On March 1, 2021 RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, reported that it has entered into an underwriting agreement with H.C. Wainwright & Co., LLC under which the underwriter has agreed to purchase on a firm commitment basis 1,250,000 American Depositary Shares (ADSs) of the Company, at a price to the public of $8.00 per ADS, less underwriting discounts and commissions (Press release, RedHill Biopharma, MAR 1, 2021, View Source [SID1234575876]). Each ADS represents ten ordinary shares, par value NIS 0.01 per share, of the Company. The closing of the offering is expected to occur on or about March 4, 2021, subject to satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

The Company also has granted to the underwriter a 30-day option to purchase up to additional 187,500 ADSs at the public offering price, less underwriting discounts and commissions.

The gross proceeds to RedHill, before deducting underwriting discounts and commissions and offering expenses and assuming no exercise of the underwriter’s option to purchase additional ADSs, are expected to be $10 million. The Company intends to use the net proceeds from this offering to fund its clinical development programs, commercialization activities and for acquisitions and general corporate purposes.

The securities described above are being offered by RedHill pursuant to a "shelf" registration statement on Form F-3 (File No. 333-232777) previously filed with the Securities and Exchange Commission (the "SEC") on July 24, 2019 and declared effective by the SEC on August 8, 2019. The offering of the securities is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the securities being offered will be filed with the SEC. Electronic copies of the preliminary prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On March 1, 2021 NanoString Technologies, Inc. (NASDAQ:NSTG), a leading provider of life science tools for discovery and translational research, reported financial results for the fourth quarter and year ended December 31, 2020 (Press release, NanoString Technologies, MAR 1, 2021, View Source [SID1234575872]).

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Fourth Quarter Financial Highlights

Product and service revenue of $35.7 million, 6% year-over-year growth. On a pro forma basis, reflecting the impact of the Veracyte transaction on revenue recorded for Prosigna IVD kits, product and service revenue increased by 9%
Instrument revenue of $15.3 million, 11% year-over-year growth. Instrument revenue includes $9.3 million of GeoMx Digital Spatial Profiler (DSP) instrument revenue
Consumables revenue of $16.6 million, 2% year-over-year decline. On a pro forma basis, reflecting the impact of the Veracyte transaction, consumables revenue increased by 3%. Consumables revenue includes $2.8 million of GeoMx DSP consumables revenue
Service revenue of $3.8 million, 29% year-over-year growth
Full Year 2020 Financial Highlights

Product and service revenue of $111.4 million, 7% year-over-year growth. Pro forma growth was 14%
Instrument revenue of $47.8 million, 54% year-over-year growth. Instrument revenue includes $29.6 million of GeoMx DSP instrument revenue
Consumables revenue of $50.1 million, 18% year-over-year decline. On a pro forma basis, consumables revenue decreased 10%. Consumables revenue includes $5.3 million of GeoMx DSP consumables revenue
Service revenue of $13.5 million, 16% year-over-year growth
Cash, cash equivalents and short-term investments balance of $440.7 million
"During 2020, we successfully achieved all of our strategic objectives against the challenging operating backdrop of the COVID-19 pandemic. We extended our leadership in spatial biology, growing GeoMx DSP instrument orders by 50% and opening up a large market opportunity in basic discovery through the introduction of the first next generation sequencing panels for GeoMx," said Brad Gray, president and CEO of NanoString. "We look forward to continuing our momentum in 2021, with key catalysts including the commercial launch of our GeoMx Whole Transcriptome Atlas and a Technology Access Program service for our recently unveiled Spatial Molecular Imager."

Recent Business Highlights

Nature Methods 2020 "Method of the Year": Leading scientific journal Nature Methods announced that spatially resolved transcriptomics was selected as their 2020 "Method of the Year"
Spatial Genomics Summit: Held third annual Spatial Genomics Summit on February 23rd, focused on scientific advancements and new technology in the spatial genomics market. Panelists included leading researchers from Bristol-Myers Squibb, Harvard Medical School, Wellcome Sanger Trust and the Fred Hutchinson Cancer Research Center
Advances in Genome Biology and Technology (AGBT) Conference: Hosted Gold Sponsorship Workshop focused on "Progressing Spatial Biology from Tissue Architecture to Sub-cellular Functions." AGBT included more than 20 posters and presentations on spatial biology using GeoMx DSP and our Spatial Molecular Imager
GeoMx DSP

