On November 3, 2025 Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, reported positive results from its ongoing ANTLER phase 1 clinical trial evaluating vispacabtagene regedleucel (vispa-cel; formerly CB-010), an allogeneic anti-CD19 CAR-T cell therapy, in patients with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL).

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"The ANTLER data mark an exciting advancement for the field of cellular immunotherapy," said Mehdi Hamadani, MD, professor of medicine and section chief of hematologic malignancies at the Medical College of Wisconsin and an investigator on the ANTLER trial. "This clinical dataset demonstrates vispa-cel’s efficacy and durability are comparable to autologous CAR-T therapies, yet its off-the-shelf availability and favorable tolerability profile make it well suited for outpatient administration at both large academic centers and sophisticated community hospitals. This combination of robust clinical activity and accessibility could significantly broaden patient access to transformative CAR-T cell treatments, particularly for those who cannot wait or are ineligible for transplantation or autologous CAR-T cell therapies."

As of the September 2, 2025, safety data cutoff date, the ANTLER trial has enrolled 84 patients, including a confirmatory cohort of 22 CD19-naïve second-line (2L) large B cell lymphoma (LBCL) patients. The confirmatory cohort was designed to prospectively confirm the positive outcomes of partial HLA matching (≥4 matched HLA alleles) observed in earlier retrospective analyses. Patients in the confirmatory cohort received vispa-cel at the recommended phase 2 dose (RP2D; 80×10⁶ CAR-T cells), and the data from this cohort, as of an efficacy data cutoff date of September 29, 2025, confirmed that a single dose of partially matched (≥4 matched HLA alleles) vispa-cel results in efficacy that is on par with approved autologous CAR-T cell therapies including an 82% overall response rate (ORR), a 64% complete response (CR) rate, and 51% progression-free survival (PFS) at 12 months (Table 1). Median follow-up for the confirmatory cohort is 6.0 months.

Table 1. ANTLER phase 1 trial endpoints
Endpoints
Confirmatory cohort1
N=22
Optimized profile2
N=35
ORR
82%
86%
CR rate
64%
63%
Median PFS
(95% CI)
NR
(2.0, NE)
NR
(2.8, NE)
12-month PFS
(95% CI)
51%
(28, 70)
53%
(34, 69)
Median DoR
(95% CI)
NR
(1.7, NE)
NR
(2.1, NE)

12L LBCL 4+ HLA matched, dosed with 80M vispa-cel CAR-T cells
22L (N=32) and 3L+ (N=3) LBCL patients treated with 40M, 80M, or 120M vispa-cel CAR-T cells optimized for multiple factors, including 2+ HLA matching and young donor-derived
CR: complete response; DoR: duration of response; HLA: human leukocyte antigen; NE: not evaluable; NR: not reached; ORR: overall response rate; PFS: progression-free survival
Data cutoff date for efficacy: September 29, 2025

The Company leveraged its large allogeneic CAR-T cell clinical data set (>140 patients dosed across multiple clinical trials) to identify key factors linked to successful patient outcomes. Two of those factors are donor age (young donors drive enhanced outcomes relative to older donors) and partial HLA matching (matching 2 or more [2+] alleles correlates with outcomes on par with autologous CAR-T cell therapies). Of the 84 patients dosed with vispa-cel, there are 35 CD19-naïve LBCL patients who received vispa-cel with an optimized profile (32 of these patients were 2L and 3 of these patients were 3L+). The optimized profile vispa-cel was manufactured from young donor-derived T cells, and the 35 patients matched a minimum of 2 HLA alleles with the T cell donor. Twenty of the 35 patients in the optimized profile cohort were enrolled in the confirmatory cohort, and the remaining 15 patients were enrolled in dose escalation or expansion.

Data from this 35-patient cohort further confirmed that the efficacy and durability of vispa-cel are on par with the autologous CAR-T cell therapies. Median follow-up for the optimized profile cohort was 11.8 months, and the longest responding patient, who completed the 2-year ANTLER trial and enrolled in the long-term follow-up study, is in complete response at 3 years post infusion. As of the September 29, 2025, efficacy data cutoff date, the results for the 35-patient optimized profile cohort included an 86% ORR, a 63% CR rate, and 53% PFS at 12 months (Table 1).

