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Xencor Reports Fourth Quarter and Full Year 2024 Financial Results

On February 27, 2025 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies for the treatment of cancer and autoimmune diseases, reported financial results for the fourth quarter and full year ended December 31, 2024 and provided clinical updates and priorities for 2025 (Press release, Xencor, FEB 27, 2025, View Source [SID1234650719]).

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"In 2024, we began rebalancing our pipeline to focus on XmAb drug candidates that leverage our protein engineering strengths and reduce exposure to biological uncertainties—changes we believe increase our overall opportunities for clinical success. We are enthusiastic about ongoing advancement within our oncology portfolio of T-cell engager programs that are nearing important clinical inflection points. We have also introduced several candidates to be developed for patients with autoimmune disease, where there is a great need for new therapeutic agents beyond standard of care, and many of these programs will reach clinical milestones this year," said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor.

"In the first half of 2025, we look forward to presenting initial first-in-human healthy volunteer data for XmAb942, our potentially best-in-class, high potency, anti-TL1A antibody with extended half-life, which we are developing for people living with inflammatory bowel disease. In the second half of the year, we plan to present data from our Phase 1 dose-escalation study of XmAb819, our bispecific T-cell engager targeting ENPP3 in ccRCC at a major medical meeting."

Clinical Program Updates and 2025 Priorities

XmAb942 (Xtend anti-TL1A), a potential best-in-class, high-potency, extended half-life antibody in development for patients with inflammatory bowel disease. In the fourth quarter of 2024, Xencor initiated dosing of healthy volunteers in the first-in-human study of XmAb942. In the first half of 2025, Xencor will present initial data from the single-ascending dose portion of the study. In the second half of 2025, Xencor will present data from the multiple-ascending dose portion of the study and plans to initiate a Phase 2 study in participants with ulcerative colitis.

XmAb819 (ENPP3 x CD3), a first-in-class, tumor-targeted, T-cell engaging 2+1 bispecific antibody in development for patients with clear cell renal cell carcinoma (ccRCC). XmAb819 engages the immune system and activates T cells for highly potent and targeted lysis of tumor cells expressing ENPP3. Xencor is conducting a Phase 1 study to evaluate XmAb819 in patients with advanced ccRCC and plans to present initial data at a medical conference during the second half of 2025.

XmAb541 (CLDN6 x CD3), a first-in-class, tumor-targeted, T-cell engaging 2+1 bispecific antibody in development for patients with advanced solid tumors expressing CLDN6. Like XmAb819, XmAb541 engages the immune system and activates T cells for highly potent and targeted lysis of tumor cells expressing CLDN6. The 2+1 multivalent format enables greater selectivity for targeting the tumor-associated antigen CLDN6 over similar Claudin family members, and new preclinical data demonstrating this selectivity were presented in January 2025. A Phase 1 dose-escalation study to evaluate XmAb541 in patients with ovarian cancer and other CLDN6-expressing tumor types is ongoing, with characterization of target dose levels anticipated to begin during 2025.

XmAb808 (B7-H3 x CD28), a bispecific antibody to provide conditional co-stimulation of T cells when also bound to tumor cells. Dose escalation in an ongoing Phase 1 study combining XmAb808 with pembrolizumab resumed late in the fourth quarter of 2024, and enrollment in the final dose-escalation cohort is complete. To date a maximum tolerated dose has not been reached, and data from the study are expected to inform future development decisions for the program. Xencor does not plan to initiate expansion cohorts in combination with pembrolizumab. Potential combination with CD3 T-cell engaging bispecific antibodies is being evaluated.

