8-K
Aurinia Pharmaceuticals Inc. (AUPH)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 4, 2025
Aurinia Pharmaceuticals Inc.
(Exact name of registrant as specified in its charter)
| Canada | 001-36421 | 98-1231763 |
|---|---|---|
| (State or Other Jurisdiction of Incorporation) | (Commission File No.) | (IRS Employer Identification No.) |
#140, 14315 - 118 Avenue
Edmonton, Alberta
T5L 4S6
(250) 744-2487
(Address and telephone number of registrant's principal executive offices)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| --- | --- |
| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| --- | --- |
| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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Securities registered pursuant to Section 12(b) of the Act:
| Title of Each Class | Trading Symbol(s) | Name of Each Exchange on which Registered |
|---|---|---|
| Common Shares, without par value | AUPH | The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
| Item 2.02 | Results of Operations and Financial Condition |
|---|
On November 4, 2025, Aurinia Pharmaceuticals Inc. (Aurinia or the Company) issued a press release announcing its financial results for the quarter ended September 30, 2025. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated by reference herein.
The information in this Current Report on Form 8-K and the exhibit hereto are being furnished pursuant to this Item 2.02 and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. In addition, the information included in this Current Report on Form 8-K and the exhibit hereto that is furnished pursuant to this Item 2.02 shall not be incorporated by reference in any of Aurinia's filings under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, regardless of any general incorporation language in such filing, except as expressly set forth by specific reference in such filing.
| Item 9.01 | Financial Statements and Exhibits |
|---|
(d) Exhibits.
| Exhibit No. | Description |
|---|---|
| 99.1 | Earnings release dated November 4, 2025 |
| 99.2 | Aurinia's Third Quarter 2025 Update dated November 4, 2025 |
| 104 | Cover Page Interactive Data File (the cover page XBRL tags are embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: November 4, 2025
| AURINIA PHARMACEUTICALS INC. | |
|---|---|
| By: | /s/ Joseph Miller |
| Name: | Joseph Miller |
| Title: | Chief Financial Officer |
Document
| Exhibit 99.1 |
|---|
Aurinia Pharmaceuticals Reports Financial Results for the Three and Nine Months Ended September 30, 2025 and Provides Update on Recent Business Progress
Third Quarter 2025 LUPKYNIS Sales Grew 27%
LUPKYNIS Sales Guidance for 2025 Raised to $265 Million to $270 Million
Aritinercept Advances Toward Clinical Studies in Two Autoimmune Diseases
ROCKVILLE, Maryland and EDMONTON, Alberta – November 4, 2025 – Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) today announced financial results for the three and nine months ended September 30, 2025, and provided an update on recent business progress.
Financial Results
•Total Revenue: For the three and nine months ended September 30, 2025, total revenue was $73.5 million and $205.9 million, up 8% and 17%, respectively, from $67.8 million and $175.3 million, respectively, for the same periods of 2024.
–Net Product Sales: For the three and nine months ended September 30, 2025, net product sales of LUPKYNIS, the first FDA-approved oral therapy for the treatment of adult patients with active lupus nephritis, were $70.6 million and $197.2 million, up 27% and 24%, respectively, from $55.5 million and $158.6 million, respectively, for the same periods of 2024.
–License, Collaboration and Royalty Revenue: For the three and nine months ended September 30, 2025, license, collaboration and royalty revenue, which includes manufacturing services revenue from Aurinia’s collaboration partner, Otsuka, was $2.8 million and $8.8 million, respectively, compared to $12.3 million and $16.7 million, respectively, in the same periods of 2024. The 2024 periods included a milestone payment of $10.0 million associated with LUPKYNIS regulatory approval in Japan.
•Net Income: For the three and nine months ended September 30, 2025, net income was $31.6 million and $76.4 million, up 119% and 1677%, respectively, compared to $14.4 million and $4.3 million, respectively, for the same periods of 2024.
•Diluted Earnings per Share: For the three and nine months ended September 30, 2025, diluted earnings per share was $0.23 and $0.55, up 130% and 1733%, respectively, compared to $0.10 and $0.03, respectively, for the same periods of 2024.
•Cash Flows from Operating Activities: For the three and nine months ended September 30, 2025, cash flows from operating activities were $44.5 million and $90.0 million, up 162% and 529%, respectively, compared to $17.0 million and $14.3 million, respectively, for the same periods of 2024.
Cash Position
As of September 30, 2025, Aurinia had cash, cash equivalents, restricted cash and investments of $351.8 million, compared to $358.5 million at December 31, 2024. For the nine months ended September 30, 2025, the Company repurchased 12.2 million of its common shares for $98.2 million.
