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

 

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

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

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

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

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

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

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

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

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

About OpRegen

OpRegen is currently being evaluated in a Phase 1/2a open-label, dose escalation safety and efficacy study of a single injection of human retinal pigment epithelium cells derived from an established pluripotent cell line and transplanted subretinally in patients with advanced dry AMD with GA. The study enrolled 24 patients into 4 cohorts. The first 3 cohorts enrolled only legally blind patients with BCVA of 20/200 or worse. The fourth cohort enrolled 12 better vision patients (BCVA from 20/65 to 20/250 with smaller mean areas of GA). Cohort 4 also included patients treated with a new “thaw-and-inject” formulation of OpRegen, which can be shipped directly to sites and used immediately upon thawing, removing the complications and logistics of having to use a dose preparation facility. The primary objective of the study is to evaluate the safety and tolerability of OpRegen as assessed by the incidence and frequency of treatment emergent adverse events. Secondary objectives are to evaluate the preliminary efficacy of OpRegen treatment by assessing the changes in ophthalmological parameters measured by various methods of primary clinical relevance. OpRegen has been well tolerated to date and there have been no new, unexpected ocular or systemic adverse events or serious adverse events that have not been previously reported. OpRegen is a registered trademark of 
Cell Cure Neurosciences Ltd., a majority-owned subsidiary of 
Lineage Cell Therapeutics, Inc.

About Age-Related Macular Degeneration

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

About Lineage Cell Therapeutics, Inc.

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include three allogeneic (“off-the-shelf”) product candidates: (i) OpRegen^®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC2, an allogeneic dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

Forward-Looking Statements

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

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

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

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

Source: 
Lineage Cell Therapeutics, Inc.

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

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

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

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

Event Page – View the Presentations Here

Register for Channechek to gain access to the Investor Event

Click the logos for more information on the presenting companies

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

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

 

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

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

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

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

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

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

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

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

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

About OpRegen

OpRegen is currently being evaluated in a Phase 1/2a open-label, dose escalation safety and efficacy study of a single injection of human retinal pigment epithelium cells derived from an established pluripotent cell line and transplanted subretinally in patients with advanced dry AMD with GA. The study enrolled 24 patients into 4 cohorts. The first 3 cohorts enrolled only legally blind patients with BCVA of 20/200 or worse. The fourth cohort enrolled 12 better vision patients (BCVA from 20/65 to 20/250 with smaller mean areas of GA). Cohort 4 also included patients treated with a new “thaw-and-inject” formulation of OpRegen, which can be shipped directly to sites and used immediately upon thawing, removing the complications and logistics of having to use a dose preparation facility. The primary objective of the study is to evaluate the safety and tolerability of OpRegen as assessed by the incidence and frequency of treatment emergent adverse events. Secondary objectives are to evaluate the preliminary efficacy of OpRegen treatment by assessing the changes in ophthalmological parameters measured by various methods of primary clinical relevance. OpRegen has been well tolerated to date and there have been no new, unexpected ocular or systemic adverse events or serious adverse events that have not been previously reported. OpRegen is a registered trademark of 
Cell Cure Neurosciences Ltd., a majority-owned subsidiary of 
Lineage Cell Therapeutics, Inc.

About Age-Related Macular Degeneration

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

About Lineage Cell Therapeutics, Inc.

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include three allogeneic (“off-the-shelf”) product candidates: (i) OpRegen^®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC2, an allogeneic dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

Forward-Looking Statements

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

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

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

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

Source: 
Lineage Cell Therapeutics, Inc.

Thursday, September 30, 2021

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

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

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

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

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


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

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary.  Proper due diligence is required before making any investment decision. 

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

 

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

Ottawa, ON /Business Wire/ September 29, 2021/ Avivagen Inc.  (TSXV:VIV, OTCQB:VIVXF) (“Avivagen”), a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications that safely enhances feed intake and supports immune function, thereby supporting general health and performance, has announced its unaudited financial results for the third quarter of 2021.

