1. 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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  2. - 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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  3. 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
  4. 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
  5. - 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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  6. 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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  7. - 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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  8. - 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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  9. 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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  10. 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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  11. 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

    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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  12. 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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  13. - 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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  14. - 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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  15. - 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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  16. 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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  17. - 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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  18. 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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  19. 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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  20. - Voclosporin ophthalmic solution (VOS) results on track to be reported in the fourth quarter of 2020 -

    - Study builds on positive head-to-head data with approved treatment reported in prior Phase 2a study -

    - Dry eye syndrome is a chronic autoimmune disorder affecting quality of life for millions in the U.S. -

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) (Aurinia or the Company), a late-stage clinical biopharmaceutical company focused on advancing voclosporin across multiple autoimmune conditions, today announced that the last patient study visit has occurred in the Phase 2/3 AUDREY™ clinical study evaluating voclosporin ophthalmic solution (VOS) for the potential treatment of dry eye syndrome (DES).

    "Despite the challenges posed…

    - Voclosporin ophthalmic solution (VOS) results on track to be reported in the fourth quarter of 2020 -

    - Study builds on positive head-to-head data with approved treatment reported in prior Phase 2a study -

    - Dry eye syndrome is a chronic autoimmune disorder affecting quality of life for millions in the U.S. -

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) (Aurinia or the Company), a late-stage clinical biopharmaceutical company focused on advancing voclosporin across multiple autoimmune conditions, today announced that the last patient study visit has occurred in the Phase 2/3 AUDREY™ clinical study evaluating voclosporin ophthalmic solution (VOS) for the potential treatment of dry eye syndrome (DES).

    "Despite the challenges posed by the ongoing viral pandemic, our clinical operations team at Aurinia has maintained executional excellence by completing the treatment phase of our major clinical trial assessing VOS in this common chronic autoimmune disorder, which affects more than 16 million people in the United States," said Peter Greenleaf, President and Chief Executive Officer of Aurinia. "Based upon the striking efficacy results observed with VOS in our head-to-head exploratory study against 0.05% cyclosporine, we are excited to see the results of this clinical trial which aims to fulfill a number of regulatory requirements typically required by the FDA for this indication."

    The AUDREY Phase 2/3 DES study is evaluating VOS via a randomized, double-masked, vehicle-controlled, dose ranging study evaluating efficacy and safety in subjects with DES compared to formulation. A total of 509 subjects were enrolled. The study consists of four arms with a 1:1:1:1 randomization schedule, 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 study is the proportion of subjects with a 10mm improvement in Schirmer's Tear Test (STT) at four weeks. Secondary outcome measures include STT at 12 weeks and 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, change in Symptom Assessment in Dry Eye (SANDE) score at multiple time points, and additional safety endpoints.

    In January of 2019, Aurinia reported that although VOS (voclosporin 0.2%) administered twice daily did not meet the primary endpoint of drop discomfort at one-minute, it was superior to Restasis® (0.05% cyclosporine A) administered twice daily in all objective endpoints including FCS and STT. This statistical superiority was seen as quickly as two weeks. Additionally, voclosporin was given at four times the dose of cyclosporine with no additional drop discomfort as measured by the drop discomfort scores at one and five minutes after application. Based on these data the Company has gained confidence that VOS represents a potential best-in-class calcineurin inhibitor in ophthalmic indications. This head-to-head study against the market leader was the first study that has ever shown treatment superiority vs. an active comparator in a double-blind randomized fashion.

    Top-line results from the AUDREY clinical study are expected to be reported during the fourth quarter of 2020.

    About voclosporin ophthalmic solution (VOS)

    VOS is an aqueous, preservative free nanomicellar solution intended for use in the treatment of DES. Voclosporin is a potentially best-in-class calcineurin inhibitor (CNI) that has been shown to have a more predictable pharmacokinetic and pharmacodynamic relationship, increase in potency (versus cyclosporine) and an improved metabolic profile compared to legacy CNIs. Calcineurin inhibition is a validated mechanism for the treatment of ocular surface diseases. Positive Phase 2 results demonstrated that VOS 0.2% administered twice daily was clinically and statistically superior to 0.05% cyclosporine A (Restasis®) administered twice daily across all objective endpoints over four weeks.

    About DES

    Dry eye syndrome (DES) is characterized by irritation and inflammation that occurs when the eye's tear film is compromised by reduced tear production, imbalanced tear composition, or excessive tear evaporation. The impact of DES ranges from subtle, yet constant eye irritation to significant inflammation and scarring of the eye's surface. Discomfort and pain resulting from DES can reduce quality of life and cause difficulty reading, driving, using computers and performing daily activities. DES is a chronic disease estimated to affect more than 16 million people in the United States. There are multiple FDA approved therapies for the treatment of dry eye; however, there is opportunity for potential improvements in the effectiveness, tolerability and onset of action.

    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 regarding: expected timing of top-line results from the AUDREY clinical trial during the fourth quarter of 2020; potential results from the AUDREY clinical trial replicating the efficacy measures observed in the exploratory Phase 2 VOS study in 2019; that DES is estimated to affect more than 16 million people in the United States; and voclosporin and VOS being potentially best-in-class CNIs; there is opportunity for potential improvements in the effectiveness, tolerability and onset of action in therapies to treat DES. 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: third party service providers and patients completing matters relating to the AUDREY clinical trial in a manner consistent with prior actions; the size of the DES market; the results of Aurinia's clinical trials being accurate. 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, delays, or failures we may experience in the conduct of our clinical trial; clinical trial results may not be accurate; we may not be able to reproduce the results of our Phase 2 clinical study for VOS in our AUDREY Phase 2/3 clinical trial; the size of the DES market in the United States may not be as large as estimated. 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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  21. Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) (the "Company") today announced that members of the senior management team will participate in fireside chats during the following upcoming virtual investor conferences:

    • H.C. Wainwright & Co. 22nd Annual Global Investment Conference on September 14, 2020 at 10:30 a.m. EDT. Register here
    • Cantor Virtual Global Healthcare Conference on September 16, 2020 at 4:00 p.m. EDT. Register here
    • Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on September 23, 2020 at 1:40 p.m. ET. Register here

    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…

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) (the "Company") today announced that members of the senior management team will participate in fireside chats during the following upcoming virtual investor conferences:

    • H.C. Wainwright & Co. 22nd Annual Global Investment Conference on September 14, 2020 at 10:30 a.m. EDT. Register here
    • Cantor Virtual Global Healthcare Conference on September 16, 2020 at 4:00 p.m. EDT. Register here
    • Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on September 23, 2020 at 1:40 p.m. ET. Register here

    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 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.

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  22. 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 105 new employees non-qualified stock options to purchase an aggregate of 530,000 common shares, at a per share exercise price of $14.83 USD, the closing trading price on August 31, 2020. One-third of the options vest in September 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 5653(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 105 new employees non-qualified stock options to purchase an aggregate of 530,000 common shares, at a per share exercise price of $14.83 USD, the closing trading price on August 31, 2020. One-third of the options vest in September 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 5653(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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  23. - U.S. Food & Drug Administration grants Priority Review for voclosporin and sets PDUFA date of January 22, 2021 -

    - Cash, cash equivalents and short term investments totaled approximately $442.06 million at July 31, 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 second quarter ended June 30, 2020 and provided an update on recent operational highlights.

    "The acceptance of the voclosporin NDA is a significant step towards our goal of delivering the first FDA-approved therapy specifically for people living with lupus nephritis," commented Peter Greenleaf, President and Chief Executive Officer…

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

    - Cash, cash equivalents and short term investments totaled approximately $442.06 million at July 31, 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 second quarter ended June 30, 2020 and provided an update on recent operational highlights.

    "The acceptance of the voclosporin NDA is a significant step towards our goal of delivering the first FDA-approved therapy specifically for people living with lupus nephritis," commented Peter Greenleaf, President and Chief Executive Officer of Aurinia. "These people suffer from a debilitating, progressive condition that, if not adequately or quickly controlled, leads to life-threatening end-stage renal disease. Despite its high healthcare burden, lupus nephritis has no approved treatments in the United States which we believe has contributed to low awareness of this condition. Aurinia feels the urgency of its mission to change the course of lupus nephritis for this community in need, by combining deep engagement and advocacy efforts with truly innovative medical science."

    In addition to preparing for the launch of voclosporin for use as a potential treatment for lupus nephritis (LN), Aurinia continues to explore voclosporin in other proteinuric kidney indications and expects to provide an update on a planned clinical development program later this year. The Company's development of voclosporin ophthalmic solution (VOS) for dry eye syndrome (DES) remains on track to report topline results from its Phase 2/3 AUDREYTM dose-ranging trial during the fourth quarter of 2020.

    Max Colao, Chief Commercial Officer of Aurinia, commented, "As we make progress on our regulatory submission, we're rapidly building a world class commercial team that is fully resourced and committed to engaging the lupus nephritis community and healthcare professionals. Our strategy for a successful U.S. launch will be executed by deeply experienced Aurinia specialists and led by a proven leadership team. We are driven to make a difference in the lives of the lupus nephritis patients and our team will be launch ready in advance of our PDUFA date of January 22, 2021."

    Second Quarter 2020 Highlights

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

    In July 2020 the Company announced that the U.S. Food & Drug Administration (FDA) has accepted the filing of its New Drug Application (NDA) for voclosporin, as a potential treatment for LN. The FDA has granted Priority Review for the NDA, which provides an expedited six-month review, and has assigned a Prescription Drug User Fee Act (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.

    Further supportive data from AURORA pivotal study presented at scientific conferences

    The Company presented additional safety data and subgroup analyses from the completed AURORA pivotal trial of voclosporin at two scientific meetings during the quarter: the European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) 2020 Virtual Congress and the European League Against Rheumatism (EULAR) 2020 E-Congress. The data further supported the safety profile of voclosporin on an additional measure of kidney function and its clinically meaningful benefits for trial participants across ethnicities and self-reported race. These data were notable for further adding to the evidence supporting voclosporin's benefit over the standard-of-care with no apparent safety penalty, and its potential to deliver equal clinical benefits for patients of ethnicities or self-reported races disproportionately affected by lupus nephritis.

    Phase 2/3 AUDREY™ Phase 2/3 Clinical Trial of VOS

    In June 2020, Aurinia announced it had completed enrollment for the Phase 2/3 AUDREYTM clinical trial evaluating voclosporin ophthalmic solution (VOS) for the potential treatment of DES, a chronic disease estimated to affect more than 16 million people in the United States.

    The AUDREYTM trial is a randomized, double-masked, vehicle-controlled, dose-ranging study evaluating the efficacy and safety of VOS in subjects with DES. A total of 509 subjects have been enrolled and randomized into one of four arms with a 1:1:1:1 randomization schedule, in which patients receive either VOS 0.2%, VOS 0.1%, VOS 0.05% or vehicle, dosed twice daily for 12 weeks. The primary outcome measure for the trial is the proportion of subjects with a 10mm or greater improvement in the Schirmer Tear Test (STT) at four weeks. Secondary outcome measures will include 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. AUDREYTM builds on positive exploratory Phase 2 results demonstrating that 0.2% VOS administered twice daily was superior to cyclosporin A 0.05% (Restasis®) administered twice daily across all objective endpoints. Top-line results from the AUDREYTM clinical study are anticipated during the fourth quarter of 2020.

    Recent Director and Officer Appointments

    Appointment of Timothy P. Walbert to the Board

    On April 20, 2020, Aurinia announced the appointment of Mr. Walbert to the Board of Directors. Mr. Walbert has nearly 30 years of experience commercializing pharmaceutical products. Mr. Walbert is currently Chairman, President and Chief Executive Officer of Horizon Therapeutics plc. He also served as President, Chief Executive Officer and Director of IDM Pharma, Inc., a public biopharmaceutical company which was acquired by Takeda.

    Appointment of Joe Miller as Chief Financial Officer

    On April 27, Aurinia appointed Mr. Miller as Chief Financial Officer following the retirement of Mr. Dennis Bourgeault, who served in that role since 1998. Mr. Miller will be responsible for developing and leading the Company's financial operations to effectively support the Company's rapid growth.

    Financial Liquidity at June 30, 2020 and July Public Offering of Common Shares

    All amounts in this press release, unless specified otherwise, are expressed in U.S. dollars.

