The Investor Forum at the World Stem Cell Summit
June 17, 2021

View the Investor Forum Presentations Here

View the Official Investor Forum Book Here

The following companies are scheduled to take part in the Investor Forum at the World Stem Cell Summit – June 17, 2021. The event will be broadcast on the World Stem Cell Summit Website, as well as on Channelchek.com. Each presentation will feature a 20-minute formal corporate overview, followed by a 20 minute Q & A session moderated by a Noble Capital Markets equity research representative.

Register for Channechek to gain access to the Investor Forum

Register for the full World Stem Cell Summit

Click the logos for more information on the presenting companies

Avalon GloboCare (AVCO)	Caladrius Biosciences (CLBS)
Celularity	ImmCelz / Creative Medical Technology Holdings (CELZ)
ExoProTher	GID BIO
HealthLynked (HLYK)	Longeveron (LGVN)
Mesoblast (MESO)

Ocugen to pursue a BLA path in the US for its COVID-19 vaccine candidate

 

• Company intends to work with the FDA towards filing a Biologics License Application (BLA) in the US
  
• Company to engage with Health Canada to seek authorization under Interim Order for use in Canada
  

MALVERN, Pa., June 10, 2021 (GLOBE NEWSWIRE) — Ocugen, Inc. (NASDAQ: OCGN) (Company), 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, today announced that upon recommendation from the U.S. Food and Drug Administration (FDA), it will pursue submission of a biologics license application (BLA) for its COVID-19 vaccine candidate, COVAXIN™. The Company will no longer pursue an Emergency Use Authorization (EUA) for COVAXIN™.

The FDA provided feedback to Ocugen regarding the Master File the Company had previously submitted and recommended that Ocugen pursue a BLA submission instead of an EUA application for its vaccine candidate and requested additional information and data. Ocugen is in discussions with the FDA to understand the additional information required to support a BLA submission. The Company anticipates that data from an additional clinical trial will be required to support the submission.

“Although we were close to finalizing our EUA application for submission, we received a recommendation from the FDA to pursue a BLA path. While this will extend our timelines, we are committed to bringing COVAXIN™ to the US. This differentiated vaccine is a critical tool to include in our national arsenal given its potential to address the SARS-CoV-2 variants, including the delta variant, and given the unknowns about what will be needed to protect US population in the long term,” said Dr. Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and Co-founder of Ocugen.

Ocugen recently announced that it secured exclusive rights to commercialize COVAXIN™ in Canada and has initiated discussions with Health Canada for regulatory approval. The Company will pursue expedited authorization for COVAXIN™ under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 in Canada.

“In clinical trials to date, the emerging safety profile of COVAXIN™ is supportive of it being generally well tolerated with a good safety profile, with Ministry of Health and Family Welfare of Republic of India reporting no potential thromboembolic events following the administration of over 6.7 million doses of COVAXIN™ in that country,” said Dr. Bruce Forrest, Acting Chief Medical Officer and member of the vaccine scientific advisory board of Ocugen.

About COVAXIN™

COVAXIN™, India’s COVID-19 vaccine by Bharat Biotech, is developed in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). COVAXIN™ is a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform. This platform has an excellent safety track record of more than 300 million doses of various vaccines supplied. Based on a traditional vaccine platform that has a long-established safety profile, COVAXIN™ continues to show strong results in all the studies conducted to date including a vaccine efficacy rate of 78% overall efficacy and 100% in severe COVID-19 disease, including hospitalizations, in second interim results of Bharat Biotech’s Phase 3 clinical trial.

In addition to generating strong immune response against multiple antigens, COVAXIN has been shown to generate memory T cell responses, for its multiple epitopes, indicating longevity and a rapid antibody response to future infections. With published data demonstrating a safety profile superior to published safety data from separate studies for several other vaccines, COVAXIN™ is packaged in multi-dose vials that can be stored at 2-8^?C.

