UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ESSA Pharma Inc. (Exact name of registrant as specified in its charter) British Columbia, Canada 98-1250703 (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification Number) Suite 720, 999 West Broadway Vancouver, BC V5Z 1K5 (Address of principal executive offices, including zip code) Registrant's telephone number, including area code: (778) 331-0962 (Mark One) ☒ ANNUAL REPORT PURSUANT TO S ...

[Cautionary Note Regarding Forward-Looking Statements](index=3&type=section&id=CAUTIONARY%20NOTE%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) This section outlines forward-looking statements about the Company's plans, objectives, and future financial performance - The report includes forward-looking statements concerning the Company's plans, objectives, goals, strategies, future events, revenue, performance, capital expenditures, and financing needs. These statements are subject to known and unknown risks and uncertainties that could cause actual results to differ materially[7](index=7&type=chunk)[10](index=10&type=chunk)[11](index=11&type=chunk) - Key forward-looking statements relate to maintaining operations amidst macroeconomic factors (inflation, supply chain, COVID-19), advancing product candidates through clinical trials, patient recruitment, collaborations, funding, intellectual property protection, achieving profitability, and regulatory approvals[7](index=7&type=chunk)[14](index=14&type=chunk)[15](index=15&type=chunk) [Risk Factor Summary](index=5&type=section&id=RISK%20FACTOR%20SUMMARY) This section summarizes key investment risks, including macroeconomic factors, clinical trial uncertainties, and single product reliance - An investment in ESSA Pharma Inc. Common Shares is speculative and risky, with material factors including global macroeconomic risks (inflation, supply chain, COVID-19), clinical trial development uncertainties, reliance on third-party collaborations, and dependence on a single product candidate[13](index=13&type=chunk)[17](index=17&type=chunk) - Other significant risks involve obtaining regulatory approvals, successful commercialization, potential undesirable side effects of product candidates, ability to enroll subjects in trials, manufacturing limitations, foreign operations risks, and disruptions in supply chains[17](index=17&type=chunk) - Financial risks include uncertainty in raising additional funding, potential dilution from financing, significant historical and anticipated losses, limited operating history, and risks related to intellectual property protection and potential infringement claims[17](index=17&type=chunk)[18](index=18&type=chunk)[21](index=21&type=chunk) [PART I. FINANCIAL INFORMATION](index=12&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements and Supplementary Data](index=12&type=section&id=Item%201.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents ESSA Pharma Inc.'s unaudited interim financial statements for Q2 and 9 months ended June 30, 2023, with detailed notes [Condensed Consolidated Interim Balance Sheets](index=13&type=section&id=Condensed%20Consolidated%20Interim%20Balance%20Sheets) The balance sheets reflect a decrease in cash and total assets, partially offset by an increase in short-term investments - The Company's cash and cash equivalents decreased from **$57.1 million** to **$38.5 million**, while short-term investments increased from **$110.2 million** to **$114.0 million** between September 30, 2022, and June 30, 2023[28](index=28&type=chunk) - Total assets declined from **$169.5 million** to **$153.7 million**, and total shareholders' equity decreased from **$167.1 million** to **$150.2 million** over the nine-month period[28](index=28&type=chunk) ASSETS | ASSETS | | | :--- | :--- | | **Current Assets** | | | Cash and cash equivalents (June 30, 2023) | $38,466,991 | | Cash and cash equivalents (September 30, 2022) | $57,076,475 | | Short-term investments (June 30, 2023) | $114,001,923 | | Short-term investments (September 30, 2022) | $110,161,029 | | Total current assets (June 30, 2023) | $153,290,379 | | Total current assets (September 30, 2022) | $169,059,341 | | **Total Assets** | | | Total assets (June 30, 2023) | $153,650,198 | | Total assets (September 30, 2022) | $169,505,295 | | **LIABILITIES AND SHAREHOLDERS' EQUITY** | | | **Current Liabilities** | | | Accounts payable and accrued liabilities (June 30, 2023) | $3,296,377 | | Accounts payable and accrued liabilities (September 30, 2022) | $2,176,565 | | Total current liabilities (June 30, 2023) | $3,407,650 | | Total current liabilities (September 30, 2022) | $2,310,399 | | **Total Liabilities** | | | Total liabilities (June 30, 2023) | $3,407,650 | | Total liabilities (September 30, 2022) | $2,386,817 | | **Shareholders' Equity** | | | Total shareholders' equity (June 30, 2023) | $150,242,548 | | Total shareholders' equity (September 30, 2022) | $167,118,478 | [Condensed Consolidated Interim Statements of Operations and Comprehensive Loss](index=15&type=section&id=Condensed%20Consolidated%20Interim%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The statements show a reduced net loss for the nine months ended June 30, 2023, primarily due to lower operating expenses - For the nine months ended June 30, 2023, the net loss decreased to **$21.1 million** from **$28.8 million** in the prior year, primarily due to reduced research and development expenses[30](index=30&type=chunk) - Basic and diluted loss per common share improved to **$(0.48)** for the nine months ended June 30, 2023, compared to **$(0.65)** for the same period in 2022[30](index=30&type=chunk) OPERATING EXPENSES | OPERATING EXPENSES | | | | :--- | :--- | :--- | | **For the three months ended June 30, 2023 vs 2022** | | | | Research and development | $6,271,186 (2023) | $6,394,534 (2022) | | General and administration | $2,639,381 (2023) | $2,895,542 (2022) | | Total operating expenses | $(8,912,094) (2023) | $(9,293,221) (2022) | | Net loss for the period | $(7,298,873) (2023) | $(8,826,743) (2022) | | Basic and diluted loss per common share | $(0.17) (2023) | $(0.20) (2022) | | **For the nine months ended June 30, 2023 vs 2022** | | | | Research and development | $16,096,299 (2023) | $20,063,752 (2022) | | General and administration | $8,889,192 (2023) | $9,775,082 (2022) | | Total operating expenses | $(24,991,312) (2023) | $(29,849,830) (2022) | | Net loss for the period | $(21,100,994) (2023) | $(28,779,266) (2022) | | Basic and diluted loss per common share | $(0.48) (2023) | $(0.65) (2022) | [Condensed Consolidated Interim Statements of Cash Flows](index=16&type=section&id=Condensed%20Consolidated%20Interim%20Statements%20of%20Cash%20Flows) Cash flow statements show decreased operating cash use, but overall cash and equivalents declined due to investing activities - Net cash used in operating activities decreased to **$15.3 million** for the nine months ended June 30, 2023, from **$20.5 million** in the prior year, reflecting a lower net loss[31](index=31&type=chunk) - Cash and cash equivalents at the end of the period were **$38.5 million**, a decrease from **$67.9 million** in the same period last year, primarily due to cash used in operating and investing activities[31](index=31&type=chunk) CASH FLOWS | CASH FLOWS | | | | :--- | :--- | :--- | | **For the nine months ended June 30, 2023 vs 2022** | | | | Net cash used in operating activities | $(15,293,299) (2023) | $(20,521,945) (2022) | | Net cash used in investing activities | $(3,262,500) (2023) | $(49,705,530) (2022) | | Net cash provided by financing activities | $(54,509) (2023) | $287,374 (2022) | | Change in cash and cash equivalents for the period | $(18,609,484) (2023) | $(69,956,928) (2022) | | Cash and cash equivalents, end of period | $38,466,991 (2023) | $67,868,096 (2022) | [Condensed Consolidated Interim Statement of Changes in Shareholders' Equity](index=17&type=section&id=Condensed%20Consolidated%20Interim%20Statement%20of%20Changes%20in%20Shareholders%27%20Equity) Shareholders' equity decreased due to net losses, partially offset by positive contributions from share-based payments - Total shareholders' equity decreased from **$167.1 million** at September 30, 2022, to **$150.2 million** at June 30, 2023, primarily due to net losses incurred during the period[33](index=33&type=chunk) - Share-based payments contributed positively to equity, totaling **$4.16 million** for the nine months ended June 30, 2023, reflecting the issuance of stock options and employee share purchase rights[33](index=33&type=chunk) SHAREHOLDERS' EQUITY | SHAREHOLDERS' EQUITY | | | | :--- | :--- | :--- | | **Balance, September 30, 2022** | $167,118,478 | | | Shares issued through employee share purchase plan | $50,291 | | | Share-based payments | $1,563,608 | | | Loss for the period | $(6,712,455) | | | **Balance, December 31, 2022** | $162,019,922 | | | Share-based payments | $1,437,091 | | | Loss for the period | $(7,119,354) | | | **Balance, March 31, 2023** | $156,337,659 | | | Share-based payments | $1,161,073 | | | Loss for the period | $(7,256,184) | | | **Balance, June 30, 2023** | $150,242,548 | | [Notes to Condensed Consolidated Interim Financial Statements](index=18&type=section&id=Notes%20to%20Condensed%20Consolidated%20Interim%20Financial%20Statements) These notes detail ESSA Pharma Inc.'s operations, accounting policies, financial instruments, and equity activities - ESSA Pharma Inc. is a clinical-stage pharmaceutical company focused on developing small molecule drugs for prostate cancer, with no products in commercial production as of June 30, 2023[34](index=34&type=chunk)[35](index=35&type=chunk) - The Company's short-term investments, classified as available-for-sale, increased to **$114.0 million** as of June 30, 2023, from **$110.2 million** at September 30, 2022, primarily driven by an increase in U.S. Treasury securities[46](index=46&type=chunk)[48](index=48&type=chunk)[49](index=49&type=chunk) - Shareholders' equity details include an Omnibus Incentive Plan with **8,410,907** common shares reserved for issuance and an Employee Share Purchase Plan (ESPP) with **217,300** common shares reserved[57](index=57&type=chunk)[58](index=58&type=chunk)[61](index=61&type=chunk) - The Company faces credit risk from cash and short-term investments, liquidity risk due to reliance on external