On March 30, 2021 Cullinan Oncology, Inc. (Nasdaq: CGEM) ("Cullinan"), an oncology company seeking to drive shareholder returns by focusing on the patient, reported its financial results for the full year ended December 31, 2020 and reported on recent business highlights (Press release, Cullinan Oncology, MAR 30, 2021, View Source [SID1234577328]).
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"We are proud of the significant progress across many facets of our business in 2020 and intend to maintain that momentum in 2021," stated Owen Hughes, Chief Executive Officer of Cullinan. "We remain laser focused on delivering results for our various stakeholders through disciplined capital allocation, decisive action, prudent risk taking and creative business development. We look forward to sharing additional clinical and pre-clinical updates as the year unfolds."
2020 and Recent Portfolio Highlights:
Cullinan Pearl: Demonstrated encouraging clinical proof of concept for CLN-081 in NSCLC patients with EGFRex20ins mutations and initiated Phase 2a dose expansion in the 100 mg BID cohort.
CLN-081 is an orally available, irreversible EGFR inhibitor that is designed to selectively target cells expressing mutant EGFR variants while sparing cells expressing wild type EGFR. Cullinan is evaluating various doses of CLN-081 in a Phase 1/2a trial in patients with NSCLC harboring EGFRex20ins mutations that have progressed post chemotherapy. As of the November 10, 2020 data cut-off, among 25 evaluable patients across all dose cohorts, we observed a best overall response of partial response in 10 patients (confirmed and unconfirmed), stable disease in 14 patients and disease progression in one patient. Cullinan recently initiated Phase 2a dose expansion at the 100 mg BID dosing level, which will enable enrollment of up to 36 patients at this dose level, inclusive of 13 previously enrolled patients. Cullinan is contemplating additional expansion cohorts and intends to provide updated safety and efficacy data in mid-2021.
Cullinan MICA: Advanced CLN-619 through IND-enabling activities, including drug product manufacturing, to support an IND submission planned for the second quarter of 2021.
CLN-619 is a MICA/B-targeted, humanized IgG1 monoclonal antibody that Cullinan intends to develop in patients with advanced solid tumors. MICA/B are stress-induced ligands expressed on tumor cells and recognized by the activating NKG2D receptor present on innate and adaptive immune cells. To evade potential cytotoxic destruction by NK cells and T cells, tumors shed MICA/B from the cell surface. CLN-619 is designed to promote an antitumor response through multiple mechanisms of action, including preventing the proteolytic cleavage of MICA/B from cancer cells.
Cullinan Florentine: Acquired an exclusive license from the German Cancer Research Center (DKFZ) and the University of Tübingen to develop CLN-049, a novel FLT3 x CD3 bispecific antibody for the treatment of patients with acute myeloid leukemia (AML).
CLN-049 is a humanized bispecific antibody targeting FLT3 on target leukemic cells and CD3 on T cells, triggering cancer cell lysis via T cell cytolytic mechanisms. FLT3 is expressed frequently on AML cells and leukemic blasts but minimally on healthy blood cells, unlike other tumor surface antigens such as CD33 and CD123. Cullinan submitted an IND to the U.S. Food and Drug Administration ("FDA") for its first-in-human clinical trial evaluating CLN-049 in relapsed or refractory AML patients in January 2021. After receiving FDA feedback, Cullinan is updating the clinical protocol and intends to resubmit its IND in mid-2021.
Cullinan Amber: Launched Cullinan Amber, a company focused on developing a next generation immuno-oncology platform to deliver immune-stimulatory cytokine combinations with an enhanced therapeutic window for the treatment of cancer.
Cullinan Amber’s lead program, CLN-617, is a fusion protein uniquely combining in a single agent two potent antitumor cytokines, IL-2 and IL-12, with a collagen-binding domain for the treatment of solid tumors. The collagen-binding domain engineered into CLN-617 is designed to retain cytokines in the tumor microenvironment following intratumoral administration, thereby minimizing systemic dissemination and associated toxicities while prolonging immunostimulatory antitumor activity. In preclinical studies, murine surrogates of CLN-617 demonstrated robust single agent antitumor activity in both injected and non-injected contralateral tumors without inducing systemic toxicity. Cullinan expects to submit an IND for CLN-617 in 2022.
Cullinan NexGem: Initiated IND-enabling studies for CLN-978, an internally derived asset that seeks to address the limitations of existing CD19 bispecific antibodies.
CLN-978 is a half-life extended, humanized, single-chain T cell engager designed to simultaneously engage CD19 on target cancer cells and CD3 on T cells, triggering redirected T cells to lyse the target cancer cells. In addition to CD19 and CD3 binding domains, CLN-978 has a human serum albumin binding domain, which is designed to prolong half-life. Several design components of CLN-978, including its high affinity binder to CD19, its serum half-life extension component and its overall stability, are intended to address limitations related to blinatumomab, the only CD19-targeting bispecific T cell engager approved for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia, or ALL. Cullinan expects to submit an IND for CLN-978 in 2022.
2020 and Recent Corporate Highlights:
Executed a strategic collaboration and licensing agreement in December 2020 with Zai Lab (Shanghai) Co., Ltd. ("Zai Lab") to develop and commercialize CLN-081 in Greater China.
Raised $131.2 million in gross proceeds from an oversubscribed Series C financing in December 2020, which broadened Cullinan’s shareholder base to include additional leading life sciences focused institutions.
Completed an oversubscribed initial public offering (IPO). In January 2021, Cullinan announced the closing of its IPO of 13,685,000 shares of common stock, including the exercise in full by the underwriters of their over-allotment option, at a public offering price of $21.00 per share for gross proceeds of $287.4 million before deducting underwriting discounts and commissions and other offering expenses.
Strengthened and expanded Cullinan’s management team and Board of Directors in 2020 by promoting Jennifer Michaelson, PhD, to Chief Development Officer, Biologics, and by adding Jon Wigginton, M.D. as Chief Medical Officer, Jeff Trigilio as Chief Financial Officer, and Raymond T. Keane, Esq. as Chief Legal Officer, along with Stephen Webster to its Board of Directors.
Financial Results for Full Year 2020
Cash Position: Cash, cash equivalents and short-term investments were $210.2 million as of December 31, 2020, compared to $98.6 million as of December 31, 2019. This does not include $264.7 million in net proceeds from the company’s IPO completed in January 2021 nor does it include upfront proceeds from the Zai Lab transaction, which were received in Q1 2021. Net cash used in operating activities was $29.8 million while net cash provided from financing activities was $140.1 million for the year ended December 31, 2020.
R&D Expenses: Research and development expenses were $43.2 million for the year ended December 31, 2020, including $5.9 million of non-cash equity-based compensation expense and $6.4 million of non-cash IPR&D expense related to the Cullinan MICA transaction, which was treated as an asset acquisition.
G&A Expenses: General and administrative expenses were $17.1 million, including $9.0 million of non-cash equity-based compensation expense.
Net loss: The Company’s net loss was $59.5 million for the year ended December 31, 2020, which included $22.8 million of non-cash charges.