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Q32 Bio Inc. (NASDAQ: QTTB) is a clinical-stage biotechnology company dedicated to developing novel biologics aimed at restoring healthy immune balance in patients with autoimmune and inflammatory diseases caused by pathological immune dysfunction. The company focuses on creating antibody-based therapeutic candidates that target two primary pathways of adaptive and innate immunity.
The adaptive immune system, which includes T- and B-cell mediated cellular and antibody responses, and the innate immune system, the body's first line of defense consisting of leukocytes, are Q32 Bio's areas of expertise. Their lead product candidate, ADX-097, is a humanized anti-C3d monoclonal antibody fusion protein from their complement inhibitor platform.
Q32 Bio has made significant strides recently. In the first quarter of 2024, the company went public and made considerable progress in their pipeline programs. Bempikibart (ADX-914), their adaptive immunity program, is currently in Phase 2 trials for treating atopic dermatitis and alopecia areata, with topline data anticipated in the fourth quarter of 2024. Meanwhile, ADX-097 is on track to begin a renal basket clinical trial in the first half of this year and aims to start a Phase 2 clinical trial for AAV next year, with topline results expected in the second half of 2025.
Q32 Bio's financial foundation has been bolstered following a successful merger and concurrent financing, positioning them strongly as a newly public company. They are backed by a robust team, recent additions to their management and board of directors, and a strong financial foundation.
The company is committed to advancing biological therapeutics targeting key regulators of the immune system to help patients manage autoimmune and inflammatory diseases. Their innovative approaches in complement system regulation and IL-7/TSLP receptor pathways aim to address immune dysregulation and provide patients with more effective treatment options.
For more detailed information and updates, visit www.Q32Bio.com.
Q32 Bio (QTTB) announced that results from Part A of its SIGNAL-AA Phase 2a clinical trial of bempikibart in patients with alopecia areata (AA) will be presented at the 2025 American Academy of Dermatology Annual Meeting in Orlando.
The presentation will highlight findings from the randomized, placebo-controlled 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 severe and very severe alopecia areata patients.
The late-breaking oral presentation will be delivered by Dr. Brett King of Dermatology Physicians of Connecticut on March 8, 2025. The company views the selection for late-breaking presentation status as recognition of bempikibart's promising clinical activity and well-tolerated safety profile.
Q32 Bio (Nasdaq: QTTB), a clinical stage biotechnology company specializing in immune homeostasis therapeutics, has announced its participation in two major investor conferences this March.
The company will present at the TD Cowen 45th Annual Health Care Conference in Boston on March 5, 2025, at 11:50 a.m. ET, followed by the Leerink Partners Global Healthcare Conference in Miami Beach on March 11, 2025, at 11:20 a.m. ET.
Webcasts of both presentations will be accessible through Q32 Bio's website, with replays available for 90 days after the events.
Q32 Bio (NASDAQ: QTTB) announced a strategic restructuring to focus on advancing bempikibart for alopecia areata (AA) treatment. The company is discontinuing its Phase 2 renal basket trial of ADX-097 and evaluating strategic options for its complement inhibitor platform. The restructuring, including personnel reductions, is expected to extend cash runway to 2H'26.
Based on encouraging results from SIGNAL-AA Part A trial, showing improvement in SALT scores and continued response through week 55, Q32 Bio plans to initiate an open-label extension in 1H'25. The company will also begin SIGNAL-AA Part B dosing in 1H'25, with topline data expected in 1H'26. Part B will evaluate approximately 20 patients with severe AA over 36 weeks of treatment.
Q32 Bio (Nasdaq: QTTB) has announced its participation in the Oppenheimer 35th Annual Healthcare Life Sciences Conference. The clinical stage biotechnology company, which specializes in developing biologic therapeutics for immune homeostasis restoration, will deliver a virtual company presentation on Tuesday, February 11, 2025, at 4:00 p.m. E.T.
Interested parties can access the presentation webcast through Q32 Bio's website at www.q32bio.com on the Events and Presentations page. The presentation recording will remain available for 90 days after the event.
