Predictive Technology Group Reports Third Quarter Fiscal 2019 Financial Results

Nine-month revenue increased 217% to $30 million with $3.1 million in positive cash flow from operations

SALT LAKE CITY, May 21, 2019 (GLOBE NEWSWIRE) — Predictive Technology Group, Inc. (OTC PINK: PRED) (the Company), a leader in the use of data analytics for disease identification and subsequent therapeutic intervention through precision therapeutic treatments, reports financial results for the three and nine months ended March 31, 2019 and provides a business update.

Management Commentary

“I’m pleased to report our 10th consecutive quarter of sequential growth in revenue.  Third quarter fiscal 2019 revenue of $11.3 million was up 167% over the third quarter of fiscal 2018,” said Bradley Robinson, CEO of Predictive Technology Group. “Revenue for the first nine months of fiscal 2019 exceeded $30 million, up 217% over the year-ago period, and we generated $3.1 million in cash flow from operations.    

“We have made exceptional progress in building a strong infrastructure to support the development and commercialization of our proprietary genetic-based diagnostics and therapeutics,” he added. “Predictive Biotech is now operating in our recently opened, state-of-the-art production laboratory and R&D facility that was expanded to meet the production and sales needs of our human cell and tissue products for use in cellular therapies and regenerative medicine. We also finalized the integration of Taueret Laboratories and Inception Dx into Predictive Laboratories, providing us with a CAP/CLIA-accredited laboratory for processing our genetic-based tests. We strengthened our Board with the appointment of independent directors with exceptional industry, public affairs, financial and governance experience. More recently we submitted an application to list Predictive common stock for trading on the NASDAQ, a move that we believe will generate increased visibility and credibility for our Company.” 

Third Quarter and Recent Highlights

Corporate Developments

  • Integrated the sales and marketing team from FlagshipHealth Group, previously a consultant contractor, to support commercial activities for Predictive Biotech and Predictive Laboratories through combined domestic direct sales and a nationwide distributor network.
  • Named Sen. Orrin G. Hatch, Ronald Barhorst and Jay M. Moyes to its Board of Directors, expanding its Board to six including four independent directors.
  • Submitted an application to list its common stock to trade on the NASDAQ.

Predictive Laboratories

  • Completed the acquisition of Taueret Laboratories, LLC, a provider of genetic testing and DNA analysis services through its CAP/CLIA-certified laboratory, to provide for faster entry into the high-growth women’s health testing market with proprietary commercial products.
  • Integrated over $5 million of recently purchased new genomics equipment and supplies into laboratory to expand the technical capabilities and capacities.
  • Appointed Christine Seward, MS, CGC as Senior Vice President of Sales and Marketing of Predictive Laboratories, bringing extensive experience commercializing molecular diagnostics including products in the reproductive space from her 16 years at Myriad Genetics.
  • Announced former Taueret Laboratories Chief Operations Officer Lesa Nelson and Director of Quality Control Debbie Dyckman joined Predictive Laboratories.
  • Launched ARTguide™ genetic test for reproductive endocrinologists into 14 Key Opinion Leader (KOL) clinics to refine the test ordering and reporting processes.
  • Presented a poster titled The Genetic Architecture of Endometriosis at the Society for Reproductive Investigation (SRI) meeting, demonstrating the ability of the proprietary genetic test ENDORisk™ to segregate patients with endometriosis from those without in the Caucasian population with a high degree of sensitivity (Area Under the ROC Curve = 0.91). The mean genetic risk score for endometriosis was 1.6 in the general population versus 5.3 in endometriosis patients, determined to be statistically significant with a p-value of less than 0.001.

Predictive Biotech

  • Reported 10th consecutive quarter-over-quarter revenue growth.
  • Completed buildout of a new 2,000-square-foot production laboratory and R&D facility meeting good manufacturing Practice (GMP) and Good Tissue Practice (GTP) requirements for Predictive Biotech. The lab features an ISO 7 cleanroom and 18 ISO 5 production hoods.

Third Quarter Fiscal 2019 Results

Revenue for the third quarter of fiscal 2019 was $11.3 million, an increase of 167% from $4.2 million for the third quarter of fiscal 2018. The increase was due to continued growth in the sales volume and increasing demand for human cell and tissue products. 

Gross profit margin for the third quarter of fiscal 2019 was 57.7%, compared with 57.6% for the prior-year period.

Sales, marketing and administrative (SG&A) expenses for the third quarter of fiscal 2019 were $7.9 million, compared with $5.7 million for the prior-year quarter. The increase was primarily due to higher headcount in accounting, marketing, administrative support and other functions necessary to support growth.

Research and development (R&D) expenses for the third quarter of fiscal 2019 were $1.5 million, compared with $367,000 a year ago, with the increase primarily driven by higher spending to develop improved processing methods for the Company’s human cell and tissue products, as well as continued development of diagnostic products.

Amortization and depreciation expenses for the third quarter of fiscal 2019 were $2.4 million, compared with $1.1 million for the prior-year period, with the increase primarily due to an increase in the intangible asset portfolio arising from the business combinations and asset acquisition.

The net loss attributable to controlling interest for the third quarter of fiscal 2019 was $3.7 million, or $0.01 per share, compared with a net loss attributable to controlling interest for the third quarter of fiscal 2018 of $3.2 million, or $0.01 per share.

Year-to-date Financial Results

Revenue for the first nine months of fiscal 2019 was $30.0 million, a 217% increase from $9.5 million for the first nine months of fiscal 2018. Gross profit margin for first nine months of fiscal 2019 was 63.8%, an improvement from 62.5% from the prior-year period.

