Ocugen, Inc. to Present at Upcoming Citi and H.C. Wainwright Investment Conferences

 

MALVERN, Pa., Sept. 07, 2021 (GLOBE NEWSWIRE) — Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to fight COVID-19, today announced that it will be participating in Citi’s 16th Annual BioPharma Virtual Conference being held on September 8-10, 2021 and at the H.C. Wainwright Global Investment Conference being held on September 13-15, 2021.

Dr. Shankar Musunuri, Chairman, CEO, and Co-Founder will present virtually at Citi’s conference and Sanjay Subramanian, CFO and Head of Corporate Development will present virtually at H.C. Wainwright. Both will provide updates on COVAXIN™, the investigational COVID-19 vaccine which the company is co-developing with Bharat Biotech for the U.S. and Canadian markets. They will also present information about Ocugen’s breakthrough modifier gene therapy platform, which has generated product candidates that are expected to enter Phase 1/2a clinical trials in ophthalmic disease states over the next 18 months.

Citi/Ocugen Fireside Chat
Date/Time: Wednesday, September 8, 2021, from 3:15PM-4:00PM Eastern Time
Registration link: https://kvgo.com/citi-16th-annual-biopharma-vc/ocugen-inc-sept-2021

H.C. Wainwright Global Investment Conference
Date/Time: Presentation available on-demand starting at 7:00AM Eastern Time on September 13, 2021
Registration link: https://journey.ct.events/view/705764c5-88a7-4a4c-afff-d1688de5a5d9

About Ocugen, Inc.
Ocugen, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug — “one to many,” and our novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. We are co-developing Bharat Biotech’s COVAXIN™ vaccine candidate for COVID-19 in the U.S. and Canadian markets. For more information, please visit www.ocugen.com. 

Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from our current expectations, such as risks and uncertainties regarding market and other conditions and the timing of our planned clinical trials. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (the “SEC”), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release. 

Ocugen Contact:
Ken Inchausti
Head, Investor Relations & Communications
IR@Ocugen.com 

New Gene Therapies May Soon Treat Dozens of Rare Diseases, but Million-Dollar Price Tags Will Put them out of Reach for Many

 

Zolgensma – which treats spinal muscular atrophy, a rare genetic disease that damages nerve cells, leading to muscle decay – is currently the most expensive drug in the world. A one-time treatment of the life-saving drug for a young child costs US$2.1 million.

While Zolgensma’s exorbitant price is an outlier today, by the end of the decade there’ll be dozens of cell and gene therapies, costing hundreds of thousands to millions of dollars for a single dose. The Food and Drug Administration predicts that by 2025 it will be approving 10 to 20 cell and gene therapies every year.

 

This article was republished with permission from  The Conversation, a news site dedicated to sharing ideas from academic experts. It represents the research-based findings and thoughts of Kevin Doxzen, Hoffmann Postdoctoral Fellow,

 

I’m a biotechnology and policy expert focused on improving access to cell and gene therapies. While these forthcoming treatments have the potential to save many lives and ease much suffering, health care systems around the world aren’t equipped to handle them. Creative new payment systems will be necessary to ensure everyone has equal access to these therapies.

The Rise of Gene Therapies

Currently, only 5% of the roughly 7,000 rare diseases have an FDA-approved drug, leaving thousands of conditions without a cure.

But over the past few years, genetic engineering technology has made impressive strides toward the ultimate goal of curing disease by changing a cell’s genetic instructions. The resulting gene therapies will be able to treat many diseases at the DNA level in a single dose.

Thousands of diseases are the result of DNA errors, which prevent cells from functioning normally. By directly correcting disease-causing mutations or altering a cell’s DNA to give the cell new tools to fight disease, gene therapy offers a powerful new approach to medicine.

There are 1,745 gene therapies in development around the world. A large fraction of this research focuses on rare genetic diseases, which affect 400 million people worldwide.

We may soon see cures for rare diseases like sickle cell disease, muscular dystrophy and progeria, a rare and progressive genetic disorder that causes children to age rapidly.

Further into the future, gene therapies may help treat more common conditions, like heart disease and chronic pain.

 

Sky-High Price Tags

The problem is these therapies will carry enormous price tags.

Gene therapies are the result of years of research and development totaling hundreds of millions to billions of dollars. Sophisticated manufacturing facilities, highly trained personnel and complex biological materials set gene therapies apart from other drugs.

Pharmaceutical companies say recouping costs, especially for drugs with small numbers of potential patients, means higher prices. The toll of high prices on health care systems will not be trivial. Consider a gene therapy cure for sickle cell disease, which is expected to be available in the next few years. The estimated price of this treatment is $1.85 million per patient. As a result, economists predict that it could cost a single state Medicare program almost $30 million per year, even assuming only 7% of the eligible population received the treatment.

And that’s just one drug. Introducing dozens of similar therapies into the market would strain health care systems and create difficult financial decisions for private insurers.

 

Lowering Costs, Finding New Ways to Pay

One solution for improving patient access to gene therapies would be to simply demand drugmakers charge less money, a tactic recently taken in Germany. But this comes with a lot of challenges and may mean that companies simply refuse to offer the treatment in certain places.

I think a more balanced and sustainable approach is two-fold. In the short term, it’ll be important to develop new payment methods that entice insurance companies to cover high-cost therapies and distribute risks across patients, insurance companies and drugmakers. In the long run, improved gene therapy technology will inevitably help lower costs.

For innovative payment models, one tested approach is tying coverage to patient health outcomes. Since these therapies are still experimental and relatively new, there isn’t much data to help insurers make the risky decision of whether to cover them. If an insurance company is paying $1 million for a therapy, it had better work.

In outcomes-based models, insurers will either pay for some of the therapy upfront and the rest only if the patient improves, or cover the entire cost upfront and receive a reimbursement if the patient doesn’t get better. These models help insurers share financial risk with the drug developers.

Another model is known as the “Netflix model” and would act as a subscription-based service. Under this model, a state Medicaid program would pay a pharmaceutical company a flat fee for access to unlimited treatments. This would allow a state to provide the treatment to residents who qualify, helping governments balance their budget books while giving drugmakers money upfront.

This model has worked well for improving access to hepatitis C drugs in Louisiana.

On the cost front, the key to improving access will be investing in new technologies that simplify medical procedures. For example, the costly sickle cell gene therapies currently in clinical trials require a series of expensive steps, including a stem cell transplant.

The Bill & Melinda Gates Foundation, the National Institute of Health and Novartis are partnering to develop an alternative approach that would involve a simple injection of gene therapy molecules. The goal of their collaboration is to help bring an affordable sickle cell treatment to patients in Africa and other low-resource settings.

