Cullinan Therapeutics Provides Corporate Update and Reports Fourth Quarter and Full Year 2025 Financial Results

Rhea-AI Summary

Cullinan Therapeutics (Nasdaq: CGEM) reported Q4 and full-year 2025 results and a detailed 2026 clinical and regulatory roadmap. Cash, cash equivalents, investments and interest receivable totaled $439.0 million as of December 31, 2025, providing runway into 2029 under current plans.

Key near-term catalysts: initial CLN-978 data in SLE and RA in Q2 2026, repeat-dosing RA data in Q3 2026, zipalertinib rolling 2L NDA submission completed and REZILIENT3 enrollment finished with top-line by year-end 2026, and CLN-049 advancement toward registrational AML development.

Positive

• Cash and investments of $439.0M as of 12/31/2025, runway into 2029
• CLN-978 initial data in SLE and RA expected Q2 2026, creating near-term clinical catalysts
• Zipalertinib 2L rolling NDA submission completed; REZILIENT3 enrollment finished with top-line by year-end 2026
• CLN-049 has U.S. FDA Fast Track designation and plans for registrational development in AML

Negative

• Full-year R&D expense rose to $187.4M from $142.9M (2024), a >30% increase
• Full-year net loss increased to $219.9M from $167.4M (2024), a >30% rise

News Market Reaction – CGEM

-2.61%

3 alerts

-2.61% News Effect

+4.9% Peak Tracked

-$24M Valuation Impact

$904M Market Cap

0.0x Rel. Volume

On the day this news was published, CGEM declined 2.61%, reflecting a moderate negative market reaction. Argus tracked a peak move of +4.9% during that session. Our momentum scanner triggered 3 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $24M from the company's valuation, bringing the market cap to $904M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Cash & investments: $439.0 million Cash runway: Into 2029 R&D expenses Q4 2025: $42.9 million +5 more

8 metrics

Cash & investments $439.0 million As of December 31, 2025; company-guided runway into 2029

Cash runway Into 2029 Based on current operating plan and $439.0M cash position

R&D expenses Q4 2025 $42.9 million Quarter vs $40.5M in Q4 2024

R&D expenses FY 2025 $187.4 million Full year vs $142.9M in 2024

G&A expenses Q4 2025 $12.3 million Quarter vs $14.6M in Q4 2024

Net loss FY 2025 $219.9 million Full year vs $167.4M in 2024

Regulatory milestone 2L $30 million Eligibility upon U.S. 2L regulatory approval of zipalertinib

Regulatory milestone 1L Up to $100 million Eligibility upon U.S. 1L regulatory approval of zipalertinib

Market Reality Check

Price: $14.91 Vol: Volume 861,289 is slightl...

normal vol

$14.91 Last Close

Volume Volume 861,289 is slightly above 20-day average 848,234, indicating typical trading interest into earnings. normal

Technical Shares at $15.31 are trading above the 200-day MA of $9.18 and 8.54% below the 52-week high.

Peers on Argus

CGEM traded down 2.73% while key peers were mixed: AUTL up 7.28%, INBX up 3.87%,...

1 Up 1 Down

CGEM traded down 2.73% while key peers were mixed: AUTL up 7.28%, INBX up 3.87%, LXRX down 0.59%, others flat. This pattern points to a company-specific reaction rather than a broad biotech move.

Previous Earnings Reports

5 past events · Latest: Nov 06 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Nov 06	Q3 2025 earnings	Positive	+0.6%	Reported Q3 2025 results, strong cash of $475.5M and pipeline milestones.
Aug 07	Q2 2025 earnings	Negative	-10.8%	Q2 2025 results showed higher R&D and net loss despite solid cash.
May 08	Q1 2025 earnings	Positive	+0.9%	Q1 2025 results with $567.4M cash, EMA nod and positive NSCLC data.
Feb 27	FY 2024 earnings	Positive	+1.9%	Q4/FY 2024 results, $606.9M cash and pivotal zipalertinib progress.
Nov 07	Q3 2024 earnings	Positive	-5.5%	Q3 2024 update with $639.0M cash and advancing CLN‑978 and zipalertinib.

Pattern Detected

Earnings updates have historically produced mixed reactions, with an average move of about -2.58%, skewing slightly negative despite generally constructive pipeline and cash updates.

