Helix Biopharma (HBPCF) – Q3 F2020 Earnings: More Value to Add in 2020

Wednesday, August 5, 2020

Helix Biopharma (HBPCF)(HBP:CA)

Q3 F2020 Earnings: More Value to Add in 2020

As of April 24, 2020, Noble Capital Markets research on Helix Biopharma is published under ticker symbols (HBPCF and HBP:CA). The price target is in USD and based on ticker symbol HBPCF. Research reports dated prior to April 24, 2020 may not follow these guidelines and could account for a variance in the price target.
Helix BioPharma Corp is a Canada-based clinical-stage biopharmaceutical company focused on cancer drug development. It develops therapies in the field of immuno-oncology based on its proprietary technology mainly in the areas of cancer prevention and treatment. The company has Tumor Defense Breakers (L-DOS47), and Tumor Attackers (CAR-T) product candidates in the pipeline.

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 F2020 financial results.  The company reported the third quarter fiscal year ended April 30, 2020. Net operating loss was $2.5 million for the quarter with $1.5 million research and development expenses and $0.9 million general and administrative expenses. Helix reported ($0.02) EPS.

    Updating estimates. We are adjusting our F2020 revenue and operating expense estimates. We have increased our R&D expenses to $6.4 million and reduced SG&A expense estimate to $2.7 million from $2.9 million. We are not expecting any pharma revenue this or next year. Previously we anticipated …



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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) – Promising Preclinical Data from Coronavirus Program

Wednesday, August 5, 2020

Cocrystal Pharma Inc. (COCP)

Promising Preclinical Data from Coronavirus Program

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.

    Coronavirus program preclinical study results are published. Cocrystal announced that animal study results of coronavirus antiviral compounds are published in Science Translational Medicine, one of the most prestigious medical journals. The publication highlights the mechanism action of the anti-viral compounds and the survival results of mice treated with these compounds. Cocrystal and Kansas State University Research Foundation (KSURF) have a license agreement. The publication highlights preclinical data of KSURF inhibitors.

    Anti-viral compounds reduced lung infection and increased survival in mice. The preclinical data suggest anti-viral compounds are protease inhibitors (3CLpro inhibitors) that are essential for viral replication. The lead compound reduces lung viral load and lung pathology and also prolongs the survival of infected mice. The data also emphasizes …



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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 – Ceapro Inc. Announces Publication of Positive Results from Study Evaluating Avenanthramides in Exercise-Induced Inflammation

 

Ceapro Inc. Announces Publication of Positive Results from Study Evaluating Avenanthramides in Exercise-Induced Inflammation

 

EDMONTON, ALBERTA – August 4, 2020Ceapro 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 that positive results demonstrating the anti-inflammatory and immunomodulating properties of avenanthramides have been accepted for publication in the international, peer-reviewed Journal of the International Society of Sports Nutrition. The article titled “Avenanthramide supplementation reduces exercise-induced inflammation in young men and women,” is now available online. The study was co-funded by Pepsi Co and Ceapro Inc.

Gilles Gagnon, M.Sc., MBA, President and CEO, commented “We are pleased with the results from the work conducted by the team led by Dr. Li Li Ji and Dr. Zhang at the University of Minnesota and to have these positive results accepted for publication in this internationally renowned Journal. The acceptance of these data for publication bolster both our confidence in our flagship product avenanthramides and our belief in the potential Ceapro has in expanding into a biopharmaceutical company. These studies, while they were conducted using avenanthramides in food, provide a solid foundation for our research team as they move forward and conduct a safety and bioavailability study using proprietary, pure pharmaceutical-grade powder formulation of avenanthramides. The safety and bioavailability study will evaluate avenanthramides as a stand-alone therapy or potentially in combination with carriers recently developed using our PGX technology to address some inflammation-based diseases, which we believe shows great promise.”

The published results were presented by Dr. Tianou Zhang MD, PhD at the 2019 Annual World Congress of the American College of Sports Medicine (ACSM).

