ProMIS Neurosciences Announces Fiscal Year 2021 Results

News and Market Data on ProMIS Neurosciences

 

TORONTO, Ontario and CAMBRIDGE, Massachusetts , March 17, 2022 (GLOBE NEWSWIRE) — ProMIS Neurosciences, Inc. (TSX: PMN) (OTCQB: ARFXF) (“ProMIS” or the “Company”), a biotechnology company focused on the discovery and development of antibody therapeutics targeting misfolded proteins such as toxic oligomers, implicated in the development of neurodegenerative diseases, today announced its operational and financial results for the fiscal year ended December 31, 2021.

“2021 was an excellent year for ProMIS including strong capital formation which enabled us to advance and expand our portfolio of differentiated therapeutic product candidates such as Alzheimer’s disease (AD), ALS, and Schizophrenia,” said Gene Williams, ProMIS’ Chairman and CEO.   “We feel privileged that leading global experts continue to join our Scientific Advisory Board (SAB), accomplished executives are joining our Board of Directors, and that we have been able to supplement our strong management team, and we expect to continue those trends. We were grateful for the strong shareholder support for the resolution necessary to qualify for a potential listing on a major North American stock exchange presuming we meet the required listing standards. While biotechnology markets and specific disease sectors within biotechnology have cyclical ups and downs, we are well positioned to continue making substantive progress in our programs that could allow us to capitalize when markets rebound, as we believe they will.”

PMN310, an antibody selective for toxic oligomers in AD, is ProMIS’ lead product candidate. In the fourth quarter of 2021, the Company made significant progress on the program elements.

Producer cell line development is advancing. The genetic sequence of PMN310 has been transfected into Chinese hamster ovary (CHO) cells, the standard production cells for antibody manufacturing. We have contractually secured manufacturing slots for material to be used in Good Laboratory Practice (GLP) toxicology studies and for current Good Manufacturing Practice (cGMP) material for use in the initial clinical trials of PMN310, if allowed to proceed. In addition, we have contractually secured slots for GLP toxicology studies of various durations in nonhuman primates to support our single ascending dose/multiple ascending dose (SAD/MAD) trials. We have initiated pilot toxicology and pharmacokinetics (PK) studies to provide important information to support our GLP toxicology studies. We expect those PK studies to be completed in the second quarter of 2022. We also have secured slots for pilot and GLP tissue cross reactivity (TCR) studies, which are required for an investigational new drug (IND) application, in addition to GLP toxicology. The pilot TCR study was initiated fourth quarter of 2021 with an expected completion in second quarter 2022. Development of assays to measure drug levels in both nonhuman primate and human studies have been initiated and are expected to complete development in second quarter of 2022. Vendors have been contracted to perform these assays for our GLP studies.

In addition, in March 2022, we announced the results from a study assessing chronic systemic administration of PMN310 in a transgenic mouse model of Alzheimer’s disease, where the cognitive deficit is driven by toxic amyloid-beta oligomers. The results were positive, showing that PMN310 prevented a cognitive deficit as measured by performance in the water maze task.   

Cash expenditures for PMN310 in the six months ended December 31, 2021 were approximately $3.8 million. The largest component of this was a $2.7 million up-front and additional payments to our manufacturing vendor to secure manufacturing slots necessary for the filing of an IND and dosing of patients in our initial clinical trials. In addition, $834,000 of other external expenses and $326,000 was incurred for consulting fees of the program team, not including allocations of senior management time.

ALS Portfolio, including TAR-DNA binding protein 43 (TDP-43)

The top priority for our scientific validation efforts, largely centered in Dr. Neil Cashman’s laboratory at the University of British Columbia (UBC), is the Company’s ALS portfolio. This portfolio includes antibodies targeting misfolded forms of TDP-43, RACK1, and superoxide dismustase 1 (SOD1). TDP-43 is the focus of the PMN267 program. We are conducting both in vitro assays (assessing the impact of the drug on patient-derived motor neuron cell lines) and in vivo assays (mouse model) and expect initial data in the first half of 2022. In addition, we are exploring different therapeutic modalities in our ALS portfolio. We have disclosed data from our proof of concept work exploring “intrabody” versions of TDP-43 antibodies, a research proxy for a vectorized antibody in a gene therapy vector. We believe this therapeutic approach could enhance therapeutic benefit inside the motor neurons where misfolded TDP-43 aggregates are a root cause of disease pathology, leading to toxic misfolding of other proteins including RACK1 and SOD1. ProMIS’ capability to create highly selective antibodies is most critical in this application, since physiologically important TDP-43 is active inside the neuron and should be avoided by the intrabodies in order to reduce the possibility of harmful side effects. Based on the characterization of selected antibodies/intrabodies to date, we have declared PMN267 as our lead product candidate for the treatment of ALS. In addition, with world expert RNA scientist Dr. Michelle Hastings, ProMIS is exploring antisense oligonucleotide (ASO) therapeutic approaches, and with Dr. Justin Yerbury, is exploring protein degradation (PROTACS) approaches in ALS.

While targeting individual misfolded proteins is expected to provide a benefit, we believe an optimal disease modifying therapeutic approach to ALS may require addressing multiple misfolded protein targets (TDP-43, RACK1, and SOD1), with different modalities (antibody, gene therapy vectorized antibody, ASO, PROTAC). We are exploring the scientific interaction between therapies addressing these various targets, and our goal is to identify and develop a portfolio of complementary therapies that alone and/or together may play a significant role in effectively treating disease.

In the six months ended December 31, 2021, our total expenditures for the ALS portfolio were $299,000, not including allocations of senior management time.

Other key projects

In the six months ended December 31, 2021 we made significant progress on other key projects, in addition to our top priorities PMN310 for AD and PMN267 for ALS. We have engaged with a leading global expert in alpha synuclein to collaborate on further in vitro and in vivo validation of our potential therapies targeting alpha synuclein, both as extracellular antibodies and as intrabodies. Based on the characterization of selected antibodies to date, we have declared PMN442 as our lead alpha synuclein product candidate. Data from in vivo testing in mouse disease models are expected in the second half of 2022.

In our amyloid vaccine program, based on successful pilot work, University of Saskatchewan vaccine and infectious disease organization (VIDO) is conducting mouse studies in collaboration with ProMIS for the development of an optimized vaccine against Alzheimer’s disease, conjugating our peptide antigens to a carrier protein in formulation with an adjuvant. David Wishart, our Chief Physics Officer, and his team, are pursuing multiple novel targets including DISC1 involved in the pathogenesis of schizophrenia.

Recent Corporate Highlights

On May 12, 2021, Rudolph Tanzi, Ph.D., was appointed as the Chair of the Company’s Scientific Advisory Board (SAB). Dr. Tanzi is the Joseph P. and Rose F. Kennedy Professor of Neurology at Harvard University and Vice-Chair of Neurology, Director of the Genetics and Aging Research Unit, and Co-Director of the Henry and Allison McCance Center for Brain Health at Massachusetts General Hospital.

On May 21, 2021, the Company re-initiated the path to an IND application for PMN310 in Alzheimer’s with the start of producer cell line development. This key first step in the manufacturing of antibody therapeutics is being conducted by Selexis, SA, using its proprietary SUREtechnology Platform™.

On May 27, 2021, Dr. David Wishart, Distinguished University Professor in the Departments of Biological Sciences and Computing Science at the University of Alberta, was appointed as Chief Physics Officer.

On June 3, 2021, the Company announced that it had filed a preliminary Prospectus with the securities regulators in each of the provinces and territories of Canada, except Quebec. The Prospectus, when made final, will allow the Company to make offerings of common shares, warrants, units, debt securities, subscription receipts, convertible securities or any combination thereof for up to an aggregate total of US$50 million during the 25-month period that the Prospectus is effective.

On July 2, 2021, the Company announced the voting results of its annual meeting of shareholders held on June 30, 2021, in Vancouver, British Columbia, Canada. All resolutions described in the Management Proxy Circular and placed before the meeting were approved by the shareholders.

On July 8, 2021, the Company announced that it had filed and obtained a receipt for the Prospectus with the securities regulators in each of the provinces and territories of Canada, except Quebec.

On August 25, 2021, the Company announced the closing of a public offering for gross proceeds of US$20,125,000 (CDN$25,522,525).

On October 7, 2021, ProMIS announced that it would hold a special general meeting of shareholders (the “Special Meeting”) on December 1, 2021. The Company set October 18, 2021, as the record date for the Special Meeting. The purpose of the Special Meeting was to ask shareholders to grant the Board the authority, exercisable in the Board’s discretion, to consolidate (or reverse split) the Company’s issued and outstanding common shares in furtherance of a potential listing of the Company’s shares on a stock exchange in the United States, subject to meeting applicable quantitative and qualitative listing standards of such stock exchange. There can be no assurance that the Company will complete a listing on a stock exchange in the United States.

On December 2, 2021, the shareholders of the Company passed the share consolidation resolution at its special general meeting of shareholders.

On January 18, 2022, ProMIS appointed Dr. Carsten Korth to its SAB.

On January 27, 2022, ProMIS appointed Dr. Cheryl Wellington to its SAB.

On February 3, 2022, ProMIS appointed Dr. Guy Rouleau and Dr. Alain Dagher to its Scientific Advisory Board.

Financial highlights as of and for the year ended December 31, 2021, include:

• In March 2021, the Company completed a US$7.0 million (CDN$8.7 million) private placement of unsecured convertible debentures (Debentures).
  
  
• In August 2021, the Company raised gross proceeds of $25,522,525 ($23,426,746 net of share issuance costs).
  
  
• On December 31, 2021, the Company had funds available for operating activities (cash, cash equivalents and short-term investments) of $21,486,042, as compared to $1,071,004 at December 31, 2020. Our cash is sufficient to finance the Company’s operations through the end of 2023.
  
  

Additions to Board of Directors

• On May 19, 2021, the Company appointed Neil Warma, to the Company’s Board of Directors. Mr. Warma has been a healthcare entrepreneur for more than 25 years having managed and advised numerous biotechnology and pharmaceutical companies.
• On September 1, 2021, the Company appointed Josh Mandel-Brehm to the Board of Directors. Mr. Mandel-Brehm has held various key business development and operations leadership roles at leading biotechnology companies.
• On September 23, 2021, the Company appointed Maggie Shafmaster, JD, Ph.D., to the Board of Directors. Dr. Shafmaster has approximately 30 years of experience providing intellectual property advice to biotechnology and pharmaceutical industries.
  
  

Senior Management Team

On October 22, 2021, the Company announced the expansion of its senior management team. The following changes were announced:

• Eugene Williams, formerly Executive Chairman, takes on the role of Chairman and Chief Executive Officer (“CEO”), with immediate effect.
• Dr. Elliot Goldstein resigned from his current role as CEO with immediate effect and continues to support us as President and special consultant to the CEO.
• Gavin Malenfant joined our senior management team as Chief Operating Officer. Mr. Malenfant brings more than 30 years of biopharmaceutical experience to our team, with special focus on providing expert management and oversight of drug development programs. The top priority in the near term will be to support the timely development of the PMN310 program to completion of IND enabling activities, anticipated in the second half of 2022. 
  
