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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) has announced a commercialization agreement with Bavarian Nordic for the marketing and distribution of HEPLISAV B, a hepatitis B vaccine, in Germany. The expected launch is set for Q4 2021. HEPLISAV B is the only approved hepatitis B vaccine for adults involving a two-dose regimen completed in one month, boasting a higher seroprotection rate compared to traditional three-dose vaccines. This collaboration capitalizes on Bavarian Nordic's established marketing network in Germany, aimed at improving vaccine accessibility and compliance.
Dynavax Technologies (Nasdaq: DVAX) will participate in a virtual fireside chat at the William Blair 41st Annual Growth Stock Conference on June 1, 2021, at 2:40 p.m. C.T. The chat will be led by CEO Ryan Spencer and will be accessible via the company's 'Events & Presentations' page. Dynavax is known for its innovative vaccines, including HEPLISAV-B®, a hepatitis B vaccine approved in both the U.S. and EU, and is advancing its CpG 1018 adjuvant for COVID-19 and other vaccines.
Dynavax Technologies Corporation (Nasdaq: DVAX) announced the pricing of $200 million in 2.50% convertible senior notes due 2026. The offering closes on May 13, 2021, with an option for purchasers to buy an additional $30 million. The notes accrue interest semiannually and have a conversion rate of 95.5338 shares per $1,000 principal. The net proceeds, estimated at $195.1 million, will primarily be used to repay outstanding debts. Dynavax will also engage in capped call transactions to mitigate potential stock dilution, with a cap set at $15.80.
Dynavax Technologies Corporation (Nasdaq: DVAX) announced its plan to offer $200 million of convertible senior notes due 2026, with an option for purchasers to buy an additional $30 million. The notes will be unsecured and accrue interest payable semiannually, convertible into cash or stock at Dynavax's discretion. Proceeds will be used to repay existing debt and fund capped call transactions to mitigate stock dilution. The offering is subject to market conditions and is not registered under the Securities Act.
Dynavax Technologies (DVAX) reported a robust first quarter of 2021, achieving total revenues of $83.3 million, a significant increase from $10.9 million in Q1 2020. The company attributed this growth to strong performance from CpG 1018, generating $74.6 million in revenue, while HEPLISAV-B reached $8.3 million despite a decline in vaccine utilization. Notable metrics included an 89.3% seroprotection rate from ongoing clinical trials and a cash position of $232.7 million. The company expects 2021 to be transformational, driven by collaborations and product advancements.
Dynavax Technologies (Nasdaq: DVAX) announced on May 4, 2021 that it granted nonstatutory stock options for 148,500 shares to seven newly-hired employees as an employment inducement. The options were awarded at an exercise price of $9.74 per share, equal to the stock's closing price on the grant date, May 3, 2021. These options have a 7-year term and vest over three years, with one-third vesting annually and remaining shares monthly. This initiative complies with Nasdaq Listing Rule 5635(c)(4) and is part of the 2021 Inducement Award Plan.
Dynavax Technologies announced findings from a post-marketing study presented at the 2021 Annual Conference on Vaccinology Research. The study, which included approximately 31,000 patients receiving HEPLISAV-B and 38,000 receiving Engerix-B, showed an acute myocardial infarction (AMI) rate of 1.67 for HEPLISAV-B versus 1.86 for Engerix-B. The hazard ratio of 0.92 indicates no increased AMI risk with HEPLISAV-B. These results confirm the safety profile of HEPLISAV-B, supporting its continued use in hepatitis B prevention.
Dynavax Technologies Corporation (Nasdaq: DVAX) will release its first quarter 2021 financial results on May 6, 2021, after market close. A conference call and audio webcast will follow at 4:30 p.m. ET. The company focuses on developing vaccines, with its first product, HEPLISAV-B®, already approved in the U.S. and EU for hepatitis B prevention in adults. Dynavax continues to advance its CpG 1018 adjuvant through collaborations for COVID-19, pertussis, and universal influenza vaccines.
Dynavax Technologies Corporation (Nasdaq: DVAX) announces that Valneva SE has initiated a pivotal Phase 3 clinical trial for its COVID-19 vaccine candidate VLA2001, utilizing Dynavax's CpG 1018 adjuvant. The Cov-Compare trial aims to compare VLA2001 against AstraZeneca's Vaxzevria in a study involving 4,000 adults, focusing on the superior neutralizing antibody response. Following promising Phase 1/2 results, Valneva plans regulatory submission in autumn 2021 if Phase 3 results are favorable, marking a significant step in COVID-19 vaccine development.
Dynavax Technologies Corporation (Nasdaq: DVAX) announced that two abstracts related to its hepatitis B vaccine, HEPLISAV-B, will be presented at the 2021 Annual Conference on Vaccinology Research (ACVR) scheduled for April 26-27, 2021. The first abstract evaluates the safety and immunogenicity of HEPLISAV-B in adults undergoing hemodialysis, while the second presents findings on the occurrence of acute myocardial infarction in over 60,000 patients vaccinated with HEPLISAV-B compared to another vaccine. These presentations can be viewed on-demand until June 30, 2021.