On September 27, 2018 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 first quarter of fiscal year 2019, which ended August 31, 2018 (Press release, AngioDynamics, SEP 27, 2018, View Source [SID1234529629]).

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"Our operating and financial accomplishments during the first quarter reflect our ongoing commitment to building a more cohesive, patient-focused product portfolio. As evidenced by our two recent acquisitions, we are making progress on our portfolio optimization efforts with a focus on the continuum of care within oncology, as well as on disruptive and differentiated technologies," commented Jim Clemmer, President and Chief Executive Officer of AngioDynamics, Inc. "Our first quarter results give us continued confidence in meeting our financial goals for fiscal 2019."

First Quarter 2019 Financial Results

Net sales for the first quarter of fiscal 2019 were $85.3 million, compared to $85.4 million a year ago. During the quarter, growth in the Company’s Vascular Access business was offset by declines in its Oncology business, while Vascular Interventions and Therapies (VIT) sales were flat.

Currency did not have a significant impact on the Company’s sales in the quarter.

Oncology net sales were $11.6 million, a decrease of 6.1% from $12.3 million a year ago, as NanoKnife disposable growth was more than offset by decreases in sales of Radiofrequency Ablation and timing effects of Microwave products. The comparison of year-over-year results within the Company’s Oncology business was negatively impacted by the timing of the prior-year Acculis Microwave abalation system market withdrawal. Excluding the impact of this transition from the Company’s Acculis Microwave product to its Solero Microwave product, the Oncology business grew 7.5% year over year.
VIT net sales in the first quarter of fiscal 2019 were $50.0 million, compared to $49.9 million a year ago, as growth in Fluid Management, Angiographic Catheters, and AngioVac was offset by declines in the Venous Insufficiency business.
Vascular Access net sales were $23.8 million, an increase of 2.4% from $23.2 million a year ago, as growth in Ports, Dialysis, and Midline products was partially offset by a decline in sales of PICCs.
U.S. net sales in the first quarter of fiscal 2019 were $67.7 million, a decrease of 1.8% from $68.9 million a year ago, and International net sales were $17.7 million, an increase of 7.1% from $16.5 million a year ago.

Gross margin for the first quarter of fiscal 2019 expanded 380 basis points to 52.1% from 48.3% a year ago, largely as a result of ongoing operational improvements, the recently completed facility consolidation, and the expiration of a royalty arrangement in the second quarter of fiscal 2018.

The Company recorded a net loss of $0.5 million, or $(0.01) per share, in the first quarter of fiscal 2019. This compares to a net loss of less than $100,000, or $0.00 per share, a year ago.

Excluding the items shown in the non-GAAP reconciliation table below, adjusted net income for the first quarter of fiscal 2019 was $6.2 million, or $0.16 per share, compared to adjusted net income of $5.0 million, or $0.13 per share, in the first quarter of fiscal 2018.

Adjusted EBITDAS in the first quarter of fiscal 2019, excluding the items shown in the reconciliation table below, was $12.6 million, compared to $11.3 million in the first quarter of fiscal 2018.

In the first quarter of fiscal 2019, the Company used $8.9 million in operating cash flow and had capital expenditures of $0.7 million. As of August 31, 2018, the Company had $24.8 million in cash and cash equivalents and $91.3 million in debt, excluding the impact of deferred financing costs.

Fiscal Year 2019 Financial Guidance

The Company is updating its previously announced financial guidance to reflect the BioSentry and RadiaDyne acquisitions, as well as the payment made to the DOJ for previously disclosed legal matters. The Company now expects 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 its 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 first 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 13683219.

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, September 27, 2018, until 11:59 p.m. ET on Thursday, October 4, 2018. To hear this recording, dial 1-844-512-2921 (domestic) or 1-412-317-6671 (international) and enter the passcode 13683219.

