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.

Caribou Biosciences Announces Strategic Pipeline Prioritization with Focus on CB-010 and CB-011 Oncology Programs

On April 24, 2025 Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, reported a strategic pipeline prioritization with workforce and cost reduction initiatives to focus resources on its lead oncology clinical programs CB-010 and CB-011, with clinical data disclosures now planned for H2 2025 (Press release, Caribou Biosciences, APR 24, 2025, View Source [SID1234652100]).

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"Broad patient access to life-changing CAR-T cell therapies is only achievable if healthcare systems have an off-the-shelf option. Caribou’s two lead Phase 1 clinical programs, CB-010 for large B cell lymphoma and CB-011 for multiple myeloma, continue to demonstrate encouraging efficacy and have the potential to serve this critical unmet need for individuals living with hematologic malignancies," said Rachel Haurwitz, PhD, Caribou’s president and CEO. "We recognize the challenges in the current market environment and believe the best approach is to present the most robust datasets for both programs. As a result, we now plan to disclose clinical data from CB-010 and CB-011 in the second half of this year."

"To ensure Caribou is strongly positioned to emerge from these challenging times and deliver these potentially value-generating datasets, we have made the difficult decision to strategically prioritize our resources on CB-010 and CB-011 for oncology indications," continued Dr. Haurwitz. "These strategic decisions resulted in a reduction in Caribou’s workforce, which include some of the industry’s most talented scientists and professionals. We are deeply grateful for their foundational contributions to Caribou’s technology and current clinical programs. We plan to honor that legacy as we work toward ushering in a new era of allogeneic CAR-T cell therapies that offer the potential for broad access and rapid availability to both patients and healthcare systems."

Clinical highlights
CB-010, a clinical-stage allogeneic anti-CD19 CAR-T cell therapy for B cell non-Hodgkin lymphoma
•Caribou is enrolling a 20-patient confirmatory cohort using the company’s HLA matching strategy in the ANTLER Phase 1 clinical trial in second-line large B cell lymphoma (2L LBCL). In H2 2025, Caribou expects to present data from this cohort with at least 6 months of follow up for the majority of patients.
•To date, data demonstrate that a single dose of CB-010 has the potential to drive outcomes that are on par with the safety, efficacy, and durability of approved autologous CAR-T cell therapies.
•Additionally, in H2 2025, Caribou expects to present data from a proof-of-concept cohort of CB-010 in up to 10 patients who have relapsed following any prior CD19-targeted therapy.

CB-011, a clinical-stage allogeneic anti-BCMA CAR-T cell therapy for multiple myeloma
•In the dose escalation portion of the CaMMouflage Phase 1 clinical trial for relapsed or refractory multiple myeloma (r/r MM), Caribou continues to observe encouraging efficacy in patients treated with CB-011 at multiple dose levels following a lymphodepletion regimen that includes a deeper dose of cyclophosphamide.
•Caribou is rapidly enrolling additional patients with the deeper lymphodepletion regimen to make a data-driven decision on the recommended doses for expansion. The company plans to present data in H2 2025 with at least three months of follow up on a minimum of 25 patients at multiple dose levels.

Pipeline prioritization with workforce and cost reduction initiatives
•Caribou is prioritizing its lead oncology programs, CB-010 and CB-011. Caribou is discontinuing the GALLOP Phase 1 trial of CB-010 for lupus prior to dosing the first patient. Caribou is also discontinuing the AMpLify Phase 1 clinical trial of CB-012 for relapsed or refractory acute myeloid leukemia (AML) as additional data would be needed to advance this program, taking time and resources that can be dedicated to CB-010 and CB-011. Patients treated in the AMpLify Phase 1 trial will continue to be followed as part of the company’s long-term follow up study. Additionally, the company is discontinuing preclinical research.
•The company is reducing its workforce by approximately 32%. Cash payments resulting from the reduction in force and strategic pipeline prioritization are estimated to be $2.5 to $3.5 million.
•These changes are expected to extend Caribou’s cash runway by one year, funding the company’s current operating plan into H2 2027, compared to into H2 2026 as previously reported.

Corporate update
$212.5 million in cash, cash equivalents, and marketable securities
•Based on preliminary unaudited financial information, Caribou expects to report $212.5 million in cash, cash equivalents, and marketable securities as of March 31, 2025.

2025 Anticipated milestones
•CB-010 ANTLER: Caribou plans to present data from both the additional 2L and prior CD19 relapsed LBCL patient cohorts in H2 2025 and is interacting with the FDA on a potential pivotal trial to be initiated following alignment. This update is expected to include:
◦Initial safety and efficacy data on the confirmatory cohort (20 patients) with partial HLA matching, with a minimum of six months of follow up for the majority of patients, as well as an update on the larger, maturing dataset presented previously.
◦Pivotal trial design and timeline, contingent on positive data and FDA alignment.
•CB-011 CaMMouflage: Caribou plans to present dose escalation data and share the recommended doses for expansion from the ongoing CaMMouflage Phase 1 clinical trial in r/r MM in H2 2025. This update is expected to include:
◦Initial safety and efficacy data on a minimum of 25 patients at multiple dose levels using the deeper lymphodepletion regimen with at least three months of follow up.
◦Recommended doses for expansion and plans for dose expansion.