In all patients treated in ANTLER (N=84), vispa-cel has demonstrated a generally well-tolerated safety profile. As of the September 2, 2025, safety data cutoff date, treatment emergent adverse events at any grade in ≥25% of all patients who received vispa-cel were thrombocytopenia (62%), cytokine release syndrome (CRS; 55%), anemia (52%), neutropenia (39%), hypokalemia (26%), and leukopenia (26%). In the confirmatory and optimized profile cohorts, there were no cases of graft-versus-host disease (GvHD) or ≥grade 3 immune effector cell-associated neurotoxicity syndrome (ICANS), <5% patients experienced ≥grade 3 CRS, and there were manageable rates of infections and prolonged cytopenias (Table 2). The safety profile of vispa-cel allows for use in an outpatient setting.

"We believe that with these results, Caribou has achieved what the field has long sought — strong evidence that an allogeneic CAR-T cell therapy can be on par with the efficacy and durability of autologous treatments and broaden access with a safety profile that allows for outpatient use," said Rachel Haurwitz, PhD, Caribou’s president and CEO. "This milestone positions vispa-cel as a potentially best-in-class allogeneic CAR-T cell therapy for patients with large B cell lymphoma. We believe we have a straightforward regulatory path toward full registration by following the FDA’s recommendation for a randomized, controlled phase 3 trial in second-line large B cell lymphoma, and we plan to refine our pivotal trial design in the coming months through continued engagement with the FDA."

Table 2. ANTLER phase 1 trial safety data
Events, n (%)
All treated
N=84
Confirmatory cohort
N=221
Optimized profile
N=352
All grade
≥Grade 3
All grade
≥Grade 3
All grade
≥Grade 3
ICANS
12 (14)
4 (5)
1 (5)
0 (0)
1 (3)
0 (0)
CRS
46 (55)
1 (1)
13 (59)
1 (5)
19 (54)
1 (3)
Infections
43 (51)
21 (25)
9 (41)
4 (18)
20 (57)
6 (17)
Prolonged cytopenias3
NA
22/80 (28)
NA
5/19 (26)
NA
7/32 (22)
IEC-HS4
2 (2)
2 (2)
1 (5)
1 (5)
1 (3)
1 (3)

12L LBCL 4+ HLA matched, dosed with 80M vispa-cel CAR-T cells
22L (N=32) and 3L+ (N=3) LBCL patients treated with 40M, 80M, or 120M vispa-cel CAR-T cells optimized for multiple factors, including 2+ HLA matching and young donor-derived
3Prolonged cytopenias are defined as Grade 3 or 4 neutropenia, thrombocytopenia, or anemia ongoing at day 28 (+/- 5 days) post CAR-infusion, based on laboratory data, distinct from investigator-reported clinical adverse events.
4Includes one vispa-cel-related grade 5 IEC-HS that occurred on day 25 post-infusion.
CRS: cytokine release syndrome; IEC-HS: immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome; NA: not applicable
Data cutoff date for safety: September 2, 2025

A cohort of third-line or later LBCL patients with prior exposure to CD19-targeted therapy enrolled 5 patients as of the September 2, 2025, safety data cutoff date. Enrollment in this cohort has been paused to focus on CD19-naïve patients.

Pivotal phase 3 trial for 2L LBCL for full approval
In recent interactions, the FDA has recommended the Company conduct a randomized, controlled trial in 2L LBCL CD19-naive patients who are ineligible for transplant and autologous CAR-T cell therapy, and the Company intends to follow this approach with its planned pivotal phase 3 clinical trial design, evaluating approximately 250 patients. Patients randomized to the study arm would receive a single dose of vispa-cel at the recommended phase 2 dose of 80×10⁶ CAR-T cells following lymphodepletion with cyclophosphamide and fludarabine, and patients randomized to the comparator arm would be treated with the investigator’s choice of standard of care immunochemotherapy agents. The primary endpoint is PFS, and an interim analysis of PFS is planned. Secondary endpoints would include ORR, complete response rate (CRR), duration of response (DoR), duration of complete response (DoCR), overall survival (OS), quality of life (QoL), and safety. This expected trial design reflects Caribou’s internal analysis and interactions with the FDA to date. The Company intends to further refine the pivotal trial design through continued engagement with the FDA prior to initiation. Caribou plans to bring vispa-cel closer to where patients live by leveraging community and academic sites within the U.S. and globally.

