OncBioMune Selects Theradex as CRO for Two Phase 2 Trials of ProscaVax for Prostate Cancer

On March 8, 2018 OncBioMune Pharmaceuticals, Inc. (OTCQB:OBMP) ("OncBioMune" or the "Company"), a clinical-stage biopharmaceutical company engaged in the development of a proprietary immunotherapy cancer vaccine technology and targeted cancer therapies, is pleased reported that the Company has selected Theradex as its contract research organization (CRO) for both the planned Phase 2 clinical trials evaluating the experimental immunotherapeutic vaccine ProscaVax for prostate cancer, one at Urology Centers of North Texas (UCNT) and the other at Harvard University teaching hospitals (Press release, Oncbiomune, MAR 8, 2018, View Source [SID1234525399]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Theradex served as the CRO for the successfully completed Phase 1a trial of ProscaVax hosted at the University of California San Diego Moores Cancer Center and the Veterans Hospital in La Jolla, California.
In the UCNT trial, ProscaVax, the Company’s lead drug candidate consisting of a combination of prostate cancer associated prostate specific antigen (PSA) with the biological adjuvants interleukin-2 (IL-2) and granulocyte-macrophage colony-stimulating factor (GM-CSF), will be evaluated in a similar patient population as the Phase 1a trial, hormone-naïve and hormone-independent recurrent prostate cancer patients with increasing PSA. The Phase 2 study at the University will be the first mid-stage trial of its type that the Company is aware of, with ProscaVax being administered as a front-line treatment for patients in "active surveillance," meaning they are in the early stage of disease, have received no treatment for their prostate cancer and are only working with their oncologist to monitoring the cancer for signs of progression.

"Experts in oncology and the clinical process, Theradex was invaluable to us in the initial trial of ProscaVax and we’re certain that their experience and guidance will again be of utmost importance in the planned mid-stage studies," commented Dr. Jonathan Head, Chief Executive Officer at OncBioMune. "What we are trying to achieve by addressing prostate cancer at the earliest stage and in the most advanced stage is critically important to improving patient care in a cancer with very limited options across the disease spectrum. We look forward to working with Theradex again and to getting these studies underway."

Sign up for OncBioMune email alerts at: View Source

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

Curis has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Curis, 2018, MAR 8, 2018, View Source [SID1234524535]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Aptose To Release Fourth Quarter and Year End December 31, 2017 Financial Results and Hold Conference Call on March 27, 2018

on March 8, 2018 Aptose Biosciences Inc. (NASDAQ:APTO) (TSX:APS), a clinical-stage biotechnology company developing first-in-class agents that target the dysregulated processes and signaling pathways of cancer cells and address unmet medical needs of patients with life-threatening hematologic cancers, reported its financial results for the quarter and year ended December 31, 2017, on Tuesday, March 27, 2018 after the close of the market (Press release, Aptose Biosciences, MAR 8, 2018, View Source;p=RssLanding&cat=news&id=2336995 [SID1234524536]). 

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!


Conference Call & Webcast:
Tuesday, March 27th @ 5:00pm Eastern Time
Toll-Free: (844) 882-7834
International: (574) 990-9707
Passcode: 8873259
Webcast: View Source

Replays available through April 3rd, 2018
Toll-Free: (855) 859 2056
Replay Passcode: 8873259

The live conference call can also be accessed through a link on the Investor Relations section of Aptose’s website at ir.aptose.com. Please log onto the webcast at least 10 minutes prior to the start of the call to ensure time for any software downloads that may be required. An archived version of the webcast along with a transcript will be available on the company’s website for 30 days.

The press release, the financial statements and the management’s discussion and analysis for the quarter ended and year ended December 31, 2017 will be available on SEDAR at www.sedar.com and EDGAR at www.sec.gov/edgar.shtml

INSYS Therapeutics Reports Fourth Quarter and Full Year 2017 Results

On March 8, 2018 INSYS Therapeutics, Inc. (NASDAQ:INSY), a leader in the development, manufacture and commercialization of pharmaceutical cannabinoids and spray technology, reported financial results for its fourth quarter and full year ended Dec. 31, 2017 (Press release, Insys Therapeutics, MAR 8, 2018, View Source;p=RssLanding&cat=news&id=2337183 [SID1234524561]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

