On February 20, 2020 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, provided a clinical programs update and reported financial results for the year ended December 31, 2019 (Press release, Synthetic Biologics, FEB 20, 2020, View Source [SID1234554579]).

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"2019 was a highly eventful period marked by significant progress as we continued to execute our strategy to advance and demonstrate the significant value of our portfolio of GI and microbiome-focused clinical programs," stated Steven A. Shallcross, Chief Executive and Financial Officer. "Following the announcement of our clinical trial collaboration with the Washington University School of Medicine in St. Louis ("Washington University") to advance SYN-004 in allogeneic hematopoietic cell transplant (HCT) patients, we held an extremely productive Type-C meeting with the U.S. Food and Drug Administration ("FDA") to finalize the clinical program parameters of a Phase 1b/2a clinical trial expected to begin next quarter. Allogeneic HCT recipients who receive broad-spectrum IV beta-lactam antibiotics at onset of fever following conditioning chemotherapy are at high risk for Clostridioides difficile infection (CDI), colonization by vancomycin-resistant Enterococci (VRE) and acute graft-versus-host-disease (aGVHD). We believe SYN-004’s unique mechanism of action designed to degrade IV beta-lactam antibiotics and prevent dysbiosis of the gut microbiome has the potential to significantly improve outcomes for patients who undergo allogeneic HCT, an area of significant unmet need."

Mr. Shallcross continued, "Enrollment in our investigator-sponsored Phase 2b clinical study for SYN-010 in breath-methane positive irritable bowel syndrome with constipation (IBS-C) patients remains ongoing. We anticipate a data readout sometime during the first half of 2020 which we believe will further fortify the established clinical data set for SYN-010 and support regulatory discussions to potentially simplify future registration studies. Preclinical activities and toxicology studies are ongoing and remain on track to support a near-term Investigational New Drug Application (IND) filing for our SYN-020 Intestinal Alkaline Phosphatase (IAP) program. We look forward to sharing important updates and progress for this and all our GI and microbiome-focused clinical programs."

Clinical Development and Operational Update

Received official meeting minutes from FDA following a Type-C meeting held on December 2, 2018 at the Company’s request to discuss the development of a Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic HCT recipients. Based on the final meeting minutes,
Enrollment is expected to begin during the second quarter of 2020 contingent upon approval of the clinical trial protocol by the Washington University School of Medicine’s Institutional Review Board (IRB) and the FDA,
The Phase 1b/2a clinical trial will comprise a single center, randomized, double-blind, placebo-controlled clinical trial of oral SYN-004 (ribaxamase) in up to 36 evaluable adult allogeneic HCT recipients,
The goal of this clinical trial is to evaluate the safety, tolerability and potential absorption into the systemic circulation (if any) of 150 mg oral SYN-004 (ribaxamase) administered to allogeneic HCT recipients who receive an IV beta-lactam antibiotic to treat fever,
Clinical trial participants will be enrolled into three sequential cohorts and administered a different study-assigned IV beta-lactam antibiotic. Eight participants in each cohort will receive SYN-004 (ribaxamase) and four will receive placebo,
Safety and pharmacokinetic data for each cohort will be reviewed by an independent Data and Safety Monitoring Committee, which will make a recommendation on whether to proceed to the next IV beta-lactam antibiotic;
Enrollment is ongoing in the Phase 2b investigator-sponsored clinical study of SYN-010 for the treatment of IBS-C
The Phase 2b clinical trial is being conducted by the Medically Associated Science and Technology (MAST) Program at Cedars-Sinai Medical Center and is a 12-week, placebo-controlled, double-blind, randomized clinical trial evaluating two dose strengths of oral SYN-010 (21 mg and 42 mg) in up to 150 patients diagnosed with IBS-C,
The primary objective for the study will be to determine the efficacy of SYN-010, measured as an improvement from baseline in the weekly average number of complete spontaneous bowel movements (CSBMs) during the 12-week treatment period for SYN-010 21 mg and 42 mg daily doses relative to placebo,
Secondary efficacy endpoints for both dose strengths of SYN-010 will measure changes from baseline in abdominal pain, bloating, stool frequency as well as the use of rescue medication relative to placebo,
A data readout is anticipated in 1H 2020,
Cedars-Sinai Medical Center and Synthetic Biologics are co-funding the study. The patent rights covering the use of SYN-010 are owned by Cedars-Sinai Medical Center and are exclusively licensed by Cedars-Sinai Medical Center to Synthetic Biologics;
Completed Pre-IND meeting with FDA to discuss advancement of SYN-020 (intestinal alkaline phosphatase) into clinical trials targeting areas of significant unmet medical need, including enterocolitis associated with radiation therapy for cancer
Anticipate filing a US IND in Q2 2020;
Continued to exercise prudent cash management and financial stewardship to maintain cash runway through at least the fourth quarter of 2020.
Year Ended December 31, 2019 Financial Results

