PDS Biotech Enrolls First Stage of Checkpoint Inhibitor Naïve Patient Arm of Phase 2 Clinical Trial in Advanced HPV-16 Positive Head and Neck Cancer

 

FLORHAM PARK, N.J., Oct. 04, 2021 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies based on the Company’s proprietary Versamune^® T-cell activating technology, today announced the completion of enrollment for the first stage of the checkpoint inhibitor naïve arm of its VERSATILE-002 Phase 2 study for the treatment of recurrent and/or metastatic human papillomavirus (HPV16)-associated head and neck cancer. 90% of HPV-associated head and neck cancers are reported to be caused by HPV16 as reported by a study published in the Journal of Clinical Medicine.

VERSATILE-002 is studying two groups of HPV16-positive head and neck cancer patients whose cancer has returned or spread. The first group has not been previously treated with a checkpoint inhibitor (CPI naïve). The second group of patients have failed multiple treatments including checkpoint inhibitor therapy (CPI refractory). As specified in the clinical trial design, objective response is measured by radiographic tumor responses according to RECIST 1.1 (tumor reduction of 30% or more). If objective response is achieved among at least four of the first 17 patients in the CPI naïve arm, this will trigger advancement to the second stage of the study arm and enrollment of the planned 54 patients in the CPI naïve arm. The trial is being conducted in collaboration with Merck & Co.

“Completion of enrollment among checkpoint inhibitor naïve patients in this first stage of our VERSATILE-002 Phase 2 study in the CPI naïve arm is an important milestone, and we would like to thank the patients for their participation in this clinical trial,” said Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. “Through their involvement, together with site Investigators and study staff, this trial will help us better understand the potential contribution that PDS0101 may have in improving the lives of patients with advanced head and neck cancer.”

Dr. Jared Weiss, Section Chief of Thoracic and Head and Neck Oncology at the University of North Carolina at Chapel Hill School of Medicine and Lineberger Comprehensive Cancer Center, is serving as the Lead Principal Investigator of VERSATILE-002. Patients interested in enrolling in this clinical study should email info@pdsbiotech.com or visit the website at http://pdsbiotech.com/VERSATILE-002 to learn more.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer immunotherapies based on the Company’s proprietary Versamune^® T-cell activating technology platform. Our Versamune^®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune^® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The company’s pipeline products address various cancers including breast, colon, lung, prostate and ovarian 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 & 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 or monitoring committees’ or other third parties’ 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, significance of milestones, 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 Biotech Enrolls First Stage of Checkpoint Inhibitor Naïve Patient Arm of Phase 2 Clinical Trial in Advanced HPV-16 Positive Head and Neck Cancer

 

FLORHAM PARK, N.J., Oct. 04, 2021 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies based on the Company’s proprietary Versamune^® T-cell activating technology, today announced the completion of enrollment for the first stage of the checkpoint inhibitor naïve arm of its VERSATILE-002 Phase 2 study for the treatment of recurrent and/or metastatic human papillomavirus (HPV16)-associated head and neck cancer. 90% of HPV-associated head and neck cancers are reported to be caused by HPV16 as reported by a study published in the Journal of Clinical Medicine.

VERSATILE-002 is studying two groups of HPV16-positive head and neck cancer patients whose cancer has returned or spread. The first group has not been previously treated with a checkpoint inhibitor (CPI naïve). The second group of patients have failed multiple treatments including checkpoint inhibitor therapy (CPI refractory). As specified in the clinical trial design, objective response is measured by radiographic tumor responses according to RECIST 1.1 (tumor reduction of 30% or more). If objective response is achieved among at least four of the first 17 patients in the CPI naïve arm, this will trigger advancement to the second stage of the study arm and enrollment of the planned 54 patients in the CPI naïve arm. The trial is being conducted in collaboration with Merck & Co.

“Completion of enrollment among checkpoint inhibitor naïve patients in this first stage of our VERSATILE-002 Phase 2 study in the CPI naïve arm is an important milestone, and we would like to thank the patients for their participation in this clinical trial,” said Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. “Through their involvement, together with site Investigators and study staff, this trial will help us better understand the potential contribution that PDS0101 may have in improving the lives of patients with advanced head and neck cancer.”

