DFAN14A 1 d944178ddfan14a.htm DFAN14A DFAN14A
 
 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

SCHEDULE 14A

(Rule 14A-101)

SCHEDULE 14A INFORMATION

Proxy Statement Pursuant to Section 14(a) of the

Securities Exchange Act of 1934

 

 

Filed by the Registrant ☐

Filed by a Party other than the Registrant ☒

Check the appropriate box:

 

Preliminary Proxy Statement

 

Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2))

 

Definitive Proxy Statement

 

Definitive Additional Materials

 

Soliciting material Pursuant to §240.14a-12

Dynavax Technologies Corporation

(Name of Registrant as Specified In Its Charter)

DEEP TRACK BIOTECHNOLOGY MASTER FUND, LTD.

DEEP TRACK CAPITAL, LP

DAVID KROIN

BRETT A. ERKMAN

JEFFREY S. FARROW

MICHAEL MULLETTE

DONALD J. SANTEL

(Name of Person(s) Filing Proxy Statement, if other than the Registrant)

Payment of Filing Fee (Check the appropriate box):

 

No fee required.

 

Fee paid previously with preliminary materials.

 

Fee computed on table below per Exchange Act Rules 14a-6(i)(4) and 0-11.

 

 
 


Deep Track Capital, LP, a Delaware limited partnership (“Deep Track”), together with the other participants named herein (collectively the “Participants”), posted the following supplemental investor presentation to its campaign website at www.RefocusDVAX.com (the “Website”), related to Dynavax Technologies Corporation, a Delaware corporation (the “Company”). From time to time, Deep Track and the other Participants may refer stockholders of the Company to such materials on the Website.


Adjuvant-Enhanced Pipeline May 2025 Presented by


Legal Disclaimer This presentation and any of the information contained herein (this is for discussion and general informational purposes only. This Presentation does not have regard for the specific investment objective, financial situation, suitability, or the particular need of any specific person who may receive this Presentation, and should not be taken as advice on the merits of any investment decision. This Presentation is not an offer to sell or the solicitation of an offer to buy interests in any fund, account or investment vehicle managed by Deep Track Capital, LP (together with its affiliates, and is being provided to you for informational purposes only. The views expressed herein represent the opinions of Deep Track, and are based on publicly available information with respect to Dynavax Technologies Corporation Dynavax or the . Certain financial information and data used herein have been derived or obtained from public filings, including filings made by the Company with the Securities and Exchange Commission and other sources. Certain statements and information included herein have been sourced from third parties. Deep Track does not make any representations regarding the accuracy, completeness or timeliness of such third-party statements or information. Except as may be expressly set forth herein, permission to cite such statements or information has neither been sought nor obtained from such third parties. Any such statements or information should not be viewed as an indication of support from such third parties for the views expressed herein. No warranty is made that data or information, whether derived or obtained from filings made with the SEC or from any third party, are accurate. No contract, agreement, arrangement, commitment, relationship or understanding exists or shall be deemed to exist between or among Deep Track and any third party or parties by virtue of furnishing this Presentation. Except for historical information contained herein, the matters addressed in this Presentation are forward-looking statements that involve certain risks and uncertainties. Specific forward- looking statements can be identified by the fact that they do not relate strictly to historical or current facts and include, without limitation, words such as or the negative of such terms or other variations on such terms or comparable terminology. Similarly, statements that describe our objectives, plans or goals are forward-looking. Forward-looking statements are subject to significant economic, competitive, regulatory and other risks and uncertainties and assumptions. There can be no assurance that any idea or assumption herein is, or will be proven, correct. If one or more of the risks or uncertainties materialize, or if Deep underlying assumptions prove to be incorrect, the actual results may vary materially from outcomes indicated by these statements. Accordingly, forward-looking statements should not be regarded as a representation by Deep Track that the future plans, estimates or expectations contemplated will ever be achieved. There is no assurance or guarantee with respect to the prices at which any securities of the Company will trade, and such securities may not trade at prices that may be implied herein. This Presentation does not recommend the purchase or sale of any security. Deep Track reserves the right to change any of its opinions expressed herein at any time as it deems appropriate. Deep Track disclaims any obligation to update or revise the information or expressed opinions contained herein. Under no circumstances is this Presentation to be used or considered as an offer to sell or a solicitation of an offer to buy any security. All registered or unregistered service marks, trademarks, and trade names referred to in this Presentation are the property of their respective owners, and Deep use herein does not imply an affiliation with, or endorsement by, the owners of such service marks, trademarks and trade names. Deep Track strongly advises all stockholders of the Company to read the definitive proxy statement, any amendments or supplements to such proxy statement and other proxy materials filed by Deep Track with the SEC as they become available because they will contain important information. Such proxy will be available at no charge on the SEC's website at www.sec.gov. The definitive proxy statement and other relevant documents, are also available on www.RefocusDVAX.com and the SEC website, free of charge, or by directing a request to the (as defined below) proxy solicitor, Innisfree, 501 Madison Avenue, 20th Floor, New York, New York, 10022 (stockholders can call toll-free: +1 (877) 687-1865). The Participants (the in the solicitation are Deep Track Capital, LP, Deep Track Biotechnology Master Fund, Ltd., David Kroin, Brett A. Erkman, Jeffrey S. Farrow, Michael Mullette and Donald J. Santel. 2


