On April 22, 2021 EDAP TMS S.A. (NASDAQ: EDAP) (the "Company"), a global leader in robotic energy-based therapies, reported the launch of a follow-on public offering of its American Depositary Shares, or ADSs, each representing one ordinary share of the Company (Press release, EDAP TMS, APR 22, 2021, View Source,ordinary%20share%20of%20the%20Company. [SID1234578410]).

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Piper Sandler is acting as the sole book-running manager for the offering.

A shelf registration statement on Form F-3 (including a prospectus) relating to the Company’s American Depositary Shares was filed with the Securities and Exchange Commission (the "SEC") and has become effective. The Company has also filed a preliminary prospectus supplement with respect to the proposed offering. Before purchasing ADSs in the offering, you should read the preliminary prospectus supplement and the accompanying prospectus, together with the documents incorporated by reference therein. You may obtain these documents for free by visiting EDGAR on the SEC’s website at www.sec.gov. Alternatively, a copy of the preliminary prospectus supplement (and accompanying prospectus) relating to the offering may be obtained from Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, Attention: Prospectus Department, by telephone at (800) 747-3924 or by email at [email protected].

The Company also announced that it expects to report that total revenues were between €10.0 million and €10.4 million for the three months ended March 31, 2021, primarily driven by strength in its Distribution division, as compared to €7.6 million for the same period in 2020, with the Company’s gross margin expected to be between 40% and 44% for the period, as compared to 40.2% gross margin for the same period in 2020. The Company also expects to report that its cash and cash equivalents were approximately €24.4 million as of March 31, 2021.

In this press release, the Company has presented preliminary estimates of certain unaudited financial information for the three months ended March 31, 2021. The Company has provided ranges, rather than specific amounts, for the preliminary estimates of the unaudited financial information primarily because its financial closing procedures for the three months ended March 31, 2021 are not yet complete and, as a result, its final results upon completion of its closing procedures may vary materially from the preliminary estimates. The preliminary results are not a comprehensive statement of the Company’s financial results for this period. In addition, even if the Company’s actual results are consistent with these preliminary results, those results or developments may not be indicative of results or developments in subsequent periods. The preliminary estimates for the three months ended March 31, 2021 presented in this press release have been prepared by, and are the responsibility of, management. KPMG S.A., the Company’s independent registered public accounting firm, has not audited, reviewed, compiled or performed any procedures with respect to such preliminary data. Accordingly, KPMG S.A. does not express an opinion or any other form of assurance with respect thereto, and you should not place undue reliance upon these preliminary estimates.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. In particular, no public offering of the ADSs will be made in Europe.

On April 22, 2021 Clinical Outcomes Solutions (‘COS’), a global leader in the collection, analysis and reporting of patient-centered outcomes data with offices in Tucson and Chicago (USA) and Folkestone (UK), reported a collaborative partnership with Carevive Systems (‘Carevive’), the leading oncology-focused health technology company (Press release, Carevive Systems, APR 22, 2021, View Source [SID1234578408]).

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The two organizations, both deeply experienced with the collection and analysis of oncology data, are proud to announce that Carevive is joining the Oncology Outcomes initiative, launched in February 2019, to deliver world-class data and analysis to improve the patient experience and enhance survival outcomes of cancer patients.

The partnership will leverage Carevive’s innovative digital oncology platform to capture the patient experience while on treatment, and COS’ deep experience in analyzing these types of data, providing invaluable insights for life science companies and regulatory authorities.

The Carevive platform PROmpt enables cancer care teams to monitor and manage their patients remotely, which improves survival outcomes and patient quality of life. The platform also enables large-scale digital data collection via the Oncology Pragmatic Trial Investigator Network (Carevive OPT-IN), merging electronic medical records (EMR) with patient reported outcomes (PRO) to offer cancer centers a holistic, longitudinal view of their patient population for quality improvement and pathway enhancement purposes.

COS is a global leader in delivering innovative science to capture and communicate the patient voice, in order to provide actionable evidence through qualitative and quantitative research, with a specific focus on Clinical Outcomes Assessments in the oncology space. Through the partnership, COS will apply this expertise to providing data analytic support to generate insights from these novel patient experience datasets.