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]

Issuer:

Gilles R. Gagnon, M.Sc., MBA
President & CEO
T: 780-421-4555

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

Release – Cocrystal Pharma Announces Publication of Positive Data Demonstrating Potent In Vitro Inhibition Against Coronavirus

 

Cocrystal Pharma Announces the Publication by Collaborators of Positive Data Demonstrating Potent In Vitro Inhibition Against Coronavirus in Science Translational Medicine Journal

– Cocrystal has two exclusive licenses for the coronavirus protease inhibitors described in the publication –
– Cocrystal is currently further conducting preclinical studies of these coronavirus protease inhibitors (3CL) –

BOTHELL, WA, August 4, 2020 – Cocrystal Pharma, Inc. (NASDAQ: COCP), (“Cocrystal” or the “Company”), a clinical stage biotechnology company discovering and developing novel antiviral therapeutics, today announced the publication of preclinical animal studies of coronavirus antiviral compounds in the renowned medical journal, Science Translational Medicine.

The manuscript titled, “The 3C-like protease inhibitors with potent in-vitro inhibition against SARS-CoV-2 and therapeutic efficacy in MERS-CoV infected mice,” was published online in the 3 August 2020 Science Translational Medicine Journal. Authors of the published manuscript were Athri D. Rathnayake, Jian Zheng, Yunjeong Kim, Krishani Dinali Perera, Samantha Mackin, David Meyerholz, Maithri M. Kashipathy, Kevin P. Battaile, Scott Lovell, Stanley Perlman, William C. Groutas, Kyeong-Ok Chang.

Data presented in the publication is included in the Company’s two exclusive license agreements with Kansas State University Research Foundation (“KSURF”) for new coronavirus antiviral compounds with novel mechanism of action.

“Our license agreement with KSURF has continued to exhibit the potential and broad utility of our platform to address the SARS-CoV-2 virus responsible for the COVID-19 worldwide pandemic. To have this compelling data included in the prestigious publication, Science Translational Medicine, is a testament to the potential of these inhibitors to treat COVID-19. The publication supports the quality and importance of the work performed by the group of co-authors,” commented Dr. Gary Wilcox, Chairman and Chief Executive Officer of Cocrystal.

Under the license agreements with KSURF, Cocrystal has been granted an exclusive, royalty-bearing right and license to certain antiviral compounds for humans and small molecule therapeutic inhibitors against coronaviruses, picornaviruses and caliciviruses covered by patent rights controlled by KSURF. Cocrystal intends to continue development of these antiviral compounds for coronavirus. These licenses significantly expand and further advance the Company’s COVID-19 program by providing more targeted and potent compounds.

“We are incredibly enthusiastic with the positive preclinical data and the solid foundation we believe these inhibitors provide for advancing development of SARS-CoV-2 treatment,” added Dr. Sam Lee, President of Cocrystal. “The potent activity and the effectiveness of the mechanism of action demonstrated by these coronavirus protease inhibitors is very encouraging. Of utmost interest was the activity seen from a select number of compounds in the study series which were shown to be effective in vitro against SARS-CoV-2. In addition, we continue applying our proprietary platform technology to further optimize properties of lead molecules and are also exploring multiple routes of administration of these COVID-19 antivirals. These findings bolster our belief in the broad-spectrum capabilities and demonstrated proof-of-concept therapeutic efficacy of these inhibitors against human and animal coronaviruses.”

Cocrystal initiated its preclinical studies of COVID-19 inhibitors received from KSURF during Q2 2020. The Company has also recently identified additional inhibitors using its proprietary platform technology and anticipates the selection of its lead preclinical molecule by year end.

About Science Translational Medicine

Science Translational Medicine is a weekly journal devoted to research and issues of strong interest to the translational medicine community. Translational medicine topics suitable for submission include any original research findings, discussions or analyses that move the field closer to the goal of improving human health, or the diagnosis and treatment of disease.