Key Points adjuvant, CpG 1018, provides a distinctive competitive edge that will lower development risk and ensure pipeline success. CpG 1018 does not improve the chances of successful development and commercialization.


Overview of Adjuvants and Vaccines An adjuvant is an ingredient used in some vaccines that helps create a stronger immune response in people receiving the vaccine. In other words, adjuvants help vaccines work better. 1 Dynavax was founded in 1996 on the basis of using proprietary immunostimulatory sequences (ISS) of DNA as adjuvants, one of which is CpG 1018. Each different adjuvant stimulates different immune responses and must be carefully studied. Different combinations of adjuvants and other vaccine components stimulate different immune responses and must be carefully studied dicate that owning CpG 1018 does not uniquely position Dynavax for success in creating new vaccines. 2 Adjuvants used in U.S. vaccines Adjuvant Composition Vaccines Aluminum One or more of the following: amorphous aluminum hydroxyphosphate sulfate Anthrax, DT, DTaP (Daptacel), DTaP (Infanrix), DTaP-HepB-IPV (Pediarix), DTaP- (AAHS), aluminum hydroxide, aluminum phosphate, IPV (Kinrix), DTaP-IPV (Quadracel), DTaP IPV/Hib (Pentacel), DTaP-IPV-Hib- potassium aluminum sulfate (Alum) HepB (VAXELIS), HepA (Havrix), HepA (Vaqta), HepB (Engerix-B), HepB (Recombivax), HepA/HepB (Twinrix), HIB (PedvaxHIB), HPV (Gardasil 9), Japanese encephalitis (Ixiaro), MenB (Bexsero, Trumenba), Pneumococcal (Prevnar 13, Prevnar 20, VAXNEUVANCE), Td (Tenivac), Td (Mass Biologics), Td (no trade name), Tdap (Adacel), Tdap (Boostrix), Tick-Borne Encephalitis (TICOVAC) AS01 Monophosphoryl lipid A (MPL) and QS-21, a natural compound extracted from B Zoster vaccine (Shingrix) the Chilean soapbark tree, combined in a liposomal formulation AS04 Monophosphoryl lipid A (MPL) + aluminum salt Human papillomavirus, or HPV (Cervarix) CpG 1018 Cytosine phosphoguanine (CpG), a synthetic form of DNA that mimics bacterial HepB (Heplisav-B) and viral genetic material TM Matrix-M Saponins derived from the soapbark tree (Quillaja saponaria Molina) COVID-19 vaccine (Novavax COVID-19 Vaccine, Adjuvanted) MF59 Oil in water emulsion composed of squalene Influenza (Fluad and Fluad Quadrivalent) 1 https://www3.scienceblog.com/community/older/1998/B/199801542.html 2 Source: CDC.gov, Adjuvants and Vaccines (December 20, 2024). 4


