Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage
biopharmaceutical company developing a novel class of T cell
engagers to selectively modulate tumor-specific T cells, provided a
business and financial update for the third quarter of 2023.
Recent Business Highlights
- Presented positive data from ongoing Phase 1 trials of CUE-101
and CUE-102 at the Society for Immunotherapy of Cancer’s 38th
Anniversary Annual Meeting (SITC 2023) held November 1-5.
- Updated Phase 1 data of CUE-101 monotherapy for second line
(2L) and beyond recurrent/metastatic HPV+ head and neck squamous
cell carcinoma demonstrating an estimated median overall survival
(mOS) of 20.8 months compared with the historical mOS of 8.4 months
for KEYTRUDA® (pembrolizumab) observed in Merck’s KEYNOTE-040
trial.
- Completed enrollment of 20 patients for the ongoing Phase 1b
study of CUE-101 in combination with pembrolizumab. Of 17 evaluable
patients at the September 27 SITC data cutoff, an overall response
rate (ORR) of 47% was reported for CUE-101 + pembrolizumab vs. 19%
historic ORR for pembrolizumab alone in Merck’s KEYNOTE-048 trial,
with median progression free survival (mPFS) and mOS still maturing
and trending positively. In patients with low levels of PD-L1
expression in the tumor tissue that are historically low responders
to anti-PD-1 therapy, CUE-101 + pembrolizumab demonstrated an ORR
of 56% vs. 14.5% for pembrolizumab alone.
- Reported initial data from CUE-102 Phase 1 monotherapy trial
for the treatment of Wilms’ Tumor 1 (WT1)-expressing tumors with
early observations of anti-tumor activity and tolerability.
- Demonstrated disease control rate (DCR) of 75% and 80% at the
4mg/kg and 2mg/kg doses of CUE-102 respectively and observed tumor
reductions of -30% and -29% in two patients, one with gastric
cancer and one with ovarian cancer.
- Advanced preclinical programs from the CUE-100 series including
additional alleles, such as A11, A24 and A03 and tumor epitopes,
such as KRAS and MAGE A4, as well as CUE-401 in collaboration with
Ono Pharmaceutical.
“The continued advancements of our programs and
platform have positioned us as a potential industry- leading
solutions provider for immuno-oncology and autoimmune disease,”
said Daniel Passeri, chief executive officer of Cue Biopharma.
“Importantly, we believe the positive data from our ongoing
clinical trials has placed us in a sound position to continue
developing our platform for selective and targeted modulation of
disease relevant T cells in broader applications across many
cancers and autoimmune diseases.”
Third Quarter 2023 Financial
Results The Company reported collaboration revenue
of approximately $2.1 million and $68,000 for the three
months ended September 30, 2023 and 2022, respectively.
Revenue in the third 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 $9.9 million and $7.6 million for the
three months ended September 30, 2023 and 2022, respectively.
The increase was due to higher clinical expenses, stock-based
compensation and research and laboratory expenses in the third
quarter of 2023 as compared to the same period in 2022.
General and administrative expenses remained steady
at $3.6 million and 3.5 million for the three months
ended September 30, 2023 and 2022, respectively.
The Company reported collaboration revenue of
approximately $3.7 million and $1.1 million for the nine months
ended September 30, 2023 and 2022, respectively. Revenue for the
nine months ended September 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 $30.0 million and $27.2 million for the
nine months ended September 30, 2023 and 2022, respectively.
This increase was primarily due to increased clinical costs in 2023
related to the initiation of the Phase 1 monotherapy clinical trial
of CUE-102.
General and administrative expenses
were $12.1 million and $12.5 million for the
nine months ended September 30, 2023 and 2022,
respectively. This decrease was primarily due to lower stock-based
compensation for executive management.
As of September 30, 2023, the Company had
approximately $54.7 million in cash and cash equivalents
compared with $76.3 million in cash, cash equivalents and
marketable securities as of December 31, 2022. We expect our
current cash and cash equivalents to fund operations through
2024.
Cue Biopharma,
Inc.Selected Consolidated Statement of Operations
and Other Comprehensive Loss Data(In thousands,
except share data)
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Three Months
EndedSeptember 30, |
|
|
Nine Months EndedSeptember
30, |
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2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
Collaboration revenue |
$ |
2,100 |
|
|
$ |
68 |
|
|
$ |
3,669 |
|
|
$ |
1,094 |
|
Operating expenses: |
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General and administrative |
|
3,645 |
|
|
|
3,528 |
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|
|
12,071 |
|
|
|
12,465 |
|
Research and development |
|
9,874 |
|
|
|
7,571 |
|
|
|
29,915 |
|
|
|
27,246 |
|
Gain on right-of-use asset termination |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(258 |
) |
Total operating expenses |
|
13,519 |
|
|
|
11,009 |
|
|
|
41,986 |
|
|
|
39,453 |
|
Loss from operations |
|
(11,419 |
) |
|
|
(11,031 |
) |
|
|
(38,317 |
) |
|
|
(38,359 |
) |
Other income (expense): |
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Interest income |
|
700 |
|
|
|
200 |
|
|
|
1,756 |
|
|
|
296 |
|
Interest expense |
|
(286 |
) |
|
|
(124 |
) |
|
|
(738 |
) |
|
|
(355 |
) |
Total other income (expense) |
|
414 |
|
|
|
76 |
|
|
|
1,018 |
|
|
|
(59 |
) |
Net loss |
$ |
(11,005 |
) |
|
$ |
(10,955 |
) |
|
$ |
(37,299 |
) |
|
$ |
(38,418 |
) |
Unrealized gain (loss) from available-for-sale securities |
|
5 |
|
|
|
(92 |
) |
|
|
96 |
|
|
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(92 |
) |
Comprehensive loss |
$ |
(11,000 |
) |
|
$ |
(11,047 |
) |
|
$ |
(37,203 |
) |
|
$ |
(38,510 |
) |
Net loss per common share – basic and diluted |
$ |
(0.24 |
) |
|
$ |
(0.31 |
) |
|
$ |
(0.82 |
) |
|
$ |
(1.11 |
) |
Weighted average common shares outstanding – basic and
diluted |
|
46,358,555 |
|
|
|
35,383,430 |
|
|
|
45,274,124 |
|
|
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34,471,499 |
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Cue Biopharma,
Inc.Selected Consolidated Balance Sheet
Data(In thousands)
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September 30,
2023 |
|
|
December 31,2022 |
Cash and cash equivalents |
$ |
54,691 |
|
$ |
51,614 |
Marketable securities |
|
- |
|
|
24,675 |
Total current assets |
|
57,517 |
|
|
77,187 |
Working capital |
|
40,310 |
|
|
65,639 |
Total assets |
|
68,888 |
|
|
91,283 |
Total stockholders'
equity |
|
42,666 |
|
|
65,683 |
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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 belief that the
Immuno-STAT platform stimulates targeted immune modulation through
the selective engagement of disease-relevant T cell and the
applicability of the company’s platform across many cancers and
autoimmune diseases; the company’s business strategies, plans and
prospects, including potential corporate development and
partnership 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
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 the recent COVID-19 pandemic, including
possible effects on the company’s 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; 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 RomanchukLifeSci
Communicationsmromanchuk@lifescicomms.com
Cue Biopharma (NASDAQ:CUE)
過去 株価チャート
から 5 2024 まで 6 2024
Cue Biopharma (NASDAQ:CUE)
過去 株価チャート
から 6 2023 まで 6 2024