GeoMx Shipments and Installations: Shipped approximately 40 and installed approximately 30 GeoMx DSP instruments in the fourth quarter, bringing cumulative shipments to more than 160 and cumulative installs to approximately 130 instruments since launch
Launch of Whole Transcriptome Atlas: Announced the commercial availability of the GeoMx Whole Transcriptome Atlas, which provides expanded access to next generation sequencing (NGS) readout on GeoMx DSP
Continued Growth of GeoMx Technology Access Program (TAP): Generated a record of 87 new GeoMx TAP project orders in the fourth quarter, of which more than 40% used our Whole Transcriptome Atlas with NGS readout. As of December 31, 2020, we have conducted over 430 TAP projects for approximately 200 customers
Publications: Continued growth of peer-reviewed publications utilizing GeoMx DSP technology, with 6 new publications in the fourth quarter, bringing the cumulative total to 35 peer-reviewed publications as of December 31, 2020
Spatial Molecular Imager

Unveiled Spatial Molecular Imaging Platform: Announced the development of the Spatial Molecular Imager, a new spatial biology platform capable of measuring the expression of 1,000+ genes at single-cell and sub-cellular resolution
Launch of Spatial Molecular Imager under TAP: Announced a new SMI TAP service offering, providing the opportunity for customers to access the capabilities of SMI in 2021 by sending their biological samples to our Seattle, WA facility to be analyzed
nCounter

nCounter Installed Base: Grew installed base to approximately 950 nCounter Analysis Systems at December 31, 2020, representing 13% growth over the prior year
Publications: Surpassed 4,000 cumulative peer-reviewed publications utilizing nCounter technology, representing continued research momentum for the nCounter platform
Fourth Quarter Financial Results

We have elected to present selected non-GAAP, or adjusted, financial measures, including Adjusted EBITDA. These adjusted financial measures are calculated excluding certain items that may make it more challenging to compare our GAAP operating results across periods. Such items may include collaboration revenue, stock-based compensation, depreciation and amortization, or one-time charges such as transaction related fees and expenses or restructuring charges and severance costs. A reconciliation of adjusted financial measures to the nearest comparable GAAP financial measure can be found in the notes and table at the end of this press release.

2021 Outlook

The company, based on its plans and initiatives for 2021, expects to record results approximately as follows:

Total product and service revenue of $140 to $150 million, representing growth of 26% to 35% as compared to 2020
GeoMx DSP revenue of $45 to $50 million
nCounter revenue, inclusive of all service revenue, of $95 to $100 million
Adjusted gross margin on product and service revenue of 55% to 57%
Adjusted operating expenses of $145 to $155 million
Adjusted EBITDA loss of $65 to $70 million
Supplemental Information

As a supplement to the table above, we have posted to the investor relations section of our website, at www.nanostring.com, supplemental financial data that includes our adjusted financial measures as compared to the nearest comparable GAAP financial measures, for the fourth quarter and the full year of 2020 and for each quarter and the full year of 2019.

Conference Call

Management will host a conference call today beginning at 1:30 pm PT / 4:30 pm ET to discuss these results and answer questions. Investors and other interested parties can register for the call in advance by visiting View Source After registering, an email confirmation will be sent, including dial-in details and unique conference call codes for entry. Registration is open throughout the call but to ensure connection for the full call, registration in advance is recommended. The link to the webcast and audio replay will be made available at the Investor Relations website: www.nanostring.com. A replay of the call will be available beginning March 1, 2021 at 7:30pm ET through midnight ET on March 8, 2021. To access the replay, dial (800) 585-8367 or (416) 621-4642 and reference Conference ID: 3093307. The webcast will also be available on our website for one year following the completion of the call.

Non-GAAP, or Adjusted, Financial Information

We believe that the presentation of non-GAAP, or adjusted, financial information provides important supplemental information to management and investors regarding financial and business trends relating to our financial condition and results of operations. Reconciliation of adjusted financial measures to the most directly comparable financial result as determined in accordance with GAAP are included at the end of this press release following the accompanying financial data. A reconciliation of adjusted guidance measures to corresponding GAAP measures is not available on a forward-looking basis without unreasonable effort due to the uncertainty regarding certain expenses that may be incurred in the future. For further information regarding why we believe that these adjusted measures provide useful information to investors, the specific manner in which management uses these measures and some of the limitations associated with the use of these measures, please refer to "Notes Regarding Non-GAAP Financial Information" at the end of this press release.

