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Essa Pharma (EPIX)

ESSA is a clinical-stage pharmaceutical company focused on developing novel and proprietary therapies for the treatment of patients with prostate cancer.

Company profile

Ticker
EPIX
Exchange
CEO
David R. Parkinson
Employees
Fiscal year end
SEC CIK
Subsidiaries
ESSA Pharmaceuticals Corp. • Realm Therapeutics, plc • Realm Therapeutics, Inc. ...

EPIX stock data

Investment data

Data from SEC filings
Securities sold
Number of investors

Calendar

4 Aug 22
15 Aug 22
30 Sep 22
Quarter (USD) Jun 22 Mar 22 Dec 21 Sep 21
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS
Annual (USD) Sep 21 Sep 20 Sep 19 Sep 18
Revenue
Cost of revenue
Operating income
Operating margin
Net income
Net profit margin
Cash on hand
Change in cash
Diluted EPS
Cash burn rate (est.) Burn method: Change in cash Burn method: Operating income Burn method: FCF (opex + capex)
Last Q Avg 4Q Last Q Avg 4Q Last Q Avg 4Q
Cash on hand (at last report) 67.87M 67.87M 67.87M 67.87M 67.87M 67.87M
Cash burn (monthly) 6.12M 6.44M 2.96M 3.12M 2.21M 2.35M
Cash used (since last report) 9.35M 9.84M 4.52M 4.76M 3.38M 3.59M
Cash remaining 58.52M 58.03M 63.35M 63.11M 64.49M 64.28M
Runway (months of cash) 9.6 9.0 21.4 20.3 29.1 27.3

Beta Read what these cash burn values mean

Date Owner Security Transaction Code Indirect 10b5-1 $Price #Shares $Value #Remaining
18 Jul 22 Growth N V Biotech Common Shares Buy Acquire P No No 3.1558 300,000 946.74K 5,879,583
15 Jul 22 Growth N V Biotech Common Shares Buy Acquire P No No 3.1316 241,665 756.8K 5,579,583
14 Jul 22 Growth N V Biotech Common Shares Buy Acquire P No No 2.7921 347,204 969.43K 5,337,918
30 Jun 22 Parkinson David Ross Common Shares Buy Acquire P No No 2.958 4,887 14.46K 32,108
27 Apr 22 Growth N V Biotech Common Shares Sell Dispose S No No 5.8536 25,100 146.93K 4,990,714
13F holders Current Prev Q Change
Total holders 77 65 +18.5%
Opened positions 20 7 +185.7%
Closed positions 8 20 -60.0%
Increased positions 22 27 -18.5%
Reduced positions 14 20 -30.0%
13F shares Current Prev Q Change
Total value 526.52M 693.58M -24.1%
Total shares 55.53M 53.48M +3.8%
Total puts 0 0
Total calls 21.6K 11.4K +89.5%
Total put/call ratio
Largest owners Shares Value Change
BLVGF Bellevue 5.03M $31.12M 0.0%
BBBOF BB Biotech 5.02M $71.23M 0.0%
Biotechnology Value Fund L P 4.57M $0 0.0%
Soleus Capital Management 4.22M $26.1M +19.8%
Eventide Asset Managment 4.17M $25.77M +25.7%
BVF 3.7M $22.84M +29.6%
Soleus Capital 3.53M $50.06M 0.0%
JHG Janus Henderson 3.47M $21.47M +2.0%
RTW Investments 2.64M $16.3M 0.0%
Avidity Partners Management 2.46M $15.2M 0.0%
Largest transactions Shares Bought/sold Change
Clarus Lifesciences III 2.19M +2.19M NEW
MS Morgan Stanley 1.55M +1.55M +30707.3%
BX Blackstone 2M -1.3M -39.4%
Logos Global Management 0 -865K EXIT
Eventide Asset Managment 4.17M +851.61K +25.7%
BVF 3.7M +844.17K +29.6%
Vivo Capital 0 -744.06K EXIT
Soleus Capital Management 4.22M +698.34K +19.8%
Frazier Life Sciences Management 692.91K +692.91K NEW
FMR 0 -597.65K EXIT

