ProMIS Neurosciences (PMN)

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ProMIS Neurosciences (PMN) - 2024 Q1 - Quarterly Report
2024-05-14 20:31
Table of Contents For the quarterly period ended March 31, 2024 UNITED STATES SECURITIES AND EXCHANGE COMMISSION OR Washington, D.C. 20549 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Toronto, Ontario M4S 3E2 (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code: 416-847- ...
ProMIS Neurosciences (PMN) - 2024 Q1 - Quarterly Results
2024-05-14 20:25
Exhibit 99.1 ProMIS Neurosciences Announces First Quarter 2024 Financial Results and Recent Highlights Top-line data from first-in-human Phase 1a clinical trial of PMN310 as a treatment for Alzheimer's disease on track for mid-2024 CAMBRIDGE, Massachusetts and TORONTO, Ontario – May 14, 2024 – ProMIS Neurosciences Inc. (Nasdaq: PMN), a clinical-stage biotechnology company focused on the generation and development of antibody therapeutics targeting toxic misfolded proteins in neurodegenerative diseases such ...
ProMIS Neurosciences (PMN) - 2023 Q4 - Annual Report
2024-04-01 20:21
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For The Transition Period From To Commission file number: 001-41429 PROMIS NEUROSCIENCES INC. (Exact name of registrant as specified in its charter) Ontario, Canada 98-0647155 (State of O ...
ProMIS Neurosciences (PMN) - 2023 Q4 - Annual Results
2024-04-01 20:15
Exhibit 99.1 ProMIS Neurosciences Announces Full Year 2023 Financial Results and Recent Highlights Top-line Data from first-in-human Phase 1a clinical trial of PMN310 as a treatment for Alzheimer's disease on track for mid-2024 CAMBRIDGE, Massachusetts and TORONTO, Ontario – April 1, 2024 – ProMIS Neurosciences Inc. (Nasdaq: PMN), a clinical-stage biotechnology company focused on the generation and development of antibody therapeutics targeting toxic misfolded proteins in neurodegenerative diseases such as ...
ProMIS Neurosciences (PMN) - 2023 Q3 - Quarterly Report
2023-11-14 21:40
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 Ontario, Canada 98-0647155 (State or other jurisdiction of incorporation or organization) Suite 200, 1920 Yonge Street (I.R.S. Employer Identification No.) Toronto, Ontario M4S 3E2 (Address of principal executive offices) (Zip Code) Registrant's telephone numbe ...
ProMIS Neurosciences (PMN) - 2023 Q2 - Quarterly Report
2023-08-14 21:03
[PART I - FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) [Item 1. Condensed Consolidated Financial Statements (unaudited)](index=5&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(unaudited)) The company's financial statements reflect a sharp cash decline, increased liabilities, and a growing net loss, raising going concern doubts [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets declined significantly due to decreased cash, while liabilities and the shareholders' deficit substantially increased Condensed Consolidated Balance Sheets (as of June 30, 2023 and December 31, 2022) | | June 30, 2023 (USD) | December 31, 2022 (USD) | | :--- | :--- | :--- | | **Assets** | | | | Cash | $1,222,660 | $5,875,796 | | Total current assets | $1,479,224 | $6,903,487 | | Total assets | $1,498,068 | $6,924,646 | | **Liabilities and Shareholders' Deficit** | | | | Accounts payable | $7,963,108 | $2,975,398 | | Total current liabilities | $8,738,960 | $6,413,044 | | Total liabilities | $10,026,360 | $8,272,418 | | Total shareholders' deficit | $(8,528,292) | $(1,347,772) | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Net loss significantly increased due to a sharp decline in other income, despite a reduction in operating expenses Operating Results Comparison (Six Months Ended June 30) | | 2023 (USD) | 2022 (USD) | | :--- | :--- | :--- | | Research and development | $4,515,967 | $5,132,416 | | General and administrative | $3,354,588 | $3,670,751 | | **Loss from operations** | **$(7,870,555)** | **$(8,803,167)** | | Total other income (expense), net | $599,150 | $3,963,284 | | **Net loss** | **$(7,271,405)** | **$(4,839,883)** | | Net loss per share, basic and diluted | $(0.85) | $(0.67) | Operating Results Comparison (Three Months Ended June 30) | | 2023 (USD) | 2022 (USD) | | :--- | :--- | :--- | | Research and development | $1,005,715 | $3,229,584 | | General and administrative | $1,894,169 | $1,635,065 | | **Loss from operations** | **$(2,899,884)** | **$(4,864,649)** | | **Net loss** | **$(2,311,974)** | **$(2,745,038)** | | Net loss per share, basic and diluted | $(0.27) | $(0.38) | [Condensed Consolidated Statements of Changes in Shareholders' Equity (Deficit)](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Shareholders'%20Equity%20(Deficit)) Shareholders' deficit significantly expanded, primarily driven by the net loss and foreign currency translation adjustments Changes in Shareholders' Deficit (For the Six Months Ended June 30, 2023) | Description | Amount (USD) | | :--- | :--- | | Balance, January 1, 2023 | $(1,347,772) | | Share-based compensation | $266,701 | | Foreign currency translation | $(175,816) | | Net loss | $(7,271,405) | | **Balance, June 30, 2023** | **$(8,528,292)** | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations improved, yet the overall cash balance significantly decreased with no investing or financing activities Cash Flow Summary (Six Months Ended June 30) | | 2023 (USD) | 2022 (USD) | | :--- | :--- | :--- | | Net cash used in operating activities | $(4,708,976) | $(7,844,557) | | Net cash used in investing activities | $— | $(2,048) | | Net decrease in cash | $(4,653,136) | $(8,040,129) | | **Cash at end of period** | **$1,222,660** | **$8,903,776** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the company's business focus, significant going concern doubt, accounting policies, equity, and R&D commitments - The company is focused on developing antibody therapies for neurodegenerative diseases, including Alzheimer's (AD), multiple system atrophy (MSA), and amyotrophic lateral sclerosis (ALS), using its proprietary technology platform[29](index=29&type=chunk) - Management has identified conditions that raise substantial doubt about the Company's ability to continue as a going concern. The company had a net loss of **$7.3 million** for the six months ended June 30, 2023, and an accumulated deficit of **$87.5 million**. Additional funding is required to continue operations[34](index=34&type=chunk) - In May 2023, the Company entered into an agreement with a vendor to defer payment on approximately **$5.3 million** of current accounts payable and accrued liabilities until March 31, 2024, with interest accruing at **5.5%** annually[50](index=50&type=chunk) - Subsequent to the quarter end, in July 2023, the company voluntarily delisted from the Toronto Stock Exchange (TSX) to consolidate its shares on Nasdaq and re-domiciled from federal Canadian jurisdiction to the Province of Ontario[81](index=81&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's neurodegenerative disease focus, significant losses, insufficient cash for 12 months, and dependence on future funding - The company's lead product candidate is PMN310 for Alzheimer's Disease. An Investigational New Drug (IND) application was filed with the FDA in April 2023 and cleared in May 2023. A Phase 1a clinical trial is planned, contingent on securing sufficient funding[85](index=85&type=chunk)[91](index=91&type=chunk) - The company's cash of **$1.2 million** as of June 30, 2023, is not sufficient to fund operating expenses for at least 12 months, raising substantial doubt about its ability to continue as a going concern[90](index=90&type=chunk)[116](index=116&type=chunk) R&D Expenses by Program (Six Months Ended June 30) | Program | 2023 (USD) | 2022 (USD) | | :--- | :--- | :--- | | PMN310 | $2,603,786 | $2,835,605 | | ALS | $— | $404,058 | | Platform and other programs | $298,915 | $308,030 | | **Total R&D Expenses** | **$4,515,967** | **$5,132,416** | General & Administrative Expenses (Six Months Ended June 30) | Category | 2023 (USD) | 2022 (USD) | | :--- | :--- | :--- | | Professional and consulting fees | $2,573,814 | $2,807,125 | | Employee salaries and benefits | $421,933 | $378,770 | | Share-based compensation | $188,683 | $141,273 | | **Total G&A Expenses** | **$3,354,588** | **$3,670,751** | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=29&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company faces significant liquidity and foreign currency exchange risks, with a 10% USD change impacting net loss by $0.8 million - The company's primary market risk is foreign currency exchange risk, as its functional currency is the Canadian dollar (C$) but it holds U.S. dollar (US$) denominated cash and liabilities[130](index=130&type=chunk) - As of June 30, 2023, a **10%** change in the USD exchange rate would impact the net loss by approximately **$0.8 million**[130](index=130&type=chunk) - Liquidity risk is a major concern, as the company is pre-revenue and depends on external fundraising to support operations and meet commitments[129](index=129&type=chunk) [Item 4. Controls and Procedures](index=29&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective with no material changes to internal control over financial reporting - Management concluded that as of June 30, 2023, the company's disclosure controls and procedures were effective[133](index=133&type=chunk) - There were no material changes in the company's internal control over financial reporting during the quarter ended June 30, 2023[134](index=134&type=chunk) [PART II - OTHER INFORMATION](index=30&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=30&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings - The company is not currently involved in any material legal proceedings[136](index=136&type=chunk) [Item 1A. Risk Factors](index=30&type=section&id=Item%201A.