About Scinai Immunotherapeutics

Scinai Immunotherapeutics Ltd. operates as a biopharmaceutical company. The company focuses on developing, manufacturing and commercializing innovative immunotherapeutic products primarily for the treatment of infectious and autoimmune diseases. The company has executed eight clinical trials including a seven country, 12,400 participant phase 3 trial of its prior lead drug candidate, a universal influenza vaccine candidate (‘M-001’), and has built a GMP biologics manufacturing facility for biopharmaceutical products. While M-001 did not meet its clinical endpoints and is no longer under development, the company has developed a highly experienced pharmaceutical industry leadership team and built its own fully equipped biotechnology drug manufacturing site. After receiving the phase 3 trial results in Q3 2020, the company performed a turnaround process, raised capital, hired new talent (including a new CEO) and in-licensed new intellectual property, and is in the process of developing a pipeline of diversified and commercially viable products built around an innovative nanosized antibody (NanoAb) platform collaboration. NanoAbs are nanosized antibodies derived from camelid animals and are also known as VHH-antibodies or Nanobodies. On December 22, 2021, the company signed a definitive exclusive, worldwide, License Agreement (‘LA’) with the Max Planck Society (‘MPG’), the parent organization of the Max Planck Institute for Multidisciplinary Sciences, and the University Medical Center Göttingen (‘UMG’), both in Gottingen, Germany, for the development and commercialization of innovative NanoAbs for the treatment of COVID-19. The agreement provides for an upfront payment, development and sales milestones and royalties based on sales and sharing of sublicense revenues. In addition, the company signed an accompanying Research Collaboration Agreement (‘aRCA’) with MPG and UMG in the support of the abovementioned development of a COVID-19 NanoAb. The aRCA provides for monthly payments to MPG and UMG and has a term until the earlier of two years or the date the company enters into first in-human clinical trials with the COVID-19 NanoAb. On March 23, 2022, the company signed a five-year Research Collaboration Agreement (‘RCA’; collectively, with the LA and aRCA, the ‘MPG/UMG Agreements’) with MPG and UMG covering the discovery, selection and characterization of NanoAbs for up to nine molecular targets that have the potential to be further developed into drug candidates for the treatment of disease indications, such as psoriasis, psoriatic arthritis, asthma and wet macular degeneration. These are all large and growing markets with underserved medical needs. Strategy Beginning with the MPG/UMG Agreements, the company intends to implement a strategy that will build a diversified pipeline of assets along several axes, as follows: A pipeline of products for prevention and/or treatment of illnesses with large market opportunities for more effective treatments: Each product candidate originated through the MPG/UMG Agreements would be designed to interact with a target previously validated as an appropriate target for therapeutic intervention by an antibody already on the market. Each therapeutic indication nevertheless is underserved by existing antibody treatments and a large market opportunity exists for a proprietary NanoAb with improved attributes. A pipeline that would take advantage of the unique physicochemical attributes of the company’s NanoAbs, including: Nano size and physical stability – the company’s NanoAbs are approximately 1/10th the size of regular antibodies and have a durable molecular structure. This allows them to be delivered through routes of administration (e.g., intra-dermal, nasal, inhalation, etc.) not particularly amenable to regular antibodies, which are too large and/or easily break down under pressure, opening new or enlarged market opportunities for the company’s NanoAbs. Ultra high thermo-stability – the company’s NanoAbs retain biological activity even at high temperatures. This provides extended shelf life and reduces the need for cold chain shipping and storage. Extremely high binding affinity to the target with effective neutralization. Binding affinity is the likelihood that a drug molecule (e.g., a single NanoAb) will find, and attach to its designated target (e.g., a single COVID-19 virus) thereby contributing to therapeutically relevant neutralization of the target. The company’s COVID-19 NanoAb, for example, has demonstrated binding affinity and neutralization at doses anywhere from 100 to 1000 times lower than the publicly reported doses of other antibodies. This could translate to faster onset of medical efficacy or in some cases it may translate to lower required human dosage compared to other antibodies. That said, this should be demonstrated in clinical trials. High specificity - The company’s NanoAbs have high specificity to their intended target, and therefore fewer of them are expected to bind to targets other than the designated target, resulting in fewer side effects. Furthermore, and because of their relatively short half-life, any NanoAbs, that do not bind to a target are expected to be quickly degraded or excreted from the body, thus also limiting future adverse effects. A pipeline of products that can progress through the discovery stage and enter the clinic relatively quickly compared to traditional monoclonal antibody drug discovery. Traditional monoclonal antibody drug discovery entails years of research identifying and validating a target, identifying the appropriate type of molecule to interact with that target, validating that the mechanism of action can produce a therapeutically relevant benefit with a satisfactory safety profile and that the drug can be produced at an acceptable cost of goods. Together with an international management consulting firm, the