Summary of Cullinan Therapeutics Conference Call Company Overview - **Company**: Cullinan Therapeutics (NasdaqGS:CGEM) - **Focus**: Development of best-in-class molecules for oncology and autoimmune diseases, with a portfolio centered around high-priority programs including CLN-978 for autoimmune diseases and zipalertinib for oncology [2][4] Key Programs and Developments - **Lead Program**: CLN-978, a CD19 x CD3 bispecific T cell engager, is currently in phase 1 clinical studies for systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and Sjogren's disease, with initial clinical data expected in the first half of 2026 [3][4] - **Oncology Program**: Zipalertinib TKI for EGFR exon 20 non-small cell lung cancer is planned for regulatory filing by the end of 2025 [4] Clinical Data and Study Design - **SLE and RA Studies**: Initial clinical data for SLE and RA has been shifted to the first half of 2026, with ongoing patient enrollment in global sites [3][25] - **Study Design**: The SLE study includes a modified single ascending dose study to identify a deeply B cell depleting dose while maintaining a therapeutic index [14][15] - **Eligibility Criteria Update**: Adjustments made to broaden patient eligibility, allowing those who have only received small molecule immune suppressants to participate [20][22] Therapeutic Benefits and Differentiation - **T Cell Engagers**: The potential for T cell engagers to provide therapeutic benefits without ongoing immune suppression is highlighted, with a focus on achieving durable responses [6][10] - **Differentiation of CLN-978**: High affinity binding to CD19 and a favorable cytokine window are key differentiators from other CD19 T cell engagers [8][9] Evidence and Market Potential - **RA Evidence**: Previous studies indicate that T cell engagers can provide clinical benefits through B cell depletion in RA, supporting the rationale for further development [28][30] - **Sjogren's Disease**: While evidence for T cell engagers in Sjogren's is limited, the disease's B cell-centric nature suggests potential therapeutic benefits from B cell-targeting therapies [32][33] Financial Position - **Cash Reserves**: As of the end of Q2, the company reported over $500 million in cash reserves, providing a runway into 2028 [39][41] Regulatory Pathway - **Collaboration with Genrex Bio**: Ongoing studies in China are expected to facilitate regulatory ambitions outside of China, with data generation in autoimmune disease patients aiding in the development of Cullinan's own studies [36][38] Conclusion - Cullinan Therapeutics is positioned to advance its innovative therapies in both oncology and autoimmune diseases, with a strong financial foundation and promising clinical programs aimed at addressing significant unmet medical needs in these areas [41]

Core Insights - Cullinan Therapeutics, Inc. is participating in the Stifel 2025 Virtual Immunology and Inflammation Forum, highlighting its engagement in the biopharmaceutical sector [1] - The company focuses on developing targeted therapies for autoimmune diseases and cancer, aiming to create new standards of care [3] Company Overview - Cullinan Therapeutics is a biopharmaceutical company listed on Nasdaq under the ticker CGEM, dedicated to developing modality-agnostic targeted therapies [1][3] - The company has built a diversified portfolio of clinical-stage assets that target key disease drivers and utilize the immune system to combat diseased cells [3] - Cullinan's approach includes rigorous candidate selection and development processes to fast-track promising therapeutic molecules [3] Event Participation - Jeffrey Jones, M.D., M.B.A., the Chief Medical Officer of Cullinan, will participate in a fireside chat at the Stifel forum on September 16, 2025, at 9:30 a.m. ET [1] - A webcast of the event will be available on the company's investor relations website [2]

Group 1 - Morgan Stanley's Global Healthcare Conference features Cullinan Therapeutics with CEO Nadim Ahmed and CMO Jeff Jones presenting [2] - Sean Laaman, Head of U.S. Smid-Cap Biotech Equity Research, is leading the session [1] - The conference aims to discuss key developments and insights in the healthcare sector [1]

