Q32 Bio Reports Third Quarter 2026 Financial Results and Provides Corporate Update

An approximately $200.0 million gross offering added funding, while quarterly research and administrative expenses increased year over year.

Rhea-AI Summary

Q32 Bio (Nasdaq: QTTB) reported third-quarter financial results and outlined plans to advance bempikibart into a registration-directed alopecia areata program. Quarterly net loss was $8.922 million, versus $7.389 million a year earlier, while loss per share narrowed to $0.26 from $0.60. Cash and cash equivalents reached $289.6 million at September 30 following a July offering raising approximately $200.0 million gross.

In the open-label Phase 2a SIGNAL-AA Part B trial, the prespecified modified analysis showed a 35.3% mean reduction in scalp hair-loss scores at Week 36. Responses were maintained or deepened during 16 weeks off treatment, with no new safety signals. Q32 expects registration-directed development to start in 1H 2027, subject to fourth-quarter regulatory discussions, and extension data in 2H 2027. It believes available cash can fund operations through planned Phase 3 topline results.

14 points · 2 major

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1 major · 7 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Major pointJuly public offering raised approximately $200.0 million gross, before underwriting discounts, commissions and offering expenses. 77% of market cap
• Major pointSIGNAL-AA Part B primary endpoint showed 35.3% mean scalp hair-loss score reduction at Week 36 in the prespecified modified analysis.
• Moderate point16-week off-drug follow-up showed maintained or deepened responses, supporting potential less frequent maintenance dosing.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Registration-directed development in severe or very severe alopecia areata is expected to begin in 1H 2027.
• Minor point. Forward-looking: it has not happened yet and may not happen.Cash and cash equivalents of $289.6 million at September 30 are expected to fund operations through planned Phase 3 topline results.

9 minor points

• Minor point80% scalp hair coverage was achieved at Week 36 by 40.0% in the modified analysis and 30.3% of all enrolled patients.
• Minor pointBempikibart was generally well-tolerated, with no new safety signals; biomarker and biopsy findings supported its mechanism.
• Minor point. Forward-looking: it has not happened yet and may not happen.Open-label extension dosing remains ongoing; Q32 anticipates data in the second half of 2027.
• Minor pointExpanded alopecia areata populations and additional inflammatory indications are being evaluated as development opportunities.
• Minor pointADX-914-XL continues in preclinical development, targeting an extended dosing schedule.
• Minor pointNine-month research and development expenses declined to $12.626 million from $15.841 million a year earlier.
• Minor pointNine-month net loss narrowed to $25.477 million, or $1.11 per share, from $27.909 million, or $2.29.
• Minor pointOther income, net rose to $1.738 million quarterly and $2.170 million year-to-date, versus $0.188 million and $1.068 million.
• Minor pointVenture debt was zero at September 30, 2026, versus $9.708 million at December 31, 2025.

Negative

• Major pointCommon stock and pre-funded warrants issued in the July public offering dilute existing holders.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Registration-directed program initiation remains subject to planned fourth-quarter 2026 regulatory discussions.
• Moderate pointQuarterly net loss widened to $8.922 million from $7.389 million, although per-share loss narrowed to $0.26 from $0.60.
• Minor pointSIGNAL-AA Part B was open-label and enrolled 33 patients with severe or very severe alopecia areata.
• Minor pointQuarterly research and development expenses increased to $5.149 million from $3.555 million a year earlier.

2 minor points

• Minor pointGeneral and administrative expenses increased to $5.511 million quarterly and $14.874 million year-to-date, versus $4.022 million and $13.136 million.
• Minor pointNine-month debt-extinguishment loss was $0.147 million, versus none in the prior-year period.

Key Figures

Cash and cash equivalents: $289.6 million Trial participants: 33 patients Mean SALT score reduction: 35.3% +5 more

Cash and cash equivalents

$289.6 million

As of September 30, 2026

Trial participants

33 patients

SIGNAL-AA Part B; severe or very severe alopecia areata

Mean SALT score reduction

35.3%

Week 36; prespecified mITT analysis

SALT-20 response

40.0% mITT; 30.3% ITT

Week 36

Off-drug follow-up

16 weeks

After the 36-week treatment period in Part B

Net loss

$8.9 million

Three months ended September 30, 2026

Net loss per share

$0.26

Basic and diluted; three months ended September 30, 2026

Planned registration-directed program

First half of 2027

For severe or very severe alopecia areata; subject to planned regulatory discussions

