Neovasc Inc. Reports Results of Annual General Meeting of Shareholders

 

Vancouver, BC, Canada – (NewMediaWire) – June 3, 2021 – Neovasc Inc.(Neovasc or the Company) (NASDAQ, TSX: NVCN) is pleased to announce the results of the votes on matters considered at its Annual General Meeting of Shareholders held on June 3, 2021 in Vancouver, B.C. (the Meeting).

At the Meeting, the shareholders of the Company (the Shareholders) re-elected board members Steven Rubin, Paul Geyer, Doug Janzen, Norman Radow, Alexei Marko and Fred Colen to serve in office until the next annual meeting or until their successors are duly elected or appointed. Detailed results of the voting in respect of the election of directors are as follows:

Nominee	Votes For	% Votes For	Votes Withheld	% Votes Withheld
Steven Rubin	6,318,465	94.48%	369,431	5.52%
Paul Geyer	6,410,453	95.85%	277,431	4.15%
Doug Janzen	6,332,243	94.68%	355,653	5.32%
Norman Radow	6,410,462	95.85%	277,434	4.15%
Alexei Marko	6,320,514	94.51%	367,382	5.49%
Fred Colen	6,174,668	92.33%	513,228	7.67%

At the Meeting, the Shareholders also approved the unallocated options under the Company’s stock option plan (90.49% of votes cast in favor) and re-appointed Grant Thornton LLP, Chartered Accountants as auditors of the Company.

About Neovasc Inc.

Neovasc is a specialty medical device company that develops, manufactures and markets products for the rapidly growing cardiovascular marketplace. Its products include Reducer, for the treatment of refractory angina, which is not currently commercially available in the United States and has been commercially available in Europe since 2015, and TiaraTM for the transcatheter treatment of mitral valve disease, which is currently under clinical investigation in the United States, Canada, Israel and Europe. For more information, visit: www.neovasc.com

Investors

Mike Cavanaugh
Westwicke/ICR

Phone: +1.646.877.9641
Mike.Cavanaugh@westwicke.com

Media

Sean Leous
Westwicke/ICR

Phone: +1.646.866.4012
Sean.Leous@icrinc.com

Forward-Looking Statement Disclaimer

Certain statements in this news release contain forward-looking
statements within the meaning of the U.S. Private Securities Litigation Reform
Act of 1995 and applicable Canadian securities laws that may not be based on
historical fact. When used herein, the words “expect”,
“anticipate”, “estimate”, “may”,
“will”, “should”, “intend,” “believe”,
and similar expressions, are intended to identify forward-looking statements.
Forward-looking statements may involve but are not limited to, expectations as
to the growing cardiovascular marketplace. Forward-looking statements are based
on estimates and assumptions made by the Company in light of its experience and
its perception of historical trends, current conditions and expected future
developments, as well as other factors that the Company believes are
appropriate in the circumstances. Many factors could cause the Company’s actual
results, performance or achievements to differ materially from those expressed
or implied by the forward looking statements, including those described in the
“Risk Factors” section of the Company’s Annual Information Form and
in the Management’s Discussion and Analysis for the three months ended March
31, 2021 (copies of which may be obtained at www.sedar.com or www.sec.gov). These factors should be considered
carefully, and readers should not place undue reliance on the Company’s
forward-looking statements. The Company has no intention and undertakes no
obligation to update or revise any forward-looking statements, whether as a
result of new information, future events or otherwise.

Neovasc Inc. Reports Results of Annual General Meeting of Shareholders

 

Vancouver, BC, Canada – (NewMediaWire) – June 3, 2021 – Neovasc Inc.(Neovasc or the Company) (NASDAQ, TSX: NVCN) is pleased to announce the results of the votes on matters considered at its Annual General Meeting of Shareholders held on June 3, 2021 in Vancouver, B.C. (the Meeting).

At the Meeting, the shareholders of the Company (the Shareholders) re-elected board members Steven Rubin, Paul Geyer, Doug Janzen, Norman Radow, Alexei Marko and Fred Colen to serve in office until the next annual meeting or until their successors are duly elected or appointed. Detailed results of the voting in respect of the election of directors are as follows:

Nominee	Votes For	% Votes For	Votes Withheld	% Votes Withheld
Steven Rubin	6,318,465	94.48%	369,431	5.52%
Paul Geyer	6,410,453	95.85%	277,431	4.15%
Doug Janzen	6,332,243	94.68%	355,653	5.32%
Norman Radow	6,410,462	95.85%	277,434	4.15%
Alexei Marko	6,320,514	94.51%	367,382	5.49%
Fred Colen	6,174,668	92.33%	513,228	7.67%

At the Meeting, the Shareholders also approved the unallocated options under the Company’s stock option plan (90.49% of votes cast in favor) and re-appointed Grant Thornton LLP, Chartered Accountants as auditors of the Company.

About Neovasc Inc.

Neovasc is a specialty medical device company that develops, manufactures and markets products for the rapidly growing cardiovascular marketplace. Its products include Reducer, for the treatment of refractory angina, which is not currently commercially available in the United States and has been commercially available in Europe since 2015, and TiaraTM for the transcatheter treatment of mitral valve disease, which is currently under clinical investigation in the United States, Canada, Israel and Europe. For more information, visit: www.neovasc.com

Investors

Mike Cavanaugh
Westwicke/ICR

Phone: +1.646.877.9641
Mike.Cavanaugh@westwicke.com

Media

Sean Leous
Westwicke/ICR

Phone: +1.646.866.4012
Sean.Leous@icrinc.com

Forward-Looking Statement Disclaimer

Certain statements in this news release contain forward-looking
statements within the meaning of the U.S. Private Securities Litigation Reform
Act of 1995 and applicable Canadian securities laws that may not be based on
historical fact. When used herein, the words “expect”,
“anticipate”, “estimate”, “may”,
“will”, “should”, “intend,” “believe”,
and similar expressions, are intended to identify forward-looking statements.
Forward-looking statements may involve but are not limited to, expectations as
to the growing cardiovascular marketplace. Forward-looking statements are based
on estimates and assumptions made by the Company in light of its experience and
its perception of historical trends, current conditions and expected future
developments, as well as other factors that the Company believes are
appropriate in the circumstances. Many factors could cause the Company’s actual
results, performance or achievements to differ materially from those expressed
or implied by the forward looking statements, including those described in the
“Risk Factors” section of the Company’s Annual Information Form and
in the Management’s Discussion and Analysis for the three months ended March
31, 2021 (copies of which may be obtained at www.sedar.com or www.sec.gov). These factors should be considered
carefully, and readers should not place undue reliance on the Company’s
forward-looking statements. The Company has no intention and undertakes no
obligation to update or revise any forward-looking statements, whether as a
result of new information, future events or otherwise.

Friday, June 04, 2021

Avivagen Inc. (VIVXF)(VIV:CA)
Reports 2Q21 Results, Momentum Continues to Build

Avivagen Inc is a Canadian based company operating in the healthcare sector. It develops science-based, natural health products for animals. It develops and commercializes products for livestock feeds to replace antibiotics for growth promotion and to help prevent disease by supporting the animal’s own health defenses. Its product range includes OxC-beta, Vivamune health chews, Oximunol chewable tablets, and Carotenoid Oxidation products.

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

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

2Q21 Results. For the fiscal second quarter ended April 30th, Avivagen reported revenue of $159,614 and a net loss of $2.2 million, or a loss of $0.04 per share. This compares to revenue of $29,625 and a net loss of $1.4 million, or $0.03 per share, in the same period last year. We had forecast revenue of $550,000 and a net loss of $1.3 million, or a loss of $0.02 per share.


Timing is Everything.  As with most early stage revenue companies, the timing of orders can have an outsized impact on quarterly results, and we believe this is what happened in the quarter when comparing actual results to our projections. In the broader picture, the miss is not material, as long as we continue to see building momentum going forward. The bottom line miss is related to $665,203 …

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. 

Avivagen Inc. Announces Results for the Second Quarter Ending April 30, 2021

 

• Record 64.5 tonne order for OxC-betaTM Livestock over 18 months
• New expansion efforts and customer wins in Central and South America
• Launch of first product for human health.

Ottawa, ON /Business Wire/ June 2, 2021/ Avivagen Inc. (TSXV:VIV, OTCQB:VIVXF) (“Avivagen”), a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications that safely enhances feed intake and supports immune function, thereby supporting general health and performance, has announced its unaudited financial results for the second quarter of 2021.

Milestones achieved in Q2 2021 include:
• Secured its largest recurring order to date for OxC-betaTM Livestock, an 18-month contract at four tonnes per month for use in Mexico. The 64.5 tonne total order is the largest to date in both size and length of contract, and a direct result of the Meyenberg International Group agreement finalized in Q2.
• Selected Meyenberg International Group to spearhead expansion efforts in Central and South America.
• In conjunction with Mimi’s Rock Corp., announced the launch of Dr. Tobias Beta Blend on Amazon.com – Avivagen’s first product designed for human consumption.
• Announced the closing of its oversubscribed $7.5 million bought deal unit offering.
• Announced the publication of its New Zealand OxC-betaTM Livestock dairy trial for use against sub-clinical mastitis in the New Zealand Veterinary Journal, and its upcoming publication of research highlighting the benefits of OxC-betaTM Livestock for Broiler Poultry in Poultry Science.