Full Year 2025 Total Revenue and Net Product Sales Guidance
For 2025, Aurinia is increasing total revenue guidance from a range of $260 million to $270 million to a range of $275 million to $280 million and net product sales guidance from a range of $250 million to $260 million to a range of $265 million to $270 million.
“LUPKYNIS sales experienced continued momentum following last year’s update to the American College of Rheumatology lupus nephritis treatment guidelines, which recommend the incorporation of drugs like LUPKYNIS into first-line therapy in order to preserve kidney function,” stated Peter Greenleaf, President and Chief Executive Officer of Aurinia. “Additionally, we are excited about the positive results from our Phase 1 study of aritinercept, a dual inhibitor of B cell-activating factor (BAFF) and a proliferation-inducing ligand (APRIL) and look forward to initiating clinical studies in two autoimmune diseases by the end of this year.”
Webcast & Conference Call Details
A webcast and conference call will be hosted today, November 4, at 8:30 a.m. ET. The link to the audio webcast is available here. To join the conference call, please dial 877-407-9170/+1 201-493-6756. A replay of the webcast will be available on Aurinia’s website.
About Aurinia
Aurinia is a biopharmaceutical company focused on delivering therapies to people living with autoimmune diseases with high unmet medical needs. In January 2021, the Company introduced LUPKYNIS® (voclosporin), the first FDA-approved oral therapy for the treatment of adult patients with active lupus nephritis. Aurinia is also developing aritinercept, a dual inhibitor of B cell-activating factor (BAFF) and a proliferation-inducing ligand (APRIL) for the potential treatment of autoimmune diseases.
Forward-Looking Statements
This press release contains forward-looking information within the meaning of applicable Canadian securities law and forward-looking statements within the meaning of applicable U.S. securities law. We caution investors that forward-looking statements are based on management’s expectations and assumptions as of the date of this press release and involve substantial risks and uncertainties that could cause the actual outcomes to differ materially from what we currently expect. These risks and uncertainties include, but are not limited to, those associated with: LUPKYNIS net product sales, the timing of clinical study results and other risks and uncertainties identified in our filings with the U.S. Securities and Exchange Commission. Forward-looking statements in this press release apply only as of the date made, and we undertake no obligation to update or revise any forward-looking statements to reflect subsequent events or circumstances. 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 and its other public available filings available by accessing the Canadian Securities Administrators’ System for Electronic Document Analysis and Retrieval (SEDAR) website at www.sedarplus.ca or the U.S. Securities and Exchange Commission’s Electronic Document Gathering and Retrieval System (EDGAR) website at www.sec.gov/edgar, and on Aurinia’s website at www.auriniapharma.com.
General Investor Inquiries
ir@auriniapharma.com
AURINIA PHARMACEUTICALS INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
| September 30, 2025 | December 31, 2024 | |||
|---|---|---|---|---|
| (Unaudited) | ||||
| ASSETS | ||||
| Current assets: | ||||
| Cash, cash equivalents and restricted cash | $ | 73,189 | $ | 83,433 |
| Short-term investments | 278,619 | 275,043 | ||
| Accounts receivable, net | 30,728 | 36,544 | ||
| Inventory, net | 44,793 | 39,228 | ||
| Prepaid expenses and deposits | 11,107 | 11,219 | ||
| Other current assets | 301 | 1,129 | ||
| Total current assets | 438,737 | 446,596 | ||
| Finance right-of-use lease assets | 78,813 | 92,072 | ||
| Intangible assets, net | 3,901 | 4,355 | ||
| Operating right-of-use lease assets | 3,718 | 4,068 | ||
| Property and equipment, net | 2,266 | 2,731 | ||
| Other noncurrent assets | 93 | 823 | ||
| Total assets | $ | 527,528 | $ | 550,645 |
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||
| Current liabilities: | ||||
| Accounts payable | $ | 2,214 | $ | 5,187 |
| Accrued expenses | 49,536 | 64,971 | ||
| Finance lease liabilities, current portion | 16,309 | 14,046 | ||
| Deferred revenue | 4,602 | 11,002 | ||
| Operating lease liabilities, current portion | 1,057 | 1,026 | ||
