Cue Biopharma Reports First Quarter 2024 Financial Results and Recent Business Highlights
Cue Biopharma, Inc. reported their first-quarter 2024 financial results, showcasing an increase in collaboration revenue to $1.7 million due to partnerships. They highlighted advancements in clinical trials for CUE-101 and CUE-102, as well as the expansion of their pipeline to include programs for autoimmune and inflammatory diseases. The company emphasized progress in their autoimmune program, CUE-401, with Ono Pharmaceutical, and the development of the bispecific Immuno-STAT CUE-500 series. Financially, Cue Biopharma reported $41.0 million in cash and cash equivalents as of March 31, 2024, with expectations to fund operations into the first quarter of 2025.
Increased collaboration revenue of $1.7 million in the first quarter 2024 due to the Collaboration and Option Agreement with Ono Pharmaceutical.
Advancements in clinical trials for CUE-101 and CUE-102, showcasing progress in developing novel biologics to modulate T cells.
Expansion of the pipeline to include the preclinical CUE-500 series for autoimmune and inflammatory diseases through T cell-mediated B cell depletion.
Significant progress in the autoimmune program CUE-401 with Ono Pharmaceutical, aiming to address multiple autoimmune and inflammatory diseases.
Reported $41.0 million in cash and cash equivalents as of March 31, 2024, with expectations to fund operations into the first quarter of 2025.
Loss from operations of $12.7 million in the first quarter 2024, indicating a financial deficit despite revenue growth.
General and administrative expenses remained constant at $4.2 million, potentially impacting profitability.
Research and development expenses increased to $10.2 million, primarily due to rising clinical trial costs.
Looking at the first quarter financial results for Cue Biopharma, the notable increase in collaboration revenue is a positive signal. The collaboration with Ono Pharmaceutical, which appears to be fruitful, has generated a nearly tenfold increase in revenue year-over-year. This is indicative of the company's ability to leverage partnerships to boost its income streams. However, the increased R&D expenses align with the company's efforts to advance its clinical trials, signaling a re-investment into its core pipeline.
Despite these developments, the net loss has decreased slightly compared to the previous year, suggesting some efficiency in managing expenses despite higher R&D outlays. Investors should consider the company's runway, with cash reserves anticipated to last until the first quarter of 2025. For a clinical-stage biopharmaceutical firm, this runway is critical. It offers a cushion for ongoing research without the immediate need for further capital raising, which could dilute current shares.
From a market perspective, the advancements in Cue Biopharma's clinical trials and interactions with the FDA could signal positive momentum. The industry places significant weight on regulatory pathways and defining a registrational path is a key milestone. The expansion of the autoimmune pipeline, with the CUE-500 series aiming at T cell-mediated B cell depletion, is reflective of the company's strategic focus on diversifying its product offerings.
The anticipation around the oral and poster presentations at the ASCO Annual Meeting should also be of interest, as such events often serve as catalysts for stock volatility. Positive data presentations can significantly enhance investor perceptions and increase visibility among potential partners. It's important to monitor the outcomes of these meetings for potential impacts on stock performance.
From a scientific perspective, the progress of Cue Biopharma's Immuno-STAT™ platform is noteworthy. The bi-specific nature of the CUE-500 series is cutting-edge, aiming to redirect virus-specific T cells to deplete B cells, which is a novel approach in treating autoimmune and inflammatory diseases. This could represent a new therapeutic paradigm if clinical success follows preclinical promise. The advanced preclinical CUE-401 program, also for autoimmune and inflammatory diseases, suggests a depth to the pipeline that investors should appreciate. This diversity reduces dependency on a single asset and spreads the potential risk across multiple programs.
BOSTON, May 09, 2024 (GLOBE NEWSWIRE) -- 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, today provided a business and financial update for the first quarter 2024.
Recent Business Highlights
- CUE-101 abstract accepted for an oral presentation and poster presentation at the upcoming 2024 American Society of Clinical Oncology (ASCO) Annual Meeting scheduled for May 31-June 4, 2024.
- CUE-102 abstract accepted for a poster presentation at the upcoming 2024 American Society of Clinical Oncology (ASCO) Annual Meeting scheduled for May 31-June 4, 2024.
- Advanced preclinical CUE-401 program, in collaboration with Ono Pharmaceutical, with potential for broad application across multiple autoimmune and inflammatory diseases.
- Expanded pipeline to include the preclinical CUE-500 series for the treatment of autoimmune and inflammatory diseases via T cell-mediated B cell depletion.
- Immuno-STAT™ platform posters for oncology and autoimmune diseases accepted for presentation at PEGS Boston Summit 2024 to be held May 13-14.
“We have made significant progress during the first quarter on several fronts, including further advancement of our CUE-101 clinical trial and a meeting with the FDA to define a registrational path forward for the program, as well as continued advancement of the Phase 1 clinical trial for CUE-102,” said Daniel Passeri, chief executive officer of Cue Biopharma. “Additionally, important progress has been made advancing our autoimmune program CUE-401, in collaboration with Ono Pharmaceutical, and expanding our autoimmune pipeline with the bispecific Immuno-STAT CUE-500 series designed to redirect virus-specific T cells to deplete B cells in autoimmune and inflammatory diseases. We believe our strategy of demonstrating the transformative breakthrough potential of our platform to address a broad spectrum of indications from cancer and autoimmune disease positions us well to potentially deliver value creation for our shareholders.”