Vudalimab (PD-1 x CTLA-4), a bispecific antibody that targets two immune checkpoint receptors for selective activation of T cells. In the fourth quarter of 2024, we completed enrollment in two studies of vudalimab in patients with metastatic castration-resistant prostate cancer (mCRPC) and in Part 1 of a study in patients with locally advanced or metastatic non-small cell lung cancer. Xencor has paused further development of vudalimab and has prioritized resources to advance other pipeline programs. Safety data from the three studies of vudalimab remain consistent with prior data disclosures.
Upcoming Clinical Study Initiation Plans

Plamotamab (CD20 x CD3), a clinical stage, B-cell depleting bispecific T-cell engager for development in rheumatoid arthritis (RA). Data demonstrating deep peripheral B-cell depletion observed in patients with lymphoma were presented at a medical meeting in December 2024. Xencor plans to evaluate plamotamab in RA, in which patients have progressed through prior standard-of-care treatment and initiate a Phase 1b/2a proof-of-concept study in the first half of 2025. The Phase 1b portion of the study will select a priming and step-up dose regimen based on the regimen established in oncology and will assess the initial safety, efficacy, and biomarkers of plamotamab in patients with RA. The selected dose regimen will then be evaluated in the randomized Phase 2a portion, with efficacy determined at week 12.

XmAb657 (CD19 x CD3), a potent, extended half-life B-cell depleting bispecific T-cell engager for development in autoimmune disease. Xencor plans to initiate a first-in-human study in the second half of 2025.

TL1A x IL23 Program: a bispecific antibody for dual targeting of important inflammatory pathways in autoimmune and inflammatory disease, while avoiding the complexities of dosing and formulary access for two separate TL1A and IL23 targeted drugs. Xencor anticipates selecting a lead candidate in 2025 and initiating first-in-human studies during 2026.
Recent Partnership Developments

Amgen: Xaluritamig is a STEAP1 x CD3 XmAb 2+1 bispecific T-cell engager that our partner Amgen is advancing for the treatment of patients with prostate cancer. In the fourth quarter of 2024, Amgen initiated a Phase 3 study of xaluritamig in patients with mCRPC who have previously been treated with taxane-based chemotherapy. We earned $30 million in milestone revenue, which we received in 2025. Multiple Phase 1 or Phase 1b studies evaluating xaluritamig as a monotherapy or in combination are enrolling patients with earlier prostate cancer.

Novartis: In the fourth quarter of 2024, Novartis initiated a Phase 2 study to evaluate an investigational antibody that incorporates an XmAb Fc domain, and Xencor earned $4 million in milestone revenue, which we received in 2025.
Financial Guidance: Based on current operating plans, Xencor expects to end 2025 with between $535 million and $585 million in cash, cash equivalents and marketable debt securities, and to have cash to fund research and development programs and operations into 2028.

Financial Results for the Fourth Quarter and Full Year Ended December 31, 2024

Cash, cash equivalents, and marketable debt securities totaled $706.7 million as of December 31, 2024 compared to $697.0 million as of December 31, 2023.

Total revenue for the fourth quarter ended December 31, 2024 was $52.8 million compared to $51.0 million for the same period in 2023. Revenue earned in the fourth quarter of 2024 was primarily the milestone revenue from Amgen and Novartis, as well as non-cash royalty revenue from Ultomiris and Monjuvi compared to the same period in 2023, which was primarily the research and milestone revenue from the two J&J collaboration agreements and non-cash royalty revenue from Ultomiris and Monjuvi. Revenue for the full year ended December 31, 2024 was $110.5 million compared to $174.6 million for the same period in 2023. Revenue in 2024 was primarily milestone revenue from Amgen and Novartis, licensing revenue, as well as non-cash royalty revenue from Ultomiris and Monjuvi compared to 2023, which was primarily milestone revenue from Alexion, Gilead, J&J, Omeros and Zenas and collaboration revenue from the second J&J collaboration.

Research and development (R&D) expenses for the fourth quarter ended December 31, 2024 were $51.1 million compared to $63.0 million for the same period in 2023. R&D expenses for the full year ended December 31, 2024 were $227.7 million compared to $253.6 million for the same period in 2023. Lower R&D expenses reflect decreased spending on the wind down costs of terminated programs, partially offset by increased spending on programs such as XmAb819, XmAb657 and XmAb942.

General and administrative (G&A) expenses for the fourth quarter ended December 31, 2024 were $14.9 million compared to $15.3 million for the same period in 2023. G&A expenses for the full year ended December 31, 2024 were $61.2 million compared to $53.4 million for the same period in 2023. Increased G&A spending reflects additional compensation costs on general and administrative staffing and spending on professional fees.

