On February 27, 2025 GENFIT (Nasdaq and Euronext: GNFT), a biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, reported its cash position as of December 31, 2024 and revenues for 2024 (Press release, Genfit, FEB 27, 2025, https://ir.genfit.com/news-releases/news-release-details/genfit-announces-revenues-and-cash-position-december-31-2024 [SID1234650702]).

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Cash Position

As of December 31, 2024, the Company’s cash and cash equivalents amounted to €81.8 million compared with €77.8 million as of December 31, 2023 and €96.0 million as of September 30, 2024.

In 2024, cash utilization is mainly the result of our research and development efforts in our ACLF franchise (notably VS-01, NTZ, SRT-015, CLM-022, and VS-02 HE), as well as GNS561 in cholangiocarcinoma (CCA). Cash utilization is offset notably by the €48.7 million milestone received in August 2024 (invoiced in June 2024) upon first sale of Ipsen’s Iqirvo (elafibranor) in the U.S. for the treatment of PBC, as part of our long-term strategic partnership with Ipsen (the "Ipsen agreement") signed in December 2021.

As announced on January 30, 2025, Genfit has signed a royalty financing deal providing up to €185 million non-dilutive capital, enabling us to fund our operating expenses and capital expenditure requirements beyond the end of 2027. This is based on current assumptions and programs and does not include exceptional events. This estimation assumes i) our expectation to receive significant future milestone revenue in 2025, including the €26.55 million milestone pending a third pricing and reimbursement approval of Iqirvo (elafibranor) in a major European market and Ipsen meeting its sales-based thresholds, ii) the closing of the royalty financing and the drawing down all instalments thereunder, and iii) the repurchase of the OCEANEs following such closing or their reimbursement at maturity in October 2025. Note that the closing of the royalty financing remains subject to the approval of the OCEANE bondholders at a bondholders general meeting convened for March 10, 2025, as announced on February 21, 2025, and the satisfaction of other customary closing conditions.

Revenues

Revenues for 2024 amounted to €67.0 million compared to €28.6 million for the same period in 2023.

Of the €67.0 million, €48.7 million was attributable to a milestone payment invoiced to Ipsen in June 2024 and €2.7 million was attributable to royalty revenue from U.S. sales of Iqirvo/elafibranor which commenced mid-June in application of the Ipsen Agreement signed in December 2021. €15.3 million in revenue was attributable to the partial recognition of deferred income of €40 million accounted for in accordance with IFRS 15, in application of the aforementioned licensing agreement. €0.1 million in revenue was generated from the services rendered under the Transition Services Agreement and Part B Transition Services Agreement, signed in April 2022 and September 2023 respectively by GENFIT and Ipsen, in order to facilitate the transition of certain services related to the Phase 3 ELATIVE clinical trial until the complete transfer of the responsibility of the trial to Ipsen. €0.2 million was attributable to other ancillary activities.

Of the €28.6 million revenues in 2023, €13.3 million was attributable to a milestone payment invoiced to Ipsen in December 2023 in accordance with the Ipsen Agreement signed in December 2021. This milestone payment was earned following the New Drug Application filing acceptance by the U.S. Food and Drug Administration and Marketing Authorization Application filing acceptance by the European Medicines Agency for accelerated approval of elafibranor. €8.7 million in revenue was attributable to the partial recognition of the €40.0 million deferred income as described above. €6.5 million in revenue was generated from the services rendered under the Transition Services Agreement and Part B Transition Services Agreement, signed in April 2022 and September 2023 respectively by GENFIT and Ipsen as described above. €0.1 million was attributable to other ancillary activities.

Upcoming Financial Communications

The Company will release its full-year 2024 financial results on April 24, 2025. The 2024 Universal Registration Document, the 2024 Annual Financial Report (included in the 2024 Universal Registration Document), and the Annual Report on Form 20-F will be published by the end of April 2025.

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 Heron Therapeutics, Inc. (Nasdaq: HRTX) ("Heron" or the "Company"), a commercial-stage biotechnology company, reported financial results for the three and twelve months ended December 31, 2024, and highlighted recent corporate updates (Press release, Heron Therapeutics, FEB 27, 2025, View Source [SID1234650703]).

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"2024 was a milestone year for Heron. We delivered strong financial results, including positive Net Income for Q4 2024, achieved our operational objectives, and repositioned the business for future growth. As we move into 2025, our product ZYNRELEF is poised for transformational growth, driven by its expanded label indications, the launch of the VAN, the approval of the NOPAIN Act, and the enhanced promotional reach of the Crosslink relationship," said Craig Collard, Chief Executive Officer.

