On May 3, 2023 Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, reported financial results for the first quarter ended March 31, 2023 and provided a corporate update (Press release, Deciphera Pharmaceuticals, MAY 3, 2023, View Source [SID1234630910]).

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"We have had a very strong start to 2023, achieving significant milestones including the completion of enrollment for the MOTION pivotal Phase 3 study of vimseltinib in TCGT patients, presentation of the ctDNA data for QINLOCK in second-line GIST patients with mutations in KIT Exon 11 and 17/18, and receiving Breakthrough Therapy Designation from the FDA for QINLOCK in this patient population," said Steve Hoerter, President and Chief Executive Officer of Deciphera Pharmaceuticals. "These advancements in our late-stage pipeline position us for a catalyst-rich remainder of 2023, in which we expect top-line results from the MOTION study and plan to initiate INSIGHT, the pivotal Phase 3 study of QINLOCK versus sunitinib in second-line GIST patients with mutations in KIT exon 11 and 17/18."

Mr. Hoerter continued, "We continue to complement this impressive momentum with progress in our early-stage programs, including the recent presentations at AACR (Free AACR Whitepaper), which highlighted the productivity of our kinase switch-control research engine. We were excited to present the preclinical data for DCC-3084, a potential best-in-class pan-RAF inhibitor, and announce the nomination of our newest development candidate, DCC-3009, a potential best-in-class pan-KIT inhibitor. We also presented preclinical data supporting the study of DCC-3116 in combination with QINLOCK in GIST and with encorafenib and cetuximab in colorectal cancer. This encouraging progress demonstrates that, as we work toward becoming a company with multiple approved medicines, our proprietary drug discovery platform continues to fuel our pipeline with innovative, potential first- and best-in-class kinase inhibitors."

First Quarter 2023 Highlights and Upcoming Milestones

QINLOCK (ripretinib)

Recorded $33.2 million in QINLOCK net product revenue in the first quarter of 2023, including $24.6 million in U.S. net product revenue and $8.6 million in international net product revenue, an increase of 15% compared to net product revenue of $28.8 million in the first quarter of 2022.
Granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumor (GIST) who received prior treatment with imatinib, and who harbor a KIT exon 11 mutation and co-occurring KIT exon 17 and/or 18 mutations. The Company expects to initiate the INSIGHT study in the second half of 2023.
Included in the latest National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology as a preferred regimen for second-line GIST patients intolerant to sunitinib.
Will present posters at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting featuring updated overall survival (OS) and outcome data on patients without circulating tumor DNA (ctDNA) at baseline from the INTRIGUE Phase 3 study of QINLOCK in patients with advanced GIST previously treated with imatinib, along with information on the upcoming INSIGHT pivotal Phase 3 study of QINLOCK versus sunitinib in second-line GIST patients with KIT exon 11 and 17/18 mutations.
Concluded successful price negotiations in Germany. In 2022, QINLOCK received a "major additional benefit" rating from Germany’s Federal Joint Committee (G-BA). QINLOCK is the first orphan oncology treatment in Germany to receive this rating for its lead indication and the only GIST treatment awarded with this recognition.
Vimseltinib

Completed enrollment for the MOTION pivotal Phase 3 study of vimseltinib, an investigational, orally administered, potent, and highly selective switch-control kinase inhibitor of CSF1R for the potential treatment of tenosynovial giant cell tumor (TGCT) and expects to announce top-line results from the study in the fourth quarter of 2023.
Expects to present updated data from the Phase 1/2 study of vimseltinib in the second half of 2023.
DCC-3116

Presented preclinical data on combinations with DCC-3116, an investigational, orally administered, selective, and potent switch-control kinase inhibitor of ULK1/2-mediated autophagy, at the American Association for Cancer (AACR) (Free AACR Whitepaper) Annual Meeting 2023, including preclinical models in combination with ripretinib in GIST models and with encorafenib and cetuximab in colorectal cancer (CRC) models.
Expects to initiate new combination escalation studies evaluating DCC-3116 in combination with ripretinib in patients with GIST and in combination with encorafenib and cetuximab in patients with CRC in the second half of 2023. Under the terms of the clinical trial collaboration and supply agreement with Pfizer, Inc., Deciphera will sponsor the study and Pfizer will supply encorafenib at no cost.
Expects to initiate one or more expansion cohorts in the ongoing Phase 1/2 study of DCC-3116 in the second half of 2023 in combination with the MEK inhibitors trametinib or binimetinib, or the KRAS G12C inhibitor sotorasib.
DCC-3084

