On November 7, 2024 Brenus Pharma reported the publication of a scientific article describing its new "off-the-shelf" cancer treatment in "Frontiers in Oncology" Section Cancer Immunity and Immunotherapy (Press release, Brenus Pharma, NOV 7, 2024, View Source [SID1234647988]).

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Brenus’ platform mimics patients’ relapsing conditions in lab, to educate the immune system against tumors evolution with the largest panel of multi-specific targets available. Its lead candidate is a proteomic-guided immunotherapy, designed to treat patients with advanced or metastatic CRC.

Results show that the murine surrogate treatment inhibits tumor growth and improves survival of treated mice bearing tumors. It has also shown efficacy in a PD1-resistant model, with an increased infiltration of CD8+T cells in cold tumors, associated with strong safety data.

Indeed, the treatment’s in vitro exposition to standards of care induces the expression of cancer-related proteins linked to therapeutic pressure, which were then safely rendered immunogenic by haptenation (in vitro chemical tagging). The final product thus obtained reinforces the recognition of tumor antigens by the immune system, allowing its activation against patient’s tumor cells after intradermal injection.

The findings, published in collaboration with renowned academic institutions and scientific partners, emphasize the potential of Brenus Pharma’s platform to overcome challenges faced in CRC, particularly in cases where standard immunotherapies like anti-PD1 have proven ineffective.

"These studies demonstrate that we can produce an immunotherapeutic approach inducing a safe anti-tumor response to target cancer cells in a proof-of-concept syngeneic mouse model. The technology has now been adapted with the human first candidate. This is providing solid foundations for the first-in-human study, moving us closer to offering therapeutic solutions for patients. We extend our gratitude to all co-authors for their invaluable contributions," said Dr. George Alzeeb, Innovation Manager at Brenus Pharma.

On November 7, 2024 Moderna, Inc. (NASDAQ:MRNA) reported financial results and provided business updates for the third quarter of 2024 (Press release, Moderna Therapeutics, NOV 7, 2024, View Source [SID1234649412]).

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"During the third quarter, we focused on execution with the launch of our updated COVID-19 and RSV vaccines in markets across the globe. I am pleased with the cost efficiency we achieved in the quarter, tracking ahead of where we planned to be at this time," said Stéphane Bancel, Chief Executive Officer of Moderna. "Looking into the fourth quarter and preparing for 2025, we remain focused on driving sales growth, delivering 10 product approvals over the next three years, and continuing to reduce our cost structure."

On November 7, 2024 Aulos Bioscience, an immuno-oncology company working to revolutionize cancer care through development of potentially best-in-class IL-2 therapeutics, reported positive results from its Phase 1/2 dose escalation and cohort expansion study of AU-007 (Press release, Aulos Bioscience, NOV 7, 2024, View Source [SID1234647921]). The data will be presented in a poster session at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 39th Annual Meeting in Houston, Texas.

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Preliminary Phase 2 data reveal that a combination of AU-007 and low-dose, subcutaneous aldesleukin is clinically active in melanoma, a finding consistent with Phase 1 data demonstrating clinical activity in a range of patients whose tumors had progressed through prior checkpoint inhibitors. Data from all 77 patients show durable reductions in immunosuppressive Treg cells – a result unprecedented in the IL-2 class – with a correlation between longer progression-free survival outcomes as Treg reduction deepens.

"We believe these data represent preliminary clinical proof of concept for our unique monoclonal antibody, AU-007, and we are confident in its emerging profile as a potential best-in-class therapeutic," said Aron Knickerbocker, Aulos Bioscience’s president and chief executive officer. "We look forward to presenting a fuller and more mature set of Phase 2 data for melanoma, renal cell carcinoma and non-small cell lung cancer in the first half of next year."

Key findings from preliminary results of the Phase 1/2 dose escalation and cohort expansion study of AU-007, with data available on 77 patients as of the data cutoff date of September 28, 2024, are as follows:

A tolerable and manageable safety profile was observed at all doses evaluated in Phase 1 dose escalation.