financing, and market risk from interest rate and foreign currency fluctuations, though interest income is not central to its capital management[72](index=72&type=chunk)[74](index=74&type=chunk)[75](index=75&type=chunk)[76](index=76&type=chunk)[77](index=77&type=chunk) Short-term Investments (Fair Value) | Investment Type | June 30, 2023 ($) | September 30, 2022 ($) | | :--- | :--- | :--- | | U.S. Treasury securities | $72,122,617 | $11,149,183 | | GICs and Term deposits | $40,797,689 | $90,005,650 | | Corporate debt securities | $1,081,617 | $3,044,599 | | Commercial paper | — | $5,961,597 | | **Total Short-term Investments** | **$114,001,923** | **$110,161,029** | Accounts Payable and Accrued Liabilities | Category | June 30, 2023 ($) | September 30, 2022 ($) | | :--- | :--- | :--- | | Accounts payable | $2,050,602 | $954,598 | | Accrued expenses | $769,316 | $807,484 | | Accrued vacation | $476,459 | $414,483 | | **Total** | **$3,296,377** | **$2,176,565** | Stock Option Activity | Activity | Number of Options (June 30, 2023) | Weighted Average Exercise Price (June 30, 2023) ($) | | :--- | :--- | :--- | | Balance, September 30, 2022 | 7,902,061 | $5.13 | | Options granted | 300,000 | $2.97 | | Options expired/forfeited | (51,787) | $5.03 | | **Balance outstanding, June 30, 2023** | **8,150,274** | **$5.05** | | Balance exercisable, June 30, 2023 | 6,058,158 | $4.82 | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operation](index=31&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operation) Management discusses ESSA Pharma Inc.'s financial condition and operations, focusing on prostate cancer therapies and EPI-7386 development [Overview of Business and Product Candidates](index=31&type=section&id=Overview%20of%20Business%20and%20Product%20Candidates) ESSA is a clinical-stage pharmaceutical company developing novel prostate cancer therapies by disrupting the androgen receptor pathway - ESSA is a clinical-stage pharmaceutical company developing novel therapies for prostate cancer, particularly for patients whose disease progresses despite current standard-of-care treatments[80](index=80&type=chunk) - The Company's investigational compounds, including EPI-7386, are designed to disrupt the androgen receptor (AR) signaling pathway by selectively binding to the N-terminal domain (NTD) of the AR, a unique mechanism intended to bypass resistance mechanisms to current antiandrogens[80](index=80&type=chunk)[81](index=81&type=chunk)[86](index=86&type=chunk) - Prostate cancer is the second most frequently diagnosed cancer among men in the U.S., with a rising incidence of metastatic and non-metastatic castration-resistant prostate cancer (CRPC), representing a significant unmet therapeutic need that ESSA's Aniten series aims to address[82](index=82&type=chunk)[88](index=88&type=chunk) [Clinical Development of EPI-506 and Next-Generation Anitens](index=34&type=section&id=Clinical%20Development%20of%20EPI-506%20and%20Next-Generation%20Anitens) ESSA shifted from EPI-506 to EPI-7386, a next-generation Aniten with improved potency and metabolic stability - ESSA conducted a Phase 1 clinical study for its first-generation Aniten compound, EPI-506, which demonstrated favorable safety and some anti-tumor activity at higher doses, but its pharmacokinetic limitations led to the decision to discontinue further clinical development[90](index=90&type=chunk)[96](index=96&type=chunk)[97](index=97&type=chunk) - The Company shifted focus to next-generation Aniten compounds, with EPI-7386 selected as the lead candidate due to its significantly higher potency (**20x more than EPI-506**), increased metabolic stability, and improved pharmaceutical properties in preclinical studies[97](index=97&type=chunk)[98](index=98&type=chunk) [Our Strategy and Advancing EPI-7386](index=36&type=section&id=Our%20Strategy%20and%20Advancing%20EPI-7386) ESSA's strategy advances EPI-7386 through monotherapy and combination clinical trials, alongside preclinical studies - ESSA's strategy involves completing Phase 1 clinical development of EPI-7386 as a monotherapy, combining Aniten compounds with second-generation antiandrogens in earlier lines of therapy, and continuing preclinical studies on other Aniten molecules and NTD degraders[99](index=99&type=chunk)[100](index=100&type=chunk) - EPI-7386 was nominated as the lead clinical candidate in March 2019, with IND/CTA clearance in 2020, and clinical testing commenced in July 2020 for single agent and January 2022 for combination treatment with enzalutamide[102](index=102&type=chunk)[103](index=103&type=chunk) - The Phase 1a monotherapy dose escalation study for EPI-7386 has completed enrollment, with patients being dosed at **600 mg QD** and **1,200 mg/day (600 mg BID)**, both cleared as safe and tolerable, advancing to Phase 1b dose expansion[107](index=107&type=chunk)[109](index=109&type=chunk) - Combination studies are underway, including a Phase 1/2 study of EPI-7386 with enzalutamide (Astellas/Pfizer collaboration) and a clinical trial support agreement with Janssen to evaluate EPI-7386 with apalutamide or abiraterone acetate/prednisone in earlier patient populations[114](index=114&type=chunk)[115](index=115&type=chunk)[118](index=118&type=chunk)[119](index=119&type=chunk)[120](index=120&type=chunk)[121](index=121&type=chunk) [Recent Developments and Future Clinical Program](index=44&type=section&id=Recent%20Developments%20and%20Future%20Clinical%20Program) Recent developments include board appointments, new collaborations, and positive EPI-7386 clinical data, with plans for advanced trials - In 2023, ESSA appointed Lauren Merendino to its Board and entered a clinical trial support agreement with Janssen for combination studies of EPI-7386 with apalutamide or abiraterone acetate plus prednisone[127](index=127&type=chunk)[128](index=128&type=chunk) - February 2023 ASCO GU Symposium presentations showed EPI-7386 monotherapy was safe and well-tolerated up to **1200 mg/day**, with preliminary anti-tumor activity. Combination with enzalutamide showed a favorable safety profile and significant PSA decreases (**>90%**) in evaluable patients[129](index=129&type=chunk) - Janssen suspended enrollment in its combination study with EPI-7386 in October 2022 due to recruitment challenges, though initial clinical activity, including PSA90 reductions, was observed in some patients[130](index=130&type=chunk) - Future plans include potential Phase 2/3 single-agent trials for EPI-7386, contingent on identifying a predominantly AR-driven patient population, and continued randomized clinical trials for combination therapies in earlier prostate cancer stages[159](index=159&type=chunk)[160](index=160&type=chunk)[161](index=161&type=chunk)[162](index=162&type=chunk)[163](index=163&type=chunk) [Competition and Intellectual Property](index=54&type=section&id=Competition%20and%20Intellectual%20Property) The prostate cancer market is competitive, but EPI-7386's unique mechanism and extensive patent protection strengthen ESSA's position - The prostate cancer market is highly competitive, with numerous approved therapies and companies possessing greater financial resources and expertise. ESSA believes its competitive position is strong due to EPI-7386's unique mechanism of action targeting the AR-NTD, which bypasses common resistance pathways[164](index=164&type=chunk)[165](index=165&type=chunk) - ESSA has an exclusive worldwide license agreement with the British Columbia Cancer Agency and the University of British Columbia for intellectual property related to compounds modulating AR activity. The Company owns rights to **66 issued patents**, including **17 U.S. patents**, covering its Aniten structural classes, with **6 patents** specifically for EPI-7386, providing protection until **2036-2042**[166](index=166&type=chunk)[168](index=168&type=chunk)[172](index=172&type=chunk) Currently Approved Prostate Cancer Therapies | Generic/Program Name | Brand Name | Company Name(s) | | :--- | :--- | :--- | | Enzalutamide | Xtandi | Astellas and Pfizer | | Abiraterone acetate | Zytiga | Johnson & Johnson | | Apalutamide (ARN-509) | Erleada | Johnson & Johnson | | Darolutamide | Nubeqa | Bayer | | Pembrolizumab | Keytrude | Merck | | Olaparib | Lynparpar | AstraZeneca | | Rucaparib | Rubraca | Clovis Oncology | | Vipivotide tetraxetan | Pluvicto | Novartis | | Talazaparib (w/ enzalutamide) | Talzenna | Pfizer | [Regulatory Environment and Drug Development Process](index=56&type=section&id=Regulatory%20Environment%20and%20Drug%20Development%20Process) Drug development is subject to stringent global regulatory oversight, involving preclinical studies, multi-phase clinical trials, and FDA approval - The Company's R&D and manufacturing activities are subject to stringent global regulatory oversight by authorities like the FDA and Health Canada, requiring compliance with cGMP, GLP, and GCP standards[174](index=174&type=chunk)[175](index=175&type=chunk)[176](index=176&type=chunk) - The drug development process involves preclinical studies, submission of an Investigational New Drug (IND) application, and multi-phase human clinical trials (Phase 1, 2, and 3) to establish safety and efficacy[178](index=178&type=chunk)[179](index=179&type=chunk)[184](index=184&type=chunk)[185](index=185&type=chunk)[186](index=186&type=chunk) - Successful clinical development leads to a New Drug Application (NDA) submission, followed by FDA review, facility inspections, and potential post-approval requirements, including ongoing compliance and surveillance[188](index=188&type=chunk)[192](index=192&type=chunk)[195](index=195&type=chunk)[196](index=196&type=chunk) - Failure to comply with regulations can result in severe administrative or judicial sanctions, including refusal of approvals, product recalls, fines, and criminal penalties[177](index=177&type=chunk)[200](index=200&type=chunk) [Selected Quarterly Financial Information](index=65&type=section&id=Selected%20Quarterly%20Financial%20Information) ESSA consistently incurred net losses, with comprehensive losses of **$7.26 million** for the quarter and **$21.09 million** for the nine months - ESSA has consistently incurred net losses since its inception, with comprehensive losses of **$7.26 million** for the quarter ended June 30, 2023, and **$21.09 million** for the nine months ended June 30, 2023[205](index=205&type=chunk)[206](index=206&type=chunk) - The