On November 23, 2020 Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, reported financial results and business highlights for the fourth quarter and full year fiscal 2020 ended September 30, 2020 (Press release, Twist Bioscience, NOV 23, 2020, View Source [SID1234571596]).

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"We ended our fiscal year with record revenue and orders against the backdrop of a global pandemic and significant uncertainty," said Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience. "While we are proud of the new products we introduced to aid in the fight against COVID-19, which complemented our revenue, it was our core synthetic biology and next-generation sequencing (NGS) product lines that drove our overarching success.

"We have aggressive plans for growth and expansion in fiscal 2021 and beyond, continuing to build our foundation for sustained success across synthetic biology, NGS, biopharma and DNA data storage."

FISCAL 2020 FINANCIAL RESULTS

Orders: Total orders received for fiscal 2020 were $116.7 million compared to $70.0 million for fiscal 2019.
Revenue: Total revenues were $90.1 million for fiscal 2020 compared to $54.4 million for fiscal 2019.
Cost of Revenues: Cost of revenues for fiscal 2020 was $61.4 million compared to $47.4 million for fiscal 2019.
Research and Development Expenses: Research and development expenses for fiscal 2020 were $43.0 million compared to $35.7 million for fiscal 2019.
Selling, General and Administrative Expenses: Selling, general and administrative expenses for fiscal 2020 were $103.3 million compared to $80.1 million for fiscal 2019.
Net Loss: Net loss for fiscal 2020 was $139.9 million, or $3.57 per share, compared to $107.7 million, or $3.92 per share, for fiscal 2019.
Cash Position: As of September 30, 2020, the company had $290.0 million in cash, cash equivalents and short term investments.
FISCAL 2020 FOURTH QUARTER FINANCIAL RESULTS

Orders: Total orders received for the fourth quarter of fiscal 2020 were $42.7 million, compared to $20.0 million for the same period of fiscal 2019.
Revenue: Total revenues were $32.4 million for the fourth quarter of fiscal 2020 compared to $15.7 million for the same period of fiscal 2019.
Cost of Revenues: Cost of revenues for the fourth quarter of fiscal 2020 was $17.6 million compared to $12.4 million for the same period of fiscal 2019.
Research and Development Expenses: Research and development expenses for the fourth quarter of fiscal 2020 were $11.7 million compared to $10.5 million for the same period of fiscal 2019.
Selling, General and Administrative Expenses: Selling, general and administrative expenses for the fourth quarter of fiscal 2020 were $27.2 million compared to $24.4 million for the same period of fiscal 2019.
Net Loss: Net loss for the fourth quarter of fiscal 2020 was $24.3 million, or $0.54 per share, compared to $31.2 million, or $0.96 per share, for the fourth quarter of fiscal 2019.
"Over the last year, we delivered on revenue, orders, margin and product pipeline in a very challenging environment," commented Jim Thorburn, CFO of Twist. "We have a strong balance sheet and momentum moving into fiscal 2021, and look forward to an exciting year ahead."

Fiscal Fourth Quarter 2020 and Recent Highlights

Shipped products to approximately 2,200 customers in fiscal 2020, versus approximately 1,300 in fiscal 2019.
Presented data on our Twist Custom Target Capture Panel, Fast Hybridization Enrichment System and our Target Enrichment for Infectious Disease at the American Society of Human Genetics 2020 Annual Meeting.
Announced broad strategic partnership with Neogene Therapeutics, Inc. to leverage Neogene’s proprietary expertise in targeting tumor neo-antigens, mutated proteins found in cancer cells due to cancer-associated DNA mutations, together with Twist’s DNA synthesis platform and product lines to develop personalized chimeric antigen receptor (CAR) T cell therapies and T cell receptor (TCR) therapies for patients with cancer.
Reported preclinical data demonstrating the potent neutralizing effects of multiple potential therapeutic antibodies identified by Twist Biopharma, both Immunoglobulin G (IgG) antibodies and substantially smaller single domain VHH "nanobodies," against SARS-CoV-2, the virus that causes COVID-19. These neutralizing effects were found to be comparable to or better than those seen with antibody candidates derived from patients who had recovered from COVID-19. The data were collected from studies conducted by Saint Louis University and independently verified by scientists at Colorado State University.
Achieved significant milestones on our DNA data storage roadmap to miniaturize the silicon platform technology down to 150 nanometer pitch or less. Twist is now consistently able to synthesize DNA using five-micron devices at a 10 micron pitch. In addition, we have fabricated our next R&D-stage silicon chip with 300 nanometer devices on a one-micron pitch chip.
Formed the DNA Data Storage Alliance with leading technology and synthetic biology companies to create a comprehensive industry roadmap designed to help the industry achieve interoperability between solutions and help establish the foundations for a cost-effective commercial archival storage ecosystem for the explosive growth of digital data.
New Netflix Original Series ’Biohackers’ stored in Twist’s synthetic DNA.
Fiscal 2021 Financial Guidance