Improving access to gene therapies requires collaboration and compromise across governments, nonprofits, pharmaceutical companies, and insurers. Taking proactive steps now to develop innovative payment models and invest in new technologies will help ensure that health care systems are ready to deliver on the promise of gene therapies.

 

Suggested Reading:

Genetics Now Touch All Areas of Life Sciences

Small Caps in the Covid 19 Treatment Space

Are Biotech Scientists on the Road to a Cure for Type One Diabetes?

Stem Cells Role in the Anti-Aging Process

 

Stay up to date. Follow us:

Lineage Announces Appointment of General Counsel

 

CARLSBAD, Calif.–(BUSINESS WIRE)–Sep. 1, 2021– 

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 has appointed George A. Samuel III as Lineage’s General Counsel and Corporate Secretary.  Mr. Samuel will lead the Company’s legal operations, bringing extensive corporate, transactional, intellectual property and commercial expertise which spans nearly 15 years across the life sciences and technology sectors as well as in private practice.

“We are pleased to welcome George to our leadership team and look forward to his contributions as we build Lineage into a leading cell therapy and cell transplant company,” stated  Brian M. Culley, Lineage CEO. “George’s diverse experience across legal and other operational areas will be invaluable as we continue to execute on our clinical development plans. In particular, his transactional successes in business development and his intellectual property experience will be key resources as we evaluate partnership opportunities and expand collaborations for our OpRegen, OPC1 and VAC2 programs and work to unlock additional value from our extensive intellectual property portfolio.”

“I am looking forward to joining this dynamic and experienced team by leading Lineage’s legal operations at this exciting and transformative time,” stated George A. Samuel III. “The field of cell therapy is undergoing rapid growth and I’m delighted to have this opportunity to contribute to it.”

Prior to joining Lineage,  Mr. Samuel most recently served as Director, Senior Counsel for 
Lytx, Inc., where he managed the commercial legal operations for an international video telematics SaaS company. Prior to that,  Mr. Samuel served as VP, General Counsel and Corporate Secretary for Cardiff Oncology, Inc. (formerly known as 
Trovagene, Inc.), a clinical-stage biotechnology company focused on developing treatments in oncology. While at Cardiff Oncology, he advised on strategic, business development and operational decisions; oversaw capital raising efforts, regulatory compliance as well as 
SEC reporting; and managed intellectual property, including technology transfer and licensing.  Mr. Samuel has also practiced corporate law at major law firms, including 
DLA Piper LLP and 
Cooley LLP, where he served as outside counsel to public and private companies in a variety of commercial transactions.  Mr. Samuel received a J.D. from 
Columbia University School of Law, and a B.A. in Philosophy from 
Tufts University and is a member of the 
State Bar of California and 
New York.

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 three allogeneic (“off-the-shelf”) clinical programs are in markets with billion dollar opportunities: (i) OpRegen^®, an investigational retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an investigational oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC, an allogeneic dendritic cell therapy platform for immuno-oncology and infectious disease, with investigational immunotherapy VAC2 currently in 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.

Forward-Looking Statements

Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” project,” “target,” “tend to,” “look forward to” or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to Lineage’s ability to become a leading cell therapy and cell transplant company, to expand collaborations for its product candidate programs, and to unlock value from its intellectual property portfolio, and the commercial potential for cell therapy products. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the 
Securities and Exchange Commission (the 
SEC). Further information regarding these risks, uncertainties and factors is included under the heading “Risk Factors” in Lineage’s periodic and other reports filed with the 
SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, which are available from the SEC’s website. Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

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

Solebury Trout IR
Gitanjali Jain Ogawa
(Gogawa@soleburytrout.com)
(646) 378-2949

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.

ProMIS Neurosciences appoints accomplished biotechnology executive, Josh Mandel-Brehm, to its Board of Directors

 

TORONTO, Ontario and CAMBRIDGE, Massachusetts – Sept.1, 2021– ProMIS Neurosciences, Inc. (TSX: PMN); (OTCQB: ARFXF), a biotechnology company focused on the discovery and development of antibody therapeutics selectively targeting toxic oligomers implicated in the development of neurodegenerative diseases, today announced the appointment of Josh Mandel-Brehm to its Board of Directors with immediate effect. 

“I am delighted to welcome Josh Mandel-Brehm as a member of the ProMIS Board of Directors at this time”, said Eugene Williams, Executive Chairman of ProMIS Neurosciences. “Josh has built a productive platform company in CAMP4, which experience is very relevant to ProMIS and our unique platform opportunity. Combined with his tremendous background in business development, capital formation, and strategy, we believe Josh will make significant contributions to the ProMIS Board.”

“I am very pleased to join the Board of Directors of ProMIS”, stated Josh Mandel-Brehm. “PMN310 has the potential to change the lives of many patients suffering from Alzheimer’s Disease and I am especially impressed by the technology platform and the team. ProMIS is well positioned to build a portfolio of next generation, differentiated antibody-based therapeutics in neurodegenerative and other mis-folded protein diseases, an area that I expect will be of increasing interest to investors and large pharma.” 

Josh Mandel-Brehm is President & Chief Executive Officer of CAMP4 Therapeutics and holds a dual appointment as entrepreneur partner with Polaris Partners. He is also a co-founder and board member for Vico Therapeutics, an oligonucleotide-based RNA modulating Company focused on developing therapeutics for patients suffering from rare CNS disorders.

Mr. Mandel-Brehm previously held key business development and operations leadership roles at leading biotech companies. Most recently he served as part of the Business Development group at Biogen, where he led multiple strategic activities and corresponding transactions, which included expanding Biogen’s non-malignant hematology franchise, overseeing seminal investments to enter the ophthalmology field and advancing Biogen’s gene therapy strategy. Prior to Biogen, Mr. Mandel-Brehm held several roles of increasing responsibility at Genzyme as part of the business development group for the company’s rare disease business unit.

Mr. Mandel-Brehm earned a BA in Biology from Washington University in St. Louis and holds an MBA from the University of Michigan.

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
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.

ProMIS Neurosciences appoints accomplished biotechnology executive, Josh Mandel-Brehm, to its Board of Directors

 

TORONTO, Ontario and CAMBRIDGE, Massachusetts – Sept.1, 2021– ProMIS Neurosciences, Inc. (TSX: PMN); (OTCQB: ARFXF), a biotechnology company focused on the discovery and development of antibody therapeutics selectively targeting toxic oligomers implicated in the development of neurodegenerative diseases, today announced the appointment of Josh Mandel-Brehm to its Board of Directors with immediate effect. 

