On March 23, 2018 Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY), or the "Company", reported its financial results (according to IFRS) for the year ended December 31, 2017 (Press release, Epigenomics, MAR 23, 2018, View Source [SID1234525127]).

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KEY HIGHLIGHTS

Financial

Total revenue of EUR 1.9 million
EBITDA (before share-based payment expenses) loss of EUR 9.4 million
Liquidity of EUR 13.7 million (incl. marketable securities) at year-end following successful capital raises in 2017
Corporate

Voluntary takeover offer by Summit Hero Holding GmbH in 2017 highlighted inherent value of the Company’s products and technologies
Epigenomics AG gets CE-IVD mark for lung cancer test Epi proLung
First quarter 2018

U.S. Senators Capito and Heinrich introduce Bi-Partisan Colorectal Cancer Detection Bill aiming to provide coverage under the Medicare program for FDA-approved qualifying blood-based colorectal cancer screening tests
Greg Hamilton, Chief Executive Officer of Epigenomics, commented: "In 2017, we remained focused on our key priorities medical guideline inclusion and initial payor coverage for our innovative blood-based colon cancer test, Epi proColon, while maintaining high cost discipline in all company areas. In 2018, we expect to reach significant milestones with regard to Medicare payment and coverage for Epi proColon. The recent bipartisan legislative initiative by U.S. Senators Capito and Heinrich addresses payment as the last remaining barrier for Medicare patients associated with colon cancer screening. The passing of this bill provides to millions of underscreened rural Americans access to colon cancer screening and has the potential to ultimately save thousands of lives."

Financial results

In 2017, Epigenomics’ total revenue decreased to EUR 1.9 million (2016: EUR 4.2 million). In the previous year, our U.S. commercialization partner had initially stocked up on inventories of Epi proColon following the product’s FDA approval. Revenue of about EUR 1.3 million was generated through licensing income, product sales were at EUR 0.5 million.
Total operating costs decreased to EUR 13.2 million (2016: EUR 17.3 million). Research and development costs decreased to EUR 4.3 million (2016: EUR 5.1 million). Selling, general and administrative costs decreased to EUR 8.0 million (2016: EUR 10.2 million).
Operating loss (EBIT) in 2017 decreased to EUR -10.3 million (2016: EUR -12.3 million). Net loss for the year decreased to EUR 10.2 million (2016: EUR 11.2 million) and loss per share decreased to EUR 0.44 (2016: EUR 0.55).
Cash consumption in 2017 decreased to EUR 10.1 million (2016: EUR 13.7 million). Net cash inflows from financing activities reached EUR 11.5 million in 2017 (2016: EUR 17.4 million), net cash flow was at EUR 1.4 million (2016: EUR 3.8 million).
The Company’s liquidity (incl. marketable securities) at year-end 2017 was EUR 13.7 million (Dec 31, 2016: EUR 12.3 million).
Outlook 2018

Revenue

Our business projections for 2018 are based mainly on the commercialization of Epi proColon in the U.S.A. The commercialization of this product depends primarily on securing reimbursement from public and private health insurers. Prior to the entry into force of a reimbursement decision we expect only a slight increase in product revenue in 2018.
Overall, we expect that revenue will increase but will remain on low levels, ranging between EUR 2.0 million and EUR 4.0 million.
EBITDA

We anticipate that EBITDA before share-based payment expenses will be in a range EUR -11.5 million and EUR -14.0 million in 2018.
Cash consumption

Based on our business plans for 2018, we expect cash consumption in line with our EBITDA before share-based payment expenses guidance.
We ended the 2017 fiscal year with EUR 13.7 million in cash and marketable securities. While current financial resources are sufficient at our projected cash consumption to support the Company’s operations beyond 2018, we will raise additional capital if necessary in 2018.
The forecast cash consumption is based on our assumption that the convertible notes maturing as of December 31, 2018 will be converted with no adverse effect on liquidity, or will be extended.
Further Information

The annual report 2017 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 2.30 pm CET / 9.30 am EDT, today. The webcast can be accessed on the Company’s website: View Source

The dial-in numbers for the conference call are:

Dial-in number within Germany: +49 30 233225798

Dial-in number within the UK: +44 20 3872 0880

Dial-in number within the U.S.A.: +1 516-269-8974

Participants are kindly requested to dial in 10 minutes prior to the start of the call.

