ADVFN Logo

We could not find any results for:
Make sure your spelling is correct or try broadening your search.

Trending Now

Toplists

It looks like you aren't logged in.
Click the button below to log in and view your recent history.

Hot Features

Registration Strip Icon for charts Register for streaming realtime charts, analysis tools, and prices.
BiondVax Pharmaceuticals Ltd

BiondVax Pharmaceuticals Ltd (BVXV)

1.36
0.00
(0.00%)
Closed March 28 04:00PM
0.00
0.00
(0.00%)

Get an advanced news scanner tailored to your needs by ADVFN

Enhance your trading experience

BVXV News

Official News Only

BVXV Discussion

View Posts
surf1944 surf1944 10 months ago
https://stockcharts.com/h-sc/ui?s=bvxv&p=D&yr=0&mn=6&dy=0&id=p38090673899

https://www.barchart.com/stocks/quotes/bvxv/technical-chart?plot=CANDLE&volume=total&data=DO&density=M&pricesOn=1&asPctChange=0&logscale=1&indicators=BBANDS(20,2);SMA(13);PTP(50);ADX(14);SMA(50);SMACD(12,26,9);RSI(14,100);ACCUM;STOSL(14,3)&sym=CNNA&grid=1&height=500&studyheight=100

https://www.barchart.com/stocks/quotes/bvxv/technical-chart?plot=CANDLE&volume=total&data=DO&density=ML&pricesOn=1&asPctChange=0&logscale=0&indicators=ACCUM;SMA(20);SMA(50);SMA(100);SMA(200);CHKMF(20)&sym=SYSX&grid=1&height=210&studyheight=100

https://www.barchart.com/stocks/quotes/bvxv/opinion

https://finance.yahoo.com/quote/BVXV/
๐Ÿ‘๏ธ0
subslover subslover 10 months ago
BiondVax signs exclusive license agreement for development and commercialization of a novel anti-IL-17 antibody for treatment of autoimmune and inflammatory diseases including psoriasis
Broad-based collaboration with Max Planck and University Medical Center Gottingen yields attractive anti-IL-17 VHH antibodies (NanoAbs); includes exclusive worldwide license for all potential indications, beginning with psoriasis.
BiondVax to lead development and commercialization of NanoAbs with potential to neutralize IL-17A, IL-17F and IL-17A/F isoforms with high potency; ex vivo proof-of-concept expected this year, in vivo early next year.
Psoriasis affects over 3% of U.S. population, with global biologics treatment market over $9B annually and growing with 7% CAGR.
Adds to BiondVaxโ€™s pipeline of bio-better antibodies targeting diseases with large unmet medical needs, attractive commercial opportunities, and that exhibit significant competitive advantages over existing therapies; recent preclinical in vivo data indicated that BiondVaxโ€™s anti-SARS-CoV-2 NanoAb virtually prevented illness when inhaled prophylactically and led to a significantly shorter and milder illness when inhaled therapeutically.
JERUSALEM, June 05, 2023 (GLOBE NEWSWIRE) -- via InvestorWire -- BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a biotechnology company focused on developing, manufacturing, and commercializing innovative immunotherapeutic products primarily for the treatment of infectious and autoimmune diseases, today announces that as part of its ongoing broad-based collaboration with the Max Planck Society and the University Medical Center Gottingen (UMG), it has signed an exclusive worldwide license agreement to develop and commercialize VHH antibodies (NanoAbs) targeting Interleukin-17 (IL-17) as treatments for all potential indications, starting with psoriasis and psoriatic arthritis.

โ€œThe license of the IL-17 NanoAb from Max Planck is not only an exciting opportunity to develop a unique treatment for psoriasis and other autoimmune diseases, but another validation of the productivity of our collaboration with Max Planck and UMG and portends additional significant developments to follow,โ€ said Mr. Amir Reichman, BiondVaxโ€™s CEO. โ€œPsoriasis affects millions of people worldwide, and we believe our NanoAbs have the potential to provide a much-needed and vastly improved treatment option.โ€

โ€œI wish to thank Professor Dirk Görlich of the Max Planck Institute for Multidisciplinary Sciences and Professor Matthias Dobbelstein of the University Medical Center Göttingen for their valued research collaboration, and Dr. Dieter Link of Max Planck Innovation and his team for their continued support. Our recent experience with tech-transfer, in-house process development, scale-up and manufacturing of the COVID NanoAb, leading to a highly successful preclinical study, attests to the strong potential of this unique collaboration to develop bio-better NanoAbs addressing underserved medical needs for millions of patients,โ€ Reichman continued.

โ€œWe are very pleased that the next VHH antibody candidates out of a larger group pursued by the collaborators have successfully been generated, discovered and characterized by the Max Planck Institute of Multidisciplinary Sciences. BiondVax is well positioned to move this closer to and into clinical application,โ€ commented Dr. Dieter Link, patent and licensing manager at Max Planck Innovation, the technology transfer organization of the Max Planck Society (MPG).

IL-17โ€™s Role in Disease

The IL-17 family of cytokines consists of six isoforms. Among these, IL-17A, IL-17F, and the IL-17A/F complex are particularly important in immune regulation and inflammation. Excess presence of IL-17 is implicated in a wide range of autoimmune and inflammatory diseases including psoriasis, and therefore is the molecular target for several commercially available therapeutics.

Psoriasis is a chronic autoimmune disease that causes inflammation and scaling of the skin. The National Psoriasis Foundation notes that the disease affects more than 7.5 million adults in the U.S. and an estimated 125 million people worldwide. The most common form of psoriasis, representing 80%-90% of cases, is plaque psoriasis. Current plaque psoriasis treatments include topical steroid creams, phototherapy, oral drugs and several injectable biologicals. According to industry sources, the current biologics treatment market for psoriasis is over $9 billion per year and the anti-17 antibody market is growing at 9% CAGR.

Of the biological treatments, monoclonal antibodies (mAbs) targeting IL-17A were the first mAbs to be approved for treatment of plaque psoriasis. The latest and most effective mAbs for the treatment of plaque psoriasis that are currently marketed, as well as those that, to BiondVaxโ€™s knowledge, are under clinical development by other companies, target not only IL-17A but also IL-17F and IL-17A/F complex. It has been demonstrated in clinical trials that targeting both IL-17A and IL-17F generates superior clinical efficacy in treatment of plaque psoriasis, as IL-17F is the most abundant IL-17 isoform in the psoriatic lesions. Currently available mAb therapies for psoriasis require inconvenient systemic injection every four to eight weeks, are approved only for treatment of moderate to severe plaque psoriasis (representing only 25% of plaque psoriasis patients) and are associated with adverse side effects including exacerbation of IBD.

Bio-Better NanoAbs

In contrast to mAb therapies, the single-monomer NanoAb licensed by BiondVax may be effective even at extremely low concentrations, against all three key isoforms of IL-17. This potential multi-target effect by a single NanoAb creates an opportunity for a significantly more effective therapeutic, at lower doses and with fewer side effects, for a broader range of disease conditions in addition to plaque psoriasis such as psoriatic arthritis and hidradenitis suppurativa. BiondVaxโ€™s NanoAbs, which are approximately one tenth the size of a standard mAb, are expected to have better tissue penetration thanks to their small size, and in lab experiments have demonstrated superior thermostability, which could translate to superior shelf life, easier transportation, and more convenient routes of administration.

Development Pathway

Under the BiondVax-MPG-UMG research collaboration agreement, NanoAb candidates must satisfy rigorous criteria relating to binding affinity, neutralization of the target and other attributes prior to being in-licensed by BiondVax. An ex vivo proof-of-concept for psoriasis using the anti-IL-17 NanoAb in a psoriatic human skin model is expected later this year. BiondVax plans to initiate a preclinical in vivo efficacy study in 2024 followed later by human clinical trials.

