On February 27, 2025 Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, reported pipeline and business progress, reiterated key anticipated milestones, and announced fourth quarter and full year 2024 financial results (Press release, Nuvalent, FEB 27, 2025, View Source [SID1234650712]).

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"The efficient execution by the Nuvalent team to date reflects a shared sense of urgency driven by patient need for additional treatment options – a need that we believe has been clearly demonstrated by the robust enrollment momentum in our ARROS-1 and ALKOVE-1 trials," said Darlene Noci, A.L.M., Chief Development Officer at Nuvalent. "We believe we are on track to report pivotal data for TKI pre-treated patients from both trials this year and to submit our first NDA by mid-year 2025."

Ms. Noci continued, "In parallel to advancing initial registration paths for zidesamtinib and neladalkib for TKI pre-treated patients, we continue to work with regulators towards our goal of bringing new therapies to all patients with ROS1-positive or ALK-positive NSCLC. Development programs for TKI-naïve patients are underway for both our ROS1 and ALK programs. To ensure patient access to these therapies, we are also pleased to announce the recent launch of global Expanded Access Programs for patients who are eligible and have no other treatment options outside of a clinical trial."

"As we transition towards becoming a fully integrated commercial-stage biopharmaceutical company, we reiterate our commitment to meeting the medical needs of patients by advancing our programs as quickly as possible," said James Porter, Ph.D., Chief Executive Officer at Nuvalent. "This is an important time for Nuvalent and with a steady cadence of anticipated milestones across our pipeline this year, a strong balance sheet and a dedicated and proven team at the helm, we believe we are well-positioned to deliver on our near-, mid- and long-term goals."

Recent Pipeline Progress and Anticipated Milestones

ROS1 Program

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Nuvalent has implemented a global Expanded Access Program (EAP) for zidesamtinib for eligible patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have previously received at least one prior ROS1 tyrosine kinase inhibitor (TKI) and lack satisfactory therapeutic alternatives and are unable to access zidesamtinib through a clinical trial.
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As of December 31, 2024, a total of 430 patients had been enrolled in the Phase 1 and Phase 2 portions of the ongoing ARROS-1 Phase 1/2 trial of zidesamtinib for patients with advanced ROS1-positive NSCLC and other solid tumors, which is designed with registrational intent for TKI pre-treated and TKI-naïve patients with advanced ROS1-positive NSCLC. The company expects to report pivotal data for TKI pre-treated patients with advanced ROS1-positive NSCLC in the first half of 2025 in support of an anticipated New Drug Application (NDA) submission by mid-year 2025, with an initial target indication of TKI pre-treated patients with advanced ROS1-positive NSCLC. The company plans to continue engagement with the U.S. Food and Drug Administration (FDA) on accelerated opportunities towards a potential line-agnostic indication supported by the ongoing TKI-naïve cohort in the Phase 2 portion of the ARROS-1 trial.
ALK Program

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Nuvalent has implemented a global EAP for neladalkib for eligible patients with locally advanced or metastatic ALK-positive NSCLC who have previously received lorlatinib or a second-generation ALK TKI and lack satisfactory therapeutic alternatives and are unable to access neladalkib through a clinical trial.
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As of December 31, 2024, a total of 596 patients had been enrolled in the Phase 1 and Phase 2 portions of the ongoing ALKOVE-1 Phase 1/2 trial of neladalkib for patients with advanced ALK-positive NSCLC and other solid tumors, which is designed with registrational intent for TKI pre-treated patients. The company expects to report pivotal data for TKI pre-treated patients with advanced ALK-positive NSCLC by year-end 2025.
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Nuvalent plans to initiate the ALKAZAR Phase 3 trial, its front-line development strategy for the company’s ALK program, in the first half of 2025. The Phase 3 ALKAZAR trial will be a global, randomized, controlled trial designed to evaluate neladalkib versus the current standard of care for the treatment of patients with TKI-naïve ALK-positive NSCLC. Patients will be randomized 1:1 to receive neladalkib monotherapy or ALECENSA (alectinib) monotherapy, reflecting input from collaborating physician-scientists and alignment with the FDA.
HER2 Program