    As of June 30, 2020, Aurinia had cash, cash equivalents and short-term investments of $264.4 million compared to $286.1 million at March 31, 2020 and $306 million at December 31, 2019. Net cash used in operating activities was $22.6 million for the second quarter ended June 30, 2020 compared to $13.3 million for the second quarter ended June 30, 2019.

    Following the recently completed $200 million public offering, which closed on July 27, 2020, the Company's cash, cash equivalents and short term investments totaled approximately $442.06 million at July 31, 2020. The Company believes that it has sufficient financial resources to fund its current plans, which include conducting its ongoing research and development (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.

    Financial Results for Three Months Ended June 30, 2020

    The Company reported a consolidated net loss of $29.5 million or $0.26 per Common Share for the second quarter ended June 30, 2020, as compared to a consolidated net loss of $15.9 million or $0.17 per Common Share for the second quarter ended June 30, 2019.

    The loss for the second quarter ended June 30, 2020 reflected an increase of $3.0 million in the estimated fair value of derivative warrant liabilities compared to a reduction of $625,000 in the estimated fair value of derivative warrant liabilities for the second quarter ended June 30, 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 $26.6 million for the second quarter ended June 30, 2020 compared to $16.5 million for the same period in 2019.

    R&D expenses decreased to $11.1 million for the second quarter ended June 30, 2020 compared to $11.2 million for the second quarter ended June 30, 2019. The decrease in these expenses primarily reflected higher costs related to the preparation of the NDA submission and related supporting activities, the ongoing VOS Phase 2/3 AUDREYTM trial, the AURORA 2 extension trial and the expansion of the medical affairs team to support the launch of voclosporin partially offset by lower AURORA trial costs as this trial is now complete. Non-cash stock compensation expense charged to R&D also increased to $1.1 million for the second quarter ended June 30, 2020 compared to $749,000 for the comparable period in 2019 reflecting the hiring of a significant number of personnel in 2020 and an increase in the fair value of the stock options granted due to the increase in the Company's share price.

    Corporate, administration and business development expenses increased to $15.5 million for the second quarter of 2020 compared to $4.9 million for the second quarter of 2019. These expenses included the expansion of the commercial team, higher consulting and professional fees, insurance costs, and personnel compensation costs as the corporate organization buildout continued in the second quarter of 2020. Non-cash stock compensation expense charged to corporate, administration and business development also increased to $3.1 million for the second quarter ended June 30, 2020 compared to $1.2 million for the comparable period in 2019 reflecting the hiring of a significant number of personnel in 2020 and an increase in the fair value of the stock options granted due to the increase in the Company's share price.

    Financial Results for Six Months Ended June 30, 2020

    For the six months ended June 30, 2020, Aurinia reported a consolidated net loss of $46.1 million or $0.41 per Common Share compared to a consolidated net loss of $28.3 million or $0.31 per common share for the comparable period in 2019.

    R&D expenses were $24.9 million for the six months ended June 30, 2020 compared to $21.8 million for the same period in 2019. The increase in these expenses reflected higher costs incurred for the AURORA 2 extension trial, and preparation costs associated with the LN NDA submission partially offset by lower AURORA trial costs as this trial is now complete.

    Corporate, administration and business development expenses were $26.6 million for the six months ended June 30, 2020 compared to $8.8 million for the same period in 2019. The increase reflects the same items as noted in the second quarter corporate, administration and business development expenses.

    Non-cash stock compensation expense totaled $7.7 million for the six months ended June 30, 2020 as compared with $3.6 million for the same period in 2019 and is included in both research and development and corporate, general and business development expenses.

    For the six months ended June 30, 2020 Aurinia recorded a decrease of $6.9 million in the estimated fair value of derivative warrant liabilities compared to a decrease of $2.4 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 second quarter ended June 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 second quarter ended June 30, 2020 financial results today, Tuesday, August 11, 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 seeking FDA approval of voclosporin for the potential treatment of lupus nephritis (Anticipated PDUFA date: January 22, 2021) 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 potential FDA 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 expectation that is tracking well for launch readiness in advance of the Company's PDUFA date of January 22, 2021; the Company's anticipated PDUFA date of January 22, 2021; the Company's expectation that the top-line results from the Phase 2/3 AUDREYTM dose-ranging trial of VOS will be released during the fourth quarter of 2020; the Company's belief that it has sufficient cash resources to adequately fund its plans which include conducting its ongoing R&D programs, 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 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; 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 or DES 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 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 and DES 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)

     

    June 30,

    2020

    $

     

    December 31,

    2019

    $

    Assets

     

     

     

    Cash, cash equivalents and short-term investments

    264,350

     

    306,019

    Accrued interest and other receivables

    508

     

    368

    Prepaid expenses, deposits and other

    13,161

     

    8,750

     

    278,019

     

    315,137

     

     

     

     

    Clinical trial contract deposits

    209

     

    209

    Acquired intellectual property and other intangible assets

    10,627

     

    11,244

    Property and equipment

    6,423

     

    93

     

    295,278

     

    326,683

     

     

     

     

    Liabilities and Shareholders' Equity

     

     

     

    Accounts payable and accrued liabilities

    13,641

     

    11,177

    Other current liabilities

    3,502

     

    118

     

    17,143

     

    11,295

     

     

     

     

    Derivative warrant liabilities

    22,451

     

    29,353

    Other non-current liabilities

    16,645

     

    12,519

     

    56,239

     

    53,167

     

     

     

     

    Shareholders' equity

    239,039

     

    273,516

    Total liabilities and shareholders' equity

    295,278

     

    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

    Six months ended

    June 30, 2020

    June 30, 2019

    June 30, 2020

    June 30, 2019

    $

    $

    $

    $

    Revenue

    Licensing revenue

    29

    29

    59

    59

     

     

     

     

    Expenses

    Research and development

    11,076

    11,152

    24,911

    21,783

    Corporate, administration and business development

    15,541

    4,946

    26,602

    8,847

    Amortization of acquired intellectual property and other intangible assets

    348

    347

    696

    693

    Amortization of property and equipment

    145

    38

    200

    75

    Other expenses

    (287)

    833

    1,925

    888

    26,823

    17,316

    54,334

    32,286

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

    (26,794)

    (17,287)

    (54,275)

    (32,227)

    Interest income

    320

    787

    1,211

    1,598

    Finance costs

    (78)

    (10)

    (103)

    (21)

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

    (26,552)

    (16,510)

    (53,167)

    (30,650)

    Change in estimated fair value of derivative warrant liabilities

    (2,952)

    625

    6,893

    2,350

     

     

     

     

    Loss before income taxes

    (29,504)

    (15,885)

    (46,274)

    (28,300)

    Income tax expense (recovery)

    22

    16

    (214)

    29

    Net loss and comprehensive loss for the period

    (29,526)

    (15,901)

    (46,060)

    (28,329)

     

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

    Basic and diluted loss per Common Share

    (0.26)

    (0.17)

    (0.41)

    (0.31)

     

     

     

     

    Weighted average number of Common Shares outstanding

    112,576

    91,768

    112,392

    90,961

     

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  24. Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) (the "Company") today announced that Peter Greenleaf, President and Chief Executive Officer of Aurinia, will participate in a fireside chat at the BTIG Virtual Biotechnology Conference on Monday, August 10, 2020 at 11:00 a.m. EDT.

    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 late-stage clinical biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are impacted…

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) (the "Company") today announced that Peter Greenleaf, President and Chief Executive Officer of Aurinia, will participate in a fireside chat at the BTIG Virtual Biotechnology Conference on Monday, August 10, 2020 at 11:00 a.m. EDT.

    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 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 (Anticipated PDUFA date: January 22, 2021) 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.

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  25. Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) (the "Company") today announced that it will release its second quarter 2020 financial results on Tuesday, August 11, 2020, after the markets close. Aurinia's executive 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 4:30 pm EDT on August 11, 2020. 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 Inc. (NASDAQ:AUPH, TSX:AUP) (the "Company") today announced that it will release its second quarter 2020 financial results on Tuesday, August 11, 2020, after the markets close. Aurinia's executive 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 4:30 pm EDT on August 11, 2020. 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 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 treatment of lupus nephritis (PDUFA date: January 22, 2021) 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.

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  26. 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 the closing of its previously announced underwritten public offering of 13,333,334 common shares (the "Offering"). The shares were sold at a public offering price of US$15.00 per share. The gross offering proceeds to the Company from this Offering are approximately US$200 million, before deducting underwriting discounts and commissions and other offering expenses.

    Jefferies and SVB Leerink acted as joint book-running managers for the Offering. Cantor acted as lead manager and Oppenheimer & Co. and H.C. Wainwright & Co. acted as co-managers…

    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 the closing of its previously announced underwritten public offering of 13,333,334 common shares (the "Offering"). The shares were sold at a public offering price of US$15.00 per share. The gross offering proceeds to the Company from this Offering are approximately US$200 million, before deducting underwriting discounts and commissions and other offering expenses.

    Jefferies and SVB Leerink acted as joint book-running managers for the Offering. Cantor acted as lead manager and Oppenheimer & Co. and H.C. Wainwright & Co. acted as co-managers for the Offering. The Company has granted the underwriters an option exercisable, in whole or in part, in the sole discretion of the underwriters, to purchase 2,000,000 additional common shares, for a period of up to 30 days.

    For the purposes of the 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 Company intends to use the net proceeds of the Offering for pre-commercialization and launch activities, research and development, as well as working capital and general corporate purposes.

    The Offering was made pursuant to a U.S. registration statement on Form F-10, declared effective by the U.S. Securities and Exchange Commission (the "SEC") on June 19, 2020 (the "Registration Statement"), and the Company's existing Canadian short form base shelf prospectus (the "Base Shelf Prospectus") dated June 17, 2020. The prospectus supplements relating to the Offering (together with the Base Shelf Prospectus and the Registration Statement, the "Offering Documents") have been filed with the securities commissions in the provinces of British Columbia, Alberta and Ontario in Canada, and with the SEC in the United States. The Offering Documents contain important detailed information about the securities being offered. Before you invest, you should read the Offering Documents and the other documents the Company has filed for more complete information about the Company and the Offering. Copies of the Offering Documents are available for free by visiting the Company's profiles on the SEDAR website maintained by the Canadian Securities Administrators at www.sedar.com or the SEC's website at www.sec.gov, as applicable. Alternatively, copies of the prospectus supplement are available upon request in the United States by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022; by phone at (877) 821-7388; or by e-mail at ; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 1-800-808-7525, ext. 6218, or by email at ; and in Canada by contacting Jefferies Securities, Inc., attention: Steven Latimer, 161 Bay Street, Suite 2700 Toronto, Ontario M5J 2S1, by telephone at 416-572-2215.

    This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, nor will there be any sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

    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, other proteinuric diseases and 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.

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  27. 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 the pricing of its underwritten public offering of 13,333,334 common shares (the "Offering"). The shares are being sold at a public offering price of US$15.00 per share. The gross offering proceeds to the Company from this Offering are expected to be approximately US$200 million, before deducting underwriting discounts and commissions and other offering expenses. All of the shares are being offered by the Company. The Offering is expected to close on or about July 27, 2020, subject to the satisfaction of customary closing conditions.

    Jefferies…

    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 the pricing of its underwritten public offering of 13,333,334 common shares (the "Offering"). The shares are being sold at a public offering price of US$15.00 per share. The gross offering proceeds to the Company from this Offering are expected to be approximately US$200 million, before deducting underwriting discounts and commissions and other offering expenses. All of the shares are being offered by the Company. The Offering is expected to close on or about July 27, 2020, subject to the satisfaction of customary closing conditions.

    Jefferies and SVB Leerink are acting as joint book-running managers for the Offering. Cantor is acting as lead manager for the Offering. Oppenheimer & Co. and H.C. Wainwright & Co. are acting as co-managers for the Offering. The Company has granted the underwriters an option exercisable, in whole or in part, in the sole discretion of the underwriters, to purchase 2,000,000 additional common shares, for a period of up to 30 days.

    The Company intends to use the net proceeds of the Offering for pre-commercialization and launch activities, research and development, as well as working capital and general corporate purposes.

    The Offering is subject to customary closing conditions, including NASDAQ and TSX approvals. For the purposes of the TSX approval, the Company intends to rely 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 interlisted issuers on a recognized exchange, such as NASDAQ.

