On May 8, 2025 IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage company in Phase 3 development with its DNA-mediated immunotherapy, reported that the first trial site has been initiated for the Company’s Phase 3 pivotal study, called OVATION 3, of its lead candidate IMNN-001 in development for the treatment of women with newly diagnosed advanced ovarian cancer (Press release, IMUNON, MAY 8, 2025, View Source [SID1234652746]). The first trial site is Washington University School of Medicine, and IMUNON is currently initiating additional trial sites and working with investigators to begin enrolling study participants.

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"This represents a significant step forward for the IMNN-001 development program as we work toward bringing patients this novel IL-12 immunotherapy, the first and only product to show meaningful overall survival benefit in women newly diagnosed with advanced ovarian cancer who have not seen changes in standard of care treatment in more than 25 years," said Premal H. Thaker, M.D., Interim Chief of Gynecologic Oncology, David & Lynn Mutch Distinguished Professor of Obstetrics & Gynecology, Director of Gynecologic Oncology Clinical Research at Washington University School of Medicine, and study-level principal investigator of the OVATION 3 trial. "It has been rewarding to be part of IMNN-001’s development for more than a decade and see the progress being made, with highly encouraging data from the Phase 2 study including in women treated with PARP inhibitors as maintenance therapy. I look forward to helping advance the OVATION 3 trial and seeing the results."

The Phase 3 OVATION 3 trial will assess the safety and efficacy of IMNN-001 (100 mg/m2 administered intraperitoneally weekly) plus neoadjuvant and adjuvant chemotherapy (N/ACT) of paclitaxel and carboplatin compared to standard of care (SoC) N/ACT alone. Study participants will be randomized 1:1 and include women with newly diagnosed advanced ovarian cancer (stage 3C or 4) who are eligible for neoadjuvant therapy, the intent-to-treat (ITT) population, with a sub-group of women positive for homologous recombination deficiency (HRD), including BRCA1 or BRCA2 mutations. Participants who are HRD positive will receive poly ADP-ribose polymerase (PARP) inhibitors as part of standard maintenance therapy. The primary endpoint of the study is overall survival (OS), and secondary endpoints are surgical response score, chemotherapy response score, clinical response and time to second-line treatment. The study will also assess several exploratory endpoints.

In December 2024, the Company reported additional clinical data from ongoing analyses of results from the Phase 2 OVATION 2 Study of IMNN-001. IMUNON will highlight new IMNN-001 data from OVATION 2 in an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held May 30 – June 3, 2025, in Chicago, Illinois.

"Initiating the first site for our Phase 3 pivotal trial is an important milestone in our efforts to make IMNN-001 available to women who receive the devastating diagnosis of advanced ovarian cancer and are in urgent need of additional treatment options," said Stacy Lindborg, Ph.D., president and chief executive officer of IMUNON. "We are grateful for the continued dedication and support of our team, the investigators and, most importantly, the participants in our clinical trials and their families to help get us to where we are today. Together, we look forward to this next stage of development for IMNN-001, with the latest results bringing new hope that this therapy may make a meaningful difference in people’s lives."

About the Phase 2 OVATION 2 Study

OVATION 2 evaluated the dosing, safety, efficacy and biological activity of intraperitoneal administration of IMNN-001 in combination with neoadjuvant and adjuvant chemotherapy (N/ACT) of paclitaxel and carboplatin in patients newly diagnosed with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer. Treatment in the neoadjuvant period is designed to shrink the tumors as much as possible for optimal surgical removal after three cycles of chemotherapy. Following N/ACT, patients undergo interval debulking surgery, followed by three additional cycles of adjuvant chemotherapy to treat any residual tumor. This open-label study enrolled 112 patients who were randomized 1:1 and evaluated for safety and efficacy to compare N/ACT plus IMNN-001 versus standard-of-care N/ACT. In accordance with the study protocol, patients randomized to the IMNN-001 treatment arm could receive up to 17 weekly doses of 100 mg/m2 in addition to N/ACT. As a Phase 2 study, OVATION 2 was not powered for statistical significance. Additional endpoints included objective response rate, chemotherapy response score and surgical response.

