Onconova Therapeutics Inc. (ONTX) – Phase 1 Trial Commencement for CDK4 6 ARK5 Program in H1 2021, Rating Raised

Tuesday, December 22, 2020

Onconova Therapeutics Inc. (ONTX)
Phase 1 Trial Commencement for CDK4/6 ARK5 Program in H1 2021, Rating Raised

Onconova Therapeutics Inc is a clinical-stage biopharmaceutical company operating in the US. It focuses on discovering and developing novel small molecule product candidates primarily to treat cancer. The company has created a library of targeted agents designed to work against cellular pathways important to cancer cells. Its product candidates are Single-agent IV rigosertib, Oral rigosertib + azacitidine, IV Briciclib, Recilisib, and ON 123300. The key product candidate Rigosertib is a small molecule which blocks cellular signaling by targeting RAS effector pathways.

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

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

    The trial is expected to commence in H1 2021. Onconova’s dual CDK4/6 and ARK5 inhibitor ON 123300 is set to enter the clinic in H1 2021 following the Investigational New Drug (IND) filing approval announced yesterday. CDK4/6 coupled with ARK5 inhibition is a unique and innovative approach and potentially represents an effective strategy to treat patients who are resistant or refractory to CDK4/6 therapeutics.

    Details of Phase 1 study and the potential market opportunity.  The Phase 1 study will assess the safety, tolerability, and pharmacokinetics of ON 123300 administered orally as monotherapy at increasing doses starting at 40 mg daily for consecutive 28-day cycles. The target population includes but is not limited to HR+ HER2- metastatic breast cancer patients with clinical resistance to approved …



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

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

Release – Avivagen (VIVXF) – Announces Results for Fiscal Year Ending October 31 2020


Avivagen Inc. Announces Results for Fiscal Year Ending October 31, 2020

 

Ottawa, ON /Business Wire/ December 16, 2020 / — Avivagen Inc. (TSXV:VIV, OTCQB:VIVXF) (“Avivagen” or the “Company”) today reported its audited financial results for the fiscal year ended October 31, 2020. Unless otherwise noted, all figures are in Canadian currency.

“By all measures, Avivagen achieved considerable regulatory, customer, corporate and financial success in 2020,” said Kym Anthony, President and Chief Executive Officer, Avivagen Inc. “We’ve secured record breaking orders for OxC-beta from customers in established markets and received regulatory approval in key markets in Asia and South America. The successes achieved this year position Avivagen very strongly for continued growth worldwide, as we grow recurring order sizes and add new customers and partners in important feed production markets around the globe.”

Highlights from Avivagen’s fiscal 2020 include:

Regulatory Milestones

  • Secured approval for OxC-betaTM Livestock in Malaysia on December 5, 2019. Malaysia had an estimated total annual feed production of 4.8 million metric tonnes in 2019.
  • Signed agreement with COFCO Biotech on December 19, 2019 to support approval process efforts in China. COFCO is a leading supplier of agri-products to the Chinese market, with more than $17.5 billion in annual sales in 2018.
  • Secured approval in Brazil on June 24, 2020. Brazil is the world’s third largest feed production market, and a key exporter to regions such as Europe and China that have implemented bans against the use of antibiotics in livestock feed.
  • Secured first order in Malaysia on December 12, 2019, only a week after receiving regulatory approval in the country.
  • Secured first order in Mexico, by Industrias Melder, on March 25, 2020.
  • Secured new sales of OxC-betaTM Livestock in Taiwan and Thailand on April 2, 2020. Avivagen followed those sales with the Company’s largest sales order to date – a three tonne order by UNAHCO in the Philippines – less than a week later.
  • Mexico-based customer, Industrias Melder placed orders totaling two tonnes by May 20, 2020, following the positive results of two tests conducted by a key dairy farm client.
  • Secured first order for 125kg from Look Chemicals, Avivagen’s distribution partner in Brazil, on August 12, 2020.
  • Finalized record ten tonne order of OxC-beta from Industrias Melder on September 28, 2020, commencing early 2021, as well as new orders from Tesistan and Prolea in Mexico on October 6, 2020. Avivagen also joined Mexico-based industry associations, ANFACA and AMEPA at the same time, further connecting with the feed production communities across key regions in Mexico.
  • Secured record four tonne order from UNAHCO on October 13, 2020, marking the largest order to date from the Philippines. As a result of a typhoon which occurred in the region following the order, two tonnes of the order were shipped during Fiscal 2020, with the other two tonnes shipped in November 2020.
  • Received repeat and growing orders from Fwusow, one of Taiwan’s leading feed producers and integrators, for the use of OxC-beta in their pet food.
  • Completed the first sale of OxC-beta for use in layer hens, resulting in increased egg production and accolades from the producer.
  • Completed preparations for the launch of a human dietary health supplement in the US. The dietary supplement is set to launch via e-commerce within the next few weeks.

