QTTB

-- Reported positive bempikibart 36-week topline results from Part B of SIGNAL-AA clinical trial; additional details from 36-week results and initial findings from 52-week results to be presented at a medical conference in the second half of 2026 -- -- Patient enrollment and dosing in SIGNAL-AA Part B open-label extension (OLE) ongoing -- -- Registration-directed program evaluating bempikibart in patients with severe or very severe AA expected to initiate in 1H'2027 subject to planned regulatory discussions later this year -- -- Half-life extended fully human anti-IL-7Rα antibody, ADX-914-XL, advancing in pre-clinical development -- -- Completed $200 million public offering in July 2026 -- -- Cash and cash equivalents of $106.3 million as of June 30, 2026, combined with proceeds from July 2026 public offering, are expected to provide financial runway through Phase 3 topline results from planned registration-directed program -- WALTHAM, Mass., Aug. 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 June 30, 2026, and provided recent corporate updates. "Our progress so far this year has been transformative for Q32 Bio and our bempikibart development program. In July, we reported positive topline results from Part B of our SIGNAL-AA program, demonstrating clinically meaningful efficacy, preliminary signs of durability, and a well-tolerated safety profile in patients with severe and very severe alopecia areata. We look forward to sharing additional details from our 36-week results and initial findings from our 52-week results at an upcoming medical meeting," said Jodie Morrison, Chief Executive Officer of Q32 Bio. "The emerging profile of bempikibart represents a compelling opportunity to address the shortcomings of currently available treatments for patients in need of an effective, safe, and more durable alternative. We believe our data has set the bar for a biologic in alopecia areata and demonstrates the potential for bempikibart to become a standard of care, first-line option for patients." Ms. Morrison added, "With our recently completed public offering and 36-week Part B results, we are well positioned to advance planned regulatory discussions and initiate a registration-directed program evaluating bempikibart in severe and very severe alopecia areata in the first half of 2027. Additionally, we believe the results observed across bempikibart development to date represent a foundation for broader development, and we are currently evaluating opportunities in expanded alopecia areata populations, as well as in additional I&I indications where IL-7 and TSLP signaling play a role. In parallel, we are advancing a half-life extended development candidate with the same mechanism of action as bempikibart." Second Quarter 2026 and Recent Business Highlights Reported positive 36-week topline results from Part B of the SIGNAL-AA Phase 2a clinical trial. 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 are treated with bempikibart for 36 weeks, with off-drug follow-up out to 52 weeks before optional enrollment in the open-label extension ("OLE"). In Part B, bempikibart demonstrated clinically meaningful efficacy 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 Part B, bempikibart was generally well-tolerated, consistent with prior studies, with no new safety signals, and demonstrated a favorable pharmacokinetic, pharmacodynamic and anti-drug antibody profile. Results from SIGNAL-AA Part B, including additional Week 36 data as well as initial findings from the off-drug period through Week 52, will be presented at a medical meeting in the second half of 2026. Patient enrollment and dosing in the SIGNAL-AA Part B OLE remain ongoing. Following completion of the Part B 36-week treatment period and 16-week off-drug follow-up period through Week 52, 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. 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 in patients with severe or very severe AA into a registration-directed program 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 additional immunology and inflammation ("I&I") indications. Half-life extended fully human anti-IL-7Rα antibody, ADX-914-XL, advancing in pre-clinical development. Today, Q32 Bio announced that ADX-914-XL, a fully human half-life extended anti-IL-7Rα antibody designed to re-regulate adaptive immune function by blocking IL-7 and TSLP signaling, is advancing in pre-clinical 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 $106.3 million as of June 30, 2026, which excludes proceeds from our July 2026 public offering. Q32 Bio believes its cash and cash equivalents as of June 30, 2026, combined with proceeds from the July 2026 public offering, 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 $4.3 million for the three months ended June 30, 2026, compared to $5.2 million for the three months ended June 30, 2025. The decrease was due to lower ADX-097 spend due to the sale of the program in November 2025, partially offset by higher bempikibart manufacturing costs and nonclinical activities as compared to the prior year. General and administrative expenses were $4.9 million for the three months ended June 30, 2026, compared to $4.0 million for the three months ended June 30, 2025. The increase was primarily due to higher stock-based compensation expense and other expenses as compared to the prior year. Net loss was $8.9 million, or $0.44 basic and diluted net loss per share, for the three months ended June 30, 2026, compared to net loss of $9.5 million, or $0.78 basic and diluted net loss per