| Other current liabilities | 2,502 | 1,531 | ||
| Total current liabilities | 76,220 | 97,763 | ||
| Finance lease liabilities, less current portion | 55,727 | 58,554 | ||
| Deferred revenue, less current portion | 12,249 | 1,699 | ||
| Deferred compensation and other noncurrent liabilities | 12,442 | 9,408 | ||
| Operating lease liabilities, less current portion | 5,119 | 5,743 | ||
| Total liabilities | 161,757 | 173,167 | ||
| Shareholders' equity | ||||
| Common shares - no par value, unlimited shares authorized, 131,841 and 140,883 shares issued and outstanding at September 30, 2025 and December 31, 2024, respectively | 1,116,797 | 1,187,696 | ||
| Additional paid-in capital | 109,885 | 126,999 | ||
| Accumulated other comprehensive loss | (749) | (647) | ||
| Accumulated deficit | (860,162) | (936,570) | ||
| Total shareholders' equity | 365,771 | 377,478 | ||
| Total liabilities and shareholders' equity | $ | 527,528 | $ | 550,645 |
AURINIA PHARMACEUTICALS INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(in thousands, except per share data)
| Three Months Ended | Nine Months Ended | |||||||
|---|---|---|---|---|---|---|---|---|
| September 30, | September 30, | |||||||
| 2025 | 2024 | 2025 | 2024 | |||||
| Revenue | ||||||||
| Net product sales | $ | 70,627 | $ | 55,503 | $ | 197,172 | $ | 158,604 |
| License, collaboration and royalty revenue | 2,841 | 12,268 | 8,769 | 16,662 | ||||
| Total revenue | 73,468 | 67,771 | 205,941 | 175,266 | ||||
| Operating expenses | ||||||||
| Cost of revenue | 8,177 | 6,035 | 23,866 | 22,696 | ||||
| Selling, general and administrative | 26,182 | 42,367 | 72,539 | 134,996 | ||||
| Research and development | 8,435 | 3,047 | 21,610 | 12,678 | ||||
| Restructuring | — | — | 1,647 | 7,755 | ||||
| Other expense, net | 929 | 4,574 | 14,604 | 159 | ||||
| Total operating expenses | 43,723 | 56,023 | 134,266 | 178,284 | ||||
| Income (loss) from operations | 29,745 | 11,748 | 71,675 | (3,018) | ||||
| Interest income | 3,316 | 4,267 | 10,075 | 12,982 | ||||
| Interest expense | (1,099) | (1,208) | (3,283) | (3,689) | ||||
| Net income before income taxes | 31,962 | 14,807 | 78,467 | 6,275 | ||||
| Income tax expense | 411 | 457 | 2,059 | 1,952 | ||||
| Net income | $ | 31,551 | $ | 14,350 | $ | 76,408 | $ | 4,323 |
| Earnings per share | ||||||||
| Basic | $ | 0.24 | $ | 0.10 | $ | 0.57 | $ | 0.03 |
| Diluted | $ | 0.23 | $ | 0.10 | $ | 0.55 | $ | 0.03 |
| Shares used in computing earnings per share | ||||||||
| Basic | 131,808 | 143,051 | 135,163 | 143,353 | ||||
| Diluted | 136,008 | 145,651 | 138,959 | 145,010 |
AURINIA PHARMACEUTICALS INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(in thousands)
| Nine Months Ended<br><br>September 30, | ||||
|---|---|---|---|---|
| 2025 | 2024 | |||
| Cash flows from operating activities: | ||||
| Net income | $ | 76,408 | $ | 4,323 |
| Adjustments to reconcile net income to cash flows from operating activities: | ||||
| Share-based compensation | 7,950 | 22,650 | ||
| Amortization and depreciation | 14,585 | 14,583 | ||
| Foreign exchange loss (gain) on revaluation of Monoplant finance lease liability | 9,318 | (718) | ||
| Net amortization of premiums and discounts on investments | (7,844) | (9,752) | ||
| Other, net | 4,852 | 220 | ||
| Net changes in operating assets and liabilities: | ||||
| Accounts receivable, net | 5,816 | (12,394) | ||
| Inventory, net | (5,565) | 991 | ||
| Prepaid expenses and other current assets | 940 | (6,001) | ||
| Other noncurrent operating assets | 730 | (12) | ||
| Accounts payable | (2,973) | 4,551 | ||
| Accrued expenses and other liabilities | (17,777) | (4,139) | ||
| Deferred revenue | 4,150 | 522 | ||
| Lease liabilities | (600) | (550) | ||
| Cash flows from operating activities | 89,990 | 14,274 | ||
| Cash flows from investing activities: | ||||
| Proceeds from the sale and maturities of investments | 348,785 | 461,448 | ||
| Purchases of investments | (344,618) | (461,140) | ||
| Purchases of property, equipment and intangible assets | (180) | (225) | ||
| Upfront lease payment | — | (44) | ||
| Cash flows from investing activities | 3,987 | 39 | ||
| Cash flows from financing activities: | ||||
| Repurchase of common shares | (98,156) | (18,435) | ||
| Principal portion of finance lease payments | (9,649) | (8,959) | ||
| Proceeds from issuance of common shares from exercise of stock options and vesting of RSUs and performance awards | 12,583 | 6,537 | ||
