- Planned Phase 1a Single Ascending Dose ("SAD") clinical
trial of fezagepras expected to commence in Q2 2022
- Completion of analysis of safety and pharmacokinetic ("PK")
data from Phase 1 Multiple Ascending Dose ("MAD") clinical trial of
fezagepras
- Repayment in full of the $39.1M secured loans and release of security on
the Company's assets
- Net loss of $11.2 million
during the quarter ended March 31,
2022 compared to $20.8 million
during the quarter ended March 31,
2021
LAVAL,
QC and CAMBRIDGE,
England, May 10, 2022 /CNW/ - Liminal BioSciences
Inc. (NASDAQ: LMNL) ("Liminal BioSciences" or the "Company"), today
reported its financial results for the first quarter ended
March 31, 2022.
"We have already made significant progress in the first quarter
of 2022 having eliminated the Company's debt and refined our
data-driven development plan for our pipeline," stated Bruce Pritchard, Chief Executive Officer of
Liminal BioSciences. "We look forward to providing more information
on the outcome of the planned Phase 1a SAD clinical trial of
fezagepras designed as a head-to-head comparison with sodium
phenylbutyrate, in the third quarter of 2022. In addition, we have
also made significant progress in the identification of high
potency, small molecule antagonists of GPR84, including potential
selective candidates for development from different structural
classes to those GPR84 antagonists for which data has already been
published. We expect to continue building on this momentum for the
remainder of 2022. We will also continue to seek opportunities to
streamline our corporate structure and monetize non-core assets as
we work to deliver on our objective to build value for our
shareholders."
First Quarter 2022 Financial Results
All figures
presented in this section are in Canadian dollars.
- Cash was $61.2 million
at March 31, 2022 while our working capital, i.e., the
current assets net of current liabilities, was $42.7 million. During the first quarter of 2022,
we repaid our secured loans for an aggregate amount of $39.1 million, thereby terminating the
consolidated loan agreement with Structure Alpha LP ("SALP"),
releasing the security granted in favor of SALP over the Company's
assets, including intellectual property, cancelling the warrants
issued pursuant to the restructuring agreement and terminating the
royalty stream agreement entered into between us and SALP.
- Research and development expenses were $4.4 million for the
first quarter of 2022 compared to $4.9 million for the first quarter of 2021.
The decrease in R&D expenses is mainly due to a decrease
in third party clinical trial expense of $1.3 million which was partially offset by an
increase in third party preclinical studies costs of $0.3 million, the absence of government grant
credits recorded in the current period compared to $0.4 million in the comparative period and the
recognition of an expense related to an upfront payment made under
a royalty stream agreement of $0.4
million.
- Administration expenses were $4.9 million for the first quarter of 2022
compared to $8.1 million for the
first quarter of 2021, representing a decrease of 40%. The
decrease in administration expenses is primarily due to a decrease
of $2.5 million in expense as a
result of reduced directors' and officers' insurance premiums
resulting from the change in the Company's registered office from
Quebec to Ontario in the later part of 2021 and a
reduction in share-based payment expense of $0.6 million.
- Net loss from continuing operations, net of
taxes was $11.4 million for
the first quarter of 2022 compared to $14.0
million for the first quarter of 2021. The decrease in
loss was mainly due to the reduction in administration
expenses.
- Total Income (Loss) from
discontinued operations was an income of $0.2 million for the first quarter of 2022
compared to a loss of $6.8 million in
the first quarter of 2021. This decrease was mainly due to the fact
that we had the full quarter impact of operations of the
plasma-derived therapeutics segment during the quarter ended
March 31, 2021, where during the
quarter ended March 31, 2022, our
discontinued operations income or losses were mainly affected by
changes in the contract and development manufacturing organization
lease liability and provision, remnants of the plasma-derived
therapeutic segment, caused by increases in the inflation rate and
variations in the discount rate.
- Net loss was a loss of $11.2
million for the first quarter of 2022 compared to a loss of
$20.8 million for the first quarter
of 2021.
About Liminal BioSciences Inc.
Liminal BioSciences is a clinical stage biopharmaceutical
company focused on developing distinctive novel small molecule
therapeutics for inflammatory, fibrotic, and metabolic diseases
using our drug discovery platform and a data driven approach. The
Company's lead small molecule product candidate, fezagepras, has
completed a Phase 1 MAD clinical trial and the Company anticipates
conducting a Phase 1a SAD clinical trial in Q2 2022 to provide
comparative data to support its development plan. In addition, the
Company is also currently developing a selective GPR84 antagonist
candidate and a selective OXER1 antagonist candidate. Our GPR84 and
OXER1 antagonist programs are currently at the preclinical
stage.
Liminal BioSciences has active business operations in
Canada and the United Kingdom.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. Some of the forward-looking statements can be identified
by the use of forward-looking words. Statements that are not
historical in nature, including the words "anticipate," "expect,"
"suggest," "plan," "believe," "intend," "estimate," "target,"
"project," "should," "could," "would," "may," "will," "forecast"
and other similar expressions are intended to identify
forward-looking statements. These statements include those related
to Liminal BioSciences' objectives, strategies and businesses that
involve risks and uncertainties. Forward–looking information
includes statements concerning, among other things: advancement of
Liminal Biosciences' product candidates, the outcome of anticipated
clinical trials; the analysis of our clinical trial data; the
potential development of Liminal Biosciences' R&D programs; the
properties of our drug candidates; the timing of initiation or
nature of preclinical and clinical trials and potential therapeutic
areas; our ability to identify opportunities to streamline
our corporate structure and monetize non-core assets and close on
such opportunities or our ability to build value for our
shareholders and reduce costs relating to contracts associated with
the previous operations of the organization.
These statements are "forward-looking" because they are based on
our current expectations about the markets we operate in and on
various estimates and assumptions. Actual events or results may
differ materially from those anticipated in these forward-looking
statements if known or unknown risks affect our business, or if our
estimates or assumptions turn out to be inaccurate. Among the
factors that could cause actual results to differ materially from
those described or projected herein include, but are not limited
to, risks associated with: the Company's ability to develop,
manufacture, and successfully commercialize product candidates, if
ever; the impact of the COVID-19 pandemic on the Company's
workforce, business operations, clinical development, regulatory
activities and financial and other corporate impacts; the
availability of funds and resources to pursue R&D projects,
clinical development, manufacturing operations or commercialization
activities; the successful and timely initiation or completion of
clinical trials; the ability to take advantage of financing
opportunities or business opportunities in the pharmaceutical
industry; the Company's ability to resolve the Nasdaq listing
deficiency and regain compliance with the Nasdaq Listing Rules;
uncertainties associated generally with research and development,
clinical trials and related regulatory reviews and approvals; and
general changes in economic conditions. You will find a more
detailed assessment of these risks, uncertainties and other risks
that could cause actual events or results to materially differ from
our current expectations in the filings and reports the Company
makes with the U.S. Securities and Exchange Commission and Canadian
Securities Administrators, including in the Annual Report on Form
20-F for the year ended December 31,
2021, as well as other filings and reports Liminal
Biosciences' may make from time to time. Such risks may be
amplified by the ongoing COVID-19 pandemic and any related impacts
on Liminal BioSciences' business and the global economy. As a
result, we cannot guarantee that any given forward-looking
statement will materialize. Existing and prospective investors are
cautioned not to place undue reliance on these forward-looking
statements and estimates, which speak only as of the date hereof.
We assume no obligation to update any forward-looking statement
contained in this press release even if new information becomes
available, as a result of future events or for any other reason,
unless required by applicable securities laws and regulations.
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SOURCE Liminal BioSciences Inc.