On January 7, 2020 AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, reported financial results for the second quarter of fiscal year 2020, which ended November 30, 2019 (Press release, AngioDynamics, JAN 7, 2020, View Source [SID1234552800]).

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"Sales growth of 2.5%, ex-Asclera, exhibited continued momentum during the quarter, and I am pleased with the resulting gross margin expansion and profitability," commented Jim Clemmer, President and Chief Executive Officer of AngioDynamics, Inc. "We are making excellent progress on the integration of Eximo Medical and are currently building out a dedicated commercial organization to support a product launch in the second half of our fiscal year 2020. I’m also excited to announce the acquisition of the C3 Wave tip location product, which will fill a technology gap in our portfolio and enable broader market adoption of our innovative BioFlo PICCs. Looking ahead, strong growth in sales of our AngioVac and NanoKnife products during the quarter should position us well to achieve our full-year guidance and drive growth across our portfolio."

Second Quarter 2020 Financial Results

Net sales for the second quarter of fiscal 2020, which now include the fiscal year 2019 acquisitions of BioSentry and RadiaDyne as organic revenue, were $70.0 million, flat compared to the prior-year quarter. Excluding the impact of Asclera sales, which were discontinued during fiscal year 2019, net sales grew 2.5% year over year. Foreign currency translation did not have a significant impact on the Company’s sales in the quarter.

Oncology net sales were $16.1 million, an increase of 5.1% from $15.3 million a year ago, led by higher sales of NanoKnife and the Alatus and IsoLoc balloon products.
Vascular Interventions and Therapies ("VIT") net sales were $31.2 million, an increase of 0.6%, compared to $31.0 million a year ago. Excluding last year’s Asclera sales of $1.7 million in the second quarter, VIT grew 6.5%, driven by growth in sales of the Company’s AngioVac and core VIT products.
Vascular Access net sales were $22.8 million, a decrease of 4.0% from $23.7 million a year ago, due primarily to lower sales of Ports and PICCs.
Excluding Asclera, U.S. net sales in the second quarter of fiscal 2020 were $55.6 million, an increase of 1.8% from $54.6 million a year ago, and International net sales were $14.4 million, an increase of 5.6% from $13.7 million a year ago.

Gross margin for the second quarter of fiscal 2020 was 59.3%, an increase of 140 basis points compared to the second quarter of fiscal 2019, driven primarily by productivity and supply chain improvements as well as positive product mix.

The Company recorded a net loss from continuing operations of $2.7 million, or a loss of $0.07 per share, in the second quarter of fiscal 2020. This compares to a net loss from continuing operations of approximately $3.6 million, or a loss of $0.10 per share, a year ago.

Excluding the items shown in the non-GAAP reconciliation table below, adjusted net income for the second quarter of fiscal 2020 was $2.2 million, or $0.06 per share, compared to adjusted net income of $2.9 million, or $0.07 per share, in the second quarter of fiscal 2019.

Adjusted EBITDA in the second quarter of fiscal 2020, excluding the items shown in the reconciliation table below, was $6.4 million, compared to $9.0 million in the second quarter of fiscal 2019.

In the second quarter of fiscal 2020, the Company used $5.9 million in operating cash and had capital expenditures of $2.6 million. As of November 30, 2019, the Company had $41.2 million in cash and cash equivalents and no debt outstanding.

Six Months Financial Results

For the six months ended November 30, 2019:

Net sales were $136.0 million, an increase of 1.6%, compared to $133.9 million for the same period a year ago. Excluding the impact of Asclera, sales of which were discontinued during fiscal year 2019, net sales grew 4.0% year over year.
The Company’s net loss from continuing operations was $4.0 million, or a loss of $0.11 per share, compared to a net loss from continuing operations of $9.3 million, or a loss of $0.25 per share, a year ago.
Gross margin improved 150 basis points to 58.6% from 57.1% a year ago.
Excluding the items shown in the non-GAAP reconciliation table below, adjusted net income was $5.3 million, or $0.14 per share, compared to adjusted net income of $3.6 million, or $0.09 per share, a year ago.
Adjusted EBITDA, excluding the items shown in the reconciliation table below, was $13.7 million, compared to $14.4 million for the same period a year ago.
C3 Wave PICC Tip Location Acquisition

Today, the Company announces the acquisition of the C3 Wave PICC tip location system from Medical Components Inc. This innovative, wireless, app-based ECG system eliminates the need for a confirmatory chest x-ray of PICC tip placement, allowing greater patient access to the Company’s proprietary BioFlo PICCs. The C3 Wave PICC tip location system has received FDA 510k, CE, Health Canada, and other international approvals.

