On October 3, 2019 HCP, Inc. (NYSE: HCP) reported its third quarter 2019 financial results after the close of trading on the New York Stock Exchange on Wednesday, October 30, 2019 (Press release, Healthcare Property Investors (HCP), OCT 3, 2019, https://www.prnewswire.com/news-releases/hcp-to-report-third-quarter-2019-financial-results-and-host-conference-callwebcast-300929066.html [SID1234540050]). HCP will host a conference call and webcast on Thursday, October 31, 2019, at 9:00 a.m. Pacific Time (12:00 p.m. Eastern Time) in order to review its financial performance and operating results for the third quarter ended September 30, 2019.

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The dial-in number for the conference call is (888) 317-6003 (U.S.) or (412) 317-6061 (international). The conference ID number is 2983226. You may also access the conference call via webcast at www.hcpi.com under Investor Relations. An archive of the webcast will be available on HCP’s website through October 31, 2020, and a telephonic replay can be accessed through November 15, 2019, by calling (877) 344-7529 (U.S.) or (412) 317-0088 (international) and entering conference ID number 10135160.

On October 3, 2019 The Janssen Pharmaceutical Companies of Johnson & Johnson reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for niraparib, an orally-administered poly ADP-ribose polymerase (PARP) inhibitor, for the treatment of patients with BRCA1/2 gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have received prior taxane chemotherapy and androgen receptor (AR)-targeted therapy (Press release, Johnson & Johnson, OCT 3, 2019, View Source [SID1234540049]). A Breakthrough Therapy Designation is granted to expedite the development and regulatory review of an investigational medicine that is intended to treat a serious or life-threatening condition.1 The criteria for Breakthrough Therapy Designation require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.1

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BRCA1/2 mutations are the most common DNA-repair gene defects (DRD) in patients with mCRPC.2 Patients with a DRD in BRCA1/2 are at an elevated risk for both prostate cancer occurrence and more aggressive disease.2

"Niraparib is a PARP inhibitor that we believe may help address an important unmet need for patients with metastatic castration-resistant prostate cancer who have mutations in DNA-repair genes," said Kiran Patel, M.D., Vice President, Clinical Development, Solid Tumors, Janssen Research & Development, LLC. "We are pleased with the FDA’s Breakthrough Therapy Designation as we continue the clinical development of niraparib, and we look forward to working with the agency in our continued focus and commitment to bring new advancements to patients diagnosed with prostate cancer."

The Breakthrough Therapy Designation is based on data from the GALAHAD study, a Phase 2, multicenter, open-label clinical trial evaluating the efficacy and safety of niraparib in the treatment of adult patients with mCRPC and DRD who had received treatment with next-generation androgen-receptor targeting therapies and docetaxel.3 Data from the Phase 2 GALAHAD study were recently presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2019 Annual Congress as a late-breaking abstract.

About Metastatic Castration-Resistant Prostate Cancer
Metastatic castration-resistant prostate cancer is a form of prostate cancer that has spread to other parts of the body and keeps growing even when the amount of testosterone in the body is reduced to very low levels.4,5 The most common metastatic sites are bones, followed by distant lymph nodes, liver and thorax.6 Prostate cancer is the second most common type of cancer in men worldwide.7 More than one million people around the world are diagnosed with prostate cancer each year.7,8

Other Ongoing Studies with Niraparib
Ongoing studies for niraparib include the Phase 3 MAGNITUDE study evaluating niraparib in combination with ZYTIGA (abiraterone acetate) and prednisone in adults with metastatic prostate cancer. The MAGNITUDE study is evaluating niraparib plus ZYTIGA and prednisone in a broader population than GALAHAD in patients with frontline mCRPC disease. In addition, QUEST, a Phase 1b/2 study of niraparib combination therapies for the treatment of mCRPC, is ongoing.

About Niraparib
Niraparib is an orally-administered selective PARP inhibitor that is currently being studied by Janssen for the treatment of patients with prostate cancer. In April 2016, Janssen entered a worldwide (except Japan) collaboration and license agreement with TESARO, Inc., for exclusive rights to niraparib in prostate cancer. In the U.S., niraparib is indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.9 Niraparib is currently marketed as ZEJULA by TESARO, an oncology-focused business within GSK, devoted to providing transformative therapies to people facing cancer. Please refer to the full Prescribing Information available at View Source

On October 3, 2019 AMN Healthcare Services, Inc. (NYSE: AMN), healthcare’s leader and innovator in workforce solutions and staffing services, reported that it has scheduled a conference call to discuss its third quarter 2019 financial results on Thursday, October 31, 2019 at 5:00 p.m. Eastern Time (Press release, AMN Healthcare Services, OCT 3, 2019, View Source [SID1234540048]). The same day, the Company also expects to issue an earnings news release after market close at approximately 4:15 p.m. Eastern Time.

