Immatics Announces First Quarter 2022 Financial Results and Business Update

2022-06-02

合作财报细胞疗法

ACTengine® IMA203: First patients treated at RP2D in Phase 1b cohort A with IMA203 monotherapy as well as Phase 1b cohort B with IMA203/checkpoint inhibitor combination. IND for Phase 1b cohort C with 2nd-generation IMA203CD8 granted Phase 1 clinical trial initiated with the first T cell engaging receptor TCER® IMA401 targeting MAGEA4/8 for patients with recurrent and/or refractory solid tumors New multi-program collaboration with Bristol Myers Squibb to develop allogeneic TCR-T/CAR-T programs; agreement includes $60 million upfront payment to Immatics and up to $700 million per program in milestone payments as well as tiered royalties Bristol Myers Squibb and Immatics are also including an additional target to their autologous TCR-T collaboration signed in 2019, Immatics to receive an upfront payment of $20 million and eligibility for milestone payments and royalties Cash and cash equivalents as well as other financial assets of $280.5 million1 (€252.7 million) as of March 31, 2022. With the upfront payment from the new collaboration agreement with Bristol Myers Squibb, cash reach into 2H 2024 Tuebingen, Germany and Houston, Texas,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, today reported financial results and provided a business update for the quarter ended March 31, 2022. 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 pro 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 . 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). Upcoming Investor Conferences Jefferies Global Healthcare Conference (in-person) New York, NY – June 8-10, 2022 Jefferies London Healthcare Conference, London, U.K. – November 15-17, 2022 To see the full list of events and presentations, visit . - END - About Immatics Immatics combines the discovery of true targets for cancer immunotherapies with the development of the right T cell receptors with the goal of enabling a robust and specific T cell response against these targets. This deep know-how is the foundation for our pipeline of Adoptive Cell Therapies and TCR Bispecifics as well as our partnerships with global leaders in the pharmaceutical industry. We are committed to delivering the power of T cells and to unlocking new avenues for patients in their fight against cancer. For regular updates about Immatics, visit . You can also follow us on Instagram, Twitter and LinkedIn. Forward-Looking Statements: Certain statements in this press release may be considered forward-looking statements. Forward-looking statements generally relate to future events or Immatics’ future financial or operating performance. For example, statements concerning the timing of product candidates and Immatics’ focus on partnerships to advance its strategy are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may”, “should”, “expect”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”, “potential” or “continue”, or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Immatics and its management, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Factors that may cause actual results to differ materially from current expectations include, but are not limited to, various factors beyond management's control including general economic conditions and other risks, uncertainties and factors set forth in filings with the SEC. Nothing in this presentation should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Immatics undertakes no duty to update these forward-looking statements. All the scientific and clinical data presented within this press release are – by definition prior to completion of the clinical trial and a clinical study report – preliminary in nature and subject to further quality checks including customary source data verification. For more information, please contact: Media and Investor Relations Contact Jacob Verghese or Eva Mulder Trophic Communications Phone: +49 89 2070 89831 or +31 6 52 33 1579 immatics@trophic.eu Immatics N.V. Anja Heuer Jordan Silverstein Director, Corporate Communications Head of Strategy Phone: +49 89 540415-606 Phone: +1 281 810 7545 media@immatics.com InvestorRelations@immatics.com Unaudited Condensed Consolidated Statement of Financial Position of Immatics N.V. As of March 31, 2022 December 31, 2021 (Euros in thousands) Assets Current assets Cash and cash equivalents 247,316 132,994 Other financial assets 5,428 12,123 Accounts receivable 742 682 Other current assets 6,432 6,408 Total current assets 259,918 152,207 Non-current assets Property, plant and equipment 10,801 10,506 Intangible assets 1,287 