Predictive Therapeutics Press Release Archive

Predictive Technology Group Reports Second Quarter Fiscal 2020 Financial Results and Provides Corporate Update

SALT LAKE CITY (February 14, 2020) Predictive Technology Group (OTC PINK: PRED) (“Predictive” or “The Company”), a leader in helping identify barriers that impact women’s health and build healthier families through its innovations to deliver personalized medicine, today announced financial results for the fiscal second quarter ended December 31, 2019 and provided a corporate update.

Management Commentary

“During the fiscal second quarter and subsequent period, we made significant progress toward our goal of becoming a leading developer of diagnostics and therapeutics targeting the women’s health and fertility markets,” said Bradley C. Robinson, Chief Executive Officer of Predictive Technologies Group. “The clear highlight since our last quarterly report is the announcement last month that we entered into a broad molecular diagnostic oncology development collaboration with Atrin Pharmaceuticals to develop diagnostic tools to facilitate improved selection of cancer patients who would most benefit from treatment with Atrin’s DNA Damage and Response inhibitors and other small molecule ATR inhibitors. This first-of-its-kind collaboration opens significant new markets for our state-of-the-art sequencing capabilities, genomics expertise and companion diagnostics and, we believe, establishes a framework for additional collaborations in the future.”

“At the same time, market uptake for our recently introduced diagnostic tests, including FertilityDX™ and ARTguide™, is exceeding our expectations, reflecting the significant unmet needs that exist for accurate tests that can help patients and their doctors identify risk factors and barriers to pregnancy and develop tailored fertility treatments.”

“We did anticipate some softness in our Predictive Biotech business during the quarter, driven by heightened FDA regulation of human cell and tissue products, and the regenerative medicine industry as a whole, which we believe caused a contraction across the market and a year-over-year decline in our Predictive Biotech revenue. Total company revenue for the quarter was $7.3 million, down about $3.4 million from $10.7 million that was reported fiscal second quarter of 2018. Notwithstanding this temporary headwind, however, we see significant value in the Biotech business, and we are the clear industry leader with an excellent safety and quality record of over 100,000 allografts implanted with no adverse events.”     

Mr. Robinson concluded, “As we enter the back half of our fiscal year, we continue to execute on our growth plan, and we believe that our emergence as a women’s health leader, together with our anticipated up-listing to the Nasdaq exchange, will unlock significant long-term value for our shareholders.”

Fiscal Second Quarter and Recent Highlights

  • Announced positive interim beta test results on over 1,000 patients tested with ARTguide™ at Houston Fertility Institute. Initial test results exceed all expectations and parameters established during research and development and prospective data continue to accumulate regarding pregnancy rates and other treatment outcomes.
  • In January, announcement of a molecular diagnostic oncology development collaboration with Atrin Pharmaceuticals to develop diagnostic tools to facilitate improved selection of cancer patients who would most benefit from treatment with Atrin’s DNA Damage and Response inhibitors and other small molecule ATR inhibitors
  • In October, announced the successful U.S. launch of FertilityDX™, a comprehensive genetic testing service that identifies barriers to healthy pregnancy and birth, allowing doctors to tailor fertility treatments
  • Continued to work to satisfy Nasdaq listing requirements with the goal of up-listing PRED shares to the Nasdaq exchange

Fiscal Second Quarter 2020 Results

Revenues from operations (net) for the three months ended December 31, 2019 totaled $7.3 million, compared with $10.7 million for the three months ended December 31, 2018. The decrease of $3.4 million was primarily due to the decline in sales volume of allograft products as compared to the year-ago period. The decrease in sales volume is due to increased FDA enforcement efforts affecting the regenerative medicine industry as a whole, which has negatively impacted the size of the market for regenerative medicine services and caused a contraction of sales of allograft products. 

Cost of goods sold (“COGS”) for the three months ended December 31, 2019 was $5.8 million (or 79.6% of revenue) compared with $3.1 million (or 28.6% of revenue) for the three months ended December 31, 2018. The increase in COGS is primarily due to $1.9 million in scrap expense and idle capacity costs resulting from efforts to curtail production in response to the trend in allograft sales. In addition, there was a $0.8 million increase in scrap expense due to a decrease in average quality control pass rates for WIP product compared to the three months ended December 31, 2018.

