OpRegen® Clinical Data Continues To Demonstrate Improvements In Patients With Dry AMD With Geographic Atrophy

 

• Eighty-Three Percent of All Cohort 4 Patients Exhibited Stable or Improved BCVA
• Visual Acuity Declined in the Majority of Untreated Eyes
• Positive Interim Outcomes on Patient-Reported Visual Function Questionnaire
• No Acute or Delayed Inflammation or Rejection Events, Even in Patients Receiving Reduced Immunosuppressive Regimen
• Previously Reported Evidence of Retinal Restoration Has Persisted to Month 35
• Data Reported at 2021 ARVO Meeting

CARLSBAD, Calif.–(BUSINESS WIRE)–May 3, 2021– 

Lineage Cell Therapeutics, Inc.
 (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, announced today that updated interim results from its ongoing, 24-patient Phase 1/2a clinical study of its lead product candidate, OpRegen, were reported at the 2021 Association for Research in Vision and Ophthalmology Annual Meeting (ARVO 2021). OpRegen is an investigational cell therapy consisting of allogeneic retinal pigment epithelium (RPE) cells administered to the subretinal space for the treatment of dry age-related macular degeneration (AMD) with geographic atrophy (GA). At ARVO 2021, additional data were presented on 24 patients enrolled in the study, including all 12 patients treated in Cohort 4, which have better baseline vision and smaller areas of GA than earlier cohorts.

“I continue to be very excited about this work and the clinical data generated to date with OpRegen, especially in the better vision Cohort 4 patients,” stated Principal Investigator  Christopher D. Riemann, M.D., Vitreoretinal Surgeon and Fellowship Director, 
Cincinnati Eye Institute and 
University of Cincinnati School of Medicine. “There seems to be a significant visual acuity signal in Cohort 4 patients, with most treated eyes having stable or improved vision over time when compared to the contralateral eyes having stable or worsening vision over time. When looking at reading speed progression, treated eyes also seemed to improve while untreated eyes declined. Notably, some individual responders had impressive visual acuity improvements and reductions in GA progression compared to their contralateral eyes. Most importantly, we believe that earlier intervention in less severely affected patients along with a more central placement of transplanted OpRegen cells may increase the likelihood of a clinically beneficial effect. Overall, these results are encouraging and are of a magnitude that could be clinically very important if confirmed in further clinical studies.”

“These new data continue to indicate to us that treatment with OpRegen can generate clinically meaningful outcomes in dry AMD patients with GA, particularly in those with earlier-stage disease,” stated  Brian M. Culley, Lineage CEO. “It also appears that earlier intervention in less severely affected patients and more central placement of the transplanted cells may increase the likelihood of observing a benefit. Additionally, among the newly reported data, it was notable that Cohort 4 patients reported improvements in a majority of the vision parameters measured by a validated quality of life questionnaire. The magnitude of these improvements was higher overall in Cohort 4 than in Cohorts 1 through 3, which is consistent with the larger clinical benefit observed among those patients. As this data set matures, our efforts turn next to evaluating the six most recently treated Cohort 4 patients for indications of retinal restoration and reductions in the size and growth of the areas of GA. Our overall objective is to position OpRegen RPE transplants as the clear leader in the race to address the large unmet need in dry AMD with GA and establish Lineage as the pre-eminent allogeneic cell therapy company.”

Updated results presented at ARVO 2021 included a minimum of 4.5 months of follow-up in all 24 patients treated with OpRegen. Nine of twenty-four patients were treated with the “thaw and inject” formulation of OpRegen, two via a standard pars plana vitrectomy (PPV) and seven utilizing the Orbit™ Subretinal Delivery System (Orbit SDS).

Overall, 10/12 (83%) of the Cohort 4 patients’ treated eyes were at or above baseline visual acuity at their last assessment, based on per protocol scheduled visits ranging from 4.5 months to approximately 3 years post-transplant. Improvements in best corrected visual acuity (BCVA) for Cohort 4 patients reached up to +19 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. In contrast, 10/12 (83%) of the patients’ untreated eyes were below pre-treatment baseline values at the same time points. Among the newly reported data, three (50%) of the more recently treated Cohort 4 patients exhibited marked improvements in BCVA ranging from +7 to +16 letters at their last scheduled assessments of at least 4.5 months. Two additional Cohort 4 patients experienced a gain of 2 letters from their baseline values. One Cohort 4 patient measured 7 letters below baseline. Previously reported structural improvements in the retina, decreases in drusen density, and a trend toward slower GA progression in treated compared to untreated eyes continued. Overall, OpRegen has been well tolerated with no unexpected adverse events or serious adverse events, and evidence of durable engraftment of OpRegen RPE cells have extended to more than 5 years in earliest treated patients, supporting the potential for OpRegen to be a one-time treatment.

A Cohort 4 patient with evidence of retinal restoration and confirmed history of GA growth, which was first reported 9 months following treatment, continues to demonstrate areas of retinal restoration as of their last assessment, approximately 3 years after treatment.

2021 ARVO Presentation OpRegen Data Highlights (As of April 16, 2021):

• In Cohort 1-3 patients (all legally blind at baseline), visual acuity reductions occurred as expected due to progressive GA;
• In Cohort 4 patients, which collectively had smaller areas of GA and higher baseline BCVA as compared to Cohort 1-3 patients, improved or sustained BCVA has been observed in 10/12 (83%) patients as of their last visit prior to this update (range of -7 to +19 letters on the ETDRS chart);
• OpRegen continues to be well-tolerated in all treated patients (N = 24);
• The majority of adverse events were mild (87%);
• Sustained subretinal pigmentation continues to suggest multi-year durability of OpRegen transplants;
• Improved anatomy and function continue to be observed in some patients, including:
  • Reduction in drusen;
  • Photoreceptor and RPE layer restoration;
  • Localized slowing of GA progression in treated areas;
  • Better visual acuity via ETDRS scores and reading speed; and
  • Improved National Eye Institute Visual Function Questionnaire (VFQ-25) scores.
• Post-treatment surgical interventions occurred in four cases (5 events in 4 patients):
  • Three epiretinal membranes (ERM) were surgically peeled. Mild to moderate ERM were observed in an additional 12 out of 17 PPV operated patients. Most ERMs were clinically insignificant.
  • Retinal detachment (RD) was observed in 2 out of 17 patients, neither of which appears to be attributable to OpRegen or any study related medications:
    • The first case of RD, which occurred in a Cohort 3 patient, was an unsuccessful repair of a post-surgical retinal tear; visual acuity did not regain baseline levels; and
    • The second case of RD, which occurred in a Cohort 4 patient, was successfully repaired; post-surgical visual acuity has remained higher than baseline.
• Choroidal neovascularization (CNV) was observed in 3 out of 7 patients receiving OpRegen via the Orbit SDS, all of whom received treatment with an approved anti-VEGF;
• As previously reported, one PPV operated patient developed CNV, which was identified more than two years following treatment.

