On March 18, 2024 OmniAb, Inc. (NASDAQ: OABI) reported financial results for the three and 12 months ended December 31, 2024, and provided operating and partner program updates (Press release, OmniAb, MAR 18, 2025, View Source [SID1234651234]).

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"2024 was a remarkable year featuring double-digit percentage growth in the number of both active partners and programs. Clinical-stage programs advanced well, and we launched new technologies and enhancements that strengthened our platform and expanded our reach," said Matt Foehr, Chief Executive Officer of OmniAb. "We exceeded our internal goals for key metrics and continued to build momentum while optimizing the scalability of our business. We believe our commitment to innovation is a significant competitive advantage and creates exciting opportunities for future growth. We remain steadfast in our strategic direction and are excited about the prospects that lie ahead."

Fourth Quarter 2024 Financial Results

Revenue for the fourth quarter of 2024 was $10.8 million, compared with $4.8 million for the same period in 2023, with the increase primarily due to higher license and milestone revenue partially offset by lower service and royalty revenue.

Research and development expense was $13.3 million for the fourth quarter of 2024, compared with $14.8 million for the same period in 2023, with the decrease primarily due to lower stock-based compensation expense and outside expenses associated with third-party services. General and administrative expense was $7.4 million for the fourth quarter of 2024, compared with $7.9 million for the same period in 2023, with the decrease primarily due to lower stock-based compensation expense and lower external marketing and legal expenses.

Net loss for the fourth quarter of 2024 was $13.1 million, or $0.12 per share, compared with a net loss of $14.1 million, or $0.14 per share, for the same period in 2023.

Full Year 2024 Financial Results

Revenue for 2024 was $26.4 million, compared with $34.2 million for 2023, with the decrease primarily due to the recognition of a $10.0 million TECVAYLI milestone in 2023. Royalty revenue decreased primarily due to lower net product sales by partners.

Research and development expense for 2024 was $55.1 million, compared with $56.5 million for 2023, with the decrease primarily due to lower personnel costs and external expenses. General and administrative expense for 2024 was $30.7 million, compared with $33.3 million for 2023, with the decrease primarily due to non-recurring consulting and other outside service expenses incurred in 2023 related to our spin-out as a public company and lower legal and stock-based compensation expense.

Net loss for 2024 was $62.0 million, or $0.61 per share, compared with a net loss of $50.6 million, or $0.51 per share, for 2023.

As of December 31, 2024, OmniAb had cash, cash equivalents and short-term investments of $59.4 million.

2025 Financial Guidance

OmniAb today introduced 2025 financial guidance. OmniAb expects 2025 revenue to be in the range of $20 million to $25 million and operating expense to be in the range of $90 million to $95 million. In addition, OmniAb expects 2025 cash use to be lower than its cash use in 2024. Cash use in 2024 was $38.9 million, excluding the 2024 ATM issuance. The 2025 full year effective tax rate is expected to be approximately 0%.

Fourth Quarter 2024 and Recent Business Highlights

As of December 31, 2024, OmniAb had 91 active partners and 363 active programs, including 32 OmniAb-derived programs in clinical development or being commercialized. The Company signed 10 new license agreements in 2024, including two in the fourth quarter with Incyte Corporation and Photinia Biosciences. In addition, five new OmniAb-derived antibodies entered the clinic in 2024.

In December 2024, OmniAb launched OmniHub , a unified interface designed to provide partners with secure access to datasets to visualize their discovery campaign data with a variety of custom tools. This bioinformatics portal is designed to enable scalable and secure data transfer, advanced visualization and computational tool access.

Fourth quarter 2024 and recent partner highlights include the following:

IMVT-1402

Immunovant announced that its lead asset, IMVT-1402, is rapidly progressing with six Investigational New Drug (IND) applications now cleared and pivotal Phase 2b studies in Graves’ disease (GD) and difficult-to-treat rheumatoid arthritis now enrolling.
Immunovant is on track to initiate potentially registrational programs for three additional indications for IMVT-1402 by March 31, 2025. In addition, Immunovant anticipates initiating clinical trials evaluating IMVT-1402 in a total of 10 indications by March 31, 2026.
Batoclimab