Since the end of the quarter Avivagen also announced it had:
• Secured a new customer win in Western Mexico.
• Terminated its previous exclusive U.S. sales and distribution agreement and initiated discussions with potential partners to ramp up sales efforts in the lucrative region.
• Recorded its first order from Brazil, received on May 28, 2021.
• Secured first order with major swine and poultry producer in Thailand following numerous trials.

Second Quarter April 30, 2021, Financial Results
The Company’s unaudited Financial Statements for the second quarter ended April 30, 2021 and the accompanying Management’s Discussion and Analysis have been filed on the System for Electronic Document Analysis and Retrieval and are available via its website (www.sedar.com). The financial information for the second quarter ended April 30, 2021, should be read in conjunction with the Company’s unaudited Financial Statements as well as its Management’s Discussion and Analysis for the second quarter ended April 30, 2021.

The Company reported revenues of $159,614 ($29,625 in the quarter ending April 30, 2020) and a comprehensive loss of $(2,197,649) for the quarter ending April 30, 2021. This compares to a comprehensive loss in the quarter ending April 30, 2020 of $(1,393,497).

As reported in the statements of cash flows, the April 30, 2021 quarter comprehensive loss of $(2,197,649) consists of $1,181,373 in non-cashflow items such as share-based payment expense, depreciation, and adjustments to the Company’s ACOA loans. The Company reported $724,505 in interest accretion and adjustments related to the ACOA loans as a result of an increase in management’s estimate of future revenues. As noted, this ACOA adjustment is a non-cash adjustment in the quarter ending April 30, 2021.

The ACOA loans are interest-free and repayments are calculated as 10% of the future revenues and are payable on June 30th of each year. The carrying value has been discounted using a rate of 35% based on the expected timing and amounts of future repayments of the loans. Consequently, the carrying value of the ACOA loans requires regular assessment and adjustment based on management’s estimate of future revenues, with any adjustment being recorded as finance cost on the statement of comprehensive income with an equal increase in the ACOA debt liability on the statement of financial position. In light of the recent press releases announcing future and recurring order for customers in Mexico, Philippines, and Thailand, management increased its estimate of future revenues and therefore adjusted the carrying value of the ACOA loans accordingly.

The Company’s working capital increased by $949,353 as management invested in additional volumes of inventory to support future sales and increased prepaids expenses and trade receivables.

As at April 30, 2021, the Company reported total assets of $5,985,104 (current assets of $5,675,117), total liabilities of $7,163,307, and shareholders’ deficit of ($1,178,203).

Significant financing inflows during the quarter ending April 30, 2021, was an offering of 15,000,000 units of the Company at $0.50 per unit for aggregate gross proceeds of $7,500,000. The offering closed on February 16th, 2021.

Each unit consisted of one common share in the capital of the Company (each a “Common Share”) and one half of one Common Share purchase warrant (each whole warrant, a “Warrant”). Each Warrant will be exercisable to acquire one Common Share until February 16, 2024 at an exercise price of $0.75 per share. The net proceeds of the Offering have been and will be used to fund research and development expenses, sales and marketing costs, product registration, interest expense, working capital and general corporate purposes.

About Avivagen
Avivagen is a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications that, by safely supporting immune function, promote general health and performance. It is a public corporation traded on the TSX Venture Exchange under the symbol VIV and is headquartered in Ottawa, Canada, based in partnership facilities of the National Research Council of Canada. For more information, visit www.avivagen.com. The contents of the website are expressly not incorporated by reference in this press release.

About OxC-beta™ Technology and OxC-beta™ Livestock
Avivagen’s OxC-beta™ technology is derived from Avivagen discoveries about ?-carotene and other carotenoids, compounds that give certain fruits and vegetables their bright colours. Through support of immune function the technology provides a non-antibiotic means of promoting health and growth. OxC-beta™ Livestock is a proprietary product shown to be an effective and economic alternative to the antibiotics commonly added to livestock feeds. The product is currently available for sale in the United States, Philippines, Mexico, Taiwan, New Zealand, Thailand, Brazil, Australia, and Malaysia.

Avivagen’s OxC-beta™ Livestock product is safe, effective and could fulfill the global mandate to remove all in-feed antibiotics as growth promoters. Numerous international livestock trials with poultry and swine using OxC-beta™ Livestock have proven that the product performs as well as, and, sometimes, in some aspects, better than in-feed antibiotics.

Forward Looking Statements
This news release includes certain forward-looking statements that are based upon the current expectations of management. Forward-looking statements involve risks and uncertainties associated with the business of Avivagen Inc. and the environment in which the business operates. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking, including those identified by the expressions “aim”, “anticipate”, “appear”, “believe”, “consider”, “could”, “estimate”, “expect”, “if”, “intend”, “goal”, “hope”, “likely”, “may”, “plan”, “possibly”, “potentially”, “pursue”, “seem”, “should”, “whether”, “will”, “would” and similar expressions. Statements set out in this news release relating to Avivagen’s expectations as to future growth and results, the anticipated continuation of shipments to customers based on recurring orders, future plans for sales in the United States, the planned use of proceeds of the financing discussed above, Avivagen’s expectations as to growth in demand for Avivagen’s products, the possibility for OxC-beta™ Livestock to replace antibiotics in livestock feeds as well as fill a critical need for health support in certain livestock applications where antibiotics are precluded and the size of market opportunities are all forward-looking statements. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results or events to differ materially from current expectations. For instance, initial orders may not result in new orders for Avivagen’s products, despite receipt of the purchase order timing, delivery or fulfilment of orders of product could be delayed for a number of reasons, some of which are outside of Avivagen’ s control, which could result in anticipated revenues from such sales being delayed or in the most serious cases eliminated, actions taken by Avivagen’ s customers and factors affecting the business and financial viability of Avivagen’ s customers can have a negative impact on the expectation of future sales and revenues, customer plans may change due to many reasons, demand for Avivagen’s products may not continue to grow and could decline, Avivagen’s products may not gain market acceptance or regulatory approval in new jurisdictions or for new applications and may not be widely accepted as a replacement for antibiotics in livestock feeds, in each case due to many factors, many of which are outside of Avivagen’s control. Readers are referred to the risk factors associated with the business of Avivagen set out in Avivagen’s most recent management’s discussion and analysis of financial condition available at www.SEDAR.com. Except as required by law, Avivagen assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those reflected in the forward-looking statements.

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.

For more information:
Avivagen Inc.
Drew Basek
Director of Investor Relations
100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6 Phone: 416-540-0733
E-mail: d.basek@avivagen.com

Kym Anthony
Chief Executive Officer
100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6 Head Office Phone: 613-949-8164
Website: www.avivagen.com
Copyright © 2021 Avivagen Inc. OxC-beta™ is a trademark of Avivagen Inc.

Ocugen Expands COVAXIN™ Commercialization Rights to Include Canada

 

• Ocugen to have exclusive co-development, manufacturing, and commercialization rights to COVAXIN™ in Canada, in addition to its existing US rights
  

MALVERN, Pa. and HYDERABAD, India, June 03, 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, and Bharat Biotech, a global leader in vaccine innovation, today announced that they have entered into an amendment to their Co-development, Supply, and Commercialization Agreement to expand Ocugen’s exclusive territory to commercialize COVAXIN™ to now also include Canada, in addition to Ocugen’s existing rights to commercialize COVAXIN™ in the United States.

“This amendment to expand our rights to commercialize COVAXIN™ into Canada speaks to our strong relationship with Bharat Biotech and our joint dedication to bring this unique yet traditional vaccine to additional countries. As we work towards the submission of the emergency use application in the US, we will simultaneously seek authorization under interim order for emergency use in Canada. We believe COVAXIN™ has the potential to play a key role in saving lives from COVID-19 in the US and Canada, as well as across the globe, due to the strong immune response it generates against multiple antigens,” said Dr. Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and Co-founder of Ocugen.

“COVAXIN™ has demonstrated an excellent safety record in human clinical trials and in vaccine administration under emergency use in India. Our goal for all vaccines developed at Bharat Biotech is to provide global access. With its potential effectiveness against multiple existing and emerging variants, we believe that COVAXIN™ is an important vaccine for everyone, including children, based on its unique yet traditional vaccine platform. We are diligently working with Ocugen to bring COVAXIN™ to the US market and now to the Canadian market,” said Dr. Krishna Ella, Chairman & Managing Director of Bharat Biotech.

As consideration for Bharat Biotech’s grant of the rights to commercialize COVAXIN™ in Canada, Ocugen will make an upfront payment and milestone payment upon first commercial sale in Canada to Bharat Biotech, in addition to sharing the profit from sales of COVAXIN^TM in Canada. Similar to the US profit share arrangement, Ocugen will retain 45% of the profits from sales of COVAXIN^TM in Canada.

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 UK variant, B.1.1.7, as well as the Indian double mutant variant, B.1.617. 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. market. For more information, please visit http://ocugen.com/

About Bharat Biotech:

Bharat Biotech has established an excellent track record of innovation with more than 140 global patents, a wide product portfolio of more than 16 vaccines, 4 bio-therapeutics, registrations in more than 116 countries, and World Health Organization (WHO) Pre-qualifications. Located in Genome Valley in Hyderabad, India, a hub for the global biotech industry, Bharat Biotech has built a world-class vaccine & bio-therapeutics, research & product development, Bio-Safety Level 3 manufacturing, and vaccine supply and distribution.

Having delivered more than 6 billion doses of vaccines worldwide, Bharat Biotech continues to lead innovation and has developed vaccines for influenza H1N1, Rotavirus, Japanese Encephalitis, Rabies, Chikungunya, Zika and the world’s first tetanus-toxoid conjugated vaccine for Typhoid.

