On November 3, 2022 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 third quarter that ended September 30, 2022 and provided a business update (Press release, Merus, NOV 3, 2022, View Source [SID1234623123]).

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"We continue to advance numerous programs which now demonstrate important clinical activity across the portfolio," said Bill Lundberg, M.D., President, Chief Executive Officer of Merus. "For MCLA-129, we have recently shared early efficacy and safety data at the ENA ‘triple’ meeting and are now enrolling expansion cohorts in lung and other cancers; for Zeno, potentially first and best in class for NRG1 fusion cancer, we are continuing to enroll the eNRGy study consistent with recent feedback from the FDA; and for petosemtamab, we are looking forward to providing a clinical update in the first half of 2023. Later this year, Incyte plans to start a clinical study of INCA32459, a novel LAG3xPD-1 bispecific antibody developed in collaboration with Merus."

Zenocutuzumab (Zeno or MCLA-128: HER3 x HER2 Biclonics): NRG1+ cancer and other solid tumors
Enrollment continues in the eNRGy trial; enrollment in combination study in NRG1+ NSCLC as well as monotherapy in castration resistant prostate cancer (CRPC) planned to begin enrollment in 4Q2022

At the end of October, Merus met with the U.S. Food and Drug Administration (FDA) regarding a potential Biologics License Application (BLA) filing for Zeno in NRG1 fusion (NRG1+) cancer. Based on the FDA feedback, Merus believes that a potential registrational path remains viable in a NRG1+ cancer tumor agnostic indication or separate applications for NRG1+ lung and NRG1+ pancreatic cancer, which could then be followed by a potential tumor agnostic filing. The majority of the eNRGy trial and Early Access Program enrollment to date has been NRG1+ non-small cell lung cancer (NSCLC) and NRG1+ pancreatic cancer. The FDA recommended that Merus enroll additional patients under either approach (tissue agnostic or tumor-type specific), to obtain further supportive data for a potential registrational data set, consistent with the recent FDA draft guidance on Tissue Agnostic Drug Development in Oncology. The amount of data needed for a potential filing under either approach will depend upon the magnitude and durability of responses and the overall risk benefit assessment.

Merus is assessing the impact on the timeline for a potential BLA filing for Zeno in NRG1+ cancer. Enrollment continues in the phase 1/2 eNRGy trial to assess the safety and anti-tumor activity of Zeno monotherapy in NRG1+ cancers. Merus believes Zeno has the potential to be a first and best in class and a new standard of care for patients with NRG1+ cancer.

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.

Further, Merus is initiating a clinical trial evaluating Zeno in combination with afatinib for NRG1+ NSCLC, and a clinical trial evaluating Zeno outside of NRG1+ cancer, as a treatment for castration resistant prostate cancer. The Company is also actively exploring the ways in which targeting both HER2 and HER3 with Zeno has potential for the treatment of other cancers.

Petosemtamab (MCLA-158: Lgr5 x EGFR Biclonics): Solid Tumors
Dose expansion continues in the phase 1 trial: clinical update planned for 1H2023

Petosemtamab is currently enrolling patients with advanced solid tumors in the expansion phase of a phase 1 open-label, multicenter study.

Merus plans to provide a clinical update for petosemtamab at a medical conference in the first half of 2023. The planned presentation will provide the opportunity to present a robust update across the program, including approximately 40 patients with head and neck squamous cell carcinoma (HNSCC) with meaningful clinical follow up, and an update on the gastro-esophageal cohort, to inform clinical development strategy and planned regulatory interactions.

MCLA-145 (CD137 x PD-L1 Biclonics): Solid Tumors
Phase 1 trial continues including in combination with a PD1 inhibitor

MCLA-145 is currently enrolling a global, phase 1, open-label, single-agent clinical trial evaluating MCLA-145 in patients with solid tumors. The trial consists of a dose escalation phase, followed by a planned dose expansion phase. Merus is also evaluating the combination of MCLA-145 with a PD-1 blocking antibody, with first patient dosed and enrollment ongoing.

MCLA-129 (EGFR x c-MET Biclonics): Solid Tumors
Phase 1 continues with enrollment in expansion cohorts

MCLA-129 is currently enrolling patients in a phase 1/2, open-label clinical trial evaluating patients with MCLA-129 monotherapy in MetEx14 NSCLC, EGFRex20 NSCLC, and in HNSCC, as well as in combination with a third generation EGFR TKI in treatment naïve EGFR mutant (m) NSCLC and in patients with EGFR m NSCLC that have progressed on Tagrisso (osimertinib).