  

Financial Results

Results of Operations – For the years ended December 31, 2021 and 2020

The following table summarizes our results of operations for the years ended December 31, 2021 and 2020:

		Years Ended
		December 31,
		2021				2020				Change
Revenues		$	16,410			$	1,787			$	14,623
Operating expenses
Research and development			6,310,299				3,183,149				3,127,150
General and administrative			4,224,609				2,481,030				1,743,579
Total operating expenses			10,534,908				5,664,179				4,870,729
Loss from operations			10,518,498				5,662,392				4,856,106
Other expense			1,265,917				–				1,265,917
Net loss		$	11,784,415			$	5,662,392			$	6,122,023

Revenues

The increase in revenues in the year ended December 31, 2021 represent royalties received on the Company’s assays.

Research and Development

Research and development expenses consist of the following:

		Years Ended
		December 31,
		2021				2020				Change
Direct research and development expenses by program:		$	4,293,649			$	976,700			$	3,316,949
Indirect research and development expenses:
Personnel related (including stock-based compensation)			812,278				1,672,145				(859,867	)
Consulting expense			588,164				173,712				414,452
Patent expense			557,957				344,864				213,093
Other operating costs			58,251				15,728				42,523
Total research and development expenses		$	6,310,299			$	3,183,149			$	3,127,150

The increase in research and development expense for the year ended December 31, 2021, compared to the year ended December 31, 2020, reflects increased costs associated with external contract research organizations for internal programs of $3,316,949 as the Company ramps up key internal programs and contract research organization costs, increased patent expense of $213,093 due to increased maintenance and filing fees, increased consulting expense of $414,452 and increase in amortization of property and equipment and intangible asset of $42,523 offset by decreased contract salaries and associated costs of $859,867 due to reduction in compensation to management and attrition of contracted staff and decreased share-based compensation of $154,015 due to forfeiture of unvested/vested share options due to termination of consulting arrangement.

General and Administrative

General and administrative expenses consist of the following:

		Years Ended December 31,
		2021				2020				Change
		(in thousands)
Personnel related (including stock-based compensation)		$	1,279,197			$	1,191,967			$	87,230
Professional and consulting fees			2,801,237				1,311,427				1,489,810
Facility-related and other			144,175				(22,364	)			166,539
Total general and administrative expenses		$	4,224,609			$	2,481,030			$	1,743,579

The increase for the year ended December 31, 2021, compared to the same period in 2020, is primarily attributable to an increase in legal expenses of $159,113, increased other professional, legal and consulting fees of 423,378, additional one-time fees of $459,051 related to a potential listing on a stock exchange in the United States, (subject to meeting applicable quantitative and qualitative listing standards of such stock exchange), increased share-based compensation of $306,695 related to the grant of share options, expensing of share issuance costs associated with the issuance of warrants in the August 2021 financing and base shelf costs of $717,806 and foreign exchange of expense of $166,539 on U.S. denominated assets and liabilities offset by a reduction in contracted corporate salaries and associated facility costs of $219,465 due to reduction in compensation to management and attrition of contracted staff and a decreased investor relations of $332,558 due to a reduction of investor relation activities and consultants.   Note that there can be no assurance that the Company will complete a listing on a stock exchange in the United States.  

Other Expense

The increase in other expense is primarily the valuation of the derivative liability associated with the convertible debenture financing and associated interest expense of $2,990,375 offset by the decrease in fair value of the warrant liability of $1,411,467 and the gain on the sale of lab equipment of $75,198.

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 Parkinson’s disease (PD). 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 PD. ProMIS is headquartered in Toronto, Ontario, with offices in Cambridge, Massachusetts. ProMIS is listed on the Toronto Stock Exchange under the symbol PMN, and on the OTCQB Venture Market under the symbol ARFXF.

Visit us at www.promisneurosciences.com, follow us on Twitter and LinkedIn

For Investor Relations please contact:
Alpine Equity Advisors
Nicholas Rigopulos, President
[email protected]
Tel. 617 901-0785

The TSX has not reviewed and does not accept 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 future management and Board composition of the Company; the potential listing of the Company’s shares on a stock exchange in the United States; the expectation that markets will rebound; the expected completion date of various studies and timelines for the development of assays; the potential benefits of targeting misfolded proteins; and the timing of PMN 442 in vivo testing data in mouse disease models. 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, 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 and financial condition 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. 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.

Source: ProMIS Neurosciences Inc.

ProMIS Neurosciences Announces Fiscal Year 2021 Results

News and Market Data on ProMIS Neurosciences

 

TORONTO, Ontario and CAMBRIDGE, Massachusetts , March 17, 2022 (GLOBE NEWSWIRE) — ProMIS Neurosciences, Inc. (TSX: PMN) (OTCQB: ARFXF) (“ProMIS” or the “Company”), a biotechnology company focused on the discovery and development of antibody therapeutics targeting misfolded proteins such as toxic oligomers, implicated in the development of neurodegenerative diseases, today announced its operational and financial results for the fiscal year ended December 31, 2021.

“2021 was an excellent year for ProMIS including strong capital formation which enabled us to advance and expand our portfolio of differentiated therapeutic product candidates such as Alzheimer’s disease (AD), ALS, and Schizophrenia,” said Gene Williams, ProMIS’ Chairman and CEO.   “We feel privileged that leading global experts continue to join our Scientific Advisory Board (SAB), accomplished executives are joining our Board of Directors, and that we have been able to supplement our strong management team, and we expect to continue those trends. We were grateful for the strong shareholder support for the resolution necessary to qualify for a potential listing on a major North American stock exchange presuming we meet the required listing standards. While biotechnology markets and specific disease sectors within biotechnology have cyclical ups and downs, we are well positioned to continue making substantive progress in our programs that could allow us to capitalize when markets rebound, as we believe they will.”

PMN310, an antibody selective for toxic oligomers in AD, is ProMIS’ lead product candidate. In the fourth quarter of 2021, the Company made significant progress on the program elements.

Producer cell line development is advancing. The genetic sequence of PMN310 has been transfected into Chinese hamster ovary (CHO) cells, the standard production cells for antibody manufacturing. We have contractually secured manufacturing slots for material to be used in Good Laboratory Practice (GLP) toxicology studies and for current Good Manufacturing Practice (cGMP) material for use in the initial clinical trials of PMN310, if allowed to proceed. In addition, we have contractually secured slots for GLP toxicology studies of various durations in nonhuman primates to support our single ascending dose/multiple ascending dose (SAD/MAD) trials. We have initiated pilot toxicology and pharmacokinetics (PK) studies to provide important information to support our GLP toxicology studies. We expect those PK studies to be completed in the second quarter of 2022. We also have secured slots for pilot and GLP tissue cross reactivity (TCR) studies, which are required for an investigational new drug (IND) application, in addition to GLP toxicology. The pilot TCR study was initiated fourth quarter of 2021 with an expected completion in second quarter 2022. Development of assays to measure drug levels in both nonhuman primate and human studies have been initiated and are expected to complete development in second quarter of 2022. Vendors have been contracted to perform these assays for our GLP studies.

In addition, in March 2022, we announced the results from a study assessing chronic systemic administration of PMN310 in a transgenic mouse model of Alzheimer’s disease, where the cognitive deficit is driven by toxic amyloid-beta oligomers. The results were positive, showing that PMN310 prevented a cognitive deficit as measured by performance in the water maze task.   

Cash expenditures for PMN310 in the six months ended December 31, 2021 were approximately $3.8 million. The largest component of this was a $2.7 million up-front and additional payments to our manufacturing vendor to secure manufacturing slots necessary for the filing of an IND and dosing of patients in our initial clinical trials. In addition, $834,000 of other external expenses and $326,000 was incurred for consulting fees of the program team, not including allocations of senior management time.

ALS Portfolio, including TAR-DNA binding protein 43 (TDP-43)

The top priority for our scientific validation efforts, largely centered in Dr. Neil Cashman’s laboratory at the University of British Columbia (UBC), is the Company’s ALS portfolio. This portfolio includes antibodies targeting misfolded forms of TDP-43, RACK1, and superoxide dismustase 1 (SOD1). TDP-43 is the focus of the PMN267 program. We are conducting both in vitro assays (assessing the impact of the drug on patient-derived motor neuron cell lines) and in vivo assays (mouse model) and expect initial data in the first half of 2022. In addition, we are exploring different therapeutic modalities in our ALS portfolio. We have disclosed data from our proof of concept work exploring “intrabody” versions of TDP-43 antibodies, a research proxy for a vectorized antibody in a gene therapy vector. We believe this therapeutic approach could enhance therapeutic benefit inside the motor neurons where misfolded TDP-43 aggregates are a root cause of disease pathology, leading to toxic misfolding of other proteins including RACK1 and SOD1. ProMIS’ capability to create highly selective antibodies is most critical in this application, since physiologically important TDP-43 is active inside the neuron and should be avoided by the intrabodies in order to reduce the possibility of harmful side effects. Based on the characterization of selected antibodies/intrabodies to date, we have declared PMN267 as our lead product candidate for the treatment of ALS. In addition, with world expert RNA scientist Dr. Michelle Hastings, ProMIS is exploring antisense oligonucleotide (ASO) therapeutic approaches, and with Dr. Justin Yerbury, is exploring protein degradation (PROTACS) approaches in ALS.

While targeting individual misfolded proteins is expected to provide a benefit, we believe an optimal disease modifying therapeutic approach to ALS may require addressing multiple misfolded protein targets (TDP-43, RACK1, and SOD1), with different modalities (antibody, gene therapy vectorized antibody, ASO, PROTAC). We are exploring the scientific interaction between therapies addressing these various targets, and our goal is to identify and develop a portfolio of complementary therapies that alone and/or together may play a significant role in effectively treating disease.

In the six months ended December 31, 2021, our total expenditures for the ALS portfolio were $299,000, not including allocations of senior management time.

Other key projects

In the six months ended December 31, 2021 we made significant progress on other key projects, in addition to our top priorities PMN310 for AD and PMN267 for ALS. We have engaged with a leading global expert in alpha synuclein to collaborate on further in vitro and in vivo validation of our potential therapies targeting alpha synuclein, both as extracellular antibodies and as intrabodies. Based on the characterization of selected antibodies to date, we have declared PMN442 as our lead alpha synuclein product candidate. Data from in vivo testing in mouse disease models are expected in the second half of 2022.

In our amyloid vaccine program, based on successful pilot work, University of Saskatchewan vaccine and infectious disease organization (VIDO) is conducting mouse studies in collaboration with ProMIS for the development of an optimized vaccine against Alzheimer’s disease, conjugating our peptide antigens to a carrier protein in formulation with an adjuvant. David Wishart, our Chief Physics Officer, and his team, are pursuing multiple novel targets including DISC1 involved in the pathogenesis of schizophrenia.

Recent Corporate Highlights

On May 12, 2021, Rudolph Tanzi, Ph.D., was appointed as the Chair of the Company’s Scientific Advisory Board (SAB). Dr. Tanzi is the Joseph P. and Rose F. Kennedy Professor of Neurology at Harvard University and Vice-Chair of Neurology, Director of the Genetics and Aging Research Unit, and Co-Director of the Henry and Allison McCance Center for Brain Health at Massachusetts General Hospital.

