Tetanus toxoid reduced diphtheria toxoid and acellular pertussis vaccine adsorbed(GlaxoSmithKline Plc)

Achieved record quarterly HEPLISAV-B® net product revenue of $70.2 million, growing 24% year-over-year Reaffirming full year 2024 HEPLISAV-B net product revenue guidance of $265 - $280 million Initiated dosing in Phase 1/2 trial of novel shingles vaccine program with clinical data expected in 2H 2025 Conference call today at 4:30 p.m. ET/1:30 p.m. PT EMERYVILLE, Calif., Aug. 6, 2024 /PRNewswire/ -- Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines, today reported financial results and provided a business update for the quarter ended June 30, 2024. "We continue to strengthen our leadership position in the U.S. adult hepatitis B vaccine market with another record quarter for HEPLISAV-B, providing confidence in our current year expectations and reaffirming our long-term view of the product opportunity. We are highly optimistic about the adult hepatitis B vaccine market of over 130 million eligible patients, which is one of the largest addressable patient populations for vaccines in the U.S. We expect the market opportunity for HEPLISAV-B to grow to over $800 million by 2027, and continue expanding through the end of the decade. The expected growth in the market opportunity, combined with our expectations to continue to increase market share, provides a substantial, long-term revenue opportunity for HEPLISAV-B," said Ryan Spencer, Chief Executive Officer of Dynavax. "For our pipeline development, we are pleased to have recently initiated our Phase 1/2 trial for our novel shingles vaccine program, and remain excited for several upcoming milestones, including data readouts from the shingles study as well as our Tdap and plague vaccine programs expected across 2024 and 2025. In addition to this progress, and bolstered by our strong financial position, we continue to evaluate strategic opportunities to accelerate growth, further diversify our portfolio, and deliver value to our shareholders." BUSINESS UPDATES HEPLISAV-B® [Hepatitis B Vaccine (Recombinant), Adjuvanted] HEPLISAV-B vaccine is the first and only adult hepatitis B vaccine approved in the U.S., the European Union and Great Britain that enables series completion with only two doses in one month. Hepatitis B vaccination is universally recommended for adults aged 19-59 in the U.S. HEPLISAV-B vaccine achieved record quarterly net product revenue of $70.2 million for the second quarter of 2024, an increase of 24% compared to $56.4 million for the second quarter of 2023. HEPLISAV-B total estimated market share in the U.S. increased to approximately 42%, compared to approximately 39% for the second quarter 2023. HEPLISAV-B estimated market share in the retail pharmacy segment increased to approximately 59%, compared to approximately 45% for the second quarter of 2023. HEPLISAV-B estimated market share in the Integrated Delivery Networks (IDNs) and Large Clinics segment increased to approximately 56%, compared to approximately 53% for the second quarter 2023. Dynavax expects the HEPLISAV-B market opportunity in the U.S. to expand to over $800 million by 2027, with growth expected to continue to a peak market opportunity by 2030. Dynavax also expects HEPLISAV-B to achieve a majority share of the total U.S. market by 2027, with share gains continuing post-peak market. Additionally, Dynavax expects the HEPLISAV-B market opportunity to remain substantial beyond 2030 due to the ongoing penetration of the unvaccinated adult cohort. Clinical Pipeline Dynavax is advancing a pipeline of differentiated product candidates that leverage its CpG 1018® adjuvant, which has demonstrated its ability to enhance the immune response with a favorable tolerability profile in a wide range of clinical trials and real-world commercial use. HEPLISAV-B for Adults on Hemodialysis Dynavax is developing a four-dose HEPLISAV-B® vaccine regimen for adults on hemodialysis. In May 2024, Dynavax announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) in response to the Company's supplemental Biologics License Application (sBLA) to include a four-dose HEPLISAV-B® vaccine regimen for adults on hemodialysis on the U.S. label. The Company intends to meet with the FDA in the second half of 2024, as part of the standard post-CRL regulatory process, to discuss pathways to amend its sBLA with additional data to support the four-dose regimen for the adult hemodialysis population in the U.S. Shingles vaccine program: Z-1018 is an investigational vaccine candidate being developed for the prevention of shingles in adults aged 50 years and older. In June 2024, Dynavax announced the initiation of a randomized, active-controlled, dose escalation, multicenter Phase 1/2 trial to evaluate the safety, tolerability, and immunogenicity of Z-1018 compared to Shingrix® in approximately 440 healthy adults aged 50 to 69. Dynavax anticipates reporting top line immunogenicity and safety data in the second half of 2025, including a comparison of CD4+ T-cells one month after the second of two vaccine doses. Tdap vaccine