Cue Biopharma Reports First Quarter 2024 Financial Results and Recent Business Highlights
May 09 2024 - 4:05PM
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 $1.7 million and $0.2
million for the three months ended March 31, 2024 and 2023,
respectively. The increase was due to revenue earned from our
Collaboration and Option Agreement with Ono Pharmaceutical, which
was executed in February 2023.
Research and development expenses were $10.2 million and $9.4
million for the three months ended March 31, 2024 and 2023,
respectively. The increase was primarily due to an increase in
clinical trial expenses.
General and administrative expenses were $4.2 million for both
the three months ended March 31, 2024 and 2023.
As of March 31, 2024, the Company had $41.0 million in cash
and cash equivalents. We expect our current cash and cash
equivalents to fund operations into the first quarter of 2025.
|
Cue Biopharma, Inc.Condensed Consolidated
Statements of Operations and Comprehensive
Loss(Unaudited, In thousands, except share and per
share amounts) |
|
|
|
|
|
|
|
Three Months
EndedMarch 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 BiopharmaCue 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 StatementsThis 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 CommunicationsCue Biopharma,
Inc.mcampinell@cuebio.com
Media ContactJonathan PappasLifeSci
Communicationsjpappas@lifescicomms.com
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