On November 7, 2018 Supernus Pharmaceuticals, Inc. (NASDAQ: SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases, reported that the Company’s management will present an overview and Company update as well as host investor meetings, at the following three conferences (Press release, Supernus, NOV 7, 2018, View Source [SID1234531188]):

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Stifel 2018 Healthcare Conference
Date: Tuesday, November 13, 2018
Time: 3:30 p.m. EST
Place: Lotte New York Palace Hotel, New York

Jefferies 2018 London Healthcare Conference
Date: Thursday, November 15, 2018
Time: 2:40 p.m. GMT (9:40 a.m. EST)
Place: Waldorf Hilton, London, U.K.

Piper Jaffray 30th Annual Healthcare Conference
Date: Tuesday, November 27, 2018
Time: 12:00 p.m. EST
Place: Lotte New York Palace Hotel, New York

Investors interested in arranging a meeting with the Company’s management during these conferences should contact the respective conference coordinators.

A live webcast of the respective presentations can be accessed by visiting ‘Events & Presentations’ in the Investor Relations section on the Company’s website at www.supernus.com. An archived replay of these webcasts will be available for 60 days after the respective conferences on the Company’s website.

On November 7, 2018 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported its financial results for the third quarter of 2018 (Press release, Navidea Biopharmaceuticals, NOV 7, 2018, View Source [SID1234531187]). Navidea reported total revenues for the quarter of $231, 000. Net loss attributable to common stockholders was $3.8 million.

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"Navidea had a productive quarter as we advanced the business and our novel imaging pipeline," said Mr. Jed A. Latkin, Chief Executive Officer of Navidea. "We also continued to gain recognition from the scientific and medical communities, receiving acceptance into the National Institutes of Health’s ("NIH") Commercialization Accelerator Program and presenting encouraging data on Tc99m tilmanocept, the first product developed and commercialized by the Company based on the Manocept platform, at the American College of Rheumatology ("ACR") Annual Meeting. The Company also presented its Phase II data to the U.S. Food and Drug Administration ("FDA") at the end of September. These accomplishments reflect the strength of our team and the potential of our pipeline of innovative diagnostics. Importantly, acceptance into the NIH’s program in addition to a $3 million private placement by a long-term investor provides us with assistance to advance our Rheumatoid Arthritis ("RA") program and product portfolio. I am pleased with our progress and look forward to a strong finish to the year."

Third Quarter 2018 Highlights and Subsequent Events

Closed $3 million private placement with an existing investor

Announced acceptance into the NIH’s Commercialization Accelerator Program for 2018-2019

Presented data on the Manocept platform at the 2018 ACR Annual Meeting

Presented at the 2018 BIO Investor Forum in California

Held meeting with the FDA to discuss the results from the Phase II RA trial and activated macrophage data and next steps for the program

Announced leadership transition in which Dr. Michael Goldberg stepped down as CEO and Board member of Navidea and Mr. Jed Latkin was appointed CEO of Navidea

Held the Annual Shareholder Meeting

Financial Results

Our consolidated balance sheets and statements of operations have been reclassified, as required by current accounting standards, for all periods presented to reflect the line of business sold to Cardinal Health 414, LLC in March 2017 as a discontinued operation. Accordingly, this discussion focuses on describing results of our operations as if we had not operated the discontinued operation during the periods being disclosed.

Total revenues for the third quarter of 2018 were $231,000 compared to $224,000 in the third quarter of 2017. The increase was primarily due to a royalty revenue related to our license agreement with SpePharm in Europe as well as a license revenue for activities related to the sublicense of NAV4694 to Meilleur Technologies, Inc. and the sublicense of Tc99m tilmanocept to Beijing Sinotau Medical Research Co., Ltd. No royalty revenue or license revenue was recognized during the third quarter of 2017. Total revenues for the first nine months of 2018 were $1.1 million compared to $1.4 million for the same period in 2017. Revenue included royalty and license revenue as well as grant revenue, primarily related to SBIR grants from the NIH supporting Manocept development. Other revenue for the first nine months of 2018 was from our marketing partners in Europe and China related to development work performed at their request.

Research and development ("R&D") expenses for the third quarter of 2018 were $1.2 million compared to $875,000 in the third quarter of 2017. R&D expenses for the first nine months of 2018 were $3.4 million compared to $2.8 million during the same period in 2017. The increase was primarily due to net increases in drug project expenses related to increased therapeutics development costs from research consulting, regulatory consulting, and preclinical testing.

Selling, general and administrative ("SG&A") expenses for the third quarter of 2018 were $2.7 million, compared to $1.7 million in the third quarter of 2017. The net increase was primarily due to increased compensation including incentive-based awards as well as termination costs associated with the resignation of our former CEO. SG&A expenses for the first nine months of 2018 were $6.3 million, compared to $9.0 million during the same period in 2017. The net decrease was primarily due to decreased legal and professional services, as well as decreased general office, insurance, depreciation, rent, and travel expenses.

