On February 27, 2025 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, reported financial results for the fourth quarter and full year ended December 31, 2024, and provided a business update (Press release, Altimmune, FEB 27, 2025, View Source [SID1234650726]).

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"2024 was a year of important progress for Altimmune as we continued to advance pemvidutide in multiple indications," said Vipin K. Garg, Ph.D., President and Chief Executive Officer of Altimmune. "As announced previously, we completed enrollment of the IMPACT Phase 2b trial of pemvidutide in MASH and are on track to report top-line data in the second quarter of 2025. IMPACT was one of the fastest enrolling biopsy-driven Phase 2b MASH trials, which we believe reflects the attractiveness of pemvidutide to patients and providers, specifically the compound’s potent reduction of both liver fat and body weight. Based on the totality of the data generated to date, including multiple non-invasive biomarkers of liver inflammation and fibrosis, we are confident that pemvidutide will achieve statistically significant improvements in biopsy endpoints, both MASH resolution and fibrosis improvement, at trial readout. We anticipate holding an end-of-Phase 2 meeting with FDA by the end of 2025 to gain alignment on the registrational Phase 3 program."

Dr. Garg continued, "In-line with our previously stated plan, we submitted INDs for two additional indications in Q4 2024, and I am excited to report that both have received FDA clearance, and we are on track to initiate Phase 2 efficacy studies mid-2025. We look forward to providing information on these additional indications and our development plans during the upcoming virtual R&D Day on March 13. We believe that these indications reinforce our vision for the broad therapeutic utility of pemvidutide."

Recent Highlights and Anticipated Milestones

Metabolic Dysfunction-Associated Steatohepatitis (MASH)

IMPACT, the Company’s biopsy-driven Phase 2b trial of pemvidutide in MASH, is on track for top-line data readout in Q2 2025
IMPACT is evaluating the efficacy and safety of pemvidutide in approximately 190 subjects with biopsy-confirmed MASH.
With a successful readout from IMPACT, pemvidutide would be the first incretin to achieve statistical significance on MASH resolution and fibrosis improvement at only 24 weeks of treatment, and the first therapy in any class to achieve these endpoints along with meaningful weight loss at this timepoint.
Additional Indications for Pemvidutide

The Company submitted IND applications for pemvidutide in two additional indications at the end of 2024, both of which have been cleared by FDA
Phase 2 trials in additional indications are expected to initiate in mid-2025.
R&D Day March 13, 2025

Altimmune will hold a virtual R&D Day on Thursday, March 13, 2025 at 12:00pm Eastern Time
The program will feature presentations on pemvidutide development from Company management and key opinion leaders in obesity, MASH and the two additional indications which will be disclosed during the event.
Details of the R&D Day, including registration information, are available at View Source Additional information related to the event will be posted to this site.
Corporate Update

The Company strengthened its Board of Directors with the appointments of pharmaceutical industry veterans Teri Lawver and Jerry Durso
Ms. Lawver has nearly 30 years of experience spanning pharmaceuticals, medical devices and consumer health technology. She most recently served as Executive Vice President and Chief Commercial Officer of Dexcom. Previously she served for over 20 years at Johnson & Johnson in various leadership roles, including as Global Vice President for the Cardiovascular & Metabolism therapeutic area and Worldwide Vice President for the Immunology business at Janssen Pharmaceuticals.
Mr. Durso brings more than 30 years of leadership experience in the life sciences industry, most recently serving as Chief Executive Officer at Intercept Pharmaceuticals where he built a successful rare liver disease franchise and ultimately led the Company through its acquisition by Alfasigma. Prior to Intercept, he spent over two decades in a variety of leadership roles at Sanofi, including Chief Commercial Officer for its U.S. Pharmaceuticals business.
Financial Results for the Three Months Ended December 31, 2024

Altimmune reported cash, cash equivalents and short-term investments totaling $131.9 million on December 31, 2024.
Research and development expenses were $19.8 million for the three months ended December 31, 2024, compared to $16.9 million in the same period in 2023. The expenses for the quarter ended December 31, 2024, included $13.6 million in direct costs related to development activities for pemvidutide.
General and administrative expenses were $5.1 million for the three months ended December 31, 2024, compared to $4.3 million in the same period in 2023. The increase was primarily due to a $0.5 million increase in stock compensation.
Interest income was $1.6 million for the three months ended December 31, 2024, compared to $2.0 million for the same period in 2023.
Net loss for the three months ended December 31, 2024, was $23.2 million, or $0.33 net loss per share, compared to a net loss of $31.6 million, or $0.54 net loss per share, in the same period in 2023. The net loss for 2023 included the $12.4 million noncash impairment charge related to the discontinuation of development of HepTcell.
Financial Results for the Year Ended December 31, 2024

