On March 1, 2022 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, 2021 (Press release, NanoString Technologies, MAR 1, 2022, View Source [SID1234609335]).

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Fourth Quarter Financial Highlights
•Product and service revenue of $42.0 million, 18% year-over-year growth
•GeoMx Digital Spatial Profiler (DSP) revenue of $18.0 million, 48% year-over-year growth. GeoMx DSP revenue includes:
◦Instrument revenue of $11.9 million, 27% year-over-year growth
◦Consumables revenue of $6.1 million, 117% year-over-year growth, annualized pull-through of approximately $109,000 per installed system
•nCounter revenue, inclusive of all service revenue, of $24.0 million, 2% year-over-year growth. nCounter revenue includes:
◦Instrument revenue of $5.7 million, 5% year-over-year decline
◦Consumables revenue of $13.8 million, flat year-over-year, annualized pull-through of approximately $53,000 per installed system
◦Service revenue of $4.6 million, 20% year-over-year growth
Full Year 2021 Financial Highlights
•Product and service revenue of $144.0 million, 29% year-over-year growth
•GeoMx DSP revenue of $51.9 million, 49% year-over-year growth. GeoMx DSP revenue includes:
◦Instrument revenue of $34.8 million, 17% year-over-year growth
◦Consumables revenue of $17.1 million, 226% year-over-year growth, average annualized pull-through of approximately $97,000 per installed system
•nCounter revenue, inclusive of all service revenue, of $92.1 million, 20% year-over-year growth. nCounter revenue includes:
◦Instrument revenue of $20.8 million, 14% year-over-year growth
◦Consumables revenue of $54.8 million, 22% year-over-year growth, average annualized pull-through of approximately $55,000 per installed system
◦Service revenue of $16.5 million, 22% year-over-year growth
•Cash, cash equivalents and short-term investments balance of $348.9 million
"We delivered a strong finish to 2021, generating more than 70 Q4 instrument orders across GeoMx and CosMx. This demonstrates the appeal of our unique spatial biology portfolio, which addresses scientific questions at any scale," said Brad Gray, President and CEO of NanoString. "During 2022, we plan to extend our leadership in spatial biology by driving GeoMx into mainstream research, launching CosMx as the market-leading spatial molecular imager, and integrating both with a cloud-based informatics portal, all while sustaining the growth of our nCounter platform."
Operational Highlights
Spatial Biology
•Spatial Genomics Summit: Held fourth annual Spatial Genomics Summit on February 28th, focused on scientific advancements and new technology in the spatial genomics market. Panelists included leading researchers from Mayo Clinic, Massachusetts General Hospital, New York University, Weill Cornell Medical Center, Boston University School of Medicine, Oregon Health and Science University and Illumina
GeoMx DSP
•GeoMx Orders: Generated record orders for more than 50 GeoMx DSP systems in the fourth quarter, representing approximately 80% growth as compared to the fourth quarter of 2020
•GeoMx Installed Base: Grew installed base to approximately 255 GeoMx DSP Systems at December 31, 2021, representing 96% growth over the prior year
•Workflow Automation: Partnered with Leica, a division of Danaher, to provide a fully automated workflow for using the Leica Bond RX system to prepare slides for GeoMx DSP
•Publications: Continued growth of peer-reviewed publications utilizing GeoMx DSP technology, with approximately 20 new publications in the fourth quarter, bringing the cumulative total to approximately 90 peer-reviewed publications as of December 31, 2021
CosMx SMI
•CosMx Orders: Secured customer orders for 20 CosMx Spatial Molecular Imager (SMI) systems through a limited program open to existing and new GeoMx customers
•Commercial Unveiling: Announced the initiation of a formal pre-order program for CosMx SMI with first shipments expected in late 2022
nCounter
•nCounter Installed Base: Grew installed base to approximately 1,050 nCounter Analysis Systems at December 31, 2021, representing 11% growth over the prior year
•Publications: Surpassed 5,200 cumulative peer-reviewed publications utilizing nCounter technology, representing an increase of more than one thousand publications over the last year, demonstrating continued research momentum for the nCounter platform
2022 Outlook
The company, based on its plans and initiatives for 2022, expects to record results approximately as follows:
•Total product and service revenue of $170 to $180 million, representing growth of 18% to 25% as compared to 2021
◦GeoMx DSP revenue of $73 to $78 million, representing growth of 41% to 50% as compared to 2021
◦nCounter revenue, inclusive of all service revenue, of $97 to $102 million, representing growth of 5% to 11% as compared to 2021
•Adjusted gross margin on product and service revenue of 56% to 58%
•Adjusted operating expenses of $155 to $165 million
•Adjusted EBITDA loss of $55 to $65 million
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.
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 include our adjusted financial measures as compared to the nearest comparable GAAP financial measures, for the fourth quarter and the full year of 2021 and for each quarter and the full year of 2020.
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, 2022 at 7:30pm ET through midnight ET on March 10, 2022. To access the replay, dial (866) 813-9403 or (929) 458-6194 and reference Conference ID: 709416. 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.