Merus presented initial clinical data regarding MCLA-129 at the 34th EORTC/NCI/AACR (ENA) Symposium. Twenty patients, (14 patients with EGFR m lung cancer, 2 with c-MET exon 14 skipping m NSCLC, 1 patient with c-MET amplified gastric adenocarcinoma, 1 patient with esophageal squamous cell cancer, 2 patients with HNSCC), were treated with MCLA-129 across dose levels of 100 mg-1500 mg. As of an August 15, 2022 data cutoff date, these initial clinical data in 18 evaluable patients show clinical activity at a variety of dose levels with two confirmed partial responses and four additional patients with >20% tumor shrinkage. MCLA-129 was observed to be well tolerated with no dose limiting toxicities. The most frequent adverse events (AEs) observed were infusion-related reactions (IRR); 90% of patients experienced IRR AEs of any grade, one patient (5%) experienced a grade 3, no grade 4 or 5 AEs were observed. Based on pharmacokinetic and pharmacodynamic data, and the safety profile, an initial recommend phase 2 dose was selected at 1500 mg every two weeks. As of the data cutoff date the median duration of exposure was 12.6 weeks and six of 20 patients remained on treatment.

As October 2022, 33 patients have been enrolled in the dose escalation and dose expansion phases of the trial. The additional 13 patients enrolled did not yet have an opportunity to be evaluated as of the August 15, 2022 data cutoff.

MCLA-129 is also subject to a collaboration and license agreement with Betta Pharmaceuticals Co. Ltd. (Betta), which permits Betta to exclusively develop MCLA-129 in China, while Merus retains global rights outside of China.

Collaborations

Incyte

Since 2017, Merus has been working together with Incyte Corporation under global collaboration and license agreement, which grants Incyte exclusive rights for up to ten bispecific and monospecific antibody programs from Merus’ Biclonics platform. The collaboration is progressing, with multiple programs in various stages of preclinical development. Further, Incyte announced this quarter that it plans to start a clinical study of INCA32459, a novel Lag3xPD-1 bispecific antibody developed in collaboration with Merus using Merus’ Biclonics antibody platform. For each program under the collaboration, Merus receives reimbursement for research activities and is eligible to receive potential development, regulatory and commercial milestones and sales royalties for any products, if approved.

Loxo Oncology at Lilly

In January 2021 Merus and Loxo Oncology at Lilly, a research and development group of Eli Lilly and Company (Lilly) announced a research collaboration and exclusive license agreement to develop up to three CD3-engaging T-cell re-directing bispecific antibody therapies utilizing Merus’ Biclonics platform and proprietary CD3 panel along with the scientific and rational drug design expertise of Loxo Oncology at Lilly. The collaboration is progressing with multiple active research programs underway.

Cash Runway, Merus expects to be funded beyond 2024

As of September 30, 2022, Merus had $372.9 million cash and cash equivalents sufficient to fund company operations beyond 2024.

Third Quarter 2022 Financial Results

Collaboration revenue for the three months ended September 30, 2022 decreased by $7.1 million as compared to the three months ended September 30, 2021, primarily as a result of a decrease in Lilly upfront payment amortization and reimbursement revenues and Incyte upfront payment amortization. The change in exchange rates did not significantly impact collaboration revenue.

Research and development expense for the three months ended September 30, 2022 increased by $16.3 million as compared to the three months ended September 30, 2021, primarily as a result of an increase in external clinical services and drug manufacturing costs.

General and administrative expense for the three months ended September 30, 2022 increased by $2.3 million as compared to the three months ended September 30, 2021, primarily as a result of an increase in stock-based compensation expense and consulting costs.

Collaboration revenue for the nine months ended September 30, 2022 decreased by $3.5 million as compared to the nine months ended September 30, 2021, primarily in Lilly upfront payment amortization and reimbursement revenues and Incyte upfront payment amortization.

Research and development expense for the nine months ended September 30, 2022 increased by $29.0 million as compared to the nine months ended September 30, 2021, primarily as a result of an increase in external clinical services and drug manufacturing costs.