Summary of Cullinan Therapeutics FY Conference Call Company Overview - **Company**: Cullinan Therapeutics (NasdaqGS:CGEM) - **Focus**: Development of first-in-class or best-in-class molecules targeting autoimmune diseases and cancer [7][8] Key Points Pipeline and Clinical Development - **Catalysts**: The company is at an important inflection point with several upcoming catalysts [7] - **Lead Program**: CLN-978, a CD19 x CD3 bispecific T-cell engager, is prioritized for autoimmune diseases [8] - **IND Clearance**: First company to receive IND clearance from the FDA for a CD19 T-cell engager in autoimmune diseases [9] - **Ongoing Studies**: Three studies in high unmet need indications, including lupus, rheumatoid arthritis (RA), and Sjogren's disease [9][10] - **Data Timeline**: Initial data for lupus expected in the first half of 2026, delayed from Q4 2025 due to enrollment challenges [9][25] Clinical Insights - **Mechanism of Action**: T-cell engagers can achieve deeper B-cell depletion compared to traditional monoclonal antibodies, potentially leading to disease-modifying effects [19][20] - **Safety Profile**: CLN-978 has shown a favorable safety profile in initial studies, with no significant adverse events reported [22] Market Opportunities - **Autoimmune Diseases**: Significant unmet need in RA, with nearly 1 million moderate to severe patients in the U.S. [36] - **Sjogren's Disease**: Approximately 800,000 patients in the U.S., with potential overlap with other autoimmune diseases [40] - **Belanotamab**: A BCMA x CD3 T-cell engager licensed from Generex BioHope, complementing CLN-978 by targeting plasma cells [42] Financial Position - **Cash Reserves**: Over $500 million in cash as of June 2025, providing a strong financial position to support ongoing and future programs without immediate capital raises [13][54] Strategic Partnerships - **Taiho Oncology**: Partnering for the commercialization of zipolirenib, with a 50/50 profit share in the U.S. [12][49] - **China Market**: Licensing agreements to leverage innovation from China, with initial studies planned there [16][17] Upcoming Data and Expectations - **CLN-049**: Initial data for another T-cell engager expected in Q4 2025 [55] - **RA Study**: Ongoing dosing with initial data expected in the first half of 2026 [37] Additional Insights - **Enrollment Challenges**: Difficulty in enrolling patients for lupus studies due to restrictive eligibility criteria, which have since been amended to broaden participation [25][28] - **Tissue Penetration Studies**: Plans to incorporate tissue-level B-cell depletion assessments in RA studies, which may provide additional insights into the drug's efficacy [38] This summary encapsulates the key points discussed during the conference call, highlighting Cullinan Therapeutics' strategic focus, clinical developments, market opportunities, and financial health.

Core Insights - Taiho Oncology, Inc. and Cullinan Therapeutics, Inc. announced new data from the REZILIENT1 and REZILIENT2 trials of zipalertinib, an oral EGFR tyrosine kinase inhibitor for advanced or metastatic non-small cell lung cancer (NSCLC) [1][26] - The data will be presented at the IASLC 2025 World Conference on Lung Cancer, highlighting the importance of addressing unmet medical needs in specific patient populations [1][4] REZILIENT1 Trial Summary - The REZILIENT1 trial focuses on patients with NSCLC harboring EGFR exon 20 insertion mutations who have been previously treated with amivantamab [2][5] - As of June 2025, 84 patients were enrolled, with a median of 3 prior lines of therapy; 54.8% had a history of brain metastases [5] - The confirmed objective response rate (ORR) was 27.4% with a median duration of response (mDOR) of 8.5 months, and the disease control rate (DCR) was 84.5% [7] - In patients who received prior amivantamab only, ORR was 31.5% with mDOR of 9.5 months [7] - Zipalertinib demonstrated a manageable safety profile with no new safety signals; the most common treatment-emergent adverse events included paronychia (41.7%) and anemia (38.1%) [8][9] REZILIENT2 Trial Summary - The REZILIENT2 trial evaluates zipalertinib in patients with uncommon non-exon 20 insertion EGFR mutations [3][10] - As of March 2025, 40 patients were enrolled, with a median of 2 prior lines of therapy; 30% had a history of brain metastases [10] - The overall efficacy population showed a confirmed ORR of 30% with a mDOR of 7.75 months and a DCR of 70% [17] - The most common treatment-related adverse events were paronychia (47.5%) and dermatitis acneiform (37.5%); most were grade 1 or 2 [11][12] Zipalertinib Overview - Zipalertinib is an orally available small molecule designed to target activating mutations in EGFR, specifically ex20ins mutations, while sparing wild-type EGFR [15] - It has received Breakthrough Therapy Designation from the FDA and is currently investigational [15][16] - The drug is being developed by Taiho Oncology, Inc. in collaboration with Cullinan Therapeutics, Inc. [16]