%20Risk%20Factors) Primary risk is financial viability, with substantial doubt about going concern due to recurring losses and need for additional funding - The company has incurred losses since inception and expects them to continue, raising substantial doubt about its ability to continue as a going concern[138](index=138&type=chunk) - The company had negative working capital of approximately **($7.3) million** as of June 30, 2023, and will require substantial additional funds for R&D, clinical testing, and regulatory approvals[139](index=139&type=chunk) - A failure to obtain necessary capital could force the company to delay, limit, reduce, or terminate its development programs and commercialization efforts[138](index=138&type=chunk)[140](index=140&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=31&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities occurred during the period - None[141](index=141&type=chunk) [Item 3. Defaults Upon Senior Securities](index=31&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) No defaults upon senior securities occurred during the period - None[142](index=142&type=chunk) [Item 4. Mine Safety Disclosures](index=31&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[143](index=143&type=chunk) [Item 5. Other Information](index=31&type=section&id=Item%205.%20Other%20Information) No other information to report for the period - None[143](index=143&type=chunk) [Item 6. Exhibits](index=32&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Quarterly Report, including CEO/CFO certifications and XBRL data - Exhibits filed include CEO and CFO certifications (**31.1, 31.2, 32.1**) and Inline XBRL documents (**101 series**)[145](index=145&type=chunk)
ProMIS Neurosciences (PMN) - 2023 Q1 - Quarterly Report
2023-05-15 21:05
[PART I FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) [Condensed Consolidated Financial Statements (unaudited)](index=3&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20%28unaudited%29) The company reported a significant increase in net loss to $5.0 million, decreased cash, and increased liabilities, raising substantial doubt about its ability to continue as a going concern [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Balance Sheet Summary | Financial Metric | March 31, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash | $3,331,801 | $5,875,796 | | Total Current Assets | $4,408,606 | $6,903,487 | | Total Assets | $4,428,274 | $6,924,646 | | **Liabilities & Shareholders' Deficit** | | | | Total Current Liabilities | $8,705,599 | $6,413,044 | | Total Liabilities | $10,607,321 | $8,272,418 | | Total Shareholders' Deficit | ($6,179,047) | ($1,347,772) | - Cash decreased by approximately **43%** from **$5.9 million** at the end of 2022 to **$3.3 million** as of March 31, 2023[15](index=15&type=chunk) - Total liabilities increased by **28%** to **$10.6 million**, primarily driven by a significant rise in accounts payable from **$3.0 million** to **$7.0 million**[15](index=15&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Operations and Comprehensive Loss Summary | Metric | Three Months Ended Mar 31, 2023 | Three Months Ended Mar 31, 2022 | | :--- | :--- | :--- | | Research and development | $3,510,252 | $1,902,832 | | General and administrative | $1,460,419 | $2,035,686 | | **Loss from operations** | **($4,970,671)** | **($3,938,518)** | | **Net loss** | **($4,959,431)** | **($2,094,845)** | | Net loss per share, basic and diluted | ($0.58) | ($0.29) | - Net loss more than doubled to **$5.0 million** in Q1 2023 from **$2.1 million** in Q1 2022, driven by an **84%** increase in research and development expenses[18](index=18&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash Flow Summary | Cash Flow Activity | Three Months Ended Mar 31, 2023 | Three Months Ended Mar 31, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | ($2,561,654) | ($3,366,768) | | Net cash used in investing