Company expects to continue incurring significant losses as it advances its product candidate through development and seeks regulatory approvals[205](index=205&type=chunk) Selected Quarterly Financial Data (Last 8 Quarters) | Metric | June 30, 2023 ($) | March 31, 2023 ($) | December 31, 2022 ($) | September 30, 2022 ($) | June 30, 2022 ($) | March 31, 2022 ($) | December 31, 2021 ($) | September 30, 2021 ($) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Research and development expense | $6,271,186 | $4,480,863 | $5,344,250 | $4,351,494 | $6,394,534 | $7,649,459 | $6,273,052 | $6,019,759 | | General and administration | $2,639,381 | $3,730,692 | $2,519,119 | $2,769,678 | $2,895,542 | $3,817,370 | $3,062,170 | $2,942,432 | | Comprehensive loss | $(7,256,184) | $(7,119,354) | $(6,712,455) | $(6,330,969) | $(8,829,694) | $(10,903,335) | $(9,097,919) | $(8,559,499) | | Basic and diluted loss per share | $(0.17) | $(0.16) | $(0.15) | $(0.14) | $(0.20) | $(0.25) | $(0.21) | $(0.19) | | Cash and cash equivalents | $38,466,991 | $44,300,677 | $51,220,602 | $57,076,475 | $67,868,096 | $86,235,830 | $121,058,121 | $137,825,024 | | Short-term investments | $114,001,923 | $112,743,037 | $111,850,895 | $110,161,029 | $106,727,807 | $94,782,609 | $68,141,166 | $57,102,159 | | Total assets | $153,650,198 | $158,504,040 | $165,003,340 | $169,505,295 | $175,660,846 | $182,609,005 | $191,486,181 | $198,165,818 | | Working capital | $149,882,729 | $155,967,246 | $161,652,689 | $166,748,942 | $171,150,678 | $178,353,354 | $187,291,085 | $193,668,414 | [Results of Operations for the Nine Months Ended June 30, 2023 and 2022](index=66&type=section&id=Results%20of%20Operations) Operating results show decreased R&D and G&A expenses for the nine months ended June 30, 2023 - For the nine months ended June 30, 2023, total research and development (R&D) expense decreased to **$16.1 million** from **$20.1 million** in the prior year, reflecting ongoing clinical trials for EPI-7386[206](index=206&type=chunk) - General and administrative (G&A) expenses decreased to **$8.9 million** for the nine months ended June 30, 2023, from **$9.8 million** in the prior year, including a non-cash share-based payments expense of **$2.02 million**[213](index=213&type=chunk) Research and Development Expenses (Nine Months Ended June 30) | Expense Category | 2023 ($) | 2022 ($) | | :--- | :--- | :--- | | Preclinical and data analysis | $4,765,110 | $6,045,555 | | Clinical | $4,230,255 | $3,731,044 | | Share-based payments | $2,140,972 | $3,253,741 | | Salaries and benefits | $2,017,145 | $1,516,507 | | Manufacturing | $1,810,716 | $3,970,564 | | Legal patents and license fees | $542,537 | $853,700 | | Consulting | $320,038 | $418,740 | | Travel and other | $119,600 | $117,798 | | Other | $87,152 | $73,618 | | Royalties | $62,774 | $82,485 | | **Total R&D** | **$16,096,299** | **$20,063,752** | General and Administrative Expenses (Nine Months Ended June 30) | Expense Category | 2023 ($) | 2022 ($) | | :--- | :--- | :--- | | Salaries and benefits | $3,483,710 | $3,021,159 | | Share-based payments | $2,020,803 | $2,700,703 | | Insurance | $1,400,414 | $1,448,983 | | Professional fees | $846,213 | $724,153 | | Investor relations | $483,995 | $454,646 | | Office, insurance, IT and communications | $417,835 | $414,620 | | Director fees | $288,667 | $254,250 | | Regulatory fees and transfer agent | $168,199 | $192,363 | | Travel and other | $164,072 | $109,215 | | Rent | $6,786 | $8,027 | | Consulting and subcontractor fees | — | $185,292 | | Amortization/(Accretion) | $(391,502) | $261,671 | | **Total G&A** | **$8,889,192** | **$9,775,082** | [Liquidity and Capital Resources](index=69&type=section&id=Liquidity%20and%20Capital%20Resources) ESSA maintains sufficient working capital and cash reserves for over twelve months, relying on external financing due to no revenue generation - As of June 30, 2023, ESSA had working capital of **$149.9 million** and available cash reserves and short-term investments of **$152.5 million**, which management believes is sufficient to satisfy obligations and planned expenditures for more than twelve months[221](index=221&type=chunk) - The Company does not generate revenue and relies on external financing, with future cash requirements subject to variability from preclinical work, strategic opportunities, and potential mergers or acquisitions[220](index=220&type=chunk)[222](index=222&type=chunk) [Critical Accounting Policies and Estimates & Trend Information](index=69&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates%20%26%20Trend%20Information) Financial statements rely on significant management estimates, with company success dependent on prostate cancer compound commercialization - The preparation of financial statements requires management to make significant estimates and assumptions, particularly in valuing equity instruments issued for services, with actual results potentially differing from these estimates[41](index=41&type=chunk)[223](index=223&type=chunk) - ESSA is a clinical development stage company with no current revenue, and its financial success is dependent on the successful development and commercialization of its prostate cancer compounds[226](index=226&type=chunk) [Outstanding Share Data](index=71&type=section&id=Outstanding%20Share%20Data) As of August 8, 2023, ESSA had **44,100,838** common shares outstanding, plus shares issuable from warrants and stock options - As of August 8, 2023, ESSA had **44,100,838** common shares issued and outstanding, with an unlimited number authorized. No preferred shares were issued[4](index=4&type=chunk)[228](index=228&type=chunk) - The Company also had **2,927,477** common shares issuable from warrants and **8,150,274** common shares issuable from outstanding stock options (**6,267,496** exercisable and **1,882,778** unexercisable)[228](index=228&type=chunk) [Item 3. Quantitative and Qualitative Disclosure About Market Risk](index=72&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosure%20About%20Market%20Risk) As a smaller reporting company, ESSA Pharma Inc. is exempt from detailed market risk disclosures under this item - ESSA Pharma Inc. is a smaller reporting company and is therefore exempt from providing the detailed market risk disclosures typically required under this item[231](index=231&type=chunk) [Item 4. Controls and Procedures](index=72&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded the Company's disclosure controls and internal control over financial reporting were effective as of June 30, 2023 - As of June 30, 2023, the Company's management, including the CEO and CFO, concluded that disclosure controls and procedures were effective at the reasonable assurance level[232](index=232&type=chunk)[233](index=233&type=chunk) - Management also assessed the effectiveness of internal control over financial reporting using the 2013 COSO framework and concluded it was effective as of June 30, 2023[234](index=234&type=chunk)[235](index=235&type=chunk) - There were no material changes in internal control over financial reporting during the quarter ended June 30, 2023[236](index=236&type=chunk) [PART II. OTHER INFORMATION](index=73&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=73&type=section&id=Item%201.%20Legal%20Proceedings) As of June 30, 2023, ESSA Pharma Inc. is not involved in legal proceedings expected to materially affect its business or financials - The Company is not currently involved in any legal proceedings that are anticipated to have a material adverse effect on its business or financial condition[238](index=238&type=chunk) [Item 1A. Risk Factors](index=73&type=section&id=Item%201A.%20Risk%20Factors) No material changes to risk factors have occurred since the Annual Report on Form 10-K for the year ended September 30, 2022 - No material changes to the Company's risk factors have occurred since those reported in the Annual Report on Form 10-K for the year ended September 30, 2022[239](index=239&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=73&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The Company reported no unregistered sales of equity securities or use of proceeds during the period - There were no unregistered sales of equity securities or use of proceeds to report[240](index=240&type=chunk) [Item 3. Defaults Upon Senior Securities](index=73&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The Company reported no defaults upon senior securities during the period - There were no defaults upon senior securities during the reporting period[241](index=241&type=chunk) [Item 4. Mine Safety Disclosures](index=73&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to ESSA Pharma Inc.'s operations - Mine safety disclosures are not applicable to the Company[242](index=242&type=chunk) [Item 5. Other Information](index=73&type=section&id=Item%205.%20Other%20Information) No other information was reported under this item - No other information was reported under this item[243](index=243&type=chunk) [Item 6. Exhibits, Financial Statement Schedules](index=74&type=section&id=Item%206.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section lists all exhibits filed as part of the Form 10-Q, including certifications, XBRL documents, and other corporate filings - The report includes certifications from the CEO and CFO (Exhibits **31.1, 31.2, 32.1**) and various Inline XBRL Taxonomy Extension Documents (Exhibits **101.INS, 101.SCH, 101.CAL, 101.LAB, 101.PRE, 101.DEF**)[248](index=248&type=chunk) - Other exhibits include Articles of Incorporation and a specimen common share certificate, incorporated by reference from previous SEC filings[248](index=248&type=chunk) [SIGNATURES](index=75&type=section&id=SIGNATURES) The Form 10-Q was signed on August 8, 2023, by David Parkinson (CEO) and David Wood (CFO) for ESSA Pharma Inc - The report was signed by David Parkinson, Chief Executive Officer, and David Wood, Chief Financial Officer, on August 8, 2023[251](index=251&type=chunk)