“I am delighted to welcome Josh Mandel-Brehm as a member of the ProMIS Board of Directors at this time”, said Eugene Williams, Executive Chairman of ProMIS Neurosciences. “Josh has built a productive platform company in CAMP4, which experience is very relevant to ProMIS and our unique platform opportunity. Combined with his tremendous background in business development, capital formation, and strategy, we believe Josh will make significant contributions to the ProMIS Board.”

“I am very pleased to join the Board of Directors of ProMIS”, stated Josh Mandel-Brehm. “PMN310 has the potential to change the lives of many patients suffering from Alzheimer’s Disease and I am especially impressed by the technology platform and the team. ProMIS is well positioned to build a portfolio of next generation, differentiated antibody-based therapeutics in neurodegenerative and other mis-folded protein diseases, an area that I expect will be of increasing interest to investors and large pharma.” 

Josh Mandel-Brehm is President & Chief Executive Officer of CAMP4 Therapeutics and holds a dual appointment as entrepreneur partner with Polaris Partners. He is also a co-founder and board member for Vico Therapeutics, an oligonucleotide-based RNA modulating Company focused on developing therapeutics for patients suffering from rare CNS disorders.

Mr. Mandel-Brehm previously held key business development and operations leadership roles at leading biotech companies. Most recently he served as part of the Business Development group at Biogen, where he led multiple strategic activities and corresponding transactions, which included expanding Biogen’s non-malignant hematology franchise, overseeing seminal investments to enter the ophthalmology field and advancing Biogen’s gene therapy strategy. Prior to Biogen, Mr. Mandel-Brehm held several roles of increasing responsibility at Genzyme as part of the business development group for the company’s rare disease business unit.

Mr. Mandel-Brehm earned a BA in Biology from Washington University in St. Louis and holds an MBA from the University of Michigan.

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
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.

Lineage Announces Appointment of General Counsel

 

CARLSBAD, Calif.–(BUSINESS WIRE)–Sep. 1, 2021– 

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 has appointed George A. Samuel III as Lineage’s General Counsel and Corporate Secretary.  Mr. Samuel will lead the Company’s legal operations, bringing extensive corporate, transactional, intellectual property and commercial expertise which spans nearly 15 years across the life sciences and technology sectors as well as in private practice.

“We are pleased to welcome George to our leadership team and look forward to his contributions as we build Lineage into a leading cell therapy and cell transplant company,” stated  Brian M. Culley, Lineage CEO. “George’s diverse experience across legal and other operational areas will be invaluable as we continue to execute on our clinical development plans. In particular, his transactional successes in business development and his intellectual property experience will be key resources as we evaluate partnership opportunities and expand collaborations for our OpRegen, OPC1 and VAC2 programs and work to unlock additional value from our extensive intellectual property portfolio.”

“I am looking forward to joining this dynamic and experienced team by leading Lineage’s legal operations at this exciting and transformative time,” stated George A. Samuel III. “The field of cell therapy is undergoing rapid growth and I’m delighted to have this opportunity to contribute to it.”

Prior to joining Lineage,  Mr. Samuel most recently served as Director, Senior Counsel for 
Lytx, Inc., where he managed the commercial legal operations for an international video telematics SaaS company. Prior to that,  Mr. Samuel served as VP, General Counsel and Corporate Secretary for Cardiff Oncology, Inc. (formerly known as 
Trovagene, Inc.), a clinical-stage biotechnology company focused on developing treatments in oncology. While at Cardiff Oncology, he advised on strategic, business development and operational decisions; oversaw capital raising efforts, regulatory compliance as well as 
SEC reporting; and managed intellectual property, including technology transfer and licensing.  Mr. Samuel has also practiced corporate law at major law firms, including 
DLA Piper LLP and 
Cooley LLP, where he served as outside counsel to public and private companies in a variety of commercial transactions.  Mr. Samuel received a J.D. from 
Columbia University School of Law, and a B.A. in Philosophy from 
Tufts University and is a member of the 
State Bar of California and 
New York.

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 three allogeneic (“off-the-shelf”) clinical programs are in markets with billion dollar opportunities: (i) OpRegen^®, an investigational retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an investigational oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC, an allogeneic dendritic cell therapy platform for immuno-oncology and infectious disease, with investigational immunotherapy VAC2 currently in 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.

Forward-Looking Statements

Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” project,” “target,” “tend to,” “look forward to” or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to Lineage’s ability to become a leading cell therapy and cell transplant company, to expand collaborations for its product candidate programs, and to unlock value from its intellectual property portfolio, and the commercial potential for cell therapy products. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the 
Securities and Exchange Commission (the 
SEC). Further information regarding these risks, uncertainties and factors is included under the heading “Risk Factors” in Lineage’s periodic and other reports filed with the 
SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, which are available from the SEC’s website. Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

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

Solebury Trout IR
Gitanjali Jain Ogawa
(Gogawa@soleburytrout.com)
(646) 378-2949

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.

Ceapro Inc. Reports 2021 Second Quarter and Six-Month Financial Results and Operational Highlights

 

– Company continues to increase R&D activities to advance clinical and preclinical programs –

– Second quarter sales of $4,409,000 compared to $4,666,000 for second quarter 2020 –

– Cash generated from operations of $2,128,000 in Q2 2021 compared to $2,195,000 in Q2 2020 –

– Maintained production operations during COVID-19 pandemic, providing customers with essential products while ensuring the health and safety of our employees –

EDMONTON, Alberta, Aug. 26, 2021 (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 financial results and operational highlights for the second quarter and six months ended June 30, 2021.

“Progress continues on all fronts from production operations to research and development, allowing us to advance our pipeline while expanding our business model. With our newly formed network of highly renowned experts from University of Alberta, McMaster University, the Montreal Heart Institute, and the Angiogenesis Foundation, we have implemented a comprehensive strategic research plan that we believe enables us to address immune/inflammation-based and lifestyle diseases at various stages and from all angles. Additionally, with upcoming results expected in the fourth quarter of this year for Ceapro’s very first clinical trial, I believe we are well positioned for the next steps in becoming a premier life sciences company. The Company has exciting things on the horizon and we are committed to building on momentum,” stated Gilles Gagnon, M.Sc., MBA, President and CEO.

