Core Viewpoint - Cullinan Therapeutics has received FDA clearance for its Investigational New Drug application for CLN-978, marking it as the first CD19 T cell engager in development for autoimmune diseases, specifically targeting systemic lupus erythematosus (SLE) [1][4]. Group 1: Clinical Trial Details - The global Phase 1 clinical trial will assess CLN-978 in patients with moderate to severe SLE, specifically those with a Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score of eight or greater and who have not responded adequately to at least two prior treatments [2]. - The trial consists of two parts: Part A is a dose escalation phase starting at 10 micrograms to determine the target dose, while Part B will explore multiple dose schedules based on data from Part A [2]. Group 2: Objectives and Mechanism - The primary objective of the study is to evaluate the safety of CLN-978 for treating active moderate to severe SLE, with secondary objectives including pharmacokinetics, B cell kinetics, immunogenicity, and clinical activity [3]. - CLN-978 is a bispecific T cell engager designed to target CD19, facilitating the lysis of CD19-expressing cells, and is engineered for high affinity binding to efficiently target B cells, including those with low CD19 levels [5]. Group 3: Market Need and Company Background - There is a significant unmet medical need for effective treatments in SLE, as current therapies often fail to control disease activity and prevent long-term organ damage [4]. - Cullinan Therapeutics is focused on developing targeted therapies across various modalities for autoimmune diseases and cancer, aiming to create new standards of care [7].

Core Insights - Updated data indicates a consistent objective response rate (ORR) of 40% and a manageable safety profile for zipalertinib in patients with non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations who have progressed after prior amivantamab treatment [1][4] - The pivotal Phase 2b trial has completed enrollment ahead of schedule, originally planned for the end of 2024 [5] Clinical Trial Data - As of March 29, 2024, 45 patients were enrolled, with a median of three prior systemic anti-cancer regimens received [2] - Among 30 evaluable patients, 1 patient (3%) achieved a complete response (CR), 11 patients (37%) had a partial response (PR), and 15 patients (50%) had stable disease (SD) [3] - The confirmed ORR for Module C was 40%, compared to 41% in the previously reported Phase 1/2a results [4] Safety Profile - Zipalertinib demonstrated a manageable safety profile, with the most common treatment-related adverse events being rash (38%), paronychia (36%), anemia (24%), dry skin (20%), dermatitis acneiform (16%), nausea (16%), and stomatitis (11%) [4] Company and Product Overview - Zipalertinib is an orally available small molecule designed to target activating mutations in EGFR, specifically engineered to inhibit EGFR variants with exon 20 insertion mutations while sparing wild-type EGFR [8] - Cullinan Therapeutics has a partnership with Taiho, which includes an upfront cash payment of $275 million and potential additional payments totaling $130 million for U.S. regulatory milestones [7] - The company retains a 50/50 profit share in the U.S. for zipalertinib [7] Future Development - Cullinan and Taiho have a broad development program for zipalertinib, including ongoing pivotal studies in first-line and second-line NSCLC, as well as studies in other patient populations [6]

Core Insights - Cullinan Therapeutics, Inc. is actively participating in investor conferences to enhance visibility and engagement with stakeholders [1][2] Company Overview - Cullinan Therapeutics, Inc. (Nasdaq: CGEM) is a biopharmaceutical company focused on developing targeted therapies that are modality-agnostic [3] - The company has built a diversified portfolio of clinical-stage assets aimed at inhibiting key disease drivers and harnessing the immune system for treating autoimmune diseases and cancer [3] - Cullinan's approach includes rigorous candidate selection and development processes to fast-track promising therapeutic molecules [3] Upcoming Events - The CEO and CMO of Cullinan will participate in a fireside chat at the Morgan Stanley 22nd Annual Global Healthcare Conference on September 5, 2024 [1] - Additionally, they will engage in a fireside chat at the 2024 Cantor Global Healthcare Conference on September 19, 2024 [2] - Webcasts of these events will be available on the company's investor relations website [2]