    The Offering is being made pursuant to a U.S. registration statement on Form F-10, declared effective by the U.S. Securities and Exchange Commission (the "SEC") on June 19, 2020 (the "Registration Statement"), and the Company's existing Canadian short form base shelf prospectus (the "Base Shelf Prospectus") dated June 17, 2020. A preliminary prospectus supplement relating to the Offering has been filed with the securities commissions in the provinces of British Columbia, Alberta and Ontario in Canada, and with the SEC in the United States (the "Preliminary Prospectus"), and a final prospectus supplement relating to the Offering (together with the Preliminary Prospectus, Base Shelf Prospectus and the Registration Statement, the "Offering Documents") will be filed with the securities commissions in the provinces of British Columbia, Alberta and Ontario in Canada, and with the SEC in the United States. The Offering Documents will contain important detailed information about the securities being offered. Before you invest, you should read the Offering Documents and the other documents the Company has filed for more complete information about the Company and the Offering. Copies of the Offering Documents will be available for free by visiting the Company's profiles on the SEDAR website maintained by the Canadian Securities Administrators at www.sedar.com or the SEC's website at www.sec.gov, as applicable. Alternatively, copies of the prospectus supplement will be available upon request in the United States by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022; by phone at (877) 821-7388; or by e-mail at ; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 1-800-808-7525, ext. 6218, or by email at ; and in Canada by contacting Jefferies Securities, Inc., attention: Steven Latimer, 161 Bay Street, Suite 2700 Toronto, Ontario M5J 2S1, by telephone at 416-572-2215.

    This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, nor will there be any sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

    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, other proteinuric diseases and 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.

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  28. 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 it has commenced a registered underwritten public offering of its common shares (the "Offering").

    Jefferies and SVB Leerink are acting as joint book-running managers for the Offering.

    The Company will grant the underwriters an option exercisable, in whole or in part, in the sole discretion of the underwriters, to purchase up to an additional 15% of common shares, for a period of up to 30 days. The Offering is subject to market conditions, and there can be no assurance as to whether or when the Offering may be completed, or as to the…

    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 it has commenced a registered underwritten public offering of its common shares (the "Offering").

    Jefferies and SVB Leerink are acting as joint book-running managers for the Offering.

    The Company will grant the underwriters an option exercisable, in whole or in part, in the sole discretion of the underwriters, to purchase up to an additional 15% of common shares, for a period of up to 30 days. The Offering is subject to market conditions, and there can be no assurance as to whether or when the Offering may be completed, or as to the actual size or terms of the Offering.

    The Company intends to use the net proceeds of the Offering for pre-commercialization and launch activities, research and development, as well as working capital and general corporate purposes.

    The Offering is subject to customary closing conditions, including NASDAQ and TSX approvals. For the purposes of the TSX approval, the Company intends to rely 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 interlisted issuers on a recognized exchange, such as NASDAQ.

    The Offering is being made pursuant to a U.S. registration statement on Form F-10, declared effective by the United States Securities and Exchange Commission (the "SEC") on June 19, 2020 (the "Registration Statement"), and the Company's existing Canadian short form base shelf prospectus (the "Base Shelf Prospectus") dated June 17, 2020. The prospectus supplements relating to the Offering (together with the Base Shelf Prospectus and the Registration Statement, the "Offering Documents") will be filed with the securities commissions in the provinces of British Columbia, Alberta and Ontario in Canada, and with the SEC in the United States. The Offering Documents will contain important detailed information about the securities being offered. Before you invest, you should read the Offering Documents and the other documents the Company has filed for more complete information about the Company and the Offering. Copies of the Offering Documents will be available for free by visiting the Company's profiles on the SEDAR website maintained by the Canadian Securities Administrators at www.sedar.com or the SEC's website at www.sec.gov, as applicable. Alternatively, copies of the prospectus supplement will be available upon request in the United States by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022; by phone at (877) 821-7388; or by e-mail at ; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 1-800-808-7525, ext. 6218, or by email at ; and in Canada by contacting Jefferies Securities, Inc., attention: Steven Latimer, 161 Bay Street, Suite 2700 Toronto, Ontario M5J 2S1, by telephone at 416-572-2215.

    This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, nor will there be any sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

    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, other proteinuric diseases and 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.

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  29. - FDA grants Priority Review and sets PDUFA date of January 22, 2021 -

    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 the U.S. Food and Drug Administration (FDA) has accepted the filing of its New Drug Application (NDA) for voclosporin, as a potential treatment for lupus nephritis (LN), a serious inflammation of the kidneys caused by the autoimmune disease systemic lupus erythematosus (SLE). The FDA has granted Priority Review for the NDA, which provides an expedited six month review, and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 22, 2021…

    - FDA grants Priority Review and sets PDUFA date of January 22, 2021 -

    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 the U.S. Food and Drug Administration (FDA) has accepted the filing of its New Drug Application (NDA) for voclosporin, as a potential treatment for lupus nephritis (LN), a serious inflammation of the kidneys caused by the autoimmune disease systemic lupus erythematosus (SLE). The FDA has granted Priority Review for the NDA, which provides an expedited six month review, and has assigned a Prescription Drug User Fee Act (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.

    "People living with LN are in need of an advanced therapy that quickly drives the disease into remission and mediates kidney damage," said Peter Greenleaf, President and Chief Executive Officer of Aurinia. "We will continue to collaborate with the FDA during their review process and in parallel build our commercial readiness for a potential approval and commercial launch in  the first quarter of 2021."

    Priority review is granted to therapies that the FDA determines have the potential to provide a significant improvement in the safety or effectiveness of the treatment, diagnosis or prevention of a serious condition. Under PDUFA, a Priority Review targets a review time of six months compared to a standard review time of 10 months. Voclosporin was also granted Fast Track designation by the FDA in 2016.

    The NDA for voclosporin is supported by data from a substantial global clinical program including two pivotal studies, Phase 3 AURORA and Phase 2 AURA-LV. Additional AURORA study data was recently presented at the EULAR and ERA-EDTA virtual conferences, which provided further supportive detail into pre-specified subgroup analyses and changes in kidney function.

    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. It has been shown to have 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 laws in other countries and until April 2028 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 Lupus Nephritis

    Lupus nephritis (LN) is an inflammation of the kidney caused by Systemic Lupus Erythematosus (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 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, other proteinuric diseases and 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, information or public presentations with respect to: voclosporin being a potential treatment for LN; a PDUFA target action date of January 22, 2021; that we will continue to collaborate with the FDA during their review process and in parallel build our commercial readiness for a potential approval and commercial launch in the first quarter of 2021; voclosporin being potentially a best-in-class CNI; 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 and until April 2028 with anticipated pediatric extension; 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 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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  30. - Voclosporin ophthalmic solution (VOS) results anticipated in the fourth quarter of 2020 –

    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 it has completed enrollment for the Phase 2/3 AUDREY™ clinical trial evaluating voclosporin ophthalmic solution (VOS) for the potential treatment of dry eye syndrome (DES), a chronic disease estimated to affect more than 16 million people in the United States.

    "Voclosporin's proven mechanism of action as a novel calcineurin inhibitor gives us confidence in its potential as a new option for combatting the autoimmune processes underlying dry eye…

    - Voclosporin ophthalmic solution (VOS) results anticipated in the fourth quarter of 2020 –

    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 it has completed enrollment for the Phase 2/3 AUDREY™ clinical trial evaluating voclosporin ophthalmic solution (VOS) for the potential treatment of dry eye syndrome (DES), a chronic disease estimated to affect more than 16 million people in the United States.

    "Voclosporin's proven mechanism of action as a novel calcineurin inhibitor gives us confidence in its potential as a new option for combatting the autoimmune processes underlying dry eye syndrome, which still negatively impacts quality of life for millions despite currently available therapies," said Peter Greenleaf, President and Chief Executive Officer of Aurinia. "Given the extraordinary events of 2020, I would like to sincerely thank the patients, investigators, and the entire Aurinia team that has made this milestone achievable. Following the remaining 12-week treatment period and closing out of clinical trial activities, we look forward to reporting data from this trial in the fourth quarter of this year."

    The AUDREY trial is a randomized, double-masked, vehicle-controlled, dose-ranging study evaluating the efficacy and safety of VOS in subjects with DES. A total of 509 subjects were enrolled and randomized into one of four arms with a 1:1:1:1 randomization schedule, in which patients receive either VOS 0.2%, VOS 0.1%, VOS 0.05% or vehicle, dosed twice daily for 12 weeks. The primary outcome measure for the trial is the proportion of subjects with a 10mm or greater improvement in Schirmer Tear Test (STT) at four weeks. Secondary outcome measures will include 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. Top-line results from the AUDREY clinical study are anticipated during the fourth quarter of 2020. AUDREY builds on positive exploratory Phase 2 results demonstrating that 0.2% VOS administered twice daily was superior to cyclosporin A 0.05% (Restasis®) administered twice daily across all objective endpoints.

    Discomfort and pain resulting from DES can reduce quality of life and cause difficulty reading, driving, using computers and performing daily activities. There are multiple FDA approved therapies for the treatment of dry eye; however, there remains significant opportunity for potential improvements in the effectiveness, tolerability and onset of action.

    About Voclosporin ophthalmic solution (VOS)

    Voclosporin ophthalmic solution (VOS) is an aqueous, preservative free nanomicellar solution intended for use in the treatment of DES. Voclosporin is a potentially best-in-class calcineurin inhibitor (CNI) that has been shown to have a more predictable pharmacokinetic and pharmacodynamic relationship, increase in potency (versus cyclosporin) and an improved metabolic profile compared to legacy CNIs. Calcineurin inhibition is a validated mechanism for the treatment of ocular surface diseases. Positive Phase 2 results demonstrated that VOS 0.2% administered twice daily was superior to cyclosporin A 0.05% (Restasis®) administered twice daily across all objective endpoints.

    About DES

    Dry eye syndrome (DES) is characterized by irritation and inflammation that occurs when the eye's tear film is compromised by reduced tear production, imbalanced tear composition, or excessive tear evaporation. The impact of DES ranges from subtle, yet constant eye irritation to significant inflammation and scarring of the eye's surface. Discomfort and pain resulting from DES can reduce quality of life and cause difficulty reading, driving, using computers and performing daily activities. DES is a chronic disease estimated to affect more than 16 million people in the United States. There are multiple FDA approved therapies for the treatment of dry eye; however, there is opportunity for potential improvements in the effectiveness, tolerability and onset of action.

    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, other proteinuric diseases and 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 Voclosporin's mechanism of action as a novel calcineurin inhibitor as a potential new option for combatting the autoimmune processes underlying dry eye syndrome; the reporting of data, including top-line, primary and secondary, from Phase 2/3 AUDREY in the fourth quarter of 2020; that such data builds on the positive phase 2 data; that dry eye syndrome (DES) is estimated to affect more than 16 million people in the United States; potential timeline challenges due to the COVID-19 pandemic; voclosporin being potentially a best-in-class CNI with robust intellectual property exclusivity; 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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  31. Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) ("Aurinia" or the "Company"), a late-stage clinical biopharmaceutical company focused on advancing voclosporin across multiple indications, announced that additional safety data from the completed AURORA pivotal trial of voclosporin were shared at the European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) 2020 Virtual Congress in an oral presentation given by nephrologist Dawn Caster, M.D., Assistant Professor of Medicine at the University of Louisville School of Medicine.

    The data showed that pre-specified confirmed estimated glomerular filtration rate (eGFR) decreases of over 30% were similar in both AURORA trial patient groups, with 10.1% reported in the voclosporin…

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) ("Aurinia" or the "Company"), a late-stage clinical biopharmaceutical company focused on advancing voclosporin across multiple indications, announced that additional safety data from the completed AURORA pivotal trial of voclosporin were shared at the European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) 2020 Virtual Congress in an oral presentation given by nephrologist Dawn Caster, M.D., Assistant Professor of Medicine at the University of Louisville School of Medicine.

    The data showed that pre-specified confirmed estimated glomerular filtration rate (eGFR) decreases of over 30% were similar in both AURORA trial patient groups, with 10.1% reported in the voclosporin group and 10.2% in the control arm (p=0.971). eGFR is a standard measure of kidney function. No clinically meaningful differences between the treatment (23.7 mg twice daily oral voclosporin) and control groups were seen at any timepoints in the study on this parameter or in serum creatinine levels, another biomarker for renal damage. All patients in the AURORA study were treated with mycophenolate (MMF) and a background of corticosteroids. MMF is considered the standard-of-care for lupus nephritis, although unapproved by the FDA for that use.