Navidea’s net loss attributable to common stockholders for the quarter ended September 30, 2018 was $3.8 million, or $0.02 per share (basic), compared to a net loss attributable to common stockholders of $1.4 million, or $0.01 per share, for the same period in 2017. Navidea’s net loss attributable to common stockholders for the nine-month period ended September 30, 2018 was $13.0 million, or $0.08 per share (basic), compared to net income attributable to common stockholders of $79.0 million, or $0.49 per share, for the same period in 2017.

Navidea ended the third quarter of 2018 with $6.5 million in cash and investments.

Conference Call Details

Investors and the public are invited to dial into the earnings call through the information listed below. Participants who would like to ask questions during the question and answer session must participate by telephone.

Event:

Third Quarter 2018 Earnings and Business Update Conference Call

Date:

Wednesday, November 7, 2018

Time:

4:30 pm (Eastern Time)

U.S. & Canada Dial-in:

877-407-0312

Conference ID:

13684819

A live audio webcast of the conference call will also be available on the investor relations page of Navidea’s corporate website at www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea’s website.

On November 7, 2018 Achieve Life Sciences, Inc. (Nasdaq: ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation, reported third quarter 2018 financial results (Press release, OncoGenex Pharmaceuticals, NOV 7, 2018, View Source [SID1234531181]).

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Recent Highlights

The United States Adopted Name Council, or USAN, adopted cytisinicline as the nonproprietary (generic) name for the substance also known as cytisine

Announced initiation of the first trial in the ORCA (Ongoing Research of Cytisinicline for Addiction) Program. This Phase 2b optimization study will evaluate approximately 250 smokers in the U.S.

Reported results of a clinical study evaluating the effect of food on the bioavailability of a new formulation for cytisinicline

Closed registered direct offering for gross proceeds of $5.6 million

Announced positive cytisinicline data published in the International Journal of Drug Policy

Rick Stewart, Chairman and Chief Executive Officer of Achieve Life Sciences commented, "We are pleased with our continued progress made in the third quarter, particularly the initiation of the ORCA-1 trial that will provide critical insights to inform our Phase 3 program expected to initiate in the second-half of 2019."

"Cytisinicline" Designated as New Generic Name for Cytisine

The United States Adopted Names (USAN) Council adopted cytisinicline as the nonproprietary (generic) name in Q3 2018. USAN is responsible for selecting simple, informative, and unique generic drug names. The USAN Council establishes logical nomenclature classifications based on pharmacological and/or chemical relationships.

Initiated Phase 2b "ORCA-1"Optimization Trial

ORCA-1 is the first in Achieve’s ORCA (Ongoing Research of Cytisinicline for Addiction) Program that aims to evaluate the effectiveness of cytisinicline for smoking cessation and potentially other indications. This Phase 2b trial will evaluate both the 1.5mg and 3mg doses of cytisinicline on a declining titration schedule over 25 days, as well as three times daily dosing. The trial is randomized and blinded to compare the effectiveness of the cytisinicline doses and schedules to respective placebo groups. The primary efficacy endpoint is reduction in the number of cigarettes smoked during treatment with secondary analyses to be conducted on smoking cessation rates, safety, and compliance. ORCA-1 is being conducted at eight centers across the U.S. and results are expected in mid-2019.

Announced Study Results for New Formulation

The study evaluated the bioavailability of a new formulation of cytisinicline under fed and fasted conditions in 12 healthy volunteer smokers. Results demonstrated bioequivalence when cytisinicline was administered with or without food and that the 3mg dose of this new formulation was well tolerated.

Completed $5.6M Financing

Achieve announced the closing of a registered direct offering that raised total gross proceeds of $5.6 million and after deducting approximately $0.6 million in placement agent fees and offering expenses, receiving net proceeds of $5.0 million.

Publication of New Cytisinicline Data in the International Journal of Drug Policy

Results of an observational study comparing the effectiveness of cytisinicline and nicotine replacement therapy (NRT) as an aid to smoking cessation in the Russian Federation determined that smokers in the cytisinicline group were approximately three times more likely to achieve 90-days abstinence compared to those who attempted to quit with NRT (p=0.011). The authors concluded the findings support previous trial evidence indicating that cytisinicline is superior to NRT for achieving short- and long-term abstinence and should be considered a first-line pharmacologic treatment for smoking cessation.

Financial Results

As of September 30, 2018, the company’s cash, cash equivalents, short-term investments and restricted cash were $13.2 million. Total operating expenses for the three and nine months ended September 30, 2018 were $3.3 million and $9.1 million, respectively. Total net loss for the three and nine months ended September 30, 2018 was $3.2 million and $9.1 million, respectively

As of November 7, 2018 Achieve had 6,721,103 shares outstanding.