Financial Position - The company has received net proceeds of $842.2 million from equity financings as of June 30, 2024[48]. - As of June 30, 2024, the company had cash, cash equivalents, and short-term investments totaling $664.9 million[48]. - Net cash used in operating activities for the first half of 2024 was $74.5 million, an improvement from $82.0 million in the same period of 2023[56]. - Net cash provided by financing activities in the first half of 2024 was $263.3 million, significantly higher than $40.4 million in the same period of 2023, primarily due to a private placement[56]. - The company completed a private placement in April 2024, raising $262.7 million after deducting offering costs[55]. - The company has sold approximately 3.3 million shares under its at-the-market equity offering program, receiving net proceeds of $38.4 million as of June 30, 2024[55]. - As of June 30, 2024, total future minimum lease payments were $3.0 million, with $1.4 million payable within twelve months[61]. - The market value of the company's common stock held by non-affiliates exceeded $700 million as of June 30, 2024[62]. Operating Losses and Deficits - The company reported an accumulated deficit of $280.0 million as of June 30, 2024, and expects to continue generating operating losses for the foreseeable future[48]. - The company has not generated any revenue from product sales since inception and does not expect to do so in the near future[49]. - The company has not yet commercialized any products and does not expect to generate revenue from product sales for several years[55]. - Net loss for Q2 2024 was $42.0 million, compared to a net loss of $32.2 million in Q2 2023, reflecting a 30% increase in losses[55]. Research and Development - The company plans to submit an IND application for CLN-978 in patients with systemic lupus erythematosus in Q3 2024[46]. - Preliminary clinical data for CLN-619 showed a clinical benefit rate of 41.4% across multiple tumor types, with one complete response and two partial responses observed[47]. - The ongoing Phase 1 clinical trial of CLN-049 is investigating its use in relapsed/refractory acute myeloid leukemia and myelodysplastic syndrome[47]. - Research and development expenses for Q2 2024 increased by $8.9 million (24%) to $36.3 million compared to Q2 2023, driven by higher clinical, CMC, and preclinical costs[55]. Expenses and Future Funding - General and administrative expenses for Q2 2024 rose by $3.6 million (35%) to $13.8 million compared to Q2 2023, primarily due to increased equity-based compensation and personnel costs[55]. - The company expects ongoing increases in expenses related to clinical trials, manufacturing, and public company operations, necessitating potential future funding[59]. - The company expects to finance cash needs through equity offerings, debt financings, and collaborations, which may dilute current ownership interests[60]. - The company is unable to estimate exact working capital requirements due to numerous risks and uncertainties associated with research, development, and commercialization of product candidates[60]. Licensing and Collaboration Agreements - The company terminated the Harbour License Agreement for CLN-418, effective November 2024, and will discontinue its development[44]. - The company has certain payment obligations under license and collaboration agreements, contingent upon achieving specified development, clinical, regulatory, and commercial milestones[61]. - The company may have to relinquish valuable rights to technologies or future revenue streams if additional funds are raised through collaborations or licensing arrangements[60]. Regulatory and Compliance - The company qualifies as an "emerging growth company" and will cease this status as of December 31, 2024, requiring the adoption of all new accounting pronouncements[62]. - The company is subject to new requirements under the Sarbanes-Oxley Act due to its status change from an emerging growth company[62]. - Recently issued accounting pronouncements that may impact financial position and results of operations are disclosed in the quarterly report[63]. - The company has not materially changed its critical accounting policies from those described in the 2023 10-K[61].

