ProMIS Neurosciences’ PMN310 antibody demonstrates significant cognitive benefit in a mouse model of Alzheimer’s disease

News and Market Data on ProMIS Neurosciences

 

Transgenic mouse model reflects latest scientific understanding of disease – toxic oligomers of amyloid create cognitive deficit

TORONTO, Ontario and CAMBRIDGE, Mass., March 02, 2022 (GLOBE NEWSWIRE) — ProMIS Neurosciences, Inc. (TSX: PMN) (OTCQB: ARFXF), a biotechnology company focused on the discovery and development of antibody therapeutics targeting misfolded proteins such as toxic oligomers, announced today that PMN310, its lead antibody therapeutic candidate for Alzheimer’s disease (AD), showed a significant cognitive benefit in a widely recognized animal model of AD.

The APP/L mouse is a “transgenic” model of AD in which human amyloid-beta oligomers lead to cognitive deficits. In this model, treatment with PMN310 which selectively targets toxic oligomers of amyloid-beta preserved memory using the water maze readout, to the extent that the PMN310 treated mice were indistinguishable from “non-transgenic” control mice.     

“This model closely aligns with the most current understanding of the biology of Alzheimer’s disease, that small clumps of misfolded amyloid-beta (toxic oligomers) are the most pathogenic species¹”, stated Dr. Neil Cashman, ProMIS Chief Scientific Officer. “In our opinion, studies in transgenic mouse models that focus on plaque removal or monomer depletion are not representative of human disease. Indeed, drug candidates that showed plaque reduction in animal models were disappointing in the clinic, and targeting amyloid monomers which worked in these models, universally failed in clinical trials.”

This positive result builds on earlier in vivo data for PMN310. We have previously published² on the protective activity of PMN310 in a novel object recognition model where toxic oligomers of amyloid-beta are injected in the brain of mice to create a memory deficit. In this model, co-injection of PMN310 prevented the loss of memory caused by toxic oligomers.

Commenting on today’s announcement, ProMIS Chairman and CEO, Eugene Williams stated: “The observed positive outcome with systemic administration of PMN310 is very encouraging, as PMN310 is on track for an IND filing by year end in its initial formulation for intravenous/infusion delivery. In parallel, we are also progressing a potential subcutaneous injection form of PMN310.”   

¹Cline E et al. 2018. The amyloid- oligomer hypothesis: beginning of the third decade. Journal of Alzheimer’s disease, 64, S567-S610.
²Gibbs E et al. 2019.  A rationally designed humanized antibody selective for amyloid beta oligomers in Alzheimer’s disease.  Scientific Reports 9: 9870.   https://doi.org/10.1038/s41598-019-46306-5

About ProMIS Neurosciences
ProMIS Neurosciences, Inc. is a development stage biotechnology company focused on discovering and developing antibody therapeutics selectively targeting toxic misfolded 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 computational modeling techniques. The Company applies its molecular dynamics, computational discovery platform -ProMIS™ and Collective Coordinates – to predict novel targets known as Disease Specific Epitopes on the molecular surface of misfolded proteins. 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
nick@alpineequityadv.com
Tel. 617 901-0785

The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. This information release contains certain forward-looking information. Such information involves known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by statements herein, and therefore these statements should not be read as guarantees of future performance or results. All forward-looking statements are based on the Company’s current beliefs as well as assumptions made by and information currently available to it as well as other factors. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by the Company in its public securities filings, actual events may differ materially from current expectations. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Source: ProMIS Neurosciences Inc.

ProMIS Neurosciences’ PMN310 antibody demonstrates significant cognitive benefit in a mouse model of Alzheimer’s disease

News and Market Data on ProMIS Neurosciences

 

Transgenic mouse model reflects latest scientific understanding of disease – toxic oligomers of amyloid create cognitive deficit

TORONTO, Ontario and CAMBRIDGE, Mass., March 02, 2022 (GLOBE NEWSWIRE) — ProMIS Neurosciences, Inc. (TSX: PMN) (OTCQB: ARFXF), a biotechnology company focused on the discovery and development of antibody therapeutics targeting misfolded proteins such as toxic oligomers, announced today that PMN310, its lead antibody therapeutic candidate for Alzheimer’s disease (AD), showed a significant cognitive benefit in a widely recognized animal model of AD.

