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Aurinia Pharmaceuticals Reports Third Quarter and Nine Months 2023 Financial and Operational Results

On November 2, 2023 Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) reported its financial results for the three and nine months ended September 30, 2023 (Press release, Aurinia Pharmaceuticals, NOV 2, 2023, View Source [SID1234636733]). Amounts are expressed in U.S. dollars.

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Net product revenue was $40.8 million for the three months ended September 30, 2023 and $25.5 million for the same period in 2022, representing growth of approximately 60%. Net product revenue was $116.2 million for the nine months ended September 30, 2023 and $75.1 million for the same period ended 2022, representing growth of approximately 55%.

Total net revenue was $54.5 million for the three months ended September 30, 2023 and $55.8 million for the same period in 2022. Total net revenue was $130.4 million for the nine months ended September 30, 2023 and $105.6 million for the same period in 2022.

"We are very pleased with our overall results for the first nine months of the year. Reporting another strong quarter of results reinforces our ability to execute and deliver against key metrics. Our team continues to focus on business fundamentals and steady performance," said Peter Greenleaf, President, and Chief Executive Officer of Aurinia. "We continue to deliver new data on LUPKYNIS and grow the overall LN market. In addition, we received a $10.0 million milestone from our collaboration partner outside the U.S. as a result of securing pricing and reimbursement approvals in three of the five major European markets."

For the fiscal year 2023, the Company is narrowing its net product revenue guidance to a range of $155 – $160 million for net product sales of LUPKYNIS. This guidance range is based on assumptions regarding PSF run rates, consistent conversion rates, time to convert, persistency and pricing.

Third Quarter 2023 and Recent Highlights

Full results from AURORA 2 (the long-term extension study of the Phase 3 AURORA trial) were published in Arthritis & Rheumatology, the official peer-reviewed journal of the American College of Rheumatology, demonstrating kidney preservation over the 3-year study period as measured by eGFR (estimated glomerular filtration rate) along with additional efficacy, safety, and tolerability of LUPKYNIS over the study duration.
A total of 14 LUPKYNIS clinical abstracts were accepted for presentation at the upcoming American Society of Nephrology and the American College of Rheumatology being held in November 2023. Led by several leading experts in nephrology and rheumatology, these presentations reinforce the long-term safety and efficacy profile of LUPKYNIS for the treatment of adults with active lupus nephritis (LN), a serious complication of systemic lupus erythematosus (SLE). The robust set of data demonstrates Aurinia’s deep commitment to sustained research in autoimmune diseases, including lupus.
Received notification that the pricing and reimbursement milestone was secured. As a result, this triggered a $10 million milestone from Otsuka Pharmaceutical Co. Ltd (Otsuka). Additionally, LUPKYNIS received marketing acceptance in Scotland by the Scottish Medicines Consortium.
Appointed three new directors to the Board of Directors – Dr. Karen Smith, Jeffrey Bailey, and Dr. Robert Foster.
LUPKYNIS Product Performance Highlights

There were approximately 1,939 patients on LUPKYNIS therapy at September 30, 2023, compared with 1,354 at September 30, 2022, representing an increase of approximately 43% year over year.
Aurinia added 436 patient start forms (PSFs) during the three months ended September 30, 2023, compared to 374 during the three months ended September 30, 2022, representing an increase of approximately 17% over the same period last year.
Through the end of October 2023, the Company recorded approximately 1,510 PSFs since January 1, 2023.
Conversion rates remain consistent with approximately 90% of PSFs converted to patients on therapy.
Time to convert has improved to an all-time high with the large majority (64%) of patients on therapy by 20 days.
Adherence improved from 84% at September 30, 2022 to 87% at September 30, 2023.
Persistency at 12 months has maintained at 54%; and remained stable at further months on therapy: 48% at 15 months and 43% at 18 months.
Financial Results for the Three and Nine Months Ended September 30, 2023

Total net revenue was $54.5 million and $55.8 million for the three months ended September 30, 2023 and September 30, 2022, respectively. Total net revenue was $130.4 million and $105.6 million for the nine months ended September 30, 2023 and September 30, 2022, respectively.