Dr. Jared Weiss, Section Chief of Thoracic and Head and Neck Oncology at the University of North Carolina at Chapel Hill School of Medicine and Lineberger Comprehensive Cancer Center, is serving as the Lead Principal Investigator of VERSATILE-002. Patients interested in enrolling in this clinical study should email info@pdsbiotech.com or visit the website at http://pdsbiotech.com/VERSATILE-002 to learn more.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company developing a growing pipeline of cancer immunotherapies based on the Company’s proprietary Versamune^® T-cell activating technology platform. Our Versamune^®-based products have demonstrated the potential to overcome the limitations of current immunotherapy by inducing in vivo, large quantities of high-quality, highly potent polyfunctional tumor specific CD4+ helper and CD8+ killer T-cells. PDS Biotech has developed multiple therapies, based on combinations of Versamune^® and disease-specific antigens, designed to train the immune system to better recognize diseased cells and effectively attack and destroy them. The company’s pipeline products address various cancers including breast, colon, lung, prostate and ovarian 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 & 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 or monitoring committees’ or other third parties’ 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, significance of milestones, 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

Avivagen to Hold Webcast to Discuss Landmark Deal with AB Vista

 

• AB Vista becomes the exclusive distribution partner for OxC-beta™ for poultry, swine, ruminants (dairy and beef) and aquaculture uses in the United States, Brazil and Thailand
• Webcast to take place Wednesday, October 6th, 2021, at 10:30 a.m. EST

Ottawa, ON /Business Wire/ October 4, 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, is pleased to announce it will be holding a webcast on Wednesday, October 6th at 10:30 A.M. EST to discuss its recent sales agreement with AB Vista that was announced on Friday, October 1, 2021.

The webcast will commence with remarks by Avivagen CEO Kym Anthony, followed by a Q & A session.  To access the live webcast, visit this link to the event. Please pre-register questions with Investor Relations ahead of time. Following the live webcast, an archived version of the call will be available on Avivagen’s website.

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 beta-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.

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.

Monday, October 04, 2021

Lineage Cell Therapeutics (LCTX)
Full OpRegen Data Presentation Details Patients Improvements

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) VAC, an allogeneic dendritic cell therapy platform for immuno-oncology and infectious disease, currently in clinical development for the treatment of non-small cell lung cancer. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

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

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

Data Presented At Medical Meeting. Lineage presented an update from its Phase 1/2a clinical trial at the Annual Scientific Meeting of the Retina Society. This was the full presentation of the data announced in mid-September. The patient data showed continued improvement and maintenance of effect from the OpRegen treatments.


Presentation Provided Longer Post-Treatment Data.  The OpRegen Phase 1/2a is an open-label trial with three cohorts of 12 patients treated to establish safety, then a fourth cohort of 12 patients to determine efficacy. The presentation had more patients followed to longer treatment assessment times than previous seen. The presentation also detailed the treatment and methods of analysis for the …

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. 

AB Vista and Avivagen Strike OxC-beta™ Supply Agreement in the United States, Brazil and Thailand

 

• Eight-year agreement expected to increase OxC-Beta™ access and adoption in the largest feed production markets worldwide
• AB Vista to become exclusive distributor for use with poultry, swine, ruminants and aquaculture in United States, Brazil and Thailand
• AB Vista and Avivagen to collaborate on development efforts

Ottawa, ON/Business Wire/ October 1, 2021/ Leading global animal nutrition technology company AB Vista and Avivagen Inc.  (TSXV:VIV, OTCQB:VIVXF) (“Avivagen”) today announced they have entered into a transformative supply agreement that is expected to expand the adoption and use of OxC-beta™ in a number of high-value feed production markets worldwide. The landmark eight-year deal will see AB Vista become the exclusive distribution partner for OxC-beta™ for poultry, swine, ruminants (dairy and beef) and aquaculture uses in the United States, Brazil and Thailand.

AB Vista is a global animal nutrition technology company supplying feed additives, nutrition expertise and analytical services to animal feed and protein producers.

“This is a truly transformative partnership for Avivagen, and one that stands to benefit not only us and AB Vista but feed and livestock producers in the Americas and Asia as well,” says Kym Anthony, Chief Executive Officer, Avivagen Inc. “We’ve had a lot of interest from potential partners for OxC-beta™, but AB Vista’s expertise and track record set it apart. With their industry-leading technical knowledge and know-how we are confident that this agreement will drive considerable adoption of OxC-beta™ and growth for Avivagen over the better part of the next decade.”

As a part of the agreement AB Vista and Avivagen will also collaborate on future development efforts, including advancing opportunities for OxC-beta™ use for aquaculture purposes (such as shrimp production). Aquaculture represents a new category for OxC-beta™ use, following considerable success with poultry, swine and ruminants in markets worldwide.

“We pride ourselves on bringing pioneering, high-value products and services to  the global animal feed market. We believe OxC-beta™ could be one of the next great innovations and advancements in animal nutrition, and we’re excited to be able to deliver this great product to our customers,” says Juan Ignacio Fernandez, Managing Director, AB Vista.

“Based on the extensive technical data supporting the role OxC-beta™ can have in reducing production reliance on antibiotics, we are confident our customers in the United States, Brazil and Thailand will have high demand for such a differentiated product.”

The United States and Brazil represent the world’s second and third largest feed production markets, accounting for nearly 300 million metric tonnes of feed produced in 2020[1]. More than one-quarter of 2021 international feed tonnage was produced in these two markets alone.

