Cue Biopharma Reports Second Quarter 2020 Results and CUE-101 Phase 1 Dose Escalation Trial Updates
“We are very pleased with the progress we continue to make advancing CUE-101 through the ongoing Phase 1 monotherapy dose-escalation trial,” said
“We remain well positioned for continued execution of our development plans for our lead asset CUE-101 which is representative of our IL-2 based CUE-100 series and the continued build out of our pipeline via our proprietary protein engineering approach,” said
Second-Quarter 2020 Financial Results
The Company had steady collaboration revenue of approximately
Research and development expenses were
General and administrative expenses were
“As of
- Advancing CUE-101 into cohort 6 in its ongoing multicenter, open-label, dose escalation Phase 1 monotherapy trial for patients with human papilloma virus-positive recurrent/metastatic head and neck squamous cell carcinoma (HPV+ HNSCC).
- Extended cash runway during the second quarter through an ATM equity offering sales agreement for aggregate proceeds of
$42.4 million , net of commissions paid, withStifel Nicolaus & Company, Inc. , who acted as sales agent. - Announced a peer-reviewed paper titled “Mechanistic dissection of the PD-L1:B7-1 co-inhibitory immune complex” in PLOS ONE. The study results describe novel functional interactions that regulate responses mediated by the B7 family of immune checkpoint molecules and the generation and evaluation of libraries of these molecules with directed mutations providing novel biological properties with potential therapeutic applications.
- Entered into a research collaboration agreement with Dr.
Michael Dustin and theUniversity of Oxford to determine the molecular mechanisms underlying the activity of its IL-2 based CUE-100 series Immuno-STAT™ (Selective Targeting and Alteration of T cells) Biologics. - Appointed
Kerri-Ann Millar as Chief Financial Officer after serving as the company’s principal finance and accounting officer since 2018.
Members of the
Investors: | 855-327-6837 | |
International: | 631-891-4304 | |
Conference ID: | 10010557 | |
Webcast: | http://public.viavid.com/index.php?id=141034 |
About Cue Biopharma
Headquartered in Cambridge,
For more information, visit www.cuebiopharma.com and follow us on Twitter https://twitter.com/CueBiopharma.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are intended to be covered by the “safe harbor” created by those sections. Forward-looking statements, which are based on certain assumptions and describe our 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. All statements other than statements of historical facts included in this press release regarding our strategies, prospects, financial condition, operations, costs, plans and objectives are forward-looking statements. Examples of forward-looking statements include, among others, statements we make regarding anticipated results of our drug development efforts, including study results, and our expectations regarding regulatory developments and expected future operating results. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, our limited operating history, limited cash and a history of losses; our ability to achieve profitability; potential setbacks in our research and development efforts including negative or inconclusive results from our preclinical studies, our ability to secure required U.S. Food and Drug Administration (“FDA”) or other governmental approvals for our product candidates and the breadth of any approved indication; adverse effects caused by public health pandemics, including COVID-19, including possible effects on our operations and clinical trials; negative or inconclusive results from our clinical studies or serious and unexpected drug-related side effects or other safety issues experienced by participants in our clinical trials; delays and changes in regulatory requirements, policy and guidelines including potential delays in submitting required regulatory applications to the FDA; our reliance on licensors, collaborators, contract research organizations, suppliers and other business partners; our ability to obtain adequate financing to fund our business operations in the future; ; and the other risks and uncertainties described in the Risk Factors and in Management's Discussion and Analysis of Financial Condition and Results of Operations sections of our 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 us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake 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
VP, Investor Relations & Corporate Development
gzavoico@cuebio.com
Media Contact
achen@lifescicomms.com
Selected Consolidated Statement of Operations | ||||||
(in thousands) | ||||||
Three Months Ended | ||||||
2020 | 2019 | |||||
Collaboration revenue | $ | 1,075 | $ | 1,055 | ||
Operating expenses: | ||||||
General and administrative | 3,898 | 3,419 | ||||
Research and development | 8,119 | 6,867 | ||||
Total operating expenses | 12,017 | 10,286 | ||||
Loss from operations | (10,942 | ) | (9,231 | ) | ||
Other income: | ||||||
Interest income | 134 | 96 | ||||
Other income / (expense) net | (25 | ) | 26 | |||
Net Loss | $ | (10,833 | ) | $ | (9,109 | ) |
Net loss per common share – basic and diluted | $ | (0.38 | ) | $ | (0.46 | ) |
Weighted average common shares outstanding – basic and diluted | 28,222 | 20,821 | ||||
Selected Consolidated Balance Sheet Data | ||||||
(in thousands) | ||||||
2020 |
2019 |
|||||
Cash and cash equivalents | $ | 59,749 | $ | 44,290 | ||
Marketable securities | 25,179 | 15,120 | ||||
Total current assets | 88,353 | 61,025 | ||||
Working Capital | 73,491 | 49,370 | ||||
Total assets | 101,353 | 71,605 | ||||
Total Stockholders' equity | 80,154 | 54,584 |
Source: Cue Biopharma, Inc.