Avivagen to Hold Webcast to Discuss Landmark Deal with AB Vista


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 Following the live webcast, an archived version of the call will be available on Avivagen’s website.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: [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
Copyright © 2021 Avivagen Inc. OxC-beta™ is a trademark of Avivagen Inc.

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

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. 

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


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 Avivagens products may not continue to grow and could decline, Avivagens 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 Avivagens control.  Readers are referred to the risk factors associated with the business of Avivagen set out in Avivagens most recent managements 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
+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

Opportunities in the Rapidly Growing Pain Management Sector


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. (
NAOVis 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.

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 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

Stay up to date. Follow us:

 

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


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 Avivagens products may not continue to grow and could decline, Avivagens 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 Avivagens control.  Readers are referred to the risk factors associated with the business of Avivagen set out in Avivagens most recent managements 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
+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

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

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. 

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


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 – Presenting Companies

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.


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.

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

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. 

Release – Avivagen Inc. Announces Results for the Third Quarter Ending July 31 2021


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-betaTM Livestock from UNAHCO
    • Secured a 500 kg order for OxC-betaTM 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 16th, 2021.

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

About Avivagen

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

About OxC-beta™ Technology and OxC-beta™ Livestock

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

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

Forward Looking Statements
This news release includes certain forward-looking statements that are based upon the current expectations of management. Forward-looking statements involve risks and uncertainties associated with the business of Avivagen Inc. and the environment in which the business operates. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking, including those identified by the expressions aim”, anticipate”, appear”, believe”, consider”, could”, estimate”, expect”, if”, intend”, goal”, hope”, likely”, may”, plan”, possibly”, potentially”, pursue”, seem”, should”, whether”, will”, would” and similar expressions. Statements set out in this news release relating to Avivagen’s 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 Avivagens products may not continue to grow and could decline, Avivagens 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 Avivagens control.  Readers are referred to the risk factors associated with the business of Avivagen set out in Avivagens most recent managements 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


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-betaTM Livestock from UNAHCO
    • Secured a 500 kg order for OxC-betaTM 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 16th, 2021.

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

About Avivagen

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

About OxC-beta™ Technology and OxC-beta™ Livestock

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

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

Forward Looking Statements
This news release includes certain forward-looking statements that are based upon the current expectations of management. Forward-looking statements involve risks and uncertainties associated with the business of Avivagen Inc. and the environment in which the business operates. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking, including those identified by the expressions aim”, anticipate”, appear”, believe”, consider”, could”, estimate”, expect”, if”, intend”, goal”, hope”, likely”, may”, plan”, possibly”, potentially”, pursue”, seem”, should”, whether”, will”, would” and similar expressions. Statements set out in this news release relating to Avivagen’s 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 Avivagens products may not continue to grow and could decline, Avivagens 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 Avivagens control.  Readers are referred to the risk factors associated with the business of Avivagen set out in Avivagens most recent managements 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

Release – Genprex Strengthens Management Team with Appointments of Industry Leaders


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

 

Seasoned innovative drug development executives bolster leadership with relevant domain expertise as Company advances key Acclaim-1 and Acclaim-2 clincial trials of REQORSA systemic gene therapy in non-small cell lung cancer and works to expand technology pipeline

AUSTIN, Texas — (September 28, 2021) — Genprex, Inc. (“Genprex” or the “Company”) (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced that the Company has strengthened its leadership team with the appointments of Mark S. Berger, M.D. to the newly-created position of Chief Medical Officer and Hemant Kumar, Ph.D., CPM, EMBA to the newly-created position of Chief Manufacturing and Technology Officer.  Drs. Berger and Kumar will report to  Rodney Varner, Chief Executive Officer of Genprex. 

“It is my priviledge and pleasure to welcome Mark and Hemant to our management team.  Their collective accomplishments and deep domain expertise in clinical development and gene therapy manufacturing, respectively, will be of great value as they help guide Genprex and advance our important Acclaim-1 and Acclaim-2 clinical trials in non-small cell lung cancer this year,” stated Mr. Varner.  “As we continue to make progress with these studies, and to expand our technology pipeline, it is more important than ever to have medical affairs and manufacturing in such capable hands.”

“I am delighted to join the growing team at Genprex, confident that my experience designing and managing pivotal clinical trials in oncology will provide valuable insight and oversight for Genprex’ novel gene therapy pipeline,” commented Dr. Berger. “Advancing the first systemic gene therapy in oncology is  a uniquely exciting opportunity to transform cancer care for patients with limited treatment options and I am looking forward to working with Genprex’ leadership team to help develop this new approach to cancer treatment.”  