[Corporate Update and Q2 2024 Highlights](index=1&type=section&id=Corporate%20Update%20and%20Q2%202024%20Highlights) This section provides an overview of corporate strategic advancements and key highlights from Q2 **2024** [Strategic Focus and Pipeline Advancement](index=1&type=section&id=Strategic%20Focus%20and%20Pipeline%20Advancement) Cullinan Therapeutics expands into autoimmune diseases, advances oncology pipeline, prioritizes CLN-978, and discontinues CLN-418 development - The company is expanding its focus into autoimmune diseases, alongside its existing oncology pipeline[1](index=1&type=chunk) - An Investigational New Drug (IND) application for CLN-978 in systemic lupus erythematosus (SLE) is on track to be filed in the third quarter of **2024**[1](index=1&type=chunk) - Rheumatoid arthritis (RA) will be pursued as the second autoimmune indication for CLN-978[1](index=1&type=chunk) - To focus resources on the most promising programs, the company will discontinue the development of CLN-418[1](index=1&type=chunk)[5](index=5&type=chunk) [Portfolio Highlights](index=2&type=section&id=Portfolio%20Highlights) The company provided key clinical pipeline updates, advancing immunology and oncology programs while discontinuing CLN-418 [Immunology: CLN-978](index=2&type=section&id=Immunology%3A%20CLN-978) CLN-978 is on track for an SLE IND submission in Q3 **2024**, with plans to expand into Rheumatoid Arthritis - Remains on track to submit an IND application for the global SLE study to the FDA in Q3 **2024**[2](index=2&type=chunk) - Plans to explore CLN-978 in rheumatoid arthritis (RA) as its second autoimmune indication[2](index=2&type=chunk) - Will collaborate with FAU Erlangen-Nuremberg and Università Cattolica del Sacro Cuore, Rome to conduct a clinical trial in RA[2](index=2&type=chunk) [Oncology Pipeline](index=2&type=section&id=Oncology%20Pipeline) The oncology pipeline advanced with positive clinical data for key assets, a route change for CLN-049, and CLN-418 discontinuation - CLN-619: Combination therapy data demonstrated objective responses in non-small cell lung cancer (NSCLC) with oncogenic mutations[3](index=3&type=chunk) - Zipalertinib: Announced positive initial data from the pivotal Phase 2b portion of the REZILIENT1 study in patients with EGFR ex20ins NSCLC[3](index=3&type=chunk) - CLN-049: Dose escalation is now continuing with IV administration in the Phase 1 study due to dose-limiting injection site reactions with subcutaneous administration[4](index=4&type=chunk) - CLN-418: Cullinan plans to discontinue development and will return development and commercial rights to Harbour BioMed[5](index=5&type=chunk) [Corporate Updates](index=3&type=section&id=Corporate%20Updates) The company strengthened its financial position with a **$280 million** private placement and enhanced board leadership - In April, the company completed an oversubscribed private placement of common stock, grossing **$280 million**[6](index=6&type=chunk) - In August, Mary Thistle was appointed to the Board of Directors, bringing thirty years of operational and business development expertise[6](index=6&type=chunk) [Second Quarter 2024 Financial Results](index=3&type=section&id=Second%20Quarter%202024%20Financial%20Results) This section details the company's financial performance and position for the second quarter of **2024** [Financial Position](index=3&type=section&id=Financial%20Position) Cullinan Therapeutics reported a strong cash position of **$664.9 million** as of June 30, **2024**, with a financial runway extending into **2028** Cash Position | Metric | June 30, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Cash, cash equivalents, investments, and interest receivable | $664.9 million | $468.3 million | - The company expects its cash resources to provide runway into **2028**[7](index=7&type=chunk) [Operating Expenses](index=4&type=section&id=Operating%20Expenses) Operating expenses increased in Q2 **2024** due to higher R&D and G&A costs, with year-to-date R&D decreasing from a prior-year fee Research & Development (R&D) Expenses (in millions) | Period | Q2 2024 | Q2 2023 | YTD 2024 | YTD 2023 | | :--- | :--- | :--- | :--- | :--- | | R&D Expenses | $36.3 | $27.4 | $66.9 | $79.5 | - The increase in Q2 R&D expenses was primarily related to increases in clinical costs, chemistry, manufacturing and controls costs, preclinical costs, and personnel costs[8](index=8&type=chunk) General & Administrative (G&A) Expenses (in millions) | Period | Q2 2024 | Q2 2023 | YTD 2024 | YTD 2023 | | :--- | :--- | :--- | :--- | :--- | | G&A Expenses | $13.8 | $10.2 | $26.1 | $20.9 | - The increase in G&A expenses was primarily driven by increased personnel costs relating to additional headcount[8](index=8&type=chunk) [Net Loss](index=4&type=section&id=Net%20Loss) Net loss increased to **$42.0 million** in Q2 **2024** due to higher operating expenses, but decreased year-to-date to **$79.4 million** Net Loss Summary (in millions, except per share data) | Period | Q2 2024 | Q2 2023 | YTD 2024 | YTD 2023 | | :--- | :--- | :--- | :--- | :--- | | Net Loss | $42.0 | $32.2 | $79.4 | $90.4 | | Net Loss per Share | $(0.75) | $(0.82) | $(1.61) | $(2.24) | - Net losses were partially offset by interest income of **$8.1 million** in Q2 **2024** and **$13.8 million** in the first six months of **2024**[8](index=8&type=chunk) [Shares Outstanding](index=4&type=section&id=Shares%20Outstanding) As of July 31, **2024**, Cullinan Therapeutics had approximately **58.0 million shares** of common stock outstanding, including convertible instruments - As of July 31, **2024**, Cullinan had **57,976,641 shares** of common stock outstanding[9](index=9&type=chunk) - Additionally, there were pre-funded warrants convertible into **315,790 shares** and non-voting preferred stock convertible into **6,475,000 shares**[9](index=9&type=chunk) [Financial Statements](index=7&type=section&id=Financial%20Statements) This section presents the company's condensed consolidated balance sheet and statements of operations [Selected Condensed Consolidated Balance Sheet Data](index=7&type=section&id=Selected%20Condensed%20Consolidated%20Balance%20Sheet%20Data) This section provides a snapshot of the company's financial position as of June 30, **2024**, compared to December 31, **2023**, detailing key assets, liabilities, and stockholders' equity Condensed Consolidated Balance Sheet Data (unaudited, in thousands) | | June 30, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Cash, cash equivalents, investments, and interest receivable | $664,943 | $468,264 | | Total assets | $681,216 | $484,182 | | Total current liabilities | $23,476 | $28,137 | | Total liabilities | $24,995 | $30,287 | | Total stockholders' equity | $656,221 | $453,895 | [Consolidated Statements of Operations](index=8&type=section&id=Consolidated%20Statements%20of%20Operations) This section presents the company's operational performance for the three and six months ended June 30, **2024**, and **2023**, outlining operating expenses, other income, and the resulting net loss Consolidated Statements of Operations (unaudited, in thousands, except per share amounts) | | Three Months Ended June 30, 2024 | Three Months Ended June 30, 2023 | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $36,259 | $27,391 | $66,905 | $79,487 | | General and administrative | $13,768 | $10,214 | $26,111 | $20,874 | | **Total operating expenses** | **$50,027** | **$37,605** | **$93,016** | **$100,361** | | Loss from operations | $(50,027) | $(37,605) | $(93,016) | $(100,361) | | Interest income | $8,071 | $5,322 | $13,764 | $9,830 | | **Net loss** | **$(42,028)** | **$(32,214)** | **$(79,368)** | **$(90,355)** | | Net loss per share | $(0.75) | $(0.82) | $(1.61) | $(2.24) |

