Mabwell to Present Clinical Data of 9MW2821 Combined with Toripalimab in Patients with UC in an Oral Presentation at 2025 ASCO

On April 24, 2025 Mabwell (688062.SH), an innovation-driven biopharmaceutical company with an entire industry chain, reported that the Phase Ib/II clinical study results of the novel Nectin-4-targeting ADC 9MW2821 combined with toripalimab in patients with locally advanced or metastatic urothelial carcinoma will be presented in an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in Chicago, USA, May 30-June 3, 2025 (Press release, Mabwell Biotech, APR 24, 2025, View Source [SID1234652114]). Clinical data from 3 ADC clinical studies will also be published as poster presentations at the meeting.

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Oral Presentation

1. Title: 9MW2821, a novel Nectin-4 antibody-drug conjugate (ADC), combined with toripalimab in treatment-naive patients with locally advanced or metastatic urothelial carcinoma (la/mUC): Results from a phase 1b/2 study.
Abstract Number for Publication: 4519
Presenter: Prof. Sheng Xinan, Chief Physician, Dept. of Urologic Oncology (Beijing Cancer Hospital)
Session Type and Title: Rapid Oral Abstract-Genitourinary Cancer-Kidney and Bladder
Session Date and Time: 5/31/2025, 1:15 PM-2:45 PM CDT

Poster Presentation

1. Title: Results from a phase 1/2 study of 7MW3711: A novel B7-H3 antibody-drug conjugate (ADC) incorporating a topoisomerase I inhibitor in patients with advanced solid tumors.
Abstract Number: 3035
Session Type and Title: Poster Session – Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
Poster Board: 350
Session Date and Time: 6/2/2025 1:30 PM-4:30 PM CDT

2. Title: Results from a phase 1/2 study of 7MW3711: A novel B7-H3 antibody-drug conjugate (ADC) incorporating a topoisomerase I inhibitor in patients with lung cancer.
Abstract Number: 3036
Session Type and Title: Poster Session – Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
Poster Board: 351
Session Date and Time: 6/2/2025 1:30 PM-4:30 PM CDT

3. Title: A first-in-human clinical study of 9MW2921, a novel TROP-2 antibody-drug conjugate (ADC), in patients with advanced solid tumors.
Abstract Number: 3029
Session Type and Title: Poster Session – Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
Poster Board: 344
Session Date and Time: 6/2/2025 1:30 PM-4:30 PM CDT

BioNTech to Present Clinical and Preclinical Data Across mRNA and Next-Generation Immuno-Oncology Priority Programs at AACR 2025

On April 24, 2025 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported it will present data for selected assets from its diversified oncology pipeline, including mRNA cancer immunotherapies, next-generation immunomodulators, and targeted therapies, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) ("AACR") Annual Meeting held in Chicago, Illinois from April 25-30, 2025 (Press release, BioNTech, APR 24, 2025, View Source [SID1234652098]). The oral and poster presentations underline both the progress of BioNTech’s advanced priority oncology programs as well as the execution of the Company’s combination strategy in oncology, with first data to be presented for the combination of the PD-L1xVEGF-A bispecific antibody candidate BNT3271 plus antibody-drug conjugates ("ADCs").

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"We believe that the future standard of care for the treatment of advanced cancers will be combinations with novel immuno-oncology backbones," said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. "Our data presentations at this year’s AACR (Free AACR Whitepaper) support our approach to combine complementary mechanisms of action with the aim of driving synergistic anti-tumor activity. The data we present indicate that we are well positioned to work towards our vision of improving outcomes for patients across the full continuum of cancer disease."

Highlights of BioNTech’s oncology programs to be presented at AACR (Free AACR Whitepaper) 2025:

BioNTech will present preclinical data characterizing the mode of action of BNT327. BNT327 is an investigational next-generation bispecific antibody combining PD-L1 checkpoint inhibition with VEGF-A neutralization. BNT327 showed a high binding affinity to PD-L1 and VEGF-A and efficient blocking of PD-1/PD-L1 and VEGF-A/VEGFR2 signaling. Anti-tumor activity superior to single PD-1/PD-L1 blockade or anti-VEGF-A treatment was observed in multiple tumor models.

