NEW YORK, Nov. 12, 2021 /PRNewswire/ -- Elevation Oncology,
Inc. (Nasdaq: ELEV), a clinical stage biopharmaceutical company
focused on the development of precision medicines for patients with
genomically defined cancers, today announced financial results for
the quarter ended September 30,
2021.
"The third quarter was marked by continued progress on our
mission to bring purpose-built medicines to patients with
genomically defined cancers," said Shawn M. Leland, PharmD,
RPh, Founder and Chief Executive Officer of Elevation Oncology.
"The CRESTONE Study is now open and enrolling patients in the US,
Canada, and Australia. Our collaboration with Caris Life
Sciences is revealing a series of potential programs targeting
genomic fusions. Finally, I am also pleased to welcome Valerie Malyvanh Jansen, MD, PhD, as our first
Chief Medical Officer."
"We are encouraged by the durable clinical benefit seen with
seribantumab in the case study of a patient with metastatic
pancreatic cancer harboring an NRG1 fusion that was presented at
the Australasian Gastro-Intestinal Cancer Trials Group conference,"
said Dr. Jansen. "Separately, we expect to complete enrollment of
the first 20 patients in Cohort 1 of CRESTONE in mid-2022. We also
anticipate presenting initial clinical data at a major medical
meeting in mid-2022, which will include results from approximately
10 patients from Cohort 1 with meaningful follow-up who have been
treated with seribantumab at 3 grams weekly."
Recent Business Highlights
Seribantumab
- Case study of a patient with pancreatic cancer treated with
seribantumab under a compassionate use program highlighted a
confirmed partial response and durable clinical benefit,
representing the first clinical data presented on the use of
seribantumab in a patient with a tumor harboring an NRG1
fusion. Treatment with seribantumab was included as part of a
case series presentation at the Australasian Gastro-Intestinal
Trials Group (AGITG) 2021 Annual Scientific Meeting in October. A
patient with treatment-refractory metastatic pancreatic cancer who
had their tumor genomically profiled through the Cancer Molecular
Screening and Therapeutics (MoST) program, was found to harbor an
NRG1 fusion, and subsequently received treatment with seribantumab
through a compassionate use program provided by Elevation Oncology.
As of the data cut-off for the presentation, treatment with
seribantumab resulted in durable clinical benefit for over 9
months, an approximately 90% reduction in the cancer biomarker
CA19-9, and an ongoing 3 month confirmed partial response per
RECIST criteria with a maximum tumor reduction of over 50%.
- Launched additional global clinical trial sites in
CRESTONE. The Company recently launched new clinical trial
sites in Canada and Australia. CRESTONE is now open and enrolling
patients at approximately 30 clinical trial sites across three
countries. Through the "just-in-time" clinical site model in
partnership with Caris Life Sciences, Tempus, and US Oncology,
there are over 400 available sites that can be activated within the
CRESTONE study.
Corporate
- Strengthened corporate leadership. During the third
quarter, the company announced Valerie
Malyvanh Jansen, MD, PhD, as the company's first Chief
Medical Officer. Dr. Jansen was promoted from her prior role as
Vice President, Clinical Development.
Upcoming Milestones
- Complete enrollment of the first 20 patients in Cohort 1 of the
CRESTONE study in mid-2022
- Present initial clinical data from approximately 10 patients
from Cohort 1 of the CRESTONE study treated with seribantumab at 3
grams weekly at a major medical meeting in mid-2022
Third Quarter 2021 Financial Results
As of September 30, 2021, the Company had cash and cash
equivalents totaling $155.2 million, which is expected to fund
current operations into the second quarter of 2023.
Research and development expenses for the third quarter 2021
were $9.3 million, compared to $2.6 million for the
third quarter 2020. The increase in R&D expense was primarily
related to an increase in manufacturing and clinical trial expenses
associated with the CRESTONE study.
General and administrative expenses for the third quarter 2021
were $3.0 million, compared to $0.5 million for the
third quarter 2020. The increase in G&A expense was primarily
related to personnel costs, professional services and consulting,
and other administrative costs.
Net loss for the third quarter 2021 was $12.3 million,
compared to $3.0 million for the third quarter 2020.
About Seribantumab and NRG1 Gene Fusions
Seribantumab is a fully human IgG2 monoclonal antibody that
binds to human epidermal growth factor receptor 3 (HER3). HER3 is
traditionally activated through binding of its primary ligand,
neuregulin-1 (NRG1). The NRG1 gene fusion is a rare genomic
alteration that combines NRG1 with another partner protein to
create chimeric NRG1 "fusion proteins". The NRG1 fusion protein is
often also able to activate the HER3 pathway, leading to
unregulated cell growth and proliferation. Importantly, NRG1 gene
fusions are predominantly mutually exclusive with other known
genomic driver mutations and are considered a unique oncogenic
driver event associated with tumor cell survival.