Fiscal Year 2020 Financial Guidance

The Company reiterates its fiscal year 2020 guidance, which includes investments related to the full-market launch of the products acquired from Eximo anticipated in the second half of the fiscal year.

Specifically, the Company continues to expect net sales in the range of $280 to $286 million and gross margin in the range of 58% to 59%. Adjusted earnings per share is expected in the range of $0.10 to $0.15.

Conference Call

The Company’s management will host a conference call today at 8:00 a.m. ET to discuss its fiscal 2020 second quarter results.

To participate in the conference call, dial 1-877-407-0784 (domestic) or +1-201-689-8560 (international) and refer to the passcode 13697417.

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 Tuesday, January 7, 2020, until 11:59 p.m. ET on Tuesday, January 14, 2020. To hear this recording, dial 1-844-512-2921 (domestic) or +1-412-317-6671 (international) and enter the passcode 13697417.

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 EBITDA, adjusted net income, adjusted earnings per share, free cash flow and net sales excluding Asclera. 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 January 7, 2020 Bicycle Therapeutics plc (NASDAQ: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported a second collaboration with Cancer Research UK, the world’s largest independent funder of cancer research, in which Cancer Research UK will fund and sponsor development of BT7401, a multivalent Bicycle CD137 agonist, through a Phase IIa clinical study (Press release, Bicycle Therapeutics, JAN 7, 2020, View Source [SID1234552799]).

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"The modular nature of the Bicycle platform enables a number of opportunities to generate new therapeutics that could address unmet need in oncology and other serious diseases," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle. "This new collaboration marks yet another initiative designed to help us bring a potentially important Bicycle-based therapy to patients more efficiently. We are excited to extend our relationship with Cancer Research UK by collaborating with them on BT7401. Cancer Research UK is a partner of choice, with a broad network of collaborators and extensive expertise in cancer treatment. Through our collaboration, we believe we will be able to characterize the biologic and therapeutic profile of BT7401, which we’re pleased to add to our growing portfolio of novel immuno-oncology assets."

Dr. Nigel Blackburn, Cancer Research UK’s director of drug development, said: "We’re delighted to be partnering again with Bicycle, building on our continuing relationship. Based on the preclinical data, we believe that BT7401 could offer improved anti-tumor activity with fewer side effects compared with antibody-based approaches, which so far have been limited by toxicity."

Dr. Blackburn continued: "Looking to the future, we believe BT7401 has the potential to open up new treatment options for the large numbers of patients who stop responding to checkpoint inhibitors, and we look forward to working with Bicycle in this new endeavor."

BT7401 is a chemically synthesized, multivalent small molecule agonist of CD137, comprised of Bicycles connected by stable linkers through a central hinge. Though prior programs using antibodies to agonize CD137 have demonstrated robust and durable anti-tumor effects, they have been limited by severe hepatotoxicity observed in clinical trials. Preliminary toxicology studies suggest BT7401 may circumvent this limitation. In addition, BT7401 has shown significant pharmacologic activity in preclinical models. These findings indicate that BT7401 may offer an improved therapeutic index compared to that of antibody-based approaches.

Under the terms of the Clinical Development Partnerships agreement, Cancer Research UK’s Centre for Drug Development will fund and sponsor development of BT7401 from current preclinical studies through the completion of a Phase IIa trial. Bicycle retains the right to advance the BT7401 program further, at which point an undisclosed payment split between cash and equity, success-based milestones and royalty payments would be made to Cancer Research UK.

On January 7, 2020 PhoreMost Limited, the UK-based biopharmaceutical company dedicated to drugging ‘undruggable’ disease targets, reported it has entered into a multi-project drug discovery collaboration with Boehringer Ingelheim, one of the world-leading pharmaceutical companies developing innovative therapies for diseases with unsatisfactory treatments (Press release, PhoreMost, JAN 7, 2020, View Source [SID1234552798]). Under the terms of the agreement, PhoreMost will receive an upfront payment and research funding together with downstream success-based milestones. Further financial terms are not disclosed.

