Scinai Immunotherapeutics Ltd 6-K, filed Dec 29, 2022
Scinai Immunotherapeutics Ltd. (SCNI)
About this 6-K
Scinai Immunotherapeutics Ltd filed this 6-K on December 29, 2022.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16
Under the Securities Exchange Act of 1934
For the Month of December 2022
Commission File Number: 001-37353
BIONDVAX PHARMACEUTICALS LTD.
(Translation of registrant’s name into English)
Jerusalem BioPark, 2nd Floor
Hadassah Ein Kerem Campus
Jerusalem, Israel
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ____
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ____
BiondVax Pharmaceuticals Ltd. (the “Company”) has made available an updated presentation about its business, a copy of which is furnished herewith as Exhibit 99.1 and incorporated by reference. Slides 9-11 include additional information about the Company's preclinical in vivo study of its inhaled COVID-19 NanoAb therapy and slide 24 includes an updated select financial and cap table of the Company. The new updates in the Presentation are not an admission as to the materiality of any information therein. The information contained in the Presentation is summary information that should be considered in the context of the Company’s filings with the Securities and Exchange Commission and other public announcements the Company may make by press release or otherwise from time to time.
Exhibit Index
Exhibit No. |
Description | |
| 99.1 | BiondVax Presentation dated January, 2023 |
1
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| BiondVax Pharmaceuticals Ltd. | ||
| Date: December 29, 2022 | By: | /s/ Amir Reichman |
| Amir Reichman | ||
| Chief Executive Officer | ||
2
Exhibit 99.1
NASDAQ: BVXV | JANUARY 2023
2 This communication is not a prospectus or offer of securities for subscription or sale in any jurisdiction. This communication 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 communication 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, statements regarding the therapeutic and commercial potential of nanosized antibodies ( NanoAbs ) ; the pipeline market potential and the timing of NanoAb proof - of - concept studies and clinical trials . 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 BiondVax Pharmaceuticals Ltd . Risks and uncertainties include, but are not limited to, the risk that the therapeutic and commercial potential of NanoAbs will not be met ; the risk of changes in the pipeline market potential ; the risk of a delay in the preclinical and clinical data for NanoAbs , if any ; the risk that BiondVax may not be able to secure additional capital on attractive terms, if at all ; risks relating to the COVID - 19 (coronavirus) pandemic ; BiondVax’s ability to acquire rights to additional product opportunities ; BiondVax’s ability to enter into collaborations on terms acceptable to BiondVax or at all ; timing of receipt of regulatory approval of BiondVax’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 20 - F filed with the Securities and Exchange Commission on March 28 , 2022 . BiondVax undertakes no obligation to revise or update any forward - looking statement for any reason . SAFE HARBOR STATEMENT
3 Collaboration with Max Planck & UMG Top - tier pharma leadership GMP biologics manufacturing facility Extensive drug development expertise Uniquely positioned to advance nanosized antibody innovation from R&D through commercialization
4 THE SCIENCE OF NANOSIZED ANTIBODIES ( NANOAB ) * VHH - antibody is trademarked by ABLYNX N. V., a wholly owned subsidiary of Sanofi, as Nanobody. BiondVax has no affiliation with and is not endorsed by Sanofi. HUMAN ANTIBODY ALPACA - DERIVED NANOAB Alpaca - derived nanosized antibodies (NanoAbs) are also known as VHH - Antibodies *
5 N ANO A B VALUE PROPOSITION Multiple crucial advantages compared to monoclonal antibodies (mAbs) & oral therapies CLINICAL BENEFITS CONVENIENT & FLEXIBLE • Hyper - thermostability = longer shelf life, easier storage & distribution • Multiple, easier routes of administration • Faster antibody discovery, development and production • Superior specificity & binding affinity can increase efficacy • Adaptable half life • Lower immunogenicity • Fewer counter indications • Potentially safer & lower dose