Bharat’s commitment to global social innovation programs and public private partnerships resulted in the introduction of path breaking WHO pre-qualified vaccines BIOPOLIO®, ROTAVAC® and Typbar TCV® combatting polio, rotavirus, typhoid infections, respectively. The recent acquisition of the rabies vaccine facility, Chiron Behring, from GlaxoSmithKline (GSK) has positioned Bharat Biotech as the largest rabies vaccine manufacturer in the world. To learn more about Bharat Biotech visit https://www.bharatbiotech.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 Phase 3 interim data 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 the U.S. Food and Drug Administration (FDA) will be satisfied with the design of and results from preclinical and clinical studies of COVAXIN, which have been conducted by Bharat Biotech in India; whether and when any biologics license and/or emergency use authorization applications may be filed in the United States for COVAXIN and 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 the FDA or Health 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
Lisa DeScenza
ldescenza@lavoiehealthscience.com
+1 9783955970

Lineage Cell Therapeutics To Host Webinar With Therapeutic Area Experts To Discuss Retinal Tissue Restoration Observed In Dry AMD Patients Treated With Opregen®

 

Webinar Scheduled for June 10, 2021 at 4pm Eastern Time / 1pm Pacific Time

CARLSBAD, Calif.–(BUSINESS WIRE)–Jun. 3, 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 plans to host a webinar featuring external therapeutic area experts in age-related macular degeneration (AMD), on 
June 10, 2021 at 
4pm ET /
1pm PT. Lineage recently reported that restoration of retinal tissue has been observed in three patients enrolled in the Company’s Phase 1/2a study of its lead product candidate, OpRegen, an allogeneic retinal pigment epithelium (RPE) cell transplant therapy in development for the treatment of AMD with geographic atrophy (GA), or dry (atrophic) AMD. These new findings occurred in three of the four better baseline vision (Cohort 4) patients for whom surgeons successfully covered the majority of the area of atrophy with a suspension of OpRegen RPE cells. Outer retinal layer restoration, which was observed using high-resolution Optical Coherence Tomography (OCT), was evidenced by the presence of new areas of RPE monolayer with overlying ellipsoid zone, external limiting membrane, and outer nuclear layer, which were not present at the time of baseline assessment. These findings suggest integration of the new RPE cells with functional photoreceptors in areas that previously showed no presence of any of these cells. These effects were most prominent in the transitional areas around the primary area of GA. The webinar will feature therapeutic area experts who will discuss these findings in detail, including a review of anatomical improvements, functional activity, and additional results of treatment with OpRegen. Interested parties can access the webinar on the Events and Presentations section of Lineage’s website.

Therapeutic Area Experts, External Reviewers & Contributors

Eyal Banin, M.D., Ph.D., Director, Center for Retinal and Macular Degenerations (CRMD), Department of Ophthalmology, Hadassah-Hebrew University Medical Center.

Dr. Banin is a graduate of the 
Hebrew University-Hadassah School of Medicine, holds a Ph.D. in Neurobiology from the 
Hebrew University, and completed his ophthalmology residency at 
Hadassah Medical Center. Following a post-doctoral and medical retina fellowship at the University of Pennsylvania’s 
Scheie Eye Institute in 
Philadelphia, he was appointed head of the Medical Retina Service and the CRMD at Hadassah. His main clinical and research focus is in the field of retinal and macular degenerations, including the development and application of novel cell- and gene-based therapies for these diseases. The recipient of many research grants from Israeli and foreign institutions,  Dr. Banin has authored and published over 150 peer-reviewed articles in leading medical and scientific journals.

Jordi Monés, M.D., Ph.D., Director, Institut de la Màcula, Director and Principal Investigator, Barcelona Macula Foundation: Research for Vision.

Dr. Monés is an ophthalmologist, macula and vitreoretinal specialist, and macular and retinal degeneration researcher. Dr. Monés earned his medical degree at the 
University of Barcelona and subsequently specialized in ophthalmology at Barraquer Ophthalmology Centre. He completed his retinal specialist training at the 
Massachusetts Eye and Ear Infirmary at 
Harvard University, and at Hospital San José, 
Monterrey Institute of Technology and Higher Education. He earned his PhD degree in Medicine and Surgery at the 
University of Barcelona. Dr Monés is dedicated to fighting blindness by supporting and conducting research in retinal disease. For the last 15 years he has been one of the foremost researchers involved in clinical trials for the treatment of age-related macular degeneration. He is currently conducting Phase I, II and III clinical trials. His work has been widely published in scientific journals and he has given more than 200 presentations at international congresses. He is a member of 12 scientific societies.

Brandon Lujan, M.D., Associate Professor of Ophthalmology, School of Medicine, OHSU Casey Eye Institute.

Dr. Lujan is a medical retina specialist, scientist, and Director of the Casey Reading Center. Dr. Lujan’s area of expertise is Optical Coherence Tomography (OCT) retinal imaging, and he is the first-named inventor and co-developer of Directional OCT, a technique and device capable of creating optical contrast in photoreceptors.  Dr. Lujan has published and spoken internationally on diagnosis and management of macular diseases and has brought that expertise to bear on clinical trials. He is the creator of OCTMD, an educational resource focused on the present and future of OCT.  Dr. Lujan is a member of the 
Macula Society, 
Retina Society, the 
Association for Research and Vision in Ophthalmology, and the 
American Society of Retina Specialists.

Christopher D. Riemann, M.D., Vitreoretinal Surgeon and Fellowship Director, Cincinnati Eye Institute (CEI) and University of Cincinnati School of Medicine.

In collaboration with the other retinal surgeons at CEI,  Dr. Riemann is a principal investigator or co-investigator for many Phase II and Phase III clinical trials. He specializes in medical and surgical vitreoretinal diseases including diabetic retinopathy, macular degeneration, retinal detachment, retinopathy of prematurity, vascular diseases of the retina, uveitis, histoplasmosis, complications of anterior segment surgery, endoscopic posterior segment surgery, and ocular trauma.  Dr. Riemann is a member of the 
American Society of Retina Specialists, 
American Academy of Ophthalmology, 
Ohio State Medical Association, 
Cincinnati Academy of Medicine, 
Cincinnati Ophthalmology Society, and the 
Association for Research in Vision and Ophthalmology. His original research in the fields of Ophthalmology, Cardiology, and Endocrinology has been published in international peer reviewed scientific journals and has been presented at national scientific meetings.  Dr. Riemann has several patents for innovative surgical technologies and enjoys sharing his passion for the blend of engineering and medicine.

Michael S. Ip, M.D., Professor, Department of Ophthalmology at the David Geffen School of Medicine at the University of California – Los Angeles.

Dr. Ip is a member of the 
Doheny Eye Institute and currently serves as the Medical Director of the Doheny Image Reading Center. His research focuses on the design and conduct of clinical trials investigating treatments for diabetic retinopathy, AMD, and retinal venous occlusive disease and other retinal diseases.  Dr. Ip has assisted with the collection, analysis, and dissemination of important primary and secondary outcomes in ophthalmic clinical trials. In 2003,  Dr. Ip was selected to serve as the national protocol chair for the clinical trial conducted by the Diabetic Retinopathy Clinical Research Network (DRCR.net) comparing focal/grid photocoagulation and intravitreal triamcinolone for diabetic macular edema (protocol B). This was a landmark study and changed practice patterns in the field of ophthalmology. In 2003, his independent and investigator-initiated research group received a U-10 cooperative agreement award from the 
National Eye Institute, 
National Institutes of Health to conduct the Standard Care vs Corticosteroid for Retinal Vein Occlusion (SCORE) Study. This was a multicenter, randomized, 
NIH-defined phase 3 trial which led to over 15 publications in the peer-reviewed literature and provided much needed Level 1 evidence to guide our management of retinal venous occlusive disease. In 2013, this group received funding from the NEI to conduct the SCORE2 Study. The SCORE2 Study is an 
NIH-defined phase 3 clinical trial designed to evaluate the comparative efficacy and safety of bevacizumab versus aflibercept for the treatment of macular edema secondary to central retinal vein occlusion. It has been designed to answer several questions of significant public health importance. Currently, this study group has extended the SCORE2 follow up phase to evaluate long-term safety and efficacy outcomes in central retinal vein occlusion.

Allen C. Ho, M.D. FACS, Wills Eye Hospital Attending Surgeon and Director of Retina Research, Professor of Ophthalmology, Thomas Jefferson University.

Dr. Ho maintains special interests in macular diseases, diabetic retinopathy, surgical retinal diseases and clinical trials investigating new treatments for vitreoretinal diseases including gene and cell therapies and new surgical drug delivery devices and techniques. His experience includes collaborative translational and clinical trial clinical research with expertise in study design, methodological testing, data analyses, surgical instrumentation and procedure development, execution and communication of these studies and their study results. He is the current President of The 
Retina Society and serves on its Executive Committee.  Dr. Ho has been Study Chair, Steering Committee Member or Principal Investigator of over 50 clinical trials.  Dr. Ho has served on the 
US FDA Ophthalmic Device Panel, 
American Academy of Ophthalmology (AAO) Ophthalmic Retina Technology Assessment Committee, 
AAO Retina Measures Group, AAO IRIS Registry Committee and is past Chair of the AAO Retina Subspecialty Days and Vail Vitrectomy meetings. Through the Wills Eye Hospital Retina Fellowship he has mentored over 60 retina fellows and international research trainees.  Dr. Ho has authored over 200 peer reviewed publications and several textbooks and is Editor-in-Chief of Current Opinion in Ophthalmology and Chief Medical Editor of Retina Today.

