Cullinan Therapeutics, Inc.

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Commencing on December 31, 2025, we will be a smaller reporting company due to our qualification at June 30, 2025. We cannot be certain if the reduced reporting requirements applicable to smaller reporting companies could make our common stock less attractive to investors.

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As of January 1, 2025, we were a large accelerated filer and were subject to all of the related compliance or disclosure requirements applicable to a large accelerated filer. Based on the market value of our common stock that was held by non-affiliates as of June 30, 2025 and our annual revenues for the fiscal year ended December 31, 2024, we will be a smaller reporting company effective December 31, 2025 and are able to immediately avail ourselves of the reduced disclosure requirements permitted for smaller reporting companies. As a smaller reporting company, we will be permitted and intend to rely on exemptions from certain compliance and disclosure requirements that are applicable to other public companies that are not smaller reporting companies, including not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act and reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements. We may take advantage of scaled disclosures available to smaller reporting companies until the fiscal year following the determination that either (i) the market value of our voting and non-voting common stock held by non-affiliates is greater than $700 million, as measured on the last business day of the most recently completed second fiscal quarter, or (ii) the market value of our voting and non-voting common stock held by non-affiliates, as measured on the last business day of our most recently completed second fiscal quarter, is less than $700 million but greater than $250 million and our annual revenues during our most recently completed fiscal year are greater than $100 million. We cannot predict if investors will find our common stock less attractive because we may rely on these exemptions. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and our stock price may be more volatile.

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Difficulty in enrolling patients has delayed, and in the future could delay or prevent, clinical trials of our product candidates and ultimately delay or prevent regulatory approval.

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Identifying and qualifying patients to participate in clinical trials of our product candidates is critical to our success. The timing of completion of our clinical trials depends in part on the speed at which we can recruit patients to participate in testing our product candidates, and we have experienced delays in the past and may experience delays in the future in our clinical trials if we encounter difficulties in enrollment. We may not be able to initiate or continue clinical trials for our product candidates if we are unable to locate and enroll enough eligible patients to participate in these clinical trials as required by the FDA or similar regulatory authorities outside the U.S., or as needed to provide appropriate statistical power for a given clinical trial. For example, in early phase autoimmune disease development, identification of patients with appropriate disease severity and/or willingness to accept the potential risks associated with a novel approach to treating their disease could impair enrollment.

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In addition to the potentially small populations, the eligibility criteria of our planned clinical trials for some of our product candidates will further limit the pool of available clinical trial participants as we require that patients have specific characteristics, such as a certain severity or stage of disease progression, to include them in a clinical trial. For example, in the ongoing Phase 1 clinical trial for CLN-978 in patients with moderate to severe SLE in the U.S., we experienced more screening failures than anticipated due to our initial eligibility criteria, leading to a delay in enrollment in the clinical trial.

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Additionally, the process of finding eligible patients may prove costly. We also may not be able to identify, recruit, and enroll a sufficient number of patients to complete our clinical studies because of the perceived risks and benefits of the product candidate under clinical trial, the availability and efficacy of competing therapies and clinical trials, the proximity and availability of clinical trial sites for prospective patients, the availability of patients with appropriate disease severity and extent of prior therapy in autoimmune disease indications, the availability of genetic sequencing information for patient tumors so that we can identify patients with the targeted genetic mutations for our oncology studies, and the patient referral practices of physicians. If patients are unwilling to participate in our studies for any reason, the timeline for recruiting patients, conducting studies, and obtaining regulatory approval of potential products may be delayed.

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The enrollment of patients further depends on many factors, including:

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the design of the clinical trial;

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our ability to enroll a diverse patient base in our clinical trials to meet FDA recommended guidance;

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reporting of the preliminary results of any of our clinical trials;

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availability of investigational medicinal product(s);

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the risk that patients enrolled in clinical trials will drop out of the clinical trials before clinical trial completion; and

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factors we may not be able to control, such as future pandemics that may limit patients, principal investigators or staff or clinical site availability.

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In addition, our clinical trials will compete with other clinical trials for product candidates that are in the same therapeutic areas as our product candidates, and this competition will reduce the number and types of patients available to us because some patients who might have opted to enroll in our clinical trials may instead opt to enroll in a clinical trial being conducted by one of our competitors. Since the number of qualified clinical investigators is limited, we expect to conduct some of our clinical trials at the same clinical trial sites that some of our competitors use, which will reduce the number of patients who are available for our clinical trials at such clinical trial sites. Moreover, because certain of our product candidates represent a departure from more commonly used methods for autoimmune diseases or cancer treatment and because certain of our product candidates have not been tested in humans before, potential patients and their doctors may be inclined to use conventional therapies, such as conventional immune suppressing medications in autoimmune diseases or chemotherapy in oncology, rather than enroll patients in any future clinical trial of our product candidates.

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If we experience delays in the completion of, or termination of, any clinical trial of our product candidates, the commercial prospects of our product candidates will be harmed, and our ability to generate product revenue from any of these product candidates could be delayed or prevented.