Immunovant reported that the top-line results of the batoclimab trial in myasthenia gravis and the initial results from period 1 of the batoclimab trial in chronic inflammatory demyelinating polyneuropathy are expected by March 31, 2025.
Immunovant also plans to announce additional data from the batoclimab proof-of-concept study in GD, including six-month, treatment-free remission data in the summer 2025.
Additionally, Immunovant reported that top-line results from the pivotal program of batoclimab for the treatment of thyroid eye disease (TED), also known as Graves’ ophthalmopathy, are expected in the second half of 2025.
HanAll Biopharma announced that batoclimab has received Orphan Drug Designation from Japan’s Ministry of Health, Labor, and Welfare for active TED.
Acasunlimab

Genmab announced that a Phase 3 trial with acasunlimab as a second-line therapy in non-small cell lung cancer (NSCLC) is now enrolling patients and that they expect to provide an additional Phase 2 data update in NSCLC in 2025.
Zimberelimab

Arcus Biosciences expects to present overall survival (OS) data from the Phase 2 EDGE-Gastric study, which is evaluating domvanalimab plus zimberelimab and chemotherapy in upper gastrointestinal adenocarcinomas, in the fall of 2025.
Arcus Biosciences also expects to initiate three new expansion cohorts within the Phase 1/1b ARC-20 study in the first quarter of 2025, including one cohort for casdatifan plus zimberelimab in all-comer first-line clear cell renal cell carcinoma.
Sugemalimab

CStone announced the publication of the Phase 3 GEMSTONE-303 study results for sugemalimab in patients with unresectable locally advanced or metastatic G/GEJ adenocarcinoma in theJournal of the American Medical Association. Results showed that in patients with PD-L1 combined positive score ≥5, sugemalimab significantly improved both OS and progression-free survival (PFS) compared with the control group. Median OS was 15.6 months versus 12.6 months, and median PFS was 7.6 months versus 6.1 months.
CStone announced that they have entered into a strategic partnership with Pharmalink Store for commercialization of sugemalimab in the Middle East, North Africa and South Africa. Additionally, CStone has partnered with SteinCares to market sugemalimab in Latin America.
Mipletamig

Aptevo Therapeutics announced that 100% of patients in Cohort 1 of the mipletamig RAINIER Phase 1b/2 dose-optimization trial for frontline acute myeloid leukemia achieved remission within 30 days of treatment. Trial enrollment is ongoing. Aptevo also anticipates providing multiple data readouts in 2025 and presenting results at the American Society of Hematology (ASH) (Free ASH Whitepaper) meeting in the fourth quarter of 2025.
RNDO-564

Rondo Therapeutics presented data from preclinical studies of RNDO-564, a novel CD28 x Nectin-4 costimulatory bispecific antibody for advanced bladder cancer, at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium. RNDO-564 demonstrated robust anti-tumor activityin vivoandin vitro, including in an antibody-drug-conjugate-resistant bladder cancer model. Based on promising preclinical findings, Rondo is advancing RNDO-564 through IND-enabling studies and expects to initiate a Phase 1/b trial in relapsed/refractory, locally advanced/metastatic bladder cancer by year-end 2025.
Conference Call and Webcast

OmniAb management will host a conference call with accompanying slides today beginning at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss this announcement and answer questions. To participate via telephone, please dial (800) 549-8228 using the conference ID 84579. Slides, as well as the live and replay webcast of the call, are available at View Source

On March 18, 2025 Enzo Biochem, Inc. (NYSE: ENZ) ("Enzo" or the "Company") reported financial results for the fiscal second quarter ended January 31, 2025, with sequential quarter improvement in revenue, gross margin and operating profit / loss (Press release, Enzo Biochem, MAR 18, 2025, View Source [SID1234651217]).

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Financial Highlights

● The Company’s second-quarter gross margin percentage of 52% increased sequentially from 37% during Q1 2025 and increased from 49% during the second quarter of the prior year. These improvements were driven by change in revenues, cost efficiency actions completed, and mix of products sold.

● The Enzo Life Sciences Products segment, which excludes discontinued operations and Corporate overhead, achieved a $0.5 million operating profit during Q2 FY25, a $2M sequential improvement compared to a $1.5 operating loss during Q1 FY25, and a $0.2 million improvement compared to the second quarter of the prior year. These improvements were driven by change in revenues, cost efficiency actions completed, and mix of products sold.

