Cingal (hyaluronic acid/triamcinolone) / Anika Therap - LARVOL DELTA

Effectiveness of Cingal™ for Improving Pain Scores and Function in Anterior Knee Pain (clinicaltrials.gov) - P=N/A | N=24 | Not yet recruiting | Sponsor: Banff Sport Medicine Foundation | Trial completion date: Nov 2024 ➔ Nov 2026 | Trial primary completion date: Apr 2024 ➔ Apr 2026

Trial completion date • Trial primary completion date • Musculoskeletal Pain • Pain

Intra-articular Injection of a Cross-Linked Hyaluronic Acid Combined with Triamcinolone Hexacetonide Improves Pain at 6 Months in Patients with Mild to Moderate Hip Osteoarthritis: A Prospective Observational Study. (PubMed, J ISAKOS) - "Patients receiving an ultrasound-guided Cingal™ injection for hip OA reported statistically significantly reduced hip pain, improved function and quality of life, and reduced pain medication use at six months. The most common adverse event was transient hip pain."

Journal • Observational data • Immunology • Orthopedics • Osteoarthritis • Pain • Rheumatology

Anika Reports First Quarter 2024 Financial Results (GlobeNewswire) - "Extended exclusive distribution agreement with our established Canadian commercial partner, Pendopharm, to sell Cingal, Monovisc and Orthovisc through 2030, building on the existing market leadership position in Canada."

Licensing / partnership • CNS Disorders • Osteoarthritis • Pain

Study of Cingal® for Symptomatic Relief of Osteoarthritis of Hip Joint (clinicaltrials.gov) - P=N/A | N=25 | Completed | Sponsor: Anika Therapeutics, Inc. | Phase classification: P3 ➔ P=N/A

Phase classification • Immunology • Osteoarthritis • Pain • Rheumatology

Study of Cingal® for Symptomatic Relief of Osteoarthritis of Shoulder Joint (clinicaltrials.gov) - P=N/A | N=25 | Completed | Sponsor: Anika Therapeutics, Inc. | Phase classification: P3 ➔ P=N/A

Phase classification • Immunology • Osteoarthritis • Pain • Rheumatology

Study of Cingal® for Symptomatic Relief of Osteoarthritis of Ankle Joint (clinicaltrials.gov) - P=N/A | N=25 | Completed | Sponsor: Anika Therapeutics, Inc. | Phase classification: P3 ➔ P=N/A

Phase classification • Immunology • Osteoarthritis • Pain • Rheumatology

Comparison of the Analgesic Effect of 2 Shoulder Infiltrations (clinicaltrials.gov) - P=N/A | N=84 | Recruiting | Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Osteoarthritis • Pain • Rheumatology

ECHO: A Prospective Evaluation of the Cingal Injection for Hip Osteoarthritis (clinicaltrials.gov) - P=N/A | N=100 | Completed | Sponsor: McMaster University | Active, not recruiting ➔ Completed

Trial completion • Immunology • Osteoarthritis • Pain • Rheumatology

Anika Reports First Quarter 2023 Financial Results (GlobeNewswire) - "Advancing Cingal^® Towards U.S. Regulatory Approval: Actively engaging with the FDA regarding next steps for U.S. regulatory approval and exploring commercial partnerships in the U.S. and select Asian markets."

FDA event • CNS Disorders • Osteoarthritis • Pain

ECHO: A Prospective Evaluation of the Cingal Injection for Hip Osteoarthritis (clinicaltrials.gov) - P=N/A | N=100 | Active, not recruiting | Sponsor: McMaster University | Trial primary completion date: Jan 2023 ➔ Jul 2023

Trial primary completion date • Immunology • Osteoarthritis • Pain • Rheumatology

Effectiveness of Cingal™ for Improving Pain Scores and Function in Anterior Knee Pain (clinicaltrials.gov) - P=N/A | N=24 | Not yet recruiting | Sponsor: Banff Sport Medicine Foundation

New trial • Musculoskeletal Pain • Pain

Study of Cingal® and Triamcinolone Hexacetonide for the Relief of Knee Osteoarthritis Pain (clinicaltrials.gov) - P3 | N=231 | Completed | Sponsor: Anika Therapeutics, Inc. | Active, not recruiting ➔ Completed

Trial completion • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

ECHO: A Prospective Evaluation of the Cingal Injection for Hip Osteoarthritis (clinicaltrials.gov) - P=N/A | N=100 | Active, not recruiting | Sponsor: McMaster University | Recruiting ➔ Active, not recruiting

Enrollment closed • Immunology • Osteoarthritis • Pain • Rheumatology

Anika’s Cingal Successfully Achieves Primary Endpoint in Third Phase III Study (GlobeNewswire) - P3 | N=231 | NCT04231318 | Sponsor: Anika Therapeutics, Inc.| "Anika Therapeutics, Inc...today announced that Cingal® met its primary endpoint in a Phase III Study (Cingal 19-01), demonstrating superiority over triamcinolone hexacetonide (TH) steroid alone at 26 weeks post-treatment. The Cingal 19-01 Phase III study is the third completed Phase III study of Cingal and, together with previous studies, has now demonstrated superiority over each of its active ingredients and placebo. Across the three completed Phase III studies, Cingal demonstrated a mean 71% pain improvement from baseline and a mean 91% of Cingal subjects were deemed to be Responders....Anika will engage with the U.S. Food and Drug Administration (FDA) in the coming months on next steps for U.S. regulatory approval. In parallel, Anika is exploring the potential to advance Cingal through commercial partnerships in the U.S. and select Asian markets..."

