Q32 Bio Reports Fourth Quarter 2024 Financial Results and Provides Corporate Update
Q32 Bio (QTTB) has reported its Q4 2024 financial results and provided corporate updates. The company presented encouraging Phase 2a Part A data for bempikibart in treating alopecia areata (AA) at the 2025 AAD Annual Meeting. The drug demonstrated meaningful clinical activity at week 24 with continued effects after dosing cessation, showing potential as a differentiated AA treatment.
Key financial metrics include cash and equivalents of $78.0 million as of December 31, 2024, providing runway into 2H'26. Q4 2024 saw R&D expenses of $10.5 million (up from $8.3M YoY) and G&A expenses of $4.0 million (up from $2.8M YoY). Net loss was $14.2 million ($1.16 per share).
The company is advancing two key initiatives: the SIGNAL-AA open-label extension and SIGNAL-AA Part B, both scheduled to dose patients in 1H'25, with Part B topline data expected in 1H'26.
Q32 Bio (QTTB) ha riportato i risultati finanziari del quarto trimestre 2024 e fornito aggiornamenti aziendali. L'azienda ha presentato dati incoraggianti della fase 2a parte A per bempikibart nel trattamento dell'alopecia areata (AA) durante il Meeting Annuale AAD 2025. Il farmaco ha dimostrato un'attività clinica significativa alla settimana 24, con effetti continuati dopo la cessazione della somministrazione, mostrando potenziale come trattamento differenziato per l'AA.
I principali indicatori finanziari includono liquidità e equivalenti di 78,0 milioni di dollari al 31 dicembre 2024, garantendo un margine di operatività fino alla seconda metà del 2026. Nel quarto trimestre 2024, le spese per R&S sono state di 10,5 milioni di dollari (in aumento rispetto agli 8,3 milioni dell'anno precedente) e le spese generali e amministrative di 4,0 milioni di dollari (in aumento rispetto ai 2,8 milioni dell'anno precedente). La perdita netta è stata di 14,2 milioni di dollari (1,16 dollari per azione).
L'azienda sta portando avanti due iniziative chiave: l'estensione open-label SIGNAL-AA e la parte B di SIGNAL-AA, entrambe programmate per somministrare ai pazienti nella prima metà del 2025, con i dati principali della parte B attesi nella prima metà del 2026.
Q32 Bio (QTTB) ha informado sus resultados financieros del cuarto trimestre de 2024 y proporcionado actualizaciones corporativas. La compañía presentó datos alentadores de la fase 2a parte A para bempikibart en el tratamiento de la alopecia areata (AA) en la Reunión Anual AAD 2025. El medicamento demostró una actividad clínica significativa a la semana 24, con efectos continuos tras la cesación de la dosificación, mostrando potencial como un tratamiento diferenciado para la AA.
Los principales indicadores financieros incluyen efectivo y equivalentes de 78,0 millones de dólares al 31 de diciembre de 2024, proporcionando un margen de operación hasta la segunda mitad de 2026. En el cuarto trimestre de 2024, los gastos de I+D fueron de 10,5 millones de dólares (un aumento desde los 8,3 millones interanuales) y los gastos generales y administrativos fueron de 4,0 millones de dólares (un aumento desde los 2,8 millones interanuales). La pérdida neta fue de 14,2 millones de dólares (1,16 dólares por acción).
La compañía está avanzando en dos iniciativas clave: la extensión de etiqueta abierta SIGNAL-AA y la parte B de SIGNAL-AA, ambas programadas para dosificar pacientes en la primera mitad de 2025, con los datos principales de la parte B esperados en la primera mitad de 2026.
Q32 Bio (QTTB)는 2024년 4분기 재무 결과를 보고하고 기업 업데이트를 제공했습니다. 이 회사는 2025년 AAD 연례 회의에서 bempikibart의 탈모증(AA) 치료를 위한 2a 단계 A 부분의 유망한 데이터를 발표했습니다. 이 약물은 24주 차에 의미 있는 임상 활동을 보여주었으며, 투여 중단 후에도 지속적인 효과를 나타내어 차별화된 AA 치료제로서의 가능성을 보여주었습니다.