program: Tdap-1018 is an investigational vaccine candidate intended for active booster immunization against tetanus, diphtheria, and pertussis (Tdap). Dynavax plans to evaluate the persistence of pertussis immunogenicity of Tdap-1018 through a long-term follow-up study of participants that completed a Phase 1 trial of a booster dose of Tdap-1018 compared to an active control. The extension study is expected to follow participants for up to three years following initial vaccination. Results from the Phase 1 extension study are expected in the fourth quarter of 2024. Plague vaccine program: Dynavax is developing a plague (rF1V) vaccine candidate adjuvanted with CpG 1018® currently in a Phase 2 clinical trial in collaboration with, and fully funded by, the U.S. Department of Defense. Dynavax anticipates providing a program update, based on results from both a randomized, active-controlled Phase 2 clinical trial and a nonhuman primate challenge study of the plague vaccine candidate, in the fourth quarter of 2024. SECOND QUARTER 2024 FINANCIAL HIGHLIGHTS Total Revenues and Net Product Revenue. Total revenues for the second quarter of 2024 were $73.8 million, a 22% year-over-year increase compared to $60.2 million for the second quarter of 2023. HEPLISAV-B net product revenue was $70.2 million for the second quarter of 2024, a 24% year-over-year increase compared to $56.4 million for the second quarter of 2023. Other revenue was $3.6 million for the second quarter of 2024, a 5% decrease compared to $3.8 million for the second quarter of 2023. Other revenue primarily includes revenue from the plague vaccine agreement with the U.S. Department of Defense. Cost of Sales - Product. Cost of sales - product for HEPLISAV-B in the second quarter of 2024 decreased to $12.0 million, compared to $13.5 million for the second quarter of 2023. The decrease was primarily due to lower per-unit manufacturing costs as the result of previous process improvements. Research and Development Expenses (R&D). R&D expenses for the second quarter of 2024 increased to $15.0 million, compared to $13.0 million for the second quarter of 2023. The increase was primarily driven by investments in our discovery, preclinical and clinical pipeline efforts. Selling, General, and Administrative Expenses (SG&A). SG&A expenses for the second quarter of 2024 increased to $41.7 million, compared to $37.1 million for the second quarter of 2023. The increase was primarily driven by increased headcount and other investments supporting our strategic growth. Net Income. Net income was $11.4 million, or $0.09 per share basic and $0.08 diluted in the second quarter of 2024, compared to net income of $3.4 million, or $0.03 per share (basic and diluted) in the second quarter of 2023. Cash and Marketable Securities. Cash, cash equivalents and marketable securities were $735.6 million as of June 30, 2024, compared to $742.3 million as of December 31, 2023. 2024 FINANCIAL GUIDANCE Dynavax is reiterating its full year 2024 financial guidance, based on the Company's current operating plan: HEPLISAV-B net product revenue between approximately $265 - $280 million, including approximately $3 million in ex-U.S. sales through commercialization partnership in Germany HEPLISAV-B gross margin of approximately 80% Research and development expenses between approximately $60 - $75 million Selling, general and administrative expenses between approximately $160 - $180 million Cash, cash equivalents and marketable securities to be higher as of December 31, 2024, compared to December 31, 2023 Conference Call and Webcast Information Dynavax will host a conference call and live audio webcast on Tuesday, August 6, 2024, at 4:30 p.m. ET/1:30 p.m. PT. The live audio webcast may be accessed through the "Events & Presentations" page on the "Investors" section of the Company's website at . A replay of the webcast will be available for 30 days following the live event. To dial into the call, participants will need to register for the call using the caller registration link. It is recommended that participants dial into the conference call or log into the webcast approximately 10 minutes prior to the call. Important U.S. Product Information HEPLISAV-B is indicated for the prevention of infection caused by all known subtypes of hepatitis B virus in adults aged 18 years and older. For full U.S. Prescribing Information for HEPLISAV-B, click here. Important U.S. Safety Information (ISI) Do not administer HEPLISAV-B to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of HEPLISAV-B. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to HEPLISAV-B. Hepatitis B has a long incubation period. HEPLISAV-B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration. The most common patient-reported adverse reactions reported within 7 days of vaccination were injection site pain (23% to 39%), fatigue (11% to 17%), and headache (8% to 17%). About Dynavax Dynavax is a commercial-stage biopharmaceutical company developing and commercializing innovative vaccines to help protect the world against infectious diseases. The Company has two commercial products, HEPLISAV-B® vaccine [Hepatitis B Vaccine (Recombinant), Adjuvanted], which is approved in the U.S., the European Union and Great Britain for the prevention of infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older, and CpG 1018® adjuvant, currently used in HEPLISAV-B and multiple adjuvanted COVID-19 vaccines. Dynavax is advancing CpG 1018 as a premier vaccine adjuvant used in clinical programs for shingles and Tdap, and in global collaborations currently focused on adjuvanted vaccines for COVID-19, plague, seasonal influenza and universal influenza. For more information about our marketed products and development pipeline, visit . Forward-Looking Statements This press release contains "forward-looking" statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to a number of risks and uncertainties. All statements that are not historical facts are forward-looking statements. Forward-looking statements can generally be identified by the use of words such as "anticipate," "believe," "continue," "could," "estimate," "expect," "forecast," "intend," "will," "may," "plan," "project," "potential," "seek," "should," "think," "toward," "will," "would" and similar expressions, or the negatives thereof, or they may use future dates. Forward-looking statements made in this document include statements regarding our expected financial results and market share as of and for the year ended December 31, 2024, expectations regarding our future growth, extent and timing of market growth and market share beyond 2024, 2027 and 2030, the timing of IND filings, initiation and completion of clinical studies, expected timing for data readouts, and interaction with regulators. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including, the risk that actual demand for our products may differ from our expectations, risks relating to our ability to commercialize and supply HEPLISAV-B, risks related to the timing of completion and results of current clinical studies, risks related to the development and pre-clinical and clinical testing of vaccines containing CpG 1018 adjuvant, as well as other risks detailed in the "Risk Factors" section of our Quarterly Report on Form 10-Q for the three months ended June 30, 2024 and periodic filings made thereafter, as well as discussions of potential risks, uncertainties and other important factors in our other filings with the U.S. Securities and Exchange Commission. These forward-looking statements are made as of the date hereof, are qualified in their entirety by this cautionary statement and we undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Information on Dynavax's website at is not incorporated by reference in our current periodic reports with the SEC. For Investors/Media: Paul Cox [email protected] 510-665-0499 Nicole Arndt [email protected] 510-665-7264 SOURCE Dynavax Technologies

First BPZE1 clinical trial conducted in children Next generation pertussis vaccine induced broad immunity with a favorable safety pro > Trial confirms BPZE1 and Tdap can be safely co-administered WESTON, Fla.--(BUSINESS WIRE)-- iLiAD Biotechnologies, LLC (ILiAD) reported today that BPZE1, the most advanced next generation pertussis vaccine, demonstrated positive topline interim results in the SUPER (Stand Up to Pertussis) school-age trial conducted in 366 participants in the United Kingdom, Australia and Costa Rica. The SUPER trial is the first multi-center, placebo-controlled, randomized study of BPZE1 in healthy children 6 - 17 years of age to assess the immunological response and safety of a single intranasal dose of BPZE1 with and without co-administration of tetanus, diphtheria, and acellular pertussis (Tdap, Boostrix®). The primary immunogenicity objective of the trial is to demonstrate induction of broad pertussis mucosal secretory immunoglobulin A (S-IgA) immunity 29 days after vaccination with BPZE1 alone or with BPZE1 + Tdap. The primary safety objective is to assess reactogenicity through 7 days following vaccination with BPZE1 alone, BPZE1 + Tdap, or Tdap alone. A key secondary objective is to demonstrate non-interference of serum immunoglobulin G (IgG) responses against Tdap-containing antigens (diphtheria, tetanus, pertussis toxin [PT], filamentous hemagglutinin [FHA], pertactin [PRN]) at Day 29 after co-administration of BPZE1 with Tdap. Children intranasally vaccinated with BPZE1 alone and in combination with intramuscular administration of Tdap had 3.8-fold and 3.4-fold increases, respectively, from baseline levels of S-IgA against whole cell B. pertussis extract, while children vaccinated with Tdap alone had minimal increase (1.2-fold increase from baseline). In addition to induction of mucosal immunity, BPZE1 also induced broad systemic immunological antibody responses when given alone. Moreover, when given in combination with Tdap, BPZE1 induced systemic IgG responses equal to or greater than responses induced by Tdap alone. Further, co-administering BPZE1 with Tdap did not interfere with induction of tetanus or diphtheria antibody responses. Minimal