Predictive Submits Emergency Use Authorization Application for Treatment of Acute Respiratory Distress Syndrome Secondary to COVID -19 with Umbilical Cord Mesenchymal Stem Cells

SALT LAKE CITY, April 13, 2020 (GLOBE NEWSWIRE) – Predictive Biotech, a wholly owned subsidiary of Predictive Technology Group (OTC PINK: PRED) (“Predictive” or “The Company”), announced that on April 9th it submitted an Emergency Use Authorization (EUA) application with the U.S. Food and Drug Administration (FDA) for the immediate use of mesenchymal stem cells (MSCs) derived from umbilical cord tissue for the treatment of Acute Respiratory Distress Syndrome (ARDS), secondary to SARS-CoV-2, coronavirus disease 2019 (COVID-19).

The pandemic caused by COVID-19 has shown to develop into severe ARDS in 30% of hospitalized patients with a 22%-62% mortality rate (Murthy et al., 2020) for those requiring hospitalization in an intensive care unit. Currently, there is no confirmed treatment that can demonstrate safety or efficacy for the treatment of COVID-19.

“Coronavirus can be deadly, in large part because the virus can cause ‘cytokine storms’ in which the patient’s own immune system triggers a runaway response causing more damage to the patient, than to the virus it’s trying to eliminate” said John Sorrentino, Chairman of Predictive Technology Group.  “Respiratory distress kills hundreds of thousands of people each year worldwide. There is clinical data from early clinical trials that seem to indicate that the avoidance of the cytokine storm utilizing MSCs may be a critical component for the treatment of COVID-19 infected patients.”

A recent review article published in Pain Physician, concluded that, “The limited but emerging evidence regarding UC MSC [umbilical cord mesenchymal stem cells] in managing COVID-19 suggests that it might be considered for compassionate use in critically ill patients to reduce morbidity and mortality in the United States.”

The proposed IND clinical trial will utilize Predictive’s proprietary core technology of naturally occurring MSCs derived from umbilical cord tissue (UC-MSCs) to assess the efficacy as an add-on therapy to standard treatment of patients with severe Acute Respiratory Distress Syndrome (ARDS) secondary to COVID-19.

Predictive’s UC MSC product, CoreCyteTM,

has already been used as an allograft in over 50,000 patients.  Physicians have reported to Predictive that over 1,100 patients have been treated with CoreCyte via intravenous administration. No serious adverse events have been reported with CoreCyte regardless of the route of administration. If Predictive’s EUA request is approved, CoreCyte would be available immediately to critically ill patients with ARDS due to COVID-19 infections.  

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 and companion therapeutics in order to support a patient from diagnosis through treatment.

Dedicated to identifying the barriers that impact lifelong health through our genetic library, genomic mapping and individualized diagnostics, Predictive’s tests and products empower clinicians to provide their patients with the highest level of care. For more information, visit www.predtechgroup.com.

About Predictive Biotech, Inc.

Predictive Biotech is a leader in regenerative medicine, its products are derived from tissue sources rich in properties that support the body’s natural ability to heal itself. All products are safely, ethically and minimally processed to deliver allografts that preserve the naturally occurring characteristics and factors of the donor tissue. Predictive’s signature products are uniquely born from the Wharton’s jelly layer of the umbilical cord and amniotic fluid and tissue.With over 100,000 units delivered, product safety and consistency has been realized by thousands of practices throughout the United States. A national network of clinics, health systems, researchers and physicians leverage Predictive’s four proprietary products: AmnioCyte™, AmnioCyte Plus™, PolyCyte™, and CoreCyte™.

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. These forward-looking statements are based on the current plans and expectations of management and are subject to a number of uncertainties and risks that could significantly affect The Company’s current plans and expectations, as well as future results of operations and financial condition. A more extensive listing of risks and factors that may affect The Company’s business prospects and cause actual results to differ materially from those described in the forward-looking statements can be found in the reports and other documents filed by The Company with the Securities and Exchange Commission. The company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts:

Predictive Biotech

Info@predictivebiotech.com

888-407-9761

Predictive Technology Group Announces Initial Order of One Million Units of the Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test from Distribution Partner, Wellgistics, LLC.