Net product revenue was $40.8 million and $25.5 million for the three months ended September 30, 2023 and September 30, 2022, respectively. Net product revenue was $116.2 million and $75.1 million for the nine months ended September 30, 2023 and September 30, 2022, respectively. The increase for both periods is primarily due to an increase in product sales to our two main customers for LUPKYNIS, driven predominantly by further penetration of the LN market.

License, royalty and collaboration revenue was $13.7 million and $30.3 million for the three months ended September 30, 2023 and September 30, 2022, respectively. License, royalty and collaboration revenue was $14.2 million and $30.5 million for the nine months ended September 30, 2023 and September 30, 2022, respectively. The decrease for both periods is due to the recognition of a $30.0 million regulatory milestone from Otsuka following the EC marketing authorization of LUPKYNIS in September 2022 partially offset by the recognition of a $10.0 million pricing and reimbursement milestone as well as recognition of collaboration revenue from Otsuka in the quarter ended September 2023.

Total cost of sales and operating expenses were $70.8 million and $65.3 million for the three months ended September 30, 2023 and September 30, 2022, respectively. Total cost of sales and operating expenses were $192.4 million and $189.0 million for the nine months ended September 30, 2023 and September 30, 2022, respectively. Further breakdown of cost of sales and operating expense drivers and fluctuations are highlighted in the following paragraphs.

Cost of sales were $6.8 million and $2.4 million for the three months ended September 30, 2023 and September 30, 2022, respectively. The increase is primarily due to increased sales of LUPKYNIS, coupled with the amortization of the monoplant finance right of use asset, which was placed into service in late June 2023.

Cost of sales were $8.8 million and $4.3 million for the nine months ended September 30, 2023 and September 30, 2022, respectively. The increase is primarily due to increased sales of LUPKYNIS coupled with the amortization of the monoplant finance right of use asset, partially offset by higher inventory reserves in 2022 due to the write-down of FDA validation batches.

Gross margin for the three months ended September 30, 2023 and September 30, 2022 was approximately 88% and 96%, respectively. Gross margin for the nine months ended September 30, 2023 and September 30, 2022 was approximately 93% and 96% respectively.

Selling, general and administrative (SG&A) expenses, inclusive of share-based compensation, were $47.8 million and $52.2 million for the three months ended September 30, 2023 and September 30, 2022, respectively. The decrease is primarily due to a decrease in professional fees and services (including legal fees with respect to litigation matters that occurred during the three months ended September 30, 2022), partially offset by an increase in share-based compensation expense.

SG&A expenses, inclusive of share-based compensation, were $145.0 million and $148.9 million for the nine months ended September 30, 2023 and September 30, 2022, respectively. The decrease was primarily due to a decrease in professional fees and services (including legal fees) and other corporate costs (including rent and insurance), partially offset by an increase in share-based compensation expense.

Non-cash SG&A share-based compensation expense included within SG&A expenses was $9.6 million and $6.6 million for the three months ended September 30, 2023 and September 30, 2022, respectively. Non-cash SG&A share-based compensation expense included within SG&A expenses, was $27.0 million and $21.5 million for the nine months ended September 30, 2023 and September 30, 2022, respectively.

Research and development (R&D) expenses, inclusive of share-based compensation, were $13.6 million and $11.0 million for the three months ended September 30, 2023 and September 30, 2022, respectively. The primary drivers for the increase were due to an increase in CRO and developmental costs as the Company advances its preclinical assets.

R&D expenses, inclusive of share-based compensation expense, were $39.4 million and $35.1 million for the nine months ended September 30, 2023 and September 30, 2022, respectively. The increase was primarily due to an increase in costs to advance the Company’s preclinical assets coupled with an increase in share-based compensation expense partially offset by the decrease in costs associated with the completion of the AURORA 2 continuation study and drug interaction study, which were substantially completed in 2022.

