Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage
immunology company dedicated to enabling normal lives for people
with autoimmune diseases, today reported corporate updates and
financial results for its fiscal second quarter ended September 30,
2023.
“This has been a successful quarter for Immunovant. We delivered
initial Phase 1 data for IMVT-1402, including initial data from the
300 mg MAD cohort ahead of schedule,” said Pete Salzmann, M.D.,
chief executive officer at Immunovant. “We look forward to sharing
initial 600 mg MAD cohort data for IMVT-1402 later this month and
proof-of-concept Phase 2 data for batoclimab in Graves’ disease by
the end of the year.”
Clinical Development
Updates:IMVT-1402:Initial data from the
Phase 1 clinical trial evaluating the safety, tolerability, and
pharmacodynamic profiles of IMVT-1402 in healthy adults showed that
subcutaneously administered doses of IMVT-1402 produced
dose-dependent reductions in Immunoglobulin G, with no
statistically significant dose-related decrease in serum albumin or
increase in LDL cholesterol, strengthening IMVT-1402 as a potential
best-in-class neonatal fragment crystallizable receptor (FcRn)
inhibitor. Initial data from the 600 mg MAD cohorts are expected in
November 2023.
Batoclimab:Immunovant’s subcutaneously
administered FcRn inhibitor, batoclimab, is being developed in four
autoimmune indications – MG, TED, CIDP and Graves’ disease.
Top-line data from the Phase 3 clinical trial in MG are expected in
the second half of calendar year 2024. For the Phase 3 program in
TED, top-line data are expected in the first half of calendar year
2025. Immunovant also expects to have initial results from period 1
of the Phase 2b clinical trial in CIDP in the first half of
calendar year 2024, and initial Phase 2 proof-of-concept data in
Graves’ disease by the end of calendar year 2023.
Corporate Update:On October 2, 2023, the
Company announced the closing of an underwritten public offering
and concurrent private placement offering of common stock yielding
approximately $467 million in net proceeds, after deducting
underwriting commissions and estimated offering expenses. Together
with the Company’s cash and cash equivalents balance of $270
million on September 30, 2023, Immunovant’s pro forma cash and cash
equivalents as of September 30, 2023, totaled approximately $737
million. All the shares in the offering were offered by
Immunovant.
Financial Highlights for Fiscal Second Quarter Ended
September 30, 2023:R&D Expenses:
Research and development expenses were $48.0 million for the three
months ended September 30, 2023, compared to $37.7 million for the
three months ended September 30, 2022. The increase was primarily
due to higher research and development and contract manufacturing
costs related to the development of IMVT-1402, and higher
personnel-related expenses, partially offset by decreased
batoclimab program-specific research and development costs
(including contract manufacturing costs) and lower costs related to
cross-indication clinical studies and clinical research.
G&A Expenses: General and administrative
expenses were $13.8 million for the three months ended September
30, 2023, compared to $11.9 million for the three months ended
September 30, 2022. The increase was primarily due to higher
personnel-related expenses, market research costs, and information
technology costs, partially offset by lower legal and other
professional fees.
Net Loss: Net loss was $58.7 million ($0.45 per
common share) for the three months ended September 30, 2023,
compared to $47.9 million ($0.41 per common share) for the three
months ended September 30, 2022. Net loss for the three months
ended September 30, 2023 and 2022 included $10.5 million and $8.2
million, respectively, related to non-cash stock-based compensation
expense.
Common Stock: As of September 30, 2023, there
were 131,442,024 shares of common stock issued and outstanding. On
October 2, 2023, the Company issued 12,949,184 shares of common
stock as part of the underwritten public equity offering and
private placement offering.
Financial Highlights for Fiscal Six Months Ended
September 30, 2023:R&D Expenses:
Research and development expenses were $98.5 million for the six
months ended September 30, 2023, compared to $66.2 million for the
six months ended September 30, 2022. The increase was primarily due
to higher research and development and contract manufacturing costs
related to the development of IMVT-1402, elevated personnel-related
expenses, and increased batoclimab program-specific research and
development costs (including contract manufacturing costs),
partially offset by lower costs related to cross-indication
clinical studies and clinical research.
IPR&D Expenses: Acquired in-process
research and development expenses were $12.5 million for the six
months ended September 30, 2023, related to the achievement of
development and regulatory milestones for batoclimab as specified
in the HanAll Agreement. There were no acquired in-process research
and development expenses for the six months ended September 30,
2022.
G&A Expenses: General and administrative
expenses were $29.2 million for the six months ended September 30,
2023, compared to $23.8 million for the six months ended September
30, 2022. The increase was primarily due to higher
personnel-related expenses, market research costs, and information
technology costs, partially offset by lower legal and other
professional fees.
Net Loss: Net loss was $132.6 million ($1.01
per common share) for the six months ended September 30, 2023,
compared to $88.3 million ($0.76 per common share) for the six
months ended September 30, 2022. Net loss for the six months ended
September 30, 2023 and 2022 included $21.2 million and $15.8
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 www.immunovant.com.