Financial and Corporate Milestones

  • Secured private placements of $1.25mm and $1.75mm on January 3 and January 27, 2020 respectively.
  • Listed on the OTCQB® Venture Market on January 8, 2020, helping to expand Avivagen’s investor presence in the United States.
  • Launched Dr. Tobias Dog Chews with Mimi’s Rock Corp. on Amazon.com and DrTobias.com on January 23, 2020.
  • Received positive results from New Zealand livestock dairy trail for sub-clinical mastitis on February 24, 2020, which extends the further use cases of OxC-betaTM Livestock.
  • Published a scientific paper “The effects of maternal supplementation with fully oxidised ?-carotene on the reproductive performance and immune response of sows, as well as the growth performance of nursing piglets” in the British Journal of Nutrition on August 18, 2020.

Fiscal 2020 Financial Results

The Company’s Audited Financial Statements for the year ended October 31, 2020 and the accompanying Management’s Discussion and Analysis have been filed on the System for Electronic Document Analysis and Retrieval and are available via its website (www.sedar.com). The financial information for the year ended October 31, 2020 should be read in conjunction with the Company’s Audited Financial Statements as well as its Management’s Discussion and Analysis for the year ended October 31, 2020.

The Company reported revenues of $1,177,857 ($977,451 in the year ending October 31, 2019) and a comprehensive loss of $(4,751,287) for the year ended October 31, 2020. This compares to a comprehensive loss in the year ending October 31, 2019 of $(4,836,420). As at October 31, 2020, the Company reported total assets of $2,176,142 (current assets of $1,781,800), total liabilities of $6,943,752, and shareholders’ deficit of ($4,767,610).

Significant financing inflows in the fiscal year totalled $3,750,000. This consisted of a private placement equity financing of $3,000,000 and a debt financing of $750,000 all raised within the confines of a volatile and challenging market.

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

Is a Cure for Diabetes Being Studied?

 


Are Biotech Scientists on the Road to a Cure for Type One Diabetes?

 

How close are we to potentially having a functional cure for diabetes? This was the question asked of a panel of world-renowned experts at T1D Day “The Beginning of the End; Close to a Cure.” The late November event featured a panel of world-renowned experts, who are well qualified to respond to this question. Nathan Cali, who is a Managing Director of Investment Banking, specializing in healthcare at Noble Capital Markets, led the discussion with the experts in the field of Diabetes, ALS, immunosuppression, and transplantation. Much of the discussion centered around CD40/CD40L FDA phase II safety and efficacy trials and ongoing progress toward a functional cure for T1D using islet cell transplantation.

The event held by Noble Capital Markets, Inc. and Channelchek also gave insight into progress in other areas of organ or cell-based transplants and immunological diseases. The main focus was on how close we are to a functional cure for T1D and the role the company Novus Therapeutics, Inc. (NASDAQ; NVUS) has taken to make this a reality. Novus has organized a team it believes is capable of managing and navigating the biomedical challenges, FDA approval processes, and the capital needs necessary to take this dream much closer to an actuality. Novus is a clinical-stage biopharmaceutical company focused on targeted medicines for patients undergoing organ or cellular transplantation, as well as immunological diseases.

T1D Day Presenters from Top Left:

Nathan Cali, Managing Director of Investment Banking specializing in healthcare at Noble Capital Markets
Dr. Steven Perrin, President & CSO, Novus Therapeutics
Dr. David Gros, Chief Executive Officer Novus Therapeutics
Dr. Norma Sue Kenyon, Martin Kleiman Professor of Surgery, Microbiology and Immunology and Biomedical Engineering, Vice Provost for Innovation
Dr. James Markmann, Chief of the Division of Transplant Surgery and Director of Clinical Operations at the Transplant Center at Massachusetts General Hospital
Dr. Camillo Ricordi, Director of the Diabetes Research Institute at the University of Miami School of Medicine – Ranked as the World Leader in Islet Cell Transplant
Watch the Replay

Advancements in T1D Research

The approach being taken by Novus involves transplanting islet cells into the host suffering from T1D. Islet cells produce insulin; the lack of insulin production is the cause of type 1 diabetes. A hurdle with transplantations of any type, including cell transplantations, is host rejection. Much of the conversation centers around getting around host rejection of implantation. The approach taken by Novus, as explained early in the discussion by CEO Dr. David Alexandre Gros, is an alternative approach with two possible methods to target immune response, “you can think of it as a lock and key, one can go after what’s called the ligand, or one can go after the receptor.” The CD40/CD40L trials use these molecules to impact the ligand or the “key.” Dr. Gros explained their approach, “The research, what’s interesting in the CD40 space is that we believe that going after the ligand is the better way to do it and one that could potentially allow us to get greater efficacy from our molecule.” In his view, if they had instead targeted the receptor (not the ligand), they would be testing an approach that has been explored for years and has experienced safety concerns.

 If the pathway to the immune response of rejection can be effectively impacted, islet cells may have a longer life in the host.

 

About CD40/CD40L

Source: Novus Therapeutics, Inc.

