Cullinan Therapeutics Provides Corporate Update and Highlights Anticipated 2026 Milestones

Rhea-AI Summary

Cullinan Therapeutics (Nasdaq: CGEM) provided a 2026 corporate update highlighting clinical and regulatory catalysts and its financial position. Key clinical milestones include planned 2026 data readouts for CLN-978 across RA, SLE and Sjögren’s (single-dose and repeat dosing), initiation of monotherapy expansion and a frontline combination study for CLN-049 with an expected RP2D decision in Q4 2026, and a rolling NDA completion for zipalertinib expected in Q1 2026 with REZILIENT3 enrollment completion in H1 2026. Cullinan reported preliminary cash, cash equivalents and investments of $439.0 million as of Dec 31, 2025, and expects runway into 2029.

Positive

• Preliminary cash and investments of $439.0M as of Dec 31, 2025
• CLN-978 readouts planned across RA, SLE, and Sjögren’s in 2026 including repeat dosing data
• CLN-049 received U.S. FDA Fast Track designation for R/R AML and plans RP2D decision in Q4 2026
• Zipalertinib rolling NDA submission expected complete in Q1 2026 with REZILIENT3 enrollment by H1 2026
• Cullinan eligible for up to $130M in U.S. regulatory milestone payments and 50/50 U.S. profit share on zipalertinib

Negative

• None.

Key Figures

Preliminary cash & investments $439.0M As of Dec 31, 2025; unaudited

Cash runway Into 2029 Based on current operating plan

Q3 2025 net loss $50.6M Quarter ended Sep 30, 2025

Cash & investments $475.5M As of Sep 30, 2025 (8-K liquidity disclosure)

ATM capacity remaining $85.6M At-the-market program per Q3 2025 10-Q

Zipalertinib U.S. milestones $130M Potential U.S. regulatory milestone payments from Taiho

CLN-049 CRc rate 30% AML at ≥6 μg/kg in Phase 1 (Nov 3, 2025 8-K)

CLN-049 CR/CRh rate 31% 12 μg/kg cohort in AML (Dec 8, 2025 8-K)

Market Reality Check

$11.14 Last Close

Volume Price up 7.68% on volume of 722,052 vs 20-day average 1,036,629, indicating a lighter-than-average participation in the move. normal

Technical Shares at $10.94, trading above the $8.17 200-day MA and about 17.9% below the $13.33 52-week high.

Peers on Argus

CGEM gained 7.68%, while close biotech peers were mixed with modest moves (e.g., AUTL -2.5%, LXRX +2.63%, PRTC +2.11%, VIGL 0%, INBX -0.67%). No peers appeared in the momentum scanner, pointing to a company-specific reaction.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 08	Clinical data update	Positive	+17.5%	Updated Phase 1 CLN-049 AML data with meaningful CR rates and manageable safety.
Dec 01	Regulatory designation	Positive	-5.5%	FDA Fast Track designation for CLN-049 in relapsed/refractory AML.
Nov 20	NDA initiation	Positive	+3.2%	Partners initiated rolling NDA submission for zipalertinib in EGFR ex20ins NSCLC.
Nov 10	Investor outreach	Neutral	+3.5%	Participation in investor conferences and ASH analyst event around CLN-049 data.
Nov 06	Earnings & update	Positive	+0.6%	Q3 2025 results plus T cell engager pipeline focus and strong cash runway.

Pattern Detected

Positive clinical and regulatory updates have more often led to upside moves, though there has been at least one notable divergence on good news.

Recent Company History

Over the last few months, Cullinan has highlighted CLN-049’s AML data and regulatory progress, including FDA Fast Track on Dec 1, 2025 and updated Phase 1 efficacy data at ASH 2025, which drove a 17.47% move on Dec 8, 2025. Zipalertinib’s rolling NDA and pivotal program were advanced in late 2025, while Q3 results confirmed cash of $475.5M and runway into 2029. Today’s corporate update extends that trajectory, detailing 2026 data and regulatory milestones and reaffirming a strong cash position of $439.0M as of Dec 31, 2025.