1,315 Right-of-use assets 9,297 9,982 Other non-current assets 879 636 Total non-current assets 22,264 22,439 Total assets 282,182 174,646 Liabilities and shareholders’ equity Current liabilities Provisions 1,405 51 Accounts payable 13,304 11,624 Deferred revenue 61,444 50,402 Other financial liabilities 11,331 27,859 Lease liabilities 2,770 2,711 Other current liabilities 1,600 2,501 Total current liabilities 91,854 95,148 Non-current liabilities Deferred revenue 67,787 48,225 Lease liabilities 6,491 7,142 Other non-current liabilities 63 68 Total non-current liabilities 74,341 55,435 Shareholders’ equity Share capital 629 629 Share premium 570,894 565,192 Accumulated deficit (452,151) (537,813) Other reserves (3,385) (3,945) Total shareholders’ equity 115,987 24,063 Total liabilities and shareholders’ equity 282,182 174,646 Unaudited Condensed Consolidated Statement of Income/(Loss) of Immatics N.V. Three months ended March 31, 2022 2021 (Euros in thousands, except share and per share data) Revenue from collaboration agreements 102,907 7,403 Research and development expenses (25,144) (23,049) General and administrative expenses (9,278) (8,431) Other income 7 239 Operating result 68,492 (23,838) Financial income 1,759 3,464 Financial expenses (1,117) (1,224) Change in fair value of warrant liabilities 16,528 (1,215) Financial result 17,170 1,025 Income/(loss) before taxes 85,662 (22,813) Taxes on income — — Net income/(loss) 85,662 (22,813) Net income/(loss) per share: Basic 1.36 (0.36) Diluted 1.35 (0.36) Weighted average shares outstanding: Basic 62,927,205 62,908,791 Diluted 63,402,023 62,908,791 Unaudited Condensed Consolidated Statement of Comprehensive Income/(Loss) of Immatics N.V. Three months ended March 31, 2022 2021 (Euros in thousands) Net income/(loss) 85,662 (22,813) Other comprehensive income/(loss) Items that may be reclassified subsequently to profit or loss, net of tax Currency translation differences from foreign operations 560 2,725 Total comprehensive income/(loss) for the period 86,222 (20,088) Unaudited Condensed Consolidated Statement of Cash Flows of Immatics N.V. Three months ended March 31, 2022 2021 (Euros in thousands) Cash flows from operating activities Income/(loss) before taxation 85,662 (22,813) Adjustments for: Interest income (6) (49) Depreciation and amortization 1,636 1,094 Interest expense 162 70 Equity settled share-based payment 5,702 8,304 Net foreign exchange differences 126 318 Change in fair value of warrant liabilities (16,528) 1,215 Changes in: (Increase)/decrease in accounts receivable (61) 676 (Increase)/decrease in other assets (235) 1,207 Increase/(decrease) in accounts payable and other current liabilities 32,800 (6,645) Interest received 6 36 Interest paid (162) (70) Net cash (used in)/provided by operating activities 109,102 (16,657) Cash flows from investing activities Payments for property, plant and equipment (1,156) (565) Cash paid for investments classified in Other financial assets — — Cash received from maturity of investments classified in Other financial assets 6,993 3,126 Payments for intangible assets (2) (6) Proceeds from disposal of property, plant and equipment 1 4 Net cash (used in)/provided by investing activities 5,836 2,559 Cash flows from financing activities Proceeds from issuance of shares to equity holders of the parent — — Payments for leases (689) (482) Net cash (used in)/provided by financing activities (689) (482) Net increase/(decrease) in cash and cash equivalents 114,249 (14,580) Cash and cash equivalents at beginning of period 132,994 207,530 Effects of exchange rate changes on cash and cash equivalents 73 2,383 Cash and cash equivalents at end of period 247,316 195,333 Unaudited Condensed Consolidated Statement of Changes in Shareholders’ equity of Immatics N.V. (Euros in thousands) Share capital Share premium Accumulated deficit Other reserves Total share- holders’ equity Balance as of January 1, 2021 629 538,695 (444,478) (7,459) 87,387 Other comprehensive income — — — 2,725 2,725 Net loss — — (22,813) — (22,813) Comprehensive income/(loss) for the year — — (22,813) 2,725 (20,088) Equity-settled share-based compensation — 8,304 — — 8,304 Balance as of March 31, 2021 629 546,999 (467,291) (4,734) 75,603 Balance as of January 1, 2022 629 565,192 (537,813) (3,945) 24,063 Other comprehensive income — — — 560 560 Net loss — — 85,662 — 85,662 Comprehensive income/(loss) for the year — — 85,662 560 86,222 Equity-settled share-based compensation — 5,702 — — 5,702 Share options exercised — — — — — Balance as of March 31, 2022 629 570,894 (452,151) (3,385) 115,987 Attachment PDF Version