General and administrative expenses decreased to $4.6 million for the year ended December 31, 2019, from $5.7 million for the year ended December 31, 2018. This decrease of 19% is due to decreased stock-based compensation expense related to forfeitures and decreased option grants, along with the reduction of investor relations, consulting, registration, and legal costs. The charge relating to stock-based compensation expense was $0.3 million for the year ended December 31, 2019, compared to $1.0 million for the year ended December 31, 2018.

Research and development expenses decreased to $11.1 million for the year ended December 31, 2019, from $11.8 million for the year ended December 31, 2018. This decrease of 6% is primarily the result of lower SYN-004 (ribaxamase) indirect program costs for the year ended December 31, 2019, including salary and related expense reductions resulting from the 2018 restructuring, and the fact that no clinical trial activity for SYN-004 (ribaxamase) was ongoing during the year ended December 31, 2019, offset by an increase in manufacturing and pre IND-enabling toxicology study costs for SYN-020. Research and development expenses also include a charge relating to non-cash stock-based compensation expense of $75,000 for the year ended December 31, 2019, compared to $1.1 million for the year ended December 31, 2018.

Total other income was $283,000 for the year ended December 31, 2019, compared to other income of $4.2 million for the year ended December 31, 2018. Total other income for the year ended December 31, 2019 is primarily comprised of interest income while total other income for the year ended December 31, 2018 is comprised of non-cash income of $4.1 million from the change in fair value of warrants. The decrease in the fair value of warrants was due to the decrease in our stock price from December 31, 2017 to December 31, 2018.

Cash and cash equivalents on December 31, 2019 were $15.0 million, a decrease of $13.9 million from December 31, 2018.

Conference Call

Synthetic Biologics will hold a conference call today, Thursday, February 20, 2020, at 4:30 p.m. (EST). The dial-in information for the call is as follows, U.S. toll free: 1-888-347-5280 or 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 archive of the call will be available for replay at the same URL, View Source, for 90 days after the call.

On February 20, 2020 Danaher Corporation (NYSE: DHR) reported that its Board of Directors has approved a regular quarterly cash dividend of $0.18 per share of its common stock, payable on April 24, 2020 to holders of record on March 27, 2020 (Press release, Danaher, FEB 20, 2020, View Source [SID1234554578]). In addition, Danaher announced today that its Board of Directors has approved a quarterly cash dividend of $11.875 per share of its 4.75% Series A Mandatory Convertible Preferred Stock, payable on April 15, 2020 to holders of record on March 31, 2020.

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On February 20, 2020 Select Medical Holdings Corporation ("Select Medical") (NYSE: SEM) reported results for its fourth quarter and year ended December 31, 2019 (Press release, Select Medical, FEB 20, 2020, View Source [SID1234554577]).