Previous Earnings Reports

1 past event · Latest: Aug 05

Same Type 1 event

1. Aug 05

   Earnings report

   24h Move

   +2.1%

   Reported $106.3 million cash and expected funding through planned Phase 3 topline results.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

open-label extension, modified intent-to-treat, intent-to-treat, primary endpoint

4 terms

open-label extension medical

"SIGNAL-AA Part B open-label extension (OLE) ongoing"

An open-label extension is a continuation of a clinical trial where all participants and researchers know which treatment is being given, often after an initial blinded phase. It allows further study of a drug's long-term safety and effectiveness. For investors, it can indicate ongoing interest and confidence in a product's potential, influencing perceptions of its future value.

modified intent-to-treat medical

"prespecified modified intent-to-treat ("mITT") analysis"

A modified intent-to-treat (mITT) population is a version of a clinical trial analysis that includes most but not all people who were originally randomized, typically excluding those who never received the study treatment or lacked key baseline data. For investors, mITT matters because it can change how effective or safe a drug appears compared with a strict all-randomized analysis; thinking of it like judging a recipe only from cooks who actually made the dish helps explain how the choice of who is counted can shift results and influence regulatory and market reactions.

intent-to-treat medical

"intent-to-treat ("ITT") analysis of all enrolled patients"

A method for analyzing clinical trial results that counts every participant in the group they were originally assigned to, regardless of whether they completed the treatment or followed instructions. Like grading a class by the seats students were assigned rather than who finished the exam, it preserves the trial’s original comparisons and gives a realistic, often more conservative, estimate of how a drug or device performs in real-world use — information investors use to judge reliability and regulatory risk.

primary endpoint medical

"clinically meaningful efficacy data on the primary endpoint"

The primary endpoint is the single main result a clinical study is designed to measure to decide if a treatment works, like the finish line in a race that tells you who won. Investors care because meeting or missing this goal drives regulatory decisions, future sales expectations and stock value — it turns trial data into a clear yes-or-no signal about a drug’s commercial prospects.

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-- Presented additional 36-week results and 16-week off-drug findings from Part B of the SIGNAL-AA clinical trial of bempikibart in late-breaking oral and poster presentations at EADV Congress 2026; data supports further development of bempikibart as a chronic treatment in AA --

-- Robust durability, including maintenance and deepening of response, observed through the 16-week off-drug period in Part B supporting potential for less frequent, chronic maintenance dosing --

-- SIGNAL-AA Part B open-label extension (OLE) ongoing; data expected in 2H'2027 --

-- Registration-directed program evaluating bempikibart in patients with severe or very severe AA expected to initiate in 1H'2027 subject to planned regulatory discussions this quarter --

-- Strengthened leadership team including appointments of José Trevejo, M.D., Ph.D., as Chief Medical Officer and Ellie Hershberger, Pharm.D., as Chief Development Officer --

-- Cash and cash equivalents of $289.6 million as of September 30, 2026 expected to provide financial runway through Phase 3 topline results from planned registration-directed program --

WALTHAM, Mass., Nov. 4, 2026 /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, 2026, and provided recent corporate updates.

"The third quarter brought continued momentum for Q32 Bio and our bempikibart program. We shared encouraging SIGNAL-AA Part B results in late-breaking oral and poster presentations at EADV, highlighting bempikibart's clinically meaningful efficacy data at Week 36 and ability to induce durable responses that were maintained or deepened through the 16-week off-drug period, supporting the potential for less frequent, chronic maintenance dosing," said Jodie Morrison, Chief Executive Officer of Q32 Bio. "We believe our data demonstrates the potential for bempikibart to become a first-line standard of care option for patients with alopecia areata. We are pleased to welcome José and Ellie to lead the advancement of bempikibart into late-stage development and have made key senior appointments spanning clinical operations, clinical strategy and medical affairs, and regulatory affairs. With a strong balance sheet, we believe we are well positioned to rapidly advance into a registration-directed program in severe or very severe alopecia areata in the first half of 2027 following planned regulatory discussions this quarter, as well as in other autoimmune and inflammatory indications."