SG&A expenses for the nine months ended March 31, 2019 were $19.1 million, compared with $14.7 million for the nine months ended March 31, 2018, with the increase due to higher headcount in sales and general and administrative functions as the Company continues to expand, as well as increasing public company compliance costs.

R&D expenses for the first nine months of fiscal 2019 were $3.8 million, compared with $417,000 for the prior-year period, with the increase due to costs related to internal development of existing products, and an increased focus in developing DNA diagnostics and new methods for processing tissues.

Depreciation and amortization expenses for the nine months ended March 31, 2019 were $6.1 million, compared with $3.4 million for the prior-year period, with the increase primarily due to a laboratory buildout and related laboratory equipment purchases, computer hardware and software purchases, and intangible assets arising from acquisitions.

Other expense, net for the nine months ended March 31, 2019 was $832,000, compared with other income, net of $178,000 for the prior-year period. The change was primarily driven by increased losses from equity method investment caused by increasing ownership in Juneau Biosciences, LLC, partially offset by the bargain purchase gain arising from the acquisition of Taueret Laboratories, LLC.

The net loss attributable to controlling interest for the first nine months of fiscal 2019 was $8.0 million, or $0.03 per share, versus a net loss attributable to controlling interest for the first nine months of fiscal 2018 of $7.5 million, or $0.03 per share. 

Cash and cash equivalents as of March 31, 2019 were $1.8 million, compared with $1.2 million as of June 30, 2018. Cash provided by operating activities for or the nine months ended March 31, 2019 was $3.1 million, a $5.7 million improvement from cash used in operating activities of $2.6 million for the nine months ended March 31, 2018.

Revisions of Previously Issued Financial Statements:  During the financial close for the third fiscal quarter of 2019 the Company discovered errors in the Company’s accounting for income taxes, primarily with regard to impact of income taxes on the Company’s accounting for business combinations and asset acquisitions.  The errors were determined to be material to the Company’s consolidated balance sheets, consolidated statements of operations, consolidated statement of stockholders’ equity, and statements of cash flows for the years ended June 30, 2018 and June 30, 2017.  The financial information for prior periods has been restated to reflect these adjustments.

About Predictive Biotech, Inc.
Predictive Biotech, Inc., a Salt Lake City life sciences company formed in 2015, is a leader in human cell and tissue products for use in cellular therapies and regenerative medicine. A growing national network of clinics, health systems, researchers and physicians leverage Predictive’s four main placental-derived and Wharton’s jelly umbilical cord-derived products. Predictive Biotech’s current products are regulated by the FDA under 21 CFR part 1271 section 361 as minimally manipulated allografts intended for homologous use.

About Predictive Laboratories, Inc.
Predictive Laboratories owns significant next-generation sequencing and genotyping assets along with extensive protocols, quality and laboratory management systems and other resources required by a “high complexity” molecular diagnostic laboratory operating under the Clinical Laboratory Improvement Act (CLIA). In 2018 this group launched its novel test for women experiencing infertility, called ARTGuide™, to select beta launch centers. ARTGuide™ is a proprietary gene test panel for women experiencing infertility as a result of endometriosis and other health concerns. The test is expected to change the way that advanced reproductive technologies such as in vitro fertilization (IVF) are used to assist couples having difficulty conceiving a pregnancy.

About Predictive Technology Group, Inc.
Predictive Technology Group aims to revolutionize patient care through predictive data analytics, novel gene-based diagnostics and companion therapeutics through its subsidiaries Predictive Therapeutics, Predictive Biotech, and Predictive Laboratories.  These subsidiaries are focused on endometriosis, scoliosis, degenerative disc disease and human cell and tissue products.  The subsidiaries use genetic and other information as cornerstones in the development of new diagnostics that assess a person’s risk of illness and therapeutic products designed to identify, prevent and treat diseases more effectively.  Additional information is available at Predtechgroup.com; Predrx.com; Predictivebiotech.com; and Predictivelabs.com.

Forward-Looking Statements
This release contains “forward-looking” statements that are based on present circumstances and on Predictive Technology Group’s predictions with respect to events that have not occurred, that may not occur, or that may occur with different consequences and timing than those now assumed or anticipated. Such forward-looking statements and any statements of the plans and objectives of management for future operations and forecasts of future growth and value, are not guarantees of future performance or results and involve risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements. Such forward-looking statements are made only as of the date of this release and Predictive Technology Group assumes no obligation to update forward-looking statements to reflect subsequent events or circumstances. Readers should not place undue reliance on these forward-looking statements. The information in this press release should be read in conjunction with, and is modified in its entirety by, the Registration Statement on Form 10 (the “Form 10”) filed by the Predictive Technology Group with the Securities and Exchange Commission (the “SEC”) and all of the Company’s other public filings with the SEC (the “Public Filings”). In particular, the financial information contained herein is subject to and qualified by reference to the financial statements contained in the Form 10 and Public Filings, the footnotes thereto and the limitations set forth therein. Investors may not rely on the press release without reference to the Form 10 and the Public Filings.

FINANICAL REPORTS At
https://www.sec.gov/Archives/edgar/data/1382943/000109181819000157/pred05182019form10qmarch.htm

PREDICTIVE BIOTECH SIGNS LETTER OF INTENT WITH IQVIA TO BEGIN CLINCIAL TRIAL FOR OSTEOARTHRITIS OF THE KNEE

Company shifts focus of human cell and tissue products to biopharmaceuticals

SALT LAKE CITY (May 14, 2019) – Predictive Technology Group, Inc. (OTC PINK: PRED), a leader in the use of data analytics for disease identification and subsequent precision therapeutic intervention, announces the signing of a letter of intent with IQVIA (Formerly Quintiles and IMS) to guide the regulatory strategy for its wholly owned subsidiary Predictive Biotech. This collaboration will accelerate the process of identifying and executing the appropriate regulatory pathways for the Company’s existing products and future product candidates.

