Revenue increases 162% to $43.5 million with $3.5 million in positive cash flow from operations
SALT LAKE CITY, Sept. 30, 2019 — Predictive Technology Group, Inc. (OTC PINK: PRED) (the Company), a leader in the use of data analytics for disease identification and subsequent therapeutic intervention through precision therapeutic treatments, reports financial results for fiscal year 2019 ended June 30, 2019 and provides a business update.
Management Commentary
“Fiscal 2019 fourth quarter revenue up 88%, to $13.4 million, compared to fiscal 2018 fourth quarter, was an all-time quarterly high and capped a highly productive year, with revenue up 162% to $43.5 million and cash flow from operations of $3.5 million,” said Bradley Robinson, CEO of Predictive Technology Group. “Notably, fiscal Q4 marked our 11th consecutive quarter of sequential-quarter revenue growth.
“Over the past year we significantly strengthened our ability to support the successful development and commercialization of proprietary genetic-based diagnostic tests and services, while growing sales of human cell and tissue products,” he added. “We expanded our leadership and Board with highly qualified professionals, opened state-of-the-art laboratories and production facilities, and presented compelling data at leading industry conferences that further validate our genetic approach to develop cutting-edge diagnostics and related therapeutics at early points or intervention. Among highlights was our global infertility research collaboration with Thermo Fisher Scientific to use their market-leading next-generation sequencing technology and technical resources and expertise to commercialize current diagnostics and develop future comprehensive infertility diagnostic solutions. This partnership with a global diagnostics leader is a significant stride forward in securing a leadership role for Predictive in infertility diagnostics.
“In reviewing our diagnostics portfolio, we recently commercialized the PGxPLUS+™ test, which assists physicians in selecting the right medication for patients suffering from chronic pain. Additionally, preparations are underway to launch our genetic testing service for those experiencing infertility, FertilityDX, to select collaborators during the American Society for Reproductive Medicine conference in October,” Robinson said. “In addition to these launches, our near-term focus is on commercializing our endometriosis diagnostic test ARTguide™ and our human cell and tissue products, and on further improving products currently on the market.”
Fiscal Year 2019 and Recent Highlights
Predictive Laboratories
Entered into a global infertility research collaboration with Thermo Fisher Scientific focused on studying the genetic factors that underlie infertility in women. The collaboration combines Predictive’s innovative research and development capabilities with Thermo Fisher Scientific’s market-leading next-generation sequencing technologies and analytical capabilities to better understand the genetics of infertility to facilitate current commercialization and future development of more comprehensive diagnostic solutions.
Achieved a milestone with the collection of 2,500 DNA samples along with comprehensive medical records within five months of acquiring Clinical Laboratory Improvement Act (CLIA) operations in March 2019. The samples are being used to support development of personalized molecular diagnostics and clinical therapies.
Launched ARTguide, a proprietary genetic test for women experiencing infertility as a result of endometriosis and other genetic conditions, to select key opinion leaders in reproductive endocrinology. The Houston Fertility Institute, through its agreement with Predictive, continues to generate clinical utility data to demonstrate improved outcomes from using this test with patients receiving fertility treatment.
Launched PGxPLUS+, a pharmacogenomic test panel marketed to pain clinics for the evaluation of genetic factors that impact a patient’s response to pain medications.
Completed the acquisition and integration of operations for the following companies:
○ Taueret Laboratories, LLC, a provider of genetic testing and DNA analysis services through its CAP/CLIA-certified laboratory, providing for faster entry into the high-growth women’s health testing market with proprietary commercial products.
○ Inception Dx, which included its next-generation sequencing and genotyping assets along with extensive protocols, quality and laboratory management systems and other resources required by a “high complexity” molecular diagnostic laboratory operating under CLIA.
Regenerative Medical Technologies, Inc., which included allogeneic stem cell product design, intellectual property, consented medical records from patients in 13 clinics, and clinical trial methodology for degenerative disc disease.
Announced personnel appointments for Predictive Laboratories including:
○ E. Robert Wassman, MD as Co-Laboratory Director. Dr. Wassman is a pioneer in the introduction of genetic testing and personalized medicine with over 35 years of experience.
○ Christine Seward, MS, CGC as Senior Vice President of Sales and Marketing, bringing extensive experience commercializing molecular diagnostics including products in reproductive medicine from her 16 years at Myriad Genetics.
○ Douglas S. Rabin, MD as Vice President of Medical Affairs, Women’s Health. Dr. Rabin has more than 25 years of experience in women’s healthcare, including both clinical reproductive endocrinology, and obstetrics and gynecology.
○ Lesa Nelson as Chief Operations Officer and Debbie Dyckman as Director of Quality Control, with both joining from the former Taueret Laboratories.
Presented at leading industry conferences as follows:
○ New data demonstrating the genetic basis of endometriosis at the 2019 European Society of Human Reproduction and Embryology annual meeting. Whole exome sequencing was used to identify four genes with significant gene burden in more than 2,500 women with endometriosis. It was found that one in four women with endometriosis carry a mutation in one of these genes, whereas the frequency in the general population is only 8%.
○ New data at the Society for Reproductive Investigation meeting demonstrating the ability of the proprietary genetic test ENDORisk™ to differentiate patients with endometriosis from those without, with a high degree of sensitivity in the Caucasian population.
○ New scientific discoveries concerning the genetics of endometriosis at the 74th American Society for Reproductive Medicine Scientific Congress & Expo. The presentation, “Can Genetic Markers of Endometriosis Predict a Patient’s Responsiveness to Leuprolide Acetate,” presented by Kenneth Ward, MD was recognized with the ASRM Scientific Program Committee’s “Best in Clinical/Population Science Prize Paper” research award.
Entered into a research collaboration with the Preeclampsia Foundation to expand the study of genetic factors associated with this condition. The study will advance the Foundation’s database of preeclampsia medical information and will be utilized by Predictive Laboratories to develop a proprietary test for the early detection of women at risk for preeclampsia.
Predictive Biotech
Appointed Jeff Acuff to the newly created position of Chief Commercial Officer. Mr. Acuff has more than 25 years of commercial and leadership experience and a deep knowledge of the healthcare industry with a record of successful execution in ortho-biologic sales, building high-performing teams and achieving exceptional results.
Completed buildout of a new 15,164 sq. ft. production laboratory and R&D facility that meets good manufacturing Practice (cGMP) and Good Tissue Practice (cGTP) requirements. The lab features an ISO 7 cleanroom and 18 ISO 5 production hoods.
