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 fromto

Commission file number: 001-37410

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
Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Shares	EPIX	Nasdaq Capital Market

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
		Emerging growth company	☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Securities Exchange Act of 1934). Yes ☐ No ☒

The number of outstanding common shares of the registrant, no par value per share, as of May 9, 2023 was 44,092,374.

ESSA PHARMA INC.

QUARTERLY REPORT ON FORM 10-Q

For the Quarter Ended March 31, 2023

Table of Contents

	PART I. FINANCIAL INFORMATION	8
Item 1.	Financial Statements and Supplementary Data	8
	Condensed Consolidated Interim Balance Sheets as of March 31, 2023 and September 30, 2022	9
	Condensed Consolidated Interim Statements of Operations and Comprehensive Loss for the three and six months ended March 31, 2023 and 2022	10
	Condensed Consolidated Interim Statements of Cash Flows for the six months ended March 31, 2023 and 2022	11
	Condensed Consolidated Interim Statement of Changes in Shareholders’ Equity for the three and six months ended March 31, 2023 and 2022	12
	Notes to Condensed Consolidated Interim Financial Statements	13
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operation	22
Item 3.	Quantitative and Qualitative Disclosure About Market Risk	44
Item 4.	Controls and Procedures	44
	PART II. OTHER INFORMATION	45
Item 1.	Legal Proceedings	45
Item 1A.	Risk Factors	45
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	45
Item 3.	Defaults Upon Senior Securities	45
Item 4.	Mine Safety Disclosures	45
Item 5.	Other Information	45
Item 6.	Exhibits, Financial Statement Schedules	46
	SIGNATURES	47

2

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q includes “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and “forward-looking information” within the meaning of Canadian securities laws, or collectively, forward-looking statements. Forward-looking statements include statements that may relate to our plans, objectives, goals, strategies, future events, future revenue or performance, capital expenditures, financing needs and other information that is not historical information. Many of these statements appear, in particular, under the headings “Business,” “Risk Factors,” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations”. Forward-looking statements can often be identified by the use of terminology such as “subject to”, “believe,” “anticipate,” “plan,” “expect,” “intend,” “estimate,” “project,” “may,” “will,” “should,” “would,” “could,” “hope,” “can,” the negatives thereof, variations thereon and similar expressions, or by discussions of strategy. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements. Examples of such forward looking statements include, but are not limited to statements related to:

● our ability to maintain operations, development programs, preclinical studies, clinical trials and raise capital as a result of global macroeconomic factors including inflation, supply chain issues and any ongoing impact from the coronavirus disease 2019 outbreak (“COVID 19”);

● our ability to advance our product candidate and potential future product candidates through, and successfully complete, clinical trials;

● our ability to recruit sufficient numbers of patients for future clinical trials, and the benefits expected therefrom;

● our ability to establish and maintain relationships with collaborators with acceptable development, regulatory and commercialization expertise and the benefits to be derived from such collaborative efforts;

● our ability to obtain funding for operations, including research funding, and the timing and potential sources of such funding;

● the initiation, timing, cost, location, progress and success of, strategy and plans with respect to our research and development programs (including research programs and related milestones with regards to next-generation drug candidates and compounds), preclinical studies and clinical trials;

● the therapeutic benefits, properties, effectiveness, pharmacokinetic profile and safety of our product candidate and potential future product candidates, if any, including the expected benefits, properties, effectiveness, pharmacokinetic profile and safety of our next-generation Aniten compounds;

● our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others;

● developments relating to our competitors and our industry, including the success of competing therapies that are or may become available;

● our ability to achieve profitability;

● the grant (“CPRIT Grant”) under the Cancer Prevention and Research Institute of Texas (“CPRIT”) and payments thereunder, including any residual obligations;

● our intended use of proceeds from past and future offerings of our securities;

● the implementation of our business model and strategic plans, including strategic plans with respect to patent applications and strategic collaborations and partnerships;

● our ability to identify, develop and commercialize product candidates;

● our commercialization, marketing and manufacturing capabilities and strategy;

● our expectations regarding federal, state, provincial and foreign regulatory requirements, including our plans with respect to anticipated regulatory filings;

● whether we will receive, and the timing and costs of obtaining, regulatory approvals in the United States, Canada and other jurisdictions;