Conference Call Details

Achieve will host a conference call at 4:30 p.m. Eastern time today, Wednesday, November 7, 2018, to provide an update on the cytisinicline clinical development program and announce third quarter 2018 financial results. To access the webcast, log on to the Investor Relations page of the Achieve website at View Source Alternatively, you may access the live conference call by dialing (877) 472-9809 (U.S. & Canada) or (629) 228-0791 (International) and referencing conference ID 9922429. A webcast replay will be available approximately two hours after the call and will be archived on the website for 90 days.

On November 7, 2018 Bausch Health Companies Inc. (NYSE/TSX: BHC) reported that Joseph C. Papa, chairman and chief executive officer, and Arthur J. Shannon, senior vice president and head of Investor Relations and Communications, are scheduled to participate at the Stifel 2018 Healthcare Conference in New York on Nov. 14, 2018 at 11:00 a.m. ET (Press release, Valeant, NOV 7, 2018, View Source [SID1234531177]).

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A live webcast and audio archive of the event will be available on the Investor Relations page of the Bausch Health Companies Inc. web site at: View Source

On November 7, 2018 MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported financial results for the quarter ended September 30, 2018 (Press release, MacroGenics, NOV 7, 2018, View Source [SID1234531176]).

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"During the third quarter, MacroGenics made tremendous progress in advancing its portfolio of immuno-oncology product candidates towards multiple near-term data read-outs," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "Given the Company’s substantial pipeline progress over the past several months, we believe that the next twelve months are poised to be transformative for MacroGenics, during which we expect to continue to advance our core mission of developing breakthrough biologics that may become life-changing medicines for patients."

Key Pipeline Updates
Margetuximab. Recent highlights related to the Company’s Fc-optimized monoclonal antibody (mAb) that targets the human epidermal growth factor receptor 2, or HER2, include:
• Fully Enrolled Phase 3 Metastatic Breast Cancer Study. The Company has completed enrollment of 530 relapsed/refractory HER2-positive metastatic breast cancer patients in its pivotal SOPHIA study. MacroGenics anticipates disclosure of topline PFS data in the first quarter of 2019. In anticipation of a potential future product launch, MacroGenics is progressing its U.S. commercial planning and actively exploring ex-U.S. development and commercialization partnership opportunities.
• Phase 2 Gastric Cancer Study Demonstrated Antitumor Activity. At the 2018 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in October, MacroGenics presented updated interim clinical data from a Phase 2 study of margetuximab plus an anti-PD-1 agent in patients with HER2-positive gastroesophageal adenocarcinoma. This chemotherapy-free combination, designed to coordinately engage innate and adaptive immunity, demonstrated antitumor activity in patients with advanced gastric cancer. The Company recently completed enrollment of 25 additional gastric cancer patients and expects to present data from this ongoing portion of the study in the first quarter of 2019.

PD-1 Franchise. MacroGenics is advancing multiple PD-1-directed programs to provide further differentiation from existing PD-1-based treatment options and enable a broad set of combination opportunities across the Company’s portfolio. Recent program highlights include:

