AAVLP amyloid beta vaccine (2A Pharma)

TORONTO, Ontario and CAMBRIDGE, Massachusetts, March 08, 2023 (GLOBE NEWSWIRE) -- 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 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. “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 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 pro 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 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. About ProMIS Neurosciences Inc. 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. Forward-Looking Statements Neither the TSX nor Nasdaq has reviewed and neither accepts responsibility for the adequacy or accuracy of this release. Certain information in this news release constitutes forward-looking statements and forward-looking information (collectively, ‎‎“forward-looking information”) within the meaning of applicable securities laws. In some cases, but not necessarily in all cases, forward-looking information can be identified by the ‎use of forward-looking terminology such as “plans”, “targets”, “expects” or “does not expect”, “is expected”, “an opportunity exists”, ‎‎“is positioned”, “estimates”, “intends”, “assumes”, “anticipates” or “does not anticipate” or “believes”, or variations of such words and ‎phrases or state that certain actions, events or results “may”, “could”, “would”, “might”, “will” or “will be taken”, “occur” or “be ‎achieved”. In addition, any statements that refer to expectations, projections or other characterizations of future events or ‎circumstances contain forward-looking information. Specifically, this news release contains forward-looking information relating to targeting of toxic misfolded proteins that may directly address fundamental AD pathology (including that toxic oligomers of amyloid-beta are a major driver of AD) and have greater therapeutic potential due to reduction of off-target activity, the Company’s intention to IND for PMN310, the initiation of the Company’s first-in-human study subject to FDA clearance of its IND, and its ability to enroll the requisite number of patients, dose each patient in the intended manner, and progress the study, ProMIS’ pipeline, management’s belief that its patented platform technology has created an antibody candidate specific to toxic misfolded oligomers known to be present in Alzheimer’s disease, which may have greater therapeutic potential due to off-target activity, management’s anticipated timing of enrollment of the first subject in our Phase 1a trial in the first half of 2023, the progression of earlier stage antibody candidates for ALS (PMN267) and MSA (PMN442), the ability to continue its growth and realize the anticipated contribution of the members of its board of directors and executives to its operation and progress, the ability to optimize the impact of its collaborations on its development programs, statements regarding the timing of regulaotry filings regardings its development programs, use of capital expenses, future accumulated deficit and other financial results in the future, ability to fund operations, the ability to maintain enough liquidity to execute its business plan and its ability to continue as a going concern. Statements containing forward-looking information are not historical facts but instead represent management's current ‎expectations, estimates and projections regarding the future of our business, future plans, strategies, projections, anticipated events ‎and trends, the economy and other future conditions. Forward-looking information is necessarily based on a number of opinions, assumptions and estimates that, while considered reasonable by the Company as of the date of this news release, are subject to ‎known and unknown risks, uncertainties and assumptions and other factors that may cause the actual results, level of activity, ‎performance or achievements to be materially different from those expressed or implied by such forward-looking information. Important factors that could cause actual results to differ materially from those indicated in the forward-looking information include, among others, the factors discussed throughout the “Risk Factors” section of the Company's most recently filed annual information form available on and in Item 1A of each of its Form 10 Registration Statement and its Quarterly Reports on Form 10-Q for the quarters ended June 30, 2022 and September 30, 2022, each as filed with the Securities and Exchange Commission. Except as required by applicable securities laws, the Company undertakes no obligation to publicly update any forward-looking information, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. 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 For further information: Visit us at Please submit media inquiries to info@promisneursciences.com. For Investor Relations, please contact: Stern Investor Relations Suzanne Messere, Managing Director suzanne.messere@sternir.com Tel. 212 698-8801

