RE:RE:RE:CONFLICT OF INTEREST"Questions remain then: (1) How many hours per week does Gilles Gagnon devote to Prodev Pharma? (2) How many hours per week does Gilles Gagnon devote to Ceapro?" "Management services for the Corporation are not, to any material degree, performed by persons other than the directors or executive officers of the Corporation" pg. 20 Information Circular
"The CEO or President, as the case may be, has traditionally negotiated directly with the CGCNC on an annual basis with respect to the annual salary of the CEO or President, as the case may be. Each Named Executive Officer’s salary is reviewed on an annual basis by the CGCNC, and if deemed appropriate, any changes in salary for the upcoming year are negotiated as set out above then approved and ratified by the CGCNC, if necessary." pg. 12 Information Circular
CZO is a $18.8 million revenue company with its own plant and significant multi-asset pipeline. There is a lot to manage. Prodev is likely used for tax purposes, in my opinion. April year-end financials news release and highlights:
2022 Corporate and Operational Highlights
Pipeline Development
Avenanthramides:
Clinical Trial
- Protocol for Phase 1 safety and tolerability study with healthy volunteers completed with Montreal Heart Institute (MHI) and submitted to Health Canada which was subsequently accepted for expansion into a Phase 2a study including patients with mild inflammation.
- Received approval in December 2022 from Health Canada to commence a Phase 1-2a double-blind, placebo-controlled, randomized, adaptive, first-in-human clinical study to assess safety, tolerability, and pharmacokinetics of single and multiple ascending oral doses of avenanthramide. Up to 96 subjects may be included in the study and dosages will escalate from 30mg to 960mg according to response. Initial approval received from MHI’s Ethics Committee to initiate patient recruitment. Phase 1 part of the study is expected to be completed by year end.
Formulation
- Production and preparation of the selected 30mg and 240mg pill formulation of the drug product for a Phase 1 study was scaled-up in preparation of the clinical batches that were manufactured, packaged and labeled in June 2022 by Corealis Inc. GMP Manufacturing Services (“Corealis”). Stabilities studies remain ongoing.
- In planning for an extension into a Phase 2a (subject to Phase 1 outcomes), Ceapro’s R&D group manufactured sufficient additional GMP batches of avenanthramides active ingredient powder for a second formulation of avenanthramides pills. The second GMP clinical batches will also be manufactured, packaged and labeled by Corealis in 2023.
(Avenanthramides) Malted Technology
- Patent No. 408344 entitled, “Method for Increasing Concentration of Avenanthramides in Oats,” issued by The Indian Government Patent Office.
Alginate:
- Developed and fine-tuned new PGX-dried chemical complexes mostly using sodium alginate as a carrier. Emphasis put on thin strips of alginate/yeast beta glucan as a potential nutraceutical product with immune boosting properties.
- Published results for PGX-processed alginates in the Journal of CO2 Utilization.
- Published positive results for PGX-processed alginates impregnated with CoQ10 in The Journal of Supercritical Fluids. This publication confirms alginate as a carrier for other bioactives.
- Announced highly positive results for bioavailability studies using alginate and yeast beta glucan (YBG) as carriers for coenzyme Q10 (CoQ10). More specifically, results showed a statistically significant difference (p<0.02) between the amount of CoQ10 absorbed from impregnated YBG compared to commercial standard formulations: two times higher absorption than Cyclodextrin/CoQ10 and four times higher absorption than triolein/CoQ10.
Yeast Beta Glucan (YBG)
- Analyzed and screened YBG feedstock from numerous global suppliers to select ideal sources for best possible product.
- Identified process conditions for YBG improving morphology of YBG-processed using PGX Technology (PGX-YBG) to boost immunomodulating activity. Progress achieved for the pre-processing of YBG to ensure homogeneous dispersion and deagglomeration of polymers and batch-to-batch consistency.
- Obtained further evidence confirming that PGX-YBG is suitable for lung inhalation.
- Demonstrated in vitro that PGX processed YBG can prevent the activation of macrophages toward a pro-fibrotic phenotype which, according to experts in the field, is seen as a viable therapeutic strategy toward fibrotic disease.
- PGX-YBG binds to specific receptors (Dectin 1) located on macrophages responsible for the cascade of immunomodulating events when activated.
- McMaster’s research team discovered a new mechanism of action as per PGX-YBG’s ability to reprogram macrophages on its own.
- Following this discovery, announced expansion of collaborative research program with McMaster University to develop an inhalable immuno-therapeutic/-prophylactic for COVID-19-induced lung fibrosis. Dr. Martin Kolb was confirmed as co-lead of this project along with Dr. Kjetil Ask and Dr. Todd Hoare. This project is supported by Mitacs.
- Animal studies are ongoing. Go/No-Go decision for a Phase 1 trial is expected to be made during summer 2023.
Technology:
- Pursued technical upgrades of Ceapro’s PGX demo plant in Edmonton focused on the commercial scale up of an impregnation unit to produce chemical complexes with alginate/YBG. Stability studies initiated for these new chemical entities.
- Pursued engineering design for PGX processing commercial scale unit. A decision was made to use a stepwise approach to ensure standardization of product specifications at each scale level from current 10 Liters to 50-100 Liters vessels. Alginate and YBG would be the first products to be processed at large scale level. Given regulatory requirements and to accelerate market entry, YBG as a standalone and/or in combination with alginate will be developed at first as a nutraceutical/ immune booster.
- Announced the signing of an agreement with the University of Alberta to implement this mid-scale level PGX unit at Agri-Food-Discovery Place. Alginate and YBG will be the first bioactives to be processed at this facility. This work will be conducted with two specialized engineering firms, one from Europe with expertise in pharmaceutical plants and high-pressure equipment and a local engineering firm from Alberta who will facilitate installation and work with local regulatory agencies to comply with Canadian regulations and codes. Site and installation of PGX pilot unit expected to be completed by mid-2024.
- Continued projects with University of Alberta and McMaster University for the development of potential delivery systems for multiple applications in healthcare.
Bioprocessing Operations
- Ceapro’s dedicated production team successfully responded to the growing market demand for the cosmeceutical base business by producing over 300 metric tons of active ingredients in 2022.
- Successfully passed audits conducted by three major customers at the Edmonton facility.
- Received renewal of the Site License from the Health Canada Natural Product Directorate for a period of two years. This License enables the Company to manufacture, package, label, release and distribute final products.
Corporate
- Signed a Supply and Distribution Agreement with Symrise securing the long-term sustainability of Ceapro’s base business.
- Appointed Mr. Ronnie Miller, former long-serving President & CEO of Roche Canada, to the Company’s Board of Directors.
- Appointed Mrs. Genevieve Foster, an accomplished lawyer, Corporate Director of Governance and businesswoman, to the Company’s Board of Directors.
- Appointed Ms. Sigrun Watson, a recognized commercial leader with over 20 years of experience, as Chief Revenue Officer.
- Conducted a strategic plan exercise based on three overarching Strategic Imperatives to create value for shareholders: (1) Diversify, secure and accelerate growth; (2) Prepare for commercialization of priority pipeline assets; and (3) Align company structure, culture, and processes to support accelerated growth and entry into new markets.
Subsequent to Year End
- Announced that data from the research collaboration with the Angiogenesis Foundation will be presented at the 2023 Annual Meeting of the Wound Healing American Society to be held April 26-29, 2023.
- Announced that data from the research collaboration with McMaster University will be presented at the 2023 American Thoracic Society (ATS) International Conference to be held May 19-24, 2023.