Financial Guidance for 2025

Item

2025 Full-Year Guidance for Net Revenue and Adjusted EBITDA

(in millions)

Net Revenue

$153.0

to

$163.0

Adjusted EBITDA

$0.0

to

$8.0

Business Highlights

Partnership with Crosslink Network, LLC ("Crosslink") expands the promotional effort for ZYNRELEF within the orthopedic surgery marketplace for post-operative pain.

Expanded label indications for ZYNRELEF now cover an estimated 17 million annual targeted procedures with many more also indicated – a significant increase over prior indicated procedures, based upon data from studies for cesarean section, spinal surgery, augmentation mammoplasty, and total shoulder arthroplasty, making ZYNRELEF appropriate for a wide range of patients and appealing for broad formulary adoption.

ZYNRELEF will continue to receive separate payment from April 1, 2025, until at least the end of 2027 as the result of inclusion in the "CMS OPPS and ASC Final Rule CY 2025 Non-Opioid Policy for Pain Relief" by the Centers for Medicare & Medicaid Services ("CMS").

The ZYNRELEF VAN launched in Q4 2024, following approval by the U.S. Food and Drug Administration ("FDA") in September 2024. The VAN replaces the current vented vial spike and is expected to simplify aseptic preparation, while also significantly reducing ZYNRELEF’s withdrawal time to between twenty and forty-five seconds.

Cash, cash equivalents, and short-term investments were $59.3 million as of December 31, 2024.
Net Revenue Performance – Year Ended December 31

2024

2023

Dollar Change

Percentage Change

Acute Care

$30,064

$19,118

$10,946

57.3 %

APONVIE

$4,518

$1,391

$3,127

224.8 %

ZYNRELEF

$25,546

$17,727

$7,819

44.1 %

Oncology

$114,221

$107,926

$6,295

5.8 %

CINVANTI

$100,079

$94,869

$5,210

5.5 %

SUSTOL

$14,142

$13,057

$1,085

8.3 %

Total Net Revenue

$144,285

$127,044

$17,241

13.6 %

Net Revenue Performance – Quarter Ended December 31

2024

2023

Dollar Change

Percentage Change

Acute Care

$10,389

$6,164

$4,225

68.5 %

APONVIE

$1,932

$470

$1,462

311.1 %

ZYNRELEF

$8,457

$5,694

$2,763

48.5 %

Oncology

$30,392

$28,070

$2,322

8.3 %

CINVANTI

$26,873

$24,270

$2,603

10.7 %

SUSTOL

$3,519

$3,800

(281)

-7.4 %

Total Net Revenue

$40,781

$34,234

$6,547

19.1 %

Conference Call and Webcast

Heron will host a conference call and live webcast on Thursday, February 27, 2025, at 8:00 a.m. ET. The conference call can be accessed by phone by utilizing the following registration link which will provide participants with dial-in details. To avoid delays, we encourage participants to dial into the conference call fifteen minutes ahead of the scheduled start time. The conference call will also be available via webcast under the Investor Relations section of Heron’s website at www.herontx.com. An archive of the teleconference and webcast will also be made available on Heron’s website for sixty days following the call.

About ZYNRELEF for Postoperative Pain

ZYNRELEF is the first and only dual-acting local anesthetic that delivers a fixed-dose combination of the local anesthetic bupivacaine and a low dose of nonsteroidal anti-inflammatory drug meloxicam. ZYNRELEF is the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and significantly increased proportion of patients requiring no opioids through the first 72 hours following surgery compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. ZYNRELEF was initially approved by the FDA in May 2021 for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty. In December 2021, the FDA approved an expansion of ZYNRELEF’s indication to include foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures. On January 23, 2024, the FDA approved ZYNRELEF for soft tissue and orthopedic surgical procedures including foot and ankle, and other procedures in which direct exposure to articular cartilage is avoided. Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel spinal, and head and neck procedures.

Please see full prescribing information, including Boxed Warning, at www.ZYNRELEF.com.

About APONVIE for Postoperative Nausea and Vomiting (PONV)

APONVIE is a substance NK1 Receptor Antagonist (RA), indicated for the prevention of PONV in adults. Delivered via a 30-second IV push, APONVIE 32 mg was demonstrated to be bioequivalent to oral aprepitant 40 mg with rapid achievement of therapeutic drug levels. APONVIE is the same formulation as Heron’s approved drug product CINVANTI. APONVIE is supplied in a single-dose vial that delivers the full 32 mg dose for PONV. APONVIE was approved by the FDA in September 2022 and became commercially available in the U.S. on March 6, 2023.

