LMNL Liminal BioSciences Inc.

1.24
-0.11  -8%
Previous Close 1.35
Open 1.31
52 Week Low 1.21
52 Week High 7.07
Market Cap $38,492,774
Shares 23,622,660
Float 11,139,894
Enterprise Value $-317,152
Volume 260,306
Av. Daily Volume 139,859
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Drug Pipeline

Drug Stage Notes
RYPLAZIM (plasminogen)
Congenital plasminogen deficiency (C-PLGD)
Approved
Approved
FDA approval announced June 4, 2021.
Fezagepras
Hypertriglyceridemia
Phase 1/2
Phase 1/2
Phase 1b/2a trial will not longer be initiated - noted May 28, 2021.
Fezagepras
Idiopathic pulmonary fibrosis (IPF)
Phase 1
Phase 1
Phase 2 trial will no longer be initiated - May 28, 2021.

Latest News

    • Closing of the Sale of a Rare Pediatric Disease Priority Review Voucher for gross proceeds of USD105M
    • Closing of the Sale of the Remaining Plasma-Derived Therapeutics Business to Kedrion S.p.A
    • Completion of the Clinical Phase of the Phase 1 Multi-Ascending Dose Clinical Trial in Fezagepras

    LAVAL, QC and CAMBRIDGE, England, Nov. 15, 2021 /PRNewswire/ - Liminal BioSciences Inc. (NASDAQ:LMNL) ("Liminal BioSciences" or the "Company"), today reported its financial results for the third quarter ended September 30, 2021.

    "In addition to adding a significant sum of cash to our balance sheet this quarter, we have also removed significant costs from our operations due to the divestment of our remaining plasma-derived therapeutics business," stated…

    • Closing of the Sale of a Rare Pediatric Disease Priority Review Voucher for gross proceeds of USD105M
    • Closing of the Sale of the Remaining Plasma-Derived Therapeutics Business to Kedrion S.p.A
    • Completion of the Clinical Phase of the Phase 1 Multi-Ascending Dose Clinical Trial in Fezagepras

    LAVAL, QC and CAMBRIDGE, England, Nov. 15, 2021 /PRNewswire/ - Liminal BioSciences Inc. (NASDAQ:LMNL) ("Liminal BioSciences" or the "Company"), today reported its financial results for the third quarter ended September 30, 2021.

    "In addition to adding a significant sum of cash to our balance sheet this quarter, we have also removed significant costs from our operations due to the divestment of our remaining plasma-derived therapeutics business," stated Bruce Pritchard, Chief Executive Officer of Liminal BioSciences. "We now look forward to focusing all of our efforts and resources on our small molecules R&D strategy and the review of the complete data from the fezagepras Phase 1 multi-ascending dose clinical trial, and expect to complete our evaluation by the end of the fourth quarter 2021."

    For a more complete description of the Prometic Biotherapeutics Inc. ("PBT") divestment, please see the Company's reports filed with the U.S. Securities and Exchange Commission (www.sec.gov) and with the Canadian Securities Administrators (www.sedar.com).

    Key Corporate and R&D Priorities

    Liminal BioSciences continues to take precautionary measures in response to the ongoing COVID-19 pandemic to protect the health of its employees and their families, patients, subjects involved in Phase 1 clinical trials and local communities. The Company has had only limited disruptions to its business operations related to the COVID-19 pandemic and provides the following update:

    • The Company has completed the clinical phase of its Phase 1 multi-ascending dose ("MAD") clinical trial and is in the process of evaluating the complete pharmacokinetic ("PK") data set from the Phase 1 MAD clinical trial and expects to complete this analysis before the end of the fourth quarter of 2021. The Company anticipates updating the market on any further development plans for fezagepras during the first quarter of 2022.

    Select Third Quarter 2021 Financial Results

    The Company has presented the current and comparative period results of its former plasma-derived therapeutics segment as discontinued operations as a result of its divestment of this business. All figures presented in this section are in Canadian dollars unless otherwise specified.

