QTTB

Q32 Bio Inc. (NASDAQ:QTTB) shares surged 60% on Monday after the biotechnology company announced positive topline results from the 36-week Part B analysis of its SIGNAL-AA Phase 2a study evaluating bempikibart for the treatment of severe and very severe alopecia areata. The encouraging clinical update strengthened investor optimism around the therapy’s development prospects and the company’s plans to advance the programme toward late-stage trials. The Phase 2a trial met its primary efficacy endpoint, with patients in the prespecified modified intent-to-treat (mITT) population recording a mean 35.3% reduction in Severity of Alopecia Tool (SALT) scores from baseline after 36 weeks. The company also reported that 40.0% of patients in the mITT population achieved a SALT-20 response by Week 36, while 30.3% of all enrolled patients in the intent-to-treat analysis reached the same milestone. The study enrolled 33 participants with severe or very severe alopecia areata, each with baseline SALT scores ranging from 50 to 100. More than one-third of the patients (36.4%) had previously received treatment with oral JAK inhibitors. Participants were initially given four weekly loading doses of 200mg of bempikibart before moving to a maintenance schedule of 200mg every other week for the remaining 32 weeks of the study. Q32 Bio said bempikibart continued to demonstrate a favourable safety profile throughout the trial. No treatment-related serious adverse events or Grade 3 or higher adverse events were reported. The most common treatment-emergent adverse event was injection-site reactions, affecting 36.3% of patients. According to the company, these reactions were generally mild and resolved without medical intervention. Following the positive Phase 2a findings, Q32 Bio intends to move bempikibart into a registration-directed clinical programme during the first half of 2027. The company also plans to present the complete Part B dataset at a future scientific conference. Bempikibart is a fully human anti-IL-7Rα antibody designed to restore adaptive immune function by blocking IL-7 and TSLP signalling pathways.

-- Clinically meaningful efficacy data on the primary endpoint was observed with a mean percent reduction in SALT score from baseline of 35.3% in the prespecified mITT analysis -- -- 40.0% of patients achieved SALT-20 response at Week 36 in the mITT analysis and 30.3% of patients achieved SALT-20 response at Week 36 in the ITT analysis of all enrolled patients -- -- Generally well-tolerated safety profile, consistent with prior studies, with no new safety signals -- -- Bempikibart demonstrated a favorable PK, PD and ADA profile -- -- Data supports further development of bempikibart in alopecia areata; Company intends to advance a registration-directed program in the first half of 2027 -- -- Q32 Bio to host conference call and webcast today, July 13, 2026, at 8:00 a.m. E.T., featuring alopecia areata key opinion leader (KOL) Arash Mostaghimi, MD, MPA, MPH -- WALTHAM, Mass., July 13, 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 positive 36-week topline results from Part B of the SIGNAL-AA Phase 2a clinical trial evaluating bempikibart in patients with severe or very severe AA. Bempikibart is a fully human anti-IL-7Rα antibody designed to re-regulate adaptive immune function by blocking IL-7 and TSLP signaling. "Today's Part B 36-week topline results mark a significant milestone for Q32 Bio, supporting our target efficacy and safety profile and providing compelling evidence reinforcing the therapeutic potential of bempikibart in alopecia areata," said Jodie Morrison, Chief Executive Officer of Q32 Bio. "We believe these findings highlight the opportunity to deliver a differentiated, targeted treatment option for patients who remain in need of an effective, safe, and more durable alternative to JAK inhibitors. These results support advancement in alopecia areata and strengthen our conviction in bempikibart's applicability across the broader autoimmune and inflammatory landscape. We are grateful to the patients, investigators, employees, and clinical development partners who helped make today's announcement possible." "Alopecia areata is a complex, immune driven disease with limited therapeutic options. The robust efficacy data in a population that includes JAK inhibitor-exper...

-- Conference call to be held Monday, July 13th at 8:00 a.m. E.T. -- WALTHAM, Mass., July 10, 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 it will report 36-week topline results from Part B of the SIGNAL-AA Phase 2a clinical trial evaluating bempikibart in patients with severe or very severe AA on Monday, July 13, 2026. Following the announcement, Q32 Bio will host a conference call and webcast at 8:00 a.m. E.T. on Monday, July 13, 2026 to discuss the results. Conference Call Q32 Bio's live conference call and webcast with accompanying slides will begin on Monday, July 13, 2026 at 8:00 a.m. E.T. To access a live or recorded webcast of the call and accompanying slides, please visit the "Investors" section of the Q32 Bio website at www.Q32Bio.com. To access the live conference call, please dial 1-800-836-8184 from the United States or 1-646-357-8785 from other locations; to access the webcast please login to https://app.webinar.net/m5ZoPmkRXdL. 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, United States Securities and Exchange Commission (the "SEC") filings, press releases, public conference call tra...

