Full Press Release Details
-- Completed enrollment in Part B of SIGNAL-AA Phase 2a clinical trial and increased trial size to 33 patients based on patient demand; topline data readout expected in mid-2026 --
-- Dosing of patients in Part A open-label extension (OLE) ongoing --
-- Cash and cash equivalents of $49.0 million as of September 30, 2025 expected to provide financial runway into 2027 --
WALTHAM, Mass.,Nov. 13, 2025/PRNewswire/ -- Q32 Bio Inc. (Nasdaq:QTTB) ("Q32 Bio"), a clinical stage biotechnology company focused on developing innovative therapies for alopecia areata (AA) and other autoimmune and inflammatory diseases, today reported financial results for the quarter ended September 30, 2025, and provided recent corporate updates.
"The third quarter was marked by strong execution across our bempikibart development program in AA, culminating in the recent completion of enrollment in Part B of our SIGNAL-AA clinical trial where we increased the trial size to 33 patients due to strong interest from patients and their healthcare providers. We are encouraged by the emerging signs of clinical activity amongst the early-enrolling patients as well as by our preliminary pharmacokinetic data available to date showing that steady state drug concentration is achieved at least nine weeks earlier as compared to Part A due to the inclusion of the loading regimen," said Jodie Morrison, Chief Executive Officer of Q32 Bio. "We are committed to advancing bempikibart as a potentially differentiated therapeutic option for patients with AA, an autoimmune disease with a need for new, safer and more durable treatment alternatives to currently approved agents, and we look forward to sharing our topline data next year."
Third Quarter 2025 and Recent Business Highlights
Financial Results
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 and is focused on developing innovative therapies for alopecia areata and other autoimmune and inflammatory diseases. About 700,000 people in the United States live with alopecia areata1, a disease which has a life-altering impact on patients and limited current treatment options. Q32 Bio is advancing bempikibart (ADX-914), a fully human anti-IL-7Rα antibody that re-regulates adaptive immune function, for the treatment of alopecia areata in an ongoing 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, visitwww.Q32Bio.com.
1National Alopecia Areata Foundation
Availability of Other Information About Q32 Bio
Investors and others should note that Q32 Bio communicates with its investors and the public using its websitewww.Q32Bio.com, including, but not limited to, Q32 Bio's disclosures, investor presentations and FAQs, Securities and Exchange Commission (the "SEC") filings, press releases, public conference call transcripts and webcast transcripts, as well as on X (formerly Twitter) and LinkedIn. The information that Q32 Bio posts on its website or on X or LinkedIn could be deemed to be material information. As a result, Q32 Bio encourages investors, the media and others interested to review the information that it posts there on a regular basis. The contents of Q32 Bio's 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 are forward-looking statements, including, among others, Q32 Bio's beliefs, observations, expectations and assumptions regarding the plan, purpose and timing of Part B of the SIGNAL-AA Phase 2a clinical trial and the anticipated timing of its data, the safety, tolerability, clinical activity, durability, potential efficacy and potential benefits of bempikibart including those observed to date in Part B of the SIGNAL-AA Phase 2a clinical trial, Q32 Bio's expectations and assumptions regarding the timing of the Part A OLE of the SIGNAL-AA Phase 2a clinical trial and the anticipated timing of its completion of dosing and clinical activity, and Q32 Bio's beliefs, expectations and assumptions regarding the future of its business, future plans and strategies, including statements regarding the sufficiency of its cash and cash equivalents to provide financial runway through clinical milestones and into 2027; 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 Q32 Bio's current beliefs and expectations for bempikibart, including with respect to the durability of clinical responses, the risk that ongoing and future clinical studies, including Part B of the SIGNAL-AA Phase 2a clinical trial, may not be completed by mid-2026 or at all, might be more costly than expected or might not yield anticipated results, that Q32 Bio may use its capital resources sooner than currently anticipated and such other risks and uncertainties identified in Q32 Bio's periodic, current and other filings with the SEC, including its Quarterly Report on Form 10-Q for the quarter ended June 30, 2025 and any subsequent filings with the SEC, which are available at the SEC's website atwww.sec.gov. Any such risks and uncertainties could materially and adversely affect Q32 Bio's results of operations and its cash flows, which would, in turn, have a significant and adverse impact on Q32 Bio's stock price. Q32 Bio cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Q32 Bio 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 BurnsArgot Partners212.600.1902[email protected]
Media: David RosenArgot Partners646.461.6387[email protected]
| Q32 BIO INC. | ||||||||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||
| (in thousands, except share and per share amounts) | ||||||||
| (Unaudited) | ||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||
| 2025 | 2024 | 2025 | 2024 | |||||
| Operating expenses: | ||||||||
| Research and development | $ 3,555 | $ 14,346 | $ 15,841 | $ 37,598 | ||||
| General and administrative | 4,022 | 4,468 | 13,136 | 13,978 | ||||
| Total operating expenses | 7,577 | 18,814 | 28,977 | 51,576 | ||||
| Loss from operations | (7,577) | (18,814) | (28,977) | (51,576) | ||||
| Change in fair value of convertible notes | — | — | — | 15,890 | ||||
| Other income | 188 | 1,219 | 1,068 | 3,767 | ||||
| Total other income | 188 | 1,219 | 1,068 | 19,657 | ||||
| Loss before loss from equity method investment | (7,389) | (17,595) | (27,909) | (31,919) | ||||
| Loss from equity method investment | — | — | — | (1,625) | ||||
| Net loss | $ (7,389) | $ (17,595) | $ (27,909) | $ (33,544) | ||||
| Net loss per share—basic | $ (0.60) | $ (1.46) | $ (2.29) | $ (4.01) | ||||
| Net loss per share—diluted | $ (0.60) | $ (1.46) | $ (2.29) | $ (5.60) | ||||
| Weighted-average common shares—basic | 12,240,542 | 12,076,412 | 12,212,081 | 8,360,652 | ||||
| Weighted-average common shares—diluted | 12,240,542 | 12,076,412 | 12,212,081 | 8,810,555 |
| Q32 BIO INC. | ||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | ||||
| (in thousands) | ||||
| (Unaudited) | ||||
| September 30,2025 | December 31,2024 | |||
| Assets | ||||
| Cash and cash equivalents | $ 49,039 | $ 77,965 | ||
| Equity investment | — | 2,600 | ||
| Right-of-use asset, operating leases | 5,258 | 5,722 | ||
| Restricted cash and restricted cash equivalents | 647 | 647 | ||
| Other assets | 2,840 | 5,398 | ||
| Total assets | $ 57,784 | $ 92,332 | ||
| Liabilities and stockholders' equity (deficit) | ||||
| Accounts payable, accrued expenses and other current liabilities | $ 4,878 | $ 10,468 | ||
| CVR liability | — | 2,900 | ||
| Lease liability, net of current portion | 5,121 | 5,636 | ||
| Venture debt | 11,233 | 12,653 | ||
| Other noncurrent liabilities | 55,000 | 55,000 | ||
| Stockholders' equity (deficit) | (18,448) | 5,675 | ||
| Total liabilities and stockholders' equity (deficit) | $ 57,784 | $ 92,332 |