COVAXIN™ studies show potential effectiveness against three key variants of SARS-CoV-2. Scientists at the Indian Council of Medical Research (ICMR)-National Institute of Virology, using an in-vitro plaque reduction neutralization assay, have found that COVAXIN-vaccinated sera effectively neutralized the Brazil variant of SARS-CoV-2, B.1.128.2, the alpha variant, B.1.1.7, which was first identified in the United Kingdom, as well as the delta variant, B.1.617, which was first identified in India. These studies suggest that COVAXIN vaccination may be effective against multiple SARS-CoV-2 variants.

Based on the more than 30 million doses supplied in India and other countries, COVAXIN™ has an excellent safety record. COVAXIN™ is currently being administered under emergency use authorizations in 13 countries, and applications for emergency use authorization are pending in more than 60 additional countries.

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 http://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 forward-looking statements include information about qualitative assessments of available data, potential benefits, expectations for clinical trials, and anticipated timing of clinical trial readouts and regulatory submissions. This information involves risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preliminary and interim data (including the interim data from Bharat Biotech’s Phase 3 trial in India referred to in this press release), including the possibility of unfavorable new clinical trial data and further analyses of existing clinical trial data; the risk that the results of in-vitro studies will not be duplicated in human clinical trials; the risk that clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when data from Bharat Biotech’s clinical trials will be published in scientific journal publications and, if so, when and with what modifications; whether we will be able to provide the U.S. Food and Drug Administration (FDA) with sufficient additional information regarding the design of and results from preclinical and clinical studies of COVAXIN, which have been conducted by Bharat Biotech in India in order for those trials to support a biologics license application (BLA), the size, scope, timing and outcome of any additional trials or studies that we may be required to conduct to support a BLA; any additional chemistry, manufacturing and controls information that we may be required to submit the timing of our BLA filing; whether and when an application for authorization under interim order for emergency use will be filed in Canada; whether and when any such applications may be approved by Health Canada; whether developments with respect to COVID-19 pandemic will affect the regulatory pathway available for vaccines in the United States, Canada or other jurisdictions; market demand for COVAXIN in the United States or Canada; decisions by the FDA or Health Canada impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of COVAXIN in the United States or Canada, including development of products or therapies by other companies. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (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:
Ocugen, Inc.
Sanjay Subramanian
CFO and Head of Corp. Dev.
IR@Ocugen.com

Media Contact:
LaVoieHealthScience
Sharon Correia
scorreia@lavoiehealthscience.com617-865-0038

Ocugen Inc. Announces Michael Shine as Senior Vice President, Commercial

 

MALVERN, Pa., June 10, 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 save lives from COVID-19, today announced that Michael Shine will be joining Ocugen as Senior Vice President, Commercial.

Michael Shine is a pharmaceutical and biotechnology executive with nearly 35 years of industry experience. Over the course of his career, Mr. Shine has held leadership positions within large pharmaceutical companies, including Novapharm Therapeutics, Colgate Oral Pharmaceutical, and Pfizer Vaccines (formerly Wyeth). He also served as Chief Marketing Officer with Thomas Reuters and spent more than eight years in the start-up pharmaceutical space.

“We are thrilled to welcome Mike to the Ocugen team as we take steps towards readiness for potential commercialization of COVAXIN in the US and Canada. As an established marketing and sales biopharma leader, Mike’s experience and commercial expertise will be instrumental to our market launches for Ocugen’s vaccine and ophthalmologic product pipelines, in each case if approved,” said Dr. Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and Co-founder of Ocugen.

Mr. Shine led the successful commercial launch of the global $6 billion Prevnar vaccine franchise while with Pfizer Vaccines (formerly Wyeth). Mr. Shine was responsible for the development of innovative strategies for Prevenar’s inclusion in national immunization programs in key markets, driving sales in excess of $2 billion. Mr. Shine holds a Master of Business Administration from Villanova University, and a Bachelor of Science in business administration from the University of Scranton.  