Stacie Hudgens, Chief Executive Officer at COS, said: "We are very excited to announce this partnership with Carevive, an organization that shares our deep-rooted passion for world-class oncology research to improve the patient experience.

"The depth and breadth of the Carevive datasets provide access to a host of data on solid tumors and liquid cancers, and will enhance our ability to improve the patient journey."

Bruno Lempernesse, Chief Executive Officer at Carevive, said: "Carevive is committed to reshaping the way cancer care is delivered so that therapies can become more personalized through the use of real-world patient data. We are delighted to announce this partnership with COS, an organization that has supported the development of our patient experience data collection efforts from its inception. By combining COS’ FDA and industry expertise with Carevive data, this partnership provides a model of how to approach real-world evidence and patient-reported outcomes with cancer care teams, regulatory authorities and life science companies."

Tara Symonds, Chief Science Officer at COS, added: "We have seen the benefit from monitoring patient symptoms over time while on treatment across numerous cancer types. Oncology treatments are highly toxic and can cause significant side effects. Thus, effective, real-time monitoring enables far quicker intervention and the opportunity to improve the patient experience and enhance symptom management.

"Research conducted by renowned medical oncologist and PRO expert Ethan Basch M.D., has shown that such intervention can add six months to survival, a significant finding for the benefit of patients with cancer. Digital Health Solutions, such as the Carevive platform, are the key to demonstrating the extent to which patients’ symptoms and quality of life are improved by particular treatments, and are rapidly becoming a critical tool for our clients when conducting real-world assessments of the impact of their drugs.

"The platform also offers additional benefits, such as the opportunity to design real-world studies for our clients, which would not be possible without access to Carevive’s database."

On April 22, 2021 MonTa Biosciences, a Danish clinical stage biotech company located in Copenhagen, reported the first patient has been dosed with Monta Bioscienes MBS8 in a Phase I clinical trial (Press release, MonTa Biosciences, APR 22, 2021, View Source [SID1234578399]). Patients with solid tumors are enrolled at two danish hospitals in Copenhagen, Rigshospitalet and Herlev Hospital. 30-50 patients will be enrolled over the next 18 months.

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MonTa Biosciences lead candidate MBS8 was administered intravenously to the first patient in the trial at Rigshospitalet in Copenhagen on Wednesday, April 21. The primary objective of the trial is to evaluate the safety of multiple escalating doses of MBS8 for patients with advanced solid tumours and to establish the maximum tolerated dose (MTD/recommended Phase 2 dose (RP2D). The effects on biomarkers and objective tumor response in the patients will also be assessed.

MBS8 treatment is an innovative way to stimulate the immune system to help the body fight cancer. MBS8 is a nanoparticle that contains an immune stimulating compound called a TLR7 agonist that activate certain types of immune cells which are able to enter tumor tissue from the blood and kill tumor cells. After weeks of treatment MBS8 is also able to stimulate immune memory T-cells to recognize and eliminate cancer cells, which is of particular interest to cancer patients with metastatic disease, where there is a huge unmet medical need for better treatment.

MonTa Biosciences’ CEO, Simon S Jensen said "We are very excited to have the first patient dosed with MBS8 and hope the drug will demonstrate to be safe for the patients, and even more important also have an impact on their cancer. With the new mode of action for MBS8, which has never been seen for any cancer drug before, we have high expectations to MBS8 and hope we already in this phase I will be able to help patients in need. It is quite rare to see drugs acting as monotherapy on the immune system as efficiently as MBS8, often cancer immunotherapy treatments are combined with other treatments to enhance their therapeutic activity."

On April 22, 2021 NRG Oncology reported that The first National Institutes of Health (NIH) National Cancer Institute (NCI)-funded clinical study examining stereotactic body radiotherapy (SBRT) in the treatment of oligometastatic breast, prostate, and non-small cell lung (NSCLC) cancers displayed evidence that SBRT can be safely used to treat patients who have multiple metastases (Press release, NRG Oncology, APR 22, 2021, View Source [SID1234578397]). These results were recently published in JAMA Oncology.

