Kezar Life Sciences Reports Third Quarter 2024 Financial Results and Provides Business Update
Kezar Life Sciences reported Q3 2024 financial results and provided updates on its clinical trials. The company's cash position stood at $148.4 million as of September 30, 2024. The PORTOLA Phase 2a trial for autoimmune hepatitis continues with topline data expected in H1 2025, while the PALIZADE Phase 2b trial for lupus nephritis was terminated following safety concerns. The company reported a net loss of $20.3 million ($2.78 per share) for Q3 2024. R&D expenses decreased to $16.2 million from $23.7 million year-over-year, while G&A expenses reduced to $5.7 million from $8.8 million.
Kezar Life Sciences ha riportato i risultati finanziari per il terzo trimestre del 2024 e fornito aggiornamenti sui suoi trial clinici. La posizione di liquidità dell'azienda si attestava a 148,4 milioni di dollari al 30 settembre 2024. Il trial PORTOLA di fase 2a per l'epatite autoimmune continua, con i dati preliminari attesi nella prima metà del 2025, mentre il trial PALIZADE di fase 2b per la nefrite lupica è stato interrotto a causa di preoccupazioni sulla sicurezza. L'azienda ha riportato una perdita netta di 20,3 milioni di dollari (2,78 dollari per azione) per il terzo trimestre del 2024. Le spese per ricerca e sviluppo sono diminuite a 16,2 milioni di dollari rispetto ai 23,7 milioni dell’anno precedente, mentre le spese generali e amministrative sono scese a 5,7 milioni di dollari rispetto agli 8,8 milioni.
Kezar Life Sciences informó sobre los resultados financieros del tercer trimestre de 2024 y proporcionó actualizaciones sobre sus ensayos clínicos. La posición de efectivo de la empresa era de 148,4 millones de dólares al 30 de septiembre de 2024. El ensayo PORTOLA de fase 2a para la hepatitis autoinmune continúa, con datos preliminares esperados para la primera mitad de 2025, mientras que el ensayo PALIZADE de fase 2b para la nefritis lúpica fue terminado por preocupaciones de seguridad. La compañía reportó una pérdida neta de 20,3 millones de dólares (2,78 dólares por acción) para el tercer trimestre de 2024. Los gastos de I+D disminuyeron a 16,2 millones de dólares de 23,7 millones del año anterior, mientras que los gastos generales y administrativos se redujeron a 5,7 millones de dólares desde 8,8 millones.
Kezar Life Sciences는 2024년 3분기 재무 결과를 보고하고 임상 시험에 대한 업데이트를 제공했습니다. 회사의 현금 보유량은 2024년 9월 30일 기준으로 1억 4840만 달러에 달했습니다. 자가면역 간염에 대한 PORTOLA 2a 시험은 지속 중이며 2025년 상반기에 주요 데이터가 예상됩니다. 반면, 루푸스 신염에 대한 PALIZADE 2b 시험은 안전 문제로 종료되었습니다. 회사는 2024년 3분기에 2030만 달러의 순손실 (주당 2.78달러)을 보고했습니다. 연구 개발 비용은 전년 대비 2천370만 달러에서 1천620만 달러로 감소했으며, 일반 관리 비용은 880만 달러에서 570만 달러로 줄었습니다.
Kezar Life Sciences a annoncé les résultats financiers du troisième trimestre 2024 et a fourni des mises à jour sur ses essais cliniques. La position de trésorerie de l'entreprise s'élevait à 148,4 millions de dollars au 30 septembre 2024. L'essai PORTOLA de phase 2a pour l'hépatite auto-immune se poursuit, avec des données préliminaires attendues au premier semestre 2025, tandis que l'essai PALIZADE de phase 2b pour la néphrite lupique a été interrompu en raison de préoccupations en matière de sécurité. L'entreprise a annoncé une perte nette de 20,3 millions de dollars (2,78 dollars par action) pour le troisième trimestre de 2024. Les dépenses de R&D ont diminué à 16,2 millions de dollars contre 23,7 millions de dollars l'année précédente, tandis que les dépenses administratives et générales ont été réduites à 5,7 millions de dollars contre 8,8 millions de dollars.