Promising Results

The presenters were cautious not to produce hope or hype around their part in the research. However, Dr. Camillo Ricardi expressed enthusiasm toward the research and promise in the results. Dr. Ricordi revolutionized a method to transplant islet cells in a way where the host would begin producing insulin. His approach remains the gold standard for human pancreas processing. The second part of any transplantation is preventing an immunological response against the transplanted cells. His previous work on islet cell acceptance, he had spent years researching and experimenting with a CD40L predecessor as an immunosuppressant. Permission to study that molecule had been withdrawn, which left his research toward a biological cure unfinished. During the audience, Q&A at the T1D Day discussion Dr. Ricordi referred to the reasons for the withdrawal of the old immune suppressant molecule and the current version, “This is a much better molecule which doesn’t share the same biological effect.” Dr. Ricordi believes that a combination of other immunological strategies, along with an increased supply of islet cells to work with, will allow them to induce tolerance and suppress the immune response. He again offered that the ligand strategy with its synergistic effects could bring about a biological cure.

Dr. Steven Perrin said the first phase II studies on islet cell transplant has been approved to start in Canada. Dr. Gros added that Novus is in phase II of ALS studies; they have been through phase I safety studies, and their next indication will be islet cells  within Canada.

Results of Islet Cell Grafts

Source: Channelchek T1D Day video replay

 

Recent Transactions for NVUS

Dr. Gros discussed the Anelixis transaction and other key financial affairs of his company, “what we’ve done was one [transaction] where Novus acquired a private company called Anelixis in a stock for a stock transaction where Anelixis equity holders received both common stock as well as a convertible preferred stock. At the same time, we entered into an agreement to do a financing, and this was for this same non-voting preferred stock, which we did as a private placement with a terrific blue-chip group of investors including, Cormant, Fidelity, Janus, and some others. Together they allowed us to raise over $108 million dollars in gross proceeds. We’ll use these proceeds in order to develop.” The Novus CEO also reported,” as we announced in our last quarterly earnings call, we finished September 30, 2020 with almost $115 million dollars in cash in the bank. We expect to receive an additional $9 million, through some more financing which has been deferred until with the potential conversion of our preferred stock into common shares.”

Take-Away

T1D Day “The Beginning of the End; Close to a Cure” delivered on its promise to be interesting, and exciting in the implications of what was presented. According to the ADA, 1.25 million Americans suffer from Type 1 Diabetes. Success in finding a functional cure could literally change the world for people who suffer from it.

The discussion also provided valuable context to investors who are considering investments in biotech companies involved in transplantation and immunological response. The entire T1D video is available on Channelchek for those who are premium members. Premium Channelchek registration is fast and free and will allow access to all content. Register here.

Watch the T1D Day Panel Presentation

 

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PDS Biotechnology C-Suite Interview

 


Release – Xenetic Biosciences (XBIO) – Announces Positive Data from Pivotal Phase 3 Clinical Trial Utilizing PolyXen(R) Platform Technology

 


Xenetic Biosciences, Inc. Announces Positive Data from Partner’s Pivotal Phase 3 Clinical Trial Utilizing PolyXen(R) Platform Technology

 

  • Xenetic leverages its proprietary drug delivery platform, PolyXen, through partnerships with biotechnology and pharmaceutical companies to improve the half-life and other pharmacological properties of next-generation biologic drugs
  • Epolong, a polysialylated form of recombinant human erythropoietin that leverages PolyXen, has been shown to be effective and generally well tolerated in Pharmsynthez-conducted trial as a treatment for anemia in patients with chronic kidney disease

FRAMINGHAM, MA / ACCESSWIRE / December 9, 2020 / Xenetic Biosciences, Inc. (NASDAQ:XBIO) (“Xenetic” or the “Company”), a biopharmaceutical company focused on advancing XCART™, a personalized CAR T platform technology engineered to target patient- and tumor-specific neoantigens, today announced its partner, PJSC Pharmsynthez, has reported in a press release positive data from its pivotal Phase 3 clinical study leveraging PolyXen® to develop a treatment for anemia in patients with chronic kidney disease (CKD).

PolyXen is Xenetic’s patent-protected platform technology designed for protein or peptide therapeutics, enabling next-generation biological drugs by prolonging a drug’s circulating half-life and potentially improving other pharmacological properties. The PolyXen technology platform was used by Pharmsynthez to develop Epolong (also known as ErepoXen™ or PSA-EPO), a polysialylated form of recombinant human erythropoietin, a hormone produced by the kidneys to promote blood cell production. Pharmsynthez reported in its press release that Epolong is under investigation with the goal of reducing the required dosing frequency and reducing potential side effects, as compared to existing EPO products.

As reported in the press release issued by Pharmsynthez, the pivotal Phase 3 multi-center randomized study was conducted in Russia by Pharmsynthez and was designed to study the efficacy, safety and tolerability of Epolong in comparison with Aranesp® (darbepoetin alfa), the current leader in the long-acting erythropoietin segment. The study enrolled approximately 150 patients with CKD across 36 medical institutions. The results of the study indicated that Epolong was non-inferior to Aranesp with respect to primary and secondary endpoints. Furthermore, the proportion of patients who achieved the target hemoglobin range (10.0-12.0 g/dL inclusive) during the evaluation period was 74% in the Epolong group versus 52% in the Aranesp group. Pharmsynthez also reported that the study revealed that the proportion of patients who exceeded the target threshold level of hemoglobin (12.0 g/dL) was 3.5 times greater in the Aranesp group than in the Epolong group (34.7% versus 10.0%, respectively).

