Verve Therapeutics Highlights Recent Company Progress and Reports Third Quarter 2023 Financial Results
07 Novembre 2023 - 12:30PM
Verve Therapeutics, Inc., a clinical-stage biotechnology company
pioneering a new approach to the care of cardiovascular disease
with single-course gene editing medicines, today reported recent
company progress and financial results for the third quarter of
2023.
“Verve was founded in 2018 with a vision to develop
single-course gene editing medicines for cardiovascular disease and
throughout this year, we have made tremendous strides towards
realizing that vision,” said Sekar Kathiresan, M.D., co-founder and
chief executive officer of Verve. “We continue to progress the
heart-1 Phase 1b trial of VERVE-101 in patients in the United
Kingdom and New Zealand, and we are looking forward to presenting
interim data from this trial at the upcoming AHA meeting. We have
obtained clearance of our first IND application from the FDA, which
now enables us to add U.S. sites to the heart-1 trial and begins
the regulatory path in the U.S. for VERVE-101. Beyond VERVE-101, we
remain focused on advancing our pipeline and are on-track to
initiate Phase 1 clinical trials for VERVE-102 in the first half of
2024 and VERVE-201 in the second half of 2024. Finally, we are
thrilled to gain Lilly as a collaborator for our PCSK9 and ANGPTL3
programs. Lilly brings development expertise as well as a track
record of successful commercialization of cardiometabolic
medicines. We believe all of this progress in 2023 moves us closer
to being able to deliver a new class of medicines to patients
living with atherosclerotic cardiovascular disease (ASCVD).”
VERVE-101 heart-1 Phase 1b Interim Data to be Presented
at the American Heart Association’s Scientific Sessions
2023
- VERVE-101, an in vivo base editing medicine delivered as a
one-time intravenous infusion, is designed to inactivate the PCSK9
gene in liver cells, turning off liver production of PCSK9 protein
and thereby durably reducing low-density lipoprotein cholesterol
(LDL-C). VERVE-101 is being developed initially for the treatment
of patients living with HeFH.
- VERVE-101 is being evaluated in the Phase 1b heart-1 clinical
trial with trial endpoints of safety and tolerability as well as
blood PCSK9 protein and LDL-C levels. In September, the company
announced that it will present interim data from the heart-1 trial
in a late-breaking science presentation at the AHA Scientific
Sessions 2023 on Sunday, November 12 from 3:30 – 3:40 p.m. ET. At
AHA, Verve expects to report initial safety, tolerability and
pharmacodynamic data, as well as changes in blood PCSK9 protein and
LDL-C levels, from patients across four single-ascending dose
cohorts.
- Verve is hosting an investor event on Sunday, November 12 from
6:30 – 8:30 p.m. ET in Philadelphia. The event will be accessible
virtually and in-person. The webcast will be available under the
“Events” section of the company’s website at
https://ir.vervetx.com/events. Following the live event, an
archived replay of the webcast will be made available on the
company website.
- In October, Verve announced that the U.S. FDA cleared its
Investigational New Drug Application for VERVE-101 in patients
living with HeFH. Verve plans to activate U.S. sites to supplement
the already active sites in the United Kingdom and New
Zealand.
VERVE-102 On-Track for Clinical Trial Initiation in
First Half of 2024
- VERVE-102 is an in vivo base editing medicine that aims to
inactivate the PCSK9 gene in a similar way to VERVE-101. VERVE-101
and VERVE-102 share an identical guide RNA targeting PCSK9 as well
as similar messenger RNA expressing an adenine base editor;
however, VERVE-102 is delivered using the company’s proprietary
GalNAc-LNP delivery technology. Preclinical studies with VERVE-102
in mice and non-human primates demonstrated effective in vivo liver
gene editing and significant reduction of blood PCSK9 protein.
- Preclinical development to support a regulatory submission for
VERVE-102 began in early 2022, and, following regulatory clearance,
Verve expects to initiate a Phase 1b clinical trial with VERVE-102
for patients with HeFH in the first half of 2024.
VERVE-201 On-Track for Clinical Trial Initiation in
Second Half of 2024
- VERVE-201, an in vivo base editing medicine delivered as a
one-time intravenous infusion, is designed to inactivate the
ANGPTL3 gene in liver cells, turning off liver production of blood
ANGPTL3 and thereby durably reducing blood LDL-C and
triglyceride-rich lipoproteins. VERVE-201 is being developed
initially for the treatment of patients living with homozygous
familial hypercholesterolemia (HoFH), a rare and often fatal
genetic subtype of premature ASCVD characterized by extremely high
blood LDL-C. VERVE-201 aims to reduce the heavy treatment burden
associated with available therapies for HoFH including the
requirement for multiple oral, injectable, and intravenous
infusions, often administered over decades.
