Aankondiging • Feb 11
Dynavax Technologies Corporation(NasdaqGS:DVAX) dropped from NASDAQ Composite Index Dynavax Technologies Corporation removed Board Change • Dec 30
High number of new directors There are 5 new directors who have joined the board in the last 3 years. Director Lauren Silvernail was the last director to join the board, commencing their role in 2025. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Aankondiging • Dec 24
Sanofi (ENXTPA:SAN) agreed to acquire Dynavax Technologies Corporation (NasdaqGS:DVAX) for $1.9 billion. Sanofi (ENXTPA:SAN) agreed to acquire Dynavax Technologies Corporation (NasdaqGS:DVAX) for $1.9 billion on December 24, 2025. A cash consideration of $49.93 million valued at $4.49 per share and of $1.93 billion valued at $15.5 per share will be paid by Sanofi. As part of consideration, $22.3 million is paid towards PSU units, $88.38 million is paid towards RSU units, $1.82 billion is paid towards common equity and $49.93 million is paid towards options of Dynavax Technologies Corporation. Upon following the successful completion of the tender offer, a wholly owned subsidiary of Sanofi will merge with and into Dynavax, and all of the outstanding Dynavax common stock that are not tendered in the tender offer will be converted into the right to receive the same $15.50 per share in cash offered to Dynavax shareholders in the tender offer. Sanofi plans to fund the acquisition with available cash resources.
The transaction is subject to approval by regulatory board, approval of merger agreement subject to antitrust regulations. The deal has been unanimously approved by the board. The acquisition is expected to close in the first quarter of 2026.
Goldman Sachs & Co. LLC acted as a financial advisor to Dynavax Technologies. Centerview Partners LLC acted as a financial advisor to Dynavax Technologies. Cooley LLP acted as a legal advisor to Dynavax Technologies. Aankondiging • Nov 07
Dynavax Technologies Corporation Reiterates Earnings Guidance for the Year 2025 Dynavax Technologies Corporation reiterated earnings guidance for the year 2025. For the year, the company expects for HEPLISAV-B net product revenue to be in the range of $315 million to $325 million. Aankondiging • Nov 06
Dynavax Technologies Corporation (NasdaqGS:DVAX) announces an Equity Buyback for $100 million worth of its shares. Dynavax Technologies Corporation (NasdaqGS:DVAX) announced a share repurchase program. Under the program, the company will repurchase up to $100 million of its common stock. The program will reduce the company's cash reserves. The program does not have an expiration date, and company currently expects that purchases will be executed within a period of up to one year. Aankondiging • Oct 23
Dynavax Technologies Corporation to Report Q3, 2025 Results on Nov 05, 2025 Dynavax Technologies Corporation announced that they will report Q3, 2025 results After-Market on Nov 05, 2025 Aankondiging • Oct 22
Dynavax Technologies Corporation Presents Positive Topline Data from Part 1 of Phase 1/2 Trial for Shingles Vaccine Candidate at IDWeek 2025 and Announces Initiation of Part 2 of Trial Dynavax Technologies Corporation presented positive topline data from Part 1 of its randomized, observer-blinded, active-controlled Phase 1/2 clinical trial of Z-1018, the Company's novel shingles vaccine candidate, in a late-breaker session at IDWeek 2025. Dynavax also announced it has initiated Part 2 of the trial evaluating Z-1018 head-to-head versus Shingrix®? in older adults. Key highlights of the data presentation included: Z-1018 adjuvanted with CpG 1018 (with or without alum) showed favorable tolerability and strong humoral and cellular responses across a range of Dynavax-produced gE dosage levels and dosing intervals; Z-1018 groups elicited high anti-gE IgG concentrations, robust CD4+ T-cell frequencies, and VRRs (per IgG and CD4+ criteria) comparable to Shingrix, at 4 weeks after dose 2; In new data presented at IDWeek, Z-1018 induced a high proportion of polyfunctional CD4+ T-cell responses exhibiting multiple gE-specific activation markers, supporting the quality and breadth of the cellular immune response; Formulation consisting of 100 mcg gE adjuvanted with Cp G 1018 plus alum, administered at 0 and 8 weeks, was selected for advancement to Part 2 of the Phase 1/2 trial in which adults aged 70 years and older are being enrolled. Part 2 Study Initiated: Dynavax also announced that the first participants have been dosed in Part 2 of the Phase 1-2 clinical trial. Part 2 of the Phase 1 1/2 trial is a randomized, active-controlled, multicenter study expected to enroll approximately 324 healthy adults aged 70 years and older at trial sites in Australia and New Zealand. The study is designed to further characterize immunogenicity, safety, and tolerability at the selected Z-1018 dose and regimen, including demonstrating non-inferiority to Shingrix on select immunogenicity measures. Dynavax anticipates reporting topline Part 2 immunogenicity and safety data in the second half of 2026. Aankondiging • Oct 16
Dynavax Technologies Corporation Announces Executive Changes In connection with an internal realignment of various management roles and responsibilities, on October 15, 2025, the Board of Directors (Board) of Dynavax Technologies Corporation (Company) approved the transition of David F. Novack from his roles as the company’s President and Chief Operating Officer to his new roles as Senior Vice President and Chief Operating Officer, effective January 1, 2026. The Board also approved the removal of Robert Janssen, M.D.’s roles as Chief Medical Officer and Senior Vice President, Clinical Development, Medical and Regulatory Affairs, effective upon the earlier to occur of (a) the date the Company employs a new Chief Medical Officer and (b) March 2, 2026, and further approved the conclusion of Dr. Janssen’s employment as of March 2, 2026. The Company has commenced a search process for a successor Chief Medical Officer. Aankondiging • Aug 21
Dynavax Technologies Corporation Announces Positive Topline Phase 1/2 Results Supporting Potential Best-In-Class Shingles Vaccine Profile Dynavax Technologies Corporation announced positive topline results from Part 1 of its randomized, observer-blinded, and active-controlled Phase 1/2 clinical trial of Z-1018, the Company's novel shingles vaccine candidate, head-to-head versus Shingrix in participants aged 50 to 69 years. Based on these results, Dynavax intends to advance Z-1018 into Part 2 of the Phase 1/2 program in adults 70 years of age and older, expected to initiate in the second half of 2025. In Part 1 of the trial at one month after the second vaccine dose, Z-1018 demonstrated antibody and CD4+ T cell vaccine responses similar to those observed in the comparator arm receiving Shingrix, the currently licensed shingles vaccine, with a favorable tolerability profile. At the dose formulation and regimen chosen for advancement to Part 2 of the trial, 12.5% of participants receiving Z-1018 reported grade 2 or 3 local PIRs and 27.5% reported grade 2 or 3 systemic PIRs, versus 52.6% and 63.2% for Shingrix, respectively. No safety concerns have been identified in this ongoingblinded study that has oversight by a safety monitoring committee. Aankondiging • Jul 30
