Cullinan Therapeutics, Inc. (CGEM) is a clinical-stage biopharmaceutical company dedicated to creating new standards of care for patients. The company has built a broad and deep pipeline of targeted immunology and oncology programs that includes multiple distinct clinical-stage product candidates. Cullinan's strategy is to identify high-impact targets and select the optimal therapeutic modality for those targets, with a focus on novel technology or differentiated mechanisms.
Business Overview and History Cullinan was incorporated in September 2016 and is headquartered in Cambridge, Massachusetts. The company was founded with the goal of developing innovative therapies to address unmet medical needs across various disease areas. In February 2023, Cullinan entered into a license and collaboration agreement with Harbour BioMed US Inc. to acquire an exclusive license for the development, manufacturing, and commercialization of HBM7008 (CLN-418) in the U.S. However, in August 2024, after reviewing data from the Phase 1 clinical trial, Cullinan notified Harbour of its decision to terminate the agreement, effectively discontinuing development of CLN-418.
One of Cullinan's key early milestones was the in-licensing of CLN-978, a novel CD19xCD3 bispecific T cell engager, in 2019. The company has been actively developing CLN-978 for the treatment of autoimmune diseases, such as systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA). In September 2024, Cullinan received Human Research Ethics Committee approval in Australia to initiate a global Phase 1 clinical trial evaluating CLN-978 in patients with SLE. Additionally, in October 2024, the company received clearance from the U.S. FDA for an investigational new drug (IND) application to evaluate CLN-978 in a Phase 1 trial in patients with moderate to severe SLE. Cullinan plans to initiate a sponsored clinical trial to evaluate CLN-978 in rheumatoid arthritis patients in 2025.
In the oncology space, Cullinan's lead unpartnered program is CLN-619, a monoclonal antibody that stabilizes the expression of MICA/B on the tumor cell surface to promote tumor cell lysis mediated by both cytotoxic innate and adaptive immune cells. In June 2024, the company presented preliminary clinical data from the combination dose escalation module of the ongoing Phase 1 trial, which demonstrated objective tumor responses across multiple tumor types, including non-small cell lung cancer (NSCLC) with oncogenic mutations. CLN-619 is being evaluated as both monotherapy and in combination with checkpoint inhibitor therapy or chemotherapy in an ongoing Phase 1 clinical trial in patients with advanced solid tumors.
Cullinan's pipeline also includes zipalertinib (CLN-081/TAS6417), an orally available, small-molecule, irreversible epidermal growth factor receptor (EGFR) inhibitor that selectively targets cells expressing EGFR exon 20 insertion mutations. The company is co-developing zipalertinib with Taiho Pharmaceutical, and the drug has received Breakthrough Therapy designation from the FDA. In September 2024, Cullinan announced updated data from the pivotal Phase 2b portion of the REZILIENT1 clinical trial, which showed a 40% objective response rate in patients with NSCLC harboring EGFR exon 20 insertion mutations who had received prior treatment with amivantamab.
The company is also developing CLN-49, a FLT3xCD3 T cell engaging bispecific antibody, in an ongoing Phase 1 trial in relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) patients. Additionally, Cullinan is evaluating CLN-617, a fusion protein combining IL-2 and IL-12 with tumor retention domains, in a first-in-human Phase 1 trial in advanced solid tumors.
Financials and Liquidity As of September 30, 2024, Cullinan had cash, cash equivalents, and short-term investments of $578.1 million, and long-term investments and interest receivable of $60.9 million. The company reported a net loss of $119.9 million for the nine months ended September 30, 2024, compared to a net loss of $129.5 million for the same period in 2023. Cullinan's research and development expenses for the nine months ended September 30, 2024, were $102.4 million, while its general and administrative expenses were $39.5 million.
For the most recent quarter (Q3 2024), Cullinan reported no revenue, a net loss of $40.56 million, operating cash flow of -$34.139 million, and free cash flow of -$34.139 million. The company does not generate revenue from product sales as it is still in the clinical stage of development.
For the fiscal year 2023, Cullinan reported a net loss of $153.162 million, operating cash flow of -$134.275 million, and free cash flow of -$134.483 million. The company's financial performance reflects its ongoing investments in research and development as it advances its pipeline of product candidates.
Cullinan's liquidity position remains strong, with a debt-to-equity ratio of 0.0039 as of September 30, 2024. The company's current ratio and quick ratio both stand at 24.46, indicating a robust ability to meet short-term obligations. Cullinan does not have any disclosed available credit lines.
The company's cash runway, based on its current operational plans and assumptions, is expected to fund operations through at least the next twelve months from the date of issuance of the consolidated financial statements. Cullinan has a history of funding its operations primarily through the sale of equity securities and from licensing or selling the rights to its product candidates.
Recent Developments and Outlook In April 2024, Cullinan completed a private placement, raising net proceeds of $262.7 million. The company also has an at-the-market equity offering program in place, through which it has sold approximately 3.3 million shares and received net proceeds of $38.4 million as of September 30, 2024.
Cullinan's key upcoming milestones include - Initiating the global Phase 1 clinical trial of CLN-978 in patients with SLE in the U.S. and Australia, with initial data expected in Q4 2025 - Reporting initial data from the disease-specific expansion cohorts for CLN-619 in endometrial and cervical cancers in Q2 2025 - Sharing results of the pivotal Phase 2b portion of the REZILIENT1 clinical trial for zipalertinib in mid-2025
Risks and Challenges As a clinical-stage biopharmaceutical company, Cullinan faces several risks and challenges common to the industry, including - Successful development and regulatory approval of its product candidates - Ability to manage clinical trial timelines and costs - Potential competition from other therapies targeting similar disease pathways - Reliance on third-party vendors for manufacturing and clinical trial operations - Ability to secure additional funding to support ongoing and future development activities
The company's broad and diversified pipeline, along with its strong cash position, position it well to navigate these challenges and continue advancing its strategic priorities. Cullinan's focus on identifying high-impact targets and selecting the optimal therapeutic modality has the potential to yield novel therapies that can address significant unmet medical needs across autoimmune diseases and oncology.
Conclusion Cullinan Therapeutics has built an impressive pipeline of targeted immunology and oncology programs, with multiple distinct clinical-stage product candidates. The company's strategic approach of identifying high-impact targets and selecting the optimal therapeutic modality has yielded promising results, as evidenced by the clinical data and upcoming milestones for its lead programs, CLN-978, CLN-619, and zipalertinib. With a strong cash position and a diversified portfolio, Cullinan is well-positioned to continue its pursuit of developing innovative therapies that can improve the standard of care for patients. The company's focus on both immunology and oncology, with no approved products for sale yet, underscores its commitment to addressing unmet medical needs across multiple therapeutic areas. As Cullinan advances its pipeline and approaches key clinical readouts, investors and industry observers will be closely watching the progress of its innovative therapies in addressing complex diseases.