● the accuracy of our estimates of the size and characteristics of the markets that may be addressed by our product candidate and potential future product candidates, if any;

● the rate and degree of market acceptance and clinical utility of our potential future product candidates, if any;

3

● the timing of, and our ability and our collaborators’ ability, if any, to obtain and maintain regulatory approvals for our product candidate and potential future product candidates, if any;

● our expectations regarding market risk, including inflation, interest rate changes and foreign currency fluctuations;

● our ability to engage and retain the employees required to grow our business;

● the compensation that is expected to be paid to our employees;

● our future financial performance and projected expenditures; and

● estimates of our financial condition, expenses, future revenue, capital requirements and our need for additional financing and potential sources of capital and funding.

Such statements reflect our current views with respect to future events, are subject to risks and uncertainties and are necessarily based upon a number of estimates and assumptions that are inherently subject to significant medical, scientific, business, economic, competitive, political and social uncertainties and contingencies. Many factors could cause our actual results, performance or achievements to be materially different from any future results, performance, or achievements that may be expressed or implied by such forward-looking statements, including those described under “Risk Factors” in our Annual Report on Form 10-K. All forward-looking statements included in this Quarterly Report on Form 10-Q, are based upon our current expectations and various assumptions. Certain assumptions made in preparing the forward-looking statements include, but are not limited to:

● our ability to maintain operations as a result of any ongoing impact from the COVID-19 outbreak;

● our ability to conduct clinical studies involving our product candidate and to identify any future product candidates;

● our ability to obtain regulatory and other approvals to commence clinical trials involving any future product candidates;

● our ability to obtain positive results from research and development activities, including clinical trials;

● the availability of sufficient financing on reasonable terms;

● our ability to obtain required regulatory approvals;

● our ability to protect patents and proprietary rights;

● our ability to successfully out-license or sell future products, if any, and in-license and develop new products;

● the absence of material adverse changes in our industry or the global economy;

● our ability to attract and retain key personnel;

● our continued compliance with third party license terms and non-infringement of third-party intellectual property rights;

● our ability to maintain good business relationships with our strategic partners; and

● our ability to understand and predict market competition.

We believe there is a reasonable basis for our current expectations, views and assumptions, but they are inherently uncertain. We may not realize our expectations and our views and assumptions may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements.  In evaluating forward-looking statements, investors should specifically consider the following uncertainties and factors, among others (including those set forth under the heading “Risk Factors” in our Annual Report on Form 10-K), that could affect future performance and cause actual results to differ materially from those matters expressed in or implied by forward-looking statements

RISK FACTOR SUMMARY

Below is a summary of material factors that make an investment in our Common Shares (the “Common Shares”) speculative or risky. Importantly, this summary does not address all of the risks and uncertainties that we face. Additional discussion of the risks and uncertainties summarized in this risk factor summary, as well as other risks and uncertainties that we face, can be found under “Special Note Regarding Forward-Looking Statements” and Part I, Item 1A. “Risk Factors” in our Annual Report on Form 10-K. The below summary is qualified in its entirety by those more complete discussions of such risks and uncertainties. You should consider carefully the risks and uncertainties described under Part I, Item 1A. “Risk Factors” in our Annual Report on Form 10-K as part of your evaluation of an investment in our Common Shares. Important factors that could cause such differences include, among other things, the following:

4

● risks related to our ability to maintain operations and execute on our business plan as a result of global macroeconomic factors including inflation, supply chain issues and the COVID-19 outbreak or other health epidemics;

● risks related to clinical trial development and our ability to conduct the clinical trial of our product candidate and the predictive value of our current or planned clinical trials;

● risks related to clinical trials being conducted by third parties under collaboration and clinical supply agreements, including combination studies, using the Company’s product candidate, studies which the Company may not control, and ensuing reputational risk related to clinical trial results;

● risks related to our future success being dependent primarily on identification through preclinical studies, clinical studies, regulatory approval for commercialization of a single product candidate;

● risks related to our license agreement with third parties;

● uncertainty related to our ability to obtain required regulatory approvals for our proposed products;

● risks related to the Company’s ability to conduct a clinical trial or submit a future NDA/NDS or IND/CTA (each, as defined herein);

● risks related to our ability to successfully commercialize future product candidates;

