Ceapro Inc. Reports 2020 Second Quarter and Six-Month Financial Results and Operational Highlights
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– First milestone successfully achieved in early stages of the ongoing research project with McMaster University
– Confirmed capability of PGX Technology to optimize and standardize the size and morphology of yeast beta-glucan (PGX-YBG) suitable for lung inhalation
– In-vitro study with human cell lines demonstrated that PGX-YBG obtained from different sources exhibited significant stimulatory effect on human immune response
EDMONTON, ALBERTA – August 18, 2020 – 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 provided an update on its ongoing collaboration with McMaster University to develop an inhalable therapeutic for COVID-19.
The project, entitled “PGX-processed yeast beta-glucans as an inhalable immunomodulating therapeutic for COVID-19 patients,” jointly funded by Mitacs and Ceapro, is under the leadership of Dr. Kjetil Ask, a pulmonary fibrosis expert, and Dr. Todd Hoare respectively from departments of Medicine and Chemical Engineering at McMaster University.
To assess the potential of PGX-processed yeast beta-glucan (PGX-YBG) in practical application for COVID-19, the project was designed with four aims or milestones. The first milestone was to optimize the size and morphology of the best PGX-YBG for immunomodulation while the second milestone was to examine tolerability and safety of inhaled PGX-YBG in naïve animal models. The first milestone of the project was fully achieved, and the second milestone is near completion.
In order to derive the best and most suitable PGX-YBG product, the PGX Research and Development (R&D) Team at Ceapro worked very diligently to source, fractionate, and modify the PGX demo unit to process yeast beta glucan obtained from various sources. Surface area, surface morphology and particle size distribution measurements conducted by Ceapro and the research team at McMaster confirmed that, unlike the yeast beta-glucan currently available on the market, the PGX-processed YBG particles consistently generated from the retained raw material are small enough for effective inhalation.
“We are excited that we have been able to fabricate particles that have the targeted properties for inhalation, enabling the effective delivery of the particles to patients’ lungs pending the safety and efficacy animal trials now underway. As this project continues, our confidence in the potential of Ceapro’s materials to treat late-stage COVID-19 patients
and make a real-time impact on preserving lives during the pandemic continues to build,” reported Dr. Todd Hoare.
Dr. Kjetil Ask added, “If this size optimized PGX-YBG passes the tolerability, safety and therapeutic animal tests that we have already initiated, this material could quite quickly contribute as an immune modulator and anti-fibrotic treatment option for the most severe COVID-19 patients. Additionally, and equally exciting, the possibility of using PGX-YBG as an inhalable carrier of other drugs, would potentially allow the direct delivery of additional treatment options and increase their bioavailability in the lung, while reducing potential side effects.”
In parallel to the animal studies conducted at McMaster University, Ceapro also outsourced an in-vitro study to assess the immune response of the PGX-YBG on human receptors. The activity of PGX-YBG was tested on two human Dectin isotypes (Dectin-1a and Dectin-1b) involved in the modulation of the innate human immune response. The conclusion of this in-vitro study was that PGX-YBG exhibited significant stimulatory effect on human Dectin-1a and Dectin-1b receptors. Due to the results seen in the in-vitro study, the Company expects that PGX-YBG will stimulate the human immune response once inhaled into the lungs and potentially prevent reactions like the cytokine storm. The results demonstrated in the in-vitro study were also consistent with results seen in the preliminary biological study where PGX-YBG was found to modulate the immune system without causing the undesirable side-effects associated with other yeast beta-glucan.
“We are very proud of the work that has been conducted so far and believe we are well-positioned to offer an additional tool in the fight against COVID-19, which is having devastating effects worldwide. With the expected completion of the third and fourth goals related to tolerability, safety and efficacy studies with both naïve and pre-clinical animal models as early as mid-October, our teams are positioning us to be ahead of schedule. Hoping for favorable pre-clinical results, preparations of a Phase 1/2 clinical trial protocol will be commenced immediately and planned to be submitted to Health Authorities during Q4 2020. Given that yeast beta-glucan is already approved as a pharmaceutical additive, we expect to quickly develop PGX-YBG as a fast-acting inhalable stand-alone therapeutic and/or delivery system to treat severe inflammation observed in COVID-19 patients and other fibrotic end-point disease in the lung,” commented Gilles Gagnon, M.Sc., MBA, President and CEO of Ceapro. “We look forward to providing continued updates as we progress through the next milestones of this study.”