    • Cash was $116.7 million at September 30, 2021 while the Company's working capital, i.e., the current assets net of current liabilities, was $113.3 million at September 30, 2021.
    • Research and development (R&D) expenses from continuing operations were $5.0 million for the third quarter of 2021 compared to $3.3 million for the third quarter of 2020. The increased cost is associated with the Phase 1 MAD clinical trial for fezagepras that started in December 2020, as well as other increases in preclinical and amortization costs with a decrease in government grants. These increases were partially offset by a decrease in share-based payment expense of $0.5 million.
    • Administration expenses from continuing operations were $9.4 million for the third quarter of 2021 compared to $7.5 million for the third quarter of 2020. The increase is due to higher directors and officers insurance expense, bonus and termination benefit costs and a reduction in government grants. These increases were partially offset by a decrease in consulting fees. 
    • Finance costs were $1.9 million for the third quarter of 2021 compared to $0.8 million for the third quarter of 2020, as a result of the long-term debt issuances in the third quarter of 2020.
    • Net loss from continuing operations, net of taxes was $9.7 million for the third quarter of 2021 compared to $11.3 million for the third quarter of 2020. The decrease in loss was mainly due to the gain on the change in fair value of the warrant liability of $5.1 million and a foreign exchange gain of $1.3 million which exceeded the increases in R&D, administration expenses and finance costs.
    • Gain on Sale of Subsidiaries was $129.8 million for the third quarter of 2021 compared to nil in 2020, as a result of the sale of the Priority Review Voucher ("PRV") for gross proceeds of $132.9 million (USD 105 million) and the proceeds received on the sale of our subsidiary Prometic Bioproduction Inc. ("PBP") in July 2021.
    • Loss from discontinued operations was $37.9 million for the third quarter of 2021 compared to $12.0 million in 2020. The increase is primarly due to a payment made by PBT to PBP, which is now under Kedrion S.p.A ownership, of $39.5 million, representing 30% of the net PRV proceeds, for past R&D services. This increase was partially offset by a gain of $2.5 million as a result of a reduction in the term of a lease. In addition, operating expenses were lower by comparison since PBP was only included in the results of the quarter up until the date of sale on July 9, 2021. The Company also had lower operating expenses as a result of the closing of its Rockville, MD, USA facility at the end of 2020.
    • Net income was $82.3 million for the third quarter of 2021 compared to a loss of $23.3 million for the third quarter of 2020. 

    About Liminal BioSciences Inc.

    Liminal BioSciences is a biopharmaceutical company focused on the discovery and development of novel, small molecule drug candidates for the treatment of patients suffering from fibrotic or inflammatory diseases that have a high unmet medical need. The Company's lead small molecule product candidate, fezagepras (PBI-4050), has completed the clinical phase of the Phase 1 MAD clinical trial and the Company is in the process of evaluating the complete PK data set from the phase 1 MAD clinical trial, and expects to complete this analysis before the end of the fourth quarter of 2021. The Company anticipates updating the market on any further development plans for fezagepras during the first quarter of 2022. In addition, the Company is also currently developing a selective GPR84 antagonist candidate and an oral, 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," "suggests," "plan," "believe," "intend," "estimates," "targets," "projects," "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 the analysis of the Phase 1 multi-ascending dose clinical trial; the potential development of Liminal Biosciences' R&D programs and the timing of initiation or nature of preclinical and clinical trials.

    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 of Liminal BioSciences 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; 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 Commissions, including in the Annual Report on Form 20-F for the year ended December 31, 2020, 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.

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  1. LAVAL, QC and CAMBRIDGE, England, Oct. 15, 2021 /PRNewswire/ - Liminal BioSciences Inc. (NASDAQ:LMNL) ("Liminal BioSciences" or the "Company"), announced today that it has closed on the sale of the remainder of the Company's plasma-derived therapeutics business (the "Second Closing") under the terms of the previously-announced Share Purchase Agreement entered into by the Company and Kedrion S.p.A. ("Kedrion").

    This sale included the Ryplazim® (plasminogen, human-tvmh) ("Ryplazim®") business operated through Liminal BioSciences' subsidiary, Prometic Biotherapeutics Inc. ("PBT"), holder of the biological license application ("BLA") for Ryplazim®. The consideration received by Liminal BioSciences upon the Second Closing was USD 5.5 million, subject…

    LAVAL, QC and CAMBRIDGE, England, Oct. 15, 2021 /PRNewswire/ - Liminal BioSciences Inc. (NASDAQ:LMNL) ("Liminal BioSciences" or the "Company"), announced today that it has closed on the sale of the remainder of the Company's plasma-derived therapeutics business (the "Second Closing") under the terms of the previously-announced Share Purchase Agreement entered into by the Company and Kedrion S.p.A. ("Kedrion").