NRG1 fusions have been identified in a variety of solid tumors,
including lung, pancreatic, gallbladder, breast, ovarian,
colorectal, neuroendocrine, cholangiocarcinomas, and sarcomas. In
preclinical experiments, seribantumab prevented the activation of
HER3 signaling in cells that harbor an NRG1 gene fusion and
destabilized the entire ERBB family signaling pathway including the
activation of HER2, EGFR, and HER4. In addition to extensive
nonclinical characterization and testing, seribantumab has been
administered to over 800 patients across twelve Phase 1 and 2
studies, both as a monotherapy and in combination with various
anti-cancer therapies. Seribantumab is currently being evaluated in
the Phase 2 CRESTONE study for patients with solid tumors of any
origin that have an NRG1 fusion.
About the CRESTONE Study
Clinical Study of Response to Seribantumab in Tumors with
Neuregulin-1 (NRG1) Fusions. CRESTONE is a Phase 2 tumor-agnostic
"basket trial" of seribantumab in patients with solid tumors that
harbor an NRG1 fusion and have progressed after at least one prior
line of standard therapy. The primary objective of the study is to
describe the anti-tumor activity and safety of seribantumab as a
monotherapy specifically in patients whose solid tumor is uniquely
driven by an NRG1 gene fusion. CRESTONE offers a clinical trial
opportunity for patients with advanced solid tumors who have not
responded or are no longer responding to treatment. Patients are
encouraged to talk to their doctor about genomic testing of their
tumor. CRESTONE is open and enrolling today in the
United States, Australia, and Canada. For more information
visit www.NRG1fusion.com.
About Elevation Oncology, Inc.
Elevation Oncology is founded on the belief that every patient
living with cancer deserves to know what is driving the growth of
their disease and have access to therapeutics that can stop it. We
aim to make genomic tests actionable by selectively developing
drugs to inhibit the specific alterations that have been identified
as drivers of tumor growth. Together with our peers, we work
towards a future in which each tumor's unique genomic test result
can be matched with a purpose-built precision medicine to
enable an individualized treatment plan for each patient. Our lead
candidate, seribantumab, is intended to inhibit tumor growth driven
by NRG1 fusions and is currently being evaluated in the Phase 2
CRESTONE study for patients with solid tumors of any origin that
have an NRG1 gene fusion. Details on CRESTONE are available at
www.NRG1fusion.com. 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 seribantumab and the company's other
future product candidates, potential market opportunities for
seribantumab and the company's other future product
candidates, the ability of seribantumab and the company's
other future product candidates to treat their targeted
indications, and our expectations about our 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 the company believes that the expectations
reflected in such forward-looking statements are reasonable, the
company cannot guarantee future events, results, actions, levels of
activity, performance or achievements, and the timing and results
of biotechnology development and potential regulatory approval is
inherently uncertain. Forward-looking statements are subject to
risks and uncertainties that may cause the company's actual
activities or results to differ significantly from those expressed
in any forward-looking statement, including risks and uncertainties
related to the company'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
COVID-19 pandemic on the Company's business, the Company's ability
to fund development activities and achieve development goals, the
Company's ability to protect intellectual property, the Company's
ability to establish and maintain collaborations with third parties
and other risks and uncertainties described under the heading "Risk
Factors" in documents the company 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 the
company undertakes no obligation to revise or update any
forward-looking statements to reflect events or circumstances after
the date hereof.
Contact:
Argot Partners
212-600-1902
IR@ElevationOncology.com
Selected Financial
Information
|
(In thousands,
except share and per share data)
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended
September 30,
|
|
|
2021
|
|
2020
|
Statement of
Operations items:
|
|
|
|
|
|
|
Research and
development
|
|
$
|
9,298
|
|
$
|
2,550
|
General and
administrative
|
|
|
2,979
|
|
|
462
|
Total operating
expenses
|
|
|
12,277
|
|
|
3,012
|
Loss from
operations
|
|
|
(12,277)
|
|
|
(3,012)
|
Other
income
|
|
|
10
|
|
|
1
|
Net loss
|
|
$
|
(12,267)
|
|
$
|
(3,011)
|
Net loss per share,
basic and diluted
|
|
$
|
(0.53)
|
|
$
|
(3.80)
|
Weighted average
common shares outstanding, basic and diluted
|
|
|
23,114,715
|
|
|
792,790
|
|
|
|
Selected Financial
Information
|
(In thousands,
except share and per share data)
|
(unaudited)
|
|
|
|
|
|
|
|
September 30,
|
December 31,
|
Selected Balance
Sheet items:
|
2021
|
2020
|
Cash and cash
equivalents
|
$
155,198
|
$
79,400
|
|
|
|
Working
capital1
|
149,555
|
74,001
|
|
|
|
Total
assets
|
158,518
|
80,907
|
|
|
|
Total stockholders'
equity (deficit)
|
149,628
|
(23,081)
|
|
|
|
1 We
define working capital as current assets less current
liabilities.
|
|
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SOURCE Elevation Oncology