[Form 10-Q Filing Information](index=1&type=section&id=Form%2010-Q%20Filing%20Information) Details the filing and registrant status of the company's quarterly report - ESSA Pharma Inc. filed its Quarterly Report on Form 10-Q for the period ended March 31, 2023[2](index=2&type=chunk) Registrant Status | Status | Indication | | :-------------------- | :--------- | | Large accelerated filer | ☐ | | Accelerated filer | ☐ | | Non-accelerated filer | ☒ | | Smaller reporting company | ☒ | | Emerging growth company | ☐ | - As of May 9, 2023, the number of outstanding common shares was **44,092,374**[4](index=4&type=chunk) [Table of Contents](index=2&type=section&id=Table%20of%20Contents) Outlines the structure of the Quarterly Report on Form 10-Q, detailing its parts and items - The Table of Contents outlines the structure of the Quarterly Report on Form 10-Q, detailing Part I (Financial Information) and Part II (Other Information) with their respective items and page numbers[6](index=6&type=chunk) [Cautionary Note Regarding Forward-Looking Statements](index=3&type=section&id=CAUTIONARY%20NOTE%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) Warns that forward-looking statements involve risks and uncertainties causing actual results to differ materially - This section provides a cautionary note regarding forward-looking statements, highlighting that such statements involve known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially from those expressed or implied[7](index=7&type=chunk) - Key forward-looking statements include those related to maintaining operations, advancing product candidates through clinical trials, patient recruitment, collaborations, funding, therapeutic benefits, intellectual property protection, competition, profitability, and regulatory approvals[7](index=7&type=chunk) - A summary of material risk factors is provided, with a full discussion available in the Annual Report on Form 10-K[13](index=13&type=chunk) [PART I. FINANCIAL INFORMATION](index=12&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) Presents unaudited condensed consolidated interim financial statements and management's discussion and analysis [Item 1. Financial Statements and Supplementary Data](index=12&type=section&id=Item%201.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents ESSA Pharma Inc.'s unaudited condensed consolidated interim financial statements, including the balance sheets, statements of operations and comprehensive loss, statements of cash flows, and statements of changes in shareholders' equity, along with accompanying notes for the periods ended March 31, 2023 and 2022 [Condensed Consolidated Interim Balance Sheets](index=13&type=section&id=Condensed%20Consolidated%20Interim%20Balance%20Sheets) Provides a snapshot of the company's financial position, including assets, liabilities, and shareholders' equity Condensed Consolidated Interim Balance Sheets (as of March 31, 2023 vs. September 30, 2022) | Item | March 31, 2023 | September 30, 2022 | | :--------------------------------- | :------------- | :----------------- | | **ASSETS** | | | | Cash and cash equivalents | $44,300,677 | $57,076,475 | | Short-term investments | $112,743,037 | $110,161,029 | | Total assets | $158,504,040 | $169,505,295 | | **LIABILITIES AND SHAREHOLDERS' EQUITY** | | | | Total liabilities | $2,166,381 | $2,386,817 | | Total shareholders' equity | $156,337,659 | $167,118,478 | - Cash and cash equivalents decreased by **$12.77 million**, while short-term investments increased by **$2.58 million** from September 30, 2022, to March 31, 2023[28](index=28&type=chunk) - Total assets decreased by approximately **$11 million**, and total shareholders' equity decreased by approximately **$10.78 million** over the six-month period[28](index=28&type=chunk) [Condensed Consolidated Interim Statements of Operations and Comprehensive Loss](index=15&type=section&id=Condensed%20Consolidated%20Interim%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Details the company's financial performance, including revenues, expenses, and net loss over a period Condensed Consolidated Interim Statements of Operations and Comprehensive Loss (Six Months Ended March 31) | Item | 2023 | 2022 | | :--------------------------------- | :------------- | :------------- | | Research and development | $9,825,113 | $13,669,218 | | General and administration | $6,249,811 | $6,879,540 | | Total operating expenses | $(16,079,218) | $(20,556,609) | | Interest and other income | $2,267,926 | $556,335 | | Net loss for the period | $(13,802,121) | $(19,952,523) | | Comprehensive loss for the period | $(13,831,809) | $(20,001,254) | | Basic and diluted loss per common share | $(0.31) | $(0.45) | - Net loss for the six months ended March 31, 2023, decreased to **$13.8 million** from **$19.95 million** in the prior year, primarily due to lower research and development expenses[30](index=30&type=chunk) - Interest and other income significantly increased to **$2.27 million** in 2023 from **$0.56 million** in 2022[30](index=30&type=chunk) [Condensed Consolidated Interim Statements of Cash Flows](index=16&type=section&id=Condensed%20Consolidated%20Interim%20Statements%20of%20Cash%20Flows) Summarizes cash inflows and outflows from operating, investing, and financing activities Condensed Consolidated Interim Statements of Cash Flows (Six Months Ended March 31) | Item | 2023 | 2022 | | :--------------------------------- | :------------- | :------------- | | Net cash used in operating activities | $(11,968,934) | $(14,204,791) | | Net cash used in investing activities | $(790,073) | $(37,625,805) | | Net cash provided by financing activities | $(18,987) | $282,446 | | Change in cash and cash equivalents for the period | $(12,775,798) | $(51,589,194) | | Cash and cash equivalents, end of period | $44,300,677 | $86,235,830 | - Net cash used in operating activities decreased by approximately **$2.24 million**, while net cash used in investing activities significantly decreased by approximately **$36.84 million**, primarily due to changes in short-term investment purchases and proceeds[31](index=31&type=chunk) - The overall change in cash and cash equivalents for the period showed a decrease of **$12.78 million** in 2023, a substantial improvement from the **$51.59 million** decrease in 2022[31](index=31&type=chunk) [Condensed Consolidated Interim Statement of Changes in Shareholders' Equity](index=17&type=section&id=Condensed%20Consolidated%20Interim%20Statement%20of%20Changes%20in%20Shareholders'%20Equity) Tracks changes in the company's equity accounts over a period, including net loss and share-based payments Condensed Consolidated Interim Statement of Changes in Shareholders' Equity (Six Months Ended March 31, 2023) | Item | Number of shares | Common shares | Additional paid-in capital | Accumulated other comprehensive loss | Deficit | Total | | :------------------------- | :--------------- | :------------ | :------------------------- | :--------------------------------- | :-------------- | :------------ | | Balance, September 30, 2022 | 44,073,076 | $278,089,136 | $44,043,503 | $(2,135,145) | $(152,879,016) | $167,118,478 | | Shares issued through ESPP | 19,298 | $52,392 | $(2,101) | — | — | $50,291 | | Share-based payments | — | — | $1,563,608 | — | — | $1,563,608 | | Loss for the period | — | — | — | $29,427 | $(6,741,882) | $(6,712,455) | | Balance, December 31, 2022 | 44,092,374 | $278,141,528 | $45,605,010 | $(2,105,718) | $(159,620,898) | $162,019,922 | | Share-based payments | — | — | $1,437,091 | — | — | $1,437,091 | | Loss for the period | — | — | — | $(59,115) | $(7,060,239) | $(7,119,354) | | Balance, March 31, 2023 | 44,092,374 | $278,141,528 | $47,042,101 | $(2,164,833) | $(166,681,137) | $156,337,659 | - Total shareholders' equity decreased from **$167.1 million** at September 30, 2022, to **$156.3 million** at March 31, 2023, primarily due to the net loss incurred during the period[33](index=33&type=chunk) - Share-based payments contributed **$3.0 million** to additional paid-in capital during the six months ended March 31, 2023[33](index=33&type=chunk) [Notes to Condensed Consolidated Interim Financial Statements](index=18&type=section&id=Notes%20to%20Condensed%20Consolidated%20Interim%20Financial%20Statements) Provides additional details and explanations for the figures presented in the financial statements [Nature of Operations](index=18&type=section&id=Nature%20of%20Operations) Describes the company's primary business activities and its stage of development - ESSA Pharma Inc. is a clinical-stage company focused on developing small molecule drugs for prostate cancer, with no products currently in commercial production or use[36](index=36&type=chunk) [Basis of Presentation](index=18&type=section&id=Basis%20of%20Presentation) Explains the accounting principles and conventions used in preparing the financial statements - The unaudited condensed consolidated interim financial statements are prepared in accordance with U.S. GAAP and SEC rules, reflecting normal recurring adjustments and are expressed in United States dollars[37](index=37&type=chunk)[38](index=38&type=chunk)[40](index=40&type=chunk) [Recent Accounting Pronouncements](index=20&type=section&id=Recent%20Accounting%20Pronouncements) Discusses the potential impact of newly issued accounting standards on the company's financial reporting - Management believes that recently issued, but not yet effective, accounting standards would not have a material effect on the Company's financial statements[43](index=43&type=chunk)[44](index=44&type=chunk) [Short-Term Investments](index=21&type=section&id=Short-Term%20Investments) Details the composition and fair value of the company's short-term investment portfolio - Short-term investments, classified as available-for-sale, include GICs, U.S. treasury securities, and corporate debt securities, carried at fair value with unrealized gains/losses in accumulated other comprehensive loss[47](index=47&type=chunk) Short-Term Investments (as of March 31, 2023) | Item | Amortized Cost | Unrealized Losses | Estimated Fair Value | | :-------------------- | :------------- | :---------------- | :------------------- | | GICs and Term deposits | $40,043,353 | — | $40,322,846 | | U.S. Treasury securities | $71,334,448 | $(84,966) | $71,354,575 | | Corporate debt securities | $1,068,360 | $(3,388) | $1,065,616 | | Balance, end of period | $112,446,161 | $(88,354) | $112,743,037 | - As of March 31, 2023, short-term investments had an aggregate fair market value of **$112.7 million** and an aggregate gross unrealized loss of **$88,354**, primarily due to current economic and market conditions[48](index=48&type=chunk) [Prepaids](index=23&type=section&id=Prepaids) Itemizes