The following statements are based on Twist’s current expectations for fiscal 2021. The following statements are forward-looking, and actual results could differ materially depending on market conditions and the factors set forth under "Forward-Looking Statements" below. Twist does not plan to update, nor does it undertake any obligation to update, this outlook in the future.

For the full fiscal year 2021, Twist provided the following financial guidance:

Revenue expected in the range of $110 million to $118 million
Revenue from Ginkgo Bioworks expected to be approximately $11 to $12 million
Synbio revenue excluding Ginkgo Bioworks is expected to be in the range of $41 to $44 million
NGS revenue is estimated to be in the range of $54 to $58 million
Biopharma revenue is estimated to be approximately $4 million
Gross margin is expected to be approximately 32% for fiscal 2021
Operating expenses including R&D and SG&A are expected to be $174 million for the year
Net loss expected in the range of $136 million to $141 million to reflect our increased investments in our commercial organization and research and development activities
R&D is expected to be approximately $60 million
Stock-based compensation is expected to be approximately $20 million
Depreciation is expected to be $7 million
Capital expenditures are expected to be $30 million, including expansion into "Factory of the Future"
Fiscal 2021 First Quarter Financial Guidance

For the first quarter of fiscal 2021, Twist provided the following financial guidance:

Revenue expected in the range of $25 million to $26 million
COVID-19 Considerations

During the three months ended September 30, 2020, financial results of the Company were not significantly affected by the COVID-19 outbreak. However, the extent to which the COVID-19 outbreak affects Twist’s future financial results and operations is subject to a high degree of uncertainty and will depend on future developments, including the duration, spread and treatment of the outbreak domestically and abroad.

Conference Call Information

The company plans to hold a conference call and live audio webcast for analysts and investors today at 8:00 a.m. Eastern Time to discuss its financial results and provide an update on the company’s business. The call can be accessed by dialing (866) 688-0947 (domestic) or (409) 217-8781 (international) and refer to the conference ID 2947139. A telephonic replay of the conference call will be available beginning approximately four hours after the call through November 30, 2020 and may be accessed by dialing (855) 859-2056 (domestic) or (404) 537-3406 (international). The replay conference ID is 2947139. The webcast replay will be available for two weeks.

Given the circumstances globally, it is recommended to dial-in at most 15 to 20 minutes prior to the call start to reduce waiting times. If a participant will be listen-only, they are encouraged to listen via the webcast on Twist’s investor page.

On November 23, 2020 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported the publication of a second abstract at the San Antonio Breast Cancer Symposium (SABCS), jointly authored by Professor Mothaffar F. Rimawi, the Global Principal Investigator of the GP2 Phase III clinical trial, and the Executive Medical Director and Co-Leader of the Breast Cancer Program at the Dan L Duncan Comprehensive Cancer Center at Baylor College of Medicine, and Professor C. Kent Osborne, Tina and Dudley Sharp Chair in Oncology and the founding Director of the Dan L Duncan Comprehensive Cancer Center at Baylor College of Medicine (Press release, Greenwich LifeSciences, NOV 23, 2020, View Source [SID1234571595]). The abstract will be displayed as the Company’s second poster on Wednesday, December 9, 2020 in a virtual format with an introductory audio track.

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The abstract highlights the design of the planned Phase III clinical trial. The trial is designed as a single registration trial that will include an interim analysis seeking conditional marketing approval from the FDA upon the interim analysis data read out followed by submission of a Biologics Licensing Application. The Phase III clinical trial aims to reproduce the Phase IIb study which concluded that completion of the first 6 intradermal injections of GP2 + GM-CSF safely elicited a potent immune response and reduced recurrence rates to 0% in HER2/neu 3+ patients, who received a standard course of trastuzumab after surgery.