Non-cash R&D share-based compensation expense included with R&D expense was $2.0 million and $1.5 million for the three months ended September 30, 2023 and September 30, 2022, respectively. Non-cash R&D share-based compensation expense included with R&D expenses was $5.7 million and $3.5 million for the nine months ended September 30, 2023 and September 30, 2022, respectively.

Other (income) expense, net was $2.6 million and $(0.3) million for the three months ended September 30, 2023 and September 30, 2022, respectively. The change is primarily related to expenses incurred for shareholder matters partially offset by foreign exchange gain related to the revaluation of the monoplant finance lease liability.

Other (income) expense, net was $(0.7) million and $0.6 million for the nine months ended September 30, 2023 and September 30, 2022, respectively. The change is primarily related to change in fair value assumptions driven predominantly by rising interest rates related to our deferred compensation liability and foreign exchange gain on revaluation of the monoplant finance lease liability, partially offset by expenses incurred for shareholder matters.

Interest income was $4.5 million and $1.5 million for the three months ended September 30, 2023 and September 30, 2022, respectively. Interest income was $12.4 million and $2.2 million for the nine months ended September 30, 2023 and September 30, 2022, respectively. The increase for both periods is due to higher yields on our investments as a result of increased interest rates.

For the three months ended September 30, 2023, Aurinia recorded a net loss of $13.4 million or $0.09 net loss per common share, as compared to a net loss of $9.0 million or $0.06 net loss per common share for the three months ended September 30, 2022. For the nine months ended September 30, 2023, Aurinia recorded a net loss of $51.1 million or $0.36 net loss per common share, as compared to a net loss of $82.1 million or $0.58 net loss per common share for the nine months ended September 30, 2022.

Financial Liquidity at September 30, 2023

As of September 30, 2023, Aurinia had cash, cash equivalents and restricted cash and investments of $338.5 million compared to $389.4 million at December 31, 2022. The decrease is primarily related to the continued investment in commercialization activities and post approval commitments of our approved drug, LUPKYNIS, inventory purchases, advancement of our pipeline and monoplant payments, 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, such as 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, 2023 in the Company’s Quarterly Report on Form 10-Q and the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, including risk factors disclosed therein, which will be accessible on Aurinia’s website at www.auriniapharma.com, on SEDAR at www.sedarplus.ca 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, 2023 financial results today, Thursday, November 2, 2023 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 the corrected call-in number for participants +1 (877) 407-9170 / + 1 201-493-6756 (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.

Arvinas to Participate in Upcoming Investor Conferences

On November 2, 2023 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, reported that management will participate in five upcoming investor conferences (Press release, Arvinas, NOV 2, 2023, View Source [SID1234636732]):

Truist Securities BioPharma Symposium on Wednesday, November 8.
Sean Cassidy, chief financial officer, and Ron Peck, M.D., chief medical officer will be available to participate in one-on-one meetings.

Stifel Healthcare Conference on Tuesday, November 14.
John Houston, Ph.D., chairperson, chief executive officer, and president, and Ron Peck, M.D., chief medical officer, will be available to participate in one-on-one meetings and will participate in a fireside chat. A live audio webcast of the presentation will be on the Events + Presentations section of the Company’s website.

Jefferies London Healthcare Conference on Thursday, November 16.
John Houston, Ph.D., chairperson, chief executive officer, and president, and Sean Cassidy, chief financial officer will be available to participate in one-on-one meetings.

Piper Sandler 35th Annual Healthcare Conference on Tuesday, November 28.
Ian Taylor, Ph.D., chief scientific officer, and Randy Teel, Ph.D., senior vice president, corporate and business development, will be available to participate in one-on-one meetings and will participate in a fireside chat. A live audio webcast of the presentation will be on the Events + Presentations section of the Company’s website.