Dynavax Technologies Corporation to Report Q2, 2025 Results on Aug 07, 2025 Dynavax Technologies Corporation announced that they will report Q2, 2025 results After-Market on Aug 07, 2025 Aankondiging • Jun 10
Deep Track Capital Sends Letter to Shareholders of Dynavax Technologies On June 9, 2025, Deep Track Capital, LP issued a letter to shareholders detailing the benefits of electing Dynavax Technologies Corporation’s 4 nominees – Brett Erkman, Jeffrey Farrow, Michael Mullette, and Donald Santel – to the Board of Directors at the upcoming 2025 annual meeting of shareholders on June 11, 2025. Deep Track’s nominees are prepared to collectively enter the boardroom with open-minded perspectives, constructive approach and sole focus on creating value for all shareholders. Deep Track Capital expressed its views that without meaningful Board change ‘valid and critical questions regarding the Company’s strategic direction, capital allocation, and Board responsiveness’ will remain unanswered. Deep Track Capital details urgent need to address Company’s consistent failure to achieve stated targets and reverse heplisav market share stagnation. Aankondiging • May 20
Deep Track Capital Posts Investor Presentation to its Campaign Website On May 19, 2025, Deep Track Capital, LP posted supplemental investor presentation to its campaign website at www.RefocusDVAX.com related to Dynavax Technologies Corporation. Aankondiging • May 16
Deep Track Capital Issues Letter to Fellow Shareholders of Dynavax Technologies On May 15, 2025, Deep Track Capital, LP issued a letter to shareholders in connection with its nomination of 4 candidates, Brett Erkman, Jeffrey Farrow, Donald Santel, and Michael Mullette for election to Dynavax Technologies Corporation’s Board of Directors at the 2025 annual meeting of stockholders. Aankondiging • May 13
Deep Track Capital Sends Letter to Shareholders of Dynavax Technologies Corporation On May 12, 2025, Deep Track Capital, LP sent a letter to shareholders of Dynavax Technologies Corporation urging the shareholders to vote for its nominees, Brett Erkman, Jeffrey Farrow, Michael Mullette, and Donald Santel, on the white proxy card at the Company’s annual shareholders meeting. Aankondiging • May 07
Dynavax Technologies Corporation Reaffirms Earnings Guidance for the Full Year 2025 Dynavax Technologies Corporation reaffirmed earnings guidance for the full year 2025. For the full year 2025, the company expects HEPLISAV-B net product revenue is expected in the range of $305 to $325 million. Aankondiging • Apr 23
Dynavax Technologies Corporation to Report Q1, 2025 Results on May 06, 2025 Dynavax Technologies Corporation announced that they will report Q1, 2025 results After-Market on May 06, 2025 Aankondiging • Apr 22
Deep Track Capital Files Definitive Proxy Statement and Sends Letter to Fellow Shareholders On April 21, 2025, Deep Track Capital, LP announced that it has filed a definitive proxy statement in connection with its nomination of 4 candidates for election to Dynavax Technologies Corporation’s Board of Directors at the 2025 annual meeting of stockholders. Deep Track also sent a letter to shareholders expressing the Company’s misguided acquisition strategy is destroying value and preventing the Company from maximizing the opportunities of heplisav for shareholders and patients. Aankondiging • Apr 18
Dynavax Technologies Corporation, Annual General Meeting, Jun 11, 2025 Dynavax Technologies Corporation, Annual General Meeting, Jun 11, 2025. Aankondiging • Apr 16
Deep Track Capital Comments on Dynavax Technologies’ Rejection of Settlement Offer On April 16, 2025, Deep Track Capital LP Commented on the Dynavax Technologies Corporation’s disclosure that the Board of Directors has rejected a settlement proposal in connection with its nomination of 4 candidates for election to the Board at the 2025 annual meeting of shareholders. Deep Track Capital proposed a 3-part proposal to the Company, that 1) Deep Track nominees Brett Erkman and Donald Santel would be appointed to the Board, 2) 2 long-tenured incumbent directors would step down; and 3) the Board would rebalance its classes such that there are 3 directors in each, and it is designed to ensure that a shareholder representative would be in the boardroom and to avoid a proxy contest, and the Company ejected this proposed settlement, and merely reiterated a prior proposal that it has now put forth for a third time. Deep Track criticized the Board's unwillingness to compromise, emphasized the need for investor-driven change and representation in the boardroom, and highlighted its commitment to protecting shareholders' interests and ensuring their voices are heard. Further, Deep Track stated that it remains open to discussions around how to resolve this situation in an amicable fashion, it is committed to protecting the best interests of all Company shareholders and ensuring their voices are heard. Aankondiging • Mar 10
Deep Track Capital Sends Letter to Dynavax Technologies’ Board of Directors On March 10, 2025, Deep Track Capital LP announced that it has sent a letter to Dynavax Technologies Corporation’s board of directors, stating that investor feedback supporting its course of action and sharing concerns with company’s capital allocation strategy, poor governance, and lack of shareholder perspective in the boardroom, and there is a desire for a shareholder representative on the Board. Deep Track criticizes the Board for obstructing shareholder rights and mischaracterizing its intentions and highlighted the Company’s refusal to reach a constructive resolution and calls on board to stop engaging in Petty defense tactics, Deep Track questions the issuance of expensive convertible notes instead of using cash on hand and mentioned that the recent refinancing decision is seen as unsophisticated and costly. Deep Track emphasizes the need for new directors to drive strategic improvements and stating that its actions are not about taking control but ensuring better governance and shareholder representation. Aankondiging • Mar 07
Dynavax Technologies Corporation announced that it expects to receive $39.7 million in funding Dynavax Technologies Corporation entered into subscription agreement for issuance of 2.50% Convertible Senior Notes due 2026 for gross proceeds of $39.7 million on March 5, 2025. The transaction is expected to close on or about March 13, 2025, subject to customary closing conditions. The New Notes will be issued pursuant to the exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”). The Company is relying on this exemption from registration based in part on representations made by the investors in the New Notes in the Exchange and Subscription Agreements. Aankondiging • Feb 21