The APP/L mouse is a “transgenic” model of AD in which human amyloid-beta oligomers lead to cognitive deficits. In this model, treatment with PMN310 which selectively targets toxic oligomers of amyloid-beta preserved memory using the water maze readout, to the extent that the PMN310 treated mice were indistinguishable from “non-transgenic” control mice.     

“This model closely aligns with the most current understanding of the biology of Alzheimer’s disease, that small clumps of misfolded amyloid-beta (toxic oligomers) are the most pathogenic species¹”, stated Dr. Neil Cashman, ProMIS Chief Scientific Officer. “In our opinion, studies in transgenic mouse models that focus on plaque removal or monomer depletion are not representative of human disease. Indeed, drug candidates that showed plaque reduction in animal models were disappointing in the clinic, and targeting amyloid monomers which worked in these models, universally failed in clinical trials.”

This positive result builds on earlier in vivo data for PMN310. We have previously published² on the protective activity of PMN310 in a novel object recognition model where toxic oligomers of amyloid-beta are injected in the brain of mice to create a memory deficit. In this model, co-injection of PMN310 prevented the loss of memory caused by toxic oligomers.

Commenting on today’s announcement, ProMIS Chairman and CEO, Eugene Williams stated: “The observed positive outcome with systemic administration of PMN310 is very encouraging, as PMN310 is on track for an IND filing by year end in its initial formulation for intravenous/infusion delivery. In parallel, we are also progressing a potential subcutaneous injection form of PMN310.”   

¹Cline E et al. 2018. The amyloid- oligomer hypothesis: beginning of the third decade. Journal of Alzheimer’s disease, 64, S567-S610.
²Gibbs E et al. 2019.  A rationally designed humanized antibody selective for amyloid beta oligomers in Alzheimer’s disease.  Scientific Reports 9: 9870.   https://doi.org/10.1038/s41598-019-46306-5

About ProMIS Neurosciences
ProMIS Neurosciences, Inc. is a development stage biotechnology company focused on discovering and developing antibody therapeutics selectively targeting toxic misfolded 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 computational modeling techniques. The Company applies its molecular dynamics, computational discovery platform -ProMIS™ and Collective Coordinates – to predict novel targets known as Disease Specific Epitopes on the molecular surface of misfolded proteins. 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
nick@alpineequityadv.com
Tel. 617 901-0785

The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. This information release contains certain forward-looking information. Such information involves known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by statements herein, and therefore these statements should not be read as guarantees of future performance or results. All forward-looking statements are based on the Company’s current beliefs as well as assumptions made by and information currently available to it as well as other factors. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by the Company in its public securities filings, actual events may differ materially from current expectations. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Source: ProMIS Neurosciences Inc.

Ceapro Bolsters Board of Directors with Appointment of Top Executive from Global Pharmaceutical Industry

Research, News, and Market Data on Ceapro

 

RONNIE MILLER, PRESIDENT AND CEO OF ROCHE CANADA FROM 2000-2022 RETIRING AFTER 43 YEARS OF LEADERSHIP SERVICE IN THE PHARMACEUTICAL INDUSTRY JOINS THE COMPANY’S BOARD OF DIRECTORS

EDMONTON, Alberta, March 02, 2022 (GLOBE NEWSWIRE) — Ceapro Inc. (TSX-V: CZO; OTCQX: CRPOF) (“Ceapro” or the “Company”), a growth-stage biotechnology company focused on the development and commercialization of active ingredients for healthcare and cosmetic industries, today announced the appointment of leading international pharmaceutical industry executive, Ronnie Miller, to its Board of Directors.

