Release – Lineage Cell Therapeutics (LCTX) – Enters Into Exclusive Agreement With Neurgain Technologies To Evaluate Novel Delivery System For OPC1

 


Lineage Enters Into Exclusive Agreement With Neurgain Technologies To Evaluate Novel Delivery System For OPC1 To Treat Spinal Cord Injury

 

Use of the Neurgain PDI system could support later-stage trials of OPC1 in cervical injury patients
OPC1 Investor & Analyst Day planned for February 22, 2021

CARLSBAD, Calif.–(BUSINESS WIRE)–Feb. 8, 2021– Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today announced that it has entered into an exclusive option and license agreement with Neurgain Technologies, Inc. (“Neurgain”), a medical device company that is commercializing technology developed by neurosurgeons at the University of California San Diego (“UC San Diego”). Under the terms of the agreement, Lineage and Neurgain will collaborate on the clinical testing of Neurgain’s novel Parenchymal Delivery Injection (“PDI”) system, which is designed to allow for the administration of cells to the spinal cord without stopping the patient’s respiration. Elimination of the need to stop respiration during surgery is expected to reduce the complexity, risk, and variability of administering cells to the area of injury. Lineage also will be hosting an OPC1 Investor and Analyst Day on February 22, 2021 to provide details on recent OPC1 milestones and plans for 2021.

Lineage will evaluate the Neurgain PDI system’s ability to safely and effectively deliver OPC1, Lineage’s allogeneic oligodendrocyte progenitor cell (OPC) transplant, to the spinal cord in both preclinical and clinical studies beginning this year. If results from the PDI system are positive, then Lineage may exercise its option to enter into a pre-negotiated license and commercialization agreement with Neurgain. Pursuant to that agreement, Lineage may integrate the PDI system into a later-stage clinical trial and if approved, commercial use of OPC1 for the treatment of patients with a cervical spinal cord injury. There currently are no U.S. Food and Drug Administration (“FDA”) approved treatments for spinal cord injury.

Brian M. Culley, Lineage CEO stated, “Several months ago, we announced we had significantly improved the process for manufacturing OPC1, leading to large increases in purity and scale. More recently, we successfully developed a new ‘thaw-and-inject’ formulation, eliminating the commercially undesirable steps of handling and preparing cells one day prior to their use. Today, we are announcing another valuable improvement to the OPC1 program: access to a novel and convenient delivery system, which reduces a significant technical hurdle of conducting a larger-scale clinical trial. The Neurgain PDI offers an easier, potentially safer, and commercially more attractive option to treat SCI patients and is preferable to the complicated gantry utilized in an earlier study. It also will allow us to incorporate our new ‘thaw-and-inject’ formulation of OPC1, thereby enabling faster patient enrollment via access to a larger number of clinical trial sites. Most importantly, the PDI can eliminate the need for a patient’s respirator to be turned off during the procedure, facilitating a measured and targeted transplantation of cells to the affected area.”

“We look forward to collaborating with Lineage on their novel OPC1 program and demonstrating the value that Neurgain’s PDI system can provide for the effective delivery of cell therapies in general and for the treatment of spinal cord injury in particular,” stated Michael Krupp, Neurgain CEO.

Brian Culley added, “Similar to our alliance with Gyroscope Therapeutics for the Orbit Subretinal Delivery System, this new partnership with Neurgain delivers on our stated commitment to identifying and deploying optimal combinations of allogeneic cell therapies, modern manufacturing techniques, and superior delivery solutions in pursuit of our goal of becoming the pre-eminent allogeneic cell transplant company.”

The Neurgain PDI System has been designed to provide specific, on-target delivery of cells with accurate dosing. The PDI system is more compact than existing devices and it is attached directly to the patient during the procedure. It is comprised of a platform and manipulator with a disposable magnetic needle assembly. This novel delivery system is expected to provide a significant improvement in usability and precision when compared to the methods and tools utilized to deliver OPC1 cells in the completed phase 1/2a SCiStar study of OPC1 for the treatment of acute cervical SCI.