Corporate and Operational Highlights

Pipeline Development:

• Announced successful completion of collaborative research and development program with University of Alberta. The program developed several new chemical complexes as potential delivery systems and demonstrated the possibility of drying peptides using Pressurized Gas eXpanded (PGX) Technology.
• Initiated bioavailability studies with University of Alberta for new chemical complexes yeast beta glucan-CoQ10 and alginate-CoQ10.
• Resumed research activities with McMaster University to develop an inhalable therapeutic for COVID-19 using yeast beta glucan.
• Completed patient enrollment in clinical study evaluating beta glucan as a cholesterol-lowering agent. Last patient last visit is expected by end of September 2021, followed by locking of data base, unblinding of the study and topline results expected in Q4 2021.

Technology:

• Pursued technical upgrades of PGX demo plant in Edmonton including initiation of commercial scale up of impregnation unit to produce chemical complexes.
• Initiated engineering design for PGX commercial scale unit. Final decision on the type and location of future commercial scale PGX unit to be announced during Q4 2021.

Production Operations:

• Successfully passed thorough audits conducted by two major customers for the Edmonton facility, which is now housing all production operations for the Company.
  

Corporate:

• Pursued out-licensing discussions for PGX-processed new chemical complexes.
  

Subsequent to Quarter:

• Announced research agreement with Montreal Heart Institute for a Phase 1 clinical trial assessing safety and tolerability of pharmaceutical grade avenanthramides.
• Announced research agreement with Boston-based Angiogenesis Foundation to assess in vivo bioefficacy of oat beta glucan and avenanthramides in angiogenesis, blood vessel repairs, wound healing and tissue regeneration in various inflammation-based diseases and conditions like COVID-19 presenting damages of the lung blood vessels.

Financial Highlights for the Second Quarter and the Six-Month Period Ended June 30, 2021

• Total sales of $4,409,000 for the second quarter of 2021 and $9,110,000 for the first six months of 2021 compared to $4,666,000 and $8,939,000 for the comparative periods in 2020.
  
  Sales being made in USA dollars and then reported in CDN dollars, it is noteworthy to look at the impact of the exchange rate (USD/CDN) from year to year. In fact, the Company has recorded respective sales in USD of $3.6M and USD $7.3M for the second quarter and the first six months of 2021 as compared to USD $3.4M and USD $6.5M for the comparative periods of 2020, representing a year-to-date effective increase of 12% in 2021.

• Net profit of $676,000 for the second quarter of 2021 and $1,191,000 for the first six months of 2021 compared to a net profit of $1,077,000 and $2,203,000 for the comparative periods in 2020.
  
  
• Cash flows generated from operations of $2,433,000 for the first six months of 2021 vs $2,727,000 in 2020.
  
  
• Positive working capital balance of $9,303,000 as of June 30, 2021.
  

“The ability of our business to successfully navigate through the challenging second quarter business environment is a testament to the commitment and hard work of our dedicated employees, and a measurable indication of the operational improvements generated by our strategic investments of the past few years,” continued Mr. Gagnon. “Looking ahead, while considering the ongoing potential economic impact related to the new surge of COVID-19, we believe Ceapro is well-positioned to once again deliver solid growth in 2021. With a strong and very clean balance sheet, a group of dedicated people, and a solid base business coupled with the innovative technologies and products that we have developed to enable us to expand, Ceapro is poised to emerge as a successful life science company.”

CEAPRO INC.
Consolidated Balance Sheets
Unaudited
	June 30,	December 31,
	2021	2020
	$	$
ASSETS
Current Assets
Cash and cash equivalents	7,269,428	5,369,029
Trade receivables	1,801,568	2,019,723
Other receivables	45,913	102,224
Inventories (note 3)	1,168,163	1,210,079
Prepaid expenses and deposits	236,932	348,845
	10,522,004	9,049,900
Non-Current Assets
Investment tax credits receivable	607,700	607,700
Deposits	82,124	82,124
Licences (note 4)	17,032	18,514
Property and equipment (note 5)	18,029,316	18,591,189
Deferred tax assets	874,304	874,304
	19,610,476	20,173,831
TOTAL ASSETS	30,132,480	29,223,731
LIABILITIES AND EQUITY
Current Liabilities
Accounts payable and accrued liabilities	857,731	1,067,622
Current portion of lease liabilities (note 6)	283,204	250,658
Current portion of CAAP loan (note 8)	77,855	72,263
	1,218,790	1,390,543
Non-Current Liabilities
Long-term lease liabilities (note 6)	2,505,623	2,648,917
Deferred tax liabilities	874,304	874,304
	3,379,927	3,523,221
TOTAL LIABILITIES	4,598,717	4,913,764
Equity
Share capital (note 7 (b))	16,555,619	16,511,067
Contributed surplus (note 7 (e))	4,670,289	4,682,393
Retained earnings	4,307,855	3,116,507
	25,533,763	24,309,967
TOTAL LIABILITIES AND EQUITY	30,132,480	29,223,731

CEAPRO INC.
Consolidated Statements of Net Income and Comprehensive Income
Unaudited
	Quarters Ended June 30,				Six Months Ended June 30,
	2021		2020		2021		2020
	$		$		$		$
Revenue (note 14)	4,408,631		4,665,971		9,110,374		8,939,345
Cost of goods sold	1,770,153		2,079,270		4,213,953		3,980,493
Gross margin	2,638,478		2,586,701		4,896,421		4,958,852
Research and product development	830,511		399,797		1,647,358		902,339
General and administration	952,847		838,263		1,665,054		1,703,297
Sales and marketing	16,362		29,207		29,600		77,435
Finance costs (note 11)	38,344		44,583		132,254		146,192
Income from operations	800,414		1,274,851		1,422,155		2,129,589
Other (expenses) income (note 10)	(123,942	)	(197,812	)	(230,807	)	73,505
Income before tax	676,472		1,077,039		1,191,348		2,203,094
Income taxes	–		–		–		–
Total comprehensive income for the period	676,472		1,077,039		1,191,348		2,203,094
Net income per common share (note 17):
Basic	0.01		0.01		0.02		0.03
Diluted	0.01		0.01		0.02		0.03
Weighted average number of common shares outstanding (note 17):
Basic	77,673,832		77,608,341		77,662,495		77,573,327
Diluted	78,684,303		77,980,876		78,684,344		77,930,529

