[Portfolio Highlights](index=1&type=section&id=Portfolio%20Highlights) Cullinan Therapeutics provided updates on its clinical portfolio, including a strategic shift for CLN-978 to autoimmune diseases and key milestones for CLN-619 and Zipalertinib [CLN-619 (Anti-MICA/MICB monoclonal antibody)](index=1&type=section&id=CLN-619%20(Anti-MICA%2FMICB%20monoclonal%20antibody)) Initial combination and monotherapy dose escalation data for CLN-619 will be presented at ASCO 2024, with disease-specific expansion cohort data expected in H1 2025 - Initial combination and updated monotherapy dose escalation data will be presented in a poster session at the ASCO Annual Meeting on June 1, 2024[21](index=21&type=chunk) - The company remains on track to report initial data from disease-specific dose expansion cohorts in the first half of 2025[21](index=21&type=chunk) [CLN-978 (CD19xCD3 T cell engager)](index=1&type=section&id=CLN-978%20(CD19xCD3%20T%20cell%20engager)) CLN-978 development now focuses exclusively on autoimmune diseases, with SLE as the initial indication, following positive B-NHL study observations and planned Q3 2024 IND submission - Development focus has shifted exclusively to autoimmune diseases, with SLE as the initial indication[20](index=20&type=chunk)[23](index=23&type=chunk)[27](index=27&type=chunk) - An IND application for SLE is planned for submission in the third quarter of 2024[23](index=23&type=chunk) - Enrollment in the B-cell non-Hodgkin lymphoma (B-NHL) study has been discontinued to prioritize development in autoimmune diseases[23](index=23&type=chunk) - Recent clinical observations in the B-NHL study showed CLN-978 is clinically active with a favorable safety profile at its initial dose[22](index=22&type=chunk) [Zipalertinib (EGFR ex20ins inhibitor)](index=2&type=section&id=Zipalertinib%20(EGFR%20ex20ins%20inhibitor)) Cullinan expects to complete enrollment in the pivotal Phase 2b REZILIENT1 study for EGFR ex20ins NSCLC by year-end 2024 - Enrollment in the pivotal Phase 2b REZILIENT1 study is expected to be completed by year-end 2024[1](index=1&type=chunk) [Other Pipeline Programs](index=2&type=section&id=Other%20Pipeline%20Programs) Clinical data updates for CLN-049 in AML/MDS and CLN-418 in solid tumors are expected in H2 2024, with ongoing enrollment for CLN-617 Phase 1 study - A clinical data update for CLN-049 (FLT3xCD3) in r/r AML and MDS patients is expected in the second half of 2024[2](index=2&type=chunk)[16](index=16&type=chunk) - A clinical data update for CLN-418 (B7H4x4-1BB) from the Phase 1 dose escalation study in advanced solid tumors is expected in the second half of 2024[5](index=5&type=chunk)[16](index=16&type=chunk) - Enrollment continues in the ongoing Phase 1 study of CLN-617 (IL-2 and IL-12 cytokine fusion protein) in patients with advanced solid tumors[6](index=6&type=chunk) [Corporate Updates](index=3&type=section&id=Corporate%20Updates) Cullinan announced key leadership appointments, a strategic expansion into autoimmune diseases with a name change, and strengthened its financial position via a **$280 million** private placement - David Meek was appointed to the Board of Directors, effective May 15[7](index=7&type=chunk) - In April, the company appointed Mary Kay Fenton as Chief Financial Officer[9](index=9&type=chunk) - The company announced its strategic expansion into autoimmune diseases and changed its name to Cullinan Therapeutics[7](index=7&type=chunk) - Completed an oversubscribed **$280 million** private placement sale of common stock in April[8](index=8&type=chunk) [First Quarter 2024 Financial Results](index=3&type=section&id=First%20Quarter%202024%20Financial%20Results) Cullinan reported a Q1 2024 net loss of **$37.3 million**, an improvement from Q1 2023, driven by lower R&D expenses, ending with **$434.8 million** cash and an extended runway into 2028 - Cash, cash equivalents, investments, and interest receivable were **$434.8 million** as of March 31, 2024[10](index=10&type=chunk) - The company expects its cash resources to provide runway into 2028, bolstered by the April 2024 private placement[10](index=10&type=chunk)[25](index=25&type=chunk) Key Financial Metrics | Metric | Q1 2024 ($M) | Q1 2023 ($M) | Key Driver of Change | | :--- | :--- | :--- | :--- | | R&D Expenses | $30.6 | $52.1 | Decrease primarily due to a one-time upfront in-licensing fee in 2023 | | G&A Expenses | $12.3 | $10.7 | Increase driven by personnel costs and non-cash equity-based compensation | | Net Loss | $37.3 | $58.1 | Reduction driven by lower R&D expenses | [Consolidated Statements of Operations](index=7&type=section&id=Consolidated%20Statements%20of%20Operations) The company reported a Q1 2024 net loss of **$37.1 million** or **($0.86)** per share, an improvement from Q1 2023, primarily due to reduced research and development expenses | (in thousands, except per share amounts) | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Research and development | $30,646 | $52,096 | | General and administrative | $12,343 | $10,660 | | **Total operating expenses** | **$42,989** | **$62,756** | | **Loss from operations** | **($42,989)** | **($62,756)** | | Interest income | $5,693 | $4,508 | | **Net loss** | **($37,340)** | **($58,141)** | | Net loss per share (Basic and diluted) | ($0.86) | ($1.42) | [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2024, Cullinan Therapeutics reported total assets of **$449.4 million**, total stockholders' equity of **$425.7 million**, and **$434.8 million** in cash, equivalents, investments, and interest receivable | (in thousands) | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Cash, cash equivalents, investments, and interest receivable | $434,827 | $468,264 | | Total assets | $449,430 | $484,182 | | Total liabilities | $23,765 | $30,287 | | Total stockholders' equity | $425,665 | $453,895 |