About Spinal Cord Injuries

A spinal cord injury (SCI) occurs when the spinal cord is subjected to a severe crush or contusion and frequently results in severe functional impairment, including limb paralysis, aberrant pain signaling, and loss of bladder control and other body functions. There are approximately 18,000 new spinal cord injuries annually in the U.S. There are no FDA-approved drugs specifically for the treatment of SCI. The cost of a lifetime of care for a severe spinal cord injury can be as high as $5 million.

About OPC1

OPC1 is an oligodendrocyte progenitor cell (OPC) transplant therapy designed to provide clinically meaningful improvements in motor recovery in individuals with acute spinal cord injuries (SCI). OPCs are naturally occurring precursors to the cells which provide electrical insulation for nerve axons in the form of a myelin sheath. The OPC1 program has been partially funded by a $14.3 million grant from the California Institute for Regenerative Medicine (CIRM). OPC1 has received Regenerative Medicine Advanced Therapy (RMAT) designation and Orphan Drug designation from the FDA.

About the OPC1 Clinical Study

The “SCiStar” Study of OPC1 is an open-label, 25-patient, single-arm trial testing three sequential escalating doses of OPC1 administered 21 to 42 days post-injury in patients with subacute motor complete (AIS-A or AIS-B) cervical (C-4 to C-7) acute spinal cord injuries (SCI). Patient enrollment in this study is complete; 96% of patients reported one level of improved motor function and 33% of patients reported two levels of improved motor function. Patients continue to be evaluated on a long-term basis. Patients enrolled in the study had experienced severe paralysis of the upper and lower limbs. The primary endpoint in the study was safety. Secondary outcome measures included neurological function measured by upper extremity motor scores (UEMS) and motor level on International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) examinations through 365 days post-treatment.

About Neurgain Technologies, Inc.

Neurgain Technologies (NGT) was founded in 2013 to develop technologies focused on the treatment of neurodegenerative diseases and neuropathic pain. Neurgain is developing a novel gene therapy technology and delivery devices to treat chronic neuropathic pain and spinal spasticity. 7-8% of the population suffers from Neuropathic Pain. Current therapeutic management is not working: Drugs in use have poor efficacy, and cause undesirable side effects such as resistance, addiction, and other disorders. NGT’s mission is to positively impact this problem by means of our patented innovation to provide a therapy that works and improves the patient’s quality of life. The Company is developing two assets: 1. Spinal subpial gene delivery platform (device), 2. Pre-clinical gene therapy for severe neuropathic pain. NGT plans to license the platform delivery technologies to multiple pharma/biotech which are developing gene or cell therapies in CNS. Neurgain’s business strategy involves the out-licensing of spinal cord delivery technology and clinical development of a gene therapy for neuropathic pain and chronic spasticity. For more information, please visit https://neurgaintech.com/.

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 Lineage’s expected eligibility for grants. 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 (the 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 Annual Report on Form 10-K filed with the SEC on March 12, 2020 and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

Lineage Cell Therapeutics, Inc. IR
Ioana C. Hone
([email protected])
(442) 287-8963

Solebury Trout IR
Gitanjali Jain Ogawa
([email protected])
(646) 378-2949

Russo Partners – Media Relations
Nic Johnson or David Schull
[email protected]
[email protected]
(212) 845-4242

Source: Lineage Cell Therapeutics, Inc.

PDS Biotechnology Corp (PDSB) – NCI-sponsored Phase 2 Study will Progress to Full Enrollment

Thursday, February 04, 2021

PDS Biotechnology Corp (PDSB)
NCI-sponsored Phase 2 Study will Progress to Full Enrollment

PDS Biotechnology Corp operates as a clinical stage biotechnology company, principally involved in drug discovery in the United States. It is primarily engaged in the treatment of various early-stage and late-stage cancers, including head and neck cancer, prostate cancer, breast cancer, cervical cancer, anal cancer, and other cancers. Its products are based on the proprietary Versamune platform technology, which activates and directs the human immune system to unleash a powerful and targeted attack against cancer cells.

Ahu Demir, Ph. D., Biotechnology Research Analyst, Noble Capital Markets, Inc.

