BostonGene Announces Acceptance of Six Abstracts to be Presented at the American Association for Cancer Research Annual Meeting 2022

On April 7, 2022 BostonGene reported that six abstracts were selected for poster presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022, which will be held from April 8 – 13, 2022, at the Ernest N. Morial Convention Center in New Orleans, Louisiana. In addition, BostonGene will exhibit at booth #3641 (Press release, BostonGene, APR 7, 2022, View Source [SID1234611607]).

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The presentations describe BostonGene’s development of novel analytical tools and demonstrate results of work conducted with multiple leading cancer centers in the United States. The findings highlight the application of BostonGene’s cutting-edge technologies to improve the diagnosis and treatment of cancer patients.

"We look forward to showcasing our research at the AACR (Free AACR Whitepaper) Annual Meeting. Our findings underscore the clinical utility of BostonGene‘s deep molecular and immune profiling and analytics to advance precision medicine for cancer patients," said Nathan Fowler, MD, Chief Medical Officer at BostonGene.

Details of the poster presentations are below:

Title: 1216 / 12 – Combinatory technologies for single sample gene expression projection onto a cohort sequenced with a different technology for personalized clinical decision-making
Session: PO.BCS01.01. New Algorithms and Tools for Data Analysis
Date and Time: Monday, April 11 | 9:00 AM – 12:30 PM
Location: Exhibit Halls D-H, Poster Section 29
Presenter: Krystle Nomie, PhD, BostonGene

Title: 1227 / 23 – Molecular-based tumor grade predictor for breast cancer, clear cell renal cell carcinoma, and lung adenocarcinoma
Session: PO.BCS01.01. New Algorithms and Tools for Data Analysis
Date and Time: Monday, April 11 | 9:00 AM – 12:30 PM
Location: Exhibit Halls D-H, Poster Section 29
Presenter: Alexander Bagaev, PhD, BostonGene

Title: 2061 / 19 – Deep immune profiling by mass cytometry revealed an association between the state of immune system before treatment and response to checkpoint inhibitor therapy in clear cell renal cell carcinoma
Session: PO.IM02.13 – Immune Response to Therapies 1
Date and Time: Monday, April 11 | 1:30 PM – 5:00 PM
Location: Exhibit Halls D-H, Poster Section 37
Presenter: Michael Goldberg, PhD, BostonGene

Research conducted with Stanford University School of Medicine and Washington University School of Medicine

E-Poster presentations

E-Posters will be available starting at 1:00 PM CST on Friday, April 8, 2022, the first day of the AACR (Free AACR Whitepaper) Annual Meeting. All e-posters will be made available for browsing on the AACR (Free AACR Whitepaper) Annual Meeting website on this date.

Title: 3823 / 23 – Viral transcript and tumor immune microenvironment-based transcriptomic profiling of HPV-associated head and neck cancer identifies subtypes associated with prognosis
Session: PO.TB06.04 – Gene Expression and the Microenvironment
Presenter: Daria Kiriy, BostonGene

Research conducted with Massachusetts General Hospital, University of Kentucky, Vanderbilt University Medical Center, University of Pittsburgh Cancer Institute, Washington University School of Medicine, Harvard Medical School

Title: 6151 – Tumor microenvironment heterogeneity identifies potential biomarkers of response in ER-positive breast cancers treated with palbociclib
Session: OPO.TB06.01. Tumor Microenvironment
Presenter: Maria Bruttan, BostonGene

Research conducted with Cedars-Sinai Medical Center, Stanford University School of Medicine, and Washington University School of Medicine

Title: 5172 – B cell content in the tumor microenvironment is associated with improved survival in stage II lung adenocarcinoma
Session: OPO.CL11.01 – Biomarkers
Presenter: Ivan Valiev, MSc, BostonGene

Research conducted with Massachusetts General Hospital

Additionally, the abstracts will be published in an online-only Proceedings supplement to the AACR (Free AACR Whitepaper) journal Cancer Research after the completion of the AACR (Free AACR Whitepaper) Annual Meeting.