    "This important new aspect of the full AURORA results further adds to the existing dataset that shows voclosporin's benefit over the standard-of-care with no apparent safety penalty," said Neil Solomons, M.D., Chief Medical Officer of Aurinia. "Our deep analysis of the comprehensive voclosporin clinical program continues to illustrate its potential as a treatment for lupus nephritis. This data has been submitted to the FDA as part of voclosporin's recently completed New Drug Application."

    As previously reported, AURORA met its primary endpoint, achieving statistically superior Renal Response rates of 40.8% for voclosporin versus 22.5% for the control (OR 2.65, 95% CI; p < 0.001). The benefits of voclosporin were also seen for all prespecified hierarchical secondary endpoints, achieving statistical significance in favor of voclosporin for Renal Response at 24 weeks, Partial Renal Response at 24 and 52 weeks, time to achieve urinary protein-to-creatinine ratio (UCPR) ≤ 0.5, and time to 50% reduction in UPCR.

    Voclosporin was well tolerated with no unexpected safety signals. Serious adverse events (SAEs) were reported in 20.8% of voclosporin patients versus 21.3% in the control arm. Infection was the most commonly reported SAE with 10.1% of voclosporin patients versus 11.2% of patients in the control arm. Overall mortality in the trial was low, with six deaths observed; one in the voclosporin arm and five in the control group. Additionally, the voclosporin arm showed no significant decrease at week 52 in eGFR or increase in blood pressure, lipids or glucose, which are common adverse events associated with legacy calcineurin inhibitors (CNIs).

    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. It has been shown to have 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 laws in other countries and until April 2028 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 Lupus Nephritis

    Lupus nephritis (LN) is an inflammation of the kidney caused by Systemic Lupus Erythematosus (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 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, other proteinuric diseases and 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, information or public presentations with respect to: positive efficacy and safety results from the AURORA Phase 3 pivotal trial, the full AURORA dataset, additional safety data, voclosporin as having Statistical Superiority Over Standard of Care in Lupus Nephritis andvoclosporin's differentiation from legacy calcineurin inhibitors; completing NDA rolling submissions and filings in a quality, successful and timely manner; having the FDA accept the filing and grant Priority Review, shortening the review time to 8 months instead of 12; the potential for commercial launch of voclosporin for use in LN in 2021; efforts towards delivering the first FDA-approved treatment option for those affected by LN in the hope of changing the course of this disease; timeline challenges due to the COVID-19 outbreak; 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 and until April 2028 with anticipated pediatric extension; 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; that the results of the AURORA clinical study are pivotal and a potential game changer for LN patients; that voclosporin may be positioned to become the standard of care for people living with LN; that Aurinia will present AURORA study results at a future scientific conference during 2020. 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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  32. - All pre-specified subgroup analyses in the pivotal trial favored voclosporin over placebo -

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) ("Aurinia" or the "Company"), a late-stage clinical biopharmaceutical company focused on advancing voclosporin across multiple indications, announced that new subgroup analyses from the completed AURORA pivotal trial of voclosporin were presented. The data were shared today at the European League Against Rheumatism (EULAR) 2020 E-Congress in an oral presentation given by Cristina Arriens, M.D., M.S.C.S., Clinical Assistant Member of the Arthritis and Clinical Immunology Research Program at the Oklahoma Medical Research Foundation (OMRF).

    The presented data demonstrated clinically meaningful benefits…

    - All pre-specified subgroup analyses in the pivotal trial favored voclosporin over placebo -

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) ("Aurinia" or the "Company"), a late-stage clinical biopharmaceutical company focused on advancing voclosporin across multiple indications, announced that new subgroup analyses from the completed AURORA pivotal trial of voclosporin were presented. The data were shared today at the European League Against Rheumatism (EULAR) 2020 E-Congress in an oral presentation given by Cristina Arriens, M.D., M.S.C.S., Clinical Assistant Member of the Arthritis and Clinical Immunology Research Program at the Oklahoma Medical Research Foundation (OMRF).

    The presented data demonstrated clinically meaningful benefits of voclosporin for trial participants across ethnicities and self-reported race. Significant renal response rates were seen for Hispanic/Latino (p=0.0062, OR 3.45) patients in the voclosporin arm (38.6%) versus control arm (18.6%), as well as for non-Hispanic/Latino patients (p=0.0045, OR 2.29) in the voclosporin arm (41.8%) versus the control arm (24.6%). Furthermore, all other pre-specified subgroup analyses (age, sex, race, biopsy class, region, and prior mycophenolate mofetil use) favored voclosporin.

    "The robustness of renal response across race and ethnicity and the onset of voclosporin effect have the potential to change the natural course of this debilitating disease," stated Neil Solomons, M.D., Chief Medical Officer of Aurinia. "The treatment benefits observed across all clinically important subgroups further strengthens our confidence in voclosporin as a potential treatment for people living with lupus nephritis."

    As previously reported, AURORA met its primary endpoint, achieving statistically superior Renal Response rates of 40.8% for voclosporin vs. 22.5% for the control (OR 2.65, 95% CI; p < 0.001). The benefits of voclosporin were also seen for all prespecified hierarchical secondary endpoints, achieving statistical significance in favor of voclosporin for Renal Response at 24 weeks, Partial Renal Response at 24 and 52 weeks, time to achieve urinary protein-to-creatinine ratio (UCPR) ≤ 0.5, and time to 50% reduction in UPCR.

    Voclosporin was well tolerated with no unexpected safety signals. Serious adverse events (SAEs) were reported in 20.8% of voclosporin patients vs. 21.3% in the control arm. Infection was the most commonly reported SAE with 10.1% of voclosporin patients versus 11.2% of patients in the control arm. Overall mortality in the trial was low, with six deaths observed; one in the voclosporin arm and five in the control group. Additionally, the voclosporin arm showed no significant decrease at week 52 in estimated glomerular filtration rate (eGFR) or increase in blood pressure, lipids or glucose, which are common adverse events associated with legacy calcineurin inhibitors (CNIs).

    The data presented at EULAR 2020 was submitted as part of voclosporin's new drug application (NDA) to the United States Food and Drug Administration (FDA) which was completed on May 25, 2020.

    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. It has been shown to have 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 laws in other countries and until April 2028 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 Lupus Nephritis

    Lupus nephritis (LN) is an inflammation of the kidney caused by Systemic Lupus Erythematosus (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 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, other proteinuric diseases and 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: positive efficacy and safety results from the AURORA Phase 3 pivotal trial, including public presentations stating Voclosporin as having Statistical Superiority Over Standard of Care in Lupus Nephritis; completing NDA rolling submissions and filings in a quality, successful and timely manner; having the FDA accept the filing and grant Priority Review, shortening the review time to 8 months instead of 12; the potential for commercial launch of voclosporin for use in LN in 2021; efforts towards delivering the first FDA-approved treatment option for those affected by LN in the hope of changing the course of this disease; timeline challenges due to the COVID-19 outbreak; 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 and until April 2028 with anticipated pediatric extension; 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; that the results of the AURORA clinical study are pivotal and a potential game changer for LN patients; that voclosporin may be positioned to become the standard of care for people living with LN; that Aurinia will present AURORA study results at a future scientific conference during 2020. 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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  33. Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) ("Aurinia" or the "Company") is pleased to announce that the nine incumbent directors of the Company were elected at the Company's annual general meeting held on June 2, 2020 (the "Meeting").

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

    Nominee

    Votes For (%)

    Votes Withheld (%)

    Election of Directors

     

     

    George M. Milne

    82.49%

    17.51%

    Peter Greenleaf

    93.25%

    6.75%

    David R.W. Jayne

    99.41%

    0.59%

    Joseph P. Hagan

    88.55%

    11.45%

    Michael Hayden

    99.27%

    0.73%

    Daniel G. Billen

    99.59%

    0.41%

    R. Hector MacKay-Dunn

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) ("Aurinia" or the "Company") is pleased to announce that the nine incumbent directors of the Company were elected at the Company's annual general meeting held on June 2, 2020 (the "Meeting").

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

    Nominee

    Votes For (%)

    Votes Withheld (%)

    Election of Directors

     

     

    George M. Milne

    82.49%

    17.51%

    Peter Greenleaf

    93.25%

    6.75%

    David R.W. Jayne

    99.41%

    0.59%

    Joseph P. Hagan

    88.55%

    11.45%

    Michael Hayden

    99.27%

    0.73%

    Daniel G. Billen

    99.59%

    0.41%

    R. Hector MacKay-Dunn

    99.31%

    0.69%

    Jill Leversage

    99.70%

    0.30%

    Timothy P. Walbert

    76.23%

    23.77%

    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 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. It has been shown to have 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 laws in other countries and until April 2028 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 Lupus Nephritis

    Lupus nephritis ("LN") is an inflammation of the kidney caused by Systemic Lupus Erythematosus ("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 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, other proteinuric diseases and 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: proxy voting for incumbent directors, and other matters voted upon at the Company's Annual General Meeting and the posting thereof on SEDAR and EDGAR; positive efficacy and safety results from the AURORA Phase 3 pivotal trial; completing NDA rolling submissions and filings in a quality, successful and timely manner; having the FDA accept the filing and grant Priority Review, shortening the review time to 8 months instead of 12; the potential for commercial launch of voclosporin for use in LN in 2021; efforts towards delivering the first FDA‑approved treatment option for those affected by LN in the hope of changing the course of this disease; timeline challenges due to the COVID-19 outbreak; 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 and until April 2028 with anticipated pediatric extension; 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; that the results of the AURORA clinical study are pivotal and a potential game changer for LN patients; that voclosporin may be positioned to become the standard of care for people living with LN; that Aurinia will present AURORA study results at a future scientific conference during 2020. 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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  34. Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) (the "Company") today announced that Peter Greenleaf, President and Chief Executive Officer of Aurinia, will participate in a fireside chat during the 2020 Jefferies Virtual Healthcare Conference on Thursday, June 4, 2020 at 3:30 p.m. EDT.

    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 late-stage clinical biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that…

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) (the "Company") today announced that Peter Greenleaf, President and Chief Executive Officer of Aurinia, will participate in a fireside chat during the 2020 Jefferies Virtual Healthcare Conference on Thursday, June 4, 2020 at 3:30 p.m. EDT.

    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 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, other proteinuric kidney diseases and dry eye syndrome. Aurinia's head office is in Victoria, British Columbia, its U.S. commercial hub in Rockville, Maryland, and focuses its development efforts globally.

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  35. - Potential for voclosporin to become the first FDA-approved therapy for the treatment of lupus nephritis -

    - NDA Application supported by extensive global clinical program including the pivotal Phase 3 AURORA study and the pivotal Phase 2 AURA LV study -

    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 completion of the rolling submission of a New Drug Application ("NDA") to the United States Food and Drug Administration ("FDA") for voclosporin as a potential treatment for lupus nephritis ("LN"), a serious inflammation of the kidneys caused by the autoimmune disease systemic…

    - Potential for voclosporin to become the first FDA-approved therapy for the treatment of lupus nephritis -

    - NDA Application supported by extensive global clinical program including the pivotal Phase 3 AURORA study and the pivotal Phase 2 AURA LV study -

    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 completion of the rolling submission of a New Drug Application ("NDA") to the United States Food and Drug Administration ("FDA") for voclosporin as a potential treatment for lupus nephritis ("LN"), a serious inflammation of the kidneys caused by the autoimmune disease systemic lupus erythematosus ("SLE"). There are currently no FDA-approved treatments for LN. The NDA submission includes a request for Priority Review, which, if granted, would shorten the FDA's review of the NDA to eight months from the time of submission, versus a standard review timeline of 12 months.

    "LN is a severe and debilitating consequence of lupus, which can severely impact the quality of life of individuals struggling with this disease. The Aurinia team continues to work incredibly hard towards delivering the first FDA‑approved treatment option for those affected by LN in the hope of changing the course of this disease," said Peter Greenleaf, President and Chief Executive Officer of Aurinia. "Our extensive clinical program, including results from both the AURA and AURORA trials, provides strong support for the profile of voclosporin as a novel treatment for lupus nephritis, and we are rapidly advancing our U.S. commercial strategy and infrastructure to support a potential launch early next year."

    Lawrence Mandt, Senior Vice President of Quality and Regulatory Affairs, at Aurinia commented, "The excellent Phase 3 clinical results enabled the highly experienced Aurinia team to produce and submit a quality submission for voclosporin ahead of our projections. We now look forward to further dialogue in the coming months with the agency regarding acceptance of the filing and priority review, and a potential approval date in early 2021."

