Hepatitis B vaccine(GlaxoSmithKline Plc)

PreHevbrio (Hepatitis B Vaccine [Recombinant]) global net revenue increased 52% quarter-over-quarter from Q2 to Q3 2023 Continued execution across earlier-stage pipeline, including: Initiation of Phase 2b study of VBI-1901 in recurrent glioblastoma (GBM) patients Interim Phase 1 data announced for pan-coronavirus candidate, VBI-2901 Novel mRNA-launched eVLP platform technology announced CAMBRIDGE, Mass.--(BUSINESS WIRE)-- VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today provided a business update and announced financial results for the quarter ended September 30, 2023. "In Q3, we were focused on pipeline execution with continued revenue growth for PreHevbrio, meaningful data readouts and clinical advancements of our lead development candidates, and the announcement of a next-generation proprietary technology that blends the benefits of our eVLP technology with those of mRNA platforms,” said Jeff Baxter, VBI’s President and CEO. “Additionally, in this period of challenging financial markets for biotechnology companies, we are intensely focused on managing our operating expenses and capital to fuel sustainable growth and value for key stakeholders.” Recent Key Program Achievements and Projected Upcoming Milestones Hepatitis B (HBV) PreHevbrio [Hepatitis B Vaccine (Recombinant)] Global net product sales increased 52% from Q2 2023 with $1.1 million earned in Q3 2023 Net product sales are net of the provision for discounts, chargebacks, rebates, and fees – in the aggregate, these discounts reduced sales by $0.6 million in Q3 2023, from $1.7 million gross sales to $1.1 million net sales Quarter-over-quarter momentum continues to grow, with more than a 10% increase in total customer base in Q3 as compared to Q2 2023 Contracting network across multiple market segments also continues to see growth, including with retail partners, Integrated Delivery Networks (IDNs) and large hospital systems, multiple large military and federal facilities, prisons, and independent and public health clinics July 2023: Exclusive licensing deal with Brii Biosciences (Brii Bio) announced for the development and commercialization of PreHevbri in the Asia Pacific region, excluding Japan October 2023: Peer-reviewed publication of review of data from studies of PreHevbrio published in Expert Review of Vaccines Manuscript title: “PreHevbrio: the first approved 3-antigen hepatitis B vaccine” Q4 2023: New market launches expected in additional European Union countries through partnership with Valneva (under brand name PreHevbri®) VBI-2601 (BRII-179): HBV Immunotherapeutic Candidate July 2023: Announced exclusive global licensing agreement with Brii Bio for the development and commercialization of VBI-2601 This expanded partnership adds VBI-2601 to Brii Bio’s HBV portfolio, which, through a series of strategic investments and partnerships is among the most advanced in the chronic HBV field VBI will continue to share in the success of VBI-2601, with the potential to receive regulatory and commercial milestone payments, in addition to potential double-digit royalties on global sales of VBI-2601 September 2023: Brii Bio announced topline interim results of Phase 2 study evaluating VBI-2601 in combination with pegylated interferon-alpha (PEG–IFNα) in chronic HBV patients The combination treatment elicited improved hepatitis B S-antigen (HBsAg) loss and seroconversion vs. PEG–IFNα alone both at the end of treatment and after 12 weeks of follow up November 2023: In two late-breaking poster presentations at AASLD The Liver Meeting® 2023, Brii Bio announced new data from Phase 2 studies of VBI-2601 (BRII-179) highlighting progress towards achieving HBV functional cure: Direct evidence that BRII-179-induced functional antibody responses can contribute to increased and sustained HBsAg loss rate New insight utilizing BRII-179 to enrich patients with intrinsic humoral immune responses for higher HBsAg loss or HBV functional cure rates Glioblastoma (GBM) VBI-1901: Cancer Vaccine Immunotherapeutic Candidate September 2023: Announcement of first patients dosed in the randomized, controlled Phase 2b study of VBI-1901, an FDA Fast Track and Orphan Drug Designated cancer vaccine candidate, in recurrent GBM patients Around Year-End 2023: Expected initiation of VBI-1901 study arm, as part of Individualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT), a Phase 2 adaptive platform trial, in combination with Agenus Inc.’s anti-PD-1, balstilimab, in primary GBM patients H2 2024: Interim data analyses from Phase 2b study in recurrent GBM patients expected, subject to speed of patient enrollment COVID-19 & Coronaviruses VBI-2901: Multivalent Pan-Coronavirus Vaccine