Pro Forma Financial Information

As used in this press release, "pro forma" percentages are calculated by comparing the applicable period-over-period financial results to reflect the impact of the Veracyte transaction as if such transaction had occurred on January 1, 2019, the beginning of the earliest period presented. Further disclosure regarding the terms and pro forma impact of the Veracyte transaction can be obtained in our Current Report on Form 8-K filed with the Securities and Exchange Commission on December 4, 2019.

On March 1, 2021 AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, reported that Jim Clemmer, President and Chief Executive Officer, and Stephen Trowbridge, Executive Vice President and Chief Financial Officer, will present at the Barclays Virtual Global Healthcare Conference at 8:00 a.m. ET on Tuesday, March 9, 2021 (Press release, AngioDynamics, MAR 1, 2021, View Source [SID1234575871]).

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A live webcast of the presentation will be accessible through the "Investors" section of the Company’s website at www.angiodynamics.com and will be available for replay following the event.

On March 1, 2021 Lantheus Holdings, Inc. (NASDAQ: LNTH) (Lantheus), an established leader and fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to Find, Fight and Follow serious medical conditions, reported the publication of the results of both pivotal studies for PyL, an investigational PET imaging agent that targets prostate-specific membrane antigen (PSMA) (Press release, Lantheus Medical Imaging, MAR 1, 2021, View Source [SID1234575870]). The OSPREY Phase 2/3 trial results have been published online in the Journal of Urology and the CONDOR Phase 3 trial results have been published in the online version of Clinical Cancer Research.

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"The limitations of conventional imaging modalities for prostate cancer create a need for targeted imaging in the initial assessment of high-risk patients as well as in men with early biochemically relapsed disease," said Michael J. Morris, M.D., Prostate Cancer Section Head, Genitourinary Medical Oncology Service, Division of Solid Tumor Oncology, Memorial Sloan Kettering Cancer Center, and lead author of the CONDOR manuscript and senior author on the OSPREY manuscript. "The OSPREY trial data highlighted the high positive predictive value, negative predictive value and specificity of PyL in staging high-risk patients. The CONDOR trial demonstrates its high positive predictive value to accurately locate and identify recurrent cancer early and non-invasively. Assuming FDA approval, physicians will be able to use this clinically meaningful information to identify disease, guide treatment plans, and improve disease management."

Mary Anne Heino, President and Chief Executive Officer of Lantheus added, "We believe these data demonstrate PyL’s clinical benefit and are honored to have our studies published in such well-respected peer-reviewed journals. The results of the OSPREY and CONDOR trials are part of our NDA that is currently under priority review at the FDA for marketing authorization in the United States. We believe PyL has the potential to play an important role in transforming the management of men with high-risk, recurrent or metastatic prostate cancer."

Kenneth J. Pienta, M.D., Director of Research at the James Buchanan Brady Urological Institute and Professor of Urology at Johns Hopkins University School of Medicine, was the lead author of the OSPREY manuscript. The OSPREY publication in the Journal of Urology may be found online here.

Michael J. Morris, M.D., Prostate Cancer Section Head of the Genitourinary Medical Oncology Service and Division of Solid Tumor Oncology at Memorial Sloan Kettering Cancer Center. Was the lead author of the CONDOR manuscript. The CONDOR publication in Clinical Cancer Research may be found online here.

OSPREY Phase 2/3 Trial
The OSPREY trial was designed to assess the diagnostic performance of PyL to detect prostate cancer in pelvic lymph nodes in subjects with high-risk prostate cancer (Cohort A) and confirm distant metastases in subjects with metastatic or recurrent prostate cancer (Cohort B). The primary endpoints for the trial were sensitivity and specificity of PyL PET/CT imaging to detect metastatic prostate cancer within the pelvic lymph nodes relative to histopathology in Cohort A. A key secondary endpoint of the trial was the sensitivity of PyL PET/CT imaging to detect prostate cancer within sites of metastasis or local recurrence relative to histopathology in Cohort B.

In the trial, the diagnostic performance of PyL in detecting disease in pelvic lymph nodes (Cohort A) was compared with histopathology. PyL showed specificity of 96-99%, sensitivity of 31-42%, and PPV of 78-91% meeting the specificity but not the pre-established sensitivity co-primary endpoint. In the metastatic or recurrent prostate cancer setting (Cohort B), PyL exhibited sensitivity of 93-99% and PPV of 81-88% in detecting metastatic lesions. Overall, PyL demonstrated high diagnostic performance in reliably detecting nodal and distant metastatic prostate cancer.