Recent Company History

Across the last five earnings releases from Nov 2024 through Nov 2025, Cullinan repeatedly highlighted strong cash positions (from $639.0M down to $475.5M) and progress for CLN‑978, CLN‑049 and zipalertinib. Stock reactions have been split, with three modestly positive moves and two notable selloffs, yielding an average move of -2.58%. Today’s full-year 2025 update continues the pattern of emphasizing runway into 2029 and advancing T cell engager programs.

Historical Comparison

-2.6% avg move · In the past five earnings-style updates, CGEM moved on average -2.58%. Today’s -2.73% pre-news decli...

earnings

-2.6%

Average Historical Move earnings

In the past five earnings-style updates, CGEM moved on average -2.58%. Today’s -2.73% pre-news decline is broadly consistent with its typical, slightly negative reaction pattern around financial results.

Earnings releases show a steady transition from earlier CLN‑978 clearances into multi-indication trials and stronger CLN‑049 and zipalertinib data, while cash balances declined from $639.0M to $475.5M before today’s reported $439.0M.

Market Pulse Summary

This announcement combines full-year 2025 financials with a dense roadmap of 2026 catalysts, includi...

Analysis

This announcement combines full-year 2025 financials with a dense roadmap of 2026 catalysts, including multiple CLN‑978 data readouts, CLN‑049 expansion and pivotal planning, and a completed rolling NDA plus pivotal enrollment for zipalertinib. With $439.0M in cash and runway into 2029, the focus falls on execution: meeting disclosed data timelines, controlling rising R&D and net losses, and converting the Taiho partnership milestones into actual payments.

Key Terms

rolling nda submission, nda, phase 1/2 combination study, fast track designation, +4 more

8 terms

rolling nda submission regulatory

"Zipalertinib rolling NDA submission completed; enrollment of REZILIENT3..."

A rolling NDA submission is a regulatory filing process where a drug developer sends portions of a new drug application to the health authority as each section is completed, instead of waiting to file the entire dossier all at once. For investors this can speed up the review timeline and reduce the time it takes for a potential approval to reach the market, similar to handing in chapters of a book early so an editor can start reviewing while you finish the rest.

nda regulatory

"In February, Taiho completed the rolling NDA submission to the U.S. FDA..."

An NDA, or nondisclosure agreement, is a legal contract that keeps certain information private between parties. It’s like a promise not to share sensitive details, helping protect business ideas, strategies, or data from being leaked or used without permission. For investors, NDAs help ensure that confidential information remains secure, enabling trust and open communication during business discussions.

phase 1/2 combination study medical

"In Q4 2026, the Company plans to initiate a Phase 1/2 combination study..."

A phase 1/2 combination study is an early-stage clinical trial that merges initial safety and dose-finding work (phase 1) with a preliminary look at whether the combined treatments show signs of benefit (phase 2), all in one trial. For investors, these studies can speed development and reduce costs by testing safety and early effectiveness together, but they carry higher scientific and regulatory risk because decisions are made from smaller, earlier data — like a chef both perfecting a recipe and polling customers at the same time.

fast track designation regulatory

"after sharing compelling clinical data at ASH 2025 and with U.S. FDA Fast Track Designation..."

A "fast track designation" is a process that speeds up the review and approval of a product or project, allowing it to reach the market or be completed more quickly than usual. For investors, it can signal that a product may become available sooner, potentially leading to earlier revenue or benefits, and indicating a priority status that might influence company performance and market opportunities.

measurable residual disease medical

"Enrollment also continues in a parallel Phase 1 study in patients with AML and measurable residual disease (MRD)..."

Measurable residual disease (MRD) is the tiny number of cancer cells that remain in a patient after treatment and can be detected using sensitive laboratory tests even when scans look clear. For investors, MRD matters because it's a strong early signal of how well a therapy works, can influence clinical trial success, regulatory decisions and future sales, and helps predict whether disease will come back much like spotting embers after a put-out fire.

egfr ex20ins medical

"Zipalertinib (EGFR ex20ins inhibitor), collaboration with Taiho Oncology..."

A group of specific changes in the EGFR gene called exon 20 insertions are mutations that alter a protein on cancer cells’ surfaces, letting tumors grow and making many standard EGFR-targeting drugs less effective. For investors, these mutations matter because they define a patient subgroup with unmet medical need and a clear market for new, specialized treatments—think of a lock that no longer works with the usual key, creating demand for a new key.

cd19xcd3 bispecific t cell engager medical

"CLN-978 (CD19xCD3 bispecific T cell engager): Systemic Lupus Erythematosus..."