Other expense, net for the fourth quarter ended December 31, 2024 was $31.4 million compared to other income, net of $14.7 million for the same period in 2023. Other expense, net for the full year ended December 31, 2024 was $56.5 million compared to other income, net of $12.7 million in the same period in 2023.

Net loss attributable to Xencor for the fourth quarter ended December 31, 2024 was $45.6 million or $(0.62) on a fully diluted per share basis compared to net loss of $26.1 million or $(0.43) on a fully diluted per share basis, for the same period in 2023. For the full year ended December 31, 2024 net loss attributable to Xencor was $232.6 million or $(3.58) on a fully diluted per share basis compared to net loss of $133.1 million or $(2.20) on a fully diluted per share basis, for the same period in 2023.

Upcoming Investor Conferences

Company management will participate at multiple upcoming investor conferences:

TD Cowen 45th Annual Health Care Conference
Date: Tuesday, March 4, 2025
Presentation Time: 11:10 a.m. ET / 8:10 a.m. PT

Leerink Partners Global Healthcare Conference
Date: Tuesday, March 11, 2025
Presentation Time: 2:20 p.m. ET / 11:20 a.m. PT
Live webcasts of the presentations will be available under "Events & Presentations" in the Investors section of the Company’s website located at www.xencor.com. Replays of the events will be available on the Xencor website for at least 30 days following the presentations.

Supernus to Participate in the TD Cowen 45th Annual Health Care Conference

On February 27, 2025 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported that Jack A. Khattar, President and CEO of Supernus Pharmaceuticals, will participate in a fireside chat at the TD Cowen 45th Annual Health Care Conference on Monday, March 3, 2025, at 11:10 a.m. ET in Boston, Mass (Press release, Supernus, FEB 27, 2025, View Source [SID1234650718]).

Investors interested in arranging a meeting with company management during the conference should contact the TD Cowen conference coordinator. A live audio webcast of the presentation can be accessed here or by visiting Events & Presentations in the Investor Relations section on the Company’s website at www.supernus.com. An archived replay of the webcast will be available for 60 days on the Company’s website following the conference.

Puma Biotechnology Reports Fourth Quarter and Full Year 2024 Financial Results

On February 27, 2025 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported financial results for the fourth quarter and year ended December 31, 2024 (Press release, Puma Biotechnology, FEB 27, 2025, View Source [SID1234650717]). Unless otherwise stated, all comparisons are for the fourth quarter and full year 2024 compared to the fourth quarter and full year 2023.

Product revenue, net consists entirely of revenue from sales of NERLYNX, Puma’s first commercial product. Product revenue, net for the fourth quarter of 2024 was $54.4 million, compared to $53.2 million in the fourth quarter of 2023. Product revenue, net for the full year 2024 was $195.2 million, compared to $203.1 million in 2023.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported net income of $19.3 million, or $0.39 per basic and diluted share, for the fourth quarter of 2024, compared to net income of $12.3 million, or $0.26 per basic and diluted share, for the fourth quarter of 2023. Net income for full year 2024 was $30.3 million, or $0.62 per basic and diluted share, compared to net income of $21.6 million, or $0.46 per basic share and $0.45 per diluted share, for full year 2023.

The fourth quarter 2024 net income of $19.3 million, or $0.39 per basic and diluted share includes a partial release of our valuation allowance that favorably impacted net income by $7.1 million and favorably impacted earnings per share by $0.15 per basic and diluted share. This compares to net income in the third quarter 2024 of $20.3 million, or $0.41 per basic and diluted share.

Non-GAAP adjusted net income was $21.1 million, or $0.43 per basic and diluted share, for the fourth quarter of 2024, compared to non-GAAP adjusted net income of $14.8 million, or $0.31 per basic and diluted share, for the fourth quarter of 2023. Non-GAAP adjusted net income for full year 2024 was $38.5 million, or $0.79 per basic and $0.78 per diluted share, compared to non-GAAP adjusted net income of $31.8 million, or $0.68 per basic share and $0.67 per diluted share, for full year 2023. Non-GAAP adjusted net income excludes stock-based compensation expense. For a reconciliation of GAAP net income to non-GAAP adjusted net income and GAAP net income per share to non-GAAP adjusted net income per share, please see the financial tables at the end of this news release.

