ESSA Pharma Provides Corporate Update and Reports Financial Results for Fiscal Fourth Quarter and Year Ended September 30, 2024
ESSA Pharma (NASDAQ: EPIX) has announced the termination of all clinical trials for masofaniten following disappointing interim analysis results of its Phase 2 combination study with enzalutamide for prostate cancer treatment. The company has initiated a strategic review process to maximize shareholder value, which may include merger, acquisition, or liquidation options.
Financial highlights for fiscal year 2024 include a net loss of $28.5 million, compared to $26.6 million in 2023. R&D expenditures were $21.2 million, while G&A expenses increased to $13.2 million from $10.8 million in 2023. The company maintains a strong financial position with $126.8 million in cash reserves and $124.3 million in net working capital as of September 30, 2024.
ESSA Pharma (NASDAQ: EPIX) ha annunciato la termine di tutti gli studi clinici per masofaniten a seguito di risultati deludenti nell'analisi intermedia del suo studio di fase 2 in combinazione con enzalutamide per il trattamento del cancro alla prostata. L'azienda ha avviato un processo di revisione strategica per massimizzare il valore per gli azionisti, che potrebbe includere opzioni di fusione, acquisizione o liquidazione.
I dati finanziari per l'anno fiscale 2024 includono una perdita netta di 28,5 milioni di dollari, rispetto ai 26,6 milioni di dollari del 2023. Le spese per R&S sono state di 21,2 milioni di dollari, mentre le spese generali e amministrative sono aumentate a 13,2 milioni di dollari rispetto ai 10,8 milioni di dollari del 2023. L'azienda mantiene una forte posizione finanziaria con 126,8 milioni di dollari in riserve liquide e 124,3 milioni di dollari in capitale circolante netto al 30 settembre 2024.
ESSA Pharma (NASDAQ: EPIX) ha anunciado la finalización de todos los ensayos clínicos para masofaniten tras resultados intermedios decepcionantes en su estudio de combinación de fase 2 con enzalutamida para el tratamiento del cáncer de próstata. La empresa ha iniciado un proceso de revisión estratégica para maximizar el valor para los accionistas, que puede incluir opciones de fusión, adquisición o liquidación.
Los aspectos financieros del año fiscal 2024 incluyen una pérdida neta de 28,5 millones de dólares, en comparación con los 26,6 millones de dólares en 2023. Los gastos en I+D fueron de 21,2 millones de dólares, mientras que los gastos generales y administrativos aumentaron a 13,2 millones de dólares desde 10,8 millones de dólares en 2023. La empresa mantiene una fuerte posición financiera con 126,8 millones de dólares en reservas de efectivo y 124,3 millones de dólares en capital de trabajo neto a partir del 30 de septiembre de 2024.
ESSA Pharma (NASDAQ: EPIX)는 전립선 암 치료를 위한 엔잘루타미드와의 2상 병용 연구에서 실망스러운 중간 분석 결과에 따라 마소파니텐의 모든 임상 시험을 종료한다고 발표했습니다. 회사는 합병, 인수 또는 청산 옵션을 포함할 수 있는 주주 가치를 극대화하기 위한 전략적 검토 프로세스를 시작했습니다.
2024 회계 연도의 재무 하이라이트에는 2850만 달러의 순손실이 포함되며, 이는 2023년의 2660만 달러와 비교됩니다. 연구 및 개발 비용은 2120만 달러였으며, 일반 관리비는 2023년의 1080만 달러에서 1320만 달러로 증가했습니다. 회사는 2024년 9월 30일 기준으로 1억 2680만 달러의 현금 보유액과 1억 2430만 달러의 순 운전 자본을 보유하고 있어 강력한 재무 상태를 유지하고 있습니다.
ESSA Pharma (NASDAQ: EPIX) a annoncé la cessation de tous les essais cliniques pour masofaniten à la suite de résultats d'analyse intermédiaire décevants de son étude de phase 2 sur la combinaison avec l'enzalutamide pour le traitement du cancer de la prostate. L'entreprise a lancé un processus d'examen stratégique pour maximiser la valeur pour les actionnaires, qui pourrait inclure des options de fusion, d'acquisition ou de liquidation.
Les points saillants financiers de l'exercice 2024 comprennent une perte nette de 28,5 millions de dollars, contre 26,6 millions de dollars en 2023. Les dépenses de R&D s'élevaient à 21,2 millions de dollars, tandis que les frais généraux et administratifs ont augmenté à 13,2 millions de dollars contre 10,8 millions de dollars en 2023. L'entreprise maintient une solide position financière avec 126,8 millions de dollars de réserves de liquidités et 124,3 millions de dollars de fonds de roulement net au 30 septembre 2024.