    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. It has been shown to have 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 laws in other countries and until April 2028 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 Lupus Nephritis

    Lupus nephritis ("LN") is an inflammation of the kidney caused by Systemic Lupus Erythematosus ("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 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, other proteinuric diseases and 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: positive efficacy and safety results from the AURORA Phase 3 pivotal trial, including public presentations stating Voclosporin as having Statistical Superiority Over Standard of Care in Lupus Nephritis; completing NDA rolling submissions and filings in a quality, successful and timely manner; having the FDA accept the filing and grant Priority Review, shortening the review time to 8 months instead of 12; the potential for commercial launch of voclosporin for use in LN in 2021; efforts towards delivering the first FDA‑approved treatment option for those affected by LN in the hope of changing the course of this disease; timeline challenges due to the COVID-19 outbreak; 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 and until April 2028 with anticipated pediatric extension; 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; that the results of the AURORA clinical study are pivotal and a potential game changer for LN patients; that voclosporin may be positioned to become the standard of care for people living with LN; that Aurinia will present AURORA study results at a future scientific conference during 2020. 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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  36. Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) (the "Company") today announced that Peter Greenleaf, President and Chief Executive Officer of Aurinia, will participate in a fireside chat during the 2020 RBC Capital Markets' Virtual Global Healthcare Conference on Tuesday, May 19, 2020 at 10:20 a.m. E.D.T.

    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 late-stage clinical biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient…

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) (the "Company") today announced that Peter Greenleaf, President and Chief Executive Officer of Aurinia, will participate in a fireside chat during the 2020 RBC Capital Markets' Virtual Global Healthcare Conference on Tuesday, May 19, 2020 at 10:20 a.m. E.D.T.

    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 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, proteinuric kidney diseases, and dry eye syndrome. The Company's head office is in Victoria, British Columbia and focuses its development efforts globally.

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  37. - Cash and cash equivalents totaled approximately $286 million at March 31, 2020 -

    - Rolling submission of voclosporin New Drug Application to the U.S. Food & Drug Administration remains on track for completion by the end of the second quarter 2020 –

    - Continued evolution into commercial-stage organization highlighted by the appointments of Timothy P Walbert to the Board, Max Colao as Chief Commercial Officer, and Joe Miller as Chief Financial Officer –

    - 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 first quarter ended March 31, 2020 and provided an update on recent operational highlights. Amounts…

    - Cash and cash equivalents totaled approximately $286 million at March 31, 2020 -

    - Rolling submission of voclosporin New Drug Application to the U.S. Food & Drug Administration remains on track for completion by the end of the second quarter 2020 –

    - Continued evolution into commercial-stage organization highlighted by the appointments of Timothy P Walbert to the Board, Max Colao as Chief Commercial Officer, and Joe Miller as Chief Financial Officer –

    - 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 first quarter ended March 31, 2020 and provided an update on recent operational highlights. Amounts, unless specified otherwise, are expressed in U.S. dollars.

    "We are fortunate that the global COVID-19 pandemic has had minimal impact on Aurinia's operations, and we have maintained our timelines to ensure the filing of the voclosporin NDA by the end of the second quarter and hopefully obtain approval in early 2021," commented Peter Greenleaf, President and Chief Executive Officer of Aurinia. "Following the positive AURORA data reported last December we have strengthened the balance sheet, added world-class commercial expertise including the appointments of Timothy, Max, and Joe, and on-boarded a group of extraordinarily talented commercial leaders and additional staff."

    Mr. Greenleaf further stated, "With the establishment of our commercial hub in Maryland, we're building and preparing for the U.S. launch of voclosporin as the first FDA-approved treatment for lupus nephritis. In addition, the VOS development program remains on target, and we anticipate reporting out top-line results from the Phase 2/3 AUDREY dose-ranging trial of VOS during the fourth quarter of this year."

    Dr. Neil Solomons, Chief Medical Officer of Aurinia commented, "With respect to FSGS, our exploratory study has been open for an extended period and due to the continued difficulty identifying and enrolling primary FSGS patients, we've decided to adjust our approach. We are preparing to evaluate voclosporin in other proteinuric kidney diseases, while continuing to support patients who have participated in the FSGS exploratory study. As we work to incorporate these broader populations further updates will be available later this year."

    First Quarter 2020 Highlights

    Pre-NDA Meeting with the U.S. Food & Drug Administration ("FDA") and Rolling New Drug Application ("NDA") Submission

    • Aurinia held a positive and successful Pre-NDA meeting with the FDA on February 25, 2020. The Company presented information about the safety and efficacy data to be included in the filing, reviewed the format and content of the planned application, and gained agreement on the rolling review plans for filing modules of the NDA. No obstacles were raised by FDA that would prevent submission of the complete NDA by the end of the second quarter as planned.
    • In March 2020, Aurinia filed the non-clinical module to the FDA followed by the chemistry, manufacturing and controls module in April 2020.
    • Aurinia remains on track to file the complete NDA to the FDA by the end of the second quarter of 2020.

    Recent Director and Officer Appointments

    Appointment of Timothy P. Walbert to the Board

    On April 20, Aurinia announced the appointment of Mr. Walbert to the Board of Directors. Mr. Walbert has nearly 30 years of experience commercializing pharmaceutical products. Mr. Walbert is currently chairman, president and chief executive officer of Horizon Therapeutics plc. He also served as president, chief executive officer and director of IDM Pharma, Inc., a public biopharmaceutical company which was acquired by Takeda.

    Appointment of Joe Miller as Chief Financial Officer

    On April 27, Aurinia appointed Mr. Miller as Chief Financial Officer following the retirement of Mr. Dennis Bourgeault, who served in that role since 1998. Mr. Miller will be responsible for developing and leading the Company's financial operations to effectively support the Company's rapid growth. Mr. Bourgeault will remain an advisor to the Company to assist with the transition.

    Appointment of Max Colao as Chief Commercial Officer and build out of world-class commercial team

    On February 25, 2020, Aurinia announced the appointment of Max Colao to the newly created position of Chief Commercial Officer. In addition, Aurinia has recruited an experienced team of leaders responsible for key commercial functions including sales, marketing, market access, and commercial operations.

    Financial Liquidity at March 31, 2020

    As of March 31, 2020, Aurinia had cash, cash equivalents and short-term investments of $286.1 million compared to $306 million as at December 31, 2019. Net cash used in operating activities was $22.7 million for the first quarter ended March 31, 2020 compared to $13.1 million for the first quarter ended March 31, 2019.

    The Company believes that it has sufficient financial resources to fund its current plans, which include conducting its ongoing research and development ("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 2021.

    Financial Results for the First Quarter Ended March 31, 2020

    The Company reported a consolidated net loss of $16.5 million or $0.15 per common share for the first quarter ended March 31, 2020, as compared to a consolidated net loss of $12.4 million or $0.14 per common share for the first quarter ended March 31, 2019.

    The loss for the first quarter ended March 31, 2020 reflected a reduction of $9.8 million in the estimated fair value of derivative warrant liabilities compared to a reduction of $1.7 million in the estimated fair value of derivative warrant liabilities for the first quarter ended March 31, 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 $26.6 million for the first quarter ended March 31, 2020 compared to $14.1 million for the same period in 2019.

    R&D expenses increased to $13.8 million for the first quarter ended March 31, 2020 compared to $10.6 million for the first quarter ended March 31, 2019. The increase in these expenses primarily reflected higher costs related to the preparation of the NDA submission and related supporting activities, the ongoing VOS Phase 2/3 AUDREY trial, the AURORA 2 extension trial and the expansion of the medical affairs team to support the launch of voclosporin. Non-cash stock compensation expense charged to R&D also increased to $1.2 million for the first quarter ended March 31, 2020 compared to $862,000 for the comparable period in 2019 reflecting the hiring of a significant number of personnel in 2020 and an increase in the fair value of the stock options granted due to the increase in the Company's share price.

    Corporate, administration and business development expenses increased to $11.1 million for the first quarter of 2020 compared to $3.9 million for the first quarter of 2019. These expenses included the expansion of the commercial team, higher consulting and professional fees, insurance costs, and personnel compensation costs as the corporate organization buildout continued in the first quarter of 2020. Non-cash stock compensation expense charged to corporate, administration and business development also increased to $2.3 million for the first quarter ended March 31, 2020 compared to $742,000 for the comparable period in 2019 reflecting the hiring of a significant number of personnel in 2020 and an increase in the fair value of the stock options granted due to the increase in the Company's share price.

    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 first quarter ended March 31, 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 first quarter ended March 31, 2020 financial results today, Thursday, May 14, 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"), dry eye syndrome ("DES") and proteinuric kidney diseases. 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 second 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 expectation that the top-line results from the Phase 2/3 AUDREY dose-ranging trial of VOS will be released during the fourth quarter of 2020; 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 2021; 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 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; 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 or DES 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 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 and DES 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)

     

    March 31,

    2020

    $

     

    December 31,

    2019

    $

    Assets

     

     

     

    Cash, cash equivalents and short-term investments

    286,120

     

    306,019

    Accrued interest and other receivables

    3,511

     

    368

    Prepaid expenses, deposits and other

    8,266

     

    8,750

     

    297,897

     

    315,137

     

     

     

     

    Clinical trial contract deposits

    209

     

    209

    Acquired intellectual property and other intangible assets

    10,944

     

    11,244

    Property and equipment

    5,922

     

    93

     

    314,972

     

    326,683

     

     

     

     

    Liabilities and Shareholders' Equity

     

     

     

    Accounts payable and accrued liabilities

    12,411

     

    11,177

    Other current liabilities

    1,767

     

    118

     

    14,178

     

    11,295

     

     

     

     

    Derivative warrant liabilities

    19,499

     

    29,353

    Other non-current liabilities

    17,887

     

    12,519

     

    51,564

     

    53,167

     

     

     

     

    Shareholders' equity

    263,408

     

    273,516

    Total liabilities and shareholders' equity

    314,972

    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 March 31,

     

     

    Three months ended March 31,

     

    2020

     

    2019

     

    $

     

    $

    Revenue

     

     

     

    Licensing revenue

    30

     

    30

     

     

     

     

    Expenses

     

     

     

    Research and development

    13,835

     

    10,631

    Corporate, administration and business development

    11,061

     

    3,901

    Amortization of acquired intellectual property and other intangible assets

    348

     

    346

    Amortization of property and equipment

    55

     

    37

    Other expenses

    2,212

     

    55

     

    27,511

     

    14,970

     

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

    (27,481)

     

    (14,940)

     

    Interest income

    891

     

    811

    Finance costs

    (25)

     

    (11)

     

    Loss before change in estimated fair value of

     

     

     

    derivative warrant liabilities and income taxes

    (26,615)

     

    (14,140)

     

    Change in estimated fair value of derivative

    warrant liabilities

    9,845

     

    1,725

     

     

     

     

    Loss before income taxes

    (16,770)

     

    (12,415)

    Income tax (recovery) expense

    (236)

     

    13

    Net loss and comprehensive loss for the period

    (16,534)

     

    (12,428)

     

     

     

     

    Net loss per common share (expressed in $ per share)

     

     

     

    Basic and diluted loss per common share

    (0.15)

     

    (0.14)

     

    Weighted average number of common shares outstanding

    112,209

     

    90,146

     

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  38. Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) (the "Company") today announced that it will release its first quarter 2020 financial results on Thursday, May 14, 2020, 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 May 14, 2020 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…

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) (the "Company") today announced that it will release its first quarter 2020 financial results on Thursday, May 14, 2020, 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 May 14, 2020 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 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, focal segmental glomerulosclerosis and dry eye syndrome. The Company's head office is in Victoria, British Columbia and focuses its development efforts globally.

    View Full Article Hide Full Article
  39. - Dennis Bourgeault to retire after more than 20 years with the company -

    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 the appointment of Joe Miller as Chief Financial Officer. Mr. Miller will be responsible for developing and leading the Company's financial operations to effectively support the Company's rapid growth. Dennis Bourgeault will be retiring from that role after serving the Company for more than two decades.

    Mr. Miller joins Aurinia with over two decades of experience as a senior executive managing financial operations and supporting enterprise growth in companies across…

    - Dennis Bourgeault to retire after more than 20 years with the company -

    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 the appointment of Joe Miller as Chief Financial Officer. Mr. Miller will be responsible for developing and leading the Company's financial operations to effectively support the Company's rapid growth. Dennis Bourgeault will be retiring from that role after serving the Company for more than two decades.

