SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
(Exact name of Registrant as Specified in Its Charter)
(State or Other Jurisdiction
(Commission File Number)
(Address of Principal Executive Offices)
Registrant’s Telephone Number, Including Area Code:
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On January 9, 2023, Dynavax Technologies Corporation ("Dynavax") issued a press release announcing its preliminary unaudited fourth quarter and full year 2022 financial highlights. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K, and is incorporated herein by reference.
The preliminary selected financial results included in the press release are based upon estimates and information available as of the date of the press release. Accordingly, undue reliance should not be placed on these preliminary estimates. In addition, the Company has not yet completed its financial close process for the quarter and year ended December 31, 2022, therefore the estimates included in the press release regarding net product revenue and cash and cash equivalents, and marketable securities are preliminary, unaudited and are subject to change upon completion of the Company’s financial statement closing procedures and the audit of the Company’s consolidated financial statements.
Item 7.01 Regulation FD Disclosure.
The press release issued by the Company on January 9, 2023, and attached as Exhibit 99.1 to this current report also reported phase 1 shingles topline results.
The Company has posted a presentation (the “Presentation”) to its website at www.dynavax.com, in the “Events & Presentations” subsection of the “News & Events” tab. A copy of the Presentation is attached as Exhibit 99.2 to this current report and is incorporated herein by reference.
All of the information furnished in this Form 8-K, including the accompanying Exhibits 99.1 and 99.2, shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in this current report and in the accompanying exhibit shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by Dynavax, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits. The following exhibit is furnished herewith:
Cover Page Interactive Data File (embedded within the Inline XBRL document)
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
Dynavax Technologies Corporation
January 9, 2023
/s/ Kelly MacDonald
Dynavax Announces Preliminary Unaudited Fourth Quarter and Full Year 2022 Financial Highlights and Phase 1 Shingles Topline Results
EMERYVILLE, CA – January 9, 2023 – Dynavax Technologies Corporation (Nasdaq: DVAX), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative vaccines, today announced preliminary, unaudited financial highlights for the fourth quarter and full year ending December 31, 2022 and Phase 1 shingles topline results.
“We are pleased with the relentless execution of our strategy throughout 2022, delivering transformative progress across our commercial and development portfolio including revenue at the top end of our guidance, achievement of all of our stated clinical milestones and the strengthening of our balance sheet,” said Ryan Spencer, Chief Executive Officer of Dynavax. “In 2023, we anticipate building on the strong foundation laid in 2022, with continued product revenue growth for HEPLISAV-B, advancement of our clinical development pipeline leveraging our versatile CpG 1018 adjuvant technology and execution of our corporate development objectives to help drive long-term value.”
2022 Preliminary Unaudited Commercial and Financial Highlights:
The preliminary selected financial results contained herein are unaudited, subject to adjustment, and provided as an estimate in advance of the Company’s announcement of complete financial results for the three and twelve months ended December 31, 2022.
Phase 1 Topline Results from Shingles Program
The Phase 1 clinical trial (DV2-ZOS-01) was designed to evaluate an investigational shingles vaccine Z-1018, utilizing different regimens of CpG 1018 adjuvant, with or without aluminum hydroxide (alum). The trial compared Z-1018 arms versus the active comparator Shingrix®. The Company reported the following topline results, assessed at Week 12, and plans to submit an abstract for presentation at an upcoming medical meeting in the first half of 2023.
“With these promising data, we have a better understanding of the potential for a CpG 1018 adjuvanted shingles vaccine to reduce post-injection reactions to improve patients’ experience compared with the currently commercialized shingles vaccine,” said Dr. Robert Janssen, Chief Medical Officer of Dynavax. “With the high vaccine response rate, and in comparison with immunologic and efficacy data from previous shingles vaccine studies, we believe our vaccine candidate has the potential to be highly efficacious.”
Based on these initial data, the Company intends to advance its shingles vaccine candidate with CpG 1018 adjuvant into a Phase 1-2 study in early 2024 to expand on these results and to evaluate various dose levels of Dynavax-manufactured gE protein.