Kezar Life Sciences hat die finanziellen Ergebnisse für das 3. Quartal 2024 veröffentlicht und Updates zu seinen klinischen Studien bereitgestellt. Die Liquiditätsposition des Unternehmens betrug zum 30. September 2024 148,4 Millionen Dollar. Die PORTOLA Phase 2a Studie für autoimmune Hepatitis läuft weiter, während die PALIZADE Phase 2b Studie für Lupusnephritis nach Sicherheitsbedenken eingestellt wurde. Das Unternehmen meldete einen Nettoverlust von 20,3 Millionen Dollar (2,78 Dollar pro Aktie) für das 3. Quartal 2024. Die Forschungs- und Entwicklungskosten sanken von 23,7 Millionen Dollar auf 16,2 Millionen Dollar im Jahresvergleich, während die allgemeinen Verwaltungskosten von 8,8 Millionen Dollar auf 5,7 Millionen Dollar reduziert wurden.
- Strong cash position of $148.4 million
- Reduced R&D expenses by $7.5 million year-over-year
- Decreased G&A expenses by $3.1 million year-over-year
- Improved net loss per share from $3.18 to $2.78 year-over-year
- Termination of PALIZADE Phase 2b trial due to safety concerns including fatal events
- FDA placed partial clinical hold on PORTOLA trial's open-label extension
- Net loss of $20.3 million in Q3 2024
- Cash position decreased from $201.4M to $148.4M since December 2023
- Required 1-for-10 reverse stock split to maintain Nasdaq listing compliance
Insights
The Q3 results reveal significant financial challenges.
The termination of the PALIZADE trial and partial clinical hold on PORTOLA create significant uncertainty. With AIH now the primary focus, the company's pipeline has narrowed considerably. At the current burn rate, runway extends approximately 5-6 quarters, potentially requiring additional financing by late 2025.
The safety concerns in the PALIZADE trial, including four Grade 5 (fatal) SAEs, represent a major setback for zetomipzomib's development in lupus nephritis. The pivot to focus solely on autoimmune hepatitis (AIH) significantly reduces the drug's market potential. While the PORTOLA trial continues with IDMC support, the FDA's partial clinical hold limiting the open-label extension and prednisone tapering raises concerns about the drug's long-term safety profile.
- Topline data from PORTOLA Phase 2a clinical trial evaluating zetomipzomib in patients with autoimmune hepatitis (AIH) expected in first half 2025
-
Cash, cash equivalents and marketable securities totaled
as of September 30, 2024$148 million
“The team at Kezar has made great progress towards completing the double-blind portion of the
Zetomipzomib: Selective Immunoproteasome Inhibitor
-
PORTOLA is a placebo-controlled, randomized, double-blind Phase 2a clinical trial evaluating the efficacy and safety of zetomipzomib in patients with AIH that are insufficiently responding to standard of care or have relapsed. The study has completed enrollment of 24 patients, randomized (2:1) to receive 60 mg of zetomipzomib or placebo in addition to background therapy for 24 weeks, with a protocol-suggested steroid taper. The primary efficacy endpoint will measure the proportion of patients who achieve a complete biochemical response by Week 24 measured as normalization of alanine aminotransferase (ALT), aspartate aminotransferase (AST) and Immunoglobulin G (IgG) values (if elevated at baseline), with steroid dose levels not higher than baseline. -
Kezar plans to report topline data in the first half of 2025. In October, the Independent Data Monitoring Committee (IDMC) recommended that the
PORTOLA trial proceed without modification. The IDMC examined safety data from all patients enrolled in the trial, including data from patients who completed the 24-week double-blind treatment period (DBTP) and continued to the open-label extension (OLE) portion of the trial that includes an additional 24 weeks of treatment. To date, no Grade 4 or 5 serious adverse events (SAEs) have been observed in this trial, which is being conducted at clinical trial sites inthe United States . This recommendation occurred following the FDA’s clinical hold on the PALIZADE trial, as described below. -
Following the recommendation made by the IDMC, the FDA notified Kezar that it is allowing enrolled patients to complete the DBTP of the
PORTOLA trial without modification. However, the FDA has placed a partial clinical hold onPORTOLA requiring that the four remaining patients currently in the DBTP should not continue to the OLE portion of the trial. Patients who are currently participating in the OLE may continue treatment on zetomipzomib, but their prednisone dosage may not be tapered below 5 mg/day, and any patients who tapered below this amount will raise their prednisone back to 5 mg/day.
