On February 24, 2021 Epizyme, (Nasdaq: EPZM), a fully integrated, commercial-stage biopharmaceutical company developing and delivering novel epigenetic therapies, reported that it will host a call to discuss the Company’s strategic vision on Tuesday, March 2, 2021 at 10:00 a.m. ET (Press release, Epizyme, FEB 24, 2021, View Source [SID1234575555]).

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The Next EPIsode: Rewriting Oncology Treatment with Epigenetics

Date: Tuesday, March 2, 2021
Time: 10:00 – 11:30 a.m. ET

Program:

Epizyme 2021 and Beyond
The Role of Epigenetics in Oncology
Tazverik Development: The Next Chapter
The Future of Epizyme’s Epigenetics Pipeline
A link to register for the event is available here. A live webcast of the event can also be accessed through the investor section of the Company’s website at www.epizyme.com, and will be archived for 60 days following the call.

On February 24, 2021 Verity Pharmaceuticals reported that it has received a notice of compliance with conditions (NOC/c) from Health Canada for the VERITY-BCG (Bacillus Calmette-Guérin [BCG]: Strain Russian BCG-I) (Press release, veritypharma, FEB 24, 2021, View Source [SID1234605586]). This approval is welcome news for patients and health care providers who have endured a Canadian and global shortage of this important bladder cancer drug.

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Bacillus Calmette-Guérin (BCG) is a proven immunotherapy of choice for bladder cancer. It is used as first-line intravesical therapy following tumor resection of non-muscle-invasive bladder cancer. Primary producers of BCG announced shortages within the last decade, leading to a worldwide scarcity of the treatment. This new source of BCG from Verity Pharma is expected to be available by mid 2021.

"Canada’s multi-year BCG drug shortage will now be a thing of the past with this approval," said Howard Glase, Chief Executive Officer, Verity Pharma. "We know these drug shortages were leading to rationing and dose sparing of this crucial bladder cancer drug and patients had delayed or even cancelled treatments. Canadian patients will now have full access to this life-saving therapy."

According to an article by the National Centre for Biotechnology Information, "physicians treating patients affected by non-muscle invasive bladder cancer (NMIBC) have been in shock during the last six years since manufacturing restrictions on the production of the first-option medicine, Mycobacterium bovis Bacillus Calmette-Guérin (BCG), have resulted in worldwide shortages."i

Bladder Cancer Canada states that bladder cancer is the 5th most common cancer in Canada and almost 12,000 people will be diagnosed with bladder cancer this year alone.

Verity has partnered with Serum Institute of India, which manufactures BCG. Serum Institute is the world’s largest manufacturer of vaccines.

"Verity is proud to continue bringing critical drugs to Canadians. VERITY-BCG is an example of our expertise in supplying life-saving therapeutic options to help fulfill unmet patient needs," said Glase.

About VERITY-BCG

VERITY-BCG is an adjuvant therapy after transurethral resection (TUR) of a primary or relapsing superficial papillary urothelial cell carcinoma of the bladder stage Ta (grade 2 or 3) or T1 (grade 1, 2, or 3), without concomitant carcinoma in situ. It is only recommended for stage Ta grade 1 papillary tumors, when there is judged to be a high risk (>50%) of tumor recurrence.

More information is available here: View Source

On February 24, 2021 Seagen Inc. (Nasdaq: SGEN) reported that management will participate in a fireside chat at the Cowen 41st Annual Healthcare Conference on Monday, March 1, 2021 at 2:40 p.m. Eastern Time (Press release, Seagen, FEB 24, 2021, View Source [SID1234575524]). The presentation will be webcast live and available for replay from Seagen’s website at www.seagen.com in the Investors section.

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On February 24, 2021 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics, reported financial results for the quarter and full year ended December 31, 2020 (Press release, Guardant Health, FEB 24, 2021, View Source [SID1234575540]).