Presented preclinical data for DCC-3084, a pan-RAF inhibitor, at the AACR (Free AACR Whitepaper) Annual Meeting 2023, which demonstrated a potential best-in-class profile based on its inhibition of Class I, II, and III BRAF mutations, BRAF fusions, and BRAF/CRAF heterodimers, and optimized pharmaceutical properties.
Expects to submit an investigational new drug (IND) application to the FDA for DCC-3084 in the second half of 2023.
DCC-3009

Presented preclinical data for DCC-3009, a potential best-in-class pan-KIT inhibitor, at the AACR (Free AACR Whitepaper) Annual Meeting 2023, which demonstrated its ability to potently and selectively inhibit the broad spectrum of known primary and secondary drug-resistant mutations in GIST models, spanning KIT exons 9, 11, 13, 14, 17, and 18.
Expects to submit an IND to the FDA for DCC-3009 in the first half of 2024.
Kinase Switch-Control Research Engine

Presented new preclinical data from research programs focused on GCN2 and PERK, novel targets in the integrated stress response pathway, at the AACR (Free AACR Whitepaper) Annual Meeting 2023.
Corporate Update

Announced the closing in January 2023 of its underwritten public offering of 7,986,111 shares of its common stock at a public offering price of $18.00. The aggregate gross proceeds to Deciphera from this offering were approximately $143.7 million, before deducting underwriting discounts and commissions and other estimated offering expenses.
First Quarter 2023 Financial Results

Revenue: Total revenue for the first quarter of 2023 was $33.4 million, which includes $33.2 million of net product revenue of QINLOCK and $0.2 million of collaboration revenue compared to $29.2 million of total revenue, including $28.8 million of net product revenue of QINLOCK and $0.4 million of collaboration revenue, for the same period in 2022.
Cost of Sales: Cost of sales were $0.5 million in the first quarter of 2023, which includes $0.4 million in cost of product sales, compared to cost of sales of $0.4 million for the first quarter of 2022. In the third quarter of 2022, Deciphera completed the sale of zero cost inventories of QINLOCK that had been expensed prior to FDA approval.
R&D Expenses: Research and development expenses for the first quarter of 2023 were $54.8 million, compared to $47.4 million for the same period in 2022. The increase was primarily due to an increase in clinical study costs related to the MOTION Phase 3 study of vimseltinib, the Phase 1/2 study of DCC-3116, and clinical study costs for QINLOCK, including the Phase 3 INTRIGUE study. Non-cash, stock-based compensation was $5.4 million and $6.3 million for the first quarters of 2023 and 2022, respectively.
SG&A Expenses: Selling, general, and administrative expenses for the first quarter of 2023 were $31.4 million, compared to $28.3 million for the same period in 2022. The increase was primarily due to an increase in professional, consulting, and other expenses, partially offset by a decrease in personnel-related costs. Non-cash, stock-based compensation was $7.0 million and $8.0 million for the first quarters of 2023 and 2022, respectively.
Net Loss: For the first quarter of 2023, Deciphera reported a net loss of $49.6 million, or $0.60 per share, compared with a net loss of $46.9 million, or $0.80 per share, for the same period in 2022.
Cash Position: As of March 31, 2023, cash, cash equivalents, and marketable securities were $426.3 million, compared to $339.0 million as of December 31, 2022. Based on its current operating plans, Deciphera expects its current cash, cash equivalents, and marketable securities together with anticipated product, royalty, and supply revenues, but excluding any potential future milestone payments under its collaboration or license agreements, will enable the Company to fund its operating and capital expenditures into 2026.
Conference Call and Webcast

Deciphera will host a conference call and webcast to discuss this announcement today, May 3, 2023, at 8:00 AM ET. The conference call may be accessed via this link: https://register.vevent.com/register/BI75fb53c225a648b486e50d922b166468. A live webcast of the conference call will be available in the "Events and Presentations" page in the "Investors & News" section of the Company’s website at View Source A replay will be available on the Company’s website approximately two hours after the conference call and will be available for 30 days following the call.