    Mr. Miller joins Aurinia with over two decades of experience as a senior executive managing financial operations and supporting enterprise growth in companies across the health sciences, biotech and pharmaceutical sectors. Most recently, he served as Chief Financial Officer, Principal Executive Officer, and Corporate Secretary at Cerecor, Inc. At Cerecor, he completed the acquisition of Ichorion Therapeutics, Inc., the purchase of Aevi Genomic Medicine, and facilitated a strategic transformation of the organization by leading the divestiture of the company's commercial portfolio in a transaction with Aytu BioScience, Inc. in 2019. Mr. Miller currently serves as a director on Cerecor's Board. Prior to Cerecor, Mr. Miller was the Vice President of Finance at Sucampo Pharmaceuticals, Inc., where he was responsible for building out the finance organization to effectively support the company's rapid growth, ultimately leading to the $1.2B merger with Mallinckrodt in early 2018. Prior to Sucampo, he served in various progressive finance and management roles at QIAGEN, Eppendorf and KPMG LLP. Mr. Miller received his B.S. in accounting from Villanova University and is a Certified Public Accountant.

    "I am thrilled to join Aurinia at this pivotal moment and during a period of immense growth and opportunity," said Mr. Miller. "Following the positive AURORA Phase 3 data and recent formation of Aurinia's U.S. commercial team, I look forward to facilitating continued momentum and financial strength as the team works to bring novel therapies to those living with serious autoimmune diseases."

    Mr. Miller will replace Mr. Bourgeault, who has served as the Company's CFO since 1998. Mr. Bourgeault will remain an advisor to the Company to assist with the transition.

    "Dennis has played an integral role in every phase of Aurinia's growth, dating back before the Company's merger with Isotechnika. On behalf of the entire team, I'd like to sincerely thank him for his tireless dedication to this organization and wish him all the best in retirement," said Peter Greenleaf, President and Chief Executive Officer of Aurinia. "We welcome Joe to help lead Aurinia's next phase of growth. His experience in building and executing financial strategies and his vision to support long-term growth will be instrumental as we work to reach our goals as an organization and create value for both patients and investors."

    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 ("LN"), focal segmental glomerulosclerosis ("FSGS") and dry eye syndrome ("DES"). 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.

    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 rapid and long-term growth, increase in growth, financial strength and momentum, positive AURORA Phase 3 data, voclosporin being a novel therapy having the potential to help people with serious autoimmune diseases, such as lupus nephritis, completing NDA priority review submissions in a successful and timely manner including the anticipated NDA filing during the first half of 2020; the potential for commercial launch of voclosporin for use in LN in 2021; and voclosporin being potentially a best-in-class CNI with robust intellectual property exclusivity. Words such as "anticipate", "will", "believe", "estimate", "expect", "intend", "target", "plan", "goals", "objectives", "may", "facilitate", 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, DES and FSGS programs; that another company will not create a substantial competitive product for Aurinia's LN, DES and FSGS 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 FSGS 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. 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"), a late-stage clinical biopharmaceutical company focused on advancing voclosporin in multiple indications, today announced the appointment of Timothy P. Walbert, chairman, president and chief executive officer (CEO) of Horizon Therapeutics plc, to the Company's Board of Directors.

    "We are fortunate to have Tim join us at this critical juncture as we advance voclosporin through the regulatory process and prepare for potential commercialization," commented Peter Greenleaf, President and Chief Executive Officer of Aurinia. "Having served as the CEO of public commercial-stage biotech firms, Tim brings a wealth of strategic experience built upon his past roles leading…

    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 the appointment of Timothy P. Walbert, chairman, president and chief executive officer (CEO) of Horizon Therapeutics plc, to the Company's Board of Directors.

    "We are fortunate to have Tim join us at this critical juncture as we advance voclosporin through the regulatory process and prepare for potential commercialization," commented Peter Greenleaf, President and Chief Executive Officer of Aurinia. "Having served as the CEO of public commercial-stage biotech firms, Tim brings a wealth of strategic experience built upon his past roles leading the global development and launch of multiple pharmaceutical products in the United States and internationally. We look forward to his insights and know he will add immense value as the newest member of our exceptional Board of Directors."

    Mr. Walbert has nearly 30 years of experience commercializing pharmaceutical products. Mr. Walbert is currently chairman, president and chief executive officer of Horizon Therapeutics plc. He also served as president, chief executive officer and director of IDM Pharma, Inc., a public biopharmaceutical company which was acquired by Takeda. Prior to IDM, Mr. Walbert was the executive vice president of commercial operations at NeoPharm, Inc. Prior to this he was the divisional vice president and general manager, immunology, at Abbott where he led the global development and launch of HUMIRA. Mr. Walbert also served as director, CELEBREX North America and arthritis team leader, Asia Pacific, Latin America and Canada at G.D. Searle & Company. Earlier in his career, he held sales and marketing roles with increasing responsibility at several multinational pharmaceutical companies including G.D. Searle, Merck & Co., Inc. and Wyeth. Mr. Walbert received his Bachelor of Arts in Business from Muhlenberg College, in Allentown, Pa.

    "Voclosporin has the potential to help many people living with debilitating diseases, such as lupus nephritis, and I look forward to working with the Board, Peter and Aurinia's leadership team to support the Company's efforts toward successfully commercializing this innovative therapy," added Mr. Walbert.

    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 ("LN"), focal segmental glomerulosclerosis ("FSGS") and dry eye syndrome ("DES"). 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.

    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: voclosporin having the potential to help people living with debilitating diseases, such as lupus nephritis, completing NDA priority review submissions in a successful and timely manner including the anticipated NDA filing during the first half of 2020; the potential for commercial launch of voclosporin for use in LN in 2021; 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 and until April 2028 with anticipated pediatric extension; 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; that the results of the AURORA clinical study are pivotal and a potential game changer for LN patients; that voclosporin may be positioned to become the standard of care for people living with LN; that Aurinia will present AURORA study results at a future scientific conference during 2020. 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, DES and FSGS programs; that another company will not create a substantial competitive product for Aurinia's LN, DES and FSGS 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 FSGS 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 FSGS 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. venBio Partners LLC today announced the closing of venBio Global Strategic Fund III ("venBio Fund III"), its third life sciences venture capital fund, exceeding its target and closing on approximately $394 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 pharmaceutical companies, corporate pensions, financial institutions, endowments and foundations, family offices and funds-of-funds.

    Led by Managing Partners Corey Goodman, Ph.D., Robert Adelman, M.D., and Aaron Royston, M.D., venBio Fund III will continue to invest primarily in therapeutics companies that are developing biopharmaceuticals for unmet medical needs…

    venBio Partners LLC today announced the closing of venBio Global Strategic Fund III ("venBio Fund III"), its third life sciences venture capital fund, exceeding its target and closing on approximately $394 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 pharmaceutical companies, corporate pensions, financial institutions, endowments and foundations, family offices and funds-of-funds.

    Led by Managing Partners Corey Goodman, Ph.D., Robert Adelman, M.D., and Aaron Royston, M.D., venBio Fund III will continue to invest primarily in therapeutics companies that are developing biopharmaceuticals for unmet medical needs. The venBio team typically leads or co-leads investments and takes an active role with each of their portfolio companies.

    "We are grateful for the tremendous support we have received from our current investors during this fundraise," said Dr. Adelman. "We appreciate their ongoing commitment and welcome the broad range of new top-tier investors who have joined them."

    "We remain committed to our founding strategy at venBio, namely to turn great science into impactful medicine," said Dr. Goodman. "Our investment thesis, regardless of stage of company, remains to look for investment opportunities with a 3- to 5-year time horizon."

    "In addition to generating strong financial returns, we're proud of the impact our portfolio companies have made on patients," said Dr. Royston. "We've actively helped build three companies that have developed approved drugs that are on the market today."

    In conjunction with the new fund, venBio has promoted Richard Gaster M.D., Ph.D., to Partner. Dr. Gaster was previously head of translational medicine at Pliant Therapeutics and a Senior Associate at Third Rock Ventures. Prior to Third Rock, he was a resident physician in Harvard's Plastic and Reconstructive Surgery Program and received his M.D. and Ph.D. degrees from Stanford University in the Medical Scientist Training Program.

    About venBio Partners

    Established in 2011, venBio Partners is a life science venture capital firm that focuses on novel therapeutics for unmet medical needs. Since inception, venBio has raised nearly $1 billion in capital commitments and has invested in 29 companies including venBio-founded Labrys Biologics (acquired by Teva), 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) and Akero Therapeutics (NASDAQ:AKRO). For more information, please visit www.venbio.com.

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  42. - Data to be shared as a late-breaking oral presentation during the live virtual NKF conference -

    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 clinical data from its AURORA Phase 3 trial will be highlighted in a late-breaking oral presentation during the National Kidney Foundation ("NKF") 2020 Spring Clinical Meetings, which will be held as a live-virtual meeting per recommendations by the Centers for Disease Control and Prevention ("CDC"). The AURORA pivotal trial evaluated voclosporin in combination with mycophenolate ("MMF") and low-dose corticosteroids for the treatment of…

    - Data to be shared as a late-breaking oral presentation during the live virtual NKF conference -

    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 clinical data from its AURORA Phase 3 trial will be highlighted in a late-breaking oral presentation during the National Kidney Foundation ("NKF") 2020 Spring Clinical Meetings, which will be held as a live-virtual meeting per recommendations by the Centers for Disease Control and Prevention ("CDC"). The AURORA pivotal trial evaluated voclosporin in combination with mycophenolate ("MMF") and low-dose corticosteroids for the treatment of lupus nephritis ("LN").

    Aurinia previously announced positive efficacy and safety results from the AURORA Phase 3 pivotal trial in December 2019. These data will be submitted as part of the rolling submission for the voclosporin new drug application ("NDA"), which the Company expects to complete by the end of the second quarter of 2020.

    Full Presentation Details

    Title: Aurora Phase 3 Trial Demonstrates Voclosporin Statistical Superiority Over Standard of Care in Lupus Nephritis (LN)

    Session: Late-Breaking Abstract Presentations

    Presenter: Keisha Gibson, M.D., Ph.D., University of North Carolina School of Medicine, Chapel Hill, NC

    Date: Thursday, March 26, 2020; 4:15 p.m. – 4:45 p.m. CT

    Following the session, a reprint of the slide presentation will be accessible from Aurinia's website at: https://ir.auriniapharma.com/presentations.

    About AURORA

    The AURORA Phase 3 clinical trial is a global, double-blind, placebo-controlled study to evaluate whether voclosporin when added to background therapy of mycophenolate mofetil (MMF)/CellCept® can increase speed of and overall renal response rates in the presence of low dose steroids. The primary endpoint for the study is complete renal response at 52 weeks, after which patients can choose to enroll into a 104-week blinded extension study. Renal response was defined as UCPR of ≤ 0.5 mg/mg, eGFR ≥ 60 mL/min/1.73 m2, or no confirmed decrease from baseline in eGFR of > 20%, presence of sustained, low dose steroids and no administration of rescue medication. The target enrollment of 324 patients was surpassed with a total of 357 lupus nephritis (LN) patients randomized globally across sites in 27 countries.

    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. It has been shown to have 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 laws in other countries and until April 2028 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 Lupus Nephritis

    Lupus nephritis ("LN") is an inflammation of the kidney caused by Systemic Lupus Erythematosus ("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 (measuring proteinuria) where an early response correlates with 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 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, focal segmental glomerulosclerosis 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.

    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: positive efficacy and safety results from the AURORA Phase 3 pivotal trial, completing NDA priority review submissions in a successful and timely manner including a rolling submission and the anticipated NDA filing during the first half of 2020; the potential for commercial launch of voclosporin for use in LN in 2021; timeline challenges due to the COVID-19 outbreak, 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 and until April 2028 with anticipated pediatric extension; 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; that the results of the AURORA clinical study are pivotal and a potential game changer for LN patients; that voclosporin may be positioned to become the standard of care for people living with LN; that Aurinia will present AURORA study results at a future scientific conference during 2020. 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, DES and FSGS programs; that another company will not create a substantial competitive product for Aurinia's LN, DES and FSGS 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 FSGS 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 FSGS 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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  43. 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 has established its U.S. commercial center of operations in Rockville, Maryland. The new site will support Aurinia's plans for growth as it prepares for the potential approval and launch of voclosporin for the treatment of lupus nephritis in 2021.

