Q32 Bio Presents Results from Part B of the SIGNAL-AA Clinical Trial of Bempikibart in Alopecia Areata in a Late-Breaker at the European Academy of Dermatology and Venereology Congress 2026

Q32 Bio expects extension-study data in the second half of 2027 to help inform a potential long-term maintenance regimen.

Rhea-AI Summary

Q32 Bio (QTTB) presented additional Phase 2a bempikibart results showing hair regrowth and off-treatment response durability in severe alopecia areata.

The open-label SIGNAL-AA Part B trial enrolled 33 patients. At Week 36, mean reduction in the scalp hair-loss score, SALT, was 35.3% in the modified intent-to-treat analysis. SALT-20, representing 80% scalp hair coverage, was achieved by 40.0% (10/25) in that analysis and 30.3% (10/33) in the full intent-to-treat population. Among 12 patients with hair growth entering follow-up, all maintained response through 16 weeks off treatment and 42% improved further. No new safety signals or treatment-related serious or Grade 3 or higher adverse events occurred.

Q32 Bio plans a registration-directed program in the first half of 2027, subject to planned regulatory discussions in the second half of 2026.

18 points · 0 major

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

Positive

• Moderate pointWeek 36 mean SALT reduction was 35.3% from baseline in the modified intent-to-treat analysis.
• Moderate pointWeek 36 SALT-20 response reached 40.0% (10/25) in modified intent-to-treat and 30.3% (10/33) in intent-to-treat analyses.
• Moderate pointResponse maintenance occurred in 100% of 12 patients with Week 36 hair growth; 42% improved further.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Registration-directed development is planned for the first half of 2027 in severe or very severe alopecia areata.
• Minor pointWeek 36 SALT30 response reached 44.0% (11/25) in modified intent-to-treat and 33.3% (11/33) in intent-to-treat analyses.

13 minor points

• Minor pointWeek 36 SALT50 response reached 44.0% (11/25) in modified intent-to-treat and 33.3% (11/33) in intent-to-treat analyses.
• Minor pointSALT-20 responses occurred across severe and very severe disease, IgE levels, and episode-duration subgroups.
• Minor pointMean SALT reductions were 48.3% in prior JAK responders, 4.8% in prior non-responders, and 44.1% in JAK-naïve patients.
• Minor point16-week off-drug responses among 18 patients were 44% SALT-20, 61% SALT30, and 50% SALT50.
• Minor pointOff-drug hair regrowth included one complete response, two improvements to SALT-10, and one latent responder reaching SALT-20.
• Minor pointLoading regimen achieved steady-state drug concentrations approximately 10 weeks earlier than in Part A.
• Minor pointBiomarker findings included reduced T-cells and inflammatory markers; biopsies showed fewer inflammatory infiltrates and more active-growth follicles.
• Minor pointAnti-drug antibodies were negligible, with no impact on drug concentration behavior.
• Minor pointSafety findings showed no new signals and no treatment-related serious or Grade 3 or higher adverse events.
• Minor pointAbsolute lymphocyte count reduction flattened at Weeks 24 to 28, with no correlation to infection events.
• Minor point. Forward-looking: it has not happened yet and may not happen.Extension enrollment and dosing remain ongoing; Q32 Bio anticipates data in the second half of 2027.
• Minor point. Forward-looking: it has not happened yet and may not happen.Potential maintenance dosing could be monthly, bi-monthly or quarterly, to be evaluated in future studies.
• Minor point. Forward-looking: it has not happened yet and may not happen.Expanded development opportunities are being evaluated in additional alopecia areata populations and other autoimmune and inflammatory indications.

Negative

• Minor pointRegistration-directed program remains subject to planned regulatory discussions in the second half of 2026.
• Minor pointInjection site reactions occurred in 36.3% of patients and 4% of dose administrations; all were mild and resolved without intervention.

News Explained

Alongside the trial results, Q32 Bio says the Part B open-label extension is ongoing and its data, expected in the second half of 2027, will inform long-term maintenance dosing, which could be monthly, bi-monthly or quarterly.