SALT LAKE CITY, April 8, 2020 (GLOBE NEWSWIRE) – Predictive Laboratories, a wholly owned subsidiary of Predictive Technology Group (OTC PINK: PRED) (“Predictive” or “The Company”), today shared that its distribution partner, Wellgistics, has submitted an initial order for immediate delivery of one (1) million units of the Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test(Assurance AB)intended for use by laboratories and healthcare workers at the point-of-care in the U.S.

“We have been working diligently with Wellgistics to get this first order put in motion, even prior to making our partnership announcement on April 3,” said Bradley Robinson, CEO of Predictive Technology Group. “This country is in high need of the Assurance AB testing for point of care use and we have brought all resources to bear to bring this product to the United States. Wellgistics has provided us with state-by-state demand guidance, to ensure that regions with the most urgent need have first access to the test. Our main priorities will be to focus on servicing those areas,” Robinson continued.

“When our partnership with Predictive was announced last week, our team was very aware of the coming tsunami wave of interest for this test,” said Brian Norton, CEO of Wellgistics. “This demand grows each day as more attention hits the media and is recognized as a viable solution toward identifying immunity and allowing people to go back to work. Presently, the Wellgistics team is hyper focused on closing the final gaps of the complex web of international logistics. We feel great about where we are, and we will provide new updates as quickly as they are available.”

Predictive announced website updates relating to Assurance AB including:

Instructions For Use, Quick Reference Guide and Fact Sheet for laboratories and healthcare workers at the point-of-care. The website also includes an instructional video on administering the Assurance AB test. 

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 and companion therapeutics in order to support a patient from diagnosis through treatment.

Dedicated to identifying the barriers that impact lifelong health through our genetic library, genomic mapping and individualized diagnostics, Predictive’s tests and products empower clinicians to provide their patients with the highest level of care. For more information, visit www.predtechgroup.com.

About Predictive Laboratories, Inc.

Predictive Laboratories’ molecular and genetic diagnostics focus on hard-to-diagnose and hard-to-detect diseases. Leveraging its vast genetic library, Predictive offers earlier detection of a variety of diseases through genetic assessments to guide personalized precision medicine.

Equipped with a state-of-the-art CAP and CLIA accredited laboratory, Predictive operations perform next-generation sequencing experiments, including whole exome sequencing, gene and genetic marker panels, and low-pass whole genome analysis of embryos for aneuploidies. Predictive arms physicians with the most robust diagnostic tools to provide personalized precision treatment for their patients. For more information, visit www.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. These forward-looking statements are based on the current plans and expectations of management and are subject to a number of uncertainties and risks that could significantly affect the company’s current plans and expectations, as well as future results of operations and financial condition. A more extensive listing of risks and factors that may affect the company’s business prospects and cause actual results to differ materially from those described in the forward-looking statements can be found in the reports and other documents filed by the company with the Securities and Exchange Commission. The company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts:

Predictive Laboratories

Info@predictivelabs.com

855-497-3636

Predictive Technology Group Announces Distribution Agreement with Wellgistics, LLC for Its Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test for Use by Laboratories and Healthcare Workers at the Point-of-Care

SALT LAKE CITY, April 2, 2020 — Predictive Technology Group (OTC PINK: PRED) (“Predictive” or “The Company”), a leader in the development of genetic and molecular diagnostics and companion therapeutics, today announced a distribution agreement between its subsidiary, Predictive Laboratories and Wellgistics, LLC of Lakeland, Florida for distribution in the U.S. of its Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test (Assurance AB) intended for use by laboratories and healthcare workers at the point-of-care in the U.S.

Wellgistics, LLC, is one of the fastest growing wholesale pharmaceutical distributors in the United States. It is a logistics leader in the complex healthcare supply chain. Wellgistics is licensed in all 50 states as a Pharmaceutical Wholesale Distributor and is also licensed or permitted as Third-Party Logistics provider in all states. Its distribution facility, located in Lakeland, FL, is VAWD- accredited by the National Association of Boards of Pharmacy.