Specifically, IQVIA will guide Predictive Biotech in its U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) application and subsequent clinical trial for osteoarthritis (OA) of the knee. The Company expects to meet with the FDA during the third quarter of 2019 to discuss the submission of the IND with the objective of  determining the safety and effectiveness of CoreCyte™ compared to a placebo control for treatment of OA of the knee. The Company will work with the FDA to determine if the FDA will accept the current safety data from over 75,000 patients previously treated with CoreCyte™.

Eric Olson, Predictive Biotech President and CEO, said, “This OA of the knee study is the first of several trials that Predictive Biotech intends to conduct for our cellular therapy injectable products. We are excited to leverage IQVIA’s expertise as we expand our focus from human cell and tissue products (HCT/Ps) into the biopharmaceutical market.”

Given the lack of effective treatment options for patients with OA of the knee, and the high risks associated with using opioids to manage pain, the Company anticipates seeking an accelerated Regenerative Medicine Advanced Therapy (RMAT) designation.

“CoreCyte™ has the opportunity to address a significant unmet clinical need by providing an alternative to opioids, cortisone and/or hyaluronic injections for treating OA knee pain,” added Olson.

About Predictive Technology Group, Inc.

Predictive Technology Group aims to revolutionize patient care through predictive data analytics, novel gene-based diagnostics and companion therapeutics through its subsidiaries Predictive Therapeutics, Predictive Biotech, and Predictive Laboratories. These subsidiaries are focused on endometriosis, scoliosis, degenerative disc disease and human cell and tissue products. The subsidiaries use genetic and other information as cornerstones in the development of new diagnostics that assess a person’s risk of illness and therapeutic products designed to identify, prevent and treat diseases more effectively. Additional information is available at Predtechgroup.com; Predrx.com; Predictivebiotech.com; and Predictivelabs.com.

About Predictive Biotech, Inc.

Predictive Biotech, Inc., a Salt Lake City, UT life sciences Company formed in 2015, is a leader in human cell and tissue products for use in cellular therapies and regenerative medicine. A growing national network of clinics, health systems, researchers and physicians leverage Predictive’s four main placental-derived and Wharton’s Jelly umbilical cord-derived products. Predictive Biotech’s current products are regulated by the FDA under 21 CFR part 1271 section 361 as minimally manipulated allografts intended for homologous use.

Forward-Looking Statements

To the extent any statements made in this release contain information that is not historical, these statements are essentially forward-looking and are subject to risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for human cell and tissue products and other pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, availability of additional intellectual property rights, availability of future financing sources, the regulatory environment, and other risks the Company may identify from time to time in the future.

PREDICTIVE TECHNOLOGY GROUP FINALIZES BOARD COMMITTEE CHAIR APPOINTMENTS

SALT LAKE CITY (May 9, 2019) – Predictive Technology Group, Inc. (OTC PINK: PRED), a leader in the use of data analytics for disease identification and subsequent clinical intervention through precision therapeutic treatments, announces Board of Director Committee Chair appointments.

Predictive’s Board of Directors, at its quarterly board meeting held May 8, 2019, finalized important committee appointments.  Predictive Chairman of the Board John Sorrentino announced the following: 

  • Audit Committee and Compliance Committee Chair is Jay Moyes
  • Nominating Committee Chair is John Sorrentino
  • Compensation Committee Chair is Ron Barhorst

“The Board made great strides in setting the future course of Predictive Technology Group by filling these important roles and welcoming new board members Senator Orrin Hatch, Jay Moyes and Ron Barhorst,” said Mr. Sorrentino.

About Predictive Technology Group, Inc.

Predictive Technology Group aims to revolutionize patient care through predictive data analytics, novel gene-based diagnostics and companion therapeutics through its subsidiaries Predictive Therapeutics, Predictive Biotech, and Predictive Laboratories. These subsidiaries are focused on endometriosis, scoliosis, degenerative disc disease, and human cell and tissue products. The subsidiaries use genetic and other information as cornerstones in the development of new diagnostics that assess a person’s risk of illness and therapeutic products designed to identify, prevent and treat diseases more effectively. Additional information is available at Predtechgroup.com, Predrx.com, Predictivebiotech.com, and Predictivelabs.com.

Forward-Looking Statements

To the extent any statements made in this release contain information that is not historical, these statements are essentially forward-looking and are subject to risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for human cell and tissue products and other pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, availability of additional intellectual property rights, availability of future financing sources, the regulatory environment, and other risks the Company may identify from time to time in the future.



PREDICTIVE TECHNOLOGY GROUP ANNOUNCES ENROLLMENT MILESTONE OF 200 PARTICIPANTS IN PREDICTIVE LABORATORIES’ STUDY FOR CHRONIC JOINT AND SPINE PAIN

SALT LAKE CITY (May 7, 2019) – Predictive Technology Group, Inc. (OTC PINK: PRED), a leader in the use of data analytics for disease identification and subsequent precision therapeutic intervention, announces its wholly owned subsidiary Predictive Laboratories has reached an enrollment milestone of 200 participants in its ongoing Institutional Review Board (IRB)-approved study of spine and joint disease leading to chronic pain. 

The primary objective of the IRB study is to conduct genetic research related to healthcare advancement in the diagnosis, treatment and prevention of conditions causing chronic pain. The first 200 participants have volunteered for the study by submitting their DNA samples to the Predictive Biorepository and by reporting detailed medical information through their healthcare providers.