activities | $0 | ($2,057) | | **Net decrease in cash** | **($2,543,995)** | **($3,189,694)** | | **Cash at end of quarter** | **$3,331,801** | **$13,754,211** | - The company used **$2.6 million** in cash for operating activities during the first three months of 2023[24](index=24&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) - The company's focus is on developing antibody therapies for neurodegenerative diseases, with lead candidates PMN310 for Alzheimer's, PMN442 for multiple system atrophy, and PMN267 for ALS[27](index=27&type=chunk)[28](index=28&type=chunk) - Management has identified a substantial doubt about the company's ability to continue as a going concern due to recurring net losses (**$5.0 million** in Q1 2023) and an accumulated deficit of **$85.2 million** Additional funding is required to continue operations[32](index=32&type=chunk) - In May 2023, the company entered an agreement to defer payment on approximately **$5.3 million** of current accounts payable and accrued liabilities until March 31, 2024, with interest accruing at **5.5%** annually[81](index=81&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=17&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses increased R&D expenses and a $5.0 million net loss, highlighting insufficient cash for 12 months and substantial doubt about going concern without additional financing [Program Updates](index=18&type=section&id=Program%20Updates) - The lead program, PMN310 for Alzheimer's Disease, progressed significantly with the successful manufacturing of the drug product and the filing of an Investigational New Drug (IND) application with the FDA in April 2023, which was cleared in May 2023[93](index=93&type=chunk)[94](index=94&type=chunk) - Expenditures for the PMN310 program in Q1 2023 were approximately **$2.4 million**[94](index=94&type=chunk) - Other key programs, including PMN267 for ALS and PMN442 for multiple system atrophy, have been humanized and are ready for IND-enabling studies[95](index=95&type=chunk)[96](index=96&type=chunk) [Result of Operations](index=20&type=section&id=Result%20of%20Operations) Operating Expenses Summary | Expense Category | Three Months Ended Mar 31, 2023 | Three Months Ended Mar 31, 2022 | Change | | :--- | :--- | :--- | :--- | | Research and development | $3,510,252 | $1,902,832 | $1,607,420 | | General and administrative | $1,460,419 | $2,035,686 | ($575,267) | | **Total operating expenses** | **$4,970,671** | **$3,938,518** | **$1,032,153** | - Research and development expenses increased by **$1.6 million** (**139%**) in Q1 2023 compared to Q1 2022, primarily due to a **$1.4 million** increase in spending on the lead program, PMN310, related to manufacturing and IND submission activities[110](index=110&type=chunk) - General and administrative expenses decreased by **$0.6 million** (**28%**), mainly due to a **$0.8 million** reduction in one-time costs related to the initial Nasdaq listing in 2022[112](index=112&type=chunk) [Liquidity and Capital Resources](index=21&type=section&id=Liquidity%20and%20Capital%20Resources) - The company is a development-stage entity with no revenue and has financed operations through equity and debt sales. As of March 31, 2023, it had an accumulated deficit of **$85.2 million**[114](index=114&type=chunk)[115](index=115&type=chunk) - Management believes the company's financial condition raises substantial doubt about its ability to continue as a going concern for the next 12 months, as additional funding is necessary to fund future clinical activities[115](index=115&type=chunk) - In May 2023, the company arranged to defer payment on approximately **$5.3 million** of current liabilities until March 31, 2024, providing some short-term liquidity relief[114](index=114&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=23&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is exposed to credit, liquidity, and foreign currency exchange risks, with a 10% USD exchange rate change impacting net loss by $0.6 million - The company's primary market risks are credit risk, liquidity risk, and foreign currency exchange risk[126](index=126&type=chunk) - The company is exposed to foreign exchange risk on its US dollar denominated cash and liabilities. As of March 31, 2023, a **10%** change in the USD exchange rate would impact net loss by approximately **$0.6 million**[129](index=129&type=chunk) - Liquidity risk is significant as the company is pre-revenue and relies on external fundraising to sustain operations[128](index=128&type=chunk) [Controls and Procedures](index=23&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective as of March 31, 2023, with no material changes in internal control over financial reporting - Management concluded that as of March 31, 2023, the company's disclosure controls and procedures were effective[132](index=132&type=chunk) - There were no material changes in the company's internal control over financial reporting during the quarter ended March 31, 2023[133](index=133&type=chunk) [PART II OTHER INFORMATION](index=24&type=section&id=PART%20II%20OTHER%20INFORMATION) [Legal Proceedings](index=24&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material litigation or legal proceedings likely to have a material adverse effect on its business - As of the filing date, the company is not involved in any material legal proceedings[135](index=135&type=chunk) [Risk Factors](index=24&type=section&id=Item%201A.%20Risk%20Factors) The company highlights significant risks including substantial doubt about its going concern ability, negative working capital, and the urgent need for additional financing - The company has incurred losses since inception and has substantial doubt about its ability to continue as a going concern, requiring additional financing to continue its development programs[137](index=137&type=chunk) - The company had negative working capital of approximately **$4.3 million** as of March 31, 2023[138](index=138&type=chunk) - There is a risk of adverse effects from instability in the financial services industry, as exemplified by the recent failures of Silicon Valley Bank and Signature Bank, which could impair access to funding or affect business partners[140](index=140&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=26&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities during the period - None[149](index=149&type=chunk) [Defaults Upon Senior Securities](index=26&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) There were no defaults upon senior securities during the period - None[150](index=150&type=chunk) [Mine Safety Disclosures](index=26&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[151](index=151&type=chunk) [Other Information](index=26&type=section&id=Item%205.%20Other%20Information) There is no other information to report for the period - None[151](index=151&type=chunk) [Exhibits](index=27&type=section&id=Item%206.%20Exhibits) The report includes several exhibits, primarily certifications from the Chief Executive Officer and Chief Financial Officer as required by the Sarbanes-Oxley Act, along with Inline XBRL documents - Exhibits filed with the report include CEO and CFO certifications pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act, and various XBRL data files[152](index=152&type=chunk)
Promis Neurosciences (PMN) Investor Presentation - Slideshow
2023-03-15 17:51
March 2023 NASDAQ: PMN Toronto Stock Exchange (TSX): PMN.TO This slide deck may contain certain forward-looking information. Such information involves known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by statements herein, and therefore these statements should not be read as guarantees of future performance or results. All forward-looking statements are based on ProMIS Neurosciences Inc.'s (the "C ...
ProMIS Neurosciences (PMN) - 2022 Q4 - Annual Report
2023-03-08 22:10
Part I [Item 1. Business](index=8&type=section&id=Item%201.%20Business) The company is a development-stage biotech firm using a computational platform for neurodegenerative disease therapies - ProMIS utilizes a patented, in-licensed technology platform that uses computational modeling to identify disease-specific epitopes on misfolded proteins, aiming to create **selective antibody therapies** for neurodegenerative diseases[23](index=23&type=chunk)[24](index=24&type=chunk)[25](index=25&type=chunk) - The company's lead product candidate is **PMN310**, a monoclonal antibody for Alzheimer's disease that selectively targets toxic amyloid-beta oligomers while avoiding plaque and healthy monomers[40](index=40&type=chunk) - Key objectives for 2023 include submitting the U.S. IND for PMN310 to initiate a **Phase 1 clinical study**, advancing another antibody into preclinical development, and conducting further preclinical work on an amyloid vaccine program[30](index=30&type=chunk) Main Product Pipeline Status | Product Candidate | Target Protein | Indication | Development Stage | | :--- | :--- | :--- | :--- | | PMN310 | Amyloid beta | Alzheimer's Disease (AD) | Preclinical (Phase 1 planned) | | PMN267 | TDP-43 | Amyotrophic Lateral Sclerosis (ALS) | Preclinical | | PMN442 | Alpha-synuclein | Multiple System