Zura Bio Reports Third Quarter 2024 Financial Results and Recent Corporate Updates
Zura Bio (NASDAQ: ZURA) reported Q3 2024 financial results with a net loss of $22.9 million ($0.26 per share), compared to $8.3 million ($0.18 per share) in Q3 2023. The company maintains a strong cash position of $188.2 million, expected to fund operations through 2027. Research and development expenses increased to $6.0 million, while general and administrative expenses rose to $13.3 million.
The company plans to initiate Phase 2 trials for tibulizumab in systemic sclerosis (Q4 2024) and hidradenitis suppurativa (Q2 2025). An Orphan Drug Designation application was submitted to the FDA for systemic sclerosis treatment.
Zura Bio (NASDAQ: ZURA) ha riportato i risultati finanziari del Q3 2024, registrando una perdita netta di 22,9 milioni di dollari (0,26 dollari per azione), rispetto agli 8,3 milioni di dollari (0,18 dollari per azione) nel Q3 2023. L'azienda mantiene una solida posizione di liquidità di 188,2 milioni di dollari, previsto per finanziare le operazioni fino al 2027. Le spese per ricerca e sviluppo sono aumentate a 6,0 milioni di dollari, mentre le spese generali e amministrative sono salite a 13,3 milioni di dollari.
L'azienda prevede di avviare i trial di Fase 2 per il tibulizumab nella sclerosi sistemica (Q4 2024) e nella hidradenite suppurativa (Q2 2025). È stata presentata una domanda di designazione di farmaco orfano all'FDA per il trattamento della sclerosi sistemica.
Zura Bio (NASDAQ: ZURA) reportó los resultados financieros del tercer trimestre de 2024, con una pérdida neta de 22.9 millones de dólares (0.26 dólares por acción), en comparación con los 8.3 millones de dólares (0.18 dólares por acción) en el tercer trimestre de 2023. La compañía mantiene una sólida posición de efectivo de 188.2 millones de dólares, que se espera financie las operaciones hasta 2027. Los gastos de investigación y desarrollo aumentaron a 6.0 millones de dólares, mientras que los gastos generales y administrativos subieron a 13.3 millones de dólares.
La empresa planea iniciar ensayos de Fase 2 para el tibulizumab en esclerosis sistémica (Q4 2024) y en hidradenitis supurativa (Q2 2025). Se presentó una solicitud de designación de medicamento huérfano a la FDA para el tratamiento de la esclerosis sistémica.
주라 바이오 (NASDAQ: ZURA)는 2024년 3분기 재무 결과를 발표하며 2,290만 달러(주당 0.26 달러)의 순손실을 기록했다고 전했습니다. 이는 2023년 3분기 830만 달러(주당 0.18 달러)에 비해 증가한 수치입니다. 이 회사는 2027년까지 운영 자금을 지원할 것으로 예상되는 1억 8820만 달러의 강력한 현금 포지션을 유지하고 있습니다. 연구 및 개발 비용은 600만 달러로 증가했으며, 일반 및 관리 비용은 1,330만 달러로 늘어났습니다.
회사는 2상 시험을 진행할 계획이며, 이는 전신 경화증(2024년 4분기)과 한선염(2025년 2분기)에 대한 것입니다. 전신 경화증 치료를 위해 FDA에 희귀 의약품 지정 신청서를 제출했습니다.
Zura Bio (NASDAQ: ZURA) a annoncé les résultats financiers du troisième trimestre 2024, affichant une perte nette de 22,9 millions de dollars (0,26 dollar par action), contre 8,3 millions de dollars (0,18 dollar par action) au troisième trimestre 2023. L'entreprise maintient une position de liquidité solide de 188,2 millions de dollars, qui devrait financer ses opérations jusqu'en 2027. Les dépenses de recherche et développement ont augmenté à 6,0 millions de dollars, tandis que les dépenses générales et administratives ont atteint 13,3 millions de dollars.
La société prévoit de lancer des essais de Phase 2 pour le tibulizumab dans la sclérose systémique (Q4 2024) et l'hidradenite suppurativa (Q2 2025). Une demande de désignation de médicament orphelin a été soumise à la FDA pour le traitement de la sclérose systémique.