Third Quarter 2026 and Recent Business Highlights

• Presented additional 36-week results and 16-week off-drug findings from Part B of the SIGNAL-AA clinical trial at EADV Congress 2026. In September 2026, Q32 Bio presented results from Part B of the SIGNAL-AA Phase 2a clinical trial in a late-breaking oral presentation and a poster presentation at the European Academy of Dermatology and Venereology ("EADV") Congress 2026 in Vienna, Austria. Part B is an open-label clinical trial evaluating bempikibart, a fully human anti-IL-7Rα antibody designed to re-regulate adaptive immune function by blocking IL-7 and TSLP signaling, in 33 patients with severe or very severe AA. Patients are treated with bempikibart for 36 weeks followed by a 16-week off-drug follow-up period before optional enrollment in the open-label extension ("OLE"). In Part B at Week 36, bempikibart demonstrated clinically meaningful efficacy data on the primary endpoint with a mean percent reduction in Severity of Alopecia Tool ("SALT") score from baseline of 35.3% in the prespecified modified intent-to-treat ("mITT") analysis. Additionally, 40.0% of patients achieved a SALT-20 (80% of scalp hair coverage) response at Week 36 in the mITT analysis and 30.3% of patients achieved a SALT-20 response at Week 36 in the intent-to-treat ("ITT") analysis of all enrolled patients. In the 16-week off-drug follow-up period, bempikibart demonstrated robust durability, including maintenance and deepening of response, supportive of less frequent, chronic maintenance dosing after an initial treatment period. Biomarker results and biopsy findings supported bempikibart's mechanism of action, and bempikibart was generally well-tolerated, consistent with prior studies, with no new safety signals. Q32 Bio previously announced topline results from Part B of SIGNAL-AA in July 2026.

• SIGNAL-AA Part B OLE remains ongoing. Following completion of the Part B 36-week treatment period and 16-week off-drug follow-up period, eligible patients enrolled in the Part B OLE. Dosing remains ongoing in the OLE. Analysis from the Part B 16-week off-drug follow-up period and OLE will help inform long-term chronic maintenance regimens, which could include monthly, bi-monthly or quarterly dosing, which will be evaluated in future studies. Q32 Bio anticipates data from the Part B OLE in the second half of 2027.

• Registration-directed program evaluating bempikibart in patients with severe or very severe AA expected to initiate in the first half of 2027 and additional development opportunities being evaluated. Q32 Bio plans to advance bempikibart into a registration-directed program for patients with severe or very severe AA in the first half of 2027 subject to planned regulatory discussions in the fourth quarter of 2026. Additionally, based on clinical results as well as changes on biomarkers supportive of bempikibart's bifunctional mechanism, Q32 Bio is evaluating opportunities for bempikibart in expanded AA populations as well as in additional immunology and inflammation ("I&I") indications.

• Strengthened leadership team including appointments of Chief Medical Officer and Chief Development Officer, as well as key senior leaders overseeing clinical operations, clinical strategy and medical affairs and regulatory affairs. In September 2026, Q32 Bio appointed José Trevejo, M.D., Ph.D., as Chief Medical Officer and Ellie Hershberger, Pharm.D., as Chief Development Officer. Dr. Trevejo is a physician-scientist and biotechnology executive with over 20 years of experience spanning dermatology and late-stage clinical development. Dr. Hershberger is a drug development leader with over 30 years of experience spanning late-stage development operations and regulatory strategy. In addition to the appointments of Dr. Trevejo and Dr. Hershberger, Q32 Bio has continued to build out its team with key clinical operations, clinical strategy and medical affairs and regulatory affairs appointments.

• Half-life extended fully human anti-IL-7Rα program, ADX-914-XL, continues in preclinical development. Developed using half-life extension technology, ADX-914-XL is designed to provide the clinical activity and safety profile observed to date with bempikibart while offering an extended dosing schedule.

• Completed $200.0 million public offering. In July 2026, Q32 Bio completed a public offering of common stock and pre-funded warrants, raising gross proceeds of approximately $200.0 million, before deducting underwriting discounts and commissions and offering expenses payable by Q32 Bio.

Financial Results

• Cash and cash equivalents were $289.6 million as of September 30, 2026. Q32 Bio believes its cash and cash equivalents as of September 30, 2026 are sufficient to fund operations through topline Phase 3 results from its planned registration-directed program evaluating bempikibart in patients with severe or very severe AA.

• Research and development expenses were $5.1 million for the three months ended September 30, 2026, compared to $3.6 million for the three months ended September 30, 2025. The increase was primarily due to higher bempikibart clinical and manufacturing costs as compared to the prior year, as well as preclinical development costs for ADX-914-XL.

• General and administrative expenses were $5.5 million for the three months ended September 30, 2026, compared to $4.0 million for the three months ended September 30, 2025. The increase was primarily due to higher stock-based compensation expense and other employee-related costs as compared to the prior year.

• Net loss was $8.9 million, or $0.26 basic and diluted net loss per share, for the three months ended September 30, 2026, compared $7.4 million, or $0.60 basic and diluted net loss per share, for the three months ended September 30, 2025.

