-- 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-7R<ALPHA> 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 areata(1) , 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-7R<ALPHA> 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.
(1) National 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.
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