Q32 Bio Reports Third Quarter 2024 Financial Results and Provides Corporate Update
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) ha riportato i risultati finanziari del Q3 2024 con 89,1 milioni di dollari in liquidità e equivalenti di liquidità al 30 settembre 2024, previsti per finanziare le operazioni fino a metà 2026. L'azienda prevede i risultati preliminari di due studi di Fase 2 su bempikibart per la dermatite atopica e l'alopecia areata a dicembre 2024. Nel Q3 ha registrato una perdita netta di 17,6 milioni di dollari, con le spese per R&S che sono aumentate a 14,3 milioni di dollari rispetto ai 7,5 milioni dell'anno precedente. Continua l'arruolamento nella sperimentazione ADX-097 di Fase 2 per le malattie renali mediate dal complemento, con i dati iniziali previsti per la prima metà del '25 e i risultati preliminari nella seconda metà del '25.
Q32 Bio (NASDAQ: QTTB) reportó resultados financieros del tercer trimestre de 2024 con 89,1 millones de dólares en efectivo y equivalentes de efectivo al 30 de septiembre de 2024, que se espera financien las operaciones hasta mediados de 2026. La compañía anticipa resultados preliminares de dos ensayos de Fase 2 de bempikibart en dermatitis atópica y alopecia areata en diciembre de 2024. En el tercer trimestre, se registró una pérdida neta de 17,6 millones de dólares, con gastos de I+D aumentando a 14,3 millones de dólares desde 7,5 millones del año anterior. La inscripción continúa en el ensayo de cesto de Fase 2 ADX-097 para enfermedades renales mediadas por complemento, con datos iniciales esperados en la primera mitad de '25 y resultados preliminares en la segunda mitad de '25.
Q32 Bio (NASDAQ: QTTB)는 2024년 3분기 재무 결과를 발표하며 2024년 9월 30일 기준으로 8,910만 달러의 현금 및 현금성 자산을 보유하고 있으며, 이는 2026년 중반까지 운영 자금을 지원할 것으로 예상합니다. 이 회사는 2024년 12월에 아토피 피부염 및 원형 탈모증에 대한 bempikibart의 두 개의 2상 시험에서 초기 결과를 예측하고 있습니다. 3분기에는 1,760만 달러의 순손실을 기록했으며, 연구개발 비용은 전년 대비 7.5백만 달러에서 1,430만 달러로 증가했습니다. ADX-097 2상 바스켓 시험에 대한 등록이 계속되고 있으며, 초기 데이터는 '25년 상반기에 예상되며, 초기 결과는 '25년 하반기에 예상됩니다.
Q32 Bio (NASDAQ: QTTB) a publié ses résultats financiers du troisième trimestre 2024, avec 89,1 millions de dollars en liquidités et équivalents de liquidités au 30 septembre 2024, prévus pour financer les opérations jusqu'à mi-2026. La société prévoit des résultats préliminaires de deux essais de phase 2 de bempikibart pour la dermatite atopique et l'alopécie areata en décembre 2024. Le troisième trimestre a enregistré une perte nette de 17,6 millions de dollars, les dépenses en R&D ayant augmenté à 14,3 millions de dollars contre 7,5 millions de dollars l'année précédente. L'inscription se poursuit dans l'essai ADX-097 de phase 2 pour les maladies rénales médiées par complément, avec des données préliminaires attendues dans la première moitié de '25 et des résultats globaux dans la seconde moitié de '25.
Q32 Bio (NASDAQ: QTTB) berichtete über die finanziellen Ergebnisse des 3. Quartals 2024 mit 89,1 Millionen US-Dollar an Cash und liquiden Mitteln zum 30. September 2024, die voraussichtlich bis Mitte 2026 für den Betrieb ausreichen werden. Das Unternehmen erwartet die Vorab-Ergebnisse aus zwei Phase-2-Studien zu bempikibart bei atopischer Dermatitis und Alopecia areata im Dezember 2024. Im 3. Quartal gab es einen Nettverlust von 17,6 Millionen US-Dollar, wobei die F&E-Ausgaben von 7,5 Millionen auf 14,3 Millionen US-Dollar im Vergleich zum Vorjahr gestiegen sind. Die Rekrutierung für die ADX-097 Phase-2-Studie bei komplementvermittelten Nierenerkrankungen läuft weiter, und erste Daten werden in der ersten Jahreshälfte '25 erwartet, während die Vorab-Ergebnisse in der zweiten Jahreshälfte '25 erwartet werden.
