On May 3, 2021 CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics to treat chronic diseases and extend healthy lifespan, reported that the company will release its first quarter 2021 financial results after the market closes on Monday, May 17, 2021 (Press release, CohBar, MAY 3, 2021, View Source [SID1234579020]). Management will host a conference call with a slide presentation at 5:00 p.m. ET (2:00 p.m. PT) on the same day to provide an update on the company’s business.

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Details for the Conference Call and Slide Presentation:

Please visit View Source and enter password CWBR, or
Go to www.cohbar.com and click on Q1 2021 Shareholder Presentation at the top of homepage.
Please note, the conference audio will only be available by dial-in and not through Zoom.
For individuals participating in the Investor Call and Slide Presentation, please call into the conference audio and log into Zoom approximately 10 minutes prior to its start.

An audio replay of the call will be available beginning at 8:00 p.m. Eastern Time on May 17, 2021, through 11:59 p.m. Eastern Time on June 7, 2021. To access the recording please dial (844) 512-2921 in the U.S. and Canada, or (412) 317-6671 internationally, and reference Conference ID# 13718702. The audio recording along with the slide presentation will also be available at www.cohbar.com during the same period.

On March 3, 2021 Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in genetic testing and precision medicine, reported financial results for its quarter ended March 31, 2021 and provided an update on recent business performance (Press release, Myriad Genetics, MAY 3, 2021, View Source [SID1234579004]).

Financial Highlights:
Myriad Genetics delivered total revenue in the quarter of $173.1 million which grew 6% year-over-year and increased 12% sequentially from the fiscal quarter ending December 31, 2020.

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Total test volumes of 236,000 declined 1% year-over-year but increased 5% sequentially. Average U.S. revenue per test increased 2% sequentially, reflecting an increasingly stable pricing environment. Average selling prices benefitted in the quarter from Medicare back pay revenue for the Prolaris test for prostate cancer.
GAAP gross margin was 70.9% and adjusted gross margin was 71.5%. Adjusted gross margin improved 140 basis points sequentially, impacted positively by test pricing and negatively by increased revenue mix from prenatal testing and lower margin pharmaceutical and clinical service revenue.
GAAP total operating expenses were $169.5 million. Total adjusted operating expenses increased $1.3 million year-over-year to $127.0 million.
GAAP operating loss in the quarter was ($46.7) million; adjusted operating loss of ($3.3) million.
GAAP earnings per share (EPS) were ($0.52); adjusted EPS were ($0.06) which improved by $0.06 sequentially.
Free cash flow in the quarter was $64.7 million and was driven by a significant federal tax refund of approximately $90 million. The company ended the quarter with $188.0 million in cash, cash equivalents and investments and $157.0 million drawn on its revolving credit facility.
Business Performance and Highlights

Women’s Health
The Myriad Women’s Health business — which serves women assessing their risk of cancer, and those who are pregnant or planning a family — recorded revenue of $55.2 million in the quarter, a decline of 15% year-over-year. Elective testing for hereditary cancer has been negatively impacted by the COVID-19 pandemic due to delayed elective office visits. The company’s prenatal business continued to demonstrate strong growth trends with test volumes increasing 9% year-over-year and 7% sequentially.

Myriad myRisk Hereditary Cancer
myRisk Hereditary Cancer test volumes for the Women’s Health business in the U.S. declined 25% year-over-year largely due to the impact of the pandemic.
Myriad Foresight Carrier Screen and Myriad Prequel Prenatal Screen
Myriad’s proprietary AMPLIFY technology, which further increases the performance of its Prequel noninvasive prenatal screening (NIPS) test, is leading to increased new prenatal users and test utilization. Since the launch of the AMPLIFY technology in July, Myriad has seen an increase of 12% in the total number of ordering providers for prenatal testing services, including Prequel and Foresight, with 11% growth in total test utilization per provider.
Oncology
The Myriad Oncology business provides hereditary cancer testing for patients who have cancer, and products such as the EndoPredict breast cancer prognostic test, the Prolaris prostate cancer test, and the myChoice CDx and BRACAnalysis CDx companion diagnostic tests for predicting response to PARP inhibitors. The Oncology business delivered total revenue of $75.6 million, up 39% relative to revenue in the March quarter of last year.