“From the onset of this global crisis, the Wellgistics’ leadership team has placed its sole focus on finding solutions for America.  We felt confident that our competency in healthcare and pharmaceutical distribution would be sought out by product innovators to assist in delivering critically needed supplies throughout the country.” Said Brian Norton, CEO of Wellgistics.

“Our newly established alliance with Predictive Laboratories allows us to leverage our complex distribution network in delivering the life-saving Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test to healthcare professionals all across the country. We are keenly aware and very impressed with the extensive steps taken by Predictive to ensure the highest levels of quality in their dual channel IgM/IgG product, which we believe will become the “gold standard” in the marketplace,” said Norton.

“We are pleased to partner with Wellgistics. They are an ideal partner and are able to scale and serve the most critical needs in the face of this global pandemic. Wellgistics’ logistics, expertise and infrastructure has demonstrated the ability to efficiently move products from around the world to the U.S. market and was an important component in our decision to partner with them. We are in production in advance of Wellgistic’s purchase orders and will update stakeholders on details over the next few days,” said Bradley Robinson, CEO of Predictive Technology Group. “We will support Wellgistics, their team and customers with Predictive Laboratories’ full scientific, operational and service team members,” added Robinson.

About the Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test:

The Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test is a rapid test for the qualitative detection of IgM and IgG antibodies associated with the SARS-CoV-2 virus. Assurance AB is a single-use, self-contained test that provides results in 15 minutes, helping authorities, employers and healthcare workers make informed decisions to contain the spread of COVID-19.

Assurance AB is intended for individuals who display signs and symptoms of COVID-19, individuals who were exposed to someone infected with COVID-19, or individuals who want qualitative information about whether or not they have IgM or IgG antibodies. Assurance AB is for use by laboratories and healthcare workers at the point-of-care.

What is antibody testing?

Antibody assays have the ability to detect past infections and indicate probable immunity. Antibodies are long-lasting and may be detected in the bloodstream several years after infection. 

Assurance AB detects the presence of antibodies IgM and IgG, developed in response to the SARS-CoV-2 virus. The antibody and its relative levels may be used to indicate the stage of infection and estimate time since exposure to the virus for contact tracing.

  • IgM: develop EARLY after SARS-CoV-2 virus exposure
  • IgG: develop LATER after SARS-CoV-2 virus exposure; indicates long-term immunity

Assurance AB Benefits

  • Results in 15 minutes
  • Highly accurate (92% sensitivity (CI95% 89.4-95.7%); 100% specificity (CI95% 96.8-100%))
  • NO laboratory equipment required
  • NO specialized training required, easy-to-use
  • Reduces risk of spreading the virus to healthcare workers administering tests or technicians processing tests
  • Provides actionable information to all patients to help determine if a COVID-19 viral PCR test is needed
  • Provides insightful information for when it is safe for individuals to go back to work and resume normal activities of daily life
  • Test kits can be stored and used at room temperature
  • Antibody testing is improved over nasopharyngeal swab testing by the fact that antibodies are more uniformly present in blood sampling

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 and companion therapeutics in order to support a patient from diagnosis through treatment.

Dedicated to identifying the barriers that impact lifelong health through our genetic library, genomic mapping and individualized diagnostics, Predictive’s tests and products empower clinicians to provide their patients with the highest level of care.  For more information, visit https://predtechgroup.com/

About Predictive Laboratories, Inc.

Predictive Laboratories’ molecular and genetic diagnostics focus on hard-to-diagnose and hard-to-detect diseases. Leveraging its vast genetic library, Predictive offers earlier detection of a variety of diseases through genetic assessments to guide personalized precision medicine.