A CD19×CD3 bispecific T‑cell engager is a lab-made antibody that acts like a matchmaker between a patient’s T cells (immune soldiers) and B cells that carry the CD19 marker, forcing T cells to recognize and kill those B cells. For investors, these drugs can be high-impact cancer therapies with the potential for rapid revenue if clinical trials and approvals succeed, but they also carry regulatory, safety and manufacturing risks that can sharply sway a company’s value.

bcmaxcd3 bispecific t cell engager medical

"Velinotamig (BCMAxCD3 bispecific T cell engager): Autoimmune diseases..."

A bcmaxcd3 bispecific T cell engager is a lab-made protein that acts like a matchmaker between a cancer cell marker called BCMA and a T cell surface protein called CD3, bringing a patient’s killer immune cells into close contact with tumor cells so they can be destroyed. Investors pay attention because these therapies can produce dramatic treatment responses or safety issues in clinical trials, and trial results, manufacturing success, or regulatory decisions can strongly move a company’s valuation.

AI-generated analysis. Not financial advice.

Initial clinical data for CLN-978 in SLE and RA confirmed for Q2 2026; repeat dosing data in RA confirmed for Q3 2026

Zipalertinib rolling NDA submission completed; enrollment of REZILIENT3 frontline study completed with top-line results available by year-end 2026

Cash and investments of $439.0 million as of December 31, 2025; runway into 2029

CAMBRIDGE, Mass., March 10, 2026 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM; “Cullinan”), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, high-impact therapies in autoimmune diseases and cancer, today provided an update on recent and anticipated business highlights and announced its financial results for the fourth quarter and full year ended December 31, 2025.

“Cullinan Therapeutics is poised to deliver multiple value-driving catalysts across our programs throughout 2026. Strong enrollment momentum for CLN-978 positions us to deliver the first company-sponsored data for a potential best-in-class CD19 T cell engager in autoimmune diseases in the second quarter, followed by important additional data updates throughout the year. CLN-978 is the ideal therapy for immune reset, with the optimal combination of target, CD19, and modality, T cell engager, together with the convenience of subcutaneous administration. This program has the potential to transform the treatment landscape in autoimmune diseases and deliver a compelling commercial opportunity,” said Nadim Ahmed, President and CEO of Cullinan Therapeutics.

“We are also pleased to begin the year with strong momentum in our oncology portfolio. With our partner, Taiho, we have completed the second line rolling NDA submission for zipalertinib and have fully enrolled the frontline study, REZILIENT3, both important milestones as zipalertinib moves closer to being available for patients. Finally, after sharing compelling clinical data at ASH 2025 and with U.S. FDA Fast Track Designation, we expect to rapidly advance CLN-049 to registrational development in AML.”

Portfolio Highlights and 2026 Milestones

Immunology

• CLN-978 (CD19xCD3 bispecific T cell engager): Systemic Lupus Erythematosus (SLE), Rheumatoid arthritis (RA), and Sjögren’s disease (SjD)
• OUTRACE SLE
  • In Q2 2026, the Company plans to share initial data from Part A (single target dose escalation) with a focus on safety and B cell depletion in peripheral blood, as well as other biomarker data and preliminary clinical activity data.
• OUTRACE RA
  • In Q2 2026, the Company plans to share initial data from the single target dose escalation portion of the study with a focus on safety and B cell depletion in peripheral blood and tissue, as well as other biomarker data and preliminary clinical activity data.
  • In Q3 2026, the Company plans to share initial repeat dosing data, including B cell depletion in peripheral blood and tissue, as well as other biomarker data and preliminary clinical activity data.
• OUTRACE SjD
  • In Q4 2026, the Company plans to share initial data from Part A (single target dose escalation) with a focus on safety and B cell depletion in peripheral blood and tissue, as well as other biomarker data and preliminary clinical activity data.
• Velinotamig (BCMAxCD3 bispecific T cell engager): Autoimmune diseases
  • Genrix Bio is enrolling a Phase 1 study in China in patients with autoimmune diseases, initially in patients with SLE, followed by future planned expansion into other indications and initial clinical data from the study are expected to be shared in Q4 2026. Cullinan intends to use the data generated to accelerate global clinical development. Following completion of the Genrix Bio Phase 1 study, Cullinan will conduct all further development of velinotamig in autoimmune diseases.
    
