LAVAL, QC and CAMBRIDGE, England, July 17, 2020 /PRNewswire/ - Liminal BioSciences
Inc. (Nasdaq: LMNL) (TSX: LMNL) ("Liminal BioSciences" or the
"Company"), a clinical-stage biopharmaceutical company, announced
today that it has acquired all of the issued and outstanding shares
in the capital of Fairhaven Pharmaceuticals
Inc. ("Fairhaven"),
thus acquiring a preclinical research program of small
molecule antagonists. Investigational therapies developed in this
program target a key chemoattractant and activator of eosinophils,
which play a key role in Type 2 inflammation-driven diseases
through tissue repair and resolution of
inflammation ("Fairhaven R&D Program").
"This acquisition is a continuation and expansion of our
strategy to build a diverse portfolio of early-stage R&D
programs that complement our established research focus and our
lead development opportunities with Ryplazim® and
fezagepras," stated Kenneth
Galbraith, Chief Executive Officer of Liminal BioSciences.
"We are making progress on our selective GPR84 antagonist R&D
program and we look forward to advancing the promising
Fairhaven R&D Program in our laboratories at Liminal
BioSciences, utilizing our extensive GPCR experience and supported
by funding provided initially by certain Fairhaven shareholders."
The Fairhaven R&D Program is based on the research of Dr.
William Powell, Professor Emeritus
in the Department of Medicine at McGill
University, working in collaboration with Dr. Joshua Rokach of the Florida Institute of Technology (FIT). Drs. Powell
and Rokach developed a series of potentially first-in-class, oral,
selective OXE receptor antagonists against 5-oxo-ETE, one of the
most potent human eosinophil chemoattractants. Migration of
eosinophils to body sites including the lungs and intestines is
mediated by eosinophil chemoattractants such as 5-oxo-ETE.
Eosinophils play a key role in Type 2 inflammation-driven diseases,
including certain respiratory and gastro-intestinal diseases. Dr.
Powell will serve as an advisor to Liminal BioSciences on the
Fairhaven R&D Program.
Eosinophil-related diseases represent a significant area of
unmet need in global health. Several biologics have been approved
for the treatment of eosinophil-related diseases with combined drug
sales in 2018 exceeding US$3 billion.
In addition, a number of other biologics and small molecules are
under active clinical development for eosinophilic-driven diseases,
including antolimab (Allakos).
"Compared to biologics, small molecule OXE receptor antagonists
offer a promising and potentially more cost-effective treatment
option for eosinophilic-driven disorders," stated Dr. Powell. "I am
looking forward to working with Liminal BioSciences to continue
development on this exciting R&D program initiated by work
carried out at McGill University and
FIT."
"The 5-oxo-ETE research program was one of AmorChem's first
university-based research investments and we are very pleased by
the outcome of this transaction, which provides strong further
affirmation of our investment strategy," stated Elizabeth Douville, Founder and Managing Partner
of AmorChem. "When the program was spun off into Fairhaven following a co-investment by Genesys
Capital, the transaction represented the first important step in
the evolution of our portfolio. With Liminal BioSciences' extensive
expertise in small molecules and GPCR's, we believe the 5-oxo-ETE
research program is well positioned for future
development."
"This transaction is a great reflection of the potential for
emerging life sciences companies in Canada. We are pleased that the innovative
platform developed at Fairhaven
will advance under the stewardship of Liminal BioSciences, which
has an outstanding management team and extensive experience in
pre-clinical and clinical research," said Jamie Stiff, Managing Director at Genesys
Capital. "We look forward to watching the continued progress in
advancing the 5-oxo-ETE program under their leadership in the
months and years ahead."
Terms of the Transaction
Under the terms of the
acquisition, the Company will satisfy the aggregate purchase price
of up to C$8 million by the issuance
of common shares in the capital of Liminal BioSciences to the
shareholders of Fairhaven, being
Genesys Ventures III LP ("Genesys"), AMORCHEM, LIMITED
PARTNERSHIP ("AmorChem LP"), MSBi Valorisation Inc. and The
Royal Institution for the Advancement of Learning/McGill University subject to the achievement of
certain pre-determined milestones. On the closing date of the
acquisition, the Company issued an aggregate of 202,308 common
shares in the capital of Liminal, representing C$3.6 million of the aggregate purchase price, to
the shareholders of Fairhaven, at
a price per share equal to the five-trading day volume weighted
average trading price (the "VWAP") of Liminal BioSciences'
common shares on the Toronto Stock Exchange (the "TSX"). The
remainder of the aggregate purchase price payable by the Company to
the sellers is issuable upon, and subject to, achievement of
certain pre-determined research and development milestones, with
any future shares to be issued at a price per share equal to the
five-trading day VWAP of Liminal BioSciences' common shares prior
to such milestone events.
In addition, in connection with the acquisition, Liminal
BioSciences also completed a private placement with Genesys,
AmorChem LP and AmorChem II Fund L.P. (together with AmorChem LP,
"AmorChem", and together with Genesys,
the "Holders") of C$2.4 million aggregate principal amount of
secured convertible debentures (the "Debentures"), with
an interest rate of 8% per annum, compounded quarterly, for the
continued development of the Fairhaven R&D Program. The
Debentures mature on March 31, 2022
(the "Maturity Date"), unless converted into common shares
of the Company prior to the Maturity Date. At any time prior to the
Maturity Date, the Holders shall have a collective right to, and
Liminal BioSciences shall have the right upon certain
pre-determined events to require each Holder to, purchase
additional Debentures for an aggregate principal amount of up to
C$5.74 million. The Debentures
may be converted into common shares of Liminal BioSciences at the
option of the Company subject to certain conditions, or at the
option of the Holders at any time on, or before the Maturity Date,
at a conversion price equal to the five-trading day VWAP of Liminal
BioSciences' common shares on the TSX prior to the conversion
date.