ESSA Pharma (NASDAQ: EPIX) hat die Beendigung aller klinischen Studien zu Masofaniten angekündigt, nachdem die vorläufigen Analyseergebnisse seiner Phase-2-Kombinationsstudie mit Enzalutamid zur Behandlung von Prostatakrebs enttäuschend waren. Das Unternehmen hat einen strategischen Überprüfungsprozess eingeleitet, um den Shareholder-Value zu maximieren, der Fusionen, Übernahmen oder Liquidationsoptionen umfassen kann.
Finanzielle Highlights für das Geschäftsjahr 2024 umfassen einen Nettoverlust von 28,5 Millionen Dollar, verglichen mit 26,6 Millionen Dollar im Jahr 2023. Die F&E-Ausgaben betrugen 21,2 Millionen Dollar, während die allgemeinen Verwaltungskosten von 10,8 Millionen Dollar im Jahr 2023 auf 13,2 Millionen Dollar gestiegen sind. Das Unternehmen bleibt mit 126,8 Millionen Dollar an Zahlungsmitteln und 124,3 Millionen Dollar an Nettoumlaufvermögen zum 30. September 2024 in einer starken finanziellen Position.
- Strong cash position of $126.8 million and net working capital of $124.3 million
- No long-term debt obligations
- Termination of all clinical trials for masofaniten due to failure to meet primary endpoint
- Net loss increased to $28.5 million from $26.6 million year-over-year
- G&A expenses increased to $13.2 million from $10.8 million year-over-year
- Planned headcount and cost reductions
Insights
Company has initiated a process to explore and review strategic options focused on maximizing shareholder value
"We recently made the difficult decision to terminate the clinical development of masofaniten, and withdraw the related IND and CTAs, based on an interim analysis of the data from the Phase 2 combination study, concluding that masofaniten combined with enzalutamide was unlikely to meet its primary endpoint," said David Parkinson, MD, President and CEO of ESSA. "We are currently evaluating and reviewing our strategic options focused on maximizing shareholder value and look forward to providing further updates in the near future."
Fourth Quarter Fiscal 2024 and Recent Updates
- In October 2024, ESSA made the decision to terminate all clinical trials evaluating masofaniten and to withdraw the related IND and CTAs. The decision was based on the outcome of a futility analysis conducted as part of a protocol-specified interim review of the Phase 2 clinical trial evaluating masofaniten combined with enzalutamide versus enzalutamide monotherapy in patients with metastatic castration-resistant prostate cancer ("mCRPC") naïve to second-generation antiandrogens.
- The interim analysis, which reviewed the Phase 2 safety, PK and efficacy data, showed that the study enzalutamide monotherapy control arm (which is the standard of care for this patient population) had a much higher rate of PSA90 response than was expected based upon historical data. In addition, there was no clear efficacy benefit seen with the combination of masofaniten plus enzalutamide compared to enzalutamide single agent. A futility analysis determined a low likelihood of meeting the prespecified primary endpoint of the study. It was therefore concluded that the study was unlikely to achieve its primary endpoint.
- The combination of masofaniten plus enzalutamide was well-tolerated with no new safety signals and a safety profile similar to that seen in Phase 1 monotherapy and combination studies.
- The interim analysis, which reviewed the Phase 2 safety, PK and efficacy data, showed that the study enzalutamide monotherapy control arm (which is the standard of care for this patient population) had a much higher rate of PSA90 response than was expected based upon historical data. In addition, there was no clear efficacy benefit seen with the combination of masofaniten plus enzalutamide compared to enzalutamide single agent. A futility analysis determined a low likelihood of meeting the prespecified primary endpoint of the study. It was therefore concluded that the study was unlikely to achieve its primary endpoint.
- ESSA has initiated a comprehensive process to explore and review a range of strategic options focused on maximizing shareholder value, which may include, but are not limited to a merger, amalgamation, take-over, business combination, asset sale or acquisition, shareholder distribution, wind-up, liquidation and dissolution, seek new products for development, or other strategic direction. The process is expected to involve headcount and other cost reductions.
- On December 12, 2024, ESSA provided a notice of termination of the License Agreement to the Licensors, notifying the Licensors that it terminated the License Agreement in accordance with its terms, effective as of December 12, 2024.
Summary Financial Results
(Amounts expressed in
- Net Loss. ESSA recorded a net loss of
$28.5 million $26.6 million $6.5 million $5.3 million $6.4 million $5.5 million - Research and Development ("R&D") expenditures. R&D expenditures for the year ended September 30, 2024 were
$21.2 million $21.3 million $1.8 million $2.7 million $4.2 million $5.2 million - General and Administration ("G&A") expenditures. G&A expenditures for the year ended September 30, 2024 were
$13.2 million $10.8 million $4.7 million $2.6 million $3.5 million $1.9 million
Liquidity and Outstanding Share Capital
- As of September 30, 2024, the Company had available cash reserves and short-term investments of
$126.8 million $124.3 million - As of September 30, 2024, the Company had 44,388,550 common shares issued and outstanding, and there were 2,920,000 common shares issuable upon the exercise of prefunded warrants at an exercise price of
$0.00 01
About ESSA Pharma Inc.