General and administrative expense for the nine months ended September 30, 2022 increased by $6.8 million as compared to the nine months ended September 30, 2021, primarily as a result of an increase in stock-based compensation expense, personnel related expenses, and consultancy costs.

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 November 3, 2022 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, reported that it will report its third quarter 2022 financial results on Thursday, November 10, 2022 and will provide a business update (Press release, Altimmune, NOV 3, 2022, View Source [SID1234623122]).

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Altimmune management will host a conference call at 8:30 am E.T. on November 10 to discuss financial results and provide a business update. The conference call will be webcast live on Altimmune’s Investor Relations website at View Source

Participants who would like to join the call may register here to receive the dial-in numbers and unique PIN to access the call. Shortly after the call, a replay will be available on the Investor Relations website for up to twelve months.

On November 3, 2022 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported its operational and financial results for the third quarter ended September 30, 2022 (Press release, Autolus, NOV 3, 2022, View Source [SID1234623121]).

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"Autolus has continued to deliver further strategic and operational progress during the third quarter of 2022, with our pivotal FELIX trial on track for a Q4 2022 update, the commercial manufacturing facility build on schedule for the handover of the first clean rooms to Autolus, and the announcement post-period end of an agreement for our proprietary technology with Bristol Myers Squibb and an option exercise by Moderna," said Dr. Christian Itin, CEO of Autolus "Alongside this, we have continued progressing our pipeline candidates through Phase 1 clinical trials through our long-standing collaboration with UCL, laying the foundations for our clinical pipeline beyond obe-cel. We are looking forward to updating the market with our progress over the coming months as we remain fully focused on bringing obe-cel to market."

Key Pipeline Programs:

Obecabtagene autoleucel (obe-cel) in relapsed / refractory (r/r) adult ALL – The FELIX Trial
The pivotal FELIX Phase 2 clinical trial is on track to report initial results in Q4 2022. Autolus plans to present FELIX Phase 2 data at a medical conference in mid-2023. Assuming a positive outcome from the FELIX trial, the Company expects the data to form the basis of a Biologics License Application (BLA) submission for obe-cel to the FDA at the end of 2023.
Obe-cel in r/r adult ALL patients – ALLCAR19 Trial
In collaboration with University College London (UCL), Autolus expects to present long term follow-up data from the Phase 1 ALLCAR19 trial in Q4 2022 at the 2022 ASH (Free ASH Whitepaper) meeting, to be held December 10-13, 2022. Abstracts will be online November 3, 2022 at 09:00 am ET/1:00 pm GMT.
Obe-cel in r/r B-NHL patients – ALLCAR19 Extension Trial
In collaboration with UCL, patients continue to be enrolled into the Phase 1 ALLCAR19 extension trial. Data were presented at the European Hematology Congress (EHA) (Free EHA Whitepaper) in June 2022, and longer-term follow up will be presented at the 2022 ASH (Free ASH Whitepaper) meeting in December. Abstracts will be online November 3, 2022 at 09:00 am ET/1:00 pm GMT.
Obe-cel in Primary CNS Lymphoma patients – CAROUSEL Trial
In collaboration with UCL, patients continue to be enrolled into the Phase 1 CAROUSEL trial. Data were presented at EHA (Free EHA Whitepaper) in June 2022 – and longer-term follow up data is planned in 2023.
AUTO1/22 in pediatric ALL patients – CARPALL Trial
In collaboration with UCL, patients continue to be enrolled into the AUTO1/22 Phase 1 CARPALL trial. Data were presented at EHA (Free EHA Whitepaper) in June 2022, and longer-term follow up data will be presented at the 2022 ASH (Free ASH Whitepaper) Meeting in December. Abstracts will be online November 3, 2022 at 09:00 am ET/1:00 pm GMT.
AUTO4 in T Cell Lymphoma patients – LibrA T1 Trial
Autolus has optimized the manufacturing process for AUTO4, and is currently enrolling additional patients into the trial to test this manufacturing change. Data were presented at EHA (Free EHA Whitepaper) in June 2022, and longer-term follow up data will be presented at the 2022 ASH (Free ASH Whitepaper) Meeting in December. Abstracts will be online November 3, 2022 at 09:00 am ET/1:00 pm GMT.
AUTO8 in Multiple Myeloma – MCARTY Trial
In collaboration with UCL, patients continue to be enrolled into the AUTO8 Phase 1 clinical trial, with first data expected in H2 2023.
AUTO6NG in Neuroblastoma – MCARGD2 Trial
In collaboration with UCL, the first patient is expected to be dosed in the Phase 1 MCARGD2 clinical trial in H1 2023, with initial data expected towards the end of 2023.
Key Operational Updates during Q3 2022

