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
Israel.
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 3% of the global population suffers from
psoriasis, and the 78% of those patients who experience mild to
moderate symptoms are largely underserved by existing
treatments.
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 $1.3
million in a follow-on offering, and just last week
announced entry into a warrant exercise agreement with anticipated
gross proceeds of $1.69 million.
Moreover, we were awarded a non-dilutive grant from the Israel
Innovation Authority covering 66% of the costs of an approximately
US$900,000 project to develop our
CDMO capabilities and are aggressively pursuing additional
non-dilutive funding opportunities.
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 Jerusalem, if at all or when
required; the risk that the manufacturing facility will not be able
to be used for a wide variety of applications and other vaccine and
treatment technologies; and the risk that drug development involves
a lengthy and expensive process with uncertain outcomes. More
detailed information about the risks and uncertainties affecting
the Company is contained under the heading "Risk Factors" in the
Company's Annual Report on Form 10-K filed with the Securities and
Exchange Commission ("SEC") on April 17,
2023, and the Company's subsequent filings with the SEC.
Scinai undertakes no obligation to revise or update any
forward-looking statement for any reason.
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SOURCE Scinai Immunotherapeutics Ltd.