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): June 30, 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)) |
| --- | --- |
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 8.01 | Other Events |
|---|
On June 30, 2025, Aurinia Pharmaceuticals Inc. (Aurinia or the Company) issued a press release announcing positive results from a Phase 1 study of aritinercept (AUR200). 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, including Exhibits 99.1 and 99.2 attached hereto, are being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference into any of our filings under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date hereof, regardless of any general incorporation language in such filing. The furnishing of this information hereby shall not be deemed an admission as to the materiality of any such information.
The information contained in the press release and investor presentation is summary information that is intended to be considered in the context of our Securities and Exchange Commission filings and other public announcements that we may make, by press release or otherwise, from time to time. We undertake no duty or obligation to publicly update or revise such information, except as required by law.
| Item 9.01 | Financial Statements and Exhibits |
|---|
(d) Exhibits.
| Exhibit No. | Description |
|---|---|
| 99.1 | Aurinia Announces Positive Results from Phase 1 Study of Aritinercept (AUR200) |
| 99.2 | Aurinia's Investor Presentation, dated June 30, 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: June 30, 2025
| AURINIA PHARMACEUTICALS INC. | |
|---|---|
| By: | /s/ Stephen P. Robertson |
| Name: | Stephen P. Robertson |
| Title: | EVP, General Counsel, Corporate Secretary and Chief Compliance Officer |
Document
| Exhibit 99.1 |
|---|
Aurinia Announces Positive Results from Phase 1 Study of Aritinercept (AUR200)
Single Doses of Aritinercept Led to Robust and Long-Lasting Reductions in Immunoglobulins
Pharmacodynamic Effects Supportive of Once-Monthly Dosing
Plan to Initiate Clinical Studies in at Least Two Autoimmune Diseases in the Second Half of This Year
Aurinia to Host Conference Call Today, June 30, at 8:30 a.m. ET
ROCKVILLE, Md. & EDMONTON, Alberta--(BUSINESS WIRE)-- Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) today announced positive results from a Phase 1 single-ascending-dose (SAD) study of aritinercept (AUR200), its dual inhibitor of B cell-activating factor (BAFF) and a proliferation-inducing ligand (APRIL). The study investigated aritinercept doses of 5 mg, 25 mg, 75 mg, 150 mg, 225 mg and 300 mg and placebo, administered by subcutaneous injection, in 61 healthy subjects.
Aritinercept was well tolerated at all dose levels tested. There were no treatment-related Grade ≥3 adverse events, there were no treatment‑related serious adverse events (SAEs) and there were no discontinuations due to treatment-related adverse events. Adverse events that occurred in more than one subject included injection site reactions (24% aritinercept, 13% placebo), headache (11% aritinercept, 7% placebo), upper respiratory tract infection (7% aritinercept, 0% placebo) and back pain (4% aritinercept, 0% placebo). All injection site reactions were Grade 1.
Single doses of aritinercept led to robust and long-lasting reductions in immunoglobulins (antibodies). Specifically, mean reductions from baseline to Day 28 of up to 48%, 55% and 20% were observed for immunoglobulin A (IgA), immunoglobulin M (IgM) and immunoglobulin G (IgG), respectively.
“Dual inhibition of BAFF and APRIL to modulate B cells, including plasma cells, holds great promise in the treatment of a wide range of autoimmune immune diseases where these cells produce disease-causing autoantibodies,” said Dr. Greg Keenan, Chief Medical Officer of Aurinia. “Based on today’s positive results, which indicate robust and long‑lasting pharmacodynamic effects supportive of once-monthly dosing, we plan to initiate clinical studies of aritinercept in at least two autoimmune diseases in the second half of this year.”
