On March 29, 2018 Kazia Therapeutics Limited (ASX: KZA; NASDAQ: KZIA), an Australian oncology drug development company, reported that commencement of an international phase II clinical trial of its lead program, GDC-0084 (Press release, Kazia Therapeutics, MAR 29, 2018, View Source [SID1234526004]).

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Key Points
• First site, Stephenson Cancer Center at the University of Oklahoma, has been initiated and will begin screening patients after the Easter holidays
• Study commencement follows a successful meeting with US Food & Drug Administration (FDA) in September 2017, and approval by Western Institutional Review Board in November 2017
• Initial focus will be on dose optimization in the treatment of newly-diagnosed patients with glioblastoma multiforme; adaptive study design will then seek to provide definitive evidence of clinical efficacy

GDC-0084 is being developed for glioblastoma multiforme (GBM), the most common and most aggressive form of primary brain cancer. The mainstay of current pharmacological treatment, temozolomide, is effective only in about one third of patients, and median survival is approximately 12 to 15 months from diagnosis.

Kazia licensed GDC-0084 in late 2016 from Genentech, a member of the Roche Group, where it had previously completed a phase I clinical study in 47 patients with advanced glioma.

Genentech’s phase I study demonstrated a favourable safety profile and provided signals of efficacy. Genentech also conducted an extensive preclinical program which showed encouraging results for GDC-0084 in animal models of glioblastoma.

Kazia CEO, Dr James Garner, commented, "the entire team has been working hard to design and implement the GDC-0084 clinical study. We are very pleased to now have the trial underway, and look forward to working with the participating clinicians. The need for new therapies in this disease remains immense, and we believe that GDC-0084 may have a valuable role to play in improving outcomes for patients with glioblastoma."

This phase II study will initially be conducted predominantly at leading US-based centres, in collaboration with specialist clinicians in the neuro-oncology field, and under an Investigational New Drug (IND) filing with the US Food and Drug Administration. The study is awaiting registration with clinicaltrials.gov, and will commence screening patients after the Easter holidays. Not all patients will qualify, and some may withdraw during the initial phase
of the study. It is anticipated that the study will provide an initial data read-out in early calendar 2019.

A video interview of Dr James Garner discussing the clinical study can be accessed via the
Kazia corporate website at View Source

The Company has also prepared an animation to explain the activity of GDC-0084, and this can be accessed via the
Kazia corporate website at View Source

Commencement of the trial follows the decision of the US FDA to grant orphan drug designation to GDC-0084 in glioblastoma in February 2018. Since in-licensing the program, Kazia has been working closely with clinicians and advisors to build a comprehensive development program which aims to move GDC-0084 towards a product registration in the swiftest and most effective way. To date, this has included extensive regulatory consultation,
manufacture of drug product for use in the phase II clinical trial, optimization of the intellectual property portfolio, and implementation of additional animal studies to support the further development of the drug.

Kazia Chairman, Iain Ross, commented, "this is an important achievement for the organisation. Two years ago, Kazia was an early-stage preclinical company. We now have two high-quality assets in clinical trials: Cantrixil in phase I for ovarian cancer and GDC-0084 in phase II for glioblastoma. The Board and Management have completed a significant
transformation of the organization so as to optimally support this clinical-stage portfolio, and we are now a lean, cost-effective, and highly-focused biotech."

He added, "we continue to be pleased with progress on the phase I study of Cantrixil, and look forward to reporting initial data from this study, which we expect will occur in the second calendar quarter of 2018."

(Filing, Annual, InflaRx, 2017, MAR 29, 2018, View Source [SID1234527582])

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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

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 -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.