On May 17, 2022 EDAP TMS SA (Nasdaq: EDAP) (the "Company"), a global leader in robotic energy-based therapies, reported unaudited financial results for the first quarter 2022 (Press release, EDAP TMS, MAY 17, 2022, View Source [SID1234614814]).

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Marc Oczachowski, EDAP’s Chairman and Chief Executive Officer, said: "As we announced in our business update press release just a few weeks ago, the first quarter was one in which the positive impact of our new U.S. organization, led by CEO Ryan Rhodes, was featured prominently. We ended 2021 on a strong note and continued that momentum into Q1 by adding three more highly regarded U.S. academic medical centers to our client roster, including New York-Presbyterian/Weill Cornell Medical Center, Beth Israel Deaconess Lahey Health, an affiliate of Harvard Medical School, and University of California Davis Medical Center in Sacramento. We also sold a Focal One outside of the U.S.

"Combined with another strong quarter from our distribution business, we grew revenue 26% year-over-year in the first quarter. We have a very rich pipeline of US prospects – both academic medical centers and community hospitals – and I am confident that we will continue to convert these to Focal One reference sites this year as acceptance of focal therapy as a treatment option within the urology suite continues to gain acceptance."

Ryan Rhodes, Chief Executive Officer of EDAP US, stated, "2022 represents the first year in which we entered the year with a right-sized U.S. organization capable of capturing the significant untapped opportunity at a time when more and more urologists are recognizing the value of HIFU along the prostate cancer care continuum. The interest in our technology that we saw at last week’s American Urology Association meeting confirms that we are in the right place at the right time, with a cutting-edge platform that can truly make a positive difference in the lives of prostate cancer patients. I believe we are set up for a successful year even while we continue to make measured investments in our U.S. infrastructure."

First Quarter 2022 Results

Total revenue for the first quarter 2022 was EUR 13.0 million (USD 14.5 million), an increase of 26% as compared to total revenue of EUR 10.3 million (USD 12.4 million) for the same period in 2021.

Total revenue in the HIFU business for the first quarter 2022 was EUR 3.8 million (USD 4.3 million), as compared to EUR 1.8 million (USD 2.2 million) for the first quarter of 2021. The increase was driven by four Focal One units sold in the first quarter 2022 versus zero units sold in the first quarter 2021.

Total revenue in the LITHO business for the first quarter 2022 was EUR 2.2 million (USD 2.5 million), as compared to EUR 2.9 million (USD 3.5 million) for the first quarter of 2021. The decline was driven by one lithotripsy unit sold in the first quarter of 2022 as compared to six units sold in the first quarter of 2021.

Total revenue in the Distribution business for the first quarter 2022 was EUR 7.0 million (USD 7.8 million), as compared to EUR 5.6 million (USD 6.7 million) for the first quarter of 2021. The increase was driven primarily by nine ExactVu units sold during the first quarter of 2022 as compared to five units sold during the first quarter of 2021.

Gross profit for the first quarter 2022 was EUR 5.8 million (USD 6.4 million), compared to EUR 4.4 million (USD 5.2 million) for the year-ago period. Gross profit margin on net sales was 44.3 % in the first quarter of 2022, compared to 42.4% in the year-ago period.

Operating expenses were EUR 5.9 million (USD 6.6 million) for the first quarter of 2022, compared to EUR 4.1 million (USD 5.0 million) for the same period in 2021.

Operating loss for the first quarter of 2022 was EUR 0.1 million (USD 0.1 million), compared to an operating profit of EUR 0.2 million (USD 0.3 million) in the first quarter of 2021.

Net income for the first quarter of 2022 was EUR 0.4 million (USD 0.4 million), or EUR 0.01 per diluted share, as compared to net income of EUR 0.8 million (USD 0.9 million), or EUR 0.03 per diluted share in the year-ago period.

As of March 31, 2022, the company held cash and cash equivalents of EUR 46.5 million (USD 51.6 million) as compared to EUR 47.2 million (USD 53.4 million) as of December 31, 2021.

Conference Call

An accompanying conference call and webcast will be conducted by management to review the results. The call will be held at 8:30am EDT tomorrow, May 18, 2022. Please refer to the information below for conference call dial-in information and webcast registration.

Following the live call, a replay will be available on the Company’s website, www.edap-tms.com under "Investors Information."

On May 17, 2022 Diffusion Pharmaceuticals Inc.(NASDAQ: DFFN) ("Diffusion" or the "Company"), a biopharmaceutical company developing novel therapies that enhance the body’s ability to deliver oxygen to areas where it is needed most, reported that Robert Cobuzzi, Jr., Ph.D., the Company’s President and Chief Executive Officer, will be presenting at the H.C. Wainwright Global Investment Conference being held at the Fontainebleau Miami Beach Hotel from May 23-26, 2022 (Press release, Diffusion Pharmaceuticals, MAY 17, 2022, https://www.diffusionpharma.com/press-release/diffusion-pharmaceuticals-to-present-at-h-c-wainwright-global-investment-conference/ [SID1234615256]).

