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 March 31, 2023 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 98-125 ...

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 ...

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 June 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 47-2569 ...

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 March 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 47-256 ...