Research and development expenses were $82.2 million for the year ended December 31, 2024, compared to $65.8 million in the same period in 2023. The expenses for the year ended December 31, 2024, included $53.3 million in direct costs related to development activities for pemvidutide and $1.3 million in initial costs for additional research and discovery projects.
General and administrative expenses were $21.0 million for the year ended December 31, 2024, compared to $18.1 million in the same period in 2023. The increase was primarily due to a $2.7 million increase in stock compensation and other labor-related expenses, including the $1.0 million increase in stock compensation expense caused by modifications of stock awards.
Interest income was $8.1 million for the year ended December 31, 2024, compared to $7.4 million for the same period in 2023.
Net loss for the year ended December 31, 2024, was $95.1 million, or $1.34 net loss per share, compared to a net loss of $88.4 million, or $1.66 net loss per share, in the same period in 2023. The net loss for 2023 included the $12.4 million noncash impairment charge related to the discontinuation of development of HepTcell.
Conference Call Information:
Date: February 27, 2025
Time: 8:30 a.m. Eastern Time
Webcast: To listen, the conference call will be webcast live on Altimmune’s Investor Relations website at View Source
Dial-in: To participate or dial-in, register here to receive the dial-in numbers and unique PIN to access the call.

Following the conclusion of the call, the webcast will be available for replay on the Investor Relations (IR) page of the Company’s website at www.altimmune.com. The Company has used, and intends to continue to use, the IR portion of its website as a means of disclosing material non-public information and for complying with disclosure obligations under Regulation FD.

About Pemvidutide

Pemvidutide is a novel, investigational, peptide-based GLP-1/glucagon dual receptor agonist in development for the treatment of obesity and MASH. Activation of the GLP-1 and glucagon receptors is believed to mimic the complementary effects of diet and exercise on weight loss, with GLP-1 suppressing appetite and glucagon increasing energy expenditure. Glucagon is also recognized as having direct effects on hepatic fat metabolism, which is believed to lead to rapid reductions in levels of liver fat and serum lipids. In clinical trials to date, once-weekly pemvidutide has demonstrated compelling weight loss with class-leading lean mass preservation, and robust reductions in triglycerides, LDL cholesterol, liver fat content and blood pressure. The U.S. FDA has granted Fast Track designation to pemvidutide for the treatment of MASH. Pemvidutide recently completed the MOMENTUM Phase 2 obesity trial and is being studied in the ongoing IMPACT Phase 2b MASH trial.

On February 27, 2025 Medigene AG (Medigene, FSE: MDG1, Prime Standard) and EpimAb Biotherapeutics, Inc. (EpimAb), reported that the companies have entered a strategic co-development agreement to research and develop off-the-shelf T cell receptor (TCR)-guided T Cell Engagers (TCR-TCEs) for the treatment of immune-related disorders, such as solid tumors (Press release, MediGene, FEB 27, 2025, View Source [SID1234650725]).

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The multi-target collaboration combines the respective expertise of each company with Medigene’s 3S (sensitive, specific and safe) TCR generation and characterization capabilities and EpimAb’s proprietary CD3 antibody and T-FIT (TCR-Fab in tandem) platform. The resultant bispecific therapeutics are expected to provide highly specific targeted immune responses with minimized off-target effects and thus, improved patient outcomes.The companies aim to co-develop TCR-TCE constructs, which will be owned equally by both partners.

"We are delighted to partner with EpimAb and their proprietary T-FIT platform, which is well validated with strong clinical data and a number of prominent recent partnering deals, to develop potential best-in-class TCR-TCEs, leveraging our expert 3S TCR generation capabilities," said Selwyn Ho, CEO of Medigene AG. "This co-development agreement further expands the application of Medigene’s TCRs into off-the-shelf TCR-guided modalities and underscores our commitment to forging value-driven partnerships that expand our pipeline in areas of high unmet patient need."

