On March 1, 2022 Quanterix Corporation (NASDAQ: QTRX), a company digitizing biomarker analysis with the goal of advancing the science of precision health, reported financial results for the fourth quarter and twelve months ending December 31, 2021 (Press release, Quanterix, MAR 1, 2022, View Source [SID1234609337]).

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"We‘ve reached an important inflection point with the achievement of several key milestones, namely, our license and collaboration agreements with Eli Lilly, FDA Breakthrough Device Designation for plasma pTau-181 for Alzheimer’s disease (AD), and ending a strong 2021 with another record quarter. We have nearly $400 million on our balance sheet and the recruitment of several key executives that strengthen both RUO and diagnostics potential," said Kevin Hrusovsky, Chairman and Chief Executive Officer, Quanterix. "With our new agreements in place, we now have access to Lilly’s marquis P-tau217 antibody technology for AD and a collaboration framework for future projects across all disease categories. As we build our franchise in 2022, we look forward to partnering with other bio-pharmaceuticals, payors, researchers, and investors to unlock the massive opportunity for asymptomatic medicine using precision health proteomics."

Quanterix also announced the Company’s executive leadership succession plan. Effective April 25, 2022, President Masoud Toloue will succeed Chairman & Chief Executive Officer Kevin Hrusovsky as CEO and join Quanterix’ Board of Directors. Hrusovsky will move into an active Executive Chairman role, continuing to serve on the Board and support key strategic initiatives and important customer, partner and investor relationships. For more information on the succession plan, please see the full release issued today.

Fourth Quarter 2021 Financial Highlights

Key financial results for the fourth quarter of 2021 are shown below:

•Q4 GAAP total revenue, which includes grant revenue of $1.0M, was $30.3M versus prior year Q4 of $26.1M, which included grant revenue of $4.5M, an increase of 16%;

•Q4 non-GAAP total revenue was $29.3M versus prior year Q4 of $21.6M, an increase of 35%;

•Q4 GAAP product revenue was $23.5M versus prior year Q4 of $15.7M, an increase of 49%;

•Q4 GAAP service and other revenue was $5.7M versus prior year Q4 of $5.5M, an increase of 3%;

•Q4 GAAP gross margin was 53.7% versus prior year Q4 of 57.6%; and

•Q4 non-GAAP gross margin was 53.5% versus prior year Q4 of 50.8%.

Full Year 2021 Financial Highlights

Key financial results for FY 2021 are shown below:

•FY GAAP total revenue, which includes grant revenue of $5.2M, was $110.6M versus prior year FY of $86.4M; which included one-time license revenue of $11.2M and grant revenue of $6.4M, an increase of 28%;

•FY non-GAAP total revenue was $105.3M versus prior year FY of $68.8M, an increase of 53%;

•FY GAAP product revenue was $81.1M versus prior year FY of $44.0M, an increase of 84%;

•FY GAAP service and other revenue was $23.6M versus prior year FY of $24.1M, a decrease of 2%;

•FY GAAP gross margin was 55.8% versus prior year FY of 55.8%; and

•FY non-GAAP gross margin was 55.4% versus prior year FY of 49.2%.

For additional information on the non-GAAP financial measures included in this press release, please see "Use of Non-GAAP Financial Measures" and "Reconciliation of Non-GAAP Financials" below.

Fourth Quarter and Full Year Business Highlights

•The Company strengthened its balance sheet by successfully raising $287.5 million in gross proceeds through a follow-on offering completed in Q1. Quanterix had $399.0 million in cash, cash equivalents and restricted cash on the balance sheet as of December 31, 2021.

•Quanterix’ Simoa phospho-Tau 181 (pTau-181) blood test was granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA) as an aid in diagnostic evaluation of Alzheimer’s disease.

•The FDA expanded the Emergency Use Authorization (EUA) label for Quanterix’ Simoa SARS-CoV-2 N Protein Antigen Test to include testing with nasal swab and saliva samples, and for asymptomatic serial testing with nasal swab samples. The expanded label established this test as the first antigen test authorized for use with saliva samples.

•Quanterix’ Simoa HD-X technology and assays were used to measure pTau217 using antibodies developed by Eli Lilly and Company for its Phase 2 TRAILBLAZER-ALZ study, which was presented by Lilly at the Alzheimer’s Association International Conference (AAIC) 2021.

•Following the FDA approval of ADUHELM, Biogen conducted biomarker studies on Phase 3 EMERGE and ENGAGE trial samples, utilizing Quanterix’ Simoa HD-X to measure plasma pTau-181. Dr. Oskar Hansson from University of Lund reported preliminary data showing a dose-dependent reduction in plasma pTau-181 levels following treatment with ADUHELM, which correlated with decreases in brain amyloid as measured by PET scan and a slowing of cognitive decline across four independent assessment tools.

•Instrument installations increased by 32% in 2021 to 708 at year-end, with many HD-X instruments being used for neuro-related applications.

•Quanterix’ Simoa technology powered the largest and most diverse global investigation in the role of plasma neurofilament light (NfL) for dementia diagnosis, published in Nature Communications. The research marks the most robust effort to date to assess the use of NfL in blood to screen for neurodegeneration as a cause of cognitive symptoms, to differentiate among neurodegenerative disorders and distinguish psychiatric disorders, and to derive age-related concentration cutoffs that may help to maximize plasma NfL’s usefulness in a clinical setting.

•Data presented at the 2021 Clinical Trials on Alzheimer’s Disease (CTAD) conference described a prototype Simoa plasma pTau-231 assay and its potential role in detecting Alzheimer’s disease pathology. This emerging biomarker allows for detection even earlier in the disease continuum, when patients are asymptomatic and not yet exhibiting brain pathology in PET imaging studies.

