Cullinan (CGEM) Q2 R&D Jumps 68%

Key Points

• Cullinan Therapeutics (NASDAQ:CGEM) increased research and development expenses by 68.0% in Q2 2025 compared to the same period in 2024, reflecting pipeline expansion and clinical progress.

• Net loss (GAAP) was $70.1 million, with loss per share (GAAP) of ($1.07), worse than the consensus estimate of ($0.83).

• No revenue was reported, with the company maintaining a cash runway projected into 2028 and multiple regulatory milestones ahead.

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Cullinan Therapeutics (NASDAQ:CGEM), a clinical-stage biopharmaceutical company focused on developing therapies for cancer and autoimmune diseases, released its second quarter 2025 earnings on August 7, 2025. The period was marked by higher spending as it advanced its clinical trials and expanded the pipeline, particularly with the new velinotamig autoimmune candidate. Cullinan reported a net loss of $70.1 million, or ($1.07) per share (GAAP).—$0.24 higher than the estimated loss per share of ($0.83). No revenue was reported. Overall, the quarter showed heavy investment in research, increased operating expenses, and a continued pipeline focus, but also highlighted growing losses as Cullinan awaits future clinical and regulatory milestones.

Source: Analyst estimates for the quarter provided by FactSet.

About Cullinan Therapeutics and Its Current Focus

Cullinan Therapeutics develops new treatments for immune-system disorders and cancer. It operates as a clinical-stage company, which means its products are not yet approved for sale and generate no commercial revenue.

The business centers on pipeline advancement, with key drug candidates targeting both autoimmune diseases and various cancers. Success depends on progressing these therapies through clinical trials, establishing partnerships, and securing regulatory approvals for future marketing.

Quarterly Highlights and Key Developments

The quarter was defined by a major increase in research and development (R&D) spending, which reached $61.0 million, up 68.1% from the same period last year. This surge reflects Cullinan's push into more clinical trials and the acquisition of new drug candidates. In June 2025, Cullinan signed a license agreement with Genrix Bio for velinotamig, a bispecific T cell engager targeting BCMA (B cell maturation antigen) and CD3 proteins, with a $20 million upfront payment and additional milestones that may reach $692 million if successful. These developments align with Cullinan’s strategy to broaden its reach in autoimmune therapies and reinforce its commitment to advancing new product classes.

Ongoing clinical programs in oncology also made advances. Zipalertinib, a targeted drug for a rare mutation in non-small cell lung cancer (NSCLC), is progressing toward a new drug application (NDA) submission with the U.S. Food and Drug Administration by the end of 2025. This is being developed with Taiho Oncology, Cullinan’s strategic partner, and represents Cullinan's most advanced project with potential commercialization on the horizon.

Other immunology drugs such as CLN-978, a bispecific T cell engager designed for diseases like systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and Sjögren’s disease, are now enrolling patients in Phase 1 studies. Initial safety and biological data for CLN-978 in SLE are expected in Q4 2025. Early data from the RA program are planned for the first half of 2026—timelines that the company has publicly reinforced.

Financial results show not only increased R&D outlays, but also a modest rise in general and administrative expenses, which climbed to $14.8 million, up from $13.8 million a year earlier (GAAP). Although the company booked no revenue, it ended the period with $510.9 million in cash and equivalents, which it projects will last into 2028. No dividends were declared as Cullinan does not currently pay a dividend.

Looking Ahead: Guidance and Considerations

Cullinan's management projects its current cash resources will support operations into 2028 under its current operating plan, even as spending increases to fund portfolio acquisitions. The next year is set to feature several anticipated milestones, including key clinical data for both the autoimmune and oncology portfolios and a possible FDA submission for zipalertinib. These events will heavily influence Cullinan’s future prospects, as any regulatory or trial outcomes could impact funding needs and market positioning.

No specific revenue or profit guidance was provided for the quarters ahead. For investors, the main factors to watch will be progress in ongoing clinical trials—especially data readouts for lead programs like CLN-978 and zipalertinib—regulatory decision timelines, and the pace of cash burn versus clinical advancement. CGEM does not currently pay a dividend.

Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted.

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JesterAI is a Foolish AI, based on a variety of Large Language Models (LLMs) and proprietary Motley Fool systems. All articles published by JesterAI are reviewed by our editorial team, and The Motley Fool takes ultimate responsibility for the content of this article. JesterAI cannot own stocks and so it has no positions in any stocks mentioned. The Motley Fool recommends Cullinan Therapeutics. The Motley Fool has a disclosure policy.