About DV2-ZOS-01 Clinical Trial
DV2-ZOS-01 is a randomized, active-controlled, dose-escalation, multi-center Phase 1 clinical trial to evaluate the safety, tolerability, and immunogenicity of investigational herpes zoster (shingles) vaccine utilizing a commercially available gE plus CpG 1018 adjuvant (Z-1018) with and without alum compared to Shingrix® in approximately 150 healthy volunteers between the ages of 50 and 69 years of age.
For additional information about this trial, please visit www.clinicaltrials.gov using the identifier NCT05245838.
Shingrix® is a registered trademark of GlaxoSmithKline, PLC.
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, please visit the following website at https://www.heplisavbhcp.com, and click the “Prescribing Information” link in the “Important Safety Information” section.
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%).
Dynavax (Nasdaq: DVAX) 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. and the European Union 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 through global research collaborations and partnerships. Current collaborations are focused on adjuvanted vaccines for COVID-19, seasonal influenza, universal influenza, plague, shingles and Tdap. For more information, visit www.dynavax.com and follow the company on LinkedIn.
Forward Looking Statements
This press release contains "forward-looking" statements, including statements regarding expected or anticipated financial performance, including market share, revenue and profitability, potential U.S. market for hepatitis vaccines, establishing CpG 1018 as a leading adjuvant, future sales of CpG 1018 or HEPLISAV-B or other product candidates, anticipated timing and progress of the DV2-ZOS-01 clinical trial and related data analysis, data preparation and publication, the timing of a Phase 1/2 trial for the shingles vaccine candidate or other candidates. 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 HEPLISAV-B may not become the standard of care adult hepatitis B vaccine in the U.S., risks related to whether and when prescribers and other key decision-makers at potential purchasing entities will make the decision to switch to HEPLISAV-B, and the timing and quantity of actual purchases, risks related to the timing and impact of the ACIP universal hepatitis B recommendation, risks related to the timing of completion and results of current clinical studies conducted by us or our collaborators, risks related to the development and pre-clinical and clinical testing of vaccines containing CpG 1018 adjuvant, and whether use of CpG 1018 adjuvant will prove to be beneficial in these vaccine candidates, risks related to whether, risks related to the use of contract manufacturers to timely supply CpG 1018 adjuvant and financial commitments made to them, as well as other risks detailed in the "Risk Factors" and “Management’s Discussion of Financial Condition and Results of Operations” sections of our Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2022 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. We undertake no obligation to revise or
update information herein to reflect events or circumstances in the future, even if new information becomes available.
Nicole Arndt, Investor Relations
Derek Cole, President
Investor Relations Advisory Solutions
Developing and Commercializing Innovative Vaccines Using Proven, Innovative Adjuvant Technology to Help Protect the World Against Infectious Diseases January 2023 Nasdaq: DVAX Exhibit 99.2
Forward-Looking Statements Statements contained in this presentation regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements about the potential for HEPLISAV-B to become the market leader and standard of care in the U.S., potential market opportunity for HEPLISAV-B in the U.S., Germany and other countries in total and by segment, possible timing and impact of ACIP recommendations, timing of our clinical trial completion and data readouts, potential markets and market size for each of our products or product candidates including our shingles and Tdap candidates, catalysts for our business and their anticipated effects, development and commercialization of a vaccine for COVID-19 by one or more of our collaborators, our development and commercialization of an improved pertussis and shingles vaccine and other vaccines using our CpG 1018® adjuvant, establishing CpG 1018 as a leading adjuvant platform, potential for CpG 1018 adjuvant to speed up protection in an improved plague vaccine and future revenue potential for CpG 