    "We are thrilled to announce the opening of our U.S. commercial offices in Montgomery County, Maryland, as we continue to advance the development of voclosporin, which has the potential to become the first-ever approved treatment for patients suffering from lupus nephritis. This…

    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 has established its U.S. commercial center of operations in Rockville, Maryland. The new site will support Aurinia's plans for growth as it prepares for the potential approval and launch of voclosporin for the treatment of lupus nephritis in 2021.

    "We are thrilled to announce the opening of our U.S. commercial offices in Montgomery County, Maryland, as we continue to advance the development of voclosporin, which has the potential to become the first-ever approved treatment for patients suffering from lupus nephritis. This important milestone follows the recent build-out of our commercial leadership team, as we move swiftly, yet responsibly, toward commercial readiness," said Peter Greenleaf, President and Chief Executive Officer of Aurinia. "Maryland's commitment to attracting and supporting leading innovators played a key role in our decision to establish Aurinia's U.S. presence here. We look forward to joining and contributing to the ecosystem of top-notch biopharmaceutical companies and research institutions in Montgomery County, while we work to build a global company."

    Aurinia's Rockville site at 77 Upper Rock Circle will initially occupy 30,000 square feet, with potential expansions to 120,000 square feet. The company plans to hire up to 100 employees in the first year and up to 500 employees as the company expands its operations. It is located within the I-270 life sciences and biotech corridor, which is widely recognized as a hotbed of leading innovation and industry talent.

    The Maryland Department of Commerce has approved a $2 million conditional loan through Advantage Maryland, formerly the Maryland Economic Development Assistance Authority and Fund (MEDAAF), which will be distributed in $1 million increments as each phase of the project is complete. Additionally, Montgomery County has approved a conditional grant of $350,000 per phase of the project, with the City of Rockville contributing $25,000 for each phase. The company is also eligible for Maryland's Job Creation Tax Credit.

    Aurinia also announced on February 25, 2020, the appointment of Max Colao, to the newly created role of Chief Commercial Officer, along with the addition of a team of experts across key commercial functions in preparation for the potential commercial launch of voclosporin in early 2021.

    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 diseases with a high unmet medical need. The Company is currently developing an investigational drug for the treatment of lupus nephritis, focal segmental glomerulosclerosis 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.

    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: completing NDA priority review submissions in a successful and timely manner including the anticipated NDA filing during the second quarter of 2020; the potential for commercial launch of voclosporin for use in LN in the first half of 2021; voclosporin having the potential to become the first-ever approved treatment for patients suffering from lupus nephritis; voclosporin being potentially a best-in-class CNI with robust intellectual property exclusivity; ; that Aurinia has hired seasoned, distinguished world- class commercial leadership; that voclosporin may be positioned to become the standard of care for people living with 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, DES and FSGS programs; that another company will not create a substantial competitive product for Aurinia's LN, DES and FSGS 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 FSGS 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 FSGS 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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  44. - Company remains on track to complete submission by the end of the second quarter 2020 -

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (TSX:AUP) ("Aurinia" or the "Company"), a late-stage clinical biopharmaceutical company focused on advancing voclosporin in multiple indications, announced today that the Company has initiated a Rolling Submission of its New Drug Application ("NDA") to the U.S. Food and Drug Administration ("FDA") for voclosporin, a next-generation calcineurin inhibitor for the treatment of lupus nephritis ("LN"). The rolling NDA allows completed portions of an NDA to be submitted and reviewed by the Agency on an ongoing basis. Aurinia has submitted the Nonclinical Module and expects to complete the submission of all Modules…

    - Company remains on track to complete submission by the end of the second quarter 2020 -

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (TSX:AUP) ("Aurinia" or the "Company"), a late-stage clinical biopharmaceutical company focused on advancing voclosporin in multiple indications, announced today that the Company has initiated a Rolling Submission of its New Drug Application ("NDA") to the U.S. Food and Drug Administration ("FDA") for voclosporin, a next-generation calcineurin inhibitor for the treatment of lupus nephritis ("LN"). The rolling NDA allows completed portions of an NDA to be submitted and reviewed by the Agency on an ongoing basis. Aurinia has submitted the Nonclinical Module and expects to complete the submission of all Modules by the end of the second quarter of 2020.

    "Following a positive pre-NDA meeting with the FDA in February, we are pleased to initiate our rolling NDA submission to the Agency, a critical step toward making voclosporin available to patients as soon as possible. We look forward to working with the FDA throughout the process," commented Larry Mandt, Senior Vice President, Quality and Regulatory Affairs at Aurinia.

    Voclosporin was granted Fast Track designation by the FDA in 2016, with a Priority Review to be requested as part of the complete NDA submission anticipated by the end of Q2 2020.

    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 diseases with a high unmet medical need. The Company is currently developing an investigational drug for the treatment of LN, focal segmental glomerulosclerosis ("FSGS") and dry eye syndrome ("DES"). 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.

    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: completing the submission of all modules to the FDA by the end of the second quarter of 2020; receiving a positive review of the NDA; and receiving approval during early 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: Aurinia being 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 global conditions may cause delays in regulation approvals, including those caused by or related to the novel coronavirus. 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 (including any delays caused or related to the novel coronavirus). 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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  45. - Company recognizes World Kidney Day and National Kidney Month -

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) ("Aurinia" or the "Company") , a late-stage clinical biopharmaceutical company focused on advancing voclosporin across multiple inflammatory and autoimmune conditions, today announced new initiatives to support the lupus nephritis (LN) community and raise disease awareness on World Kidney Day, during National Kidney Month and beyond. These initiatives and resources include:

    • #ALLINorange: Through the ALL IN program, Aurinia is once again partnering with the National Kidney Foundation (NKF) on its #ALLINorange campaign throughout the month of March to raise awareness and understanding of LN. The ALL IN program is a source…

    - Company recognizes World Kidney Day and National Kidney Month -

    Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH, TSX:AUP) ("Aurinia" or the "Company") , a late-stage clinical biopharmaceutical company focused on advancing voclosporin across multiple inflammatory and autoimmune conditions, today announced new initiatives to support the lupus nephritis (LN) community and raise disease awareness on World Kidney Day, during National Kidney Month and beyond. These initiatives and resources include:

    • #ALLINorange: Through the ALL IN program, Aurinia is once again partnering with the National Kidney Foundation (NKF) on its #ALLINorange campaign throughout the month of March to raise awareness and understanding of LN. The ALL IN program is a source of information, resources, and support for those affected by LN and their care partners. ALL IN community members and those who newly register in March will receive #ALLINorange disease awareness bracelets to show support for National Kidney Month and the LN community. More information is available at www.allinforln.com.
    • ALL IN Lupus Nephritis Awareness Resource Kit: Aurinia also launched today a new resource kit for people living with LN and their care partners. The kit was created with input from members of the LN community to help expand awareness and knowledge of lupus nephritis. The resource kit is available at www.allinforln.com/awarenesskit.

    There is currently no FDA-approved therapy for LN, which is inflammation of the kidneys caused by systemic lupus erythematosus (SLE) and represents a serious progression of SLE. LN affects up to 50% of the SLE patient population.

    "Observances such as National Kidney Month and World Kidney Day are a reminder that people living with lupus nephritis are affected by the severe symptoms and complications associated with this disease each and every day. We are honored to work together with the community to advance understanding of this serious disease," said Neil Solomons, M.D. Chief Medical Officer at Aurinia. "The ALL IN program is a source of information, resources, and support for those affected by LN, and we are committed to continuing to build on materials and initiatives that benefit the community."

    More information about LN is available at www.allinforln.com. Members of the LN community can also find and share these resources and information about LN on Facebook @AuriniaPharma during National Kidney Month.

    About Lupus Nephritis

    Lupus nephritis (LN) is an inflammation of the kidney caused by Systemic Lupus Erythematosus (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 (measuring proteinuria) where an early response correlates with 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 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 diseases with a high unmet medical need. The Company is currently developing an investigational drug for the treatment of lupus nephritis, focal segmental glomerulosclerosis 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.

    About National Kidney Foundation

    The National Kidney Foundation (NKF) is the largest, most comprehensive, and longstanding patient-centric organization dedicated to the awareness, prevention, and treatment of kidney disease in the U.S. For more information about NKF, visit www.kidney.org.

    Forward-Looking Statement

    Certain of the statements made in this presentation may constitute forward-looking information within the meaning of applicable Canadian securities law and forward-looking statements within the meaning of applicable U.S. securities law. These forward-looking statements or information include but are not limited to statements or information with respect to lupus nephritis (LN), FSGS and Dry Eye Syndrome.

    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. 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 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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  46. - Cash and cash equivalents totaled approximately $306 million at December 31, 2019 -

    - Positive AURORA Phase 3 results with voclosporin enabling an NDA submission for the treatment of lupus nephritis ("LN") by the end of the second quarter 2020 -

    - Continued build out of a top-tier commercial team, highlighted by the appointment of Max Colao, Chief Commercial Officer, focused on launch activities -

    - AUDREY Phase2/3 Dry Eye Study remains on-track with results anticipated during the second half of 2020 -

    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, 2019. Amounts, unless specified otherwise, are expressed in U.S…

    - Cash and cash equivalents totaled approximately $306 million at December 31, 2019 -

    - Positive AURORA Phase 3 results with voclosporin enabling an NDA submission for the treatment of lupus nephritis ("LN") by the end of the second quarter 2020 -

    - Continued build out of a top-tier commercial team, highlighted by the appointment of Max Colao, Chief Commercial Officer, focused on launch activities -

    - AUDREY Phase2/3 Dry Eye Study remains on-track with results anticipated during the second half of 2020 -

    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, 2019. Amounts, unless specified otherwise, are expressed in U.S. dollars.

    "2019 was a truly transformational year for Aurinia, highlighted by the positive results achieved with voclosporin in the Phase 3 AURORA clinical trial for the treatment of LN. As the team works diligently to prepare and file a New Drug Application to the U.S. FDA next quarter, we continue to build out an incredibly talented and experienced commercial team that will be led by Max Colao, Aurinia's newly appointed Chief Commercial Officer," commented Peter Greenleaf, President and Chief Executive Officer of Aurinia.

    "Beyond the impact voclosporin could bring to those living with LN, we continue to evaluate voclosporin in additional indications, including the rare kidney disease, FSGS, as well as for the potential management of dry eye syndrome. During the second half of 2020, we anticipate reporting new data from both of these development programs, consisting of interim data from the exploratory Phase 2 FSGS study and results from the Phase 2/3 AUDREY DES trial evaluating 3 concentrations of VOS compared to vehicle alone," said Neil Solomons, Chief Medical Officer of Aurinia.

    Recent Operational Highlights

    Pre-NDA Meeting with the U.S. Food & Drug Administration ("FDA")

    Aurinia held a positive and successful Pre-NDA meeting with the FDA Division of Pulmonary, Allergy and Rheumatology Products on February 25, 2020. The Company presented information about the safety and efficacy data to be included in the filing, reviewed the format and content of the planned application, and gained agreement on the rolling review plans for filing modules of the NDA. No obstacles were raised by FDA that would prevent submission of the complete NDA by the end of the second quarter as planned.

    Appointment of Max Colao as Chief Commercial Officer and build out of commercial team

    On February 25, 2020, Aurinia announced the appointment of Max Colao to the newly created position of Chief Commercial Officer. In addition, Aurinia has recruited an experienced team of leaders across key commercial functions including sales, marketing, market access, and commercial operations.

    AURORA Phase 3 LN Trial

    On December 4, 2019, Aurinia announced positive efficacy and safety results from its pivotal AURORA Phase 3 trial of voclosporin, in combination with mycophenolate ("MMF") and low-dose corticosteroids, in the treatment of LN. The global study in which 357 patients with active LN were enrolled, met its primary endpoint of Renal Response rates of 40.8% for voclosporin vs. 22.5% for the control (OR 2.65; p < 0.001). Additionally, all pre-specified hierarchical secondary endpoints achieved statistical significance in favor of voclosporin, which included Renal Response at 24 weeks, Partial Renal Response at 24 and 52 weeks, time to achieve urinary protein-to-creatinine ratio ("UPCR") ≤ 0.5, and time to 50% reduction in UPCR. The robustness of the data was also supported by all pre-specified subgroup analyses (age, sex, race, biopsy class, region, and prior MMF use) favoring voclosporin.

