On February 6, 2020 Epic Sciences, Inc. reported it will present two abstracts at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium to be held in San Francisco, February 13-15, 2020 (Press release, Epic Sciences, FEB 6, 2020, View Source [SID1234553968]). The abstracts feature two analyses of the PROPHECY trial cohort. One abstract evaluates the androgen-receptor splice variant 7 (AR-V7) in CTCs as a predictor of resistance to anti-androgen therapy. The second abstract reports new data on CTC-based biomarkers of chromosomal instability and small-cell neuroendocrine transformation and their association to resistance to anti-androgen therapy.

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"This analysis of PROPHECY builds on previous evidence demonstrating AR-V7 as a predictive biomarker, reinforcing the clinical utility of AR-V7 to guide treatment decisions for patients with metastatic prostate cancer and improve patient outcomes," said Rick Wenstrup, MD, chief medical officer at Epic Sciences. "Further, the research also demonstrated that CTC phenotypes of both chromosomal instability and small-cell neuroendocrine identify AR-V7 negative patients who are resistant to anti-androgen therapy. We believe patient selection strategies based on CTC phenotypes to identify patients more or less likely to respond to the various drug classes in prostate cancer will help in optimizing drug sequencing and associated treatment outcomes for patients."

Epic demonstrated its expertise in the development of blood-based tests that predict therapy response with the launch of the Oncotype Dx© AR-V7 Nucleus Detect test, commercially available and reimbursed by Medicare. The test, which is offered in the U.S. through Epic’s partnership with Exact Sciences for patients with mCRPC, assists physicians in choosing between androgen receptor-directed therapies or taxane chemotherapy.

Following are the details for the two poster sessions:

Title: AR-V7 and prediction of benefit with taxane therapy: Final analysis of PROPHECY
First Author: Andrew Armstrong, MD
Date and Time: Thursday, February 13, 2020 11:30 AM-1:00 PM and 5:30 PM-6:30 PM
Poster Session: A
Abstract: 184
Poster Board: H20

Title: Association of circulating tumor cell chromosomal instability with worse outcomes in men with mCRPC treated with abiraterone or enzalutamide
First Author: Landon Brown, MD
Date and Time: Thursday, February 13, 2020 11:30 AM-1:00 PM and 5:30 PM-6:30 PM
Poster Session: A
Abstract: 183
Poster Board: BOARD H19

On February 6, 2020 Aethlon Medical, Inc. (Nasdaq: AEMD), a medical device technology company focused on unmet needs in global health, reported that it will issue financial results for its third quarter fiscal year 2020, ended December 31, 2019, at 4:15pm Eastern time on Monday, February 10, 2020 (Press release, Aethlon Medical, FEB 6, 2020, https://www.prnewswire.com/news-releases/aethlon-medical-to-release-third-quarter-financial-results-and-host-conference-call-on-february-10-2020-301000019.html [SID1234553967]).

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Management will host a conference call on Monday, February 10, 2020 at 4:30pm eastern time to review financial results and recent corporate developments. Following management’s formal remarks, there will be a question and answer session.

To listen to the call by phone, interested parties within the U.S. should call 1-844-836-8741 and International callers should call 1-412-317-5442. All callers should ask for the Aethlon Medical, Inc. conference call.

A replay of the call will be available approximately one hour after the end of the call through February 17, 2020. The replay can be accessed via Aethlon Medical’s website or by dialing 1-877-344-7529 (domestic) or 1-412-317-0088 (international) or Canada Toll Free at 1-855-669-9658. The replay conference ID number is 10139278.

On February 6, 2020 Alkermes plc (Nasdaq: ALKS) will host a conference call and webcast presentation at 8:00 a.m. ET (1:00 p.m. GMT) on Thursday, Feb. 13, 2020, to discuss the company’s fourth quarter and year-end 2019 financial results (Press release, Alkermes, FEB 6, 2020, https://www.prnewswire.com/news-releases/alkermes-to-host-conference-call-to-discuss-fourth-quarter-and-year-end-2019-financial-results-301000560.html [SID1234553966]). Management will also discuss financial expectations for 2020 and provide an update on the company.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The webcast player and accompanying slides may be accessed on the Investors section of Alkermes’ website at www.alkermes.com. The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers.

A replay of the conference call will be available from 11:00 a.m. ET (4:00 p.m. GMT) on Thursday, Feb. 13, 2020, through Thursday, Feb. 20, 2020, and may be accessed by visiting Alkermes’ website or by dialing +1 877 660 6853 for U.S. callers and +1 201 612 7415 for international callers. The replay access code is 13698323.

On February 6, 2020 MEI Pharma, Inc. (NASDAQ: MEIP) ("MEI"), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported results for its second quarter ended December 31, 2019 (Press release, MEI Pharma, FEB 6, 2020, View Source [SID1234553965]).