Sales and marketing expenses for the three months ended December 31, 2019 were $3.0 million, compared with $3.4 million for the three months ended December 31, 2018. The decrease in sales and marketing expense was due to lower paid commissions, as a majority of the company’s sales and marketing expenses are incurred in the HCT/P segment.

Research and development (R&D) expenses for the three months ended December 31, 2019 were $2.4 million, compared with $1.8 million for the three months ended December 31, 2018, the increase was primarily related to the development of new allograft products and continued development of molecular diagnostic tests.

General and Administrative (G&A) expenses for the three months ended December 31, 2019 were $7.0 million compared with $2.9 million for the three months ended December 31, 2018.  Approximately $3.3 million of the increase is due to increased share-based compensation expenses. Personnel costs also increased by $0.6 million.

Amortization and depreciation expenses for the three months ended December 31, 2019 were $2.8 million, compared with $2.0 million for the three months ended December 31, 2018.  The increase was driven by growth in the company’s intangible asset portfolio arising from business combinations and asset acquisitions.

Other loss for the three months ended December 31, 2019 increased to $16.5 million from $0.6 million for the three months ended December 31, 2018. The increase was primarily driven by the recognition of an impairment charge of $15.9 million on our equity method investment in Juneau Biosciences, LLC as part of a broader impairment review triggered by the recent decline in the Company’s stock price.

The net loss attributable to controlling interest for the three months ended December 31, 2019 was $26.0 million, or $0.09 per share, versus a net loss attributable to controlling interest for the three months ended December 31, 2018 of $2.3 million, or $0.01 per share.

About Predictive Technology Group, Inc.

Predictive Technology Group aims to revolutionize and personalize precision patient care.  The Company’s entities harness predictive gene-based analytics to develop genetic and molecular diagnostic tests, as well as companion therapeutics, in order to support a patient from diagnosis through treatment. The Companies’ tests and products empower clinicians to provide their patients with the highest level of care.  Predictive’s subsidiaries include Predictive Laboratories, Predictive Biotech and Predictive Therapeutics.  For more information, visit www.predtechgroup.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.

Contacts: For more information, visit www.predtechgroup.com

Predictive Technology Group Announces Beta Test Results for its ARTguide™ Test

SALT LAKE CITY, Feb. 11, 2020 (GLOBE NEWSWIRE) — Predictive Technology Group (OTC PINK: PRED) (“Predictive” or “The Company”), a leader in helping identify barriers that impact women’s health and build healthier families through its innovations to deliver personalized medicine, today announced that its wholly owned subsidiary, Predictive Laboratories, received interim beta test results from its ARTguide™ test evaluating over 1,000 patients for risk of endometriosis at beta clinical sites. Initial test results have exceeded the Company’s expectations and parameters established during research and development. Prospective data continue to accumulate regarding pregnancy rates and other treatment outcomes, which will be shared in more detail later this year.

ARTguide™ is a non-invasive test that combines DNA marker genotypes with clinical predictors in a validated algorithm, which indicates a woman’s personal risk for endometriosis. The ARTguide™ test also assesses dozens of mutations in 12 established fertility genes to help optimize advanced fertility care.  

“We are pleased with the findings from the ARTguide™ beta test results. ARTguide™ provides physicians with clinically useful information helping guide women’s care,” said Dr. Kenneth Ward, M.D., laboratory director of Predictive Laboratories. “For patients seeking advanced infertility treatment, we believe that this test will offer meaningful insight into therapy best suited to lead to a successful pregnancy.”

Dr. Gassan Haddad, medical director at Houston Fertility Institute, added, “We are excited to be collaborating with Predictive Laboratories in beta testing of ARTguide™ and are happy to have surpassed over 1,000 patient results. Houston Fertility Institute is also participating in an IRB approved ARTguide™ retrospective study (patients with known ART outcomes) to be published later this year.”

Bradley Robinson, president and chief executive officer of Predictive Technology Group, added, “Completing over 1,000 patient tests is an important milestone towards the validation and commercialization of ARTguide™. To be able to provide a better understanding of fertility barriers and a course of action for overcoming those barriers to women and their families who are struggling is a real game-changer and long over-due. We are happy with the beta test results so far indicating that ARTguide™ is a powerful tool for optimizing advanced fertility care.”

