- ACTengine® patient recruitment remains on track; as of end of July, a total of 27 patients have been treated with IMA201, IMA202 or IMA203 across different cancer indications
- TCR Bispecifics pipeline advancing with progress towards clinical trial initiation of IMA401 and preclinical proof-of-concept for second TCER® molecule IMA402
- Cash and cash equivalents as well as Other financial assets of $229.1 million1 (€192.8 million) as of June 30, 2021, funding company operations into 2023
Tuebingen,
“An important development during the second quarter of 2021 was a significant increase in patient enrollment for our ACTengine® programs,” said
“In addition to the upcoming clinical data for our ACTengine® trials, we are excited to move our second therapeutic modality towards the clinic,” added
Second Quarter 2021 and Subsequent Company Progress
Adoptive Cell Therapy Programs
- ACTengine® IMA200 series – Patient recruitment remains on track and the additional trial sites initiated in
Europe and the US have supported the acceleration of recruitment. As of end of July, 27 patients have been treated in the IMA200 series. The first-in-human basket trials for IMA201, IMA202 and IMA203 include patients with recurrent and/or refractory solid cancers utilizing TCR-engineered T cells (TCR-T) directed against the cancer targets MAGEA4/A8, MAGEA1 and PRAME, respectively. - In
March 2021 ,Immatics reported initial safety and biological data as well as data showing first clinical anti-tumor activity for 10 patients enrolled in these trials. Patients were treated at initial dose levels below one billion transduced cells, which was presumed to be sub-therapeutic as per data published from across the industry. - The next data update, which will cover safety, biological activity, and the assessment of anti-tumor activity across different cancer indications, including patients treated at higher dose levels (dose levels 2 and 3), will be provided by the company within the second half of 2021.
TCR Bispecifics Programs
- IMA401 –
Immatics has discussed the proposed clinical trial design for its first TCER® program IMA401, as well as the preclinical data package covering safety and efficacy data in a scientific advisory meeting2 with thePaul-Ehrlich Institute , the German regulatory authority. The company also completed the first Good Manufacturing Practices (GMP) production batch delivering a high production yield. IMA401 remains on track for submission of a CTA in the fourth quarter of 2021 and patient recruitment will be initiated in the first half 2022. - IMA402 – The company presented preclinical proof-of-concept data on IMA402 at the 17th Annual PEGS Boston Protein Engineering and Cell Therapy Summit in May. IMA402 is directed against a peptide derived from the cancer target PRAME, a protein that is frequently expressed in many solid cancers, thereby supporting the program’s potential to address a broad range of cancer patients and indications. Data demonstrated tumor cell killing in vitro and complete regressions of established tumors in an in vivo tumor model.
Immatics has selected a lead candidate for the clinical program and initiated manufacturing activities.
Corporate Development
- As of
July 1, 2021 ,Immatics adopted a one-tier structure for its Board of Directors. As part of this process, the company’s CEOHarpreet Singh , Ph.D., has joined the Board. Friedrich von Bohlen und Halbach, Ph.D., was appointed as successor ofChristof Hettich , L.L.D. Dr.von Bohlen und Halbach is Managing Partner and co-founder of dieviniHopp BioTech Holding , managing the investments ofDietmar Hopp and family.
Second Quarter 2021 Financial Results
Cash Position: Cash and cash equivalents as well as Other financial assets total €192.8 million (
Revenue: Total revenue, consisting of revenue from collaboration agreements, was €5.2 million (
Research and Development Expenses: R&D expenses were €20.3 million (
General and Administrative Expenses: G&A expenses were €8.3 million (
Net Loss: Net loss was €23.8 million (
Upcoming Investor Conferences
BTIG Virtual Biotechnology Conference –August 9-10, 2021 - Goldman Sachs London Biotech Symposium –
September 7, 2021 Jefferies London Healthcare Conference –November 16-18, 2021
To see the full list of events and presentations, visit www.investors.immatics.com/events-presentations.
Full financial statements can be found in the current report on Form 6-K filed with the
1 All amounts translated using the exchange rate published by the
2 in
About ACTengine® IMA200 series
Each of the product candidates of the IMA200 series is based on Immatics’ proprietary ACTengine® approach in which the patient’s own T cells are genetically engineered to express a novel, proprietary TCR directed against a defined cancer target. The modified T cells are then reinfused into the patient to attack the tumor, an approach also known as TCR-T. ACTengine® programs IMA201, IMA202 and IMA203 are currently in clinical development for the treatment of solid tumor indications, both in the US and in
The ACTengine® T cell products are manufactured at the
About TCER®
Immatics’ TCER® molecules are antibody-like “off-the-shelf” biologics that leverage the body’s immune system by redirecting and activating T cells towards cancer cells expressing a specific tumor target. To do so, the proprietary biologics are engineered to have two binding regions. The first region contains an affinity- and stability-improved TCR that binds specifically to the cancer target on the cell surface presented by a human leukocyte antigen (HLA) molecule. The second region is derived from an antibody domain that recruits endogenous T cells to the tumor to become activated. The design of the TCER® molecules enables the activation of any T cell in the body to attack the tumor, regardless of the T cells’ intrinsic specificity. In addition, the TCER® molecule has a Fc-part conferring stability, half-life extension and enhanced manufacturability.