[PART I. FINANCIAL INFORMATION](index=6&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Financial Statements (unaudited)](index=6&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) The company's unaudited financials show a net loss of $118.6 million for H1 2025 and reduced total assets [Consolidated Balance Sheets](index=6&type=section&id=Consolidated%20Balance%20Sheets) Total assets decreased to $520.3 million as of June 30, 2025, driven by lower cash and investments Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $72,820 | $83,005 | | Total current assets | $275,911 | $414,668 | | Total assets | $520,329 | $621,824 | | **Liabilities & Equity** | | | | Total current liabilities | $28,058 | $30,647 | | Total liabilities | $28,183 | $31,496 | | Total stockholders' equity | $492,146 | $590,328 | | Total liabilities and stockholders' equity | $520,329 | $621,824 | [Consolidated Statements of Operations and Comprehensive Income (Loss)](index=7&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Income%20(Loss)) Net loss for H1 2025 increased to $118.6 million from $79.4 million in H1 2024 due to higher R&D expenses Statement of Operations Summary (in thousands, except per share data) | Metric | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $61,030 | $36,259 | $102,489 | $66,905 | | General and administrative | $14,768 | $13,768 | $28,305 | $26,111 | | Loss from operations | $(75,798) | $(50,027) | $(130,794) | $(93,016) | | Net loss attributable to Cullinan | $(70,055) | $(42,028) | $(118,556) | $(79,176) | | Basic and diluted net loss per share (Common) | $(1.07) | $(0.68) | $(1.81) | $(1.43) | [Consolidated Statements of Stockholders' Equity](index=8&type=section&id=Consolidated%20Statements%20of%20Stockholders'%20Equity) Stockholders' equity declined to $492.1 million by June 30, 2025, primarily due to the net loss - The primary driver for the decrease in stockholders' equity in the first half of 2025 was the **net loss of $118.6 million**[24](index=24&type=chunk) - In the first half of 2024, the company raised **net proceeds of $262.7 million** from the issuance of common stock and pre-funded warrants[26](index=26&type=chunk)[54](index=54&type=chunk) [Consolidated Statements of Cash Flows](index=10&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations was $100.8 million for H1 2025, contributing to a $10.2 million decrease in cash Cash Flow Summary (in thousands) | Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(100,764) | $(74,538) | | Net cash provided by (used in) investing activities | $90,206 | $(172,156) | | Net cash provided by financing activities | $373 | $263,281 | | **Net (decrease) increase in cash** | **$(10,185)** | **$16,587** | [Notes to the Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20the%20Consolidated%20Financial%20Statements) The company has sufficient cash for the next twelve months and expensed a $20.0 million upfront license fee - The company believes its cash, cash equivalents, and investments totaling **$510.9 million** as of June 30, 2025, will fund operations and capital expenditures for at least the next twelve months[34](index=34&type=chunk) - In June 2025, Cullinan entered into a license agreement with Genrix for velinotamig, paying a **$20.0 million upfront fee** which was recorded as R&D expense[44](index=44&type=chunk)[45](index=45&type=chunk)[47](index=47&type=chunk) - Under the Taiho co-development agreement for zipalertinib, Cullinan recorded its share of R&D costs from Taiho totaling **$7.8 million** and **$13.4 million** for the three and six months ended June 30, 2025, respectively[50](index=50&type=chunk) - In April 2024, Cullinan raised **net proceeds of $262.7 million** through a private placement of common stock and pre-funded warrants[54](index=54&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) R&D expenses rose due to a $20.0 million license fee, while cash reserves are deemed sufficient for operations [Overview](index=21&type=section&id=Overview) The company is a clinical-stage biopharmaceutical firm focused on immunology and oncology programs - **Immunology Pipeline:** - **CLN-978 (CD19xCD3):** Phase 1 trials ongoing in SLE, RA, and SjD, with initial SLE data expected in Q4 2025 - **Velinotamig (BCMAxCD3):** Licensed from Genrix; a Phase 1 trial in autoimmune diseases is planned by Genrix in China by year-end 2025[78](index=78&type=chunk)[80](index=80&type=chunk) - **Oncology Pipeline:** - **Zipalertinib (EGFR