- Preclinical studies to support a regulatory submission for
clinical development of VERVE-201 are ongoing, and, following
regulatory clearance, Verve expects to initiate a Phase 1b clinical
trial with VERVE-201 in the second half of 2024.
Corporate Update
- In October 2023, Verve announced the expansion of its
relationship with Lilly which has acquired from Beam Therapeutics
certain product rights to Verve’s cardiovascular in
vivo gene editing programs
targeting PCSK9 and ANGPTL3, as well as a third
undisclosed cardiovascular disease target. In June 2023, Verve
and Lilly entered into an exclusive research collaboration focused
on advancing Verve’s preclinical stage in vivo gene
editing program targeting lipoprotein(a) (Lp(a)).
- In September 2023, Verve announced
the appointment of Frederick “Fred” T. Fiedorek, M.D., as chief
medical officer.
- In addition, Jason Politi, B.S.,
M.B.A., who has served as Verve’s senior vice president, technical
operations since 2021, has been promoted to the role of chief
technical operations officer.
Other Upcoming Investor EventsVerve plans to
participate in fireside chats during the following upcoming
investor events:
- Stifel Healthcare Conference, November 14, New York City
- Jefferies London Healthcare Conference, November 16, London,
UK
Third Quarter 2023 Financial Results
- Cash Position: Verve ended the third quarter
of 2023 with $485.2 million in cash, cash equivalents, and
marketable securities. Verve expects its existing cash, cash
equivalents, and marketable securities to be sufficient to fund its
operations into 2026.
- Collaboration Revenue: Collaboration revenue
was $3.1 million for the third quarter of 2023, which was related
to research services performed under the collaboration agreement
with Vertex Pharmaceuticals Incorporated (Vertex) and the Lp(a)
collaboration with Lilly. Collaboration revenue in the third
quarter of 2022 was $0.9 million which was related to research
services performed under the collaboration agreement with
Vertex.
- Research & Development (R&D) Expenses:
R&D expenses were $43.8 million for the third quarter of 2023,
compared to $35.2 million for the third quarter of 2022.
- General & Administrative (G&A)
Expenses: G&A expenses were $11.7 million for the
third quarter of 2023, compared to $9.6 million for the third
quarter of 2022.
- Net Loss: Net loss was $45.8 million, or $0.72
basic and diluted net loss per share, for the third quarter of
2023, compared to $45.2 million, or $0.79 basic and diluted net
loss per share, for the third quarter of 2022.
About Verve Therapeutics Verve Therapeutics,
Inc. (Nasdaq: VERV) is a clinical-stage genetic medicines company
pioneering a new approach to the care of cardiovascular disease,
potentially transforming treatment from chronic management to
single-course gene editing medicines. The company’s initial three
programs – VERVE-101, VERVE-102, and VERVE-201 – target genes that
have been extensively validated as targets for lowering low-density
lipoprotein cholesterol (LDL-C), a root cause of cardiovascular
disease, in order to durably reduce blood LDL-C levels. VERVE-101
and VERVE-102 are designed to permanently turn off the PCSK9 gene
in the liver and are being developed initially for heterozygous
familial hypercholesterolemia (HeFH) and ultimately to treat
atherosclerotic cardiovascular disease (ASCVD) patients not at goal
on oral therapy. VERVE-201 is designed to permanently turn off the
ANGPTL3 gene in the liver and is initially being developed for
homozygous familial hypercholesterolemia (HoFH) and ultimately to
treat patients with refractory hypercholesterolemia. For more
information, please visit www.VerveTx.com.
Cautionary Note Regarding Forward Looking
Statements This press release contains “forward-looking
statements” within the meaning of the Private Securities Litigation
Reform Act of 1995 that involve substantial risks and
uncertainties, including statements regarding the company’s ability
to enroll patients in its ongoing heart-1 trial and activate
clinical trial sites in the United States; the timing and
availability of clinical data from its heart-1 trial; the expected
timing of initiating clinical trials of VERVE-102 and VERVE-201;
its research and development plans; the potential advantages and
therapeutic potential of the company’s programs, including
VERVE-101, VERVE-102, and VERVE-201; and the period over which the
company believes that its existing cash, cash equivalents and
marketable securities will be sufficient to fund its operating
expenses. All statements, other than statements of historical
facts, contained in this press release, including statements
regarding the company’s strategy, future operations, future
financial position, prospects, plans and objectives of management,
are forward-looking statements. The words “anticipate,” “believe,”
“continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,”
“potential,” “predict,” “project,” “should,” “target,” “will,”
“would” and similar expressions are intended to identify
forward-looking statements, although not all forward-looking
statements contain these identifying words. Any forward-looking
statements are based on management’s current expectations of future
events and are subject to a number of risks and uncertainties that
could cause actual results to differ materially and adversely from
those set forth in, or implied by, such forward-looking statements.
