1stOncology™: Cancer Intelligence Service – Page 13606 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

ORIC Pharmaceuticals Presents Preclinical Data on Glucocorticoid Receptor Antagonist and CD73 Inhibitor Programs at AACR-NCI-EORTC Annual Conference

On October 28, 2019 ORIC Pharmaceuticals, a privately held, clinical-stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported new preclinical data on its lead program ORIC-101 – a selective and potent glucocorticoid receptor (GR) antagonist in Phase 1b – and its CD73 inhibitor program – an orally bioavailable small molecule inhibitor of a key node in the adenosine pathway – at the AACR (Free AACR Whitepaper)-NCI-EORTC International Conference on Molecular Targets & Cancer Therapeutics in Boston, Massachusetts (Press release, ORIC Pharmaceuticals, OCT 28, 2019, https://www.prnewswire.com/news-releases/oric-pharmaceuticals-presents-preclinical-data-on-glucocorticoid-receptor-antagonist-and-cd73-inhibitor-programs-at-aacr-nci-eortc-annual-conference-300945867.html [SID1234549937]).

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!

Glucocorticoid Receptor Antagonist Program

The ORIC-101 preclinical data were presented in abstract LB-A10, "ORIC-101 Overcomes Glucocorticoid-Driven Resistance to Enzalutamide in Castration-Resistant Prostate Cancer."

The glucocorticoid receptor has been identified as a potential antiandrogen bypass mechanism in patients with castration-resistant prostate cancer; thus GR-targeted therapies may overcome this therapeutic resistance to restore or prolong antiandrogen sensitivity. The poster presentation showed that GR is widely expressed in prostate cancer cell lines, organoids, and tumor tissue, and that GR levels are upregulated upon enzalutamide treatment. The data demonstrated that glucocorticoids promote tumor cell growth, stimulate expression of androgen regulated genes, and drive resistance to enzalutamide. Importantly, these effects were completely reversed by ORIC-101, suggesting ORIC-101 overcomes GR-driven resistance to enzalutamide.

ORIC-101 is currently in a Phase 1b study in combination with nab-paclitaxel in patients with advanced solid tumors. ORIC also plans to initiate a second Phase 1b study of ORIC-101 in combination with enzalutamide in patients with metastatic prostate cancer in the fourth quarter of 2019.

CD73 Inhibitor Program

Preclinical data from ORIC’s second program were presented in abstract LB-A19, "Intratumoral Immunosuppression is Reversed by Blocking Adenosine Production with an Oral Inhibitor of CD73."

The poster presentation showed that CD73 can drive adenosine generation from adenosine monophosphate (AMP) in vitro, resulting in suppression of anti-CD3/CD28-induced T cell activation and proliferation. The findings indicated that a novel, orally bioavailable CD73 inhibitor was able to effectively inhibit AMP to adenosine conversion both in vitro and in vivo, while an anti-CD73 antibody had incomplete effects. Small molecule-based inhibition of CD73 also fully restored proliferation and cytokine production of AMP/adenosine-suppressed T cells. Based on these results, an orally bioavailable small molecule inhibitor of CD73 represents a potential therapeutic approach to reverse immunosuppression within the tumor microenvironment.

AcelRx to announce third quarter 2019 results and provide an update on the company’s business on Wednesday, November 6th, 2019

On October 28, 2019 AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company, reported that it will release third quarter financial results after market close on Wednesday, November 6, 2019 (Press release, AcelRx Pharmaceuticals, OCT 28, 2019, View Source [SID1234549936]). AcelRx management will host a live webcast and conference call at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) on November 6, 2019 to discuss the financial results and provide an update on the company’s business.

The webcast is accessible by visiting the Investors page of the company’s website at www.acelrx.com and clicking on the webcast link on the Investors home page. The webcast will be accompanied by a slide presentation. A webcast replay will be available on the AcelRx website for 90 days following the call by visiting the Investor page of the company’s website at www.acelrx.com.

Investors who wish to participate in the conference call may do so by dialing (866) 361-2335 for domestic callers, (855) 669-9657 for Canadian callers or (412) 902-4204 for international callers.

Synthetic Biologics to Report 2019 Third Quarter Operational Highlights and Financial Results on November 4, 2019

On October 28, 2019 Synthetic Biologics, Inc. (NYSE American: SYN), a diversified clinical-stage company leveraging the microbiome to develop therapeutics designed to prevent and treat gastrointestinal (GI) diseases in areas of high unmet need, reported that the Company intends to release its operational highlights and financial results for the quarter ended September 30, 2019 on Monday, November 4, 2019, and to host a conference call the same day at 4:30 p.m. ET (Press release, Synthetic Biologics, OCT 28, 2019, View Source [SID1234549935]). The dial-in information for the call is as follows:

U.S. (toll free): 1-888-347-5280
International: +1 412-902-4280

Participants are asked to dial in 15 minutes before the start of the call to register. The call will also be webcast over the Internet at View Source." target="_blank" title="View Source." rel="nofollow">View Source An archived replay of the call will be available for approximately ninety (90) days at the same URL, View Source beginning approximately one hour after the call’s conclusion.