Science Translational Medicine publishes original, peer-reviewed, science-based research articles that report successful advances toward the goal of improving patients’ lives. The editors and an international advisory group of scientists and clinician-scientists as well as other experts hold Science Translational Medicine articles to the same high-quality standard that is the hallmark of the journal Science.

About Coronavirus Disease 2019 (COVID-19)

COVID-19 is caused by a coronavirus called SARS-CoV-2. Coronaviruses are a large family of viruses that are common in people and many different species of animals, including camels, cattle, cats, and bats. Rarely, animal coronaviruses can infect people and then spread between people. This occurred with MERS-CoV and SARS-CoV, and now with the virus that causes COVID-19.

The virus that causes COVID-19 is thought to spread mainly from person to person, mainly through respiratory droplets produced when an infected person coughs or sneezes. These droplets can land in the mouths or noses of people who are nearby or possibly be inhaled into the lungs. Spread is more likely when people are in close contact with one another (within about 6 feet).

COVID-19 seems to be spreading easily and sustainably in the community (“community spread”) in many affected geographic areas. Community spread means people have been infected with the virus in an area, including some who are not sure how or where they became infected.

Summary updates are available on CDC’s web page: Coronavirus Disease 2019 (COVID-19).

About Cocrystal Pharma, Inc.

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

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to expected results of our collaboration with Merck, including the potential of the Company’s platform to address the virus responsible for and treat COVID-19, the Company’s continued development of its licensed antiviral compounds ; and the anticipated timing of achieving the value-driving milestones in our COVID-19 program, including the selection of a preclinical lead molecule in Q4 2020. The words “believe,” “proceeds,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks arising from the impact of the COVID-19 pandemic on our Company, including (i) supply chain disruptions, (ii) our continued ability to proceed with our programs, and (iii) on the national and global economy, our reliance on certain third parties, and competition from major pharmaceutical and biotechnology companies which are advancing product candidates to treat COVID-19 and related vaccines. Further information on our risk factors is contained in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2019. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Additional factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.

Investor and Media Contact:
JTC Team, LLC
(833) 475-8247
[email protected]

A Kodak Moment – Shares Rose as Much as 650 Percent

A Positive COVID-19 Response: From Photos to Pharmaceuticals Drives KODK

On July 27th, the U.S. International Development Finance Corporation signed a letter of intent to provide a $765 million loan to Eastman Kodak Company to support the launch of Kodak Pharmaceuticals. Kodak Pharmaceuticals will produce critical pharmaceutical components that have been identified as essential but have lapsed into chronic national shortage, according to the release. Just 10% of the bulk components used to produce generic pharmaceuticals are produced in the U.S. Fully operational, Kodak Pharmaceuticals will have the capacity to produce up to 25% of active pharmaceutical ingredients used in non-biologic, non-antibacterial generic pharmaceuticals.

COVID Market Mania

Although one does not really think of pharmaceuticals and Kodak together, during the pandemic, the company, using its expertise in chemicals and advanced materials, has shifted some of its production capacity to making isopropyl alcohol for hand sanitizer and face masks using the company’s ESTAR film base.

On the news, KODK shares jumped more than 200% Tuesday and were up 318% Wednesday. At one point during the day Wednesday, the shares were up 650%. After trading in the $2-$4 range since mid-2019, KODK shares soared as high as $60 before closing Wednesday at $33.20. The shares rose so fast on Wednesday, they tripped 20 NYSE circuit breakers!

Chart shows increased Robinhood user’s holding vs. price of $KODK, June 1 through morning of August 3, 2020.  Source: Robintrack

Small Online Traders Add Up

Volume went from a normal couple hundred thousand shares per day to over 275 million shares on both Tuesday and Wednesday, or six times the actual number of outstanding shares.

