1. Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (the "Company") today announced that members of the senior management team will present at the following upcoming virtual investor conferences:

    • Oppenheimer Fall Healthcare Life Sciences & MedTech Summit Monday, September 20, 2021 at 2:55 pm ET. (access here)
    • Cantor Global Healthcare Conference on September 30, 2021 at 12:40 pm ET. (access here)

    In order to participate in the audio webcasts, interested parties can also register and access presentations under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcasts will be available on Aurinia's website.

    ABOUT AURINIA

    Aurinia is a fully integrated biopharmaceutical company…

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (the "Company") today announced that members of the senior management team will present at the following upcoming virtual investor conferences:

    • Oppenheimer Fall Healthcare Life Sciences & MedTech Summit Monday, September 20, 2021 at 2:55 pm ET. (access here)
    • Cantor Global Healthcare Conference on September 30, 2021 at 12:40 pm ET. (access here)

    In order to participate in the audio webcasts, interested parties can also register and access presentations under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcasts will be available on Aurinia's website.

    ABOUT AURINIA

    Aurinia is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The Company recently introduced the first FDA-approved oral therapy indicated for the treatment of adult patients with active lupus nephritis (LN). Aurinia's head office is in Victoria, British Columbia; its U.S. commercial hub is in Rockville, Maryland; and the Company focuses development efforts globally.

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  2. Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (the "Company") today announced that members of the senior management team will participate in the H.C. Wainwright & Co. 23rd Annual Global Investment Conference, September 13-15, 2021. The Aurinia presentation will be available on-demand beginning September 13, 2021 at 3 pm ET.

    The audio webcast is available here. Interested parties can also register and access the presentation under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will be available on Aurinia's website.

    ABOUT AURINIA

    Aurinia is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations that are…

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (the "Company") today announced that members of the senior management team will participate in the H.C. Wainwright & Co. 23rd Annual Global Investment Conference, September 13-15, 2021. The Aurinia presentation will be available on-demand beginning September 13, 2021 at 3 pm ET.

    The audio webcast is available here. Interested parties can also register and access the presentation under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will be available on Aurinia's website.

    ABOUT AURINIA

    Aurinia is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The Company recently introduced the first FDA-approved oral therapy indicated for the treatment of adult patients with active lupus nephritis (LN). Aurinia's head office is in Victoria, British Columbia; its U.S. commercial hub is in Rockville, Maryland; and the Company focuses development efforts globally.

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  3. - Assets expand immunology portfolio to include B-cell therapy (BAFF/APRIL) and macrophage modulation -

    - IND-enabling studies are ongoing and will support the transition of these assets to clinical development in 2022/2023 -

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (Aurinia or the Company) today announced the addition of two novel assets that will expand the Company's rare autoimmune and kidney-related disease pipeline.

    "Over the past year, in anticipation of building out and diversifying our development pipeline, we have brought on additional large and small molecule expertise that uniquely aligns with Aurinia's focus on immunology and nephrology," said Peter Greenleaf, President and Chief Executive Officer of Aurinia. "These transactions…

    - Assets expand immunology portfolio to include B-cell therapy (BAFF/APRIL) and macrophage modulation -

    - IND-enabling studies are ongoing and will support the transition of these assets to clinical development in 2022/2023 -

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (Aurinia or the Company) today announced the addition of two novel assets that will expand the Company's rare autoimmune and kidney-related disease pipeline.

    "Over the past year, in anticipation of building out and diversifying our development pipeline, we have brought on additional large and small molecule expertise that uniquely aligns with Aurinia's focus on immunology and nephrology," said Peter Greenleaf, President and Chief Executive Officer of Aurinia. "These transactions are transformational for Aurinia as they allow us to leverage our existing R&D capabilities and commercial experience to support a balanced pipeline and advance innovative therapeutic solutions to help people living with rare autoimmune diseases."

    AUR200: Recombinant Fc Protein Targeting BAFF/APRIL

    The first program, AUR200, was acquired by way of Aurinia purchasing all of the common stock of Thunderbolt Pharma, Inc. (Thunderbolt), a private company. AUR200 is a recombinant Fc fusion protein designed to specifically block B-cell Activating Factor, known as BAFF, and A Proliferation-Inducing Ligand, known as APRIL. BAFF and APRIL promote B cell survival and differentiation and have been shown to play a prominent role in the pathogenesis of certain autoimmune and nephrology conditions.

    For the acquisition, Aurinia made an aggregate upfront payment of $750,000 USD to the shareholders of Thunderbolt and will be responsible for future regulatory milestones upon investigational new drug (IND) acceptance by the United States' Food and Drug Administration (FDA) or any equivalent authority. Additionally, Thunderbolt shareholders will receive low single digit royalties on any future net sales. AUR200 is currently undergoing pre-clinical development with projected submission of an IND to the FDA by the end of 2022.

    "BAFF/APRIL inhibition has been extensively studied and established as an important approach to managing immunologic response," said Neil Solomons, MD, Chief Medical Officer, Aurinia. "We are encouraged by AUR200's unique profile and best-in-class potential and look forward to sharing further data and updates on this exciting program."

    AUR300: M2 macrophage modulation via CD206 binding

    The second program, AUR300, was secured through a global licensing and research agreement with Riptide Bioscience Inc. (Riptide), a private company. AUR300 is a novel peptide therapeutic that modulates M2 macrophages (a type of white blood cells) via the macrophage mannose receptor CD206. Dysregulation of M2 macrophages drives fibrosis. AUR300 acts to reduce M2 dysregulation and decrease inflammatory cytokines, and therefore may have significant clinical applications for autoimmune and fibrotic diseases.

    Riptide has longstanding expertise in interpreting the etiology of fibrosis, including the discovery of lysyl oxidase and procollagen. As part of the agreement, Aurinia paid Riptide an upfront fee of $6 million USD. Additional milestone payments are due upon certain development, clinical and regulatory milestones, and royalties will be payable upon commercialization. It is anticipated that clinical development for AUR300 will commence during the first half of 2023.

    "Both of these programs are rooted in strong science and at the leading edge of approaches for the treatment of autoimmune, fibrotic, and kidney diseases," said Rob Huizinga, PhD, RN, CNeph(C), Executive Vice President of Research, Aurinia. "Significant research has been done to date in both BAFF/APRIL inhibition and macrophage modulation and we are confident both of these approaches offer high potential across multiple autoimmune diseases as we advance them into the clinic."

    About Aurinia

    Aurinia is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The Company recently introduced the first FDA-approved oral therapy indicated for the treatment of adult patients with active lupus nephritis (LN). Aurinia's head office is in Victoria, British Columbia; its U.S. commercial hub is in Rockville, Maryland; and the Company focuses development efforts globally.

    Forward-Looking Statements

    Certain statements made in this press release may constitute forward-looking information within the meaning of applicable Canadian securities law and forward-looking statements within the meaning of applicable United States securities law. These forward-looking statements or information include but are not limited to statements or information with respect to: the timing of transitioning AUR200 and AUR300 into clinical development; that the acquisitions of AUR200 and AUR300 are transformational for Aurinia; Aurinia's belief that the mechanism of action of the AUR300 peptide may have significant clinical applications for autoimmune or fibrotic diseases; the timing for filing an IND for AUR200 and AUR300; Aurinia's belief that AUR200 has the potential to be a unique and best in class BAFF/APRIL inhibitor; Aurinia's belief that AUR200 and AUR300 are at the leading edge of approaches for the treatment of autoimmune, fibrotic and kidney diseases; and Aurinia's belief that macrophage modulation and BAFF/APRIL inhibition offer high potential across multiple autoimmune diseases. It is possible that such results or conclusions may change. Words such as "anticipate", "will", "believe", "estimate", "expect", "intend", "target", "plan", "goals", "objectives", "may" and other similar words and expressions, identify forward-looking statements. We have made numerous assumptions about the forward-looking statements and information contained herein, including among other things, assumptions about: assumptions relating to the burn rate of Aurinia's cash for operations; and that Aurinia's third party service providers will comply with their contractual obligations. Even though the management of Aurinia believes that the assumptions made, and the expectations represented by such statements or information are reasonable, there can be no assurance that the forward-looking information will prove to be accurate.

    Forward-looking information by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance, or achievements of Aurinia to be materially different from any future results, performance or achievements expressed or implied by such forward-looking information. Should one or more of these risks and uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in forward-looking statements or information. Such risks, uncertainties and other factors include, among others, the following: Aurinia's actual future financial and operational results may differ from its expectations; Aurinia may have to pay unanticipated expenses; unknown impact and difficulties imposed by the COVID-19 pandemic on Aurinia's business operations including nonclinical, clinical, regulatory and commercial activities; the future prospects for AUR200 and AUR300 may not be as Aurinia has anticipated, or Aurinia may not be able to fully capitalize on the opportunities presented by AUR200 and AUR300; Aurinia's third party service providers may not, or may not be able to, comply with their obligations under their agreements with Aurinia; and Aurinia's assets or business activities may be subject to disputes that may result in litigation or other legal claims. Although Aurinia has attempted to identify factors that would cause actual actions, events, or results to differ materially from those described in forward-looking statements and information, there may be other factors that cause actual results, performances, achievements, or events to not be as anticipated, estimated or intended. Also, many of the factors are beyond Aurinia's control. There can be no assurance that forward-looking statements or information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, you should not place undue reliance on forward-looking statements or information.

    All forward-looking information contained in this press release is qualified by this cautionary statement. Additional information related to Aurinia, including a detailed list of the risks and uncertainties affecting Aurinia and its business, can be found in Aurinia's most recent Annual Report on Form 10-K available by accessing the Canadian Securities Administrators' System for Electronic Document Analysis and Retrieval (SEDAR) website at www.sedar.com or the U.S. Securities and Exchange Commission's Electronic Document Gathering and Retrieval System (EDGAR) website at www.sec.gov/edgar, or on Aurinia's website at www.auriniapharma.com.

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  4. Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (the "Company") today announced that members of the executive management team will participate in a fireside chat during the Virtual BTIG Annual Biotech Conference on Tuesday, August 10, 2021 at 2:50 p.m. ET.

    In order to participate in the audio webcast, interested parties can access the live webcast under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will be available on Aurinia's website.

    ABOUT AURINIA

    Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The…

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (the "Company") today announced that members of the executive management team will participate in a fireside chat during the Virtual BTIG Annual Biotech Conference on Tuesday, August 10, 2021 at 2:50 p.m. ET.

    In order to participate in the audio webcast, interested parties can access the live webcast under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will be available on Aurinia's website.

    ABOUT AURINIA

    Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The Company has introduced LUPKYNIS™ (voclosporin), the first FDA-approved oral therapy dedicated for the treatment of adult patients with active lupus nephritis (LN). The Company's head office is in Victoria, British Columbia, its U.S. commercial hub is in Rockville, Maryland, and the Company focuses its development efforts globally.

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  5. – $6.6 million in net revenue for the second quarter 2021 (624% increase from first quarter 2021) –
    – 415 patient start forms (PSFs) received for LUPKYNIS™ during the second quarter (over a 60% increase from the first quarter 2021) and over 800 PSFs received year-to-date –
    – Continued ex-U.S. execution highlighted by the submission of a voclosporin MAA to the EMA by Otsuka –
    – Cash and cash equivalents, and investments of $323.7 million at June 30, 2021 –
    – Conference call to be hosted today at 4:30 p.m. EDT –

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) ("Aurinia" or the "Company") today issued its financial results for the second quarter ended June 30, 2021. Amounts, unless specified otherwise, are expressed in U.S. dollars.

    "Aurinia continues…

    – $6.6 million in net revenue for the second quarter 2021 (624% increase from first quarter 2021) –

    – 415 patient start forms (PSFs) received for LUPKYNIS™ during the second quarter (over a 60% increase from the first quarter 2021) and over 800 PSFs received year-to-date –

    – Continued ex-U.S. execution highlighted by the submission of a voclosporin MAA to the EMA by Otsuka –

    – Cash and cash equivalents, and investments of $323.7 million at June 30, 2021 –

    – Conference call to be hosted today at 4:30 p.m. EDT –

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) ("Aurinia" or the "Company") today issued its financial results for the second quarter ended June 30, 2021. Amounts, unless specified otherwise, are expressed in U.S. dollars.

    "Aurinia continues to make progress toward transforming the treatment of lupus nephritis (LN) by improving access to treatment and providing disease education and care for the long underserved LN patient community," said Peter Greenleaf, President and Chief Executive Officer of Aurinia. "Our second quarter results demonstrate our momentum as COVID-related restrictions are loosened in parts of the United States with a significant increase in both revenue and patient start forms. We are confident that with this year-to-date performance and a strong balance sheet, that we are well-poised for growth as we continue our work to expand the treatment of LN and seek new opportunities that could address the needs of patients with serious autoimmune disorders."

    Mr. Greenleaf further stated, "As we continue to expand patient access to LUPKYNIS across the United States, we anticipate that annual net revenue for LUPKYNIS will be in the range of $40 to $50 million for 2021, setting Aurinia up for a very strong 2022 as we recognize the benefit of patients continuing on therapy and hopefully achieving reductions in their proteinuria."

    Recent Highlights

    Second Quarter 2021 U.S. Commercial Activities

    • 415 PSFs during the second quarter with over 800 PSFs received year-to-date;
    • As of June 30, 2021, a total of 45 LUPKYNIS-specific policies had been published by insurers representing approximately 110 million covered lives in the U.S.; and
    • Converted over 50% of PSFs to patients on therapy by the end of the second quarter.

    Recent Operational Developments

    • On May 10, 2021, The Lancet, an international, peer-reviewed medical journal, published the results of the Company's Phase 3 AURORA-1 study evaluating LUPKYNIS (voclosporin) in adults with LN.
    • On May 20, 2021, the Company announced that the interim analysis of the AURORA-2 continuation study showed that subjects in the LUPKYNIS treatment arm sustained meaningful reductions in proteinuria, with no change in mean estimated glomerular filtration rate (eGFR) at 104 weeks of treatment.
    • Effective June 14, 2021, the Company appointed Dr. Brinda Balakrishnan, M.D., Ph.D., to the Company's Board of Directors. Dr. Balakrishnan is Group Vice President, Corporate and Business Development of BioMarin Pharmaceutical Inc.
    • On June 25, 2021, Aurinia's licensing partner, Otsuka Pharmaceutical Co., Ltd., filed an initial marketing authorization application (MAA) with the European Medicines Agency (EMA) seeking approval for the use of voclosporin for the treatment of adult patients with active LN in the European Union, as well as Norway, Iceland and Liechtenstein. Upon approval the Company would be eligible for up to an additional $30 million in approval related milestones, low double-digit royalties on sales, and additional revenues for the supply of product to Otsuka under a cost-plus arrangement.

    Upcoming Milestones

    • Aurinia anticipates reporting top-line results from the ongoing AURORA-2 two-year continuation study of voclosporin for the treatment of LN by the end of 2021.

    Financial Liquidity at June 30, 2021

    As of June 30, 2021, Aurinia had cash and cash equivalents and investments of $323.7 million compared to $422.7 million at December 31, 2020. The decrease was primarily related to the commercial infrastructure spend to support the launch of LUPKYNIS, payments for inventory and an upfront payment made as part of a collaborative agreement with Lonza to build a dedicated manufacturing capability (or monoplant).

    Net cash used in operating activities was $91.5 million for the six months ended June 30, 2021 compared to $44.6 million for the six months ended June 30, 2020. The increase was primarily due to the commercial infrastructure spend to support the launch of LUPKYNIS, payments for inventory and a one-time payment to a related party upon achievement of specific milestones. In the prior year, the Company was still in the development phase of LUPKYNIS and as a result, did not incur any material related selling expenses.

    The Company believes that it has sufficient financial resources to fund its current plans, which include funding commercial activities, including FDA related post approval commitments, manufacturing and packaging of commercial drug supply, conducting planned research and development (R&D) programs, and operating activities into at least 2023.

    Financial Results for the Quarter Ended June 30, 2021

    For the quarter ended June 30, 2021, Aurinia recorded a net loss of $47.0 million or $0.37 net loss per common share, as compared to a net loss of $26.5 million or $0.24 net loss per common share for the quarter ended June 30, 2020. For the six months ended June 30, 2021, Aurinia recorded a net loss of $97.4 million or $0.76 net loss per common share as compared to a net loss of $52.5 million or $0.47 net loss per common share.

    Total revenue was $6.6 million and $29 thousand for the quarters ended June 30, 2021 and June 30, 2020, respectively. Total revenue was $7.5 million and $59 thousand for the six months ended June 30, 2021 and June 30, 2020, respectively. The increase for both periods was primarily the result of the commercial sales of LUPKYNIS following FDA approval in January 2021.

    Cost of sales were $308 thousand and nil for the quarters ended June 30, 2021 and June 30, 2020, respectively. Cost of sales were $356 thousand and nil for the six months ended June 30, 2021 and June 30, 2020, respectively. The increase for both periods was primarily the result of commercial sales of LUPKYNIS. Gross margin for the three and six months ended June 30, 2021 was approximately 95%.

    Selling, general and administrative (SG&A) expenses were $43.8 million and $15.4 million for the quarters ended June 30, 2021 and June 30, 2020, respectively. For the six months ended June 30, 2021 and June 30, 2020, SG&A expenses were $83.1 million and $26.5 million, respectively. The increase for both periods was primarily due to the expansion of the commercial infrastructure, administrative functions and patient assistance programs to support the launch of LUPKYNIS. SG&A share-based compensation expense for the three and six months ended June 30, 2021 was $6.5 million and $13.2 million, respectively.

    R&D expenses were $10.1 million and $11.1 million for the quarters ended June 30, 2021 and June 30, 2020, respectively. For the six months ended June 30, 2021 and June 30, 2020, R&D expenses were $19.9 million and $24.9 million, respectively. The decrease for both periods was primarily due to lower contract research organization expenses and other third-party clinical trial expenses following the approval of LUPKYNIS, including a reduction in new drug application preparation costs, capitalization of supply costs following approval, and termination of the dry eye trial during the fourth quarter of 2020. R&D share-based compensation expense for the three and six months ended June 30, 2021 was $1.1 million and $2.2 million, respectively.

    This press release is intended to be read in conjunction with the Company's unaudited condensed consolidated financial statements and Management's Discussion and Analysis for the quarter ended June 30, 2021 in the Company's Quarterly Report on Form 10-Q, which is accessible on Aurinia's website at www.auriniapharma.com, on SEDAR at www.sedar.com or on EDGAR at www.sec.gov/edgar.

    Conference Call Details

    Aurinia will host a conference call and webcast to discuss the quarter ended June 30, 2021 financial results today, Thursday, August 5, 2021 at 4:30 p.m. EDT. The audio webcast can be accessed under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. In order to participate in the conference call, please dial +1-877-407-9170 (Toll-free U.S. & Canada). An audio webcast can be accessed under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will be available on Aurinia's website.

    About Lupus Nephritis

    LN is a serious progression of systemic lupus erythematosus (SLE), a chronic and complex autoimmune disease. About 200,000-300,000 people live with SLE in the U.S. and approximately one out of three of these individuals have already developed LN at the time of SLE diagnosis. If poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney, resulting in kidney failure. Black and Asian individuals with SLE are four times more likely to develop LN and individuals with Hispanic ancestry are approximately twice as likely to develop the disease when compared with Caucasian individuals. Black and Hispanic individuals with SLE also tend to develop LN earlier and have poorer outcomes when compared to Caucasian individuals.

    About Aurinia

    Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The Company has introduced LUPKYNIS (voclosporin), the first FDA-approved oral therapy dedicated for the treatment of adult patients with active LN. The Company's head office is in Victoria, British Columbia, its U.S. commercial hub is in Rockville, Maryland, and the Company focuses its development efforts globally.

    Forward-Looking Statements

    Certain statements made in this press release may constitute forward-looking information within the meaning of applicable Canadian securities law and forward-looking statements within the meaning of applicable United States securities law. These forward-looking statements or information include but are not limited to statements or information with respect to: Aurinia's estimates as to annual net revenue in the range of $40-$50 million in 2021; Aurinia's estimates as to the number of patients with SLE in the U.S. and the proportion of those persons who will develop LN; Aurinia being confident that it is well-poised for growth; Aurinia's belief that it has sufficient financial resources to fund its current plans until 2023; and the planned timing for reporting top-line results from the ongoing AURORA-2 continuation study. It is possible that such results or conclusions may change. Words such as "anticipate", "will", "believe", "estimate", "expect", "intend", "target", "plan", "goals", "objectives", "may" and other similar words and expressions, identify forward-looking statements. We have made numerous assumptions about the forward-looking statements and information contained herein, including among other things, assumptions about: the accuracy of reported data from third party studies and reports; the number, and timing of receipt, of PSFs and their rate of conversion into patients on therapy; that Aurinia's intellectual property rights are valid and do not infringe the intellectual property rights of third parties; Aurinia's assumptions relating to the capital required to fund operations into 2023; the assumption that Aurinia's current good relationships with its suppliers, service providers and other third parties will be maintained; assumptions relating to the burn rate of Aurinia's cash for operations; the relationship between COVID vaccinations and patient treatment; and that Aurinia's third party service providers will comply with their contractual obligations. Even though the management of Aurinia believes that the assumptions made, and the expectations represented by such statements or information are reasonable, there can be no assurance that the forward-looking information will prove to be accurate.

    Forward-looking information by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance, or achievements of Aurinia to be materially different from any future results, performance or achievements expressed or implied by such forward-looking information. Should one or more of these risks and uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in forward-looking statements or information. Such risks, uncertainties and other factors include, among others, the following: Aurinia's actual future financial and operational results may differ from its expectations; difficulties Aurinia may experience in completing the commercialization of voclosporin; the market for the LN business may not be as estimated; Aurinia may have to pay unanticipated expenses; Aurinia may not be able to obtain sufficient supply to meet commercial demand for voclosporin in a timely fashion; unknown impact and difficulties imposed by the COVID-19 pandemic on Aurinia's business operations including nonclinical, clinical, regulatory and commercial activities; the results from Aurinia's clinical studies and from third party studies and reports may not be accurate; Aurinia's third party service providers may not, or may not be able to, comply with their obligations under their agreements with Aurinia; and Aurinia's assets or business activities may be subject to disputes that may result in litigation or other legal claims. Although Aurinia has attempted to identify factors that would cause actual actions, events, or results to differ materially from those described in forward-looking statements and information, there may be other factors that cause actual results, performances, achievements, or events to not be as anticipated, estimated or intended. Also, many of the factors are beyond Aurinia's control. There can be no assurance that forward-looking statements or information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, you should not place undue reliance on forward-looking statements or information.

    All forward-looking information contained in this press release is qualified by this cautionary statement. Additional information related to Aurinia, including a detailed list of the risks and uncertainties affecting Aurinia and its business, can be found in Aurinia's most recent Annual Report on Form 10-K available by accessing the Canadian Securities Administrators' System for Electronic Document Analysis and Retrieval (SEDAR) website at www.sedar.com or the U.S. Securities and Exchange Commission's Electronic Document Gathering and Retrieval System (EDGAR) website at www.sec.gov/edgar, or on Aurinia's website at www.auriniapharma.com.

    AURINIA PHARMACEUTICALS INC. AND SUBSIDIARIES

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (in thousands)

     

     

    June 30,

    2021

     

    December 31,

    2020

     

     

    (unaudited)

     

     

    ASSETS

     

     

     

     

    Current assets

     

     

     

     

    Cash and cash equivalents

     

    $

    121,561

     

     

    $

    272,350

     

    Short-term investments

     

    197,176

     

     

    125,979

     

    Accounts receivable, net

     

    4,418

     

     

     

    Inventories, net

     

    17,376

     

     

    13,927

     

    Prepaid expenses and other current assets

     

    9,158

     

     

    7,171

     

    Total current assets

     

    349,689

     

     

    419,427

     

     

     

     

     

     

    Non-current assets

     

     

     

     

    Long-term investments

     

    5,004

     

     

    24,380

     

    Other non-current assets

     

    11,856

     

     

    247

     

    Property and equipment, net

     

    4,813

     

     

    4,786

     

    Acquired intellectual property and other intangible assets, net

     

    9,291

     

     

    9,332

     

    Right-of-use assets

     

    5,615

     

     

    5,489

     

    Total assets

     

    386,268

     

     

    463,661

     

     

     

     

     

     

    LIABILITIES

     

     

     

     

    Current liabilities

     

     

     

     

    Accounts payable and accrued liabilities

     

    25,831

     

     

    24,797

     

    Other current liabilities (of which $2,000 and $6,000, due to related party in 2021 and 2020, respectively)

     

    2,372

     

     

    6,412

     

    Operating lease liabilities

     

    1,112

     

     

    788

     

    Total current liabilities

     

    29,315

     

     

    31,997

     

     

     

     

     

     

    Non-current liabilities

     

     

     

     

    Other non-current liabilities

     

    16,872

     

     

    16,295

     

    Operating lease liabilities

     

    7,824

     

     

    7,619

     

    Total liabilities

     

    54,011

     

     

    55,911

     

    SHAREHOLDER'S EQUITY

     

     

     

     

    Common shares - no par value, unlimited shares authorized, 128,396 and 126,725 shares issued and outstanding as at June 30, 2021 and December 31, 2020, respectively

     

    954,572

     

     

    944,328

     

    Additional paid-in capital

     

    51,022

     

     

    39,383

     

    Accumulated other comprehensive loss

     

    (792

    )

     

    (805

    )

    Accumulated deficit

     

    (672,545

    )

     

    (575,156

    )

    Total shareholder's equity

     

    332,257

     

     

    407,750

     

    Total liabilities and shareholders' equity

     

    $

    386,268

     

     

    $

    463,661

     

    AURINIA PHARMACEUTICALS INC. AND SUBSIDIARIES

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (in thousands, except per share data)

     

     

    Three months ended

     

    Six months ended

     

     

    June 30,

     

    June 30,

     

     

    2021

     

    2020

     

    2021

     

    2020

     

     

    (unaudited)

     

    (unaudited)

    Revenue

     

     

     

     

     

     

     

     

    Product revenue, net

     

    $

    6,591

     

     

    $

     

     

    $

    7,475

     

     

    $

     

    License revenue

     

    29

     

     

    29

     

     

    59

     

     

    59

     

    Total revenue

     

    6,620

     

     

    29

     

     

    7,534

     

     

    59

     

    Operating expenses:

     

     

     

     

     

     

     

     

    Cost of sales

     

    308

     

     

     

     

    356

     

     

     

    Selling, general and administrative

     

    43,786

     

     

    15,449

     

     

    83,068

     

     

    26,502

     

    Research and development

     

    10,091

     

     

    11,076

     

     

    19,924

     

     

    24,911

     

    Amortization of intangible assets

     

    536

     

     

    300

     

     

    1,059

     

     

    586

     

    Other (income) expense, net

     

    (967

    )

     

    67

     

     

    804

     

     

    1,983

     

    Total cost and operating expenses

     

    53,754

     

     

    26,892

     

     

    105,211

     

     

    53,982

     

    Loss from operations

     

    (47,134

    )

     

    (26,863

    )

     

    (97,677

    )

     

    (53,923

    )

    Interest income

     

    142

     

     

    321

     

     

    314

     

     

    1,211

     

    Net loss before income taxes

     

    (46,992

    )

     

    (26,542

    )

     

    (97,363

    )

     

    (52,712

    )

    Income tax expense (benefit)

     

    18

     

     

    2

     

     

    26

     

     

    (236

    )

    Net loss

     

    $

    (47,010

    )

     

    $

    (26,544

    )

     

    $

    (97,389

    )

     

    $

    (52,476

    )

    Basic and diluted loss per share

     

    $

    (0.37

    )

     

    $

    (0.24

    )

     

    $

    (0.76

    )

     

    $

    (0.47

    )

    Weighted-average common shares outstanding used in computation of basic and diluted loss per share

     

    128,222

     

     

    112,576

     

     

    127,814

     

     

    112,392

     

     

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  6. Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) (the "Company") today announced that it will release its second quarter 2021 financial results on Thursday, August 5, 2021, after the markets close. Aurinia's management team will also host a conference call at 4:30 p.m. EDT to discuss the Company's financial results and to provide a general business update.

    The conference call and webcast is scheduled for August 5, 2021 at 4:30 p.m. ET. In order to participate in the conference call, please dial +1-877-407-9170 (Toll-free U.S. & Canada). An audio webcast can be accessed under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will be available on Aurinia's website…

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) (the "Company") today announced that it will release its second quarter 2021 financial results on Thursday, August 5, 2021, after the markets close. Aurinia's management team will also host a conference call at 4:30 p.m. EDT to discuss the Company's financial results and to provide a general business update.

    The conference call and webcast is scheduled for August 5, 2021 at 4:30 p.m. ET. In order to participate in the conference call, please dial +1-877-407-9170 (Toll-free U.S. & Canada). An audio webcast can be accessed under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will be available on Aurinia's website.

    ABOUT AURINIA

    Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The Company has introduced LUPKYNIS™ (voclosporin), the first FDA-approved oral therapy dedicated for the treatment of adult patients with active lupus nephritis (LN). The Company's head office is in Victoria, British Columbia, its U.S. commercial hub is in Rockville, Maryland, and the Company focuses its development efforts globally.

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  7. Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) (Aurinia or the Company), a commercial stage biopharmaceutical company advancing therapies for severe autoimmune diseases, announced today it will voluntarily delist the common shares of the Company from the Toronto Stock Exchange (TSX) effective as of the close of trading on July 30, 2021. The Company's common shares will no longer be traded on the TSX but will continue to trade on the Nasdaq Capital Market (Nasdaq) under the symbol AUPH.

    Trading on the Nasdaq accounted for approximately 94 percent of Aurinia's daily trading volume over the past 12 months. Therefore, the Company believes that the trading volume of its shares on the TSX no longer justifies the expense and administrative efforts…

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) (Aurinia or the Company), a commercial stage biopharmaceutical company advancing therapies for severe autoimmune diseases, announced today it will voluntarily delist the common shares of the Company from the Toronto Stock Exchange (TSX) effective as of the close of trading on July 30, 2021. The Company's common shares will no longer be traded on the TSX but will continue to trade on the Nasdaq Capital Market (Nasdaq) under the symbol AUPH.

    Trading on the Nasdaq accounted for approximately 94 percent of Aurinia's daily trading volume over the past 12 months. Therefore, the Company believes that the trading volume of its shares on the TSX no longer justifies the expense and administrative efforts associated with maintaining a dual listing. The Company is confident that the transition to a single listing will help deliver better value to its shareholders, employees and of course, the patient and HCP communities it serves. Pursuant to Sec. 720(b) of the TSX Company Manual, shareholder approval is not required as an acceptable alternative market exists for the listed securities.

    Most brokers in Canada, including discount and online brokers, have the ability to buy and sell securities listed on Nasdaq. Therefore, the Company's Nasdaq listing will continue to provide shareholders with the same accessibility to trade the Company's common shares. The value of investor shares or stock options is not related to or dependent on the TSX listing. Shareholders holding shares or options in Canadian brokerage accounts should contact their brokers to confirm how to trade the Company's shares on the Nasdaq.