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Enrollment is ongoing in the HEROEX-1 Phase 1a/1b clinical trial evaluating the overall safety and tolerability of NVL-330 for pre-treated patients with HER2-altered NSCLC. Additional objectives include determination of the recommended Phase 2 dose, characterization of NVL-330’s pharmacokinetic profile, and preliminary evaluation of anti-tumor activity. The company expects to continue to progress the HEROEX-1 trial throughout 2025.
Business Updates

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Appointed Grant Bogle to Board of Directors: As previously announced, Nuvalent appointed Grant Bogle to its board of directors in December 2024. Mr. Bogle brings nearly four decades of proven leadership in building and growing biotechnology companies to the Nuvalent board. Throughout his career, he has served in senior leadership roles at several specialty pharmaceutical and biotechnology companies and worked alongside oncologists as part of the leadership of U.S. Oncology, the largest network of community oncology practices in the United States. He has a proven track record of success in the field of oncology and has guided numerous products from early-stage development to commercialization. Most recently, Mr. Bogle was the Chief Executive Officer at Epizyme, Inc., and oversaw the 2022 acquisition of the company by Ipsen. Prior to that, Mr. Bogle was Senior Vice President and Chief Commercial Officer of TESARO, which was acquired by GlaxoSmithKline in 2018. Earlier, he served as Senior Vice President of Pharmaceutical and Biotech Solutions at McKesson Specialty Health (formerly U.S. Oncology).
Fourth Quarter and Full Year 2024 Financial Results

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Cash Position: Cash, cash equivalents and marketable securities were $1.1 billion as of December 31, 2024. Nuvalent continues to believe that its existing cash, cash equivalents and marketable securities will be sufficient to fund its current operating plan into 2028.
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R&D Expenses: Research and development (R&D) expenses were $69.4 million for the fourth quarter of 2024 and $217.8 million for the year ended December 31, 2024.
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G&A Expenses: General and administrative (G&A) expenses were $16.9 million for the fourth quarter of 2024 and $62.6 million for the year ended December 31, 2024.
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Net Loss: Net loss was $74.8 million for the fourth quarter of 2024 and $260.8 million for the year ended December 31, 2024.

On February 27, 2025 AbCellera (Nasdaq: ABCL) reported financial results for the full year 2024. All financial information in this press release is reported in U.S. dollars, unless otherwise indicated (Press release, AbCellera, FEB 27, 2025, View Source [SID1234650733]).

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"In 2024 we made significant progress in transitioning from a platform company to a clinical-stage biotech, including advancing our internal pipeline and completing significant investments in our capabilities. We also maintained our strong cash position, closing the year with over $800 million in available liquidity to execute on our strategy," said Carl Hansen, Ph.D., founder and CEO of AbCellera. "As a result, we enter 2025 on track to initiate Phase 1 clinical trials for our first two programs, ABCL635 and ABCL575, and to start activities in our new clinical manufacturing facility."

FY 2024 Business Summary

Earned $28.8 million in total revenue.
Generated a net loss of $162.9 million, compared to net loss of $146.4 million in 2023.
Reached a cumulative total of 96 partner-initiated program starts with downstreams.
Reporting the advancement of three additional molecules in the clinic, bringing the cumulative total to 16 molecules to have reached the clinic.
Key Business Metrics

Cumulative Metrics

December 31, 2023

December 31, 2024

Change %

Partner-initiated program starts with downstreams

87

96

10

%

Molecules in the clinic

13

16

23

%

AbCellera started discovery on an additional nine partner-initiated programs with downstreams to reach a cumulative total of 96 partner-initiated program starts with downstreams in 2024 (up from 87 on December 31, 2023). AbCellera’s partners have advanced a cumulative total of 16 molecules into the clinic (up from 13 on December 31, 2023).