First data for the combination of BNT327 with various ADC candidates, which are being jointly developed by BioNTech and Duality Biologics (Suzhou) Co. Ltd. ("DualityBio"), will be presented. The presentation will include preclinical evaluation of BNT327 plus ADCs, showing inhibition of tumor growth that is superior to each candidate alone. Further, early clinical data of the ongoing global Phase 1/2 trial (NCT05438329) of BNT327 in combination with BNT325/DB-1305, a TROP2-targeting ADC candidate, including safety and early efficacy data, will be presented in the poster session.

BioNTech will present data from the Phase 1 clinical trial LuCa-MERIT-1 (NCT05142189) for its mRNA cancer immunotherapy candidate BNT116 in combination with the anti-PD1 cemiplimab in an oral presentation. The update includes safety and clinical activity data, along with biomarker data from a cohort of frail patients with advanced or metastatic non-small cell lung cancer ("NSCLC") who were not eligible for platinum-based chemotherapy as first-line treatment. The preliminary data showed anti-tumor activity, consistent immune response induction, and a manageable safety profile.

Preclinical data for the EpCAMx4-1BB antibody candidate BNT314/GEN1059, which is being developed in collaboration with Genmab A/S ("Genmab"), will be presented in a poster session. BNT314/GEN1059 was evaluated in combination with PD-1 inhibition in a tumor model unresponsive to each single treatment. The data showed anti-tumor activity, delayed tumor outgrowth and prolonged survival for the combination treatment compared to both single treatments. The immunomodulatory activity of BNT314/GEN1059 was further potentiated in combination with PD-1 blockade.

BioNTech has established a diversified oncology portfolio including mRNA cancer immunotherapies, next-generation immunomodulators, and targeted therapies, comprising ADCs and cell therapies, to develop novel treatment approaches for patients living with cancer. The Company is further maturing its clinical oncology pipeline across multiple solid tumor indications, including more than 20 active Phase 2 and Phase 3 clinical trials with a strategic focus on two pan-tumor priority programs: investigational mRNA cancer immunotherapies and the next-generation immunomodulator candidate BNT327. BioNTech expects multiple data readouts in 2025 and 2026 aimed at supporting its strategy and advancing the Company towards becoming a diversified multi-product oncology company.

The full abstracts are available on the AACR (Free AACR Whitepaper) Annual Meeting website. Click here for further information on BioNTech’s pipeline assets.

Full presentation details:

Oral presentation

Asset: BNT116
Session Title: "ADCs and Immunooncology-focused Biological Approaches"
Abstract Title: "Phase I trial evaluating BNT116, a TAA-encoding mRNA vaccine, in combination with cemiplimab in frail patients with advanced non-small cell lung cancer (NSCLC)"
Abstract Number: CT013
Location: Room S100 A (Grand Ballroom A)
Date: Sunday, April 27, 2025
Time: 4:20 PM – 4:30 PM CDT

Poster presentations

Asset: BNT327 + BNT325/DB-1305
Session Title: "Combination Immunotherapies"
Abstract Title: "Activity of BNT327/PM8002 (PD-L1 x VEGF-A bispecific antibody) in combination with BNT325/DB-1305 (TROP2 ADC) in solid tumors: Early preclinical and clinical evidence to support BNT327 + ADC combinations"
Poster Number: 648 / 14
Location: Section 28
Date: Sunday, April 27, 2025
Time: 2:00 PM – 5:00 PM CDT

