On August 3, 2021 Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) ("Kiniksa"), a biopharmaceutical company with a portfolio of assets designed to modulate immunological pathways across a spectrum of diseases, reported second quarter 2021 financial results and recent corporate and portfolio activity (Press release, Kiniksa Pharmaceuticals, AUG 3, 2021, View Source [SID1234585593]).

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"Our commercial team is doing a superb job with the launch of ARCALYST in recurrent pericarditis," said Sanj K. Patel, Chief Executive Officer and Chairman of the Board of Kiniksa. "Feedback received from physicians and patients highlights the transformational potential of ARCALYST for patients suffering from recurrent pericarditis. We have seen strong uptake and look forward to using this momentum to accelerate broader adoption across this underserved population."

"We are executing on the development of our clinical-stage pipeline," said John F. Paolini, MD, PhD, Chief Medical Officer of Kiniksa. "The potential broad utility of mavrilimumab across multiple indications is increasingly promising, and we expect data from our Phase 3 clinical trial in COVID-19-related ARDS in the first quarter of 2022. We are enrolling a Phase 2b clinical trial of vixarelimab in prurigo nodularis and believe vixarelimab has the potential to make a meaningful impact on these patients’ lives by addressing both the pruritus and the skin nodules associated with this devastating disease. KPL-404, our anti-CD40 program, has potential across a range of autoimmune diseases, and we plan to initiate a Phase 2 proof-of-concept clinical trial in rheumatoid arthritis in the fourth quarter of this year."

Portfolio Activity
ARCALYST (IL-1α and IL-1β cytokine trap)

ARCALYST net revenue in the second quarter of 2021 was $7.7 million.
The second quarter of 2021 represented Kiniksa’s first quarter of ARCALYST sales. ARCALYST became commercially available through Kiniksa on April 1st, 2021.
Greater than 100 physicians who did not participate in Phase 3 RHAPSODY prescribed ARCALYST to at least one recurrent pericarditis patient.
Greater than 65% of all recurrent pericarditis enrollments came from physicians practicing outside of the 12 Phase 3 RHAPSODY clinical trial sites in the U.S.
Greater than 90% of completed new patient enrollment cases were approved for coverage under the payer medical exceptions process.
Kiniksa continues to expect that the majority of payers will establish coverage policies within six months and that almost all payers will update their coverage policies within a year from launch.
Kiniksa OneConnectTM provided access, initiation and ongoing support for existing ARCALYST cryopyrin-associated periodic syndromes (CAPS) and deficiency of IL-1 receptor antagonist (DIRA) patients transitioning to Kiniksa product as well as new ARCALYST patients for all approved indications.
Mavrilimumab (monoclonal antibody inhibitor targeting GM-CSFRα)

Kiniksa’s interactions with the U.S. Food and Drug Administration (FDA) resulted in defined paths for Phase 3 development of mavrilimumab in COVID-19-related acute respiratory distress syndrome (ARDS) and in giant cell arteritis (GCA).
Kiniksa reported additional data from the Phase 2 portion of the Phase 2/3 clinical trial of mavrilimumab in patients with severe COVID-19-related ARDS.
Follow-up overall survival data from the cohort of non-mechanically ventilated patients through Day 90 demonstrated persistent clinical effect, confirming and extending the previously-reported Day 29 data.
Day 29 data from the cohort of mechanically-ventilated patients did not show a reduction in death.
Kiniksa continues to enroll non-mechanically ventilated patients in the Phase 3 clinical trial of mavrilimumab in COVID-19-related ARDS.
Kiniksa discontinued enrolling mechanically-ventilated patients in the Phase 3 trial.
Kiniksa expects data from the Phase 3 trial in non-mechanically-ventilated patients in the first quarter of 2022.
Vixarelimab (monoclonal antibody inhibitor of signaling through OSMRβ)

Kiniksa continues to enroll patients in a placebo-controlled Phase 2b clinical trial of vixarelimab in prurigo nodularis, evaluating a range of once-monthly dose regimens via subcutaneous (SC) injection.
The primary efficacy endpoint is the percent change from baseline in the weekly-average Worst-Itch Numeric Rating Scale at Week 16.
KPL-404 (monoclonal antibody inhibitor of the CD40 and CD154 interaction)

Kiniksa plans to initiate a placebo-controlled Phase 2 proof-of-concept clinical trial of KPL-404 in rheumatoid arthritis in the fourth quarter of 2021.
The planned trial is designed to provide safety data, pharmacokinetic characterization, and efficacy of chronic SC dosing over 12 weeks.
Rheumatoid arthritis was selected for demonstration of KPL-404 proof of concept as it is a well-characterized autoimmune disease with decades of published clinical data across diverse mechanistic classes, allowing for objective evaluation in established endpoints.
The pharmacokinetic lead-in of the planned trial supports characterization of chronic administration of KPL-404 in a patient population and provides optionality to evaluate the therapeutic potential of KPL-404 across a range of other autoimmune diseases with pathologies believed to be mediated by the CD40-CD154 pathway.
Upcoming Scientific Conference Presentations

Kiniksa plans to present additional data from RHAPSODY, the pivotal Phase 3 trial of rilonacept, as well as the study design of the RESONANCE Registry, at the European Society of Cardiology virtual congress, which will be held August 27, 2021 through August 30, 2021. Details of the poster presentations are as follows:
Antonio Brucato, MD, Department of Biomedical and Clinical Science, University of Milan, Fatebenefratelli Hospital, Milan, will present a poster entitled, Health-Related Quality of Life in Patients with Recurrent Pericarditis: Results from RHAPSODY, a Phase 3 Study of Rilonacept.
Alison Reid, PhD, Kiniksa Pharmaceuticals Corp., will present a poster entitled, RESONANCE Registry: Rationale and Design of the Retrospective and Prospective Longitudinal, Observational Registry in Pediatric and Adult Patients with Recurrent Pericarditis.
Financial Results

Total revenue in the second quarter of 2021 was $7.7 million. Second quarter 2021 revenue is related to product sales for ARCALYST, which became commercially available through Kiniksa on April 1, 2021. Kiniksa did not generate product revenue in the second quarter of 2020.
Net loss for the second quarter of 2021 was $41.6 million, compared to a net loss of $37.5 million for the second quarter of 2020.
Total operating expenses for the second quarter of 2021 were $48.3 million, compared to $31.9 million for the second quarter of 2020.
Non-cash, share-based compensation expense for the second quarter of 2021 was $5.7 million, compared to $4.9 million for the second quarter of 2020.
As of June 30, 2021, the company had cash, cash equivalents and short-term investments of $225.9 million and no debt.
Financial Guidance

Kiniksa expects ARCALYST net revenue for the third quarter of 2021 to be between $9.0 million and $10.0 million.
Kiniksa expects that its cash, cash equivalents and short-term investments will fund its current operating plan into 2023.
Conference Call Information
Kiniksa will host a conference call and webcast at 8:30 a.m. Eastern Time on Tuesday, August 3, 2021 to discuss second quarter 2021 financial results and recent corporate and portfolio activity. Individuals interested in participating in the call should dial (866) 614-0636 (U.S. and Canada) or (409) 231-2053 (international) using conference ID number 1485623. To access the webcast, please visit the Investors and Media section of Kiniksa’s website at www.kiniksa.com. The archived webcast will be available on Kiniksa’s website for 14 days beginning approximately one hour after the call has completed.