On August 4, 2025 BerGenBio ASA (the "Company") and Oncoinvent ASA ("Oncoinvent") reported regarding the contemplated combination of the Company, Oncoinvent and BerGenBio Norge AS though a statutory triangular merger (the "Merger") (Press release, BerGenBio, AUG 4, 2025, View Source;approval-of-the-merger-plan-and-the-fully-underwritten-rights-issue,c4214207 [SID1234654737]).

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An extraordinary general meeting of the Company was held on 12:00 hours (CEST) today by electronic means through Lumi AGM. All items on the agenda were resolved in accordance with the board of directors’ and the nomination committee’s proposals, including, but not limited to, approval of the merger plan dated 30 June 2025 (the "Merger Plan") and the fully underwritten rights issue in the Company to raise gross proceeds of NOK 130 million.

As announced by Oncoinvent today, the Merger Plan has been approved by the extraordinary general meeting of Oncoinvent. As a consequence, the decision to approve the Merger will now be filed with the Norwegian Register of Business Enterprises. Completion of the Merger remains subject to customary terms and conditions, as further described in the Merger Plan and the joint stock exchange announcement made on 30 June 2025.

The minutes from the extraordinary general meeting are attached hereto and will also be made available on the Company’s website www.bergenbio.no.

For further information regarding the Merger and the complete terms and conditions for the Merger, please see the Merger Plan with appendices available on www.bergenbio.no.

On August 4, 2025 Bristol Myers Squibb (NYSE: BMY) reported that the U.S. Food and Drug Administration (FDA) has accepted the supplemental biologics license application (sBLA) for Breyanzi (lisocabtagene maraleucel; liso-cel) as a potential treatment for adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least two prior lines of systemic therapy (Press release, Bristol-Myers Squibb, AUG 4, 2025, View Source;Food-and-Drug-Administration-FDA-in-Fifth-Cancer-Type-for-Relapsed-or-Refractory-Marginal-Zone-Lymphoma-MZL/default.aspx [SID1234654724]). The FDA has granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of December 5, 2025.

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"While initial therapy for MZL can be effective, multiple relapses over the course of several years are common, leaving patients in need of a new treatment option that can provide high, lasting response rates," said Rosanna Ricafort, vice president, Senior Global Program Lead for Hematology and Cell Therapy, Bristol Myers Squibb. "This FDA acceptance brings us one step closer to potentially standardizing CAR T cell therapy as a treatment option for MZL, while building on our commitment to bring this personalized therapy to as many eligible patients as possible."

The application is based on results from the primary analysis of the MZL cohort in TRANSCEND FL, an open-label, multicenter, Phase 2, single-arm study, which was shared in an oral presentation during the 2025 International Conference on Malignant Lymphoma (ICML) in June 2025.

The development progress of Breyanzi reflects BMS’ continued efforts to collaborate across the healthcare ecosystem, with the ultimate goal of reaching more patients and democratizing access to cell therapy. Recently, the FDA approved streamlined patient monitoring requirements and the removal of the REMS program for Breyanzi, easing known barriers to treatment and administration while maintaining patient safety.

About TRANSCEND FL
TRANSCEND FL (NCT04245839) is an open-label, global, multicenter, Phase 2, single-arm study to determine the efficacy and safety of Breyanzi in patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma, including follicular lymphoma and marginal zone lymphoma. The primary outcome measure is overall response rate. Secondary outcome measures include complete response rate, duration of response, and progression-free survival.

About MZL
Marginal zone lymphoma (MZL) is the third most common lymphoma, accounting for about 7% of all non-Hodgkin lymphoma cases. Most patients with MZL are at a median age of 67 years when they are diagnosed. MZL develops when white blood cells cluster together to form lumps in a person’s lymph nodes or organs. Initial therapy often leads to remission, but relapse is common, sometimes occurring several times over many years. A small portion of MZL cases transform into diffuse large-B-cell lymphoma, a more aggressive lymphoma.

