On August 5, 2021 Berry Oncology Corporation reported that it completed a $99 million Series B round to support its portfolio of genomic testing products and services for oncology (Press release, Berry Oncology, AUG 5, 2021, View Source [SID1234586058]). In 2017, Berry Oncology was spun out from Berry Genomics, an early cancer screening firm. Its offerings include cancer genetic susceptibility analysis, early screening, plus companion diagnostics, response monitoring and prognosis predictions of targeted and immune therapies. With the new funding, the company has raised $309 million it total, the highest in its industry.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On August 5, 2021 Knight Therapeutics Inc. (TSX: GUD) ("Knight"), a leading pan-American (ex-US) specialty pharmaceutical company, reported that Samira Sakhia, President and Chief Operating Officer, is scheduled to present at Canaccord Genuity 41st Annual Growth Conference on Wednesday, August 11, 2021 at 3:00 pm ET, that will be held virtually (Press release, Knight Therapeutics, AUG 5, 2021, View Source [SID1234586050]). A copy of the investor presentation will be available at www.gud-knight.com.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On August 5, 2021 Merus N.V. (Nasdaq: MRUS) ("Merus", the "Company," "we", or "our"), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics), reported financial results for the second quarter that ended June 30, 2021 and provided a business update (Press release, Merus, AUG 5, 2021, View Source [SID1234586049]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are encouraged by the interim results on Zeno in patients with NRG1 fusion cancers that we reported in the second quarter and remain focused on successful execution of our Zeno program and our other clinical trials," said Bill Lundberg, M.D., President, Chief Executive Officer of Merus. "We are planning to provide a clinical update on MCLA-145 and MCLA-158 later this year."

Clinical Programs

Zenocutuzumab (Zeno or MCLA-128: HER3 x HER2 Biclonics)

Phase 2 part of the phase 1/2 trial continues: update planned by the first half of 2022

We shared interim clinical data of our zenocutuzumab (Zeno) program in patients with NRG1 fusion (NRG1+) cancers at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 Annual Meeting. The highlights from the presentation included:

As of the April 13, 2021, efficacy data cutoff, 61 patients with NRG1+ cancer were enrolled, including 45 patients evaluable for response.
Encouraging early clinical activity was observed, with confirmed partial responses by investigator review (RECIST v1.1) in 42% (5 of 12) patients with pancreatic cancer and in 29% (13 of 45) patients across all NRG1+ tumor types treated.
One additional partial response was confirmed after the data cutoff date, which if included in the interim efficacy analysis, would increase the percentage of confirmed partial responses across all NRG1+ tumor types treated to 31% (14 of 45 patients).
More than three quarters (34 of 45) of evaluable patients showed tumor reduction. In addition, 40% (19 of 47) of all patients remained on therapy as of the data cutoff date.
Zeno continues to be well tolerated with a favorable safety profile.
As of June 4, 2021, more than 70 patients had been treated in the eNRGy trial and Early Access Program (EAP). We continue to be encouraged by the ongoing trial, rate of enrollment, observed clinical activity and safety profile, and plan to provide a clinical and regulatory program update by the first half of 2022.

In the second quarter of 2021, we entered into collaborations with several companies and medical organizations in Israel, Italy and Spain with the goal of raising awareness of the eNRGy trial and providing access to molecular screening opportunities for eligible patients with cancers that may have NRG1 fusions. Merus is now working with more than ten different industry and academic collaborators across Asia, North America and Europe aimed to enhance testing for NRG1 fusions, to raise awareness of and support enrollment into the eNRGy trial.

Details of the eNRGy trial can be found at www.ClinicalTrials.gov and Merus’ trial website at www.nrg1.com, or by calling 1-833-NRG-1234.

MCLA-158 (Lgr5 x EGFR Biclonics): Solid Tumors

Phase 1 trial continues with dose expansion cohorts: update planned for Q4’21

The phase 1, open-label, multicenter clinical trial of MCLA-158 is ongoing in the dose expansion phase. Enrollment of patients with gastro-esophageal and head-and-neck cancers continues, and preliminary evidence of antitumor activity has been observed. We plan to provide an update at a medical conference in the fourth quarter of 2021.

