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Dynavax Technologies Corporation (Nasdaq: DVAX) is a prominent clinical-stage biopharmaceutical firm dedicated to developing innovative vaccines targeting infectious and inflammatory diseases, as well as cancer. With its headquarters in Emeryville, California, the company is renowned for leveraging the body's innate and adaptive immune responses through its proprietary Toll-like Receptor Immune Modulation Platform technology.
Core Products and Clinical Pipeline:
- HEPLISAV-B®: Approved in the U.S., EU, and Great Britain, HEPLISAV-B is the first and only adult hepatitis B vaccine that allows series completion with just two doses in one month. It continues to show strong market expansion and revenue growth.
- CpG 1018® Adjuvant: An essential component in multiple adjuvanted COVID-19 vaccines, this adjuvant enhances the immune response.
- Shingles Vaccine Program (Z-1018): In development for preventing shingles in adults aged 50 and older, promising robust immune responses.
- Tdap Vaccine Program (Tdap-1018): Focused on active booster immunization against tetanus, diphtheria, and pertussis.
- Plague Vaccine Program (DV2-PLG-01): In Phase 2 clinical trials, this program is fully funded by the U.S. Department of Defense.
Recent Achievements and Financial Highlights:
- Dynavax reported record revenue growth for HEPLISAV-B in 2023, capturing significant market share in the adult hepatitis B vaccine sector.
- As of December 31, 2023, the company had cash, cash equivalents, and marketable securities worth $742.3 million, underpinning its strong financial foundation.
- For the first quarter of 2024, Dynavax's net loss was reduced compared to the same period in 2023, due to improved operational efficiencies and strategic market initiatives.
Strategic Partnerships:
Collaborations with global biopharmaceutical companies, including AstraZeneca in Europe, further strengthen Dynavax's market position and broaden its product reach.
For detailed financial information and ongoing updates, investors can access the company's Events & Presentations page on their official website.
Dynavax Technologies Corporation (Nasdaq: DVAX) announced positive results from Valneva's Phase 1/2 trial of its COVID-19 vaccine candidate, VLA2001, featuring Dynavax's CpG 1018 adjuvant. The trial involved 153 healthy adults aged 18 to 55, showing a 100% seroconversion rate for S-protein binding IgG in the high dose group. Valneva aims to start a pivotal Phase 3 trial by the end of April 2021, pending regulatory approval. VLA2001 is designed to prevent COVID-19 and may be modified for new variants.
Dynavax Technologies (Nasdaq: DVAX) announced the grant of nonstatutory stock options to purchase 142,000 shares to six new hires. The options, granted on April 1, 2021, have an exercise price of $9.73 per share, equaling the stock's closing price on that date. Each option has a 7-year term and vests over three years, tied to continued employment. This action complies with Nasdaq Listing Rule 5635(c)(4) and is part of Dynavax's 2021 Inducement Award Plan, aimed at attracting talent in the biopharmaceutical sector.
Clover Biopharmaceuticals and Dynavax Technologies announced the dosing of the first participants in the global Phase 2/3 SPECTRA trial, evaluating Clover's S-Trimer COVID-19 vaccine candidate. This double-blind, randomized study aims to assess the vaccine's efficacy, safety, and immunogenicity in over 22,000 adults across multiple continents. An interim analysis is expected in mid-2021. The trial is fully funded by the Coalition for Epidemic Preparedness Innovations, with hopes of producing hundreds of millions of doses for global distribution, emphasizing the vaccine's stability and manufacturing potential.
Dynavax Technologies Corporation (Nasdaq: DVAX) will present at the H.C. Wainwright Virtual 2021 Global Life Sciences Conference on March 9-10, 2021. CEO Ryan Spencer will lead the presentation, which will be available on demand starting at 7:00 a.m. E.T. on March 9, accessible via the Investors section of the company’s website. Dynavax specializes in developing vaccines, having commercialized HEPLISAV-B®, a hepatitis B vaccine, and is advancing CpG 1018 as a vaccine adjuvant for various collaborations.
Dynavax Technologies Corporation (Nasdaq: DVAX) announced the grant of stock options totaling 350,000 shares to its newly appointed Senior Vice President and Chief Financial Officer, Ms. MacDonald, effective March 1, 2021. Additionally, the company issued 74,300 shares in stock options to four newly hired employees. These options have a 7-year term, vesting over three years, with an exercise price of $8.90, reflecting the closing price on the grant date. This move complies with Nasdaq Listing Rule 5635(c)(4) and is aimed at attracting talent amidst ongoing vaccine developments.
Dynavax Technologies (DVAX) reported its financial results for Q4 and full year 2020, highlighting a net loss of $15.5 million in Q4, improved from a loss of $36.8 million in Q4 2019. Total revenues rose to $46.6 million for 2020, up from $35.2 million in 2019. HEPLISAV-B product revenue reached $36 million, a 4% increase year-over-year. The company anticipates significant revenue from collaborations utilizing its adjuvant CpG 1018, potentially generating up to $230 million in 2021. Cash reserves stood at $165 million at the end of 2020.
Dynavax Technologies Corporation (Nasdaq: DVAX) announced that the European Commission has granted marketing authorization for HEPLISAV B, a two-dose hepatitis B vaccine for adults aged 18 and older. This approval follows a positive opinion from the European Medicines Agency based on favorable safety and immunogenicity results from three Phase 3 trials. Hepatitis B is highly infectious, affecting over 250 million globally. With a higher seroprotection rate than traditional vaccines, HEPLISAV B aims to improve compliance and is expected to launch in Europe later this year.
Dynavax Technologies Corporation (NASDAQ: DVAX), a biopharmaceutical company, announced that CEO Ryan Spencer will present at the Cowen 41st Annual Health Care Conference on March 1, 2021, at 3:20 p.m. E.T. The presentation will be available via webcast on the Company’s investors website. Dynavax is known for its vaccine development, particularly HEPLISAV-B®, approved for hepatitis B prevention in adults, and is advancing CpG 1018 as a vaccine adjuvant for various diseases.
Dynavax Technologies Corporation (Nasdaq: DVAX) announced it will report its fourth quarter and full year 2020 financial results on February 25, 2021, after market close. The company will host a conference call at 4:30 p.m. ET the same day. Investors can access the live audio webcast on the company's website. Dynavax focuses on developing vaccines and has commercialized HEPLISAV-B®, a hepatitis B vaccine. The company is also advancing CpG 1018 as a vaccine adjuvant, collaborating on vaccines for COVID-19, pertussis, and universal influenza.
Dynavax Technologies Corporation (Nasdaq: DVAX) announced the appointment of Dong Yu, Ph.D., as Senior Vice President of Vaccine Research on February 8, 2021. Dr. Yu, with over 15 years of experience in vaccine research, will lead the company's vaccine programs and technology platforms. He previously held significant roles at GSK Vaccines and Novartis Vaccines. As part of his employment, Dr. Yu received a stock option grant for 225,000 shares at an exercise price of $11.18. This appointment aims to bolster Dynavax's growth as a global vaccine leader.