About AB Vista
AB Vista is a global feed additive business bringing pioneering products and technical services to the poultry, swine, ruminant and aquaculture sectors. Since its launch in 2005 the company has become a highly respected global player with top three market share positions in its core segments. The business uses its innovative product research, technical services and nutrition expertise to gather global insights that can be used to provide new ways of thinking to feed compounders, integrators and pre-mixers. With over 25 years’ experience in the NIR field and a global network of laboratories able to analyse feed samples, AB Vista provides the tools and expertise to allow its customer to better balance their ingredients. AB Vista is headquartered in the UK, with regional offices located in the USA, Brazil, Singapore, Spain, India, China, Germany and Finland.

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 the term of the agreement with AB Vista, expections as to expansion and adoption of products, Avivagen’s expectations as to future growth and results, the anticipated benefits of this agreement to Avivagen and others, future collaboration, future product development, 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, the supply agreement could be terminated prior to 8 years for a number of reasons, Avivagen’s products may not be adopted at the rate anticipated, Avivagen may not benefit from the supply agreement as anticipated, future collaboration and product development may not occur or may not be successful in developing viable products, 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

AB Vista – a division of AB Agri Ltd
Lynsey Wickens
3 Woodstock Court, Blenheim Road, Marlborough Business Park,
Marlborough, Wiltshire, SN8 4AN
t +44 (0)1672 517662

e-mail: lynsey.wickens@abvista.com

[1] 2021 Alltech Global Feed Survey: https://www.petfoodindustry.com/articles/9973-th-annual-alltech-global-feed-survey-estimates-world-feed-production-increased-1

Pain Management Market to Grow to $81.9 Billion by 2026

 

“No pain, no gain” is a motivational gym saying heard for years. Investors have found the saying also applies to portfolio gains.  The pain management industry is rapidly growing and now provides an even broader spectrum of publicly traded opportunities. Why? Reduced opioid use has opened a path for inventive new therapeutics to become the new go-to where an opioid would have been prescribed previously.  Estimates on the potential for the industry were just released in a report by Zion Market Research. The report demonstrates the pain management therapeutics industry is expected to amass earnings of about $81.9 billion by 2026. This is an increase of $16.3 billion over 2019 earnings.

Background:

Treatment of chronic pain has a large base as a major healthcare service. This base provides a solid footing for the business of pain management therapeutics.  Pain-relieving drugs such as opioids have provided help to patients with severe pain, but their usage should be short-term in duration or to treat pain in the terminally ill. New protocols based on this reality leave many sufferers that had relied on addictive pharmaceuticals needing new alternatives.

Primary pharmaceutical segments in Pain Management:

• Anesthetics
• NSAIDS
• Anticonvulsants
• Antidepressants
• Anti-migraine agents
• Non-narcotic analgesics

Major uses for which they are indicated include: 

• Neuropathic Pain
• Arthritic Pain
• Cancer pain
• Post-operative Pain
• Chronic Back Pain
• Fibromyalgia
• A migraine

Market
Growth Dynamics

As the number of patients affected with chronic pain increases among an aging population, and opioid prescriptions come under more scrutiny, medical treatments, including non-pharmacologic therapies, and interventional pain treatments, have increased. The pain management therapeutics market is expected to continue its accelerated growth over the next couple of years. This is expected to translate into a $16.3 billion expansion of industry earnings over the next few years, according to the Zion report.  Additionally, they expect, growth in the number of surgeries along with an increase in automotive accidents and sports injuries. This will also serve to lift this market involved in helping sufferers.

Expansion
Prospects

The anticipated growth of pain management therapeutics within North American healthcare is expected to happen on several fronts. Players include the nimble, creative growth companies as well as the huge established names. Large companies involved in the segment include Novartis AG, Purdue Pharma L.P., AstraZeneca Plc., Mallinckrodt Pharmaceuticals, GlaxoSmithKline Plc., Teva Pharmaceutical Industries Ltd., Pfizer Inc., Depomed, Inc., Johnson & Johnson Services, Inc., Endo International Plc., Merck & Co., Inc., and Abbott Laboratories. These are big corporations where successful individual products aren’t as impactful to the bottom line or stock price movement.

The smaller more nimble prospects are worth learning about. There are a number of them that have developed solutions that are just now becoming adopted and substituted for old methods of treatment. Below is a list of six companies in this space that may be worth becoming familiar with:

NanoVibronix
Inc. (NAOV)  is engaged in manufacturing of noninvasive biological response-activating devices which target wound healing and pain therapy, without the assistance of medical professionals. The primary products of the company include WoundShield which is patch-based therapeutic ultrasound device to help regenerate tissue and healing by using ultrasound to increase local capillary perfusion and tissue oxygenation; PainShield which is a disposable patch-based therapeutic ultrasound technology to treat pain, muscle spasm and joint contractures; and UroShield which is an ultrasound-based product designed to prevent bacterial colonization and biofilm in urinary catheters, increase antibiotic efficacy and decrease pain. Most of the company’s revenue comes from the U.S. $NAOV is listed on the Nasdaq exchange.