Gamida Cell to Present Corporate Highlights and Participate in Panel Discussion at the Needham Healthcare Conference

On April 7, 2022 Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapies for patients with solid and hematological cancers and other serious diseases, reported that company management will present at the upcoming 21st Annual Needham Virtual Healthcare Conference on April 12, 2022 at 1:30 p.m. EDT (Press release, Gamida Cell, APR 7, 2022, View Source [SID1234611606]). Management will discuss 2022 catalysts and potential milestones including executing its U.S. commercial strategy for the launch of the first allogenic stem cell therapy upon U.S. Food and Drug Administration approval, accelerating the development of its first-in-class NAM-enabled natural killer (NK) cell therapy, GDA-201, as a new approach for patients with follicular and diffuse large B-cell lymphomas, and expansion of its NAM-enabled cell therapy pipeline with multiple next-generation, genetically engineered NK cells.

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Additionally, Julian Adams, Ph.D., chief executive officer of Gamida Cell, will participate in a live panel discussion titled "Company Perspectives: Companies Discussing Key Features and Differentiators in the NK Cellular Therapeutics Space," on April 14, 2022 at 11:00 a.m. EDT.

The webcast of the presentation will be available on the "Investors & Media" section of Gamida Cell’s website at www.gamida-cell.com, and will be available for at least 14 days following the event.

About NAM Technology

Our NAM-enabling technology is designed to enhance the number and functionality of targeted cells, enabling us to pursue a curative approach that moves beyond what is possible with existing therapies. Leveraging the unique properties of NAM, we are able to expand and metabolically modulate multiple cell types — including stem cells and natural killer cells — with appropriate growth factors to maintain the cells’ active phenotype and enhance potency. This allows us to administer a therapeutic dose of cells that may help cancer patients live longer better lives.

Vizgen Showcases Benefits of Spatial Genomics Platform in Understanding the Tumor Microenvironment at AACR 2022 Annual Meeting

On April 7, 2022 Vizgen, the life science company dedicated to improving human health by visualizing single-cell spatial genomics information, reported that it will be presenting a poster at the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (Press release, Vizgen, APR 7, 2022, View Source [SID1234611605]). Conducted with Massachusetts General Hospital (MGH), the poster will report how a spatially resolved map of colorectal cancer can best identify novel spatial relationships between cancer cells and the microenvironment. An e-poster will be made available beginning on Friday, April 8 at 1 p.m. ET.

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Poster Presentation Details:
Title: A single-cell spatially resolved map of colorectal cancer identifies novel spatial relationships between cancer cells and the microenvironment
Presenting Author: Colles Price, MS, Ph.D., Senior Research Scientist – Oncology Lead, Vizgen
Abstract #: 2030
Session Title: Spatial Proteomics and Transcriptomics
Session Date and Time: April 11, 2022, 1:30 p.m. – 5:00 p.m.
Location: New Orleans Convention Center, Poster Section 34, Poster Board #8

In addition to the company’s poster presentation at AACR (Free AACR Whitepaper), Vizgen showcased preliminary data performing in situ single-cell transcriptomic imaging in formalin-fixed paraffin-embedded (FFPE) tissue sections with its MERSCOPE platform, powered by multiplexed error robust in situ hybridization (MERFISH) technology. FFPE tissues are the most widely used clinical sample types in histology and molecular diagnosis. However, due to RNA degradation and protein crosslinking, FFPE samples are often not compatible with single-cell transcriptomic analysis. Dr. Jiang He, Scientific Co-founder and Senior Director of Scientific Affairs at Vizgen, recently presented a webinar demonstrating MERFISH imaging in more than 15 FFPE sample types from mouse and human, including archival clinical samples. The webinar can be viewed here.

