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Institut Curie and Freenome Announce a Strategic Collaboration in Cell-Free DNA Analysis Using Machine Learning Technology

On March 29, 2018 Institut Curie and Freenome reported a strategic collaboration to evaluate Freenome’s artificial intelligence (AI) genomics platform as a novel tool to predict patient response to immuno-oncology therapies by observing changes in circulating cell-free biomarkers (Press release, Institut Curie, 29 29, 2018, View Source [SID1234525067]).

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In recent years so-called liquid biopsies have established the possibility of detecting circulating fragments of tumor DNA (ctDNA) and circulating tumor cells (CTCs) in the blood of patients with cancer. Institut Curie has been a pioneer in the field since the late 90’s with the first program on disseminated tumor cell (DTC) detection in the bone marrow of patients with early breast cancer. Since then, Institut Curie’s Circulating Tumor Biomarkers Laboratory has developed numerous innovative ctDNA techniques (ddPCR and NGS-based techniques).

Meanwhile, Freenome’s breakthrough use of machine learning looks beyond tumor DNA and processes the full range of cell-free (cf) biomarkers in the blood. By assembling an ever-expanding library of cell-free disease signatures, Freenome is developing a range of non-invasive blood tests for the early detection of cancer and early prediction of response to various oncology therapies. As a first step in this collaboration with Institut Curie, Freenome will analyze samples from the Analysis of Circulating Tumor Markers in the Blood (ALCINA) Trial, an umbrella trial allowing assessment of different circulating biomarkers and their correlation with clinical and pathological characteristics pertaining to response to PD-1 inhibitors alone and in combination with other therapies.

"Our machine learning scientists and molecular biologists are evaluating the cell-free genome – given 60-80%1,2,3 of cfDNA comes from immune cells – and other analytes. These provide a more complete picture of the dynamic interaction between the tumor and its environment," said Blandine Merino, VP of Business Development at Freenome. "Our approach incorporates a variety of biological signals, such as genomic, proteomic and epigenetic changes, providing new insights into possible mechanisms of resistance and guiding treatment selection for patients."

There is currently a high unmet need for biomarkers with high sensitivity and specificity for response prediction in immuno-oncology. The analysis of these data could open the way to new targets in precision oncology and improve therapeutic decision-making, particularly with the limitations associated with current approaches such as PD-L1 expression testing and assessing tumor mutational burden. Freenome’s tests would help to identify patients who are more likely to respond to PD-1 inhibitors; currently, approximately 80% of patients with advanced non-small-cell lung cancer, for example, do not respond to PD-1 inhibitors.4,5

According to Pr. François-Clement Bidard, Principal Investigator at Institut Curie, "Freenome is developing a novel approach which could revolutionize the way we analyze cell-free biomarkers for patients with cancer treated with immunotherapy; this approach complements a pipeline of innovative research projects that is ongoing at Institut Curie Circulating Tumor Biomarkers Laboratory."

Amaury Martin, Head of Institut Curie Technology Transfer and Industrial Partnerships Office and Director of the Institut Carnot Curie Cancer, added, "This agreement is one of the first at the Institut Curie with a company specializing in both cell free biomarkers and applying machine learning to large data sets. The Institut Curie MC21 strategic plan has identified innovation around liquid biopsy and big data as a major axis of medical-scientific research. With the arrival of a Data Director, Institut Curie, through its Carnot Institute, is determined to take a leading position in this key area for personalized medicine in oncology. The technologies developed by Freenome will fully benefit our patients and its access within the Institute will speed up future collaborations for developing and validating predictive tests."

About Freenome

Freenome is an AI genomics company on a mission to empower everyone with the tools they need to prevent, detect, and treat their diseases. By applying advanced machine learning techniques to recent breakthroughs in genomic science, Freenome is developing noninvasive blood tests to detect early-stage cancer and make treatments more effective. The company has raised $78 million from investors such as Andreessen Horowitz, Google Ventures, Polaris Partners, and Founders Fund.

For more information: View Source

AngioDynamics Reports Fiscal 2018 Third Quarter Financial Results

On March 29, 2018 -AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, surgery and oncology, reported financial results for the third quarter of fiscal year 2018, which ended February 28, 2018 (Press release, AngioDynamics, 29 29, 2018, View Source [SID1234525066]).