Financial report summary

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Risks
  • Risks Relating to COVID-19
  • ESSA’s Product Candidate and Regulatory Matters
  • Clinical drug development involves a lengthy and expensive process with an uncertain outcome, results of earlier studies and trials may not be predictive of future trial results and ESSA’s product candidate and potential future product candidates may not have favorable results in later trials or in the commercial setting or satisfy the requirements of the FDA or non-US regulatory authorities.
  • ESSA’s future success is dependent primarily on the regulatory approval for commercialization of a single product candidate, which is in the clinical development stage.
  • If the Company breaches any of the agreements under which the Company licenses rights to its technology from third parties, the Company could lose license rights that are important to ESSA’s business. ESSA’s current license agreement may not provide an adequate remedy for its breach by the licensor.
  • The Company may not be able to obtain required regulatory approvals for the Company’s proposed products.
  • As an organization, ESSA has never submitted an NDA/NDS and may be unable to do so for any future products ESSA develops.
  • ESSA may not be able to successfully commercialize its Aniten series of compounds.
  • The Company’s product candidate and potential future product candidates may have undesirable side effects that may delay or prevent marketing approval or, if approval is received, require them to be taken off the market, require them to include safety warnings or otherwise limit their sales.
  • If ESSA is unable to enroll subjects in clinical trials, ESSA will be unable to complete these trials on a timely basis.
  • ESSA may conduct trials for future product candidates at sites outside the United States and the FDA may not accept data from trials conducted in such locations.
  • Even if the Company obtains marketing approval for any product candidate and potential future products, the Company will be subject to ongoing obligations and continued regulatory review, which may result in significant additional expense.
  • Failure to comply with applicable legal and regulatory requirements may result in administrative or judicial sanctions.
  • If clinical trials for ESSA’s product candidate and potential future product candidates are prolonged, delayed or stopped, ESSA may be unable to obtain regulatory approval and commercialize such product candidates on a timely basis, or at all, which would require ESSA to incur additional costs and delay receipt of any product revenue.
  • If ESSA’s relationships with CROs or academic institutions terminate, its drug development efforts could be delayed.
  • ESSA has limited experience manufacturing product candidates on a large clinical or commercial scale and has no manufacturing facility. As a result, ESSA may in the future be dependent on third party manufacturers for the manufacture of product candidates as well as on third parties for ESSA’s supply chain, and if ESSA experiences problems with any future third parties, the manufacturing of ESSA’s product candidates or products could be delayed.
  • Failure to obtain regulatory approval in international jurisdictions would prevent any product candidates from being marketed outside the United States.
  • Recently enacted and future legislation in the United States may increase the difficulty and cost for the Company to obtain marketing approval of, and commercialize, its products and affect the prices the Company may obtain.
  • ESSA’s business may be materially adversely affected by new legislation, new regulatory requirements and the continuing efforts of governmental and third-party payors to contain or reduce the costs of healthcare through various means.
  • Risks Related to ESSA’s Financial Position and Need for Additional Capital
  • ESSA will have significant additional future capital needs for future clinical trials and there are uncertainties as to the Company’s ability to raise additional funding.
  • ESSA may not be able to raise additional capital on favorable terms, which may result in dilution to ESSA’s existing shareholders, restrictions on ESSA’s operations or the requirement for ESSA to relinquish rights to technologies or any future product candidates.
  • The Company has incurred significant losses in every quarter since its inception and anticipates that it will continue to incur significant losses in the future and may never generate profits from operations or maintain profitability.
  • ESSA has a limited operating history, which may make it difficult for you to evaluate the success of ESSA’s business to date and to assess ESSA’s future viability.
  • ESSA relies on proprietary technology, the protection of which can be unpredictable and costly.
  • ESSA may not be able to protect its intellectual property rights throughout the world.
  • ESSA may be subject to claims by third parties asserting that ESSA, or ESSA’s employees or consultants have misappropriated their intellectual property, or claiming ownership of what ESSA regards as its own intellectual property.
  • Obtaining and maintaining ESSA’s patent protection depends on compliance with various procedural, document submissions, fee payment and other requirements imposed by governmental patent agencies, and its patent protection could be reduced or eliminated for non-compliance with these requirements.
  • Risks Related to ESSA’s Business and Industry
  • The Company’s business and operations would suffer in the event of computer system failures or security breaches.
  • Business disruptions could seriously harm ESSA’s future revenues and financial condition and increase costs and expenses.
  • ESSA’s business depends heavily on the use of information technologies.
  • If the Company is not successful in attracting and retaining highly qualified personnel, the Company may not be able to successfully implement its business strategy.
  • Third-party coverage and reimbursement and health care cost containment initiatives and treatment guidelines may constrain the Company’s future revenues.
  • The directors and officers of ESSA may be subject to conflicts of interest.
  • The Company faces intense competition from other biotechnology and pharmaceutical companies and its operating results will suffer if the Company fails to compete effectively.