    This sale included the Ryplazim® (plasminogen, human-tvmh) ("Ryplazim®") business operated through Liminal BioSciences' subsidiary, Prometic Biotherapeutics Inc. ("PBT"), holder of the biological license application ("BLA") for Ryplazim®. The consideration received by Liminal BioSciences upon the Second Closing was USD 5.5 million, subject to adjustments. Under the terms of the Share Purchase Agreement, PBT paid Prometic Bioproduction Inc. ("PBP"), an affiliate of Kedrion, USD 5 million in consideration for services to be received from PBP. Liminal BioSciences has generated total consideration from the divestment of its plasma-derived therapeutics business, including the sale of its priority review voucher, PBT, PBP and its plasma collection centres, net of payments that were made to third parties, including PBP, of approximately USD 100.2 million.

    About Liminal BioSciences Inc.

    Liminal BioSciences is a biopharmaceutical company focused on the discovery and development of novel, small molecule drug candidates for the treatment of patients suffering from respiratory fibrotic diseases and other fibrotic or inflammatory diseases that have a high unmet medical need.  The Company's lead small molecule product candidate, fezagepras (PBI-4050), is in a Phase 1 clinical trial in in the United Kingdom to evaluate multiple-ascending doses in normal healthy volunteers, at daily dose exposures higher than those evaluated in our previously completed Phase 2 clinical trials. The Company expects that a full analysis of the complete PK data set from the phase 1 multi-ascending dose clinical trial will help determine the choice of other potential indications for further development of fezagepras. In addition, the Company is also currently developing a selective GPR84 antagonist candidate and an oral, selective OXER1 antagonist candidate. Our GPR84 and OXER1 antagonist programs are currently at the pre-clinical stage.

    Liminal BioSciences has active business operations in Canada and the United Kingdom.

    Forward-Looking Statement

    This press release contains forward-looking statements about Liminal BioSciences' objectives, strategies and businesses that involve risks and uncertainties. Forward‐looking information includes statements concerning, among other things, statements with respect to the potential of our product candidates and development of R&D programs and the timing of initiation or nature of pre-clinical and clinical trials.

    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 business operations, clinical development, regulatory activities and financial and other corporate impacts; the availability of funds and resources to pursue R&D projects, manufacturing operations or commercialization activities; the successful and timely initiation or completion of clinical trials; the ability of Liminal BioSciences 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; 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 Commissions, including in the Annual Report on Form 20-F for the year ended December 31, 2020 and future filings and reports by the Company, 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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  2. LAVAL, QC and CAMBRIDGE, England, Sept. 28, 2021 /PRNewswire/ - Liminal BioSciences Inc. (NASDAQ:LMNL) ("Liminal BioSciences" or the "Company"), announced today that its subsidiary Prometic Biotherapeutics Inc. ("PBT") has closed on the sale of its Priority Review Voucher ("PRV") for USD 105 million.

    Under the terms of the previously announced Share Purchase Agreement entered into with Kedrion S.p.A. ("Kedrion"), the consideration to be received by Liminal for the PRV sale is seventy percent (70%) of the net proceeds which is payable to Liminal by its subsidiary PBT.

    The company anticipates using the proceeds to be received by Liminal to advance the continued development of our small molecule pipeline, and we plan to update the market regarding…

    LAVAL, QC and CAMBRIDGE, England, Sept. 28, 2021 /PRNewswire/ - Liminal BioSciences Inc. (NASDAQ:LMNL) ("Liminal BioSciences" or the "Company"), announced today that its subsidiary Prometic Biotherapeutics Inc. ("PBT") has closed on the sale of its Priority Review Voucher ("PRV") for USD 105 million.

    Under the terms of the previously announced Share Purchase Agreement entered into with Kedrion S.p.A. ("Kedrion"), the consideration to be received by Liminal for the PRV sale is seventy percent (70%) of the net proceeds which is payable to Liminal by its subsidiary PBT.