Discussion of FY 2024 Financial Results

Revenue – Total revenue was $28.8 million, compared to $38.0 million in 2023. In both periods, the majority of revenues were research fees generated by our partnerships.
Research & Development (R&D) Expenses – R&D expenses were $167.3 million, compared to $175.7 million in 2023, reflecting underlying continued growth in program execution, platform development, and investments in internal programs.
Sales & Marketing (S&M) Expenses – S&M expenses were $12.8 million, compared to $14.2 million in 2023.
General & Administrative (G&A) Expenses – G&A expenses were $72.7 million, compared to $61.0 million in 2023.
Net Loss – Net loss of $162.9 million, or $(0.55) per share on a basic and diluted basis, compared to net loss of $146.4 million, or $(0.51) per share on a basic and diluted basis, in 2023.
Liquidity – $652.9 million of total cash, cash equivalents, and marketable securities and approximately $186 million in available non-dilutive government funding, bringing total available liquidity to approximately $840 million to execute on AbCellera’s strategy.
Q4 Highlights and Financial Results

Abdera advanced ABD-147 into a Phase 1 clinical trial. AbCellera is a founding partner in Abdera, has a low-single-digit royalty stake in Abdera’s programs, and has a mid-single-digit equity ownership position.
Reporting the advancement of two Trianni-license molecules into the clinic.
Started one partner-initiated program with downstreams.
Revenue for the fourth quarter of 2024 was $5.1 million, the majority of which was research fees generated by our partnerships, representing 18% of total revenue for 2024.
Operating expenses totaled $77.8 million in the fourth quarter, or 23% of the total for 2024, and included investments made in co-development and internal programs.
The net loss for the fourth quarter was $34.2 million, or $(0.12) per share, on a basic and diluted basis.
Conference Call and Webcast

AbCellera will host a conference call and live webcast to discuss these results today at 2:00 p.m. Pacific Time (5:00 p.m. Eastern Time).

The live webcast of the earnings conference call can be accessed on the Events and Presentations section of AbCellera’s Investor Relations website. A replay of the webcast will be available through the same link following the conference call.

On February 27, 2025 Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel therapies across a range of cancers, reported financial results for the fourth quarter and full year ended December 31, 2024, and provided a business update (Press release, Cardiff Oncology, FEB 27, 2025, View Source [SID1234650690]).

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"2024 was a significant year for Cardiff Oncology as we shared positive data from the first 30 patients in our lead program in first-line RAS-mut mCRC," said Mark Erlander, Ph.D., Chief Executive Officer of Cardiff Oncology. "We were excited to report that patients on the 30mg onvansertib dose arm demonstrated a 64% response rate, compared to a 33% response rate in the control arm. In the experimental arm, we observed a dose response relationship with the 30mg dose of onvansertib demonstrating increased ORR and deeper tumor regression compared to the 20mg dose of onvansertib with similar safety profiles for both doses. We believe this correlation between the dose of onvansertib and the magnitude of therapeutic effect serves as validation that onvansertib is a biologically active drug for the treatment of cancer, which we believe may translate to additional oncology indications in our pipeline. In addition to the robust efficacy signal in the CRDF-004 trial, these data suggest that onvansertib could safely be combined with both standard of care first-line chemotherapy options for mCRC in the U.S. With our balance sheet strengthened by a $40M investment from biotech specialist investors, we now look forward to sharing additional clinical updates from CRDF-004 in H1 2025."

Upcoming expected milestones

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Additional clinical data from CRDF-004 trial expected in 1H 2025

Company highlights for the quarter ended December 31, 2024, and subsequent weeks include:

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Announced positive initial data from ongoing first-line RAS-mutated mCRC clinical trial (CRDF-004)
▪
Phase 2 trial is currently enrolling patients with mCRC who have a documented KRAS or NRAS mutation. Onvansertib is added to standard-of-care (SoC) consisting of FOLFIRI plus bevacizumab ("bev") or FOLFOX plus bev. Patients will be randomized to either 20mg of onvansertib plus SoC, 30mg of onvansertib plus SoC, or SoC alone.
▪
Patients on the 30mg onvansertib dose arm demonstrated 64% objective response rate (ORR) versus 33% ORR in the control arm.
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The 30mg dose of onvansertib demonstrated a higher ORR and deeper tumor regression compared to the 20mg dose of onvansertib (64% vs. 50%)
▪
Onvansertib was well tolerated at both doses.