Robinhood traders were actively involved in the frenzy — The number of Robinhood accounts holding KODK shares exploded from under 10,000 on Monday to over 119,000 on Wednesday.

It’s Early

Although the announcement has generated a nearly unprecedented feeding frenzy, sometimes the Devil is in the details and it pays to read the fine print. Kodak and the International Development Corporation (DFC) only signed a Letter of Intent. The LOI indicates Kodak has successfully completed DFC’s initial screening but will be followed by standard due diligence before financing is formally committed. Second, it will take three
and a half years
to build out the new production capacity, according to Kodak CEO Jim Continenza.

 

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Sources:

  1. https://www.dfc.gov/media/press-releases/dfc-sign-letter-interest-investment-kodaks-expansion-pharmaceuticals?CID=exit&idhbx=dfcrelease
  2. https://www.kodak.com/en/company/press-release/q1-2020-financial-results
  3. https://www.cnn.com/2020/07/29/investing/kodak-stock-rally-defense-protection-act/index.html
  4. https://markets.businessinsider.com/news/stocks/kodak-stock-price-movement-after-skyrocketing-1200-percent-2-days-2020-7-1029450808#
  5. https://seekingalpha.com/article/4362200-eastman-kodak-trump-administration-bailout-sparks-epic-rally-get-short-momentum-starts-to
  6. https://seekingalpha.com/article/4361685-eastman-kodak-resurrects-covidminus-19-play
  7. https://seekingalpha.com/article/4346858-eastman-kodak-company-kodk-on-q1-2020-results-earnings-call-transcript?part=single

 

Onconova Therapeutics (ONTX) – Preliminary Data Is Expected In Q3 2020 Following Required Number Of Survival Events Reached

Thursday, July 30, 2020

Onconova Therapeutics Inc. (ONTX)

Preliminary Data Is Expected In Q3 2020 Following Required Number Of Survival Events Reached

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.

    Required number of survival events reached in the INSPIRE trial.  Yesterday, Onconova announced that the required number of survival events has been reached for the pivotal Phase 3 INSPIRE trial data analysis. The company plans to provide preliminary top-line data in Q3 2020 and full top-line data at a medical conference in Q4 2020 -potentially at the Annual American Society of Hematology (ASH) meeting in December 2020.

    What does this mean for the company? Based on this news, the company’s guidance of INSPIRE data is on track to read out in H2 2020. The median survival rate of high-risk MDS patients who failed azacytidine treatment is 5.6 months. The primary endpoint assessment was set to start dependent on this targetted survival event …




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

*Analyst
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NOTE: investment decisions should not be based upon the content of
this research summary.  Proper due diligence is required before
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Onconova Therapeutics Inc. (ONTX) – What is going on with Onconova?

Wednesday, July 29, 2020

Onconova Therapeutics Inc. (ONTX)

What is going on with Onconova?

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.

    Funding application to use rigosertib against coronavirus infection. This week, Onconova has submitted an application to the National Institute of Allergy and Infectious Disease (NIAID), to obtain funding from the National Institutes of Health (NIH) to conduct human studies with rigosertib for the treatment of COVID-19 disease. The company plans to pursue clinical studies upon a positive funding decision.

    What does it mean? The company plans to pursue clinical studies only upon a positive funding decision. While it is not easy to predict the NIAID’s decision to fund rigosertib to treat coronavirus infection, Onconova does not intend to pursue clinical development without additional sources. A favorable decision would …




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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
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Release – Helix BioPharma Virtual Town Hall 2020-07-29

 

Virtual Town Hall
Wednesday, July 29nd 2020 @ 12:00pm EST

 

You are cordially invited to attend Helix BioPharma presenting at the AlphaBronze Virtual Town Hall, taking place on Wednesday, July 29nd at 12:00pm EST

 

Helix BioPharma – Town Hall Agenda

CEO Presentation – 10 to 15 minutes

Follow-up Q&A – 10 to 15 minutes

 

REGISTER

https://zoom.us/webinar/register/WN_0tdX0OQrTuS_gJCk53zVTQ

 

After registering, you will receive a confirmation email containing information about joining the webinar.