● risks related to the possibility that our product candidate and potential future product candidates, if any, may have undesirable side effects when used alone or in combination with other drugs;

● risks related to our ability to enroll subjects in clinical trials;

● risks that the FDA may not accept data from trials conducted in locations outside the United States;

● risks related to our ongoing obligations and continued regulatory review;

● risks related to potential administrative or judicial sanctions;

● the risk of increased costs associated with prolonged, delayed or terminated clinical trials;

● the risk that third parties may not carry out their contractual duties or terminate the relationship;

● risks related to our lack of experience manufacturing product candidates on a large clinical or commercial scale and our lack of manufacturing facility;

● risks inherent in foreign operations, including related to foreign sourced raw materials, manufacturing or clinical trials;

● risks related to disruptions in domestic and foreign supply chains that the Company relies on for the production and shipment of raw materials and clinical trial materials;

● risks related to our failure to obtain regulatory approval in international jurisdictions;

● risks related to recently enacted and future legislation in the United States and internationally that may increase the difficulty and cost for us to obtain marketing approval of, and commercialize, our product candidate and potential future products, if any, and affect the prices we may obtain;

● risks related to new legislation, new regulatory requirements, and the continuing efforts of governmental and third-party payors to contain or reduce the costs of healthcare;

● uncertainty as to our ability to raise additional funding;

● risks related to our ability to raise additional capital on favorable terms and the impact of dilution from incremental financing;

● risks of a deemed default on any residual obligations of the agreement providing for the CPRIT Grant and having to reimburse all of the CPRIT Grant, if such deemed default is not waived by CPRIT;

● risks related to our incurrence of significant losses in every quarter since inception and our anticipation that it will continue to incur significant losses in the future;

● risks related to our limited operating history;

● risks related to our reliance on proprietary technology;

● risks related to our ability to protect our intellectual property rights throughout the world;

● risks related to claims by third parties asserting that we, or our employees, contractors or consultants have misappropriated their intellectual property, or claiming ownership of what we regard as our intellectual property;

● risks related to our ability to comply with governmental patent agency requirements in order to maintain patent protection;

● risks related to computer system failures or security breaches and increasing cyber threats;

5

● risks related to business disruptions that could seriously harm our future revenues and financial condition and increase our costs and expenses;

● risks related to our ability to attract and maintain highly qualified personnel;

● risks relating to the possibility that third-party coverage and reimbursement and health care cost containment initiatives and treatment guidelines may constrain our future revenues;

● risks related to potential conflicts of interest between us and our directors and officers;

● risks related to competition from other biotechnology and pharmaceutical companies;

● risks related to movements in foreign currency exchange rates, interest rates and rate of inflation;

● risks related to our ability to convince public payors and hospitals to include our product candidate and potential future products, if any, on their approved formulary lists;

● risks related to our ability to establish an effective sales force and marketing infrastructure, or enter into acceptable third-party sales and marketing or licensing arrangements;

● risks related to our ability to manage growth;

● risks related to our ability to achieve or maintain expected levels of market acceptance for our products;

● risks related to our ability to realize benefits from acquired businesses or products or form strategic alliances in the future;

● risks related to collaborations with third parties;

● risks that employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could cause significant liability for us and harm our reputation;

● risks related to product liability lawsuits;

● risks related to compulsory licensing and/or generic competition;

● risks related to being a smaller reporting company;

● risks related to share price volatility in the event there is low liquidity for the trading of the Company’s Common Shares;

● risks related to the possibility that laws and regulations governing international operations may preclude us from developing, manufacturing and selling certain product candidates outside of the United States and Canada and require us to develop and implement costly compliance programs;

● risks related to laws that govern fraud and abuse and patients’ rights;

● risks related to our ability to comply with environmental, health and safety laws and regulations;

● risks related to us being a “passive foreign investment company”;

● risks related to United States investors’ ability to effect service of process or enforcement of actions against us;

● risks related to market price and trading volume volatility;

● risks related to our dividend policy;

● risks associated with future sales of our securities;

● risks related to our ability to maintain an active trading market for the Company's Common Shares;

● risks related to our ability to implement and maintain effective internal controls;

● risks related to provisions in our charter documents and Canadian law affecting corporate governance; and

● risks related to analyst coverage.