“The PolyXen platform continues to demonstrate broad utility and ability to modulate the pharmacokinetic and pharmacodynamic profiles of protein drugs. We are pleased with the positive results Pharmsynthez has reported and we look forward to the outcome of their registration filing in Russia for Epolong, which they expect to submit in 2021,” commented Jeffrey Eisenberg, Chief Executive Officer of Xenetic.

In clinical and preclinical settings, therapeutic proteins polysialylated with the PolyXen platform have been shown to have extended circulating half-life, improved thermodynamic stability and resistance to proteases, while retaining pharmacological activity. PolyXen has been demonstrated in human clinical trials to confer prolonged half-life on biotherapeutics such as recombinant human erythropoietin and recombinant Factor VIII (“rFVIII”). PolyXen has potential utility in other molecule classes such as peptides and small molecules. The Company is leveraging its PolyXen technology through an exclusive license agreement with Takeda Pharmaceuticals Co. Ltd. in the field of coagulation disorders and receives royalty payments under this agreement.

About Pharmsynthez

Pharmsynthez PJSC (MOEX: LIFE) is a Russian pharmaceutical company that develops new medicines, drug technologies for organ-specific delivery, and innovative methods of manufacturing pharmaceutical ingredients. The company is engaged in production and sale of both medicines for the treatment of respiratory diseases (original OM) and active pharmaceutical ingredients (API). The company has a research and production complex in Kapitolovo, commissioned in 2001. Pharmsynthez actively cooperates with North American, Canadian and European companies in the field of chemical compounds and API production.

About Xenetic Biosciences

Xenetic Biosciences, Inc. is a biopharmaceutical company focused on progressing XCART™, a personalized CAR T platform technology engineered to target patient- and tumor-specific neoantigens. The Company is initially advancing cell-based therapeutics targeting the unique B-cell receptor on the surface of an individual patient’s malignant tumor cells for the treatment of B-cell lymphomas. XCART™ has the potential to fuel a robust pipeline of therapeutic assets targeting high-value oncology indications.

Additionally, Xenetic is leveraging PolyXen®, its proprietary drug delivery platform, by partnering with biotechnology and pharmaceutical companies. PolyXen® has demonstrated its ability to improve the half-life and other pharmacological properties of next-generation biologic drugs. The Company has an exclusive license agreement with Takeda Pharmaceuticals Co. Ltd. in the field of coagulation disorders and receives royalty payments under this agreement.

For more information, please visit the Company’s website at www.xeneticbio.com and connect on Twitter, LinkedIn, and Facebook.

Forward-Looking Statements

This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as “expects,” “plans,” “projects,” “will,” “may,” “anticipates,” “believes,” “should,” “intends,” “estimates,” and other words of similar meaning, including, but not limited to, statements regarding: expectations regarding Epolong’s investigation and goal of reducing the required dosing frequency and reducing potential side effects compared to existing EPO products; our belief that the PolyXen platform continues to demonstrate broad utility and ability to modulate the pharmacokinetic and pharmacodynamic profiles of protein drugs; expectations regarding the outcome of Pharmsynthez’s registration filing in Russia for Epolong and timing of such registration filing, which is expected to be submitted in 2021; our plans to initially apply the XCART technology to advance cell-based therapeutics by targeting the unique B-cell receptor on the surface of an individual patient’s malignant tumor cells for the treatment of B-cell lymphomas; our expectations that XCART has the potential to fuel a robust pipeline of therapeutic assets targeting high-value oncology indications; our plans to leverage PolyXen® by partnering with biotechnology and pharmaceutical companies; and our expectation regarding receipt of royalty payments under the exclusive license agreement with Takeda Pharmaceuticals Co. Ltd. Any forward-looking statements contained herein are based on current expectations, and are subject to a number of risks and uncertainties. Many factors could cause our actual activities, performance, achievements, or results to differ materially from the activities and results anticipated in forward-looking statements. Important factors that could cause actual activities, performance, achievements, or results to differ materially from such plans, estimates or expectations include, among others, (1) unexpected costs, charges or expenses resulting from the acquisition of XCART; (2) uncertainty of the expected financial performance of the Company following completion of the acquisition of XCART; (3) failure to realize the anticipated potential of the XCART or PolyXen technology; (4) the ability of the Company to implement its business strategy; (5) failure of the Pharmsynthez to timely register Epolong in Russia, or at all; and (6) other risk factors as detailed from time to time in the Company’s reports filed with the SEC, including its annual report on Form 10-K, periodic quarterly reports on Form 10-Q, periodic current reports on Form 8-K and other documents filed with the SEC. The foregoing list of important factors is not exclusive. In addition, forward-looking statements may also be adversely affected by general market factors, general economic and business conditions, including potential adverse effects of public health issues, such as the COVID-19 outbreak on economic activity, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new product candidates and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and the Company does not undertake any obligation to update forward-looking statements, except as required by law.