On May 21, 2021, the Company re-initiated the path to an IND application for PMN310 in Alzheimer’s with the start of producer cell line development. This key first step in the manufacturing of antibody therapeutics is being conducted by Selexis, SA, using its proprietary SUREtechnology Platform™.

On May 27, 2021, Dr. David Wishart, Distinguished University Professor in the Departments of Biological Sciences and Computing Science at the University of Alberta, was appointed as Chief Physics Officer.

On June 3, 2021, the Company announced that it had filed a preliminary Prospectus with the securities regulators in each of the provinces and territories of Canada, except Quebec. The Prospectus, when made final, will allow the Company to make offerings of common shares, warrants, units, debt securities, subscription receipts, convertible securities or any combination thereof for up to an aggregate total of US$50 million during the 25-month period that the Prospectus is effective.

On July 2, 2021, the Company announced the voting results of its annual meeting of shareholders held on June 30, 2021, in Vancouver, British Columbia, Canada. All resolutions described in the Management Proxy Circular and placed before the meeting were approved by the shareholders.

On July 8, 2021, the Company announced that it had filed and obtained a receipt for the Prospectus with the securities regulators in each of the provinces and territories of Canada, except Quebec.

On August 25, 2021, the Company announced the closing of a public offering for gross proceeds of US$20,125,000 (CDN$25,522,525).

On October 7, 2021, ProMIS announced that it would hold a special general meeting of shareholders (the “Special Meeting”) on December 1, 2021. The Company set October 18, 2021, as the record date for the Special Meeting. The purpose of the Special Meeting was to ask shareholders to grant the Board the authority, exercisable in the Board’s discretion, to consolidate (or reverse split) the Company’s issued and outstanding common shares in furtherance of a potential listing of the Company’s shares on a stock exchange in the United States, subject to meeting applicable quantitative and qualitative listing standards of such stock exchange. There can be no assurance that the Company will complete a listing on a stock exchange in the United States.

On December 2, 2021, the shareholders of the Company passed the share consolidation resolution at its special general meeting of shareholders.

On January 18, 2022, ProMIS appointed Dr. Carsten Korth to its SAB.

On January 27, 2022, ProMIS appointed Dr. Cheryl Wellington to its SAB.

On February 3, 2022, ProMIS appointed Dr. Guy Rouleau and Dr. Alain Dagher to its Scientific Advisory Board.

Financial highlights as of and for the year ended December 31, 2021, include:

• In March 2021, the Company completed a US$7.0 million (CDN$8.7 million) private placement of unsecured convertible debentures (Debentures).
  
  
• In August 2021, the Company raised gross proceeds of $25,522,525 ($23,426,746 net of share issuance costs).
  
  
• On December 31, 2021, the Company had funds available for operating activities (cash, cash equivalents and short-term investments) of $21,486,042, as compared to $1,071,004 at December 31, 2020. Our cash is sufficient to finance the Company’s operations through the end of 2023.
  
  

Additions to Board of Directors

• On May 19, 2021, the Company appointed Neil Warma, to the Company’s Board of Directors. Mr. Warma has been a healthcare entrepreneur for more than 25 years having managed and advised numerous biotechnology and pharmaceutical companies.
• On September 1, 2021, the Company appointed Josh Mandel-Brehm to the Board of Directors. Mr. Mandel-Brehm has held various key business development and operations leadership roles at leading biotechnology companies.
• On September 23, 2021, the Company appointed Maggie Shafmaster, JD, Ph.D., to the Board of Directors. Dr. Shafmaster has approximately 30 years of experience providing intellectual property advice to biotechnology and pharmaceutical industries.
  
  

Senior Management Team

On October 22, 2021, the Company announced the expansion of its senior management team. The following changes were announced:

• Eugene Williams, formerly Executive Chairman, takes on the role of Chairman and Chief Executive Officer (“CEO”), with immediate effect.
• Dr. Elliot Goldstein resigned from his current role as CEO with immediate effect and continues to support us as President and special consultant to the CEO.
• Gavin Malenfant joined our senior management team as Chief Operating Officer. Mr. Malenfant brings more than 30 years of biopharmaceutical experience to our team, with special focus on providing expert management and oversight of drug development programs. The top priority in the near term will be to support the timely development of the PMN310 program to completion of IND enabling activities, anticipated in the second half of 2022. 
  
  

Financial Results

Results of Operations – For the years ended December 31, 2021 and 2020

The following table summarizes our results of operations for the years ended December 31, 2021 and 2020:

		Years Ended
		December 31,
		2021				2020				Change
Revenues		$	16,410			$	1,787			$	14,623
Operating expenses
Research and development			6,310,299				3,183,149				3,127,150
General and administrative			4,224,609				2,481,030				1,743,579
Total operating expenses			10,534,908				5,664,179				4,870,729
Loss from operations			10,518,498				5,662,392				4,856,106
Other expense			1,265,917				–				1,265,917
Net loss		$	11,784,415			$	5,662,392			$	6,122,023

Revenues

The increase in revenues in the year ended December 31, 2021 represent royalties received on the Company’s assays.

Research and Development

Research and development expenses consist of the following:

		Years Ended
		December 31,
		2021				2020				Change
Direct research and development expenses by program:		$	4,293,649			$	976,700			$	3,316,949
Indirect research and development expenses:
Personnel related (including stock-based compensation)			812,278				1,672,145				(859,867	)
Consulting expense			588,164				173,712				414,452
Patent expense			557,957				344,864				213,093
Other operating costs			58,251				15,728				42,523
Total research and development expenses		$	6,310,299			$	3,183,149			$	3,127,150

The increase in research and development expense for the year ended December 31, 2021, compared to the year ended December 31, 2020, reflects increased costs associated with external contract research organizations for internal programs of $3,316,949 as the Company ramps up key internal programs and contract research organization costs, increased patent expense of $213,093 due to increased maintenance and filing fees, increased consulting expense of $414,452 and increase in amortization of property and equipment and intangible asset of $42,523 offset by decreased contract salaries and associated costs of $859,867 due to reduction in compensation to management and attrition of contracted staff and decreased share-based compensation of $154,015 due to forfeiture of unvested/vested share options due to termination of consulting arrangement.

General and Administrative

General and administrative expenses consist of the following:

		Years Ended December 31,
		2021				2020				Change
		(in thousands)
Personnel related (including stock-based compensation)		$	1,279,197			$	1,191,967			$	87,230
Professional and consulting fees			2,801,237				1,311,427				1,489,810
Facility-related and other			144,175				(22,364	)			166,539
Total general and administrative expenses		$	4,224,609			$	2,481,030			$	1,743,579

The increase for the year ended December 31, 2021, compared to the same period in 2020, is primarily attributable to an increase in legal expenses of $159,113, increased other professional, legal and consulting fees of 423,378, additional one-time fees of $459,051 related to a potential listing on a stock exchange in the United States, (subject to meeting applicable quantitative and qualitative listing standards of such stock exchange), increased share-based compensation of $306,695 related to the grant of share options, expensing of share issuance costs associated with the issuance of warrants in the August 2021 financing and base shelf costs of $717,806 and foreign exchange of expense of $166,539 on U.S. denominated assets and liabilities offset by a reduction in contracted corporate salaries and associated facility costs of $219,465 due to reduction in compensation to management and attrition of contracted staff and a decreased investor relations of $332,558 due to a reduction of investor relation activities and consultants.   Note that there can be no assurance that the Company will complete a listing on a stock exchange in the United States.  

Other Expense

The increase in other expense is primarily the valuation of the derivative liability associated with the convertible debenture financing and associated interest expense of $2,990,375 offset by the decrease in fair value of the warrant liability of $1,411,467 and the gain on the sale of lab equipment of $75,198.

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 Parkinson’s disease (PD). 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 PD. ProMIS is headquartered in Toronto, Ontario, with offices in Cambridge, Massachusetts. ProMIS is listed on the Toronto Stock Exchange under the symbol PMN, and on the OTCQB Venture Market under the symbol ARFXF.

Visit us at www.promisneurosciences.com, follow us on Twitter and LinkedIn

For Investor Relations please contact:
Alpine Equity Advisors
Nicholas Rigopulos, President
[email protected]
Tel. 617 901-0785

The TSX has not reviewed and does not accept 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 future management and Board composition of the Company; the potential listing of the Company’s shares on a stock exchange in the United States; the expectation that markets will rebound; the expected completion date of various studies and timelines for the development of assays; the potential benefits of targeting misfolded proteins; and the timing of PMN 442 in vivo testing data in mouse disease models. 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, 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 and financial condition 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. 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.

Source: ProMIS Neurosciences Inc.

Thursday, March 17, 2022

Baudax Bio (BXRX)
Fourth Quarter 2021 Reported; Major Expense Reductions Announced

Baudax Bio is a biopharmaceutical company focused on developing therapies for post-operative pain, peri-operative pain, and anesthesia. The company currently has one approved therapy in ANJESO for post-operative pain. Proprietary ANJESO (meloxicam) injection is the first and only once-daily IV analgesic. The company also has a pipeline of early-stage candidates with two novel neuromuscular blocking agents (NMBAs), a proprietary related reversal agent to their NMBAs, and Dex-IN, an intranasal formulation of dexmedetomidine (Dex) that has sedative, analgesic, and anti-anxiety properties.

Gregory Aurand, Senior Research Analyst, Healthcare Services & Medical Devices, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

4Q 2021 revenues reported. Yesterday, Baudax Bio released 4Q and FY 2021 results. Despite better-than-expected formulary wins, Covid related elective procedures remained muted in regions of the U.S. While solid, 4Q revenues of $.4 million, up 426%, missed our $0.55 million estimate. FY 2021 reported revenues of $1.08 million, up 119%, missed our $1.23 million estimate.

Company is reducing headcount and expenses.  The company is implementing a workplace reduction plan to curtail expenses and reduce need for capital. The plan is expected to reduce headcount 80%. The company expects approximately $4.0 million in severance and related costs to be taken by end of 2Q 2022. Cash burn will be substantially reduced in 2H 2022 and beyond …

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

 

BioSig Technologies, Inc. Appoints John Sieckhaus as Chief Operating Officer

News and Market Data on BioSig Technologies

 

Seasoned electrophysiology commercial leader joins the Company to expand operating capabilities

Westport, CT, March 16, 2022 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (Nasdaq: BSGM) (“BioSig” or the “Company”), a medical technology company commercializing an innovative signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals, today announced the appointment of John Sieckhaus as Chief Operating Officer.