Net cash provided by operating activities for the fourth quarter of 2024 was $15.6 million, compared to net cash provided by operating activities of $10.5 million for the fourth quarter of 2023. Net cash provided by operating activities for full year 2024 was $38.9 million, compared to net cash provided by operating activities of $27.0 million for full year 2023. At December 31, 2024, Puma had cash, cash equivalents, and marketable securities of approximately $101 million, compared to cash, cash equivalents, and marketable securities of $96 million at December 31, 2023.

"We are very pleased with our financial results for the fourth quarter of 2024, as well as for the full year 2024, and we are very pleased to be able to report positive net income for the third consecutive year, reflecting our strong execution and disciplined financial management," said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. "This execution was driven by both our continued commercial performance in the United States and abroad, as well as effective implementation of our planned initiatives to raise patient awareness and expand access channels. In addition, we are pleased to be able to initiate the ALI-1201/ALISCA-Breast1 Phase II trial of alisertib in combination with endocrine treatment in patients with chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer in November, which is a significant step in our clinical development plan for alisertib."

Mr. Auerbach added, "We anticipate the following key milestones over the next 12 months: (i) presentation of interim data from the Phase I trial of neratinib given in combination with trastuzumab deruxtecan in solid tumors with HER2 alterations (H1 2025); (ii) presentation of interim data from ALISCA-Breast1, a Phase II trial of alisertib in combination with endocrine treatment in patients with chemotherapy-naïve HER2-negative, hormone receptor-positive metastatic breast cancer (2025); and (iii) presentation of additional interim data from the ALI-4201/ALISCA-Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer (2025).

Revenue

Total revenue consists of product revenue, net from sales of NERLYNX, license revenue and royalty revenue. For the fourth quarter of 2024, total revenue was $59.1 million, of which $54.4 million was product revenue, net and $4.7 million was royalty revenue. This compares to total revenue of $72.2 million for the fourth quarter of 2023, of which $53.2 million was product revenue, net and $19.0 million was royalty revenue. For the year ended December 31, 2024, total revenue was $230.5 million, of which $195.2 million was product revenue, net and $35.3 million was royalty revenue. This compares to total revenue in 2023 of $235.6 million, of which $203.1 million was product revenue, net and $32.5 million was royalty revenue. Puma reported no license revenue for the years ended December 31, 2024 and 2023.

Operating Costs and Expenses

Total operating costs and expenses were $45.7 million for the fourth quarter of 2024, compared to $57.4 million for the fourth quarter of 2023. Total operating costs and expenses were $199.5 million for full year 2024, compared to $203.0 million for full year 2023.

Cost of Sales

Cost of sales was $13.9 million for the fourth quarter of 2024, compared to $24.3 million for the fourth quarter of 2023. Cost of sales was $64.4 million for full year 2024, compared to cost of sales of $62.7 million for full year 2023. The $1.7 million increase in full year 2024 was primarily due to the increase of product unit sales to our sub-licensees and the related cost of sales (primarily sales in China), partially offset by lower domestic sales.

Selling, General and Administrative Expenses

Selling, general and administrative (SG&A) expenses were $16.6 million for the fourth quarter of 2024, compared to $20.2 million for the fourth quarter of 2023. SG&A expenses for full year 2024 were $80.2 million, compared to $89.9 million for full year 2023. The $9.7 million decrease in SG&A expenses for full year 2024 compared to 2023 resulted primarily from a decrease in professional fees and expenses of approximately $4.1 million, primarily due to a decrease in consultant and contractor expenses (primarily marketing related) of approximately $2.7 million, a decrease in legal fees of approximately $1.0 million, and a decrease in insurance and other expense of approximately $0.4 million; a decrease in payroll and related costs of approximately $1.9 million, primarily due to lower headcount, partially offset by annual salary increases; a decrease in provision for credit loss (recovery) of approximately $1.4 million, due to an overdue receivable as of December 31, 2023 that was collected in 2024; a decrease in stock-based compensation expense of approximately $1.3 million, primarily due to lower fair value on equity grants as a result of a lower market price for our common stock; and a decrease in loss on impairment of asset expense of $0.6 million in connection with our decision to sublease a portion of our leased office space in 2023, which was recorded as an operating asset in accordance with ASC 842.