Contact:
JTC Team, LLC
Jenene Thomas
(833) 475-8247
[email protected]

SOURCE: Xenetic Biosciences, Inc.

Ayala Pharmaceuticals (AYLA) – Top NOTCH Targeting for Broad Oncology Indications, Initiating Coverage at Outperform

Wednesday, December 02, 2020

Ayala Pharmaceuticals (AYLA)
Top NOTCH Targeting for Broad Oncology Indications, Initiating Coverage at Outperform

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.

    Clinical benefit in ACC patients. We initiate coverage on Ayala Pharmaceuticals (AYLA). Ayala’s assets, AL101 and AL102, are gamma-secretase inhibitors that hold promising potential in multiple oncology indications. Interim results from the ongoing Phase 2 clinical study (ACCURACY) of AL101 showed encouraging clinical activity (68% disease control rate) in patients with adenoid cystic carcinoma (ACC, rare cancer that predominantly arises within salivary glands). In our view, Ayala is the most advanced in the clinical for the treatment of ACC patients harboring NOTCH-activating mutations and holds Fast Track and Accelerated Approval Designations. We assume a straightforward regulatory process attributed to high unmet needs with limited current treatment options in this untapped market.

    Pipeline expansion offers substantial upside.  We believe further value to crack through the defenses of other oncology indications beyond ACC upon meaningful data. Plenty of value-unlocking catalysts should support the stock near-medium term including the commencement of three Phase 2 clinical studies in triple-negative breast cancer (TNBC, in Q4 2020), in desmoid tumors (in H1 2021), and in acute …



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. 

T1D-Day – The Beginning of the End; Close to a Cure – Panel Discussion Replay


In 1988 Dr. Camillo Ricordi revolutionized a method of transplantation of islet cells (cells that produce insulin) which remains the gold standard for human pancreas processing today. The problem is, like with so many other types of transplantation, the body often rejects the new cells. All that could change with the introduction of this anti-rejection antibody – Novus Therapeutics, Inc. (NASDAQ:NVUS) – CD40/CD40L – FDA Phase II.

Join Dr. Ricordi and his world-class panel of experts who weigh-in on the likelihood of this medical breakthrough. They also look at what the future may hold for investors in the technology, and those who are considering an investment. It’s T1D-Day, with the hopeful surrender of this debilitating disease just around the corner.

Panelists: Dr. Camillo Ricordi, Director of the Diabetes Research Institute at the University of Miami School of Medicine – Ranked as the World Leader in Islet Cell Transplant

Dr. James Markmann, Chief of the Division of Transplant Surgery and Director of Clinical Operations at the Transplant Center at Massachusetts General Hospital, and the Claude Welch Professor of Surgery at Harvard Medical School

Dr. Norma Sue Kenyon, Martin Kleiman Professor of Surgery, Microbiology and Immunology and Biomedical Engineering, Vice Provost for Innovation

Dr. David Gros, Chief Executive Officer Novus Therapeutics

Dr. Steven Perrin, President & CSO, Novus Therapeutics.

T1D-Day – The Beginning of the End; Close to a Cure – Panel Discussion


In 1988 Dr. Camillo Ricordi revolutionized a method of transplantation of islet cells (cells that produce insulin) which remains the gold standard for human pancreas processing today. The problem is, like with so many other types of transplantation, the body often rejects the new cells. All that could change with the introduction of this anti-rejection antibody – Novus Therapeutics, Inc. (NASDAQ:NVUS) – CD40/CD40L – FDA Phase II.

Join Dr. Ricordi and his world-class panel of experts who weigh-in on the likelihood of this medical breakthrough. They also look at what the future may hold for investors in the technology, and those who are considering an investment. It’s T1D-Day, with the hopeful surrender of this debilitating disease just around the corner.

Panelists: Dr. Camillo Ricordi, Director of the Diabetes Research Institute at the University of Miami School of Medicine – Ranked as the World Leader in Islet Cell Transplant

Dr. James Markmann, Chief of the Division of Transplant Surgery and Director of Clinical Operations at the Transplant Center at Massachusetts General Hospital, and the Claude Welch Professor of Surgery at Harvard Medical School

Dr. Norma Sue Kenyon, Martin Kleiman Professor of Surgery, Microbiology and Immunology and Biomedical Engineering, Vice Provost for Innovation

Dr. David Gros, Chief Executive Officer Novus Therapeutics

Dr. Steven Perrin, President & CSO, Novus Therapeutics.

Release – Ceapro Inc. (CRPOF) – Ceapro Inc. Reports 2020 Third Quarter and Nine-Month Financial Results and Operational Highlights

 

Ceapro Inc. Reports 2020 Third Quarter and Nine-Month Financial Results and Operational Highlights

 

EDMONTON, Alberta, Nov. 27, 2020 (GLOBE NEWSWIRE) — Ceapro Inc. (TSX-V: CZO; OTCQX: CRPOF) (“Ceapro” or the “Company”), a growth-stage biotechnology company focused on the development and commercialization of active ingredients for healthcare and cosmetic industries, today announced financial results and operational highlights for the third quarter and the first nine months ended September 30, 2020.