| Proceeds from issuance of common shares under ESPP | 401 | 703 | ||
| Taxes paid related to net settlement of exercises of stock options and vesting of RSUs and performance awards | (9,400) | (5,892) | ||
| Cash flows from financing activities | (104,221) | (26,046) | ||
| Net decrease in cash, cash equivalents and restricted cash | (10,244) | (11,733) | ||
| Cash, cash equivalents and restricted cash, beginning of the period | 83,433 | 48,875 | ||
| Cash, cash equivalents and restricted cash, end of the period | $ | 73,189 | $ | 37,142 |
5
thirdquarter2025updatede
® Third Quarter 2025 Update November 4, 2025
® Forward-Looking Statements This presentation contains forward-looking statements within the meaning of applicable U.S. securities law and forward-looking information within the meaning of applicable Canadian securities law. We caution investors that forward-looking statements are based on management’s expectations and assumptions as of the date of this presentation and involve substantial risks and uncertainties that could cause the actual outcomes to differ materially from what we currently expect. These risks and uncertainties include, but are not limited to, those associated with: total revenue; net product sales; the timing, design and results of clinical studies; and other risks and uncertainties identified in our filings with the U.S. Securities and Exchange Commission. Forward-looking statements in this presentation apply only as of the date made, and we undertake no obligation to update or revise any forward-looking statements to reflect subsequent events or circumstances. 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 and its other public available filings available by accessing the Canadian Securities Administrators’ System for Electronic Document Analysis and Retrieval (SEDAR) website at www.sedarplus.ca or the U.S. Securities and Exchange Commission’s Electronic Document Gathering and Retrieval System (EDGAR) website at www.sec.gov/edgar, and on Aurinia’s website at www.auriniapharma.com. 2
® Third Quarter 2025 Financial Highlights and Recent Business Progress 3 • Third quarter 2025 LUPKYNIS sales experienced continued momentum following last year’s inclusion in American College of Rheumatology Guidelines, growing 27% • LUPKYNIS sales guidance for 2025 raised for second time this year, to $265 million to $270 million • New LUPKYNIS data analyses reinforce LUPKYNIS’ robust clinical benefit in the treatment of patients with lupus nephritis • Following positive Phase 1 results, aritinercept advances toward clinical studies in two autoimmune diseases
® Third Quarter 2025 Financial Update
® Results for the Three Months Ended September 30 5 Three Months Ended September 30 % Change 2025 2024 Total Revenue $73.5 million $67.8 million a 8% Net Product Sales $70.6 million $55.5 million 27% Net Income $31.6 million $14.4 million 119% Diluted Earnings per Share $0.23 $0.10 130% Cash Flows from Operating Activities $44.5 million $17.0 million 162% a The 2024 period included a milestone payment of $10.0 million associated with LUPKYNIS regulatory approval in Japan
® Results for the Nine Months Ended September 30 6 Nine Months Ended September 30 % Change 2025 2024 Total Revenue $205.9 million $175.3 million a 17% Net Product Sales $197.2 million $158.6 million 24% Net Income $76.4 million $4.3 million 1677% Diluted Earnings per Share $0.55 $0.03 1733% Cash Flows from Operating Activities $90.0 million $14.3 million 529% a The 2024 period included a milestone payment of $10.0 million associated with LUPKYNIS regulatory approval in Japan
® Cash Flows and Financial Position 7 Three Months Ended September 30, 2025 Nine Months Ended September 30, 2025 Beginning Cash, Cash Equivalents, Restricted Cash and Investments $315.1 million $358.5 million Cash Flows from Operating Activities $44.5 million $90.0 million Repurchase of Shares $(8.7) million $(98.2) million Other $0.9 million $1.5 million Ending Cash, Cash Equivalents, Restricted Cash and Investments $351.8 million $351.8 million Diluted Shares Outstanding Beginning of Period 138.3 million 149.8 million Diluted Shares Outstanding End of Period 138.2 million 138.2 million
® Net Product Sales 2021 2022 2023 2024 2025 Guidance Range a $45.5M $103.5M $158.5M $216.2M $270.0M $265.0M 2025 Financial Guidance Increase 8 Initial Guidance Most Recent Guidance Current Guidance a Total Revenue $250 million to $260 million $260 million to $270 million $275 million to $280 million Net Product Sales $240 million to $250 million $250 million to $260 million $265 million to $270 million a Guidance as of November 4, 2025
