On March 24, 2025 IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, reported that the U.S. Food and Drug Administration (FDA) is aligned with the protocol for the Phase 3 pivotal trial, called OVATION 3, of its lead candidate IMNN-001 in development for the treatment of women with newly diagnosed advanced ovarian cancer (Press release, IMUNON, MAR 24, 2025, View Source [SID1234651366]). The company is currently initiating trial sites and working with trial investigators to begin enrolling study participants.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are grateful for the ongoing guidance and support from the FDA and are very pleased that the agency is fully aligned on our plans related to the Phase 3 trial," said Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON. "The Phase 2 OVATION 2 study data are highly encouraging, demonstrating that IMNN-001 is the first immunotherapy to achieve a clinically effective response in ovarian cancer, including benefits in both progression-free and overall survival in frontline treatment, and we continue to observe strong improvements with additional monitoring and follow-up of patients. We look forward to potentially replicating these unprecedented results in the Phase 3 OVATION 3 study. We are currently initiating trial sites and are focused on enrolling study participants as quickly as possible as we work towards our goal of bringing thousands of women with advanced ovarian cancer a first-in-class and much-needed treatment option."

The Phase 3 OVATION 3 trial will assess the safety and efficacy of IMNN-001 (100 mg/m2 administered intraperitoneally weekly) plus neoadjuvant and adjuvant chemotherapy (NACT) of paclitaxel and carboplatin compared to standard of care (SoC) NACT alone. Study participants will be randomized 1:1 and include women with newly diagnosed advanced ovarian cancer (stage 3 or 4) who are eligible for neoadjuvant therapy, the intent-to-treat (ITT) population, with a sub-group of women positive for homologous recombination deficiency (HRD) including BRCA1 or BRCA2 mutations. Participants who are HRD positive will receive poly ADP-ribose polymerase (PARP) inhibitors as part of standard maintenance therapy. The primary endpoint of the study is overall survival (OS), and secondary endpoints are surgical response score, chemotherapy response score, clinical response and time to second-line treatment. The study will also assess several exploratory endpoints.

In December 2024, IMNN-001 plus NACT boosted median overall survival to 46 months—outpacing standard-of-care NACT by 13 months—up 2 months from the prior 11-month mark after 7 additional months of follow-up, with an excellent safety profile showing no cytokine release syndrome or serious adverse events. In the same month, the company also announced a positive outcome from a Type C Chemistry, Manufacturing, and Controls (CMC) meeting with the FDA regarding current good manufacturing practice (cGMP) production of IMNN-001 for the Phase 3 trial and potential commercialization. Production of IMNN-001 is conducted at IMUNON’s in-house manufacturing facility located in Huntsville, Alabama.

Conference Call and Webcast

IMUNON is hosting a conference call to discuss the Phase 3 OVATION 3 pivotal trial of IMNN-001 on Tuesday, March 25, 2025, at 2:00 p.m. ET. Company management will be joined by:

Premal H. Thaker, M.D., Interim Chief of Gynecologic Oncology, David & Lynn Mutch Distinguished Professor of Obstetrics & Gynecology, Director of Gynecologic Oncology Clinical Research at Washington University School of Medicine, and the OVATION 2 Study Chair
L.J. Wei, Ph.D., Professor of Biostatistics, Harvard T.H. Chan School of Public Health
To participate in the call, please dial 833-816-1132 (Toll-Free/North America) or 412-317-0711 (International/Toll) and ask for the IMUNON Phase 3 protocol call. A live webcast of the call will also be available here.

The call will be archived for replay until April 8, 2025. The replay can be accessed at 877-344-7529 (U.S. Toll-Free), 855-669-9658 (Canada Toll-Free) or 412-317-0088 (International Toll), using the replay access code 9074731. An audio replay of the call will also be available here for 90 days.

About the Phase 2 OVATION 2 Study

OVATION 2 evaluated the dosing, safety, efficacy and biological activity of intraperitoneal administration of IMNN-001 in combination with neoadjuvant and adjuvant chemotherapy (NACT) of paclitaxel and carboplatin in patients newly diagnosed with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer. Treatment in the neoadjuvant period is designed to shrink the tumors as much as possible for optimal surgical removal after three cycles of chemotherapy. Following NACT, patients undergo interval debulking surgery, followed by three additional cycles of adjuvant chemotherapy to treat any residual tumor. This open-label study enrolled 112 patients who were randomized 1:1 and evaluated for safety and efficacy to compare NACT plus IMNN-001 versus standard-of-care NACT. In accordance with the study protocol, patients randomized to the IMNN-001 treatment arm could receive up to 17 weekly doses of 100 mg/m2 in addition to NACT. As a Phase 2 study, OVATION 2 was not powered for statistical significance. Additional endpoints included objective response rate, chemotherapy response score and surgical response.