– R&D activities focused on advancing the development of innovative delivery systems and yeast beta glucan as a potential inhalable therapeutic for COVID-19 –
– Q3 2020 sales of $3,476,000 compared to $2,908,000 for Q3 2019, representing a 20% increase –
– Net profit of $192,000 for Q3 2020 vs. net loss of $104,000 for Q3 2019 –
– Cash generated from operations of $4,777,000 in 2020 vs. $1,321,000 in 2019 –
– Maintained production operations during COVID-19 pandemic and completed integration of manufacturing sites –

“Over the course of the third quarter, our operations executed and adapted well, delivering significantly improved year over year results even during the final phase of integration of the production operations and despite the COVID-19 pandemic situation. We successfully completed the full integration of manufacturing operations under one roof in Edmonton, resumed the clinical trial for beta glucan as a cholesterol reducer, as well as the development and optimization of new products developed through the use of our PGX disruptive technology. Additionally, we are extremely proud of our employees who worked tirelessly since the beginning of the year to maintain operations and deliver these solid results despite the COVID-19 pandemic. As we continue to move forward, our focus remains on the health and safety of our associates, followed by business continuity,” stated Gilles Gagnon, M.Sc., MBA, President and CEO of Ceapro.

Corporate and Operational Highlights

Pipeline Development:

  • Announced publication of positive results from study evaluating avenanthramides in exercise-induced inflammation in the international, peer-reviewed Journal of the International Society of Sports Nutrition.
  • Achieved the first milestones in successful development of PGX-processed yeast beta glucan product as a potential inhalable therapeutic for COVID-19 and other fibrotic endpoint diseases of the lung.
  • Confirmed capability of PGX Technology to optimize and standardize the size and morphology of yeast beta-glucan (PGX-YBG) suitable for lung inhalation.
  • Conducted in-vitro study with human cell lines demonstrating that PGX-YBG obtained from different sources exhibited significant stimulatory effect on human immune response through activation of beta glucan specific Dectin 1 receptors.
  • Ongoing PGX-YBG project with McMaster University conducted in parallel for naïve and preclinical animal models. To-date, no safety issues have been encountered. The preclinical phase has been extended to identify the maximum tolerated dose. Progress update on this exciting project to be issued in the near future.
  • Conducting additional in vitro PGX-YBG dose response study to correlate with upcoming McMaster animal study results.
  • Resumed enrollment of patients for the clinical trial with beta glucan as a cholesterol reducing natural pharmaceutical product. 191 patients have been screened and 65 randomized during the last three months.
  • Pursued the development of new PGX-dried chemical complexes for potential applications under various forms like pills, capsules, fast dissolving strips and face masks. Yeast beta glucan to become a key product of Ceapro’s portfolio.

Technology:

  • Made significant technical upgrades of PGX demo plant to allow production of yeast beta glucan for a potential human clinical trial with COVID-19.
  • Acquired pieces of equipment suitable for the assembling of a commercial scale PGX unit. Timelines to initiate building of the customized large scale unit to be defined due to COVID-19 travel restrictions and resulting availability of expert personnel.
  • Initiated installment of a commercial scale unit for impregnation of bioactives with PGX-processed biopolymers.
  • Pursued research collaboration projects with University of Alberta and McMaster University for the impregnation of various bioactives using PGX-processed biopolymers as potential delivery systems for multiple applications in healthcare.

Production Operations:

  • Completed the decommissioning of Leduc manufacturing site and the moving of all production operations to the Edmonton based facility.

Corporate:

  • Fully repaid loan with Alberta Financial Service Corporation.
  • Advanced conversations with interested potential partners to utilize Ceapro’s innovative technologies.
  • Pursued out-licensing discussions for PGX-processed new chemical complexes.

Subsequent to Quarter:

  • Announced expansion of a grant from National Research Council of Canada for the optimization and mass production of yeast beta glucan as a potential inhalable therapeutic for COVID-19 and other fibrotic end-point disease of the lung.

Financial Highlights for the Third Quarter and Nine-Month Period Ended September 30, 2020

  • Total sales of $3,476,000 for the third quarter of 2020 and $12,415,000 for the first nine months of 2020 compared to $2,908,000 and $9,159,000 for the comparative periods in 2019. The 36% increase in sales for the first nine months is mainly due to a significant increase in sales of avenanthramides in the USA compared to the same period in 2019.
  • Net profit of $192,000 for the third quarter of 2020 and $2,395,000 for the first nine months of 2020 compared to a net loss of $104,000 and $1,299,000 for the comparative periods in 2019. An improvement of $3,694,000 for the nine-month period.
  • Excluding non-cash items, mainly amortization, adjusted net profit for the first nine months in 2020 is $ 4,035,000 versus adjusted net profit of $414,000 for the first nine months of 2019.
  • Cash flows generated from operations of $4,777,000 in 2020 vs $1,321,000 in 2019.
  • Positive working capital balance of $8,151,000 as of September 30, 2020.

