On January 7, 2020 Boundless Bio, a company interrogating and targeting extrachromosomal DNA (ecDNA) in aggressive cancers, reported presentations at the following upcoming conferences (Press release, Boundless Bio, JAN 7, 2020, View Source [SID1234552804]):

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2020 CTIC Pre-JPM 4th Healthcare Investment Summit: Scott Moorefield, Ph.D., Chief Business Officer of Boundless Bio, will give a company overview on Sunday, January 12, 2020, from 5:05 p.m. – 5:20 p.m. PST.
Precision Medicine World Conference: Jason Christiansen, Ph.D., Chief Technology Officer of Boundless Bio, will give a presentation titled: "Targeting Extrachromosomal DNA (ecDNA), A New Approach To Targeting Cancers With High Copy Number Amplification." The presentation will take place during the Emerging Therapeutics Showcase on January 24, 2020, at 2:15 p.m. PST.
About ecDNA

Extrachromosomal DNA, or ecDNA, are large circles of DNA containing genes that are outside the cells’ chromosomes and can make many copies of themselves. ecDNA can be rapidly replicated within the cell, causing high numbers of oncogene copies, a trait that can be passed to daughter cells in asymmetric ways during cell division. Cells have the ability to upregulate or downregulate ecDNA and resulting oncogenes to ensure survival under selective pressures, including chemotherapy or radiation, making ecDNA one of cancer cells’ primary mechanisms of recurrence and treatment evasion. ecDNA are rarely seen in healthy cells but are found in many solid tumor cancers. They are a key driver of the most aggressive and difficult-to-treat cancers, specifically those characterized by high copy number amplification of oncogenes.

On January 7, 2020 ImmunityBio, a privately held immunotherapy company focused on developing a T-cell memory cancer vaccine, reported that Patrick Soon-Shiong, M.D., Chairman and Chief Executive Officer, will present at the 38th Annual J.P. Morgan Healthcare Conference on Tuesday, January 14, 2020 at 11:00 a.m. Pacific Time (Press release, ImmunityBio, JAN 7, 2020, View Source [SID1234552803]). The event will be held at the Westin St. Francis in San Francisco.

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Dr. Soon-Shiong will present clinical updates and the registration strategy of the combination therapy of NantKwest’s off-the-shelf NK therapy with ImmunityBio’s N-803 molecule, as well as discuss the future relationship between the two companies’ immunotherapy platforms.

A live audio webcast of the conference presentation will be available on the ImmunityBio and NantKwest websites, immunitybio.com and NantKwest.com. An archived replay will be available on the websites for approximately 30 days.

On January 7, 2020 BioMarker Strategies, LLC, reported that the National Cancer Institute (NCI) has awarded the Company a Phase II Small Business Innovation Research (SBIR) contract to continue development of its PathMAP Immunotherapy test to predict clinical response to PD-1/PD-L1 targeted immune checkpoint inhibitors, both alone and in combination with chemotherapies, for individual patients with non-small cell lung cancer (NSCLC) (Press release, BioMarker Strategies, JAN 7, 2020, View Source [SID1234552802]). The contract totals $1.5 million over two years.

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The Phase II contract follows a Phase I contract that supported development of initial proof-of-concept data for PathMAP Immunotherapy as a pathway-based test to identify patients who could otherwise be excluded from treatment with these very important therapies, because currently available tests show them as negative for the biomarkers currently used to identify patients who might benefit.

"Durable responses have been observed in patients with non-small cell lung cancer who have received treatment with immune checkpoint inhibitors, which enable the immune system to kill tumors," said Jerry Parrott, President and CEO of BioMarker Strategies. "However, the reality is that the objective response rate to single-agent immunotherapy is low, at 10-30%. And, the emergence of resistance is observed in patients who initially respond, just as is observed with chemotherapies. This Phase II SBIR contract from NCI will enable us to continue development of our PathMAP Immunotherapy test to predict individual patient response to checkpoint inhibitors, both alone and in combination with chemotherapies."

This project is funded in whole or in part with Federal funds from the National Cancer Institute, National Institutes of Health, Department of Health and Human Services, under Contract No. 75N91019C00022.

Lung cancer is the leading cause of cancer death in the United States, with an estimated 154,000 deaths in 2018. NSCLC is responsible for more than 80% of these deaths.

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.