    The company anticipates using the proceeds to be received by Liminal to advance the continued development of our small molecule pipeline, and we plan to update the market regarding our small molecules R&D strategy in the coming months following the review of the complete data from the ongoing fezagepras phase 1 multi-ascending dose clinical trial.

    About Liminal BioSciences Inc.

    Liminal BioSciences is a biopharmaceutical company focused on the discovery and development of novel, small molecule drug candidates for the treatment of patients suffering from respiratory fibrotic diseases and other fibrotic or inflammatory diseases that have a high unmet medical need.  The Company's lead small molecule product candidate, fezagepras (PBI-4050), is in a Phase 1 clinical trial in in the United Kingdom to evaluate multiple-ascending doses in normal healthy volunteers, at daily dose exposures higher than those evaluated in our previously completed Phase 2 clinical trials. The Company expects that a full analysis of the complete PK data set from the phase 1 multi-ascending dose clinical trial will help determine the choice of other potential indications for further development of fezagepras. In addition, the Company is also currently developing a selective GPR84 antagonist candidate and an oral, selective OXER1 antagonist candidate. Our GPR84 and OXER1 antagonist programs are currently at the pre-clinical stage.

    Liminal BioSciences has active business operations in Canada and the United Kingdom.

    Forward-Looking Statement

    This press release contains forward-looking statements about Liminal BioSciences' objectives, strategies and businesses that involve risks and uncertainties. Forward–looking information includes statements concerning, among other things, statements with respect to the form, timing, ability to consummate or successful outcome of any strategic transactions pertaining to the Company's non-core assets, including the ongoing divestment of our Ryplazim® (Plasminogen) related business or assets; the utilization of proceeds from any such transaction; the potential of our product candidates and development of R&D programs and the timing of initiation or nature of pre-clinical and clinical trials.

    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 closing of the share purchase agreement for the plasma-derived therapeutics' business; 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 business operations, clinical development, regulatory activities and financial and other corporate impacts; the availability of funds and resources to pursue R&D projects, manufacturing operations or commercialization activities; the successful and timely initiation or completion of clinical trials; the ability of Liminal BioSciences 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; 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 Commissions, including in the Annual Report on Form 20-F for the year ended December 31, 2020 and future filings and reports by the Company, 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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    • Receipt of FDA Approval for Ryplazim® (plasminogen, human-tvmh)
    • Receipt of a Rare Pediatric Disease Priority Review Voucher
    • Signature of Agreement to Divest Plasma-Derived Therapeutics Business to Kedrion
    • Closing of the Sale of Plasma Collection Centers to Kedrion
    • Closing of the Sale of Plasma-Derived Therapeutics Manufacturing Facility to Kedrion
    • Signature of Agreement to Sell Rare Pediatric Disease Priority Review Voucher for US$105M

    LAVAL, QC and CAMBRIDGE, England, Aug. 16, 2021 /PRNewswire/ - Liminal BioSciences Inc. (NASDAQ:LMNL) ("Liminal BioSciences" or the "Company"), a clinical-stage biopharmaceutical company, today reported its financial results for the second quarter ended June 30, 2021.

    Liminal BioSciences will host a conference…

    • Receipt of FDA Approval for Ryplazim® (plasminogen, human-tvmh)
    • Receipt of a Rare Pediatric Disease Priority Review Voucher
    • Signature of Agreement to Divest Plasma-Derived Therapeutics Business to Kedrion
    • Closing of the Sale of Plasma Collection Centers to Kedrion
    • Closing of the Sale of Plasma-Derived Therapeutics Manufacturing Facility to Kedrion
    • Signature of Agreement to Sell Rare Pediatric Disease Priority Review Voucher for US$105M

    LAVAL, QC and CAMBRIDGE, England, Aug. 16, 2021 /PRNewswire/ - Liminal BioSciences Inc. (NASDAQ:LMNL) ("Liminal BioSciences" or the "Company"), a clinical-stage biopharmaceutical company, today reported its financial results for the second quarter ended June 30, 2021.

    Liminal BioSciences will host a conference call at 8:30 am (ET) on August 17, 2021. The telephone numbers to access the conference call are 1-888-390-0605 and 416-764-8609. An audio replay of the call will be available as of August 17, 2021 at 11:30 am (ET). The numbers to access the audio replay are 416-764-8677 and 1-888-390-0541 using the following password (882616). A live audio webcast of the conference call will be available by clicking here.

