On August 14, 2025 MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on developing innovative antibody-based therapeutics for the treatment of cancer, reported financial results for the second quarter ended June 30, 2025, and highlighted recent corporate progress (Press release, MacroGenics, AUG 14, 2025, View Source [SID1234655309]).

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"Over the past several years, MacroGenics has established itself as a pioneer in the field of antibody-based therapeutics for patients battling cancer. Today, we have a promising portfolio spanning antibody drug conjugates and multi-specifics that we believe has the potential to generate significant value for both patients and shareholders alike," said Eric Risser, President and CEO of MacroGenics. "As we look ahead to the remainder of 2025 and beyond, we intend to drive MacroGenics to become an even more focused and capital-efficient biotechnology company as we advance our pipeline. In the coming quarters, we look forward to providing updates on our key strategic priorities related to pipeline and Company progress."

Key Strategic Priorities for 2025 and 2026

Determine development path for lorigerlimab based on data from the ongoing LORIKEET and LINNET studies.
Advance MGC026 and MGC028 programs to assess clinical proof-of-concept.
Submit Investigational New Drug (IND) application for MGC030.
Initiate IND-enabling studies for two new product candidates.
Forge partnerships and collaborations to accelerate development of the Company’s proprietary product candidates and technology platforms.
Improve MacroGenics’ financial position through a combination of enhanced operational efficiency, collaboration revenue, and monetization of assets.

Corporate Updates

Eric Risser named President, Chief Executive Officer and Director. Mr. Risser previously served as Chief Operating Officer at MacroGenics, overseeing several key company functions and has led the Company’s corporate development efforts, which have generated over $550 million in non-dilutive capital over the past three years. Mr. Risser succeeds Scott Koenig, M.D., Ph.D. who has stepped down after serving as President and Chief Executive Officer for the past 24 years.

Wholly Owned Programs

Lorigerlimab is a bispecific, tetravalent PD-1 × CTLA-4 DART molecule designed to enhance CTLA-4 blockade on dual-expressing, tumor-infiltrating lymphocytes compared to a PD-1/CTLA-4 monoclonal antibody (mAb) combination therapy, while maintaining maximal PD-1 blockade on all PD-1-expressing cells.

The ongoing Phase 2 LORIKEET study is a 150-patient randomized study evaluating lorigerlimab in combination with docetaxel vs. docetaxel alone in second-line, chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (mCRPC). The study was fully enrolled in late 2024 and the Company expects to provide a clinical update in the second half of 2025.
The ongoing Phase 2 LINNET study is a 60-patient monotherapy study evaluating lorigerlimab in patients with either platinum-resistant ovarian cancer or clear cell gynecologic cancer.

Emerging ADC Pipeline. MacroGenics is developing three antibody-drug conjugates (ADCs) that each incorporate a novel, glycan-linked topoisomerase I inhibitor (TOP1i)-based payload developed by the Company’s collaboration partner, Synaffix (a Lonza company).

MGC026 targets B7-H3, an antigen with broad expression across multiple solid tumors and a member of the B7 family of molecules involved in immune regulation. MGC026 is currently being evaluated in a Phase 1 dose escalation study in patients with advanced solid tumors, with dose expansion in selected indications expected to initiate in the second half of 2025.
MGC028 targets ADAM9, a member of the ADAM family of multifunctional type 1 transmembrane proteins that play a role in tumorigenesis and cancer progression and is overexpressed in multiple cancers. MGC028 is currently being evaluated in a Phase 1 dose escalation study in patients with advanced solid tumors.
MGC030 is a preclinical ADC that targets an undisclosed antigen expressed across several solid tumors. An IND application to the U.S. Food and Drug Administration (FDA) for MGC030 is planned for 2026.