Corporate Developments
Expanded and strengthened the Company’s Board of Directors as follows:
○ John E. Sorrentino as Chairman of the Board in addition to his role as Chair of the Company’s Scientific Advisory Board. Mr. Sorrentino has more than 35 years of life sciences executive experience including 15 years in leadership positions at Wyeth/Pfizer.
○ Senator Orrin G. Hatch, Ronald Barhorst and Jay M. Moyes as directors, bringing exceptional industry, public affairs, financial and governance experience and expanding Board membership to six, including four independent directors.
Appointed Charles Andres, JD, PhD to the Scientific Advisory Board. Dr. Andres leads the life sciences group at the law firm Wilson Sonsini Goodrich & Rosati’s Washington, DC office and has significant expertise in intellectual property, FDA/regulatory, transactions, business and government matters.
Integrated the sales and marketing team from FlagshipHealth Group, previously a consultant contractor, to support commercial activities for Predictive Biotech and Predictive Laboratories through combined domestic direct sales and a nationwide distributor network.
Submitted an application to Nasdaq to list the Company’s common stock.
Filed a Form 10 registration statement with the SEC making the Company subject to the reporting requirements of the Exchange Act, including the filing of annual reports on Form 10-K, quarterly reports on Form 10-Q and periodic reports on Form 8-K, among other requirements.
Fiscal Year 2019 Financial Results
Revenue for fiscal 2019 was $43.5 million, up 162% from $16.6 million for fiscal 2018, with the increase primarily due to higher demand for human cell and tissue products. In fiscal 2019 the Company elevated its presence at trade shows, expanded sales headcount and added several new distributors resulting in sales to more U.S. clinics.
Cost of goods sold for fiscal 2019 were $16.3 million, compared with $4.0 million for fiscal 2018 with the increase mainly due to an increase in the volume of products shipped, as well as increases in quality and regulatory costs, share-based compensation cost and facility costs.
Selling and marketing expenses for fiscal 2019 were $13.9 million, compared with $12.7 million for fiscal 2018. The increase was primarily due to higher commissions and personnel costs related to headcount as the Company continued to expand, partially offset by lower share-based compensation expense related to warrants issued in fiscal 2018 with no similar issuance in fiscal 2019.
General and administration expenses for fiscal 2019 were $18.2 million, compared with $5.8 million for fiscal 2018. The increase was primarily due to higher share-based compensation expense, as well as higher personnel costs and increased outside services costs mainly in connection with public company compliance.
R&D expenses for fiscal 2019 were $5.8 million, compared with $1.9 million for the prior fiscal year, with the increase primarily due to costs related to the development of diagnostic products, and continued development of human cell and tissue product manufacturing methods.
Depreciation and amortization expenses for fiscal 2019 were $9.2 million, compared with $4.6 million for fiscal 2018. The increase was primarily due to an increase in the intangible asset portfolio arising from business combinations, asset acquisitions and costs related to laboratory expansion.
Other loss for fiscal 2019 was $0.8 million, compared with other loss of $0.7 million for fiscal 2018. The change was primarily driven by higher losses from the equity method investment associated with the increasing ownership in Juneau Biosciences, LLC and a decrease in interest income, partially offset by the bargain purchase gain arising from the acquisition of Taueret Laboratories, LLC.
Net loss attributable to controlling interest for fiscal 2019 was $15.3 million, or $0.06 per share, compared with a net loss attributable to controlling interest for fiscal 2018 of $6.1 million, or $0.03 per share.
Cash and cash equivalents as of June 30, 2019 were $1.6 million, compared with $1.2 million as of June 30, 2018. Cash provided by operating activities for fiscal year 2019 was $3.5 million, a significant improvement from cash used in operating activities of $0.3 million for the prior fiscal year. The increase in cash provided by operating activities for the year ended June 30, 2019 compared to the prior year was primarily due to a $2.1 million decrease in the year over year change in inventories, and a $2.5 million increase in the year over year change in accounts payable. These increases were partly offset by an increase in the year over year change in accounts receivable.
FOR COMPLETE DISCLOSURE AND FINANCIAL STATEMENTS:
https://www.sec.gov/Archives/edgar/data/1382943/000109181819000239/pred09272019form10k.htm
About Predictive Biotech, Inc.
Predictive Biotech, Inc., a Salt Lake City-based life sciences company formed in 2015, is a leader in human cell and tissue products for use in cellular therapies and regenerative medicine. A growing national network of clinics, health systems, researchers and physicians leverage Predictive’s four main placental-derived and Wharton’s Jelly umbilical cord-derived products. Predictive Biotech’s current products are regulated by the FDA under 21 CFR part 1271 section 361 as minimally manipulated allografts intended for homologous use.
About Predictive Laboratories, Inc.
Predictive Laboratories owns significant next-generation sequencing and genotyping assets along with extensive protocols, quality and laboratory management systems and other resources required by a high complexity molecular diagnostic laboratory operating under CLIA. The group recently launched its novel test for women experiencing infertility, ARTguide, to selected collaborators. ARTguide is a proprietary gene test panel for women experiencing infertility as a result of endometriosis and other genetic conditions. The test is expected to change the way that Assisted Reproductive Technologies (ART), such as in vitro fertilization (IVF), are used to assist couples having difficulty conceiving a pregnancy.
About Predictive Technology Group, Inc.
Predictive Technology Group aims to revolutionize patient care through predictive data analytics, novel gene-based diagnostics and companion therapeutics through its subsidiaries Predictive Therapeutics, Predictive Biotech, and Predictive Laboratories. These subsidiaries are focused on endometriosis, scoliosis, degenerative disc disease, and human cell and tissue products. The subsidiaries use genetic and other information as cornerstones in the development of new diagnostics that assess a person’s risk of illness and therapeutic products designed to identify, prevent and treat diseases more effectively. Additional information is available at Predtechgroup.com, Predrx.com, Predictivebiotech.com, and Predictivelabs.com.
Forward-Looking Statements
This release contains “forward-looking” statements that are based on present circumstances and on Predictive Technology Group’s predictions with respect to events that have not occurred, that may not occur, or that may occur with different consequences and timing than those now assumed or anticipated. Such forward-looking statements and any statements of the plans and objectives of management for future operations and forecasts of future growth and value, are not guarantees of future performance or results and involve risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements. Such forward-looking statements are made only as of the date of this release and Predictive Technology Group assumes no obligation to update forward-looking statements to reflect subsequent events or circumstances. Readers should not place undue reliance on these forward-looking statements. The information in this press release should be read in conjunction with, and is modified in its entirety by, the Annual Report on Form 10-K (the “Form 10-K”) filed by the Predictive Technology Group with the Securities and Exchange Commission (the “SEC”) and all of the Company’s other public filings with the SEC (the “Public Filings”). In particular, the financial information contained herein is subject to and qualified by reference to the financial statements contained in the Form 10-K and Public Filings, the footnotes thereto and the limitations set forth therein. Investors may not rely on the press release without reference to the Form 10-K and the Public Filings.
