The roundtable was convened at the request of the Manufacturers Association to facilitate a realistic, fact-based discussion on Israel's biopharma development and manufacturing ecosystem, with a particular focus on early- stage development, CMC activities, and clinical manufacturing across the full development continuum. The discussion will emphasize early-stage development and clinical manufacturing, including access to laboratory infrastructure, CMC and analytical capabilities, and GMP manufacturing for c ...

Core Insights - Scinai Immunotherapeutics Ltd. reported financial results for the nine months ended September 30, 2025, highlighting significant progress in both its CDMO and R&D business units [1][13]. Financial Summary - As of September 30, 2025, cash, cash equivalents, and short-term deposits totaled $3,005 thousand, an increase from $1,964 thousand as of September 30, 2024 [3]. - Revenues for the nine months ended September 30, 2025, were $1,049 thousand, compared to $452 thousand for the same period in 2024, reflecting growth in Scinai Bioservices [7]. - R&D expenses decreased to $1,799 thousand from $4,195 thousand year-over-year, primarily due to lower employee and facility cost allocations [7]. - Marketing, general, and administrative expenses increased to $1,929 thousand from $1,767 thousand, mainly due to insurance reimbursements recorded in 2024 [7]. - The net loss for the nine months ended September 30, 2025, was $6,244 thousand, compared to a net profit of $7,026 thousand for the same period in 2024, largely due to financial income from loan conversion recognized in 2024 [7]. Business Update - Scinai Bioservices is expanding its role as a boutique CDMO, serving early-stage biotech companies in Israel, the U.S., and Europe [4]. - The company received a non-dilutive grant of approximately NIS 809,000 (about $246,000) from the Israel Innovation Authority to fund part of an investment in an advanced sterile fill-and-finish system [8]. - The new system aims to enhance small-batch manufacturing capacity for early-stage biotech clients, with installation expected in Q1 2026 and commercial operations planned for Q2 2026 [8]. R&D Developments - Scinai is advancing its NanoAb pipeline focused on inflammation and immunology, with two STEP grant applications of up to €15 million each, with decisions expected in Q1 2026 [6]. - The lead program, SCN-1, is approaching Phase 1/2a for mild-moderate psoriasis, with a grant application decision expected in Q1 2026 [7]. - The company is evaluating the future of the PC111 program after its €12 million grant application was not approved, considering alternative funding routes or potential termination of the acquisition option for Pincell Srl [10][11]. Partnering Outlook - Scinai is actively seeking partnerships for co-development, licensing, or broader collaborations across all pipeline programs [12]. CEO Statement - The CEO emphasized significant progress in 2025, noting the strengthening of CDMO operations and the ongoing evaluation of strategic paths for R&D programs, particularly in light of recent grant outcomes [13].

Core Insights - Scinai Bioservices has received a non-dilutive grant of approximately NIS 809,000 (about $246,000) from the Israel Innovation Authority to fund 66% of a NIS 1.23 million ($373,000) project aimed at enhancing its fill-and-finish capabilities, addressing a significant gap for early-stage biotech companies [1][2][5] Group 1: Company Developments - The grant will enable Scinai to acquire and install an advanced fill-and-finish system for sterile manufacturing, which is crucial for local biotech firms that currently face high costs and long lead times when outsourcing overseas [1][4] - Scinai's CDMO operations, initiated in 2023, have already provided high-quality manufacturing support to various biotech companies, emphasizing close collaboration and rapid project initiation [4][6] - The planned expansion supported by the grant will enhance Scinai's ability to deliver agile, small-batch, end-to-end CDMO services compliant with EMA and FDA cGMP standards [4][5] Group 2: Industry Context - Israel's biopharma sector, comprising over 300 companies, is underserved by full-service CDMOs, a challenge that is also prevalent globally among early-stage biotech innovators [3] - Scinai aims to fill this gap by offering flexible CDMO solutions that support drug development from early clone selection through to GMP drug substance and product manufacturing [3][6] - The company focuses on providing personalized, agile, and cost-effective solutions to early-stage biotech clients in Israel, the U.S., and Europe, which is often not prioritized by larger CDMOs [6] Group 3: Future Plans - The installation and qualification of the new filling system are expected to be completed by Q1 2026, with commercial operations planned for Q2 2026 [7] - Scinai's R&D unit is also advancing novel biological drug candidates for inflammatory and immunological diseases, indicating a dual focus on both manufacturing and drug development [8][9]

(Primary Standard Industrial Classification Code Number) Israel 2836 Not Applicable As filed with the United States Securities and Exchange Commission on September 22, 2025. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Scinai Immunotherapeutics Ltd. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Copies of all communications, ...

FORM F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Scinai Immunotherapeutics Ltd. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Israel 2836 Not Applicable As filed with the United States Securities and Exchange Commission on September 22, 2025. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 (I.R.S. Employer Identificatio ...

