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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) announced that Joshua Phillipson, its Director of Investor Relations, will present at the LD Micro Main Event XV in Los Angeles from October 25 to 27, 2022. Phillipson's presentation on October 25 at 9am PT will highlight BiondVax's investment case, featuring its innovative nanosized antibody platform and key upcoming milestones. Investors can schedule one-on-one meetings with Phillipson during the conference. BiondVax focuses on products for infectious diseases and has completed eight clinical trials.

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BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) announced the filing of a Form F-1 with the SEC for a firm commitment underwritten offering of American Depositary Shares (ADSs). This capital raise aims to support the development of its COVID-19 NanoAb inhaled therapy and expand its pipeline, including treatments for psoriasis and asthma. However, BiondVax received a notification from Nasdaq regarding non-compliance with minimum stockholders' equity of $2,500,000, reporting only $1,277,000. The company has 45 days to submit a plan to regain compliance.

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BiondVax Pharmaceuticals (Nasdaq: BVXV) announced progress in its collaboration with the Max Planck Institute and University Medical Center Göttingen to develop innovative alpaca-derived nanosized antibody (NanoAb) therapies. The team has successfully generated NanoAbs targeting IL-17A, IL-17F, and IL-13 aimed at treating psoriasis, psoriatic arthritis, and asthma. A preclinical study for an inhaled COVID-19 NanoAb therapy is set to begin soon, with potential clinical trials in 2023. BiondVax's strategy aims to capitalize on validated antibody targets, showcasing significant commercial potential.

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BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) announced its CEO, Amir Reichman, will attend the H.C. Wainwright 24th Annual Global Investment Conference from September 12-14, 2022, in New York City. His pre-recorded presentation will also be available online. Investors can schedule one-on-one meetings with him and Chairman Mark Germain via the conference's scheduling platform. BiondVax specializes in developing innovative products for infectious diseases, having conducted eight clinical trials, including a Phase 3 trial involving 12,400 participants.

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BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV) reported financial results for Q2 2022, highlighting significant advances in its COVID-19 NanoAb program. R&D expenses surged to NIS 6.5 million ($1.85 million) from NIS 1.9 million YoY, reflecting ongoing drug development initiatives. The company plans to initiate a proof of concept study in September 2022. While the net loss increased to NIS 12.9 million ($3.7 million) from NIS 12.0 million YoY, cash reserves stood at NIS 39.5 million ($11.3 million), down from NIS 54.0 million at 2021 year-end.

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BiondVax Pharmaceuticals (Nasdaq: BVXV) announced the formal approval from the European Investment Bank (EIB) to restructure its €24 million loan. Key terms include extending maturity to December 2027, deferring interest payments until then, and implementing a repayment plan with an initial payment of $900,000. Additionally, BiondVax will pay 3% of revenues exceeding €5 million as royalties to the EIB. This development supports BiondVax's strategy to advance its nanosized antibody (NanoAb) pipeline with collaboration partners in Germany.

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BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) announced receiving supportive feedback from the Paul Ehrlich Institute (PEI) regarding its COVID-19 NanoAb therapy development. PEI's advice, a crucial step towards regulatory approval, endorses a combined Phase 1/2a clinical trial to assess safety and efficacy, significantly shortening the development timeline. BiondVax plans to commence this trial in 2023, following anticipated proof-of-concept studies. The NanoAb boasts advantages such as easy self-administration via inhalation and stability at higher temperatures.

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BiondVax Pharmaceuticals Ltd. (BVXV) released its first quarter financial results for 2022, reporting total operating expenses of NIS 8.3 million ($2.6 million), up from NIS 6.8 million in Q1 2021. R&D expenses rose to NIS 3.65 million ($1.1 million), primarily driven by advancements in the NanoAb program targeting COVID-19. The company also presented successful in-vitro neutralization results against COVID-19 and Omicron. As of March 31, 2022, BiondVax had cash and equivalents of NIS 48.9 million ($15.4 million), a decrease from NIS 54.0 million at the end of 2021.

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BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV) will present at the H.C. Wainwright Global Investment Conference on May 24, 2022, in Miami, Florida. The presentation, led by Chairman Mark Germain at 9:30 AM ET, will highlight their innovative nanosized antibodies (NanoAbs), developed with the Max Planck Institute and University Medical Center Göttingen, targeting significant medical needs like COVID-19, asthma, and macular degeneration. Investors interested in meeting Mr. Germain can contact investor relations.

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BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) reported significant advancements in its nanosized antibodies (NanoAbs) program at the Biomed conference in Tel Aviv. Highlights include successful technology transfer from the Max Planck Institute, enabling in-house production of a COVID-19 NanoAb with strong in-vitro neutralization capabilities. A new NanoAb targeting the Omicron variant has also shown effective neutralization in vitro. CEO Amir Reichman expressed optimism about leveraging these achievements for future NanoAb developments, positioning BiondVax strategically in addressing various unmet medical needs.

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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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