->For more information, visit www.predtechgroup.com
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Predictive Technology Group Reports First Quarter Fiscal 2020 Financial Results and Provides Corporate Update
/in Predictive Technology Group /by Yes InternationalSALT LAKE CITY (November 14, 2019) Predictive Technology Group, Inc. (OTCQX: PRED) (“Predictive” or “The Company”), a leader in the development of genetic and molecular diagnostics and companion therapeutics, today announced financial results for the fiscal first quarter ended September 30, 2019 and provided a corporate update.
Management Commentary
“During our first fiscal quarter, we were able to sustain the momentum that carried us through fiscal 2019,” said Bradley C. Robinson, chief executive officer of Predictive Technology Group. “Total revenues for the quarter increased 2.5% year-over-year to $8.3 million, despite the difficult comparison driven by strong sales of human cell and tissue products (HCT/Ps) in the year-ago period.
“Since our last quarterly update, we successfully launched three new DNA-based test panels, including the full market launch of ARTguide™ following the successful Key Opinion Leader (KOL) beta launch, the KOL launch of FertilityDX™ and expanded distribution of PGxPLUS+™. ARTguide™, which helps detect genomic concerns associated with endometriosis and other infertility issues in women, has now been fully commercially launched and we expect material revenues to be generated beginning in calendar 2020. FertilityDX™, which is a comprehensive service that identifies infertility causes, optimizes infertility treatments and reduces risk of complications, is currently in a beta KOL development period. We are on track with the development and distribution of these fertility diagnostic tests that address an unmet need in the complex area of fertility and women’s health.
“In parallel, we achieved a significant milestone in our Predictive Biotech business, having now delivered over 100,000 allografts resulting in over 60,000 patient experiences with no serious adverse events attributable to our products, including AmnioCyte™, AmnioCyte Plus™, PolyCyte™ and CoreCyte™. Moving forward, in our Predictive Therapeutics business, we intend to pursue the FDA’s 351 regulatory pathway as we advance new cellular therapeutic candidates into clinical trials. Securing FDA approval via this pathway requires a rigorous demonstration of a product’s efficacy and safety at a time when the agency has increased its focus on companies offering potentially unsafe human cell and tissue-based products as therapeutic agents. We are in a unique position with our HCT/P platform as the significant safety experience of over 100,000 allografts used in patients in the U.S. market provides the ability to accelerate and de-risk the clinical trial pathway for FDA approved indications. We will announce the specific indications for which we are pursuing FDA approval.
“We are in the early stages of unlocking significant synergies among our business subsidiaries and are working to further advance our broad pipeline of data analytics, therapeutics and diagnostics to benefit both patients and our stakeholders. We are fortunate to have highly experienced members of our advisory teams, management teams and board of directors to bring these products to market and truly improve the quality of life of individuals.”
Fiscal First Quarter and Recent Highlights
Predictive Laboratories
Predictive Biotech
Corporate Developments
Fiscal First Quarter 2020 Results
Revenue from operations (net) for the three months ended September 30, 2019 totaled $8.3 million, compared with $8.1 million for the three months ended September 30, 2018. The increase of $0.2 million was the result of an expansion of the company’s sales force and distribution networks leading to increased sales of HCT/Ps and regenerative medicine products.
Cost of goods sold (“COGS”) includes expenses associated with acquisition and processing, manufacturing (including materials and direct labor), shipping, and other direct expenses relating to the company’s HCT/Ps and regenerative medicine products. Cost of goods sold for the three months ended September 30, 2019 was $7.2 million compared with $3.0 million for the three months ended September 30, 2018. The increase is primarily due to $1.8 million in scrap expense and $1.2 million in increased inventory reserves related to HCT/P product that did not pass quality control, or that is not expected to pass quality control. The increase in quality control failure rates above normal levels was primarily due to a component supplied by a specific vendor. The remaining increase is due to increased share-based compensation cost of $0.4 million, increased personnel costs of $0.5 million, and increased facility costs of $0.2 million.
Sales and marketing expenses for the three months ended September 30, 2019 were $3.2 million, compared with $2.4 million for the three months ended September 30, 2018. The increased sales and marketing expenses resulted from increasing the headcount in the company’s sales force.
Research and development (R&D) expenses for the three months ended September 30, 2019 were $1.8 million, compared with $0.6 million for the three months ended September 30, 2018. The increased research and development expenses resulted from increased focus on product development and additional proprietary research and development work relating to the company’s HCT/Ps and regenerative medicine products. Additionally, we have invested significant amounts in laboratory support in anticipation of the sale of diagnostic products.
General and Administrative (G&A) expenses for the three months ended September 30, 2019 were $6.4 million compared with $2.7 million for the three months ended September 30, 2018. The changes in general and administrative expenses resulted from increased management headcount and share based compensation expense in fiscal 2020.
Amortization and depreciation expense for the three months ended September 30, 2019 was $2.6 million, compared with $1.7 million for the three months ended September 30, 2018. The reason for the increase in amortization and depreciation expense relates primarily to the amortization of intangible assets acquired from acquisitions.
The net loss attributable to common shareholders for the three months ended September 30, 2019 was $7.9 million, or $0.03 per share, versus a net loss attributable to common shareholders for the three months ended September 30, 2018 of $2.0 million, or $0.01 per share.
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 other 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 Biotech, Inc.
Predictive Biotech, Inc., a Salt Lake City-based life sciences company formed in 2015, is a leader in human cell and tissue products for use in cellular therapies and regenerative medicine. A growing national network of clinics, health systems, researchers and physicians leverage Predictive’s four main placental-derived and Wharton’s Jelly umbilical cord-derived products. Predictive Biotech’s current products are regulated by the FDA under 21 CFR part 1271 section 361 as minimally manipulated allografts intended for homologous use.
About Predictive 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 Provides Stock Trading Platform Update
/in Predictive Technology Group, Press Releases /by Yes InternationalSALT LAKE CITY, Nov. 11, 2019 — Predictive Technology Group, Inc. (OTC Pink: PRED), a leader in the development of genetic and molecular diagnostics and companion therapeutics, today announced that effective on November 6, 2019, the company’s shares commenced trading on the Pink® market from the OTCQX® market previously.
