Adc Therapeutics Ltd (ADCT) News & EventsADCTAdc Therapeutics Ltd

ADC Therapeutics and Tanabe Pharma Apply for Zynlonta Marketing Authorization in Japan

ADC Therapeutics' Japanese licensing partner, Tanabe Pharma, filed a marketing authorization application with Japan's Ministry of Health, Labor and Welfare on October 29 for Zynlonta - loncastuximab tesirine-lpyl - to treat patients with relapsed or refractory diffuse large B-cell lymphoma, or DLBCL after two or more lines of systemic therapy. In addition, Tanabe Pharma has entered into an exclusive sublicensing agreement with Nippon Shinyaku for the commercialization of Zynlonta in Japan. Recently, "encouraging" results from the Phase 1/2 MT-2111-A-101 bridging study evaluating Zynlonta monotherapy in Japanese patients with relapsed or refractory DLBCL were presented at the Japanese Society of Hematology meeting. In the Phase 2 portion of the study in Japan, Zynlonta demonstrated an overall response rate of 58.1%, including a complete response rate of 41.9%, with median duration of response not reached at a median follow-up of 15.21 months. Based on these results, Tanabe Pharma filed the marketing authorization application for Zynlonta in Japan. Building on ADC Therapeutics' exclusive licensing partnership with Tanabe Pharma established in 2022, Nippon Shinyaku will bring its established hematology/oncology commercial expertise to support ZYNLONTA's potential introduction in Japan. Nippon Shinyaku has a strong commercial and field medical presence in Japan, with a track record of successfully introducing innovative therapies developed by global pharmaceutical companies to the Japanese market. Under the sublicensing agreement, Tanabe Pharma will remain responsible for ongoing development activities and for obtaining regulatory approval in Japan under the current application. Under the existing license agreement between ADC Therapeutics and Tanabe Pharma as previously disclosed, near-term milestones include acceptance of filing a marketing authorization application for ZYNLONTA in the Tanabe Pharma territory for the treatment of DLBCL and the first commercial sale of ZYNLONTA in the Tanabe Pharma territory for the treatment of DLBCL.

ADC Therapeutics Completes $86.6M Financial Restructuring

ADC Therapeutics announced a comprehensive strategic financial restructuring designed to strengthen its balance sheet, reduce leverage, increase strategic optionality and extend cash runway into 2029. The strategic initiative includes securing new equity financing, restructuring the HealthCare Royalty, or HCR, agreement, and reducing the outstanding loan principal. The company entered into securities purchase agreements for the sale of its equity securities to certain institutional investors in an $86.6M private investment in public equity, or PIPE, financing. In the PIPE, ADC Therapeutics is selling 12.9 million common shares at $1.42 per share and pre-funded warrants to purchase 48.1 million common shares at $1.32, per pre-funded warrant. Gross proceeds from the PIPE are anticipated to be approximately $86.6M. The PIPE is expected to close on October 22. ADC Therapeutics intends to use the net proceeds from the PIPE to invest in continued funding of Zynlonta pipeline studies and strengthen the balance sheet. The company also entered into an amendment to its purchase and sale agreement with certain entities managed by HCR which eliminates the $150M payment otherwise required solely upon a change of control , and reduces the aggregate outstanding principal amount of third-party indebtedness of the company, and its subsidiaries are permitted to incur to $50.0M. The company and certain subsidiaries, the lenders party and Blue Owl Opportunistic entered into a second loan agreement amendment which provides for the prepayment of $70.0M principal amount of term loans, plus accrued and unpaid interest. After such prepayment, the principal amount of outstanding term loans under the loan agreement will be $50.0M.

ZYNLONTA Q2 Revenue at $18.6M, Below Consensus

Reports Q2 revenue $18.6M, consensus $18.9M. "We are pleased by our Q2 performance, which reflects continued commercial momentum and strong operational discipline through ongoing cost reduction efforts. Over the course of this year, we have released LOTIS-5 data and completed the LOTIS-7 trial. With these data now in hand, we believe that ZYNLONTA plus glofitamab offers an opportunity to take a leading second-line plus position, in the context of the evolving competitive landscape, solidifying ZYNLONTA as a foundational therapy in DLBCL," said CEO Ameet Mallik. "Additionally, following the FDA pre-sBLA meeting for the LOTIS-5 trial, we are assessing regulatory approaches to determine the best path forward." "As we work to advance ZYNLONTA into earlier lines of DLBCL, we remain confident that ZYNLONTA will continue to play a meaningful role for patients with B-cell malignancies, in the 3L+ DLBCL setting, and through potential compendia inclusion starting in 2027," said Mohamed Zaki, Chief Medical Officer. "We look forward to the presentation of the LOTIS-5, LOTIS-7 and MZL investigator-initiated trial data later this year and expect submission for publication. In addition, we expect to submit LOTIS-7 and MZL data to the FDA for Breakthrough Designation."