On May 3, 2023 CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases, reported that management will be participating in fireside chats and investor meetings at both the JMP Securities Life Sciences Conference being held in New York on May 15 – 16, 2023 and the 2023 RBC Capital Markets Global Healthcare Conference being held in New York on May 16 – 17, 2023. Details for each fireside chat is as follows (Press release, CorMedix, MAY 3, 2023, View Source [SID1234630909]):

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JMP Securities Life Sciences Conference
Date: Tuesday, May 16, 2023
Time: 11:30am EDT
Webcast: Click here

RBC Capital Markets Global Healthcare Conference
Date: Wednesday, May 17, 2023
Time: 2:35pm EDT
Webcast: Click here

A replay of each fireside chat will also be available in the "Events and Presentations" page on the investor relations portion of the Company’s website at: www.cormedix.com

On May 3, 2023 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrine, oncologic, metabolic and neurological disorders by modulating the effects of the hormone cortisol, reported its results for the quarter ended March 31, 2023 (Press release, Corcept Therapeutics, MAY 3, 2023, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announces-first-quarter-financial-results-0 [SID1234630908]).

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Financial Results

Revenue of $105.7 million, compared to $93.7 million in first quarter 2022
Raised 2023 revenue guidance to $435 – $455 million, from $430 – $450 million
Net income per common share of $0.14 (diluted), compared to $0.20 in first quarter 2022
Cash and investments of $465.1 million as of March 31, 2023
Purchase of 6.6 million shares of Corcept common stock for $145.4 million in April 2023
Corcept’s first quarter 2023 revenue was $105.7 million, compared to $93.7 million in the first quarter of 2022. First quarter operating expenses were $90.8 million, compared to $66.9 million in the first quarter of 2022, due to increased spending on clinical trials and sales and marketing activities and to support the expansion of our clinical development and commercial teams. Net income was $15.9 million in the first quarter of 2023 compared to $22.8 million in the same period last year.

Cash and investments were $465.1 million at March 31, 2023 compared to $436.6 million at December 31, 2022. In April 2023, Corcept purchased 6.6 million shares of its common stock for $145.4 million.

"Korlym is an excellent treatment for patients with Cushing’s syndrome and there are many eligible patients who have yet to receive it. We are making substantial investments to improve the ability of physicians to identify and treat patients with hypercortisolism, most notably our recently established CATALYST study, and are optimistic about the growth of our Cushing’s syndrome business. We are raising our 2023 revenue guidance to $435 – $455 million," said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer.

Clinical Development

"In the next twelve months we expect data from our GRACE, GRADIENT and NASH Phase 1b studies, submission of the NDA for relacorilant in Cushing’s syndrome, completion of enrollment of our CATALYST, ROSELLA and DAZALS studies and initiation of a Phase 2b trial of miricorilant in patients with NASH," added Dr. Belanoff.

Cushing’s Syndrome

Phase 3 GRACE trial of relacorilant as a treatment for patients with all etiologies of Cushing’s syndrome – new drug application (NDA) submission expected in the first half of 2024
Enrollment continues in Phase 3 GRADIENT trial of relacorilant as a treatment for patients with Cushing’s syndrome caused by adrenal adenomas
Enrollment continues in CATALYST – 1,000-patient Phase 4 trial examining the prevalence of hypercortisolism in patients with difficult to control type 2 diabetes; patients with hypercortisolism may enter a randomized, double-blind, placebo-controlled study of Korlym
Our GRACE trial will serve as the basis for relacorilant’s NDA in Cushing’s syndrome, which we plan to submit in the first half of 2024. We are pleased to share that we have identified all the patients necessary to complete this study and expect to complete enrollment in the coming weeks. Our Phase 3 GRADIENT trial will produce valuable data about an etiology of Cushing’s syndrome that affects many patients but has not been rigorously examined in a controlled study.