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Raised $40 million in an oversubscribed underwritten registered direct offering
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The financing included participation from new and existing healthcare dedicated investors.
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Patent issuance from the United States Patent and Trademark Office (USPTO)
▪
U.S. patent No. 12,144,813 has an expected expiration date of no earlier than 2043. The patent claims cover the method of using onvansertib in combination with bev for the treatment of KRAS mutated mCRC patients who have not previously been treated with bev ("bev naïve"). This patent is supported by the unexpected benefits of the treatment in such bev naïve patients.
•
Presented two posters at the San Antonio Breast Cancer Symposium
▪
Onvansertib demonstrated synergy in combination with paclitaxel in hormone receptor positive (HR+) breast cancer cell lines and robust antitumor activity in patient-derived xenograft (PDX) models resistant to first-line therapies. These data support that onvansertib in combination with paclitaxel represents a promising therapeutic strategy for HR+ breast cancer patients after progression on endocrine therapy and CDK4/6 inhibitors. A phase 1b/2 clinical trial is ongoing to evaluate the safety and efficacy of onvansertib in combination with paclitaxel in advanced triple negative breast cancer (NCT05383196).
▪
Onvansertib in combination with trastuzumab deruxtecan (T-DXd) was well tolerated, overcame T-DXd resistance, and displayed enhanced anti-tumor activity compared to monotherapies in drug resistant HR+ breast cancer patient derived xenograft (PDX) models. The combination of T-DXd with onvansertib represents a promising therapeutic strategy for HR+ breast cancer patients resistant to first-line therapies.
•
Published clinical data of the combination of onvansertib with FOLFIRI and bev in second-line KRAS mutant mCRC in the peer-reviewed Journal of Clinical Oncology, the flagship publication of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)
▪
Phase 2 clinical trial treating patients with KRAS-mutant mCRC (NCT03829410) demonstrated that onvansertib combined with FOLFIRI and bev was well-tolerated and exhibited clinical activity in the second-line setting.
▪
A post hoc analysis revealed a greater clinical benefit in bev naïve patients, who demonstrated an ORR of 77% and mPFS of 14.9 months compared to an ORR of 10% and mPFS of 6.6 months in those previously exposed to bev.

Full Year 2024 Financial Results:

Liquidity, cash burn, and cash runway

As of December 31, 2024, Cardiff Oncology had approximately $91.7 million in cash, cash equivalents, and short-term investments.

Net cash used in operating activities for the full year 2024 was approximately $37.7 million, an increase of approximately $6.8 million from $30.9 million for the same period in 2023.

Based on its current expectations and projections, the Company believes its current cash resources are sufficient to fund its operations into Q1 2027.

Operating results

Total operating expenses were approximately $49.3 million for the full year ended December 31, 2024, an increase of $3.4 million from $45.9 million for the same period in 2023. The increase in operating expenses was primarily due to costs associated with clinical programs and outside service costs related to the development of our lead drug candidate, onvansertib, and higher salaries and staff costs primarily due to increased headcount and stock-based compensation for additional grants to employees.

Conference Call and Webcast

Cardiff Oncology will host a corresponding conference call and live webcast today at 4:30 p.m. ET/1:30 p.m. PT. Individuals interested in listening to the live conference call may do so by using the webcast link in the "Investors" section of the company’s website at www.cardiffoncology.com. A webcast replay will be available in the investor relations section on the company’s website following the completion of the call.

On February 27, 2025 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, reported financial results for the fourth quarter and year ended December 31, 2024, and provided a business update (Press release, AnaptysBio, FEB 27, 2025, View Source [SID1234650715]).