No dose-limiting toxicity occurred throughout Phase 1 dose escalation.
Most drug-related adverse events were Grade 1 or 2 except for:
Grade 3 anemia in one patient who entered the study with Grade 2 anemia, had rapid disease progression and received only two doses of the study drug.
Grade 4 cytokine release syndrome (CRS) in one patient that resolved with steroids, IV fluids and brief vascular pressor support, and did not require tocilizumab. This patient was noted retrospectively to have subclinical elevated IL-6 (5x upper limit of normal) serum levels, likely due to an active case of gout at baseline.
Transient Grade 3 elevated lipase in one patient that was not associated with clinical symptoms and resolved without intervention.
Transient (3-7 days) Grade 3 or 4 lymphopenias in six patients. The lymphopenias were not associated with adverse outcomes. Transient lymphopenia is a known effect of IL-2 treatment as lymphocytes traffic out of blood and into tissue.
Strong evidence of anti-tumor activity was observed in heavily pre-treated patients, particularly in melanoma.

Two patients with melanoma refractory to prior anti-CTLA-4 and anti-PD-1 therapy were treated with AU-007 every two weeks (Q2W) and one administration of low-dose, subcutaneous aldesleukin (recombinant human IL-2), and experienced deep and durable tumor shrinkages of 48% and 100% in target lesions.
One patient in dose escalation with acral melanoma that progressed rapidly on prior anti-PD-1 therapy received AU-007 Q2W and one loading dose of subcutaneous aldesleukin. This patient remained on AU-007 therapy for 11 months with disease control.
Anti-tumor activity was also observed in heavily pre-treated patients with renal cell carcinoma (RCC), bladder cancer, head and neck squamous cell carcinoma (HNSCC) and non-small cell lung cancer (NSCLC) whose tumors had progressed through checkpoint inhibitors.
AU-007 and low-dose, subcutaneous aldesleukin continues to demonstrate a unique pharmacodynamic (PD) profile in the IL-2 class.

A decrease in Tregs appears to be a critical determinant of observed efficacy, with greater median decreases observed in patients receiving one loading dose of low-dose, subcutaneous aldesleukin compared to low-dose, subcutaneous aldesleukin administered Q2W. Based on the Treg reduction levels and other PD findings, the company has made the decision to use the loading dose rather than the Q2W schedule of subcutaneous aldesleukin going forward.
Greater decreases in Tregs on treatment is associated with longer progression-free survival (PFS) across the Phase 1 and Phase 2 portions of the AU-007 trial. Patients with a Treg cell reduction greater than the median of 43% had longer PFS outcomes than those with a Treg cell reduction less than the median of 43%.
The Phase 2 expansion cohorts evaluating AU-007 and low-dose, subcutaneous aldesleukin continue to enroll patients, with a focus on melanoma and non-small cell lung cancer. An additional Phase 2 cohort will evaluate AU-007 and low-dose, subcutaneous aldesleukin combined with avelumab (checkpoint inhibitor; anti-PD-L1) in NSCLC. The company anticipates presenting updated clinical data in the first half of 2025.

The poster, "A phase 1/2 dose escalation and cohort expansion study of AU-007, a human monoclonal antibody (mAb) that binds to IL-2 and inhibits CD25 binding, plus low-dose aldesleukin in advanced solid tumors," (Abstract 685) is available to meeting registrants as an electronic poster on the SITC (Free SITC Whitepaper) 2024 virtual meeting platform. It will be presented in a poster session on Friday, November 8, 2024, 9:00 a.m.-7:00 p.m. CST in Exhibit Halls AB.

The poster presentation is also available on the Aulos Bioscience website in the Abstracts and Publications section.

To learn more about the AU-007 clinical trial program, please visit ClinicalTrials.gov (identifier: NCT05267626). For patients and providers in the U.S., please visit www.solidtumorstudy.com. For patients and health professionals in Australia, please visit www.solidtumourstudy.com.

