QTTB 8-K
Q32 Bio Inc. (QTTB)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
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 May 8, 2025, Q32 Bio Inc. announced its financial results for the quarter ended March 31, 2025 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: |
May 8, 2025 |
By: |
/s/ Jodie Morrison |
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Name: Title: |
Jodie Morrison |
Exhibit 99.1
Q32 Bio Reports First Quarter 2025 Financial Results and Provides Corporate Update
-- First patient dosed in SIGNAL-AA Phase 2a Part B; topline data readout on-track for 1H’26 --
-- First patient dosed in SIGNAL-AA Part A open label extension (OLE) --
-- Fast Track designation (FTD) granted to bempikibart for the treatment of alopecia areata (AA); SIGNAL-AA Part A results presented as a late-breaking oral presentation at the 2025 American Academy of Dermatology (AAD) Annual Meeting --
-- Cash and cash equivalents of $65.5 million as of March 31, 2025 expected to provide financial runway into 2H’26 --
WALTHAM, Mass.—May 8, 2025 – Q32 Bio Inc. (Nasdaq: QTTB) (“Q32 Bio”), a clinical stage biotechnology company focused on developing innovative therapies for alopecia areata and other autoimmune and inflammatory diseases, today reported financial results for the quarter ended March 31, 2025, and provided recent corporate updates.
“This past quarter brought exciting momentum for Q32 Bio and bempikibart as we received Fast Track designation, presented results as a late-breaking oral presentation at AAD, and advanced our SIGNAL-AA Phase 2a clinical trial, dosing the first patients in both Part B and the Part A OLE. These steps reflect our ongoing progress and commitment to developing bempikibart as a potential treatment for patients with alopecia areata who need new treatment options,” said Jodie Morrison, Chief Executive Officer of Q32 Bio. “We look forward to sharing topline data from Part B in the first half of next year and continuing our efforts to advance bempikibart.”
First Quarter 2025 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 data reported to date from Part A of the SIGNAL-AA Phase 2a clinical trial, 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, the potential benefits conferred by FTD for bempikibart, 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 second half of 2026; 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 the first half of 2026 or at all, might be more costly than expected or might not yield anticipated results, that FTD by the FDA may not actually lead to a faster development or regulatory review or approval process, 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 Annual Report on Form 10-K for the year ended December 31, 2024 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 March 31, |
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2025 |
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2024 |
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Operating expenses: |
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Research and development |
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$ |
7,124 |
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$ |
9,841 |
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General and administrative |
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5,104 |
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5,002 |
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Total operating expenses |
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12,228 |
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14,843 |
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Loss from operations |
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(12,228 |
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(14,843 |
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Change in fair value of convertible notes |
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— |
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15,890 |
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Other income (expense), net |
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1,197 |
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158 |
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Total other income (expense), net |
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1,197 |
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16,048 |
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Income (loss) before provision for income taxes and loss from equity method investment |
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(11,031 |
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1,205 |
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Provision for income taxes |
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— |
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— |
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Loss from equity method investment |
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— |
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(176 |
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Net income (loss) |
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$ |
(11,031 |
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$ |
1,029 |
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Net income (loss) per share—basic |
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$ |
(0.90 |
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$ |
1.03 |
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Net income (loss) per share—diluted |
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$ |
(0.90 |
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$ |
(6.33 |
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Weighted-average common shares—basic |
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12,197,615 |
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995,280 |
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Weighted-average common shares—diluted |
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12,197,615 |
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2,334,180 |
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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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(Unaudited) |
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March 31, |
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December 31, |
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Assets |
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Cash and cash equivalents |
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$ |
65,483 |
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$ |
77,965 |
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Equity investment |
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2,526 |
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2,600 |
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Right-of-use asset, operating leases |
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5,571 |
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5,722 |
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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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4,844 |
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5,398 |
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Total assets |
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$ |
79,071 |
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$ |
92,332 |
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Liabilities and stockholders’ equity (deficit) |
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Accounts payable, accrued expenses and other current liabilities |
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$ |
7,977 |
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$ |
10,468 |
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CVR liability |
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1,940 |
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2,900 |
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Lease liability, net of current portion |
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5,467 |
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5,636 |
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Venture debt |
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12,701 |
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12,653 |
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Other noncurrent liabilities |
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55,000 |
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55,000 |
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Stockholders’ equity (deficit) |
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(4,014 |
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5,675 |
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Total liabilities and stockholders’ equity (deficit) |
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$ |
79,071 |
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$ |
92,332 |
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