Webcast conference call today at 8:00 am ET
Caribou will host a live conference call and webcast on Monday, November 3 at 8:00 am ET to discuss the ANTLER trial data and the pivotal phase 3 clinical trial design, as well as the CaMMouflage phase 1 clinical trial for r/r multiple myeloma. The presenters will include:
•Mehdi Hamadani, MD, professor of medicine, section chief of hematologic malignancies at Medical College of Wisconsin, and investigator on the ANTLER trial
•Joseph McGuirk, DO, professor of hematology/oncology and division director for hematologic malignancies and cellular therapeutics at University of Kansas Cancer Center
•Adriana Rossi, MD, director of CAR-T and stem cell transplant clinical program at the center of excellence for multiple myeloma at Mt Sinai, and investigator on the CaMMouflage trial
•Rachel Haurwitz, PhD, president and chief executive officer, Caribou Biosciences
•Tina Albertson, MD, PhD, chief medical officer, Caribou Biosciences

A live webcast of the presentation will be accessible via Caribou’s website on the Events page. The archived webcast will be available on the Caribou website for 30 days after the event.

About vispacabtagene regedleucel
Vispacabtagene regedleucel (vispa-cel; formerly known as CB-010) is an allogeneic anti-CD19 CAR-T cell therapy being evaluated in patients with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL). To Caribou’s knowledge, vispa-cel is the first allogeneic CAR-T cell therapy in the clinic with a PD-1 knockout, a genome-editing strategy designed to enhance CAR-T cell activity by limiting premature CAR-T cell exhaustion. The FDA granted vispa-cel Regenerative Medicine Advanced Therapy (RMAT), Orphan Drug, and Fast Track designations for B-NHL.

About the ANTLER phase 1 clinical trial
The ANTLER clinical trial is a multicenter, open-label phase 1 trial evaluating vispacabtagene regedleucel (vispa-cel; formerly CB-010) in adults with relapsed or refractory B cell non-Hodgkin lymphoma (B-NHL). Eighty-four patients have been treated in the ANTLER clinical trial as of September 2, 2025. Using a 3+3 enrollment strategy, safety and efficacy were assessed in 16 patients in dose escalation evaluating 40×106, 80×106, and 120×106 CAR-T cell dose levels with a lymphodepletion regimen of cyclophosphamide at 60 mg/kg/day for 2 days followed by fludarabine at 25 mg/m2/day for 5 days. Forty-one patients with 2L LBCL were enrolled in the dose expansion portion, and 80×106 CAR-T cells was selected as the recommended phase 2 dose (RP2D). An additional 22 patients with 2L LBCL were enrolled in the confirmatory cohort, which prospectively evaluated the Company’s partial HLA matching strategy. Five patients were enrolled in a cohort of third-line or later LBCL patients with prior exposure to CD19-targeted therapy. Additional information on the ANTLER trial (NCT04637763) can be found at clinicaltrials.gov.

(Press release, Caribou Biosciences, NOV 3, 2025, View Source [SID1234659245])

On November 3, 2025 INOVIO (NASDAQ: INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, reported that it has completed the rolling submission of its Biologics License Application (BLA) for its DNA immunotherapy candidate INO-3107 for the treatment of RRP in adults.

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INOVIO submitted the BLA under the FDA’s Accelerated Approval program and has requested a priority review, which if granted, is expected to be completed within six months following the 60-day filing period. If approved, INO-3107 would be INOVIO’s first commercial product and the first DNA medicine available in the United States.

"The potential to have a meaningful new treatment for RRP brings me so much hope for the RRP community, which has been desperate for relief from the risks and costs of repeated surgery," said Kim McClellan, President of the RRP Foundation. "Every patient deserves a therapy that works for them and I believe we are now one step closer to surgery being a last resort for the treatment of this disease."

"This is a pivotal moment in our efforts to deliver on the promise of INO-3107, an innovative DNA immunotherapy candidate that has the potential to become a paradigm-shifting treatment option for RRP," said Dr. Michael Sumner, Chief Medical Officer of INOVIO. "I’d like to thank the patients and physicians who participated in the INO-3107 clinical trial, as well as our internal team for their tremendous effort in completing INOVIO’s first BLA submission. We look forward to continued communication and collaboration with the FDA during the review process and will be focused on finalizing our preparations for a potential commercial launch in 2026."

About RRP
RRP is a debilitating and rare disease caused primarily by HPV-6 and/or HPV-11. RRP is characterized by the development of small, wart-like growths, or papillomas, in the respiratory tract. While papillomas are generally benign, they can cause severe, life-threatening airway obstruction and respiratory complications. RRP can also significantly affect quality of life for patients by affecting the voice box, limiting the ability to speak effectively. Surgery to remove papillomas is the standard of care for RRP; however, the papillomas often grow back. INOVIO’s market research to date with patients and healthcare professionals indicates that a reduction of even one surgery matters, because every surgery poses a significant risk of causing permanent damage to the vocal cords and comes with potential costs to the patient, including adverse impacts to both quality of life and finances. The most widely cited U.S. epidemiology data published in 1995 estimated that there were 14,000 active cases and about 1.8 per 100,000 new cases of RRP in adults each year.