About Breyanzi
Breyanzi is a CD19-directed CAR T cell therapy with a 4-1BB costimulatory domain, which enhances the expansion and persistence of the CAR T cells. Breyanzi is made from a patient’s own T cells, which are collected and genetically reengineered to become CAR T cells that are then delivered via infusion as a one-time treatment. The treatment process includes blood collection, CAR T-cell creation, potential bridging therapy, lymphodepletion, administration, and side-effect monitoring.

Breyanzi is approved in the U.S. for the treatment of relapsed or refractory large B-cell lymphoma (LBCL) after at least one prior line of therapy, has received accelerated approval for the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior lines of therapy and relapsed or refractory follicular lymphoma (FL) in the third-line plus setting, and is approved for the treatment of relapsed or refractory mantle cell lymphoma (MCL) in the third-line plus setting. Breyanzi is also approved in Japan, the European Union (EU), Switzerland, the United Kingdom, and Canada for the treatment of relapsed or refractory LBCL after at least one prior line of therapy; in Japan for the treatment of patients with relapsed or refractory high-risk FL after one prior line of systemic therapy, and in patients with relapsed or refractory FL after two or more lines of systemic therapy; and in the EU for the treatment of relapsed or refractory FL after two or more lines of systemic therapy.

Bristol Myers Squibb’s clinical development program for Breyanzi includes clinical studies in several types of lymphoma. For more information, visit clinicaltrials.gov.

Breyanzi U.S. FDA-Approved Indications

BREYANZI is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:

adult patients with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, who have:
refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or
refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age; or
relapsed or refractory disease after two or more lines of systemic therapy.
Limitations of Use: BREYANZI is not indicated for the treatment of patients with primary central nervous system lymphoma.

adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least 2 prior lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
adult patients with relapsed or refractory follicular lymphoma (FL) who have received 2 or more prior lines of systemic therapy. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least 2 prior lines of systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor.
Breyanzi U.S. Important Safety Information

WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, AND SECONDARY HEMATOLOGICAL MALIGNANCIES

Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving BREYANZI. Do not administer BREYANZI to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab with or without corticosteroids.
Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving BREYANZI, including concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with BREYANZI. Provide supportive care and/or corticosteroids as needed.
T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including BREYANZI.
Cytokine Release Syndrome

Cytokine release syndrome (CRS), including fatal or life-threatening reactions, occurred following treatment with BREYANZI. In clinical trials of BREYANZI, which enrolled a total of 702 patients with non-Hodgkin lymphoma (NHL), CRS occurred in 54% of patients, including ≥ Grade 3 CRS in 3.2% of patients. The median time to onset was 5 days (range: 1 to 63 days). CRS resolved in 98% of patients with a median duration of 5 days (range: 1 to 37 days). One patient had fatal CRS and 5 patients had ongoing CRS at the time of death. The most common manifestations of CRS (≥10%) were fever, hypotension, tachycardia, chills, hypoxia, and headache.

Serious events that may be associated with CRS include cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia), cardiac arrest, cardiac failure, diffuse alveolar damage, renal insufficiency, capillary leak syndrome, hypotension, hypoxia, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS).

Ensure that 2 doses of tocilizumab are available prior to infusion of BREYANZI.

Neurologic Toxicities

Neurologic toxicities that were fatal or life-threatening, including immune effector cell-associated neurotoxicity syndrome (ICANS), occurred following treatment with BREYANZI. Serious events including cerebral edema and seizures occurred with BREYANZI. Fatal and serious cases of leukoencephalopathy, some attributable to fludarabine, also occurred.

In clinical trials of BREYANZI, CAR T cell-associated neurologic toxicities occurred in 31% of patients, including ≥ Grade 3 cases in 10% of patients. The median time to onset of neurotoxicity was 8 days (range: 1 to 63 days). Neurologic toxicities resolved in 88% of patients with a median duration of 7 days (range: 1 to 119 days). Of patients developing neurotoxicity, 82% also developed CRS.