Glenn Rourke, MBA, Chairman of the Board, stated, “We are delighted and honored to welcome Mr. Miller to our Board of Directors. He is an accomplished global executive with exceptional leadership skills and recognized achievements at all levels in the healthcare industry. With his vast expertise and successful track record, we believe Mr. Miller is the ideal candidate to provide guidance to Ceapro’s leadership team to successfully bring it to the next level as a life sciences company.”

Mr. Miller brings more than 43 years of extensive and broad leadership experience in the pharmaceutical industry. Until March 2022, he served as President and CEO of Hoffmann-La Roche Limited (Roche Canada). In his 22-year tenure in this role, he was responsible for the growth and success of the Canadian Pharmaceuticals Division, particularly as it relates to Roche’s mandate of developing and delivering innovative healthcare solutions for Canadians. Prior to his appointment as President and CEO, Mr. Miller advanced through a series of successive sales and management positions across the industry to become the National Sales Manager for Roche in the United Kingdom in 1988 and continued to move globally as a Product Manager in Switzerland and Deputy Divisional Director of the Pharmaceutical Division in Japan. He moved back to Switzerland to head up a global product launch before returning to the UK as Pharmaceuticals Director.

In addition to managing Roche Canada where he pioneered global operating models, Mr. Miller was heavily involved in the Canadian Healthcare Ecosystem. He was re-elected as Chairman of the Board of Directors of Innovative Medicines Canada (IMC), the national association representing Canada’s research-based pharmaceutical companies, from 2019 to 2022. Additionally, he served as Chairman of the IMC Board in 2007 and has since fulfilled two subsequent terms as Past Chair. Prior to this, Mr. Miller was the Chair of the IMC Prairies Core Team and sat as Co-Chair of the Health Research Foundation. He also served on several committees including the IMC Public Affairs, Stakeholder Relations, the British Columbia Sub-Committee, and was Chair of the Federal Affairs/FPT Relations Standing Committee.

Over the course of his career some of his major accomplishments include, managing to get the Montreal Heart Institute designated as the hub for translational medicine studying cardiometabolic disease in the global network of Roche International; launching the National Artificial Intelligence Centre of Excellence to drive digital intelligence in Health in 2020; and convincing Swiss Parent Company Hoffmann-La Roche to locate its Global Pharma Technical Operations in Mississauga, Ontario; a $500 million investment.

Mr. Miller commented, “It is my great pleasure to join the Ceapro Board of Directors at this important time as the Company expands its natural ingredient product expertise into additional potential therapeutic indications. To-date the board and management team have built a solid foundation by putting all the pieces in place for long-term growth. As the Company continues to progress, I look forward to actively working alongside the team to maximize the potential and value of Ceapro.”

Gilles Gagnon, M.Sc., MBA, President and CEO of Ceapro, added, “Mr. Miller brings invaluable experience in managing and building international pharmaceutical companies and especially in developing and mentoring top talented people who fosters innovation for the benefit of patients. We firmly believe that his business acumen combined with his successful business development track record and vast industry network will prove to be invaluable as we expand our business model though the development of natural products and technology platforms into the expansive nutraceutical and pharmaceutical markets.”

With his Board appointment, Mr. Miller was granted options to get 150,000 common shares of Ceapro, each with an exercise price according to TSX-V regulations. Each grant vests in three equal installments, the first of which vests immediately with the second and third instalments vesting on the first and second anniversaries of the date of grant. Each option is exercisable, once vested, for a period of five years from the date of grant.

About Ceapro Inc.

Ceapro Inc. is a Canadian biotechnology company involved in the development of proprietary extraction technology and the application of this technology to the production of extracts and “active ingredients” from oats and other renewable plant resources. Ceapro adds further value to its extracts by supporting their use in cosmeceutical, nutraceutical, and therapeutics products for humans and animals. The Company has a broad range of expertise in natural product chemistry, microbiology, biochemistry, immunology and process engineering. These skills merge in the fields of active ingredients, biopharmaceuticals and drug-delivery solutions. For more information on Ceapro, please visit the Company’s website at www.ceapro.com.