1 DVAX S-1 filed in 2003 As early as 2003, Dynavax was already attempting to specifically 2 leverage CpG 1018 (aka 1018 ISS) to develop drugs for: Ragweed allergy HBV prophylaxis Asthma Non- Other similar ISS adjuvants were also being developed for: Innate immunity Grass allergy HBV immunotherapy Rheumatoid arthritis Tree allergy Anthrax Peanut allergy Human viral influenza Only HBV prophylaxis after a tumultuous development path has made it across the finish line. All TWELVE other programs have failed or been suspended. This does not even count the program attempts between 2003 and today (e.g., Tdap terminated Nov 2024). This time is different is NOT a business strategy 1 DVAX S-1 filed Oct 24, 2003 5 2 Heplisav, FDA Summary Basis for Regulatory Action, https://www.fda.gov/media/109808/download (aka 1018 ISS)


After 20+ Years Of Trying, DVAX Only Has Heplisav to show for CpG 1018 CpG 1018 has already been tried in at least a dozen unique indications across over 40k patients and over two decades Since 2004 Many unique indications not comprehensive 40k+ patients NCT Number Start Date Study Status Conditions Sponsor Phases Enrollment NCT00251394 07/2004 COMPLETED Non-Hodgkin's Lymphoma Dana-Farber Cancer Institute PHASE2 30 NCT00426712 01/2006 COMPLETED Hepatitis B Dynavax Technologies Corporation PHASE1 42 NCT00403052 11/2006 TERMINATED Colorectal Neoplasms Dynavax Technologies Corporation PHASE1 14 NCT00498212 07/2007 TERMINATED Hepatitis B Dynavax Technologies Corporation PHASE2 41 NCT03934736 4/22/2019 COMPLETED End Stage Renal Disease on Hemodialysis (Diagnosis) Dynavax Technologies Corporation PHASE1 119 NCT04177355 1/13/2020 COMPLETED HIV Infections National Institute of Allergy and Infectious Diseases (NIAID) PHASE1 127 NCT04405908 6/19/2020 COMPLETED COVID-19 Clover Biopharmaceuticals AUS Pty PHASE1 166 NCT04450004 7/10/2020 COMPLETED SARS-CoV 2 Medicago PHASE1 180 NCT04487210 10/7/2020 COMPLETED COVID-19 Medigen Vaccine Biologics Corp. PHASE1 45 NCT04671017 12/16/2020 COMPLETED SARS-CoV-2 Virus Infection Valneva Austria GmbH PHASE1|PHASE2 153 NCT04830800 3/10/2021 COMPLETED COVID-19 Disease|SARS Pneumonia|Pneumonia, Viral|COVID-19 Vaccine Institute of Vaccines and Medical Biologicals, Vietnam PHASE1 120 NCT04764422 3/20/2021 COMPLETED Covid-19|SARS Pneumonia|Pneumonia, Viral|Covid-19 Vaccine Mahidol University PHASE1|PHASE2 455 NCT04672395 3/24/2021 COMPLETED COVID-19 Clover Biopharmaceuticals AUS Pty PHASE2|PHASE3 31454 NCT04864561 4/26/2021 COMPLETED SARS-CoV-2 Virus Infection Valneva Austria GmbH PHASE3 4034 NCT04956224 8/9/2021 COMPLETED SARS-CoV-2 Virus Infection Valneva Austria GmbH PHASE3 306 NCT04954131 8/10/2021 UNKNOWN COVID-19 Zhejiang Clover Biopharmaceuticals, Inc. PHASE2 766 NCT04950751 08/2021 WITHDRAWN COVID-19 Clover Biopharmaceuticals AUS Pty PHASE2 0 NCT05012787 11/12/2021 TERMINATED COVID-19 Clover Biopharmaceuticals AUS Pty PHASE3 1 NCT05087368 12/1/2021 UNKNOWN Covid19 D'Or Institute for Research and Education PHASE2 520 NCT05245838 1/10/2022 COMPLETED Shingles|Herpes Zoster|Vaccine-Preventable Diseases Dynavax Technologies Corporation PHASE1 150 NCT05228613 2/16/2022 COMPLETED COVID-19 PT Bio Farma PHASE1 175 NCT05313035 4/13/2022 COMPLETED COVID-19 PT Bio Farma PHASE2|PHASE3 360 NCT05364242 5/9/2022 COMPLETED SARS-CoV-2 Infection Valneva Austria GmbH PHASE2|PHASE3 178 NCT05433285 6/7/2022 COMPLETED COVID-19 PT Bio Farma PHASE3 4050 NCT04843852 07/2022 WITHDRAWN Hepatitis B University of Maryland, Baltimore PHASE1 0 NCT05506969 8/9/2022 COMPLETED Plague, Pneumonic|Plague|Vaccine-Preventable Diseases Dynavax Technologies Corporation PHASE2 200 NCT05298644 10/1/2022 WITHDRAWN SARS-CoV-2 Infection Valneva Austria GmbH PHASE2|PHASE3 0 NCT05545683 12/1/2022 WITHDRAWN COVID-19 Centro de Estudios en InfectogÃa Pediatrica PHASE3 0 NCT05606341 3/13/2023 RECRUITING Mild Cognitive Impairment|Alzheimer Dementia NYU Langone Health PHASE1 15 AIDS/HIV - RelatedDisease Associated With AIDS|Vaccine-Preventable Diseases|HIV NCT06541093 1/30/2024 ACTIVE_NOT_RECRUITING Infections Uvax Bio LLC EARLY_PHASE1 34 NCT06334393 03/25/2024 ACTIVE_NOT_RECRUITING Zika|Zika Virus Infection Valneva Austria GmbH PHASE1 150 Source: clinicaltrials.gov 6