“Looking ahead, while taking into account the ongoing potential economic impact related to COVID-19 and evolving consumption trends, we believe Ceapro is well-positioned to once again deliver a double-digit growth in sales well in line with the positive trend achieved over the last years. With a strong balance sheet, a group of dedicated people, and a solid base business, coupled with the innovative technologies and products that we have developed to enable us to expand, Ceapro is poised to emerge as a successful life science company,” concluded Mr. Gagnon.

The complete financial statements are available for review on SEDAR at https://sedar.com/Ceapro and on the Company’s website at www.ceapro.com.

About Ceapro Inc.

Ceapro Inc. is a Canadian biotechnology company involved in the development of proprietary extraction technology and the application of this technology to the production of extracts and “active ingredients” from oats and other renewable plant resources. Ceapro adds further value to its extracts by supporting their use in cosmeceutical, nutraceutical, and therapeutics products for humans and animals. The Company has a broad range of expertise in natural product chemistry, microbiology, biochemistry, immunology and process engineering. These skills merge in the fields of active ingredients, biopharmaceuticals and drug-delivery solutions.

For more information on Ceapro, please visit the Company’s website at www.ceapro.com.

For more information contact:

Jenene Thomas
JTC Team, LLC
Investor Relations and Corporate Communications Advisor
T (US): +1 (833) 475-8247
E: [email protected]

This press release does not express or imply that the Company claims its product has the ability to eliminate, cure or contain the SARS-2-CoV-2 (COVID-19) at this time.

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.

Source: Ceapro Inc.

Release – Noble Capital Markets, Inc. Announces Type-1 Diabetes Day- The Beginning of the End – Close to a Cure?

Noble Capital Markets, Inc. Announces Type-1 Diabetes Day- The Beginning of the End; Close to a Cure?

 

A Panel of World Experts Breaks it all Down in a Virtual Presentation

 

Boca Raton, Fla., Nov. 23, 2020 (VIA NEWSWIRE)  — Noble Capital Markets, Inc. (“Noble”) announced today that it will host Type-1 Diabetes Day where Dr. Camillo Ricordi and a world-class panel of T1D experts will discuss progress toward a functional cure. The virtual event “Type-1 Diabetes – The Beginning of the End; Close to a Cure?” is investor focused but will have broad appeal among all interested in the progress toward a functional cure for T1D. It is to be held November 24, 2020, at 12:30 online to all who register here.

Dr. Camillo Ricordi revolutionized a method of transplantation of islet cells (cells that produce insulin) 32 years ago. His method remains the gold standard today. The promise of overcoming one of the most challenging problems with any transplantation occurred when an anti-rejection antibody being explored for ALS was coupled with the transplantation. New islet cells had previously been rejected by the host. The anti-rejection antibody was key to this procedure jumping several steps closer to success.

The Panel will be moderated by Noble’s Nathan Cali, Managing Director, Head of Healthcare Investment and Merchant Banking, with a primary focus on the Novus Therapeutics, Inc. (NASDAQ:NVUS) – CD40/CD40L – FDA Phase II toxicity and efficacy trials and ongoing progress toward a functional cure with islet cell transplantation. The world-renowned panelists include:

  • Dr. Camillo Ricordi, Director of the Diabetes Research Institute at the University of Miami School of Medicine – Ranked as the World Leader in Islet Cell Transplant.
  • Dr. James Markmann, Chief of the Division of Transplant Surgery and Director of Clinical Operations at the Transplant Center at Massachusetts General Hospital, and the Claude Welch Professor of Surgery at Harvard Medical School.
  • Dr. Norma Sue Kenyon, Martin Kleiman Professor of Surgery, Microbiology and Immunology and Biomedical Engineering at the Diabetes research Institute.
  • Dr. David Gros, Chief Executive Officer Novus Therapeutics; Dr. Steven Perrin, President & CSO, Novus Therapeutics.
  • Eric Paslay, two-time Grammy award nominee country recording artist, & owner of The Country Note, a podcast featuring patients who battle diabetes.

November is Diabetes Awareness Month; this expert panel presentation will elevate awareness for investors and others interested in promising progress toward a functional cure for T1D.  The presentation is expected to last two hours and will be held at 12:30 PM (register to attend) on November 24, 2020. Attendance is open and at no cost to all who register for T1D-Day. As conference time is limited, Noble requests that only investment focused attendees participate by asking questions of the panelists. 

Who should attend Type-1 Diabetes Day?

Investors, including institutions, family offices, investment advisors, hedge funds, equity analysts, private equity & venture capital firms, independent brokers, wealth managers, and self-directed investors, will benefit from attending.

The subject is of interest to those within the investment community, medical practitioners and  others interested in the future of T1D. “Noble is proud of its part in the progression toward a cure,” said Nico Pronk, CEO/President of Noble, he added, “Although we had hoped to have an in-person conference featuring this panel, we’re taking advantage of the online platform and making sure many more who are interested in this subject can attend without the need to travel farther than their desktop.”