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For the fourth quarter ended December 31, 2019, net operating revenues increased 8.7% to $1,374.6 million, compared to $1,264.7 million for the same quarter, prior year. Income from operations increased 27.3% to $112.4 million for the fourth quarter ended December 31, 2019, compared to $88.3 million for the same quarter, prior year. Net income increased 46.9% to $43.7 million for the fourth quarter ended December 31, 2019, compared to $29.7 million for the same quarter, prior year. For the fourth quarter ended December 31, 2019, net income included pre-tax losses on early retirement of debt of $19.4 million. For the fourth quarter ended December 31, 2018, net income included pre-tax losses on early retirement of debt of $3.9 million. Adjusted EBITDA increased 16.9% to $171.9 million for the fourth quarter ended December 31, 2019, compared to $147.1 million for the same quarter, prior year. Earnings per common share increased to $0.24 on a fully diluted basis for the fourth quarter ended December 31, 2019, compared to $0.18 for the same quarter, prior year. Adjusted earnings per common share was $0.31 on a fully diluted basis for the fourth quarter ended December 31, 2019, compared to $0.20 for the same quarter, prior year. Adjusted earnings per common share excludes the losses on early retirement of debt and their related tax effects for both the fourth quarters ended December 31, 2019 and 2018. The definition of Adjusted EBITDA and a reconciliation of net income to Adjusted EBITDA are presented in table IX of this release. A reconciliation of earnings per common share to adjusted earnings per common share is presented in table X of this release.

For the year ended December 31, 2019, net operating revenues increased 7.3% to $5,453.9 million, compared to $5,081.3 million for the prior year. Income from operations increased 13.1% to $471.9 million for the year ended December 31, 2019, compared to $417.3 million for the prior year. Net income increased 13.6% to $201.0 million for the year ended December 31, 2019, compared to $176.9 million for the prior year. For the year ended December 31, 2019, net income included pre-tax losses on early retirement of debt of $38.1 million and a pre-tax gain on sale of businesses of $6.5 million. For the year ended December 31, 2018, net income included pre-tax losses on early retirement of debt of $14.2 million, pre-tax gains on sales of businesses of $9.0 million, and pre-tax U.S. HealthWorks acquisition costs of $2.9 million. Adjusted EBITDA increased 10.2% to $710.9 million for the year ended December 31, 2019, compared to $645.2 million for the prior year. Earnings per common share increased to $1.10 on a fully diluted basis for the year ended December 31, 2019, compared to $1.02 for the prior year. Adjusted earnings per common share was $1.24 on a fully diluted basis for the year ended December 31, 2019, compared to $1.03 for the prior year. Adjusted earnings per common share excludes the losses on early retirement of debt and related costs and gain on sale of businesses and their related tax effects for the year ended December 31, 2019. Adjusted earnings per common share excludes the losses on early retirement of debt, gains on sales of businesses, U.S. HealthWorks acquisition costs, and their related tax effects for the year ended December 31, 2018. The definition of Adjusted EBITDA and a reconciliation of net income to Adjusted EBITDA are presented in table IX of this release. A reconciliation of earnings per common share to adjusted earnings per common share is presented in table X of this release.

Company Overview

Select Medical is one of the largest operators of critical illness recovery hospitals, rehabilitation hospitals, outpatient rehabilitation clinics, and occupational health centers in the United States based on the number of facilities. Select Medical’s reportable segments include the critical illness recovery hospital segment, the rehabilitation hospital segment, the outpatient rehabilitation segment, and the Concentra segment. As of December 31, 2019, Select Medical operated 101 critical illness recovery hospitals in 28 states, 29 rehabilitation hospitals in 12 states, and 1,740 outpatient rehabilitation clinics in 37 states and the District of Columbia. Select Medical’s joint venture subsidiary Concentra operated 521 occupational health centers in 41 states. Concentra also provides contract services at employer worksites and Department of Veterans Affairs community-based outpatient clinics. At December 31, 2019, Select Medical had operations in 47 states and the District of Columbia. Information about Select Medical is available at www.selectmedical.com.