share, for the three months ended June 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 are forward-looking statements, including, among others, Q32 Bio's beliefs, observations, expectations and assumptions regarding the topline data from Part B of the SIGNAL-AA Phase 2a clinical trial and the anticipated timing of its data, the safety, tolerability, clinical activity including biomarker data, potential efficacy and potential benefits of bempikibart including plans and expectations for Part B of the SIGNAL-AA Phase 2a clinical trial, Q32 Bio's expectations and assumptions regarding the timing of reporting the findings from the Part B OLE of the SIGNAL-AA Phase 2a clinical trial, 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 pre-clinical development regarding ADX-914-XL 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 topline Phase 3 results from its planned registration-directed program evaluating bempikibart in patients with severe or very severe AA; 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 might be more costly than expected or might not yield anticipated results, that Q32 Bio may use its capital resources sooner than currently anticipated, our expectations regarding the sufficiency of our 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 Annual Report on Form 10-K for the year ended December 31, 2025 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 BurnsArgot [email protected] Media: David RosenArgot [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/q32-bio-reports-second-quarter-2026-financial-results-and-provides-corporate-update-302843061.html

-- 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-experienced patients, combined with a differentiated safety profile, demonstrate the potential for bempikibart to be a first-line treatment for alopecia areata," said Arash Mostaghimi, MD, MPA, MPH, Associate Professor of Dermatology and Vice Chair of Clinical Trials and Innovation, Brigham and Women's Hospital, Harvard Medical School. "For patients and prescribers seeking an effective and safe alternative to JAK inhibitors, these findings are encouraging and merit further clinical advancement." 36-Week Topline 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 therapy were allowed; amongst the 33 enrolled patients, 36.4% had previously been treated with oral JAK inhibitors. Total enrollment exceeded the initial target due to patient demand. In Part B, patients are treated with bempikibart for 36 weeks, with 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, with follow-up through Week 52. Key topline efficacy results from Part B of SIGNAL-AA at Week 36 include: 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. Achievement of a SALT-20 response was observed in patients with both severe and very severe disease. 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. Early signs of durability in the off-drug period include maintenance or deepening of response in multiple patients including one who achieved complete hair growth (SALT = 0). 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 (SAEs) 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. Bempikibart demonstrated a favorable pharmacokinetic (PK), pharmacodynamic and anti-drug antibody (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. Negligible ADA was observed in Part B. "These results provide important further evidence that our differentiated approach to targeting the biology underlying alopecia areata has the potential to translate into meaningful and durable clinical benefit for patients," said Shelia Violette, Ph.D., Co-Founder and Chief Scientific Officer of Q32 Bio. "Despite recent advances, many patients continue to seek treatment options that combine robust efficacy with improved safety and the potential for sustained disease control. These findings strengthen our confidence in the therapeutic potential of this mechanism and its continued advancement as a differentiated treatment option for patients living with alopecia areata and other autoimmune and inflammatory diseases." The Part B off-drug follow-up period through Week 52 remains ongoing. Additionally, enrollment of eligible patients into the OLE remains ongoing. Q32 Bio intends to advance bempikibart into a registration-directed program in the first half of 2027 and plans to share full results from Part B at a future medical meeting. Results from SIGNAL-AA Part A OLE: Following the emergence of Part A data suggesting durability of response in the off-drug follow-up from SIGNAL-AA Part A and given patient demand for continued dosing, Q32 Bio announced the initiation of an OLE in April 2025. The Part A OLE has been completed. Eight patients enrolled in the Part A OLE, spanning responders, non-responders, and placebo patients from the Part A treatment portion. Patients were off-drug for various time periods ranging from 26 to 55 weeks prior to re-dosing. In the Part A OLE, bempikibart continued to demonstrate a generally well-tolerated safety profile with longer-term dosing and no new safety issues. Patients who maintained hair at entry to the OLE were observed to have durable or further hair growth. In totality, the Part A OLE dataset supports the importance of a maintenance dosing regimen. Conference Call In connection with this announcement, Q32 Bio will host a conference call and webcast with accompanying slides today at 8:00 a.m. E.T. This event will feature Arash Mostaghimi, MD, MPA, MPH, Associate Professor of Dermatology and Vice Chair of Clinical Trials and Innovation, Brigham and Women's Hospital, Harvard Medical School. 