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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 (Nasdaq: SCNI) has established a U.S. subsidiary, Scinai Bioservices Inc., for its Contract Development and Manufacturing Services (CDMO) business unit. The company's Jerusalem facility includes 20,000 square feet of clean rooms and laboratories operating under cGMP conditions, compliant with EMA and FDA requirements.
Since launching in 2024, the CDMO unit has executed drug development projects for nine biotech companies, including process development, scale-up, and drug manufacturing services. The U.S. expansion aims to capitalize on growing demand for biological early-stage drug development services, particularly amid capacity constraints and the BIOSECURE Act's restrictions on foreign biotech companies. The company has already secured its first U.S. customer, Serpin Pharma, for clinical manufacturing support.
Scinai Immunotherapeutics (Nasdaq: SCNI) has appointed Prof. Michael Schön to its Scientific Advisory Board. Prof. Schön is currently the Director of Dermatology, Venereology, and Allergology at the University Medical Center Göttingen and serves as Vice Dean and Deputy Director for Research and Teaching. He brings extensive expertise in dermatology and immunology, with over 440 scientific publications and significant experience in treating inflammatory skin diseases.
Prof. Schön expressed enthusiasm about contributing to Scinai's innovative pipeline, particularly in addressing unmet medical needs in chronic inflammatory skin diseases. The company's CEO, Amir Reichman, highlighted Prof. Schön's expertise in psoriasis and atopic dermatitis as valuable assets for advancing Scinai's inflammation and immunology biological products pipeline.
Scinai Immunotherapeutics (Nasdaq: SCNI) has appointed Dr. Jonathan Sadeh to its Scientific Advisory Board. Dr. Sadeh, former Senior Vice President of Immunology R&D at Bristol-Myers Squibb, brings over 20 years of experience in drug development and clinical research. He will focus on advancing Scinai's lead IL-17 program and VHH antibody pipeline. At BMS, he led multiple drug approvals, including Sotyktu for psoriasis. Dr. Sadeh previously held senior positions at Sanofi, AstraZeneca, and Schering-Plough, and earned his MD from Mount Sinai School of Medicine and M.Sc. from Harvard Medical School.
Scinai Immunotherapeutics (NASDAQ: SCNI) reported financial results for the nine months ended September 30, 2024. The company's shareholders' equity improved to positive $10 million from negative $7.3 million, primarily due to the conversion of a EUR 26.6 million EIB loan into preferred shares. Revenue reached $452,000, compared to no revenues in the same period of 2023. The company reported a net gain of $7,026,000 versus a net loss of $4,170,000 in the previous year. Cash position decreased to $1,169,000 from $5,010,000. The CDMO business unit received work orders valued at approximately $600,000 and expects material revenue growth in coming years.
Scinai Immunotherapeutics (Nasdaq: SCNI) announced its participation in the BIO-Europe 2024 conference in Stockholm, Sweden, from November 4-6. The company's leadership team will showcase their cGMP biologics CDMO services and innovative I&I pipeline. CEO Amir Reichman and CTO Dr. Dalit Weinstein-Fischer will hold meetings with potential CDMO clients, pharma partners interested in NanoAbs and dermatology programs (including their psoriasis treatment), and investors. The company will be exhibiting at booth #150.
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.
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