- Partner CSPC Pharmaceutical Group Limited's ongoing Phase
1 SYSA1801 (EO-3021) clinical trial data selected for poster
presentation and poster discussion at ASCO 2023
- Presented EO-3021 preclinical proof-of-concept data at AACR
2023 which demonstrated anti-tumor activity in models expressing
varying levels of Claudin 18.2; clinical case study highlighted
SYSA1801 (EO-3021) induced a confirmed partial response in a
patient with metastatic gastric cancer
NEW
YORK, May 15, 2023 /PRNewswire/ -- Elevation
Oncology, Inc. (Nasdaq: ELEV), an innovative oncology company
focused on the discovery and development of selective cancer
therapies to treat patients across a range of solid tumors with
significant unmet medical needs, today announced financial results
for the quarter ended March 31, 2023,
and highlighted recent business achievements.
"Throughout the first quarter of 2023, we made significant
progress as a company. Most recently, we presented preclinical data
for our lead candidate, EO-3021, demonstrating anti-tumor activity
in preclinical models expressing varying levels of Claudin 18.2,
and highlighted a clinical case study showing EO-3021 induced
a confirmed partial response in a patient with metastatic
gastric cancer," said Joseph Ferra, Interim Chief Executive
Officer of Elevation Oncology. "This is an exciting time for
us as we and our partner, CSPC Pharmaceutical Group Limited, embark
on sharing initial clinical data from the ongoing Phase 1 study of
EO-3021 at ASCO 2023. In addition, we remain on track to initiate
our Phase 1 trial evaluating EO-3021 in the US in the second half
of 2023."
Recent Business Achievements
EO-3021
- Presented preclinical proof-of-concept data at AACR
2023. Key preclinical findings included demonstrating
anti-tumor activity in preclinical xenograft models of pancreatic
and gastric cancers expressing varying levels of Claudin 18.2. A
single-dose of EO-3021 demonstrated tumor regression across low,
medium, and high Claudin 18.2-expressing models, with a lower
minimal efficacious dose in models with medium and high levels of
Claudin 18.2 relative to models with low levels of Claudin 18.2.
EO-3021 also outperformed standard of care chemotherapy in gastric
and pancreatic cancer preclinical xenograft models.
- Highlighted clinical case study of EO-3021 at AACR 2023.
A clinical case study of a patient with metastatic gastric cancer
in an ongoing Phase 1 clinical trial of SYSA1801 (EO-3021) in
China (NCT05009966) conducted by
CSPC Pharmaceutical Group Limited (HKEX: 01093) was also
highlighted. The patient was treated with dose level 2, or 1.0mg/kg
EO-3021, intravenously, every three weeks (treatment ongoing). The
best overall response, as evaluated per RECIST v1.1, was a
confirmed partial response (66.7% maximal tumor reduction), while
the duration of response was approximately 11 months and
ongoing.
- SYSA1801 (EO-3021) Phase 1 data selected for presentation at
ASCO 2023. An abstract featuring SYSA1801 (EO-3021) Phase 1
clinical data has been selected for a poster presentation and
poster discussion at the upcoming American Society of Clinical
Oncology (ASCO) 2023 Annual Meeting, being held June 2-6, 2023, in Chicago, IL. The ongoing Phase 1 dose
escalation and dose expansion study is evaluating SYSA1801 in
patients with Claudin 18.2-positive advanced solid tumors and is
being conducted in China by
Elevation Oncology's partner, CSPC Pharmaceutical Group Limited
(CSPC; HKEX: 01093).
Other Pipeline Programs
- Continue research and development efforts to advance novel
therapeutic drug candidates and targets. Additional pipeline
programs include those through its existing partnership with Caris
Life Sciences.
Expected Upcoming Milestones and Operational
Objectives
- Initiate Phase 1 clinical trial of EO-3021 in the US in the
second half of 2023
- Ongoing target evaluation for future pipeline expansion
First Quarter 2023 Financial Results
As of March 31, 2022, the Company had cash, cash
equivalents and marketable securities totaling $73.9 million,
compared to $90.3 million as of
December 31, 2022.
Research and development expenses for the first quarter 2023
were $7.3 million, compared to
$13.6 million for the first quarter
2022. The decrease in R&D expense in the first quarter of 2023
was primarily related to the decrease in costs related to
manufacturing clinical supply of seribantumab for use in the
CRESTONE clinical trial. The Company prioritized its pipeline and
realigned resources to advance its EO-3021 product candidate.
General and administrative expenses for the first quarter 2023
were $4.3 million, compared to
$3.8 million for the first quarter
2022. The increase in G&A expense in the first quarter of 2023
was primarily related to increases in personnel costs, professional
services and other administrative costs.
Restructuring charges were $5.1
million for the first quarter 2023, and consisted primarily
of one-time charges related to the pipeline prioritization and
realignment of resources to advance our EO-3021 product candidate,
including $1.6 million of termination
and contractual termination benefits for severance, healthcare and
related benefits.
Net loss for the first quarter 2023 was $17.1 million, compared to $17.3 million for the first quarter 2022.
About EO-3021
EO-3021 (also known as SYSA1801) is a differentiated,
clinical-stage antibody drug conjugate (ADC) comprised of an
immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that targets
Claudin 18.2 and is site-specifically conjugated to the monomethyl
auristatin E (MMAE) payload via a cleavable linker with a
drug-to-antibody ratio (DAR) of 2. Claudin 18.2 is a specific
isoform of Claudin 18 that is only expressed in gastric epithelial
cells. During malignant transformation of gastric cancer, the tight
junctions may become disrupted, exposing Claudin 18.2 and allowing
them to be accessible by Claudin 18.2 targeting agents. Claudin
18.2 can also be expressed in other solids tumors. An
Investigational New Drug application for EO-3021 has been cleared
by the U.S. Food and Drug Administration.