The build phase of the Company’s new 70,000 square foot commercial manufacturing facility in Stevenage, UK has continued to progress on track with the planned schedule during Q3 2022, with Phase 1 of the buildout scheduled to complete in Q4 2022. This first phase includes the first of three cell product commercial manufacturing clean rooms in Stevenage. Final equipment installations and qualification by Autolus are on track for the commencement of Good Manufacturing Practice (GMP) operations in H2 2023. This facility has been designed for a capacity of 2,000 batches per year with the option to expand capacity as needed.
Autolus is on schedule to complete the development work and report generation for the Chemistry Manufacturing and Controls (CMC) package planned to be submitted to the FDA. All work including process qualification activities in the new Stevenage facility are on track for submission of a BLA by the end of 2023.
Post Period End:

In October 2022, Autolus announced a new collaboration with Bristol Myers Squibb, and the exercise of an option by Moderna under an existing license and option agreement announced in August 2021. These two technology deals underscore the scientific capabilities and expertise at Autolus.

Bristol Myers Squibb entered into a licensing agreement with Autolus for access to the Company’s proprietary RQR8 rituximab-induced safety switch for incorporation into a set of selected cell therapy programs, in return for an upfront payment, with potential for near term option exercise fees and development milestone payments plus royalties.

Moderna exercised an option on one of the proprietary binders being developed against an undisclosed immuno-oncology target for the delivery of pioneering messenger RNA (mRNA) therapeutics, in return for an upfront payment, development and commercial milestone payments for each product successfully commercialized, as well as royalties on net sales of all products commercialized under the agreement.

This license option stems from a deal announced on August 2, 2021, granting Moderna an exclusive option to license Autolus’ proprietary binders for incorporation in certain mRNA therapeutics.
Financial Results for the Quarter Ended September 30, 2022

Cash at September 30, 2022, totaled $163.1 million, as compared to cash of $310.3 million at December 31, 2021. Post period end the company received $19.1m in relation to its 2021 U.K research and development tax credit claim.

Net total operating expenses for the three months ended September 30, 2022, were $43.5 million, which included license revenue income of $2.4 million, as compared to net operating expenses of $40.4 million, which included grant income of $0.2 million, for the same period in 2021.

Research and development expenses increased by $5.3 million to $37.6 million for the three months ended September 30, 2022 from $32.3 million for the three months ended September 30, 2021 primarily due to:

an increase of $3.6 million in clinical costs and manufacturing costs primarily relating to the Company’s obe-cel clinical product candidate,
an increase of $2.0 million in salaries and other employment related costs including share-based compensation expense, which was mainly driven by an increase in the number of employees engaged in research and development activities,
an increase of $0.8 million in legal fees and professional consulting fees in relation to the Company’s research and development activities,
an increase of $0.2 million related to information technology infrastructure and support for information systems related to the conduct of clinical trials and manufacturing operations.
a decrease of $0.7 million in facilities costs related to the termination and closure of the Company’s US manufacturing facility in 2021 and a shift in the Company’s overall manufacturing strategy, and
a decrease of $0.6 million in depreciation and amortization related to property, plant and equipment and intangible assets.
General and administrative expenses decreased by $0.1 million to $8.2 million for the three months ended September 30, 2022 from $8.3 million for the three months ended September 30, 2021 primarily due to:

an increase of $1.0 million in salaries and other employment related costs including share-based compensation expenses, which was mainly driven by an increase in the number of employees engaged in general and administrative activities,
an increase of $0.1 million in facilities costs due to the increased space utilized for general and administrative activities,
a decrease of $1.1 million primarily related to a reduction in directors’ and officers’ liability insurance premiums, as well as reduced professional fees and information technology costs, and
a decrease of $0.1 million in depreciation and amortization related to property, plant and equipment and intangible assets.
Other (expense) / income net, decreased to an expense of $3.7 million from an income of $1.0 million for the three months ended September 30, 2022 and 2021, respectively. The decrease of $4.7 million is primarily due to the weakening of the pound sterling relative to the U.S. dollar exchange rate during the three month period.