About OpRegen

OpRegen is currently being evaluated in a Phase 1/2a open-label, dose escalation safety and efficacy study of a single injection of human retinal pigment epithelium cells derived from an established pluripotent cell line and transplanted subretinally in patients with advanced dry AMD with GA. The study enrolled 24 patients into 4 cohorts. The first 3 cohorts enrolled only legally blind patients with Best Corrected Visual Acuity (BCVA) of 20/200 or worse. The fourth cohort enrolled 12 better vision patients (BCVA from 20/65 to 20/250 with smaller mean areas of GA). Cohort 4 also included patients treated with a new “thaw-and-inject” formulation of OpRegen, which can be shipped directly to sites and used immediately upon thawing, removing the complications and logistics of having to use a dose preparation facility. The primary objective of the study is to evaluate the safety and tolerability of OpRegen as assessed by the incidence and frequency of treatment emergent adverse events. Secondary objectives are to evaluate the preliminary efficacy of OpRegen treatment by assessing the changes in ophthalmological parameters measured by various methods of primary clinical relevance. OpRegen is a registered trademark of 
Cell Cure Neurosciences Ltd., a majority-owned subsidiary of 
Lineage Cell Therapeutics, Inc.

About Age-Related Macular Degeneration

Age-related macular degeneration (AMD) is an eye disease that can blur the sharp, central vision in patients and is the leading cause of vision loss in people over the age of 60. There are two forms of AMD: dry (atrophic) AMD and wet (neovascular) AMD. Dry (atrophic) AMD is the more common of the two forms, accounting for approximately 85-90% of all cases. In atrophic AMD, parts of the macula get thinner with age and accumulations of extracellular material between Bruch’s membrane and the RPE, known as drusen, increase in number and volume, leading to a progressive loss of central vision, typically in both eyes. Global sales of the two leading wet AMD therapies were in excess of 
$10 billion in 2019. Nearly all cases of wet AMD eventually will develop the underlying atrophic AMD if the newly formed blood vessels are treated correctly. There are currently no 
U.S. Food and Drug Administration, or 
European Medicines Agency, approved treatment options available for patients with atrophic AMD.

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.

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.

PDS Biotechnology Expands VERSATILE-002 study of PDS0101 and KEYTRUDA® in Advanced Head and Neck Cancer to Include Patients Who Have Failed Prior Treatment with Checkpoint Inhibitors

 

FLORHAM PARK, N.J., June 03, 2021 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune^® T-cell activating technology, today announced the protocol amendment to expand its Phase 2 VERSATILE-002 study to include patients, in an additional arm, who have failed prior checkpoint inhibitor (CPI) therapy (CPI refractory patients). The VERSATILE-002 study is designed to evaluate PDS0101 in combination with KEYTRUDA
^® (pembrolizumab) in the treatment of advanced human papillomavirus (HPV)-associated head and neck cancer and is currently being run at approximately 20 clinical sites in the US.

VERSATILE-002 was initially opened to checkpoint inhibitor naive HPV16-associated head and neck cancer patients in first line treatment of recurrent or metastatic cancer.   The trial is actively recruiting patients who have the option to receive the two immunotherapies rather than chemotherapy as their first line of treatment for recurrent disease. The additional study arm will evaluate the objective response to the combination among approximately 40 patients with advanced head and neck cancer who have failed multiple treatments, including checkpoint inhibitor therapy. Objective response is measured by radiographic tumor responses according to RECIST 1.1. In the expansion arm, the first 21 patients will be evaluated for safety and objective response before the arm progresses to full enrollment.

The inclusion of CPI refractory patients in VERSATILE-002 follows the publication of an abstract and subsequent presentation of interim data in another Phase 2 trial (NCT04287868) being led by the National Cancer Institute (NCI) evaluating the combination of PDS0101 (Versamune^®-HPV16) in combination with two investigational immunotherapies. That trial recently reported clinical responses with objective responses (tumor reduction of 30% or more) in 63% (5/8) of HPV16-positive cancer patients who had failed chemotherapy, radiation, and checkpoint inhibitor therapy.

“There is an enormous unmet medical need in advanced head and neck cancer patients who have failed multiple therapies, including chemotherapy, radiation and checkpoint inhibitor therapy. We believe the combination of PDS0101 and KEYTRUDA^® has the potential to significantly improve clinical outcomes for these patients who have limited treatment options,” commented Dr. Lauren Wood, Chief Medical Officer of PDS Biotech.

Dr. Jared Weiss, Associate Professor of Medicine, Division of Oncology, University of North Carolina at Chapel Hill School of Medicine and Lineberger Comprehensive Cancer Center, is serving as the Principal Investigator of this Phase 2 clinical trial in advanced HPV16-associated head and neck cancer. For patients interested in learnings more about this clinical study, please visit the website: https://pdsbiotech.com/versatile-002.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune^® T-cell activating technology platform. Our Versamune^®-based products overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune
^® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. Our immuno-oncology product candidates are initially being studied in combination therapy to potentially enhance efficacy without compounding toxicity across a range of cancer types. The company’s lead investigational cancer immunotherapy product PDS0101 is currently in Phase 2 clinical studies in HPV-associated cancers. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

About PDS0101

PDS Biotech’s lead candidate, PDS0101, combines the utility of the Versamune^® platform with targeted antigens in HPV-expressing cancers.  In partnership with Merck and Co., PDS Biotech is evaluating a combination of PDS0101 and KEYTRUDA^® in a Phase 2 study in first-line treatment of recurrent or metastatic head and neck cancer. PDS Biotech is also conducting two additional Phase 2 studies in advanced HPV-associated cancers and advanced localized cervical cancer with the National Cancer Institute (NCI) and The University of Texas MD Anderson Cancer Center, respectively.

Forward Looking Statements

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

Media & Investor Relations Contact:

Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: drandolph@pdsbiotech.com

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: rich@cg.capital

PDS Biotechnology Expands VERSATILE-002 study of PDS0101 and KEYTRUDA® in Advanced Head and Neck Cancer to Include Patients Who Have Failed Prior Treatment with Checkpoint Inhibitors

 

FLORHAM PARK, N.J., June 03, 2021 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune^® T-cell activating technology, today announced the protocol amendment to expand its Phase 2 VERSATILE-002 study to include patients, in an additional arm, who have failed prior checkpoint inhibitor (CPI) therapy (CPI refractory patients). The VERSATILE-002 study is designed to evaluate PDS0101 in combination with KEYTRUDA
^® (pembrolizumab) in the treatment of advanced human papillomavirus (HPV)-associated head and neck cancer and is currently being run at approximately 20 clinical sites in the US.

VERSATILE-002 was initially opened to checkpoint inhibitor naive HPV16-associated head and neck cancer patients in first line treatment of recurrent or metastatic cancer.   The trial is actively recruiting patients who have the option to receive the two immunotherapies rather than chemotherapy as their first line of treatment for recurrent disease. The additional study arm will evaluate the objective response to the combination among approximately 40 patients with advanced head and neck cancer who have failed multiple treatments, including checkpoint inhibitor therapy. Objective response is measured by radiographic tumor responses according to RECIST 1.1. In the expansion arm, the first 21 patients will be evaluated for safety and objective response before the arm progresses to full enrollment.

The inclusion of CPI refractory patients in VERSATILE-002 follows the publication of an abstract and subsequent presentation of interim data in another Phase 2 trial (NCT04287868) being led by the National Cancer Institute (NCI) evaluating the combination of PDS0101 (Versamune^®-HPV16) in combination with two investigational immunotherapies. That trial recently reported clinical responses with objective responses (tumor reduction of 30% or more) in 63% (5/8) of HPV16-positive cancer patients who had failed chemotherapy, radiation, and checkpoint inhibitor therapy.

“There is an enormous unmet medical need in advanced head and neck cancer patients who have failed multiple therapies, including chemotherapy, radiation and checkpoint inhibitor therapy. We believe the combination of PDS0101 and KEYTRUDA^® has the potential to significantly improve clinical outcomes for these patients who have limited treatment options,” commented Dr. Lauren Wood, Chief Medical Officer of PDS Biotech.

Dr. Jared Weiss, Associate Professor of Medicine, Division of Oncology, University of North Carolina at Chapel Hill School of Medicine and Lineberger Comprehensive Cancer Center, is serving as the Principal Investigator of this Phase 2 clinical trial in advanced HPV16-associated head and neck cancer. For patients interested in learnings more about this clinical study, please visit the website: https://pdsbiotech.com/versatile-002.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune^® T-cell activating technology platform. Our Versamune^®-based products overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune
^® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. Our immuno-oncology product candidates are initially being studied in combination therapy to potentially enhance efficacy without compounding toxicity across a range of cancer types. The company’s lead investigational cancer immunotherapy product PDS0101 is currently in Phase 2 clinical studies in HPV-associated cancers. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

About PDS0101

PDS Biotech’s lead candidate, PDS0101, combines the utility of the Versamune^® platform with targeted antigens in HPV-expressing cancers.  In partnership with Merck and Co., PDS Biotech is evaluating a combination of PDS0101 and KEYTRUDA^® in a Phase 2 study in first-line treatment of recurrent or metastatic head and neck cancer. PDS Biotech is also conducting two additional Phase 2 studies in advanced HPV-associated cancers and advanced localized cervical cancer with the National Cancer Institute (NCI) and The University of Texas MD Anderson Cancer Center, respectively.