As an initial target indication, BiondVax plans to test the antibody in humans with local, intradermal injections directly to psoriatic lesions to test the NanoAbโ€™s ability to provide a safe and affordable biologic treatment for mild to moderate psoriatic patients for whom the available mAbs are not authorized, and who represent 85% of plaque psoriasis cases. BiondVax is working on plans to develop the drug also as a subcutaneous injection for systemic treatment targeting patients with moderate to severe plaque psoriasis.

Innovative NanoAb Platform and Collaboration

BiondVaxโ€™s NanoAb platform targets treatments of diseases with large unmet medical needs and attractive commercial opportunities, such as COVID-19, psoriasis, psoriatic arthritis, asthma and macular degeneration. NanoAbs exhibit several advantages over conventional antibody treatments, including improved stability, increased potency and the potential for safer and more convenient routes of administration.

The NanoAbs are being developed as part of a broad collaboration with the world-leading research institutes Max Planck Institute of Multidisciplinary Sciences and the University Medical Center Göttingen. Recent positive preclinical in vivo data indicates BiondVaxโ€™s innovative inhaled anti-SARS-CoV-2 NanoAb virtually prevented COVID-19 illness when administered prophylactically to hamsters. The results also demonstrated that when administered therapeutically, the inhaled NanoAb virtually eliminated the virus in lungs and led to a significantly shorter and milder illness. BiondVaxโ€™s NanoAb platform has the potential to address a wide range of unmet medical needs, and the company is committed to developing innovative therapies that improve the lives of patients.

---

About BiondVax

BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) is a biotechnology company focused on developing, manufacturing, and commercializing innovative immunotherapeutic products primarily for the treatment of infectious and autoimmune diseases. Since its inception, the company has executed eight clinical trials including a seven-country, 12,400-participant Phase 3 trial of its vaccine candidate and has built a state-of-the-art manufacturing facility for biopharmaceutical products. With highly experienced pharmaceutical industry leadership, BiondVax is aiming to develop a pipeline of diversified and commercially viable products and platforms beginning with an innovative nanosized antibody (NanoAb) pipeline. www.biondvax.com.

About the Max Planck Institute for Multidisciplinary Sciences

The Max Planck Institute (MPI) for Multidisciplinary Sciences was founded on 1 January 2022 through the merger of two existing Göttingen institutes, the MPI for Biophysical Chemistry and the MPI for Experimental Medicine. The two locations of the institutes remained City Campus and Faßberg Campus. At the Institute, we explore scientific issues ranging from physics and chemistry to structural and cell biology, neuroscience and biomedical research. Basic research in the natural sciences can thus be linked even more effectively with medical research approaches. We are guided by the conviction that great scientific discoveries can be achieved when scientists from different disciplines and research cultures - such as physics, chemistry and biology - work together and exchange ideas in an unbiased way. https://www.mpinat.mpg.de/en.

About University Medical Center Göttingen

The University Medical Center Göttingen (UMG) is one of Germanyโ€™s leading medical centers. With funding allocated by the state of Lower Saxony and third-party funding, UMG conducts research at the very highest level and are one of the largest medical faculties in Germany, based on the number of students enrolled. The Medical Faculty is as old as the University itself, founded in 1737. The UM
๐Ÿ‘๏ธ0
DPS1212 DPS1212 1 year ago
Somethingโ€™s coming up from the meeting yesterday imo. Watch!
๐Ÿ‘๏ธ0
reena969 reena969 1 year ago
So did I.... $2.55 seem to be the bottom. I'm looking forward to a PR about yesterdays event. Hopefully those hamsters are the real ones that was injected and not replacements for the dead ones...lol.
๐Ÿ‘๏ธ0
DPS1212 DPS1212 1 year ago
Added. No brainer.
๐Ÿ‘๏ธ0
SmellMyFinger SmellMyFinger 1 year ago
Yep, here we are. Let's see what happens.
๐Ÿ‘๏ธ0
SmellMyFinger SmellMyFinger 1 year ago
Same here. Lots of potential with recent news.
๐Ÿ‘๏ธ0
SmellMyFinger SmellMyFinger 1 year ago
Exactly. Testing on humans prior would be unethical.
๐Ÿ‘๏ธ0
SmellMyFinger SmellMyFinger 1 year ago
Unarguably true. Usually starts with animals, though.
๐Ÿ‘๏ธ0
SirCharge SirCharge 1 year ago
Thatโ€™s the point. You start out with hamsters then move to people. The CEO will be presenting these results at the San Francisco JP Morgan Biotech conference tomorrow.

https://finance.yahoo.com/news/biondvax-present-biotech-showcase-2023-120000220.html

โ€œThe presentation will focus on recent successful preclinical in vivo trial results of BiondVaxโ€™s inhaled COVID-19 therapy, and additional pipeline plans including a nanosized VHH-antibody (NanoAb) targeting IL-17 for the treatment of autoimmune diseases such as psoriasis and additional NanoAbs for the treatment of additional autoimmune diseases such as asthma, psoriatic arthritis and macular degeneration.โ€

They just about wiped out COVID in hamsters. Iโ€™d think something like that would be interesting for potential investors.

If that isnโ€™t enough BVXV just received a $57 per share valuation from Zackโ€™s small cap research. Thatโ€™s almost 20x its current SP.
๐Ÿ‘๏ธ0
ANTI-BAGHOLDER ANTI-BAGHOLDER 1 year ago
Interesting news, but need to see more then just from Hamsters
๐Ÿ‘๏ธ0
DH112 DH112 1 year ago
2023 here we go
๐Ÿ‘๏ธ0
midastouch017 midastouch017 1 year ago
BiondVax CEO Issues Letter to Shareholders

Published: Dec. 30, 2022 at 7:30 a.m. ET

The MarketWatch News Department was not involved in the creation of this content.

JERUSALEM, Dec 30, 2022 (GLOBE NEWSWIRE via COMTEX) -- JERUSALEM, Dec. 30, 2022 (GLOBE NEWSWIRE) -- via InvestorWire - BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a biotechnology company focused on developing, manufacturing and commercializing innovative immunotherapeutic products for the treatment of infectious and autoimmune diseases, today published a letter from its CEO, Amir Reichman, addressing 2022 accomplishments, successful preclinical trial results of the inhaled COVID-19 NanoAb therapy as well as recent financing activities to support 2023 objectives. The letter reads as follows:

Dear BiondVax Shareholders,

BiondVax's 2022 achievements leave me incredibly optimistic about BiondVax's growth potential and ability to deliver value to our stakeholders.

My optimism is based on our people, our partnerships and BiondVax's remarkable turnaround. When I became CEO in 2021, I inherited a company with strong leadership, extensive pharmaceutical development experience, and a new state-of-the-art biologics manufacturing facility but lacking a technology base to develop meaningful pharmaceutical products. After an extensive search in collaboration with industry expert consultants, we identified an opportunity to partner with the Max Planck Institute for Multidisciplinary Sciences (MPI) and the University Medical Center Gottingen, Germany (UMG) for development of new VHH nanosized antibodies (NanoAbs). In late 2021 and early 2022 we signed exclusive agreements with MPI and UMG to build a pipeline of "biobetter" NanoAbs, which are NanoAbs that interact with previously validated therapeutic targets and have strong potential for significant advantages over currently approved human monoclonal antibodies (mAbs).