Asset: BNT327
Session Title: "Antibodies 3: Multi-Target Checkpoint Inhibitors and Immune Activators"
Abstract Title: "Dual PD-L1 blockade and VEGF-A neutralization with the bispecific antibody BNT327/PM8002 shows potent antitumor activity in preclinical models"
Poster Number: 6061 / 2
Location: Section 37
Date: Tuesday, April 29, 2025
Time: 2:00 PM – 5:00 PM CDT

Asset: BNT314/ GEN1059
Session Title: "Antibodies 3: Multi-Target Checkpoint Inhibitors and Immune Activators"
Abstract Title: "The combination of an EpCAMx4-1BB bispecific antibody with PD-1 blockade exhibits antitumor activity in a murine tumor model unresponsive to each individual antibody"
Poster Number: 6075 / 16
Location: Section 37
Date: Tuesday, April 29, 2025
Time: 2:00 PM – 5:00 PM CDT

Verismo Therapeutics Announces Poster Presentation at ASCO 2025

On April 24, 2025 Verismo Therapeutics, a clinical-stage CAR T company pioneering the KIR-CAR platform, reported a Trials in Progress poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), being held from May 30 – June 3, 2025 in Chicago, IL (Press release, Verismo Therapeutics, APR 24, 2025, View Source [SID1234652115]). Poster details are below.

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Poster Details:
Abstract Number: TPS5630
Abstract Title: SynKIR-CAR T Cell Advanced Research (STAR)-101 phase 1 clinical trial for patients with advanced mesothelin-expressing ovarian cancer, mesothelioma, or cholangiocarcinoma.
Presenting Author: Janos L. Tanyi, M.D., Ph.D., Perelman School of Medicine at the University of Pennsylvania
Session Title: Gynecologic Cancer
Session Date: June 1, 2025, 9:00 AM-12:00 PM CDT

About the KIR-CAR Platform

The KIR-CAR platform is a multi-chain CAR T cell therapy and has been shown in preclinical animal models to be capable of maintaining antitumor T cell activity even in challenging tumor microenvironments. Using NK cell derived KIR and DAP12 split signaling provides a novel combined activation and co-stimulation separate from the usual T cell stimulation pathways. It also enables sustained chimeric receptor expression and improves KIR-CAR T cell long term function. This results in prolonged T cell functional persistence and leads to tumor regression in preclinical models that are resistant to traditional CAR T cell therapies. As a result of decreased T cell exhaustion, KIR-CAR also enables targeting of solid tumors in addition to blood cancers.

Bristol Myers Squibb Reports First Quarter Financial Results for 2025

On April 24, 2025 Bristol Myers Squibb (NYSE: BMY) reported results for the first quarter of 2025 (Press release, Bristol-Myers Squibb, APR 24, 2025, View Source [SID1234652099]).

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"Our strong execution in the first quarter drove continued momentum across our Growth Portfolio and meaningful progress in the pipeline," said Christopher Boerner, Ph.D., board chair and chief executive officer, Bristol Myers Squibb. "We are advancing our multi-year plan to become a more agile and efficient company, while strengthening the foundation for top-tier, long-term growth. Our strategy is clear, and our actions are accelerating the delivery of transformational medicines to patients."

First Quarter Results

$ in millions, except per share amounts

2025

2024

Change

Change
Excl. FX**

Total Revenues

$11,201

$11,865

(6)%

(4)%

Earnings/(Loss) Per Share – GAAP*

1.20

(5.89

)

N/A

N/A

Earnings/(Loss) Per Share – Non-GAAP*

1.80

(4.40

)

N/A

N/A

Acquired IPRD Charge and Licensing Income Net Impact on Earnings/(Loss) Per Share

(0.04

)

(6.30

)

N/A

N/A

*GAAP and Non-GAAP earnings/(loss) per share include the net impact of Acquired IPRD charges and licensing income.

**See "Use of Non-GAAP Financial Information".

FIRST QUARTER RESULTS
All comparisons are made versus the same period in 2024 unless otherwise stated.

