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.

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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"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.