On May 4, 2021 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported it will host a conference call and webcast on Tuesday, May 11 2021 at 5:00 p.m. (EDT) to discuss financial results and corporate developments for the first quarter ended March 31, 2021 (Press release, Navidea Biopharmaceuticals, MAY 4, 2021, View Source [SID1234579107]).

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Jed Latkin, Chief Executive Officer, Dr. Michael Rosol, Chief Medical Officer, and Joel Kaufman, Chief Business Officer, will host the call and webcast to discuss the financial results and provide an update on recent developments and clinical progress. Management will be available to answer questions live immediately following the earnings announcement and prepared remarks portion of the call.

To participate in the call and webcast, please refer to the information below:

A live audio webcast of the conference call will also be available on the investor relations page of Navidea’s corporate website at www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea’s website.

On May 4, 2021 EDAP TMS SA (Nasdaq: EDAP), a global leader in robotic energy-based therapies, reported that it will release its financial results for the first quarter ended March 31, 2021 after the markets close on Tuesday, May 11, 2021 (Press release, EDAP TMS, MAY 4, 2021, View Source,EDAP%20TMS%20S.A.&text=LYON%2C%20France%2C%20May%204%2C,Tuesday%2C%20May%2011%2C%202021. [SID1234579123]).

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An accompanying conference call and webcast will be conducted by Marc Oczachowski, Chairman of the Board and Chief Executive Officer, and François Dietsch, Chief Financial Officer. The call will be held at 8:30am EDT on Wednesday, May 12, 2021. Please refer to the information below for conference call dial-in information and webcast registration.

On May 3, 2021 Labcorp (NYSE: LH), a leading global life sciences company, reported that it has entered into a definitive agreement to acquire select operating assets and intellectual property (IP) from Myriad Genetics’ autoimmune business unit, including the Vectra rheumatoid arthritis (RA) assay (Press release, LabCorp, MAY 3, 2021, View Source [SID1234578976]). More than one million Vectra tests have been completed since the product’s launch in November 2010, and a meaningful portion of testing volume currently flows through Labcorp.

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"Labcorp has consistently been a major player in rheumatology and continues to focus on providing medical professionals with the data they need to best treat their RA patients," said Brian Caveney, M.D., chief medical officer and president of Labcorp Diagnostics. "The addition of the Vectra testing capabilities to our in-house products offers tremendous potential for us to expand the test’s availability and make Labcorp a single-source diagnostics solution for RA providers. We look forward to welcoming the team to Labcorp."

Vectra is a non-invasive, blood-based test that analyzes 12 biomarkers to measure RA disease activity. It combines those measures to generate an easy-to-understand score, which indicates the severity of RA inflammation and how well current treatments are working. It also can predict potential, future joint damage. This enables the 5,000 practicing rheumatologists in the U.S. to provide targeted treatment and adjust existing treatments to better manage RA symptoms.

Rheumatoid arthritis, an autoimmune disorder and one of the most common forms of arthritis, causes painful inflammation and tissue damage in the knees, wrists, and other joints. The U.S. Centers for Disease Control and Prevention project that, by 2040, roughly 26% of the country’s adult population will be living with doctor-diagnosed arthritis such as RA.

The acquisition of the Vectra test and related IP and other assets complements Labcorp’s prior business activity aimed at bolstering its scientific leadership in RA testing and treatment.

The transaction is expected to close by the end of the third quarter, subject to customary closing conditions and regulatory approvals, including under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended. Specific terms of the transaction were not disclosed. Hogan Lovells acted as legal advisor to Labcorp.

On May 3, 2021 DBV Technologies S.A. (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, reported financial results for the first quarter of 2021 (Press release, DBV Technologies, MAY 3, 2021, View Source [SID1234579005]). The quarterly financial statements were approved by the Board of Directors on April 30, 2021.

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"I am pleased with DBV’s overall continued cost reduction measures through the first quarter of 2021," said Daniel Tasse, Chief Executive Officer, DBV Technologies. "We remain diligent about our spend and confident that our cash on hand as of March 31, 2021 will support our operations until the second half of 2022. We continue to focus our attention on advancing Viaskin Peanut’s regulatory dossier and developing our pipeline with the goal of improving the lives of patients with food allergies."

Q1 Financial Highlights1

Cash & Cash Equivalents: cash and cash equivalents as of March 31, 2021 were $152.5 million, compared to $196.4 million as of December 31, 2020. For the three months ended March 31, 2021, the net decrease of $43.9 million was primarily due to cash used in operating activities of $36.2 million and the effect of exchange rates on cash and cash equivalents of $7.9 million. Cash flows used in investment activities were $0.2 million and cash flows from financing activities were $0.4 million. Excluding restructuring amounts paid for $4.9 million on the first quarter of 2021, the cash used in operating activities amounts to $(31.3) million, reflecting the Company’s continued implementation of budget discipline measures. Based on its current assumptions, DBV expects that its current cash and cash equivalents will support its operations until the second half of 2022.

