Core Insights - Cullinan Therapeutics (NASDAQ: CGEM) is a multifocal biotech company focused on precision medicine and immunotherapy [1] - The company has experienced a significant decline in market sentiment, with a drop of approximately 60% from its recent high over the past six months [1] Company Overview - Cullinan Therapeutics is engaged in various programs within the fields of precision medicine and immunotherapy [1] - The company aims to educate investors on the scientific aspects of its business and the importance of due diligence in biotech investments [1] Market Performance - The stock of Cullinan Therapeutics has faced a substantial downturn, reflecting negative market sentiment and investor concerns [1]

Clinical Trials and Drug Development - CLN-978 demonstrated a 10 times higher potency for B cell depletion compared to cytokine induction, indicating its potential advantages over other therapies[51] - In a Phase 1 trial for CLN-978, two out of three patients with relapsed/refractory B cell non-Hodgkin lymphoma experienced objective clinical benefits, including one complete response[51] - CLN-619 showed a clinical benefit rate of 41.4% in an ongoing Phase 1 trial, with one complete response and two partial responses observed[52] - Zipalertinib achieved a 40% objective response rate in patients with EGFRex20 NSCLC who had previously received systemic therapy[52] - The FDA granted Breakthrough Therapy designation to zipalertinib, which is co-developed with Taiho Pharmaceutical[52] - CLN-049 is currently in a Phase 1 trial for relapsed/refractory acute myeloid leukemia, with ongoing dose escalation following the discontinuation of subcutaneous administration due to injection site reactions[52] - CLN-617 is in a first-in-human Phase 1 trial for advanced solid tumors, with patient enrollment continuing[53] - The company plans to share initial clinical data for CLN-978 in Q4 2025 and initiate a clinical trial for rheumatoid arthritis in Q2 2025[51] - The pivotal Phase 2b portion of the REZILIENT1 trial for zipalertinib is expected to report results in mid-2025[52] Financial Performance - The company reported total operating expenses of $48.9 million for the three months ended September 30, 2024, compared to $44.8 million for the same period in 2023, representing an increase of 4.6%[63] - Research and development expenses for the three months ended September 30, 2024, were $35.5 million, up from $33.8 million in the same period in 2023, reflecting a $1.7 million increase[64] - The company incurred a net loss of $40.6 million for the three months ended September 30, 2024, compared to a net loss of $39.2 million for the same period in 2023[63] - The company reported a net cash used in operating activities of $108.7 million for the nine months ended September 30, 2024, compared to $116.1 million for the same period in 2023[67] - General and administrative expenses increased by $2.4 million in the three months ended September 30, 2024, compared to the same period in 2023, primarily due to higher professional fees and equity-based compensation costs[65] - For the nine months ended September 30, 2024, cash used in operating activities was $108.7 million, compared to $116.1 million for the same period in 2023, reflecting a decrease of approximately 6.0%[68] - Net cash used in investing activities for the nine months ended September 30, 2024, was $152.3 million, significantly higher than $15.7 million for the same period in 2023, indicating an increase of approximately 868.2%[69] - Net cash provided by financing activities for the nine months ended September 30, 2024, was $264.6 million, compared to $40.5 million in 2023, representing an increase of approximately 553.6%[69] Capital and Funding - As of September 30, 2024, the company has raised net proceeds of $842.2 million from equity financings and $275.0 million from the sale of equity interest in its zipalertinib development subsidiary to Taiho[57] - The company expects to continue generating operating losses for the foreseeable future, with an accumulated deficit of $320.6 million as of September 30, 2024[57] - The company has not generated any revenue from product sales since its inception and does not expect to do so in the near future[58] - The company completed a private placement in April 2024, raising net proceeds of $262.7 million after deducting offering costs of $17.3 million[66] - The company expects ongoing expenses to increase due to research and development activities, clinical trials, and regulatory approvals, which may lead to significant future funding requirements[70] - The company anticipates that current cash and investments will be sufficient to fund operations for at least twelve months from the date of the financial statements[70] - The company may require additional capital for in-licenses or acquisitions to expand its pipeline, depending on various operational factors[70] - The company may finance its cash needs through equity offerings, debt financings, and collaborations, which could dilute current ownership interests[71] Ownership and Interests - The company holds a 99% ownership interest in CLN-619, a 97% interest in CLN-049, and a 94% interest in CLN-617 as of September 30, 2024[56] - The company has certain payment obligations under license and collaboration agreements, contingent upon achieving specific milestones[72] Regulatory and Compliance - The company is classified as an "emerging growth company" and will cease this status as of December 31, 2024, which will require compliance with new accounting standards[73] - Total future minimum lease payments as of September 30, 2024, were $2.7 million, with $1.5 million payable within twelve months[72]

Financial Performance - Cullinan Therapeutics reported a net loss of $40.6 million ($0.69 per share) for Q3 2024, compared to a net loss of $39.2 million ($0.91 per share) in Q3 2023[8]. - Research and development expenses increased to $35.5 million in Q3 2024 from $33.8 million in Q3 2023, while general and administrative expenses rose to $13.3 million from $11.0 million in the same period[8]. - The company had a cash position of $639.0 million as of September 30, 2024, which is expected to provide runway into 2028 based on its current operating plan[8]. - Total assets increased to $653.3 million as of September 30, 2024, up from $484.2 million at the end of 2023[13]. Clinical Development - Cullinan has secured FDA clearance for its IND application and HREC approval in Australia to initiate a global Phase 1 study for CLN-978 in systemic lupus erythematosus, with initial clinical data expected in Q4 2025[1][2]. - The pivotal Phase 2b study of zipalertinib was completed ahead of schedule, with results anticipated in mid-2025[1][5]. - Initial expansion cohort data for CLN-619 in endometrial and cervical cancers is expected to be shared in Q2 2025[1][4]. - The company plans to initiate a sponsored clinical trial for rheumatoid arthritis in Q2 2025, collaborating with FAU Erlangen-Nuremberg and Università Cattolica del Sacro Cuore[3]. - Cullinan presented positive results for zipalertinib, showing an objective response rate of approximately 40% in patients with EGFR ex20ins NSCLC[5]. Strategic Initiatives - The company added two experts to its Scientific Advisory Board to strengthen its capabilities in rheumatology and immunology[7].

Core Insights - Cullinan Therapeutics, Inc. is participating in the Stifel 2024 Healthcare Conference, highlighting its focus on developing targeted therapies [1][2] Company Overview - Cullinan Therapeutics is a biopharmaceutical company dedicated to creating new standards of care for patients, with a diversified portfolio of clinical-stage assets targeting autoimmune diseases and cancer [3] - The company employs a modality-agnostic approach, aiming to develop transformative therapeutics by inhibiting key disease drivers or harnessing the immune system [3] - Cullinan's strategy includes rigorous candidate selection and development processes to fast-track promising molecules to clinical trials and commercialization [3]

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]