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 September 27, 2018 OncBioMune Pharmaceuticals, Inc. (OTCQB:OBMP) ("OncBioMune" or the "Company"), a clinical-stage biopharmaceutical company engaged in the development of a proprietary immunotherapy cancer vaccine technology and targeted cancer therapies, reported its update on the Phase 2 clinical trial of ProscaVax for early-stage prostate cancer (Press release, Oncbiomune, SEP 27, 2018, View Source [SID1234529910]). The Company is pleased to report that initial installments for the study have been made and the final preparations culminating in enrollment are being completed between Theradex Oncology, the Contract Research Organization overseeing the study, and the host hospital, Beth Israel Deaconess Medical Center, a teaching hospital of Harvard University Medical School in Boston, MA.

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ProscaVax is OncBioMune’s lead immunotherapy platform candidate consisting of a combination of prostate cancer associated prostate specific antigen (PSA) with the biological adjuvants interleukin-2 (IL-2) and granulocyte-macrophage colony-stimulating factor (GM-CSF). Per study protocol, approximately 120 patients are expected to be enrolled. The patients will be in what is termed "active surveillance," a disease management option for patients with localized prostate cancer that elect to work with their doctor to monitor the disease for progression before taking more drastic intervention measures, such as surgery or radiotherapy. To the Company’s knowledge, the trial of ProscaVax is the first ever worldwide for a prostate cancer vaccine technology addressing the active surveillance patient population.

"Our excitement is growing as we draw closer to enrollment. We (our Company and the host hospital) have already fielded inquiries from prostate cancer patients interested in participating in the study, which is an encouraging sign about recruitment once the trial is opened," commented Dr. Jonathan Head, Chief Executive Officer at OncBioMune. "We think the interest is owed to the strong safety profile and meaningful immunological effect demonstrated in the Phase 1 study of ProscaVax in advanced-stage prostate cancer patients and the simple fact that there are no FDA-approved therapeutic options for the tens of thousands of active surveillance patients that want to be proactive in addressing their cancer. We believe that ProscaVax has a lot to offer these patients and potential future partners as the only vaccine of this type."

In preparation for the trial and other pipeline developments, the Company has taken measures to clean its balance sheet, including recently retiring $900,000 in convertible, floorless debt. Management is currently in negotiations with its lenders and accredited investors to secure additional funding structured under attractive terms, including preferred stock and fixed-rate convertible debentures.

About Prostate Cancer

According to the American Cancer Society (ACS), prostate cancer is the most common type of cancer in men other than skin cancer, with about 1 in 9 men diagnosed during their lifetime. ACS estimates that about 164,690 new cases of prostate cancer will be diagnosed during 2018 and approximately 29,430 men will die from the disease this year. Prostate cancer is the second leading cause of cancer death in men, trailing only lung cancer. Approximately 2.9 million men are living with prostate cancer today. The average age of diagnosis is 66, with the disease considered rare in men under the age of 40.

On September 27, 2018 2A Pharma is reported that we have been granted SEK 3M Eurostars funding for 2AP07 , a project to develop a therapeutic head and neck cancer vaccine in collaboration with The Danish Technological Institute and Danish biotech company DNA Sense (Press release, 2A Pharma, SEP 27, 2018, View Source [SID1234530716]).

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Head and neck cancers represents the sixth most common cancer worldwide, resulting in more than 350,000 deaths/year. Our AAVLP-HNC vaccine has the potential to minimize side effects, improve efficacy, and markedly reduce treatment costs. This will address an unmet medical need and benefit cancer patients as well as reduce healthcare expenses. In addition, our combination of advanced technologies will establish a versatile platform for developing further vaccines.

On September 27, 2018 FLX Bio, Inc., a clinical-stage, biopharmaceutical company focused on the development of oral small-molecule drugs that target drivers of cancer and other immune-related disorders, reported that the first patient has been treated in its Phase 1/2 clinical trial of FLX475 in patients with various advanced cancers (Press release, FLX Bio, SEP 27, 2018, View Source [SID1234529630]). FLX475 is an oral, small molecule CCR4 antagonist that selectively inhibits migration of regulatory T (Treg) cells into the tumor microenvironment.