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

Q3 2021 highlights included:

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

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

Third Quarter: July 31, 2021, Financial Results

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

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

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

Significant financing inflows during the nine-month ending July 31, 2021, was an offering of 15,000,000 units of the Company at $0.50 per unit for aggregate gross proceeds of $7,500,000. The offering closed on February 16^th, 2021.

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

About Avivagen

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

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

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

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

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

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

For more information:
Avivagen Inc.

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

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

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

 

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

Ottawa, ON /Business Wire/ September 29, 2021/ Avivagen Inc.  (TSXV:VIV, OTCQB:VIVXF) (“Avivagen”), a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications that safely enhances feed intake and supports immune function, thereby supporting general health and performance, has announced its unaudited financial results for the third quarter of 2021.

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

Q3 2021 highlights included:

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

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

Third Quarter: July 31, 2021, Financial Results

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

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

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

Significant financing inflows during the nine-month ending July 31, 2021, was an offering of 15,000,000 units of the Company at $0.50 per unit for aggregate gross proceeds of $7,500,000. The offering closed on February 16^th, 2021.

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

About Avivagen

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

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

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

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

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

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

For more information:
Avivagen Inc.

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

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

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

 

Neovasc REDUCER-I Study Published in EuroIntervention Journal

 

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

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

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

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

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

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

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

 

About Reducer

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

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

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

 

About Neovasc Inc.

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

 

Investors

Mike Cavanaugh
Westwicke/ICR
Phone: +1.646.877.9641
Mike.Cavanaugh@westwicke.com

 

Media

SeanLeous
Westwicke/ICR
Phone: +1.646.866.4012
Sean.Leous@westwicke.com

 

