On April 2, 2019 Fusion Pharmaceuticals, a clinical-stage biopharmaceutical company developing targeted alpha-particle radiotherapeutics for treating cancer, reported the completion of a $105 million Series B financing led by Varian and new investor OrbiMed (Press release, Fusion Pharmaceuticals, APR 2, 2019, View Source [SID1234534923]).

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Additional investors participating in the round are Perceptive Advisors, Pivotal bioVenture Partners, and Rock Springs Capital, along with the existing group of leading international investors, that include HealthCap, Adams Street Partners, Johnson & Johnson Innovation – JJDC, Inc. (JJDC), TPG Biotech, Seroba Life Sciences, Genesys Capital, and FACIT.

In conjunction with the new financing, Deepak Khuntia, Senior Vice President (SVP) and Chief Medical Officer (CMO) at Varian, Chau Q. Khuong, Partner at OrbiMed, and Heather Preston, Managing Director at Pivotal bioVenture Partners, will join Fusion’s Board of Directors.

The financing will be used to advance and broaden the scope of Fusion’s ongoing clinical program in targeted alpha therapeutics, and accelerate a pipeline of new radiopharmaceuticals and combination therapy strategies. The company’s lead product candidate [225Ac]-FPI-1434, combines the precision targeting of an antibody with the potency of alpha-particle emitting medical isotopes to specifically attack and eradicate cancer cells across multiple tumor types.

"Fusion is delighted to welcome this group of preeminent healthcare investors to our existing and highly distinguished series A investors. We have made tremendous progress in the last two years, and this financing reflects strong support for our platform, people and pipeline," said John Valliant, Ph.D., Fusion’s Chief Executive Officer. "The investment positions us to implement our clinical and partnering strategies around [225Ac]-FPI-1434, expand our team and fully exploit the unique advantages of our linker technology."

Fusion’s proprietary Fast-Clear Linker Technology Platform promotes the rapid excretion of medical isotopes that are not specifically bound to cancer cells. The Fast-Clear Linker (the "connector" between a molecule and a medical isotope) is engineered to clear medical isotopes at a faster rate, compared to traditional technologies, with the aim of expanding the therapeutic window. Given the power and versatility of the Fast-Clear Platform, Fusion is applying this technology to different classes of molecules.

"We were attracted to Fusion by the excellent science, broad patient applicability, and great promise for its targeted alpha therapeutics, which have the potential to eradicate even the most resistant types of cancer," said Deepak Khuntia, SVP, CMO, at Varian. "The investment will enable Fusion to advance a pipeline of novel therapeutics that can deliver effective and personalized radiation therapies to cancer patients."

"OrbiMed is excited to co-lead the financing of Fusion, which is the industry leader in targeted alpha therapeutics. Fusion has a unique platform and an exciting lead program in early stage clinical trials that holds promise for improving the lives of cancer patients," said Chau Q. Khuong, Partner at OrbiMed. "There is significant re-emerging commercial interest in radiopharmaceuticals given recent advances in the field and Fusion is at the forefront. We are excited to work with the Fusion team to meet the aggressive goals of the company."

On April 2, 2019 Novocure (NASDAQ:NVCR) reported that it will report financial results for the first quarter 2019 on Thursday, May 2, 2019, before the U.S. financial markets open (Press release, NovoCure, APR 2, 2019, View Source [SID1234534922]). Novocure management will host a conference call and webcast to discuss its financial results for the three months ended March 31, 2019, at 8 a.m. EDT on Thursday, May 2, 2019.

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Analysts and investors can participate in the conference call by dialing 855-442-6895 for domestic callers and 509-960-9037 for international callers, using the conference ID 8956998. The webcast and earnings slides presented during the webcast can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for replay for at least 14 days following the call.

On April 2, 2019 AVEO Oncology (NASDAQ: AVEO) reported that Michael Bailey, president and chief executive officer, will present at the H.C. Wainwright Global Life Sciences Conference in London on Tuesday, April 9, 2019 at 2:10 p.m. BST (Press release, AVEO, APR 2, 2019, View Source [SID1234534921]).

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A live webcast of the presentation can be accessed by visiting the investors section of the Company’s website at www.aveooncology.com. A replay of the webcast will be archived for 30 days following the presentation date.