Total revenues of $11.2 billion decreased 6%, or 4% Ex-FX.
U.S. revenues of $7.9 billion decreased 7%.
International revenues of $3.3 billion decreased 2%, or increased 2% Ex-FX.
Growth Portfolio revenues of $5.6 billion increased 16% on a reported basis, or 18% Ex-FX. Revenue growth was primarily driven byOpdivo, Breyanzi, Reblozyl andCamzyos and reflects the strong early U.S. launch ofCobenfy.
Legacy Portfolio revenues of $5.6 billion declined 20% on a reported basis and Ex-FX. The decline was driven by continued generic impact on Revlimid, Pomalyst, Sprycel andAbraxane, as well as the impacts from U.S. Medicare Part D redesign.
FIRST QUARTER PRODUCT REVENUE HIGHLIGHTS(d)

($ amounts in millions)

Quarter Ended March 31,
2025

% Change from Quarter
Ended March 31, 2024

% Change from
Quarter Ended
March 31, 2024
Ex-FX**

U.S.

Int’l

WW(c)

U.S.

Int’l

WW(c)

Int’l

WW(c)

Growth Portfolio

Opdivo

$ 1,332

$ 933

$ 2,265

15%

1%

9%

7%

12%

Opdivo Qvantig

8

9

N/A

N/A

N/A

N/A

N/A

Orencia

555

215

770

(3)%

(5)%

(4)%

(1)%

(2)%

Yervoy

394

230

624

7%

7%

7%

12%

9%

Reblozyl

390

89

478

33%

44%

35%

49%

36%

Opdualag

228

25

252

15%

>200%

23%

>200%

23%

Breyanzi

204

60

263

133%

>200%

146%

>200%

148%

Camzyos

126

33

159

63%

>200%

89%

>200%

90%

Zeposia

61

46

107

(16)%

22%

(3)%

26%

(2)%

Abecma

59

45

103

13%

47%

26%

54%

28%

Sotyktu

32

23

55

(5)%

138%

27%

146%

29%

Krazati

44

4

48

116%

>200%

125%

>200%

125%

Cobenfy

27

27

N/A

N/A

N/A

N/A

N/A

Other Growth Products(a)

174

229

403

13%

34%

24%

35%

25%

Total Growth Portfolio

3,633

1,930

5,563

18%

13%

16%

18%

18%

Legacy Portfolio

Eliquis

2,646

919

3,565

(6)%

2%

(4)%

5%

(3)%

Revlimid

809

127

936

(44)%

(41)%

(44)%

(39)%

(44)%

Pomalyst/Imnovid

537

122

658

(10)%

(55)%

(24)%

(53)%

(24)%

Sprycel

126

49

175

(56)%

(47)%

(53)%

(43)%

(53)%

Abraxane

40

65

105

(72)%

(10)%

(52)%

(6)%

(50)%

Other Legacy Products(b)

82

116

199

(14)%

(10)%

(12)%

(8)%

(11)%

Total Legacy Portfolio

4,240

1,398

5,638

(21)%

(17)%

(20)%

(14)%

(20)%

Total Revenues

$ 7,873

$ 3,328

$ 11,201

(7)%

(2)%

(6)%

2%

(4)%

**

See "Use of Non-GAAP Financial Information".

(a)

Includes Augtyro, Onureg, Inrebic, Nulojix, Empliciti and royalty revenue.

(b)

Includes other mature brands.

(c)

Worldwide (WW) includes U.S. and International (Int’l).

(d)

For the above table and all subsequent tables, certain totals may not sum due to rounding. Percentages have been calculated using unrounded amounts.

FIRST QUARTER COST & EXPENSES
All comparisons are made versus the same period in 2024 unless otherwise stated.

The table below presents selected line item information.

