On March 23, 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 for the quarter and full year ended December 31, 2021 (Press release, Immatics, MAR 23, 2022, View Source [SID1234610677]).
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Harpreet Singh, Ph.D., CEO and Co-Founder of Immatics commented, "Over the course of 2021, Immatics has continued to deliver important milestones across both our clinical and preclinical portfolio. Our Phase 1a data presentation at SITC (Free SITC Whitepaper) demonstrated high initial objective response rates in solid cancer patients treated with our ACTengine IMA203 TCR-T candidate, and we have achieved preclinical proof-of-concept for our TCR Bispecific candidate, TCER IMA402 – both targeting PRAME, a target frequently expressed on multiple solid cancers. We have also expanded our collaboration with Bristol Myers Squibb to jointly develop our TCER IMA401 targeting MAGEA4 and MAGEA8 and we plan to initiate the first-in-man clinical trial of IMA401 in the first half of 2022. Together with the company’s strong cash position and further potential opportunities to create valuable partnerships based on our differentiated TCR-based platforms, we are very well positioned to deliver on all relevant upcoming value inflections points across our cell therapy and bispecifics portfolio."
Fourth Quarter 2021 and Subsequent Company Progress
Adoptive Cell Therapy Programs
ACTengine IMA203 (PRAME) – Immatics provided an interim update on its most advanced Phase 1a TCR-T trial with IMA203 targeting PRAME in a late-breaking oral presentation by Dr. Martin Wermke, coordinating investigator of the trial, at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in November 2021. Objective responses (confirmed and unconfirmed partial responses, RECIST 1.1) were observed in 8 out of 16 patients (50%), and 8 out of 13 patients (62%) who were treated at intermediate dose levels 2 and 3 in the dose escalation part of the trial. Objective responses were associated with tumor infiltration and peak T cell persistence in the blood. Treatment-emergent events were transient and manageable; no grade 3 or higher cytokine release syndrome or neurological toxicities were observed.
Patient treatment in the Phase 1a study with IMA203 has been completed. Dose level 4 (up to 1.2 billion transduced T cells per m2) has been determined as the provisional Recommended Phase 2 Dose (RP2D). The next data read-out for IMA203 monotherapy is planned for 2H 2022.
Based on these interim results, Immatics is expanding the IMA203 study to three Phase 1b dose expansion cohorts, each designed to evaluate the observed objective response rate, demonstrate durability of response and provide the basis for entering registration trials. Cohorts include IMA203 as monotherapy in focus indications, IMA203 in combination with an immune checkpoint inhibitor and IMA203CD8, a 2nd generation monotherapy where IMA203 is co-transduced with a CD8 co-receptor, thereby inducing anti-tumor activity of both CD4 and CD8 T cells. These three Phase 1b IMA203 expansion cohorts are being initiated in Q2 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 (MAGEA4/8) and IMA202 (MAGEA1) – In November 2021, Immatics presented interim data on 12 heavily pre-treated patients that were treated with product candidates IMA201 and IMA202. 8 out of 12 patients (67%) showed disease control, and tumor shrinkage was observed in 6 patients (50%). All adverse events for IMA201 and IMA202 were transient and manageable with no dose-limiting toxicities observed. For IMA202, patient recruitment in the dose escalation part of the Phase 1 trial has been completed. For IMA201, dose escalation is ongoing.
ACTengine IMA204 (COL6A3 exon 6) – IMA204 is a first-in-class TCR-T directed against COL6A3 exon 6, a novel tumor stroma target highly expressed in several solid cancers. IMA204 utilizes a next-generation CD8-independent TCR with full functionality in both CD4 and CD8 T cells. IND-enabling studies are nearing completion. Submission of the IND application for IMA204 is expected by the end of 2022.
TCR Bispecifics Programs
TCER IMA401 (MAGEA4/8) – Immatics entered a global exclusive licensing deal with Bristol Myers Squibb for its most advanced TCER product candidate, IMA401. The agreement included an upfront payment of $150 million as well as up to $770 million in additional milestone payments plus tiered double-digit royalties on net product sales, and includes the retention of the option to co-fund U.S. development in return for further enhanced U.S. royalties. Both companies will collaborate to advance the program through clinical development with Immatics retaining a co-promotion option in the U.S. In preclinical proof-of-concept studies, IMA401 demonstrated anti-tumor activity with complete remissions in different in vivo tumor models including patient-derived xenograft models. A clinical trial application (CTA, the equivalent of an IND in Europe) for the IMA401 program was filed in November 2021 with the Paul-Ehrlich-Institute, the relevant German regulatory authority and approved in February 2022. Start of the Phase 1 clinical trial is planned for the first half of 2022.