About
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
For more information, please contact:
For Media Inquiries | Investor Relations Contact |
Phone: +49 89 2388 7731 | Phone: +1 646 791 9729 or +1 617-429-3548 |
immatics@trophic.eu | egoldstein@lifesciadvisors.com or jmullaly@lifesciadvisors.com |
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
As of | ||||
(Euros in thousands) | ||||
Assets | ||||
Current assets | ||||
Cash and cash equivalents | 160,093 | 207,530 | ||
Other financial assets | 32,712 | 24,448 | ||
Accounts receivable | 718 | 1,250 | ||
Other current assets | 4,815 | 5,763 | ||
Total current assets | 198,338 | 238,991 | ||
Non-current assets | ||||
Property, plant and equipment | 8,747 | 7,868 | ||
Intangible assets | 1,262 | 914 | ||
Right-of-use assets | 7,313 | 6,149 | ||
Other non-current assets | 845 | 724 | ||
Total non-current assets | 18,167 | 15,655 | ||
Total assets | 216,505 | 254,646 | ||
Liabilities and shareholders' deficit | ||||
Current liabilities | ||||
Provisions | 1,960 | 51 | ||
Accounts payable | 9,407 | 10,052 | ||
Deferred revenue | 57,998 | 46,600 | ||
Lease liabilities | 2,321 | 1,881 | ||
Other current liabilities | 1,442 | 2.025 | ||
Total current liabilities | 73,128 | 60,609 | ||
Non-current liabilities | ||||
Deferred revenue | 62,201 | 85,475 | ||
Lease liabilities | 4,736 | 4,306 | ||
Total non-current liabilities | 66,937 | 89,781 | ||
Shareholders' equity | ||||
Share capital | 629 | 629 | ||
Share premium | 589,609 | 573,339 | ||
Accumulated deficit | (507,663) | (462,253) | ||
Other reserves | (6,135) | (7,459) | ||
Total shareholders' equity | 76,440 | 104,256 | ||
Total liabilities and shareholders' equity | 216,505 | 254,646 |
Unaudited Condensed Consolidated Statement of Loss of
Three months ended | Six months ended | |||||||
2021 | 2020 | 2021 | 2020 | |||||
(Euros in thousands, except share and per share data) | (Euros in thousands, except share and per share data) | |||||||
Revenue from collaboration agreements | 5,189 | 6,896 | 12,592 | 13,936 | ||||
Research and development expenses | (20,340) | (16,505) | (43,389) | (28,751) | ||||
General and administrative expenses | (8,271) | (10,076) | (16,702) | (16,264) | ||||
Other income | 26 | 86 | 265 | 200 | ||||
Operating result | (23,396) | (19,599) | (47,234) | (30,879) | ||||
Financial income | 213 | 437 | 3,101 | 1,083 | ||||
Financial expenses | (629) | (2,164) | (1,277) | (110) | ||||
Financial result | (416) | (1,727) | 1,824 | 973 | ||||
Loss before taxes | (23,812) | (21,326) | (45,410) | (29,906) | ||||
Taxes on income | - | - | - | - | ||||
Net loss | (23,812) | (21,326) | (45,410) | (29,906) | ||||
Attributable to: | ||||||||
Equity holders of the parent | (23,812) | (21,043) | (45,410) | (29,349) | ||||
Non-controlling interest | - | (283) | - | (557) | ||||
Net loss | (23,812) | (21,326) | (45,410) | (29,906) | ||||
Net loss per share - basic and diluted | (0.38) | (0.64) | (0.72) | (0.89) | ||||
Weighted average shares outstanding - basic and diluted | 62,909,095 | 33,093,838 | 62,908,945 | 33,093,838 |
Unaudited Condensed Consolidated Statement of Comprehensive Loss of
Three months ended | Six months ended | ||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||
(Euros in thousands) | (Euros in thousands) | ||||||||||
Net Loss | (23,812) | (21,326) | (45,410) | (29,906) | |||||||
Other comprehensive loss | |||||||||||
Items that may be reclassified subsequently to profit or loss, net of tax | - | - | - | - | |||||||
Currency translation differences from foreign operations | (1,401) | 791 | 1,324 | 99 | |||||||
Total comprehensive loss for the period | (25,213) | (20,535) | (44,086) | (29,807) | |||||||
Attributable to: | |||||||||||
Equity holders of the parent | (25,213) | (20,252) | (44,086) | (29,250) | |||||||
Non-controlling interest | - | (283) | - | (557) | |||||||