Most female infertility can be treated with existing medications or surgery; however, the optimal treatment of infertility may be different if a physician knows that a woman has endometriosis or another genetic disorder. More than 50 percent of infertile women have endometriosis according to several studies. In the past, most women had a laparoscopy before being treated with ART. Today most women never get a definitive surgical procedure to diagnose endometriosis because of improved ART treatments, and because of the cost and surgical risks associated with laparoscopy.

About Endometriosis
Endometriosis is found in 50 percent or more of infertile women.  Endometriosis is characterized by an abnormal growth of the tissue that normally lines the inside of the uterus (endometrium) outside of the uterus – usually in the pelvis and abdomen, but also in distal sites (e.g. lung, heart, brain).  It is a complicated and painful disorder that dramatically affects women’s lives.  From diminished quality of life and increased incidence of depression, to adverse effects on intimate relationships and limitations in participation in daily activities, it impacts women at home, at work and at play. Endometriosis is poorly predicted by symptoms. Many infertility patients with endometriosis have no symptoms.  As a result, the diagnosis is not made. And it is not treated. Importantly, because the evaluation of unexplained infertility no longer includes a mandatory laparoscopy, many women (58% in some studies) do not have their endometriosis diagnosis made. Thus, they may undergo unnecessary treatments, or they may respond less favorably to standard infertility treatments.  Indeed, many have failed 3 or more IVF cycles. Hormonal suppression and laparoscopic treatment of minimal or mild endometriosis improves pregnancy rates regardless of the treatment modality or the follow-up care.

About Predictive Laboratories, Inc.

Predictive Laboratories’ discoveries in molecular and genetic diagnostics focus on unmet needs in women’s health, infertility and other diseases. Predictive Laboratories offers earlier detection of disease through genetic assessment to guide personalized precision medicine. Leveraging its vast genetic database, Predictive Laboratories enables the discovery of genes and gene mutations that identify hard-to-diagnose and detect diseases and their prognosis.

The Company’s proprietary tests include ARTguideTM and FertilityDXTM. ARTguideTM is a blood test that assesses a woman’s endometriosis risk and 12 other well defined genetic causes of infertility in order to optimally navigate the path towards conception. FertilityDXTM is a comprehensive test and service, using the parental genetic assessment as the map to guide the journey to successful pregnancy and a healthy newborn. Predictive Laboratories’ tests are processed at the Company’s state-of-the-art CAP-accredited, CLIA-certified laboratory, equipping physicians with the robust diagnostic tools to provide personalized treatment for their patients. For more information, visit www.predictivelabs.com.

About Predictive Technology Group, Inc.

Predictive Technology Group aims to revolutionize and personalize precision patient care.  The Company’s entities harness predictive gene-based analytics to develop genetic and molecular diagnostic tests, as well as companion therapeutics, in order to support a patient from diagnosis through treatment. The Companies’ tests and products empower clinicians to provide their patients with the highest level of care.  Predictive’s subsidiaries include Predictive Laboratories, Predictive Biotech and Predictive Therapeutics.  For more information, visit www.predtechgroup.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.

Contacts

For more information, visit www.predtechgroup.com

Predictive Technology Group and Atrin Pharmaceuticals Announce Molecular Diagnostic Oncology Development Collaboration

SALT LAKE CITY- January 28, 2020- Predictive Technology Group (OTC PINK: PRED) and Atrin Pharmaceuticals LLC are entering into a collaboration agreement to develop molecular diagnostic tools to facilitate improved selection of cancer patients who would most benefit from treatment with DNA Damage and Response (DDR) inhibitors, including Atrin’s and other small molecule ATR inhibitors. Atrin and Predictive will jointly utilize Predictive Laboratories’ state-of-the-art sequencing capabilities and genomics expertise to identify cancer patients with specific molecular markers that predict the level of clinical response to Atrin’s, and other, targeted therapies. This is intended to improve patient outcomes as well as improve Atrin’s ability to successfully progress its product pipeline, and upon commercialization, improve on the treatments for women with cancer.