About AU-007
AU-007 is a human IgG1 monoclonal antibody designed by leveraging artificial intelligence that is highly selective to the CD25-binding portion of IL-2. With a mechanism of action unlike any other IL-2 therapeutic in development, AU-007 redirects IL-2 to reinforce anti-tumor immune effects. This is achieved by preventing IL-2, either exogenous or secreted by effector T cells, from binding to trimeric receptors on regulatory T cells while still allowing IL-2 to bind and expand effector T cells and NK cells. This prevents the negative feedback loop caused by other IL-2-based treatments and biases the immune system toward activation over suppression. AU-007 also prevents IL-2 from binding to CD25-containing receptors on eosinophils, as well as vasculature and pulmonary endothelium, which may significantly reduce the vascular leak syndrome and pulmonary edema associated with high-dose IL-2 therapy.

On November 7, 2024 Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in genetic testing and precision medicine, reported financial results for its third quarter ended September 30, 2024 and updated its previously issued financial guidance on business performance for the full-year 2024 (Press release, Myriad Genetics, NOV 7, 2024, View Source [SID1234647938]).

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"During the third quarter of 2024, we grew revenue by 11%, compared to the third quarter of 2023, representing a fifth consecutive quarter of double-digit year-over-year revenue growth and have now delivered 13% revenue growth year-to-date as compared to the same nine-month period in 2023. This builds on the 11% revenue growth we reported for the full year 2023 and reflects the strength of our diversified product offerings, improved commercial execution, and the benefits of the enterprise-wide investments made over the last few years to improve customer service and ease of use," said Paul J. Diaz, President and CEO of Myriad Genetics. "We continue to focus on delivering profitable growth and free cash flow and are pleased with the significant progress we have made across the organization. These efforts, combined with prudent management of our cost structure, contributed to Myriad Genetics generating an improved net loss of $22.1 million and over $14 million in adjusted EBITDA in the third quarter. In October 2024, we hosted an investor event where we provided additional detail on our strategic initiatives, including enhancements to our existing products, and an update on our new product pipeline. These new products, once commercialized, have the potential to address a number of large market opportunities where we believe we will have highly differentiated proprietary solutions, providing us opportunities to accelerate growth going forward. These opportunities build on our mission and vision to reach more patients with life-changing precision medicine. Unfortunately, differentiated solutions often face obstacles to gain broad payor acceptance, as we recently experienced with UNH and its updated medical policy on multi-gene panel pharmacogenetic testing. We are disappointed UNH is restricting access to GeneSight, an important tool for healthcare providers, especially primary care providers, to help patients suffering from depression and anxiety to find the right medication treatment. We look forward to sharing additional clinical evidence for GeneSight with UNH and finding a positive resolution for patients."
Financial and Operational Highlights
•Test volumes of 376,000 in the third quarter of 2024 increased 6% year-over-year.
•The following table summarizes year-over-year testing volume changes in the company’s core product categories:

Three months ended September 30, Nine Months Ended September 30,
(in thousands)
2024 2023
% Change
2024 2023
% Change
Product volumes:
Hereditary cancer
74 71 5 % 219 207 5 %
Tumor profiling
13 13 — % 41 45 (9) %
Prenatal 162 156 3 % 506 469 8 %
Pharmacogenomics
127 116 10 % 380 343 11 %
Total 376 356 6 % 1,146 1,064 8 %

•The following table summarizes year-over-year revenue changes in the company’s core product categories:
Three months ended September 30, Nine Months Ended September 30,
(in millions)
2024 2023
% Change
2024 2023
% Change
Product revenues:
Hereditary cancer
$ 90.5 $ 86.5 5 % $ 270.1 $ 238.9 13 %
Tumor profiling
31.6 30.2 5 % 95.1 103.5 (8) %
Prenatal 43.5 39.5 10 % 132.2 111.3 19 %
Pharmacogenomics
47.7 35.7 34 % 129.6 102.9 26 %
Total $ 213.3 $ 191.9 11 % $ 627.0 $ 556.6 13 %