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Details

Market move: QTTB -3.97% vs previous close. Phase 2a clinical data

-13.5% Trough in 5 min

$8.57 – $11.68 Day Range

$272.44M Market Cap

On Sep 30, the day this news came out, the latest delayed price for QTTB is 3.97% below the previous close. Argus tracked a trough of -13.5% from its starting point during tracking. Our momentum scanner has recorded 28 alerts for this stock so far that day. The latest delayed price is $9.15. Relative volume is exceptionally heavy at 45.5x the average.

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Key Figures

Mean SALT score reduction: 35.3% SALT-20 response: 40.0% (10/25) mITT; 30.3% (10/33) ITT Off-drug SALT-20 response: 44% +5 more

Mean SALT score reduction

35.3%

Week 36, mITT analysis

SALT-20 response

40.0% (10/25) mITT; 30.3% (10/33) ITT

Week 36

Off-drug SALT-20 response

44%

16-week off-drug follow-up

Off-drug SALT30 response

61%

16-week off-drug follow-up

Off-drug SALT50 response

50%

16-week off-drug follow-up

Maintained response

100%

Among 12 patients with hair growth at Week 36 who entered off-drug follow-up

Deepened response

42%

Among 12 patients with hair growth at Week 36 who entered off-drug follow-up

Registration-directed program planned

First half of 2027

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

Previous Clinical trial Reports

2 past events · Latest: Jul 13

Same Type 2 events

1. Jul 13

   Phase 2a results

   24h Move

   +90.7%

   Part B topline established 35.3% mean SALT reduction and Week 36 response rates.

2. Mar 08

   Part A results

   24h Move

   -7.2%

   Part A reported SALT reductions and continued responses after dosing ended.

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

Key Terms

pharmacokinetic, pharmacodynamic, anti-drug antibody, modified intent-to-treat, +1 more

5 terms

pharmacokinetic medical

"Pharmacokinetic ("PK"), Pharmacodynamic ("PD"), and Anti-Drug Antibody ("ADA") Profile"

Pharmacokinetic describes how a drug moves through and leaves the body — how it is absorbed, spread to tissues, broken down and excreted — like tracking a package from pickup to delivery and disposal. For investors, these properties determine effective dose, safety risks, how often a medicine must be taken, and how reliably it works, which in turn influence clinical trial success, regulatory approval chances, production complexity and a drug’s commercial value.

pharmacodynamic medical

"Pharmacokinetic ("PK"), Pharmacodynamic ("PD"), and Anti-Drug Antibody ("ADA") Profile"

Pharmacodynamic describes how a drug acts on the body — the biological effects it produces, how strong those effects are, and how long they last. For investors, pharmacodynamic data show whether a treatment actually works and at what dose, shaping expectations about a drug’s safety, effectiveness, regulatory success and market potential; think of it like testing how well a key turns a lock and whether it reliably opens the door.

anti-drug antibody medical

"Pharmacokinetic ("PK"), Pharmacodynamic ("PD"), and Anti-Drug Antibody ("ADA") Profile"

Antibodies produced by a patient’s immune system that recognize and bind a therapeutic biological drug (such as a recombinant protein, monoclonal antibody, or enzyme). These immune proteins can block the drug’s intended activity, speed its removal from the body, or cause side effects, so they affect how well a treatment works, its safety profile, dosing needs, and regulatory or commercial prospects—like neutralizers that reduce a medicine’s intended effect.

modified intent-to-treat medical

"The prespecified primary efficacy analysis was evaluated on the basis of mean percentage change from baseline in SALT scores in the modified intent-to-treat ("mITT") population."

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.

open-label extension medical

"before optional enrollment in the open-label extension ("OLE")"

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.