Research and Development Expenses

Research and development (R&D) expenses were $15.2 million for the fourth quarter of 2024, compared to $12.9 million for the fourth quarter of 2023. R&D expenses for full year 2024 were $54.9 million, compared to $50.4 million for full year 2023. The $4.5 million increase in R&D expenses during full year 2024 compared to full year 2023 resulted from an increase in clinical trial expense of approximately $3.5 million, primarily due to the procurement of our alisertib drug product, as well as increased alisertib study activity, partially offset by the achievement of fewer clinical milestones; an increase in internal R&D of approximately $1.5 million, primarily due to higher compensation related to achieving company goals and one-time payroll and severance-related expenses; partially offset by a decrease in stock-based compensation of approximately $0.7 million, primarily due to lower fair value on equity grants as a result of a lower market price for our common stock.

Total Other Income (Expenses)

Total other expenses were $1.1 million for the fourth quarter of 2024, compared to total other expenses of $2.0 million for the fourth quarter of 2023. Total other expenses were $6.9 million for full year 2024, compared to $9.9 million for full year 2023. The $3.0 million decrease in other expenses in full year 2024 resulted primarily from a $2.1 million increase in interest income, which reflected higher balances in cash equivalents and marketable securities, and a $0.9 million decrease in interest expense, which was due to the pay down of debt in 2024, as well as ending imputed interest on $8.0 million related to the final installment payment of the Eshelman litigation settlement paid in October 2024.

Deferred Income Tax Benefit

In the fourth quarter of 2024, Puma released a portion of its valuation allowance resulting in a non-cash, deferred tax income benefit of $7.1 million. The valuation allowance was established to offset Puma’s deferred tax assets, which are primarily related to its historical losses. This significantly increased Puma’s net income for the fourth quarter and full year 2024.

First Quarter 2025 and Full Year 2025 Financial Outlook

First Quarter 2025

Full Year 2025

Net Product Revenue

$41–$43 million

$192–$198 million

Royalty Revenue

$1.5–$2.5 million

$20–$24 million

License Revenue

$0 million

Net Income/(Loss)*

$(2)–$0 million

$23–$28 million

Gross to Net Adjustment

22.5%–23.5%

20.5%–21.5%

*There are no tax valuation allowance adjustments included in the outlook above.

Conference Call

Puma Biotechnology will host a conference call to report its fourth quarter and full year 2024 financial results and provide an update on Puma’s business and outlook at 1:30 p.m. PT/4:30 p.m. ET on Thursday, February 27, 2025. The call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (international). Please dial in at least 10 minutes in advance and inform the operator that you would like to join the "Puma Biotechnology Conference Call." A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at View Source A replay of the call will be available approximately one hour after completion of the call and will be archived on Puma’s website for 90 days.

Personalis Reports Fourth Quarter and Full Year 2024 Financial Results

On February 27, 2025 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported financial results for the fourth quarter and full year ended December 31, 2024, and provided recent business highlights (Press release, Personalis, FEB 27, 2025, View Source [SID1234650716]).

Recent Business Highlights

•
Delivered 1,441 total molecular tests in the fourth quarter of 2024, an increase of 52% compared with 945 tests delivered in the third quarter of 2024; delivered 3,285 total molecular tests for the full year of 2024 compared with 177 in 2023

•
Submitted for Medicare coverage in early-stage breast cancer

•
Collaborators have submitted manuscripts for publication in peer-reviewed journals for all three Personalis focus indications in breast and lung cancer and IO monitoring, with breast cancer accepted for publication

•
Expanded the number of clinical studies in progress to over 20

•
Raised $50 million with Merck Sharp & Dohme LLC ("Merck") in a direct investment transaction

•
Signed a multi-year extension with ModernaTX, Inc. ("Moderna") to utilize ImmunoID NeXT for V940/mRNA-4157, an investigational individualized neoantigen therapy (INT) being jointly developed by Merck and Moderna

•
Expanded the commercial agreement with Tempus AI, Inc. ("Tempus") to authorize Tempus to sell NeXT Personal to pharmaceutical and biotechnology companies

"In 2024, we executed very well and are starting 2025 confident our strategy is working and we will "Win in MRD," said Chris Hall, Chief Executive Officer and President. "We expanded our partnership with Tempus, presented compelling clinical data at Medical Conferences, and drove testing growth 52% quarter over quarter ending the year with 1,441 molecular tests in the fourth quarter. Also, we announced a long-term commercial collaboration with Moderna and a strategic investment of $50 million from Merck, endorsing our technology platform and capabilities to support our partners’ initiatives, and providing a pathway to cashflow break-even."

