On August 7, 2025 Eli Lilly and Company (NYSE: LLY) reported its financial results for the second quarter of 2025 (Press release, Eli Lilly, AUG 7, 2025, View Source [SID1234654974]).

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"Lilly delivered another quarter of strong performance, achieving 38% year-over-year revenue growth driven by robust sales of Zepbound and Mounjaro and sustained momentum across our key medicines," said David A. Ricks, Lilly chair and CEO. "Our pipeline continued to advance, highlighted by positive study results in oncology and cardiometabolic health—including Mounjaro’s demonstrated cardio-protective effects in patients with type 2 diabetes and heart disease and strong data for our oral incretin, orforglipron, in obesity. We also expanded manufacturing capacity to meet increasing demand and invested in key R&D initiatives to support our long-term growth."

Financial Results

$ in millions, except

per share data

Second-Quarter

2025

2024

% Change

Revenue

$ 15,557.7

$ 11,302.8

38 %

Net income – Reported

5,660.5

2,967.0

91 %

Earnings per share – Reported

6.29

3.28

92 %

Net income – Non-GAAP

5,679.3

3,541.2

60 %

Earnings per share – Non-GAAP

6.31

3.92

61 %

A discussion of the non-GAAP financial measures is included below under "Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information (Unaudited)."

Second-Quarter Reported Results
In Q2 2025, worldwide revenue was $15.56 billion, an increase of 38% compared with Q2 2024, driven by a 42% increase in volume, partially offset by a 6% decrease due to lower realized prices. Key Products1 revenue grew to $10.40 billion in Q2 2025, led by Zepbound and Mounjaro.

Revenue in the U.S. increased 38% to $10.81 billion, driven by a 46% increase in volume, partially offset by an 8% decrease due to lower realized prices. The increase in U.S. volume and decline in realized prices was driven by Zepbound and Mounjaro.

Revenue outside the U.S. increased 37% to $4.74 billion, driven by a 35% increase in volume and to a lesser extent a 3% favorable impact on foreign exchange rates, partially offset by a 1% decrease due to lower realized prices. The volume increase outside the U.S. was driven primarily by Mounjaro.

Gross margin increased 44% to $13.11 billion in Q2 2025. Gross margin as a percent of revenue was 84.3%, an increase of 3.5 percentage points. The increase in gross margin percent was primarily driven by improved cost of production and favorable product mix, partially offset by lower realized prices.

In Q2 2025, research and development expenses increased 23% to $3.34 billion, or 21.4% of revenue, driven by continued investments in the company’s early and late-stage portfolio.

Marketing, selling and administrative expenses increased 30% to $2.75 billion in Q2 2025, primarily driven by promotional efforts supporting ongoing and future launches.

There were no asset impairment, restructuring and other special charges in Q2 2025. In Q2 2024, there was a charge of $435.0 million, which related to litigation.

The effective tax rate was 16.5% in Q2 2025 compared with 15.6% in Q2 2024. The lower tax rate in Q2 2024 reflects the favorable tax impact of asset impairment, restructuring and other special charges in Q2 2024.

In Q2 2025, net income and earnings per share (EPS) were $5.66 billion and $6.29, respectively, compared with net income of $2.97 billion and EPS of $3.28 in Q2 2024. EPS in Q2 2025 and Q2 2024 both included acquired IPR&D charges of $0.14.

1 The Company defines Key Products as Ebglyss, Jaypirca, Kisunla, Mounjaro, Omvoh, Verzenio, and Zepbound.

Second-Quarter Non-GAAP Measures
On a non-GAAP basis, Q2 2025 gross margin increased 43% to $13.23 billion. Gross margin as a percent of revenue was 85.0%, an increase of 3.0 percentage points. The increase in gross margin percent was primarily driven by improved cost of production and favorable product mix, partially offset by lower realized prices.

On a non-GAAP basis, Q2 2025 net income and EPS were $5.68 billion and $6.31, respectively, compared with net income of $3.54 billion and EPS of $3.92 in Q2 2024. Non-GAAP EPS in Q2 2025 and Q2 2024 both included acquired IPR&D charges of $0.14.