Interest expense increased to $1.9 million for the three months ended September 30, 2022 and relates primarily to the liability related to sale of future royalties and sales milestones which arose upon the Company’s entry into the strategic collaboration and financing agreement with Blackstone, in November 2021. There was no interest expense during the comparable period in 2021.

Income tax benefit increased by $0.8 million to $6.2 million for the three months ended September 30, 2022 from $5.4 million for the three months ended September 30, 2021 due to an increase in qualifying research and development expenditures for the quarter.

Net loss attributable to ordinary shareholders was $42.8 million for the three months ended September 30, 2022, compared to $34.0 million for the same period in 2021. The basic and diluted net loss per ordinary share for the three months ended September 30, 2022, totaled $(0.47) compared to a basic and diluted net loss per ordinary share of $(0.47) for the three months ended September 30, 2021.

Autolus estimates that its current cash on hand and anticipated milestone payments in the relevant period from Blackstone extends the Company’s runway into 2024.

Conference Call

Management will host a conference call and webcast at 8:30 am ET/12:30 pm GMT to discuss the Company’s financial results and provide a general business update. Conference call participants should pre-register using this link to receive the dial-in numbers and a personal PIN, which are required to access the conference call. The webcast can be accessed at this link.

A simultaneous audio webcast and replay will be accessible on the events section of Autolus’ website.

On November 3, 2022 Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) reported its financial results for the three months ended September 30, 2022 (Press release, Aurinia Pharmaceuticals, NOV 3, 2022, View Source [SID1234623120]). Amounts, unless specified otherwise, are expressed in U.S. dollars.

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Total net revenue was $55.8 million for the three months ended September 30, 2022, compared to $14.7 million for the same period ended September 30, 2021. Revenues for the three months ended September 30, 2022 included net product revenues of $25.5 million and license and collaboration revenue of $30.3 million.

"During the third quarter, we demonstrated progress across many key commercial metrics for LUPKYNIS, including an increased total number of patients on therapy, improved patient start form conversion rates and processing speed, and sustained patient adherence, in comparison to the second quarter ended June 30, 2022. Unfortunately, we experienced a slight decline in new patient start forms over the second quarter ended June 30, 2022, which is potentially the result of reduced lupus nephritis diagnoses and patient visits in the quarter," said Peter Greenleaf, President and Chief Executive Officer of Aurinia. "Given these current market dynamics, we are adjusting our net revenue guidance to $100-105 million from sales of LUPKYNIS for 2022. We are also providing preliminary net revenue guidance from product sales of LUPKYNIS for 2023 in the range of $120-140 million."

Mr. Greenleaf continued, "In addition to our U.S. commercial efforts, we have also made meaningful advancement in our planned globalization for LUPKYNIS, highlighted by the European Commission Marketing Authorization for LUPKYNIS for the treatment of adults with active lupus nephritis in Europe in September 2022. Working with Otsuka, we expect to achieve continued important regulatory milestones in additional geographies in 2022 and 2023."

