On March 2, 2020 Proscia, a leading provider of artificial intelligence (AI) enabled digital pathology solutions, and the University of California, San Francisco (UCSF) reported that they have partnered to introduce artificial intelligence into the practice of pathology (Press release, Proscia, MAR 2, 2020, View Source [SID1234555077]). Beginning with prostate cancer, the second leading cause of cancer deaths among men in the U.S., the collaboration will validate the clinical efficacy of computational pathology applications for several high-impact pathology subspecialties.

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The standard of care for diagnosing cancer relies on the pathologist’s assessment of tissue biopsies viewed under a microscope. This 150-year-old manual and subjective practice cannot keep pace with the rising cancer burden amid a decreasing pathologist workforce. Prostate cancer diagnosis is especially problematic given its high slide-per-case volume, complex reporting requirements, and qualitative grading system, often leading to delayed turnaround times, increased use of ancillary tests, and reduced confidence in treatment decisions.

Proscia and UCSF are collaborating on the validation of computational pathology applications that drive much-needed quality and efficiency gains for clinical laboratories using digital pathology. As one of the earliest adopters of digital pathology for primary diagnosis, UCSF has amassed volumes of diverse, high-quality digitized data. This data is initially being used to ensure that Proscia’s computational pathology application for prostate cancer accurately accounts for the variability that exists across a wide range of diagnoses, methods of biopsy and tissue preparation, tissue staining procedures, and digital scanning processes.

"As prostate cancer impacts millions of patients each year, it is critical that we improve productivity and confidence in this high-impact specialty," said Mike Bonham, Proscia’s Chief Medical Officer. "Through our partnership with UCSF, an institution that achieves the highest standards in patient care, research, and education, we are gaining the data and experience required to ensure that our AI delivers meaningful benefits in practice, where so many other solutions have struggled to perform."

Beyond their initial work in prostate cancer, Proscia and UCSF will expand their focus to accelerate the introduction of similar solutions that advance the practice of pathology for subspecialty-specific processes making up the majority of pathology cases. As digital pathology continues to gain traction, these deep learning-enabled applications will drive its adoption by unlocking new diagnostic information that furthers discovery and improves patient outcomes.

"UCSF prides itself as being an institution in the intersection of research and clinical practice of medicine, continuously working to translate new findings into more effective prevention, diagnosis, and treatment," said Zoltan Laszik, Professor of Pathology at UCSF. "Proscia’s focus on delivering practical AI solutions strongly aligns with our efforts, and we are pleased to work together to improve the routine pathology workflow."

This partnership adds to the growing list of leading academic and commercial labs with which Proscia is working to bring computational pathology applications to market. In December 2019, the company announced a data collaboration with Johns Hopkins School of Medicine. Last week, Proscia released the results of the largest AI validation study in pathology, conducted in collaboration with Dermatopathology Laboratory of Central States, University of Florida, and Thomas Jefferson University Hospital, in support of the June 2019 release of its DermAI application for dermatopathology.

On March 2, 2020 Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH), a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, reported that it will report its fourth quarter and full year 2019 financial results on Monday, March 9, 2020 (Press release, Deciphera Pharmaceuticals, MAR 2, 2020, View Source [SID1234555018]).

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In connection with the earnings release, Deciphera’s management team will host a live conference call and webcast at 4:30 PM ET on Monday, March 9, 2020, to discuss the Company’s financial results and provide a general corporate update.

The conference call may be accessed by dialing (866) 930-5479 (domestic) or (409) 216-0603 (international) and referring to conference ID 1669368. A webcast of the conference call will be available in the "Events and Presentations" page in the "Investors" section of the Company’s website at View Source The archived webcast will be available on the Company’s website approximately two hours after the conference call and will be available for 30 days following the call.