For further detail on non-GAAP measures, see the reconciliation below as well as the "Reconciliation of GAAP Reported to Selected Non-GAAP Adjusted Information (Unaudited)" table later in this press release.

Second-Quarter

2025

2024

% Change

Earnings per share (reported)

$ 6.29

$ 3.28

92 %

Amortization of intangible assets

.11

.12

Asset impairment, restructuring and other
special charges

—

.38

Net losses (gains) on investments in equity
securities

(.09)

.14

Earnings per share (non-GAAP)

$ 6.31

$ 3.92

61 %

Acquired IPR&D

.14

.14

— %

Numbers may not add due to rounding

Selected Revenue Highlights

(Dollars in millions)

Second-Quarter

Year-to-Date

Selected Products

2025

2024

% Change

2025

2024

% Change

Mounjaro

$ 5,198.9

$ 3,090.8

68 %

$ 9,040.7

$ 4,897.4

85 %

Zepbound

3,381.4

1,243.2

172 %

5,693.3

1,760.6

NM

Verzenio

1,489.3

1,331.9

12 %

2,648.2

2,382.2

11 %

Total Revenue

15,557.7

11,302.8

38 %

28,286.2

20,070.8

41 %

NM – not meaningful

Mounjaro
For Q2 2025, worldwide Mounjaro revenue increased 68% to $5.20 billion. U.S. revenue was $3.30 billion, an increase of 37%, reflecting strong demand, partially offset by lower realized prices. Revenue outside the U.S. increased to $1.90 billion compared with $677.2 million in Q2 2024, primarily driven by volume growth, including entry into new markets.

Zepbound
For Q2 2025, U.S. Zepbound revenue increased 172% to $3.38 billion, compared with $1.24 billion in Q2 2024, primarily driven by increased demand, partially offset by lower realized prices.

Verzenio
For Q2 2025, worldwide Verzenio revenue increased 12% to $1.49 billion. U.S. revenue was $929.0 million, an increase of 8%, driven by increased volume. Revenue outside the U.S. was $560.3 million, an increase of 19%, primarily driven by volume growth.

Lilly shared numerous updates recently on key regulatory, clinical, business development and other events, including:

Regulatory

Donanemab receives positive opinion from the Committee for Medicinal Products
for Human Use (CHMP) in early symptomatic Alzheimer’s disease (announcement)

FDA approves updated label for Lilly’s Kisunla (donanemab-azbt) with new dosing
in early symptomatic Alzheimer’s disease (announcement).

FDA approves updated label for Lilly’s Amyvid (florbetapir F 18 injection) to support
diagnosis of Alzheimer’s disease in patients (announcement).

Lilly’s Kisunla (donanemab) receives marketing authorization in Australia for the
treatment of early symptomatic Alzheimer’s disease (announcement).

Clinical

Lilly’s oral GLP-1, orforglipron, delivers weight loss of up to an average of 27.3 lbs
in first of two pivotal Phase 3 trials in adults with obesity (announcement)

Lilly’s Mounjaro (tirzepatide), a GIP/GLP-1 dual agonist, demonstrated
cardiovascular protection in landmark head-to-head trial, reinforcing its benefit in
patients with type 2 diabetes and heart disease (announcement)

Lilly’s Kisunla (donanemab-azbt) showed growing benefit over three years in early
symptomatic Alzheimer’s disease (announcement)

Lilly’s Jaypirca (pirtobrutinib), the first and only approved non-covalent (reversible)
BTK inhibitor, met its primary endpoint in a head-to-head Phase 3 trial versus
Imbruvica (ibrutinib) in CLL/SLL (announcement)

Lilly’s once-weekly insulin efsitora alfa demonstrated A1C reduction and a safety
profile consistent with daily insulin in multiple Phase 3 trials (announcement).

Lilly’s oral GLP-1, orforglipron, showed compelling efficacy and a safety profile
consistent with injectable GLP-1 medicines, in complete Phase 3 results published
in The New England Journal of Medicine (announcement).

