On August 8, 2018 Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY) reported its financial results for the second quarter and the first six months 2018 ending June 30 (Press release, Epigenomics, AUG 8, 2018, View Source [SID1234528654]).

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"While we continue to pursue our objective of Medicare coverage for Epi proColon in the U.S., we are moving forward with our innovative liver cancer surveillance test", said Greg Hamilton, CEO of Epigenomics AG. "Based on the recently published excellent clinical data, this new blood-test could provide the next major opportunity for our company. Obtaining CE mark by year-end will be a key milestone for the product."

Q2/6M 2018 Financial Results

-Total Q2 2018 revenue increased to EUR 0.5 million (Q2 2017: EUR 0.2 million) and 6M 2018 revenue grew to EUR 0.8 million (6M 2017: EUR 0.5 million) due to higher revenue in the United States and license payments made by our partner in China.

-Product revenue in Q2 2018 increased by 65% to EUR 0.3 million (Q2 2017: EUR 0.2 million). In the six month period 2018, product revenue increased by 56% to EUR 0.4 million (6M 2017: EUR 0.2 million).

-Adjusted for non-cash expenses related to share-based payment expenses, EBITDA in Q2 2018 was at EUR -2.2 million (Q2 2017: EUR -3.4 million); adjusted EBITDA for 6M 2018 amounted to EUR -5.4 million (6M 2017: EUR -5.8 million). The lower EBITDA loss is mainly due to increased revenue and lower SG&A expenses.

-Net loss amounted to EUR 2.6 million in Q2 2018 compared to EUR 4.1 million in Q2 2017, and EUR 5.8 million for 6M 2018 (6M 2017: EUR 6.5 million). Net loss per share for Q2 2018 decreased to EUR 0.11 (Q2 2017: EUR 0.18) and for 6M 2018 to EUR 0.24 (6M 2017: EUR 0.28).

-Cash consumption (cash outflow from operating and investing activities) was EUR 4.2 million in 6M 2018 compared to EUR 4.7 million in 6M 2017.

-Liquid assets (including marketable securities) amounted to EUR 9.4 million at the reporting date (December 31, 2017: EUR 7million).

Operational highlights

-Centers for Medicare & Medicaid Services published preliminary rate for Epigenomics’ colorectal cancer screening test Epi proColon: The Centers for Medicare & Medicaid Services (CMS) published a preliminary reimbursement rate of $192 per Epi proColon test. Based on the proposed preliminary rate, CMS will determine the final rate. The publication of the final rate is expected in November 2018.

-Blood test shows promise in the detection of liver cancer: Results from two clinical studies published in EBioMedicine supported by Cell Press and The Lancet, demonstrated high accuracy of Epigenomics’ proprietary epigenetic circulating biomarker mSEPT9 in detecting liver cancer among patients with cirrhosis. In the studies, the mSEPT9 test exhibited higher diagnostic accuracy than the currently established diagnostic marker. A further independent, prospective clinical study with 440 patients was initiated.

-Liquid biopsy test for liver cancer detection to obtain CE mark: Epigenomics announced it’s plan to CE mark the mSEPT9 blood test by year-end 2018 as an aid in detecting liver cancer among patients with cirrhosis. In 2019, the Company also plans to initiate a prospective clinical trial in the U.S. for submission to the FDA. Additionally, Epigenomics is evaluating options to expedite CFDA approval in China. Epigenomics estimates the liver cirrhosis surveillance market to be in excess of 10 million tests per year making it more than a three billion Euro market opportunity globally.

Outlook 2018 confirmed

-The Company confirms the outlook for the financial year 2018 as provided in its Annual Report 2017.

-Overall, we expect that revenue will increase but will remain on low levels, ranging between EUR 2.0 million and EUR 4.0 million.

-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.

Further Information

The interim report for the first six months 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 2.30 pm CET / 8.30 am EDT, today. The presentation can be followed on the Company’s website.

The dial-in numbers for the conference call are:

Germany: +49 30 232531428
UK: +44 1635 598060
USA: +1 516-269-8983

The webcast will be made available on: View Source;lang=en

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

On August 8, 2018 Endocyte, Inc. (Nasdaq:ECYT), a biopharmaceutical company developing targeted therapeutics for personalized cancer treatment, reported that the company’s management team will present at the 2018 Wedbush PacGrow Healthcare Conference on Tuesday, Aug. 14, at 3:40 p.m. EDT (Press release, Endocyte, AUG 8, 2018, View Source [SID1234528652]).