CEAPRO INC.
Consolidated Statements of Cash Flows
Unaudited
	2021		2020
Six Months Ended June 30,	$		$
OPERATING ACTIVITIES
Net income for the period	1,191,348		2,203,094
Adjustments for items not involving cash
Finance costs	71,662		79,674
Transaction costs	–		1,108
Depreciation and amortization	937,356		920,521
Accretion	5,592		10,410
Share-based payments	6,828		108,147
Net income for the period adjusted for non-cash items	2,212,786		3,322,954
CHANGES IN NON-CASH WORKING CAPITAL ITEMS
Trade receivables	218,155		600,990
Other receivables	56,311		(43,599	)
Inventories	41,916		(592,489	)
Prepaid expenses and deposits	51,179		(33,088	)
Accounts payable and accrued liabilities relating to operating activities	(75,337	)	(448,200	)
Total changes in non-cash working capital items	292,224		(516,386	)
Net income for the period adjusted for non-cash and working capital items	2,505,010		2,806,568
Interest paid	(71,662	)	(79,674	)
CASH GENERATED FROM OPERATIONS	2,433,348		2,726,894
INVESTING ACTIVITIES
Purchase of property and equipment	(277,062	)	(38,230	)
Purchase of leasehold improvements	(19,472	)	–
Deposits relating to investment in equipment	(16,733	)	(50,203	)
Accounts payable and accrued liabilities relating to investing activities	(134,554	)	–
CASH USED IN INVESTING ACTIVITIES	(447,821	)	(88,433	)
FINANCING ACTIVITIES
Stock options exercised	25,620		–
Repayment of long-term debt	–		(97,507	)
Repayment of lease liabilities	(110,748	)	(130,829	)
CASH USED IN FINANCING ACTIVITIES	(85,128	)	(228,336	)
Increase in cash and cash equivalents	1,900,399		2,410,125
Cash and cash equivalents at beginning of the period	5,369,029		1,857,195
Cash and cash equivalents at end of the period	7,269,428		4,267,320

The complete financial statements are available for review on SEDAR at https://sedar.com/Ceapro and on the Company’s website at www.ceapro.com.

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

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Source: Ceapro Inc.

Ceapro Inc. Reports 2021 Second Quarter and Six-Month Financial Results and Operational Highlights

 

– Company continues to increase R&D activities to advance clinical and preclinical programs –

– Second quarter sales of $4,409,000 compared to $4,666,000 for second quarter 2020 –

– Cash generated from operations of $2,128,000 in Q2 2021 compared to $2,195,000 in Q2 2020 –

– Maintained production operations during COVID-19 pandemic, providing customers with essential products while ensuring the health and safety of our employees –

EDMONTON, Alberta, Aug. 26, 2021 (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 financial results and operational highlights for the second quarter and six months ended June 30, 2021.

“Progress continues on all fronts from production operations to research and development, allowing us to advance our pipeline while expanding our business model. With our newly formed network of highly renowned experts from University of Alberta, McMaster University, the Montreal Heart Institute, and the Angiogenesis Foundation, we have implemented a comprehensive strategic research plan that we believe enables us to address immune/inflammation-based and lifestyle diseases at various stages and from all angles. Additionally, with upcoming results expected in the fourth quarter of this year for Ceapro’s very first clinical trial, I believe we are well positioned for the next steps in becoming a premier life sciences company. The Company has exciting things on the horizon and we are committed to building on momentum,” stated Gilles Gagnon, M.Sc., MBA, President and CEO.

Corporate and Operational Highlights

Pipeline Development:

• Announced successful completion of collaborative research and development program with University of Alberta. The program developed several new chemical complexes as potential delivery systems and demonstrated the possibility of drying peptides using Pressurized Gas eXpanded (PGX) Technology.
• Initiated bioavailability studies with University of Alberta for new chemical complexes yeast beta glucan-CoQ10 and alginate-CoQ10.
• Resumed research activities with McMaster University to develop an inhalable therapeutic for COVID-19 using yeast beta glucan.
• Completed patient enrollment in clinical study evaluating beta glucan as a cholesterol-lowering agent. Last patient last visit is expected by end of September 2021, followed by locking of data base, unblinding of the study and topline results expected in Q4 2021.

Technology:

• Pursued technical upgrades of PGX demo plant in Edmonton including initiation of commercial scale up of impregnation unit to produce chemical complexes.
• Initiated engineering design for PGX commercial scale unit. Final decision on the type and location of future commercial scale PGX unit to be announced during Q4 2021.

Production Operations:

• Successfully passed thorough audits conducted by two major customers for the Edmonton facility, which is now housing all production operations for the Company.
  

Corporate:

• Pursued out-licensing discussions for PGX-processed new chemical complexes.
  

Subsequent to Quarter:

• Announced research agreement with Montreal Heart Institute for a Phase 1 clinical trial assessing safety and tolerability of pharmaceutical grade avenanthramides.
• Announced research agreement with Boston-based Angiogenesis Foundation to assess in vivo bioefficacy of oat beta glucan and avenanthramides in angiogenesis, blood vessel repairs, wound healing and tissue regeneration in various inflammation-based diseases and conditions like COVID-19 presenting damages of the lung blood vessels.

Financial Highlights for the Second Quarter and the Six-Month Period Ended June 30, 2021

• Total sales of $4,409,000 for the second quarter of 2021 and $9,110,000 for the first six months of 2021 compared to $4,666,000 and $8,939,000 for the comparative periods in 2020.
  
  Sales being made in USA dollars and then reported in CDN dollars, it is noteworthy to look at the impact of the exchange rate (USD/CDN) from year to year. In fact, the Company has recorded respective sales in USD of $3.6M and USD $7.3M for the second quarter and the first six months of 2021 as compared to USD $3.4M and USD $6.5M for the comparative periods of 2020, representing a year-to-date effective increase of 12% in 2021.

• Net profit of $676,000 for the second quarter of 2021 and $1,191,000 for the first six months of 2021 compared to a net profit of $1,077,000 and $2,203,000 for the comparative periods in 2020.
  
  
• Cash flows generated from operations of $2,433,000 for the first six months of 2021 vs $2,727,000 in 2020.
  
  
• Positive working capital balance of $9,303,000 as of June 30, 2021.
  

“The ability of our business to successfully navigate through the challenging second quarter business environment is a testament to the commitment and hard work of our dedicated employees, and a measurable indication of the operational improvements generated by our strategic investments of the past few years,” continued Mr. Gagnon. “Looking ahead, while considering the ongoing potential economic impact related to the new surge of COVID-19, we believe Ceapro is well-positioned to once again deliver solid growth in 2021. With a strong and very clean balance sheet, a group of dedicated people, and a solid base business coupled with the innovative technologies and products that we have developed to enable us to expand, Ceapro is poised to emerge as a successful life science company.”