Total comprehensive loss for the period | (25,213) | (20,535) | (44,086) | (29,807) | |||||||
Unaudited Condensed Consolidated Statement of Cash Flows of
Six months ended | |||
2021 | 2020 | ||
(Euros in thousands) | |||
Cash flows from operating activities | |||
Loss before taxation | (45,410) | (29,906) | |
Adjustments for: | |||
Interest income | (87) | (755) | |
Depreciation and amortization | 2,264 | 2,288 | |
Interest expense | 140 | 110 | |
Equity settled share-based payment | 16,270 | 6,928 | |
MD Anderson compensation expense | - | 45 | |
Increase in other liabilities resulting from share appreciation rights | - | 7,773 | |
Cash-out related to share-based compensation previously classified as equity-settled | - | (4,322) | |
Net foreign exchange differences | 236 | 1 | |
Changes in working capital | |||
Decrease in accounts receivable | 532 | 530 | |
Decrease/(increase) in other assets | 902 | (1,106) | |
Increase in accounts payable and other current liabilities | (11,363) | (9,724) | |
Interest received | 54 | 510 | |
Interest paid | (140) | (110) | |
Net cash used in operating activities | (36,602) | (27,738) | |
Cash flows from investing activities | |||
Payments for property, plant and equipment | (1,912) | (4,514) | |
Cash paid for investments classified in Other financial assets | (53,782) | (32,859) | |
Cash received from maturity of investments classified in Other financial assets | 45,770 | 48,881 | |
Payments for intangible assets | (390) | (36) | |
Proceeds from disposal of property, plant and equipment | 8 | - | |
Net cash (used in)/provided by investing activities | (10,306) | 11,472 | |
Cash flows from financing activities | |||
Payments for leases | (1,348) | (1,168) | |
Net cash used in financing activities | (1,348) | (1,168) | |
Net decrease in cash and cash equivalents | (48,256) | (17,434) | |
Cash and cash equivalents at beginning of period | 207,530 | 103,353 | |
Effects of exchange rate changes on cash and cash equivalents | 819 | 137 | |
Cash and cash equivalents at end of period | 160,093 | 86,056 |
Unaudited Condensed Consolidated Statement of Changes in Shareholders’ equity (deficit) of
(Euros in thousands) | Share capital | Share premium | Accumulated deficit | Other reserves | Total equity (deficit) attributable to shareholders of the parent | Non-controlling interest | Total share-holders' equity (deficit) | ||||||||||||||||||||||||||||
Balance as of | 1,164 | 190,945 | (233,194) | (770) | (41,855) | 1,020 | (40,835) | ||||||||||||||||||||||||||||
Other comprehensive loss | - | - | - | 99 | 99 | - | 99 | ||||||||||||||||||||||||||||
Net loss | - | - | (29,349) | - | (29,349) | (557) | (29,906) | ||||||||||||||||||||||||||||
Comprehensive loss for the year | - | - | (29,349) | 99 | (29,250) | (557) | (29,807) | ||||||||||||||||||||||||||||
Equity-settled share-based compensation | - | 6,928 | - | - | 6,928 | - | 6,928 | ||||||||||||||||||||||||||||
Cash-out related to share-based compensation previously classified as equity-settled | - | (4,322) | - | - | (4,322) | - | (4,322) | ||||||||||||||||||||||||||||
MD Anderson milestone compensation expense | - | - | - | - | - | 45 | 45 | ||||||||||||||||||||||||||||
Balance as of | 1,164 | 193,551 | (262,543) | (671) | (68,499) | 508 | (67,991) | ||||||||||||||||||||||||||||
Balance as of | 629 | 573,339 | (462,253) | (7,459) | 104,256 | - | 104,256 | ||||||||||||||||||||||||||||
Other comprehensive income | - | - | - | 1,324 | 1,324 | - | 1,324 | ||||||||||||||||||||||||||||
Net loss | - | - | (45,410) | - | (45,410) | - | (45,410) | ||||||||||||||||||||||||||||
Comprehensive income/(loss) for the year | - | - | (45,410) | 1,324 | (44,086) | (44,086) | |||||||||||||||||||||||||||||
Equity-settled share-based compensation | - | 16,270 | - | - | 16,270 | - | 16,270 | ||||||||||||||||||||||||||||
Balance as of | 629 | 589,609 | (507,663) | (6,135) | 76,440 | - | 76,440 |
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