MCLA-145 (CD137 x PD-L1 Biclonics): Solid Tumors

Phase 1 trial continues: update planned for Q4’21

The phase 1, open-label, single-agent clinical trial of MCLA-145 is ongoing and consists of a dose escalation phase, to be followed by a planned dose expansion phase. MCLA-145 is the first drug candidate co-developed under Merus’ global collaboration and license agreement with Incyte Corporation ("Incyte"), which permits the development and commercialization of up to 11 bispecific and monospecific antibodies from the Biclonics platform. Merus retains full rights to develop and commercialize MCLA-145, if approved, in the United States; and Incyte holds full rights to develop and commercialize MCLA-145 outside the United States. We plan to provide an update at a medical conference in the fourth quarter of 2021.

We published a report in Nature Communications in July titled "A human CD137×PD-L1 bispecific antibody promotes anti-tumor immunity via context dependent T cell costimulation and checkpoint blockade" demonstrating in preclinical models that MCLA-145 potently activates T cells, even in the presence of suppressive conditions, as well as enhances T cell priming and promotes long-term T cell immunity. In addition, the antitumor activity of MCLA-145 in in vivo models was superior to those of the current standard immune checkpoint inhibitor comparators and associated with recruitment and intratumoral expansion of CD8+ T cells.

MCLA-129 (EGFR x c-MET Biclonics): Solid Tumors

The phase 1/2, open-label, single-agent clinical trial of MCLA-129 is ongoing and consists of a dose escalation phase, to be followed by planned expansion cohorts evaluating MCLA-129 for the treatment of patients with advanced non-small cell lung cancer (NSCLC) and other solid tumors. MCLA-129 is a Biclonics, which binds to EGFR and c-MET and is being investigated for the treatment of solid tumors. EGFR is an important oncogenic driver in many cancers, and upregulation of c-MET signaling has been associated with resistance to EGFR inhibition.

Second Quarter 2021 Financial Results

We ended the second quarter with cash, cash equivalents and marketable securities of $352.8 million compared to $207.8 million at December 31, 2020. The increase was primarily the result of net proceeds from our follow-on offering and proceeds from the collaboration with and equity investment by Eli Lilly and Company ("Lilly"), net of cash used in operations and other items. Based on the Company’s current operating plan, we expect that our existing cash and cash equivalents and marketable securities of $352.8 million as of June 30, 2021, will fund the Company’s operations into the second half of 2024.

Collaboration revenue for the three months ended June 30, 2021 increased by $6.3 million as compared to the three months ended June 30, 2020, primarily as a result of an increase from a Lilly upfront payment amortization and reimbursement revenues of $4.6 million that commenced in the first quarter of 2021, and a $1.4 million increase primarily in reimbursement revenues related to Incyte reflecting activities in the period for MCLA-145. The change in exchange rates did not significantly impact collaboration revenue.

Research and development expense for the three months ended June 30, 2021 increased by $10.9 million as compared to the three months ended June 30, 2020, primarily as a result of an increase in clinical and manufacturing costs related to our programs and stock-based compensation.

General and administrative expense for the three months ended June 30, 2021 increased by $2.6 million as compared to the three months ended June 30, 2020, primarily as a result of an increase in stock-based compensation and other personnel related expenses as well as facilities and professional fees, partially offset by decreases in legal and IP related costs.

Collaboration revenue for the six months ended June 30, 2021 increased by $8.4 million as compared to the six months ended June 30, 2020, primarily as a result of an increase from a Lilly upfront payment amortization and reimbursement revenues of $6.0 million that commenced in the first quarter of 2021, and a $2.2 million increase primarily in reimbursement revenues related to Incyte reflecting activities in the period for MCLA-145. The change in exchange rates did not significantly impact collaboration revenue.