About INO-3107
INO-3107 is an investigational DNA medicine designed to elicit an antigen-specific T cell response against both HPV-6 and HPV-11 proteins. These targeted T cells seek out and kill HPV-6 and HPV-11 infected cells, with the aim of potentially preventing or slowing the growth of new papillomas. In a Phase 1/2 trial of 32 participants (RRP-001), 72% of patients saw a 50-to-100% reduction in the number of surgeries after starting treatment with INO-3107 at the end of the first year. A retrospective study involving 28 of the original trial participants (RRP-002) showed this number increasing to 86% at the end of the second 12-month period with no additional dosing. Half of those patients required no surgeries at all. Patients in RRP-001 had a median of 4 surgeries (range: 2-8) in the year prior to dosing. At the outset of the trial (Day 0), patients had a clinically warranted procedure to have papillomas surgically removed, but any surgery performed after Day 0 was counted against the efficacy endpoint. Treatment with INO-3107 generated a strong immune response in the trial, inducing activated CD4 T cells and activated CD8 T cells with lytic potential. T cell responses were also observed at Week 52, indicating a persistent cellular memory response. INO-3107 was well tolerated, with trial participants experiencing mostly low-grade (Grade 1) treatment-emergent adverse effects such as injection site pain and fatigue. Like other DNA medicines, INO-3107 has shown the ability to generate antigen-specific T cells that is not affected by anti-vector immunity impacting immunogenicity, either before administration or after the first dose, unlike other T cell generating platforms such as viral vectors. This feature of DNA medicines is anticipated to allow INO-3107 to maintain T cell response and overall efficacy, which could make it an important therapeutic option for a majority of RRP patients.

The FDA has granted INO-3107 both Orphan Drug and Breakthrough Therapy designations and previously advised INOVIO that it could submit a BLA under the FDA’s accelerated approval program using data from INOVIO’s completed Phase 1/2 trial. The European Commission granted INO-3107 Orphan Drug designation. In addition, INOVIO has CE-marked its CELLECTRA delivery device in the EU, which allows INOVIO to commercialize the device in the EU and other geographies that recognize CE-marking. The United Kingdom awarded INO-3107 the Innovation Passport. This designation serves as the entry point to the Innovative Licensing and Access Pathway (ILAP), which aims to accelerate time to market and facilitate patient access to medicines.

(Press release, Inovio, NOV 3, 2025, View Source [SID1234659261])

On November 3, 2025 Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company developing next-generation therapeutics for difficult-to-treat cancers, reported a business update, and announced financial results for the quarter ended September 30, 2025.

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"In the dynamic landscape of emerging clinical-stage therapies for patients with recurrent and metastatic head and neck squamous cell carcinoma, a significant unmet medical need remains despite the potential improvements in treatment options," said Lara S. Sullivan, M.D., President, Chief Executive Officer and Chief Medical Officer of Pyxis Oncology. "We look forward to presenting our preliminary data from the ongoing clinical studies evaluating MICVO as a novel potential treatment option for recurrent and metastatic head and neck squamous cell carcinoma. We believe that the breadth of the MICVO clinical program, encompassing monotherapy and combination approaches, holds significant promise and this inflection point will further underscore our first-in-concept ADC’s potential to improve outcomes across multiple lines of therapy."

Pipeline & Corporate Updates
•
Pyxis Oncology expects to report preliminary data from the ongoing Phase 1 clinical studies of micvotabart pelidotin (MICVO) in patients with recurrent and metastatic head and neck squamous cell carcinoma (R/M HNSCC) in 4Q25.

o
Clinical update to focus on preliminary data from the Phase 1 monotherapy dose expansion study of MICVO for 2L/3L R/M HNSCC patients, including both the post platinum and anti-PD(L)-1 experienced arm and the post EGFRi and anti-PD(L)-1 experienced arm.
o
Additional preliminary clinical data from the Phase 1/2 combination dose escalation study of MICVO and KEYTRUDA (pembrolizumab) for 1L/2L+ R/M HNSCC patients will also be provided. The combination study is part of a Clinical Trial Collaboration Agreement with Merck (known as MSD outside of the US and Canada).
o
Pyxis Oncology expects to announce next steps in the clinical development plan for MICVO for R/M HNSCC along with the preliminary data update.