Full Year 2024 Financial Results Compared with 2023

•
Revenue of $84.6 million for the full year of 2024 compared with $73.5 million, an increase of 15%

•
Revenue from pharma tests and services, enterprise sales, clinical diagnostics, and other customers of $77.2 million for the full year of 2024 compared with $64.1 million, an increase of 20%, despite the expected decrease in revenue from Natera of 20% to $25.4 million for the full year of 2024

•
Revenue from population sequencing for the VA MVP of $7.4 million for the full year of 2024, compared with $9.4 million, a decrease of 21%

•
Net loss of $81.3 million, and net loss per share of $1.37 based on a weighted-average basic and diluted share count of 59.3 million for the full year of 2024 compared with a net loss of $108.3 million, and net loss per share of $2.25 based on a weighted-average basic and diluted share count of 48.2 million

•
Cash, cash equivalents, and short-term investments of $185.0 million as of December 31, 2024; includes the $50.0 million strategic investment from Merck; reduced cash usage from operations and capital equipment additions in 2024 to $46.8 million, compared with $67.2 million

Fourth Quarter 2024 Financial Results Compared with 2023

•
Revenue of $16.8 million for the fourth quarter of 2024 compared with $19.7 million for the fourth quarter of 2023, a decrease of 15%, primarily due to the expected decline in revenue from Natera and the VA MVP

•
Pharma tests and services, enterprise sales, clinical diagnostics, and other customers of $16.6 million for the fourth quarter of 2024 compared with $18.7 million for the fourth quarter of 2023, a decrease of 11%

•
Population sequencing for the VA MVP of $0.2 million for the fourth quarter of 2024 compared with $1.0 million for the fourth quarter of 2023, a decrease of 78%

•
Net loss of $16.4 million, and net loss per share of $0.23 based on a weighted-average basic and diluted share count of 72.9 million in the fourth quarter 2024 compared with a net loss of $26.6 million, and net loss per share of $0.54 based on a weighted-average basic and diluted share count of 49.6 million in the fourth quarter of 2023

First Quarter and Full Year 2025 Outlook

Personalis expects the following for the first quarter of 2025:

•
Total company revenue to be in the range of $17 to $18 million

•
Revenue from pharma tests and services, and all other customers to be in the range of $10 to $11 million

•
Revenue from population sequencing and enterprise sales of approximately $7 million

Personalis expects the following for the full year of 2025:

•
Total company revenue in the range of $80 to $90 million

•
Revenue from pharma tests and services, and all other customers in the range of $62 to $64 million

•
Revenue from population sequencing and enterprise sales in the range of $15 to $16 million

•
Revenue from clinical tests reimbursed in the range of $3 to $10 million

•
Gross margin in the range of 21% to 23%, which is lower than the 32% gross margin for the full year of 2024 as we invest to drive clinical usage ahead of reimbursement.

•
Net loss of approximately $85 million

•
Cash usage in the range of $75 to $80 million, which is an increase from the $47 million used in 2024 primarily due to investments in the next phase of our "Win in MRD" strategy, inclusive of growing our test volume, expanding clinical studies, and investing in commercial capabilities to drive growth

Webcast and Conference Call Information

Personalis will host a conference call to discuss the fourth quarter and full year 2024 financial results, as well as plans for 2025, after market close on Thursday, February 27, 2025, at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time. The conference call can be accessed live by dialing 877-451-6152 for domestic callers or 201-389-0879 for international callers. The live webinar can be accessed at View Source A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company’s website.

Anaptys Announces Fourth Quarter and Full Year 2024 Financial Results and
Provides Business Update

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

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

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

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

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