Critical Illness Recovery Hospital Segment

For the fourth quarter ended December 31, 2019, net operating revenues for the critical illness recovery hospital segment increased 6.7% to $454.9 million, compared to $426.3 million for the same quarter, prior year. Adjusted EBITDA for the critical illness recovery hospital segment increased 8.0% to $60.5 million for the fourth quarter ended December 31, 2019, compared to $56.0 million for the same quarter, prior year. The Adjusted EBITDA margin for the critical illness recovery hospital segment was 13.3% for the fourth quarter ended December 31, 2019, compared to 13.1% for the same quarter, prior year. Certain critical illness recovery hospital key statistics are presented in table VII of this release for both the fourth quarters ended December 31, 2019 and 2018.

For the year ended December 31, 2019, net operating revenues for the critical illness recovery hospital segment increased 4.7% to $1,836.5 million, compared to $1,753.6 million for the prior year. Adjusted EBITDA for the critical illness recovery hospital segment increased 4.9% to $254.9 million for the year ended December 31, 2019, compared to $243.0 million for the prior year. The Adjusted EBITDA margin for the critical illness recovery hospital segment was 13.9% for both the years ended December 31, 2019 and 2018. Certain critical illness recovery hospital key statistics are presented in table VIII of this release for both the years ended December 31, 2019 and 2018.

Rehabilitation Hospital Segment

For the fourth quarter ended December 31, 2019, net operating revenues for the rehabilitation hospital segment increased 20.9% to $182.7 million, compared to $151.1 million for the same quarter, prior year. Adjusted EBITDA for the rehabilitation hospital segment increased 51.4% to $43.3 million for the fourth quarter ended December 31, 2019, compared to $28.6 million for the same quarter, prior year. The Adjusted EBITDA margin for the rehabilitation hospital segment was 23.7% for the fourth quarter ended December 31, 2019, compared to 18.9% for the same quarter, prior year. For the fourth quarter ended December 31, 2018, the Adjusted EBITDA results for the rehabilitation hospital segment include start-up losses of approximately $0.9 million. Certain rehabilitation hospital key statistics are presented in table VII of this release for both the fourth quarters ended December 31, 2019 and 2018.

For the year ended December 31, 2019, net operating revenues for the rehabilitation hospital segment increased 14.9% to $671.0 million, compared to $583.7 million for the prior year. Adjusted EBITDA for the rehabilitation hospital segment increased 24.7% to $135.9 million for the year ended December 31, 2019, compared to $108.9 million for the prior year. The Adjusted EBITDA margin for the rehabilitation hospital segment was 20.2% for the year ended December 31, 2019, compared to 18.7% for the prior year. The Adjusted EBITDA results for the rehabilitation hospital segment include start-up losses of approximately $8.8 million for the year ended December 31, 2019, compared to approximately $4.7 million for the prior year. Certain rehabilitation hospital key statistics are presented in table VIII of this release for both the years ended December 31, 2019 and 2018.

Outpatient Rehabilitation Segment

For the fourth quarter ended December 31, 2019, net operating revenues for the outpatient rehabilitation segment increased 7.7% to $271.9 million, compared to $252.4 million for the same quarter, prior year. Adjusted EBITDA for the outpatient rehabilitation segment increased 14.9% to $40.2 million for the fourth quarter ended December 31, 2019, compared to $35.0 million for the same quarter, prior year. The Adjusted EBITDA margin for the outpatient rehabilitation segment was 14.8% for the fourth quarter ended December 31, 2019, compared to 13.9% for the same quarter, prior year. Certain outpatient rehabilitation key statistics are presented in table VII of this release for both the fourth quarters ended December 31, 2019 and 2018.

For the year ended December 31, 2019, net operating revenues for the outpatient rehabilitation segment increased 5.0% to $1,046.0 million, compared to $995.8 million for the prior year. Adjusted EBITDA for the outpatient rehabilitation segment increased 6.9% to $151.8 million for the year ended December 31, 2019, compared to $142.0 million for the prior year. The Adjusted EBITDA margin for the outpatient rehabilitation segment was 14.5% for the year ended December 31, 2019, compared to 14.3% for the prior year. Certain outpatient rehabilitation key statistics are presented in table VIII of this release for both the years ended December 31, 2019 and 2018.