Lilly presents first clinical data for its investigational, next-generation FRα targeting
ADC in platinum-resistant ovarian cancer at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting
(announcement).

Zepbound (tirzepatide) showed superior weight loss over Wegovy (semaglutide) in
complete SURMOUNT-5 results published in The New England Journal of Medicine
(announcement).

Other

Lilly to acquire Verve Therapeutics to advance one-time treatments for people with
high cardiovascular risk (announcement). Lilly and Verve announce expiration of
Verve tender offer (announcement).

Lilly to offer all approved doses of Zepbound (tirzepatide) single-dose vials through
LillyDirect Self Pay Pharmacy Solutions (announcement).

Lilly to expand its pain pipeline with acquisition of SiteOne Therapeutics
(announcement).

Lilly plans to expand Purdue University collaboration with up to a $250 million
investment to accelerate pharmaceutical innovation (announcement).

Lilly announces transitions in executive leadership (announcement).

For information on important public announcements, visit the news section of Lilly’s website.

2025 Financial Guidance
Full year guidance increased to the range of $60.0 billion to $62.0 billion, primarily driven by strong underlying business performance across the portfolio and foreign exchange rates.

The performance margin2 is now expected to be in the range of 42.0% and 43.5% on a reported basis and 43.0% and 44.5% on a non-GAAP basis. Both ratios reflecting the increase in revenue guidance.

Other income (expense) on a reported basis is now expected to be expense in the range of $750 million to $650 million due to a decrease in net losses on investments in equity securities and is still expected to be expense in the range of $700 million to $600 million on a non-GAAP basis.

The 2025 estimated effective tax rate increased from approximately 17% on a reported basis to 19% which reflects an anticipated third quarter charge as a result of recently enacted U.S. tax legislation. The non-GAAP estimated tax rate is still expected to be approximately 17%.

Based on these changes, EPS guidance increased to the range of $20.85 to $22.10 on a reported basis and $21.75 to $23.00 on a non-GAAP basis. The company’s updated 2025 financial guidance reflects adjustments shown in the reconciliation table below.

Webcast of Conference Call
As previously announced, investors and the general public can access a live webcast of the Q2 2025 financial results conference call through a link on Lilly’s website at investor.lilly.com/webcasts-and-presentations. The conference call will begin at 8:30 a.m. Eastern time today and will be available for replay via the website.

On August 7, 2025 Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious hematologic diseases, reported financial results for the second quarter ended June 30, 2025, and provided a recap of recent program and corporate developments (Press release, Disc Medicine, AUG 7, 2025, View Source [SID1234654973]).

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"We are pleased with the continued momentum this past quarter, highlighted by clinical data presentations that support further advancement across our programs and continued progress toward our first NDA submission. Following positive feedback from our pre-NDA meeting, we are on track to submit an NDA for bitopertin in EPP under the accelerated approval pathway in October," said John Quisel, J.D., Ph.D., Chief Executive Officer and President of Disc. "We have also made great progress across the rest of our pipeline, initiating a Phase 2 study of DISC-3405 in polycythemia vera, and looking ahead to data from the Phase 2 trial of DISC-0974 in MF anemia and Phase 1b trial in NDD-CKD anemia in the second half of the year. Our team’s commitment to execution, supported by a strong balance sheet that provides cash runway into 2028, has positioned Disc to prepare for the potential commercialization of bitopertin and advance pipeline development as we enter the next phase of growth."