For more information on Helix BioPharma: https://www.helixbiopharma.com

 

Speaker – CEO Dr. Heman Chao

Dr. Chao will give an overview of the Company, its Lung Cancer and Pancreatic Cancer Clinical programs and upcoming milestones. Dr. Chao will respond to Investors questions thereafter.

Helix BioPharma Corp. (TSX: HBP) is a clinical-stage biotech, focused on immuno-oncology. The biotech is specializing in the field of cancer therapy and actively developing innovative products for the prevention and treatment of cancer based on its proprietary technologies, DOS47. Its patented oncology platform technology – DOS47 – offers a new and revolutionary approach to the debilitation and destruction of cancer cells by modulating the tumor microenvironment.

Founded in 1995, Helix BioPharma is based in Toronto. Helix Clinical Trials and programs’ focus are on Lung and Pancreatic cancer. In December 2019, it started patient’s enrollment for its L-DOS47 Phase lb/ll Pancreatic Cancer Clinical Study. Pancreatic cancer is an important cause of cancer death in the US – with few treatment options.

PSCs Can Function Like Embryonic Stem Cells

Are Pluripotent Stem Cell Based Therapies Close to Market?

The history of deriving embryonic stem cells from mice goes back to its discovery in 1981. This was followed by a decade of research on mouse stem cell biology, which led scientists to find a method to derive stem cells from human embryos. In 1998 they developed a method to grow them in a laboratory setting. This was followed by another breakthrough in 2006; the identification of conditions allowing some specialized adult cells to be genetically reprogrammed to assume a stem cell-like state. These cells are called induced pluripotent stem cells (iPSCs). Shinya Yamanaka (Kyoto University, Japan and Gladstone Institutes, USA) and John Gurdon (Gurdon Institute, Cambridge, UK) received the Nobel Prize for Physiology or Medicine for the discovery of mature cells reprogrammed into a pluripotent state in 2012.

Many discoveries and milestones in the field ushered in a transition from fundamental research to pre-clinical research, and then to clinical trials. The history of stem cell research is highlighted in Exhibit 1. PSCs entered into the clinic first for the treatment of advanced macular degeneration in 2017 (Mandai et al. 2017).

Exhibit 1. The history of stem cell research

Source: Stem Cell Rev and Rep (2020) 16:3 –32

PSCs can function like embryonic stem (ES) cells and have the ability to differentiate or develop into a variety of specific cell types in the body, such as liver cells, muscle cells, blood cells (Exhibit 2). Stem-cell-based therapeutics is widely considered as a promising and exciting arena in medicine attributed to their capability of regenerating and repairing damaged tissues.

Exhibit 2. Stem cells can differentiate into any type of
cell in the body

 

Source: SM. Afify et al. Cancers 2019, 11, 345

The transplantation into patients presents unique safety risks of human PSC (hPSC)-derived cell therapies. The major risks include i) hPSC differentiation yielding to a heterogeneous cell population, ii) residual undifferentiated hPSCs (10,000 or even fewer) forming a teratoma (a tumor made up of several different types of tissue, such as hair, muscle, teeth, or bone).

Exhibit 3. Safety risks of pluripotent cell-based
therapies

Source: RM. Martin ET AL. Nature Communications, (2020) 11:2713

Many hurdles and limitations in the production of clinical-grade embryonic stem cells (ESC) and iPSC derivatives have since been overcome. These cells can now be expanded in scalable suspension culture, a targeted, robust, and efficient differentiation of human ESCs and iPSCs can be achieved via inhibition and activation of molecular differentiation pathways.

