1stOncology™: Cancer Intelligence Service – Page 13099 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Epigenomics AG Reports Financial Results for the First Nine Months 2019

On November 19, 2019 Epigenomics AG (FSE: ECX, OTCQX: EPGNY, the "Company") reported its financial results (IFRS, unaudited) for the first nine months of 2019 (Press release, Epigenomics, NOV 19, 2019, View Source [SID1234551457]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

Major Events After the End of the Reporting Period

On November 7, 2019, after the end of the reporting period, Epigenomics successfully completed a capital increase with gross proceeds of approximately EUR 8.3 million. The shares from the private placement were allocated to multiple investors, including, in particular, institutional investors from the U.S.A. and Germany.
On November 21, 2019, Dr. Elvira D’Andrea, one of the authors of the microsimulation model comparing outcomes of colorectal cancer screening methods, including the Epi proColon blood test, will present at the 12th European Public Health Conference of the European Public Health Association. In addition, Dr. D’Andrea, together with her colleague Dr. Medhi Najafzadeh, co-author of the model, will participate in an investor conference call on November 21 where they will discuss a summary of the presentation entitled "Quantifying the impact of adherence to screening on colorectal cancer incidence and mortality".
Greg Hamilton, CEO of Epigenomics AG: "I would like to take this opportunity to thank all our existing and new shareholders, who participated in our capital increase, for the confidence they have placed in Epigenomics. The funds raised will enable us to continue to execute on our major goal, reimbursement for our blood test Epi proColon in the U.S.A. In addition, we are looking forward to the conference call with Dr. D’Andrea and her co-author Dr. Najafzadeh in which they will present their positive study results of the microsimulation model to interested investors".

Key figures

Product revenue for the first nine months increased 28% to EUR 818 thousand compared to the same period last year. Total revenue for the period decreased year-on-year to EUR 847 thousand (9M 2018: EUR 1,315 thousand) due to lower licensing revenue.
Research and development costs increased by EUR 1.2 million to EUR 5.7 million in the 9-month period due to expenses related to the post-approval study for Epi proColon and the HCC study in the U.S.A.
Selling and administrative expenses increased from EUR 6.0 million (9M 2018) to EUR 6.9 million.
EBITDA (before share-based payment expenses) decreased from EUR -8.0 million in the comparable period of 2018 to EUR -9.7 million.
The net loss for the period was EUR -10.0 million (9M 2018: EUR -8.7 million); the loss per share fell to EUR 0.28 (9M 2018: EUR 0.36) due to the higher number of shares after the capital increase in the second half of 2018.
Cash consumption increased to EUR 10.9 million in the first three quarters of 2019 (9M 2018: EUR 6.9 million) mainly due to an increased R&D spend and changes in working capital.
As of September 30, 2019, liquidity amounted to EUR 6.3 million (including marketable securities) compared to EUR 17.1 million at year-end 2018.

Outlook 2019
Revenue

As disclosed in the prospectus for the capital increase in November 2019, the Company expects full-year 2019 revenue in a range of EUR 1.0 million to EUR 1.5 million.
EBITDA

For EBITDA before share-based payment expenses, Epigenomics forecasts a range of EUR -12.5 million to EUR -14.0 million for the full year 2019.
Further information
The interim statement for the first nine months of 2019 (unaudited) is available on the Epigenomics website: View Source

Conference call for analysts and investors
Epigenomics AG will host a conference call for analysts and investors today at 3:30 pm (CET) / 9:30 am (EST). The webcast can be accessed on the Company’s website: View Source

The dial-in numbers for the conference call are:
Dial-in number Germany: +49 30 2332 257 28
Dial-in number UK: +44 20 3872 0880
Dial-in number USA: +1 862-701-2734

Participants are kindly asked to dial in 10 minutes prior the start of the call.
An audio replay of the conference call will be provided on the Epigenomics’ website subsequently.

Interim Report Q3 2019

On November 19, 2019 Oncopeptides reported Interim result of Q3 2019 (Press release, Oncopeptides, NOV 19, 2019, View Source [SID1234551456]).

Financial overview July 1 – September 30, 2019
Net sales amounted to SEK 0.0 M (0.0)
Loss for the period was SEK 189.8 M (loss: 94.0)
Loss per share, before and after dilution, was SEK 3.53 (loss: 2.14)
On September 30 cash and cash equivalents amounted to SEK 1,122.3 M (488.9)
Significant events during the period July 1 – September 30, 2019
In late August it was announced that Klaas Bakker, MD, PhD, was appointed as Chief Medical Officer and assumed his duties in early November
In mid-September new interim data in RRMM patients with extramedullary disease (EMD) from the pivotal Phase 2 HORIZON trial were presented at the International Myeloma Workshop
At the end of September, it was announced that the patient recruitment in the pivotal Phase 2 HORIZON trial had been completed
Financial overview of the group

1) Earlier periods have been adjusted to reflect correction of errors, see note 7.