inhibitor):** Co-developed with Taiho, Phase 2b met its primary endpoint in NSCLC, with an NDA submission planned by year-end 2025 - **CLN-049 (FLT3xCD3):** Phase 1 trial ongoing in AML, with data expected in Q4 2025 - **CLN-619 (MICA/B antibody):** Phase 1 continues in NSCLC and multiple myeloma - **CLN-617 (IL-2/IL-12 fusion protein):** Phase 1 ongoing in advanced solid tumors[79](index=79&type=chunk)[80](index=80&type=chunk)[88](index=88&type=chunk) - The company recently **discontinued development of CLN-619** in gynecological cancers and **terminated the license for CLN-418** to focus resources[82](index=82&type=chunk)[83](index=83&type=chunk) [Results of Operations](index=27&type=section&id=Results%20of%20Operations) Operating expenses increased significantly, driven by a one-time $20.0 million R&D in-licensing fee - The **$24.8 million increase in Q2 2025 R&D expenses** was primarily driven by a **$20.0 million upfront license fee** for velinotamig, along with higher clinical and personnel costs[99](index=99&type=chunk) - The **$35.6 million increase in H1 2025 R&D expenses** was also mainly due to the **$20.0 million velinotamig fee**, plus increases in clinical costs ($9.7 million) and personnel costs ($5.6 million)[100](index=100&type=chunk) Research and Development Expenses by Category (in thousands) | Category | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--- | :--- | :--- | :--- | :--- | | Clinical-stage product candidates | $25,022 | $23,689 | $51,661 | $43,326 | | Early-stage programs | $1,986 | $1,455 | $3,008 | $2,816 | | R&D personnel and operations | $9,741 | $7,236 | $19,572 | $13,724 | | License agreement obligations | $20,115 | $25 | $20,153 | $50 | | Equity-based compensation | $4,166 | $3,854 | $8,095 | $6,989 | | **Total R&D Expenses** | **$61,030** | **$36,259** | **$102,489** | **$66,905** | [Liquidity and Capital Resources](index=29&type=section&id=Liquidity%20and%20Capital%20Resources) The company holds $510.9 million in cash and investments, sufficient for at least the next twelve months - As of June 30, 2025, the company had **$510.9 million in cash, cash equivalents, and investments**[105](index=105&type=chunk) - The company expects its current capital to fund operations through **at least the next twelve months** from the financial statement issuance date[106](index=106&type=chunk) - The company has an at-the-market (ATM) equity offering program with **$85.6 million remaining available** for sale as of June 30, 2025[109](index=109&type=chunk) Cash Flow Summary (in thousands) | Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(100,764) | $(74,538) | | Net cash provided by (used in) investing activities | $90,206 | $(172,156) | | Net cash provided by financing activities | $373 | $263,281 | [Quantitative and Qualitative Disclosures About Market Risk](index=33&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section is not applicable as the company qualifies as a smaller reporting company - As a smaller reporting company, Cullinan is **not required to provide the information** for this item[126](index=126&type=chunk) [Controls and Procedures](index=33&type=section&id=Item%204.%20Controls%20and%20Procedures) Disclosure controls and procedures were deemed effective with no material changes to internal controls - The Principal Executive Officer and Principal Financial Officer concluded that **disclosure controls and procedures were effective** as of June 30, 2025[127](index=127&type=chunk) - **No changes occurred** during the fiscal quarter ended June 30, 2025, that have materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[129](index=129&type=chunk) [PART II. OTHER INFORMATION](index=36&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=36&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings - Cullinan is not currently party to any litigation or legal proceedings that management believes are probable to have a **material adverse effect** on the business[131](index=131&type=chunk) [Risk Factors](index=36&type=section&id=Item%201A.%20Risk%20Factors) A new risk factor was added related to reduced reporting requirements as a smaller reporting company - A new risk factor has been added: due to its qualification as a smaller reporting company, the company will be subject to reduced reporting requirements, which could make its **common stock less attractive** to investors[133](index=133&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=36&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This item is not applicable for the reporting period [Defaults Upon Senior Securities](index=36&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable for the reporting period [Mine Safety Disclosures](index=36&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable for the reporting period [Other Information](index=36&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted, modified, or terminated a Rule 10b5-1 trading arrangement - No directors or officers adopted, modified, or terminated a **Rule 10b5-1 trading plan** during the fiscal quarter[136](index=136&type=chunk) [Exhibits](index=37&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed, including a new license agreement and officer certifications