Dynavax Technologies Corporation Provides Revenue Guidance for the Full Year 2025 Dynavax Technologies Corporation provided revenue guidance for the full year 2025. For the year, the company expects HEPLISAV-B net product revenue is expected in the range of $305 million to $325 million. Aankondiging • Feb 08
Dynavax Technologies Corporation Announces Principal Accounting Officer Changes On February 3, 2025, Justin Burgess notified Dynavax Technologies Corporation (the “Company”) that he intends to resign from the Company, including his position as the Company’s principal accounting officer, on or about March 3, 2025. The Company intends to appoint Kelly MacDonald, the Company’s Chief Financial Officer and principal financial officer, as the Company’s principal accounting officer, prior to March 3, 2025. There are no arrangements or understandings between Ms. MacDonald and any other persons in connection with Ms. MacDonald’s appointment as a principal accounting officer. Aankondiging • Feb 07
Dynavax Technologies Corporation to Report Q4, 2024 Results on Feb 20, 2025 Dynavax Technologies Corporation announced that they will report Q4, 2024 results After-Market on Feb 20, 2025 Aankondiging • Jan 28
Dynavax Technologies Corporation Announces Board Changes Dynavax Technologies Corporation announced the following changes to its Board of Directors as part of its ongoing refreshment program: Emilio Emini, Ph.D. and Lauren Silvernail have been appointed to the Board, effective February 3, 2025. Dr. Emini will serve as a Class III director with an initial term expiring at the Company's 2027 Annual Meeting and Ms. Silvernail will serve as a Class I director with an initial term expiring at the Company's 2025 Annual Meeting. Peggy Phillips, who has served on the Dynavax Board since 2006, will retire from the Board at the 2025 Annual Meeting. Julie Eastland will step down from the Board at the 2025 Annual Meeting given her recent appointment as chief executive officer of another public company. Dr. Emini brings over 40 years of experience as an executive and academic across the biopharmaceutical industry and global public health roles, helping to develop and deliver multiple anti-infectious disease interventions. Prior to his retirement, Dr. Emini served as Chief Executive Officer of the Bill & Melinda Gates Medical Research Institute and as the Director of the Foundation's Tuberculosis and HIV Programs. At the Merck Research Laboratories, from 1983 to 2004, Dr. Emini led the biological research that developed the first highly active antiretroviral therapies for HIV and led multiple vaccine research teams that contributed to many successful developments, including the vaccines for human papillomavirus and rotavirus. Following a two-year leave from the industry at the International AIDS Vaccine Initiative, Dr. Emini joined Wyeth/Pfizer as the Senior Vice President of Vaccine R&D where he led the development of the Prevenar 13® vaccine for prevention of pneumococcal disease. Dr. Emini holds a Bachelor of Science from Manhattan College and a Ph.D. in Microbiology from the Cornell University Graduate School of Medicine. Ms. Silvernail has three decades of experience leading finance and business development functions across the pharmaceutical industry. She most recently served as Chief Financial Officer and Executive Vice President of Corporate Development of Evolus Inc., from 2018 until her retirement in 2022, where she led fundraising, financial and partnership activities including establishing the infrastructure for the U.S. commercial launch of the company's first approved product. Previously, she served as Chief Financial Officer and Chief Business Officer at Revance Therapeutics Inc., where she led the company's initial public offering and subsequent rounds of financing. Prior to that, Ms. Silvernail was Chief Financial Officer and Executive Vice President of Corporate Development at ISTA Pharmaceuticals until its sale to Bausch & Lomb. Prior to that, she held corporate development roles at Allergan and other companies. Ms. Silvernail is currently a director and Audit Committee Chair of Harrow and previously served as a director and Audit Committee Chair at Harpoon Therapeutics until its successful sale to Merck and a director and Corporate Governance Committee chair at Nicox S.A. She earned an M.B.A. in finance and accounting from the Anderson Graduate School of Management at UCLA, and a B.A. in Biophysics from the University of California, Berkeley. Reported Earnings • Nov 08
Third quarter 2024 earnings released: EPS: US$0.13 (vs US$0.11 in 3Q 2023) Third quarter 2024 results: EPS: US$0.13 (up from US$0.11 in 3Q 2023). Revenue: US$80.6m (up 16% from 3Q 2023). Net income: US$17.6m (up 23% from 3Q 2023). Profit margin: 22% (up from 21% in 3Q 2023). The increase in margin was driven by higher revenue. Revenue is forecast to grow 17% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, earnings per share has fallen by 33% per year but the company’s share price has only fallen by 9% per year, which means it has not declined as severely as earnings. Aankondiging • Oct 25
Dynavax Technologies Corporation to Report Q3, 2024 Results on Nov 07, 2024 Dynavax Technologies Corporation announced that they will report Q3, 2024 results After-Market on Nov 07, 2024 Reported Earnings • Aug 07
Second quarter 2024 earnings released: EPS: US$0.087 (vs US$0.027 in 2Q 2023) Second quarter 2024 results: EPS: US$0.087 (up from US$0.027 in 2Q 2023). Revenue: US$73.8m (up 23% from 2Q 2023). Net income: US$11.4m (up 232% from 2Q 2023). Profit margin: 15% (up from 5.7% in 2Q 2023). The increase in margin was driven by higher revenue. Revenue is forecast to grow 17% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, earnings per share has fallen by 8% per year whereas the company’s share price has fallen by 3% per year. Aankondiging • Jul 24
Dynavax Technologies Corporation to Report Q2, 2024 Results on Aug 06, 2024 Dynavax Technologies Corporation announced that they will report Q2, 2024 results After-Market on Aug 06, 2024 Aankondiging • Jun 28
Dynavax Technologies Corporation Initiates Phase 1/2 Study of Novel Shingles Vaccine Program Dynavax Technologies Corporation announced that the first participant has been dosed in a Phase 1/2 clinical trial evaluating the safety, tolerability, and immunogenicity of Z-1018, the company's investigational vaccine candidate being developed for the prevention of shingles (herpes zoster), a debilitating disease caused by the varicella-zoster virus. The Phase 1/2 randomized, active-controlled, dose escalation, multicenter trial is expected to enroll approximately 440 healthy adults aged 50 to 69 years at trial sites in Australia, and will evaluate the safety, tolerability, and immunogenicity of Z-1018 compared to Shingrix®. Key objectives of the trial include selecting the optimal glycoprotein E (gE) protein dose level and dosing schedule for further clinical development. The Phase 1/2 trial will be used to support validation of a Patient Reported Outcome measurement tool to differentiate Z-1018 on tolerability and to support potential label claims. 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. Aankondiging • May 15