주요 재무 지표로는 2024년 12월 31일 기준 현금 및 현금성 자산이 7,800만 달러에 달하며, 이는 2026년 하반기까지의 운영 자금을 제공합니다. 2024년 4분기 R&D 비용은 1,050만 달러(전년 대비 830만 달러에서 증가)였고, 일반 관리 비용은 400만 달러(전년 대비 280만 달러에서 증가)였습니다. 순손실은 1,420만 달러(주당 1.16달러)였습니다.
회사는 두 가지 주요 이니셔티브를 추진하고 있습니다: SIGNAL-AA 오픈 라벨 연장 및 SIGNAL-AA B 부분, 두 가지 모두 2025년 상반기에 환자에게 투여할 예정이며, B 부분의 주요 데이터는 2026년 상반기에 발표될 것으로 예상됩니다.
Q32 Bio (QTTB) a annoncé ses résultats financiers pour le quatrième trimestre 2024 et a fourni des mises à jour sur l'entreprise. La société a présenté des données encourageantes de la phase 2a partie A pour bempikibart dans le traitement de l'alopécie areata (AA) lors de la réunion annuelle de l'AAD 2025. Le médicament a montré une activité clinique significative à la semaine 24, avec des effets persistants après l'arrêt du traitement, montrant un potentiel en tant que traitement différencié pour l'AA.
Les principaux indicateurs financiers incluent des liquidités et équivalents de 78,0 millions de dollars au 31 décembre 2024, offrant une marge de manœuvre jusqu'au second semestre 2026. Le quatrième trimestre 2024 a vu des dépenses de R&D de 10,5 millions de dollars (en hausse par rapport à 8,3 millions de dollars d'une année sur l'autre) et des dépenses générales et administratives de 4,0 millions de dollars (en hausse par rapport à 2,8 millions de dollars d'une année sur l'autre). La perte nette était de 14,2 millions de dollars (1,16 dollar par action).
L'entreprise fait progresser deux initiatives clés : l'extension en open-label SIGNAL-AA et la partie B de SIGNAL-AA, toutes deux prévues pour administrer des traitements aux patients au premier semestre 2025, avec des données principales de la partie B attendues au premier semestre 2026.
Q32 Bio (QTTB) hat seine finanziellen Ergebnisse für das vierte Quartal 2024 bekannt gegeben und Unternehmensupdates bereitgestellt. Das Unternehmen präsentierte ermutigende Daten aus der Phase 2a Teil A für bempikibart zur Behandlung von Alopecia areata (AA) auf dem AAD Jahresmeeting 2025. Das Medikament zeigte in der Woche 24 eine signifikante klinische Aktivität mit anhaltenden Effekten nach Beendigung der Dosis, was Potenzial als differenziertes AA-Behandlungsmittel zeigt.
Wichtige Finanzkennzahlen umfassen Barmittel und Äquivalente in Höhe von 78,0 Millionen Dollar zum 31. Dezember 2024, die einen Spielraum bis zur zweiten Hälfte von 2026 bieten. Im vierten Quartal 2024 beliefen sich die F&E-Ausgaben auf 10,5 Millionen Dollar (ein Anstieg von 8,3 Millionen im Jahresvergleich) und die allgemeinen und administrativen Ausgaben auf 4,0 Millionen Dollar (ein Anstieg von 2,8 Millionen im Jahresvergleich). Der Nettoverlust betrug 14,2 Millionen Dollar (1,16 Dollar pro Aktie).
Das Unternehmen verfolgt zwei wichtige Initiativen: die SIGNAL-AA Open-Label-Erweiterung und SIGNAL-AA Teil B, die beide für die Dosierung von Patienten in der ersten Hälfte von 2025 geplant sind, wobei die Hauptdaten von Teil B in der ersten Hälfte von 2026 erwartet werden.