[Executive Summary](index=1&type=section&id=Executive%20Summary) Cullinan Therapeutics announced Q2 2025 financial results, pipeline updates for CLN-978, velinotamig, and zipalertinib, and new board appointments [Corporate Update & Q2 2025 Financial Results Announcement](index=1&type=section&id=Corporate%20Update%20%26%20Q2%202025%20Financial%20Results%20Announcement) Cullinan Therapeutics announced Q2 2025 financial results, pipeline advancements for CLN-978 and velinotamig, zipalertinib's pivotal results, and new board appointments - CLN-978 program is actively enrolling across Phase 1 studies in **systemic lupus erythematosus (SLE)**, **rheumatoid arthritis (RA)**, and **Sjögren's disease**[1](index=1&type=chunk) - **BCMA-directed bispecific T cell engager velinotamig** was in-licensed from Genrix Bio[1](index=1&type=chunk) - **Zipalertinib REZILIENT1 pivotal results** were shared at ASCO 2025 and published in the Journal of Clinical Oncology[1](index=1&type=chunk) - The company appointed **Mittie Doyle, M.D.**, and **Andrew Allen, M.D., Ph.D.**, to its Board of Directors[1](index=1&type=chunk) [CEO Commentary](index=1&type=section&id=CEO%20Commentary) CEO Nadim Ahmed emphasized strong execution in immunology and oncology pipelines, highlighting CLN-978, velinotamig, zipalertinib, and a robust cash position - **Strong execution** in advancing the CLN-978 program across three active studies in SLE, RA, and Sjögren's disease[2](index=2&type=chunk) - The addition of **velinotamig** further solidified leadership in T cell engager development for autoimmune diseases[2](index=2&type=chunk) - **Pivotal Phase 2b REZILIENT1 study results** for zipalertinib were shared at the 2025 ASCO Annual Meeting[3](index=3&type=chunk) - **Cash and investments** totaled **$510.9 million** as of June 30, 2025, providing a runway into 2028[3](index=3&type=chunk) [Portfolio Highlights](index=2&type=section&id=Portfolio%20Highlights) Cullinan Therapeutics provided updates on its diverse immunology and oncology clinical-stage programs, detailing progress and upcoming milestones [Immunology Programs](index=2&type=section&id=Immunology%20Programs) The immunology pipeline is advancing with CLN-978 in multiple Phase 1 studies and the in-licensed velinotamig for autoimmune diseases [CLN-978 (CD19xCD3 bispecific T cell engager)](index=2&type=section&id=CLN-978%20(CD19xCD3%20bispecific%20T%20cell%20engager)) CLN-978 is actively enrolling in global Phase 1 studies for SLE, RA, and Sjögren's disease, with initial SLE data expected in Q4 2025 - Global Phase 1 study in SLE is enrolling in the United States, Europe, and Australia, with initial safety and B cell depletion data from Part A expected in **Q4 2025**[4](index=4&type=chunk) - Phase 1 study in active, difficult-to-treat rheumatoid arthritis is enrolling in Europe, with initial data expected during the **first half of 2026**[4](index=4&type=chunk) - Global Phase 1 study in active, moderate to severe Sjögren's disease is enrolling in the U.S. and active in Europe[4](index=4&type=chunk) [Velinotamig (BCMAxCD3 bispecific T cell engager)](index=3&type=section&id=Velinotamig%20(BCMAxCD3%20bispecific%20T%20cell%20engager)) Cullinan licensed velinotamig globally (ex-Greater China) for $20 million upfront, with Genrix Bio initiating a Phase 1 study in China by late 2025 - An **exclusive global (ex-Greater China) license agreement** was made with Genrix Bio for velinotamig, including an **upfront license fee of $20 million**[7](index=7&type=chunk) - Genrix Bio is eligible for up to **$292 million in development and regulatory milestones**, plus up to an additional **$400 million in sales-based milestones**, and tiered royalties[7](index=7&type=chunk) - Genrix Bio plans to initiate a Phase 1 study in autoimmune diseases in China by the **end of 2025**[7](index=7&type=chunk) [Oncology Programs](index=3&type=section&id=Oncology%20Programs) The