® LUPKYNIS Update
® New Analyses Support LUPKYNIS’ Robust Clinical Benefit in the Treatment of Patients with Lupus Nephritis • Aurinia is sharing some new analyses of the results of the Phase 3 (AURORA 1 and AURORA 2) and Phase 2 (AURA-LV) studies that formed the basis of the 2021 FDA approval of LUPKYNIS and the 2024 FDA approval of the supplemental NDA for LUPKYNIS • These analyses were recently shared with the FDA in response to an information request • LUPKYNIS was granted full (not accelerated) FDA approval based on a statistically significant and clinically meaningful improvement in Complete Renal Response at Week 52 • The new analyses, which show that LUPKYNIS also was associated with a statistically significant and clinically meaningful reduction in the risk of Renal-Related Events or Death, reinforce the robust efficacy and favorable safety profile of LUPKYNIS 10
® 11 Time to Renal-Related Event or Death a (AURORA 1 Phase 3 Population) P ro b a b il it y o f E v e n t (% ) 50 45 40 35 30 25 20 15 10 5 0 0 13 26 39 52 65 Time from First Dose (Weeks) Treatment Events (%) HR (95% CI) P-value LUPKYNIS 26 (14.6) 0.466 (0.290, 0.747) 0.0012 Placebo 51 (28.7) - LUPKYNIS 0.0 [178] 3.4 [171] 10.2 [156] 13.7 [144] 14.9 [118] 14.9 [2] Placebo 0.0 [178] 7.9 [161] 20.0 [137] 25.3 [125] 28.9 [92] Probability [N at Risk]: LUPKYNIS Placebo Censored a Time to renal-related event or death is defined as the time to the first occurrence of death, treatment failure, worsening proteinuria or worsening eGFR
® Aritinercept Update
® Aritinercept Is a Dual BAFF/APRIL Inhibitor • Aritinercept contains a BCMA-engineered extracellular binding domain optimized for superior affinity to BAFF and APRIL (others use TACI-engineered extracellular binding domain) − BCMA has a stronger natural affinity for APRIL than TACI a • Aritinercept contains an IgG4 Fc domain with no appreciable effector function (others use IgG1 Fc domain) − IgG4 is considered the least inflammatory across the IgG subclasses, in part because it poorly activates the complement system b Engineered extracellular domain of BCMA receptor AUR200 BAFF APRIL Fc domain of IgG4 Aritinercept BAFF=B cell-activating factor; APRIL=a proliferation-inducing ligand; BCMA=B cell maturation antigen; TACI=transmembrane activator and CAML interactor; Fc=fragment crystallizable region; IgG4=immunoglobulin G4 a Mathur et al., J Clin Med 2023 b Oskam et al., Front Immun 2023 13
® Role of BAFF and APRIL • BAFF and APRIL are important cytokines that regulate B cell survival and differentiation, whose targets are expressed on B cells at different stages of B cell development a • Targeting both BAFF and APRIL depletes a broader set of B cells, including plasma cells, than targeting a single cytokine • Aritinercept may prevent the activation of autoreactive B cells and reduce their numbers and associated immunoglobulins (antibodies) in the body, thereby reducing important drivers of B cell-mediated autoimmune diseases B Cell Maturation b APRIL Dependency BAFF Dependency a Mathur et al., J Clin Med 2023 b Schrezenmeier et al., J Am Soc Nephrol 2018 14
® Placebo n=2 5 mg SC n=6 Screening Dose Level 1 (n=8 Healthy Subjects) Screening (up to 5 weeks), In-Clinic Phase (1 week) and Out-Patient Visits (13 weeks) 15 Placebo n=2 25 mg SC n=6 Screening Dose Level 2 (n=8 Healthy Subjects) Placebo n=2 75 mg SC n=6 Screening Dose Level 3 (n=8 Healthy Subjects) Placebo n=5 150 mg SC n=16 Screening Dose Level 4 (n=21 Healthy Subjects) Placebo n=2 225 mg SC n=6 Screening Dose Level 5 (n=8 Healthy Subjects) Placebo n=2 300 mg SC n=6 Screening Dose Level 6 (n=8 Healthy Subjects) SC=subcutaneous The SAD study included an expanded cohort at 150 mg Aritinercept Single Ascending Dose (SAD) Study: Design
® Aritinercept SAD Study: Safety Summary • Aritinercept was well tolerated at all dose levels tested • No treatment-related Grade ≥3 adverse events a • No treatment-related serious adverse events (SAEs) a • No discontinuations due to treatment-related adverse events • Adverse events that occurred in more than one subject included: – Injection site reactions b (24% aritinercept, 13% placebo) o All injection site reactions were Grade 1 – Headache (11% aritinercept, 7% placebo) – Upper respiratory tract infection (7% aritinercept, 0% placebo) – Back pain (4% aritinercept, 0% placebo) • Anti-drug antibodies (ADAs) were detected in the majority of subjects at dose levels of 25 mg and higher – The presence of ADAs was not associated with any changes in safety, pharmacokinetic or pharmacodynamic parameters a There was one Grade ≥3 adverse event and one SAE (same event) of concussion due to motor vehicle accident reported as not treatment related b Injection site reaction includes bruising, erythema, induration, pain, pruritus, swelling and tenderness 16