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

On March 22, 2018 BioCryst Pharmaceuticals, Inc. ("BioCryst") (NASDAQ:BCRX), and Idera Pharmaceuticals, Inc. ("Idera") (NASDAQ:IDRA), reported they will be presenting at the 17th Annual Needham Healthcare Conference on Tuesday, March 27, 2018 at 12:15 P.M. E.T. The conference is being held at the Westin New York Grand Central Hotel (Press release, Idera Pharmaceuticals, 22 22, 2018, View Source [SID1234524951]).

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On March 22, 2018 Evotec AG (Frankfurt Stock Exchange: EVT, TecDAX 30) reported that DAC (a wholly owned subsidiary of Genextra SPA) has chosen Evotec as a strategic partner to identify small molecule therapeutics in a pharmaceutical discovery project on the HSP90 target, a key protein involved in a variety of oncogenic pathways in several cancer related diseases (Press release, Evotec, MAR 22, 2018, View Source;announcements/press-releases/p/dac-selects-evotec-as-strategic-partner-for-a-drug-discovery-collaboration-on-the-hsp90-cancer-target-4520 [SID1234525395]).

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Under the agreement, DAC will access compound intellectual property that Evotec has generated on this disease target through its internal R&D activities. The aim of the collaboration will be to take compounds identified by Evotec as being active against the target and further optimise them to the point of clinical development.

Using its proprietary fragment screening platform (High Throughput Fragment Screening, HTFS), Evotec identified novel fragments that interact with the HSP90 target from Evotec’s five thousand member fragment library. Active fragments were further characterised by co-crystallisation with the target protein. The X-ray crystal structures of the protein-ligand complexes identified a variety of binding modes some of which will give rise to novel approaches for inhibiting HSP90. Following due diligence DAC has decided to collaborate with Evotec with the aim of improving the potency and selectivity of the identified compounds. In the collaboration, which may run for an initial period of over 2 years, Evotec will use its medicinal chemistry, profiling and ADMET (Absorption, Distribution, Metabolism, Excretion and Toxicity) expertise to generate lead molecules for further progression into clinical trials.

For its contributions to the discovery project Evotec will potentially receive single digit millions R&D service revenues and will also be eligible for additional preclinical and clinical milestone payments.

"We are delighted that DAC and Genextra, one of the most innovative and active biopharmaceutical companies in Italy, appreciated the value of the HSP90 inhibitors that we had identified using our novel approach to fragment screening and have selected us for this project. We are very excited about the potential for analogues of these compounds to be novel treatments for diseases that require inhibition of the HSP90 protein," said Dr Mark Ashton, Executive Vice President Business Development Services at Evotec. "This project represents another major milestone in our strategy to strengthen our collaborative relationships by providing our partners access to selected promising proprietary drug discovery assets discovered using our state-of-the-art platform."

"This project is an important extension of our lead discovery activities. From existing collaborations with Evotec, we remained positively impressed by Evotec’s medicinal chemistry capabilities and this, together with the results that Evotec had already generated against this disease target, convinced us to collaborate on this exciting project," commented Mr Paolo Fundarò, Chief Executive Officer of Genextra.

Contact: Anne Hennecke, Director, Investor Relations & Corporate Communications, Evotec AG, Phone: +49-40-56081-286, [email protected]

On March 22, 2018 Evotec AG (Frankfurt Stock Exchange: EVT, TecDAX) reported that Evotec and Apeiron Biologics have entered into a research collaboration with the objective of developing immunomodulatory lead compounds for the treatment of cancer (Press release, Evotec, MAR 22, 2018, View Source;announcements/press-releases/p/evotec-and-apeiron-biologics-announce-collaboration-on-cancer-immunotherapy-5107 [SID1234525396]). Apeiron Biologics will contribute in vitro and in vivo pharmacology expertise to this collaboration while Evotec will be responsible for medicinal chemistry as well as chemical proteomics. The collaboration is based on the successful outcome of a phenotypic high throughput screen previously commissioned by Apeiron Biologics to Evotec.