As part of an ongoing effort to administer the minimally effective dose and duration of immunosuppressive therapy, immunosuppression was utilized only during the perioperative period of approximately 3 months in Cohort 4 patients. One patient received a modified immunosuppressive regimen at baseline, which included no tacrolimus and only mycophenolate mofetil. One patient was diagnosed with COVID-19 shortly after treatment for whom all immunosuppression was halted and reinstated once the patient was asymptomatic. Both patients showed no signs of acute or delayed inflammation or rejection of OpRegen cells with 4.5 months of post-transplant follow up. Other than the reduced regimens described above, immunosuppressants have been discontinued as scheduled, typically within 90 days post-operatively, and no cases of acute or delayed rejection or inflammation due to OpRegen have been reported in any patients treated with OpRegen.

The presentation, “Phase I/IIa Clinical Trial of Transplanted Allogeneic Retinal Pigmented Epithelium (RPE, OpRegen) Cells in Advanced Dry Age-Related Macular Degeneration (AMD): Interim Results” is being featured as part of the Stem Cells/Gene Therapy/Transplantation Session, on 
May 6, 2021 
between 5:15 pm and 6:45 pm EDT by 
Christopher D. Riemann, M.D.(abstract number 3538173).

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 (vision from 20/65 to 20/250 with smaller 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. Additional objectives include the evaluation of the safety of delivery of OpRegen using the Orbit SDS. OpRegen is a registered trademark of 
Cell Cure Neurosciences Ltd., a majority-owned subsidiary of 
Lineage Cell Therapeutics, Inc. The Orbit subretinal delivery system is used under agreement with 
Gyroscope Therapeutics Limited. Orbit and Orbit SDS are trademarks of 
Gyroscope Therapeutics Limited.

About Dry AMD

Dry age-related macular degeneration (AMD) is a leading cause of adult blindness in the developed world. There are two forms of AMD: wet AMD and dry AMD. Dry AMD is the more common of the two types, accounting for approximately 85-90% of cases. Wet AMD is the less common of the two types, accounting for approximately 10-15% of cases. Global sales of the two leading wet AMD therapies were in excess of 
$10 billion in 2019. Nearly all cases of wet AMD begin as dry AMD. Dry AMD typically affects both eyes. There are currently no 
U.S. Food and Drug Administration or 
European Medicines Agency approved treatment options available for patients with dry 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) 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.

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,” “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 expected clinical outcomes of treatment with OpRegen in dry AMD patients with GA. 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 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
Gitanjali Jain Ogawa
(Gogawa@soleburytrout.com)
(646) 378-2949

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

Source: 
Lineage Cell Therapeutics, Inc.

Cocrystal Pharma Provides Update on its COVID-19 Antiviral Discovery and Development Programs

 

BOTHELL, Wash., May 03, 2021 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP), (“Cocrystal” or the “Company”), a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication machinery of influenza viruses, coronaviruses, hepatitis C viruses and noroviruses, announces progress in developing broad-spectrum antiviral drug candidates that target coronaviruses including SARS-CoV-2, the coronavirus that causes COVID-19. Cocrystal initiated its COVID-19 program in March 2020 and has since expanded the program with additional development and licensing.

“We are aggressively developing novel coronavirus protease inhibitors for COVID-19 prophylactic and therapeutic use,” said Sam Lee, Ph.D., President of Cocrystal. “These drug candidates bind to a highly conserved region of the active site of SARS-CoV-2 protease that is required for SARS-CoV-2 viral replication. Our high-resolution x-ray cocrystal structures further confirmed the specific covalent interaction with this conserved region of the proteases of the coronaviruses SARS-CoV-2, SARS-CoV and MERS-CoV viruses.

“We believe that, due to their novel mechanism of action, our protease inhibitors are likely to be effective against new variants of SARS-CoV-2. This may include the recent variants first identified in the United Kingdom, South Africa, Brazil and India, which may be more contagious forms of the virus and may evade immunity produced by vaccines or previous infection,” he added.

Lead candidate CDI-45205

In December 2020 Cocrystal announced the selection of CDI-45205 as its lead coronavirus development candidate among a group of protease inhibitors obtained under an exclusive license agreement with Kansas State University Research Foundation (KSURF) announced in 2020.

CDI-45205 showed good bioavailability in mouse and rat pharmacokinetic studies via intraperitoneal injection, and also no cytotoxicity against a variety of human cell lines. The Company recently demonstrated a strong synergistic effect with the FDA-approved COVID-19 medicine remdesivir. Additionally, a proof-of-concept animal study demonstrated that daily injection of CDI-45205 exhibited favorable in vivo efficacy in MERS-CoV-2 infected mice. Cocrystal has obtained promising preliminary pharmacokinetic results and is continuing to further evaluate CDI-45205.

“The immediate next steps in the process of advancing this candidate toward clinical development require scale-up synthesis and the subsequent manufacture of several kilograms of the active pharmaceutical ingredient (API) to support Investigational New Drug (IND)-enabling studies and Phase 1 trials,” said Dr. Lee. “Similar to our influenza CC-42344 program, we are exploring multiple routes of administration of preclinical lead molecules including oral, inhalation and injection. We will also be examining in vitro activities of our compounds against the SARS-CoV-2 variants.”

Novel SARS-CoV-2 replication inhibitors

Cocrystal has leveraged its antiviral development expertise by using its proprietary technology and drug discovery platform to launch a second COVID-19 program with additional antiviral compounds developed.

“While we are highly encouraged by preclinical progress with CDI-45205, we continue developing a new class of SARS-CoV inhibitors. We applied our proprietary drug discovery platform technology and high-throughput protein crystallography approach to design new chemical scaffolds to improve in vitro potency and pharmacokinetic properties,” explained Dr. Lee. “Lead discovery and optimization are ongoing. We anticipate identifying another SARS-CoV-2 preclinical lead for oral administration this year. In addition to these two SARS-CoV-2 protease programs, we are also developing novel SARS-CoV-2 inhibitors that block viral replication and transcription. Our goal is to rapidly advance multiple SARS-CoV-2 lead molecules to the clinical trial stage.”

“Public health officials are calling for the urgent development of potent antivirals that inhibit the replication cycle of SARS-CoV-2,” said Gary Wilcox, Ph.D., Chairman and Chief Executive Officer of Cocrystal. “Among the significant challenges scientists face is inhibiting viral replication without damaging the inner workings of healthy cells. Cocrystal’s approach to drug discovery could provide a solution for designing antivirals for use against a range of viruses, including coronaviruses, with limited off-target interaction.

