Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology
company developing next-generation immunotherapies that target the
tumor microenvironment, today reported financial results and
corporate highlights for the first quarter 2023, as well as
anticipated near-term milestones.
“We remain highly encouraged by the progress of our two clinical
programs, SRF388 a potential first-in-class IL-27 inhibitor, and
SRF114, a potentially best-in-class anti-CCR8 antibody, both of
which have been enrolling well,” said Rob Ross, M.D., chief
executive officer of Surface. “At the recent AACR Annual Meeting,
we presented compelling new SRF114 preclinical data which indicate
that therapeutic depletion of CCR8 positive tumor infiltrating
Tregs results in robust anti-tumorigenic activity across multiple
tumor models. With respect to SRF388 and our ongoing Phase 2 trials
in liver and lung cancer, we look forward to providing a clinical
data update in both indications later in the second quarter.”
First Quarter and Subsequent Corporate
Highlights
- In April 2023, Surface presented new
preclinical data on SRF114, a fully human anti-CCR8 antibody, at
the American Association for Cancer Research (AACR) Annual Meeting
2023 in Orlando. A poster presentation highlighted new in vivo data
showing SRF114 promotes a pro-inflammatory tumor microenvironment
resulting in robust antitumor activity in checkpoint
inhibition-resistant and checkpoint inhibition-susceptible tumor
models. The poster also demonstrated that anti-CCR8 therapy
resulted in the depletion of Treg cells selectively in tumor tissue
and anti-CCR8 and anti-PD-1 combination therapy increased tumor
immune cell infiltration, cytokine production and improved overall
survival in a checkpoint inhibitor-resistant melanoma model.
- In January 2023, Surface announced
the first patient had been dosed in a Phase 1/2 study evaluating
SRF114 as a monotherapy in patients with advanced solid tumors. The
dose escalation portion of the study is ongoing and will enroll up
to 30 patients evaluating the safety, tolerability,
pharmacokinetics, pharmacodynamics, and preliminary efficacy of
SRF114.
Selected Anticipated Near-term Corporate
Milestones
- In the second quarter, Surface
expects to share updated clinical data from the ongoing Phase 2
studies investigating SRF388 as a monotherapy in lung cancer and in
combination therapy in liver cancer.
- Initial safety and efficacy data
from the ongoing SRF114 Phase 1/2 clinical study are anticipated in
2024.
Financial Results
As of March 31, 2023, cash, cash equivalents and marketable
securities were $102.1 million, compared to $124.8 million on
December 31, 2022.
General and administrative (G&A) expenses were $5.9 million
for the first quarter ended March 31, 2023, compared to $6.5
million for the same period in 2022. The decrease primarily relates
to personnel-related costs from reduced headcount and a reduction
in professional fees. G&A expenses included $1.0 million in
stock-based compensation expense for the first quarter ended
March 31, 2023.
Research and development (R&D) expenses were $13.8 million
for the first quarter ended March 31, 2023, compared to $16.6
million for the same period in 2022. This decrease was primarily
driven by a reduction in manufacturing costs for our SRF388 program
and the strategic decision to pause the SRF617 program as part of
our corporate restructuring in November 2022. R&D expenses
included $0.6 million in stock-based compensation expense for the
first quarter ended March 31, 2023.
For the first quarter ended March 31, 2023, net loss was
$19.7 million, or basic and diluted net loss per share of $0.33.
Net income was $6.2 million for the same period in 2022, or basic
net income per share of $0.13 and diluted net income per share of
$0.13.
Surface Oncology continues to project that current cash and cash
equivalents are sufficient to fund the company into the third
quarter of 2024.
About SRF388
SRF388 is a fully human anti-IL-27 antibody designed to inhibit
the activity of this immunosuppressive cytokine. Surface
Oncology has identified particular tumor types, including
liver and lung cancer, where IL-27 appears to play an important
role in the immunosuppressive tumor microenvironment and may
contribute to resistance to treatment with checkpoint inhibitors.
SRF388 targets the rate-limiting p28 subunit of IL-27, and
preclinical studies have shown that treatment with SRF388 blocks
the immunosuppressive biologic effects of IL-27, resulting in
immune cell activation in combination with other cancer therapies
including anti-PD-1 therapy, as well as potent anti-tumor effects
as a monotherapy. Furthermore, Surface Oncology has
identified a potential biomarker associated with IL-27 that may be
useful in helping to identify patients most likely to respond to
SRF388. In November 2020, Surface announced that SRF388 was
granted Orphan Drug designation and Fast Track designation for the
treatment of refractory hepatocellular carcinoma from the FDA.
About SRF114
SRF114 is a fully human, afucosylated anti-CCR8 antibody
designed to preferentially deplete CCR8+ Treg cells within the
tumor microenvironment. In preclinical studies, Surface
Oncology has shown that SRF114 induces antibody-dependent
cellular cytotoxicity (ADCC) and/or antibody-dependent cellular
phagocytosis (ADCP) pathways to deplete intratumoral Treg cells. In
addition, SRF114 reduced tumor growth in murine models. These
findings support the advancement of SRF114 as a therapeutic
candidate that holds the potential to drive anti-tumor immunity in
patients.