6th Annual Evercore ISI HealthCONx Conference on Thursday, November 30.

Ron Peck, M.D., chief medical officer and Jeff Boyle, vice president, investor relations, will be available to participate in one-on-one meetings and will participate in a fireside chat. A live audio webcast of the presentation will be on the Events + Presentations section of the Company’s website.

Arcellx Announces Oral Presentation for Its CART-ddBCMA Phase 1 Trial in Patients with Relapsed or Refractory Multiple Myeloma at the 65th ASH Annual Meeting and Exposition

On November 2, 2023 Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, reported that new clinical data from its Phase 1 study of CART-ddBCMA in patients with relapsed or refractory multiple myeloma will be presented at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition taking place December 9-12, 2023 in San Diego, California (Press release, Arcellx, NOV 2, 2023, View Source [SID1234636731]). The data in the ASH (Free ASH Whitepaper) abstract published today is from a June 2, 2023 data cut. The oral presentation at ASH (Free ASH Whitepaper) will be on Monday, December 11, 2023, at 5 p.m. PT and will include new data with a median follow-up of 26.5 months. The company will also have a medical affairs booth (#748) in Hall E of the San Diego Convention Center.

As detailed in the abstract (#1023), 38 patients were evaluable for efficacy and safety analysis as of the June 2, 2023 cutoff date, based on a median follow-up of 22 months following treatment. These evaluable patients comprised the dose escalation cohorts for the first dose level (100 (+/- 20) million CAR+ T cells, n=6) and the second dose level (300 (+/- 20) million CAR+ T cells, n=6), and a dose expansion cohort at 100 (+/- 20) million CAR+ T cells (n=26). The median dose administered to patients in the first dose level and dose expansion cohorts was 115 million CAR+ T cells. All patients evaluable for this analysis have poor prognostic factors with 38 of 38 (100%) patients triple-refractory, 26 of 38 (68%) penta-refractory, and 34 of 38 (89%) refractory to last-line of treatment by International Myeloma Working Group (IMWG) criteria. Additionally, 9 of 38 patients (24%) patients had high tumor burden with >60% bone marrow plasma (BMPC) cells, 13 of 38 patients (34%) patients had extramedullary disease (EMD), and 11 of 38 (29%) patients had high-risk cytogenetics (Del 17p, t(14;16), t(4;14)) at baseline. At baseline, 24 of 38 (63%) had at least one high risk clinical feature, defined as presence of EMD, BMPC >60% or B2M >5.5. All 38 patients had at least three prior lines of therapy.

The interim CART-ddBCMA Phase 1 clinical results (June 2, 2023 cutoff date) demonstrate deep and durable responses in patients with poor prognostic factors.

All Patients:

Of the 38 evaluable patients with a median follow-up of 22 months

•
100% overall response rate (ORR) achieved in all patients per IMWG criteria

•
29 of 38 evaluable patients achieved a complete response (CR) or a stringent complete response (sCR) (> CR rate, 76%)

•
35 patients achieved a very good partial response or higher (>VGPR rate, 92%)

Median duration of response, progression free survival (PFS), and overall survival were not reached at the time of the June 2, 2023 data cut because 25 of 38 (66%) evaluable patients had ongoing responses.

The Kaplan-Meier method estimated PFS rates for 6, 12, and 18 months were 92%, 74%, and 67% respectively. Durable responses were also observed in patients with high-risk features (EMD, BMPC ≥ 60%, or B2M ≥ 5.5 mg/L at baseline) and high-risk cytogenetics.