The most common neurologic toxicities (≥5%) included encephalopathy, tremor, aphasia, headache, dizziness, and delirium.

CRS and Neurologic Toxicities Monitoring

Monitor patients daily for at least 7 days following BREYANZI infusion for signs and symptoms of CRS and neurologic toxicities and assess for other causes of neurological symptoms. Continue to monitor patients for signs and symptoms of CRS and neurologic toxicities for at least 2 weeks after infusion and treat promptly. At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated. Manage neurologic toxicity with supportive care and/or corticosteroid as needed. Advise patients to avoid driving for at least 2 weeks following infusion. Counsel patients to seek immediate medical attention should signs or symptoms of CRS or neurologic toxicity occur at any time.

Hypersensitivity Reactions

Allergic reactions may occur with the infusion of BREYANZI. Serious hypersensitivity reactions, including anaphylaxis, may be due to dimethyl sulfoxide (DMSO).

Serious Infections

Severe infections, including life-threatening or fatal infections, have occurred in patients after BREYANZI infusion. In clinical trials of BREYANZI, infections of any grade occurred in 34% of patients, with Grade 3 or higher infections occurring in 12% of all patients. Grade 3 or higher infections with an unspecified pathogen occurred in 7%, bacterial infections in 3.7%, viral infections in 2%, and fungal infections in 0.7% of patients. One patient who received 4 prior lines of therapy developed a fatal case of John Cunningham (JC) virus progressive multifocal leukoencephalopathy 4 months after treatment with BREYANZI. One patient who received 3 prior lines of therapy developed a fatal case of cryptococcal meningoencephalitis 35 days after treatment with BREYANZI.

Febrile neutropenia developed after BREYANZI infusion in 8% of patients. Febrile neutropenia may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad- spectrum antibiotics, fluids, and other supportive care as medically indicated.

Monitor patients for signs and symptoms of infection before and after BREYANZI administration and treat appropriately. Administer prophylactic antimicrobials according to standard institutional guidelines. Avoid administration of BREYANZI in patients with clinically significant, active systemic infections.

Viral reactivation: Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells. In clinical trials of BREYANZI, 35 of 38 patients with a prior history of HBV were treated with concurrent antiviral suppressive therapy. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing. In patients with prior history of HBV, consider concurrent antiviral suppressive therapy to prevent HBV reactivation per standard guidelines. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing. In patients with prior history of HBV, consider concurrent antiviral suppressive therapy to prevent HBV reactivation per standard guidelines.

Prolonged Cytopenias

Patients may exhibit cytopenias not resolved for several weeks following lymphodepleting chemotherapy and BREYANZI infusion. In clinical trials of BREYANZI, Grade 3 or higher cytopenias persisted at Day 29 following BREYANZI infusion in 35% of patients, and included thrombocytopenia in 25%, neutropenia in 22%, and anemia in 6% of patients. Monitor complete blood counts prior to and after BREYANZI administration.

Hypogammaglobulinemia

B-cell aplasia and hypogammaglobulinemia can occur in patients receiving BREYANZI. In clinical trials of BREYANZI, hypogammaglobulinemia was reported as an adverse reaction in 10% of patients. Hypogammaglobulinemia, either as an adverse reaction or laboratory IgG level below 500 mg/dL after infusion, was reported in 30% of patients. Monitor immunoglobulin levels after treatment with BREYANZI and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement as clinically indicated.

Live vaccines: The safety of immunization with live viral vaccines during or following BREYANZI treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during BREYANZI treatment, and until immune recovery following treatment with BREYANZI.

Secondary Malignancies

Patients treated with BREYANZI may develop secondary malignancies. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including BREYANZI. Mature T cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusion, and may include fatal outcomes. Monitor lifelong for secondary malignancies. In the event that a secondary malignancy occurs, contact Bristol Myers Squibb at 1-888-805-4555 for reporting and to obtain instructions on collection of patient samples for testing.