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

    Moving towards full enrollment based on preliminary efficacy. Yesterday, PDS Biotechnology announced achievement of preliminary efficacy leading to progression of Phase 2 study to full enrollment. The National Cancer Institute’s (NCI) sponsored Phase 2 trial is evaluating PDS0101 in combination with two investigational immune-modulating agents bintrafusp alfa (M7824, a TGF-b / anti-PD-L1 bifunctional fusion protein) and NHS-IL12 (M9241, a DNA-targeted immunocytokine) for the treatment of advanced human papillomavirus (HPV)-associated cancers. Trial progression was decided initially based on the safety profile of the triple combination. Then on the efficacy front, the triple combination was expected to exceed (~40%) the single-agent M7824 clinical efficacy (30.5% objective response rate, ORR, published on J ImmunoTher Cancer 2020 October). As the objective response was observed in 3 out of 8 patients (37.5% ORR), the Phase 2 study will progress to full enrollment.

    Phase 2 study details.  The Phase 2 clinical study (NCT04287868) evaluating triple combination (M7824, M9241, and PDS0101 in a total of 40 subjects who are checkpoint inhibitor naïve and refractory patients with HPV-associated cancers. We anticipate more mature data in Q2/Q3 2021 …



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

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

Release – Ocugen (OCGN) – Announces Execution of Definitive Agreement for the Commercialization of COVAXIN


Ocugen and Bharat Biotech Announce Execution of Definitive Agreement for the Commercialization of COVAXIN™ in the US Market

 

  • Definitive Agreement provides details of the previously announced intent to co-develop COVAXIN™ for the US market
  • Ocugen and Bharat Biotech to share US commercialization profits
  • Ocugen to receive initial supply of COVAXIN™ doses from Bharat Biotech upon authorization from US regulatory authorities while it ramps up manufacturing in the US
  • COVAXIN™ received EUA (Emergency Use Authorization) in India in January and is currently in a fully enrolled Phase 3 clinical trial involving 25,800 patients
  • COVAXIN™ (whole-virion inactivated COVID-19 vaccine candidate) effectively neutralizes UK variant of SARS-Cov-2 reducing the possibility of mutant virus escape

MALVERN, Pa. and HYDERABAD, India, Feb. 02, 2021 — Ocugen, Inc., (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to fight COVID-19, and Bharat Biotech, a global leader in vaccine innovation, today announced they have entered into a definitive agreement to co-develop, supply, and commercialize Bharat Biotech’s COVAXIN™, an advanced stage whole-virion inactivated COVID-19 vaccine candidate, for the United States market.

Under the terms of the agreement, Ocugen will have US rights to the vaccine candidate and will be responsible for clinical development, regulatory approval (including EUA) and commercialization for the US market. Bharat Biotech will supply initial doses to be used in the US upon Ocugen’s receipt of an EUA. In addition, Bharat Biotech will support the technology transfer for manufacturing in the US. In consideration for the exclusive license to the US market, Ocugen will share the profits from the sale of COVAXIN™ in the US market with Bharat Biotech, with Ocugen retaining 45% of the profits.

The collaboration will leverage the vaccine expertise of Ocugen’s leadership team. In preparation for the development of COVAXIN™ in the US, Ocugen’s Vaccine Scientific Advisory Board and Ocugen management have initiated discussions with the U.S. Food & Drug Administration (FDA) and the Biomedical Advanced Research and Development Authority (BARDA) to develop a regulatory path to EUA and, eventually, biologics license application (BLA) approval in the US market for COVAXIN™. Ocugen is also in active discussions with manufacturers in the US to produce a significant number of doses of COVAXIN™ to support its US immunization program.

“The evaluation of COVAXIN™ has resulted in several unique product characteristics including long-term persistence of immune responses to multiple viral proteins, as opposed to only the spike protein, and has demonstrated broad spectrum neutralizing capability with heterologous SARS-CoV-2 strains, thus potentially reducing or eliminating escape mutants. Requiring only a standard vaccine storage temperature of 2-8oC and with the potential to treat all age-groups, COVAXIN™ may offer an important option to protect lives across America,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-Founder of Ocugen.