Forward-Looking StatementsThis 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,” "intend," and other
similar expressions are intended to identify forward-looking
statements. Such forward-looking statements include Immunovant’s
expectations regarding the timing, design, and results of clinical
trials of its product candidates; Immunovant's plan to develop
batoclimab and IMVT-1402 across a broad range of autoimmune
indications; and the potential benefits of batoclimab’s and
IMVT-1402’s unique product attributes. 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: initial results or other
preliminary analyses or results of early clinical trials may not be
predictive final trial results or of the results of later clinical
trials; results of animal studies may not be predictive of results
in humans; 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
timing of the commencement of additional clinical trials and
resumption of current 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 global
factors, such as the post-COVID-19 environment, geopolitical
tensions, and adverse macroeconomic conditions 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 batoclimab and IMVT-1402; Immunovant is at an
early stage of development for IMVT-1402 and in various stages of
clinical development for batoclimab; and Immunovant will require
additional capital to fund its operations and advance batoclimab
and IMVT-1402 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 9,
2023, 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.Condensed Consolidated Statements of
Operations(Unaudited, in thousands, except share and per
share data) |
|
|
Three Months EndedSeptember
30, |
|
Six Months EndedSeptember
30, |
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Operating
expenses: |
|
|
|
|
|
|
|
Research and development |
$ |
47,959 |
|
|
$ |
37,739 |
|
|
$ |
98,534 |
|
|
$ |
66,168 |
|
Acquired in-process research and development |
|
— |
|
|
|
— |
|
|
|
12,500 |
|
|
|
— |
|
General and administrative |
|
13,841 |
|
|
|
11,875 |
|
|
|
29,243 |
|
|
|
23,821 |
|
Total operating expenses |
|
61,800 |
|
|
|
49,614 |
|
|
|
140,277 |
|
|
|
89,989 |
|
Interest income |
|
(3,572 |
) |
|
|
(1,154 |
) |
|
|
(7,637 |
) |
|
|
(1,154 |
) |
Other income, net |
|
(20 |
) |
|
|
(793 |
) |
|
|
(484 |
) |
|
|
(1,147 |
) |
Loss before provision for
income taxes |
|
(58,208 |
) |
|
|
(47,667 |
) |
|
|
(132,156 |
) |
|
|
(87,688 |
) |
Provision for income
taxes |
|
454 |
|
|
|
261 |
|
|
|
443 |
|
|
|
613 |
|
Net loss |
$ |
(58,662 |
) |
|
$ |
(47,928 |
) |
|
$ |
(132,599 |
) |
|
$ |
(88,301 |
) |
Net loss per common share –
basic and diluted |
$ |
(0.45 |
) |
|
$ |
(0.41 |
) |
|
$ |
(1.01 |
) |
|
$ |
(0.76 |
) |
Weighted-average common shares
outstanding – basic and diluted |
|
131,155,642 |
|
|
|
116,572,820 |
|
|
|
130,872,717 |
|
|
|
116,630,076 |
|
IMMUNOVANT, INC.Condensed Consolidated Balance
Sheets(Unaudited, in thousands, except share and per share
data) |
|
|
September 30, 2023 |
|
March 31, 2023 |
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
269,928 |
|
|
$ |
376,532 |
|
Accounts receivable |
|
1,421 |
|
|
|
700 |
|
Prepaid expenses and other current assets |
|
19,828 |
|
|
|
27,101 |
|
Total current assets |
|
291,177 |
|
|
|
404,333 |
|
Operating lease right-of-use
assets |
|
589 |
|
|
|
1,172 |
|
Property and equipment,
net |
|
304 |
|
|
|
333 |
|
Total
assets |
$ |
292,070 |
|
|
$ |
405,838 |
|
Liabilities and
Stockholders’ Equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
7,511 |
|
|
$ |
1,353 |
|
Accrued expenses |
|
32,134 |
|
|
|
40,771 |
|
Current portion of operating lease liabilities |
|
614 |
|
|
|
1,173 |
|
Total current liabilities |
|
40,259 |
|
|
|
43,297 |
|
Operating lease liabilities,
net of current portion |
|
— |
|
|
|
47 |
|
Total liabilities |
|
40,259 |
|
|
|
43,344 |
|
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,
2023 and March 31, 2023 |
|
— |
|
|
|
— |
|
Preferred stock, par value $0.0001 per share, 10,000,000 shares
authorized, no shares issued and outstanding at September 30,
2023 and March 31, 2023 |
|
— |
|
|
|
— |
|
Common stock, par value $0.0001 per share, 500,000,000 shares
authorized, 131,442,024 shares issued and outstanding at
September 30, 2023 and 500,000,000 shares authorized,
130,329,863 shares issued and outstanding at March 31,
2023 |
|
13 |
|
|
|
13 |
|
Additional paid-in capital |
|
950,231 |
|
|
|
927,976 |
|
Accumulated other comprehensive income |
|
513 |
|
|
|
852 |
|
Accumulated deficit |
|
(698,946 |
) |
|
|
(566,347 |
) |
Total stockholders’ equity |
|
251,811 |
|
|
|
362,494 |
|
Total liabilities and
stockholders’ equity |
$ |
292,070 |
|
|
$ |
405,838 |
|
|
|
|
|
Contact:Chau Cheng, PhD, MBAVice President,
Investor RelationsImmunovant, Inc.info@immunovant.com
Jaye Bea SmalleyHead, Patient AdvocacyImmunovant,
Inc.mediarelations@immunovant.com
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