6 DERISKED NANOAB PATHWAY MOLECULAR TARGET MECHANISM OF ACTION COMPOSITION OF MATTER COMMERCIAL ض ض + TBD Validated by existing but sub - optimal mAb therapies Well understood Assessing safety & efficacy of alpaca - derived NanoAbs Solid demand for available mAbs, and underserved populations NanoAbs feature a favorable path to market compared to risks associated with traditional drug development SOURCE OF RISK NANOAB VALIDATED THERAPEUTIC USE First commercial VHH - antibody is blood disorder therapy Caplacizuma – by Ablynx, acquired by Sanofi in 2018 for $4.8B
7 COLLABORATION WITH MAX PLANCK • World - class science & access to leading scientists • NanoAb platform for development of promising potent therapeutics • Patents covering NanoAbs & their manufacturing BIONDVAX MAX PLANCK & UMG 1 Designed to create significant clinical and commercial advantages 1 . Max Planck Institute of Multidisciplinary Sciences and the University Medical Center Göttingen (UMG) • Infectious disease & recombinant protein drug development experience: from lab to Phase 3 clinical trial • Manufacturing, quality, int’l regulatory experience • GMP NanoAb manufacturing facility • Top - tier big pharma & biotech leadership expertise Exclusive worldwide license for COVID - 19 asset + exclusive option to exclusively license additional NanoAbs developed through collaboration
8 COVID - 19 NANOAB CANDIDATE HAS A STRONG COMPETITIVE EDGE • Hyperthermostability to 95 ƒ C ( 200 ƒ F) • Direct targeting potential via convenient inhalation administration 1 . In - vitro data shows neutralization of all COVID variants of concern including Delta and Omicron | 2. EMBO J (2021) 40: e107985 https://doi.org/10.15252/embj.2021107985 . | PROF. DR. DIRK GÖRLICH • Director Max Planck Institute for BioPhysical Chemistry • >25K peer - reviewed citations PROF. DR. MATTHIAS DOBBELSTEIN • Fellow Max Planck Institute for BioPhysical Chemistry • UMG Head of Department Neutralization of SARS - CoV - 2 by highly potent, hyper - thermostable, & mutation - tolerant nanobodies (2) “ SCIENTIFIC COLLABORATORS AT MAX PLANCK & UMG & AUTHORS OF: • Max Planck & UMG scientists are leaders in designing and optimizing NanoAbs • Neutralizes Omicron variants that other mAbs do not • Result: > 100 x stronger neutralization of variants of concern at low concentrations vs leading mAb ( 1 )
9 85 90 95 100 0 1 2 3 4 5 6 Weight (%) Day INHALED ANTI - COVID - 19 NANOAB PROTECTED HAMSTERS FROM SEVERE DISEASE Significantly milder disease course measured by weight loss in hamsters infected with SARS - COV - 2 and then treated with inhaled anti - COVID - 19 NanoAbs compared to placebo Highly statistically significant difference ( p<0.001 ) Inhaled NanoAb group’s weight declined on average only 3.80% Placebo group ’ s weight declined on average 12.01 % Results reported November 29 , 2022 : https://www.biondvax.com/press - releases/biondvax - reports - successful - results - in - preclinical - in - vivo - study - of - its - innovative - inh aled - covid - 19 - nanoab - therapy Weight as a proxy for efficacy : According to the paper titled Hamsters as a Model of Severe Acute Respiratory Syndrome Coronavirus - 2 , hamsters are “an ideal animal model of SARS - CoV - 2 infections because they recapitulate many aspects of human infections.” The paper noted that weight loss in hamsters was redu ced when treated with REGN - COV - 2, a human mAb combination therapy that ultimately received FDA approval for SARS - CoV - 2 treatment. BiondVax has no affiliation with the authors or sponsors of the paper.
10 INHALED ANTI - COVID - 19 NANOAB RESULTED IN MILDER AND SHORTER ILLNESS BiondVax’s nanosized antibodies (NanoAbs) are being formulated as convenient self - administered inhaled COVID - 19 therapy The inhaled COVID - 19 therapy is BiondVax’s first in a new pipeline of innovative alpaca - derived NanoAb therapies addressing diseases with large underserved medical needs and attractive commercial opportunities such as psoriasis and asthma Results reported November 29, 2022: https://www.biondvax.com/press - releases/biondvax - reports - successful - results - in - preclinical - i n - vivo - study - of - its - innovative - inhaled - covid - 19 - nanoab - therapy Results of main parameter (weight loss) supported by scoring of eight other parameters , including heart rate and social behaviors. Milder illness and faster recovery of hamsters infected with SARS - COV - 2 then treated with inhaled anti - COVID - 19 NanoAbs compared to those treated with placebo Day Illness severity 0 1 2 3 4 5 6 0 1 2 3 - 1 NanoAb Placebo