oncology pipeline advanced with zipalertinib's pivotal results and upcoming NDA, alongside ongoing enrollment for CLN-049, CLN-619, and CLN-617 [Zipalertinib (EGFR ex20ins inhibitor), collaboration with Taiho Oncology](index=3&type=section&id=Zipalertinib%20(EGFR%20ex20ins%20inhibitor)%2C%20collaboration%20with%20Taiho%20Oncology) Zipalertinib's pivotal REZILIENT1 results were published, with Taiho planning an NDA submission by late 2025 and frontline study enrollment completion in H1 2026 - **Pivotal Phase 2b REZILIENT1 results** were shared at the 2025 ASCO Annual Meeting and published in the Journal of Clinical Oncology[7](index=7&type=chunk) - Taiho plans to submit an **NDA in relapsed EGFR ex20ins NSCLC** by the **end of 2025**[7](index=7&type=chunk) - Taiho expects to complete enrollment of the pivotal study REZILIENT3 in 1L EGFR ex20ins NSCLC in the **first half of 2026**[7](index=7&type=chunk) - Initial data from REZILIENT2 cohorts (uncommon EGFR mutations, active brain metastases) will be shared at **IASLC 2025 WCLC** and **ESMO Congress 2025**[7](index=7&type=chunk) [CLN-049 (FLT3xCD3 bispecific T cell engager)](index=4&type=section&id=CLN-049%20(FLT3xCD3%20bispecific%20T%20cell%20engager)) Enrollment for CLN-049 continues in Phase 1 studies for AML/MDS, with clinical data anticipated in Q4 2025 - Enrollment continues in the Phase 1 study for relapsed/refractory AML or MDS, with clinical data expected in **Q4 2025**[10](index=10&type=chunk) - Enrollment also continues in the Phase 1 study for patients with measurable minimal residual disease in AML[10](index=10&type=chunk) [CLN-619 (Anti-MICA/MICB monoclonal antibody)](index=4&type=section&id=CLN-619%20(Anti-MICA%2FMICB%20monoclonal%20antibody)) CLN-619 enrollment continues in Phase 1 expansion cohorts for NSCLC and relapsed/refractory multiple myeloma - Enrollment continues in Phase 1 expansion cohorts for **NSCLC** and in the Phase 1 study for **relapsed/refractory multiple myeloma**[10](index=10&type=chunk) [CLN-617 (IL-2 and IL-12 cytokine fusion protein)](index=4&type=section&id=CLN-617%20(IL-2%20and%20IL-12%20cytokine%20fusion%20protein)) Enrollment for CLN-617 continues in its Phase 1 study for patients with advanced solid tumors - Enrollment continues in the Phase 1 study for patients with **advanced solid tumors**[10](index=10&type=chunk) [Corporate Updates](index=4&type=section&id=Corporate%20Updates) Cullinan Therapeutics announced new appointments to its Board of Directors, bringing significant expertise in immunology and oncology [Board of Directors Appointments](index=4&type=section&id=Board%20of%20Directors%20Appointments) Cullinan appointed Drs Mittie Doyle and Andrew Allen to its Board, effective August 7, 2025, while Drs Martin and Ryan resigned - **Mittie Doyle, M.D.**, and **Andrew Allen, M.D., Ph.D.**, were appointed to the Board of Directors, effective August 7, 2025[8](index=8&type=chunk) - Dr. Doyle brings extensive **immunology clinical development expertise**, and Dr. Allen brings extensive **oncology clinical development experience**[8](index=8&type=chunk) - **Anne-Marie Martin, Ph.D.**, and **David Ryan, M.D.**, resigned from Cullinan's Board of Directors effective August 7, 2025[8](index=8&type=chunk) [Financial Results](index=4&type=section&id=Financial%20Results) Cullinan Therapeutics reported its Q2 2025 financial performance, detailing cash position, operating expenses, and net loss [Second Quarter 2025 Financial Summary](index=4&type=section&id=Second%20Quarter%202025%20Financial%20Summary) Cullinan reported a **$510.9 million** cash position as of June 30, 2025, with increased R&D expenses and a widened net loss for Q2 2025 Key Financial Highlights for Q2 2025 | Metric | Q2 2025 (Millions) | Q2 2024 (Millions) | Change (YoY) | | :-------------------- | :------------------ | :------------------ | :------------------ | | Cash Position (as of June 30) | $510.9 | N/A | N/A | | R&D Expenses | $61.0 | $36.3 | +$24.7 (+68.0%) | | G&A Expenses | $14.8 | $13.8 | +$1.0 (+7.2%) | | Net Loss | $(70.1) | $(42.0) | $(28.1) (-66.9%) | - **Cash, cash equivalents, short- and long-term investments, and interest receivable** totaled **$510.9 million** as of June 30, 2025, providing runway into 2028[11](index=11&type=chunk) [Selected Condensed Consolidated Balance Sheet Data](index=7&type=section&id=Selected%20Condensed%20Consolidated%20Balance%20Sheet%20Data) As of June 30, 2025, Cullinan's cash, investments, total assets, and stockholders' equity all decreased compared to December 31, 2024 Selected Condensed Consolidated