Three Months Ended March 31,
2025

Three Months Ended March 31,
2024

($ amounts in millions)

GAAP

Specified
Items**

Non-
GAAP

GAAP

Specified
Items**

Non-
GAAP

Cost of products sold

$

3,033

(14

)

$

3,018

$

2,932

(22

)

$

2,910

Gross margin(a)

72.9

%

73.1

%

75.3

%

75.5

%

Selling, general and administrative

1,584

(1

)

1,583

2,367

(378

)

1,989

Research and development

2,257

(21

)

2,235

2,695

(349

)

2,346

Acquired IPRD

188

188

12,949

12,949

Amortization of acquired intangible assets

830

(830

)

2,357

(2,357

)

Other (income)/expense, net

339

(489

)

(150

)

81

(235

)

(154

)

Effective tax rate

17.1

%

(2.1

)%

15.1

%

(3.4

)%

(5.6

)%

(9.0

)%

**See "Use of Non-GAAP Financial Information" and refer to the Specified Items schedule below for further detail.

(a) Represents revenue minus cost of products sold divided by revenue.

Gross margin decreased from 75.3% to 72.9% on a GAAP basis, and from 75.5% to 73.1% on a non-GAAP basis, primarily due to product mix.
Selling, general and administrative expenses of $1.6 billion decreased 33% on a GAAP basis, primarily due to one-time acquisition-related expenses in 2024 and results from our strategic productivity initiative in 2025. Non-GAAP selling, general and administrative expenses of $1.6 billion decreased 20%, primarily reflecting results from our strategic productivity initiative.
Research and development expenses of $2.3 billion decreased 16% on a GAAP basis, primarily from one-time acquisition-related expenses in 2024. Non-GAAP research and development expenses of $2.2 billion decreased 5%, primarily driven by results from our strategic productivity initiative.
Acquired IPRD charge of $188 million decreased from $12.9 billion on a GAAP and non-GAAP basis, primarily due to the prior year Karuna acquisition and SystImmune collaboration. Licensing income of $87 million increased from $12 million.
Amortization of acquired intangible assets of $830 million decreased 65% on a GAAP basis, primarily due to lower amortization expense related toRevlimid.
Effective tax rate in 2025 on a GAAP and non-GAAP basis was 17.1% and 15.1%, respectively. The 2024 GAAP and non-GAAP effective tax rate was impacted by the $12.1 billion one-time non-tax-deductible charge for the Karuna acquisition.
Reported net income attributable to Bristol Myers Squibb on a GAAP basis of $2.5 billion, or $1.20 per share, in the first quarter compared to a net loss of $11.9 billion, or $(5.89) per share, in the prior year. Non-GAAP net earnings attributable to Bristol Myers Squibb of $3.7 billion, or $1.80 per share, compared to a net loss of $8.9 billion, or $(4.40) per share, in the prior year.
PRODUCT AND PIPELINE UPDATES
Entries organized by date and inclusive of first quarter and recent updates.

Asset

Date
Announced

Milestone

CobenfyTM
(xanomeline and
trospium
chloride)

April 22

The Phase 3 ARISE trial evaluating Cobenfy as an adjunctive treatment to atypical antipsychotics in adults with schizophrenia did not meet the threshold for statistical significance for the primary endpoint.

Camzyos
(mavacamten)

April 17

The U.S. Food and Drug Administration (FDA) updated the U.S. Prescribing Information for Camzyos, simplifying treatment options for patients and physicians by reducing the required echo monitoring for eligible patients in the maintenance phase and expanding patient eligibility by reducing contraindications.

Camzyos

April 14

The Phase 3 ODYSSEY-HCM trial evaluating Camzyos for the treatment of adult patients with symptomatic New York Heart Association class II-III non-obstructive hypertrophic cardiomyopathy did not meet its dual primary endpoints.

Opdivo
(nivolumab) +
Yervoy
(ipilimumab)

April 11

The FDA approved Opdivo plus Yervoy as a first-line treatment for adult patients with unresectable or metastatic hepatocellular carcinoma (HCC).

