Scinai Immunotherapeutics CEO Issues Letter to Shareholders
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Insights
Scinai Immunotherapeutics Ltd.'s recent announcement regarding successful preclinical trial results for its anti-IL-17 NanoAb psoriasis therapy represents a potentially pivotal development in the company's pipeline. The progression of a biopharmaceutical firm's product through the trial phases often correlates with its market valuation, as investors seek to anticipate the future revenue streams that successful products can generate. Notably, psoriasis is a chronic condition affecting millions globally and the demand for effective treatments is substantial. The success in preclinical trials indicates a positive trajectory, but it is critical to remain aware that the majority of compounds do not make it through the subsequent phases of clinical trials. Moreover, the market for psoriasis treatments is competitive, with several established players. The true test will be how Scinai's therapy compares in efficacy and safety to existing treatments and whether it can secure a meaningful market share upon approval.
Anti-IL-17 therapies, such as the NanoAb being developed by Scinai, target a pro-inflammatory cytokine implicated in the pathogenesis of psoriasis. By inhibiting IL-17, these therapies can reduce inflammation and plaque formation, which are hallmarks of the disease. The success in preclinical trials suggests that Scinai's NanoAb may have a favorable safety profile and efficacy. However, the transition from preclinical to clinical efficacy is not guaranteed. The therapeutic landscape for psoriasis includes biologics, PDE4 inhibitors and topical treatments, each with varying mechanisms of action. The differentiation of Scinai's product will hinge on its clinical trial results, particularly in terms of long-term safety and the ability to improve patients' quality of life. Stakeholders should monitor the upcoming clinical trials for indicators of potential market disruption.
In evaluating the impact of Scinai Immunotherapeutics' developments on the broader market, it is essential to consider the competitive landscape of the I&I sector. While the successful preclinical trial results are promising, the psoriasis market is already well-established, with multiple therapies available. The company's ability to capture market share will depend on the NanoAb's differentiation in terms of efficacy, safety and cost-effectiveness. Additionally, payer acceptance and physician prescribing habits are crucial factors that will ultimately influence the commercial success of the therapy. If Scinai can demonstrate clear advantages over existing treatments and navigate the pricing and reimbursement environment effectively, there could be significant implications for market dynamics within the psoriasis treatment space.
JERUSALEM , Jan. 4, 2024 /PRNewswire/ -- Scinai Immunotherapeutics Ltd. (Nasdaq: SCNI), a biopharmaceutical company focused on development of inflammation and immunology (I&I) biological products, today published a letter from its CEO, Amir Reichman, addressing the Company's 2023 accomplishments, including successful preclinical trial results of its anti-IL-17 NanoAb psoriasis therapy and 2024 plans.
The Company will host a webinar on January 9th to expand on the content of the letter and invites you to submit questions both ahead of and during the webinar. To register for the webinar please follow this link: https://us02web.zoom.us/webinar/register/6017030839657/WN_7HRajnRKQPCjEw0tBR-FPA.
The CEO letter reads as follows:
Dear Scinai Shareholders,
Throughout 2023, I communicated my optimism about Scinai's future growth, including our potential to deliver value to our shareholders, stakeholders and partners. It was a year in which we successfully embarked on our new direction and achieved clear and concrete scientific and business milestones, even against the challenging background of turbulent markets and war here in
PIPELINE DEVELOPMENT >
I'd like to start with highlighting our most recent and, in my mind, most exciting achievement:
A recently completed ex-vivo study indicates the potential of our anti-IL-17 VHH antibody ('NanoAb') to effectively and conveniently treat mild to moderate plaque psoriasis.
Approximately
While current biologic treatments can be highly effective, they are expensive, require systemic administration through periodic injections and since they can result in severe side effects are approved only for moderate to severe psoriasis. Existing medications for mild to moderate cases predominantly consist of generic localized treatments that do not effectively relieve symptoms or halt disease progression.
The study results represent an important milestone in our mission to address significant unmet needs by developing a safe and effective biologic solution designed especially for mild to moderate psoriasis patients. We believe that our NanoAb will provide distinct benefits tailored to these patients' particular needs, such as convenient local administration directly where needed, when needed, rather than chronic systemic administration of a biologic drug. In addition, we expect our NanoAb to allow superior manufacturing and supply chain efficiencies compared to current biologics, thereby further enhancing its value to patients, providers and payers.
Professor Amos Gilhar of the Technion Israel Institute of Science, who was not involved in this ex-vivo study but has been contracted by Scinai to conduct an in-vivo study, reviewed the study results and noted that Scinai's NanoAbs displayed "potential as anti-inflammatory agents in psoriasis, particularly in improving skin viability and structure." Furthermore, he noted the study indicated that just a single dose "might have been potent enough to block all IL-17, effectively 'shutting down' the immediate flare-up. This immediate response suggests a direct and effective inhibition of the existing IL-17 cytokines."
Based on the positive results of this study, Scinai recently initiated an in-vivo proof of concept study in xenograft mice expressing psoriasis to test the efficacy and duration of effect of its anti–IL–17 NanoAb. Next, Scinai expects to commence toxicology studies which are required to receive regulatory approval to proceed with a first-in-human clinical trial, which Scinai expects to initiate early next year.