-- Bempikibart 36-week topline data readout from Part B of SIGNAL-AA Phase 2a clinical trial on-track for mid-2026 -- -- First patient dosed in SIGNAL-AA Part B open-label extension (OLE) -- -- Completed $10.5 million registered direct offering (RDO) -- -- Cash and cash equivalents of $50.8 million as of March 31, 2026, combined with guaranteed near-term milestone payments from ADX-097 asset sale and proceeds from sales under at-the-market (ATM) program received after the end of the quarter, are expected to provide financial runway into 1H'2028 -- WALTHAM, Mass., May 5, 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 March 31, 2026, and provided recent corporate updates. "In the first quarter of 2026, we made meaningful strides advancing Part B of the SIGNAL-AA Phase 2 clinical trial evaluating bempikibart in patients with AA, and we remain focused on releasing 36-week topline data by mid-year. We continue to be encouraged by the profile of bempikibart in Part B based on pharmacokinetic data and clinical activity observed to-date," said Jodie Morrison, Chief Executive Officer of Q32 Bio. "There is significant demand from patients in Part B for continued dosing after the post-treatment follow-up period, and we are thrilled to announce that the first patient has been dosed in the OLE portion of Part B. Alongside this progress, we raised gross proceeds of $10.5 million through a registered direct offering and gross proceeds of $14.2 million via our ATM program, further strengthening our financial position." First Quarter 2026 and Recent Business Highlights Part B of the SIGNAL-AA Phase 2a clinical trial remains on-track, with 36-week topline data readout expected in mid-2026. The Part B portion of the SIGNAL-AA Phase 2a clinical trial 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 with a maximum duration of current episode of four years. Total enrollment exceeded the initial target due to patient demand. Patients are treated with bempikibart for 36 weeks, with post-trea...

WALTHAM, Mass. (AP) — WALTHAM, Mass. (AP) — Q32 Bio Inc. (QTTB) on Tuesday reported a loss of $7.6 million in its first quarter. On a per-share basis, the Waltham, Massachusetts-based company said it had a loss of 54 cents. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on QTTB at https://www.zacks.com/ap/QTTB

We expect investors to focus on updates related to Q32 Bio’s QTTB pipeline development when it reports first-quarter 2026 earnings. Since the company lacks a marketed drug in its portfolio, no revenues are expected to have been recorded from product sales in the first quarter of 2026. The Zacks Consensus Estimate for the first-quarter bottom line is pegged at a loss of 52 cents per share. With no approved/marketed product in its portfolio, investor focus on Q32 Bio’s earnings call is likely to be on updates related to its most advanced product candidate, bempikibart (ADX-914), a fully human anti-IL-7Rα antibody, which is being developed for treating alopecia areata (“AA”). The company recently completed enrollment in part B of the phase IIa SIGNAL-AA study, which is evaluating bempikibart in patients with severe or very severe AA. Patients in the study will receive bempikibart for 36 weeks, with follow-up out to 52 weeks. Top-line data from the study is expected to be announced in mid-2026. Investors will be keen to get more updates on the same on the first-quarter earnings call. The FDA previously granted Fast Track designation to bempikibart for the treatment of AA. Year to date, shares of Q32 Bio have surged 65.6% against the industry’s 1.5% decline. Image Source: Zacks Investment Research In December 2025, Q32 Bio sold its phase II complement inhibitor, ADX-097, to Akebia Therapeutics AKBA. This deal with AKBA looks like a strategic fit for Q32 Bio, as it is likely to help the latter focus on advancing bempikibart for AA and fund pipeline development activities. Per the deal, Q32 Bio is eligible to receive up to a total of $592 million as potential milestone payments, including an upfront payment of $12 million from Akebia. This is likely to fund QTTB’s operations into the fourth quarter of 2027. Operating expenses are likely to have declined in the to-be-reported quarter, reflecting lower costs related to clinical studies and other expenses. Q32 Bio has an encouraging history of earnings surprises. The company beat on earnings in each of the trailing three quarters, delivering an average surprise of 205.94%. In the last reported quarter, QTTB delivered an earnings surprise of 529.41%. Q32 Bio Inc. price-eps-surprise | Q32 Bio Inc. Quote Our proven model does not conclusively predict an earnings beat for Q32 Bio this time around. The combination of a pos...