    "2021 has proven to be a transformational year thus far for Liminal with our first FDA approval and the continued implementation of our business strategy through the divestment of our plasma-derived therapeutics business and the recent closing of the sale of Prometic Bioproduction Inc., our plasma-derived therapeutics manufacturing business," stated Bruce Pritchard, Chief Executive Officer of Liminal BioSciences. "We anticipate building on this momentum with the resources from our recent transactions and the anticipated proceeds from the sale of our PRV, and we plan to update the market regarding our small molecules R&D strategy in the coming months following the review of the complete data from the ongoing fezagepras phase 1 multi-ascending dose clinical trial."

    For a more complete description of the Prometic Bioproduction Inc. ("PBP") divestment, please see the Company's Current Report on Form 6-K filed on July 9, 2021, with the U.S. Securities and Exchange Commission and the press release filed with SEDAR on July 9, 2021.

    Key Corporate and R&D Priorities

    Liminal BioSciences continues to take precautionary measures in response to the ongoing COVID-19 pandemic to protect the health of its employees and their families, patients and local communities. The Company has had only limited disruptions to its business operations related to the COVID-19 pandemic and provides the following updates:

    • Upon closing of sale of the Rare Pediatric Disease Priority Review Voucher ("PRV") for US$105 million, Liminal will be entitled to receive an amount equal to 70% of the net proceeds, which would be payable to Liminal by its subsidiary Prometic Biotherapeutics Inc. ("PBT") prior to closing the divestment of its remaining plasma-derived therapeutics business operated through PBT to Kedrion S.p.A. ("Kedrion").
    • Pending full analysis of the complete PK data set from the phase 1 multi-ascending dose ("MAD") clinical trial, we intend to determine the choice of other potential indication(s) for further development of fezagepras. No dose-limiting adverse events or other potential safety signals have been observed in the phase 1 MAD clinical trial to date.
    • Pending the outcome of our pre-clinical research, and successful nomination of a pre-clinical drug candidate, we plan to initiate a pre-clinical Investigational New Drug ("IND") enabling program to support a first-in-human Phase 1 single-ascending dose clinical trial of our GPR84 antagonist drug candidate to be selected in healthy volunteers for safety and tolerability.
    • Pending the outcome of our pre-clinical research, and successful nomination of a pre-clinical drug candidate, we plan to initiate a pre-clinical IND enabling program to support a first-in-human Phase 1 single-ascending dose clinical trial of our OXER1 drug candidate to be selected in healthy volunteers for safety and tolerability.

    Select Second Quarter 2021 Financial Results:

    The Company has presented the current and comparative periods results of operations of the Ryplazim® (plasminogen, human-tvmh) or Ryplazim® business and the plasma collection activities as discontinued operations as a result of the sale of the plasma collection centers in May 2021 and the Company's announcement in June of the signing of a share purchase agreement to sell the Ryplazim® related business. All figures presented in this section are in Canadian dollars unless otherwise specified.

    • Cash Position: Cash and cash equivalents at June 30, 2021 were $29.6 million. The Company's working capital, i.e., the current assets net of current liabilities, at June 30, 2021, amounted to $38.3 million.
    • Research and development expenses from continuing operations were $4.0 million for the second quarter of 2021 compared to $4.0 million for the second quarter of 2020. The increased cost associated with the ongoing Phase 1 MAD study for fezagepras that started in Dec 2020 was offset by a decrease in share-based payment expenses and payroll related expenses.
    • Administration expenses from continuing operations were $8.6 million for the second quarter of 2021 compared to $8.5 million for the second quarter of 2020.
    • Finance costs were $1.7 million for the second quarter of 2021 compared to $0.3 million for the second quarter of 2020, as a result of the long-term debt issuances in the third quarter of 2020.
    • Net loss from continuing operations, net of taxes was $12.6 million for the second quarter of 2021 compared to $13.2 million for the second quarter of 2020.
    • Gain on Sale of Subsidiaries was $10.7 million for the second quarter of 2021 compared to nil in 2020, as a result of the sale of the plasma collection centers in May 2021 and the proceeds received to date related to the sale of the Ryplazim® business.
    • Loss from discontinued operations were $30.2 million for the second quarter of 2021 compared to $14.7 million in 2020 the increase mainly due to the recording of a provision for an onerous contract of $21.9 million as a result of the divestiture of the plasma-derived therapeutic segment. This was partially offset by lower operating expenses, particularly research and development expenses following the closing of our Rockville, MD facility at the end of 2020.
    • Net loss was $32.1 million for the second quarter of 2021 compared to $27.8 million for the second quarter of 2020.