Equipped with a state-of-the-art CAP and CLIA accredited laboratory, Predictive operations perform next-generation sequencing experiments, including whole exome sequencing, gene and genetic marker panels, and low-pass whole genome analysis of embryos for aneuploidies. Predictive arms physicians with the most robust diagnostic tools to provide personalized precision treatment for their patients. For more information, visit www.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. These forward-looking statements are based on the current plans and expectations of management and are subject to a number of uncertainties and risks that could significantly affect the company’s current plans and expectations, as well as future results of operations and financial condition. A more extensive listing of risks and factors that may affect the company’s business prospects and cause actual results to differ materially from those described in the forward-looking statements can be found in the reports and other documents filed by the company with the Securities and Exchange Commission. The company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts:

Predictive Laboratories

Info@predictivelabs.com

855-497-3636

Predictive Technology Group and Manufacturing Partners Provide Updates of Its Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test for Use by Laboratories and Healthcare Workers at the Point of Care

Company provides formal response to misleading recently published short report

SALT LAKE CITY, March 30, 2020 — Predictive Technology Group (OTC PINK: PRED) (“Predictive” or “The Company”), a leader in the development of genetic and molecular diagnostics and companion therapeutics, and its manufacturing partner, Jiangsu Dablood Pharmaceutical CO, Ltd. (Dablood), a partner entity of Da An Gene Co., Ltd., today made several updates and progress reports on its Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test(Assurance AB)intended for laboratories and healthcare workers at the point-of-care in the U.S.   

“An opinion piece critical of Predictive was posted online last week by individually unidentified author(s) who admitted they have taken a short position in shares of The Company,” said John Sorrentino, chairman of Predictive Technology Group. “We encourage every reader to do their own due diligence and review the documents posted today on Predictive Laboratories’ website. The author(s), hiding behind anonymity – and attempts to disclaim – also warn that ‘Hindenburg Research makes no representation, express or implied, as to the accuracy, timeliness, or completeness of any such information.’ Because the opinion piece itself warns readers of its short position-based bias and its unwillingness to guarantee the accuracy of any ‘information’ it espouses, The Company will not dignify the opinion piece with a point-by-point response, however we felt compelled to address a few egregious misrepresentations and untruths.”

The opinion piece asserts a material falsehood that “Dablood is NOT one of the companies approved by the Chinese government to offer COVID-19 tests. The official list of approved COVID-19 test providers is published by the Chinese government, was updated as of March 17th, and does not include Dablood or its affiliates.” If properly investigated, one can find that #5 on the referenced list is Da An Gene Co., Ltd. Guangzhou Darui Biotechnology, a subsidiary of Da An Gene Co., Ltd., has joint venture entity in Dablood. As such, Dablood operates under the Da An Gene Co., Ltd. license.

Regarding Predictive’s formal request for Emergency Use Authorization (EUA) from the FDA to distribute Assurance AB, the opinion piece states, in part, that “Predictive has no specific approval from requisite U.S. authorities to provide this test.” The Company views this statement as simply not true. 

“The FDA’s recent guidance on COVID-19 antibody (i.e. serological) diagnostic tests clearly allows manufacturers to market these tests in the United States to laboratories and healthcare workers at the point of care, so long as the tests have been validated and notification is provided to the FDA,” said Bradley Robinson, CEO of Predictive Technology Group. “The Predictive/Dablood test meets these criteria. Additionally, The Company has formally submitted an EUA with the FDA. If granted, this would provide Predictive the ability to market the test for in-home use.”

Predictive Laboratories, Inc., a wholly-owned entity of The Company, operates a CLIA-certified and CAP-accredited laboratory which is responsible for the distribution of the Assurance AB.Predictive Laboratories has updated its website to include the following:

  • Dablood Board of Directors response to the erroneous and misleading Hindenburg opinion piece published on March 27, 2020
  • FDA confirmation receipt of EUA application
  • Representative of Foreign Manufacturer Notice from Dablood to the FDA
  • Manufacturer FDA EUA Notification from Dablood to the FDA
  • U.S. Agent Retainer Agreement

“The Hindenburg piece repeatedly and inaccurately attempts to cast Predictive solely as a stem cell company while ignoring The Company’s other diagnostic assets, such as ARTguideTM and FertilityDXTM, and its recently announced diagnostic assay collaboration with Atrin Pharmaceuticals. In this context, a COVID-19 rapid antibody test is a logical addition to Predictive’s portfolio. Nevertheless, they attempt to cast Predictive as simply a stem cell company,” said Robinson. “Predictive encourages thoughtful investors to consider the motives of these anonymous authors when assessing the truthfulness and accuracy of any statement or report in the opinion piece. Predictive will pursue any and all legal actions against individuals and entities who intentionally mislead Predictive stakeholders.”