● The operating loss results for the first half of FY25 for the Company’s continuing operations improved by $2.4 million. Through cost containment, the company reduced cost of revenues by 14%. In addition, spend in SG&A and R&D decreased by 22% and 27%, respectively. Product launches continue, despite the reduction in R&D.

● The Company’s second-quarter revenue of $7.3 million increased sequentially by $1.1 million from $6.2 million. This is an improvement of 18%. Year-over-year quarterly period revenue declined by 14% primarily from the timing of large order fulfillment and the market slowdown in the US.

● Enzo ended the second quarter with aggregate cash and cash equivalents of $40.3 million. The Board of Directors and management continue to be focused on conserving cash.

● Product Life Cycle maintenance continues with an increasing number of SKU launches. Enzo increased product launches to bolster the base business within the first half of the fiscal year, doubling the count of new products compared to the prior full year.

Recent Events

● As previously disclosed, the Company and plaintiffs have reached a class-wide settlement agreement pertaining to the April 2023 cyber incident and filed an unopposed motion for preliminary approval with the Court. The Court granted the motion and set a final fairness hearing on June 10, 2025. The settlement value of $7.5 million had been accrued for in our prior year financial statements and an initial payment was made subsequent to January 31, 2025 in an amount of $0.8 million.

● We continue to explore all strategic alternatives to maximize value for the Company’s stockholders, including without limitation, improving the market position and profitability of our services in the marketplace, and enhancing our valuation. We may pursue our goals through organic growth and strategic initiatives. Additionally, we will continue to review information regarding potential acquisitions or joint ventures, and provide information to third parties regarding potential dispositions of assets or business lines, including a potential sale of the Company, from time to time.

● The Company submitted a plan on February 21, 2025 to cure the market capitalization, stockholder’s equity and average closing stock price deficiencies and to return to compliance with the NYSE’s continued listing standards. The plan considers all available alternatives to cure the deficiencies identified by the NYSE, which plan is being reviewed by the NYSE. The Common Stock continues to be listed and trade on the NYSE, subject to the Company’s ongoing compliance with the NYSE’s other continued listing standards and the acceptance by the NYSE of this plan.

On March 17, 2025 Taiho Pharmaceutical Co., Ltd. (hereinafter "Taiho Pharmaceutical") and Araris Biotech AG (hereinafter "Araris"), a Swiss biotechnology company developing next-generation antibody drug conjugates (ADCs), reported that they have entered into a definitive agreement pursuant to which Taiho Pharmaceutical will fully acquire Araris (hereinafter "the Acquisition") (Press release, Taiho, MAR 17, 2025, View Source [SID1234651188]). Following necessary procedures, the Acquisition is expected to be completed in first half of 2025. The Acquisition follows a research collaboration between Taiho Pharmaceutical and Araris signed in November 2023.

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Under the terms of the agreement, Taiho Pharmaceutical will pay USD 400 million at closing, with the potential for additional milestone payments of up to USD 740 million.

Araris is a spin-off company of the Paul-Scherrer-Institute in Switzerland and pioneering the development of best-in-class ADCs with superior design, high linker solubility and simple manufacturing that address the shortcomings of current generation ADCs. ADCs are designed to selectively deliver cytotoxic drugs (payloads) to cancer cells by attaching them to antibodies that bind specifically to cancer cells through linkers. Foundational to its approach is its novel, proprietary ADC linker platform AraLinQ. This platform has generated highly uniform, stable and potent ADC therapeutic candidates that have demonstrated a wider range of safety and increased antitumor effect compared to conventional ADCs in preclinical studies.i,ii Furthermore, Araris is advancing three products for the treatment of hematological and solid tumors developed using its unique AraLinQ technology, which are currently in the preclinical stage. These products are anticipated to enter into clinical trials between 2025 and 2026.

Taiho Pharmaceutical, in addition to antimetabolites, has established and created novel drugs through its proprietary small molecule drug discovery platform, Cysteinomix, enhancing cancer treatment and contributing to patient care. By acquiring Araris’ innovative ADC drug discovery technology platform along with Cysteinomix, Taiho Pharmaceutical will further expand its ongoing development portfolio in the field of oncology.