the company's prepaid expenses and other deposits Prepaids (as of March 31, 2023 vs. September 30, 2022) | Item | March 31, 2023 | September 30, 2022 | | :--------------------------------- | :------------- | :----------------- | | Prepaid insurance | $623,031 | $1,611,516 | | Prepaid CMC and clinical expenses and deposits | $181,835 | $181,835 | | Other deposits and prepaid expenses | $256,487 | $22,275 | | Balance, end of period | $1,061,353 | $1,815,626 | - Total prepaids decreased from **$1.82 million** at September 30, 2022, to **$1.06 million** at March 31, 2023, mainly due to a reduction in prepaid insurance[49](index=49&type=chunk) [Accounts Payable and Accrued Liabilities](index=23&type=section&id=Accounts%20Payable%20and%20Accrued%20Liabilities) Lists the company's short-term financial obligations to vendors and for accrued expenses Accounts Payable and Accrued Liabilities (as of March 31, 2023 vs. September 30, 2022) | Item | March 31, 2023 | September 30, 2022 | | :-------------------- | :------------- | :----------------- | | Accounts payable | $1,195,783 | $954,598 | | Accrued expenses | $359,160 | $807,484 | | Accrued vacation | $466,170 | $414,483 | | Balance, end of period | $2,021,113 | $2,176,565 | - Total accounts payable and accrued liabilities decreased from **$2.18 million** at September 30, 2022, to **$2.02 million** at March 31, 2023, primarily due to a reduction in accrued expenses[50](index=50&type=chunk) [Operating Lease](index=23&type=section&id=Operating%20Lease) Details the company's operating lease assets and liabilities Operating Lease Right-of-Use Assets and Liabilities (as of March 31, 2023) | Item | Amount | | :--------------------------------- | :------------- | | Operating lease right-of-use assets | $125,605 | | Operating lease liabilities | $145,268 | | Current portion of operating lease liabilities | $125,491 | | Non-current operating lease liabilities | $19,777 | - The Company recognized accretion expense of **$4,294** for the six months ended March 31, 2023, recorded in financing costs[53](index=53&type=chunk) - The remaining lease terms for the South San Francisco office was **14 months** and Houston office was **4 months** as of March 31, 2023, with an incremental borrowing rate of **5.0%**[52](index=52&type=chunk) [Shareholders' Equity](index=25&type=section&id=Shareholders'%20Equity) Provides information on the company's capital structure, including share issuance and share-based compensation - The Company has an Omnibus Incentive Plan with a maximum of **8,410,907** common shares reserved for issuance and an Employee Share Purchase Plan (ESPP) with **217,300** common shares reserved[57](index=57&type=chunk)[58](index=58&type=chunk) - During the six months ended March 31, 2023, **19,298** shares were issued under the ESPP, and **195,000** stock options were granted with a weighted average fair value of **$2.76** per option[61](index=61&type=chunk)[66](index=66&type=chunk) Share-Based Compensation Expense (Six Months Ended March 31) | Expense Category | 2023 | 2022 | | :------------------------- | :------------- | :------------- | | Research and development | $1,539,999 | $2,369,077 | | General and administration | $1,458,857 | $1,975,277 | | Total | $2,998,856 | $4,344,354 | [Related Party Transactions](index=28&type=section&id=Related%20Party%20Transactions) Discloses transactions between the company and its key management personnel or other related entities - As of March 31, 2023, **$94,857** was due to related parties for key management personnel compensation and expense reimbursements, which are non-interest bearing with no fixed repayment terms[68](index=68&type=chunk) [Segmented Information](index=28&type=section&id=Segmented%20Information) Identifies the company's operating segments and their financial performance - The Company operates in a single industry segment: the development of small molecule drugs for prostate cancer[69](index=69&type=chunk) [Financial Instruments and Risk](index=28&type=section&id=Financial%20Instruments%20and%20Risk) Discusses the company's financial instruments and its exposure to various financial risks - The Company's financial instruments include cash and cash equivalents, short-term investments, receivables, and accounts payable and accrued liabilities, with fair values approximating carrying values due to their short-term nature[70](index=70&type=chunk) - The Company manages credit risk by placing cash with major financial institutions and maintaining an investment policy for short-term investments[72](index=72&type=chunk) - Liquidity risk is managed by ensuring sufficient liquidity; as of March 31, 2023, the Company had working capital of **$155,967,246** and relies on external financing as it does not generate revenue[74](index=74&type=chunk) - Market risks include interest rate risk (not significant to operational budget) and foreign currency risk (primarily Canadian dollar exposure, with a **10%** change impacting net gain by **$1,988**)[75](index=75&type=chunk)[76](index=76&type=chunk)[77](index=77&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operation](index=31&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operation) This section provides management's perspective on the Company's financial condition, results of operations, and future outlook. It details ESSA's strategic focus on developing novel therapies for prostate cancer, particularly its lead product candidate EPI-7386, and discusses clinical trial progress, collaborations, intellectual property, regulatory environment, and financial performance [Overview](index=31&type=section&id=Overview) Provides a high-level introduction to the company's business, strategic focus, and product candidates - ESSA is a clinical-stage pharmaceutical company focused on developing novel small molecule drugs, specifically Aniten compounds like EPI-7386, for the treatment of prostate cancer, particularly castration-resistant prostate cancer (CRPC)[79](index=79&type=chunk) - The Aniten compounds are designed to disrupt the androgen receptor (AR) signaling pathway by selectively binding to the N-terminal domain (NTD) of the AR, a unique mechanism intended to bypass resistance mechanisms to current antiandrogens[79](index=79&type=chunk)[85](index=85&type=chunk) - Preclinical studies have shown Aniten compounds can shrink AR-dependent prostate cancer xenografts, including those resistant to second-generation antiandrogens, supporting their potential efficacy[85](index=85&type=chunk) [Completed Phase 1 Clinical Study of EPI-506](index=34&type=section&id=Completed%20Phase%201%20Clinical%20Study%20of%20EPI-506) Summarizes the findings and outcomes of the initial Phase 1 clinical trial for EPI-506 - The initial Phase 1 clinical study of EPI-506, a first-generation Aniten compound, explored safety, tolerability, pharmacokinetics, and anti-tumor activity in mCRPC patients refractory to current standard of care[89](index=89&type=chunk)[91](index=91&type=chunk) - EPI-506 was generally well-tolerated, with PSA declines observed in some patients, predominantly at higher doses (≥**1280 mg**)[94](index=94&type=chunk)[95](index=95&type=chunk) - Despite favorable safety and signs of anti-tumor activity, pharmacokinetic and metabolic studies revealed limitations, leading to the decision to discontinue EPI-506's clinical development and focus on next-generation Anitens[96](index=96&type=chunk) [Next Generation Aniten Molecules](index=36&type=section&id=Next%20Generation%20Aniten%20Molecules) Introduces the company's advanced Aniten compounds, highlighting their improved properties and potential - The Company's next-generation Aniten compounds, including EPI-7386, demonstrate significantly higher potency (**20** times higher than EPI-506), increased metabolic stability, and more favorable pharmaceutical properties in preclinical studies[97](index=97&type=chunk) [Our Strategy](index=36&type=section&id=Our%20Strategy) Outlines the company's strategic approach to clinical development, combination therapies, and preclinical research - ESSA's strategy includes pursuing EPI-7386 as a monotherapy for mCRPC patients resistant to current standard of care, combining Aniten compounds with second-generation antiandrogens in earlier lines of therapy, and advancing preclinical development of NTD degraders (ANITACs)[98](index=98&type=chunk) [The Identification and Characteristics of EPI-7386](index=38&type=section&id=The%20Identification%20and%20Characteristics%20of%20EPI-7386) Describes the selection and key attributes of EPI-7386 as the lead clinical candidate - EPI-7386 was nominated as the lead clinical candidate due to its increased potency, reduced metabolic susceptibility, superior pharmaceutical properties, and favorable tolerability profile in preclinical studies[100](index=100&type=chunk)[101](index=101&type=chunk) - An IND was submitted to the FDA on March 30, 2020, and clinical testing commenced in July 2020[102](index=102&type=chunk) [Advancing EPI-7386 Through Clinical Development](index=38&type=section&id=Advancing%20EPI-7386%20Through%20Clinical%20Development) Details the progress and design of the ongoing Phase 1 clinical trial for EPI-7386 - The Phase 1 clinical trial of EPI-7386 (NCT04421222) is actively enrolling nmCRPC and mCRPC patients, with protocol amendments allowing for higher dosages (**800 mg/day** and **1200 mg/day**) and focusing on less heavily pretreated patients[103](index=103&type=chunk) - Part 1a (dose escalation) has completed enrollment, with **1,000 mg** QD and **1,200 mg/day** BID doses cleared as safe and tolerable. Two dose levels (**600 mg** QD and **600 mg** BID) have advanced to Phase 1b dose expansion testing[106](index=106&type=chunk)[108](index=108&type=chunk) - Part 1b includes Cohort A (dose expansion for mCRPC, combined with apalutamide after **12 weeks**) and Cohort B (window of opportunity for nmCRPC, assessing anti-tumor activity of single-agent EPI-7386)[109](index=109&type=chunk)[110](index=110&type=chunk) [Combination Studies – Developing a New Standard of Care for the Treatment of Prostate Cancer](index=40&type=section&id=Combination%20Studies%20%E2%80%93%20Developing%20a%20New%20Standard%20of%20Care%20for%20the%20Treatment%20of%20Prostate%20Cancer) Discusses the company's efforts to evaluate EPI-7386 in combination with