Atrophy (MSA) | Preclinical | [Item 1A. Risk Factors](index=69&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant clinical, financial, operational, and regulatory risks as an early-stage entity - The company's product candidates are in **early development stages**, requiring significant additional investment with no guarantee of regulatory approval or commercial success[203](index=203&type=chunk)[207](index=207&type=chunk) - ProMIS has a history of incurring losses and anticipates continued losses, raising **substantial doubt about its ability to continue as a going concern** without additional capital[278](index=278&type=chunk)[280](index=280&type=chunk) - The company **relies on third parties** for research, development, manufacturing, and potential marketing of its product candidates, and the loss of these relationships could hinder development[285](index=285&type=chunk)[286](index=286&type=chunk) - Success is dependent on obtaining and maintaining sufficient **intellectual property protection**, as failure to do so could allow competitors to develop similar products[313](index=313&type=chunk)[314](index=314&type=chunk) - The business is subject to **extensive healthcare regulations**, and non-compliance could result in substantial penalties, while approved products will face ongoing oversight and pricing pressures[397](index=397&type=chunk)[401](index=401&type=chunk)[417](index=417&type=chunk) [Item 1B. Unresolved Staff Comments](index=161&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports no unresolved staff comments from the SEC - None[494](index=494&type=chunk) [Item 2. Properties](index=161&type=section&id=Item%202.%20Properties) The company does not own or lease any material properties - The Company does not own or lease any material properties[494](index=494&type=chunk) [Item 3. Legal Proceedings](index=162&type=section&id=Item%203.%20Legal%20Proceedings) The company is not party to any material legal proceedings - The company is not currently a party to any litigation or legal proceedings that management believes would have a material adverse effect on the business[495](index=495&type=chunk) [Item 4. Mine Safety Disclosures](index=162&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section is not applicable to the company's operations - Not applicable[496](index=496&type=chunk) Part II [Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=162&type=section&id=Item%205.%20Market%20for%20Registrant's%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common shares trade on Nasdaq and TSX under the symbol "PMN" with no dividends paid - The company's common shares trade on the **Nasdaq Capital Market** and the **Toronto Stock Exchange (TSX)** under the ticker symbol "PMN"[497](index=497&type=chunk) - **No dividends** have been declared or paid in the last five fiscal years, and the company does not expect to pay dividends in the foreseeable future[498](index=498&type=chunk)[499](index=499&type=chunk) - During 2022, the company issued unregistered securities, including stock options, Series 1 Preferred Shares, and units in a PIPE offering[502](index=502&type=chunk)[507](index=507&type=chunk) [Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=167&type=section&id=Item%207.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The company reported a wider net loss of $18.1 million in 2022, driven by higher R&D and G&A expenses - The company has incurred significant operating losses since inception, with a **net loss of $18.1 million** for the year ended December 31, 2022, and an **accumulated deficit of $80.3 million**[520](index=520&type=chunk) - Management has concluded that its cash of $5.9 million as of December 31, 2022, is not sufficient to fund operations for the next 12 months, which raises **substantial doubt about the company's ability to continue as a going concern**[523](index=523&type=chunk)[542](index=542&type=chunk) Results of Operations (Years Ended December 31) | | 2022 | 2021 | Change | | :--- | :--- | :--- | :--- | | **Research and development** | $16,087,168 | $4,627,386 | $11,459,782 | | **General and administrative** | $7,292,744 | $3,663,707 | $3,629,037 | | **Total operating expenses** | $23,379,912 | $8,291,093 | $15,088,819 | | **Loss from operations** | ($23,379,912) | ($8,291,093) | ($15,088,819) | | **Other income/(expense)** | $5,317,649 | ($1,499,013) | $6,816,662 | | **Net loss** | **($18,062,263)** | **($9,790,106)** | **($8,272,157)** | Cash Flow Summary (Years Ended December 31) | | 2022 | 2021 | | :--- | :--- | :--- | | **Net cash used in operating