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 US market. For more information, please visit http://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 forward-looking statements include information about qualitative assessments of available data, potential benefits, expectations for clinical trials, and anticipated timing of clinical trial readouts and regulatory submissions. This information involves risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preliminary and interim data (including the interim data from Bharat Biotech’s Phase 3 trial in India), including the possibility of unfavorable new clinical trial data and further analyses of existing clinical trial data; the risk that the results of in-vitro studies will not be duplicated in human clinical trials; the risk that clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when data from Bharat Biotech’s clinical trials will be published in scientific journal publications and, if so, when and with what modifications; whether we will be able to provide the U.S. Food and Drug Administration (FDA) with sufficient additional information regarding the design of and results from preclinical and clinical studies of COVAXIN, which have been conducted by Bharat Biotech in India in order for those trials to support a biologics license application (BLA), the size, scope, timing and outcome of any additional trials or studies that we may be required to conduct to support a BLA; any additional chemistry, manufacturing and controls information that we may be required to submit; the timing of our BLA filing; whether and when an application for authorization under interim order for emergency use will be filed in Canada; whether and when any such applications may be approved by Health Canada; whether developments with respect to COVID-19 pandemic will affect the regulatory pathway available for vaccines in the United States, Canada or other jurisdictions; market demand for COVAXIN in the United States or Canada; decisions by the FDA or Health Canada impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of COVAXIN in the United States or Canada, including development of products or therapies by other companies. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (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:
Ocugen, Inc.
Sanjay Subramanian
Chief Financial Officer and Head of Corporate Development
IR@Ocugen.com

Media Contact:
LaVoieHealthScience
Sharon Correia
scorreia@lavoiehealthscience.com

Thursday, June 10, 2021

Onconova Therapeutics (ONTX)
Looking Forward to Upcoming Clinical Milestones

Onconova Therapeutics Inc is a clinical-stage biopharmaceutical company operating in the US. It focuses on discovering and developing novel small molecule product candidates primarily to treat cancer. The company has created a library of targeted agents designed to work against cellular pathways important to cancer cells. Its product candidates are Single-agent IV rigosertib, Oral rigosertib + azacitidine, IV Briciclib, Recilisib, and ON 123300. The key product candidate Rigosertib is a small molecule which blocks cellular signaling by targeting RAS effector pathways.

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

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

Developing drugs to stop the signals that lead to tumor cell growth.  Onconova has two drugs in clinical testing, ON 123300 and rigosertib, which target pathways between the cell surface and DNA transcription. These drugs are in clinical trials for both cancers affecting large populations and an orphan tumor. We are maintaining our Outperform rating with a split-adjusted price target of $11 per share.


Clinical trials are progressing.  ON 123300 is a multi-kinase inhibitor in development to stop signals in the cell nucleus that lead to cancer cell proliferation. A Phase 1 dose-escalation trial has opened in the US, and a trial in China has dosed its third cohort. Selection of dosing for a Phase 2 clinical trial is expected in 2H21 …

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 Completes Sale of $1.4 Million of NJ NOL Tax Benefits

 

ROCKAWAY, NJ, 
June 09, 2021 (GLOBE NEWSWIRE) — 
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced that it has completed the sale of 
$1.4 million of its available tax benefits through the New Jersey Economic Development Authority’s Technology Business Tax Certificate Transfer program for fiscal years 2019 and 2020. As a result, the Company has received approximately 
$1.4 million in non-dilutive cash from the sale of these net operating loss (NOL) tax benefits.

“This transaction strengthens our balance sheet and further improves our cash position,” commented  Brian Posner, Chief Financial Officer of electroCore. “The funding will extend our efforts in commercializing gammaCore and fortify our ability to expand our non-invasive vagus nerve stimulation (nVNS) therapy into new markets.”

The New Jersey Technology Business Tax Certificate Transfer program enables qualified, NJ-based technology or biotechnology companies with NOLs and fewer than 225 U.S. employees to sell a percentage of their NOL tax credits to unrelated profitable corporations. NOLs may be sold for at least 80 percent of their value, up to a maximum lifetime benefit of 
$15 million per business. This allows qualifying technology and biotechnology companies with NOLs to turn tax losses and credits into cash proceeds to fund their growth and operations, including research and development or other allowable expenditures.