About Pressurized Gas eXpanded Liquid Technology (PGX)
Ceapro’s patented Pressurized Gas eXpanded (PGX) is a unique and disruptive technology with several key advantages over conventional drying and purification technologies that can be used to process biopolymers into high-value, fine-structured, open-porous polymer structures and novel biocomposites. PGX is ideally suited for processing challenging high-molecular-weight, water-soluble biopolymers. It has the ability to make ultra-light, highly porous polymer structures on a continuous basis, which is not possible using today’s conventional technologies. PGX was invented by Dr. Feral Temelli from the Department of Agricultural, Food & Nutritional Science of the University of Alberta (U of A) along with Dr. Bernhard Seifried, now Senior Director of Engineering Research and Technology at Ceapro. The license from U of A provides Ceapro with exclusive worldwide rights in all industrial applications.
About McMaster University
McMaster University, one of four Canadian universities listed among the Top 100 universities in the world, is renowned for its innovation in both learning and discovery. It has a student population of 23,000 and more than 175,000 alumni in 140 countries.
About Mitacs
Mitacs is a national, not-for-profit organization that has designed and delivered research and training programs in Canada for 20 years. Working with over 100 post-secondary institutions, 6,000 companies, and both federal and provincial governments, Mitacs builds partnerships that support industrial and social innovation in Canada.
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: czo@jtcir.com
Issuer:
Gilles R. Gagnon, M.Sc., MBA
President & CEO
T: 780-421-4555
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.
Friday, August 14, 2020
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.
Q2 earnings reported. Dyadic announced Q2 2020 earnings results yesterday. In the second quarter, research and development (R&D) revenue was $524,000, increased 66% compared to the previous quarter, attributed to the new research collaborations. R&D expenses were $1.81 million and general and administrative expenses were $1.48 million in the quarter. The net loss was $2.65 million or $0.10 per share. Our estimates are in line with the reported numbers. We are maintaining our F2020 estimates of $1.77 million revenue and $11.6 million operating expenses including $5.8 million R&D and $5.8 million SG&A expenses. We forecast ($0.32) EPS.
Multiple milestones achieved in the quarter. Dyadic established multiple research collaborations with companies and institutions to develop vaccine and antibody to combat coronavirus. The partners include Frederick National Laboratory, Israel Institute for Biologic Research (IIBR), EU ZAPI initiative, Ufovax, and others. The company also …
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JUPITER, FL / ACCESSWIRE / August 13, 2020 / Dyadic International, Inc. (“Dyadic”) (NASDAQ:DYAI), a global biotechnology company focused on further improving, applying and deploying its proprietary C1 gene expression platform to accelerate development, lower production costs and improve the performance of biologic vaccines and drugs at flexible commercial scales, today announced its financial results for the quarter ended June 30, 2020, and recent developments.
“We have made terrific progress on multiple fronts in the second quarter – further advancing and strengthening our diverse and growing portfolio of opportunities by adding new top tier collaborations in both the animal and human health fields. We are expanding our commercial reach in large and growing addressable markets while continuing to report exciting and new scientific data and progress. These developments reinforce the broad application potential of our C1 technology as well as some of its key attributes including high productivity and low cost of goods,” said Mark Emalfarb, Dyadic’s Chief Executive Officer.
“In response to COVID-19, we have taken the necessary health and safety measures to protect our employees, lab teams and partners around the world who, for the most part, have been working remotely. We are fortunate that beyond those changes in the way we conduct our daily work, COVID-19 has had a minimal impact on the Company’s ability to continue our progress,” Mr. Emalfarb concluded.
“The continued growth of our Company has added to our visibility in the investment community with our recent inclusion in the Russell 2000 and 3000 indices providing us the opportunity to further broaden our shareholder base. Our management team remains highly energized by the significant number of opportunities available to us, supported by best in-class scientific partners, our on-going R&D collaborations funded partially or fully by our partners, and our active and diverse pipeline of potentially high return projects.” said Michael Tarnok, Dyadic’s Board Chairman.
RECENT DEVELOPMENTS
As a result of the Company’s extensive business development activities, the management anticipates closing additional collaborations with other top tier human pharmaceutical companies by the end of 2020, working toward the Company’s goal of becoming a platform of choice for manufacturing protein-based biologics.