CEAPRO INC.
Consolidated Balance Sheets
Unaudited
	June 30,	December 31,
	2021	2020
	$	$
ASSETS
Current Assets
Cash and cash equivalents	7,269,428	5,369,029
Trade receivables	1,801,568	2,019,723
Other receivables	45,913	102,224
Inventories (note 3)	1,168,163	1,210,079
Prepaid expenses and deposits	236,932	348,845
	10,522,004	9,049,900
Non-Current Assets
Investment tax credits receivable	607,700	607,700
Deposits	82,124	82,124
Licences (note 4)	17,032	18,514
Property and equipment (note 5)	18,029,316	18,591,189
Deferred tax assets	874,304	874,304
	19,610,476	20,173,831
TOTAL ASSETS	30,132,480	29,223,731
LIABILITIES AND EQUITY
Current Liabilities
Accounts payable and accrued liabilities	857,731	1,067,622
Current portion of lease liabilities (note 6)	283,204	250,658
Current portion of CAAP loan (note 8)	77,855	72,263
	1,218,790	1,390,543
Non-Current Liabilities
Long-term lease liabilities (note 6)	2,505,623	2,648,917
Deferred tax liabilities	874,304	874,304
	3,379,927	3,523,221
TOTAL LIABILITIES	4,598,717	4,913,764
Equity
Share capital (note 7 (b))	16,555,619	16,511,067
Contributed surplus (note 7 (e))	4,670,289	4,682,393
Retained earnings	4,307,855	3,116,507
	25,533,763	24,309,967
TOTAL LIABILITIES AND EQUITY	30,132,480	29,223,731

CEAPRO INC.
Consolidated Statements of Net Income and Comprehensive Income
Unaudited
	Quarters Ended June 30,				Six Months Ended June 30,
	2021		2020		2021		2020
	$		$		$		$
Revenue (note 14)	4,408,631		4,665,971		9,110,374		8,939,345
Cost of goods sold	1,770,153		2,079,270		4,213,953		3,980,493
Gross margin	2,638,478		2,586,701		4,896,421		4,958,852
Research and product development	830,511		399,797		1,647,358		902,339
General and administration	952,847		838,263		1,665,054		1,703,297
Sales and marketing	16,362		29,207		29,600		77,435
Finance costs (note 11)	38,344		44,583		132,254		146,192
Income from operations	800,414		1,274,851		1,422,155		2,129,589
Other (expenses) income (note 10)	(123,942	)	(197,812	)	(230,807	)	73,505
Income before tax	676,472		1,077,039		1,191,348		2,203,094
Income taxes	–		–		–		–
Total comprehensive income for the period	676,472		1,077,039		1,191,348		2,203,094
Net income per common share (note 17):
Basic	0.01		0.01		0.02		0.03
Diluted	0.01		0.01		0.02		0.03
Weighted average number of common shares outstanding (note 17):
Basic	77,673,832		77,608,341		77,662,495		77,573,327
Diluted	78,684,303		77,980,876		78,684,344		77,930,529

CEAPRO INC.
Consolidated Statements of Cash Flows
Unaudited
	2021		2020
Six Months Ended June 30,	$		$
OPERATING ACTIVITIES
Net income for the period	1,191,348		2,203,094
Adjustments for items not involving cash
Finance costs	71,662		79,674
Transaction costs	–		1,108
Depreciation and amortization	937,356		920,521
Accretion	5,592		10,410
Share-based payments	6,828		108,147
Net income for the period adjusted for non-cash items	2,212,786		3,322,954
CHANGES IN NON-CASH WORKING CAPITAL ITEMS
Trade receivables	218,155		600,990
Other receivables	56,311		(43,599	)
Inventories	41,916		(592,489	)
Prepaid expenses and deposits	51,179		(33,088	)
Accounts payable and accrued liabilities relating to operating activities	(75,337	)	(448,200	)
Total changes in non-cash working capital items	292,224		(516,386	)
Net income for the period adjusted for non-cash and working capital items	2,505,010		2,806,568
Interest paid	(71,662	)	(79,674	)
CASH GENERATED FROM OPERATIONS	2,433,348		2,726,894
INVESTING ACTIVITIES
Purchase of property and equipment	(277,062	)	(38,230	)
Purchase of leasehold improvements	(19,472	)	–
Deposits relating to investment in equipment	(16,733	)	(50,203	)
Accounts payable and accrued liabilities relating to investing activities	(134,554	)	–
CASH USED IN INVESTING ACTIVITIES	(447,821	)	(88,433	)
FINANCING ACTIVITIES
Stock options exercised	25,620		–
Repayment of long-term debt	–		(97,507	)
Repayment of lease liabilities	(110,748	)	(130,829	)
CASH USED IN FINANCING ACTIVITIES	(85,128	)	(228,336	)
Increase in cash and cash equivalents	1,900,399		2,410,125
Cash and cash equivalents at beginning of the period	5,369,029		1,857,195
Cash and cash equivalents at end of the period	7,269,428		4,267,320

The complete financial statements are available for review on SEDAR at https://sedar.com/Ceapro and on the Company’s website at www.ceapro.com.

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

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Source: Ceapro Inc.

Wednesday, August 25, 2021

Helius Medical Technologies (HSDT)(HSM:CA)
$32 Million Market Cap With A Multi-Billion TAM – What’s The Disconnect?

Helius Medical Technologies is a neurotech company focused on neurological wellness. The Company’s purpose is to develop, license and acquire unique and non-invasive platform technologies that amplify the brain’s ability to heal itself. The Company’s first commercial product is the Portable Neuromodulation Stimulator (PoNSTM). For more information, visit www.heliusmedical.com.

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

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

Can’t See the Forest For the Trees? We believe investors are missing the big picture at Helius Medical Technologies. Last week the Company received its second Breakthrough Designation from the U.S. Food and Drug Administration (FDA) for its PoNS device, this time for treatment of stroke patients with dynamic gait and balance deficits. Investors are missing the importance of the announcement, in our view.


Second Breakthrough Designation.  To put last week’s announcement in perspective, there are over 400 companies with a Breakthrough Device Designation. Only 5.65% have FDA clearance, which Helius is one of them. For a company to have a second BDD puts Helius in rare air …

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. 

Wednesday, August 25, 2021

Helius Medical Technologies (HSDT)(HSM:CA)
$32 Million Market Cap With A Multi-Billion TAM – What’s The Disconnect?

Helius Medical Technologies is a neurotech company focused on neurological wellness. The Company’s purpose is to develop, license and acquire unique and non-invasive platform technologies that amplify the brain’s ability to heal itself. The Company’s first commercial product is the Portable Neuromodulation Stimulator (PoNSTM). For more information, visit www.heliusmedical.com.