Exhibit 99.1
• MGA012 Achieves Development Milestones. This anti-PD-1 mAb, also known as INCMGA0012, was licensed to Incyte Corporation in 2017 under a global collaboration and license agreement. MacroGenics retains the rights to develop MGA012 in combination with its pipeline assets. MGA012 met certain clinical proof-of-concept criteria, triggering a total of $15 million in milestones from Incyte, $10 million of which has been recognized in the third quarter and $5 million of which is expected to be recognized in the fourth quarter. Incyte plans to present updated data from the cohort expansion portion of the Phase 1 study of MGA012 in a poster session at the upcoming Society for Immunotherapy for Cancer (SITC) (Free SITC Whitepaper) Annual Meeting. Incyte has announced its intention to pursue monotherapy development of MGA012 in MSI-high endometrial cancer, Merkel cell carcinoma and anal cancer through registration-directed studies with initial data anticipated in 2020. In addition, across both Incyte and MacroGenics, multiple studies have been initiated which will feature various combination regimens with MGA012.
• MGD013 Dose Expansion Initiated. This first-in-class DART molecule provides co-blockade of two immune checkpoint molecules expressed on T cells, PD-1 and LAG-3, for the potential treatment of a range of solid tumors and hematological malignancies. MacroGenics recently established the dose and schedule for MGD013 administration and has initiated dose expansion in up to nine tumor types in a Phase 1 study.
• MGD019 IND Cleared. This DART molecule is designed to provide co-blockade of both PD-1 and CTLA-4, two immune checkpoint inhibitors, on T cells. MacroGenics’ Investigational New Drug (IND) application for MGD019 was cleared by the FDA and the Company is currently engaged in Phase 1 study startup.
B7-H3 Franchise. MacroGenics is developing a portfolio of therapeutics that target B7-H3, a member of the B7 family of molecules involved in immune regulation. The Company is advancing multiple programs that target B7-H3 through complementary mechanisms of action that take advantage of this antigen’s broad expression across multiple solid tumor types. Recent program highlights include:
• Enoblituzumab Oral Presentation at SITC (Free SITC Whitepaper): Clinical data from MacroGenics’ study of this Fc-optimized mAb that targets B7-H3 combined with an anti-PD-1 mAb was selected for oral presentation at the upcoming SITC (Free SITC Whitepaper) Annual Meeting. Like the combination of margetuximab and anti-PD-1, enoblituzumab and anti-PD-1 is designed to leverage Fc-optimization and checkpoint blockade to coordinately engage innate and adaptive immunity, the two major components of the immune response. As an update of the recently released abstract, the combination of enoblituzumab and anti-PD-1 demonstrated antitumor activity in checkpoint inhibitor-naïve patients who had squamous cell carcinoma of the head and neck (SCCHN) and in checkpoint inhibitor-naïve patients with non-small cell lung cancer (NSCLC) with tumor PD-L1 expression of <1%. In these two cohorts, objective responses occurred in 6/18 (33%) response-evaluable SCCHN patients and in 5/14 (36%) response-evaluable NSCLC patients. Additional details will be provided at SITC (Free SITC Whitepaper).
• Orlotamab Studies Ongoing: This DART molecule targeting B7-H3 and CD3 is being evaluated in a Phase 1 monotherapy study in multiple tumor types. In addition, a combination study of orlotamab and MGA012 is ongoing.
• MGC018 Phase 1 Startup Initiated: MacroGenics’ IND submission for this anti-B7-H3 antibody-drug conjugate (ADC) was cleared by the FDA and the Company is initiating a Phase 1 study. This first-in-man study is designed to study MGC018 both as monotherapy and in combination with MGA012 in patients with solid tumors.
Flotetuzumab. Recent highlights of the Company’s bispecific, humanized DART molecule that recognizes both CD123 and CD3, include:
• Oral Presentations at ASH (Free ASH Whitepaper). MacroGenics plans to present both updated clinical data as well as gene signature data from its completed acute myeloid leukemia (AML) dose expansion cohort in two oral presentations at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting next month. The Company’s collaborator, Servier, has development and commercialization rights outside North America, Japan, Korea and India for flotetuzumab, also known as S80880.

Exhibit 99.1
• Combination Study with MGA012 Planned. MacroGenics has previously presented data supporting the rationale for using checkpoint blockade as an approach to potentially enhance the anti-leukemic activity of flotetuzumab and plans to commence a combination study with MGA012.

Third Quarter 2018 Financial Results
• Cash Position: Cash, cash equivalents and marketable securities as of September 30, 2018, were $260.1 million, compared to $305.1 million as of December 31, 2017.
• Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was $20.8 million for the quarter ended September 30, 2018, compared to $1.7 million for the quarter ended September 30, 2017. This increase was primarily due to revenue recognized under the Incyte MGA012 collaboration. Revenue from collaborative agreements includes the recognition of deferred revenue from payments received in previous periods as well as payments received during the year.
• R&D Expenses: Research and development expenses were $46.2 million for the quarter ended September 30, 2018, compared to $41.0 million for the quarter ended September 30, 2017. This increase was primarily due to the initiation of combination studies of MGA012, continued enrollment in multiple ongoing studies, increased development/manufacturing costs related to MGA012, which were partially reimbursed by Incyte, and increased headcount to support expanded manufacturing and development activities.
• G&A Expenses: General and administrative expenses were $9.6 million for the quarter ended September 30, 2018, compared to $8.4 million for the quarter ended September 30, 2017. This increase was primarily due to increased patent-related expenses and consulting and other costs incurred related to the implementation of the Company’s new enterprise resource planning (ERP) system.
• Net Loss: Net loss was $34.0 million for the quarter ended September 30, 2018, compared to net loss of $47.0 million for the quarter ended September 30, 2017.
• Shares Outstanding: Shares outstanding as of September 30, 2018 were 42,248,075.

Conference Call Information

MacroGenics will host a conference call today at 4:30 pm (ET) to discuss financial results for the quarter ended September 30, 2018 and provide a corporate update. To participate in the conference call, please dial (877) 303-6253 (domestic) or (973) 409-9610 (international) five minutes prior to the start of the call and provide the Conference ID: 6548008.

The recorded, listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company’s website at View Source A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days following the call.