"EpimAb is looking forward to discover new TCR-TCEs with Medigene’s unique TCRs," said Chengbin Wu, CEO and Founder of EpimAb. "Together we can open up new possibilities for our T-FIT and CD3 binding platforms to develop novel targeted therapies for cancer patients."

The market for bispecific therapies represents a significant opportunity in the fight against cancer, addressing the critical unmet need in both solid and hematologic tumors. Annually, over 5 million cancer patients worldwide, suffering from solid and hematologic cancers, face low five-year survival rates, highlighting the urgent demand for innovative treatments. Bispecific TCR-TCEs offer a promising solution, leveraging the body’s immune system to target and eradicate cancer cells with heightened precision.

The market for these therapies is projected to experience compound annual growth rate of 40.9% from 2023 to 2030, underscoring the robust and accelerating interest in this field. By 2030, the market is estimated to exceed USD80 billion (Source: KBV Research), reflecting its substantial potential to improve patient outcomes and revolutionize treatment of cancer and other diseases.

On February 27, 2025 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported financial results for the fourth quarter and full-year 2024, along with recent product highlights and corporate updates (Press release, Zai Laboratory, FEB 27, 2025, View Source [SID1234650721]).

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"2024 was a defining year for Zai Lab, marked by strong sales growth, financial strength, and significant pipeline progress. As we look ahead, 2025 is set to be a transformative year with VYVGART’s continued momentum, three new product launches, progress with ZL-1310, and potential regulatory milestones for key assets," said Dr. Samantha Du, Founder, Chairperson, and Chief Executive Officer of Zai Lab. "The VYVGART franchise generated $93.6 million in net product revenue in its exceptional first full year of launch, highlighting the strong demand for innovative therapies in China. With the recent acceptance of KarXT’s New Drug Application (NDA) by China’s National Medical Products Administration (NMPA) in January, we are one step closer to bringing this novel medicine to patients in need in China. Meanwhile, our global asset, ZL-1310, demonstrated strong safety and efficacy data, reinforcing its potential as a first- and best-in-class DLL3 antibody-drug conjugate (ADC) for the treatment of small cell lung cancer (SCLC). Zai Lab is stronger than ever, with the infrastructure, innovation, and execution needed to bring medicines to patients around the world and create value for our shareholders."

"Our total revenue for the fourth quarter and full-year 2024 grew 66% and 50% y-o-y, respectively, driven by the continued strong uptake of VYVGART along with continued growth in ZEJULA and NUZYRA sales," said Josh Smiley, President and Chief Operating Officer of Zai Lab. "Looking ahead, we expect substantial topline growth, targeting $2 billion in revenue by 2028, fueled by the VYVGART franchise for generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP) as well as upcoming potential blockbuster launches, including KarXT for schizophrenia and bemarituzumab for gastric cancer. Our innovative pipeline with global rights remains a key focus, with multiple data readouts expected this year and the potential for U.S. Food and Drug Administration (FDA) approval of ZL-1310 as early as 2027. Additionally, we significantly improved our financial position, delivering a substantial reduction in operating loss and advancing towards our goal of achieving profitability1 in the fourth quarter of 2025. With a robust cash position2, we are well-funded to reach this milestone while continuing to invest in high-impact growth opportunities."

Fourth Quarter and Full-Year 2024 Financial Results
•Product revenue, net was $108.5 million in the fourth quarter of 2024, compared to $65.8 million for the same period in 2023, representing 65% y-o-y growth at both actual exchange rate and constant exchange rate (CER); and was $397.6 million in full-year 2024, compared to $266.7 million for the same period in 2023, representing 49% y-o-y growth and 50% y-o-y growth at CER. This revenue growth was primarily driven by increased sales for VYVGART and was also supported by increased sales for ZEJULA and NUZYRA.

–VYVGART and VYVGART Hytrulo were $30.0 million in the fourth quarter of 2024, compared to $5.1 million for the same period in 2023; and was $93.6 million in full-year 2024, compared to $10.0 million for the same period in 2023. This growth was driven by increased sales of VYVGART since its launch in September 2023 and listing on China’s National Reimbursement Drug List (NRDL) for the treatment of gMG effective January 1, 2024.

–ZEJULA was $48.4 million in the fourth quarter of 2024, an increase of 16% y-o-y from $41.6 million; and was $187.1 million in full-year 2024, an increase of 11% y-o-y from $168.8 million. ZEJULA sales remained strong as it continued to be the leading PARP inhibitor in hospital sales for ovarian cancer in mainland China.

