Q32 Bio Announces Late-Breaking Presentation of Results from SIGNAL-AA Part A Clinical Trial of Bempikibart in Alopecia Areata at the 2025 American Academy of Dermatology Annual Meeting

-- Oral presentation to highlight Phase 2a Part A results of the randomized, placebo-controlled SIGNAL-AA clinical trial evaluating bempikibart in patients with severe and very severe alopecia areata (AA) --

WALTHAM, Mass., Feb. 28, 2025 /PRNewswire/ -- Q32 Bio Inc. (NASDAQ:QTTB) ("Q32 Bio"), a clinical stage biotechnology company focused on developing biologic therapeutics to restore immune homeostasis, today announced that results from Part A of its SIGNAL-AA Phase 2a clinical trial of bempikibart in patients with alopecia areata (AA) will be presented in a late-breaking oral session at the 2025 American Academy of Dermatology (AAD) Annual Meeting, taking place March 7-11 in Orlando, FL. Bempikibart is a fully human anti-IL-7Rα antibody that re-regulates adaptive immune function by blocking IL-7 and TSLP signaling for the treatment of AA currently being evaluated in a Phase 2 program.

"We are honored that the Phase 2a SIGNAL-AA data from bempikibart was selected for an oral late-breaking presentation at this year's AAD annual meeting, which provides recognition of its promising clinical activity and well-tolerated safety profile. This acknowledgement reinforces our conviction in bempikibart's potential to transform the treatment paradigm for a disease in desperate need of better options," said Jodie Morrison, Chief Executive Officer of Q32 Bio. "The growing enthusiasm in the field underscores our decision to focus on advancing bempikibart in AA, and we look forward to sharing our results."

Oral Presentation Details:

Title: Initial Results from the SIGNAL-AA Study: Randomized Placebo Controlled Phase 2a Trial of a Bempikibart, Novel IL-7/TSLP Bifunctional Receptor Antagonist in Patients with Severe or Very Severe Alopecia Areata

Presenter: Brett King, M.D., Ph.D., of Dermatology Physicians of Connecticut, and former Associate Professor of Dermatology, Yale University School of Medicine

Session Title: S028 - Late-Breaking Research: Session 1

Date & Time: Saturday, March 8, 2025, from 10:36 a.m. to 10:48 a.m. ET

Location: Chapin Theater – Level II

About Q32 Bio

Q32 Bio is a clinical stage biotechnology company whose science targets potent regulators of the adaptive immune system to re-balance immunity in autoimmune and inflammatory diseases.

Q32 Bio is advancing bempikibart (ADX-914), a fully human anti-IL-7Rα antibody that re-regulates adaptive immune function for the treatment of autoimmune diseases being evaluated in a Phase 2 program. The IL-7 and TSLP pathways have been genetically and biologically implicated in driving several T cell-mediated pathological processes in numerous autoimmune diseases.

For more information, visit www.Q32Bio.com.

Availability of Other Information About Q32 Bio

Investors and others should note that we communicate with our investors and the public using our company website www.Q32Bio.com, including, but not limited to, company disclosures, investor presentations and FAQs, Securities and Exchange Commission filings, press releases, public conference call transcripts and webcast transcripts, as well as on X (formerly Twitter) and LinkedIn. The information that we post on our website or on X or LinkedIn could be deemed to be material information. As a result, we encourage investors, the media and others interested to review the information that we post there on a regular basis. The contents of our website or social media shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.

Forward-Looking Statements

This communication contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended, and other federal securities laws. Any statements contained herein which do not describe historical facts, including, among others, our beliefs, observations, expectations and assumptions regarding the topline data from the SIGNAL-AA Phase 2a and the safety, tolerability, clinical activity, potential efficacy and potential benefits of bempikibart; which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements.

Forward-looking statements are based on management's current beliefs and assumptions, which are subject to risks and uncertainties and are not guarantees of future performance. Such risks and uncertainties include, among others, the risk that additional data, or the results of ongoing data analyses, may not support our current beliefs and expectations for bempikibart, future clinical studies, including that Part B of the SIGNAL-AA Phase 2a clinical trial, may not be completed by the first half of 2026 or at all, might be more costly than expected or might not yield anticipated results,  and such other risks and uncertainties identified in the Company's periodic, current and other filings with the U.S. Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 and any subsequent filings with the Commission, which are available at the SEC's website at www.sec.gov. Any such risks and uncertainties could materially and adversely affect the Company's results of operations and its cash flows, which would, in turn, have a significant and adverse impact on the Company's stock price. We caution you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. 

Contacts:

Investors: Brendan Burns

Media: Sarah Sutton

Argot Partners

212.600.1902

[email protected]

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