These risks and uncertainties include, but are not limited to,
risks associated with the company’s limited operating history; the
company’s ability to timely submit and receive approvals of
regulatory applications for its product candidates; advance its
product candidates in clinical trials; initiate, enroll and
complete its ongoing and future clinical trials on the timeline
expected or at all; correctly estimate the potential patient
population and/or market for the company’s product candidates;
replicate in clinical trials positive results found in preclinical
studies and/or earlier-stage clinical trials of VERVE-101,
VERVE-102, and VERVE-201; advance the development of its product
candidates under the timelines it anticipates in current and future
clinical trials; obtain, maintain or protect intellectual property
rights related to its product candidates; manage expenses; and
raise the substantial additional capital needed to achieve its
business objectives. For a discussion of other risks and
uncertainties, and other important factors, any of which could
cause the company’s actual results to differ from those contained
in the forward-looking statements, see the “Risk Factors” section,
as well as discussions of potential risks, uncertainties and other
important factors, in the company’s most recent filings with the
Securities and Exchange Commission and in other filings that the
company makes with the Securities and Exchange Commission in the
future. In addition, the forward-looking statements included in
this press release represent the company’s views as of the date
hereof and should not be relied upon as representing the company’s
views as of any date subsequent to the date hereof. The company
anticipates that subsequent events and developments will cause the
company’s views to change. However, while the company may elect to
update these forward-looking statements at some point in the
future, the company specifically disclaims any obligation to do
so.
Investor ContactJen RobinsonVerve Therapeutics,
Inc.jrobinson@vervetx.com
Media ContactAshlea Kosikowski
1ABashlea@1abmedia.com
|
Verve Therapeutics, Inc.Selected Condensed
Financial Information(in thousands, except share
and per share amounts)(unaudited) |
|
|
|
Three months endedSeptember 30, |
|
|
Nine months endedSeptember 30, |
|
Condensed consolidated
statements of operations |
|
|
2023 |
|
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Collaboration revenue |
|
$ |
3,117 |
|
|
$ |
929 |
|
|
$ |
6,614 |
|
|
$ |
929 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
43,765 |
|
|
|
35,197 |
|
|
|
138,135 |
|
|
|
92,811 |
|
General and administrative |
|
|
11,686 |
|
|
|
9,592 |
|
|
|
37,655 |
|
|
|
26,095 |
|
Total operating expenses |
|
|
55,451 |
|
|
|
44,789 |
|
|
|
175,790 |
|
|
|
118,906 |
|
Loss from operations |
|
|
(52,334 |
) |
|
|
(43,860 |
) |
|
|
(169,176 |
) |
|
|
(117,977 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Change in fair value of success payment liability |
|
|
802 |
|
|
|
(3,306 |
) |
|
|
878 |
|
|
|
(691 |
) |
Interest and other income, net |
|
|
5,841 |
|
|
|
1,976 |
|
|
|
16,825 |
|
|
|
2,366 |
|
Total other income (expense), net |
|
|
6,643 |
|
|
|
(1,330 |
) |
|
|
17,703 |
|
|
|
1,675 |
|
Loss before provision for
income taxes |
|
|
(45,691 |
) |
|
|
(45,190 |
) |
|
|
(151,473 |
) |
|
|
(116,302 |
) |
Provision for income
taxes |
|
|
(67 |
) |
|
|
- |
|
|
|
(243 |
) |
|
|
- |
|
Net loss |
|
$ |
(45,758 |
) |
|
$ |
(45,190 |
) |
|
$ |
(151,716 |
) |
|
$ |
(116,302 |
) |
Net loss per common share,
basic and diluted |
|
$ |
(0.72 |
) |
|
$ |
(0.79 |
) |
|
$ |
(2.43 |
) |
|
$ |
(2.26 |
) |
Weighted-average common shares
used in net loss per share, basic and diluted |
|
|
63,211,849 |
|
|
|
57,207,125 |
|
|
|
62,322,965 |
|
|
|
51,516,037 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Condensed consolidated balance sheet data |
|
September 30,2023 |
|
|
December 31,2022 |
|
Cash, cash equivalents and marketable securities |
|
$ |
485,226 |
|
|
$ |
554,808 |
|
Total assets |
|
$ |
612,407 |
|
|
$ |
679,223 |
|
Total liabilities |
|
$ |
152,038 |
|
|
$ |
128,291 |
|
Total stockholders' equity |
|
$ |
460,369 |
|
|
$ |
550,932 |
|
Grafico Azioni Verve Therapeutics (NASDAQ:VERV)
Storico
Da Mag 2024 a Giu 2024
Grafico Azioni Verve Therapeutics (NASDAQ:VERV)
Storico
Da Giu 2023 a Giu 2024