Forward-Looking Statement Disclaimer

Certain statements in this news release contain forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and applicable Canadian securities laws that may not be based on historical fact. When used herein, the words “expect”, “anticipate”, “estimate”, “may”, “will”, “should”, “intend,” “believe”, and similar expressions, are intended to identify forward-looking statements. Forward-looking statements may involve, but are not limited to, the interpretations and implications of the REDUCER-I study, the efficacy of the Reducer as a therapy for patients who suffer from refractory angina, the procedural safety and success of the Reducer, the ORBITA-COSMIC study and COSIRA-II trials helpfulness to validating the Reducer, the building of evidence necessary to establish the Reducer as standard of care for patients suffering from refractory angina, the mounting supporting of Reducer therapy as a viable treatment option for patients that are suffering from angina-related chest pain and the growing cardiovascular marketplace. Many factors and assumptions could cause the Company’s actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements, including, without limitation, the doubt about the Company’s ability to continue as a going concern; risks related to the recent COVID-19 coronavirus outbreak or other health epidemics, which could significantly impact the Company’s operations, sales or ability to raise capital or enroll patients in clinical trials and complete certain Tiara development milestones on the Company’s expected schedule; risks relating to the Company’s need for significant additional future capital and the Company’s ability to raise additional funding; risks relating to the sale of a significant number of Common Shares; risks relating to the possibility that the Company’s common shares (the “Common Shares”) may be delisted from the Nasdaq or the TSX, which could affect their market price and liquidity; risks relating to the Company’s conclusion that it did have effective internal control over financial reporting as of December 31, 2020 but not at December 31, 2019 and 2018; risks relating to the Common Share price being volatile; risks relating to the possibility that the Common Shares may be delisted from the Nasdaq or the TSX, which could affect their market price and liquidity; risks relating to the Company’s significant indebtedness, and its effect on the Company’s financial condition; risks relating to lawsuits that the Company is subject to, which could divert the Company’s resources and result in the payment of significant damages and other remedies; risks relating to claims by third-parties alleging infringement of their intellectual property rights; risks relating to the Company’s ability to establish, maintain and defend intellectual property rights in the Company’s products; risks relating to results from clinical trials of the Company’s products, which may be unfavorable or perceived as unfavorable; the Company’s history of losses and significant accumulated deficit; risks associated with product liability claims, insurance and recalls; risks relating to use of the Company’s products in unapproved circumstances, which could expose the Company to liabilities; risks relating to competition in the medical device industry, including the risk that one or more competitors may develop more effective or more affordable products; risks relating to the Company’s ability to achieve or maintain expected levels of market acceptance for the Company’s products, as well as the Company’s ability to successfully build its in-house sales capabilities or secure third-party marketing or distribution partners; risks relating to the Company’s ability to convince public payors and hospitals to include the Company’s products on their approved products lists; risks relating to new legislation, new regulatory requirements and the efforts of governmental and third-party payors to contain or reduce the costs of healthcare; risks relating to increased regulation, enforcement and inspections of participants in the medical device industry, including frequent government investigations into marketing and other business practices; risks relating to the extensive regulation of the Company’s products and trials by governmental authorities, as well as the cost and time delays associated therewith; risks relating to post-market regulation of the Company’s products; risks relating to health and safety concerns associated with the Company’s products and industry; risks relating to the Company’s manufacturing operations, including the regulation of the Company’s manufacturing processes by governmental authorities and the availability of two critical components of the Reducer; risks relating to the possibility of animal disease associated with the use of the Company’s products; risks relating to the manufacturing capacity of third-party manufacturers for the Company’s products, including risks of supply interruptions impacting the Company’s ability to manufacture its own products; risks relating to the Company’s dependence on limited products for substantially all of the Company’s current revenues; risks relating to the Company’s exposure to adverse movements in foreign currency exchange rates; risks relating to the possibility that the Company could lose its foreign private issuer status under U.S. federal securities laws; risks relating to the possibility that the Company could be treated as a “passive foreign investment company”; risks relating to breaches of anti-bribery laws by the Company’s employees or agents; risks relating to future changes in financial accounting standards and new accounting pronouncements; risks relating to the Company’s dependence upon key personnel to achieve its business objectives; risks relating to the Company’s ability to maintain strong relationships with physicians; risks relating to the sufficiency of the Company’s management systems and resources in periods of significant growth; risks relating to consolidation in the health care industry, including the downward pressure on product pricing and the growing need to be selected by larger customers in order to make sales to their members or participants; risks relating to the Company’s ability to successfully identify and complete corporate transactions on favorable terms or achieve anticipated synergies relating to any acquisitions or alliances; risks relating to conflicts of interests among the Company’s officers and directors as a result of their involvement with other issuers; and risks relating to anti-takeover provisions in the Company’s constating documents which could discourage a third-party from making a takeover bid beneficial to the Company’s shareholders. These risk factors and others relating to the Company are discussed in greater detail in the “Risk Factors” section of the Company’s Annual Information Form and in the Management’s Discussion and Analysis for the three and six months ended June 30, 2021 (copies of which may be obtained atwww.sedar.comorwww.sec.gov). The Company has no intention and undertakes no obligation to update or revise any forward-looking statements beyond required periodic filings with securities regulators, whether as a result of new information, future events or otherwise, except as required by law.

Neovasc REDUCER-I Study Published in EuroIntervention Journal

 

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

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

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

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

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

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

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

 

About Reducer

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

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

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

 

About Neovasc Inc.

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

 

Investors

Mike Cavanaugh
Westwicke/ICR
Phone: +1.646.877.9641
Mike.Cavanaugh@westwicke.com

 

Media

SeanLeous
Westwicke/ICR
Phone: +1.646.866.4012
Sean.Leous@westwicke.com

 