Universal Health Services, Inc. to Present at the 2019 Wolfe Research Healthcare Conference

On October 28, 2019 Universal Health Services, Inc. (NYSE: UHS) reported that Steve Filton, Executive Vice President and Chief Financial Officer will present at the 2019 Wolfe Research Healthcare Conference in New York, New York on Wednesday, November 6, 2019 at 11:15am (ET) (Press release, Universal Health Services, OCT 28, 2019, View Source [SID1234549934]).

A live audio webcast of the presentation will be available on the Company’s website (www.uhsinc.com). For those unable to listen to the live webcast, replays of the presentation will be available on the Company’s website for 90 days following the conference.

Headquartered in King of Prussia, PA, UHS has more than 87,000 employees and through its subsidiaries operates 354 inpatient acute care hospitals and behavioral health facilities and 40 outpatient and other facilities located in 37 states, Washington, D.C., Puerto Rico and the United Kingdom. It acts as the advisor to Universal Health Realty Income Trust, a real estate investment trust (NYSE:UHT). For additional information on the Company, visit our web site: View Source

Medpace Holdings, Inc. Reports Third Quarter 2019 Results

On October 28, 2019 Medpace Holdings, Inc. (Nasdaq: MEDP) ("Medpace") reported financial results for the third quarter ended September 30, 2019 (Press release, Medpace, OCT 28, 2019, View Source [SID1234549933]).

"In the third quarter the business environment remained steady, and cancellations continued at normal levels"

Tweet this
"In the third quarter the business environment remained steady, and cancellations continued at normal levels," said August J. Troendle, President & Chief Executive Officer.

Third Quarter 2019 Financial Results

Revenue for the three months ended September 30, 2019 increased 20.6% to $216.2 million, compared to $179.3 million for the comparable prior-year period. On a constant currency organic basis, revenue for the third quarter of 2019 increased 21.0% compared to the third quarter of 2018.

Backlog as of September 30, 2019 grew 19.9% to $1.2 billion from $1.0 billion as of September 30, 2018. Net new business awards were $285.4 million, representing a net book-to-bill ratio of 1.32x for the third quarter of 2019, as compared to $227.6 million for the comparable prior-year period. The Company calculates the net book-to-bill ratio by dividing net new business awards by revenue.

For the third quarter of 2019, total direct costs were $152.1 million, compared to total direct costs of $124.0 million in the third quarter of 2018. Selling, general and administrative (SG&A) expenses were $29.1 million, compared to SG&A expenses of $18.6 million in the third quarter of 2018.

GAAP net income for the third quarter of 2019 was $24.0 million, or $0.63 per diluted share, versus GAAP net income of $19.3 million, or $0.52 per diluted share, for the third quarter of 2018. This resulted in a net income margin of 11.1% and 10.8% for the third quarter of 2019 and 2018, respectively.

EBITDA for the third quarter of 2019 decreased 6.4% to $34.8 million, or 16.1% of revenue, compared to $37.1 million, or 20.7% of revenue, for the comparable prior-year period. On a constant currency basis, EBITDA for the third quarter of 2019 decreased 8.0% from the third quarter of 2018.

Adjusted Net Income for the third quarter of 2019 increased 8.0% to $27.0 million compared to $25.0 million for the comparable prior-year period. Adjusted Net Income per diluted share for the third quarter of 2019 was $0.71, representing an increase of 6.0%, compared to Adjusted Net Income per diluted share of $0.67 for the comparable prior-year period.

A reconciliation of the Company’s non-GAAP financial measures, including EBITDA, EBITDA margin, Adjusted Net Income, and Adjusted Net Income per diluted share to the corresponding GAAP measures is provided below.

Balance Sheet and Liquidity

The Company’s Cash and cash equivalents were $79.3 million at September 30, 2019, and the Company generated $64.3 million in cash flow from operating activities during the third quarter of 2019.

Financial Guidance

The Company forecasts 2019 revenue in the range of $840.0 million to $860.0 million, representing growth of 19.2% to 22.1% over 2018 revenue of $704.6 million. GAAP net income for full year 2019 is forecasted in the range of $94.9 million to $99.7 million. Additionally, full year 2019 EBITDA is expected in the range of $144.0 million to $150.0 million.

Based on forecasted 2019 revenue of $840.0 million to $860.0 million and GAAP net income of $94.9 million to $99.7 million, diluted earnings per share (GAAP) is forecasted in the range of $2.51 to $2.64. Adjusted Net Income for 2019 is forecasted in the range of $107.2 million to $112.0 million, compared to Adjusted Net Income of $95.5 million for 2018. Furthermore, Adjusted Net Income per diluted share for 2019 is expected in the range of $2.85 to $2.97 per share.

Conference Call Details

Medpace will host a conference call at 9:00 a.m. ET, Tuesday, October 29, 2019, to discuss its third quarter 2019 results.

To participate in the conference call, dial 800-219-7113 (domestic) or 574-990-1030 (international) using the passcode 7668623.

To access the conference call via webcast, visit the "Investors" section of Medpace’s website at medpace.com. The webcast replay of the call will be available at the same site approximately one hour after the end of the call.

A supplemental slide presentation will also be available at the "Investors" section of Medpace’s website prior to the start of the call.

A recording of the call will be available at 12:00 p.m. ET on Tuesday, October 29, 2019 until 12:00 p.m. ET on Tuesday, November 12, 2019. To hear this recording, dial 855-859-2056 (domestic) or 404-537-3406 (international) using the passcode 7668623.