On October 21, 2019 Rheos Medicines, a biopharmaceutical company harnessing insights in immunometabolism to create a new class of therapeutics for patients with severe autoimmune disorders, inflammatory diseases and cancer, reported the appointment of industry veteran Barbara S. Fox, Ph.D., to Chief Executive Officer (Press release, Rheos Medicines, OCT 21, 2019, View Source [SID1234542393]). Dr. Fox succeeds interim Chief Executive Officer, Abbie Celniker, Ph.D., a partner at Third Rock Ventures, who will remain Chairman of Rheos Medicines’ board of directors.

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"Rheos’ scientific founders and passionate scientists are leaders in the field, and their groundwork has established an incredible foundation on which to build upon. I look forward to working with the Rheos team as we leverage the Company’s proprietary immunometabolism product engine to unlock a new frontier in drug discovery."

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"We are delighted to welcome Barbara to the team and believe her track record makes her an ideal fit as Rheos Medicines’ Chief Executive Officer," said Dr. Celniker. "We are confident that Barbara’s expertise in building and leading organizations will be an indispensable asset for Rheos and will propel the Company as it develops precision medicines for autoimmunity and other immune-mediated diseases."

Dr. Fox brings more than 25 years of biopharmaceutical leadership expertise to Rheos Medicines. She joins the Company from Tilos Therapeutics, a Lexington, MA-based biotech company developing antibody-based therapies for oncology and immune-mediated diseases. Dr. Fox served as Chief Executive Officer at Tilos and led the successful acquisition of the company by Merck in June of this year. Previous positions include Entrepreneur-in-Residence at Partners Innovation Fund, Founder and Chief Executive Officer of Avaxia Biologics, Founder and Chief Scientific Officer of Recovery Pharmaceuticals, and VP, Discovery and Immunology at ImmuLogic Pharmaceutical Corp. Prior to ImmuLogic, Dr. Fox was an Associate Professor of Rheumatology at the University of Maryland School of Medicine. Dr. Fox received her A.B. in Chemistry from Bryn Mawr College, her Ph.D. in Chemistry from the Massachusetts Institute of Technology and trained as a post-doc in Cellular Immunology at the National Institutes of Health.

"Rheos Medicines is pioneering and industrializing the emerging field of immunometabolism, and I am thrilled to be joining at such a pivotal time in the Company’s evolution," said Dr. Fox. "Rheos’ scientific founders and passionate scientists are leaders in the field, and their groundwork has established an incredible foundation on which to build upon. I look forward to working with the Rheos team as we leverage the Company’s proprietary immunometabolism product engine to unlock a new frontier in drug discovery."

On October 21, 2019 Sophiris Bio Inc. (NASDAQ: SPHS) (the "Company" or "Sophiris"), a biopharmaceutical company studying topsalysin (PRX302), a first-in-class, pore-forming protein, in late-stage clinical trials for the treatment of patients with urological diseases, reported that following an End of Phase 2/ Pre-Phase 3 meeting with the United States Food and Drug Administration (FDA), there is agreement regarding the design of a single Phase 3 clinical trial to evaluate the potential of topsalysin as a targeted focal therapy to treat patients with intermediate risk localized prostate cancer (Press release, Sophiris Bio, OCT 21, 2019, View Source [SID1234542392]).

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The Phase 3 study design agreed upon with the FDA is consistent with the design previously agreed upon with the European Medicines Agency, as reported in June of this year. The study will enroll approximately 700 patients with a confirmed diagnosis of localized intermediate risk disease, to be equally randomized to receive a single administration of either topsalysin or placebo. The primary endpoint for the study will be the proportion of patients at 12 months who have failed treatment, defined as histological progression of disease, resulting in the need for alternative therapy, as assessed by an independent central adjudication panel. In addition, the FDA has indicated that in order to receive approval, Sophiris will evaluate all patients that progress to alternative treatments for an additional 12 months, for a total of 24 months of data, post the administration of study drug.