Webcast & Conference Call Details
A webcast and conference call will be hosted today, June 30, at 8:30 a.m. ET. The link to the webcast is available here. To join the conference call, please dial 877-407-9170/+1 201-493-6756. Click here for participant International Toll-Free access numbers. 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 (AUR200), 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 the development of aritinercept 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
2
aritinerceptresultsfromp
June 30, 2025 Aritinercept (AUR200) A Dual BAFF/APRIL Inhibitor for the Potential Treatment of Autoimmune Diseases Results from a Phase 1 Study
Forward-Looking Statements This presentation 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 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 the development of aritinercept 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 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
Aritinercept (AUR200) 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 3
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 4
Aritinercept Is a High Affinity Dual BAFF/APRIL Inhibitor a Aritinercept has high binding affinity for both BAFF and APRIL as compared to the competitor dual BAFF/APRIL inhibitors Drug (Sponsor) BAFF APRIL Kd (pM) Compared to Aritinercept Kd (pM) Compared to Aritinercept Aritinercept (Aurinia) 117 N/A 25 N/A Atacicept (Vera) 919 7.9x 67 2.7x Telitacicept (RemeGen) 616 5.3x 82 3.3x a Morales et al., ACR Convergence 2022 5
Aritinercept Potently Inhibits BAFF- and APRIL-Mediated B Cell Proliferation a Aritinercept potently inhibits both BAFF- and APRIL-mediated B cell proliferation as compared to the competitor dual BAFF/APRIL inhibitors Drug (Sponsor) BAFF APRIL IC50 (nM) Compared to Aritinercept IC50 (nM) Compared to Aritinercept Aritinercept (Aurinia) 0.02 N/A 0.37 N/A Atacicept (Vera) 0.38 19.0x 2.15 5.8x Telitacicept (RemeGen) 1.05 52.5x 4.14 11.2x a Morales et al., ACR Convergence 2022 Atacicept Telitacicept Atacicept Telitacicept R e la ti v e L u m in e s c e n c e U n it s ( R L U s ) R e la ti v e L u m in e s c e n c e U n it s ( R L U s ) B Cell Proliferation in the Presence of BAFF B Cell Proliferation in the Presence of APRIL 6 Aritinercept Aritinercept
Vehicle 5 mg/kg 20 mg/kg 80 mg/kg Aritinercept Reduced Immunoglobulins in Non-Human Primates a After 4 weekly doses, IgA, IgM and IgG were lowered by up to 76%, 67% and 43% respectively Aritinercept was well-tolerated with no adverse findings at any of the doses tested a Morales et al., ACR Convergence 2022 7 Dosing Study Day Mean IgG reductions of up to 43% IgA IgM IgG 20% 0% -20% -40% -60% -80% -100% 0 7 14 21 28 35 42 49 56 0 7 14 21 28 35 42 49 56 20% 0% -20% -40% -60% -80% -100% DosingDosing 0 7 14 21 28 35 42 49 56 20% 0% -20% -40% -60% -80% -100% Study Day Mean IgA reductions of up to 76% M e a n C h a n g e f ro m B a s e li n e Mean IgM reductions of up to 67% Study Day
Aritinercept SAD Study Design 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) 8 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
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) 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 9
Pharmacokinetics Summary 10 a Geometric mean A half-life of 6-8 days after a single dose in the target dose range was observed 0 5 10 15 20 25 30 0 7 14 21 28 A ri ti n e rc e p t S e ru m C o n c e n tr a ti o n a (μ g /m L ) Study Day 25 mg SC 75 mg SC 150 mg SC 225 mg SC 300 mg SC
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 Single Doses of Aritinercept Led to Robust and Long-Lasting Reductions in Immunoglobulins in Humans 11 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%
20% 0% -20% -40% -60% Effect of a Single Dose of BAFF/APRIL Inhibitors on IgA 12 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); Willen et al., Eur J Drug Metab Ph 2020 (atacicept); Xie et al., Clin Pharm Drug Dev 2022 (telitacicept); Zhang et al., Clin Pharm Drug Dev 2023 (sibeprenlimab). 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) 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 13 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) 6% 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); Willen et al., Eur J Drug Metab Ph 2020 (atacicept); Xie et al., Clin Pharm Drug Dev 2022 (telitacicept); Zhang et al., Clin Pharm Drug Dev 2023 (sibeprenlimab). Dose levels for povetacicept, sibeprenlimab, atacicept and telitacicept represent dose levels selected by respective sponsors for Phase 3 development. 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 IgG 14 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) 7% 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); Willen et al., Eur J Drug Metab Ph 2020 (atacicept); Xie et al., Clin Pharm Drug Dev 2022 (telitacicept); Zhang et al., Clin Pharm Drug Dev 2023 (sibeprenlimab). Dose levels for povetacicept, sibeprenlimab, atacicept and telitacicept represent dose levels selected by respective sponsors for Phase 3 development. M e a n C h a n g e f ro m B a s e li n e
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 at least two autoimmune diseases in the second half of 2025 15
© Aurinia Pharmaceuticals Inc., 2025. All rights reserved. Trademarks and logos are the property of Aurinia Pharmaceuticals Inc.