Financial Performance - Total revenues for the six months ended June 30, 2025, were $773,000, a 172% increase compared to $284,000 for the same period in 2024[5] - Gross loss for the six months ended June 30, 2025, was $(1,270,000), compared to a gross loss of $(164,000) for the same period in 2024[5] - Net loss for the six months ended June 30, 2025, was $(4,134,000), compared to a net loss of $(4,481,000) for the same period in 2024, reflecting a 7.7% improvement[5] - The Company reported an operating loss of $3,763 thousand and negative cash flows from operating activities of $2,575 thousand for the six months ended June 30, 2025[18] - For the six months ended June 30, 2025, total share-based compensation was $270, a decrease of 18.9% compared to $333 for the same period in 2024[34] - The basic net loss per share for the six months ended June 30, 2025, was calculated using a weighted average number of shares of 6,364,731,650[39] Expenses - Research and development expenses for the six months ended June 30, 2025, were $1,237,000, a decrease of 56% from $2,788,000 in the same period of 2024[5] - Total operating expenses for the six months ended June 30, 2025, were $2,493,000, down 34% from $3,791,000 in the same period of 2024[5] Assets and Liabilities - Cash and cash equivalents as of June 30, 2025, were $989,000, down 50% from $1,964,000 as of December 31, 2024[2] - Total current assets decreased to $1,506,000 as of June 30, 2025, from $2,391,000 as of December 31, 2024, representing a 37% decline[2] - Total liabilities increased to $4,982,000 as of June 30, 2025, compared to $3,471,000 as of December 31, 2024, indicating a 43% rise[4] - Total shareholders' equity decreased to $7,858,000 as of June 30, 2025, from $9,977,000 as of December 31, 2024, a decline of 21%[4] Business Operations - The company is focused on R&D and CDMO business units, with ongoing collaborations with the Max Planck Society and University Medical Center Gottingen[12] - The CDMO business is in early stages, with revenues of approximately $421 thousand generated from Scinai Bioservices for the six-month period ended June 30, 2025[15] - Revenues from CDMO recognized over time amounted to $182 for the six months ended June 30, 2025, slightly up from $180 in 2024[41] Grants and Funding - The Company submitted a €12 million grant application to fund approximately 80% of the costs for the next stage of PC111 development, which has received Orphan Drug Designation from the EMA[16] - The Company has received approximately $6,160 thousand in grants from the Israeli Innovation Authority, with $1,587 thousand supporting the CDMO business[25] - The maximum royalty amounts payable by the Company as of June 30, 2025, is approximately $5,161 thousand, representing the total gross amount of grants received[26] - The Company entered into a Standby Equity Purchase Agreement with YA II PN, Ltd. to purchase up to $10 million of ADSs during a 36-month period[31] - The Company raised approximately $1,492 in gross proceeds through drawdowns under the Purchase Agreement at a volume-weighted average price of approximately $2.9 per ADS, reflecting a 3% discount to the market price at the time[32] - In July and August 2025, the Company raised $4,203 in proceeds through drawdowns under the Standby Equity Purchase Agreement, issuing 1,638,062 ADSs at a volume-weighted average price of approximately $2.57 per ADS[43] Share-Based Compensation - The Company granted 900 RSUs to employees during the six months ended June 30, 2025, with a fair value of $3, compared to 55,725 RSUs granted in the same period of 2024 with a fair value of $290[34] - As of June 30, 2025, there are $278 of total unrecognized costs related to share-based compensation expected to be recognized over a period of up to four years[35] Accounting and Compliance - The Company is currently evaluating the impact of new accounting pronouncements on its financial statements[23] - The Company has recognized issuance-related costs of approximately $100 thousand in connection with the SEPA[31] Company Structure - The Company operates as one operating segment, with the chief operating decision maker using consolidated net loss to measure segment profit or loss[42]

Core Insights - Scinai Immunotherapeutics Ltd. reported financial results for the first half of 2025, showing significant growth in revenues and a reduction in R&D expenses compared to the same period in 2024 [1][5]. Financial Summary - Revenues for the six months ended June 30, 2025, totaled $773 thousand, up from $284 thousand in the same period of 2024, indicating growth in the CDMO business [5]. - R&D expenses decreased to $1,237 thousand from $2,788 thousand year-over-year, primarily due to lower wage and facility allocations [5]. - Marketing, general, and administrative expenses increased to $1,256 thousand from $1,003 thousand, attributed to share-based payments and an insurance reimbursement recorded in 2024 [5]. - The net loss narrowed to $4,134 thousand from $4,481 thousand, reflecting higher revenues and lower R&D expenses [5]. - As of June 30, 2025, cash and cash equivalents were $989 thousand, with an additional $4.2 million raised in July and August 2025, enhancing the cash position [5]. Business Update - Scinai Bioservices, the CDMO unit, generated $421 thousand in revenues in the first half of 2025, with total service orders reaching $1.0 million [5]. - The company is advancing its anti-IL-17 NanoAb program, focusing on treatments for psoriasis with two product profiles in development [5]. - Scinai plans to apply for up to €15 million in grant financing under the EU STEP program to fund Phase 1/2a clinical trials, with a decision expected in Q1 2026 [5]. - In 2025, the company filed patents for four additional NanoAbs and is exercising its exclusive option to license them [5]. - The company signed an option agreement to acquire PinCell srl, with a related €12 million FENG grant application under review [5].