Opdivo + Yervoy

April 8

The FDA approved Opdivo plus Yervoy as a first-line treatment of adult and pediatric patients (12 years and older) with unresectable or metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer.

Opdivo

March 28

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended approval of the perioperative regimen of Opdivo, in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by Opdivo as monotherapy, as adjuvant treatment after surgical resection for the treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumors have PD-L1 expression ≥1%.

Subcutaneous
formulation of
Opdivo

March 28

The CHMP of the EMA recommended approval of a new Opdivo formulation associated with a new route of administration (subcutaneous use), a new pharmaceutical form (solution for injection) and a new strength (600 mg/vial).

Breyanzi
(lisocabtagene
maraleucel)

March 14

The European Commission (EC) granted approval to Breyanzi for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.

Sotyktu
(deucravacitinib)

March 8

Announced positive data from the pivotal Phase 3 POETYK PsA-2 trial evaluating the efficacy and safety of Sotyktu in adults with active psoriatic arthritis.

Opdivo + Yervoy

March 7

The EC approved Opdivo plus Yervoy for the first-line treatment of adult patients with unresectable or advanced HCC.

Opdivo

February 19

Announced the final analysis of overall survival (OS) from the Phase 3 CheckMate -816 study. The results showed a statistically significant and clinically meaningful improvement in OS, a key secondary endpoint, compared to neoadjuvant chemotherapy alone.

Sotyktu

February 16

Announced new five-year results from the POETYK PSO long-term extension trial of Sotyktu treatment in adult patients with moderate-to-severe plaque psoriasis. The safety profile of Sotyktu remained consistent through five years with no new safety signals identified.

OpdualagTM
(nivolumab and
relatlimab-rmbw)

February 13

The Phase 3 RELATIVITY-098 trial evaluating Opdualag for the adjuvant treatment of patients with completely resected stage III-IV melanoma did not meet its primary endpoint of recurrence-free survival.

Breyanzi

February 10

Announced positive topline results from the Phase 2 TRANSCEND FL trial evaluating Breyanzi in adult patients with relapsed or refractory marginal zone lymphoma. The trial cohort met its primary endpoint of overall response rate and key secondary endpoint of complete response rate.

Financial Guidance
Bristol Myers Squibb is raising key 2025 non-GAAP line-item guidance assumptions as outlined below.

The company is increasing its full-year revenue guidance from approximately $45.5 billion to a range of approximately $45.8 billion to $46.8 billion, reflecting the strong performance of the Growth Portfolio, better-than-expected Legacy Portfolio sales in the first quarter of 2025, and a favorable impact of approximately $500 million related to foreign exchange rates.

In addition, full-year operating expense expectations remain approximately $16 billion, with an additional $200 million foreign exchange impact. The company now anticipates other income and expense in 2025 to be approximately $100 million of income due to higher-than-expected royalties and favorable interest income.

As a result of these changes, the company is raising the midpoint of its 2025 non-GAAP EPS guidance by $0.15 per share to an expected range of $6.70 to $7.00.

The stated guidance revisions include the estimated impact of current tariffs on U.S. products shipped to China, but do not account for any potential pharmaceutical sector tariffs.

Non-GAAP2,3

February
(Prior)

April
(Updated)

Total Revenues

(Reported & Ex-FX)

~$45.5 billion

~$45.8 – $46.8 billion

Gross Margin %

~72%

No change

Operating Expenses1

~$16 billion

~$16.2 billion

Other income/(expense)

~$30 million

~$100 million

Effective tax rate

~18%

No change

Diluted EPS

$6.55-$6.85

$6.70-$7.00

1 Operating Expenses = SG&A and R&D.

2 See "Use of Non-GAAP Financial Information."

3 February was calculated using foreign exchange rates as of January 9, 2025, and April was calculated using foreign exchange rates as of April 23, 2025.

