On May 14, 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 first quarter ended March 31, 2021 and reported on recent business highlights (Press release, Cullinan Oncology, MAY 14, 2021, View Source [SID1234579975]).
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"I am pleased with the progress we have made across our portfolio and our organization thus far in 2021," stated Owen Hughes, Chief Executive Officer of Cullinan. "Our recently completed Series C financing and Initial Public Offering will support continued development and expansion of our diverse pipeline. In addition, we look forward to sharing both clinical and preclinical updates throughout the year, including a poster presentation with updated clinical data for Cullinan Pearl at ASCO (Free ASCO Whitepaper) in June and updated preclinical data on Cullinan Amber at the Next-Gen Cytokine Therapeutics Summit in the third quarter."
Q1 2021 Portfolio Highlights
Cullinan Pearl: Based on pre-specified efficacy and safety criteria, we initiated Phase 2a dose expansion in the 100 mg BID cohort of our ongoing Phase 1/2a trial evaluating CLN-081 in NSCLC patients with EGFR ex20ins mutations. An abstract containing data from this trial as of November 2020 was selected for a poster presentation at ASCO (Free ASCO Whitepaper). The poster presentation will contain updated safety and efficacy data subsequent to the November 2020 cutoff and will be available during the conference, which takes place from June 4 – 8, 2021.
Cullinan MICA: Continued to advance CLN-619, a novel MICA/B-targeted antibody designed to engage innate and adaptive immune cell responses, through IND-enabling activities, including drug product manufacturing, to support an IND submission in the second quarter of 2021.
Cullinan Florentine: Based on FDA feedback, amended the proposed clinical trial protocol for CLN-049, a bispecific FLT3 x CD3 antibody, to support an IND resubmission in mid-2021.
Cullinan Amber: Expanded the preclinical data package for Cullinan Amber’s lead program, CLN-617, a fusion protein uniquely combining two potent antitumor cytokines, IL-2 and IL-12, in a single molecule with a collagen-binding domain for the treatment of solid tumors.
Cullinan NexGem: Continued to progress CLN-978, an internally developed half-life extended T cell engager designed to simultaneously engage CD19 and CD3, through IND-enabling development.
Q1 2021 Financial Results
Cash Position: Cash, cash equivalents and investments were $473.0 million as of March 31, 2021, compared to $210.2 million as of December 31, 2020. Net cash used in operating activities was $1.5 million. Net cash provided from financing activities was $264.6 million, which included net proceeds from the company’s IPO completed in January 2021.
R&D Expenses: Research and development expenses were $12.4 million for the quarter ended March 31, 2021, including $3.0 million of sub-licensing expense and $1.6 million of non-cash equity-based compensation expense.
G&A Expenses: General and administrative expenses were $5.2 million for the quarter ended March 31, 2021, including $1.9 million of non-cash equity-based compensation expense.
Net Income: The Company’s net income was $1.4 million for the quarter ended March 31, 2021, which included $18.9 million of revenue from the license agreement with Zai Lab (Shanghai) Co., Ltd.