Zura Bio (NASDAQ: ZURA) hat die finanziellen Ergebnisse für das dritte Quartal 2024 veröffentlicht und verzeichnete einen Nettoverlust von 22,9 Millionen US-Dollar (0,26 US-Dollar pro Aktie), im Vergleich zu 8,3 Millionen US-Dollar (0,18 US-Dollar pro Aktie) im dritten Quartal 2023. Das Unternehmen hat eine starke Liquiditätsposition von 188,2 Millionen US-Dollar, die voraussichtlich die Betriebskosten bis 2027 decken wird. Die Forschungsausgaben stiegen auf 6,0 Millionen US-Dollar, während die allgemeinen und administrativen Ausgaben auf 13,3 Millionen US-Dollar anstiegen.
Das Unternehmen plant, Phase-2-Studien für Tibulizumab bei systemischer Sklerose (Q4 2024) und Hidradenitis suppurativa (Q2 2025) zu beginnen. Ein Antrag auf Orphan-Drug-Designation wurde bei der FDA zur Behandlung der systemischen Sklerose eingereicht.
- Strong cash position of $188.2 million, sufficient to fund operations through 2027
- Successful completion of warrant exchange program, simplifying capital structure
- Establishment of ATM program providing increased financial flexibility
- Net loss increased to $22.9 million in Q3 2024 from $8.3 million in Q3 2023
- R&D expenses increased by $2.0 million year-over-year
- G&A expenses rose significantly by $7.1 million compared to previous year
Insights
The Q3 results reveal a concerning financial trajectory with net losses widening to
Operating expenses show significant growth, with R&D costs up
The advancement of tibulizumab into Phase 2 trials for both systemic sclerosis and hidradenitis suppurativa represents strategic positioning in underserved markets. The orphan drug designation pursuit for SSc could provide significant market advantages. The company's multi-asset approach, including monitoring competitors' progress in IL-7Rα and IL-33/ST2 pathways, demonstrates a comprehensive immunology pipeline strategy.
The planned trial initiations in Q4 2024 for SSc and Q2 2025 for HS align with industry timelines, though success will depend heavily on trial outcomes given the challenging nature of these indications.
- Expect to initiate Phase 2 studies evaluating tibulizumab for the treatment of systemic sclerosis (SSc) in Q4 2024 and hidradenitis suppurativa (HS) in Q2 2025
-
Cash, cash equivalents and investments totaling
$188.2 million
"In the third quarter of 2024, we made significant progress toward initiating our first Phase 2 trial of tibulizumab in SSc. We’ve worked closely with our contract research organization (CRO) to begin trial readiness and prepare for site activation," said Robert Lisicki, CEO of Zura Bio. “Additionally, we've selected a CRO to support the anticipated Phase 2 trial initiation for tibulizumab in HS in the second quarter of 2025. We're excited to advance toward these milestones and highlight tibulizumab's potential as a best-in-class therapy for these underserved diseases."
RECENT UPDATES AND UPCOMING ANTICIPATED MILESTONES:
Tibulizumab
Systemic sclerosis
- In September 2024, the protocol for the Phase 2 clinical program in systemic sclerosis was finalized.
-
The Orphan Drug Designation application was completed, and the request was submitted to the
U.S. Food and Drug Administration (FDA) in Q4 2024. - The Phase 2 clinical trial of tibulizumab for the treatment of SSc is anticipated to initiate in Q4 2024.
Hidradenitis suppurativa
- In September 2024, a third-party CRO was selected to oversee and conduct the Phase 2 clinical program in HS.
- The Pre-IND meeting request was submitted in Q4 2024 and the IND submission to the FDA for a Phase 2 trial of tibulizumab in HS is expected in Q1 2025.
- The Phase 2 trial of tibulizumab for the treatment of HS is anticipated to initiate in Q2 2025.
Crebankitug
- Ongoing monitoring of external Phase 2 data releases from other companies relating to IL-7Rα inhibitors in development for conditions such as ulcerative colitis, atopic dermatitis and alopecia areata.
Torudokimab
- Ongoing monitoring of external Phase 2 and Phase 3 IL-33/ST2 data releases from other companies related to asthma and chronic obstructive pulmonary disease.
Corporate Highlights
- In August 2024, the company successfully completed a warrant exchange program, simplifying its capital structure.
- As of September 2024, an “at-the-market” (ATM) program is in place, providing the company with increased financial flexibility.