reactogenicity was observed across all groups in this pediatric study, consistent with the favorable safety pro established in 5 adult clinical trials. Keith Rubin, M.D., ILiAD Chief Executive Officer and Founder, commented, "BPZE1 has once again demonstrated its unique ability to safely induce potent mucosal and systemic immunity. While similar findings were previously observed in 5 adult BPZE1 clinical trials, we now have substantial evidence that the same can be said of BPZE1's ability to safely induce potent immune responses against B. pertussis in children. This immunity and potential ability to prevent transmission may one day protect not only school-age children around the world, but also their vulnerable contacts, particularly infants. This trial also provides evidence that BPZE1 can be flexibly integrated into the current vaccination schedule. Our deepest gratitude to everyone who contributed to this study, especially the children and parents who made this important milestone possible." This is the first clinical trial in which BPZE1 has been studied specifically in subjects who received a diphtheria, tetanus, and acellular pertussis (DTaP) vaccine in infancy. Previous BPZE1 trials primarily evaluated BPZE1 in adults who received a first-generation whole cell pertussis (wP) vaccine as infants. wP vaccines are associated with greater side effects than DTaP, which has led to the replacement of wP with DTaP in most developed countries. “School-age children are a segment of the population who have experienced an escalating rate of pertussis disease and have become a vector for transmission to vulnerable infants,” said Stephanie Noviello, M.D. Chief Medical Officer at ILiAD. “We need a vaccine that can effectively stop the spread of pertussis. In this trial, BPZE1 demonstrated induction of mucosal immunity in children, which supports its potential to prevent the pervasive cycle of B. pertussis transmission.” About Pertussis Pertussis (whooping cough) is a life-threatening disease caused by the highly contagious respiratory bacterium Bordetella pertussis. According to U.S. Centers for Disease Control and Prevention, each year pertussis affects approximately 16 million people globally, accounting for nearly 200,000 deaths. Although estimated global vaccination coverage is 84%, current vaccines have failed to control epidemics. About BPZE1 BPZE1 is a next-generation live-attenuated pertussis vaccine designed to induce comprehensive and durable protection against B. pertussis infection (colonization) and disease (whooping cough). BPZE1 is being developed to block B. pertussis from colonizing the nasal passages of adults and children, to protect adults and children from whooping cough, and to potentially prevent transmission, including transmission to infants. While ILiAD is currently focused on developing a vaccine to directly protect adults and children and to indirectly protect vulnerable infants, future development aims to immunize neonates directly. BPZE1 was developed at the Institut Pasteur de Lille (France) in the lab of Camille Locht PhD and Nathalie Mielcarek PhD. About ILiAD Biotechnologies, LLC ILiAD Biotechnologies ( ) is a privately held, clinical stage biotechnology company dedicated to the prevention and treatment of human disease caused by Bordetella pertussis. The company is developing and acquiring key technologies, working with leading scientists to overcome the limitations of current vaccines, investigating the impact of B. pertussis in a range of human disease, and is focused on validating its proprietary vaccines in human clinical trials. “Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995. In addition to historical facts or statements of current, this press release may contain forward-looking statements. Forward-looking statements provide ILiAD’s current expectations or forecasts of future events. These may include statements regarding anticipated development of potential products, interpretation of clinical results, prospects for regulatory approval, outsourcing trends in the pharmaceutical industry, levels of industry research and development spending, rapid technological change, risks associated with acquisitions and investments, risks associated directly with BPZE technologies including but not limited to uncertainties of product development, and uncertainties of clinical development, dependence on third parties, competition, protection of patents and proprietary technology, potential for infringement and other statements regarding matters that are not historical fact. Some of these forward-looking statements may be identified by use of words in the statements such as “estimate,” “intend,” or other words and terms of similar meaning. Statements in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. ILiAD cautions investors not to place reliance on the forward-looking statements contained in this press release. These statements speak only as of the date of this release and ILiAD undertakes no obligations to update or review these statements, except as may be required by law.