WALTHAM, Mass. (AP) — WALTHAM, Mass. (AP) — Q32 Bio Inc. (QTTB) on Tuesday reported net income of $57.7 million in its fourth quarter. On a per-share basis, the Waltham, Massachusetts-based company said it had net income of $4.58. Earnings, adjusted for non-recurring gains, came to $3.65 per share. The gene editing company posted revenue of $53.7 million in the period. For the year, the company reported profit of $29.8 million, or $2.42 per share. Revenue was reported as $53.7 million. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on QTTB at https://www.zacks.com/ap/QTTB

-- Completed enrollment in Part B of SIGNAL-AA Phase 2a clinical trial and increased trial size to 33 patients based on patient demand; 36-week topline data readout expected in mid-2026 -- -- Completed $10.5 million registered direct offering (RDO) -- -- Completed asset sale of Phase 2 complement inhibitor, ADX-097, to Akebia Therapeutics to further enable Company's strategic focus on advancing bempikibart for alopecia areata (AA) -- -- Cash and cash equivalents of $48.3 million as of December 31, 2025, combined with gross proceeds from RDO and guaranteed near-term milestone payments from ADX-097 asset sale, expected to provide financial runway into Q4'27 -- WALTHAM, Mass., March 10, 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 December 31, 2025, and provided recent corporate updates. "In 2025, we executed on our plan to focus on the advancement of bempikibart for the treatment of AA and as we enter 2026, we are poised to deliver 36-week topline results from Part B of SIGNAL-AA by mid-year. We are encouraged by promising pharmacokinetic data and emerging signs of clinical activity," said Jodie Morrison, Chief Executive Officer of Q32 Bio. "With a strategic focus on the advancement of bempikibart for AA, we completed the asset sale of ADX-097 to Akebia in December 2025 and completed a $10.5 million registered direct offering in February 2026. There remains significant need for safer and more durable therapies in AA, and we believe bempikibart has the potential to transform the treatment paradigm. We look forward to building on the momentum established from our clinical execution throughout 2026." Fourth Quarter 2025 and Recent Business Highlights Completed enrollment in Part B of the SIGNAL-AA Phase 2a clinical trial and increased the trial size to 33 patients based on patient demand, with 36-week topline data readout expected in mid-2026. The Part B portion of the SIGNAL-AA Phase 2a clinical trial 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 with a maximum durat...

WALTHAM, Mass. (AP) — WALTHAM, Mass. (AP) — Q32 Bio Inc. (QTTB) on Thursday reported a loss of $7.4 million in its third quarter. The Waltham, Massachusetts-based company said it had a loss of 60 cents per share. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on QTTB at https://www.zacks.com/ap/QTTB

-- 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 Completed enrollment in Part B of the SIGNAL-AA Phase 2a clinical trial and increased the trial size to 33 patients based on patient demand, with topline data readout expected in mid-2026. The Part B portion of the SIGNAL-AA Phase 2a clinical trial 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 with a maximum duration of current episode of four years. Patients will be treated with bempikibart for 36 weeks, with follow-up out to 52 weeks. Dosing includes an ini...

-- Dosing of patients in Part A open-label extension (OLE) and Part B of SIGNAL-AA ongoing; SIGNAL-AA Part B topline data readout on-track for 1H'26 -- -- Strengthened leadership team with appointment of Adrien Sipos, M.D., Ph.D., an immunologist and seasoned Immunology and Inflammation (I&I) drug developer, as Interim Chief Medical Officer -- -- Cash and cash equivalents of $54.8 million as of June 30, 2025, which is now expected to provide financial runway into 2027 -- WALTHAM, Mass., Aug. 6, 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 June 30, 2025, and provided recent corporate updates. "This quarter, we continued to execute across our bempikibart development program with patient dosing underway and enrollment on-track in both the Part A OLE and Part B portions of the Phase 2a SIGNAL-AA trial," said Jodie Morrison, Chief Executive Officer of Q32 Bio. "We strengthened our leadership team with the addition of Adrien Sipos, M.D., Ph.D., as Interim Chief Medical Officer, whose immunology and inflammation drug development expertise will be invaluable as we advance bempikibart through key stages of development. We remain ever-focused on advancing bempikibart for patients with alopecia areata and are on track to deliver topline data from Part B in the first half of next year while extending our cash runway into 2027." Second Quarter 2025 and Recent Business Highlights Dosing of patients in Part B of the SIGNAL-AA Phase 2a clinical trial is ongoing, with topline data readout on-track for the first half of 2026. Part B of the SIGNAL-AA Phase 2a clinical trial 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 patients with severe or very severe AA. The ongoing trial will dose approximately 20 evaluable patients with severe or very severe AA with bempikibart for 36 weeks, with follow-up out to 52 weeks. Dosing includes an initial loading regimen of 200mg of bempikibart dosed weekly over four weeks, followed by a maintenance dose of 200mg every-other-week over a 32-week period for a total dosing period of 36 weeks....

WALTHAM, Mass. (AP) — WALTHAM, Mass. (AP) — Q32 Bio Inc. (QTTB) on Wednesday reported a loss of $9.5 million in its second quarter. On a per-share basis, the Waltham, Massachusetts-based company said it had a loss of 78 cents. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on QTTB at https://www.zacks.com/ap/QTTB