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Dr Mario Polywka, Chief Operating Officer of Evotec, commented: ‘We look forward to continue working with Apeiron on this important project. The collaboration highlights the strength of Evotec’s phenotypic screening capabilities to identify novel mechanisms and hits in important therapeutic areas.’

Dr Hans Loibner, Chief Executive Officer of Apeiron Biologics, added: ‘We were excited about the outcome of the primary screen and look forward to refining the hit compounds in this collaboration applying our immunological know-how. There is no doubt that immunomodulatory compounds like these carry huge therapeutic and commercial potential.’

No financial details are disclosed.

ABOUT APEIRON Biologics AG
Apeiron is a mostly privately financed biotech company in Vienna that develops immunological/biological therapies against cancer. Its portfolio consists of five clinical projects (lead in phase III) as well as some preclinical approaches. The most advanced project APN311 is an antibody to treat the pediatric cancer neuroblastoma. The immunocytokine hu14.18-IL2 (APN301) is being developed clinically in neuroblastoma as well as in melanoma. Moreover, recombinant human superoxide dismutase is in clinical development, notably in a topical liposomal formulation (APN201) as a potent anti-inflammatory tissue-protective biologic. Two complementary approaches are pursued (APN401, APN411) that stimulate immune cells in a novel way to treat cancer more effectively. The recombinant human Angiotensin Converting Enzyme 2 (GSK2586881, previously APN01) was licensed out to GlaxoSmithKline in early 2010 and is currently investigated in a phase II trial in patients suffering from acute lung injury. Apeiron started operations in 2006 and has 23 employees as of today.

FORWARD LOOKING STATEMENTS – Information set forth in this press release contains forward-looking statements, which involve a number of risks and uncertainties. The forward-looking statements contained herein represent the judgement of Evotec as of the date of this report. Such forward-looking statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any such statements to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based.

On March 22, 2018 Array BioPharma Inc. (Nasdaq: ARRY) reported that detailed results of its pivotal Phase 3 COLUMBUS trial for the treatment of patients with BRAF-mutant advanced, unresectable or metastatic melanoma were published in The Lancet Oncology (Press release, Array BioPharma, MAR 22, 2018, View Source;p=RssLanding&cat=news&id=2339334 [SID1234524945]). In the analysis of the primary endpoint, the median progression-free survival (mPFS) for patients treated with the combination of encorafenib, 450 mg daily, plus binimetinib, 45 mg twice daily (COMBO450) was 14.9 months versus 7.3 months for patients treated with vemurafenib, 960 mg twice daily [hazard ratio (HR) 0.54, 95% CI 0.41–0.71; p<0.0001].

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The manuscript entitled "Encorafenib plus binimetinib versus vemurafenib or encorafenib in patients with BRAF-mutant melanoma (COLUMBUS): a multicentre, open-label, randomised phase 3 trial," was published online on March 21, 2018. Array previously announced top line results from this study in September 2016.

"A median progression-free survival of nearly 15 months with the combination of encorafenib and binimetinib is clinically meaningful for patients with advanced BRAF-mutant metastatic melanoma," said Keith T. Flaherty, M.D., Director of the Termeer Center for Targeted Therapy, Massachusetts General Hospital Cancer Center and Professor of Medicine, Harvard Medical School. "Further, a median overall survival of 33.6 months, compared to 16.9 months with vemurafenib monotherapy (HR of 0.61, 95% CI 0.47-0.79, p<0.001), a secondary endpoint not included in this publication, was recently announced. This further supplements the published data and shows that the combination of encorafenib and binimetinib may become a promising new therapy for patients with advanced BRAF-mutant metastatic melanoma."

As previously reported, the combination of encorafenib and binimetinib was generally well-tolerated. The median duration of treatment was 51.2 weeks (27.1-79.7) for encorafenib and 50.6 weeks (26.1-79.7) for binimetinib. The median dose intensity was 100% (93-100) of planned doses of encorafenib and 99.6% (80-100) of planned doses of binimetinib. The most common Grade 3/4 adverse events (AEs) seen in more than 5% of patients were increased gamma-glutamyltransferase (GGT) 9% (18/192 patients), increased creatine phosphokinase 7% (13), and hypertension 6% (11) in the encorafenib plus binimetinib group.

