Predictive Oncology’s TumorGenesis Division Secures First Commercial Sale of its Novel Ovarian Cancer Cell Media

Rhea-AI Summary

Predictive Oncology (NASDAQ: POAI) has made significant strides by fulfilling its first commercial order for specialized ovarian cancer cell culture media. This media, developed by its TumorGenesis division, allows researchers to grow patient-derived ovarian cancer cells more effectively, preserving crucial DNA, RNA, and proteomic signatures. The order was placed by a leading medical institution in New England. This innovative product aims to address the challenges posed by unvalidated media that increases research costs and reproducibility issues, ultimately driving advancements in cancer treatment research.

Positive

• First commercial order secured for unique ovarian cancer cell culture media.
• Media retains over 95% of DNA and RNA signatures, enhancing research accuracy.
• Addresses significant challenges in ovarian cancer research, potentially reducing costs.

Negative

• Continued dependence on external financing raised in the forward-looking statements.
• Current negative operating cash flows reported, posing financial sustainability concerns.

A Top US Medical Institution Places the First Commercial Order for the Media used to grow Ovarian Cancer Cell Types that are Exceedingly Difficult to Grow and Retain the Signatures of the Patient Derived Sample.

MINNEAPOLIS, June 18, 2020 (GLOBE NEWSWIRE) -- Predictive Oncology Inc. (NASDAQ: POAI) (“Predictive” or “the Company”) a knowledge-driven company focused on applying artificial intelligence to personalized medicine and drug discovery, today announces that Predictive’s TumorGenesis division sold its first order of its unique ovarian cancer cell culture media for cancer cells collected from patient derived samples (PDx) through its distributor US Biological Corporation. The media used to grow the novel and unique ovarian cancer cell lines, licensed by TumorGenesis and its partner, GLG Pharma are able to retain 95%+ of the DNA and RNA as well as crucial proteomic signatures. The media was sold to a top rated medical university in the New England area for research in isolating and growing ovarian cancer cells from the fluid often found in the abdomen of women with advanced ovarian cancer, called the ‘ascites’ fluid. Ovarian cancer cell culturing from ascites fluids are notoriously difficult using standard media mixes often prone to failure and cell lines that are not representative of the patient’s ovarian cancer.

A recent publication highlighted the waste in research using unvalidated media and reagents that showed an increase from $28 billion in 2015¹ to 2020 experiments are the foundation of preclinical research and development, however, irreproducibility rates in preclinical experiments exceed 50%, costing the industry nearly $48 billion annually².

“Capturing and culturing and then being able to study ovarian cancer cell types has always been limited by the ability to grow reproducible cultures that reflect what is in the patient”, said Richard Gabriel of TumorGenesis. “We now have isolated and grown 25 ovarian cancer cell types, 11 of that library, represents nearly 95% of all ovarian cancers, many of which have never been cultured prior to this time. This new media will allow researchers around the world to isolate and then culture ovarian cancer cell types and culture them reproducibly to find new targets for treatment, diagnostics or other studies on the close interrelationship of ovarian cancer tumor populations and how they are able to fool a patient’s immune system”, Mr. Gabriel highlighted.

Researchers around the world can now contact US Biological Corporation or Richard Gabriel at TumorGenesis for information on the new media(s) available - rgabriel@tumorgenesis.net.

About Predictive Oncology Inc.

Predictive Oncology (NASDAQ: POAI) operates through three segments (Domestic, International and other), which contain four subsidiaries; Helomics, TumorGenesis, Skyline Medical and Skyline Europe. Helomics applies artificial intelligence to its rich data gathered from patient tumors to both personalize cancer therapies for patients and drive the development of new targeted therapies in collaborations with pharmaceutical companies. Helomics’ CLIA-certified lab provides clinical testing that assists oncologists in individualizing patient treatment decisions, by providing an evidence-based roadmap for therapy. In addition to its proprietary precision oncology platform, Helomics offers boutique CRO services that leverage its TruTumor™, patient-derived tumor models coupled to a wide range of multi-omics assays (genomics, proteomics and biochemical), and an AI-powered proprietary bioinformatics platform to provide a tailored solution to its clients’ specific needs. Predictive Oncology’s Skyline Medical division markets its patented and FDA cleared STREAMWAY System, which automates the collection, measurement and disposal of waste fluid, including blood, irrigation fluid and others, within a medical facility, through both domestic and international divisions. The company has achieved sales in five of the seven continents through both direct sales and distributor partners. For more information, please visit www.Predictive-Oncology.com.

TumorGenesis, Inc. a wholly owned subsidiary specializes in media’s that help cancer cells grow and retain their DNA/RNA and proteomic signatures providing researchers with a tool to expand and study cancer cell types found in tumors of the blood and organ systems of all mammals, including humans. In addition, TumorGenesis is developing a ‘biomarker discovery’ kit and service for life science, pharmaceutical and biotech companies, and research institutions. Its products are sold on-line as well as through a global distributor; US Biologicals Corporation: http://www.usbio.net.