About electroCore, Inc.

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

For more information, visit www.electrocore.com.

About gammaCore^TM

gammaCore^TM (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 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 pacemaker, hearing aid implant, or 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 of age)
  • Pregnant women
  • Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia

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

Forward-looking statement
This press release 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 regarding electroCore’s business prospects, its sales and marketing and product development plans, future cash flow projections, anticipated costs, its product portfolio or potential markets for its technologies, the availability and impact of payor coverage, the potential of nVNS generally and gammaCore in particular to treat COVID-19, and other statements that are not historical in nature, particularly those using terminology such as “anticipates,” “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 obtain additional financing necessary to continue electroCore’s business, sales and marketing and product development plans, the uncertainties inherent in the development of new products or technologies, the ability to successfully commercialize gammaCore™, competition in the industry in which electroCore operates and general market conditions. All forward-looking statements are made as of the date of this press release, and electroCore undertakes no obligation to update 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 refer to all information set forth in this document and should also refer to the disclosure of risk factors 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:
Summer Diaz
electroCore
816-401-6333
summer.diaz@electrocore.com

Lineage Cell Therapeutics Set to Join Russell 3000® Index and Russell Microcap® Index

 

CARLSBAD, Calif.–(BUSINESS WIRE)–Jun. 9, 2021– 

Lineage Cell Therapeutics, Inc.
 (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, announced today that it is set to join the broad-market Russell 3000^® Index as well as the Russell Microcap^® Index at the conclusion of the 2021 Russell indexes annual reconstitution, effective after the U.S. market opens on 
June 28, 2021, according to a preliminary list of additions posted on 
June 4, 2021, by FTSE Russell, a leading global index provider.

Annual Russell indexes reconstitution captures the 4,000 largest 
U.S. stocks as of 
May 7, 2021, ranking them by total market capitalization. Membership in the 
U.S. all-cap Russell 3000^® Index, which remains in place for one year, means automatic inclusion in the large-cap Russell 1000^® Index or small-cap Russell 2000^® Index as well as the appropriate growth and value style indexes. Membership in the Russell Microcap^® Index, which remains in place for one year, means automatic inclusion in the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings and style attributes.

“Lineage’s inclusion on the preliminary list of additions to the Russell 3000^® Index and the Russell Microcap^® Index reflects progress we have made to establish ourselves as a leader in cell therapy and regenerative medicine,” stated  Brian M. Culley, Lineage’s CEO. “During the past year, we have delivered significant clinical, manufacturing, and business milestones which have created considerable value for our shareholders, and we intend to be diligent in our efforts to benefit from the explosive growth we believe the field of cell therapy will experience in the months and years ahead. We believe our inclusion in the Russell indexes will help broaden awareness of Lineage’s corporate mission and objectives among a wider audience of investors and help drive an increase in the liquidity of our stock.”

Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately 
$10.6 trillion in assets are benchmarked against Russell’s US indexes. Russell indexes are part of FTSE Russell.

About FTSE Russell

FTSE Russell is a global index leader that provides innovative benchmarking, analytics and data solutions for investors worldwide. FTSE Russell calculates thousands of indexes that measure and benchmark markets and asset classes in more than 70 countries, covering 98% of the investable market globally. FTSE Russell index expertise and products are used extensively by institutional and retail investors globally. Approximately 
$17.9 trillion is currently benchmarked to FTSE Russell indexes. For over 30 years, leading asset owners, asset managers, ETF providers and investment banks have chosen FTSE Russell indexes to benchmark their investment performance and create ETFs, structured products and index-based derivatives. A core set of universal principles guides FTSE Russell index design and management: a transparent rules-based methodology is informed by independent committees of leading market participants. FTSE Russell is focused on applying the highest industry standards in index design and governance and embraces the IOSCO Principles. FTSE Russell is also focused on index innovation and customer partnerships as it seeks to enhance the breadth, depth and reach of its offering. FTSE Russell is wholly owned by London Stock Exchange Group. For more information, visit www.ftserussell.com.