- Cash position of $89.1M provides runway through four Phase 2 clinical milestones into mid-2026
- Over-enrollment achieved in AD trial with 121 patients vs initial target of 100
- On track to deliver multiple Phase 2 trial results in December 2024
- Net loss increased to $17.6M from $14.0M year-over-year
- R&D expenses nearly doubled to $14.3M from $7.5M year-over-year
- G&A expenses increased to $4.5M from $2.2M year-over-year
Insights
Q32 Bio's Q3 report shows significant financial metrics and clinical progress. With
The upcoming December readouts for bempikibart in both AD and AA trials represent major catalysts. The over-enrollment in the AD trial (121 vs 100 planned patients) suggests strong investigator interest. The company's strategic positioning in both immunology and complement-mediated diseases provides multiple shots on goal, though cash burn requires monitoring given the extensive clinical program.
The clinical development strategy shows promising advancement with multiple parallel programs. Bempikibart's dual mechanism targeting IL-7Rα to block both IL-7 and TSLP signaling represents a novel approach in autoimmune conditions. The SIGNAL-AD trial's robust design with 121 patients and the EASI score primary endpoint aligns with regulatory standards.
ADX-097's tissue-targeted complement inhibition approach is particularly noteworthy, as it aims to address the challenge of systemic complement blockade. The positive Phase 1 data presented at ASN and the expansion into multiple indications (IgAN, LN, C3G and planned AAV) demonstrates the platform's potential versatility in treating various renal diseases.
-- Bempikibart Phase 2 topline results in atopic dermatitis (AD) and alopecia areata (AA) remain on-track for Q4'24, with topline data from both trials expected in December --
-- Enrollment ongoing in ADX-097 Phase 2 basket trial for complement mediated renal diseases, with topline data expected in 2H'25 and initial open-label data in 1H'25 --
-- Cash and cash equivalents of
"In the third quarter of 2024, we continued to make important strides advancing our two Phase 2 clinical trials evaluating bempikibart in AD and AA, with both trials remaining on-time, even with the over-enrollment in AD, and we remain focused on releasing topline data for both clinical trials this quarter," said Jodie Morrison, Chief Executive Officer of Q32 Bio. "We believe bempikibart has the potential to bring a differentiated, disease-modifying treatment to patients with AD and AA and look forward to sharing our results. In parallel, we continue to advance our Phase 2 basket trial of ADX-097 in complement mediated renal diseases with initial open-label Phase 2 data expected in the first half of 2025 after we release bempikibart data this quarter, and we continue to expect topline results in the second half of 2025. Additionally, we are continuing our preparations to commence the ADX-097 Phase 2 trial in ANCA-Associated Vasculitis (AAV) in the first half of 2025."
Third Quarter 2024 and Recent Business Highlights
- Bempikibart SIGNAL-AD Phase 2 clinical trial in AD remains on-track, with topline results expected to be released in December 2024. Bempikibart is a fully human anti-IL-7Rα antibody that is designed to re-regulate adaptive immune function by blocking IL-7 and TSLP signaling, both of which contribute to inflammation and injury in a diversity of autoimmune disorders. SIGNAL-AD is a two-part Phase 2, randomized, double-blind, placebo-controlled, multi-center clinical trial evaluating bempikibart in adult patients with persistent, moderate-to-severe AD. Part A was conducted to evaluate safety, PK, and to enable dose selection for Part B of the clinical trial. Part A was completed, but data remains blinded. Part B is being conducted to evaluate the efficacy and safety of bempikibart as compared with placebo. In Part B, patients were enrolled 1:1 in the bempikibart 200 mg every-other-week (Q2W) subcutaneous (SC) flat dose and placebo arms for 12 weeks of treatment. The primary endpoint is the mean percent change from baseline to week 14 in the Eczema Area and Severity Index (EASI) score. Patients will be followed for an additional 12 weeks following completion of treatment. A total of 121 patients were enrolled, including 15 patients in Part A. Total enrollment exceeded the initial target of approximately 100 patients due to Part B patient enrollment demand.
- Bempikibart SIGNAL-AA Phase 2 clinical trial in AA remains on track, with topline results expected in December 2024. SIGNAL-AA is a Phase 2, randomized, double-blind, placebo-controlled, multi-center clinical trial evaluating bempikibart in patients with severe AA treated over 24 weeks. Patients were randomized 3:1 in the bempikibart 200 mg Q2W SC flat dose and placebo arms. The primary endpoint is the mean percent change from baseline on the Severity of Alopecia Tool (SALT) score at week 24. Patients will be followed for an additional 12 weeks following completion of treatment.