Forward Looking Statements

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

Media & Investor Relations Contact:

Deanne Randolph
PDS Biotech
Phone: +1 (908) 517-3613
Email: drandolph@pdsbiotech.com

Rich Cockrell
CG Capital
Phone: +1 (404) 736-3838
Email: rich@cg.capital

Lineage Cell Therapeutics To Host Webinar With Therapeutic Area Experts To Discuss Retinal Tissue Restoration Observed In Dry AMD Patients Treated With Opregen®

 

Webinar Scheduled for June 10, 2021 at 4pm Eastern Time / 1pm Pacific Time

CARLSBAD, Calif.–(BUSINESS WIRE)–Jun. 3, 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 plans to host a webinar featuring external therapeutic area experts in age-related macular degeneration (AMD), on 
June 10, 2021 at 
4pm ET /
1pm PT. Lineage recently reported that restoration of retinal tissue has been observed in three patients enrolled in the Company’s Phase 1/2a study of its lead product candidate, OpRegen, an allogeneic retinal pigment epithelium (RPE) cell transplant therapy in development for the treatment of AMD with geographic atrophy (GA), or dry (atrophic) AMD. These new findings occurred in three of the four better baseline vision (Cohort 4) patients for whom surgeons successfully covered the majority of the area of atrophy with a suspension of OpRegen RPE cells. Outer retinal layer restoration, which was observed using high-resolution Optical Coherence Tomography (OCT), was evidenced by the presence of new areas of RPE monolayer with overlying ellipsoid zone, external limiting membrane, and outer nuclear layer, which were not present at the time of baseline assessment. These findings suggest integration of the new RPE cells with functional photoreceptors in areas that previously showed no presence of any of these cells. These effects were most prominent in the transitional areas around the primary area of GA. The webinar will feature therapeutic area experts who will discuss these findings in detail, including a review of anatomical improvements, functional activity, and additional results of treatment with OpRegen. Interested parties can access the webinar on the Events and Presentations section of Lineage’s website.

Therapeutic Area Experts, External Reviewers & Contributors

Eyal Banin, M.D., Ph.D., Director, Center for Retinal and Macular Degenerations (CRMD), Department of Ophthalmology, Hadassah-Hebrew University Medical Center.

Dr. Banin is a graduate of the 
Hebrew University-Hadassah School of Medicine, holds a Ph.D. in Neurobiology from the 
Hebrew University, and completed his ophthalmology residency at 
Hadassah Medical Center. Following a post-doctoral and medical retina fellowship at the University of Pennsylvania’s 
Scheie Eye Institute in 
Philadelphia, he was appointed head of the Medical Retina Service and the CRMD at Hadassah. His main clinical and research focus is in the field of retinal and macular degenerations, including the development and application of novel cell- and gene-based therapies for these diseases. The recipient of many research grants from Israeli and foreign institutions,  Dr. Banin has authored and published over 150 peer-reviewed articles in leading medical and scientific journals.

Jordi Monés, M.D., Ph.D., Director, Institut de la Màcula, Director and Principal Investigator, Barcelona Macula Foundation: Research for Vision.

Dr. Monés is an ophthalmologist, macula and vitreoretinal specialist, and macular and retinal degeneration researcher. Dr. Monés earned his medical degree at the 
University of Barcelona and subsequently specialized in ophthalmology at Barraquer Ophthalmology Centre. He completed his retinal specialist training at the 
Massachusetts Eye and Ear Infirmary at 
Harvard University, and at Hospital San José, 
Monterrey Institute of Technology and Higher Education. He earned his PhD degree in Medicine and Surgery at the 
University of Barcelona. Dr Monés is dedicated to fighting blindness by supporting and conducting research in retinal disease. For the last 15 years he has been one of the foremost researchers involved in clinical trials for the treatment of age-related macular degeneration. He is currently conducting Phase I, II and III clinical trials. His work has been widely published in scientific journals and he has given more than 200 presentations at international congresses. He is a member of 12 scientific societies.

Brandon Lujan, M.D., Associate Professor of Ophthalmology, School of Medicine, OHSU Casey Eye Institute.

Dr. Lujan is a medical retina specialist, scientist, and Director of the Casey Reading Center. Dr. Lujan’s area of expertise is Optical Coherence Tomography (OCT) retinal imaging, and he is the first-named inventor and co-developer of Directional OCT, a technique and device capable of creating optical contrast in photoreceptors.  Dr. Lujan has published and spoken internationally on diagnosis and management of macular diseases and has brought that expertise to bear on clinical trials. He is the creator of OCTMD, an educational resource focused on the present and future of OCT.  Dr. Lujan is a member of the 
Macula Society, 
Retina Society, the 
Association for Research and Vision in Ophthalmology, and the 
American Society of Retina Specialists.

Christopher D. Riemann, M.D., Vitreoretinal Surgeon and Fellowship Director, Cincinnati Eye Institute (CEI) and University of Cincinnati School of Medicine.

In collaboration with the other retinal surgeons at CEI,  Dr. Riemann is a principal investigator or co-investigator for many Phase II and Phase III clinical trials. He specializes in medical and surgical vitreoretinal diseases including diabetic retinopathy, macular degeneration, retinal detachment, retinopathy of prematurity, vascular diseases of the retina, uveitis, histoplasmosis, complications of anterior segment surgery, endoscopic posterior segment surgery, and ocular trauma.  Dr. Riemann is a member of the 
American Society of Retina Specialists, 
American Academy of Ophthalmology, 
Ohio State Medical Association, 
Cincinnati Academy of Medicine, 
Cincinnati Ophthalmology Society, and the 
Association for Research in Vision and Ophthalmology. His original research in the fields of Ophthalmology, Cardiology, and Endocrinology has been published in international peer reviewed scientific journals and has been presented at national scientific meetings.  Dr. Riemann has several patents for innovative surgical technologies and enjoys sharing his passion for the blend of engineering and medicine.

Michael S. Ip, M.D., Professor, Department of Ophthalmology at the David Geffen School of Medicine at the University of California – Los Angeles.

Dr. Ip is a member of the 
Doheny Eye Institute and currently serves as the Medical Director of the Doheny Image Reading Center. His research focuses on the design and conduct of clinical trials investigating treatments for diabetic retinopathy, AMD, and retinal venous occlusive disease and other retinal diseases.  Dr. Ip has assisted with the collection, analysis, and dissemination of important primary and secondary outcomes in ophthalmic clinical trials. In 2003,  Dr. Ip was selected to serve as the national protocol chair for the clinical trial conducted by the Diabetic Retinopathy Clinical Research Network (DRCR.net) comparing focal/grid photocoagulation and intravitreal triamcinolone for diabetic macular edema (protocol B). This was a landmark study and changed practice patterns in the field of ophthalmology. In 2003, his independent and investigator-initiated research group received a U-10 cooperative agreement award from the 
National Eye Institute, 
National Institutes of Health to conduct the Standard Care vs Corticosteroid for Retinal Vein Occlusion (SCORE) Study. This was a multicenter, randomized, 
NIH-defined phase 3 trial which led to over 15 publications in the peer-reviewed literature and provided much needed Level 1 evidence to guide our management of retinal venous occlusive disease. In 2013, this group received funding from the NEI to conduct the SCORE2 Study. The SCORE2 Study is an 
NIH-defined phase 3 clinical trial designed to evaluate the comparative efficacy and safety of bevacizumab versus aflibercept for the treatment of macular edema secondary to central retinal vein occlusion. It has been designed to answer several questions of significant public health importance. Currently, this study group has extended the SCORE2 follow up phase to evaluate long-term safety and efficacy outcomes in central retinal vein occlusion.

Allen C. Ho, M.D. FACS, Wills Eye Hospital Attending Surgeon and Director of Retina Research, Professor of Ophthalmology, Thomas Jefferson University.

Dr. Ho maintains special interests in macular diseases, diabetic retinopathy, surgical retinal diseases and clinical trials investigating new treatments for vitreoretinal diseases including gene and cell therapies and new surgical drug delivery devices and techniques. His experience includes collaborative translational and clinical trial clinical research with expertise in study design, methodological testing, data analyses, surgical instrumentation and procedure development, execution and communication of these studies and their study results. He is the current President of The 
Retina Society and serves on its Executive Committee.  Dr. Ho has been Study Chair, Steering Committee Member or Principal Investigator of over 50 clinical trials.  Dr. Ho has served on the 
US FDA Ophthalmic Device Panel, 
American Academy of Ophthalmology (AAO) Ophthalmic Retina Technology Assessment Committee, 
AAO Retina Measures Group, AAO IRIS Registry Committee and is past Chair of the AAO Retina Subspecialty Days and Vail Vitrectomy meetings. Through the Wills Eye Hospital Retina Fellowship he has mentored over 60 retina fellows and international research trainees.  Dr. Ho has authored over 200 peer reviewed publications and several textbooks and is Editor-in-Chief of Current Opinion in Ophthalmology and Chief Medical Editor of Retina Today.