On March 1, 2022 Corcept Therapeutics Incorporated (NASDAQ: CORT) reported it will host an event for investors and analysts on Thursday, March 31, 2022 regarding its ovarian cancer program (Press release, Corcept Therapeutics, MAR 1, 2022, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-host-ovarian-cancer-program-update-thursday [SID1234609333]). Corcept will present results from the company’s 178-patient, randomized, controlled, Phase 2 study of relacorilant plus nab-paclitaxel for treatment of patients with advanced, platinum-resistant ovarian cancer.

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Topic Corcept’s ovarian cancer program: relacorilant + nab-paclitaxel
Featured Speaker Dr. Thomas Herzog
Professor and Deputy Director at the University of Cincinnati Cancer Center
Board of Directors of Gynecologic Oncology Group (GOG) Partners
Date Thursday, March 31, 2022, 9:00am EST – 10:30am EST
Logistics To access and register for the live webcast, please click here to register
About Corcept’s Oncology Programs

There is substantial in vitro, in vivo and clinical evidence that cortisol’s activity allows certain solid tumors to resist treatment. In some cancers, cortisol inhibits cellular apoptosis – the tumor-killing effect many treatments are meant to stimulate. In other cancers, cortisol activity promotes tumor growth. Cortisol also suppresses the body’s immune response; activating – not suppressing – the immune system is beneficial in fighting certain cancers.

Modulating cortisol’s activity may help existing anti-cancer treatments achieve their intended effect. Many types of solid tumors express the glucocorticoid receptor ("GR") and are potential targets for cortisol modulation therapy. Corcept is conducting clinical trials of its proprietary selective cortisol modulators in combination with three different anti-cancer treatments in patients with ovarian, adrenal and prostate cancers. Corcept’s first controlled study in oncology – relacorilant plus nab-paclitaxel for the treatment of patients with ovarian cancer – has demonstrated statistically significant and clinically meaningful results.

About Corcept’s Ovarian Cancer Program

Corcept is completing a 178-patient, randomized, controlled, Phase 2 trial of relacorilant plus nab-paclitaxel in patients with recurrent platinum-resistant ovarian cancer. Women who entered the trial had experienced disease progression on prior-lines of therapy. The median number of prior treatments was three.

Study participants were randomized 1:1:1 to receive either (i) nab-paclitaxel plus 150 mg of relacorilant given the day before, the day of, and the day after each weekly nab-paclitaxel infusion ("Intermittent" arm), (ii) nab-paclitaxel plus 100 mg relacorilant given daily ("Continuous" arm), or (iii) nab-paclitaxel alone ("Comparator" arm). While women in both relacorilant treatment arms experienced an improvement in progression free survival relative to the Comparator arm, the improvement in the higher dose Intermittent arm was statistically significant (median PFS: 5.6 months versus 3.8 months, hazard ratio: 0.66; p-value: <0.05). The women in the Intermittent arm also experienced a statistically significant improvement in the duration of response (DoR) relative to those in the Comparator arm (median DoR: 5.6 months versus 3.7 months, hazard ratio: 0.36; p-value: 0.006).

While the overall survival (OS) data was only 63% mature at the time of the database cut-off (March 2021), the women in the Intermittent arm exhibited a median OS of 12.9 months versus 10.4 months in the Comparator arm. Safety and tolerability of relacorilant plus nab-paclitaxel was comparable to nab-paclitaxel monotherapy.

Corcept plans to start a Phase 3 trial in second quarter 2022.

Preliminary results from this trial were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021. The ESMO (Free ESMO Whitepaper) presentation is available at www.corcept.com/research-pipeline/publications. Additional information about the study (NCT03776812) can be obtained at www.ClinicalTrials.gov.

About Relacorilant

Relacorilant is a non-steroidal, selective modulator of the glucocorticoid receptor that does not bind to the body’s other hormone receptors. Corcept is studying relacorilant in a variety of serious disorders, including ovarian, adrenal and prostate cancer and Cushing’s syndrome. Relacorilant is proprietary to Corcept and is protected by composition of matter and method of use patents. It has received orphan drug designation in the United States for the treatment of Cushing’s syndrome and pancreatic cancer.

On March 1, 2022 Veracyte, Inc. (Nasdaq: VCYT) reported that Marc Stapley, chief executive officer, and Rebecca Chambers, chief financial officer, will participate in a presentation at Cowen’s 42nd Annual Health Care Conference on March 8th at 12:50 p.m. Eastern Time (Press release, Veracyte, MAR 1, 2022, View Source [SID1234609323]).

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A live audio webcast of the company’s presentation will be available on Veracyte’s website at View Source A replay of the webcast will be available for 90 days following the conclusion of the live presentation broadcast.