About IMNN-001 Immunotherapy

Designed using IMUNON’s proprietary TheraPlas platform technology, IMNN-001 is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system that enables cell transfection followed by persistent, local secretion of the IL-12 protein. IL-12 is one of the most active cytokines for the induction of potent anticancer immunity acting through the induction of T-lymphocyte and natural killer cell proliferation. IMUNON previously reported positive safety and encouraging Phase 1 results with IMNN-001 administered as monotherapy or as combination therapy in patients with advanced peritoneally metastasized primary or recurrent ovarian cancer and completed a Phase 1b dose-escalation trial (the OVATION 1 Study) of IMNN-001 in combination with carboplatin and paclitaxel in patients with newly diagnosed ovarian cancer. IMUNON previously reported positive results from the recently completed Phase 2 OVATION 2 Study, which assessed IMNN-001 (100 mg/m2 administered intraperitoneally weekly) plus neoadjuvant and adjuvant chemotherapy (N/ACT) of paclitaxel and carboplatin compared to standard-of-care N/ACT alone in 112 patients with newly diagnosed advanced ovarian cancer.

About Epithelial Ovarian Cancer

Epithelial ovarian cancer is the sixth deadliest malignancy among women in the U.S. There are approximately 20,000 new cases of ovarian cancer every year and approximately 70% are diagnosed in advanced Stage III/IV. Epithelial ovarian cancer is characterized by dissemination of tumors in the peritoneal cavity with a high risk of recurrence (75%, Stage III/IV) after surgery and chemotherapy. Since the five-year survival rates of patients with Stage III/IV disease at diagnosis are poor (41% and 20%, respectively), there remains a need for a therapy that not only reduces the recurrence rate, but also improves overall survival. The peritoneal cavity of advanced ovarian cancer patients contains the primary tumor environment and is an attractive target for a regional approach to immune modulation.

On May 8, 2025 Illumina, Inc. (Nasdaq: ILMN) ("Illumina" or the "company") reported its financial results for the first quarter of fiscal year 2025 (Press release, Illumina, MAY 8, 2025, View Source [SID1234652745]).

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"I’m proud that the Illumina team delivered strong Q1 revenue and EPS, a good start to the year in an increasingly dynamic business environment," said Jacob Thaysen, Chief Executive Officer. "Our outlook for the year has weakened due to shifting policy and geopolitical developments and we have taken swift incremental actions to protect our earnings. Our strategic focus remains on customer collaboration, driving differentiated innovations, and delivering on our long-term financial targets of growth and profitability."

First quarter Core Illumina segment results

GAAP Non-GAAP (a)
Dollars in millions, except per share amounts
Q1 2025 Q1 2024 Q1 2025 Q1 2024
Revenue (b) $ 1,041 $ 1,056 $ 1,041 $ 1,056
Gross margin (c) 65.6 % 65.7 % 67.4 % 67.1 %
Research and development (R&D) expense $ 252 $ 241 $ 241 $ 237
Selling, general and administrative (SG&A) expense $ 267 $ 336 $ 248 $ 254
Operating profit
$ 164 $ 116 $ 212 $ 218
Operating margin 15.8 % 11.0 % 20.4 % 20.6 %
Tax provision $ 51 $ 45 $ 44 $ 54
Tax rate 27.9 % 39.3 % 22.0 % 25.7 %
Net income $ 131 $ 70 $ 154 $ 155
Diluted EPS $ 0.82 $ 0.44 $ 0.97 $ 0.98

(a)See tables in "Results of Operations – Non-GAAP" section below for GAAP and non-GAAP reconciliations.
(b)Revenue for Q1 2024 included intercompany revenue of $7 million prior to the spin-off of GRAIL.
(c)Increase in gross margin was driven by execution of our operational excellence initiatives, that continue to deliver cost savings and improve productivity, and lower strategic partnership revenue that is lower margin, offset by lower product margins, primarily due to reduced pricing, and an increase in field service costs.

Capital expenditures for free cash flow purposes were $32 million for Q1 2025. Cash flow provided by operations was $240 million, compared to $284 million in the prior year period. Free cash flow (cash flow provided by operations less capital expenditures) was $208 million for the quarter, compared to $251 million in the prior year period. Depreciation and amortization expense was $69 million for Q1 2025. At the close of the quarter, the company held $1.24 billion in cash, cash equivalents and short-term investments.

Share repurchases for Q1 2025 were $200 million and the company intends to repurchase incremental shares over the course of the year as part of our ~$1.2 billion authorization remaining at the end of the quarter.

Key announcements since our last earnings release
•Instituted an incremental $100 million cost reduction program to mitigate the impact of a range of potential scenarios for a reduction in revenue and related operating income from the company’s Greater China business
•Unveiled first-of-its-kind spatial transcriptomics technology; Broad Institute to collaborate on flagship project
•Announced collaboration with Broad Clinical Labs to rapidly streamline and scale single-cell projects with cutting-edge tools and workflows
•Unveiled a series of roadmap innovations spanning genomics, spatial transcriptomics, single cell analysis, CRISPR technologies, epigenetics, and data analytics software
•Sequenced 250,000 whole genomes for the Alliance for Genomic Discovery (AGD) initiative
•Announced partnership with Tempus to accelerate clinical adoption of next-generation sequencing tests through novel evidence generation
•Dr. Scott Gottlieb elected as Board Chair, Keith Meister joined Board of Directors
•Named for the sixth year in a row to the Dow Jones Best-in-Class World Index and the Dow Jones Best-in-Class North America Index

A full list of recent announcements can be found in the company’s News Center.