PALIZADE – Phase 2b clinical trial of zetomipzomib in patients with active lupus nephritis (LN) (ClinicalTrials.gov: NCT05781750)
-
In October, Kezar made the strategic decision to terminate the PALIZADE Phase 2b clinical trial in patients with active LN and focus clinical development efforts on zetomipzomib in AIH. PALIZADE was placed on full clinical hold following the recommendation of the PALIZADE IDMC after its assessment of four Grade 5 (fatal) SAEs that occurred in patients enrolled in
the Philippines andArgentina (including one patient on placebo). - Kezar is unblinding the trial and will perform a full investigation into all safety events from the study. 84 patients were enrolled in PALIZADE as of termination, and Kezar expects to report available data from PALIZADE at a later date.
MISSION – Kezar will present results from the open-label Phase 1b/2 MISSION trial in patients with systemic lupus erythematosus (SLE) with or without LN showing zetomipzomib demonstrated improvements in SLE/LN disease measures and biomarkers in patients with highly active SLE or nephrotic range proteinuria at the upcoming American College of Rheumatology (ACR) Convergence 2024, which is taking place November 14 – 19, 2024, in
Business Updates
In October, Kezar effected a one-for-ten reverse stock split of its outstanding shares of common stock (Reverse Stock Split) to regain compliance with the minimum bid price requirement of
Financial Results
-
Cash, cash equivalents and marketable securities totaled
as of September 30, 2024, compared to$148.4 million as of December 31, 2023. The decrease was primarily attributable to cash used in operations to advance clinical-stage programs.$201.4 million -
Research and development (R&D) expenses for the third quarter of 2024 decreased by
to$7.5 million , compared to$16.2 million in the third quarter of 2023. This decrease was primarily due to the Company’s strategic restructuring in October 2023 to prioritize its clinical-stage programs, reducing personnel-related costs and spending in its early-stage research activities. The decrease was partially offset by the increased clinical trial costs related to the PALIZADE and$23.7 million PORTOLA trials. -
General and administrative (G&A) expenses for the third quarter of 2024 decreased by
to$3.1 million compared to$5.7 million in the third quarter of 2023. The decrease was primarily due to a decrease in legal and professional service expenses and non-cash stock-based compensation.$8.8 million -
Net loss for the third quarter of 2024 was
, or$20.3 million per basic and diluted common share, compared to a net loss of$2.78 , or$23.1 million per basic and diluted common share, for the third quarter of 2023. The weighted-average shares used to compute net loss per basic and diluted common share have been retroactively adjusted to reflect the one-for-ten reverse stock split completed on October 29, 2024.$3.18 - Total shares of common stock outstanding were 7.3 million shares as of September 30, 2024, after taking into effect the retroactive application of the one-for-ten reverse stock split completed on October 29, 2024.
About Kezar Life Sciences
Kezar Life Sciences is a clinical-stage biopharmaceutical company developing novel small molecule therapeutics to treat unmet needs in immune-mediated diseases. Zetomipzomib, a selective immunoproteasome inhibitor, is currently being evaluated in a Phase 2a clinical trial for autoimmune hepatitis. This product candidate also has the potential to address multiple chronic immune-mediated diseases. For more information, visit www.kezarlifesciences.com, and follow us on LinkedIn, Facebook, Twitter and Instagram.
