasone and Secukinumab, and a control NanoAb. Results showed that Scinai's NanoAb reduced levels of IL-17 isoforms and had an anti-inflammatory effect comparable to the comparator drugs, suggesting potential as an intralesional treatment for plaque psoriasis.
Dr. Tamar Ben-Yedidia, Scinai's Chief Scientist, highlighted the significance of these findings for the large number of patients with mild to moderate psoriasis who are currently underserved by existing treatments. The company plans to refine dosing and drug half-life in further in-vivo studies in late 2024, followed by pre-clinical toxicology studies and a first-in-human clinical trial anticipated in late 2025.
Scinai also operates a Contract Development and Manufacturing Organization (CDMO) business unit, providing drug development and clinical trial services. The press release statement emphasized the company's commitment to addressing unmet medical needs in autoimmune diseases, focusing on those with milder cases.
The company's forward-looking statements in the press release are subject to risks and uncertainties, including potential delays in research and development activities, clinical trials, and the commercialization process. Scinai's future plans are contingent upon continued compliance with regulatory requirements and market conditions.
In other recent news, Scinai Immunotherapeutics Ltd. has been navigating compliance challenges with Nasdaq's listing requirements. The biopharmaceutical company has been granted an extension by the Nasdaq Hearings Panel to meet the exchange's listing requirements by August 14, 2024. Despite regaining compliance with Nasdaq's minimum bid price requirement, Scinai still confronts challenges with Nasdaq's minimum shareholders' equity requirement.
The company has received a non-binding Letter of Intent from the European Investment Bank (EIB), proposing to convert approximately $27.6 million of EIB's loan into equity. This conversion is expected to rectify the company's shareholders' deficit, creating an estimated equity surplus of around $14.5 million. The implementation of these terms is contingent upon formal approval from EIB's governing bodies and satisfaction of conditions precedent.
Additionally, Scinai reported a net loss of $2,159 thousand for Q1 2024, a decrease from the previous year's net loss. The company's Contract Development and Manufacturing Organization (CDMO) business unit received work orders worth around $500K in the first half of 2024, maintaining its sales guidance for the year at $1.25 million. Scinai is also advancing the preclinical development of its NanoAb pipeline, including promising studies for the treatment of plaque psoriasis.
InvestingPro Insights
Scinai Immunotherapeutics Ltd. (NASDAQ:SCNI) has shown promise with its recent preclinical study results, which could potentially revolutionize the treatment for mild to moderate plaque psoriasis. As the company prepares for further in-vivo studies and eventual clinical trials, investors and stakeholders are closely monitoring its financial health and market performance. Here are some key metrics and InvestingPro Tips to consider:
InvestingPro Data shows a challenging financial landscape for Scinai, with a market capitalization of just 1.89 million USD and a negative P/E ratio, reflecting the company's current lack of profitability. Moreover, the company's one-year price total return stands at a steep -72.0%, indicating a significant decline in the stock's value over the past year. Despite these hurdles, the company has experienced a strong return over the last week, with a 34.85% increase, suggesting a potential turnaround or positive market reaction to recent news.
The InvestingPro Tips highlight that Scinai operates with a significant debt burden and is quickly burning through cash, which may raise concerns about its long-term financial sustainability. However, on a positive note, the company's liquid assets exceed its short-term obligations, providing some level of financial stability in the near term. It is worth noting that Scinai does not pay a dividend to shareholders, which is not uncommon for biotech firms that are focusing on growth and reinvestment.
For readers looking to delve deeper into Scinai's financials and market potential, there are additional InvestingPro Tips available at https://www.investing.com/pro/SCNI. These tips could provide valuable insights for making informed investment decisions. Interested users can also take advantage of a special offer using the coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription. In total, there are 11 additional InvestingPro Tips listed, offering a comprehensive analysis of Scinai's financial and market position.
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