    About Aurinia

    Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The Company's head office is in Victoria, British Columbia, its U.S. commercial hub is in Rockville, Maryland, and the Company focuses its development efforts globally.

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  8. Five patient organizations will receive funds to implement plans aimed at reducing health disparities, connecting people living with systemic lupus erythematosus (SLE) and lupus nephritis (LN) with needed health management resources

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) (the Company) today announced the recipients of five $50,000 grant awards to support implementation patient navigation programs targeted toward disadvantaged populations at most risk of developing SLE and LN. Each non-profit patient-focused organization will receive funds to support their proposed one-year pilot programs with the goal of helping people living with these conditions to navigate the complexities of diagnosis and disease management, support better…

    Five patient organizations will receive funds to implement plans aimed at reducing health disparities, connecting people living with systemic lupus erythematosus (SLE) and lupus nephritis (LN) with needed health management resources

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) (the Company) today announced the recipients of five $50,000 grant awards to support implementation patient navigation programs targeted toward disadvantaged populations at most risk of developing SLE and LN. Each non-profit patient-focused organization will receive funds to support their proposed one-year pilot programs with the goal of helping people living with these conditions to navigate the complexities of diagnosis and disease management, support better adherence to medical appointments and treatments, and provide customized resources and education.

    "The RFP process was competitive, and we were pleased to receive so many thoughtful and creative submissions for this first-ever Aurinia initiative," said Christine Lindsay, Vice President, Professional and Advocacy Relations. "The five recipients were awarded grants based on their demonstrated ability to collaborate with key lupus centers, rheumatologists, and nephrologists, their ability to measure program outcomes, and ultimately, provide individualized support to underserved populations."

    Navigation programs will be launched in the following cities:

    • Atlanta, Georgia

      Lupus Foundation of America Georgia Chapter in collaboration with the Grady Lupus Clinic
    • Brooklyn, New York

      The Health Science Center of Brooklyn Foundation in collaboration with SUNY Downstate Health Sciences University
    • Cleveland, Ohio

      Lupus Foundation of America Ohio Chapter in collaboration with the Ohio Department of Health
    • Indianapolis, Indiana

      Lupus Foundation of America Indiana Chapter in collaboration with Eskenazi

      Hospital, Lupus Clinic, and Indiana University Hospital
    • Philadelphia, Pennsylvania

      Lupus Foundation of America Tri-State Chapter in collaboration with Temple University Hospital Lupus Program

    "The need for a patient navigator program at our institution, and many like ours, is enormous. It has long been recognized that racial and ethnic characteristics influence outcome in patients with SLE. Black (African American and Afro-Caribbean) and Hispanic SLE patients have more severe disease than white patients, with higher mortality and a more rapid accrual of irreversible damage," says Ellen M. Ginzler MD, MPH, Vice Chair for Research, Department of Medicine Chief, Rheumatology Division, SUNY Downstate Health Science University. "We are pleased and honored to work with The Health Science Center of Brooklyn Foundations to implement a student-led navigator program and to work to reduce health disparities, stressing early diagnosis, and providing compassionate high quality care to immigrant, at-risk, and underserved individuals."

    "Twenty years ago, very few spoke of lupus. There was little awareness and understanding of the signs and symptoms and very little investment in research. We have made great progress, but we must do more as we have lost too many too early of all ages, and we cannot rest," states Sam Lim, MD, MPH, Professor of Medicine and Epidemiology, Emory University, Chief of Rheumatology – Grady Health System, and Director of the Grady Lupus Clinic. "We are eager to work with the Lupus Foundation of America, Georgia chapter, to implement a patient navigator program that will mitigate the barriers to health equity by improving patient adherence to treatment, provider-patient communication, patient mental and physical health, and, most importantly, outcomes."

    Aurinia funded patient navigator programs launch on July 1 and grant recipients will convene regularly to share lessons learned, best practices, and community needs that can be addressed through navigation services throughout the 1-year grant period.

    About systemic lupus erythematosus (SLE) and lupus nephritis (LN)

    LN is a serious manifestation of SLE, a chronic and complex autoimmune disease. Approximately one out of three of these individuals with SLE will develop LN. If poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney, resulting in kidney failure. Black and Asian individuals with SLE are four times more likely to develop LN and individuals of Hispanic ancestry are approximately twice as likely to develop the disease when compared with Caucasian individuals. Black and Hispanic individuals with SLE also tend to develop LN earlier and have poorer outcomes when compared to Caucasian individuals.

    About Aurinia

    Aurinia Pharmaceuticals, Inc. is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The Company's head office is in Victoria, British Columbia, its U.S. commercial hub is in Rockville, Maryland, and the Company focuses its development efforts globally.

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  9. Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) (the Company) announced today that the Company's licensing partner, Otsuka Pharmaceutical Europe Ltd. (OPEL), filed an initial Marketing Authorization Application (MAA) for voclosporin for the treatment of lupus nephritis (LN) to the European Medicines Agency (EMA). LN is a complication of the autoimmune disease systemic lupus erythematosus (SLE) that seriously impacts the kidneys. In January 2021, the U.S. Food and Drug Administration (FDA) approved voclosporin in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active LN and it is currently available in the U.S. under the brand name LUPKYNIS™.

    In December 2020, Aurinia entered into…

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) (the Company) announced today that the Company's licensing partner, Otsuka Pharmaceutical Europe Ltd. (OPEL), filed an initial Marketing Authorization Application (MAA) for voclosporin for the treatment of lupus nephritis (LN) to the European Medicines Agency (EMA). LN is a complication of the autoimmune disease systemic lupus erythematosus (SLE) that seriously impacts the kidneys. In January 2021, the U.S. Food and Drug Administration (FDA) approved voclosporin in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active LN and it is currently available in the U.S. under the brand name LUPKYNIS™.

    In December 2020, Aurinia entered into a collaboration and licensing agreement with OPEL for the development and commercialization of voclosporin for the treatment of LN in the European Union, Japan, the United Kingdom, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein, and Ukraine. Once the MAA is approved, OPEL would be authorized to market voclosporin in the European Union, Norway, Iceland, and Liechtenstein. As part of the agreement, Aurinia received a $50 million U.S. upfront cash payment with the potential to secure up to $50 million U.S. in additional regulatory and reimbursement milestone payments. In addition, Aurinia will receive tiered royalties ranging from 10 to 20 percent, dependent on net and annual sales following commercialization, along with additional milestone payments based on the attainment of certain annual sales by OPEL. Voclosporin will be provided to OPEL under a cost-plus supply agreement.

    "Lupus nephritis is a serious, complex condition that historically has lacked dedicated, approved treatment options," said Peter Greenleaf, President and Chief Executive Officer of Aurinia Pharmaceuticals. "We look forward to continuing to work with Otsuka to expand access to voclosporin and provide patients and physicians access to this new therapy that addresses a significant unmet need in lupus nephritis."

    About Lupus Nephritis

    LN is a serious manifestation of SLE, a chronic and complex autoimmune disease. Approximately one out of three of these individuals with SLE will develop LN. If poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney, resulting in kidney failure. Black and Asian individuals with SLE are four times more likely to develop LN and individuals of Hispanic ancestry are approximately twice as likely to develop the disease when compared with Caucasian individuals. Black and Hispanic individuals with SLE also tend to develop LN earlier and have poorer outcomes when compared to Caucasian individuals.

    About Aurinia

    Aurinia Pharmaceuticals, Inc. is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The Company's head office is in Victoria, British Columbia, its U.S. commercial hub is in Rockville, Maryland, and the Company focuses its development efforts globally.

    INDICATION AND IMPORTANT SAFETY INFORMATION

    INDICATIONS

    LUPKYNIS is indicated in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active LN. Limitations of Use: Safety and efficacy of LUPKYNIS have not been established in combination with cyclophosphamide. Use of LUPKYNIS is not recommended in this situation.

    IMPORTANT SAFETY INFORMATION

    BOXED WARNINGS: MALIGNANCIES AND SERIOUS INFECTIONS

    Increased risk for developing malignancies and serious infections with LUPKYNIS or other immunosuppressants that may lead to hospitalization or death.

    CONTRAINDICATIONS: LUPKYNIS is contraindicated in patients taking strong CYP3A4 inhibitors because of the increased risk of acute and/or chronic nephrotoxicity, and in patients who have had a serious/severe hypersensitivity reaction to LUPKYNIS or its excipients.

    WARNINGS AND PRECAUTIONS

    Lymphoma and Other Malignancies:
    Immunosuppressants, including LUPKYNIS, increase the risk of developing lymphomas and other malignancies, particularly of the skin. The risk appears to be related to increasing doses and duration of immunosuppression rather than to the use of any specific agent.

    Serious Infections: Immunosuppressants, including LUPKYNIS, increase the risk of developing bacterial, viral, fungal, and protozoal infections (including opportunistic infections), which may lead to serious, including fatal, outcomes.

    Nephrotoxicity: LUPKYNIS, like other CNIs, may cause acute and/or chronic nephrotoxicity. The risk is increased when CNIs are concomitantly administered with drugs associated with nephrotoxicity.

    Hypertension: Hypertension is a common adverse reaction of LUPKYNIS therapy and may require antihypertensive therapy.

    Neurotoxicity: LUPKYNIS, like other CNIs, may cause a spectrum of neurotoxicities: severe include posterior reversible encephalopathy syndrome (PRES), delirium, seizure, and coma; others include tremor, paresthesia, headache, and changes in mental status and/or motor and sensory functions.

    Hyperkalemia: Hyperkalemia, which may be serious and require treatment, has been reported with CNIs, including LUPKYNIS. Concomitant use of agents associated with hyperkalemia may increase the risk for hyperkalemia.

    QTc Prolongation: LUPKYNIS prolongs the QTc interval in a dose-dependent manner when dosed higher than the recommended lupus nephritis therapeutic dose. The use of LUPKYNIS in combination with other drugs that are known to prolong QTc may result in clinically significant QT prolongation.

    Immunizations: Avoid the use of live attenuated vaccines during treatment with LUPKYNIS. Inactivated vaccines noted to be safe for administration may not be sufficiently immunogenic during treatment with LUPKYNIS.

    Pure Red Cell Aplasia: Cases of pure red cell aplasia (PRCA) have been reported in patients treated with another CNI immunosuppressant. If PRCA is diagnosed, consider discontinuation of LUPKYNIS.

    Drug-Drug Interactions: Avoid co-administration of LUPKYNIS and strong CYP3A4 inhibitors or with strong or moderate CYP3A4 inducers. Reduce LUPKYNIS dosage when co-administered with moderate CYP3A4 inhibitors. Reduce dosage of certain P-gp substrates with narrow therapeutic windows when co-administered.

    ADVERSE REACTIONS

    The most common adverse reactions (>3%) were glomerular filtration rate decreased, hypertension, diarrhea, headache, anemia, cough, urinary tract infection, abdominal pain upper, dyspepsia, alopecia, renal impairment, abdominal pain, mouth ulceration, fatigue, tremor, acute kidney injury, and decreased appetite.

    SPECIFIC POPULATIONS

    Pregnancy/Lactation:
    May cause fetal harm. Advise not to breastfeed.

    Renal Impairment: Not recommended in patients with baseline eGFR ≤45 mL/min/1.73 m2 unless benefit exceeds risk. Severe renal impairment: Reduce LUPKYNIS dose.

    Mild and Moderate Hepatic Impairment: Reduce LUPKYNIS dose. Severe hepatic impairment: Avoid LUPKYNIS use.

    Please see Prescribing Information, including Boxed Warning, and Medication Guide for LUPKYNIS.

    Forward-Looking Statements

    Certain statements made in this press release may constitute forward-looking information within the meaning of applicable Canadian securities law and forward-looking statements within the meaning of applicable United States securities law. These forward-looking statements or information include but are not limited to statements or information with respect to: Aurinia's estimates as to the number of patients with SLE in the U.S. and the proportion of those persons who will develop LN; the estimated proportion of Black and Asian individuals, and individuals with Hispanic ancestry, compared to Caucasian individuals, to develop LN. It is possible that such results or conclusions may change based on further analyses of these data. Words such as "anticipate", "will", "believe", "estimate", "expect", "intend", "target", "plan", "goals", "objectives", "may" and other similar words and expressions, identify forward-looking statements. We have made numerous assumptions about the forward-looking statements and information contained herein, including among other things, assumptions about: the accuracy of the results from our clinical trials; and the accuracy of reported data from third party studies and reports. Even though the management of Aurinia believes that the assumptions made, and the expectations represented by such statements or information are reasonable, there can be no assurance that the forward-looking information will prove to be accurate.

    Forward-looking information by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aurinia to be materially different from any future results, performance or achievements expressed or implied by such forward-looking information. Should one or more of these risks and uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in forward-looking statements or information. Such risks, uncertainties and other factors include, among others, the following difficulties: we may experience in completing the commercialization of voclosporin; the market for the LN business may not be as estimated; and the results from our clinical studies and from third party studies and reports may not be accurate. Although we have attempted to identify factors that would cause actual actions, events or results to differ materially from those described in forward-looking statements and information, there may be other factors that cause actual results, performances, achievements or events to not be as anticipated, estimated or intended. Also, many of the factors are beyond our control. There can be no assurance that forward-looking statements or information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, you should not place undue reliance on forward-looking statements or information.

    All forward-looking information contained in this presentation is qualified by this cautionary statement. Additional information related to Aurinia, including a detailed list of the risks and uncertainties affecting Aurinia and its business, can be found in Aurinia's most recent annual report on Form 10-K available by accessing the U.S. Securities and Exchange Commission's Electronic Document Gathering and Retrieval System (EDGAR) website at www.sec.gov/edgar or the Canadian Securities Administrators' System for Electronic Document Analysis and Retrieval (SEDAR) website at www.sedar.com.

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  10. Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) (Aurinia or the Company) announced today the appointment of Dr. Brinda Balakrishnan, M.D., Ph.D., to the Company's Board of Directors effective June 14, 2021. Dr. Balakrishnan is Group Vice President, Corporate and Business Development of BioMarin Pharmaceutical Inc. ("BioMarin"), a global biotechnology company that develops and commercializes innovative therapies for patients with serious and life-threatening rare disorders. At BioMarin, Dr. Balakrishnan leads initiatives on corporate strategy, mergers and acquisitions, partnering and licensing.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210614005185/en/

    Dr. Brinda Balakrishnan, newly appointed Director to the Aurinia Pharmaceuticals Board. (Photo: Business Wire)

    Dr. Brinda Balakrishnan…

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) (Aurinia or the Company) announced today the appointment of Dr. Brinda Balakrishnan, M.D., Ph.D., to the Company's Board of Directors effective June 14, 2021. Dr. Balakrishnan is Group Vice President, Corporate and Business Development of BioMarin Pharmaceutical Inc. ("BioMarin"), a global biotechnology company that develops and commercializes innovative therapies for patients with serious and life-threatening rare disorders. At BioMarin, Dr. Balakrishnan leads initiatives on corporate strategy, mergers and acquisitions, partnering and licensing.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210614005185/en/

    Dr. Brinda Balakrishnan, newly appointed Director to the Aurinia Pharmaceuticals Board. (Photo: Business Wire)

    Dr. Brinda Balakrishnan, newly appointed Director to the Aurinia Pharmaceuticals Board. (Photo: Business Wire)

    "On behalf of the entire Company, it is an honor to welcome Dr. Balakrishnan to Aurinia's Board of Directors," commented Peter Greenleaf, President and Chief Executive Officer of Aurinia. "With her rich experience in medicine, biotech business development and the rare disease space, we are eager to leverage her input and insights as we continue in our mission to support and better treat people suffering with rare, autoimmune diseases, including lupus nephritis."

    "I am delighted to join the Board of Directors of Aurinia," said Dr. Balakrishnan. "The Company is at an exciting moment in its evolution, and I look forward to working with the Board and management team as Aurinia continues on its mission to serve people suffering from debilitating autoimmune diseases."

    Dr. Balakrishnan has been at BioMarin since 2016. Prior to joining BioMarin, Dr. Balakrishnan was the co-founder and Vice President of corporate strategy and product development at Vision Medicines, Inc., a start-up focused on developing treatments for rare ophthalmic diseases. Before Vision Medicines, she spent two years as a consultant at McKinsey & Company in the healthcare practice, serving clients across small biotech, large pharma, and healthcare provider groups on topics related to corporate strategy, corporate and business development, and operations. Prior to McKinsey, Dr. Balakrishnan was in business development at Genzyme.

    Dr. Balakrishnan earned a B.S. degree from the Massachusetts Institute of Technology (MIT) in chemical engineering and a Ph.D. from MIT in biomedical engineering and chemical engineering. She also earned her M.D. degree from Harvard Medical School and conducted her medical training in internal medicine at Beth Israel Deaconess Medical Center in Boston, a Harvard hospital.

    About Aurinia

    Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The Company's head office is in Victoria, British Columbia, its U.S. commercial hub is in Rockville, Maryland, and the Company focuses its development efforts globally.

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  11. Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) ("Aurinia" or the "Company") is pleased to announce that the eight incumbent directors of the Company were elected at the Company's annual general meeting (the "Meeting") held on June 7, 2021.

    Detailed results of the vote by proxy for the election of directors are provided below:

    Nominee

         

    Votes For (%)

         

    Votes Withheld (%)

    George M. Milne

         

    80.91

     

     

     

    19.09

    Peter Greenleaf

         

    92.18

     

     

     

    7.82

    David R.W. Jayne

         

    93.00

     

     

     

    7.00

    Joseph P. Hagan

         

    87.15

     

     

     

    12.85

    Daniel G. Billen

         

    95.64

     

     

     

    4.36

    R. Hector MacKay-Dunn

         

    93.27

     

     

     

    6.73

    Jill…

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) ("Aurinia" or the "Company") is pleased to announce that the eight incumbent directors of the Company were elected at the Company's annual general meeting (the "Meeting") held on June 7, 2021.

    Detailed results of the vote by proxy for the election of directors are provided below:

    Nominee

         

    Votes For (%)

         

    Votes Withheld (%)

    George M. Milne

         

    80.91

     

     

     

    19.09

    Peter Greenleaf

         

    92.18

     

     

     

    7.82

    David R.W. Jayne

         

    93.00

     

     

     

    7.00

    Joseph P. Hagan

         

    87.15

     

     

     

    12.85

    Daniel G. Billen

         

    95.64

     

     

     

    4.36

    R. Hector MacKay-Dunn

         

    93.27

     

     

     

    6.73

    Jill Leversage

         

    95.05

     

     

     

    4.95

    Timothy P. Walbert

         

    89.56

     

     

     

    10.44

    In addition, following final tallies of votes, all other matters voted on at the Meeting were also approved. Voting results on all matters voted on at the Meeting will be filed on SEDAR at www.sedar.com and EDGAR at www.edgar.com.

    About Aurinia

    Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The Company's head office is in Victoria, British Columbia, its U.S. commercial hub is in Rockville, Maryland, and the Company focuses its development efforts globally.

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  12. - New examination of AURORA 1 Phase 3 data demonstrates increased renal response rates with LUPKYNIS™ (voclosporin) used in combination with MMF and low-dose steroids in patients with lupus nephritis regardless of target urine protein creatinine ratio (UPCR) -  

    - The assessment follows the presentation of first interim results of AURORA 2 continuation study at EULAR 2021 -

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) (Aurinia or the Company) today presented an analysis of its Phase 3 AURORA 1 study data at the European Renal Association – European Dialysis and Transplant Association (ERA-EDTA) 2021 Congress. The presentation follows the recent introduction of new data from an interim analysis of the AURORA 2 continuation study at…

    - New examination of AURORA 1 Phase 3 data demonstrates increased renal response rates with LUPKYNIS™ (voclosporin) used in combination with MMF and low-dose steroids in patients with lupus nephritis regardless of target urine protein creatinine ratio (UPCR) -  

    - The assessment follows the presentation of first interim results of AURORA 2 continuation study at EULAR 2021 -

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) (Aurinia or the Company) today presented an analysis of its Phase 3 AURORA 1 study data at the European Renal Association – European Dialysis and Transplant Association (ERA-EDTA) 2021 Congress. The presentation follows the recent introduction of new data from an interim analysis of the AURORA 2 continuation study at the European Alliance of Associations for Rheumatology (EULAR) 2021 Congress.

    In the assessment presented at ERA-EDTA, researchers conducted a sensitivity study evaluating renal response (RR) with additional urine protein creatinine ratio (UPCR) targets given the efficacy demonstrated of voclosporin in terms of proteinuria reduction in the AURORA 1 study. This examination demonstrated that patients treated with voclosporin in addition to mycophenolate mofetil (MMF) and low-dose steroids achieved statistically significant increased renal response rates regardless of the level of UPCR, including at an even more stringent ≤0.3 mg/mg target. The data further support the efficacy and safety observed with voclosporin in the Phase 3 AURORA 1 trial.

    "This new look at the data on LUPKYNIS is significant because it demonstrates the ability of the therapy to deliver meaningful renal response rates at UPCR levels beyond the initial target in its Phase 3 study," said study co-author, Maria Dall'Era, M.D., Director, UCSF Lupus Clinic and Rheumatology Clinical Research Center, Department of Medicine, University of California, San Francisco. "Multiple previous studies have suggested that level of proteinuria represents the best clinical predictor of long-term kidney outcome. Thus, seeing the benefits of LUPKYNIS even in the most stringent UPCR levels is encouraging for lupus nephritis patients and the physicians treating this challenging condition."

    The ERA-EDTA assessment of Aurinia's Phase 3 AURORA 1 study included a total of 179 participants in the voclosporin (23.7 mg BID) arm and 178 participants in the control arm from the AURORA 1 trial. All participants received MMF (target 1 g BID) and low-dose oral steroids (initiated at 20-25 mg/day and tapered to 2.5 mg/day at 16 weeks). The UPCR component of RR was revised to include UPCR targets at 0.2 mg/mg intervals above and below the original ≤0.5 target used for the primary endpoint in AURORA 1 (i.e., ≤0.7 mg/mg or ≤0.3 mg/mg, respectively). Complete renal response (CRR) defined as achievement of UPCR ≤0.5 mg/mg with stable renal function (eGFR ≥60 mL/min/1.73 m2 and no decrease >20% from baseline) in the presence of sustained, low-dose steroids (in the 8 weeks prior to assessment) and no use of rescue medication. Complete renal response analysis at approximately one year included Week 52 data from AURORA 1. Odds ratios for RR at 26 weeks and 52 weeks of treatment were analyzed using a logistic regression model with terms for treatment, baseline UPCR, biopsy class, and MMF use at baseline and region.

    Renal Response at One Year

     

    Control (n=178)

    Voclosporin (n=179)

    Odds Ratio vs Control

    UPCR Threshold

    Percent of participants with renal response

    ≤0.7 mg/mg

    32.0%

    46.9%

    2.07

    ≤0.5 mg/mg

    22.5%

    40.8%

    2.65

    ≤0.3 mg/mg

    15.7%

    28.5%

    2.27

    In the AURORA 1 trial, LUPKYNIS was well tolerated with no unexpected safety signals. Serious adverse events (SAEs) were reported in 21% of those treated with LUPKNYIS and in 21% of those in the control group. Infection and infestations were the most commonly reported SAEs, in 10% of the LUPKYNIS group and 11% of the control group. Overall mortality in the AURORA 1 trial was low, with six deaths observed; one in the LUPKYNIS group and five in the control group. Additionally, the LUPKYNIS group showed no notable decrease at Week 52 in mean eGFR or increase in mean blood pressure, lipids or glucose, which are common adverse events associated with traditional calcineurin inhibitors (CNIs).

    About Lupus Nephritis

    LN is a serious manifestation of systemic lupus erythematosus (SLE), a chronic and complex autoimmune disease. About 200,000-300,000 people live with SLE in the U.S. and approximately one out of three of these individuals develop LN. If poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney, resulting in kidney failure. Black and Asian individuals with SLE are four times more likely to develop LN and individuals of Hispanic ancestry are approximately twice as likely to develop the disease when compared with Caucasian individuals. Black and Hispanic individuals with SLE also tend to develop LN earlier and have poorer outcomes when compared to Caucasian individuals.

    About LUPKYNIS

    LUPKYNIS is the first FDA-approved oral treatment for the treatment of adult patients with active LN. A novel, structurally modified CNI, LUPKYNIS has a dual mechanism of action, acting as an immunosuppressant through inhibition of T-cell activation and cytokine production and promoting podocyte stability in the kidney. The recommended starting dose of LUPKYNIS is three capsules twice daily with no requirement for serum drug monitoring. Dose modifications can be made based on Aurinia's proprietary personalized eGFR based dosing protocol. Boxed Warning, warnings and precautions for LUPKYNIS are consistent with those of other CNI-immunosuppressive treatments.

    About Aurinia

    Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The Company's head office is in Victoria, British Columbia, its U.S. commercial hub is in Rockville, Maryland, and the Company focuses its development efforts globally.

    INDICATION AND IMPORTANT SAFETY INFORMATION

    INDICATIONS

    LUPKYNIS is indicated in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active LN. Limitations of Use: Safety and efficacy of LUPKYNIS have not been established in combination with cyclophosphamide. Use of LUPKYNIS is not recommended in this situation.

    IMPORTANT SAFETY INFORMATION

    BOXED WARNINGS: MALIGNANCIES AND SERIOUS INFECTIONS

    Increased risk for developing malignancies and serious infections with LUPKYNIS or other immunosuppressants that may lead to hospitalization or death.

    CONTRAINDICATIONS: LUPKYNIS is contraindicated in patients taking strong CYP3A4 inhibitors because of the increased risk of acute and/or chronic nephrotoxicity, and in patients who have had a serious/severe hypersensitivity reaction to LUPKYNIS or its excipients.

    WARNINGS AND PRECAUTIONS

    Lymphoma and Other Malignancies: Immunosuppressants, including LUPKYNIS, increase the risk of developing lymphomas and other malignancies, particularly of the skin. The risk appears to be related to increasing doses and duration of immunosuppression rather than to the use of any specific agent.

    Serious Infections: Immunosuppressants, including LUPKYNIS, increase the risk of developing bacterial, viral, fungal, and protozoal infections (including opportunistic infections), which may lead to serious, including fatal, outcomes.

    Nephrotoxicity: LUPKYNIS, like other CNIs, may cause acute and/or chronic nephrotoxicity. The risk is increased when CNIs are concomitantly administered with drugs associated with nephrotoxicity.

    Hypertension: Hypertension is a common adverse reaction of LUPKYNIS therapy and may require antihypertensive therapy.

    Neurotoxicity: LUPKYNIS, like other CNIs, may cause a spectrum of neurotoxicities: severe include posterior reversible encephalopathy syndrome (PRES), delirium, seizure, and coma; others include tremor, paresthesia, headache, and changes in mental status and/or motor and sensory functions.

    Hyperkalemia: Hyperkalemia, which may be serious and require treatment, has been reported with CNIs, including LUPKYNIS. Concomitant use of agents associated with hyperkalemia may increase the risk for hyperkalemia.

    QTc Prolongation: LUPKYNIS prolongs the QTc interval in a dose-dependent manner when dosed higher than the recommended lupus nephritis therapeutic dose. The use of LUPKYNIS in combination with other drugs that are known to prolong QTc may result in clinically significant QT prolongation.

    Immunizations: Avoid the use of live attenuated vaccines during treatment with LUPKYNIS. Inactivated vaccines noted to be safe for administration may not be sufficiently immunogenic during treatment with LUPKYNIS.

    Pure Red Cell Aplasia: Cases of pure red cell aplasia (PRCA) have been reported in patients treated with another CNI immunosuppressant. If PRCA is diagnosed, consider discontinuation of LUPKYNIS.

    Drug-Drug Interactions: Avoid co-administration of LUPKYNIS and strong CYP3A4 inhibitors or with strong or moderate CYP3A4 inducers. Reduce LUPKYNIS dosage when co-administered with moderate CYP3A4 inhibitors. Reduce dosage of certain P-gp substrates with narrow therapeutic windows when co-administered.

    ADVERSE REACTIONS

    The most common adverse reactions (>3%) were glomerular filtration rate decreased, hypertension, diarrhea, headache, anemia, cough, urinary tract infection, abdominal pain upper, dyspepsia, alopecia, renal impairment, abdominal pain, mouth ulceration, fatigue, tremor, acute kidney injury, and decreased appetite.

    SPECIFIC POPULATIONS

    Pregnancy/Lactation: May cause fetal harm. Advise not to breastfeed.

    Renal Impairment: Not recommended in patients with baseline eGFR ≤45 mL/min/1.73 m2 unless benefit exceeds risk. Severe renal impairment: Reduce LUPKYNIS dose.

    Mild and Moderate Hepatic Impairment: Reduce LUPKYNIS dose. Severe hepatic impairment: Avoid LUPKYNIS use.

    Please see Prescribing Information, including Boxed Warning, and Medication Guide for LUPKYNIS.

    Forward-Looking Statements

    Certain statements made in this press release may constitute forward-looking information within the meaning of applicable Canadian securities law and forward-looking statements within the meaning of applicable United States securities law. These forward-looking statements or information include but are not limited to statements or information with respect to: Aurinia's estimates as to the number of patients with SLE in the U.S. and the proportion of those persons who will develop LN; the estimated proportion of Black and Asian individuals, and individuals with Hispanic ancestry, compared to Caucasian individuals, to develop LN. It is possible that such results or conclusions may change based on further analyses of these data. Words such as "anticipate", "will", "believe", "estimate", "expect", "intend", "target", "plan", "goals", "objectives", "may" and other similar words and expressions, identify forward-looking statements. We have made numerous assumptions about the forward-looking statements and information contained herein, including among other things, assumptions about: the accuracy of the results from our clinical trials; and the accuracy of reported data from third party studies and reports. Even though the management of Aurinia believes that the assumptions made, and the expectations represented by such statements or information are reasonable, there can be no assurance that the forward-looking information will prove to be accurate.

    Forward-looking information by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aurinia to be materially different from any future results, performance or achievements expressed or implied by such forward-looking information. Should one or more of these risks and uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in forward-looking statements or information. Such risks, uncertainties and other factors include, among others, the following difficulties: we may experience in completing the commercialization of voclosporin; the market for the LN business may not be as estimated; and the results from our clinical studies and from third party studies and reports may not be accurate. Although we have attempted to identify factors that would cause actual actions, events or results to differ materially from those described in forward-looking statements and information, there may be other factors that cause actual results, performances, achievements or events to not be as anticipated, estimated or intended. Also, many of the factors are beyond our control. There can be no assurance that forward-looking statements or information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, you should not place undue reliance on forward-looking statements or information.

    All forward-looking information contained in this presentation is qualified by this cautionary statement. Additional information related to Aurinia, including a detailed list of the risks and uncertainties affecting Aurinia and its business, can be found in Aurinia's most recent annual report on Form 10-K available by accessing the U.S. Securities and Exchange Commission's Electronic Document Gathering and Retrieval System (EDGAR) website at www.sec.gov/edgar or the Canadian Securities Administrators' System for Electronic Document Analysis and Retrieval (SEDAR) website at www.sedar.com.