About Elevation Oncology, Inc.
Elevation Oncology is an innovative oncology company focused on
the discovery and development of selective cancer therapies to
treat patients across a range of solid tumors with significant
unmet medical needs. We are rethinking drug development by seeking
out innovative, selective cancer therapies that can be matched to a
patient's unique tumor characteristics. Our lead candidate,
EO-3021, is a potential best-in-class antibody drug conjugate (ADC)
designed to target Claudin 18.2, a clinically validated molecular
target. EO-3021 selectively delivers a cytotoxic payload directly
to cancer cells expressing Claudin 18.2. We are working to rapidly
advance EO-3021 into the clinic in the US across a range of solid
tumor indications, as well as exploring other opportunities through
new or existing partnerships and business development opportunities
to expand our novel oncology pipeline. For more information,
visit www.ElevationOncology.com.
Forward Looking Statements
This press release contains forward-looking statements within
the meaning of the "safe harbor" provisions of the Private
Securities Litigation Reform Act of 1995, including, but not
limited to, anticipated preclinical and clinical development
activities, expected timing of announcements of clinical results,
potential benefits of Elevation Oncology's product candidates,
potential market opportunities for Elevation Oncology's product
candidates, the ability of Elevation Oncology's product candidates
to treat their targeted indications and Elevation Oncology's
expectations about its cash runway. All statements other than
statements of historical fact are statements that could be deemed
forward-looking statements. These forward-looking statements may be
accompanied by such words as "aim," "anticipate," "believe,"
"could," "estimate," "expect," "forecast," "goal," "intend," "may,"
"might," "plan," "potential," "possible," "will," "would," and
other words and terms of similar meaning. Although Elevation
Oncology believes that the expectations reflected in such
forward-looking statements are reasonable, Elevation Oncology
cannot guarantee future events, results, actions, levels of
activity, performance or achievements, and the timing and results
of biotechnology development and potential regulatory approval are
inherently uncertain. Forward-looking statements are subject to
risks and uncertainties that may cause Elevation Oncology's actual
activities or results to differ significantly from those expressed
in any forward-looking statement, including risks and uncertainties
related to Elevation Oncology's ability to advance its product
candidates, the timing and results of preclinical studies and
clinical trials, approvals and commercialization of product
candidates, the receipt and timing of potential regulatory
designations, the impact of the continued presence of COVID-19 on
Elevation Oncology's business, Elevation Oncology's ability to fund
development activities and achieve development goals, Elevation
Oncology's ability to protect intellectual property, Elevation
Oncology's ability to establish and maintain collaborations with
third parties, and other risks and uncertainties described under
the heading "Risk Factors" in documents Elevation Oncology files
from time to time with the Securities and Exchange Commission.
These forward-looking statements speak only as of the date of this
press release, and Elevation Oncology undertakes no obligation to
revise or update any forward-looking statements to reflect events
or circumstances after the date hereof.
Elevation Oncology Investor and Media
Contact
Candice Masse,
978-879-7273
Senior Director, Corporate Communications & Investor
Relations
Cmasse@elevationoncology.com
Selected Financial
Information
(In thousands,
except share and per share data)
(unaudited)
|
|
|
|
Three months ended
March 31,
|
|
|
2023
|
|
2022
|
Operating
expenses:
|
|
|
|
|
|
|
Research and
development
|
|
$
|
7,292
|
|
$
|
13,575
|
General and
administrative
|
|
|
4,346
|
|
|
3,793
|
Restructuring
charges
|
|
|
5,107
|
|
|
—
|
Total operating
expenses
|
|
|
16,745
|
|
|
17,368
|
Loss from
operations
|
|
|
(16,745)
|
|
|
(17,368)
|
Other income (expense),
net
|
|
|
(309)
|
|
|
93
|
Loss before income
taxes
|
|
|
(17,054)
|
|
|
(17,275)
|
Income tax
expense
|
|
|
5
|
|
|
—
|
Net loss
|
|
$
|
(17,059)
|
|
$
|
(17,275)
|
Net loss per share,
basic and diluted
|
|
$
|
(0.72)
|
|
$
|
(0.74)
|
Weighted average common
shares outstanding, basic and diluted
|
|
|
23,618,559
|
|
|
23,216,206
|
|
|
|
|
|
|
|
Comprehensive
loss:
|
|
|
|
|
|
|
Net loss
|
|
$
|
(17,059)
|
|
$
|
(17,275)
|
Other comprehensive
gain (loss):
|
|
|
|
|
|
|
Unrealized gain (loss)
on marketable securities
|
|
|
110
|
|
|
(204)
|
Total other
comprehensive gain (loss)
|
|
$
|
110
|
|
$
|
(204)
|
Total comprehensive
loss
|
|
$
|
(16,949)
|
|
$
|
(17,479)
|
Selected Financial
Information (In thousands, except share and per share
data) (unaudited)
|
|
|
March 31,
|
December 31,
|
Selected Balance
Sheet items (in thousands):
|
2023
|
2022
|
Cash, cash equivalents
and marketable securities
|
$ 73,929
|
$ 90,280
|
Prepaid expenses and
other current assets
|
1,906
|
2,697
|
Working
Capital1
|
62,301
|
77,285
|
Total Assets
|
76,898
|
94,161
|
Long-term debt, net of
discount
|
29,600
|
29,435
|
Total Stockholders'
Equity
|
33,764
|
49,032
|
1 We Define Working Capital As Current Assets less Current
Liabilities.
|
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SOURCE Elevation Oncology