The 2025 financial guidance excludes the impact of any potential future strategic acquisitions, divestitures, specified items that have not yet been identified and quantified, and the impact of future Acquired IPRD charges and licensing income. To the extent we have quantified the impact of significant R&D charges or other income resulting from upfront or contingent milestone payments in connection with asset acquisitions or licensing of third-party intellectual property rights, we may update this information from time to time on our website www.bms.com, in the "Investors" section. Non-GAAP guidance assumes exchange rates as of the date noted. The financial guidance is subject to risks and uncertainties applicable to all forward-looking statements as described elsewhere in this press release.

A reconciliation of forward-looking non-GAAP measures, including non-GAAP EPS, to the most directly comparable GAAP measures is not provided because comparable GAAP measures for such measures are not reasonably accessible or reliable due to the inherent difficulty in forecasting and quantifying measures that would be necessary for such reconciliation. Namely, we are not, without unreasonable effort, able to reliably predict the impact of accelerated depreciation and impairment charges, legal and other settlements, gains and losses from equity investments and other adjustments. In addition, the company believes such a reconciliation would imply a degree of precision and certainty that could be confusing to investors. These items are uncertain, depend on various factors and may have a material impact on our future GAAP results. See "Cautionary Statement Regarding Forward-Looking Statements" and "Use of Non-GAAP Financial Information."

Conference Call Information
Bristol Myers Squibb will host a conference call today, Thursday, April 24, 2025, at 8:00 a.m. ET, during which company executives will review financial results with the investment community.

Investors and the general public are invited to listen to a live webcast of the call at View Source." target="_blank" title="View Source." rel="nofollow">View Source Materials related to the call will be available at View Source prior to the start of the conference call.

A replay of the webcast will be available at View Source approximately three hours after the conference call concludes.

Dizal to Showcase Data in Hematologic Malignancies and Lung Cancer at ASCO 2025

On April 24, 2025 Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, reported that the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting will feature the latest study results from the company’s investigational drugs DZD8586 and DZD6008 in B-cell non-Hodgkin lymphomas (B-NHLs) and non-small cell lung cancer (NSCLC) (Press release, Dizal Pharma, APR 24, 2025, View Source [SID1234652116]).

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The oral presentation includes results in B-NHLs from a pooled safety and efficacy analysis of two phase I/Ⅱ studies of DZD8586 in chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients with prior treatment of covalent and/or non-covalent BTK Inhibitors as well as BTK degraders.

While early clinical data showed encouraging anti-tumor activities from BTK degraders in CLL/SLL patients, resistance mutations to both BTK inhibitors and degraders have already been reported, and degrader-related toxicities may affect long-term clinical application. Data from Phase I/II studies of DZD8586 in CLL/SLL, presented at the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, showed that 94.4% of patients achieved tumor shrinkage at ≥50 mg QD. Significant tumor responses were also observed in other B-NHLs, including diffuse large B-cell lymphoma (DLBCL). Preliminary results from the ongoing phase Ⅱ study of DZD8586 monotherapy in patients with relapsed/refractory DLBCL will be presented at this ASCO (Free ASCO Whitepaper) meeting.

Dizal will also present Phase I/II data of DZD6008, a 4th generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) with full blood–brain barrier (BBB) penetration, in advanced EGFR mutation positive (EGFRm) NSCLC patients who failed prior 3rd generation EGFR TKI treatment. Lung cancer is a leading cause of brain metastases (BMs), with 10-20% of patients with NSCLC presenting with BMs at diagnosis and 25-50% developing them over the course of their disease. NSCLC patients whose disease progressed after 3rd generation EGFR TKI treatment often develop CNS metastasis and exhibit acquired EGFR resistance mutations. Preclinical data shows that DZD6008 demonstrates good safety and efficacy in NSCLC patients with brain metastases who had failed 3rd generation EGFR TKI therapy or multiple lines of pre-treatments.