Financial outlook and guidance
For fiscal year 2025, we expect:
◦Core Illumina revenue to decline between (1%) and (3%) on a constant currency basis year over year, down from low single digit growth previously
▪Revenue outside of the Greater China region expected to grow between 0% and 2% in 2025 on a constant currency basis year over year and includes our estimate reflecting changes in the research funding environment as well as the projected benefit from pricing actions
▪Reported revenue from the Greater China region expected to be $165 – $185 million in 2025 (with $72 million in revenue recognized in Q1 2025)
◦$85 million in tariff related costs which after actions is an approximate 125 bps reduction in fiscal year 2025 operating margin and $0.25 of EPS
◦Non-GAAP operating margin of approximately 21.5% – 22.0%, down from approximately 23% previously; and non-GAAP diluted EPS in the range of $4.20 – $4.30, a reduction from our March guidance of approximately $4.50, primarily due to the net impact of tariffs

The company provides forward-looking guidance on a non-GAAP basis, including on a constant currency basis for revenue and revenue growth rates. The company is unable to provide a reconciliation of forward-looking non-GAAP financial measures to the most directly comparable GAAP reported financial measures because it is unable to predict with reasonable certainty the impact of items such as acquisition-related expenses, fair value adjustments to contingent consideration, gains and losses from strategic investments, potential future asset impairments, restructuring activities, the ultimate outcome of pending litigation, and currency exchange rate fluctuations without unreasonable effort. These items are uncertain, inherently difficult to predict, depend on various factors, and could have a material impact on GAAP reported results for the guidance period. For the same reasons, the company is unable to address the significance of the unavailable information, which could be material to future results.

On May 8, 2025 Genmab reported interim results for the first Quarter ended March 31, 2025 (Press release, Genmab, MAY 8, 2025, View Source [SID1234652743]).

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Highlights

EPKINLY (epcoritamab) approved by the Japan Ministry of Health, Labour and Welfare (MHLW) for additional indication as a treatment for relapsed or refractory follicular lymphoma (FL)
Rinatabart sesutecan (Rina-S) continues to show encouraging antitumor activity in patients with advanced ovarian cancer in data presented at the 2025 Society of Gynecologic Oncology Annual Meeting on Women’s Cancer (SGO)
Tivdak (tisotumab vedotin) approved by the Japan MHLW and by the European Commission (EC) as the first and only antibody-drug conjugate (ADC) approved in both Japan and the European Union (EU) for the treatment of recurrent or metastatic cervical cancer after prior therapy
Genmab revenue increased 19% compared to the first quarter of 2024, to $715 million
"Our commitment to advancing our late-stage programs was reflected in the progress we made in the first quarter of the year. Both EPKINLY and Tivdak expanded their reach with approvals in additional territories and the updated Rina-S data presented at SGO reinforces its potential as a treatment option for patients with advanced ovarian cancer," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Financial Performance First Quarter of 2025

Revenue was $715 million for the first three months of 2025 compared to $603 million for the first three months of 2024. The increase of $112 million, or 19%, was primarily driven by higher DARZALEX and Kesimpta royalties achieved under our collaborations with Johnson & Johnson (J&J) and Novartis Pharma AG (Novartis), respectively, and EPKINLY net product sales.
Royalty revenue was $589 million in the first three months of 2025 compared to $452 million in the first three months of 2024, an increase of $137 million, or 30%. The increase in royalties was driven by higher net sales of DARZALEX and Kesimpta.
Net sales of DARZALEX (daratumumab), including sales of the subcutaneous (SC) product (daratumumab and hyaluronidase-fihj, sold under the tradename DARZALEX FASPRO in the U.S.) by J&J were $3,237 million in the first three months of 2025 compared to $2,692 million in the first three months of 2024, an increase of $545 million or 20%.
Total costs and operating expenses were $527 million in the first three months of 2025 compared to $487 million in the first three months of 2024. The increase of $40 million, or 8%, was driven by the expansion of our product pipeline, including Rina-S, the continued development of Genmab’s broader organizational capabilities as well as profit-sharing amounts payable to AbbVie Inc. (AbbVie) related to EPKINLY sales.
Operating profit was $188 million in the first three months of 2025 compared to $116 million in the first three months of 2024.
Net financial items resulted in income of $56 million for the first three months of 2025 compared to $133 million in the first three months of 2024. The decrease was primarily due to a decrease in foreign exchange impacts driven by the change in functional currency of Genmab A/S on January 1, 2025.

