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• An early-stage Amgen, focused on developing new immunotherapies for autoimmune diseases.
• A startup drug developer aiming to lead in autoimmune treatments, much like Vertex Pharmaceuticals became a leader in cystic fibrosis.
• A clinical-stage biotechnology company pioneering advanced antibody and protein therapies for immune system disorders, similar to a nascent Regeneron.

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• ADX-097: A clinical-stage C3 complement inhibitor being developed for serious autoimmune and inflammatory diseases driven by overactivation of the complement system.
• ADX-914: A clinical-stage, tissue-targeted IL-7R antagonist designed to modulate T-cell activity in specific autoimmune disorders.

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Q32 Bio (symbol: QTTB) is a clinical-stage biotechnology company focused on developing therapeutics for autoimmune and inflammatory diseases. As a company primarily engaged in research and development and conducting clinical trials for its drug candidates, Q32 Bio does not currently have "major customers" in the traditional commercial sense of selling products or services.

At its current stage, Q32 Bio's operations are centered on advancing its pipeline through preclinical and clinical development. Therefore, it does not sell products to other companies or individuals.

In the future, should its drug candidates receive regulatory approval and be commercialized, its potential "customers" or partners would typically be:

• Large pharmaceutical companies interested in licensing, acquiring, or co-developing their approved therapies for broader market distribution.
• Healthcare systems, hospitals, and specialty pharmacies, which would purchase and dispense the medications to patients.
• Government agencies or private health insurers that would provide coverage for the cost of their therapies.

However, at this time, Q32 Bio is not generating revenue from sales to such entities, as its therapies are still under development.

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KBI Biopharma, Inc.

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Jodie Morrison, Chief Executive Officer and Board Member

Jodie Morrison brings extensive biopharmaceutical leadership experience, having served as Chief Executive Officer of Cadent Therapeutics until its acquisition by Novartis in 2020. She was also a Venture Partner at Atlas Venture and held interim CEO and COO roles at Keryx Biopharmaceuticals, Inc. (where she executed a merger with Akebia Therapeutics, Inc.) and Syntimmune, Inc., respectively.

Lee Kalowski, President and Chief Financial Officer

Lee Kalowski has over 20 years of biopharmaceutical experience with a focus on strategy, capital raising, and financial operations. Prior to his current role, he was President and Chief Financial Officer at Bicycle Therapeutics from 2017-2023, where he was instrumental in supporting the company's transition to a public clinical-stage biotech company.

Shelia Violette, Co-founder, Chief Scientific Officer and President of Research

Shelia Violette is a scientific leader with expertise in inflammation, autoimmunity, and fibrosis. She is a co-founder of Q32 Bio.

Adrien Sipos, Interim Chief Medical Officer

Adrien Sipos was appointed Interim Chief Medical Officer in June 2025. She is an immunologist and an experienced Immunology and Inflammation (I&I) drug developer with over 25 years of leadership experience in clinical development and medical affairs. Previously, she served as President and Chief Medical Officer at PRAXICO Inc., where she provided clinical development advice to biopharmaceutical companies.

Vijay Kuchroo, Co-founder and Scientific Advisor

Vijay Kuchroo is an Indian-American immunologist and entrepreneur. He is the Samuel L. Wasserstrom Professor of Neurology at Harvard Medical School and Brigham & Women's Hospital, and the founding Director of The Gene Lay Institute of Immunology and Inflammation. Dr. Kuchroo has founded five different biotech companies, including CoStim Pharmaceuticals and Tempero Pharmaceuticals, and holds 25 patents.

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The key risks for Q32 Bio (symbol: QTTB) are primarily centered around its clinical development, financial stability, and regulatory hurdles, typical for a clinical-stage biotechnology company.

