Scinai Immunotherapeutics Ltd. American Depositary Shares - SCNI STOCK NEWS

Scinai Immunotherapeutics (NASDAQ: SCNI) has received positive regulatory feedback from the Paul Erlich Institute (PEI) for its anti-IL-17A/F nanoAb (SCN-1) drug development program in Plaque Psoriasis. Key points include:

1. Toxicology studies can be conducted in pigs instead of non-human primates.
2. Phase 1/2a clinical trial can assess both safety and efficacy, skipping healthy volunteer testing.
3. Comparison of SCN-1 to placebo on the same human subject is approved.
4. Manufacturing process and specifications are deemed acceptable.

The Phase 1/2a study, expected to include 24 patients, is planned for the second half of 2025 with results in 2026. This feedback could lead to significant time and cost savings in Scinai's drug development plans for mild to moderate plaque psoriasis treatment.

Scinai Immunotherapeutics (Nasdaq: SCNI) has announced promising results from an in-vivo preclinical study of its anti IL-17A/F VHH antibody fragment ('NanoAb') for treating mild to moderate plaque psoriasis. The study, conducted by Prof. Amos Gilhar's team at the Technion, used a human skin transplant model on mice to compare Scinai's NanoAb with approved drugs.

Key findings include:

• NanoAb's ability to neutralize both IL-17A and IL-17F isoforms was confirmed in-vivo
• The anti-inflammatory effect was similar to comparator drugs
• Results support the potential of intralesional NanoAb injection to reduce psoriatic lesion severity

Scinai plans further studies in late 2024 and aims for a first-in-human clinical trial in late 2025.

Scinai Immunotherapeutics has received an updated Letter of Intent (LoI) from the European Investment Bank (EIB) for converting a major portion of its loan into equity. The conversion involves converting $28 million of the loan into Preferred Shares, which are convertible into American Depositary Shares (ADSs), representing 19.5% of the company's fully diluted capital. The new terms eliminate variable remuneration and mandatory dividends, making the terms favorable for Scinai. The company aims to address Nasdaq's minimum shareholders' equity requirement and has presented a plan to regain compliance. The updated LoI needs approval from EIB's governing bodies and an amendment to Scinai's articles of association. The company plans to hold a shareholder meeting on August 12, 2024, to authorize these changes.

Scinai believes this conversion will significantly reduce its long-term liabilities and improve its financial standing. The conversion is expected to eliminate a shareholders' deficit of $5.1 million, creating a surplus in shareholders' equity. The company plans to file the necessary financial statements for Q2 2024 to ensure compliance with Nasdaq's requirements.

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.