TCER IMA402 (PRAME) – Immatics presented data from its second TCER program IMA402 at the 17th Annual PEGS Boston Protein Engineering and Cell Therapy Summit in May 2021 demonstrating preclinical proof-of-concept for the program. IMA402 showed in vitro anti-tumor activity and consistent tumor regression including complete responses in an in vivo tumor model. Continuation of GMP process development and IND-enabling activities for IMA402 is anticipated in 2022. Manufacturing of the clinical batch is targeted for the second half of 2022 and initiation of the Phase 1 trial is planned in 2023.
Corporate Developments
Board of Directors Update
In March 2022, Nancy Valente, M.D., was appointed to the Immatics’ Board of Directors and will be nominated for election at the Company’s Annual General Meeting in June 2022. Nancy Valente brings to Immatics over 20 years of experience in oncology and hematology drug development. In her last position at Genentech/Roche, she was Senior Vice President, Oncology Product Development, where she helped to build a diverse portfolio of new oncology therapies encompassing small molecules, antibodies, bispecific antibodies and antibody drug conjugates including Gazyva, Polivy, Hemlibra and Venclexta, a first-to-market BCL-2 inhibitor. Additional information about Nancy Valente and the other members of Immatics’ Board of Directors can be found on the Immatics website.
In July 2021, Immatics adopted a one-tier structure for its Board of Directors. As part of this process, the company’s CEO Harpreet Singh, Ph.D., joined the Board.
In June 2021, Friedrich von Bohlen und Halbach, Ph.D., Managing Director of dievini Hopp BioTech Holding GmbH & Co. KG was elected to Immatics’ Board of Directors. Dr. von Bohlen und Halbach replaced Christof Hettich, L.L.D., who stepped down from the Board of Directors after 15 years of valuable service to the company.
Full Year 2021 Financial Results
Cash Position: Cash and cash equivalents as well as other financial assets total €145.1 million ($164.3 million2) as of December 31, 2021 compared to €232.0 million ($262.7 million2) as of December 31, 2020. The decrease is mainly the result of financing of our ongoing research and development activities. This does not include $150 million cash received in February 2022 from the collaboration agreement signed with Bristol Myers Squibb in December 2021. Adding this upfront payment, the Company projects a cash runway into 2024.
Revenue: Total revenue, consisting of revenue from collaboration agreements, was €34.8 million ($39.4 million2) for the year ended December 31, 2021, compared to €31.3 million ($35.4 million2) for the year ended December 31, 2020.
Research and Development Expenses: R&D expenses were €87.6 million ($99.2 million2) for the year ended December 31, 2021, compared to €67.1 million ($76.0 million2) for the year ended December 31, 2020. The increase mainly resulted from higher costs associated with the advancement of the clinical and pre-IND pipeline of candidates.
General and Administrative Expenses: G&A expenses were €33.8 million ($38.3 million2) for the year ended December 31, 2021, compared to €34.2 million ($38.7 million2) for the year ended December 31, 2020.
Net Loss: Net loss was €93.3 million ($105.7 million2) for the year ended December 31, 2021, compared to €211.8 million ($239.9 million2) for the year ended December 31, 2020. The decrease mainly resulted from a one-time, non-cash expense in connection with the ARYA merger in 2020 of €152.8 million ($173.0 million2).
Full financial statements can be found in the Annual Report on Form 20-F filed with the Securities and Exchange Commission (SEC) and published on the SEC website under www.sec.gov.
2 All amounts translated using the exchange rate published by the European Central Bank in effect as of December 31, 2021 (1 EUR = 1.1326 USD).
Upcoming Investor Conferences
Bank of America Healthcare Conference (in person) Las Vegas, NV – May 10-12, 2022
Jefferies LLC Healthcare Conference (in-person) New York, NY – June 8-10, 2022
Goldman Sachs Global Healthcare Conference, Rancho Palos Verdes, CA – June 14-16, 2022
Jefferies LLC London Healthcare Conference, London, U.K. – November 15-17, 2022
To see the full list of events and presentations, visit www.investors.immatics.com/events-presentations.