Dynavax Technologies Corporation Provides Regulatory Update on sBLA for Four-Dose HEPLISAV-B® Regimen for Adults on Hemodialysis in the U.S Dynavax Technologies Corporation provided a regulatory update for the company's supplemental Biologics License Application (sBLA) to include a four-dose HEPLISAV-B® vaccine [Hepatitis B Vaccine (Recombinant), Adjuvanted] regimen for adults on Hemodialysis. The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) in response to the sBLA, stating that the application did not provide sufficient data to support the full evaluation of effectiveness or safety of a four-dose regimen of HEPLISAV-B. The CRL has no impact on the approved indication for HEPLISAV-B in the U.S., the European Union, and Great Britain, which is for the prevention of infection caused by all known subtypes of hepatitis B virus in adults 18 years of age and older. The CRL also does not affect the approval decision received from the European Commission in October 2023 for the four-dose HEPLIS AV-B regimen for the adult hemodialysis population. The sBLA was comprised of clinical immunogenicity and safety data from the Phase 1 HBV-24 study of a four-dose regimen. The CRL stated that the data from HBV-24 were insufficient due to the destruction of data source documents by a third-party clinical trial site operator for approximately half of the subjects enrolled in the trial. In addition, the total number of subjects in the single-arm HBV-24 study was deemed to be insufficient to evaluate safety of the four-dose regimen. 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. 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%). Aankondiging • May 10
Dynavax Technologies Corporation Reaffirms Financial Guidance for the Full Year 2024 Dynavax Technologies Corporation reaffirmed financial guidance for the full year 2024. For the year, the company expects HEPLISAV-B net product revenue between approximately $265 million - $280 million, including approximately $3 million in ex-U.S. sales through commercialization partnership in Germany. Reported Earnings • May 09
First quarter 2024 earnings released: US$0.067 loss per share (vs US$0.19 loss in 1Q 2023) First quarter 2024 results: US$0.067 loss per share (improved from US$0.19 loss in 1Q 2023). Revenue: US$50.8m (up 8.2% from 1Q 2023). Net loss: US$8.72m (loss narrowed 64% from 1Q 2023). Revenue is forecast to grow 19% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, earnings per share has increased by 24% per year whereas the company’s share price has increased by 22% per year. Aankondiging • Apr 26
Dynavax Technologies Corporation to Report Q1, 2024 Results on May 08, 2024 Dynavax Technologies Corporation announced that they will report Q1, 2024 results at 4:00 PM, US Eastern Standard Time on May 08, 2024 Aankondiging • Apr 12
Dynavax Technologies Corporation, Annual General Meeting, May 23, 2024 Dynavax Technologies Corporation, Annual General Meeting, May 23, 2024, at 09:00 Pacific Standard Time. Agenda: To consider and elect our three nominees for Class III directors to hold office until the 2027 Annual Meeting of Stockholders or until their respective successors are duly elected and qualified; to consider and approve the amendment and restatement of the Dynavax Technologies Corporation 2018 Equity Incentive Plan to, among other things, increase the aggregate number of shares of common stock authorized for issuance under the plan by 11,400,000; to consider and approve, on an advisory basis, the compensation of the Company’s named executive officers, as disclosed in the proxy statement accompanying this Notice; and to transact such other business matters. New Risk • Feb 24
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 2.3% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. This is currently the only risk that has been identified for the company. Reported Earnings • Feb 23
Full year 2023 earnings released: US$0.05 loss per share (vs US$2.32 profit in FY 2022) Full year 2023 results: US$0.05 loss per share (down from US$2.32 profit in FY 2022). Revenue: US$232.3m (down 68% from FY 2022). Net loss: US$6.39m (down 102% from profit in FY 2022). Revenue is forecast to grow 18% p.a. on average during the next 3 years, compared to a 13% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has increased by 54% per year but the company’s share price has only increased by 13% per year, which means it is significantly lagging earnings growth. Aankondiging • Feb 23
Dynavax Technologies Corporation Provides Revenue Guidance for the Year 2024 Dynavax Technologies Corporation provided revenue guidance for the year 2024. The company expects HEPLISAV-B net product revenue between approximately $265 million - $280 million, including approximately $3 million in ex-U.S. sales through commercialization agreement with Bavarian Nordic in Germany. Aankondiging • Feb 09
Dynavax Technologies Corporation to Report Q4, 2023 Results on Feb 22, 2024 Dynavax Technologies Corporation announced that they will report Q4, 2023 results After-Market on Feb 22, 2024 Aankondiging • Nov 03
Dynavax Technologies Corporation Revises Earnings Guidance for the Full Year 2023 Dynavax Technologies Corporation revised earnings guidance for the full year 2023. For the year, the company expects HEPLISAV-B net product revenuebetween approximately $210 million - $220 million, compared to the prior range of approximately $200 million - $215 million. Reported Earnings • Nov 03
Third quarter 2023 earnings released: EPS: US$0.11 (vs US$0.50 in 3Q 2022) Third quarter 2023 results: EPS: US$0.11 (down from US$0.50 in 3Q 2022). Revenue: US$69.5m (down 59% from 3Q 2022). Net income: US$14.3m (down 78% from 3Q 2022). Profit margin: 21% (down from 38% in 3Q 2022). Revenue is forecast to grow 10% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has increased by 83% per year but the company’s share price has only increased by 55% per year, which means it is significantly lagging earnings growth. Aankondiging • Oct 27
Dynavax Technologies Corporation to Report Q3, 2023 Results on Nov 02, 2023 Dynavax Technologies Corporation announced that they will report Q3, 2023 results After-Market on Nov 02, 2023 Reported Earnings • Aug 04