- Enrollment is underway in the Phase 2 basket trial of ADX-097 for complement mediated renal diseases. ADX-097 is designed to be a tissue-targeted inhibitor of complement activation while minimizing systemic complement blockade and is being studied for the treatment of patients with renal diseases associated with increased complement activation. The Phase 2 open label clinical trial is evaluating the safety, pharmacodynamics, pharmacokinetics, and clinical activity of ADX-097 administered subcutaneously in participants with IgA Nephropathy (IgAN), Lupus Nephritis (LN), or C3 Glomerulopathy (C3G). Initial open-label data is expected in the first half of 2025, and topline results expected in the second half of 2025. Q32 Bio also plans to evaluate ADX-097 in a Phase 2 clinical trial in ANCA-Associated Vasculitis (AAV), which is expected to commence in the first half of 2025 with topline results also expected in the second half of 2025.
- Positive Phase 1 clinical trial results from tissue-targeted complement inhibitor ADX-097 were presented at ASN Kidney Week 2024. The poster presentation at ASN highlighted data from the first-in-human, Phase 1 ascending dose clinical trial of ADX-097 in healthy volunteers. ADX-097 demonstrated a favorable safety profile and desired PK/PD properties, supporting a Phase 2 dose that is predicted to provide tissue inhibition of complement in glomerular diseases while sparing systemic complement activity.
Financial Results
- Cash and cash equivalents were
$89.1 million
- Research and development expenses were
$14.3 million $7.5 million $6.8 million $4.0 million
- General and administrative expenses were
$4.5 million $2.2 million $2.3 million
- Net loss was
$17.6 million $1.46 $14.0 million $40.52
About Q32 Bio
Q32 Bio is a clinical stage biotechnology company developing biologic therapeutics targeting potent regulators of the innate and adaptive immune systems to re-balance immunity in autoimmune and inflammatory diseases. Q32 Bio's lead programs, focused on the IL-7 / TSLP receptor pathways and complement system, address immune dysregulation to help patients take back control of their lives.
Q32 Bio's program for adaptive immunity, bempikibart (ADX-914), is a fully human anti-IL-7Rα antibody that re-regulates adaptive immune function for the treatment of autoimmune diseases. It is being evaluated in two Phase 2 trials for the treatment of atopic dermatitis and alopecia areata. The IL-7 and TSLP pathways have been genetically and biologically implicated in driving several T cell-mediated pathological processes in numerous autoimmune diseases. Q32 Bio's program for innate immunity, ADX-097, is based on a novel platform enabling tissue-targeted regulation of the complement system without long-term systemic blockade – a key differentiator versus current complement therapeutics. Q32 Bio has completed a first-in-human, Phase 1 ascending dose clinical study of ADX-097 in healthy volunteers.
For more information, visit www.Q32Bio.com.
Availability of Other Information About Q32 Bio
Investors and others should note that we communicate with our investors and the public using our company website www.Q32Bio.com, including, but not limited to, company disclosures, investor presentations and FAQs, Securities and Exchange Commission filings, press releases, public conference call transcripts and webcast transcripts, as well as on X (formerly Twitter) and LinkedIn. The information that we post on our website or on X or LinkedIn could be deemed to be material information. As a result, we encourage investors, the media and others interested to review the information that we post there on a regular basis. The contents of our 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
Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "anticipate," "plan," "likely," "believe," "estimate," "project," "intend," and other similar expressions among others. Statements that are not historical facts are forward-looking statements. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: interim, topline and preliminary data may change as more patient data become available, and are subject to audit and verification procedures that could result in material changes in the final data; data generated from our preclinical and clinical studies including our Phase 2 clinical trials of bempikibart and ADX-097, may not meet our expectations; our product candidates may not provide the intended therapeutic benefits; our product candidates may cause serious adverse side effects; our ability to retain, attract and hire key personnel; potential business uncertainty, including changes to existing business relationships that could affect our financial performance; the need for additional funding, which may not be available; failure to identify additional product candidates and develop or commercialize marketable products; the early stage of our development efforts; potential unforeseen events during clinical trials could cause delays or other adverse consequences; risks relating to the regulatory approval process; the inability to maintain our collaborations, or the failure of these collaborations; our reliance on third parties, including for the manufacture of materials for our research programs, preclinical and clinical studies; failure to obtain U.S. or international marketing approval; ongoing regulatory obligations; effects of significant competition; unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives; product liability lawsuits; securities class action litigation; the impact of global pandemics and general economic conditions on our business and operations, including the our preclinical studies and clinical trials; the possibility of system failures or security breaches; risks relating to intellectual property; significant costs incurred as a result of operating as a public company; and such other factors as are set forth in Q32 Bio's periodic public filings with the SEC, including but not limited to those described under the heading "Risk Factors" in our Form 10-Q filed with the Securities and Exchange Commission on August 8, 2024 and any subsequent filings made with the Securities and Exchange Commission. Except as required by applicable law, we undertake no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.