Partnered Programs

MGD024 is a next-generation CD123 × CD3 DART molecule. Under an October 2022 exclusive option and collaboration agreement with Gilead Sciences, Inc. (Gilead), MacroGenics continues to enroll patients in a Phase 1 dose escalation study of MGD024 in patients with CD123-positive neoplasms, including acute myeloid leukemia and myelodysplastic syndromes. MacroGenics remains eligible to receive up to $1.7 billion in target nomination, option exercise and milestone payments related to MGD024 and two additional research programs under this agreement.
ZYNYZ (retifanlimab-dlwr) is a monoclonal antibody targeting PD-1 that the Company licensed to Incyte Corporation (Incyte) in 2017. In June 2025, MacroGenics and Sagard Healthcare Partners entered into a royalty purchase agreement in exchange for capped royalty interest on future global net sales of ZYNYZ. MacroGenics retains its other economic interests related to ZYNYZ including future potential development, regulatory and commercial milestones. MacroGenics will also continue to support a portion of global commercial manufacturing needs for ZYNYZ. MacroGenics remains eligible to receive up to $540.0 million in additional development, regulatory and commercial milestones.
TZIELD (teplizumab-mzwv) is a monoclonal antibody targeting CD3 that the Company sold in 2018 to a partner that was subsequently acquired by Sanofi S.A. (Sanofi). In November 2022, TZIELD was approved by U.S. FDA to delay the onset of Stage 3 type 1 diabetes (T1D) in adult and pediatric patients aged 8 years and older with Stage 2 T1D. In July 2025, Sanofi disclosed that they anticipate TZIELD-related regulatory decisions in the E.U. and China in the second half of 2025. MacroGenics remains eligible to receive up to $379.5 million in additional development, regulatory and commercial milestones.

Second Quarter 2025 Financial Results

Cash Position: Cash, cash equivalents and marketable securities balance as of June 30, 2025, was $176.5 million, compared to $201.7 million as of December 31, 2024.
Revenue: Total revenue was $22.2 million for the quarter ended June 30, 2025, compared to $10.8 million for the quarter ended June 30, 2024. Total revenue included contract manufacturing revenue of $15.4 million for the quarter ended June 30, 2025, compared to $2.9 million for the quarter ended June 30, 2024, reflecting higher manufacturing volume on behalf of Contract Development and Manufacturing Organization (CDMO) clients. Collaboration revenue was $6.9 million for the quarter ended June 30, 2025, compared to $2.2 million for the quarter ended June 30, 2024, with this increase primarily due to deferred revenue recognition under the Company’s collaboration agreements. Total revenue reflected a decrease in net product sales resulting from the sale of MARGENZA to TerSera Therapeutics, LLC in November 2024.
R&D Expenses: Research and development expenses were $40.8 million for the quarter ended June 30, 2025, compared to $51.7 million for the quarter ended June 30, 2024. The decrease was primarily due to decreased costs related to vobramitamab duocarmazine development and decreased manufacturing and IND-enabling costs related to MGC028, offset by increased costs related to MGC030 development.
Cost of Manufacturing Services: Cost of manufacturing services was $8.9 million for the quarter ended June 30, 2025, compared to $2.6 million for the quarter ended June 30, 2024. The increase was primarily due to an increase in manufacturing volume on behalf of CDMO clients.
SG&A Expenses: Selling, general and administrative expenses were $9.3 million for the quarter ended June 30, 2025, compared to $14.4 million for the quarter ended June 30, 2024. The decrease was primarily due to lower stock-based compensation expense and reduced professional fees. The reduction in professional fees was largely driven by the cessation of commercialization activities for MARGENZA.
Net Loss: Net loss was $36.3 million for the quarter ended June 30, 2025, compared to net loss of $55.7 million for the quarter ended June 30, 2024.
Shares Outstanding: Shares of common stock outstanding as of June 30, 2025 were 63,205,703.
Cash Runway Guidance: MacroGenics anticipates that its cash, cash equivalents and marketable securities balance of $176.5 million as of June 30, 2025, in addition to projected and anticipated future payments from partners and anticipated savings from the Company’s ongoing cost-reduction initiatives, is expected to support its cash runway through the first half of 2027.