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"The dosing of our first patient with FLX475 is a significant milestone for FLX Bio as we continue to advance our novel therapeutic approach targeting the tumor microenvironment," said Brian Wong, M.D., Ph.D., CEO of FLX Bio. "Treg cells play fundamental roles in inhibiting the immune response to the tumor and are a major resistance mechanism to many cancer immunotherapies including PD-1 inhibitors. FLX475 represents a best-in-class approach to selectively decrease Treg numbers in the tumor thereby unlocking the antitumor immune response. In addition, our big data and proprietary informatics platform has revealed the tumor types most likely to respond to FLX475. We are excited to evaluate this new therapeutic modality in these enriched patient populations through our ongoing global Phase 1/2 clinical trial."

"FLX475 has demonstrated an excellent safety, pharmacokinetic and pharmacodynamic profile in a recently-completed study of healthy volunteers and we believe this compound holds tremendous promise for directly addressing the suppressive effects of Treg in the tumor microenvironment," said Bill Ho, M.D., Ph.D., Chief Medical Officer of FLX Bio. "Treatment with FLX475 should allow the selective blocking of tumor-associated Treg recruitment while sparing normal tissues and beneficial cells. This may offer a safer and more efficacious treatment alternative for patients with many different types of cancer, as compared to the several existing strategies used to suppress or deplete Treg cells."

The open-label, dose-escalation and cohort expansion Phase 1/2 study will enroll patients with multiple types of cancer at leading cancer centers across the United States, Australia and Asia. The trial will evaluate the safety and tolerability of FLX475 as a monotherapy and in combination with pembrolizumab. In addition, the study will evaluate changes in the tumor microenvironment and the antitumor activity of both monotherapy and combination therapy. Patients with tumors positive for the Epstein-Barr Virus (EBV), which has been shown to be an indicator of tumors with a higher number of Treg cells, will be enrolled in a biomarker-selected cohort. Tumors that can be positive for EBV include nasopharyngeal cancer and Hodgkin lymphoma. In addition, the company intends to enroll patients with tumors that express high levels of CCR4 receptor and ligands, which include non-small cell lung cancer, head and neck cancer, triple negative breast cancer, and cervical cancer. For more information please visit clinicaltrials.gov identifier NCT03674567.

About FLX475

FLX475 is a best-in-class oral, small molecule antagonist of CCR4. FLX Bio has completed a study of FLX475 in healthy volunteers, demonstrating that the compound is safe with excellent pharmacokinetic and pharmacodynamic properties. In preclinical studies, FLX475 inhibited tumor growth and increased tumor regression as a single agent. In addition, FLX475 enhanced the antitumor effects of various checkpoint inhibitors including anti-PD-L1 and anti-CTLA4 antibodies as well as immune agonists such as anti-4-1BB antibodies. FLX475 also has the potential to enhance cell-based immunotherapies such as CAR-T and cancer vaccines. Unlike antibodies to CCR4, FLX475 selectively blocks the recruitment of regulatory T cells to the tumor site and does not deplete cells beneficial to an antitumor response or regulatory T cells in healthy tissue such as blood, spleen and skin cells.

On September 27, 2018 Genprex, Inc. (NASDAQ:GNPX), a clinical stage gene therapy company developing a new approach to treating cancer based upon a novel proprietary technology platform, reported that it has signed an agreement with Aldevron, a leading contract manufacturing organization, to supply TUSC2 (Tumor Suppressor Candidate2) plasmid DNA for use in Genprex’s clinical development program evaluating its immunogene therapy Oncoprex for the treatment of non-small cell lung cancer (Press release, Genprex, SEP 27, 2018, View Source [SID1234529631]).

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"Plasmid DNA plays an important role in the delivery of gene therapies into target cells," said Rodney Varner, Chairman and Chief Executive Officer of Genprex. "Aldevron is a leading plasmid manufacturer that offers world-class laboratory and manufacturing programs. Through this agreement, we have established a GMP-validated supply of plasmid DNA vectors for our expanding clinical program evaluating the utility of Oncoprex in combination with some of the most promising new therapies for cancer."

"Aldevron is honored to partner with Genprex in the development of Oncoprex," said Michael Chambers, CEO of Aldevron. "This collaboration furthers our goal to provide high-quality plasmid DNA and other biologics to leading companies such as Genprex that are creating treatments that could have a significant impact on human health."