On November 7, 2018 Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY) reported its financial results for the third quarter and the nine months 2018 ending September 30 (Press release, Epigenomics, NOV 7, 2018, View Source [SID1234531201]).

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Recent operational highlights

-In September 2018, U.S. Congress urged the Centers of Medicare & Medicaid Services (CMS) to consider coverage of blood tests for colorectal cancer screening as part of the approved 2019 Health and Human Services (HHS) Appropriations Bill – a positive step towards legislative approval of CMS coverage for Epigenomics’ blood test for colorectal cancer screening Epi proColon.

-In October 2018, CMS published the final reimbursement rate of $192 for Epi proColon. The $192 per test rate will be included in the 2019 Clinical Laboratory Fee Schedule that is expected to be published in November 2018.

-In October 2018, Epigenomics successfully completed a capital increase with subscription rights for existing shareholders generating gross proceeds of EUR 22.3 million. New shares that were not subscribed for during the subscription period were subsequently offered to selected qualified investors as part of an international private placement. The private placement was significantly oversubscribed. All shares of the private placement were allocated to multiple new institutional investors in the U.S.A, including healthcare funds.

-In October 2018, Epigenomics has received CE Mark for its blood test to aid in detecting liver cancer among patients with cirrhosis two months ahead of schedule. The test will be commercialized under the brand name "HCCBloodTest". In 2019, the company plans to initiate a prospective clinical trial in the U.S. for submission to the FDA. Simultaneously, Epigenomics is evaluating options to expedite CFDA approval in China.

-In October 2018, the Veterans Administration – New York Harbor Healthcare System has commenced a study to assess the adherence impact of offering a blood-based colorectal cancer screening test and colonoscopy completion in patients who have refused colonoscopy and fecal immunochemical test (FIT). The goal of the study is to assess the potential of a blood-based test as an acceptable alternative for these screen-resistant individuals.

"We have made significant progress against our strategic goals over the last couple of weeks and months", said Greg Hamilton, CEO of Epigenomics AG. "The successful completion of our capital increase gives us the opportunity to further pursue our mission of developing and commercializing liquid biopsy tests for some of the deadliest cancer diseases worldwide. I would like to thank our existing and new shareholders for the trust in our company as demonstrated by the strong participation in the recent capital increase."

Q3/9M 2018 Financial Results

-Total Q3 2018 revenue increased to EUR 0.5 million (Q3 2017: EUR 0.3 million) and 9M 2018 revenue to EUR 1.3 million (9M 2017: EUR 0.9 million). In Q3 2018, product revenue increased by 73% to EUR 0.3 million.

-Adjusted for non-cash expenses related to share-based payment, EBITDA in Q3 2018 was at EUR -2.6 million (Q3 2017: EUR -2.0 million); adjusted EBITDA for 9M 2018 amounted to
EUR -8.0 million (9M 2017: EUR -7.8 million). Net loss amounted to EUR -3.0 million in Q3 2018 compared to EUR -1.1 million in Q3 2017, and EUR -8.7 million for 9M 2018 (9M 2017: EUR -7.6 million). The increase in net loss was mainly due to higher R&D expenses, partially offset by growth in gross profit.

-Net loss per share for Q3 2018 increased to EUR -0.12 (Q3 2017: EUR -0.05) and for 9M 2018 to EUR -0.36 (9M 2017: EUR -0.33).

-Cash consumption (cash outflow from operating and investing activities) was EUR 6.9 million in 9M 2018 compared to EUR 7.3 million in 9M 2017.

-Liquid assets (including marketable securities) amounted to EUR 6.6 million at September 30, 2017 (December 31, 2017: EUR 13.7 million).

Outlook for 2018

-As recently announced in the prospectus for the capital increase, due to the delay of reimbursement decisions in the U.S.A, Epigenomics narrowed its revenue forecast for the full year 2018 to a range of EUR 1.5 million and EUR 2.5 million (previously: EUR 2.0 – 4.0 million).

-Adjusted EBITDA (excluding share-based payment expenses) is now expected to improve within the range EUR -11.0 million and EUR -13.0 million (previously: EUR -11.5 to -14.0 million).

Organizational matters

-The Supervisory Board resolved to extend the service agreement with the Company’s Chief Executive Officer Greg Hamilton until December 31, 2021.

Further Information

The report on the third quarter 2018 can be downloaded from Epigenomics’ website at:
View Source

Conference call for analysts and investors

The Company will host a conference call and webcast at 4.00 pm CET / 10.00 am EST, today. The presentation can be downloaded from the Company’s website.

The dial-in numbers for the conference call are:

Germany: +49 69 2475 01899
UK: +44 20 3872 0885
USA: +1 516-269-8983

The webcast will be made available on: View Source

An audio replay of the conference call will be provided on Epigenomics’ website subsequently.

On November 7, 2018 Neurocrine Biosciences, Inc. (NASDAQ: NBIX) reported that it will present at the Jefferies 2018 London Healthcare Conference at 11:20 a.m. GMT (6:20 a.m. ET) on Wednesday, Nov. 14, 2018, in London (Press release, Neurocrine Biosciences, NOV 7, 2018, View Source;p=RssLanding&cat=news&id=2375955 [SID1234531198]). Kevin Gorman, Chief Executive Officer, and Matt Abernethy, Chief Financial Officer, will present at the conference.

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The live presentation will be webcast and may be accessed on the Company’s website under Investors at www.neurocrine.com. A replay of the presentation will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month

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.