On February 6, 2020 Palatin Technologies, Inc. (NYSE American: PTN) reported that it will announce its second quarter fiscal year 2020 operating results on Tuesday, February 11, 2020 before the open of the U.S. financial markets (Press release, Palatin Technologies, FEB 6, 2020, View Source [SID1234553970]).

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Palatin will also conduct a conference call and live audio webcast hosted by its executive management team on February 11, 2020 at 11:00 a.m. ET. The conference call will include a review of the company’s operating results and an update on programs under development.

Schedule for the Operating Results Press Release, Conference Call / Audio Webcast

Q2 Fiscal Year 2020 Financial Results Press Release

2/11/2020 at 7:30 a.m. ET

Q2 Fiscal Year 2020 Conference Call-Live

2/11/2020 at 11:00 a.m. ET

US/Canada Dial-In Number:

1-800-353-6461

International Dial-In Number:

1-334-323-0501

Conference ID:

7551093

Q2 Fiscal Year 2020 Conference Call-Replay

2/11/2020-2/18/2020

US/Canada Dial-In Number:

1-888-203-1112

International Dial-In Number:

1-719-457-0820

Replay Passcode:

7551093

Audio Webcast Live and Replay Access

View Source

The audio webcast and replay can be accessed by logging on to the "Investors-Webcasts" section of Palatin’s website at View Source.

On February 6, 2020 Kleo Pharmaceuticals, Inc., an immuno-oncology company developing next-generation, fully synthetic bispecific compounds designed to emulate or enhance the activity of biologics, reported that it has received Investigational New Drug (IND) authorization to proceed from the U.S. Food and Drug Administration (FDA) to initiate a safety and tolerability clinical study combining KP1237, a CD38-targeting antibody recruiting molecule (ARM), with patients’ own Natural Killer (NK) cells to treat multiple myeloma (MM) in post-transplant patients (Press release, Kleo Pharmaceuticals, FEB 6, 2020, View Source [SID1234553969]).

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The single-arm study will be conducted in 25-30 patients with exploratory endpoints that assess the MRD (minimal residual disease) conversion rate at 90-100 days after transplantation. Recent clinical trials have identified MRD negativity post-transplant as a potential surrogate of long-term remission in MM. The trial is expected to begin enrollment in the first half of 2020, and topline data are expected in the second half of 2021.

"We are excited to have clearance to initiate a clinical trial in the US that addresses a significant unmet medical need in newly diagnosed, post-transplant multiple myeloma patients," said Kleo CEO Doug Manion, MD. "Approximately 30,000 individuals are diagnosed with multiple myeloma in the United States each year, with at least 1/3 of those patients undergoing autologous stem cell transplants."

In this trial, KP1237 is being investigated as a "cell homing" molecule to target the patient’s activated NK cells to the CD38-expressing tumor. Current anti-CD38 therapeutic antibodies kill NK cells and are not approved for use in this clinical settingi.

Nonclinical efficacy data presented at the 2019 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting demonstrated that CD38-ARMs are able to kill multiple myeloma cells by antibody-dependent cellular cytotoxicity without depleting CD38-expressing immune cells. Nonclinical data also demonstrated that the CD38-ARM molecule did not induce complement-dependent cytotoxicity (CDC) suggesting it is not likely to cause CDC in humans. Kleo’s 2019 ASH (Free ASH Whitepaper) posters can be viewed here and here.

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.