Q32 BIO INC. | ||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||
(in thousands, except share and per share amounts) | ||||||||
(Unaudited) | ||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||
2024 | 2023 | 2024 | 2023 | |||||
Collaboration arrangement revenue | $ — | $ 1,859 | $ — | $ 8,011 | ||||
Operating expenses: | ||||||||
Research and development | 14,346 | 7,463 | 37,598 | 23,390 | ||||
General and administrative | 4,468 | 2,194 | 13,978 | 7,067 | ||||
Total operating expenses | 18,814 | 9,657 | 51,576 | 30,457 | ||||
Loss from operations | (18,814) | (7,798) | (51,576) | (22,446) | ||||
Change in fair value of convertible notes | — | (6,252) | 15,890 | (4,992) | ||||
Other income (expense), net | 1,219 | 84 | 3,767 | 827 | ||||
Total other income (expense), net | 1,219 | (6,168) | 19,657 | (4,165) | ||||
Loss before provision for income taxes | (17,595) | (13,966) | (31,919) | (26,611) | ||||
Provision for income taxes | — | (65) | — | (65) | ||||
Loss from equity method investment | — | — | (1,625) | — | ||||
Net loss | $ (17,595) | $ (14,031) | $ (33,544) | $ (26,676) | ||||
Net loss per share—basic | $ (1.46) | $ (40.52) | $ (4.01) | $ (76.81) | ||||
Net loss per share—diluted | $ (1.46) | $ (40.52) | $ (5.60) | $ (76.81) | ||||
Weighted-average common shares—basic | 12,076,412 | 346,288 | 8,360,652 | 347,292 | ||||
Weighted-average common shares—diluted | 12,076,412 | 346,288 | 8,810,555 | 347,292 | ||||
Q32 BIO INC. | ||||
CONDENSED CONSOLIDATED BALANCE SHEETS | ||||
(in thousands) | ||||
(Unaudited) | ||||
September 30, | December 31, | |||
Assets | ||||
Cash and cash equivalents | $ 89,078 | $ 25,617 | ||
Equity investment | 2,600 | — | ||
Right-of-use asset, operating leases | 5,869 | 6,301 | ||
Restricted cash and restricted cash equivalents | 647 | 5,647 | ||
Other assets | 6,348 | 9,492 | ||
Total assets | $ 104,542 | $ 47,057 | ||
Liabilities, convertible preferred stock and stockholders' deficit | ||||
Accounts payable, accrued expenses and other current liabilities | $ 10,170 | $ 13,231 | ||
CVR liability | 2,680 | — | ||
Lease liability, net of current portion | 5,793 | 6,248 | ||
Venture debt | 12,604 | 5,459 | ||
Convertible notes | — | 38,595 | ||
Other noncurrent liabilities | 55,000 | 55,000 | ||
Convertible preferred stock | — | 111,445 | ||
Stockholders' equity (deficit) | 18,295 | (182,921) | ||
Total liabilities, convertible preferred stock and stockholders' equity (deficit) | $ 104,542 | $ 47,057 | ||
Contacts:
Investors: Brendan Burns
Media: Sarah Sutton
Argot Partners
212.600.1902
Q32Bio@argotpartners.com
View original content to download multimedia:https://www.prnewswire.com/news-releases/q32-bio-reports-third-quarter-2024-financial-results-and-provides-corporate-update-302298699.html
SOURCE Q32 Bio
FAQ
What were Q32 Bio's (QTTB) Q3 2024 financial results?
When will Q32 Bio (QTTB) release bempikibart Phase 2 trial results?
How long will Q32 Bio's (QTTB) current cash runway last?