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

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

Can’t See the Forest For the Trees? We believe investors are missing the big picture at Helius Medical Technologies. Last week the Company received its second Breakthrough Designation from the U.S. Food and Drug Administration (FDA) for its PoNS device, this time for treatment of stroke patients with dynamic gait and balance deficits. Investors are missing the importance of the announcement, in our view.


Second Breakthrough Designation.  To put last week’s announcement in perspective, there are over 400 companies with a Breakthrough Device Designation. Only 5.65% have FDA clearance, which Helius is one of them. For a company to have a second BDD puts Helius in rare air …

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. 

electroCore Announces New Reseller Agreement with Red One Medical Devices, LLC

 

ROCKAWAY, NJ, 
Aug. 24, 2021 (GLOBE NEWSWIRE) — 
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced a reseller agreement with 
Red One Medical Devices, LLC. (Red One). The partnership will further expand availability of electroCore’s gammaCore platform in the federal marketplace.

Red One is a Service-Disabled Veteran-Owned Small Business (SDVOSB) offering medical and pharmaceutical goods and services to the 
U.S. Department of Veterans Affairs (VA) and 
Department of Defense (
DoD) hospitals, ensuring compliance with contracting regulations, and providing logistical solutions connected directly into government contracting portals such as ECAT, 
GSA, DAPA, BPA, and DIBBS.

“As a 
VA and 
DoD private sector partner for medical innovation, we are excited to partner with electroCore,” said  Charles Pollak, President of Red One. “Their gammaCore therapy may help thousands of military personnel, family and veterans suffering from primary headache. Painful and disabling headaches torment more than 20% of former service members, especially those from the post-9/11 combat veteran cohort. We look forward to partnering with electroCore to make the therapy more easily accessible in the federal marketplace.”

“Partnering with Red One will help accelerate adoption of electroCore’s therapy within the government channel,” commented  Dan Goldberger, Chief Executive Officer of electroCore. “Our partnership gives electroCore access to a variety of contracting portals enabling easier procurement of gammaCore therapy across veteran and active military channels. We have just begun to scratch the surface of the help we can provide to our veterans, troops, and family members in 
VA and 
DoD, and we are honored to partner with an SDVOSB to make gammaCore more widely available to those veterans and active-duty military who can benefit from our therapy.”

About Red One Medical Devices, LLC
Red One is transforming healthcare for America’s military service members and veterans. Red One identifies and delivers advanced medical and pharmaceutical technologies to the federal government. These products meet the unique needs of military surgeons and patients. They are clinically proven to improve treatment outcomes in both the 
DoD and 
VA. Red One accelerates the procurement process, oftentimes making products available to the government before they’re offered in the private sector. Their team is on a mission to provide veterans with top quality care.

With over 90 combined years of experience in medical sales and government contracting, Red One provides medical and pharmaceutical companies access to the federal marketplace. Red One is a government certified Service-Disabled Veteran Owned Small Business (SDVOSB) and Disability-Owned Business Enterprise (DOBE). Red One connects leading medical and pharmaceutical manufacturers to 
US Department of Veterans Affairs (VA) and 
Department of Defense (
DoD) hospitals.

About electroCore, Inc.
electroCore, Inc. is a commercial stage bioelectronic medicine company dedicated to improving patient outcomes through its non-invasive vagus nerve stimulation therapy platform, initially focused on the treatment of multiple conditions in neurology. The company’s current indications are the preventive treatment of cluster headache and migraine and the acute treatment of migraine and episodic cluster headache.
For more information, visit www.electrocore.com.

About gammaCoreTM
gammaCoreTM (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck as an adjunctive therapy to treat migraine and cluster headache through the utilization of a mild electrical stimulation to the vagus nerve that passes through the skin. Designed as a portable, easy-to-use technology, gammaCore can be self-administered by patients, as needed, without the potential side effects associated with commonly prescribed drugs. When placed on a patient’s neck over the vagus nerve, gammaCore stimulates the nerve’s afferent fibers, which may lead to a reduction of pain in patients.

gammaCore (nVNS) is FDA cleared in 
the United States for adjunctive use for the preventive treatment of cluster headache in adult patients, the acute treatment of pain associated with episodic cluster headache in adult patients, and the acute and preventive treatment of migraine in adolescent (ages 12 and older) and adult patients. gammaCore is CE-marked in the 
European Union for the acute and/or prophylactic treatment of primary headache (Migraine, Cluster Headache, Trigeminal Autonomic Cephalalgias and Hemicrania Continua) and Medication Overuse Headache in adults.

gammaCore is contraindicated for patients if they:

• Have an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
• Have a metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck
• Are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)
  
  

Safety and efficacy of gammaCore have not been evaluated in the following patients:

• Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
• Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
• Pediatric patients (less than 12 years)
• Pregnant women
• Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia
  
  

Please refer to the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product.

Forward-Looking Statements
This press release and other written and oral statements made by representatives of electroCore may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about electroCore’s anticipated benefits of accessing Red One’s federal marketplace network; its business prospects and clinical and product development plans; its pipeline or potential markets for its technologies; the timing, outcome and impact of regulatory, clinical and commercial developments; the availability and impact of payer coverage, the potential of nVNS generally and other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “believes,” “intends,” other words of similar meaning, derivations of such words and the use of future dates. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to raise the additional funding needed to continue to pursue electroCore’s business and product development plans, the inherent uncertainties associated with developing new products or technologies, the ability to commercialize gammaCore™, the potential impact and effects of COVID-19 on the business of electroCore, electroCore’s results of operations and financial performance, and any measures electroCore has and may take in response to COVID-19 and any expectations electroCore may have with respect thereto, competition in the industry in which electroCore operates and overall market conditions. Any forward-looking statements are made as of the date of this press release, and electroCore assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents electroCore files with the 
SEC available at www.sec.gov.

Investors:
Rich CockrellCG Capital
404-736-3838
ecor@cg.capital

or

Media Contact:
Jackie Dorsky
electroCore
908-313-6331
Jackie.dorsky@electrocore.com

electroCore Announces New Reseller Agreement with Red One Medical Devices, LLC

 

ROCKAWAY, NJ, 
Aug. 24, 2021 (GLOBE NEWSWIRE) — 
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced a reseller agreement with 
Red One Medical Devices, LLC. (Red One). The partnership will further expand availability of electroCore’s gammaCore platform in the federal marketplace.

