ProMIS Neurosciences Inc. (TSX: PMN) (Nasdaq: PMN), a biotechnology company focused on the generation and development of antibody therapeutics targeting toxic misfolded proteins in neurodegenerative diseases such as Alzheimer’s disease (AD), amyotrophic lateral sclerosis (ALS) and multiple system atrophy (MSA), today announced its full year 2022 financial results and recent highlights.
- Completed all preclinical studies and manufacturing to support PMN310 IND submission to U.S. Food and Drug Administration
- Preclinical data that further characterize ongoing programs, including PMN310, to be presented in 2023
“This year looks to be a pivotal one for ProMIS as we continue our plans to advance PMN310, our novel Alzheimer’s disease product candidate, and expect to file our IND within the next 60 days,” said Gail Farfel, Ph.D., Chief Executive Officer of ProMIS Neurosciences. “Progressing to the clinical stage of development will be a significant step toward our goal of delivering a next-generation therapy to patients with Alzheimer’s disease who have limited options to slow cognitive decline. In addition, we are working to advance two discovery programs, PMN267 and PMN442, towards IND readiness and advancing our amyloid vaccine for AD. We look forward to sharing data from our ongoing efforts over the coming months.”
Recent Highlights and Anticipated Milestones
Alzheimer’s Disease Program (PMN310)
PMN310, ProMIS’s lead compound, is a novel monoclonal antibody which is highly selective for toxic oligomers of amyloid-beta that are believed to be a major driver of AD. The Company has the following updates:
- Progressed preparation of the PMN310 investigational new drug application (IND), which is expected to be submitted to the U.S. Food and Drug Administration (FDA) within the next 60 days.
- Completed successful manufacture and packaging of PMN310 drug product under good manufacturing process (cGMP) for planned clinical trials.
- Completed non-human primate toxicology and pharmacokinetics studies, as well as tissue cross-reactivity studies under good laboratory practice (GLP) conditions to support first-in-human studies. PMN310 administered as a 30‑minute weekly IV infusion to cynomolgus monkeys at dose levels of up to 1200 mg/kg/day was not associated with any adverse effects. As a human equivalent dose, 1200 mg/kg/day in the cynomolgus monkey equates to 5 times higher than the planned highest dose for the Phase 1 trials.
- Plans to initiate a Phase 1a clinical trial of PMN310 subject to the filing and clearance of an IND application with the FDA. The planned Phase 1a single ascending dose trial in healthy volunteers will test single doses in the range of approximately 2.5 to 60 mg/kg in adults.
- Plans to share new preclinical data that further characterize PMN310 at upcoming medical meetings in March and April 2023.
Discovery programs
- ProMIS continues to advance its amyloid-beta vaccine program with the aim of developing an AD vaccine based on its oligomer target epitope(s) conjugated to a carrier protein in formulation with an adjuvant. The Company plans to provide preclinical data on vaccine optimization studies at a medical meeting in April 2023.
- In April 2022, ProMIS announced the selection of monoclonal antibody PMN267 directed against misfolded TDP-43 as the lead candidate for an ALS indication based on its selective binding profile and activity in cell systems and a mouse model of disease. PMN267 has been humanized in a human IgG1 framework for future testing.
- ProMIS has selected monoclonal antibody PMN442 as its alpha-synuclein antibody lead candidate for MSA based on its selective binding and protective activity against pathogenic forms of alpha-synuclein. PMN442 has been humanized in a human IgG1 framework for future testing.
Full Year 2022 Financial Highlights
- Cash and cash equivalents were $5.9 million as of December 31, 2022, compared to $16.9 million as of December 31, 2021.
- Research and development expenses were $16.1 million for the year ended December 31, 2022, compared to $4.6 million for the same period in 2021. The increase is primarily attributable to increased spending on the PMN310 program as the Company prepares to file an IND.
- General and Administrative expenses were $7.3 million for the year ended December 31, 2022, compared to $3.7 million for the same period in 2021.
- Net loss was $18.1 million for the year ended December 31, 2022, compared to $9.8 million for the same period in 2021.
