Coherus Oncology, Inc. reports commercial-stage oncology developments centered on LOQTORZI® (toripalimab-tpzi), an approved next-generation PD-1 inhibitor for recurrent or metastatic nasopharyngeal carcinoma. Company updates also cover its antibody immunotherapy pipeline, including tagmokitug, an anti-CCR8 cytolytic antibody, and casdozokitug, an IL-27 antagonistic antibody, across solid-tumor programs such as liver, prostate, head and neck, colorectal, gastric and esophageal cancers.
Recurring news includes financial results, LOQTORZI revenue commentary, clinical-development updates, strategic partnerships, investor-conference presentations, public common-stock offerings, debt reduction and other capital-structure actions tied to the company's transition from biosimilars to innovative oncology.
Coherus BioSciences and Junshi Biosciences announced significant improvements in overall survival (OS) and progression-free survival (PFS) in their phase 3 trial of toripalimab combined with chemotherapy for treatment-naïve advanced non-small cell lung cancer (NSCLC) without EGFR/ALK mutations. The trial showed a median PFS of 8.4 months compared to 5.6 months for chemotherapy alone, and a 2-year OS rate of 51.2% versus 33.9%. No new safety concerns were reported. This data supports further development of toripalimab in combination with other immunotherapies.
CIMERLI is the first FDA-approved biosimilar interchangeable with Lucentis for all indications, with a 12-month exclusivity on interchangeability. Launching on October 3, 2022, it offers the same efficacy and safety as Lucentis, allowing for confident transitions for existing patients. The product is priced at $1,360 for the 0.5 mg dose, providing a 30% discount compared to Lucentis. Coherus aims to capture a significant market share by leveraging its dedicated sales team and CIMERLI Solutions™ for patient support and reimbursement.
Coherus BioSciences (Nasdaq: CHRS) announced participation in the H.C. Wainwright 24th Annual Global Investment Conference on September 14, 2022, at 10:00 am ET. Senior management will engage in a fireside chat, which will be available via an audio webcast on the company's investor page. Interested parties are encouraged to access the webcast in advance to ensure a timely connection. The archived webcast will be accessible on the Coherus website for 30 days following the event.
Coherus BioSciences (Nasdaq: CHRS) announced the grant of stock options for an aggregate of 234,000 shares to 22 new employees, effective August 24, 2022. The options have a per-share exercise price of $12.90, matching the closing trading price on the grant date. This action is part of the Company’s 2016 Employment Commencement Incentive Plan aimed at attracting new talent.
Coherus BioSciences (CHRS) reported a Q2 2022 net revenue of $60.2 million, down from $87.6 million in Q2 2021, mainly due to decreased sales of UDENYCA®. The FDA approved CIMERLI™ for commercial launch in October 2022 and set a PDUFA date of December 23, 2022, for toripalimab's BLA. The company has $275 million in cash and is preparing for the launch of several products, including YUSIMRY™. Net loss for Q2 2022 was $50.2 million, widening from a loss of $29.9 million in Q2 2021. R&D and SG&A expense guidance has been revised down to $375-$395 million.
Coherus BioSciences announced FDA approval for CIMERLI™ (ranibizumab-eqrn), an interchangeable biosimilar to Lucentis®, for all five FDA-approved indications, marking its third product approval. With expected sales starting in October 2022, CIMERLI™ aims to enhance treatment access in the $7 billion anti-VEGF ophthalmology market. The COLUMBUS AMD trial confirmed CIMERLI™'s clinical equivalence to Lucentis®, showing comparable safety and efficacy. Coherus plans additional product launches, including YUSIMRY™, a Humira® biosimilar, in 2023.
Coherus BioSciences (CHRS) announced the grant of stock options to two newly hired executives, effective August 1, 2022. A total of 250,000 options were awarded, with an exercise price of $9.16 per share, matching the closing price on the grant date. The Executive Vice President received 150,000 options, while the Senior Vice President was granted 100,000. This incentive is part of Coherus' 2016 Employment Commencement Incentive Plan, which aims to attract new talent and was approved by the board of directors in June 2016.
Coherus BioSciences (CHRS) will release its second quarter 2022 financial results after market close on August 4, 2022. The management will host a conference call at 5 p.m. ET to discuss these results and provide a business update. Investors can access the results on the Coherus website post-release. The call can be joined through specific dial-in numbers provided for both U.S. and international participants. Early connection is advised for attendees.
The FDA has accepted Coherus BioSciences’ Biologics License Application (BLA) for toripalimab, targeted for patients with advanced nasopharyngeal carcinoma (NPC). A decision is expected by December 23, 2022. Toripalimab aims to be the first approved immunotherapy for NPC in the U.S. and is crucial for patients facing unmet medical needs. The anticipated launch is set for Q1 2023, pending FDA approval. The drug is supported by positive Phase 2 and 3 clinical trial results, emphasizing its potential as a key oncology product for Coherus.
Coherus BioSciences, Inc. (CHRS) announced the granting of stock options to 16 new employees as of June 16, 2022. A total of 409,000 shares were made available, with a per-share exercise price of $5.86, the closing price on the grant date. The options include 200,000 shares for a Chief level executive and 45,000 shares for a Vice President, while 14 non-officer employees received a combined total of 164,000 shares. This initiative is part of the 2016 Employment Commencement Incentive Plan aimed at attracting new talent.