Immune Effector Cell-Associated Hemophagocytic Lymphohistiocytosis-Like Syndrome (IEC-HS)

Immune Effector Cell-Associated Hemophagocytic Lymphohistiocytosis-Like Syndrome (IEC-HS), including fatal or life-threatening reactions, occurred following treatment with BREYANZI. Three of 89 (3%) safety evaluable patients with R/R CLL/SLL developed IEC-HS. Time to onset of IEC-HS ranged from 7 to 18 days. Two of the 3 patients developed IEC-HS in the setting of ongoing CRS and 1 in the setting of ongoing neurotoxicity. IEC-HS was fatal in 2 of 3 patients. One patient had fatal IEC-HS and one had ongoing IEC-HS at time of death. IEC-HS is a life-threatening condition with a high mortality rate if not recognized and treated early. Treatment of IEC-HS should be administered per current practice guidelines.

Adverse Reactions

The most common adverse reaction(s) (incidence ≥30%) in:

LBCL are fever, cytokine release syndrome, fatigue, musculoskeletal pain, and nausea. The most common Grade 3-4 laboratory abnormalities include lymphocyte count decrease, neutrophil count decrease, platelet count decrease, and hemoglobin decrease.
CLL/SLL are cytokine release syndrome, encephalopathy, fatigue, musculoskeletal pain, nausea, edema, and diarrhea. The most common Grade 3-4 laboratory abnormalities include neutrophil count decrease, white blood cell decrease, hemoglobin decrease, platelet count decrease, and lymphocyte count decrease.
FL is cytokine release syndrome. The most common Grade 3-4 laboratory abnormalities include lymphocyte count decrease, neutrophil count decrease, and white blood cell decrease.
MCL are cytokine release syndrome, fatigue, musculoskeletal pain, and encephalopathy. The most common Grade 3-4 laboratory abnormalities include neutrophil count decrease, white blood cell decrease, and platelet count decrease.
Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide.

On August 4, 2025 Anbogen Therapeutics reported that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for ABT-301, enabling the initiation of a Phase 1/2 clinical trial in combination with tislelizumab and bevacizumab for patients with metastatic colorectal cancer (mCRC) (Press release, Anbogen Therapeutics, AUG 4, 2025, View Source [SID1234654738]).

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This open-label, multi-center international study plans to enroll 66 patients with proficient mismatch repair (pMMR) or non-microsatellite instability-high (non-MSI-H) mCRC to evaluate the safety and preliminary efficacy of the triplet therapy. Enrollment is planned in Taiwan and Australia. Tislelizumab, a PD-1 monoclonal antibody, used in this trial is provided by BeOne Medicines (formerly known as BeiGene). Further details on this collaboration were disclosed by Anbogen in a press release dated September 27, 2024.

ABT-301 is an oral HDAC1/2/3 inhibitor. Preclinical studies have shown that it promotes CD8+ cytotoxic T cell infiltration and activity, enhances antigen presentation, and inhibits M-MDSCs cells, effectively modulating the tumor microenvironment and converting "cold tumors" into "hot tumors" to improve the efficacy of immune checkpoint inhibitors. ABT-301 also exhibits pro-apoptotic, anti-angiogenic, and tumor metabolic regulation effects. As a single-molecule, multi-modality anti-cancer agent, ABT-301 aims to enhance tumor treatment when combined with the two antibody drugs.

Notably, in a previous Phase 1 monotherapy clinical trial involving 23 participants, ABT-301 did not exhibit neutropenia or cardiac toxicity, which are commonly observed in other HDAC inhibitors—further supporting its suitability for use in combination immunotherapy.

Approximately 95% of mCRC patients are pMMR or non-MSI-H types—commonly referred to as "cold tumors"—which respond poorly to current immunotherapies. Only around 5% of patients with deficient mismatch repair (dMMR) or microsatellite instability-high (MSI-H) "hot tumors" typically benefit from immune checkpoint inhibitors. According to GlobalData, an estimated 370,000 new pMMR/non-MSI-H patients in second-line or later settings are diagnosed annually across the U.S., China, Japan, and the top five European markets (UK, France, Germany, Spain, and Italy), representing a potential market size of USD $9 billion.

