Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage
biopharmaceutical company developing a novel class of therapeutic
biologics to selectively engage and modulate disease-specific T
cells, provided a business and financial update for the second
quarter 2024.
Recent Business Highlights
- Delivered oral
presentation on updated data from ongoing Phase 1(b) trial of
CUE-101 as a first line (1L) therapy in human papillomavirus
positive (HPV+) recurrent/metastatic head and neck squamous cell
carcinoma (R/M HNSCC), 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 a poster
presentation on CUE-102 in Wilms’ Tumor 1 (WT1) positive cancers at
the 2024 American Society of Clinical Oncology (ASCO) Annual
Meeting held in June.
- Further advanced
autoimmune program CUE-401, partnered with Ono Pharmaceutical,
Ltd., and CUE-501, our lead CUE-500 series asset.
- Programs are
designed to address significant unmet medical need in large patient
populations across numerous autoimmune and inflammatory
diseases
- Preclinical data has
progressed well with consistent positive activity in multiple
disease models
- Initiated
strategic prioritization of autoimmune programs to focus upon
near-term and intermediate value creation potential, to enable
optimization and reduction of capital requirements, while retaining
oncology programs, CUE-101 and CUE-102, as promising clinical data
further matures.
- Positive
observations as updated data continues to mature from ongoing
oncology clinical trials, CUE-101 and CUE-102.
- CUE-101 in
combination with pembrolizumab in 1L R/M HNSCC, as of August 4,
2024, demonstrated an objective response rate (ORR) of 46% in all
patients with combined positive score (CPS) ≥1 and 50% ORR with CPS
<20, median progression free survival (mPFS) of 5.8 months and
median overall survival (mOS) of 21.8 months
- CUE-101 monotherapy
in 2L+ HPV+ R/M HNSCC demonstrated mOS of 20.8 months vs. mOS of
7.5 and 8.4 months observed in trials in 2L patients with two
different CPIs: OPDIVO® (nivolumab) and pembrolizumab,
respectively
- CUE-102 monotherapy
in late-stage refractory metastatic cancers has been well tolerated
and to date, has demonstrated dose-dependent increases in exposure
and activation and expansion of WT1-specific T cells with observed
anti-tumor activity in two gastric and ovarian patients, as well as
disease control in several tumor types in multiple patients in the
dose escalation Phase 1 trial
“We had a highly productive second quarter with promising
clinical data continuing to mature from our ongoing oncology trials
further supporting our belief that CUE-101, as our lead
representative CUE-100 program, has the potential to establish a
new standard of care for HPV+ HNSCC patients,” said Daniel Passeri,
chief executive officer of Cue Biopharma. “These observations,
combined with the ongoing advancements of our prioritized
autoimmune programs and the recent implementation of a highly
focused, strategic business model underscoring our objectives to
proactively manage and mitigate capital access risk, support the
transformational potential of our Immuno-STAT™ platform to
accomplish our mission of developing breakthrough immunotherapies
to establish a new standard of care in the treatment of cancer and
autoimmune disease.”
Second Quarter 2024 Financial Results The
Company reported collaboration revenue of $2.7 million and
$1.4 million for the three months ended June 30, 2024 and
2023, respectively. The increase was due to the timing of revenue
earned from the collaboration and option agreement with Ono
Pharmaceutical Co., Ltd.
Research and development expenses were $9.5 million
and $10.7 million for the three months ended June 30,
2024 and 2023, respectively. The decrease was primarily due to
a decrease in research and laboratory costs and compensation
expense.
General and administrative expenses were $3.5 million
and $4.2 million for the three months ended June 30,
2024 and 2023, respectively. The decrease was primarily due to
decreases in professional fees, employee compensation, overhead,
and stock-based compensation expense.
The Company reported collaboration revenue of $4.4 million and
$1.6 million for the six months ended June 30, 2024 and 2023,
respectively. The increase was due to the timing of revenue earned
from the collaboration and option agreement with Ono Pharmaceutical
Co., Ltd.
Research and development expenses were $19.7 million
and $20.0 million for the six months ended June 30,
2024 and 2023, respectively. The decrease was primarily due to
a decrease in research and laboratory costs and stock-based
compensation expense, partially offset by an increase in clinical
expenses.