For more information contact:

Jenene Thomas
JTC Team, LLC
Investor Relations and Corporate Communications Advisor
T (US): +1 (833) 475-8247
E: czo@jtcir.com

Source: Ceapro Inc.

Lineage Cell Therapeutics To Report Fourth Quarter And Full Year 2021 Financial Results And Provide Business Update On March 10, 2022

Research, News, and Market Data on Lineage Cell Therapeutics

 

CARLSBAD, Calif.–(BUSINESS WIRE)–Mar. 1, 2022– 

Lineage Cell Therapeutics, Inc.
 (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that it will report its fourth quarter and full year 2021 financial and operating results on 
Thursday, March 10, 2022, following the close of the 
U.S. financial markets. Lineage management will also host a conference call and webcast on 
Thursday, March 10, 2022, at 
4:30 p.m. Eastern Time/
1:30 p.m. Pacific Time to discuss its fourth quarter and full year 2021 financial and operating results and to provide a business update.

Interested parties may access the conference call by dialing (866) 888-8633 from the 
U.S. and 
Canada and (636) 812-6629 from elsewhere outside the 
U.S. and 
Canada and should request the “Lineage Cell Therapeutics Call”. A live webcast of the conference call will be available online in the Investors section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through 
March 18, 2022, by dialing (855) 859-2056 from the 
U.S. and 
Canada and (404) 537-3406 from elsewhere outside the 
U.S. and 
Canada and entering conference ID number 7718167.

About Lineage Cell Therapeutics, Inc.

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include three allogeneic (“off-the-shelf”) product candidates: (i) OpRegen^®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, which is now being developed under a worldwide collaboration with Roche and 
Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC2, an allogeneic dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(ir@lineagecell.com)
(442) 287-8963

Solebury Trout IR
Mike Biega
(Mbiega@soleburytrout.com)
(617) 221-9660

Russo Partners – Media Relations
Nic Johnson or  David Schull
Nic.johnson@russopartnersllc.com
David.schull@russopartnersllc.com
(212) 845-4242

Source: 
Lineage Cell Therapeutics, Inc.

Noble Capital Markets Senior Research Analyst Gregory Aurand sits down with Baudax Bio President & CEO Gerri Henwood for this exclusive interview. Research, News, and Advanced Market Data on BXRX View all C-Suite Interviews The 2022 C-Suite Interview series is now available on major podcast platforms About Baudax Bio Baudax Bio is a pharmaceutical company focused on commercializing and developing innovative products for acute care settings. ANJESO is the first and only 24-hour, intravenous (IV) COX-2 preferential non-steroidal anti-inflammatory (NSAID) for the management of moderate to severe pain. In addition to ANJESO, Baudax Bio has a pipeline of other innovative pharmaceutical assets including two novel neuromuscular blocking agents (NMBs) and a proprietary chemical reversal agent specific to these NMBs. For more information, please visit www.baudaxbio.com.

Lineage Cell Therapeutics To Report Fourth Quarter And Full Year 2021 Financial Results And Provide Business Update On March 10, 2022

Research, News, and Market Data on Lineage Cell Therapeutics

 

CARLSBAD, Calif.–(BUSINESS WIRE)–Mar. 1, 2022– 

Lineage Cell Therapeutics, Inc.
 (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that it will report its fourth quarter and full year 2021 financial and operating results on 
Thursday, March 10, 2022, following the close of the 
U.S. financial markets. Lineage management will also host a conference call and webcast on 
Thursday, March 10, 2022, at 
4:30 p.m. Eastern Time/
1:30 p.m. Pacific Time to discuss its fourth quarter and full year 2021 financial and operating results and to provide a business update.

Interested parties may access the conference call by dialing (866) 888-8633 from the 
U.S. and 
Canada and (636) 812-6629 from elsewhere outside the 
U.S. and 
Canada and should request the “Lineage Cell Therapeutics Call”. A live webcast of the conference call will be available online in the Investors section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through 
March 18, 2022, by dialing (855) 859-2056 from the 
U.S. and 
Canada and (404) 537-3406 from elsewhere outside the 
U.S. and 
Canada and entering conference ID number 7718167.