Third Quarter 2022 and Recent Highlights

There were approximately 1,354 patients on LUPKYNIS therapy at September 30, 2022, compared with 1,274 at June 30, 2022.
Aurinia added 374 patient start forms (PSFs) during the third quarter 2022, as compared to 412 in the third quarter of 2021. As of Monday, October 31, 2022, the Company recorded 1,357 total PSFs since January 1, 2022.
PSF conversion rates after 90 days, adherence rates and confirmed patient access remain at peak levels since launch.
Persistency rates at 6 months and at 9 months remain reasonable consistent with prior periods, at approximately, 70% and 60%, respectively. At 12 months post-treatment-start, an average of approximately 50% of patients remain on treatment.
The European Commission (EC) granted Marketing Authorization for LUPKYNIS to Otsuka for the treatment of adults with active lupus nephritis in Europe in September 2022. The centralized marketing authorization is valid in all European Union (EU) member states as well as in Iceland, Liechtenstein, Norway and Northern Ireland.
The Company recognized a one-time $30.0 million EC approval-related milestone in connection with its collaboration and licensing agreement with its partner Otsuka Pharmaceuticals Co., Ltd., during the quarter, which was subsequently received on October 31, 2022. In addition to the milestone, the Company began recognizing revenue for the supply of product and certain reimbursable collaboration activities under a cost-plus arrangement. Going forward the Company will be eligible to receive further payments tied to additional regulatory and reimbursement milestones, along with low double digit royalties on future net sales.
Additional clinical data, including updates from AURORA 1 and AURORA 2, are expected to be presented at upcoming conferences, including LUPUS, the American College of Rheumatology Convergence 2022, and, the American Society of Nephrology.
Key ongoing clinical updates for LUPKYNIS include the advancement of both the VOCAL pediatric study and the ENLIGHT-LN registry. With the registry, which we just initiated at the beginning of the year, we now have 38 activated sites toward our goal of having 75 sites total. As a reminder, we plan to leverage real-world data collected from this study to gain further knowledge about patients taking LUPKYNIS and help clinicians and payers to improve patient care and ensure access to therapy. We also remain on track to meet our post approval FDA commitments.
As previously reported, on July 26, 2022 the U.S. Patent Office Patent Trial and Appeal Board (PTAB) determined to institute an inter partes review (IPR) petition filed by Sun Pharmaceuticals. On October 20, 2022 the PTAB notified the Company that they have denied our rehearing appeal for the institution decision. This follows a prior denial of our precedential opinion panel appeal, which was received on October 5, 2022. The IPR is related to a patent claiming LUPKYNIS dosing protocol that extends patent protection on LUPKYNIS in the United States to 2037. The Company is diligently working on its defense to the IPR, which will be filed after market on November 4, 2022. The defense will address all challenges raised in the IPR process. A determination on patentability, relative to the IPR, is expected on or prior to July 26, 2023.

Financial Results for the Three and Nine Months Ended September 30, 2022

Total net revenue was $55.8 million and $14.7 million for the three months ended September 30, 2022 and September 30, 2021, respectively. Total net revenue was $105.6 million and $22.2 million for the nine months ended September 30, 2022 and September 30, 2021, respectively. The increase in both periods is primarily due to the recognition of a $30.0 million regulatory milestone from Otsuka following the EC marketing authorization of LUPKYNIS in September 2022, coupled with an increase in product sales to our two main customers for LUPKYNIS, which was driven predominantly by further penetration in the lupus nephritis market.

Total cost of sales and operating expenses for the three months ended September 30, 2022 and September 30, 2021 were $65.3 million and $65.0 million, respectively. Total cost of sales and operating expenses were $189.0 million and $170.2 million for the nine months ended September 30, 2022 and September 30, 2021, respectively. Further breakdown of operating expenses drivers and fluctuations are highlighted in the following paragraphs.

Cost of sales were $2.4 million and $0.3 million for the three months ended September 30, 2022 and September 30, 2021, respectively. Cost of sales were $4.3 million and $0.6 million for the nine months ended September 30, 2022 and September 30, 2021, respectively. The increase for both periods was primarily due to an increase in product related revenue, coupled with safety stock inventory reserves.

Gross margin for the three months ended September 30, 2022 and September 30, 2021 was approximately 96% and 98% respectively. Gross margin for the nine months ended September 30, 2022 and September 30, 2021 was approximately 96% and 97%, respectively.

Selling, general and administrative (SG&A) expenses, inclusive of share-based compensation, were $52.2 million and $44.6 million for the three months ended September 30, 2022 and September 30, 2021, respectively. For the nine months ended September 30, 2022 and September 30, 2021, SG&A expenses, inclusive of share-based compensation, were $148.9 million and $128.8 million, respectively. The primary drivers for the increase for both periods ended September 30, 2022 as compared to September 30, 2021 were an increase in professional fees and services related to corporate legal matters, and travel and sponsorships to support the commercialization of LUPKYNIS. For the nine months ended September 30, 2022, the primary drivers were salaries, incentive pay and employee benefits due to employee related expenses such as increased headcount, promotions and inflation, along with an increase in professional fees for corporate legal matters and travel related costs, which increased once the impacts from COVID started to normalize.

Non-cash SG&A share-based compensation expense included above for the three months ended September 30, 2022 and September 30, 2021 was $6.6 million and $6.0 million, respectively. Non-cash SG&A share-based compensation expense included above for the nine months ended September 30, 2022 and September 30, 2021 was $21.5 million and $19.2 million, respectively.