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, visit www.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 website www.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, including, among others, Q32 Bio's beliefs, observations, expectations and assumptions regarding the results from the Part B of the SIGNAL-AA Phase 2a clinical trial, the safety, tolerability, clinical activity including biomarker data, potential efficacy and potential benefits of bempikibart, plans and expectations for Part B of the SIGNAL-AA Phase 2a clinical trial, the anticipated timing of data results, safety, tolerability and findings from the potential Part B OLE, the potential of advancing bempikibart in other autoimmune and inflammatory conditions, the expectations surrounding the potential, safety, efficacy, and regulatory and clinical progress of Q32 Bio's product candidates, including bempikibart, and anticipated milestones, timing of anticipated registrational trials, data readouts and timing, the plans and timing of the preclinical development of ADX-914-XL, the United States AA market size and potential commercial opportunities, Q32 Bio's expectations regarding the strength of its leadership team, and Q32 Bio's beliefs, expectations and assumptions regarding the future of its business, future plans and strategies, including statements regarding sufficiency of its cash and cash equivalents to provide financial runway through topline Phase 3 results from its planned registration-directed program evaluating bempikibart in patients with severe or very severe AA, among others, are forward-looking statements; which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements.

Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "anticipate," "plan," "likely," "believe," "estimate," "project," "intend," and other similar expressions among others. Statements that are not historical facts are 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 might be more costly than expected or might not yield anticipated results, that Q32 Bio may use its capital resources sooner than currently anticipated, Q32 Bio's expectations regarding the sufficiency of its cash and cash equivalents to provide financial runway and that Q32 Bio may need additional funding to complete clinical studies, which may not be available on favorable terms or at all 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, 2026 and any subsequent filings with the SEC, which are available at the SEC's website at www.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 Burns
Senior Director, Investor Relations and Corporate Communications
Q32 Bio
bburns@q32bio.com 

Media: David Rosen
Argot Partners
646.461.6387
david.rosen@argotpartners.com

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,
		2026		2025		2026		2025
Operating expenses:
Research and development		$                   5,149		$                   3,555		$                 12,626		$                 15,841
General and administrative		5,511		4,022		14,874		13,136
Total operating expenses		10,660		7,577		27,500		28,977
Loss from operations		(10,660)		(7,577)		(27,500)		(28,977)
Loss on extinguishment of debt		—		—		(147)		—
Other income, net		1,738		188		2,170		1,068
Total other income		1,738		188		2,023		1,068
Net loss and comprehensive loss		$                 (8,922)		$                 (7,389)		$               (25,477)		$               (27,909)
Net loss per share—basic and diluted		$                    (0.26)		$                    (0.60)		$                    (1.11)		$                    (2.29)
Weighted-average common shares—basic and diluted		34,022,755		12,240,542		22,912,875		12,212,081

 

Q32 BIO INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
		September 30, 2026		December 31, 2025
		(Unaudited)
Assets
Cash and cash equivalents		$                 289,587		$                   48,297
Right-of-use asset, operating leases		4,601		5,100
Restricted cash and restricted cash equivalents		647		647
Other assets		2,366		7,732
Total assets		$                 297,201		$                   61,776
Liabilities and stockholders' equity
Accounts payable, accrued expenses and other current liabilities		$                     5,167		$                     5,111
Lease liability, net of current portion		4,364		4,943
Venture debt		—		9,708
Stockholders' equity		287,670		42,014
Total liabilities and stockholders' equity		$                 297,201		$                   61,776

 

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SOURCE Q32 Bio

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Q32 Bio's SIGNAL-AA Part B trial show at Week 36?

Bempikibart produced a 35.3% mean reduction from baseline in the Severity of Alopecia Tool score, a scalp hair-loss measure, in the prespecified modified intent-to-treat analysis. A SALT-20 response, representing 80% scalp hair coverage, occurred in 40.0% of that analysis group and 30.3% of all enrolled patients.

When does Q32 Bio expect to start its bempikibart registration-directed program?

Q32 expects to begin the program for severe or very severe alopecia areata in the first half of 2027, subject to planned regulatory discussions in the fourth quarter of 2026.

What maintenance dosing schedules is Q32 Bio considering for bempikibart?

Potential long-term maintenance regimens could include monthly, bi-monthly or quarterly dosing, to be evaluated in future studies. Analysis of the 16-week off-drug follow-up and ongoing open-label extension will help inform those regimens; these schedules are not established treatment regimens.