Conference call for investors, analysts and the media
The Interim Report Q3 2019 and an operational update will be presented by CEO Jakob Lindberg and members of Oncopeptides management team, Tuesday November 19, 2019 at 13:30 (CET). The conference call will also be streamed via a link on the website: www.oncopeptides.com.

Phone numbers for participants from:
Sweden: +46 8 505 583 59
Europe: +44 3333 009 034
USA: +1 833 823 05 89

Financial calendar
Year-end Report 2019: February 20, 2020
Interim Report Q1, 2020: May 26, 2020
Annual General Meeting May 26, 2020

BERGENBIO ASA: RESULTS FOR THE THIRD QUARTER 2019

On November 19, 2019 BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for multiple cancer indications, reported its results for the third quarter 2019 (Press release, BerGenBio, NOV 19, 2019, View Source [SID1234551455]).

A presentation and live webcast by the Company’s management will take place today at 10.00 am CET in Oslo, please see below for details.

Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "During the quarter we have continued working to expand our proof of concept trials in AML and NSCLC. Our goal is to confirm that the addition of our selective AXL inhibitor bemcentinib can substantially improve patient outcomes across both these indications. This will inform clinical strategy and position for late stage clinical development, and we remain committed to progressing bemcentinib through to regulatory approval."

Operational Highlights – Third quarter 2019

Non-Small Cell Lung Cancer (NSCLC)

Cohort A of the Phase II clinical trial (BGBC008) evaluating bemcentinib in combination with KEYTRUDA in patients with NSCLC met its primary endpoint.
Primary endpoint of Overall Response Rate (ORR) was met, with 33% ORR in cAXL positive patients; five times the response rate of cAXL negative patients (7%)
Response rate three times greater than that seen with Keytruda monotherapy reported in earlier clinical trials in similar patients.
Secondary endpoint of median Progression Free Survival (mPFS) reported significant 3-fold improvement in cAXL positive vs negative patients,
Data were presented at the prestigious High Impact Clinical Trial session at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (6-10 November 2019) conference in Washington DC.
Proprietary Composite AXL Immune Score (cAXL) suggests patients that express AXL in both their tumor and immune cells report significantly improved clinical benefit from bemcentib combination with Keytruda.
Data from Cohort A of BGBC008 was also presented in an oral presentation at the 2019 World Conference on Lung Cancer (WCLC) and as a poster the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress (ESMO) (Free ESMO Whitepaper).
Data suggest bemcentinib has potential to enhance patient responses and overall survival, when treated in combination with a PD-1 inhibitor, particularly in patients with no or limited expression of PD-L1, this is a very significant patient population, and a very encouraging development.
The clinical trial BGBC008 is ongoing in two additional cohorts; B) in Check Point Inhibitor refractory patients and C) in CPI/chemotherapy combination refractory patients. Preliminary data read out is anticipated in the first half of 2020.
Acute Myeloid Leukaemia (AML)

U.S Food and Drug Administration (FDA) has granted bemcentinib Fast Track Designation for the treatment of elderly patients with AML whose disease has relapsed.
The purpose of the Fast Track designation is to get important new drugs to the patients earlier
The Fast Track program is designed to facilitate the development and expedite the regulatory review of new drugs to treat serious conditions without any treatment options.
Phase IIa clinical trial data has shown that bemcentinib in combination with low-intensity chemotherapy (LDAC) in elderly AML patients is well tolerated and efficacious.
Preliminary responses were reported in 43% of evaluated patients, with complete responses in a substantially higher percentage of patients compared to previously observed/historical benchmarks in single-agent cytarabine.
Trial has been expanded to include an additional 28 patients to verify this early proof of concept, preliminary data from this expanded trial will be reported in the first half of 2020.
Financial highlights

Revenue for the third quarter 2019 and the nine months ended 30 September 2019 respectively amounted to NOK 0 million (NOK 0 million) and NOK 8.7 million (NOK 0 million). The revenue was received in Q1 2019 from ADCT as a clinical milestone payment.
Total operating expenses for the third quarter and the nine months ended 30 September 2019 respectively amounted to NOK 47.5 million (NOK 38.1 million) and NOK 154.0 million (NOK 143.6 million).
Cash and Cash equivalents at end of Q3 2019 NOK 289.5 million (NOK 398.2 in Q3 2018).
Presentation and Webcast Details

A presentation by BerGenBio’s senior management team will take place today at 10:00 am CET at:

Arctic Securities
Haakon VIIs gate 5
Oslo

The presentation will webcast live and the link will be available at www.bergenbio.com in the section Investors/Financial Reports. A recording will be available shortly after the webcast has finished.

The results report and presentation will be available at www.bergenbio.com in the section: Investors/Financial Reports from 7:00 am CET.

