Scinai Immunotherapeutics Ltd. Stock Price, News & Analysis

Scinai Immunotherapeutics (Nasdaq: SCNI) is hosting a scientific webinar on September 18, 2024, at 11 AM EDT / 18:00 Israel time. The event will focus on treating mild to moderate plaque psoriasis using intralesional injections of Scinai's novel anti-IL-17A/F VHH antibody. The panel will feature experts including Scinai's CEO and CSO, along with professors from the University Medical Center Göttingen.

The webinar will cover:

• Current plaque psoriasis treatment landscape and unmet needs
• Introduction to single domain VHH antibodies
• Scinai's pipeline and biological drug development process
• Advantages of VHH antibodies over conventional monoclonal antibodies
• Scinai's pre-clinical results and plans for clinical trials

Participants can register for the Zoom webinar and will have the opportunity to ask questions during a Q&A session.

Scinai Immunotherapeutics (Nasdaq: SCNI) has regained full compliance with Nasdaq listing requirements, specifically Rule 5550(b)(1) which mandates a minimum stockholders' equity of $2.5 million. This achievement follows the company's recent Loan Restructuring Agreement with European Investment Bank, converting approximately $29 million of debt to preferred equity. The restructuring has significantly improved Scinai's balance sheet, leaving a debt balance of only €250,000 (approximately $273,000).

CEO Amir Reichman expressed that this development allows the company to focus on its R&D programs and new CDMO business unit. However, Scinai will be subject to a Mandatory Panel Monitor for one year, during which any non-compliance with the Rule could result in immediate delisting proceedings without the opportunity for a compliance plan.

Scinai Immunotherapeutics (Nasdaq: SCNI) has closed a Loan Restructuring Agreement with the European Investment Bank (EIB), converting approximately $29 million of debt into 1,000 preferred shares. This leaves a debt balance of only $273,000, maturing on December 31, 2031, with no interest accrual or prepayment option.

The restructuring boosts Scinai's stockholders' equity above $2.5 million, potentially regaining compliance with Nasdaq Listing Rule 5550(b)(1). The preferred shares are convertible into ADSs representing 19.5% of the company's fully diluted capital, with a 12-month lock-up period and a 4.99% ownership limitation. Scinai retains the option to redeem the shares at a cumulative value of $34 million.

Scinai Immunotherapeutics (Nasdaq: SCNI) has entered into a $2 million Investment Commitment Agreement with RK Stone Miami , an affiliate of its largest shareholder, Daniel Stone. The agreement allows Scinai to issue and sell ADSs to the investor until December 31, 2024, with a minimum sale amount of $200,000 and a maximum of $500,000 per transaction. The ADS price will be calculated based on the lower of two VWAP methods, subject to a 5% discount.

The agreement includes provisions to prevent the investor from exceeding 9.99% ownership of outstanding ordinary shares, with pre-funded warrants issued if necessary. Scinai will pay a commitment fee of $100,000 if an advance notice is provided, or $40,000 if no advance is made during the commitment period. The company maintains discretion over initiating sales and is not required to register the ADSs for resale.

Scinai Immunotherapeutics (Nasdaq: SCNI) published its Q2 2024 financial results and provided a business update. Key highlights include:

1. Restructuring of a €26.6 million (~$29 million) EIB loan into equity, expected to close by August 23, 2024, to regain Nasdaq compliance.

2. CDMO business unit received work orders valued at ~$600K since January 2024, maintaining 2024 revenue guidance of $1.25 million.

3. Promising results from in-vivo proof of concept study for NanoAb in psoriasis treatment.

4. Positive regulatory feedback from PEI for Phase 1/2a clinical trial of anti-IL-17A/F nanoAb in Plaque Psoriasis.

5. Q2 2024 financial results: R&D expenses decreased to $2.79 million, net loss reduced to $4.48 million, and cash position of $3.08 million as of June 30, 2024.

Scinai Immunotherapeutics (NASDAQ: SCNI) has signed a Loan Restructuring Agreement with the European Investment Bank (EIB), converting approximately $29 million of debt into 1,000 preferred shares. These shares are convertible into 19.5% of the company's fully diluted capital. The remaining loan of about $273,000 will mature on December 31, 2031, with no interest accrual.

The preferred shares are redeemable at the company's discretion for a cumulative value of $34 million. This restructuring eliminates nearly $28 million of debt, potentially establishing a more stable financial base for Scinai's plans to develop novel therapeutics for inflammation and immunology diseases.

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.