"Independent studies conducted over the last fifteen years have found that the prevalence of hypercortisolism in patients with type 2 diabetes is substantially higher than in the general population. The most prominent diabetologists in the United States helped us design and are participating in our CATALYST trial, which will be the largest study of its kind and is now enrolling patients. CATALYST identifies patients whose diabetes is caused by hypercortisolism and offers them a placebo-controlled study where Korlym is the active treatment. We expect to complete enrollment by the end of this year," said Bill Guyer, PharmD, Corcept’s Chief Development Officer.

Oncology

Enrollment continues in ROSELLA – 360-patient pivotal Phase 3 trial of relacorilant plus nab-paclitaxel in patients with recurrent, platinum-resistant ovarian cancer
Enrollment continues in open-label, Phase 1b trial of relacorilant plus pembrolizumab in patients with adrenal cancer with cortisol excess
Randomized, placebo-controlled Phase 2 trial of relacorilant plus enzalutamide in patients with prostate cancer expected to begin by mid-year in collaboration with the University of Chicago
"We and our investigators are excited to advance relacorilant in platinum-resistant ovarian cancer. Relacorilant plus nab-paclitaxel has the potential to become a new standard of care for the treatment of patients with this dire disease. We are on track to complete enrollment in ROSELLA by the end of this year," said Dr. Guyer.

Amyotrophic Lateral Sclerosis (ALS)

Enrollment continues in DAZALS – 198-patient, randomized, double-blind, placebo-controlled Phase 2 trial of dazucorilant in patients with ALS
"ALS, commonly known as Lou Gehrig’s disease, is a devastating illness with an urgent need for better treatment. We are conducting our DAZALS study in collaboration with TRICALS, the leading ALS academic consortium in Europe, to investigate dazucorilant’s potential to significantly improve the lives of patients with ALS. We are on track to complete enrollment in DAZALS by early 2024," said Dr. Guyer.

Non-alcoholic Steatohepatitis (NASH)

Enrollment completed in Phase 1b dose-finding trial of miricorilant in patients with presumed NASH – data expected by mid-year; Phase 2b trial to begin in the fourth quarter
"Miricorilant, a potent, oral, selective cortisol modulator with targeted activity in the liver, continues to demonstrate great promise as a treatment for NASH. Our Phase 1b study has identified a range of doses, all substantially lower than our originally tested doses, that significantly reduce liver fat without causing excessive liver irritation," said Dr. Guyer. "We expect to share results from this study by mid-year and plan to start a Phase 2b trial in the fourth quarter of this year."

Conference Call

We will hold a conference call on May 3, 2023, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). Participants must register in advance of the conference call by clicking here. Upon registering, each participant will receive a dial-in number and a unique access PIN. Each access PIN will accommodate one caller. Additionally, a listen-only webcast will be available by clicking here. A replay of the call will be available on the Investors / Events tab of www.corcept.com.

Hypercortisolism

Hypercortisolism, often referred to as Cushing’s syndrome, is caused by excessive activity of the hormone cortisol. Endogenous Cushing’s syndrome is an orphan disease that most often affects adults aged 20-50. In the United States, an estimated 20,000 patients have Cushing’s syndrome, with about 3,000 new patients diagnosed each year. Symptoms vary, but most patients experience one or more of the following manifestations: high blood sugar, diabetes, high blood pressure, upper-body obesity, rounded face, increased fat around the neck, thinning arms and legs, severe fatigue and weak muscles. Irritability, anxiety, cognitive disturbances and depression are also common. Hypercortisolism can affect every organ system and can be lethal if not treated effectively. Corcept holds patents directed to the composition of relacorilant and the use of cortisol modulators, including Korlym, in the treatment of patients with hypercortisolism.

On May 3, 2023 Circio Holding ASA (formerly Targovax ASA*) (OSE: TRVX) reported that an abstract describing its circular RNA platform has been accepted for poster presentation at the 2023 American Society of Gene + Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting in Los Angeles, USA (Press release, Circio, MAY 3, 2023, View Source [SID1234630907]).

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The abstract describes the development of Circio’s proprietary circAde vector system for therapeutic protein expression. Key elements necessary for circRNA biogenesis were systematically screened and optimized to facilitate high yield circRNA expression. Additionally, protein expression from the circAde vector was found to outperform conventional mRNA-based designs, both in terms of protein expression level and durability in vitro. Our results highlight the potential of the circAde platform for the development of novel, more effective strategies for the treatment of diseases in which durable transgene expression is desirable.