Anbogen stated that the FDA’s IND approval marks a key milestone in the development of ABT-301, demonstrating the safety profile of the triplet therapy and advancing it into clinical stages. The company emphasized that the study targets the majority of patients (over 90%) with poor responses to immunotherapy, aiming to provide a novel treatment option and address this unmet clinical need.

Looking ahead, Anbogen will continue to advance the clinical development of ABT-301 while pursuing global licensing and strategic partnerships to accelerate commercialization and market entry. The company is also launching its Series B fundraising to attract strategic partners committed to advancing innovative cancer therapies and global expansion.

On August 4, 2025 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported its financial results for the second quarter and six months ended June 30, 2025 (Press release, Castle Biosciences, AUG 4, 2025, View Source [SID1234654725]).

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"Following a strong first quarter, our team closed out a very successful second quarter that we believe continued to reflect the clinical value our tests provide to clinicians and their patients," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "We saw very solid total year-over-year test volume growth in our core revenue drivers, with both DecisionDx-Melanoma and TissueCypher exceeding our volume expectations for the quarter, driving our top-line performance.

"In alignment with our capital allocation priorities and M&A strategy, we closed the Previse tuck-in acquisition and announced an exciting collaboration and license agreement with SciBase, both of which we believe will support our mid- to long-term value creation goals. At the same time, we remain deeply focused on execution across our current test portfolio, which we believe positions us well for continued near-term success. Our ability to invest in the future while advancing our core franchises reflects the strength of our growth initiatives and commitment to delivering sustainable value to our stakeholders."

Second Quarter Ended June 30, 2025, Financial and Operational Highlights
•Revenues were $86.2 million, compared to $87.0 million in the second quarter of 2024. Affecting second 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 discontinuation of IDgenetix in May 2025.
•Adjusted Revenues, which exclude the effects of revenue adjustments related to tests delivered in prior periods, were $86.2 million, compared to $86.6 million for the same period in 2024.
•Delivered 26,574 total test reports in the second quarter of 2025, an increase of 6% compared to 25,102 in the same period of 2024. Affecting second 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 discontinuation of IDgenetix in May 2025:
◦DecisionDx-Melanoma test reports delivered in the quarter were 9,981, compared to 9,585 in the second quarter of 2024.
◦TissueCypher Barrett’s Esophagus test reports delivered in the quarter were 9,170, compared to 4,782 in the second quarter of 2024.
◦DecisionDx-SCC test reports delivered in the quarter were 4,762, compared to 4,277 in the second quarter of 2024. Affecting second 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 1,166, compared to 1,099 in the second quarter of 2024.
◦IDgenetix test reports delivered in the quarter were 1,027, compared to 4,903 in the second quarter of 2024. The Company discontinued its IDgenetix test offering effective May 2025.
◦DecisionDx-UM test reports delivered in the quarter were 468, compared to 456 in the second quarter of 2024.
•Gross margin was 77%, and Adjusted Gross Margin was 80%, compared to 81% and 83%, respectively, for the same periods in 2024.
•Net cash provided by operations was $20.8 million, compared to net cash provided by operations of $24.0 million for the same period in 2024.
•Net income, which includes non-cash stock-based compensation expense of $11.2 million, was $4.5 million, compared to net income of $8.9 million for the same period in 2024.
•Net income per share and Adjusted Net Income per Share, Basic and Diluted, was $0.16 and $0.15, respectively, compared to $0.32 and $0.31, respectively, for the same period in 2024.
•Adjusted EBITDA was $10.4 million, compared to $21.5 million for the same period in 2024.

Six Months Ended June 30, 2025, Financial and Operational Highlights

•Revenues were $174.2 million, a 9% increase compared to $160.0 million during the same period in 2024. Affecting six months ended June 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 discontinuation of IDgenetix in May 2025.

