• Scinai Immunotherapeutics recently announced the closing of a registered direct offering, raising $1.33 million in gross proceeds
• The company intends to use the net proceed from the offering for, among others, research and development
• On its R&D agenda is the development and commercialization of novel innovative NanoAbs targeting a wide range of diseases with known and validated antibody drug targets
• This strategic approach is expected to shorten development timelines, reduce the budgetary requirements, and increase probability of drug approval
• The company has also expanded into the CDMO business to plug an existing gap in the market, raising recurring revenue as a result

Biopharmaceutical company Scinai Immunotherapeutics (NASDAQ: SCNI) recently raised $1.33 million in gross proceeds from its previously announced registered direct offering of 1,146,522 of its American Depositary Shares (“ADSs”) (or ADS equivalents), which closed September 19. Moreover, in a concurrent private placement, the company issued unregistered warrants to purchase up to 1,146,522 ADSs representing ordinary shares. Each ADS represents 400 ordinary shares and was available at a purchase price of $1.16 per ADS (or ADS equivalent). Scinai intends to use the net proceeds from the offering for, general working capital, general corporate purposes, and research and development (“R&D”) (https://ibn.fm/ccWGG).

The company, which is focused on developing, manufacturing, and commercializing biological products for the treatment of autoimmune and infectious diseases, has in the recent past directed its R&D efforts toward the development and eventual commercialization of novel, innovative alpaca-derived nanosized antibodies (“NanoAbs”), also known as VHH-antibodies.

These efforts are rooted in a strategic research collaboration agreement between Scinai Immunotherapeutics and the Max Planck Society, the parent organization of the Max Planck Institute for Multidisciplinary Sciences (“MPI”), and the University Medical Center Göttingen (“UMG”), both in Germany for the development of the NanoAbs. Based on the agreement, Scinai has an exclusive option for an exclusive worldwide license at pre-agreed commercial terms for further development and commercialization of each generated NanoAb (https://ibn.fm/CV5XI).

The company recently exercised the exclusive option, signing an exclusive license agreement for the development and commercialization of a novel anti-IL-17 antibody for the treatment of autoimmune and inflammatory diseases, including psoriasis. Scinai is aggressively advancing the NanoAb preclinical development with the expectation that the IL-17 NanoAb will potentially enter clinical testing in 2024, with ex vivo proof-of-concept studies expected later this year (https://ibn.fm/OPSAU).

NanoAbs exhibit multiple valuable competitive advantages over existing monoclonal antibody (“mAb”) therapies, including stability at high temperatures, potential for more effective and convenient routes of administration, and uniquely strong binding affinity. They have superior specificity and affinity to particular targets, potentially enabling lower doses, hence lowering cost and reducing adverse side effects, if any. Moreover, NanoAbs are hyper-thermostable, a property that prolongs their shelf life and eases storage and distribution. Perhaps most importantly, NanoAbs exhibit potential as ‘biobetter’ therapies for a wide range of diseases with known and validated antibody drug targets, a strategic approach expected to shorten development timelines while increasing the probability of drug approval.

Speaking during an episode of the Test. Optimize. Scale. podcast, Amir explained that the strategic selection of both an antibody-based technology (NanoAbs) and indications with validated antibody drug targets prevents the company from reinventing the wheel (https://ibn.fm/ulg3u). Certain antibodies are already known to generate a good clinical response whenever they are used to attack a target molecule. Thus, according to Reichman, Scinai Immunotherapeutics’ strategic approach is expected to shave off $200 million and seven years of drug development.

In addition to its ongoing R&D and to bolster recurring revenue, the company has rolled out boutique end-to-end Contract Development and Manufacturing Organization (“CDMO”) services under the banner Scinai Bioservices. Intended to serve biotech, pharmaceutical, and alternative protein food tech companies with pilot and clinical process development and manufacturing, the division will leverage SCNI’s cGMP manufacturing facility, state-of-the-art laboratories, and deep pharma experience.

“There is growing demand by small biotech companies seeking high quality, yet affordable CDMO services to accelerate their drug development processes, including cGMP aseptic processing required for manufacturing of clinical batches. Scinai’s state-of-the-art biologics facility and team’s capabilities and extensive experience are a perfect match for these clients,” said Reichman in a press release announcing the finalization of a major rebrand (https://ibn.fm/lsGuY).

The company’s management is optimistic about SCNI’s growth potential and ability to deliver value to its stakeholders. “We have a sharp commercial focus and a pipeline with blockbuster potential, steeped in science, strong leadership, and an expertly designed technological base,” concluded Reichman.

For more information, visit the company’s website at www.Scinai.com.

NOTE TO INVESTORS: The latest news and updates relating to SCNI are available in the company’s newsroom at https://ibn.fm/SCNI

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