"We are buoyed by the tremendous adoption of MERSCOPE since the platform’s U.S. launch in the beginning of the year as customers realize the vast benefits of a high multiplexing, high resolution in situ platform to combine single-cell and spatial genomics," said Terry Lo, President and CEO of Vizgen. "Spatial context, as underscored by the presentation at AACR (Free AACR Whitepaper), is critical to advancing therapies for immunologically distinct colon cancer types and the high resolution and sensitivity of MERSCOPE data has the potential to aid researchers in uncovering new findings in the tumor microenvironment."

AngioDynamics Reports Fiscal 2022 Third Quarter Financial Results; Reaffirms Fiscal Year 2022 Guidance

On April 7, 2022 AngioDynamics, Inc. (NASDAQ: ANGO), a leading and transformative medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options and improving quality of life for patients, reported financial results for the third quarter of fiscal year 2022, which ended February 28, 2022 (Press release, AngioDynamics, APR 7, 2022, View Source [SID1234611604]).

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"We are proud of our team’s ability to drive continued growth in our business during the third quarter while operating amid macro-related supply chain disruptions, procedural volume challenges and ongoing inflation, particularly in December and January. During the quarter, we made significant progress implementing our manufacturing capacity enhancement initiatives, exiting the quarter with an approximately 20% increase in production hours. Even as we started to see benefits of our capacity enhancement initiatives, we saw our backlog increase during our third quarter, signaling continued strong customer demand. Since mid-February, we have seen steady improvement in procedure volumes and remain confident in both the long-term growth trajectory of our portfolio and the strategic transformation of the Company," commented Jim Clemmer, President and Chief Executive Officer of AngioDynamics.

Clemmer continued, "Despite the increased COVID and macro headwinds in our third quarter, we continued to invest in our transformation to make Med Tech comprise a larger, faster-growing piece of our business. As an example, we are pleased to announce the recent FDA clearance of our AlphaVac F18 thrombectomy system for use in the venous vasculature and approval of our IDE study for the use of AlphaVac F18 to treat pulmonary embolism."

Third Quarter 2022 Financial Results

Net sales for the third quarter of fiscal 2022 were $74.0 million, an increase of 3.9% compared to the prior-year quarter.

Foreign currency translation did not have a significant impact on the Company’s sales in the quarter.

Med Tech net sales were $19.6 million, a 28.6% increase from $15.2 million in the prior- year period, while Med Device net sales were $54.4 million, a decrease of 2.8% compared to $55.9 million in the prior-year period. Med Tech includes the Auryon Peripheral Atherectomy platform, the thrombectomy platform and the NanoKnife irreversible electroporation platform. The Company’s performance was impacted by headwinds related to the Omicron variant spike, particularly during the months of December and January, which included supply chain disruptions, procedural challenges and continued inflationary pressures.

Endovascular Therapies (formerly Vascular Interventions and Therapies) net sales were $38.1 million, an increase of 14.5%, compared to $33.3 million a year ago. Growth was driven by strength in our atherectomy and thrombectomy portfolios relative to the prior-year period. Auryon sales during the quarter were $7.3 million, as the Company continued to see sequential sales growth of this platform.
Oncology net sales were $12.5 million, a decrease of 5.0%, compared to $13.1 million in the prior-year period. The year-over-year decline was largely due to procedural volume pressures related to COVID and lower NanoKnife capital sales, partially offset by increased sales of NanoKnife disposables in the U.S.
Vascular Access net sales were $23.4 million, a decrease of 5.6%, compared to $24.8 million a year ago.
Med Device products make up the majority of the Company’s backlog, which stood at approximately $9.6 million at the end of the third quarter.
U.S. net sales in the third quarter of fiscal 2022 were $62.4 million, an increase of 6.5% from $58.7 million a year ago. International net sales were $11.5 million, a decrease of 8.0%, compared to $12.5 million a year ago. International net sales were primarily impacted by the global Omicron variant spike and reduced capital sales.

Gross margin for the third quarter of fiscal 2022 was 52.2%, a decrease of 190 basis points compared to the third quarter of fiscal 2021. During the quarter, gross margin continued to be negatively impacted by macro forces including the tight labor market and increased expense for raw materials, labor and freight.