Closed US$7.4 million private placementAppointed Gail Farfel, Ph.D., as Chief Executive OfficerContinued progress toward investigational new drug (IND) submission for PMN310 to pursue Alzheimer’s disease indication TORONTO, Ontario and CAMBRIDGE, Massachusetts, Nov. 14, 2022 (GLOBE NEWSWIRE) -- ProMIS Neurosciences Inc. (TSX: PMN) (Nasdaq: PMN), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic misfolded proteins implicated in the development of neurodegenerative diseases such as Alzheimer’s disease (AD), amyotrophic lateral sclerosis (ALS) and multiple system atrophy (MSA), today announced its third quarter 2022 financial results and recent highlights. “We continue to progress our therapeutic antibodies selective for toxic oligomers that are associated with the development and progression of neurodegenerative and other misfolded protein diseases. We are excited that our lead compound, PMN310, is advancing toward clinical stage development. Most notably, we recently closed a $7.4 million private placement, which will be used to advance PMN310 into a first-in-human study. We anticipate enrolling the first subject in the first half of 2023,” said Gail Farfel, Ph.D., Chief Executive Officer of ProMIS Neurosciences. “We believe our novel discovery platform gives us the potential to advance differentiated next-generation products to address urgent unmet medical needs as in ALS and MSA, and we are excited to continue our transition toward a clinical phase biotechnology company.” Recent Highlights and Anticipated Milestones Alzheimer’s Disease Program (PMN310)PMN310, ProMIS’s lead compound, is a novel monoclonal antibody that is highly selective for toxic oligomers of amyloid-beta that are believed to be a major driver of AD. ProMIS completed pilot toxicology, pharmacokinetics (PK) and tissue cross reactivity (TCR) studies and conducted the formal GLP studies to support an IND application to the U.S. Food and Drug Administration (FDA) and anticipate enrollment of the first subject in our Phase 1a trial in the first half of 2023 subject to FDA’s acceptance of the IND.ProMIS completed the first stage of development towards a high concentration formulation that could potentially support subcutaneous dosing as a future step to improve overall convenience and patient compliance. Other programs Using ProMIS’s discovery platform, the Company generated high-affinity monoclonal antibodies that are selective for the misfolded toxic form of TDP-43. In April 2022, the Company announced that it selected monoclonal antibody PMN267 as the drug candidate for an ALS indication based on its binding profile and activity in cell systems and a mouse model of disease. PMN267 is undergoing humanization in a human IgG1 framework for future clinical testing.ProMIS has selected monoclonal antibody PMN442 as its alpha-synuclein antibody drug candidate. In vivo testing in mouse disease models is ongoing with results expected in the second half of 2022. PMN442 is currently being humanized in a human IgG1 framework for future clinical testing.ProMIS continues to advance its amyloid-beta vaccine program with the aim of developing an AD vaccine containing its oligomer target epitopes conjugated to a carrier protein in formulation with an adjuvant. A vaccination study in a mouse model of AD is ongoing. Corporate In October 2022, ProMIS executed a securities purchase agreement to sell, through a private investment in public equity (PIPE) financing, 1,383,755 Units of the Company at a price of $5.40 per Unit for aggregate gross proceeds of $7.4 million, before deducting placement agent fees and other offering expenses.In September 2022, the Board of Directors approved the appointment of Gail Farfel, Ph.D., as the Company’s Chief Executive Officer, effective September 19, 2022.The Company’s co-founder and former Chief Executive Officer, Eugene Williams, remains as Chairman of the Board. Third Quarter Financial Highlights Cash and cash equivalents were $4.0 million as of September 30, 2022, compared to $17.0 million as of December 31, 2021. Net proceeds from the October 2022 financing were $6.4 million.Research and development expenses were $4.6 million for the third quarter ended September 30, 2022, compared to $0.8 million for the same period in 2021. The increase is primarily attributable to increased spending on the PMN310 program.General and Administrative expenses were $1.4 million for the third quarter ended September 30, 2022, compared to $1.3 million for the same period in 2021.Net loss was $6.0 million for the third quarter ended September 30, 2022, compared to $1.2 million for the same period in 2021. About ProMIS Neurosciences Inc. ProMIS Neurosciences Inc. is a development stage biotechnology company focused on discovering and developing antibody therapeutics selectively targeting toxic oligomers implicated in the development and progression of neurodegenerative diseases, in particular 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. Forward-Looking Statements Neither the TSX nor Nasdaq has reviewed and neither accepts responsibility for the adequacy or accuracy of this release. Certain information in this news release constitutes forward-looking statements and forward-looking information (collectively, ‎‎“forward-looking information”) within the meaning of applicable securities laws. In some cases, but not necessarily in all cases, forward-looking information can be identified by the ‎use of forward-looking terminology such as “plans”, “targets”, “expects” or “does not expect”, “is expected”, “an opportunity exists”, ‎‎“is positioned”, “estimates”, “intends”, “assumes”, “anticipates” or “does not anticipate” or “believes”, or variations of such words and ‎phrases or state that certain actions, events or results “may”, “could”, “would”, “might”, “will” or “will be taken”, “occur” or “be ‎achieved”. In addition, any statements that refer to expectations, projections or other characterizations of future events or ‎circumstances contain forward-looking information. Specifically, this