As compared to mAbs, NanoAbs being generated at MPI demonstrate several unique attributes such as greater binding affinity, stability at high temperatures, and formulation advantages. We believe that if NanoAbs with these attributes can be successfully developed they would provide an opportunity to capture a meaningful share of several large and growing markets while reducing upfront costs and risks commonly associated with new drug development (e.g., biological target validation) and accelerating initiation of clinical development. In addition, having access to a pipeline would diversify our risk of failure from any one product candidate and provide greater opportunity and flexibility in pursuing partnering deals with big pharma companies.

NOW PLAYING:
Top Tech Plays



Visit our Video Center
With this foundation established, we began building a successful biopharmaceutical company and in 2022 achieved a number of exciting and meaningful milestones:

Q1 2022:

We completed signing a series of collaboration agreements with MPI and UMG for development of NanoAbs addressing diseases with large unmet medical needs and attractive commercial opportunities such as asthma, psoriasis, psoriatic arthritis, and macular degeneration, in addition to the COVID-19 program signed in Q4 2021.
Q2 2022:

We successfully executed tech transfer from Max Planck and began in-house manufacturing of the lead NanoAb candidate, an inhaled COVID-19 therapy, and received supportive scientific advice from the Paul Ehrlich Institute (PEI) to conduct the first clinical trials in patients as a combined Phase 1/2a, testing both safety and efficacy, thereby shortening BiondVax's clinical development timelines.
Q3 2022:

We further strengthened our financial position by signing a definitive amendment to our loan agreement with the European Investment Bank (EIB) extending maturity of our EUR24 million loan until Dec. 31, 2027, with additional terms in support of our new strategy.
We initiated discussions with potential clients interested in hiring us as their contract development and manufacturing organization (CDMO). While serving in this capacity is not intended to become a primary activity for the company, it allows us to use our state-of-the-art facility to generate revenues and offset certain fixed costs while still using it for our NanoAbs.
Q4 2022:

We reported the successful first readout results in the preclinical in vivo study of our innovative inhaled COVID-19 NanoAb therapy. Hamsters infected with SARS-COV-2 and then treated with inhaled anti-COVID-19 NanoAbs demonstrated significantly milder illness and faster recovery in comparison to infected hamsters treated with inhaled placebo.
Today, I am thrilled to share even more compelling results from the preclinical trial. New data from the same study shows that the inhaled NanoAb eliminated viral loads in the lungs:

Hamsters treated with BiondVax's NanoAb had over 30 times lower SARS-COV-2 viral titers in their lungs, six days after infection compared to the placebo group.

Experts continue to believe COVID-19 will remain a serious health risk in the coming years and as the uptake of vaccines wanes, therapeutics will become an important defense against severe illness. As reported by Pfizer, Paxlovid has shown the demand for COVID-19 therapeutic treatments with ~$22 billion in sales projected for 2022 despite significant limitations of use due to adverse cross-reactions with other drugs and several other comorbidity contraindications that limit its use.

Furthermore, previously approved mAb therapies have shown limited effectiveness against the new Omicron variants. Encouragingly, our lead NanoAb candidate, currently being prepared for clinical trials, has demonstrated neutralization of all relevant Omicron subvariants.

Indeed, the emergence of new variants remains a concern and NanoAb therapeutics have the potential to quickly and effectively address new variants. Our collaborators at MPI and UMG have generated libraries each with ~300 million COVID-19 NanoAb candidates, as compared to mAb libraries that contain only thousands of options. Thus, as new variants emerge, we would expect to be in a position to rapidly develop a new neutralizing NanoAb. If we are able to replicate in human trials the efficacy demonstrated to date in our hamster studies, we believe the flexibility inherent in our massive libraries, combined with the ease of self-administered inhalation, high thermo-stability (which implies longer shelf life and simpler shipping and storage), and low cost of goods, position us to capture a significant share of the COVID-19 therapeutics market.

Looking forward to 2023:

The collaboration with MPI and UMG has been more successful than we originally contemplated with a number of new potential NanoAb candidates for indications beyond COVID-19 identified well ahead of schedule, in particular, anti-IL-17 NanoAbs for the treatment of psoriasis as well as other disorders.

The highly favorable results from our COVID-19 hamster study and the identification of the IL-17 NanoAbs furthered our confidence to move both programs forward aggressively. Rather than slow down progress, in Q4 we determined to raise the capital to fast-track these programs. This was a difficult decision given overall market conditions. After careful consideration and with no certainty that market conditions would soon improve and realizing that delaying financing would impede progress and heighten the risk that funding would be increasingly difficult to obtain, we concluded that now presented the best opportunity to secure capital.

With funding in place to continue development, our plans include executing several steps required to bring our inhaled COVID-19 NanoAb therapy into a first-in-human Phase 1/2a clinical trial by the end of 2023. These steps include toxicology studies and GMP manufacturing of the NanoAb. We also intend to exercise our option to obtain an exclusive license at pre-agreed financial terms to anti-IL-17 NanoAbs from our partners in Germany, scale up in-house NanoAb manufacturing, conduct an in vitro proof-of-concept study and potentially also a preclinical trial of the IL-17 NanoAb as a therapy for psoriasis.

Bringing innovative pharmaceutical products through manufacturing, clinical trials and regulatory approvals requires substantial resources and entail a high degree of risk. Our biobetter NanoAb approach is specifically designed to mitigate the cost and risk ordinarily incurred in drug development, and we aim to aggressively pursue partnerships with big pharma that can bring in upfront and milestone payments, royalties, and funding for development activities, thereby further reducing our own funding needs and risk. A NanoAb pipeline may provide us with multiple partnering opportunities as well as flexibility in structuring relationships so as to preserve our upside. We also intend to pursue sources of non-dilutive funding, including grants from NGOs and from Israeli and European governmental organizations and have several grant applications in process. Securing meaningful partnerships with large pharma companies requires generating compelling data from pre-clinical and early clinical trials, which is exactly what we intend to pursue with the funds recently raised and with any grant money we are able to secure in the near future.

I believe we have set the stage in 2022 for a highly successful 2023. The BiondVax team, in collaboration with our scientific partners from MPI and UMG, has worked exceedingly hard to develop the company into a global leader in NanoAb technology and I truly appreciate their dedication, creativity and tireless efforts. I also want to thank our shareholders for their continued support as we progress toward our objectives. I'm grateful for the opportunity to lead BiondVax during this exciting period and pledge my utmost to build the company into a financial success by providing caregivers and patients high quality, innovative, de-risked, pharmaceutical products that help protect and improve human life.

Sincerely,

Amir Reichman, CEO
๐Ÿ‘๏ธ0
Benwahsauce Benwahsauce 2 years ago
Watching
๐Ÿ‘๏ธ0
beambe beambe 2 years ago
if you read the NEWS and can really understand them, you will invest
๐Ÿ‘๏ธ0
midastouch017 midastouch017 2 years ago
BiondVax Announces Fourth Quarter and Full Year 2021 Financial Results and Provides Business Update

https://finance.yahoo.com/news/biondvax-announces-fourth-quarter-full-110000518.html

JERUSALEM, March 28, 2022 /PRNewswire/ -- BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV), a biopharmaceutical company focused on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses, today published its fourth quarter and full year financial results for the year ended December 31, 2021 and provided a business update. At the same time, the Company filed its Annual Report on Form 20-F with the Securities and Exchange Commission.

Business Update

BiondVax signed an exclusive license agreement for the development and commercialization of a COVIDโ€“19 innovative nanosized antibody (NanoAbs) therapy in December 2021 with the Max Planck Institute for Multidisciplinary Sciences (MPG) and University Medical Center Göttingen (UMG), Germany.