•Gross margin of 70.2% in the third quarter of 2024 increased 20 basis points year-over-year, reflecting operating leverage and improved average revenue per test. Adjusted gross margin in the third quarter of 2024 was 70.6%, an increase of 20 basis points year-over-year.
•Third quarter 2024 operating expenses were $169.8 million, decreasing 13% over the same period in the prior year due to significant legal costs incurred in the third quarter of 2023 that did not repeat in the third quarter of 2024. Operating expenses accounted for 80% of total revenue in the third quarter of 2024, down from 101% of total revenue in the third quarter of 2023. Adjusted operating expenses were $141.0 million, increasing 3% over the same period in the prior year and reflect ongoing investments in technology, research and development offset by cost management activities. Adjusted operating expenses accounted for 66% of total revenue in the third quarter of 2024, down from 72% of total revenue in the third quarter of 2023.
•Operating loss in the third quarter of 2024 was $20.0 million, improving $40.1 million year-over-year; adjusted operating income in the third quarter of 2024 was $9.5 million, improving $11.7 million year-over-year.

Business Performance and Highlights

Oncology
The Oncology business delivered revenue of $82.9 million in the third quarter of 2024.
•Third quarter 2024 hereditary cancer testing revenue in Oncology grew 11% year-over-year, reflecting both volume growth year-over-year and ongoing initiatives to improve average revenue per test.
•Third quarter 2024 tumor profiling revenue of $31.6 million grew 5% year-over-year, as contributions from Precise Tumor and Prolaris were partly offset by a challenged biopharma environment and the sale of the EndoPredict business on August 1, 2024.
•In October 2024, Myriad Genetics entered a collaboration with Flatiron Health, a leading health technology company, that allows physicians to order Myriad Genetics’ MyRisk Hereditary Cancer Test and view the results of the test directly in Flatiron’s cloud-based Electronic Medical Record (EMR) platform, OncoEMR.
•In October 2024, Myriad Genetics received a third patent relating to proprietary methods that generate ultra-sensitive detection of tumor-specific mutations in circulating tumor DNA (ctDNA), which is complementary to two patents granted earlier in the year for the company’s methods of preparing cell-free DNA. These patents support advancing commercialization of the company’s high sensitivity tumor informed molecular residual disease (MRD) assay.
•Myriad Genetics has established a number of additional research collaborations regarding the use of the company’s Precise MRD test for breast cancer patients, with leading cancer research institutions, including The University of Texas MD Anderson Cancer Center and the National Cancer Center Hospital East in Japan. Myriad Genetics has previously announced other MRD collaborations, including a metastatic breast cancer study with researchers at Memorial Sloan Kettering Cancer Center and a prospective pan-cancer study, including breast cancer, led by researchers at the National Cancer Center Hospital East in Japan.

Women’s Health
The Women’s Health business delivered revenue of $82.7 million in the third quarter of 2024.
•Prenatal testing revenue in the third quarter of 2024 grew 10% year-over-year, reflecting volume growth and ongoing initiatives to improve average revenue per test.
•Third quarter 2024 hereditary cancer testing revenue in Women’s Health declined 2% year-over-year with modest volume growth which was offset by the fact that a favorable change in estimate for average revenue per test in the third quarter of 2023 did not repeat in the third quarter of 2024. Year-to-date 2024 hereditary cancer testing revenue in Women’s Health grew 12% compared to the same nine-month period in 2023 as we believe more practitioners have seen the benefit of incorporating MyRisk with RiskScore as part of a comprehensive breast cancer risk assessment program.
•In October 2024, Myriad Genetics initiated a satellite media tour to coincide with new FDA guidelines to drive increased awareness and engagement around the connection between breast density and cancer risk. New FDA guidelines provide that mammography facilities are required to provide all patients receiving a mammogram with a breast density notification.
•In October 2024, Myriad Genetics established a strategic partnership with jscreen, a national organization providing access to genetic testing with a focus on high-risk populations. The partnership intends to reach hundreds of thousands of high-risk adults across the United States through targeted outreach and in-person genetic screenings.