–NUZYRA was $11.0 million in the fourth quarter of 2024, an increase of 81% y-o-y from $6.1 million; and was $43.2 million in full-year 2024, an increase of 99% y-o-y from $21.7 million. This growth was supported by the inclusion in the NRDL for its IV formulation in January 2023 and its oral formulation in January 2024 for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and/or skin structure infections (ABSSSI). The NRDL listing for the IV formulation of NUZYRA was renewed in January 2025.

•Research and Development (R&D) expenses were $52.3 million in the fourth quarter of 2024, compared to $81.9 million for the same period in 2023; and were $234.5 million for full-year 2024, compared to $265.9 million for the same period in 2023. These decreases were primarily driven by the progress of existing studies, partially offset by increases in licensing fees.
•Selling, General and Administrative (SG&A) expenses were $82.6 million in the fourth quarter of 2024, flat compared to the same period in 2023. SG&A expenses were $298.7 million for full-year 2024, compared to $281.6 million for the same period in 2023, primarily due to higher general selling expenses related to the launch of VYVGART and growing sales for NUZYRA, partially offset by a decrease in selling expenses for other products and a decrease in general and administrative expenses.
•Loss from operations was $67.9 million and $282.1 million in the fourth quarter of 2024 and full-year 2024, respectively, $47.6 million and $199.6 million, respectively, when adjusted to exclude non-cash expenses, including depreciation, amortization, and share-based compensation. Loss from operations was $124.0 million and $366.6 million in the fourth quarter of 2023 and full-year 2023, respectively. A reconciliation of loss from operations (GAAP) to adjusted loss from operations (non-GAAP) is included at the end of this release.
•Net loss was $81.7 million in the fourth quarter of 2024, or a loss per ordinary share attributable to common stockholders of $0.08 (or loss per American Deposit Share (ADS) of $0.80), compared to a net loss of $95.4 million for the same period in 2023 or a loss per ordinary share of $0.10 (or loss per ADS of $0.98). The net loss was $257.1 million for full-year 2024, or a loss per ordinary share attributable to common stockholders of $0.26 (or loss per ADS of $2.60), compared to a net loss of $334.6 million for full-year 2023, or a loss per ordinary share of $0.35 (or loss per ADS of $3.46). These decreases in net loss were primarily due to product revenue growing faster than net operating expenses, offset by decreased interest income and increased foreign currency loss.
•Cash and cash equivalents, short-term investments and current restricted cash totaled $879.7 million as of December 31, 2024, compared to $806.5 million as of December 31, 2023.

