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Predictive Oncology Strengthens Offerings with GMP Lab and Addition of Leading Expert in Formulation Development

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Predictive Oncology (NASDAQ: POAI) has announced significant advancements to enhance its services for pharmaceutical and biotech clients. The opening of a Good Manufacturing Practices (GMP) lab will facilitate the transition from pre-clinical drug development to IND qualification, enabling faster entry to phase 1 clinical trials. Additionally, Dr. Kamal Egodage joins as a strategic advisor to lead formulation development and sales strategies, contributing to the launch of innovative products, including a new static light scattering instrument and a high-capacity endotoxin removal column.

Positive
  • Launch of Good Manufacturing Practices (GMP) lab to aid clients in transitioning to IND qualification.
  • Appointment of Dr. Kamal Egodage as strategic advisor enhances formulation development efforts.
  • Introduction of the Free Flow static light scattering system increases throughput capabilities.
  • New EndoBind-R II endotoxin column provides improved endotoxin removal from samples.
Negative
  • None.

EAGAN, Minn., Sept. 19, 2022 (GLOBE NEWSWIRE) -- Predictive Oncology (NASDAQ: POAI) today announced several key developments to further strengthen the company’s offerings for pharmaceutical and biotech customers.

First is Predictive Oncology’s Good Manufacturing Practices (GMP) lab, which opens the opportunity to help clients move from pre-clinical drug development to the investigational new drug (IND) qualification, including phase 1 clinical trials. The company has begun accepting orders.

“Adding GMP production capabilities at Predictive Oncology is a major accomplishment that has been underway for the past year and a half. This highly regulated designation, required by the FDA in the manufacturing of pharmaceuticals, will generate opportunities for added business growth for us and provide a valuable resource to our customers. Keeping the development and production of our proprietary endotoxin removal process in-house saves our customers time and money, which is especially important at a time when drug development companies face increased pressure to get to clinical trials faster,” noted J. Melville Engle, CEO of Predictive Oncology.

Second, Predictive Oncology is pleased to announce the addition of a strategic advisor with two decades of experience in drug development. As a consultant to the company, Dr. Kamal Egodage, President of Canopy Biopharma, will lead formulation development and sales growth strategies for Predictive Oncology’s drug formulation area of business. Dr. Egodage will oversee the development and sales of formulations that solubilize and stabilize biological therapeutics, including vaccines that encompass proteins, peptides, virus-like particles and whole live attenuated viruses.

A proven leader in the biopharmaceutical industry, Dr. Egodage brings over 25 years of experience in pharmaceutical, biotechnology and biotech start-up environments in the US, Europe and Asia. He has supported over 75 pharmaceutical products through analytical and formulation development, clinical trials, commercialization and post-marketing lifecycle management.

“Dr. Egodage brings an in-depth knowledge of the biopharmaceutical regulatory and development process that makes him an ideal fit for the growth plans we have at Predictive Oncology. He has the vision, passion and understanding to help expand our business growth in the area of formulation solutions,” explained Larry DeLucas, PhD., Senior Vice President of Operations at Predictive Oncology.

Dr. Egodage’s engagement comes at a time of growth for Predictive Oncology with the GMP lab and launch of two new products.

  • Today, Predictive Oncology announces the next generation of a classical static light scattering (SLS) instrument that will be the first of its kind. The Free Flow SLS instrument is a rapid automated static light scattering system that will expand the company’s offerings with additional throughput capabilities in developing formulations for customers with proteins, peptides, vaccines and whole attenuated virus vaccines.

  • The company also is introducing a new high-capacity endotoxin column, called EndoBind-R II, which more effectively removes endotoxins from aqueous samples. This is a non-epoxy media with a high concentration of peptide bound that can be operated under HPLC (high-pressure) conditions to reduce endotoxin levels below required FDA levels.

Inquiries for the new products or GMP lab capabilities can be made by emailing Larry DeLucas at LDelucas@solublebiotech.com.

About Predictive Oncology
Predictive Oncology (NASDAQ: POAI) is a knowledge-driven company focused on applying artificial intelligence (AI) to develop optimal cancer therapies, which can lead to more effective treatments and improved patient outcomes. Through AI, Predictive Oncology uses a biobank of 150,000+ cancer tumors, categorized by patient type, against drug compounds to help the drug discovery process and increase the probability of success. The company offers a suite of solutions for oncology drug development from early discovery to clinical trials.

About Canopy Biopharma
Canopy Biopharma LLC is a technical and business consultancy that supports biotherapeutics development, regulatory strategies, and health authority submissions from discovery to commercialization. Canopy Biopharma enables a diverse small to medium sized biotech companies worldwide to accelerate the development of therapeutics.

Public Relations Contact:
Predictive Oncology
Theresa Ferguson
630-566-2003
tferguson@predictive-oncology.com 

Investor Relations Contact:
Landon Capital
Keith Pinder
(404) 995-6671
kpinder@landoncapital.net 

Forward-Looking Statements:
Certain matters discussed in this release contain forward-looking statements. These forward-looking statements reflect our current expectations and projections about future events and are subject to substantial risks, uncertainties and assumptions about our operations and the investments we make. All statements, other than statements of historical facts, included in this press release regarding our strategy, future operations, future financial position, future revenue and financial performance, projected costs, prospects for new and existing products and in general, changes in management, plans and objectives of management are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “would,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Our actual future performance may materially differ from that contemplated by the forward-looking statements as a result of a variety of factors including, among other things, factors discussed under the heading “Risk Factors” in our filings with the SEC. Except as expressly required by law, the Company disclaims any intent or obligation to update these forward-looking statements.


FAQ

What are the key developments announced by Predictive Oncology on Sept 19, 2022?

Predictive Oncology announced the opening of a GMP lab to assist in drug development and the appointment of Dr. Kamal Egodage as a strategic advisor.

How will the GMP lab benefit Predictive Oncology's customers?

The GMP lab will help clients transition from pre-clinical drug development to IND qualification, accelerating their path to phase 1 clinical trials.

What new products did Predictive Oncology introduce?

Predictive Oncology launched the Free Flow static light scattering instrument and the EndoBind-R II endotoxin removal column.

Who is Dr. Kamal Egodage and what role will he play at Predictive Oncology?

Dr. Kamal Egodage is a strategic advisor with extensive experience in drug development, overseeing formulation development and sales growth strategies.

What is the significance of the Free Flow SLS instrument for Predictive Oncology?

The Free Flow SLS instrument is the first of its kind, enhancing the company's capabilities in developing formulations for various biological therapeutics.

Predictive Oncology Inc.

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