Second quarter 2023 earnings released: EPS: US$0.027 (vs US$1.02 in 2Q 2022) Second quarter 2023 results: EPS: US$0.027 (down from US$1.02 in 2Q 2022). Revenue: US$60.2m (down 77% from 2Q 2022). Net income: US$3.43m (down 97% from 2Q 2022). Profit margin: 5.7% (down from 50% in 2Q 2022). Revenue is forecast to grow 6.7% p.a. on average during the next 3 years, compared to a 14% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has increased by 105% per year but the company’s share price has only increased by 22% per year, which means it is significantly lagging earnings growth. Aankondiging • Jul 23
Dynavax Technologies Corporation to Report Q2, 2023 Results on Aug 03, 2023 Dynavax Technologies Corporation announced that they will report Q2, 2023 results After-Market on Aug 03, 2023 Recent Insider Transactions • May 08
President & COO recently sold €174k worth of stock On the 4th of May, David Novack sold around 18k shares on-market at roughly €9.91 per share. This transaction amounted to 85% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. David has been a net seller over the last 12 months, reducing personal holdings by €819k. Aankondiging • May 04
Dynavax Technologies Corporation Reaffirms Revenue Guidance for the Year 2023 Dynavax Technologies Corporation reaffirmed revenue guidance for the year 2023. The company is reaffirming HEPLISAV-B net product revenue guidance for full year 2023 of between $165–$185 million, representing annual revenue growth of 30%-47%. Reported Earnings • May 03
First quarter 2023 earnings released: US$0.19 loss per share (vs US$0.26 profit in 1Q 2022) First quarter 2023 results: US$0.19 loss per share (down from US$0.26 profit in 1Q 2022). Revenue: US$46.9m (down 59% from 1Q 2022). Net loss: US$24.3m (down 174% from profit in 1Q 2022). Revenue is forecast to grow 10% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has increased by 118% per year but the company’s share price has only increased by 36% per year, which means it is significantly lagging earnings growth. Reported Earnings • Feb 24
Full year 2022 earnings released: EPS: US$2.32 (vs US$0.62 in FY 2021) Full year 2022 results: EPS: US$2.32 (up from US$0.62 in FY 2021). Revenue: US$722.7m (up 65% from FY 2021). Net income: US$293.2m (up 306% from FY 2021). Profit margin: 41% (up from 17% in FY 2021). The increase in margin was driven by higher revenue. Revenue is expected to decline by 11% p.a. on average during the next 3 years, while revenues in the Biotechs industry in Europe are expected to grow by 18%. Over the last 3 years on average, earnings per share has increased by 123% per year but the company’s share price has only increased by 41% per year, which means it is significantly lagging earnings growth. Aankondiging • Feb 10
Dynavax Technologies Corporation to Report Q4, 2022 Results on Feb 23, 2023 Dynavax Technologies Corporation announced that they will report Q4, 2022 results at 4:00 PM, US Eastern Standard Time on Feb 23, 2023 Recent Insider Transactions • Nov 16
President & COO recently sold €646k worth of stock On the 8th of November, David Novack sold around 52k shares on-market at roughly €12.37 per share. This transaction amounted to 96% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. This was David's only on-market trade for the last 12 months. Reported Earnings • Nov 05
Third quarter 2022 earnings released: EPS: US$0.50 (vs US$0.24 loss in 3Q 2021) Third quarter 2022 results: EPS: US$0.50 (up from US$0.24 loss in 3Q 2021). Revenue: US$167.7m (up 57% from 3Q 2021). Net income: US$63.8m (up US$92.2m from 3Q 2021). Profit margin: 38% (up from net loss in 3Q 2021). The move to profitability was primarily driven by higher revenue. Revenue is expected to decline by 16% p.a. on average during the next 3 years, while revenues in the Biotechs industry in Germany are expected to grow by 21%. Over the last 3 years on average, earnings per share has increased by 119% per year but the company’s share price has only increased by 50% per year, which means it is significantly lagging earnings growth. Aankondiging • Nov 04
Dynavax Technologies Corporation Provides Revenue Guidance for the Year 2022 Dynavax Technologies Corporation provided revenue guidance for the year 2022. The company anticipates 2022 revenues, operating expenses, and other costs to be in the ranges shown below, consistent with the Company's previous financial guidance provided on August 4, 2022: Full-year CpG 1018 adjuvant net product revenues of between $550 million and $600 million. Aankondiging • Oct 21
Dynavax Technologies Corporation to Report Q3, 2022 Results on Nov 03, 2022 Dynavax Technologies Corporation announced that they will report Q3, 2022 results After-Market on Nov 03, 2022 Aankondiging • Sep 13
Dynavax Technologies Corporation Announces First Participant Dosed in A Phase 2 Clinical Trial Evaluating an Adjuvanted Plague Vaccine Dynavax Technologies Corporation in collaboration with the U.S. Department of Defense's (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) and supported by the DOD's Chemical and Biological Defense Program announced that the first participant has been dosed in a Phase 2 clinical trial evaluating the immunogenicity, safety, and tolerability of the JPEO-CBRND's Recombinant Plague (rF1V) vaccine combined with Dynavax's CpG 1018®adjuvant, in adults 18 to 55 years of age. As previously announced, Dynavax and the DOD executed an agreement which provides for approximately $22 million in funding over two and a half years to develop an improved recombinant plague vaccine adjuvanted with CpG 1018 adjuvant. Under the agreement, Dynavax will conduct a Phase 2 clinical trial combining its CpG 1018 adjuvant with the DOD's rF1V vaccine. The trial is assessing a two-dose regimen administered over one month. Previous clinical studies of the rF1V, not including CpG 1018 adjuvant, have evaluated a three-dose regimen over six months. Any future commercial supply agreements would be subject to a separate agreement between Dynavax and the U.S government. Valuation Update With 7 Day Price Move • Aug 25
Investor sentiment deteriorated over the past week After last week's 17% share price decline to €11.48, the stock trades at a forward P/E ratio of 13x. Average forward P/E is 22x in the Biotechs industry in Europe. Total returns to shareholders of 333% over the past three years. Valuation Update With 7 Day Price Move • Aug 11
Investor sentiment improved over the past week After last week's 21% share price gain to €16.50, the stock trades at a forward P/E ratio of 20x. Average forward P/E is 25x in the Biotechs industry in Europe. Total returns to shareholders of 522% over the past three years. Simply Wall St's valuation model estimates the intrinsic value at €18.23 per share. Reported Earnings • Aug 05