The CpG 1018 Value Opportunity Has Already Proven to Be Highly Uncertain After 20+ years, CpG 1018 is used in only one FDA-approved vaccine The current Board has only overseen failures in pipeline development: x It failed to win an indication for Heplisav for hemodialysis after 20 years of development efforts. x It failed with the TDAP program. CpG 1018 provided a one-time revenue spike from COVID supply deals (2020-2022) but has generated $0 since in sales or partnerships. 1 once-in-a- - CEO Ryan Spencer, March 4, 2024 The value opportunity for CpG 1018 is limited and uncertain CpG 1018 is not approved for pediatric use, which is when the vast majority of vaccines are administered. effective). The vaccine development community is a small one and CpG 1018 is no secret. We believe if the bigger players in the space thought combining CpG 1018 with their own vaccine programs was compelling, they would have approached Dynavax at some point over the last 20 years for a license to do so. The Board has no justification for its confidence that Dynavax will be able to succeed with vaccine development in the future 1 CEO Ryan Spencer, March 4, 2024, speaking at Cowen conference 7


DVAX Has Tried Many Times to Develop a Flu Vaccine, Including with CpG 1018 2003 DVAX S-1 2003 1 2010 2 2020 3 2025 This time is different? 1 https://www.fiercebiotech.com/biotech/dynavax-initiates-first-human-trial-universal-flu-vaccine-program 2 https://www.globenewswire.com/news-release/2020/07/16/2063341/0/en/Dynavax-and-Mount-Sinai-Announce-Collaboration-to-Develop-a-Universal-Influenza-Vaccine-Candidate-with-CpG-1018-Adjuvant.html 8 3 https://investors.dynavax.com/news-releases/news-release-details/dynavax-reports-first-quarter-2025-financial-results-and


Even Management Acknowledges Vaccine Development is Unpredictable When asked if the Tdap program discontinuation provided any read-throughs to other vaccine programs, management acknowledged there were none even though this program also leveraged CpG 1018. -- from those results that you -- that perhaps are any read-through to the other vaccine programs or maybe even any potential vaccine indication that you were contemplating. Any learnings from that? Any data that you can use going forward? TD Cowen 1 Research Associate -through from one program to the other. I think the learning [from discontinuing the Tdap program] is, every program, every antigen, every disease is different, and how and the product that you're building and how 1018 will support it is going to be different. So no, there's no consistent read-through that I would there's any read-through for 1018 here. This is just how 1018 performed with these specific antigens against 1 DVAX CEO Ryan Spencer - so what makes the Board so sure the development efforts will succeed this time? 1 Dynavax 3Q24 earnings call recorded November 7, 2024. 9