Over the past 20 years, significant developmental milestones have driven basic, translational, and clinical advances in the fields of stem cells and regenerative medicine. Over the past decade, human pluripotent stem cell (hPSC)- derived cell therapies have been assessed in over 30 ongoing or completed clinical trials for various indications -including spinal cord injury, macular degeneration, and type 1 diabetes. Due to the immune privilege, the vast majority of the current clinical trials on transplantation of PSC-based cell products aim to treat macular degeneration. The eye is an “immune privileged” site. This phrase was defined by Peter Medawar and colleagues in the 1940s following the skin allografts placed within the anterior chamber of the eye surviving indefinitely, while their rapid rejection in other tissues such as the skin. The ocular microenvironment is highly anti-inflammatory. Multiple factors -such as proteins, neuropeptides, and biochemicals- modify the behavior, differentiation, and survival of immune cells within the ocular microenvironment promoting an anti-inflammatory, immune response, and induction of immune tolerance, which protects the eye from the irreversible collateral damage of inflammation that can lead to blindness.

Cellular therapies based on iPSCs are considered innovative but complex therapeutic concepts. The human pluripotent stem cell (hPSC)- derived cell therapies have rapidly expanded potential as therapeutics; however, they continue to carry safety risks. The scientific community has teamed up for the development of therapeutic applications and cellular products. The identification of the right patient population/indication and discovery of the optimum delivery route are crucial components for successful hPSC-derived cell therapy. Considering the scientific advancement in the genome editing approaches to the platform’s engineering, imaging, and other research and clinical tools, it may be a matter of time for hPSC-derived cell therapies to become a reality and lead to another breakthrough in medicine.

 

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Genprex (GNPX) – NIH Grant Provides Validation for Diabetes Program

Wednesday, July 22, 2020

Genprex Inc.(GNPX)

NIH Grant Provides Validation for Diabetes Program

Genprex Inc is a U.S.-based clinical-stage gene therapy company. It is engaged in developing a new approach to treating cancer based on its novel proprietary technology platform, including initial product candidate, Oncoprex immunogene therapy. Oncoprex, which has a multimodal mechanism of action whereby it interrupts cell signaling pathways that cause replication and proliferation of cancer cells, re-establishes pathways for apoptosis in cancer cells and modulates the immune response against cancer cells.

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

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

    Awarded an NIH Grant. Yesterday, Genprex (GNPX) announced that a grant of $2.59 million awarded to the company by the National Institutes of Health (NIH) National Institute of Diabetes and Digestive and Kidney Diseases. This grant will fund the ongoing preclinical research for proof-of-principle studies in preparation for human gene therapy clinical trials of GPX-002 in type 1 diabetes.

    Diverse portfolio with large market potential. Genprex’s lead drug candidate Oncoprex is currently being evaluated in combination with erlotinib for the treatment of non-small cell lung cancer (NSCLC) in Phase 2 clinical study. The company plans to assess Oncoprex in combination with Tagrisso and Keytruda, the trials are expected to commence in the next …



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

*Analyst
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NOTE: investment decisions should not be based upon the content of
this research summary.  Proper due diligence is required before
making any investment decision.
 

NIH Awards Research Grant for Diabetes Gene Therapy Technology Licensed by Genprex

National Institutes of Health (NIH) Awards Research Grant of $2.59 Million to University of Pittsburgh for Diabetes Gene Therapy Technology Licensed by Genprex

AUSTIN, Texas — (July 21, 2020) — Genprex, Inc. (“Genprex” or the “Company”) (NASDAQ: GNPX), a clinical-stage gene therapy company developing potentially life-changing technologies for patients with cancer and diabetes, today announced that Dr. George K. Gittes, MD of the University of Pittsburgh, the lead researcher that developed the Company’s potentially curative diabetes gene therapy, was awarded a grant of $2.59 million from the National Institutes of Health (“NIH”) National Institute of Diabetes and Digestive and Kidney Diseases. The grant will assist Dr. Gittes’s development for his research project titled, “Alpha Cell Conversion to Beta Cells in Non-human Primates” and will build upon his accumulating groundbreaking gene therapy work toward finding a cure for diabetes. In this project, Dr. Gittes’ research team will conduct important proof-of-principle studies in non-human primates as the last steps in preparation for human gene therapy clinical trials. This technology is the subject of an exclusive license agreement entered into between Genprex and the University of Pittsburgh in February of 2020.