Concentra Segment

The financial results for the Concentra segment include U.S. HealthWorks beginning February 1, 2018.

For the fourth quarter ended December 31, 2019, net operating revenues for the Concentra segment increased 3.4% to $397.1 million, compared to $384.3 million for the same quarter, prior year. Adjusted EBITDA for the Concentra segment increased 6.8% to $56.5 million for the fourth quarter ended December 31, 2019, compared to $52.9 million for the same quarter, prior year. The Adjusted EBITDA margin for the Concentra segment was 14.2% for the fourth quarter ended December 31, 2019, compared to 13.8% for the same quarter, prior year. Certain Concentra key statistics are presented in table VII of this release for both the fourth quarters ended December 31, 2019 and 2018.

For the year ended December 31, 2019, net operating revenues for the Concentra segment increased 4.6% to $1,628.8 million, compared to $1,557.7 million for the prior year. Adjusted EBITDA for the Concentra segment increased 9.7% to $276.5 million for the year ended December 31, 2019, compared to $252.0 million for the prior year. The Adjusted EBITDA margin for the Concentra segment was 17.0% for the year ended December 31, 2019, compared to 16.2% for the prior year. Certain Concentra key statistics are presented in table VIII of this release for both the years ended December 31, 2019 and 2018.

Stock Repurchase Program

The board of directors of Select Medical has authorized a common stock repurchase program to repurchase up to $500.0 million worth of shares of its common stock. The program has been extended until December 31, 2020, and will remain in effect until then, unless further extended or earlier terminated by the board of directors. Stock repurchases under this program may be made in the open market or through privately negotiated transactions, and at times and in such amounts as Select Medical deems appropriate. Select Medical funds this program with cash on hand and borrowings under its revolving credit facility.

During the year ended December 31, 2019, Select Medical repurchased 2,165,221 shares at a cost of approximately $33.2 million, or $15.32 per share, which includes transaction costs. Since the inception of the program through December 31, 2019, Select Medical has repurchased 38,089,349 shares at a cost of approximately $347.9 million, or $9.13 per share, which includes transaction costs.

Financing Transactions

On December 10, 2019, Select Medical issued and sold $675.0 million aggregate principal amount of 6.250% senior notes, due August 15, 2026, as additional notes under the indenture dated August 1, 2019, pursuant to which it previously issued $550.0 million of 6.250% senior notes due 2026. The additional senior notes were issued at 106.00% of the aggregate principal amount.

On December 10, 2019, Select Medical entered into Amendment No. 4 to its senior secured credit agreement. Among other things, Amendment No. 4 provided for an additional $615.0 million in term loans that, along with the existing term loans, have a maturity date of March 6, 2025.

Select Medical used a portion of the net proceeds from the incremental term loans, together with a portion of the net proceeds of the 6.250% additional senior notes, to make a first lien term loan in the aggregate principal amount of approximately $1,240.3 million to Concentra Inc., pursuant to an intercompany loan agreement. Concentra Inc. used the proceeds from the intercompany loan to repay in full the first lien term loan outstanding under Concentra Inc.’s first lien credit agreement. Concentra Inc. continues to have availability of up to $100.0 million under its existing revolving credit facility.

Purchase of Concentra Interest

On January 1, 2020, Select Medical, Welsh, Carson, Anderson & Stowe XII, L.P. ("WCAS"), and Dignity Health Holding Corporation ("DHHC") entered into an agreement pursuant to which Select Medical acquired approximately 17.2% of the outstanding membership interests of Concentra Group Holdings Parent, LLC ("Concentra Parent") on a fully diluted basis from WCAS, DHHC, and other equity holders of Concentra Parent for approximately $338.4 million. On February 1, 2020, Select Medical, WCAS and DHHC entered into an agreement pursuant to which Select Medical acquired an additional 1.4% of the outstanding membership interests of Concentra Parent on a fully diluted basis from WCAS, DHHC, and other equity holders of Concentra Parent for approximately $27.8 million.

