Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage
immunology company dedicated to enabling normal lives for people
with autoimmune diseases, today reported development updates and
financial results for its fiscal second quarter ended September 30,
2024.
Immunovant continues to focus on moving rapidly to unlock the
full potential of its lead asset, IMVT-1402, for the benefit of
people with underserved autoantibody-driven diseases. With five IND
applications now cleared, the company remains on course to initiate
four to five potentially registrational clinical development
programs by March 31, 2025. These INDs are expected to support
evaluation of IMVT-1402 in a variety of indications and therapeutic
areas. As previously announced, Immunovant anticipates initiating
clinical trials evaluating IMVT-1402 in a total of ten indications
by March 31, 2026.
“Since announcing the Phase 1 data for IMVT-1402 a year ago, we
have made tremendous progress in advancing IMVT-1402 towards
multiple potentially registrational study initiations. We’re ahead
of our goal to activate three INDs by calendar year end and we are
very excited about all five cleared INDs – both those that have
been announced and those that have not yet been announced. In terms
of announced indications, we believe our first-in-class program
with IMVT-1402 in GD has the potential to transform the treatment
of GD patients who respond poorly to ATDs,” said Pete Salzmann,
M.D., chief executive officer of Immunovant.
“We are also excited to announce expansion of our IMVT-1402
development program into Rheumatology. Our first program in
Rheumatology will be a potentially registrational study in patients
with D2T RA where we believe that deeper IgG reduction has the
potential to deliver better clinical outcomes in an important
subset of patients with elevated RA-specific autoantibodies (ACPA).
People living with D2T RA have already exhausted multiple
therapeutic options yet continue to suffer from active disease,
persistent disability and pain,” Salzmann continued. “We believe
IMVT-1402 can deliver meaningful clinical benefit in ACPA-positive
(ACPA+) D2T RA patients, with a potentially best-in-class profile
driven by deeper IgG reduction.”
FcRn inhibition represents an attractive mechanism as a
potential treatment for the approximately 70,000 US patients with
D2T, ACPA+ RA. Recently disclosed in-class data demonstrated that
both higher baseline ACPA levels and deeper ACPA reduction
correlated with better clinical improvement in ACPA+ RA patients
treated with an FcRn inhibitor. Having received FDA clearance of
the IND for IMVT-1402 in RA, Immunovant plans to initiate a
potentially registrational trial in ACPA+ D2T RA by March 31, 2025.
The trial builds on in-class learning in terms of its target
population (enriched for above-normal ACPA levels) and trial design
(open-label lead-in followed by randomized withdrawal). The trial
will leverage IMVT-1402’s higher dose (600 mg) during the
open-label induction phase of the clinical trial to maximize
reduction in ACPA levels.
Recent Highlights and Upcoming Milestones
Endocrinology Program
In September 2024, Immunovant provided a GD program update
consisting of new epidemiologic data characterizing unmet need in
GD patients who are relapsed, uncontrolled or intolerant of ATDs,
additional results from the batoclimab GD study, and an overview of
the IMVT-1402 development program in GD. In November
2024, additional data on the efficacy and safety of batoclimab in
Graves’ thyroidal and extrathyroidal disease were presented in an
oral presentation at the American Thyroid Association (ATA) 2024
Annual Meeting. These data showed that a 60% response rate (defined
as T3 and T4 falling below the upper limit of normal (ULN) without
increasing the ATD dose) was achieved by Week 2, demonstrating the
rapidity of response to batoclimab 680mg dosed weekly. Meaningful
improvements in proptosis and lid aperture were also observed at
both Week 12 and Week 24. Pronounced improvements in multiple
Thyroid-Related Patient-Reported Outcomes (ThyPRO-39) measurement
scales were also observed, with ATD-Free Responders (defined as T3
and T4 falling below the ULN and ceasing all ATD medications)
reporting greater improvements than other participants.
The batoclimab data in Graves’ disease support the potential for
deep IgG reduction to modify the underlying pathophysiology of the
disease, which could enable a transformation of the treatment of
Graves’ disease for patients not well controlled on ATDs.
Immunovant remains on track to initiate the first potentially
registrational trial of IMVT-1402 in GD by calendar year end.
