Adverum Biotechnologies (ADVM) maps Phase 3 ARTEMIS trial enrollment and data timing

Rhea-AI Filing Summary

Adverum Biotechnologies, Inc. filed a current report describing updated timelines for its pivotal Phase 3 ARTEMIS trial evaluating Ixo-vec in wet age-related macular degeneration. The company plans to complete screening for the ARTEMIS trial this month and now anticipates full enrollment in the fourth quarter of 2025. It expects to announce topline data from this Phase 3 study in the first quarter of 2027, giving a clear view of when key clinical results may become available. The report also notes that these statements are forward-looking and subject to significant risks and uncertainties, and that additional risk factors are discussed in the company’s periodic SEC reports.

Insights

Biotech clinical development analyst

Adverum sets concrete Phase 3 ARTEMIS enrollment and data timelines.

Adverum Biotechnologies outlines a clear schedule for its pivotal Phase 3 ARTEMIS trial of Ixo-vec in wet age-related macular degeneration. Screening is planned to complete this month, with full trial enrollment targeted for the fourth quarter of 2025. Topline data are expected in the first quarter of 2027, framing when decisive efficacy and safety results could emerge.

These milestones emphasize that Ixo-vec is in a late-stage, registrational-style program, which is typically a key value driver for a biotech focused on a single lead asset. However, the company highlights that these are forward-looking statements subject to risks and uncertainties, and refers to detailed “Risk Factors” in its periodic SEC reports. Actual timelines and outcomes may vary based on enrollment dynamics, clinical events, and regulatory or operational issues.

The timing of topline data in early 2027 means that subsequent company disclosures will be important for tracking enrollment progress and any protocol or schedule adjustments. The attached press release (Exhibit 99.1) is identified as the primary source for the broader communication, while this report furnishes it without incorporating it into other securities law filings unless specifically referenced.

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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

September 22, 2025

Date of Report (Date of earliest event reported)

Adverum Biotechnologies, Inc.

(Exact name of registrant as specified in its charter)

Delaware		001-36579		20-5258327
(State or other jurisdiction of incorporation)		(Commission File Number)		(I.R.S. Employer Identification No.)

100 Cardinal Way

Redwood City, CA 94063

(Address of principal executive offices, including zip code)

(650) 656-9323

(Registrant’s telephone number, including area code)

N/A

(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 obligations 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		ADVM		Nasdaq Capital 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 September 22, 2025, Adverum Biotechnologies, Inc. (the “Company”) issued a press release. A copy of the press release is furnished as Exhibit 99.1 to this Current Report and incorporated herein by reference.

The information in this Item 7.01, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. The information contained herein and in the accompanying exhibit is not incorporated by reference in any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, regardless of any general incorporation language in such filing, except as shall be expressly set forth by specific reference in such filing.

Item 8.01 Other Events.

The Company announced that it plans to complete screening in the pivotal Phase 3 ARTEMIS trial evaluating Ixo-vec in wet age-related macular degeneration this month. The Company expects full enrollment of the ARTEMIS trial in the fourth quarter of 2025, with topline data from the ARTEMIS trial expected to be announced in the first quarter of 2027.

Cautionary Note Regarding Forward-Looking Statements

This Current Report on Form 8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements regarding the anticipated completion of screening, enrollment and announcement of the topline data results for the ARTEMIS Phase 3 trial. Such forward-looking statements are subject to risks and uncertainties that are often difficult to predict, are beyond the Company’s control, and which may cause results to differ materially from expectations. In addition, for a further discussion of factors that could materially affect the outcome of the Company’s forward-looking statements and its future results and financial condition, see “Risk Factors” in the Company’s periodic reports filed with the SEC. The Company does not undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Item 9.01 Financial Statements and Exhibits.

Exhibit No.		Description
99.1		Press Release dated September 22, 2025.
104		The cover page of this report has been formatted in Inline XBRL.

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

				ADVERUM BIOTECHNOLOGIES, INC.
Date: September 22, 2025				By:		/s/ Laurent Fischer
						Laurent Fischer, M.D.
						President and Chief Executive Officer

FAQ

What did Adverum Biotechnologies (ADVM) disclose in this 8-K?

Adverum Biotechnologies disclosed updated timelines for its pivotal Phase 3 ARTEMIS trial of Ixo-vec in wet age-related macular degeneration, including plans for screening completion, full enrollment, and expected topline data.

When does Adverum Biotechnologies (ADVM) expect to complete screening in the ARTEMIS trial?

The company announced that it plans to complete screening in the pivotal Phase 3 ARTEMIS trial this month, marking a key step toward fully enrolling the study.

What is the expected full enrollment timing for ADVMs Phase 3 ARTEMIS trial?

Adverum Biotechnologies expects full enrollment of the ARTEMIS Phase 3 trial in the fourth quarter of 2025, indicating when patient recruitment is anticipated to be complete.

When are topline data from Adverums ARTEMIS Phase 3 trial expected?

The company expects to announce topline data from the ARTEMIS Phase 3 trial in the first quarter of 2027, which would provide the initial readout on Ixo-vec in this study.

How does Adverum characterize the statements about ARTEMIS timelines?

Adverum states that the ARTEMIS timeline details are forward-looking statements subject to risks and uncertainties and refers readers to the “Risk Factors” section in its periodic SEC reports for further discussion.

What exhibits are included with this Adverum (ADVM) 8-K filing?

The filing includes Exhibit 99.1, a press release dated September 22, 2025, and Exhibit 104, which is the cover page of the report formatted in Inline XBRL.