Recent Highlights and Anticipated Milestones:

Bitopertin: GlyTI Inhibitor (Heme Synthesis Modulator)

Presented data from HELIOS, an ongoing open-label extension study of bitopertin in EPP, which showed favorable long-term efficacy and safety with sustained protoporphyrin IX (PPIX) reductions, improvement in quality of life, and improved liver biomarkers
Progressing confirmatory Phase 3 APOLLO clinical trial of bitopertin in adults and adolescents with EPP
Completed positive pre-NDA meeting with FDA, confirming alignment with the agency on the expected timing, format, and content of planned NDA submission for bitopertin in EPP
Expect to submit an NDA in October 2025 under the FDA’s accelerated approval pathway based on Disc’s existing data package
Publication of the results from a preclinical study conducted in collaboration with Boston Children’s Hospital showing that, in mice, bitopertin may help prevent liver disease in EPP, in addition to ameliorating blood PPIX levels. The paper, "The GLYT1 inhibitor bitopertin mitigates erythroid PPIX production and liver disease in erythroid protoporphyria," was published in the Journal of Clinical Investigation (corresponding authors Sarah Ducamp and Paul Schmidt)
DISC-0974: Anti-Hemojuvelin Antibody (Hepcidin Suppression)

Hosted a virtual MF Anemia KOL event on May 9, 2025, discussing DISC-0974 and its potential to play a significant role in the treatment of anemia in patients with MF
A replay of the webcast is available on the Events & Presentations page on the investor relations portion of the Company website
Presented clinical data from the continuation phase of the Phase 1b trial of DISC-0974 in MF anemia demonstrating durable hematologic response at EHA (Free EHA Whitepaper) 2025
Progressing RALLY-MF Phase 2 study of DISC-0974 in patients with anemia of MF with initial data expected in Q4 2025
Exploratory cohort for patients on concomitant momelotinib or pacritinib fully enrolled, and trial protocol updated to allow patients on these therapies into the main study cohorts
Progressing Phase 1b study of DISC-0974 in patients with anemia of NDD-CKD with multiple-dose data expected in Q4 2025
DISC-3405: Anti-TMPRSS6 Antibody (Hepcidin Induction)

Presented updated SAD/MAD data from the Phase 1 trial of DISC-3405 in healthy volunteers providing proof of mechanism to support advancement of the program at EHA (Free EHA Whitepaper) 2025
Initiated a Phase 2 study of DISC-3405 in patients with PV with initial data expected in 2026
Corporate:

Appointed Nadim Ahmed, President and CEO of Cullinan Therapeutics, to the Company’s Board of Directors in July, bringing to the Company over 25 years of development and commercial leadership experience including multiple product launches in the hematology space
Second Quarter 2025 Financial Results:

Cash Position: Cash, cash equivalents, and marketable securities were $650.0 million as of June 30, 2025, which are expected to fund operational plans into 2028.
Research and Development Expenses: R&D expenses were $46.3 million for the three months ended June 30, 2025, as compared to $23.5 million for the three months ended June 30, 2024. The increase in R&D expenses was primarily driven by the progression of Disc’s portfolio, including bitopertin’s clinical studies and drug manufacturing, the advancement of the DISC-0974 program, and increased headcount, as well as a payment of a $10 million milestone upon initiation of the APOLLO study.
Selling, General and Administrative Expenses: SG&A expenses were $15.1 million for the three months ended June 30, 2025, as compared to $7.4 million for the three months ended June 30, 2024. The increase in SG&A expenses was primarily due to increased headcount including establishing infrastructure to support potential commercialization.
Net Loss: Net loss was $55.2 million for the three months ended June 30, 2025, as compared to $26.4 million for the three months ended June 30, 2024. The increase was primarily due to higher operating costs in the current period to support the continued advancement of our pipeline.

On August 7, 2025 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of masked, conditionally activated biologics, reported second quarter 2025 financial results and provided a business update (Press release, CytomX Therapeutics, AUG 7, 2025, View Source [SID1234654972]).

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"Q2 2025 was an exciting quarter for CytomX as we announced positive initial clinical results for CX-2051 in advanced colorectal cancer, a very challenging disease to treat. Our data highlight CX-2051’s intentional design as a first-in-class, masked EpCAM-directed ADC with potential to improve upon the standard of care in late-line CRC. We are also delighted to have completed a financing with top-tier investors that enables CytomX to rapidly advance the CX-2051 development program. Looking ahead, we remain highly focused on our next anticipated CX-2051 clinical data update in Q1 2026 and to potentially launching a Phase 2 study in the first half of 2026," said Sean McCarthy, D.Phil., chief executive officer and chairman of CytomX.