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  13. - venBio promoted Richard Gaster M.D., Ph.D. to Managing Partner

    venBio today announced the closing of venBio Global Strategic Fund IV, LP ("venBio Fund IV"), its fourth life sciences venture capital fund, exceeding its target and closing on approximately $550 million in capital commitments in an oversubscribed fundraise. The capital was raised from existing and new investors, including a broad range of institutional investors comprising corporate pensions, financial institutions, university endowments and foundations, family offices and funds-of-funds.

    Led by Managing Partners Corey Goodman, Ph.D., Robert Adelman, M.D., Aaron Royston, M.D., and Richard Gaster, M.D., Ph.D., venBio Fund IV will continue to invest primarily in therapeutics…

    - venBio promoted Richard Gaster M.D., Ph.D. to Managing Partner

    venBio today announced the closing of venBio Global Strategic Fund IV, LP ("venBio Fund IV"), its fourth life sciences venture capital fund, exceeding its target and closing on approximately $550 million in capital commitments in an oversubscribed fundraise. The capital was raised from existing and new investors, including a broad range of institutional investors comprising corporate pensions, financial institutions, university endowments and foundations, family offices and funds-of-funds.

    Led by Managing Partners Corey Goodman, Ph.D., Robert Adelman, M.D., Aaron Royston, M.D., and Richard Gaster, M.D., Ph.D., venBio Fund IV will continue to invest primarily in therapeutics companies that are developing biopharmaceuticals for unmet medical needs. The venBio team takes an active role with each of their portfolio companies, providing strategic guidance on a range of business activities including intellectual property, chemistry, manufacturing and controls (CMC), as well as assisting with clinical trials: from trial design to endpoints to regulatory deliberations.

    "We remain committed to our unique approach and strategy and hope the results speak for themselves – our portfolio companies have delivered four drugs to market for six clinical indications, and another seven drug candidates are demonstrating promising late-stage efficacy," said Dr. Adelman.

    "Our portfolio is directly impacting patient lives and we could not have accomplished that without the ongoing commitment from our limited partners, and we are grateful for their continued support for Fund IV," said Dr. Goodman. "With Fund IV we intend to continue our proven approach of helping to build 12-15 companies per fund while doubling down on winners by providing stronger support for our portfolio companies in crossover rounds and at IPO."

    "We are delighted to announce with the closing of Fund IV, the promotion of Dr. Rich Gaster to Managing Partner," said Dr. Royston. "Our core investment team and investment strategy remain the same as we launch our new fund."

    "Our strategy at venBio has always been to turn exceptional science into impactful medicine," said Dr. Gaster. "Every member of our team is involved in every investment that we make, and we believe this collaborative approach is what helps drive our success."

    Sidley Austin LLP served as legal adviser to venBio.

    About venBio

    Established in 2011, venBio is a life science venture capital firm that focuses on novel therapeutics for unmet medical needs. Since inception in 2011, venBio has raised nearly $1.5 billion in capital commitments and led investment rounds in 34 companies, including: venBio-founded Labrys Biologics (acquired by Teva) and ALX Oncology (NASDAQ:ALXO); Aragon Pharmaceuticals (acquired by Johnson & Johnson); Seragon Pharmaceuticals (acquired by Roche); Aurinia Pharmaceuticals (NASDAQ:AUPH); Apellis Pharmaceuticals (NASDAQ:APLS); Turning Point Therapeutics (NASDAQ:TPTX); Precision Biosciences (NASDAQ:DTIL); Akero Therapeutics (NASDAQ:AKRO); Harmony Biosciences (NASDAQ:HRMY); and Pharvaris (NASDAQ:PHVS). For more information, please visit www.venbio.com.

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  14. Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) (the "Company") today announced that members of the executive management team will participate in a fireside chat during the Jefferies Virtual Healthcare Conference on Thursday, June 3, 2021 at 11:30 a.m. ET.

    In order to participate in the audio webcast, interested parties can access the live webcast under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will be available on Aurinia's website.

    ABOUT AURINIA

    Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical…

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) (the "Company") today announced that members of the executive management team will participate in a fireside chat during the Jefferies Virtual Healthcare Conference on Thursday, June 3, 2021 at 11:30 a.m. ET.

    In order to participate in the audio webcast, interested parties can access the live webcast under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will be available on Aurinia's website.

    ABOUT AURINIA

    Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The Company has introduced LUPKYNIS™ (voclosporin), the first FDA-approved oral therapy dedicated for the treatment of adult patients with active lupus nephritis (LN). The Company's head office is in Victoria, British Columbia, its U.S. commercial hub is in Rockville, Maryland, and the Company focuses its development efforts globally.

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  15. - Individuals treated with LUPKYNIS sustained meaningful reductions in proteinuria with no change in mean eGFR at 104 weeks of treatment -

    - These data, the longest-available outcomes data with LUPKYNIS for the treatment of lupus nephritis to-date, will be presented at European Alliance of Associations for Rheumatology (EULAR) 2021 Congress June 2-5, 2021 -

    - An additional EULAR presentation will highlight real-world evidence suggesting reduced economic burden to healthcare payers when achieving lower lupus nephritis (LN) disease activity -

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) (Aurinia or the Company) announced today that a supportive interim analysis of its AURORA 2 continuation study will be presented at the upcoming European…

    - Individuals treated with LUPKYNIS sustained meaningful reductions in proteinuria with no change in mean eGFR at 104 weeks of treatment -

    - These data, the longest-available outcomes data with LUPKYNIS for the treatment of lupus nephritis to-date, will be presented at European Alliance of Associations for Rheumatology (EULAR) 2021 Congress June 2-5, 2021 -

    - An additional EULAR presentation will highlight real-world evidence suggesting reduced economic burden to healthcare payers when achieving lower lupus nephritis (LN) disease activity -

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) (Aurinia or the Company) announced today that a supportive interim analysis of its AURORA 2 continuation study will be presented at the upcoming European Alliance of Associations for Rheumatology (EULAR) 2021 Congress June 2-5, 2021.

    Subjects who completed one year of treatment in Aurinia's Phase 3 AURORA study (AURORA 1) were eligible to enroll in the two-year, blinded, controlled continuation study (AURORA 2). The interim analysis to be presented at EULAR evaluated subjects with up to two years of total treatment: one year from AURORA 1 and up to one year in AURORA 2. Previously reported results from AURORA 1 and the Phase 2 AURA-LV study showed that compared with mycophenolate mofetil (MMF) and low-dose steroids alone, the addition of voclosporin significantly increased the renal response rate and reduced proteinuria, as measured by urine protein creatinine ratio (UPCR), in subjects with lupus nephritis (LN) at approximately one year of treatment (48 weeks in AURA-LV and 52 weeks in AURORA 1). The interim analysis of AURORA 2 showed that subjects in the LUPKYNIS treatment arm sustained meaningful reductions in proteinuria, with no change in mean estimated glomerular filtration rate (eGFR) at 104 weeks of treatment.

    "Following the enhanced renal response rates achieved in AURORA 1, these additional data show that LUPKYNIS also provides the ability to sustain positive outcomes over time," said Amit Saxena, M.D., Assistant Professor at the Department of Medicine at NYU Langone Medical Center. "The strong and growing pool of data available on LUPKYNIS clearly demonstrates the clinical value and safety of this therapy for a patient population that has historically been challenged with a lack of effective treatment options."

    An interim analysis of the 216 blinded AURORA 2 study subjects (116 voclosporin; 100 control arm) was performed as part of the US New Drug Application. Data from 124 subjects (73 voclosporin; 51 control arm) who had received 104 weeks of continuous treatment was analyzed. Proteinuria continued to improve with a greater reduction in UPCR from pre-treatment baseline to year two observed in the voclosporin arm compared to the control arm (-3.1 vs -2.1 mg/mg; p=0.0004). A greater reduction in proteinuria between arms was also observed between 1 and 2 years (1.0 vs 0.6 mg/mg; voclosporin vs control). Renal function as determined by eGFR remained stable over 104 weeks in both groups compared to baseline assessments. Mean eGFR: 79.6 vs 79.0 mL/min for the voclosporin arm and 78.9 vs 82.9 mL/min for the control arm.

    Additionally, there were no unexpected new AEs observed in patients who continued with voclosporin treatment compared to control-treated patients for more than one year.

    "Seeing these first results from our continuation study is extremely encouraging as we continue to work to bring LUPKYNIS to patients following its FDA approval earlier this year," said Neil Solomons, M.D., Chief Medical Officer at Aurinia. "We look forward to providing updates on our continuation study results and continuing to support patients and physicians in making informed decisions about the treatment of LN."

    About Lupus Nephritis

    Lupus nephritis is a serious manifestation of systemic lupus erythematosus (SLE), a chronic and complex autoimmune disease. About 200,000-300,000 people live with SLE in the U.S. and approximately one out of three of these individuals develop LN. If poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney, resulting in kidney failure. Black and Asian individuals with SLE are four times more likely to develop LN and individuals of Hispanic ancestry are approximately twice as likely to develop the disease when compared with Caucasian individuals. Black and Hispanic individuals with SLE also tend to develop LN earlier and have poorer outcomes when compared to Caucasian individuals.

    About LUPKYNIS

    LUPKYNIS is the first FDA-approved oral treatment for the treatment of adult patients with active LN. A novel, structurally modified calcineurin inhibitor (CNI), LUPKYNIS has a dual mechanism of action, acting as an immunosuppressant through inhibition of T-cell activation and cytokine production and promoting podocyte stability in the kidney. The recommended starting dose of LUPKYNIS is three capsules twice daily with no requirement for serum drug monitoring. Dose modifications can be made based on Aurinia's proprietary personalized eGFR based dosing protocol. Boxed Warning, warnings and precautions for LUPKYNIS are consistent with those of other CNI-immunosuppressive treatments.

    About Aurinia

    Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The Company's head office is in Victoria, British Columbia, its U.S. commercial hub is in Rockville, Maryland, and the Company focuses its development efforts globally.

    INDICATION AND IMPORTANT SAFETY INFORMATION

    INDICATIONS

    LUPKYNIS is indicated in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active LN. Limitations of Use: Safety and efficacy of LUPKYNIS have not been established in combination with cyclophosphamide. Use of LUPKYNIS is not recommended in this situation.

    IMPORTANT SAFETY INFORMATION

    BOXED WARNINGS: MALIGNANCIES AND SERIOUS INFECTIONS

    Increased risk for developing malignancies and serious infections with LUPKYNIS or other immunosuppressants that may lead to hospitalization or death.

    CONTRAINDICATIONS

    LUPKYNIS is contraindicated in patients taking strong CYP3A4 inhibitors because of the increased risk of acute and/or chronic nephrotoxicity, and in patients who have had a serious/severe hypersensitivity reaction to LUPKYNIS or its excipients.

    WARNINGS AND PRECAUTIONS

    Lymphoma and Other Malignancies: Immunosuppressants, including LUPKYNIS, increase the risk of developing lymphomas and other malignancies, particularly of the skin. The risk appears to be related to increasing doses and duration of immunosuppression rather than to the use of any specific agent.

    Serious Infections: Immunosuppressants, including LUPKYNIS, increase the risk of developing bacterial, viral, fungal, and protozoal infections (including opportunistic infections), which may lead to serious, including fatal, outcomes.

    Nephrotoxicity: LUPKYNIS, like other CNIs, may cause acute and/or chronic nephrotoxicity. The risk is increased when CNIs are concomitantly administered with drugs associated with nephrotoxicity.

    Hypertension: Hypertension is a common adverse reaction of LUPKYNIS therapy and may require antihypertensive therapy.

    Neurotoxicity: LUPKYNIS, like other CNIs, may cause a spectrum of neurotoxicities: severe include posterior reversible encephalopathy syndrome (PRES), delirium, seizure, and coma; others include tremor, paresthesia, headache, and changes in mental status and/or motor and sensory functions.

    Hyperkalemia: Hyperkalemia, which may be serious and require treatment, has been reported with CNIs, including LUPKYNIS. Concomitant use of agents associated with hyperkalemia may increase the risk for hyperkalemia.

    QTc Prolongation: LUPKYNIS prolongs the QTc interval in a dose-dependent manner when dosed higher than the recommended lupus nephritis therapeutic dose. The use of LUPKYNIS in combination with other drugs that are known to prolong QTc may result in clinically significant QT prolongation.

    Immunizations: Avoid the use of live attenuated vaccines during treatment with LUPKYNIS. Inactivated vaccines noted to be safe for administration may not be sufficiently immunogenic during treatment with LUPKYNIS.

    Pure Red Cell Aplasia: Cases of pure red cell aplasia (PRCA) have been reported in patients treated with another CNI immunosuppressant. If PRCA is diagnosed, consider discontinuation of LUPKYNIS.

    Drug-Drug Interactions: Avoid co-administration of LUPKYNIS and strong CYP3A4 inhibitors or with strong or moderate CYP3A4 inducers. Reduce LUPKYNIS dosage when co-administered with moderate CYP3A4 inhibitors. Reduce dosage of certain P-gp substrates with narrow therapeutic windows when co-administered.

    ADVERSE REACTIONS

    The most common adverse reactions (>3%) were glomerular filtration rate decreased, hypertension, diarrhea, headache, anemia, cough, urinary tract infection, abdominal pain upper, dyspepsia, alopecia, renal impairment, abdominal pain, mouth ulceration, fatigue, tremor, acute kidney injury, and decreased appetite.

    SPECIFIC POPULATIONS

    Pregnancy/Lactation: May cause fetal harm. Advise not to breastfeed.

    Renal Impairment: Not recommended in patients with baseline eGFR ≤45 mL/min/1.73 m2 unless benefit exceeds risk. Severe renal impairment: Reduce LUPKYNIS dose.

    Mild and Moderate Hepatic Impairment: Reduce LUPKYNIS dose. Severe hepatic impairment: Avoid LUPKYNIS use.

    Please see Prescribing Information, including Boxed Warning, and Medication Guide for LUPKYNIS.

    Forward-Looking Statements

    Certain statements made in this press release may constitute forward-looking information within the meaning of applicable Canadian securities law and forward-looking statements within the meaning of applicable United States securities law. These forward-looking statements or information include but are not limited to statements or information with respect to: Aurinia's estimates as to the number of patients with SLE in the U.S. and the proportion of those persons who will develop LN; the estimated proportion of Black and Asian individuals, and individuals with Hispanic ancestry, compared to Caucasian individuals, to develop LN; Aurinia enhancing access with a variety of patient services and healthcare engagement initiatives. It is possible that such results or conclusions may change based on further analyses of these data. Words such as "anticipate", "will", "believe", "estimate", "expect", "intend", "target", "plan", "goals", "objectives", "may" and other similar words and expressions, identify forward-looking statements. We have made numerous assumptions about the forward-looking statements and information contained herein, including among other things, assumptions about: the accuracy of the results from our clinical trials; and the accuracy of reported data from third party studies and reports. Even though the management of Aurinia believes that the assumptions made, and the expectations represented by such statements or information are reasonable, there can be no assurance that the forward-looking information will prove to be accurate.

    Forward-looking information by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aurinia to be materially different from any future results, performance or achievements expressed or implied by such forward-looking information. Should one or more of these risks and uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in forward-looking statements or information. Such risks, uncertainties and other factors include, among others, the following difficulties: we may experience in completing the commercialization of voclosporin; the market for the LN business may not be as estimated; and the results from our clinical studies and from third party studies and reports may not be accurate. Although we have attempted to identify factors that would cause actual actions, events or results to differ materially from those described in forward-looking statements and information, there may be other factors that cause actual results, performances, achievements or events to not be as anticipated, estimated or intended. Also, many of the factors are beyond our control. There can be no assurance that forward-looking statements or information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, you should not place undue reliance on forward-looking statements or information.

    All forward-looking information contained in this presentation is qualified by this cautionary statement. Additional information related to Aurinia, including a detailed list of the risks and uncertainties affecting Aurinia and its business, can be found in Aurinia's most recent annual report on Form 10-K available by accessing the U.S. Securities and Exchange Commission's Electronic Document Gathering and Retrieval System (EDGAR) website at www.sec.gov/edgar or the Canadian Securities Administrators' System for Electronic Document Analysis and Retrieval (SEDAR) website at www.sedar.com.

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  16. Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) (the "Company") today announced that members of the executive management team will participate in two upcoming investor conferences:

    • RBC Capital Markets Global Healthcare Conference on Wednesday, May 19, 2021 at 10:55 a.m. ET; and
    • Oppenheimer Rare & Orphan Disease Summit on Friday, May 21, 2021 at 10:45 a.m. ET.

    In order to participate in the audio webcast, interested parties can access the live webcast under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will be available on Aurinia's website.

    ABOUT AURINIA

    Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies…

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) (the "Company") today announced that members of the executive management team will participate in two upcoming investor conferences:

    • RBC Capital Markets Global Healthcare Conference on Wednesday, May 19, 2021 at 10:55 a.m. ET; and
    • Oppenheimer Rare & Orphan Disease Summit on Friday, May 21, 2021 at 10:45 a.m. ET.

    In order to participate in the audio webcast, interested parties can access the live webcast under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will be available on Aurinia's website.

    ABOUT AURINIA

    Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The Company has introduced LUPKYNIS™ (voclosporin), the first FDA-approved oral therapy dedicated for the treatment of adult patients with active lupus nephritis (LN). The Company's head office is in Victoria, British Columbia, its U.S. commercial hub is in Rockville, Maryland, and the Company focuses its development efforts globally.

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  17. – Company-sponsored program seeks proposals to help patients in the U.S. make informed health choices and support underserved populations with these conditions –

    – Submission process opens on World Lupus Day, Monday May 10, deadline to submit proposals is June 1, 2021 –

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) (Aurinia or the Company) today, in recognition of World Lupus Day, affirmed its commitment to increasing access to equitable healthcare for individuals living with the autoimmune disease systemic lupus erythematosus (SLE) and lupus nephritis (LN) through the sponsorship of grants to establish community-focused patient navigator programs. LN is one of the most serious and common complications of SLE and affects significantly…

    – Company-sponsored program seeks proposals to help patients in the U.S. make informed health choices and support underserved populations with these conditions –

    – Submission process opens on World Lupus Day, Monday May 10, deadline to submit proposals is June 1, 2021 –

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) (Aurinia or the Company) today, in recognition of World Lupus Day, affirmed its commitment to increasing access to equitable healthcare for individuals living with the autoimmune disease systemic lupus erythematosus (SLE) and lupus nephritis (LN) through the sponsorship of grants to establish community-focused patient navigator programs. LN is one of the most serious and common complications of SLE and affects significantly more Black, Asian, and Hispanic individuals living with SLE than non-Hispanic white individuals with the condition. If left untreated, LN can cause irreversible kidney damage and increases the risk of kidney failure, cardiac events, and death.

    The Request for Proposals (RFP) seeks submissions from U.S-focused patient advocacy organizations with a goal of addressing healthcare disparities faced by the underserved LN community and providing the education needed for patients to make informed choices about their health. Grant awards will be provided to organizations who are committed to implementing patient navigation programs that target disadvantaged populations and those most at risk of developing LN. As a result of the global COVID-19 pandemic, healthcare navigation programs are needed by patients now more than ever. A recent World Lupus Federation survey found that almost half of patients surveyed (approximately 3,000 patients) reported decreased access to at least one aspect of lupus healthcare during the last three months due to the pandemici.

    "Patient navigation can be critical for those living with SLE and LN. Individualized support helps to navigate the complexities of our healthcare system. This is particularly important now more than ever with all of the challenges, confusion, and delays in care caused by the COVID-19 pandemic," said Christine Lindsay, Vice President, Professional & Advocacy Relations. "We look forward to supporting community organizations to ensure patients are connected with the resources needed to help effectively manage this serious disease."

    The grant awards aim to ensure that patients are educated about the importance of routine screenings and medical appointments; that patient's basic needs are met; and that patients are connected with the resources needed to receive ongoing treatment and medical care. Organizations are encouraged to submit applications by June 1, 2021. The full RFP can be found here.

    "Systemic lupus erythematosus (SLE) and lupus nephritis (LN) are conditions that are often challenging to not only diagnose but also to treat. Disease management requires a personalized approach for each patient, with routine urine testing and regular physician visits to monitor disease activity," said Sharon Dowell, M.D., Associate Professor of Medicine Division of Rheumatology, Howard University College of Medicine. "These conditions may disproportionately impact disadvantaged communities, and a health navigator can most certainly provide valuable support to ensure that each patient gets the care they need to achieve the best health outcomes."

    About Lupus Nephritis

    LN is a serious manifestation of SLE, a chronic and complex autoimmune disease. If poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney, resulting in kidney failure. Black and Asian individuals with SLE are four times more likely to develop LN and individuals of Hispanic ancestry are approximately twice as likely to develop the disease when compared with Caucasian individuals. Black and Hispanic individuals with SLE also tend to develop LN earlier and have poorer outcomes when compared to Caucasian individuals.

    About Aurinia

    Aurinia is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The company recently introduced the first FDA-approved oral therapy dedicated for the treatment of adult patients with active lupus nephritis (LN). Aurinia's head office is in Victoria, British Columbia, its U.S. commercial hub is in Rockville, Maryland, and development efforts are focused globally.


    i 1. World Lupus Federation 2021 Survey "The Impact of the COVID-19 Pandemic on People Living with Lupus; Accessed 4/26/2021 Hyperlink.to survey; Press Release Hyperlink

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  18. Study results demonstrate that LUPKYNIS in combination with typical standard of care (SoC) led to statistically superior complete renal response rates compared to treatment with SoC alone

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) ("Aurinia" or the "Company") today announced that The Lancet, an international, peer-reviewed medical journal, published the results of the Company's Phase 3 AURORA 1 study evaluating LUPKYNIS (voclosporin) in adults with lupus nephritis (LN). The AURORA 1 study results demonstrate that LUPKYNIS in combination with mycophenolate mofetil (MMF) and low-dose corticosteroids led to statistically superior complete renal response rates at 52 weeks compared to treatment with MMF and low-dose corticosteroids alone…

    Study results demonstrate that LUPKYNIS in combination with typical standard of care (SoC) led to statistically superior complete renal response rates compared to treatment with SoC alone

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) ("Aurinia" or the "Company") today announced that The Lancet, an international, peer-reviewed medical journal, published the results of the Company's Phase 3 AURORA 1 study evaluating LUPKYNIS (voclosporin) in adults with lupus nephritis (LN). The AURORA 1 study results demonstrate that LUPKYNIS in combination with mycophenolate mofetil (MMF) and low-dose corticosteroids led to statistically superior complete renal response rates at 52 weeks compared to treatment with MMF and low-dose corticosteroids alone, with a comparable safety profile. In fact, separation in efficacy between treatment groups was observed as early as 4 weeks. MMF and corticosteroids are typical SoC immunosuppressive agents used for the treatment of LN. On January 22, 2021, the U.S. Food and Drug Administration (FDA) approved LUPKYNIS in combination with a background immunosuppressive therapy regimen to treat adult patients with active LN.

    "Lupus nephritis can be a devastating condition if not diagnosed and managed early," stated Brad H. Rovin, M.D., Professor of Medicine and the Director of the Division of Nephrology, Ohio State University Wexler Medical Center, an AURORA clinical trial investigator and the lead author of the publication. "The publication of AURORA 1 data validates the importance of voclosporin (LUPKYNIS) in early disease intervention for LN. These data establish voclosporin as an efficacious and safe, rapid-acting new treatment option for patients in need."

    The published AURORA 1 results are based on the global Phase 3 randomized, double-blind, placebo-controlled study (NCT03021499) designed to evaluate the efficacy and safety of LUPKYNIS (23.7 mg twice daily) when added to background therapy of MMF and low-dose corticosteroids, compared to background therapy alone in an ethnically and racially diverse patient population with active LN.

    The AURORA 1 study enrolled 357 patients with a diagnosis of systemic lupus erythematosus (SLE) and LN according to the American College of Rheumatology criteria and a kidney biopsy within two years that showed Class III, IV and/or V LN. The primary endpoint was complete renal response at 52 weeks defined as urine protein creatinine ratio (UPCR) ≤0.5 mg/mg, with stable renal function (defined as estimated glomerular filtration rate [eGFR] ≥60 mL/min/1.73 m2 or no confirmed decrease from baseline in eGFR of >20%), no administration of rescue medication, and no more than 10 mg prednisone equivalent per day for three or more consecutive days or for seven or more days during Weeks 44 through 52. Key secondary hierarchical endpoints were complete renal response (CR) at Week 24 (based on primary endpoint definition with steroid dosing assessed during Weeks 16 through 24), partial renal response (PR), defined as a 50% reduction in UPCR from baseline, at Weeks 24 and 52, time to UPCR of ≤0.5 mg/mg and time to 50% reduction in UPCR from baseline.

    AURORA 1 met its primary endpoint, achieving statistically superior complete renal response rates of 41% in the LUPKYNIS group versus 23% in the control group (odds ratio [OR] 2.65, 95% confidence interval [CI] 1.64-4.27; p < 0.0001). LUPKYNIS also achieved statistical significance in all pre-specified hierarchical secondary endpoints, including improved time to 50% reduction from baseline in UPCR or and time to UPCR <0.5 mg/mg compared to control. The robustness of the data was also supported by all pre-specified subgroup analyses (age, sex, race, biopsy class, region and MMF use at screening) favoring LUPKYNIS.

    LUPKYNIS was well tolerated with no unexpected safety signals. Serious adverse events (SAEs) were reported in 21% of those treated with LUPKNYIS and in 21% of those in the control group. Infection and infestations were the most commonly reported SAEs, in 10% of the LUPKYNIS group and 11% of the control group. Overall mortality in the AURORA 1 trial was low, with six deaths observed; one in the LUPKYNIS group and five in the control group. Additionally, the LUPKYNIS group showed no notable decrease at Week 52 in mean eGFR or increase in mean blood pressure, lipids or glucose, which are common adverse events associated with traditional calcineurin inhibitors (CNIs).

    "The FDA approval of LUPKYNIS and the publication of the AURORA 1 results support and underscore our efforts to improve the health outcomes of people living with the devastating impacts of LN," said Robert Huizinga, Ph.D. R.N., Executive Vice President of Research, Aurinia. "It is the culmination of many years of research both within Aurinia and with investigators and patients and we look forward to continuing our research with this important compound, and to sharing longer-term safety and efficacy data from the ongoing AURORA 2 continuation study in the coming months."

    About Lupus Nephritis

    LN is a serious progression of SLE, a chronic and complex autoimmune disease. About 200,000-300,000 people live with SLE in the U.S. and approximately one out of three of these individuals have already developed LN at the time of SLE diagnosis. If poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney, resulting in kidney failure. Black and Asian individuals with SLE are four times more likely to develop LN and individuals with Hispanic ancestry are approximately twice as likely to develop the disease when compared with Caucasian individuals. Black and Hispanic individuals with SLE also tend to develop LN earlier and have poorer outcomes when compared to Caucasian individuals.

    About LUPKYNIS

    LUPKYNIS is the first FDA-approved oral treatment for the treatment of adult patients with active LN. A novel, structurally modified CNI, LUPKYNIS has a dual mechanism of action, acting as an immunosuppressant through inhibition of T-cell activation and cytokine production and promoting podocyte stability in the kidney. The recommended starting dose of LUPKYNIS is three capsules twice daily with no-serum drug monitoring required. Dose modifications can be made based on Aurinia's proprietary personalized eGFR based dosing protocol. Boxed Warning, warnings and precautions for LUPKYNIS are consistent with those of other CNI-immunosuppressive treatments.

    About Aurinia

    Aurinia is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The company recently introduced the first FDA-approved oral therapy dedicated for the treatment of adult patients with active lupus nephritis (LN). Aurinia's head office is in Victoria, British Columbia, its U.S. commercial hub is in Rockville, Maryland, and development efforts are focused globally.

    INDICATION AND IMPORTANT SAFETY INFORMATION

    INDICATIONS

    LUPKYNIS is indicated in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active LN. Limitations of Use: Safety and efficacy of LUPKYNIS have not been established in combination with cyclophosphamide. Use of LUPKYNIS is not recommended in this situation.

    IMPORTANT SAFETY INFORMATION

    BOXED WARNINGS: MALIGNANCIES AND SERIOUS INFECTIONS

    Increased risk for developing malignancies and serious infections with LUPKYNIS or other immunosuppressants that may lead to hospitalization or death.

    CONTRAINDICATIONS: LUPKYNIS is contraindicated in patients taking strong CYP3A4 inhibitors because of the increased risk of acute and/or chronic nephrotoxicity, and in patients who have had a serious/severe hypersensitivity reaction to LUPKYNIS or its excipients.

    WARNINGS AND PRECAUTIONS

    Lymphoma and Other Malignancies: Immunosuppressants, including LUPKYNIS, increase the risk of developing lymphomas and other malignancies, particularly of the skin. The risk appears to be related to increasing doses and duration of immunosuppression rather than to the use of any specific agent.

    Serious Infections: Immunosuppressants, including LUPKYNIS, increase the risk of developing bacterial, viral, fungal, and protozoal infections (including opportunistic infections), which may lead to serious, including fatal, outcomes.

    Nephrotoxicity: LUPKYNIS, like other calcineurin inhibitors (CNIs), may cause acute and/or chronic nephrotoxicity. The risk is increased when CNIs are concomitantly administered with drugs associated with nephrotoxicity.

    Hypertension: Hypertension is a common adverse reaction of LUPKYNIS therapy and may require antihypertensive therapy.

    Neurotoxicity: LUPKYNIS, like other CNIs, may cause a spectrum of neurotoxicities: severe include posterior reversible encephalopathy syndrome (PRES), delirium, seizure, and coma; others include tremor, paresthesia, headache, and changes in mental status and/or motor and sensory functions.

    Hyperkalemia: Hyperkalemia, which may be serious and require treatment, has been reported with CNIs, including LUPKYNIS. Concomitant use of agents associated with hyperkalemia may increase the risk for hyperkalemia.

    QTc Prolongation: LUPKYNIS prolongs the QTc interval in a dose-dependent manner when dosed higher than the recommended lupus nephritis therapeutic dose. The use of LUPKYNIS in combination with other drugs that are known to prolong QTc may result in clinically significant QT prolongation.

    Immunizations: Avoid the use of live attenuated vaccines during treatment with LUPKYNIS. Inactivated vaccines noted to be safe for administration may not be sufficiently immunogenic during treatment with LUPKYNIS.

    Pure Red Cell Aplasia: Cases of pure red cell aplasia (PRCA) have been reported in patients treated with another CNI immunosuppressant. If PRCA is diagnosed, consider discontinuation of LUPKYNIS. Drug-Drug Interactions: Avoid co-administration of LUPKYNIS and strong CYP3A4 inhibitors or with strong or moderate CYP3A4 inducers. Reduce LUPKYNIS dosage when co-administered with moderate CYP3A4 inhibitors. Reduce dosage of certain P-gp substrates with narrow therapeutic windows when co-administered.

    ADVERSE REACTIONS

    The most common adverse reactions (>3%) were glomerular filtration rate decreased, hypertension, diarrhea, headache, anemia, cough, urinary tract infection, abdominal pain upper, dyspepsia, alopecia, renal impairment, abdominal pain, mouth ulceration, fatigue, tremor, acute kidney injury, and decreased appetite.

