Cue Biopharma Reports Fourth Quarter and Full Year 2023 Financial Results and Updated Business Highlights
- Positive data from Phase 1 trials of CUE-101 and CUE-102 presented at key conferences.
- Completed enrollment of 25 patients in 1L Phase 1b dose expansion trial of CUE-101.
- Received FDA guidance for potential registrational trials of CUE-101 in monotherapy and combination settings.
- Increased collaboration revenue in 2023 due to strategic partnership with Ono Pharmaceutical.
- Research and development expenses slightly decreased in 2023.
- Deployed Immuno-STAT platform for developing therapeutic biologics candidate CUE-501.
- Cash reserves declined from $76.3 million in 2022 to $48.5 million in 2023.
- Operations expected to be funded until the first quarter of 2025.
- Cash reserves declined significantly from 2022 to 2023.
- Loss from operations in 2023 increased compared to 2022.
- General and administrative expenses increased in 2023.
- Net loss per common share increased in 2023 compared to 2022.
The financial results reported by Cue Biopharma, Inc. highlight a year-over-year increase in collaboration revenue, which is a positive indicator of the company's ability to monetize its strategic partnerships, particularly with Ono Pharmaceutical. This uptick in revenue, from approximately $1.2 million in 2022 to $5.5 million in 2023, suggests that the company's collaborative efforts are beginning to bear fruit, which could be a signal to investors about the potential for future revenue growth.
However, the reported increase in both research and development expenses and general and administrative expenses indicates that the company is still heavily investing in its product pipeline and operational structure. While this is expected for a clinical-stage biopharmaceutical company, investors should monitor the balance between these expenses and revenue closely to assess the sustainability of the company's financial position.
The cash reserves, having decreased from $76.3 million to $48.5 million year-over-year, may raise concerns about the burn rate. Despite this, the management's projection that current funds will last into the first quarter of 2025 provides a short-term cushion. This runway might offer the company time to advance its clinical programs to stages that could potentially attract additional funding or partnerships.
The presented clinical data from the ongoing Phase 1 trials of CUE-101 and CUE-102 provide noteworthy insights into the efficacy of these candidates. The comparison of median overall survival (mOS) and overall response rates (ORR) with historical data from third-party trials is particularly compelling. For instance, CUE-101 monotherapy's mOS of 20.8 months, when compared to 7.5 and 8.4 months with standard care checkpoint inhibitors, suggests a significant improvement in patient outcomes. This could represent a substantial advancement in the treatment of HPV+ recurrent/metastatic head and neck squamous cell carcinoma.
Moreover, the favorable tolerability profile reported for CUE-101 in both monotherapy and combination trials could be a critical factor in its clinical success and eventual market adoption. The guidance received from the FDA regarding the potential paths for registrational trials further de-risks the development process and could accelerate the timeline to commercialization, which is a key consideration for stakeholders.
From a market perspective, the advancements Cue Biopharma is making in its oncology and autoimmune disease programs are strategically significant. The company's focus on selective modulation of disease-specific T cells positions it within a niche yet growing segment of the immunotherapy market. The collaboration with Ono Pharmaceutical, a well-established entity in the pharmaceutical industry, not only enhances the credibility of Cue Biopharma's research but also opens doors to the Asian markets, potentially broadening the commercial reach of its candidates.
The positive data from clinical trials and the progression of preclinical programs to IND candidate selection stage are likely to have a positive impact on investor sentiment. These developments could lead to increased investor interest and potentially higher stock valuations, as the market often responds favorably to biopharmaceutical companies that demonstrate clinical progress and clear regulatory pathways. However, it is essential to consider the competitive landscape and the fact that successful clinical trial results do not guarantee market success, due to factors such as market saturation, pricing pressures and reimbursement challenges.
BOSTON, April 08, 2024 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively modulate disease-specific T cells, today reported fourth quarter and full year 2023 financial results.
- Presented additional positive data from the ongoing Phase 1 trials of CUE-101 in first line (1L) human papillomavirus positive (HPV+) recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) in combination with standard of care (SOC) checkpoint inhibitor (CPI) KEYTRUDA® (pembrolizumab) and as a monotherapy in second line and beyond (2L+) HPV+ R/M HNSCC, as well as CUE-102 in Wilms’ Tumor 1 (WT1) positive cancers at the Society for Immunotherapy of Cancer’s (SITC) 38th Annual Meeting in November 2023.
- Completed enrollment of 25 patients in the 1L Phase 1b dose expansion trial of CUE-101 in combination with SOC CPI pembrolizumab.
- Presented notable updates from the ongoing Phase 1 clinical trials of CUE-101 and CUE-102 at the 2024 Oppenheimer Annual Healthcare Life Sciences Conference in February:
- CUE-101 monotherapy in 2L HPV+ R/M HNSCC demonstrated median overall survival (mOS) of 20.8 months vs. historical third-party mOS of 7.5 and 8.4 months with two different CPIs: OPDIVO® (nivolumab) and pembrolizumab, respectively
- CUE-101 in combination with pembrolizumab in 1L R/M HNSCC showed an overall response rate (ORR) of
46% vs.19% with pembrolizumab alone in a third-party trial and median progression free survival (mPFS) of 8.3 months vs. 3.2 months with pembrolizumab alone in a third-party trial - CUE-101 continued to demonstrate favorable tolerability in the monotherapy and combination trials
- CUE-102 monotherapy in late-stage refractory metastatic cancers demonstrated tumor reductions and stable disease in multiple patients in the dose escalation Phase 1 trial
- Concluded Type B meeting with FDA receiving guidance for potential paths for CUE-101 registrational trials in both monotherapy and combination settings.