•The Company welcomed Masoud Toloue, with a high growth track record from PerkinElmer, to the position of President of Quanterix and Diagnostics. The Company subsequently accounced its executive transition plan as noted above. The Company also appointed Michael Doyle, a strong financial executive with deep public company experience, to the position of Chief Financial Officer and Treasurer. Laurie Olson, a seasoned industry executive who brings more than three decades of experience in commercial and corporate strategy from Pfizer, Inc., joined Quanterix’ Board of Directors.

•Quanterix was named a finalist for the Deloitte Fast 500 list, which ranks the fastest-growing technology, media, telecommunications and life sciences companies based in North America. The annual ranking is based on percentage revenue growth over the Company’s last three fiscal years.

•Academic publication pull-through performance continued to be strong. Quanterix’ Simoa technology was highlighted in a record 465 new publications in 2021, bringing total Simoa-specific inclusions to over 1,585.

Conference Call

In conjunction with this announcement, Quanterix Corporation will host a conference call on March 1, 2022 at 8:30 a.m. EST. Individuals interested in listening to the conference call may do so by dialing (833) 686-9351 for domestic callers, or (612) 979-9890 for international callers. Please reference the following Conference ID: 5230769.

A live webcast will also be available at: View Source You may also access the live webcast by visiting the News & Events page within the Investors section of the Quanterix website at www.quanterix.com. The webcast will be available on the Company’s website for one year following completion of the call.

On March 1, 2022 PMV Pharmaceuticals, Inc. (Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53, reported financial results for the fourth quarter and full year ended December 31, 2021 and provided corporate highlights (Press release, PMV Pharma, MAR 1, 2022, View Source [SID1234609336]).

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"We expect that 2022 will be another productive year for PMV Pharma, following accomplishments across multiple fronts in 2021," said David Mack, Ph.D., President and Chief Executive Officer. "We are encouraged by the steady progress in the development of our lead candidate PC14586, an investigational small molecule p53 Y220C reactivator, and look forward to reporting initial data from our ongoing Phase 1/2 trial in the first half of 2022. Our strong leadership and balance sheet position us to further advance our discovery pipeline of small molecule, tumor-agnostic precision medicine products that specifically target p53 mutants and targets where wild-type p53 is silenced."

Fourth Quarter 2021 and Corporate Highlights:

Patient enrollment in the Phase 1 portion of the Phase 1/2 clinical trial of PC14586 continues in line with the Company’s expectations. The Phase 1 dose escalation is assessing the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of PC14586 in patients with advanced solid tumors that have a p53 Y220C mutation (NCT04585750). The Company plans to disclose initial results from this study in the first half of 2022.

In addition to continuing work on its p53 mutant programs, PMV expands its pipeline by advancing WIP1 (Wild-Type p53-Induced Phosphatase) inhibitor program, into lead optimization. WIP1 is a phosphatase that negatively regulates wild-type p53 as well as other proteins involved in the DNA damage response pathway.

Promotions of Binh Vu Ph.D. to Senior Vice President, Discovery Research and CMC and Melissa Dumble Ph.D. to Senior Vice President, Preclinical Development and Translational Science. Dr. Vu joined PMV Pharma in 2013 as its first employee and has been an integral part of the company over the past 8 years. He will continue to lead our discovery research and CMC activities. Dr. Dumble joined PMV Pharma in 2017 and has played an important role in developing our pipeline. She will continue to lead our preclinical development and translational science activities.

Appointment of Kirsten Flowers to our Board of Directors. Ms. Flowers is the Chief Commercial Officer of Kura Oncology, a clinical-stage precision oncology company, who has extensive commercial experience leading top-performing oncology product launches at large pharmaceutical and biotechnology organizations. Prior to Kura Oncology, she served as Senior Vice President, Commercial Operations at Array Biopharma, where she built and led the commercial organization that delivered the successful launch of Braftovi + Mektovi for patients with BRAF-mutant melanoma.

Previously, she held various commercial leadership roles at Pfizer, including serving as the U.S. commercial lead for the launch of the blockbuster drug IBRANCE in breast cancer and for the launch of INLYTA in renal cell carcinoma.

Fourth Quarter 2021 Financial Results

PMV Pharma ended the fourth quarter with $314.1 million in cash, cash equivalents, and marketable securities, compared to $361.4 million as of December 31, 2020. Net cash used in operations was $46.6 million for the twelve months ended December 31, 2021 compared to $32.7 million for the twelve months ended December 31, 2020.

Net loss for the year ended December 31, 2021 was $57.8 million compared to $34.4 million for the year ended December 31, 2020.

Research and development (R&D) expenses were $36.5 million for the year ended December 31, 2021 compared to $23.9 million for the year ended December 31, 2020. The increase in R&D expenses was primarily related to increased headcount and clinical expenses related to advancing research on PC14586, the Company’s lead drug candidate.

General and administrative (G&A) expenses were $21.8 million for the year ended December 31, 2021, compared to $11.0 million for the year ended December 31, 2020. The increase in G&A expenses was primarily due to expanding the infrastructure necessary for operating as a public company.

About PC14586

PC14586 is a first-in-class, small molecule, p53 reactivator designed to selectively bind to the crevice present in the p53 Y220C mutant protein, hence, restoring the wild-type, or normal, p53 protein structure and tumor suppressing function. PC14586 is being developed for the treatment of patients with locally advanced or metastatic solid tumors that have a p53 Y220C mutation.

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.