If one or more of these risks or uncertainties or a risk that is not currently known to us, materialize, or if our underlying assumptions prove to be incorrect, actual results may vary materially from those expressed or implied by forward-looking statements. The forward-looking statements represent our expectations, plans, estimates and views as of the date of this document. We do not undertake and specifically decline any obligation to update, republish or revise forward-looking statements to reflect future events or circumstances or to reflect the occurrences of unanticipated events, except as required by law. Investors are cautioned that we cannot guarantee future results, events, levels of activity, performance or achievements and that forward-looking statements are inherently uncertain. Accordingly, investors are cautioned not to put undue reliance on forward-looking statements. We advise you that these cautionary remarks expressly qualify in their entirely all forward-looking statements attributable to us or persons acting on our behalf.

6

We express all amounts in this Quarterly Report on Form 10-Q in U.S. dollars, except where otherwise indicated. References to “$” and “US$” are to U.S. dollars and references to “C$” are to Canadian dollars. Except as otherwise indicated, references in this Quarterly Report on Form 10-Q to “ESSA,” “the Company,” “we,” “us” and “our” refer to ESSA Pharma Inc. and its subsidiaries.

7

PART I. FINANCIAL INFORMATION

Item 1.     Financial Statements and Supplementary Data

ESSA Pharma Inc.

CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(Unaudited)

(Expressed in United States dollars)

FOR THE THREE AND SIX MONTHS ENDED MARCH 31, 2023

8

ESSA PHARMA INC.

CONDENSED CONSOLIDATED INTERIM BALANCE SHEETS

(Unaudited)

(Expressed in United States dollars)

AS OF

		March 31,		September 30,
	2023		2022
ASSETS
Current
Cash and cash equivalents	$	44,300,677	$	57,076,475
Short-term investments (Note 4)		112,743,037		110,161,029
Receivables		8,783		6,211
Prepaids (Note 5)		1,061,353		1,815,626
		158,113,850		169,059,341
Deposits		264,585		259,455
Operating lease right-of-use assets (Note 7)		125,605		186,499
Total assets	$	158,504,040	$	169,505,295
LIABILITIES AND SHAREHOLDERS’ EQUITY
Current
Accounts payable and accrued liabilities (Note 6)	$	2,021,113	$	2,176,565
Current portion of operating lease liabilities (Note 7)		125,491		133,834
		2,146,604		2,310,399
Operating lease liabilities (Note 7)		19,777		76,418
Total liabilities		2,166,381		2,386,817
Shareholders’ equity
Authorized
Unlimited common shares, without par value
Unlimited preferred shares, without par value
Common shares 44,092,374 issued and outstanding (September 30, 2022 – 44,073,076) (Note 8)		278,141,528		278,089,136
Additional paid-in capital (Note 8)		47,042,101		44,043,503
Accumulated other comprehensive loss		(2,164,833)		(2,135,145)
Accumulated deficit		(166,681,137)		(152,879,016)
		156,337,659		167,118,478
Total liabilities and shareholders’ equity	$	158,504,040	$	169,505,295

Nature of operations (Note 1)

The accompanying notes are an integral part of these condensed consolidated interim financial statements.

9

ESSA PHARMA INC.

CONDENSED CONSOLIDATED INTERIM STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(Unaudited)

(Expressed in United States dollars)

	For the three months ended				For the six months ended
	March 31,				March 31,
	2023		2022		2023		2022
OPERATING EXPENSES
Research and development	$	4,480,863	$	7,649,459	$	9,825,113	$	13,669,218
Financing costs (Note 7)		1,944		3,526		4,294		7,851
General and administration		3,730,692		3,817,370		6,249,811		6,879,540
Total operating expenses		(8,213,499)		(11,470,355)		(16,079,218)		(20,556,609)
Foreign exchange		(762)		16,259		10,771		29,428
Interest and other income		1,155,622		481,751		2,267,926		556,335
Derivative liability gain		—		117,741		—		18,423
Loss for the period before taxes		(7,058,639)		(10,854,604)		(13,800,521)		(19,952,423)
Income tax expense		(1,600)		—		(1,600)		(100)
Net loss for the period		(7,060,239)		(10,854,604)		(13,802,121)		(19,952,523)
OTHER COMPREHENSIVE LOSS
Unrealized loss on short-term investments (Note 4)		(59,115)		(48,731)		(29,688)		(48,731)
Loss and comprehensive loss for the period	$	(7,119,354)	$	(10,903,335)	$	(13,831,809)	$	(20,001,254)
Basic and diluted loss per common share	$	(0.16)	$	(0.25)	$	(0.31)	$	(0.45)
Weighted average number of common shares outstanding – basic and diluted		44,092,374		44,030,480		44,082,725		44,009,903

The accompanying notes are an integral part of these condensed consolidated interim financial statements.

