On May 3, 2021 Exact Sciences Corp. (Nasdaq: EXAS) reported that company management will participate in the following conferences and invited investors to participate by webcast (Press release, Exact Sciences, MAY 3, 2021, View Source [SID1234579008]).

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BofA Securities Virtual Healthcare Conference
Fireside Chat on Wednesday, May 12, 2021 at 1:15 p.m. EDT

UBS Global Healthcare Virtual Conference
Fireside Chat on Tuesday, May 25, 2021 at 4:00 p.m. EDT
The webcasts can be accessed in the investor relations section of Exact Sciences’ website at www.exactsciences.com.

On May 3, 2021 Geron Corporation (Nasdaq: GERN) reported that it will release its first quarter 2021 financial results after the market closes on Monday, May 10, 2021 via press release, which will be available on the Company’s website at www.geron.com/investors (Press release, Geron, MAY 3, 2021, View Source [SID1234579007]). Geron will host a conference call to discuss the financial results as well as recent events at 4:30 p.m. ET the same day.

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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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A live, listen-only webcast will be available on the Company’s website at www.geron.com/investors/events. An archive of the webcast will be available on the Company’s website for 30 days.

Participants may access the conference call live via telephone by pre-registering online using the following link, View Source Upon registration, a phone number, Direct Event Passcode and unique Registrant ID will be sent via email. This information will be needed in order to enter the conference call. Participants are advised to pre-register at least 10 minutes prior to joining the call.

On May 3, 2021 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") platform to transform oncology drug discovery and development reported financial results for the first quarter ended March 31, 2021 (Press release, Lantern Pharma, MAY 3, 2021, View Source [SID1234579006]).

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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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"We are very pleased with our continued rapid progress in expanding and advancing our pipeline of targeted cancer drug candidates and are on pace to launch the Phase 2 trial of LP-300 in non-small cell lung cancer among non-smokers in the third quarter of this year," stated Panna Sharma, President and CEO of Lantern Pharma. "During the first quarter, we dramatically accelerated the pace with which we gather, curate, tag and assemble biologically relevant data for our RADR A.I. platform. Our RADR A.I. platform now exceeds 4.6 billion datapoints, representing a nearly 16-fold increase in the number of datapoints since our IPO in June 2020. RADR grew by approximately 1 billion datapoints per month during the first quarter of 2021. The size and scope of our RADR A.I. platform is opening up new insights and areas of opportunity for the discovery of additional indications for our existing drug candidates, as well as the identification of entirely new drug candidates and new therapeutic indications for existing molecules in the fight against cancer."

"Perhaps most exciting, as our RADR A.I. platform grows, potential partnerships with biopharma companies are now even more clearly in our sights," continued Sharma. "Earlier today, we announced that we have entered into an equity-based collaboration with Actuate Therapeutics to apply the remarkable power of RADR to better understand the mechanism of action of Actuate’s 9-ING-41 drug candidate and utilize these insights to advance a biomarker signature of response and a biomarker guided development strategy. We are excited about the opportunity to continue to build additional value-driven partnerships in the quarters ahead."

The collaboration will focus on leveraging the RADR machine learning technology, large-scale oncology datasets, and the A.I. platform to accelerate key aspects of Actuate’s 9-ING-41 drug candidate, a best-in-class GSK-3β inhibitor in active development in multiple Phase 2 clinical trials, including for pancreatic cancer. The collaboration is expected to start immediately and will potentially generate novel intellectual property that will be jointly owned by the companies. Lantern will receive upfront equity in Actuate Therapeutics subject to meeting certain conditions of the collaboration, as well as development milestones in the form of additional equity if results from the collaboration are utilized in future development efforts.

Lantern is developing four drug candidates and an ADC program across seven disclosed targets, including:

●LP-100 (Irofulven), in a Phase 2 trial for the treatment of metastatic castration resistant prostate cancer (mCRPC) which is out-licensed to Allarity Therapeutics.

●LP-300, a small molecule candidate that is preparing to enter a Phase 2 trial as a combination therapy in non-smokers with Non-Small Cell Lung Cancer (NSCLC).

●LP-184, a small molecule DNA damaging candidate anticipated to enter clinical development in 1H’22, with opportunities in several genomically-defined cancers, including: prostate, pancreatic, glioblastoma multiforme (GBM), atypical teratoid rhabdoid tumors (ATRT) and potentially additional tumors defined by the overexpression of PTGR1.

●LP-284, an alkylating agent in the research optimization stage, that appears to be preferentially active in certain hematologic cancers.

●Antibody Drug Conjugate (ADC) program leveraging RADR A.I. to identify targeted or therapeutic antibodies and aimed at utilizing a unique library of linkers to conjugate with LP-184 and other compounds.

First Quarter 2021 Financial Highlights

-Cash Position: Cash and cash equivalents were $81.4 million as of March 31, 2021 compared to $19.2 million as of December 31, 2020. The increase in cash and cash equivalents reflects the proceeds from our January 20, 2021 follow-on public offering with gross proceeds of $69.0 million.

-R&D Expenses: Research and development expenses were $1,279,037 for the quarter ended March 31, 2021, compared to $137,104 for the quarter ended March 31, 2020. The increase was primarily attributable to increases in research studies, expansion of the company’s research team, and research and development related stock option compensation expense of approximately $116,000 (a non-cash item) for the quarter ended March 31, 2021.

-G&A Expenses: General and administrative expenses were $1,173,258 for the quarter ended March 31, 2021, compared to $340,172 for the quarter ended March 31, 2020. The increase was primarily attributable to expenses associated with operating as a public company and general and administrative related stock option compensation expense of approximately $130,000 (a non-cash item) for the quarter ended March 31, 2021.

-Net Loss: Net losses were $2,452,295 for the quarter ended March 31, 2021, or $0.24 per share, compared to a net loss of $477,276 for the quarter ended March 31, 2020, or $0.24 per share. The net loss includes non-cash expenses related to employee stock options of approximately $246,000 for the quarter ended March 31, 2021.

Mr. Sharma concluded, "We will continue to aggressively advance our portfolio, both clinically and in new preclinical indications, and continue to leverage our A.I. platform to uncover new rescue or repurposing opportunities on our own or with partners. Our team is committed to building Lantern into a best-of-breed biopharma company that transforms the cost, pace and risk of oncology drug development by leveraging insight from our RADR A.I. platform with the experience and expertise of our cancer-focused research team and a roster of collaborations with world-renowned cancer research institutions. Our financial position has never been stronger and our portfolio of targeted oncology drug candidates is positioned to deliver significant ongoing value for shareholders."

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 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.