On May 6, 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 financial results and business highlights for the second quarter of fiscal 2021 ended March 31, 2021 (Press release, Twist Bioscience, MAY 6, 2021, View Source [SID1234579408]).

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"The second quarter of our fiscal year delivered growth across all four areas of our business, with increasing revenue and very strong orders building momentum for the second half of the year," said Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience. "We signed new biopharma partnerships with multiple associated programs, and we continue to drive increasing density for our data storage vertical.

"For the second half of fiscal 2021 we expect continued growth of our NGS and synbio customer base as we build out the Factory of the Future in Oregon. We intend to advance all programs with our biopharma partners while simultaneously generating data to support out-licensing for our proprietary antibodies. In addition, for data storage, we will continue to pursue innovative engineering and collaborate across the DNA Data Storage Alliance to prepare the market for this novel storage medium."

FISCAL 2021 SECOND QUARTER FINANCIAL RESULTS

Orders: Total orders received for the second quarter of fiscal 2021 were $41.7 million, compared to $24.6 million for the same period of fiscal 2020.
Revenue: Total revenues were $31.2 million for the second quarter of fiscal 2021 compared to $19.3 million for the same period of fiscal 2020.
Cost of Revenues: Cost of revenues for the second quarter of fiscal 2021 was $19.0 million compared to $13.6 million for the same period of fiscal 2020.
Research and Development Expenses: Research and development expenses for the second quarter of fiscal 2021 were $15.8 million compared to $10.6 million for the same period of fiscal 2020.
Selling, General and Administrative Expenses: Selling, general and administrative expenses for the second quarter of fiscal 2021 were $34.4 million compared to $27.2 million for the same period of fiscal 2020.
Net Loss: Net loss for the second quarter of fiscal 2021 was $37.9 million, or $0.78 per share, compared to $31.8 million, or $0.85 per share, for the second quarter of fiscal 2020.
Cash Position: As of March 31, 2021, the company had $555.7 million in cash, cash equivalents and short-term investments.
"We increased our margin to 39%, reflecting the impact of scaling our revenue, leveraging our fixed costs and the benefit of higher NGS product mix," commented Jim Thorburn, CFO of Twist. "Importantly, the solid results demonstrate excellent execution across all teams at Twist."

Fiscal Second Quarter 2021 and Recent Highlights

Shipped products to approximately 1,700 customers in the second quarter of fiscal 2021 versus approximately 1,400 in the same period of fiscal 2020.
Exercised our right of first refusal which gives a cost-effective option to double manufacturing capacity at the "Factory of the Future" just outside of Portland, Oregon
Launched 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. DNA methylation plays a key role in many biological processes including cancer.
Received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA), together with Biotia, for the SARS-CoV-2 Next-Generation Sequencing (NGS) Assay.
Partnered with Watchmaker Genomics to enable innovative research across a wide range of high throughput sequencing applications including tumor profiling, inherited disease detection, liquid biopsy assays and minimal residual disease monitoring.
Added new synthetic RNA controls to develop, validate and verify tests for SARS-CoV-2. The new controls include the B.1.351 (first identified in South Africa) and P.1 (first identified in Brazil) variants of SARS-CoV-2.
Announced three new NGS customers in APAC: Berry Genomics, Victoria Clinical Genetics Services (VCGS) and AcornMed Biotechnology.
Announced three new Twist Biopharma collaborations with Kyowa Kirin, Stanford’s Innovate Medicines Accelerator and Pure Biologics, bringing the total number of partners to 21. Twist Biopharma is now advancing 25 active programs through its partners, 17 of which have milestones and royalties. Additionally, nine programs are now completed.
Published positive preclinical data demonstrating that GLP-1R antibodies identified from Twist Biopharma’s proprietary G-protein coupled receptor (GPCR) libraries showed potent blood glucose control. Glucagon-like peptide-1 receptor (GLP-1R) is a class B GPCR that acts as the receptor for the incretin GLP-1, a peptide released to regulate insulin levels in response to food intake. The data were published online in mAbs.
Exercised our option to purchase all rights to a G-coupled protein receptor (GPCR) library and its proprietary Twist Antibody Optimization software, both developed in collaboration with Distributed Bio.
Named one of Fast Company’s World’s Most Innovative Companies for 2021.
Earned Great Place to Work certification.
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 updated financial guidance:

Increasing revenue guidance in the range of $121 million to $129 million
Revenue from Ginkgo Bioworks expected to be in the range of $11 to $12 million
Synbio revenue excluding Ginkgo Bioworks is expected to be in the range of $43 to $46 million
NGS revenue is estimated to be in the range of $62 to $66 million
Biopharma revenue is estimated to be approximately $5 million
Gross margin is expected to be 36% to 38% for fiscal 2021
Operating expenses including R&D and SG&A are expected to be $192 million for the year
Net loss expected in the range of $144 million to $150 million to reflect our increased investments in our commercial organization and research and development activities
R&D is expected to be approximately $66 million
Stock-based compensation is expected to be approximately $33 million
Depreciation is expected to be $10 million
Capital expenditures are expected to be $40 million, including expansion into "Factory of the Future"
Conference Call Information

The company plans to hold a conference call and live audio webcast for analysts and investors today at 4:30 p.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 4647559. A telephonic replay of the conference call will be available beginning approximately four hours after the call through May 20, 2021 and may be accessed by dialing (855) 859-2056 (domestic) or (404) 537-3406 (international). The replay conference ID is 4647559. 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 May 6, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported that it has been selected as the winner of the "Best New Technology Solution for Oncology" award in the fifth annual MedTech Breakthrough Awards program (Press release, Castle Biosciences, MAY 6, 2021, View Source [SID1234579407]). The award recognizes Castle’s DecisionDx-SCC and DecisionDx DiffDx-Melanoma genomic tests, both newly launched in the second half of 2020.

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Castle Biosciences develops and commercializes diagnostic and prognostic tests for dermatologic cancers. The Company’s tests are designed to provide clinically actionable, tumor-specific genomic information to enable more accurate skin cancer treatment plan decisions. Castle believes that the traditional approach to developing a treatment plan for dermatologic cancers using clinical and pathology factors alone can be improved by incorporating personalized genomic information.

In 2020, Castle launched two new genomic tests designed to improve the management of skin cancer, DecisionDx-SCC and DecisionDx DiffDx-Melanoma. DecisionDx-SCC is the Company’s proprietary gene expression profile (GEP) test that is designed to predict the risk of metastasis for patients with cutaneous squamous cell carcinoma who have one or more risk factors. DecisionDx DiffDx-Melanoma is designed to provide a highly accurate, objective result to aid dermatopathologists and dermatologists in characterizing suspicious pigmented lesions. Castle believes these two recently launched tests complement Castle’s GEP test for invasive cutaneous melanoma, DecisionDx-Melanoma, which is a proprietary GEP test that uses an individual patient’s tumor biology to predict risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity independent of traditional staging factors.

The mission of the MedTech Breakthrough Awards is to honor excellence and recognize the innovation, hard work and success in a range of health and medical technology categories, including Robotics, Clinical Administration, Telehealth, Patient Engagement, Electronic Health Records (EHR), mHealth, Medical Devices, Medical Data and many more. This year’s program attracted more than 3,850 nominations from over 17 different countries throughout the world.

"Skin cancers continue to be the most commonly diagnosed cancers, with around 5.5 million new cases diagnosed annually in the U.S., and Castle is addressing this challenge head-on," said James Johnson, managing director, MedTech Breakthrough. "When individualized genomic information is incorporated with traditional clinical and pathology factors used to assess risk, physicians and patients can make more informed treatment decisions, in line with each patient’s risk. Castle is driving innovation in this space, and we are thrilled to recognize Castle in our 2021 MedTech Breakthrough Awards program."

"The approach that physicians traditionally use to determine risk–reviewing clinical and pathological factors like patient history and pathology lab results— is necessary and lifesaving. But adding personalized, precise genomic information to predict the likelihood of any individual’s skin cancer’s future spread or return, or for aiding clinicians with difficult-to-diagnose potential melanoma cases, has the potential to improve patient care," said Derek Maetzold, president and chief executive officer at Castle Biosciences. "We developed DecisionDx-SCC and DecisionDx DiffDx-Melanoma to answer this significant unmet medical need in skin cancer management, and we are thrilled to receive this 2021 MedTech Breakthrough Award in recognition of our innovation in this breakthrough approach and technology to support it."

On May 6, 2021 Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, reported financial results for the quarter ended March 31, 2021, and provided an update on recent accomplishments and upcoming events (Press release, Syros Pharmaceuticals, MAY 6, 2021, View Source [SID1234579406]).