Balance Sheet Data (in thousands) | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | Change (in thousands) | | :------------------------------------------ | :-------------- | :------------------ | :------------------ | | Cash, cash equivalents, investments, and interest receivable | $510,898 | $606,917 | $(96,019) | | Total assets | $520,329 | $621,824 | $(101,495) | | Total current liabilities | $28,058 | $30,647 | $(2,589) | | Total liabilities | $28,183 | $31,496 | $(3,313) | | Total stockholders' equity | $492,146 | $590,328 | $(98,182) | [Consolidated Statements of Operations](index=8&type=section&id=Consolidated%20Statements%20of%20Operations) Total operating expenses significantly increased for Q2 and H1 2025, primarily due to higher R&D, leading to a widened net loss Consolidated Statements of Operations (Three Months Ended June 30, in thousands, except per share amounts) | Metric | Q2 2025 (in thousands) | Q2 2024 (in thousands) | Change (YoY) | | :------------------------------------------ | :-------------- | :-------------- | :------------------ | | Research and development | $61,030 | $36,259 | +$24,771 (+68.3%) | | General and administrative | $14,768 | $13,768 | +$1,000 (+7.3%) | | Total operating expenses | $75,798 | $50,027 | +$25,771 (+51.5%) | | Loss from operations | $(75,798) | $(50,027) | $(25,771) (-51.5%) | | Interest income | $5,924 | $8,071 | $(2,147) (-26.6%) | | Net loss attributable to Cullinan | $(70,055) | $(42,028) | $(28,027) (-66.7%) | | Basic and diluted net loss per share (Common stock) | $(1.07) | $(0.68) | $(0.39) (-57.4%) | Consolidated Statements of Operations (Six Months Ended June 30, in thousands, except per share amounts) | Metric | H1 2025 (in thousands) | H1 2024 (in thousands) | Change (YoY) | | :------------------------------------------ | :-------------- | :-------------- | :------------------ | | Research and development | $102,489 | $66,905 | +$35,584 (+53.2%) | | General and administrative | $28,305 | $26,111 | +$2,194 (+8.4%) | | Total operating expenses | $130,794 | $93,016 | +$37,778 (+40.6%) | | Loss from operations | $(130,794) | $(93,016) | $(37,778) (-40.6%) | | Interest income | $12,504 | $13,764 | $(1,260) (-9.2%) | | Net loss attributable to Cullinan | $(118,556) | $(79,176) | $(39,380) (-49.7%) | | Basic and diluted net loss per share (Common stock) | $(1.81) | $(1.43) | $(0.38) (-26.6%) | [About Cullinan Therapeutics](index=5&type=section&id=About%20Cullinan%20Therapeutics) Cullinan Therapeutics is a biopharmaceutical company focused on developing transformative clinical-stage assets for autoimmune diseases and cancer [Company Overview](index=5&type=section&id=Company%20Overview) Cullinan Therapeutics is a biopharmaceutical company developing a diversified portfolio of clinical-stage assets for autoimmune diseases and cancer - Cullinan Therapeutics, Inc. is a biopharmaceutical company dedicated to creating **new standards of care** for patients[12](index=12&type=chunk) - The company has strategically built a **diversified portfolio of clinical-stage assets** targeting autoimmune diseases and cancer[12](index=12&type=chunk) - It is anchored in deep expertise in **oncology, immunology, and translational medicine** to develop transformative therapeutics[12](index=12&type=chunk) [Forward-Looking Statements](index=5&type=section&id=Forward-Looking%20Statements) This section provides a standard disclaimer regarding forward-looking statements, outlining inherent risks and uncertainties [Disclaimer and Risk Factors](index=5&type=section&id=Disclaimer%20and%20Risk%20Factors) This disclaimer highlights that forward-looking statements are subject to known and unknown risks and uncertainties, with no obligation to update them - The press release contains **forward-looking statements** regarding preclinical and clinical developments, therapeutic potential, R&D activities, future data presentations, and cash runway[13](index=13&type=chunk) - Forward-looking statements are subject to **known and unknown risks and uncertainties**, including regulatory timing, clinical trial success, intellectual property, manufacturing, and global economic conditions[14](index=14&type=chunk)[15](index=15&type=chunk) - The company disclaims any obligation to update such forward-looking statements, except as required by law[15](index=15&type=chunk) [Contacts](index=9&type=section&id=Contacts) This section provides contact information for investor relations and media inquiries [Investor and Media Relations](index=9&type=section&id=Investor%20and%20Media%20Relations) Contact details are provided for investor relations and media inquiries - Investors Contact: **Nick Smith**, +1 401.241.3516, nsmith@cullinantx.com[20](index=20&type=chunk) - Media Contact: **Rose Weldon**, +1 215.801.7644, rweldon@cullinantx.com[20](index=20&type=chunk)

