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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 been granted an extension by the Nasdaq Hearings Panel to regain compliance with continued listing requirements. The company must meet certain conditions, including filing a public disclosure by August 14, 2024, to demonstrate compliance with the equity requirement of maintaining at least $2,500,000 in stockholders' equity. Previously, on May 20, 2024, Scinai had received a notification from Nasdaq about its non-compliance. During a hearing on June 18th, the company presented a plan to convert a significant portion of its loan from the European Investment Bank into equity, which led to an extension for continued listing. However, there is no assurance that Scinai will meet the imposed deadlines or conditions.
Scinai Immunotherapeutics (Nasdaq: SCNI) announced its Q1 2024 financial results, revealing key developments and financial metrics. The company raised $1.69 million via warrants issuance in January and regained compliance with Nasdaq’s $1.00 bid price requirement in June but remains non-compliant with the equity requirement.
The CDMO unit received $500K in work orders in the first half of 2024, with projected 2024 revenues of $1.25 million. Pipeline developments include promising preclinical results for NanoAb treatments for plaque psoriasis and collaborations for COVID-19 and anti-IL-17 treatments.
Financially, Scinai reported a net loss of $2.159 million, down from $3.515 million in Q1 2023. R&D expenses decreased to $1.568 million, and marketing, general, and administrative expenses fell to $484K. As of March 31, 2024, the company held $4.826 million in cash and equivalents.
Scinai Immunotherapeutics announced it has received a non-binding Letter of Intent from the European Investment Bank to convert a $27.6 million loan into equity. This conversion involves prefunded warrants exercisable into American Depositary Shares (ADS), representing 19.5% of the company's fully diluted capital. This move is expected to eliminate a $4.5 million shareholders' deficit and create a $14.5 million equity surplus. The final terms are subject to EIB's formal approval and other legal conditions. Scinai aims to regain Nasdaq listing compliance and improve its financial standing. The conversion details will be reflected in the Q3 2024 financial reports.
Scinai Immunotherapeutics announced on June 7, 2024, that it regained compliance with Nasdaq's $1.00 minimum bid price requirement as of June 5, 2024. This achievement follows a strategic adjustment in its American Depositary Shares (ADSs) ratio, approved by the Board, which increased the number of ordinary shares represented by each ADS from 400 to 4,000 effective May 21, 2024. Consequently, the bid price exceeded $1.00 for ten consecutive business days. Despite this progress, Scinai remains non-compliant with Nasdaq's minimum shareholders' equity requirement. The company is in advanced discussions with the European Investment Bank (EIB) to convert a significant portion of its loan into equity, aiming to present this plan at a Nasdaq hearing on June 18, 2024.
Scinai Immunotherapeutics announces receipt of a Nasdaq Staff determination letter regarding noncompliance with minimum shareholders' equity requirements. A hearing with the Nasdaq Hearings Panel is scheduled for June 18, 2024, where the company will present a plan to regain compliance. The plan may include converting part of a loan from the European Investment Bank into equity. The company has also received a notification regarding noncompliance with the minimum $1.00 bid price requirement. To address this, a ratio change of the ADSs to non-traded ordinary shares was implemented, equivalent to a reverse split of 1 for 10. Despite these issues, SCNI's ADSs will continue trading under the symbol 'SCNI' pending the outcome of the hearing.
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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