Second quarter 2022 earnings released: EPS: US$1.02 (vs US$0.039 in 2Q 2021) Second quarter 2022 results: EPS: US$1.02 (up from US$0.039 in 2Q 2021). Revenue: US$256.5m (up 386% from 2Q 2021). Net income: US$128.8m (up US$124.3m from 2Q 2021). Profit margin: 50% (up from 8.5% in 2Q 2021). The increase in margin was driven by higher revenue. Over the next year, revenue is expected to shrink by 15% compared to a 31% growth forecast for the industry in Germany. Over the last 3 years on average, earnings per share has increased by 107% per year but the company’s share price has only increased by 72% per year, which means it is significantly lagging earnings growth. Aankondiging • Aug 05
Dynavax Technologies Corporation Revises Earnings Guidance for the Year 2022 Dynavax Technologies Corporation revised earnings guidance for the year 2022. The Company now expects 2022 full-year CpG 1018 adjuvant COVID-19 supply revenue to be between $550 million and $600 million, based on committed orders, with an anticipated full-year gross margin of approximately 60%. Aankondiging • Jul 22
Dynavax Technologies Corporation to Report Q2, 2022 Results on Aug 04, 2022 Dynavax Technologies Corporation announced that they will report Q2, 2022 results After-Market on Aug 04, 2022 Valuation Update With 7 Day Price Move • Jul 08
Investor sentiment improved over the past week After last week's 21% share price gain to €14.09, the stock trades at a forward P/E ratio of 15x. Average forward P/E is 31x in the Biotechs industry in Europe. Total returns to shareholders of 327% over the past three years. Simply Wall St's valuation model estimates the intrinsic value at €19.25 per share. Valuation Update With 7 Day Price Move • Jun 15
Investor sentiment deteriorated over the past week After last week's 18% share price decline to €9.67, the stock trades at a forward P/E ratio of 10x. Average forward P/E is 31x in the Biotechs industry in Europe. Total returns to shareholders of 178% over the past three years. Valuation Update With 7 Day Price Move • May 18
Investor sentiment improved over the past week After last week's 21% share price gain to €9.22, the stock trades at a forward P/E ratio of 12x. Average forward P/E is 33x in the Biotechs industry in Europe. Total returns to shareholders of 60% over the past three years. Aankondiging • May 08
Dynavax Technologies Corporation Reaffirms Earnings Guidance for the Year 2022 Dynavax Technologies Corporation reaffirmed earnings guidance for the year 2022. For the full-year CpG 1018 adjuvant net product revenues of at least $550 million, with an associated gross margin of approximately 50%. Reported Earnings • May 07
First quarter 2022 earnings released: EPS: US$0.26 (vs US$0.007 in 1Q 2021) First quarter 2022 results: EPS: US$0.26 (up from US$0.007 in 1Q 2021). Revenue: US$114.0m (up 37% from 1Q 2021). Net income: US$32.9m (up US$32.0m from 1Q 2021). Profit margin: 29% (up from 1.0% in 1Q 2021). The increase in margin was primarily driven by higher revenue. Over the next year, revenue is forecast to grow 29%, compared to a 37% growth forecast for the industry in Germany. Over the last 3 years on average, earnings per share has increased by 90% per year but the company’s share price has only increased by 12% per year, which means it is significantly lagging earnings growth. Aankondiging • Apr 22
Dynavax Technologies Corporation to Report Q1, 2022 Results on May 05, 2022 Dynavax Technologies Corporation announced that they will report Q1, 2022 results After-Market on May 05, 2022 Aankondiging • Apr 15
Dynavax Technologies Corporation, Annual General Meeting, May 26, 2022 Dynavax Technologies Corporation, Annual General Meeting, May 26, 2022, at 09:00 Pacific Standard Time. Agenda: To elect our five nominees for Class I directors to hold office until the 2025 Annual Meeting of Stockholders or until their respective successors are duly elected and qualified; To approve the amendment and restatement of the Dynavax Technologies Corporation 2018 Equity Incentive Plan to, among other things, increase the aggregate number of shares of common stock authorized for issuance under the plan by 15,000,000; To approve, on an advisory basis, the compensation of the Company's named executive officers, as disclosed in the proxy statement accompanying this Notice; and to ratify the selection of Ernst & Young LLP as the independent registered public accounting firm of the Company for its fiscal year ending December 31, 2022. Valuation Update With 7 Day Price Move • Mar 09
Investor sentiment deteriorated over the past week After last week's 18% share price decline to €8.85, the stock trades at a forward P/E ratio of 8x. Average forward P/E is 38x in the Biotechs industry in Europe. Total returns to shareholders of 14% over the past three years. Reported Earnings • Mar 02
Full year 2021 earnings: EPS in line with expectations, revenues disappoint Full year 2021 results: EPS: US$0.70 (up from US$0.75 loss in FY 2020). Revenue: US$439.4m (up US$392.9m from FY 2020). Net income: US$81.3m (up US$156.5m from FY 2020). Profit margin: 19% (up from net loss in FY 2020). The move to profitability was driven by higher revenue. Revenue missed analyst estimates by 2.2%. Over the next year, revenue is forecast to grow 60%, compared to a 64% growth forecast for the pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has increased by 75% per year but the company’s share price has only increased by 11% per year, which means it is significantly lagging earnings growth. Aankondiging • Mar 02
Dynavax Technologies Corporation Provides Revenue Guidance for the Full Year 2022 Dynavax Technologies Corporation provided revenue guidance for the Full Year 2022. For the year, the company expected CpG 1018 adjuvant net product revenues of at least $550 million, with associated gross margin of approximately 50%. Aankondiging • Feb 17
Dynavax Technologies Corporation to Report Q4, 2021 Results on Feb 28, 2022 Dynavax Technologies Corporation announced that they will report Q4, 2021 results After-Market on Feb 28, 2022 Breakeven Date Change • Dec 31
Forecast breakeven date pushed back to 2022 The 4 analysts covering Dynavax Technologies previously expected the company to break even in 2021. New consensus forecast suggests the company will make a profit of US$234.9m in 2022. Reported Earnings • Nov 06
Third quarter 2021 earnings released: US$0.24 loss per share (vs US$0.04 profit in 3Q 2020) The company reported a decent third quarter result with improved revenues, although earnings and control over costs were weaker. Third quarter 2021 results: Revenue: US$108.3m (up US$94.9m from 3Q 2020). Net loss: US$28.4m (down US$32.8m from profit in 3Q 2020). Over the last 3 years on average, earnings per share has increased by 57% per year but the company’s share price has only increased by 7% per year, which means it is significantly lagging earnings growth. Breakeven Date Change • Sep 23
Forecast to breakeven in 2021 The 5 analysts covering Dynavax Technologies expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$54.2m in 2021. Aankondiging • Aug 25