11 Placebo 0 500 1000 1500 2000 2500 3000 3500 4000 4500 TCID50/ml NanoAb 2935.3 SE < 57* INHALED ANTI - COVID - 19 NANOAB E LIMINATED VIRAL LOAD IN THE LUNGS TCID50 * is a measure of viral titer (the amount of virus) in lung cells Over a week after infection, compared to placebo group, hamsters treated with BiondVax’s NanoAb had over 50 times lower SARS - COV - 2 viral titers in their lungs These results also confirmed by PCR Study conducted beginning Nov. 2022 on behalf of BiondVax by world renowned institutions The Fraunhofer Institute for Toxicology and Experimental Medicine (ITEM) and The University of Veterinary Medicine Hannover ( TiHo ) TCID50 (Tissue Culture Infective Dose that infected 50% of the cells) in NanoAb group was below the detectable level of 57
12 Initial waves Mar. 2020 Jan 2021 June Jan 2022 June Dec 23, 2022: 779K cases (3) TARGETING A MATURING MARKET FOR COVID - 19 THERAPY 1 . New England Journal of Medicine. https://www.nejm.org/doi/full/10.1056/NEJMp2118468 . | 2. WHO | 3. Some countries reportedly significantly under reporting “ SARS - CoV - 2 is unlikely to be eliminated, let alone eradicated; it will probably continue to circulate indefinitely in periodic outbreaks and endemics. -- ANTHONY FAUCI, December 2021 . ( 1 ) Delta variant Omicron variant Worldwide COVID - 19 Cases REPORTED WEEKLY AS OF DEC 23, 2022 (2) 20M cases 10M
13 € 2.6 B asthma € 10.4 B psoriasis €5.0B macular degeneration €4.5B psoriatic arthritis PIPELINE MARKET POTENTIAL INITIAL FOCUS 1. EvaluatePharma (via Zacks); 2. 2021, LEK; 3. Based on laboratory research at Max Planck Institute for Biophysical Chemistry (MPG) and University Medicine Göttingen (UMG), and data from BiondVax’s ongoing preclinical in vivo trial $2.2B COVID - 19 FUTURE DERISKED TARGETS CURRENT MARKET SIZES 2 2026 PROJECTED TREATMENT MARKET 1 Lead candidate demonstrating strong competitive edge 3 • Validated targets of existing mAb treatments • Short time to value generation, lower risk than mAbs • Large markets growing at attractive CAGRs
14 N ANO A B D EVELOPMENT M ILESTONES * Paul Ehrlich Institute (PEI) Scientific Advice Tech transfer: In - house production of COVID NanoAb COVID - 19 neutralization through inhaler Omicron neutralization demonstrated at Max Planck; NanoAb to be used in our first - in - human clinical trial European regulatory support for Phase 1 / 2 a safety & efficacy trial* Successful proof of concept (POC) COVID NanoAb in - vivo trial Complete COVID NanoAb POC trial with lower and prophylactic doses Large - scale and GMP production Toxicity studies Human clinical trial (Phase 1/2a) of inhaled COVID19 NanoAb Additional NanoAbs license & POC (e.g. IL - 17 psoriasis treatment) 2022 - ACHIEVED 2023
15 Uniquely positioned to advance nanosized antibody innovation from R&D through commercialization GMP biologics manufacturing facility Top - tier pharma leadership Collaboration with Max Planck & UMG Extensive drug development expertise
16 GMP MANUFACTURING AND R & D • Analytical methods development combined with best - in - class QC capabilities and equipment • Labs for manufacturing process development and scale up allow for implementation of quality by design and design of experiment principles • GMP suites for up stream fermentation, down stream purification, media and buffer preparations, formulation and aseptic automated filling of PFS & vials • Designed to meet FDA and EMA regulatory standards • Single - use equipment enables: • Adaptable manufacturing processes for a pipeline of different products • Quicker lead times • Faster time - to - market for new products Industry standard aseptic facility: Labs, clean rooms, warehouse, offices BiondVax’s 1850m 2 GMP Biologics Manufacturing Facility | Jerusalem
17 NANOAB PRODUCTION : HIGH YIELD , LOW COST , IN - HOUSE COVID NanoAb 10 15 20 25 30 40 50 60 70 85 100 kDa 0.5 µl Supernatant Yeast: Pichia pastoris Demonstrating efficient, extremely clean process in yeast Batch fermentation yields up to 9 g / litre, indicating kg yields in standard 1000 litre fermenter (WEIGHT)
18 CDMO SERVICES While NanoAb pipeline development is BiondVax’s core focus, we also offer CDMO services by leveraging our cGMP manufacturing facility, aseptic fermentation and fill and finish suites, R&D and QC laboratories and experienced professionals. Our CDMO services may support: • Pharmaceutical and biotech companies • Alternative protein food tech companies • Pilot, clinical and process development stages De - risking R&D investments by leveraging internal capabilities ASEPTIC GMP MANUFACTURING SUITES STATE - OF - THE - ART R & D AND QC LABORATORIES PHARMA CMC EXPERIENCE More info biondvax.com/ cdmo