Q32 Bio announced topline results from two Phase 2a clinical trials for bempikibart. The SIGNAL-AA trial in alopecia areata showed encouraging results, with patients experiencing a 16% mean reduction in SALT score versus 2% for placebo at week 24. Additionally, 13% of bempikibart patients achieved SALT-20 by week 26 compared to 0% for placebo.
However, the SIGNAL-AD trial in atopic dermatitis did not meet its primary endpoint in Part B, despite promising findings in Part A. The drug demonstrated safety and tolerability across both trials, with significant biomarker evidence showing potent IL-7 and TSLP inhibition. Based on these results, Q32 Bio plans to advance bempikibart specifically for alopecia areata treatment, expanding the SIGNAL-AA trial with approximately 20 additional patients.
Q32 Bio (NASDAQ: QTTB) reported Q3 2024 financial results with $89.1 million in cash and cash equivalents as of September 30, 2024, expected to fund operations into mid-2026. The company anticipates topline results from two Phase 2 trials of bempikibart in atopic dermatitis and alopecia areata in December 2024. Q3 saw a net loss of $17.6 million, with R&D expenses increasing to $14.3 million from $7.5 million year-over-year. Enrollment continues in the ADX-097 Phase 2 basket trial for complement mediated renal diseases, with initial data expected in 1H'25 and topline results in 2H'25.
Q32 Bio (Nasdaq: QTTB), a clinical stage biotechnology company developing biologic therapeutics for immune homeostasis, has announced its upcoming participation in Guggenheim's Inaugural Healthcare Innovation Conference. The company's management will engage in a fireside chat on Tuesday, November 12, 2024, at 10:00 a.m. E.T. in Boston, MA. The presentation will be accessible via webcast on Q32 Bio's website, with replays available for 90 days after the event.
Q32 Bio Inc. (Nasdaq: QTTB) announced it will present clinical data for ADX-097, its lead product candidate from its tissue-targeted complement inhibitor platform, at the American Society of Nephrology (ASN) Kidney Week 2024. The presentation will highlight data from the completed first-in-human, Phase 1 ascending dose clinical trial of ADX-097 in healthy volunteers.
Key points:
- ADX-097 is a humanized anti-C3d mAb fusion protein being evaluated for renal diseases associated with increased complement activation.
- The Phase 1 trial showed ADX-097 to be generally well-tolerated with desirable pharmacokinetics and pharmacodynamics properties.
- Results support Phase 2 dose selection and continued clinical advancement of ADX-097.
- Q32 Bio aims to achieve relevant complement inhibition directly in the tissue while minimizing systemic activity.
- The company is currently advancing ADX-097 in two Phase 2 clinical trials.
Q32 Bio Inc. (Nasdaq: QTTB), a clinical stage biotechnology company, has announced its participation in three upcoming investor conferences in September 2024. The company, which focuses on developing biologic therapeutics to restore immune homeostasis, will be present at:
1. Morgan Stanley 22nd Annual Global Healthcare Conference on September 5 in New York, NY
2. 2024 Cantor Fitzgerald Global Healthcare Conference on September 17 in New York, NY (presentation at 3:40 p.m. E.T.)
3. Stifel 2024 Virtual Immunology and Inflammation Summit on September 18 (virtual presentation at 11:30 a.m. E.T.)
Webcasts of the Cantor and Stifel presentations will be available on Q32 Bio's website, with archived replays accessible for 30 days after the events.
Q32 Bio (Nasdaq: QTTB) reported Q2 2024 financial results and provided corporate updates. Key highlights include:
1. Completed enrollment in bempikibart atopic dermatitis Phase 2 trial, increasing trial size to 121 patients.
2. Bempikibart Phase 2 topline results in atopic dermatitis and alopecia areata expected in Q4 2024.
3. Enrolling patients in ADX-097 Phase 2 basket trial for complement mediated renal diseases.
4. Cash position of $107.6 million as of June 30, 2024, expected to fund operations through four Phase 2 clinical milestones and into mid-2026.
5. Q2 2024 net loss of $17.0 million, or $1.42 per share, compared to $5.8 million, or $16.69 per share, in Q2 2023.
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