About Lineage Cell Therapeutics, Inc.

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include three allogeneic (“off-the-shelf”) product candidates: (i) OpRegen^®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, which is now being developed under a worldwide collaboration with Roche and 
Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC2, an allogeneic dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
(ir@lineagecell.com)
(442) 287-8963

Solebury Trout IR
Mike Biega
(Mbiega@soleburytrout.com)
(617) 221-9660

Russo Partners – Media Relations
Nic Johnson or  David Schull
Nic.johnson@russopartnersllc.com
David.schull@russopartnersllc.com
(212) 845-4242

Source: 
Lineage Cell Therapeutics, Inc.

Monday, February 28, 2022

Baudax Bio (BXRX)
Public Offering Announced; Revising EPS and Price Target

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, Noble Capital Markets, Inc.

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

Announced offering. Last Friday, Baudax Bio announced a $10 million public offering, composed of 3,508,772 shares of common stock sold together with 3,508,772 warrants allowing for the purchase of a common share at $3.25. The offering price of the stock and warrant unit is $2.85. The warrants will be exercisable immediately after the offering and expire in five years. The offering is expected to close on or about March 1, 2022.


Current market environment increases the share count.  While the capital raise was anticipated, the market environment has been decidedly unforgiving. While we believe it is unwarranted, the stock price has declined roughly 70% from where it was prior to the announced split. With the stock price decline, a greater number of shares are required to support company needs. With the weakness, the issued …

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. 

Monday, February 28, 2022

Ocugen (OCGN)
Pipeline Progress Updated With Fourth Quarter Financial Report

Ocugen Inc is a clinical stage biopharmaceutical company. It is focused on discovering, developing and commercializing a pipeline of innovative therapies that address rare and underserved eye diseases. Ocugen offers a diversified ophthalmology portfolio that includes novel gene therapies, biologics, and small molecules and targets a broad range of high-need retinal and ocular surface diseases.

Robert LeBoyer, Senior Research Analyst, Noble Capital Markets, Inc.

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

Summary.  Ocugen reported a net loss of $14.6 million or $(0.07) per share for 4Q21, bringing FY21 loss to $58.4 million or $(0.30) per share. The company also gave updates on recent developments for its development programs. Cash at December 31, 2021 was $95.1 million, excluding proceeds of an offering completed in late February 2022.


Covaxin Is Progressing Through FDA and Heath Canada.  The FDA lifted the Clinical Hold on the IND application for the Phase 2/3 clinical trial, allowing the bridging study to continue. The Emergency Use Authorization (EUA) application submitted in November 2022 has been supplemented with safety data and studies showing neutralization of the Delta and Omicron variants …

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. 

Monday, February 28, 2022

Baudax Bio (BXRX)
Public Offering Announced; Revising EPS and Price Target

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, Noble Capital Markets, Inc.

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

Announced offering. Last Friday, Baudax Bio announced a $10 million public offering, composed of 3,508,772 shares of common stock sold together with 3,508,772 warrants allowing for the purchase of a common share at $3.25. The offering price of the stock and warrant unit is $2.85. The warrants will be exercisable immediately after the offering and expire in five years. The offering is expected to close on or about March 1, 2022.


Current market environment increases the share count.  While the capital raise was anticipated, the market environment has been decidedly unforgiving. While we believe it is unwarranted, the stock price has declined roughly 70% from where it was prior to the announced split. With the stock price decline, a greater number of shares are required to support company needs. With the weakness, the issued …

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. 

Thursday, February 24, 2022

Ayala Pharmaceuticals (AYLA)
Ayala Completes Phase 2/3 Trial RINGSIDE Part A and Confirms Data Milestone

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, Senior Research Analyst, Noble Capital Markets, Inc.

