Immatics Announces Full Year 2021 Financial Results and Corporate Update
03/23/2022 - 07:00 AM
IMA203 TCR-T candidate targeting PRAME demonstrated a 50 % objective response rate across different solid tumor types in an interim update of Phase 1a dose escalation M ultiple IMA203 Ph ase 1b expansion cohorts being initiated in Q2 2022 including monotherapy at target dose level , checkpoint combination therapy , and 2 nd -generation appr oa ch IMA203CD8 Immatics entered a global licensing agreement with Bristol Myers Squibb to collaborate on clinical development of TCR Bispecific ( TCER® ) IMA401 targeting MAGEA4/A8 ; agreement include s $150million upfront payment, up to $ 770 million in milestone payments, tiered double-digit royalties and a co- promotion option in the U . S . TCER ® IMA 401 IND 1 approved by regulatory authorities in February 2022 ; i nitiation of patient treatment in the first half of 2022 TCER® IMA402 targeting PRAME demonstrated preclinical proof-of-concept and initial steps towards GMP m anufacturing have been initiated Nancy Valente appointed to Immatics ’ Board of Directors Cash and cash equivalents as well as O ther financial assets amount to $ 164 million 2 ( € 145 million) as of December 31, 202 1 . A ddi tion of upfront payment from the recent collaboration agreement with B ristol M yers S quibb received in February 2022 ensure s cash runway into 202 4 Tuebingen , Germany and Houston, TX , March 2 3 , 20 2 2 – Immatics N.V. (NASDAQ: IMTX; “Immatics”), a clinical-stage biopharmaceutical company active in the discovery and development of T cell redirecting cancer immunotherapies, today provided an update on its corporate progress and reported financial results for the quarter and full year ended December 31, 2021.
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 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 202 1 and Subsequent Company Progress
Adoptive Cell Therapy Programs
ACTengine® IMA 203 (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) 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 Progra ms
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 Development s
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 202 1 Financial Results
Cash Position: Cash and cash equivalents as well as other financial assets total €145.1 million ($164.3 million 2 ) as of December 31, 2021 compared to €232.0 million ($262.7 million 2 ) 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 million 2 ) for the year ended December 31, 2021, compared to €31.3 million ($35.4 million 2 ) for the year ended December 31, 2020.
Research and Development Expenses: R&D expenses were €87.6 million ($99.2 million 2 ) for the year ended December 31, 2021, compared to €67.1 million ($76.0 million 2 ) 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 million 2 ) for the year ended December 31, 2021, compared to €34.2 million ($38.7 million 2 ) for the year ended December 31, 2020.
Net Loss: Net loss was €93.3 million ($105.7 million 2 ) for the year ended December 31, 2021, compared to €211.8 million ($239.9 million 2 ) 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 million 2 ).
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 .
About Immatics
Immatics intends to use its website www.immatics.com as a means of disclosing material non-public information. For regular updates you can also follow us on Twitter , Instagram and LinkedIn .
Forward-Looking Statements
For more information, please contact:
Media and Investor Relations Contact Jacob Verghese or Stephanie May Trophic Communications Phone: +49 89 2388 7731 immatics@trophic.eu
1 Genehmigung des Studienzulassungsantrages (clinical trial application, CTA)
2 Alle Beträge wurden mit dem von der Europäischen Zentralbank veröffentlichten Wechselkurs zum 31. Dezember 2021 umgerechnet (1 EUR = 1,1326 US-Dollar).
Immatics N.V. and subsidiaries Condensed Consolidated Statement of Financial Position of Immatics N.V.
As of December 31, 2021 December 31, 2020 (Euros in thousands) Assets Current assets Cash and cash equivalents 132,994 207,530 Other financial assets 12,123 24,448 Accounts receivable 682 1,250 Other current assets 6,408 5,763 Total current assets 152,207 238,991 Non-current assets Property, plant and equipment 10,506 7,868 Intangible assets 1,315 914 Right-of-use assets 9,982 6,149 Other non-current assets 636 724 Total non-current assets 22,439 15,655 Total assets 174,646 254,646 Liabilities and shareholders’ equity Current liabilities Provisions 51 51 Accounts payable 11,624 10,052 Deferred revenue 50,402 46,600 Other financial liabilities 27,859 16,869 Lease liabilities 2,711 1,881 Other current liabilities 2,501 2,025 Total current liabilities 95,148 77,478 Non-current liabilities Deferred revenue 48,225 85,475 Lease liabilities 7,142 4,306 Other non-current liabilities 68 — Total non-current liabilities 55,43 5 89,781 Shareholders’ equity Share capital 629 629 Share premium 565,192 538,695 Accumulated deficit (537,813) (444,478) Other reserves (3,945) (7,459) Total shareholders’ equity 24,063 87,387 Total liabilities and shareholders’ equity 174,646 254,646
Immatics N.V. and subsidiaries Condensed Consolidated Statement of Loss of Immatics N.V.
Year ended December 31, 2021 2020 2019 (Euros in thousands, except share and per share data) Revenue from collaboration agreements 34,763 31,253 18,449 Research and development expenses (87,574) (67,085) (40,091) General and administrative expenses (33,808) (34,186) (11,756) Other income 332 303 385 Operating result (86,294) (69,715) (33,013 ) Financial income 5,675 2,949 790 Financial expenses (1,726) (10,063) (264) Change in fair value of warrant liabilities (10,990) 17,775 — Share listing expense - (152,787) — Financial result (7,041) (142,126 ) 526 Loss before taxes (93,335) (211,841 ) (32,487 ) Taxes on income — — — Net loss (93,335) (211,841 ) (32,487 ) Attributable to: Equity holders of the parent (93,335) (211,284) (31,571) Non-controlling interest - (557) (916) Net loss (93,335) (211,841 ) (32,487 ) Net loss per share - basic and diluted (1.4 8 ) (4.40 ) (0.95 ) Weighted average shares outstanding - basic and diluted 62,912,921 48,001,228 33,093,838
Immatics N.V. and subsidiaries Condensed Consolidated Statement of Comprehensive Loss of Immatics N.V.