Soluble Biotech Inc., a division of Predictive Oncology Inc. has a technology that allows the company to screen proteins for both solubility and stability. The proteins that have been successfully improved by Soluble include vaccines, antibodies and other proteins used in disease treatment. The company can screen 12,000 possible combinations of formulations of any protein using an exceedingly small amount, 25 milligrams and uses a neural network (AI) and other programs to predict the best formulation combination. It confirms the formulations by making a soluble and stable protein solution. The team at Soluble has worked on other viruses and deadly bacteria to come up with formulations of target proteins that can be used to treat, diagnose, or identify specific protein targets for later drug design. Soluble is expanding its reach by offering its services to COVID-19 antibody and vaccine developers. By having a soluble and stable antibody or vaccine candidate at the highest concentration is not only important for final delivery but is also a critical component in pre-clinical testing in animal models as well as in in vitro assays. Over the last 7 years, Soluble has worked for many large pharmaceutical and biotech companies but has also helped smaller companies that mostly outsource their development to outside service companies. Along with the 4 operating machines, each capable of 12,000 screens per machine,  it also sells individual kits for researchers whose budgets are constrained.

Soluble Biotech Inc. also specializes in removing, identifying, and isolating endotoxins from products that are used by researchers to culture cells and to help identify endotoxins that maybe hidden within a protective matrix. A notable example is its recent success in completion of a Phase 2 SBIR grant (July 2020 for final report) for the identification of endotoxins in patient samples that have HIV and are experiencing a syndrome known as ‘leaky gut’, where patients in its end result would succumb to septicemia. BioDtech’s detection of the endotoxin in the patient sample, alerts the clinician to start the appropriate therapy ahead of the presentation of the septicemia event. This test also works for patients with Crohn’s disease, ulcerative colitis disease or as a side effect of other drug treatments, such as chemotherapy and radiation. BioDtech’s products include a column of beads that extract endotoxins from samples as well as other kits to release bound endotoxins, improving their detection.

Forward-Looking Statements

Portions of the narrative set for this document that are not statements of historical or current facts are forward-looking statements, in particular, the commercial outlook provided above. Our actual future performance may materially differ from that contemplated by the forward-looking statements as a result of a variety of factors.

These factors include, in addition to those mentioned elsewhere herein:

• We may not be able to continue operating without additional financing;
• Current negative operating cash flows;
• The terms of any further financing, which may be highly dilutive and may include onerous terms;
• Risks related to the 2019 merger with Helomics including; 1) significant goodwill could result in further impairment; 2) possible failure to realize anticipated benefits of the merger; 3) costs associated with the merger may be higher than expected; 4) the merger may result in the disruption of our existing businesses; and 5) distraction of management and diversion of resources;
• Risks related to our partnerships with other companies, including the need to negotiate the definitive agreements; possible failure to realize anticipated benefits of these partnerships; and costs of providing funding to our partner companies, which may never be repaid or provide anticipated returns;
• Risks related to the transaction with Quantitative Medicine including: 1) completion of the transaction; 2) possible failure to realize anticipated benefits of the merger; 3) costs associated with the merger may be higher than expected; 4) the merger may result in the disruption of our existing businesses; and 5) distraction of management and diversion of resources;
• Risk that we will be unable to complete the transaction with InventaBioTech;
• Risk that we will be unable to protect our intellectual property or claims that we are infringing on others’ intellectual property;
• The impact of competition;
• Acquisition and maintenance of any necessary regulatory clearances applicable to applications of our technology;
• Inability to attract or retain qualified senior management personnel, including sales and marketing personnel;
• Risk that we never become profitable if our product is not accepted by potential customers;
• Possible impact of government regulation and scrutiny;
• Unexpected costs and operating deficits, and lower than expected sales and revenues, if any;
• Adverse results of any legal proceedings;
• The volatility of our operating results and financial condition, and,
• Other specific risks that may be alluded to in this report.

Investor Relations Contact:

Hayden IR
James Carbonara
(646)-755-7412
james@haydenir.com

¹ 2015-Freedman et al-The Economics of Reproducibility in Preclinical Research; PLOS Biology DOI:10.1371/journal.pbio.1002165 June 9, 2015

² Endpoint News, June 8, 2020; https://endpts.com/sp/48-billion-is-lost-to-avoidable-experiment-expenditure-every-year/ 

FAQ

What is the significance of Predictive Oncology's first commercial order for ovarian cancer cell culture media?

The order signifies a breakthrough in cancer research, enabling better growth and analysis of ovarian cancer cells from patient-derived samples.

Who placed the first commercial order for Predictive Oncology's ovarian cancer cell media?

A top-rated medical university in New England placed the order.

How does the new ovarian cancer cell culture media benefit researchers?

It retains over 95% of crucial DNA and RNA signatures, improving the reproducibility and accuracy of cancer cell studies.

What challenges does the new media address in ovarian cancer research?

It tackles the difficulties of culturing cells from ascites fluid, which often leads to failures with standard media.

What are the financial concerns mentioned in the press release regarding Predictive Oncology?

The company highlighted ongoing negative operating cash flows, indicating potential financial sustainability issues.