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BiondVax Pharmaceuticals Ltd. - BVXV STOCK NEWS

Welcome to our dedicated page for BiondVax Pharmaceuticals Ltd. news (Ticker: bvxv), a resource for investors and traders seeking the latest updates and insights on BiondVax Pharmaceuticals Ltd. stock.

BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) is a biopharmaceutical company pioneering innovative solutions in the realm of inflammation and immunology (I&I). With a robust pipeline of nanosized VHH antibodies known as NanoAbs, BiondVax is targeting diseases with significant unmet medical needs. The company has made notable strides, particularly with its leading product, an intradermal NanoAb targeting IL-17 for treating mild to moderate plaque psoriasis. This product has shown promising results in preclinical ex-vivo trials and is gearing up for human clinical trials in 2025.

BiondVax operates two main business units. The first focuses on the in-house development of biological therapeutic products, leveraging its NanoAb technology licensed from the Max Planck Society and the University Medical Center Göttingen, Germany. The second unit, Scinai Bioservices, is a boutique Contract Development and Manufacturing Organization (CDMO) that offers end-to-end services ranging from drug development to GMP manufacturing. Launched in Q3 2023, Scinai Bioservices has already secured contracts with several biotechnology companies and aims to support small biotech firms in bringing their products to market efficiently.

The company recently welcomed Liat Halpert as Head of Business Development and Sales. Halpert, with her extensive experience from Novartis, is expected to expand Scinai’s CDMO business, particularly targeting European and U.S.-based biotech companies. This strategic move is anticipated to significantly boost BiondVax's revenue and establish it as a key partner for small biotechnology firms.

In recent news, BiondVax announced successful preclinical results of its IL-17 targeting NanoAb for psoriasis treatment. Additionally, its NanoAbs for COVID-19 have shown efficacy in preclinical trials, demonstrating potential in preventing and treating viral respiratory diseases through inhalation, a convenient administration route.

BiondVax's financial stability and strategic partnerships position it well for future growth. The company continues to seek collaborative opportunities with mid and large-cap pharmaceutical companies to advance its NanoAb therapies through clinical trials and towards commercialization.

For the latest updates and detailed information, visit BiondVax’s official website at www.biondvax.com.

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BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) has announced a public offering priced to raise approximately $8 million before expenses. The offering includes 1,600,000 units, with each unit comprising one American Depositary Share (ADS) and two warrants. The company plans to utilize the proceeds for advancing its NanoAbs development program and general corporate purposes including R&D and working capital. The offering is set to close on December 20, 2022, contingent on standard closing conditions.

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BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) announced on December 12, 2022, that it has regained compliance with Nasdaq listing rules regarding minimum stockholders’ equity and minimum bid price. Following the receipt of non-compliance notifications earlier in 2022, Nasdaq confirmed that BiondVax now meets the required minimum stockholders’ equity of $2.5 million and that its stock price has remained above $1.00 per share for the past ten trading days. The company is focusing on developing immunotherapeutic products and has conducted multiple clinical trials.

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BiondVax Pharmaceuticals Ltd. has engaged IBN for corporate communications to bolster awareness of its innovative nanosized antibody (NanoAb) therapies targeting COVID-19, asthma, and psoriasis. Collaborating with the Max Planck Institute and University Medical Center Göttingen, BiondVax aims to leverage its unique technology advantages in production and delivery. The inhaled mechanism of the COVID-19 therapeutic NanoAb, set for a Phase 1/2a trial in 2023, may differentiate it from existing monoclonal antibodies. BiondVax is dedicated to developing a robust pipeline of immunotherapeutic products.

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BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) has appointed Professor Dr. med. Matthias Dobbelstein to its Scientific Advisory Board. With extensive experience in molecular oncology and virology, Dobbelstein's research includes the development of anti-cancer drugs as antivirals and innovative nanobody therapies. His collaboration with BiondVax has focused on a self-administered inhaled NanoAb for COVID-19 treatment, currently undergoing preclinical trials. Additionally, a five-year strategic research agreement aims to develop NanoAbs for autoimmune diseases. This appointment is expected to strengthen BiondVax’s innovative pipeline.

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BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) has reported Q3 2022 financial results, indicating a net profit of NIS 3.7 million ($1.05 million), a turnaround from a loss of NIS 9 million a year prior. R&D expenses rose to NIS 3.9 million ($1.1 million) due to new COVID-19 NanoAb program activities. The company is progressing in a collaboration with Max Planck Institute and University Medical Center Göttingen for NanoAb therapies. BiondVax is addressing compliance issues with Nasdaq regarding shareholders' equity and share bid price, restructuring a €24 million debt to regain compliance.