- Strong clinical efficacy data for bempikibart with continued patient response post-treatment
- Robust safety profile with no grade 3 or higher related adverse events
- Sufficient cash runway into 2H'26 covering key clinical milestones
- Significant reduction in net loss from $27.1M to $14.2M year-over-year
- Increased R&D expenses by $2.2M year-over-year
- Higher G&A expenses, up $1.2M compared to previous year
Insights
Q32 Bio's Q4 2024 results and pipeline update present several encouraging signals for this clinical-stage immunology company. The highlight is their lead candidate bempikibart showing notable clinical activity in alopecia areata (AA) with durable responses continuing after treatment cessation - a potentially significant differentiator in this therapeutic area.
The late-breaking presentation at AAD revealed compelling data: in a difficult-to-treat patient population with severe/very severe AA averaging 5+ years duration, bempikibart demonstrated not only meaningful activity during the 24-week treatment period but deepening responses after dosing ended. Among responsive patients followed beyond the trial period, all maintained or improved their hair regrowth, with 7 of 12 showing additional improvement post-treatment.
From a safety perspective, bempikibart appears well-tolerated with no grade 3+ related adverse events or viral infections - potentially addressing safety concerns with existing therapies. Pharmacologically, the drug demonstrated robust target engagement and expected T-cell modulation.
Financially, Q32 maintains a solid position with
With SIGNAL-AA OLE and Part B trials both set to dose patients in H1 2025 and topline data expected H1 2026, Q32 is positioned to build on their encouraging initial findings before their cash runway expires.
The bempikibart data presented at AAD reveals a potentially differentiated mechanism of action that addresses fundamental immunological dysfunction in alopecia areata. As an IL-7Rα antibody, this agent targets a pathway critical to T-cell homeostasis rather than providing broad immunosuppression.
The most scientifically intriguing aspect is the continued improvement after treatment cessation. This suggests bempikibart may be achieving actual immune rebalancing rather than simply suppressing inflammation while on therapy. The continued or improved responses observed up to 20 weeks post-treatment (median follow-up) aligns with the hypothesized mechanism of modulating the balance between T effector memory cells and T regulatory function.
The biomarker data further supports the drug's mechanism, showing robust receptor occupancy and changes in Th2 markers - critical immunological signals in AA pathogenesis. This pharmacological activity confirms dual inhibition of both IL-7 and TSLP signaling pathways, which may explain the differentiated clinical profile compared to existing therapies.
The clean safety profile without serious adverse events or viral infections is especially noteworthy given that current AA treatments carry significant safety concerns, including infection risks and other adverse effects. This favorable risk/benefit profile could position bempikibart as particularly valuable in a chronic condition requiring long-term management.
The decision to extend treatment to 36 weeks in Part B (versus 24 weeks in Part A) represents a thoughtful clinical development approach, potentially maximizing response rates while gathering additional safety data. If the durable post-treatment effect is confirmed in this larger cohort, it could suggest a paradigm shift in AA treatment - possibly enabling intermittent rather than continuous therapy.
-- Presented bempikibart SIGNAL-AA Phase 2a Part A alopecia areata (AA) data demonstrating encouraging clinical activity and highlighting the potential to be a differentiated treatment as a late-breaking oral presentation at the 2025 American Academy of Dermatology (AAD) Annual Meeting --
-- Advancing bempikibart in patients with AA, with SIGNAL-AA open-label extension (OLE) and SIGNAL-AA Part B on track to dose patients in 1H'25; SIGNAL-AA Part B topline data on-track for 1H'26 --
-- Cash and cash equivalents of
"We are pleased to have been selected to present our bempikibart Phase 2a Part A data at AAD as a late-breaking oral presentation, highlighting the encouraging clinical activity we have observed to date, including patients with continued responses in long-term follow-up months after completing treatment, robust pharmacologic data, and a well-tolerated safety profile. We believe this underscores the excitement amongst the dermatology community for bempikibart, recognizing its potential as a novel, differentiated approach for the treatment of AA compared to existing therapies, which are generally not associated with durable responses and carry significant safety concerns," said Jodie Morrison, Chief Executive Officer of Q32 Bio. "We look forward to building on this momentum as we advance bempikibart in the SIGNAL-AA OLE and SIGNAL-AA Part B portions of our Phase 2a clinical trial and remain on-track to dose patients in the first half of this year."