PFS rates at 6-, 12-, and 18 months by Kaplan-Meier method were:

PFS Rates (%)
6-month 12-month 18-month
All dosed (n=38)

92.1 74.3 67.5
Age ≥65 years (n=20)

95.0 84.4 78.4
Complete responders (n=29)

96.4 88.8 84.6
High Risk Features* (n=24)

91.7 73.3 68.1
Extramedullary Disease (n=13)

92.3 64.6 64.6
High Risk Cytogenetics (n=11)

81.8 70.1 70.1

*
High risk features defined as presence of EMD, BMPC ≥ 60, or B2M ≥5.5 mg/L. Note: increased from prior presentation from 22 to 24 subjects as a result of database update based on monitoring and query resolution.

CART-ddBCMA dosed at RP2D (115 million (+/- 10) CAR+ T cells) continues to be well-tolerated at the time of the data cut:

•
Adverse events with CART-ddBCMA, including CRS and ICANS, were manageable

•
No tissue-targeted toxicities were observed

•
No cases of delayed neurotoxicity events or parkinsonian symptoms were observed

ASH Presentation Details:

Title: Phase 1 Study of CART-ddBCMA for the Treatment of Patients with Relapsed and/or Refractory Multiple Myeloma: Results from at Least 1-Year Follow-up in All Patients

Speaker: Matthew J. Frigault, M.D., Clinical Director of the Cellular Therapy Service at Massachusetts General Cancer Center, and Assistant Professor at Harvard Medical School

Session Name: 704. Cellular Immunotherapies: Early Phase and Investigational Therapies: CAR-T Cell Therapies for Multiple Myeloma and B Cell Lymphomas

Session Date: Monday, December 11, 2023

Session Time: 4:30 – 6:00 p.m. PT (CART-ddBCMA oral presentation will be at 5 p.m. PT)

Location: San Diego Convention Center, Room 6A, San Diego, California

Publication Number: 1023

Webcast Event:

Arcellx will host a live webcast event with an expert panel of clinicians to discuss the clinical results on Monday, December 11, 2023 at 8 p.m. PT. The event will be accessible from Arcellx’s website at www.arcellx.com in the Investors section. A replay of the webcast will be archived and available for 30 days following the event.

About Multiple Myeloma

Multiple Myeloma (MM) is a type of hematological cancer in which diseased plasma cells proliferate and accumulate in the bone marrow, crowding out healthy blood cells and causing bone lesions, loss of bone density, and bone fractures. These abnormal plasma cells also produce excessive quantities of an abnormal immunoglobulin fragment, called a myeloma protein (M protein), causing kidney damage and impairing the patient’s immune function. Multiple myeloma is the third most common hematological malignancy in the United States and Europe, representing approximately 10% of all hematological cancer cases and 20% of deaths due to hematological malignancies. The median age of patients at diagnosis is 69 years with one-third of patients diagnosed at an age of at least 75 years. Because MM tends to afflict patients at an advanced stage of life, patients often have multiple co-morbidities and toxicities that can quickly escalate and become life-endangering.

About CART-ddBCMA

CART-ddBCMA is Arcellx’s BCMA-specific CAR-modified T-cell therapy utilizing the company’s novel BCMA-targeting binding domain for the treatment of patients with relapsed or refractory multiple myeloma. CART-ddBCMA is currently in a Phase 2 study. Arcellx’s proprietary binding domains are novel synthetic proteins designed to bind specific therapeutic targets. CART-ddBCMA has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy Designations by the U.S. Food and Drug Administration.

Aptose Tuspetinib Clinical Data Selected for Oral Presentation at the 2023 ASH Annual Meeting

On November 2, 2023 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company developing highly differentiated targeted agents to treat hematologic malignancies, reported that clinical data for tuspetinib, a once daily oral therapy, has been selected for oral presentation at the 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition being held December 9-12, 2023, in San Diego, CA (Press release, Aptose Biosciences, NOV 2, 2023, View Source [SID1234636730]).

Lead investigator Naval Daver, MD, Professor, Director Leukemia Research Alliance Program, Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, will present data from Aptose’s ongoing APTIVATE trial of tuspetinib in relapsed/refractory patients with acute myeloid leukemia.