other antiandrogens - The Company believes NTD inhibition of AR-directed biology, effective against both full-length AR and splice variants, makes it an ideal target for combination therapy with current antiandrogens[112](index=112&type=chunk) - A collaboration with Janssen Research & Development, LLC to study EPI-7386 in combination with abiraterone acetate or apalutamide was suspended due to recruitment challenges; ESSA has now entered a clinical trial support agreement to sponsor and conduct the study[113](index=113&type=chunk)[114](index=114&type=chunk)[119](index=119&type=chunk) - A Phase 1/2 study with Astellas Pharma Inc. and Pfizer Inc. evaluating EPI-7386 in combination with enzalutamide in mCRPC patients was initiated in January 2022, showing favorable safety and preliminary PSA responses[115](index=115&type=chunk) [Preclinical Development of Anitens, Degraders, and Other Indications](index=42&type=section&id=Preclinical%20Development%20of%20Anitens,%20Degraders,%20and%20Other%20Indications) Highlights ongoing preclinical research into novel Aniten compounds and degraders - ESSA is advancing preclinical development of AR ANITen bAsed Chimera (ANITAC) NTD degraders, which have shown potential to degrade AR full length and splice variants in CRPC preclinical models[116](index=116&type=chunk)[140](index=140&type=chunk) [Recent Developments](index=42&type=section&id=Recent%20Developments) Provides updates on significant events, clinical trial results, and collaborations - In April 2023, ESSA announced a clinical trial support agreement with Janssen to sponsor and conduct a Phase 1 study of EPI-7386 in combination with apalutamide or abiraterone acetate plus prednisone[119](index=119&type=chunk) - February 2023 ASCO GU Symposium presentations showed EPI-7386 monotherapy was safe and well-tolerated up to **1200 mg** daily, with preliminary anti-tumor activity in heavily pretreated mCRPC patients[121](index=121&type=chunk) - Preliminary results from the EPI-7386 + enzalutamide combination trial indicated safety, minimal impact on enzalutamide exposure, and PSA decreases **>90%** in **five out of six** evaluable patients[121](index=121&type=chunk)[123](index=123&type=chunk) [Future Clinical Development Program](index=50&type=section&id=Future%20Clinical%20Development%20Program) Outlines the anticipated next steps and potential pathways for EPI-7386's clinical advancement - Depending on Phase 1 results, a Phase 2 single-arm clinical trial evaluating EPI-7386 monotherapy in biologically-characterized mCRPC patients might be conducted, focusing on those with predominantly AR-driven tumors[153](index=153&type=chunk)[154](index=154&type=chunk) - Ultimately, at least one Phase 3 clinical trial, likely with progression-free survival or overall survival as the key endpoint, is expected for single-agent regulatory approval[155](index=155&type=chunk) [Competition](index=52&type=section&id=Competition) Assesses the competitive landscape within the prostate cancer treatment market - The prostate cancer market is highly competitive, with many companies possessing greater financial resources and expertise[156](index=156&type=chunk) Currently Approved Therapies for Prostate Cancer | Name | Brand Name | Company Name(s) | | :---------------- | :--------- | :---------------- | | Enzalutamide | Xtandi | Astellas and Pfizer | | Abiraterone acetate | Zytiga | Johnson & Johnson | | Apalutamide (ARN-509) | Erleada | Johnson & Johnson | | Darolutamide | Nubeqa | Bayer | | Pembrolizumab | Keytruda | Merck | | Olaparib | Lynparpar | AstraZeneca | - ESSA believes its competitive position is strong due to its mechanistically unique approach of blocking AR activation via the NTD, which has the potential to bypass AR-dependent resistance pathways[159](index=159&type=chunk) [Patents and Proprietary Rights](index=54&type=section&id=Patents%20and%20Proprietary%20Rights) Details the company's intellectual property portfolio and licensing agreements - ESSA has an exclusive worldwide license agreement with UBC and BCCA for intellectual property related to compounds that modulate AR activity, requiring annual royalties and milestone payments[162](index=162&type=chunk)[163](index=163&type=chunk)[164](index=164&type=chunk) - As of April 2023, ESSA owns rights to **64** issued patents, including **17** U.S. patents, with **6** specifically covering EPI-7386, providing protection until 2036-2042[166](index=166&type=chunk) [Regulatory Environment](index=56&type=section&id=Regulatory%20Environment) Describes the extensive regulatory framework governing drug development and approval - The Company's R&D and product manufacturing are subject to extensive regulation by governmental authorities like the FDA in the U.S. and TPD in Canada, requiring compliance with cGMP, GLP, and GCP standards[169](index=169&type=chunk) - The drug development process involves preclinical studies, IND/CTA submission, IRB approval, human clinical trials (Phase 1, 2, 3), New Drug Application (NDA) or New Drug Submission (NDS), and post-approval requirements[172](index=172&type=chunk) - Failure to comply with regulatory requirements can lead to severe administrative or judicial sanctions, including refusal of approval, withdrawal of approval, product recalls, and fines[170](index=170&type=chunk)[191](index=191&type=chunk) [Orphan Designation and Exclusivity](index=62&type=section&id=Orphan%20Designation%20and%20Exclusivity) Explains the potential benefits of orphan drug designation for product candidates - ESSA may seek orphan drug designation for its product candidates, which could grant **7 years** of market exclusivity if approved for a rare disease or condition[194](index=194&type=chunk)[195](index=195&type=chunk) [Selected Quarterly Financial Information](index=62&type=section&id=Selected%20Quarterly%20Financial%20Information) Presents a summary of key financial data for recent quarterly periods Selected Quarterly Financial Data (March 31, 2023 vs. March 31, 2022) | Item | March 31, 2023 | March 31, 2022 | | :------------------------- | :------------- | :------------- | | Research and development expense | $4,480,863 | $7,649,459 | | General and administration | $3,730,692 | $3,817,370 | | Comprehensive loss | $(7,119,354) | $(10,903,335) | | Basic and diluted loss per share | $(0.16) | $(0.25) | | Cash and cash equivalents | $44,300,677 | $86,235,830 | | Short-term investments | $112,743,037 | $94,782,609 | | Total assets | $158,504,040 | $182,609,005 | | Working capital | $155,967,246 | $178,353,354 | - The Company has consistently incurred net losses since inception and expects this trend to continue as it develops its product candidates[198](index=198&type=chunk) [Results of Operations for the Six Months Ended March 31, 2023 and 2022](index=64&type=section&id=Results%20of%20Operations%20for%20the%20Six%20Months%20Ended%20March%2031,%202023%20and%202022) Analyzes the company's financial performance over the six-month periods - Comprehensive loss for the six months ended March 31, 2023, was **$13.8 million**, a decrease from **$20.0 million** in the prior year, with no revenue generated in either period[199](index=199&type=chunk) Research and Development Expenses (Six Months Ended March 31) | Expense Category | 2023 | 2022 | | :------------------------- | :------------- | :------------- | | Preclinical and data analysis | $3,206,613 | $4,176,532 | | Clinical | $2,003,198 | $1,974,061 | | Share-based payments | $1,541,351 | $2,381,210 | | Salaries and benefits | $1,312,510 | $1,146,817 | | Manufacturing | $1,112,899 | $2,979,363 | | Total R&D Expense | $9,825,113 | $13,669,218 | - The decrease in R&D expense was primarily driven by lower manufacturing costs (**$1.1M** in 2023 vs. **$3.0M** in 2022) and share-based payments, partially offset by increased salaries and benefits due to more staff[199](index=199&type=chunk)[202](index=202&type=chunk)[203](index=203&type=chunk) General and Administration Expenses (Six Months Ended March 31) | Expense Category | 2023 | 2022 | | :------------------------- | :------------- | :------------- | | Salaries and benefits | $2,726,717 | $2,148,296 | | Share-based payments | $1,459,351 | $1,982,234 | | Insurance | $923,760 | $966,903 | | Professional fees | $334,930 | $525,742 | | Total G&A Expense | $6,249,811 | $6,879,540 | - General and administration expenses decreased due to lower share-based payments and professional fees, despite an increase in salaries and benefits for corporate staff[206](index=206&type=chunk)[207](index=207&type=chunk) [Three Months Ended March 31, 2023 and 2022](index=68&type=section&id=Three%20Months%20Ended%20March%2031,%202023%20and%202022) Analyzes the company's financial performance over the three-month periods - Comprehensive loss for the three months ended March 31, 2023, was **$7.1 million**, down from **$10.9 million** in the same period of 2022[210](index=210&type=chunk) - Research and development expenses decreased to **$4.5 million** (2023) from **$7.6 million** (2022), driven by lower clinical, preclinical, and manufacturing costs[211](index=211&type=chunk) - General and administration expenses were **$3.7 million** (2023) compared to **$3.8 million** (2022), with professional fees decreasing but salaries and benefits increasing due to annual bonuses[212](index=212&type=chunk) [Liquidity and Capital Resources](index=68&type=section&id=Liquidity%20and%20Capital%20Resources) Discusses the company's cash position, working capital, and funding outlook - As of March 31, 2023, the Company had working capital of **$155,967,246** and available cash reserves and short-term investments of **$157,043,714**[215](index=215&type=chunk) - The Company believes it has sufficient capital to satisfy its obligations and execute planned expenditures for more than **twelve months**[215](index=215&type=chunk) - Future cash requirements may necessitate raising additional funds through strategic collaborations, equity issuance, or other financing sources[216](index=216&type=chunk) [Critical Accounting Policies and Estimates](index=68&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) Explains the significant accounting judgments and estimates made by management - The preparation of financial statements requires management to make estimates and assumptions about future events, which are continually evaluated based on historical