    SPECIFIC POPULATIONS

    Pregnancy/Lactation: May cause fetal harm. Advise not to breastfeed.

    Renal Impairment: Not recommended in patients with baseline eGFR ≤45 mL/min/1.73 m2 unless benefit exceeds risk. Severe renal impairment: Reduce LUPKYNIS dose.

    Mild and Moderate Hepatic Impairment: Reduce LUPKYNIS dose. Severe hepatic impairment: Avoid LUPKYNIS use.

    Please see Prescribing Information, including Boxed Warning, and Medication Guide for LUPKYNIS.

    Forward-Looking Statements

    Certain statements made in this press release may constitute forward-looking information within the meaning of applicable Canadian securities law and forward-looking statements within the meaning of applicable United States securities law. These forward-looking statements or information include but are not limited to statements or information with respect to: Aurinia's estimates as to the number of patients with SLE in the U.S. and the proportion of those persons who will develop LN; and the proportion of Black and Asian individuals, and individuals with Hispanic ancestry, compared to Caucasian individuals, to develop LN. It is possible that such results or conclusions may change based on further analyses of these data. Words such as "anticipate", "will", "believe", "estimate", "expect", "intend", "target", "plan", "goals", "objectives", "may" and other similar words and expressions, identify forward-looking statements. We have made numerous assumptions about the forward-looking statements and information contained herein, including among other things, assumptions about: the accuracy of the results from our clinical trials; and the accuracy of reported data from third party studies and reports. Even though the management of Aurinia believes that the assumptions made, and the expectations represented by such statements or information are reasonable, there can be no assurance that the forward-looking information will prove to be accurate.

    Forward-looking information by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aurinia to be materially different from any future results, performance or achievements expressed or implied by such forward-looking information. Should one or more of these risks and uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in forward-looking statements or information. Such risks, uncertainties and other factors include, among others, the following difficulties we may experience in completing the commercialization of voclosporin; the market for the LN business may not be as estimated; and the results from our clinical studies and from third party studies and reports may not be accurate. Although we have attempted to identify factors that would cause actual actions, events or results to differ materially from those described in forward-looking statements and information, there may be other factors that cause actual results, performances, achievements or events to not be as anticipated, estimated or intended. Also, many of the factors are beyond our control. There can be no assurance that forward-looking statements or information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, you should not place undue reliance on forward-looking statements or information.

    All forward-looking information contained in this presentation is qualified by this cautionary statement. Additional information related to Aurinia, including a detailed list of the risks and uncertainties affecting Aurinia and its business, can be found in Aurinia's most recent annual report on Form 10-K available by accessing the U.S. Securities and Exchange Commission's Electronic Document Gathering and Retrieval System (EDGAR) website at www.sec.gov/edgar or the Canadian Securities Administrators' System for Electronic Document Analysis and Retrieval (SEDAR) website at www.sedar.com.

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  19. - Quarter highlights include FDA approval, launch and early market penetration of LUPKYNIS™ as the first approved oral therapy for lupus nephritis (LN) -

    - Over 250 patient start forms received by the end of the first quarter -

    - Cash and cash equivalents, and investments of $360.9 million at March 31, 2021 -

    - Conference call to be hosted today at 5:00 p.m. ET -

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) ("Aurinia" or the "Company") today issued its financial results for the first quarter ended March 31, 2021. Amounts, unless specified otherwise, are expressed in U.S. dollars.

    "2021 started with the FDA approval of LUPKYNIS, the first FDA-approved oral treatment for active lupus nephritis – a devastating complication of lupus…

    - Quarter highlights include FDA approval, launch and early market penetration of LUPKYNIS™ as the first approved oral therapy for lupus nephritis (LN) -

    - Over 250 patient start forms received by the end of the first quarter -

    - Cash and cash equivalents, and investments of $360.9 million at March 31, 2021 -

    - Conference call to be hosted today at 5:00 p.m. ET -

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) ("Aurinia" or the "Company") today issued its financial results for the first quarter ended March 31, 2021. Amounts, unless specified otherwise, are expressed in U.S. dollars.

    "2021 started with the FDA approval of LUPKYNIS, the first FDA-approved oral treatment for active lupus nephritis – a devastating complication of lupus," commented Peter Greenleaf, President and Chief Executive Officer of Aurinia. "Our pivotal decision and work to build a world-class commercial infrastructure prior to approval ultimately led to Aurinia being able to make LUPKYNIS immediately available to patients and physicians following approval. Since that time, the Aurinia team has been encouraged by the feedback we are receiving from physicians and patients and our confidence has only grown as we continue to understand the tremendous need and value of LUPKYNIS, and work to accelerate broader adoption across the underserved LN population."

    Recent Highlights

    FDA Approval and Commercial Launch of LUPKYNIS

    On January 22, 2021, the FDA approved LUPKYNIS in combination with a background immunosuppressive therapy regimen to treat adult patients with active LN.

    Commercial Activities

    • Engaged with over 6,000 rheumatologists and nephrologists;
    • Received over 250 patient start forms during the first quarter (covering 48 business days post-FDA approval);
    • Converted nearly 40% of patient start forms to patients on therapy by the end of the first quarter; and
    • Launched LUPKYNIS Patient Marketing Campaign, Focus on the Fight, in April 2021.

    "Since launch, the commercial team has focused on educating their customers on the urgency needed in reducing proteinuria for patients with active LN. With more than 250 patient start forms and 40% of those patients on therapy after the first two months on the market, more than 6,000 clinical interactions, continued gradual expansion of payor coverage, and our Aurinia Alliance patient support program fully operational, the LUPKYNIS trajectory is on track against our internal projections. Furthermore, we anticipate that our market access will continue to improve as the rate of COVID vaccinations in the United States continues to climb and healthcare centers re-open their doors to patients," commented Max Colao, Chief Commercial Officer at Aurinia.

    Upcoming Milestones

    • Anticipate filing a marketing authorization application (MAA) with the European Medicines Agency (EMA) during the first half of 2021 with partner, Otsuka;
    • Abstracts discussing voclosporin accepted for presentation at the Annual European Congress of Rheumatology (EULAR 2021 Congress), June 2 – 5, 2021, and at the Nephrology Virtual Congress (ERA-EDTA 2021), June 5 – 8, 2021;
    • Expect to initiate a study of voclosporin in adolescent patients (VOCAL study) during the second half of 2021; and
    • Anticipate reporting top-line results from the ongoing AURORA-2 continuation study during the first quarter of 2022.

    Financial Liquidity at March 31, 2021

    As of March 31, 2021, Aurinia had cash and cash equivalents and investments of $360.9 million compared to $422.7 million at December 31, 2020. The decrease is primarily related to the commercial infrastructure spend to support the launch of LUPKYNIS in addition to an upfront payment made as part of a collaborative agreement with Lonza to build a dedicated manufacturing facility (also referred to as "monoplant") and one-time payment to a related party upon achievement of specific milestones.

    Net cash used in operating activities was $53.5 million for the quarter ended March 31, 2021 compared to $22.6 million for the quarter ended March 31, 2020. The increase is primarily due to the commercial infrastructure spend to support the launch of LUPKYNIS in addition to a one-time payment to a related party upon achievement of specific milestones. In the prior year, the Company was still in the development phase of LUPKYNIS and as a result, did not incur any material related selling expenses.

    The Company believes that it has sufficient financial resources to fund its current plans, which include funding commercial activities, including our FDA related post approval commitments, manufacturing and packaging of commercial drug supply, conducting our planned research and development (R&D) programs, and operating activities into at least 2023.

    Financial Results for the Quarter Ended March 31, 2021

    For the quarter ended March 31, 2021, Aurinia recorded a net loss of $50.4 million or $0.40 net loss per common share, as compared to a net loss of $25.9 million or $0.23 net loss per common share for the quarter ended March 31, 2020.

    Revenues were $0.9 million and $30 thousand for the quarters ended March 31, 2021 and March 31, 2020, respectively. The increase was the result of the commercial sales of LUPKYNIS, which began in January 2021.

    Cost of sales were $48 thousand and nil for the quarters ended March 31, 2021 and March 31, 2020, respectively. The increase was the result of commercial sales of LUPKYNIS and drug substance. Gross margin for the quarter ended March 31, 2021 was approximately 95%.

    Selling, general and administrative (SG&A) expenses were $39.3 million and $11.1 million for the quarters ended March 31, 2021 and March 31, 2020, respectively. The increase was primarily due to the expansion of the commercial infrastructure, administrative functions and patient assistance programs to support the launch of LUPKYNIS. SG&A share-based compensation expense for the quarter ended March 31, 2021 was $6.6 million.

    R&D expenses were $9.8 million and $13.8 million for the quarters ended March 31, 2021 and March 31, 2020, respectively. The decrease was primarily due to lower Contract Research Organization (CRO) expenses and other third-party clinical trial expenses following the approval of LUPKYNIS, including a reduction in NDA preparation costs, capitalization of supply costs following approval, and termination of the dry eye trial during the fourth quarter of 2020. R&D share-based compensation expense for the quarter ended March 31, 2021 was $1.1 million.

    This press release is intended to be read in conjunction with the Company's unaudited condensed consolidated financial statements and Management's Discussion and Analysis for the quarter ended March 31, 2021 in the Company's Quarterly Report on Form 10-Q, which is accessible on Aurinia's website at www.auriniapharma.com, on SEDAR at www.sedar.com or on EDGAR at www.sec.gov/edgar.

    Conference Call Details

    Aurinia will host a conference call and webcast to discuss the quarter ended March 31, 2021 financial results today, Thursday, May 6, 2021 at 5:00 p.m. ET. The audio webcast can be accessed under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. In order to participate in the conference call, please dial +1-888-506-0062 (toll-free U.S.) or +1-973-528-0011 (international); entry code: 662377. A replay of the conference call will also be available on Aurinia's website approximately two hours after the live call is completed.

    About Lupus Nephritis

    LN is a serious progression of systemic lupus erythematosus (SLE), a chronic and complex autoimmune disease. About 200,000-300,000 people live with SLE in the U.S. and approximately one out of three of these individuals have already developed LN at the time of SLE diagnosis. If poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney, resulting in kidney failure. Black and Asian individuals with SLE are four times more likely to develop LN and individuals with Hispanic ancestry are approximately twice as likely to develop the disease when compared with Caucasian individuals. Black and Hispanic individuals with SLE also tend to develop LN earlier and have poorer outcomes when compared to Caucasian individuals.

    About Aurinia

    Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The Company has introduced LUPKYNIS (voclosporin), the first FDA-approved oral therapy dedicated for the treatment of adult patients with active LN. The Company's head office is in Victoria, British Columbia, its U.S. commercial hub is in Rockville, Maryland, and the Company focuses its development efforts globally.

    Forward-Looking Statements

    Certain statements made in this press release may constitute forward-looking information within the meaning of applicable Canadian securities law and forward-looking statements within the meaning of applicable United States securities law. These forward-looking statements or information include but are not limited to statements or information with respect to: Aurinia's estimates as to the number of patients with SLE in the U.S. and the proportion of those persons who will develop LN; Aurinia's belief that it is on track to meet its internal expectations for the prescribing of LUPKYNIS; Aurinia's belief that it has sufficient financial resources to fund its current plans until 2023; Aurinia's belief that it has a world-class commercial infrastructure; Aurinia's belief that commercial activity will accelerate as the rate of COVID vaccinations in the United States continue to climb and healthcare centers re-open their doors to patients; the planned timing to file an MAA with the EMA; the planned presentation of abstracts covering voclosporin; the timing to initiate the VOCAL study; and the planned timing for reporting top-line results from the ongoing AURORA-2 continuation study. It is possible that such results or conclusions may change based on further analyses of these data. Words such as "anticipate", "will", "believe", "estimate", "expect", "intend", "target", "plan", "goals", "objectives", "may" and other similar words and expressions, identify forward-looking statements. We have made numerous assumptions about the forward-looking statements and information contained herein, including among other things, assumptions about: the accuracy of reported data from third party studies and reports; that Aurinia's intellectual property rights are valid and do not infringe the intellectual property rights of third parties; Aurinia's assumptions relating to the capital required to fund operations into 2023; the assumption that Aurinia's current good relationships with its suppliers, service providers and other third parties will be maintained; assumptions relating to the burn rate of Aurinia's cash for operations; the relationship between COVID vaccinations and patient treatment; and that Aurinia's third party service providers will comply with their contractual obligations. Even though the management of Aurinia believes that the assumptions made, and the expectations represented by such statements or information are reasonable, there can be no assurance that the forward-looking information will prove to be accurate.

    Forward-looking information by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance, or achievements of Aurinia to be materially different from any future results, performance or achievements expressed or implied by such forward-looking information. Should one or more of these risks and uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in forward-looking statements or information. Such risks, uncertainties and other factors include, among others, the following: difficulties Aurinia may experience in completing the commercialization of voclosporin; the market for the LN business may not be as estimated; Aurinia may have to pay unanticipated expenses; Aurinia may not be able to obtain sufficient supply to meet commercial demand for voclosporin in a timely fashion; unknown impact and difficulties imposed by the COVID-19 pandemic on Aurinia's business operations including nonclinical, clinical, regulatory and commercial activities; the results from Aurinia's clinical studies and from third party studies and reports may not be accurate; Aurinia's third party service providers may not, or may not be able to, comply with their obligations under their agreements with Aurinia; and Aurinia's assets or business activities may be subject to disputes that may result in litigation or other legal claims. Although Aurinia has attempted to identify factors that would cause actual actions, events, or results to differ materially from those described in forward-looking statements and information, there may be other factors that cause actual results, performances, achievements, or events to not be as anticipated, estimated or intended. Also, many of the factors are beyond Aurinia's control. There can be no assurance that forward-looking statements or information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, you should not place undue reliance on forward-looking statements or information.

    All forward-looking information contained in this presentation is qualified by this cautionary statement. Additional information related to Aurinia, including a detailed list of the risks and uncertainties affecting Aurinia and its business, can be found in Aurinia's most recent Annual Report on Form 10-K available by accessing the Canadian Securities Administrators' System for Electronic Document Analysis and Retrieval (SEDAR) website at www.sedar.com or the U.S. Securities and Exchange Commission's Electronic Document Gathering and Retrieval System (EDGAR) website at www.sec.gov/edgar, or on Aurinia's website at www.auriniapharma.com.

     

    AURINIA PHARMACEUTICALS INC. AND SUBSIDIARIES

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (in thousands)

     

     

     

    March 31,

    2021

     

    December 31,

    2020

     

     

    (unaudited)

     

     

    ASSETS

     

     

     

     

    Current assets

     

     

     

     

    Cash and cash equivalents

     

    $

    156,591

     

     

    $

    272,350

     

    Short-term investments

     

    191,668

     

     

    125,979

     

    Accounts receivable, net

     

    1,187

     

     

     

    Inventories, net

     

    15,936

     

     

    13,927

     

    Prepaid expenses and other current assets

     

    6,864

     

     

    7,171

     

    Total current assets

     

    372,246

     

     

    419,427

     

     

     

     

     

     

    Non-current assets

     

     

     

     

    Long-term investments

     

    12,603

     

     

    24,380

     

    Other non-current assets

     

    11,856

     

     

    247

     

    Property and equipment, net

     

    4,758

     

     

    4,786

     

    Acquired intellectual property and other intangible assets, net

     

    9,854

     

     

    9,332

     

    Right-of-use assets

     

    5,761

     

     

    5,489

     

    Total assets

     

    417,078

     

     

    463,661

     

     

     

     

     

     

    LIABILITIES

     

     

     

     

    Current liabilities

     

     

     

     

    Accounts payable and accrued liabilities

     

    17,694

     

     

    24,797

     

    Other current liabilities (of which $2,000 and $6,000, due to related party in 2021 and 2020, respectively)

     

    2,382

     

     

    6,412

     

    Operating lease liabilities

     

    1,075

     

     

    788

     

    Total current liabilities

     

    21,151

     

     

    31,997

     

     

     

     

     

     

    Non-current liabilities

     

     

     

     

    Other non-current liabilities

     

    17,893

     

     

    16,295

     

    Operating lease liabilities

     

    7,806

     

     

    7,619

     

    Total liabilities

     

    46,850

     

     

    55,911

     

    SHAREHOLDER'S EQUITY

     

     

     

     

    Common shares - no par value, unlimited shares authorized, 128,121 and 126,725 shares issued and outstanding as at March 31, 2021 and December 31, 2020, respectively

     

    952,673

     

     

    944,328

     

    Additional paid-in capital

     

    43,889

     

     

    39,383

     

    Accumulated other comprehensive loss

     

    (799)

     

     

    (805)

     

    Accumulated deficit

     

    (625,535)

     

     

    (575,156)

     

    Total shareholder's equity

     

    370,228

     

     

    407,750

     

    Total liabilities and shareholders' equity

     

    $

    417,078

     

     

    $

    463,661

     

    AURINIA PHARMACEUTICALS INC. AND SUBSIDIARIES

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (in thousands, except per share data)

     

     

     

    Three months ended

     

     

    March 31,

     

     

    2021

     

    2020

     

     

    unaudited

    Revenue

     

     

     

     

    Product revenue, net

     

    $

    884

     

     

    $

     

    License revenue

     

    30

     

     

    30

     

    Total revenue

     

    914

     

     

    30

     

    Operating expenses:

     

     

     

     

    Cost of sales

     

    48

     

     

     

    Selling, general and administrative

     

    39,282

     

     

    11,053

     

    Research and development

     

    9,833

     

     

    13,835

     

    Amortization of intangible assets

     

    523

     

     

    286

     

    Other expense, net

     

    1,771

     

     

    1,916

     

    Total cost and operating expenses

     

    51,457

     

     

    27,090

     

    Loss from operations

     

    (50,543)

     

     

    (27,060)

     

    Interest income

     

    172

     

     

    890

     

    Net loss before income taxes

     

    (50,371)

     

     

    (26,170)

     

    Income tax expense (benefit)

     

    8

     

     

    (238)

     

    Net loss

     

    $

    (50,379)

     

     

    $

    (25,932)

     

    Basic and diluted loss per share

     

    $

    (0.40)

     

     

    $

    (0.23)

     

    Weighted-average common shares outstanding used in computation of basic and diluted loss per share

     

    127,401

     

     

    112,209

     

     

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  20. Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) (the "Company") today announced that it will release its first quarter 2021 financial results on Thursday, May 6, 2021, after the markets close. Aurinia's management team will also host a conference call at 5:00 p.m. EDT to discuss the Company's financial results and to provide a general business update.

    The conference call and webcast is scheduled for May 6, 2021 at 5:00 p.m. ET. In order to participate in the conference call, please dial +1-888-506-0062 (toll-free U.S.) or +1-973-528-0011 (international); entry code: 662377. The audio webcast can be accessed under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast…

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) (the "Company") today announced that it will release its first quarter 2021 financial results on Thursday, May 6, 2021, after the markets close. Aurinia's management team will also host a conference call at 5:00 p.m. EDT to discuss the Company's financial results and to provide a general business update.

    The conference call and webcast is scheduled for May 6, 2021 at 5:00 p.m. ET. In order to participate in the conference call, please dial +1-888-506-0062 (toll-free U.S.) or +1-973-528-0011 (international); entry code: 662377. The audio webcast can be accessed under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will also be available on Aurinia's website approximately two hours after the live call is completed.

    ABOUT AURINIA

    Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The Company has introduced LUPKYNIS™ (voclosporin), the first FDA-approved oral therapy dedicated for the treatment of adult patients with active lupus nephritis (LN). The Company's head office is in Victoria, British Columbia, its U.S. commercial hub is in Rockville, Maryland, and the Company focuses its development efforts globally.

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  21. Additional efficacy data from pooled analysis of AURA-LV and AURORA 1 pivotal trials demonstrate potential to improve renal response regardless of disease progression at diagnosis

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) (Aurinia or the Company) today presented additional efficacy data from the AURA-LV and AURORA 1 pivotal trials of LUPKYNIS™ (voclosporin) in lupus nephritis (LN). The data were shared at the National Kidney Foundation (NKF) 2021 Spring Clinical Meetings by Anca D. Askanase, M.D., M.P.H., Founder and Director of Columbia University Irving Medical Center's Lupus Center and the Director of Rheumatology Clinical Trials.

    Pooled data from the AURA-LV and AURORA 1 study demonstrate that LUPKYNIS, in combination with…

    Additional efficacy data from pooled analysis of AURA-LV and AURORA 1 pivotal trials demonstrate potential to improve renal response regardless of disease progression at diagnosis

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) (Aurinia or the Company) today presented additional efficacy data from the AURA-LV and AURORA 1 pivotal trials of LUPKYNIS™ (voclosporin) in lupus nephritis (LN). The data were shared at the National Kidney Foundation (NKF) 2021 Spring Clinical Meetings by Anca D. Askanase, M.D., M.P.H., Founder and Director of Columbia University Irving Medical Center's Lupus Center and the Director of Rheumatology Clinical Trials.

    Pooled data from the AURA-LV and AURORA 1 study demonstrate that LUPKYNIS, in combination with mycophenolate mofetil (MMF) and low-dose corticosteroids, led to treatment benefits across biopsy class subgroups compared with treatment with MMF and low-dose corticosteroids alone (placebo). MMF and low-dose corticosteroids are considered standard of care (SoC) for the treatment of LN. On January 22, 2021, the U.S. Food and Drug Administration (FDA) approved LUPKYNIS in combination with a background immunosuppressive therapy regimen to treat adult patients with active LN.

    "People with LN can sometimes have a delay in diagnosis and often incomplete responses to treatment, increasing their likelihood of kidney damage and other disease complications. These data support LUPKYNIS' potential as an important tool to control LN regardless of the disease classification," said Anca D. Askanase, M.D., MPH, Founder and Director of Columbia University Irving Medical Center's Lupus Center and the Director of Rheumatology Clinical Trials.

    Data from 532 patients from the AURA-LV and AURORA 1 studies were integrated in a post-hoc analysis of complete renal response (CRR) by LN biopsy class. The AURA-LV and AURORA 1 studies were similar in design and patient populations. The data from both studies for subjects treated with the recommended LUPKYNIS dose of 23.7 mg twice daily (AURA-LV n=89, AURORA 1 n=179) or with matching placebo (AURA-LV n=88, AURORA 1 n= 178) were pooled for the integrated analysis. The odds ratios (OR) for CRR for LUPKYNIS versus placebo were 4.26 for pure Class III (p=0.0054), 2.59 for pure Class IV (p=0.0005), 1.5 for pure Class V (p=0.4090), and 2.68 for mixed Class III/IV and V patients (p=0.0166). Achieving an OR greater than 1 indicates that LUPKYNIS is favored over placebo. Pure Class V was the least common, with 75 patients in both studies. The clinical trials were not powered to detect a significant difference between the two treatment arms by biopsy class.

    About Lupus Nephritis

    LN is a serious manifestation of SLE, a chronic and complex autoimmune disease. About 200,000-300,000 people live with SLE in the U.S. and approximately one out of three of these individuals develop LN. If poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney, resulting in kidney failure. Black and Asian individuals with SLE are four times more likely to develop LN and individuals of Hispanic ancestry are approximately twice as likely to develop the disease when compared with Caucasian individuals. Black and Hispanic individuals with SLE also tend to develop LN earlier and have poorer outcomes when compared to Caucasian individuals.

    About LUPKYNIS

    LUPKYNIS is the first FDA-approved oral treatment for the treatment of adult patients with active LN. A novel, structurally modified calcineurin inhibitor (CNI), LUPKYNIS has a dual mechanism of action, acting as an immunosuppressant through inhibition of T-cell activation and cytokine production and promoting podocyte stability in the kidney. The recommended starting dose of LUPKYNIS is three capsules twice daily with no requirement for serum drug monitoring. Dose modifications can be made based on Aurinia's proprietary personalized eGFR based dosing protocol. Boxed Warning, warnings and precautions for LUPKYNIS are consistent with those of other CNI-immunosuppressive treatments.

    About Aurinia

    Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The Company's head office is in Victoria, British Columbia, its U.S. commercial hub is in Rockville, Maryland, and the Company focuses its development efforts globally.

    INDICATION AND IMPORTANT SAFETY INFORMATION

    INDICATIONS

    LUPKYNIS is indicated in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active LN. Limitations of Use: Safety and efficacy of LUPKYNIS have not been established in combination with cyclophosphamide. Use of LUPKYNIS is not recommended in this situation.

    IMPORTANT SAFETY INFORMATION

    BOXED WARNINGS: MALIGNANCIES AND SERIOUS INFECTIONS

    Increased risk for developing malignancies and serious infections with LUPKYNIS or other immunosuppressants that may lead to hospitalization or death.

    CONTRAINDICATIONS: LUPKYNIS is contraindicated in patients taking strong CYP3A4 inhibitors because of the increased risk of acute and/or chronic nephrotoxicity, and in patients who have had a serious/severe hypersensitivity reaction to LUPKYNIS or its excipients.

    WARNINGS AND PRECAUTIONS

    Lymphoma and Other Malignancies: Immunosuppressants, including LUPKYNIS, increase the risk of developing lymphomas and other malignancies, particularly of the skin. The risk appears to be related to increasing doses and duration of immunosuppression rather than to the use of any specific agent.

    Serious Infections: Immunosuppressants, including LUPKYNIS, increase the risk of developing bacterial, viral, fungal, and protozoal infections (including opportunistic infections), which may lead to serious, including fatal, outcomes.

    Nephrotoxicity: LUPKYNIS, like other CNIs, may cause acute and/or chronic nephrotoxicity. The risk is increased when CNIs are concomitantly administered with drugs associated with nephrotoxicity.

    Hypertension: Hypertension is a common adverse reaction of LUPKYNIS therapy and may require antihypertensive therapy.

    Neurotoxicity: LUPKYNIS, like other CNIs, may cause a spectrum of neurotoxicities: severe include posterior reversible encephalopathy syndrome (PRES), delirium, seizure, and coma; others include tremor, paresthesia, headache, and changes in mental status and/or motor and sensory functions.

    Hyperkalemia: Hyperkalemia, which may be serious and require treatment, has been reported with CNIs, including LUPKYNIS. Concomitant use of agents associated with hyperkalemia may increase the risk for hyperkalemia.

    QTc Prolongation: LUPKYNIS prolongs the QTc interval in a dose-dependent manner when dosed higher than the recommended lupus nephritis therapeutic dose. The use of LUPKYNIS in combination with other drugs that are known to prolong QTc may result in clinically significant QT prolongation.

    Immunizations: Avoid the use of live attenuated vaccines during treatment with LUPKYNIS. Inactivated vaccines noted to be safe for administration may not be sufficiently immunogenic during treatment with LUPKYNIS.

    Pure Red Cell Aplasia: Cases of pure red cell aplasia (PRCA) have been reported in patients treated with another CNI immunosuppressant. If PRCA is diagnosed, consider discontinuation of LUPKYNIS.

    Drug-Drug Interactions: Avoid co-administration of LUPKYNIS and strong CYP3A4 inhibitors or with strong or moderate CYP3A4 inducers. Reduce LUPKYNIS dosage when co-administered with moderate CYP3A4 inhibitors. Reduce dosage of certain P-gp substrates with narrow therapeutic windows when co-administered.

    ADVERSE REACTIONS

    The most common adverse reactions (>3%) were glomerular filtration rate decreased, hypertension, diarrhea, headache, anemia, cough, urinary tract infection, abdominal pain upper, dyspepsia, alopecia, renal impairment, abdominal pain, mouth ulceration, fatigue, tremor, acute kidney injury, and decreased appetite.

    SPECIFIC POPULATIONS

    Pregnancy/Lactation: May cause fetal harm. Advise not to breastfeed.

    Renal Impairment: Not recommended in patients with baseline eGFR ≤45 mL/min/1.73 m2 unless benefit exceeds risk. Severe renal impairment: Reduce LUPKYNIS dose.

    Mild and Moderate Hepatic Impairment: Reduce LUPKYNIS dose. Severe hepatic impairment: Avoid LUPKYNIS use.

    Please see Prescribing Information, including Boxed Warning, and Medication Guide for LUPKYNIS.

    Forward-Looking Statements

    Certain statements made in this press release may constitute forward-looking information within the meaning of applicable Canadian securities law and forward-looking statements within the meaning of applicable United States securities law. These forward-looking statements or information include but are not limited to statements or information with respect to: LUPKYNIS being an important tool to control LN regardless of the disease classification; the integrated results from the AURA-LV and AURORA 1 studies; Aurinia's estimates as to the number of patients with SLE in the U.S. and the proportion of those persons who will develop LN; the estimated proportion of Black and Asian individuals, and individuals with Hispanic ancestry, compared to Caucasian individuals, to develop LN; Aurinia enhancing access with a variety of patient services and healthcare engagement initiatives. It is possible that such results or conclusions may change based on further analyses of these data. Words such as "anticipate", "will", "believe", "estimate", "expect", "intend", "target", "plan", "goals", "objectives", "may" and other similar words and expressions, identify forward-looking statements. We have made numerous assumptions about the forward-looking statements and information contained herein, including among other things, assumptions about: the accuracy of the results from our clinical trials; and the accuracy of reported data from third party studies and reports. Even though the management of Aurinia believes that the assumptions made, and the expectations represented by such statements or information are reasonable, there can be no assurance that the forward-looking information will prove to be accurate.

    Forward-looking information by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aurinia to be materially different from any future results, performance or achievements expressed or implied by such forward-looking information. Should one or more of these risks and uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in forward-looking statements or information. Such risks, uncertainties and other factors include, among others, the results from our clinical studies and from third party studies and reports may not be accurate. Although we have attempted to identify factors that would cause actual actions, events or results to differ materially from those described in forward-looking statements and information, there may be other factors that cause actual results, performances, achievements or events to not be as anticipated, estimated or intended. Also, many of the factors are beyond our control. There can be no assurance that forward-looking statements or information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, you should not place undue reliance on forward-looking statements or information.

    All forward-looking information contained in this presentation is qualified by this cautionary statement. Additional information related to Aurinia, including a detailed list of the risks and uncertainties affecting Aurinia and its business, can be found in Aurinia's most recent annual report on Form 10-K available by accessing the U.S. Securities and Exchange Commission's Electronic Document Gathering and Retrieval System (EDGAR) website at www.sec.gov/edgar or the Canadian Securities Administrators' System for Electronic Document Analysis and Retrieval (SEDAR) website at www.sedar.com.

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  22. Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) (Aurinia or the Company) today announced a favorable assessment regarding the cost-effectiveness and value of LUPKYNIS™ (voclosporin), based on an independent analysis issued by the Institute for Clinical and Economic Review (ICER) in a revised Evidence Report issued on March 12, 2021. The report finds that LUPKYNIS represents an important new treatment option for patients living with lupus nephritis (LN) and at the estimated net price, determined the therapy to be priced in alignment with ICER's recommended health-benefit price benchmark ranges.