Forward-Looking Statement Disclaimer

Certain statements in this news release contain forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and applicable Canadian securities laws that may not be based on historical fact. When used herein, the words “expect”, “anticipate”, “estimate”, “may”, “will”, “should”, “intend,” “believe”, and similar expressions, are intended to identify forward-looking statements. Forward-looking statements may involve, but are not limited to, the interpretations and implications of the REDUCER-I study, the efficacy of the Reducer as a therapy for patients who suffer from refractory angina, the procedural safety and success of the Reducer, the ORBITA-COSMIC study and COSIRA-II trials helpfulness to validating the Reducer, the building of evidence necessary to establish the Reducer as standard of care for patients suffering from refractory angina, the mounting supporting of Reducer therapy as a viable treatment option for patients that are suffering from angina-related chest pain and the growing cardiovascular marketplace. Many factors and assumptions could cause the Company’s actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements, including, without limitation, the doubt about the Company’s ability to continue as a going concern; risks related to the recent COVID-19 coronavirus outbreak or other health epidemics, which could significantly impact the Company’s operations, sales or ability to raise capital or enroll patients in clinical trials and complete certain Tiara development milestones on the Company’s expected schedule; risks relating to the Company’s need for significant additional future capital and the Company’s ability to raise additional funding; risks relating to the sale of a significant number of Common Shares; risks relating to the possibility that the Company’s common shares (the “Common Shares”) may be delisted from the Nasdaq or the TSX, which could affect their market price and liquidity; risks relating to the Company’s conclusion that it did have effective internal control over financial reporting as of December 31, 2020 but not at December 31, 2019 and 2018; risks relating to the Common Share price being volatile; risks relating to the possibility that the Common Shares may be delisted from the Nasdaq or the TSX, which could affect their market price and liquidity; risks relating to the Company’s significant indebtedness, and its effect on the Company’s financial condition; risks relating to lawsuits that the Company is subject to, which could divert the Company’s resources and result in the payment of significant damages and other remedies; risks relating to claims by third-parties alleging infringement of their intellectual property rights; risks relating to the Company’s ability to establish, maintain and defend intellectual property rights in the Company’s products; risks relating to results from clinical trials of the Company’s products, which may be unfavorable or perceived as unfavorable; the Company’s history of losses and significant accumulated deficit; risks associated with product liability claims, insurance and recalls; risks relating to use of the Company’s products in unapproved circumstances, which could expose the Company to liabilities; risks relating to competition in the medical device industry, including the risk that one or more competitors may develop more effective or more affordable products; risks relating to the Company’s ability to achieve or maintain expected levels of market acceptance for the Company’s products, as well as the Company’s ability to successfully build its in-house sales capabilities or secure third-party marketing or distribution partners; risks relating to the Company’s ability to convince public payors and hospitals to include the Company’s products on their approved products lists; risks relating to new legislation, new regulatory requirements and the efforts of governmental and third-party payors to contain or reduce the costs of healthcare; risks relating to increased regulation, enforcement and inspections of participants in the medical device industry, including frequent government investigations into marketing and other business practices; risks relating to the extensive regulation of the Company’s products and trials by governmental authorities, as well as the cost and time delays associated therewith; risks relating to post-market regulation of the Company’s products; risks relating to health and safety concerns associated with the Company’s products and industry; risks relating to the Company’s manufacturing operations, including the regulation of the Company’s manufacturing processes by governmental authorities and the availability of two critical components of the Reducer; risks relating to the possibility of animal disease associated with the use of the Company’s products; risks relating to the manufacturing capacity of third-party manufacturers for the Company’s products, including risks of supply interruptions impacting the Company’s ability to manufacture its own products; risks relating to the Company’s dependence on limited products for substantially all of the Company’s current revenues; risks relating to the Company’s exposure to adverse movements in foreign currency exchange rates; risks relating to the possibility that the Company could lose its foreign private issuer status under U.S. federal securities laws; risks relating to the possibility that the Company could be treated as a “passive foreign investment company”; risks relating to breaches of anti-bribery laws by the Company’s employees or agents; risks relating to future changes in financial accounting standards and new accounting pronouncements; risks relating to the Company’s dependence upon key personnel to achieve its business objectives; risks relating to the Company’s ability to maintain strong relationships with physicians; risks relating to the sufficiency of the Company’s management systems and resources in periods of significant growth; risks relating to consolidation in the health care industry, including the downward pressure on product pricing and the growing need to be selected by larger customers in order to make sales to their members or participants; risks relating to the Company’s ability to successfully identify and complete corporate transactions on favorable terms or achieve anticipated synergies relating to any acquisitions or alliances; risks relating to conflicts of interests among the Company’s officers and directors as a result of their involvement with other issuers; and risks relating to anti-takeover provisions in the Company’s constating documents which could discourage a third-party from making a takeover bid beneficial to the Company’s shareholders. These risk factors and others relating to the Company are discussed in greater detail in the “Risk Factors” section of the Company’s Annual Information Form and in the Management’s Discussion and Analysis for the three and six months ended June 30, 2021 (copies of which may be obtained atwww.sedar.comorwww.sec.gov). The Company has no intention and undertakes no obligation to update or revise any forward-looking statements beyond required periodic filings with securities regulators, whether as a result of new information, future events or otherwise, except as required by law.

