New Guidelines from AUA and ASTRO Support Inclusion of Genomic Testing in Localized Prostate Cancer

On May 17, 2022 Myriad Genetics reported that According to the American Cancer Society, in 2022 more than 268,000 men in the United States will be diagnosed with prostate cancer, making it the second most common cancer in men (Press release, Myriad Genetics, MAY 17, 2022, View Source [SID1234614908]). Tragically, close to 35,000 men will die from prostate cancer in 2022. About 1 in 8 men will be diagnosed with prostate cancer during his lifetime.

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Last week, we attended the 2022 American Urological Association (AUA) National Meeting. It was an informative three days spent exploring the latest advancements in urology and showcasing the power of genetic insights to personalize prostate cancer treatment.

While at the meeting, AUA and American Society for Radiation Oncologists (ASTRO) shared updated guidelines that support including genomic testing in localized prostate cancer.

For the first time, prognostic biomarker tests, such as Myriad Genetics’ Prolaris Prostate Cancer Test, are specifically cited in the guidelines as a potential tool that can be used to incorporate personalized genomic insights into prostate cancer care and clinical treatment decision-making. Additionally, the guidelines recommend physicians perform a risk assessment to help guide the decision to offer germline testing, including an analysis of mutations associated with aggressive prostate cancer or are known to have implications for treatment.  

The inclusion of tumor prognostic and germline testing represents another step forward to offer a clearer and more personalized treatment path for men with prostate cancer.

Genetic insights for more actionable and personalized prostate cancer treatment

Myriad Genetics is the only lab offering the combination of both prognostic tumor analysis and germline testing for individuals affected by prostate cancer.

 Prolaris is a prognostic, tumor-based mRNA expression test that measures the aggressiveness of a man’s prostate cancer. It combines a genomic tumor aggressiveness score with traditional, diagnostic features like Prostate-Specific Antigen (PSA), Gleason, and tumor stage, helping physicians identify which patients are safe for active surveillance, would benefit from a single mode of therapy, or require greater intensity of treatment.  Prolaris has already been broadly recommended by the National Comprehensive Cancer Network (NCCN) for use in low, intermediate and high-risk disease.

Myriad offers germline testing with its MyRisk Hereditary Cancer Test, as well as its FDA-approved companion diagnostic test, BRACAnalysis CDx, which helps identify patients that are most likely to benefit from PARP-inhibitor therapy based on germline BRCA1/BRCA2 status.

More than three million patients have been tested to date with our MyRisk, Prolaris, and companion diagnostic tests.  Prognostic tests, like Prolaris, and germline companion diagnostic tests, like BRACAnalysis CDx, can help better determine the behavior of a patient’s tumor, providing actionable data-driven information physicians need to create an individualized treatment plan.

For more information on how Myriad Genetics continues to innovate and improve the health and well-being for men with prostate cancer. Click here: View Source

Kelun Out-Licenses Global Rights for Candidate to Merck/MSD in $1.4 Billion Deal

On MAY 17, 2022 Sichuan Kelun Pharmaceutical reported that out-licensed global rights (ex-China) for a large molecule candidate to Merck in a deal worth nearly $1.4 billion (Press release, Kelun, MAY 17, 2022, View Source [SID1234614905]). Kelun will receive $47 million in upfront payments and up to $1.36 billion in milestones. Although the candidate was not identified, it is expected to be SKB264, a third-gen TROP2-targeting antibody-drug conjugate in Phase II trials in the US and China. The candidate is being developed by KLUS Pharma, Kelun’s New Jersey-based novel drug developing subsidiary. Merck is known as MSD outside of North America.

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EDAP Reports First Quarter 2022 Results

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."

XOMA to Present at H.C. Wainwright Global Investment Conference

On May 17, 2022 XOMA Corporation (Nasdaq: XOMA), a biotechnology royalty aggregator playing a distinctive role in helping companies achieve their goal of improving human health, reported its Chairman and Chief Executive Officer, Jim Neal, will present at the H.C. Wainwright Global Investment Conference on Wednesday, May 25, 2022, at 10:00 AM ET (Press release, Xoma, MAY 17, 2022, View Source [SID1234614813]).

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The presentation can be accessed at https://bit.ly/39muQQG or by visiting the investor relations section of the Company’s website at www.xoma.com. A replay of the presentation will be available and archived on the site for 90 days after the event.

Molecular Templates to Present at Upcoming Investor Conferences

On May 17, 2022 Molecular Templates, Inc. (Nasdaq: MTEM, "Molecular Templates," or "MTEM"), a clinical-stage biopharmaceutical company focused on the discovery and development of proprietary targeted biologic therapeutics, engineered toxin bodies (ETBs), reported that it will participate in the following upcoming investor conferences (Press release, Molecular Templates, MAY 17, 2022, View Source [SID1234614812]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Details can be found below:

H.C. Wainwright Global Investment Conference (May 23-26, 2022)
Location: Virtual
Format:

Date: Company Presentation

Tuesday, May 24th
Time: 7:00 AM ET

Jefferies Healthcare Conference (June 8-10, 2022)
Location: Marriott Marquis in New York, New York
Format:

Date: Fireside Chat

Thursday, June 9th
Time: 2:00 PM – 2:25 PM ET
Webcast links for the presentations will be posted on the "News & Media" section of the Molecular Templates corporate website, under Events.