1. Clinical Trial Outcomes: As a clinical-stage biotech, Q32 Bio's valuation and future prospects are highly dependent on the success of its drug candidates in clinical trials. The company has recently faced significant setbacks, including the discontinuation of bempikibart (ADX-914) development for atopic dermatitis following disappointing Phase 2a trial results. While exploring ways to enhance bempikibart's efficacy for alopecia areata, analysts caution that this approach carries high risks, especially given the crowded competitive landscape with existing effective treatments. Any future trial failures, delays, or unexpected costs for its remaining pipeline could substantially impact investor confidence and the company's valuation.
2. Cash Burn and Need for Additional Funding: Q32 Bio operates with persistent negative free cash flow and no revenue, leading to significant cash burn. The company has a limited cash runway, despite a recent asset sale (ADX-097) to extend it, and will likely require further capital raises. Such fundraising activities often involve issuing new equity, which would dilute current shareholders and could put pressure on the stock price. The company's balance sheet also shows negative shareholder equity, indicating a precarious financial position.
3. Regulatory Uncertainty and Approvals: The drug development process involves inherent regulatory risks. Authorities like the FDA or EMA could demand additional studies, identify safety concerns, or delay approvals, thereby extending timelines and increasing development costs. This uncertainty can significantly impact the commercial viability of Q32 Bio's drug candidates, even if clinical trials show promise.

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The development and advanced clinical progress of Novartis' oral Factor B inhibitor, iptacopan. As an oral therapy targeting the same complement pathway (Factor B) as Q32 Bio's lead candidate ADX-097, iptacopan presents a significant convenience advantage over ADX-097's subcutaneous administration. Novartis has already achieved regulatory approvals (e.g., for PNH) and has reported positive late-stage data for other indications that Q32 Bio is pursuing (e.g., IgA nephropathy). This direct competition with a potentially more patient-friendly formulation poses a clear and emerging threat to ADX-097's future market share and commercial potential.

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Expected drivers of future revenue growth for Q32 Bio (QTTB) over the next 2-3 years are primarily centered on the clinical development and potential commercialization of its lead drug candidates, alongside strategic partnerships:

1. Advancement and Potential Commercialization of Bempikibart for Alopecia Areata (AA): Q32 Bio's lead immunology asset, bempikibart (ADX-914), is currently in a Phase 2a clinical trial (SIGNAL-AA) for severe or very severe alopecia areata. Part B enrollment for this trial was completed in October 2025, with topline data anticipated in the first half of 2026. Positive results from this trial and subsequent progression into pivotal (Phase 3) trials, coupled with the Fast Track designation received from the FDA for AA, could accelerate regulatory approval and eventual market launch, generating product revenue.
2. Advancement and Potential Commercialization of Bempikibart for Atopic Dermatitis (AD): Bempikibart is also being evaluated in a Phase 2 clinical trial (SIGNAL-AD) for moderate to severe atopic dermatitis. Enrollment for the SIGNAL-AD trial was completed, exceeding targets, and topline results were expected in Q4 2024. Successful progression through clinical trials and potential regulatory approval would open up another significant market for the company's lead product.
3. Formation of Strategic Partnerships and Collaborations: As a clinical-stage biotechnology company with no current product revenue, Q32 Bio's future revenue growth could significantly benefit from strategic partnerships. Collaborations for the development, funding, or commercialization of bempikibart or its other pipeline assets, such as ADX-097, could provide substantial non-dilutive capital, milestone payments, and future royalty streams, bolstering the company's financial runway into 2027.
4. Progression of the ADX-097 Program in Renal Basket Diseases: Although Q32 Bio restructured in February 2025 to primarily focus on bempikibart, the company has plans for Phase 2 trials for ADX-097, a program targeting the complement system, in renal basket diseases. Positive data and successful advancement of ADX-097 in these trials could attract partnerships or eventually lead to product commercialization, diversifying the company's potential revenue sources beyond bempikibart.

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Share Issuance

• Q32 Bio completed a merger with Homology Medicines, Inc. in March 2024, which included a cash infusion of $42.0 million from a pre-closing financing.
• The number of shares outstanding for Q32 Bio increased by 256.57% in one year.
• Q32 Bio had 12.20 million shares outstanding as of sometime in 2025.

Inbound Investments

• Q32 Bio raised a total of $106 million across two funding rounds, including a $60 million Series B round and a $46 million Series A round.
• Significant investors in these rounds include Orbimed, Acorn Bioventures, and Atlas Venture, with Orbimed and Acorn Bioventures as lead investors in the Series B round (October 2020) and Atlas Venture and Orbimed in the Series A round (May 2020).
• A merger with Homology Medicines in March 2024 resulted in a cash infusion of $42.0 million from a pre-closing financing.

Outbound Investments

• Q32 Bio's long-term investments were $3 million in 2024 and $26 million in 2022.

Capital Expenditures

• Q32 Bio reported capital expenditures of -$60,000 in the last 12 months.