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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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On November 2, 2021 Bio-Techne Corporation (NASDAQ: TECH) reported inclusion in Inc.’s first annual Best-Led Companies list, an exciting 12-point measure of management excellence across the middle market — a select, data-driven list of the very strongest U.S. firms with revenue of $50 million to $2 billion (Press release, Bio-Techne, NOV 2, 2021, View Source [SID1234594239]). This novel program is the first Inc. recognition list to honor both public and private companies.

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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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The final list recognizes 250 companies that are agile enough to maneuver but also large enough to have a broad impact. These companies employ 35 million people, about one in four U.S. workers. All 250 have a successful track record with leadership teams that spur solid performance, create value, penetrate markets, engage with customers, and more.

To be considered for the list, each company had to fill out an application answering questions about its performance, executive team, and leadership. Applicants were then analyzed via an algorithm that identified the very best companies according to their leadership teams’ superlative accomplishments in four key areas: performance and value creation; market penetration and customer engagement; talent; and leadership team.

"We are honored to be recognized in Inc.’s inaugural list of Best-Led Companies," said Chuck Kummeth, Bio-Techne’s President and Chief Executive Officer. "This achievement reflects strong leadership at all levels of Bio-Techne. This leadership has been an integral part of our recent strong performance and positions the Company for continued growth going forward."

"This inaugural list of companies represents the remarkable midsized companies, both public and private, often founder-led, that are at the vanguard of reinventing American business," says Scott Omelianuk, editor-in-chief of Inc. magazine. "With their leadership, all business will benefit from an exciting, competitive future full of possibilities."

To compile the list, Inc. evaluated private and public U.S.-based companies with a 2020 revenue of $50 million to $2 billion or a valuation of $50 million to $10 billion using a proprietary 12-point measure of management excellence, generated with input from partners at Pitchbook and Shango Labs.

The November issue of Inc. magazine is available online now at View Source and will be on newsstands beginning November 9, 2021.

On November 2, 2021 Novo Nordisk reported that initiated a share repurchase programme in accordance with Article 5 of Regulation No 596/2014 of the European Parliament and Council of 16 April 2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052 of 8 March 2016 (the "Safe Harbour Rules") (Press release, Novo Nordisk, NOV 2, 2021, View Source [SID1234594203]). This programme is part of the overall share repurchase programme of up to DKK 18 billion to be executed during a 12-month period beginning 3 February 2021.

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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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Under the programme initiated 4 August 2021, Novo Nordisk has repurchased B shares for an amount up to DKK 3.3 billion in the period from 5 August 2021 to 1 November 2021. The programme is now concluded.

Since the announcement 25 October 2021, the following transactions have been made:

With the transactions stated above, Novo Nordisk owns a total of 22,633,347 B shares of DKK 0.20 as treasury shares, corresponding to 1.0% of the share capital. The total amount of A and B shares in the company is 2,310,000,000 including treasury shares.

Novo Nordisk expects to repurchase B shares for an amount up to DKK 18 billion during a 12- month period beginning 3 February 2021. As of 1 November 2021, Novo Nordisk has since 3 February 2021 repurchased a total of 23,826,181 B shares at an average share price of DKK 511.47 per B share equal to a transaction value of DKK 12,186,313,644.

On November 2, 2021 Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in genetic testing and precision medicine, reported financial results for its third quarter ended September 30, 2021 and provided an update on recent business performance and strategic transformation plans (Press release, Myriad Genetics, NOV 2, 2021, View Source [SID1234594202]).

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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 encouraged by our third quarter performance, and the execution of our teammates on our strategic growth and transformation plans that resulted in year-over-year growth in test volumes, margins and revenue," said Paul J. Diaz, President and Chief Executive Officer. "The quality and accuracy of our products and improving customer service levels continue to position our business for sustainable growth and profitability. I want to thank all of our 2,400 Myriad Genetics teammates for their commitment to advancing the health and well-being of all of our patients. We are encouraged by the growing market opportunities in our core businesses and see significant potential to expand access to quality genetic testing and precision medicines that improve health outcomes and access to needed healthcare services."

Financial and Operational Highlights:

Diagnostic test volumes of 252,000 increased 15% year-over-year. Sequential volume was impacted by constraints in access to healthcare providers due to the COVID-19 pandemic, the impact of the Delta variant strain, and typical summer seasonality.
Hereditary cancer volumes for the quarter were flat year-over-year and decreased 7% sequentially.
Prenatal test volumes in Women’s Health increased 7% year-over-year and decreased 10% sequentially.
Tumor profiling test volumes in Oncology increased 33% year-over-year and decreased 15% sequentially.
Pharmacogenomics test volumes in Mental Health increased 71% year-over-year and 6% sequentially.
Overall, average selling price (ASP) was stable year-over-year and sequentially after excluding positive revenue adjustments related to better-than-expected cash collections on tests ordered in prior periods.
Total revenue in the quarter was $167.3 million, an increase of 15% year-over-year.
Excluding the divested business revenue, RBM, Autoimmune and myPath, quarterly revenue increased 27% year-over-year.
The following table summarizes year-over-year revenue changes by product category:
GAAP gross margin in the quarter was 71.4%; adjusted gross margin was 71.7%, which improved 190 basis points year-over-year.
GAAP total operating expenses in the quarter were $199.4 million; adjusted total operating expenses decreased $1.6 million sequentially to $121.5 million.
GAAP operating loss in the quarter was $(79.9) million, declining $40.3 million year-over-year; adjusted operating loss was $(1.4) million, improving $10.7 million year-over year.
Diluted GAAP EPS in the quarter were $0.30, improving $0.50 year-over-year; adjusted EPS were $(0.02), improving $0.13 year-over-year.
Closed the sale of Myriad Autoimmune’s Vectra testing business on September 13, 2021.
Ended the quarter with $413.6 million in cash, cash equivalents and investments.
"While we still have a lot of hard work ahead of us, we are now better positioned for growth across all of our business segments as we look to 2022 and beyond," said Diaz. "Our balance sheet is strong. As a result, we can now focus on investing further in the opportunities we see in the emerging technologies, R&D and commercial strategies that elevate our products to their full potential including, acquisitions, new partnerships, and new business development efforts. We look forward to expanding access to vital genetic testing, and precision medicine, making it easier for patients and partners to engage with us, and delivering sustainable and profitable results for all of our shareholders."

Business Performance and Highlights:

Women’s Health
In the Myriad Women’s Health business, Myriad serves women assessing their risk of cancer, and those who are pregnant or planning a family. Women’s Health delivered revenue of $59.1 million in the quarter, an increase of 6% year-over-year and a decrease of 12% sequentially.

Hereditary Cancer
With the launch of the first polygenic breast cancer risk assessment score validated for women of all ancestries, Myriad further strengthened its industry-leading MyRisk Hereditary Cancer test and significantly expanded access to genetic testing. Now enhanced with RiskScore for all ancestries, MyRisk provides 5-year and lifetime breast cancer risk assessment for all women not previously diagnosed with breast cancer.
RiskScore results are informed by a combination of genetic markers, clinical and biological variables, personal and family history, and ancestry-specific data. RiskScore is available at no additional cost to women who take the MyRisk test.
Prenatal
The company continues to see increasing momentum from its Prequel noninvasive prenatal screening (NIPS) test including proprietary AMPLIFY technology, which dramatically enhances the test’s performance and works to reduce test failure rates so that patients may avoid unnecessary invasive procedures.
In late 2022, the company plans to launch a novel prenatal test that will deliver the clinical value of both Prequel and Foresight to more expectant parents. The novel offering will simplify the NIPS and carrier screening workflows, which currently involve several samples and different tests, and deliver key clinical content of Prequel and the Foresight carrier screen test from a single maternal sample. The combined offering will provide a single prenatal test that is simple, accurate and will allow more patients to get answers faster.
Oncology
Myriad’s Oncology business provides hereditary cancer testing, including MyRisk, for patients who have cancer. It also provides tumor profiling products such as the EndoPredict breast cancer prognostic test, the Prolaris prostate cancer test, and the myChoiceCDx companion diagnostic test for predicting response to PARP inhibitors. The Oncology business delivered revenue of $76.8 million in the quarter, an increase of 32% year-over-year and a decrease of 2% sequentially.

The company made progress towards launching its combined offering of somatic, germline and CDx for ovarian cancer patients.
The new offering, planned for launch in early 2022, combines Myriad’s leading germline hereditary cancer test (MyRisk), Myriad’s FDA approved companion diagnostic test (myChoiceCDx), together with a Myriad branded tumor profiling test powered by Illumina’s TSO500 and run by Intermountain’s Precision Genomics.
With Myriad’s new combined offering, patients and their healthcare providers will receive one comprehensive solution from one laboratory with one team of scientists interpreting the results thereby significantly improving the quality and ease of use of the results.
The combined product offering will be sold through the Myriad Oncology sales force throughout the entire U.S.
Mental Health
Myriad’s Mental Health business consists of the GeneSight psychotropic test that covers 61 medications commonly prescribed for depression, anxiety, ADHD, and other psychiatric conditions. In the pharmacogenomic category, GeneSight delivered revenue of $24.1 million in the quarter, an increase of 103% year-over-year and 7% sequentially.

GeneSight saw a strong increase in new ordering providers with nearly 2,700 physicians ordering GeneSight for the first time in the quarter. The total number of ordering physicians increased 6% sequentially.
The Mental Health business has successfully implemented its ongoing commercial transformation with the rightsizing of its field sales force, growing its inside sales force, and executing a robust digital marketing plan to meet patients and clinicians where they are searching for mental health treatments online.
Business Divestitures
On July 1, 2021, the company completed the sale of its wholly-owned subsidiary, Myriad RBM, Inc. to Q2 Solutions.