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"Rosnilimab’s positive Phase 2b data in rheumatoid arthritis has revealed impressive safety, tolerability and three-month efficacy data that was sustained and surpasses six-month data from competitor all-active, head-to-head trials. In Q2 2025, we will report full clinical and translational data, further validating rosnilimab’s transformative potential to restore immune homeostasis, not only in RA but also in other diseases like ulcerative colitis. We also are excited to report top-line Phase 2 data for rosnilimab in UC moved up to Q4 2025," said Daniel Faga, president and chief executive officer of Anaptys. "Additionally, Phase 1 development of both ANB033 and ANB101 is advancing as planned. With approximately $420 million of cash coming into 2025, we are well capitalized through year-end 2027, which does not include the significant potential residual royalties and milestones from our GSK financial collaboration."
Updates on Asset Portfolio

Rosnilimab (PD-1 depleter and agonist)
•Announced subcutaneously administered rosnilimab, including two once-monthly doses, achieved positive results in 424-patient Phase 2b RA trial and highest-ever reported clinical disease activity index (CDAI) low disease activity (LDA) response over 6 months
◦Key results for the trial were –
▪Achieved statistical significance on primary endpoint at Week 12 on mean change from baseline DAS28-CRP score across all three rosnilimab doses vs. placebo
▪Achieved statistical significance on key secondary endpoints at Week 12 on ACR20, ACR50 and CDAI LDA
▪Demonstrated highest-ever reported responses on key secondary endpoints at Week 14 on ACR20, ACR50, ACR70 and CDAI LDA
▪69% (220/318) of rosnilimab-treated patients achieved CDAI LDA at Week 14 and appear to show sustained CDAI LDA and ACR50 responses and potentially deepening ACR70 responses out to Week 28
▪Robust pharmacological activity observed in reduction of PD-1high T cells, increase in total Tregs and reduction of CRP across all doses
▪Rosnilimab was safe and well tolerated with similar adverse event rates vs. placebo

◦Full clinical and translational data anticipated in Q2 2025
•Enrollment ongoing for global Phase 2 trial in moderate-to-severe UC
◦132-patient trial assessing two dose levels of subcutaneously administered rosnilimab vs. placebo (randomized 1:1:1)
▪Primary statistical analysis at Week 12 on well-established endpoints, including the primary endpoint of change from baseline in modified Mayo score (mMS) and supportive secondary endpoints of clinical response on mMS, clinical remission on mMS and endoscopic remission
▪All patients in all three study arms treat-through to Week 24 and remain blinded to treatment arm. Placebo-treated patients who achieved clinical response on partial modified Mayo score (pmMS) at Week 12 remain on placebo, while placebo-treated patients who are non-responders are crossed over to the high-dose rosnilimab treatment arm
▪Patients who are in clinical response on pmMS at Week 24 are eligible for an additional 26-weeks (50 weeks of total treatment), blinded treatment extension period (TEP)
◦Top-line data anticipated in Q4 2025
•Presented preclinical data in Q4 2024 and Q1 2025 (available at View Source) evaluating –
◦The PD-1 depletion and agonism mechanisms of rosnilimab in vitro with UC patient-derived PBMCs and a mouse model of colitis at the 2024 United European Gastroenterology Week (UEGW)
◦Inflammatory pathway gene expression in PD-1+ conventional and regulatory T cells in human UC tissue and rosnilimab’s effects in a mouse model of colitis at the European Crohn’s and Colitis Organisation (ECCO) Congress
◦Synovial levels of PD-1 and the correlation with disease activity in RA at American College of Rheumatology (ACR) Convergence
ANB033 (CD122 antagonist)
•Enrollment ongoing for Phase 1a trial in healthy volunteers
◦Phase 1b indication to be disclosed at a 2025 R&D event
ANB101 (BDCA2 modulator)
•Investigational new drug (IND) application accepted by FDA
•Phase 1a trial to initiate in healthy volunteers in Q1 2025
Imsidolimab (IL-36 antagonist)
•Announced an exclusive global out-license agreement with Vanda Pharmaceuticals to develop and commercialize imsidolimab (IL-36R antagonist)
◦Anaptys received $15 million, comprised of a $10 million upfront payment and $5 million for existing drug supply
◦Anaptys eligible to receive up to $35 million for future regulatory approvals and sales milestones in addition to a 10% royalty on global net sales
GSK Immuno-Oncology Financial Collaboration
•GSK announced strong commercial performance for Jemperli ($190 million in Q4 2024 sales) with >100% year-over-year growth
•GSK anticipates top-line data in H1 2025 from COSTAR Lung Phase 3 trial comparing cobolimab, a TIM-3 antagonist, plus dostarlimab, a PD-1 antagonist, plus docetaxel to dostarlimab plus docetaxel and to docetaxel alone in patients with advanced NSCLC who have progressed on prior anti-PD-(L)1 therapy and platinum-based chemotherapy