These purchases were in lieu of, and considered to be, the exercise of the first put right provided to certain equity holders under the terms of the Amended and Restated Limited Liability Company Agreement of Concentra Parent, dated as of February 1, 2018. Following these purchases, Select Medical owns approximately 66.6% of the outstanding membership interests of Concentra Parent on a fully diluted basis and approximately 68.8% of the outstanding voting membership interests of Concentra Parent.

Business Outlook

Select Medical reaffirms its 2020 business outlook, provided most recently in its January 27, 2020 press release, for net operating revenues, Adjusted EBITDA and fully diluted earnings per common share. Select Medical continues to expect consolidated net operating revenues for the full year 2020 to be in the range of $5.575 billion to $5.675 billion. Select Medical continues to expect Adjusted EBITDA for the full year 2020 to be in the range of $725.0 million to $760.0 million. Select Medical continues to expect fully diluted earnings per common share for the full year 2020 to be in the range of $1.27 to $1.46.

Conference Call

Select Medical will host a conference call regarding its results for the fourth quarter and full year ended December 31, 2019, as well as its business outlook, on Friday, February 21, 2020, at 9:00am ET. The domestic dial in number for the call is 1-866-440-2669. The international dial in number is 1-409-220-9844. The conference ID for the call is 8644656. The conference call will be webcast simultaneously and can be accessed at Select Medical Holdings Corporation’s website www.selectmedicalholdings.com.

For those unable to participate in the conference call, a replay will be available until 12:00pm ET, February 28, 2020. The replay number is 1-855-859-2056 (domestic) or 1-404-537-3406 (international). The conference ID for the replay will be 8644656. The replay can also be accessed at Select Medical Holdings Corporation’s website, www.selectmedicalholdings.com.

On February 20, 2020 Physicians’ Education Resource (PER), a leading resource for continuing medical education (CME), reported that it will conduct six CME-accredited satellite symposia during the 37th Annual Miami Breast Cancer Conference at the Fontainebleau in Miami Beach, Florida, March 5-8 (Press release, Physicians’ Education Resource, FEB 20, 2020, View Source [SID1234554576]).

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"Our all-inclusive breast cancer conference is one of our biggest and most influential programs of the year," said Phil Talamo, president of PER. "This year we excited more than ever offering additional CME educational opportunities such as invaluable expert insights from world-renowned thought leaders, engaging symposia sessions and legendary medical crossfires. Join us in March, you won’t want to miss the 37th Annual Miami Breast Cancer Conference."

The PER satellite symposia are as follows:

Coffee Talk: Initiating Early Recognition and Intervention in a Rare Lymphoma Associated With Breast Implants, which will be held Thursday, March 5, from 9:15 to 10:45 a.m., in the meeting room Fontaine. The program will be chaired by Lloyd B. Gayle, M.D., FACS, chief of plastic surgery and vice chair of surgery, Maimonides Medical Center in Brooklyn, New York; and clinical associate professor of surgery, Weill Medical College of Cornell University in New York. To register, click here.
Managing Postoperative Pain: The Clinical Impact of Opioid-Sparing Strategies on Patients with Breast Cancer, which will be held Thursday, March 5, from 7 to 8:30 p.m., in the meeting room Fontaine. The program will be chaired by Patrick I. Borgen, M.D., chair of the department of surgery and director, breast cancer program, Maimonides Medical Center in Brooklyn, New York. To register, click here.
Coffee Talk: Perspectives on PARP, HER2/3, PI3K, and Emerging Oncogenic Targets in Breast Cancer Care, which will be held Friday, March 6, from 7 to 8:30 a.m., in the meeting room Fontaine. The program will be chaired by Mark E. Robson, M.D., chief, breast medicine service, and attending physician, breast medicine and clinical genetics services, Memorial Sloan Kettering Cancer Center; and professor of medicine, Weill Cornell Medical College in New York. To register, click here.
Leveraging Immunogenicity to Optimize Patient Outcomes in Triple Negative Breast Cancer: Current and Emerging Evidence, which will be held Friday, March 6, from 6:30 to 8:00 p.m., in the meeting room Fontaine. The program will be chaired by Joyce O’Shaughnessy, M.D., the Celebrating Women Chair in Breast Cancer Research, Texas Oncology-Baylor Charles A. Sammons Cancer Center; and chair, breast cancer research program, The US Oncology Network in Dallas, Texas. To register, click here.
Medical Crossfire: Real World Scenarios and Applications for Biosimilars in HER2-Positive Breast Cancer: Key Concepts for Clinical Decision-Making, which will be held Saturday, March 7, from 7 to 8:30 a.m., in the meeting room Fontaine. The program will be chaired by Hope S. Rugo, M.D., FASCO, professor of medicine, department of medicine (hematology/oncology), and director, breast oncology clinical trials program, University of California San Francisco Helen Diller Family Comprehensive Cancer Center in California. To register, click here.
How We Do it: Personalizing Treatment for Patients With HER2-Positive Breast Cancer, which will be held Sunday, March 8, from 7 to 8:30 a.m., in the meeting room Fontaine. The program will be chaired by Debu Tripathy, M.D., professor and chair, department of breast medical oncology, The University of Texas MD Anderson Cancer Center in Houston. To register, click here.
Each satellite is accredited by the Accreditation Council for Continuing Medical Education for 1.5 AMA PRA Category 1 Credits for physicians.

On February 20, 2020 Odonate Therapeutics, Inc. (NASDAQ: ODT), a pharmaceutical company dedicated to the development of best-in-class therapeutics that improve and extend the lives of patients with cancer, reported financial results for the three and twelve months ended December 31, 2019 (Press release, Odonate Therapeutics, FEB 20, 2020, View Source [SID1234554575]).

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As of December 31, 2019, Odonate had $180.5 million in cash, compared to $139.1 million as of December 31, 2018. This increase in cash resulted primarily from the receipt of $135.1 million of net proceeds from Odonate’s June 2019 underwritten public offering, less net cash used in operating activities of $96.6 million. Odonate’s net loss for the three and twelve months ended December 31, 2019 was $27.9 million and $111.8 million, or $0.91 and $4.05 per share, respectively, compared to $28.8 million and $89.0 million, or $1.17 and $3.64 per share, respectively, for the same periods in 2018.

"We are pleased to have recently announced the completion of enrollment in CONTESSA, Odonate’s Phase 3 study investigating tesetaxel as a potential treatment for patients with metastatic breast cancer," said Kevin Tang, Chief Executive Officer of Odonate. "We expect to report top-line results from CONTESSA in the third quarter of 2020."

About Tesetaxel

Tesetaxel is an investigational, orally administered chemotherapy agent that belongs to a class of drugs known as taxanes, which are widely used in the treatment of cancer. Tesetaxel has several pharmacologic properties that make it unique among taxanes, including: oral administration with a low pill burden; a long (~8-day) terminal plasma half-life in humans, enabling the maintenance of adequate drug levels with relatively infrequent dosing; no history of hypersensitivity (allergic) reactions; and significant activity against chemotherapy-resistant tumors. In patients with metastatic breast cancer, tesetaxel was shown to have significant, single-agent antitumor activity in two multicenter, Phase 2 studies. Tesetaxel currently is the subject of three studies in breast cancer, including a multinational, multicenter, randomized, Phase 3 study in patients with metastatic breast cancer, known as CONTESSA.