The Company recorded a net loss of $5.0 million, or a loss per share of $0.13, in the third quarter of fiscal 2022. This compares to a net loss of $3.5 million, or a loss per share of $0.09, a year ago.

Excluding the items shown in the non-GAAP reconciliation table below, adjusted net income for the third quarter of fiscal 2022 was $1.3 million, and adjusted earnings per share was $0.03 compared to adjusted net income in the prior-year period of $0.7 million and adjusted earnings per share of $0.02. Adjusted net income and adjusted earnings per share in the third quarter of fiscal 2022 includes a $4.2 million, or $0.08 per share benefit, respectively, related to the reimbursement of certain expenses under the employee retention credit as part of the CARES Act. A similar reimbursement benefit of $1.9 million was included in the prior year period.

Adjusted EBITDA in the third quarter of fiscal 2022, excluding the items shown in the reconciliation table below, was $6.7 million, compared to $5.4 million in the third quarter of fiscal 2021.

In the third quarter of fiscal 2022, the Company utilized $8.8 million in operating cash, had capital expenditures of $1.1 million and additions to Auryon placement and evaluation units of $1.5 million. As of February 28, 2022, the Company had $23.9 million in cash and cash equivalents compared to $34.3 million in cash and cash equivalents on November 30, 2021. The Company had debt outstanding of $25.0 million on February 28, 2022, unchanged from November 30, 2021.

Nine Months Financial Results

For the nine months ended February 28, 2022:

Net sales were $229.2 million, an increase of 7.0%, compared to $214.2 million for the same period a year ago.
Med Tech net sales were $56.1 million, a 41.8% increase from the prior year period. Med Device net sales were $173.1 million, a decrease of 0.8% from the prior year period.
The Company’s net loss was $20.3 million, or a loss of $0.52 per share, compared to a net loss of $12.1 million, or a loss of $0.32 per share, a year ago.
Gross margin decreased 140 basis points to 52.0% from 53.4% a year ago.
Excluding the items shown in the non-GAAP reconciliation table, below, adjusted net loss was $0.4 million, with adjusted loss per share of $0.01, compared to adjusted net income and adjusted earnings per share of $1.9 million, and $0.05, respectively, a year ago.
Adjusted EBITDA, excluding the items shown in the reconciliation table below, was $14.7 million, compared to $15.0 million for the same period a year ago.
Reiterating Fiscal Year 2022 Guidance

The Company continues to expect:

Fiscal year 2022 net sales to be in the range of $310 to $315 million;
Gross margin to be in the range of 52.0% to 54.0%; and
Adjusted earnings per share in the range of a loss of $0.02 to a gain of $0.02.
Conference Call

The Company’s management will host a conference call today at 8:00 a.m. ET to discuss its third 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 13727875.

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, April 7, 2022, until 11:59 p.m. ET on Thursday, April 14, 2022. To hear this recording, dial 1-844-512-2921 (domestic) or +1-412-317-6671 (international) and enter the passcode 13727875.

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 and adjusted earnings per share. 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.

Fortress Biotech to Present at the 21st Annual Needham Virtual Healthcare Conference

On April 7, 2022 Fortress Biotech, Inc. (NASDAQ: FBIO) ("Fortress"), an innovative biopharmaceutical company focused on efficiently acquiring, developing and commercializing or monetizing promising therapeutic products and product candidates, reported that Lindsay A. Rosenwald, M.D., Chairman, President and Chief Executive Officer, will present a corporate update at the 21st Annual Needham Virtual Healthcare Conference on Tuesday, April 12, 2022, at 1:30 p.m. ET and will participate in one-on-one meetings during the conference (Press release, Fortress Biotech, APR 7, 2022, View Source [SID1234611603]).

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A live webcast of the presentation will be available on the News / Events page, located within the Investors section of Fortress’ website, View Source, for approximately 30 days.