“Our established, proprietary drug discovery platform is comprised of computation, medicinal chemistry and x-ray crystallography together with extensive knowledge of viruses and drug targets. This is a far different approach from traditional, empirical, medicinal chemistry approaches that often require iterative high-throughput compound screening and lengthy hit-to-lead processes,” Dr. Wilcox concluded.

About Cocrystal Pharma, Inc.

Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of coronaviruses (including SARS-CoV-2), influenza viruses, hepatitis C viruses and noroviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create first- and best-in-class antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the future effectiveness of the protease inhibitors, including against new variants of SARS-CoV-2, our expectations regarding the identification of another SARS-CoV-2 preclinical lead for oral administration, and the ability of our approach to drug discovery to yield effective antivirals with limited off-target interaction. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks and uncertainties arising from the impact of the COVID-19 pandemic on the national and global economy and on our Company, including supply chain disruptions and our continued ability to proceed with our programs, including our coronavirus program, our ability to recruit patients into clinical trials, the results of future preclinical and clinical studies, and general risks arising from clinical trials. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2020. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Investor Contact:
LHA Investor Relations
Jody Cain
310-691-7100
jcain@lhai.com

Avivagen Announces Recurring Order for OxC-beta™ Livestock

 

• Largest purchase amount and longest duration purchase to-date
• Four tonne per month order secured
• Order follows five successful OxC-beta™ Livestock commercial trials conducted with various species over the past six months

Ottawa, ON / Business Wire/ May 3, 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 that Meyenberg International Group, Avivagen’s consultant in Mexico, has entered into a contract which secures a four tonne per month recurring order for OxC-beta™ Livestock in Mexico.

The contract, which is 18 months from signing and includes an order for 500 Kgs delivered April 30^th, is a commitment to purchase a minimum of four tonnes monthly, commencing in July, 2021 and ending October, 2022

“As we continue to see successful commercial trials conclude in those jurisdictions where OxC-beta™ Livestock is approved, we anticipate increased demand to follow, as has recently been demonstrated in Mexico and Thailand,” said Kym Anthony, Chief Executive Officer of Avivagen.  “With numerous other commercial trials currently underway and nearing completion, it is our belief that the continued success of such company conducted trials will help to accelerate the adoption and use of OxC-beta™ Livestock in approved jurisdictions and beyond. It is our belief that OxC-beta™ Livestock, once started by a customer, becomes core to their continued operations and will drive recurring orders for years to come.”

Meyenberg International Group
With a client base across North America and a well-earned reputation for enabling rapid growth for clients expanding into LATAM, Meyenberg’s experience in Mexico has enabled Avivagen to quickly establish and grow sales in the country since securing regulatory approval in August 2019.

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.

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.

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 recurring nature of the orders under the contract described above, the anticipated date of fulfillment for the order described,  Avivagen’s expectation that the customer in question will live up to its contractual commitment to purchase product monthly, anticipated increase in demand for Avivagen’s products,  Avivagen’s expectation that commercial trials currently underway will be completed and yield positive results, the anticipated impact of the results of such trials on demand for product, expectations as to the recurring and long term nature of a customer’s purchases once they begin using Avivagen’s products and  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 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 order described may not result in new orders for Avivagen’s products,  the customer plans may change due to many reasons, timing of fulfillment of the order may be delayed beyond current expectation for a number of reasons which would push fulfillment and recognition of revenues for this order into a future quarter or cause such order to be cancelled, the parties to the contract described may not live up to their contractual commitments and/or may agree to amend such contract to reduce the commitments described above, demand for Avivagen’s products may not continue to grow and could decline,  commercial trials may not be completed and, if completed, may not yield results that are positive or which lead to additional demand for Avivagen’s products, except as otherwise stated, customers are under no obligation to continue using Avivagen’s products and Avivagen’s products may not gain market acceptance or regulatory approval in new jurisdictions or for new applications, including human 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

Ocugen announces studies showing COVAXIN potentially effective against three key variants of SARS-CoV-2

 

• COVAXIN effectively neutralizes Brazil variant along with UK variant and India double mutant variant
  
  
• Potential effectiveness against multiple variants reduces the possibility of mutant virus escape
  
  
• According to World Health Organization, the double mutant variant of SARS-CoV-2 has spread to at least 17 countries
  

MALVERN, Pa., May 03, 2021 (GLOBE NEWSWIRE) — Ocugen, Inc. (Nasdaq: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19, today announced that in a new study, scientists at Indian Council of Medical Research (ICMR)-National Institute of Virology have found that COVAXIN demonstrated potential effectiveness against the Brazil variant of SARS-CoV-2, B.1.128.2. As previously disclosed, a study conducted by ICMR also suggested that COVAXIN was effective against the UK variant, B.1.1.7, as well as the Indian double mutant variant, B.1.617. It is notable that the Brazilian variant, B1.128.2, contains the E484K mutation that was found in New York.

In the ICMR studies, COVAXIN-vaccinated sera effectively neutralized several SARS-CoV-2 variants (B.1.617 (India, double mutant), B.1.1.7 (United Kingdom), B.1.1.28 (Brazil P2), and heterologous strain) in an in-vitro plaque reduction neutralization assay. These studies suggest that COVAXIN vaccination may be effective against multiple SARS-CoV-2 variants.

A Media Snippet accompanying this announcement is available by clicking on the image or link below:

“We are pleased to see the results of this study as it demonstrates the potential effectiveness of COVAXIN against multiple variants, further strengthening our belief that this vaccine can potentially eliminate the possibility of mutant virus escape,” said Dr. Satish Chandran, chair of the vaccine scientific advisory board of Ocugen.

“COVAXIN continues to show strong results in all the studies conducted to date. We continue to believe this vaccine is a critical tool to include in our national arsenal to fight this pandemic. The Ocugen team submitted a comprehensive drug master file with the FDA and is currently diligently preparing the EUA application,” said Dr. Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and Co-founder of Ocugen.

Ocugen is developing COVAXIN, Bharat Biotech’s COVID-19 vaccine candidate, for the U.S. market. In the recently shared second interim results of the Phase 3 clinical trial, COVAXIN demonstrated 78% overall efficacy and 100% in severe COVID-19 disease (including hospitalization).

About COVAXIN

COVAXIN, India’s COVID-19 vaccine by Bharat Biotech, is developed in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). COVAXIN is a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform with an excellent safety track record of more than 300 million doses supplied.

In addition to generating strong immune response against multiple antigens, COVAXIN has been shown to generate memory T cell responses, for its multiple epitopes, indicating longevity and a rapid antibody response to future infections. With published data demonstrating a safety profile superior to available data for several other vaccines, COVAXIN is packaged in multi-dose vials that can be stored at 2-8^?C.

About Ocugen, Inc.

