On May 9, 2018 Quanterix Corporation (NASDAQ:QTRX), a company digitizing biomarker analysis to advance the science of precision health, reported financial results for the first quarter 2018 (Press release, Quanterix, MAY 9, 2018, View Source [SID1234526390]).

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"The first full quarter following the successful close of our initial public offering marked an important milestone in our transition as a public company, particularly as we continue our focus on growing revenues and transforming biomarker detection by enabling non-invasive, ultra-sensitive measurement of molecular biomarkers," said Chief Executive Officer, President and Chairman, Kevin Hrusovsky. "We are pleased with our strong first quarter performance and enthusiastic about the market opportunity in front of us, particularly in research markets for improving drug development with biomarkers and pharma services in the short to mid-term and in diagnostics and precision health screens in the long term."

First Quarter 2018 Financial Highlights

Key financial results for the first quarter are shown below:

Q1 revenue of $7.5M versus prior year Q1 of $5.3M, an increase of 41%.

Q1 product revenue was $4.7M versus prior year Q1 of $3.4M, an increase of 38%.

Q1 Service and Other revenue totaled $2.5M versus prior year Q1 of $1.6M, an increase of 52%.

First Quarter 2018 Business Highlights

As previously noted, Quanterix successfully completed the acquisition of Aushon BioSystems on Jan. 30, 2018 and has begun to successfully integrate the two businesses. Major benefits of the Aushon transaction include:

acquired an ultra-sensitive protein detection technology, complimentary to Simoa;

acquired a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory, expanding services and accelerating entry into pharmaceutical drug trial services;

gained access to Aushon’s menu of over 200 assays, many with multiplexing capabilities;

accessed a talented work force allowing us to accelerate assay development; and
,
inherited an additional facility (close to the Quanterix headquarters), enabling cost-effective expansion of operations to meet growing demand.

Expanded operations in Asia, particularly working through distributors in China.

Successfully closed first full quarter of sales of the new SR-X Ultra-Sensitive Biomarker Detection System.

Began a collaboration with DestiNA Genomics in an effort to transform microRNA biomarker detection, bringing together high-specificity and ultra-sensitivity for the first time.

Surpassed more than 100 third-party, peer-reviewed publications in neurology, as driven by increased demand for the Company’s Simoa technology, bringing the total number of publications for the Company to over 215 across neurology, oncology, cardiology, inflammation and infectious disease.

Named as partner candidate in the FNIH (Foundation for National Institutes of Health) Biomarkers Consortium, which launched a project to improve diagnosis and treatment of neurodegenerative and psychiatric diseases.

Reinforced the Company’s leadership position in the market through presentations from Kevin Hrusovsky, Chief Executive Officer, President and Chairman, at The 36th Annual J.P. Morgan Healthcare Conference, PULSE The Atlantic Summit on Health Care, The Lake Nona Impact Forum, Cowen and Company 38th Annual Healthcare Conference, and Needham and Company’s 17th Annual Healthcare Conference, as well as receiving an exclusive invite to be a part of Fortune Brainstorm Health.

Announced that Quanterix will be a platinum sponsor for the third-annual Powering Precision Health Summit to be held in Boston Dec. 11-12, 2018. This summit aims to bring all key stakeholders together in order to transform reactive sick care into preventative healthcare, focusing on neurology, oncology and infectious disease application areas. Previous conferences have attracted over 600 attendees from around the world and helped underscore the importance of Quanterix’ technologies for enabling personalized medicine and precision health.

Conference Call

In conjunction with this announcement, Quanterix Corporation will host a conference call on May 9, 2018, at 4:30 p.m. EDT to discuss the Company’s financial results and business outlook. To access this call, dial (833) 686-9351 for domestic callers, or (612) 979-9890 for international callers. Please reference the following password:2576325.

A live webcast will be accessible on the Investors section of Quanterix’ website: View Source The webcast will be available on the Company’s website for one year following completion of the call

On May 9, 2018 Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD) a clinical-stage biopharmaceutical company focused on the development of CART-cell therapies, reported that the company will present recent advances in Celyad’s pipeline at the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting being held May 16–19, 2018, in Chicago.