The poster is scheduled for presentation Thursday 18 May 2023 and will be available on Circio’s website after the presentation.

Poster title: circAde, a Vector System for Spliceosome Dependent circRNA Biogenesis and Prolonged More Effective Protein Expression
Date and time: Thursday 18 May 2023, 12:00- 13:30 PDT / 21:00-22:30 CEST
Location: The Los Angeles Convention Center in Los Angeles, CA
Poster number: 1095
Presenter: Eoghan O’Leary, Director RNA Research
About ASGCT (Free ASGCT Whitepaper)

The American Society of Gene and Cell Therapy’s (ASGCT) (Free ASGCT Whitepaper) Annual Meeting is the premier event for professionals in gene and cell therapy. The meeting is the best place for people in the field to learn from the latest scientific research, stay up to date on new technologies, and make career-advancing connections with peers.

Originally designed as a venue for academic researchers to share their work, the Annual Meeting has grown to serve a wide community encompassing clinicians, bio-industry development, regulatory agencies, equipment manufacturers, patient advocates, and more.

*) Targovax ASA, which is changing its company name to Circio Holding ASA, has called for an AGM on 22 May 2023, to vote for the approval of the change of its company name from Targovax ASA to Circio Holding ASA.

On May 3, 2023 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported its financial results for the first quarter ended March 31, 2023 (Press release, Castle Biosciences, MAY 3, 2023, View Source [SID1234630906]).

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"Castle delivered a strong start to the year," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "Building on our strength and momentum from 2022, we delivered significant test report volume and revenue growth in the first quarter, which was driven by continued execution on our short- and long-term strategies. We remain confident in our business and are reaffirming our 2023 revenue guidance.

"Investments in our growth initiatives across our entire test portfolio, coupled with the team’s performance, continue to support the adoption of our proprietary tests. In particular, the evolution of our dermatology facing commercial team in the third quarter of 2022 helped drive first quarter test report volume for DecisionDx-Melanoma and DecisionDx-SCC combined, which grew nearly 40% year-over-year and nearly 10% sequentially.

Additionally, we acquired two companies over the last eighteen months that we believe will contribute to long-term value creation. We were pleased to see the continued momentum in test report volumes we expected in these newer gastroenterology and mental health franchises, which we believe are on track to be important contributors to delivering on our financial targets.

First Quarter Ended March 31, 2023, Financial and Operational Highlights
•Revenues were $42.0 million, a 57% increase compared to $26.9 million during the same period in 2022. Included in revenue for the period were revenue adjustments related to tests delivered in prior periods. These prior period revenue adjustments for the quarter ended March 31, 2023, were $1.3 million of net negative revenue adjustments, compared to $0.6 million of net positive revenue adjustments for the same period in 2022.
•Adjusted revenues, which exclude the effects of revenue adjustments related to tests delivered in prior periods, were $43.4 million, a 65% increase compared to $26.3 million for the same period in 2022.
•Delivered 14,916 total test reports in the first quarter of 2023, an increase of 73% compared to 8,627 in the same period of 2022:
◦DecisionDx-Melanoma test reports delivered in the quarter were 7,583, compared to 6,023 in the first quarter of 2022, an increase of 26%. DecisionDx-Melanoma test reports delivered in the fourth quarter of 2022 were 7,301.
◦DecisionDx-SCC test reports delivered in the quarter were 2,411, compared to 1,142 in the first quarter of 2022, an increase of 111%. DecisionDx-SCC test reports delivered in the fourth quarter of 2022 were 1,845.
◦MyPath Melanoma test reports delivered in the quarter were 980, compared to 950 MyPath-Melanoma and DiffDx-Melanoma aggregate test reports in the first quarter of 2022, an increase of 3%. MyPath and DiffDx-Melanoma aggregate test reports delivered in the fourth quarter of 2022 were 822.
◦DecisionDx-UM test reports delivered in the quarter were 409, compared to 456 in the first quarter of 2022, a decrease of 10%. DecisionDx-UM test reports delivered in the fourth quarter of 2022 were 432.