Bioelectronics Corp. (BIEL) is an electroceutical company. It develops wearable, neuromodulation devices to safely mitigate neurological diseases. Its product line includes Actipatch Musculoskeletal Pain Therapy, Allay menstrual pain therapy, Smart insole heel pain therapy and Recovery RX post-operative and Chronic wounds therapy. The company sells its products to wholesale distributors, directly to hospitals and clinics, and consumers. $BIEL trades OTC.

 

 

Baudax Bio Inc.
(BXRX) is a Pharmaceutical company. The company develops and commercialize products for hospital and related acute care settings. Products in its pipeline include two novel neuromuscular blocking agents, or NMBAs, and a related proprietary chemical reversal agent and Dex-IN. $BXRX is listed on the Nasdaq exchange.

Virpax
Pharmaceuticals Inc. (VRPX) is a preclinical stage biopharmaceutical company. The company is focused on developing pharmaceutical product candidates for pain management. Its product portfolio includes Topical metered-dose spray, Liposomal in Hydrogel encapsulation, and Enkephalin Intranasal spray. $VRPX is listed on the Nasdaq exchange.

Heron
Therapeutics Inc. (HRTX) is a commercial-stage biotechnology company. It’s focused on improving the lives of patients by developing treatments that address some of the unmet patient needs. The company’s product portfolio consists of SUSTOL and CINVANTI. Its pipeline product is HTX-011. $HRTX is listed on the Nasdaq exchange.

Medx Health
Corp. (MDXHF) is engaged in the development, manufacturing, and marketing of skin-related screening tools and phototherapy devices for pain relief and tissue repair. Its two main product lines are; SIAscopy, a medical device technology that is used to scan skin for suspicious moles and lesions; and Phototherapeutic medical devices, which use light energy in lower-level laser and LED to provide effective treatment of pain and tissue damage in the rehabilitation market. It derives key revenue from the sale of Phototherapeutic lasers. Its product portfolio includes SIAscopy, MoleMate, SIMSYS, MedX Home System, Rehab Portable Laser, Debtal Laser Console System and others. The company sells its products internationally, of which prime revenue is generated in Canada and the US. $MDXHF trades OTC.

Take-Away

Heightened awareness of the risks associated with prescribing opioids coupled with an aging populous is providing opportunities for companies to develop new methods to minimize suffering; this includes medical devices to treat or assess causes, and novel medicines. Investors could benefit from growing their awareness of this therapeutic space and individual companies operating in the pain management sector.

There is usually no better way to understand a company than letting management explain the products and their uses. A virtual conference with management from the above six companies will take place on October 6. There is no cost to register or attend some or all of the sessions.

Suggested Content:

Helius Medical Technologies Inc. – Roadshow Video Replay

Lineage Cell Therapeutics, Inc. – C-Suite Interview (Video)

Ayala Pharmaceuticals (AYLA) NobleCon17 Presentation Replay

Cocrystal Pharma (COCP) NobleCon17 Presentation Replay

 Sources:

https://www.zionmarketresearch.com/news/pain-management-therapeutics-market

https://channelchek.vercel.app/news-channel/New_Developments_in_Pain_Management___a_NobleCon_Online_Investor_Event___Presenting_Companies

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AB Vista and Avivagen Strike OxC-beta™ Supply Agreement in the United States, Brazil and Thailand

 

• Eight-year agreement expected to increase OxC-Beta™ access and adoption in the largest feed production markets worldwide
• AB Vista to become exclusive distributor for use with poultry, swine, ruminants and aquaculture in United States, Brazil and Thailand
• AB Vista and Avivagen to collaborate on development efforts

Ottawa, ON/Business Wire/ October 1, 2021/ Leading global animal nutrition technology company AB Vista and Avivagen Inc.  (TSXV:VIV, OTCQB:VIVXF) (“Avivagen”) today announced they have entered into a transformative supply agreement that is expected to expand the adoption and use of OxC-beta™ in a number of high-value feed production markets worldwide. The landmark eight-year deal will see AB Vista become the exclusive distribution partner for OxC-beta™ for poultry, swine, ruminants (dairy and beef) and aquaculture uses in the United States, Brazil and Thailand.

AB Vista is a global animal nutrition technology company supplying feed additives, nutrition expertise and analytical services to animal feed and protein producers.