Myriad myRisk Hereditary Cancer
myRisk Hereditary Cancer test volumes for the Oncology business in the U.S. declined 9% year-over-year.
Myriad Prolaris Prostate Cancer
Presented new data at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Conference demonstrating the Prolaris test can accurately predict which patients will benefit from multi-modality therapy. Using the newly established threshold, 27% of men with newly diagnosed high-risk disease and 73% with unfavorable intermediate-risk disease could avoid multimodality therapy.
Myriad BRACAnalysis CDx and myChoice CDx
Saw significant increases in BRACAnalysis CDx and myChoice CDx test volume in Japan with total revenue from the country increasing more than four-fold year-over-year to $11.9 million.
Received new reimbursement for the myChoice diagnostic system in Japan effective January 1, 2021.
New Tumor Profiling Product:
Announced new partnership with Intermountain Precision Genomics, powered by technology from Illumina (NASDAQ: ILMN), for a comprehensive offering of germline and somatic tumor testing services. The strategic collaboration combines germline genetic testing, next-generation tumor sequencing and world-class testing capabilities to elevate global precision oncology care.
Mental Health
Myriad’s Mental Health business — which consists of the GeneSight psychotropic test that helps physicians understand how genetic alterations impact response to antidepressant and other psychotropic medications — saw revenue of $17.6 million in the quarter compared to $20.4 million in the same period last year. Test volume for GeneSight was up 17% sequentially.

Myriad GeneSight
Saw a strong increase in new ordering providers with over 2,600 physicians ordering GeneSight for the first time in the quarter, up 24% sequentially. Overall, the number of ordering physicians increased 10% sequentially and test utilization per provider increased 4% sequentially despite the strong growth in new ordering providers.
Published a new study in Psychiatry Research demonstrating that the combinatorial approach available in the GeneSight Psychotropic test is better than single-gene testing at predicting patient outcomes and medication blood levels.
Autoimmune
Myriad’s Autoimmune business — which consists of the Vectra test for measuring disease activity in rheumatoid arthritis — generated revenue of $10.7 million in the quarter compared to $10.5 million in the same period last year.

Vectra
Signed a definitive agreement to sell select operating assets and intellectual property (IP), including the Vectra test, from Myriad Autoimmune’s business unit to Laboratory Corporation of America Holdings (NYSE: LH) for $150.0 million in cash. The deal is expected to close by the end of the third quarter of calendar year 2021.
Other
Other revenue – comprised of Myriad RBM contract research services for the pharmaceutical industry and the myPath Melanoma diagnostic test in dermatology — was $14.0 million in the March quarter versus $14.0 million in the same period in the prior year.

Signed a definitive agreement to sell the Myriad myPath, LLC, Laboratory, which is the laboratory that offers the myPath Melanoma test, to Castle Biosciences, Inc. for $32.5 million in cash. The transaction is expected to close in the second quarter of calendar year 2021.
The company generated $2.5 million in the quarter from COVID-19 testing services. Given the declining demand for testing in the United States, Myriad does not expect to have significant COVID-19 testing revenue going forward.
Investor Day
Myriad will host an Investor Day tomorrow, May 4, 2021 at 11:00 am EDT, to provide an update on its transformation plan and growth initiatives. The Investor Day will be a virtual event hosted on the company’s website. The link to the Investor Day event and registration is under the investor relations section of the website.

Financial Guidance
Given the continued unpredictability surrounding the COVID-19 pandemic and the impact it has had on the healthcare environment, customer behavior and the ability to market tests to physicians, the company will not provide financial guidance for the quarter ending June 30, 2021 or fiscal year 2021.

On May 3, 2021 Vivacitas Oncology, Inc. ("Vivacitas" or the "Company"), a clinical stage biopharmaceutical company focused on tough to treat cancers, and Image Analysis Group ("IAG"), a leading global medical imaging company, reported that iare collaborating to apply Artificial Intelligence (AI) technology and advanced imaging strategies to further the development of AR-67, a third generation Camptothecin, in patients with recurrent glioblastoma multiforme (reGBM) (Press release, Vivacitas Oncology, MAY 3, 2021, View Source [SID1234579021]).

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Advanced imaging techniques could play a critical role in response assessment in developing new and innovative cancer therapies. Multiparametric magnetic resonance imaging (mpMRI) provides quantitative non-invasive imaging markers of early therapy-related changes. IAG is deploying its proprietary, cloud-based imaging approach to provide scientific evidence of early therapy response.

Tina Runk, Vivacitas co-founder and Executive Vice President of Clinical Operations stated, "Working with IAG, we performed a retrospective analysis of imaging data from our Phase 2 clinical study of AR-67 activity in recurrent GBM, in which their technology was applied to assess pseudoprogression from true progression of disease. This assessment capability demonstrates the benefit of potentially including this technology in future pivotal clinical trials and treatment regimens to ensure patient retention based on more detailed and objective criteria."

Dr. Diana Dupont-Roettger, the Chief Scientific Alliance Officer at IAG stated, "We are excited to bring the latest and most impactful imaging strategies to Vivacitas to ensure a scientific excellence and efficient drug development process."

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.