Verve Therapeutics, a clinical-stage company developing a new class
of genetic medicines for cardiovascular disease, today reported
pipeline updates and financial results for the quarter ended June
30, 2024.
“The second quarter has been a period of continued execution for
Verve, underscored by our commitment to protecting patients from
cardiovascular disease through single-course gene editing
medicines,” said Sekar Kathiresan, M.D., co-founder and chief
executive officer of Verve Therapeutics. “Our Heart-2 Phase 1b
clinical trial of VERVE-102 continues to progress as we focus on
enrolling patients and expanding the trial’s geographic footprint,
highlighted by our recent regulatory clearance in Australia. We
look forward to providing initial data from the Heart-2 clinical
trial in the first half of 2025. In addition, we are on track to
initiate the Phase 1b clinical trial for our ANGPTL3 product
candidate, VERVE-201, in the second half of this year, and we
continue to advance our early-stage programs, including one
targeting the LPA gene.”
Dr. Kathiresan added, “The clinical benefit from controlling
blood cholesterol depends on two factors: the amount of reduction
and, maybe even more importantly, how long that reduction is
sustained. Despite available therapies, sustained cholesterol
lowering is happening in too few patients. Verve aims to be at the
forefront of addressing this unmet need through a pipeline of
product candidates designed to provide lifelong cholesterol
lowering after a single treatment. We are well positioned to
execute on this vision with a strong cash position and runway
expected into late 2026 and are resolute in our approach to
developing a new standard of care for the millions of patients with
heart disease.”
PCSK9 ProgramEnrollment Ongoing in Heart-2
Clinical Trial Evaluating VERVE-102
- VERVE-102 is a novel, investigational gene editing medicine
designed to be a single course treatment that permanently turns off
the PCSK9 gene in the liver to durably reduce
disease-driving low-density lipoprotein cholesterol (LDL-C).
VERVE-102 consists of messenger RNA expressing an adenine base
editor and an optimized guide RNA targeting
the PCSK9 gene, identical to VERVE-101, the company’s
initial PCSK9 product candidate that showed proof-of concept for
this mechanism. However, compared to VERVE-101, VERVE-102 uses a
different lipid nanoparticle (LNP) delivery system, which includes
a different ionizable lipid and Verve’s proprietary GalNAc
liver-targeting ligand, designed to allow the LNP to access liver
cells using either the low-density lipoprotein receptor (LDLR) or
the asialoglycoprotein receptor (ASGPR).
- VERVE-102 is being evaluated in the Heart-2 clinical trial, an
open-label Phase 1b clinical trial, in two patient populations –
adult patients living with heterozygous familial
hypercholesterolemia (HeFH) and adult patients living with
premature coronary artery disease (CAD). Each of these patient
populations requires deep, long-term LDL-C lowering.
- Verve recently received clearance of its Clinical Trial
Application (CTA) for VERVE-102 in Australia. Following earlier CTA
clearances in the U.K. and Canada, the company is continuing to
open clinical trial sites and enrollment is ongoing in those
regions.
- Verve expects to provide initial data from the Heart-2 clinical
trial and an update on the PCSK9 program in the first half of 2025
and plans to initiate the Phase 2 clinical trial for the PCSK9
program in the second half of 2025.
Analysis of Heart-1 Clinical Trial of VERVE-101
- Enrollment remains paused in the Phase 1b Heart-1 clinical
trial as Verve completes its investigation of the observed
laboratory abnormalities and further explores potential mitigation
measures. Preliminary data from Verve’s investigations, including
data from animal models, supports Verve’s initial understanding
that laboratory abnormalities observed in the Heart-1 trial are
attributable to the LNP used in VERVE-101.
- As Verve continues to work with regulatory authorities to
define a potential path forward, the VERVE-101 Investigational New
Drug Application (IND) in the U.S. and CTAs in the U.K. and New
Zealand remain active.
ANGPTL3 ProgramVERVE-201 on Track for Clinical
Trial Initiation in Second Half of 2024
- VERVE-201 is a novel, investigational gene editing medicine
designed to be a single course treatment that permanently turns off
the ANGPTL3 gene in the liver to reduce disease-driving LDL-C as
well as remnant cholesterol and utilizes Verve’s proprietary
GalNAc-LNP delivery technology. VERVE-201 is being developed for
the treatment of atherosclerotic cardiovascular disease (ASCVD)
patients with refractory hypercholesterolemia, who have high LDL-C
despite treatment with maximally tolerated standard of care
therapies, as well as patients living with homozygous familial
hypercholesterolemia (HoFH), a rare and often fatal inherited
subtype of premature ASCVD characterized by extremely high blood
LDL-C. The aim of this medicine is to reduce the heavy treatment
burden associated with available therapies, including the
requirement for multiple oral, injectable, and intravenous
infusions, often administered over decades.
- Verve has completed preclinical studies to support regulatory
submissions for clinical development and expects to initiate the
VERVE-201 Phase 1b clinical trial in the second half of 2024,
subject to regulatory clearances.
Upcoming Investor EventsVerve plans to
participate in fireside chats/presentations during the following
upcoming investor events:
- Canaccord Genuity 44th Annual Growth Conference, August 13 at
10:00 AM ET, Boston, MA
- Cantor Fitzgerald Global Healthcare Conference, September 17 at
9:45 AM ET, New York, NY
Upcoming Medical Meeting Presentations
- CSH 2024 Genome Engineering: CRISPR Frontiers Meeting, August
27-31, Cold Spring Harbor, NY
- European Society of Gene & Cell Therapy (ESGCT), October
22-25, Rome, Italy
- American Society of Nephrology (ASN) Kidney Week 2024, October
25, San Diego, CA
Second Quarter 2024 Financial Results
Cash Position: Verve ended the second quarter
of 2024 with $575.9 million in cash, cash equivalents, and
marketable securities. Verve continues to expect its capital
position to be sufficient to fund its operations into late
2026.