MACROGENICS, INC.
SELECTED CONSOLIDATED BALANCE SHEET DATA
(Amounts in thousands)

June 30, 2025 December 31, 2024
(unaudited)
Cash, cash equivalents and marketable securities $ 176,486 $ 201,667
Total assets 245,416 261,655
Deferred revenue 63,617 71,822
Total stockholders’ equity 46,618 116,057

MACROGENICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
(Amounts in thousands, except share and per share data)

Three Months Ended June 30, Six Months Ended June 30,
2025 2024 2025 2024
Revenues:
Collaborative and other agreements $ 6,869 $ 2,163 $ 13,911 $ 3,772
Product sales, net — 5,248 — 10,109
Contract manufacturing 15,372 2,893 21,523 5,169
Government agreements — 493 — 851
Total revenues 22,241 10,797 35,434 19,901
Costs and expenses:
Cost of product sales — 176 — 446
Cost of manufacturing services 8,906 2,647 14,306 4,493
Research and development 40,791 51,732 80,489 97,760
Selling, general and administrative 9,302 14,423 20,020 29,133
Total costs and expenses 58,999 68,978 114,815 131,832
Loss from operations (36,758 ) (58,181 ) (79,381 ) (111,931 )
Interest and other income 1,414 2,523 3,093 5,216
Interest and other expense (802 ) (6 ) (894 ) (1,139 )
Loss before income taxes (36,146 ) (55,664 ) (77,182 ) (107,854 )
Income tax provision 105 — 105 —
Net loss (36,251 ) (55,664 ) (77,287 ) (107,854 )
Other comprehensive loss:
Unrealized (loss) gain on investments (6 ) 11 (12 ) (18 )
Comprehensive loss $ (36,257 ) $ (55,653 ) $ (77,299 ) $ (107,872 )

Basic and diluted net loss per common share $ (0.57 ) $ (0.89 ) $ (1.23 ) $ (1.73 )
Basic and diluted weighted average common shares outstanding 63,136,057 62,663,677 63,051,207 62,477,108

On August 14, 2025 Tvardi Therapeutics, Inc. ("Tvardi") (NASDAQ: TVRD), a clinical-stage biopharmaceutical company focused on the development of novel, oral, small molecule therapies targeting STAT3 to treat fibrosis-driven diseases, reported its financial and operating results for the second quarter ended June 30, 2025, and provided a business update (Press release, Tvardi Therapeutics, AUG 14, 2025, View Source [SID1234655324]).

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Second Quarter 2025 Highlights:

Announced completion of enrollment in its REVERT IPF clinical trial, a Phase 2 trial of TTI-101, for patients with idiopathic pulmonary fibrosis (IPF); topline data on track for Q4 2025.
Submitted an Investigational New Drug (IND) application for its second clinical candidate, TTI-109, with the U.S. Food and Drug Administration (FDA) in June 2025.
Announced that an abstract, entitled Single Cell Transcriptomics in A Treatment Status Segregated Cohort Exposes a STAT-3-Regulated Therapeutic Gap in Idiopathic Pulmonary Fibrosis, was presented at the American Thoracic Society (ATS) 2025 Annual Conference.
Completed its merger with Cara Therapeutics, transitioning Tvardi into a publicly traded company.
Imran Alibhai, Ph.D., Chief Executive Officer of Tvardi, stated, "We are on track for topline data in the fourth quarter from our fully enrolled REVERT IPF Phase 2 clinical trial. These data will offer important additional insights into the safety and efficacy of TTI-101, and, if positive, we believe will further validate our approach of targeting STAT3, a central mediator of fibrosis, to treat patients with IPF.

"In parallel, our Phase 2 REVERT Liver Cancer trial continues to enroll patients, and we remain on track to report topline results in the first half of 2026. Prior interim data from this ongoing study demonstrated clinically meaningful activity of TTI-101 as both monotherapy and in combination with established anti-cancer agents across treatment lines.