Ocugen, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug – “one to many” and our novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. We are co-developing Bharat Biotech’s COVAXIN™ vaccine candidate for COVID-19 in the U.S. market. For more information, please visit www.ocugen.com.

About Bharat Biotech

Bharat Biotech has established an excellent track record of innovation with more than 145 global patents, a wide product portfolio of more than 16 vaccines, 4 bio-therapeutics, registrations in more than 123 countries, and the World Health Organization (WHO) Pre-qualifications. Located in Genome Valley in Hyderabad, India, a hub for the global biotech industry, Bharat Biotech has built a world-class vaccine & bio-therapeutics, research & product development, Bio-Safety Level 3 manufacturing, and vaccine supply and distribution.

Having delivered more than 4 billion doses of vaccines worldwide, Bharat Biotech continues to lead innovation and has developed vaccines for influenza H1N1, Rotavirus, Japanese Encephalitis, Rabies, Chikungunya, Zika, and the world’s first tetanus-toxoid conjugated vaccine for Typhoid. Bharat’s commitment to global social innovation programs and public-private partnerships resulted in introducing path-breaking WHO pre-qualified vaccines BIOPOLIO®, ROTAVAC®, and Typbar TCV® combatting polio, rotavirus, typhoid infections, respectively. The acquisition of the rabies vaccine facility, Chiron Behring, from GlaxoSmithKline (GSK) has positioned Bharat Biotech as the world’s largest rabies vaccine manufacturer. To learn more about Bharat Biotech, visit www.bharatbiotech.com.

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such forward-looking statements include information about qualitative assessments of available data, potential benefits, expectations for clinical trials, and anticipated timing of clinical trial readouts and regulatory submissions. This information involves risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preliminary and interim data (including the Phase 3 interim data), including the possibility of unfavorable new clinical trial data and further analyses of existing clinical trial data; the risk that clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when data from Bharat Biotech’s clinical trials will be published in scientific journal publications and, if so, when and with what modifications; whether the U.S. Food and Drug Administration (FDA) will be satisfied with the design of and results from preclinical and clinical studies of COVAXIN, which have been conducted by Bharat Biotech in India; whether and when any biologics license and/or emergency use authorization applications may be filed in the United States for COVAXIN; whether and when any such applications may be approved by the FDA; decisions by the FDA impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of COVAXIN in the United States, including development of products or therapies by other companies. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release.

Ocugen Contact:
Ocugen, Inc.
Sanjay Subramanian
CFO and Head of Corp. Dev.
IR@Ocugen.com

Media Contact:
LaVoieHealthScience
Lisa DeScenza
ldescenza@lavoiehealthscience.com
+1 9783955970

 

OpRegen® Clinical Data Continues To Demonstrate Improvements In Patients With Dry AMD With Geographic Atrophy

 

• Eighty-Three Percent of All Cohort 4 Patients Exhibited Stable or Improved BCVA
• Visual Acuity Declined in the Majority of Untreated Eyes
• Positive Interim Outcomes on Patient-Reported Visual Function Questionnaire
• No Acute or Delayed Inflammation or Rejection Events, Even in Patients Receiving Reduced Immunosuppressive Regimen
• Previously Reported Evidence of Retinal Restoration Has Persisted to Month 35
• Data Reported at 2021 ARVO Meeting

CARLSBAD, Calif.–(BUSINESS WIRE)–May 3, 2021– 

Lineage Cell Therapeutics, Inc.
 (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, announced today that updated interim results from its ongoing, 24-patient Phase 1/2a clinical study of its lead product candidate, OpRegen, were reported at the 2021 Association for Research in Vision and Ophthalmology Annual Meeting (ARVO 2021). OpRegen is an investigational cell therapy consisting of allogeneic retinal pigment epithelium (RPE) cells administered to the subretinal space for the treatment of dry age-related macular degeneration (AMD) with geographic atrophy (GA). At ARVO 2021, additional data were presented on 24 patients enrolled in the study, including all 12 patients treated in Cohort 4, which have better baseline vision and smaller areas of GA than earlier cohorts.

“I continue to be very excited about this work and the clinical data generated to date with OpRegen, especially in the better vision Cohort 4 patients,” stated Principal Investigator  Christopher D. Riemann, M.D., Vitreoretinal Surgeon and Fellowship Director, 
Cincinnati Eye Institute and 
University of Cincinnati School of Medicine. “There seems to be a significant visual acuity signal in Cohort 4 patients, with most treated eyes having stable or improved vision over time when compared to the contralateral eyes having stable or worsening vision over time. When looking at reading speed progression, treated eyes also seemed to improve while untreated eyes declined. Notably, some individual responders had impressive visual acuity improvements and reductions in GA progression compared to their contralateral eyes. Most importantly, we believe that earlier intervention in less severely affected patients along with a more central placement of transplanted OpRegen cells may increase the likelihood of a clinically beneficial effect. Overall, these results are encouraging and are of a magnitude that could be clinically very important if confirmed in further clinical studies.”

“These new data continue to indicate to us that treatment with OpRegen can generate clinically meaningful outcomes in dry AMD patients with GA, particularly in those with earlier-stage disease,” stated  Brian M. Culley, Lineage CEO. “It also appears that earlier intervention in less severely affected patients and more central placement of the transplanted cells may increase the likelihood of observing a benefit. Additionally, among the newly reported data, it was notable that Cohort 4 patients reported improvements in a majority of the vision parameters measured by a validated quality of life questionnaire. The magnitude of these improvements was higher overall in Cohort 4 than in Cohorts 1 through 3, which is consistent with the larger clinical benefit observed among those patients. As this data set matures, our efforts turn next to evaluating the six most recently treated Cohort 4 patients for indications of retinal restoration and reductions in the size and growth of the areas of GA. Our overall objective is to position OpRegen RPE transplants as the clear leader in the race to address the large unmet need in dry AMD with GA and establish Lineage as the pre-eminent allogeneic cell therapy company.”

Updated results presented at ARVO 2021 included a minimum of 4.5 months of follow-up in all 24 patients treated with OpRegen. Nine of twenty-four patients were treated with the “thaw and inject” formulation of OpRegen, two via a standard pars plana vitrectomy (PPV) and seven utilizing the Orbit™ Subretinal Delivery System (Orbit SDS).