"The meeting with the FDA was positive, confirming the proposed Phase 3 study design is an acceptable approach to targeted focal therapy in the proposed patient population. The FDA’s request to provide data on patients progressing to alternative therapy for an additional 12 months – for a total of 24 months – will, we believe, strengthen the overall data package for approval, providing valuable information on the durability of response following targeted focal therapy with topsalysin," said Professor Hashim Ahmed, Faculty of Medicine Department of Surgery & Cancer, Chair in Urology, Imperial College of London & Imperial College Healthcare NHS Trust and a member of the Scientific Advisory Board at Sophiris.

"The meeting with the FDA was productive and it was clear that if the proposed study were positive and the safety profile were to continue as observed in clinical trials to date, a single study has the potential to provide the clinical data to support regulatory approval in both the US and Europe," said Professor Scott Eggener, Faculty of Surgery and Radiobiology University of Chicago Medicine and a member of the Scientific Advisory Board at Sophiris.

"Now that there is a clear and agreed upon regulatory pathway forward for localized prostate cancer, we can now focus on our plan to fund this study and the Company going forward," said Randall E. Woods, our president and chief executive officer. "With the uncertainty of the regulatory pathway removed, we are advancing our discussions with multiple parties capable of funding the continued development of topsalysin."

About Localized Prostate Cancer

Prostate cancer is the second most common form of cancer in men in the United States with an estimated 175,000 new cases in 2019. Approximately 77 percent of patients in the United States are diagnosed with localized disease. Research has shown that patients with early, localized disease have a low likelihood of the cancer spreading beyond the confines of the prostate; however, many men with clinically-significant localized disease choose to undergo radical treatment. Radical therapies include surgery to remove the entire prostate and/or radiation. Potential toxicities from radical treatments can be significant and permanent and include erectile dysfunction, urinary incontinence and rectal toxicity.

About Topsalysin

Topsalysin (PRX302), an innovative, "First-in-Class" transmembrane pore-forming protein, was genetically modified to be activated only by enzymatically-active PSA, which is produced in large quantities within the prostate of men with prostate cancer. The targeted focal treatment of prostate cancer is in line with current treatment trends for solid tumors such as breast and liver, where the goal is to remove the tumor and preserve as much of the organ and organ function as possible.

Topsalysin has the potential to provide a targeted focal therapy for the ablation of localized prostate cancer lesions while potentially avoiding many of the complications and side effects associated with whole gland radical treatments. The increasing use of multiparametric magnetic resonance imaging (mpMRI) and advances in software to co-register previously obtained mpMRI images with real-time three-dimensional ultrasound images enables urologists to more accurately locate tumors within the prostate when taking biopsies. This increases the accuracy with which men with clinically significant lesions are identified. It also enables the injection of an ablative agent, such as topsalysin, directly into previously identified clinically significant tumors located within the prostate.

On October 21, 2019 Bruker Corporation (Nasdaq: BRKR) reported it will report third quarter 2019 financial results on Thursday, October 31, 2019, after the market closes (Press release, Bruker, OCT 21, 2019, View Source [SID1234542391]). The Company will host a conference call and webcast at 4:30 p.m. Eastern Time to discuss the results and current business trends.

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To listen to the webcast, investors can go to View Source and click on the "Earnings Webcast" hyperlink in the "Latest Results" section. A slide presentation will be referenced during the webcast and will be posted to the company’s website shortly before the webcast begins.

Investors can also listen to the earnings webcast via telephone by dialing 1-888-437-2685 (U.S. toll free) or +1-412-317-6702 (international) and referencing "Bruker’s Third Quarter 2019 Earnings Conference Call".

Bruker is enabling investors to pre-register for the earnings conference call so that they can expedite their entry into the call and avoid the need to wait for a live operator. In order to pre-register for the call, investors can visit View Source and enter their contact information. Investors will then be issued a personalized phone number and PIN to dial into the live conference call. Individuals can pre-register any time prior to the start of the conference call on October 31.