CAMBRIDGE, Mass., April 29, 2024 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (NASDAQ:CGEM), a biopharmaceutical company focused on modality-agnostic targeted therapies, today announced the appointment of Mary Kay Fenton as Chief Financial Officer, beginning April 29. "I am pleased to welcome Mary Kay to Cullinan Therapeutics as Chief Financial Officer. This is a pivotal time for Cullinan as we expand into autoimmune diseases and continue to advance our clinical-stage oncology portfolio," said Nadim Ahme ...

CAMBRIDGE, Mass., April 24, 2024 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (NASDAQ:CGEM), a biopharmaceutical company focused on modality-agnostic targeted therapies, today announced that clinical data from its Phase 1 trial of CLN-619 in patients with advanced solid tumors will be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting taking place in Chicago from May 31-June 4, 2024. The data will include first results from the dose escalation cohort of CLN-619 in combinati ...

CAMBRIDGE, Mass., April 24, 2024 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on modality-agnostic targeted therapies, today announced that clinical data from its Phase 1 trial of CLN-619 in patients with advanced solid tumors will be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting taking place in Chicago from May 31-June 4, 2024. The data will include first results from the dose escalation cohort of CLN-619 in combinat ...

CLN-978 clinical development to focus exclusively on autoimmune diseases, pursuing systemic lupus erythematosus as a first indication Clinical observations from CLN-978 B-NHL study show rapid, deep, and sustained B cell depletion and clinical activity Corporate name change to Cullinan Therapeutics reflects strategic expansion into autoimmune diseases Cullinan Therapeutics to host a virtual investor event taking place on April 16 at 8:00 am ET CAMBRIDGE, Mass., April 16, 2024 (GLOBE NEWSWIRE) -- Cullinan Th ...

PART III Item 10. Directors, Executive Officers and Corporate Governance 115 Item 11. Executive Compensation 118 Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 125 Item 13. Certain Relationships and Related Transactions, and Director Independence 129 Item 14. Principal Accountant Fees and Services 131 Unless otherwise stated or the context indicates otherwise, all references herein to "Cullinan," "Cullinan Oncology, Inc.," "we," "us," "our," "our comp ...

Cullinan remains on track to report additional solid tumor dose escalation data for CLN-619 in the second quarter of 2024 and recently received FDA clearance for an IND to evaluate CLN-619 in relapsed/refractory multiple myeloma CAMBRIDGE, Mass., March 14, 2024 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (Nasdaq: CGEM; "Cullinan"), a biopharmaceutical company focused on developing modality-agnostic targeted oncology therapies, today reported on recent and upcoming business highlights and announced its finan ...

Company will initiate Phase 1 study of CLN-619 for relapsed or refractory multiple myeloma, first MICA/B antibody clinical study in hematologic malignancies Follows ongoing clinical study of CLN-619 alone and in combination with pembrolizumab in solid tumors, with anticipated updated clinical data in Q2 2024 CAMBRIDGE, Mass., March 01, 2024 (GLOBE NEWSWIRE) -- Cullinan Oncology, Inc. (NASDAQ:CGEM), a biopharmaceutical company focused on modality-agnostic targeted oncology therapies, today announced the U.S ...

