On May 18, 2021 Immatics N.V. (NASDAQ: IMTX; "Immatics"), a clinical-stage biopharmaceutical company active in the discovery and development of T cell redirecting cancer immunotherapies, reported financial results and provided a business update for the quarter ended March 31, 2021 (Press release, Immatics, MAY 18, 2021, View Source [SID1234580204]).

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"In the first quarter of 2021, we reported first anti-tumor activity at the initial dose levels of our ACTengine IMA200 clinical trial series which indicates the potential of our engineered Adoptive Cell Therapy approach. We continue to scale up enrollment by initiating additional trial sites in the US and Europe – and now look forward to treating patients at target dose levels and provide a next update in the second half of 2021," said Harpreet Singh, Ph.D., CEO of Immatics. "In addition, we are on track with our first clinical trial application for TCER towards the end of this year. By engaging two therapeutic modalities, Adoptive Cell Therapy and TCR Bispecifics, we are aiming to address a broad cancer patient population with an urgent need for new therapeutic options."

First Quarter 2021 and Subsequent Company Progress

Adoptive Cell Therapy Programs

ACTengine IMA200 series – Immatics provided a clinical data update from three ongoing ACTengine Phase 1 trials for its engineered Adoptive Cell Therapy approach (also known as TCR-T) in March. The combined data readout during early phases of dose escalation for the ACTengine programs, IMA201, IMA202 and IMA203, indicated first anti-tumor activity with tumor shrinkage observed in 8 out of 10 patients including one unconfirmed partial response as of data cut-off. This was consistent with the observed robust engraftment, persistence and tumor infiltration of infused ACTengine T cells. Overall, the product candidates demonstrated a manageable safety and tolerability profile.
The ACTengine trials continue to recruit according to plan with eight trial sites active in both Europe and the US. A data update is expected in H2 2021 with additional patients being treated, including initial data from patients treated at the target dose.
The fourth program of the ACTengine IMA200 series, IMA204, is directed at the novel tumor stroma target COL6A3 exon 6 expressed in a large variety of solid cancers. IMA204 is utilizing a next-generation CD8-independent T cell receptor. Following a scientific advice meeting2 with Paul-Ehrlich-Institute (PEI) in May, the Federal German regulatory authority, submission of a clinical trial application (CTA) remains on track for Q4 2021.

TCR Bispecifics Programs

IMA402 – Immatics provided preclinical proof-of-concept data for its second TCER program, IMA402, at the Annual PEGS Boston Protein Engineering and Cell Therapy Summit in May. The IMA402 candidate targets an Immatics-validated peptide derived from PRAME, a protein that is frequently expressed in many solid cancers, thereby supporting the program’s potential to address a broad cancer patient population. IMA402 demonstrated tumor cell killing in vitro and lead to consistent tumor reduction including complete regression of established tumors in an in vivo mouse model. Immatics has selected a clinical lead candidate for the IMA402 program and initiated manufacturing activities to advance this program towards the Investigational New Drug (IND) stage and clinical development.
The company’s first TCER program, IMA401 remains on track for submission of a clinical trial application (CTA) by year end 2021. The company had announced preclinical proof-of-concept data for IMA401 in last quarter of 2020.
First Quarter 2021 Financial Results

Cash Position: Cash and cash equivalents as well as other financial assets total €216.7 million ($254.0 million1) as of March 31, 2021. compared to €232.0 million ($272.0 million1) as of December 31, 2020.

Revenue: Total revenue, consisting of revenue from collaboration agreements, was €7.4 million ($8.7 million1) for the three months ended March 31, 2021, compared to €7.0 million ($8.2 million1) for the three months ended March 31, 2020.

Research and Development Expenses: R&D expenses were €23.0 million ($27.0 million1) for the three months ended March 31, 2021, compared to €12.2 million ($14.4 million1) for the three months ended March 31, 2020. The increase is mainly due to increased share-based compensation (€4.5 million; $5.3 million1) as well as higher operating expenses due to increased clinical and manufacturing activities.

General and Administrative Expenses: G&A expenses were €8.4 million ($9.9 million1) for the three months ended March 31, 2021, compared to €6.2 million ($7.3 million1) for the three months ended March 31, 2020. The increase is mainly due to increased share-based compensation (€3.1 million; $3.7 million1), partly offset by one-time transaction costs of the NASDAQ listing in connection with the ARYA merger in July 2020.

Net Loss: Net loss was €21.6 million ($25.3 million1) for the three months ended March 31, 2021, compared to €8.6 million ($10.1 million1) for the three months ended March 31, 2020.

Upcoming Investor Conferences

Jefferies Virtual Healthcare Conference – June 1-3, 2021
Goldman Sachs 42nd Annual Global Healthcare Conference – June 8-11, 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 View Source

1 All amounts translated using the exchange rate published by the European Central Bank in effect as of March 31, 2021 (1 EUR = 1.1725 USD).
2 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).

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.