Research and development expense for the six months ended June 30, 2021 increased by $14.7 million as compared to the six months ended June 30, 2020, primarily as a result of an increase in clinical and manufacturing costs related to our programs and stock-based compensation.

General and administrative expense for the six months ended June 30, 2021 increased by $3.0 million as compared to the three months ended June 30, 2020, primarily as a result of an increase in stock-based compensation and other personnel related expenses as well as facilities and professional fees, partially offset by decreases in legal and IP related costs and travel expenses.

Other income (loss), net consists of interest earned and fees paid on our cash and cash equivalents held on account, accretion of investment earnings and net foreign exchange (losses) gains on our foreign denominated cash, cash equivalents and marketable securities. Other gains or losses relate to the issuance and settlement of financial instruments.

On August 5, 2021 Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical company with a robust pipeline of novel investigational therapeutics built on protein dysregulation expertise, reported financial results for the second quarter and first six months of 2021 (Press release, Prothena, AUG 5, 2021, View Source [SID1234586048]). In addition, the Company provided business highlights and updated 2021 financial guidance.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We continued to make significant progress advancing our robust portfolio with our confirmatory Phase 3 AFFIRM-AL trial of birtamimab in AL amyloidosis and new preclinical data presented at AAIC that highlighted two of our potentially best-in-class Alzheimer’s programs, PRX012, a high-potency anti-Aβ antibody designed for subcutaneous administration to enhance patient access and compliance, and our dual Aβ-tau vaccine for the prevention and treatment of Alzheimer’s," said Gene Kinney, Ph.D., President and Chief Executive Officer of Prothena. "Additionally, multiple strategic collaborations delivered milestones with a combined $200 million in partner payments this year from Roche, Bristol Myers Squibb and Novo Nordisk. Progress across our portfolio continues to validate our scientific platform and capital earned through our strategic partnerships helps to advance our robust pipeline through key milestones. As we continue to work towards our mission to bring novel therapies to patients in need of new treatment options, we welcomed Sanjiv Patel to our board, who brings significant industry experience to advise Prothena as we transition to a fully integrated research, development and commercial biotechnology company."

Second Quarter and Recent Business Highlights:

Multiple milestones from strategic collaborations

$60 million milestone from Roche for prasinezumab received in 2Q 2021
$80 million milestone from Bristol Myers Squibb for PRX005 expected in 3Q 2021
Up to $1.23 billion from Novo Nordisk for ATTR amyloidosis, including $60 million upfront payment received in 3Q 2021 and $40 million milestone expected 1H 2022
Birtamimab, a potential treatment for AL amyloidosis, is a humanized monoclonal antibody designed to directly neutralize soluble toxic aggregates and promote clearance of amyloid that causes organ dysfunction and failure

Confirmatory Phase 3 AFFIRM-AL study of birtamimab in Mayo Stage IV patients with AL amyloidosis (NCT#04973137)
Prasinezumab, a potential treatment for Parkinson’s disease, is a humanized monoclonal antibody designed to target a key epitope within the C-terminus of alpha-synuclein and is the focus of the worldwide collaboration with Roche

Earned $60 million clinical milestone payment upon dosing of the first patient in the global Phase 2b PADOVA study for prasinezumab, which was announced in May 2021 (NCT#04777331)
PRX004, a potential treatment for ATTR amyloidosis, is a humanized monoclonal antibody designed to deplete the pathogenic, non-native forms of the TTR protein, and is being developed by Novo Nordisk for the treatment of ATTR cardiomyopathy

Announced Novo Nordisk acquisition of ATTR amyloidosis business; Prothena is eligible to receive development and sales milestones up to $1.23 billion
Includes $100 million in upfront and near-term milestone payments (received $60 million upfront in 3Q 2021 and potential for $40 million upon initiation of Phase 2 study in ATTR cardiomyopathy patients)
PRX005, a potential treatment for Alzheimer’s disease (AD), is an investigational antibody that specifically targets a key epitope within the microtubule binding region (MTBR) of tau, a protein implicated in diseases including AD, frontotemporal dementia (FTD), progressive supranuclear palsy (PSP), chronic traumatic encephalopathy (CTE) and other tauopathies. PRX005 is part of the global neuroscience research and development collaboration with Bristol Myers Squibb