Pharmacogenomics
In the pharmacogenomics business, GeneSight test revenue was $47.7 million in the third quarter of 2024.
•Third quarter 2024 GeneSight testing revenue grew 34% year-over-year, reflecting double-digit test volume growth year-over-year and ongoing initiatives to improve payor coverage and average revenue per test.
•Currently, biomarker legislation for state-regulated plans has passed in 15 states. In many of these states, commercial and managed Medicaid payers have modified their coverage policies to include GeneSight. Additionally, there are a number of states where legislation is in process. Myriad Genetics continues to see an increasing number of payors incorporating, or planning to incorporate, GeneSight into their coverage.
•During the third quarter of 2024, Myriad Genetics expanded payor coverage for several products, including GeneSight. Third quarter saw an additional 17 new contracts and expanded medical policies and coverage, enhancing access to our products, including GeneSight.

•On November 1, 2024, UNH updated its medical policy for pharmacogenetic testing to no longer provide coverage for certain multi-gene panel pharmacogenetic tests, including our GeneSight test, under its commercial and individual exchange benefit plans, effective January 1, 2025. After initial review of the updated policy, the company strongly disagrees with UNH’s decision and its rationale that there is insufficient evidence of efficacy to support coverage of GeneSight. Myriad Genetics is actively engaging with UnitedHealthcare to discuss additional evidence for Myriad Genetics’ proprietary and clinically differentiated mental health medication test, and is seeking to ensure that enrollees continue to have access to the test. We do not believe that the updated policy affects coverage of GeneSight by UNH under Medicare Advantage and managed Medicaid plans or coverage by other payors.

Cash Flow and Liquidity
For the third quarter of 2024, restricted and unrestricted cash increased by $8.6 million. As of the end of the third quarter of 2024, the company had cash and cash equivalents, excluding restricted cash, of $99.9 million and the ability to access an incremental $48.8 million of availability under its asset-based credit facility (the "ABL Facility"). The company had combined liquidity from its unrestricted cash and cash equivalents of $148.7 million.

Financial Guidance
Myriad Genetics does not provide forward-looking guidance on a GAAP basis for the measures on which it provides forward-looking non-GAAP guidance as the company is unable to provide a quantitative reconciliation of forward-looking non-GAAP measures to the most directly comparable forward-looking GAAP measure, without unreasonable effort, because of the inherent difficulty in accurately forecasting the occurrence and financial impact of the various adjusting items necessary for such reconciliations that have not yet occurred, are dependent on various factors, are out of the company’s control, or cannot be reasonably predicted. Such adjustments include, but are not limited to, real estate optimization and transformation initiatives, certain litigation charges and loss contingencies, costs related to acquisitions/divestitures and the related amortization, impairment and related charges, and other adjustments. For example, stock-based compensation may fluctuate based on the timing of employee stock transactions and unpredictable fluctuations in the company’s stock price. Any associated estimate of these items and its impact on GAAP performance could vary materially.

On November 7, 2024 XOMA Royalty Corporation (NASDAQ: XOMA), the biotech royalty aggregator, reported its third quarter 2024 financial results and highlighted recent activities (Press release, Xoma, NOV 7, 2024, View Source [SID1234647954]).

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"We continue to take a balanced approach to building a portfolio of sustainable cashflow streams by selectively acquiring royalty economics across the lifecycle of drug development," stated Owen Hughes, Chief Executive Officer of XOMA Royalty. "The September approval of MIPLYFFA, the first therapy approved for patients living with Niemann-Pick disease Type C, adds to our growing commercial royalty portfolio, while the recent transaction with Twist Bioscience further expands our early-stage portfolio, a key focus for us as we look to distribute risk across a diversified portfolio."

Key Third Quarter Events

Partner Event
Zevra Therapeutics The U.S. Food and Drug Administration (FDA) approved Zevra’s MIPLYFFA (arimoclomol) capsules as an orally delivered treatment for Niemann-Pick disease type C (NPC). MIPLYFFA is indicated for use in combination with miglustat for the treatment of neurological manifestations of NPC in adult and pediatric patients 2 years of age and older.
Rezolute
Announced the sunRIZE Phase 3 clinical trial investigating ersodetug (RZ358) in patients with congenital hyperinsulinism (CHI) will begin enrolling patients in the U.S. in early 20251.