About IMNN-001 Immunotherapy

Designed using IMUNON’s proprietary TheraPlas platform technology, IMNN-001 is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system that enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anticancer immunity acting through the induction of T-lymphocyte and natural killer cell proliferation. IMUNON previously reported positive safety and encouraging Phase 1 results with IMNN-001 administered as monotherapy or as combination therapy in patients with advanced peritoneally metastasized primary or recurrent ovarian cancer and completed a Phase 1b dose-escalation trial (the OVATION 1 Study) of IMNN-001 in combination with carboplatin and paclitaxel in patients with newly diagnosed ovarian cancer. IMUNON previously reported positive results from the recently completed Phase 2 OVATION 2 Study, which assessed IMNN-001 (100 mg/m2 administered intraperitoneally weekly) plus neoadjuvant and adjuvant chemotherapy (NACT) of paclitaxel and carboplatin compared to standard-of-care NACT alone in 112 patients with newly diagnosed advanced ovarian cancer.

About Epithelial Ovarian Cancer

Epithelial ovarian cancer is the sixth deadliest malignancy among women in the U.S. There are approximately 20,000 new cases of ovarian cancer every year and approximately 70% are diagnosed in advanced Stage III/IV. Epithelial ovarian cancer is characterized by dissemination of tumors in the peritoneal cavity with a high risk of recurrence (75%, Stage III/IV) after surgery and chemotherapy. Since the five-year survival rates of patients with Stage III/IV disease at diagnosis are poor (41% and 20%, respectively), there remains a need for a therapy that not only reduces the recurrence rate, but also improves overall survival. The peritoneal cavity of advanced ovarian cancer patients contains the primary tumor environment and is an attractive target for a regional approach to immune modulation.

On March 24, 2025 Foghorn Therpaeutics presented its corporate presentation (Presentation, Foghorn Therapeutics, MAR 24, 2025, View Source [SID1234651365]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On March 24, 2025 Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for children and adults with cancer, reported the signing of a new Supply Agreement for copper-64 with UQ AIBN (Press release, Clarity Pharmaceuticals, MAR 24, 2025, View Source [SID1234651364]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The UQ AIBN Supply Agreement of copper-64 will support clinical trials with 64Cu-SAR-bisPSMA in Australia, offering this promising imaging agent to prostate cancer patients in need of novel diagnostic options. Additionally, the Agreement will support the rollout of 2 theranostic pre-clinical programs, 64/67Cu-SAR-bisFAP and 64/67Cu-SAR- trastuzumab.

With multiple clinical trials with 64Cu-SAR-bisPSMA, such as the ongoing registrational CLARIFY trial, Phase I/IIa theranostic SECuRE trial and the upcoming registrational Phase III AMPLIFY trial, as well as the Co-PSMA IIT, led by Prof Louise Emmett at St Vincent’s Hospital Sydney, the Agreement will provide additional capacity of copper-64 to ensure abundant and seamless supply of the isotope. The recent receipt of 2 Fast Track Designations (FTDs) by the US Food and Drug Administration (FDA) for the diagnostic 64Cu-SAR-bisPSMA product1,2 will enable Clarity to accelerate the development of its program with this optimised agent in the pre-prostatectomy setting as well as in patients with biochemical recurrence (BCR) of prostate cancer. The granting of these FTDs is indicative of the high unmet need in prostate cancer imaging despite the use of first-generation PSMA products in the market and is testament to the high quality of science and data Clarity is generating with this product.

64Cu-SAR-bisPSMA differentiates itself from the current generation of radio-diagnostics in 2 distinct ways. Firstly, the dimer "bis" molecule enables increased uptake and retention of the imaging agent in tumours3,4. Similar to Clarity’s platform SAR Technology, it has been developed in Australia, at the benchtop of Australian science, with the intent of overcoming the shortfalls of the current generation of prostate-specific membrane antigen (PSMA) targeting products. The clinical data that Clarity has generated to date confirms these results initially seen in preclinical development3,4. The second advantage is associated with the benefits of the copper-64 isotope, which has a half-life much longer (12.7 hours) than that of gallium-68 and fluorine-18 (less than 2 hours). This enables next-day imaging, a feature not available with the current-generation radio-diagnostics. Clarity’s clinical trials with 64Cu-SAR-bisPSMA to date have demonstrated a number of benefits of next-day imaging. In the Phase II COBRA study, next-day 64Cu-SAR-bisPSMA imaging enabled detection of lesions in up to 80% of participants in comparison to up to 58% on the same-day imaging, and the number of lesions detected on the next-day scans almost doubled in comparison to the same-day scans5.