® 0 7 14 21 28 Study Day 20% 0% -20% -40% -60% 20% 0% -20% -40% -60% 0 7 14 21 28 M e a n C h a n g e f ro m B a s e li n e Study Day 20% 0% -20% -40% -60% 0 7 14 21 28 Study Day Aritinercept SAD Study: Single Doses of Aritinercept Led to Robust and Long-Lasting Reductions in Immunoglobulins in Humans 17 Pharmacodynamic effects are supportive of once-monthly dosing IgA IgM IgG Mean IgA reductions of up to 48% Mean IgM reductions of up to 55% Mean IgG reductions of up to 20%
® Summary and Next Steps • Aritinercept was well tolerated at all dose levels tested • Single doses of aritinercept led to robust and long-lasting reductions in immunoglobulins supportive of once-monthly dosing • Aurinia plans to initiate clinical studies of aritinercept in two autoimmune diseases by the end of 2025 18
® Q & A
® Appendix 1: Additional Analyses from LUPKYNIS Phase 3 and Phase 2 Clinical Studies
® 21 Time to Renal-Related Event or Death and Additional Renal-Related Events (AURORA 1 and AURORA 2 Phase 3 Populations) AURORA 1 Week 0-52 AURORA 1 and AURORA 2 Integrated Week 0-156 LUPKYNIS 23.7 mg BID N=178 n (%) PBO N=178 n (%) Hazard Ratio vs. PBO HR (95% CI) LUPKYNIS 23.7 mg BID N=178 n (%) PBO N=178 n (%) Hazard Ratio vs. PBO HR (95% CI) Time to Renal-Related Event or Death * Subjects with event 26 (14.6%) 51 (28.7%) 0.47 (0.29, 0.75) 46 (25.8%) 72 (40.4%) 0.56 (0.39, 0.81) Median time to event Not reached Not reached Not reached Not reached Adverse Event Death 1 (0.6%) 5 (2.8%) 0.19 (0.02, 1.65) 1 (0.6%) 9 (5.1%) 0.11 (0.01, 0.84) Treatment failure a 17 (9.6%) 35 (19.7%) 0.45 (0.25, 0.81) 33 (18.5%) 49 (27.5%) 0.61 (0.39, 0.95) Worsening proteinuria b 7 (3.9%) 25 (14.0%) 0.26 (0.11, 0.60) 11 (6.2%) 36 (20.2%) 0.27 (0.14, 0.53) Worsening eGFR c 22 (12.4%) 22 (12.4%) 0.96 (0.53, 1.73) 33 (18.5%) 28 (15.7%) 1.09 (0.66, 1.80) Additional Renal-Related Events End-stage renal disease (ESRD) 2 (1.1%) 1 (0.6%) 1.92 (0.17, 21.22) 2 (1.1%) 1 (0.6%) 1.92 (0.17, 21.18) Doubling of serum creatinine from baseline ** 11 (6.2%) 11 (6.2%) 0.97 (0.42, 2.24) 15 (8.4%) 17 (9.6%) 0.83 (0.42, 1.67) Renal worsening d 29 (16.3%) 35 (19.7%) 0.81 (0.49, 1.32) 41 (23.0%) 46 (25.8%) 0.83 (0.54, 1.26) Renal-related treatment failure e 12 (6.7%) 22 (12.4%) 0.52 (0.26, 1.04) 22 (12.4%) 33 (18.5%) 0.60 (0.35, 1.04) a Treatment failure is present if any of the following are met: 1) new ESRD or need for chronic dialysis or renal transplantation, clinically significant, 2) sustained worsening in UPCR and/or eGFR from Week 24 onward that leads the investigator to conclude the subject has failed the randomized treatment period, or 3) receipt of rescue therapy, except corticosteroid-only rescue. b Worsening proteinuria is defined as a confirmed ≥ 50% increase in UPCR from baseline to a value ≥3 after Week 12 onward. c Worsening eGFR is defined as a confirmed ≥30% decrease in eGFR from baseline to a value <60 after Week 12 onward. d Renal worsening may be defined as increased proteinuria and/or impaired renal function defined as: 1) increased proteinuria (using spot urine): a reproducible increase in 24-hour urine protein levels to >1 g/g if the baseline value was <0.2 g/g or >2 g/g if the baseline value was between 0.2 g/g and 1 g/g or more than twice the value at baseline if the baseline value was >1 g/g; and 2) impaired renal function: a reproducible decrease in eGFR of >20% accompanied by at least 1 of the following: proteinuria (>1 g/g), red blood cell casts, or white blood cell casts. e Renal-related treatment failure may be defined as intake of prohibited medications for inadequate lupus nephritis control or renal flare management. * Time to renal-related event or death is defined as the time to the first occurrence of death, treatment failure, worsening proteinuria or worsening eGFR. **Doubling of serum creatinine from baseline was determined by comparing serum creatinine levels at baseline to a confirmed value at least 2 times baseline after Week 12 onward.