  • The Company may face exposure to adverse movements in foreign currency exchange rates.
  • If ESSA is not able to convince public payors and hospitals to include ESSA’s products on their approved formulary lists, revenues may not meet expectations and ESSA’s business, results of operations and financial condition may be adversely affected.
  • The Company has never marketed a drug before, and if the Company is unable to establish an effective sales force and marketing infrastructure, or enter into acceptable third-party sales and marketing or licensing arrangements, the Company may be unable to generate any revenue.
  • In order to establish the Company’s sales and marketing infrastructure, the Company will need to expand the size of its organization and the Company may experience difficulties in managing this growth.
  • ESSA’s product candidate and potential future products may, if approved for sale, not achieve or maintain expected levels of market acceptance, which could have a material adverse effect on its business, financial condition and results of operations and could cause the market value of its securities to decline.
  • The Company may acquire businesses or products or form strategic alliances in the future and the Company may not realize the benefits of such acquisitions.
  • ESSA may seek to enter into collaborations with third parties for the development and commercialization of its product candidate and potential future product candidates. If ESSA fails to enter into such collaborations, or such collaborations are not successful, it may not be able to capitalize on the market potential of its product candidate and potential future product candidates.
  • ESSA’s employees may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could cause significant liability for ESSA and harm ESSA’s reputation.
  • If product liability lawsuits are brought against the Company, it may incur substantial liabilities and may be required to cease the sale, marketing and distribution of its product candidate and potential future products.
  • Compulsory licensing or generic competition may affect the Company’s business in certain countries.
  • ESSA incurs significantly increased costs and devotes substantial management time as a result of operating as a public company.
  • Effective September 30, 2021, ESSA no longer qualifies as an “an emerging growth company” and the reduced disclosure requirements applicable to emerging growth companies no longer apply, which will increase the Company’s costs and demands on management.
  • Risks Related to Additional Legal Compliance and Regulatory Matters
  • ESSA is subject to risks inherent in foreign operations.
  • Laws and regulations governing international operations may preclude ESSA from developing, manufacturing and selling certain product candidates outside of the United States and Canada and require ESSA to develop and implement costly compliance programs.
  • ESSA is subject to U.S. laws relating to fraud and abuse and patients’ rights.
  • If ESSA fails to comply with environmental, health and safety laws and regulations, ESSA could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of ESSA’s business.
  • The change from foreign private issuer to U.S. domestic issuer status may result in additional costs and expenses to us.
  • ESSA is and there is a risk that ESSA may continue to be a “passive foreign investment company” which would likely result in materially adverse U.S. federal income tax consequences for U.S. investors.
  • It may be difficult for United States investors to effect services of process or enforcement of actions against the Company or certain of its directors and officers under U.S. federal securities laws.
  • Risks Relating to ESSA’s Common Shares
  • The market price and trading volume of ESSA’s Common Shares may be volatile, which could result in rapid and substantial losses for its shareholders or securities litigation.
  • The Company has never declared dividends and may not do so in the future.
  • The Company may experience future sales or issue additional securities.
  • An active trading market for the Common Shares may not be sustained.
  • If ESSA is unable to implement and maintain effective internal controls over financial reporting in the future, ESSA may not be able to report financial results accurately or prevent fraud. In that case, investors may lose confidence in the accuracy and completeness of ESSA’s financial reports and the market price of ESSA’s Common Shares may be negatively affected.
  • Provisions in ESSA's corporate charter documents and Canadian law could make an acquisition of the Company, which may be beneficial to ESSA's shareholders, more difficult and may prevent attempts by the shareholders to replace or remove ESSA's current management and/or limit the market price of the Common Shares.
  • If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about ESSA’s business, its stock price and trading volume could decline.
Management Discussion
  • There was no revenue in any of the periods ended as reported. The Company incurred a comprehensive loss of $28,830,948 for the nine months ended June 30, 2022 compared to a comprehensive loss of $28,245,962 for the nine months ended June 30, 2021. Variations in ESSA’s expenses and net loss for the periods resulted primarily from the following factors:
  • The overall R&D expense for the nine months ended June 30, 2022 was $20,063,752 compared to $17,985,937 for the nine months ended June 30, 2021 and includes non-cash expense related to share-based payments expense of $3,253,741 (2021 - $2,323,185). R&D expense in the nine month periods ended June 30, 2022 and 2021 reflects the ongoing clinical trial of EPI-7386 which commenced in July 2020.
  • The share-based payments expense of $3,253,741 (2021 - $2,323,185), which is a non-cash expense, relates to the value assigned to stock options and employee share purchase rights granted to key management and consultants of the Company. The expense is recognized in relation to the grant and vesting of these equity instruments, net of expiries and forfeitures, and allocated to research and development, general and administration and financing expenditures relative to the activity of the underlying optionee.