1018 adjuvant. These forward-looking statements are based upon management’s current expectations, are subject to known and unknown risks and uncertainties, and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, including, without limitation, risks related to the continuing impact of COVID-19 on vaccine utilization and sales, including for HEPLISAV-B; risks related to the potential adverse effects of the coronavirus pandemic on our ability to access customers and on customer decision making, adoption and implementation; risks related to Dynavax’s ability to successfully commercialize HEPLISAV-B, which among other things will require Dynavax to successfully negotiate and enter into contracts with wholesalers, distributors, group purchasing organizations, and other parties, and maintain those contractual relationships, maintain and build its commercial infrastructure, and access prescribers and other key health care providers to discuss HEPLISAV-B; risks related to market adoption and competing products; risks related to whether payors will cover and provide timely and adequate reimbursement for HEPLISAV-B; risks related to the completion, timing of completion and results of post-marketing clinical trials of HEPLISAV-B, trials for other product candidates of ours or of our collaborators; risks related to development and commercialization of HEPLISAV-B in Europe and other countries; and risks associated with the development and commercialization of vaccines in the U.S. and outside the U.S., including vaccines for COVID-19, flu, shingles and pertussis. These and other risks and uncertainties are described in Dynavax’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, or any subsequent periodic filing made by us, under the heading “Risk Factors”. Dynavax undertakes no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. © Copyright DYNAVAX 2023
Versatile proprietary adjuvant technology Commercial vaccine with continued growth potential and significant addressable market Differentiated vaccine development pipeline targeting large indications with unmet need Fully-integrated infrastructure supporting U.S. commercialization & global manufacturing Strong financial profile Dynavax at a Glance A commercial-stage biopharmaceutical company committed to developing and commercializing novel vaccines to help protect the world against infectious diseases by utilizing proven, innovative adjuvant technology. © Copyright DYNAVAX 2023
Dynavax Core Strategic Priorities © Copyright DYNAVAX 2023 Drive Growth in Advance Differentiated Vaccine Pipeline Identify Strategic Opportunities to Accelerate Growth Increase market share to become the market leader by 2027 Maximize total addressable market based on the ACIP Universal Recommendation Foundational commercial asset to support company growth and pipeline development Deliver on our innovative and diversified pipeline leveraging CpG 1018® adjuvant with proven antigens Build adult vaccine portfolio of best-in-class products Advance innovative pre-clinical and discovery efforts leveraging collaborations Continue disciplined allocation of capital aligned with corporate strategy to deliver long-term value through internal and external innovation Pursue external opportunities to further leverage our U.S. commercial vaccine capabilities, prioritizing first or best-in-class assets
Executing on Our Strategy: FY-2022 Preliminary* Unaudited Financial & Pipeline Highlights Preliminary* FY-2022 Financial Results © Copyright DYNAVAX 2023 Tdap Phase 1 completed; positive data presented in October 2022 Shingles Phase 1 initiated and completed; positive topline results reported in January 2023 Plague Phase 2 trial initiated in August 2022 (fully funded by the Department of Defense) Pipeline Execution HEPLISAV-B® ~104% year-over-year topline growth with ~36% in total market share exiting 2022 ~$126 million in preliminary* FY-2022 net product revenue CpG 1018® Adjuvant supply business generated from five COVID-19 pandemic commercial supply agreements~$588 million in preliminary* FY-2022 net product revenue Strengthened Financial Profile~$624 million in preliminary* cash and cash equivalents, and marketable securities as of December 31, 2022 *Preliminary selected financial results contained herein are unaudited, subject to adjustment, and provided as an estimate in advance of the Company’s announcement of complete financial results for the three and twelve months ended December 31, 2022. These estimates represent management's expectations as of the date of posting.