“The response to the announcement of Assurance AB (March 25, 2020) has been very strong,” continued Robinson. “In particular, both international and domestic governmental agencies have expressed strong interest in how rapid antibody testing can help with the public health response to this critical pandemic. We want to acknowledge the tireless activities by our employees and partners in developing a tool that can be a part of solving this global health crisis.”

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 https://predtechgroup.com.

About Predictive Laboratories, Inc.

Predictive Laboratories a wholly owned molecular and genetic diagnostics company of Predictive Technology Group (OTC Pink: PRED) is focused on hard-to-detect diseases. The laboratory is equipped with state-of-the-art equipment for any next-generation sequencing experiments including whole exome sequencing, gene and genetic marker panels, and low-pass whole genome analysis of embryos for aneuploidies – www.predtechlabs.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. These forward-looking statements are based on the current plans and expectations of management and are subject to a number of uncertainties and risks that could significantly affect the company’s current plans and expectations, as well as future results of operations and financial condition. A more extensive listing of risks and factors that may affect the company’s business prospects and cause actual results to differ materially from those described in the forward-looking statements can be found in the reports and other documents filed by the company with the Securities and Exchange Commission. The company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

www.predictivelabs.com

Contacts:

Predictive Laboratories

institutional@predictivelabs.com

commercial@predictivelabs.com

info@predictivelabs.com

855-497-3636

Predictive Technology Group Announces Launch of Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test for Use by Laboratories and Healthcare Workers at the Point of Care

Assurance AB™ is a single-use, self-contained SARS-CoV-2 (COVID-19) antibody detection test that provides results in 15-minutes

SALT LAKE CITY, March 25, 2020 — Predictive Technology Group (OTC PINK: PRED) (“Predictive” or “The Company”), a leader in the development of genetic and molecular diagnostics and companion therapeutics today announced that in response to the demand for high volume test availability for the SARS-CoV-2 (COVID-19) global pandemic, Predictive Laboratories, a wholly-owned subsidiary of The Company has notified the U.S. Food and Drug Administration of its intent to immediately distribute the validated Assurance AB™ COVID-19 IgM/IgG Rapid Antibody Test (Assurance AB) test to laboratories and healthcare workers at the point-of-care in the U.S.  

The Assurance AB test was developed to detect the presence of IgM and/or IgG antibodies to the SARS-CoV-2 virus. The test requires only a fingerstick to sample an individual’s blood which is then placed on the self-contained test device. The test takes 15-minutes to display results. The test results indicate the presence of antibodies associated with the SARS-CoV-2 virus.

“Our company is committed to help with the global challenge of testing for the COVID-19 virus.” said Bradley Robinson, CEO of Predictive Technology Group. “Testing strategies for the pandemic are fluid and changing daily. We have worked diligently with our partners who have experience in testing tens of millions of patients worldwide. We appreciate their assistance in allocating resources and transferring vital knowledge for identifying individuals that have had an immune reaction and developed antibodies in response to virus exposure. Domestic and international governmental agencies, healthcare groups, pharmacies and employers have shown a strong interest in our test,” added Robinson. The Company will distribute the Assurance AB test through its wholly-owned subsidiary Predictive Laboratories, Inc., a CLIA certified and CAP accredited laboratory.

John Nelson M.D. former president of the American Medical Association and Predictive scientific advisory board member commented “The overwhelming need for a quick and accurate test for this pandemic is obvious. Focusing on an antibody test helps accelerate results and protect healthcare workers. The Assurance AB test is a valuable tool for truly understanding the spread of COVID-19 in the U.S.”

Assurance AB can help authorities, employers and healthcare workers make informed decisions on whether or not to continue precautions. Point of care serology testing may allow individuals with antibodies the confidence to go back to the workplace and engage in their communities.