ESSA is a clinical-stage pharmaceutical company that was previously focused on developing novel and proprietary therapies for the treatment of patients with prostate cancer. For more information, please visit www.essapharma.com.
Forward-Looking Statement Disclaimer
This release contains certain information which, as presented, constitutes "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and "forward-looking information" within the meaning of applicable Canadian securities laws (collectively, "forward-looking statements"). Forward-looking statements include, but are not limited to, statements that relate to future events and often addresses expected future business and financial performance, containing words such as "anticipate", "believe", "plan", "estimate", "expect", and "intend", statements that an action or event "may", "might", "could", "should", or "will" be taken or occur, or other similar expressions and includes, but is not limited to, statements regarding the termination of the Company's clinical studies of masofaniten, the Company's financial resources, the evaluation of the Company's strategic alternatives, the primary and PSA-related endpoints of the Phase 2 study and other statements surrounding the Company's evaluation of masofaniten.
Forward-looking statements are subject to various known and unknown risks and uncertainties, many of which are beyond the ability of ESSA to control or predict, and which may cause ESSA's actual results, performance or achievements to be materially different from those expressed or implied thereby. Such statements reflect ESSA's current views with respect to future events, are subject to risks and uncertainties and are necessarily based upon a number of estimates and assumptions that, while considered reasonable by ESSA as of the date of such statements, are inherently subject to significant medical, scientific, business, economic, competitive, political and social uncertainties and contingencies. In making forward looking statements, ESSA may make various material assumptions, including but not limited to (i) the accuracy of ESSA's financial projections; (ii) obtaining positive results of clinical trials; (iii) obtaining necessary regulatory approvals; (iv) that one or more strategic options may be available to the Company at reasonably acceptable terms; and (v) general business, market and economic conditions.
Forward-looking statements are developed based on assumptions about such risks, uncertainties and other factors set out herein and in ESSA's Annual Report on Form 10-K dated December [10], 2024, under the heading "Risk Factors", a copy of which is available on ESSA's profile on EDGAR at www.sec.gov and on SEDAR+ at www.sedarplus.ca, and as otherwise disclosed from time to time on ESSA's EDGAR and SEDAR+ profiles. Forward-looking statements are made based on management's beliefs, estimates and opinions on the date that statements are made and ESSA undertakes no obligation to update forward-looking statements if these beliefs, estimates and opinions or other circumstances should change, except as may be required by applicable
Contacts
ESSA Pharma Inc.
David Wood, Chief Financial Officer
778.331.0962
dwood@essapharma.com
Investors and Media
Argot Partners
212.600.1902
essa@argotpartners.com
ESSA PHARMA INC.
CONSOLIDATED BALANCE SHEETS
Amounts in thousands of
September 30, | September 30, | |
Cash | $ 103,710 | $ 33,702 |
Prepaids and other assets | 24,402 | 115,420 |
Total assets | $ 128,112 | $ 149,122 |
Current liabilities | 3,301 | 3,495 |
Long-term lease liability | 205 | - |
Shareholders' deficiency | 124,606 | 145,627 |
Total liabilities and shareholders' equity | $ 128,112 | $ 149,122 |
ESSA PHARMA INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
Amounts in thousands of
Three months September 30, | Three months September 30, | Year ended September 30, | Year ended September 30, | ||||
OPERATING EXPENSES | |||||||
Research and development | $ 4,188 | $ 5,226 | $ 21,207 | $ 21,323 | |||
Financing costs | - | 1 | - | 7 | |||
General and administration | 3,507 | 1,922 | 13,214 | 10,812 | |||
Total operating expenses | (7,695) | (7,149) | (34,421) | (32,142) | |||
Interest and other items | 1,339 | 1,668 | 5,878 | 5,560 | |||
Net loss before taxes | (6,356) | (5,481) | (28,543) | (26,582) | |||
Income tax expense (recovery) | — | — | - | (2) | |||
Net loss for the period | $ (6,356) | $ (5,483) | $ (28,543) | $ (26,584) | |||
OTHER COMPREHENSIVE LOSS | |||||||
Unrealized gain (loss) on short- | 37 | 2 | 57 | 15 | |||
Loss and comprehensive loss for | $ (6,319) | $ (5,479) | $ (28,486) | $ (26,569) | |||
Basic and diluted loss per | $ (0.14) | $ (0.12) | $ (0.64) | $ (0.60) | |||
Weighted average number of common shares outstanding | 44,366,126 | 44,092,374 | 44,277,050 | 44,089,557 | |||
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SOURCE ESSA Pharma Inc
FAQ
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