Traders News Source Senior Editor Mark Roberts Interviews J. Melville Engle, CEO and Chairman of the Board, Predictive Oncology (NASDAQ: POAI)
Mr. Engle became POAI’s CEO in 2021 and was appointed to the POAI Board of Directors in 2016. He was elected Chairman of the Board in 2020.
Before Predictive Oncology
Between 2012 and 2021, he was CEO of Engle Strategic Solutions, a consulting and coaching company focused on CEO issues. From 2009 to 2012, he was CEO and Chairman of Thermogenesis, a cell separation company. From 2002 to 2007, he was Regional Head/Director, North America at Merck Generics and CEO of Dey Laboratories, a respiratory company. From 1996 to 2001, he was CEO and Chairman of Anika Therapeutics, an orthobiologics company. From 1980 to 1995, he was with Allergan, Inc., an eye and skin care company, where he served as CFO, Managing Director (living in Toronto), and other positions with the firm.
“ Eliminating cancer is our overall goal. This is not an easy task. We are working hard every day to make this happen, using our novel technology and talented team of employees. ”
Education
University of Southern California
School of Business
MBA, Finance
University of Colorado Boulder
BS, Accounting
Predictive Oncology Inc. (NASDAQ: POAI) Interview with J. Melville Engle, CEO and Chairman of the Board, Predictive Oncology
Full Interview
Could you give us a brief overview and future vision for your company?
Predictive Oncology (NASDAQ: POAI) is a knowledge-driven company, at the forefront of applying artificial intelligence (AI) to develop personalized cancer therapies that improve patient outcomes. We offer a suite of solutions for oncology drug development, from early discovery up to clinical trials. The key products we are selling are: the PeDAL platform that pairs AI with patient tumor samples, in vitro tumor 3D cell models and POAI’s proprietary technologies to solve solubility and stability formulation challenges for large molecule drug developers.
The commercialization efforts underway with this emerging market in drug development are ambitious. With our AI-driven flagship drug discovery platform, PeDAL, we have the ability to predict cancer outcomes with great accuracy. We are the only company in the marketplace that has this proprietary technology that pairs Artificial Intelligence with over 150,000 tumor samples of patient-unique profiles. Because PeDAL can predict with 92% accuracy which tumor samples will respond or not to a particular drug, we have a product that is highly valuable to oncology drug developers. This enables a more informed selection of drug/tumor type combinations to increase the probability of technical success in the clinic. Most importantly, this could lower the cost and time for pharmaceutical and biotech companies during their drug development process.
Our 3D tumor cell models are capable of maintaining cell viability for 30+ days. Our team is in conversations with current and prospective customers. In addition to our existing solution with multiple myeloma models, we have added validated models for breast and pancreatic cancer and are extending the use of our tumor-specific models to offer testing of immuno-oncology therapies. Immuno-oncology is a growing and promising area of oncology, but the technologies to evaluate immuno-oncology agents are currently very limited. POAI’s systems will enable drug developers to evaluate efficiency and potency of immuno-oncology compounds and examine interactions between cancer cells and the immune system. This will expand POAI’s customer footprint and will drive their development of new cancer treatments.
Our formulation solutions and endotoxin removal group is excited to share that the completion date for the GMP facility is set for early September. This means we will have expanded, our ability to support the drug development process through clinical trials. We anticipate strong growth with this product line. In addition to the team’s recent presence at BIO International in San Diego, we will have representation at BIO Europe in October.
How many pharmaceutical companies are using the company’s AI solutions?
We are currently in discussion with several pharmaceutical and biotech companies regarding our PeDAL platform. We additionally work with numerous large pharmaceutical companies on AI that we are not able to disclose due to NDAs and have partners like LabCorp with our other product lines. As we move forward, our goal is to demonstrate our strength with a suite of solutions along the drug development continuum, from early discovery up to clinical trials.
How does POAI market its AI solutions?
We have a new sales and marketing team in place at Predictive Oncology that has been busy preparing and launching plans to market our products. We kicked off our commercialization efforts for PeDAL at BIO International in San Diego, one of the largest industry conferences attended by pharmaceutical and biotech companies looking for solutions to advance their drug development initiatives. The team participated in more than 50 one-on-one partnership meetings and initiated conversations through other networking opportunities at the conference.
POAI is in conversations with numerous potential customers and are creating marketing efforts to be implemented this quarter. We have activated a strategic marketing plan, targeting key decision-makers with prospective customers and have hired a marketing agency, Health Mavens, to support our efforts. We also completed a comprehensive landscape market analysis to better understand specifically how our AI technology fits into the drug development marketplace and we are leveraging that information as we pursue business development opportunities.
Is the company working toward any new product developments or improvements in existing AI solutions?
Our technology is at the forefront of this emerging market. We have just launched the commercialization efforts of PeDAL and anticipate growth over the next two quarters. We also made a recent move to further strengthen Predictive’s scientific and product strategies with the appointment of a Chief Scientific Officer. Dr. Julia Kirshner was elevated from her role as Senior Vice President of Predictive Oncology and President of zPREDICTA, the company she founded and Predictive acquired in the 4th Quarter of 2021. Dr. Kirshner will focus on the integration of Predictive’s product lines and direct the future development of our scientific programs. She will also be working closely with Dr. Pamela Bush, POAI’s SVP of Strategic Sales and Business Development, to identify and meet customer needs, as well as provide expanded solutions along the artificial intelligence and drug development continuum. With their efforts, we look forward to bringing more synergy between our businesses and finding opportunities to provide greater value to our customers.