    About Liminal BioSciences Inc.

    Liminal BioSciences is a biopharmaceutical company focused on the discovery and development of novel, small molecule drug candidates for the treatment of patients suffering from respiratory fibrotic diseases and other fibrotic or inflammatory diseases that have a high unmet medical need.  The Company's lead small molecule product candidate, fezagepras (PBI-4050), is in a Phase 1 clinical trial in in the United Kingdom to evaluate multiple-ascending doses in normal healthy volunteers, at daily dose exposures higher than those evaluated in our previously completed Phase 2 clinical trials. The Company expects that a full analysis of the complete PK data set from the phase 1 multi-ascending dose clinical trial will help determine the choice of other potential indications for further development of fezagepras. In addition, the Company is also currently developing a selective GPR84 antagonist candidate and an oral, selective OXER1 antagonist candidate. Our GPR84 and OXER1 antagonist programs are currently at the pre-clinical stage.

    Liminal BioSciences has active business operations in Canada and the United Kingdom.

    Forward-Looking Statement

    This press release contains forward-looking statements about Liminal BioSciences' objectives, strategies and businesses that involve risks and uncertainties. Forward-looking information includes statements concerning, among other things, statements with respect to the form, timing, ability to consummate or successful outcome of any strategic transactions pertaining to the Company's non-core assets, including the ongoing divestment of our Ryplazim® (Plasminogen) related business or assets; the sale of the PRV or receipt of proceeds from such sale; the utilization of proceeds from any such transaction; the potential of our product candidates and development of R&D programs and the timing of initiation or nature of pre-clinical and clinical trials.

    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 closing of the share purchase agreement for the plasma-derived therapeutics' business; the closing of the asset purchase agreement relating to the PRV; Company's ability to develop, manufacture, and successfully commercialize product candidates, if ever; the impact of the COVID-19 pandemic on the Company's business operations, clinical development, regulatory activities and financial and other corporate impacts; the availability of funds and resources to pursue R&D projects, manufacturing operations or commercialization activities; the successful and timely initiation or completion of clinical trials; the ability of Liminal BioSciences 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; 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 Commissions, including in the Annual Report on Form 20-F for the year ended December 31, 2020 and future filings and reports by the Company, 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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  3. LAVAL, QC and CAMBRIDGE, England , Aug. 9, 2021 /PRNewswire/ - Liminal BioSciences Inc. (NASDAQ:LMNL) ("Liminal BioSciences" or the "Company"), announced today that, its subsidiary Prometic Biotherapeutics Inc. ("PBT") has entered into a definitive agreement to sell its Rare Pediatric Disease Priority Review Voucher ("PRV") for USD105M.

    The PRV was granted by the U.S. Food and Drug Administration ("FDA") with the approval of Ryplazim® (plasminogen, human-tvmh) ("Ryplazim®"), for treatment of patients with plasminogen deficiency type 1 (hypoplasminogenia).

    Pursuant to the terms of the agreement, PBT will receive an upfront payment of USD105M upon closing of the transaction. The closing is subject to customary closing conditions, including expiration…

    LAVAL, QC and CAMBRIDGE, England , Aug. 9, 2021 /PRNewswire/ - Liminal BioSciences Inc. (NASDAQ:LMNL) ("Liminal BioSciences" or the "Company"), announced today that, its subsidiary Prometic Biotherapeutics Inc. ("PBT") has entered into a definitive agreement to sell its Rare Pediatric Disease Priority Review Voucher ("PRV") for USD105M.

    The PRV was granted by the U.S. Food and Drug Administration ("FDA") with the approval of Ryplazim® (plasminogen, human-tvmh) ("Ryplazim®"), for treatment of patients with plasminogen deficiency type 1 (hypoplasminogenia).