19 Top - tier pharma leadership Collaboration with Max Planck & UMG GMP biologics manufacturing facility Extensive drug development expertise Uniquely positioned to advance nanosized antibody innovation from R&D through commercialization
20 EXPERIENCED LEADERSHIP COO Built manufacturing sites for recombinant protein in China and mABs for Novartis Singapore • Principal bioprocess engineer • Novartis (Technical Project Manager - Process) CSO Co - invented and guided BiondVax’s original vaccine candidate through 8 clinical trials including pivotal Phase CEO Pharmaceutical engineering & supply chain leadership at GSK Vaccines, Belgium; large projects building vaccine manufacturing sites in Belgium, Italy, Germany, Hungary & US. • NeuroDerm (R&D) • Novartis Vaccines (Global Supply Chain) • GSK Vaccines (Global Engineering) CFO Amir Reichman Tamar Ben - Yedidia Elad Mark VP Technical R&D Dalit Weinstein - Fischer Chief Of Staff Moran Ahdout Fruchter Uri Ben - Or Senior Manager QC Merav Kamensky Director IR & Communications Joshua Phillipson
21 Amir Reichman, MBA CEO NeuroDerm Ltd (Senior Scientist), Novartis Vaccines USA (R&D and Global Supply chain), GSK Vaccines Belgium (Global Supply Chain and Global Engineering) Morris C. Laster, MD Director BioLineRx (CEO, Director), OurCrowd (Partner), Clil Medical (CEO), Vital Spark (CEO), Kitov Pharmaceuticals (Co - founder, Director) George Lowell, MD Director ID Biomedical (CSO), Intellivax (Founder), Walter Reed General Hospital (Consultant) Yael Margolin, PhD External Director Gamida Cell Ltd. (Nasdaq: GMDA) (President, CEO, Director), Denali Ventures LLC (VP) Avner Rotman , PhD Director Biodar (CEO), Rodar (Founder) BOARD BRINGS SIGNIFICANT EXPERTISE Mark Germain Chairman Aentib Group (Managing Director). Founder, director, chairman, and/or investor in over 20 biotech companies Samuel Moed Director Bristol Myers Squibb (NYSE: BMY) (Senior Vice President, Corporate Strategy) Adi Raviv, MBA External Director Experienced in Wall Street investment banking; Capacity Funding LLC (Principal) Jay Green External Director Glaxo SmithKline (NYSE: GSK) Global Vaccines (Senior Vice President Finance and CFO), Gavi (Advisor for COVAX) North America based Israel based
22 Extensive drug development expertise Top - tier pharma leadership Collaboration with Max Planck & UMG GMP biologics manufacturing facility Uniquely positioned to advance nanosized antibody innovation from R&D through commercialization
23 IN - HOUSE EXPERIENCE & ASSETS Developed flu vaccine initiated in the Weizmann Institute of Science lab of Prof. Ruth Arnon Seven Phase 1 / 2 and 2 clinical trials conducted in Israel, Europe, and USA, each with promising results. US trial funded and conducted by NIH . GMP Manufacturing: Constructed, own and operate facility well - suited for development and production. Fundraising: Nasdaq listed, € 24m EIB loan, and long - term anchor investor BiondVax’s drug development, GMP manufacturing, and fundraising capabilities accelerate new programs Pivotal Phase 3 : Seven country, 12,400 participant trial conducted 2018 to 2020 completed on - time and on - budget. Clinical endpoints were not achieved.
24 SELECT FINANCIALS & CAP TABLE • $ 8.3 M cash as of Sept 30 , 2022 • $ 7.3 M net raised in Dec 2022 • $ 1 M avg monthly burn in 2022 • € 24 M European Investment Bank (EIB) loan payable in Dec 2027 in a bullet payment plus accrued interest • ~ 17 % of shares held by leading biotech investor CAP TABLE As of December 24, 2022 ADS OUTSTANDING % Ordinary ADS 2,470,577 36 Pre - funded ADS 1,080,000 16 Exchangeable Warrants (Expire 20 Dec 2023) 1,535,000 22 Warrants (Expire 22 Dec 2025) 1,600,000 23 Options + RSUs 167,406 2 Fully Diluted Shares Out 6,852,983 100% BVXV 24
25 SIGNIFICANT POTENTIAL FOR VALUE CREATION Creating pipeline of therapeutic drugs based on NanoAb platform Five - year research collaboration with Max Planck & UMG, world - leading research organizations, including exclusive option for exclusive license for additional NanoAbs De - risked R&D strategy by targeting massive, validated addressable markets underserved by current monoclonal antibody therapies such as psoriasis, asthma, psoriatic arthritis and macular degeneration Lead candidate, inhaled COVID - 19 therapeutic, has strong competitive edge Well - positioned to bring innovative therapies to market with unique competencies Key catalysts expected in 2023 BIONDVAX.COM | Contact: Joshua Phillipson, Investor Relations j.phillipson@biondvax.com + 972.8.930.2529