SCIENTIFIC ACHIEVEMENTS
FINANCIAL RESULTS
FOR THE THREE MONTHS ENDED JUNE 30, 2020
At June 30, 2020, cash and cash equivalents were approximately $11.8 million compared to $4.8 million at December 31, 2019. The carrying value of short-term and long-term investment grade securities, including accrued interest at June 30, 2020, was approximately $20.3 million compared to $31.2 million at December 31, 2019.
Research and development revenue for the quarter ended June 30, 2020, increased to approximately $524,000 compared to $391,000 for the quarter ended June 30, 2019. Cost of research and development revenue for the quarter ended June 30, 2020 increased to approximately $624,000 compared to $322,000 for the quarter ended June 30, 2019. The increase in revenue and cost of research and development revenue for the quarter ended June 30, 2020 reflected nine on-going research collaborations compared to four collaborations for the same period a year ago. The increase in provision for contract losses of approximately $75,000 reflected the activities of one biopharmaceutical collaboration research project.
Research and development expenses for the quarter ended June 30, 2020 increased to approximately $1,116,000 compared to $818,000 for the same period a year ago. The increase primarily reflected the costs of additional internal research projects.
There were no research and development expenses – related party, for the quarter ended June 30, 2020 compared to approximately $336,000 for the same period a year ago. The decrease was due to the completion of the Research Service Agreement with BDI in June 2019.
General and administrative expenses for the quarter ended June 30, 2020, decreased 21.2% to approximately $1,475,000 compared to $1,871,000 for the same period a year ago. The decrease principally reflected reductions in noncash share-based compensation expenses of $165,000, executive compensation costs and accrued incentives of $150,000, legal and NASDAQ uplisting expenses of $102,000, business development and investor relations costs, including travel expenses of $24,000, offset by increases in insurance premium and outside service costs of $45,000.
Interest income for the quarter ended June 30, 2020 was approximately $147,000 compared to $266,000 for the same period a year ago. The decrease was primarily due to the lower interest rate and yield on the Company’s investment grade securities, which are classified as held-to-maturity.
Net loss for the quarter ended June 30, 2020 was approximately $2,651,000, or $(0.10) per share, compared to $2,696,000, or $(0.10) per share for the same period a year ago.
FOR THE SIX MONTHS ENDED JUNE 30, 2020
Research and development revenue for the six months ended June 30, 2020, increased to approximately $840,000 compared to $793,000 for the six months ended June 30, 2019. The increase in revenue and cost of research and development revenue for the six months ended June 30, 2020 reflected ten on-going research collaborations compared to seven collaborations for the same period a year ago. The increase in provision for contract losses reflected the activities of one biopharmaceutical collaboration research project.
Research and development expenses for the six months ended June 30, 2020 increased to approximately $1,872,000 compared to $1,511,000 for the same period a year ago. The increase primarily reflected the costs of additional internal research projects.
There were no research and development expenses – related party, for the six months ended June 30, 2020 compared to approximately $726,000 for the same period a year ago. The decrease was due to the completion of the Research Service Agreement with BDI in June 2019.
General and administrative expenses for the six months ended June 30, 2020, decreased 5.2% to approximately $3,129,000 compared to $3,299,000 for the same period a year ago. The decrease principally reflected reductions in executive compensation costs and accrued incentives of $220,000, legal and NASDAQ uplisting expenses of $125,000, noncash share-based compensation expenses of $68,000, offset by increases in insurance premium of $147,000, business development and investor relations costs of $47,000 and other increases of $49,000
Interest income for the six months ended June 30, 2020 was approximately $315,000 compared to $533,000 for the same period a year ago. The decrease was primarily due to the lower interest rate and yield on the Company’s investment grade securities, which are classified as held-to-maturity.
Net loss for the six months ended June 30, 2020 was approximately $4,866,000, or $(0.18) per share, compared to $4,871,000, or $(0.18) per share for the same period a year ago.
CONFERENCE CALL INFORMATION
Dyadic management will host a conference call today, Thursday, August 13, 2020, at 5:00 PM ET to discuss the financial results for the quarter ended June 30, 2020. In order to participate in the conference call, please dial (877) 407-8033 for U.S./Canada callers and +(201) 689-8033 for International callers or use webcast link: https://www.webcaster4.com/Webcast/Page/2031/36260
An archive of the webcast will be available approximately three hours after completion of the live event and will be accessible on the “Investors” section of the Company’s website at http://www.dyadic.com . To access the replay of the webcast, please follow the Webcast link above. A dial-in replay of the call will also be available to those interested. To access the replay, please dial 1 (877) 481-4010 (U.S. or Canada) or 1 (919) 882-2331 (International) and enter replay pass code: 36260.