About Liminal BioSciences Inc.
Liminal BioSciences is
a clinical-stage biopharmaceutical company focused on discovering,
developing and commercializing novel treatments for patients
suffering from diseases related to fibrosis, including respiratory,
liver and kidney diseases that have high unmet medical need.
Liminal BioSciences has a deep understanding of certain biological
targets and pathways that have been implicated in the fibrotic
process, including fatty acid receptors such as FFAR1, or GPR40,
G-protein-coupled receptor 84, or GPR84, and peroxisome
proliferator-activated receptors, or PPARs. Our lead small molecule
product candidate, fezagepras (PBI-4050), is expected to enter an
additional Phase 1 clinical trial in 2H-2020 to evaluate multiple
ascending doses of fezagepras in both healthy volunteers and
patients, at daily dose exposures higher than those evaluated in
our previously completed Phase 2 clinical trials. The optimal dose
and dosing regimen of fezagepras is expected to be further
evaluated in Phase 2 clinical trials in selected fibrosis
indications to be initiated in 2021.
Liminal BioSciences has also leveraged its experience in
bioseparation technologies through its subsidiary Prometic
Bioproduction Inc. to isolate and purify biopharmaceuticals from
human plasma. Our lead plasma-derived product candidate is
Ryplazim® (plasminogen), for which the Company
expects to resubmit a BLA in Q3-2020 with the FDA seeking approval
to treat patients with congenital plasminogen deficiency.
Ryplazim® (plasminogen) has been granted Orphan Drug
Designation and Rare Pediatric Disease Designation by the FDA for
the treatment of congenital plasminogen deficiency.
Prometic Plasma Resources, a subsidiary of Liminal BioSciences
Inc., has joined the CoVIg-19 Plasma Alliance to contribute to the
acceleration of the development of a potential new therapy for
COVID-19. Our Canadian center located in Winnipeg, Manitoba is licensed by the FDA and
Health Canada, and is certified by the European Union and the
Plasma Protein Therapeutics Association (PPTA). Our American center
located in Amherst, New York is
licensed by the State of New York
and its' BLA submission is currently under review by the FDA.
Liminal BioSciences has active business operations in
Canada, the United Kingdom and the United States.
About Amorchem
AmorChem (www.amorchem.com) is a
leading early stage venture capital fund launched in 2011 in
Montreal. The AmorChem team
utilizes its deep understanding of fundamental science to uncover
its therapeutic potential and focuses its core expertise in
translational research to accelerate therapeutic drug discovery and
development across a broad spectrum of disease areas. The fund
capitalizes on both its venture capital expertise and its
entrepreneurial experience to spark the creation of start-up
companies and help shape them into the next generation of biotech
companies. With over $85M under
management, AmorChem has financed over 30 university projects and
started up several biotechnology companies from the fruits of this
innovative research.
About Genesys Capital
Genesys Capital
(www.genesyscapital.com) is one of the largest Canadian-based
venture capital firms exclusively focused on the life sciences
industry. For over 20 years, Genesys has been focused on building
companies in the high-growth sectors of healthcare and
biotechnology. Through its expertise and network, Genesys
accelerates the development of commercially viable emerging
companies that represent promising life sciences investment
opportunities.
Forward Looking Statement
This press release contains
forward-looking information within the meaning of securities laws.
Specific forward–looking information in this press release includes
statements concerning, among other things, Liminal BioSciences'
objectives, strategies and businesses, the anticipated benefits of
the acquisition and the private placement, the manner in which the
Company expects to satisfy the remaining purchase price for the
acquisition, the achievement of the milestone events and timing for
the issuance of additional common shares, the issuance of
additional Debentures, statements with respect to the timing of any
planned BLA resubmission, development of R&D programs and the
Fairhaven R&D Program, the timing of initiation of clinical
trials, the exploration of alternatives for the future
commercialization of Ryplazim®, if approved, including through a
third-party marketing collaboration, and the potential commercial
launch of Ryplazim®, if approved.
Forward-looking information is based on our current expectations
about the markets we operate in and on various estimates and
assumptions. Although the forward-looking information is based on
information management believes to be reasonable assumptions, the
Company cannot assure investors that actual results will be
consistent with such information.
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. At this stage, the product candidates of
the Company have not been authorized for sale in any country. The
risks, and factors that could cause actual results to differ
materially from those described or projected herein include, but
are not limited to, Liminal BioSciences' ability to develop,
manufacture, and successfully commercialize product candidates if
ever, the impact of the COVID-19 crisis on its business operations,
clinical development, regulatory activities and financial and other
corporate impacts, the availability of funds and resources to
pursue R&D projects, the successful and timely completion of
clinical trials, the ability of Liminal BioSciences to take
advantage of business opportunities in the pharmaceutical industry,
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 Company's U.S. Securities and
Exchange Commission and Canadian securities filings and reports
available under the Company's profile on SEDAR at www.sedar.com,
including in the Annual Report on Form 20-F for the year ended
December 31, 2019. As a result, we
cannot guarantee that any forward-looking statement will
materialize. Such risks may be amplified by the COVID-19 pandemic
and its potential impact on Liminal BioSciences' business and the
global economy. Existing and prospective investors are cautioned
not to place undue reliance on these forward-looking statements,
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.