Immatics Announces Full Year 2021 Financial Results and Corporate Update

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  • 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
  • Multiple IMA203 Phase 1b expansion cohorts being initiated in Q2 2022 including monotherapy at target dose level, checkpoint combination therapy, and 2nd-generation approach 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 includes $150million upfront payment, up to $770 million in milestone payments, tiered double-digit royalties and a co-promotion option in the U.S.
  • TCER® IMA401 IND1 approved by regulatory authorities in February 2022; initiation of patient treatment in the first half of 2022
  • TCER® IMA402 targeting PRAME demonstrated preclinical proof-of-concept and initial steps towards GMP manufacturing have been initiated
  • Nancy Valente appointed to Immatics Board of Directors
  • Cash and cash equivalents as well as Other financial assets amount to $164 million2 (145 million) as of December 31, 2021. Addition of upfront payment from the recent collaboration agreement with Bristol Myers Squibb received in February 2022 ensures cash runway into 2024

Tuebingen, Germany and Houston, TX, March 23, 2022Immatics 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 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) 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.

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.

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
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.

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  


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

 



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        55,435        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        (1.48)        (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        (2,613)        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
costs
        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, 2021629565,192(537,813)(3,945)24,06324,063
        

        

 

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