Outlook
Genmab is maintaining its 2025 financial guidance published on February 12, 2025.

Other Matters
Both the functional currency of the Genmab A/S legal entity and the presentation currency of the condensed consolidated financials statements have been changed from DKK to USD effective January 1, 2025. The change in functional currency has been implemented with prospective effect. The change in presentation currency has been implemented with retrospective effect. Comparative figures for prior periods have been restated accordingly.

Conference Call
Genmab will hold a conference call to discuss the results for the first quarter of 2025 today, Thursday, May 8, at 6:00 pm CEST, 5:00 pm BST or 12:00 pm EDT. To join the call please use the below registration link. Registered participants will receive an email with a link to access dial-in information as well as a unique personal PIN: https://register.vevent.com/register/BI2b36f53f97c64ad190f5eaa552875059. A live and archived webcast of the call and relevant slides will be available at View Source

On May 8, 2025 Delcath Systems, Inc. (Nasdaq: DCTH) ("Delcath" or the "Company"), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reported financial results and business highlights for the first quarter ended March 31, 2025 (Press release, Delcath Systems, MAY 8, 2025, View Source [SID1234652742]).

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First Quarter 2025 Financial Results

Total revenue of $19.8 million, compared with $3.1 million in the first quarter of 2024
HEPZATO KIT revenue of $18.0 million, compared to $2.0 million in the first quarter of 2024
CHEMOSAT revenue of $1.8 million, compared to $1.1 million in the first quarter of 2024
Gross margins of 86%, compared to 71% in the first quarter of 2024
Net income of $1.1 million, compared to a net loss of $11.1 million in the same quarter of 2024
Non-GAAP positive adjusted EBITDA in the first quarter of $7.6 million, compared to a loss of $7.3 million in the first quarter of 2024
Cash and investments of $58.9 million as of March 31, 2025
Cash provided by operations of $2.2 million in the quarter
Business Highlights and Updates

Activated three new U.S. centers in the first quarter and two more so far in the second quarter of 2025, bringing the current total to 19 active centers, with 10 additional centers accepting referrals
Received FDA clearance of an IND application for a phase 2 clinical trial of HEPZATO in liver-dominant metastatic breast cancer
Announced publication of comparative analysis from randomized portion of FOCUS Study in metastatic uveal melanoma
The exercise of 1.62 million Series F warrants resulted in $16.2 million of funding in 2025. The warrants were issued in 2020 as a component of a private placement and had an exercise price of $10.00 per share and expired on May 5, 2025
"Consistent revenue growth and the continued expansion of active treatment centers represent a strong start to 2025," said Gerard Michel, Chief Executive Officer of Delcath. "We achieved our first quarter of net income and positive operating cash flow, underscoring the accelerating clinical adoption of HEPZATO for patients with metastatic uveal melanoma. Ongoing dialogue with oncologists and interventional radiologists reinforces the importance of whole-liver treatment for patients with liver-dominant disease. These insights continue to shape our development strategy as we pursue additional indications for HEPZATO."

First Quarter 2025 Results

Total revenue for the quarter ending March 31, 2025 was $19.8 million compared to $3.1 million for the same period in the prior year. Revenue in the quarter includes sales of $18.0 million of HEPZATO in the U.S. and $1.8 million of CHEMOSAT in Europe.

Research and development expenses for the quarter ended March 31, 2025, were $5.0 million compared to $3.7 million for the same period in the prior year. The increase is primarily due to costs associated with expanding the clinical team and initiation of the Phase 2 clinical trial evaluating HEPZATO in combination with standard of care for mCRC. In 2024, these costs primarily related to medical affairs and regulatory costs associated with the approved products.

Selling, general and administrative expenses for the quarter ending March 31, 2025, were $11.3 million compared to $8.8 million for the same period in the prior year. The increase is primarily due to continued commercial expansion activities including marketing-related expenses and additional personnel in the commercial team.

Net income for the quarter ended March 31, 2025 was $1.1 million compared to net loss of $11.1 million for the same period in the prior year.

Non-GAAP adjusted EBITDA for the quarter ended March 31, 2025 was $7.6 million compared to adjusted EBITDA loss of $7.3 million for the same period in the prior year. A table reconciling non-GAAP measures is included in this press release for reference.

As of March 31, 2025, the Company had $58.9 million in cash and investments, and no debt.