•
Pyxis Oncology presented new translational data in October 2025 in two posters at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025 and in six posters at the AACR (Free AACR Whitepaper)-NCI-EORTC International Conference, as well as three clinical trial in progress posters at ESMO (Free ESMO Whitepaper). The presentation posters at ESMO (Free ESMO Whitepaper) and AACR (Free AACR Whitepaper)-NCI-EORTC provided deeper insights into the pharmacodynamic responses of tumors to MICVO as well as MICVO’s unique mechanism of action and its potential to exert anti-tumor activity through three mechanisms: direct tumor cell killing, bystander killing and immunogenic cell death.
o
Translational findings highlighted MICVO’s effects on tumor microenvironment remodeling and immune activation, further reinforcing the potential benefit of MICVO as both a monotherapy and in combination with anti-PD1 therapy.
o
Observations included changes in circulating tumor DNA (ctDNA) tumor fraction (TF) to the vast majority of 37 clinical samples tested. Notably, reduction in ctDNA TF after treatment with MICVO, particularly in HNSCC and at the 5.4 mg/kg dose, support a positive molecular response to MICVO and strengthen rationale for continued development for this tumor type and dose in the monotherapy dose expansion study.
o
Additionally, features observed in nonclinical samples of the stromal architecture detected using AI-enabled hyper-resolution digital pathology may correlate with sensitivity to MICVO – a finding that may be unique compared to tumor cell surface targeting ADCs, due to MICVO’s targeting of a non-cellular structural component of the extracellular matrix.

Third Quarter 2025 Financial Results

•
As of September 30, 2025, Pyxis Oncology had cash and cash equivalents, including restricted cash, and short-term investments, of $77.7 million. The Company believes that its current cash, cash equivalents, and short-term investments will be sufficient to fund its operations into the second half of 2026.

•
Research and development expenses were $17.8 million for the quarter ended September 30, 2025, compared to $17.7 million for the quarter ended September 30, 2024. MICVO program-specific research and development costs increased by $2.0 million, primarily due to a $1.0 million increase in contract manufacturing costs and a $1.3 million increase in clinical trial related expenses related to monotherapy and combination therapy of MICVO. The increase in expenses was partially offset by a $1.8 million reduction in expenses related to PYX-106, as the clinical development of PYX-106 was paused in December 2024.

•
General and administrative expenses were $5.6 million for the quarter ended September 30, 2025, compared to $6.0 million for the quarter ended September 30, 2024. The decrease was primarily due to lower corporate insurance costs and a decrease in legal, professional and consulting fees.

•
Net loss was $22.0 million, or ($0.35) per common share, for the quarter ended September 30, 2025, compared to $21.2 million, or ($0.35) per common share, for the quarter ended September 30, 2024. Excluding non-cash stock-based compensation expense, the net loss for the quarter ended September 30, 2025 was $18.9 million, compared to a net loss of $18.2 million for the quarter ended September 30, 2024.

•
As of October 31, 2025, the outstanding number of shares of Common Stock of Pyxis Oncology was 62,264,215.

(Press release, Pyxis Oncology, NOV 3, 2025, View Source [SID1234659277])

On November 3, 2025 AAVivo, Inc., a pioneering biotechnology company developing novel, precision targeted biotherapeutics to enable in vivo generation of CAR-T cells, reported a presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2025, which is being held November 5-9, in National Harbor, MD.

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AAVivo will present a poster titled, "In Vivo Generation of CD19-Specific CAR-T Cells Using a Novel AAV Gene Therapy Platform to Treat B Cell Malignancies". The poster describes the Company’s lead candidate, AVO-100, a gene therapy that is designed using adeno-associated viruses (AAV) with capsids containing T cell-targeting (TCeT) moieties to produce CD19-specific CAR-T cells in patients. Preclinical data to date suggest that AVO-100 can be used to generate CD19-specific T cells from non-activated T cells in human PBMCs both in vitro and in vivo and the CAR-T cells can control the growth of Raji lymphoma in vitro and in NSG mice.

"We are pleased that a poster highlighting the potential of our iAAV platform to rapidly enable in vivo generation of CAR-T cells was accepted for presentation at SITC (Free SITC Whitepaper) 2025," said Haifeng Chen, Ph.D. Chief Technology Officer & Founder of AAVivo. "Having this research accepted for presentation at SITC (Free SITC Whitepaper), one of the preeminent oncology conferences, showcases the breadth of AAVivo’s patented technologies and the potential of AVO-100, our lead program targeting B-cell malignancies."