Overall, 10/12 (83%) of the Cohort 4 patients’ treated eyes were at or above baseline visual acuity at their last assessment, based on per protocol scheduled visits ranging from 4.5 months to approximately 3 years post-transplant. Improvements in best corrected visual acuity (BCVA) for Cohort 4 patients reached up to +19 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. In contrast, 10/12 (83%) of the patients’ untreated eyes were below pre-treatment baseline values at the same time points. Among the newly reported data, three (50%) of the more recently treated Cohort 4 patients exhibited marked improvements in BCVA ranging from +7 to +16 letters at their last scheduled assessments of at least 4.5 months. Two additional Cohort 4 patients experienced a gain of 2 letters from their baseline values. One Cohort 4 patient measured 7 letters below baseline. Previously reported structural improvements in the retina, decreases in drusen density, and a trend toward slower GA progression in treated compared to untreated eyes continued. Overall, OpRegen has been well tolerated with no unexpected adverse events or serious adverse events, and evidence of durable engraftment of OpRegen RPE cells have extended to more than 5 years in earliest treated patients, supporting the potential for OpRegen to be a one-time treatment.

A Cohort 4 patient with evidence of retinal restoration and confirmed history of GA growth, which was first reported 9 months following treatment, continues to demonstrate areas of retinal restoration as of their last assessment, approximately 3 years after treatment.

2021 ARVO Presentation OpRegen Data Highlights (As of April 16, 2021):

• In Cohort 1-3 patients (all legally blind at baseline), visual acuity reductions occurred as expected due to progressive GA;
• In Cohort 4 patients, which collectively had smaller areas of GA and higher baseline BCVA as compared to Cohort 1-3 patients, improved or sustained BCVA has been observed in 10/12 (83%) patients as of their last visit prior to this update (range of -7 to +19 letters on the ETDRS chart);
• OpRegen continues to be well-tolerated in all treated patients (N = 24);
• The majority of adverse events were mild (87%);
• Sustained subretinal pigmentation continues to suggest multi-year durability of OpRegen transplants;
• Improved anatomy and function continue to be observed in some patients, including:
  • Reduction in drusen;
  • Photoreceptor and RPE layer restoration;
  • Localized slowing of GA progression in treated areas;
  • Better visual acuity via ETDRS scores and reading speed; and
  • Improved National Eye Institute Visual Function Questionnaire (VFQ-25) scores.
• Post-treatment surgical interventions occurred in four cases (5 events in 4 patients):
  • Three epiretinal membranes (ERM) were surgically peeled. Mild to moderate ERM were observed in an additional 12 out of 17 PPV operated patients. Most ERMs were clinically insignificant.
  • Retinal detachment (RD) was observed in 2 out of 17 patients, neither of which appears to be attributable to OpRegen or any study related medications:
    • The first case of RD, which occurred in a Cohort 3 patient, was an unsuccessful repair of a post-surgical retinal tear; visual acuity did not regain baseline levels; and
    • The second case of RD, which occurred in a Cohort 4 patient, was successfully repaired; post-surgical visual acuity has remained higher than baseline.
• Choroidal neovascularization (CNV) was observed in 3 out of 7 patients receiving OpRegen via the Orbit SDS, all of whom received treatment with an approved anti-VEGF;
• As previously reported, one PPV operated patient developed CNV, which was identified more than two years following treatment.

As part of an ongoing effort to administer the minimally effective dose and duration of immunosuppressive therapy, immunosuppression was utilized only during the perioperative period of approximately 3 months in Cohort 4 patients. One patient received a modified immunosuppressive regimen at baseline, which included no tacrolimus and only mycophenolate mofetil. One patient was diagnosed with COVID-19 shortly after treatment for whom all immunosuppression was halted and reinstated once the patient was asymptomatic. Both patients showed no signs of acute or delayed inflammation or rejection of OpRegen cells with 4.5 months of post-transplant follow up. Other than the reduced regimens described above, immunosuppressants have been discontinued as scheduled, typically within 90 days post-operatively, and no cases of acute or delayed rejection or inflammation due to OpRegen have been reported in any patients treated with OpRegen.

The presentation, “Phase I/IIa Clinical Trial of Transplanted Allogeneic Retinal Pigmented Epithelium (RPE, OpRegen) Cells in Advanced Dry Age-Related Macular Degeneration (AMD): Interim Results” is being featured as part of the Stem Cells/Gene Therapy/Transplantation Session, on 
May 6, 2021 
between 5:15 pm and 6:45 pm EDT by 
Christopher D. Riemann, M.D.(abstract number 3538173).

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 (vision from 20/65 to 20/250 with smaller 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. Additional objectives include the evaluation of the safety of delivery of OpRegen using the Orbit SDS. OpRegen is a registered trademark of 
Cell Cure Neurosciences Ltd., a majority-owned subsidiary of 
Lineage Cell Therapeutics, Inc. The Orbit subretinal delivery system is used under agreement with 
Gyroscope Therapeutics Limited. Orbit and Orbit SDS are trademarks of 
Gyroscope Therapeutics Limited.

About Dry AMD

Dry age-related macular degeneration (AMD) is a leading cause of adult blindness in the developed world. There are two forms of AMD: wet AMD and dry AMD. Dry AMD is the more common of the two types, accounting for approximately 85-90% of cases. Wet AMD is the less common of the two types, accounting for approximately 10-15% of cases. Global sales of the two leading wet AMD therapies were in excess of 
$10 billion in 2019. Nearly all cases of wet AMD begin as dry AMD. Dry AMD typically affects both eyes. There are currently no 
U.S. Food and Drug Administration or 
European Medicines Agency approved treatment options available for patients with dry 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) 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.

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,” “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 expected clinical outcomes of treatment with OpRegen in dry AMD patients with GA. 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 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
Gitanjali Jain Ogawa
(Gogawa@soleburytrout.com)
(646) 378-2949

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

Source: 
Lineage Cell Therapeutics, Inc.

Ocugen Inc. Announces Closing of $100 Million Registered Direct Offering of Common Stock Priced at a Premium to Market

 

MALVERN, Pa., April 28, 2021 (GLOBE NEWSWIRE) — Ocugen, Inc. (Nasdaq: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19, today announced that it has closed the previously announced registered direct offering with healthcare-focused institutional investors for the sale of an aggregate of 10 million shares of its common stock at a purchase price of $10 per share.

H.C. Wainwright & Co. acted as the exclusive placement agent for the offering. Roth Capital Partners acted as financial advisor to Ocugen.

The gross proceeds of the offering were approximately $100 million, prior to deducting placement agent’s fees and other offering expenses payable by Ocugen. Ocugen intends to use the net proceeds from the offering for general corporate purposes, capital expenditures, working capital and general and administrative expenses.

The shares of common stock described above were offered pursuant to an automatic “shelf” registration statement (File No. 333-254550) filed with the Securities and Exchange Commission (“SEC”) on March 22, 2021 which automatically became effective pursuant to SEC rules. Such shares of common stock were offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and the accompanying prospectus relating to the offering of the shares of common stock was filed with the SEC. Electronic copies of the final prospectus supplement and the accompanying prospectus relating to the offering of the shares of common stock may be obtained on the SEC’s website at http://www.sec.gov or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by e-mail: placements@hcwco.com or by telephone: (646) 975-6996.