Q2 2025 Pipeline Program Updates:

CX-2051 (EpCAM PROBODY Topo-1 ADC)

Announced positive interim data from ongoing Phase 1 dose escalation study of first-in-class EpCAM Antibody Drug Conjugate (CX-2051) in patients with advanced colorectal cancer (CRC).
Initiated CX-2051 dose expansions at the 7.2 mg/kg, 8.6 mg/kg, and 10 mg/kg doses, administered every three weeks (Q3W).
Phase 1 data update in advanced CRC in approximately 70 patients is expected by Q1 2026.
Planning underway for CX-2051 Phase 2 study initiation in advanced, late-line CRC in 1H 2026.
Potential to initiate CX-2051 combination studies in earlier lines of CRC therapy in 2026.
Evaluation ongoing of multiple non-CRC, EpCAM-expressing tumor indications for potential future CX-2051 development.
CX-801 (PROBODY Interferon alpha-2b)

Phase 1 dose escalation of CX-801 monotherapy continues. Preliminary tumor biomarker, pharmacodynamic (PD) and pharmacokinetic (PK) data evaluating the initial molecular performance of CX-801 monotherapy in the ongoing Phase 1 study are expected in the fourth quarter of 2025.
In May 2025, Phase 1 dose escalation of CX-801 in combination with KEYTRUDA was initiated. Initial clinical data for the combination therapy in advanced melanoma is anticipated in 2026.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA

Corporate and Financial:

Financial:
Completed $100 million ($93.4 million net proceeds) underwritten offering of common stock.
CytomX ended the second quarter of 2025 with $158.1 million of cash, cash equivalents and investments with expected cash runway to the second quarter of 2027.
Research collaborations:
Presented preclinical data for mRNA encoded masked IL-12 molecule in collaboration with Moderna at AACR (Free AACR Whitepaper) Annual Meeting showing potent anti-tumor activity with significantly enhanced tolerability vs. unmasked IL-12 molecule.
Multiple drug discovery programs continue across our research collaborations with a focus on bispecific immunotherapies, including T-cell engagers. CytomX has research collaborations with Bristol Myers Squibb, Amgen, Astellas, Regeneron, and Moderna.
Second Quarter 2025 Financial Results:

Cash, cash equivalents and investments totaled $158.1 million as of June 30, 2025, compared to $79.9 million as of March 31, 2025.

Total revenue was $18.7 million for the quarter ended June 30, 2025, compared to $25.1 million for the quarter ended June 30, 2024. The decrease in revenue was driven primarily by the completion of our performance obligations in the Bristol Myers Squibb collaboration, the decision not to further develop the CX-904 program in the Amgen agreement, and a decrease in Moderna activities due to Moderna budget considerations.

Total operating expense in the second quarter of 2025 was $19.9 million compared to $33.6 million in the second quarter of 2024, a decrease of $13.7 million.

Research and development expenses were $13.3 million for the three months ended June 30, 2025, a decrease of $11.9 million compared to the corresponding period of 2024. Reduced research and development expenses were primarily due to a one-time milestone payment of $5M to Immunogen for the first patient dosed in Phase 1 with CX-2051 in Q2 2024, a reduction in CX-904 spend due to program de-prioritization in 2025, and reduced research expenses following the Q1 2025 restructuring.

General and administrative expenses were $6.6 million for the three months ended June 30, 2025, a decrease of $1.8 million compared to the corresponding period of 2024. The decrease in general and administrative expenses was primarily driven by personnel costs as well as patent and legal expenses.

On August 7, 2025 Cullinan Therapeutics, Inc. (Nasdaq: CGEM; "Cullinan"), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, reported an update on recent and anticipated business highlights and announced its financial results for the second quarter ended June 30, 2025 (Press release, Cullinan Oncology, AUG 7, 2025, View Source [SID1234654971]).