•GSK anticipates top-line data in 2026 from AZUR-1 pivotal Phase 2 trial of dostarlimab monotherapy in patients with untreated stage II/III dMMR/MSI-H locally advanced rectal cancer
◦Jemperli received U.S. FDA Breakthrough Therapy Designation for this indication in December 2024
Cash Runway
•Cash and investments of $420.8 million as of Dec. 31, 2024, and reiterating cash runway through year-end 2027
Fourth Quarter and Full Year 2024 Financial Results
•Cash, cash equivalents and investments totaled $420.8 million as of December 31, 2024, compared to $417.9 million as of December 31, 2023, for an increase of $2.9 million due primarily to the $100 million underwritten registered direct offering completed in Q3 and $50.0 million received from the Sagard royalty monetization in Q2 offset by 2024 operating activities.
•Collaboration revenue was $43.1 million and $91.3 million for the three and twelve months ended December 31, 2024, compared to $9.0 million and $17.2 million for the three and twelve months ended December 31, 2023. The increase in non-cash revenue in 2024 is due to $15.0 million and $25.0 million commercial milestones earned for annual Jemperli sales exceeding $250.0 million and $500.0 million during the year and increased royalties recognized for sales of Jemperli. For the year ended December 31, 2024, GSK reported $598.0 million in sales for Jemperli, a greater than 200% sales growth when compared to $175.6 million for the year ended December 31, 2023.
•Research and development expenses were $42.6 million and $163.8 million for the three and twelve months ended December 31, 2024, compared to $33.5 million and $132.3 million for the three and twelve months ended December 31, 2023. The increase was due primarily to development costs for rosnilimab, ANB032, ANB033 and ANB101 offset by a decrease in development costs for imsidolimab. The R&D non-cash, stock-based compensation expense was $3.9 million and $14.8 million for the three and twelve months ended December 31, 2024 as compared to $2.5 million and $10.2 million in the same period in 2023.
•General and administrative expenses were $10.2 million and $42.4 million for the three and twelve months ended December 31, 2024, compared to $10.3 million and $41.9 million for the three and twelve months ended December 31, 2023. The G&A non-cash, stock-based compensation expense was $4.3 million and $19.2 million for the three and twelve months ended December 31, 2024 as compared to $5.6 million and $23.0 million in the same period in 2023.
•Net loss was $21.8 million and $145.2 million for the three and twelve months ended December 31, 2024, or a net loss per share of $0.72 and $5.12, compared to a net loss of $42.2 million and $163.6 million for the three and twelve months ended December 31, 2023, or a net loss per share of $1.59 and $6.08.
▪Full press release can be found at View Source

On February 27, 2025 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported its financial results for the fourth quarter and year ended December 31, 2024 (Press release, Castle Biosciences, FEB 27, 2025, View Source [SID1234650689]).

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"Castle delivered an outstanding fourth quarter that rounded out an exceptional 2024, including 51% revenue growth and 36% test report volume growth compared to 2023," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "I am incredibly proud of our team’s hard work in achieving these results, including achieving our previously provided 2025 revenue guidance range one year ahead of expectations.

