On November 8, 2023 Cullinan Oncology, Inc. (Nasdaq: CGEM; "Cullinan") a biopharmaceutical company focused on modality-agnostic targeted oncology therapies, reported on recent and upcoming business highlights and announced its financial results for the third quarter ended September 30, 2023 (Press release, Cullinan Oncology, NOV 8, 2023, View Source [SID1234637254]).

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"We have made tremendous strides through the first three quarters of 2023, while positioning Cullinan for a data-rich 2024," said Nadim Ahmed, Chief Executive Officer of Cullinan Oncology. "We are rapidly progressing CLN-619 and look forward to providing initial data from the combination therapy module, as well as additional monotherapy data, from the Phase 1 dose escalation study in the second quarter of 2024. We also expect to provide initial data from our disease-specific expansion cohorts in the first half of 2025. Our broad zipalertinib development program, being conducted in collaboration with our partners at Taiho, is also continuing, and we expect to complete enrollment in the pivotal Phase 2b portion of the REZILIENT1 study by the end of 2024. We expect to present data for CLN-049 and CLN-418 in the second half of 2024 as well. We finished Q3 with cash and investments of $482 million, which we now expect to provide runway into the second half of 2026, two quarters beyond previous guidance."

Portfolio Highlights

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CLN-619 (Anti-MICA/MICB monoclonal antibody): Solid tumors
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Enrollment continues in the ongoing Phase 1 study evaluating CLN-619 as both monotherapy and in combination with checkpoint inhibitor therapy. Accrual to the dose escalation phase of the combination module has been completed. Recruitment continues to the monotherapy disease specific expansion cohorts for patients with endometrial and cervical cancers. Cullinan also continues to evaluate additional disease specific expansion cohorts.

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At the 2023 SITC (Free SITC Whitepaper) Annual Meeting, initial biomarker data from the ongoing Phase 1 study of CLN-619 were presented at a poster session, providing evidence for CLN-619’s mechanism of action and demonstrating that clinical activity, including objective response, has been observed in patients with tumor characteristics not typically responsive to checkpoint inhibitor therapy.

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Zipalertinib (EGFR ex20ins inhibitor): EGFR ex20ins NSCLC
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In August 2023, Cullinan Oncology, in collaboration with our partners at Taiho Oncology, Inc., announced the initiation of REZILIENT3, a global Phase 3 study evaluating zipalertinib plus chemotherapy versus chemotherapy alone in patients with EGFR exon 20 insertion mutation non-small-cell lung cancer (EGFR ex20ins NSCLC) in the first-line setting.
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Enrollment continues in the pivotal Phase 2b portion of the REZILIENT1 study, evaluating zipalertinib in a cohort of patients with EGFR ex20ins NSCLC who have progressed after prior systemic therapy, as well as in a separate cohort of patients progressing after prior treatment with a currently approved agent for EGFR ex20ins NSCLC.
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CLN-049 (FLT3xCD3 T cell-engaging bispecific antibody): AML and MDS
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Enrollment continues in the ongoing Phase 1 multi-ascending dose study using subcutaneous administration.
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CLN-418 (B7H4x4-1BB bispecific immune activator): Solid tumors
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Preclinical data, including target expression profiling data and robust anti-tumor activity supporting the development of CLN-418 in multiple solid tumors, were presented at the 2023 SITC (Free SITC Whitepaper) Annual Meeting.
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Enrollment continued in the ongoing Phase 1 dose escalation study in patients with advanced solid tumors.
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CLN-978 (CD19xCD3 T cell engager): B-NHL
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In August 2023, Cullinan dosed the first patient in a Phase 1 study of CLN-978 in patients with R/R B-NHL.
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Preclinical data demonstrating the effectiveness of CLN-978 against lymphoma cells expressing very low levels of CD19 were presented at the 2023 SITC (Free SITC Whitepaper) Annual Meeting.
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CLN-617 (IL-2 and IL-12 cytokine fusion protein): Solid tumors
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Cullinan anticipates dosing the first patient in the CLN-617 first-in-human Phase 1 study by year end 2023.
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A poster at the 2023 SITC (Free SITC Whitepaper) Annual Meeting highlighted preclinical data demonstrating the mechanism by which CLN-617 mediates a robust abscopal anti-tumor effect in preclinical models. A Trial in Progress poster for the ongoing Phase 1 study of CLN-617 in combination with pembrolizumab was also presented.

Upcoming Milestones

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CLN-619
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Cullinan expects to report initial data from the combination dose escalation module as well as an update on the monotherapy dose escalation module at a medical conference in the second quarter of 2024.
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Cullinan expects to report initial data from disease specific dose expansion cohorts in the first half of 2025.
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Zipalertinib
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Cullinan expects completion of enrollment in the pivotal Phase 2b portion of the REZILIENT1 study by year-end 2024.
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CLN-049
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Cullinan expects to provide a clinical data update in the second half of 2024.
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CLN-418
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Cullinan expects to provide a clinical data update in the second half of 2024.
Third Quarter 2023 Financial Results

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Cash Position: Cash, cash equivalents, investments, and interest receivable were $481.9 million as of September 30, 2023. Cullinan now expects its cash resources to provide runway into the second half of 2026 based on its current operating plan. The extension from prior guidance is primarily driven by the receipt of approximately $38 million in net proceeds from Cullinan’s ATM equity program, increased interest income, and the prioritization of development plans in the longer term. Cullinan’s operating plan includes continued advancement of all programs to key data milestones in the near term.
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R&D Expenses: Research and development (R&D) expenses were $33.8 million for the third quarter of 2023, compared to $27.4 million for the second quarter of 2023. R&D expenses for the third and second quarters of 2023 included $3.2 million and $3.2 million of equity-based compensation expenses, respectively. The increase in R&D expenses was primarily related to increased chemistry, manufacturing and controls costs and higher clinical costs.
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G&A Expenses: General and administrative (G&A) expenses were $11.0 million for the third quarter of 2023, compared to $10.2 million for the second quarter of 2023. G&A expenses in the third and second quarters of 2023 included $4.5 million and $4.7 million of equity-based compensation expenses, respectively. The increase in G&A expenses, excluding equity-based compensation, was primarily driven by higher personnel costs.
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Net Loss: Net loss (before items attributable to noncontrolling interest) for the third quarter of 2023 was $39.2 million, compared with net loss of $32.2 million for the second quarter of 2023. Net losses included the items described above, partially offset by interest income of $5.9 million and $5.3 million in the third quarter and second quarter of 2023, respectively.

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Shares Outstanding: As of October 31, 2023, Cullinan had 42,780,644 common shares outstanding plus 647,500 shares of non-voting preferred stock outstanding, each of which is convertible into 10 shares of common stock.