On June 18, 2019 Prelude Corporation (PreludeDx), a leader in molecular diagnostics and personalized medicine for early stage breast cancer, reported its compelling data from research on stage 1 breast cancer patients presented at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL (Press release, Prelude Therapeutics, JUN 18, 2019, View Source [SID1234537150]). The abstract titled "Risk stratification in early stage luminal breast cancer patients treated with and without RT" shows that PreludeDx’s newly-developed assay can stratify risk of local recurrence in luminal stage 1 breast cancer patients.

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The study data shared by Dr. Troy Bremer, Chief Scientific Officer of PreludeDx, builds on work presented in December 2018 at SABCS. Results of the study demonstrated that the new test was able to stratify patients where those in the low risk group had a 4% local 10-yr risk of either invasive breast cancer or DCIS with surgery alone and 3% risk of local recurrence with surgery and radiation therapy. Patients in the elevated risk group had a 15% local recurrence risk when treated with surgery alone but, after radiation therapy, had their local recurrence risk reduced to 3% at 10 years.

According to Rakesh Patel, MD, a leading breast cancer radiation oncologist and Medical Director of Breast Cancer Services at Good Samaritan Hospital in Los Gatos, CA, "These findings are important as the patient population (stage 1 luminal breast cancer patients over 50 years old) represents a large share of the patients that we see in clinic and we currently have very little data guiding us on which patients would truly benefit from conventional adjuvant radiation therapy or as importantly, if radiation can be more limited or deferred altogether. Specifically, randomized data have yet to identify patients that do not at least statistically benefit from treatment after a lumpectomy; however, we know that the degree of benefit may not be clinically significant in some patients. Likewise, there are traditionally ‘low risk’ patient populations that have an elevated risk of developing breast cancer and should be considered for additional treatment, such as radiation therapy, tamoxifen or even chemotherapy. The PreludeDx test can help us resolve these cases and in turn allow us to tailor treatments to the patients biologic risk profile addressing the concern of both over and under treatment."

"Our focus is on developing new technologies that improve the lives of patients with early breast cancer, and the data presented at ASCO (Free ASCO Whitepaper) is a great example of how we plan to continue to innovate in this space," said Daniel Forche, PreludeDx President and CEO. He continued by saying, "We believe it is critically important to offer new radiogenomic tools to radiation oncologists so that they can deliver precision medicine to their patients in an environment where they have an ever-increasing armament of therapies at their disposal. We look forward to results of future validations and ultimately getting this new radiogenomic technology into the hands of radiation oncologists."

About DCISionRT for Breast DCIS
DCISionRT is the only radiogenomic risk assessment test for patients with ductal carcinoma in situ (DCIS), which affects over 60,000 women in the US each year. The test was developed by PreludeDx and built on research that began with funding from the National Cancer Institute to better understand the biology of DCIS. DCISionRT assesses a woman’s individual tumor biology and other risk factors to provide a personalized Decision Score that identifies a woman’s risk as low or elevated. DCISionRT’s intelligent reporting provides a woman’s recurrence risk after breast conserving surgery alone and with the addition of radiation therapy, effectively allowing patients and their physicians to make more informed treatment decisions.

On June 18, 2019 Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA), reported that it will deliver a corporate presentation at the JMP Securities Life Sciences Conference in New York City on Wednesday, June 19, 2019 at 2:00 p.m. Eastern Time (Press release, Vanda Pharmaceuticals, JUN 18, 2019, View Source [SID1234537149]).

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The corporate presentation at the JMP Securities Life Sciences Conference will be available live on Vanda’s corporate website, where it also will be archived for 30 days. To access the presentation, go to Vanda’s website at www.vandapharma.com and click on the Presentations tab on the Investor Relations page. Please connect to the website several minutes prior to the start of the live presentation.

On June 18, 2019 EXUMA Biotechnology, a clinical-stage biotechnology company discovering and developing CAR-T products for solid tumors and affiliate of F1 Oncology, Inc., reported the expansion of its leadership team with the appointment of Wendy Li, M.D. as Chief Medical Officer and James Samuels as Chief Financial Officer (Press release, EXUMA Biotechnology, JUN 18, 2019, View Source [SID1234537147]).

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"It’s been a successful quarter for EXUMA with the positive announcement of interim results from two first-in-human solid tumor CAR-T products," said Gregory Frost, Ph.D., Chairman of EXUMA. "It is my pleasure to welcome Dr. Li and James to the team; their expertise and broad experience will play a valuable role as EXUMA continues on its trajectory."

Dr. Li has more than 20 years of medical and scientific leadership in oncology research and other therapeutic areas, as well as clinical practice experience. Dr. Li brings her experience in oncology development from Genentech, Sanofi, and Pfizer, as well as from her former position as Vice President of Clinical Development and CMO at Sihuan Pharma/Co-Xuanzhu Pharma, providing leadership on global early and late stage clinical studies, responding to FDA/CFDA and related agencies, and advising clinical, marketing, regulatory, and pharmacovigilance teams. Dr. Li received her M.D. from the Sun Yat-Sen University of Medical Studies in China.