"We are extremely pleased with the progress we made across our initiatives in 2024 in the areas of our core growth drivers, including a 17% increase in our dermatologic test reports (DecisionDx-Melanoma and DecisionDx-SCC combined) and a 130% increase in our TissueCypher Barrett’s Esophagus test reports, over 2023. We believe this was driven largely by the clinical value of our tests, strong execution on our commercial strategy and expansion of our clinical evidence base.

"Building on our momentum and successes, we expect to continue to focus on delivering operational excellence. Further, sound capital allocation remains a priority, including pursuing strategic opportunities, aimed at driving stockholder value in 2025 and beyond."

Twelve Months Ended December 31, 2024, Financial and Operational Highlights
•Revenues were $332.1 million, a 51% increase compared to $219.8 million in 2023.
•Adjusted Revenues, which exclude the effects of revenue adjustments related to tests delivered in prior periods, were $333.8 million, a 49% increase compared to $224.3 million in 2023.
•Delivered 96,071 total test reports in 2024, an increase of 36% compared to 70,429 in 2023:
◦DecisionDx-Melanoma test reports delivered in 2024 were 36,008, compared to 33,330 in 2023.
◦DecisionDx-SCC test reports delivered in 2024 were 16,348, compared to 11,442 in 2023.
◦MyPath Melanoma test reports delivered in 2024 were 3,909, compared to 3,962 MyPath Melanoma and DiffDx-Melanoma aggregate test reports in 2023.
◦TissueCypher Barrett’s Esophagus test reports delivered in 2024 were 20,956, compared to 9,100 in 2023.
◦IDgenetix test reports delivered in 2024 were 17,151, compared to 10,921 in 2023.
◦DecisionDx-UM test reports delivered in 2024 were 1,699, compared to 1,674 in 2023.
•Gross margin for 2024 was 79%, and Adjusted Gross Margin was 82%, compared to 75% and 80% respectively for the same periods in 2023.
•Net cash provided by operations was $64.9 million, compared to net cash used in operations of $5.6 million in 2023.

•Net income for 2024, which includes non-cash stock-based compensation expense of $50.3 million, was $18.2 million, compared to a net loss of $57.5 million in 2023.
•Adjusted EBITDA for 2024 was $75.0 million, compared to $(4.4) million in 2023.
Cash, Cash Equivalents and Marketable Investment Securities
As of December 31, 2024, the Company’s cash, cash equivalents and marketable investment securities totaled $293.1 million.
Fourth Quarter Ended December 31, 2024, Financial and Operational Highlights
•Revenues were $86.3 million, a 31% increase compared to $66.1 million during the same period in 2023.
•Adjusted Revenues, which exclude the effects of revenue adjustments related to tests delivered in prior periods, were $85.8 million, a 22% increase compared to $70.2 million for the same period in 2023.
•Delivered 24,071 total test reports, an increase of 19% compared to 20,284 in the same period of 2023:
◦DecisionDx-Melanoma test reports delivered in the quarter were 8,672, compared to 8,591 in the fourth quarter of 2023.
◦DecisionDx-SCC test reports delivered in the quarter were 4,299, compared to 3,530 in the fourth quarter of 2023.
◦MyPath Melanoma test reports delivered in the quarter were 879, compared to 1,018 in the fourth quarter of 2023.
◦TissueCypher Barrett’s Esophagus test reports delivered in the quarter were 6,672, compared to 3,441 in the fourth quarter of 2023.
◦IDgenetix test reports delivered in the quarter were 3,125, compared to 3,299 in the fourth quarter of 2023. In late 2024, the Company made modifications to its promotional investments for IDgenetix, shifting resources to inside sales and non-personal promotion.
◦DecisionDx-UM test reports delivered in the quarter were 424, compared to 405 in the fourth quarter of 2023.
•Gross margin was 76%, and Adjusted Gross Margin was 81%, compared to 78% and 82% respectively for the same periods in 2023.
•Net cash provided by operations was $24.4 million, compared to $18.6 million for the same period in 2023.
•Net income, which includes non-cash stock-based compensation expense of $11.4 million, was $9.6 million, compared to a net loss of $2.6 million for the same period in 2023.
•Adjusted EBITDA was $21.3 million, compared to $9.4 million for the same period in 2023.
2025 Outlook
The Company anticipates generating between $280-295 million in total revenue in 2025.
Fourth Quarter and Recent Accomplishments and Highlights
Dermatology
•DecisionDx-Melanoma: Findings from a prospective, multicenter study demonstrating the significant impact of the DecisionDx-Melanoma test on sentinel lymph node biopsy (SLNB) decision-making for patients with melanoma were recently published in the World Journal of Surgical Oncology; further; no patient with a DecisionDx-Melanoma-predicted risk of SLN positivity of less than 5% who decided to have an SLNB procedure had a positive node.
•DecisionDx-Melanoma: The Company announced the publication of a new independent meta-analysis in Cancers assessing the efficacy of its DecisionDx-Melanoma test in predicting melanoma patient outcomes. The article, titled "The Prognostic Value of the 31-Gene Expression Profile Test in Cutaneous Melanoma: A Systematic Review and Meta-Analysis," concluded that DecisionDx-Melanoma consistently provides improved risk stratification over staging alone to inform personalized management strategies for patients with cutaneous melanoma (CM). This recently published meta-analysis encompassed 13 peer-reviewed publications involving thousands of patients and affirmed the powerful risk stratification provided by DecisionDx-Melanoma and its potential to significantly improve care for patients with CM. See the Company’s news release from Dec. 12, 2024, for more information.