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

First Stage of Phase 2/3 RINGSIDE Trial Completed Enrollment.  Ayala has announced that enrollment is complete for Part A of the Phase 2/3 RINGSIDE trial. This trial is testing the oral gamma-secretase inhibitor, AL102, in desmoid tumors. The data from this portion of the trial is expected to be announced in mid-2022, consistent with prior guidance.


Part A Is Designed To Determine Safety, Efficacy, and Dosing For Part B.  The first part of the RINGSIDE trial enrolled 36 patients to evaluate safety, tolerability, and changes in tumor volume by MRI scans. These data will be used to select the dose for Part B. A previous sub-study tested pharmacokinetics and found no food restrictions were needed …

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. 

Thursday, February 24, 2022

Stem Holdings (STMH)(STEM:CA)
Fiscal First Quarter 2022 Results

Stem Holdings Inc is engaged in the purchasing, improving, and leasing of properties and finance assets which are operated by third parties and are used for the cultivation and retail sale of marijuana. Its properties includes 42nd Street, and Mulino Farm which are used for agriculture. The company generates its revenue in the form of rental income from tenants.

Joe Gomes, Senior Research Analyst, Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

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

1QFY22 Results. Stem reported net revenue of revenue of $4.2 million compared to $5.3 million last year. The sales decline reflects a decrease in sales resulting from general market conditions. Stem reported a net loss of $4.1 million, or $0.02 per share, for the quarter, including $795,000 of non-cash impairment charges, a $1.75 million loss from discontinued operations, and a $1.7 million gain from the change in the fair value of warrant liability. In 1Q21, Stem recorded a net loss of $3.2 million, or $0.05 per share. Outstanding shares increased to 230.2 million from 69.7 million.


What’s Next? Interim CEO Hubbard continues to work through putting the Stem house in order, in our opinion, with an ultimate goal of focusing on just the California and Oregon businesses.  Ultimately, we believe Stem either needs to get bigger, which would require additional capital, or sell to a larger entity. Which way the Company will go is uncertain at this time, but we believe Stem does have …

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. 

Neovasc to Report Fourth Quarter and Full Year 2021 Financial Results on March 10, 2022

Research, News, and Market Data on Neovasc

 

VANCOUVER and MINNEAPOLIS – ( NewMediaWire ) – February 24, 2022 – Neovasc Inc. ( NASDAQ ,  TSX : NVCN), will report financial results for the quarter and full year ended December 31, 2021 on Thursday, March 10, 2022. Neovasc’s President and Chief Executive Officer Fred Colen, and Chris Clark, Chief Financial Officer, will host a conference call to review the company’s results at 4:30 pm EDT on March 10, 2022.

Interested parties may access the conference call by dialing (877) 407-9208 or (201) 493-6784 (International) and reference Conference ID 13726770. Participants wishing to join the call via webcast should use the link posted on the investor relations section of the Neovasc website at  neovasc.com/investors/. A replay of the webcast will be available approximately 30 minutes after the conclusion of the call using the link on the Neovasc website.

About Neovasc Inc.

Neovasc is a specialty medical device company that develops, manufactures, and markets products for the rapidly growing cardiovascular marketplace. Its products include Reducer, for the treatment of refractory angina, which is under clinical investigation in the United States and has been commercially available in Europe since 2015, and Tiara™ for the transcatheter treatment of mitral valve disease, which is currently under clinical investigation in the United States, Canada, Israel and Europe. For more information, visit:  www.neovasc.com.