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

 

	Image Credit: Christine Daniloff, (MIT, stock images)

Vaccinating Against Certain Proteins Found on Cancer Cells Could Help Enhance the T Cell Response to Tumors

 

Anne Trafton | 
MIT News Office

Over the past decade, scientists have been exploring vaccination as a way to help fight cancer. These experimental cancer vaccines are designed to stimulate the body’s own immune system to destroy a tumor, by injecting fragments of cancer proteins found on the tumor.

So far, none of these vaccines have been approved by the FDA, but some have shown promise in clinical trials to treat melanoma and some types of lung cancer. In a new finding that may help researchers decide what proteins to include in cancer vaccines, MIT researchers have found that vaccinating against certain cancer proteins can boost the overall T cell response and help to shrink tumors in mice.

The research team found that vaccinating against the types of proteins they identified can help to reawaken dormant T cell populations that target those proteins, strengthening the overall immune response.

“This study highlights the importance of exploring the details of immune responses against cancer deeply. We can now see that not all anticancer immune responses are created equal, and that vaccination can unleash a potent response against a target that was otherwise effectively ignored,” says Tyler Jacks, the David H. Koch Professor of Biology, a member of the Koch Institute for Integrative Cancer Research, and the senior author of the study.

MIT postdoc Megan Burger is the lead author of the new study, which appears today in Cell.

T Cell Competition

When cells begin to turn cancerous, they start producing mutated proteins not seen in healthy cells. These cancerous proteins, also called neoantigens, can alert the body’s immune system that something has gone wrong, and T cells that recognize those neoantigens start destroying the cancerous cells.

Eventually, these T cells experience a phenomenon known as “T cell exhaustion,” which occurs when the tumor creates an immunosuppressive environment that disables the T cells, allowing the tumor to grow unchecked.

Scientists hope that cancer vaccines could help to rejuvenate those T cells and help them to attack tumors. In recent years, they have worked to develop methods for identifying neoantigens in patient tumors to incorporate into personalized cancer vaccines. Some of these vaccines have shown promise in clinical trials to treat melanoma and non-small cell lung cancer.

“These therapies work amazingly in a subset of patients, but the vast majority still don’t respond very well,” Burger says. “A lot of the research in our lab is aimed at trying to understand why that is and what we can do therapeutically to get more of those patients responding.”

Previous studies have shown that of the hundreds of neoantigens found in most tumors, only a small number generate a T cell response.

The new MIT study helps to shed light on why that is. In studies of mice with lung tumors, the researchers found that as tumor-targeting T cells arise, subsets of T cells that target different cancerous proteins compete with each other, eventually leading to the emergence of one dominant population of T cells. After these T cells become exhausted, they still remain in the environment and suppress any competing T cell populations that target different proteins found on the tumor.

However, Burger found that if she vaccinated these mice with one of the neoantigens targeted by the suppressed T cells, she could rejuvenate those T cell populations.

“If you vaccinate against antigens that have suppressed responses, you can unleash those T cell responses,” she says. “Trying to identify these suppressed responses and specifically targeting them might improve patient responses to vaccine therapies.”