Financial Position - As of September 30, 2023, the company had cash, cash equivalents, and short-term investments totaling $466.4 million, with long-term investments and interest receivable of $15.5 million[66]. - The company has incurred significant operating losses since inception, with an accumulated deficit of $177.1 million as of September 30, 2023[66]. - The company expects its current cash resources to fund operations for at least twelve months from the date of the financial statements[91]. - Net cash used in operating activities for the nine months ended September 30, 2023, was $116.1 million, compared to $101.7 million for the same period in 2022, indicating a 14.3% increase in cash outflow[84]. - Cash, cash equivalents, and short-term investments as of September 30, 2023, totaled $466.4 million, with long-term investments and interest receivable of $15.5 million[83]. - Net cash provided by financing activities for the nine months ended September 30, 2023, was $40.5 million, mainly from $38.4 million in net proceeds from the issuance of common stock under the ATM[93]. - As of September 30, 2023, total future minimum lease payments were $4.6 million, with $1.9 million payable within twelve months[96]. Revenue and Financing - The company has not generated any revenue from product sales since inception and does not expect to do so in the near future[71]. - The company has received net proceeds of $579.6 million from equity financings and $275.0 million from the sale of its equity interest in Cullinan Pearl Corp. to Taiho in June 2022[66]. - The company expects to finance cash needs through equity offerings, debt financings, and collaborations until product revenue is sufficient for profitability[95]. - The company sold approximately 3.3 million shares under its at-the-market equity offering program, receiving net proceeds of $38.4 million in the nine months ended September 30, 2023[91]. Operating Expenses - Total operating expenses for the three months ended September 30, 2023, were $44.8 million, compared to $29.8 million for the same period in 2022, representing a 50.5% increase[78]. - Research and development expenses increased to $33.8 million for the three months ended September 30, 2023, from $19.7 million in the same period in 2022, a 71.8% increase[79]. - The company expects expenses to continue increasing due to ongoing activities, particularly in clinical trials and manufacturing of product candidates, as well as costs associated with operating as a public company[94]. Research and Development - The lead program, CLN-619, demonstrated anti-tumor activity in heavily pre-treated patients, with one confirmed complete response and two confirmed partial responses among 22 evaluable patients[65]. - Zipalertinib has received Breakthrough Therapy designation from the FDA and is being evaluated in pivotal trials for EGFRex20 non-small-cell lung cancer[65]. - Initial clinical data for CLN-418 is expected in the second half of 2024, while the first patient for CLN-617 is anticipated to be dosed by year-end 2023[66]. - The company holds worldwide development and commercialization rights to several product candidates, including CLN-619, CLN-049, CLN-978, and CLN-617[66]. - The company expects to continue generating operating losses for the foreseeable future, dependent on the success of its research and development efforts[66]. - Future funding requirements may increase significantly based on factors such as the scope and progress of drug discovery and clinical development, timely completion of studies, and the ability to establish collaborations[95]. Other Financial Information - Net loss attributable to common stockholders for the three months ended September 30, 2023, was $39.2 million, compared to a loss of $24.8 million in the same period in 2022, reflecting a 58.1% increase in losses[78]. - Other income increased by $13.1 million for the nine months ended September 30, 2023, primarily due to higher investment income[88]. - Impairment of long-lived assets was recorded at $(440,000) for the three months ended September 30, 2023, with no impairment recorded in the same period in 2022[78]. - For the nine months ended September 30, 2023, net cash used by investing activities was $15.7 million, primarily due to $307.4 million in purchases of marketable securities, partially offset by $291.9 million in proceeds from sales and maturities of marketable securities[93]. Capital Requirements - The company may require additional capital to pursue in-licenses or acquisitions to expand its pipeline[94]. - The company has certain payment obligations under various license and collaboration agreements, which are contingent upon achieving specific milestones[96]. - The company has adopted a blended rate for expected stock price volatility in the Black-Scholes option pricing model, combining its historical volatility with that of similar entities[98]. - The company remains an emerging growth company and has elected to use the extended transition period for new accounting standards[100].

There is a compelling biological and clinical rationale for targeting • 10 mg/kg: 1 ovarian (ongoing after 3 cycles), 1 cervical (ongoing after 6 cycles) 0 10 20 30 0 Stu y Duration ( eeks) MICA-NKG2D Binding in Presence of CLN-619 Abs References 1. Chihara et al. Lancet 2022. 2. Papadopoulos et al. ASCO 2019. 3. Bendell et al. AACR 2020. 4. Patients who underwent at least one RECIST response assessment or who had clinically assessed PD prior to first planned assessment 5. Endometrial, cervical, and ovarian ...