Mr. Sieckhaus brings to the Company 30 years in the healthcare industry, including 21 years at St. Jude Medical and Abbott Laboratories [NYSE: ABT]. During his tenure with St. Jude Medical, Mr. Sieckhaus held commercial leadership positions of rising responsibility, including U.S. National Sales Leader, Senior Vice President & General Manager when he led sales and customer relationship management activities in the United States across all cardiovascular product lines.   Mr. Sieckhaus’s experience in building and leading high-performance teams, in addition to integrating multiple new and novel technologies and introducing them commercially, led to significant revenue growth for St. Jude Medical over his career. Most recently, Mr. Sieckhaus held the position of Vice President – Field Clinical Affairs for Abbott for the United States and CALA, where he created a world-class field clinical and monitoring team to support clinical trials across multiple business units within Abbott’s Cardiovascular portfolio. Mr. Sieckhaus holds a Bachelor of Science degree in Biomedical Engineering from Johns Hopkins University.

“I am very excited to join this team and look forward to building upon the foundation of the PURE EP™ system and its capabilities. Focusing in the area of electrophysiology by providing better solutions in identifying and treating complex arrhythmias for our clinical customers and patients will be extremely rewarding,” commented Mr. Sieckhaus

“We are pleased to welcome John to the team as we build toward a national rollout of our leading product, PURE EP ™. John’s leadership experience in the electrophysiology space and his impressive track record in capturing and growing market share in the U.S.  is well-aligned with our mission to bring our signal processing technology to as many hospitals as possible in the coming years. John will join Gray Fleming in helping run and grow our business while attracting additional talent to the Company,” commented Kenneth L. Londoner, Chairman and CEO of BioSig Technologies, Inc.

The PURE EP™ is an FDA 510(k) cleared non-invasive class II device that aims to drive procedural efficiency and efficacy in cardiac electrophysiology. To date, 75 physicians have completed more than 2150 patient cases with the PURE EP™ System.

Clinical data acquired by the PURE EP™ System in a multi-center study at Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Mayo Clinic Jacksonville, and Massachusetts General Hospital was recently published in the Journal of Cardiovascular Electrophysiology and is available electronically with open access via the Wiley Online Library. Study results showed 93% consensus across the blinded reviewers with a 75% overall improvement in intracardiac signal quality and confidence in interpreting PURE EP™  signals over conventional sources.

About BioSig Technologies
BioSig Technologies is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals (www.biosig.com).

The Company’s first product, PURE EP™ System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording, and storing electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory.

Forward-looking Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward- looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (ii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iii) difficulties in obtaining financing on commercially reasonable terms; (iv) changes in the size and nature of our competition; (v) loss of one or more key executives or scientists; and (vi) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

Andrew Ballou
BioSig Technologies, Inc.
Vice President, Investor Relations
55 Greens Farms Road
Westport, CT 06880
[email protected]
203-409-5444, x133

Source: BioSig Technologies, Inc.

BioSig Technologies, Inc. Appoints John Sieckhaus as Chief Operating Officer

News and Market Data on BioSig Technologies

 

Seasoned electrophysiology commercial leader joins the Company to expand operating capabilities

Westport, CT, March 16, 2022 (GLOBE NEWSWIRE) — BioSig Technologies, Inc. (Nasdaq: BSGM) (“BioSig” or the “Company”), a medical technology company commercializing an innovative signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals, today announced the appointment of John Sieckhaus as Chief Operating Officer.

Mr. Sieckhaus brings to the Company 30 years in the healthcare industry, including 21 years at St. Jude Medical and Abbott Laboratories [NYSE: ABT]. During his tenure with St. Jude Medical, Mr. Sieckhaus held commercial leadership positions of rising responsibility, including U.S. National Sales Leader, Senior Vice President & General Manager when he led sales and customer relationship management activities in the United States across all cardiovascular product lines.   Mr. Sieckhaus’s experience in building and leading high-performance teams, in addition to integrating multiple new and novel technologies and introducing them commercially, led to significant revenue growth for St. Jude Medical over his career. Most recently, Mr. Sieckhaus held the position of Vice President – Field Clinical Affairs for Abbott for the United States and CALA, where he created a world-class field clinical and monitoring team to support clinical trials across multiple business units within Abbott’s Cardiovascular portfolio. Mr. Sieckhaus holds a Bachelor of Science degree in Biomedical Engineering from Johns Hopkins University.

“I am very excited to join this team and look forward to building upon the foundation of the PURE EP™ system and its capabilities. Focusing in the area of electrophysiology by providing better solutions in identifying and treating complex arrhythmias for our clinical customers and patients will be extremely rewarding,” commented Mr. Sieckhaus

“We are pleased to welcome John to the team as we build toward a national rollout of our leading product, PURE EP ™. John’s leadership experience in the electrophysiology space and his impressive track record in capturing and growing market share in the U.S.  is well-aligned with our mission to bring our signal processing technology to as many hospitals as possible in the coming years. John will join Gray Fleming in helping run and grow our business while attracting additional talent to the Company,” commented Kenneth L. Londoner, Chairman and CEO of BioSig Technologies, Inc.

The PURE EP™ is an FDA 510(k) cleared non-invasive class II device that aims to drive procedural efficiency and efficacy in cardiac electrophysiology. To date, 75 physicians have completed more than 2150 patient cases with the PURE EP™ System.

Clinical data acquired by the PURE EP™ System in a multi-center study at Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Mayo Clinic Jacksonville, and Massachusetts General Hospital was recently published in the Journal of Cardiovascular Electrophysiology and is available electronically with open access via the Wiley Online Library. Study results showed 93% consensus across the blinded reviewers with a 75% overall improvement in intracardiac signal quality and confidence in interpreting PURE EP™  signals over conventional sources.

About BioSig Technologies
BioSig Technologies is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals (www.biosig.com).

The Company’s first product, PURE EP™ System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording, and storing electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory.

Forward-looking Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward- looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (ii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iii) difficulties in obtaining financing on commercially reasonable terms; (iv) changes in the size and nature of our competition; (v) loss of one or more key executives or scientists; and (vi) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

Andrew Ballou
BioSig Technologies, Inc.
Vice President, Investor Relations
55 Greens Farms Road
Westport, CT 06880
[email protected]
203-409-5444, x133

Source: BioSig Technologies, Inc.

Wednesday, March 16, 2022

PDS Biotechnology Corp (PDSB)
Phase 2 HPV Trial With PDS0101 Reaches Enrollment Milestone

PDS Biotechnology Corp operates as a clinical stage biotechnology company, principally involved in drug discovery in the United States. It is primarily engaged in the treatment of various early-stage and late-stage cancers, including head and neck cancer, prostate cancer, breast cancer, cervical cancer, anal cancer, and other cancers. Its products are based on the proprietary Versamune platform technology, which activates and directs the human immune system to unleash a powerful and targeted attack against cancer cells.

Robert LeBoyer, Vice President, Research Analyst, Life Sciences, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Phase 2 Enrollment Is On Schedule.  PDS Biotechnology has announced that the National Cancer Institute (NCI) Phase 2 trial testing PDS0101 in a triple-therapy regimen has reached the target patient enrollment in one of its two treatment arms. This trial is testing PDS0101 in combination with two immune modulating drugs in HPV-associated cancers.

PDS0101 Is Being Tested With Immune Modulators To Improve Response.  PDS0101 (Versamune-HPV16) uses the PDS Versamune technology with the HPV-16 antigen. It was designed to activate immunological pathways, stimulating an immune response against cancer cells with the human papilloma virus antigen. The trial is testing PDS0101 with two other immune modulating drugs (the bifunctional checkpoint …

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

PDS Biotech Announces Achievement of an Enrollment Objective in National Cancer Institute-Led Phase 2 Clinical Trial of PDS0101-Based Combination in Advanced HPV-Associated Cancers

Research, News, and Market Data on PDS Biotech

 

NCI achieves the enrollment objective of thirty patients in the checkpoint inhibitor refractory arm of the study

FLORHAM PARK, N.J., March 15, 2022 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing molecularly-targeted cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune^® and Infectimune™ T-cell activating technologies, today announced that the National Cancer Institute (NCI) has achieved the intended enrollment objective of 30 patients in the checkpoint inhibitor (CPI) refractory arm of the NCI-Led Phase 2 clinical trial (NCT04287868) evaluating PDS0101 (Versamune^®+HPV16mix) in combination with two investigational immune-modulating agents in advanced HPV-associated cancers. Currently, the study has enrolled 45 patients and will continue to enroll both CPI refractory and CPI naïve patients until the total enrollment of 56 is achieved.

The trial is evaluating the novel triple combination in two groups of patients. Firstly, in second line treatment of recurrent or metastatic HPV-positive cancers including anal, cervical, head and neck, penile, vaginal and vulvar cancers in patients who have not been treated with CPIs (CPI naïve) and have failed at least one standard of care therapy. Secondly, in third-line treatment of the above-listed recurrent or metastatic HPV-positive cancers in patients who have failed at least two standard of care therapies including CPI treatment (CPI refractory).

The NCI, part of the National Institutes of Health, presented highly promising preliminary efficacy and safety data from the trial at the June 2021 American Society of Clinical Oncology (ASCO) Conference. The NCI plans to present an update in the near future. It was reported earlier this year that median survival of these patients now exceeds 12 months.

“We are pleased the NCI has achieved this important milestone as CPI refractory patients with various HPV-associated cancers have very few effective treatment options and the study data have shown the potential to extend the lives of these patients,” commented Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. “All of us at PDS Biotech would like to thank the NCI for all of their efforts in the achievement of this enrollment objective.” 

For patients interested in enrolling in this clinical study, please call NCI’s toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615), email [email protected], and/or visit the website: https://trials.cancer.gov.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune^® and Infectimune™ T-cell activating technology platforms.

Our Versamune^®-based molecularly targeted products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune^® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate, and ovarian cancers. 

Our Infectimune™-based vaccines have demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T-cell responses including long-lasting memory T-cell responses. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

Forward Looking Statements

This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance,” “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune^® based products; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune^® based products and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the acceptance by the market of the Company’s product candidates, if approved; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company’s product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company’s annual and periodic reports filed with the SEC. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:
Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
[email protected]

PsyBio Therapeutics Announces Proposed Acquisition of Everest Pharma (Pty) Ltd., a Lesotho Company in Southern Africa, as Part of Its Ongoing Impact Investment Strategy

Research, News, and Market Data on PsyBio

 

PsyBio Therapeutics to Make Significant Environmental, Social, and Governance (ESG) Commitment to Promote Mental and Neurological Health While Working to Develop State of the Art Technologies, Process Skills and Capabilities in Lesotho and Across Africa

OXFORD, Ohio and COCONUT CREEK, Fla., March 15, 2022 /CNW/ – PsyBio Therapeutics Corp. (TSXV: PSYB) (OTCQB: PSYBF) (“PsyBio” or the “Company“), an integrated and intellectual property driven biotechnology company developing novel, bespoke psychoactive medicinal candidates targeting the potential treatment of mental health challenges, neurological disorders and other human health conditions, today announces that it has entered into a definitive agreement (the “Agreement“) to acquire all of the issued and outstanding shares of Everest Pharma (Pty) Ltd. (“Everest“), a Lesotho Company located in Southern Africa, as part of its ongoing Impact Investment Strategy (the “Acquisition“). The Acquisition will increase new research and development capabilities for PsyBio, while promoting the development of local knowledge and expertise in Lesotho. Everest is one of the select and limited companies with a psychedelic product license.