“We are excited to receive this funding to support our research in diabetic primates as we move toward human clinical trials,” said Dr. George Gittes, Co-Scientific Director and Professor of Surgery at the UPMC (University of Pittsburgh Medical Center) Children’s Hospital of Pittsburgh and the lead researcher behind the diabetes gene therapy. “We saw encouraging data in our preclinical mice studies, where the gene therapy reprogrammed pancreatic cells to restore normal blood glucose levels in diabetic mice for approximately four months, which could translate to decades in humans. More recently, preliminary results in non-human primates (monkeys) has also been very promising.”

Dr. Gittes’ gene therapy for diabetes, which Genprex refers to as “GPX-002,” uses a novel infusion process comprised of an endoscope and an adeno-associated virus (AAV) vector to deliver Pdx1 and MafA genes to the pancreas. The genes express proteins that transform alpha cells in the pancreas into functional beta-like cells, which can produce insulin but are distinct enough from beta cells to evade the body’s immune system.

Diabetes affects approximately 10 percent of the U.S. population, or more than 34 million people. The diabetes gene therapy could not only become a new treatment option for millions of diabetes patients who need insulin replacement therapy, but it holds the potential to provide long-term effectiveness, or may even be a cure, for diabetic patients.

Dr. Gittes is the inventor of the gene therapy for diabetes, and he is eligible to receive royalties on this technology in the future.

About Genprex, Inc.

Genprex, Inc. is a clinical-stage gene therapy company developing potentially life-changing technologies for patients with cancer and diabetes. Genprex’s technologies are designed to administer disease-fighting genes to provide new treatment options for large patient populations with cancer and diabetes who currently have limited treatment options. Genprex works with world-class institutions and collaborators to in-license and develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches. The Company’s lead product candidate, GPX-001 (quaratusugene ozeplasmid), is being evaluated as a treatment for non-small cell lung cancer (NSCLC). GPX-001 has a multimodal mechanism of action that has been shown to interrupt cell signaling pathways that cause replication and proliferation of cancer cells; re-establish pathways for apoptosis, or programmed cell death, in cancer cells; and modulate the immune response against cancer cells. GPX-001 has also been shown to block mechanisms that create drug resistance. In January 2020, the U.S. Food and Drug Administration granted Fast Track Designation for GPX-001 for NSCLC in combination therapy with osimertinib (AstraZeneca’s Tagrisso®) for patients with EFGR mutations whose tumors progressed after treatment with osimertinib alone. For more information, please visit the Company’s web site at www.genprex.com or follow Genprex on Twitter, Facebook and LinkedIn.

The project described in this press release is being supported by the National Institute of Diabetes and Digestive And Kidney Diseases of the National Institutes of Health under Award Number R01DK120377. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the effect of Genprex’s product candidates, alone and in combination with other therapies, on cancer and diabetes, regarding potential, current and planned clinical trials, regarding the Company’s future growth and financial status and regarding our commercial partnerships and intellectual property licenses. Risks that contribute to the uncertain nature of the forward-looking statements include the presence and level of the effect of our product candidates, alone and in combination with other therapies, on cancer; the timing and success of our clinical trials and planned clinical trials of GPX-001, alone and in combination with targeted therapies and/or immunotherapies, and whether our other potential product candidates, including GPX-002, our gene therapy in diabetes, advance into clinical trials; the success of our strategic partnerships, including those relating to manufacturing of our product candidates; the timing and success at all of obtaining FDA approval of GPX-001 and our other potential product candidates including whether we receive fast track or similar regulatory designations; costs associated with developing our product candidates and whether patents will ever be issued under patent applications that are the subject of our license agreements. These and other risks and uncertainties are described more fully under the caption “Risk Factors” and elsewhere in our filings and reports with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. We undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Genprex, Inc.
(877) 774-GNPX (4679)