Fourth Quarter 2024 and Recent Business Highlights
- Presented results from SIGNAL-AA Phase 2a Part A clinical trial of bempikibart in alopecia areata (AA) as a late-breaking oral presentation at the 2025 American Academy of Dermatology (AAD) Annual Meeting. The late-breaking presentation highlighted additional results from Part A of the SIGNAL-AA Phase 2a clinical trial of bempikibart, a fully human anti-IL-7Rα antibody designed to re-regulate adaptive immune function by blocking IL-7 and TSLP signaling, beyond what was previously reported in the topline readout in December. In a difficult-to-treat severe and very severe patient population with an average duration of current episode greater than 5 years, bempikibart demonstrated clinically meaningful activity at week 24 and continued effects after dosing cessation. Despite only 24 weeks of bempikibart treatment, a deepening response, as measured by mean percent change in Severity of Alopecia Tool (SALT) compared with baseline, was observed following dosing cessation (week 24) through the post-treatment follow-up period (week 36), a paradigm believed to be associated with IL-7 on-mechanism modulation of rebalancing T effector memory cells and T regulatory function. Additional data has been collected on patients after week 36, with follow-up on multiple patients through week 55 to date, and additional long-term follow-up ongoing. Outreach was made to patients regarding the post-treatment experience and patients willing to participate were re-consented. Amongst patients responding to outreach that completed the treatment period and showed a SALT response during the trial (n=12), all achieved maintenance of response or further hair growth in the post treatment period (post 24 weeks), including after the end of the trial (post 36 weeks). All 12 were confirmed by SALT assessment by the investigator, with a median follow-up of 41 weeks to date (17 weeks post last treatment) with additional follow-up ongoing. Of these, seven patients (7/12) showed additional hair growth by SALT assessment post-treatment, with median follow-up of 44 weeks to date (20 weeks post last treatment) with additional follow-up ongoing. Across clinical trials, including SIGNAL-AA, bempikibart was observed to be safe and well-tolerated, with no grade 3 or higher related adverse events or related viral infections. Robust pharmacologic activity through desired target engagement was observed, as demonstrated by receptor occupancy, robust changes in Th2 biomarkers, and expected on-mechanism changes in T-cells, indicative of potent IL-7 and TSLP inhibition. The full AAD presentation is available on the "Presentations and Publications" page of the Q32 Bio website.
- Bempikibart SIGNAL-AA OLE remains on track to initiate in the first half of 2025. Based on continued emergence of bempikibart data demonstrating ongoing 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 is initiating an OLE following the same bempikibart dosing regimen leveraged in Part A to enable longer-term follow up of patients, with dosing on-track for the first half of 2025.
- SIGNAL-AA Part B on track to initiate dosing in the first half of 2025, with topline data expected in the first half of 2026. SIGNAL-AA Part B is an open-label clinical trial, with expected bempikibart dosing for 36 weeks, with follow-up out to 52 weeks, in approximately 20 evaluable patients with severe or very severe AA. Dosing will include an initial loading regimen of 200mg of bempikibart dosed weekly over four weeks, followed by a maintenance dose of 200mg every-other-week over a 32-week period for a total of 36 weeks. Efficacy will be evaluated on the basis of mean percentage change from baseline in 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. The trial is intended to support advancement into pivotal trials upon completion, pending review of the results. Q32 Bio expects to initiate SIGNAL-AA Part B dosing in the first half of 2025 and report topline results in the first half of 2026.
Financial Results
- Cash and cash equivalents were
$78.0 million - Research and development expenses were
$10.5 million $8.3 million $2.2 million - General and administrative expenses were
$4.0 million $2.8 million $1.2 million - Net loss was
$14.2 million $1.16 $27.1 million $76.39
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 in autoimmune and inflammatory diseases.