"Our third quarter results demonstrate continued execution against our operational goals as evidenced by meaningful gross margin expansion and strong profitability. Revenue growth remains negatively impacted by competitive headwinds in our Venous and PICCs product lines, but we continue to believe that our ongoing portfolio evaluation and reshaping efforts will drive long-term sustainable top-line growth," commented Jim Clemmer, President and Chief Executive Officer of AngioDynamics, Inc. "We remain committed to creating value through both organic efforts and M&A as we continue transforming AngioDynamics into a dynamic leader in our industry."

Third Quarter 2018 Financial Results

Net sales for the third quarter of fiscal 2018 were $83.9 million, a decrease of 2.0%, compared to $85.6 million a year ago, primarily related to declines in the Company’s Venous Insufficiency business, as well as a negative year-over-year comparison related to the RFA product line, which was discontinued in Japan. Japanese RFA sales in the third quarter of fiscal 2017 were $1.7 million.

Currency did not have a significant impact on the Company’s sales in the quarter.

Peripheral Vascular net sales in the third quarter of fiscal 2018 were $48.5 million, a decrease of 0.8% from $48.9 million a year ago, as growth in the Fluid Management, AngioVac, and Angiographic Catheter product lines was offset by declines in the Venous Insufficiency business. Vascular Access net sales were $23.3 million, a decrease of 1.7% from $23.7 million a year ago, as growth in Midlines and other BioFlo related products was more than offset by declines in PICCs. Oncology/Surgery net sales were $12.1 million, a decrease of 7.2% from $13.0 million a year ago, as lower sales related to the discontinued RFA product noted above were only partially offset by mid-teens growth in sales of both NanoKnife and the Solero Microwave Tissue Ablation System.

U.S. net sales in the third quarter of fiscal 2018 were $65.8 million, a decrease of 2.8% from $67.7 million a year ago, primarily due to declines in the Venous, PICCs, and RFA businesses. International net sales in the third quarter of fiscal 2018 were $18.1 million, an increase of 0.7% from $17.9 million a year ago, primarily due to consistent performance across each of the business units, partially offset by the decrease in sales of our discontinued RFA product line in Japan.

Gross margin for the third quarter of fiscal 2018 expanded 300 basis points to 54.2% from 51.2% a year ago largely as a result of ongoing operational improvements, recently completed facility consolidations, and the expiration of a royalty arrangement in the second quarter of this fiscal year.

The Company recorded net income of $14.0 million, or $0.37 per share, in the third quarter of fiscal 2018. This compares to net income of $2.9 million, or $0.08 per share, a year ago. The improvement in net income was primarily attributable to the re-measurement of deferred taxes pursuant to the U.S. Tax Reform, resulting in a tax benefit of $9.9 million, compared to a prior-year tax expense of $1.7 million.

Excluding the items shown in the non-GAAP reconciliation table below, adjusted net income for the third quarter of fiscal 2018 was $9.5 million, or $0.25 per share, compared to adjusted net income of $6.9 million, or $0.19 per share, in the third quarter of fiscal 2017.

Adjusted EBITDAS in the third quarter of fiscal 2018, excluding the items shown in the reconciliation table below, was $16.8 million, compared to $14.9 million in the third quarter of fiscal 2017.

In the third quarter of fiscal 2018, the Company generated $4.3 million in operating cash flow and $3.9 million in free cash flow. As of February 28, 2018, the Company had $53.6 million in cash and cash equivalents and $93.8 million in debt, excluding the impact of deferred financing costs.

Nine Months Financial Results

For the nine months ended February 28, 2018:

Net sales were $256.0 million, a decrease of 2.6%, compared to $262.7 million for the same period a year ago.
The Company’s net income was $14.2 million, or $0.38 per share, compared to net income of $17.9 million, or $0.49 per share, a year ago.
Excluding the items shown in the non-GAAP reconciliation table below, adjusted net income for the nine months ended February 28, 2018 was $19.9 million, or $0.53 per share, compared to adjusted net income of $20.2 million, or $0.55 per share, a year ago.
Adjusted EBITDAS, excluding the items shown in the reconciliation table below, was $41.5 million, compared to $44.4 million for the same period a year ago.
Fiscal Year 2018 Financial Guidance

The Company reaffirms its previously announced financial guidance and expects its fiscal year 2018 net sales in the range of $345 to $350 million and free cash flow in the range of $30 to $35 million, excluding the cash payment related to the previously disclosed Department of Justice legal matters that the Company now anticipates paying during the fourth quarter. The Company expects its adjusted earnings per share in the range of $0.64 to $0.68, excluding any impact from the recently enacted 2017 Tax Reform Act. Including the impact of Tax Reform, guidance for adjusted earnings per share is $0.70 to $0.74.