Details of the poster being presented at SITC (Free SITC Whitepaper) 2025 are as follows:

Abstract Number: 1001
Abstract Title: In Vivo Generation of CD19-Specific CAR-T Cells Using a Novel AAV Gene Therapy Platform to Treat B Cell Malignancies
Presenting Author: Haifeng Chen, Ph.D. Chief Technology Officer & Founder, AAVivo, Inc.
Session Date: Friday, Nov. 7

(Press release, AAVivo, NOV 3, 2025, View Source [SID1234659295])

On November 3, 2025 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported its financial results for the third quarter and nine months ended Sept. 30, 2025.

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"We delivered a strong third quarter, generating $83 million in revenue and 26,841 in total test report volume," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "These strong results are a testament to the workforce culture we have built at Castle and our unwavering commitment to improving patient care.

"Our momentum this quarter reflects the strength of our core dermatologic and gastrointestinal testing franchises, with DecisionDx-Melanoma and TissueCypher each surpassing 10,000 test reports for the first time in a single quarter, significant milestones that underscore the expanding adoption of our core tests. Based on our strong execution, we are raising our full-year 2025 total revenue guidance to $327-335 million from the previously provided range of $310-320 million.

"Additionally, with the launch of AdvanceAD-Tx, our new test designed to guide systemic treatment decision making in patients with moderate-to-severe atopic dermatitis, we are thrilled to provide an additional innovative, first-in-class, proprietary test addressing a significant unmet need in clinical dermatology."

Third Quarter Ended Sept. 30, 2025, Financial and Operational Highlights
•Revenues were $83.0 million, compared to $85.8 million in the third quarter of 2024. Affecting third quarter 2025 revenue was the Novitas local coverage determination (LCD), Genetic Testing in Oncology: Specific Tests, that included DecisionDx-SCC as noncovered, which became effective April 24, 2025, as well as the discontinuation of IDgenetix in May 2025.
•Delivered 26,841 total test reports in the third quarter of 2025, compared to 26,010 in the same period of 2024. Affecting third quarter 2025 test report volume was the Novitas LCD, Genetic Testing in Oncology: Specific Tests, that included DecisionDx-SCC as noncovered, which became effective April 24, 2025, as well as the discontinuation of IDgenetix in May 2025:
◦DecisionDx-Melanoma test reports delivered in the quarter were 10,459, compared to 9,367 in the third quarter of 2024.
◦TissueCypher Barrett’s Esophagus test reports delivered in the quarter were 10,609, compared to 6,073 in the third quarter of 2024.

◦DecisionDx-SCC test reports delivered in the quarter were 4,186, compared to 4,195 in the third quarter of 2024. Affecting third quarter test report volume was the Novitas LCD, Genetic Testing in Oncology: Specific Tests, that included DecisionDx-SCC as noncovered, which became effective April 24, 2025.
◦MyPath Melanoma test reports delivered in the quarter were 1,151, compared to 933 in the third quarter of 2024.
◦DecisionDx-UM test reports delivered in the quarter were 436, compared to 397 in the third quarter of 2024.
•Gross margin was 75%, and Adjusted Gross Margin was 77%, compared to 79% and 82%, respectively, for the same periods in 2024.
•Net cash provided by operations was $22.6 million, compared to $23.3 million for the same period in 2024.
•Net loss, which includes non-cash stock-based compensation expense of $12.1 million, was $0.5 million, compared to net income of $2.3 million for the same period in 2024.
•Net loss per share and Adjusted Net Loss per Share, Basic and Diluted, was $0.02, compared to net income per share and Adjusted Net Income per Share, Basic and Diluted, of $0.08, for the same period in 2024.
•Adjusted EBITDA was $9.2 million, compared to $21.6 million for the same period in 2024.