“I am delighted to join the management team at Genprex and to work alongside this group of seasoned executives to realize the potential for its novel systemic gene therapy to improve outcomes for cancer patients,” noted Dr. Kumar.  “I am eager to apply my expertise and technical background in accelerated development of innovative biologics and advanced cell and gene therapies to support Genprex’ already impressive work and drive its technologies to commercialization.” 

About Mark S. Berger

Dr. Berger is an oncologist and senior executive with 25 years of biotech and pharmaceutical company experience in the development of oncology therapeutics.  He has successfully brought two drugs through the regulatory process to approval and excels in strategic development, team management and collaborative leadership. Dr. Berger joins Genprex from Actinium Pharmaceuticals, Inc. where since January 2017 he served as Chief Medical Officer and was responsible for clinical strategy and development of radioisotope-labeled antibodies for therapy in oncology, including the Company’s Phase 3 SIERRA trial.  Before that, Dr. Berger was Senior Vice President-Clinical Research at Kadmon Corporation from 2013 through 2017, where he led all aspects of the company’s new drug development, including clinical trial design and management of the oncology programs in non-small cell lung cancer and breast cancer, among others. 

Prior to that, Dr. Berger was Chief Medical Officer of Deciphera Pharmaceuticals from June 2011 to September 2013. Before Deciphera, Dr. Berger was Vice President for Clinical Development at Gemin X Pharmaceuticals, where he led the clinical strategy, design and management of clinical trials for two novel oncology agents including obatoclax. Based on the results of a randomized Phase 2 clinical trial of obatoclax, Gemin X was acquired by Cephalon in March of 2011. Before his work with biotechnology companies, Dr. Berger held key positions in two global pharmaceutical companies. Dr. Berger previously served as Group Director, Medicine Development Centre-Oncology for GlaxoSmithKline. In this position Dr. Berger managed the development of Tykerb (lapatinib) in lung and breast cancer where he designed and led two Phase 2 clinical trials before planning and leading a 399 patient pivotal Phase 3 trial that resulted in the FDA approval of Tykerb in breast cancer. In addition, he managed the Lapatinib Expanded Access Program that enrolled over 4000 patients on a global basis. Dr. Berger began his career in drug development at Wyeth Research where he led the planning and execution of the pivotal Phase 2 trial for Mylotarg, which was the first antibody targeted chemotherapy agent. He presented the Mylotarg clinical data at the FDA’s Oncology Drug Advisory Committee meeting, after which Mylotarg received accelerated FDA approval for patients with relapsed AML.

Dr. Berger holds a B.A. in biology from Wesleyan University and a M.D. from the University of Virginia School of Medicine. He did his Hematology/Oncology fellowship at the University of Pennsylvania, where he was an Assistant Professor of Medicine, and also was a Research Fellow at the Ludwig Institute for Cancer Research and the Imperial Cancer Research Fund, both in London. Dr. Berger is board certified in internal medicine, hematology and medical oncology. 

About Hemant Kumar, Ph.D., CPM, EMBA

Dr. Kumar is a recognized global expert in Chemistry, Manufacture and Controls (CMC) Technical Development and GMP manufacturing.  He has a greater than 25-year track record leading global CMC and regulatory approval strategy for accelerated development of innovative vaccines, biologics, advanced cell & gene therapy drug process and product development (Ph1 to Ph3 and commercialization) under current GMP, and licensing processes. Dr. Kumar joins Genprex from Arcturus Therapeutics, Inc., where he served as Strategic Advisor and then Vice President, Global Head of Manufacturing, Supply Chain, and Strategy.  Prior to that, Dr. Kumar was Vice President of CMC Technical Development & Manufacturing Operations at Oncoimmune Therapeutics, Inc., a private company that was acquired by Merck & Co. during his tenure there.  Before that, he was Vice President, Head of Global Process Sciences and Clinical Manufacturing Operations at Rentscher BioPharma, SE.  Previous to that, Dr. Kumar was with Anaptysbio, Inc., where he served as Senior Vice President, Head of Global CMC, Technical Development and Manufacturing Operations.   Before that, Dr. Kumar held senior level positions of increasing manufacturing and technical operations leadership in global biopharmaceutical companies including Merck & Co., Inc.,  Sanofi Genzyme, Inc., Lonza Biologics, Inc., Sanofi Pasteur, Janssen Biotech ( a Johnson & Johnson company) and Wyeth Lederle Vaccines, Inc.