Market Pulse Summary

This announcement outlines a dense 2026 catalyst calendar across immunology and oncology, including CLN-978 autoimmune data readouts, CLN-049 dose expansion and frontline AML combination work, and completion of the zipalertinib rolling NDA and REZILIENT3 enrollment. It also discloses unaudited cash and investments of $439.0M as of Dec 31, 2025 and runway into 2029. Investors may focus on timely execution of these milestones, evolving efficacy and safety profiles, and future financial updates planned for late February 2026.

Key Terms

nda regulatory

"initiated a rolling submission of an NDA seeking accelerated approval"

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.

fast track designation regulatory

"In December 2025, CLN-049 received Fast Track designation for the treatment"

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.

phase 1/2 medical

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

Phase 1/2 is a combined early-stage clinical trial that first tests a new drug or treatment for safety and the right dose, then quickly expands to check if it shows any signs of working in patients. For investors, results from a Phase 1/2 study offer an early read on both risk and potential reward—like a prototype test that both confirms a product won’t harm users and suggests whether it could sell—helping guide valuation and development decisions.

measurable residual disease medical

"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.

rule 10b5-1 trading plan financial

"sale was carried out under a pre-established Rule 10b5-1 trading plan"

A Rule 10b5-1 trading plan is a pre-arranged schedule that allows company insiders to buy or sell stock at specific times, even if they have inside information. It helps prevent accusations of unfair trading by making these transactions look planned and transparent, rather than sneaky or illegal.

at-the-market program financial

"The company also has an at‑the‑market program with $85.6M capacity"

An at-the-market program is a way for a company to sell new shares of its stock gradually over time directly into the stock market, rather than all at once. This approach allows the company to raise money as needed while giving investors the opportunity to buy shares at current market prices. It helps manage the timing and price of new stock offerings, providing flexibility for both the company and investors.

AI-generated analysis. Not financial advice.

Data readouts planned for CLN-978 across all three autoimmune indications in 2026, including single dose and repeat dosing data

Company to complete monotherapy expansion cohorts to determine recommended Phase 2 dose for CLN-049 pivotal registrational study and initiate combination study in frontline AML in Q4 2026

Zipalertinib rolling NDA submission expected to be complete in Q1 2026 and full enrollment of REZILIENT3 frontline study expected in H1 2026

Preliminary cash and investments of $439.0 million as of December 31, 2025; Runway into 2029

CAMBRIDGE, Mass., Jan. 08, 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 a corporate update and shared anticipated business highlights for 2026.

“We have built strong momentum with CLN-978 and are pleased to share that we have completed multiple dose cohorts in our OUTRACE RA and OUTRACE SLE studies, and we have initiated dosing in our Sjögren’s disease study. This significant progress positions us to deliver the first company sponsored data with a CD19 T cell engager in autoimmune diseases. Throughout 2026, we will deliver data across all three indications, including important repeat dosing data in rheumatoid arthritis,” said Nadim Ahmed, President and CEO of Cullinan Therapeutics.

“Our CLN-049 program continues to advance following the presentation of compelling efficacy and favorable safety data at ASH 2025, which we believe enables an accelerated approval pathway. We plan to complete dose expansion in relapsed/refractory AML and TP53m AML to rapidly determine a recommended Phase 2 dose, while also initiating a frontline combination study this year. Additionally, 2026 marks a pivotal milestone for zipalertinib, as Taiho completes the rolling NDA submission in the beginning of the year, and completes enrollment in the frontline study REZILIENT3 in the first half of 2026. In summary, we are focused on generating multiple catalysts for our two high-priority T cell engager programs, CLN-978 and CLN-049, positioning us for a transformative year ahead.”

