On March 21, 2023 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of injectable biologics to selectively engage and modulate disease-specific T cells directly within the patient’s body, reported fourth quarter and full year 2022 financial results (Press release, Cue Biopharma, MAR 21, 2023, View Source [SID1234629119]).
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"2022 was a strategically important and significant year for Cue Biopharma with the emergence of positive clinical data from our ongoing trials with CUE-101 – our lead oncology drug product candidate from the CUE-100 series – validating and derisking our Immuno-STAT platform, and having accessed opportunities to secure a strong financial position that enable us to further execute on our corporate and clinical goals throughout 2023 and well into 2024," said Daniel Passeri, chief executive officer of Cue Biopharma. "Importantly, we plan to present updated clinical data from our representative programs from the CUE-100 series oncology programs at an upcoming scientific conference with the aim of further demonstrating the potential significance of our platform and clinical development approach for the treatment of multiple cancers. Additionally, we look forward to advancing our lead autoimmune disease asset, CUE-401, toward the clinic through our recent partnership with Ono Pharmaceutical and will continue to seek similar partnerships that support building out our promising pipeline of potential breakthrough therapeutics."
Fourth Quarter 2022 Financial Results
The Company reported collaboration revenue of approximately $0.15 million and $8.3 million for the three months ended December 31, 2022 and 2021, respectively. The decrease was primarily due to the completion of the research phase of the LG Chem collaboration in the first quarter of 2022.
Research and development expenses were $11.3 million and $11.5 million for the three months ended December 31, 2022 and 2021, respectively. The decrease was due to the completion of enrollment in the CUE-101 Phase 1 monotherapy clinical trial in the first half of 2022.
General and administrative expenses were $3.7 million and $4.7 million for the three months ended December 31, 2022 and 2021, respectively. The decrease was due primarily to recording lower stock-based compensation expense during the fourth quarter of 2022 versus the same period in 2021.
Full Year 2022 Financial Results
The Company reported collaboration revenue of approximately $1.2 million and $14.9 million for the years ended December 31, 2022 and 2021, respectively. The decrease was primarily due to completion of the research phase of the LG Chem collaboration during the first quarter of the year.
Research and development expenses were $38.6 million and $41.3 million for the years ended December 31, 2022 and 2021, respectively. The decrease was primarily due to a decrease in costs related to the CUE-101 Phase 1 monotherapy clinical trial as enrollment was completed in the first half of 2022, a decrease in CUE-101 combination clinical trial costs and lower manufacturing costs for CUE-101 and CUE-102 clinical material during 2022, as compared to 2021.
General and administrative expenses were $16.2 million and $17.3 million for the years ended December 31, 2022 and 2021, respectively. The decrease in general and administrative expense was due primarily to lower professional and consulting fees, stock-based compensation and rent in 2022.
As of December 31, 2022, the Company had approximately $76.3 million in cash, cash equivalents and marketable securities compared with $64.4 million as of December 31, 2021. We expect our current cash, cash equivalents, and marketable securities to fund operations into the second half of 2024.
Cue Biopharma, Inc.
Condensed Consolidated Statement of Operations
(In thousands, except per share information)
Three Months Ended
December 31, Year Ended
December 31,
2022 2021 2022 2021
Collaboration revenue $ 151 $ 8,254 $ 1,245 $ 14,941
Operating expenses:
General and administrative 3,704 4,647 16,169 17,306
Research and development 11,332 11,501 38,578 41,347
Gain on right-of-use asset termination (19 ) - (277 ) -
Total operating expenses 15,017 16,148 54,470 58,653
Loss from operations (14,866 ) (7,894 ) (53,225 ) (43,712 )
Other income:
Interest income 632 4 928 46
Interest expense (359 ) - (713 ) -
Loss before income taxes $ (14,593 ) $ (7,890 ) $ (53,010 ) $ (43,666 )
Provision for income taxes - (495 ) - (495 )
Net loss $ (14,593 ) $ (8,385 ) $ (53,010 ) $ (44,161 )
Unrealized loss from available-for-sale securities (4 ) - (96 ) (7 )
Comprehensive loss (14,597 ) (8,385 ) (53,106 ) (44,168 )
Net loss per common share – basic and diluted $ (0.37 ) $ (0.26 ) $ (1.49 ) $ (1.41 )
Weighted average common shares outstanding – basic and diluted 39,171,994 31,941,699 35,649,134 31,285,418
Cue Biopharma, Inc.
Selected Consolidated Balance Sheet Data
(In thousands)
December 31,
2022
December 31,
2021
Cash and cash equivalents $ 51,614 $ 64,371
Marketable securities 24,675 -
Total current assets 77,187 68,468
Working Capital 65,639 55,680
Total assets 91,283 83,401
Total Stockholders’ equity 65,683 65,492