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-- Clinically meaningful efficacy data observed on primary and key secondary endpoints at Week 36 --

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

-- Mechanism of action supported by biomarker results and biopsy findings --

-- Generally well-tolerated safety profile, consistent with prior studies, with no new safety signals --

-- Data supports further development of bempikibart as a chronic treatment in alopecia areata; Q32 Bio intends to advance a registration-directed program in the first half of 2027 --

WALTHAM, Mass., Sept. 30, 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 announced additional 36-week results and initial findings from the 16-week off-drug period from Part B of the SIGNAL-AA Phase 2a clinical trial evaluating bempikibart in patients with severe or very severe AA. These results were presented across a late-breaking oral and poster presentation at the European Academy of Dermatology and Venereology ("EADV") Congress 2026. Q32 Bio previously announced topline results from this trial in July 2026. Bempikibart is a fully human anti-IL-7Rα antibody designed to re-regulate adaptive immune function by blocking IL-7 and TSLP signaling.

"We're proud to share our compelling SIGNAL-AA Part B results with the scientific community in late-breaking oral and poster presentations at EADV. We are committed to developing bempikibart as a highly differentiated, targeted treatment option for patients with alopecia areata and believe our Part B results demonstrate meaningful progress on that commitment," said Jodie Morrison, Chief Executive Officer of Q32 Bio. "Bempikibart's robust efficacy data and durability observed across the 36-week treatment period and 16-week off-drug period in both JAK inhibitor-experienced and JAK inhibitor-naïve patients, changes on biomarkers supportive of its bifunctional mechanism, and its favorable safety and tolerability profile support its continued development in a registration-directed program in patients with severe or very severe alopecia areata as well as in expanded alopecia areata populations and other autoimmune and inflammatory indications."

"Patients and physicians currently lack a treatment option for this complex, immune driven disease that combines robust efficacy, a favorable safety profile that excludes black box warnings and other frequent monitoring requirements, and delivers durable control supporting less frequent, chronic maintenance dosing," said Arash Mostaghimi, M.D., M.P.A., M.P.H., Associate Professor of Dermatology and Vice Chair of Clinical Trials and Innovation, Brigham and Women's Hospital, Harvard Medical School. "The SIGNAL-AA Part B results support the potential of bempikibart to address this unmet need and become a standard of care, first-line option for patients with alopecia areata, and I look forward to results from future clinical trials."

Results from Part B of the SIGNAL-AA Program:

The Part B portion of the SIGNAL-AA program is an open-label clinical trial building upon the previously completed Part A, which established proof-of-concept of bempikibart in AA. In Part B, bempikibart is being evaluated in 33 patients with severe or very severe AA (baseline Severity of Alopecia Tool ("SALT") scores of 50-100) with a maximum duration of current episode of four years. Enrollment amongst patients with prior exposure to JAK inhibitor ("JAKi") therapy was allowed; amongst the 33 enrolled patients, 36.4% had previously been treated with oral JAKis.

Total enrollment exceeded the initial target due to patient demand. In Part B, patients are treated with bempikibart for 36 weeks, with 16-week off-drug follow-up through Week 52 before optional enrollment in the open-label extension ("OLE"). Dosing includes an initial loading regimen of 200mg of bempikibart dosed weekly for four doses, followed by continued dosing of 200mg every-other-week over a 32-week period, for a total dosing period of 36 weeks. Across both regimens, bempikibart was administered subcutaneously ("SC").

The prespecified primary efficacy analysis was evaluated on the basis of mean percentage change from baseline in SALT scores in the modified intent-to-treat ("mITT") population. Additional prespecified efficacy analyses included the proportion of patients achieving various relative and absolute SALT improvements including SALT-20 (80% of scalp hair coverage), SALT₃₀ (30% improvement in SALT score from baseline), and SALT₅₀ (50% improvement in SALT score from baseline) responses at Week 36. Patients were then followed through the off-drug period to Week 52.

Highlights from the EADV Congress 2026 late-breaking and poster presentations include:

Results from the 36-Week Treatment Period in Part B of the SIGNAL-AA Program:

Bempikibart demonstrated clinically meaningful efficacy data on primary and key secondary endpoints at Week 36 supporting its advancement into a registration-directed program.