The Central Licensing Authority in India has granted permission for the sale or distribution of COVAXIN™ for restricted use in emergency situations in the public interest, in clinical trial mode. With the kickoff of what is likely to become the biggest national vaccination campaign in India’s history, COVAXIN™ is being administered as one of the two COVID-19 shots available under emergency authorization with the first batch of 30 million doses being administered to health professionals and front-line workers.

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™ is 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 several other vaccines, COVAXIN™ is packaged in multi-dose vials that can be stored at 2-8oC.

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 fight 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 US 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 140 global patents, a wide product portfolio of more than 16 vaccines, 4 bio-therapeutics, registrations in more than 116 countries, and 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 6 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 the introduction of path breaking WHO pre-qualified vaccines BIOPOLIO®, ROTAVAC® and Typbar TCV® combatting polio, rotavirus, typhoid infections, respectively. The recent acquisition of the rabies vaccine facility, Chiron Behring, from GlaxoSmithKline (GSK) has positioned Bharat Biotech as the largest rabies vaccine manufacturer in the world. 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 statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from our current expectations. 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
Chief Financial Officer
[email protected]

Media Contact:

For Ocugen:
LaVoieHealthScience

Lisa DeScenza
[email protected]

+1 978-395-5970

For Bharat Biotech:
Sheela Panicker
[email protected]

+91 984-980-9594

SOURCE: Ocugen

Release – Avivagen (VIVXF) – Announces Launch of Dr Tobias Beta Blend


Mimi’s Rock Corp. and Avivagen Announce Launch of Dr. Tobias Beta Blend on Amazon.com

 

Ottawa, ON / Business Wire/ February 1, 2021 / – Mimi’s Rock Corp. (TSXV:MIMI) and Avivagen Inc. (TSXV:VIV, OTCQB:VIVXF) (“Avivagen”), are pleased to announce the launch of Dr. Tobias Beta Blend available today through Amazon.com and DrTobias.com.

An exclusive formula featuring a Beta-Carotene Norisporenoid Blend and Vitamin A, Beta Blend provides advanced immune support while promoting eye and skin health.

“As an online leader in dietary supplements and wellness we are always looking to bring the next great product to our customers,“ says David Kohler, Chief Executive Officer, Mimi’s Rock Corp. “With COVID-19 bringing the importance of immune system health to the front of everyone’s mind, we believe that consumer demand for a product like Dr. Tobias Beta Blend will be strong from day one.”

Dr. Tobias Beta Blend is the first product designed for human consumption to leverage Avivigen’s proprietary OxC-betaTM technology, which supports the immune function of humans, livestock and companion animals through non-antibiotic means. OxC-betaTM works by supporting and priming the innate immune system while dampening chronic, overzealous inflammatory responses.

“We are very excited to bring our first nutraceutical designed and developed to promote advanced immune support for humans to market through our strong partnership with Mimi’s Rock,” says Kym Anthony, Chief Executive Officer, Avivagen, Inc. “There has already been exemplary success and uptake for OxC-betaTM applications for companion animal and livestock uses, including a high-quality supplement for companion animals launched with Mimi’s Rock last year. We believe Dr. Tobias Beta Blend will be well received by consumers looking to improve their immune system health.”

Dr. Tobias Beta Blend retails for USD $29.97 and is available exclusively through Amazon.com and DrTobias.com. Dr. Tobias Beta Blend is developed, marketed and sold by Centre Beach Inc., a joint venture company owned by Avivagen and Mimi’s Rock Corp.

About Mimi’s Rock Corp.

Mimi’s Rock Corp. is an online dietary supplement and wellness company which operates the Dr Tobias, All Natural Advice and Maritime Naturals brands. The Dr Tobias brand features over 30 products including the top-selling Colon 14 Day Cleanse and the #1 best-selling Omega 3 Fish Oil on Amazon.com. The Omega 3 Fish Oil is also the 4th largest subscribe & save product on Amazon.com. Mimi’s Rock Corp. has rapid growth plans as it continues to expand into global markets. For more information, visit www.mimisrock.com.