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, a leading cause of blindness in the developed world; (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.

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,” “can,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” project,” “target,” “tend to,” or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to Lineage’s inclusion in the Russell indexes, anticipated growth in the field of cell therapy, and the potential benefits to Lineage and its shareholders as a result. 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 in Lineage’s filings with the 
Securities and Exchange Commission (SEC). 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. Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the 
SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the 
SEC and its other reports, which are available from the SEC’s website. 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.

The information in this announcement about the Russell indexes and FTSE Russell was obtained from FTSE Russell. Lineage has not independently verified such information and there can be no assurance as to its accuracy.

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.

Helius Medical Technologies, Inc. to Participate in Noble Capital Markets’ Virtual Road Show Series

 

NEWTOWN, Pa., June 08, 2021 (GLOBE NEWSWIRE) — Helius Medical Technologies, Inc. (Nasdaq:HSDT) (TSX:HSM:CA), (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced its participation in Noble Capital Markets’ Virtual Road Show Series, presented by Channelchek, which is scheduled for Thursday, June 10, 2021.

The event will feature a corporate presentation followed by a Q&A session proctored by Noble Capital Markets’ Senior Research Analyst, Joe Gomes, featuring questions submitted by the audience.

The live webcast of the event is scheduled for June 10, 2021, at 1:00 p.m. Eastern. Register for the webcast here. A recording will be available on Channelchek and under the ‘Events’ section of the Helius Medical Technologies investor relations website at https://heliusmedical.com/index.php/investor-relations/events/upcoming-events.

About
Helius Medical Technologies, Inc.

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 (PoNS
^TM). For more information, visit www.heliusmedical.com.

About the PoNS^TM Device and PoNS Treatment^TM

The Portable Neuromodulation Stimulator (PoNS^TM) is an innovative non-surgical device, inclusive of a controller and mouthpiece, which delivers electrical stimulation to the surface of the tongue to provide treatment of gait deficit. The PoNS device is indicated for use in the United States as a short term treatment of gait deficit due to mild-to-moderate symptoms from multiple sclerosis (“MS”) and is to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over by prescription only. It is authorized for sale in Canada as a class II, non-implantable, medical device intended as a short term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from MS, and chronic balance deficit due to mild-to-moderate traumatic brain injury (“mmTBI”) and is to be used in conjunction with physical therapy. The PoNS^TM is an investigational medical device in the European Union (“EU”) and Australia (“AUS”). It is currently under premarket review by the AUS Therapeutic Goods Administration.

Investor Relations Contact:

Westwicke Partners on behalf of Helius Medical Technologies, Inc.
Jack Powell, Vice President
investorrelations@heliusmedical.com

Noble Capital Markets Senior Research Analyst Robert LeBoyer sits down with Cocrystal Pharma Interim Co-CEO & President Sam Lee and Interim Co-CEO & CFO James Martin for this exclusive interview. Research, News, and Advanced Market Data on COCP View all C-Suite Interviews About Cocrystal Pharma Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics as treatments for serious and/or chronic viral diseases. We employ unique structure-based technologies and Nobel Prize winning expertise to create first- and best-in-class antiviral drugs. These technologies are designed to efficiently deliver small molecule therapeutics that are safe, effective, and convenient to administer. We have identified promising preclinical antiviral therapeutics that target the replication process of influenza virus, SARS-CoV-2 virus, and norovirus and have completed a Phase 2a trial targeting the hepatitis C virus.

Helius Medical Technologies, Inc. to Participate in Noble Capital Markets’ Virtual Road Show Series

 

NEWTOWN, Pa., June 08, 2021 (GLOBE NEWSWIRE) — Helius Medical Technologies, Inc. (Nasdaq:HSDT) (TSX:HSM:CA), (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced its participation in Noble Capital Markets’ Virtual Road Show Series, presented by Channelchek, which is scheduled for Thursday, June 10, 2021.

The event will feature a corporate presentation followed by a Q&A session proctored by Noble Capital Markets’ Senior Research Analyst, Joe Gomes, featuring questions submitted by the audience.