Dynavax has yet to offer a clear explanation for why acquiring or developing another vaccine asset will work now, given its lack of success to date. e growth 1 20 years ago for the pandemic flu vaccine is the best risk-adjusted strategy available today. Increasing distractions from the still-unproductive multi-year search for inorganic growth opportunities and a growing portfolio of high-risk vaccine projects are drawing valuable management attention away from Heplisav. Shareholders have been patient. But there is a better path to long-term value creation that includes: Returning excess capital Objectively evaluating results from existing pipeline candidates Out-licensing CpG 1018 to minimize risk but capture upside 1 Dynavax 1Q25 press release filed May 6, 2025. 10


Deep Track Sees a Path to Meaningful Value Creation A superior risk- 1 repurchase shares: indicative value of ~$33 per share in 2030 Step 1: Confirm Strategy Step 2: Capital Allocation Step 3: Lower Share Count Committed focus on Heplisav growth Return excess cash to shareholders Increase per-share value 2 Shares outstanding, ending Heplisav Sales & Consensus Forecast Cash, ending (millions) ($ mm) ($mm) $600 125 $600 $500 100 $400 $400 75 $200 $300 $0 $200 50 FY20 FY22 FY24 FY26 FY28 FY30 FY25 FY26 FY27 FY28 FY29 FY30 FY25 FY26 FY27 FY28 FY29 FY30 Sales Consensus Share repurchases could lower the diluted share count Excess cash today combined with future cash flows If management is focused on the strategic priority of would enable the return of over $1.5 billion to from 124 million to 64 million by the end of 2030 growing market share, sales are expected thereby increasing the value of each share. shareholders through 2030. to reach $600 million by the end of 2030. Focusing on market share and a If the Company did this, Dynavax would still end 2030 This trajectory is consistent with historical revenue systematic buyback program is the most valuable with ~$285 million of cash. growth since 2020. risk-adjusted opportunity available to Dynavax Capital remains available for business development, Board change is needed to prevent a distracting, shareholders today. should a sufficiently attractive opportunity arise. risky, and potentially value-destructive acquisition of an external asset with uncertain returns. 1 Based on assumptions of sales, capital allocation, and outstanding share count as described herein 11 2 Source: Consensus analyst estimates reported by VisibleAlpha, figures retrieved March 14, 2025


Deep Track Sees a Path to Meaningful Value Creation (cont.) THE MATH 1. Heplisav Valuation Projection 2030 consensus sales: $600M $33/share? Valuation multiple: 3.0x current year sales 1 (in line with current 2.7x valuation ) Assuming DVAX share count stays at 120M, and 3 x $600M = $1.8B Heplisav is still worth $1.8B in 2030 2. Estimated Share Count Reduction Before repurchases: 124M After repurchases: 64M The -3B of value in five years. 3. Implied Heplisav Value $1.8B / 64M = ~$28/share 4. Remaining Cash, Equivalents, and Securities Accomplishing this through early-stage clinical Estimated ~$5/share development or acquisitions is unrealistic. $28 + $5 = $33/share 1 Source: FactSet, enterprise value as of May 14, 2025, was $757.53 million. Trailing twelve month revenues were $285.5 million, aggregated from Dynavax financial results reported on May 6, 2025; February 12 20, 2025; November 7, 2024; and August 6, 2024.


Additional Information Vote the WHITE Proxy Card to Refocus Dynavax PROTECT YOUR INVESTMENT IN DYNAVAX candidates Brett Erkman, Jeffrey Farrow, Michael Mullette and Donald Santel on the WHITE proxy card Please visit www.RefocusDVAX.com for additional materials, information and voting instructions 13