Shrinking Tumors

In this study, the researchers found that they had the most success when vaccinating with neoantigens that bind weakly to immune cells that are responsible for presenting the antigen to T cells. When they used one of those neoantigens to vaccinate mice with lung tumors, they found the tumors shrank by an average of 27 percent.

“The T cells proliferate more, they target the tumors better, and we see an overall decrease in lung tumor burden in our mouse model as a result of the therapy,” Burger says.

After vaccination, the T cell population included a type of cells that have the potential to continuously refuel the response, which could allow for long-term control of a tumor.

In future work, the researchers hope to test therapeutic approaches that would combine this vaccination strategy with cancer drugs called checkpoint inhibitors, which can take the brakes off exhausted T cells, stimulating them to attack tumors. Supporting that approach, the results published today also indicate that vaccination boosts the number of a specific type of T cells that have been shown to respond well to checkpoint therapies.

The research was funded by the Howard Hughes Medical Institute,
the Ludwig Center at Harvard University, the National Institutes of Health, the
Koch Institute Support (core) Grant from the National Cancer Institute, the
Bridge Project of the Koch Institute and Dana-Farber/Harvard Cancer Center, and
fellowship awards from the Jane Coffin Childs Memorial Fund for Medical
Research and the Ludwig Center for Molecular Oncology at MIT.

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Onconova Therapeutics, Inc. Announces Pricing Of $21 Million Public Offering Of Common Stock

 

NEWTOWN, Pa., Sept. 24, 2021 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX) (“Onconova”), a biopharmaceutical company focused on discovering and developing novel products to treat cancer, today announced the pricing of an underwritten public offering of 5,000,000 shares of its common stock at a public offering price of $4.20 per share. The gross proceeds of the offering to the Company are expected to be $21 million, before deducting the underwriting discounts and commissions and other estimated offering expenses. In addition, Onconova granted the underwriters a thirty-day option to purchase up to an additional 750,000 shares of common stock at the public offering price, less underwriting discounts and commissions.

The closing of the offering is expected to occur on or about September 28, 2021, subject to the satisfaction of customary closing conditions.

Guggenheim Securities is acting as sole book-running manager. Ladenburg Thalmann & Co. Inc. and Noble Capital Markets, Inc. are acting as co-managers for the offering.

The securities described above are being offered by Onconova pursuant to a shelf registration statement on Form S-3 (File No. 333-237844) which was initially filed by the Company with the Securities and Exchange Commission (the “SEC”) on April 24, 2020, amended on Form S-3/A that was filed with the SEC on May 15, 2020, and was declared effective by the SEC on May 18, 2020.

A preliminary prospectus supplement relating to the offering was filed with the SEC on September 23, 2021 and is available on the SEC’s website at http://www.sec.gov. The final prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and also will be available on the SEC’s website. Before investing in the offering, you should read each of the prospectus supplement and the accompanying prospectus relating to the offering in their entirety as well as the other documents that the Company has filed with the SEC that are incorporated by reference in the prospectus supplement and the accompanying prospectus relating to the offering, which provide more information about the Company and the offering. Copies of the final prospectus supplement, when available, and accompanying prospectus relating to the offering may be obtained from Guggenheim Securities, LLC Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017 or by telephone at (212) 518-9544, or by email at GSEquityProspectusDelivery@guggenheimpartners.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Onconova Therapeutics, Inc.

Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.

Onconova’s novel, proprietary multi-kinase inhibitor ON 123300 is being evaluated in two separate and complementary Phase 1 dose-escalation and expansion studies. These trials are currently underway in the United States and China.

Onconova’s product candidate rigosertib is being studied in an investigator-initiated study program, including in a dose-escalation and expansion Phase 1/2a investigator-initiated study with oral rigosertib in combination with nivolumab for patients with KRAS+ non-small cell lung cancer.