The live webcast of the event is scheduled for June 10, 2021, at 1:00 p.m. Eastern. Register for the webcast here. A recording will be available on Channelchek and under the ‘Events’ section of the Helius Medical Technologies investor relations website at https://heliusmedical.com/index.php/investor-relations/events/upcoming-events.

About
Helius Medical Technologies, Inc.

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 (PoNS
^TM). For more information, visit www.heliusmedical.com.

About the PoNS^TM Device and PoNS Treatment^TM

The Portable Neuromodulation Stimulator (PoNS^TM) is an innovative non-surgical device, inclusive of a controller and mouthpiece, which delivers electrical stimulation to the surface of the tongue to provide treatment of gait deficit. The PoNS device is indicated for use in the United States as a short term treatment of gait deficit due to mild-to-moderate symptoms from multiple sclerosis (“MS”) and is to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over by prescription only. It is authorized for sale in Canada as a class II, non-implantable, medical device intended as a short term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from MS, and chronic balance deficit due to mild-to-moderate traumatic brain injury (“mmTBI”) and is to be used in conjunction with physical therapy. The PoNS^TM is an investigational medical device in the European Union (“EU”) and Australia (“AUS”). It is currently under premarket review by the AUS Therapeutic Goods Administration.

Investor Relations Contact:

Westwicke Partners on behalf of Helius Medical Technologies, Inc.
Jack Powell, Vice President
investorrelations@heliusmedical.com

Tatiana Bulyonkova (Flickr)

From Trippy Drugs to Therapeutic Aids – How Psychedelics Got Their Groove Back

 

For many years, drugs such as LSD, psilocybin and Dimethyltryptamine (DMT) were viewed only as highly dangerous drugs. However, in recent years they have had a bit of rebrand. Now they’re believed by some to have the power to heal, to reconnect us with nature – even resolve political tensions.

Use of these drugs is on the rise. At the start of the pandemic in 2020, the UK Home Office released data showing a 230% rise in confiscations of LSD compared to the previous year. The pandemic itself might be changing drug preferences. Almost half of those using magic mushrooms reported using more during the pandemic according to a recent survey.

The changing view of psychedelics can in part be attributed to the renewed interest in their potential to treat mental health problems such as depression. Between the early 1950s and 1970s, there was a great deal of interest in the use of LSD in the treatment for a wide range of conditions, including alcohol use disorders, schizophrenia, childhood autism and “sexual dysfunction”.

Despite some promising findings, a lack of scientific rigor and wider political and cultural pressures meant that almost all research ended in America in the late 1960s, although it has continued in Europe.

 

 

This work has now started up again to a limited extent. As demonstrated with medicinal cannabis, emphasising the therapeutic potential of a drug can help shift attitudes towards it. In recent years, as research activity has increased, media attention has moved from the risks associated with psychedelics to their potential benefits. This has helped reshape attitudes towards this group of drugs.

 

Mind Altering

The gradual rebrand of psychedelics, from dangerous to therapeutic, has been bolstered by a booming wellbeing industry. An increasing number of people are looking for ways they can extend the mind, body and soul. This has led to a rise in companies selling herbal remedies (as seen with the popularity of turmeric touted as “nature’s-wonder drug”) and now even psychedelics.

Before the pandemic, psychedelic tourism was a growing niche of wellbeing. One popular strand was ayahuasca retreats in South America, which attracted thousands of wealthy customers keen to explore their psyche.

Ayahuasca has been used in traditional healing and spiritual practices for generations by South American indigenous populations. The potent brew contains DMT, the active ingredient that produces a powerful psychedelic experience. For a few thousand pounds, travelers can engage in this practice and claim these celebrity-endorsed rituals as their own to address their physical, psychological, and spiritual maladies.

While some are seeking spiritual awakening, others are using psychedelics to boost brain function.