Collaboration Revenue: Collaboration revenue
was $6.7 million for the second quarter of 2024, compared to $2.1
million for the second quarter of 2023. The increase was primarily
due to an increase in research services performed under the
company’s collaboration agreements.
Research & Development (R&D) Expenses:
R&D expenses were $51.0 million for the second quarter of 2024,
compared to $47.3 million for the second quarter of 2023.
Stock-based compensation expense included in R&D expenses was
$6.5 million and $4.8 million for the second quarter of 2024 and
2023, respectively.
General & Administrative (G&A)
Expenses: G&A expenses were $14.5 million for the
second quarter of 2024, compared to $13.4 million for the second
quarter of 2023. Stock-based compensation expense included in
G&A expenses was $5.2 million and $4.2 million for the second
quarter of 2024 and 2023, respectively.
Net Loss: Net loss was $49.8 million, or $0.59
basic and diluted net loss per share, for the second quarter of
2024, compared to $54.0 million, or $0.87 basic and diluted net
loss per share, for the second quarter of 2023.
About Verve Therapeutics Verve
Therapeutics, Inc. (Nasdaq: VERV) is a clinical-stage company
developing a new class of genetic medicines for cardiovascular
disease with the potential to transform treatment from chronic
management to single-course gene editing medicines. The company’s
lead 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
atherosclerotic cardiovascular disease (ASCVD). 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
patients with established ASCVD who continue to be impacted by high
LDL-C levels. VERVE-201 is designed to permanently turn off the
ANGPTL3 gene in the liver and is initially being developed for
refractory hypercholesterolemia, where patients still have high
LDL-C despite treatment with maximally tolerated standard of care
therapies, and homozygous familial hypercholesterolemia (HoFH). For
more information, please visit www.VerveTx.com.
Cautionary Note Regarding Forward Looking
StatementsThis 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 ongoing
Heart-2 clinical trial; the timing and availability of data for the
Heart-2 trial and PCSK9 program; expectations for the company’s
Heart-1 clinical trial, including the company’s assessment of the
laboratory abnormalities observed in the trial and the company’s
interactions with regulatory authorities regarding VERVE-101; the
receipt of regulatory clearances and expected timing of initiating
the clinical trial of VERVE-201; its research and development
plans; the potential advantages and therapeutic potential of the
company’s programs; 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
Kosikowski1ABashlea@1abmedia.com
Verve Therapeutics, Inc.Selected Condensed
Consolidated Financial Information(in thousands,
except share and per share
amounts)(unaudited) |
|
|
Three months ended June 30, |
|
Six months ended June 30, |
|
Condensed consolidated statements of
operations |
|
2024 |
|
|
|
2023 |
|
2024 |
|
2023 |
|
Collaboration revenue |
$ |
6,692 |
|
|
$ |
2,093 |
|
|
$ |
12,387 |
|
|
$ |
3,497 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
50,984 |
|
|
|
47,260 |
|
|
|
99,361 |
|
|
|
94,370 |
|
General and administrative |
|
14,547 |
|
|
|
13,416 |
|
|
|
28,709 |
|
|
|
25,969 |
|
Total operating expenses |
|
65,531 |
|
|
|
60,676 |
|
|
|
128,070 |
|
|
|
120,339 |
|
Loss
from operations |
|
(58,839 |
) |
|
|
(58,583 |
) |
|
|
(115,683 |
) |
|
|
(116,842 |
) |
Other
income (expense): |
|
|
|
|
|
|
|
|
Change in fair value of success payment liability |
|
1,671 |
|
|
|
(662 |
) |
|
|
1,749 |
|
|
|
76 |
|
Interest and other income, net |
|
7,429 |
|
|
|
5,438 |
|
|
|
15,565 |
|
|
|
10,984 |
|
Total other income, net |
|
9,100 |
|
|
|
4,776 |
|
|
|
17,314 |
|
|
|
11,060 |
|
Loss
before provision for income taxes |
|
(49,739 |
) |
|
|
(53,807 |
) |
|
|
(98,369 |
) |
|
|
(105,782 |
) |
Provision for income taxes |
|
(66 |
) |
|
|
(176 |
) |
|
|
(172 |
) |
|
|
(176 |
) |
Net
loss |
$ |
(49,805 |
) |
|
$ |
(53,983 |
) |
|
$ |
(98,541 |
) |
|
$ |
(105,958 |
) |
Net loss
per common share, basic and diluted |
$ |
(0.59 |
) |
|
$ |
(0.87 |
) |
|
$ |
(1.18 |
) |
|
$ |
(1.71 |
) |
Weighted-average common shares used in net loss per share, basic
and diluted |
|
84,226,523 |
|
|
|
61,953,992 |
|
|
|
83,679,742 |
|
|
|
61,871,158 |
|
Condensed consolidated balance sheet data |
June 30,2024 |
|
December 31,2023 |
|
Cash, cash equivalents and marketable securities |
$ |
575,948 |
|
|
$ |
623,950 |
|
Total assets |
$ |
700,910 |
|
|
$ |
752,688 |
|
Total liabilities |
$ |
154,816 |
|
|
$ |
153,186 |
|
Total stockholders' equity |
$ |
546,094 |
|
|
$ |
599,502 |
|
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