A telephone replay of the conference call will be available by dialing 1-877-344-7529 (U.S. toll free) or +1-412-317-0088 (international) and entering conference number: 10136323. The replay will be available beginning one hour after the end of the conference call through December 1, 2019.

On October 21, 2019 BIOLASE, Inc. (NASDAQ: BIOL), the global leader in dental lasers, reported select unaudited preliminary financial results for the third quarter ended September 30, 2019 (Press release, Biolase Technology, OCT 21, 2019, View Source [SID1234542390]).

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Select Preliminary Third Quarter 2019 Unaudited Financial Results:

Revenue is expected to be in the range of $8.5 million to $8.8 million.
Loss from operations is expected to be in the range of ($4.8) million to ($5.2) million as the Company increased its allowance for doubtful accounts by approximately $1.1 million to fully reserve for payments still owed to it by its Chinese distributor.
Net loss is expected to be in the range of ($5.4) million to ($5.8) million.
Third quarter adjusted EBITDA is anticipated to be in the range of ($2.7) million to ($3.1) million. The Company continues to expect to be adjusted EBITDA break-even in the fourth quarter of 2019, which is historically the Company’s strongest quarter.
Estimates of financial results are inherently uncertain and subject to change, and actual results may differ materially due to the completion of management’s final review, final adjustments and other developments that may arise before the Company’s financial results for the quarter ended September 30, 2019 are finalized.

Non-GAAP Disclosure

In addition to the financial information prepared in conformity with generally accepted accounting principles in the U.S. ("GAAP"), this press release includes certain historical non-GAAP financial information. Management believes that these non-GAAP financial measures assist investors in making comparisons of period-to-period operating results and that, in some respects, these non-GAAP financial measures are more indicative of the Company’s ongoing core operating performance than their GAAP equivalents.

Adjusted EBITDA is defined as net loss before interest, taxes, depreciation and amortization, stock-based compensation and allowance for doubtful accounts. Management uses adjusted EBITDA in its evaluation of the Company’s core results of operations and trends between fiscal periods and believes that these measures are important components of its internal performance measurement process. Therefore, investors should consider non-GAAP financial measures in addition to, and not as a substitute for, or as superior to, measures of financial performance prepared in accordance with GAAP. Further, the non-GAAP financial measures presented by the Company may be different from similarly named non-GAAP financial measures used by other companies.

The Company’s outlook for fourth quarter of 2019 earnings is provided on a non-GAAP basis because certain reconciling items are dependent on future events that either cannot be controlled, such as interest rates, or reliably predicted, such as stock-based compensation. Any such reconciling items may be significant.

Conference Call Information
BIOLASE, Inc. will host a conference call on November 6, 2019 at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss its financial results for the third quarter ended September 30, 2019, and to answer questions. For both "listen-only" participants and those participants who wish to take part in the question-and-answer portion of the call, the dial-in number in the U.S./Canada is 800-458-4148. For international participants outside the U.S./Canada, the dial-in number is 323-794-2093. For all callers, refer to the Conference ID 9068935. To access the live webcast, visit the Investor Relations section of the BIOLASE website at www.biolase.com and see "Investor Events".

An audio archive of the webcast will be available for 30 days on the Investor Relations section of the BIOLASE website.

On October 21, 2019 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 the completion of enrollment in CONTESSA, a multinational, multicenter, randomized, Phase 3 study investigating tesetaxel as a potential treatment for patients with HER2 negative, hormone receptor positive metastatic breast cancer (Press release, Odonate Therapeutics, OCT 21, 2019, View Source;a-phase-3-study-of-tesetaxel-in-patients-with-metastatic-breast-cancer-4b01a676-a578-4c38-a3a8-f70cc4daa7aa [SID1234542388]). The Company expects to report top-line results from CONTESSA in the third quarter of 2020.

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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). CONTESSA’s 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.