◦TissueCypher Barrett’s Esophagus test reports delivered in the quarter were 1,383, compared to 56 in the first quarter of 2022, following our initial offering of the test beginning in December 2021. TissueCypher Barrett’s Esophagus test reports delivered in the fourth quarter of 2022 were 1,030.
◦IDgenetix test reports delivered in the quarter were 2,150. We began offering the IDgenetix test in April 2022, and thus no test reports were delivered by Castle in the first quarter of 2022. IDgenetix test reports delivered in the fourth quarter of 2022 were 1,214.
•Gross margin for the quarter ended March 31, 2023, was 70.5%, and adjusted gross margin was 76.5%.
•Net cash used in operations was $25.4 million, compared to $21.4 million for the same period in 2022. First quarter 2023 cash use reflects payout of employee annual cash bonuses as well as certain health care benefit payments, totaling $17.7 million, that are not expected to recur during the remainder of 2023.
•Net loss for the first quarter, which includes non-cash stock-based compensation expense of $13.5 million, was $(29.2) million, compared to $(24.6) million for the same period in 2022.
•Adjusted EBITDA for the first quarter was $(15.1) million, compared to $(11.4) million for the same period in 2022.
Cash, Cash Equivalents and Marketable Investment Securities
As of March 31, 2023, the Company’s cash, cash equivalents and marketable investment securities totaled $232.1 million.
2023 Outlook
The Company reaffirms its previously provided 2023 total revenue guidance of $170-180 million.
First Quarter and Recent Accomplishments and Highlights
Dermatology
•Earlier today, the Company announced the publication of an independent, retrospective multi-center study in the Archives of Dermatological Research providing a direct chain of evidence that use of DecisionDx-Melanoma test results to guide radiological surveillance could lead to improved patient outcomes. The study, authored by Dhillon et al., can be found here. See the Company’s news release from May 3, 2023, for more information.
•In February, the Company announced the publication of data from a prospective, multicenter study, called DECIDE. In the study, DecisionDx-Melanoma test results influenced 85% of clinicians’ decisions regarding the sentinel lymph node biopsy (SLNB) surgical procedure. Additionally, use of the tests’ results within current guideline recommendations led to a significant reduction in SLNB procedures performed, demonstrating the clinical value of the test to guide risk-aligned patient care. The publication can be found here.
•In March, the Company announced the publication of a consensus panel report from the National Society for Cutaneous Medicine recommending use of gene expression profile (GEP) testing in the clinical assessment and management of cutaneous melanoma (CM). The report provides usage guidelines and a framework for clinicians to integrate GEP testing into their CM patient management. Additionally, the consensus report endorses Castle’s DecisionDx-Melanoma GEP risk stratification test as offering more utility than other existing CM GEP assays or nomograms, supported by extensive, evidence-driven data in current literature. See the Company’s news release from March 8, 2023, for more information.
•In March, the Company shared new performance data from a novel, multi-center, independent cohort demonstrating how the independent risk-stratification of DecisionDx-SCC can significantly improve metastatic risk predictions by complementing current staging systems, American Joint Committee on Cancer 8th edition staging system (AJCC8) and Brigham and Women’s Hospital staging system (BWH). Additionally, consistent with previous studies, DecisionDx-SCC independently and significantly stratified a novel cohort according to patients’ biologic metastatic risk (p<0.0001). This study analyzed the performance of the DecisionDx-SCC test in a novel, independent performance cohort of 534 patients with primary SCC and one or more risk factors from 45 contributing centers. The data from the

study consistently demonstrated the performance of DecisionDx-SCC to classify risk for metastasis in SCC patients with one or more risk factors (p<0.0001), and multivariate models showed the metastatic risk prediction of AJCC8 and BWH staging systems were significantly improved when DecisionDx-SCC test results were included. See the Company’s news release from March 18, 2023, for more information.
Corporate
•In February, the Company announced that it received a 2023 Top Workplaces USA award from Energage. This is the second year in a row that Castle has received this national award, recognizing the Company for its exceptional workplace culture. Recipients of the Top Workplaces USA award are chosen solely on employee feedback gathered through an anonymous employee engagement survey, issued by Energage. See the Company’s news release from Feb. 1, 2023, for more information.
•In February, the Company announced that its chief financial officer, Frank Stokes, was named to Finance & Investing’s Top 25 CFOs of Houston list for 2023. This year’s awardees are financial executives at the forefront of the rapid technological development occurring throughout Houston across key global industries, including energy, life sciences, manufacturing, logistics and aerospace. See the Company’s news release from Feb. 24, 2023, for more information.
Conference Call and Webcast Details
Castle Biosciences will hold a conference call on Wednesday, May 3, 2023, at 4:30 p.m. Eastern time to discuss its first quarter 2023 results and provide a corporate update.