Cautionary Note on Forward-looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “can,” “should,” “expect,” “believe,” “potential,” “anticipate” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Kezar’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties that could cause Kezar’s clinical development programs, future results or performance to differ materially from those expressed or implied by the forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about the design, initiation, progress, timing, scope and results of clinical trials, the enrollment and expected timing of reporting topline data from our clinical trials, the likelihood that data will support future development and therapeutic potential, the association of data with treatment outcomes and the likelihood of obtaining regulatory approval of Kezar’s product candidates. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during clinical studies, difficulties enrolling and conducting our clinical trials, changes in expected or existing competition, changes in the regulatory environment, the uncertainties and timing of the regulatory approval process, and unexpected litigation or other disputes. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Kezar’s filings with the
KEZAR LIFE SCIENCES, INC. |
||||||
Selected Balance Sheets Data |
||||||
(In thousands) |
||||||
September 30, 2024 |
December 31, 2023 |
|||||
(unaudited) |
||||||
Cash, cash equivalents and marketable securities |
$ |
148,388 |
$ |
201,372 |
||
Total assets |
|
164,086 |
|
221,235 |
||
Total current liabilities |
|
20,429 |
|
17,744 |
||
Total noncurrent liabilities |
|
9,608 |
|
15,921 |
||
Total stockholders' equity |
|
134,049 |
|
187,570 |
Summary of Operations Data | |||||||||||||||
(In thousands except share and per share data) | |||||||||||||||
Three Months Ended |
|
Nine Months Ended |
|||||||||||||
September 30 |
|
September 30 |
|||||||||||||
2024 |
|
2023 |
|
2024 |
|
2023 |
|||||||||
(unaudited) |
|
(unaudited) |
|||||||||||||
Collaboration revenue |
$ |
- |
|
$ |
7,000 |
|
$ |
- |
|
$ |
7,000 |
|
|||
Operating expenses: |
|||||||||||||||
Research and development |
|
16,242 |
|
|
23,738 |
|
|
49,712 |
|
|
63,055 |
|
|||
General and administrative |
|
5,706 |
|
|
8,789 |
|
|
17,848 |
|
|
20,780 |
|
|||
Impairment charge |
|
- |
|
|
- |
|
|
1,482 |
|
|
- |
|
|||
Total operating expenses |
|
21,948 |
|
|
32,527 |
|
|
69,042 |
|
|
83,835 |
|
|||
Loss from operations |
|
(21,948 |
) |
|
(25,527 |
) |
|
(69,042 |
) |
|
(76,835 |
) |
|||
Interest income |
|
2,038 |
|
|
2,820 |
|
|
6,728 |
|
|
8,376 |
|
|||
Interest expense |
|
(403 |
) |
|
(396 |
) |
|
(1,204 |
) |
|
(1,151 |
) |
|||
Net loss |
$ |
(20,313 |
) |
$ |
(23,103 |
) |
$ |
(63,518 |
) |
$ |
(69,610 |
) |
|||
Net loss per common share, basic and diluted |
$ |
(2.78 |
) |
$ |
(3.18 |
) |
$ |
(8.72 |
) |
$ |
(9.60 |
) |
|||
Weighted-average shares used to compute net loss per common share, basic and diluted (1) |
|
7,296,222 |
|
|
7,268,165 |
|
|
7,286,967 |
|
|
7,249,188 |
|
(1) |
Shares outstanding have been retroactively adjusted to reflect the one-for-ten reverse stock split that completed on October 29, 2024, subject to adjustment due to the issuance of full shares in lieu of fractional shares. |
View source version on businesswire.com: https://www.businesswire.com/news/home/20241112979408/en/
Investor and Media Contact:
Gitanjali Jain
Senior Vice President, Investor Relations and External Affairs
Kezar Life Sciences, Inc.
gjain@kezarbio.com
Source: Kezar Life Sciences, Inc.
FAQ
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