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

About Ocugen, Inc.

Ocugen, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug – “one to many,” and our novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. We are co-developing Bharat Biotech’s COVAXIN™ vaccine candidate for COVID-19 in the U.S. market. For more information, please visit www.ocugen.com.

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. Such forward-looking statements within this press release include, without limitation, the intended use of net proceeds from the registered direct offering. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from our current expectations, such as market and other conditions. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (the “SEC”), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release.

Ocugen Contact:
Ocugen, Inc.
Sanjay Subramanian
CFO and Head of Corp. Dev.
IR@Ocugen.com

Media Contact:
LaVoieHealthScience
Lisa DeScenza
ldescenza@lavoiehealthscience.com
+1 9783955970

Ocugen Inc. Announces Closing of $100 Million Registered Direct Offering of Common Stock Priced at a Premium to Market

 

MALVERN, Pa., April 28, 2021 (GLOBE NEWSWIRE) — Ocugen, Inc. (Nasdaq: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19, today announced that it has closed the previously announced registered direct offering with healthcare-focused institutional investors for the sale of an aggregate of 10 million shares of its common stock at a purchase price of $10 per share.

H.C. Wainwright & Co. acted as the exclusive placement agent for the offering. Roth Capital Partners acted as financial advisor to Ocugen.

The gross proceeds of the offering were approximately $100 million, prior to deducting placement agent’s fees and other offering expenses payable by Ocugen. Ocugen intends to use the net proceeds from the offering for general corporate purposes, capital expenditures, working capital and general and administrative expenses.

The shares of common stock described above were offered pursuant to an automatic “shelf” registration statement (File No. 333-254550) filed with the Securities and Exchange Commission (“SEC”) on March 22, 2021 which automatically became effective pursuant to SEC rules. Such shares of common stock were offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and the accompanying prospectus relating to the offering of the shares of common stock was filed with the SEC. Electronic copies of the final prospectus supplement and the accompanying prospectus relating to the offering of the shares of common stock may be obtained on the SEC’s website at http://www.sec.gov or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by e-mail: placements@hcwco.com or by telephone: (646) 975-6996.

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

About Ocugen, Inc.

Ocugen, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug – “one to many,” and our novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. We are co-developing Bharat Biotech’s COVAXIN™ vaccine candidate for COVID-19 in the U.S. market. For more information, please visit www.ocugen.com.

Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. Such forward-looking statements within this press release include, without limitation, the intended use of net proceeds from the registered direct offering. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from our current expectations, such as market and other conditions. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (the “SEC”), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release.

Ocugen Contact:
Ocugen, Inc.
Sanjay Subramanian
CFO and Head of Corp. Dev.
IR@Ocugen.com

Media Contact:
LaVoieHealthScience
Lisa DeScenza
ldescenza@lavoiehealthscience.com
+1 9783955970

Avivagen Announces First Purchase Order from Large Integrated Producer in Asia

 

Ottawa, ON / Business Wire/ April 26, 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 food production and supports immune function, thereby supporting general health and performance, is pleased to announce it has received its first purchase order from a large, integrated livestock producer in Thailand. The customer is a very large, well-known and respected swine and poultry producer in the region. This first purchase order from this customer, while modest in size, comes on the heels of several trials conducted by the customer with sows and piglets over the last nine months, whereby Avivagen’s OxC-beta^TM Livestock consistently outperformed any and all competitive alternatives.

“We are very excited about this purchase from a very large and established market leading livestock producer in Thailand,” said Kym Anthony, Avivagen’s CEO.  “It is our belief that this first purchase, similar to our experience with UNAHCO, will lead to a growing rollout over the coming quarters and years by the customer and is likely to influence other producers in the region to adopt our product. The real world evidence of the benefits of our product are leading to more customer wins and growing adoption of our OxC-beta™ Livestock product.”

With annual livestock feed production in 2020 of 21million tonnes[i] Thailand is an important market opportunity for Avivagen, not only due to its size but the fact that Thailand’s largest livestock export market remains the European Union, where AGPs (Antibiotics as Growth Promoters) have been banned since 2010

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.

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.

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 future delivery of product based on the purchase order received, Avivagen’s expectations as to growth of its branding in certain jurisdictions, continued distribution and acceptance of Avivagen’s technology, anticipated 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 order described may not result in new orders for Avivagen’s products,  the customer plans may change due to many reasons 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,  and fulfillment of the order may be delayed beyond current expectation, or in the worst case cancelled, 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

electroCore, Inc. Announces Johns Hopkins University School of Medicine Study of Non-Invasive Vagus Nerve Stimulation (nVNS) for Symptomatic Exacerbation of Nausea in Patients with Gastroparesis and Related Disorders

 

ROCKAWAY, NJ, 
April 26, 2021 (GLOBE NEWSWIRE) —  — 
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced that 
Johns Hopkins University School of Medicine is starting an investigator-initiated trial of non-invasive vagus nerve stimulation (nVNS) using the Company’s proprietary gammaCore device to treat symptomatic exacerbation of nausea in patients with gastroparesis and related disorders (NCT04857281).

Many gastrointestinal disorders can cause nausea and vomiting, of which the most well-known is gastroparesis, a digestive disorder in which the stomach empties slowly.¹ The symptoms of gastroparesis can range from mild to severe, requiring prolonged hospitalizations and interventions, and causing life-threatening complications which can significantly affect the quality of life in affected individuals. It is estimated that close to 6 million Americans suffer from gastroparesis which is more common in women than men.² The economic impact of gastroparesis can be substantial, with studies reporting 11% of patients disabled due to their gastroparesis symptoms, while another 28.5% reported a loss of yearly income. ³

Nausea without slow gastric emptying may be even more common and has been referred to by many names, including chronic unexplained nausea and vomiting (CUNV), gastroparesis-like syndrome (GLS), functional vomiting, and vomiting of unexplained etiology (VUE). Many of these patients can be classified as having functional dyspepsia (FD) which is a disorder that may affect 10% of the US population.⁴

“The vagus nerve plays a key role in the regulation of nausea and vomiting,” commented Dr. Jay Pasricha, Professor of Medicine and Neurosciences and Director of the 
Johns Hopkins Center for Neurogastroenterology and principal investigator of the study. “Vagal modulation is currently thought to be a major component of the treatment benefit from an implanted gastric electrical stimulation (GES) device in patients with symptoms of gastroparesis and the planned proof of concept study explores whether a non-invasive hand-held device for vagal modulation can also be effective in reducing the need for traditional rescue medications for patients with unexplained nausea and vomiting.”