The abstract accepted for presentation is listed below and can be viewed online at the ASH (Free ASH Whitepaper) conference website. Note that the actual presentation will include more recent updates and additional data not found in the abstract.

Oral Presentation Details

Title: Tuspetinib Myeloid Kinase Inhibitor Safety and Efficacy As Monotherapy and Combined with Venetoclax in Phase 1/2 Trial of Patients with Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML)
Publication Number: 162
Oral Presentation Session Date & Time: Saturday, December 9, 2023, 3:15 PM PT
Session Name: 616. Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies: Novel Uses of Approved Therapeutic Agents
Location: San Diego Convention Center, Room 6A

Anaptys Announces Third Quarter 2023 Financial Results and Provides Business Update

On November 2, 2023 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, reported operating results for the third quarter ended September 30, 2023 and provided a business update (Press release, AnaptysBio, NOV 2, 2023, View Source [SID1234636729]).

"We’ve made strong progress this quarter executing against our multi-year plan to develop best-in-class immune cell modulators to drive differentiated clinical outcomes in heterogeneous, systemic autoimmune and inflammatory diseases," said Daniel Faga, president and chief executive officer of Anaptys. "Enrollment is ongoing in our global Phase 2b trials in atopic dermatitis for ANB032, our BTLA agonist, and rheumatoid arthritis for rosnilimab, our PD-1 agonist, while also initiating a global Phase 2 trial in ulcerative colitis for rosnilimab in Q4 2023."

Updates on Wholly Owned Immune Cell Modulator Pipeline

Rosnilimab (PD-1 agonist antibody)

Initiated in August a global Phase 2b trial in moderate-to-severe RA
420-patient placebo-controlled trial assessing three dose levels of subcutaneously administered rosnilimab (randomized 1:1:1:1) for a 12-week treatment duration on well-established endpoints, including DAS28-CRP, CDAI and ACR20/50/70
At Week 14, rosnilimab-treated patients who achieve low disease activity, defined as CDAI<=10, are eligible to be dosed for an additional 16-week all-active treatment period and then followed for a three-month off-drug follow-up period
Top-line Week 12 data anticipated by mid 2025
Anticipate initiation in Q4 2023 of a global Phase 2 trial in moderate-to-severe UC
130-patient placebo-controlled trial assessing two dose levels of subcutaneously administered rosnilimab (randomized 1:1:1) for a 12-week treatment duration on well-established endpoints, including clinical response on modified Mayo score (mMS), clinical remission on mMS and endoscopic remission
Rosnilimab and placebo-treated patients who achieved clinical response on mMS are eligible to continue on their assigned treatment for an additional 12 weeks, while patients on placebo who are non-responders will be crossed over to the high-dose rosnilimab treatment arm, in an all-active treatment period and then followed for a three-month off-drug follow-up period
Top-line Week 12 data anticipated by H1 2026
Hosted a virtual PD-1 Agonist (Rosnilimab) R&D Event in October 2023
Replay of the audio webcast is available here
Announcing two poster presentations at American College of Rheumatology (ACR) Convergence 2023 in San Diego, Nov. 10-15, 2023. Full preliminary program is available online on the ACR website –
Optimizing PD-1 Agonist Signaling with Membrane Proximal Binding of Rosnilimab, a Clinical Stage PD-1 Agonist IgG1 Antibody (abstract #0086)
Rosnilimab, a Novel PD-1 Agonist Monoclonal Antibody, Inhibits Peripheral T Cell Proliferation and Cytokine Secretion and Reduces Circulating PD-1 High Expressing T Cells: Results from a Phase 1 Healthy Volunteer Clinical Trial (abstract #0455)

ANB032 (BTLA agonist antibody)