- Advanced preclinical program CUE-401 in collaboration with Ono Pharmaceutical for the treatment of autoimmune and inflammatory diseases. Preclinical activity demonstrated in disease models supported moving toward selection of an Investigational New Drug (IND) candidate.
- Deployed the Immuno-STAT™ platform to develop a therapeutic biologics candidate, CUE-501, a bispecific Immuno-STAT that is designed to direct selective memory T cells to deplete B cells, to address autoimmune and inflammatory diseases.
“Cue Biopharma continues to make measurable progress advancing its clinical oncology programs CUE-101 and CUE-102, as well as its lead preclinical autoimmune and inflammatory disease candidate CUE-401, partnered with Ono Pharmaceutical,” said Daniel Passeri, chief executive officer of Cue Biopharma. “We also accomplished an important milestone earlier this year with guidance received from the FDA for potential CUE-101 registrational trials both in the monotherapy and combination settings providing further risk-reduction and defined resource requirements for achieving the next phase of our strategic corporate objectives. I believe that these key milestones, including progress addressing additional therapeutic approaches for the treatment of autoimmune and inflammatory diseases with CUE-401 and CUE-501, bolster our competitive positioning in securing value for our shareholders and most importantly, patients suffering from these debilitating and life-threatening diseases.”
Fourth Quarter 2023 Financial Results
The Company reported collaboration revenue of approximately
Research and development expenses were
General and administrative expenses were
Full Year 2023 Financial Results
The Company reported collaboration revenue of approximately
Research and development expenses were approximately
General and administrative expenses were approximately
As of December 31, 2023, the Company had approximately
| Cue Biopharma, Inc. | ||||||||||||||||
| Consolidated Statements of Operations and Comprehensive Loss | ||||||||||||||||
| (In thousands, except per share information) | ||||||||||||||||
| Three Months Ended December 31, | Year Ended December 31, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Collaboration revenue | $ | 1,821 | $ | 151 | $ | 5,490 | $ | 1,245 | ||||||||
| Operating expenses (income): | ||||||||||||||||
| General and administrative | 4,609 | 3,704 | 16,680 | 16,169 | ||||||||||||
| Research and development | 10,887 | 11,332 | 40,802 | 38,578 | ||||||||||||
| Loss (gain) on fixed asset disposal and right-of-use asset termination | 157 | (19 | ) | 157 | (277 | ) | ||||||||||
| Total operating expenses | 15,653 | 15,017 | 57,639 | 54,470 | ||||||||||||
| Loss from operations | $ | (13,832 | ) | $ | (14,866 | ) | $ | (52,149 | ) | $ | (53,225 | ) | ||||
| Other income (expense): | ||||||||||||||||
| Interest income | 905 | 632 | 2,661 | 928 | ||||||||||||
| Interest expense | (507 | ) | (359 | ) | (1,245 | ) | (713 | ) | ||||||||
| Loss before income taxes | $ | (13,434 | ) | $ | (14,593 | ) | $ | (50,733 | ) | $ | (53,010 | ) | ||||
| Provision for income taxes | - | - | - | - | ||||||||||||
| Net loss | $ | (13,434 | ) | $ | (14,593 | ) | $ | (50,733 | ) | $ | (53,010 | ) | ||||
| Unrealized gain (loss) from available-for-sale securities | - | (4 | ) | 96 | (96 | ) | ||||||||||
| Comprehensive loss | (13,434 | ) | (14,597 | ) | (50,637 | ) | (53,106 | ) | ||||||||
| Net loss per common share – basic and diluted | $ | (0.28 | ) | $ | (0.37 | ) | $ | (1.11 | ) | $ | (1.49 | ) | ||||
| Weighted average common shares outstanding – basic and diluted | 47,181,633 | 39,171,994 | 45,754,794 | 35,649,134 | ||||||||||||
| Cue Biopharma, Inc. | |||||
| Selected Consolidated Balance Sheet Data | |||||
| (In thousands) | |||||
| December 31, 2023 | December 31, 2022 | ||||
| Cash and cash equivalents | $ | 48,514 | $ | 51,614 | |
| Marketable securities | - | 24,675 | |||
| Total current assets | 51,454 | 77,187 | |||
| Working capital | 34,373 | 65,639 | |||
| Total assets | 61,530 | 91,283 | |||
| Total stockholders' equity | 37,085 | 65,683 | |||
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 (Twitter) 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 paths for CUE-101 registrational trials in both monotherapy and combination settings; its beliefs regarding its competitive positioning to secure value for shareholders and patients; and the cash runway of the company and the sufficiency of the company’s cash, cash equivalents, and marketable securities 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 positive data was reported from the Phase 1 trials of CUE-101 and CUE-102?
How many patients were enrolled in the 1L Phase 1b dose expansion trial of CUE-101?
What guidance did Cue Biopharma receive from the FDA?
Why did collaboration revenue increase in 2023?
What was the change in research and development expenses in 2023 compared to 2022?
What platform did Cue Biopharma deploy for developing therapeutic biologics?
How did the company's cash reserves change from 2022 to 2023?
Until when are Cue Biopharma's operations expected to be funded with current reserves?