Please see full prescribing information at www.APONVIE.com.

About CINVANTI for Chemotherapy Induced Nausea and Vomiting (CINV) Prevention

CINVANTI, in combination with other antiemetic agents, is indicated in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin as a single-dose regimen, delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) as a single-dose regimen, and nausea and vomiting associated with initial and repeat courses of MEC as a 3-day regimen. CINVANTI is an IV formulation of aprepitant, an NK1 RA. CINVANTI is the first IV formulation to directly deliver aprepitant, the active ingredient in EMEND capsules. Aprepitant (including its prodrug, fosaprepitant) is a single-agent NK1 RA to significantly reduce nausea and vomiting in both the acute phase (0–24 hours after chemotherapy) and the delayed phase (24–120 hours after chemotherapy). The FDA-approved dosing administration included in the U.S. prescribing information for CINVANTI include 100 mg or 130 mg administered as a 30-minute IV infusion or a 2-minute IV injection.

Please see full prescribing information at www.CINVANTI.com.

About SUSTOL for CINV Prevention

SUSTOL is indicated in combination with other antiemetics in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens. SUSTOL is an extended-release, injectable 5-hydroxytryptamine type 3 RA that utilizes Heron’s Biochronomer drug delivery technology to maintain therapeutic levels of granisetron for ≥5 days. The SUSTOL global Phase 3 development program was comprised of two, large, guideline-based clinical studies that evaluated SUSTOL’s efficacy and safety in more than 2,000 patients with cancer. SUSTOL’s efficacy in preventing nausea and vomiting was evaluated in both the acute phase (0–24 hours after chemotherapy) and delayed phase (24–120 hours after chemotherapy).

Please see full prescribing information at www.SUSTOL.com.

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
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A replay will be available shortly after the call and can be accessed by visiting the Company’s website.

On February 27, 2025 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, reported its financial results for the fourth quarter and full year ended 2024 and provided a corporate update (Press release, Aclaris Therapeutics, FEB 27, 2025, View Source [SID1234650685]).

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"2024 was a transformative year that has positioned Aclaris with multiple clinical catalysts expected in 2025 across our expanded pipeline," stated Dr. Neal Walker, Chief Executive Officer and Chair of the Board of Directors of Aclaris. "We are particularly excited about the upcoming Phase 2 data for bosakitug in both severe asthma and chronic rhinosinusitis with nasal polyps anticipated from our partner CTTQ, which we expect will provide important insights into our future development of bosakitug in respiratory diseases. We also anticipate top-line data from our Phase 2a trial of ATI-2138 in atopic dermatitis in the first half of 2025. With multiple clinical catalysts expected throughout 2025 across our pipeline of differentiated assets with mechanisms shown to have proven activity in the diseases we are addressing, we look to drive continued innovation for the patients we seek to treat."

Fourth Quarter 2024 Highlights and Recent Updates

Pipeline:

Announced Exclusive, Global License Agreement with Biosion, Inc., Adding Potential Best-in-Class Biologic Assets to Pipeline: Aclaris acquired worldwide rights (excluding Greater China) to bosakitug (ATI-045), a potential best-in-class, clinical-stage, novel anti-TSLP monoclonal antibody, and ATI-052, a potential best-in-class, pre-clinical stage, novel bispecific antibody that is directed against both TSLP and IL4R. As a result of this license agreement, the Company recorded a one-time $86.9 million in-process research and development charge. (press release here)
Confirmed Expectation of Phase 2 Data in the First Half of 2025 for Bosakitug in Chinese Patients with Certain Pulmonary Disorders: Aclaris’ regional partner, Chia Tai Tianqing Pharmaceutical Group, Co., Ltd. (CTTQ), is conducting concurrent Phase 2 studies in China for patients with severe asthma, CRSwNP, and chronic obstructive pulmonary disease. Data from trials in severe asthma and CRSwNP expected in first half of 2025 to inform internal development programs.
Initiated Clinical Trial Activities for a Phase 2b Trial of Bosakitug in Atopic Dermatitis (AD); Enrollment Expected to Begin in the First Half of 2025: This trial will investigate the safety, tolerability, pharmacokinetics, efficacy, and pharmacodynamics of bosakitug in patients with moderate to severe AD.
Confirmed Expectation of Top Line Results in the First Half of 2025 for Phase 2a Trial in AD of ATI-2138, an Investigational Oral Covalent ITK/JAK3 Inhibitor: This ongoing Phase 2a open-label trial is being conducted to investigate the safety, tolerability, pharmacokinetics, efficacy, and pharmacodynamics of ATI-2138 in patients with moderate to severe AD.
Announced Plan to File an Investigational New Drug (IND) Application for ATI-052 in the First Quarter of 2025: Following allowance of the IND, Aclaris expects to initiate a Phase 1 clinical trial evaluating single ascending doses and multiple ascending doses of ATI-052.
Announced New Publication Highlighting the Unique Properties of ATI-2138: New publication provides important clinical and non-clinical evidence of the potential for ATI-2138 to be a best-in-class inhibitor of key signal transduction kinases due to its unique mechanism of action. (press release here)
Corporate:

Completed $80 Million Private Placement in November 2024 to Bolster Cash Runway: Aclaris’ cash runway expected into 2028. (press release here)
Provided Update on Senior Leadership:
Dr. Neal Walker, formerly interim Chief Executive Officer, has been named Chief Executive Officer. Dr. Walker is a co-founder of Aclaris and has served as a member of the Board of Directors since its inception. He previously served as Aclaris’ Chief Executive Officer until 2022 before being appointed as interim Chief Executive Officer in January 2024. Dr. Walker serves as Chair of the Board of Directors of Aclaris.
Hugh Davis, Ph.D. joined Aclaris as President and Chief Operating Officer. Dr. Davis brings over 35 years of experience in biologics development, clinical pharmacology, and business development to Aclaris. He most recently served as Biosion’s Chief Business & Development Officer and President.
William Roberts has been appointed as Senior Vice President, Corporate Communications and Investor Relations. Mr. Roberts brings 30 years of corporate communications, investor relations, and scientific experience in the biotech/biopharma industry to the Company. He most recently served as the Communications Officer of G1 Therapeutics, which was recently acquired by Pharmacosmos Group.
Fourth Quarter and Full Year 2024 Financial Results

As of December 31, 2024, Aclaris had aggregate cash, cash equivalents and marketable securities of $203.9 million compared to $181.9 million as of December 31, 2023. The Company believes that its cash, cash equivalents and marketable securities as of December 31, 2024 will be sufficient to fund its operations into 2028, without giving effect to any potential business development transactions or financing activities.

Net loss was $96.6 million for the fourth quarter of 2024 compared to $1.5 million for the fourth quarter of 2023. Net loss was $132.1 million for the year ended December 31, 2024 compared to $88.5 million for the year ended December 31, 2023.

Total revenue was $9.2 million for the fourth quarter of 2024 compared to $17.6 million for the fourth quarter of 2023. The decrease was primarily driven by a one-time upfront payment under the license agreement with Sun Pharmaceutical Industries, Inc. received in the fourth quarter of 2023, offset by the achievement of a commercial milestone under the license agreement with Eli Lilly and Company in the fourth quarter of 2024. Total revenue was $18.7 million for the year ended December 31, 2024 compared to $31.2 million for the year ended December 31, 2023.

Research and development (R&D) expenses were $9.0 million for the quarter ended December 31, 2024 compared to $26.6 million for the prior year period. The $17.6 million decrease was primarily the result of lower zunsemetinib development expenses, lepzacitinib preclinical and clinical development activities, and compensation-related expenses. For the year ended December 31, 2024, R&D expenses were $33.6 million compared to $98.4 million for the year ended December 31, 2023.

General and administrative (G&A) expenses were $5.0 million for the quarter ended December 31, 2024 compared to $8.2 million for the corresponding prior year period. The decrease was primarily due to a reduction in personnel and stock-based compensation expenses. For the year ended December 31, 2024, G&A expenses were $22.2 compared to $32.4 million for the year ended December 31, 2023, primarily due to lower compensation-related costs.

Licensing expenses were $8.6 million for the quarter ended December 31, 2024 compared to $5.7 million for the prior year period. The increase was primarily attributable to a milestone achieved during the fourth quarter of 2024, the entirety of which was payable to a third party. For the year ended December 31, 2024, licensing expenses were $12.7 million compared to $14.7 million for the year ended December 31, 2023.

Revaluation of contingent consideration resulted in a $1.3 million gain for the quarter ended December 31, 2024 compared to a $26.3 million gain for the prior year period. For the year ended December 31, 2024, revaluation of contingent consideration resulted in a charge of $2.5 million compared to a $26.9 million gain for the year ended December 31, 2023.

During the quarter and year ended December 31, 2024, the Company recorded $86.9 million of in-process research and development expenses, representing the fair value of consideration expensed in connection with the in-license of bosakitug (ATI-045) and ATI-052, as well as transaction costs incurred. During the quarter ended December 31, 2023, the Company recorded an intangible asset impairment charge of $6.6 million representing the full balance of its in-process research and development intangible asset.