• Mean percent reduction in SALT score from baseline of 35.3% in the mITT analysis.
  
  
• 40.0% (10/25) of patients in the mITT analysis and 30.3% (10/33) of patients in the intent-to-treat ("ITT") analysis achieved a SALT-20 response.
  
  
• In addition to SALT-20 response being observed in patients with both severe and very severe disease, it was also observed in both IgE-high and IgE-low patients and in both patients with greater than and less than two-year duration of episode.
  
  
• 44.0% (11/25) of patients in the mITT analysis and 33.3% (11/33) of patients in the ITT analysis achieved SALT₃₀ response. 
  
  
• 44.0% (11/25) of patients in the mITT and 33.3% (11/33) of patients in the ITT analysis achieved SALT₅₀ response.
  
  
• In the mITT analysis, 10 patients had received an oral JAKi before enrolling. Of these, four had responded to their most recent JAKi (defined as at least 30% improvement in SALT score) and six had not. Mean percent reduction in SALT score from baseline was 48.3% in prior JAK responders, compared with 4.8% in prior JAK non-responders. Reduction in mean SALT score of JAK-naïve patients was 44.1%.

Results from the 16-Week Off-Drug Follow-Up Period in Part B of the SIGNAL-AA Program:

Bempikibart demonstrated robust durability, with maintenance and deepening of response observed, in the 16-week off-drug follow-up period.

• In total, 18 patients entered the 16-week off-drug period. At the 16-week off-drug time point, 44% of patients achieved a SALT-20 response, 61% achieved SALT₃₀ response, and 50% achieved SALT₅₀ response.
  
  
• Of the patients who entered the off-drug follow-up period, 12 patients had demonstrated hair growth by the end of the treatment period at Week 36. Maintenance of response (with maintenance defined as a less than 20-point SALT score worsening from the last on-treatment value) was observed in 100% of these patients and deepening of response was observed in 42% of these patients. Mean SALT score in these patients remained stable through 16-weeks off-drug.
  
  
• In the 16-week off-drug follow-up period, one patient who achieved a SALT-10 at Week 36 achieved complete hair growth (SALT = 0) and two additional patients who achieved SALT-20 at Week 36 had a deepening of response and achieved a SALT-10.
  
  
• One latent responder during the 36-week treatment period converted to a response, achieving a SALT-20, at the end of the 16-week off-drug period.

"We are excited to show once again that bempikibart was able to induce deep, durable responses in severe and very severe alopecia areata. Responses were maintained and deepened through the 16-week off-drug period, and one latent responder converted to SALT-20 after stopping treatment, similar to what we saw in Part A, demonstrative of the potential for even greater clinical impact with continued dosing," said José Trevejo, M.D., Ph.D., Chief Medical Officer of Q32 Bio. "We believe these data support a less frequent, chronic maintenance dosing regimen once patients respond. We look forward to exploring a potential maintenance regimen in our open-label extensions as we move rapidly into registrational studies in the first half of 2027."

Pharmacokinetic ("PK"), Pharmacodynamic ("PD"), and Anti-Drug Antibody ("ADA") Profile:

Bempikibart demonstrated a favorable PK, PD and ADA profile in Part B.

• PK data from Part B support the loading dose regimen had its intended effect, achieving steady state concentrations approximately 10 weeks earlier than in Part A.
  
  
• Expected reductions in CD3+ T-cells were observed, with on-mechanism reductions in four T-effector cytokines assessed at baseline and Weeks 24 and 36. Patients in the upper-tier at baseline showed meaningful reductions in IFNγ, IL-17, and IL-6. CXCL10, a downstream marker of IFNγ activity, decreased meaningfully in responders versus non-responders.
  
  
• Substantial reductions in biomarkers of Th2, including TARC, IgE and eosinophils.
  