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A live audio webcast of the Company’s presentation can be accessed by visiting "Events & Presentations" under the Investors & News section of Endocyte’s website at www.endocyte.com. The webcast will be archived shortly after the live event, and a replay will be available on the Company’s website for 90 days following the conference.

Website Information

Endocyte routinely posts important information for investors on its website, www.endocyte.com, in the "Investors & News" section. Endocyte uses this website as a means of disclosing material information in compliance with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the "Investors & News" section of Endocyte’s website, in addition to following its press releases, SEC filings, public conference calls, presentations and webcasts. The information contained on, or that may be accessed through, Endocyte’s website is not incorporated by reference into, and is not a part of, this document.

On August 8, 2018 Magenta Therapeutics (NASDAQ: MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of bone marrow transplant to more patients, reported that the Company is scheduled to present at the 2018 Wedbush PacGrow Healthcare Conference on Tuesday, August 14th, at 9:10 a.m. ET (Press release, Magenta Therapeutics, AUG 8, 2018, View Source [SID1234528623]).

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A live webcast of the presentation can be accessed under "Events & Presentations" in the Investors and Media section of the company’s website at www.magentatx.com. A replay of the webcast will be archived on the Magenta website for 30 days following the presentation.

On August 8, 2018 BeiGene, Ltd. (NASDAQ:BGNE), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported the closing of its previously announced Hong Kong initial public offering and global offering (the "Offering") of 65,600,000 ordinary shares, par value $0.0001 per share (the "Shares"), at a public offering price of HK$108.00 per Share (Press release, BeiGene, AUG 8, 2018, View Source;p=RssLanding&cat=news&id=2362884 [SID1234528621]). Based on an assumed exchange rate of HK$7.8478 to US$1.00, the public offering price equates to US$13.76 per Share, or US$178.90 per American Depositary Share ("ADS"). BeiGene’s ADSs are currently listed on the Nasdaq Global Select Market under the symbol "BGNE" and each ADS represents 13 ordinary shares. The Shares began trading today on the Main Board of the Stock Exchange of Hong Kong Limited under the stock code "06160".

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The gross proceeds to BeiGene from the Offering, before deducting underwriting discounts and commissions and other offering expenses, are approximately HK$7.08 billion, or approximately US$903 million. In addition, BeiGene has granted the joint global coordinators a 30-day option to purchase up to an additional 9,840,000 Shares at the public offering price, less underwriting discounts and commissions.

BeiGene intends to use net proceeds from the Offering for clinical trials, preparation for registration filings, and for the launch and commercialization of its core product candidates (zanubrutinib, tislelizumab, and pamiparib), as well as to fund continued expansion of its product portfolio in cancer and potentially other therapeutic areas, and for working capital, expanding internal capabilities, and general corporate purposes.

Morgan Stanley & Co. International plc, Goldman Sachs (Asia) L.L.C., Credit Suisse (Hong Kong) Limited and CLSA Limited acted as joint global coordinators, joint bookrunners and joint lead managers for the Global Offering. China International Capital Corporation Hong Kong Securities Limited, Deutsche Bank AG, Hong Kong Branch, UBS AG Hong Kong Branch acted as joint bookrunners and joint lead managers. China Renaissance Securities (Hong Kong) Limited acted as joint lead manager.

Sales of Shares outside of Hong Kong, initially offered in the United States and sold outside the United States that may be resold from time to time in the United States, are being offered pursuant to an automatically effective shelf registration statement that was previously filed with the U.S. Securities and Exchange Commission (the "SEC"). The final prospectus supplement relating to and describing the terms of the Offering was filed with the SEC on August 3, 2018 and is available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to these securities may be obtained for free from the offices of Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014; Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1-866-471-2526, or email:[email protected]; and Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, One Madison Avenue, New York, New York 10010, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.

On August 8, 2018 Foamix Pharmaceuticals Ltd. (NASDAQ: FOMX) ("Foamix" or the "Company"), a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical foams to address unmet needs in dermatology, reported its financial results for the second quarter and six months ended June 30, 2018 (Press release, Foamix, AUG 8, 2018, View Source [SID1234528609]).