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The results of the Phase I NRG-BR001 trial, conducted by the NCI National Clinical Trials Network group NRG Oncology, indicate that SBRT treatment in standard doses was safe for 35 evaluable patients with a median of 3 metastases. There were no dose-limiting toxicities and over 50% of trial participants were alive at 2 years following treatment.

"Prior to this trial, little to no evidence was available to support that SBRT is a safe and tolerable treatment option for patients who have multiple metastases. Researchers have hypothesized that SBRT could improve survival outcomes for this patient population; however, it was imperative we determine the safety of this procedure, appropriate dose and scheduling, and how to coordinate across multiple centers the quality assurance of the procedures prior to testing its efficacy," stated Steven J. Chmura, MD, PhD, of the Department of Radiation and Cellular Oncology at the University of Chicago Comprehensive Cancer Center and the lead author of the NRG-BR001 manuscript. "To ensure safety, this trial used an extensive radiation QA process to test the accuracy of treating moving tumors and was the first NRG trial to require the use of 3D image guidance during treatment for soft tissue tumors."

NRG-BR001 enrolled up to 6 evaluable patients for each of the following 7 selected anatomic locations: bone/osseous (BO), spinal/paraspinal (SP), peripheral lung (PL), central lung (CL), abdominal/pelvic (AP), mediastinal/cervical lymph node (MC), and liver (L).As a single patient could contribute to more than one location, the safety question was able to be answered with 35 evaluable patients from the 42 enrolled trial participants. Patients were required to have 3-4 metastases or 2 metastases in close proximity to each other. SBRT starting dose was 50 GY over 5 fractions for the CL and MC groups, 45 GY over 3 fractions for the PL, AP, and L groups and 30 Gy over 3 fractions for the BO and SP group. Additional patients would be accrued as needed at defined de-escalated doses if any of the starting doses were not deemed to be safe.

The 35 evaluable patients had breast (n=12), NSCLC (n=10), and prostate (n=13) cancers. No dose de-escalations were needed. There were 8 instances of grade 3 adverse events. There were no treatment-related deaths.

SBRT for multiple metastases is now utilized in multiple ongoing Phase II and III NCI-sponsored trials. Follow-up research should be done in long surviving oligometastatic patients.

"These are important data from the multicenter study, confirming that complicated stereotactic body radiotherapy to multiple sites is safe and feasible. We eagerly await the results of ongoing, larger randomized trials to demonstrate how effective this is when compared to drug therapy alone for metastatic cancer," stated Mitchell Machtay, MD, the Associate Dean for Clinical Cancer Research at the Penn State College of Medicine and the interim Group Chair for NRG Oncology.

NRG Oncology BR001 was supported by grants UG1CA189867 (NRG Oncology NCORP), U10CA180868 (NRG Oncology Operations), U10CA180822 (NRG Oncology SDMC), U24CA180803 (IROC) from the National Cancer Institute (NCI).

Citation
Chmura S, Winter KA, Robinson C, Pisansky TM, Borges V, Al-Hallaq H, Matuszak M, Park SS, Yi S, Hasan Y, Bazan J, Wong P, Yoon HA, Horton J, Gan G, Milano M, Sigurdson ER, Moughan J, Salama JK, White J. The Safety of Stereotactic Body Radiotherapy (SBRT) for the Treatment of Multiple Metastases: Findings from the NRG Oncology NRG-BR001. JAMA Oncol. doi:10.1001/jamaoncol.2021.0687. [Epub ahead of print].

On April 22, 2021 Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, reported that it will release its first quarter 2021 financial results on Thursday, May 6, 2021 (Press release, Insmed, APR 22, 2021, View Source [SID1234578386]).

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Insmed management will host a conference call for investors beginning at 8:30 a.m. ET on Thursday, May 6, 2021 to discuss the financial results and provide a business update.

Shareholders and other interested parties may participate in the conference call by dialing (833) 340-0284 (domestic) or (236) 712-2425 (international) and referencing conference ID number 2257423. The call will also be webcast live on the company’s website at www.insmed.com.

A replay of the conference call will be accessible approximately two hours after its completion through June 5, 2021 by dialing (800) 585-8367 (domestic) or (416) 621-4642 (international) and referencing conference ID number 2257423. A webcast of the call will also be archived for 90 days under the Investor Relations section of the company’s website at www.insmed.com.