"Importantly, we are well-financed through these potential value inflection points, and into Q4 of next year. We believe we are very well positioned to bring meaningful innovation to patients living with fibrosis driven-diseases while creating significant value for our company."

Upcoming Milestones:

Data from the company’s ongoing REVERT IPF Phase 2 clinical trial of TTI-101 anticipated in 4Q 2025
Preliminary topline data from the company’s ongoing REVERT Liver Cancer Phase 1b/2 clinical trial of TTI-101 anticipated in 1H 2026
Second Quarter 2025 Financial Results

Research and development expenses for the three months ended June 30, 2025, were $5.8 million as compared to $6.5 million for the comparable period in 2024. The decrease of $0.7 million was primarily driven by clinical, pre-clinical, and CMC costs associated with TTI-101.

General and administrative expenses for the three months ended June 30, 2025, were $3.1 million as compared to $650,000 for the comparable period in 2024. The increase of $2.4 million was primarily driven by increases in professional fees of $1.6 million, attributable to increased legal, accounting and audit fees incurred as a result of the merger. The remaining increase was attributable to increases in personnel costs, insurance costs, and other costs.

Net income for the three months ended June 30, 2025, was $4.2 million as compared to a net loss of $7.0 million for the comparable period in 2024. The improvement in net income was due primarily to a $12.8 million remeasurement gain on Tvardi’s Convertible Notes recognized in the second quarter of 2025.

Basic and diluted net income (loss) per share attributable to common shareholders for the three months ended June 30, 2025, were a net gain of $0.51 and net loss of $1.00, respectively, compared to a net loss of $2.71 on a basic and diluted basis for the comparable period in 2024.

Cash, cash equivalents and short-term investments as of June 30, 2025, were $41.0 million, as compared to $31.6 million as of December 31, 2024.

On August 14, 2025 Abeona Therapeutics Inc. (Nasdaq: ABEO) reported financial results and business highlights for the second quarter of 2025 and shared recent operational progress (Press release, Abeona Therapeutics, AUG 14, 2025, View Source [SID1234655279]).

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"ZEVASKYN’s launch is demonstrating positive early momentum," said Vish Seshadri, Chief Executive Officer of Abeona. "The first ZEVASKYN patient treatment is on track for the third quarter of 2025 with multiple additional patients identified and advancing through the process to initiate treatment. The enthusiasm from the RDEB community and clinicians, alongside our substantial progress with payer coverage, affirms ZEVASKYN’s crucial role in transforming patient care."

Recent Developments

FDA approval and commercial launch of ZEVASKYN

● FDA approval of first-in-class RDEB therapy: In April 2025, the U.S. FDA approved ZEVASKYN (prademagene zamikeracel) for the treatment of wounds in adult and pediatric patients with RDEB.
● ZEVASKYN now available at Qualified Treatment Centers (QTCs): RDEB patients can access ZEVASKYN at both Ann & Robert H. Lurie Children’s Hospital of Chicago and Lucile Packard Children’s Hospital Stanford. The Company is on track and expects to activate additional sites in 2025.
● Strong demand for ZEVASKYN with several patients identified and treatment process initiated: The first ZEVASKYN patient has been biopsied and treatment is expected in 3Q 2025. Demand for ZEVASKYN continues to grow with more than a dozen patients identified within the two QTCs and several advancing through the administrative process. In addition, more than three dozen patients have already been identified as candidates for ZEVASKYN at referring sites (non-QTCs).
● Secured broad patient access: So far, 100% of submitted prior authorization requests have been approved. Among commercial insurers that cover approximately 60% of RDEB lives, positive coverage for ZEVASKYN has been established with multiple large national and regional payers. United Healthcare, the nation’s largest payer covering more than 43 million lives or approximately 16% of the U.S. insured population, published a favorable coverage policy for ZEVASKYN consistent with the FDA-approved label without imposing any additional restrictions. Abeona has entered into the National Drug Rebate Agreement (NDRA) with the U.S. Centers for Medicare and Medicaid Services (CMS) to facilitate expedited coverage and reimbursement for ZEVASKYN across all 51 state Medicaid programs and Puerto Rico. Some states have already implemented favorable coverage criteria for ZEVASKYN.