About Avivagen

Avivagen is a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications. By unlocking an overlooked facet of ?-carotene activity, a path has been opened to safely and economically support immune function, thereby promoting general health and performance in animals. Avivagen is a public corporation traded on the TSX Venture Exchange under the symbol VIV and on the OTCQB Exchange in the U.S. under the symbol VIVXF, and is headquartered in Ottawa, Canada, based in partnership facilities of the National Research Council of Canada and Charlottetown, Prince Edward Island. 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 plans of Avivagen’s customers and the potential for additional and/or increased orders from such customers, 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 potential for Avivgen’s products to be commercialized in human applications, the anticipated date of fulfillment for the order described, the possibility for OxCbeta ™ 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, demand for Avivagen’s products may not continue to grow and could decline, Avivagen’s brand recognition may not increase as anticipated or could be impacted by negative events, 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, new market access may not occur in the timeline or manner expected by Avivagen, 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 and the market opportunities may not be as large as Avivagen anticipates, in each case due to many factors, many of which are outside of Avivagen’s control. Readers are referred to the risk factors associated with the business of Avivagen set out in Avivagen’s most recent management’s discussion and analysis of financial condition available at www.SEDAR.com. Except as required by law, Avivagen assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those reflected in the forward-looking statements.

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

For more information:
Avivagen Inc.
Drew Basek
Director of Investor Relations
100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6
Phone: 416-540-0733
E-mail: [email protected]

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

SOURCE: Avivagen

Ayala Pharmaceuticals (AYLA) – First Patient Dose in Breast Cancer Trial

Friday, January 29, 2021

Ayala Pharmaceuticals (AYLA)
First Patient Dose in Breast Cancer Trial

Ayala Pharmaceuticals Inc clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations. The company’s current portfolio of product candidates, AL101 and AL102, targets the aberrant activation of the Notch pathway with gamma secretase inhibitors. Its product candidate, AL101, is being developed as a potent, selective, injectable small molecule gamma secretase inhibitor, or GSI. It is also developing AL101 for the treatment of T-ALL, an aggressive, rare form of T-cell specific leukemia.

Ahu Demir, Ph. D., Biotechnology Research Analyst, Noble Capital Markets, Inc.

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

    TNBC trial is active. Yesterday, Ayala Pharmaceuticals announced that the first patient was dosed in its Phase 2 TENACITY clinical trial of its potent, selective small molecule AL101 for the treatment of patients with Notch-activated recurrent or metastatic (R/M) triple negative breast cancer (TNBC).

    TENACITY details.  The open-label, multicenter, single arm Phase 2 study will evaluate the efficacy and safety of AL101 monotherapy in patients with Notch-activated R/M TNBC. It is expected to initially enroll up to 26 patients with Notch-activated R/M TNBC whose disease has recurred or progressed after three or fewer lines of prior therapy. Notch activation will be determined using a Next …



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

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

Release – Helius Medical Technologies (HSDT) – Announces Pricing of 9.6 Million Underwritten Public Offering Priced At Market

 


Helius Medical Technologies, Inc. Announces Pricing of $9.6 Million Underwritten Public Offering Priced At Market

 

NEWTOWN, Pa., Jan. 28, 2021 (GLOBE NEWSWIRE) — Helius Medical Technologies, Inc. (Nasdaq:HSDT) (TSX:HSM) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, announced today announced the pricing of an underwritten public offering of units for gross proceeds of approximately $9.6 million prior to deducting underwriting discounts and commissions and offering expenses payable by Helius. The offering is comprised of 647,772 Units, priced at a public offering price of $14.82 per unit, with each unit consisting of one share of common stock and a warrant to purchase 0.5 shares of common stock at an exercise price of $16.302 per share that expires on the fifth anniversary of the date of issuance.

The securities comprising the units are immediately separable and will be issued separately. The closing of the offering is expected to take place on or about February 1, 2021, subject to the satisfaction or waiver of customary closing conditions.