Enrollment ongoing for global Phase 2b trial in moderate-to-severe atopic dermatitis (AD)
160-patient placebo-controlled trial assessing three dose levels of subcutaneously administered ANB032 (randomized 1:1:1:1) for a 14-week treatment duration and then followed for a six-month off-drug follow-up period on well-established endpoints, including EASI75 and IGA 0/1
Top-line Week 14 data anticipated by year-end 2024
Presented poster on ANB032’s previously reported healthy volunteer Phase 1 data and a trial-in-progress poster presentation on ANB032’s Phase 2b study in moderate-to-severe AD at the 32 European Academy of Dermatology and Venerology (EADV) Congress in October 2023
Poster presentations are available here

ANB033 (anti-CD122 antagonist antibody)

Plan to submit an Investigational New Drug (IND) application in H1 2024

Updates on Legacy Clinical-Stage Cytokine Antagonist Programs Available for Out-Licensing

Announced positive top-line Phase 3 clinical trial results of imsidolimab (IL-36R) in generalized pustular psoriasis (GPP)
53.3% of patients who received a single dose of 750mg IV imsidolimab achieved GPPPGA 0/1 (clear or almost clear) at Week 4 (primary endpoint), compared to 13.3% of patients on placebo (p=0.0131)
Demonstrated favorable safety and tolerability with no SAEs, low incidence and no increase of infections vs. placebo and no cases of DRESS or Guillain-Barre in imsidolimab-treated patients
Only one of 30 (3.3%) imsidolimab-treated patients had detectable ADA, which were non-neutralizing
Intend to out-license imsidolimab in 2024

Updates on GSK Immuno-Oncology Financial Collaboration

GSK anticipates top-line data in H2 2024 from COSTAR Lung Phase 3 trial comparing cobolimab, a TIM-3 antagonist, plus dostarlimab, a PD-1 antagonist, plus docetaxel to dostarlimab plus docetaxel to docetaxel alone in patients with advanced NSCLC who have progressed on prior anti-PD-(L)1 therapy and chemotherapy
GSK anticipates top-line data in H1 2024 from the FIRST Phase 3 trial for platinum-based therapy with dostarlimab and niraparib versus platinum-based therapy as first-line treatment of Stage III or IV nonmucinous epithelial ovarian cancer
Anaptys has regained full global rights to GSK4074386, a Phase 2 ready LAG-3 antagonist antibody, from GSK

Year-End Cash Guidance

Reiterating cash runway through year-end 2026 with updated expected year-end 2023 cash and investments of $400 to $410 million

Third Quarter Financial Results

Cash, cash equivalents and investments totaled $453.3 million as of September 30, 2023, compared to $584.2 million as of December 31, 2022, for a decrease of $130.9 million. The decrease relates to cash used for the $50 million stock repurchase program and operating activities.
Collaboration revenue was $3.3 million and $8.2 million for the three and nine months ended September 30, 2023, compared to $1.3 million and $3.5 million for the three and nine months ended September 30, 2022. The change is due primarily to increased royalties recognized for sales of Jemperli.
Research and development expenses were $30.9 million and $98.8 million for the three and nine months ended September 30, 2023, compared to $22.1 million and $65.4 million for the three and nine months ended September 30, 2022. The increase was due primarily to manufacturing and development costs for rosnilimab, ANB032 and ANB033. The R&D non-cash, stock-based compensation expense was $2.2 million and $7.7 million for the three and nine months ended September 30, 2023 as compared to $1.5 million and $5.0 million in the same period in 2022.
General and administrative expenses were $10.2 million and $31.7 million for the three and nine months ended September 30, 2023, compared to $8.9 million and $27.2 million for the three and nine months ended September 30, 2022. The G&A non-cash, stock-based compensation expense was $5.6 million and $17.4 million for the three and nine months ended September 30, 2023 as compared to $4.7 million and $15.7 million in the same period in 2022.
Net loss was $37.3 million and $121.4 million for the three and nine months ended September 30, 2023, or a net loss per share of $1.41 and $4.49, compared to a net loss of $33.5 million and $102.3 million for the three and nine months ended September 30, 2022, or a net loss per share of $1.18 and $3.64.