CpG 1018® Adjuvant: Well-defined MOA and Clinical Profile Clinically Proven Profile Faster and consistently higher rates of protection in HEPLISAV-B, including in the elderly and populations less responsive to other vaccines Favorable tolerability profile Well-established safety, immunogenicity and efficacy profile as demonstrated in clinical trials (including multiple COVID-19) and commercial use (HEPLISAV-B®) Mechanism of Action CpG 1018 adjuvant is a synthetic form of DNA that mimics bacterial and viral DNA from infection TLR9 expressed primarily by plasmacytoid dendritic cells Elicits a T Helper (Th1) polarized CD4 T-cell response and increases antibody production Proprietary CpG 1018 adjuvant selectively and optimally activates TLR9 – an important toll-like receptor that elicits the body’s innate immune response when invading pathogens are introduced. © Copyright DYNAVAX 2023
A Broad Vaccine Platform With High Potential Our proprietary CpG 1018 adjuvant is being used to support worldwide vaccine development for infectious diseases which take an increasing toll on public health CpG 1018 adjuvant powers our FDA approved vaccine Shingles Tdap (pertussis) Pre-clinical Plague COVID-19 Hepatitis B COVID-19 CpG 1018 Adjuvant Supply Business Commercial Product Vaccine Development CpG 1018 adjuvant © Copyright DYNAVAX 2023
Diversified Pipeline Leveraging CpG 1018 Adjuvant © Copyright DYNAVAX 2023 U.S. Department of Defense Wholly owned by Dynavax Serum Institute of India US, EU and private market commercial rights owned by Dynavax Wholly owned by Dynavax Commercial Products Hepatitis B PRE-CLINICAL PHASE 1 PHASE 2 PHASE 3 COMMERCIAL PARTNER 1, 2 Vaccine Development Shingles COVID-19 CpG 1018 Adjuvant Supply Agreements* (partner-developed products) Plague Pertussis-Tdap 1 Approved: U.S. commercial launch Q1-2018; EU commercial launch Q2-2022.2 Commercialization agreement with Bavarian Nordic for the marketing and distribution of HEPLISAV-B in Germany.*The information provided in this section was last updated January 6, 2023; please visit partner websites for more information. Product Developer: BioFarma, Biological E, Clover Biopharmaceuticals, Medigen and Valneva
Commercial Product © Copyright DYNAVAX 2023 9 |
There is No Cure for Hepatitis B, Prevention is Essential Hepatitis B is an incurable liver infection caused by the hepatitis B virus transmitted by bodily fluids. When the virus attacks the liver, the resulting health complications can be lifelong or even deadly. © Copyright DYNAVAX 2023 1 out of 3 people have been infected with hep B (2 billion people) ~1.5 million people become newly infected each year ~300 million more infectious than HIV ~80% of people are unaware of their infection, increasing risk of unknowingly spreading it to others 30-59 years age range where new infections are highest 7 days virus can survive outside the body on surfaces people living with hepatitis B Globally1 100x Hepatitis B is Hepatitis B 1. Source: https://www.hepb.org/what-is-hepatitis-b/what-is-hepb/facts-and-figures/
HEPLISAV-B Clinical Outcomes Higher and faster rates of protection HEPLISAV-B provided significantly higher rates of protection than Engerix-B at every time point in clinical trials HEPLISAV-B provided significantly higher rates of protection in diabetics and other known hypo-responsive populations Fewer doses HEPLISAV-B is designed to protect with only 2 doses in 1 month compared to Engerix-B 3 doses in 6 months Favorable safety profile Across clinical trials in nearly 10,000 participants Weeks Primary Endpoint Results: Study 2 per protocol population (ages 40-70)1 Injections Primary endpoint Primary endpoint (N=1,482) HEPLISAV-B Engerix-B 1. Dynavax Technologies Corporation. FDA Advisory Committee Briefing Document: HEPLISAV-B (Hepatitis B Vaccine [Recombinant], Adjuvanted). Presented at: Meeting of the Vaccines and Related Biological Products Advisory Committee; July 28, 2017; Silver Spring, MD. © Copyright DYNAVAX 2023 Hepatitis B