Candidate September 2023: Initial data from Phase 1 study of VBI-2901 reported – the first clinical data from a pan-coronavirus vaccine candidate VBI-2901 demonstrated vaccine benefit – reflected as boosting of and/or greater durability of antibody titer maintenance: All participants saw boosting and/or high neutralizing antibody responses against a panel of COVID-19 variants and two animal coronaviruses Participants with lower baseline antibody titers, reflecting a higher-risk population, saw the greatest boosting effect (5-14x strain-dependent boosting) Durability benefit observed regardless of baseline antibody levels, with only about 25% reduction in geometric mean titer (GMT) against the Wuhan strain after 5 months vs. peak responses – compared to an approximate 77% decline in GMT against the Wuhan strain vs. peak responses to a licensed mRNA vaccine [Gilboa M, 2022]1 Q1 2024: Additional durability and breadth data from the Phase 1 study expected Funds from existing partners, including the Canadian government and the Coalition for Epidemic Preparedness Innovations (CEPI) are available to fund the next phase of clinical development Novel mRNA-Launched eVLP (MLE) Technology Platform October 2023: Development of a novel mRNA-launched eVLP (MLE) technology platform announced, supported by preclinical data that have demonstrated significant immunologic and manufacturing benefits MLE technology enables the manufacture of particulate vaccines, capable of driving polyfunctional B-cell and T-cell activation, on accelerated timelines, similar to other mRNA vaccine production timelines New platform has the potential to be leveraged across infectious disease, cancer, and allergic and autoimmune disease indications Third Quarter 2023 Financial Results Cash Position: VBI ended the third quarter of 2023 with $35.5 million in cash as compared with $62.6 million in cash as of December 31, 2022. Revenues, net: Revenues, net for the third quarter of 2023 were $6.6 million as compared to $0.3 million for the same period in 2022. The revenue increase was a result of an increase in product sales of PreHevbrio in the U.S. and of PreHevbri to our partner, Valneva, in Europe, in addition to the license revenue and R&D services revenue associated with the HBV license agreement, expanded in July 2023, with Brii Bio. Cost of Revenues: Cost of revenues was $2.5 million in the third quarter of 2023 as compared to $2.7 million in the third quarter of 2022. The decrease in the cost of revenues was due to increased product sales, offset by lower direct labor costs as a result of the recent organization changes that reduced our internal workforce. Research and Development (R&D): R&D expenses for the third quarter of 2023 were $1.5 million as compared to $5.0 million for the third quarter of 2022. R&D expenses were offset by $2.7 million in the third quarter of 2023 and $2.4 million in the third quarter of 2022 due to government grants and funding arrangements. Sales, General, and Administrative (SG&A): SG&A expenses for the third quarter of 2023 were $9.0 million as compared to $14.2 million for the same period in 2022. The decrease in SG&A expenses was mainly a result of the recent organizational changes that reduced our internal workforce, as announced in April 2023, the redefined deployment strategy of our U.S. commercial field force, and a reduction in activity-based commercial expenses related to PreHevbrio. Net Cash Used in Operating Activities: Net cash used in operating activities for the nine months ended September 30, 2023, was $48.8 million compared to $54.6 million for the same period in 2022. The decrease in cash outflows is largely a result of non-cash reconciling items, mainly impairment charges and unrealized foreign exchange loss, and the change in operating working capital, most notably in inventory, other current assets, accounts payable, deferred revenues, and other current liabilities. As announced on April 4, 2023, VBI implemented cost saving measures that are expected to reduce operating expenses from normal business in the second half of 2023 by 30-35% compared to the second half of 2022. Net Loss and Net Loss Per Share: Net loss and net loss per share for the third quarter of 2023 were $20.4 million and $1.01, respectively, compared to a net loss and net loss per share of $25.2 million and $2.93 for the third quarter of 2022, respectively. Net Loss, Excluding Impairment Charges and Foreign Exchange Loss, and Net Loss Per Share, Excluding Impairment Charges and Foreign Exchange Loss: Net loss, excluding impairment charges and foreign exchange loss, and net loss per share, excluding impairment charges and foreign exchange loss, for the third quarter of 2023 were $8.0 million