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PhoreMost will deploy its in-house expertise and next-generation phenotypic screening platform, SITESEEKER, towards disease relevant pathways nominated by Boehringer Ingelheim. Novel targets identified will be further validated and characterised by Boehringer Ingelheim as part of its internal Discovery Research pipeline. Boehringer Ingelheim’s Research programme is active in the fields of immunology and respiratory diseases, cardiometabolic diseases, oncology research and immuno-oncology, as well as diseases of the central nervous system.

The SITESEEKER platform is based on PhoreMost’s core proprietary protein interference, or ‘PROTEINi’, technology. Using SITESEEKER, PhoreMost probes the entire proteome in a live cell environment for novel druggable targets linked to any chosen disease, using the vast 3-D shape diversity of natural protein fragment (sub-domain) libraries. This enables the systematic unmasking of cryptic druggable sites, directly linking them to useful therapeutic functions.

Dr Chris Torrance, CEO of PhoreMost, said: "We are delighted that Boehringer Ingelheim has chosen to work with PhoreMost to enhance its drug discovery pipeline with attractive biological starting points. The collaboration is further recognition of the ability of PROTEINi and SITESEEKER to identify novel targets, and we look forward to working with the Boehringer Ingelheim team on these projects."

On January 7, 2020 Synaffix B.V., a biotechnology company focused on enabling antibody-drug conjugates (ADCs) with superior therapeutic index based on its proprietary ADC technologies, reported that Shanghai Miracogen Inc., a Chinese biotechnology company with a clinical-stage pipeline of ADCs, has expanded its existing collaboration by taking a license to develop and commercialize a second product candidate (Press release, Synaffix, JAN 7, 2020, View Source [SID1234552797]).

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Under the terms of the agreement, Miracogen has been granted non-exclusive rights to Synaffix’s proprietary GlycoConnect and HydraSpace ADC technologies for use in this second clinical candidate. Synaffix is eligible to receive upfront, milestone and royalty payments tied to this new program. Further financial details were not disclosed.

The original agreement was announced in April 2019, with Miracogen responsible for the research, development, manufacturing and commercialization of its ADC product, and Synaffix responsible for the manufacturing of components specifically related to its proprietary ADC technologies.

Peter van de Sande, CEO of Synaffix said:

"This expansion of our licensing agreement has resulted from the rapid and successful progression of Miracogen’s first ADC program with us and our strong working relationship. With six announced ADCs now under clinical or preclinical development based on Synaffix platform technologies, this expansion serves as further testament to the maturity of our proprietary ADC technologies.

"We look forward to continuing to work closely with Miracogen to develop innovative ADCs with enhanced therapeutic indexes for the treatment of cancer."

Mary Hu, CEO of Shanghai Miracogen added:

"Having worked with Synaffix over the past year and having seen highly positive results arising from the use of the GlycoConnect and HydraSpace technologies, we decided to expand the license agreement into a second ADC candidate. Using Synaffix’s platform, we hope to develop an additional ADC product candidate with an enhanced therapeutic index, and ultimately benefit cancer patients."

Notes to Editors

About GlycoConnect and HydraSpace

The clinical-stage GlycoConnect and HydraSpace technologies enable best-in-class ADCs with significantly enhanced efficacy and tolerability. GlycoConnect is the conjugation technology that exploits the native glycan for site-specific and stable payload attachment. HydraSpace is the compact and highly polar spacer technology. These technologies can be applied directly to any existing antibody without any protein sequence engineering and are compatible with all ADC payload classes.

The growing experience of Synaffix and its collaboration partners continues to confirm the ability of GlycoConnect and HydraSpace to consistently generate ADCs that are more effective and better tolerated when compared to the three major clinical-stage ADC conjugation technologies.

On January 7, 2020 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq:YMAB), a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported that Dr. Claus Møller, MD, Ph.D., Chief Executive Officer of Y-mAbs Therapeutics will provide an overview and update on the company’s business at the 38th Annual J.P. Morgan Healthcare Conference in San Francisco, California (Press release, Y-mAbs Therapeutics, JAN 7, 2020, View Source [SID1234552796]). The presentation will take place on Wednesday, January 15, 2020, at 4:30 PM Pacific Standard Time. The presentation can be accessed via a live webcast.

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