In addition to the clinical benefits, the longer half-life of copper-64 enables manufacturing and logistical advantages. While the current-generation of radio-diagnostics require an expensive and extensive network of cyclotrons, radioisotope generators and radiopharmacies next to imaging sites due to their short half-life, resulting in a short shelf-life, copper-64 can be centrally produced in large volumes on existing cyclotrons. Copper-64 based diagnostics can then be manufactured and shipped as finished drug products to any treatment facility in the country, overcoming the many issues with product shortage and expiry, patient scheduling and limited geographic distribution of the current generation of products. Products like PYLARIFY are already hitting supply limits in the US due to limited cyclotron availability and the competing use of fluorine-18, which is prioritised for fluorodeoxiglucose (FDG). In contrast, copper-64 can be made on the same cyclotrons as fluorine-18, such as that at UQ AIBN, but at different times to fluorine-18, which has to be manufactured strictly in the morning in order to deliver it to patients before the half-life expires.

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, "We are pleased to continue building a successful Australian life-sciences story and benefiting Australian patients and their treating clinicians. We are proud to have been able to progress our technology from the benchtop at some of the most prominent institutes in Australia to Phase III trials at leading clinical sites in Australia and the US. This agreement with the UQ AIBN not only builds on years of close ties between Clarity and the Australian scientific and clinical communities but also reflects our strong focus on continued partnership and synergies that can be derived from these important collaborations. We are dedicated to continuing to work with the leading research and development (R&D) organisations in Australia and giving back to the scientific and clinical community in our country in order to get closer to our ultimate goal of improving treatment outcomes for people with cancer.

"UQ advanced imaging has been a long-standing collaborator of Clarity through a number of R&D initiatives, including being an active participant in the ARC Hub for AMTAR. We have experienced first-hand the strong scientific focus, drive for innovation and the collaborative community and look forward to continuing working together to bring novel products to patients in need of better diagnostic and treatment options.

"The AIBN houses an on-site cyclotron and state-of-the-art radiochemistry facilities, supplying copper-64 every week. Securing a strong supply chain is pivotal as we ramp up our clinical trials and look to generate sufficient data for the approval of 64Cu-SAR-bisPSMA. This centralised distribution strategy with the AIBN supplying copper-64 for the manufacturing of our innovative 64Cu-SAR-bisPSMA diagnostic agent will ensure that patients and clinicians have secure and seamless access to the product as we continue to generate exciting data in our trials.

"We are also committed to exploring new ways in which we can leverage our unique advantages in the development of Targeted Copper Theranostics (TCTs) to bring new products for indications with high unmet needs. As such, the Supply Agreement will also support the recently announced development of SAR-bisFAP and SAR-trastuzumab theranostic programs."

About SAR-bisPSMA
SAR-bisPSMA derives its name from the word "bis", which reflects a novel approach of connecting two PSMA-targeting agents to Clarity’s proprietary sarcophagine (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-bisPSMA is a Targeted Copper Theranostic (TCT) that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.

67Cu-SAR-bisPSMA and 64Cu-SAR-bisPSMA are unregistered products. The safety and efficacy of 67Cu-SAR-bisPSMA and 64Cu-SAR-bisPSMA have not been assessed by health authorities such as the US FDA or the Therapeutic Goods Administration (TGA). There is no guarantee that these products will become commercially available.

On March 24, 2025 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for a key patent application covering its ovarian cancer vaccine technology (Press release, Anixa Biosciences, MAR 24, 2025, View Source [SID1234651361]). The patent includes broad claims related to methods of eliciting an immune response targeting Anti-Mullerian Hormone Receptor, Type II (AMHR2), a promising target for ovarian cancer prevention and treatment.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Anixa’s ovarian cancer vaccine, being developed in collaboration with Cleveland Clinic and the National Cancer Institute, represents a novel approach to preventing and treating ovarian cancer, particularly among high-risk populations such as those carrying BRCA mutations or with a family history of the disease.