One in five American adults suffer with chronic pain and the use of opioids to address pain has led to an epidemic of addiction and overdose as sufferers attempt to find relief,” said Bradley Robinson, CEO of Predictive Technology Group. “Patients have embraced the opportunity to enroll in this research study and participate in the search for a better solution to chronic pain. The Predictive Biorepository’s genetic and analytic capabilities are expected to add to an already robust pipeline of genetic data that will assist in the ongoing discovery of diagnostic tests and therapeutic treatments for disease.”

“We are excited about achieving this initial milestone as we work to build a foundation for the advancement of medicine to solve real problems for real people,” said Rick W. Obray, M.D., Chairman of Predictive’s Clinical Advisory Board. “Establishing these genetic building blocks is truly how the promise of personalized medicine will move toward reality.”

Predictive Laboratories, Inc. is the sponsor of the study. Kenneth Ward, MD, Laboratory Director of Predictive Laboratories, serves as Principal Investigator.

About Predictive Technology Group, Inc.

Predictive Technology Group aims to revolutionize patient care through predictive data analytics, novel gene-based diagnostics and companion therapeutics through its subsidiaries Predictive Therapeutics, Predictive Biotech, and Predictive Laboratories. These subsidiaries are focused on endometriosis, scoliosis, degenerative disc disease and human cell and tissue products. The subsidiaries use genetic and other information as cornerstones in the development of new diagnostics that assess a person’s risk of illness and therapeutic products designed to identify, prevent and treat diseases more effectively. Additional information is available at Predtechgroup.com; Predrx.com; Predictivebiotech.com; and Predictivelabs.com.

About Predictive Laboratories, Inc.

Predictive Laboratories owns significant next-generation sequencing and genotyping assets along with extensive protocols, quality and laboratory management systems and other resources required by a “high complexity” molecular diagnostic laboratory operating under the Clinical Laboratory Improvement Act (CLIA). The group recently launched its novel test for women experiencing infertility, called ARTGuide®, to selected Beta launch centers. ARTGuide™ is a proprietary gene test panel for women experiencing infertility as a result of endometriosis and other health concerns, in 2018. The test is expected to change the way that Advanced Reproductive Technologies (ART), such as in vitro fertilization (IVF), are used to assist couples having difficulty conceiving a pregnancy.

Forward-Looking Statements:

To the extent any statements made in this release contain information that is not historical, these statements are essentially forward-looking and are subject to risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for human cell and tissue products and other pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, availability of additional intellectual property rights, availability of future financing sources, the regulatory environment, and other risks the Company may identify from time to time in the future.

Predictive Technology Group Completes Integration of Taueret Laboratories and Inception Dx into its Subsidiary, Predictive Laboratories

SALT LAKE CITY (April 30, 2019) Predictive Technology Group, Inc. (OTC PINK: PRED), a leader in the use of data analytics for disease identification and subsequent clinical intervention through precision therapeutic treatments, announces that it has completed the integration of two acquired DNA laboratories into the Predictive subsidiary, Predicative Laboratories. Predictive announced the acquisitions of CLIA-approved Taueret Laboratories in March 2019 and Inception Dx in September 2018.

Based in Salt Lake City, Predictive Laboratories runs a state-of-the-art molecular laboratory initially focusing on human infertility and women’s health. Twenty-three skilled employees are performing high-complexity, proprietary laboratory tests. Predictive Laboratories recently purchased $6 million in new genomics equipment and supplies to expand the technical capabilities and capacities. Lab renovation will begin immediately to improve workflow efficiency. The laboratory’s new Federal CLIA number became effective today (46D1077919).

“The integration of the Taueret Laboratories team into Predictive Laboratories was completed much faster than anticipated,” said Bradley Robinson, CEO of Predictive Technology Group. “I am excited to have this highly experienced team working to create a leading state-of-the-art laboratory in reproductive health.”

In addition to his position as CEO of Juneau Biosciences, Kenneth Ward, M.D. will assume the role of Laboratory Director of Predictive Laboratories. Dr. Ward is Board Certified in four specialties including Obstetrics and Gynecology, Maternal-Fetal Medicine, Medical Genetics and Molecular Genetics. Dr. Ward has run DNA diagnostic laboratories for 33 years and is internationally known in the field of Human Genetics. Predictive previously licensed endometriosis-related diagnostic intellectual property from Juneau on which Dr. Ward is an inventor.

Paul Evans, JD, MBA, will serve as interim CEO of Predictive Laboratories in addition to his positon as Chief Operating Officer of Predictive Technology Group. He brings more than 20 years of experience in business and corporate development roles and has been a trusted advisor to boards of directors, executive management teams and investors throughout his career with a variety of small to large private and public healthcare and technology companies.

Justine Coppinger, M.S., a Board-Certified Genetic Counselor, serves as Director of Clinical Affairs of Predictive Laboratories, bringing more than 20 years of experience in clinical and diagnostic laboratory settings. Ms. Coppinger previously served in management roles at Taueret, Assuragen, and Signature Genomics, the first commercial clinical laboratory to introduce microarray molecular cytogenetics testing.

Rakesh Chettier, M.S. will serve as Director of Bioinformatics. He brings more than 13 years of industry experience and a strong track record of scientific publications and issued patents.

As announced last week, Christine Seward, MS, CGC, joins Predictive Laboratories as Senior Vice President of Sales and Marketing. Ms. Seward brings extensive experience commercializing molecular diagnostics including products in the reproductive space from her 18-year tenure at Myriad Genetic Laboratories.  Lesa Nelson serves as Chief Operations Officer and has more than 30 years of experience in Human Molecular Genetics. Debbie Dyckman will serve as Director of Quality Assurance.

Predictive Laboratories voluntarily participates in proficiency testing programs and adheres to strict accreditation standards and practices of the College of American Pathologists (CAP), the Clinical Laboratory Improvement Amendments of ‘88 (CLIA), and all applicable state licensing. 

