On June 2, 2022 Immatics N.V. (NASDAQ: IMTX, "Immatics"), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, reported financial results and provided a business update for the quarter ended March 31, 2022 (Press release, Immatics, JUN 2, 2022, View Source [SID1234615438]).
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Harpreet Singh, Ph.D., CEO and Co-Founder of Immatics commented, "Immatics has continued to build positive momentum in the first quarter of 2022. We have started treatment in two of three Phase 1b cohorts advancing our IMA203 TCR-T studies targeting PRAME. We have reached a key milestone by entering the first-in-human trial with our first TCR Bispecifics candidate directed against MAGEA4/A8 and have set the stage for further advancing our TCER pipeline. We have also further strengthened our pipeline portfolio to address the needs of cancer patients by joining forces with Bristol Myers Squibb to develop multiple off-the-shelf TCR-T and/or CAR-T programs based on our allogeneic gamma-delta cell therapy platform ACTallo."
First Quarter 2022 and Subsequent Company Progress
Adoptive Cell Therapy Programs
ACTallo and Autologous TCR-T – Immatics entered into a strategic multi-program collaboration with Bristol Myers Squibb to develop allogeneic TCR-T/CAR-T programs combining Immatics’ proprietary gamma-delta T cell-derived, allogeneic Adoptive Cell Therapy (ACT) platform ACTallo, with a suite of next-generation technologies developed by Bristol Myers Squibb. Immatics will receive an upfront payment of $60 million and is eligible for up to $700 million per Bristol Myers Squibb program through development, regulatory and commercial milestone payments and tiered royalty payments up to low double-digit percentages on net sales. The new collaboration covers development and commercialization of two programs for Bristol Myers Squibb. Both companies have an option to develop up to four additional programs each. In addition, Bristol Myers Squibb and Immatics will expand their autologous T cell receptor-based therapy (TCR-T) collaboration signed in 2019 by including one additional TCR-T target discovered by Immatics. Immatics will receive a payment of $20 million and eligibility for milestone payments as well as tiered royalties.
ACTengine IMA203 (PRAME) – Update on Phase 1b expansion cohorts:
Cohort A – IMA203 as monotherapy: First patient treated at provisional Recommended Phase 2 Dose (RP2D) in March
Cohort B – IMA203 in combination with an immune checkpoint inhibitor: First patient treated at RP2D in May
Cohort C – IMA203CD8, a 2nd generation monotherapy where IMA203 is co-transduced with a CD8 co-receptor: IND granted by FDA, patient enrollment planned for Q2 2022
The next data read-out for the IMA203 monotherapy cohort is planned for 2H 2022. An initial data read-out for the IMA203/immune checkpoint inhibitor combination therapy cohort and the IMA203CD8 cohort is planned for YE2022.
ACTengine IMA201 (MAGEA4/A8) – Dose escalation is ongoing, target dose level to commence.
ACTengine IMA202 (MAGEA1) – A preliminary interim analysis from 16 patients treated in the dose escalation cohort demonstrated a favorable tolerability profile for IMA202. Signs of clinical and biological activity were observed, but were not reaching the threshold of objective responses as per RECIST1.1. Treatment-emergent adverse events for IMA202 were transient and manageable. No dose-limiting toxicities or signs of auto-immune toxicities were observed. 11 out of 16 patients (69%) showed disease control and 5 out of 16 patients (31%) showed tumor shrinkage. Maximum change of target lesion was minus 35%. Following final evaluation, Immatics plans to present the full data set at a later timepoint. Immatics management has decided not to further progress the IMA202 program into Phase 1b dose expansion and is evaluating development options and partnering opportunities for the program and the target MAGEA1.
TCR Bispecifics Programs
TCER IMA401 (MAGEA4/8) – Immatics initiated a Phase 1 clinical trial with its T cell engaging receptor (TCER) IMA401 for patients with recurrent and/or refractory solid tumors. IMA401 is the most advanced TCER candidate and targets an HLA-A*02-presented peptide derived from both MAGEA4 and/or MAGEA8. TCER IMA401 is being developed in collaboration with Bristol Myers Squibb. Immatics is responsible for conducting the Phase 1 clinical trial with approximately 50 patients at up to 15 centers in Germany.
TCER IMA402 (PRAME) – Manufacturing of the clinical batch is on track for the 2H 2022 and initiation of the Phase 1 trial is planned in 2023.
Corporate Developments
Board of Directors Update
Nancy Valente, M.D., was appointed to Immatics’ Board of Directors in March 2022 and will be nominated for election at Immatics’ Annual General Meeting in June 2022. She brings over 20 years of experience in oncology and hematology drug development. Additional information on all members of Immatics’ Board of Directors can be found on the Immatics website.
First Quarter 2022 Financial Results
Cash Position: Cash and cash equivalents as well as other financial assets total €252.7 million ($280.5 million1) as of March 31, 2022 compared to €145.1 million ($161.1 million1) as of December 31, 2021. The increase is mainly due to the receipt of the upfront payment in connection with the collaboration agreement with Bristol Myers Squibb on IMA401, partly offset by the financing of our ongoing research and development activities. This does not include $60 million cash to be received from the collaboration agreement signed with Bristol Myers Squibb in May 2022 or the $20 million cash to be received as a result of Bristol Myers Squibb’s decision to add one additional autologous TCR-T target as part of a 2019 collaboration agreement. With the addition of these upfront payments, the Company projects a cash runway into 2H 2024.
Revenue: Total revenue, consisting of revenue from collaboration agreements, was €102.9 million ($114.2 million1) for the three months ended March 31, 2022, compared to €7.4 million ($8.2 million1) for the three months ended March 31, 2021. The increase is mainly related to the recognition of revenue for the license portion of the collaboration agreement with Bristol Myers Squibb on IMA401.
Research and Development Expenses: R&D expenses were €25.1 million ($27.9 million1) for the three months ended March 31, 2022, compared to €23.0 million ($25.5 million1) for the three months ended March 31, 2021.
General and Administrative Expenses: G&A expenses were €9.3 million ($10.3 million1) for the three months ended March 31, 2022, compared to €8.4 million ($9.3 million1) for the three months ended March 31, 2021.
Net Income/Loss: Net income was €85.7 million ($95.1 million1) for the three months ended March 31, 2022, compared to a net loss of €22.8 million ($25.3 million1) for the three months ended March 31, 2021. The increase mainly resulted from a one-time revenue in connection with the partial recognition of the upfront payment from the collaboration with Bristol Myers Squibb on IMA401.
Full financial statements can be found in the current report on Form 6-K filed with the Securities and Exchange Commission (SEC) and published on the SEC website under www.sec.gov.
1 All amounts translated using the exchange rate published by the European Central Bank in effect as of March 31, 2022 (1 EUR = 1.1101 USD).
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