- Provided R&D update on GPCR-targeted pipeline, including
nomination of lead candidate for OXER1 antagonist program
- Closed June 30, 2023 with over
CAD 19 million cash on hand,
expecting to provide cash runway into December 2023
- Net loss from continuing operations of CAD 9 million during the quarter
ended June, 2023 compared to CAD 6.4
million during the second quarter of 2022
- Entry into Arrangement Agreement with Structured
Alpha LP potentially providing minority shareholders
US$8.50 in cash per Common
Share
LAVAL, QC and CAMBRIDGE, England, Aug. 8, 2023 /PRNewswire/ -- Liminal BioSciences
Inc. (Nasdaq: LMNL) ("Liminal BioSciences" or the
"Company"), a development-stage biopharmaceutical company
focused on discovering and developing distinctive novel small
molecule therapeutics for metabolic, inflammatory, and fibrotic
diseases, today reported its financial results for the second
quarter ended June 30,
2023.
"I am very pleased with the progress we have made in the past
quarter, marking a significant leap forward in our mission to
develop novel treatments for metabolic, fibrotic and inflammatory
conditions," stated Bruce Pritchard,
Chief Executive Officer of Liminal BioSciences. "Our dedication to
innovation and scientific excellence has led to several key
milestones, bringing us closer to clinical studies in which we aim
to seek early biological validation of our assets."
Recent R&D milestones
- LMNL6326 was nominated as the lead preclinical candidate for
our OXER1 antagonist development program, targeting the treatment
of eosinophil-driven diseases.
- Advancement of clinical trial application (CTA) enabling
preclinical studies of LMNL6511 to support CTA filing for Phase 1
clinical trial in H2 2023.
- Insights gained from In Vivo preclinical studies of LMNL6511 to
further refine potential indications' spectrum.
- GPR40 agonist development program on track and the Company aims
to identify potent, low molecular weight GPR40 agonists without
significant PPARy activity in 2023.
Upcoming R&D Milestones
GPR84 antagonist program
- On-going In-vivo experiments expected to narrow down selection
of a lead clinical indication in 2023.
Ongoing Clinical Trial Application (CTA)-enabling studies for
first-in-human clinical trial in 2023.
- Expect to file CTA for first in-human Phase 1 clinical
trial and to commence clinical trial in H2 2023.
OXER1 antagonist program
- Aim to file CTA/Investigational New Drug (IND) for LMNL6326
first-in-human clinical trial in 2024.
GPR40 antagonist program
- Aim to identify potent, low molecular weight GPR40 agonists
without significant PPARγ activity in 2023.
Arrangement with SALP
On July 11, 2023, we entered into
a definitive arrangement agreement (the "Arrangement Agreement")
with Structured Alpha LP ("SALP") under which SALP will acquire all
of the issued and outstanding common shares of Liminal BioSciences
(the "Common Shares") that it does not already own, subject to
customary closing conditions. The transaction will be implemented
by way of plan of arrangement under the Canada Business
Corporations Act. Under the terms of the Arrangement Agreement,
Liminal BioSciences shareholders (other than SALP and its
affiliates or associates) will receive US$8.50 in cash per Common Share. Liminal
BioSciences intends to mail a management information circular to
its shareholders in the coming weeks for the special meeting of
shareholders anticipated to be held virtually on September 15, 2023 to approve the proposed
transaction. The transaction is expected to close no later than
September 30, 2023, subject to
satisfaction of customary closing conditions. The transaction is
not subject to any financing condition.
Second Quarter Ended June
30th 2023 Financial Results
All figures
presented in this section are in Canadian dollars.
- Cash and cash equivalents were $19.3 million at June 30,
2023 while our working capital, i.e., the current assets net
of current liabilities, was $16.4
million.
- Research and development expenses were $4.3 million during the second quarter of 2023
compared to $3.9 million for the
second quarter of 2022. The increase of $0.4
million in R&D expenses during the quarter ended
June 30, 2023 compared to the
corresponding period in 2022 was mainly attributable to an increase
of $0.7 million in preclinical
studies expense associated with the advancement of our GPR84 and
OXER1 antagonist programs. This increase was partially offset by a
$0.3 million decrease in personnel
costs due to reductions in our workforce.
- Administration expenses were $4.8 million for the second quarter of 2023
compared to $4.5 million for the
second quarter of 2022. The decrease of $0.3
million in administration expenses during the quarter ended
June 30, 2023 compared to the
corresponding period in 2022 was mainly attributable to an increase
of $0.9 million in professional fees
incurred in connection with the non-binding proposal received from
SALP, which was partially offset by a $0.6
million decrease in reduced directors' and officers'
insurance premiums.