On April 2, 2019 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 third quarter of fiscal year 2019, which ended February 28, 2019 (Press release, AngioDynamics, APR 2, 2019, View Source [SID1234534920]).

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"While we had pockets of softness in our financial performance during the third quarter, our overall performance remains strong, and we are confident that we will achieve our full-year guidance. We saw strong growth contributions during the quarter from AngioVac and Solero, as well as from Fluid Management," commented Jim Clemmer, President and Chief Executive Officer of AngioDynamics, Inc. "Additionally, I am very excited that the FDA has approved the IDE for our NanoKnife DIRECT Clinical Study, which is the next step toward this incredible technology improving the standard of care for patients afflicted with Stage III pancreatic cancer. The IDE approval also represents a milestone for AngioDynamics as we transform into an evidence-based Company focused on therapies and outcomes facilitated by our unique technologies."

Third Quarter 2019 Financial Results

Net sales for the third quarter of fiscal 2019 were $86.3 million, an increase of 3.0%, compared to $83.9 million a year ago. Foreign currency translation did not have a significant impact on the Company’s sales in the quarter.

Oncology net sales were $13.9 million, an increase of 15.1% from $12.1 million a year ago, as strong sales of Solero, as well as the recent BioSentry and RadiaDyne acquisitions, more than offset weaker than anticipated NanoKnife capital sales during the quarter.
Vascular Interventions and Therapies net sales in the third quarter of fiscal 2019 were $50.1 million, an increase of 3.3%, compared to $48.5 million a year ago, as strong growth in AngioVac was partially offset by a decelerating decline in the Venous Insufficiency business.
Vascular Access net sales were $22.3 million, a decrease of 4.0% from $23.3 million a year ago, as lower sales of midlines, PICCs, and ports were somewhat offset by strong dialysis sales.
U.S. net sales in the third quarter of fiscal 2019 were $68.3 million, an increase of 3.9% from $65.8 million a year ago, and International net sales were $18.0 million, a decrease of 0.3% from $18.1 million a year ago.

Gross margin for the third quarter of fiscal 2019 declined 10 basis points to 54.1% from 54.2% a year ago. This reflects temporary headwinds related to FX and a one-time positive impact from plant closures recognized last year. The Company continues to see gains in gross margin related to operational and supply-chain improvements.

The Company recorded net income of $0.8 million, or $0.02 per share, in the third quarter of fiscal 2019. This compares to net income of approximately $14.0 million, or $0.37 per share, a year ago.

Excluding the items shown in the non-GAAP reconciliation table below, adjusted net income for the third quarter of fiscal 2019 was $7.4 million, or $0.19 per share, compared to adjusted net income of $8.7 million, or $0.23 per share, in the third quarter of fiscal 2018.

Adjusted EBITDAS in the third quarter of fiscal 2019, excluding the items shown in the reconciliation table below, was $14.9 million, compared to $16.8 million in the third quarter of fiscal 2018.

In the third quarter of fiscal 2019, the Company generated $8.3 million in operating cash flow and had capital expenditures of $0.9 million. As of February 28, 2019, the Company had $41.7 million in cash and cash equivalents and $133.8 million in debt, excluding the impact of deferred financing costs.

Nine Months Financial Results

For the nine months ended February 28, 2019:

Net sales were $263.2 million, an increase of 2.8%, compared to $256.0 million for the same period a year ago.
The Company’s net income was $2.5 million, or $0.06 per share, compared to net income of $14.2 million, or $0.38 per share, a year ago.
Gross margin improved 270 basis points to 53.3% from 50.6% a year ago.
Excluding the items shown in the non-GAAP reconciliation table below, adjusted net income was $22.0 million, or $0.57 per share, compared to adjusted net income of $19.9 million, or $0.53 per share, a year ago.
Adjusted EBITDAS, excluding the items shown in the reconciliation table below, was $43.9 million, compared to $41.5 million for the same period a year ago.
Fiscal Year 2019 Financial Guidance

The Company reiterates its previously announced financial guidance, continuing to expect fiscal year 2019 net sales in the range of $354 to $359 million and free cash flow in the range of $26 to $31 million. Additionally, the Company continues to expect adjusted earnings per share in the range of $0.82 to $0.86.

Conference Call

The Company’s management will host a conference call today at 8:00 a.m. ET to discuss its third quarter 2019 results.

