On March 29, 2018 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage immunotherapeutics company, reported financial results for the year ended December 31, 2017 (Press release, Altimmune, MAR 29, 2018, View Source [SID1234525052]).

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Corporate Highlights

Enrolled first two cohorts of government funded Phase 1 trial of NasoShield, an intranasal vaccine against anthrax infection

Positive data in two Phase 2 clinical programs:

Announced positive proof-of-concept Phase 2 flu vaccine trial results with our NasoVAX vaccine

Announced positive pre-clinical data from the Company’s SparVax-L trial comparing SparVax-L and BioThrax against anthrax infection

Extended its IP protection of NasoShield in the U.S. with a Notice of Allowance from the U.S. Patent Office

Elected Mitchel Sayare, Ph.D., as Chairman of its Board of Directors

Raised approximately $30 million in financing, including through a Series B preferred offering, cash acquired in connection with the reverse merger with PharmAthene and a pre-merger private placement with existing investors, providing cash into the first quarter of 2019
"We have had a very data-rich few weeks with results being reported from our NasoVAX, HepTcell, and SparVax-L programs and moving forward on enrollment in our Phase 1 trial of NasoShield," said William J. Enright, Chief Executive Officer of Altimmune. "We are very excited by the positive results from our NasoVAX trial and look forward to continuing to advance that program. NasoVAX is a very different type of flu vaccine that has tremendous potential as an effective, easy-to-use vaccine that potentially provides better protection than current vaccines. We are also excited by the results on our SparVax-L trial and look forward to moving that program forward once we secure additional government funding. We continue to evaluate our HepTcell results will update investors on our next steps as we better understand those results."

Mr. Enright continued, "operationally, we are pleased with our progress. In 2017 we closed the reverse merger with PharmAthene, allowing us to leverage our resources and create a focused immunotherapeutics company. We strengthened our scientific team with the promotion of Dr. Sybil Tasker to Chief Medical Officer in early 2017. Additionally, in January 2018, Mitchel Sayare, Ph.D. was elected as Chairman of our Board of Directors bringing in-depth biotechnology experience as the former CEO of Immunogen. We anticipate continuing to build on our momentum in 2018 as we move forward with our NasoVAX, SparVax-L and NasoShield programs."

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Financial Results for the Year Ended December 31, 2017

Revenue for the year ended December 31, 2017 was $10.7 million compared to $3.2 million for 2016. The increase was due to $5.7 million increase in revenue from our contract with BARDA and $1.8 million revenue from the NIAID contract we assumed from our merger with PharmAthene in May 2017.

Research and development expenses were $18.4 million for the year ended December 31, 2017 compared to $7.2 million for 2016. The increase in research and development expenses was primarily the result of increases relating to NasoShield, NasoVAX, HepTcell, and SparVax-L clinical and preclinical trial costs, partially offset by $0.5 million reduced spending on the Oncosyn program. Research and development expenses for the year ended December 31, 2016 did not include PharmAthene or costs incurred under the NIAID contract.

General and administrative expenses were $8.5 million for the year ended December 31, 2017, compared to $7.1 million for 2016. The increase was the combined result of increased professional fees related to the merger with PharmAthene and costs incurred by us as a public company, including insurance costs and stock compensation expense, offset by $2.4 million of costs related to our initial public offering incurred in 2016 that did not recur in 2017.

We determined that our goodwill was impaired and a non-cash goodwill impairment charge of $35.9 million was recorded during the year ended December 31, 2017 which was classified as a component of operating expenses. The non-cash charge resulted from our goodwill assessment based on our market capitalization plus an implied control premium relative to the carrying value of our net assets. The non-cash charge has no effect on our current cash balance or operating cash flows.

We recorded an income tax benefit of $5.6 million during the year ended December 31, 2017, which reflected estimated tax refunds we expect to receive from carrying back our 2017 net operating losses to offset the 2016 federal and state income taxes paid by PharmAthene.

Net loss attributable to common stockholders for the year ended December 31, 2017 was $51.4 million compared with $11.5 million for 2016. Excluding the non-cash goodwill impairment charges, net loss attributable to common stockholders for the year ended December 31, 2017 was $15.4 million compared to $11.5 million for 2016.

Net loss per share attributable to common stockholders for the year ended December 31, 2017 was ($4.01) compared with ($1.66) for 2016. Excluding the non-cash goodwill impairment charges, net loss per share attributable to common stockholders for the year ended December 31, 2017 was ($1.21), compared to ($1.66) for 2016.

At December 31, 2017, the Company had cash, cash equivalents, and restricted cash of approximately $12.3 million, of which $3.5 million was restricted under the terms of the Series B preferred offering.

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Non-GAAP Measures

To supplement the Company’s unaudited financial statements presented in accordance with generally accepted accounting principles ("GAAP"), this press release includes a discussion of adjusted net loss attributable to common stockholders and adjusted net loss per share attributable to common stockholders, in each case adjusted for the loss due to a goodwill impairment charge. The Company believes that these non-GAAP measures, when taken into consideration with the corresponding GAAP financial measures, provide investors with meaningful comparisons of current results to prior period results by excluding items that the Company does not believe reflect its fundamental business performance. See the attached schedule for a reconciliation of net loss to adjusted net loss and loss per share to adjusted loss per share for the twelve months ended December 31, 2017 and 2016.

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

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]).

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"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.

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]).

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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.

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]).

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"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