experience and expectations[217](index=217&type=chunk) [Trend Information](index=70&type=section&id=Trend%20Information) Identifies key trends impacting the company's financial condition and operations - As a clinical development stage company, ESSA does not generate revenue, and its financial success is dependent on the successful development and commercialization of its prostate cancer drug compounds[221](index=221&type=chunk) [Off-Balance Sheet Arrangement](index=70&type=section&id=Off-Balance%20Sheet%20Arrangement) Discloses any material off-balance sheet arrangements - ESSA has no material undisclosed off-balance sheet arrangements that would significantly affect its financial condition or results of operations[222](index=222&type=chunk) [Outstanding Share Data](index=70&type=section&id=Outstanding%20Share%20Data) Provides details on the company's issued and outstanding shares and potential dilutive securities - As of May 9, 2023, the Company had **44,092,374** common shares issued and outstanding, along with **2,927,477** common shares issuable from warrants and **8,045,274** from outstanding stock options[223](index=223&type=chunk) [Item 3. Quantitative and Qualitative Disclosure About Market Risk](index=71&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosure%20About%20Market%20Risk) As a smaller reporting company, ESSA Pharma Inc. is not required to provide the detailed quantitative and qualitative disclosures about market risk typically mandated for larger filers - The Company is a smaller reporting company and is not required to provide the information required under this item[226](index=226&type=chunk) [Item 4. Controls and Procedures](index=71&type=section&id=Item%204.%20Controls%20and%20Procedures) This section details the evaluation of the Company's disclosure controls and procedures and management's assessment of internal control over financial reporting, concluding on their effectiveness - Management, with CEO and CFO participation, evaluated the design and operating effectiveness of disclosure controls and procedures, concluding they were effective at a reasonable assurance level as of March 31, 2023[227](index=227&type=chunk)[228](index=228&type=chunk) - Management also assessed the effectiveness of internal control over financial reporting using the 2013 COSO framework, concluding it was effective as of March 31, 2023[229](index=229&type=chunk)[230](index=230&type=chunk) - There were no material changes in internal control over financial reporting during the quarter ended March 31, 2023[231](index=231&type=chunk) [PART II. OTHER INFORMATION](index=72&type=section&id=PART%20II.%20OTHER%20INFORMATION) Presents additional information not covered in the financial section, including legal and regulatory matters [Item 1. Legal Proceedings](index=72&type=section&id=Item%201.%20Legal%20Proceedings) Reports on any legal proceedings involving the Company - As of March 31, 2023, ESSA Pharma Inc. is not a party to any legal proceedings that would reasonably be expected to have a material adverse effect on its business, financial condition, operating results, or cash flows[233](index=233&type=chunk) [Item 1A. Risk Factors](index=72&type=section&id=Item%201A.%20Risk%20Factors) Addresses any material changes to the risk factors previously disclosed by the Company - There have been no material changes in the Company's risk factors from those disclosed in its Annual Report on Form 10-K for the year ended September 30, 2022[234](index=234&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=72&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) Reports on any unregistered sales of equity securities and the use of proceeds from such sales - The Company reported no unregistered sales of equity securities or use of proceeds for the period[235](index=235&type=chunk) [Item 3. Defaults Upon Senior Securities](index=72&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) Discloses any defaults upon senior securities - The Company reported no defaults upon senior securities for the period[236](index=236&type=chunk) [Item 4. Mine Safety Disclosures](index=72&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Provides disclosures related to mine safety - This item is not applicable to the Company[237](index=237&type=chunk) [Item 5. Other Information](index=72&type=section&id=Item%205.%20Other%20Information) Includes any other information not covered by previous items - The Company reported no other information for the period[238](index=238&type=chunk) [Item 6. Exhibits, Financial Statement Schedules](index=73&type=section&id=Item%206.%20Exhibits,%20Financial%20Statement%20Schedules) Lists the exhibits and financial statement schedules filed as part of the Form 10-Q - The report includes a list of exhibits, such as Articles of Incorporation, specimen common share certificate, certifications of CEO and CFO, and Inline XBRL documents[242](index=242&type=chunk) [SIGNATURES](index=74&type=section&id=SIGNATURES) Confirms the official signing and certification of the report by authorized officers - The report is duly signed on behalf of ESSA Pharma Inc. by David Parkinson, Chief Executive Officer, and David Wood, Chief Financial Officer, as of May 9, 2023[244](index=244&type=chunk)[245](index=245&type=chunk)

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended December 31, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-37410 ESSA Pharma Inc. (Exact name of registrant as specified in its charter) British Columbia, Canada 98- ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended September 30, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-37410 Title of each class Trading Symbol(s) Name of each exchange on which registered Common Shares EPIX Nasdaq Capital Market ESSA ...

[Part I: Financial Information](index=11&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Financial Statements](index=11&type=section&id=Item%201.%20Financial%20Statements%20and%20Supplementary%20Data) ESSA Pharma, a clinical-stage company, reported a net loss of $28.8 million for the nine months ended June 30, 2022, maintaining a strong liquidity position of $174.6 million in cash and investments Condensed Consolidated Balance Sheet (Unaudited) | Account | June 30, 2022 ($) | September 30, 2021 ($) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $67,868,096 | $137,825,024 | | Short-term investments | $106,727,807 | $57,102,159 | | Total Current Assets | $175,184,445 | $197,598,077 | | **Total Assets** | **$175,660,846** | **$198,165,818** | | **Liabilities & Equity** | | | | Total Current Liabilities | $4,033,767 | $3,929,663 | | Total Liabilities | $4,145,040 | $4,160,266 | | Total Shareholders' Equity | $171,515,806 | $194,005,552 | | **Total Liabilities and Shareholders' Equity** | **$175,660,846** | **$198,165,818** | Condensed Consolidated Statements of Operations (Unaudited) | Account | Three Months Ended June 30, 2022 ($) | Nine Months Ended June 30, 2022 ($) | | :--- | :--- | :--- | | Research and development | $6,394,534 | $20,063,752 | | General and administration | $2,895,542 | $9,775,082 | | Total operating expenses | ($9,293,221) | ($29,849,830) | | **Net loss for the period** | **($8,826,743)** | **($28,779,266)** | | **Loss per common share (basic and diluted)** | **($0.20)** | **($0.65)** | Condensed Consolidated Statements of Cash Flows (Unaudited, Nine Months Ended June 30) | Cash Flow Activity | 2022 ($) | 2021 ($) | | :--- | :--- | :--- | | Net cash used in operating activities | ($20,848,215) | ($18,032,326) | | Net cash used in investing activities | ($49,379,260) | ($35,014,766) | | Net cash provided by financing activities | $287,374 | $141,977,430 | | **Change in cash and cash equivalents** | **($69,956,928)** | **$88,873,418** | [Management's Discussion and Analysis (MD&A)](index=31&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) ESSA Pharma, a clinical-stage company, is advancing EPI-7386 for CRPC in Phase 1/2 trials, with a slight increase in net loss to $28.8 million for the nine months ended June 30, 2022, while maintaining strong liquidity [Overview and Strategy](index=31&type=section&id=Overview%20and%20Strategy) ESSA is a clinical-stage pharmaceutical company developing EPI-7386, a first-in-class AR-NTD inhibitor for CRPC, aiming to overcome treatment resistance through monotherapy and combination strategies - The company is focused on developing proprietary therapies for prostate cancer, specifically for patients whose disease is progressing despite standard-of-care treatments[97](index=97&type=chunk) - EPI-7386 is designed to disrupt the androgen receptor (AR) signaling pathway by selectively binding to the N-terminal domain (NTD), a mechanism different from current antiandrogens that target the ligand-binding domain (LBD), which may bypass common resistance mechanisms[97](index=97&type=chunk)[98](index=98&type=chunk) - The company's strategy includes pursuing clinical development of EPI-7386 as a monotherapy for CRPC, conducting clinical trials of EPI-7386 in combination with second-generation antiandrogens, and continuing preclinical development of next-generation compounds, including NTD degraders (ANITACs)[115](index=115&type=chunk) [Clinical Program and Recent Developments](index=38&type=section&id=Clinical%20Program%20and%20Recent%20Developments) EPI-7386's Phase 1a trial demonstrated safety and initial anti-tumor activity, leading to advancement into Phase 1b expansion and combination studies, alongside positive preclinical data for ANITAC™ NTD degraders - The Phase 1 trial of EPI-7386 is actively enrolling patients, with protocol amendments focusing on less heavily pretreated mCRPC patients to increase the likelihood of response[120](index=120&type=chunk)[124](index=124&type=chunk) - The company has established collaborations to test EPI-7386 in combination with other antiandrogens: apalutamide and abiraterone acetate (Janssen), enzalutamide (Astellas), and darolutamide (Bayer)[130](index=130&type=chunk) - A June 2022 clinical update on the Phase 1a study (36 patients) showed EPI-7386 was well-tolerated with a favorable safety profile and demonstrated initial anti-tumor activity (tumor volume decrease, PSA stabilization) in a subset of patients[136](index=136&type=chunk)[138](index=138&type=chunk)[141](index=141&type=chunk) - Preclinical data presented at AACR 2022 for the company's