BiondVax signed an additional definitive collaboration agreement in March 2022 with MPG and UMG for development of a pipeline of NanoAb therapies addressing diseases with large unmet medical needs and attractive commercial opportunities such as asthma, psoriasis, psoriatic arthritis, and macular degeneration; BiondVax has the option for an exclusive worldwide license for further development and commercialization of each of these NanoAbs.

In-house manufacturing: BiondVax has initiated preparations for the manufacturing of NanoAbs at the Company's GMP biologics manufacturing facility in Jerusalem, including acquiring and installing additional equipment and hiring talent highly experienced in the field. Owning a biological GMP manufacturing site provides BiondVax with a competitive edge compared to other development stage biotechnology companies as it reduces its dependency on contract manufacturers, allows direct control over manufacturing of the entire NanoAb pipeline during development and enhances preparedness for seamless clinical supplies and future commercial launch. It also provides the opportunity to create additional intellectual property.

The European Investment Bank (EIB) has indicated that it supports BiondVax's strategic turnaround plans. In March 2022, the EIB agreed in principle to extend the maturity of its loan until December 2027 with additional terms that provide continued long-term support for BiondVax.

Jay Green, former Senior Vice President Finance and CFO of GlaxoSmithKline plc (NYSE: GSK) global vaccines business, joined BiondVax's Board of Directors in December 2021.

Amir Reichman, BiondVax's CEO, stated, "I am very happy with our recent strategic developments which launch a new era for BiondVax. These achievements are very much in line with our strategy to build a broad product pipeline which strongly leverages BiondVax's research and clinical development expertise and in-house manufacturing capabilities. We are excited to work with our collaborators at Max Planck and UMG, both considered world class scientific institutions, as we progress the entire NanoAb opportunity."

Mr. Reichman continued, "Our initial goal is to demonstrate proof of concept of inhaled NanoAb therapy in animals in 2022 and conduct human clinical trials in 2023. In parallel, we will begin to generate NanoAbs for the additional indications covered by the new research collaboration agreement, creating a robust pipeline for the Company with multiple opportunities for strategic partnering."

Full Year 2021 Financial Summary

As BiondVax is based in Israel, results are recorded in New Israel Shekels (NIS) and a convenience translation to $US is provided using the exchange rate of 3.11 (NIS/$US), the rate as of the close of business on December 31, 2021.

Total operating expenses for 2021 were NIS 34.8 million ($11.2 million), compared with NIS 68.8 million in 2020, which were offset by other income of NIS 75.4 million due to the revaluation of the EIB loan.

R&D expenses for 2021 amounted to NIS 10.3 million ($3.3 million) compared with NIS 51.4 million in 2020.

Marketing, general and administrative expenses for 2021 were NIS 24.5 million ($7.8 million) compared with NIS 16.7 million in 2020.

Fourth Quarter 2021 Financial Summary

Total operating expenses for the three months ended December 31, 2021 were NIS 10.9 million ($3.5 million) compared with NIS 12.1 million for the three months ended December 31, 2020.

R&D expenses for the three months ended December 31, 2021 decreased to NIS 3.6 million ($1.15 million) from NIS 7.8 million for the three months ended December 31, 2020. This decrease was primarily attributable to expenses related to a Phase 3 clinical trial and related operations at our biologics manufacturing facility that was completed during Q4 2020.

Marketing, general and administrative expenses for the three months ended December 31, 2021 increased to NIS 7.3 million ($2.3 million) from NIS 4.2 million for the three months ended December 31, 2020. This increase was primarily due to an increase in compensation, consulting and legal services, and other related expenses, in support of changes in corporate strategy and management during 2021.

As of December 31, 2021, BiondVax had cash and cash equivalents of NIS 54 million ($17.4 million) as compared to NIS 9.4 million as of December 31, 2020. The increase in cash was primarily due to secondary offerings of shares in February and December 2021, which resulted in gross proceeds of $13.8 million and $9.8 million, respectively.

The complete audited financial results are available in the Company's Annual Report on Form 20-F for the year ended December 31, 2021, filed with the Securities and Exchange Commission. A summary is included in the tables below.
๐Ÿ‘๏ธ0
beambe beambe 2 years ago
good NEWS
๐Ÿ‘๏ธ0
beambe beambe 2 years ago
probably only a few really understood the news
๐Ÿ‘๏ธ0
beambe beambe 2 years ago
Volume: 54,275,504 @03/24/22 12:52:43 PM ED
๐Ÿ‘๏ธ0
beambe beambe 2 years ago
an exclusive worldwide license for BVXV worldwide is gigantic - just let that slowly melt in your mouth
๐Ÿ‘๏ธ0
MouthBreather MouthBreather 2 years ago
wtf is going on?
๐Ÿ‘๏ธ0
INEEDMONEY INEEDMONEY 2 years ago
What a bleed we r experiencing !
๐Ÿ‘๏ธ0
beambe beambe 2 years ago
good Volume
๐Ÿ‘๏ธ0
midastouch017 midastouch017 2 years ago
BiondVax signs definitive collaboration agreement for the development of a pipeline of innovative nanosized antibody (NanoAb) therapies

https://finance.yahoo.com/news/biondvax-signs-definitive-collaboration-agreement-110500067.html

JERUSALEM, March 24, 2022 /PRNewswire/ -- BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a biopharmaceutical company focused on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses, today announced the signing of definitive agreements with 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, to enter into a strategic collaboration for the development of innovative nanosized antibodies (NanoAbs). BiondVax will have an exclusive option for an exclusive worldwide license at pre-agreed commercial terms for further development and commercialization of each generated NanoAb.

BiondVax Pharmaceuticals Ltd. Logo
The NanoAbs previously developed by BiondVax's collaborators exhibit several valuable competitive advantages over existing therapies including uniquely strong binding affinity, stability at high temperatures, and potential for more effective and convenient routes of administration. The collaboration targets indications with large and growing market sizes where the NanoAb advantages have the potential to capture significant market share such as psoriasis, asthma, macular degeneration, and psoriatic arthritis. As with the parallel and previously announced exclusive license agreement for development of an inhaled COVID-19 therapeutic NanoAb, these are all diseases with known and validated antibody drug targets, which should shorten development timelines while increasing probability for drug approval.

BiondVax is planning a rapid development path that leverages the company's expertise and capabilities in biological drug development and manufacturing. In particular, NanoAbs can be mass-produced through recombinant protein manufacturing in sites such as BiondVax's GMP biologics manufacturing facility in Jerusalem. Development of NanoAbs covered under today's agreement has already begun, and initial preclinical results are expected in 2023. BiondVax anticipates conducting a preclinical proof of concept study of inhaled COVID-19 NanoAbs in 2022 with initial human clinical trials results in 2023.

Mr. Amir Reichman, BiondVax's CEO, commented, "The NanoAb platform is an incredible opportunity for BiondVax. It will serve as a basis for an exciting new pipeline of commercially attractive products to address large and growing markets significantly underserved by existing biological treatments. We are going after targets already validated, but with a proprietary NanoAb that we expect will have meaningful advantages in efficacy, cost and ease of use and treatment; a true 'biobetter' capable of capturing significant market share and expanding the market. The technology is also a great fit to our manufacturing site in Jerusalem and our experience and expertise in biological drug development. I would like to thank Professors Görlich and Dobbelstein for their enthusiasm for this project, and Max Planck Innovation's technology transfer team including Dr. Dieter Link and Florian Beilhack for their assistance in developing this innovative collaboration."