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The presentation will be virtual and will provide an overview of recent business and corporate achievements at Diffusion, including an update on TSC clinical trials.

Details of the presentation are as follows:

Date & Time: On demand, beginning 7.00 a.m. ET, Tuesday, May 24, 2022

A replay of the presentation will be available under the presentations section of the Company website at www.diffusionpharma.com. In addition, Dr. Cobuzzi will be available for one-on-one meetings during the conference. Registered investors will be able to request a meeting with management via the conference portal.

On May 17, 2022 QIAGEN reported the launch of the therascreen EGFR Plus RGQ PCR Kit, a new in-vitro diagnostic test for sensitive EGFR mutation analysis, detecting all currently known activating and resistance EGFR mutations (Press release, Qiagen, MAY 17, 2022, View Source [SID1234614716]). The real-time qPCR test builds on the established therascreen EGFR RGQ PCR Kit and provides improved limits of detection, quicker turnaround times, automated sample extraction options and automated results analysis.

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In addition to the T790M mutation, the new kit now also detects C797S. This key biomarker indicates resistance to third-generation EGFR tyrosine kinase inhibitor [TKI], giving oncologists additional insights to adjust EGFR treatment for NSCLC patients. The kit also delivers next-day results and automated analysis, making it an ideal choice for labs that require a high-performing test solution for either tissue or plasma with a rapid turnaround.

"The therascreen EGFR Plus RGQ PCR Kit combines sensitivity in mutation detection with the flexibility to test both tissue and liquid samples, helping oncologists to make confident, informed treatment decisions for patients with advanced NSCLC", said Kai te Kaat, Vice President, Head of Global R&D Molecular Diagnostics at QIAGEN. "With this launch, we continue to further advance our Precision Medicine portfolio by covering new clinically relevant mutations such as C797S that further improve patient outcomes."

Genomic testing is instrumental for patient management in non-small cell lung cancer, and testing for driver mutations in EGFR aids oncologists to make informed treatment decisions for patients. The therascreen EGFR Plus RGQ PCR Kit is a more cost-effective and simpler alternative to NGS for routine follow-up testing once an EGFR mutation is known. The kit can test FFPE and plasma samples within the same run, allowing for matched testing of FFPE and plasma and removing the need for laboratories to batch samples of either type before a run. The decreased invasiveness of plasma sampling allows clinicians to schedule routine testing of patients on treatment to track treatment effectiveness and establish whether resistance is occurring.

Extraction can be performed manually or automated on the QIAsymphony SP for walkaway sample processing. Sensitive real-time PCR is then performed on the Rotor-Gene Q MDx 5plex HRM instrument with automated data analysis using Rotor-Gene AssayManager software. The software displays qualitative results informing the operator if one or more of the 42 EGFR mutations are present. The Sample to Insight workflow can be completed in under 8 hours, providing next-day results and informing earlier treatment decisions.

QIAGEN is a pioneer in Precision Medicine, particularly through its therascreen assay portfolio that allow the detection of clinically relevant genetic alterations to provide insights that guide clinical decision-making in diseases such as cancer.

To learn more about EGFR mutation testing in NSCLC, visit www.qiagen.com/EGFR-Plus.

On May 17, 2022 Enveric Biosciences, Inc. (NASDAQ: ENVB) ("Enveric" or the "Company"), a neuroscience-focused biotechnology company developing next-generation, psychedelic-inspired mental health medicines, reported that Dr. Joseph Tucker, Chief Executive Officer of Enveric, will participate virtually in the H.C. Wainwright Global Investment Conference to be held on May 23-26, 2022 (Press release, Enveric Biosciences, MAY 17, 2022, https://www.enveric.com/news/enveric-biosciences-to-participate-in-the-h-c-wainwright-global-investment-conference-on-may-23-26-2022/ [SID1234614749]).

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Dr. Tucker’s corporate presentation will be available on-demand starting Tuesday, May 24th at 7:00 a.m. ET. Register to attend here.

For more information about the conference, or to schedule a one-on-one meeting with Enveric’s management team, please contact your appropriate H.C. Wainwright representative, or send an email to KCSA Strategic Communications at [email protected].

On May 17, 2022 Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) a clinical stage biopharmaceutical company dedicated to meeting unmet medical needs in oncology, autoimmune diseases and infectious diseases, reported that Mr. Darren Lui, President and Executive Director of Aptorum Group will present virtually at the H.C. Wainwright Global Investment Conference being held on May 23-26, 2022 (Press release, Aptorum, MAY 17, 2022, View Source [SID1234614767]).

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Aptorum Group management will be available and conducting online one-on-one meetings with institutional investors through the conference. To register for the conference, please visit: View Source