ProMIS Neurosciences Inc. is a development stage biotechnology company focused on generating and developing antibody therapeutics selectively targeting toxic misfolded proteins in neurodegenerative diseases such as Alzheimer’s disease (AD), amyotrophic lateral sclerosis (ALS) and multiple system atrophy (MSA. The Company’s proprietary target discovery engine is based on the use of two complementary techniques. The Company applies its thermodynamic, computational discovery platform – ProMIS™ and Collective Coordinates – to predict novel targets known as Disease Specific Epitopes on the molecular surface of misfolded proteins. Using this unique approach, the Company is developing novel antibody therapeutics for AD, ALS and MSA. ProMIS has offices in Toronto, Ontario and Cambridge, Massachusetts. ProMIS is listed on Nasdaq and the Toronto Stock Exchange under the symbol PMN.
PROMIS NEUROSCIENCES INC.
Consolidated Balance Sheets
(expressed in US dollars, except share amounts)
| |
December 31, |
| |
2022 |
|
2021 |
| Assets |
| Current assets: |
| Cash |
$ |
5,875,796 |
$ |
16,943,905 |
| Short-term investments |
31,009 |
33,248 |
| Prepaid expenses and other current assets |
996,682 |
737,316 |
| Total current assets |
6,903,487 |
17,714,469 |
| Property and equipment, net |
321 |
4,671 |
| Intangible assets, net |
20,838 |
27,614 |
| Total assets |
$ |
6,924,646 |
$ |
17,746,754 |
| Liabilities and Shareholders’ (Deficit) Equity |
| Current liabilities: |
| Accounts payable |
$ |
2,975,398 |
$ |
408,981 |
| Accrued liabilities |
3,437,646 |
520,093 |
| Total current liabilities |
6,413,044 |
929,074 |
| Convertible debt, net of issuance costs and debt discount |
— |
3,906,057 |
| Derivative liability |
— |
5,379,878 |
| Warrant liability |
1,859,374 |
1,871,687 |
| Total liabilities |
8,272,418 |
12,086,696 |
| Commitments and contingencies |
| Shareholders’ (deficit) equity: |
| Series 1 Convertible Preferred Shares, no par value, 70,000,000 shares authorized, 70,000,000 and 0 shares issued and outstanding as of December 31, 2022 and December 31, 2021, respectively |
— |
— |
| Common shares, no par value, unlimited shares authorized, 8,579,284 and 7,195,529 shares issued and outstanding as of December 31, 2022 and 2021, respectively |
— |
— |
| Additional paid-in capital |
79,101,061 |
68,039,178 |
| Accumulated other comprehensive loss |
(195,369) |
(187,919) |
| Accumulated deficit |
(80,253,464) |
(62,191,201) |
| Total shareholders’ (deficit) equity |
(1,347,772) |
5,660,058 |
| Total liabilities and shareholders’ (deficit) equity |
$ |
6,924,646 |
$ |
17,746,754 |
PROMIS NEUROSCIENCES INC.
Consolidated Statements of Operations and Comprehensive Loss
(expressed in US dollars, except share amounts)
| |
Years Ended December 31, |
| |
2022 |
|
2021 |
| Operating expenses: |
| Research and development |
$ |
16,087,168 |
$ |
4,627,386 |
| General and administrative |
7,292,744 |
3,663,707 |
| Total operating expenses |
23,379,912 |
8,291,093 |
| Loss from operations |
(23,379,912) |
(8,291,093) |
| Other income (expense): |
| Change in fair value of financial instruments |
4,176,767 |
(1,095,636) |
| Interest expense on convertible debt |
(282,064) |
(416,286) |
| Gain on extinguishment of convertible debt and derivative liability |
1,307,421 |
— |
| Other income |
115,525 |
12,909 |
| Total other income (expense), net |
5,317,649 |
(1,499,013) |
| Net loss |
(18,062,263) |
(9,790,106) |
| Other comprehensive loss |
| Foreign currency translation adjustment |
(7,450) |
(137,188) |
| Comprehensive loss |
$ |
(18,069,713) |
$ |
(9,927,294) |
| Net loss per share, basic and diluted |
$ |
(2.41) |
$ |
(1.69) |
| Weighted-average shares outstanding of common shares, basic and diluted |
7,502,609 |
5,785,617 |