Competition for clinical trial participants with acute, active
TED has increased over the course of the company’s Phase 3 program
to evaluate batoclimab for the treatment of thyroid eye disease
(TED). As a result, top-line results are now expected to be
available in the second half of calendar year 2025, along with a
decision on whether to advance batoclimab to registration in TED.
Data from this trial will be leveraged to inform the overall
program in GD for the Company’s lead asset, IMVT-1402.
Neurology Program
As previously reported, Immunovant completed enrollment of the
batoclimab pivotal trial in MG, with top-line results expected to
be reported by March 31, 2025. Results from this trial are expected
to inform a decision regarding next steps for batoclimab in MG and
the design of the MG program for IMVT-1402, which Immunovant
expects to initiate by March 31, 2025.
Enrollment of study participants has completed in the Phase 2b
trial evaluating batoclimab in chronic inflammatory demyelinating
polyneuropathy (CIDP) for those patients to be included in the
period 1 data readout expected by March 31, 2025. A decision
to enroll additional patients in the batoclimab CIDP study will be
made following the readout of period 1 data. Those results, as well
as observations drawn from public disclosures of other studies in
CIDP, will be used to inform the trial design for a potentially
registrational program for IMVT-1402 in CIDP.
Corporate Update
Immunovant also announced today that it appointed Melanie Gloria
as Chief Operating Officer, effective November 18, 2024. Ms. Gloria
brings over 20 years of experience in the biotechnology industry,
including leadership roles at Acelyrin, Horizon Therapeutics and
AbbVie. At AbbVie and Horizon she led teams to achieve global
approvals of HUMIRA®, Viekera Pak®, Mavyret®, Skyrizi®, Rinvoq®,
TEPEZZA®, and ORILISSA®. “I am thrilled to welcome Melanie to
Immunovant where her success in driving late-stage drug development
will be incredibly valuable,” said Salzmann. “Melanie’s proven drug
development capabilities are a great fit for Immunovant’s
portfolio.”
Webcast Details
Immunovant will host a webcast at 8:00 a.m. ET today to discuss
these updates. Please click register
here to register for the event.
The live webcast will also be available under the News & Events
section of Immunovant’s website. A replay of the event and
presentation will be available immediately following the event.
Financial Highlights for Fiscal Second Quarter Ended
September 30, 2024:
Cash Position: As of September 30, 2024,
Immunovant’s cash and cash equivalents totaled approximately $472.9
million.
R&D Expenses: Research and development
expenses were $97.3 million for the three months ended September
30, 2024, compared to $48.0 million for the three months ended
September 30, 2023. The increase was primarily due to activities in
preparation for potential future clinical trials of IMVT-1402,
including contract manufacturing costs for drug substance, higher
overall clinical trial costs related to our batoclimab pivotal
clinical trials, and elevated personnel-related expenses. The
increase was partially offset by lower overall costs related to our
IMVT-1402 Phase 1 trial and nonclinical studies.
G&A Expenses: General and administrative
expenses were $18.5 million for the three months ended September
30, 2024, compared to $13.8 million for the three months ended
September 30, 2023. The increase was primarily due to higher
personnel-related expenses, legal and other professional fees, and
information technology costs.
Net Loss: Net loss was $109.1 million ($0.74
per common share) for the three months ended September 30, 2024,
compared to $58.7 million ($0.45 per common share) for the three
months ended September 30, 2023. Net loss for the three months
ended September 30, 2024 and September 30, 2023 included $12.7
million and $10.5 million, respectively, related to non-cash
stock-based compensation expense.
Common Stock: As of September 30, 2024, there
were 146,565,049 shares of common stock issued and outstanding.
Financial Highlights for Fiscal Six Months Ended
September 30, 2024:
R&D Expenses: Research and development
expenses were $172.7 million for the six months ended September 30,
2024, compared to $98.5 million for the six months ended September
30, 2023. The increase was primarily due to activities in
preparation for potential future clinical trials of IMVT-1402,
including contract manufacturing costs for drug substance, higher
overall clinical trial costs related to our batoclimab pivotal
clinical trials, and elevated personnel-related expenses. The
increase was partially offset by lower overall costs related to our
IMVT-1402 Phase 1 trial and nonclinical studies.
IPR&D Expenses: There were no acquired
in-process research and development expenses for the six months
ended September 30, 2024. During the six months ended September 30,
2023, acquired in-process research and development expenses were
$12.5 million related to the achievement of development and
regulatory milestones for batoclimab under the terms of the HanAll
in-license agreement.