Conference Call

The Company’s management will host a conference call today at 8:00 a.m. ET to discuss its third quarter 2018 results.

To participate in the conference call, dial 1-877-407-0784 (domestic) or 1-201-689-8560 (international) and refer to the passcode 13677111.

This conference call will also be webcast and can be accessed from the "Investors" section of the AngioDynamics website at www.angiodynamics.com. The webcast replay of the call will be available at the same site approximately one hour after the end of the call.

A recording of the call will also be available from 11:00 a.m. ET on Thursday, March 29, 2018, until 11:59 p.m. ET on Thursday, April 5, 2018. To hear this recording, dial 1-844-512-2921 (domestic) or 1-412-317-6671 (international) and enter the passcode 13677111.

Use of Non-GAAP Measures

Management uses non-GAAP measures to establish operational goals and believes that non-GAAP measures may assist investors in analyzing the underlying trends in AngioDynamics’ business over time. Investors should consider these non-GAAP measures in addition to, not as a substitute for or as superior to, financial reporting measures prepared in accordance with GAAP. In this news release, AngioDynamics has reported adjusted EBITDAS, adjusted gross margin, adjusted net income, adjusted earnings per share and free cash flow. Management uses these measures in its internal analysis and review of operational performance. Management believes that these measures provide investors with useful information in comparing AngioDynamics’ performance over different periods. By using these non-GAAP measures, management believes that investors get a better picture of the performance of AngioDynamics’ underlying business. Management encourages investors to review AngioDynamics’ financial results prepared in accordance with GAAP to understand AngioDynamics’ performance taking into account all relevant factors, including those that may only occur from time to time but have a material impact on AngioDynamics’ financial results. Please see the tables that follow for a reconciliation of non-GAAP measures to measures prepared in accordance with GAAP.

Verastem to Present at the H.C. Wainwright Global Life Sciences Conference

On March 29, 2018 Verastem, Inc. (NASDAQ: VSTM), focused on developing and commercializing drugs to improve the survival and quality of life of cancer patients, reported that the Company will present at the H.C. Wainwright Global Life Sciences Conference on Monday, April 9, 2018 at 11:05 am CEST in Monte Carlo, Monaco (Press release, Verastem, MAR 29, 2018, View Source;p=RssLanding&cat=news&id=2340273 [SID1234525065]).

A live webcast of the presentation will be available on the investors section of the Company’s website at www.verastem.com. An archived presentation will be available for 90 days.

Onxeo Reports Full-Year 2017 Financial Results and Provides Business Update

On March 29, 2018 Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO FR0010095596), a biotechnology company specializing in the development of innovative drugs in oncology, in particular against rare or resistant cancers, reported its consolidated full-year financials, as of December 31, 2017 and provided a business update (Press release, Onxeo, MAR 29, 2018, View Source [SID1234525063]).

"2017 was a pivotal year for Onxeo that demonstrated the depth of our development pipeline and the strength of our translational expertise. Shortly following our decision to conclude the development of Livatag in liver cancer, we quickly and successfully shifted our focus towards innovative and high-value mechanisms of action in oncology, DNA-targeting and epigenetics. This strategic shift is supported by two key development assets, AsiDNA and belinostat, as well as our unique proprietary chemistry platform of decoy oligonucleotides, platON. AsiDNA, our first-in-class DNA repair inhibitor generated from this platform, is currently the subject of an extensive development program aimed at demonstrating the breadth of its potential applications in oncology. Importantly, our robust AsiDNA preclinical program has already generated compelling outcomes as a single therapy, as well as significant synergy in combination with other treatments, including belinostat or PARP inhibitors. AsiDNA will shortly enter its second phase I clinical trial, DRIIV, as a systemic monotherapy in solid tumors, with initial results expected before the end of 2018. These results will be crucial to confirming the potency of AsiDNA via systemic administration. Furthermore, we intend to expand our development pipeline in the near-term with new innovative molecules screened from the platON platform. Specifically, a new compound generated from platON is expected to enter pre-clinical development by the end of 2018. Finally, based on the divestment of multiple non-core products, our cost-reduction plan and a successful international private placement, the Company’s cash position of €14.3 million at the end of 2017 is expected to support the continued planned advancement of our development programs well beyond the key value-creating milestones anticipated this year," said Judith Greciet, CEO of Onx

IntelGenx Reports Fourth Quarter and Full-Year 2017 Financial Results

On March 29, 2018 IntelGenx Technologies Corp. (TSX-V:IGX) (OTCQX:IGXT) (the "Company" or "IntelGenx") reported financial results for the fourth quarter and twelve-month periods ended December 31, 2017 (Press release, IntelGenx, MAR 29, 2018, View Source [SID1234525061]). All dollar amounts are expressed in U.S. currency and results are reported in accordance with United States generally accepted accounting principles except where noted otherwise.