PsyBio is developing an advanced life science platform technology in the emerging psychedelic research industry. The filed intellectual property is based on producing and scaling drug candidates using genetically modified organisms. This Acquisition will add to PsyBio’s abilities which encompass fully translational capabilities in its current scientific laboratory and animal testing facilities. The PsyBio team has extensive experience in drug discovery and development based on synthetic biology, metabolic engineering, medicinal chemistry and clinical pharmacology, as well as clinical and regulatory expertise progressing drugs through human studies and governmental protocols. The team collectively has managed thousands of clinical trials and has achieved numerous regulatory approvals including therapeutics, diagnostics and devices and the Company has filed sixteen patent applications to date on its discovery accomplishments.

“Acquiring Everest is the next step of an important growth strategy for PsyBio, following the initial licensing of development technology of psychedelic compounds and their derivatives,” stated Michael Spigarelli, MD, PhD, MBA, PsyBio’s Chief Medical Officer. “The next step is for PsyBio to collaborate with Everest’s current leadership and management team to develop local scientific and manufacturing capabilities as part of our Impact Investment Strategy. This will allow for the production, licensing, sales and distribution of psycho-targeted therapeutics intended to potentially improve mental and neurological health to be undertaken not only in the United States and Europe, but also in Africa. It will also augment our research capabilities and contribute to the local health and economies of such jurisdictions.”

Upon completion of the Acquisition, PsyBio will acquire Everest’s active License to Trade covering a portfolio of: growing of spices, aromatics, drugs, and pharmaceutical crops; manufacture of pharmaceuticals, medicinal chemical and botanical products; retail sale of pharmaceutical and medical goods, cosmetic and toilet articles in specialized stores, as well as other topics covered under its general business of growing, cultivating and exporting psilocybin mushrooms and resins.

“The opportunity to demonstrate our environmental, social, and governance commitments while we produce readily manufacturable psycho-targeted therapeutic candidates, furthers PsyBio’s role as one of the only biotechnology companies in the psychoactive therapeutic industry developing its own compounds,” stated Evan Levine, PsyBio’s Chief Executive Officer. “The ability to help committed and talented local individuals develop their skills and provide for their families and extended communities fits well within our impact investment objectives and we are extremely excited to see this type of expansion continue forward once the Acquisition closes.”

The aggregate consideration paid by the Company pursuant to the Agreement includes: (i) US$100,000; and (ii) 2,100,000 subordinate voting shares of the Company (the “SVS“), at a deemed issuance price of C$0.14 per SVS. In addition, PsyBio has agreed to pay the seller rent in the amount of US$30,000 per annum for rental of the facilities currently used by Everest, and US$30,000 per annum for consulting fees. Closing of the Acquisition is expected to occur on or about March 31, 2022, and is subject to certain conditions including, but not limited to, the approval of regulatory authorities, including the TSX Venture Exchange (“TSXV“).

About PsyBio Therapeutics Corp.

PsyBio Therapeutics is fully integrated and intellectual property driven biotechnology company developing novel psychoactive medicinal candidates produced by genetically modified organisms targeting the potential treatment of mental health challenges, neurological disorders, and other human health conditions. The team has extensive experience in drug discovery based on synthetic biology and metabolic engineering as well as clinical and regulatory expertise progressing drugs through human studies and regulatory protocols. Research and development activities are currently ongoing for naturally occurring psychoactive tryptamines originally discovered in different varieties of hallucinogenic mushrooms, other tryptamines and phenethylamines and combinations thereof. The Company utilizes a bio-medicinal chemistry approach to therapeutic development, in which psycho-targeted compounds can be utilized as a template upon which to develop precursors and analogs, both naturally and non-naturally occurring, specifically because they are already known to have an effect within the brain.

Cautionary Note Regarding Forward-Looking Statements

This press release contains statements that constitute “forward-looking information” (“forward-looking information“) within the meaning of applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking information and are based on expectations, estimates and projections as at the date of this news release. Any statement that discusses predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as “expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”, “believes” or “intends” or variations of such words and phrases or stating that certain actions, events or results “may” or “could”, “would”, “might” or “will” be taken to occur or be achieved) are not statements of historical fact and may be forward-looking information. Forward looking-statements in this press release include statements regarding: the closing of the Acquisition; the timing of closing of the Acquisition; the anticipated benefits and implications of the Acquisition; the ability of PsyBio to increase its research and development capabilities while promoting the development of local knowledge and expertise in Lesotho; the ability of PsyBio to expand its operations beyond the United States; the ability of PsyBio to comply with local laws and regulations that may be applicable to Everest; the ability of PsyBio to develop novel formulations to potentially treat neurologic and psychologic conditions and other disorders; the ability of PsyBio to launch clinical trials; the ability of PsyBio to build its intellectual property portfolio of novel drug candidates; the ability of PsyBio to move target candidates into scaled commercial manufacturing and regulatory application; the ability to achieve cost competitive synthesis with reduced environmental impact over current production methods; and the ability of PsyBio to move target candidates into scaled commercial manufacturing and regulatory application.

In disclosing the forward-looking information contained in this press release, the Company has made certain assumptions, including that: PsyBio will be able to successfully integrate Everest as a subsidiary; PsyBio will benefit from the Acquisition; PsyBio will be successful in complying with local laws and regulations that may be applicable to Everest; PsyBio will be successful in protecting its intellectual property; PsyBio will be successful in discovering new valuable target molecules; PsyBio will be successful in obtaining Investigational New Drug Applications and will be able to obtain all necessary approvals for clinical trials; PsyBio will be successful in launching clinical trials; the results of preclinical safety and efficacy testing will be favorable; PsyBio’s technology will be safe and effective; a confirmed signal will be identified in PsyBio’s selected indications; and that drug development involves long lead times, is very expensive and involves many variables of uncertainty. Although the Company believes that the expectations reflected in such forward-looking information are reasonable, it can give no assurance that the expectations of any forward-looking information will prove to be correct. Known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking information. Such factors include, but are not limited to: compliance with extensive government regulations; domestic and foreign laws and regulations adversely affecting PsyBio’s business and results of operations; decreases in the prevailing process for psilocybin and nutraceutical products in the markets in which PsyBio operates; the impact of COVID-19; and general business, economic, competitive, political and social uncertainties. Accordingly, readers should not place undue reliance on the forward-looking information contained in this press release. Except as required by law, the Company disclaims any intention and assumes no obligation to update or revise any forward-looking information to reflect actual results, whether as a result of new information, future events, changes in assumptions, changes in factors affecting such forward-looking information or otherwise.

PsyBio makes no medical, treatment or health benefit claims about PsyBio’s proposed products. The U.S. Food and Drug Administration (“FDA“) or other similar regulatory authorities have not evaluated claims regarding psilocybin and other next generation psychoactive compounds. The efficacy of such products has not been confirmed by FDA-approved research. There is no assurance that the use of psilocybin and other psychoactive compounds can diagnose, treat, cure, or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. PsyBio has not conducted clinical trials for the use of its intellectual property. Any references to quality, consistency, efficacy and safety of potential products do not imply that PsyBio verified such in clinical trials or that PsyBio will complete such trials. If PsyBio cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the PsyBio’s performance and operations.

The TSXV has neither approved nor disapproved the contents of this news release. Neither the TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release.

SOURCE PsyBio Therapeutics Corp.

PsyBio Therapeutics Announces Proposed Acquisition of Everest Pharma (Pty) Ltd., a Lesotho Company in Southern Africa, as Part of Its Ongoing Impact Investment Strategy

Research, News, and Market Data on PsyBio

 

PsyBio Therapeutics to Make Significant Environmental, Social, and Governance (ESG) Commitment to Promote Mental and Neurological Health While Working to Develop State of the Art Technologies, Process Skills and Capabilities in Lesotho and Across Africa

OXFORD, Ohio and COCONUT CREEK, Fla., March 15, 2022 /CNW/ – PsyBio Therapeutics Corp. (TSXV: PSYB) (OTCQB: PSYBF) (“PsyBio” or the “Company“), an integrated and intellectual property driven biotechnology company developing novel, bespoke psychoactive medicinal candidates targeting the potential treatment of mental health challenges, neurological disorders and other human health conditions, today announces that it has entered into a definitive agreement (the “Agreement“) to acquire all of the issued and outstanding shares of Everest Pharma (Pty) Ltd. (“Everest“), a Lesotho Company located in Southern Africa, as part of its ongoing Impact Investment Strategy (the “Acquisition“). The Acquisition will increase new research and development capabilities for PsyBio, while promoting the development of local knowledge and expertise in Lesotho. Everest is one of the select and limited companies with a psychedelic product license.

PsyBio is developing an advanced life science platform technology in the emerging psychedelic research industry. The filed intellectual property is based on producing and scaling drug candidates using genetically modified organisms. This Acquisition will add to PsyBio’s abilities which encompass fully translational capabilities in its current scientific laboratory and animal testing facilities. The PsyBio team has extensive experience in drug discovery and development based on synthetic biology, metabolic engineering, medicinal chemistry and clinical pharmacology, as well as clinical and regulatory expertise progressing drugs through human studies and governmental protocols. The team collectively has managed thousands of clinical trials and has achieved numerous regulatory approvals including therapeutics, diagnostics and devices and the Company has filed sixteen patent applications to date on its discovery accomplishments.

“Acquiring Everest is the next step of an important growth strategy for PsyBio, following the initial licensing of development technology of psychedelic compounds and their derivatives,” stated Michael Spigarelli, MD, PhD, MBA, PsyBio’s Chief Medical Officer. “The next step is for PsyBio to collaborate with Everest’s current leadership and management team to develop local scientific and manufacturing capabilities as part of our Impact Investment Strategy. This will allow for the production, licensing, sales and distribution of psycho-targeted therapeutics intended to potentially improve mental and neurological health to be undertaken not only in the United States and Europe, but also in Africa. It will also augment our research capabilities and contribute to the local health and economies of such jurisdictions.”

Upon completion of the Acquisition, PsyBio will acquire Everest’s active License to Trade covering a portfolio of: growing of spices, aromatics, drugs, and pharmaceutical crops; manufacture of pharmaceuticals, medicinal chemical and botanical products; retail sale of pharmaceutical and medical goods, cosmetic and toilet articles in specialized stores, as well as other topics covered under its general business of growing, cultivating and exporting psilocybin mushrooms and resins.

“The opportunity to demonstrate our environmental, social, and governance commitments while we produce readily manufacturable psycho-targeted therapeutic candidates, furthers PsyBio’s role as one of the only biotechnology companies in the psychoactive therapeutic industry developing its own compounds,” stated Evan Levine, PsyBio’s Chief Executive Officer. “The ability to help committed and talented local individuals develop their skills and provide for their families and extended communities fits well within our impact investment objectives and we are extremely excited to see this type of expansion continue forward once the Acquisition closes.”