About Surface Oncology
Surface Oncology is an immuno-oncology company developing
next-generation antibody therapies focused on the tumor
microenvironment. Its pipeline includes two wholly-owned programs;
SRF388, a Phase 2 program which targets IL-27, and SRF114, a Phase
1 program, which selectively depletes regulatory T cells in the
tumor microenvironment via targeting CCR8. In addition, Surface has
two partnerships with major pharmaceutical companies: a
collaboration with Novartis targeting CD73 (NZV930; Phase 1) and a
collaboration with GlaxoSmithKline targeting PVRIG (GSK4381562,
formerly SRF813; Phase 1). Surface’s novel, investigational cancer
immunotherapies are designed to achieve a clinically meaningful and
sustained anti-tumor response and may be used alone or in
combination with other therapies. For more information, please
visit www.surfaceoncology.com.
Cautionary Note Regarding Forward-Looking
Statements
Certain statements set forth in this press release constitute
“forward-looking” statements within the meaning of the Private
Securities Litigation Reform Act of 1995, as amended.
Forward-looking statements can be identified by terms such as
“believes,” “expects,” “plans,” “potential,” “would” or similar
expressions, and the negative of those terms. These forward-looking
statements are based on Surface Oncology’s management’s current
beliefs and assumptions about future events and on information
currently available to management.
Forward-looking statements involve known and unknown risks,
uncertainties and other factors that may cause Surface Oncology’s
actual results, performance or achievements to be materially
different from any future results, performance or achievements
expressed or implied by the forward-looking statements. These risks
include, but are not limited to, risks and uncertainties related to
Surface Oncology’s ability to successfully develop SRF388, SRF114
and its other product candidates through current and future
milestones or regulatory filings on the anticipated timeline, if at
all, the therapeutic potential of Surface Oncology’s product
candidates, the risk that results from preclinical studies or early
clinical trials may not be representative of larger clinical
trials, the risk that Surface Oncology’s product candidates,
including SRF388, SRF617 and SRF114, will not be successfully
developed or commercialized either by Surface Oncology or in
collaboration with third parties, and the risks related to Surface
Oncology’s dependence on third parties in connection with its
manufacturing, clinical trials and preclinical studies. Additional
risks and uncertainties that could affect Surface Oncology’s future
results are included in the section titled “Risk Factors” in our
Annual Report on Form 10-K for the year ending December 31, 2022,
available on the Securities and Exchange Commission’s website at
www.sec.gov and Surface Oncology’s website at
www.surfaceoncology.com. Additional information on potential risks
will be made available in other filings that Surface Oncology makes
from time to time with the Securities and Exchange Commission. In
addition, any forward-looking statements contained in this press
release are based on assumptions that Surface Oncology believes to
be reasonable as of this date. Except as required by law, Surface
Oncology assumes no obligation to update these forward-looking
statements, or to update the reasons if actual results differ
materially from those anticipated in the forward-looking
statements.
Contact
Scott Young(617) 865-3250syoung@surfaceoncology.com
|
Selected Financial Information(In thousands,
except share and per share amounts)(Unaudited) |
|
|
Three months ended March 31, |
Statement of Operations Items |
|
2023 |
|
|
|
2022 |
|
License-related revenue |
$ |
— |
|
|
$ |
30,000 |
|
Operating expenses: |
|
|
|
Research and development |
|
13,777 |
|
|
|
16,624 |
|
General and administrative |
|
5,886 |
|
|
|
6,540 |
|
Total operating expenses |
|
19,663 |
|
|
|
23,164 |
|
Income (loss) from
operations |
|
(19,663 |
) |
|
|
6,836 |
|
Interest and other expense,
net |
|
(78 |
) |
|
|
(637 |
) |
Net income (loss) |
|
(19,741 |
) |
|
|
6,199 |
|
Net income (loss) per share —
basic |
$ |
(0.33 |
) |
|
$ |
0.13 |
|
Weighted average common shares
outstanding — basic |
|
60,627,993 |
|
|
|
48,606,055 |
|
Net income (loss) per share —
diluted |
$ |
(0.33 |
) |
|
$ |
0.13 |
|
Weighted average common shares
outstanding — diluted |
|
60,627,993 |
|
|
|
49,816,784 |
|
|
Selected Balance Sheet
Items: |
March 31, 2023 |
|
December 31, 2022 |
Cash, cash equivalents and marketable securities |
$ |
102,055 |
|
$ |
124,823 |
Total assets |
|
137,008 |
|
|
159,910 |
Accounts payable and accrued
expenses |
|
5,720 |
|
|
10,470 |
Total stockholders’
equity |
|
75,831 |
|
|
93,403 |
Surface Oncology (NASDAQ:SURF)
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Surface Oncology (NASDAQ:SURF)
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