company has triaged through more than 800 potential molecular targets for the company’s NanoAbs and selected those that had already been validated as targets for commercially available monoclonal antibodies. Furthermore, the company filtered for targets for disease treatments that still leave a large unmet need or a large, underserved patient population. The company then selected those targets the highest commercial value but lowest clinical development costs (small sized clinical trials with fastest timeline to in human proof of concept). The company’s collaborators at MPG/UMG have been able to generate large libraries of NanoAbs against most of the company’s pre-validated targets within the first 12 months of the collaboration and in many cases have selected from those libraries a small portfolio of candidates that meet or are close to meetinga set of pre-agreed Compound Acceptance Criteria, which the company has agreed make them potentially appropriate for further development. A pipeline of products that can be developed through the various Chemistry, Manufacturing and Controls steps (CMC) and then be produced for clinical development and potentially initial commercial volumes required for product launch at a low cost of goods at the company’s existing manufacturing facility in Jerusalem, built to GMP specifications. The company’s NanoAbs are produced in yeast, a relatively low cost and rapid production system compared to the manufacture of regular antibodies. Regular antibodies are produced in mammalian cell lines that take considerable time to establish, require a much more sophisticated production facility, have lower yields and involve more expensive processing to harvest and purify the ultimate drug substance. The company’s facility in Jerusalem is equipped to take the candidates generated by MPG/UMG and immediately begin the development of NanoAbs for pre-clinical testing and ultimately produce clinical grade NanoAbs. By conducting these activities in-house, the company will be in a position to avoid the delays and high costs typically associated with third party contract manufacturers and have more direct control over the process. If successfully implemented, this strategy would provide BiondVax with a diverse multi-dimensional pipeline that has been substantially de-risked without necessarily limiting the upside potential. The company would also expect to have considerable flexibility regarding partnering with other companies in the pharmaceutical industry, out-licensing, joint ventures and the like. The company is actively engaged in identifying and evaluating many of these opportunities. Marketing and Sales The company intends to license to, or enter into strategic alliances, with third parties in the pharmaceutical business, which are equipped to market and/or sell any products that the company acquires or develops in the future. The company may seek to establish such capabilities internally in the future, if and when appropriate, in addition to any such licensing arrangements or strategic alliances. Competition The company’s competitors include large, fully integrated pharmaceutical companies, as well as companies and academic research institutes in various developmental stages attempting to develop COVID-19 antibody therapeutics (such as Invivyd, Vir Biotechnology, and ExeVir), as well as other products for the prevention and treatment of disease targets that are the subject of the company’s broader agreement with MPG and UMG, including MoonLake Immunotherapeutics AG for the development of antibodies against psoriasis. Manufacturing The company builds, owns, and operates a biologics manufacturing facility in Jerusalem, which is capable of manufacturing GMP-compliant product candidates for use in either clinical trials or for small to medium scale commercial supply. The company has manufactured the COVID-19 NanoAbs for the company’s preclinical in vivo study in its facility, and although the company anticipates using its facility for future manufacturing of product candidates, the company may also rely on a third party CMO. Government Regulation In complying with cGMP, the company must expend time, money and effort in the areas of training, production and quality control within the company’s own organization and at the company’s contract manufacturing facilities. Among others, the FDA, HHS, Office of Inspector General, the CMS and comparable regulatory authorities in state and local jurisdictions and in other countries impose substantial and burdensome requirements upon companies involved in the preclinical and clinical development, manufacture, marketing, and distribution of drugs, such as those the company is developing. These agencies and other federal, state, and local entities regulate, among other activities, the research and development, testing, manufacture, quality control, safety, effectiveness, labeling, storage, record keeping, approval, sales, commercialization, marketing, advertising and promotion, distribution, post-approval monitoring and reporting, sampling, and export and import of the company’s product candidates. The company is also subject to the Foreign Corrupt Practices Act, or FCPA, which prohibits improper payments or offers of payments to foreign governments and their officials for the purpose of obtaining or retaining business. Environmental Matters The company’s laboratory personnel have ongoing communication with the Israeli Ministry of Environmental Protection in order to verify compliance with relevant instructions and regulations. Research and Development Expenses The company’s research and development expenses amounted to $5.7 million for the year ended December 31, 2022. History The company was founded in 2003. It was incorporated in Israel in 2003. The company was formerly known as BiondVax Pharmaceuticals Ltd. and changed its name to Scinai Immunotherapeutics Ltd. in September 2023.