About CONTESSA

CONTESSA is a multinational, multicenter, randomized, Phase 3 study of tesetaxel, an investigational, orally administered taxane, in patients with metastatic breast cancer (MBC). CONTESSA is comparing tesetaxel dosed orally at 27 mg/m2 on the first day of each 21-day cycle plus a reduced dose of capecitabine (1,650 mg/m2/day dosed orally for 14 days of each 21-day cycle) to the approved dose of capecitabine alone (2,500 mg/m2/day dosed orally for 14 days of each 21-day cycle) in approximately 600 patients randomized 1:1 with human epidermal growth factor receptor 2 (HER2) negative, hormone receptor (HR) positive MBC previously treated with a taxane in the neoadjuvant or adjuvant setting. Capecitabine is an oral chemotherapy agent that is considered a standard-of-care treatment in MBC. Where indicated, patients must have received endocrine therapy with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor. Patients with central nervous system (CNS) metastases are eligible. The primary endpoint is progression-free survival (PFS) as assessed by an Independent Radiologic Review Committee (IRC). The secondary efficacy endpoints are overall survival (OS), objective response rate (ORR) as assessed by the IRC and disease control rate (DCR) as assessed by the IRC.

About CONTESSA 2

CONTESSA 2 is a multinational, multicenter, Phase 2 study of tesetaxel, an investigational, orally administered taxane, in patients with metastatic breast cancer (MBC). CONTESSA 2 is investigating tesetaxel dosed orally at 27 mg/m2 on the first day of each 21-day cycle plus a reduced dose of capecitabine (1,650 mg/m2/day dosed orally for 14 days of each 21-day cycle) in approximately 125 patients with human epidermal growth factor receptor 2 (HER2) negative, hormone receptor (HR) positive MBC not previously treated with a taxane. Capecitabine is an oral chemotherapy agent that is considered a standard-of-care treatment in MBC. Where indicated, patients must have received endocrine therapy with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor. Patients with central nervous system (CNS) metastases are eligible. The primary endpoint is objective response rate (ORR) as assessed by an Independent Radiologic Review Committee (IRC). The secondary efficacy endpoints are duration of response (DoR) as assessed by the IRC, progression-free survival (PFS) as assessed by the IRC, disease control rate (DCR) as assessed by the IRC and overall survival (OS).

About CONTESSA TRIO

CONTESSA TRIO is a multi-cohort, multicenter, Phase 2 study of tesetaxel, an investigational, orally administered taxane, in patients with metastatic breast cancer (MBC). In Cohort 1, approximately 90 patients (with potential expansion to up to 150 patients) with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior chemotherapy for advanced disease will be randomized 1:1:1 to receive tesetaxel dosed orally at 27 mg/m2 on the first day of each 21-day cycle plus either: (1) nivolumab at 360 mg by intravenous infusion on the first day of each 21-day cycle; (2) pembrolizumab at 200 mg by intravenous infusion on the first day of each 21-day cycle; or (3) atezolizumab at 1,200 mg by intravenous infusion on the first day of each 21-day cycle. Nivolumab and pembrolizumab (PD-1 inhibitors) and atezolizumab (a PD-L1 inhibitor) are immuno-oncology (IO) agents approved for the treatment of multiple types of cancer. One of these agents, atezolizumab, in combination with the intravenously delivered taxane, nab-paclitaxel, was recently approved by the U.S. Food and Drug Administration (FDA) as a first-line treatment for patients with metastatic TNBC. The dual primary endpoints for Cohort 1 are objective response rate (ORR) and progression-free survival (PFS). Secondary endpoints include duration of response (DoR) and overall survival (OS). Efficacy results for each of the three PD-(L)1 inhibitor combinations will be assessed for correlation with the results of each of the three approved PD-L1 diagnostic assays. In Cohort 2, approximately 40 elderly patients (with potential expansion to up to 60 patients) with human epidermal growth factor receptor 2 (HER2) negative MBC will receive tesetaxel monotherapy dosed orally at 27 mg/m2 on the first day of each 21-day cycle. The primary endpoint for Cohort 2 is ORR. Secondary endpoints include PFS, DoR and OS. Patients with central nervous system (CNS) metastases are eligible for both cohorts.