Nine Months Ended Sept. 30, 2025, Financial and Operational Highlights
•Revenues were $257.2 million, compared to $245.8 million during the same period in 2024. Affecting nine months ended September 30, 2025 revenue was the Novitas LCD, Genetic Testing in Oncology: Specific Tests, that included DecisionDx-SCC as noncovered, which became effective April 24, 2025, as well as the discontinuation of IDgenetix in May 2025.
•Delivered 77,817 total test reports in the nine months ended September 30, 2025, compared to 72,000 in the same period of 2024. Affecting nine months ended September 30, 2025 test report volume was the Novitas LCD, Genetic Testing in Oncology: Specific Tests, that included DecisionDx-SCC as noncovered, which became effective April 24, 2025, as well as the discontinuation of IDgenetix in May 2025:
◦DecisionDx-Melanoma test reports delivered in the nine months ended September 30, 2025, were 29,061, compared to 27,336 for the same period in 2024.
◦TissueCypher Barrett’s Esophagus test reports delivered in the nine months ended September 30, 2025, were 27,211, compared to 14,284 for the same period in 2024.
◦DecisionDx-SCC test reports delivered in the nine months ended September 30, 2025, were 13,323, compared to 12,049 for the same period in 2024. Affecting nine months ended September 30, 2025 test report volume was the Novitas LCD, Genetic Testing in Oncology: Specific Tests, that included DecisionDx-SCC as noncovered, which became effective April 24, 2025.
◦MyPath Melanoma test reports delivered in the nine months ended September 30, 2025, were 3,243, compared to 3,030 for the same period in 2024.
◦IDgenetix test reports delivered in the nine months ended September 30, 2025, were 3,605, compared to 14,026 for the same period in 2024. The Company discontinued its IDgenetix test offering effective May 2025.
◦DecisionDx-UM test reports delivered in the nine months ended September 30, 2025, were 1,374, compared to 1,275 for the same period in 2024.
•Gross margin for the nine months ended September 30, 2025, was 67%, and Adjusted Gross Margin was 80%, compared to 79% and 82%, respectively, for the same period in 2024.
•Net cash provided by operations was $37.4 million, compared to $40.5 million for the same period in 2024.
•Net loss, which includes non-cash stock-based compensation expense of $34.5 million, was $21.8 million, compared to net income of $8.7 million for the same period in 2024.
•Net loss per share, Basic and Diluted, was $0.76 and Adjusted Net Loss per Share, Basic and Diluted, was $0.06, compared to net income per share and Adjusted Net Income per Share, Basic and Diluted, of $0.31 and $0.30, respectively, for the same period in 2024.
•Adjusted EBITDA was $32.5 million, compared to $53.7 million for the same period in 2024.
Cash, Cash Equivalents and Marketable Investment Securities
As of Sept. 30, 2025, the Company’s cash, cash equivalents and marketable investment securities totaled $287.5 million.
2025 Outlook
Castle Biosciences is raising its guidance for anticipated total revenue in 2025. The Company now anticipates generating between $327-335 million in total revenue in 2025, compared to the previously provided guidance of between $310-320 million.
Third Quarter and Recent Accomplishments and Highlights