THIRD QUARTER 2024 FINANCIAL RESULTS:
Cash and Cash Equivalents
Cash and cash equivalents were
Operating Results
Research and development expenses were
General and Administrative expenses were
Net Loss
Net loss for the third quarter of 2024 was
ABOUT ZURA BIO
Zura Bio is a clinical-stage, multi-asset immunology company developing novel dual-pathway antibodies for autoimmune and inflammatory diseases. Currently, Zura Bio is developing three assets which have completed Phase 1/1b studies. The company is developing a portfolio of therapeutic indications for tibulizumab (ZB-106), crebankitug (ZB-168), and torudokimab (ZB-880), with a goal of demonstrating their efficacy, safety, and dosing convenience in autoimmune and inflammatory diseases, including systemic sclerosis and other novel indications with unmet needs.
FORWARD-LOOKING STATEMENTS
This communication includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Words such as “expect,” “estimate,” “project,” “budget,” “forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,” “believe,” “predict,” “potential,” “continue,” “strategy,” “future,” “opportunity,” “would,” “seem,” “seek,” “outlook,” “goal,” “mission,” and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties that could cause the actual results to differ materially from the expected results. These statements are based on various assumptions, whether or not identified in this communication. These forward-looking statements in this release include, but are not limited to, statements regarding: Zura Bio’s forecasts, including with respect to its cash resources, and Zura Bio’s expectations regarding funding, operating and working capital expenditures, business strategies and objectives; expectations with respect to data readouts and the timing thereof; Zura Bio’s product candidates, clinical trials and the design and timing thereof, statements with respect to the potential of product candidates; and expectations with respect to Zura Bio’s development program, including regulatory matters, clinical trials and the timing thereof, and expectations with respect to development programs, data readouts and product candidates of other parties. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability.
Actual events are difficult or impossible to predict and could differ materially from those expressed or implied in such forward-looking statements, as a result of these risks and uncertainties, which include, but are not limited to: Zura Bio’s expectations regarding its product candidates and their related benefits, and Zura Bio’s beliefs regarding competing product candidates and products both in development and approved, may not be achieved; Zura Bio's vision and strategy may not be successful; the timing of key events and initiation of Zura Bio's studies, regulatory matters and release of clinical data may take longer than anticipated or may not be achieved at all; the potential general acceptability and maintenance of Zura Bio's product candidates by regulatory authorities, payors, physicians, and patients may not be achieved; Zura Bio's ability to attract and retain key personnel; Zura Bio's expectations with respect to its future operating expenses, capital requirements and needs for additional financing may not be achieved; Zura Bio has not completed any clinical trials, and has no products approved for commercial sale; Zura Bio has incurred significant losses since inception, and expects to incur significant losses for the foreseeable future and may not be able to achieve or sustain profitability in the future; Zura Bio requires substantial additional capital to finance its operations, and if it is unable to raise such capital when needed or on acceptable terms, Zura Bio may be forced to delay, reduce, and/or eliminate one or more of its development programs or future commercialization efforts; Zura Bio may be unable to renew existing contracts or enter into new contracts; Zura Bio relies on third-party contract development manufacturing organizations for the manufacture of clinical materials; Zura Bio relies on contract research organizations, clinical trial sites, and other third parties to conduct of its preclinical studies and clinical trials; Zura Bio may be unable to obtain regulatory approval for its product candidates, and there may be related restrictions or limitations of any approved products; Zura Bio may be unable to successfully respond to general economic and geopolitical conditions; Zura Bio may be unable to effectively manage growth; Zura Bio faces competitive pressures from other companies worldwide; Zura Bio may be unable to adequately protect its intellectual property rights; and other factors set forth in documents filed, or to be filed by Zura Bio, with the Securities and Exchange Commission (SEC), including the risks and uncertainties described in the “Risk Factors” section of Zura Bio's Annual Report on Form 10-K for the year ended December 31, 2023 and other filings with the SEC. These risks and uncertainties may be amplified by health epidemics or other unanticipated global disruption events, which may continue to cause economic uncertainty. Zura Bio cautions that the foregoing list of factors is not exclusive or exhaustive and not to place undue reliance upon any forward-looking statements, which speak only as of the date made. Zura Bio gives no assurance that it will achieve its expectations. Zura Bio does not undertake or accept any obligation to update any forward-looking statements, except as required by law.