    Pursuant to the terms of the agreement, PBT will receive an upfront payment of USD105M upon closing of the transaction. The closing is subject to customary closing conditions, including expiration of applicable waiting period under U.S. antitrust clearance requirements. Under the terms of the previously announced Share Purchase Agreement entered into with Kedrion S.p.A ("Kedrion") dated June 22, 2021 (the "SPA"); Liminal Biosciences is entitled to retain an amount equal to 70% of the net sales proceeds of the sale of the PRV. Concurrent with the signature of the definitive agreement for the sale of the PRV, the Company entered into a guaranty agreement to guaranty the performance of PBT's obligations under the agreement up to the closing of the SPA.

    "We are pleased to announce the sale of the PRV, which will provide an important source of non-dilutive capital to advance the continued development of our small molecule pipeline," said Bruce Pritchard, CEO of Liminal BioSciences. "This transaction is also another key milestone in completing the divestiture of our remaining plasma-derived therapeutics business to Kedrion."

    Mr. Pritchard added, "Our priorities now are to move to a full analysis of the complete PK data set from the phase 1 multi-ascending dose clinical trial for fezagepras, which will help determine the choice of any other potential indications for further development with that compound, as well as continuing with the development of our GPR84 and OXER1 programs. We look forward to providing a more comprehensive update on these programs in due course."

    Jefferies LLC acted as exclusive financial advisor to Liminal BioSciences Inc. on this transaction.

    Warnings and Precautions

    • Bleeding: RYPLAZIM administration may lead to bleeding at lesion sites or worsen active bleeding. Discontinue RYPLAZIM if serious bleeding occurs. Monitor patients during and for 4 hours after infusion when administering RYPLAZIM to patients with bleeding diatheses and patients taking anticoagulants, antiplatelet drugs, and other agents which may interfere with normal coagulation.
    • Tissue Sloughing: Respiratory distress due to tissue sloughing may occur in patients with mucosal lesions in the tracheobronchial tree following RYPLAZIM administration. Please monitor appropriately.
    • Transmission of Infectious Agents: RYPLAZIM is made from human blood and therefore carries a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and theoretically, the Creutzfeldt-Jakob Disease (CJD) agent.
    • Hypersensitivity Reactions: Hypersensitivity reactions, including anaphylaxis, may occur with RYPLAZIM. If symptoms occur, discontinue RYPLAZIM and administer appropriate treatment.
    • Neutralizing Antibodies: Neutralizing antibodies (inhibitors) may develop, although were not observed in clinical trials. If clinical efficacy is not maintained (e.g., development of new or recurrent lesions), then determine plasminogen activity levels in plasma.
    • Laboratory Abnormalities: Patients receiving RYPLAZIM may have elevated blood levels of D-dimer. D-Dimer levels will lack interpretability in patients being screened for venous thromboembolism (VTE).

     Adverse Reactions

    • The most frequent (incidence ≥ 10%) adverse reactions in clinical trials were abdominal pain, bloating, nausea, fatigue, extremity pain, hemorrhage, constipation, dry mouth, headache, dizziness, arthralgia, and back pain.