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"We continue to make substantial progress toward our vision of building Syros into a fully integrated company, with leading portfolios in targeted hematology and selective CDK inhibition and a robust gene control discovery engine," said Nancy Simonian, M.D., Chief Executive Officer of Syros. "We began enrolling patients in our Phase 3 clinical trial of SY-1425 in RARA-positive higher-risk MDS, marking the start of our first registration-enabling trial and an important step toward our goal of setting new standards of care in the treatment of hematologic malignancies. Looking ahead, we are poised to continue building on this momentum. We look forward to initiating additional clinical trials with SY-1425 and SY-2101 in the second half of the year and reporting new dose-escalation data, including clinical activity, from our Phase 1 trial of SY-5609 in the third quarter, while continuing to invest in our earlier-stage programs in cancer and monogenic diseases."

Syros reported plans to host a three-part KOL webinar series focused on its portfolio of investigational targeted hematology therapies. This series will consist of presentations from key opinion leaders and clinical collaborators who will review the unmet need and evolving landscapes in higher-risk myelodysplastic syndrome (HR-MDS), newly diagnosed unfit acute myeloid leukemia (AML), and acute promyelocytic leukemia (APL), as well as Syros leaders who will review recent progress for SY-1425 and for SY-2101 in these diseases. Each event will be webcast live on the Investors & Media section of Syros’ website, www.syros.com. More details for the series are forthcoming.

Upcoming Milestones
SY-1425: Oral RARa agonist

Initiate randomized Phase 2 trial of SY-1425 in combination with venetoclax and azacitidine in the second half of 2021 in RARA-positive newly diagnosed AML patients who are not suitable candidates for standard intensive chemotherapy.
Report initial data from the randomized Phase 2 trial in 2022.
SY-2101: Oral arsenic trioxide (ATO)

Initiate dose-confirmation study of SY-2101 in the second half of 2021.
Report confirmatory dose and pharmacokinetic data in first half of 2022.
Initiate Phase 3 trial in patients with newly diagnosed APL in 2022.
SY-5609: Oral CDK7 inhibitor

Report additional dose-escalation data, including clinical activity data, in the third quarter of 2021 from the ongoing Phase 1 trial of SY-5609 in patients with breast, colorectal, lung, ovarian and pancreatic cancers, as well as in patients with solid tumors of any histology harboring Rb pathway alterations.
Initiate expansion portion of Phase 1 trial in the second half of 2021.
Gene control discovery engine

Nominate next development candidate in 2022.
Recent Pipeline Highlights

Syros began dosing patients in its Phase 3 trial evaluating SY-1425 in combination with azacitidine in RARA-positive patients with newly diagnosed HR-MDS. The double-blind, placebo-controlled trial is expected to enroll approximately 190 patients. Patients will be randomized 2:1 to receive SY-1425 in combination with azacitidine or placebo, respectively. The primary endpoint of the trial is complete response (CR) rate.
Recent Corporate Highlights

In January 2021, Syros completed an underwritten public offering of 5,400,000 shares of common stock, at a public offering price of $14.00 per share, resulting in gross proceeds of approximately $75.6 million, before underwriting discounts and commissions.
First Quarter 2021 Financial Results

Revenues were $4.8 million for the first quarter of 2021, consisting of $4.0 million in revenue recognized under Syros’ collaboration with Global Blood Therapeutics, Inc. (GBT) and $0.8 million recognized under its collaboration with Incyte Corporation (Incyte). Syros recognized $2.4 million in revenue in the first quarter of 2020, including $2.2 million under its collaboration with GBT and $0.2 million under its collaboration with Incyte.
Research and development expenses were $20.0 million for the first quarter of 2021, as compared to $14.6 million for the first quarter of 2020. This increase was primarily attributable to the continued advancement of Syros’ clinical programs, including the addition of SY-2101, and an increase in employee-related expenses.
General and administrative (G&A) expenses were $5.7 million for the first quarter of 2021, as compared to $5.1 million for the first quarter of 2020. This increase was primarily attributable to an increase in employee-related expenses.
For the first quarter of 2021, Syros reported a net loss of $14.2 million, or $0.23 per share, compared to a net loss of $17.2 million, or $0.39 per share, for the same period in 2020.
Cash and Financial Guidance
Cash, cash equivalents and marketable securities as of March 31, 2021 were $222.1 million, as compared with $174.0M million on December 31, 2020. This increase reflects the gross proceeds of $75.6 million that Syros received from its January 2021 public offering, partially offset by cash used to fund its operations.

Based on its current plans, Syros believes that its existing cash, cash equivalents and marketable securities will be sufficient to fund its planned operating expenses and capital expenditure requirements into 2023.