About Predictive Technology Group, Inc.
Predictive Technology Group aims to revolutionize patient care through predictive data analytics, novel gene-based diagnostics and companion therapeutics through its subsidiaries Predictive Therapeutics, Predictive Biotech, and Predictive Laboratories. These subsidiaries are focused on endometriosis, scoliosis, degenerative disc disease and human cell and tissue products. The subsidiaries use genetic and other information as cornerstones in the development of new diagnostics that assess a person’s risk of illness and therapeutic products designed to identify, prevent and treat diseases more effectively. Additional information is available at Predtechgroup.com; Predrx.com; Predictivebiotech.com; and Predictivelabs.com. 

Forward-Looking Statements
To the extent any statements made in this release contain information that is not historical, these statements are essentially forward-looking and are subject to risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for human cell and tissue products and other pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, availability of additional intellectual property rights, availability of future financing sources, the regulatory environment, and other risks the Company may identify from time to time in the future.

Predictive Technology Group Names Christine Seward Senior Vice President of Sales and Marketing of Predictive Laboratories

Former Taueret Laboratories Chief Operations Officer Lesa Nelson and Director of Quality Assurance Debbie Dyckman Join Predictive Laboratories

SALT LAKE CITY, April 25, 2019 (GLOBE NEWSWIRE) — Predictive Technology Group, Inc. (OTC PINK: PRED), a leader in the use of data analytics for disease identification and subsequent clinical intervention through precision therapeutic treatments, announces that Christine Seward, MS, CGC, has joined Predictive Laboratories as Senior Vice President of Sales and Marketing. Ms. Seward brings extensive experience commercializing molecular diagnostics including products in the reproductive space from her 16-year tenure at Myriad Genetics.

Predictive Laboratories also announces the appointments of Lesa Nelson as Chief Operations Officer and Debbie Dyckman as Director of Quality Assurance of Predictive Laboratories. Both Ms. Nelson and Ms. Dyckman previously served in the same capacity at Taueret Laboratories, which was acquired by Predictive in March 2019. Ms. Nelson, who has 27 years in human genetic research including more than 20 years in senior management positions, directs all operational activities and serves as the laboratory Technical Supervisor at Predictive Laboratories. Ms. Dyckman has more than 15 years of experience in clinical trials research and quality assurance and is responsible for licensing, accreditation, document control, lab safety, internal and external inspections, quality assurance reviews and audits, and CAPA management at Predictive Laboratories.

“We are delighted to attract these highly qualified professionals as we expand our genetic testing capabilities with an initial focus on human infertility and women’s health,” said Bradley Robinson, CEO of Predictive Technology Group. “Christine is highly accomplished in driving the commercial growth of molecular diagnostics with a history of successfully developing and executing product launches and negotiating contracts that exceeded growth targets. Lesa and Debbie have worked with Predictive through our prior relationship with Taueret Laboratories and bring direct, proven expertise that will be invaluable in the expansion of our state-of-the-art laboratory operations.”

Ms. Seward served in various positions with increasing responsibility at Myriad Genetics, most recently as Senior Strategic Product Director – Payer Markets. In this position, she was responsible for collaborating and aligning with a cross-functional team to develop peer-reviewed publications and developing innovative study designs to demonstrate the clinical validity, utility and cost-effectiveness of Myriad products including for reproductive health. Among prior positions at Myriad, she served as Director of Elevate 2020; Director of Marketing, Oncology Biomarkers; Senior Sales Representation; and Medical Specialist. Prior to joining Myriad, Ms. Seward was an oncology genetic counselor at the University of Virginia Health System. Ms. Seward received a Master of Science in Genetic Counseling from California State University, Northridge, and is board certified by the American Board of Genetic Counseling.

Ms. Nelson previously was Vice President of Clinical Operations for Axial, Biotech, Inc., a company focused on developing and commercializing genetic tests and treatment solutions for spinal disorders. Ms. Nelson is an active member of the American Association of Human Genetics (ASHG), the American Association of Blood Banks (AABB) and the Association of Molecular Pathologists (AMP). She has authored or co-authored more than 40 human genetics-related articles and scientific papers published in various peer-reviewed medical periodicals, and is a named inventor in three U.S. patents and five published U.S. patent applications related to the diagnosis and prognosis of human genetic conditions.

Ms. Dyckman previously served as Quality Assurance Supervisor at Affiliated Genetic and at Axial Biotech.  In these prior positions, she was responsible for controlling standard operating procedures, and managing licenses and accreditations.  Before that she was a Site Start-up Specialist at Quintiles (now IQVIA), where she was responsible for negotiating contracts and budgets, and guiding sites through their scientific review and approval processes. She graduated from the Medical Technology Program at Utah State University, the Lab Tech program at Claremont Mesa College and the Clinical Trial Research – AAS program at Durham Technical Community College.

About Predictive Laboratories, Inc.
Predictive Laboratories owns significant next-generation sequencing and genotyping assets along with extensive protocols, quality and laboratory management systems and other resources required by a “high complexity” molecular diagnostic laboratory operating under the Clinical Laboratory Improvement Act (CLIA). The group recently launched its novel test for women experiencing infertility, called ARTGuide™, to selected Beta launch centers. ARTGuide™ is a proprietary gene test panel for women experiencing infertility as a result of endometriosis and other health concerns, in 2018. The test is expected to change the way that Advanced Reproductive Technologies (ART), such as in vitro fertilization (IVF), are used to assist couples having difficulty conceiving a pregnancy.