news release contains forward-looking information relating to targeting of toxic misfolded proteins that may directly address fundamental AD pathology (including that toxic oligomers of amyloid-beta are a major driver of AD) and have greater therapeutic potential due to reduction of off-target activity, the initiation of the Company’s first-in-human study in 2023, ProMIS’ pipeline, the use of net proceeds of the PIPE, management’s belief that its patented platform technology has created an antibody candidate specific to toxic misfolded oligomers known to be present in Alzheimer’s disease, which may have greater therapeutic potential due to off-target activity, management’s anticipated timing of enrollment of the first subject in our Phase 1a trial in the first half of 2023, the progression of earlier stage antibody candidates for ALS (PMN267) and MSA (PMN442) . Statements containing forward-looking information are not historical facts but instead represent management's current ‎expectations, estimates and projections regarding the future of our business, future plans, strategies, projections, anticipated events ‎and trends, the economy and other future conditions. Forward-looking information is necessarily based on a number of opinions, assumptions and estimates that, while considered reasonable by the Company as of the date of this news release, are subject to ‎known and unknown risks, uncertainties and assumptions and other factors that may cause the actual results, level of activity, ‎performance or achievements to be materially different from those expressed or implied by such forward-looking information. Important factors that could cause actual results to differ materially from those indicated in the forward-looking information include, among others, the factors discussed throughout the “Risk Factors” section of the Company's most recently filed annual information form available on www.SEDAR.com, and in Item 1A of each of its Form 10 Registration Statement and its Quarterly Reports on Form 10-Q for the quarters ended June 30, 2022 and September 30, 2022, each as filed with the Securities and Exchange Commission. Except as required by applicable securities laws, the Company undertakes no obligation to publicly update any forward-looking information, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. PROMIS NEUROSCIENCES INC. Condensed Consolidated Balance Sheets (expressed in US dollars, unless otherwise indicated)(Unaudited) September 30, December 31, 2022 2021 Assets Current assets: Cash $3,920,742 $16,943,905 Short-term investments 30,539 33,248 Prepaid expenses and other current assets 1,407,864 737,316 Total current assets 5,359,145 17,714,469 Property and equipment, net 788 4,671 Intangible assets, net 21,732 27,614 Total assets $5,381,665 $17,746,754 Liabilities and Shareholders’ Equity Current liabilities: Accounts payable $1,794,807 $408,981 Accrued liabilities 1,303,908 520,093 Total current liabilities 3,098,715 929,074 Convertible debt, net of issuance costs and debt discount — 3,906,057 Derivative liability — 5,379,878 Warrant liability 1,553,186 1,871,687 Total liabilities 4,651,901 12,086,696 Commitments and contingencies (Note 13) Shareholders’ 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 September 30, 2022 and December 31, 2021, respectively — — Common Shares, no par value, unlimited shares authorized, 7,195,529 shares issued and outstanding as of September 30, 2022 and December 31, 2021 — — Additional paid-in capital 73,988,039 68,039,178 Accumulated other comprehensive loss (270,316) (187,919)Accumulated deficit (72,987,959) (62,191,201)Total shareholders’ equity 729,764 5,660,058 Total liabilities and shareholders’ equity $5,381,665 $17,746,754 PROMIS NEUROSCIENCES INC. Condensed Consolidated Statements of Operations and Comprehensive Loss (expressed in US dollars, except share and per share amounts)(Unaudited) For the For the For the For the Three Months Ended Three Months Ended Nine Months Ended Nine Months Ended September 30, September 30, September 30, September 30, 2022 2021 2022 2021 Operating expenses: Research and development $4,570,562 $805,392 $9,702,978 $1,779,285 General and administrative 1,483,573 1,265,486 5,154,324 1,964,978 Total operating expenses 6,054,135 2,070,878 14,857,302 3,744,263 Loss from operations (6,054,135) (2,070,878) (14,857,302) (3,744,263) Other income (expense): Interest expense, net — (140,912) (282,064) (276,317)Change in fair value of financial instruments 61,407 997,095 2,972,272 (3,526,590)Gain on extinguishment of convertible debt and derivative liability — — 1,307,421 — Other income 35,853 4,052 62,915 1,673 Total other income (expense), net 97,260 860,235 4,060,544 (3,801,234) Net loss (5,956,875) (1,210,643) (10,796,758) (7,545,497)Other comprehensive gain/(loss): Gain/(loss) on foreign currency translation (131,874) 42,659 (82,397) (102,558)Comprehensive loss $(6,088,749) $(1,167,984) $(10,879,155) $(7,648,055)Net loss per Common Share, basic and diluted $(0.85) $(0.20) $(1.51) $(1.44)Weighted-average Common Shares, basic and diluted 7,195,529 5,919,485 7,195,529 5,310,483 For further information: Visit us at www.promisneurosciences.com Follow us on Twitter or LinkedIn For media inquiries, please contact: Shanti Skiffingtonshanti.skiffington@promisneurosciences.comTel. 617 921-0808 For Investor Relations, please contact: Stern Investor RelationsSuzanne Messere, Managing Directorsuzanne.messere@sternir.comTel. 212 698-8801