Bradley C. Robinson, Chief Executive Officer of Predictive Technology Group, said, “We are aware of the change in trading platform for our shares from the OTCQX® market to the Pink® market. While we are disappointed in and strongly disagree with the OTC’s decision, we remain committed to uplisting to a national securities exchange, and are working through the process of satisfying that exchange’s rigorous listing requirements as expeditiously as possible. In the meantime, the fundamentals of our company remain strong, and we are working tirelessly to become a leader in the development of novel gene-based diagnostics and companion and cellular therapeutics to address serious and debilitating diseases.”
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 Technologies Group Engages LifeSci Partners as Communications Partner
/in Predictive Technology Group, Press Releases /by Yes InternationalLifeSci to develop and execute comprehensive public relations and investor relations programs
SALT LAKE CITY, Oct. 31, 2019 (GLOBE NEWSWIRE) — Predictive Technology Group, Inc. (OTCQX: PRED) (“Predictive” or “The Company”), a leader in the development of genetic and molecular diagnostics and companion therapeutics, announced that it has engaged with LifeSci Partners (“LifeSci”) to increase awareness of the company’s brand and clinical programs.
“We are excited to work with LifeSci to inform the public and the investment community about our innovative data analytics that help physicians identify and combat diseases using our unique treatments and therapeutics,” said Bradley C. Robinson, president and chief executive officer of Predictive. “LifeSci’s expertise in investor relations and public relations, as well as their decades of experience in capital markets, media relations and scientific research have made them the perfect communications partner for our company as we work to grow our business and reach new audiences.”
LifeSci is a leading provider of strategic consulting services in the areas of investor relations, public relations, corporate communications, executive search and capital markets advisory. LifeSci Advisors, LLC and LifeSci Public Relations will provide Predictive with integrated communications services through strategic messaging, investor and media outreach, social and digital media efforts.
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 LifeSci Advisors
LifeSci Advisors is a division of LifeSci Partners (www.lifescipartners.com), a leading provider of consulting services for life sciences clients in the areas of investor relations, public relations, corporate communications, executive search, strategic partnering and capital markets advisory. LifeSci combines deep domain expertise and decades of experience in capital markets and communications with a global network to deliver unparalleled services to clients. LifeSci Advisors is the largest investor relations consultancy in the life sciences industry, founded to provide companies with a multi-faceted approach to investor communications and outreach. LifeSci Advisor’s team of financial services and investor relations specialists synergistically pair with LifeSci Public Relations’ team of MDs and PhDs, positioning the firm to best communicate its clients’ scientific, R&D, regulatory and commercial strategies to diverse audiences. LifeSci Partners’ addition of executive search, strategic partnering and capital markets advisory capabilities provides fully integrated business solutions for life sciences clients across all stages of development.
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 Technologies Group PRED Upgrades to OTCQX® Best Market
/in Predictive Technology Group, Press Releases /by Yes InternationalSALT LAKE CITY, Oct. 24, 2019 (GLOBE NEWSWIRE) — Predictive Technology Group, Inc. (OTCQX: PRED), a leader in the development of genetic and molecular diagnostics and companion therapeutics, today announced that the company has been upgraded to the OTCQX® Best Market from the Pink® market. Effective today, the company’s shares will trade under the ticker “PRED.” U.S. investors can find current financial disclosures and Real-Time Level 2 quotes for the company on www.otcmarkets.com.
“We are pleased to upgrade to the OTCQX® Best Market and believe this is a testament to the Predictive team who work to continuously improve our financial standards and corporate governance practices,” said Bradley C. Robinson, President and Chief Executive Officer of Predictive Technologies Group. “We welcome the broader investor reach and heightened visibility among the investment community that the OTCQX® Best Market confers on its traded companies.”
“We are pleased to be accepted to trade on the OTCQX Best Market. Our previously announced listing application for the NASDAQ Market exchange is currently in the review process,” Mr. Robinson concluded.
Burns Figa & Will PC acted as the company’s OTCQX sponsor.
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 Laboratories Team Led by Laboratory Director Kenneth Ward, M.D. Receives 2019 Endometriosis Special Interest Group Prize Paper Award
/in Predictive Technology Group, Press Releases /by Yes InternationalResearch presented by Dr. Hans Albertsen of Juneau Biosciences advancing knowledge of the genetic factors contributing to endometriosis receives award at the 2019 American Society of Reproductive Medicine (ASRM) Scientific Congress & Expo
SALT LAKE CITY (October 17, 2019) — Predictive Laboratories, a wholly owned molecular and genetic diagnostics company of Predictive Technology Group (OTC Pink: PRED) focused on hard-to-detect diseases, women’s health and infertility, announces Kenneth Ward, M.D., laboratory director of Predictive Laboratories and chief executive officer of Juneau Biosciences; Rakesh Chettier M.S., director of biostatistics of Predictive Laboratories; and Hans Albertsen, Ph.D., chief scientific officer of Juneau Biosciences, have received the 2019 Endometriosis Special Interest Group (EndoSIG) Prize Paper in the “Best in Clinical/Population Science” category.
Dr. Albertsen’s presentation entitled “Cytoskeletal and extra cellular matrix genes are key contributors in the pathogenesis of endometriosis” was delivered at the American Society for Reproductive Medicine (ASRM) 2019 Scientific Congress & Expo in Philadelphia on October 16. EndoSIG is a member group of ASRM aimed at fostering increased interest in the biology, pathophysiology and clinical management of endometriosis.
“We are honored to receive this prestigious award from the ASRM Research Committee,” said Dr. Albertsen. “As endometriosis is generally characterized as a hormonal and inflammatory disease, current therapies often come with significant debilitating side effects. The scientific breaktroughs reported in these award-winning discoveries provide Predictive with insights into new non-hormonal therapies.”
The team’s research is based on the genetic markers of endometriosis discovered by Juneau and Predictive scientists in recent years, and uncovers molecular pathways involved in the pathogenesis of endometriois-induced lesions in women at risk for the disease. Juneau’s gene discovery work in endometriosis was also awarded the EndoSIG Prize Paper in 2015 and 2018.
Dr. Ward, a board-certified physician in obstetrics and gynecology, perinatology, clinical genetics and molecular genetics, presented two scienfic papers at the Annual ASRM meeting: a poster entitled, “Endometriosis risk allele in WNT4 may interact with rare mutations in HDAC2 gene” and an oral abstract entitled, “Somatic cancer driver mutations in endometriosis lesions contribute to secondary cancer risk.”