    

Oncology

• CLN-049 (FLT3xCD3 bispecific T cell engager): Acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)
  • The Company plans to share an update from the dose escalation portion of the Phase 1 study in patients with relapsed/refractory AML or MDS in H2 2026.
  • In Q2 2026, the Company expects to initiate monotherapy dose expansion cohorts in patients with relapsed/refractory AML and TP53m AML. In Q4 2026, the Company expects to complete enrollment for dose expansion to determine the recommended Phase 2 dose (RP2D) for an expected single arm pivotal registrational trial.
  • In Q4 2026, the Company plans to initiate a Phase 1/2 combination study in frontline AML.
  • Enrollment also continues in a parallel Phase 1 study in patients with AML and measurable residual disease (MRD) immediately following induction therapy.
    
    
• Zipalertinib (EGFR ex20ins inhibitor), collaboration with Taiho Oncology: EGFR ex20ins NSCLC
  
  • In February, Taiho completed the rolling NDA submission to the U.S. FDA seeking accelerated approval of zipalertinib for the treatment of patients with locally advanced or metastatic EGFR ex20ins NSCLC who have previously received platinum-based systemic chemotherapy.
  • In February, Taiho completed enrollment of the pivotal study REZILIENT3 in 1L EGFR ex20ins NSCLC. Taiho expects to obtain top-line results by the end of 2026.
  • Cullinan is eligible to receive $30 million and up to $100 million upon 2L and 1L U.S. regulatory approvals, respectively, and a 50/50 profit share in the U.S. moving forward.
    
    

Fourth Quarter and Full Year 2025 Financial Results

• Cash Position: Cash, cash equivalents, short- and long-term investments, and interest receivable were $439.0 million as of December 31, 2025. Cullinan expects its cash resources to provide runway into 2029 under its current operating plan.
• R&D Expenses: Research and development expenses were $42.9 million for the fourth quarter of 2025, compared to $40.5 million for the same period in 2024, and $187.4 million for the full year 2025, compared to $142.9 million for the full year 2024.
• G&A Expenses: General and administrative expenses were $12.3 million for the fourth quarter of 2025, compared to $14.6 million for the same period in 2024, and $54.2 million for the full year 2025, compared to $54.0 million for the full year 2024.
• Net Loss: Net loss attributable to Cullinan was $50.7 million for the fourth quarter of 2025, compared to $47.6 million for the same period in 2024, and $219.9 million for the full year 2025, compared to $167.4 million for the full year 2024.
  
  

About Cullinan Therapeutics

Cullinan Therapeutics, Inc. (Nasdaq: CGEM) is a biopharmaceutical company developing potential first- or best-in-class, high-impact therapies for autoimmune diseases and cancer. Cullinan pursues promising therapeutic targets while leveraging core expertise in T cell engagers, which are established in oncology and are now advancing into autoimmune diseases. With a clinical-stage pipeline built on a rigorous scientific approach and purposeful innovation, Cullinan is advancing its mission to deliver new standards of care for patients. Learn more about Cullinan at https://cullinantherapeutics.com/, and follow Cullinan on LinkedIn and X.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements regarding the company’s beliefs and expectations regarding: our preclinical and clinical developments plans and timelines for our product candidates, the clinical and therapeutic potential of our product candidates, the strategy of our product candidates, our research and development activities, our cash runway, and other statements that are not historical facts. The words “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “plan,” “potential,” “project,” “pursue,” “will,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

Any forward-looking statements in this press release are based on management's current expectations and beliefs of future events and are subject to known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks include, but are not limited to, the following: uncertainty regarding the timing and results of regulatory submissions; the risk that any INDs, NDAs or other global regulatory submissions we may file with the United States Food and Drug Administration or other global regulatory agencies are not cleared or approved on our expected timelines, or at all; the success of our clinical trials and preclinical studies; the risks related to our ability to protect and maintain our intellectual property position; the risks related to manufacturing, supply, and distribution of our product candidates; the risk that any one or more of our product candidates, including those that are co-developed, will not be successfully developed and commercialized; the risk that the results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies; the effect of changes in global economic conditions, including uncertainties related to international trade policies, tariffs and supply chain dynamics on our business and operations; and the success of any collaboration, partnership, license or similar agreements. These and other important risks and uncertainties discussed in our filings with the Securities and Exchange Commission, including under the caption “Risk Factors” in our most recent Annual Report on Form 10-K and subsequent filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change, except to the extent required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Moreover, except as required by law, neither the company nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made.

