On November 23, 2020 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported that management will participate in the Piper Sandler 32nd Annual Virtual Healthcare Conference, December 1-3, 2020 (Press release, Castle Biosciences, NOV 23, 2020, View Source [SID1234571605]). Derek Maetzold, president and chief executive officer, and Frank Stokes, chief financial officer, will provide a pre-recorded investor presentation and will be available for virtual one-on-one investor meetings during the conference.

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Meetings may be requested exclusively through Piper Sandler. The pre-recorded company presentation will be available via the Piper Sandler conference site from November 23 to December 3 and on the Castle Biosciences website at View Source

On November 23, 2020 Novellus, Ltd., a clinical-stage biotechnology company focused on precision oncology, and Tempus, a leader in artificial intelligence and precision medicine, reported their collaboration to accelerate patient enrollment for Novellus’ next generation BRAF inhibitor program (Press release, Novellus, NOV 23, 2020, View Source [SID1234571604]).

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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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Novellus’ BRAF program focuses on patient populations for which there are currently no FDA-approved BRAF inhibitors, including BRAF fusions and BRAF-mutated gliomas. Novellus will participate in Tempus’s TIME Trial Network, and the companies will work together to identify relevant patients to accelerate patient enrollment.

"The collaboration with Tempus will enable us to accelerate the enrollment of patients in our BRAF trial, by precisely identifying potential candidates and opening sites wherever the patients are found" said Michael Vidne, Chief Executive Officer of Novellus.

"The TIME Trial Program has achieved an unparalleled scale thus far, with over 50 provider networks and 2,500 oncologists included in its network," said Kim Blackwell, Chief Medical Officer of Tempus. "We’re excited to collaborate with Novellus, to further our mission to increase trial participation, and to ultimately bring the right treatment to the right patients at the right time."

On November 23, 2020 Imago BioSciences, Inc. ("Imago") a clinical-stage biopharmaceutical company developing innovative treatments for myeloproliferative neoplasms, reported its participation in the Piper Sandler 32nd Annual Healthcare Conference to be held virtually December 1 – 3, 2020 (Press release, Imago BioSciences, NOV 23, 2020, View Source [SID1234571601]).

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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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Hugh Young Rienhoff, Jr. M.D., chief executive officer of Imago BioSciences, will participate in a fireside chat with Christopher Andrews. The fireside chat will be pre-recorded and available on the Piper Sandler website to registered attendees beginning on Monday, November 23, 2020 at 10:00 am ET. The Company will host the one-on-one meetings with investors on Monday, November 30, 2020, meetings can be requested exclusively via Piper Sandler.

On November 23, 2020 GT Medical Technologies, Inc., a company dedicated to improving the lives of patients with brain tumors, reported it has raised $16 million in a Series B financing led by MVM Partners with participation from existing investors MedTech Venture Partners and BlueStone Venture Partners (Press release, GT Medical Technologies, NOV 23, 2020, View Source [SID1234571600]). Funds from the round will support the expanded commercialization of GammaTile Therapy, an FDA-cleared, Surgically Targeted Radiation Therapy (STaRT) for patients with brain tumors.

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"Since the FDA clearance of GammaTile Therapy in July 2018 for recurrent brain tumors and our expanded indication including newly-diagnosed malignant brain tumors early this year, many of the country’s leading centers for brain tumor treatment have adopted GammaTile Therapy. Physicians are pleased to finally have a new option for patients with brain tumors after decades of seeking better treatments," said Matthew Likens, President and CEO of GT Medical Technologies. "We are excited that this funding will support our efforts to further expand access to STaRT, allowing even more patients to benefit from this targeted treatment."

Over 700,000 Americans are living with some type of brain tumor today.1 Despite the efforts of the most skilled specialists throughout the world, outcomes for patients with brain tumors have improved very little over the past 30 years. GammaTile Therapy is the latest FDA-cleared treatment for newly diagnosed malignant and recurrent brain tumors, and the company recently announced data showing promising clinical outcomes for patients diagnosed with high-grade gliomas, brain metastases, and aggressive meningiomas.2

GammaTile Therapy first received FDA 510(k) regulatory clearance for the treatment of all types of recurrent brain tumors in July 2018. Earlier this year, GT Medical Technologies received FDA clearance to further expand the indication to allow patients with newly diagnosed malignant brain tumors to receive the therapy.

"Despite advances in care and improvements in outcomes for many other forms of cancer, brain cancer treatment options and outcomes have remained tragically static, with only one-third of patients living beyond five years. GammaTile Therapy provides patients and their clinicians with a needed new treatment modality," said Dr. Kyle Dempsey, Partner at MVM Partners. "Consistent with our investment goals, GammaTile Therapy has the potential to improve outcomes, decrease total healthcare costs, and improve patient satisfaction relative to the current standard of care. We are thrilled to partner with the business and to help ensure more patients and clinicians have access to this innovative technology."

GammaTiles are placed directly at the site of the tumor after surgical excision is complete and immediately targets residual tumor cells before they can replicate and cause tumor recurrence. Designed to protect healthy brain tissue and facilitate rapid, accurate placement during the procedure, the therapy features a bioresorbable, conformable, 3D-collagen tile that emits a sustained and controlled radiation dose.

The company recently announced that the first patient has been enrolled into its registry trial, which will further validate the safety and efficacy of GammaTile Therapy in patients with metastatic brain tumors, gliomas, and meningiomas from up to 50 treatment centers across the United States. Data from the study will be used to benchmark clinical outcomes for GammaTile Therapy and allow for comparisons to existing standard-of-care treatments for patients with brain tumors. In addition to the registry trial, two additional studies evaluating GammaTile Therapy in patients with brain metastases were announced at the 2020 Society of Neuro-Oncology Virtual Meeting on Brain Metastases in August. Those studies, which are led by The University of Texas MD Anderson Cancer Center and Memorial Sloan Kettering Cancer Center, are expected to begin enrollment in Q4 2020.3

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.