Ladenburg Thalmann & Co. Inc. is acting as the sole bookrunning manager of the offering.

A total of 647,772 shares of common stock and warrants to purchase up to 323,886 shares of common stock will be issued in the offering. In addition, the Company has granted the underwriters a 45-day option to purchase up to 97,164 additional shares of common stock and additional warrants to purchase up to 48,582 shares of common stock, solely to cover over-allotments, if any, at the public offering price per share and per warrant, less the underwriting discounts and commissions.

The securities were offered pursuant to a registration statement on Form S-1 (File No. 333-251804), which was declared effective by the United States Securities and Exchange Commission (“SEC”) on January 27, 2021 and an additional registration statement on Form S-1 (File No. 333-252495) filed pursuant to Rule 462(b), which became effective on January 27, 2021.

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. The offering is being made solely by means of a prospectus. A final prospectus relating to this offering will be filed by Helius with the SEC. When available, copies of the final prospectus can be obtained at the SEC’s website at www.sec.gov or from Ladenburg Thalmann & Co. Inc., Prospectus Department, 640 Fifth Avenue, 4th floor, New York, NY 10019 by email at [email protected].

About Helius Medical Technologies, Inc.

Helius Medical Technologies is a neurotech company focused on neurological wellness. The Company’s purpose is to develop, license and acquire unique and non-invasive platform technologies that amplify the brain’s ability to heal itself. The Company’s first commercial product is the Portable Neuromodulation Stimulator (PoNSTM). For more information, visit www.heliusmedical.com.

About the PoNS™ Device and PoNS Treatment™

The Portable Neuromodulation Stimulator (PoNS™) is authorized for sale in Canada as a class II, non-implantable, medical device intended as a short term treatment (14 weeks) of gait deficit due to symptoms from multiple sclerosis (MS), and chronic balance deficit due to mild-to-moderate traumatic brain injury (mmTBI) and is to be used in conjunction with physical therapy. The PoNS™ is an investigational medical device in the United States, the European Union (“EU”), and Australia (“AUS”). The device is currently under review for de novo classification and clearance by the FDA. It is also under premarket review by the AUS Therapeutic Goods Administration. PoNS™ is currently not commercially available in the United States, the European Union or Australia.

Cautionary Disclaimer Statement:

Certain statements in this news release are not based on historical facts and constitute forward-looking statements or forward-looking information within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Canadian securities laws. All statements other than statements of historical fact included in this news release are forward-looking statements that involve risks and uncertainties. Forward-looking statements are often identified by terms such as “believe,” “continue,” “look forward,” “will,” “committed to” and similar expressions. Such forward-looking statements include, among others, statements regarding the Company’s anticipated closing of the underwritten public offering and anticipated use of proceeds therefrom.

There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those expressed or implied by such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include the impact of the COVID-19 pandemic, the ability of the Company to close the offering, the Company’s need to raise additional capital to achieve its business objectives and other risks detailed from time to time in the filings made by the Company with securities regulators, and including the risks and uncertainties about the Company’s business described in the “Risk Factors” sections of the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 and its other filings with the United States Securities and Exchange Commission and the Canadian securities regulators, which can be obtained from either at www.sec.gov or www.sedar.com.

The reader is cautioned not to place undue reliance on any forward-looking statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company assumes no obligation to update any forward-looking statement or to update the reasons why actual results could differ from such statements except to the extent required by law.

The Toronto Stock Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.

Investor Relations Contact:

Westwicke Partners on behalf of Helius Medical Technologies, Inc.
Mike Piccinino, CFA
443-213-0500

[email protected]

SOURCE: Helius Medical Technologies, Inc.

Release – Avivagen (VIVXF) – Announces Six Tonne Order of OxC-betaTM Livestock from New Customer in Mexico


Avivagen Announces Six Tonne Order of OxC-betaTM Livestock from New Customer in Mexico

 

Significant and ongoing order complements previous ten tonne order from established customer Industrias Melder

Ottawa, ON / Business Wire/ January 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 enhance and support immune function, thereby supporting general health and performance, is pleased to announce that it has secured a six tonne order of OxC-betaTMTransformadora Agricola de Alimentos S.A. de C.V in Mexico.