Microdosing psychedelics, which involves taking small doses of the drug, has also grown in popularity. The aim is to enhance cognitive performance without the disruption of a full-blown experience. People who engage in the practice claim it makes them more productive, creative, and focused. The practice has been enthusiastically reported and promoted in media, despite little evidence of its effectiveness.

This has also helped reshape the image of psychedelics, with a focus on benefits – including savings to healthcare services – rather than the risk of harm. Access to psychedelics has never been easier via the internet and dark web markets.

Likewise, the recent decision by legislators in the US to reduce penalties for possession of small quantities of magic mushrooms reflects the view that these substances are potentially therapeutic, distinct from many other controlled drugs that are discussed in relation to the harms that they can potentially cause.

 

 

Big Business

Private industry, sensing a shift in attitudes and seeing there are profits to be made from legal cannabis in the US, are now setting their sights on psychedelics.

New companies have started up, supported by experienced investors and tech billionaires and advised by leading psychedelic researchers. The initial focus has been on patenting new techniques for synthesizing psychedelic drugs and establishing private medical clinics and therapies to distinguish medical uses from “recreational”.

But as with cannabis, over the long term, as attitudes continue to shift, big money is also likely to be made in non-medical and wellness markets.

While we’re unlikely to see psilocybin hummus on our shelves, “wellness” is a trillion-dollar global industry. Whether that’s home microdosing kits, spiritual retreats, or “therapies” for people feeling lost and without direction, where there’s a disposable income, there’s a psychedelics company with an answer.

 

This article was republished with permission
from The Conversation, a news site dedicated to sharing
ideas from academic experts.  Written by Ian Hamilton Associate Professor of Addiction., University of York and
Harry Sumnall, Professor in Substance Use, Liverpool John Moores University

 

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electroCore Completes Sale of $1.4 Million of NJ NOL Tax Benefits

 

ROCKAWAY, NJ, 
June 09, 2021 (GLOBE NEWSWIRE) — 
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced that it has completed the sale of 
$1.4 million of its available tax benefits through the New Jersey Economic Development Authority’s Technology Business Tax Certificate Transfer program for fiscal years 2019 and 2020. As a result, the Company has received approximately 
$1.4 million in non-dilutive cash from the sale of these net operating loss (NOL) tax benefits.

“This transaction strengthens our balance sheet and further improves our cash position,” commented  Brian Posner, Chief Financial Officer of electroCore. “The funding will extend our efforts in commercializing gammaCore and fortify our ability to expand our non-invasive vagus nerve stimulation (nVNS) therapy into new markets.”

The New Jersey Technology Business Tax Certificate Transfer program enables qualified, NJ-based technology or biotechnology companies with NOLs and fewer than 225 U.S. employees to sell a percentage of their NOL tax credits to unrelated profitable corporations. NOLs may be sold for at least 80 percent of their value, up to a maximum lifetime benefit of 
$15 million per business. This allows qualifying technology and biotechnology companies with NOLs to turn tax losses and credits into cash proceeds to fund their growth and operations, including research and development or other allowable expenditures.

About electroCore, Inc.

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

For more information, visit www.electrocore.com.

About gammaCore^TM

gammaCore^TM (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 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 pacemaker, hearing aid implant, or 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 of age)
  • Pregnant women
  • Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia

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

Forward-looking statement
This press release 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 regarding electroCore’s business prospects, its sales and marketing and product development plans, future cash flow projections, anticipated costs, its product portfolio or potential markets for its technologies, the availability and impact of payor coverage, the potential of nVNS generally and gammaCore in particular to treat COVID-19, and other statements that are not historical in nature, particularly those using terminology such as “anticipates,” “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 obtain additional financing necessary to continue electroCore’s business, sales and marketing and product development plans, the uncertainties inherent in the development of new products or technologies, the ability to successfully commercialize gammaCore™, competition in the industry in which electroCore operates and general market conditions. All forward-looking statements are made as of the date of this press release, and electroCore undertakes no obligation to update 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 refer to all information set forth in this document and should also refer to the disclosure of risk factors 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:
Summer Diaz
electroCore
816-401-6333
summer.diaz@electrocore.com