Dynavax (NASDAQ: DVAX) topline Z-1018 shingles trial data vs Shingrix

Rhea-AI Filing Summary

Dynavax Technologies Corporation reported that it has released topline results from Part 1 of its Phase 1/2 clinical trial of Z-1018, its novel shingles vaccine candidate. The study is randomized, observer-blinded, and active-controlled, testing Z-1018 head-to-head against Shingrix in adults aged 50 to 69 years. Dynavax also updated its corporate presentation to include information on this Phase 1/2 trial, and both the press release and presentation are provided as exhibits to the report.

Insights

Biotech clinical development analyst

Dynavax shares early clinical data for its shingles vaccine candidate Z-1018 versus Shingrix in a Phase 1/2 trial.

The company has disclosed topline results from Part 1 of a randomized, observer-blinded, active-controlled Phase 1/2 trial of Z-1018, comparing it directly with Shingrix in adults aged 50–69 years. This kind of head-to-head design can provide comparative insights on immune response and safety versus an established vaccine.

The information released is early-stage, reflecting only Part 1 of a Phase 1/2 study, which primarily evaluates safety and immunogenicity rather than definitive protection against shingles. The company also updated its corporate presentation to include these data, suggesting they see them as relevant to the development narrative for Z-1018, while later-phase trials would be needed to fully characterize its potential.

8-K Event Classification

2 items: 7.01, 9.01

2 items

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, and exhibit attachments filed with this report.

Understanding 8-K Material Events →

DYNAVAX TECHNOLOGIES CORP false 0001029142 0001029142 2025-08-21 2025-08-21

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 21, 2025

Dynavax Technologies Corporation

(Exact name of Registrant as Specified in Its Charter)

Delaware		001-34207		33-0728374
(State or Other Jurisdiction of Incorporation)		(Commission File Number)		(IRS Employer Identification No.)

2100 Powell Street, Suite 720
Emeryville, California		94608
(Address of Principal Executive Offices)		(Zip Code)

Registrant’s Telephone Number, Including Area Code: (510) 848-5100

(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:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, $0.001 par value		DVAX		Nasdaq Global Select Market

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 7.01 Regulation FD Disclosure.

On August 21, 2025, Dynavax Technologies Corporation (“Dynavax” or the “Company”) issued a press release announcing 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. The Company has also updated its corporate presentation to include information regarding the Phase 1/2 clinical trial. Copies of the press release and the presentation are attached as Exhibit 99.1 and Exhibit 99.2 to this Current Report on Form 8-K, respectively.

All of the information furnished in this Current Report on Form 8-K, including the accompanying Exhibits, 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 on Form 8-K and in the accompanying exhibits 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.

Exhibit Number		Description
99.1		Press release dated August 21, 2025
99.2		Corporate Presentation
104		Cover Page Interactive Data (embedded within the Inline XBRL document).

SIGNATURES

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
Date: August 21, 2025				By:		/s/ RYAN SPENCER
						RYAN SPENCER Chief Executive Officer

FAQ

What did Dynavax (DVAX) announce in this 8-K filing?

Dynavax announced it has issued a press release with topline results from Part 1 of its Phase 1/2 clinical trial of Z-1018, a novel shingles vaccine candidate, and has updated its corporate presentation with information on this trial.

What is Dynavaxs Z-1018 vaccine candidate mentioned in the filing?

Z-1018 is Dynavaxs novel shingles vaccine candidate being evaluated in a randomized, observer-blinded, active-controlled Phase 1/2 clinical trial in adults aged 50 to 69 years.

How is Z-1018 being tested in the Dynavax clinical trial?

Z-1018 is being tested in a randomized, observer-blinded, active-controlled Phase 1/2 trial conducted head-to-head versus Shingrix in participants aged 50 to 69 years.

Did Dynavax update any investor materials related to the Z-1018 trial?

Yes. Dynavax updated its corporate presentation to include information about the Phase 1/2 clinical trial of Z-1018, and this updated presentation is attached as an exhibit.

Are the Z-1018 trial topline results considered filed financial information?

No. The company states that the information, including the press release and presentation exhibits, is furnished and not deemed "filed" for purposes of certain liability provisions of the securities laws.

Where can investors find more details on Dynavaxs shingles vaccine trial results?

More detailed information is available in the attached press release (Exhibit 99.1) and the updated corporate presentation (Exhibit 99.2) referenced in the report.