10

ESSA PHARMA INC.

CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS

(Unaudited)

(Expressed in United States dollars)

FOR THE SIX MONTHS ENDED MARCH 31,

	2023		2022
CASH FLOWS FROM OPERATING ACTIVITIES
Loss for the period	$	(13,802,121)	$	(19,952,523)
Items not affecting cash and cash equivalents:
Amortization of right-of-use asset		60,894		60,893
Amortization/(Accretion) of premiums/discounts on short-term investments, net		(279,405)		65,060
Accretion of lease liability		4,294		7,410
Derivative liability gain		—		(18,423)
Interest income		(1,542,218)		(157,464)
Unrealized foreign exchange		111		19,520
Share-based payments		3,000,699		4,363,444
Changes in non-cash working capital items:
Receivables		(2,572)		476,062
Prepaids		749,143		1,117,418
Accounts payable and accrued liabilities		(157,759)		(186,188)
Net cash used in operating activities		(11,968,934)		(14,204,791)
CASH FLOWS FROM INVESTING ACTIVITIES
Purchase of short-term investments		(178,310,466)		(104,817,397)
Proceeds from short-term investments sold		175,939,115		67,028,803
Interest from short-term investments		1,581,278		162,789
Net cash used in investing activities		(790,073)		(37,625,805)
CASH FLOWS FROM FINANCING ACTIVITIES
Options exercised		—		319,832
Shares purchased through employee share purchase plan		50,291		27,360
Lease payments		(69,278)		(64,746)
Net cash provided by financing activities		(18,987)		282,446
Effect of foreign exchange on cash and cash equivalents		2,196		(41,044)
Change in cash and cash equivalents for the period		(12,775,798)		(51,589,194)
Cash and cash equivalents, beginning of period		57,076,475		137,825,024
Cash and cash equivalents, end of period	$	44,300,677	$	86,235,830

The accompanying notes are an integral part of these condensed consolidated interim financial statements.

11

ESSA PHARMA INC.

CONDENSED CONSOLIDATED INTERIM STATEMENT OF CHANGES IN SHAREHOLDERS’ EQUITY

(Unaudited)

(Expressed in United States dollars)

FOR THE THREE AND SIX MONTHS ENDED MARCH 31, 2023 AND 2022

						Accumulated
				Additional		other
	Number	Common		paid-in		comprehensive
	of shares	shares		capital		loss		Deficit		Total
Balance, September 30, 2021	43,984,346	$	277,415,176	$	36,442,620	$	(2,076,479)	$	(117,775,765)	$	194,005,552
Options exercised	29,080		184,512		(80,188)		—		—		104,324
Shares issued through employee share purchase plan	2,444		45,936		(18,576)		—		—		27,360
Share-based payments	—		—		2,500,091		—		—		2,500,091
Loss for the period	—		—		—		—		(9,097,919)		(9,097,919)
Balance, December 31, 2021	44,015,870	$	277,645,624	$	38,843,947	$	(2,076,479)	$	(126,873,684)	$	187,539,408
Options exercised	43,830		384,342		(168,834)		—		—		215,508
Share-based payments	—		—		1,863,353		—		—		1,863,353
Loss for the period	—		—		—		(48,731)		(10,854,604)		(10,903,335)
Balance, March 31, 2022	44,059,700	$	278,029,966	$	40,538,466	$	(2,125,210)	$	(137,728,288)	$	178,714,934
						Accumulated
				Additional		other
	Number	Common		paid-in		comprehensive
	of shares	shares		capital		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 employee share purchase plan	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

The accompanying notes are an integral part of these condensed consolidated interim financial statements.

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ESSA PHARMA INC.

NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

(Unaudited)

(Expressed in United States dollars)

FOR THE SIX MONTHS ENDED MARCH 31, 2023

1.     NATURE OF OPERATIONS

Nature of Operations

The Company was incorporated under the laws of the Province of British Columbia on January 6, 2009. The Company’s head office address is Suite 720 – 999 West Broadway, Vancouver, BC, V5Z 1K5. The registered and records office address is the 26^th Floor at 595 Burrard Street, Three Bentall Centre, Vancouver, BC, V7X 1L3. The Company is listed on the Nasdaq Capital Market (“Nasdaq”) under the symbol “EPIX”.

The Company is focused on the development of small molecule drugs for the treatment of prostate cancer. The Company has acquired a license to certain patents (“NTD”) which were the joint property of the British Columbia Cancer Agency and the University of British Columbia. As of March 31, 2023, no products are in commercial production or use.

2.     BASIS OF PRESENTATION

Basis of Presentation

These accompanying unaudited condensed consolidated interim financial statements, including comparatives, have been prepared in accordance with United States’ Generally Accepted Accounting Principles (“U.S. GAAP”) and pursuant to the rules and regulations of the United States Securities and Exchange Commission (“SEC”) for interim financial information. Accordingly, these condensed consolidated interim financial statements do not include all of the information and footnotes required for complete consolidated financial statements and should be read in conjunction with the audited consolidated financial statements and notes for the year ended September 30, 2022 and included in the Company’s 2022 Annual Report on Form 10-K filed with the SEC and with the securities commissions in British Columbia, Alberta and Ontario on December 13, 2022.
​

These unaudited condensed consolidated interim financial statements reflect all adjustments, consisting of normal recurring adjustments, which, in the opinion of management, are necessary for a fair presentation of results for the interim periods presented. The results of operations for the six months ended March 31, 2023 and 2022 are not necessarily indicative of results that can be expected for a full year. These unaudited condensed consolidated interim financial statements follow the same significant accounting policies as those described in the notes to the audited consolidated financial statements of the Company included in the Company’s 2022 Annual Report on Form 10-K for the year ended September 30, 2022, with the exception of any policies described in Note 3.

These accompanying unaudited condensed consolidated interim financial statements include the accounts of the Company and its wholly owned subsidiaries. Inter-company transactions, balances and unrealized gains or losses on transactions are eliminated upon consolidation.

The accompanying condensed consolidated interim financial statements have been prepared on a historical cost basis except for certain financial assets measured at fair value.

All amounts expressed in these accompanying condensed consolidated interim financial statements and the accompanying notes are expressed in United States dollars, except per share data and where otherwise indicated. References to “$” are to United States dollars and references to “C$” are to Canadian dollars.

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Use of Estimates

The preparation of the accompanying condensed consolidated interim financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions about future events that affect the reported amounts of assets, liabilities, expenses, contingent assets and contingent liabilities as of the end of, or during, the reporting period. Actual results could significantly differ from those estimates. Significant areas requiring management to make estimates include the valuation of equity instruments issued for services. Further details of the nature of these assumptions and conditions may be found in the relevant notes to these condensed consolidated interim financial statements.

The effect of a change in an accounting estimate is recognized prospectively by including it in comprehensive income in the period of the change, if the change affects that period only, or in the period of the change and future periods, if the change affects both. Estimates and assumptions are reviewed quarterly.

3.     RECENT ACCOUNTING PRONOUNCEMENTS

Recent accounting pronouncements not yet adopted

Management does not believe that any recently issued, but not yet effective, accounting standards, if currently adopted, would have a material effect on the Company’s condensed consolidated interim financial statements.

Recent accounting pronouncements issued by the FASB, including its Emerging Issues Task Force, the American Institute of Certified Public Accountants, and the Securities and Exchange Commission did not or are  not believed by management to have a material impact on the Company’s present or future consolidated financial statement presentation or disclosures.

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4.     SHORT-TERM INVESTMENTS

Short-term investments consist of guaranteed investment certificates (“GICs”) held at financial institutions purchased in accordance with the Company’s treasury policy. These GICs and term deposits bear interest at 4.30%-4.85% per annum and have maturities of up to 12 months.