Operating Income: operating income was $2.9 million for the three months ended March 31, 2021, compared to $4.7 million for the three months ended March 31, 2020, a decrease of 37.7%. For both the three months ended March 31, 2021 and 2020, operating income was primarily generated from DBV’s Research Tax Credit (French Crédit Impôt Recherche, or CIR) and from revenue recognized by DBV under its collaboration agreement with Nestlé Health Science. The decrease in operating income is primarily attributable to a decrease of the CIR, as eligible expenses have declined in correlation with Research and Development costs.

Operating Expenses: Operating expenses for the three months ending March 31, 2021, were $32.6 million compared to $45.9 million for the three months ending March 31, 2020. The $13.4 million decrease in operating expenses is mainly attributable to the decrease in personnel expenses, which is directly related to the workforce reduction DBV implemented as part of its 2020 global restructuring plan. The personnel expenses decreased by $9.7 million, from $18.7 million for the three months ended March 31, 2020 to $9.0 million for the three months ended March 31, 2021, a 52% decrease, compared to a 61% decrease of the average number of headcounts between the two periods (311 and 121 FTEs for the three months ended March 31, 2020 and 2021 respectively). As of March 31, 2021, DBV had 104 employees. The decrease in other operating expenses was primarily due to the budget discipline measures taken by DBV. As a result of the ongoing COVID-19 pandemic, DBV also experienced a decrease in other expenses, in particular tradeshows and travel expenses.

Net Loss: Net loss was $(29.4) million for the three months ended March 31, 2021, compared to $(40.9) million for the three months ended March 31, 2020. Net loss per share (based on the weighted average number of shares outstanding over the period) was $(0.54) and $(0.79) for the three months ended March 31, 2021 and 2020, respectively.

The Company will not host a conference call to discuss its first quarter 2021 financial results. It intends to host a conference call to discuss its half-year 2021 financial results in August.

On May 3, 2021 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading clinical-stage precision oncology company enabled by its proprietary synthetic lethality (SL) approach to the discovery and development of novel therapeutics, reported the first patient has been dosed in the Company’s Phase 1 clinical trial of RP-6306, a first-in-class small molecule product candidate targeting PKMYT1, which is a novel target that Repare discovered to be synthetic lethal with CCNE1 amplification and other genomic mutations to treat CCNE1-amplified, FBXW7-altered and other PKMYT1 inhibitor-sensitive cancers (Press release, Repare Therapeutics, MAY 3, 2021, View Source [SID1234579022]).

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"The dosing of the first patient in this RP-6306 trial marks a key milestone in Repare’s development of targeted cancer therapeutics. We are pleased to have initiated this trial six months ahead of what we projected at our IPO launch last June," said Lloyd M. Segal, President and Chief Executive Officer of Repare. "Patients with tumors carrying CCNE1, FBXW7 and certain other genetic alterations we have identified as sensitive to PKMYT1 inhibition have few treatment options available, and the incidence of these cancers is rising. This Phase 1 trial will assess the safety and tolerability of RP-6306, as well as dosing schedule, to inform Repare’s planned Phase 2 program."

The Phase 1 multi-center clinical trial is expected to enroll approximately 70 patients with recurrent tumors characterized by specific genomic alterations predicted by Repare’s SNIPRx platform to render sensitivity to RP-6306. The primary goal of the Phase 1 clinical trial is to assess preliminary safety and tolerability in patients and to establish the recommended Phase 2 dose and dosing schedule for RP-6306 for evaluation in further trials. Subject to completion and review of the Phase 1 clinical trial, the Company expects to advance RP-6306, both as monotherapy and in combination with chemotherapies and other treatment modalities, into proof-of-concept studies in 2022, targeting a variety of patient populations, including those with tumors with CCNE1 amplification, FBXW7 loss or other alterations identified through Repare’s proprietary STEP2 screens.

About RP-6306

RP-6306 is a first-in-class, selective, orally available inhibitor of PKMYT1 that was discovered and developed entirely in-house by Repare. Through Repare’s SNIPRx screen campaign for targets that are SL with CCNE1 amplification, the Company identified and validated this novel SL gene that has the characteristics of a therapeutic target. Repare has developed novel and selective inhibitors against PKMYT1, which demonstrated compelling pre-clinical anti-tumor activity alone and in combination with certain anticancer agents, and subsequently announced the advancement of a clinical candidate to this potential, first-in-class program.