On March 2, 2020 Veracyte, Inc., (Nasdaq: VCYT) reported the publication of a large, retrospective study in which the Danish Breast Cancer Group (DBCG) used the Prosigna breast cancer prognostic gene signature assay to identify which women were more likely to benefit from aggressive chemotherapy based on their intrinsic breast cancer subtype (Press release, Veracyte, MAR 2, 2020, View Source [SID1234555046]). The findings appear online in npj Breast Cancer, a peer-reviewed open-source journal, and suggest that women with HER2-enriched subtypes may benefit from commonly used anthracycline-containing chemotherapy regimens, while those with luminal breast cancer subtypes – which accounted for 30 percent of the women in the study – could potentially be spared such treatment regimens, which have significant cardiotoxicity in some patients.

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The findings are from a retrospective analysis of the DBCG89D trial – a prospectively designed, randomized trial of 980 pre- and post-menopausal Danish women with early-stage breast cancer who were administered adjuvant chemotherapy regimens that contained anthracycline (epirubicin) or were CMF- (cyclophosphamide, methotrexate and fluorouracil) based. Among the 686 women with Prosigna results, overall survival was significantly different in anthracycline- versus non-anthracycline treated patients with HER2-enriched (Hazard Ratio of 0.72, 95% Confidence Interval 0.52; 0.99) tumors, but not in patients with luminal A (Hazard Ratio of 1.62, 95% Confidence Interval 0.97; 2.71) or luminal B (Hazard Ratio of 1.41, 95% Confidence Interval 0.80; 2.47) cancers. Of the 686 women with Prosigna results, the test identified 132 women with luminal A, 78 with luminal B, 259 with basal-like and 217 with HER2-enriched breast cancer subtypes.

"Our study was a carefully planned, formal re-analysis of an important Danish clinical trial that helped establish the use of anthracycline chemotherapies in breast cancer — an aggressive treatment that saves lives but can have serious side effects, including heart damage," said Torsten Nielsen, M.D., Ph.D., professor of pathology and laboratory medicine at BC Cancer, the University of British Columbia, a co-author of the study and a developer of the gene signature on which the Prosigna test is based.

"By applying Prosigna technology, which had not yet been invented when the tumor tissue from this trial was originally collected and stored, we found that patients with luminal subtypes did not benefit from putting anthracycline drugs into the chemotherapy regimen. These drugs only provided added benefit to those with non-luminal molecular subtypes. The study contributes to the accumulating body of evidence that the breast cancer molecular subtypes and risk scores identified with Prosigna technology can help identify which women can safely back off of aggressive chemotherapy."

The Prosigna test uses advanced genomic technology to inform next steps for patients with early-stage breast cancer, based on the genomic make-up of their disease. The test analyzes the activity of 50 genes known as the PAM50 gene signature, along with clinical-pathological features, and can provide a hormone-receptor positive early breast cancer patient and her physician with a prognostic score indicating the probability of cancer recurrence during the next 10 years. Outside of the United States, it is also utilized to provide PAM50 molecular subtype information.

"These new data suggest that the Prosigna test may be able to offer new levels of individualized treatment for women with early-stage breast cancer, potentially enabling many to avoid more aggressive chemotherapy regimens," said Bonnie Anderson, Veracyte’s chairman and chief executive officer. "These findings also suggest exciting future expansion opportunities for the Prosigna test’s positioning in global markets where intrinsic breast cancer subtypes are reported in the test results."

Veracyte acquired the Prosigna test from NanoString Technologies, Inc. in December 2019 as part of its acquisition of the exclusive global diagnostic rights to the nCounter FLEX Analysis System. The DBCG retrospective study was supported by funds from NanoString Technologies.

About the Prosigna Breast Cancer Prognostic Gene Signature Assay

Physicians use Prosigna to help guide therapeutic decisions so that patients receive therapeutic interventions, such as chemotherapy, only if clinically warranted. The in vitro diagnostic test is indicated in female breast cancer patients who have undergone surgery in conjunction with locoregional treatment consistent with standard of care, either as:

A prognostic indicator for distant recurrence‐free survival at ten years in post‐menopausal women with Hormone Receptor‐Positive (HR+), lymph node‐negative, Stage I or II breast cancer to be treated with adjuvant endocrine therapy alone, when used in conjunction with other clinicopathological factors; or
A prognostic indicator for distant recurrence‐free survival at ten years in post‐menopausal women with Hormone Receptor‐Positive (HR+), lymph node‐positive (1‐3 positive nodes), Stage II breast cancer to be treated with adjuvant endocrine therapy alone, when used in conjunction with other clinicopathological factors. The device is not intended for patients with 4 or more positive nodes.
The Prosigna test is FDA 510(k) cleared in the United States for use on the nCounter Dx Analysis System and is available for use when ordered by a physician. The test is performed on formalin-fixed and paraffin-embedded tissue. The Prosigna test has been CE-marked, showing that it conforms with European Union regulations, and is available for use by healthcare professionals in the European Union and other countries that recognize the CE mark, as well as in Canada, Israel, Australia, New Zealand and Hong Kong. The test is covered by Medicare and leading private payers in the United States and is widely covered by government and private payers in the countries where it is available.

On March 2, 2020 Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, reported its fourth quarter financial results for 2019 (Press release, Intrexon, MAR 2, 2020, View Source [SID1234555062]).

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Recent Business Highlights:

The Company announced the appointment of Helen Sabzevari, PhD as President and CEO of Precigen and Randal J. Kirk as Executive Chairman effective as of January 1, 2020. The Company also changed its name to Precigen, Inc. from Intrexon Corporation and its Nasdaq stock symbol to PGEN from XON effective February 1, 2020;

The Company closed sales of a number of its assets for an aggregate of $65.2 million and sold $35 million of its common stock in January 2020, thereby alleviating the going concern qualification associated with its 2019 consolidated financial statements as well as further streamlining corporate focus;

The Company sold its ownership stake in AquaBounty Technologies, Inc. (Nasdaq: AQB) in October 2019 for proceeds of $21.6 million;

Precigen announced that the US Food and Drug Administration (FDA) granted orphan drug designation (ODD) to PRGN-3006, a first-in-class investigational therapy using Precigen’s non-viral UltraCAR-T therapeutic platform for patients with relapsed or refractory acute myeloid leukemia (AML) and higher risk myelodysplastic syndromes (MDS) (clinical trial identifier: NCT03927261);

Precigen ActoBio, Inc., a wholly-owned subsidiary of Precigen, collaboration partner Oragenics, Inc. (NYSE American: OGEN) completed enrollment in the Phase 2 trial of AG013, an easy to use oral rinsing system designed to prevent and treat oral mucositis; and

Triple-Gene LLC, a majority-owned subsidiary of Precigen, completed the Phase 1 trial enrollment and reported preliminary data of its investigational multigenic gene therapy INXN-4001 for the treatment of heart failure.

Fourth Quarter 2019 Financial Highlights:

Total revenues from continuing operations of $17.0 million;

Net loss of $169.2 million attributable to Precigen, or $(1.09) per basic share, of which $95.7 million was from discontinued operations and an additional $33.8 million was for non-cash charges related to continuing operations; and

Cash, cash equivalents, and short-term investments for continuing operations totaled $75.1 million at December 31, 2019.

Full Year 2019 Financial Highlights:

Total revenues from continuing operations of $90.7 million;

Net loss of $322.3 million attributable to Precigen, or $(2.09) per basic share, of which $116.2 million was from discontinued operations and an additional $70.4 million was for non-cash charges related to continuing operations.

"I am confident that we will make important advances this year in our mission to improve patient care through innovative gene and cell therapies," said Dr. Sabzevari. "We enter 2020 with cash resources that we believe are sufficient for us to deliver on several value-creating milestones during the year across our clinical pipeline. At the same time, we are laser-focused on aligning our portfolio, streamlining operations and maximizing organizational structures to improve operational efficiency going forward."

Fourth Quarter 2019 Financial Results Compared to Prior Year Period

Total revenues decreased $24.2 million from the quarter ended December 31, 2018. Collaboration and licensing revenues decreased $24.6 million, or 103%, from the quarter ended December 31, 2018 primarily due to the reacquisition of rights previously licensed to some of Precigen’s collaborators in the second half of 2018 and the result of which eliminated or substantially reduced revenues previously generated from those collaborations. Additionally, collaboration and licensing revenues from collaborations with other collaborators decreased due to lower demand for research and development services in the current year period.