G&A Expenses: General and administrative
expenses were $37.3 million for the six months ended September 30,
2024, compared to $29.2 million for the six months ended September
30, 2023. The increase was primarily due to higher
personnel-related expenses, legal and other professional fees, and
information technology costs.
Net Loss: Net loss was $196.3 million ($1.34
per common share) for the six months ended September 30, 2024,
compared to $132.6 million ($1.01 per common share) for the six
months ended September 30, 2023. Net loss for the six months ended
September 30, 2024 and September 30, 2023 included $26.1 million
and $21.2 million, respectively, related to non-cash stock-based
compensation expense.
About Immunovant, Inc.
Immunovant, Inc. is a clinical-stage immunology company
dedicated to enabling normal lives for people with autoimmune
diseases. As a trailblazer in anti-FcRn technology, the Company is
developing innovative, targeted therapies to meet the complex and
variable needs of people with autoimmune diseases. For additional
information on the Company, please visit immunovant.com.
Forward-Looking Statements
This press release contains forward-looking statements for the
purposes of the safe harbor provisions under The Private Securities
Litigation Reform Act of 1995 and other federal securities laws.
The use of words such as “can,” “may,” “might,” “will,” “would,”
“should,” “expect,” “believe,” “estimate,” “design,” “plan,”
“anticipate,” “intend,” and other similar expressions are intended
to identify forward-looking statements. Such forward looking
statements include statements regarding Immunovant’s expectations
regarding the timing, design, and results of clinical trials of
IMVT-1402 and batoclimab, including the number and timing of (a)
FDA clearance with respect to IND applications, (b) potential
registrational programs and clinical trials of IMVT-1402,
(c) expected data readouts from batoclimab trials in MG and
CIDP, and (d) estimates of the target populations for
IMVT-1402, including in RA; Immunovant’s plan to develop IMVT-1402
and batoclimab across a broad range of indications; and potential
benefits of IMVT-1402’s unique product attributes and potential
best-in-class profile. All forward-looking statements are based on
estimates and assumptions by Immunovant’s management that, although
Immunovant believes to be reasonable, are inherently uncertain. All
forward-looking statements are subject to risks and uncertainties
that may cause actual results to differ materially from those that
Immunovant expected. Such risks and uncertainties include, among
others: Immunovant may not be able to protect or enforce its
intellectual property rights; initial results or other preliminary
analyses or results of early clinical trials may not be predictive
of final trial results or of the results of later clinical trials;
the timing and availability of data from clinical trials; the
timing of discussions with regulatory agencies, as well as
regulatory submissions and potential approvals; the continued
development of Immunovant’s product candidates, including the
number and timing of the commencement of additional clinical
trials; Immunovant’s scientific approach, clinical trial design,
indication selection, and general development progress; future
clinical trials may not confirm any safety, potency, or other
product characteristics described or assumed in this press release;
any product candidate that Immunovant develops may not progress
through clinical development or receive required regulatory
approvals within expected timelines or at all; Immunovant’s product
candidates may not be beneficial to patients, or even if approved
by regulatory authorities, successfully commercialized; the
potential impact of macroeconomic and geopolitical factors on
Immunovant’s business operations and supply chain, including its
clinical development plans and timelines; Immunovant’s business is
heavily dependent on the successful development, regulatory
approval, and commercialization of IMVT-1402 and/or batoclimab;
Immunovant is at various stages of clinical development for
IMVT-1402 and batoclimab; and Immunovant will require additional
capital to fund its operations and advance IMVT-1402 and batoclimab
through clinical development. These and other risks and
uncertainties are more fully described in Immunovant’s periodic and
other reports filed with the Securities and Exchange Commission
(SEC), including in the section titled “Risk Factors” in
Immunovant’s Form 10-Q to be filed with the SEC on November 7,
2024, and Immunovant’s subsequent filings with the SEC. Any
forward-looking statement speaks only as of the date on which it
was made. Immunovant undertakes no obligation to publicly update or
revise any forward-looking statement, whether as a result of new
information, future events or otherwise.