Dr. Kumar earned his Ph.D. in Biochemistry at J.N. Medical College, Aligarth India through a collaboration with the U.S. National Institutes of Health. He holds a graduate certificate in Project Management from Lehigh University School of Management.  Dr. Kumar has conducted postdoctoral and research scientist fellowships at Yale University School of Medicine, the University of Rhode Island and the Center for Disease Control and Prevention’s Center for Infectious Diseases.  He holds professional affilations with the American Chemical Society, American Association for the Advancement of Science, Americal Society for Microbiology and the International Society of Pharmaceutical Engineers.  

Inducement Grants

The Company has granted 550,000 options to Dr. Berger at an exercise price equal to $2.85, the closing price of our common stock on September 27, 2021, the date of grant. While these options were not granted under Genprex’s 2018 Equity Incentive Plan (the “Plan”), the awards will incorporate the terms of the Plan.  The options vest as to one-third of the shares over the next three years and are exercisable for a period of ten years subject to continued service to the Company.

The Company has granted 400,000 options to Dr. Kumar at an exercise price equal to $2.85, the closing price of our common stock on September 27, 2021, the date of grant. While these options were not granted under the Plan, the awards will incorporate the terms of the Plan.  The options vest as to one-third of the shares over the next three years and are exercisable for a period of ten years subject to continued service to the Company.

About Genprex, Inc.

Genprex, Inc. is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes. Genprex’s technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes who currently have limited treatment options. Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches. Genprex’s oncology program utilizes its unique, proprietary, non-viral ONCOPREX® Nanoparticle Delivery System, which the Company believes is the first systemic gene therapy delivery platform used for cancer in humans. ONCOPREX encapsulates the gene-expressing plasmids using lipid nanoparticles. The resultant product is then administered intravenously, where it is then taken up by tumor cells that express proteins that are deficient. The Company’s lead product candidate, REQORSA™ (quaratusugene ozeplasmid), is being evaluated as a treatment for non-small cell lung cancer (NSCLC). REQORSA has a multimodal mechanism of action that has been shown to interrupt cell signaling pathways that cause replication and proliferation of cancer cells; re-establish pathways for apoptosis, or programmed cell death, in cancer cells; and modulate the immune response against cancer cells. REQORSA has also been shown to block mechanisms that create drug resistance. In January 2020, the U.S. Food and Drug Administration granted Fast Track Designation for REQORSA for NSCLC in combination therapy with AstraZeneca’s Tagrisso® (osimertinib) for patients with EFGR mutations whose tumors progressed after treatment with Tagrisso.

For more information, please visit the Company’s web site at www.genprex.com or follow Genprex on TwitterFacebook and LinkedIn.

Cautionary Language Concerning Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of management, are not guarantees of performance and are subject to significant risks and uncertainty. These forward-looking statements should, therefore, be considered in light of various important factors, including those set forth in Genprex’s reports that it files from time to time with the Securities and Exchange Commission and which you should review, including those statements under “Item 1A – Risk Factors” in Genprex’s Annual Report on Form 10-K.

Because forward-looking statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: the timing and success of Genprex’s clinical trials and regulatory approvals; the effect of Genprex’s product candidates, alone and in combination with other therapies, on cancer and diabetes;  Genprex’s future growth and financial status; Genprex’s commercial and strategic partnerships including the scale up of the manufacture of its product candidates; and Genprex’s intellectual property and licenses.

These forward-looking statements should not be relied upon as predictions of future events and Genprex cannot assure you that the events or circumstances discussed or reflected in these statements will be achieved or will occur. If such forward-looking statements prove to be inaccurate, the inaccuracy may be material. You should not regard these statements as a representation or warranty by Genprex or any other person that Genprex will achieve its objectives and plans in any specified timeframe, or at all. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Genprex disclaims any obligation to publicly update or release any revisions to these forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release or to reflect the occurrence of unanticipated events, except as required by law.

Genprex, Inc.

(877) 774-GNPX (4679)

Investor Relations

GNPX Investor Relations

(877) 774-GNPX (4679) ext. #2

Media Contact

Genprex Media Relations

Anne Marie Fields

(877) 774-GNPX (4679) ext. #3