About OpRegen

OpRegen is currently being evaluated in a Phase 1/2a open-label, dose escalation safety and efficacy study of a single injection of human retinal pigment epithelium cells derived from an established pluripotent cell line and transplanted subretinally in patients with advanced dry AMD with GA. The study enrolled 24 patients into 4 cohorts. The first 3 cohorts enrolled only legally blind patients with Best Corrected Visual Acuity (BCVA) of 20/200 or worse. The fourth cohort enrolled 12 better vision patients (BCVA from 20/65 to 20/250 with smaller mean areas of GA). Cohort 4 also included patients treated with a new “thaw-and-inject” formulation of OpRegen, which can be shipped directly to sites and used immediately upon thawing, removing the complications and logistics of having to use a dose preparation facility. The primary objective of the study is to evaluate the safety and tolerability of OpRegen as assessed by the incidence and frequency of treatment emergent adverse events. Secondary objectives are to evaluate the preliminary efficacy of OpRegen treatment by assessing the changes in ophthalmological parameters measured by various methods of primary clinical relevance. OpRegen is a registered trademark of 
Cell Cure Neurosciences Ltd., a majority-owned subsidiary of 
Lineage Cell Therapeutics, Inc.

About Age-Related Macular Degeneration

Age-related macular degeneration (AMD) is an eye disease that can blur the sharp, central vision in patients and is the leading cause of vision loss in people over the age of 60. There are two forms of AMD: dry (atrophic) AMD and wet (neovascular) AMD. Dry (atrophic) AMD is the more common of the two forms, accounting for approximately 85-90% of all cases. In atrophic AMD, parts of the macula get thinner with age and accumulations of extracellular material between Bruch’s membrane and the RPE, known as drusen, increase in number and volume, leading to a progressive loss of central vision, typically in both eyes. Global sales of the two leading wet AMD therapies were in excess of 
$10 billion in 2019. Nearly all cases of wet AMD eventually will develop the underlying atrophic AMD if the newly formed blood vessels are treated correctly. There are currently no 
U.S. Food and Drug Administration, or 
European Medicines Agency, approved treatment options available for patients with atrophic AMD.

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.

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.

Ocugen Expands COVAXIN™ Commercialization Rights to Include Canada

 

• Ocugen to have exclusive co-development, manufacturing, and commercialization rights to COVAXIN™ in Canada, in addition to its existing US rights
  

MALVERN, Pa. and HYDERABAD, India, June 03, 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, and Bharat Biotech, a global leader in vaccine innovation, today announced that they have entered into an amendment to their Co-development, Supply, and Commercialization Agreement to expand Ocugen’s exclusive territory to commercialize COVAXIN™ to now also include Canada, in addition to Ocugen’s existing rights to commercialize COVAXIN™ in the United States.

“This amendment to expand our rights to commercialize COVAXIN™ into Canada speaks to our strong relationship with Bharat Biotech and our joint dedication to bring this unique yet traditional vaccine to additional countries. As we work towards the submission of the emergency use application in the US, we will simultaneously seek authorization under interim order for emergency use in Canada. We believe COVAXIN™ has the potential to play a key role in saving lives from COVID-19 in the US and Canada, as well as across the globe, due to the strong immune response it generates against multiple antigens,” said Dr. Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and Co-founder of Ocugen.

“COVAXIN™ has demonstrated an excellent safety record in human clinical trials and in vaccine administration under emergency use in India. Our goal for all vaccines developed at Bharat Biotech is to provide global access. With its potential effectiveness against multiple existing and emerging variants, we believe that COVAXIN™ is an important vaccine for everyone, including children, based on its unique yet traditional vaccine platform. We are diligently working with Ocugen to bring COVAXIN™ to the US market and now to the Canadian market,” said Dr. Krishna Ella, Chairman & Managing Director of Bharat Biotech.

As consideration for Bharat Biotech’s grant of the rights to commercialize COVAXIN™ in Canada, Ocugen will make an upfront payment and milestone payment upon first commercial sale in Canada to Bharat Biotech, in addition to sharing the profit from sales of COVAXIN^TM in Canada. Similar to the US profit share arrangement, Ocugen will retain 45% of the profits from sales of COVAXIN^TM in Canada.

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 UK variant, B.1.1.7, as well as the Indian double mutant variant, B.1.617. 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. market. For more information, please visit http://ocugen.com/

About Bharat Biotech:

Bharat Biotech has established an excellent track record of innovation with more than 140 global patents, a wide product portfolio of more than 16 vaccines, 4 bio-therapeutics, registrations in more than 116 countries, and World Health Organization (WHO) Pre-qualifications. Located in Genome Valley in Hyderabad, India, a hub for the global biotech industry, Bharat Biotech has built a world-class vaccine & bio-therapeutics, research & product development, Bio-Safety Level 3 manufacturing, and vaccine supply and distribution.

Having delivered more than 6 billion doses of vaccines worldwide, Bharat Biotech continues to lead innovation and has developed vaccines for influenza H1N1, Rotavirus, Japanese Encephalitis, Rabies, Chikungunya, Zika and the world’s first tetanus-toxoid conjugated vaccine for Typhoid.

Bharat’s commitment to global social innovation programs and public private partnerships resulted in the introduction of path breaking WHO pre-qualified vaccines BIOPOLIO®, ROTAVAC® and Typbar TCV® combatting polio, rotavirus, typhoid infections, respectively. The recent acquisition of the rabies vaccine facility, Chiron Behring, from GlaxoSmithKline (GSK) has positioned Bharat Biotech as the largest rabies vaccine manufacturer in the world. To learn more about Bharat Biotech visit https://www.bharatbiotech.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 Phase 3 interim data 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 the U.S. Food and Drug Administration (FDA) will be satisfied with the design of and results from preclinical and clinical studies of COVAXIN, which have been conducted by Bharat Biotech in India; whether and when any biologics license and/or emergency use authorization applications may be filed in the United States for COVAXIN and 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 the FDA or Health 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
Lisa DeScenza
ldescenza@lavoiehealthscience.com
+1 9783955970

Avivagen Inc. Announces Results for the Second Quarter Ending April 30, 2021

 

• Record 64.5 tonne order for OxC-betaTM Livestock over 18 months
• New expansion efforts and customer wins in Central and South America
• Launch of first product for human health.

Ottawa, ON /Business Wire/ June 2, 2021/ Avivagen Inc. (TSXV:VIV, OTCQB:VIVXF) (“Avivagen”), a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications that safely enhances feed intake and supports immune function, thereby supporting general health and performance, has announced its unaudited financial results for the second quarter of 2021.

Milestones achieved in Q2 2021 include:
• Secured its largest recurring order to date for OxC-betaTM Livestock, an 18-month contract at four tonnes per month for use in Mexico. The 64.5 tonne total order is the largest to date in both size and length of contract, and a direct result of the Meyenberg International Group agreement finalized in Q2.
• Selected Meyenberg International Group to spearhead expansion efforts in Central and South America.
• In conjunction with Mimi’s Rock Corp., announced the launch of Dr. Tobias Beta Blend on Amazon.com – Avivagen’s first product designed for human consumption.
• Announced the closing of its oversubscribed $7.5 million bought deal unit offering.
• Announced the publication of its New Zealand OxC-betaTM Livestock dairy trial for use against sub-clinical mastitis in the New Zealand Veterinary Journal, and its upcoming publication of research highlighting the benefits of OxC-betaTM Livestock for Broiler Poultry in Poultry Science.

Since the end of the quarter Avivagen also announced it had:
• Secured a new customer win in Western Mexico.
• Terminated its previous exclusive U.S. sales and distribution agreement and initiated discussions with potential partners to ramp up sales efforts in the lucrative region.
• Recorded its first order from Brazil, received on May 28, 2021.
• Secured first order with major swine and poultry producer in Thailand following numerous trials.

Second Quarter April 30, 2021, Financial Results
The Company’s unaudited Financial Statements for the second quarter ended April 30, 2021 and the accompanying Management’s Discussion and Analysis have been filed on the System for Electronic Document Analysis and Retrieval and are available via its website (www.sedar.com). The financial information for the second quarter ended April 30, 2021, should be read in conjunction with the Company’s unaudited Financial Statements as well as its Management’s Discussion and Analysis for the second quarter ended April 30, 2021.

The Company reported revenues of $159,614 ($29,625 in the quarter ending April 30, 2020) and a comprehensive loss of $(2,197,649) for the quarter ending April 30, 2021. This compares to a comprehensive loss in the quarter ending April 30, 2020 of $(1,393,497).

As reported in the statements of cash flows, the April 30, 2021 quarter comprehensive loss of $(2,197,649) consists of $1,181,373 in non-cashflow items such as share-based payment expense, depreciation, and adjustments to the Company’s ACOA loans. The Company reported $724,505 in interest accretion and adjustments related to the ACOA loans as a result of an increase in management’s estimate of future revenues. As noted, this ACOA adjustment is a non-cash adjustment in the quarter ending April 30, 2021.

The ACOA loans are interest-free and repayments are calculated as 10% of the future revenues and are payable on June 30th of each year. The carrying value has been discounted using a rate of 35% based on the expected timing and amounts of future repayments of the loans. Consequently, the carrying value of the ACOA loans requires regular assessment and adjustment based on management’s estimate of future revenues, with any adjustment being recorded as finance cost on the statement of comprehensive income with an equal increase in the ACOA debt liability on the statement of financial position. In light of the recent press releases announcing future and recurring order for customers in Mexico, Philippines, and Thailand, management increased its estimate of future revenues and therefore adjusted the carrying value of the ACOA loans accordingly.

The Company’s working capital increased by $949,353 as management invested in additional volumes of inventory to support future sales and increased prepaids expenses and trade receivables.

As at April 30, 2021, the Company reported total assets of $5,985,104 (current assets of $5,675,117), total liabilities of $7,163,307, and shareholders’ deficit of ($1,178,203).