  
• Post-treatment biopsies showed reduced CD3+/CD8+ infiltrates around hair follicles and increased presence of anagen follicles supportive of active hair growth.
  
  
• Negligible ADA was observed with no impact on PK.

"Reductions in Th1 and Th2 biomarkers observed across Part B further demonstrate the potential of bempikibart's unique IL-7 and TSLP inhibitory mechanism to translate into clinical benefit for patients, while biopsy results provide strong evidence of bempikibart's potential to inhibit local inflammation and restore immune homeostasis in the hair follicle," said Shelia Violette, Ph.D., Co-Founder and Chief Scientific Officer of Q32 Bio. "These results strengthen our conviction in the potential to deliver a meaningful treatment option to patients with alopecia areata and provide strong rationale for advancing bempikibart development in other autoimmune and inflammatory conditions where IL-7 and TSLP play a role."

Safety and Tolerability Results:

Bempikibart was observed to have a generally well-tolerated safety profile in SIGNAL-AA Part B, consistent with prior studies. No new safety signals were observed. There were no serious adverse events or Grade 3 or higher adverse events related to treatment. The most common treatment-emergent adverse event was injection site reaction ("ISR") (36.3%) which were primarily singular events, with ISR incidence of 4% across all Part B dose administrations. All ISRs reported were mild and resolved with no intervention, with the majority resolving within a day. On-target reduction in absolute lymphocyte count flattened at Weeks 24 to 28 with no correlation to infection events.

The presentations will be available in the "Presentations and Publications" section of the Q32 Bio website following the formal EADV presentation.

Bempikibart Development Program in AA:

Following completion of the Part B 36-week treatment period and 16-week off-drug follow-up period, eligible patients can enroll in an OLE. Enrollment and dosing remain ongoing in the OLE. Analysis from the Part B 16-week off-drug follow-up period and OLE will inform the bempikibart long-term chronic maintenance regimen, 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.

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 second half of 2026. Additionally, based on results observed, Q32 Bio is evaluating opportunities for bempikibart in expanded AA populations as well as in other autoimmune and inflammatory indications.

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, and the United States AA market size and potential commercial opportunities, and Q32 Bio's beliefs, expectations and assumptions regarding the future of its business, future plans and strategies, 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, the sufficiency of Q32 Bio's cash and cash equivalents to provide financial runway and that we 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

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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 bempikibart trial show at Week 36?

Bempikibart produced a 35.3% mean reduction from baseline in SALT, a scalp hair-loss score, in the modified intent-to-treat analysis. SALT-20, representing 80% scalp hair coverage, was achieved by 40.0% (10/25) in that analysis and 30.3% (10/33) in the intent-to-treat analysis.

Did responses to Q32 Bio's bempikibart persist after treatment stopped?

Response was maintained through 16 weeks off treatment in all 12 patients who entered follow-up with hair growth at Week 36, and 42% improved further. Maintenance meant less than a 20-point worsening in SALT score from the last on-treatment value.

How was bempikibart dosed in Q32 Bio's SIGNAL-AA Part B trial?

Patients received 200mg weekly for four doses, followed by 200mg every other week over 32 weeks, all by injection under the skin. The total treatment period was 36 weeks, followed by 16 weeks off treatment before optional enrollment in the open-label extension.

How did prior JAK inhibitor treatment affect Q32 Bio's bempikibart trial results?

Mean SALT reductions from baseline were 48.3% in prior JAK inhibitor responders, 4.8% in prior non-responders, and 44.1% in patients without prior JAK inhibitor treatment. The modified intent-to-treat analysis included 10 previously treated patients: four had responded to their most recent JAK inhibitor and six had not.

When does Q32 Bio expect bempikibart extension-study data?

Q32 Bio anticipates Part B open-label extension data in the second half of 2027. Enrollment and dosing remain ongoing. The off-drug follow-up and extension analyses will inform a potential long-term maintenance regimen, which could include monthly, bi-monthly or quarterly dosing evaluated in future studies.