Bristol Myers Squibb exercised its option under the global neuroscience research and development collaboration and entered into an exclusive U.S. license for PRX005. Prothena is expected to receive $80 million from Bristol Myers Squibb in 3Q 2021.
Phase 1 study initiated
PRX012, a potential best-in-class treatment for AD, is a high-potency monoclonal antibody targeting a key epitope at the N-terminus of Aβ

Results presented at the Alzheimer’s Association International Conference 2021 (AAIC) demonstrated that PRX012 induced significant microglia-mediated clearance of both pyroglutamate-modified and -unmodified Aß plaque in brain tissue of late-stage AD patients at concentrations predicted to be clinically relevant. Both forms have been described as components of senile plaque and vascular Aβ in AD. PRX012 was observed to bind with very high affinity/avidity to full-length Aβ. PRX012 also showed higher potency and greater biologic activity than aducanumab in preclinical studies.
Dual Aβ-Tau vaccine, a potential prevention and treatment for Alzheimer’s disease, is a dual vaccine targeting key epitopes within the Aβ and tau proteins to promote amyloid clearance and blockade pathogenic tau interaction

Results presented at AAIC demonstrated Prothena’s dual Aβ-tau vaccine constructs generated appropriate antibody quantities with the ability to promote both phagocytosis of Aβ plaque and blockade of tau binding to a heparin-sulfate analog, which is a surrogate for neuronal uptake of tau. All three constructs generated a balanced immune response to both proteins, a common challenge with multi-epitope vaccines, and induced robust antibody titers to Aβ and tau in multiple animal experiments. The resultant titers strongly reacted with Aβ and tau pathology in human AD brain tissue. Additionally, cerebrospinal fluid (CSF) concentrations of tau and Aβ antibodies were within the expected range and similar to typical ranges achieved following administration of monoclonal antibodies (0.1-0.2% CSF/plasma).
Corporate

Appointed Sanjiv K. Patel, MBBS, MA, MBA, to its Board of Directors. Dr. Patel is President, Chief Executive Officer, and a member of the board of Relay Therapeutics, a clinical stage precision medicine company. Before joining Relay Therapeutics, Dr. Patel served in various roles at Allergan, Inc. for over a decade. He most recently served as Allergan’s Executive Vice President, Chief Strategy Officer and previously as Corporate Vice President, Global Strategic Marketing and Global Health Outcomes. Prior to this, he was a management consultant at The Boston Consulting Group and practiced as a surgeon within the UK’s National Health Service.
Upcoming Milestones:

Birtamimab

VITAL study 9-month results expected to be presented at a medical conference in 2021
Prasinezumab

Results from Part 2 of the PASADENA study expected to be presented at an upcoming medical conference
PRX004

$40 million milestone payment from Novo Nordisk for Phase 2 initiation expected 1H 2022
PRX005

$80 million option payment from Bristol Myers Squibb expected in 3Q 2021
Potential $55 million option payment from Bristol Myers Squibb for global rights at the end of Phase 1
PRX012

Investigational New Drug Application (IND) expected 1Q 2022
Dual Aβ-Tau vaccine

IND expected 2023
Second Quarter and First Six Months of 2021 Financial Results and Updated 2021 Financial Guidance

For the second quarter and first six months of 2021, Prothena reported a net income of $27.6 million and a net loss of $9.1 million, respectively, as compared to a net loss of $26.3 million and $49.9 million for the second quarter and first six months of 2020, respectively. Net income per share on a diluted basis for the second quarter of 2021 was $0.58 and net loss per share for the first six months of 2021, was $0.21, as compared to net loss per share of $0.66 and $1.25 for the second quarter and first six months of 2020, respectively.

