Oncology Pharma, Inc. Has Received the Committed Funding to Perform All Necessary IND-Enabling Preclinical Work for Its First Lead Candidate, a Dactinomycin Nanoemulsion Drug Product
Oncology Pharma, Inc. (OTC PINK:ONPH) has successfully obtained and segregated funds necessary for the initial phase of developing a nanoemulsion of dactinomycin. An expert team in drug development is managing this phase, focusing on reducing costs and time for commercializing a new drug formulation. The next step will include assessing the nanoemulsion's safety in nonclinical studies before submitting an Investigational New Drug application to the FDA for human trials.
- Secured funding for the first phase of dactinomycin nanoemulsion development.
- Experienced team selected for drug development, enhancing confidence in the project.
- Focus on reducing costs and commercialization time for new drug formulations.
- Current negative operating cash flows signal potential financial instability.
- Need for additional funding may lead to highly dilutive terms for shareholders.
- Risks include the company's reliance on regulatory approvals and market acceptance.
SAN FRANCISCO, CA / ACCESSWIRE / September 13, 2021 / Oncology Pharma, Inc. (OTC PINK:ONPH). In keeping with management's commitment to continue implementation of Oncology Pharma's ("the Company") capital formation plan, the Company has obtained, received and segregated all funds necessary to execute the first phase of the development project of a nanoemulsion of dactinomycin, with the initial tranche released as scheduled.
Management of Oncology Pharma felt it was important to select an experienced team for this process. We are confident in the team that is conducting this initial phase, as they have vast experience in drug development. The team is made up of individuals that have a specialty in biotech, pre-clinical development and regulatory approval of numerous novel medical devices and pharmaceutical products. They are experts in implementing highly effective corporate culture and quality management infrastructure compliant with US FDA and ISO regulations. The team has further developed and implemented ISO (International Organization for Standardization), GMP (Good Manufacturing Practices) and GLP (Good Laboratory Practices) quality systems. Managed regulatory applications for various medical product manufacturers (510(K), PMA IND/IDE, etc.).
The primary goal is to bring new pharmaceutical drug formulations to market with a focused approach that aims to reduce overall costs and time to commercialization. The first step will be to formulate an existing FDA-approved active pharmaceutical ingredient (dactinomycin) inside a nanoemulsion formulation. The next step will involve assessing the lead drug formulation in nonclinical pharmacokinetic and toxicokinetic safety studies. This is to determine if the nanoemulsion formulation is safer than the free drug alone. With data accumulated demonstrating a safer drug, the Investigational New Drug application will be submitted to the US FDA, seeking permission to move into human clinical trials.
ABOUT ONCOLOGY PHARMA, INC.
ONCOLOGY PHARMA, INC. (OTC PINK:ONPH) (the 'Company') is currently engaging in research and development of therapeutics for oncology and prides itself for having a world-class Advisory Board that keeps the Company in the forefront of developing technologies in cancer research, biotechnology, and healthcare.
FORWARD LOOKING STATEMENTS
Certain of the matters discussed in this announcement contain forward-looking statements that involve material risks to and uncertainties in the Company's business that may cause actual results to differ materially from those anticipated by the statements made herein. Such risks and uncertainties include risks related to licensing arrangements and joint ventures, including the need to negotiate the definitive agreements for the relationships; possible failure to realize anticipated benefits of business relationships, and costs of providing funding to these business relationships. Other risks and uncertainties relating to the Company include, among other things, current negative operating cash flows and a need for additional funding to finance our operating plan; the terms of any further financing, which may be highly dilutive and may include onerous terms; unexpected costs and operating deficits, and lower than expected sales and revenues; uncertain willingness and ability of customers to adopt new technologies and other factors that may affect further market acceptance; adverse economic conditions; adverse results of any legal proceedings; the volatility of our operating results and financial condition; inability to attract or retain qualified senior management personnel, including sales and marketing personnel; our ability to establish and maintain the proprietary nature of our technology through the patent process, as well as our ability to possibly license from others patents and patent applications necessary to develop products; the Company's ability to implement its long range business plan for various applications of its technology; the Company's ability to enter into agreements with any necessary marketing and/or distribution partners and with any strategic or joint venture partners; the impact of competition; the obtaining and maintenance of any necessary regulatory clearances applicable to applications of the Company's technology; management of growth; and, other risks and uncertainties. This is not a solicitation to buy or sell securities and does not purport to be an analysis of the Company's financial position.
CONTACTS:
For additional Information, please contact the Oncology Pharma at:
One Sansome Street, Suite 3500
San Francisco, CA 94104
Phone: 415-869-1038
Fax: 415-946-8801
Website: www.oncology-pharma.com
Email: info@oncology-pharma.com
SOURCE: Oncology Pharma Inc.
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