Accessibility StatementSkip Navigation "Uncommon non-exon 20 insertion EGFR mutations represent a significant clinical challenge, as they exhibit variable and often suboptimal responses to currently approved tyrosine kinase inhibitors," said Hibiki Udagawa, MD, PhD, thoracic medical oncologist, National Cancer Hospital East, Japan. Â "We are pleased to present the interim data from the uncommon non-ex20ins EGFR mutations cohort from the REZILIENT2 trial, potentially demonstrating the need for novel, targete ...

[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].

Cullinan Therapeutics Licensing of velinotamig (BCMAxCD3) from Genrix Bio June 2025 © CULLINAN THERAPEUTICS, INC. ALL RIGHTS RESERVED. CONFIDENTIAL AND PROPRIETARY Important Notice and Disclaimers This presentation 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 Cullinan's beliefs and expectations regarding the potential benefits of, and pl ...

Summary of Cullinan Therapeutics (CGEM) Conference Call Company Overview - **Company**: Cullinan Therapeutics (CGEM) - **Event**: Conference Call regarding licensing agreement with Generics Bio for velanatomig - **Date**: June 04, 2025 Key Points Licensing Agreement - Cullinan Therapeutics entered into a global exclusive license agreement with Generics Bio for velanatomig, a BCMA by CD3 bispecific T cell engager, for all indications outside of Greater China [3][5] - The agreement allows Generics Bio to conduct a Phase I study in China for autoimmune diseases, expected to begin later in 2025 [7][15] Strategic Importance - The deal is seen as a strategic opportunity to enhance Cullinan's leadership in T cell engager development for autoimmune diseases [6][25] - Velanatomig is expected to complement CLN978, another bispecific T cell engager targeting CD19, allowing for a broader range of treatment options for autoimmune diseases [7][10][26] Clinical Development - Velanatomig targets BCMA, which is crucial for diseases driven by long-lived plasma cells, while CLN978 targets CD19, affecting B cell maturation [11][12] - The combination of these two agents aims to provide a comprehensive approach to treating autoimmune diseases through both B cell and plasma cell depletion [10][26] Financial Aspects - Cullinan will pay Generics Bio an upfront fee of $20 million for the licensing rights [21] - Generics Bio is eligible for up to $292 million in development and regulatory milestones and up to $400 million in sales-based milestones, along with tiered royalties [21] Market Context - The prevalence of autoimmune diseases is increasing, creating a demand for effective treatments that allow patients to reduce reliance on chronic immunosuppressive therapies [9][10] - The company maintains a cash runway into 2028, allowing for continued investment in its clinical programs despite market challenges [21][26] Safety and Efficacy - Initial clinical data for velanatomig in multiple myeloma shows promising efficacy, with a higher overall response rate compared to existing therapies [17][42] - Safety profiles for both velanatomig and CLN978 are expected to be favorable in autoimmune disease settings, with lower rates of cytokine release syndrome (CRS) anticipated [30][36] Future Directions - Cullinan plans to leverage data from Generics Bio's Phase I study to accelerate its own global clinical development plans for velanatomig [24][26] - The company is focused on matching the right therapeutic targets with the appropriate patient populations to maximize treatment efficacy [46] Additional Insights - The agreement with Generics Bio is part of a broader strategy to expand Cullinan's immunology portfolio, which is expected to yield high-impact programs and value-driving catalysts [26] - The development of a subcutaneous formulation for velanatomig is underway, which is anticipated to further improve safety profiles in autoimmune disease patients [36][45] This summary encapsulates the key aspects of the conference call, highlighting the strategic, clinical, and financial implications of the licensing agreement and the broader context of Cullinan Therapeutics' operations in the autoimmune disease market.

Core Insights - Cullinan Therapeutics has advanced its leadership in T cell engager (TCE) development for autoimmune diseases, with both a CD19 TCE and BCMA TCE in its pipeline [1] - The company has strengthened its portfolio of autoimmune programs, aiming to address a broader range of diseases while ensuring cash runway into 2028 [1][5] - Cullinan has entered into an agreement with Genrix Bio for an exclusive global license to velinotamig, a BCMAxCD3 bispecific T cell engager, which has shown promising efficacy in treating relapsed/refractory multiple myeloma [2][3] Company Developments - Velinotamig has demonstrated potential best-in-class efficacy at the Phase 2 target dose in nearly 50 patients with relapsed/refractory multiple myeloma [2] - The agreement includes an upfront license fee of $20 million, with potential future payments of up to $292 million in development and regulatory milestones, plus up to $400 million in sales-based milestones [4] - Cullinan plans to leverage data from Genrix's Phase 1 study in China to accelerate global clinical development of velinotamig in autoimmune diseases [3][4] Industry Context - T cell engagers are viewed as the next wave of innovation in autoimmune diseases, with BCMA as a promising target for a precise and potentially disease-modifying approach [3] - The collaboration with Genrix Bio is expected to enhance Cullinan's capabilities in developing therapies for autoimmune diseases, addressing the needs of a wider patient population [4][10]

Summary of the Conference Call on Cell Therapy and Autoimmune Diseases Industry Overview - The discussion focuses on the emerging field of cell therapy, particularly T cell engagers and CAR T therapies, and their applications in treating autoimmune diseases alongside oncology applications [1][2]. Key Companies and Their Innovations Cullinan - Cullinan is exploring T cell engagers to redirect T cells for depleting aberrant immune cells, particularly B cells, in autoimmune diseases [3]. - The company aims to make T cell redirecting therapies accessible in community-based centers, enhancing patient access [3]. Autolus - Autolus has launched a CD19 CAR T product approved for acute leukemia, demonstrating a strong safety profile and exceptional activity, leading to long-term remissions in advanced disease patients [4][5]. - The company is also looking to expand into the autoimmune space, believing that their product's features will be beneficial [6]. Caballetta - Caballetta focuses on developing cellular therapies specifically for autoimmune diseases, with their lead product ResiCel entering phase three trials for myositis [9][10]. - The company has agreements with the FDA for multiple cohorts in various trials, targeting diseases like lupus and multiple sclerosis [11]. Core Insights and Arguments - The panelists agree on the significant unmet need in autoimmune diseases and the potential for their therapies to provide meaningful clinical advances [8]. - T cell engagers have shown promise in achieving disease-modifying benefits, with reports indicating deep B cell depletion and symptom improvement in treated patients [14][15]. - The safety profile of these therapies is emphasized as a key differentiator in a market with high unmet needs [11][12]. Clinical Development and Regulatory Pathways - The discussion highlights the importance of understanding patient subtypes and tailoring treatment strategies based on disease severity and pathology [41]. - There is a consensus that the regulatory path for T cell engagers may differ from traditional drug approvals, with a focus on therapeutic benefit and safety [63][64]. Market Dynamics and Future Outlook - The panelists predict a competitive landscape in the autoimmune therapy market, with multiple modalities coexisting rather than competing fiercely [13]. - The potential for bispecific therapies to transform treatment paradigms is acknowledged, with expectations for improved efficacy and safety profiles [32][38]. - The market for autoimmune therapies is seen as distinct from oncology, with different pricing and patient demographics influencing market strategies [30][31]. Additional Considerations - The importance of biomarkers in identifying suitable patients for different therapies is highlighted, with ongoing research expected to refine patient selection [25][41]. - The need for collaboration between hematologists and rheumatologists is emphasized to facilitate patient enrollment in clinical trials [58][61]. This summary encapsulates the key points discussed during the conference call, providing insights into the current state and future potential of cell therapies in treating autoimmune diseases.