Significant financing inflows during the quarter ending April 30, 2021, was an offering of 15,000,000 units of the Company at $0.50 per unit for aggregate gross proceeds of $7,500,000. The offering closed on February 16th, 2021.

Each unit consisted of one common share in the capital of the Company (each a “Common Share”) and one half of one Common Share purchase warrant (each whole warrant, a “Warrant”). Each Warrant will be exercisable to acquire one Common Share until February 16, 2024 at an exercise price of $0.75 per share. The net proceeds of the Offering have been and will be used to fund research and development expenses, sales and marketing costs, product registration, interest expense, working capital and general corporate purposes.

About Avivagen
Avivagen is a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications that, by safely supporting immune function, promote general health and performance. It is a public corporation traded on the TSX Venture Exchange under the symbol VIV and is headquartered in Ottawa, Canada, based in partnership facilities of the National Research Council of Canada. For more information, visit www.avivagen.com. The contents of the website are expressly not incorporated by reference in this press release.

About OxC-beta™ Technology and OxC-beta™ Livestock
Avivagen’s OxC-beta™ technology is derived from Avivagen discoveries about ?-carotene and other carotenoids, compounds that give certain fruits and vegetables their bright colours. Through support of immune function the technology provides a non-antibiotic means of promoting health and growth. OxC-beta™ Livestock is a proprietary product shown to be an effective and economic alternative to the antibiotics commonly added to livestock feeds. The product is currently available for sale in the United States, Philippines, Mexico, Taiwan, New Zealand, Thailand, Brazil, Australia, and Malaysia.

Avivagen’s OxC-beta™ Livestock product is safe, effective and could fulfill the global mandate to remove all in-feed antibiotics as growth promoters. Numerous international livestock trials with poultry and swine using OxC-beta™ Livestock have proven that the product performs as well as, and, sometimes, in some aspects, better than in-feed antibiotics.

Forward Looking Statements
This news release includes certain forward-looking statements that are based upon the current expectations of management. Forward-looking statements involve risks and uncertainties associated with the business of Avivagen Inc. and the environment in which the business operates. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking, including those identified by the expressions “aim”, “anticipate”, “appear”, “believe”, “consider”, “could”, “estimate”, “expect”, “if”, “intend”, “goal”, “hope”, “likely”, “may”, “plan”, “possibly”, “potentially”, “pursue”, “seem”, “should”, “whether”, “will”, “would” and similar expressions. Statements set out in this news release relating to Avivagen’s expectations as to future growth and results, the anticipated continuation of shipments to customers based on recurring orders, future plans for sales in the United States, the planned use of proceeds of the financing discussed above, Avivagen’s expectations as to growth in demand for Avivagen’s products, the possibility for OxC-beta™ Livestock to replace antibiotics in livestock feeds as well as fill a critical need for health support in certain livestock applications where antibiotics are precluded and the size of market opportunities are all forward-looking statements. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results or events to differ materially from current expectations. For instance, initial orders may not result in new orders for Avivagen’s products, despite receipt of the purchase order timing, delivery or fulfilment of orders of product could be delayed for a number of reasons, some of which are outside of Avivagen’ s control, which could result in anticipated revenues from such sales being delayed or in the most serious cases eliminated, actions taken by Avivagen’ s customers and factors affecting the business and financial viability of Avivagen’ s customers can have a negative impact on the expectation of future sales and revenues, customer plans may change due to many reasons, demand for Avivagen’s products may not continue to grow and could decline, Avivagen’s products may not gain market acceptance or regulatory approval in new jurisdictions or for new applications and may not be widely accepted as a replacement for antibiotics in livestock feeds, in each case due to many factors, many of which are outside of Avivagen’s control. Readers are referred to the risk factors associated with the business of Avivagen set out in Avivagen’s most recent management’s discussion and analysis of financial condition available at www.SEDAR.com. Except as required by law, Avivagen assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those reflected in the forward-looking statements.

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.

For more information:
Avivagen Inc.
Drew Basek
Director of Investor Relations
100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6 Phone: 416-540-0733
E-mail: d.basek@avivagen.com

Kym Anthony
Chief Executive Officer
100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6 Head Office Phone: 613-949-8164
Website: www.avivagen.com
Copyright © 2021 Avivagen Inc. OxC-beta™ is a trademark of Avivagen Inc.

electroCore Announces Publication of Study on Non-Invasive Vagus Nerve Stimulation (nVNS) to Improve Clinical Outcomes and Molecular Biomarkers in Parkinson’s Disease Patients

 

ROCKAWAY, N.J., 
June 02, 2021 (GLOBE NEWSWIRE) — 
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced the publication of a peer-reviewed paper, entitled “Non-Invasive Vagus Nerve Stimulation Improves Clinical and Molecular Biomarkers of Parkinson’s Disease in Patients with Freezing of Gait” in the journal NPJ Parkinson’s Disease. The paper reports the results of a randomized, double-blind, sham-controlled crossover trial conducted at the 
Institute of Neurosciences in 
Kolkata, India in collaboration with the Faculty of Medical Sciences at 
Newcastle University in 
England using gammaCore Sapphire^TM. The study was funded by the 
Institute of Neurosciences, 
Kolkata, India.

Neurological disorders are now the leading source of disability in the world, and Parkinson’s disease is the fastest-growing of these disorders. As populations age and life expectancy increases, the number of individuals with Parkinson’s disease and the duration of the disease will increase, leading to more patients with advanced Parkinson’s disease. To address this burden, primary prevention strategies based on the underlying causes of Parkinson’s disease and more effective symptomatic treatments are needed.¹ There are over 1 million individuals diagnosed with Parkinson’s disease in 
the United States with an estimated total annual economic burden of 
$51.9 billion.²

The study, which enrolled thirty-six subjects, was undertaken to explore the safety, feasibility and efficacy of self-administered non-invasive vagus nerve stimulation (nVNS) in the treatment of gait and other motor symptoms in Parkinson’s disease (PD) patients. In a subgroup of study patients, levels of selected neurotrophins, markers of inflammation and oxidative stress were measured in blood before and after nVNS.

Vagus Nerve Stimulation (VNS) has been found to be beneficial in improving locomotion in a rat model of PD,³ and two independent preliminary studies found improvement in gait in patients with PD after a single application of cervical nVNS.^4,5

The study provides preliminary evidence supporting the safety and efficacy of nVNS in treating motor and non-motor symptoms of PD. Patients were satisfied with the treatment and the majority were able to self-administer nVNS. Adverse events were infrequent, non-serious, and similar across both Active and Sham groups. Significant increases in velocity (p=0.003), step length (p=0.007), and a reduction in stance time (p=0.001) were seen in the nVNS treated group compared to sham stimulation, indicating that PD patients were walking not only with a faster pace but also with improved rhythm. Other gait parameters also showed significant improvement from baseline in all five domains, specifically after nVNS treatment, suggesting that nVNS may result in an overall improvement in the quality of gait in PD patients. Treatment with nVNS significantly reduced TNF-? levels (p<0.05) and increased concentrations of reduced glutathione (p<0.05), which are both markers of inflammation in PD patients. Brain Derived Neurotrophic Growth Factors, which are reduced in PD, were significantly increased by nVNS (p<0.05) suggesting a possible disease modifying effect.

Dr.  Hrishikesh Kumar, Director of Research and Vice Chairman of the 
Institute of Neurosciences Kolkata and lead investigator of the study, commented, “We are pleased to have successfully completed the first randomized, double-blind sham-controlled trial to demonstrate the efficacy of cervical nVNS as an adjunctive therapy in PD. Improvements in motor function and gait after one month of treatment with nVNS were significant. Our results clearly support additional work to further understand the potential for nVNS in this indication.”

“We congratulate and thank  Dr. Kumar,  Dr. Baker and the clinical and research teams in 
Kolkata, India and 
Newcastle, England, as well as the patients and families that participated in this study,” commented  Eric Liebler, Senior Vice President of Neurology at electroCore. “Parkinson’s disease is the fastest growing neurodegenerative disease in 
the United States. The impact of PD on patients and their families is devastating and the cost to the healthcare system is staggering. electroCore is looking forward to continuing research to bring nVNS to patients with PD.”

The full publication is available at: https://www.nature.com/articles/s41531-021-00190-x

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 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 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 gammaCore in particular to treat Parkinson’s disease or patients with freezing of gait and related disorders 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.

¹ GBD 2016 Parkinson’s Disease Collaborators. Global, regional, and national burden of Parkinson’s disease, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2018 Nov;17(11):939-953.

² Yang W, Hamilton JL, Kopil C, Beck JC, Tanner CM, Albin RL,  Ray Dorsey E, Dahodwala N, Cintina I, Hogan P,  Thompson T. Current and projected future economic burden of Parkinson’s disease in the 
U.S. NPJ Parkinsons Dis. 2020 
Jul 9;6:15.

³ Farrand, A. Q. et al. Vagus nerve stimulation improves locomotion and neuronal populations in a model of
Parkinson’s disease. Brain stimulation 10, 1045-1054 (2017).
⁴ Mondal, B. et al. Analysis of gait in Parkinson’s disease reflecting the effect of l-DOPA. Annals of
Movement Disorders 2, 21 (2019).
⁵ Morris, R. et al. Noninvasive vagus nerve stimulation to target gait impairment in Parkinson’s disease.
Movement Disorders (2019).

