Aduro Biotech to Present at Two Upcoming Investor Conferences in March

On March 7, 2019 Aduro Biotech, Inc. (NASDAQ: ADRO) reported that Aduro management is scheduled to present at the following investor conferences (Press release, Aduro Biotech, MAR 7, 2019, View Source;p=RssLanding&cat=news&id=2390489 [SID1234534094]):

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39TH Annual Cowen Health Care Conference in Boston, Massachusetts on Wednesday, March 13TH at 8:00 am ET.
29TH Annual Oppenheimer Healthcare Conference in New York, New York on Tuesday, March 19TH at 10:55 am ET.
To access the live webcasts and subsequent archived recordings of these and other company presentations, please visit the investor section of Aduro’s website at www.aduro.com. The archived webcasts will remain available for replay on Aduro’s website for 30 days.

SURFACE ONCOLOGY REPORTS FINANCIAL RESULTS AND CORPORATE HIGHLIGHTS FOR FOURTH QUARTER AND FULL YEAR 2018

On March 7, 2019 Surface Oncology (NASDAQ:SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported financial results and corporate highlights for the fourth quarter and full year 2018, as well as anticipated corporate milestones for 2019 (Press release, Surface Oncology, MAR 7, 2019, View Source [SID1234534095]).

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"At Surface we strive to break through and deliver on the promise of next generation immunotherapies to create a meaningful impact on patients’ lives," said Jeff Goater, chief executive officer of Surface Oncology. "2018 was a landmark year for the company as two of our products advanced into phase 1 clinical development and we successfully completed our IPO. With three wholly-owned product candidates either in, or approaching the clinic, and a strong balance sheet, we remain focused on execution across all fronts. Our team of Surfers is ready for, and excited about, the road ahead."

Recent Corporate Highlights:

Continued dose escalation for the phase 1 trial of NZV930 (CD73), with trial sites now recruiting in four countries

Initiation of IND-enabling studies for SRF617 (CD39) and SRF388 (IL-27)

Retention of worldwide rights for SRF388, a first-in-class antibody targeting IL-27

Publication in ImmunoHorizons of research highlighting the role of IL-27 in the upregulation of multiple checkpoint proteins

Deprioritization of SRF231 (CD47) clinical program based upon dose escalation data and competitive landscape

Appointment of F. Stephen Hodi, MD to the Scientific Advisory Board

Promotion of Jessica Fees to senior vice president, finance and business operations

Addition of Surface Oncology to the NASDAQ Biotechnology Index

Selected Anticipated 2019 Corporate Milestones:

Presentation at the Brisbane Immunotherapy Conference, highlighting recent discoveries in tumor microenvironment biology in May 2019

IND filing for SRF617 in Q4 2019

IND filing for SRF388 in Q4 2019

Introduction of new program and clinical candidate in Q4 2019

Inaugural Surface Oncology Investor and Analyst Day in New York City, Q4 2019

Additional findings and learnings related to the deprioritization of SRF231 in H2 2019

Financial Results:

As of December 31, 2018, cash, cash equivalents and marketable securities were $158.8 million, compared to $63.3 million on December 31, 2017. This increase was due to the $108.7 million in net proceeds from Surface’s initial public offering and concurrent private placement completed in April 2018 and receipt of a $45.0 million milestone payment from Novartis related to NZV930, offset by operating costs during the year.

Research and development (R&D) expenses were $10.5 million for the fourth quarter ended December 31, 2018, compared to $16.3 million for the same period in 2017. The decrease was primarily driven by a reduction in costs associated with the SRF231 program, in accordance with the deprioritization of the program in the fourth quarter of 2018. R&D expenses were $52.5 million for the full year 2018, compared to $47.8 million for the same period in 2017. The increase was primarily driven by expenditures associated with Surface’s advancing product pipeline as well as increased R&D personnel costs associated with the growth of the company. R&D expenses included $2.5 million in stock-based compensation expenses for the full year 2018.

General and administrative (G&A) expenses were $4.8 million for the fourth quarter ended December 31, 2018, compared to $2.8 million for the same period in 2017. G&A expenses were $16.1 million for the full year 2018, compared to $11.0 million for the same period in 2017. The increase in G&A expenses for both the fourth quarter of 2018 and the full year 2019 was primarily due to increased personnel costs and professional fees associated with the growth of the company and operating as a public company. G&A expenses included $2.7 million in stock-based compensation expenses for the full year 2018.

For the fourth quarter ended December 31, 2018, net loss was $4.7 million, or basic and diluted net loss per share attributable to common stockholders of $0.17. Net loss was $15.8 million for the same period in 2017, or basic and diluted net loss per share attributable to common stockholders of $6.16. For the full year ended December 31, 2018, net loss was $6.6 million, or basic and diluted net loss per share attributable to common stockholders of $0.33. Net loss was $45.4 million for the same period in 2017, or basic and diluted net loss per share attributable to common stockholders of $18.35.

Financial Outlook:

Based upon its current operating plan, Surface continues to have a projected cash runway through 2021.

Quest Diagnostics Prices $500 Million of Senior Notes

On March 7, 2019 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services,reported the pricing of a public offering of $500 million aggregate principal amount of its 4.200% senior notes due 2029 under the Quest Diagnostics’ shelf registration statement (Press release, Quest Diagnostics, MAR 7, 2019, View Source [SID1234534136]).

