ESSA Pharma (EPIX) - 2023 Q2 - Quarterly Report

Form 10-Q Filing Information 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] 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] Table of Contents 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] Cautionary Note Regarding Forward-Looking Statements 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] - 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] - A summary of material risk factors is provided, with a full discussion available in the Annual Report on Form 10-K[13] PART I. FINANCIAL INFORMATION Presents unaudited condensed consolidated interim financial statements and management's discussion and analysis Item 1. Financial Statements and Supplementary Data 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 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] - Total assets decreased by approximately $11 million, and total shareholders' equity decreased by approximately $10.78 million over the six-month period[28] Condensed Consolidated Interim Statements of Operations and Comprehensive Loss 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] - Interest and other income significantly increased to $2.27 million in 2023 from $0.56 million in 2022[30] Condensed Consolidated Interim Statements of Cash Flows 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] - 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] Condensed Consolidated Interim Statement of Changes in Shareholders' Equity 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] - Share-based payments contributed $3.0 million to additional paid-in capital during the six months ended March 31, 2023[33] Notes to Condensed Consolidated Interim Financial Statements Provides additional details and explanations for the figures presented in the financial statements Nature of Operations 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] Basis of Presentation 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][38][40] Recent Accounting Pronouncements 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][44] Short-Term Investments 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] 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] 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] Accounts Payable and Accrued Liabilities 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] Operating Lease 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] - 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] Shareholders' Equity 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][58] - 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][66] 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 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] Segmented Information 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] Financial Instruments and Risk 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] - The Company manages credit risk by placing cash with major financial institutions and maintaining an investment policy for short-term investments[72] - 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] - 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][76][77] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operation 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 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] - 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][85] - 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] Completed Phase 1 Clinical Study of EPI-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][91] - EPI-506 was generally well-tolerated, with PSA declines observed in some patients, predominantly at higher doses (≥1280 mg)[94][95] - 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] Next Generation Aniten Molecules 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] Our Strategy 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] The Identification and Characteristics of EPI-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][101] - An IND was submitted to the FDA on March 30, 2020, and clinical testing commenced in July 2020[102] Advancing EPI-7386 Through Clinical Development 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] - 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][108] - 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][110] Combination Studies – Developing a New Standard of Care for the Treatment of Prostate Cancer 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] - 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][114][119] - 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] Preclinical Development of Anitens, Degraders, and Other Indications 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][140] Recent Developments 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] - 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] - 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][123] Future Clinical Development Program 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][154] - 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] 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] 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] Patents and Proprietary Rights 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][163][164] - 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] Regulatory Environment 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] - 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] - 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][191] Orphan Designation and Exclusivity 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][195] Selected Quarterly Financial Information 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] Results of Operations for the Six Months Ended March 31, 2023 and 2022 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] 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][202][203] 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][207] Three Months Ended March 31, 2023 and 2022 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] - Research and development expenses decreased to $4.5 million (2023) from $7.6 million (2022), driven by lower clinical, preclinical, and manufacturing costs[211] - 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] Liquidity and Capital Resources 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] - The Company believes it has sufficient capital to satisfy its obligations and execute planned expenditures for more than twelve months[215] - Future cash requirements may necessitate raising additional funds through strategic collaborations, equity issuance, or other financing sources[216] Critical Accounting Policies and Estimates 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] Trend Information 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] Off-Balance Sheet Arrangement 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] Outstanding Share Data 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] Item 3. Quantitative and Qualitative Disclosure About Market Risk 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] Item 4. Controls and Procedures 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][228] - 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][230] - There were no material changes in internal control over financial reporting during the quarter ended March 31, 2023[231] PART II. OTHER INFORMATION Presents additional information not covered in the financial section, including legal and regulatory matters Item 1. Legal Proceedings 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] Item 1A. Risk Factors 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] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 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] Item 3. Defaults Upon Senior Securities Discloses any defaults upon senior securities - The Company reported no defaults upon senior securities for the period[236] Item 4. Mine Safety Disclosures Provides disclosures related to mine safety - This item is not applicable to the Company[237] Item 5. Other Information Includes any other information not covered by previous items - The Company reported no other information for the period[238] Item 6. Exhibits, Financial Statement Schedules 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] 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][245]