The aggregate consideration paid by the Company pursuant to the Agreement includes: (i) US$100,000; and (ii) 2,100,000 subordinate voting shares of the Company (the “SVS“), at a deemed issuance price of C$0.14 per SVS. In addition, PsyBio has agreed to pay the seller rent in the amount of US$30,000 per annum for rental of the facilities currently used by Everest, and US$30,000 per annum for consulting fees. Closing of the Acquisition is expected to occur on or about March 31, 2022, and is subject to certain conditions including, but not limited to, the approval of regulatory authorities, including the TSX Venture Exchange (“TSXV“).

About PsyBio Therapeutics Corp.

PsyBio Therapeutics is fully integrated and intellectual property driven biotechnology company developing novel psychoactive medicinal candidates produced by genetically modified organisms targeting the potential treatment of mental health challenges, neurological disorders, and other human health conditions. The team has extensive experience in drug discovery based on synthetic biology and metabolic engineering as well as clinical and regulatory expertise progressing drugs through human studies and regulatory protocols. Research and development activities are currently ongoing for naturally occurring psychoactive tryptamines originally discovered in different varieties of hallucinogenic mushrooms, other tryptamines and phenethylamines and combinations thereof. The Company utilizes a bio-medicinal chemistry approach to therapeutic development, in which psycho-targeted compounds can be utilized as a template upon which to develop precursors and analogs, both naturally and non-naturally occurring, specifically because they are already known to have an effect within the brain.

Cautionary Note Regarding Forward-Looking Statements

This press release contains statements that constitute “forward-looking information” (“forward-looking information“) within the meaning of applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking information and are based on expectations, estimates and projections as at the date of this news release. Any statement that discusses predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as “expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”, “believes” or “intends” or variations of such words and phrases or stating that certain actions, events or results “may” or “could”, “would”, “might” or “will” be taken to occur or be achieved) are not statements of historical fact and may be forward-looking information. Forward looking-statements in this press release include statements regarding: the closing of the Acquisition; the timing of closing of the Acquisition; the anticipated benefits and implications of the Acquisition; the ability of PsyBio to increase its research and development capabilities while promoting the development of local knowledge and expertise in Lesotho; the ability of PsyBio to expand its operations beyond the United States; the ability of PsyBio to comply with local laws and regulations that may be applicable to Everest; the ability of PsyBio to develop novel formulations to potentially treat neurologic and psychologic conditions and other disorders; the ability of PsyBio to launch clinical trials; the ability of PsyBio to build its intellectual property portfolio of novel drug candidates; the ability of PsyBio to move target candidates into scaled commercial manufacturing and regulatory application; the ability to achieve cost competitive synthesis with reduced environmental impact over current production methods; and the ability of PsyBio to move target candidates into scaled commercial manufacturing and regulatory application.

In disclosing the forward-looking information contained in this press release, the Company has made certain assumptions, including that: PsyBio will be able to successfully integrate Everest as a subsidiary; PsyBio will benefit from the Acquisition; PsyBio will be successful in complying with local laws and regulations that may be applicable to Everest; PsyBio will be successful in protecting its intellectual property; PsyBio will be successful in discovering new valuable target molecules; PsyBio will be successful in obtaining Investigational New Drug Applications and will be able to obtain all necessary approvals for clinical trials; PsyBio will be successful in launching clinical trials; the results of preclinical safety and efficacy testing will be favorable; PsyBio’s technology will be safe and effective; a confirmed signal will be identified in PsyBio’s selected indications; and that drug development involves long lead times, is very expensive and involves many variables of uncertainty. Although the Company believes that the expectations reflected in such forward-looking information are reasonable, it can give no assurance that the expectations of any forward-looking information will prove to be correct. Known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking information. Such factors include, but are not limited to: compliance with extensive government regulations; domestic and foreign laws and regulations adversely affecting PsyBio’s business and results of operations; decreases in the prevailing process for psilocybin and nutraceutical products in the markets in which PsyBio operates; the impact of COVID-19; and general business, economic, competitive, political and social uncertainties. Accordingly, readers should not place undue reliance on the forward-looking information contained in this press release. Except as required by law, the Company disclaims any intention and assumes no obligation to update or revise any forward-looking information to reflect actual results, whether as a result of new information, future events, changes in assumptions, changes in factors affecting such forward-looking information or otherwise.

PsyBio makes no medical, treatment or health benefit claims about PsyBio’s proposed products. The U.S. Food and Drug Administration (“FDA“) or other similar regulatory authorities have not evaluated claims regarding psilocybin and other next generation psychoactive compounds. The efficacy of such products has not been confirmed by FDA-approved research. There is no assurance that the use of psilocybin and other psychoactive compounds can diagnose, treat, cure, or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. PsyBio has not conducted clinical trials for the use of its intellectual property. Any references to quality, consistency, efficacy and safety of potential products do not imply that PsyBio verified such in clinical trials or that PsyBio will complete such trials. If PsyBio cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the PsyBio’s performance and operations.

The TSXV has neither approved nor disapproved the contents of this news release. Neither the TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release.

SOURCE PsyBio Therapeutics Corp.

Filament Health CEO Ben Lightburn provides a preview of their upcoming presentation at NobleCon18 NobleCon18 – Noble Capital Markets 18th Annual Small and Microcap Investor Conference – April 19-21, 2022 – Hard Rock, Hollywood, FL 100+ Public Company Presentations | Scheduled Breakouts | Panel Presentations | High-Profile Keynotes | Educational Sessions | Receptions & Networking Events Free Registration Available – More Info Research, News, and Advanced Market Data on FLHLF About Filament Health Filament Health is a clinical-stage natural psychedelic drug development company. We believe that safe, standardized, naturally-derived psychedelic medicines can improve the lives of many, and our mission is to see them in the hands of everyone who needs them as soon as possible. Filament’s platform of proprietary intellectual property enables the discovery, development, and delivery of natural psychedelic medicines for clinical development. We are paving the way with the first-ever natural psychedelic drug candidates.

PDS Biotech Announces Achievement of an Enrollment Objective in National Cancer Institute-Led Phase 2 Clinical Trial of PDS0101-Based Combination in Advanced HPV-Associated Cancers

Research, News, and Market Data on PDS Biotech

 

NCI achieves the enrollment objective of thirty patients in the checkpoint inhibitor refractory arm of the study

FLORHAM PARK, N.J., March 15, 2022 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing molecularly-targeted cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune^® and Infectimune™ T-cell activating technologies, today announced that the National Cancer Institute (NCI) has achieved the intended enrollment objective of 30 patients in the checkpoint inhibitor (CPI) refractory arm of the NCI-Led Phase 2 clinical trial (NCT04287868) evaluating PDS0101 (Versamune^®+HPV16mix) in combination with two investigational immune-modulating agents in advanced HPV-associated cancers. Currently, the study has enrolled 45 patients and will continue to enroll both CPI refractory and CPI naïve patients until the total enrollment of 56 is achieved.

The trial is evaluating the novel triple combination in two groups of patients. Firstly, in second line treatment of recurrent or metastatic HPV-positive cancers including anal, cervical, head and neck, penile, vaginal and vulvar cancers in patients who have not been treated with CPIs (CPI naïve) and have failed at least one standard of care therapy. Secondly, in third-line treatment of the above-listed recurrent or metastatic HPV-positive cancers in patients who have failed at least two standard of care therapies including CPI treatment (CPI refractory).

The NCI, part of the National Institutes of Health, presented highly promising preliminary efficacy and safety data from the trial at the June 2021 American Society of Clinical Oncology (ASCO) Conference. The NCI plans to present an update in the near future. It was reported earlier this year that median survival of these patients now exceeds 12 months.

“We are pleased the NCI has achieved this important milestone as CPI refractory patients with various HPV-associated cancers have very few effective treatment options and the study data have shown the potential to extend the lives of these patients,” commented Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. “All of us at PDS Biotech would like to thank the NCI for all of their efforts in the achievement of this enrollment objective.” 

For patients interested in enrolling in this clinical study, please call NCI’s toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615), email [email protected], and/or visit the website: https://trials.cancer.gov.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer and infectious disease immunotherapies based on the Company’s proprietary Versamune^® and Infectimune™ T-cell activating technology platforms.

Our Versamune^®-based molecularly targeted products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune^® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The Company’s pipeline products address various cancers including HPV16-associated cancers (anal, cervical, head and neck, penile, vaginal, vulvar) and breast, colon, lung, prostate, and ovarian cancers. 

Our Infectimune™-based vaccines have demonstrated the potential to induce not only robust and durable neutralizing antibody responses, but also powerful T-cell responses including long-lasting memory T-cell responses. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

Forward Looking Statements

This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance,” “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune^® based products; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101, PDS0203 and other Versamune^® based products and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including our ability to fully fund our disclosed clinical trials, which assumes no material changes to our currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the acceptance by the market of the Company’s product candidates, if approved; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company’s product candidates; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control, including unforeseen circumstances or other disruptions to normal business operations arising from or related to COVID-19. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company’s annual and periodic reports filed with the SEC. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:
Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
[email protected]

Tuesday, March 15, 2022

Ayala Pharmaceuticals (AYLA)
Buying Opportunity With Clinical Trial Milestones Ahead

Ayala Pharmaceuticals Inc clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations. The company’s current portfolio of product candidates, AL101 and AL102, targets the aberrant activation of the Notch pathway with gamma secretase inhibitors. Its product candidate, AL101, is being developed as a potent, selective, injectable small molecule gamma secretase inhibitor, or GSI. It is also developing AL101 for the treatment of T-ALL, an aggressive, rare form of T-cell specific leukemia.

Robert LeBoyer, Vice President, Research Analyst, Life Sciences, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Ayala Is Developing Drugs To Block Activation Of The Notch Pathway.  Under normal conditions, the Notch pathway provides signals that regulate cell growth and maintenance. Mutations in the Notch pathway can lead to loss of regulation and proliferation of cancerous cells. Ayala has developed drugs that block gamma secretase, an enzyme that activates the Notch pathway.

AL102 and AL102 Act By Inhibiting An Activation Step In The Notch Pathway.  Ayala has developed AL101 and AL102, two drugs that block gamma secretase, an enzyme needed to activate the Notch pathway. This stops the signaling steps that lead to overactivity and proliferation of cancer cells …

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Tonix Pharmaceuticals Reports Fourth Quarter and Full Year 2021 Financial Results and Operational Highlights

Research, News, and Market Data on Tonix Pharmaceuticals

 

Immunology and CNS Programs Entering the Clinic in 2022 for Organ Transplantation, Cocaine Intoxication, Fibromyalgia, PTSD, Migraine Headache and Binge Eating Disorder

Covid-19 Programs Include Upcoming Phase 2 Trial in Long Covid, Results of First-in-Human T Cell Immunity Skin Test and New Versions of Our Live Virus Covid-19 Vaccine That Express Spike Proteins From the Omicron and BA.2 Variants

Expansion of Internal Research and Development Capabilities Underway to Accelerate Infectious Disease Programs and Prepare for Future Pandemic Responses

Orphan-Drug Designation Granted for TNX-2900 (Intranasal Potentiated Oxytocin) for Prader-Willi Syndrome

Cash and Cash Equivalents Totaled Approximately $179 Million at December 31, 2021

CHATHAM, N.J., March 14, 2022 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced financial results for the fourth quarter and full year ended December 31, 2021, and provided an overview of recent operational highlights.