FDA event • Licensing / partnership • P3 data • CNS Disorders • Osteoarthritis • Pain

Anika Therapeutics : Reports Second Quarter Fiscal 2022 Financial Results - Form 8-K (Market Screener) - "Completed last patient follow-up in the Cingal® pilot study in June, with data readout expected in Fall 2022."

Clinical data • CNS Disorders • Osteoarthritis • Pain

Comparison of the Analgesic Effect of 2 Shoulder Infiltrations (clinicaltrials.gov) - P=N/A | N=84 | Not yet recruiting | Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

New trial • Immunology • Osteoarthritis • Pain • Rheumatology

ECHO: A Prospective Evaluation of the Cingal Injection for Hip Osteoarthritis (clinicaltrials.gov) - P=N/A | N=100 | Recruiting | Sponsor: McMaster University | Trial completion date: Sep 2022 ➔ Sep 2023 | Trial primary completion date: Jan 2022 ➔ Jan 2023

Trial completion date • Trial primary completion date • Immunology • Osteoarthritis • Pain • Rheumatology

Anika Reports Fourth Quarter and Year-End 2021 Financial Results (GlobeNewswire) - "Anika Therapeutics, Inc...today reported financial results for its fourth quarter and full year ended December 31, 2021....Completed enrollment in Q4 2021 of the U.S. pilot clinical trial of Cingal, Anika’s combination viscosupplement / steroid product for OA pain management."

Enrollment closed • CNS Disorders • Osteoarthritis • Pain

Study of Cingal® for Symptomatic Relief of Osteoarthritis of Hip Joint (clinicaltrials.gov) - P3 | N=25 | Completed | Sponsor: Anika Therapeutics, Inc. | Recruiting ➔ Completed | Trial completion date: Feb 2022 ➔ Sep 2021 | Trial primary completion date: Feb 2022 ➔ Sep 2021

Trial completion • Trial completion date • Trial primary completion date • Immunology • Osteoarthritis • Pain • Rheumatology

Study of Cingal® for Symptomatic Relief of Osteoarthritis of Shoulder Joint (clinicaltrials.gov) - P3 | N=25 | Completed | Sponsor: Anika Therapeutics, Inc. | Recruiting ➔ Completed | Trial completion date: Feb 2022 ➔ Sep 2021 | Trial primary completion date: Feb 2022 ➔ Sep 2021

Trial completion • Trial completion date • Trial primary completion date • Immunology • Osteoarthritis • Pain • Rheumatology

Study of Cingal® for Symptomatic Relief of Osteoarthritis of Ankle Joint (clinicaltrials.gov) - P3 | N=25 | Completed | Sponsor: Anika Therapeutics, Inc. | Recruiting ➔ Completed | Trial completion date: Feb 2022 ➔ Sep 2021 | Trial primary completion date: Feb 2022 ➔ Sep 2021

Trial completion • Trial completion date • Trial primary completion date • Immunology • Osteoarthritis • Pain • Rheumatology

Study of Cingal® and Triamcinolone Hexacetonide for the Relief of Knee Osteoarthritis Pain (clinicaltrials.gov) - P3; N=231; Active, not recruiting; Sponsor: Anika Therapeutics, Inc.; Recruiting ➔ Active, not recruiting; Trial completion date: Nov 2021 ➔ May 2022; Trial primary completion date: Nov 2021 ➔ May 2022

Clinical • Enrollment closed • Trial completion date • Trial primary completion date • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

Anika Therapeutics, inc (ANIK) Q3 2021 Earnings Call Transcript (The Motley Fool) - "Clinical study enrollment for both our single-stage cartilage repair product, HYALOFAST and our second-generation OA pain solution, CINGAL, continues. Despite clinical trial enrollment challenges related to COVID, I am very pleased to report that enrollment in the CINGAL pilot is on track to be completed in November....Also through 2024, we'll continue to invest in HYALOFAST and CINGAL, with ongoing clinical development to bring them to the market in the United States..."

Commercial • Enrollment status • CNS Disorders • Osteoarthritis • Pain

Study of Cingal® and Triamcinolone Hexacetonide for the Relief of Knee Osteoarthritis Pain (clinicaltrials.gov) - P3; N=231; Recruiting; Sponsor: Anika Therapeutics, Inc.; Phase classification: P2 ➔ P3

Clinical • Phase classification • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

ECHO: A Prospective Evaluation of the Cingal Injection for Hip Osteoarthritis (clinicaltrials.gov) - P=N/A; N=100; Recruiting; Sponsor: McMaster University; Not yet recruiting ➔ Recruiting; Trial primary completion date: Sep 2021 ➔ Jan 2022

Clinical • Enrollment open • Trial primary completion date • Immunology • Osteoarthritis • Pain • Rheumatology