    LN is a serious progression of systemic lupus erythematosus (SLE) that can lead to permanent and irreversible kidney damage, if poorly controlled…

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) (Aurinia or the Company) today announced a favorable assessment regarding the cost-effectiveness and value of LUPKYNIS™ (voclosporin), based on an independent analysis issued by the Institute for Clinical and Economic Review (ICER) in a revised Evidence Report issued on March 12, 2021. The report finds that LUPKYNIS represents an important new treatment option for patients living with lupus nephritis (LN) and at the estimated net price, determined the therapy to be priced in alignment with ICER's recommended health-benefit price benchmark ranges.

    LN is a serious progression of systemic lupus erythematosus (SLE) that can lead to permanent and irreversible kidney damage, if poorly controlled. Medical expenses are four times higher for people with LN when compared to people with SLE alone and black people with SLE are four times more likely to develop the condition. The ICER report determined LUPKYNIS to be more cost-effective across several sub-groups of LN patient populations, including black patients, compared to the general population, which ICER notes could have the potential to reduce historic disparities.

    The ICER report also reiterated that voclosporin added to standard therapy nearly doubled the complete response (CR) and markedly increased the partial response (PR) of patients at one year compared with standard therapy alone. In the AURA-LV Phase 2 and AURORA Phase 3 clinical trials, when added to the standard of Care (SoC), LUPKYNIS nearly doubled the likelihood of achieving CR and reduced the median time to urine protein/creatinine ratio (UPCR) by 50 percent, when compared to treatment with the SoC alone.

    "We are encouraged by ICER's recognition of the burden of lupus nephritis, particularly its impact on the racial disparities that we know exist. ICER's assessment of LUPKYNIS is consistent with the real-world view of LUPKYNIS' value we are hearing during our positive interactions with both physicians and payers during the first two months since our launch," said Peter Greenleaf, Chief Executive Officer of Aurinia Pharmaceuticals. "As we observed in our clinical studies, patients responded to voclosporin nearly two times faster than the current standard of care within one year and we are confident that with this time-to-response and efficacy data, LUPKYNIS provides significant therapeutic and economic value for patients and the healthcare system."

    ICER is an independent non-profit research organization that evaluates the evidence on the clinical and economic value of prescription drugs, medical tests, devices, and health system delivery innovations. The report will next be evaluated by the ICER Council before the organization issues its final Evidence Report.

    About Lupus Nephritis

    LN is a serious progression of SLE, a chronic and complex autoimmune disease. About 200,000-300,000 people live with SLE in the U.S. and approximately one out of three of these individuals have already developed LN at the time of SLE diagnosis. If poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney, resulting in kidney failure. Black and Asian individuals with SLE are four times more likely to develop LN and individuals with Hispanic ancestry are approximately twice as likely to develop the disease when compared with Caucasian individuals. Black and Hispanic individuals with SLE also tend to develop LN earlier and have poorer outcomes when compared to Caucasian individuals.

    About LUPKYNIS

    LUPKYNIS is the first FDA-approved oral treatment for the treatment of adult patients with active lupus nephritis. A novel, structurally modified CNI, LUPKYNIS has a dual mechanism of action, acting as an immunosuppressant through inhibition of T-cell activation and cytokine production and promoting podocyte stability in the kidney. The recommended starting dose of LUPKYNIS is three capsules twice daily with no-serum drug monitoring required. Dose modifications can be made based on Aurinia's proprietary personalized eGFR based dosing protocol. Boxed Warning, warnings and precautions for LUPKYNIS are consistent with those of other CNI-immunosuppressive treatments.

    About Aurinia

    Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The Company's head office is in Victoria, British Columbia, its U.S. commercial hub is in Rockville, Maryland, and the Company focuses its development efforts globally.

    INDICATION AND IMPORTANT SAFETY INFORMATION

    INDICATIONS

    LUPKYNIS is indicated in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active LN. Limitations of Use: Safety and efficacy of LUPKYNIS have not been established in combination with cyclophosphamide. Use of LUPKYNIS is not recommended in this situation.

    IMPORTANT SAFETY INFORMATION

    BOXED WARNINGS: MALIGNANCIES AND SERIOUS INFECTIONS

    Increased risk for developing malignancies and serious infections with LUPKYNIS or other immunosuppressants that may lead to hospitalization or death.

    CONTRAINDICATIONS: LUPKYNIS is contraindicated in patients taking strong CYP3A4 inhibitors because of the increased risk of acute and/or chronic nephrotoxicity, and in patients who have had a serious/severe hypersensitivity reaction to LUPKYNIS or its excipients.

    WARNINGS AND PRECAUTIONS

    Lymphoma and Other Malignancies: Immunosuppressants, including LUPKYNIS, increase the risk of developing lymphomas and other malignancies, particularly of the skin. The risk appears to be related to increasing doses and duration of immunosuppression rather than to the use of any specific agent.

    Serious Infections: Immunosuppressants, including LUPKYNIS, increase the risk of developing bacterial, viral, fungal, and protozoal infections (including opportunistic infections), which may lead to serious, including fatal, outcomes.

    Nephrotoxicity: LUPKYNIS, like other calcineurin inhibitors (CNIs), may cause acute and/or chronic nephrotoxicity. The risk is increased when CNIs are concomitantly administered with drugs associated with nephrotoxicity.

    Hypertension: Hypertension is a common adverse reaction of LUPKYNIS therapy and may require antihypertensive therapy.

    Neurotoxicity: LUPKYNIS, like other CNIs, may cause a spectrum of neurotoxicities: severe include posterior reversible encephalopathy syndrome (PRES), delirium, seizure, and coma; others include tremor, paresthesia, headache, and changes in mental status and/or motor and sensory functions.

    Hyperkalemia: Hyperkalemia, which may be serious and require treatment, has been reported with CNIs, including LUPKYNIS. Concomitant use of agents associated with hyperkalemia may increase the risk for hyperkalemia.

    QTc Prolongation: LUPKYNIS prolongs the QTc interval in a dose-dependent manner when dosed higher than the recommended lupus nephritis therapeutic dose. The use of LUPKYNIS in combination with other drugs that are known to prolong QTc may result in clinically significant QT prolongation.

    Immunizations: Avoid the use of live attenuated vaccines during treatment with LUPKYNIS. Inactivated vaccines noted to be safe for administration may not be sufficiently immunogenic during treatment with LUPKYNIS.

    Pure Red Cell Aplasia: Cases of pure red cell aplasia (PRCA) have been reported in patients treated with another CNI immunosuppressant. If PRCA is diagnosed, consider discontinuation of LUPKYNIS. Drug-Drug Interactions: Avoid co-administration of LUPKYNIS and strong CYP3A4 inhibitors or with strong or moderate CYP3A4 inducers. Reduce LUPKYNIS dosage when co-administered with moderate CYP3A4 inhibitors. Reduce dosage of certain P-gp substrates with narrow therapeutic windows when co-administered.

    ADVERSE REACTIONS

    The most common adverse reactions (>3%) were glomerular filtration rate decreased, hypertension, diarrhea, headache, anemia, cough, urinary tract infection, abdominal pain upper, dyspepsia, alopecia, renal impairment, abdominal pain, mouth ulceration, fatigue, tremor, acute kidney injury, and decreased appetite.

    SPECIFIC POPULATIONS

    Pregnancy/Lactation: May cause fetal harm. Advise not to breastfeed.

    Renal Impairment: Not recommended in patients with baseline eGFR ≤45 mL/min/1.73 m2 unless benefit exceeds risk. Severe renal impairment: Reduce LUPKYNIS dose.

    Mild and Moderate Hepatic Impairment: Reduce LUPKYNIS dose. Severe hepatic impairment: Avoid LUPKYNIS use.

    Please see Prescribing Information, including Boxed Warning, and Medication Guide for LUPKYNIS.

    Forward-Looking Statements

    Certain statements made in this press release may constitute forward-looking information within the meaning of applicable Canadian securities law and forward-looking statements within the meaning of applicable United States securities law. These forward-looking statements or information include but are not limited to statements or information with respect to: Aurinia's estimates as to the number of patients with SLE in the U.S. and the proportion of those persons who will develop LN; the estimated proportion of Black and Asian individuals, and individuals with Hispanic ancestry, compared to Caucasian individuals, to develop LN; Aurinia enhancing access with a variety of patient services and healthcare engagement initiatives. It is possible that such results or conclusions may change based on further analyses of these data. Words such as "anticipate", "will", "believe", "estimate", "expect", "intend", "target", "plan", "goals", "objectives", "may" and other similar words and expressions, identify forward-looking statements. We have made numerous assumptions about the forward-looking statements and information contained herein, including among other things, assumptions about: the accuracy of the results from our clinical trials; and the accuracy of reported data from third party studies and reports. Even though the management of Aurinia believes that the assumptions made, and the expectations represented by such statements or information are reasonable, there can be no assurance that the forward-looking information will prove to be accurate.

    Forward-looking information by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aurinia to be materially different from any future results, performance or achievements expressed or implied by such forward-looking information. Should one or more of these risks and uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in forward-looking statements or information. Such risks, uncertainties and other factors include, among others, the following difficulties: we may experience in completing the commercialization of voclosporin; the market for the LN business may not be as estimated; and the results from our clinical studies and from third party studies and reports may not be accurate. Although we have attempted to identify factors that would cause actual actions, events or results to differ materially from those described in forward-looking statements and information, there may be other factors that cause actual results, performances, achievements or events to not be as anticipated, estimated or intended. Also, many of the factors are beyond our control. There can be no assurance that forward-looking statements or information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, you should not place undue reliance on forward-looking statements or information.

    All forward-looking information contained in this presentation is qualified by this cautionary statement. Additional information related to Aurinia, including a detailed list of the risks and uncertainties affecting Aurinia and its business, can be found in Aurinia's most recent annual report on Form 10-K available by accessing the U.S. Securities and Exchange Commission's Electronic Document Gathering and Retrieval System (EDGAR) website at www.sec.gov/edgar or the Canadian Securities Administrators' System for Electronic Document Analysis and Retrieval (SEDAR) website at www.sedar.com.

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  23. Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) (the "Company") today announced that members of the executive management team will participate in multiple upcoming investor conferences including the:

    • Cowen 41st Annual virtual Healthcare Conference fireside chat on Thursday, March 4, 2021 at 2:10 p.m. ET;
    • H.C. Wainwright Global Life Sciences Conference fireside chat available on Tuesday, March 9, 2021 at 7:00 a.m. ET; and
    • Oppenheimer's 31st Annual Healthcare Conference presentation on Wednesday, March 17, 2021 at 10:40 a.m. ET.

    In order to participate in the audio webcast, interested parties can access the live webcast under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A…

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) (the "Company") today announced that members of the executive management team will participate in multiple upcoming investor conferences including the:

    • Cowen 41st Annual virtual Healthcare Conference fireside chat on Thursday, March 4, 2021 at 2:10 p.m. ET;
    • H.C. Wainwright Global Life Sciences Conference fireside chat available on Tuesday, March 9, 2021 at 7:00 a.m. ET; and
    • Oppenheimer's 31st Annual Healthcare Conference presentation on Wednesday, March 17, 2021 at 10:40 a.m. ET.

    In order to participate in the audio webcast, interested parties can access the live webcast under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will be available on Aurinia's website.

    ABOUT AURINIA

    Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The Company has introduced LUPKYNIS™ (voclosporin), the first FDA-approved oral therapy dedicated for the treatment of adult patients with active lupus nephritis (LN). The Company's head office is in Victoria, British Columbia, its U.S. commercial hub is in Rockville, Maryland, and the Company focuses its development efforts globally.

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  24. - LUPKYNISTM is the first FDA-approved oral therapy for lupus nephritis (LN), a condition that causes irreversible kidney damage and increases the risk of kidney failure, cardiac events, and death -

    - Cash, cash equivalents, and investments of $423 million at December 31, 2020 –

    - Conference call to be hosted today at 4:30 p.m. ET -

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) ("Aurinia" or the "Company") today issued its financial results for the fourth quarter and year ended December 31, 2020. Amounts, unless specified otherwise, are expressed in U.S. dollars.

    "Over the past year, Aurinia matured into a fully-integrated biopharmaceutical company with capabilities spanning R&D, clinical, regulatory, CMC, and commercial. The recent…

    - LUPKYNISTM is the first FDA-approved oral therapy for lupus nephritis (LN), a condition that causes irreversible kidney damage and increases the risk of kidney failure, cardiac events, and death -

    - Cash, cash equivalents, and investments of $423 million at December 31, 2020 –

    - Conference call to be hosted today at 4:30 p.m. ET -

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) ("Aurinia" or the "Company") today issued its financial results for the fourth quarter and year ended December 31, 2020. Amounts, unless specified otherwise, are expressed in U.S. dollars.

    "Over the past year, Aurinia matured into a fully-integrated biopharmaceutical company with capabilities spanning R&D, clinical, regulatory, CMC, and commercial. The recent FDA approval and immediate launch of LUPKYNIS underscores the exemplary performance and expertise of the Aurinia team," commented Peter Greenleaf, President and Chief Executive Officer of Aurinia. "During 2020, we made calculated investments following the positive AURORA clinical trial results by building out a world-class commercial team, signing a major ex-US partnership with Otsuka, and ensuring we can meet future market demand for LUPKYNIS by securing our supply chain by expanding our manufacturing agreement with Lonza. After just 30 days, we are pleased by the uptake of LUPKYNIS by the healthcare community and believe we are on track to meet our internal expectations."

    "Launching LUPKYNIS within hours of our approval allows us to focus on getting LN patients who need intervention onto therapy as soon as possible," said Max Colao, Chief Commercial Officer at Aurinia. "We look forward to translating years of innovation and development work, and our early preparation and planning for launch, into commercial success for LUPKYNIS."

    Recent Highlights

    FDA Approval and Commercial Launch of LUPKYNISTM

    On January 22, 2021, the FDA approved LUPKYNIS in combination with a background immunosuppressive therapy regimen to treat adult patients with active LN. LUPKYNIS was approved by the FDA under Priority Review and was previously granted Fast Track designation from the Agency in 2016.

    Collaboration and Licensing Agreement with Otsuka Pharmaceutical Co., Ltd.

    On December 17, 2020, Aurinia announced it had entered into a collaboration and licensing agreement with Otsuka Pharmaceutical Co., Ltd., for the development and commercialization of oral LUPKYNIS for the treatment of LN in the European Union (EU), Japan, as well as the United Kingdom, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein, and Ukraine.

    As part of the agreement, Aurinia received an upfront cash payment of $50 million for the license agreement, and has the potential to receive up to an additional $50 million in regulatory milestones. Aurinia will receive tiered royalties on future sales ranging from 10 to 20 percent on net sales upon commercialization, along with additional milestone payments based on the attainment of certain annual sales by Otsuka. In addition, Aurinia will provide LUPKYNIS to Otsuka via a supply agreement under a cost plus arrangement.

    Agreement for Dedicated LUPKYNIS Manufacturing Capacity

    On December 15, 2020, Aurinia entered into a collaborative agreement with Lonza Ltd. (Lonza) to build a dedicated manufacturing capacity within Lonza's existing small molecule facility in Visp, Switzerland. The dedicated facility (also referred to as "monoplant") will be equipped with state-of-the-art manufacturing equipment to provide cost and production efficiency for the manufacture of LUPKYNIS, while expanding existing capacity and providing supply security to meet future commercial demand. Upon completion of the monoplant, Aurinia will have the right to maintain exclusive use of the monoplant by paying a quarterly fixed facility fee. The first capital expenditure payment was made in February 2021.

    Financial Liquidity at December 31, 2020

    As of December 31, 2020, Aurinia had cash, cash equivalents and investments of $423 million compared to $306 million at December 31, 2019. Net cash used in operating activities was $69.9 million for the year ended December 31, 2020 compared to $63.6 million for the year ended December 31, 2019.

    The Company believes that it has sufficient financial resources to fund its current plans, which include funding commercial launch activities, manufacturing and packaging of commercial drug supply, conducting our planned R&D programs, and operating activities into at least 2023.

    Financial Results for the Year Ended December 31, 2020

    For the year ended December 31, 2020, Aurinia recorded a consolidated net loss of $102.7 million or $0.87 per common share.

    Revenues were $50.1 million and $0.3 million for the years ended December 31, 2020 and 2019, respectively. The increase of $49.8 million in 2020 was due to the upfront license payment received from Otsuka of $50 million, recorded as licensing revenue in the fourth quarter of 2020.

    Research and development (R&D) expenses decreased to $50.3 million for the year ended December 31, 2020 compared to $52.9 million for the year ended December 31, 2019. The primary driver for the decrease of $2.5 million in R&D spend in 2020 was a decrease in drug manufacturing and supply costs, lower Contract Research Organization (CRO) expenses and other third party clinical trial expenses, partially offset by an increase in regulatory related costs as Aurinia prepared for FDA approval.

    Corporate, administration and business development expenses increased to $96 million for the year ended December 31, 2020 compared to $22.3 million for the year ended December 31, 2019. The primary driver for the increase of $73.6 million was the build out of commercial infrastructure in advance of approval, which included an increase in salaries and employee benefits, share based compensation expense and professional fees incurred during the year.

    Financial Results for the Fourth Quarter Ended December 31, 2020

    For the three months ended December 31, 2020, Aurinia recorded a consolidated net loss of $8.1 million or $0.05 per common share.

    Revenues were $50 million and $0.03 million for the three months ended December 31, 2020 and 2019, respectively. The increase of $50 million in 2020 was due to the upfront payment from Otsuka of $50 million recorded as licensing revenue.

    R&D expenses decreased to $13.2 million for the three months ended December 31, 2020 compared to $13.3 million for the three months ended December 31, 2019. The primary drivers for the slight decrease in R&D spend in 2020 was a decrease in drug manufacturing and supply costs, lower CRO expenses and other third party clinical trial expenses, partially offset by an increase in regulatory related costs as Aurinia prepared for FDA approval.

    Corporate, administration and business development expenses increased to $38.8 million for the three months ended December 31, 2020 compared to $7.3 million for the three months ended December 31, 2019. The primary driver for the increase of $31.5 million in 2020 was the build out of commercial infrastructure in advance of approval, which included an increase in salaries and employee benefits, share based compensation expense and professional fees incurred during the quarter.

    This press release is intended to be read in conjunction with the Company's audited financial statements and the Management's Discussion and Analysis for the year ended December 31, 2020 in the Company's Annual Report on Form 10-K, which is accessible on Aurinia's website at www.auriniapharma.com, on SEDAR at www.sedar.com or on EDGAR at www.sec.gov/edgar.

    Aurinia will host a conference call and webcast to discuss the fourth quarter and year ended December 31, 2020 financial results today, Wednesday, February 24, 2020 at 4:30 p.m. ET. This event can be accessed on the investor section of the Aurinia website at www.auriniapharma.com.

    About Lupus Nephritis

    LN is a serious progression of systemic lupus erythematosus (SLE), a chronic and complex autoimmune disease. About 200,000-300,000 people live with SLE in the U.S. and approximately one out of three of these individuals have already developed LN at the time of SLE diagnosis. If poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney, resulting in kidney failure. Black and Asian individuals with SLE are four times more likely to develop LN and individuals with Hispanic ancestry are approximately twice as likely to develop the disease when compared with Caucasian individuals. Black and Hispanic individuals with SLE also tend to develop LN earlier and have poorer outcomes when compared to Caucasian individuals.

    About Aurinia

    Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The Company has introduced LUPKYNIS (voclosporin), the first FDA-approved oral therapy dedicated for the treatment of adult patients with active LN. The Company's head office is in Victoria, British Columbia, its U.S. commercial hub is in Rockville, Maryland, and the Company focuses its development efforts globally.

    Forward-Looking Statements

    Certain statements made in this press release may constitute forward-looking information within the meaning of applicable Canadian securities law and forward-looking statements within the meaning of applicable United States securities law. These forward-looking statements or information include but are not limited to statements or information with respect to: Aurinia's estimates as to the number of patients with SLE in the U.S. and the proportion of those persons who will develop LN; Aurinia's belief that it is on track to meet its internal expectations for the prescribing of LUPKYNIS; Aurinia will receive certain payments (including royalties and milestones) from its agreement with Otsuka; that operational qualification of the monoplant facility is expected in 2023; Aurinia's belief that it has sufficient financial resources to fund its current plans until 2023. It is possible that such results or conclusions may change based on further analyses of these data. Words such as "anticipate", "will", "believe", "estimate", "expect", "intend", "target", "plan", "goals", "objectives", "may" and other similar words and expressions, identify forward-looking statements. We have made numerous assumptions about the forward-looking statements and information contained herein, including among other things, assumptions about: the accuracy of reported data from third party studies and reports; that Aurinia's intellectual property rights are valid and do not infringe the intellectual property rights of third parties; Aurinia's assumptions relating to the capital required to fund operations into 2023; the assumption that Aurinia's current good relationships with its suppliers, service providers and other third parties will be maintained; assumptions relating to the burn rate of Aurinia's cash for operations; that Aurinia's third party service providers will comply with their contractual obligations. Even though the management of Aurinia believes that the assumptions made, and the expectations represented by such statements or information are reasonable, there can be no assurance that the forward-looking information will prove to be accurate.

    Forward-looking information by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance, or achievements of Aurinia to be materially different from any future results, performance or achievements expressed or implied by such forward-looking information. Should one or more of these risks and uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in forward-looking statements or information. Such risks, uncertainties and other factors include, among others, the following: difficulties Aurinia may experience in completing the commercialization of voclosporin; the market for the LN business may not be as estimated; Aurinia may have to pay unanticipated expenses; Aurinia may not be able to obtain sufficient supply to meet commercial demand for voclosporin in a timely fashion; unknown impact and difficulties imposed by the COVID-19 pandemic on Aurinia's business operations including nonclinical, clinical, regulatory and commercial activities; the results from Aurinia's clinical studies and from third party studies and reports may not be accurate; Aurinia's third party service providers may not, or may not be able to, comply with their obligations under their agreements with Aurinia; and Aurinia's assets or business activities may be subject to disputes that may result in litigation or other legal claims. Although Aurinia has attempted to identify factors that would cause actual actions, events, or results to differ materially from those described in forward-looking statements and information, there may be other factors that cause actual results, performances, achievements, or events to not be as anticipated, estimated or intended. Also, many of the factors are beyond Aurinia's control. There can be no assurance that forward-looking statements or information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, you should not place undue reliance on forward-looking statements or information.

    All forward-looking information contained in this presentation is qualified by this cautionary statement. Additional information related to Aurinia, including a detailed list of the risks and uncertainties affecting Aurinia and its business, can be found in Aurinia's most recent Annual Report on Form 10-K available by accessing the Canadian Securities Administrators' System for Electronic Document Analysis and Retrieval (SEDAR) website at www.sedar.com or the U.S. Securities and Exchange Commission's Electronic Document Gathering and Retrieval System (EDGAR) website at www.sec.gov/edgar, or on Aurinia's website at www.auriniapharma.com.

     

    Aurinia Pharmaceuticals Inc.

    Condensed Consolidated Balance Sheets

    (unaudited – amounts in thousands of U.S. dollars)

     

     

     

    December 31,

    2020

    $

     

    December 31,

    2019

    $

    Assets

     

     

     

     

    Cash, cash equivalents and short term investments

     

    $

    398,329

     

     

    $

    306,019

     

    Accrued interest and other receivables

     

    1,018

     

     

    368

     

    Inventories

     

    13,927

     

     

     

    Prepaid expenses and deposits

     

    6,153

     

     

    8,750

     

    Total current assets

     

    419,427

     

     

    315,137

     

     

     

     

     

     

    Long term investments

     

    24,380

     

     

     

    Other non-current assets

     

    247

     

     

    209

     

    Property and equipment

     

    4,786

     

     

    93

     

    Acquired intellectual property and other intangible assets

     

    9,332

     

     

    8,862

     

    Right of use asset

     

    5,489

     

     

     

    Total assets

     

    $

    463,661

     

     

    $

    324,301

     

     

     

     

     

     

    Liabilities and Shareholders' Equity

     

     

     

     

    Accounts payable and accrued liabilities

     

    24,797

     

     

    11,177

     

    Other current liabilities

     

    7,200

     

     

    118

     

    Total current liabilities

     

    31,997

     

     

    11,295

     

     

     

     

     

     

    Other non-current liabilities

     

    23,914

     

     

    14,406

     

    Total liabilities

     

    55,911

     

     

    25,701

     

     

     

     

     

     

    Shareholders' equity

     

    407,750

     

     

    298,600

     

    Total liabilities and shareholders' equity

     

    $

    463,661

     

     

    $

    324,301

     

     

    Aurinia Pharmaceuticals Inc.

    Consolidated Statements of Operations

    (unaudited – amounts in thousands of U.S. dollars, except per share data)

     

     

     

    Three months ended

     

    Years ended

     

     

    Dec. 31,

    2020

     

    Dec. 31,

    2019

     

    Dec. 31,

    2020

     

    Dec. 31,

    2019

     

     

    $

     

    $

     

    $

     

    $

    Revenue

     

     

     

     

     

     

     

     

    Licensing revenue

     

    $

    50,030

     

     

    $

    29

     

     

    $

    50,118

     

     

    $

    318

     

     

     

     

     

     

     

     

     

     

    Expenses

     

     

     

     

     

     

     

     

    Research and development

     

    13,173

     

     

    13,292

     

     

    50,327

     

     

    52,866

     

    Corporate, administration and business development

     

    38,779

     

     

    7,294

     

     

    95,983

     

     

    22,338

     

    Amortization of intangible assets

     

    387

     

     

    284

     

     

    1,289

     

     

    1,138

     

    Other expenses, net

     

    5,743

     

     

    14,000

     

     

    6,809

     

     

    14,919

     

    Total operating expenses

     

    58,082

     

     

    34,870

     

     

    154,408

     

     

    91,261

     

    Loss from operations

     

    (8,052)

     

     

    (34,841)

     

     

    (104,290)

     

     

    (90,943)

     

    Interest income

     

    135

     

     

    467

     

     

    1,516

     

     

    2,702

     

    Loss before income taxes

     

    (7,917)

     

     

    (34,374)

     

     

    (102,774)

     

     

    (88,241)

     

    Income tax benefit (expense)

     

    (157)

     

     

    (85)

     

     

    94

     

     

    (144)

     

    Net loss and comprehensive loss

     

    (8,074)

     

     

    (34,459)

     

     

    (102,680)

     

     

    (88,385)

     

     

     

     

     

     

     

     

     

     

    Net loss (expressed in $ per share)

     

     

     

     

     

     

     

     

    Basic and diluted loss per Common Share

     

    $

    (0.05)

     

     

    $

    (0.36)

     

     

    $

    (0.87)

     

     

    $

    (0.95)

     

     

     

     

     

     

     

     

     

     

    Weighted average number of Common Shares outstanding

     

    126,618

     

     

    97,936

     

     

    118,473

     

     

    93,024

     

     

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  25. Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) (the "Company") today announced that members of the executive management team will participate in a fireside chat at the (virtual) SVB Leerink 10th Annual Global Healthcare Conference on Thursday, February 25, 2021 at 1:00 p.m. ET.

    In order to participate in the audio webcast, interested parties can access the live webcast under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will be available on Aurinia's website.

    ABOUT AURINIA

    Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations that are impacted by serious diseases with…

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) (the "Company") today announced that members of the executive management team will participate in a fireside chat at the (virtual) SVB Leerink 10th Annual Global Healthcare Conference on Thursday, February 25, 2021 at 1:00 p.m. ET.

    In order to participate in the audio webcast, interested parties can access the live webcast under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will be available on Aurinia's website.

    ABOUT AURINIA

    Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The Company has introduced LUPKYNIS™ (voclosporin), the first FDA-approved oral therapy dedicated for the treatment of adult patients with active lupus nephritis (LN). The Company's head office is in Victoria, British Columbia, its U.S. commercial hub is in Rockville, Maryland, and the Company focuses its development efforts globally.

    View Full Article Hide Full Article
  26. Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) (the "Company") today announced that it will release its fourth quarter and year end 2020 financial results on Wednesday, February 24, 2021, after the markets close. Aurinia's management team will host a conference call to discuss the Company's financial results and to provide a general business update.

    The conference call and webcast is scheduled for February 24, 2021 at 4:30pm ET. In order to participate in the conference call, please dial +1-877-407-9170 (Toll-free U.S. & Canada). An audio webcast can be accessed under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will be available on Aurinia's website…

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) (the "Company") today announced that it will release its fourth quarter and year end 2020 financial results on Wednesday, February 24, 2021, after the markets close. Aurinia's management team will host a conference call to discuss the Company's financial results and to provide a general business update.

    The conference call and webcast is scheduled for February 24, 2021 at 4:30pm ET. In order to participate in the conference call, please dial +1-877-407-9170 (Toll-free U.S. & Canada). An audio webcast can be accessed under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will be available on Aurinia's website.

    ABOUT AURINIA

    Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The Company has introduced LUPKYNIS™ (voclosporin), the first FDA-approved oral therapy dedicated for the treatment of adult patients with active lupus nephritis (LN). The Company's head office is in Victoria, British Columbia, its U.S. commercial hub is in Rockville, Maryland, and the Company focuses its development efforts globally.

    View Full Article Hide Full Article
  27. - LUPKYNIS is the first FDA-approved oral therapy for lupus nephritis (LN), a condition that causes irreversible kidney damage and increases the risk of kidney failure, cardiac events, and death -

    - LUPKYNIS demonstrated significantly improved renal response rates compared to typical standard-of-care (SoC) in clinical trials

    - LUPKYNIS is now commercially available in the U.S. -

    - Multimedia components are available with this press release (link here) -

    - Conference call to be hosted Monday, January 25, 2021, 8:30 a.m. ET -

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) ("Aurinia" or the "Company") today announced that the U.S. Food and Drug Administration (FDA) has approved LUPKYNISTM (voclosporin) in combination with a background…

    - LUPKYNIS is the first FDA-approved oral therapy for lupus nephritis (LN), a condition that causes irreversible kidney damage and increases the risk of kidney failure, cardiac events, and death -

    - LUPKYNIS demonstrated significantly improved renal response rates compared to typical standard-of-care (SoC) in clinical trials

    - LUPKYNIS is now commercially available in the U.S. -

    - Multimedia components are available with this press release (link here) -

    - Conference call to be hosted Monday, January 25, 2021, 8:30 a.m. ET -

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) ("Aurinia" or the "Company") today announced that the U.S. Food and Drug Administration (FDA) has approved LUPKYNISTM (voclosporin) in combination with a background immunosuppressive therapy regimen to treat adult patients with active lupus nephritis (LN). LUPKYNIS is the first FDA-approved oral therapy for LN. LN causes irreversible kidney damage and significantly increases the risk of kidney failure, cardiac events, and death. It is one of the most serious and common complications of the autoimmune disease systemic lupus erythematosus (SLE). LUPKYNIS is now available to patients in the United States (U.S.).

    In pivotal trials, patients treated with LUPKYNIS in combination with standard-of-care (SoC) were more than twice as likely to achieve renal response and experienced a decline in urine protein creatinine ratio (UPCR) twice as fast as patients on typical SoC alone. UPCR is a standard measurement used to monitor protein levels in the kidney. Early intervention and kidney response are linked to better long-term outcomes and prevent irreversible kidney damage. Patients treated with LUPKYNIS showed improved response rates in all parameters across immunologically-active classes of LN studied.

