-- Enrollment is ongoing in the Phase 1
clinical trial evaluating EO-3021 in patients with advanced solid
tumors likely to express Claudin 18.2; preliminary safety and
anti-tumor activity data expected in 1H 2025 --
BOSTON, Nov. 2, 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 third quarter ended
September 30, 2023, and highlighted
recent business achievements.
"In the third quarter, we achieved a key milestone in our
efforts to establish EO-3021 as a potential best-in-class
anti-Claudin 18.2 ADC therapy, initiating patient enrollment in our
Phase 1 clinical trial," said Joseph
Ferra, President and Chief Executive Officer of Elevation
Oncology. "Claudin 18.2 is a validated target, expressed at varying
levels in solid tumor types that affect millions of patients
globally. As an ADC, EO-3021 is uniquely positioned to address a
broad population by targeting tumors that express varying levels of
Claudin 18.2, which may be inaccessible to other therapeutic
approaches, while also potentially delivering improved efficacy and
tolerability. As demonstrated by initial clinical data from our
partner in China, we believe
EO-3021 could deliver an important treatment option for
patients."
Recent Business Achievements
In August 2023, Elevation Oncology
began enrolling patients in its Phase 1 clinical trial of EO-3021
(NCT05980416). The Phase 1 clinical trial is an open-label,
multi-center, dose escalation and expansion study designed to
evaluate the safety, tolerability and preliminary anti-tumor
activity of EO-3021 in patients with advanced, unresectable or
metastatic solid tumors likely to express Claudin 18.2, including
gastric, gastroesophageal junction, pancreatic or esophageal
cancers. An additional objective of the study is to assess the
association of Claudin 18.2 expression and objective response.
Elevation Oncology expects to report preliminary safety and
anti-tumor activity data during the first half of 2025.
Third Quarter 2023 Financial Results
As of September 30, 2023,
Elevation Oncology had cash, cash equivalents and marketable
securities totaling $94.8 million,
compared to $90.3 million as of
December 31, 2022. The increase in
cash reflects net proceeds of approximately $46.5 million from Elevation Oncology's
underwritten public offering, which closed in June 2023, partially offset by cash used to fund
operating activities.
Research and development (R&D) expenses for the third
quarter 2023 were $7.4 million,
compared to $34.3 million for the
third quarter 2022. The decrease in R&D expenses in the third
quarter of 2023 was primarily due to the cost related to the
license agreement between Elevation Oncology and a subsidiary of
CSPC Pharmaceutical Group Limited for rights to develop and
commercialize EO-3021, which was recorded in the third quarter of
2022.
General and administrative (G&A) expenses for the third
quarter 2023 were $3.5 million,
compared to $4.2 million for the
third quarter 2022. The decrease in G&A expenses in the third
quarter of 2023 was primarily due to a decrease in administrative
costs, including directors' and officers' insurance.
Net loss for the third quarter 2023 was $10.6 million, compared to $38.8 million for the third quarter 2022.
Financial Outlook
Elevation Oncology expects its existing cash, cash equivalents
and marketable securities as of September
30, 2023, to be sufficient to fund its current operations
into the second half of 2025.
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. EO-3021is 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 normally expressed in gastric
epithelial cells. During malignant transformations, the tight
junctions may become disrupted, exposing Claudin 18.2 and allowing
them to be accessible by Claudin 18.2 targeting agents. Elevation
Oncology is evaluating EO-3021 in a Phase 1 study
(NCT05980416) in patients with advanced, unresectable or
metastatic solid tumors likely to express Claudin 18.2 including
gastric, gastroesophageal junction, pancreatic or esophageal
cancers.
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 evaluating EO-3021
in a Phase 1 study in patients with advanced, unresectable or
metastatic solid tumors likely to express Claudin 18.2 including
gastric, gastroesophageal, pancreatic or esophageal cancers. We are
also exploring other opportunities through new or existing
partnerships and business development opportunities to expand our
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 clinical development activities, potential
benefits of Elevation Oncology's product candidates, potential
market opportunities for Elevation Oncology's product candidates,
and the ability of Elevation Oncology's product candidates to treat
their targeted indications. 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
|
|
Results of
Operations (unaudited)
|
|
|
|
|
|
|
|
|
Three months ended
September 30,
|
(In thousands,
except share and per-share amounts)
|
|
2023
|
|
2022
|
Operating
expenses:
|
|
|
|
|
|
|
Research and
development
|
|
$
|
7,422
|
|
$
|
34,340
|
General and
administrative
|
|
|
3,498
|
|
|
4,191
|
Total operating
expenses
|
|
|
10,920
|
|
|
38,531
|
Loss from
operations
|
|
|
(10,920)
|
|
|
(38,531)
|
Other income (expense),
net
|
|
|
295
|
|
|
(306)
|
Loss before income
taxes
|
|
|
(10,625)
|
|
|
(38,837)
|
Income tax
expense
|
|
|
11
|
|
|
—
|
Net loss
|
|
|
(10,636)
|
|
|
(38,837)
|
Net loss per share,
basic and diluted
|
|
$
|
(0.25)
|
|
$
|
(1.67)
|
Weighted average common
shares outstanding, basic and diluted
|
|
|
42,402,489
|
|
|
23,290,249
|
Selected Financial
Information
|
|
Consolidated Balance
Sheets (unaudited)
|
|
|
|
September 30,
|
December 31,
|
(in
thousands):
|
2023
|
2022
|
Cash, cash equivalents
and marketable securities
|
$ 94,797
|
$ 90,280
|
|
|
|
Prepaid expenses and
other current assets
|
4,000
|
2,697
|
|
|
|
Working
Capital1
|
91,190
|
77,285
|
|
|
|
Total Assets
|
99,975
|
94,161
|
|
|
|
Long-term debt, net of
discount
|
29,952
|
29,435
|
|
|
|
Total Stockholders'
Equity
|
62,416
|
49,032
|
|
1 We
define working capital as current assets less current
liabilities.
|
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SOURCE Elevation Oncology