Conference Call and Webcast
Syros will host a conference call today at 8:30 a.m. ET to discuss these first quarter 2021 financial results and provide a corporate update.

To access the live conference call, please dial 866-595-4538 (domestic) or 636-812-6496 (international), and refer to conference ID 5770919. A webcast of the call will also be available on the Investors & Media section of the Syros website at www.syros.com. An archived replay of the webcast will be available for approximately 30 days following the presentation.

On May 6, 2021 Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, reported its financial results for the first quarter of 2021 and provided a corporate update (Press release, Gossamer Bio, MAY 6, 2021, View Source [SID1234579405]).

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Clinical-Stage Product Candidate Updates

Seralutinib (GB002): Inhaled PDGFR, CSF1R and C-KIT Inhibitor for PAH

Enrollment ongoing in the TORREY Study, a Phase 2 clinical trial in patients with PAH whose disease has progressed despite standard-of-care therapy. The primary endpoint is change in pulmonary vascular resistance (PVR) from baseline at week 24. Topline data from the TORREY study are expected in the first half of 2022, subject to developments in the ongoing COVID-19 pandemic.
Key opinion leader-led webcast and presentation regarding PAH and seralutinib held on December 15, 2020 available through the "Events / Presentations" page in the "Investors" section of the Company’s website at www.gossamerbio.com.
GB004: Oral, Gut-Targeted HIF-1α Stabilizer for Inflammatory Bowel Disease (IBD)

Enrollment ongoing in the SHIFT-UC Study, a Phase 2 clinical trial in patients with active UC despite treatment with 5-ASAs. The primary endpoint is proportion of patients with clinical remission at week 12. Topline data from the SHIFT-UC study are expected in the first half of 2022, subject to developments in the ongoing COVID-19 pandemic.
Key opinion leader-led webcast and presentation regarding IBD and GB004 held on February 18, 2021 available through the "Events / Presentations" page in the "Investors" section of the Company’s website at www.gossamerbio.com.
GB1275: Oral CD11b Modulator for Solid Tumor Oncology Indications

Enrollment ongoing in a Phase 1 expansion cohort studying the recommended Phase 2 dose in KEYNOTE-A36, a Phase 1/2 clinical trial, including patients with gastric or esophageal cancer who have progressed after initial response to anti-PD-1 therapy and patients with advanced MSS colorectal cancer.
Additional clinical data from the ongoing GB1275 Phase 1/2 will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 Annual Meeting being held virtually from June 4 – 8, 2021. Oral presentation details:
Abstract Number: 2505
Abstract Title: Preliminary clinical and biologic results of GB1275, a first-in-class oral CD11b modulator, alone and with pembrolizumab, in advanced solid tumors (KEYNOTE-A36)
Session Title: Developmental Therapeutics – Immunotherapy
Session Date and Time: Monday, June 7, 2021 from 3:00 pm – 6:00 pm ET
Corporate Updates

Gossamer announced the promotion of Laura Carter, Ph.D. and Caryn Peterson to Chief Scientific Officer and Executive Vice President, Regulatory Affairs, respectively.
Financial Results for the Quarter Ended March 31, 2021

Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of March 31, 2021, were $453.3 million. The Company expects the combination of current cash, cash equivalents and marketable securities, and access to its debt facility will be sufficient to fund its operating and capital expenditures into the second half of 2023.
Research and Development (R&D) Expenses: For the quarter ended March 31, 2021, R&D expenses were $41.8 million, compared to R&D expenses of $41.4 million for the same period in 2020.
General and Administrative (G&A) Expenses: For the quarter ended March 31, 2021, G&A expenses were $11.3 million, compared to $10.7 million for the same period in 2020.
Net Loss: Net loss for the quarter ended March 31, 2021, was $57.6 million, or $0.78 per share, compared to a net loss of $54.1 million, or $0.87 per share, for the same period in 2020.

On May 6, 2021 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 the Company’s CEO Dr. Pnina Fishman will present at Benzinga’s Global SmallCap Conference on Thursday, May 13, 2021 at 11:10 a.m. ET on the Transformative Healthcare track (Press release, Can-Fite BioPharma, MAY 6, 2021, View Source [SID1234579404]). Investors interested in viewing Can-Fite’s presentation may register with free access for the two-day conference which takes place virtually on May 13 and 14, 2021 here: View Source

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Dr. Fishman will give an overview of Can-Fite’s psoriasis, liver cancer and NASH study results which together demonstrate a clinical proof of concept for its platform technology with drug candidates in Phase II and Phase III. An update on the Company’s cannabis work will be presented as well.