2017 Fourth Quarter Financial Highlights:

Revenue was $1.5 million, compared to $1.9 million in the fourth quarter of 2016
Adjusted EBITDA was ($600,000), compared to $640,000 in Q4-2016
Cash and short-term investments totalled $4.9 million as at December 31, 2017
2017 Full-Year Financial Highlights:

Revenue was $5.2 million, unchanged from $5.2 million in 2016
Net comprehensive loss was $2.7 million, compared to net comprehensive loss of $1.5 million over the same period last year
Adjusted EBITDA was ($1.4 million), compared to ($280,000) in 2016
Recent Operating Highlights:

Regained exclusive worldwide rights to develop and commercialize RIZAPORT
Received a Notice of Allowance from the United States Patent and Trademark Office for a formulation specific orange book eligible patent for Montelukast VersaFilm
Site obtained GMP compliant rating from Health Canada for manufacturing and packaging activities
Initiated Phase 2a proof of concept Montelukast VersaFilm clinical trial in Alzheimer’s patients
"2017 was an important year, as we continued down the path to clinical and commercial success," said Dr. Horst G. Zerbe, President and CEO of IntelGenx. "We have taken many important steps to support our efforts in pharmaceutical oral film development, manufacturing and commercialization, and remain on track for bringing our products to market. Moving forward, we believe that 2018 will represent a landmark period for IntelGenx, as we continue to advance our product pipeline, and begin clinical testing of our potentially groundbreaking Montelukast VersaFilm in Alzheimer’s patients."

Financial Results:

Total revenues for the three-month period ended December 31, 2017 amounted to $1.5 million, representing a decrease of $400,000 compared to $1.9 million for the three-month period ended December 31, 2016. The decrease is mainly attributable to upfront payments received in Q4-2016, partially offset by an increase in R&D revenues. Operating costs and expenses were $2.3 million for the fourth quarter of 2017, versus $1.5 million for the corresponding three-month period of 2016. For Q4-2017, the Company had an operating loss of $850,000, compared to operating income of $430,000 for the comparable period of 2016. Net comprehensive loss was $1.1 million, or $0.02 on a basic and diluted per share basis, for the fourth quarter of 2017, compared to net comprehensive loss of $22,000 or $0.00 on a basic and diluted per share basis, for the comparable period of 2016.

Total revenues for the twelve-month period ended December 31, 2017 amounted to $5.2 million, compared to $5.2 million for the twelve-month period ended December 31, 2016. Operating costs and expenses were $7.7 million for the full year 2017, versus $6.2 million for the corresponding 12-month period of 2016. For the twelve-month period of 2017, the Company had an operating loss of $2.5 million, compared to an operating loss of $980,000 for the comparable period of 2016. Net comprehensive loss was $2.7 million, or $0.04 on a basic and diluted per share basis, for the twelve-month period of 2017, compared to net comprehensive loss of $1.5 million, or $0.02 on a basic and diluted per share basis, for the comparable period of 2016.

As at December 31, 2017, the Company’s cash and short-term investments totalled $4.9 million, compared with $4.5 million as at December 31, 2016.

Annual Filings:

The Company’s annual report on Form 10-K and financial statements for the year ended December 31, 2017 as well as the 2018 Proxy Statement, will be filed with the United States Securities and Exchange Commission and the Canadian Securities regulatory authorities March 29, 2018 at 4:00 p.m. EDT.

Conference Call Details:

IntelGenx will host a conference call to discuss these 2017 fourth quarter and full year financial results March 29, 2018, at 4:30 p.m. EDT. The dial-in number for the conference call is (833) 211-3233 (Canada and United States) or (647) 689-3955 (International), conference ID 6786519. The call will be also be webcast live and archived for twelve months at www.intelgenx.com.