•Adjusted Revenues, which exclude the effects of revenue adjustments related to tests delivered in prior periods, were $176.2 million, an 11% increase compared to $159.0 million for the same period in 2024.
•Delivered 50,976 total test reports in the six months ended June 30, 2025, an increase of 11% compared to 45,990 in the same period of 2024. Affecting six months ended June 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 discontinuation of IDgenetix in May 2025:
◦DecisionDx-Melanoma test reports delivered in the six months ended June 30, 2025, were 18,602, compared to 17,969 for the same period in 2024.
◦TissueCypher Barrett’s Esophagus test reports delivered in the six months ended June 30, 2025, were 16,602, compared to 8,211 for the same period in 2024.
◦DecisionDx-SCC test reports delivered in the six months ended June 30, 2025, were 9,137, compared to 7,854 for the same period in 2024. Affecting six months ended June 30, 2025 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 six months ended June 30, 2025, were 2,092, compared to 2,097 for the same period in 2024.
◦IDgenetix test reports delivered in the six months ended June 30, 2025, were 3,605, compared to 8,981 for the same period in 2024. The Company discontinued its IDgenetix test offering effective May 2025.
◦DecisionDx-UM test reports delivered in the six months ended June 30, 2025, were 938, compared to 878 for the same period in 2024.
•Gross margin for the six months ended June 30, 2025, was 63%, and Adjusted Gross Margin was 81%.
•Net cash provided by operations was $14.8 million, compared to $17.2 million net cash provided by operations for the same period in 2024.
•Net loss, which includes non-cash stock-based compensation expense of $22.4 million, was $21.3 million, compared to net income of $6.4 million for the same period in 2024.
•Net loss per share, Basic and Diluted, was $0.74 and Adjusted Net Loss per Share, Basic and Diluted, was $0.04, compared to Net income per share and Adjusted Net Income per Share, Basic and Diluted, of $0.23 and $0.22, respectively, for the same period in 2024.
•Adjusted EBITDA was $23.4 million, compared to $32.1 million for the same period in 2024.
Cash, Cash Equivalents and Marketable Investment Securities
As of June 30, 2025, the Company’s cash, cash equivalents and marketable investment securities totaled $275.9 million.
2025 Outlook
Castle Biosciences is raising its guidance for anticipated total revenue in 2025. The Company now anticipates generating between $310-320 million in total revenue in 2025, compared to the previously provided guidance of between $287-297 million.