Portfolio Highlights and Anticipated 2026 Milestones

Immunology

• CLN-978 (CD19xCD3 bispecific T cell engager): Rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), and Sjögren’s disease (SjD)
  
• OUTRACE RA
  
  • Dose escalation is ongoing, and patients are currently being enrolled to the 30-microgram dose cohort. The 10- and 20-microgram dose cohorts are complete with no dose-limiting toxicities observed.
    
  • 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, additional 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, additional biomarker data, and preliminary clinical activity data.
    
• OUTRACE SLE
  
  • Dose escalation is ongoing, and patients are currently being enrolled in the 30-microgram dose cohort. The 10- and 20-microgram dose cohorts are complete with no dose-limiting toxicities observed.
    
  • 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, additional biomarker data, and preliminary clinical activity data.
    
• OUTRACE SjD
  
  • The Company has initiated patient dosing, and enrollment is ongoing in the 10-microgram dose cohort.
    
  • 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, additional biomarker data, and preliminary clinical activity data.
    
• Velinotamig (BCMAxCD3 bispecific T cell engager): Autoimmune diseases
  
  
  • In December 2025, Genrix Bio initiated a Phase 1 study in China in patients with autoimmune diseases, and initial clinical data from the study will be shared in Q4 2026. 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

• CLN-049 (FLT3xCD3 bispecific T cell engager): Acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)
  
  
  • In December 2025, CLN-049 received Fast Track designation for the treatment of relapsed/refractory AML from the U.S. FDA and, in an oral presentation at the 2025 ASH Annual Meeting, the Company shared compelling clinical data in a heavily pretreated all-comer population of patients with relapsed/refractory AML. The Company plans to share an update from the dose escalation portion of the study 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 November 2025, Taiho initiated a rolling submission of an NDA seeking accelerated approval of zipalertinib for the treatment of patients with relapsed EGFR ex20ins NSCLC. Taiho expects completion of the NDA submission in Q1 2026.
    
  • Taiho expects to complete enrollment of the pivotal study REZILIENT3 in 1L EGFR ex20ins NSCLC in H1 2026.
    
  • Cullinan is eligible to receive up to $130 million in payments for U.S. regulatory milestones and a 50/50 profit share in the U.S.
    
    

Cash Position and Cash Runway
Unaudited preliminary cash, cash equivalents, short- and long-term investments, and interest receivable were $439.0 million as of December 31, 2025. Consistent with prior guidance, Cullinan expects its cash resources to provide runway into 2029 under its current operating plan.

The Company expects to report its fourth quarter and full-year 2025 financial results in late February 2026 which will contain additional information required for a more complete understanding of the Company’s financial position and results of operations as of and for the year ended December 31, 2025.

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 preliminary estimates of cash, cash equivalents, short- and long-term investments, and interest receivable as of December 31, 2025, 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: the preliminary cash position reported herein reflects information available to us only at this time and may differ from our actual cash position as of December 31, 2025, including in connection with the completion of our financial statement closing procedures; 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.

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 (CGEM) report CLN-978 repeat dosing data for rheumatoid arthritis?

Cullinan plans to share initial CLN-978 repeat dosing data for RA in Q3 2026.

What is the expected timeline for CLN-049 dose expansion and RP2D determination for CGEM?

Monotherapy dose expansion cohorts are expected to start in Q2 2026 with RP2D enrollment completion targeted in Q4 2026.

When will the zipalertinib NDA submission be complete and REZILIENT3 enrollment finish for CGEM/Taiho?

Taiho expects to complete the rolling NDA submission in Q1 2026 and finish REZILIENT3 enrollment in H1 2026.

How much cash runway did Cullinan (CGEM) report at Dec 31, 2025 and how long is runway expected to last?

Unaudited cash, cash equivalents and investments were $439.0 million as of Dec 31, 2025, with runway expected into 2029.

What regulatory designation does CLN-049 have and what does that imply for CGEM timelines?

CLN-049 received Fast Track designation for relapsed/refractory AML, and Cullinan plans accelerated dose expansion and a registrational pathway in 2026.