Received FDA clearance to initiate Phase 3 registrational study for ersodetug for the treatment of hypoglycemia due to tumor hyperinsulinism2.

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Johnson & Johnson Presented neoadjuvant TAR-200 plus cetrelimab Phase 2 data in patients with muscle-invasive bladder cancer (MIBC) who are ineligible or refuse neoadjuvant platinum-based chemotherapy and are scheduled for radical cystectomy at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) 2024 Congress3.
Subsequent Events

Partner Event
Twist Bioscience XOMA Royalty completed a $15 million royalty monetization agreement with Twist, acquiring 50% of the future milestones and royalties and adding 60-plus partnered early-stage programs across 30 companies enabled by Twist Bioscience’s Biopharma Solutions business unit to the XOMA Royalty portfolio.
Johnson & Johnson Announced one of two Phase 3 clinical trials in difficult to treat muscle-invasive bladder cancer (MIBC) that included treatment with cetrelimab was being discontinued for not showing superiority to chemoradiation during a scheduled interim analysis4. Cetrelimab continues to be investigated in multiple other clinical trials.
Anticipated 2024 Events of Note

Partner Event
Takeda On December 12, 2024, Takeda will be hosting an R&D Day: Focus on Late-State Pipeline and Market Opportunity and has commented publicly mezagitamab will be discussed during this investor event.
Third Quarter 2024 Financial Results

XOMA Royalty recorded total income and revenues of $7.2 million for the third quarter of 2024, which included $6.5 million in estimated income associated with two commercial products in our portfolio. In the third quarter of 2023, XOMA Royalty reported total income and revenue of $0.8 million.

Research and development (R&D) expenses were $0.8 million in the third quarter of 2024, reflecting transitory clinical trial costs related to KIN-3248, an asset acquired in the Kinnate acquisition, which the Company currently is winding down. R&D expenses in the third quarter of 2023 were $25,000.

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General and administrative ("G&A") expenses were $8.0 million for the third quarter of 2024 compared with $6.4 million in the third quarter of 2023. The increase of $1.6 million was primarily comprised of $1.4 million in total costs incurred after our acquisition of Kinnate, which included $1.1 million in legal and consulting costs, $0.1 million in information technology costs, and $0.1 million in insurance costs. The remainder of the increased G&A expense reflects an increase of $0.2 million for salaries and related costs.

In the third quarter of 2024, as a result of communications with Agenus, XOMA Royalty evaluated the status of the partnered programs underlying the Agenus Royalty Purchase Agreement for potential impairment and recorded a one-time, non-cash impairment charge of $14.0 million and a reduction of royalty receivables of $14.0 million associated with Agenus.

In the third quarters of 2024 and 2023, G&A expenses included $2.6 million and $2.7 million, respectively, in non-cash stock-based compensation expenses.

Total interest expense in the third quarter of 2024 was $3.5 million, representing interest and costs related to the Blue Owl Loan established in December 2023.

The Company reported total other income, net, of $1.9 million in the third quarter of 2024, as compared to total other income, net, of $0.3 million in the corresponding period of 2023. The $1.6 million increase reflects a $1.3 million increase in investment income due to higher balances on our investments and the change in the market price for XOMA Royalty’s shares of Rezolute common stock.

Net loss for the third quarter of 2024 was $17.2 million, compared to a net loss of $5.5 million for the third quarter of 2023, primarily resulting from the $14.0 million non-cash impairment related to the Agenus Royalty Purchase Agreement.

On September 30, 2024, XOMA Royalty had cash and cash equivalents of $146.8 million (including $4.8 million in restricted cash). On December 31, 2023, XOMA Royalty had cash and cash equivalents of $159.6 million (including $6.3 million in restricted cash). During the third quarter of 2024, XOMA Royalty received $9.9 million in cash from royalty and commercial payments. Net cash used in operating activities during the quarter was $8.6 million. On October 15, 2024, the Company paid a total of $1.4 million in cash dividends on the 8.625% Series A Cumulative Perpetual Preferred Stock (Nasdaq: XOMAP) and the 8.375% Series B Cumulative Perpetual Preferred Stock (Nasdaq: XOMAO).