Masayuki Kobayashi, President and Representative Director of Taiho Pharmaceutical commented, "We are very pleased to have entered into this agreement with Araris. AraLinQTM is an innovative technology that enables next-generation ADC drug discovery. We are confident that the addition of Araris’ knowledge, experience and technology platform in ADC drug discovery, as well as its development pipeline, will lead to further expansion and strengthening of Taiho’s drug discovery capabilities and portfolio. Going forward, together with Araris, we will strive to develop innovative drugs that can contribute to patients globally."

Dragan Grabulovski, CEO and Co-founder of Araris commented, "Araris’ unique ADC technology represents a quantum leap for the ADC field, potentially offering precise payload delivery of multiple mechanisms of action simultaneously to the tumor, with less toxicity. We are proud to combine with Taiho, our partner since November 2023, whose significant cancer expertise will support us in turbo-charging the clinical development of our potent ADC candidates in hematological and solid tumors."

Dima Kuzmin, Managing Partner of 4BIO Capital and Chairman of Araris, added: "This acquisition validates Araris’ position as one of the most exciting ADC companies in the market. Having worked with Araris closely during its collaboration, Taiho knows the potential of Araris’ proprietary AraLinQ technology and is best placed to accelerate these transformative treatments to patients."

With the Acquisition, Araris will become a wholly owned subsidiary of Taiho Pharmaceutical and will continue its business, research and development activities at its current location in Zurich, Switzerland.

About AraLinQTM

AraLinQTM is Araris’ linker technology, which enables site-specific payload attachment to a privileged attachment site on a specific amino acid (Q295) within the antibody IgGFc framework. When a payload is attached to this site, the antibody still maintains nearly identical performance (e.g. pharmacokinetics and effector functions) to the unconjugated, original antibody. Furthermore, the linker-payload is connected to the antibody through a very strong peptide bond resulting in exceptional stability in the blood stream and therefore, avoidance of healthy tissue damage. However, once entering a cancer cell via antibody mediated internalization, the linker can be easily broken to release the payload and kill the cancer cell. All three of these properties are key factors to enable the most efficient payload delivery and maximum ADC efficacy.

AraLinQTM linkers are hydrophilic, rendering them soluble in water-based solutions like blood. Improved solubility leads to decreased clumping, allowing the ADC to properly bind to cancerous cells without the need to further edit the antibody/payload structures. In addition, this linker can have unique branching structures which makes it possible to create ADCs that carry multiple payloads of different types. AraLinQTM can also generate ADCs in one step using "off-the-shelf" antibodies that are native or engineered. The process is fast, cost-efficient and can be easily upscaled without the need for custom antibody synthesis.

Advisors

MTS Health Partners, L.P is serving as a financial advisor and Wilson Sonsini Goodrich & Rosati PC and Homburger AG is serving as the legal advisor for Taiho Pharmaceutical. Centerview Partners UK LLP is serving as financial advisor to Araris, and Cooley LLP and BGPartner Ltd are serving as legal advisors.

On March 17, 2025 XOMA Royalty Corporation (NASDAQ: XOMA), the biotech royalty aggregator, reported its fourth quarter and full year 2024 financial results and highlighted recent activities (Press release, Xoma, MAR 17, 2025, View Source [SID1234651191]).

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"Our balanced approach to building the scale of XOMA Royalty’s portfolio by selectively acquiring royalty economics across the lifecycle of drug development is beginning to bear fruit," stated Owen Hughes, Chief Executive Officer of XOMA Royalty. "Our growing commercial royalty portfolio of six assets is supported by VABYSMO (faricimab), OJEMDA, and MIPLYFFA, while our Phase 3 portfolio, which now totals 11 assets, promises several key readouts in 2025, including ersodetug from Rezolute, seralutinib from Gossamer Bio, and Ovaprene (non-hormonal vaginal ring) from Daré Biosciences. With over $100 million in cash on hand and a clear path to sustainable cashflow from royalties alone, we are well-positioned to further our goal of driving value for patients and shareholders alike."

Royalty and Milestone Acquisitions

Partner
Asset and Transaction Detail

Twist Bioscience XOMA Royalty completed a $15 million royalty monetization agreement with Twist, acquiring 50% of the future milestones and royalties in 60-plus partnered early-stage programs across 30 companies enabled by Twist Bioscience’s Biopharma Solutions business unit.
Daré Bioscience XOMA Royalty added economic interests to three best- or first-in-category assets to its portfolio for a $22 million upfront payment. XACIATO vaginal gel 2% is commercially available and marketed by Organon. Bayer holds the U.S. rights to commercialize Ovaprene, a hormone-free monthly intravaginal contraceptive, currently in Phase 3 clinical trials. XOMA Royalty also acquired a synthetic royalty in Sildenafil Cream, 3.6%, a Phase 3-ready asset for female sexual arousal disorder.