"EXUMA Biotechnology has a meaningful pipeline of exciting clinical and preclinical cellular therapy candidates," said Dr. Li. "I look forward to bringing my clinical and research experience to the team and for the opportunity to develop life changing therapies for patients."

James Samuels has nearly 20 years of experience managing finance for both public and private companies. Most recently, he served as the CFO of Vetsource, a venture capital-backed provider of outsourced veterinary pharmacy services. Previously, he served as the CFO of Fusheng Industrial, a Taiwan based global manufacturer of industrial compressors. Additionally, he has held various CFO roles at Johnson & Johnson operating companies in Asia-Pacific in the areas of medical devices, diagnostics and pharmaceuticals. Prior to leaving Johnson & Johnson, Samuels served as CFO of Xian-Janssen, Johnson & Johnson’s pharmaceutical joint-venture in China. He holds an MBA from The Wharton School at the University of Pennsylvania.

"It’s a tremendous opportunity to be part of this talented team of individuals dedicated to finding treatments that will help patients across the world," said Samuels. "I look forward to helping EXUMA build on its success to date."

On June 18, 2019 Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported that it has filed a preliminary prospectus supplement (the "Canadian Supplement") to its Canadian short form base shelf prospectus dated March 6, 2019 (the "Base Prospectus") in connection with an offering of its common shares and pre-funded warrants to purchase its common shares (the "Offering") (Press release, Zymeworks, JUN 18, 2019, View Source [SID1234537146]). The Canadian Supplement was filed with the securities regulatory authorities in each of the provinces and territories of Canada. A preliminary prospectus supplement (the "U.S. Supplement," together with the Canadian Supplement, the "Supplements") was also filed with the U.S. Securities and Exchange Commission (the "SEC") as part of a registration statement on Form S-3, as amended, including a prospectus which became effective January 31, 2019 (the "Registration Statement"), pursuant to which the securities will be offered in the United States.

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The Company also expects to grant to the underwriters a 30-day over-allotment option to purchase up to an additional 15% of the number of common shares offered in the Offering. The Offering is expected to be priced in the context of the market, with the final terms of the Offering to be determined at the time of pricing. There can be no assurance as to whether or when the Offering may be completed, or as to the actual size or terms of the Offering. The closing of the Offering will be subject to customary closing conditions, including the listing of the common shares on the TSX and NYSE and any required approvals of each exchange. The pre-funded warrants will not be listed on the TSX or the NYSE.

The Offering is expected to raise total gross proceeds of approximately US$150.0 million, before deducting underwriting discounts and commissions and estimated offering expenses. The Company intends to use the net proceeds of the Offering (i) to accelerate and expand the global development of ZW25 both as a single agent and in combination with other anti-cancer agents in a variety of HER2-expressing tumors, including gastroesophageal, breast and other underserved cancers; (ii) to accelerate and expand the clinical development of ZW49; (iii) to advance other novel preclinical programs, including those involving non-HER2-expressing tumors; and (iv) for general corporate purposes.

J.P. Morgan Securities, LLC is acting as active book-running manager for the Offering. Wells Fargo Securities, LLC and Stifel, Nicolaus & Company, Incorporated are acting as passive book-running managers, Raymond James Ltd. is acting as co-lead manager and Ladenburg Thalmann & Co. Inc. is acting as co-manager.

The Supplements and the Registration Statement contain important detailed information about the Offering. A copy of the Canadian Supplement can be found on SEDAR at www.sedar.com and www.sec.gov, and a copy of the U.S. Supplement and the related Registration Statement can be found on EDGAR at www.sec.gov. Copies of the Supplements may also be obtained from J.P. Morgan Securities, LLC, Attention; Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204; Wells Fargo Securities, LLC, Attention; Equity Syndicate Department, 375 Park Avenue, New York, NY 10152, by telephone at (800) 326-5897, or by email at [email protected]; or Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720, or by email at [email protected]. Prospective investors should read the Supplements and the Registration Statement before making an investment decision.

This news release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any province, state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such province, state or jurisdiction.

On June 18, 2019 ArQule, Inc. (Nasdaq: ARQL) reported that Marc Schegerin, Chief Financial Officer and Head of Strategy, will present at the BMO Prescriptions for Success Healthcare Conference on June 25, 2019 at 8:00 a.m. ET at the The Mandarin Oriental New York, New York (Press release, ArQule, JUN 18, 2019, View Source [SID1234537145]).

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The live webcast of the presentation will be available via the "Investors & Media" section of ArQule’s website, www.arqule.com, under "Events & Presentations." A replay of the webcast will be available shortly after the conclusion of the presentation.