Hepatitis B Market Opportunity © Copyright DYNAVAX 2023 Millions of Adults 209M 88M 73M 133M *Adults eligible for influenza vaccines calculated from population aged 18+ in 2022; adults eligible for shingles vaccines calculated using adults turning 50 years old in 2022, adults aged >50 who are unvaccinated based on CDC coverage rates, and immunocompromised adults aged 19-49; adults eligible for pneumonia vaccines included adults aged 65+ and at-risk adults aged 18-64 excluding smokers, patients with chronic heart disease, and patients who are immunocompromised; adults eligible for hepatitis B vaccination calculated using US census data published in 2018, CDC coverage data, and risk factor analyses. Approximate Number of Adults Recommended for Vaccination in 2022 Hep A/B Combo, Adult Hep B Monovalent Dialysis* ACIP universal recommendation has increased the number of eligible patients by ~100M people ACIP broadens and simplifies Hep B vaccine recommendations Dialysis-specific* dosing regimen data Improved compliance with two-dose advantage Targeted commercial investment driving growth in prioritized segments Projected Hepatitis-B Market: Hepatitis B 2022 U.S. Market 2027 Projected U.S. Market Hepatitis B Vaccination Now Has The Second Highest Addressable Population Based on 2022 U.S. Hepatitis B vaccines market, adjusted for company estimates regarding HEPLISAV-B dosing regimen and pricing *The 4-dose regimen for the dialysis population is not currently approved regimen. Safety and effectiveness have not been established in patients on hemodialysis. U.S. Adult Hepatitis B Vaccine Market Opportunity Projected to Double by 2027
Integrated Delivery Networks (IDN) and Retail are the Largest Growth Segments © Copyright DYNAVAX 2023 HEPLISAV-B is the Market Leader in IDN/Large Clinics – A Segment that will Drive Meaningful Growth from the ACIP Universal Recommendation 2027 Projected Market Size $800M2 IDN/ Large Clinics4 “Field Targeted” 30% Small Clinics/Ind. 27% IDN/ Large Clinics4 “Field Targeted” 32% Retail 14% Retail 27% Other 18% Dialysis3 11% 2022 Market Size $375M1 Small Clinics/Ind. 23% Other 12% Dialysis3 6% Hepatitis B Source: Internal Data and company estimates. Not independently verified. 1 Based on 2022 U.S. adult hepatitis B vaccines net sales, adjusted for company estimates regarding HEPLISAV-B dosing regimen and pricing. 2 Internal estimate. Segment expansions assumes 50% of ACIP universal growth from Retail, 35% from IDN/Large Clinics and 15% from Small Clinics/Ind. No ACIP universal growth in Dialysis or Other (Dept of Corrections, Occupational Health), adjusted for company estimates regarding HEPLISAV-B dosing regimen and pricing. 3 The 4-dose regimen for the dialysis population is not currently approved regimen. Safety and effectiveness have not been established in patients on hemodialysis. 4 IDN and Large clinics are the segment targeted by our salesforce representing “Field-targeted”
Continued Growth in HEPLISAV-B Vaccine Market Share 33% Dialysis1 Centers 9% HEPLISAV-B Vaccine Market Share2 Source: Internal Data and company estimates. Market Segments by dose distribution reflects Q4 2020, Q4 2021 and Q4 2022. Not independently verified. 1 Based on 2022 U.S. adult hepatitis B vaccines net sales, adjusted for company estimates regarding HEPLISAV-B dosing regimen and pricing. 2 Market share data are for Q4 of each year and do not reflect interim periods (including preliminary, estimated market share for Q4 2022). 3 The 4-dose regimen for the dialysis population is not currently approved regimen. Safety and effectiveness have not been established in patients on hemodialysis. 4 IDN and Large clinics are the segment targeted by our salesforce representing “Field-targeted”. HEPLISAV-B ‘Field-targeted’ Market Share4 HEPLISAV-B Total Market Share IDN / Large Clinics 3 Field Targeted accounts Hepatitis B Non-Targeted Locationswith <30 doses per year 27% IDN/ Large Clinics4 “Field Targeted” 30% Small Clinics/Ind. 27% Retail 14% Other 18% Dialysis3 11% 2022 Adult Hepatitis B Vaccine Market Size $375M1 © Copyright DYNAVAX 2023
Vaccine Development Tetanus, Diphtheria, and Pertussis (Tdap) | Herpes Zoster (Shingles) | Plague © Copyright DYNAVAX 2023 15 |