    "The LUPKYNIS approval marks a turning point for the lupus nephritis community – patients, caregivers, families, and healthcare professionals – all of whom we thank for their partnership in the development of this innovative novel treatment. We are thrilled to bring LUPKYNIS to the people impacted by this devastating condition," said Peter Greenleaf, President and Chief Executive Officer of Aurinia Pharmaceuticals. "The approved label supports the efficacy and safety of LUPKYNIS as well as Aurinia's proprietary and patented eGFR pharmacodynamic dosing protocol. We have worked tirelessly to put the correct team and infrastructure in place to ensure we are ready for swift commercial adoption of LUPKYNIS."

    "For years treating patients with lupus nephritis has been challenging. We have had a very limited number of therapeutic options, and these have been only modestly effective but highly toxic," said Brad H. Rovin, M.D., Professor of Medicine and the Director of the Division of Nephrology, Ohio State University Wexler Medical Center, and AURORA clinical trial investigator. "The FDA approval of LUPKYNIS allows us to treat patients safely and more effectively with a rapid acting therapy which requires far less steroids, something our patients will appreciate."

    To assist LUPKYNIS patients and the healthcare provider (HCPs) who prescribe the treatment, Aurinia has developed and launched Aurinia Alliance™, a patient support program featuring dedicated nurse case managers who provide personalized educational resources and assistance in navigating insurance and Aurinia medication costs throughout each patient's LUPKYNIS treatment journey. To learn more about Aurinia Alliance or LUPKYNIS, visit www.LUPKYNIS.com.

    "People with lupus nephritis have desperately needed approved treatments to help them avoid irreversible kidney damage and the eventual need for kidney transplant," said Stevan W. Gibson, President and CEO, Lupus Foundation of America. "The approval of a tailored therapy represents a significant step forward in treating lupus nephritis and is excellent news for the lupus community."

    "Despite strong efforts in research to find solutions for SLE and LN, options to-date have been limited. Once patients progress to LN, they face inevitable life-altering effects," said Kenneth M. Farber, President and CEO, Lupus Research Alliance. "We have long supported Aurinia Pharmaceuticals and are encouraged by the U.S. FDA approval of voclosporin, a much-needed oral treatment option to address the challenges faced by people living with LN."

    "New treatments indicated specifically for lupus nephritis will contribute to our quest for health equity in kidney diseases," commented National Kidney Foundation's Chief Medical Officer Joseph Vassalotti, M.D. "Interventions that are effective to manage and potentially prevent irreversible kidney damage are exciting for people living with lupus nephritis and their clinicians in nephrology and rheumatology."

    "As a patient-led organization who understands all too well the urgent need for more efficacious treatments for people struggling to live with diseases of unmet need like lupus nephritis, we are thrilled with the approval of LUPKYNIS," said Kathleen A. Arntsen President and CEO of Lupus and Allied Diseases Association. "There is now a new treatment for this debilitating and life-diminishing condition that is four times higher for people of African descent and Asians and two times higher for Hispanics/Latinos and Native Americans. At a time when our nation faces extreme challenges such as addressing and overcoming social inequities and health disparities, this is welcome and promising news, especially since both lupus nephritis and COVID-19 disproportionately impact communities of color."

    LUPKYNIS was approved by the FDA under Priority Review and was previously granted Fast Track designation from the Agency in 2016. To learn more visit www.auriniapharma.com.

    Multimedia Components and Conference Call Information

    Multimedia components are available with this press release (link here). Aurinia will host a conference call and webcast to discuss the approval of LUPKYNIS on Monday, January 25, 2021 at 8:30 a.m. ET. The webcast can be accessed on the investor section of the Aurinia website at www.auriniapharma.com. To participate in the teleconference, please dial +1-877-407-9170 (Toll-free U.S. & Canada).

    Clinical Trial Overview of LUPKYNIS (voclosporin)

    The approval of LUPKYNIS is based on data from Aurinia's pioneering late-stage global clinical studies in LN – the pivotal AURORA Phase 3 study and the AURA-LV Phase 2 study. These studies together demonstrated the ability of LUPKYNIS treatment to significantly improve outcomes as reported up to 52 weeks, for patients on several parameters when added to the typical SoC, mycophenolate mofetil (MMF), and low dose steroids.

    In both studies, a total of 533 patients with LN were randomized to receive either LUPKYNIS 23.7 mg or placebo twice daily used with SoC. All patients were dosed with concurrent MMF at a target dose 2 g/day. In both studies, initial treatment with intravenous (IV) methylprednisolone up to a cumulative dose of 1 g was administered on Days 1 and 2, and all patients received a subsequent taper of oral corticosteroids. The starting dose of oral prednisone was 20 mg/day for patients with a body weight of <45 kg and 25 mg/day for patients ≥45 kg. The dose of oral corticosteroid was tapered down to achieve a target dose of 2.5 mg/day by Week 16. The studies enrolled patients with LN of Class III or IV (alone or in combination with Class V) or pure Class V. Enrolled patients were required to have baseline eGFR >45 mL/min/1.73 m2.

    In the Phase 3 study, at one year, LUPKYNIS plus SoC was more than two times as effective at achieving a complete renal response than the SoC alone. Patients in the study taking LUPKYNIS also achieved a 50 percent reduction in UPCR twice as fast as SoC, and a higher portion of LUPKYNIS-treated patients achieved a complete renal response at 24 weeks compared to patients receiving SoC. The study results were achieved using a protocol-defined steroid taper. Patients treated with LUPKYNIS showed improved response rates in all parameters across immunologically-active classes of LN studied.

    The most common adverse reactions (>3%) were glomerular filtration rate decreased, hypertension, diarrhea, headache, anemia, cough, urinary tract infection, abdominal pain upper, dyspepsia, alopecia, renal impairment, abdominal pain, mouth ulceration, fatigue, tremor, acute kidney injury, and decreased appetite.

    About Lupus Nephritis

    Lupus nephritis (LN) is a serious progression of SLE, a chronic, complex and autoimmune disease. About 200,000-300,000 people live with SLE in the U.S. and approximately one out of three of these individuals have already developed LN at the time of SLE diagnosis. If poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney, resulting in kidney failure. Black and Asian individuals with SLE are four times more likely to develop LN and individuals with Hispanic ancestry are approximately twice as likely to develop the disease when compared with Caucasian individuals. Black and Hispanic individuals with SLE also tend to develop LN earlier and have poorer outcomes when compared to Caucasian individuals.

    About Aurinia

    Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The Company has introduced LUPKYNIS (voclosporin), the first FDA-approved oral therapy dedicated for the treatment of adult patients with active lupus nephritis (LN). The Company's head office is in Victoria, British Columbia, its U.S. commercial hub is in Rockville, Maryland, and the Company focuses its development efforts globally.

    INDICATION AND IMPORTANT SAFETY INFORMATION

    INDICATIONS

    LUPKYNIS is indicated in combination with a background immunosuppressive therapy regimen for the treatment of adult patients with active lupus nephritis (LN). Limitations of Use: Safety and efficacy of LUPKYNIS have not been established in combination with cyclophosphamide. Use of LUPKYNIS is not recommended in this situation.

    IMPORTANT SAFETY INFORMATION

    BOXED WARNINGS: MALIGNANCIES AND SERIOUS INFECTIONS

    Increased risk for developing malignancies and serious infections with LUPKYNIS or other immunosuppressants that may lead to hospitalization or death.

    CONTRAINDICATIONS: LUPKYNIS is contraindicated in patients taking strong CYP3A4 inhibitors because of the increased risk of acute and/or chronic nephrotoxicity, and in patients who have had a serious/severe hypersensitivity reaction to LUPKYNIS or its excipients.

    WARNINGS AND PRECAUTIONS

    Lymphoma and Other Malignancies: Immunosuppressants, including LUPKYNIS, increase the risk of developing lymphomas and other malignancies, particularly of the skin. The risk appears to be related to increasing doses and duration of immunosuppression rather than to the use of any specific agent.

    Serious Infections: Immunosuppressants, including LUPKYNIS, increase the risk of developing bacterial, viral, fungal, and protozoal infections (including opportunistic infections), which may lead to serious, including fatal, outcomes.

    Nephrotoxicity: LUPKYNIS, like other calcineurin inhibitors (CNIs), may cause acute and/or chronic nephrotoxicity. The risk is increased when CNIs are concomitantly administered with drugs associated with nephrotoxicity.

    Hypertension: Hypertension is a common adverse reaction of LUPKYNIS therapy and may require antihypertensive therapy.

    Neurotoxicity: LUPKYNIS, like other CNIs, may cause a spectrum of neurotoxicities: severe include posterior reversible encephalopathy syndrome (PRES), delirium, seizure, and coma; others include tremor, paresthesia, headache, and changes in mental status and/or motor and sensory functions.

    Hyperkalemia: Hyperkalemia, which may be serious and require treatment, has been reported with CNIs, including LUPKYNIS. Concomitant use of agents associated with hyperkalemia may increase the risk for hyperkalemia.

    QTc Prolongation: LUPKYNIS prolongs the QTc interval in a dose-dependent manner when dosed higher than the recommended lupus nephritis therapeutic dose. The use of LUPKYNIS in combination with other drugs that are known to prolong QTc may result in clinically significant QT prolongation.

    Immunizations: Avoid the use of live attenuated vaccines during treatment with LUPKYNIS. Inactivated vaccines noted to be safe for administration may not be sufficiently immunogenic during treatment with LUPKYNIS.

    Pure Red Cell Aplasia: Cases of pure red cell aplasia (PRCA) have been reported in patients treated with another CNI immunosuppressant. If PRCA is diagnosed, consider discontinuation of LUPKYNIS.

    Drug-Drug Interactions: Avoid co-administration of LUPKYNIS and strong CYP3A4 inhibitors or with strong or moderate CYP3A4 inducers. Reduce LUPKYNIS dosage when co-administered with moderate CYP3A4 inhibitors. Reduce dosage of certain P-gp substrates with narrow therapeutic windows when co-administered.

    ADVERSE REACTIONS

    The most common adverse reactions (>3%) were glomerular filtration rate decreased, hypertension, diarrhea, headache, anemia, cough, urinary tract infection, abdominal pain upper, dyspepsia, alopecia, renal impairment, abdominal pain, mouth ulceration, fatigue, tremor, acute kidney injury, and decreased appetite.

    SPECIFIC POPULATIONS

    Pregnancy/Lactation: May cause fetal harm. Advise not to breastfeed.

    Renal Impairment: Not recommended in patients with baseline eGFR ≤45 mL/min/1.73 m2 unless benefit exceeds risk. Severe renal impairment: Reduce LUPKYNIS dose.

    Mild and Moderate Hepatic Impairment: Reduce LUPKYNIS dose. Severe hepatic impairment: Avoid LUPKYNIS use.

    Please see Prescribing Information, including Boxed Warning, and Medication Guide for LUPKYNIS.

    Forward-Looking Statements

    Certain statements made in this press release may constitute forward-looking information within the meaning of applicable Canadian securities law and forward-looking statements within the meaning of applicable United States securities law. These forward-looking statements or information include but are not limited to statements or information with respect to: Aurinia's estimates as to the number of patients with SLE in the U.S. and the proportion of those persons who will develop LN; the proportion of Black and Asian individuals, and individuals with Hispanic ancestry, compared to Caucasian individuals, to develop LN; Aurinia enhancing access with a variety of patient services and healthcare engagement initiatives. It is possible that such results or conclusions may change based on further analyses of these data. Words such as "anticipate", "will", "believe", "estimate", "expect", "intend", "target", "plan", "goals", "objectives", "may" and other similar words and expressions, identify forward-looking statements. We have made numerous assumptions about the forward-looking statements and information contained herein, including among other things, assumptions about: the accuracy of the results from our clinical trials; the accuracy of reported data from third party studies and reports; that Aurinia's intellectual property rights are valid and do not infringe the intellectual property rights of third parties. Even though the management of Aurinia believes that the assumptions made, and the expectations represented by such statements or information are reasonable, there can be no assurance that the forward-looking information will prove to be accurate.

    Forward-looking information by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aurinia to be materially different from any future results, performance or achievements expressed or implied by such forward-looking information. Should one or more of these risks and uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in forward-looking statements or information. Such risks, uncertainties and other factors include, among others, the following difficulties we may experience in completing the commercialization of voclosporin; the market for the LN business may not be as estimated; Aurinia may have to pay unanticipated expenses; Aurinia may not be able to obtain sufficient supply to meet commercial demand for voclosporin in a timely fashion; unknown impact and difficulties imposed by the COVID-19 pandemic on our business operations including nonclinical, clinical, regulatory and commercial activities; the results from our clinical studies and from third party studies and reports may not be accurate; and our assets or business activities may be subject to disputes that may result in litigation or other legal claims. Although we have attempted to identify factors that would cause actual actions, events or results to differ materially from those described in forward-looking statements and information, there may be other factors that cause actual results, performances, achievements or events to not be as anticipated, estimated or intended. Also, many of the factors are beyond our control. There can be no assurance that forward-looking statements or information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, you should not place undue reliance on forward-looking statements or information.

    All forward-looking information contained in this presentation is qualified by this cautionary statement. Additional information related to Aurinia, including a detailed list of the risks and uncertainties affecting Aurinia and its business, can be found in Aurinia's most recent Annual Information Form available by accessing the Canadian Securities Administrators' System for Electronic Document Analysis and Retrieval (SEDAR) website at www.sedar.com or the U.S. Securities and Exchange Commission's Electronic Document Gathering and Retrieval System (EDGAR) website at www.sec.gov/edgar

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  28. Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) (the "Company") today announced that members of the management team will participate in two upcoming virtual investor conferences and participate in a panel discussion hosted by Dr. Scott Gottlieb, former FDA Commissioner:

    • H.C. Wainwright Virtual BioConnect 2021 Conference. On-demand fireside chat available beginning Monday, January 11, 2021 at 6:00 a.m. EST;
    • Scott Gottlieb, M.D. Hosts a Panel Discussion on Clinical Trials with Neil Solomons, M.D., Chief Medical Officer of Aurinia, during the H.C. Wainwright BioConnect 2021 Conference on Monday, January 11, 2021 at 12:00 p.m. EST; and
    • J.P Morgan 39th Annual Healthcare Conference. Fireside chat to be hosted on Thursday, January 14, 2021…

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) (the "Company") today announced that members of the management team will participate in two upcoming virtual investor conferences and participate in a panel discussion hosted by Dr. Scott Gottlieb, former FDA Commissioner:

    • H.C. Wainwright Virtual BioConnect 2021 Conference. On-demand fireside chat available beginning Monday, January 11, 2021 at 6:00 a.m. EST;
    • Scott Gottlieb, M.D. Hosts a Panel Discussion on Clinical Trials with Neil Solomons, M.D., Chief Medical Officer of Aurinia, during the H.C. Wainwright BioConnect 2021 Conference on Monday, January 11, 2021 at 12:00 p.m. EST; and
    • J.P Morgan 39th Annual Healthcare Conference. Fireside chat to be hosted on Thursday, January 14, 2021 at 4:30 p.m. EST.

    In order to listen to the audio webcast, interested parties can register and access the live webcast under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will be available for 30 days on Aurinia's website.

    ABOUT AURINIA

    Aurinia Pharmaceuticals is a late-stage clinical biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The Company is currently seeking FDA approval of voclosporin for the potential treatment of lupus nephritis (LN). The Company's head office is in Victoria, British Columbia and its U.S. commercial hub is in Rockville, Maryland. The Company focuses its development efforts globally.

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  29. - Aurinia to receive $50 million U.S. upfront payment in addition to up to $50 million U.S. in regulatory and reimbursement milestone payments -

    - Agreement includes royalties of up to 20 percent on net sales payable to Aurinia -

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) ("Aurinia" or the "Company") today announced it has entered into a collaboration and license agreement with Otsuka Pharmaceutical Co., Ltd. for the development and commercialization of oral voclosporin for the treatment of Lupus Nephritis (LN) in the European Union (EU), Japan, as well as the United Kingdom, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein and Ukraine.

    As part of the agreement, Aurinia will receive an upfront cash payment of $50 million…

    - Aurinia to receive $50 million U.S. upfront payment in addition to up to $50 million U.S. in regulatory and reimbursement milestone payments -

    - Agreement includes royalties of up to 20 percent on net sales payable to Aurinia -

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) ("Aurinia" or the "Company") today announced it has entered into a collaboration and license agreement with Otsuka Pharmaceutical Co., Ltd. for the development and commercialization of oral voclosporin for the treatment of Lupus Nephritis (LN) in the European Union (EU), Japan, as well as the United Kingdom, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein and Ukraine.

    As part of the agreement, Aurinia will receive an upfront cash payment of $50 million U.S. and has the potential to receive up to $50 million U.S. in regulatory and reimbursement milestone payments. Aurinia will receive tiered royalties ranging from 10 to 20 percent (dependent on achievement of sale milestones) on net sales upon commercialization, along with additional milestone payments based on the attainment of certain annual sales by Otsuka.

    Voclosporin is a novel, investigational, orally administered treatment developed to treat patients with LN, a chronic, progressive inflammation of the kidneys that is one of the most serious complications of the autoimmune disease systemic lupus erythematosus (SLE).

    The agreement leverages Otsuka's well-recognized expertise in rare kidney diseases to underscore Aurinia's commitment to expanding global access to voclosporin for the treatment of LN. Otsuka expects to file a marketing authorization application (MAA) with the European Medicines Agency (EMA) in Q2 2021 and will also manage the filing of voclosporin for LN with Pharmaceuticals Medical Devices Agency (PDMA) in Japan at a later date. Voclosporin is currently under review with the U.S. Food and Drug Administration (FDA) with an assigned Prescription Drug User Fee Act (PDUFA) target action date of January 22, 2021.

    "Otsuka, with strong capabilities in nephrology and rare disease, is an ideal strategic partner to introduce voclosporin in Europe and Japan," says Peter Greenleaf, President and Chief Executive Officer, Aurinia Pharmaceuticals. "This collaboration will provide Aurinia with additional non-dilutive funds to focus on the successful U.S. launch of voclosporin and support plans to build our pipeline, while ensuring more lupus nephritis patients around the world can benefit from this potentially life-saving medication."

    Makoto Inoue, President and Representative Director of Otsuka Pharmaceutical Co., Ltd. commented, "Effective treatments for lupus nephritis are currently limited and a new treatment option such as voclosporin would be welcomed. We are pleased to enter the collaboration with Aurinia and look forward to delivering this drug to patients in Japan and Europe."

    About Lupus Nephritis

    LN is an inflammation of the kidney caused by SLE and represents a serious progression of SLE. SLE is a chronic, complex and often disabling disorder. The disease is highly heterogeneous, affecting a wide range of organs and tissue systems. Unlike SLE, LN has straightforward disease outcomes, where an early reduction in proteinuria correlates with positive long-term outcomes. In patients with LN, renal damage results in proteinuria and/or hematuria and a decrease in renal function as evidenced by reduced eGFR, and increased serum creatinine levels. LN is debilitating and costly and if poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney, resulting in end-stage renal disease (ESRD), thus making LN a serious and potentially life-threatening condition.

    About Voclosporin

    Voclosporin is a novel therapy in development for patients with LN, an inflammation of the kidney which is one of the most serious complications of the autoimmune disease SLE. If left untreated, LN can lead to irreversible kidney damage, kidney failure or even death. Through an extensive clinical program, voclosporin has demonstrated superiority to the standard-of-care for LN.

    About Aurinia

    Aurinia Pharmaceuticals is a late-stage clinical biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The Company is currently seeking FDA approval of voclosporin for the potential treatment of LN. The Company's head office is in Victoria, British Columbia and its U.S. commercial hub is in Rockville, Maryland. The Company focuses its development efforts globally.

    About Otsuka

    Otsuka Pharmaceutical is a global healthcare company with the corporate philosophy: "Otsuka-people creating new products for better health worldwide." Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for the maintenance of everyday health.

    In pharmaceuticals, Otsuka is a leader in the challenging area of mental health and has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a "big venture" company at heart, applying a youthful spirit of creativity in everything it does.

    Otsuka Pharmaceutical is a subsidiary of Otsuka Holdings Co., Ltd., based in Japan. The Otsuka group of companies employed 47,000 people worldwide and had consolidated sales of approximately USD 13 billion in 2019.

    All Otsuka stories start by taking the road less travelled. Learn more about Otsuka Pharmaceutical Company on its global website at https://www.otsuka.co.jp/en.

    Forward-Looking Statements

    Certain statements made in this press release may constitute forward-looking information within the meaning of applicable Canadian securities law and forward-looking statements within the meaning of applicable United States securities law. These forward-looking statements or information include but are not limited to statements or information with respect to: the Company receiving up to $50 million U.S. in regulatory and reimbursement milestone payments; the Company receiving tiered royalties ranging from 10 to 20 percent (dependent on achievement of sale milestones) and additional milestone payments based on annual sales by Otsuka; Otsuka filing an MAA with the EMA in Q2 2021; plans to build the Company's pipeline; the agreement with Otsuka ensuring more LN patients around the world benefit from voclosporin; and the Company's anticipated PDUFA date of January 22, 2021. It is possible that such results or conclusions may change based on further analyses of these data. Words such as "anticipate", "will", "believe", "estimate", "expect", "intend", "target", "plan", "goals", "objectives", "may" and other similar words and expressions, identify forward-looking statements. We have made numerous assumptions about the forward-looking statements and information contained herein, including among other things, assumptions about: the regulatory and reimbursement milestones will be achieved and the milestones payments made; and the FDA will not alter the PDUFA date; Aurinia will be able to obtain all necessary regulatory approvals for commercialization of voclosporin for use in LN on terms that are acceptable to it and that are commercially viable including approval of marketing authorization applications and new drug approvals, as well as favourable product labeling; and that Aurinia's intellectual property rights are valid and do not infringe the intellectual property rights of other parties. Even though the management of Aurinia believes that the assumptions made, and the expectations represented by such statements or information are reasonable, there can be no assurance that the forward-looking information will prove to be accurate.

    Forward-looking information by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aurinia to be materially different from any future results, performance or achievements expressed or implied by such forward-looking information. Should one or more of these risks and uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in forward-looking statements or information. Such risks, uncertainties and other factors include, among others, the following: Aurinia may not be able to obtain necessary regulatory approvals for commercialization of voclosporin in a timely fashion, or at all; the regulatory, reimbursement and sales milestones may not be achieved. Although we have attempted to identify factors that would cause actual actions, events or results to differ materially from those described in forward-looking statements and information, there may be other factors that cause actual results, performances, achievements or events to not be as anticipated, estimated or intended. Also, many of the factors are beyond our control. There can be no assurance that forward-looking statements or information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, you should not place undue reliance on forward-looking statements or information.

    Except as required by law, Aurinia will not update forward-looking information. All forward-looking information contained in this press release is qualified by this cautionary statement. Additional information related to Aurinia, including a detailed list of the risks and uncertainties affecting Aurinia and its business can be found in Aurinia's most recent Annual Information Form available by accessing the Canadian Securities Administrators' System for Electronic Document Analysis and Retrieval (SEDAR) website at www.sedar.com or the U.S. Securities and Exchange Commission's Electronic Document Gathering and Retrieval System (EDGAR) website at www.sec.gov/edgar.

    We seek safe harbour.

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  30. - State-of-the-Art Monoplant Will Provide Cost and Production Efficiency and Secure Active Pharmaceutical Ingredient (API) Supply for Future Commercial Demand -

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) ("Aurinia") and Lonza Ltd. (SIX: LONN) ("Lonza") today announced they have expanded their exclusive manufacturing relationship. The parties entered into a collaborative agreement to build a dedicated manufacturing capacity within Lonza's existing small molecule API facility in Visp, Switzerland. The dedicated facility (also referred to as "monoplant") will be equipped with state-of-the-art manufacturing equipment to provide cost and production efficiency for the manufacture of voclosporin, while expanding existing capacity and providing…

    - State-of-the-Art Monoplant Will Provide Cost and Production Efficiency and Secure Active Pharmaceutical Ingredient (API) Supply for Future Commercial Demand -

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) ("Aurinia") and Lonza Ltd. (SIX: LONN) ("Lonza") today announced they have expanded their exclusive manufacturing relationship. The parties entered into a collaborative agreement to build a dedicated manufacturing capacity within Lonza's existing small molecule API facility in Visp, Switzerland. The dedicated facility (also referred to as "monoplant") will be equipped with state-of-the-art manufacturing equipment to provide cost and production efficiency for the manufacture of voclosporin, while expanding existing capacity and providing supply security to meet future commercial demand.

    The new agreement builds on the parties' successful multi-year relationship. The agreement, which is conditional upon U.S. regulatory approval of voclosporin, does not impact the launch supply for voclosporin as this is secured by existing inventory. The monoplant is estimated to be operational in 2023.

    "Lonza's world-class expertise and partnership have helped Aurinia to cost-effectively optimize the unique and complex manufacturing process required for the synthesis of voclosporin," said Peter Greenleaf, President and Chief Executive Officer of Aurinia Pharmaceuticals. "We are currently well-poised and ready with adequate product supply for launch and anticipated market demand. A dedicated production capability will help keep our manufacturing costs down and ensure long-term flexibility to meet future demand for years to come."

    "This collaboration is a great example of how we can support both early and commercial-stage biopharmaceutical companies through innovation in manufacturing technology and flexible business models," said Gordon Bates, President Small Molecules Division, Lonza. "We are looking forward to further developing our relationship with Aurinia into a long and productive collaboration to supply this innovative medicine to patients across the globe."

    Following U.S. regulatory approval of voclosporin, Aurinia will commence several capital expenditure payments. Upon completion of the monoplant, Aurinia will have the right to maintain unobstructed use of the monoplant by paying a quarterly fixed facility fee.

    The U.S. Food and Drug Administration (FDA) accepted the filing of Aurinia's NDA for voclosporin in the treatment of lupus nephritis (LN), granted Priority Review, and assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 22, 2021.

    About Voclosporin

    Voclosporin is a novel therapy in development for patients with LN, an inflammation of the kidney which is one of the most serious complications of the autoimmune disease systemic lupus erythematosus (SLE). If left untreated, LN can lead to irreversible kidney damage, kidney failure or even death. Through an extensive clinical program, voclosporin has demonstrated superiority to the standard-of-care for LN. Voclosporin is now under review by the FDA with Fast Track status and Priority Review as a potential therapy for LN in the United States.

    About Aurinia

    Aurinia Pharmaceuticals is a late-stage clinical biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The Company is currently seeking FDA approval of voclosporin for the potential treatment of LN. The Company's head office is in Victoria, British Columbia and its U.S. commercial hub is in Rockville, Maryland. The Company focuses its development efforts globally.

    About Lonza

    At Lonza, we combine technological innovation with world class manufacturing and process excellence. Together, these enable our customers to deliver their discoveries in the healthcare, preservation, and protection sectors.

    We are a preferred global partner to the pharmaceutical, biotech and specialty ingredients markets. We work to prevent illness and promote a healthier world by enabling our customers to deliver innovative medicines that help treat or even cure a wide range of diseases. We also offer a broad range of microbial control solutions, which help to create and maintain a healthy environment.

    Founded in 1897 in the Swiss Alps, Lonza today operates in 120 sites and offices in more than 35 countries. With approximately 15,500 full-time employees, we are built from high-performing teams and of individual employees who make a meaningful difference to our own business, as well as the communities in which we operate. The company generated sales of CHF 5.9 billion in 2019 with a CORE EBITDA of CHF 1.6 billion. Find out more at www.lonza.com and follow us on Twitter @LonzaGroup or Facebook @LonzaGroupAG.

    Forward-Looking Statements

    Certain statements made in this press release may constitute forward-looking information within the meaning of applicable Canadian securities law and forward-looking statements within the meaning of applicable United States securities law. These forward-looking statements or information include but are not limited to statements or information with respect to: equipment at the monoplant facility being state-of-the-art; Aurinia expecting future commercial demand for voclosporin; the monoplant being operational by 2023; Aurinia being poised for increased adoption of and increased need for voclosporin; the PDUFA target action date of January 22, 2021. It is possible that such results or conclusions may change based on further analyses of these data. Words such as "anticipate", "will", "believe", "estimate", "expect", "intend", "target", "plan", "goals", "objectives", "may" and other similar words and expressions, identify forward-looking statements. We have made numerous assumptions about the forward-looking statements and information contained herein, including among other things, assumptions about: monoplant buildout occurring on anticipated timelines; Aurinia will be able to obtain all necessary regulatory approvals for commercialization of voclosporin for use in LN on terms that are acceptable to it and that are commercially viable; and that Aurinia's intellectual property rights are valid and do not infringe the intellectual property rights of other parties. Even though management of Aurinia believes that the assumptions made, and the expectations represented by such statements or information are reasonable, there can be no assurance that the forward-looking information will prove to be accurate.

    Forward-looking information by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aurinia to be materially different from any future results, performance or achievements expressed or implied by such forward-looking information. Should one or more of these risks and uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in forward-looking statements or information. Such risks, uncertainties and other factors include, among others, the following: difficulties we may experience in completing the development and commercialization of voclosporin; and the monoplant may have operational issues once underway that could result in production being limited or reduced from anticipated capacities; the monoplant could be subject to delays in construction, or construction may not be completed at all; the market for voclosporin for use in LN may not be as anticipated. Although we have attempted to identify factors that would cause actual actions, events or results to differ materially from those described in forward-looking statements and information, there may be other factors that cause actual results, performances, achievements or events to not be as anticipated, estimated or intended.

    Also, many of the factors are beyond our control. There can be no assurance that forward-looking statements or information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, you should not place undue reliance on forward-looking statements or information.

    Except as required by law, Aurinia will not update forward-looking information. All forward-looking information contained in this press release is qualified by this cautionary statement. Additional information related to Aurinia, including a detailed list of the risks and uncertainties affecting Aurinia and its business can be found in Aurinia's most recent Annual Information Form available by accessing the Canadian Securities Administrators' System for Electronic Document Analysis and Retrieval (SEDAR) website at www.sedar.com or the U.S. Securities and Exchange Commission's Electronic Document Gathering and Retrieval System (EDGAR) website at www.sec.gov/edgar.

    Additional Information and Disclaimer (Lonza)

    Lonza Group Ltd has its headquarters in Basel, Switzerland, and is listed on the SIX Swiss Exchange. It has a secondary listing on the Singapore Exchange Securities Trading Limited ("SGX-ST"). Lonza Group Ltd is not subject to the SGX-ST's continuing listing requirements but remains subject to Rules 217 and 751 of the SGX-ST Listing Manual.

    Certain matters discussed in this news release may constitute forward-looking statements. These statements are based on current expectations and estimates of Lonza Group Ltd, although Lonza Group Ltd can give no assurance that these expectations and estimates will be achieved. Investors are cautioned that all forward-looking statements involve risks and uncertainty and are qualified in their entirety. The actual results may differ materially in the future from the forward-looking statements included in this news release due to various factors. Furthermore, except as otherwise required by law, Lonza Group Ltd disclaims any intention or obligation to update the statements contained in this news release.