® 22 Time to Renal-Related Event or Death and Additional Renal-Related Events (AURORA 1 Phase 3, AURA-LV Phase 2 and AURORA 2 Phase 3 Populations) AURORA 1 and AURA-LV Integrated Week 0-52 AURORA 1, AURA-LV and AURORA 2 Integrated Week 0-156 LUPKYNIS 23.7 mg BID N=267 n (%) PBO N=266 n (%) Hazard Ratio vs. PBO HR (95% CI) LUPKYNIS 23.7 mg BID N=267 n (%) PBO N=266 n (%) Hazard Ratio vs. PBO HR (95% CI) Time to Renal-Related Event or Death * Subjects with event 53 (19.9%) 75 (28.2%) 0.69 (0.48, 0.98) 73 (27.3%) 96 (36.1%) 0.71 (0.52, 0.96) Median time to event Not reached Not reached Not reached Not reached Adverse Event Death 11 (4.1%) 6 (2.3%) 1.83 (0.68, 4.94) 11 (4.1%) 10 (3.8%) 1.09 (0.46, 2.57) Treatment failure a 31 (11.6%) 50 (18.8%) 0.61 (0.39, 0.95) 47 (17.6%) 64 (24.1%) 0.69 (0.47, 1.01) Worsening proteinuria b 8 (3.0%) 34 (12.8%) 0.22 (0.10, 0.47) 12 (4.5%) 45 (16.9%) 0.24 (0.13, 0.45) Worsening eGFR c 32 (12.0%) 26 (9.8%) 1.22 (0.73, 2.05) 43 (16.1%) 32 (12.0%) 1.28 (0.81, 2.03) Additional Renal-Related Events End-stage renal disease (ESRD) 2 (0.7%) 2 (0.8%) 0.97 (0.14, 6.89) 2 (0.7%) 2 (0.8%) 0.97 (0.14, 6.88) Doubling of serum creatinine from baseline ** 11 (4.1%) 12 (4.5%) 0.89 (0.39, 2.02) 15 (5.6%) 18 (6.8%) 0.79 (0.40, 1.56) Renal worsening d 43 (16.1%) 48 (18.0%) 0.89 (0.59, 1.34) 55 (20.6%) 59 (22.2%) 0.89 (0.62, 1.29) Renal-related treatment failure e 18 (6.7%) 29 (10.9%) 0.60 (0.33, 1.08) 28 (10.5%) 40 (15.0%) 0.65 (0.40, 1.05) a Treatment failure is present if any of the following are met: 1) new ESRD or need for chronic dialysis or renal transplantation, clinically significant, 2) sustained worsening in UPCR and/or eGFR from Week 24 onward that leads the investigator to conclude the subject has failed the randomized treatment period, or 3) receipt of rescue therapy, except corticosteroid-only rescue. b Worsening proteinuria is defined as a confirmed ≥ 50% increase in UPCR from baseline to a value ≥3 after Week 12 onward. c Worsening eGFR is defined as a confirmed ≥30% decrease in eGFR from baseline to a value <60 after Week 12 onward. d Renal worsening may be defined as increased proteinuria and/or impaired renal function defined as: 1) increased proteinuria (using spot urine): a reproducible increase in 24-hour urine protein levels to >1 g/g if the baseline value was <0.2 g/g or >2 g/g if the baseline value was between 0.2 g/g and 1 g/g or more than twice the value at baseline if the baseline value was >1 g/g; and 2) impaired renal function: a reproducible decrease in eGFR of >20% accompanied by at least 1 of the following: proteinuria (>1 g/g), red blood cell casts, or white blood cell casts. e Renal-related treatment failure may be defined as intake of prohibited medications for inadequate lupus nephritis control or renal flare management. * Time to renal-related event or death is defined as the time to the first occurrence of death, treatment failure, worsening proteinuria or worsening eGFR. **Doubling of serum creatinine from baseline was determined by comparing serum creatinine levels at baseline to a confirmed value at least 2 times baseline after Week 12 onward.