Red One is a Service-Disabled Veteran-Owned Small Business (SDVOSB) offering medical and pharmaceutical goods and services to the 
U.S. Department of Veterans Affairs (VA) and 
Department of Defense (
DoD) hospitals, ensuring compliance with contracting regulations, and providing logistical solutions connected directly into government contracting portals such as ECAT, 
GSA, DAPA, BPA, and DIBBS.

“As a 
VA and 
DoD private sector partner for medical innovation, we are excited to partner with electroCore,” said  Charles Pollak, President of Red One. “Their gammaCore therapy may help thousands of military personnel, family and veterans suffering from primary headache. Painful and disabling headaches torment more than 20% of former service members, especially those from the post-9/11 combat veteran cohort. We look forward to partnering with electroCore to make the therapy more easily accessible in the federal marketplace.”

“Partnering with Red One will help accelerate adoption of electroCore’s therapy within the government channel,” commented  Dan Goldberger, Chief Executive Officer of electroCore. “Our partnership gives electroCore access to a variety of contracting portals enabling easier procurement of gammaCore therapy across veteran and active military channels. We have just begun to scratch the surface of the help we can provide to our veterans, troops, and family members in 
VA and 
DoD, and we are honored to partner with an SDVOSB to make gammaCore more widely available to those veterans and active-duty military who can benefit from our therapy.”

About Red One Medical Devices, LLC
Red One is transforming healthcare for America’s military service members and veterans. Red One identifies and delivers advanced medical and pharmaceutical technologies to the federal government. These products meet the unique needs of military surgeons and patients. They are clinically proven to improve treatment outcomes in both the 
DoD and 
VA. Red One accelerates the procurement process, oftentimes making products available to the government before they’re offered in the private sector. Their team is on a mission to provide veterans with top quality care.

With over 90 combined years of experience in medical sales and government contracting, Red One provides medical and pharmaceutical companies access to the federal marketplace. Red One is a government certified Service-Disabled Veteran Owned Small Business (SDVOSB) and Disability-Owned Business Enterprise (DOBE). Red One connects leading medical and pharmaceutical manufacturers to 
US Department of Veterans Affairs (VA) and 
Department of Defense (
DoD) hospitals.

About electroCore, Inc.
electroCore, Inc. is a commercial stage bioelectronic medicine company dedicated to improving patient outcomes through its non-invasive vagus nerve stimulation therapy platform, initially focused on the treatment of multiple conditions in neurology. The company’s current indications are the preventive treatment of cluster headache and migraine and the acute treatment of migraine and episodic cluster headache.
For more information, visit www.electrocore.com.

About gammaCoreTM
gammaCoreTM (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck as an adjunctive therapy to treat migraine and cluster headache through the utilization of a mild electrical stimulation to the vagus nerve that passes through the skin. Designed as a portable, easy-to-use technology, gammaCore can be self-administered by patients, as needed, without the potential side effects associated with commonly prescribed drugs. When placed on a patient’s neck over the vagus nerve, gammaCore stimulates the nerve’s afferent fibers, which may lead to a reduction of pain in patients.

gammaCore (nVNS) is FDA cleared in 
the United States for adjunctive use for the preventive treatment of cluster headache in adult patients, the acute treatment of pain associated with episodic cluster headache in adult patients, and the acute and preventive treatment of migraine in adolescent (ages 12 and older) and adult patients. gammaCore is CE-marked in the 
European Union for the acute and/or prophylactic treatment of primary headache (Migraine, Cluster Headache, Trigeminal Autonomic Cephalalgias and Hemicrania Continua) and Medication Overuse Headache in adults.

gammaCore is contraindicated for patients if they:

• Have an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
• Have a metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck
• Are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone)
  
  

Safety and efficacy of gammaCore have not been evaluated in the following patients:

• Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
• Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
• Pediatric patients (less than 12 years)
• Pregnant women
• Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia
  
  

Please refer to the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product.

Forward-Looking Statements
This press release and other written and oral statements made by representatives of electroCore may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about electroCore’s anticipated benefits of accessing Red One’s federal marketplace network; its business prospects and clinical and product development plans; its pipeline or potential markets for its technologies; the timing, outcome and impact of regulatory, clinical and commercial developments; the availability and impact of payer coverage, the potential of nVNS generally and other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “believes,” “intends,” other words of similar meaning, derivations of such words and the use of future dates. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to raise the additional funding needed to continue to pursue electroCore’s business and product development plans, the inherent uncertainties associated with developing new products or technologies, the ability to commercialize gammaCore™, the potential impact and effects of COVID-19 on the business of electroCore, electroCore’s results of operations and financial performance, and any measures electroCore has and may take in response to COVID-19 and any expectations electroCore may have with respect thereto, competition in the industry in which electroCore operates and overall market conditions. Any forward-looking statements are made as of the date of this press release, and electroCore assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents electroCore files with the 
SEC available at www.sec.gov.

Investors:
Rich CockrellCG Capital
404-736-3838
ecor@cg.capital

or

Media Contact:
Jackie Dorsky
electroCore
908-313-6331
Jackie.dorsky@electrocore.com

Monday, August 23, 2021

Cocrystal Pharma Inc. (COCP)
2Q21 Reported With Clinical Milestones For 2021-22

Cocrystal Pharma Inc is a clinical stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication machinery of influenza viruses, hepatitis C viruses, and noroviruses. The company employs structure-based technologies and Nobel Prize-winning expertise to create first-and best-in-class antiviral drugs. It is developing CC-31244, an investigational, oral, broad-spectrum replication inhibitor called a non-nucleoside inhibitor (NNI). CC-31244 is currently being evaluated in a Phase 2a study for the treatment of hepatitis C as part of a cocktail for ultra-short therapy of 4 to 6 weeks.

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

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

Cocrystal Reports 2Q21 With Clinical Trial Milestones. Cocrystal Pharmaceuticals reported 2Q21 results of a loss of $3.8 million or $(0.04) per share, compared with our expected loss of $3.1 million or (0.04) per share. Differences from our estimates were largely due to higher Research expenses for product development and lower General Expenses. The company ended the quarter with $67.1 million in cash. Based on our estimates for research programs and net losses, we expect this cash to last into 2024.


COVID-19 Program Has Two Preclinical Studies.   Cocrystal has two programs developing protease inhibitors against the virus that causes COVID-19, SARS-CoV-2.  The company plans to hold a pre-IND meeting with the FDA for CDI-45205 later this year, with an IND enabling study in 1H22 using intranasal/pulmonary delivery. A pre-IND for an oral inhibitor in is expected in 1H22, followed by an IND-enabling …

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.