About Predictive Technology Group, Inc.
Predictive Technology Group aims to revolutionize patient care through predictive data analytics, novel gene-based diagnostics and companion therapeutics through its subsidiaries Predictive Therapeutics, Predictive Biotech, and Predictive Laboratories. These subsidiaries are focused on endometriosis, scoliosis, degenerative disc disease and human cell and tissue products. The subsidiaries use genetic and other information as cornerstones in the development of new diagnostics that assess a person’s risk of illness and therapeutic products designed to identify, prevent and treat diseases more effectively. Additional information is available at Predtechgroup.com; Predrx.com; Predictivebiotech.com; and Predictivelabs.com.

Forward-Looking Statements
To the extent any statements made in this release contain information that is not historical, these statements are essentially forward-looking and are subject to risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for human cell and tissue products and other pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, availability of additional intellectual property rights, availability of future financing sources, the regulatory environment, and other risks the Company may identify from time to time in the future.

Predictive Technology Group Integrates Sales and Marketing Team from FlagshipHealth Group

Move Accelerates Commercialization of Subsidiary Companies’ Products

SALT LAKE CITY, April 23, 2019  — Predictive Technology Group, Inc. (OTC PINK: PRED), a leader in the use of data analytics for disease identification and subsequent clinical intervention through precision therapeutic treatments, announces that it has integrated the sales and marketing team from FlagshipHealth Group, a Predictive consultant contractor. This strategic move is expected to ensure control and growth of sales and marketing efforts for its subsidiary companies, Predictive Biotech and Predictive Laboratories. The integration will enable Predictive and its subsidiaries to combine their domestic direct sales and nationwide distributor network with the sales and marketing team that has joined Predictive from Flagship.

FlagshipHealth Group, a Minneapolis-based provider of strategic sales and consulting services for the healthcare industry, has worked with Predictive Technology Group subsidiary companies to provide guidance and early development of their commercialization strategies. Both Predictive Biotech and Predictive Laboratories have leveraged the collective professional network and relationship capital of FlagshipHealth Group to drive commercial sales, business development and deeper engagement of healthcare stakeholders.

“We are pleased to have the sales and marketing team join the Predictive organization as full-time employees,” said Bradley Robinson, CEO of Predictive Technology Group. “Flagship’s diligence and commitment over the past two years have assisted Predictive in building a strong national sales and distribution team in a short period of time. As we move forward to fully address important challenges, such as clinical trial research for certain indications and reimbursement strategies, we are fortunate to have a team that has demonstrated a tremendous understanding of the complexity and stakeholder diversity of Predictive’s subsidiaries and their markets.”

Michael Herbert, a seasoned marketing professional, has served as Predictive Technology Group’s Executive Vice President since January of 2017. With this integration, Herbert will no longer hold the dual role as Flagship’s Chief Marketing Officer and will focus exclusively on Predictive. In addition to his EVP duties, Hebert will serve as Chief Sales and Marketing Officer for Predictive Biotech on an interim basis.

“We are excited to have Michael join Predictive on a full-time basis, as he brings broad sales and marketing expertise in key areas of healthcare, including human cell and tissue products, molecular diagnostic technologies and patient consumerism,” said Robinson.

About Predictive Technology Group, Inc.
Predictive Technology Group aims to revolutionize patient care through predictive data analytics, novel gene-based diagnostics and companion therapeutics through its subsidiaries Predictive Therapeutics, Predictive Biotech, and Predictive Laboratories. These subsidiaries are focused on endometriosis, scoliosis, degenerative disc disease and human cell and tissue products. The subsidiaries use genetic and other information as cornerstones in the development of new diagnostics that assess a person’s risk of illness and therapeutic products designed to identify, prevent and treat diseases more effectively. Additional information is available at Predtechgroup.com; Predrx.com; Predictivebiotech.com; and Predictivelabs.com.

Forward-Looking Statements
To the extent any statements made in this release contain information that is not historical, these statements are essentially forward-looking and are subject to risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for human cell and tissue products and other pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, availability of additional intellectual property rights, availability of future financing sources, the regulatory environment, and other risks the Company may identify from time to time in the future.

Predictive Technology Group Announces Lab Expansion and New Research and Development Facility for Subsidiary, Predictive Biotech

Expansion of ISO 7, GMP/GTP lab allows for continued scale of production to meet demand, and new R&D facility accelerates product expansion

SALT LAKE CITY, March 28, 2019 (GLOBE NEWSWIRE) — Predictive Technology Group, Inc. (OTC PINK: PRED), a leader in the use of data analytics for disease identification and subsequent precision therapeutic intervention, announces it has completed the buildout of a new production laboratory and R&D facility for its subsidiary company, Predictive Biotech.

The newly renovated 22,000 square foot facility, located in Research Park on the University of Utah’s campus, features an ISO 7 cleanroom and 18 ISO 5 production hoods.  The lab meets Good Manufacturing Practice (GMP) and Good Tissue Practice (GTP) requirements. Environmental testing for the new lab is completed and the lab is expected to be on-line by the first week of April.  The production space previously used for the production of Predictive Biotech products will transition into a new research and product development lab headed by Predictive’s Chief Laboratory Officer Doug Schmid, PhD.

“We are very pleased with completion of the lab expansion. This new facility allows us to continue to scale to meet production and sales needs. The lab has been under construction over the past few months and we look forward to bringing it on-line next week,” said Eric Olson, CEO of Predictive Biotech.

“Our new R&D facility allows us to accelerate product development and explore new areas that will add to all of our portfolio companies,” added Bradley Robinson, CEO of Predictive Technology Group.