Prothena reported total revenue of $60.1 million and $60.2 million for the second quarter and first six months of 2021, respectively, from collaboration and license revenue from Roche, as compared to total revenue of $0.2 million and $0.3 million for the second quarter and first six months of 2020, from collaboration and license revenue from Roche.

Research and development (R&D) expenses totaled $21.1 million and $42.2 million for the second quarter and first six months of 2021, respectively, as compared to $17.3 million and $32.5 million for the second quarter and first six months of 2020, respectively. The increase in R&D expense for the second quarter and first six months of 2021, compared to the same period in the prior year was primarily due to higher personnel expense, higher consulting expense, higher manufacturing expense primarily related to our PRX004 and PRX012 programs, higher clinical trial expense primarily related to birtamimab AFFIRM-AL trial, partially offset by lower PRX004 clinical trial expenses and lower collaboration expense with Roche related to the prasinezumab program as a result of the May 2021, cost share opt-out. R&D expenses included non-cash share-based compensation expense of $2.2 million and $4.2 million for the second quarter and first six months of 2021, respectively, as compared to $2.1 million and $4.1 million for the second quarter and first six months of 2020, respectively.

General and administrative (G&A) expenses totaled $11.0 million and $22.2 million for the second quarter and first six months of 2021, respectively, as compared to $9.7 million and $19.4 million for the second quarter and first six months of 2020, respectively. The increase in G&A expenses for the second quarter and first six months of 2021 compared to the same period in the prior year was primarily related to higher personnel expense, higher legal expense and higher expense for our director and officer insurance premium. G&A expenses included non-cash share-based compensation expense of $3.3 million and $7.5 million for the second quarter and first six months of 2021, respectively, as compared to $3.6 million and $7.1 million for the second quarter and first six months of 2020, respectively.

Total non-cash share-based compensation expense was $5.5 million and $11.7 million for the second quarter and first six months of 2021, respectively, as compared to $5.7 million and $11.2 million for the second quarter and first six months of 2020.

As of June 30, 2021, Prothena had $402.5 million in cash, cash equivalents and restricted cash (does not include the $60 million upfront payment from Novo Nordisk received in 3Q 2021 or the $80 million from Bristol Myers Squibb for the exclusive U.S. license to PRX005 expected in 3Q 2021) and no debt.

As of July 29, 2021, Prothena had approximately 45.0 million ordinary shares outstanding.

The Company is updating its projected full year 2021 net cash burn from operating and investing activities (prior guidance of $51 to $74 million) to net cash provided by operating and investing activities of $85 to $95 million and expects to end the year with approximately $491 million in cash, cash equivalents and restricted cash (midpoint) representing an increase of $175 million from prior guidance of $316 million. This increase in cash position is primarily driven by an $80 million milestone payment from Bristol Myers Squibb expected in 3Q 2021 for the exclusive U.S. license to PRX005 and a $60 million payment received from Novo Nordisk in 3Q 2021 for the acquisition of Prothena’s ATTR amyloidosis business, which are both included in operating activities. The updated estimated full year 2021 net cash provided by operating and investing activities is primarily driven by an updated estimated net income of $50 to $60 million (versus prior net loss guidance of $79 to $111 million), which includes the payments from Bristol Myers Squibb and Novo Nordisk mentioned above, as well as an estimated $25 million of non-cash share-based compensation expense.

On August 5, 2021 Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) ("Aurinia" or the "Company") reported its financial results for the second quarter ended June 30, 2021 (Press release, Aurinia Pharmaceuticals, AUG 5, 2021, View Source [SID1234586047]). Amounts, unless specified otherwise, are expressed in U.S. dollars.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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

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

Recent Highlights

Second Quarter 2021 U.S. Commercial Activities

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

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

Aurinia anticipates reporting top-line results from the ongoing AURORA-2 two-year continuation study of voclosporin for the treatment of LN by the end of 2021.
Financial Liquidity at June 30, 2021

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

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

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

Financial Results for the Quarter Ended June 30, 2021

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

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

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

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

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

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

Conference Call Details

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

About Lupus Nephritis

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