Cullinan Therapeutics Provides Corporate Update and Reports Third Quarter 2026 Financial Results

Lower research and administrative spending accompanied a narrower quarterly loss, while cash resources are expected to last into 2029.

Rhea-AI Summary

Cullinan Therapeutics (CGEM) reported a third-quarter net loss of $49.388 million and outlined advances across its autoimmune disease and cancer pipeline. The loss narrowed from $50.610 million a year earlier. Cash, investments and interest receivable totaled $313.813 million at September 30, 2026; the company expects funding to last into 2029.

CLN-978 autoimmune disease data are planned for December. Cullinan initiated a global Phase 1/2 velinotamig study and a potentially registrational Phase 2 CLN-049 leukemia study. Taiho began submitting zipalertinib plus chemotherapy for first-line lung cancer approval, with completion expected in November. A separate zipalertinib monotherapy application remains under review, with a February 27, 2027 FDA target action date. Cullinan is eligible for $30 million and $100 million upon respective second- and first-line U.S. approvals, plus a 50/50 U.S. profit share.

21 points · 1 major

PositiveiHow this balance works

How this balance works

Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.

It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.

Rhea-AI Sentiment measures something else, the tone of the wording.

How the balance worksHow Sentiment works

0 major · 8 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Major pointZipalertinib Phase 3 REZILIENT3 met its primary endpoint, improving progression-free survival versus chemotherapy at interim analysis.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Zipalertinib eligibility includes $30 million for second-line approval, $100 million for first-line approval and 50/50 U.S. profit sharing.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Zipalertinib first-line combination application submission began in October; completion is expected in November.
• Moderate pointCLN-049 potentially registrational Phase 2 study began in October for relapsed/refractory acute myeloid leukemia.
• Moderate point. Forward-looking: it has not happened yet and may not happen.Cash resources are expected to provide runway into 2029 under Cullinan's current operating plan.

16 minor points

• Minor pointZipalertinib REZILIENT2 Cohort C data showed intracranial antitumor activity in patients with active brain metastases.
• Minor pointCLN-049 combination study with venetoclax and azacitidine began in November for newly diagnosed acute myeloid leukemia.
• Minor pointVelinotamig global Phase 1/2 study initiated following U.S. and Australian clearances for autoimmune blood disorders.
• Minor pointVelinotamig China study showed proteinuria reductions in 5 of 7 eligible lupus patients; four achieved complete renal responses.
• Minor pointVelinotamig China study reported a favorable safety profile.
• Minor point. Forward-looking: it has not happened yet and may not happen.CLN-978 update planned for December includes multi-dose data from approximately 20 patients across three autoimmune diseases.
• Minor point. Forward-looking: it has not happened yet and may not happen.CLN-049 updated Phase 1 dose-escalation results are scheduled for presentation on December 13, 2026.
• Minor pointThird-quarter research spending fell to $40.169 million from $41.968 million a year earlier.
• Minor pointThird-quarter administrative spending fell to $12.431 million from $13.627 million a year earlier.
• Minor pointThird-quarter net loss narrowed to $49.388 million from $50.610 million a year earlier.
• Minor pointThird-quarter common loss per share narrowed to $0.74 from $0.77; preferred loss narrowed to $7.43 from $7.72.
• Minor pointNine-month research spending fell to $126.729 million from $144.457 million in the comparable 2025 period.
• Minor pointNine-month administrative spending fell to $36.822 million from $41.932 million in the comparable 2025 period.
• Minor pointNine-month net loss narrowed to $152.753 million from $169.166 million in the comparable 2025 period.
• Minor pointNine-month common loss per share narrowed to $2.31 from $2.58; preferred loss narrowed to $23.06 from $25.84.
• Minor pointOther expense fell to $76,000 quarterly and $236,000 year-to-date, versus $108,000 and $374,000 in comparable 2025 periods.

Negative

• Moderate pointCash, investments and interest receivable fell to $313.813 million from $438.960 million at December 31, 2025.
• Minor pointZipalertinib monotherapy approval remains pending FDA review, with a February 27, 2027 target action date.
• Minor point. Forward-looking: it has not happened yet and may not happen.CLN-049 Phase 2 requires dose optimization before expansion at the recommended Phase 2 dose.
• Minor pointStockholders' equity fell to $281.284 million from $408.730 million at December 31, 2025.
• Minor pointTotal assets fell to $322.559 million from $448.374 million at December 31, 2025.

