QTTB 8-K
Q32 Bio Inc. (QTTB)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On August 5, 2026, Q32 Bio Inc. announced its financial results for the quarter ended June 30, 2026 and provided a corporate update. A copy of the press release in connection with the announcement is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Current Report on Form 8-K (including Exhibit 99.1 attached hereto) is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
99.1 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Q32 BIO INC. |
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Date: |
August 5, 2026 |
By: |
/s/ Jodie Morrison |
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Name: Title: |
Jodie Morrison |
Q32 Bio Reports Second Quarter 2026 Financial Results and Provides Corporate Update
-- 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.— August 5, 2026 – 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
Financial Results
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 Burns
Argot Partners
212.600.1902
[email protected]
Media: David Rosen
Argot Partners
646.461.6387
[email protected]
Q32 BIO INC. |
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
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(in thousands, except share and per share amounts) |
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(Unaudited) |
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2026 |
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2025 |
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2026 |
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2025 |
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Operating expenses: |
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Research and development |
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$ |
4,259 |
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$ |
5,161 |
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$ |
7,477 |
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$ |
12,286 |
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General and administrative |
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4,859 |
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4,010 |
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9,363 |
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9,114 |
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Total operating expenses |
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9,118 |
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9,171 |
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16,840 |
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21,400 |
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Loss from operations |
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(9,118 |
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(9,171 |
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(16,840 |
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(21,400 |
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Loss on extinguishment of debt |
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(147 |
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— |
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(147 |
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— |
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Other income (expense), net |
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319 |
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(318 |
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432 |
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880 |
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Total other income (expense), net |
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172 |
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(318 |
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285 |
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880 |
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Net loss and comprehensive loss |
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$ |
(8,946 |
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$ |
(9,489 |
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$ |
(16,555 |
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$ |
(20,520 |
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Net loss per share—basic and diluted |
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$ |
(0.44 |
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$ |
(0.78 |
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$ |
(0.96 |
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$ |
(1.68 |
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Weighted-average common shares—basic and diluted |
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20,342,345 |
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12,197,615 |
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17,265,864 |
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12,197,615 |
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Q32 BIO INC. |
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CONDENSED CONSOLIDATED BALANCE SHEETS |
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(in thousands) |
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June 30, |
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December 31, |
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(Unaudited) |
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Assets |
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Cash and cash equivalents |
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$ |
106,270 |
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$ |
48,297 |
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Right-of-use asset, operating leases |
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4,770 |
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5,100 |
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Restricted cash and restricted cash equivalents |
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647 |
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647 |
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Other assets |
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4,180 |
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7,732 |
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Total assets |
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$ |
115,867 |
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$ |
61,776 |
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Liabilities and stockholders’ equity |
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Accounts payable, accrued expenses and other current liabilities |
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$ |
5,401 |
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$ |
5,111 |
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Lease liability, net of current portion |
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4,561 |
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4,943 |
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Venture debt |
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— |
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9,708 |
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Stockholders’ equity |
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105,905 |
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42,014 |
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Total liabilities and stockholders’ equity |
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$ |
115,867 |
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$ |
61,776 |
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