activities** | ($17,033,883) | ($9,305,383) | | **Net cash provided by (used in) investing activities** | ($1,981) | $94,618 | | **Net cash provided by financing activities** | $6,494,654 | $25,522,801 | | **Net (decrease) increase in cash** | ($11,068,109) | $16,137,018 | [Item 7A. Quantitative and Qualitative Disclosures About Market Risk](index=179&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is exposed to credit, liquidity, and foreign currency risks, with minimal impact from inflation - The company faces **liquidity risk** as a pre-revenue development stage company and relies on external fundraising to support operations[559](index=559&type=chunk) - ProMIS is exposed to **foreign exchange risk** on its U.S. dollar denominated assets and liabilities; a 10% change in the U.S. exchange rate would impact net loss by approximately **$0.2 million**[560](index=560&type=chunk) - **Inflation** is not considered to have had a material effect on the company's business or financial results during 2022 or 2021[561](index=561&type=chunk) [Item 8. Financial Statements and Supplementary Data](index=181&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) The financial statements show a net loss of $18.1 million for 2022 and a going concern uncertainty warning - The independent auditor's report includes a paragraph expressing **substantial doubt about the Company's ability to continue as a going concern** due to its accumulated deficit and net losses[566](index=566&type=chunk) Consolidated Balance Sheet Data (as of December 31) | | 2022 | 2021 | | :--- | :--- | :--- | | **Total Current Assets** | $6,903,487 | $17,714,469 | | **Total Assets** | $6,924,646 | $17,746,754 | | **Total Current Liabilities** | $6,413,044 | $929,074 | | **Total Liabilities** | $8,272,418 | $12,086,696 | | **Total Shareholders' (Deficit) Equity** | ($1,347,772) | $5,660,058 | Consolidated Statement of Operations Data (for the year ended December 31) | | 2022 | 2021 | | :--- | :--- | :--- | | **Total operating expenses** | $23,379,912 | $8,291,093 | | **Loss from operations** | ($23,379,912) | ($8,291,093) | | **Net loss** | ($18,062,263) | ($9,790,106) | | **Net loss per share, basic and diluted** | ($2.41) | ($1.69) | [Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=227&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company engaged Baker Tilly US, LLP as its principal auditor in 2022 and reports no material disagreements - The company engaged Baker Tilly US, LLP in December 2021 to perform a U.S. audit, and **Baker Tilly became the principal auditor in July 2022**[705](index=705&type=chunk) - There were **no material disagreements** with the accountant on accounting and financial disclosure during the audits for the periods ending December 31, 2022 and 2021[707](index=707&type=chunk) [Item 9A. Controls and Procedures](index=227&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of the end of the fiscal year - Management concluded that the company's **disclosure controls and procedures were effective** as of December 31, 2022[709](index=709&type=chunk) - The annual report does not include a management assessment of internal control over financial reporting, as permitted for **newly public companies**[710](index=710&type=chunk) - There were **no changes in internal control** over financial reporting during the quarter ended December 31, 2022, that have materially affected, or are reasonably likely to materially affect, internal controls[711](index=711&type=chunk) Part III [Item 10. Directors, Executive Officers, and Corporate Governance](index=229&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%2C%20and%20Corporate%20Governance) This section details the company's leadership team, board structure, and corporate governance framework - The executive team is led by **CEO Gail Farfel**, who joined in September 2022, and the Board is chaired by **Eugene Williams**[716](index=716&type=chunk)[717](index=717&type=chunk)[729](index=729&type=chunk) - The Board has three main committees: **Audit, Corporate Governance and Nominating, and Compensation**, with a majority of members identified as independent[746](index=746&type=chunk)[750](index=750&type=chunk)[760](index=760&type=chunk) - The company has adopted a **Code of Business Conduct and Ethics** applicable to all employees, officers, and directors[747](index=747&type=chunk) [Item 11. Executive Compensation](index=245&type=section&id=Item%2011.