3 minor points

• Minor pointTotal liabilities increased to $41.275 million from $39.644 million at December 31, 2025.
• Minor pointThird-quarter interest income declined to $3.288 million from $5.093 million a year earlier.
• Minor pointNine-month interest income declined to $11.034 million from $17.597 million in the comparable 2025 period.

News Explained

The update broadens AML testing and adds an early renal-response signal from a selected SLE subgroup.

Cullinan initiated a Phase 1/2 study combining CLN-049, venetoclax and azacitidine in newly diagnosed AML, adding a combination study alongside its relapsed/refractory AML program.

At ACR Convergence, the company shared Genrix Bio Phase 1/2 data from China: among 7 patients with SLE and elevated baseline proteinuria, 5 had rapid, marked reductions and 4 achieved a complete renal response.

Argus 15 min delay 13 alerts

-2.90% vs previous close $11.39 last price 1.2x rel. volume Open Argus

Details

Market Reaction – CGEM

$10.95 – $12.42 Day Range

$733.00M Mkt Cap at Last Price

On Nov 10, the day this news came out, the latest delayed price for CGEM is 2.90% below the previous close. Our momentum scanner has recorded 13 alerts for this stock so far that day. The latest delayed price is $11.39.

Data tracked by StockTitan Argus (15 min delayed). Upgrade to Gold for real-time data.

Key Figures

Cash and investments: $313.8 million Cash runway: Into 2029 Proteinuria reductions: 5 of 7 patients +5 more

Cash and investments

$313.8 million

As of September 30, 2026

Cash runway

Into 2029

Under the current operating plan

Proteinuria reductions

5 of 7 patients

SLE patients with elevated baseline proteinuria in the Genrix Bio study

Complete renal responses

4 patients

Among 7 SLE patients with elevated baseline proteinuria

R&D expenses

$40.2 million

Third quarter 2026, compared with $42.0 million in third quarter 2025

Net loss

$49.4 million

Third quarter 2026, compared with $50.6 million in third quarter 2025

Second-line U.S. approval milestone

$30 million

Payment eligibility upon U.S. regulatory approval for 2L EGFR ex20ins NSCLC

First-line U.S. approval milestone

$100 million

Payment eligibility upon U.S. regulatory approval for 1L EGFR ex20ins NSCLC

Key Terms

sle, proteinuria, nda, progression-free survival

4 terms

sle medical

"with SLE and elevated baseline proteinuria"

Systemic lupus erythematosus is a chronic autoimmune disease in which the body's defense system mistakenly attacks healthy tissues, causing inflammation in the skin, joints, kidneys, blood and other organs — like a home alarm that repeatedly sounds for harmless activity. For investors, SLE matters because it defines a sizable, often under-served medical market; clinical trial results, regulatory approvals, and new therapies can drive significant revenue shifts and alter the valuations of companies developing treatments.

proteinuria medical

"rapid and marked reductions were observed"

Proteinuria is when abnormal amounts of protein are found in a person's urine. It can be a sign that the kidneys aren't working properly, since healthy kidneys usually prevent most proteins from passing into urine. Detecting proteinuria helps doctors identify and monitor kidney problems early.

nda regulatory

"Taiho initiated an NDA submission for zipalertinib"

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.

progression-free survival medical

"improvement in median progression-free survival"

Progression-free survival is the length of time during and after a treatment that a patient's disease does not get worse, measured from the start of treatment until the disease shows measurable signs of progression or the patient dies. Investors care because longer progression-free survival in clinical trials often signals that a drug is effective, improving chances of regulatory approval, market adoption, and revenue potential—think of it as a stopwatch showing how long a therapy can keep the illness at bay.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

CLN-978 (CD19 TCE) multi-dose regimen data in SLE, RA, and Sjögren’s disease will be shared in December

Velinotamig (BCMA TCE) data presented at ACR Convergence 2026; global Phase 1/2 study in autoimmune cytopenias initiated

CLN-049 (FLT3 TCE) potentially registrational Phase 2 study in R/R AML underway; updated data from the Phase 1 dose escalation study will be presented at the 2026 ASH Annual Meeting

Zipalertinib NDA submission for first-line combination therapy in EGFR ex20ins NSCLC initiated under U.S. FDA Real-Time Oncology Review program; completion expected in November

Cash and investments of $313.8 million as of September 30, 2026; runway into 2029

CAMBRIDGE, Mass., Nov. 10, 2026 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM; “Cullinan”), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, disease-modifying T cell engagers in autoimmune diseases and cancer, today provided an update on recent and anticipated business highlights and announced its financial results for the third quarter ended September 30, 2026.

