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 first quarter ended June 30, 2023.
“Our strategic priority this past quarter was to advance our
robust clinical programs. To that end, we are pleased that our
Phase 1 clinical trial of IMVT-1402 is on schedule to deliver
initial data in the coming months, and we look forward to sharing
these key first-in-human results with all stakeholders,” said Pete
Salzmann, M.D., chief executive officer at Immunovant.
Clinical Development
Updates:Batoclimab:Immunovant is studying
batoclimab, the company’s lead subcutaneously administered FcRn
inhibitor, in four autoimmune indications – MG, TED, CIDP and GD.
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 GD
in the fourth quarter of calendar year 2023.
IMVT-1402:The Phase 1 clinical trial evaluating
the safety, tolerability, and pharmacodynamic profiles of IMVT-1402
in healthy volunteers is progressing. IMVT-1402 is Immunovant’s
next-generation FcRn inhibitor with a simple subcutaneous
formulation. Initial data from the single-ascending dose cohorts
are on track for September 2023 and initial data from the
multiple-ascending dose cohorts are expected in October/November
2023.
Financial Highlights for Fiscal First Quarter Ended June
30, 2023:Cash Position: As of June 30,
2023, Immunovant’s cash and cash equivalents totaled $330.0
million, which is expected to fund operations into the second half
of calendar year 2025.
R&D Expenses: Research and development
expenses were $50.6 million for the three months ended June 30,
2023, compared to $28.4 million for the three months ended June 30,
2022. The increase was primarily due to higher research and
development and contract manufacturing costs related to the
development of IMVT-1402, increased batoclimab program-specific
research and development costs (including contract manufacturing
costs), and higher personnel-related expenses, 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 three
months ended June 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 three months ended June 30,
2022.
G&A Expenses: General and administrative
expenses were $15.4 million for the three months ended June 30,
2023, compared to $11.9 million for the three months ended June 30,
2022. The increase was primarily due to higher personnel-related
expenses, legal, and other professional fees, information
technology and market research costs.
Net Loss: Net loss was $73.9
million ($0.57 per common share) for the three months
ended June 30, 2023, compared to $40.4
million ($0.35 per common share) for the three months
ended June 30, 2022. Net loss for the three months ended June
30, 2023 and 2022 included $10.7 million and $7.7 million,
respectively, related to non-cash stock-based compensation
expense.
Common Stock: As of June 30, 2023, there were
130,565,429 shares of common stock issued and outstanding.
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; Immunovant's beliefs regarding its cash runway; 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 in
development of 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 most recent Annual Report on Form 10-K, its Form 10-Q
to be filed with the SEC on August 10, 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 EndedJune 30, |
|
|
2023 |
|
|
|
2022 |
|
Operating
expenses: |
|
|
|
Research and development |
$ |
50,575 |
|
|
$ |
28,429 |
|
Acquired in-process research and development |
|
12,500 |
|
|
|
— |
|
General and administrative |
|
15,402 |
|
|
|
11,946 |
|
Total operating expenses |
|
78,477 |
|
|
|
40,375 |
|
Interest income |
|
(4,065 |
) |
|
|
— |
|
Other income |
|
(464 |
) |
|
|
(354 |
) |
Loss before provision
(benefit) for income taxes |
|
(73,948 |
) |
|
|
(40,021 |
) |
Provision (benefit) for income
taxes |
|
(11 |
) |
|
|
352 |
|
Net loss |
$ |
(73,937 |
) |
|
$ |
(40,373 |
) |
Net loss per common share –
basic and diluted |
$ |
(0.57 |
) |
|
$ |
(0.35 |
) |
Weighted-average common shares
outstanding – basic and diluted |
|
130,503,264 |
|
|
|
116,557,508 |
|
|
|
|
|
|
|
|
|
IMMUNOVANT, INC.Condensed Consolidated
Balance Sheets(Unaudited, in thousands, except share and
per share data) |
|
|
|
|
|
|
June 30, 2023 |
|
March 31, 2023 |
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
|
$ |
329,960 |
|
|
$ |
376,532 |
|
Accounts receivable |
|
|
823 |
|
|
|
700 |
|
Prepaid expenses and other current assets |
|
|
19,232 |
|
|
|
27,101 |
|
Total current assets |
|
|
350,015 |
|
|
|
404,333 |
|
Operating lease right-of-use
assets |
|
|
882 |
|
|
|
1,172 |
|
Property and equipment,
net |
|
|
325 |
|
|
|
333 |
|
Total
assets |
|
$ |
351,222 |
|
|
$ |
405,838 |
|
Liabilities and
Stockholders’ Equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
|
$ |
26,459 |
|
|
$ |
1,353 |
|
Accrued expenses |
|
|
23,979 |
|
|
|
40,771 |
|
Current portion of operating lease liabilities |
|
|
919 |
|
|
|
1,173 |
|
Total current liabilities |
|
|
51,357 |
|
|
|
43,297 |
|
Operating lease liabilities,
net of current portion |
|
|
— |
|
|
|
47 |
|
Total liabilities |
|
|
51,357 |
|
|
|
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 June 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 June 30, 2023
and March 31, 2023 |
|
|
— |
|
|
|
— |
|
Common stock, par value $0.0001 per share, 500,000,000 shares
authorized, 130,565,429 shares issued and outstanding at
June 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 |
|
|
939,554 |
|
|
|
927,976 |
|
Accumulated other comprehensive income |
|
|
582 |
|
|
|
852 |
|
Accumulated deficit |
|
|
(640,284 |
) |
|
|
(566,347 |
) |
Total stockholders’ equity |
|
|
299,865 |
|
|
|
362,494 |
|
Total liabilities and
stockholders’ equity |
|
$ |
351,222 |
|
|
$ |
405,838 |
|
|
|
|
|
|
|
|
|
|
Contact:Chau Cheng, PhD, MBAVice President,
Investor RelationsImmunovant, Inc.info@immunovant.com
Immunovant (NASDAQ:IMVT)
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