Adenocarcinoma of prostate

AstraZeneca is discontinuing the CAPItello-280 Phase III trial evaluating the efficacy and safety of Truqap (capivasertib) in combination with docetaxel and androgen-deprivation therapy (ADT) compared to docetaxel and ADT with placebo in patients with metastatic castration-resistant prostate cancer (mCRPC). This decision is based on the recommendation of the Independent Data Monitoring Committee (IDMC) following their review of data from a pre-specified interim analysis, which concluded that the Truqap combination was unlikely to meet the dual primary endpoints of radiographic progression-free survival (rPFS) and overall survival (OS) versus the comparator arm upon trial completion. The safety profile for Truqap was consistent with previous trials. The Company will work with investigators to ensure the necessary follow up with patients. Data from the trial will inform ongoing research. Notes Prostate cancer Prostate cancer is the second most prevalent cancer in men and the fifth leading cause of male cancer death globally, with an incidence of more than 1.4 million and over 397,000 deaths in 2022.1 Metastatic prostate cancer is associated with a significant mortality rate, with only one third of patients surviving five years after diagnosis.2 Development of prostate cancer is often driven by male sex hormones called androgens, including testosterone.3 Metastatic castration-resistant prostate cancer Approximately 10-20% of men with advanced prostate cancer will develop castration-resistant prostate cancer within five years.4 In patients with mCRPC, their prostate cancer grows and spreads to other parts of the body despite the use of androgen-deprivation therapy to block the action of male sex hormones.3 At least 84% of these men will have metastases at the time of CRPC diagnosis and, of those patients with no metastases at CRPC diagnosis, 33% are likely to develop metastases within two years.4 Approximately half of patients with mCRPC may receive only one line of active treatment, and those that go on to receive further treatment often have diminishing benefit of subsequent therapies.5-6 Despite the advances in mCRPC treatment with taxane and new hormonal agent treatments, there is high unmet need in this population.4,7,8 CAPItello-280 CAPItello-280 is a Phase III, double-blind, randomised trial evaluating the efficacy and safety of Truqap in combination with docetaxel and ADT compared to docetaxel and ADT in combination with placebo in patients with mCRPC. The global trial enrolled 1,033 adult patients with histologically confirmed prostate adenocarcinoma with evidence of mCRPC with progression of disease despite ADT. The dual primary endpoints of the CAPItello-280 trial are rPFS as assessed by investigator and OS in the overall trial population. Key secondary endpoints include OS and rPFS as assessed by investigator in patients with mCRPC and PTEN-deficient tumours, OS and rPFS as assessed by investigator in patients with mCRPC and PTEN-proficient tumours, time to pain progression (TTPP) in the overall trial population and time to first symptomatic skeletal-related event (SSRE) in the overall trial population. Truqap Truqap is a first-in-class, potent, adenosine triphosphate (ATP)-competitive inhibitor of all three AKT isoforms (AKT1/2/3). Truqap 400mg is administered twice daily according to an intermittent dosing schedule of four days on and three days off. This was chosen in early phase trials based on tolerability and the degree of target inhibition. Truqap in combination with Faslodex (fulvestrant) is approved in the US, EU, Japan, China and several other countries for the treatment of adult patients with HR-positive (or estrogen receptor-positive), HER2-negative locally advanced or metastatic breast cancer with one or more biomarker alterations (PIK3CA, AKT1 or PTEN) following recurrence or progression on or after an endocrine-based regimen based on the results from the CAPItello-291 trial. Truqap is also approved in Australia for the treatment of adult patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer following recurrence or progression on or after an endocrine based regimen based on these trial results. Truqap is being evaluated in ongoing Phase III trials for the treatment of breast and prostate cancers. Truqap was discovered by AstraZeneca subsequent to a collaboration with Astex Therapeutics (and its collaboration with the Institute of Cancer Research and Cancer Research Technology Limited). AstraZeneca in oncology AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients. The Company's focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience. AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death. AstraZeneca AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on social media @AstraZeneca. Contacts For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here References Adrian Kemp Company Secretary AstraZeneca PLC Oncology Corporate and financial