and $0.38, respectively, compared to $22.5 million and $2.62 for the third quarter of 2022, respectively. See “Non-GAAP Financial Information” below for additional information regarding this non-GAAP financial measure, and “GAAP to Non-GAAP Reconciliation” for a reconciliation of this non-GAAP financial measure to net loss and net loss per share. Impairment charges and foreign exchange loss for the third quarter of 2023 were $3.6 million and $8.8 million, respectively, as compared to none and $2.7 million for the third quarter of 2022. Certain intercompany loans between the Company and its subsidiaries are denominated in a currency other than the functional currency of each entity. The primary driver of the increase in foreign exchange loss was the impact of the relative strengthening of the U.S. and Canadian Dollars against the New Israeli Shekel upon translation of these intercompany loans. Use of Non-GAAP Financial Measures Net Loss, Excluding Impairment Charges and Foreign Exchange Loss, and Net Loss Per Share, Excluding Impairment Charges and Foreign Exchange Loss, are non-GAAP financial measures and are defined as Net Loss and Net Loss Per Share excluding the non-cash impairment charges and foreign exchange loss in both calculations. Net Loss, Excluding Impairment Charges and Foreign Exchange Loss, and Net Loss Per Share, Excluding Impairment Charges and Foreign Exchange Loss, are not intended to replace Net Loss or Net Loss Per Share or other measures of financial performance reported in accordance with generally accepted accounting principles (GAAP). VBI’s management believes that the presentation of Net Loss, Excluding Impairment Charges and Foreign Exchange Loss, and Net Loss Per Share, Excluding Impairment Charges and Foreign Exchange Loss, are useful to investors because management does not consider foreign exchange loss, which is primarily driven by changes in exchange rates related to certain intercompany loans, and non-cash impairment charges, both of which are non-recurring items, when evaluating VBI’s operating performance. Non-GAAP financial measures are meant to supplement, and to be viewed in conjunction with, GAAP financial results. The presentation of these non-GAAP financial measures should not be considered in isolation or as a substitute for comparable GAAP financial measures and should be read only in conjunction with the Company’s financial statements prepared in accordance with GAAP. Reconciliations of the Company’s non-GAAP measures are included below. The following represents a reconciliation of Net Loss to Net Loss, Excluding Impairment Charges and Foreign Exchange Loss, and Net Loss Per Share to Net Loss Per Share, Excluding Impairment Charges and Foreign Exchange Loss. See “Non-GAAP Financial Information” below for additional information regarding this non-GAAP financial measure, and “GAAP to Non-GAAP Reconciliation” for a reconciliation of this non-GAAP financial measure to net loss and net loss per share. Three Months Ended September 30 2023 2022 (Unaudited) (In 000’s except share and per share amounts) Net Loss $ (20,444) $ (25,209) Impairment charges 3,600 - Foreign exchange loss 8,832 2,693 Net loss, excluding impairment charges and foreign exchange loss $ (8,012) $ (22,516) Weighted-average number of shares 21,166,818 8,608,539 Net loss per share, excluding impairment charges and foreign exchange loss $ (0.38) $ (2.62) About PreHevbrio [Hepatitis B Vaccine (Recombinant)] PreHevbrio is the only 3-antigen hepatitis B vaccine, comprised of the three surface antigens of the hepatitis B virus – Pre-S1, Pre-S2, and S. It is approved for use in the U.S., European Union/European Economic Area, United Kingdom, Canada, and Israel. The brand names for this vaccine are: PreHevbrio® (US/Canada), PreHevbri® (EU/EEA/UK), and Sci-B-Vac® (Israel). Please visit for U.S. Important Safety Information for PreHevbrio [Hepatitis B Vaccine (Recombinant)], or please see U.S. Full Prescribing Information. U.S. Indication PreHevbrio is indicated for prevention of infection caused by all known subtypes of hepatitis B virus. PreHevbrio is approved for use in adults 18 years of age and older. U.S. Important Safety Information (ISI) Do not administer PreHevbrio to individuals with a history of severe allergic reaction (e.g. anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of PreHevbrio. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of PreHevbrio. Immunocompromised persons, including those on immunosuppressant therapy, may have a diminished immune response to PreHevbrio. PreHevbrio may not prevent hepatitis B infection, which has a long incubation period, in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration. The most common side effects (> 10%) in adults age 18-44, adults age 45-64, and adults age 65+ were pain and tenderness at the injection site, myalgia, fatigue, and headache. There is a pregnancy exposure registry that monitors pregnancy outcomes in women who received PreHevbrio during pregnancy. Women who receive PreHevbrio during pregnancy are encouraged to contact 1-888-421-8808 (toll-free). To report SUSPECTED ADVERSE REACTIONS, contact VBI Vaccines at 1-888-421-8808 (toll-free) or VAERS at 1-800-822-7967 or . Please see Full Prescribing Information. About VBI Vaccines Inc. VBI Vaccines Inc. (“VBI”) is a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease. Through its innovative approach to virus-like particles (“VLPs”), including a proprietary enveloped VLP (“eVLP”) platform technology and a proprietary mRNA-launched eVLP (“MLE”) platform technology, VBI develops vaccine candidates that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system. VBI is committed to targeting and overcoming significant infectious diseases, including hepatitis B, coronaviruses, and cytomegalovirus (CMV), as well as aggressive cancers including glioblastoma (GBM). VBI is headquartered in Cambridge, Massachusetts, with research operations in Ottawa, Canada, and a research and manufacturing site in Rehovot, Israel. Website Home: News and Resources: Investors: References Gilboa, Mayan, Regev-Yochay, Gili, Mandelboim, Michael et al. Durability of Immune Response After COVID-19 Booster Vaccination and Association With COVID-19 Omicron Infection. JAMA Network Open. September 2022 Cautionary Statement on Forward-looking Information Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are forward-looking information within the meaning of Canadian securities laws (collectively, “forward-looking statements”). The Company cautions that such forward-looking statements involve risks and uncertainties that may materially affect the Company’s results of operations. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including but not limited to, the impact of general economic, market, industry or political conditions in the United States or internationally; the impact of the COVID-19 endemic and the continuing effects of the COVID-19 endemic on our clinical studies, manufacturing, business plan, and the global economy; the ability to successfully manufacture and commercialize PreHevbrio/PreHevbri; the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of pipeline candidates and the commercialization of PreHevbrio/PreHevbri; the ability to obtain appropriate or necessary regulatory approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; the Company’s ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; our ability to regain and maintain compliance with the Nasdaq Capital Market’s listing standards; and the ability to secure and enforce legal rights related to the Company’s products. A discussion of these and other factors, including risks and uncertainties with respect to the Company, is set forth in the Company’s filings with the SEC and the Canadian securities authorities, including its Annual Report on Form 10-K filed with the SEC on March 13, 2023, and filed with the Canadian security authorities at sedar.com on March 13, 2023, as may be supplemented or amended by the Company’s Quarterly Reports on Form 10-Q. Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by this cautionary statement. All such forward-looking statements made herein are based on our current expectations and we undertake no duty or obligation to update or revise any forward-looking statements for any reason, except as required by law. VBI Vaccines Inc. and Subsidiaries Selected Unaudited Condensed Consolidated Balance Sheet (In Thousands) September 30, 2023 December 31, 2022 (Unaudited) Assets Cash $ 35,454 $ 62,629 Accounts receivable, net 353 94 Inventory, net 7,540 6,599 Prepaid expenses and other current assets 6,800 8,368 Total current assets 50,147 77,690 Property and equipment, net 9,423 12,253 Intangible assets, net 35,603 58,345 Goodwill 2,121 2,127 Other non-current assets 3,490 4,671 Total Assets $ 100,784 $ 155,086 Liabilities and stockholders’ equity Accounts payable $ 7,008 $ 12,973 Current portion of long-term debt 50,299 - Other current liabilities 19,887 23,969 Total current liabilities 77,194 36,942 Total non-current liabilities 3,704 53,981 Total liabilities 80,898 90,923 Total stockholders' equity 19,886 64,163 Total liabilities and stockholders' equity $ 100,784 $ 155,086 VBI Vaccines Inc. and Subsidiaries Condensed Consolidated Statement of Operations and Comprehensive Loss (In Thousands Except Share and Per Share Amounts) Three Months Ended September 30 Nine Months Ended September 30 2023 2022 2023 2022 (Unaudited) Revenues, net $ 6,624 $ 317 $ 7,829 $ 789 Operating expenses Cost of revenue 2,525 2,672 9,564 7,948 Research and development 1,532 4,983 7,975 12,988 Sales, general and administrative 9,036 14,220 33,237 40,234 Impairment charges 3,600 - 23,600 - Total operating expenses 16,693 21,875 74,376 61,170 Loss from operations (10,069) (21,558) (66,547) (60,381) Interest expense, net (1,543) (958) (4,680) (2,799) Foreign exchange loss (8,832) (2,693) (21,596) (28,982) Loss before income taxes (20,444) (25,209) (92,823) (92,162) Income tax expense - - - - Net Loss $ (20,444) $ (25,209) $ (92,823) $ (92,162) Deemed dividend on certain warrants (862) (862) Net Loss Available to Common Stockholders $ (21,306) $ (25,209) $ (93,685) $ (92,162) Basic and diluted net loss per share (1.01) (2.93) (7.30) (10.71) Weighted-average number of shares used to compute basic and diluted net loss per share 21,166,818 8,608,539 12,840,633 8,608,530 Other comprehensive income (loss) - currency translation adjustments 7,753 (494) 21,022 23,845 Comprehensive Loss $ (12,691) $ (25,703) $ (71,801) $ (68,317)

Generated quarterly HEPLISAV-B® vaccine net product revenue of $62.3 million, a 66% year-over-year increase Raising full year HEPLISAV-B net product revenue guidance to $210 - $220 million, compared to prior range of $200 - $215 million Cash and investments increased to $720 million at quarter end; expects positive free cash flow for full year Conference call today at 4:30 p.m. ET/1:30 p.m. PT EMERYVILLE, Calif., Nov. 2, 2023 /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 September 30, 2023. "We're pleased to report yet another record quarter of HEPLISAV-B revenue driven by continued market share growth and overall expansion of the adult hepatitis B market, demonstrating progress toward our goal of establishing HEPLISAV-B as the leading adult hepatitis B vaccine in the U.S., a market opportunity we believe will continue to expand to over $800 million by 2027," said Ryan Spencer, Chief Executive Officer of Dynavax. "In addition to HEPLISAV-B, we are focused on advancing our pipeline of innovative vaccine candidates, pursuing strategic opportunities to accelerate our growth, and continuing to drive strong financial performance, reflecting the solid foundation we've established for sustained success." 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 achieved net product revenue of $62.3 million for the third quarter of 2023, an increase of 66% compared to $37.5 million for the third quarter of 2022. HEPLISAV-B total market share in the U.S. increased to approximately 41%, compared to approximately 32% at the end of the third quarter of 2022. HEPLISAV-B market share in the Integrated Delivery Networks (IDNs) and Large Clinics segment increased to approximately 54% at the end of the third quarter of 2023, compared to approximately 43% for the same quarter in 2022. HEPLISAV-B market share in the retail pharmacy segment increased to approximately 53% at the end of the third quarter of 2023, compared to 43% for the same quarter in 2022. A supplemental Biologic License Application (sBLA) for HEPLISAV-B vaccination of adults on hemodialysis is currently under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) action date expected on May 13, 2024. 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. Shingles vaccine program: Z-1018 is an investigational vaccine candidate being developed for the prevention of shingles in adults aged 50 and older. Dynavax recently received Type B meeting feedback from the FDA on the Z-1018 clinical development plan and expects to submit an Investigational New Drug Application (IND) to the FDA to support the initiation of a Phase 1/2 trial of Z-1018 in the first half of 2024. Tdap vaccine program: Tdap-1018 is an investigational vaccine candidate intended for active booster immunization against tetanus, diphtheria, and pertussis (Tdap). Dynavax plans to submit an Investigational New Drug Application (IND) to the FDA to support the initiation of a Phase 2 human challenge study of Tdap-1018 in mid-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 and the U.S. Department of Defense recently executed a contract modification to support advancement of the plague vaccine candidate into a nonhuman primate challenge study, which was initiated in August, with the agreement now totaling $33.7 million through 2025. Dosing has been completed in a randomized, active-controlled Phase 2 clinical trial evaluating immunogenicity, safety, and tolerability, with top line data anticipated in 2024. THIRD QUARTER 2023 FINANCIAL HIGHLIGHTS Total Revenues and Net Product Revenue. HEPLISAV-B vaccine net product revenue was $62.3 million for the third quarter of 2023, compared to $37.5 million for the third quarter of 2022, representing year-over-year growth of 66%. The increase was primarily due to higher sales volume driven by both continued improvement in market share and higher utilization of adult hepatitis B vaccines related to the ACIP universal recommendation. Other revenue was $7.2 million for the third quarter of 2023, compared to $3.9 million in the same period of 2022. Other revenue primarily includes revenue from our plague vaccine agreement with the U.S. Department of Defense. The increase was primarily driven by the advancement into a nonhuman primate challenge study. No CpG 1018 adjuvant product revenue was recorded in the third quarter of 2023, compared to $126.3 million in the third quarter of 2022, due to completion of all obligations and product delivery under the Company's CpG 1018 adjuvant COVID-19 collaboration agreements as of December 31, 2022. Total revenues for the third quarter of 2023 were $69.5 million, compared to $167.7 million for the third quarter of 2022. Cost of Sales - Product. Cost of sales - product for HEPLISAV-B in the third quarter of 2023 increased to $13.2 million, compared to $11.5 million for the third quarter of 2022. The increase was primarily due to higher sales volume driven by continued improvement in HEPLISAV-B market share, offset by lower per-unit manufacturing costs as the result of previous process improvements. Total cost of sales – product for the third quarter of 2023 decreased to $13.2 million, compared to $61.3 million in the third quarter of 2022. The decrease is primarily due to no CpG 1018 adjuvant cost of sales - product for the third quarter of 2023 as a result of completing all obligations and product delivery under the prior CpG 1018 adjuvant collaboration agreements as of December 31, 2022. Research and Development Expenses (R&D). R&D expenses for the third quarter of 2023 increased to $14.1 million, compared to $13.0 million for the third quarter of 2022. The increase was primarily driven by continued investments in advancing our clinical and preclinical development programs and collaborations. Selling, General, and Administrative Expenses (SG&A). SG&A expenses for the third quarter of 2023 increased to $38.1 million, compared to $32.0 million for the third quarter of 2022. The increase was primarily driven by higher compensation and related personnel costs and an overall increase in targeted commercial and marketing efforts designed to increase HEPLISAV-B market share and maximize the opportunities presented by the ACIP's universal recommendation. Net income. GAAP net income was $14.3 million, or $0.11 per share (basic) and $0.10 per share (diluted) in the third quarter of 2023, compared to GAAP net income of $63.8 million, or $0.50 per share (basic) and $0.43 per share (diluted) in the third quarter of 2022. Cash and Marketable Securities. Cash, cash equivalents and marketable securities were $720.4 million as of September 30, 2023. 2023 FINANCIAL GUIDANCE Full year 2023 financial guidance has been revised to consist of the following expectations: HEPLISAV-B net product revenue between approximately $210 - $220 million, compared to the prior range of approximately $200 - $215 million. Research and development expenses between approximately $50 - $60 million, compared to the prior range of approximately $55 - $70 million. Selling, general and administrative expenses between approximately $145 - $155 million, compared to the prior range of approximately $135 - $155 million. Conference Call and Webcast Information Dynavax will host a conference call and live audio webcast on Thursday, November 2, 2023, 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 multiple adjuvanted COVID-19 vaccines. Dynavax is advancing CpG 1018 adjuvant as a premier vaccine adjuvant with adjuvanted vaccine clinical programs for shingles and Tdap, and through 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 and follow Dynavax on LinkedIn. 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," "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 financial guidance, our plans and strategies, the development and potential approval of vaccines containing CpG 1018 adjuvant by us or by our collaborators, the timing of IND filings, the timing of initiation and completion of clinical studies and the publication of results. 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 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, whether use of CpG 1018 adjuvant will prove to be beneficial in these vaccines, as well as other risks detailed in the "Risk Factors" section of our Annual Report on Form 10-Q for the quarter ended September 30, 2023 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