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Recent Highlights

Revenue of $78.3 million for the fourth quarter and $286.7 million for the full year of 2020, representing 25% and 34% increases, respectively, over the corresponding periods of 2019
Launched Guardant Reveal, the first blood-only test with a 7-day turnaround time, for residual disease and recurring monitoring in patients with early-stage colorectal cancer
Announced development of tissue-based Comprehensive Genomic Profiling assay to provide a comprehensive product offering to oncologists, and its launch later in 2021
Announced partnership with a premier cancer center in Spain, Vall d’Hebron Institute of Oncology, to build a liquid biopsy laboratory and submitted application for regulatory approval of Guardant360 in Japan
Strengthened balance sheet with $1 billion capital raise and ended 2020 with approximately $2 billion in cash, cash equivalents and marketable securities
"I am proud of the Guardant team for the progress made across our business amidst a uniquely challenging year," said Helmy Eltoukhy, PhD, co-founder and CEO. "Looking ahead in 2021, we will continue to invest aggressively across our business to build the foundations for complete cancer testing to significantly improve outcomes across the continuum of cancer care."

Fourth Quarter 2020 Financial Results

Revenue was $78.3 million for the three months ended December 31, 2020, a 25% increase from $62.9 million for the three months ended December 31, 2019. Precision oncology revenue grew 13% driven predominantly by an increase in clinical testing revenue which grew 47% over the prior year period. There were 17,353 clinical tests and 4,841 biopharmaceutical tests performed during the fourth quarter of 2020. Development services and other revenue increased 148% primarily related to the timing of project related milestones for companion diagnostic development programs.

Gross profit, or total revenue less cost of precision oncology testing and cost of development services and other, was $49.9 million for the fourth quarter of 2020, an increase of $8.9 million from $41.1 million for the corresponding prior year period. Gross margin, or gross profit divided by total revenue, was 64%, as compared to 65% for the corresponding prior year period.

Operating expenses were $141.1 million for the fourth quarter of 2020, as compared to $67.0 million for the corresponding prior year period, an increase of 110%.

Stock-based compensation expense was $56.8 million for the fourth quarter of 2020, as compared to $5.1 million for the fourth quarter of 2019.

Net loss attributable to Guardant Health, Inc. common stockholders was $93.7 million for the fourth quarter of 2020, as compared to $25.2 million for the corresponding prior year period. Net loss per share attributable to Guardant Health, Inc. common stockholders was $0.94 for the fourth quarter of 2020, as compared to $0.27 for the corresponding prior year period.

Non-GAAP adjusted EBITDA loss was $29.8 million for the fourth quarter of 2020, as compared to a $17.1 million loss for the corresponding prior year period.

Full Year 2020 Financial Results

Revenue for the year ended December 31, 2020 was $286.7 million, a 34% increase from $214.4 million for the year ended December 31, 2019. Precision oncology revenue increased 31% driven predominantly by an increase in clinical testing revenue which grew 70% over the prior year. There were 63,254 clinical tests and 15,983 biopharmaceutical tests performed during 2020. Development services revenue increased 49% primarily due to new collaboration agreements entered in the year ended December 31, 2020 as well as progression of existing collaboration projects from biopharmaceutical customers for companion diagnostic development and regulatory approval services completed during the year ended December 31, 2020.

Gross profit was $194.2 million for the year ended December 31, 2020, an increase of $50.5 million from $143.7 million for the year ended December 31, 2019. Gross margin was 68% for the year ended December 31, 2020, as compared to 67% for the year ended December 31, 2019.

Operating expenses were $449.1 million for the year ended December 31, 2020, as compared to $226.0 million for the year ended December 31, 2019, an increase of 99%.

Stock-based compensation expense was $144.1 million for the year ended December 31, 2020, as compared to $17.0 million for the year ended December 31, 2019.

Net loss attributable to Guardant Health, Inc. common stockholders was $253.8 million for the year ended December 31, 2020, as compared to $75.7 million for the year ended December 31, 2019. Net loss per share attributable to Guardant Health, Inc. common stockholders was $2.60 for the year ended December 31, 2020, as compared to $0.84 for the year ended December 31, 2019.