Contacts

Investors

Mike Cavanaugh
Westwicke/ICR
Phone: +1.617.877.9641
Email: Mike.Cavanaugh@westwicke.com

Media

Sean Leous
Westwicke/ICR
Phone: +1.646.866.4012
Email: Sean.Leous@icrinc.com

PDS Biotech Announces Preliminary Safety Data on PDS0101 in Combination With KEYTRUDA® (pembrolizumab) at the 2022 Multidisciplinary Head and Neck Cancers Symposium

Research, News, and Market Data on PDS Biotech

 

Preliminary safety data has shown that PDS0101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA^® (pembrolizumab) for the treatment of recurrent or metastatic HPV16-positive head and neck cancer is likely safe and well tolerated without evidence of enhanced or significant toxicity

FLORHAM PARK, N.J., Feb. 24, 2022 (GLOBE NEWSWIRE) —  PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune^® and Infectimune™ T-cell activating technology, today announced the presentation of preliminary safety data. The data are based on a total of 18 checkpoint inhibitor (CPI) naïve patients from the Company’s ongoing VERSATILE-002 Phase 2 study. The study is being conducted in collaboration with Merck (known as MSD outside the US and Canada) (NCT04260126). The data from the study will be presented at the 2022 Multidisciplinary Head and Neck Cancers Symposium.

The Phase 2 trial studies PDS0101 in combination with Merck’s anti-PD-1 therapy KEYTRUDA^® (pembrolizumab) for the treatment of recurrent or metastatic HPV16-positive head and neck cancer. The trial is designed to treat both CPI naïve and refractory patients and will assess the primary efficacy endpoint, as well as partial response per RECIST 1.1.  The Company previously announced that it had achieved its preliminary efficacy milestone in the CPI naive arm earlier this month. 

Patients in the trial are treated with KEYTRUDA^® 200 mg intravenously every three weeks plus PDS0101 delivered subcutaneously with KEYTRUDA^® on cycles of 1-4 and again at cycle 12. An initial safety cohort was assessed during cycle 1 and 21 days following for dose-limiting toxicity, and thereafter for safety and tolerability of the combination.

Highlights from the PDS Biotech’s presentation at the 2022 Multidisciplinary Head and Neck Cancers Symposium regarding the preliminary results of the Phase 2 trial studying PDS0101 in combination with KEYTRUDA for the treatment of recurrent or metastatic HPV16-positive head and neck cancer include the absence of dose-limiting toxicities, drug discontinuation related to toxicity, or immune-related adverse events. Subjects received a median of 4 doses of PDS0101 (range 1-5) and a median of 6 doses of KEYTRUDA^® (range 1-13). In addition, no treatment-related grade 3 or higher toxicities were reported.

Preliminary safety data has shown that PDS0101 in combination with KEYTRUDA^® for the treatment of recurrent or metastatic HPV16-positive head and neck cancer is likely safe and well tolerated without evidence of enhanced or significant toxicity in the first 18 patients evaluated on the study. Accrual in this study has progressed to Stage 2 for the CPI naïve cohort and is ongoing in Stage 1 for the CPI refractory cohort. The full data set can be found under abstract number 157 at the virtual poster library, here.

Receipt of preliminary results are not necessarily indicative of the final-results of the Phase 2 trial studying PDS0101 in combination with KEYTRUDA^® for the treatment of recurrent or metastatic HPV16-positive head and neck cancer.

“We are encouraged by the preliminary safety data of PDS0101 in combination with KEYTRUDA^® for patients with recurrent or metastatic HPV16-positive head and neck cancer,” commented Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. “These data and the preliminary efficacy data continue to support the unique combination of safety and potency of our novel Versamune^® platform.” 

In addition to the ongoing VERSATILE-002 Phase 2 trial, PDS Biotech is conducting another Phase 2 clinical study in both second-and third-line treatment for multiple advanced HPV-associated cancers with the National Cancer Institute (NCI) (NCT04287868). A third Phase 2 clinical trial, IMMUNOCERV (NCT04580771), in first-line treatment of locally advanced cervical cancer is being performed with The University of Texas, MD Anderson Cancer Center. In addition, the Company recently announced a fourth Phase 2 trial with Mayo Clinic to study PDS0101 with and without KEYTRUDA^® prior to surgery in locally advanced HPV-associated oropharyngeal cancer (NCT05232851). 

KEYTRUDA^® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About PDS Biotechnology

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

Our Versamune^®-based 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
pdsb@cg.capital