"We are honored that our study results have been selected for oral presentations at ASCO (Free ASCO Whitepaper) for three consecutive years. Our presence at this congress highlights our commitment to addressing global unmet medical needs in hematological malignancies and lung cancer," said Xiaolin Zhang, PhD, CEO of Dizal. "We look forward to sharing positive clinical data of our novel medicines, which have the potential to bring clinical benefit to patients with limited treatment options."

Dizal presentation details during ASCO (Free ASCO Whitepaper) 2025:

Lead Author

Abstract Title

Presentation Details

Prof. Jianyong Li

Phase 1/2 Studies of DZD8586 in
CLL/SLL Patients after Covalent or
Non-covalent BTK Inhibitors and BTK
Degraders

Abstract #7010

Rapid Oral Abstract Session

May 31, 2025, 8:00-9:30 (CDT)

Prof. Mengzhao Wang

Phase 1/2 Study of DZD6008, a 4th-
Generation EGFR TKI with Full BBB
Penetration, in EGFR-mutant NSCLC

Abstract #8616

Poster Session

May 31, 2025, 13:30-16:30 (CDT)

Prof. Lugui Qiu

Phase 2 Study of DZD8586, a Non-
Covalent BBB Penetrant LYN/BTK
Dual Inhibitor, as Monotherapy in
Relapsed/Refractory Diffuse Large B-
Cell Lymphoma (r/r DLBCL) (TAI-
SHAN9)

Abstract #e19050

Online Publication

May 22, 2025, 17:00 (EDT)

About DZD8586
DZD8586 is a first-in-class, non-covalent, LYN/BTK dual inhibitor with full blood-brain barrier (BBB) penetration, designed as a potential treatment option for B-cell non-Hodgkin lymphoma (B-NHL).

While Bruton’s Tyrosine Kinase (BTK) inhibitors have been approved for the treatment of B-NHL, resistance can arise through two major mechanisms: the BTK C481X mutation and BTK-independent BCR signaling pathway activation. Currently, there is no targeted therapy available to address both resistance mechanisms, posing an urgent clinical challenge. Although BTK degraders have shown encouraging efficacy in early clinical studies, mutation-related resistance has been reported, and degrader-related toxicities may affect long-term clinical application.

DZD8586 has high selectivity against other TEC family kinases (TEC, ITK, TXK and BMX). By targeting BTK and LYN, it blocks both BTK-dependent and -independent BCR-signaling pathways, effectively inhibiting tumor growth of B-NHLs in cell lines and in animal models. Phase I clinical trial suggests that DZD8586 exhibits favorable PK properties, good central nervous system (CNS) permeability, complete blockade of BCR signaling, and encouraging anti-tumor efficacy with good safety and tolerability in patients with B-NHL.

About DZD6008
DZD6008 is a novel, highly selective, full-BBB penetrant EGFR TKI, designed as a potential treatment option for advanced EGFR mutation positive (EGFRm) NSCLC.

Non-small cell lung cancer is the leading cause of cancer death in the world. Epidermal growth factor receptor (EGFR) gene is one of the most common driver genes for NSCLC. Multiple agents can be used to treat patients with EGFR mutated NSCLC who develop resistance to EGFR tyrosine kinase inhibitors (TKIs), but the clinical outcome was not satisfactory. Brain metastases (BM) are a leading cause of death and disease progression for NSCLC. Approximately 23%-30% of NSCLC patients are synchronous BM at their initial diagnosis. Previous studies reported that the 3-year cumulative rate of BMs ranges from 29.4% to 60.3% in patients with mutated EGFR.

Currently, the clinical benefits of existing treatments for third-generation EGFR TKI-resistant NSCLC are limited and DZD6008 is expected to fill the unmet medical needs. DZD6008 effectively inhibits EGFR-mutated tumor growth in cell lines and in animal models. Previous clinical studies have validated the design concept of the molecule and suggest that DZD6008 demonstrates good safety and efficacy in NSCLC patients with brain metastases who had failed third-generation EGFR TKI therapy or multiple lines of pre-treatments.