The allowed claims include methods of administering an immunogenic composition comprising a nucleic acid encoding the AMHR2 polypeptide, specifically the extracellular domain of human AMHR2, to elicit an AMHR2-specific immune response.

Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences, commented, "Receiving this Notice of Allowance from the USPTO is a significant milestone in our mission to develop a preventative and therapeutic ovarian cancer vaccine. The allowed claims provide broad protection for the various components and delivery mechanisms of our vaccine technology. This strengthens our intellectual property position and supports the continued advancement of our program."

On March 24, 2025 Adagene Inc. ("Adagene") (Nasdaq: ADAG), a platform-driven, clinical-stage biotechnology company transforming the discovery and development of novel anti-body-based therapies, reported financial results for the full year 2024 and provided corporate updates (Press release, Adagene, MAR 24, 2025, View Source [SID1234651360]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The clinical data we generated in 2024 with ADG126 gives us great confidence in our ability to provide patients with colorectal cancer a tolerable, efficacious treatment option. These data also provide the basis for us to expand our study in microsatellite stable colorectal cancer (MSS CRC) to include earlier lines of therapy and patients with liver metastases, a patient subpopulation that has historically seen little to no benefit from checkpoint inhibitors," said Peter Luo, Ph.D., Chairman, CEO and President of R&D at Adagene. "Regulatory T cells, a primary mechanism of resistance, can be overcome through higher and more frequent dosing of a conditionally active anti-CTLA-4 antibody. We continue to believe that ADG126 can transform immunotherapy in combination with anti-PD-1 and other therapies. Our SAFEbody masking capability enables the best therapeutic index among all CTLA-4 programs, showing the potential to unlock therapeutic value with a target previously limited by safety concerns."

Dr. Luo continued, "In addition to ADG126, we have also utilized our SAFEbody masking technology to create T cell engagers (TCEs) that can link T cells to any number of antigens presented on tumor cells. These masked TCEs can recruit the immune system for conditional cytotoxicity, shrinking tumors and prolonging patient survival. The combination of TCEs with ADG126, which depletes CTLA-4 mediated regulatory T cells, is expected to enhance the response to TCE therapy. We look forward to sharing more on our TCE programs going forward."

PIPELINE HIGHLIGHTS

ADG126 – Phase 1b/2 data:

· 20 mg/kg loading dose followed by 10 mg/kg Q3W in combination with pembrolizumab, Merck’s (known as MSD outside of the US and Canada) anti-PD-1 therapy, KEYTRUDA (pembrolizumab), cohort achieved an improved ORR of 33%.

o All responders remain on treatment at a maintenance dose of 10 mg/kg Q3W or 10 mg/kg Q6W in combination with pembrolizumab

· Good tolerability with a manageable safety profile for ADG126 + pembrolizumab combo, with overall low discontinuation rate (6%) for the MSS CRC expansion cohort. No Grade 4/5 safety events were seen to date.

· Based on robust safety data of ADG126 at 20 mg/kg Q6W in combination with pembrolizumab, the efficacy of this dosing regimen is being evaluated in the cohort expansion stage of the Phase 1b/2 trial.

· Company also plans to evaluate a broader patient population, including patients with liver metastases, by combining with standard of care medicines, a combination that has been limited by safety concerns in the past.

· Investigator initiated Phase 2 trial of ADG126 in neoadjuvant colorectal cancer to begin enrolling patients in April at the National University Cancer Institute in Singapore

ADG138, a SAFEbody engineered T cell engager targeting HER2, has shown a wide therapeutic window and extended half-life for prolonged circulation in the tumor micro-environment in preclinical models. ADG138 is currently IND-ready.

ADG152, a SAFEbody engineered T cell engager targeting CD20, is designed to conditionally bind to CD20 on tumor cells and show negligible interaction with healthy cells, yielding a 100-fold reduction in cytokine release syndrome in preclinical models. ADG152 is currently in the IND-enabling phase.

The Company is pursuing strategic partnerships to advance the SAFEbody T cell engager programs.

ONGOING COLLABORATIONS

Exelixis: In June 2023, Adagene received a US$3.0 million milestone payment from Exelixis for the successful nomination of lead SAFEbody candidates for the second collaboration program under a technology licensing agreement to develop novel masked antibody-drug conjugate candidates. Including upfront and other milestone payments, we have received over US$18 million in total from Exelixis to date.

