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 directly within the patient’s body, provided a business and
financial update for the second quarter 2023.
Recent Business Highlights
- Presented positive
data update from ongoing Phase 1 trials of CUE-101 for
recurrent/metastatic HPV+ head and neck squamous cell carcinoma at
the 2023 American Society of Clinical Oncology (ASCO) Annual
Meeting held in June.
- Initiated enrollment of the highest dose cohort in CUE-102
Phase 1 monotherapy dose escalation trial focused on Wilms’ Tumor 1
(WT1)-positive recurrent/metastatic gastric, pancreatic, ovarian
and colorectal cancers.
“Our second quarter accomplishments have positioned us well as
we continued to observe both increased durability and depth of
ongoing clinical responses from the CUE-101 combination trial with
pembrolizumab (KEYTRUDA®), which we believe aligns well with our
proposed mechanism of action,” said Daniel Passeri, chief executive
officer of Cue Biopharma. “Importantly, the clinical data to date
and proposed mechanism of action from CUE-101, further supports the
encouraging observations in our ongoing CUE-102 Phase 1 monotherapy
dose escalation trial. Among key accomplishments in the quarter was
the ASCO presentation of CUE-101 demonstrating that CUE-101 appears
to enhance the clinical activity of PD-1 blockade, particularly in
patients with low PD-L1 expression in the tumor, as evidenced by
CPS scores less than 20. CUE-101’s maturing clinical profile from
the ongoing trials, combined with emerging data from our CUE-102
monotherapy dose escalation trial, both of which will be reported
upon at the upcoming Society for Immunotherapy of Cancer's (SITC)
conference in November 2023, provides us with a range of potential
corporate development opportunities and further supports the
potential of our platform for translating the body’s natural
signals (or Nature’s Cues) into protein therapeutics to realize the
full potential of selective modulation of disease specific T
cells.”
Second Quarter 2023 Financial Results The
Company reported collaboration revenue of approximately $1.4
million and $26,000 for the three months ended June 30,
2023 and 2022, respectively. Revenue in the second quarter of 2023
was primarily due to work related to the recent collaboration and
option agreement with Ono Pharmaceutical Co., Ltd.
Research and development expenses were $10.7 million
and $9.6 million for the three months ended June 30,
2023 and 2022, respectively. The increase was due to higher
laboratory and drug substance manufacturing costs in the second
quarter of 2023 as compared to the same period in 2022.
General and administrative expenses were $4.3 million
and $3.8 million for the three months ended June 30,
2023 and 2022, respectively. This increase was due primarily
to higher professional and consulting fees in the second quarter of
2023 as compared to the same period in 2022.
The Company reported collaboration revenue of approximately $1.6
million and $1.0 million for the six months ended June 30, 2023 and
2022, respectively. Revenue for the six months ended June 30, 2023
was primarily due to work related to the recent collaboration and
option agreement with Ono Pharmaceutical Co., Ltd.
Research and development expenses were $20.0 million
and $19.7 million for the six months ended June 30,
2023 and 2022, respectively. This increase was primarily due
to increased clinical costs in 2023 related to the CUE-102 Phase 1
monotherapy dose escalation trial which began enrolling patients in
the second half of 2022.
General and administrative expenses
were $8.4 and $8.9 million for the six months
ended June 30, 2023 and 2022, respectively. This decrease
was primarily due to a decrease in rent and operational expenses
related to the move of our corporate offices.
As of June 30, 2023, the Company had
approximately $57.9 million in cash, cash equivalents and
marketable securities compared with $66.1 million as of
June 30, 2022. We expect our current cash, cash equivalents,
and marketable securities to fund operations through the third
quarter of 2024.
|
Cue Biopharma, Inc. |
Selected Consolidated Statement of Operations and Other
Comprehensive Loss Data |
(In thousands, except share data) |
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
EndedJune 30, |
|
Six Months EndedJune 30, |
|
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
|
Collaboration
revenue |
$ |
1,382 |
|
$ |
26 |
|
$ |
1,570 |
|
$ |
1,026 |
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
General and administrative |
|
4,249 |
|
|
3,782 |
|
|
8,425 |
|
|
8,938 |
|
|
Research and development |
|
10,650 |
|
|
9,592 |
|
|
20,041 |
|
|
19,675 |
|
|
Gain on right-of-use asset termination |
|
|
- |
|
(258 |
) |
|
- |
|
(258 |
) |
|
Total operating expenses |
|
14,899 |
|
|
13,116 |
|
|
28,466 |
|
|
28,355 |
|
|
Loss from
operations |
|
(13,517 |
) |
|
(13,090 |
) |
|
(26,896 |
) |
|
(27,329 |
) |
|
Other income
(expense): |
|
|
|
|
|
|
|
|
|
Interest income |
|
564 |
|
|
88 |
|
|
1,056 |
|
|
96 |
|
|
Interest expense |
|
(232 |
) |
|
(206 |
) |
|
(454 |
) |
|
(230 |
) |
|
Total other income
(expense) |
|
332 |
|
|
(118 |
) |
|
602 |
|
|
(134 |
) |
|
Net loss |
$ |
(13,185 |
) |
$ |
(13,208 |
) |
$ |
(26,294 |
) |
$ |
(27,463 |
) |
|
Unrealized gain from
available-for-sale securities |
|
34 |
|
|
- |
|
|
91 |
|
|
- |
|
|
Comprehensive
loss |
$ |
(13,151 |
) |
$ |
(13,208 |
) |
$ |
(26,203 |
) |
$ |
(27,463 |
) |
|
Net loss per common share – basic
and diluted |
$ |
(0.29 |
) |
$ |
(0.37 |
) |
$ |
(0.59 |
) |
$ |
(0.81 |
) |
|
Weighted average common shares
outstanding – basic and diluted |
|
44,798,760 |
|
|
35,357,343 |
|
|
44,725,875 |
|
|
34,005,410 |
|
|
|
|
Cue Biopharma, Inc. |
Selected Consolidated Balance Sheet Data |
(In thousands) |
|
|
June 30,2023 |
|
June 30,2022 |
Cash and cash equivalents |
|
$ |
52,901 |
|
$ |
66,126 |
Marketable securities |
|
|
4,988 |
|
|
- |
Total current assets |
|
|
60,935 |
|
|
69,004 |
Working capital |
|
|
44,628 |
|
|
60,681 |
Total assets |
|
|
73,163 |
|
|
84,749 |
Total stockholders'
equity |
|
|
46,004 |
|
|
59,756 |
|
|
|
|
|
|
|
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 body’s intrinsic immune system as T cell
engagers without the need for ex vivo manipulation or 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 Twitter
at https://twitter.com/CueBiopharma.
Forward-Looking StatementsThis 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. Such
forward-looking statements include, but are not limited to, those
regarding: the company’s plans to present data from its ongoing
CUE-101 and CUE 102 clinical trials; the company’s belief that the
Immuno-STAT platform stimulates targeted immune modulation through
the selective engagement of disease-relevant T cells; the company’s
business strategies, plans and prospects, including potential
corporate development opportunities; 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 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, 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 the recent COVID-19 pandemic,
including possible effects on the company’s trials; negative or
inconclusive results from the company’s clinical trials or
preclinical studies or serious and unexpected drug-related side
effects or other safety issues experienced by participants in
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; operations and clinical 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 in 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 ContactMaya RomanchuckLifeSci
Communicationsmromanchuck@lifescicomms.com
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