Talphera, Inc. XOMA Royalty acquired an economic interest in DSUVIA (sufentanil sublingual tablet) from Talphera, Inc., for $8 million. XOMA Royalty is entitled to royalties from DSUVIA sales. Alora Pharmaceuticals discontinued its DSUVIA commercial activities in November 2024. We remain eligible for payments from sales to the U.S. Department of Defense.
Company Acquisitions

Acquired Company
Rationale

Kinnate Biopharma Kinnate stockholders received $2.5879 per share in cash plus a Contingent Value Right (CVR) on April 3, 2024. The acquisition added approximately $7.8 million in cash and five assets to the XOMA Royalty portfolio.
Pulmokine Inc. XOMA Royalty secured a milestone and royalty interest in Gossamer Bio and Chiesi Farmaceutici’s seralutinib held by Pulmokine, a private company. Seralutinib is a Phase 3 asset being studied in pulmonary arterial hypertension (PAH), and Gossamer expects to initiate a registrational Phase 3 study in pulmonary hypertension associated with interstitial lung disease (PH-ILD) in 20251. Acquisition cost was $20 million upfront.
Product Approvals

Partner
Event

Day One Biopharmaceuticals The U.S. Food and Drug Administration (FDA) approved Day One’s OJEMDA (tovorafenib) for use in patients with pediatric low-grade glioma (pLGG). XOMA Royalty earned a $9.0 million milestone upon the approval and recorded $2.7 million in income resulting from OJEMDA sales in 2024. In addition, XOMA Royalty received an $8.1 million payment related to Day One’s sale of its priority review voucher.
Zevra Therapeutics The 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.

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Out-licensing Activities

Partner
Event

Alexion In December 2024, following its acquisition of Amolyt, Alexion (an AstraZeneca company) exercised Amolyt’s option to continue developing anti-PTH1R monoclonal antibodies that originated from XOMA’s discovery efforts as potential treatments for primary hyperparathyroidism and humoral hypercalcemia of malignancy. XOMA Royalty will be eligible to receive up to $10.5 million in milestone payments and royalties ranging from low single to low double-digits on net commercial sales. Upon Alexion’s exercise of the option, XOMA Royalty earned a $0.5 million payment.
Kinnate In early 2025, XOMA Royalty secured license agreements with several parties for the five unpartnered Kinnate assets. Per the terms of the acquisition, a portion of any upfront payments received by XOMA Royalty will be distributed to the Kinnate CVR holders.
Subsequent Events

Partner
Event

Rezolute
Received Breakthrough Therapy Designation from FDA for ersodetug (RZ358) for the treatment of hypoglycemia due to congenital hyperinsulinism (cHI)2.

Announced the independent Data Monitoring Committee reviewed the safety data from eight infants ages 3 months to 1 year enrolled in the open-label portion of the sunRIZE Phase 3 study of ersodetug for the treatment of hypoglycemia due to cHI. Their conclusion was the safety profile was such that infants may now be enrolled in the double-blind, placebo-controlled study3.

Castle Creek
XOMA Royalty added a royalty interest in D-Fi (FCX-007), a Phase 3 asset being developed by Castle Creek Biosciences, to the portfolio. D-Fi is being studied in dystrophic epidermolysis bullosa (DEB), a rare progressive and debilitating skin disorder. D-Fi has been granted Orphan Drug Designation for the treatment of DEB, as well as Rare Pediatric Disease, Fast Track, and Regenerative Medicine Advanced Therapy designations by the FDA.

XOMA Royalty contributed $5 million to Castle Creek Biosciences’ $75 million syndicated royalty financing transaction.

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Affitech Research AS XOMA Royalty paid $6 million in milestones to Affitech related to VABYSMO (faricimab-svoa) achieving specific sales thresholds. This was the final payment due to Affitech.
Anticipated 2025 Events of Note

Partner
Event

Rezolute
Completion of enrollment in sunRIZE Phase 3 clinical trial, which is investigating ersodetug in infants and children with cHI. Topline results are expected in the fourth quarter of 20252.