The NanoAb platform underlying this agreement was developed by the teams of Professor Dirk Görlich, Director at the MPI, with supporting bioassay development by Professor Matthias Dobbelstein, Professor of Molecular Oncology at the UMG. Professor Görlich commented, "We believe that the innovative platform developed at the Max Planck Institute for Multidisciplinary Sciences and the University Medical Center of Göttingen has great potential to provide patients with superior therapies. We are particularly pleased to team with BiondVax to use their drug development and manufacturing capabilities and expertise to advance the nanosized antibodies through additional development towards marketing approvals."

Prof. Dr. Martin Stratmann, President of the Max Planck Society, stated, "I am pleased that with BiondVax we have succeeded not only in finding a licensee but also a cooperation partner for the promising technology of nano-antibodies. Dirk Görlich and his team at the Max Planck Institute for Multidisciplinary Sciences, together with the University Medical Center Göttingen, have developed an innovative therapeutic approach within less than two years, which could also be used against COVID-19, among other things. Additional targets in other clinical settings are now pursued under a broader collaboration agreement. In this respect, we all hope that BiondVax will succeed in bringing these approaches to market."

The initial NanoAb blueprints are extracted from small blood samples of immunized alpacas, then selected and optimized in laboratories before being used for NanoAb production in large fermenters. The NanoAbs exhibit potential to serve as highly attractive therapies for diseases including COVID-19, as described in Görlich and Dobbelstein's paper titled "Neutralization of SARS-CoV-2 by highly potent, hyperthermostable, and mutation-tolerant nanobodies," published in The EMBO Journal and available at https://doi.org/10.15252/embj.2021107985. NanoAbs are also known as VHH-antibodies or nanobodies. Nanobody is a trademark registered by ABLYNX N.V., a wholly owned subsidiary of Sanofi. BiondVax has no affiliation with and is not endorsed by Sanofi.

The collaboration has been facilitated by kENUP, a civic society organization promoting innovative industries in Europe.
๐Ÿ‘๏ธ0
midastouch017 midastouch017 2 years ago
BiondVax to Present at Edison Group's Open House Conference
January 26 2022 - 07:39AM

https://finance.yahoo.com/news/biondvax-present-edison-groups-open-123900477.html

JERUSALEM, Jan. 26, 2022 /PRNewswire/ -- BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a biopharmaceutical company focused on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses, today announced that it is presenting at the Edison Open House: Global Healthcare 2022 conference.

BiondVax's presentation is currently available on-demand via the conference portal at https://www.edisongroup.com/edison-open-house-global-healthcare-2022.

BiondVax's management will also be meeting with investors in a virtual 1-1 setting in relation to this conference. If you wish to set up a meeting with management, please do so via the conference portal or speak directly with investor relations at BiondVax.
๐Ÿ‘๏ธ0
Man6677 Man6677 2 years ago
https://finance.yahoo.com/news/aegis-capital-corp-acted-sole-151500692.html

BVXS $$$
๐Ÿ‘๏ธ0
Man6677 Man6677 2 years ago
Hope for some more excellent updates here !
๐Ÿ‘๏ธ0
Man6677 Man6677 2 years ago
Thank you very much

๐Ÿ‘๏ธ0
midastouch017 midastouch017 2 years ago
This was the real good news:

#msg-167218822
๐Ÿ‘๏ธ0
Man6677 Man6677 2 years ago
Very nice news

Thank you !
๐Ÿ‘๏ธ0
midastouch017 midastouch017 2 years ago
BiondVax Announces Successful Closing of $9.8 million Follow-on Underwritten Offering of ADSs Including Exercise of the Over-Allotment

JERUSALEM, Dec. 29, 2021 /PRNewswire via COMTEX/ -- JERUSALEM, Dec. 29, 2021 /PRNewswire/ -- BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV), a biopharmaceutical company focused on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses, today announced the closing of an underwritten public offering of 4,144,068 American Depositary Shares ("ADSs") at a public offering price of $2.36 per ADS for gross proceeds to the Company of approximately $9.8 million in the aggregate, inclusive of the successful execution of the full over-allotment, before deducting underwriting discounts and other offering expenses. Each ADS represents 40 ordinary shares of BiondVax.

Amir Reichman, CEO of BiondVax, commented, "This successful offering is an important event for BiondVax as it provides us with increased capital to fund our recently announced nanosized antibody (NanoAb) program being conducted in collaboration with the world-renowned Max Planck Institute. Development of an innovative COVID-19 NanoAb therapy that exhibits significant potential competitive advantages over existing therapies has already begun, and next month we expect to sign a broader collaboration for the development of additional NanoAbs addressing diseases with large unmet medical needs and attractive commercial opportunities. I would like to thank all those who have supported our recent successes and I warmly welcome the new investors to our story."

BiondVax intends to use the net proceeds from this offering for the advancement of its recently announced nanosized antibody (NanoAb) development program as well as for general corporate purposes, including, but not limited to, working capital, research and development activities, regulatory matters, capital investment or other related purposes. It may also use a portion of any net proceeds to in-license, invest in or acquire businesses, assets or technologies that it believes are complementary to its business focus, although it has no current commitments or agreements in those regards.

Aegis Capital Corp. acted as the sole book-running manager for the offering.
๐Ÿ‘๏ธ0
midastouch017 midastouch017 2 years ago
Former CFO of GSK's Global Vaccines Business Mr. Jay Green Joins BiondVax's Board of Directors

https://finance.yahoo.com/news/former-cfo-gsks-global-vaccines-210100844.html

JERUSALEM, Dec. 27, 2021 /PRNewswire/ -- BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a biopharmaceutical company focused on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses, today announced that all proposed resolutions were approved at today's Annual General Meeting of Shareholders, including the election of Mr. Jay Green to the Company's Board of Directors. Mr. Green recently completed a six-year term as Senior Vice President Finance and CFO of GlaxoSmithKline plc's (NYSE: GSK) global vaccines business. Concurrently, Mr. Isaac Devash retired from the Board of Directors.

Mark Germain, BiondVax's Chairman of the Board of Directors, stated, "We're very excited to have Jay join our board of directors, particularly as we relaunch the company's R&D efforts around the unique nanosized antibody (NanoAb) program in collaboration with the Max Planck Institute. Jay's experience serving as GSK Vaccine's SVP Finance/CFO and his current involvement in the global COVIDโ€“19 response as an advisor to Gavi for COVAX is highly relevant and adds a significant dimension to our Board. We aim to leverage his broad knowledge and deep connections as we progress in developing our NanoAbs program, beginning with a highly promising COVID-19 therapy."

Continued Mr. Germain, "On a personal note, I wish to thank Isaac Devash for his many years of valued service to BiondVax. Isaac has been a dedicated leader on the board and instrumental and highly supportive in our efforts to relaunch the company. He remains a friend to the company and through our successful turnaround we intend to make him proud of the time and effort he has devoted."

Jay Green commented, "I am pleased to join BiondVax as we begin work on the nanosized antibody (NanoAb) pipeline towards new and improved therapies for multiple diseases with substantial commercial potential. BiondVax is a company with significant opportunity, at a new and exciting inflection point, and I look forward to helping them deliver value to both patients and investors in the near and long term."