|
IMMUNOVANT, INC.Consolidated Statements of
Operations(Unaudited, in thousands, except share and per
share data) |
|
|
Three Months EndedSeptember
30, |
|
Six Months EndedSeptember
30, |
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
Operating
expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
97,272 |
|
|
$ |
47,959 |
|
|
$ |
172,745 |
|
|
$ |
98,534 |
|
Acquired in-process research and development |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
12,500 |
|
General and administrative |
|
18,471 |
|
|
|
13,841 |
|
|
|
37,279 |
|
|
|
29,243 |
|
Total operating expenses |
|
115,743 |
|
|
|
61,800 |
|
|
|
210,024 |
|
|
|
140,277 |
|
Interest income |
|
(6,073 |
) |
|
|
(3,572 |
) |
|
|
(13,254 |
) |
|
|
(7,637 |
) |
Other income, net |
|
(629 |
) |
|
|
(20 |
) |
|
|
(657 |
) |
|
|
(484 |
) |
Loss before provision for
income taxes |
|
(109,041 |
) |
|
|
(58,208 |
) |
|
|
(196,113 |
) |
|
|
(132,156 |
) |
Provision for income
taxes |
|
78 |
|
|
|
454 |
|
|
|
156 |
|
|
|
443 |
|
Net loss |
$ |
(109,119 |
) |
|
$ |
(58,662 |
) |
|
$ |
(196,269 |
) |
|
$ |
(132,599 |
) |
Net loss per common share –
basic and diluted |
$ |
(0.74 |
) |
|
$ |
(0.45 |
) |
|
$ |
(1.34 |
) |
|
$ |
(1.01 |
) |
Weighted-average common shares
outstanding – basic and diluted |
|
146,468,991 |
|
|
|
131,155,642 |
|
|
|
146,313,696 |
|
|
|
130,872,717 |
|
|
IMMUNOVANT, INC.Consolidated Balance
Sheets(Unaudited, in thousands, except share and per share
data) |
|
|
September 30, 2024 |
|
March 31, 2024 |
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
472,941 |
|
|
$ |
635,365 |
|
Accounts receivable |
|
1,876 |
|
|
|
5,337 |
|
Prepaid expenses and other current assets |
|
32,555 |
|
|
|
25,068 |
|
Total current assets |
|
507,372 |
|
|
|
665,770 |
|
Operating lease right-of-use
assets |
|
45 |
|
|
|
133 |
|
Other assets |
|
7,619 |
|
|
|
— |
|
Property and equipment, net |
|
671 |
|
|
|
462 |
|
Total
assets |
$ |
515,707 |
|
|
$ |
666,365 |
|
Liabilities and
Stockholders’ Equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
20,727 |
|
|
$ |
7,155 |
|
Accrued expenses |
|
45,879 |
|
|
|
41,315 |
|
Current portion of operating lease liabilities |
|
47 |
|
|
|
138 |
|
Total current liabilities |
|
66,653 |
|
|
|
48,608 |
|
Total liabilities |
|
66,653 |
|
|
|
48,608 |
|
Commitments and
contingencies |
|
|
|
Stockholders’ equity: |
|
|
|
Series A preferred stock, par value $0.0001 per share, 10,000
shares authorized, issued and outstanding at September 30,
2024 and March 31, 2024 |
|
— |
|
|
|
— |
|
Preferred stock, par value $0.0001 per share, 10,000,000 shares
authorized, no shares issued and outstanding at September 30,
2024 and March 31, 2024 |
|
— |
|
|
|
— |
|
Common stock, par value $0.0001 per share, 500,000,000 shares
authorized, 146,565,049 shares issued and outstanding at
September 30, 2024 and 500,000,000 shares authorized,
145,582,999 shares issued and outstanding at March 31,
2024 |
|
14 |
|
|
|
14 |
|
Additional paid-in capital |
|
1,469,082 |
|
|
|
1,441,518 |
|
Accumulated other comprehensive income |
|
1,910 |
|
|
|
1,908 |
|
Accumulated deficit |
|
(1,021,952 |
) |
|
|
(825,683 |
) |
Total stockholders’ equity |
|
449,054 |
|
|
|
617,757 |
|
Total liabilities and
stockholders’ equity |
$ |
515,707 |
|
|
$ |
666,365 |
|
|
|
|
|
Contact:Renee Barnett, MBAChief Financial
OfficerImmunovant, Inc.info@immunovant.com
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