First patient dosed in Phase 3 registrational study for ersodetug for the treatment of hypoglycemia due to tumor hyperinsulinism4.

Gossamer / Chiesi
Presentation of topline results from the Phase 3 PROSERA study, a global registrational clinical trial in patients with WHO Function Class II and III pulmonary arterial hypertension (PAH).5

Initiation of a registrational Phase 3 study in pulmonary hypertension associated with interstitial lung disease (PH-ILD) in 2025.1

Takeda First patient dosed in Takeda’s Phase 3 clinical trial investigating mezagitamab as a treatment for adults with chronic primary immune thrombocytopenia (ITP).
Daré Bioscience Commencement of one of two registrational Phase 3 clinical trials investigating Sildenafil Cream, 3.6%, for the treatment of female sexual arousal disorder6.
Fourth Quarter and Full Year 2024 Financial Results

Tom Burns, Chief Financial Officer of XOMA Royalty, commented, "Based upon the anticipated incoming cash payments from royalties alone, we have line of sight on becoming cash flow positive on a consistent basis. The transient expenses associated with the Kinnate and Pulmokine acquisitions that impacted our 2024 financial results are coming to a close. We expect our R&D and G&A expenses to normalize in the second half of 2025."

Income and Revenue: XOMA Royalty recorded total income and revenues of $8.7 million and $28.5 million for the fourth quarter and full year of 2024, respectively. In 2023, XOMA Royalty recorded total income and revenues of $1.8 million and $4.8 million for the fourth quarter and full year, respectively. The increase for the full year of 2024 was primarily driven by an increase in our income from purchased receivables.

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Research and Development (R&D) Expenses: R&D expenses were $0.9 million and $2.9 million in the fourth quarter and full year of 2024, respectively. R&D expenses in the fourth quarter and full year of 2023 were $25,000 and $0.1 million, respectively. The increase of $2.8 million for the full year of 2024 is due to clinical trial costs related to KIN-3248 that were incurred subsequent to XOMA Royalty’s acquisition of Kinnate in April 2024. The Company currently is winding down this trial.

General and Administrative (G&A) Expenses: G&A expenses were $7.0 million and $34.5 million for the fourth quarter and full year of 2024, respectively, compared with $7.3 million in the fourth quarter and $25.6 million for the full year of 2023. The increase of $8.9 million for the full year of 2024 was primarily due to $7.4 million in costs associated with the acquisition of Kinnate, which primarily included $3.6 million in severance costs, $2.9 million in legal and consulting costs, $0.4 million in information technology costs, and $0.3 million in insurance costs. In addition, stock-based compensation expenses increased in 2024 by $1.2 million primarily due to the performance stock unit (PSU) grant awarded to Mr. Hughes in connection with his appointment as full-time CEO in January 2024.

In the fourth quarter and full year of 2024, G&A expenses included $2.2 million and $10.3 million, respectively, of non-cash stock-based compensation expenses. In the fourth quarter and full year of 2023, G&A expenses included $2.6 million and $9.1 million, respectively, of non-cash stock-based compensation expenses.

Credit Losses on Royalty and Commercial Payment Receivables (credit losses): In the fourth quarter of 2024, credit losses were $7.9 million related to the 2024 Talphera transaction. For the year ended December 31, 2024, credit losses totaled $30.9 million, consisting of $14.0 million related to the 2018 Agenus transaction, $9.0 million related to the 2019 Aronora transaction, and $7.9 million related to the Talphera transaction. For the year ended December 31, 2023, credit losses were $1.6 million related to the 2019 Bioasis transaction. There were no credit losses in the fourth quarter of 2023.

Interest Expense: Interest expense was $3.4 million and $13.8 million for the fourth quarter and full year of 2024, respectively. Interest expense in the fourth quarter and full year of 2023 was $0.6 million. Interest expense relates to the Blue Owl Loan established in December 2023.

Other Non-Comparable Transactions: Transactions for which there were no comparable period-over-period transactions include the following: In 2023, arbitration settlement costs of $4.1 million were paid in relation to a proceeding with one of XOMA Royalty’s licensees and a $14.2 million non-cash impairment charge was recorded in relation to the intangible ObsEva asset. In 2024, the Company recognized a gain on the acquisition of Kinnate of $19.3 million and an $8.1 million change in fair value of embedded derivative related to the Viracta transaction.