Non-GAAP adjusted EBITDA loss was $85.2 million for the full year of 2020, as compared to a $53.3 million loss for the corresponding prior year period.

Cash, cash equivalents and marketable securities were $2.0 billion as of December 31, 2020.

2021 Guidance

Guardant Health expects full year 2021 revenue to be in the range of $360 million to $370 million, representing 26% to 29% growth over full year 2020. Clinical volumes for 2021 are expected to be greater than 90,000 tests, growing at least 42% over 2020.

Webcast Information

Guardant Health will host a conference call to discuss the fourth quarter 2020 financial results after market close on Thursday, February 24, 2021 at 2:00 pm Pacific Time / 5:00 pm Eastern Time. A webcast of the conference call can be accessed at View Source The webcast will be archived and available for replay for at least 90 days after the event.

Non-GAAP Measure

We believe that the exclusion of certain income and expenses in calculating non-GAAP Adjusted EBITDA can provide a useful measure for investors when comparing our period-to-period core operating results, and when comparing those same results to that published by our peers. To derive Adjusted EBITDA, we remove from GAAP results the impact of income (expenses) attributable to material non-cash items, specifically stock-based compensation and fair value remeasurements due to the subjectivity, management judgment, and market fluctuations involved around these amounts. We exclude certain other items because we believe that these income (expenses) do not reflect expected future operating expenses. Additionally, certain items are inconsistent in amounts and frequency, making it difficult to perform a meaningful evaluation of our current or past operating performance.

This non-GAAP financial measure is not intended to be considered in isolation from, as substitute for, or as superior to, the corresponding financial measure prepared in accordance with GAAP. There are limitations inherent in non-GAAP financial measures because they exclude charges and credits that are required to be included in a GAAP presentation, and do not present the full measure of our recorded costs against its revenue. In addition, our definition of the non-GAAP financial measures may differ from non-GAAP measures used by other companies.

Definition of Non-GAAP Adjusted EBITDA

Non-GAAP "Adjusted EBITDA" is defined as net loss attributable to Guardant Health, Inc. common stockholders before: (i) interest income,(ii) interest expense (iii) provision for (benefit from) income taxes, (iv) depreciation and amortization expense, (v) other (income) expense, net, (vi) stock-based compensation expense, (vii) adjustments relating to non-controlling interest and contingent consideration and, if applicable in a reporting period, and (viii) acquisition-related expenses, and other non-recurring items.

On February 24, 2021 Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, reported the launch of the Twist NGS Methylation Detection System, a robust, end-to-end sample preparation and target enrichment solution for identifying methylated regions in the human genome (Press release, Twist Bioscience, FEB 24, 2021, View Source [SID1234575556]).

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DNA methylation plays a key role in many biological processes including cancer. When present on a single nucleotide, a methyl group can alter genetic behavior without changing the DNA sequence. Analyzing these methylation patterns provides unique understanding of disease pathology, including the ability to screen for cancer earlier using blood samples known as "liquid biopsies."

"Methylation is one of the most interesting and informative epigenetic modifications due to its wide-reaching effects, but historically it has been difficult to study efficiently," said Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience. "In partnership with New England Biolabs, we’ve developed a state-of-the-art system, to identify and accurately evaluate methylation patterns that enable our customers to create better tests and/or conduct research more efficiently. In addition, the superior results produced through this system provide incentive for our customers using SNP microarray technology to switch to using Twist products plus sequencing."

DNA methylation appears in consistent patterns across the genome, making it possible to assess multiple loci for a more specific and sensitive test. In cancer methylation, patterns appear early, providing an attractive approach for screening through revolutionary liquid biopsy tests, which are designed to detect a wide range of tumors from a single blood sample.

HelioHealth, an early access customer, is currently developing simple, accurate liquid biopsy tests for the detection of early-stage liver, colon, breast and lung cancers.