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  31. Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) (the "Company") today announced its participation in the Piper Sandler 32nd Annual Virtual Healthcare Conference. Presentations will be available for registered attendees via the Piper Sandler conference site through December 3.

    In order to listen to the audio webcast, interested parties can register and access the live webcast under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will be available for 30 days on Aurinia's website.

    ABOUT AURINIA

    Aurinia Pharmaceuticals is a late-stage clinical biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations…

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) (the "Company") today announced its participation in the Piper Sandler 32nd Annual Virtual Healthcare Conference. Presentations will be available for registered attendees via the Piper Sandler conference site through December 3.

    In order to listen to the audio webcast, interested parties can register and access the live webcast under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will be available for 30 days on Aurinia's website.

    ABOUT AURINIA

    Aurinia Pharmaceuticals is a late-stage clinical biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The Company is currently seeking FDA approval of voclosporin for the potential treatment of LN. The Company's head office is in Victoria, British Columbia and its U.S. commercial hub is in Rockville, Maryland. The Company focuses its development efforts globally.

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  32. Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (TSX:AUP) ("Aurinia" or the "Company"), a late-stage clinical biopharmaceutical company, today announced that the Company's Compensation Committee granted the newly appointed Executive Vice President, General Counsel, Corporate Secretary & Chief Compliance Officer, Stephen Robertson, a non-qualified stock option to purchase an aggregate of 298,924 common shares on November 16, 2020. The option has a per share exercise price of $13.40 USD, the closing trading price on November 13, 2020. One-third of the shares underlying the option vest in November 2021, and the balance of the shares vest in a series of 24 equal monthly installments thereafter. The inducement option was granted as an inducement material…

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (TSX:AUP) ("Aurinia" or the "Company"), a late-stage clinical biopharmaceutical company, today announced that the Company's Compensation Committee granted the newly appointed Executive Vice President, General Counsel, Corporate Secretary & Chief Compliance Officer, Stephen Robertson, a non-qualified stock option to purchase an aggregate of 298,924 common shares on November 16, 2020. The option has a per share exercise price of $13.40 USD, the closing trading price on November 13, 2020. One-third of the shares underlying the option vest in November 2021, and the balance of the shares vest in a series of 24 equal monthly installments thereafter. The inducement option was granted as an inducement material to the new employee entering into employment with Aurinia in accordance with Nasdaq Listing Rule 5635(c)(4). For the purposes of TSX approval, the Company relied on the exemption set forth in Section 602.1 of the TSX Company Manual, which provides that the TSX will not apply its standards to certain transactions involving eligible inter-listed issuers on a recognized exchange, such as Nasdaq.

    The inducement stock option also has a ten-year term and is subject to the terms and conditions of the stock option agreement pursuant to which the option was granted.

    About Aurinia

    Aurinia Pharmaceuticals is a late clinical-stage biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The Company is currently developing the investigational drug, voclosporin, for the treatment of lupus nephritis. The Company's head office is in Victoria, British Columbia and focuses its development efforts globally. For further information, see our website at www.auriniapharma.com.

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  33. Veteran Pharmaceutical Industry Executives Will Advise Portfolio Companies and Investment Team

    TORONTO, ON / ACCESSWIRE / November 18, 2020 / Lumira Ventures, a leading North American healthcare venture capital firm, today announced the appointment of Theodore Witek, Jr., DrPH, MBA and Daniel Billen, PhD to the role of Special Advisor, and Sena Biswas, PhD, MBA as Venture Partner.

    "We are excited to welcome Ted, Daniel and Sena to the Lumira Ventures team," commented Peter van der Velden, Managing General Partner of Lumira Ventures. "With over 100 years of combined experience in the pharmaceutical and biotechnology industries, they will bring invaluable strategic and operational input to our portfolio companies and assist our investment team in…

    Veteran Pharmaceutical Industry Executives Will Advise Portfolio Companies and Investment Team

    TORONTO, ON / ACCESSWIRE / November 18, 2020 / Lumira Ventures, a leading North American healthcare venture capital firm, today announced the appointment of Theodore Witek, Jr., DrPH, MBA and Daniel Billen, PhD to the role of Special Advisor, and Sena Biswas, PhD, MBA as Venture Partner.

    "We are excited to welcome Ted, Daniel and Sena to the Lumira Ventures team," commented Peter van der Velden, Managing General Partner of Lumira Ventures. "With over 100 years of combined experience in the pharmaceutical and biotechnology industries, they will bring invaluable strategic and operational input to our portfolio companies and assist our investment team in the identification, evaluation and building of new companies developing transformative biomedical innovations."

    Dr. Witek has over three decades of clinical development and executive leadership experience. After joining Boehringer Ingelheim in 1992, as leader of the Respiratory and Immunology clinical research groups he led the global clinical development and launch of several respiratory products, most notably Spiriva®, and eventually served as President and CEO of Boehringer Ingelheim's Canadian and Portuguese operations. He served on the Board of Directors of Canada's Research-Based Pharmaceutical Companies (Rx&D) and was the Chair of the Health Technology Assessment Committee. He also served over ten years on the Drug/Device Discovery and Development Committee of the American Thoracic Society, serving as Chairman from 2010 to 2012. Dr. Witek was appointed to the Ontario Health Innovation Council and is currently Adjunct Professor and Senior Fellow at the Institute of Health Policy Management & Evaluation at University of Toronto. He holds a Doctor of Public Health degree from Columbia University, a Master of Public Health from Yale University, and a Master of Business Administration from Henley Management College.

    Dr. Billen brings over 40 years of experience in the commercialization of pharmaceutical and biotechnology products in North America and Europe. He started with Janssen in their Belgian headquarters in cardiovascular global marketing, later becoming head of marketing and sales for Janssen's newly formed affiliate in Canada where he launched multiple products into the Canadian market. Dr. Billen joined Amgen in 1991 to lead its Canadian operations as the company's first General Manager. He later moved to Amgen's headquarters in California where he led the U.S. commercial operations business unit and later the combined nephrology and inflammation business unit as Vice President and General Manager. He later served as Amgen's Vice President of Global Commercial Initiatives with a focus on the evolving U.S. payer landscape. Since April 2019, Dr. Billen has been a director of Lumira portfolio company Aurinia Pharmaceuticals (NASDAQ:AUPH). Dr. Billen received his PhD in chemistry from the University of Louvain in Belgium.

    Dr. Biswas has over three decades of experience as a biotechnology CEO, researcher, business development executive and venture capital investor. He has recently served as interim CEO at Mimetogen Pharmaceuticals and at Lumira portfolio companies KalGene Pharmaceuticals and OsteoQC. For over thirteen years he was a Managing Director at VIMAC Ventures, an early-stage life sciences venture capital firm in Boston. He was the first employee and President of Merrimack Pharmaceuticals which subsequently grew to a peak market capitalization of over $1.5 billion and successfully launched a cancer drug. Earlier in his career, Dr. Biswas was Director of Business Development at Rhone-Poulenc Rorer executing over 100 licensing and M&A transactions; Principal at TL Ventures, a $1.4 billion venture capital firm where he invested in the Series A rounds of Esperion, Adolor, ViroPharma, all of which became NASDAQ listed companies; and member of the Healthcare Investment Banking team at Bear, Stearns & Co. He holds a BA in Biology from Brandeis University, a PhD in Molecular and Cellular Biology from the University of Pennsylvania, an MBA from the Wharton School, and completed a postdoctoral fellowship in molecular immunology at Harvard Medical School.

    About Lumira Ventures
    Since our founding in 2007, Lumira Ventures has a built a track record as a leading North American healthcare venture capital firm, investing in innovative companies in the biotechnology, medical device, digital health and consumer health sectors. Our goal is to partner with entrepreneurs in Canada and the U.S. to build companies from the seed through growth stages whose products deliver transformative improvements in the lives of patients worldwide. Our companies have brought dozens of biomedical innovations to the market impacting the lives of over 1 billion patients and generating over $70 billion of cumulative revenue. Lumira Ventures has offices in Toronto, Montréal, Vancouver and Boston. For more information, please visit www.lumiraventures.com.

    Contact Information
    Peter van der Velden
    Managing General Partner
    plv@lumira.vc

    SOURCE: Lumira Ventures



    View source version on accesswire.com:
    https://www.accesswire.com/617220/Lumira-Ventures-Appoints-Special-Advisors-and-Venture-Partner

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  34. Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) (the "Company") today announced that members of the senior management team will participate in a fireside chat during the 2020 Jefferies Virtual London Healthcare Conference on November 19, 2020 at 11:25 a.m. ET.

    In order to participate in the audio webcast, interested parties can register and access the live webcast under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will be available on Aurinia's website.

    ABOUT AURINIA

    Aurinia Pharmaceuticals is a late-stage clinical biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are impacted by serious…

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) (the "Company") today announced that members of the senior management team will participate in a fireside chat during the 2020 Jefferies Virtual London Healthcare Conference on November 19, 2020 at 11:25 a.m. ET.

    In order to participate in the audio webcast, interested parties can register and access the live webcast under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will be available on Aurinia's website.

    ABOUT AURINIA

    Aurinia Pharmaceuticals is a late-stage clinical biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The Company is currently seeking FDA approval of voclosporin for the potential treatment of LN. The Company's head office is in Victoria, British Columbia and its U.S. commercial hub is in Rockville, Maryland. The Company focuses its development efforts globally.

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  35. - U.S. Food & Drug Administration grants Priority Review for voclosporin and sets PDUFA date of January 22, 2021 -

    - Cash, cash equivalents and investments totaled approximately $421 million at September 30, 2020 -

    - Conference call and webcast to be hosted today at 4:30pm EDT -

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) ("Aurinia" or the "Company") today reported financial results for the third quarter ended September 30, 2020 and provided an update on recent operational highlights. Amounts, unless specified otherwise, are expressed in U.S. dollars.

    "Throughout the course of 2020, Aurinia has evolved significantly as an organization as we ready the organization for our next potential phase of growth. With the voclosporin NDA undergoing…

    - U.S. Food & Drug Administration grants Priority Review for voclosporin and sets PDUFA date of January 22, 2021 -

    - Cash, cash equivalents and investments totaled approximately $421 million at September 30, 2020 -

    - Conference call and webcast to be hosted today at 4:30pm EDT -

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) ("Aurinia" or the "Company") today reported financial results for the third quarter ended September 30, 2020 and provided an update on recent operational highlights. Amounts, unless specified otherwise, are expressed in U.S. dollars.

    "Throughout the course of 2020, Aurinia has evolved significantly as an organization as we ready the organization for our next potential phase of growth. With the voclosporin NDA undergoing Priority Review for LN, we are focused as an organization to being fully prepared for a potential launch by year-end as the January 22, 2021 PDUFA date approaches," commented Peter Greenleaf, President and Chief Executive Officer of Aurinia. "In addition to preparing for commercialization, we continue to evaluate opportunities to strengthen the development pipeline and look forward to providing updates on our efforts in the coming months."

    Max Colao, Chief Commercial Officer of Aurinia commented, "Over the past few months, we have onboarded and deployed an amazingly talented commercial team that shares our passion for making a difference for patients. As our potential PDUFA date approaches, the team is focused on launch readiness by year-end in order to maximize the potential launch of voclosporin."

    Recent Highlights

    New Drug Application (NDA) for voclosporin granted Priority Review and January 22, 2021 PDUFA date

    In July 2020, the Company announced that the U.S. Food and Drug Administration (FDA) has accepted the NDA filing for voclosporin, as a potential treatment for lupus nephritis (LN). The FDA has granted Priority Review for the NDA, which provides an expedited six-month review, and has assigned a PDUFA target action date of January 22, 2021. The FDA has also informed the Company that they are not currently planning to hold an advisory committee meeting to discuss the application. The FDA has the option to change this decision based on review of the pending NDA. There are currently no FDA-approved treatments for LN.

    Appointment of Stephen Robertson as Executive Vice President, General Counsel, Corporate Secretary & Chief Compliance Officer

    On November 2, Aurinia appointed Mr. Robertson as Executive Vice President, General Counsel, Corporate Secretary & Chief Compliance Officer, following the departure of Dr. Erik Eglite, who served as General Counsel since 2017. Mr. Robertson brings more than 13 years of corporate law experience across various roles with the law firm Borden Ladner Gervais LLP, where he has been a Partner since 2014. He has focused on advising clients on securities, corporate and commercial legal matters, including extensive experience with mergers and acquisitions and commercial agreements. Mr. Robertson has served as Corporate Secretary for Aurinia since 2014.

    July 27, 2020 Public Offering

    On July 27, 2020 the Company completed an underwritten public offering of 13.33 million Common Shares (the "July 2020 Offering").

    The Common Shares were sold at a public offering price of $15.00 per share. The gross proceeds from the July 2020 Offering were $200 million before deducting the 6% underwriting commission and other offering expenses which totaled an estimated aggregate $12.3 million. Jefferies and SVB Leerink acted as joint book-running managers for the July 2020 Offering. Cantor acted as lead manager and Oppenheimer & Co and H.C. Wainwright & Co. acted as co-managers for the July 2020 Offering. We intend to use the net proceeds of the July 2020 Offering for pre-commercialization and launch activities, research and development (R&D), as well as working capital and general corporate purposes.

    Financial Liquidity at September 30, 2020

    As of September 30, 2020, Aurinia had cash, cash equivalents and investments of $421 million compared to $306 million at December 31, 2019. Net cash used in operating activities was $30.3 million for the third quarter ended September 30, 2020 compared to $11.8 million for the third quarter ended September 30, 2019.

    The Company believes that it has sufficient financial resources to fund its current plans, which include conducting its ongoing R&D programs, obtaining approval of voclosporin for the potential treatment of LN, conducting pre-commercial and launch activities, manufacturing and packaging commercial drug supply required for launch, and fund its supporting corporate and working capital needs through the end of 2022.

    Financial Results for Three Months Ended September 30, 2020

    The Company reported a consolidated net loss of $34.1 million or $0.28 per Common Share for the third quarter ended September 30, 2020, as compared to a consolidated net loss of $19.0 million or $0.21 per Common Share for the third quarter ended September 30, 2019.

    The net loss for the third quarter ended September 30, 2020 reflected a non-cash decrease of $2.6 million in the estimated fair value of derivative warrant liabilities compared to a non-cash decrease of $4.5 million in the estimated fair value of derivative warrant liabilities for the same period in 2019. The derivative warrant liabilities will ultimately be eliminated on the exercise or forfeiture of the warrants and will not result in any cash outlay by the Company. The outstanding warrants expire on December 28, 2021.

    The loss before the change in estimated fair value of derivative warrant liabilities and income taxes was $36.7 million for the third quarter ended September 30, 2020 compared to $23.5 million for the same period in 2019.

    R&D expenses decreased to $4.8 million for the third quarter ended September 30, 2020 compared to $17.8 million for the same period in 2019. The decrease is due to a decrease in activities related to clinical trials and exploratory development work and the capitalization of inventory and internal development costs as management believes that approval by the FDA of voclosporin as a treatment for LN was reasonably assured.

    Non-cash stock compensation expense charged to R&D increased to $814,000 for the third quarter ended September 30, 2020 compared to $596,000 for the same period in 2019. The increase in stock option compensation expense for the three months ended September 30, 2020 reflected higher stock option grants resulting from the hiring of new employees and an increase in the fair value of the stock options granted due to the significant increase in our share price.

    Corporate, administration and business development expenses increased to $31.1 million for the third quarter of 2020 compared to $6.1 million for the same period in 2019. The increase reflects the investment incurred to build out our organization to support the launch of voclosporin as a treatment for LN which is planned for early 2021, subject to FDA regulatory approval being granted. Since the release of the positive results of our AURORA trial in December of 2019 we have moved quickly to develop our commercial capabilities across the organization including the expansion of the commercial team headed by our new Chief Commercial Officer.

    Non-cash stock compensation expense charged to corporate, administration and business development increased to $3.8 million for the third quarter ended September 30, 2020 compared to $1.4 million for the same period in 2019. The increase in stock option compensation expense for the three months ended September 30, 2020 reflected higher stock option grants resulting from the hiring of new employees and an increase in the fair value of the stock options granted due to the significant increase in our share price.

    Financial Results for Nine Months Ended September 30, 2020

    For the nine months ended September 30, 2020, Aurinia reported a consolidated net loss of $80.1 million or $0.69 per Common Share compared to a consolidated net loss of $47.4 million or $0.52 per common share for the same period in 2019.

    R&D expenses were $29.7 million for the nine months ended September 30, 2020 compared to $39.6 million for the same period in 2019. The decrease in these expenses is due to a decrease in activities related to clinical trials and exploratory development work and the capitalization of inventory and internal development costs as management believes that approval by the FDA of voclosporin as a treatment for LN was reasonably assured.

    Corporate, administration and business development expenses were $57.7 million for the nine months ended September 30, 2020 compared to $14.9 million for the same period in 2019. The increase reflects the investment incurred to build out our organization to support the launch of voclosporin as a treatment for LN which is planned for early 2021, subject to FDA regulatory approval being granted. Since the release of the positive results of our AURORA trial in December of 2019 we have moved quickly to develop our commercial capabilities across the organization including the expansion of the commercial team headed by our new Chief Commercial Officer.

    Non-cash stock compensation expense totaled $12.3 million for the nine months ended September 30, 2020 compared with $5.6 million for the same period in 2019 and is included in both R&D and corporate, general and business development expenses.

    For the nine months ended September 30, 2020 Aurinia recorded a non-cash decrease of $9.5 million in the estimated fair value of derivative warrant liabilities compared to a non-cash decrease of $6.9 million for the comparable period in 2019.

    This press release should be read in conjunction with our unaudited interim condensed consolidated financial statements and the Management's Discussion and Analysis for the third quarter ended September 30, 2020 which are accessible on Aurinia's website at www.auriniapharma.com, on SEDAR at www.sedar.com or on EDGAR at www.sec.gov/edgar.

    Aurinia will host a conference call and webcast to discuss the third quarter ended September 30, 2020 financial results today, Tuesday, November 10, 2020 at 4:30 p.m. ET. The webcast can be accessed on the investor section of the Aurinia website at www.auriniapharma.com. To participate in the teleconference please dial +1-877-407-9170 (Toll-free U.S. & Canada).

    About Voclosporin

    Voclosporin, an investigational drug, is a novel and potentially best-in-class calcineurin inhibitor ("CNI") with clinical data in over 2,600 patients across indications. Voclosporin is an immunosuppressant, with a synergistic and dual mechanism of action. By inhibiting calcineurin, voclosporin blocks IL-2 expression and T-cell mediated immune responses and stabilizes the podocyte in the kidney. Voclosporin may result in a more predictable pharmacokinetic and pharmacodynamic relationship (potentially requires no therapeutic drug monitoring), an increase in potency (versus cyclosporine A), and an improved metabolic profile compared to legacy CNIs. Aurinia anticipates that upon regulatory approval, patent protection for voclosporin will be extended in the United States and certain other major markets, including Europe and Japan, until at least October 2027 under the Hatch-Waxman Act and comparable patent extension laws in other countries with anticipated pediatric extension. Further, a U.S. patent has also been issued covering the voclosporin dosing protocol with a term extending to December 2037, if the FDA incorporates the dosing protocol used in both the AURA and AURORA trials into the product label.

    ABOUT AURINIA

    Aurinia Pharmaceuticals is a late-stage clinical biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The Company is currently developing the investigational drug voclosporin for the treatment of lupus nephritis ("LN"). The Company's head office is in Victoria, British Columbia and focuses its development efforts globally. The Company's US commercial office is located in Rockville, Maryland.

    Forward-Looking Statements

    Certain statements made in this press release may constitute forward-looking information within the meaning of applicable Canadian securities law and forward-looking statements within the meaning of applicable United States securities law. These forward-looking statements or information include but are not limited to statements or information with respect to: the anticipated NDA filing by the end of the third quarter of 2020 and potential approval in early 2021; the Company's continued evolution into a commercial-stage organization; the anticipated U.S. launch of Voclosporin as the first FDA-approved treatment for LN; the Company's belief that it has sufficient cash resources to adequately fund its plans which include conducting its ongoing R&D programs, completing the NDA submission to the FDA, conducting pre-commercial and launch activities, manufacturing and packaging commercial drug supply required for launch, and fund its supporting corporate and working capital needs through the end of 2022; voclosporin being potentially a best-in-class CNI with robust intellectual property exclusivity; Aurinia's anticipation that upon regulatory approval, patent protection for voclosporin composition of matter will be extended in the United States and certain other major markets, including Europe and Japan, until at least October 2027 under the Hatch-Waxman Act and comparable laws in other countries with anticipated pediatric extension; and a US patent has also been issued covering the voclosporin dosing protocol with a term extending to December 2037, if the FDA incorporates the dosing protocol used in both the AURA and the AURORA studies into the product label. It is possible that such results or conclusions may change based on further analyses of these data. Words such as "anticipate", "will", "believe", "estimate", "expect", "intend", "target", "plan", "goals", "objectives", "may" and other similar words and expressions, identify forward-looking statements. We have made numerous assumptions about the forward-looking statements and information contained herein, including among other things, assumptions about: the market value for the LN programs; that another company will not create a substantial competitive product for Aurinia's LN business without violating Aurinia's intellectual property rights; the burn rate of Aurinia's cash for operations; the costs and expenses associated with Aurinia's clinical trials; that Aurinia will successfully complete its clinical programs on a timely basis; the planned studies achieving positive results; Aurinia being able to extend and protect its patents on terms acceptable to Aurinia; the size of the LN market; Aurinia will be able to obtain all necessary regulatory approvals for commercialization of voclosporin for use in LN on terms that are acceptable to it and that are commercially viable including approval of marketing authorization applications and new drug approvals, as well as favourable product labeling; and that Aurinia's intellectual property rights are valid and do not infringe the intellectual property rights of other parties. Even though the management of Aurinia believes that the assumptions made, and the expectations represented by such statements or information are reasonable, there can be no assurance that the forward-looking information will prove to be accurate.

    Forward-looking information by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aurinia to be materially different from any future results, performance or achievements expressed or implied by such forward-looking information. Should one or more of these risks and uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in forward-looking statements or information. Such risks, uncertainties and other factors include, among others, the following: difficulties, delays, or failures we may experience in the conduct of our clinical trial; difficulties we may experience in completing the development and commercialization of voclosporin; the market for the LN business may not be as estimated; Aurinia may have to pay unanticipated expenses; estimated costs for clinical trials may be underestimated, resulting in Aurinia having to make additional expenditures to achieve its current goals; Aurinia not being able to extend or fully protect its patent portfolio for voclosporin; competitors may arise with similar products; Aurinia may not be able to obtain necessary regulatory approvals for commercialization of voclosporin in a timely fashion, or at all; and Aurinia may not be able to obtain sufficient supply to meet commercial demand for voclosporin in a timely fashion; unknown impact and difficulties imposed by the COVID-19 pandemic on our business operations including nonclinical, clinical, regulatory and commercial activities; and our assets or business activities may be subject to disputes that may result in litigation or other legal claims. Although we have attempted to identify factors that would cause actual actions, events or results to differ materially from those described in forward-looking statements and information, there may be other factors that cause actual results, performances, achievements or events to not be as anticipated, estimated or intended. Also, many of the factors are beyond our control. There can be no assurance that forward-looking statements or information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, you should not place undue reliance on forward-looking statements or information.

    Except as required by law, Aurinia will not update forward-looking information. All forward-looking information contained in this press release is qualified by this cautionary statement. Additional information related to Aurinia, including a detailed list of the risks and uncertainties affecting Aurinia and its business can be found in Aurinia's most recent Annual Information Form available by accessing the Canadian Securities Administrators' System for Electronic Document Analysis and Retrieval (SEDAR) website at www.sedar.com or the U.S. Securities and Exchange Commission's Electronic Document Gathering and Retrieval System (EDGAR) website at www.sec.gov/edgar.

    We seek safe harbour.

    Aurinia Pharmaceuticals Inc.

    Interim Condensed Consolidated Statements of Financial Position

    (unaudited – amounts in thousands of U.S. dollars)

     

    September 30,

    2020

    $

     

    December 31,

    2019

    $

    Assets

     

     

     

    Cash, cash equivalents and short term investments

    392,042

     

    306,019

    Accrued interest and other receivables

    1,127

     

    368

    Inventories

    6,757

     

    -

    Prepaid expenses and deposits

    11,714

     

    8,750

     

    411,640

     

    315,137

     

     

     

     

    Long term investments

    28,797

     

    -

    Clinical trial contract deposits

    209

     

    209

    Property and equipment

    9,663

     

    93

    Acquired intellectual property and other intangible assets

    11,441

     

    11,244

     

    461,750

     

    326,683

     

     

     

     

    Liabilities and Shareholders' Equity

     

     

     

    Accounts payable and accrued liabilities

    20,189

     

    11,177

    Other current liabilities

    3,700

     

    118

     

    23,889

     

    11,295

     

     

     

     

    Derivative warrant liabilities

    19,852

     

    29,353

    Other non-current liabilities

    19,166

     

    12,519

     

    62,907

     

    53,167

     

     

     

     

    Shareholders' equity

    398,843

     

    273,516

    Total liabilities and shareholders' equity

    461,750

     

    326,683 

    Aurinia Pharmaceuticals Inc.

    Interim Condensed Consolidated Statements of Operations

    (unaudited – amounts in thousands of U.S. dollars, except per share data)

    Three months ended

    Nine months ended

    Sept. 30,

    2020

    Sept. 30,

    2019

    Sept. 30,

    2020

    Sept. 30,

    2019

    $

    $

    $

    $

    Revenue

    Licensing revenue

    29

    230

    88

    289

     

     

     

     

    Expenses

    Research and development

    4,800

    17,791

    29,711

    39,574

    Corporate, administration and business development

    31,068

     

    6,061

    57,670

    14,908

    Amortization of acquired intellectual property and other intangible assets

    348

    348

    1,044

    1,041

    Amortization of property and equipment

    154

    41

    354

    116

    Other expenses

    426

    140

    2,351

    1,028

    36,796

    24,381

    91,130

    56,667

    Loss before interest income, finance costs, change in estimated fair value of derivative warrant liabilities and income taxes

    (36,767)

     

    (24,151)

    (91,042)

    (56,378)

    Interest income

    170

    636

     

    1,381

    2,234

    Finance costs

    (101)

     

    (9)

    (204)

     

    (30)

    Loss before change in estimated fair value of derivative warrant liabilities and income taxes

    (36,698)

    (23,524)

    (89,865)

     

    (54,174)

    Change in estimated fair value of derivative warrant liabilities

    2,599

    4,512

    9,492

    6,862

     

     

     

     

    Loss before income taxes

    (34,099)

    (19,012)

    (80,373)

     

    (47,312)

    Income tax (recovery) expense

    (35)

    25

    (249)

    54

    Net loss and comprehensive loss for the period

    (34,064)

    (19,037)

    (80,124)

    (47,366)

     

    Net loss per Common Share (expressed in $ per share)

    Basic and diluted loss per Common Share

    (0.28)

    (0.21)

    (0.69)

    (0.52)

     

     

     

     

    Weighted average number of Common Shares outstanding

    122,357

    92,169

    115,738

    91,368

     

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  36. - Integrated analysis confirms addition of voclosporin to standard-of-care resulted in faster Renal Response compared to standard-of-care alone in lupus nephritis -

    - DDI study demonstrates no clinically meaningful interaction between voclosporin and MMF, supporting differentiation as a potential best-in-class CNI -

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) (Aurinia or the Company), a late-stage clinical biopharmaceutical company, today announced data from an integrated analysis of the AURA-LV and AURORA pivotal trials that further supports voclosporin as a potential treatment for lupus nephritis (LN) in a presentation at the American College of Rheumatology (ACR) Convergence 2020. The Company also shared data from a clinical drug-drug…

    - Integrated analysis confirms addition of voclosporin to standard-of-care resulted in faster Renal Response compared to standard-of-care alone in lupus nephritis -

    - DDI study demonstrates no clinically meaningful interaction between voclosporin and MMF, supporting differentiation as a potential best-in-class CNI -

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) (Aurinia or the Company), a late-stage clinical biopharmaceutical company, today announced data from an integrated analysis of the AURA-LV and AURORA pivotal trials that further supports voclosporin as a potential treatment for lupus nephritis (LN) in a presentation at the American College of Rheumatology (ACR) Convergence 2020. The Company also shared data from a clinical drug-drug interaction (DDI) study in patients with systemic lupus erythematosus (SLE), showing that voclosporin does not have a meaningful drug-drug interaction when administered with mycophenolate mofetil (MMF). The topline results from this DDI study were previously announced in late 2019.

    The data at ACR were presented by Ellen Ginzler, M.D., MPH, Distinguished Teaching Professor of Medicine and Chief of Rheumatology at the SUNY Downstate Health Sciences University and Teun van Gelder, M.D., Ph.D., Professor in Clinical Pharmacology for the Department of Clinical Pharmacy and Toxicology at the Leiden University Medical Center.

    "We are delighted to share more encouraging data on the use of voclosporin for lupus nephritis to this influential group of rheumatology experts at ACR," said Neil Solomons, M.D., Chief Medical Officer of Aurinia. "With few effective options, rheumatologists have struggled to find effective therapies for patients with lupus nephritis. These two studies, along with the growing body of data supporting the use of voclosporin, clearly demonstrate the benefits of this therapy to provide effective and safe treatment."

    The integrated data presented by Dr. Ginzler demonstrated that patients with LN treated with voclosporin in combination with MMF and low-dose steroids achieved statistically superior and faster Renal Response (RR) rates compared to patients treated with MMF and steroids alone. Treatment with voclosporin (VCS) resulted in clinically meaningful and a statistically significant higher RR rate of 43.7% compared to 23.3% in the control arm at one year (OR 2.76, 95% CI: 1.88, 4.05; p < 0.0001) and at six months (VCS 31.7%; placebo 20.3%), [OR: 2.01; 95% CI: 1.34, 3.01; p=0.0008]. Furthermore, a 50% reduction in urine protein/creatine ratio (UPCR) from baseline at any time was achieved by 93.7% of patients treated with voclosporin compared with 75.2% of patients receiving placebo, with a median time to 50% reduction in UPCR of 29 days versus 58 days, respectively. The time taken to reach a 50% reduction in UPCR was significantly shorter for the voclosporin group than the placebo group (HR 1.96; 95% CI: 1.61, 2.38; p<0.0001). At one year, 160 (75.8%) patients in the voclosporin arm and 150 (73.9%) patients in the placebo arm were on oral prednisone ≤ 2.5 mg /d.

    The AURA-LV and AURORA studies were of similar design and conducted in comparable patient populations. The data from both studies for patients treated with the recommended voclosporin dose of 23.7 mg BID (AURORA; n=179, AURA; n=89) or with matching placebo (AURORA; n= 179, AURA-LV; n=89) were therefore pooled for an integrated analysis of efficacy.

