-- Enrollment ongoing in Phase 1 clinical
trial of EO-3021 in the U.S. and Japan; expect to announce initial safety and
efficacy data by mid-3Q 2024, with additional data in 1H 2025
--
-- Presented preclinical proof-of-concept data
for HER3-ADC program at AACR Annual Meeting; on-track to
nominate development candidate in 2H 2024 --
-- Raised $44.2
million year-to-date through ATM facility, extending cash
runway into 2026 --
BOSTON, May 2, 2024
/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, 2024, and highlighted recent business
achievements.
"In recent months, we focused on advancing our growing pipeline
of differentiated ADCs, each with broad therapeutic potential, and
extending our cash runway into 2026, beyond upcoming milestones for
EO-3021 and our HER3-ADC program," said Joseph Ferra, President and Chief Executive
Officer of Elevation Oncology. "At AACR, we shared preclinical
proof-of-concept data from our HER3-ADC program, demonstrating
HER3-dependent cell killing and robust anti-tumor activity. These
data support continued development of our HER3-ADC program, and we
look forward to nominating a development candidate later this
year."
Mr. Ferra continued, "In parallel, we continue to enroll
patients in our Phase 1 clinical trial of EO-3021 in the U.S. and
Japan. We remain on track to share
details of our planned EO-3021 combination study in the first half
of 2024, as well as initial safety and efficacy data from our
ongoing trial by mid-third quarter, as we work to change the
treatment paradigm for patients living with Claudin 18.2-expressing
tumors, who are in significant need of new therapeutic
options."
Recent Business Achievements
- In April 2024, Elevation Oncology
presented preclinical proof-of-concept data from its HER3-ADC
program at the American Association for Cancer Research (AACR)
Annual Meeting. The data showed HER3-dependent cell killing and
robust anti-tumor activity in a patient-derived xenograft model of
pancreatic cancer with high HER3 expression, highlighting the
therapeutic potential of Elevation Oncology's HER3-ADC program
across a range of HER3-expressing cancers.
Expected Upcoming Milestones
EO-3021:
- Share details on planned Phase 1 combination study evaluating
EO-3021 in the first half of 2024.
- Provide update from ongoing Phase 1 clinical trial of EO-3021
at a corporate event by mid-third quarter 2024, including initial
safety and efficacy data from at least three dose cohorts.
- Additional data expected in the first half of 2025.
HER3-ADC:
- Nominate development candidate from HER3-ADC program in the
second half of 2024.
First Quarter 2024 Financial Results
As of March 31, 2024, the Company
had cash, cash equivalents and marketable securities totaling
$104.1 million, compared to
$83.1 million as of December 31, 2023. The increase in cash reflects
net proceeds of $29.7 million, which
Elevation Oncology raised through its at-the-market (ATM) facility
in the first quarter of 2024, partially offset by cash used to fund
operating activities. Subsequent to the first quarter of 2024,
Elevation Oncology raised an additional $14.5 million through its ATM facility.
Research and development (R&D) expenses for the first
quarter of 2024 were $6.0 million,
compared to $7.3 million for the
first quarter 2023. The decrease in R&D expenses in the first
quarter of 2024 was primarily due to decreased clinical trial
expenses associated with Elevation Oncology's former lead program,
partially offset by increased clinical trial expenses associated
with the ongoing EO-3021 Phase 1 trial.
General and administrative (G&A) expenses for the first
quarter of 2024 were $3.9 million,
compared to $4.3 million for the
first quarter 2023. The decrease in G&A expenses in the first
quarter of 2024 was primarily due to decreased administrative
costs, including directors' and officers' insurance, and decreased
personnel costs, including stock-based compensation.
Net loss for the first quarter of 2024 was $10.7 million, compared to $17.1 million for the first quarter of 2023.
Financial Outlook
Elevation Oncology expects its existing cash, cash equivalents
and marketable securities as of March 31,
2024, together with the $14.5
million in net proceeds raised under its ATM facility
subsequent to the first quarter of 2024, to be sufficient to fund
its current operations into 2026.
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 leveraging our antibody-drug conjugate
(ADC) expertise to advance a novel pipeline, initially targeting
two clinically validated targets in oncology, Claudin 18.2 and
HER3. Our lead candidate, EO-3021, is a potential best-in-class ADC
designed to target Claudin 18.2 and is currently being evaluated in
a Phase 1 trial (NCT05980416) in patients with advanced,
unresectable or metastatic solid tumors likely to express Claudin
18.2 including gastric, gastroesophageal junction, pancreatic or
esophageal cancers. Additionally, we expect to nominate a
development candidate for our second program, a HER3-targeting ADC
for the treatment of patients with solid tumors that overexpress
HER3, in 2024. 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 and preclinical development
activities, expected timing of announcements of clinical and
preclinical results and trial details, 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,"
"possible," "potential," "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, 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 Contact
Hannah Deresiewicz,
212-362-1200
EVP, Managing Director, Stern Investor Relations, Inc.
hannah.deresiewicz@sternir.com
Selected Financial
Information
|
(In thousands,
except share and per share data)
|
(unaudited)
|
|
|
|
Three months ended
March 31,
|
|
|
2024
|
|
2023
|
Statement of
Operations items:
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
Research and
development
|
|
$
|
6,011
|
|
$
|
7,292
|
General and
administrative
|
|
|
3,858
|
|
|
4,346
|
Restructuring
charges
|
|
|
—
|
|
|
5,107
|
Total operating
expenses
|
|
|
9,869
|
|
|
16,745
|
Loss from
operations
|
|
|
(9,869)
|
|
|
(16,745)
|
Other income
(expense):
|
|
|
|
|
|
|
Interest income
(expense), net
|
|
|
115
|
|
|
(309)
|
Loss on extinguishment
of debt
|
|
|
(942)
|
|
|
—
|
Total other income
(expense), net
|
|
|
(827)
|
|
|
(309)
|
Loss before income
taxes
|
|
|
(10,696)
|
|
|
(17,054)
|
Income tax
expense
|
|
|
11
|
|
|
5
|
Net loss
|
|
$
|
(10,707)
|
|
$
|
(17,059)
|
Net loss per share,
basic and diluted
|
|
$
|
(0.23)
|
|
$
|
(0.72)
|
Weighted average common
shares outstanding, basic and diluted
|
|
|
47,371,882
|
|
|
23,618,559
|
Selected Financial
Information
|
(In thousands,
except share and per share data)
|
(unaudited)
|
|
|
|
|
|
|
Selected Balance
Sheet items:
|
|
March 31,
2024
|
|
December 31,
2023
|
Cash, cash equivalents
and marketable securities
|
|
$
|
104,051
|
|
$
|
83,107
|
Working
capital1
|
|
|
105,553
|
|
|
83,819
|
Total assets
|
|
|
108,961
|
|
|
89,091
|
Long-term debt, net of
discount
|
|
|
30,809
|
|
|
30,137
|
Total stockholders'
equity
|
|
|
75,818
|
|
|
54,809
|
|
1 We
define working capital as current assets less current
liabilities.
|
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SOURCE Elevation Oncology