%20Executive%20Compensation) Executive compensation for 2022 consisted of base salary and equity awards for named executive officers - The company's compensation policy for named executive officers (NEOs) utilizes **base salary and long-term equity incentives** like stock options to be competitive and align interests with shareholders[774](index=774&type=chunk)[775](index=775&type=chunk) - Employment agreements are in place for key executives, detailing base salaries, bonus eligibility, and severance arrangements; CEO Gail Farfel's agreement includes a **$500,000 base salary** and a target bonus of **50% of her annualized base salary**[785](index=785&type=chunk)[793](index=793&type=chunk)[794](index=794&type=chunk) Summary Compensation Table for 2022 | Name and Principal Position | Year | Salary ($) | Bonus ($) | Option Awards ($) | All Other Compensation ($) | Total ($) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Gail Farfel, CEO | 2022 | $144,231 | $25,000 | $839,932 | $8,000 | $992,163 | | Eugene Williams, Chairman & Former CEO | 2022 | $419,942 | $0 | $243,929 | $19,266 | $683,137 | | Gavin Malenfant, COO | 2022 | $380,000 | $0 | $0 | $33,489 | $413,489 | | Neil Cashman, CSO | 2022 | $333,795 | $0 | $243,929 | $0 | $577,724 | [Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=258&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Directors and executives beneficially own 9.69% of common shares, with two entities holding over 5% each - As of February 6, 2023, all directors and executive officers as a group beneficially owned 920,557 common shares, representing **9.69% of the class**[817](index=817&type=chunk) - Two entities are reported as beneficial owners of more than 5% of the company's shares: **Title 19 Investments LLC** and **Crocker Mountain LLC**, each holding **9.99%**[817](index=817&type=chunk) Equity Compensation Plan Information (as of Dec 31, 2022) | Plan Category | Securities to be issued upon exercise (a) | Securities remaining available for future issuance (c) | | :--- | :--- | :--- | | Equity compensation plans approved by security holders | 1,044,086 | 411,685 | [Item 13. Certain Relationships and Related Transactions, and Director Independence](index=261&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) The company discloses transactions with entities related to its CSO, CFO, and major shareholders - The company has a collaborative research agreement with the **University of British Columbia (UBC)**, where CSO Dr. Neil Cashman is a principal investigator, incurring **$557,665** in related costs in 2022[823](index=823&type=chunk) - Consulting services are provided by **Danforth Advisors, LLC**, a firm where CFO Daniel Geffken is a managing director, with payments totaling **$365,247** in 2022[823](index=823&type=chunk) - Major shareholders, **Title 19 Promis** and **Crocker Mountain LLC**, participated in significant financing activities, including convertible debenture and PIPE offerings[826](index=826&type=chunk)[827](index=827&type=chunk)[829](index=829&type=chunk) - The Board has determined that **six of its directors are independent** under Nasdaq corporate governance rules[831](index=831&type=chunk) [Item 14. Principal Accountant Fees and Services](index=266&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) Total accountant fees were $389,000 in 2022, with all services pre-approved by the Audit Committee - The Audit Committee has a policy that requires **pre-approval of all audit and non-audit services** provided by the independent auditor[834](index=834&type=chunk) Accountant Fees (in thousands) | Fee Category | 2022 | 2021 | | :--- | :--- | :--- | | Audit Fees | $245 | $315 | | Audit-Related Fees | $117 | $19 | | Tax Fees | $27 | $11 | | **Total Fees** | **$389** | **$345** | Part IV [Item 15. Exhibits and Financial Statement Schedules](index=268&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists all financial statements, schedules, and exhibits filed as part of the annual report - This section contains the list of financial statements filed with the report[839](index=839&type=chunk)[843](index=843&type=chunk) - An index of all exhibits filed with the Form 10-K is provided, including corporate governance documents, material agreements, and officer certifications[841](index=841&type=chunk)[845](index=845&type=chunk) [Item 16. Form 10-K Summary](index=268&type=section&id=Item%2016.%20Form%2010-K%20Summary) This item is not applicable to the company's filing - Not applicable[842](index=842&type=chunk)
ProMIS Neurosciences (PMN) - 2022 Q2 - Quarterly Report
2022-08-12 11:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-41429 PROMIS NEUROSCIENCES INC. (Exact name of Registrant as specified in its Charter) Canada 98-0647155 (State ...