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BiondVax Pharmaceuticals (Nasdaq: BVXV) announced significant efficacy results from a preclinical study of its inhaled COVID-19 NanoAb therapy. The therapy demonstrated a reduction in weight loss in infected hamsters, showing only a 3.80% decline versus 12.01% in the control group (p<0.001). The company plans to initiate a first-in-human Phase 1/2a clinical trial in late 2023. This inhaled therapy aims to address COVID-19 and other diseases with high medical need, positioning BiondVax to capture market opportunities with its innovative NanoAb pipeline.

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BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) celebrates a significant achievement as Professor Dr. Dirk Görlich, a co-lead collaborator, wins the inaugural $1.4 million World Laureates Association Prize in Life Sciences for his work on protein transport. This accolade recognizes the collaboration with BiondVax in developing nanosized antibodies (NanoAbs) aimed at treating various diseases, including COVID-19. A preclinical study evaluating an inhaled NanoAb for COVID-19 therapy is currently underway, with results expected by year-end.

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BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) announced a change in the ratio of its American Depositary Shares (ADSs) from 1 ADS representing 40 ordinary shares to 1 ADS representing 400 ordinary shares, effective November 25, 2022. This change equates to a reverse split of 1 new ADS for every 10 old ADSs. The decision follows a notification from Nasdaq regarding non-compliance with the minimum bid price of $1.00 per share. The company anticipates that the ADS price may increase proportionally, though it cannot guarantee this outcome.

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BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) announced its participation in the Recent Advances in Fermentation Technology (RAFT) conference from November 6-9, 2022, in Orlando, Florida. Dr. Dalit Weinstein Fischer, Head of Technical R&D, will present on November 8 at 3:35 PM (ET), discussing a novel nano-sized solution for COVID-19, asthma, and psoriasis therapies. The focus is on their yeast fermentation system for producing alpaca-derived NanoAbs, which offer significant advantages over existing treatments.

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BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) announced it received two non-compliance letters from Nasdaq regarding minimum bid price and stockholders' equity. The first letter, dated October 27, 2022, indicated non-compliance with the $1.00 minimum bid price requirement, with a 180-day window to regain compliance. The second letter, from September 28, 2022, addressed the need for at least $2,500,000 in stockholders' equity. BiondVax has submitted plans to address these issues and is optimistic about future compliance and revenue generation through its innovative therapies.

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FAQ

What is the market cap of BiondVax Pharmaceuticals Ltd. (bvxv)?

The market cap of BiondVax Pharmaceuticals Ltd. (bvxv) is approximately 5.0M.

What does BiondVax Pharmaceuticals Ltd. do?

BiondVax Pharmaceuticals Ltd. is a biopharmaceutical company developing biological therapeutic products for inflammation and immunology (I&I) diseases and providing end-to-end CDMO services.

What are NanoAbs?

NanoAbs are nanosized VHH antibodies developed by BiondVax to target diseases with significant unmet medical needs, such as mild to moderate plaque psoriasis.

What recent achievements has BiondVax made?

BiondVax has shown successful preclinical results for its IL-17 targeting NanoAb for psoriasis and its COVID-19 NanoAbs. The company also launched Scinai Bioservices, a CDMO unit, in Q3 2023.

Who is Liat Halpert?

Liat Halpert is the newly appointed Head of Business Development and Sales at BiondVax, bringing extensive pharmaceutical sales and marketing experience from Novartis.

What services does Scinai Bioservices offer?

Scinai Bioservices offers end-to-end CDMO services, including drug development, analytical methods development, GMP manufacturing, and clinical trial design and execution.

When are human clinical trials for the psoriasis NanoAb expected?

BiondVax plans to enter human clinical trials for its IL-17 targeting NanoAb for psoriasis in 2025.

What are the potential applications of BiondVax's NanoAbs?

BiondVax's NanoAbs have potential applications in treating I&I diseases, including psoriasis and viral respiratory diseases like COVID-19.

How is BiondVax planning to expand its CDMO business?

BiondVax aims to expand its CDMO business by targeting European and U.S.-based biotech companies and establishing itself as a key partner for small biotechnology firms.

What regulatory approvals does BiondVax need?

BiondVax requires regulatory approval for its GMP manufacturing facility in Jerusalem and for its clinical trials to proceed.

Where can I find more information about BiondVax Pharmaceuticals Ltd.?

For more information, visit BiondVax’s official website at www.biondvax.com.

BiondVax Pharmaceuticals Ltd.

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