“We are tremendously proud of Drs. Ward and Albertsen and the teams at Predictive Laboratories and Juneau Biosciences for their research, collaborations and continued devotion to endometriosis and other gene discoveries that advance our understanding of fertility and women’s health, and lead to healthy newborns,” said Bradley Robinson, chief executive officer of Predictive Technology Group. “ASRM brings leaders in reproductive care together from across the world to share findings, inspire new methodology and encourage collaboration to promote further development in reproductive medicine.”
In June 2019, Predictive Laboratories and Thermo Fisher Scientific announced a global research collaboration to study underlying genetic factors contributing to female infertility. The two companies conducted meetings at ASRM in Philadelphia. This partnership pairs Predictive’s innovative research and development capabilities with Thermo Fisher’s market-leading next generation sequencing technology and analytical capabilities to accelerate the understanding of the genetics affecting infertility for future development of diagnostic solutions.
About Predictive Laboratories
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. ARTguide is a blood test that assesses a woman’s endometriosis risk and other genetic causes of infertility in order to optimally navigate the path towards conception. FertilityDX 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.
ELEMENT GLOBAL, INC . (ELGL) LAUNCHES NEW CORPORATE WEBSITE
/in Element Global, Inc., Press Releases /by Yes InternationalLos Angeles, CA- October 15, 2019- ELEMENT GLOBAL, INC. (ELGL:OTCMARKETS) announces its new corporate website, www.elementglobal.com.
The site brings the vision of the Company’s objectives through its many holdings, enabling visitors the opportunity to learn more. As ELGL grows, expect its website to be updated timely to provide comprehensive information.
Merle Ferguson, Chairman at ELGL, states, “Created with the user experience in mind, the site includes many features to help visitors quickly understand the Company’s vertical businesses in mining, energy, sports, technology, media and finance.”
Excited about the new ELGL website, management believes visitors can find information with ease, and enables both customers and shareholders corporate information and content.
One can obtain further information, contact, YES INTERNATIONAL, Investor relations, 757-306-6090, info@elementglobal.com, and www.elementglobal.com. Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: Certain information contained in this release contains forward-looking statements that involve risk and uncertainties, including but not limited to, those relating to development and expansion activities, domestic and global conditions, and market competition
Predictive Technology Group Engages CLSA Capital Markets Limited, a CITIC Securities Company, to Support Product Launches into China’s Rapidly Growing Women’s Health and Fertility Market
/in Predictive Technology Group, Press Releases /by Yes InternationalSALT LAKE CITY –October 15, 2019– Predictive Technology Group, Inc. (OTC PINK: PRED), a leader in the development of genetic and molecular diagnostics and companion therapeutics, announces that it has engaged CLSA Capital Markets Limited, a CITIC Securities Company, to provide introductions to potential strategic partners and regulatory guidance to support the launch of its proprietary genetic-based products into China’s (PRC) rapidly growing markets for women’s health and fertility. Terms of the transaction were not disclosed.
“Given our genetic library, research and understanding of genetics, endometriosis and other factors that may affect a woman’s fertility, we are excited to bring our noninvasive testing technology to this large, emerging market that already surpasses the U.S. in terms of the number of affected women,” said Bradley Robinson, Chief Executive Officer of Predictive Technology Group. “Our tests help both the doctor and patient understand and navigate the barriers to fertility, changing the path to a healthy baby. We are especially pleased to collaborate in this endeavor with CLSA, a leading capital markets and investment group in Asia.”
Predictive expects to introduce ARTguide™ among other fertility diagnostics to the Chinese market. On October 14, 2019, Predictive launched the full U.S. market availability of ARTguide, its test to evaluate the risk for endometriosis and other genetic causes of infertility in women, at the American Society for Reproductive Medicine (ASRM) 2019 Scientific Congress and Expo in Philadelphia.
In 2016 the National Health and Family Planning Commission of the PRC reported that 40 million Chinese couples were experiencing fertility issues. Similarly, the American Society for Reproductive Medicine (ASRM) reported in 2017 that an estimated 25% of Chinese women of childbearing age struggled with infertility issues. In 2018 the European Society of Human Reproduction and Embryology estimated that approximately 800,000 assisted reproductive technology (ART) cycles, such as in vitro fertilization (IVF), were being performed in China annually. Chinese women are driving the fertility markets both in China and medical tourism industries overseas. The global IVF market is expected to grow at an annual rate of 10.2% and to reach $36.2 billion by 2026. The U.S. Center for Disease Control reported that of the patients who sought fertility care in 2017, 284,385 ART cycles were performed resulting in 78,052 live born infants with ART accounting for 1.7% of all infants born in the U.S. annually.
Predictive Laboratories ARTguide Test
ARTguide is the first integrated, DNA-based test that evaluates the risk for endometriosis and other genetic causes of infertility in women. It provides a greater understanding of over a dozen genetic conditions affecting a woman’s fertility by identifying previously invisible barriers to conception, consequently improving ART success rates. ARTguide is appropriate for all women considering use of ART to overcome difficulty conceiving or carrying a pregnancy.
ARTguide was introduced to a limited number of U.S. clinics in 2018. Predictive Laboratories is a wholly owned molecular and genetic diagnostics company of Predictive Technology Group focused on hard-to-detect diseases, women’s health and infertility. Predictive Laboratories recently completed a laboratory expansion to add capacity that allows ARTguide to be available more broadly in the U.S.
Endometriosis
Endometriosis is an estrogen-responsive, chronic condition that arises from extra-uterine growth of the stromal or glandular tissue that line the uterus. Often called the “invisible disease,” endometriosis affects an estimated 1 in 10 women in the U.S. during their reproductive years with many cases go undiagnosed. It is common for a woman to experience symptoms—such as chronic pelvic pain, heavy or painful periods—for a decade or more before a diagnosis is made (13 years, on average, in China). The current standard for diagnosis is laparoscopic surgery, to biopsy lesions found within the fallopian tubes or uterus. Even with this surgery, intraoperative diagnosis by conventional laparoscopic visualization is frequently difficult and inaccurate.
Severe endometriosis with extensive scarring and organ damage is one of the most common causes of female infertility. However, endometriosis can still affect fertility when no symptoms are present. 30% to 50% of women with endometriosis may experience infertility, and 25% to 50% of women who experience infertility have endometriosis.