“This is a truly transformative partnership for Avivagen, and one that stands to benefit not only us and AB Vista but feed and livestock producers in the Americas and Asia as well,” says Kym Anthony, Chief Executive Officer, Avivagen Inc. “We’ve had a lot of interest from potential partners for OxC-beta™, but AB Vista’s expertise and track record set it apart. With their industry-leading technical knowledge and know-how we are confident that this agreement will drive considerable adoption of OxC-beta™ and growth for Avivagen over the better part of the next decade.”

As a part of the agreement AB Vista and Avivagen will also collaborate on future development efforts, including advancing opportunities for OxC-beta™ use for aquaculture purposes (such as shrimp production). Aquaculture represents a new category for OxC-beta™ use, following considerable success with poultry, swine and ruminants in markets worldwide.

“We pride ourselves on bringing pioneering, high-value products and services to  the global animal feed market. We believe OxC-beta™ could be one of the next great innovations and advancements in animal nutrition, and we’re excited to be able to deliver this great product to our customers,” says Juan Ignacio Fernandez, Managing Director, AB Vista.

“Based on the extensive technical data supporting the role OxC-beta™ can have in reducing production reliance on antibiotics, we are confident our customers in the United States, Brazil and Thailand will have high demand for such a differentiated product.”

The United States and Brazil represent the world’s second and third largest feed production markets, accounting for nearly 300 million metric tonnes of feed produced in 2020[1]. More than one-quarter of 2021 international feed tonnage was produced in these two markets alone.

About AB Vista
AB Vista is a global feed additive business bringing pioneering products and technical services to the poultry, swine, ruminant and aquaculture sectors. Since its launch in 2005 the company has become a highly respected global player with top three market share positions in its core segments. The business uses its innovative product research, technical services and nutrition expertise to gather global insights that can be used to provide new ways of thinking to feed compounders, integrators and pre-mixers. With over 25 years’ experience in the NIR field and a global network of laboratories able to analyse feed samples, AB Vista provides the tools and expertise to allow its customer to better balance their ingredients. AB Vista is headquartered in the UK, with regional offices located in the USA, Brazil, Singapore, Spain, India, China, Germany and Finland.

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 the term of the agreement with AB Vista, expections as to expansion and adoption of products, Avivagen’s expectations as to future growth and results, the anticipated benefits of this agreement to Avivagen and others, future collaboration, future product development, 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, the supply agreement could be terminated prior to 8 years for a number of reasons, Avivagen’s products may not be adopted at the rate anticipated, Avivagen may not benefit from the supply agreement as anticipated, future collaboration and product development may not occur or may not be successful in developing viable products, 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

AB Vista – a division of AB Agri Ltd
Lynsey Wickens
3 Woodstock Court, Blenheim Road, Marlborough Business Park,
Marlborough, Wiltshire, SN8 4AN
t +44 (0)1672 517662

e-mail: lynsey.wickens@abvista.com

[1] 2021 Alltech Global Feed Survey: https://www.petfoodindustry.com/articles/9973-th-annual-alltech-global-feed-survey-estimates-world-feed-production-increased-1

Thursday, September 30, 2021

Avivagen Inc. (VIVXF)(VIV:CA)
Reports 3Q21 Results; Pipeline Remains Strong

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.

3Q21 Results. Avivagen reported revenue of $505,866 in the quarter, down from $612,530 last year. We had estimated revenue of $1.0 million. The majority of the miss comes from a 3.5 million tonne order shipped in the quarter for which the revenue has yet to be recognized. We estimate the delayed revenue to be in the $375,000 range. Net loss for the quarter was $1.5 million, or $0.03 per share versus a net loss of $787,424, or $0.02 per share, in 3Q20. We had forecast a net loss of $1.1 million, or $0.02 per share.


Pipeline.  The pipeline continues to expand, with management calling it “the strongest pipeline in Avivagen history. During the quarter, the Company secured a new customer win in Western Mexico, recorded its first order from Brazil and secured the first order with a major swine and poultry producer in Thailand. We expect OxC-beta to further penetrate the livestock feed market …

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. 

Promising New Opregen® Clinical Data Featured At 54th Annual Retina Society Meeting In Podium Presentation By Christopher D. Riemann, M.D.

 

Statistically Significant Evidence of a Treatment Effect with OpRegen Observed in Cohort 4 Patients

CARLSBAD, Calif.–(BUSINESS WIRE)–Sep. 30, 2021– 

Lineage Cell Therapeutics, Inc.
 (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, reported today that updated interim results from a Phase 1/2a clinical study of its lead product candidate, OpRegen^®, an investigational retinal pigment epithelium cell transplant therapy currently in development for the treatment of dry age-related macular degeneration (AMD), were featured in a podium presentation at the 54th Annual Scientific Meeting of the Retina Society. The presentation, “Phase 1/2a Clinical Trial of Transplanted Allogeneic Retinal Pigmented Epithelium (RPE, OpRegen) Cells in Advanced Dry Age-Related Macular Degeneration (AMD): Interim Results,” was presented by 
Christopher D. Riemann , M.D., Vitreoretinal Surgeon and Fellowship Director, 

Cincinnati Eye Institute
 (CEI) and 
University of Cincinnati School of Medicine.