Dermatology- Skin Cancer
•DecisionDx-Melanoma: The Company presented new data demonstrating DecisionDx-Melanoma stratifies risk across histological subtypes at the 25th Annual Fall Clinical Dermatology Conference, which was held Oct. 23–26, 2025, in Las Vegas, Nevada. Specifically, cutaneous melanoma (CM) subtypes, such as superficial spreading and nodular melanoma, vary in how often they occur and in their outcomes. Even among patients with the same subtype, differences in tumor biology can lead to very different prognoses. In a real-world cohort of 13,560 patients with stage I–III CM from Castle’s ongoing collaboration with the National Cancer Institute’s Surveillance, Epidemiology and End Results (NCI’s SEER) Program Registries, DecisionDx-Melanoma stratified melanoma-specific survival (MSS) across different tumor subtypes. For example, five-year MSS in nodular melanoma was 98.5% for patients with Class 1A (lowest risk) test results versus 82.3% for patients with Class 2B (highest risk) test results; similar stratification was observed across superficial spreading, lentigo maligna and unspecified subtypes. These results suggest that DecisionDx-Melanoma provides clarity in overall risk beyond histology, supporting more informed treatment planning and potentially improved outcomes. See the Company’s news release from October 24, 2025, for more information.
•DecisionDx-SCC: Two new studies were published supporting the clinical utility of DecisionDx-SCC in patients with high-risk cutaneous squamous cell carcinoma (SCC). The first study represented a new validation milestone, establishing DecisionDx-SCC as a significant predictor of local recurrence (LR) in patients classified as high-risk by National Comprehensive Cancer Network (NCCN) guidelines, thereby adding a third utility to the test’s existing capabilities. The test has now been validated to predict individual risk of metastasis, benefit from adjuvant radiation therapy (ART) and risk of LR, providing comprehensive results to support tailored post-surgical management and treatment pathway recommendations for patients with SCC. The second publication shared results from a clinical impact study, affirming the impact of the test’s results in guiding these recommendations, specifically the use of ART and surveillance imaging, by providing actionable decision points based on individual patient risk. See the Company’s news release from August 25, 2025, for more information.
Gastroenterology
•The Company announced new data demonstrating the personalized risk stratification provided by its TissueCypher Barrett’s Esophagus (BE) test at the American Foregut Society’s (AFS) 2025 Annual Meeting. Specifically, this study evaluated TissueCypher’s ability to stratify risk in 85 patients diagnosed with non-dysplastic Barrett’s esophagus (NDBE) who received test results from four surgical practices. Patients with NDBE are generally considered to have the lowest risk of cancer progression, and current guidelines recommend surveillance every three to five years. However, while 85% of patients in the study received low-risk TissueCypher results, 15% were classified as intermediate- or high-risk by the TissueCypher test, indicating a significantly higher likelihood of progressing to high-grade dysplasia (HGD) or esophageal adenocarcinoma (EAC) than their pathology results suggested. Patients with intermediate-risk scores had a median five-year progression probability of 9%, and those with high-risk scores had a 16% probability. Both groups exceeded the 8.5% five-year risk of progression associated with expert-confirmed low-grade dysplasia (LGD) based on population estimates, which is the threshold at which guidelines recommend escalating to endoscopic eradication therapy (EET) or more frequent surveillance every six to twelve months. These findings show that TissueCypher can deliver clinically meaningful risk insights that can help physicians better tailor care for patients with BE. Notably, patients in the study with intermediate- and high-risk scores had similar or greater predicted progression risk than patients diagnosed with LGD, despite having a NDBE diagnosis. By identifying low-risk patients whose care can follow guideline-based surveillance intervals and intermediate- and high-risk patients who may benefit from earlier intervention, TissueCypher can potentially support more precise, risk-aligned management aimed at preventing disease progression. See the Company’s news release from September 9, 2025, for more information.

Dermatology- Atopic Dermatitis
•AdvanceAD-Tx: The Company announced the launch of AdvanceAD-Tx, a gene expression profile (GEP) test designed to guide systemic treatment decision making in patients ages 12 and older with moderate-to-severe atopic dermatitis (AD). This innovative 487-GEP test is designed to identify patients with a Janus kinase (JAK) inhibitor responder profile who are more likely to achieve an Eczema Area and Severity Index improvement of 90% (EASI-90), more quickly and with reduction of flares and itch by three months, when treated with a JAK inhibitor than those treated with a T helper type 2 (Th2)-targeted therapy. See the Company’s news release from November 3, 2025, for more information.
Corporate
•The Company announced that its founder, president and chief executive officer Derek Maetzold was named CEO of the Year by The CEO Magazine. The Executive of the Year Awards program recognizes senior executives driving measurable impact, innovation and inspiration. See the Company’s news release from October 1, 2025, for more information.
•The Company announced it was recognized as a Greater Pittsburgh Top Workplace by The Pittsburgh Post-Gazette. The designation is based exclusively on anonymous employee feedback gathered through a third-party survey. The confidential survey measures several aspects of workplace culture designed to be indicative of employee satisfaction and engagement, including feeling respected and supported, enabled to grow and empowered to execute. Castle was among just 89 companies honored with a Greater Pittsburgh Top Workplaces award in 2025. See the Company’s news release from September 23, 2025, for more information.
•The Company announced it was included in the inaugural 2025 America’s Greatest Companies list, published by Newsweek. The ranking honors 650 U.S. companies demonstrating strong performance across four key pillars: financial strength, workforce dedication, innovation, and commitment to environmental sustainability and corporate ethics. Evaluations were based on company reviews, filings with the U.S. Securities and Exchange Commission (SEC) and Patent and Trademark Office (USPTO), and third-party data sources to provide an objective measure of corporate performance. See the Company’s news release from September 17, 2025, for more information.

Conference Call and Webcast Details
Castle Biosciences will hold a conference call on Monday, November 3, 2025, at 4:30 p.m. Eastern time to discuss its third quarter 2025 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 November 24, 2025.
To access the live conference call via phone, please dial 833-470-1428 from the United States, or global dial-in numbers are available here: View Source, at least 10 minutes prior to the start of the call, using the conference ID 735311.
There will be a brief Question & Answer session following management commentary.

(Press release, Castle Biosciences, NOV 3, 2025, View Source [SID1234659246])