AUSTIN, Texas, U.S.A., TORONTO, Canada and RIONEGRO, Colombia (January 3, 2024)
Benuvia Operations, LLC (“Benuvia”), a FDA registered, DEA licensed and cGMP certified leader in pharmaceutical cannabinoids, and PharmaCielo Ltd. (“PharmaCielo”) (TSXV: PCLO, OTCQX: PCLOF), the Canadian parent of Colombia’s premier cultivator, producer and global supplier of dried flower and medicinal-grade cannabis extracts, PharmaCielo Colombia Holdings S.A.S. (“Holdings”), are thrilled to announce a strategic partnership to produce cGMP pharmaceutical-grade Active Pharmaceutical Ingredients (“APIs”) for the global market, including Brazil, Australia, Europe and U.S.A. (the “Strategic Partnership”).
As part of the Strategic Partnership, PharmaCielo will be responsible for the cultivation of cannabis and hemp under Good Agricultural and Collection Practice (“GACP”) conditions in Colombia, and Benuvia will leverage its FDA registered, and DEA licensed (schedules I-V) cGMP development manufacturing facility in Austin, Texas, to produce final products [in its facilities in locations]. To both companies’ knowledge, this is an industry-first partnership to provide Seed-to-Pharma products globally where cGMP and its European equivalent EU-GMP certification are must haves. This model will emphasize quality and compliance as well as sustainable and ethical sourcing and represents a significant improvement vs. the industry’s current primary operating model Phyto to Pharma products, where [EXPLAIN].
The partnership extends beyond mere manufacturing; it encompasses a shared vision to explore and offer the market innovative finished dose form services. This initiative will focus on producing cGMP and EU-GMP compliant pharmaceutical products, a step forward in meeting the growing global demand for high-quality, reliable medicinal cannabis products, produced under strict standards.
Management Commentary
“Our collaboration with PharmaCielo represents a significant milestone in our commitment to excellence in pharmaceutical development,” said Darwin Richardson, CEO of Benuvia. “This partnership aligns perfectly with our mission to deliver superior quality products while adhering to the highest manufacturing standards and allows Benuvia to provide our customers with more sourcing options beyond synthetic APIs. With these additional capabilities, Benuvia and Pharmacielo customers can develop drug product formulations for their APIs for both clinical and commercial purposes.”
Marc Lustig, Chairman and CEO of PharmaCielo, added, “PharmaCielo has the genetics library, expertise and production capacity to design and deliver tailored, pharma-quality cultivars for the creation of APIs, at scale. We expect this partnership with Benuvia to enable us to access additional customer opportunities as well as expanding our product shelf with additional cGMP final products.”
This partnership is poised to set new standards in the pharmaceutical industry, offering promising advancements in the medicinal cannabis sector. Both Benuvia and PharmaCielo are dedicated to harnessing the potential of cannabinoids for therapeutic purposes, ensuring that products are not only effective but also manufactured responsibly and sustainably, to cGMP and EU-GMP standards.
Interest Shares
Today, PharmaCielo also announced that it intends to issue, subject to the approval of the TSX Venture Exchange, 4,179,670 common shares of PharmaCielo (“Interest Shares”), at an effective price of $0.1925 per Interest Share, in satisfaction of an aggregate of $804,590 in semi-annual interest payments due to holders of 11% secured debentures of the Company due December 24, 2024, and June 30, 2026 (the “Debentures”). The effective price of the Interest Shares was determined by dividing the cash interest otherwise payable by the number of shares issuable under each Debenture, as determined on December 1, 2023, in accordance with the terms of the Debentures.
The Interest Shares are subject to the balance, if any, of the 4-month statutory hold period applicable to the relevant Debenture under Canadian securities laws.
Grant of Stock Options, Restricted and Deferred Share Units
Effective January 2, 2024, PharmaCielo granted an aggregate of 3,200,000 stock options, 250,000 Deferred Share Units (“DSUS”), and an aggregate of 1,000,000 Restricted Share Units (“RSUs”) to directors, officers, and key employees. The options and RSUs vest 1/3 immediately, 1/3 on the first-year anniversary and 1/3 on the second-year anniversary. The options are exercisable at a price higher of $0.18 per share or the closing share price on January 5, 2024, and expire five years from the date of grant. The RSUs, DSUs and options are granted pursuant to the Company’s RSU, DSU and stock option plans, respectively.
For further information:
Brandon Kidd, Chief Business Development Officer
bk***@be*****.com
Ian Atacan, Director & Chief Financial Officer
+1 416-562-3220
i.******@ph*********.com
Media and Investor Inquires:
in*******@ph*********.com
About Benuvia
Benuvia Operations, LLC: is a privately held, FDA registered, and DEA licensed (schedules I-V) cGMP development and manufacturing company covering everything from API production, drug production formulation, packaging and stability tests to distribution. With a focus on innovation and compliance, Benuvia is committed to enhancing patient care and advancing pharmaceutical technology.
About PharmaCielo
PharmaCielo Ltd. (TSXV: PCLO, OTCQX: PCLOF) is a global company, headquartered in Canada, with a focus on ethical and sustainable processing and supplying of all natural, pharmaceutical-grade medical cannabis products to large channel distributors. PharmaCielo’s principal (and wholly owned) subsidiary is PharmaCielo Colombia Holdings S.A.S., headquartered at its cultivation and processing center located in Rionegro, Colombia.
The board of directors and executive team of PharmaCielo are comprised of a diversely talented group of international business executives and specialists with relevant and varied expertise. PharmaCielo recognized the significant role that Colombia’s ideal location plays in building a sustainable business in the medical cannabis industry, and the Company, together with its directors and executives, is executing on a business plan focused on supplying the international marketplace.
Forward-Looking Statements
This news release contains forward-looking statements regarding Benuvia and PharmaCielo. Forward-looking statements can be identified by the use of words such as “expects”, “is expected”, “intends”, “anticipates”, “believes”, or variations of such words and phrases or state that certain actions, events or results “may” or “will” be taken, occur or be completed or achieved.
Forward-looking statements can be affected by known and unknown risks, uncertainties and other factors, including changes to PharmaCielo’s development plans, the failure to obtain and maintain all necessary regulatory approvals relating to the export of cannabinoid products and the import of these products into other countries, TSX Venture Exchange approval, the inability to export or distribute commercial products through sales channels as anticipated due to economic or operational circumstances, risks associated with operating in Colombia, fluctuation of the market price for the Company’s products, risks associated with global economic instability relating to COVID-19 or other developments, risks related to retention of key Company personnel, currency exchange risk, competition in PharmaCielo’s market and other risks discussed or referred to under the heading “Risk Factors” in PharmaCielo’s Annual Information Form for the financial year ended December 31, 2019, which is available at www.sedar.com. Accordingly, readers should not place undue reliance on forward-looking statements. Except as required by law, PharmaCielo undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.
Neither the 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 press release.