Patients enrolled into the clinical study all had bilateral, advanced, atrophic AMD. OpRegen was transplanted into the subretinal space, near or across the area of geographic atrophy (GA) of their worse seeing eyes, and the patients were routinely followed as scheduled per protocol. Data presented today showed that as patients continued to progress into post-operative follow-up, eyes receiving OpRegen trended toward improvement in visual acuity, a secondary objective under the study, while their untreated eyes typically lost visual acuity, as expected with this progressive disease. As additional patients have reached longer periods post-treatment, differences in visual acuity between treated and untreated eyes across Cohort 4 patients became statistically significant beginning at month 9 (P = 0.0085), as well as months 12 (P = 0.0220) and 15 (P = 0.0273) as determined via 2-sided Wilcoxon Signed Rank (using 
NCSS, LLC statistical software). These results, when combined with the previously reported data from detailed analyses of multimodal imaging, including optical coherence tomography (OCT), which showed evidence of retinal restoration in areas previously considered to be atrophic, suggest that both a structural and functional benefit is possible with OpRegen therapy. Additionally, OpRegen continues to be well tolerated and there have been no new, unexpected ocular or systemic adverse events or serious adverse events.

“This is an exciting time for the OpRegen program, the participating investigative sites, and for patients suffering from dry AMD. The efficacy findings presented today are both statistically significant as well as clinically important,” stated  Christopher D. Riemann, M.D. “Prior clinical data readouts were mostly descriptive and lacked enough patients and post-treatment follow-up to allow for detailed statistical analyses. A significant number of better vision Cohort 4 patients are now 9, 12, and even 15 months post-treatment with OpRegen. As a result, we were able to analyze the available results to ascertain if a detectable efficacy signal could be observed in a relatively small number of patients. Though this early phase trial is open label, non-randomized and not placebo controlled, the significant differences in visual acuity of patients’ OpRegen treated eyes compared to their fellow, untreated eyes over time is very important. Though larger, controlled studies are needed, OpRegen is a potentially transformational therapy for these patients without any approved treatment options. These results strongly support further late-stage development, and we are eager to begin those studies.”

“As more patients in the OpRegen trial reach clinically relevant observation periods, our data set grows larger and permits us to conduct additional analyses like the one reported today. These new data support our view that our cell transplant approach can deliver not only anatomical changes detectable by imaging studies, but also durable functional benefits to visual acuity,” stated  Brian M. Culley, Lineage CEO. “OpRegen already is well-positioned among product candidates in development for dry AMD as the only one that has demonstrated an ability to halt or reverse the expansion of geographic atrophy and we are additionally reporting statistically significant differences in visual acuity over time between treated and untreated eyes in our intended patient population. We are excited to continue developing OpRegen as a potential treatment for dry AMD with GA.”

Dr. Riemann’s presentation will be available on the Events and Presentations section of Lineage’s website.

The 
Retina Society was founded in 1968 exclusively for educational and scientific purposes concerning the diagnosis, care and treatment of diseases and injuries to the retina. For more information on the 
Retina Society or its annual scientific meeting, please visit https://www.retinasociety.org/ or follow the association on Twitter @RetinaSociety.

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 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 has been well tolerated to date and there have been no new, unexpected ocular or systemic adverse events or serious adverse events that have not been previously reported. 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 (FDA), 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.

Forward-Looking Statements

Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “can,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “tend to,” or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to the potential benefits of treatment with OpRegen in dry AMD patients with GA, the significance of clinical data reported to date from the ongoing Phase 1/2a study of OpRegen, including the findings of retinal tissue restoration, Lineage’s plans to meet with the FDA to discuss OpRegen’s clinical development, the potential utilization of OCT imaging to measure efficacy in a pivotal clinical trial of OpRegen for the treatment of dry AMD with GA, and the potential for Lineage’s investigational allogeneic cell therapies to provide safe and effective treatment for multiple, diverse serious or life threatening conditions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineage’s business and other risks in Lineage’s filings with the 
Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the 
SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the 
SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

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

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

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

Source: 
Lineage Cell Therapeutics, Inc.

New Developments in Pain Management – a NobleCon Online Investor Event
October 7, 2021

More than 100 million Americans have acute and chronic pain issues. Migraines and headaches, osteoarthritis, fibromyalgia, nerve pain, back pain, post-surgical pain, and cancer. Chronic pain in many circles is considered a disease of its own. Opioid painkillers, while highly effective, have increased the risk of abuse, addiction, and death; in the U.S. alone, in 2020, 93,000 deaths were attributed to opioids.