The order, comprised of monthly fulfilments of 500 kilograms each over a one year period starting in April 2021, is the first order of OxC-betaTM Livestock from the new customer. The order represents the second of significant size in Mexico in recent months, following a ten tonne order by Industrias Melder in September, 2020.

“We are excited to add a prominent new customer and announce another significant order for OxC-betaTM Livestock in Mexico, a key and growing region for Avivagen,” said Kym Anthony, Chief Executive Officer, Avivagen. “With a number of prospective customers currently running or having completed trials of their own, we anticipate demand for OxC-betaTM Livestock to continue to grow steadily in this increasingly significant region.”

Located in the city of Santiago de Queretaro, Transformadora Agricola de Alimentos S.A. de C.V. was founded and is owned by Raúl Troyo de la Llave, a leading figure in the Mexican industrial agriculture sector for nearly four decades. Mr. Troyo de la Llave is heavily involved in numerous important and influential livestock associations throughout Mexico, including the Querétaro Pig Producers Association, the Livestock Association of Querétaro and the Mexican Association of Food Producers A.C. (Asociación Mexicana de Productores de Alimentos A.C., also known as AMEPA).

Avivagen expects the first shipment to commence in April, 2021. This order was received through Avivagen’s Mexican consultant Meyenberg International Group.

About Avivagen

Avivagen is a life sciences corporation focused on developing and commercializing products for livestock, companion animal and human applications. By unlocking an overlooked facet of ?-carotene activity, a path has been opened to safely and economically support immune function, thereby promoting general health and performance in animals. Avivagen is a public corporation traded on the TSX Venture Exchange under the symbol VIV and on the OTCQB Exchange in the U.S. under the symbol VIVXF, and is headquartered in Ottawa, Canada, based in partnership facilities of the National Research Council of Canada and Charlottetown, Prince Edward Island. For more information, visit www.avivagen.com. The contents of the website are expressly not incorporated by reference in this press release.

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

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

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

Forward Looking Statements

This news release includes certain forward-looking statements that are based upon the current expectations of management. Forward-looking statements involve risks and uncertainties associated with the business of Avivagen Inc. and the environment in which the business operates. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking, including those identified by the expressions “aim”, “anticipate”, “appear”, “believe”, “consider”, “could”, “estimate”, “expect”, “if”, “intend”, “goal”, “hope”, “likely”, “may”, “plan”, “possibly”, “potentially”, “pursue”, “seem”, “should”, “whether”, “will”, “would” and similar expressions. Statements set out in this news release relating to the future plans of Avivagen’s customers and the potential for additional and/or increased orders from such customers, 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 potential for Avivgen’s products to be commercialized in human applications, the anticipated date of fulfillment for the order described, the possibility for OxCbeta ™ 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, demand for Avivagen’s products may not continue to grow and could decline, Avivagen’s brand recognition may not increase as anticipated or could be impacted by negative events, 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, new market access may not occur in the timeline or manner expected by Avivagen, 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 and the market opportunities may not be as large as Avivagen anticipates, in each case due to many factors, many of which are outside of Avivagen’s control. Readers are referred to the risk factors associated with the business of Avivagen set out in Avivagen’s most recent management’s discussion and analysis of financial condition available at www.SEDAR.com. Except as required by law, Avivagen assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those reflected in the forward-looking statements.

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

For more information:
Avivagen Inc.
Drew Basek
Director of Investor Relations
100 Sussex Drive, Ottawa, Ontario, Canada K1A 0R6
Phone: 416-540-0733
E-mail: [email protected]

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

SOURCE: Avivagen

Ayala Pharmaceuticals (AYLA) – Noblecon17 Presentation Emphasizes the Positive Trajectory and the Upcoming Catalysts

Monday, January 25, 2021

Ayala Pharmaceuticals (AYLA)
Noblecon17 Presentation Emphasizes the Positive Trajectory and the Upcoming Catalysts

Ayala Pharmaceuticals Inc clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations. The company’s current portfolio of product candidates, AL101 and AL102, targets the aberrant activation of the Notch pathway with gamma secretase inhibitors. Its product candidate, AL101, is being developed as a potent, selective, injectable small molecule gamma secretase inhibitor, or GSI. It is also developing AL101 for the treatment of T-ALL, an aggressive, rare form of T-cell specific leukemia.