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"I am proud of the team’s strong execution throughout the first half of the year as we continue to advance the CLN-978 program across three active studies in SLE, RA, and Sjögren’s disease. With the addition of velinotamig, we further solidified our leadership position in the development of T cell engagers for autoimmune diseases. With these two programs, our portfolio covers the entire breadth of the B cell compartment. Recent data presented at the European Alliance of Associations for Rheumatology (EULAR) meeting reinforced the potential of T cell engagers as disease-modifying therapies across a wide spectrum of autoimmune diseases," said Nadim Ahmed, Chief Executive Officer of Cullinan Therapeutics.

"We also continue making important progress across our oncology portfolio, recently sharing results from the pivotal Phase 2b portion of the REZILIENT1 study of zipalertinib at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting, and we look forward to sharing multiple new data sets at upcoming medical conferences. Pending discussions with the U.S. FDA, our partner Taiho plans to submit an NDA in relapsed EGFR ex20ins NSCLC later this year and expects to complete enrollment of the frontline study REZILIENT3 in the first half of 2026. We also plan to share clinical data for CLN-049, our FLT3xCD3 bispecific T cell engager, in patients with relapsed/refractory AML and MDS later this year. With $510.9 million in cash and investments and runway into 2028, we have the resources to generate multiple value-driving catalysts near term and beyond across both our immunology and oncology programs. Lastly, I am pleased to welcome Drs. Mittie Doyle and Andrew Allen to our Board of Directors. They are proven leaders with deep strategic and development expertise in immunology and oncology, respectively, and I believe their contributions will be invaluable as we continue to advance our programs. I would also like to thank Drs. Anne-Marie Martin and David Ryan for their contributions to our progress and success over the last several years."

Portfolio Highlights

Immunology

•
CLN-978 (CD19xCD3 bispecific T cell engager): Systemic lupus erythematosus, rheumatoid arthritis, and Sjögren’s disease
o
The global Phase 1 study in patients with moderate to severe SLE is enrolling in the United States, Europe, and Australia, and the Company plans to share initial safety data and B cell depletion data from Part A of the study in Q4 2025.
o
The Phase 1 study in patients with active, difficult-to-treat rheumatoid arthritis is enrolling in Europe. This company-sponsored study is being led by sites at FAU Erlangen-Nuremberg in Germany and Università Cattolica del Sacro Cuore in Italy. The Company plans to share initial data from this study during the first half of 2026.
o
The global Phase 1 study in patients with active, moderate to severe Sjögren’s disease is enrolling in the U.S. and is now also active in Europe following recent regulatory approval.

•
Velinotamig (BCMAxCD3 bispecific T cell engager): Autoimmune diseases
o
In June 2025, the Company entered into an agreement with Genrix Bio for an exclusive global (ex-Greater China) license to velinotamig. Under the agreement, Cullinan paid Genrix Bio an upfront license fee of $20 million. In the future, Genrix Bio will also be eligible to receive up to $292 million in development and regulatory milestones plus up to an additional $400 million in sales-based milestones, as well as tiered royalties on potential ex-Greater China net sales.
o
Genrix Bio plans to initiate a Phase 1 study in patients with autoimmune diseases in China by the end of 2025. Cullinan intends to use the data generated to accelerate global clinical development of the program. Following the completion of the Genrix Bio Phase 1 study, Cullinan will conduct all further development of velinotamig in autoimmune diseases.
Oncology

•
Zipalertinib (EGFR ex20ins inhibitor), collaboration with Taiho Oncology: EGFR ex20ins NSCLC
o
In June 2025, results from the pivotal Phase 2b portion of REZILIENT1 in patients with EGFR ex20ins NSCLC who have received prior therapy were shared at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting and published simultaneously in the Journal of Clinical Oncology. Cullinan plans to share updated efficacy and safety data in patients previously treated with amivantamab during a mini oral abstract session at the IASLC 2025 WCLC.
o
Pending discussions with the U.S. Food and Drug Administration, Taiho plans to submit an NDA in relapsed EGFR ex20ins NSCLC by the end of 2025. Taiho expects to complete enrollment of the pivotal study REZILIENT3 in 1L EGFR ex20ins NSCLC in the first half of 2026.
o
Taiho plans to share initial data from the REZILIENT2 cohort exploring zipalertinib in patients with uncommon EGFR mutations during a mini oral abstract session at the IASLC 2025 WCLC. Taiho also plans to share initial data from the REZILIENT2 cohort exploring zipalertinib in patients with active brain metastases at the ESMO (Free ESMO Whitepaper) Congress 2025.