- Net loss from continuing operations, net of taxes was
$9.0 million for the second quarter
of 2023 compared to $6.3 million for
the second quarter of 2022. This decrease of $2.6 million was mainly driven by the decrease in
foreign exchange gains of $1.7
million, a decrease in the gains from the change in fair
value of the warrant liability that is measured at FVPL of
$1.3 million, an increase in
administration expenses of $0.3
million reflecting the increase in professional fees and an
increase in R&D expenses of $0.4
million as a result of an increase in preclinical studies
expense associated with the advancement of our GPR84 and OXER1
antagonist programs. These increases in expenses were partially
offset by a $1.0 million decrease in
finance costs.
- Total loss from discontinued operations Total loss from
discontinued operations was $0.2
million during the quarter ended June
30, 2023 compared to a total income from discontinued
operations of $0.1 million during the
corresponding period in 2022. This variation was mainly
attributable to to changes in the underlying assumptions used to
value the provision pertaining to the CDMO.
- Net Loss was $9.1 million
for the second quarter of 2023 compared to $6.2 million for the second quarter of 2022. This
increase in the net loss was mainly driven by the decrease in
foreign exchange gains of $1.7
million, a decrease in the gains from the change in fair
value of the warrant liability that is measured at FVPL of
$1.3 million, an increase in
administration expenses of $0.3
million reflecting the increase in professional fees and an
increase in R&D expenses of $0.4
million as a result of an increase in preclinical studies
expense associated with the advancement of our GPR84 and OXER1
antagonist programs. These increases in expenses were partially
offset by a $1.0 million decrease in
finance costs.
About Liminal BioSciences Inc.
Liminal BioSciences is a development-stage biopharmaceutical
company focused on discovering and developing novel and distinctive
small molecule therapeutics that modulate G protein-coupled
receptor pathways (GPCRs). The Company is designing proprietary
novel small molecule therapeutic candidates with the intent of
developing best/first in class therapeutics for the treatment of
metabolic, inflammatory and fibrotic diseases with significant
unmet medical needs, using its integrated drug discovery platform,
medicinal chemistry expertise and deep understanding of GPCR
biology. The Company's pipeline is currently made up of three
programs. LMNL6511, a selective antagonist for the GPR84 receptor,
is expected to commence a Phase 1 clinical trial in the second half
of 2023. LMNL6326 has been nominated as the preclinical candidate
for its OXER1 antagonist program, and the Company is also
developing GPR40 agonists. Both the OXER1 antagonist program
and GPR40 agonist program are currently in the preclinical stage.
In addition to these programs, the Company continues to explore
other development opportunities to add to its pipeline.
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' candidates or development programs, including
the timing and outcome of the potential development of the
Company's R&D programs such as the development of LMNL6511,
LMNL6326 and our GPR40 agonist discovery program; the timing of
initiation or nature of preclinical and clinical trials, including
the expected commencement of a Phase 1 clinical trial of LMNL6511
in the second half of 2023; the contemplated potential therapeutic
areas, including Eosinophilic mediated diseases and T2D; the
potential for our development programs to address significant unmet
medical needs; our ability to add new development opportunities to
our pipeline; our ability to continue to comply with Nasdaq Listing
Rule 5450(a)(1) to remain listed on the Nasdaq Capital
Market; the ability to complete and the timing of completion
of the transactions contemplated by the arrangement agreement
between Liminal BioSciences and SALP, including the parties'
ability to satisfy the conditions to the consummation of the
transaction and the possibility of any termination of the
agreement; our expected cash runway and our ability to
actively seek and close on opportunities to monetize non-core
assets or commercial opportunities related to our assets. 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 current global economic conditions and other
geopolitical tensions 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 opportunities; the
successful and timely initiation or completion of preclinical and
clinical trials; the ability to take advantage of financing
opportunities or business opportunities in the pharmaceutical
industry, uncertainties associated generally with research and
development, clinical trials and related regulatory reviews and
approvals; our ability to comply with Nasdaq listing rules and
remain listed on the Nasdaq Capital Market and general changes in
economic conditions, including as a result of increased inflation,
bank failures and rising interest rates. 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,
2022, as well as other filings and reports Liminal
Biosciences' may make from time to time. 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.
Nicole Rusaw, Chief Financial
Officer, n.rusaw@liminalbiosciences.com
View original
content:https://www.prnewswire.co.uk/news-releases/liminal-biosciences-reports-second-quarter-financial-results-2023-301896134.html