“Our progress this quarter underscores our ability to execute across a differentiated and rapidly advancing portfolio. In addition to the recent clinical success and regulatory progress of zipalertinib, we have advanced velinotamig into a global study in autoimmune cytopenias and initiated a potentially registrational Phase 2 study of CLN-049 in relapsed and refractory AML,” said Nadim Ahmed, President and CEO of Cullinan Therapeutics.

“Looking ahead, we remain focused on strengthening our leadership position in the T cell engager space. This December, we will share an update for CLN-978 across our ongoing clinical trials in three autoimmune indications and will share updated data for CLN-049 at the ASH Annual Meeting. With multiple upcoming clinical catalysts and regulatory milestones, coupled with our strong balance sheet, we are well positioned to translate this momentum into meaningful progress for patients and long-term value for shareholders.”

Portfolio Highlights and 2026 Milestones

Immunology

• CLN-978 (CD19xCD3 T cell engager): Currently being evaluated in treatment-refractory moderate to severe systemic lupus erythematosus (SLE), difficult-to-treat rheumatoid arthritis (RA), and treatment-refractory moderate to severe Sjögren’s disease (SjD)
  • In a December webcast, the Company will share data in SLE, RA, and Sjögren’s disease. The update will include:
    • Multi-dose regimen data from a total of approximately 20 patients across SLE, RA, and Sjögren’s disease with a focus on initial clinical activity, biomarker data and safety.
    • Updated single target dose data with longer follow-up for responding patients with SLE and RA.
    • Initial single target dose data for patients with Sjögren’s disease.
• Velinotamig (BCMAxCD3 T cell engager): Currently being evaluated by Cullinan in relapsing and refractory immune thrombocytopenia (ITP) and warm autoimmune hemolytic anemia (wAIHA), and by Genrix Bio in treatment-refractory moderate to severe SLE in China
  • In October, following IND clearance by the U.S. FDA and HREC clearance in Australia, Cullinan initiated a global Phase 1/2 basket study in patients with relapsing and refractory ITP and wAIHA.
  • At ACR Convergence 2026, new data from the Genrix Bio Phase 1/2 study in China were shared. In 5 of 7 patients with SLE and elevated baseline proteinuria, rapid and marked reductions were observed, with 4 patients achieving a complete renal response, and a favorable safety profile was observed. The data are expected to further inform development of the BCMA-directed therapy across autoimmune diseases.
    
    

Oncology

• CLN-049 (FLT3xCD3 T cell engager): Currently being evaluated in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)
  • In October, the Company initiated a potentially registrational Phase 2 study in patients with relapsed/refractory AML. As aligned with the U.S. FDA following a positive End-of-Phase 1 meeting in July, the study incorporates a dose-optimization phase before progressing to a single-arm expansion cohort at the RP2D.
  • In November, the Company initiated a Phase 1/2 study evaluating the combination of CLN-049, venetoclax, and azacitidine in patients with newly diagnosed AML.
  • In a published ASH abstract, the Company shared updated efficacy and safety data from the Phase 1 dose escalation study in patients with relapsed/refractory AML or MDS. The updated dose escalation results will be further detailed in a poster presentation at the 2026 ASH Annual Meeting on December 13, 2026.
• Zipalertinib (EGFR ex20ins inhibitor), collaboration with Taiho Oncology: Currently being evaluated in NSCLC harboring EGFR ex20ins and other uncommon EGFR mutations
  • In October, Taiho initiated an NDA submission for zipalertinib plus chemotherapy in first-line EGFR ex20ins NSCLC under the U.S. FDA Real-Time Oncology Review program. The NDA submission is based on data from the Phase 3 REZILIENT3 trial, which met its primary endpoint at interim analysis, demonstrating a statistically significant and clinically meaningful improvement in median progression-free survival for zipalertinib plus chemotherapy compared to chemotherapy alone. These results were presented in a Presidential Symposium at IASLC 2026 WCLC. Completion of the NDA submission is expected in November.
  • An NDA for zipalertinib monotherapy for relapsed EGFR ex20ins NSCLC remains under review with a Prescription Drug User Fee Act target action date of February 27, 2027.
  • Cullinan is eligible to receive $30 million and $100 million upon U.S. regulatory approvals for the treatment of 2L and 1L EGFR ex20ins NSCLC, respectively, and a 50/50 profit share in the U.S.
  • New data from Cohort C of the Phase 2 REZILIENT2 study were presented at the ESMO Congress 2026, reinforcing the clinically meaningful intracranial antitumor activity of zipalertinib monotherapy in patients with active brain metastases.
    