Short-term investments also consist of U.S. treasury securities, corporate debt securities and commercial paper. The Company has classified these investments as available-for-sale, as the sale of such investments may be required prior to maturity to implement management strategies, and therefore has classified all investment securities as current assets. Those investments with maturity dates of three months or less at the date of purchase are presented as cash equivalents in the accompanying balance sheets. Short-term investments are carried at fair value with the unrealized gains and losses included in accumulated other comprehensive loss as a component of shareholders’ equity (deficit) until realized. Any premium or discount arising at purchase is amortized or accreted to interest income as an adjustment to yield using the straight-line method over the life of the instrument. The Company records an allowance for credit losses when unrealized losses are due to credit-related factors. Realized gains and losses are calculated using the specific identification method and recorded as interest income.

		As of March 31, 2023
		Amortized	Unrealized					Accrued		Estimated
		Cost		Gains		Losses		Interest		Fair Value
GICs and Term deposits	$	40,043,353	$	—	$	—	$	279,493	$	40,322,846
U.S. Treasury securities		71,334,448		—		(84,966)		105,093		71,354,575
Corporate debt securities		1,068,360		—		(3,388)		644		1,065,616
Balance, end of period	$	112,446,161	$	—	$	(88,354)	$	385,230	$	112,743,037
		As of September 30, 2022
		Amortized	Unrealized					Accrued		Estimated
		Cost		Gains		Losses		Interest		Fair Value
GICs and Term deposits	$	89,688,690	$	—	$	—	$	316,960	$	90,005,650
U.S. Treasury securities		11,149,053		—		(39,590)		39,720		11,149,183
Corporate debt securities		3,034,417		—		(19,076)		29,258		3,044,599
Commercial paper		5,961,597		—		—		—		5,961,597
Balance, end of period	$	109,833,757	$	—	$	(58,666)	$	385,938	$	110,161,029

As of March 31, 2023, short-term investments have an aggregate fair market value of $112.7 million (September 30, 2022 – $110.2 million) were in an aggregate gross unrealized loss position of $88,354 (September 30, 2022 - $58,666). The Company considers the decline in market value for the securities to be primarily attributable to current economic and market conditions. These particular investments have been in an unrealized loss position for less than 12 months and it is not more likely than not that the Company will be required to sell any of its securities prior to maturity. Accordingly, no allowance for credit losses has been recorded as of March 31, 2023 and no realized gains or losses on sales of short-term investments have been recorded through March 31, 2023.

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5.     PREPAIDS

		March 31,		September 30,
	2023		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

6.     ACCOUNTS PAYABLE AND ACCRUED LIABILITIES

		March 31,		September 30,
	2023		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

7.     OPERATING LEASE

Operating lease right-of-use assets
Balance, September 30, 2021	$	308,286
Amortization		(60,893)
Balance, March 31, 2022	$	247,393
Balance, September 30, 2022	$	186,499
Amortization		(60,894)
Balance, March 31, 2023	$	125,605
Operating lease liabilities
Balance, September 30, 2021	$	330,970
Accretion		7,410
Lease payments		(64,746)
Balance, March 31, 2022	$	273,634
Balance, September 30, 2022	$	210,252
Accretion		4,294
Lease payments		(69,278)
Balance, March 31, 2023	$	145,268
Operating lease liabilities with expected life of less than one year	$	125,491
Operating lease liabilities with expected life greater than one year	$	19,777

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The Company recognizes a right-of-use asset for the right to use the underlying asset for the lease term, and a lease liability, which represents the present value of the Company’s obligation to make payments over the lease term. The present value of the lease payments is calculated using an incremental borrowing rate as the Company’s leases do not provide an implicit interest rate. At March 31, 2023, the Company’s incremental borrowing rate was 5.0% and the remaining lease term for the South San Francisco office was 14 months and Houston office was 4 months.

Accretion expense of $4,294 (2022 - $7,410) has been recorded in “financing costs” in the condensed consolidated interim statements of operations and comprehensive loss.

8.     SHAREHOLDERS’ EQUITY

Authorized

Unlimited common shares, without par value.

Unlimited preferred shares, without par value.

Omnibus incentive plans

The Company has adopted an omnibus incentive plan  (“Omnibus Plan”) consistent with the policies and rules of the Nasdaq.  Pursuant to the Omnibus Plan, the Company may issue stock options, share appreciation rights, restricted shares, restricted share units and other share-based awards. As of March 31, 2023, the Company has not issued any instruments other than stock options under the Omnibus Plan.