Poster presentations will highlight the recent developments of Celyad’s pipeline in autologous and allogeneic platforms to address cancers. The oral presentation will give updated data of the ongoing THINK Phase 1 trial with the case report of a CYAD-01 associated complete response in one relapsed/refractory AML patient, including observations concerning the modulation of systemic chemokines during the course of treatment.

David Gilham, VP of Research and Development at Celyad, commented: ‘Our presentations at the 2018 meeting of the ASGCT (Free ASGCT Whitepaper) will share our increasing knowledge around our lead NKG2D CAR T cell candidate along with discussing our pipeline including the B7H6 CAR T program and our allogeneic platform. These presentations are the culmination of an intensive level of activity within our R&D group. We anticipate that this will lead to a series of assets that will enter clinical stage testing during 2019.’

Presentation Details:

Title

Early Signs of Clinical Activity in AML Patients Receiving NKG2D CAR-T Cell Therapy in the Absence of Pre-Conditioning Chemotherapy: An Alternative Strategy to CAR-T Cell Therapy

Link

Number

967

Category

Cancer-Immunotherapy, Cancer Vaccines

Session

412 Advancements in T Cell-Based Therapies

Session Date & Time

Saturday, May 19, 2018, 11:00 AM CDT

Location

Continental Ballroom ABC

Posters Details:

Poster title
Functional screening of a B7H6 specific chimeric antigen receptor (CAR)

Link

Poster Number

123

Category

Cancer – Immunotherapy, Cancer Vaccines I

Session

Exhibit Hall Welcome Reception & Poster Session I

Session Date & Time

Wednesday, May 16, 2018, 5:30 PM CDT

Location

Stevens Salon C, D

Poster Title

Overcoming target-driven fratricide for CAR-T cell therapy

Link

Poster Number

119

Category

Cancer-Immunotherapy, Cancer Vaccines

Session

Exhibit Hall Welcome Reception & Poster Session I

Session Date & Time

Wednesday, May 16, 2018, 5:30 PM CDT

Location

Stevens Salon C, D

Poster Title

Expression of a TIM8 peptide reduces alloreactivity of T cells facilitating an allogeneic NKG2D Chimeric Antigen Receptor T cell therapy approach

Link

Poster Number

457

Category

Cell Therapies

Session

Exhibit Hall Networking Reception & Poster Session II

Session Date & Time

Thursday, May 17, 2018, 5:15 PM CDT

Location

Stevens Salon C, D

On May 9, 2018 Epigenomics AG (FSE: ECX, OTCQX: EPGNY), or the "Company", reported its financial results for the first quarter 2018 ended March 31 (Press release, Epigenomics, MAY 9, 2018, View Source [SID1234526298]).

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Q1/2018 Financial results

-Total revenue slightly increased to EUR 309 thousand (Q1 2017: EUR 281 thousand) due to higher product sales (+38%).

-Operating costs increased to EUR 3.6 million (Q1 2017: EUR 3.1 million), mainly due to higher R&D expenses for the FDA required Epi proColon post approval study.

-Operating loss (EBIT) increased to EUR 3.3 million (Q1 2017: EUR 2.7 million). EBITDA (loss) before expenses for share-based compensation increased to EUR 3.2 million (Q1 2017: EUR 2.4 million).

-Net loss increased to EUR 3.2 million (Q1 2017: EUR 2.4 million). Loss per share increased to EUR 0.13 (Q1 2017: EUR 0.10).

-Cash consumption increased to EUR 2.4 million (Q1 2017: EUR 1.6 million).

-The Company’s liquidity (cash, cash equivalents and marketable securities) at the reporting date was EUR 11.2 million (Dec 31, 2017: EUR 13.7 million).