First Quarter 2024 Financial Results
The Company reported collaboration revenue of
Research and development expenses were
General and administrative expenses were
As of March 31, 2024, the Company had
| Cue Biopharma, Inc. Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited, In thousands, except share and per share amounts) | ||||||
| Three Months Ended March 31, | ||||||
| 2024 | 2023 | |||||
| Collaboration revenue | $ | 1,717 | $ | 187 | ||
| Operating expenses: | ||||||
| General and administrative | 4,186 | 4,176 | ||||
| Research and development | 10,199 | 9,391 | ||||
| Total operating expenses | 14,385 | 13,567 | ||||
| Loss from operations | (12,668 | ) | (13,380 | ) | ||
| Other income (expense): | ||||||
| Interest income | 562 | 641 | ||||
| Interest expense | (241 | ) | (370 | ) | ||
| Total other income (expense) | 321 | 271 | ||||
| Net loss | $ | (12,347 | ) | $ | (13,109 | ) |
| Unrealized gain from available-for-sale securities | - | 57 | ||||
| Comprehensive loss | $ | (12,347 | ) | $ | (13,052 | ) |
| Net loss per common share – basic and diluted | $ | (0.25 | ) | $ | (0.29 | ) |
| Weighted average common shares outstanding – basic and diluted | 49,466,711 | 44,652,353 | ||||
| Cue Biopharma, Inc. Condensed Consolidated Balance Sheets (Unaudited, In thousands) | ||||||
| March 31, 2024 | December 31, 2023 | |||||
| Assets | ||||||
| Cash and cash equivalents | $ | 41,029 | $ | 48,514 | ||
| Other assets | 12,922 | 13,016 | ||||
| Total assets | $ | 53,951 | $ | 61,530 | ||
| Liabilities and stockholders’ equity | ||||||
| Liabilities | $ | 23,913 | $ | 24,445 | ||
| Stockholders' equity | 30,038 | 37,085 | ||||
| Total Liabilities and stockholders’ equity | $ | 53,951 | $ | 61,530 | ||
About Cue Biopharma
Cue Biopharma, a clinical-stage biopharmaceutical company, is developing a novel class of injectable biologics to selectively engage and modulate disease-specific T cells directly within the patient’s body. The company’s proprietary platform, Immuno-STAT™ (Selective Targeting and Alteration of T cells) and biologics are designed to harness the curative potential of the body’s intrinsic immune system through the selective modulation of disease-specific T cells without the adverse effects of broad systemic immune modulation.
Headquartered in Boston, Massachusetts, we are led by an experienced management team and independent Board of Directors with deep expertise in immunology and immuno-oncology as well as the design and clinical development of protein biologics.
For more information please visit www.cuebiopharma.com and follow us on X and LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, those regarding: the company’s belief that the Immuno-STAT platform stimulates targeted immune modulation through the selective engagement of disease-relevant T cells and the applicability of the company’s platform across many cancers and autoimmune diseases; the company’s business strategies, plans and prospects, including potential clinical paths for CUE-101; the company’s collaboration with Ono Pharmaceutical; the company’s beliefs regarding its competitive positioning to deliver value creation for shareholders; and the cash runway of the company and the sufficiency of the company’s cash and cash equivalents to fund its operations. Forward-looking statements, which are based on certain assumptions and describe the company’s future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “would,” “could,” “seek,” “intend,” “plan,” “goal,” “project,” “estimate,” “anticipate,” “strategy,” “future,” “likely” or other comparable terms, although not all forward-looking statements contain these identifying words. All statements other than statements of historical facts included in this press release regarding the company’s strategies, prospects, financial condition, operations, costs, plans and objectives are forward-looking statements. Important factors that could cause the company’s actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the company’s limited operating history, limited cash and a history of losses; the company’s ability to achieve profitability; potential setbacks in the company’s research and development efforts including negative or inconclusive results from its preclinical studies or clinical trials or the company’s ability to replicate in later clinical trials positive results found in preclinical studies and early-stage clinical trials of its product candidates; serious and unexpected drug-related side effects or other safety issues experienced by participants in clinical trials; its ability to secure required U.S. Food and Drug Administration (“FDA”) or other governmental approvals for its product candidates and the breadth of any approved indication; adverse effects caused by public health pandemics, including possible effects on the company’s operations and clinical trials; delays and changes in regulatory requirements, policy and guidelines including potential delays in submitting required regulatory applications to the FDA; the company’s reliance on licensors, collaborators, contract research organizations, suppliers and other business partners; the company’s ability to obtain adequate financing to fund its business operations in the future and ability to continue as a going concern; the company’s ability to maintain and enforce necessary patent and other intellectual property protection; competitive factors; general economic and market conditions and the other risks and uncertainties described in the Risk Factors and Management's Discussion and Analysis of Financial Condition and Results of Operations sections of the company’s most recently filed Annual Report on Form 10-K and any subsequently filed Quarterly Report(s) on Form 10-Q. Any forward-looking statement made by the company in this press release is based only on information currently available to the company and speaks only as of the date on which it is made. The company undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
Investor Contact
Marie Campinell
Senior Director, Corporate Communications
Cue Biopharma, Inc.
mcampinell@cuebio.com
Media Contact
Jonathan Pappas
LifeSci Communications
jpappas@lifescicomms.com
FAQ
What was Cue Biopharma's collaboration revenue in the first quarter of 2024?
What programs did Cue Biopharma expand its pipeline to include for autoimmune and inflammatory diseases?
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What was the loss from operations in the first quarter of 2024 for Cue Biopharma?