Does POAI have a patent portfolio? Could you describe the company patents?
Yes, POAI has a patent portfolio. Our patents are segregated by division, which are all Predictive 100% owned subsidiaries. Predictive owns the following patents:
Skyline Medical – 3 U.S. patents for our STREAMWAY System®, which is an automated fluid waste management system; 1 Canadian Patent for the STREAMWAY; 11 International patents for the STREAMWAY including Spain, France, United Kingdom, Italy, Germany, Belgium, Ireland, Netherlands, Norway, Poland and Sweden.
zPREDICTA – 1 U.S. Patent covering the method and apparatus for isolating invasive and metastatic cells for evaluating therapeutics and prediction of metastatic capacity.
Helomics – Patents in the U.S., Australia, Canada, Switzerland, China, Germany, the European Patent Office, Spain, France, the United Kingdom, Israel, Italy Japan and the Patent Cooperation Treaty. Patents predominantly covering CHEMOFX include handling: precise efficacy assay methods for active agents including chemotherapeutic agents; methods for preparing cell cultures from biological specimens for chemotherapeutic and other assays; methods for selecting therapeutic agents for cancer; methods for determining efficacy of chemotherapeutic agents for a patent prior to treatment; methods for determining efficacy of chemotherapeutic agents; methods for culturing and assaying cells; method of preparing cell cultures from biological specimens for assaying a response to an agent; methods for preparing cell cultures from biological specimens for assaying secreted factors; assaying cell marker for the evaluation of tumors; method for using multicellular particulates to analyze malignant or hyperproliferative tissue; methods for assessing efficacy of chemotherapeutic agents; methods for culturing and chemo-sensitivity assays using tumor cells exhibiting persistent phenotypic characteristics; methods for selecting active agents for cancer treatment; methods for simulating chemotherapy for a patient; calibration device and methods for use with a liquid handler; methods and systems for evaluating the sensitivity of resistance of tumor specimens to chemotherapeutic agents; multidrug response for markers for breast cancer cells; biological pathways associated with chemotherapy outcome for breast cancer; methods for predicting a cancer patient’s response to antifolate chemotherapy; prognostic and predictive gene signature for non-small cell lung cancer and adjuvant chemotherapy; shadow file materials and methods for prognosing lung cancer survival; colon cancer gene expression signatures and methods of use; transcriptome microarray technology and methods of using the same; a 3’ based sequencing approach for microarray manufacture; and, transcriptome microarray technology and methods for using the same.
POAI reported lower revenues in Q122 than in the previous quarter. What level of revenues do you anticipate for FYE 2022 as compared to FYE 2021?
Now that we validated our PEDAL platform at a statistically significant 92% drug response accuracy rate, have begun commercialization efforts and are implementing highly targeted marketing initiatives, we expect to begin seeing results of those efforts in the second half of the year. During the first half of the year, POAI has transitioned from a phase of research and development to commercialization with our PeDAL program. PeDAL should see deals signed and begun with pharmaceutical companies in 2022. Some of that revenue may not be recognized until 2023 due to the structure of the deals and GAAP accounting revenue recognition rules. Predictive will have a full year of revenue generated from the sales of the 3D tumor cell models that was not owned by Predictive until November of 2021. This, too, should provide additional revenue for 2022. Finally, Skyline revenues should equal or exceed 2021.
Does any single customer or POAI solution generate most the company’s company revenues?
Not at this point. Some of the Predictive divisions have customers that are consistently purchasing at higher levels than others, but not enough to substantially render a percentage that would put Predictive in a bad position if those customers were to buy elsewhere.
POAI reported $22M in cash at the end of Q122. How long of an operational runway will that cash provide?
At the end of Q2 in 2022 Predictive will show increased cash balances over the previous year. At the Company’s current spending rate, and if zero revenue were reported, the Company could operate for at least 2 more years. A number of considerations extend Predictive’s runway: the Company does generate revenue and will see increases over the months to come; Predictive’s market price is suffering consistent with the entire market current trends, but as deals emerge from PeDAL and our other divisions begin closing deals and increasing revenue our market price should respond positively. The price per share rise should enable multi-million dollar cash exercises from the Company’s warrant shelf, proving enough funds to extend the runway significantly. Lastly, Predictive still has an $8.9M equity line available during 2022. According to our last public raise we cannot utilize the equity line until May 2023.
The POAI share price has remained flat for the past two months. What would you say to investors that could encourage a higher value for the company?
First and foremost, the stock markets are down across the board. Regardless of a market reversal, Predictive has revenue-generating projects either underway or expected to sell by December. There should be a strong positive effect from newly-signed deals expected for our PeDAL product. Predictive has initiated a sales and marketing programs supported by our new marketing firm, Health Mavens. Dr. Julia Kirshner, Predictive’s new Chief Scientific Officer, will coordinate our scientific programs, integrate our research and development and look to synergize Predictive’s current products and services. We look forward to Dr. Kirshner working in the product development strategy and implementation supported by the new Scientific Advisory Board being developed by Dr. Kirshner and members of Predictive’s Board of Directors.
Thank you for your time!
The Traders News Team
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