“2021 was an important year for Tonix as we delivered on several important milestones to advance our rich pipeline of immunology, central nervous system (CNS) and infectious disease product candidates,” said Seth Lederman, M.D., Chief Executive Officer of Tonix. “Our diversified pipeline was built through internal research and development, business development and strategic collaborations. Already in 2022, we have shared results of animal studies of monoclonal antibody TNX-1500 in organ transplantation and announced FDA’s award of Orphan-Drug designation for TNX-2900 for Prader Willi syndrome. We look forward to pharmacogenomic analyses, in conjunction with topline data, for the Phase 3 RALLY study of TNX-102 SL in fibromyalgia in the first quarter of 2022.”

Dr. Lederman continued, “Through acquisitions and the continued buildout of in-house R&D capabilities, Tonix is strengthening its capabilities to develop a broad infectious disease portfolio of product candidates, led by TNX-801 which is a live virus vaccine for smallpox and monkeypox, that is based on horsepox, which is our recombinant pox virus platform (RPV). Also based on the RPV are next-generation vaccine candidates to prevent Covid-19, including TNX-1840 and TNX-1850 which are live virus vaccines designed to express the omicron and BA.2 variants of the spike protein. We look forward to starting a Phase 2 study of TNX-102 SL for Long Covid and reporting topline data from the ongoing first-in-human study of TNX-2100, a diagnostic skin test for T cell immunity to SARS-CoV-2, in the first half of 2022.”

Gregory Sullivan, M.D., Chief Medical Officer of Tonix said, “In 2022, we expect to initiate several clinical trials. We intend to start a Phase 1 study of TNX-1500, a humanized monoclonal antibody with several potential indications including the prevention of organ transplant rejection and treatment of autoimmune disorders. Within our CNS pipeline, we expect to start a Phase 2 study of FDA Breakthrough Therapy-designated product candidate TNX-1300 (recombinant cocaine esterase) for cocaine intoxication in the emergency room setting. We also expect to start three trials for TNX-102 SL (sublingual cyclobenzaprine) including: a confirmatory Phase 3 study for the management of fibromyalgia, a Phase 2 study for the treatment of PTSD, and a Phase 2 study for the treatment of Long Covid. Finally, in 2022 we intend to start a Phase 2 study of TNX-1900 for the treatment of migraine and an investigator-initiated Phase 2 study of TNX-1900 for binge eating disorder.”

Recent Highlights—Key Product Candidates*

Immunology Pipeline

TNX-1500 (anti-CD40L monoclonal antibody): third generation monoclonal antibody for prophylaxis of organ transplant rejection and treating autoimmune disorders.

• Tonix expects to start a Phase 1 study in the second half of 2022. Preliminary results from ongoing experiments in heart and kidney transplants in non-human primates at Massachusetts General Hospital indicate that TNX-1500 appears to have monotherapy efficacy in promoting rejection-free transplant organ acceptance and no evidence of thrombosis has been observed.
  

TNX-1700 (stabilized recombinant trefoil factor 2, or rTFF2): biologic for gastric and colorectal cancers

• In December 2021, Tonix announced a research collaboration with Columbia University focused on advancing TNX-1700 in the treatment of gastric and colorectal cancers. Tonix optioned worldwide rights to develop and commercialize products related to Columbia’s rTFF2 technology, and key patent claims have recently been issued in the U.S. The new project, “Development of rTFF2-Based Therapy to Enhance Immuno-Oncology Treatments,” is the first sponsored research project of this collaboration. The agreement with Columbia University gives Tonix the option to exclusively license new therapeutic candidates and other technologies that arise from the research collaboration for further development. TNX-1700 is in the preclinical stage of development.
  

Central Nervous System (CNS) Pipeline

TNX-1300 (recombinant double mutant cocaine esterase): biologic for life-threatening cocaine intoxication

• Tonix expects to initiate a Phase 2 open-label safety study of TNX-1300 in an emergency room setting in the first half of 2022. TNX-1300 was licensed from Columbia University and a positive Phase 2a study of volunteer cocaine users in a controlled laboratory setting has been completed. TNX-1300 has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA).
  

TNX-102 SL (cyclobenzaprine HCl sublingual tablets): small molecule for the management of fibromyalgia (FM)

• Tonix expects to report topline data from its second Phase 3 study, RALLY, in the first quarter of 2022. Tonix reported interim analysis of RALLY in July 2021 in which the independent data monitoring committee recommended stopping the study for futility. The Company therefore stopped enrollment of new participants while continuing those participating at that time to completion. Tonix plans to employ pharmacogenomic (PGx) techniques to compare the RALLY and RELIEF study populations, which may provide a path to precision medicine-based companion diagnostics for TNX-102 SL in FM.
  
  
• Tonix expects to initiate a new Phase 3 study of TNX-102 SL in FM in the first half of 2022. The Company will use the results of RALLY, including the PGx data, to potentially improve the design of this study.
  
  
• Tonix reported positive results from the Phase 3 RELIEF study for the management of fibromyalgia in December 2020.
  

TNX-102 SL for the treatment of Posttraumatic Stress Disorder (PTSD)

• Tonix has completed a meeting with the FDA to discuss potential new endpoints for the treatment of PTSD and expects to begin enrolling a Phase 2 study of TNX-102 SL in police in Kenya in the first half of 2022. The new PTSD study will use one month look-back CAPS-5 as the primary endpoint rather than one week look-back.
  

TNX-102 SL for the treatment of Long Covid, also known as Post-Acute Sequelae of COVID-19 (PASC)

• The Company intends to initiate a Phase 2 study in patients with Long Covid in the first half of 2022, pending clearance of an Investigational New Drug (IND) application. The Phase 2 study will focus on a subset of Long Covid patients whose symptoms overlap with those of fibromyalgia.
  

TNX-1900 (intranasal potentiated oxytocin): small peptide for migraine, craniofacial pain, insulin resistance and related disorders, and binge eating disorder

• In November 2021, Tonix announced it received IND clearance from the FDA to support the initiation of a Phase 2 study of TNX-1900 for the prevention of migraine headache in chronic migraineurs. The 505(b)(2) pathway for FDA approval is expected to be acceptable for this program, which is available to new formulations of an approved drug. The Company expects to begin enrollment in the second half of 2022.
  
  
• In March 2022, Tonix announced an agreement with Massachusetts General Hospital to evaluate TNX-1900 in an investigator-initiated Phase 2 clinical trial as a potential treatment for patients with binge eating disorder. The Phase 2 clinical trial is expected to start in the second half of 2022.
  
  
• Tonix’s potentiated formulation includes magnesium (Mg), which has been reported to potentiate the binding of oxytocin to the oxytocin receptor. Further evidence for the role of Mg in potentiating the effects of oxytocin at the oxytocin receptor were published by a third party¹.
  

TNX-2900 (intranasal potentiated oxytocin): small peptide for the treatment of Prader-Willi syndrome (PWS)

• In March 2022, the FDA granted the Company Orphan-Drug designation for TNX-2900 for the treatment of PWS.
• In February 2022, Tonix entered into a sponsored research agreement with Inserm (the French National Institute of Health and Medical Research) and Aix-Marseille Université to study oxytocin in the genetically engineered mouse model of Prader-Willi syndrome, a rare genetic disorder that causes distinct, but related pathological eating disorders in adults and newborns. In adults, PWS causes hyperphagia, or pathological over-eating, which leads to obesity and other complications associated with significant mortality. In newborns, PWS causes a deficiency in suckling, which can lead to low muscle tone and failure to thrive, and has been shown to be normalized by oxytocin treatment.

TNX-601 CR (tianeptine oxalate and naloxone controlled-release tablets): small molecule for the treatment of major depressive disorder, PTSD and neurocognitive dysfunction associated with corticosteroid use.

• Based on official minutes from a pre-IND meeting with the FDA, the Company expects to initiate a Phase 2 study for the treatment of major depressive disorder (depression) in the first quarter of 2023. Tonix plans to initiate a pharmacokinetic study in the third quarter of 2022. Tonix previously completed a Phase 1 trial for formulation development outside of the U.S.
  

Infectious Disease Pipeline

TNX-801 (live horsepox virus vaccine for percutaneous administration): smallpox and monkeypox vaccine designed as a single-administration vaccine to elicit T cell immunity

• Tonix previously reported protection of non-human primates from a monkeypox challenge². TNX-801 is less virulent than traditional vaccinia vaccines in mice.³
  

TNX-1840 /-1850 (live virus vaccines based on Tonix’s recombinant pox virus vector): COVID-19 vaccines designed as a single-administration vaccine to elicit T cell immunity

• Because the omicron variant has out-competed the ancestral Wuhan strain, Tonix is now planning new versions of the TNX-1800 vaccine: TNX-1840 and TNX-1850, that are designed to express spike protein from the omicron and BA.2 variants, respectively. TNX-1840 and TNX-1850 are next-generation COVID-19 vaccines using live virus technology, which is known to primarily elicit a T cell response believed to result in longer durability and the blocking of forward transmission.
  

TNX-3500 (sangivamycin): antiviral inhibitor of SARS-CoV-2 for the treatment of COVID-19 and potential other viral disorders

• In November 2021, Tonix announced the publication of “Sangivamycin is highly effective against SARS-CoV-2 in vitro and has favorable drug properties,” in JCI Insight. The paper includes in vitro studies conducted by the National Institutes of Allergy and Infectious Diseases that show sangivamycin, the active pharmaceutical ingredient in TNX-3500, is a potent antiviral against SARS-CoV-2, the cause of COVID-19, and suppresses viral replication in tissue culture with greater potency than remdesivir, the active pharmaceutical ingredient of Gilead Sciences, Inc.’s Veklury®. When tested in combination with remdesivir, both drugs had additive rather than competitive effect against SARS-CoV-2.
  
  
• Tonix plans to conduct further nonclinical animal studies of TNX-3500.
  

TNX-3600: COVID-19 therapeutic; fully human monoclonal antibody platform

• In September 2021, Tonix expanded its research collaboration with Columbia University focused on studying immune responses to COVID-19 in healthy volunteers who have recovered from COVID-19 or were asymptomatic, as well as studying in vitro T cell and antibody responses to SARS-CoV-2, the virus that causes COVID-19. The research is designed to fill in important gaps in comprehensive understanding of immune responses to COVID-19, and to provide a foundation for tailoring vaccines and therapeutics to appropriate individuals with precision medicine. Specifically, the researchers will study T cell and antibody responses in a variety of ways, including at the cellular level by stimulating T cells in vitro with CoV-2 antigens and by generating fully human monoclonal antibodies against SARS-CoV-2. Tonix believes that this research has the potential to lead to the isolation, characterization and cloning of therapeutically relevant fully human neutralizing monoclonal antibodies to SARS-CoV-2.
  