About Noble Capital Markets, Inc.

Noble Capital Markets  is a research-driven boutique investment bank that has supported small & micro-cap companies since 1984. As a FINRA and SEC licensed, broker-dealer Noble provides institutional-quality equity research, merchant and investment banking, wealth management, and order execution services. Noble launched channelchek.vercel.app – an investment community dedicated exclusively to small and micro-cap companies and their industries in 2018. Channelchek is tailored to meet the needs of self-directed investors and financial professionals. Channelchek is the first service to offer institutional-quality research to the public, for FREE at every level without a subscription. More than 6,000 public emerging growth companies are listed on the site, with growing content including research, webcasts, podcasts, and balanced news.

Registration: 

 https://register.gotowebinar.com/register/3215566146913039884

 

Contact:

Email: [email protected]

 

General Information:

www.noblecapitalmarkets.com

channelchek.vercel.app

Release – Lineage Cell Therapeutics (LCTX) – Video – Spinal Cord Injury Update

 

FORCE Webinar: Lineage Cell Therapeutics

 

Lineage CEO, Brian Culley and CFO, Brandi Roberts, talk about how their OPC1 Cell Therapy improves mobility after a severe spinal cord injury.

 

 

Lineage Cell Therapeutics (LCTX) – Takeaways from Expert call on OpRegen

Thursday, November 19, 2020

Lineage Cell Therapeutics (LCTX)

Takeaways from Expert call on OpRegen

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.

    OpRegen data update. Lineage conducted a therapeutics expert call on November 17th following data presentation at the 2020 American Academy of Ophthalmology Annual Meeting (AAO) on November 15, 2020. The data update was from eight Cohort 4 patients with better visual acuity enrolled in Phase 1/2a (NCT02286089) clinical study assessing the lead product candidate, OpRegen for the treatment of dry age-related macular degeneration (AMD) with geographic atrophy (GA).

    Interim showed encouraging signs.  Among the eight patients from Cohort 4 (better visual acuity VA, <= 20/64 and >= 20/250), four patients were treated with PPV and the other four with Orbit device. Orbit device seems to improve eye-related adverse events in this small number of patient population. 3/5 patients, 4/4, and 4/4 patients had improvements in standard ETDRS letter reads at month 6, 9, and …



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. 

Cocrystal Pharma Inc. (COCP) – Q3 EPS Pipeline Remains on Track

Tuesday, November 17, 2020

Cocrystal Pharma Inc. (COCP)

Q3 EPS: Pipeline Remains on Track

Cocrystal Pharma Inc is a clinical stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication machinery of influenza viruses, hepatitis C viruses, and noroviruses. The company employs structure-based technologies and Nobel Prize-winning expertise to create first-and best-in-class antiviral drugs. It is developing CC-31244, an investigational, oral, broad-spectrum replication inhibitor called a non-nucleoside inhibitor (NNI). CC-31244 is currently being evaluated in a Phase 2a study for the treatment of hepatitis C as part of a cocktail for ultra-short therapy of 4 to 6 weeks.

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

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

    Q3 2020 financial results. In 3Q, Cocrystal’s net loss was $2.7 million. In the 9-months of 2020, net loss was $8.1 million. The company ended the quarter with $31.8 million in cash and cash equivalents. Earnings per share (EPS) loss was ($0.05) in the quarter.

    Model update.  We updated our estimates, according to the reported numbers and reflecting the increase in operating expenses attributed to the additional clinical trial commencement. We now forecast $2.0 million, $2.1 million, and $2.4 million in revenues, $12.8 million, $14.5 million, and $15.8 million operating expenses, and ($0.20), ($0.18), and ($0.11) in EPS for F2020, F2021 and F2021 …



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. 

electroCore, Inc (ECOR) – 3Q Cost reduced Revenue Generation Continues

Monday, November 16, 2020

electroCore, Inc. (ECOR)

3Q: Cost reduced, Revenue Generation Continues

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 the preventative treatment of cluster headache and migraine and acute treatment of migraine and episodic cluster headache.

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

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

    3Q Results. electro’s 3Q20 results were uneventful. The company exited 3Q with $26 million in cash and marketable securities, which is expected to last through 2022. In the quarter, the company noted that it continues to generate revenue $1.1 million (+44% sequential growth compared to 2Q) with 2,881 total paid months of therapy (+17% compared to Q2). The net loss was $4.5 million with earnings per shares (EPS) of ($0.10) in the quarter.

    Model update.  We update our estimates to reflect slower revenue generation, reduce operating expenses, and shares outstanding. We now forecast $3.1 million, $6.5 million, and $10.7 million in revenues; ($0.62), ($0.45), and ($0.37) in EPS for F2020, F2021 and F2021, respectively. Our previous estimates were $4.7 million, $11.6 million, and $23.4 million in revenues and ($0.63), ($0.43), and ($0.22) …



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.