About Predictive Biotech, Inc.
Predictive Biotech, a Salt Lake City-based life sciences company formed in 2015, is a leader in human cell and tissue products for use in regenerative medicine. A growing national network of clinics, health systems, researchers and physicians leverage Predictive’s four main placental-derived and Wharton’s Jelly umbilical cord-derived products. Predictive Biotech’s current products are regulated by the FDA under 21 CFR part 1271 section 361 as minimally manipulated allografts intended for homologous use.

About Predictive Technology Group, Inc.
Predictive Technology Group aims to revolutionize patient care through predictive data analytics, novel gene-based diagnostics and companion therapeutics through its subsidiaries Predictive Therapeutics, Predictive Biotech, and Predictive Laboratories.  These subsidiaries are focused on endometriosis, scoliosis, degenerative disc disease and human cell and tissue products.  The subsidiaries use genetic and other information as cornerstones in the development of new diagnostics that assess a person’s risk of illness and therapeutic products designed to identify, prevent and treat diseases more effectively.  Additional information is available at Predtechgroup.com; Predrx.com; Predictivebiotech.com; and Predictivelabs.com.

Forward-Looking Statements
To the extent any statements made in this release contain information that is not historical, these statements are essentially forward-looking and are subject to risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for human cell and tissue products and other pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, availability of additional intellectual property rights, availability of future financing sources, the regulatory environment, and other risks the Company may identify from time to time in the future.

Figure 4_Expanded R&D

Predictive’s research and product development lab.

Figure 1_outside_lab

Exterior of Predictive Biotech located in Research Park on the University of Utah’s campus.

Figure 2_R&D clean room

Cleanroom in Predictive Biotech R&D facility.

Figure 3_New Clean Room

Newly constructed laboratory is a part of a 22,000 square foot facility expansion, including an ISO 7 cleanroom for tissue processing.

 

Four photos accompanying this announcement are available at:

http://www.globenewswire.com/NewsRoom/AttachmentNg/af5c9511-9709-4fe4-8ef7-6cbd93b0ef8c

http://www.globenewswire.com/NewsRoom/AttachmentNg/feeeda85-5b55-4c5c-8146-2d8eb8b2f814

http://www.globenewswire.com/NewsRoom/AttachmentNg/f2353467-4aa8-4532-ba30-5730a515afbe

http://www.globenewswire.com/NewsRoom/AttachmentNg/d8a3c56d-790a-4d0c-9d25-221d1ee20ce4

Predictive Technology Group Completes Acquisition of Taueret Laboratories

Addition of CAP/CLIA laboratory and experienced diagnostics team form an unparalleled molecular clinical and research facility to accelerate new product development, commercialization and scale

SALT LAKE CITY, March 26, 2019- Predictive Technology Group, Inc. (OTC PINK: PRED), a leader in the use of data analytics for disease identification and subsequent therapeutic intervention through precision therapeutic treatments, announces it has completed the acquisition of Taueret Laboratories, LLC, a clinical and research molecular laboratory, for $9,747,800, with $1,200,000 paid at closing in the form of the Company’s restricted common stock and $8,547,800 to be paid on or before December 31, 2020, subject to certain conditions. Taueret Laboratories will join Predictive Technology Group’s newest subsidiary Predictive Laboratories.

“With the completion of this acquisition and addition of a highly experienced staff, we have formed an unparalleled molecular clinical and research facility to support our objectives of commercializing novel diagnostics based on predictive analytics and extensive genetic information,” said Bradley C. Robinson, CEO of Predictive Technology Group. “Our teams at Predictive and Taueret have been collaborating for more than a decade and our use of the Taueret laboratory was instrumental in developing the ARTguide™ test, our proprietary test for endometriosis. We are excited to welcome Taueret’s executive and clinical laboratory teams, who are joining Predictive Laboratories in similar roles and bringing us more than 125 years of combined experience in validating, launching and running DNA diagnostic tests.

“We plan the immediate use of our laboratory to develop a suite of new clinical tests for the reproductive health market,” Robinson added. “We expect this newly acquired laboratory to accelerate the commercialization of our current tests and provide additional capacity as our tests gain momentum.”

In conjunction with the acquisition, Predictive invested $4.2 million in new laboratory instrumentation and resources to bolster capabilities in the 15,000-square-foot laboratory and administrative campus, which now contains all necessary infrastructure for the Company’s clinical operations.

About Taueret Laboratories, LLC
Taueret Laboratories is a privately held molecular laboratory focusing on human infertility, women’s health, and childhood diseases and performs genetic testing using state-of-the-art instrumentation. The clinical leadership team includes Laboratory Director Kenneth Ward, M.D. who is Board Certified in four specialties including Obstetrics and Gynecology, Maternal-Fetal Medicine, Medical Genetics, and Molecular Genetics. Dr. Ward has run DNA diagnostic laboratories for more than 32 years and is internationally known in the field of human genetics. Lesa Nelson serves as Chief Operations Officer and has more than 30 years of experience in Human Molecular Genetics. Justine Coppinger, M.S., a Board-Certified Genetic Counselor, serves as Director of Clinical Affairs and brings more than 20 years of experience in clinical and diagnostic laboratory settings. Taueret Laboratories voluntarily participates in proficiency testing programs and adheres to strict accreditation standards and practices of the College of American Pathologists (CAP), the Clinical Laboratory Improvement Amendments of ‘88 (CLIA), and all applicable state licensing. Taueret has held continuous CAP / CLIA accreditation for more than a decade.

About Predictive Laboratories, Inc.
Predictive Laboratories owns significant next-generation sequencing and genotyping assets along with extensive protocols, quality and laboratory management systems and other resources required by a “high complexity” molecular diagnostic laboratory operating under the Clinical Laboratory Improvement Act (CLIA). In 2018 this group launched its novel test for women experiencing infertility, called ARTGuide®, to selected beta launch centers. ARTGuide™ is a proprietary gene test panel for women experiencing infertility as a result of endometriosis and other health concerns. The test is expected to change the way that Advanced Reproductive Technologies (ART), such as in vitro fertilization (IVF), are used to assist couples having difficulty conceiving a pregnancy.