    

Third Quarter 2026 Financial Results

• Cash Position: Cash, cash equivalents, short- and long-term investments, and interest receivable were $313.8 million as of September 30, 2026. Cullinan expects its cash resources to provide runway into 2029 under its current operating plan.
• R&D Expenses: Research and development expenses were $40.2 million for the third quarter of 2026, compared to $42.0 million for the same period in 2025.
• G&A Expenses: General and administrative expenses were $12.4 million for the third quarter of 2026, compared to $13.6 million for the same period in 2025.
• Net Loss: Net loss was $49.4 million for the third quarter of 2026, compared to $50.6 million for the same period in 2025.
  
  

About Cullinan Therapeutics

Cullinan Therapeutics, Inc. (Nasdaq: CGEM) is a biopharmaceutical company developing potential first- or best-in-class, disease-modifying T cell engagers 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 clinical development plans and anticipated 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, our plans regarding future data presentations, 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 trials will not be predictive of future results in connection with future studies or clinical trials; 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)

		September 30, 2026				December 31, 2025
Cash, cash equivalents, investments, and interest receivable		$	313,813			$	438,960
Total assets		$	322,559			$	448,374
Total current liabilities		$	40,130			$	37,741
Total liabilities		$	41,275			$	39,644
Total stockholders’ equity		$	281,284			$	408,730

Cullinan Therapeutics, Inc.
Consolidated Statements of Operations
(unaudited)
(in thousands, except per share amounts)

		Three Months Ended September 30,								Nine Months Ended September 30,
		2026				2025				2026				2025
Operating expenses:
Research and development		$	40,169			$	41,968			$	126,729			$	144,457
General and administrative			12,431				13,627				36,822				41,932
Total operating expenses			52,600				55,595				163,551				186,389
Loss from operations			(52,600	)			(55,595	)			(163,551	)			(186,389	)
Interest income			3,288				5,093				11,034				17,597
Other expense, net			(76	)			(108	)			(236	)			(374	)
Net loss		$	(49,388	)		$	(50,610	)		$	(152,753	)		$	(169,166	)
Basic and diluted net loss per share:
Common stock		$	(0.74	)		$	(0.77	)		$	(2.31	)		$	(2.58	)
Preferred stock		$	(7.43	)		$	(7.72	)		$	(23.06	)		$	(25.84	)
Weighted-average shares used in computing basic and diluted net loss per share:
Common stock			64,400				59,075				62,130				58,999
Preferred stock			204				648				411				648

Contacts:

Investors
Nick Smith
+1 401.241.3516
nsmith@cullinantx.com

Media 
Rose Weldon
+1 215.801.7644
rweldon@cullinantx.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What were Cullinan Therapeutics' third-quarter 2026 financial results?

Cullinan reported a $49.388 million net loss, compared with $50.610 million in the third quarter of 2025. Research and development expenses were $40.169 million, versus $41.968 million, and general and administrative expenses were $12.431 million, versus $13.627 million.

When is the FDA decision expected on Cullinan's zipalertinib monotherapy application?

The zipalertinib monotherapy application for relapsed lung cancer with EGFR exon 20 insertion mutations has an FDA target action date of February 27, 2027. The application remains under review.

What will Cullinan's December CLN-978 update include?

The update will include multi-dose regimen data from approximately 20 patients across lupus, rheumatoid arthritis and Sjögren’s disease, focusing on initial clinical activity, biomarkers and safety. It will also include longer follow-up for responding lupus and rheumatoid arthritis patients receiving a single target dose, and initial single-target-dose data in Sjögren’s disease.