Studies have linked the risk of endometriosis to ethnicity, with several reporting Asian women’s risk being nine times greater than that of Caucasian women. A recent systematic review analyzing the outcomes of more than 1.9 million Chinese women found endometriosis to be associated with the worsening of obstetric and pregnancy-related outcomes, including miscarriage, pre-term labor, placenta previa, small for gestational age, and caesarean delivery compared to healthy controls.
Predictive Laboratories, Inc.
Predictive Laboratories’ discoveries in molecular and genetic diagnostics focus on unmet needs in women’s health, infertility and other diseases. Predictive offers earlier detection of disease through genetic assessment to guide personalized precision medicine. Leveraging its vast genetic database, Predictive enables the discovery of genes and gene mutations that identify hard-to-diagnose and detect diseases and their prognosis. For more information, visit www.predictivelabs.com.
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.
CLSA Capital Markets Limited
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 21 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.
For more information, visit www.predtechgroup.com
Predictive Laboratories Launches FertilityDX™
/in Predictive Technology Group, Press Releases /by Yes InternationalGenetic testing service now available to identify causes of infertility and guide personalized fertility treatments
SALT LAKE CITY, Oct. 14, 2019– Predictive Laboratories, a wholly owned molecular and genetic diagnostics company of Predictive Technology Group (OTC Pink: PRED) focused on hard-to-detect diseases, women’s health and infertility, announces the launch of FertilityDX™, a comprehensive genetic testing service that identifies barriers to healthy pregnancy and birth, allowing doctors to tailor fertility treatments. The test launch will be formally announced at the American Society for Reproductive Medicine (ASRM) 2019 Scientific Congress and Expo, Oct. 12-16 in Philadelphia.
“For the one in eight couples who struggle with infertility, trying to have a child can be financially, physically and emotionally exhausting—largely because the couple doesn’t know why they are having difficulty conceiving,” said Kenneth Ward, M.D., Laboratory Director of Predictive Laboratories. Dr. Ward is a board-certified physician in obstetrics and gynecology, perinatology, clinical genetics and molecular genetics. “Our desire is to arm couples considering assisted reproductive technologies (ART) with an understanding of the genetic and medical obstacles that may be affecting their fertility and provide doctors with genetically relevant information to help their patients have a healthy baby.”
FertilityDX provides information by evaluating three key areas: contributors to (or causes of) infertility, risks of pregnancy complications, and risks for serious genetic conditions in offspring.
FertilityDX supports both physician and patient throughout the entirety of the treatment process. Patients are provided with pretest counseling and clear and relevant test results. Physicians get an easy-to-understand final report and access to a variety of genetics consultants. The test will be launched in select fertility clinics across the United States, offering couples access to the most comprehensive genetic service to date.
About Predictive Laboratories
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. ARTguide is a blood test that assesses a woman’s endometriosis risk and other genetic causes of infertility in order to optimally navigate the path towards conception. FertilityDX 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, 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.
Predictive Laboratories Announces Commercialization And Full Market Availability Of ARTguide™ At American Society Of Reproductive Medicine (ASRM) Scientific Congress And Expo
/in Predictive Technology Group, Press Releases /by Yes InternationalCompany also presenting two oral and one poster scientific presentations at ASRM
SALT LAKE CITY, Oct. 10, 2019 — Predictive Laboratories, a wholly owned molecular and genetic diagnostics company of Predictive Technology Group (OTC Pink: PRED) focused on hard-to-detect diseases, women’s health and infertility, announces the commercialization and full market availability of ARTguide, the first integrated, DNA-based test that evaluates the risk for endometriosis and other genetic causes of infertility in women. After a successful beta launch, Predictive Laboratories completed a laboratory expansion that will allow ARTguide to now be available in fertility clinics across the United States.
“Endometriosis can be a debilitating disease for many women as it can cause severe pelvic pain, inflammation, adhesions to the fallopian tubes and uterus, and often, infertility,” said Kenneth Ward, M.D., Laboratory Director of Predictive Laboratories. “Nearly 50% of women who struggle with infertility have endometriosis, but because surgery is required for a definitive diagnosis, oftentimes it remains undiagnosed. ARTguide can predict a patient’s risk of endometriosis early on so that women have a better understanding of their barriers to conception, and therefore their physician can create a more personalized infertility treatment plan.”
ARTguide provides a greater understanding of over a dozen genetic conditions affecting a woman’s fertility by identifying previously invisible barriers to conception and improving success rates in assisted reproductive technologies (ART), such as in vitro fertilization (IVF). ARTguide tests for hundreds of genetic markers of endometriosis and 80 other additional mutations causing conditions such as ovarian failure, that may impact fertility. Through the identification of genetic infertility risk factors, ARTguide helps women optimally navigate their path towards conception and a healthy birth. ARTguide is appropriate for all women considering use of ART to overcome difficulty conceiving or carrying a pregnancy.
ARTguide’s full market availability will be announced during the American Society for Reproductive Medicine (ASRM) 2019 Scientific Congress and Expo, Oct. 12 – 16 in Philadelphia. In addition to sharing this news, Dr. Ward, a board-certified physician in obstetrics and gynecology, perinatology, clinical genetics and molecular genetics, will present two scientific papers at ASRM. The schedule of his speaking engagements are as follows:
Wednesday, Oct. 16 at 6:30 a.m. ET — Poster presentation: Endometriosis risk allele in WNT4 may interact with rare mutatins in HDAC2 gene
Wednesday, Oct. 16 at 11:15 a.m. ET — Oral abstract: Somatic cancer driver mutations in endometriosis lesions contribute to secondary cancer risk
Dr. Ward’s colleague, Hans Albertsen, Ph.D., will present additional endometriosis data on Wednesday, Oct. 16 at 11:30 a.m. ET — Oral abstract: Cytoskeletal and extracellular matrix genes are key contributors in the pathogenesis of endometriosis.
About Predictive Laboratories
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. ARTguide is a blood test that assesses a woman’s endometriosis risk and other genetic causes of infertility in order to optimally navigate the path towards conception. FertilityDX 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.
Predictive Technology Group Reports Fiscal Year 2019 Financial Results
/in Predictive Technology Group /by Yes InternationalRevenue increases 162% to $43.5 million with $3.5 million in positive cash flow from operations
SALT LAKE CITY, Sept. 30, 2019 — Predictive Technology Group, Inc. (OTC PINK: PRED) (the Company), a leader in the use of data analytics for disease identification and subsequent therapeutic intervention through precision therapeutic treatments, reports financial results for fiscal year 2019 ended June 30, 2019 and provides a business update.