Core Insights - Cullinan Therapeutics announced positive initial data for zipalertinib in patients previously treated with amivantamab in the pivotal Phase 2b REZILIENT1 clinical trial [1][4] - The drug demonstrated promising efficacy and a manageable safety profile, comparable to results seen in patients who progressed after platinum-based chemotherapy [4][5] Patient Data and Efficacy - As of January 12, 2024, 31 patients were enrolled, with a median of three prior systemic anti-cancer regimens [2] - Among 18 evaluable patients, the objective response rate (ORR) was 39%, and the disease control rate (DCR) was 94%, similar to the Phase 1/2a results where ORR was 41% and DCR was 97% [3] Safety Profile - Zipalertinib exhibited a manageable safety profile, with no grade 4 or grade 5 treatment-related adverse events reported [3] Development and Partnerships - The company has a comprehensive development plan for zipalertinib, which includes ongoing pivotal studies in first-line and second-line treatment for non-small cell lung cancer (NSCLC) [4][5] - Cullinan entered a partnership with Taiho in 2022, involving an upfront payment of $275 million and additional payments totaling $130 million for regulatory approvals in the U.S. [4] Future Plans - Enrollment for the pivotal Phase 1/2b REZILIENT1 trial is expected to be completed by the end of 2024 [5] - An investor event is scheduled to present the zipalertinib data, indicating ongoing engagement with stakeholders [6][7]

CAMBRIDGE, Mass., May 24, 2024 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (NASDAQ:CGEM), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today announced that Nadim Ahmed, Chief Executive Officer and Jeffrey Jones, MD, MBA, Chief Medical Officer, will participate in a fireside chat at the TD Cowen 5th Annual Oncology Innovation Summit: Insights for ASCO & EHA, being held virtually on May 28 and 29, 2024. The fireside chat is scheduled for Wednesday, May 29, 2024 a ...

Preliminary data from CLN-619 in combination with checkpoint inhibitor pembrolizumab show objective responses in patients with tumor types that are typically unresponsive to pembrolizumab, such as non-small cell lung cancer (NSCLC) with oncogenic mutations Longer term follow-up for patients treated with CLN-619 monotherapy demonstrates durable clinical benefit across multiple tumor types CLN-619 continues to demonstrate a favorable safety profile and is well tolerated both as monotherapy and in combination ...

Net Loss Attributable to Noncontrolling Interests Net loss attributable to noncontrolling interests is determined as the difference in the noncontrolling interests in the consolidated balance sheets between the start and end of each reporting period, after taking into account any capital transactions between our development subsidiaries and third parties. 14 Liquidity and Capital Resources Overview We have a history of significant operating losses and have had negative cash flows from operations since our i ...

[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 |