Gross proceeds of $197.0 million in cash.
Recognized gain on sale of assets of $121.0 million.
On September 13, 2021, the company completed the sale of select operating assets and intellectual property, including the Vectra test, to Laboratory Corporation of America Holdings.

Gross proceeds of $150.0 million in cash.
Recognized loss on sale of assets of $0.6 million.
Recognized loss on inventory of $11.7 million.
The company recorded $48.0 million for the potential qui tam settlement against Crescendo Bioscience, Inc.
The company intends to use a portion of the total divestiture gross proceeds of approximately $380.0 million to fund investments in technology and commercial efforts and fund the potential qui tam settlement relating to Crescendo Bioscience, Inc. The proceeds were also used to paid down its revolving credit facility.

Financial Guidance
Given the continued unpredictability surrounding the COVID-19 pandemic (and its variant strains) as well as the impact it continues to have on the healthcare environment, customer behavior and the ability to market tests to physicians, the company will not provide financial guidance for the fourth quarter ending December 31, 2021 or fiscal year 2021. We expect to resume providing financial guidance in early 2022.

Conference Call and Webcast
A conference call will be held today, Tuesday, November 2, 2021, at 4:30 p.m. EDT to discuss Myriad’s financial results and business developments for the third quarter 2021. The dial-in number for domestic callers is 1-800-920-2776. International callers may dial 1-212-271-4651. All callers will be asked to reference reservation number 21998401. An archived replay of the call will be available for seven days by dialing 1-800-633-8284 and entering the reservation number above. The conference call and slide presentation will be available through a live webcast at www.myriad.com.

On November 2, 2021 Atreca, Inc. (Atreca) (NASDAQ: BCEL), a clinical-stage biotechnology company focused on developing novel therapeutics generated through a unique discovery platform based on interrogation of the active human immune response, reported financial results for the third quarter ended September 30, 2021, and provided an overview of recent developments (Press release, Atreca, NOV 2, 2021, View Source [SID1234594201]).

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"In the third quarter, we continued to advance our lead program, ATRC-101, following the release of initial summary data from the dose escalation portion of the Phase 1b trial, which supports the further evaluation of ATRC-101 in multiple solid tumor types," said John Orwin, Chief Executive Officer. "We plan to share additional monotherapy data and initial combination data with pembrolizumab in 2022, and are in a strong position to advance our pipeline with cash runway through mid-2023."

"Our earlier-stage programs are progressing well, highlighted by our recently announced licensing agreement with the Bill & Melinda Gates Medical Research Institute for the development and commercialization of MAM01/ATRC-501, a novel monoclonal antibody entering preclinical development for the prevention of malaria," said Tito Serafini, Ph.D., Chief Strategy Officer. "We look forward to sharing more information on our EphA2 program and other pipeline assets at an R&D day early next year."

Recent Developments and Highlights

Atreca announced a licensing agreement with the Bill & Melinda Gates Medical Research Institute ("Gates MRI") for development and commercialization of MAM01/ATRC-501, a monoclonal antibody for malaria prophylaxis. Under the agreement, Gates MRI will lead the development of MAM01/ATRC-501 and receive commercial rights in GAVI-eligible countries located in malaria-endemic regions of the world, while Atreca will retain commercial rights in the U.S., Europe and parts of Asia. Potential product development opportunities for Atreca include developing MAM01/ATRC-501 for prevention of malaria for those traveling to regions where the infection may be circulating.
Enrollment in the monotherapy portion of the Phase 1b trial of ATRC-101 is ongoing at 30 mg/kg and Atreca plans to report additional monotherapy data in mid-2022.
Enrollment has commenced in a Phase 1b combination cohort evaluating ATRC-101 with pembrolizumab. Another combination cohort with pegylated liposomal doxorubicin ("PLD") is expected to begin enrolling patients following completion of ongoing monotherapy cohorts, including those following a Q2W dosing schedule which better aligns with the standard PLD regimen. Atreca plans to report additional monotherapy data in mid-2022 and pembrolizumab combination data in 3Q22.
Third Quarter 2021 Financial Results

As of September 30, 2021, cash and cash equivalents and short-term investments totaled $152.9 million.

Research and development expenses for the three months ended September 30, 2021 were $18.7 million, including non-cash share-based compensation expense of $1.9 million.

General and administrative expenses for the three months ended September 30, 2021 were $8.8 million, including non-cash share-based compensation expense of $1.9 million.

Atreca reported a net loss of $27.4 million, or basic and diluted net loss per share attributable to common stockholders of $0.74, for the three months ended September 30, 2021