2025 Strategic Priorities
Zai Lab will focus on the following strategic priorities in 2025 to drive innovation and growth in China and beyond:
Commercial Execution and Readiness
•Drive the ramp-up of VYVGART in gMG and VYVGART Hytrulo in gMG and CIDP through new patient acquisition and expansion of duration of treatment
•Maintain ZEJULA leadership position in ovarian cancer in China
•Prepare for launch of potential blockbuster products including bemarituzumab in gastric cancer and KarXT in schizophrenia
Clinical Development
•Rapidly advance the global Phase 1 study for ZL-1310 (DLL3 ADC with global rights) in SCLC and explore its potential in other neuroendocrine tumors
•Advance other assets with global rights including ZL-6201 (LRRC15 ADC) and ZL-1503 (IL-13/IL-31R) into Phase 1 development
•Within our regional immunology franchise, accelerate the clinical development of efgartigimod (FcRn), povetacicept (APRIL/BAFF), and ZL-1108 (IGF-1R) with several indications in registrational stage
Clinical Data and Regulatory Actions
•Data readouts for ZL-1310 (DLL3 ADC) in second-line+ and first-line SCLC
•Data readouts for Phase 3 studies of bemarituzumab in first-line gastric cancer; and potential Biologics License Application (BLA) submission to NMPA in the first half of 2025
•Potential NMPA submissions for Tumor Treating Fields (TTFields) in second-line+ non-small cell lung cancer (NSCLC) and first-line pancreatic cancer
2025 Guidance
Zai Lab expects continued rigorous financial discipline and:
•Total revenue to be in the range of $560 million to $590 million for full-year 2025
•On a non-GAAP basis, achieve profitability1 in the fourth quarter of 2025
Corporate Updates
Below are key corporate updates since our last earnings release:
•Business Development:
–We expanded and strengthened our global and regional pipelines through synergistic business development activities, including a strategic collaboration and worldwide license agreement with MediLink to use MediLink’s TMALIN ADC platform for the development of ZL-6201, a novel potential first-in-class LRRC15 ADC consisting of an antibody discovered by Zai Lab, for the treatment of certain solid tumors; a strategic collaboration with Vertex for the license of povetacicept, a potential best-in-class treatment for immunoglobulin A nephropathy (IgAN) and other B-cell mediated diseases, in mainland China, Hong Kong, Macau, Taiwan, and Singapore; and the license of ZL-1108, or veligrotug, a differentiated humanized monoclonal antibody targeting IGF-1R from Zenas BioPharma for the treatment of thyroid eye disease (TED) in mainland China, Hong Kong, Macau, Taiwan, and Singapore.
–We also entered into a strategic collaboration with Pfizer on the novel antibacterial drug XACDURO (Sulbactam-Durlobactam), which was launched in mainland China in January 2025. Through this collaboration, Zai Lab will leverage the industry-leading commercialization infrastructure of Pfizer’s affiliated companies in the anti-infective therapeutic area to help accelerate access to this important therapy for patients in need in mainland China.
•NRDL Updates: In November 2024, Zai Lab announced the inclusion of AUGTYRO (repotrectinib) for ROS1+ NSCLC as well as the successful renewals of NUZYRA (omadacycline) for CABP and ABSSSI and QINLOCK (ripretinib) for fourth-line+ gastrointestinal stromal tumor (GIST) patients in China’s NRDL.
•Capital Markets: In November 2024, Zai Lab completed a public offering of ADSs, which resulted in aggregate net proceeds to the Company of approximately $215.1 million, after deducting underwriting discounts and commissions and other offering expenses payable by the Company.
Recent Pipeline Highlights
Below are key product updates since our last earnings release:
Oncology Pipeline
•ZL-1310 (DLL3 ADC): In January 2025, the FDA granted Orphan Drug Designation to ZL-1310 for the treatment of SCLC. Receiving an Orphan Drug Designation for ZL-1310 reflects its potential to treat patients with SCLC, and ZL-1310 will be eligible for certain development incentives, including the potential to receive a seven-year U.S. market exclusivity period granted by the FDA upon product approval.
•Tumor Treating Fields (TTFields): In December 2024, Zai Lab and partner Novocure announced that the pivotal Phase 3 PANOVA-3 trial for pancreatic cancer met its primary endpoint, demonstrating a statistically significant improvement in median overall survival versus control group. PANOVA-3 is the first and only Phase 3 trial to demonstrate a statistically significant benefit in overall survival specifically in unresectable, locally advanced pancreatic cancer. Zai Lab participated in the study in Greater China and plans to file for regulatory approval in China in the second half of 2025.
•Tisotumab Vedotin (Tissue Factor ADC): In January 2025, Zai Lab announced positive topline results from the China subpopulation of the global Phase 3 innovaTV 301 study, demonstrating a clinically meaningful improvement in overall survival with TIVDAK treatment for patients with previously treated recurrent or metastatic cervical cancer compared to chemotherapy. Zai Lab plans to submit an NDA to the NMPA in the first quarter of 2025 and will leverage its commercial footprint of ZEJULA in women’s cancer to accelerate patient access to this therapy in China if approved.
•Repotrectinib (ROS1/TRK): In February 2025, China’s NMPA granted priority review to repotrectinib for the treatment of patients with advanced solid tumors that have an NTRK gene fusion. Zai Lab plans to submit a supplemental NDA to the NMPA in the first half of 2025.
Immunology, Neuroscience, and Infectious Disease Pipeline
•Efgartigimod (FcRn): In November 2024, Zai Lab partner argenx announced the decision to advance clinical development of the subcutaneous formulation of efgartigimod (efgartigimod SC) in the ongoing Phase 2/3 ALKIVIA study for the treatment of idiopathic inflammatory myopathies (IIM, or myositis), following analysis of topline data from the Phase 2 portion of the study. Zai Lab is participating in the study in Greater China.
•Xanomeline and Trospium Chloride (KarXT) (M1/M4-agonist): In January 2025, China’s NMPA accepted the NDA for KarXT for the treatment of schizophrenia in adults. If approved, KarXT has the potential to redefine the treatment landscape for patients with schizophrenia in mainland China.
Anticipated Major Milestones in 2025
Upcoming Potential NMPA Submissions
•Tisotumab Vedotin (Tissue Factor ADC): BLA submission in recurrent or metastatic cervical cancer following progression on or after chemotherapy in the first quarter of 2025.
•Bemarituzumab (FGFR2b): BLA submission in first-line gastric cancer in the first half of 2025.
•Repotrectinib (ROS1/TRK): supplementary NDA submission in NTRK+ solid tumors in the first half of 2025.
•Tumor Treating Fields (TTFields): Marketing Authorization Application submissions in second-line+ NSCLC following progression on or after platinum-based chemotherapy and in first-line pancreatic cancer.
Expected Clinical Developments and Data Readouts in 2025
Global Pipeline
ZL-1310 (DLL3 ADC)
•Second-Line+ Extensive-Stage SCLC (ES-SCLC): Zai Lab to present updated data at a major medical conference in the first half of 2025. Zai Lab plans to initiate a pivotal study in 2025.
•First-Line ES-SCLC: Zai Lab to provide data readout for dose escalation of ZL-1310 doublet in combination with atezolizumab and initiate dose escalation for ZL-1310 triplet in combination with atezolizumab and platinum-based chemotherapy.
•Other neuroendocrine tumors: Zai Lab to initiate a global Phase 1 study in the first half of 2025.
ZL-1102 (IL-17 Humabody)
•Zai Lab to provide interim analysis in the global Phase 2 study in chronic plaque psoriasis in the first half of 2025.
ZL-1503 (IL-13/IL-31R)
•Zai Lab to provide preclinical data update and initiate a global Phase 1 study in moderate-to-severe atopic dermatitis.
ZL-6201 (LRRC15 ADC)
•Zai Lab to provide preclinical data update and initiate a global Phase 1 study in sarcoma.
Regional Pipeline
Bemarituzumab (FGFR2b)
•Zai Lab partner Amgen to provide data readout from the Phase 3 FORTITUDE-101 study of bemarituzumab combined with chemotherapy versus chemotherapy alone in first-line gastric cancer in the first half of 2025. Zai Lab is participating in the study in Greater China.
•Zai Lab partner Amgen to provide data readout from the Phase 3 FORTITUDE-102 study of bemarituzumab plus chemotherapy and nivolumab versus chemotherapy and nivolumab in first-line gastric cancer in the second half of 2025. Zai Lab is participating in the study in Greater China.