    Voclosporin was well tolerated with no unexpected safety signals. Serious adverse events ("SAEs") were reported in 20.8% of voclosporin patients vs. 21.3% in the control arm. Infection was the most commonly reported SAE with 10.1% of voclosporin patients versus 11.2% of patients in the control arm. Overall mortality in the trial was low, with six deaths observed; one in the voclosporin arm and five in the control group. Additionally, the voclosporin arm showed no significant decrease at week 52 in estimated glomerular filtration rate ("eGFR") or increase in blood pressure, lipids or glucose, which are common adverse events associated with legacy calcineurin inhibitors ("CNIs").

    The AURORA Phase 3 clinical trial was initiated in May of 2017 and completed enrollment in September 2018.

    AURORA 2 Extension Trial

    Eligible patients completing the AURORA trial had the option to roll over into a 104-week blinded extension study (the "AURORA 2 extension study"). A total of 216 patients enrolled into the AURORA 2 extension study. The data from the AURORA 2 extension study will allow the Company to assess the long-term benefit/risk of voclosporin in LN patients, however, this study is not a requirement for potential regulatory approval for voclosporin. Data from the AURORA 2 extension study assessing long-term outcomes in LN patients should be valuable in a post-marketing setting and for future interactions with regulatory authorities.

    Voclosporin Drug-Drug Interaction ("DDI") Study

    On November 7, 2019, Aurinia announced the completion of a FDA-requested clinical DDI study in patients with lupus that investigated the potential effect of voclosporin on blood levels of mycophenolate acid ("MPA"), the active metabolite of MMF. MMF, also known as CellCept®, is considered by treating physicians to be part of the current standard of care for lupus nephritis ("LN") in the United States.

    This FDA-requested clinical DDI study aimed to measure, and potentially quantify, the impact voclosporin may have on MPA blood levels when given concomitantly with MMF in patients with lupus. The study results indicate that the coadministration of voclosporin with MMF had no clinically significant impact on MPA blood concentrations. In past studies, it was reported that the legacy calcineurin inhibitors ("CNIs") inhibit the multidrug-resistance-associated protein 2 (MRP-2) transporter in the biliary tract thereby preventing the excretion of mycophenolic acid glucuronide (MPAG) into the bile leading to the enterohepatic recirculation of MPA1. This adverse impact of cyclosporine on MPA pharmacokinetics has resulted in a 30 – 50% reduction in MPA exposure when used in combination.1

    Voclosporin ‘036 Method-of-Use Patent for Proteinuric Kidney Diseases

    On May 14, 2019, Aurinia was granted U.S. Patent 10,286,036 entitled ‘PROTOCOL FOR TREATMENT OF LUPUS NEPHRITIS") with a term potentially extending to December 2037, for claims directed at our novel voclosporin dosing protocol for LN. The allowed claims broadly cover the novel voclosporin individualized flat-dosed pharmacodynamic treatment protocol adhered to and required in both the previously reported Phase 2 AURA-LV study and our Phase 3 confirmatory AURORA trial. Notably, the allowed claims cover a method of modifying the dose of voclosporin in patients with LN based on patient specific pharmacodynamic parameters.

    If the FDA approves the use of voclosporin for LN and the label for such use follows the dosing protocol under the Notice of Allowance, the issuance of this patent will expand the scope of intellectual property protection for voclosporin until December 2037, supplementing an already robust manufacturing, formulation, synthesis and composition of matter patents.

    AUDREY™ Phase 2/3 Trial for Dry Eye Syndrome ("DES")

    In October 2019, Aurinia announced the initiation of patient dosing in the Phase 2/3 AUDREY™ clinical trial evaluating voclosporin ophthalmic solution ("VOS") for the potential treatment of DES. The AUDREY trial is a randomized, double-masked, vehicle-controlled, dose-ranging study evaluating the efficacy and safety of VOS in subjects with DES. A total of approximately 480 subjects are expected to be enrolled. The study will consist of four arms with a 1:1:1:1 randomization schedule, in which patients will receive 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 is the proportion of subjects with a 10mm improvement in Schirmer Tear Test ("STT") at four weeks. Secondary outcome measures will include 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. Top-line results from the AUDREY clinical study are anticipated during the second half of 2020.

    In January of 2019, Aurinia reported Phase 2 results demonstrating that VOS (voclosporin 0.2%) administered twice daily was superior to cyclosporin A 0.05% (Restasis®) administered twice daily across all objective endpoints including FCS and STT. This statistical superiority was observed after two weeks of dosing. The exploratory study also showed no statistically significant nor clinically meaningful difference in drop discomfort, as measured by drop discomfort scores at one and five minutes after first application, between VOS 0.2% and cyclosporin A 0.05%.

    Financial Liquidity at December 31, 2019

    At December 31, 2019, Aurinia had cash and cash equivalents of $306 million at December 31, 2019, compared to $125.9 million of cash and short-term investments at December 31, 2018. Net cash used in operating activities was $63.5 million for the year ended December 31, 2019, compared to $51.6 million for the year ended December 31, 2018.

    The Company received net proceeds of $179.9 million pursuant to its December 12, 2019, public offering.

    The Company believes that it has sufficient financial resources to fund its current plans, which include conducting its ongoing research and development ("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 2021.

    Financial Results for the Year Ended December 31, 2019

    For the year ended December 31, 2019, Aurinia recorded a consolidated net loss of $123.8 million or $1.33 per common share, which included a non-cash increase of $41.1 million related to the estimated fair value adjustment of derivative warrant liabilities during 2019 and at December 31, 2019.

    The net loss before the change in estimated fair value of derivative warrant liabilities and income taxes was $82.6 million or $0.89 per common share for the year ended December 31, 2019. This compared to a consolidated net loss of $64.1 million or $0.76 per common share in 2018, which included a non-cash increase of $10 million in the estimated fair value of derivative warrant liabilities for the year ended December 31, 2018. The net loss before the change in estimated fair value of derivative warrant liabilities income taxes was $54.1 million or $0.63 per common share for the year ended December 31, 2018.

    The change in the revaluation of the derivative warrant liabilities is primarily driven by the change in Aurinia's share price. The Company's share price was significantly higher in December 2019 when 1.83 million derivative warrants were exercised and at December 31, 2019, when the closing share price was $20.26, compared to the Company's share price of $6.82 at December 31, 2018. This increase in share price resulted in a large increase in the estimated fair value of the derivative warrants for 2019. The derivative warrant liabilities will ultimately be eliminated on the exercise of the warrants and will not result in any cash outlay by Aurinia. In fiscal year 2019, 3.6 million derivative warrants were exercised with 1.7 million derivative warrants outstanding as of December 31, 2019.

    Aurinia incurred R&D expenses of $52.9 million for the year ended December 31, 2019, as compared to $41.4 million for the year ended December 31, 2018. The increase in R&D expenses in 2019 included $6.6 million to manufacture voclosporin for potential future commercial use and higher costs related to the AURORA 2 extension trial, the DDI study and ongoing dry eye studies, partially offset by a decrease in AURORA trial costs.

    Aurinia incurred corporate, administration and business development expenses of $22.2 million for the year ended December 31, 2019, as compared with $13.7 million for the same period in fiscal 2018. The increase in these expenses reflected higher corporate activity levels including pre-commercial and launch readiness activities, higher professional and recruiting fees, insurance costs and personnel compensation costs.

    Non-cash stock compensation expense was $7.4 million for the year ended December 31, 2019, compared to $6.9 million for the year ended December 31, 2018, and was included in both R&D and corporate, general and business development expenses.

    Financial Results for the Fourth Quarter Ended December 31, 2019

    Aurinia reported a consolidated net loss of $76.5 million or $0.78 per common share for the fourth quarter ended December 31, 2019, as compared to a consolidated net loss of $14.6 million, or $0.17 per common share, for the fourth quarter ended December 31, 2018.

    The increase in the loss for the fourth quarter ended December 31, 2019, primarily reflected an increase of $48.0 million in the estimated fair value of derivative warrant liabilities compared to an increase of $593,000 in the estimated fair value of derivative warrant liabilities for the fourth quarter ended December 31, 2018.This change in the estimated fair value reflected the significant increase in the Company's share price in December 2019 when 1.83 million derivative warrants were exercised and at December 31, 2019, when the closing share price was $20.26, compared to the Company's share price of $6.82 at December 31, 2018.

    The net loss before the non-cash change in estimated fair value of derivative warrant liabilities and income taxes was $28.9 million or $0.29 per common share for the fourth quarter ended December 31, 2019, compared to $13.9 million or $0.17 per common share for the same period in 2018.

    R&D expenses increased to $13.3 million in the fourth quarter of 2019, compared to $10.8 million in the fourth quarter of 2018. The increase in these expenses reflected costs related to NDA submission preparation costs, higher personnel costs, higher costs incurred for the AURORA 2 extension trial, and the AUDREY DES phase 2/3 study partially offset by lower AURORA trial costs.

    Corporate, administration and business development expenses increased to $7.2 million for the fourth quarter of 2019, compared to $3.5 million for the fourth quarter of 2018, reflecting higher pre-commercial and launch readiness activities, higher consulting and professional fees, insurance costs, and personnel compensation costs as the corporate organization build continued to ramp up during the fourth quarter of 2019.

    The audited financial statements and the Management's Discussion and Analysis for the year ended December 31, 2019, 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 fourth quarter and year ended December 31, 2019, financial results today, Thursday, March 5, 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 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. It has been shown to have 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 laws in other countries and until April 2028 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 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, focal segmental glomerulosclerosis and dry eye syndrome. The Company's head office is in Victoria, British Columbia 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: completing NDA priority review submissions in a successful and timely manner including the anticipated NDA filing during the first half of 2020; the potential for commercial launch of voclosporin for use in LN in 2021; 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 and until April 2028 with anticipated pediatric extension; 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; that the results of the AURORA clinical study are pivotal and potentially groundbreaking for LN patients; that voclosporin may be positioned to become the standard of care for people living with LN; that Aurinia will present AURORA study results at a future scientific conference during 2020. 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, DES and FSGS programs; that another company will not create a substantial competitive product for Aurinia's LN, DES and FSGS 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 FSGS 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 FSGS 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.

    Aurinia Pharmaceuticals Inc.

    Condensed Consolidated Statements of Financial Position

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

     

    December 31,

    2019

    $

     

    December 31,

    2018

    $

    Assets

     

     

     

    Cash and cash equivalents

    306,019

     

    117,967

    Short term investments

    -

     

    7,889

    Accounts receivable and accrued interest receivable

    368

     

    217

    Prepaid expenses, deposits and other

    8,750

     

    6,775

    Total current assets

    315,137

     

    132,848

     

     

     

     

    Acquired intellectual property and other intangible assets

    11,244

     

    12,616

    Other non-current assets

    302

     

    399

    Total assets

    326,683

     

    145,863

     

     

     

     

    Liabilities and Shareholders' Equity

     

     

     

    Accounts payable and accrued liabilities

    11,177

     

    7,071

    Other current liabilities

    118

     

    190

    Total current liabilities

    11,295

     

    7,261

     

     

     

     

    Derivative warrant liabilities

    29,353

     

    21,747

    Other non-current liabilities

    12,519

     

    4,280

    Total liabilities

    53,167

     

    33,288

     

     

     

     

    Shareholders' equity

    273,516

     

    112,575

    Total liabilities and shareholders' equity

    326,683

     

    145,863

    Aurinia Pharmaceuticals Inc.

    Condensed Consolidated Statements of Operations

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

     

     

     

    Three Months Ended

    December 31

     

    Year Ended

    December 31

     

    2019

     

    2018

     

    2019

     

    2018

     

    $

     

    $

     

    $

     

    $

    Revenue

     

     

     

     

     

     

     

    Licensing revenue

    29

     

    29

     

    318

     

    118

    Contract revenue

    -

     

    -

     

    -

     

    345

     

     

     

     

     

     

     

     

     

    29

     

    29

     

    318

     

    463

     

     

     

     

     

     

     

     

    Expenses

     

     

     

     

     

     

     

    Research and development

    13,292

     

    10,839

     

    52,866

     

    41,382

    Corporate, administration and business development

    7,246

     

    3,498

     

    22,154

     

    13,674

    Amortization of acquired intellectual property and other intangible assets

    349

     

    349

     

    1,389

     

    1,545

    Amortization of property and equipment

    42

     

    6

     

    159

     

    20

    Other expenses

    7,963

     

    (65)

     

    8,991

     

    169