Cullinan Therapeutics, Inc. Selected Condensed Consolidated Balance Sheet Data (unaudited) (in thousands)
		December 31, 2025				December 31, 2024
Cash, cash equivalents, investments, and interest receivable		$	438,960			$	606,917
Total assets		$	448,374			$	621,824
Total current liabilities		$	37,741			$	30,647
Total liabilities		$	39,644			$	31,496
Total stockholders’ equity		$	408,730			$	590,328

Cullinan Therapeutics, Inc. Consolidated Statements of Operations (unaudited) (in thousands, except per share amounts)
		Three Months Ended								Twelve Months Ended
		December 31, 2025				December 31, 2024				December 31, 2025				December 31, 2024
Operating expenses:
Research and development		$	42,945			$	40,492			$	187,402			$	142,903
General and administrative			12,314				14,556				54,246				54,016
Total operating expenses			55,259				55,048				241,648				196,919
Loss from operations			(55,259	)			(55,048	)			(241,648	)			(196,919	)
Other income (expense):
Interest income			4,615				7,512				22,212				29,660
Other income (expense), net			(69	)			6				(443	)			(199	)
Net loss before income taxes			(50,713	)			(47,530	)			(219,879	)			(167,458	)
Income tax expense (benefit)			—				117				—				117
Net loss			(50,713	)			(47,647	)			(219,879	)			(167,575	)
Net loss attributable to noncontrolling interests			—				—				—				(192	)
Net loss attributable to Cullinan		$	(50,713	)		$	(47,647	)		$	(219,879	)		$	(167,383	)
Basic and diluted net loss per share attributable to Cullinan:
Common stock		$	(0.77	)		$	(0.73	)		$	(3.36	)		$	(2.78	)
Preferred stock		$	(7.73	)		$	(7.32	)		$	(33.57	)		$	(27.78	)
Weighted-average shares used in computing basic and diluted net loss per share attributable to Cullinan:
Common stock			59,201				58,580				59,050				53,771
Preferred stock			640				648				645				648

Contacts:

Investors
Nick Smith
+1 401.241.3516
nsmith@cullinantx.com

Media 
Rose Weldon
+1 215.801.7644
rweldon@cullinantx.com

FAQ

When will Cullinan Therapeutics (CGEM) report initial CLN-978 data for SLE and RA?

Initial CLN-978 single-dose data for SLE and RA are expected in Q2 2026. According to the company, those updates will focus on safety, peripheral B cell depletion, biomarkers and preliminary clinical activity, with repeat-dosing RA data expected in Q3 2026.

What is the cash runway for Cullinan Therapeutics (CGEM) as of December 31, 2025?

Cullinan had $439.0 million in cash, equivalents, investments and interest receivable as of 12/31/2025. According to the company, that cash position is expected to fund operations into 2029 under its current operating plan.

What is the status of zipalertinib and the REZILIENT3 trial for CGEM's partner Taiho?

Taiho completed a 2L rolling NDA submission for zipalertinib and fully enrolled REZILIENT3 in 1L EGFR ex20ins NSCLC. According to the company, Taiho expects top-line REZILIENT3 results by the end of 2026 and regulatory milestones could trigger up to $130 million to Cullinan.

How did Cullinan Therapeutics' 2025 R&D and net loss compare to 2024?

Full-year R&D expense rose to $187.4 million in 2025 from $142.9 million in 2024, and net loss increased to $219.9 million from $167.4 million. According to the company, rising development activity drove the year-over-year increases.

What near-term development milestones should investors watch for Cullinan (CGEM) in 2026?

Investors should watch CLN-978 initial data in Q2 2026, repeat-dosing RA data in Q3 2026, zipalertinib regulatory/readout milestones through 2026, and CLN-049 dose-expansion and registrational planning in H2–Q4 2026. According to the company, these are the primary 2026 catalysts.