Additional advantages of the Assurance AB test include:

  • inexpensive test with results in 15 minutes
  • antibody testing is less complex and remedies potential false negative results common in nasopharyngeal swab sampling
  • sample collection type (blood droplets) nearly eliminates the risk of spreading the virus to healthcare workers administering tests and/or to laboratory personnel who handle the submitted samples

Because of the rapid spread of the COVID-19 virus, several states including California and New York have recently expressed immediate need for rapid antibody testing. While there are benefits to viral testing, serology antibody testing allows patients to know if they have been exposed to the virus and if they have developed antibodies typically associated with immunity.

Assurance AB COVID-19 IgM/IgG Rapid Antibody Test is being manufactured in cooperation with Jiangsu Dablood Pharmaceutical CO, Ltd. Dablood Pharmaceutical has successfully distributed 38 million tests to date throughout Asia and Europe. To the best of Predictive’s knowledge, Dablood Pharmaceutical is one of very few companies approved by the Chinese government to co-develop and manufacture rapid antibody tests. Dablood Pharmaceutical is one of the largest diagnostic kit manufacturers in China and is currently producing up to 1.5 million units of the rapid antibody test per day in China. Predictive evaluated other potential developers and suppliers and believes Dablood Pharmaceutical provides not only existing inventory, its high-volume production capacity enables them to rapidly increase production to provide high-quality tests to meet rapidly expanding global demand. Dablood Pharmaceutical has been recognized by the Chinese government for its effort of developing and producing testing products to help the detect the COVID-19 and has received approval for distribution of its test across the domestic Chinese market and the European Union with a CE mark.

Predictive is also pursuing procurement authorization through the Biomedical Advance Research and Development Authority (BARDA) under the Office of the Assistant Secretary for Preparedness and Response (ASPR) in Health and Human Services (HHS). The Company cautions that if the federal government decides to restrict adequate reimbursement or the foreign import of products manufactured in Asia, the Company will not be able to provide access to these tests in the U.S.

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.

About Predictive Laboratories, Inc.

Predictive Laboratories a wholly owned molecular and genetic diagnostics company of Predictive Technology Group (OTC Pink: PRED) is focused on hard-to-detect diseases. The laboratory is equipped with state-of-the-art equipment for any next-generation sequencing experiments including whole exome sequencing, gene and genetic marker panels, and low-pass whole genome analysis of embryos for aneuploidies.

www.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. These forward-looking statements are based on the current plans and expectations of management and are subject to a number of uncertainties and risks that could significantly affect the company’s current plans and expectations, as well as future results of operations and financial condition. A more extensive listing of risks and factors that may affect the company’s business prospects and cause actual results to differ materially from those described in the forward-looking statements can be found in the reports and other documents filed by the company with the Securities and Exchange Commission. The company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts:

Predictive Laboratories
institutional@predictivelabs.com
commercial@predictivelabs.com
info@predictivelabs.com
855-497-3636

Predictive Technology Group Addresses Use of Mesenchymal Stem Cells in Treatment of Secondary Issues Related to Coronavirus

SALT LAKE CITY, March 17, 2020 (GLOBE NEWSWIRE) — Predictive Technology Group (OTC PINK: PRED) (“Predictive” or “The Company”), today announced that last week it began communication with domestic and international agencies and groups to be a supplier of mesenchymal stem cells (MSCs) for the potential clinical treatment of patients suffering from secondary issues related to the coronavirus (COVID-19). In other related news today the American Society of Interventional Pain Physicians (ASIPP) issued a statement on COVID-19, discussing practices and urging authorities to approve expanded umbilical cord stem cell infusions as a treatment. WWW.asipp.org/asipp-updates/STATEMENT-FROM-ASIPP-ON-COVID-19

ChinaXiv recently reported (March 2, 2020) the outcomes of seven patients with COVID-19 pneumonia enrolled in a clinical trial at Beijing YouAn Hospital, China. The clinical outcomes, as well as changes in inflammatory and immune function levels, and adverse effects of the enrolled patients were assessed over the 14 days following MSC injection. The patients were treated with MSCs derived from the Wharton’s jelly layer of the umbilical cord. The pulmonary function and symptoms of all seven patients with COVID-19 pneumonia were significantly improved within 2 days of the MSC transplantation.