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, 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. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. Certain information in this press release constitutes forward-looking statements and forward-looking information (collectively, ‎‎"forward-looking information") within the meaning of applicable securities laws. In some cases, but not necessarily in all cases, forward-looking information can be identified by the ‎use of forward-looking terminology such as "plans", "excited to", "targets", "expects" or "does not expect", "is expected", "an opportunity exists", ‎‎"is positioned", "estimates", "intends", "assumes", "anticipates" or "does not anticipate" or "believes", or variations of such words and ‎phrases or state that certain actions, events or results "may", "could", "would", "might", "will" or "will be taken", "occur" or "be ‎achieved". In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances contain forward-looking information. Specifically, this press release contains forward-looking information relating to the beliefs, observations, expectations and assumptions regarding the topline data from Part B of the SIGNAL-AA Phase 2a clinical trial and 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 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, among others. Statements containing forward-looking information are not historical facts but instead represent management's current expectations, estimates and projections regarding the future of our business, future plans, strategies, projections, anticipated events and trends, the economy and other future conditions. Forward-looking information is necessarily based on a number of opinions, assumptions and estimates that, while considered reasonable by Q32 Bio as of the date of this press release, are subject to known and unknown risks, uncertainties and assumptions and other factors that may cause the actual results, level of activity, performance or achievements to be materially different from those expressed or implied by such forward-looking information. Such risks and uncertainties include, but are not limited to, 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, 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 the "Risk Factors" section of Q32 Bio's most recently Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the SEC, and subsequent quarterly reports. Except as required by applicable securities laws, Q32 Bio undertakes no obligation to publicly update any forward-looking information, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. Contacts:Investors: Brendan BurnsArgot [email protected] Media: David RosenArgot [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/q32-bio-announces-positive-36-week-topline-results-from-part-b-of-the-signal-aa-clinical-trial-of-bempikibart-in-alopecia-areata-302823403.html

-- 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 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. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. Certain information in this press release constitutes forward-looking statements and forward-looking information (collectively, ‎‎"forward-looking information") within the meaning of applicable securities laws. In some cases, but not necessarily in all cases, forward-looking information can be identified by the ‎use of forward-looking terminology such as "plans", "excited to", "targets", "expects" or "does not expect", "is expected", "an opportunity exists", ‎‎"is positioned", "estimates", "intends", "assumes", "anticipates" or "does not anticipate" or "believes", or variations of such words and ‎phrases or state that certain actions, events or results "may", "could", "would", "might", "will" or "will be taken", "occur" or "be ‎achieved". In addition, any statements that refer to expectations, projections or other characterizations of future events or ‎circumstances contain forward-looking information. Specifically, this press release contains forward-looking information relating to the expected timing for the announcement of and conference call discussing 36-week topline data from Part B of the SIGNAL-AA Phase 2a clinical trial of bempikibart in AA. Statements containing forward-looking information are not historical facts but instead represent management's current ‎expectations, estimates and projections regarding the future of our business, future plans, strategies, projections, anticipated events ‎and trends, the economy and other future conditions. Forward-looking information is necessarily based on a number of opinions, assumptions and estimates that, while considered reasonable by Q32 Bio as of the date of this press release, are subject to ‎known and unknown risks, uncertainties and assumptions and other factors that may cause the actual results, level of activity, ‎performance or achievements to be materially different from those expressed or implied by such forward-looking information. Such risks and uncertainties include, but not limited to, 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, 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 the "Risk Factors" section of Q32 Bio's most recently Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the Securities and Exchange Commission, and subsequent quarterly reports. Except as required by applicable securities laws, Q32 Bio undertakes no obligation to publicly update any forward-looking information, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. Contacts:Investors: Brendan BurnsArgot [email protected] Media: David RosenArgot [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/q32-bio-to-report-36-week-topline-results-from-part-b-of-signal-aa-clinical-trial-of-bempikibart-in-alopecia-areata-on-july-13-2026-302822915.html