● Ramping up supply of ZEVASKYN: Abeona remains on-track to scale-up supply capacity for up to 10 patients per month in mid-2026.
● Broadening ZEVASKYN medical awareness: In June, The Lancet, a respected global medical journal, published results from the pivotal Phase 3 VIITAL study (NCT04227106) evaluating the efficacy and safety of ZEVASKYN for the treatment of RDEB wounds.

Other corporate updates

● Licensing agreement for novel AAV204 capsid for ophthalmology gene therapy: Beacon Therapeutics exercised its option to license from Abeona the AAV204 capsid for use in potential gene therapies for a range of prevalent and rare retinal diseases.
● Secured non-dilutive capital: Abeona closed the sale of its Rare Pediatric Disease priority review voucher (PRV) for gross proceeds of $155 million. Abeona was awarded the PRV upon FDA approval of ZEVASKYN.

Financial Results

Cash, cash equivalents, restricted cash and short-term investments totaled $225.9 million as of June 30, 2025, including net proceeds from the PRV sale. The current cash position, without accounting for anticipated revenue from ZEVASKYN, is expected to be sufficient to fund current and planned operations for over two years.

As Abeona transitions into a commercial organization, its second quarter financial results show the reclassification of certain manufacturing and development costs from research and development (R&D) expense to inventory or selling, general, and administrative (SG&A) expenses.

R&D spending for the three months ended June 30, 2025 was $5.9 million, compared to $9.2 million for the same period of 2024. The reduction in R&D expense was primarily due to costs capitalized into inventory and select costs, such as engineering runs and other production costs, reclassified as SG&A following FDA approval of ZEVASKYN. SG&A expenses were $17.1 million for the three months ended June 30, 2025, compared to $8.6 million for the same period of 2024. In addition to the reclassification of select R&D expense to SG&A, the increase in SG&A reflects increased headcount and professional costs associated with the commercial launch of ZEVASKYN.

Net income was $108.8 million for the second quarter of 2025, or $2.07 per basic and $1.71 per diluted common share, including the gain from the sale of the PRV. Net income in the second quarter of 2024 was $7.4 million, or $0.19 per basic and a net loss of $(0.26) per diluted common share.

Conference Call Details

The Company will host a conference call and webcast on Thursday, August 14, 2025, at 8:30 a.m. ET, to discuss the financial results and corporate progress. To access the call, dial 877-545-0320 (U.S. toll-free) or 973-528-0002 (international) and Entry Code: 829076 five minutes prior to the start of the call. A live, listen-only webcast and archived replay of the call can be accessed on the Investors & Media section of Abeona’s website at View Source The archived webcast replay will be available for 30 days following the call.

On August 14, 2025 NanoCell Therapeutics, Inc. ("NanoCell"), a biotechnology company developing a non-viral, DNA-based in vivo gene therapy platform, reported it has been awarded a Eurostars Grant from the European Union (EU) through the Horizon Europe program and the Eureka Network (Press release, NanoCell Therapeutics, AUG 14, 2025, View Source [SID1234655310]). The grant will fund NanoCell’s QUIET-CAR project, which is focused on the development of targeted lipid nanoparticles containing novel immune-quiet DNA constructs for in vivo CAR-T therapy.

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"This funding validates our innovative approach to non-viral gene therapy and will accelerate our QUIET-CAR project toward delivering safer, more accessible CAR-T treatments for patients with cancer and autoimmune disease," said Dr. Maurits Geerlings, CEO and President of NanoCell Therapeutics. "Being selected and top ranked among over 120 submissions in Europe’s most competitive SME funding program demonstrates the transformative potential of our technology platform."