Second Quarter and Recent Accomplishments and Highlights

Dermatology
•DecisionDx-Melanoma: DecisionDx-Melanoma test has been granted Breakthrough Device designation from the U.S. Food and Drug Administration (FDA). The FDA grants Breakthrough Device designation to select qualifying devices that may offer improved treatment or diagnosis of life-threatening or irreversibly debilitating diseases when compared to currently available alternatives. The Breakthrough Devices Program is intended to provide patients and healthcare providers with timely access to medical devices by speeding up development, assessment and review. See the Company’s news release from July 23, 2025, for more information.
•DecisionDx-Melanoma: Prior studies have shown that clinicians use DecisionDx-Melanoma to inform both avoiding sentinel lymph node biopsy procedures in low-risk patients and initiation of surveillance imaging and referrals to medical oncology in high-risk patients, which enables early detection of recurrences and initiation of therapy. Early detection has been shown to improve outcomes to a greater extent when therapy is initiated with smaller metastatic burden, which can improve net health outcomes. The Company presented novel research as part of Castle’s ongoing collaboration with the NCI’s SEER Program Registries at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The study presented an updated matching of patients who received DecisionDx-Melanoma as part of their clinical care to those who did not. In this large, real-world cohort of 13,560 patients with CM – the largest real-world study of gene expression profile testing to date – the DecisionDx-Melanoma was associated with a 32% reduction in mortality risk compared to untested patients, providing further evidence of the test’s association with improved patient survival. Additionally, test performance on independent risk stratification was re-confirmed. See the Company’s news release from May 29, 2025, for more information.
•DecisionDx-SCC: The Company submitted a DecisionDx-SCC reconsideration request for the Novitas LCD and received notification confirming acceptance of the reconsideration submission.
•DecisionDx-SCC: Two new studies were published in SKIN The Journal of Cutaneous Medicine supporting the clinical utility of DecisionDx-SCC in patients with high-risk cutaneous squamous cell carcinoma (SCC). The first study represents 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 study shares results from a clinician survey, 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.
Gastroenterology
•The Company closed its acquisition of Capsulomics, Inc., d/b/a Previse. This acquisition has the potential to increase Castle’s GI offerings. There is the potential to create a multiomics approach for improved patient care in Barrett’s esophagus, as well as a nonendoscopic sample collection device for pipeline opportunities to potentially expand screening and diagnostic support for patients with Barrett’s esophagus and other GI diseases. See the Company’s news release from May 5, 2025, for more information.
Uveal Melanoma
•The Company announced new data from the first independent validation of the recently published Collaborative Ocular Oncology Group Study No. 2 (COOG2.) by Harbour et al. The data, from a real-world cohort of 1,297 patients with uveal melanoma (UM), was presented at the Association for Research in Vision and Ophthalmology (ARVO) 2025 Annual Meeting in Salt Lake City. The findings provided further support for adding Preferentially Expressed Antigen in Melanoma (PRAME) gene expression information to the DecisionDx-UM test result to further refine metastatic risk prediction for patients with UM, which is a rare but aggressive eye cancer. See the Company’s news release from May 9, 2025, for more information.
Pipeline Initiatives
•The Company announced that it entered into a collaboration and license agreement with SciBase Holding AB ("SciBase") utilizing SciBase’s Electrical Impedance Spectroscopy technology, which includes both desktop and point-of-care instruments. The initial goal of the collaboration is to advance the development of a diagnostic test that predicts flares in patients diagnosed with atopic dermatitis (AD), a U.S., market with an estimated up to 24 million patients.1, 2 See the Company’s news release from June 16, 2025, for more information.
Corporate
•The Company announced that its founder, president and chief executive officer Derek Maetzold was awarded a distinguished Lifetime Achievement Award in the Management: Business Products Industries category in the 23rd Annual American Business Awards. The American Business Awards recognizes outstanding business performances in the United States, with more than 3,600 nominations from organizations of all sizes submitted this year for consideration in a wide range of categories. See the Company’s news release from June 4, 2025, for more information.
•The Company announced that it earned multiple awards through the 2025 Top Workplaces program: a third consecutive national Healthcare Industry Top Workplaces award, with Castle ranking third among other recognized companies in its size bracket; a fourth consecutive regional Arizona Top Workplaces award from AZ Central; and consecutive national Top Workplaces Culture Excellence awards for Innovation, Work-Life Flexibility, Compensation & Benefits, Leadership and Purpose & Values. Top Workplaces award designations are garnered solely through anonymous employee feedback gathered through a third-party survey administered by Energage. The confidential survey measures the workplace experience and various culture themes that are indicative of successful organizations. See the Company’s news release from July 17, 2025, for more information.
•The Company announced that Maetzold was also named a 2025 Most Admired CEO by the Houston Business Journal. This prestigious honor celebrates leaders who have demonstrated outstanding financial stewardship, fostered inclusive and thriving workplace cultures, and made meaningful contributions to the greater Houston community. See the Company’s news release from July 25, 2025, for more information.

Conference Call and Webcast Details
Castle Biosciences will hold a conference call on Monday, August 4, 2025, at 4:30 p.m. Eastern time to discuss its second 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 August 25, 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 638217.

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

On August 4, 2025 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that its global, multicenter, randomized Phase II registrational trial (COMPASSION-36/AK104-225) has been approved to initiate by both China’s National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA) (Press release, Akeso Biopharma, AUG 4, 2025, View Source [SID1234654739]). The trial will evaluate cadonilimab, Akeso’s first-in-class PD-1/CTLA-4 bispecific antibody, in combination with lenvatinib versus lenvatinib alone for the treatment of advanced hepatocellular carcinoma (HCC) in patients previously treated with atezolizumab (a PD-L1 inhibitor) and bevacizumab. Akeso is now moving forward with the initiation of the study.