-- 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-treatment follow-up out to 52 weeks before optional enrollment in the OLE. Dosing includes an initial loading regimen of 200mg of bempikibart dosed weekly for four doses, followed by a maintenance dose of 200mg every-other-week over a 32-week period, for a total dosing period of 36 weeks. Efficacy will be evaluated on the basis of mean percentage change from baseline in Severity of Alopecia Tool (SALT) scores, as well as the proportion of subjects achieving various relative and absolute SALT improvements at week 36, with follow-up through week 52. Encouraging signs of clinical activity are being observed in Part B of the trial. In addition, based on preliminary pharmacokinetic data available to date in the Part B portion of SIGNAL-AA, steady state concentration of drug in patients was observed at least nine weeks earlier as compared to Part A of the clinical trial due to the inclusion of the loading regimen, which may have the potential to induce earlier responsiveness. The trial is intended to support advancement into pivotal trials upon completion, pending review of the results. Q32 Bio expects to report 36-week topline results in mid-2026. After completion of the trial through 52 weeks, eligible patients can enter an open-label extension (OLE) period following the same dosing paradigm as Part B, to enable longer-term follow-up and continued data collection. The first patient has been dosed in the OLE portion of Part B. Part A OLE of the SIGNAL-AA Phase 2a clinical trial is complete. Based on the continued emergence of bempikibart data suggesting a remittive effect and durable responses in long-term follow-up from SIGNAL-AA Part A, as well as strong re-consent rates and patient demand for continued dosing, Q32 Bio initiated an OLE in April 2025 for eligible patients that completed Part A to enable longer-term follow-up of patients. The Part A OLE has been completed, and Q32 Bio intends to report findings from the Part A OLE with the Part B 36-week topline results in mid-2026. Completed $10.5 million registered direct offering . In February 2026, Q32 Bio completed a registered direct offering of 1,666,679 shares of common stock and pre-funded warrants to purchase up to 1,025,654 shares of common stock at an offering price of $3.90 per share of common stock and $3.8999 per pre-funded warrant. The gross proceeds to Q32 Bio from this offering were approximately $10.5 million, before deducting certain offering expenses of approximately $0.1 million. This transaction was led by a new institutional investor with participation by an existing dedicated public institutional investor. Financial Results Cash and cash equivalents were $50.8 million as of March 31, 2026, which excludes $14.2 million in gross proceeds from sales under our at-the-market (ATM) program received after the end of the quarter. Q32 Bio believes its cash and cash equivalents as of March 31, 2026, combined with guaranteed near-term milestone payments from the ADX-097 asset sale and proceeds from sales under the ATM program after the end of the quarter, are sufficient to fund operations into the first half of 2028. Research and development expenses were $3.2 million for the three months ended March 31, 2026, compared to $7.1 million for the three months ended March 31, 2025. The decrease was due to lower personnel-related costs due to reduced headcount, lower bempikibart clinical expense, as well as lower ADX-097 spend due to the sale of the program in November 2025, as compared to the prior year. General and administrative expenses were $4.5 million for the three months ended March 31, 2026, compared to $5.1 million for the three months ended March 31, 2025. The decrease was primarily due to lower legal and consulting costs as compared to the prior year. Net loss was $7.6 million, or $0.54 basic and diluted net loss per share, for the three months ended March 31, 2026, compared to net loss of $11.0 million, or $0.90 basic and diluted net loss per share, for the three months ended March 31, 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 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 expectations based on the signs observed to date in Part B of the SIGNAL-AA Phase 2a clinical trial, Q32 Bio's expectations and assumptions regarding the timing of reporting the findings from the Part A OLE of the SIGNAL-AA Phase 2a clinical trial, 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 the first half of 2028; 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, our expectations regarding the sufficiency of our 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 Annual Report on Form 10-K for the year ended December 31, 2025 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 Argot Partners 212.600.1902 [email protected] Media: David Rosen Argot Partners 646.461.6387 [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/q32-bio-reports-first-quarter-2026-financial-results-and-provides-corporate-update-302762570.html