OVERALL HIGHLIGHTS

Achieved gross revenue of $46.1 million, resulting in net revenue of $31.5 million.
Advanced product pipeline with total R&D investment of $16.4 million.
Completed pharmacokinetics (PK) study of naloxone nasal spray as investigational treatment of opioid overdose.
Completed FDA filing of NDA for buprenorphine sublingual spray as investigational treatment for moderate-to-severe acute pain.
Initiated Phase 2 clinical trial of cannabidiol (CBD) oral solution as investigational treatment for medically refractory childhood absence epilepsy.
Enrolled first patient in proof-of-concept study of epinephrine nasal spray as investigational treatment for anaphylaxis.
Received ‘Fast Track’ designation from FDA for CBD oral solution as investigational treatment for Prader-Willi syndrome.
Settled lawsuit with one major health insurer.
"Over the course of 2017, we implemented a series of significant changes that set the foundation for a new strategic direction for the company as a leader in pharmaceutical cannabinoids and spray technologies," said Saeed Motahari, president and chief executive officer of INSYS Therapeutics. "This foundation was built around new leadership and elevated capabilities at all levels of the organization, which has allowed us to aggressively reposition and advance our product pipeline. Most importantly, this foundation establishes an unwavering commitment to enhance the quality of life for underserved patient populations, and we look forward to finding solutions for a number of orphan diseases through our R&D programs."

Motahari continued, "In the fourth quarter, we continued our efforts to stabilize SUBSYS despite the declining market for TIRF medications by securing several managed care wins that went into effect in January 2018. We also continued our controlled rollout of SYNDROS during the period. As a result, we intend to achieve top-line stability in 2018 in parallel with our ongoing transformation of the company."

Motahari concluded, "We believe our R&D in both pharmaceutical cannabinoids and spray technology platforms will propel INSYS to a strong market position for the coming years."

Financial & Operating Highlights

Net revenue for the fourth quarter of 2017 was $31.5 million, compared to $54.9 million for the fourth quarter of 2016.
Gross margin was 85.4 percent for the fourth quarter of 2017, compared to 82.1 percent in the same period of 2016.
Sales and marketing investment was $7.1 million for the fourth quarter of 2017, compared to $13.5 million for the fourth quarter of 2016.
Research and development investment increased to $16.4 million for the fourth quarter of 2017, compared to $15.5 million for the same period in 2016.
General and administrative expense increased to $19.7 million for the fourth quarter of 2017 from $15.8 million for the fourth quarter of 2016.
Income tax expense was $26.8 million for the fourth quarter of 2017 and included a $7.5 million charge related to the change in tax code and $22.6 million of expense to fully reserve our deferred tax assets, compared to an expense of $0.3 million during the fourth quarter of 2016.
Net loss for the fourth quarter of 2017 was $47.0 million, or ($0.65) per basic and diluted share, compared to a net loss of $3.7 million, or ($0.05) per basic and diluted share, for the fourth quarter of 2016.
Adjusted EBITDA loss for the fourth quarter of 2017 was $11.5 million, compared to Adjusted EBITDA of $6.1 million in the prior-year quarter. The reconciliation of net income to Adjusted EBITDA is included at the end of this news release.
The company had $163.9 million in cash, cash equivalents, and short-term and long-term investments with no debt as of Dec. 31, 2017.

Webcast Information

A conference call is scheduled for 5:00 p.m. Eastern Standard Time on March 8, 2018, to discuss the financial and operational results for the fourth quarter of and full year 2017. Interested parties can listen to the call live via the company’s website, View Source, on the INVESTORS section Presentations & Events page; or by dialing 844-263-8304 (from inside the U.S.) or 213-358-0958 (from outside the U.S.). A webcasted replay of the call will be available on the site a few hours after the event.

Genomic Health Announces 2017 Fourth Quarter and Year-end Financial Results, Provides 2018 Financial Outlook

on March 8, 2018 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, reported that fourth quarter and year end 2017 financial results on Thursday, March 15, 2018. Karyopharm’s management team will host a conference call and audio webcast at 8:30 a.m. ET on Thursday, March 15, 2018 to discuss the financial results and recent business developments (Press release, Genomic Health, MAR 8, 2018, View Source [SID1234524631]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

To access the conference call, please dial (855) 437-4406 (local) or (484) 756-4292 (international) at least 10 minutes prior to the start time and refer to conference ID 1181109. A live audio webcast of the call will be available under "Events & Presentations" in the Investor section of the Company’s website, investors.karyopharm.com/events.cfm. An archived webcast will be available on the Company’s website approximately two hours after the event.