To participate in the conference call, dial 1-877-407-0784 (domestic) or 1-201-689-8560 (international) and refer to the passcode 13688664.

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, April 2, 2019, until 11:59 p.m. ET on Tuesday, April 9, 2019. To hear this recording, dial 1-844-512-2921 (domestic) or 1-412-317-6671 (international) and enter the passcode 13688664.

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 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 April 2, 2019 MiNA Therapeutics, the pioneer in RNA activation (RNAa) therapeutics, reported pre-clinical data supporting the immunological effects of MTL-CEBPA and its benefits in combination with other anti-cancer interventions including sorafenib, anti-PD1 checkpoint inhibition and radiofrequency ablation (Press release, MiNA Therapeutics, APR 2, 2019, View Source [SID1234534919]). The data will be presented today in two posters at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place in Atlanta, Georgia.

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"With these additional pre-clinical studies, we continue to elucidate the benefits that our lead candidate MTL-CEBPA can provide not only alone but also in combination to improve standard of care treatments," said Robert Habib, CEO of MiNA Therapeutics. "We look forward to sharing these results with the scientific community at AACR (Free AACR Whitepaper) which support our ongoing clinical investigation of MTL-CEBPA in severe liver cancer patients."

The first pre-clinical study highlights that the combination of MTL-CEBPA with sorafenib resulted in superior tumour growth inhibition and reduction of tumour biomarker alpha-fetoprotein (AFP) compared to single agents as demonstrated in an immunocompetent rat model of hepatocellular carcinoma. The anti-tumour activity of sorafenib had previously been demonstrated to be enhanced by immunological agents targeting suppressive myeloid cells in the tumour microenvironment. In the presented study, the combination of MTL-CEBPA and sorafenib was administered in a sequential regimen to "prime" tumours with MTL-CEBPA before treating with sorafenib. Most importantly, the results further support the expansion of MiNA’s Phase 1b OUTREACH trial to evaluate MTL-CEBPA in combination with sorafenib.

A second pre-clinical study describes a triple combination of MTL-CEBPA with anti-PD1 checkpoint inhibition and radiofrequency ablation in an immunocompetent mouse model of liver cancer bearing tumours on two opposite flanks. Radiofrequency ablation was performed on one flank only and treatment effects were assessed on the contralateral flank. Compared to single agent or double combinations, the triple combination demonstrated significantly improved immunological responses as well as anti-tumour activity. Immunological responses in the tumour microenvironment were evidenced by superior infiltration of cytotoxic T lymphocytes (TILs) as well as natural killer T (NKT) cells. Anti-tumour activity was evidenced by near complete inhibition of tumour growth including complete responses. Improved tumour growth inhibition in the contralateral flank suggested that the combination of MTL-CEBPA and anti-PD1 checkpoint inhibition increased the effectiveness of the abscopal effects of radiofrequency ablation.

The posters will be made available on the Company’s website in the Publications section under "RNA Activation".

Presentation information

Title: MTL-CEBPA, a drug candidate for hepatocellular-carcinoma enhances efficacy of sorafenib
Abstract No: 4455
Session: Experimental and Molecular Therapeutics – Novel Antitumor Agents 2
Date / time: Tuesday April 2, 2019 from 1:00 pm to 5:00 pm CDT

Title: MTL-CEBPA combined with radiofrequency ablation and immunotherapy enhances immunological anti-tumour response in an HCC mouse model
Abstract No: 4224
Session: Immunology – Combination Immunotherapies 2
Date / time: Tuesday April 2, 2019 from 8:00 am to 12:00 pm CDT
About MTL-CEBPA

MTL-CEBPA consists of a double stranded RNA formulated in a liposomal nanoparticle and is designed to activate the CEBPA gene. The CEBPA gene encodes CCAAT/enhancer binding protein alpha (C/EBP-α), a transcription factor that acts as a master regulator of cell lineage determination and differentiation in several tissues including myeloid cells, liver cells and adipose tissue. In cancer, C/EBP-α plays important roles in regulating both tumour growth and the tumour immune microenvironment. MTL-CEBPA is currently under evaluation in OUTREACH, a Phase Ib clinical study in patients with advanced liver cancer. The multi-centre study is assessing the safety, tolerability and anti-tumour activity of MTL-CEBPA in combination with sorafenib. To learn more about the OUTREACH clinical study, please visit our listing at clinicaltrials.gov