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

-or-

Media Contact:
Summer Diaz
electroCore
973-290-0097
summer.diaz@electrocore.com

Stem Cell Science and The New Age of Therapeutic Discovery

 

Recent advances in stem cell technologies, armed with the ability to generate almost any tissue-specific cell types of the body in a dish, human pluripotent stem cells (hPSCs) have drastically moved therapeutic research forward in unprecedented ways. Stem cell-derived cells are increasingly recognized for their potential in cell replacement therapy – that is the replacement of dying or damaged tissues in the treatment of chronic diseases and injuries, but stem cells are also playing important roles in driving drug discovery, screening, research, and development efficiently and cost-effectively [1].

 

Advantages Over Traditional Methods

Traditional methods of drug development involve pre-clinical trials on animals, primary cells, or even transformed cell lines. However, there are limitations to such methods. Firstly, animal physiology differs from that of humans, therefore disease manifestations [2], as well as responses towards compounds and drugs, may vary from humans [3]. Results from animal studies rarely correlate with human clinical trials [4]. In addition, animal research is very costly and highly variable [5]. Next, primary cells (either isolated from living or cadaveric donors) are finite in numbers; only a limited number of tests can be performed on these cells. Lastly, transformed cell lines are genetically manipulated so that they remain proliferative in order to obtain large quantities of material for drug screening and testing. However, these cells do not accurately represent native cells present in patients.

Because hPSCs are highly proliferative and capable of self-renewal, they can be easily expanded, providing an essentially unlimited source of cells. At present, it is estimated that we can generate more than 200 cell types from hPSCs [5]. This translates into the ability to produce large quantities of any cell type from hPSCs for therapeutic research. Not only does this mean that studies can be performed on various types of cells for various diseases, testing efforts can also be scaled up and accelerated while remaining to be affordable and sustainable. In vitro toxicity tests can also be easily conducted in tandem [6].

 

 

Generating ‘Diseased’ Stem Cells

Before we can begin screening and test therapeutics, we need to produce cells or tissues from diseased hPSCs. There are a few ways this can be achieved. Firstly, the discovery of induced pluripotent stem cells (iPSCs) by Nobel Prize winner Shinya Yamanaka and colleagues in 2017 [7,8] has allowed us to generate patient-specific stem cells from any patients’ cells [9] (from blood, skin biopsies, urine, etc) by simply introducing four key transcription factors into the cells. This process is termed cellular reprogramming. Despite undergoing this process of cellular reprogramming, iPSCs and their associated iPSC-derived cells, are able to preserve the original genetic mutations (if any) and disease phenotypes, therefore faithfully mimicking human disease in vitro. Over the past decade, disease-specific iPSCs have been successful in modeling a wide range of complex human diseases [1], and are therefore poise as an attractive cellular model for pharmacological testing.

Secondly, the discovery of the CRISPR-Cas9 technology [10] has revolutionized genetic editing. CRISPR-Cas9 editing system can be employed to induce genetic mutations into either healthy human embryonic stem cells or iPSCs that are known to cause certain diseases, thereby creating ‘diseased’ stem cells. These genetically edited stem cells can then be propagated and differentiated into ‘diseased’ cells (e.g. cardiomyocytes, neurons, etc.) for therapeutic discovery and screening [11].

 

Success Stories

In 2018, Tabata et al. [12] differentiated Parkinson disease (PD) patient-iPSCs (harboring PARK2 mutations; familial PD) into dopaminergic neurons and screened the diseased neurons with an FDA-approved drug library. They discovered that a drug, a calcium channel antagonist, was able to prevent neuronal death associated with the disease.

Interestingly, researchers have recently devised a co-culture system comprising of hPSC-derived endothelial cells and hepatocytes (liver cells) to test nutraceuticals. This endothelial-hepatic platform allows for the systemic effects of drug metabolism to be included in the study, which will otherwise be excluded if only endothelial cells were tested on [13].

Most recently, a group of researchers utilized iPSCs of patients with cardiac rhythm disorder long QT syndrome 3 (LQT3) and differentiated the cells into cardiomyocytes to perform HTS for anti-arrhythmic drugs. Using the LQT3-cardiomyocytes, they were able to improve their drug design and successfully tested their drug on the diseased cardiomyocytes of diverse backgrounds [14].

 

Moving Forward

hPSCs and the advancements of stem cell research have given us the capacity to generate large volumes of healthy and diseased tissue-specific cells that are true to human physiology. This has opened doors to large-scale, high-throughput drug discovery and screening, facilitating pre-clinical drug development efforts. Unlike traditional methods, hPSC-based drug development platforms are more scalable, accurate, and cost-effective.

As the field of stem cell research progresses, we can look forward to improved iPSC reprogramming protocols that increase the efficiency of obtaining patient-specific iPSCs, as well as differentiation protocols that improve the quality of differentiated cells. Efforts are also currently channeled towards devising methods to better grow and maintain stem cell-derived cells in culture. This will permit a longer duration of therapeutic and toxicity testing without cells losing their cellular identity or molecular signatures. To address concerns related to the discrepancy between the effects of drugs in vitro and in vivo, researchers have also recently explored the use of hPSC-derived organoids to model human diseases, and then perform therapeutic testing on these three-dimensional ‘mini organs’ [15]. hPSC-derived organoids are composed of multiple cell types and can better recapitulate tissue physiology and hence, clinical features of diseases.

Therefore, stem cells have opened doors to a new age of therapeutic discovery and development that promises more treatment options in the coming years, even for rare and complex human diseases.

 

About the Author:

Nicole Pek is a stem cell biologist and enthusiastic science
communicator. She has worked on using human pluripotent stem cells to study
cellular development in multiple organ systems, to model complex human
diseases, and screen for therapeutics that could treat the diseases. Outside of
the lab, Nicole plays a pro-active role in communicating to the public through
her science blog ‘Two Cells’ and her education podcast ‘The Diploid Duo’.

Suggested Reading:

The Case for Investing in Regenerative Medicine in 2021	Cells That Can be Made from Stem Cells

Improving Mortality Rates Through Genetic Research	Preventing the Immune System from Rejecting Gene Therapy

 

About the Image:

Restoration of Dystrophin in Duchenne Muscular Dystrophy Cells with Gene Editing

This image shows the restoration of
dystrophin (stained green) in Duchenne muscular dystrophy (DMD) muscle cells derived
from human induced pluripotent stem cells. DMD is caused by mutations in the
DMD gene that affect the production of dystrophin, a protein involved in muscle
cell membrane structure. Researchers used CRISPR/Cas9 gene editing technology
to correct a mutation, resulting in dystrophin restoration. This technology
could be therapeutic in up to 60% of DMD patient mutations. Nuclei in the
muscle cells are stained blue and the contractile protein myosin is stained
red.

 Credit: Courtney Young, M.S., Melissa Spencer lab, University of California, Los Angeles.

 

References

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2. Justice MJ, Dhillon P. Using the mouse to model human disease: increasing validity and reproducibility. Dis Model
Mech 2016;9:101–3.

3. Zimmerman S. Why Drugs Tested in Mice Fail in Human Clinical Trials. Sci News 2020.

4. Van Norman GA. Limitations of Animal Studies for Predicting Toxicity in Clinical Trials: Is it Time to Rethink Our Current Approach? JACC Basic Transl Sci 2019;4:845–54.

5. Boheler KR. Stem Cell Pluripotency: A Cellular Trait that Depends on Transcription Factors, Chromatin State and a Checkpoint Deficient Cell Cycle. J Cell Physiol 2009;221:10–7.

6. Hook LA. Stem cell technology for drug discovery and development. Drug Discov Today 2012;17:336–42.

7. Takahashi K, Tanabe K, Ohnuki M et
al. Induction of pluripotent stem cells from adult human fibroblasts by defined factors. Cell 2007;131:861–72.

8. Takahashi K, Yamanaka S. Induction of pluripotent stem cells from mouse embryonic and adult fibroblast cultures by defined factors. Cell 2006;126:663–76.

9. Liu G, David BT, Trawczynski M et
al. Advances in Pluripotent Stem Cells: History, Mechanisms, Technologies, and Applications. Stem Cell Rev Rep 2020;16:3–32.

10. Ran FA, Hsu PD, Wright J et al. Genome engineering using the CRISPR-Cas9 system. Nat Protoc 2013;8:2281–308.

11. Patmanathan SN, Gnanasegaran N, Lim MN et al. CRISPR/Cas9 in Stem Cell Research: Current Application and Future Perspective. Curr Stem Cell Res Ther 2018;13:632–44.

12. Tabata Y, Imaizumi Y, Sugawara M et
al. T-type Calcium Channels Determine the Vulnerability of Dopaminergic Neurons to Mitochondrial Stress in Familial Parkinson Disease. Stem Cell Rep 2018;
11:1171–84.

13. Narmada BC, Goh YT, Li H et al. Human Stem Cell?Derived Endothelial?Hepatic Platform for Efficacy Testing of Vascular?Protective Metabolites from Nutraceuticals. Stem Cells Transl Med 2017;
6:851–63.

14. McKeithan WL, Feyen DAM, Bruyneel AAN
et al. Reengineering an Antiarrhythmic Drug Using Patient hiPSC Cardiomyocytes to Improve Therapeutic Potential and Reduce Toxicity. Cell
Stem Cell 2020;27:813-821.e6.

15. Ho BX, Pek NMQ, Soh B-S. Disease Modeling Using 3D Organoids Derived from Human Induced Pluripotent Stem Cells. Int J Mol Sci 2018;19, DOI: 10.3390/ijms19040936.

 

 

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