Snehal Patel, CEO of Greenwich LifeSciences, commented, "The participation of Baylor College of Medicine as the Phase III clinical trial lead site further validates the significance of our Phase IIb data. Reducing the recurrence of breast cancer rates to 0% gives us great confidence as we try to reproduce this data in the Phase III clinical trial. We are addressing a potential market of up to $5 billion in a disease that affects 1 in 8 women, who if recur, will likely face metastatic breast cancer."

"We are very excited to be working with such prominent key opinion leaders. Professor Rimawi’s leadership of our Phase III clinical trial will complement the positive Phase IIb clinical trial results with the research and clinical expertise of Baylor College of Medicine. Due to GP2’s efficacy and safety profile, GP2 immunotherapy may provide clinicians with an option to reduce the use of other toxic and expensive treatments. We look forward to sharing our Phase IIb clinical trial data and Phase III clinical trial design with breast cancer leaders attending SABCS and to discussing the participation of their clinical sites in our trial," Patel concluded.

The Phase III clinical trial will explore the use of GP2 + GM-CSF as adjuvant therapy to prevent the recurrence of breast cancer in HER2/neu positive and HLA 2+ patients, post-surgery and following the first year of treatment with any trastuzumab-based therapy.

The Phase III clinical trial is a prospective, randomized, double-blinded, multi-center study. After 1 year of trastuzumab-based therapy or an approved biosimilar, treatment with GP2 + GM-CSF or placebo will be administered intradermally for the 6 primary immunization series over the first 6 months and 5 subsequent boosters over the next 2.5 years for a total of 11 injections over 3 years of treatment. The participant duration of the trial will be 3 years of treatment plus 2 years of follow-up for a total of 5 years following the first year of treatment with trastuzumab-based therapy or approved biosimilar. An interim analysis is planned and patients will be stratified based on prior and current treatments, among other factors.

The majority of breast cancer patients will be HER2/neu positive and HLA 2+, disease-free, conventionally treated node-positive, post breast tumor removal surgery and following the first year of treatment with trastuzumab-based therapy.

Abstract OT-13-03 is entitled: A prospective, randomized, multicenter, double-blinded, placebo-controlled Phase III trial of the HER2/neu peptide GP2 + GM-CSF versus bacteriostatic saline/WFI placebo as adjuvant therapy after any trastuzumab-based therapy in HER2-positive women with operable breast cancer. The full abstract can be viewed here on page 912.

About SABCS

The 43rd annual SABCS has grown to be the industry’s premier breast cancer conference for basic, translational, and clinical cancer research professionals. It is well-known for presenting the latest breast cancer data from all over the world. More than 7,500 health care professionals from more than 90 countries attend annually. Baylor College of Medicine became a joint sponsor of SABCS in 2005. The Cancer Therapy & Research Center at UT Health Science Center San Antonio and American Association for Cancer Research (AACR) (Free AACR Whitepaper) began collaborations with SABCS in 2007. For more information, please visit the conference website at: View Source

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 266,000 new breast cancer patients and 3.1 million breast cancer survivors in 2018. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

On November 23, 2020 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, reported it will conduct a conference call with investors to review financial results for its third quarter ended September 30, 2020, and provide an update on clinical and corporate developments, including its advanced stage drug candidates Piclidenoson and Namodenoson (Press release, Can-Fite BioPharma, NOV 23, 2020, View Source [SID1234571594]).

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A press release reviewing the third quarter results and clinical updates will be issued prior to the call. A replay of the webcast will be archived on Can-Fite’s website for a period of time.

On November 23, 2020 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading clinical-stage precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics, reported that Lloyd M. Segal, President and Chief Executive Officer, will participate in a fireside chat at the Piper Sandler 32nd Annual Virtual Healthcare Conference, being held November 30 – December 3, 2020 (Press release, Repare Therapeutics, NOV 23, 2020, View Source [SID1234571593]).

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A recording of the fireside chat is currently available in the Investor section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 90 days.

On November 23, 2020 Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) ("Eagle" or the "Company") reported that the Company’s pre-recorded presentation at the Piper Sandler 32nd Annual Virtual Healthcare Conference is now available for viewing via the link below (Press release, Eagle Pharmaceuticals, NOV 23, 2020, View Source [SID1234571592]):

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View Source

It is also available on the Company’s website at www.eagleus.com, under the Investors section, where it will be archived for 30 days.

Scott Tarriff, Chief Executive Officer, and Brian Cahill, Chief Financial Officer, will be participating in 1×1 meetings on December 1, 2020. Meetings can be requested exclusively via Piper Sandler.