    Patient Counseling Information

    • Advise patients and/or caregiver to read the FDA-approved patient labeling
    • Counsel patients and/or caregiver to discontinue RYPLAZIM and immediately contact their physicians if signs or symptoms of a possible hypersensitivity reaction occur, such as hives, generalized urticaria, angioedema, chest tightness, wheezing, tachycardia, and hypotension
    • Inform patients that bleeding from active mucosal disease-related lesions and worsening of active bleeding not related to those lesions during RYPLAZIM therapy may occur. Depending on the lesion sites, this may manifest as gastrointestinal bleeding, hemoptysis, epistaxis, vaginal bleeding, or hematuria. Prior to initiation of treatment with RYPLAZIM, lesions or wounds suspected as the source of recent bleeding events should be confirmed to have healed. RYPLAZIM may prolong or worsen bleeding in patients with bleeding diatheses and/or taking anticoagulants or antiplatelet drugs. If a patient develops serious bleeding, seek emergency care and discontinue RYPLAZIM immediately.
    • Inform patients that tissue sloughing at mucosal sites may occur at initiation of RYPLAZIM therapy as lesions resolve. Patients with respiratory lesion are at risk for respiratory compromise and initial treatment with RYPLAZIM should be performed in a clinical setting with close monitoring. Patients with lesions in gastrointestinal and genitourinary systems may experience tissue sloughing that may cause pain, mucosal bleeding, or passage of tissue referable to those organ systems. Patients should report persistent abdominal, flank or pelvic pain to their physicians if not resolved.
    • Inform patients and/or caregiver that RYPLAZIM is made from human plasma and may contain infectious agents that can cause disease (eg, viruses, the variant Creutzfeldt-Jakob disease [vCJD] agent and, theoretically the CJD agent). Explain that the risk that RYPLAZIM may transmit an infectious agent has been reduced by screening the plasma donors, by testing donated plasma for certain virus infections, and by inactivating or removing certain viruses during manufacturing. Counsel patients and/or caregiver to report any symptoms that concern them.
    • Advise patients and/or caregivers that antibodies may develop during treatment that make RYPLAZIM less effective.
    • Advise female patients who are pregnant or may become pregnant that the potential effects of RYPLAZIM on pregnancy and breastfeeding are unknown. They should notify their physicians if they become or intend to become pregnant, or if they plan to breastfeed.
    • Self-administration: ensure patient/caregiver has received detailed instructions and training and has shown the ability to safely and independently administer RYPLAZIM.

    Contact Liminal BioSciences at +1(800) 735-4086 and or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    About the Rare Pediatric Disease Priority Review Voucher Program

    The program is intended to encourage development of new drug and biological products for prevention and treatment of certain rare pediatric diseases. A PRV may be issued to the sponsor of a rare pediatric disease product application and would entitle the holder to priority review of a single New Drug Application or Biologics License Application, which reduces the target review time and could lead to an expedited approval. The sponsor receives the PRV upon approval of the rare pediatric disease product application and it can be sold without limitation, subject to applicable FDA requirements for filing and use.

    About Liminal BioSciences Inc.

    Liminal BioSciences is a biopharmaceutical company focused on discovering, developing and commercializing novel treatments for patients suffering from diseases of unmet medical need, primarily related to fibrosis, including respiratory, liver and kidney diseases. In December 2020, Liminal BioSciences' lead small molecule product candidate, fezagepras (PBI-4050), entered a Phase 1 clinical trial in in the UK to evaluate multiple-ascending doses in normal healthy volunteers, at daily dose exposures higher than those evaluated in our previously completed Phase 2 clinical trials. The Company expects that a full analysis of the complete PK data set from the phase 1 multi-ascending dose clinical trial will help determine the choice of any other potential indication(s) for further development of fezagepras. No dose-limiting adverse events or other potential safety signals have been observed in the Phase 1 multiple-ascending dose clinical trial to date.

    Liminal BioSciences has active business operations in Canada and the United Kingdom.

    Forward Looking Statements

    This press release contains forward-looking statements about Liminal BioSciences' objectives, strategies and businesses that involve risks and uncertainties. Forward–looking information includes statements concerning, among other things, statements with respect to the closing of the sale of the equity interests of PBT; the closing of the asset sale for the sale of the PRV or receipt of proceeds from such sales; the utilization of proceeds from any such transaction; the potential of our product candidates and development of R&D programs and the timing of initiation or nature of preclinical and clinical trials.

    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 closing of the sale of the equity interests of PBT; the closing of the asset sale for the sale of the PRV; 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 business operations, clinical development, regulatory activities and financial and other corporate impacts; the availability of funds and resources to pursue R&D projects, manufacturing operations or commercialization activities; the successful and timely completion of clinical trials; the ability of Liminal BioSciences 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; 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 the Company makes with the U.S. Securities and Exchange Commission and Canadian Securities Commissions filings and reports filings and reports, including in the Annual Report on Form 20-F for the year ended December 31, 2020 and future filings and reports by the Company, from time to time. Such risks may be amplified by the COVID-19 pandemic and its potential impact on Liminal BioSciences' business and the global economy. As a result, we cannot guarantee that any 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.

    Cision View original content:https://www.prnewswire.com/news-releases/liminal-biosciences-announces-sale-of-priority-review-voucher-for-usd105m-301350945.html

    SOURCE Liminal BioSciences Inc.

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