Core Insights - Cullinan Therapeutics is advancing its CLN-978 program across three active Phase 1 studies targeting systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and Sjögren's disease, while also in-licensing the BCMA-directed bispecific T cell engager velinotamig from Genrix Bio [1][2][4] - The company reported a net loss of $70.1 million for Q2 2025, compared to a net loss of $42.0 million for the same period in 2024, indicating increased operational expenses [9][13] - Cullinan has a strong cash position of $510.9 million as of June 30, 2025, providing a runway into 2028 for ongoing and future projects [9][10] Immunology Updates - The global Phase 1 study for CLN-978 in moderate to severe SLE is currently enrolling in the U.S., Europe, and Australia, with initial safety and B cell depletion data expected in Q4 2025 [4] - The Phase 1 study for active, difficult-to-treat RA is enrolling in Europe, with initial data anticipated in the first half of 2026 [4] - The Phase 1 study for moderate to severe Sjögren's disease is also enrolling in the U.S. and Europe following regulatory approval [4] Oncology Developments - Results from the pivotal Phase 2b portion of the REZILIENT1 study of zipalertinib were shared at the 2025 ASCO Annual Meeting, with further data expected at upcoming medical conferences [3][8] - Taiho Oncology plans to submit a New Drug Application (NDA) for zipalertinib in relapsed EGFR ex20ins NSCLC by the end of 2025, with enrollment for the pivotal REZILIENT3 study expected to complete in the first half of 2026 [3][8] - Clinical data for CLN-049, targeting relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), is set to be shared in Q4 2025 [8] Corporate Governance - The company appointed Dr. Mittie Doyle and Dr. Andrew Allen to its Board of Directors, effective August 7, 2025, bringing significant expertise in immunology and oncology [6] - Drs. Anne-Marie Martin and David Ryan will resign from the Board effective the same date [6] Financial Overview - Research and development expenses for Q2 2025 were $61.0 million, up from $36.3 million in Q2 2024, reflecting increased investment in clinical programs [9][13] - General and administrative expenses rose to $14.8 million in Q2 2025 from $13.8 million in the same period last year [13] - The total operating expenses for Q2 2025 were $75.8 million, compared to $50.0 million in Q2 2024 [13]

Company Overview - Cullinan Therapeutics, Inc. (NASDAQ: CGEM) is a biopharmaceutical company that employs a modality-agnostic approach to drug development, targeting biological mechanisms in oncology and autoimmune conditions [1] Business Strategy - The company selects the most effective modality for each therapeutic target, indicating a flexible strategy that adapts to various treatment needs [1] Partnerships - Cullinan Therapeutics engages in partnerships to enhance its drug development capabilities, which may provide additional resources and expertise [1]

Core Viewpoint - The collaboration between Zhixiang Jintai and Cullinan Therapeutics aims to accelerate the global development of GR1803, a bispecific antibody for treating relapsed/refractory multiple myeloma, marking a significant milestone in Zhixiang Jintai's global strategy and innovation transformation [2]. Group 1 - Zhixiang Jintai announced an overseas licensing agreement with Cullinan Therapeutics, granting Cullinan global development, production, and commercialization rights for GR1803 outside Greater China, while retaining rights in mainland China [1]. - The agreement includes an upfront payment of $20 million, potential milestone payments up to $692 million, and tiered royalties based on net sales outside Greater China [1]. - GR1803 is currently in Phase 2 clinical trials and was included in the list of breakthrough therapies by the Chinese National Medical Products Administration [2]. Group 2 - SinoMed, established in March 2022, provides business development services for biopharmaceutical companies seeking overseas collaborations, with a team experienced in cross-border licensing transactions [3]. - The SinoMed team has evaluated over 300 projects and facilitated collaborations with more than 20 domestic companies, completing transactions for three projects across various therapeutic areas [3].