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: [email protected]

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: [email protected]

[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:

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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: [email protected]

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: [email protected]

[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
([email protected])
(442) 287-8963

Solebury Trout IR
Mike Biega
([email protected])
(617) 221-9660

Russo Partners – Media Relations
Nic Johnson or  David Schull
[email protected]
[email protected]
(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
([email protected])
(442) 287-8963

Solebury Trout IR
Mike Biega
([email protected])
(617) 221-9660

Russo Partners – Media Relations
Nic Johnson or  David Schull
[email protected]
[email protected]
(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: [email protected]

Kym Anthony
Chief Executive Officer
100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6 Head Office Phone: 613-949-8164
Website: www.avivagen.com

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: [email protected]

Kym Anthony
Chief Executive Officer
100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6 Head Office Phone: 613-949-8164
Website: www.avivagen.com

Genprex Strengthens Management Team with Appointments of Industry Leaders Mark S. Berger, M.D. as Chief Medical Officer and Hemant Kumar, Ph.D. as Chief Manufacturing and Technology Officer

 

Neovasc REDUCER-I Study Published in EuroIntervention Journal

 

VANCOUVER and MINNEAPOLIS – (NewMediaWire) – September 28, 2021 – Neovasc, Inc. (Neovasc or the Company) (NASDAQ TSX:NVCN) today announced the publication of an article entitled, Coronary sinus narrowing for the treatment of refractory angina: a multi-centre prospective open-label clinical study (the REDUCER-I study) in the September 2021 issue of the journal EuroIntervention.

The articles lead authors areStefan Verheye, MD, PhD, Cardiovascular Center, ZNA Middelheim Hospital, Antwerp, Belgium, and Maayan Konigstein, MD, from the Tel Aviv Medical Center, Tel Aviv, Israel. The publication provides interim results from the REDUCER-I study investigating patients suffering from refractory angina treated with the Neovasc Reducer(TM) (Reducer) system.The REDUCER-I study is a prospective, open-label, multi-center, international, post-market study, (with a retrospective component) which collects long-term data of patients with refractory angina treated with the Reducer. The publication outlines the overall clinical outcomes of the first 228 patients enrolled.

The primary efficacy endpoint was the percentage of patients who experience improvement in their angina symptoms defined as a reduction in Canadian Cardiovascular Society (CCS) grade, a measure of their disability, at six months as compared to baseline. The primary safety endpoints are the rate of occurrence of device- and/or procedure-related periprocedural serious adverse events, and major adverse cardiac events (MACE), a composite of cardiac death, major stroke and myocardial infarction up to 30 days post implant.

In the first 228 patients (81% male, 68.39.6 years), the procedural success rate was very high (99%), with a very high safety profile that translated to only one adjudicated possible procedural or device-related MACE. Mean CCS class improved from 2.80.6 at baseline, to 1.80.7 at two years. Improvement in 1 CCS class was observed in 82%, and in 2 CCS classes in 31% of patients at two years. At baseline, 70% of the cohort were disabled at very minimal physical effort (reported to be in CCS class III-IV); this portion was reduced to only 15% at follow-up. Additional measured parameters of functional class and quality of life were also improved.

The data published in the REDUCER-I study confirm the high safety profile of the therapy in patients suffering from refractory angina. The results also demonstrate sustained improvement in angina severity and in quality of life up to two years, said Prof. Verheye. I am encouraged that we now have a therapy to offer patients whom, in the past, had no treatment options. In properly selected patients, the Reducer offers hope for a return to a more normal life that is less hampered by the debilitating symptoms of refractory angina.

An accompanying editorial, Coronary sinus reducer therapy for refractory angina: is it ready for prime time? was published in the same issue of EuroIntervention. Authored by Dr. Michael Foley, MBBS, BSc and Dr. Rasha Al-Lamee, MBBS, MA, PhD, both from National Heart and Lung Institute, Imperial College London, United Kingdom, the editorial states, The most important additive finding of REDUCER-I is the real-world procedural success and safety of a new device. The authors further suggest that the ongoing ORBITA-COSMIC study and the upcoming COSIRA-II trial will be helpful to validate the Reducer device for an important and often overlooked clinical group.

Publication of the interim results of REDUCER-I is another meaningful step as we build the evidence necessary to establish the Reducer as standard of care for patients suffering from refractory angina, stated Fred Colen, President & Chief Executive Officer of Neovasc. We are encouraged by the peer-reviewed clinical data that continues to mount supporting Reducer therapy as a viable treatment option for patients that are suffering from angina-related chest pain. Its gratifying to see so many patients be able to return to the daily living activities that they have previously avoided.

 

About Reducer

The Reducer is CE-marked in the European Union and Under Investigation in the United States for the treatment of refractory angina, a painful and debilitating condition that occurs when the coronary arteries deliver an inadequate supply of blood to the heart muscle, despite treatment with standard revascularization or cardiac drug therapies. It affects millions of patients worldwide, who typically lead severely restricted lives as a result of their disabling symptoms, and its incidence is growing. The Reducer provides relief of angina symptoms by altering blood flow within the myocardium of the heart and increasing the perfusion of oxygenated blood to ischemic areas of the heart muscle. Placement of the Reducer is performed using a minimally invasive transvenous procedure that is similar to implanting a coronary stent and can be completed in approximately 20 minutes.

While the Reducer is not approved for commercial use in the United States, the FDA granted Breakthrough Device designation to the Reducer in October 2018.

Refractory angina, resulting in continued symptoms despite maximal medical therapy and without revascularization options, is estimated to affect 600,000 to 1.8 million Americans, with 50,000 to 100,000 new cases per year.

