- 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, Germany and Houston, TX, August 10, 2021 – 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 its financial results for the quarter ended June 30, 2021 and provided a business update on its progress over the reporting period.
“An important development during the second quarter of 2021 was a significant increase in patient enrollment for our ACTengine® programs,” said Harpreet Singh, Ph.D., CEO of Immatics. “Following the positive initial results we provided in the first quarter, we now look forward to announcing more advanced data including safety, biological activity and the assessment of anti-tumor activity for a range of different cancer indications in the second half of 2021.”
“In addition to the upcoming clinical data for our ACTengine® trials, we are excited to move our second therapeutic modality towards the clinic,” added Carsten Reinhardt, M.D., Ph.D., Chief Development Officer at Immatics. “We are encouraged by the entirety of the IMA401 data set, which following discussions with regulatory authorities puts us in a strong position to submit our IMA401 Clinical Trial Application during the fourth quarter of 2021. Our TCER® pipeline is further strengthened by our second TCR Bispecifics program, IMA402, for which we recently presented preclinical proof-of-concept data.”
Second Quarter 2021 and Subsequent Company Progress
- 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.
- 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 the Paul-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.
- As of July 1, 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., has joined the Board.
- Friedrich von Bohlen und Halbach, Ph.D., was appointed as successor of Christof Hettich, L.L.D. Dr. von Bohlen und Halbach is Managing Partner and co-founder of dievini Hopp BioTech Holding, managing the investments of Dietmar Hopp and family.
Second Quarter 2021 Financial Results
Cash Position: Cash and cash equivalents as well as Other financial assets total €192.8 million ($229.1 million1) as of June 30, 2021, compared to €216.7 million ($257.5 million1) as of March 31, 2021.
Revenue: Total revenue, consisting of revenue from collaboration agreements, was €5.2 million ($6.2 million1) for the three months ended June 30, 2021, compared to €6.9 million ($8.2 million1) for the three months ended June 30, 2020.
Research and Development Expenses: R&D expenses were €20.3 million ($24.1 million1) for the three months ended June 30, 2021, compared to €16.5 million ($19.7 million1) for the three months ended June 30, 2020. The increase is mainly due to expanded clinical activities for the ACTengine® IMA200 series, as well as GMP manufacturing for the TCER® compound, IMA401.
General and Administrative Expenses: G&A expenses were €8.3 million ($9.9 million1) for the three months ended June 30, 2021, compared to €10.1 million ($12.0 million1) for the three months ended June 30, 2020. The decrease is mainly due to one-time expenses in connection with the listing of the Company in 2020.
Net Loss: Net loss was €23.8 million ($28.3 million1) for the three months ended June 30, 2021, compared to €21.3 million ($25.3 million1) for the three months ended June 30, 2020.
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 Securities and Exchange Commission (SEC) and published on the SEC website under www.sec.gov.
1 All amounts translated using the exchange rate published by the European Central Bank in effect as of June 30, 2021 (1 EUR = 1.1884 USD).
2 in Europe, equivalent to a pre-IND meeting at FDA.
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 Germany. All ACTengine® product candidates can be rapidly manufactured utilizing a proprietary manufacturing process designed to enhance T cell engraftment and persistence in vivo.
The ACTengine® T cell products are manufactured at the Evelyn H. Griffin Stem Cell Therapeutics Research Laboratory in collaboration with UTHealth and co-funded by the Cancer Prevention and Research Institute of Texas (CPRIT).
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.
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.
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:
|For Media Inquiries||Investor Relations Contact|
|Jacob Verghese or Stephanie May||Eric Goldstein or John Mullaly|
|Trophic Communications||LifeSci Advisors|
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Unaudited Condensed Consolidated Statement of Financial Position of Immatics N.V.
|June 30, 2021||December 31, 2020|
|(Euros in thousands)|
|Cash and cash equivalents||160,093||207,530|
|Other financial assets||32,712||24,448|
|Other current assets||4,815||5,763|
|Total current assets||198,338||238,991|
|Property, plant and equipment||8,747||7,868|
|Other non-current assets||845||724|
|Total non-current assets||18,167||15,655|
|Liabilities and shareholders' deficit|
|Other current liabilities||1,442||2.025|
|Total current liabilities||73,128||60,609|
|Total non-current liabilities||66,937||89,781|
|Total shareholders' equity||76,440||104,256|
|Total liabilities and shareholders' equity||216,505||254,646|
Unaudited Condensed Consolidated Statement of Loss of Immatics N.V.
|Three months ended June 30,||Six months ended June 30,|
|(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)|
|Loss before taxes||(23,812)||(21,326)||(45,410)||(29,906)|
|Taxes on income||-||-||-||-|
|Equity holders of the parent||(23,812)||(21,043)||(45,410)||(29,349)|
|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 Immatics N.V.
|Three months ended June 30,||Six months ended June 30,|
|(Euros in thousands)||(Euros in thousands)|
|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)|
|Equity holders of the parent||(25,213)||(20,252)||(44,086)||(29,250)|
|Total comprehensive loss for the period||(25,213)||(20,535)||(44,086)||(29,807)|
Unaudited Condensed Consolidated Statement of Cash Flows of Immatics N.V.
|Six months ended June 30,|
|(Euros in thousands)|
|Cash flows from operating activities|
|Loss before taxation||(45,410)||(29,906)|
|Depreciation and amortization||2,264||2,288|
|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)|
|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 Immatics N.V.
|(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 January 1, 2020||1,164||190,945||(233,194)||(770)||(41,855)||1,020||(40,835)|
|Other comprehensive loss||-||-||-||99||99||-||99|
|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 June 30, 2020||1,164||193,551||(262,543)||(671)||(68,499)||508||(67,991)|
|Balance as of January 1, 2021||629||573,339||(462,253)||(7,459)||104,256||-||104,256|
|Other comprehensive income||-||-||-||1,324||1,324||-||1,324|
|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 June 30, 2021||629||589,609||(507,663)||(6,135)||76,440||-||76,440|