The QUIET-CAR project is a collaboration between NanoCell and CPTx, a biotech company developing advanced medicine using AI-supported molecular design and programmable single-stranded DNA fabrication supported by gxstrands. Eurostars, part of the European Partnership on Innovative SMEs and supported by Horizon Europe, is a premier funding initiative designed to accelerate transnational innovation. With participation from 37 countries, the program rigorously selects only the most promising technological breakthroughs, evaluated by independent experts.

NanoCell acknowledges the support of Amsterdam-based Catalyze for the successful preparation of this grant.

On August 14, 2025 Daiichi Sankyo (TSE: 4568) reported it will present new clinical research across its DXd antibody drug conjugate (ADC) portfolio in lung cancer at the IASLC 2025 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer (#WCLC25) (Press release, Daiichi Sankyo, AUG 14, 2025, https://www.businesswire.com/news/home/20250814589664/en/Daiichi-Sankyo-Presents-New-Data-in-Small-Cell-Lung-Cancer-and-Updates-Across-ADC-Portfolio-Highlighting-Progress-in-Creating-New-Standards-of-Care-for-Patients-with-Lung-Cancer-at-WCLC [SID1234655325]).

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Data at WCLC will showcase the company’s progress towards creating new standards of care for patients with lung cancer, including a late-breaking oral presentation featuring the primary analysis from the dose optimization and dose expansion parts of the IDeate-Lung01 phase 2 trial (OA06.03) of ifinatamab deruxtecan (I-DXd) in patients with pretreated extensive-stage small cell lung cancer (ES-SCLC). Interim data from the dose optimization part of the trial was previously presented at 2024 WCLC.

"The late-breaking data at WCLC continues to demonstrate the potential of ifinatamab deruxtecan to become a first-in-class B7-H3 directed antibody drug conjugate for patients with pretreated extensive-stage small cell lung cancer, where treatment options following platinum-based chemotherapies are limited," said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. "These data along with other important updates across our portfolio continue to demonstrate how our DXd antibody drug conjugate technology is being leveraged to create new medicines for patients with cancer."

Additional data updates at WCLC include an oral presentation featuring a retrospective analysis of the intracranial efficacy of DATROWAY (datopotamab deruxtecan) or docetaxel in patients with non-small cell lung cancer (NSCLC) and baseline brain metastases in the TROPION-Lung01 phase 3 trial (0A10.01), and a poster presentation of the final results of the DESTINY-Lung05 phase 2 trial (P2.10.12) of ENHERTU (trastuzumab deruxtecan) in patients from China with previously treated HER2 mutant NSCLC.

Trials-in-Progress Across DXd ADC Portfolio

Several trials-in-progress poster presentations at WCLC further highlight the Daiichi Sankyo R&D strategy of continuing to expand the DXd ADC portfolio to address a broad spectrum of unmet needs for patients with lung cancer, including the DESTINY-Lung06 phase 3 trial evaluating the efficacy and safety of ENHERTU plus pembrolizumab versus platinum-based chemotherapy plus pembrolizumab as a first-line treatment strategy for patients with HER2 overexpressing, PD-L1 TPS <50% metastatic NSCLC.

Other early phase trials evaluating additional treatment strategies in lung cancer include the KEYMAKER-U01 substudy 01G phase 2 trial evaluating patritumab deruxtecan (HER3-DXd) in combination with pembrolizumab with or without platinum chemotherapy in patients with previously untreated stage 4 NSCLC, and a phase 1b/2 trial evaluating ifinatamab deruxtecan and gocatamig, a DLL3 targeted T-cell engager, in patients with relapsed or refractory ES-SCLC will be highlighted.