About Jay Green

Mr. Jay Green, CPA, CA, MAcc, recently completed a 19-year career with GSK across several progressive leadership positions in GSK's three businesses of consumer healthcare, pharmaceuticals, and vaccines, as well as corporate development. He also led GSK's global enterprise resource planning (ERP) program, one of the largest IT-enabled business transformation programs in the company's history. Mr. Green most recently served from 2014 to 2020 as Senior Vice President, Finance and CFO of GSK's global vaccines business. Since 2020, Mr. Green has served in an advisory role to Gavi for COVAX, an international initiative to support equitable distribution of COVID-19 vaccines. He is a Chartered Professional Accountant who holds a Master of Accounting from the University of Waterloo, Ontario, Canada.
๐Ÿ‘๏ธ0
starkd748 starkd748 2 years ago
Dilution yeeeehaw
๐Ÿ‘๏ธ0
midastouch017 midastouch017 2 years ago
BiondVax Announces Pricing of $9.0 million Follow-on Underwritten Offering of American Depositary Shares

JERUSALEM, Dec. 27, 2021 /PRNewswire/ -- BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV), a biopharmaceutical company focused on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses, today announced the pricing of an underwritten public offering of 3,813,560 American Depositary Shares ("ADSs") at a public offering price of $2.36 per ADS for gross proceeds to the Company of approximately $9.0 million, before deducting underwriting discounts and other offering expenses. Each ADS represents 40 ordinary shares of BiondVax.

BiondVax intends to use the net proceeds from this offering for the advancement of its recently announced nanosized antibody (NanoAb) development program as well as for general corporate purposes, including, but not limited to, working capital, research and development activities, regulatory matters, capital investment or other related purposes. It may also use a portion of any net proceeds to in-license, invest in or acquire businesses, assets or technologies that it believes are complementary to its business focus, although it has no current commitments or agreements in those regards.

The offering is expected to close on or about December 29, 2021, subject to customary closing conditions. In connection with the offering, the Company has also granted the underwriters a 45-day option to purchase additional ADSs offered to the public at the public offering price, less underwriting discount, for covering over-allotments, if any. If the over-allotment option is exercised in full it would increase the total gross proceeds of the offering to approximately $9.8 million.

Aegis Capital Corp. is acting as the sole book-running manager for the offering.
๐Ÿ‘๏ธ0
midastouch017 midastouch017 2 years ago
BiondVax gains on collaboration to develop nanosized COVID-19 antibody therapy

Dec. 22, 2021 9:06 AM ETBiondVax Pharmaceuticals Ltd. (BVXV)

By: Dulan Lokuwithana, SA News Editor


Nano-cap stock, BiondVax Pharmaceuticals (NASDAQ:BVXV) has more than doubled in the pre-market on above-average volume after announcing the signing of definitive agreements with two German institutes for the development and commercialization of COVID-19 nanosized antibodies.

The agreements with Max Planck Society (MPG) and the University Medical Center Göttingen (UMG) are part of a broader partnership expected to be signed in Jan. 2022, the company announced.

The lead NanoAb COVID-19 candidates in the program have a robust competitive advantage over the current treatments for the disease, BiondVax (BVXV) argues. The company cites their ability to bind the target at concentrations 100-times lower than those required by commercially available monoclonal antibody treatments for COVID-19.
In addition, their smaller size and hyper-thermostability should enable an inhalational mode of administration with longer shelf life and avoid the need for enhanced cold chain storage, according to BiondVax (BVXV).

The company expects to advance preclinical studies for COVID-19 NanoAb in 2022, with data from early human clinical trials anticipated in 2023.

Israel-based BiondVax (BVXV) announced a 5-year strategic research collaboration with the two German institutes in October. The deal was subject to the execution of definitive agreements, the company said at the time.

๐Ÿ‘๏ธ0
europtiger europtiger 2 years ago
Just got 2,90โ€˜sโ€ฆ. Little lateโ€ฆ but see 5$ here
๐Ÿ‘๏ธ0
pennystock_es pennystock_es 2 years ago
$BVXV signs definitive agreements for development and commercialization of innovative nanosized COVID-19 antibody therapy with Max Planck Institute of Biophysical Chemistry and University Medical Center Göttingen, Germany

https://ih.advfn.com/stock-market/NASDAQ/biondvax-pharmaceuticals-BVXV/stock-news/86874583/biondvax-signs-definitive-agreements-for-developme
๐Ÿ‘๏ธ0
Marvy Marvy 2 years ago
Monster today!!! Its coming low float. Covid news...
๐Ÿ‘๏ธ0
midastouch017 midastouch017 2 years ago
BiondVax signs definitive agreements for development and commercialization of innovative nanosized COVID-19 antibody therapy with Max Planck Institute of Biophysical Chemistry and University Medical Center Göttingen, Germany

https://finance.yahoo.com/news/biondvax-signs-definitive-agreements-development-120700203.html

- Max Planck Institute of Biophysical Chemistry, a world leading research institute, together with University Medical Center Göttingen have developed unique nanosized antibodies (NanoAbs*) for the treatment of COVID-19 that exhibit significant competitive advantages over existing therapies;

- BiondVax to lead development and commercialization with exclusive worldwide license; initial human clinical trials results expected in 2023;

- In-vitro data shows neutralization of all COVID-19 variants of concern including Delta, and based on in-silico studies, Omicron, at significantly lower dose levels than existing antibody treatments; These NanoAbs are also stable at very high temperatures and will be developed for convenient inhalation administration targeting the virus directly in the lungs and airways;

- Broader collaboration for the development of additional NanoAbs addressing diseases with large unmet medical needs and attractive commercial opportunities expected to be signed in January 2022.

JERUSALEM, Dec. 22, 2021 /PRNewswire/ -- BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a biopharmaceutical company focused on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses, today announced the signing of definitive agreements with the Max Planck Society (MPG), the parent organization of the Max Planck Institute of Biophysical Chemistry, and the University Medical Center Göttingen (UMG), both in Germany, to enter into a strategic collaboration for the development and commercialization of innovative COVID-19 nanosized antibodies (NanoAbs*). These agreements are part of a broader collaboration, expected to be signed in January 2022, covering development and commercialization of NanoAbs for several other disease indications with large market sizes that leverage their unique binding affinity, stability at high temperatures, and potential for more effective and convenient routes of administration.

The lead NanoAb candidates for the COVID-19 program, developed by Professor Dirk Görlich, Director at the Max Planck Institute of Biophysical Chemistry, and Professor Matthias Dobbelstein, Professor of Molecular Oncology at the UMG, exhibit a strong competitive edge over existing COVID-19 therapies. For example, the NanoAbs exhibit superior affinity to the target, neutralizing the SARS-COV-2 virus, in-vitro, at drug concentrations about 100-times lower than those required by currently commercially available monoclonal antibodies. This may lead to increased efficacy, reduced side effects, and allow production at a lower cost. In addition, the NanoAbs' small size and hyper-thermostability at 95°C (200°F) potentially enables administration through inhalation and longer shelf life, and potentially avoids the need for enhanced cold chain storage and transport. Together, these attributes are designed to create significant competitive advantages.

The NanoAbs have demonstrated strong neutralization at very low concentrations of major Variants of Concern (VoCs) including Alpha, Beta, Gamma and Delta in in-vitro studies in Görlich's and Dobbelstein's laboratories and based on in-silico studies, are expected to neutralize Omicron. Given the potential of additional emerging VoCs, the BiondVax-MPG-UMG collaboration covers development of new NanoAbs as needed during the evolution of COVID-19. The methodologies employed by the Görlich and Dobbelstein labs enable generation of new NanoAb candidates within weeks of acquiring the sequence for any emerging variant, and thereby positions BiondVax to stay at the forefront of COVID-19 preparedness.

In addition to the COVID-19 NanoAb collaboration and as previously announced, BiondVax, MPG and UMG have signed a term-sheet for development of NanoAbs towards other indications with major opportunities in key therapeutic areas of psoriasis, asthma, macular degeneration, and psoriatic arthritis. These are all diseases with known and validated antibody drug targets (thereby shortening development timelines and lowering risk), and where the NanoAb advantages have the potential to capture significant market share. BiondVax anticipates finalizing the collaboration agreements for these additional NanoAbs in January 2022.