The U.S. Food and Drug Administration (FDA) is currently reviewing the New Drug Applications to support use of the combination of encorafenib and binimetinib for the treatment of patients with BRAF-mutant advanced, unresectable or metastatic melanoma. The FDA set a target action date under the Prescription Drug User Fee Act (PDUFA) of June 30, 2018 for both applications. In addition, the European Medicines Agency (EMA), as well as the Swiss Medicines Agency (Swissmedic) and the Australian Therapeutic Goods Administration (TGA), are reviewing the Marketing Authorization Applications for encorafenib and binimetinib.

An update from the COLUMBUS trial will be presented at an upcoming medical congress.

About Melanoma
Metastatic melanoma is the most serious and life-threatening type of skin cancer and is associated with low survival rates. [1, 2] There are about 200,000 new cases of melanoma diagnosed worldwide each year, approximately half of which have BRAF mutations, a key target in the treatment of metastatic melanoma. [1, 3, 4]

About COLUMBUS
The COLUMBUS trial, (NCT01909453), is a two-part, international, randomized, open label Phase 3 trial evaluating the efficacy and safety of the combination of encorafenib and binimetinib compared to vemurafenib and encorafenib monotherapy in 921 patients with locally advanced, unresectable or metastatic melanoma with BRAFV600 mutation. Prior immunotherapy treatment was allowed. Over 200 sites across North America, Europe, South America, Africa, Asia and Australia participated in the trial. Patients were randomized into two parts:

In Part 1, 577 patients were randomized 1:1:1 to receive COMBO450, encorafenib, 300 mg daily (ENCO 300), or vemurafenib, 960 mg twice daily alone. The dose of encorafenib in the combination arm is 50% higher than the single agent maximum tolerated dose of 300 mg. A higher dose of encorafenib was possible due to improved tolerability when combined with binimetinib. The primary endpoint for the COLUMBUS trial was an mPFS comparison of the COMBO450 arm versus vemurafenib. mPFS is determined based on tumor assessment (RECIST version 1.1 criteria) by a Blinded Independent Central Review (BICR). Secondary endpoints include a comparison of the mPFS of COMBO450 arm to that of ENCO300 and a comparison of overall survival (OS) in patients treated in the COMBO450 arm to that of vemurafenib alone. Results from Part 1 of the COLUMBUS trial previously presented at the 2016 Society for Melanoma Research Annual Congress, showed that COMBO450 more than doubled mPFS in patients with advanced BRAF-mutant melanoma, with a mPFS of 14.9 months compared with 7.3 months observed with vemurafenib [HR 0.54, (95% CI 0.41-0.71, p<0.0001)]. In the secondary mPFS comparison of COMBO450 to ENCO300, ENCO300 demonstrated a mPFS of 9.6 months [HR 0.75, (95% CI 0.56-1.00, p=0.051)].
In Part 2, 344 patients were randomized 3:1 to receive encorafenib 300 mg plus binimetinib 45 mg twice daily (COMBO300) or ENCO300. Part 2 was designed to provide additional data to help evaluate the contribution of binimetinib to the combination of encorafenib and binimetinib.
As the secondary endpoint comparison of mPFS between the COMBO450 arm and ENCO300 arm in Part 1 did not achieve statistical significance, the protocol specified analysis of OS is descriptive.

About Encorafenib and Binimetinib
BRAF and MEK are key protein kinases in the MAPK signaling pathway (RAS-RAF-MEK-ERK). Research has shown this pathway regulates several key cellular activities including proliferation, differentiation, survival and angiogenesis. Inappropriate activation of proteins in this pathway has been shown to occur in many cancers including melanoma and colorectal cancer. Encorafenib is a late-stage small molecule BRAF inhibitor and binimetinib is a late-stage small molecule MEK inhibitor, both of which target key enzymes in this pathway. Encorafenib and binimetinib are being studied in clinical trials in advanced cancer patients, including the Phase 3 BEACON CRC trial and the Phase 3 COLUMBUS trial.

Array BioPharma has exclusive rights to encorafenib and binimetinib in the U.S. and Canada. Array has granted Ono Pharmaceutical exclusive rights to commercialize both products in Japan and South Korea and Pierre Fabre exclusive rights to commercialize both products in all other countries, including Europe, Asia and Latin America. Encorafenib and binimetinib are investigational medicines and are not currently approved in any country.