 

About Neovasc Inc.

Neovasc is a specialty medical device company that develops, manufactures, and markets products for the rapidly growing cardiovascular marketplace. The Company is a leader in the development of minimally invasive transcatheter mitral valve replacement technologies, and minimally invasive devices for the treatment of refractory angina. Its products include the Neovasc Reducer(TM), 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 Tiara(TM), 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
[email protected]

 

Media

SeanLeous
Westwicke/ICR
Phone: +1.646.866.4012
[email protected]

 

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, the interpretations and implications of the REDUCER-I study, the efficacy of the Reducer as a therapy for patients who suffer from refractory angina, the procedural safety and success of the Reducer, the ORBITA-COSMIC study and COSIRA-II trials helpfulness to validating the Reducer, the building of evidence necessary to establish the Reducer as standard of care for patients suffering from refractory angina, the mounting supporting of Reducer therapy as a viable treatment option for patients that are suffering from angina-related chest pain and the growing cardiovascular marketplace. Many factors and assumptions could cause the Company’s actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements, including, without limitation, the doubt about the Company’s ability to continue as a going concern; risks related to the recent COVID-19 coronavirus outbreak or other health epidemics, which could significantly impact the Company’s operations, sales or ability to raise capital or enroll patients in clinical trials and complete certain Tiara development milestones on the Company’s expected schedule; risks relating to the Company’s need for significant additional future capital and the Company’s ability to raise additional funding; risks relating to the sale of a significant number of Common Shares; risks relating to the possibility that the Company’s common shares (the “Common Shares”) may be delisted from the Nasdaq or the TSX, which could affect their market price and liquidity; risks relating to the Company’s conclusion that it did have effective internal control over financial reporting as of December 31, 2020 but not at December 31, 2019 and 2018; risks relating to the Common Share price being volatile; risks relating to the possibility that the Common Shares may be delisted from the Nasdaq or the TSX, which could affect their market price and liquidity; risks relating to the Company’s significant indebtedness, and its effect on the Company’s financial condition; risks relating to lawsuits that the Company is subject to, which could divert the Company’s resources and result in the payment of significant damages and other remedies; risks relating to claims by third-parties alleging infringement of their intellectual property rights; risks relating to the Company’s ability to establish, maintain and defend intellectual property rights in the Company’s products; risks relating to results from clinical trials of the Company’s products, which may be unfavorable or perceived as unfavorable; the Company’s history of losses and significant accumulated deficit; risks associated with product liability claims, insurance and recalls; risks relating to use of the Company’s products in unapproved circumstances, which could expose the Company to liabilities; risks relating to competition in the medical device industry, including the risk that one or more competitors may develop more effective or more affordable products; risks relating to the Company’s ability to achieve or maintain expected levels of market acceptance for the Company’s products, as well as the Company’s ability to successfully build its in-house sales capabilities or secure third-party marketing or distribution partners; risks relating to the Company’s ability to convince public payors and hospitals to include the Company’s products on their approved products lists; risks relating to new legislation, new regulatory requirements and the efforts of governmental and third-party payors to contain or reduce the costs of healthcare; risks relating to increased regulation, enforcement and inspections of participants in the medical device industry, including frequent government investigations into marketing and other business practices; risks relating to the extensive regulation of the Company’s products and trials by governmental authorities, as well as the cost and time delays associated therewith; risks relating to post-market regulation of the Company’s products; risks relating to health and safety concerns associated with the Company’s products and industry; risks relating to the Company’s manufacturing operations, including the regulation of the Company’s manufacturing processes by governmental authorities and the availability of two critical components of the Reducer; risks relating to the possibility of animal disease associated with the use of the Company’s products; risks relating to the manufacturing capacity of third-party manufacturers for the Company’s products, including risks of supply interruptions impacting the Company’s ability to manufacture its own products; risks relating to the Company’s dependence on limited products for substantially all of the Company’s current revenues; risks relating to the Company’s exposure to adverse movements in foreign currency exchange rates; risks relating to the possibility that the Company could lose its foreign private issuer status under U.S. federal securities laws; risks relating to the possibility that the Company could be treated as a “passive foreign investment company”; risks relating to breaches of anti-bribery laws by the Company’s employees or agents; risks relating to future changes in financial accounting standards and new accounting pronouncements; risks relating to the Company’s dependence upon key personnel to achieve its business objectives; risks relating to the Company’s ability to maintain strong relationships with physicians; risks relating to the sufficiency of the Company’s management systems and resources in periods of significant growth; risks relating to consolidation in the health care industry, including the downward pressure on product pricing and the growing need to be selected by larger customers in order to make sales to their members or participants; risks relating to the Company’s ability to successfully identify and complete corporate transactions on favorable terms or achieve anticipated synergies relating to any acquisitions or alliances; risks relating to conflicts of interests among the Company’s officers and directors as a result of their involvement with other issuers; and risks relating to anti-takeover provisions in the Company’s constating documents which could discourage a third-party from making a takeover bid beneficial to the Company’s shareholders. These risk factors and others relating to the Company are discussed in greater detail in the “Risk Factors” section of the Company’s Annual Information Form and in the Management’s Discussion and Analysis for the three and six months ended June 30, 2021 (copies of which may be obtained atwww.sedar.comorwww.sec.gov). The Company has no intention and undertakes no obligation to update or revise any forward-looking statements beyond required periodic filings with securities regulators, whether as a result of new information, future events or otherwise, except as required by law.