TNX-3700: COVID-19 mRNA vaccine candidate using a zinc nanoparticle (ZNP) formulation

• In January 2022, Tonix announced an exclusive option and research collaboration with Kansas State University (K-State) to develop ZNP mRNA vaccines that replace the lipid nanoparticle (LNP) technology in current COVID-19 vaccines. The new ZNP technology has the potential to confer increased stability to mRNA vaccines over a wide range of temperatures, addressing limits to rapid global deployment. Under the research agreement, K-State will advance preclinical development of a new ZNP mRNA vaccine to protect against COVID-19 based on the spike protein from SARS-CoV-2.
  

TNX-2100 (diagnostic skin test): SARS-CoV-2 epitope peptide mixtures for intradermal administration to measure the delayed-type hypersensitivity (DTH) reaction to SARS-CoV-2

• Tonix initiated enrollment in a first-in-human, dose-finding clinical study for TNX-2100, which is designed to measure functional in vivo T cell immunity to SARS-CoV-2, with results expected in the first half of 2022.
• TNX-2100 comprises three different mixtures of synthetic peptides (TNX-2110, -2120 and -2130), which has the potential to serve as: 1) a biomarker for T cell protective immunity and durability of vaccine protection; 2) a personalized approach for vaccine boosters; 3) a method to stratify participants in COVID-19 vaccine trials with a more complete picture of immune status; 4) an endpoint in COVID-19 vaccine trials for vaccines that elicit T cell immunity, and 5) public health surveillance.

*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

2021 Highlights—Facilities and Corporate

• In December 2021, Tonix was added to the Nasdaq Biotechnology Index as part of Nasdaq’s annual reconstitution process.
  
  
• In June 2021, Tonix was added to the broad-market Russell 3000® index and the small-cap Russell 2000® Index as part of the annual reconstitution of the Russell stock indexes.
  
  
• R&D Center (RDC): In October 2021, Tonix completed the acquisition of its 48,000 square foot research and development center (RDC) in Frederick, Md. The facility is operational and will focus on the development of vaccines and antiviral drugs against COVID-19, its variants, and other infectious diseases. The RDC facility is currently biosafety level 2 (BSL-2), but Tonix plans to make appropriate upgrades and seek certification for BSL-3 so that research may be conducted on live SARS-CoV-2 and other pathogens.
  
  
• Advanced Development Center (ADC): In August 2021, Tonix commenced construction on the ADC for the development and manufacturing of Good Manufacturing Practice, or GMP, live-virus vaccines to support Phase 1 and 2 clinical trials. The facility, located in the New Bedford Business Park in Dartmouth, Mass., is planned to be BSL-2 and expected to be partially operational in the first half of 2022.
  
  
• Commercial Manufacturing Center (CMC): Tonix plans to build the CMC in Hamilton, Mont. where it purchased approximately 44 acres of land. The CMC will focus on developing and manufacturing commercial scale live-virus vaccines and is also intended to be BSL-2. Site enabling work is expected to be initiated for the CMC in 2022.

¹Meyerowitz, J.G., Robertson, M.J., Barros-Álvarez, X. et al. The oxytocin signaling complex reveals a molecular switch for cation dependence. Nat Struct Mol Biol (2022). https://doi.org/10.1038/s41594-022-00728-4
²Noyce, RS, et al. Synthetic Chimeric Horsepox Virus (scHPXV) Vaccination Protects Macaques from Monkeypox* Presented as a poster at the American Society of Microbiology BioThreats Conference – January 29, 2020, Arlington, VA. (https://content.equisolve.net/tonixpharma/media/10929ac27f4fb5f5204f5cf41d59a121.pdf )
³Noyce RS, et al. Construction of an infectious horsepox virus vaccine from chemically synthesized DNA fragments. PLoS One. 2018 Jan 19;13(1): e0188453.

Recent Highlights–Financial

As of December 30, 2021, Tonix had $178.7 million of cash and cash equivalents, compared to $77.1 million as of December 31, 2020. Subsequent to December 31, 2021, the Company sold 15.6 million shares of common stock in at-the-market offerings (ATM) sales under a Sales Agreement with A.G.P./Alliance Global Partners, for net proceeds of approximately $4.3 million. Additionally, the Company sold 22.0 million shares of common stock under the Purchase Agreement with Lincoln Park for net proceeds of approximately $4.5 million.

Cash used in operations was approximately $75.6 million for the full year ended December 31, 2021, compared to $48.6 million for the full year ended December 31, 2020. The increase in primarily due to an increase in research and development (R&D) and general and administrative (G&A) activities, described below.

Fourth Quarter 2021 Financial Results

R&D expenses for the fourth quarter of 2021 were $22.3 million, compared to $12.1 million for the same period in 2020. This increase is predominately due to increased clinical expenses of $1.9 million, increased manufacturing expenses of $2.1 million, non-clinical expenses of $2.4 million, employee-related expenses of $2.3 million and regulatory/legal expenses of $0.6 million. We expect R&D expenses to increase during 2022 as we move our clinical development programs forward and continue to invest in our development pipeline.

G&A expenses for the fourth quarter of 2021 were $7.3 million, compared to $4.9 million for the same period in 2020. The increase is primarily due to employee-related expenses of $1.8 million.

Net loss available to common stockholders was $29.6 million, or $0.07 per share, basic and diluted, for the fourth quarter of 2021, compared to net loss of $17.0 million, or $0.10 per share, basic and diluted, for the fourth quarter of 2020. The basic and diluted weighted average common shares outstanding for the fourth quarter of 2021 was 451,209,777, compared to 163,873,489 shares for the fourth quarter of 2020.

Full Year 2021 Financial Results

R&D expenses for full year 2021 were $68.8 million, compared to $36.2 million for the same period in 2020. This increase is predominately due to increased non-clinical expenses of $14.0 million, manufacturing expenses of $10.9 million, employee-related expenses of $5.3 million and regulatory/legal expenses of $1.9 million. We expect R&D expenses to increase during 2022 as we move our clinical development programs forward and continue to invest in our development pipeline.

G&A expenses for full year 2021 were $23.5 million, compared to $14.4 million for the same period in 2020. The increase is primarily due to employee-related expenses of $4.9 million, an increase in legal fees of $0.7 million due to increased patent prosecution costs, an increase in investor relations/public relations expenses of $0.6 million, an increase in financial reporting expenses of $1.2 million, and an increase in insurance premiums of $0.4 million.

Net loss available to common stockholders was $92.3 million, or $0.26 per share, basic and diluted, for full year 2021, compared to net loss of $52.2 million, or $0.55 per share, basic and diluted, for full year 2020. The basic and diluted weighted average common shares outstanding for full year 2021 was 360,215,323, compared to 94,591,715 shares for full year 2020.

About Tonix Pharmaceuticals Holding Corp.

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics and diagnostics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of immunology, central nervous system (CNS) and infectious disease product candidates. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including Tonix’s lead immunology candidate, TNX-1500¹, is a humanized monoclonal antibody targeting CD40 ligand being developed for the prevention of allograft rejection and the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to start in the second half of 2022. The Company’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL², (cyclobenzaprine HCl sublingual tablets), is a small molecule drug in mid-Phase 3 development for the management of fibromyalgia, with a new Phase 3 study expected to start in the first half of 2022. TNX-102 SL is also being developed to treat Long COVID, a chronic post-COVID-19 condition. Tonix expects to initiate a Phase 2 study in Long COVID in the first half of 2022. TNX-1300³ is a biologic designed to treat cocaine intoxication that is expected to start a Phase 2 trial in the first half of 2022. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox, next-generation vaccines to prevent COVID-19 and an antiviral to treat COVID-19. Tonix’s lead vaccine program is TNX-801 (live horsepox virus for percutaneous administration) for preventing smallpox and monkeypox⁴. Horsepox is also the basis for Tonix’s recombinant pox vaccine (RPV) platform. Tonix’s lead vaccine candidates for COVID-19, TNX-1840 and TNX-1850⁵, are live virus vaccines in development based on the RPV platform. Finally, TNX-3500⁶ (sangivamycin, i.v. solution) is a small molecule antiviral drug to treat acute COVID-19 and is in the pre-IND stage of development.

¹TNX-1500 is an investigational new biologic at the pre-IND stage of development and has not been approved for any indication.

²TNX-102 SL is an investigational new drug and has not been approved for any indication.

³TNX-1300 is an investigational new biologic and has not been approved for any indication.

⁴TNX-801 is an investigational new biologic at the pre-IND stage of development and has not been approved for any indication.

⁵TNX-1840 and TNX-1850 are investigational new biologics at the pre-IND stage of development and have not been approved for any indication. TNX-1840 and TNX-1850 are designed to express the spike protein of SARS-CoV-2 from omicron and BA.2 variants, respectively, based on the experience from TNX-1800, which expresses the spike protein from the ancestral Wuhan strain.

⁶TNX-3500 is an investigational new drug at the pre-IND stage of development and has not been approved for any indication.

This press release and further information about Tonix can be found at www.tonixpharma.com.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, the risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval, and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Company’s Annual Report on Form 10-K and periodic reports filed with the SEC. All Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

TONIX PHARMACEUTICALS HOLDING CORP.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited, In Thousands, Except Share and Per Share Amounts)

			Full Year Ended								Three Months Ended
			December 31,								December 31,
			2021				2020				2021				2020
Costs and expenses
Research and development		$	68,838			$	36,157			$	22,296			$	12,097
General and administrative			23,474				14,354				7,264				4,926
Total costs and expenses			92,312				50,511				29,560				17,023
Operating loss			(92,312	)			(50,511	)			(29,560	)			(17,023	)
Interest income, net			25				48				7				2
Net loss		$	(92,287	)		$	(50,463	)		$	(29,553	)		$	(17,021	)
Warrant deemed dividend			—				(451	)			—				—
Preferred stock deemed dividend			—				(1,260	)			—				—
Net loss available to common stockholders		$	(92,287	)		$	(52,174	)		$	(29,553	)		$	(17,021	)
Net loss per common share, basic and diluted		$	(0.26	)		$	(0.55	)		$	(0.07	)		$	(0.10	)
Weighted average common shares outstanding, basic and diluted			360,215,323				94,591,715				451,209,777				163,873,489

TONIX PHARMACEUTICALS HOLDING CORP.
CONSOLIDATED BALANCE SHEETS
DECEMBER 31, 2021 AND 2020
(In Thousands)

	December 31, 20211			December 31, 20201
Assets
Cash and cash equivalents	$	178,660		$	77,068
Prepaid expenses and other		10,389			10,921
Total current assets		189,049			87,989
Other non-current assets		51 ,851			10,194
Total assets	$	240,900		$	98,183
Liabilities and stockholders’ equity
Total liabilities	$	22,183		$	10,535
Stockholders’ equity		218,717			87,648
Total liabilities and stockholders’ equity	$	240,900		$	98,183

¹ The condensed consolidated balance sheets for the years ended December 31, 2021 and December 31, 2020 have been derived from the audited financial statements but do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements.

Jessica Morris (corporate)
Tonix Pharmaceuticals
[email protected]
(862) 904-8182

Olipriya Das, Ph.D. (media)
Russo Partners
[email protected]
(646) 942-5588

Peter Vozzo (investors)
ICR Westwicke
[email protected]
(443) 213-0505

Source: Tonix Pharmaceuticals Holding Corp.