Medigen Vaccine Biologics Corporation and Dynavax Technologies Corporation Announces Launch of Its Covid-19 Vaccine Mvc-Cov1901 Adjuvanted with Dynavax's Cpg 1018 Adjuvant Medigen Vaccine Biologics Corporation, and Dynavax Technologies Corporation announced the rollout of its COVID-19 vaccine, MVC-COV1901. Approximately 600,000 people are anticipated to receive the Medigen vaccine this week. MVC-COV1901 is a subunit vaccine with recombinant S-2P antigen adjuvanted with CpG 1018 supplied by Dynavax and aluminum hydroxide. The S-2P antigen is a trimeric and prefusion-stable recombinant spike protein developed by the U.S.NIH. MVC has obtained a global technology license for S-2P from the U.S. Vaccine Research Center at National Institutes of Health (NIH). MVC-COV1901 vaccine's Phase 1 and 3,815-participant Phase 2 clinical study data has shown robust safety and promising immunogenicity responses and as a result obtained Taiwan's EUA approval on July 19th, 2021. MVC will continue to collaborate with international partners for phase 3 clinical trial development and assist the global community in its fight against the COVID-19 pandemic. Reported Earnings • Aug 06
Second quarter 2021 earnings released: EPS US$0.039 (vs US$0.53 loss in 2Q 2020) The company reported a strong second quarter result with improved earnings, revenues and profit margins. Second quarter 2021 results: Revenue: US$52.8m (up US$50.1m from 2Q 2020). Net income: US$4.47m (up US$56.1m from 2Q 2020). Profit margin: 8.5% (up from net loss in 2Q 2020). Over the last 3 years on average, earnings per share has increased by 46% per year but the company’s share price has fallen by 9% per year, which means it is significantly lagging earnings. Board Change • Jul 31
High number of new directors Independent Director Julie Eastland was the last director to join the board, commencing their role in 2020. Reported Earnings • May 08
First quarter 2021 earnings released: EPS US$0.008 (vs US$0.15 loss in 1Q 2020) The company reported a strong first quarter result with improved earnings, revenues and profit margins. First quarter 2021 results: Revenue: US$83.3m (up US$72.4m from 1Q 2020). Net income: US$891.0k (up US$13.5m from 1Q 2020). Profit margin: 1.1% (up from net loss in 1Q 2020). The move to profitability was driven by higher revenue. Over the last 3 years on average, earnings per share has increased by 30% per year but the company’s share price has fallen by 19% per year, which means it is significantly lagging earnings. Reported Earnings • Feb 27
Full year 2020 earnings released: US$0.75 loss per share (vs US$2.16 loss in FY 2019) The company reported a solid full year result with reduced losses, improved revenues and improved control over expenses. Full year 2020 results: Revenue: US$46.6m (up 32% from FY 2019). Net loss: US$75.2m (loss narrowed 52% from FY 2019). Over the last 3 years on average, earnings per share has increased by 18% per year but the company’s share price has fallen by 15% per year, which means it is significantly lagging earnings. Analyst Estimate Surprise Post Earnings • Feb 27
Revenue beats expectations Revenue exceeded analyst estimates by 16%. Over the next year, revenue is forecast to grow 409%, compared to a 52% growth forecast for the Biotechs industry in Germany. Aankondiging • Feb 20
Dynavax Technologies Corporation Announces European Commission Marketing Authorization for HEPLISAV B®, a 2 Dose Adult Hepatitis B Adjuvanted Vaccine Dynavax Technologies Corporation announced that the European Commission (EC) has granted Marketing Authorization for HEPLISAV B (Hepatitis B Vaccine (Recombinant), Adjuvanted) for the active immunization against hepatitis B virus infection (HBV) caused by all known subtypes of hepatitis B virus in adults 18 years of age and older. The approval was issued following the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) positive opinion on the company's Marketing Authorization Application. The approval and CHMP recommendation were based on the positive benefit-risk for HEPLISAV B as demonstrated by the safety and immunogenicity results of three Phase 3 clinical trials. European Commission marketing authorization approval is valid in all EU and EEA-European Free Trade Association (EFTA) states (Norway, Iceland and Liechtenstein). HEPLISAV-B is now approved in the U.S. and EU. Aankondiging • Feb 12
Dynavax Technologies Corporation to Report Q4, 2020 Results on Feb 25, 2021 Dynavax Technologies Corporation announced that they will report Q4, 2020 results After-Market on Feb 25, 2021 Aankondiging • Feb 09
Dong Yu Joins in Dynavax Technologies Corporation as Senior Vice President of Vaccine Research and A Member of the Executive Team Dynavax Technologies Corporation announced that Dong Yu, Ph.D., has joined the Company as Senior Vice President of Vaccine Research and a member of the Executive Team. Dr. Yu will drive Dynavax's vaccine programs and technology platforms, building and maintaining a pipeline for long-term company growth. Dr. Yu joins Dynavax after years at GSK Vaccines, where he held roles of increasing responsibility. Most recently, he was Head of Preclinical R&D U.S., responsible for leading the organization of more than 80 scientists with diverse expertise to drive preclinical R&D of GSK vaccines portfolio in the U.S. Additionally, Dr. Yu was one of twelve founding Vaccines Fellows recognized by GSK for his expertise in vaccines. Prior to GSK, Dr. Yu was at Novartis Vaccines where he led RNA biology and vector development as the Director and Function Head of Microbial Molecular Biology. Aankondiging • Feb 05
Dynavax Technologies Corporation and Serum Institute of India Announce First Participant Dosed in a Phase 1 Clinical Trial Evaluating an Improved Tdap Vaccine Adjuvanted with CpG 1018 Dynavax Technologies Corporation and Serum Institute of India jointly announced that the first participant has been dosed in a Phase 1 clinical trial evaluating a tetanus, diphtheria, and acellular pertussis (Tdap) booster vaccine candidate adjuvanted with CpG 1018. Dynavax and SIIPL are collaborating to develop an adjuvanted Tdap vaccine to address the shortcomings of the currently marketed acellular pertussis vaccines. Incidence of pertussis infection in the U.S. and other industrialized countries has been rising since the switch from whole cell pertussis to acellular pertussis vaccines in the 1990s. Although currently marketed acellular pertussis vaccines are effective at providing initial protection from disease, rates of pertussis continue to rise due to waning immunity over time. These vaccines may not prevent the pertussis bacteria from colonizing in the patient, potentially allowing previously vaccinated, asymptomatic individuals to spread the disease. This vaccine candidate has the potential to provide an alternative to the current booster dose given at 10 years of age and older with the goal of increasing the durability of the immune response and reducing transmission from vaccinated individuals who may still spread the disease even if they are asymptomatic. The Phase 1 randomized, open label, active-controlled, dose escalation clinical trial will evaluate the safety, tolerability, and immunogenicity of the vaccine candidate, adjuvanted with CpG?1018, in healthy volunteers 10 to 22 years of age. Dynavax anticipates results from the Phase 1 study to be available in the fourth quarter of 2021. Under the collaboration, Dynavax has exclusive world-wide rights to commercialize the vaccine, except that SII has exclusive rights to distribute in India and to fulfill WHO/UNICEF tender contracts. The parties are responsible for clinical development cost in their respective territories. Aankondiging • Feb 02