Year ended December 31, 2021 2020 2019 (Euros in thousands) Net Loss (93,335) (211,841 ) (32,487 ) Other comprehensive loss Items that may be reclassified subsequently to profit or loss, net of tax — — — Currency translation differences from foreign operations 3,514 (6,689) (29) Total comprehensive loss for the period (89,821) (218,530 ) (32,516 ) Attributable to: Equity holders of the parent (89,821) (217,973) (31,600) Non-controlling interest — (557) (916) Total comprehensive loss for the period (89,821) (218,530 ) (32,516 )
Immatics N.V. and subsidiaries Condensed Consolidated Statement of Cash Flows of Immatics N.V.
Year ended December 31, 2021 2020 2019 (Euros in thousands) Cash flows from operating activities Loss before taxation (93,335) (211,841 ) (32,487 ) Adjustments for: Interest income (133) (850) (790) Depreciation and amortization 5,260 4,424 3,858 Interest expense 566 289 170 Share listing expense — 152,787 — Equity settled share-based payment 26,403 22,908 152 MD Anderson compensation expense — 45 700 (Decrease) Increase in other liabilities resulting from share appreciation rights — (2,036) 1,864 Payment related to share-based compensation awards previously classified as equity-settled — (4,322) — Net foreign exchange differences 554 (4,477) 3 Change in fair value of warrant liabilities 10,990 (17,775) — Changes in working capital Decrease (increase) in accounts receivable 569 (294) (563) (Increase) in other assets (483) (1,600) (1,497) (Decrease) increase in accounts payable and other current liabilities (31,784) (23,387) 98,937 Interest received 175 808 790 Interest paid (566) (289) (170) Net cash used in operating activities (81,784) (85,610 ) 70,967 Cash flows from investing activities Payments for property, plant and equipment (5,106) (7,420) (2,143) Cash paid for investments in Other financial assets (11,298) (58,087) (77,810) Cash received from maturity of investments classified in Other financial assets 24,448 49,662 74,888 Payments for intangible assets (551) (104) (91) Proceeds from disposal of property, plant and equipment — — 97 Net cash (used in)/provided by investing activities 7,493 (15,949 ) (5,059 ) Cash flows from financing activities Proceeds from issuance of shares to equity holders of the parent 94 217,918 — Transaction cost deducted from equity — (7,939) — Payments for leases (2,707) (2,096) (1,862) Net cash used in financing activities (2,61 3 ) 207,883 (1,862 ) Net increase in cash and cash equivalents (76,904) 106,324 64,046 Cash and cash equivalents at beginning of period 207,530 103,353 39,367 Effects of exchange rate changes on cash and cash equivalents 2,368 (2,147) (60) Cash and cash equivalents at end of period 132,994 207,530 103,353
Immatics N.V. and subsidiaries Condensed Consolidated Statement of Changes in Shareholders’ equity (deficit) of Immatics N.V.
(Euros in thousands) Share capital Share premium Accumulated deficit Other reserves Total equity (deficit)ccc attributable to shareholders of the parent Non- controlling interest Total share- holders’ equity (deficit) Balance as of January 1, 2019 1,164 190,793 (201,623 ) (741 ) (10,407 ) 1,236 (9,171 ) Other comprehensive loss — — — (29) (29) — (29) Net loss — — (31,571) — (31,571) (916) (32,487) Comprehensive loss for the year — — (31,571 ) (29 ) (31,600 ) (916 ) (32,516 ) Equity-settled tandem awards — 152 — — 152 — 152 MD Anderson compensation expense — — — — — 700 700 Balance as of December 31, 2019 1,164 190,945 (233,194 ) (770 ) (41,855 ) 1,020 (40,835 ) Balance as of January 1, 2020 1,164 190,945 (233,194 ) (770 ) (41,855 ) 1,020 (40,835 ) Other comprehensive loss — — — (6,689) (6,689) — (6,689) Net loss — — (211,284) — (211,284) (557) (211,841) Comprehensive loss for the year — — (211,284 ) (6,689 ) (217,973 ) (557 ) (218,530 ) Reorganization (833) 833 — — — — — Issue of share capital MD Anderson Share Exchange 7 501 — — 508 (508) — PIPE Financing, net of transaction costs 104 89,973 — — 90,077 — 90,077 ARYA Merger, net of transaction 180 237,864 — — 238,044 — 238,044 SAR conversion 7 (7) — — — — — Total issuance of share capital 298 328,331 — — 328,629 (508 ) 328,121 Equity-settled share-based compensation — 22,908 — — 22,908 — 22,908 Payment related to share-based compensation awards previously classified as equity-settled — (4,322) — — (4,322) — (4,322) MD Anderson milestone compensation expense — — — — — 45 45 Balance as of December 31, 2020 629 538,695 (444,478 ) (7,459 ) 87,387 — 87,387 Balance as of January 1, 2021 629 538,695 (444,478 ) (7,459 ) 87,387 — 87,387 Other comprehensive income — — — 3,514 3,514 — 3,514 Net loss — — (93,335) — (93,335) — (93,335) Comprehensive income/(loss) for the year — — (93,335) 3,514 (89,821) — (89,821) Equity-settled share-based compensation — 26,403 — — 26,403 — 26,403 Share options exercised — 94 — — 94 — 94 Balance as of December 31, 2021 629 565,192 (537,813) (3,945) 24,063 — 24,063