•
CLN-049 (FLT3xCD3 bispecific T cell engager): Acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)
o
Enrollment continues in the Phase 1 study in patients with relapsed/refractory AML or MDS and the company plans to share clinical data from this study in Q4 2025.
o
Enrollment also continues in the Phase 1 study in patients with measurable minimal residual disease in AML.
•
CLN-619 (Anti-MICA/MICB monoclonal antibody): NSCLC and multiple myeloma
o
Enrollment continues in the Phase 1 expansion cohorts in patients with NSCLC and the Phase 1 study in patients with relapsed/refractory multiple myeloma.
•
CLN-617 (IL-2 and IL-12 cytokine fusion protein): Solid tumors
o
Enrollment continues in the Phase 1 study in patients with advanced solid tumors.
Corporate Updates

•
Mittie Doyle, M.D., and Andrew Allen, M.D., Ph.D., were appointed to the Board of Directors, effective August 7, 2025. Both board directors bring significant leadership experience, with Dr. Doyle having extensive immunology clinical development expertise, and Dr. Allen with extensive oncology clinical development experience. Anne-Marie Martin, Ph.D., and David Ryan, M.D., will resign from Cullinan’s Board of Directors effective August 7, 2025.
Second Quarter 2025 Financial Results

•
Cash Position: Cash, cash equivalents, short- and long-term investments, and interest receivable were $510.9 million as of June 30, 2025. Cullinan continues to expect its cash resources to provide runway into 2028 based on its current operating plan.
•
R&D Expenses: Research and development expenses were $61.0 million for the second quarter of 2025, compared to $36.3 million for the same period in 2024.
•
G&A Expenses: General and administrative expenses were $14.8 million for the second quarter of 2025, compared to $13.8 million for the same period in 2024.
•
Net Loss: Net loss attributable to Cullinan was $70.1 million for the second quarter of 2025, compared to $42.0 million for the same period in 2024.

On August 7, 2025 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a global pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for endocrine diseases and endocrine-related tumors, reported financial results for the second quarter ended June 30, 2025 (Press release, Crinetics Pharmaceuticals, AUG 7, 2025, View Source [SID1234654970]).

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"We continue to make significant progress towards our goal of becoming a fully-integrated, commercial-stage company and delivering on our commitment to help people living with acromegaly," said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics. "As we approach our PDUFA date, our interactions with the FDA remain on track. In addition to our world-class drug discovery and development capabilities, we have now nearly completed the build-out of a premier commercial organization. We are committed to rapidly making PALSONIFY available as the new level of care for patients upon approval. At the same time, we remain dedicated to the execution of early- and late-stage trials across our pipeline. I am excited to see the ramp of our late-stage trials in carcinoid syndrome and CAH (both adult and pediatric), as well as initiation of the Phase 1/2 trial of our first nonpeptide drug-conjugate, CRN09682, for SST2-expressing solid tumors. Overall, Crinetics is in the strongest position in its history, with unprecedented momentum across our clinical programs, multiple new candidates approaching the clinic, a solid financial foundation, and a clear path toward delivering transformative therapies to patients."