BiondVax is planning a rapid development path that leverages the company's expertise and capabilities in biological drug development and manufacturing. In particular, NanoAbs can be mass-produced through recombinant protein manufacturing in sites such as BiondVax's GMP biologics manufacturing facility in Jerusalem. BiondVax anticipates conducting COVID-19 NanoAb preclinical studies in 2022 with initial human clinical trials results in 2023.

Mr. Amir Reichman, BiondVax's CEO, commented, "As Omicron's recent and rapid emergence makes clear, improved therapeutics are needed to bring COVID-19 under control. The innovative COVID-19 NanoAb candidates offer the potential for a superior therapeutic platform. Overall, the NanoAb platform is an incredible opportunity for BiondVax. It will serve as a basis for an exciting new pipeline of commercially attractive products to address unmet therapeutic needs of diseases such as psoriasis, psoriatic arthritis, asthma, and macular degeneration. The technology is a great fit to our manufacturing site in Jerusalem and our experience and expertise in biological drug development. I wish to thank Professors Görlich and Dobbelstein for their enthusiasm for this project, and Max Planck Innovation's technology transfer team including Dr. Dieter Link for their assistance in developing this innovative collaboration. BiondVax is in the process of a transformative turnaround, and I am highly confident that these NanoAb therapies present compelling commercial potential and will address important healthcare needs."

Professor Dirk Görlich, Director at the Max Planck Institute for Biophysical Chemistry, commented, "We believe that the innovative platform developed at the Max Planck Institute for Biophysical Chemistry and the University Medical Center of Göttingen has great potential to provide patients with superior therapies. We are particularly pleased to team with BiondVax to use their drug development and manufacturing capabilities and expertise to advance the COVID-19 nanosized antibodies through additional development towards marketing approvals."

The collaboration has been facilitated by kENUP, a civic society organization promoting innovative industries in Europe.
๐Ÿ‘๏ธ0
xLeGenDx xLeGenDx 2 years ago
Been loading all I can sub $2.10, havenโ€™t got any of my orders filled for a while? Might have to move my order to the next buying zone. Iโ€™ll check back tmr and gauge it. When this goes, itโ€™s gonna go!
๐Ÿ‘๏ธ0
trendzone trendzone 3 years ago
Twitter pumpbag BSS pumping on the high amount of shorts that brought it down, they shorted it for a reason just about all Israeli stocks suck and are nothing but pump and dump trash, everyone I ever bought goes into the red and stays there, and all the big guys know it and short them back down after every pop, holding two pieces of izrailroad stocks right now that trade like a total piece of toxic garbage, and they will be the last I will ever buy again from over there, when a stock pops first thing I do is make sure it's not from over there, if it is won't touch it, you buy it then the next day it's dead red as usual, not sure why it's that's way, other than these is a lot of criminal scammers running scams over there, and just every company is always looking to put a buck in their pockets with toxic dilutiion.
๐Ÿ‘๏ธ0
cov20 cov20 3 years ago
It has been getting more activities recently
๐Ÿ‘๏ธ0
wesley_ wesley_ 3 years ago
$3.10 time to load some
๐Ÿ‘๏ธ0
midastouch017 midastouch017 3 years ago
Letter from BiondVax's New CEO to Shareholders

March 23 2021 - 07:44AM
PR Newswire (US)
JERUSALEM, March 23, 2021 /PRNewswire/ --

Amir Reichman, BiondVax CEO

Dear Shareholders,

After many years of pharmaceutical leadership positions in the US and Europe, I jumped at the opportunity to return to my roots in Israel to take over the reins as BiondVax's CEO. Since my appointment was announced in January, I had been wrapping up my role as Head of Global Vaccines Engineering, Core Technologies, and Asset Management at GSK Vaccines headquarters in Belgium. I started as BiondVax's full time CEO on March 2nd and intend to relocate to Israel this coming summer. In the meantime, I will be traveling between Belgium and Israel.

The first thing I have done as the new CEO, together with our Board of Directors, was to define a new mission and vision for BiondVax. Our new mission reflects an aspiration to focus on infectious diseases, which leverages BiondVax's core competencies, while ensuring diversification of our corporate risks through the establishment of a new, broad product and platform pipeline.

BiondVax's mission is to help build a healthier and happier world by developing, manufacturing and ultimately commercializing products for the prevention and treatment of infectious diseases and related illnesses.

In the past, BiondVax was a one product company, solely focused on developing the M-001 universal influenza vaccine. Going forward, my intent in rejuvenating BiondVax is to implement a strategy that will diversify the risk along several axes:

Build a pipeline of products not only for prevention (through vaccines) but also for treatment of infectious diseases and related illnesses
Build a pipeline that would present various routes of drug delivery (e.g., intra-muscular, nasal, oral, etc.)
Build a pipeline that would rely on various platforms (different types of molecules and manufacturing platforms)
Build a pipeline of products at different stages of clinical development
If successfully implemented, this strategy would provide BiondVax with a robust and diverse multi-dimensional pipeline. Over these past few months, we have been actively engaged in identifying and evaluating many opportunities. These include in-licensing, acquisitions, and joint ventures, with industry, academia, and governments. Indeed, we are currently engaged in due diligence and negotiations on a number of exciting potential opportunities.

I would like to share with you what attracted me to BiondVax. I believe that BiondVax presents a unique set of strong capabilities along the three most important pillars of business management: People, Process and Technology. In my view, these capabilities, if managed correctly, could prove to be a serious competitive advantage versus other bio-pharma companies of comparable size and value, and serve as a jumping board for a revitalized and rebuilt company.

People: Our leadership team has deep and highly relevant biotech and pharmaceutical industry experience, including our Chairman Mark Germain (Alexion, Neurocrine, Pluristem and others), Board director Samuel Moed (Bristol Myers Squibb), and COO Elad Mark (Novartis). As CEO, I bring a background of extensive vaccines R&D, supply chain, manufacturing, and engineering at a global level from Novartis in the USA and GSK in Europe. Furthermore, our Chief Science Officer, Dr. Tamar Ben-Yedidia, ushered a novel influenza vaccine candidate from R&D at the Weizmann Institute through eight clinical trials culminating in a 12,400 participant, seven country, two season pivotal Phase 3 clinical trial. Dr. Ben-Yedidia conducted her preliminary research in the 1990's under the guidance of Professor Ruth Arnon, co-inventor of Teva Pharmaceutical's blockbuster Copaxone drug; Professor Arnon continues to serve as head of BiondVax's Scientific Advisory Board.

Process: Thanks to 18 years of experience, BiondVax has developed a mature set of business processes including pre-clinical and clinical development, regulatory, quality, GMP manufacturing processes and more. We are still under a master services agreement with our CRO, with whom we partnered for our recent Phase 3 clinical trial, and through which we retain access to over 90 medical centers in their investigational site network which can rapidly be re-activated should we in-license a clinical stage asset. These processes can help us accelerate time to market for future in-licensed assets and hence provide us with a competitive value proposition versus other companies our size.

Technology: Our existing and highly advanced GMP vaccine manufacturing facility in Jerusalem uses an agile and modular 'Single Use' infrastructure that can be used for a wide variety of applications and technologies, such as the production of recombinant proteins, RNA, monoclonal antibodies, and other vaccines and treatments. In addition, we have advanced automation, data management and IT systems necessary for regulatory compliant clinical development, clinical supplies and commercial supplies.