Utilizing regenerative medicine technology with the administration of MSCs may help mitigate underlying COVID-19 associated lung damage. While this treatment is not a method to vaccinate nor cure the virus, the results reported in this publication indicate that infected patients may be more likely to combat and survive the related secondary issues of a COVID-19 infection if regenerative technologies are applied.

“Given our expertise and proprietary processes for isolating the MSC’s from source tissue, combined with our strong safety record in delivering tens of thousands of allografts to the market, it is not surprising that we have received a high number of inquiries regarding our potential involvement with this global health crisis,” said Bradley Robinson, CEO of Predictive Technology Group. “We are watching the development of clinical trials from around the world and remain poised to help in any we can, pending regulatory guidance. Our experience and capital investments over the past few years has equipped us with the expertise and ability to scale to meet demand,” added Robinson.

MSCs have the ability to differentiate into a variety of cell types and are able to resist viral attacks with the expression of interferon gamma stimulated genes (ISGs). With the ability to express ISGs, stem cells would be expected to survive even when transplanted into a patient with an active COVID-19 infection. Stem cells rejuvenate and regenerate cells in the body through various processes involving reduction of inflammation, secretion of substances that protect cells, transfer of mitochondria, reduction of cell death, anti-oxidative effects and improvement of immune system function. These effects are likely to increase survival in patients infected with COVID-19.

Additionally, there is evidence of stem cells aiding in the protection against viral infection. The influenza virus A/H5N1 is known to cause acute lung injury. With the injection of human MSCs, A/H5N1 was reduced in mice and the treatment increased rates of survival (Chan, et al, PNAS 113:3621, 2016).

Umbilical cord tissue is particularly rich in MSCs, which is why many parents choose to store them. As new clinical therapies are discovered, the importance of storing stem cells from perinatal tissue (umbilical cord and placenta) will become a critical source for individuals needing stem cell therapies in the future. 

Predictive Technology Group was the first to market and is the current market leader in the United States for the procurement and processing of umbilical cord tissue for clinical use. Predictive has operated its FDA-compliant commercial biologics manufacturing facility for several years. This facility is cGMP and cGTP compliant, ISO13485 certified, and FDA registered. All clinical manufacturing occurs in an ISO 7 certified sterile cleanroom with extensive and advanced testing to assure the absence of contamination.

“We are well positioned to have the procurement, processing and cell culturing expertise and scale to offer stem cell therapy for secondary issues related to COVID-19 infections in both domestic and international markets. While effective vaccines are being developed, US-based stem cell transplants represent a real opportunity to fight the virus and increase survival rates with patients infected worldwide,” Bradley Robinson added.

As the major commercial supplier of umbilical cord MSCs in the United States, Predictive is well positioned to continue its leadership role in ensuring a stable supply of this potentially life-saving intervention that has been associated with promoting the regeneration and repair of lung tissue damaged by acute respiratory viral infections, such as those caused by COVID-19. The company plans to evaluate potential research and commercial collaboration opportunities to supply stem cells either directly through Predictive, or in collaboration with other private and/or public entities.

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

Atrin Pharmaceuticals Adds Critical Genomics Capabilities in Advance of Initiating First Clinical Trial Through Ongoing Collaboration with Predictive Technology Group

Doylestown, PA – February 25, 2020 – Atrin Pharmaceuticals, a private biopharmaceutical company pioneering the discovery and development of proprietary molecules targeting DNA Damage and Repair (DDR) pathways to treat cancers that currently do not have effective therapies, today reported preliminary results from a collaborative genomics analysis that will be used to optimize patient selection for Atrin’s upcoming ATRN-119 clinical trial.  This genomics analysis was a result of Atrin’s collaboration with Predictive Technology Group to utilize next-generation genomics capabilities to improve predictive selection of clinical study patients most likely to respond and least likely to experience side effects from treatment with Atrin’s DDR drug candidates. 