“We appreciate  Dr. Pasricha and his team selecting gammaCore (nVNS) for their study,” said  Eric Liebler, Senior Vice President of Neurology at electroCore, Inc. “gammaCore (nVNS) is the first non-invasive, handheld medical device proven to activate the vagus nerve by providing a patented mild electrical stimulation through the skin, and offers a potential alternative to GES that could eliminate significant risks of injury or illness associated with implantation.”

For more information, visit clinicaltrials.gov.

About electroCore, Inc.

electroCore, Inc. is a commercial stage bioelectronic medicine company dedicated to improving patient outcomes through its platform non-invasive vagus nerve stimulation therapy initially focused on the treatment of multiple conditions in neurology. The company’s current indications are for the preventative treatment of cluster headache and migraine and acute treatment of migraine and episodic cluster headache.

For more information, visit www.electrocore.com.

About gammaCore^TM

gammaCore^TM (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck as an adjunctive therapy to treat migraine and cluster headache through the utilization of a mild electrical stimulation to the vagus nerve that passes through the skin. Designed as a portable, easy-to-use technology, gammaCore can be self-administered by patients, as needed, without the potential side effects associated with commonly prescribed drugs. When placed on a patient’s neck over the vagus nerve, gammaCore stimulates the nerve’s afferent fibers, which may lead to a reduction of pain in patients.

gammaCore is FDA cleared in the United States for adjunctive use for the preventive treatment of cluster headache in adult patients, the acute treatment of pain associated with episodic cluster headache in adult patients, and the acute and preventive treatment of migraine in adolescent (ages 12 and older) and adult patients. gammaCore is CE-marked in the European Union for the acute and/or prophylactic treatment of primary headache (Migraine, Cluster Headache, Trigeminal Autonomic Cephalalgias and Hemicrania Continua) and Medication Overuse Headache in adults.

• gammaCore is contraindicated for patients with:
  • An active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
  • A metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck
  • An open wound, rash, infection, swelling, cut, sore, drug patch, or surgical scar(s) on the neck at the treatment location
• Safety and efficacy of gammaCore have not been evaluated in the following patients:
  • Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
  • Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
  • Pediatric
  • Patients (younger than 12 years)
  • Pregnant women
  • Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia
    
    

Please refer to the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product.

Forward-Looking Statements

This press release and other written and oral statements made by representatives of electroCore may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about electroCore’s business prospects and clinical and product development plans; its pipeline or potential markets for its technologies; the timing, outcome and impact of regulatory, clinical and commercial developments; the availability and impact of payer coverage, the potential of nVNS generally and gammaCore in particular to treat symptomatic exacerbation of nausea in patients with gastroparesis and related disorders and other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “believes,” “intends,” other words of similar meaning, derivations of such words and the use of future dates. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to raise the additional funding needed to continue to pursue electroCore’s business and product development plans, the inherent uncertainties associated with developing new products or technologies, the ability to commercialize gammaCore™, the potential impact and effects of COVID-19 on the business of electroCore, electroCore’s results of operations and financial performance, and any measures electroCore has and may take in response to COVID-19 and any expectations electroCore may have with respect thereto, competition in the industry in which electroCore operates and overall market conditions. Any forward-looking statements are made as of the date of this press release, and electroCore assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents electroCore files with the 
SEC available at www.sec.gov.

¹ Camilleri, M; Parkman HP; Shafi MA; Abell T; Gerson L. Clinical guideline: management of gastroparesis. 2013 Jan; 108 (1): 18-37.
² Rey E, Choung RS, Schleck CD, Zinsmeister AR, Talley NJ, Locke GR III. Prevalence of hidden gastroparesis in the community: the gastroparesis“iceberg”. J Neurogastroenterol Motil. 2012;18:34–42.
³ Lacy BE, Crowell MD, Mathis C, Bauer D, Heinberg LJ. Gastroparesis: quality of life and health care utilization. J Clin Gastroenterol. 2018; 52: 20–24.
⁴ Harer, K; Pasricha PJ. Chronic Unexplained Nausea and Vomiting or Gastric Neuromuscular Dysfunction (GND) An Update on Nomenclature, Pathophysiology and Treatment and Relationship to Gastroparesis. 2016 Dec; 14 (4): 410-419.

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

or

Media Contact:
Summer Diaz
electroCore
816-401-6333
summer.diaz@electrocore.com

electroCore, Inc. Announces Johns Hopkins University School of Medicine Study of Non-Invasive Vagus Nerve Stimulation (nVNS) for Symptomatic Exacerbation of Nausea in Patients with Gastroparesis and Related Disorders

 

ROCKAWAY, NJ, 
April 26, 2021 (GLOBE NEWSWIRE) —  — 
electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced that 
Johns Hopkins University School of Medicine is starting an investigator-initiated trial of non-invasive vagus nerve stimulation (nVNS) using the Company’s proprietary gammaCore device to treat symptomatic exacerbation of nausea in patients with gastroparesis and related disorders (NCT04857281).

Many gastrointestinal disorders can cause nausea and vomiting, of which the most well-known is gastroparesis, a digestive disorder in which the stomach empties slowly.¹ The symptoms of gastroparesis can range from mild to severe, requiring prolonged hospitalizations and interventions, and causing life-threatening complications which can significantly affect the quality of life in affected individuals. It is estimated that close to 6 million Americans suffer from gastroparesis which is more common in women than men.² The economic impact of gastroparesis can be substantial, with studies reporting 11% of patients disabled due to their gastroparesis symptoms, while another 28.5% reported a loss of yearly income. ³

Nausea without slow gastric emptying may be even more common and has been referred to by many names, including chronic unexplained nausea and vomiting (CUNV), gastroparesis-like syndrome (GLS), functional vomiting, and vomiting of unexplained etiology (VUE). Many of these patients can be classified as having functional dyspepsia (FD) which is a disorder that may affect 10% of the US population.⁴

“The vagus nerve plays a key role in the regulation of nausea and vomiting,” commented Dr. Jay Pasricha, Professor of Medicine and Neurosciences and Director of the 
Johns Hopkins Center for Neurogastroenterology and principal investigator of the study. “Vagal modulation is currently thought to be a major component of the treatment benefit from an implanted gastric electrical stimulation (GES) device in patients with symptoms of gastroparesis and the planned proof of concept study explores whether a non-invasive hand-held device for vagal modulation can also be effective in reducing the need for traditional rescue medications for patients with unexplained nausea and vomiting.”

“We appreciate  Dr. Pasricha and his team selecting gammaCore (nVNS) for their study,” said  Eric Liebler, Senior Vice President of Neurology at electroCore, Inc. “gammaCore (nVNS) is the first non-invasive, handheld medical device proven to activate the vagus nerve by providing a patented mild electrical stimulation through the skin, and offers a potential alternative to GES that could eliminate significant risks of injury or illness associated with implantation.”