Ahu Demir, Ph. D., Biotechnology Research Analyst, Noble Capital Markets, Inc.

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

    CEO presentation highlighted the path forward for the company. Roni Mamluk, CEO of Ayala Pharmaceuticals participated in the Targeted Oncology Therapeutics panel and presented at Noblecon17. A replay can be accessed at https://channelchek.vercel.app/news-channel/NobleCon17_Rebroadcast . Both her participation and presentation highlighted Ayala’s foundation, pipeline, the roadmap to the next steps, and also value-generating catalysts for the shares.

    Pipeline offers substantial value expansion.  The company recently initiated Phase 2 in triple-negative breast cancer (TNBC) and received FDA’s approval to commence pivotal Phase 2/3 trial (RINGSIDE) in desmoid tumors (anticipated in H1 2021). We believe Springworks’ topline data from the registrational Phase 3 trial (DeFi) in Q2/Q3 2021 will act as a major inflection point for the company, as it …



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. 

Lineage Cell Therapeutics (LCTX) – CFO Left Reiterating Outperform Rating

Thursday, January 21, 2021

Lineage Cell Therapeutics (LCTX)
CFO Left, Reiterating Outperform Rating

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.

Ahu Demir, Ph. D., Biotechnology Research Analyst, Noble Capital Markets, Inc.

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

    CFO left. Lineage announced that Brandi Roberts, Chief Financial Officer, is leaving the company, effective January 20th, 2020 following her resignation on January 15th, 2021. Reasons for her leave were personal. She will be taking a CFO position at a private company, Longboard Pharmaceuticals.

    CEO will serve as an interim CFO.  The company has initiated efforts to find another CFO. Ms. Roberts also agreed to provide consulting services to Lineage for an orderly and smooth transition to the new CFO. Chief Executive Officer Brian Culley will serve as Interim Chief Financial Officer until the new CFO is appointed …



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. 

Xenetic Biosciences (XBIO) NobleCon17 Presentation Replay


Xenetic Biosciences (XBIO) CEO Jeffrey Eisenberg at NobleCon17 – Noble Capital Markets 17th Annual Small & Microcap Investor Conference – January 2021. Following the formal presentation, Noble Capital Markets Senior Research Analyst Ahu Demir, PhD joins Jeffrey to moderate a Q&A session.

NobleCon 17 Complete Rebroadcast

VolitionRx (VNRX) NobleCon17 Presentation Replay


VolitionRx (VNRX) CFO Scott Powell and CEO Cameron Reynolds at NobleCon17 – Noble Capital Markets 17th Annual Small & Microcap Investor Conference – January 2021. Following the formal presentation, Noble Capital Markets Senior Research Analyst Ahu Demir, PhD joins Scott and Cameron to moderate a Q&A session.

NobleCon 17 Complete Rebroadcast

RenovaCare (RCAR) NobleCon17 Presentation Replay


RenovaCare (RCAR) CEO Alan Rubino and Chief Scientific Officer Robin Robinson at NobleCon17 – Noble Capital Markets 17th Annual Small & Microcap Investor Conference – January 2021. Following the formal presentation, Noble Capital Markets Senior Research Analyst Ahu Demir, PhD joins Alan and Robin to moderate a Q&A session.

NobleCon 17 Complete Rebroadcast

Petros Pharmaceuticals (PTPI) NobleCon17 Presentation Replay


Petros Pharmaceuticals (PTPI) President Fady Boctor at NobleCon17 – Noble Capital Markets 17th Annual Small & Microcap Investor Conference – January 2021. Following the formal presentation, Noble Capital Markets Senior Research Analyst Ahu Demir, PhDjoins Fady to moderate a Q&A session.

NobleCon 17 Complete Rebroadcast