Looking back over 2020, the results of the Phase 3 clinical trial of our M-001 universal influenza vaccine candidate were deeply disappointing for our management, employees, shareholders, and all our other stakeholders. While clinical effectiveness of M-001 versus a placebo was not observed in the trial, there was evidence of robust immune responses in the seven previous clinical trials. Thus, we believe our vaccine still has potential and under different trial settings it is possible that clinical effectiveness would be observed. For this reason, we have not discarded M-001 but rather placed it on the shelf for the time being, in the hope that we may revisit it in the future.

While the Phase 3 trial of M-001 did not meet its clinical endpoints, a common occurrence in the industry, the employees and Board of Directors devoted a tremendous amount of time and effort to ensure that the trial was properly managed, completed on time and on budget despite the looming threat of the COVID-19 pandemic. This by itself was a major achievement for any company in the industry, much less a relatively small biotech firm.

On April 6, BiondVax will host an extraordinary meeting of shareholders to approve my terms of office as CEO of BiondVax, approve compensation packages, and expand our authorized share capital to provide flexibility in raising additional capital in the future. While we will seek to fund our growth in a manner that enhances long-term shareholder value, equity remains an important component in the financing strategy of building the prospective diverse portfolio of products, drug delivery technologies and platforms that I described earlier.

You, our shareholders, have an important say in these measures which we believe are essential steps towards realizing BiondVax's new mission and vision. On behalf of Management and the Board, we would be grateful for your continued support by voting in line with our recommendations on the proxy. Details are available on the SEC website[1], and we urge you to contact your broker to exercise your right to vote. You may also contact my investor relations team at any time for any query you may have or information you require.

Under my new leadership, I believe BiondVax is well positioned to become a globally trusted and preferred bio-pharmaceutical company known for fast and efficient product development of highly innovative products, offering a reliable supply of high-quality and effective prophylactic and therapeutic products targeting infectious diseases and related illnesses.

I pledge to keep you updated as we progress towards our important and exciting goals.

Sincerely,
Amir Reichman
CEO
BiondVax Pharmaceutical Ltd.
๐Ÿ‘๏ธ0
midastouch017 midastouch017 3 years ago
12-month price target for BiondVax Pharmaceuticals Ltd. (NASDAQ:BVXV) now sits at $30

By Linda Haig -March 6, 2021

https://marketingsentinel.com/2021/03/06/12-month-price-target-for-biondvax-pharmaceuticals-ltd-nasdaqbvxv-now-sits-at-30/

Wall Street analysts have assigned a consensus price target of $30 to the stock, which implies a rise of 728.73% to its current value. Analysts have been projecting $30 as a low price target for the stock while placing it at a high target of $30. It follows that stockโ€™s current price would jump +728.73% in reaching the projected high whereas dropping to the targeted low would mean a loss of 728.73% for stockโ€™s current value.

LOL, I wish
๐Ÿ‘๏ธ0
pennystock_es pennystock_es 3 years ago
Biden to announce Merck will help make Johnson & Johnson's coronavirus vaccine. $BVXV has a vaccine plant in ISRAEL, it could manufacture to end COVID19

https://www.nbcnews.com/politics/white-house/biden-announce-merck-will-help-manufacture-johnson-johnson-s-coronavirus-n1259262
๐Ÿ‘๏ธ0
pennystock_es pennystock_es 3 years ago
The problem of $BVXV is the shorts ... in its day millions of shares (selling from $80 to $4) were traded in the open thinking that $BVXV would disappear, but the surprise has come when a new CEO is hired with a new one strategy for this BIOTECHNOLOGY with 15 years of research, patents etc ... and a modern vaccine laboratory. Be aware of the next days / weeks to bounce between $10 and $20 at least
๐Ÿ‘๏ธ0
pennystock_es pennystock_es 3 years ago
BiondVax Announces Closing of $12.1 Million Follow-on Underwritten Offering
11 minutes ago, 10:30 p. m. CET
Via PR Newswire
Stocks mentioned: BVXV
๐Ÿ‘๏ธ0
midastouch017 midastouch017 3 years ago
BiondVax Announces Pricing of $12.1 Million Follow-on Underwritten Offering of American Depositary Shares

JERUSALEM, Jan. 29, 2021 /PRNewswire via COMTEX/ -- JERUSALEM, Jan. 29, 2021 /PRNewswire/ -- BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a biopharmaceutical company focused on developing, manufacturing and ultimately commercializing products for the prevention and treatment of infectious diseases and related illnesses, today announced the pricing of an underwritten public offering of 2,434,783 American Depositary Shares ("ADSs"), each representing forty ordinary shares, at a public offering price of $4.95 per ADS, for gross proceeds to the Company of approximately $12.1 million, before deducting underwriting discounts and other offering expenses.

BiondVax intends to use the net proceeds from the offering, together with its existing cash and cash equivalents, for general corporate purposes, which may include working capital, research and development activities, regulatory matters, capital investment or other related purposes. The Company may also use a portion of any net proceeds to in-license, invest in or acquire businesses, assets or technologies that BiondVax believes are complementary to its business focus, although BiondVax has no current commitments or agreements in those regards.

The offering is expected to close on or about February 2, 2021, subject to customary closing conditions. In connection with the offering, the Company has also granted the underwriters a 30-day option to purchase up to an additional 15% of the number of ADSs offered to the public at the public offering price, less underwriting discount, for covering over-allotments, if any. If the over-allotment option is exercised in full it would increase the total gross proceeds of the offering to approximately $13.8 Million.

Aegis Capital Corp. is acting as the sole book-running manager for the offering.
๐Ÿ‘๏ธ0
midastouch017 midastouch017 3 years ago
BiondVax Announces Launch of Proposed Underwritten Follow-on Offering of American Depositary Shares

Published: Jan. 28, 2021 at 6:48 p.m. ET

JERUSALEM, Jan. 28, 2021 /PRNewswire via COMTEX/ -- JERUSALEM, Jan. 28, 2021 /PRNewswire/ -- BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a biopharmaceutical company focused on developing, manufacturing and ultimately commercializing products for the prevention and treatment of infectious diseases and related illnesses, today announced its intention to offer its American Depositary Shares ("ADSs") in an underwritten public offering. In connection with the offering, BiondVax expects to grant the underwriter a 30-day option to purchase up to an additional 15% of the ADSs to be sold in the offering to cover over-allotments, if any. The ADSs are being offered by BiondVax pursuant to an effective shelf registration statement on file with the Securities and Exchange Commission (the "SEC").

BiondVax intends to use the net proceeds from the offering, together with its existing cash and cash equivalents, for general corporate purposes, which may include working capital, research and development activities, regulatory matters, capital investment or other related purposes. The Company may also use a portion of any net proceeds to in-license, invest in or acquire businesses, assets or technologies that BiondVax believes are complementary to its business focus, although BiondVax has no current commitments or agreements in those regards.

Aegis Capital Corp. is acting as the sole book-running manager for the offering.

The offering is subject to market conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

The ADSs described above are being offered by the Company pursuant to a registration statement that was previously filed with the SEC and declared effective by the SEC on August 10, 2020. A prospectus supplement and accompanying base prospectus relating to and describing the final terms of the offering will be made available on the SEC's website located at www.sec.gov or from Aegis Capital Corp., Attention: Syndicate Department, 810 7th Avenue, 18th Floor, New York, NY 10019, by email at syndicate@aegiscap.com, or by telephone at (212) 813-1010.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities described herein, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.
๐Ÿ‘๏ธ0

Your Recent History

Delayed Upgrade Clock