For more information, visit clinicaltrials.gov.

About electroCore, Inc.

electroCore, Inc. is a commercial stage bioelectronic medicine company dedicated to improving patient outcomes through its platform non-invasive vagus nerve stimulation therapy initially focused on the treatment of multiple conditions in neurology. The company’s current indications are for the preventative treatment of cluster headache and migraine and acute treatment of migraine and episodic cluster headache.

For more information, visit www.electrocore.com.

About gammaCore^TM

gammaCore^TM (nVNS) is the first non-invasive, hand-held medical therapy applied at the neck as an adjunctive therapy to treat migraine and cluster headache through the utilization of a mild electrical stimulation to the vagus nerve that passes through the skin. Designed as a portable, easy-to-use technology, gammaCore can be self-administered by patients, as needed, without the potential side effects associated with commonly prescribed drugs. When placed on a patient’s neck over the vagus nerve, gammaCore stimulates the nerve’s afferent fibers, which may lead to a reduction of pain in patients.

gammaCore is FDA cleared in the United States for adjunctive use for the preventive treatment of cluster headache in adult patients, the acute treatment of pain associated with episodic cluster headache in adult patients, and the acute and preventive treatment of migraine in adolescent (ages 12 and older) and adult patients. gammaCore is CE-marked in the European Union for the acute and/or prophylactic treatment of primary headache (Migraine, Cluster Headache, Trigeminal Autonomic Cephalalgias and Hemicrania Continua) and Medication Overuse Headache in adults.

• gammaCore is contraindicated for patients with:
  • An active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device
  • A metallic device, such as a stent, bone plate, or bone screw, implanted at or near the neck
  • An open wound, rash, infection, swelling, cut, sore, drug patch, or surgical scar(s) on the neck at the treatment location
• Safety and efficacy of gammaCore have not been evaluated in the following patients:
  • Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
  • Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
  • Pediatric
  • Patients (younger than 12 years)
  • Pregnant women
  • Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia
    
    

Please refer to the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product.

Forward-Looking Statements

This press release and other written and oral statements made by representatives of electroCore may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about electroCore’s business prospects and clinical and product development plans; its pipeline or potential markets for its technologies; the timing, outcome and impact of regulatory, clinical and commercial developments; the availability and impact of payer coverage, the potential of nVNS generally and gammaCore in particular to treat symptomatic exacerbation of nausea in patients with gastroparesis and related disorders and other statements that are not historical in nature, particularly those that utilize terminology such as “anticipates,” “will,” “expects,” “believes,” “intends,” other words of similar meaning, derivations of such words and the use of future dates. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to raise the additional funding needed to continue to pursue electroCore’s business and product development plans, the inherent uncertainties associated with developing new products or technologies, the ability to commercialize gammaCore™, the potential impact and effects of COVID-19 on the business of electroCore, electroCore’s results of operations and financial performance, and any measures electroCore has and may take in response to COVID-19 and any expectations electroCore may have with respect thereto, competition in the industry in which electroCore operates and overall market conditions. Any forward-looking statements are made as of the date of this press release, and electroCore assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents electroCore files with the 
SEC available at www.sec.gov.

¹ Camilleri, M; Parkman HP; Shafi MA; Abell T; Gerson L. Clinical guideline: management of gastroparesis. 2013 Jan; 108 (1): 18-37.
² Rey E, Choung RS, Schleck CD, Zinsmeister AR, Talley NJ, Locke GR III. Prevalence of hidden gastroparesis in the community: the gastroparesis“iceberg”. J Neurogastroenterol Motil. 2012;18:34–42.
³ Lacy BE, Crowell MD, Mathis C, Bauer D, Heinberg LJ. Gastroparesis: quality of life and health care utilization. J Clin Gastroenterol. 2018; 52: 20–24.
⁴ Harer, K; Pasricha PJ. Chronic Unexplained Nausea and Vomiting or Gastric Neuromuscular Dysfunction (GND) An Update on Nomenclature, Pathophysiology and Treatment and Relationship to Gastroparesis. 2016 Dec; 14 (4): 410-419.

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

or

Media Contact:
Summer Diaz
electroCore
816-401-6333
summer.diaz@electrocore.com

Avivagen Announces First Purchase Order from Large Integrated Producer in Asia

 

Ottawa, ON / Business Wire/ April 26, 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 food production and supports immune function, thereby supporting general health and performance, is pleased to announce it has received its first purchase order from a large, integrated livestock producer in Thailand. The customer is a very large, well-known and respected swine and poultry producer in the region. This first purchase order from this customer, while modest in size, comes on the heels of several trials conducted by the customer with sows and piglets over the last nine months, whereby Avivagen’s OxC-beta^TM Livestock consistently outperformed any and all competitive alternatives.

“We are very excited about this purchase from a very large and established market leading livestock producer in Thailand,” said Kym Anthony, Avivagen’s CEO.  “It is our belief that this first purchase, similar to our experience with UNAHCO, will lead to a growing rollout over the coming quarters and years by the customer and is likely to influence other producers in the region to adopt our product. The real world evidence of the benefits of our product are leading to more customer wins and growing adoption of our OxC-beta™ Livestock product.”

With annual livestock feed production in 2020 of 21million tonnes[i] Thailand is an important market opportunity for Avivagen, not only due to its size but the fact that Thailand’s largest livestock export market remains the European Union, where AGPs (Antibiotics as Growth Promoters) have been banned since 2010

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.

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.

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 future delivery of product based on the purchase order received, Avivagen’s expectations as to growth of its branding in certain jurisdictions, continued distribution and acceptance of Avivagen’s technology, anticipated 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 order described may not result in new orders for Avivagen’s products,  the customer plans may change due to many reasons 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,  and fulfillment of the order may be delayed beyond current expectation, or in the worst case cancelled, 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

Monday, April 26, 2021

Avivagen Inc. (VIVXF)(VIV:CA)
Receives Largest Single Purchase Order

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.

Order. On Friday, Avivagen announced it had received a purchase order for a single shipment of 4.4 metric tonnes of OxC-beta Livestock. This represents the largest single shipment purchase order of OxC-beta to date and represents a 10% increase in size over the previous record single shipment order. This one order represents more than 40% of the previous year’s total volume. The order continues the momentum seen by Avivagen in the acceptance of OxC-beta as an alternative to antibiotics in animal feed, in our view.


UNAHCO.  Friday’s order was placed by UNAHCO, one of the earliest adopters of OxC-beta. Since UNAHCO’s first order in November 2016 of 150 kilograms for use in swine feed, UNAHCO’s demand for the product has grown significantly. In April 2020, UNAHCO placed a three tonne order, which was 50% larger than any previous order, only to top that with a four tonne order In October of last year. Including …

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.