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 positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) increases the odds of an earnings beat. That is not the case here, as you will see below. You can uncover the best stocks to buy or sell before they're reported with our Earnings ESP Filter. Earnings ESP: Q32 Bio has an Earnings ESP of 0.00%. Zacks Rank: QTTB currently sports a Zacks Rank #1 at present. You can see the complete list of today’s Zacks #1 Rank stocks here. Here are some stocks worth considering from the healthcare space, as our model shows that these have the right combination of elements to beat on earnings this reporting cycle. Agenus AGEN has an Earnings ESP of +7.69% and a Zacks Rank #1 at present. Shares of AGEN have risen 22.3% year to date. The company’s earnings beat estimates in two of the trailing four quarters, while missing the mark on the other two occasions. Agenus delivered an average earnings surprise of 31.42%. Inovio Pharmaceuticals INO has an Earnings ESP of +3.33% and a Zacks Rank #2 at present. Shares of INO have lost 35.7% year to date. The company’s earnings beat estimates in each of the trailing four quarters. INO delivered an average earnings surprise of 57.94%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Agenus Inc. (AGEN) : Free Stock Analysis Report Inovio Pharmaceuticals, Inc. (INO) : Free Stock Analysis Report Akebia Therapeutics, Inc. (AKBA) : Free Stock Analysis Report Q32 Bio Inc. (QTTB) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

-- 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 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 initial loading regimen of 200mg of bempikibart dosed weekly for four doses, followed by a maintenance dose of 200mg every-other-week over a 32-week period for a total dosing period of 36 weeks. Efficacy will be evaluated on the basis of mean percentage change from baseline in Severity of Alopecia Tool (SALT) scores as well as the proportion of subjects achieving various relative and absolute SALT improvements at week 36, with follow-up through week 52. Emerging signs of clinical activity are being observed in Part B of the trial. In addition, based on preliminary pharmacokinetic data available to date in the Part B portion of SIGNAL-AA, steady state concentration of drug in patients is achieved at least nine weeks earlier as compared to Part A of the clinical trial due to the inclusion of the loading regimen, which may have the potential to induce earlier responsiveness. The trial is intended to support advancement into pivotal trials upon completion, pending review of the results. Q32 Bio expects to report 36-week topline results in mid-2026. Part A OLE of the SIGNAL-AA Phase 2a clinical trial is ongoing. Based on the continued emergence of bempikibart data suggesting a remittive effect and durable responses in long-term follow-up from SIGNAL-AA Part A, as well as re-consent rates and strong patient demand for continued dosing, Q32 Bio initiated an OLE in April 2025 for eligible patients that completed Part A to enable longer-term follow-up of patients and remains ongoing. Completed $10.5 million registered direct offering ("RDO"). In February 2026, Q32 Bio completed an RDO of 1,666,679 shares of common stock and pre-funded warrants to purchase up to 1,025,654 shares of common stock at an offering price of $3.90 per share of common stock and $3.8999 per pre-funded warrant. The gross proceeds to Q32 Bio from this offering were approximately $10.5 million, before deducting certain offering expenses. Sold Phase 2 complement inhibitor, ADX-097, to Akebia Therapeutics ("Akebia"). Akebia has acquired ADX-097 and will be responsible for its future development and commercialization. Under the terms of the agreement, Q32 Bio will receive $12 million in upfront payments and a near-term milestone, which includes $7 million received at signing during the fourth quarter of 2025, $3 million at the 6-month anniversary of signing, and $2 million payable upon the earlier of the achievement of a milestone or the end of 2026. Including these payments, Q32 Bio is eligible to receive up to $592 million upon the achievement of certain development, regulatory and commercial milestones. Q32 Bio is also eligible to receive tiered royalties on potential future sales of ADX-097, ranging from low single-digit to mid-teen percentages. Terminated all remaining obligations to Amgen (formerly Horizon). Q32 Bio entered into an amendment to the Termination Agreement with Amgen pursuant to which Q32 Bio made a one-time equity grant to Amgen as full consideration of potential milestone payments owed under such agreement. Q32 Bio now has no remaining obligations to Amgen. Financial Results Cash and cash equivalents were $48.3 million as of December 31, 2025, which excludes proceeds from the February 2026 RDO received after the end of the quarter. Q32 Bio believes its cash and cash equivalents, combined with gross proceeds from the RDO and guaranteed near-term milestone payments from the ADX-097 asset sale, will be sufficient to fund operations into the fourth quarter of 2027, through 36-week topline results of the SIGNAL-AA Part B trial evaluating bempikibart in patients with AA which are expected in mid-2026. Research and development expenses were $3.3 million and $19.2 million for the quarter and full year ended December 31, 2025, respectively, compared to $10.5 million and $48.1 million for the quarter and full year ended December 31, 2024, respectively. The decrease in both periods was primarily due to lower bempikibart development costs including clinical and manufacturing expenses, lower ADX-097 program spend due to the discontinuation of the ADX-097 Phase 2 renal basket clinical trial, as well as lower personnel-related costs as compared to the prior