Research and Development (R&D) expenses, inclusive of share-based compensation, were $11.0 million and $20.1 million for the three months ended September 30, 2022 and September 30, 2021, respectively. For the nine months ended September 30, 2022 and September 30, 2021, R&D expenses, inclusive of share-based compensation expense, were $35.1 million and $40.0 million, respectively. The primary drivers for the decrease were the upfront license and accrued milestone expense for AUR300 from the periods ended September 30, 2021 offset year to date by additional developmental expenses related to AUR200 and AUR300 for the periods ended September 30, 2022. In accordance with U.S. GAAP, AUR300 was recorded as an asset acquisition during the period ended September 30, 2021 and expensed as R&D expense at the acquisition date.

Non-cash R&D share-based compensation expense included above for the three months ended September 30, 2022 and September 30, 2021 was $1.5 million and $1.0 million, respectively. Non-cash R&D share-based compensation expense included above for the nine months ended September 30, 2022 and September 30, 2021 was $3.5 million and $3.2 million, respectively.

Interest income was $1.5 million and $0.1 million for the three months ended September 30, 2022 and September 30, 2021, respectively. Interest income was $2.2 million and $0.4 million for the nine months ended September 30, 2022 and September 30, 2021, respectively. The increase in both periods is due to higher yields on our investments as a result of increasing interest rates.

For the three months ended September 30, 2022, Aurinia recorded a net loss of $9.0 million or $0.06 net loss per common share, as compared to a net loss of $50.3 million or $0.39 net loss per common share for the quarter ended September 30, 2021. For the nine months ended September 30, 2022, Aurinia recorded a net loss of $82.1 million or $0.58 net loss per common share, as compared to a net loss of $147.6 million or $1.15 net loss per common share for the nine months ended September 30, 2021.

Financial Liquidity at September 30, 2022

As of September 30, 2022, Aurinia had cash, cash equivalents and restricted cash and investments of $376.6 million compared to $466.1 million at December 31, 2021. The decrease in cash, cash equivalents and restricted cash and investments is primarily related to the continued investment in commercialization activities, advancement of our pipeline and a payment for the achievement of a one-time milestone, partially offset by an increase in cash receipts from sales of LUPKYNIS.

Aurinia believes that it has sufficient financial resources to fund its operations, which include funding commercial activities, including FDA related post approval commitments, manufacturing and packaging of commercial drug supply, funding its supporting commercial infrastructure, advancing its R&D programs and funding its working capital obligations for at least the next few years.

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 September 30, 2022 in the Company’s Quarterly Report on Form 10-Q, which will be 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 September 30, 2022 financial results today, Thursday, November 3, 2022 at 8:30 a.m. ET. The audio webcast can be accessed under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. In order to participate in the conference call, please dial +1 (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 manifestation of SLE, a chronic and complex autoimmune disease. About 200,000-300,000 people live with SLE in the U.S. and about one-third of these people are diagnosed with lupus nephritis at the time of their SLE diagnosis. About 50 percent of all people with SLE may develop lupus nephritis. If poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney. Black and Asian individuals with SLE are four times more likely to develop LN and individuals of Hispanic ancestry are approximately twice as likely to develop the disease when compared with Caucasian individuals. Black and Hispanic individuals with SLE also tend to develop LN earlier and have poorer outcomes when compared to Caucasian individuals.

On November 4, 2022 Redx (AIM:REDX), the clinical-stage biotechnology company focused on discovering and developing novel, small molecule, highly targeted therapeutics for the treatment of cancer and fibrotic disease, reported that it will present a poster on the combination module of the Phase 1 clinical study (clinicaltrials.gov NCT03447470) of RXC004 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Conference (8-12 November 2022, Boston, MA) (Press release, Redx Pharma, NOV 4, 2022, View Source [SID1234623109]).

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The poster will present results from the combination module of the Phase 1 clinical study in which RXC004 was combined with nivolumab, an anti-PD-1 antibody, in patients with advanced solid tumours. RXC004 is a clinical stage, highly potent and selective, orally active Porcupine inhibitor being developed as a targeted therapy for Wntligand dependent cancer.

RXC004 is currently being evaluated in two Phase 2 proof-of-concept clinical studies in genetically selected metastatic colorectal cancer (mCRC) (clinicaltrials.gov NCT04907539), and in biliary tract cancers and genetically selected pancreatic cancer (clinicaltrials.gov NCT04907851). Following the completion of this Phase 1 combination study, the Company will now initiate enrolment into combination cohorts of RXC004 with anti-PD-1 antibodies in mCRC and biliary tract cancers, within these Phase 2 studies.