Management Commentary
“Fiscal 2019 fourth quarter revenue up 88%, to $13.4 million, compared to fiscal 2018 fourth quarter, was an all-time quarterly high and capped a highly productive year, with revenue up 162% to $43.5 million and cash flow from operations of $3.5 million,” said Bradley Robinson, CEO of Predictive Technology Group. “Notably, fiscal Q4 marked our 11th consecutive quarter of sequential-quarter revenue growth.
“Over the past year we significantly strengthened our ability to support the successful development and commercialization of proprietary genetic-based diagnostic tests and services, while growing sales of human cell and tissue products,” he added. “We expanded our leadership and Board with highly qualified professionals, opened state-of-the-art laboratories and production facilities, and presented compelling data at leading industry conferences that further validate our genetic approach to develop cutting-edge diagnostics and related therapeutics at early points or intervention. Among highlights was our global infertility research collaboration with Thermo Fisher Scientific to use their market-leading next-generation sequencing technology and technical resources and expertise to commercialize current diagnostics and develop future comprehensive infertility diagnostic solutions. This partnership with a global diagnostics leader is a significant stride forward in securing a leadership role for Predictive in infertility diagnostics.
“In reviewing our diagnostics portfolio, we recently commercialized the PGxPLUS+™ test, which assists physicians in selecting the right medication for patients suffering from chronic pain. Additionally, preparations are underway to launch our genetic testing service for those experiencing infertility, FertilityDX, to select collaborators during the American Society for Reproductive Medicine conference in October,” Robinson said. “In addition to these launches, our near-term focus is on commercializing our endometriosis diagnostic test ARTguide™ and our human cell and tissue products, and on further improving products currently on the market.”
Fiscal Year 2019 and Recent Highlights
Predictive Laboratories
Entered into a global infertility research collaboration with Thermo Fisher Scientific focused on studying the genetic factors that underlie infertility in women. The collaboration combines Predictive’s innovative research and development capabilities with Thermo Fisher Scientific’s market-leading next-generation sequencing technologies and analytical capabilities to better understand the genetics of infertility to facilitate current commercialization and future development of more comprehensive diagnostic solutions.
Achieved a milestone with the collection of 2,500 DNA samples along with comprehensive medical records within five months of acquiring Clinical Laboratory Improvement Act (CLIA) operations in March 2019. The samples are being used to support development of personalized molecular diagnostics and clinical therapies.
Launched ARTguide, a proprietary genetic test for women experiencing infertility as a result of endometriosis and other genetic conditions, to select key opinion leaders in reproductive endocrinology. The Houston Fertility Institute, through its agreement with Predictive, continues to generate clinical utility data to demonstrate improved outcomes from using this test with patients receiving fertility treatment.
Launched PGxPLUS+, a pharmacogenomic test panel marketed to pain clinics for the evaluation of genetic factors that impact a patient’s response to pain medications.
Completed the acquisition and integration of operations for the following companies:
○ Taueret Laboratories, LLC, a provider of genetic testing and DNA analysis services through its CAP/CLIA-certified laboratory, providing for faster entry into the high-growth women’s health testing market with proprietary commercial products.
○ Inception Dx, which included its next-generation sequencing and genotyping assets along with extensive protocols, quality and laboratory management systems and other resources required by a “high complexity” molecular diagnostic laboratory operating under CLIA.
Regenerative Medical Technologies, Inc., which included allogeneic stem cell product design, intellectual property, consented medical records from patients in 13 clinics, and clinical trial methodology for degenerative disc disease.
Announced personnel appointments for Predictive Laboratories including:
○ E. Robert Wassman, MD as Co-Laboratory Director. Dr. Wassman is a pioneer in the introduction of genetic testing and personalized medicine with over 35 years of experience.
○ Christine Seward, MS, CGC as Senior Vice President of Sales and Marketing, bringing extensive experience commercializing molecular diagnostics including products in reproductive medicine from her 16 years at Myriad Genetics.
○ Douglas S. Rabin, MD as Vice President of Medical Affairs, Women’s Health. Dr. Rabin has more than 25 years of experience in women’s healthcare, including both clinical reproductive endocrinology, and obstetrics and gynecology.
○ Lesa Nelson as Chief Operations Officer and Debbie Dyckman as Director of Quality Control, with both joining from the former Taueret Laboratories.
Presented at leading industry conferences as follows:
○ New data demonstrating the genetic basis of endometriosis at the 2019 European Society of Human Reproduction and Embryology annual meeting. Whole exome sequencing was used to identify four genes with significant gene burden in more than 2,500 women with endometriosis. It was found that one in four women with endometriosis carry a mutation in one of these genes, whereas the frequency in the general population is only 8%.
○ New data at the Society for Reproductive Investigation meeting demonstrating the ability of the proprietary genetic test ENDORisk™ to differentiate patients with endometriosis from those without, with a high degree of sensitivity in the Caucasian population.
○ New scientific discoveries concerning the genetics of endometriosis at the 74th American Society for Reproductive Medicine Scientific Congress & Expo. The presentation, “Can Genetic Markers of Endometriosis Predict a Patient’s Responsiveness to Leuprolide Acetate,” presented by Kenneth Ward, MD was recognized with the ASRM Scientific Program Committee’s “Best in Clinical/Population Science Prize Paper” research award.
Entered into a research collaboration with the Preeclampsia Foundation to expand the study of genetic factors associated with this condition. The study will advance the Foundation’s database of preeclampsia medical information and will be utilized by Predictive Laboratories to develop a proprietary test for the early detection of women at risk for preeclampsia.
Predictive Biotech
Appointed Jeff Acuff to the newly created position of Chief Commercial Officer. Mr. Acuff has more than 25 years of commercial and leadership experience and a deep knowledge of the healthcare industry with a record of successful execution in ortho-biologic sales, building high-performing teams and achieving exceptional results.
Completed buildout of a new 15,164 sq. ft. production laboratory and R&D facility that meets good manufacturing Practice (cGMP) and Good Tissue Practice (cGTP) requirements. The lab features an ISO 7 cleanroom and 18 ISO 5 production hoods.
Corporate Developments
Expanded and strengthened the Company’s Board of Directors as follows:
○ John E. Sorrentino as Chairman of the Board in addition to his role as Chair of the Company’s Scientific Advisory Board. Mr. Sorrentino has more than 35 years of life sciences executive experience including 15 years in leadership positions at Wyeth/Pfizer.
○ Senator Orrin G. Hatch, Ronald Barhorst and Jay M. Moyes as directors, bringing exceptional industry, public affairs, financial and governance experience and expanding Board membership to six, including four independent directors.