Conference Call Information
To participate in this event, dial in approximately 5 to 10 minutes before the beginning of the call.

Event Date: Thursday, May 8, 2025
Time: 8:30 AM Eastern Time

Participant Numbers:
Toll Free: 1-877-407-3982
International: 1-201-493-6780
Webcast: View Source;tp_key=6de250d858
A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company’s website View Source

On May 8, 2025 Cullinan Therapeutics, Inc. (Nasdaq: CGEM; "Cullinan"), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, reported recent and anticipated business highlights and announced its financial results for the first quarter ended March 31, 2025 (Press release, Cullinan Oncology, MAY 8, 2025, View Source [SID1234652741]).

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"As a leader in T cell engager development for autoimmune diseases, we continue to rapidly advance our global clinical development of CLN-978 in several autoimmune diseases and across multiple geographies. With an extensive global network of clinical investigators, CLN-978 is now in active clinical development in systemic lupus erythematosus (SLE), rheumatoid arthritis and Sjögren’s disease and we expect to deliver initial clinical data in SLE by the end of the year," said Nadim Ahmed, Chief Executive Officer of Cullinan Therapeutics.

"In parallel, we continue to advance and refine our oncology programs. We recently announced that the pivotal Phase 2b portion of the REZILIENT1 study of zipalertinib met the primary endpoint of overall response rate. Together with our partner Taiho, we will share the results in an oral presentation at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting. For CLN-619, our MICA/B antibody, we are narrowing the scope of the program, which will allow for reallocation of resources. With $567.4 million in cash and investments and runway into 2028, we have the resources required to maintain our leadership position in autoimmune diseases and deliver meaningful value-driving catalysts across both our immunology and oncology programs."

Portfolio Highlights

Immunology

•
CLN-978 (CD19xCD3 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 ongoing in the United States, Europe, and Australia, and the Company plans to share initial clinical data in Q4 2025.
o
In April 2025, the Company received approval from EMA to initiate a Phase 1 study in patients with active, difficult-to-treat rheumatoid arthritis. The Company expects to initiate the study at FAU Erlangen-Nuremberg in Germany and Università Cattolica del Sacro Cuore in Italy in Q2 2025.
o
In April 2025, the Company announced plans to initiate a Phase 1 study in patients with active, moderate to severe Sjögren’s disease in the U.S. in Q2 2025.
Oncology

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CLN-619 (Anti-MICA/MICB monoclonal antibody): NSCLC and multiple myeloma
o
Following a review of the data from the disease-specific expansion cohorts for endometrial and cervical cancers, the Company has discontinued further development of CLN-619 in patients with gynecological cancers as preliminary results did not meet the internal threshold for advancement.
o
Cullinan will continue enrolling to go/no-go decisions the ongoing expansion cohorts in patients with NSCLC and the ongoing Phase 1 study in patients with relapsed/refractory multiple myeloma.
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Zipalertinib (EGFR ex20ins inhibitor), collaboration with Taiho Oncology: EGFR ex20ins NSCLC
o
In January 2025, Cullinan announced that the pivotal Phase 2b portion of REZILIENT1 met the primary endpoint of overall response rate in patients with EGFR ex20ins NSCLC who have received prior therapy. The results will be presented during an oral abstract session at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting on June 1, 2025.
o
Pending discussions with the U.S. Food and Drug Administration, Taiho plans to submit an NDA in relapsed/refractory EGFR ex20ins NSCLC in the second half of 2025. Taiho continues enrollment of the pivotal study REZILIENT3 in 1L EGFR ex20ins NSCLC.

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CLN-049 (FLT3xCD3 T cell-engaging bispecific antibody): Acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)
o
Enrollment continues in the ongoing Phase 1 study in patients with relapsed/refractory AML or MDS, and in the ongoing Phase 1 study in patients with measurable minimal residual disease in AML.
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CLN-617 (IL-2 and IL-12 cytokine fusion protein): Solid tumors
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Enrollment continues in the ongoing Phase 1 study in patients with advanced solid tumors.
First Quarter 2025 Financial Results

•
Cash Position: Cash, cash equivalents, short- and long-term investments, and interest receivable were $567.4 million as of March 31, 2025. Cullinan continues to expect its cash resources to provide runway into 2028 based on its current operating plan.
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R&D Expenses: Research and development expenses were $41.5 million for the first quarter of 2025, compared to $30.6 million for the same period in 2024.
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G&A Expenses: General and administrative expenses were $13.5 million for the first quarter of 2025, compared to $12.3 million for the same period in 2024.
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Net Loss: Net loss attributable to Cullinan was $48.5 million for the first quarter of 2025, compared to $37.1 million for the same period in 2024.