Safety results showed PyL was well tolerated. The most frequent adverse events reported were dysgeusia (2.6%), headache (1.8%), and fatigue (1.3%).

CONDOR Phase 3 Trial
The CONDOR trial was designed to assess the diagnostic performance and clinical utility of PyL in men with biochemically recurrent prostate cancer and uninformative standard imaging. The primary endpoint in the trial was the Correct Localization Rate (CLR) of PyL. CLR is based on positive predictive value, defined as the percentage of patients with a one-to-one correspondence between localization of at least one lesion identified on PyL PET/CT and a composite truth standard. The composite truth is comprised of, in descending priority, histopathology, subsequent correlative imaging findings, or PSA response following radiation therapy. The key secondary endpoint in the trial was the percent of subjects with a change in intended prostate cancer treatment due to PyL imaging results.

The CONDOR trial achieved its primary endpoint, with a CLR of 84.8% to 87.0% among the three blinded independent readers (the lower bound of the 95% confidence intervals ranging from 77.8% to 80.4%). In the key secondary endpoint, 63.9% of patients had a change in intended prostate cancer treatment following review of PyL imaging results. The most frequent changes in intended prostate cancer treatment plans included changing salvage local therapy to systemic therapy, observation to initiating therapy, noncurative systemic therapy to salvage curative local therapy and planned treatment to observation.

Safety results showed PyL was well tolerated. The most frequent adverse event reported was headache, which was reported in four patients (1.9% of the trial population). There was one serious adverse event of hypersensitivity reported as related to the study drug.

About Prostate Cancer
Prostate cancer is the second most common form of cancer affecting men in the United States — an estimated one in eight men will be diagnosed with prostate cancer in their lifetimes. The American Cancer Society estimates that in 2021, 248,530 new cases of prostate cancer will be diagnosed, and 34,130 men will die of the disease. Approximately 3.1 million men in the United States currently count themselves as prostate cancer survivors.1

About PyL
PyL (also known as 18F-DCFPyL) is an investigational fluorinated PSMA-targeted PET imaging agent that enables visualization of localized prostate cancer both localized as well as metastatic to lymph nodes, bone and soft tissue to detect and localize recurrent and/or metastatic prostate cancer. On September 29, 2020, Lantheus submitted a new drug application (NDA) for PyL which was accepted and granted priority review and assigned a Prescription Drug User Fee Act (PDUFA) action date of May 28, 2021.

On March 1, 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 several events at the virtual 2021 Advances in Genome Biology and Technology (AGBT) meeting to be held March 1-3, 2021 (Press release, Twist Bioscience, MAR 1, 2021, View Source [SID1234575869]).

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During the conference, Twist will host a workshop with customer presentations from Regeneron Genetics Center and HelioHealth; Twist will present a poster detailing the ongoing development of its Artificial Barcoded Libraries; and, will have a virtual booth. The events are listed below:

Date: March 1, 2:45pm – 3:10pm EST

"Believe in Better – an update from Twist" — Emily Leproust, Ph.D., CEO and co-founder of Twist Bioscience

"No more arrays: genotyping by sequencing enables economical and improved association studies" — Gonçalo Abecasis, D.Phil, Vice President, Chief Genomics and Data Sciences Officer at the Regeneron Genetics Center

"NGS Methylation in Cancer Detection" — Kenneth Chahine, Ph.D., J.D., CEO, HelioHealth

Date: Tuesday, March 2, 3:30pm-5:30pm EST

Poster Session

Abstract: Increasing the throughput of NGS sequencing through rational design and empirical validation of 10,000 Unique Dual Indexes (UDI). To assess the performance of individual barcodes to increase the throughput of NGS sequencing, Twist developed Artificial Barcoded Libraries (ABLs), a high throughput NGS library generation method that utilizes fragmentation of a human genomic source and automation to generate thousands of unique NGS libraries with minimal bias. The approach yielded more than 10,000 pairs of 12bp UDI primers. Performance criteria for uniform UDI primer sets with thousands of members that are suitable for high multiplex hybridization applications and investigations are presented.

Presenter: Richard Gantt, Twist Bioscience