Core Insights - Scinai Immunotherapeutics Ltd. has published new peer-reviewed research confirming the efficacy and safety of PC111, a human anti-Fas Ligand monoclonal antibody, in treating pemphigus and other skin conditions [1][2][3] Scientific and Clinical Findings - The new study validates PC111's ability to prevent blister formation in humanized models of pemphigus by targeting soluble Fas Ligand, which is crucial for keratinocyte apoptosis [2][3] - PC111 has shown significant reduction in disease activity in a proprietary humanized FasL mouse model, confirming its non-immunosuppressive action at the keratinocyte level [3] - The research also indicates PC111's potential in treating Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), a severe dermatological condition [4] Market Opportunity - Current treatments for pemphigus and SJS/TEN involve chronic immunosuppression, which can have serious side effects; PC111 offers a differentiated, fast-acting, and safer therapeutic profile [5][6] - The combined market opportunity for pemphigus and SJS/TEN is estimated to exceed one billion dollars annually [6] Development Strategy - Scinai plans to advance PC111 through IND-enabling studies and clinical development, with orphan drug designation already granted in the EU and similar status sought in the U.S. [7] - The companies are exploring accelerated approval pathways that could facilitate market entry within three to four years [7] Program Structure and Leadership - The PC111 program is led by a team of experts including Prof. Carlo Pincelli and Dr. Antonino Amato, supported by Scinai's Scientific Advisory Board [8] - The efficacy of PC111 is backed by multiple peer-reviewed publications, enhancing its credibility [8] - Scinai may receive up to 80% cost coverage through a €15 million FENG grant to support development [8] Regulatory and Strategic Outlook - The combination of orphan designation, high unmet medical need, and a well-defined mechanism of action supports a realistic path toward Breakthrough Therapy designation and/or Accelerated Approval [9]

Core Viewpoint - The Italian government's regulatory approval is a significant milestone for Scinai Immunotherapeutics Ltd. in its planned acquisition of Pincell S.r.l., allowing the company to move forward with the transaction, subject to customary remaining conditions [1][2][4]. Group 1: Regulatory Approval and Acquisition Details - The Italian government granted clearance under the Golden Power regulation for Scinai's option to acquire 100% of Pincell's share capital and voting rights [2][3]. - The approval followed an assessment by the Ministry of Health and pertains to the transaction as notified on April 5, 2025, which includes licensing agreements for Pincell's intellectual property rights [3][4]. - Scinai's CEO expressed satisfaction with the regulatory clearance, emphasizing that while it is a key requirement, it does not complete the transaction, and the company is working to meet all remaining conditions [4]. Group 2: Product Development and Funding - Pincell's lead candidate, PC111, is a fully human monoclonal antibody targeting the Fas/FasL pathway, currently in development for severe dermatological conditions, including Pemphigus, Stevens-Johnson Syndrome, and Toxic Epidermal Necrolysis [4]. - PC111 has received Orphan Drug Designation in Pemphigus from the European Medicines Agency [4]. - In anticipation of the acquisition, Scinai's Polish subsidiary submitted a €12 million grant application under the European Funds for a Modern Economy program to support the next stage of PC111's development, with a decision expected by mid-July to early August 2025 [5]. Group 3: Company Overview - Scinai Immunotherapeutics Ltd. specializes in inflammation and immunology biological products and provides CDMO services through its Scinai Bioservices unit [2][6]. - The company has a dual focus: developing biological therapeutic products and offering drug development services for early-stage biotech projects [6].

SCIENTIFIC WEBINAR 2025 PC111 - A New Drug Candidate for Rare Skin Diseases: Pemphigus and SJS/TEN Pincell Acquisition Option 1 Agenda Ø Overview of Pemphigus and SJS/TEN Symptoms, implications and patho-mechanisms Ø Overview of Current Treatment Landscape Ø PC111 Deep Dive: -- Mechanism of Action -- Achievements to Date -- Comparison to Current SOC -- Safety Profile -- Combination with Existing Therapies (Risks/Benefits) -- Development Plan -- Challenges in Conducting Rare Disease Clinical Trials Ø Commerc ...