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. These statements relate to Onconova’s expectations regarding the offering, its patents and clinical development plans including patient enrollment timelines and indications for its product candidates. Onconova has attempted to identify forward-looking statements by terminology including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey uncertainty of future events or outcomes. Although Onconova believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Onconova’s clinical trials and regulatory agency and institutional review board approvals of protocols, Onconova’s ability to continue as a going concern, the need for additional financing, Onconova’s collaborations, market conditions and those discussed under the heading “Risk Factors” in Onconova’s most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q. Any forward-looking statements contained in this release speak only as of its date. Onconova undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

General Contact

Avi Oler
Onconova Therapeutics, Inc.
267-759-3680
ir@onconova.us
http://www.onconova.com/contact/

Onconova Therapeutics, Inc. Announces Pricing Of $21 Million Public Offering Of Common Stock

 

NEWTOWN, Pa., Sept. 24, 2021 (GLOBE NEWSWIRE) — Onconova Therapeutics, Inc. (NASDAQ: ONTX) (“Onconova”), a biopharmaceutical company focused on discovering and developing novel products to treat cancer, today announced the pricing of an underwritten public offering of 5,000,000 shares of its common stock at a public offering price of $4.20 per share. The gross proceeds of the offering to the Company are expected to be $21 million, before deducting the underwriting discounts and commissions and other estimated offering expenses. In addition, Onconova granted the underwriters a thirty-day option to purchase up to an additional 750,000 shares of common stock at the public offering price, less underwriting discounts and commissions.

The closing of the offering is expected to occur on or about September 28, 2021, subject to the satisfaction of customary closing conditions.

Guggenheim Securities is acting as sole book-running manager. Ladenburg Thalmann & Co. Inc. and Noble Capital Markets, Inc. are acting as co-managers for the offering.

The securities described above are being offered by Onconova pursuant to a shelf registration statement on Form S-3 (File No. 333-237844) which was initially filed by the Company with the Securities and Exchange Commission (the “SEC”) on April 24, 2020, amended on Form S-3/A that was filed with the SEC on May 15, 2020, and was declared effective by the SEC on May 18, 2020.

A preliminary prospectus supplement relating to the offering was filed with the SEC on September 23, 2021 and is available on the SEC’s website at http://www.sec.gov. The final prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and also will be available on the SEC’s website. Before investing in the offering, you should read each of the prospectus supplement and the accompanying prospectus relating to the offering in their entirety as well as the other documents that the Company has filed with the SEC that are incorporated by reference in the prospectus supplement and the accompanying prospectus relating to the offering, which provide more information about the Company and the offering. Copies of the final prospectus supplement, when available, and accompanying prospectus relating to the offering may be obtained from Guggenheim Securities, LLC Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017 or by telephone at (212) 518-9544, or by email at GSEquityProspectusDelivery@guggenheimpartners.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Onconova Therapeutics, Inc.

Onconova Therapeutics is a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer. The Company has proprietary targeted anti-cancer agents designed to disrupt specific cellular pathways that are important for cancer cell proliferation.

Onconova’s novel, proprietary multi-kinase inhibitor ON 123300 is being evaluated in two separate and complementary Phase 1 dose-escalation and expansion studies. These trials are currently underway in the United States and China.

Onconova’s product candidate rigosertib is being studied in an investigator-initiated study program, including in a dose-escalation and expansion Phase 1/2a investigator-initiated study with oral rigosertib in combination with nivolumab for patients with KRAS+ non-small cell lung cancer.

Forward-Looking Statements

Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties. These statements relate to Onconova’s expectations regarding the offering, its patents and clinical development plans including patient enrollment timelines and indications for its product candidates. Onconova has attempted to identify forward-looking statements by terminology including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey uncertainty of future events or outcomes. Although Onconova believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Onconova’s clinical trials and regulatory agency and institutional review board approvals of protocols, Onconova’s ability to continue as a going concern, the need for additional financing, Onconova’s collaborations, market conditions and those discussed under the heading “Risk Factors” in Onconova’s most recent Annual Report on Form 10-K and quarterly reports on Form 10-Q. Any forward-looking statements contained in this release speak only as of its date. Onconova undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

General Contact

Avi Oler
Onconova Therapeutics, Inc.
267-759-3680
ir@onconova.us
http://www.onconova.com/contact/