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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) will report its third quarter 2021 financial results on November 4, 2021, after market close. The company will host a conference call and live audio webcast on the same day at 4:30 p.m. ET. Interested parties can access the webcast via the company’s investors' section. Dynavax is known for developing HEPLISAV-B, a hepatitis B vaccine, and is advancing its CpG 1018 adjuvant through research collaborations targeting vaccines for various diseases.
Dynavax Technologies Corporation (Nasdaq: DVAX) announced the granting of nonstatutory stock options for 115,000 shares to a new employee, effective October 18, 2021. The options have an exercise price of $17.14, aligned with the stock's closing price on the grant date. These options have a 7-year term and vest over three years, with one-third vesting after one year and the remainder in monthly installments. This grant adheres to Nasdaq Listing Rule 5635(c)(4) and follows their 2021 Inducement Award Plan for new hires.
Dynavax Technologies Corporation (Nasdaq: DVAX) announced positive topline results from Valneva's Phase 3 trial of the inactivated COVID-19 vaccine candidate, VLA2001, which utilizes Dynavax's CpG 1018 adjuvant. The trial met co-primary endpoints, demonstrating superiority over AstraZeneca's AZD1222 in geometric mean titers of neutralization antibodies and non-inferiority in seroconversion rates among adults aged 30 and older. VLA2001 showed a favorable tolerability profile with significantly fewer adverse events compared to AZD1222. Dynavax supports Valneva's continued development of the vaccine.
Dynavax Technologies Corporation (Nasdaq: DVAX) has secured a $22 million agreement with the U.S. Department of Defense to develop a recombinant plague vaccine using its CpG 1018 adjuvant over two and a half years. This collaboration includes a planned Phase 2 clinical trial, expected to commence in 2022, to assess the vaccine's immunogenicity, safety, and tolerability for adults aged 18 to 55 years. The initiative aims to enhance vaccine effectiveness and could lead to future commercial agreements with the U.S. government.
On October 1, 2021, Dynavax Technologies Corporation (Nasdaq: DVAX) announced the grant of 40,000 nonstatutory stock options to a newly-hired employee as part of their inducement for joining the company. The options are priced at $16.84 per share, equal to the stock's closing price on the grant date. They have a seven-year term, vesting over three years, with one-third vesting after one year and the remainder vesting monthly. This grant complies with Nasdaq Listing Rule 5635(c)(4) and is part of Dynavax's 2021 Inducement Award Plan.
Dynavax Technologies Corporation (Nasdaq: DVAX) will participate in several upcoming investor conferences, showcasing its commitment to vaccine development. Key presentations include the 2021 Cantor Virtual Global Healthcare Conference on September 30 at 12:00 p.m. E.T., the Guggenheim 2nd Annual Vaccine and Infectious Disease Conference on October 5 at 12:00 p.m. E.T., and the H.C. Wainwright 2nd Hepatitis B Virus Virtual Conference on October 13 at 12:00 p.m. E.T.. All events will be available via live webcast on their website's 'Events & Presentations' page.
On September 22, 2021, Dynavax Technologies (Nasdaq: DVAX) announced positive results from Clover Biopharmaceuticals' Phase 2/3 SPECTRA trial for their COVID-19 vaccine candidate, SCB-2019, adjuvanted with Dynavax's CpG 1018. The trial, involving over 30,000 participants, demonstrated 100% efficacy against severe COVID-19 and 84% against moderate-to-severe cases, achieving a 79% efficacy against the Delta variant. The vaccine showed a favorable safety profile, with adverse events balanced between vaccine and placebo groups. Clover plans to seek regulatory approvals in Q4 2021, potentially launching the vaccine by year-end.
Dynavax Technologies (Nasdaq: DVAX) announced that Valneva SE received a termination notice from the UK government regarding its COVID-19 vaccine supply agreement for VLA2001. Despite this, Valneva plans to continue clinical trials for VLA2001, with results expected in Q4 2021. Dynavax reiterated a potential revenue opportunity of $300-$400 million for its CpG 1018 adjuvant in 2021, contingent upon ongoing partnerships. There are concerns regarding the impact on Dynavax if Valneva cancels any purchase orders for CpG 1018, but no cancellations have occurred yet.
Dynavax Technologies Corporation (Nasdaq: DVAX) announces that CEO Ryan Spencer will present at the H.C. Wainwright 23rd Annual Global Investment Conference, scheduled for September 13-15, 2021.
The on-demand presentation will be accessible starting September 13, 2021, at 7:00 a.m. E.T. via the Company's Investors section. Dynavax focuses on the development and commercialization of vaccines, including its first product, HEPLISAV-B®, for Hepatitis B prevention.
Dynavax Technologies Corporation (Nasdaq: DVAX) announced the granting of nonstatutory stock options for 224,000 shares to 8 new employees as an inducement for their employment. The options, priced at $19.00 per share, match the closing stock price on the grant date, September 1, 2021. The options vest over three years, with one-third vesting on the first anniversary and the remainder vesting in monthly increments. This grant complies with Nasdaq Listing Rule 5635(c)(4) and follows the company's 2021 Inducement Award Plan.