Q32 Bio is advancing bempikibart (ADX-914), a fully human anti-IL-7Rα antibody that re-regulates adaptive immune function for the treatment of autoimmune diseases being evaluated in a 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.
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 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 our current beliefs and expectations for bempikibart, future clinical studies, including that 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, our expectations regarding the sufficiency of our cash and cash equivalents to provide financial runway through clinical milestones and into the second half of 2026, 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 the Company's periodic, current and other filings with the
Contacts:
Investors: Brendan Burns
Media: Sarah Sutton
Argot Partners
212.600.1902
Q32Bio@argotpartners.com
Q32 BIO INC. | ||||
CONDENSED CONSOLIDATED BALANCE SHEETS | ||||
(in thousands) | ||||
December 31, | ||||
2024 | 2023 | |||
Assets | ||||
Cash and cash equivalents | $ 77,965 | $ 25,617 | ||
Equity investment | 2,600 | — | ||
Right-of-use asset, operating leases | 5,722 | 6,301 | ||
Restricted cash and restricted cash equivalents | 647 | 5,647 | ||
Other assets | 5,398 | 9,492 | ||
Total assets | $ 92,332 | $ 47,057 | ||
Liabilities, convertible preferred stock and stockholders' equity (deficit) | ||||
Accounts payable, accrued expenses and other current liabilities | $ 10,468 | $ 13,231 | ||
CVR liability | 2,900 | — | ||
Lease liability, net of current portion | 5,636 | 6,248 | ||
Venture debt | 12,653 | 5,459 | ||
Convertible notes | — | 38,595 | ||
Other noncurrent liabilities | 55,000 | 55,000 | ||
Convertible preferred stock | — | 111,445 | ||
Stockholders' equity (deficit) | 5,675 | (182,921) | ||
Total liabilities, convertible preferred stock and stockholders' equity (deficit) | $ 92,332 | $ 47,057 | ||
Q32 BIO INC. | ||||||||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||
(in thousands, except share and per share amounts) | ||||||||
Three Months Ended December 31, | Year Ended December 31, | |||||||
2024 | 2023 | 2024 | 2023 | |||||
(unaudited) | ||||||||
Collaboration arrangement revenue | $ — | $ (14,662) | $ — | $ (6,651) | ||||
Operating expenses: | ||||||||
Research and development | 10,545 | 8,339 | 48,143 | 31,729 | ||||
General and administrative | 3,981 | 2,808 | 17,959 | 9,875 | ||||
Total operating expenses | 14,526 | 11,147 | 66,102 | 41,604 | ||||
Loss from operations | (14,526) | (25,809) | (66,102) | (48,255) | ||||
Change in fair value of convertible notes | — | (1,201) | 15,890 | (6,193) | ||||
Other income (expense), net | 358 | 196 | 4,125 | 1,023 | ||||
Total other income (expense), net | 358 | (1,005) | 20,015 | (5,170) | ||||
Loss before provision for income taxes and loss from equity method | (14,168) | (26,814) | (46,087) | (53,425) | ||||
Provision for income taxes | (21) | (253) | (21) | (318) | ||||
Loss from equity method investment | — | — | (1,625) | — | ||||
Net loss | $ (14,189) | $ (27,067) | $ (47,733) | $ (53,743) | ||||
Net loss per share—basic | $ (1.16) | $ (76.39) | $ (5.12) | $ (153.96) | ||||
Net loss per share—diluted | $ (1.16) | $ (76.39) | $ (6.58) | $ (153.96) | ||||
Weighted-average common shares—basic | 12,180,704 | 354,306 | 9,320,884 | 349,060 | ||||
Weighted-average common shares—diluted | 12,180,704 | 354,306 | 9,657,696 | 349,060 | ||||
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SOURCE Q32 Bio
FAQ
What were the key findings from Q32 Bio's (QTTB) bempikibart Phase 2a trial in alopecia areata?
What is QTTB's cash position and financial runway as of Q4 2024?
When will Q32 Bio (QTTB) report topline results for SIGNAL-AA Part B trial?
How did Q32 Bio's (QTTB) Q4 2024 net loss compare to the previous year?