About Dyadic International, Inc.
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 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. Certain other research activities are ongoing which include the exploration of using C1 to develop and produce certain metabolites and other biologic products. 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.
Please visit Dyadic’s website at http://www.dyadic.com for additional information, including details regarding Dyadic’s plans for its biopharmaceutical business.
Safe Harbor Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including those regarding Dyadic International’s expectations, intentions, strategies and beliefs pertaining to future events or future financial performance. Actual events or results may differ materially from those in the forward-looking statements as a result of various important factors, including those described in the Company’s most recent filings with the SEC. Dyadic assumes no obligation to update publicly any such forward-looking statements, whether as a result of new information, future events or otherwise. For a more complete description of the risks that could cause our actual results to differ from our current expectations, please see the section entitled “Risk Factors” in Dyadic’s annual reports on Form 10-K and quarterly reports on Form 10-Q filed with the SEC, as such factors may be updated from time to time in Dyadic’s periodic filings with the SEC, which are accessible on the SEC’s website and at http://www.dyadic.com/.
Contact:
Dyadic International, Inc.
Ping W. Rawson
Chief Financial Officer
Phone: (561) 743-8333
Email: mailto:prawson@dyadic.com
Thursday, August 13, 2020
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.
Eyes are on the INSPIRE trial. Onconova’s main focus remains as the pivotal INSPIRE study, assessing rigosertib in the 2nd-line high-risk myelodysplastic syndrome (HR-MDS) patients. The company recently reached the required number of survival events to initiate data analysis for the INSPIRE trial. The company anticipates providing preliminary top-line data in Q3 2020 and full top-line data at a medical conference in Q4 2020.
Q2 earnings results. Net operating loss was $7.4 million for the quarter including $4.8 million research and development (R&D) expenses $2.6 million general and administrative (SG&A) expenses. Onconova reported ($0.04) EPS. We are maintaining our F2020 estimates of …
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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.
Monday, August 10, 2020
As of April 24, 2020, Noble Capital Markets research on Neovasc is published under ticker symbols (NVCN and NVCN:CA). The price target is in USD and based on ticker symbol NVCN. Research reports dated prior to April 24, 2020 may not follow these guidelines and could account for a variance in the price target.
Neovasc Inc is a specialty medical device company. The company develops, manufactures and markets products for the rapidly growing cardiovascular marketplace. Its products include the Tiara for the transcatheter treatment of mitral valve disease and the Neovasc Reducer for the treatment of refractory angina. Neovasc is developing the Tiara for the treatment of mitral valve disease. Neovasc operates its business in one segment.
Ahu Demir, Ph.D., Biotechnology Research Analyst, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Reducer EU revenues declined due to COVID-19. Neovasc reported Q2 2020 ending on June 30, 2020. The company’s lead product Reducer is marketed in the EU and achieved $284,000 in revenues. The sharp decline (-46%) was attributed to the pandemic, as Reducer implant procedures are considered elective, which were nearly ceased in March 2020 due to the COVID-19 situation. The Reducer implants picked up in June. We expect the backlog of delayed implantation to recover in the second half of 2020, assuming pandemic to remain stable.
Q2 earnings results. Total expenses were $8.9 million including 4.3 million-selling, general and administrative expenses, $4.6 million clinical trials, and product development expenses in Q2 2020. The company reported …
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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.
Friday, August 7, 2020
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.
Q2 2020 financial results. The company reported $19.4 million cash balance as of June 30, 2020. Net operating loss was $4.0 million for the quarter with $2.0 million research and development expenses and $2.0 million general and administrative expenses. Cocrystal reported ($0.07) EPS.
Maintaining our F2020 estimates. We think the reported numbers are in line with our F2020 estimates. We are forecasting $5.6 of R&D expenses and $5.0 million of SG&A expenses. Our F2020 estimates are …
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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.
– COVID-19 program in preclinical development; Discussions with potential strategic partners ongoing –
– Merck collaboration to discover and develop influenza A/B antiviral agents progresses –
BOTHELL, WA, August 6, 2020 – Cocrystal Pharma, Inc. (NASDAQ: COCP), (“Cocrystal” or the “Company”), a clinical stage biotechnology company discovering and developing novel antiviral therapeutics, today announced its financial results for the quarter ended June 30, 2020 and provided program updates.