Company continues to explore and review strategic options focused on maximizing shareholder value SOUTH SAN FRANCISCO, California and VANCOUVER, Canada, Feb. 11, 2025 /PRNewswire/ - ESSA Pharma Inc. ("ESSA," or the "Company") (NASDAQ: EPIX), a pharmaceutical company that, prior to the discontinuation of its clinical trials and development programs, has been focused on developing novel therapies for the treatment of prostate cancer, today reported financial results for the fiscal first quarter ended December 31, 2024. "Following our decision to terminate the clinical development of masofaniten, we have been evaluating and reviewing strategic options with a focus on maximizing shareholder value," said David Parkinson, MD, President and CEO of ESSA. "We look forward to providing updates in the near future." First Quarter 2025 and Recent Updates Following the decision to terminate all clinical trials evaluating masofaniten and to withdraw the related IND and CTAs, ESSA is conducting a comprehensive process to explore and review a range of strategic options focused on maximizing shareholder value. These options 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, or other strategic direction. The process is expected to involve headcount and other cost reductions. Summary of Financial Results (Amounts expressed in U.S. dollars) Net Loss. ESSA recorded a net loss of $8.5 million for the first quarter ended December 31, 2024, compared to $6.0 million for the first quarter ended December 31, 2023. Investment and other income was $1.1 million for the first quarter ended December 31, 2024, compared to $1.6 million for the first quarter ended December 31, 2023. Research and Development ("R&D") expenditures. R&D expenditures for the first quarter ended December 31, 2024 were $5.5 million compared to $5.4 million for the first quarter ended December 31, 2023, and include non-cash costs related to share-based payments of $729,780 for the first quarter ended 2024 compared to $526,241 for the first quarter ended 2023. The increase in the first quarter was primarily attributed to the initiation and wind-down of clinical site closures. General and Administration ("G&A") expenditures. G&A expenditures for the first quarter ended December 31, 2024 were $4.2 million compared to $2.2 million for the first quarter ended December 31, 2023 and include non-cash costs related to share-based payments of $1,972,151 for the first quarter ended 2024 compared to $277,177 for the first quarter ended 2023. Liquidity and Outstanding Share Capital As of December 31, 2024, the Company had available cash reserves and short-term investments of $120.6 million and net working capital of $118.8 million. The company has no long-term debt facilities. As of December 31, 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 $0.0001. About ESSA Pharma Inc. ESSA is a 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 . 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 evaluation of its strategic alternatives and future announcements in connection therewith, the Company's expected headcount and cost reductions 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 necessary regulatory approvals; (iii) ESSA's ability to efficiently wind down its clinical trial activities (iv) that one or more strategic options may be available to ESSA 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 17, 2024, under the heading "Risk Factors", a copy of which is available on ESSA's profile on EDGAR at and on SEDAR+ at , 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 United States and Canadian securities laws. Readers are cautioned against attributing undue certainty to forward-looking statements. Contacts ESSA Pharma Inc. David Wood, Chief Financial Officer 778.331.0962 [email protected] Investors and Media Argot Partners 212.600.1902 [email protected] ESSA PHARMA INC. CONSOLIDATED BALANCE SHEETS Unaudited Amounts in thousands of United States dollars ESSA PHARMA INC. CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS Unaudited Amounts in thousands of United States dollars, except share and per share data SOURCE ESSA Pharma Inc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

TUESDAY, Jan. 7, 2025 -- Patients have more access to their own medical test results than ever before, thanks to legislation requiring results be released as soon as they’re available. But that’s not necessarily a good thing, a new study warns. Many patients are reading test results in their electronic medical record before their doctor has had a chance to go over them, researchers say in a study published Jan. 2 in the Journal of the American Medical Association . This is provoking a lot of confusion and anxiety, mainly because medical reports contain a lot of jargon the average patient doesn’t understand, researchers said. For example, “a standard pathology report is written by a pathologist for a clinical specialist like a surgeon or a cancer doctor or for other pathologists to read,” lead researcher Dr. Cathryn Lapedis , a pathologist at University of Michigan Health, said in a news release from the college. To address this, Lapedis and her colleagues tested whether patients might benefit from pathology reports written in a way they would better understand. “A patient-centered pathology report gives important information on the patient’s diagnosis in a clear format that minimizes medical terminology,” Lapedis said. “For example, a standard pathology report will include a term like prostatic adenocarcinoma, but the patient-centered report will simply call it prostate cancer." For the study, researchers recruited more than 2,200 men 55 to 84 with no history of prostate cancer . These men were provided a hypothetical scenario in which they’d been handed test results from a prostate biopsy they underwent due to troubling urinary symptoms. Study participants saw one of three types of reports: standard test forms used by either a civilian hospital or a VA hospital, or a report written to be patient-friendly. From the report, the men were asked to identify their diagnosis, their risk level, and their Gleason score -- a number that reports the aggressiveness of prostate cancer. “We found that most people cannot get basic information -- like whether or not they have prostate cancer -- from standard pathology reports,” Lapedis said. For example, only 39% reading a standard hospital test form could accurately identify that the report showed cancer, results show. On the other hand, 93% of those who got the patient-centered report accurately identified that the report showed prostate cancer. This lack of understanding caused some worry among patients who should have had nothing to fear, researchers added. Patients were more likely to be appropriately worried if they read a patient-friendly report rather than a standard report. In some cases, patients who read a standard report were very worried even though they had little risk, or weren’t appropriately worried about a high-risk diagnosis, results show. “We recommend that hospital systems consider including patient-centered pathology reports with standard reports to improve patient understanding,” Lapedis concluded. The team plans to study the benefits of patient-friendly reports at the University of Michigan. In the meantime, Lapedis advises patients to talk with their doctors about how to read such a test report before even having the test. That way, they’re prepared to look it over in advance. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.