About CB-010
CB-010 is an allogeneic anti-CD19 CAR-T cell therapy being evaluated in patients with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL) in the ongoing ANTLER Phase 1 clinical trial. To Caribou’s knowledge, CB-010 is the first allogeneic CAR-T cell therapy in the clinic with a PD-1 knockout, a genome-editing strategy designed to enhance CAR-T cell activity by limiting premature CAR-T cell exhaustion. The FDA granted CB-010 Regenerative Medicine Advanced Therapy (RMAT), Orphan Drug, and Fast Track designations for B-NHL. Additional information on the ANTLER trial (NCT04637763) can be found at clinicaltrials.gov.

About CB-011
CB-011 is an allogeneic anti-BCMA CAR-T cell therapy being evaluated in patients with relapsed or refractory multiple myeloma (r/r MM) in the CaMMouflage Phase 1 trial. To Caribou’s knowledge, CB-011 is the first allogeneic CAR-T cell therapy in the clinic that is engineered to enable activity through an immune cloaking strategy with a B2M knockout and insertion of a B2M–HLA-E fusion protein to blunt immune-mediated rejection. CB-011 has been granted Fast Track and Orphan Drug designations by the FDA. Additional information on the CaMMouflage trial (NCT05722418) can be found at clinicaltrials.gov.

Kelun-Biotech to Present Results of Six Clinical Studies at 2025 ASCO Annual Meeting

On April 24, 2025 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (6990.HK) reported that it will present results from six Kelun-led clinical studies at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, held in Chicago from May 30 to June 3 (Press release, Kelun, APR 24, 2025, View Source [SID1234652117]). Results include data from its TROP2 antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT), anti-PD-L1 mAb tagitanlimab, and RET inhibitor KL590586 (A400/EP0031). The abstracts for these studies will be published on the ASCO (Free ASCO Whitepaper)’s official website on May 22, 2025, local time.

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Detailed information on the studies selected for ASCO (Free ASCO Whitepaper) 2025 are as follows:

Title: Sacituzumab tirumotecan (sac-TMT) in patients (pts) with previously treated advanced EGFR-mutated non-small cell lung cancer (NSCLC): Results from the randomized OptiTROP-Lung03 study.
Presentation Type: Oral
Abstract Number: 8507
Session Date and Time: 6/1/2025 8:00 AM-11:00 AM CDT

Title: Tagitanlimab versus placebo in combination with gemcitabine and cisplatin as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma (R/M NPC): Results from a randomized, double-blind, phase 3 study.
Presentation Type: Oral
Abstract Number: 6004
Session Date and Time: 5/31/2025 1:15 PM-4:15 PM CDT

Title: Sacituzumab tirumotecan (sac-TMT) as first-line treatment for unresectable locally advanced/metastatic triple-negative breast cancer (a/m TNBC): Initial results from the Phase II OptiTROP-Breast05 study.
Presentation Type: Rapid oral
Abstract Number: 1019
Session Date and Time: 5/30/2025 2:45 PM-4:15 PM CDT

Title: Sacituzumab tirumotecan (sac-TMT) in combination with tagitanlimab (anti-PD-L1) in first-line (1L) advanced non-small-cell lung cancer (NSCLC): Non-squamous cohort from the phase II OptiTROP-Lung01 study.
Presentation Type: Poster
Abstract Number: 8529
Session Date and Time: 5/31/2025 1:30 PM-4:30 PM CDT

Title: Sacituzumab Tirumotecan (sac-TMT) in patients (pts) with previously treated locally advanced or metastatic (LA/M) non-small cell lung cancer (NSCLC) harboring uncommon EGFR mutations: Preliminary results from a phase 2 study.
Presentation Type: Poster
Abstract Number: 8615
Session Date and Time: 5/31/2025 1:30 PM-4:30 PM CDT

Title: Results from a phase I study of KL590586 in patients with advanced RET-mutant medullary thyroid cancer.
Presentation Type: Poster
Abstract Number: 6098
Session Date and Time: 6/2/2025 9:00 AM-12:00 PM CDT

About Sac-TMT

Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as Non-small Cell Lung Cancer (NSCLC), breast cancer (BC), gastric cancer (GC), gynecological tumors, among others. Sac-TMT is developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells.

In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc., Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (includes Mainland China, Hong Kong, Macau, and Taiwan).