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"We’re off to a good start in calendar year 2020. Our pipeline of clinical oncology candidates continues to advance, and the successful equity offering this past December gives us added resources to execute on our clinical strategy through key value-creating inflection points," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "We have several important milestones across our pipeline in 2020 including completing enrollment in the ME-401 TIDAL study, data updates from the Phase 1b study of ME-401 administered as a monotherapy and in combination with other agents to treat patients with B-cell malignancies, one year survival data from the Phase 2 pracinostat study in patients with MDS, and voruciclib updates in patients with AML and B-cell malignancies."

Dr. Gold added, "We remain very encouraged by the ME-401 clinical program; the maturing data on the intermittent dosing schedule in the Phase 1b study continue to demonstrate high overall response rates and durable responses, and the intermittent schedule also continues to be well tolerated. Based on the strength of the data set from these intermittent schedule patients, the TIDAL study was amended to consolidate the remaining study enrollment into the intermittent dosing arm. We expect to complete enrollment in the TIDAL study this summer and plan a submission for accelerated approval with the FDA based on the results of this study."

Recent Highlights

In December 2019, the Company completed a public offering of common stock resulting in net proceeds to the Company of approximately $48.5 million.
In December 2019, the Company amended the study protocol for TIDAL (Trials of PI3K DeltA in Non-Hodgkin’s Lymphoma), the Phase 2 trial evaluating ME-401 in patients with relapsed or refractory follicular lymphoma ("FL"). TIDAL is intended to support an accelerated approval marketing application with the FDA.
The amendment consolidates the remaining enrollment into the dosing arm in which patients receive ME-401 administered on the intermittent schedule ("IS").
The amendment was prompted by maturing data from the Phase 1b trial of ME-401 demonstrating that the IS regimen is as active as the continuous daily dosing regimen, is associated with durable responses to date, and is also associated with improved tolerability.
Approximately 120 patients will be enrolled in the IS arm and completion of enrollment is expected to complete in the summer of 2020.
In October 2019, the Company reported updated data from the ongoing Phase 1b study of ME-401, an investigational selective oral inhibitor of phosphatidylinositol 3-kinase ("PI3K") delta. The data demonstrate:
Overall response rates of 78% in relapsed or refractory FL and 89% in r/r chronic lymphocytic leukemia or small lymphocytic lymphoma ("CLL/SLL").
Rates of Grade 3 adverse events of special interest related to ME-401 exposure were observed in <10% of patients dosed on an IS.
Median duration of response was not reached in patients with FL or CLL/SLL on the IS regimen. Median follow-up for FL and CLL/SLL patients was 9.2 months (range 3.4-20.7 months) and 7.4 months (range 2.6-14.7 months), respectively.
Fiscal Second-Quarter Fiscal Year 2020 Financial Results

As of December 31, 2019, MEI had $103.9 million in cash, cash equivalents and short-term investments, with no outstanding debt.
For the quarter ended December 31, 2019, cash used in operations was $10.5 million, compared to $7.2 million for 2018.
Research and development expenses were $8.3 million for the quarter ended December 31, 2019, compared to $9.1 million for 2018. The decrease was primarily related to decreased drug manufacturing costs associated with ME-401.
General and administrative expenses were $4.2 million for the quarter ended December 31, 2019, compared to $3.8 million for 2018. The increase primarily relates to increased headcount and increased professional services expenses to support our activities.
Revenue was $1.0 million for the quarter ended December 31, 2019, compared to revenue of $2.0 million for the quarter ended December 31, 2018. Revenue resulted from the recognition of fees allocated to research and development activities related to the Helsinn and Kyowa Kirin License Agreements. During the quarter ended December 31, 2018, revenue also included $0.9 million from transfer of the license to Kyowa Kirin.
Net loss was $20.2 million, or $0.26 per share, for the quarter ended December 31, 2019, compared to net income of $12.0 million, or $0.17 per share for 2018. Net loss increased primarily as a result of a non-cash expense in the current quarter and a non-cash gain in the prior quarter related to changes in the fair value of the warrant liability associated with the May 2018 financing. The Company had 105,998,677 shares of common stock outstanding as of December 31, 2019, compared with 71,131,486 shares as of December 31, 2018.
The adjusted net loss for the quarter ended December 31, 2019, excluding a non-cash expense related to changes in the fair value of the warrants (a non-GAAP measure), was $11.8 million, compared to an adjusted net loss of $11.4 million for 2018.

On February 6, 2020 Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, reported that it will host a live conference call and webcast at 8:30 a.m. ET on Thursday, February 13, 2020 to report its fourth quarter and full year 2019 financial results and provide a corporate update (Press release, Blueprint Medicines, FEB 6, 2020, View Source [SID1234553964]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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To access the live conference call, please dial (855) 728-4793 (domestic) or (503) 343-6666 (international), and refer to conference ID 1240499. A webcast of the call will also be available under "Events and Presentations" in the Investors & Media section of the Blueprint Medicines website at View Source The archived webcast will be available on Blueprint Medicines’ website approximately two hours after the conference call and will be available for 30 days following the call.