About Predictive Technology Group, Inc.
Predictive Technology Group aims to revolutionize patient care through predictive data analytics, novel gene-based diagnostics and companion therapeutics through its subsidiaries Predictive Therapeutics, Predictive Biotech, and Predictive Laboratories. These subsidiaries are focused on endometriosis, scoliosis, degenerative disc disease and human cell and tissue products. The subsidiaries use genetic and other information as cornerstones in the development of new diagnostics that assess a person’s risk of illness and therapeutic products designed to identify, prevent and treat diseases more effectively. Additional information is available at Predtechgroup.com; Predrx.com; Predictivebiotech.com; and Predictivelabs.com.

Forward-Looking Statements
To the extent any statements made in this release contain information that is not historical, these statements are essentially forward-looking and are subject to risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for human cell and tissue products and other pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, availability of additional intellectual property rights, availability of future financing sources, the regulatory environment, and other risks the Company may identify from time to time in the future

 

Predictive Technology Group Names Senator Orrin G. Hatch and Ronald Barhorst to Its Board of Directors

 Seven-term U.S. Senator and 25-year financial services executive bring considerable legal, financial and governance expertise to the Board of Directors

  SALT LAKE CITY, March 19, 2019 (GLOBE NEWSWIRE) — Predictive Technology Group, Inc. (OTC PINK: PRED), a leader in the use of data analytics for disease identification and subsequent therapeutic intervention through precision therapeutic treatments, announces the appointment of Senator Orrin G. Hatch and Ronald Barhorst to the company’s Board of Directors, effective immediately. Senator Hatch brings experience from his seven terms as a U.S. Senator including serving as a member and/or chair of various U.S. Senate committees. Mr. Barhorst brings 25 years of experience as a senior executive in the financial services industry and has served as an advisor to the company or its predecessors for nearly 10 years. These two appointments expand Predictive’s Board to six including four independent directors.

“We are pleased that Senator Orrin Hatch and Ronald Barhorst have chosen to join Predictive’s Board, bringing their wealth of experience and proven expertise in governance, regulatory, commercial, legal and financial matters,” said Bradley C. Robinson, CEO of Predictive Technology Group. “Their extensive backgrounds and experience are ideally suited for contributions to Predictive as we continue to mature and evolve as a publicly reporting company. We are honored that Senator Hatch and Mr. Barhorst have offered to generously share their time and expertise in support of our goal at Predictive of improving the quality of life of millions who may benefit from applying our novel precision medicine approach to underserved indications. We welcome them to our Board.”

“I’m excited to join Predictive and support its mission of delivering needed personalized care to millions of individuals through the commercialization of industry-leading breakthroughs in both genetics and cellular therapy,” said Senator Hatch. “Predictive’s approach to precision medicine holds the promise of offering tremendous relief to those suffering from chronic ailments and debilitating pain. I have witnessed the pain and suffering of endometriosis at a personal level as it has impacted my family. I look forward to working toward achieving the company’s goals.”

Senator Hatch is an attorney and retired politician who served as a U.S. Senator from Utah for 42 years. First elected in 1976, he was the longest-serving Republican U.S. Senator in history.  Senator Hatch served as either the chair or ranking minority member of the Senate Judiciary Committee from 1993 to 2005. He previously chaired the Senate Committee on Health, Education, Labor, and Pensions from 1981 to 1987. Senator Hatch also served as Chairman of the Senate Finance Committee. On January 3, 2015, after the 114th United States Congress was sworn in, Hatch became President pro tempore of the Senate. Senator Hatch retired from the U.S. Senate in 2019.

“Similar to Senator Hatch, my family has had personal experience with the chronic pain and suffering of endometriosis,” said Mr. Barhorst. “Having had the opportunity to work with Predictive or its predecessor companies for close to a decade, I am deeply committed to the company’s mission and team.  I’m accepting a position on Predictive’s board of directors to represent all stakeholders, including those suffering from diseases such as endometriosis.”

Mr. Barhorst is chair of The California State University Foundation. He is retired as president and chief executive officer of ING Financial Advisers, LLC and ING Investment Advisors, LLC and Systematized Benefits Administrators, Inc. He was also head of national accounts, healthcare and government markets. He previously served as director of residential services for Montgomery County Board of Mental Retardation and Development Disabilities and as treasurer for the Ohio Private Residential Services Association and Executive Director of Choices in Community Living, a non-profit organization he developed. Mr. Barhorst has served on numerous non-profit boards, including the California Business Roundtable for Education Excellence.

About Predictive Technology Group, Inc.

Predictive Technology Group aims to revolutionize patient care through predictive data analytics, novel gene-based diagnostics and companion therapeutics through its subsidiaries Predictive Therapeutics, Predictive Biotech, Predictive Diagnostics and Predictive Laboratories.  These subsidiaries are focused on endometriosis, scoliosis, degenerative disc disease and human cell and tissue products.  The subsidiaries use genetic and other information as cornerstones in the development of new diagnostics that assess a person’s risk of illness and therapeutic products designed to identify, prevent and treat diseases more effectively.  Additional information is available at Predtechgroup.com; Predrx.com and Predictivebiotech.com.

Forward-Looking Statements

To the extent any statements made in this release contain information that is not historical, these statements are essentially forward-looking and are subject to risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for human cell and tissue products and other pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials, availability of additional intellectual property rights, availability of future financing sources, the regulatory environment, and other risks the Company may identify from time to time in the future.