Appointed Charles Andres, JD, PhD to the Scientific Advisory Board. Dr. Andres leads the life sciences group at the law firm Wilson Sonsini Goodrich & Rosati’s Washington, DC office and has significant expertise in intellectual property, FDA/regulatory, transactions, business and government matters.
Integrated the sales and marketing team from FlagshipHealth Group, previously a consultant contractor, to support commercial activities for Predictive Biotech and Predictive Laboratories through combined domestic direct sales and a nationwide distributor network.
Submitted an application to Nasdaq to list the Company’s common stock.
Filed a Form 10 registration statement with the SEC making the Company subject to the reporting requirements of the Exchange Act, including the filing of annual reports on Form 10-K, quarterly reports on Form 10-Q and periodic reports on Form 8-K, among other requirements.
Fiscal Year 2019 Financial Results
Revenue for fiscal 2019 was $43.5 million, up 162% from $16.6 million for fiscal 2018, with the increase primarily due to higher demand for human cell and tissue products. In fiscal 2019 the Company elevated its presence at trade shows, expanded sales headcount and added several new distributors resulting in sales to more U.S. clinics.
Cost of goods sold for fiscal 2019 were $16.3 million, compared with $4.0 million for fiscal 2018 with the increase mainly due to an increase in the volume of products shipped, as well as increases in quality and regulatory costs, share-based compensation cost and facility costs.
Selling and marketing expenses for fiscal 2019 were $13.9 million, compared with $12.7 million for fiscal 2018. The increase was primarily due to higher commissions and personnel costs related to headcount as the Company continued to expand, partially offset by lower share-based compensation expense related to warrants issued in fiscal 2018 with no similar issuance in fiscal 2019.
General and administration expenses for fiscal 2019 were $18.2 million, compared with $5.8 million for fiscal 2018. The increase was primarily due to higher share-based compensation expense, as well as higher personnel costs and increased outside services costs mainly in connection with public company compliance.
R&D expenses for fiscal 2019 were $5.8 million, compared with $1.9 million for the prior fiscal year, with the increase primarily due to costs related to the development of diagnostic products, and continued development of human cell and tissue product manufacturing methods.
Depreciation and amortization expenses for fiscal 2019 were $9.2 million, compared with $4.6 million for fiscal 2018. The increase was primarily due to an increase in the intangible asset portfolio arising from business combinations, asset acquisitions and costs related to laboratory expansion.
Other loss for fiscal 2019 was $0.8 million, compared with other loss of $0.7 million for fiscal 2018. The change was primarily driven by higher losses from the equity method investment associated with the increasing ownership in Juneau Biosciences, LLC and a decrease in interest income, partially offset by the bargain purchase gain arising from the acquisition of Taueret Laboratories, LLC.
Net loss attributable to controlling interest for fiscal 2019 was $15.3 million, or $0.06 per share, compared with a net loss attributable to controlling interest for fiscal 2018 of $6.1 million, or $0.03 per share.
Cash and cash equivalents as of June 30, 2019 were $1.6 million, compared with $1.2 million as of June 30, 2018. Cash provided by operating activities for fiscal year 2019 was $3.5 million, a significant improvement from cash used in operating activities of $0.3 million for the prior fiscal year. The increase in cash provided by operating activities for the year ended June 30, 2019 compared to the prior year was primarily due to a $2.1 million decrease in the year over year change in inventories, and a $2.5 million increase in the year over year change in accounts payable. These increases were partly offset by an increase in the year over year change in accounts receivable.
FOR COMPLETE DISCLOSURE AND FINANCIAL STATEMENTS:
https://www.sec.gov/Archives/edgar/data/1382943/000109181819000239/pred09272019form10k.htm
About Predictive Biotech, Inc.
Predictive Biotech, Inc., a Salt Lake City-based life sciences company formed in 2015, is a leader in human cell and tissue products for use in cellular therapies and regenerative medicine. A growing national network of clinics, health systems, researchers and physicians leverage Predictive’s four main placental-derived and Wharton’s Jelly umbilical cord-derived products. Predictive Biotech’s current products are regulated by the FDA under 21 CFR part 1271 section 361 as minimally manipulated allografts intended for homologous use.
About Predictive Laboratories, Inc.
Predictive Laboratories owns significant next-generation sequencing and genotyping assets along with extensive protocols, quality and laboratory management systems and other resources required by a high complexity molecular diagnostic laboratory operating under CLIA. The group recently launched its novel test for women experiencing infertility, ARTguide, to selected collaborators. ARTguide is a proprietary gene test panel for women experiencing infertility as a result of endometriosis and other genetic conditions. The test is expected to change the way that Assisted Reproductive Technologies (ART), such as in vitro fertilization (IVF), are used to assist couples having difficulty conceiving a pregnancy.
About Predictive Technology Group, Inc.
Predictive Technology Group aims to revolutionize patient care through predictive data analytics, novel gene-based diagnostics and companion therapeutics through its subsidiaries Predictive Therapeutics, Predictive Biotech, and Predictive Laboratories. These subsidiaries are focused on endometriosis, scoliosis, degenerative disc disease, and human cell and tissue products. The subsidiaries use genetic and other information as cornerstones in the development of new diagnostics that assess a person’s risk of illness and therapeutic products designed to identify, prevent and treat diseases more effectively. Additional information is available at Predtechgroup.com, Predrx.com, Predictivebiotech.com, and Predictivelabs.com.
Forward-Looking Statements
This release contains “forward-looking” statements that are based on present circumstances and on Predictive Technology Group’s predictions with respect to events that have not occurred, that may not occur, or that may occur with different consequences and timing than those now assumed or anticipated. Such forward-looking statements and any statements of the plans and objectives of management for future operations and forecasts of future growth and value, are not guarantees of future performance or results and involve risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements. Such forward-looking statements are made only as of the date of this release and Predictive Technology Group assumes no obligation to update forward-looking statements to reflect subsequent events or circumstances. Readers should not place undue reliance on these forward-looking statements. The information in this press release should be read in conjunction with, and is modified in its entirety by, the Annual Report on Form 10-K (the “Form 10-K”) filed by the Predictive Technology Group with the Securities and Exchange Commission (the “SEC”) and all of the Company’s other public filings with the SEC (the “Public Filings”). In particular, the financial information contained herein is subject to and qualified by reference to the financial statements contained in the Form 10-K and Public Filings, the footnotes thereto and the limitations set forth therein. Investors may not rely on the press release without reference to the Form 10-K and the Public Filings.
->For more information, visit www.predtechgroup.com
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