General and administrative expenses were $7.7 million
and $8.4 million for the six months ended June 30,
2024 and 2023, respectively. The decrease was primarily due to
decreases in professional fees and employee
compensation. As
of June 30, 2024, the Company had $30.0 million in cash
and cash equivalents compared with $48.5 million as of
June 30, 2023. We expect our current cash, cash equivalents,
and marketable securities to fund operations through the second
quarter of 2025.
Cue Biopharma, Inc. |
Condensed Consolidated Statement of Operations and
Comprehensive Loss(Unaudited) |
(In thousands, except share and per share
amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
EndedJune 30, |
|
Six Months EndedJune 30, |
|
|
2024 |
|
2023 |
|
2024 |
|
2023 |
Collaboration revenue |
$ |
2,658 |
|
$ |
1,382 |
|
$ |
4,375 |
|
$ |
1,570 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
General and administrative |
|
3,511 |
|
|
4,249 |
|
|
7,697 |
|
|
8,425 |
|
Research and development |
|
9,530 |
|
|
10,650 |
|
|
19,729 |
|
|
20,041 |
|
Total operating expenses |
|
13,041 |
|
|
14,899 |
|
|
27,426 |
|
|
28,466 |
|
Loss from
operations |
|
(10,383) |
|
|
(13,517) |
|
|
(23,051) |
|
|
(26,896) |
|
Other income
(expense): |
|
|
|
|
|
|
|
|
Interest income |
|
427 |
|
|
564 |
|
|
989 |
|
|
1,056 |
|
Interest expense |
|
(215) |
|
|
(232) |
|
|
(456) |
|
|
(454) |
|
Total other income,
net |
|
212 |
|
|
332 |
|
|
533 |
|
|
602 |
|
Net loss |
$ |
(10,171) |
|
$ |
(13,185) |
|
$ |
(22,518) |
|
$ |
(26,294) |
|
Unrealized gain from
available-for-sale securities |
|
— |
|
|
34 |
|
|
— |
|
|
91 |
|
Comprehensive
loss |
$ |
(10,171) |
|
$ |
(13,151) |
|
$ |
(22,518) |
|
$ |
(26,203) |
|
Net loss per common share –
basic and diluted |
$ |
(0.20) |
|
$ |
(0.29) |
|
$ |
(0.45) |
|
$ |
(0.59) |
|
Weighted average common shares
outstanding – basic and diluted |
|
50,174,756 |
|
|
44,798,760 |
|
|
49,822,689 |
|
|
44,725,875 |
|
|
Cue Biopharma, Inc. |
Condensed Consolidated Balance Sheets |
(Unaudited, In thousands) |
|
|
|
June 30, 2024 |
|
December 31, 2023 |
Assets |
|
|
|
|
|
|
Cash and cash equivalents |
$ |
30,029 |
|
$ |
48,514 |
|
Other assets |
|
12,300 |
|
|
13,016 |
|
Total assets |
$ |
42,329 |
|
$ |
61,530 |
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
Liabilities |
$ |
20,707 |
|
$ |
24,445 |
|
Stockholders' equity |
|
21,622 |
|
|
37,085 |
|
Total Liabilities and stockholders’ equity |
$ |
42,329 |
|
$ |
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 regarding the potential benefits
and applications of its drug candidates and programs, including the
transformational potential of the company’s Immuno-STAT™ platform
to accomplish its mission of developing breakthrough
immunotherapies to establish a new standard of care in the
treatment of cancer and autoimmune disease; the near-term and
intermediate value creation potential of its autoimmune programs;
the company’s intention to preserve the value of its oncology
programs; the company’s business strategies, plans and prospects,
including those related to the prioritization of CUE-401 and
CUE-501, and the potential benefits of the company’s program
prioritization and realignment on its burn rate; 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,” “promise” 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 ability to shift its focus to its autoimmune assets
and achieve the cost savings that it is projecting; 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
Cue Biopharma (NASDAQ:CUE)
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Cue Biopharma (NASDAQ:CUE)
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