Efgartigimod (FcRn)
•Seronegative gMG: Zai Lab partner argenx to provide topline results from the Phase 3 ADAPT-SERON study in seronegative gMG. Zai Lab participated in the study in Greater China.
•Lupus Nephritis (LN): Zai Lab to provide topline results from the Phase 2 study in LN.

Conference Call and Webcast Information

Zai Lab will host a live conference call and webcast today, February 27, 2025, at 8:00 a.m. ET (9:00 p.m. HKT). Listeners may access the live webcast by visiting the Company’s website at View Source Participants must register in advance of the conference call.
Details are as follows:
Registration Link: https://register.vevent.com/register/BI628d3dd054cb4c45b3d01b61fa5779b1
All participants must use the link provided above to complete the online registration process in advance of the conference call. Dial-in details will be in the confirmation email which the participant will receive upon registering.
A replay will be available shortly after the call and can be accessed by visiting the Company’s website.

On February 27, 2025 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immuno-oncology technologies addressing difficult to treat cancers, reported that its abstract has been accepted for poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Spring Scientific 2025 Cell Therapy Meeting being held March 12 – 14, 2025 in San Diego, CA and virtually (Press release, Xenetic Biosciences, FEB 27, 2025, View Source [SID1234650720]). 

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Details for the presentation are as follows:  

Abstract Number:  123
Title: DNase I Intervention Enhances CAR-T Cell Therapy in Solid Tumors by Targeting Neutrophil Extracellular Traps in Metastatic Melanoma
Presenter:  Alexey Stepanov, PhD, Institute Investigator at The Scripps Research Institute
Date & Time:  Wednesday, March 12, 2025 at 5:10 p.m. – 6:45p.m. PT

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.