A live webcast of the conference call can be accessed here: View Source or via the webcast link on the Investor Relations page of the Company’s website, View Source Please access the webcast at least 10 minutes before the conference call start time. An archive of the webcast will be available on the Company’s website until May 24, 2023.

To access the live conference call via phone, please dial 833 470 1428 from the United States, or +1 404 975 4839 internationally, at least 10 minutes prior to the start of the call, using the conference ID 083848.

There will be a brief Question & Answer session following management commentary.
Use of Non-GAAP Financial Measures (UNAUDITED)
In this release, we use the metrics of Adjusted Revenues, Adjusted Gross Margin and Adjusted EBITDA, which are non-GAAP financial measures and are not calculated in accordance with generally accepted accounting principles in the United States (GAAP). Adjusted Revenues and Adjusted Gross Margin reflect adjustments to GAAP net revenues to exclude net positive and/or net negative revenue adjustments recorded in the current period associated with changes in estimated variable consideration related to test reports delivered in previous periods. Adjusted Gross Margin further excludes acquisition-related intangible asset amortization. Adjusted EBITDA excludes from net loss interest income, interest expense, income tax expense (benefit), depreciation and amortization expense, stock-based compensation expense and change in fair value of contingent consideration.

We use Adjusted Revenues, Adjusted Gross Margin and Adjusted EBITDA internally because we believe these metrics provide useful supplemental information in assessing our revenue and operating performance reported in accordance with GAAP, respectively. We believe that Adjusted Revenues, when used in conjunction with our test report volume information, facilitates investors’ analysis of our current-period revenue performance and average selling price performance by excluding the effects of revenue adjustments related to test reports delivered in prior periods, since these adjustments may not be indicative of the current or future performance of our business. We believe that providing Adjusted Revenues may also help facilitate comparisons to our historical periods. Adjusted Gross Margin is calculated using Adjusted Revenues and therefore excludes the impact of revenue adjustments related to test reports delivered in prior periods, which we believe is useful to investors as described above. We further exclude acquisition-related intangible asset amortization in the calculation of Adjusted Gross Margin. We believe that excluding acquisition-related intangible asset amortization may facilitate gross margin comparisons to historical periods and may be useful in assessing current-period performance without regard to the historical accounting valuations of intangible assets, which

are applicable only to tests we acquired rather than internally developed. We believe Adjusted EBITDA may enhance an evaluation of our operating performance because it excludes the impact of prior decisions made about capital investment, financing, investing and certain expenses we believe are not indicative of our ongoing performance. However, these non-GAAP financial measures may be different from non-GAAP financial measures used by other companies, even when the same or similarly titled terms are used to identify such measures, limiting their usefulness for comparative purposes.

These non-GAAP financial measures are not meant to be considered in isolation or used as substitutes for net revenues, gross margin, or net loss reported in accordance with GAAP; should be considered in conjunction with our financial information presented in accordance with GAAP; have no standardized meaning prescribed by GAAP; are unaudited; and are not prepared under any comprehensive set of accounting rules or principles. In addition, from time to time in the future, there may be other items that we may exclude for purposes of these non-GAAP financial measures, and we may in the future cease to exclude items that we have historically excluded for purposes of these non-GAAP financial measures. Likewise, we may determine to modify the nature of adjustments to arrive at these non-GAAP financial measures. Because of the non-standardized definitions of non-GAAP financial measures, the non-GAAP financial measure as used by us in this press release and the accompanying reconciliation tables have limits in their usefulness to investors and may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by other companies. Accordingly, investors should not place undue reliance on non-GAAP financial measures. Reconciliations of these non-GAAP financial measures to the most directly comparable GAAP financial measures are presented in the tables at the end of this release.