On March 1, 2022 Pascal Biosciences Inc. ("Pascal" or the "Company") (TSXV:PAS) (OTC:PSCBF) (FSE: 6PB-FF), reported the appointment of Dr. Brian Bapty as Chief Executive Officer and President, for a five year term which can be renewed. Dr. Bapty will also serve on the Board of Directors (Press release, Pascal Biosciences, MAR 1, 2022, View Source [SID1234609322]). Dr. Bapty has an extensive background in the biotechnology industry and has been active in the capital markets for over 20 years. He received his Ph.D. in Research Medicine from the University of British Columbia in 1999 and then for eight years was at Raymond James Ltd. as their Biotechnology and Healthcare Equities Analyst. He has served as an independent strategic advisor to the industry, Director of Business Development at Helius Medical Technologies, a partner in a private equity firm, and CEO and Healthcare Investment Banker in a boutique brokerage firm. As a scientist, with an extensive business background, Dr. Bapty brings a unique skill set and fresh perspective to Pascal.

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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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"Brian has great energy and the expertise to accelerate Pascal’s drive to the clinic," said Dr. Patrick Gray, Chairman of the Board of Directors. "In addition to his strong scientific background, he understands capital markets and how to finance and move biotech companies forward."

Dr. Bapty stated, "In Pascal I see great opportunity. Pat and his team are world class researchers with an incredible depth of drug development expertise, and I am really excited to see what we can accomplish together. Pascal has compelling drug candidates and some discovery programs that target unique biology fundamental for a number of large market disease indications. I joined as CEO because I believe the current market capitalization of Pascal does not reflect the potential of these assets, and I see an opportunity for significant value creation in both the short and long term. Our immediate priority will be demonstrating to shareholders the value of this team, and the value they can add to a scientifically, and fiscally, judicious development program. We look forward to releasing further updates in the near future.

Dr. Bapty takes over from the previous CEO Robert Gietl. On January 3, 2022, Mr. Gietl was terminated as CEO and president. Mr. Gietl has commenced a legal action in the Supreme Court of B.C. claiming damages, interest and costs, payment of unpaid salary of $230,000 and the issue of 500,000 shares. The Company has issued the 500,000 shares and filed a statement of defence.

On March 1, 2022 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage genome editing company focused on developing potentially curative therapeutics leveraging CRISPR-based technologies, reported that the first patient has been dosed with NTLA-5001, the company’s ex vivo CRISPR/Cas9 genome editing candidate for the treatment of acute myeloid leukemia (AML) (Press release, Intellia Therapeutics, MAR 1, 2022, View Source [SID1234609321]). NTLA-5001 is an autologous T cell receptor (TCR)-T cell therapy designed to target the Wilms’ Tumor (WT1) antigen, which is found in AML and many other hematologic and solid tumors. It is the company’s first ex vivo candidate developed using Intellia’s advanced lipid nanoparticle cell engineering platform, designed to improve cell performance as compared to traditional ex vivo delivery technologies.

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"As Intellia’s first wholly-owned ex vivo candidate to be dosed in a patient, this NTLA-5001 milestone represents a significant step forward in our full-spectrum approach to genome editing," said Intellia President and Chief Executive Officer John Leonard, M.D. "AML is the most common type of acute leukemia in adults, where despite recent advancements, a significant therapeutic need still exists. We look forward to advancing this investigational engineered cell therapy as a treatment for people living with this aggressive cancer of the blood and bone marrow."

About the NTLA-5001 Clinical Program

The Phase 1/2a study will evaluate the safety, tolerability, cell kinetics and anti-tumor activity of a single dose of NTLA-5001 in adults who have detectable AML after having received standard first-line therapy. The study includes a dose escalation and expansion phase, with up to 54 total participants. The dose-escalation phase of the study includes two independent arms of up to three cohorts each: Arm 1 consists of adults with AML with lower disease burden, defined as those with less than 5% blasts in bone marrow, while Arm 2 consists of adults with AML with higher disease burden, defined as those with greater than or equal to 5% blasts in bone marrow. Once a dose is identified in each arm, two expansion cohorts will be opened for further safety assessment. Visit clinicaltrials.gov (NCT05066165) for more details.

About NTLA-5001

NTLA-5001 is an investigational CRISPR/Cas9-engineered T cell receptor (TCR)-T cell therapy in development for the treatment of all genetic subtypes of acute myeloid leukemia (AML). This autologous cell therapy candidate is designed for AML patients with the HLA-A*02:01 allele and whose tumors carry the Wilms’ Tumor 1 (WT1) antigen, which is widely overexpressed in AML and other cancers. NTLA-5001 is Intellia’s first wholly owned ex vivo therapeutic candidate, developed using its proprietary cell engineering platform for the treatment of cancer. Based on preclinical results, Intellia believes its proprietary cell engineering platform will result in a pipeline of more efficacious and safer cell-based cancer therapies.

About Acute Myeloid Leukemia

Acute myeloid leukemia (AML) is a cancer of the blood and bone marrow that is rapidly fatal without immediate treatment. It is the most common type of acute leukemia in adults in the U.S., with more than 20,000 estimated new cases in 2021. Despite currently available treatments for AML, the five-year overall survival rate for patients remains less than 30%. AML, along with other cancer types, is often characterized by overexpression of the Wilms’ Tumor 1 (WT1) antigen.