    Dr. Van Gelder presented data from a clinical DDI study in patients with SLE that investigated the potential effect of voclosporin on blood levels of mycophenolate acid (MPA), the active moiety MMF. MMF, also known as CellCept®, is considered by treating physicians to be part of the current standard of care for LN in the United States. The study demonstrated for the first time that voclosporin does not have a meaningful drug-drug interaction when administered with MMF. In contrast to cyclosporine A, voclosporin does not have clinically significant impacts on MPA blood concentrations, which indicates that voclosporin and MMF can be administered concomitantly without the need to adjust the dose of MMF.

    These data presented at ACR Convergence 2020 were submitted as part of voclosporin's new drug application (NDA) to the United States Food and Drug Administration (FDA). The FDA accepted the NDA and has assigned a Prescription Drug User Fee Act (PDUFA) target action data of January 22, 2021.

    About Aurinia

    Aurinia Pharmaceuticals is a late-stage clinical biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The Company is currently seeking FDA approval of voclosporin for the potential treatment of LN. The Company's head office is in Victoria, British Columbia and its U.S. commercial hub is in Rockville, Maryland. The Company focuses its development efforts globally.

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  37. - The trial did not achieve statistical significance on the primary endpoint of ≥ 10mm improvement in Schirmer Tear Test (STT) at 4 weeks –
    - Company to suspend development program for voclosporin ophthalmic solution (VOS) -
    - Aurinia to host conference call today at 4:30 p.m. EST -

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) ("Aurinia" or the "Company"), a late-stage clinical biopharmaceutical company, today announced topline data from the Phase 2/3 AUDREY™ clinical study evaluating voclosporin ophthalmic solution (VOS) for the potential treatment of dry eye syndrome (DES). The trial did not achieve statistical significance on its primary endpoint of a 10mm or greater improvement in STT at four weeks between active dose groups of…

    - The trial did not achieve statistical significance on the primary endpoint of ≥ 10mm improvement in Schirmer Tear Test (STT) at 4 weeks –

    - Company to suspend development program for voclosporin ophthalmic solution (VOS) -

    - Aurinia to host conference call today at 4:30 p.m. EST -

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) ("Aurinia" or the "Company"), a late-stage clinical biopharmaceutical company, today announced topline data from the Phase 2/3 AUDREY™ clinical study evaluating voclosporin ophthalmic solution (VOS) for the potential treatment of dry eye syndrome (DES). The trial did not achieve statistical significance on its primary endpoint of a 10mm or greater improvement in STT at four weeks between active dose groups of VOS compared to vehicle. Aurinia is suspending the development program for VOS based upon these results.

    "First and foremost, we would like to thank the patients and investigators who participated in the AUDREY clinical trial. Based upon these initial topline results that we continue to interrogate, we are suspending the DES program at this time," commented Peter Greenleaf, President and Chief Executive Officer of Aurinia. "While surprised by these results, we remain focused on preparing voclosporin for lupus nephritis – which has a different formulation and delivery mechanism compared to VOS. As we approach our lupus nephritis PDUFA action date, the Aurinia team remains committed to our mission of developing novel treatments for people with debilitating and severe autoimmune disease."

    The AUDREY trial was a randomized, double-masked, vehicle-controlled, dose-ranging study evaluating the efficacy and safety of VOS in subjects with DES. A total of 508 subjects were enrolled. The study consisted of four arms with a 1:1:1:1 randomization schedule, in which patients received either 0.2% VOS, 0.1% VOS, 0.05% VOS or vehicle, dosed twice daily for 12 weeks. The primary outcome measure for the trial was the proportion of subjects with a 10mm or greater improvement in STT at four weeks.

     

    Measure

    Result (%)

    Odds-Ratio

    (vs. vehicle)

    [95% CI]

    p-value

    (vs. vehicle)

    Primary

    Endpoint

    Percentage of patients

    with a ≥ 10mm

    improvement from

    baseline in a Schirmer

    Tear Test at 4 weeks

    VOS 0.05% =10%

    2.18 [0.62, 7.62]

    p = 0.09

    VOS 0.1% = 9%

    1.78 [0.49, 6.45]

    p = 0.28

    VOS 0.2% = 11%

    2.48 [0.70, 8.30]

    p = 0.13

    Vehicle = 5%

    N/A

    N/A

    "While we are understandably disappointed that VOS did not achieve the primary endpoint of the AUDREY trial, we uncovered important learnings about this disease state, particularly concerning the patient population with severe dry eye syndrome," commented Neil Solomons, M.D., Chief Medical Officer.

    Secondary outcome measures evaluated in the trial included STT at other time points, Fluorescein Corneal Staining (FCS) at multiple time points, change in eye dryness, burning/stinging, itching, photophobia, eye pain and foreign body sensation at multiple time points, and additional safety endpoints. Initial analysis of these secondary outcomes suggests dose-dependent activity and safety were observed across dose groups compared to vehicle. Further analysis of the AUDREY dataset will be conducted over the coming weeks.

    Conference Call Information

    Aurinia will host a conference call and webcast to discuss these results today, Monday, November 2, 2020 at 4:30 p.m. EST. The webcast can be accessed on the investor section of the Aurinia website at www.auriniapharma.com. To participate in the teleconference, please dial +1-877-407-9170 (Toll-free U.S. & Canada).

    About Aurinia

    Aurinia Pharmaceuticals is a late-stage clinical biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The Company is currently seeking FDA approval of voclosporin for the potential treatment of LN. The Company's head office is in Victoria, British Columbia and its U.S. commercial hub is in Rockville, Maryland. The Company focuses its development efforts globally.

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  38. Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (TSX:AUP) ("Aurinia" or the "Company"), a late-stage clinical biopharmaceutical company focused on advancing voclosporin across multiple indications, today announced the funding and initiation of an open-label exploratory trial evaluating the antiviral effects of voclosporin in kidney transplant recipients (KTRs) with COVID-19 (SARS-CoV-2) – the VOCOVID study. The single-center, investigator-initiated trial (IIT) is being conducted by Drs. Aiko P.J. de Vries and Y.K. Onno Teng at the Leiden University Medical Center (LUMC) in the Netherlands and will compare voclosporin against tacrolimus.

    "The COVID-19 pandemic has introduced new challenges for transplant recipients who require chronic immunosuppression…

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (TSX:AUP) ("Aurinia" or the "Company"), a late-stage clinical biopharmaceutical company focused on advancing voclosporin across multiple indications, today announced the funding and initiation of an open-label exploratory trial evaluating the antiviral effects of voclosporin in kidney transplant recipients (KTRs) with COVID-19 (SARS-CoV-2) – the VOCOVID study. The single-center, investigator-initiated trial (IIT) is being conducted by Drs. Aiko P.J. de Vries and Y.K. Onno Teng at the Leiden University Medical Center (LUMC) in the Netherlands and will compare voclosporin against tacrolimus.

    "The COVID-19 pandemic has introduced new challenges for transplant recipients who require chronic immunosuppression to maintain their transplanted organ, which puts them at high risk for a more severe course after contracting COVID-19," said Aiko P.J. de Vries, M.D. Ph.D., Department of Nephrology at LUMC.

    Onno Teng, MD, PhD, Department of Nephrology at the LUMC, commented, "we know from the previous PROMISE study that voclosporin can be dosed more predictably than legacy calcineurin inhibitors while maintaining the same degree of efficacy to prevent organ rejection. Preclinical data, which are being readied for peer-reviewed publication, from our institute in Leiden have demonstrated voclosporin's superior potency in vitro against SARS-CoV-2 compared to tacrolimus."

    Organ transplant recipients who contract COVID-19 are at greater risk for complications due to the requirement of daily immunosuppressive medications to prevent organ rejection. Calcineurin inhibitors (CNIs), like voclosporin, have been shown in prior in vitro studies to inhibit viral replication. The team at the LUMC demonstrated that voclosporin inhibited viral replication of SARS-CoV-2 at an 8-fold lower concentration than tacrolimus in vitro, while maintaining cell viability of infected cells. In contrast to voclosporin, tacrolimus did not show antiviral activity against SARS-CoV-2 in vitro at clinically relevant concentrations. Therefore, given its potency and dosing advantages, voclosporin is a potentially attractive CNI for COVID-19 infected transplant patients who are already using legacy CNIs as part of their chronic immunosuppressive therapy.

    "At Aurinia, we are dedicated to addressing the needs of people affected by serious diseases through scientifically rigorous and responsible drug development. Working with our long-time collaborators at LUMC, we established the preclinical antiviral activity of voclosporin against the SARS-CoV-2 virus with results that further highlight voclosporin's differentiation from legacy CNIs," stated Robert Huizinga, Ph.D., R.N., CNeph(C), Executive Vice President, Research at Aurinia. "As we continue to prepare for potential FDA approval and commercial launch of voclosporin for the treatment of LN, we are pleased to test the potential of voclosporin to meet the urgent needs of this specific patient population driven by the COVID-19 pandemic."

    About the VOCOVID Study

    This 56-day open-label investigator initiated trial (IIT) is designed to evaluate the antiviral effects of voclosporin compared to tacrolimus in stable kidney transplant recipients (KTRs) who contracted SARS-CoV-2. At study entry, 20 KTRs testing positive for SARS-CoV-2 and currently on dual immunosuppressives of prednisone and tacrolimus will be randomized 1:1 to remain on tacrolimus or be switched to voclosporin. The primary endpoint is the reduction in SARS-CoV-2 viral load over 56 days, as measured by reverse transcription polymerase chain reaction (qRT-PCR). The study will also assess predefined endpoints as surrogate markers of improved viral clearance including time to 3-log reduction in viral load concentration, time to clinical recovery – defined as free of symptoms for five days or more, and safety and tolerability. Following the 56-day treatment period, there will be an extended safety follow-up of voclosporin treated patients for up to one year.

    About Voclosporin

    Voclosporin is a novel calcineurin inhibitor (CNI) developed to treat patients with lupus nephritis. By inhibiting calcineurin, voclosporin blocks IL-2 expression and reduces T-cell mediated immune responses while it synergistically stabilizes podocytes in the kidney. This novel CNI has a favorable metabolic profile and a consistent, predictable dose response potentially eliminating the need for therapeutic drug monitoring.

    There are currently no therapies approved by the Food and Drug Administration (FDA) to treat lupus nephritis. Additionally, current SOC yields very low complete response rates. To help address the significant unmet medical need of lupus nephritis, the FDA designated voclosporin fast track status and priority review.

    Voclosporin is currently not approved by the US FDA for any indication.

    About Leiden University Medical Center

    As a centre of medical innovation, Leiden University Medical Centre (LUMC) strives for a (inter)nationally recognised leading role in improving the quality of healthcare. The core tasks of the LUMC are research, education, patient care, training and continuing education. The LUMC is part of the Dutch Federation of University Medical Centres (NFU). The NFU is an alliance of the eight university medical centres (UMCs) in the Netherlands.

    About Aurinia

    Aurinia Pharmaceuticals is a late-stage clinical biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The Company is currently seeking FDA approval of the investigational drug, voclosporin, for the potential treatment of lupus nephritis and evaluating voclosporin ophthalmic solution (VOS) in a Phase 2/3 study for the treatment of dry eye syndrome. The Company's head office is in Victoria, British Columbia and its U.S. commercial hub in Rockville, Maryland, focuses its development efforts globally.

    Forward-Looking Statements

    Certain statements made in this press release may constitute forward-looking information within the meaning of applicable Canadian securities law and forward-looking statements within the meaning of applicable United States securities law. These forward-looking statements or information include but are not limited to statements or information with respect to: Aurinia's focus on advancing voclosporin in multiple indications; Aurinia's belief that voclosporin is a potentially attractive CNI and could have significant potential protective benefits for COVID-19 infected transplant patients who are already using legacy CNIs as part of their chronic immunosuppressive therapy; the potential results of the trial to evaluate antiviral activity of voclosporin in kidney transplant recipients with COVID-19; Aurinia's plans related to FDA regulatory approval and commercial launch for the use of voclosporin in LN; that voclosporin is a potentially best-in-class CNI; Aurinia's expectation that upon regulatory approval, patent protection for voclosporin will be extended in the United States and certain other major markets, including Europe and Japan, until at least October 2027 under the Hatch-Waxman Act and comparable laws in other countries and until April 2028 with anticipated pediatric extension; and that a U.S. patent has also been issued covering the voclosporin dosing protocol with a term extending to December 2037, if the FDA incorporates the dosing protocol used in both the AURA and AURORA trials into the product label. Words such as "anticipate", "will", "believe", "estimate", "expect", "intend", "target", "plan", "goals", "objectives", "may" and other similar words and expressions, identify forward-looking statements. We have made numerous assumptions about the forward-looking statements and information contained herein, including among other things, assumptions about: the market value for the LN and DES programs; that another company will not create a substantial competitive product for Aurinia's LN and DES business without violating Aurinia's intellectual property rights; the burn rate of Aurinia's cash for operations; the costs and expenses associated with Aurinia's clinical trials; the planned studies achieving positive results; Aurinia being able to extend and protect its patents on terms acceptable to Aurinia; and the size of the LN, DES or proteinuric kidney disease markets; Aurinia will be able to obtain all necessary regulatory approvals for commercialization of voclosporin for use in LN on terms that are acceptable to it and that are commercially viable; and that Aurinia's intellectual property rights are valid and do not infringe the intellectual property rights of other parties. Even though the management of Aurinia believes that the assumptions made, and the expectations represented by such statements or information are reasonable, there can be no assurance that the forward-looking information will prove to be accurate.

    Forward-looking information by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aurinia to be materially different from any future results, performance or achievements expressed or implied by such forward-looking information. Should one or more of these risks and uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in forward-looking statements or information. Such risks, uncertainties and other factors include, among others, the following: difficulties, delays, or failures we may experience in the conduct of our clinical trial; difficulties we may experience in completing the development and commercialization of voclosporin; the market for the LN, DES and other proteinuric kidney disease business may not be as estimated; Aurinia may have to pay unanticipated expenses; estimated costs for clinical trials may be underestimated, resulting in Aurinia having to make additional expenditures to achieve its current goals; Aurinia not being able to extend or fully protect its patent portfolio for voclosporin; competitors may arise with similar products; Aurinia may not be able to obtain necessary regulatory approvals for commercialization of voclosporin in a timely fashion, or at all; Aurinia may not be able to obtain sufficient supply to meet commercial demand for voclosporin in a timely fashion; unknown impact and difficulties imposed by the COVID-19 pandemic on our business operations including nonclinical, clinical, regulatory and commercial activities; and our assets or business activities may be subject to disputes that may result in litigation or other legal claims. Although we have attempted to identify factors that would cause actual actions, events or results to differ materially from those described in forward-looking statements and information, there may be other factors that cause actual results, performances, achievements or events to not be as anticipated, estimated or intended. Also, many of the factors are beyond our control. There can be no assurance that forward-looking statements or information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, you should not place undue reliance on forward-looking statements or information.

    Except as required by law, Aurinia will not update forward-looking information. All forward-looking information contained in this press release is qualified by this cautionary statement. Additional information related to Aurinia, including a detailed list of the risks and uncertainties affecting Aurinia and its business can be found in Aurinia's most recent Annual Information Form available by accessing the Canadian Securities Administrators' System for Electronic Document Analysis and Retrieval (SEDAR) website at www.sedar.com or the U.S. Securities and Exchange Commission's Electronic Document Gathering and Retrieval System (EDGAR) website at www.sec.gov/edgar.

    We seek safe harbour.

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  39. - Integrated analysis confirms statistically superior efficacy and safety of voclosporin in combination with MMF and steroids over standard-of-care –

    - Voclosporin pharmacokinetic data supports consistent dose-response, potentially eliminating the need for therapeutic drug monitoring –

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) ("Aurinia" or the "Company"), a late-stage clinical biopharmaceutical company focused on advancing voclosporin across multiple indications, today announced that integrated efficacy and pharmacokinetic (PK) data from Aurinia's AURA-LV and AURORA pivotal trials of voclosporin in lupus nephritis (LN) were presented. The data were shared at the American Society of Nephrology (ASN) Kidney Week 2020 in presentations…

    - Integrated analysis confirms statistically superior efficacy and safety of voclosporin in combination with MMF and steroids over standard-of-care –

    - Voclosporin pharmacokinetic data supports consistent dose-response, potentially eliminating the need for therapeutic drug monitoring –

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) ("Aurinia" or the "Company"), a late-stage clinical biopharmaceutical company focused on advancing voclosporin across multiple indications, today announced that integrated efficacy and pharmacokinetic (PK) data from Aurinia's AURA-LV and AURORA pivotal trials of voclosporin in lupus nephritis (LN) were presented. The data were shared at the American Society of Nephrology (ASN) Kidney Week 2020 in presentations given by Brad Rovin, M.D., FASN, Director of Nephrology and Vice Chairman of Research for the Department of Internal Medicine at the Ohio State University Wexner Medical Center and Teun van Gelder, Professor in Clinical Pharmacology for the Department of Clinical Pharmacy and Toxicology at the Leiden University Medical Center.

    "People living with lupus nephritis are in a race against time to get their disease under control with the goal of improving their long term kidney health. We are pleased that the pooled analysis from our AURA-LV and AURORA pivotal trials further underscores voclosporin's potential as an important tool to help people quickly change the course of their disease," said Neil Solomons, M.D., Chief Medical Officer of Aurinia. "Together with the supportive pharmacokinetic data, these findings add to the growing body of information available on voclosporin as an investigational drug that could provide an important treatment approach for people dealing with LN."

    Data from a total of 534 patients from AURA-LV and AURORA was integrated and presented, demonstrating that 268 patients with LN treated with voclosporin in combination with mycophenolate mofetil (MMF) and low-dose steroids achieved statistically superior and faster Renal Response rates compared to 266 patients treated with MMF and steroids alone. The effects were also observed in Hispanic patients, a high-risk lupus nephritis population. Treatment with voclosporin resulted in clinically meaningful and a statistically significant higher Renal Response rate of 43.7% compared to 23.3% in the control arm at one year (OR 2.76, 95% CI: 1.88, 4.05; p < 0.0001) and at six months (voclosporin 31.7%; placebo 20.3%), [OR: 2.01; 95% CI: 1.34, 3.01; p=0.0008].

    The Company also presented PK data analyzed from the AURA-LV and AURORA studies further supporting the potential to eliminate the need for therapeutic drug monitoring. The influence of various covariates on voclosporin's PK was evaluated based on a population PK model and calcineurin inhibition was estimated using concentration data in the LN population and previously measured inhibition. At the recommended therapeutic dose of 23.7 mg twice daily, sex, body weight, race, age, serum albumin, total bilirubin and estimated glomerular filtration rate (eGFR) demonstrated no clinically relevant effect on voclosporin's PK parameters. Voclosporin was shown to inhibit calcineurin in a dose-dependent manner. In a quartile exposure analysis, no relationship with the odds ratio for renal response was observed and favored voclosporin in all quartiles. The linear PK profile of voclosporin allows the use of a pharmacodynamic approach instead of a pharmacokinetic approach, in which the dose of voclosporin is adjusted in response to decreases in eGFR.

    The AURA-LV and AURORA studies were of similar design and conducted in comparable patient populations. The data from both studies for subjects treated with the recommended voclosporin dose of 23.7 mg twice daily (AURORA; n=179, AURA-LV; n=89) or with matching placebo (AURORA; n= 178, AURA-LV; n=88) were therefore pooled for an integrated analysis.

    The data presented at ASN Kidney Week 2020 was submitted as part of voclosporin's new drug application (NDA) to the United States Food and Drug Administration (FDA). The FDA accepted the NDA, agreed to Priority Review, and has assigned a Prescription Drug User Fee Act (PDUFA) target action data of January 22, 2021.

    About Aurinia

    Aurinia Pharmaceuticals is a late-stage clinical biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The Company is currently seeking FDA approval of voclosporin for the potential treatment of LN and evaluating voclosporin ophthalmic solution in a Phase 2/3 study for the treatment of dry eye syndrome. The Company's head office is in Victoria, British Columbia and its U.S. commercial hub is in Rockville, Maryland. The Company focuses its development efforts globally.

    Forward-Looking Statements

    Certain statements made in this press release may constitute forward-looking information within the meaning of applicable Canadian securities law and forward-looking statements within the meaning of applicable United States securities law. These forward-looking statements or information include but are not limited to statements or information with respect to: the Company's belief that the voclosporin efficacy and PK data from the integrated analysis of the AURA-LV and AURORA studies supports consistent dose-response, has the potential to eliminate the need for therapeutic drug monitoring, underscores voclosporin as a potentially important tool to help people quickly change the course of their disease, and could provide an important treatment approach for people dealing with LN; the Company's PDUFA target action data of January 22, 2021; and the potential FDA approval of voclosporin as a potential treatment for LN. It is possible that such results or conclusions may change based on further analyses of these data. Words such as "anticipate", "will", "believe", "estimate", "expect", "intend", "target", "plan", "goals", "objectives", "may" and other similar words and expressions, identify forward-looking statements. We have made numerous assumptions about the forward-looking statements and information contained herein, including among other things, assumptions about: the market value for the LN and DES programs; that another company will not create a substantial competitive product for Aurinia's LN and DES business without violating Aurinia's intellectual property rights; the burn rate of Aurinia's cash for operations; the costs and expenses associated with Aurinia's clinical trials; the planned studies achieving positive results; Aurinia being able to extend and protect its patents on terms acceptable to Aurinia; and the size of the LN, DES or proteinuric kidney disease markets; Aurinia will be able to obtain all necessary regulatory approvals for commercialization of voclosporin for use in LN on terms that are acceptable to it and that are commercially viable; and that Aurinia's intellectual property rights are valid and do not infringe the intellectual property rights of other parties. Even though the management of Aurinia believes that the assumptions made, and the expectations represented by such statements or information are reasonable, there can be no assurance that the forward-looking information will prove to be accurate.

    Forward-looking information by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aurinia to be materially different from any future results, performance or achievements expressed or implied by such forward-looking information. Should one or more of these risks and uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in forward-looking statements or information. Such risks, uncertainties and other factors include, among others, the following: difficulties, delays, or failures we may experience in the conduct of our clinical trial; difficulties we may experience in completing the development and commercialization of voclosporin; the market for the LN, DES and other proteinuric kidney disease business may not be as estimated; Aurinia may have to pay unanticipated expenses; estimated costs for clinical trials may be underestimated, resulting in Aurinia having to make additional expenditures to achieve its current goals; Aurinia not being able to extend or fully protect its patent portfolio for voclosporin; competitors may arise with similar products; Aurinia may not be able to obtain necessary regulatory approvals for commercialization of voclosporin in a timely fashion, or at all; Aurinia may not be able to obtain sufficient supply to meet commercial demand for voclosporin in a timely fashion; the unknown impact and difficulties imposed by the COVID-19 pandemic on our business operations including nonclinical, clinical, regulatory and commercial activities; and our assets or business activities may be subject to disputes that may result in litigation or other legal claims.. Although we have attempted to identify factors that would cause actual actions, events or results to differ materially from those described in forward-looking statements and information, there may be other factors that cause actual results, performances, achievements or events to not be as anticipated, estimated or intended. Also, many of the factors are beyond our control. There can be no assurance that forward-looking statements or information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, you should not place undue reliance on forward-looking statements or information.

    Except as required by law, Aurinia will not update forward-looking information. All forward-looking information contained in this press release is qualified by this cautionary statement. Additional information related to Aurinia, including a detailed list of the risks and uncertainties affecting Aurinia and its business can be found in Aurinia's most recent Annual Information Form available by accessing the Canadian Securities Administrators' System for Electronic Document Analysis and Retrieval (SEDAR) website at www.sedar.com or the U.S. Securities and Exchange Commission's Electronic Document Gathering and Retrieval System (EDGAR) website at www.sec.gov/edgar.

    We seek safe harbour.

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  40. Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) ("Aurinia" or the "Company") today announced Time Is Nephrons, the first-ever lupus nephritis (LN) disease-state awareness campaign for healthcare professionals (HCPs). The initiative aims to highlight the importance of active screening for early diagnosis to potentially minimize the impact on kidney function and improve long-term outcomes for every patient with LN.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201014005164/en/

    "Unfortunately, for many patients, the signs of lupus nephritis are subtle, yet a single flare of LN can potentially shorten the life span of the kidney by decades. Our ongoing engagement with the lupus…

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) ("Aurinia" or the "Company") today announced Time Is Nephrons, the first-ever lupus nephritis (LN) disease-state awareness campaign for healthcare professionals (HCPs). The initiative aims to highlight the importance of active screening for early diagnosis to potentially minimize the impact on kidney function and improve long-term outcomes for every patient with LN.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201014005164/en/

    "Unfortunately, for many patients, the signs of lupus nephritis are subtle, yet a single flare of LN can potentially shorten the life span of the kidney by decades. Our ongoing engagement with the lupus nephritis community revealed a key role for Aurinia to help change the course of the patient journey by creating a comprehensive resource for healthcare professionals with the latest disease monitoring and management methods," said Neil Solomons, M.D., Chief Medical Officer at Aurinia Pharmaceuticals. "We are excited to launch the Time Is Nephrons initiative which, along with our patient-focused disease awareness campaigns, aims to enhance awareness and the outlook for patients in need."

    Lupus nephritis is one of the most serious complications of systemic lupus erythematosus (SLE) and is caused by an inflammation of the kidney leading to proteinuria. If left untreated, LN can lead to irreversible kidney damage, kidney failure, or even death. In patients with LN, renal damage may start prior to the first clinically detected episode; therefore, patients should be actively and routinely screened for signs of the disease. Patients with LN who achieve a complete response as measured by decreases in proteinuria and a urine protein-to-creatinine ratio (UPCR) of less than 0.5 gm/gm can achieve better long term kidney outcomes such as avoidance of kidney failure, dialysis, or need for transplantation.

    About Aurinia

    Aurinia Pharmaceuticals is a late-stage clinical biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The Company is currently seeking FDA approval of voclosporin for the potential treatment of lupus nephritis and evaluating voclosporin ophthalmic solution (VOS) in a Phase 2/3 study for the treatment of dry eye syndrome. The Company's head office is in Victoria, British Columbia, its U.S. commercial hub in Rockville, Maryland, and focuses its development efforts globally.

    Forward-Looking Statements

    Certain statements made in this press release may constitute forward-looking information within the meaning of applicable Canadian securities law and forward-looking statements within the meaning of applicable United States securities law. These forward-looking statements or information include but are not limited to statements or information with respect to: the aims of the initiative; the Company's goal of bringing the first dedicated therapeutic option for LN to patients and the potential FDA approval of voclosporin as a potential treatment for LN. It is possible that such results or conclusions may change based on further analyses of these data. Words such as "anticipate", "will", "believe", "estimate", "expect", "intend", "target", "plan", "goals", "objectives", "may" and other similar words and expressions, identify forward-looking statements. We have made numerous assumptions about the forward-looking statements and information contained herein, including among other things, assumptions about: the market value for the LN and DES programs; that another company will not create a substantial competitive product for Aurinia's LN and DES business without violating Aurinia's intellectual property rights; the burn rate of Aurinia's cash for operations; the costs and expenses associated with Aurinia's clinical trials; the planned studies achieving positive results; Aurinia being able to extend and protect its patents on terms acceptable to Aurinia; and the size of the LN, DES or proteinuric kidney disease markets; Aurinia will be able to obtain all necessary regulatory approvals for commercialization of voclosporin for use in LN on terms that are acceptable to it and that are commercially viable; and that Aurinia's intellectual property rights are valid and do not infringe the intellectual property rights of other parties. Even though the management of Aurinia believes that the assumptions made, and the expectations represented by such statements or information are reasonable, there can be no assurance that the forward-looking information will prove to be accurate.

    Forward-looking information by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Aurinia to be materially different from any future results, performance or achievements expressed or implied by such forward-looking information. Should one or more of these risks and uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in forward-looking statements or information. Such risks, uncertainties and other factors include, among others, the following: difficulties, delays, or failures we may experience in the conduct of our clinical trial; difficulties we may experience in completing the development and commercialization of voclosporin; the market for the LN, DES and other proteinuric kidney disease business may not be as estimated; Aurinia may have to pay unanticipated expenses; estimated costs for clinical trials may be underestimated, resulting in Aurinia having to make additional expenditures to achieve its current goals; Aurinia not being able to extend or fully protect its patent portfolio for voclosporin; competitors may arise with similar products; Aurinia may not be able to obtain necessary regulatory approvals for commercialization of voclosporin in a timely fashion, or at all; and Aurinia may not be able to obtain sufficient supply to meet commercial demand for voclosporin in a timely fashion. Although we have attempted to identify factors that would cause actual actions, events or results to differ materially from those described in forward-looking statements and information, there may be other factors that cause actual results, performances, achievements or events to not be as anticipated, estimated or intended. Also, many of the factors are beyond our control. There can be no assurance that forward-looking statements or information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, you should not place undue reliance on forward-looking statements or information.

    Except as required by law, Aurinia will not update forward-looking information. All forward-looking information contained in this press release is qualified by this cautionary statement. Additional information related to Aurinia, including a detailed list of the risks and uncertainties affecting Aurinia and its business can be found in Aurinia's most recent Annual Information Form available by accessing the Canadian Securities Administrators' System for Electronic Document Analysis and Retrieval (SEDAR) website at www.sedar.com or the U.S. Securities and Exchange Commission's Electronic Document Gathering and Retrieval System (EDGAR) website at www.sec.gov/edgar.

    We seek safe harbour.

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  41. Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (TSX:AUP) ("Aurinia" or the "Company"), a late-stage clinical biopharmaceutical company focused on advancing voclosporin in multiple indications, today announced that the Company's Compensation Committee granted 9 new employees non-qualified stock options to purchase an aggregate of 96,000 common shares, at a per share exercise price of $14.73 USD, the closing trading price on September 30, 2020. One-third of the options vest in October 2021, and the balance of the options vests in a series of 24 equal monthly installments thereafter. The inducement options were granted as an inducement material to the new employees entering into employment with Aurinia in accordance with Nasdaq Listing Rule 5635(c)(4…

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (TSX:AUP) ("Aurinia" or the "Company"), a late-stage clinical biopharmaceutical company focused on advancing voclosporin in multiple indications, today announced that the Company's Compensation Committee granted 9 new employees non-qualified stock options to purchase an aggregate of 96,000 common shares, at a per share exercise price of $14.73 USD, the closing trading price on September 30, 2020. One-third of the options vest in October 2021, and the balance of the options vests in a series of 24 equal monthly installments thereafter. The inducement options were granted as an inducement material to the new employees entering into employment with Aurinia in accordance with Nasdaq Listing Rule 5635(c)(4). For the purposes of TSX approval, the Company relied on the exemption set forth in Section 602.1 of the TSX Company Manual, which provides that the TSX will not apply its standards to certain transactions involving eligible inter-listed issuers on a recognized exchange, such as Nasdaq.

    The inducement stock options also have a ten year term and are subject to the terms and conditions of the stock option agreement pursuant to which the option was granted.

    About Aurinia

    Aurinia Pharmaceuticals is a late clinical-stage biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. The Company is currently developing an investigational drug, for the treatment of lupus nephritis and dry eye syndrome. The Company's head office is in Victoria, British Columbia and focuses its development efforts globally. For further information, see our website at www.auriniapharma.com.

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