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Clinical and Corporate Update:

The final patient was enrolled and dosed in the third Phase 3 study (FX2017-22) investigating FMX101, the Company’s minocycline foam 4%, in patients with moderate-to-severe acne.
Top-line results are expected in the third quarter of 2018.
The final patient has been enrolled and dosed in two Phase 3 clinical studies (FX2016-11 and FX2016-12) evaluating the safety and efficacy of FMX103, topical minocycline foam 1.5%, for the treatment of papulopustular rosacea.
Top-line results are expected early in the fourth quarter of 2018.
In April 2018, the Company raised net proceeds of approximately $16.1 million, through a direct registered offering of approximately 2.9 million shares at a price of $5.50 per share to OrbiMed Partners Master Fund Limited.
Cash & Investments
At June 30, 2018, the Company had $56.4 million in cash and investments compared to $76.4 million at December 31, 2017. During the second quarter, the Company raised net proceeds of $16.1 million, after deducting offering expenses, in a registered share offering with OrbiMed Partners Master Fund Limited. The Company believes that its existing cash and investments will be sufficient to fund operating expenses and capital expenditure requirements for the third Phase 3 clinical trial for FMX101 and NDA filing for FMX101, and for the two Phase 3 clinical trials for FMX103, which it expects to complete in 2019.

Financial Results for the Second Quarter Ended June 30, 2018
Revenues
Revenues for the second quarter of 2018 were $964,000 an increase of $166,000, or 20.8%, from $798,000 in the second quarter of 2017. The increase is due to an increase in royalty payments from Bayer for sales of Finacea Foam (azelaic acid 15%).

Operating Expenses
Research and Development Expenses
Research and development expenses for the second quarter were $16.8 million, a $2.9 million, or 20.9%, increase from $13.9 million in the second quarter of 2017. The increase in R&D expenses resulted primarily from an increase of $3.0 million in costs relating predominantly to FMX101 and FMX103 clinical trials, and an increase of $688,000 in payroll and payroll-related expenses including share-based compensation primarily due to an increase in headcount and salary raises, off-set by a decrease of $1.0 million in compensation to one of the Company’s co-founders in the second quarter of 2017.

Selling, General and Administrative Expenses
Selling, general and administrative expenses for the second quarter of 2018 were $2.9 million, a decrease of $542,000, or 15.5%, compared to $3.5 million in the second quarter of 2017. The decrease in selling, general and administrative expenses resulted primarily from a decrease of $1.2 million in compensation to one of the Company’s co-founders in the second quarter of 2017, off-set by an increase of $280,000 in payroll and other payroll-related expenses including share-based compensation mostly due to an increase in headcount and salary raises, an increase of $360,000 in advisory and professional fees and an increase of $150,000 in rent, maintenance and office expenses.

Net Loss
For the quarter ended June 30, 2018, the Company recorded a net loss of $18.6 million, or ($0.46) per share, basic and diluted, compared with a loss of $16.4 million or ($0.44) per share, basic and diluted, for the three months ended June 30, 2017.

Financial Results for the First Half Ended June 30, 2018
Revenues
Revenues for the six months ended June 30, 2018 were $1.9 million, an increase of $145,000, or 8.4%, from $1.7 million in the first six months of 2017. The increase is due to an increase in royalty payments from Bayer for sales of Finacea Foam.

Operating Expenses
Research and Development Expenses
Research and development expenses for the six months ended June 30, 2018 were $39.7 million, a $13.1 million, or 49.2%, increase from $26.6 million in the first six months of 2017. The increase in research and development expenses resulted primarily from an increase of $12.2 million in costs relating predominantly to FMX101 and FMX103 clinical trials and an increase of $1.5 million in payroll and payroll-related expenses including share-based compensation primarily due to a change in the measurement of share-based compensation expenses of a consultant and an increase in headcount and salary raises, off-set by a decrease of $1.2 million in compensation to one of the Company’s co-founders in the first half of 2017 and an increase of $383,000 in travel-related expenses.

Selling, General and Administrative Expenses
Selling, general and administrative expenses for the six months ended June 30, 2018 were $6.7 million, an increase of $437,000, or 6.9%, compared to $6.3 million in the same six month period of 2017. The increase in selling, general and administrative expenses resulted primarily from an increase of $1.5 million in payroll and payroll-related expenses including share-based compensation, mostly due to an increase in headcount, salary raises and accounting modification relating to share-based compensation expenses of a consultant, off-set by a decrease of $1.5 million in compensation to one of the Company’s co-founders in the first half of 2017; an increase of $526,000 in advisory and professional services expenses, off-set by a decrease of $112,000 in travel-related expenses.

Net Loss
For the six months ended June 30, 2018, the Company recorded a net loss of $44.6 million, or ($1.15) per share, basic and diluted, compared with a loss of $30.8 million, or ($0.82) per share, basic and diluted, for the six month ended June 30, 2017.