EX-99.1 2 dp169672_ex9901.htm EXHIBIT 99.1

Exhibit 99.1

 

 

 

PRESS RELEASE

 

Immatics Announces Full Year 2021 Financial Results
and Corporate Update

 

·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, 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 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.”

 

 

1 Clinical Trial Application (CTA) approved, the equivalent of an Investigational New Drug (IND) application in Europe

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)

 

Immatics Press Release March 23, 2022 1 | 10

 

 

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.

 

Immatics Press Release March 23, 2022 2 | 10

 

 

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.

 

Immatics Press Release March 23, 2022 3 | 10

 

 

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.

 

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.

 

 

 

 

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).

 

Immatics Press Release March 23, 2022 4 | 10

 

 

 

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

 

Immatics Press Release March 23, 2022 5 | 10

 

 

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 Press Release March 23, 2022 6 | 10

 

 

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 Press Release March 23, 2022 7 | 10

 

 

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 Press Release March 23, 2022 8 | 10

 

 

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 Press Release March 23, 2022 9 | 10

 

 

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, 2021   629    565,192    (537,813)   (3,945)   24,063        24,063 

 

 

Immatics Press Release March 23, 2022 10 | 10