High Unmet Need Exists for Addressing Resurgence of Pertussis Globally ~24 million cases of pertussis2 160,700 Tetanus and diphtheria are rare, but pertussis continues to spread.1 deaths2 Globally In the U.S. Since 1991, when acellular pertussis vaccines replaced whole-cell vaccines, whooping cough cases have increased by 85% due to: Acellular booster added Acellular replaces whole cell Waning efficacy: Effectiveness decreases 40-60% four years post vaccination2 Asymptomatic transmission: current acellular vaccines do not prevent asymptomatic infection or transmission3 Reported US Cases 1990-2019 2 © Copyright DYNAVAX 2023 Sources: 1 Updated as of January 2023 (data through 2019) Source: Centers for Disease Control and Prevention (https://www.cdc.gov/pertussis/surv-reporting/cases-by-year.html) 2 https://www.cdc.gov/vaccines/vd/dtap-tdap-td/public/index.html 3 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4482312 Tdap
DV2-TDAP-01: Tdap Booster Vaccine Phase 1Competitive efficacy and safety profile emerging Update and Next Steps: Phase 1 clinical results were presented in October 2022: Adult and adolescent safety data demonstrated the Tdap vaccine candidate was well tolerated without safety concerns. Immunogenicity in adults and adolescents were consistent with expectations and support the plan to continue advancement of this clinical program. In 2023, we intend to complete and evaluate NHP challenge study, assess regulatory pathway with FDA, to support initiation of our vaccine human challenge study CpG 1018 adjuvant expected to improve the durability and protection against pertussis colonization in the upper airways by redirecting T cell responses and enhancing protective antibody responses in a booster vaccine. Randomized, blinded, active-controlled, dose escalation clinical trial to evaluate the safety, tolerability, and immunogenicity of an investigational Tdap booster vaccine utilizing CpG 1018 adjuvant compared to a licensed Tdap vaccine ANZCTR.ORG.AU IDENTIFIER: ACTRN12620001177943p 138 Total Participants 90 Adults 48 Adolescents Dose Ranging Comparative Multicenter (Australia) Tdap-1018 1500 µg Tdap-1018 3000 µg Boostrix 16 Weeks Study Duration Safety & Tolerability Immunogenicity Trial initiated: Jan. 2021Completed: August 2022 Tdap
Current Market-Leading Shingles Vaccine is Associated with Adverse Events1 – New Vaccine Options Needed Herpes Zoster (shingles) is an extremely painful consequence of the reactivation of a latent varicella-zoster virus (VZV), the same virus that causes varicella (chickenpox). In the U.S. Herpes zoster rates are increasing among adults in the U.S., especially among younger adults. The reason for the increase is unknown. The rates among older adults are plateauing.2 1 out of 3 people will develop herpes zoster in their lifetime ~1 million annual cases of herpes zoster 1 case per 100 people with herpes zoster hospitalized for complications annual incidence among people 60+ yrs. 1 - 4% © Copyright DYNAVAX 2023 In the U.S. Shingles 1 Package Insert - SHINGRIX (fda.gov) 2. Clinical Overview of Herpes Zoster (Shingles) | CDC https://www.cdc.gov/shingles/surveillance.html 2 https://www.cdc.gov/shingles/hcp/clinical-overview.html
DV2-ZOS-01: Shingles Vaccine Phase 1Opportunity to improve vaccine tolerability while maintaining comparable efficacy © Copyright DYNAVAX 2023 We believe CpG 1018 adjuvant MOA is ideal for an improved shingles vaccine due to its ability to generate high levels of CD4+ T cell responses, which is key in controlling reactivation of the zoster virus and preventing shingles. Update and Next Steps: Topline data from Phase 1 clinical trial reported in Jan. 2023 High antibody and CD4 positive T-cell vaccine response rates in all arms and similar to the comparator Robust increases in CD4 positive T-cells were observed in all Z-1018 arms, although lower than the comparator. Total frequency of solicited systemic adverse events and local post-injection reactions were similar across the Z-1018 arms and lower than the comparator Data to be submitted for presentation at an upcoming medical meeting in 1H:2023 Randomized, active-controlled, dose-escalation, multi-center Phase 1 clinical trial to evaluate the safety, tolerability, and immunogenicity of investigational herpes zoster (shingles) vaccine utilizing glycoprotein E (gE) plus CpG 1018 adjuvant (Z-1018) with and without aluminum hydroxide (alum) compared to Shingrix® CLINICALTRIALS.GOV NCT IDENTIFIER: NCT05245838 150 Total Participants 50-69 years of age Dose Ranging Comparative Multicenter (Australia) Z-1018vs. Shingrix 20 Weeks Study Duration Safety and TolerabilityImmunogenicity Trial initiated: Jan. 2022Completed: Oct. 2022 Shingles