® Appendix 2: Immunoglobulin Reductions from Aritinercept and Other BAFF/APRIL Inhibitors
® 20% 0% -20% -40% -60% Effect of a Single Dose of BAFF/APRIL Inhibitors on IgA 24 a The figure and table above represent cross-trial comparisons of SAD studies. No head-to-head clinical studies have been conducted. Adapted from Davies et al., Clin Trans Sci 2024 (povetacicept); Zhang et al., Clin Pharm Drug Dev 2023 (sibeprenlimab); Willen et al., Eur J Drug Metab Ph 2020 (atacicept); Xie et al., Clin Pharm Drug Dev 2022 (telitacicept). Dose levels for povetacicept, sibeprenlimab, atacicept and telitacicept represent dose levels selected by respective sponsors for Phase 3 development. Reductions in IgA a Drug (Sponsor) Mean % Change from Baseline in IgA at Day 28 a Aritinercept (Aurinia) -48% Povetacicept (Vertex) -43% Sibeprenlimab (Otsuka) -41% Atacicept (Vera) -10% Telitacicept (RemeGen/Vor Bio) 7% 0 7 14 21 28 Study Day Aritinercept (225 mg SC) Povetacicept (80 mg SC) Sibeprenlimab (400 mg SC) Atacicept (150 mg SC) Telitacicept (240 mg SC) M e a n C h a n g e f ro m B a s e li n e
® Effect of a Single Dose of BAFF/APRIL Inhibitors on IgM 25 Reductions in IgM a 0 7 14 21 28 Study Day Aritinercept (225 mg SC) Povetacicept (80 mg SC) Sibeprenlimab (400 mg SC) Atacicept (150 mg SC) Telitacicept (240 mg SC) 20% 0% -20% -40% -60% Drug (Sponsor) Mean % Change from Baseline in IgM at Day 28 a Aritinercept (Aurinia) -55% Povetacicept (Vertex) -52% Sibeprenlimab (Otsuka) -39% Atacicept (Vera) -17% Telitacicept (RemeGen/Vor Bio) 6% M e a n C h a n g e f ro m B a s e li n e a The figure and table above represent cross-trial comparisons of SAD studies. No head-to-head clinical studies have been conducted. Adapted from Davies et al., Clin Trans Sci 2024 (povetacicept); Zhang et al., Clin Pharm Drug Dev 2023 (sibeprenlimab); Willen et al., Eur J Drug Metab Ph 2020 (atacicept); Xie et al., Clin Pharm Drug Dev 2022 (telitacicept). Dose levels for povetacicept, sibeprenlimab, atacicept and telitacicept represent dose levels selected by respective sponsors for Phase 3 development.
® Effect of a Single Dose of BAFF/APRIL Inhibitors on IgG 26 b There was no apparent reduction in serum IgG levels following single-dose atacicept at any of the tested doses Reductions in IgG a 0 7 14 21 28 Study Day Aritinercept (225 mg SC) Povetacicept (80 mg SC) Sibeprenlimab (400 mg SC) Telitacicept (240 mg SC) 20% 0% -20% -40% -60% Drug (Sponsor) Mean % Change from Baseline in IgG at Day 28 a Aritinercept (Aurinia) -20% Povetacicept (Vertex) -19% Sibeprenlimab (Otsuka) -13% Atacicept (Vera) N/A b Telitacicept (RemeGen/Vor Bio) 7% M e a n C h a n g e f ro m B a s e li n e a The figure and table above represent cross-trial comparisons of SAD studies. No head-to-head clinical studies have been conducted. Adapted from Davies et al., Clin Trans Sci 2024 (povetacicept); Zhang et al., Clin Pharm Drug Dev 2023 (sibeprenlimab); Willen et al., Eur J Drug Metab Ph 2020 (atacicept); Xie et al., Clin Pharm Drug Dev 2022 (telitacicept). Dose levels for povetacicept, sibeprenlimab, atacicept and telitacicept represent dose levels selected by respective sponsors for Phase 3 development.
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