The global pain management market is estimated at over $65 billion (2020). Given the need and vastness of the market, the companies presenting are developing new therapies and interventions to improve the health and well-being of lives by effectively treating various forms of pain, while reducing the potential for abuse and addiction. Join us on October 7, 2021 for a day of innovation, revelation and opportunity.

The event is free and open to all registered users of Channelchek. Registration is fast and free. Not already a member? Use the link below to register now so you’re ready to view the Summit presentations on August 31.

Event Page – View the Presentations Here

Register for Channechek to gain access to the Investor Event

Click the logos for more information on the presenting companies

Baudax Bio (BXRX)	BioElectronics Corporation (BIEL)
electroCore (ECOR)	Heron Therapeutics (HRTX)
MedX Health (MDXHF)	Virpax Pharmaceuticals (VRPX)

Promising New Opregen® Clinical Data Featured At 54th Annual Retina Society Meeting In Podium Presentation By Christopher D. Riemann, M.D.

 

Statistically Significant Evidence of a Treatment Effect with OpRegen Observed in Cohort 4 Patients

CARLSBAD, Calif.–(BUSINESS WIRE)–Sep. 30, 2021– 

Lineage Cell Therapeutics, Inc.
 (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, reported today that updated interim results from a Phase 1/2a clinical study of its lead product candidate, OpRegen^®, an investigational retinal pigment epithelium cell transplant therapy currently in development for the treatment of dry age-related macular degeneration (AMD), were featured in a podium presentation at the 54th Annual Scientific Meeting of the Retina Society. The presentation, “Phase 1/2a Clinical Trial of Transplanted Allogeneic Retinal Pigmented Epithelium (RPE, OpRegen) Cells in Advanced Dry Age-Related Macular Degeneration (AMD): Interim Results,” was presented by 
Christopher D. Riemann , M.D., Vitreoretinal Surgeon and Fellowship Director, 

Cincinnati Eye Institute
 (CEI) and 
University of Cincinnati School of Medicine.

Patients enrolled into the clinical study all had bilateral, advanced, atrophic AMD. OpRegen was transplanted into the subretinal space, near or across the area of geographic atrophy (GA) of their worse seeing eyes, and the patients were routinely followed as scheduled per protocol. Data presented today showed that as patients continued to progress into post-operative follow-up, eyes receiving OpRegen trended toward improvement in visual acuity, a secondary objective under the study, while their untreated eyes typically lost visual acuity, as expected with this progressive disease. As additional patients have reached longer periods post-treatment, differences in visual acuity between treated and untreated eyes across Cohort 4 patients became statistically significant beginning at month 9 (P = 0.0085), as well as months 12 (P = 0.0220) and 15 (P = 0.0273) as determined via 2-sided Wilcoxon Signed Rank (using 
NCSS, LLC statistical software). These results, when combined with the previously reported data from detailed analyses of multimodal imaging, including optical coherence tomography (OCT), which showed evidence of retinal restoration in areas previously considered to be atrophic, suggest that both a structural and functional benefit is possible with OpRegen therapy. Additionally, OpRegen continues to be well tolerated and there have been no new, unexpected ocular or systemic adverse events or serious adverse events.

“This is an exciting time for the OpRegen program, the participating investigative sites, and for patients suffering from dry AMD. The efficacy findings presented today are both statistically significant as well as clinically important,” stated  Christopher D. Riemann, M.D. “Prior clinical data readouts were mostly descriptive and lacked enough patients and post-treatment follow-up to allow for detailed statistical analyses. A significant number of better vision Cohort 4 patients are now 9, 12, and even 15 months post-treatment with OpRegen. As a result, we were able to analyze the available results to ascertain if a detectable efficacy signal could be observed in a relatively small number of patients. Though this early phase trial is open label, non-randomized and not placebo controlled, the significant differences in visual acuity of patients’ OpRegen treated eyes compared to their fellow, untreated eyes over time is very important. Though larger, controlled studies are needed, OpRegen is a potentially transformational therapy for these patients without any approved treatment options. These results strongly support further late-stage development, and we are eager to begin those studies.”

“As more patients in the OpRegen trial reach clinically relevant observation periods, our data set grows larger and permits us to conduct additional analyses like the one reported today. These new data support our view that our cell transplant approach can deliver not only anatomical changes detectable by imaging studies, but also durable functional benefits to visual acuity,” stated  Brian M. Culley, Lineage CEO. “OpRegen already is well-positioned among product candidates in development for dry AMD as the only one that has demonstrated an ability to halt or reverse the expansion of geographic atrophy and we are additionally reporting statistically significant differences in visual acuity over time between treated and untreated eyes in our intended patient population. We are excited to continue developing OpRegen as a potential treatment for dry AMD with GA.”