Content analysis

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Positive
Negative
Uncertain
Constraining
Legalese
Litigous
Readability
H.S. sophomore Avg
New words: AIQ, anemia, baseline, brain, burden, complexity, ctDNA, denoting, doubling, endpoint, evidenced, excluded, genetic, harboring, induce, lesion, lung, milligram, month, move, neoadjuvant, neuroendocrine, opening, opportunity, overlapping, overt, platform, presence, prostatectomy, quantification, radiographic, RECIST, refinement, refining, regimen, traditional, unperturbed, visceral, volumetric, webcast
Removed: ADP, Advancing, approximate, breast, compelling, declining, encouraged, encouraging, ending, ensuring, evolution, expanding, favor, focusing, impacted, led, limitation, measurement, metabolized, modest, PARP, perform, poly, polymerase, poor, proof, readout, remain, resulting, ribose, situation, space, typical, unfavorable, usage

Patents

Utility
Pharmaceutical Compositions and Combinations Comprising Inhibitors of the Androgen Receptor and Uses Thereof
14 Jul 22
The present disclosure generally relates to pharmaceutical compositions and combinations comprising an androgen receptor N-terminal domain inhibitor or an inhibitor and a second therapeutically active agent, such as an CDK4/6 inhibitor, a Pin1 inhibitor (inhibitor of peptidyl-prolyl cis/trans isomerases), or an antiandrogen.
Utility
Pharmaceutical Compositions and Combinations Comprising Inhibitors of the Androgen Receptor and Uses Thereof
30 Jun 22
The present disclosure generally relates to pharmaceutical compositions and combinations comprising an androgen receptor modulator or an inhibitor and a second therapeutically active agent, such as an antiandrogen.
Utility
Solid forms of an N-terminal domain androgen receptor inhibitor and uses thereof
14 Jun 22
The present invention relates to a crystalline form of Compound I, a salt, a solvate, or a solvate salt thereof or an amorphous form of Compound I, a salt, a solvate, or a solvate salt thereof.
Utility
Solid Forms of an N-terminal Domain Androgen Receptor Inhibitor and Uses Thereof
10 Mar 22
The present invention relates to a crystalline form of Compound I, a salt, a solvate, or a solvate salt thereof or an amorphous form of Compound I, a salt, a solvate, or a solvate salt thereof.
Utility
Solid forms of an n-terminal domain androgen receptor inhibitor and uses thereof
8 Feb 22
The present invention relates to a crystalline form of Compound I, a salt, a solvate, or a solvate salt thereof or an amorphous form of Compound I, a salt, a solvate, or a solvate salt thereof.