Dynavax Technologies Corporation Enters into an Agreement with the Coalition for Epidemic Preparedness Innovations Dynavax Technologies Corporation announced that it has entered into an agreement with the Coalition for Epidemic Preparedness Innovations, relating to the supply of the Company’s novel toll-like receptor 9 agonist adjuvant, CpG 1018™, at CEPI’s direction, to certain third parties who have agreements with CEPI regarding the funding of development and manufacturing initiatives of vaccines for COVID-19. The Agreement provides for the manufacture and initial reservation of a specified quantity of CpG 1018, and an option, exercisable in CEPI’s sole discretion prior to March 15, 2021, for the manufacture and reservation of an additional quantity of CpG 1018. The Initial Reserved Material is expected to be available for release during the second and third quarters of 2021. The Additional Reserved Material is expected to be available for release during the fourth quarter of 2021. The Agreement also provides CEPI with a first right to reserve additional supply of CpG 1018 to be deliverable in the fourth quarter of 2021, subject to the Company confirming that it has capacity to supply such additional amount. The Agreement enables CEPI, subject to certain limitations and requirements, to direct the supply of Reserved Material to CEPI Partners. CEPI Partners would then purchase CpG 1018 directly from the Company under separately negotiated agreements, subject in certain circumstances to specified pricing requirements. The Agreement also allows the Company to sell the Reserved Material to third-parties if not purchased by a CEPI Partner within a defined period of time. In exchange for the Company reserving CpG 1018 pursuant to the Agreement, CEPI has agreed to provide the Company with an interest-free, unsecured, forgivable loan in an amount equivalent to the anticipated manufacturing costs of all material reserved by CEPI under the Agreement, which, for the Initial Reserved Material and Additional Reserved Material, is up to $99 million (the “ Loan Amount”). Loan Amounts for the Initial Reserved Material will be funded in part upon the execution of the Agreement, in part upon the exercise of CEPI’s option to reserve the Additional Reserved Material, and in part upon the release of the applicable Reserved Material. The Company is obligated to repay the Loan Amount, on a proportional basis, if and to the extent the Company receives payment for the applicable CpG 1018 reserved under the Agreement. If the vaccine programs pursued by CEPI Partners are unsuccessful and no alternative use is found for the adjuvant funded through the Agreement, the applicable Loan Amount will be forgiven. The Agreement will terminate at the earlier of (a) such time as all Reserved Material has been sold and all portions of the Loan Amount have been repaid to CEPI and (b) the second anniversary of the date of the Agreement; provided, however, that the Company will remain obligated to repay any outstanding applicable Loan Amount to the extent that it subsequently receives payment for any Reserved Material that remains unsold as of such second anniversary. Aankondiging • Feb 01
Clover and Dynavax Announce Planned Global Phase 2/3 Efficacy Trial of Adjuvanted COVID-19 Vaccine Candidate Clover Biopharmaceuticals and Dynavax Technologies Corporation announced the plan to initiate a global Phase 2/3 efficacy trial with the S-Trimer COVID-19 vaccine candidate adjuvanted with CpG 1018 plus alum in the first half of 2021 with an interim analysis for vaccine efficacy potentially in the middle of 2021. The Coalition for Epidemic Preparedness Innovations (CEPI) will continue to support the development of Clover's COVID-19 vaccine candidate and will fund the development, including the Phase 2/3 trial, through licensure. In its Phase 1 clinical trial, Clover's protein-based COVID-19 S-Trimer vaccine candidates in combination with adjuvants from either Dynavax or GlaxoSmithKline plc (GSK, London Stock Exchange: GSK) both performed well and induced high levels of neutralizing antibodies while demonstrating favorable safety and tolerability profiles. Clover expects to produce hundreds of millions of vaccine doses in 2021 and up to 1 billion vaccine doses in peak annual production as required by global demand. Aankondiging • Jan 26
Medigen Vaccine Biologics Corporation Vaccine Biologics COVID-19 Vaccine Adjuvanted with Dynavax's CpG 1018 Announces First Participant Dosed in Phase 2 Clinical Trial in Taiwan Medigen Vaccine Biologics Corporation and Dynavax Technologies Corporation announced that the first participant has been dosed in the Phase 2 clinical trial evaluating MVC's COVID-19 vaccine candidate, MVC-COV1901. MVC-COV1901 is a subunit vaccine with recombinant S-2P antigen adjuvanted with CpG 1018 supplied by Dynavax. MVC's Phase 2 clinical trial is a randomized, double-blinded, multi-center clinical trial, expecting to enroll 3,700 healthy subjects, 20 years of age and above. The trial will evaluate MVC-COV1901 safety and endurance of immunogenicity. The proposed dosing regimen is two doses administered intramuscularly one month apart. Based on MVC's Phase 1 interim data, MVC-COV1901 has demonstrated a good safety profile and encouraging immunogenicity performance. MVC-COV1901 is a subunit vaccine with recombinant S-2P antigen adjuvanted with CpG 1018 supplied by Dynavax plus aluminum hydroxide. The S-2P antigen is a trimeric and prefusion-stable recombinant spike protein developed by U.S.NIH. MVC has obtained a global technology license for S-2P from the U.S. Vaccine Research Center at National Institutes of Health (NIH). Â Building upon the S-2P platform, MVC conducted large-scale screenings of various adjuvants and finalized the compositions of MVC-COV1901 vaccine to optimize safety and desired immunogenicity properties. MVC established the production platform of MVC-COV1901 and based on MVC's preclinical and phase 1 clinical study data, MVC-COV1901 showed robust safety and promising immunogenicity responses and as a result entered Phase 2 clinical trial in 2020.