“We are very pleased to work with Atrin Pharmaceuticals, a recognized leader in the development of anti-cancer therapeutics targeting DDR,” said Bradley Robinson, president and chief executive officer of Predictive Technology Group. “We see an opportunity to develop a precision medicine approach to address unmet medical needs by combining our state-of-the-art sequencing capabilities, genomics expertise and companion diagnostics with Atrin’s targeted therapeutics. This collaboration is consistent with our vision of building a leading women’s health platform, and we look forward to working together on this important initiative.”

Oren Gilad, Ph.D., president and chief executive officer of Atrin Pharmaceuticals, noted: “Following a successful due diligence process, we concluded that Predictive, with its proprietary list of already identified genes and state-of-the-art sequencing capabilities, is the ideal molecular diagnostic partner to help us successfully advance our therapeutic pipeline through clinical development. We believe that this collaboration may become a ‘game changer’ in oncology, as treatment continues to progress towards individualized precision medicine. As we advance multiple Investigational New Drug (IND) applications and progress our lead product candidate ATRN-119 into a first-in-human clinical study this year, Predictive’s portfolio of genomic tests will help us better identify cancer patient populations whose genetic profiles will likely have an optimal clinical response to our proprietary anti-cancer therapeutics.”

The collaboration will help optimize the safety and clinical efficacy of Atrin’s targeted cancer therapeutics and other DDR drug candidates. Atrin will have access to Predictive’s proprietary GenDB databases and women’s health biobank to better understand the clinical spectrum of germline mutations in DDR pathways. The companies will also study common gynecologic disorders, such as endometriosis, associated with the development of cancers in affected patients. The goal of this collaboration is to develop actionable predictive molecular and companion diagnostics and therapeutics for these common disorders and related cancers.

CLSA Capital Markets Limited, a CITIC Securities Company, under its mandate with Predictive Technology Group, will continue to introduce potential strategic partners and provide relevant regulatory guidance to Predictive Technology Group.

About DNA Damage and Response (DDR)

Cells are continuously exposed to endogenous and exogenous stress that can lead to DNA damage.  To counter this lethal threat, cells have several mechanisms to detect DNA damage, activate the appropriate repair pathway or, if irreparable, induce cell cycle arrest or apoptosis. These DDR processes are vital for cell survival. Many human diseases, including cancer, and cancer-predisposition syndromes, have been linked to mutations in DDR genes.

About Atrin Pharmaceuticals

Atrin Pharmaceuticals is a private biotech company focused on discovering and developing proprietary therapeutics targeting inhibition of DNA Damage and Response (DDR) proteins for first-line treatment of cancers. Atrin’s technologies and DDR product pipeline represent a new drug development approach for treating solid and other cancers that currently have limited or ineffective therapies by targeting inhibition of specific proteins that are active in cancer cells and relatively inactive in healthy tissue. For more information, visit www.atrinpharma.com.

About Predictive Technology Group, Inc.

Predictive Technology Group aims to revolutionize and personalize precision patient care.  The Company and its affiliates harness gene-based analytics to develop genetic and molecular diagnostic tests, as well as companion therapeutics, in order to support a patient from diagnosis through treatment. Predictive’s tests and products enable clinicians to provide their patients with the highest level of care.  Predictive’s subsidiaries include Predictive Laboratories, Predictive Biotech and Predictive Therapeutics.  For more information, visit www.predtechgroup.com.

About CLSA

CLSA is Asia’s leading capital markets and investment group, providing global investors with insights, liquidity and capital to drive their investment strategies. Award-winning research, an extensive Asia footprint, direct links to China and highly experienced finance professionals differentiate our innovative products and services in asset management, corporate finance, capital and debt markets, securities and wealth management. As the international platform of CITIC Securities (SSE: 600030, SEHK: 6030), China’s largest investment bank, CLSA is uniquely positioned to facilitate cross-border capital flows and connect China with the world and the world to China. Founded in 1986 and headquartered in Hong Kong, CLSA’s global network spans 20 locations across Asia, Australia, Europe and the United States. For more information, visit www.clsa.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.

Contacts: For more information, visit www.predtechgroup.com