Research and development expenses decreased $252.2 million, or 92%. The 2018 amounts include a $228.0 million expense related to in-process research and development reacquired from former collaborators. Selling, general and administrative (SG&A) expenses increased $6.3 million, or 28% which was primarily attributable to increased compensation expenses related to performance and retention incentives for SG&A employees, partially offset by (i) decreased share-based compensation expense which arose primarily from the departure of former employees during the first half of the current year; and (ii) fewer legal fees associated with the Company’s Trans Ova subsidiary. The Company also recorded a $29.6 million goodwill impairment charge in the fourth quarter of 2019 related to its Trans Ova subsidiary.

Full Year 2019 Financial Results Compared to Prior Year Period

Total revenues decreased $60.5 million from the year ended December 31, 2018. Collaboration and licensing revenues decreased $55.5 million, or 80%, from the year ended December 31, 2018 primarily due to the reacquisition of rights previously licensed to some of Precigen’s collaborators in the second half of 2018 and the result of which eliminated or substantially reduced revenues previously generated from those collaborations. Additionally, in 2018, the Company recognized additional revenues from the acceleration of previously deferred revenue upon mutual termination of certain collaborations. Product revenues decreased $4.7 million, or 17%, primarily due to lower customer demand in the beef and dairy industries resulting in fewer sales of pregnant cows and calf products. Gross margin on products also declined in the current period as a result of fewer products sold.

Research and development expenses decreased $264.4 million, or 72%. The 2018 amounts include $236.7 million of expenses related to in-process research and development reacquired from former collaborators. SG&A expenses decreased $24.9 million, or 20%. SG&A salaries, benefits, and other personnel costs decreased $14.9 million primarily due to decreased share-based compensation expense as a result of the reversal of previously recognized expense for unvested options granted to former employees as well as the conclusion of the vesting period for other previously granted stock options. Legal and professional fees decreased $6.1 million primarily due to fewer legal fees associated with the Company’s Trans Ova subsidiary. The Company also recorded a $29.6 million goodwill impairment charge in the fourth quarter of 2019 related to its Trans Ova subsidiary.

Conference Call and Webcast

Precigen will host a conference call today Monday March 2nd at 5:30 PM ET to discuss the results and provide a general business update. The conference call may be accessed by dialing 1-888-317-6003 (Domestic US), 1-866-284-3684 (Canada), and 1-412-317-6061 (International) and providing the number 4230814 to join the Precigen Conference Call. Participants may also access the live webcast through Precigen’s website in the Events section at View Source

Precigen: Advancing Medicine with Precision

Precigen (Nasdaq: PGEN) is a dedicated discovery and clinical stage biopharmaceutical company advancing the next generation of gene and cell therapies using precision technology to target urgent and intractable diseases in our core therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases. Our technologies enable us to find innovative solutions for affordable biotherapeutics in a controlled manner. Precigen operates as an innovation engine progressing a preclinical and clinical pipeline of well-differentiated unique therapies toward clinical proof-of-concept and commercialization. For more information about Precigen, visit www.precigen.com or follow us on Twitter @Precigen and LinkedIn.

Trademarks

Precigen, UltraCAR-T, and Advancing Medicine with Precision are trademarks of Precigen and/or its affiliates. Other names may be trademarks of their respective owners.

On March 2, 2020 Protagonist Therapeutics, Inc. (Nasdaq:PTGX) reported that it will announce fourth quarter and year end 2019 financial results after the NASDAQ market closes on Tuesday, March 10, 2020 (Press release, Protagonist, MAR 2, 2020, View Source [SID1234555078]). Protagonist management will host a year end update call at 4:30 p.m. EDT/1:30 p.m. PDT the same day.

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Conference Call and Webcast Information

Protagonist executives will host a conference call at 4:30 p.m. EDT/1:30 p.m. PDT on Tuesday, March 10, 2020. To access the live call, dial 1-844-515-9178 (U.S./Canada) or 1-614-999-9313 (international) and refer to conference ID number 5591627. A live and archived webcast of the call will also be accessible in the Investors section of the Company’s website at www.protagonist-inc.com. A replay will be available on the company’s website approximately two hours after the call and will remain available for 60 days.