Recent Highlights
“We have continued to move our antiviral programs forward. We are encouraged by our preclinical studies of COVID-19 inhibitors,” commented Dr. Gary Wilcox, Chairman and Chief Executive Officer of Cocrystal. “With a foundation of strong fundamentals, we believe Cocrystal is poised to build shareholder value.”
Development Programs Overview
COVID-19 Coronavirus Program:
Aggressively pursuing the development of novel antiviral compounds for the treatment of coronavirus infections using our established proprietary drug discovery platform.
The compounds licensed from KSURF have demonstrated in vitro anti-SARS-CoV-2 activity responsible for the COVID-19 pandemic, and in vivo efficacy in MERS-CoV-infected animal models. Cocrystal initiated its preclinical studies of COVID-19 inhibitors during the second quarter and is currently developing additional COVID-19 inhibitors utilizing its proprietary platform technology. The Company is in discussions with potential strategic partners.
Influenza A/B Inhibitors: Merck Collaboration
Exclusive license and collaboration agreement with Merck to discover and develop proprietary influenza A/B antiviral agents.
Cocrystal’s exclusive license and collaboration agreement with Merck Sharp & Dohme Corp. (“Merck”) to discover and develop proprietary influenza A/B antiviral agents is ongoing. Merck has funded the collaborative influenza A/B program and could potentially provide up to $156 million in milestone payments as the collaboration proceeds through clinical and commercial development, plus royalties following commercialization.
CC-42344: Influenza A Program:
Novel, broad spectrum influenza antivirals that are specifically designed to be effective against pandemic and seasonal influenza A strains of the influenza virus and to have a high barrier to resistance due to its novel mechanism of action.
The Company’s lead molecule in development, CC-42344, is currently being evaluated in IND-enabling studies for the treatment of influenza. CC-42344 has shown excellent antiviral activity against influenza A strains, including avian pandemic strains and Tamiflu® resistant strains, and shows a favorable pharmacokinetic and safety profile.
CC-31244: Hepatitis C Program:
Potential best-in-class pan-genotypic inhibitor of NS5B polymerase for the ultra-short combination treatment of hepatitis C infection.
The final study report of Cocrystal’s U.S. Phase 2a clinical trial evaluating CC-31244 combination therapy for the ultrashort treatment of hepatitis C virus (“HCV”) infected individuals has been completed and confirms the previously released data that it is effective and well tolerated. Partnering efforts continue for the Company’s fully owned ultrashort treatment of HCV.
Norovirus Program:
Developing inhibitors targeting Norovirus RNA-dependent RNA polymerase and protease.
Cocrystal continues to identify and develop non-nucleoside polymerase inhibitors using its proprietary structure-based drug design technology platform. Cocrystal recently entered into license agreements with KSURF to further develop proprietary broad-spectrum protease inhibitors to treat Norovirus and Coronavirus infections.
Summary of Financial Results for Q2 2020
As of June 30, 2020, Cocrystal had approximately $19,365,000 cash on hand.
Revenue recorded for the three and six months ended June 30, 2020 was $554,000 and $1,015,000, respectively, compared with $592,000 and $5,670,000 for the three and six months ended June 30, 2019, respectively. The revenue for the six months ended June 30, 2019 included $4,368,000 as consideration in exchange for conveyance of intellectual property rights at the signing of the Merck Collaboration Agreement executed on January 2, 2019.
General and administrative expenses for the three and six months ended June 30, 2020 was $2,028,000 and $3,167,000, respectively, compared with $1,051,000 and $2,374,000 for the three and six months ended June 30, 2019, respectively. The increase for the three and six months ended June 30, 2020 compared to the three months ended June 30, 2019 was primarily due to litigation costs, insurance increases and executive compensation.
Total research and development expenses for the three and six months ended June 30, 2020 was $1,976,000 and $3,259,000, respectively, compared with $1,091,000 and $1,969,000 for the three and six months ended June 30, 2019, respectively. The increase for the three and six months ended June 30, 2020 compared to the three months ended June 30, 2019 was primarily due to increases in COVID-19 and Influenza programs.
Net loss for the three and six months ended June 30, 2020 was $3,495,000 and $5,485,000, respectively, compared with a net loss of $1,515,000 and a net income of $1,456,000 for the three and six months ended June 30, 2019, respectively, as a result of revenue and expenses described above.
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
COCP@jtcir.com
Wednesday, August 5, 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.
Wednesday, August 5, 2020
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.
EDMONTON, ALBERTA – August 4, 2020 – 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 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: czo@jtcir.com
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
– 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
COCP@jtcir.com
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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