Other Income, net: The Company reported other income, net, of $1.0 million and $6.9 million for the fourth quarter and full year of 2024, as compared to $0.4 million and $1.6 million in the corresponding periods of 2023. The $5.3 million increase during the full year of 2024 was primarily driven by a $4.8 million increase in investment income due to higher balances on XOMA Royalty’s investments.

Net Loss: Net loss for the fourth quarter and full year ended December 31, 2024, was $4.0 million and $13.8 million, respectively, primarily resulting from the $30.9 million in non-cash credit losses on purchased receivables. Net loss for the fourth quarter and full year ended December 31, 2023, was $20.1 million and $40.8 million, respectively, which included $15.8 million in non-cash credit losses and impairment charges.

On December 31, 2024, XOMA Royalty had cash and cash equivalents of $106.4 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). In 2024, XOMA Royalty received $46.3 million in cash receipts including $20.0 million in royalties and commercial payments, $19.3 million in other receipts from purchased receivables, and $7.1 million from licensees. In addition, as of December 31, 2024, the Company netted approximately $7.8 million from its acquisition of Kinnate. In 2024, XOMA Royalty deployed $65 million to acquire new milestone and royalty assets and paid $5.5 million in dividends on the XOMA Royalty Perpetual Preferred stocks.

On March 17, 2025 Anocca AB, a leading T-cell immunotherapy company, reported the authorisation of its Clinical Trial Application (CTA) from the regulatory authorities in four European countries under the European Union’s (EU) harmonised framework, for VIDAR-1, with Germany acting as the reference state (Press release, Anocca, MAR 17, 2025, View Source [SID1234655345]). VIDAR-1 is a Phase I/II multi-product umbrella trial in patients with mutated KRAS-positive advanced pancreatic cancer. VIDAR-1 will test multiple products starting with the company’s lead product ANOC-001 that targets mutant KRAS G12V. ANOC-001 is a novel discovery from Anocca’s platform and will be manufactured in the company’s in-house cGMP facility.

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The CTA approval is the first regulatory authorisation in Europe to study a non-viral gene-edited TCR-T therapy in clinical practice, paving the way for the execution of Anocca’s scalable clinical product manufacturing strategy.

Phase I of the multi-centre trial will start in leading university hospitals in four northern European countries: Sweden, Denmark, Germany and The Netherlands. Anocca aims to initiate the study in Q2, 2025.

Reagan Jarvis, co-founder and Chief Executive Officer, commented, "This approval is a significant step in Anocca’s development as we transition to a clinical-stage company. Our highly skilled team is focused on discovering, optimising and manufacturing innovative next generation treatments that harness T-cell immunity and ANOC-001 represents the first of many products that will advance to the clinic in the coming years."

Zahid Bashir, Chief Medical Officer at Anocca, elaborated, "We are excited with the approval of VIDAR-1, as it represents a significant step towards addressing the unmet medical needs in patients with pancreatic cancer."

About the VIDAR-1 clinical programme

VIDAR-1 is designed as a multi-product umbrella trial targeting oncogenic driver mutations in KRAS within pancreatic ductal adenocarcinoma (PDAC). It will investigate up to 20 patients per product in a set of phase I/II studies. Phase I is planned for eight sites in four countries with additional countries and sites in phase II. The company plans to initiate first-in-human clinical studies in Q2, 2025. Patients will be eligible to enrol if they have an HLA, and KRAS mutation, matching an available product.

More information about the clinical trial can be found at the EU’s clinical trials website.

About KRAS and PDAC

Mutant KRAS is implicated in pancreatic, lung and colorectal cancers. G12V and G12D mutations in KRAS affect around 90% of pancreatic cancer patients. The five-year survival rate of patients with PDAC is less than 10% (1). Despite recent advances there are no definitive treatments for advanced patients at present (2).

References

1. Rawla et al (2019). Epidemiology of Pancreatic Cancer: Global Trends, Etiology and Risk Factors. World J Oncol. 10(1):10–27. doi: 10.14740/wjon1166

2. Hu & O’Reilly (2023). Therapeutic developments in pancreatic cancer. Nat Rev Gastroenterol Hepatol 21, 7–24. doi: 10.1038/s41575-023-00840-w