Investor Briefing Following WCLC

Daiichi Sankyo will hold a virtual conference call for investors on Wednesday, September 17, 2025 from 7:00 to 8:15 pm EDT / Thursday, September 18 from 8:00 to 9:15 am JST. Executives from Daiichi Sankyo will provide an overview of the late-breaking WCLC data and clinical development plan for ifinatamab deruxtecan.

WCLC Presentation Overview

Presentation Title

Presenter

Abstract

Presentation (CEST)

Ifinatamab Deruxtecan (I-DXd)

Ifinatamab deruxtecan (I-DXd) in extensive-stage small cell lung cancer: primary analysis of the phase 2 IDeate-Lung01 study

M. Ahn

OA06.03

Oral Presentation

Sunday, September 7

4:45– 6:00 pm

A phase 1b/2 study of gocatamig and ifinatamab deruxtecan for relapsed or refractory extensive-stage small cell lung cancer

P. Rocha

P3.18.73

Poster Presentation

Tuesday, September 9

10:00 – 11:30 am

ENHERTU (trastuzumab deruxtecan; T-DXd)

Trastuzumab deruxtecan in patients from China with pretreated HER2 mutant NSCLC: final results from the DESTINY-Lung05 study

B. Wang

P2.10.12

Poster Session

Monday, September 8

10:30 am – 12:00 pm

Trastuzumab deruxtecan + pembrolizumab as first-line treatment in HER2 overexpressing, PD-L1 TPS <50% NSCLC (DESTINY-Lung06)

W.N. William

P3.18.58

Poster Session

Tuesday, September 9

10:00 – 11:30 am

Concordance of HER2 protein overexpression by IHC and ERBB2 gene amplification by NGS in lung cancer

S. Yeramaneni

P1.17.22

Poster Session

Sunday, September 7

10:30 am – 12:00 pm

DATROWAY (datopotamab deruxtecan; Dato-DXd)

Intracranial efficacy of datopotamab deruxtecan (Dato- DXd) in patients with advanced/metastatic NSCLC in TROPION-Lung01

E. Pons-Tostivint

OA10.01

Oral Presentation

Monday, September 8

3:30 – 4:45 pm

Real world assessment of TROP2-NMR by quantitative continuous scoring (QCS) in non-small cell lung carcinoma (NSCLC)

F. Lopez-Rios

OA09.03

Oral Presentation

Monday, September 8

3:30 – 4:45 pm

Patritumab Deruxtecan (HER3-DXd)

KEYMAKER-U01 substudy 01G: pembrolizumab + patritumab deruxtecan ± chemotherapy in previously untreated stage IV NSCLC

V. Velcheti

P3.18.28

Poster Presentation

Tuesday, September 9

10:00 – 11:30 am

About the ADC Portfolio of Daiichi Sankyo

The Daiichi Sankyo ADC portfolio consists of seven ADCs in clinical development crafted from two distinct ADC technology platforms discovered in-house by Daiichi Sankyo.

The ADC platform furthest in clinical development is Daiichi Sankyo’s DXd ADC Technology where each ADC consists of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADC portfolio currently consists of ENHERTU, a HER2 directed ADC, and DATROWAY, a TROP2 directed ADC, which are being jointly developed and commercialized globally with AstraZeneca. Patritumab deruxtecan (HER3-DXd), a HER3 directed ADC, ifinatamab deruxtecan (I-DXd), a B7-H3 directed ADC, and raludotatug deruxtecan (R-DXd), a CDH6 directed ADC, are being jointly developed and commercialized globally with Merck & Co., Inc, Rahway, NJ, USA. DS-3939, a TA-MUC1 directed ADC, is being developed by Daiichi Sankyo.

The second Daiichi Sankyo ADC platform consists of a monoclonal antibody attached to a modified pyrrolobenzodiazepine (PBD) payload. DS-9606, a CLDN6 directed PBD ADC, is the first of several planned ADCs in clinical development utilizing this platform. Ifinatamab deruxtecan, patritumab deruxtecan, raludotatug deruxtecan, DS-3939 and DS-9606 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established.