Plague Remains a Threat to Humankind Plague is an infectious disease that can become severe if left untreated. As seen with the 2022 Mpox (monkeypox) outbreak, rare diseases that are endemic in remote parts of the world can suddenly spread and become a global threat. Government agencies research and stockpile medical countermeasures – biologics, drugs, devices – which may be used in the event of a potential public health emergency stemming from a biological attack or a naturally occurring emerging disease. Yersinia Pestis bacteria usually found in small mammals and their fleas that causes plague 7-10 days flu-like symptoms develop in people infected with plague © Copyright DYNAVAX 2023 Bubonic most common type of plague Pneumonic deadliest and most rapid form of plague Vaccination is an essential tool to prevent the spread of infectious disease, and timely accessibility is crucial to contain an outbreak. There is no approved vaccine in the U.S. Plague Source: WHO infographic: plague-february-2017-jpg.jpg (1500×2122) (who.int) What are Medical Countermeasures? | FDA
DV2-PLG-01: Plague Vaccine Phase 2 Contract © Copyright DYNAVAX 2023 Update and Next Steps: Phase 2 clinical trial – Conducted in collaboration with, and funded by, the U.S. Department of Defense MOA has potential to speed up time to protection with fewer doses compared to the 3-dose vaccine under development by U.S. Department of Defense. Ongoing randomized, active-controlled, observer-blind, multicenter Phase 2 trial of the immunogenicity, safety and tolerability of rF1V vaccine with CpG 1018 adjuvant compared with rF1V vaccine alone in adults. The trial is assessing a CpG-1018+alum two-dose regimen administered over one month compared to an alum-only adjuvanted three-dose regimen over six months. CLINICALTRIALS.GOV NCT IDENTIFIER: NCT05506969 200 Healthy Adults Multicenter (US) CpG 1018+rFIVrFIV Safety and TolerabilityImmunogenicity Trial initiated: Aug 2022Ongoing through 2024 Plague
COVID-19 CpG 1018 Adjuvant Supply Business © Copyright DYNAVAX 2023
Continued Public Health Focus Despite Pandemic to Endemic Transition Despite incredible progress, unmet needs remain in COVID-19 as the pandemic continues, with a significant portion of the world population remaining unvaccinated. COVID-19 >657 million cases1 Of COVID-19 have been confirmed >28%4 Of people worldwide remain unvaccinated >6.6M deaths2 The majority5 Of that 28% live in developing countries Globally A Vaccine Gap Have been attributed to COVID-19 13 billion doses3 Of COVID-19 vaccines have been administered Sources: 1, https://covid19.who.int confirmed cases are as of 6 January 2023, there have been approximately 658 million confirmed cases 2 https://covid19.who.int/ 3, 4, 5 https://www.nytimes.com/interactive/2021/world/covid-vaccinations-tracker.html © Copyright DYNAVAX 2023
Well-positioned to Support Evolving Endemic COVID-19 Market Significant safety, efficacy and immunogenicity data for CpG 1018 adjuvant generated across multiple antigen platforms Minimal CpG 1018 adjuvant demand expected from customers in 2023 due to inventory on hand Additional potential demand for 2024 and beyond © Copyright DYNAVAX 2023 COVID-19 EUA approval in Indonesia for adults 18+1 EUA approval in India for ages 5+1 EUA approval in Taiwan and Paraguay for adults 18+1 EUA approval in Bahrain and United Arab Emirates for adults 18+; CMA granted in UK for adults 18+; EU approval1 EUA approval in China for ages 18+1 Product developer status as of January 6, 2023, as publicly disclosed by them
Propelling Future Growth © Copyright DYNAVAX 2023 25 |
Delivering on Dynavax’s Value Proposition © Copyright DYNAVAX 2023 Focused on Commercial Business and Clinical Pipeline Building on Key 2022 Accomplishments 2023 Outlook HEPLISAV-B preliminary net sales of $126 million (104% Y/Y growth) Strengthened financial profile through successful execution COVID-19 CpG 1018 adjuvant commercial supply Tdap Phase 1 completed; data presented in October 2022 Shingles Phase 1 completed; topline results reported in Jan 2023 Plague Phase 2 trial initiated HEPLISAV-B continued growth and expansion of market share Advance differentiated clinical pipeline including Shingles Phase 1 data to be presented in 1H 2023 and Tdap human challenge initiation by end of 2023 Identify and pursue strategic opportunities to accelerate growth