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The COMPASSION-36/AK104-225 study is a key part of cadonilimab’s global development for hepatocellular carcinoma, continuing Akeso’s mission to advance cancer immunotherapy standards and to address the current limited survival benefits of single-target therapies. This international, multicenter Phase II trial is designed to tackle the common issue of limited treatment options following resistance to immune checkpoint inhibitors (IO) in cancer therapy.

Currently, immune checkpoint inhibitor (IO) combination therapies have become the standard first-line treatment for various advanced malignancies. However, for patients worldwide whose disease progresses after IO combination therapy, there is a lack of effective second-line treatment options. The very limited second-line treatment options for advanced malignancies drives the critical need to explore new therapeutic strategies. Cadonilimab-based combination therapies have shown substantial potential in overcoming IO resistance across multiple tumor types.

Hepatocellular carcinoma (HCC) is one of the most prevalent malignancies worldwide, with approximately 865,000 new cases of liver cancer reported globally in 2022. The combination of atezolizumab and bevacizumab (A+T regimen) is the standard first-line therapy for advanced HCC, as recommended by the NCCN guidelines. However, for patients whose disease progresses after first-line A+T treatment, there is currently no FDA-approved second-line therapy available in the U.S., and also no approved treatment options from the NMPA in China. This creates a significant unmet need in the clinical management of these patients.

Cadonilimab is the first bispecific antibody for cancer immunotherapy to be approved globally and also the first bispecific antibody to be approved in China. The potential of cadonilimab for the treatment of HCC has been validated in multiple studies：

At the 2023 European Society for Medical Oncology Asia Congress (ESMO Asia), a study was presented demonstrating that cadonilimab, combined with FOLFOX-HAIC as neoadjuvant therapy, achieved a 100% disease control rate (DCR) in patients with resectable multinodular HCC, with an acceptable safety profile.
Additionally, data presented at the 2023 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress revealed that the combination of cadonilimab and lenvatinib as first-line treatment for advanced HCC shows superior antitumor activity compared to currently approved therapies for advanced HCC.
Akeso’s exploration of combination therapies with cadonilimab in the treatment of HCC offers a broad and effective approach to disease management. These combinations address both early and advanced stages of HCC and provide promising therapeutic options for a wide range of patients:

In addition to the international multicenter Phase II registrational study COMPASSION-36, patient enrollment for the Phase III clinical trial of cadonilimab as adjuvant therapy for high-risk recurrence following curative surgery for HCC has been completed.
Furthermore, a Phase III registrational study of cadonilimab combined with lenvatinib and transarterial chemoembolization (TACE) for the treatment of intermediate to advanced unresectable HCC is currently ongoing.
Additionally, multiple Phase II studies investigating cadonilimab in combination with pulocimab (VEGFR-2), ivonescimab (PD-1/VEGF), and other therapies are currently underway for PD-1/L1 inhibitor-resistant non-small cell lung cancer (NSCLC), HCC, and other malignancies. These studies demonstrate cadonilimab’s potential in treating IO-resistant tumors.
Dr. Yu Xia, Founder, Chairwoman, President, and CEO of Akeso, remarked, "We are excited to initiate cadonilimab’s first international multicenter registrational trial, a pivotal step in addressing the global challenge of cancer immunotherapy resistance. This study represents a key milestone in Akeso’s global strategy to address the substantial clinical unmet needs in oncology. Akeso is advancing the clinical development of its innovative pipeline, including ivonescimab, cadonilimab, ligufalimab (CD47), and AK146D1 (Trop2/Nectin4 bispecific ADC) through both in-house initiatives and strategic global collaborations. Our goal is to provide accessible and impactful survival benefits to patients worldwide, and to position Akeso at the forefront of oncology innovation."