Second Quarter 2025 and Recent Highlights:

The review process for paltusotine’s New Drug Application (NDA) for acromegaly remains on track with consistent and productive engagement with the Food & Drug Administration (FDA).
Marketing Authorization Application (MAA) validated by the European Medicines Agency (EMA) for paltusotine for the treatment of acromegaly, consistent with a timeline for potential EMA decision in the first half of 2026.
Continued progress on the global development program for atumelnant across multiple trials, including enrollment completion of Cohort 4 of the adult Phase 2 study with data expected early in 2026.
The Phase 2/3 BALANCE-CAH pediatric study is seamlessly designed to expedite development with the goal of demonstrating atumelnant’s potential ability to normalize androstenedione (A4) levels with physiological glucocorticoid (GC) replacement.
Presented two abstracts at the American Association of Clinical Endocrinology (AACE) Annual Meeting 2025 which showed treatment with investigational PALSONIFY resulted in rapid and durable IGF-1 control in surgically naïve acromegaly patients and additional research on symptom burden and standard-of-care discontinuation rates.
Eight abstracts from Crinetics’ novel clinical development programs, including oral presentations featuring lead investigational drug candidate, paltusotine, investigational candidate atumelnant, and CRN12755, the early-stage development program in Graves’ hyperthyroidism and orbitopathy, were presented at the Endocrine Society’s Annual Meeting, ENDO 2025.
Key Upcoming Milestones:
FDA PDUFA target action date of September 25, 2025 for paltusotine NDA for the treatment of acromegaly.
Crinetics expects to initiate the CAREFNDR Phase 3 trial of paltusotine in carcinoid syndrome in the second half of 2025.
Crinetics expects to initiate the CALM-CAH Phase 3 study in adults with CAH and the BALANCE-CAH Phase 2/3 study in pediatrics in the second half of 2025.
Planning, including regulatory interactions, for the next study of atumelnant in ACTH-dependent Cushing’s syndrome is underway. Initiation of the Phase 2/3 study is expected to begin in the first half of 2026.
Crinetics expects to initiate a Phase 1/2 dose escalation study for CRN09682, the first candidate from the nonpeptide drug conjugate (NDC) platform with an expansion phase for the treatment of metastatic or locally advanced SST2-positive neuroendocrine tumors (NETs) and other SST2-expressing solid tumors.
IND-enabling activities for the TSH antagonist continue as expected, and development of the SST3 agonist and PTH antagonist is ongoing.
Second Quarter 2025 Financial Results:
Revenues were $1.0 million for the quarter ended June 30, 2025, compared to $0.4 million for the same period in 2024. Revenues were derived from the paltusotine licensing and supply agreements with Sanwa Kagaku Kenkyusho Co., Ltd.

Research and development expenses were $80.3 million for the three months ended June 30, 2025, compared to $58.3 million for the same period in 2024. The increases were primarily attributable to an increase in personnel costs of $9.6 million and increased clinical and manufacturing activities costs of $7.9 million for the quarter ended June 30, 2025, respectively, driven by the advancement of our clinical programs and the expansion of our preclinical portfolio.
Selling, general and administrative expenses were $49.8 million for the three months ended June 30, 2025, compared to $24.8 million for the same period in 2024. The increases were primarily driven by an increase in personnel costs of $12.0 million primarily due to the increase in headcount and an increase in outside services costs of $10.3 million primarily for commercial planning for the quarter ended June 30, 2025, respectively, to support our overall growth and the planned commercial launch of PALSONIFY
Net loss for the three months ended June 30, 2025, was $115.6 million, compared to a net loss of $74.1 million for the same period in 2024.

Cash, cash equivalents, and investments totaled $1.2 billion as of June 30, 2025, compared to $1.4 billion as of December 31, 2024. Based on current projections, Crinetics expects that its cash, cash equivalents and investments will be sufficient to fund its current operating plan into 2029. For 2025, we now anticipate our cash used in operations to be between $340 and $370 million.

Conference Call and Webcast Details

Management will hold a live conference call and webcast today, Thursday, August 7 at 4:30 p.m. ET. To participate, please dial 1-833-470-1428 (domestic) or 1-404-975-4839 (international) and refer to Access Code 899803. To access the webcast, the direct link (here) or visit the Events page of the Crinetics website. Following the live event, the webcast will be archived on the Investor Relations section of www.crinetics.com.