Dr. Riemann’s presentation will be available on the Events and Presentations section of Lineage’s website.

The 
Retina Society was founded in 1968 exclusively for educational and scientific purposes concerning the diagnosis, care and treatment of diseases and injuries to the retina. For more information on the 
Retina Society or its annual scientific meeting, please visit https://www.retinasociety.org/ or follow the association on Twitter @RetinaSociety.

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 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 has been well tolerated to date and there have been no new, unexpected ocular or systemic adverse events or serious adverse events that have not been previously reported. 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 (FDA), 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.

Forward-Looking Statements

Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “can,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “tend to,” or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to the potential benefits of treatment with OpRegen in dry AMD patients with GA, the significance of clinical data reported to date from the ongoing Phase 1/2a study of OpRegen, including the findings of retinal tissue restoration, Lineage’s plans to meet with the FDA to discuss OpRegen’s clinical development, the potential utilization of OCT imaging to measure efficacy in a pivotal clinical trial of OpRegen for the treatment of dry AMD with GA, and the potential for Lineage’s investigational allogeneic cell therapies to provide safe and effective treatment for multiple, diverse serious or life threatening conditions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineage’s business and other risks in Lineage’s filings with the 
Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the 
SEC, including Lineage’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the 
SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

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

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

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

Source: 
Lineage Cell Therapeutics, Inc.

Thursday, September 30, 2021

Avivagen Inc. (VIVXF)(VIV:CA)
Reports 3Q21 Results; Pipeline Remains Strong

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.

3Q21 Results. Avivagen reported revenue of $505,866 in the quarter, down from $612,530 last year. We had estimated revenue of $1.0 million. The majority of the miss comes from a 3.5 million tonne order shipped in the quarter for which the revenue has yet to be recognized. We estimate the delayed revenue to be in the $375,000 range. Net loss for the quarter was $1.5 million, or $0.03 per share versus a net loss of $787,424, or $0.02 per share, in 3Q20. We had forecast a net loss of $1.1 million, or $0.02 per share.


Pipeline.  The pipeline continues to expand, with management calling it “the strongest pipeline in Avivagen history. During the quarter, the Company secured a new customer win in Western Mexico, recorded its first order from Brazil and secured the first order with a major swine and poultry producer in Thailand. We expect OxC-beta to further penetrate the livestock feed market …

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 Third Quarter Ending July 31, 2021

 

• Total of 8 tonnes in orders secured or shipped during the quarter
• Quarter represents more than 43% of 2020 fiscal year

Ottawa, ON /Business Wire/ September 29, 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 third quarter of 2021.

“The considerable successes of the past quarter have resulted in arguably the strongest pipeline in Avivagen’s history,” says Kym Anthony, Chief Executive Officer, Avivagen Inc. “We have already begun to deliver on the largest sales volumes in company history, and efforts worldwide are forging high-value relationships with new partners and customers in the Americas and Asia.”

Q3 2021 highlights included:

• Total of 8 tonnes in OxC-beta™ orders secured or shipped during the quarter
  • Secured a 4.4-tonne order for OxC-beta^TM Livestock from UNAHCO
  • Secured a 500 kg order for OxC-beta^TM Livestock from Transformadora
  • Shipped 3.5-tonne order from the previously announced 64-tonne recurring order
• Moved closer to regulatory approval in Vietnam and China
• Leveraging existing experience, initiated search for new distribution partners in North America and other key markets globally

During the quarter Avivagen shipped the first 3.5 tonnes of its previously announced 64 tonne recurring order. However, the revenue on this shipment will be recognized when payment is received, meaning the revenue associated with this shipment is not reflected in the reported Q3 results.

Third Quarter: July 31, 2021, Financial Results

The Company’s unaudited Financial Statements for the third quarter ended July 31, 2021 and the accompanying Management’s Discussion and Analysis have been filed on the System for Electronic Document Analysis and Retrieval and are also available via its website (www.sedar.com).  The financial information for the third quarter ended July 31, 2021, should be read in conjunction with the Company’s unaudited Financial Statements as well as its Management’s Discussion and Analysis for the third quarter ended July 31, 2021.

The Company reported revenues of $505,886 ($612,530 in the quarter ending July 31, 2020) and a comprehensive loss of $(1,503,665) for the quarter ending July 31, 2021. This compares to a comprehensive loss in the quarter ending July 31, 2020 of $(787,424).

As at July 31, 2021, the Company reported total assets of $4,865,220 (current assets of $4,569,978), total liabilities of $7,456,993, and shareholders’ deficit of ($2,591,773).

Significant financing inflows during the nine-month ending July 31, 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 16^th, 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 pipeline, its expectations as to future growth, demand for products and results, the anticipated future value of relationships being established, the anticipated continuation of shipments to customers based on recurring orders,  the planned use of proceeds of the financing discussed above,   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