Investor Relations
GNPX Investor Relations
(877) 774-GNPX (4679) ext. #2
[email protected]

Media Contact
Genprex Media Relations
(877) 774-GNPX (4679) ext. #3
[email protected]

TherapeuticsMD (TXMD) – Expanded Patient Access of Annovera

Wednesday, July 15 2020

TherapeuticsMD Inc. (TXMD)

Expanded Patient Access of Annovera

(current) TherapeuticsMD, Inc. is a women’s healthcare company focused on developing and commercializing products targeted exclusively for women. It manufactures and distributes branded and generic prescription prenatal vitamins, as well as over-the-counter vitamins and cosmetics, under our vitaMedMD’ and BocaGreenMD’ brands. The company is currently developing advanced hormone therapy pharmaceutical products designed to alleviate the symptoms of and reduce the health risks resulting from menopause-related hormone deficiencies. It is also evaluating various other potential indications for our hormone technology, including oral contraception, preterm birth, vulvar and vaginal atrophy, and premature ovarian failure.

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

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

    Expanding access to Annovera. TherapeuticsMD announced expansion of agreement with Nurx, the largest online practice for women’s health. Under this arrangement, Nurx will expand access to 300,000 patients across the country to TherapeuticsMD’s annual birth control ring Annovera.

    Meaningful development. Annovera net sales were $2.3 million in Q1 2020, the patient demand doubled compared to Q4 2019. In our opinion, Annovera’s access to Nurx patients will generate meaningful revenue for the company, in spite of Covid-19’s halt on …




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This 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.
 

Dyadic (DYAI) – Another Pharmaceutical Partnership is Established

Wednesday, July 15, 2020

Dyadic International Inc. (DYAI)

Another Pharmaceutical Partnership is Established

Dyadic International, Inc. is a global biotechnology company which is developing what it believes will be a potentially significant biopharmaceutical gene expression platform based on the industrially proven hyper productive engineered fungus Thermothelomyces heterothallica (formerly Myceliophthora thermophila), named C1.
The C1 microorganism, which enables the development and large scale manufacture of low cost proteins, has the potential to be further developed into a safe and efficient expression system that may help speed up the development, lower production costs and improve the performance of biologic vaccines and drugs at flexible commercial scales. Dyadic is using the C1 technology and other technologies to conduct research, development and commercial activities for the development and manufacturing of human and animal vaccines and drugs, such as virus like particles (VLPs) and antigens, monoclonal antibodies, Fab antibody fragments, Fc-Fusion proteins, biosimilars and/or biobetters, and other therapeutic proteins. Dyadic pursues research and development collaborations, licensing arrangements and other commercial opportunities with its partners and collaborators to leverage the value and benefits of these technologies in development and manufacture of biopharmaceuticals. In particular, as the aging population grows in developed and undeveloped countries, Dyadic believes the C1 technology may help bring biologic vaccines, drugs and other biologic products to market faster, in greater volumes, at lower cost, and with new properties to drug developers and manufacturers, and improve access and cost to patients and the healthcare system, but most importantly save lives.

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

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

    Dyadic added one more pharma collaboration to it’s partnership portfolio. Dyadic has established multiple research collaborations assessing C1 technology to manufacture various biologic products including Fc-fusion proteins, monoclonal antibodies, Fabs, bi or tri-specifics, gene therapy, vaccines, and others. The company established an additional partnership with a top 5 pharmaceutical company.

    Favorable risk/reward profile. We believe these partnerships provide a favorable risk/reward profile for the C1 platform. Similar to others, this partnership is also a fully-funded research collaboration. The partners are responsible for the research costs evaluating C1 technology. These partnerships increase …



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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.