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A live webcast of the call can be accessed through AMN Healthcare’s website at View Source Please log in at least 10 minutes prior to the conference call in order to download the applicable audio software. Interested parties may participate live via telephone by dialing (800) 288-8960 in the U.S. or (612) 234-9960 for international callers. Following the conclusion of the call, a replay of the webcast will be available at the Company’s website. Alternatively, a telephonic replay of the call will be available beginning at 7:30 p.m. Eastern Time on October 31, 2019, and can be accessed until 11:59 p.m. Eastern Time on November 14, 2019 by calling (800) 475-6701 in the U.S. or (320) 365-3844 internationally, with access code 472944.

On October 3, 2019 Rafael Holdings, Inc., (NYSE American: RFL), reported revenue of $4.9 million and a loss per share of $0.35 for the fiscal year ended July 31, 2019 (Press release, Rafael Pharmaceuticals, OCT 3, 2019, View Source [SID1234540047]). Fourth quarter revenue was $1.4 million and the loss per share was $0.16.

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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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Recent Operational Highlights

Rafael Pharmaceuticals, a clinical-stage pharmaceutical company in which the Company holds preferred equity and a warrant to increase ownership to 56% of the fully diluted equity interests, reached an out-licensing agreement with Ono Pharmaceutical Co., Ltd. of Japan. Ono gained exclusive rights to develop and commercialize Rafael Pharma’s lead drug candidate, CPI-613 (devimistat) and related compounds for all indications in certain Asia-Pacific region countries. Rafael Pharma received an upfront payment of $12.9 million, with the right to an additional $150.3 million contingent on attainment of certain developmental and commercial milestones. Rafael Pharma will also receive low-double digit royalties based on net sales.
Rafael Pharma continued to expand its pivotal Phase 3 trial of CPI-613 (devimistat) for patients with relapsed or refractory acute myeloid leukemia (AML) adding clinical trial sites in France, Austria, South Korea and Spain.
Rafael Pharma continued to expand its pivotal Phase 3 trial of CPI-613 (devimistat) in combination with modified FOLFIRINOX as a first-line treatment for patients with metastatic pancreatic cancer adding clinical trial sites in France, Korea and Israel.
Future Oncology, a peer-reviewed medical journal, published two manuscripts about the details of ongoing Phase 2 and Phase 3 studies at Rafael Pharma.
LipoMedix Pharmaceuticals, a clinical-stage company in which we hold a majority interest, was awarded a Horizon 2020 Phase 1 grant for the project: Promitil – a new ‘smart’ nanomedicine for cancer chemo-radiotherapy. Horizon 2020 is a research and innovation program of the European Union.
Remarks by Howard Jonas, Chairman and CEO of Rafael Holdings
"During the fourth quarter, our key pharma holding, Rafael Pharma, continued to advance its clinical development programs, including pivotal, multi-jurisdictional, Phase 3 trials of CPI-613 (devimistat). Rafael Pharma also reached an out-licensing agreement with Ono Pharmaceuticals reflecting the promise of Rafael Pharma’s lead drug candidate.

"In addition, we have established a wholly-owned venture to develop a pipeline of therapeutic compounds including compounds to regulate cancer metabolism. The venture is pursuing collaborative research agreements with scientists from top academic institutions.

"We also continue our efforts to realize the value of our real estate holdings including our 20-story commercial property and associated garage in Newark, New Jersey."

On October 3, 2019 Heron Therapeutics, Inc. ("Heron") (NASDAQ: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, reported the pricing of an underwritten public offering of 8,571,429 shares of its common stock at a price of $17.50 per share (Press release, Heron Therapeutics, OCT 3, 2019, View Source [SID1234540046]). In addition, Heron has granted the underwriters of the offering a 30-day option to purchase up to an additional 1,285,714 shares of its common stock on the same terms and conditions. The offering is expected to close on or about October 8, 2019, subject to customary closing conditions.

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The gross proceeds from the offering are expected to be approximately $150 million before deducting customary underwriting discounts and offering expenses. Heron intends to use the proceeds from the proposed sale of its shares of common stock for the commercial launch of HTX-011, if approved by the U.S. Food and Drug Administration, the continued commercialization and marketing of SUSTOL and CINVANTI, Heron’s ongoing and future clinical trials, including further clinical studies for HTX-011, preclinical development work, other product development activities and general corporate purposes.

Jefferies, Cowen and Evercore ISI are acting as joint book-running managers for the offering. Cantor is acting as lead manager for the offering, and JMP Securities, Needham & Company and Northland Capital Markets are acting as co-managers for the offering.

The offering is being made pursuant to a registration statement that was filed with the U.S. Securities and Exchange Commission (the "SEC") and became automatically effective on July 6, 2017. A final prospectus supplement relating to and describing the terms of the offering will be filed with the SEC. The securities described above have not been qualified under any state blue sky laws. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. Copies of the final prospectus supplement (when available) and accompanying prospectus relating to these securities may also be obtained by sending a request to Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022, by telephone at (877) 821-7388, or by email at [email protected], Cowen and Company, LLC c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, by email at [email protected] or by telephone at (833) 297-2926; or Evercore Group L.L.C. at Attention Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, NY 10055, by telephone at (888) 474-0200, or by email at [email protected].