LabCorp Prices $400,000,000 in 2.300% Senior Notes Due 2024 and $650,000,000 in 2.950% Senior Notes Due 2029

On November 18, 2019 LabCorp (NYSE: LH) reported that it has priced its offering of $1,050,000,000 in senior notes (Press release, LabCorp, NOV 18, 2019, View Source [SID1234552830]). The offering consists of two tranches: $400,000,000 aggregate principal amount of 2.300% Senior Notes due 2024 (the 2024 Notes) and $650,000,000 aggregate principal amount of 2.950% Senior Notes due 2029 (the 2029 Notes and, together with the 2024 Notes, the Notes). The Notes will bear interest from Nov. 25, 2019, payable semi-annually on June 1 and Dec. 1, commencing on June 1, 2020. The closing of the offering is expected to occur on Nov. 25, 2019, subject to the satisfaction of customary closing conditions. The Notes will be senior unsecured obligations and will rank equally with LabCorp’s existing and future senior unsecured debt. Concurrently with this offering, LabCorp is conducting a cash tender offer for up to $300,000,000 aggregate purchase price of its 4.625% Senior Notes due Nov. 15, 2020 (the Tender Offer).

LabCorp intends to use the net proceeds of the Notes offering for general corporate purposes including (1) the purchase, redemption or repayment at maturity of its outstanding 2.625% Senior Notes due Feb. 1, 2020, (2) the concurrent Tender Offer, and (3) the repayment of some or all of the amounts outstanding under its term loan credit facilities.

The joint book-running managers for the offering are BofA Securities, US Bancorp, and Wells Fargo Securities. The offering will be made pursuant to an effective shelf registration statement on Form S-3 filed with the Securities and Exchange Commission. A copy of the prospectus and related prospectus supplement may be obtained without charge from the Securities and Exchange Commission. Alternatively, a copy of the prospectus and related prospectus supplement may be obtained from BofA Securities by calling toll-free 1-800-294-1322, from US Bancorp by calling toll-free 1-877-558-2607, or from Wells Fargo Securities by calling toll-free 1-800-645-3751.

This press release does not constitute an offer to sell or a solicitation of an offer to buy the Notes or any other securities, nor shall there be any sale of these securities in any jurisdiction in which such an offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. The offering of these securities may be made only by means of the prospectus supplement and the accompanying prospectus.

Entry into a Material Definitive Agreement.

On November 18, 2019, Phio Pharmaceuticals Corp. (the "Company") reported that it has entered into a Placement Agency Agreement (the "Placement Agency Agreement") with H.C. Wainwright & Co., LLC, as placement agent, pursuant to which the Company agreed to issue and sell, in a registered public offering of the Company (the "Offering"), 10,000,000 shares of the Company’s common stock, par value $0.0001 per share (the "Common Stock") to certain investors (Filing, 8-K, Phio Pharmaceuticals, NOV 18, 2019, View Source [SID1234551513]). The offering price was $0.10 per share of Common Stock .

Each purchaser in the Offering was required, as a condition to such purchase, to execute a subscription agreement pursuant to which they (i) agreed, effective until November 19, 2019, the record date of our next stockholder meeting, not to sell, dispose or otherwise transfer, directly or indirectly any shares of our Common Stock that they own or control as of the closing of this Offering and (ii) agreed to vote at our next stockholder meeting the shares of our Common Stock that they own or control as of the closing of this Offering in favor of an amendment of our articles of incorporation to undertake a reverse stock split of our Common Stock.

The Placement Agency Agreement contains customary representations and warranties, agreements and obligations, conditions to closing and termination provisions.

The net proceeds to the Company from the Offering is approximately $725,000, after deducting fees and expenses. The Company intends to use substantially all of the net proceeds of the Offering primarily for the development of the Company’s immuno-oncology program, for other research and development activities and for general working capital.

Pursuant to the Placement Agency Agreement, the Company agreed to pay the placement agent a cash fee of 7.5% and a management fee of 1.0% of the aggregate gross proceeds of the Offering We also agreed to pay the placement agent up to $40,000 for legal expenses and reimburse the placement agent up to $10,000 for clearing expenses. In addition, the Company, upon closing of the Offering, issued to the placement agent warrants to purchase up to 750,000 shares of Common Stock (the "Placement Agent Warrants"), or 7.5% of the aggregate number of shares of Common Stock sold in the Offering. The Placement Agent Warrants are immediately exercisable at a price of $0.125 per share of Common Stock, subject to adjustment in certain circumstances, may be exercised on a cashless basis under certain circumstances, and expire on November 19, 2024.

The shares of Common Stock sold in the Offering were offered and sold pursuant to a prospectus, dated April 6, 2018, and a prospectus supplement dated November 18, 2019, in connection with a takedown from the Company’s shelf registration statement on Form S-3 (File No. 333-224031), which was declared effective by the Securities and Exchange Commission on April 6, 2018. The Offering was made only by means of a prospectus forming a part of the effective registration statement.

The foregoing descriptions of the Placement Agency Agreement and the Placement Agent Warrants are not complete and are qualified in their entirety by reference to the full text of the Placement Agency Agreement and the forms of the Placement Agent Warrant, copies of which are filed as Exhibit 1.1 and Exhibit 4.1 to this Current Report on Form 8-K and hereby incorporated by reference herein. Attached as Exhibit 5.1 is an opinion of counsel regarding the due authorization of the Common Stock sold in the Offering.