To date, two indications for sac-TMT have been approved and marketed in China for the treatment of adult patients with unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting) and EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy. Sac-TMT became the first domestic ADC with global intellectual property rights to be fully approved for marketing. It is also the world’s first TROP2 ADC to be approved for marketing in a lung cancer indication. In addition, the NDA application for sac-TMT for the treatment of adult patients with EGFR-mutant locally advanced or metastatic NSCLC who progressed after treatment with EGFR-TKI therapy was accepted by the National Medical Products Administration (NMPA), and was included in the priority review and approval process. As of today, Kelun-Biotech has initiated 8 registrational clinical studies in China. MSD has initiated 12 ongoing Phase 3 global clinical studies of sac-TMT as a monotherapy or with pembrolizumab or other agents for several types of cancer. These studies are sponsored and led by MSD.

About Tagitanlimab

Tagitanlimab is the first PD-L1 monoclonal antibody (mAb) globally to receive authorization for the first-line treatment of NPC. Previously, the National Medical Products Administration (NMPA) has approved the marketing in China of tagitanlimab used in combination with cisplatin and gemcitabine for the first-line treatment of patients with R/M NPC and monotherapy for the treatment of patients with recurrent or metastatic NPC who have failed after prior 2L+ chemotherapy, respectively.

About KL590586 (A400/EP0031)

A400, a novel next-generation selective RET inhibitor for NSCLC, MTC and other solid tumors with a high prevalence of RET alterations. We are currently conducting pivotal clinical study for both 1L and 2L+ advanced RET+ NSCLC as well as a phase 1b/2 clinical study for RET+ MTC and solid tumor in China.

In March 2021, we granted Ellipses Pharma, a U.K.-based international oncology drug development company, an exclusive license to develop, manufacture and commercialize this agent outside Greater China and certain Asian countries under the code EP0031.

In March 2024, it was announced that EP0031/A400 was granted Fast Track designation by the FDA for the treatment of RET-fusion positive NSCLC. In April 2024, EP0031/A400 was cleared by the FDA to progress into Phase 2 clinical development and is now open in the US, UK, EU and UAE.

Innate Pharma Regains Its Rights on CD123 Targeting ANKET® and Announces Sanofi’s Intention to Make a Strategic Investment in the Company

On April 23, 2025 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported review of their January 2016 Research Collaboration and License Agreement (the "2016 Agreement") with Sanofi (Press release, Innate Pharma, APR 23, 2025, View Source [SID1234652025]):

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As previously disclosed and in alignment with its current strategic priorities, Sanofi will opt to pursue the development of SAR’514/IPH6401 (BCMA ANKET) in autoimmune indications under the terms of the 2016 License Agreement;
In alignment with both company’s current strategic priorities, Sanofi and Innate agreed to terminate the 2016 Agreement as it relates to SAR’579/IPH6101 (CD123 ANKET); Innate will regain its rights on SAR’579/IPH6101 (CD123 ANKET).
As part of these discussions, Sanofi and Innate have agreed to a potential investment by Sanofi of up to €15M in new shares of Innate. The size and price of this equity investment will be determined on the basis of the ongoing market conditions, if they are satisfactory.

The 2022 research collaboration and license agreement remain unchanged.

"We are very pleased that Sanofi has chosen to further strengthen our relationship through a potential strategic equity investment in the company. This would further validate the innovation and scientific progress at Innate Pharma delivered by our research and development. We acknowledge Sanofi’s portfolio prioritization, and we are encouraged to see our ANKET platform being pursued in autoimmune indications. We will continue to evaluate, plan and execute next steps for our proprietary ANKET programs in oncology and beyond," said Jonathan Dickinson, Chief Executive Officer of Innate Pharma.

SAR’579 (NCT05086315)/IPH6101

The originally Sanofi-led Phase 1/2 study with SAR’579 / IPH6101 (clinical study identifier: NCT05086315) is ongoing. Efficacy and safety results from the dose-escalation part, were shared in an oral presentation at the EHA (Free EHA Whitepaper) 2024 Congress. The data demonstrated that SAR’579 had clinical benefit and durable responses along with a favorable safety profile in patients with relapsed or refractory acute myeloid leukemia (AML), with 5 complete responses (4 CR / 1 CRi) achieved at 1 mg/kg, with durable CR (>10 months) observed in 3 patients.
In April 2024, Sanofi advanced SAR’579 / IPH6101 to the Phase 2 preliminary dose expansion of the trial.
The Parties will discuss a transition plan with regard to ongoing studies.
SAR’514/IPH6401:

The continued Sanofi-led Phase 1/2 study (clinical study identifier: NCT05839626) for the treatment of patients with relapsed or refractory multiple myeloma will be terminated early and SAR’514/IPH6401 will now be refocused to pursue development in autoimmune indications.
IPH62 and one additional target

IPH62 is a NK-cell engager program targeting B7-H3 under development from Innate’s ANKET platform. Following a research collaboration period and upon candidate selection, Sanofi will be responsible for all development, manufacturing and commercialization.
Sanofi still retains the option of one additional ANKET target under the terms of the 2022 research collaboration and license agreement.