year. General and administrative expenses were $4.5 million and $17.7 million for the quarter and full year ended December 31, 2025, respectively, compared to $4.0 million and $18.0 million for the quarter and full year ended December 31, 2024, respectively. The increase in expense for the quarter ended December 31, 2025 as compared to the prior year was primarily due to higher personnel-related costs, including stock-based compensation. The decrease in expense for the full year 2025 as compared to 2024 was primarily due to lower personnel-related costs. Net income was $57.7 million, or $4.60 basic and $4.58 diluted net income per share, and $29.8 million, or $2.42 basic and diluted net income per share, for the quarter and full year ended December 31, 2025, respectively, compared to net loss of ($14.2) million, or ($1.16) basic and diluted net loss per share, and ($47.7) million, or ($5.12) basic and ($6.58) diluted net loss per share for the quarter and full year ended December 31, 2024, respectively. Net income for the quarter and full year ended December 31, 2025 is primarily driven by the recognition of non-cash collaboration revenue associated with entering into the amended agreement with Amgen as well as the sale of ADX-097 to Akebia in the fourth quarter of 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 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, Q32 Bio's beliefs, observations, expectations and assumptions regarding the sale of ADX-097 and potential for future milestone payments and royalties, the intended use of proceeds from the registered direct offering, 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 the fourth quarter of 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, our expectations regarding the sufficiency of our 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 September 30, 2025 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 Argot Partners 212.600.1902 [email protected] Media: David Rosen Argot Partners 646.461.6387 [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/q32-bio-reports-fourth-quarter-2025-financial-results-and-provides-corporate-update-302708710.html

-- 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 initial loading regimen of 200mg of bempikibart dosed weekly for four doses, followed by a maintenance dose of 200mg every-other-week over a 32-week period for a total dosing period of 36 weeks. Efficacy will be evaluated on the basis of mean percentage change from baseline in Severity of Alopecia Tool (SALT) scores as well as the proportion of subjects achieving various relative and absolute SALT improvements at week 36, with follow-up through week 52. Emerging signs of clinical activity are being observed amongst the early-enrolling patients in Part B of the trial. In addition, based on preliminary pharmacokinetic data available to date in the Part B portion of SIGNAL-AA, steady state concentration of drug in patients is achieved at least nine weeks earlier as compared to Part A of the clinical trial due to the inclusion of the loading regimen, which may have the potential to induce earlier responsiveness. The trial is intended to support advancement into pivotal trials upon completion, pending review of the results. Q32 Bio expects to report topline results in mid-2026. Dosing of patients in Part A OLE of the SIGNAL-AA Phase 2a clinical trial is ongoing. Based on the continued emergence of bempikibart data suggesting a remittive effect and durable responses in long-term follow-up from SIGNAL-AA Part A, as well as re-consent rates and strong patient demand for continued dosing, Q32 Bio initiated an OLE in April 2025 for eligible patients that completed Part A to enable longer-term follow-up of patients. Patient dosing is ongoing. Financial Results Cash and cash equivalents were $49.0 million as of September 30, 2025. Q32 Bio believes its cash and cash equivalents are sufficient to fund operations into 2027, through topline results of the SIGNAL-AA Part B trial evaluating bempikibart in patients with AA expected in mid-2026. Research and development expenses were $3.6 million for the three months ended September 30, 2025, compared to $14.3 million for the three months ended September 30, 2024. The decrease in expense of $10.7 million was primarily due to lower bempikibart development costs including clinical and manufacturing spend, lower ADX-097 program expenses due to the discontinuation of the ADX-097 Phase 2 clinical trial, as well as lower personnel-related costs as compared to the prior year. General and administrative expenses were $4.0 million for the three months ended September 30, 2025, compared to $4.5 million for the three months ended September 30, 2024. The decrease in expense of $0.5 million was primarily due to decreased personnel-related costs as well as lower legal and other professional services costs as compared to the prior year. Net loss was $7.4 million, or $0.60 basic and diluted net loss per share, for the three months ended September 30, 2025, compared to net loss of $17.6 million, or $1.46 basic and diluted net loss per share, for the three months ended September 30, 2024. 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 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 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 Argot Partners 212.600.1902 [email protected] Media: David Rosen Argot Partners 646.461.6387 [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/q32-bio-reports-third-quarter-2025-financial-results-and-provides-corporate-update-302613664.html