Sanofi: Adagene and Sanofi are collaborating to develop both bispecific and monoclonal SAFEbody antibody candidates, preparing preclinical candidates using Adagene’s SAFEbody precision masking technology for future development and commercialization by Sanofi. The collaboration announced in March 2022 included an upfront payment of US$17.5 million for the initial two programs, an option fee for two additional programs, potential milestone payments of up to US$2.5 billion, and tiered royalties.

Roche: Roche is sponsoring and conducting a phase 1b/2 multi-national trial to evaluate ADG126 in a triple combination with atezolizumab and bevacizumab in first-line hepatocellular carcinoma (HCC). To date, the combination has been well tolerated. Adagene retains global development and commercialization rights to ADG126.

2025 MILESTONES & CASH RUNWAY

Consistent with ongoing initiatives to prudently manage its cash balance, Adagene expects its current cash balance to fund activities into late 2026, with the following milestones expected in 2025:

· Provide longer-term time-to-event data from the existing Ph 1b/2 study of ADG126 + pembrolizumab in 3L+ MSS CRC

· Update 20 mg/kg loading dose cohort for durability of response (DOR and other time-to-event endpoints)

· Conduct EOP1 meeting with FDA by Q3 to obtain their endorsement on the proposed dose regimens, trial design and patient population

· Initiate evaluation of ADG126 + pembrolizumab in combination with standard of care in MSS CRC patients including those with liver metastases, beginning Q2

· Provide initial clinical data from investigator initiated Phase 2 trial for neoadjuvant ADG126 in colorectal cancer

· Establish additional collaboration/licensing agreements

CORPORATE UPDATES

JC Xu, M.D., Ph.D., Adagene’s Chief Strategy Officer and Head of Regulatory Affairs, has recently transitioned from a full-time employee of Adagene to a consulting role. JC will continue to support the Company’s development while serving as a consultant.

Ms. Yumeng Wang, a member of Adagene’s Board of Directors and a Vice President at General Atlantic, will step down from the Board upon filing of the Company’s 2024 Annual Report on form 20-F due to personal reason. Ms. Wang has served on Adagene’s Board since 2023 and provided invaluable guidance as Adagene has developed ADG126 through first-in-human clinical trials.

Mervyn Turner, Ph.D., Independent Director of Adagene’s Board of Directors, will complete his term as Independent Director concurrent with the filing of the Company’s 2024 Annual Report on form 20-F, and transition to an advisory role. Mr. Turner has served on Adagene’s Board of Directors since April of 2023 and will continue to provide strategic guidance to the Company in this advisory capacity.

FINANCIAL HIGHLIGHTS

Cash and Cash Equivalents:

Cash and cash equivalents were US$85.2 million as of December 31, 2024, compared to US$109.9 million as of December 31, 2023. Total borrowings from commercial banks in China (denominated in RMB) decreased to US$18.2 million as of December 31, 2024 from US$21.9 million as of December 31, 2023. The associated loan proceeds were primarily used to support the company’s R&D activities.

Net Revenue:

Net revenue was US$0.1 million for the year ended December 31, 2024, compared to US$18.1 million in 2023.

Research and Development (R&D) Expenses:

R&D expenses were US$28.8 million for the year ended December 31, 2024, compared to US$36.6 million in 2023. The decrease of approximately 21% in R&D expenses reflects clinical focus on and prioritization of the company’s masked, anti-CTLA-4 SAFEbody ADG126.

Administrative Expenses:

Administrative expenses were US$7.3 million for the year ended December 31, 2024, compared to US$8.7 million in 2023. The decrease was due to both a reduction in personnel and in office-related expenses as a result of cost-control measures.

Other Operating Income, Net:

Other operating income, net was nil for the year ended December 31, 2024 compared to US$3.5 million in 2023. The amount of US$3.5 million included a one-time compensation payment from a contract manufacturer for a preclinical-related outsourcing arrangement.

Net Loss:

Net loss attributable to Adagene Inc.’s shareholders was US$33.4 million for the year ended December 31, 2024, compared to US$18.9 million in 2023.

Ordinary Shares Outstanding:

As of December 31, 2024, there were 58,886,944 ordinary shares issued and outstanding. Each American depository share, or ADS, represents one and one quarter (1.25) ordinary shares of the company.

Non-GAAP Net Loss:

Non-GAAP net loss, which is defined as net loss attributable to ordinary shareholders for the period after excluding share-based compensation expenses, was US$28.5 million for the year ended December 31, 2024, compared to US$11.7 million in 2023. Please refer to the section in this press release titled "Reconciliation of GAAP and Non-GAAP Results" for details.