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Quest Diagnostics expects to receive the net offering proceeds upon closing on March 12, 2019, subject to customary closing conditions. The company intends to use the net proceeds from the offering to repay outstanding indebtedness, which includes the $300 million aggregate principal amount of its senior notes due April 2019, and indebtedness under its secured receivables credit facility, and for general corporate purposes.

This press release shall not constitute an offer to sell or a solicitation of an offer to purchase any of these securities and shall not constitute an offer, solicitation or sale in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful. This offering may be made only by means of a prospectus supplement and accompanying base prospectus, copies of which or information concerning this offering may be obtained by calling Goldman Sachs & Co. LLC, toll-free at (866) 471-2526, Mizuho Securities USA LLC, toll-free at (866) 271-7403 or Morgan Stanley & Co. LLC, toll-free at (866) 718-1649.

Ayala Pharmaceuticals to Present Preclinical Data at AACR for AL101, a Pan-Notch Inhibitor Being Evaluated for Adenoid Cystic Carcinoma

On March 6, 2019 Ayala Pharmaceuticals, Inc., a clinical-stage company developing medicines for cancers that are genetically defined, reported that new data for AL101 – a gamma secretase inhibitor currently being evaluated as a potential therapy for adenoid cystic carcinoma (ACC) with Notch activating mutations – will be presented at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Atlanta, Ga (Press release, Ayala Pharmaceuticals, MAR 6, 2019, View Source [SID1234534003]).

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The details of the poster presentation are as follows:

Title: AL101 mediated tumor inhibition in Notch mutated ACC PDX models
Date and Time: Wednesday April 3, 2019, 8 a.m. – 12 p.m. EDT
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 19
Poster Board Number: 8
Permanent Abstract Number: 4885

The preclinical data that will be presented show that AL101 monotherapy has a significant effect on tumor growth inhibition in a mouse model using implanted ACC patient-derived xenograft (PDX) tumors. The effect of AL101 was only seen in PDX tumors with Notch activating mutations and not on PDX tumors without such mutations. These data support the clinical development of AL101 as a targeted monotherapy for ACC tumors bearing Notch activating mutations.

"This proof-of-concept study in genetically-defined ACC PDX models validates our patient selection strategy in the ongoing ACCURACY Phase 2 clinical trial, testing AL101 in people with ACC tumors bearing Notch activating mutations," said Roni Mamluk, Ph.D., Chief Executive Officer at Ayala Pharmaceuticals. "These encouraging results bring us one step closer to potentially helping people suffering from ACC, an underserved cancer with no standard of care."

In a previous Phase 1 all-comers solid tumor study, two ACC patients were treated with AL101, the first had partial response and the second had prolonged stable disease. This study did not apply patient selection for Notch activating mutations; however, it was confirmed that both patients had tumors with activating Notch mutations. These results promoted further evaluation of the effect of AL101 in tumors that harbor/lack Notch activated mutations.

Additionally, prior research revealed that genomic alterations in the Notch pathway yield a subset of ACC patients with a distinct phenotype and a more aggressive course of disease than their wild type counterparts. In addition to Notch 1 mutations, mutations in Notch 2 and 4 have been reported in ACC.

About AL101
AL101 is a gamma secretase inhibitor developed as a Notch inhibitor for oncology indications. Notch signaling pathway plays an important role in tumorigenesis in several solid and hematological malignancies. Upon ligand binding of the Notch receptor, an important step in the activation of Notch receptors is cleavage by gamma secretase, which frees the Notch intracellular signaling domain.

AL101 is currently in Phase 2 for adenoid cystic carcinoma patients with tumor bearing Notch activating mutations (ACCURACY). For additional information about AL101 ACCURACY clinical trial, please to www.clinicaltrials.gov. Interested patients and physicians can contact Ayala Medical for more information at: [email protected] or call refer +1-857-444-0553.

Bausch Health Completes Acquisition Of Certain Assets Of Synergy Pharmaceuticals Inc.

On March 6, 2019 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company") reported that the Company has completed the acquisition of certain assets of Synergy Pharmaceuticals Inc. (NASD: SGYP) ("Synergy") for a cash purchase price of approximately $195 million and the assumption of certain assumed liabilities, pursuant to the terms of the stalking horse asset purchase agreement previously entered into with Synergy and following approval by the U.S. Bankruptcy Court for the Southern District of New York (the "Bankruptcy Court") on March 1, 2019 (Press release, Valeant, MAR 6, 2019, View Source [SID1234534019]).

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"We are excited to welcome new team members from Synergy to join our Salix Pharmaceuticals business, a leader in gastroenterology. We believe that adding TRULANCE to our portfolio and dolcanatide to our early pipeline will organically grow this core business for the Company," said Joseph C. Papa, chairman and CEO, Bausch Health. "In 2019, Bausch Health will continue pivoting to offense with research investments and strategic acquisitions and alliances in our core businesses – therapeutic areas that will both drive Company growth and where we can have the biggest impact on the lives of the patients we serve."

Synergy’s flagship product, TRULANCE (plecanatide) is a once-daily tablet approved for adults with chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C), and its investigational compound, dolcanatide, is an incremental peptide with established proof-of-concept studies in multiple GI conditions.

Wachtell, Lipton, Rosen & Katz served as legal advisor to Bausch Health in this transaction.