"The complex, very large panels needed to detect circulating tumor DNA early in the disease require expertise in design, robust coverage from minimal sample material, and exceptional sensitivity in detecting the change between differentially methylated regions," said Kenneth Chahine, Ph.D., J.D., CEO of HelioHealth. "After some trial and error with other systems, we found that the Twist NGS Methylation Detection System improved the efficiency and accuracy of all of our tests, providing the best data possible for rapid and early cancer detection."

Despite the promise of methylation detection, the approach presents many challenges, including the preparation of the blood sample and the need for multiple probes for each sequence of interest. For many years, bisulfite sequencing was considered the gold standard in methylation detection. While this method provides a quantitative readout with high throughput and single-base pair resolution, bisulfite treatment can degrade DNA samples substantially and result in specific areas not being detected, particularly for tests with a small relative volume of target DNA for study, as in liquid biopsies. In addition, effective methylation detection requires four different DNA probes for every target sequence of DNA, a substantial undertaking for complex diagnostic tests. In order to overcome these challenges, Twist has partnered with New England Biolabs (NEB), who have developed a novel, enzyme-based alternative to sodium bisulfite treatment, EM-seqTM, for preparation of samples for methylation analysis.

"We developed Enzymatic Methyl-seq, or EM-seq, using a combination of enzymes to achieve highly efficient and gentle conversion of 5mC and 5hmC for downstream identification using next generation sequencing," said Theodore Davis, executive director of Applications and Product Development at NEB. "Application of EM-seq to target enrichment workflows enables efficient analysis of methylation status in defined regions of the genome, with utility across a broad spectrum of areas that can impact human health. We are delighted to partner with Twist to expand the utility of EM-seq."

The Twist NGS Methylation Detection System begins with NEB’s EM-seq for preparation of enzymatically converted libraries, and includes the Twist Methylation Enhancer, Universal Blocker and FastHyb as well as the Twist NGS Custom Methylation Panels. The Custom Panels, a key component of the product, include DNA probes to capture all four potential sequences at a given site: methylated, unmethylated, sense and antisense, and offer the same fidelity, uniformity, and flexibility as Twist Custom Panels. Twist works with customers to create custom content unique to a particular area of focus, allowing flexibility not found using static array designs. This unique feature of the Twist System facilitates exploration of dynamic and cell-specific methylation targets or poorly understood targets found in more elusive noncoding regions at single base pair resolution.

About the Twist NGS Methylation Detection System

The Twist NGS Methylation Detection System offers state-of-the-art end-to-end methylation sequencing workflow for the improved detection of genomic methylation patterns. DNA methylation occurs when DNA methyltransferases add a methyl group to the cytosine residue of cytosine-phosphoguanine (CpG) dinucleotides. This modification contributes to a wide variety of biological processes by promoting genomic instability or transcriptional silencing. Affected processes include normal processes, like cellular differentiation, as well as abnormal ones, like carcinogenesis. Methylation levels vary substantially across the human genome, and differentially methylated regions (DMRs) can be used to identify certain cancers and other diseases.

About New England Biolabs

Established in the mid 1970’s, New England Biolabs, Inc. (NEB) is the industry leader in the discovery and production of enzymes for molecular biology applications and now offers the largest selection of recombinant and native enzymes for genomic research. NEB continues to expand its product offerings into areas related to PCR, gene expression, sample preparation for next generation sequencing, synthetic biology, glycobiology, epigenetics and RNA analysis. Additionally, NEB is focused on strengthening alliances that enable new technologies to reach key market sectors, including molecular diagnostics development. New England Biolabs is a privately held company, headquartered in Ipswich, MA, and has extensive worldwide distribution through a network of exclusive distributors, agents and eight subsidiaries located in Australia, Canada, China, France, Germany, Japan, Singapore and the UK. For more information about New England Biolabs, visit www.neb.com.

NEB and NEW ENGLAND BIOLABS are registered trademarks of New England Biolabs, Inc.