Psoriasis treatment study results > https://www.scinai.com/press-releases/scinai-announces-promising-results-in-a-psoriatic-human-skin-model
Our focus on IL-17 follows the successful preclinical results of our inhaled COVID-19 NanoAb studies, which showed both prophylactic protection (COVID-19 illness was shown to have been virtually prevented in hamsters administered our inhaled NanoAb and infected three hours later with SARS-CoV-2) and therapeutic effectiveness (treatment initiated one day post infection led to significantly milder illness, faster recovery, and lower viral lung titer in comparison to the placebo group). These studies demonstrated the potential of our NanoAbs to prevent and treat hyper infectious viral respiratory diseases, to be effective and safe at low doses, and to deliver via inhalation, a uniquely convenient route of administration. We are actively seeking partnerships to bring our COVID NanoAbs through clinical trials.
COVID-19 NanoAb study > https://www.scinai.com/press-releases/study-published-in-antiviral-research-supports-promise-of-scinai-immunotherapeutics-coronavirus-nanoab-as-aerosolized-prophylactic-and-therapeutic-drug
SCINAI BIOSERVICES CDMO BUSINESS UNIT >
Scinai's broad experience, along with our end-to-end biologics drug development and GMP manufacturing assets, naturally drove another key 2023 strategic development: Launch of Scinai Bioservices, our boutique end-to-end CDMO business unit, to assist biotech companies efficiently bring their products to market. In Q4 2023 we signed our first two clients, and we are in advanced discussions with several other potential clients. We expect Scinai Bioservices to grow and generate revenues in support of our NanoAb pipeline development.
New CDMO Business Unit > www.scinai.com/cdmo
CAPITAL INFUSIONS >
In support of our plans into 2024 and beyond, the European Investment Bank (EIB) extended the maturity of its financial facility with Scinai from 2027 to December 31, 2031. This extension provides us with time to develop our pipeline and build our CDMO business without undue near-term financial pressure of an earlier maturity date and signaled the EIB's support for our business plans.
In addition, despite difficult market conditions, in September we raised gross proceeds of
EIB financial relief > https://www.scinai.com/press-releases/european-investment-bank-eib-extends-maturity-of-its-finance-facility-with-scinai-immunotherapeutics-from-2027-to-2031
NEW NAME AND BRAND >
Against the backdrop of our NanoAb pipeline development and creation of our CDMO business unit, and to reflect our new direction, we launched our new 'Scinai' brand. Scinai's name, branding and logo have been enthusiastically celebrated both by internal and external stakeholders.
Scinai > I invite you to watch our videos that revealed our new brand and explain our vision
LOOKING FORWARD IN 2024 >
In 2024, Scinai plans to build on 2023's momentum. We plan to complete the necessary requirements, including in-vivo and toxicology studies and GMP manufacturing, to initiate human clinical trials for our anti-IL-17 NanoAb by early next year. We also intend to grow our CDMO business, further strengthen our pipeline through our ongoing collaboration with Max Planck and UMG and pursue business development and partnerships in order to build long-term value for our CDMO customers, patients, and our investors.
On January 9, 2024, we will host a webinar to expand on our 2023 accomplishments and 2024 plan. Space is limited, so I encourage you to register now at https://us02web.zoom.us/webinar/register/6017030839657/WN_7HRajnRKQPCjEw0tBR-FPA. I invite you to submit questions you'd like us to address during the webinar to me at amir.reichman@scinai.com or to our Investor Relations Director, Joshua Phillipson, at joshua.phillipson@scinai.com
Thank you for joining us as we continue to build Scinai into a success by providing caregivers and patients with high quality, innovative, de-risked, pharmaceutical products that help protect and improve human life. On behalf of Scinai's team, I wish you a peaceful and successful 2024.
Sincerely,
Amir Reichman, CEO
Scinai Immunotherapeutics Ltd.
About Scinai Immunotherapeutics
Scinai Immunotherapeutics Ltd. (Nasdaq: SCNI) is a biopharmaceutical company with two complementary business units, one focused on in-house development of inflammation and immunology (I&I) biological therapeutic products beginning with an innovative, de-risked, pipeline of nanosized VHH antibodies (NanoAbs) targeting diseases with large unmet medical needs, and the other a boutique CDMO providing services to help biotech companies efficiently bring their products to market by leveraging Scinai's drug development and GMP and non-GMP manufacturing capabilities for pre-clinical and clinical studies. Company website: www.scinai.com.
Company Contact
Joshua Phillipson | +972 8 930 2529 | joshua.phillipson@scinai.com
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Litigation Reform Act of 1995. Words such as "expect," "believe," "intend," "plan," "continue," "may," "will," "anticipate," and similar expressions are intended to identify forward-looking statements. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, the timing of an in-vivo study and a clinical trial, the growth of our CDMO business and the in-license another NanoAb. These forward–looking statements reflect management's current views with respect to certain current and future events and are subject to various risks, uncertainties and assumptions that could cause the results to differ materially from those expected by the management of Scinai Immunotherapeutics Ltd. Risks and uncertainties include, but are not limited to, the risk of delay in, or Scinai's inability to conduct, its research and development activities, including the contemplated in-vivo and toxicology studies and a clinical trial, the risk that Scinai will not remain listed on Nasdaq; the risk that Scinai will not be successful in growing its CDMO business or in-license other NanoAbs; the risk that Scinai may not be able to secure additional capital on attractive terms, if at all; the risk that the therapeutic and commercial potential of NanoAbs will not be met; the risk of a delay in the preclinical and clinical trials data for NanoAbs, if any; the risk that our business strategy may not be successful; the risk that the European Investment Bank (EIB) may accelerate the financial facility under its finance contract with Scinai; Scinai's ability to acquire rights to additional product opportunities; Scinai's ability to enter into collaborations on terms acceptable to Scinai or at all; timing of receipt of regulatory approval of Scinai's manufacturing facility in
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SOURCE Scinai Immunotherapeutics Ltd.
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