As of March 31, 2023, the Omnibus Plan has a maximum of 8,410,907 common shares which may be reserved for issuance.

Employee Share Purchase Plan

The Company has adopted an Employee Share Purchase Plan (“ESPP”) under which qualifying employees may be granted purchase rights (“Purchase Rights”) to the Company’s common shares at not less of 85% of the market price at the lesser of the date the Purchase Right is granted or exercisable. The Company currently holds offerings consisting of six month periods commencing on January 1 and July 1 of each calendar year, with a single purchase date at the end of the purchase period on June 30 and December 31 of each calendar year. As of March 31, 2023, the ESPP has a maximum of 217,300 (2022 – 249,974) common shares reserved for issuance.

Eligible employees are able to contribute up to 15% of their gross base earnings for purchases under the ESPP through regular payroll deductions. Purchase of shares under the ESPP are limited for each employee at $25,000 worth of the Company’s common shares (determined using the lesser of (i) the market price of a common share on the first day of an applicable purchase period and (ii) the market price of a common share on the purchase date) for each calendar year in which a purchase right is outstanding.

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During the six months ended March 31, 2023, the Company issued 19,298 shares (2022 – 2,444) upon the exercise of Purchase Rights. The Company recognizes compensation expense for purchase rights on a straight-line basis over the service period.

	For the three months ended				For the six months ended
	March 31,				March 31,
	2023			2022	2023			2022
Research and development expense	$	754	$	8,483	$	1,352	$	12,133
General and administrative		41		805		494		6,957
	$	795	$	9,288	$	1,846	$	19,090

The Company measures the purchase rights based on their estimated grant date fair value using the Black-Scholes option pricing model and the estimated number of shares that can be purchased. The following weighted average assumptions were used for the valuation of purchase rights:

	2023		2022
Risk-free interest rate	3.19	%	0.44	%
Expected life of share purchase rights	6 months		6 months
Expected annualized volatility	103.56	%	87.90	%
Dividend	—		—

Stock options

Pursuant to the Omnibus Plan, options may be granted with expiry terms of up to 10 years, and vesting criteria and periods are approved by the Board of Directors at its discretion. The options issued under the Stock Option Plan are accounted for as equity-settled share-based payments.

Stock option transactions are summarized as follows:

		Weighted
	Number	Average
	of Options	Exercise Price*
Balance, September 30, 2021	6,803,230	$	5.20
Options granted	1,347,500		4.55
Options exercised	(72,910)		(4.41)
Options expired/forfeited	(175,759)		(3.60)
Balance, September 30, 2022	7,902,061	$	5.13
Options granted	195,000		3.00
Options expired/forfeited	(51,787)		(5.03)
Balance outstanding, March 31, 2023	8,045,274	$	5.08
Balance exercisable, March 31, 2023	5,302,472	$	4.83

* Options exercisable in Canadian dollars as of March 31, 2023 are translated at current rates to reflect the current weighted average exercise price in US dollars for all outstanding options.

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At December 31, 2022, options were outstanding enabling holders to acquire common shares as follows:

			Weighted average remaining
	Exercise price	Number of options	contractual life (years)
$	2.39	50,000	9.46
$	2.91	175,000	9.83
$	3.23	3,629,400	6.52
$	3.59	26,667	6.55
$	3.60	922,500	9.25
$	3.75	20,000	9.68
$	3.81	185,816	5.87
$	4.00	539,518	4.73
$	4.67	168,227	6.59
$	5.99	190,000	9.07
$	7.00	1,458,646	7.70
$	8.47	120,000	8.54
$	9.76	50,000	8.89
$	13.96	190,000	7.79
$	29.63	100,000	8.08
$	31.62	75,000	8.17
C$	4.90	124,500	4.13
C$	5.06	20,000	5.87
		8,045,274	7.15

Share-based compensation

During the six months ended March 31, 2023, the Company granted a total of 195,000 (2022 – 170,000) stock options with a weighted average fair value of $2.76 per option (2022 - $7.34).

The Company recognized share-based payments expense for options granted and vesting, net of recoveries on cancellations of unvested options, during the period ended March 31, 2023 and 2022 with allocations to its functional expense as follows:

For the three months ended For the six months ended