•DecisionDx-Melanoma: The Company announced the latest data from a prospective, multicenter study exploring the impact of integrating DecisionDx-Melanoma test results into SLNB decision-making for patients recently diagnosed with melanoma. The updated findings demonstrated the power of the test’s results to accurately identify patients with a low risk of metastasis who can safely forgo SLNB, thereby reducing unnecessary SLNB procedures and the associated costs and risks of complications that accompany them. The data was presented in a poster and oral presentation at The European Congress on Dermato-Oncology (Dermato-Onco2024) recently held in Vienna, Austria. See the Company’s news release from Nov. 6, 2024, for more information.
•DecisionDx-SCC: The Company announced that its poster on DecisionDx-SCC was selected as a "Late Breakers" top five finalist for the Akamai Award, recognizing the best posters at Maui Derm Hawaii 2025. Specifically, the poster shared new data from a study involving Castle’s largest cohort of patients with cutaneous squamous cell carcinoma (SCC) to date (n=1,408). This study demonstrated improved risk stratification of patients with SCC tumors located on the head or neck when the test’s results are combined with Brigham and Women’s Hospital (BWH) staging. See the Company’s news release from Jan. 17, 2025, for more information.
Gastroenterology
•The Company announced that it received assay approval from the New York State Department of Health (NYSDOH) for its TissueCypher Barrett’s Esophagus (BE) test. With this approval, all of the tests in Castle’s dermatology, gastroenterology and ophthalmology portfolios, as well as its clinical laboratories in Phoenix and Pittsburgh, are now approved by the state of New York. See the Company’s news release from Jan. 6, 2025, for more information.
Corporate
•The Company announced that it was named a Houston Top Workplace for 2024 by the Houston Chronicle. This was the fourth consecutive year the Company was ranked among the Houston metro area’s top workplaces. Castle also earned three Culture Excellence awards in the areas of Employee Appreciation, Employee Well-Being and Professional Development. See the Company’s news release from Nov. 19, 2024, for more information.
Conference Call and Webcast Details
Castle Biosciences will hold a conference call on Thursday, Feb. 27, 2025, at 4:30 p.m. Eastern time to discuss its fourth quarter and full-year 2024 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 March 20, 2025.

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 944585.

There will be a brief Question & Answer session following management commentary.