ANITAC™ NTD degraders demonstrated their potential to degrade multiple forms of the androgen receptor, including full-length, mutant, and splice variants, representing a new approach to AR pathway inhibition[131](index=131&type=chunk)[146](index=146&type=chunk) [Competition and Intellectual Property](index=49&type=section&id=Competition%20and%20Intellectual%20Property) ESSA competes in the prostate cancer market with a unique AR-NTD inhibitor mechanism, supported by a strong intellectual property portfolio of 58 issued patents, including 5 for EPI-7386 Currently Approved Competing Therapies | BRAND NAME | COMPANY NAME(S) | | :--- | :--- | | Xtandi | Astellas and Pfizer | | Zytiga | Johnson & Johnson | | Erleada | Johnson & Johnson | | Nubeqa | Bayer | | Keytruda | Merck | | Lynparza | AstraZeneca | | Rubraca | Clovis Oncology | - ESSA's competitive position is based on its unique mechanism of action, targeting the AR-NTD, which has the potential to bypass resistance pathways affecting current LBD-targeting therapies; to its knowledge, no other AR-NTD antagonist is in clinical trials[165](index=165&type=chunk) - As of July 2022, ESSA owns rights to **58 issued patents**, with five patents covering the EPI-7386 compound expected to provide protection lasting from **2036 to 2041**[173](index=173&type=chunk) [Results of Operations](index=61&type=section&id=Results%20of%20Operations) The company's comprehensive loss for the nine months ended June 30, 2022, increased slightly to $28.8 million, primarily due to higher R&D expenses for the EPI-7386 clinical trial R&D Expense Breakdown (Nine Months Ended June 30) | Expense Category | 2022 ($) | 2021 ($) | | :--- | :--- | :--- | | Clinical | $3,731,044 | $4,213,305 | | Preclinical and data analysis | $6,045,555 | $3,231,017 | | Manufacturing (CMC) | $3,970,564 | $5,516,377 | | Share-based payments | $3,253,741 | $2,323,185 | | Salaries and benefits | $1,516,507 | $1,209,060 | | **Total R&D Expense** | **$20,063,752** | **$17,985,937** | G&A Expense Breakdown (Nine Months Ended June 30) | Expense Category | 2022 ($) | 2021 ($) | | :--- | :--- | :--- | | Share-based payments | $2,700,703 | $4,329,428 | | Salaries and benefits | $3,021,159 | $2,567,566 | | Insurance | $1,448,983 | $698,158 | | Professional fees | $724,153 | $925,174 | | **Total G&A Expense** | **$9,775,082** | **$9,942,149** | - The increase in R&D expenses for the nine-month period was driven by ongoing activities for the EPI-7386 clinical trial, which commenced in July 2020, with preclinical and data analysis costs nearly doubling year-over-year[210](index=210&type=chunk)[212](index=212&type=chunk) [Liquidity and Capital Resources](index=67&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2022, ESSA maintains a strong liquidity position with $174.6 million in cash and investments, deemed sufficient to fund operations for over twelve months - As of June 30, 2022, the company had available cash reserves and short-term investments of **$174.6 million** and working capital of **$171.2 million**[227](index=227&type=chunk) - Management believes that its current capital is sufficient to fund operations and planned expenditures for more than twelve months from the reporting date[227](index=227&type=chunk) [Controls and Procedures](index=70&type=section&id=Item%203.%20Controls%20and%20Procedures) Management concluded that disclosure controls and internal control over financial reporting were effective as of June 30, 2022, with no material changes during the quarter - Based on an evaluation as of June 30, 2022, the CEO and CFO concluded that the company's disclosure controls and procedures were effective at the reasonable assurance level[240](index=240&type=chunk) - Management concluded that the company's internal control over financial reporting was effective as of June 30, 2022, based on the COSO 2013 framework[242](index=242&type=chunk) - There were no changes in internal control over financial reporting during the quarter ended June 30, 2022, that have materially affected, or are reasonably likely to materially affect, internal controls[243](index=243&type=chunk) [Part II: Other Information](index=71&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Summary of Other Information](index=71&type=section&id=Item%201.%20Legal%20Proceedings) The company reported no material legal proceedings, no material changes to risk factors, and no unregistered equity sales or senior security defaults as of June 30, 2022 - The company is not a party to any legal proceedings that would be reasonably expected to have a material adverse effect on its business[246](index=246&type=chunk) - There have been no material changes in risk factors from those disclosed in the company's 2021 Annual Report on Form 10-K[247](index=247&type=chunk) - The company reported no unregistered sales of equity securities during the quarter[248](index=248&type=chunk)

Financial Performance - Net loss for the period before taxes was $10,854,604 for the three months ended March 31, 2022, compared to a loss of $12,965,247 for the same period in 2021, indicating an improvement of about 16.3%[28] - Basic and diluted loss per common share improved from $(0.36) in Q1 2021 to $(0.25) in Q1 2022[28] - The company reported a comprehensive loss of $10,903,335 for the three months ended March 31, 2022, compared to a loss of $12,965,247 for the same period in 2021, indicating a reduction in losses[212] - ESSA's net losses for the six months ended March 31, 2022, were $20,001,254, compared to $19,493,951 for the same period in 2021, indicating ongoing financial challenges[195] Assets and Liabilities - Total assets decreased from $198,165,818 as of September 30, 2021, to $182,609,005 as of March 31, 2022, representing a decline of approximately 7.85%[22] - Total liabilities decreased from $4,160,266 as of September 30, 2021, to $3,894,071 as of March 31, 2022, a decrease of approximately 6.4%[22] - Shareholders' equity decreased from $194,005,552 as of September 30, 2021, to $178,714,934 as of March 31, 2022, a decline of approximately 7.8%[22] - Working capital as of March 31, 2022, was $178,353,354, down from $206,202,601 a year earlier[197] - Current liabilities stood at $3,748,803 as of March 31, 2022, a decrease from $3,929,663 on September 30, 2021[217] Cash Flow - Cash and cash equivalents decreased from $137,825,024 to $86,235,830, a reduction of about 37.4%[22] - Cash used in operating activities for the six months ended March 31, 2022, was $14,204,791, compared to $11,515,058 for the same period in 2021, an increase of about 23.3%[30] - Net cash used in investing activities for the six months ended March 31, 2022, was $37,625,805, compared to $35,003,478 for the same period in 2021, an increase of approximately 7.5%[30] - Available cash reserves and short-term investments were $181,018,439 as of March 31, 2022, compared to $194,927,183 on September 30, 2021[217] Research and Development - Research and development expenses for the three months ended March 31, 2022, were $7,649,459, compared to $7,268,257 for the same period in 2021, an increase of approximately 5.2%[28] - Research and development (R&D) expenses for the six months ended March 31, 2022, totaled $13,669,218, up from $11,754,029 in the same period of 2021, reflecting ongoing clinical trials[199] - The company recognized research and development expenses of $1,113,376 for the three months ended March 31, 2022, compared to $782,846 for the same period in 2021, reflecting a 42.3% increase[79] - The company has no products in commercial production or use as of March 31, 2022[35] Clinical Trials and Product Development - The company’s investigational compound EPI-7386 is designed to disrupt the androgen receptor signaling pathway, which is crucial for prostate cancer growth[94] - The company has completed a Phase I clinical trial of its first-generation agent, ralaniten acetate (EPI-506), which showed prostate-specific antigen declines, although not sufficient for clinical benefit[95] - The Phase I clinical trial of EPI-7386 began in June 2020, with the first patient dosed in July 2020, and is currently actively enrolling patients[114] - The Phase 1 part of the clinical trial evaluates safety and tolerability to establish recommended doses for EPI-7386 and enzalutamide[192] Intellectual Property and Collaborations - The Company has developed a strong intellectual property position with 48 issued patents, including 5 covering EPI-7386, expected to provide protection until 2036 to 2041[107] - The Company retains all commercial rights for its aniten series drug portfolio and is evaluating potential collaborations to enhance the value of its prostate cancer program[141] - The Company has initiated collaborations with Janssen, Astellas, and Bayer to evaluate EPI-7386 in combination with existing antiandrogens in clinical trials[116] Future Outlook and Financial Needs - The company believes it has sufficient capital to meet its obligations for more than twelve months[217] - Future cash requirements may vary due to costs associated with preclinical work and strategic opportunities[219] - The company may need to raise additional funds in the future through strategic collaborations or share issuances[219] - There is no assurance that the company will successfully raise funds to continue its operational activities[219]

NASDAQ: EPIX O P P E NHE IMER'S 3 2 n d A N N UAL H E A LT H CA RE C O N FERENC E M A RC H 1 5- 17, 2 0 22 Forward Looking Statements 2 Certain written statements in and/or oral statements made in connection with this presentation may be considered forward-looking statements within the meaning of applicable Canadian securities laws and the United States securities laws, that may not be based on historical fact, including, without limitation, statements containing the words "believe", "may", "plan", "will", ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended December 31, 2021 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-37410 ESSA Pharma Inc. (Exact name of registrant as specified in its charter) British Columbia, Canada 98- ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended September 30, 2021 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-37410 ESSA Pharma Inc. (Exact name of registrant as specified in its charter) British Columbia, Canada 47-2569713 (State or other j ...