ZURA BIO LIMITED CONSOLIDATED BALANCE SHEETS (In thousands, except share data) |
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September 30, |
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December 31, |
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2024 |
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2023 |
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(unaudited) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
188,221 |
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$ |
99,806 |
|
Prepaid expenses and other current assets |
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|
754 |
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|
|
1,037 |
|
Total current assets |
|
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188,975 |
|
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100,843 |
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Property and equipment, net |
|
|
44 |
|
|
|
— |
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Other assets |
|
|
52 |
|
|
|
— |
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Total assets |
|
$ |
189,071 |
|
|
$ |
100,843 |
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Liabilities, Redeemable Noncontrolling Interest and Shareholders’ Equity |
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Current liabilities: |
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Accounts payable and accrued expenses |
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$ |
18,244 |
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$ |
20,302 |
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Total current liabilities |
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18,244 |
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20,302 |
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Private placement warrants |
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- |
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990 |
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Total liabilities |
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18,244 |
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21,292 |
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Commitments and contingencies |
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Redeemable noncontrolling interest |
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16,240 |
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|
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18,680 |
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Shareholders’ Equity: |
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Preferred shares, |
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— |
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|
|
— |
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Class A Ordinary Shares, |
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|
7 |
|
|
|
4 |
|
Additional paid-in capital |
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295,311 |
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162,820 |
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Accumulated deficit |
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|
(142,272 |
) |
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|
(103,494 |
) |
Total Zura Bio Limited shareholders’ equity |
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153,046 |
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|
|
59,330 |
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Noncontrolling interest |
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1,541 |
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|
|
1,541 |
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Total shareholders’ equity |
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154,587 |
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|
|
60,871 |
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Total liabilities, redeemable noncontrolling interest and shareholders’ equity |
|
$ |
189,071 |
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|
$ |
100,843 |
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ZURA BIO LIMITED CONSOLIDATED STATEMENTS OF OPERATIONS (In thousands, except share and per share data) unaudited |
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For the Three Months Ended |
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September 30, |
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2024 |
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2023 |
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Operating expenses: |
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Research and development |
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$ |
6,029 |
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$ |
3,965 |
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General and administrative |
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13,290 |
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6,222 |
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Total operating expenses |
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19,319 |
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10,187 |
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Loss from operations |
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(19,319 |
) |
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(10,187 |
) |
Other (income)/expense, net: |
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Other (income)/expense, net |
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(22 |
) |
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4 |
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Interest income |
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(2,461 |
) |
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(815 |
) |
Dividend income |
|
|
— |
|
|
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(987 |
) |
Change in fair value of private placement warrants |
|
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3,866 |
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|
|
(119 |
) |
Change in fair value of note payable |
|
|
— |
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|
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— |
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Total other (income)/expense, net |
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1,383 |
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|
|
(1,917 |
) |
Loss before income taxes |
|
|
(20,702 |
) |
|
|
(8,270 |
) |
Income tax benefit |
|
|
— |
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— |
|
Net loss before redeemable noncontrolling interest |
|
|
(20,702 |
) |
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|
(8,270 |
) |
Net loss attributable to redeemable noncontrolling interest |
|
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— |
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|
|
— |
|
Net loss |
|
|
(20,702 |
) |
|
|
(8,270 |
) |
Accretion of redeemable noncontrolling interest to redemption value |
|
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(2,240 |
) |
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— |
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Net loss attributable to Class A Ordinary Shareholders of Zura |
|
$ |
(22,942 |
) |
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$ |
(8,270 |
) |
Net loss per share attributable to Class A Ordinary Shareholders of Zura, basic and diluted |
|
$ |
(0.26 |
) |
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$ |
(0.18 |
) |
Weighted-average Class A Ordinary Shares used in computing net loss per share attributable to Class A Ordinary Shareholders of Zura, basic and diluted |
|
|
87,335,667 |
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46,876,344 |
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View source version on businesswire.com: https://www.businesswire.com/news/home/20241107568043/en/
Megan K. Weinshank
Head of Corporate Affairs
ir@zurabio.com
Source: Zura Bio Limited
FAQ
What was Zura Bio's (ZURA) net loss per share in Q3 2024?
When will Zura Bio (ZURA) initiate Phase 2 trials for tibulizumab in systemic sclerosis?
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What were Zura Bio's (ZURA) R&D expenses in Q3 2024?