Atrin and Predictive have been jointly developing proprietary approaches to better identify patients with specific mutations that drive cancer tumor growth, regardless of tumor type, and who are most likely to clinically respond to synthetically-lethal anti-cancer therapies. Predictive’s genomics capabilities were added to Atrin’s existing proprietary proteomic and medicinal chemistry technologies to improve targeting of DDR proteins that are active in cancer cells and relatively inactive in healthy cells, ahead of Atrin’s initiation of a Phase 1/2a clinical study of ATRN-119, Atrin’s lead oral drug candidate.

Predictive is using a genomic data base analytics approach to help with patient selection, to increase efficiencies and quality of clinical trials, and to shorten time to market for Atrin’s drug candidates. Atrin’s pipeline also includes preclinical drug candidates in development for glioblastoma and hematological disorders that are being advanced towards IND enabling studies.

Oren Gilad, Ph.D., President and Chief Executive Officer of Atrin Pharmaceuticals, noted: “Our collaboration with Predictive, as shown in this genomics analysis, is already resulting in improved targeting of eligible patients for the upcoming Phase 1/2a ATRN-119 clinical study, and could potentially result in adoption of a new diagnostic for this type of anti-cancer treatment. Predictive’s unique genomic insights and modeling provide Atrin with enhanced diagnostic tools to accelerate Atrin’s DDR therapies and studies.”  Atrin currently expects initiation of the ATRN-119 Phase 1/2a study in 2020, with a first interim clinical readout in 2021.

Bradley Robinson, President and Chief Executive Officer of Predictive Technology Group, stated: “We are pleased to work with Atrin; their cutting-edge work in discovering and advancing DDR therapies will benefit cancer patients with unmet medical needs. We believe that the Atrin collaboration is a ‘game changer’ that will result in improved design and faster clinical advancement of multiple individualized, precision oncology treatments.  By combining our state-of-the-art proprietary screening assay and related artificial intelligence capabilities with Atrin’s breakthrough DDR therapy candidates, we have the potential to become a leader in development of improved personalized oncology therapies. Both of Predictive’s main entities, Predictive Laboratories and Predictive Analytics, are involved in this ongoing DDR research with Atrin.”

Cancer is genomic disease; cancer tumors typically develop when otherwise healthy cells acquire mutations in key “driver genes.” These cancer-causing mutations alter pathways regulating cellular growth and interactions with surrounding tissues.  Understanding the specific gene mutations underlying tumor formation is frequently more important than location of the cancer in selecting personalized anti-cancer therapies.

The key to successful cancer therapy is matching specific cancer mutations with efficient and targeted therapies. Multiple benign diseases, cancer-predisposition syndromes, and cancers have now been linked to mutations in DDR genes.  DDR is a clinically validated therapeutic approach, following the commercial approval of multiple blockbuster Poly ADP Ribose Polymerase (PARP) inhibitor products. DDR drugs already represent a multi-billion-dollar market, and it is expected that DDR drugs may ultimately be used to treat over 200 different cancer targets, if a full set of complementary patient-targeting biomarkers are successfully developed and adopted for commercial use.

Preliminary results from the collaborative genomics analysis using Predictive’s proprietary assays in patients with a specific tumor type found an excess of DDR mutations in cancer cells compared with normal tissue. The analysis identified 92 genes as protein responders to ATRN-119 treatment, of which 18 genes are known TIER 1 cancer-driver genes, and well-characterized mutations were found in three dominant genes. Both in vitro and animal studies have confirmed synthetically-lethal interactions between ATRN-119 treatment and alteration of these three key cancer-causing genes. The overlap between DDR genes responding to ATRN-119 and those mutated in cancer cells suggest that genetic markers underlying response and resistance will be critical to optimizing patient selection in ATRN-119 clinical studies, by increasing clinical efficacy and minimizing systemic toxicities.

Under the terms of the original Atrin-Predictive collaboration agreement, both companies will continue to contribute to the identification of additional druggable targets and pathways, both inside and outside of DDR, to treat a broad group of target indications, particularly in women’s health.

About Atrin Pharmaceuticals

Atrin Pharmaceuticals, based in Doylestown PA, is a private biotech company focused on discovering and developing proprietary precision cancer therapeutics targeting inhibition of DNA Damage and Repair (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 (OTC PINK: PRED) 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 Analytics, 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.atrinpharma.comwww.predtechgroup.com

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