Operational highlights

-Senators Capito and Heinrich Introduce Bi-Partisan Colorectal Cancer Detection Bill: Senators Shelley Moore Capito (R -WV) and Martin Heinrich (D – NM), introduced the "Colorectal Cancer Detection Act of 2018" to the United States Senate in Washington D.C. This Senate Bill (S. 2523) is parallel to House Bill (H.R. 1578) "Donald Payne Sr. Colorectal Cancer Detection Act" introduced by Congressman Donald M. Payne, Jr. (D – NJ). These bipartisan initiatives aim to provide payment and coverage under the Medicare program for FDA-approved qualifying colorectal cancer screening blood-based tests.

-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.

Outlook 2018 confirmed

-The Company confirms the outlook for the financial year 2018 as provided in the Annual Report 2017 published on March 23, 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.

-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 report on the first 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 3.30 pm CET / 9.30 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 598062
USA: +1 516-269-8980

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 May 9, 2018 Audentes Therapeutics, Inc. (Nasdaq: BOLD), a biotechnology company focused on developing and commercializing innovative gene therapy products for patients living with serious, life-threatening rare diseases, reported that Natalie Holles, President and Chief Operating Officer, will present at the Bank of America Merrill Lynch Health Care Conference in Las Vegas, NV (Press release, Audentes Therapeutics, MAY 9, 2018, View Source;p=RssLanding&cat=news&id=2348070 [SID1234526345]). The presentation is scheduled for Wednesday, May 16, 2018, at 11:20 am PT.

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To access a live webcast of the presentation, please visit the Events & Presentations page within the Investors + Media section of the Audentes website. A replay of the live webcast will be available on the Audentes website for approximately 30 days following the conference.

On May 9, 2018 Jounce Therapeutics, Inc. (NASDAQ:JNCE), a clinical stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported financial results and provided a corporate update for the quarter ended March 31, 2018 (Press release, Jounce Therapeutics, MAY 9, 2018, View Source;p=RssLanding&cat=news&id=2348006 [SID1234526375]).

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"The first quarter of 2018 has marked a time of consistent progress for our JTX-2011 clinical program and preclinical pipeline," said Richard Murray, Ph.D., chief executive officer and president of Jounce Therapeutics. "We remain focused on our key value drivers that we set forth at the start of 2018 as we work to transform the cancer treatment paradigm by delivering immunotherapies with long-lasting benefits. The current unmet medical need for many cancer types remains high and Jounce is committed to understanding the tumor microenvironment and how to interrogate it in meaningful and successful ways."

Upcoming Clinical Milestones and Research Highlights:

Jounce will report preliminary efficacy data from two ICONIC Phase 2 combination cohorts, gastric cancer and triple negative breast cancer, at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.
Jounce remains on track to initiate a JTX-2011 and CTLA-4 inhibitor combination arm of ICONIC, starting with safety dose escalation, and expects to provide further updates this year.
In April 2018, Jounce presented two posters at the 2018 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. The data, from genomic and histology-based nonclinical translational studies, identified ICOS as a potential target for therapeutic intervention for gastric cancer and triple negative breast cancer, supporting the inclusion of these cancer types in the ongoing ICONIC trial.
Jounce remains on track to file an Investigational New Drug (IND) application for JTX-4014, its internal anti-PD-1 antibody in 2018.
Jounce announced that it advanced its first, tumor associated macrophage candidate from its Translational Science Platform into IND-enabling studies.
First Quarter 2018 Financial Results:

Cash Position: As of March 31, 2018, cash, cash equivalents and investments were $237.2 million, compared to $257.9 million as of December 31, 2017. This decrease was due to operating costs incurred during the quarter.
Collaboration Revenue: Collaboration revenue was $11.2 million for the first quarter of 2018, compared to $20.3 million for the same period in 2017. Collaboration revenue represents revenue recognition relating to the $225.0 million upfront payment received in July 2016 upon the execution of Jounce’s global strategic collaboration with Celgene. The decrease in collaboration revenue was primarily due to the adoption of Accounting Standards Codification Topic 606, Revenue from Contracts with Customers (ASC 606). Under ASC 606, Jounce has transitioned from recognizing revenue on a straight-line basis to recognizing revenue based on the pattern of performance under the global strategic collaboration with Celgene.
Research and Development (R&D) Expenses: R&D expenses were $18.2 million for the first quarter of 2018, compared to $15.0 million for the same period in 2017. The increase in R&D expenses was primarily due to $1.4 million in increased employee compensation costs related to increased headcount, $0.8 million in increased clinical and regulatory costs related to the Phase 1/2 ICONIC study of JTX-2011 and $0.7 million in increased external research and development costs, primarily attributable to IND enabling activities related to JTX-4014.
General and Administrative (G&A) Expenses: G&A expenses were $6.8 million for the first quarter of 2018, compared to $5.6 million for the same period in 2017. The increase in G&A expenses was primarily due to $0.9 million in increased employee compensation costs primarily related to stock-based compensation expense and $0.4 million in increased professional services fees primarily attributable to operating as a public company.
Net (Loss) Income: Net loss was $13.0 million for the first quarter of 2018, or a basic and diluted net loss per share attributable to common stockholders of $0.40. Net income was $0.4 million for the same period in 2017, or a basic and diluted net loss per share attributable to common stockholders of $0.02 as a result of preferred stock dividends that were accrued prior to the completion of Jounce’s initial public offering. The increase in net loss per share attributable to common stockholders is primarily attributable to the decrease in collaboration revenues and the increase in operating expenses from the first quarter of 2017 to the first quarter of 2018.
Financial Guidance:

Based on its current plans, Jounce continues to expect cash burn on operating expenses and capital expenditures for the full year 2018 to be approximately $80.0 million to $100.0 million and expects to record approximately $50.0 million to $60.0 million in collaboration revenue in 2018 from the recognition of the Celgene upfront payment received in 2016.

Given the strength of its balance sheet, Jounce expects its existing cash, cash equivalents and investments to be sufficient to enable the funding of its operating expenses and capital expenditure requirements for at least the next 24 months.

Conference Call and Webcast Information:

Jounce Therapeutics will host a live conference call and webcast today at 8:00 a.m. ET. To access the conference call, please dial (866) 916-3380 (domestic) or (210) 874-7772 (international) and refer to conference ID 3760478. The live webcast can be accessed under "Events & Presentations" in the Investors and Media section of the company’s website at www.jouncetx.com. The webcast will be archived and made available for replay on the company’s website approximately two hours after the call and will be available for 30 days.

Cautionary Note Regarding Forward-Looking Statements:

Various statements in this release concerning Jounce’s future expectations, plans and prospects, including without limitation, Jounce’s expectations regarding operating expenses, capital expenditures, collaboration revenue and other financial results, release of data from the Phase 1/2 ICONIC trial, expansion of the JTX-2011 program, the filing of an IND for JTX-4014 and the timing, progress and results of preclinical studies and clinical trials for Jounce’s product candidates and any future product candidates may constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws and are subject to substantial risks, uncertainties and assumptions. You should not place reliance on these forward looking statements, which often include words such as "anticipate," "believe," "estimate," "expect," "intend," "may," "on track," "plan," "predict," "target," "potential" or similar terms, variations of such terms or the negative of those terms. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, the Company cannot guarantee such outcomes. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, Jounce’s ability to successfully demonstrate the efficacy and safety of its product candidates and future product candidates, the preclinical and clinical results for its product candidates, which may not support further development and marketing approval, the potential advantages of Jounce’s product candidates, the development plans of its product candidates, actions of regulatory agencies, which may affect the initiation, timing and progress of pre-clinical studies and clinical trials of its product candidates, Jounce’s ability to obtain, maintain and protect its intellectual property, Jounce’s ability to manage operating expenses, Jounce’s ability to maintain its collaboration with Celgene, as well as those risks more fully discussed in the section entitled "Risk Factors" in Jounce’s most recent annual or quarterly report and in other reports that Jounce has filed with the Securities and Exchange Commission. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.