Full Press Release Details
Immatics Announces Full Year 2023 Financial Results
and Corporate Update
Texas and Tuebingen, Germany, March 21, 2024 - 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 a business update and reported financial results for the
quarter and full year ended December 31, 2023.
kicked off 2024 with a successful capital raise, providing significant financial runway and additional momentum to advance our ongoing
clinical cell therapy and bispecific trials," said Harpreet Singh, Ph.D., CEO and Co-Founder of Immatics. "We are striving
to reach multiple relevant milestones this year, including announcing clinical proof-of-concept for our half-life
All amounts translated using the exchange rate published by the European Central Bank in effect
as of December 31, 2023 (1 EUR = 1.105 USD).
extended TCR Bispecifics
platform. In parallel, the clinical data for our PRAME cell therapy, IMA203 GEN1, in conjunction with highly constructive FDA discussions,
reinforces our confidence in advancing this asset toward a registration-enabling Phase 2/3 clinical trial in melanoma, while laying the
groundwork to transition into a fully equipped commercial-stage company."
and Subsequent Company Progress
Clinical development
plan update for ACTengine IMA203 GEN1 and IMA203CD8 GEN2 monotherapies
designation in October 2023 and productive interactions with the FDA, Immatics plans to initiate a registration-enabling randomized
Phase 2/3 trial in 2024 for IMA203 GEN1 in patients with second-line or later (2L+) cutaneous melanoma, potentially including also uveal
intends to assess IMA203 GEN1 targeting PRAME in HLA-A*02:01-positive cutaneous melanoma patients versus a control arm. This
single trial will be designed to support accelerated approval based on an interim readout and full approval based on overall survival.
The high prevalence of PRAME ( 95%) in cutaneous melanoma may enable the company to enroll patients without PRAME pre-testing. This
would enhance trial operations and could remove the need to develop a companion diagnostic in this indication. The full trial design
is currently being developed and is subject to further alignment with the FDA as part of the ongoing discussions. The Phase 2/3 trial
is planned to start in 2024.
Immatics cleared dose level 4a (DL4a, up to ~1.6x109 TCR-T cells) in December 2023, which is currently intended to be the
target dose for further development. In addition to treating melanoma patients, Immatics has also started to expand its clinical footprint
outside of melanoma to address a broader patient population with a particular focus on ovarian and uterine cancers.
for both Phase 1b cohorts with IMA203 GEN1 and IMA203CD8 GEN2 is planned for 2H 2024.
late-stage clinical cell therapy development is supported by its streamlined manufacturing timeline, capabilities and facility. IMA203
GEN1 and IMA203CD8 GEN2 cell therapy products are manufactured within 7 days followed by a 7-day QC release testing at a success rate
of >95% to reach the target dose (IMA203 GEN1: RP2D; IMA203CD8: DL4a). The company has also recently completed construction of a ~100,000
square foot R&D and GMP manufacturing facility with a modular design for efficient and cost-effective scalability to serve early-stage
and registration-enabling clinical trials, as well as potential initial commercial supply.
data update on ACTengine IMA203 GEN1 and IMA203CD8 GEN2 monotherapies, as of November 2023
On November 8, 2023,
Immatics provided an interim clinical update from the ongoing Phase 1 trial with ACTengine
IMA203 targeting PRAME in patients with recurrent and/or refractory solid cancers (data cut-off September 30, 2023). The update
was focused on IMA203 GEN1 in melanoma patients at the recommended Phase 2 dose (RP2D, 1.0-10x109 total TCR-T cells) and the
first clinical data for IMA203CD8 GEN2.
Treatment with IMA203
GEN1 monotherapy (consisting of PRAME-specific functional CD8+ cells) in Phase 1a and Phase 1b Cohort A at RP2D demonstrated durable
objective responses in melanoma patients with one patient exceeding 12 months and two patients exceeding 15 months post infusion and
a 50% (6/12) confirmed objective response rate (cORR). Median duration of response (mDOR) was not reached (min 2.2+ months, max 14.7+
months) at a median follow-up (mFU) of 14.4 months. In line with previous results, IMA203 GEN1 monotherapy was well tolerated at total
doses of up to 10x109 TCR-T cells infused.
first data on the company's second-generation product candidate IMA203CD8 (consisting of PRAME-specific functional CD8+ and CD4+
cells) demonstrated 56% (5/9) cORR with enhanced pharmacology compared to IMA203 GEN1. mDOR was not reached (min 2.0+ months, max 11.5+
months) at a mFU of 4.8 months. As of the reported cut-off date, IMA203CD8 GEN2 exhibited a manageable tolerability profile.
T cell engaging receptor (TCER ) candidates are next-generation, half-life extended TCR Bispecific molecules. They are
designed to achieve a patient-convenient dosing schedule and to maximize efficacy while minimizing toxicities in patients through the
proprietary format using a high-affinity TCR domain against the tumor target and a low-affinity T cell recruiter binding to the T cell.
for Immatics' clinical TCER pipeline
deliver clinical proof-of-concept for its novel TCER platform as quickly as possible and plans to provide first clinical
data for IMA401 (MAGEA4/8) and IMA402 (PRAME) in 2H 2024.
Key objectives include:
across multiple solid cancers, but initially focused on melanoma, is anticipated to be announced in 2H 2024.
Corporate Development
Cash and cash equivalents as well as other financial assets total 425.9 million ($470.6 million1) as of December
31, 2023, compared to 362.2 million ($400.2 million1) as of December 31, 2022. The increase is mainly due to upfront
payments for collaborations, partly offset by our ongoing research and development activities. This does not include the net
in January 2024 from the public offering. Adding these proceeds, the company currently projects a cash runway into 2027.
Total revenue, consisting of revenue from collaboration agreements, was 54.0 million ($59.7 million1) for the year ended
December 31, 2023, compared to 172.8 million ($190.9 million1) for the year ended December 31, 2022. The decrease is
mainly the result of a one-time revenue for the license portion of the IMA401 collaboration with Bristol Myers Squibb for the year
ended December 31, 2022.
Development Expenses: R&D expenses were 118.7 million ($131.2 million1) for the year ended December 31, 2023,
compared to 106.8 million ($118.0 million1) for the year ended December 31, 2022. The increase mainly resulted from
costs associated with the advancement of the clinical pipeline of ACTengine and TCER candidates.
General and Administrative
Expenses: G&A expenses were 38.2 million ($42.2 million1) for the year ended December 31, 2023, compared to
36.1 million ($39.9 million1) for the year ended December 31, 2022.
Loss: Net loss was 97.0 million ($107.2 million1) for the year ended December 31, 2023, compared to a net profit
of 37.5 million ($41.4 million1) for the year ended December 31, 2022. The decrease of net profit resulted mainly from
the one-time license fee income in connection with the IMA401 collaboration with Bristol Myers Squibb, as well as the recognition of
remaining deferred revenue in connection with the termination of the GSK collaboration for the year ended December 31, 2022.
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
list of events and presentations, visit www.investors.immatics.com/events-presentations.
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.
intends to use its website www.immatics.com as a means of disclosing material non-public information.
statements in this press release may be considered forward-looking statements. Forward-looking statements generally relate to future
events or the Company's future financial or operating performance. For example, statements concerning timing of data read-outs
for product candidates, the timing and outcome of clinical trials, the nature of clinical trials (including whether such clinical trials
will be registration-enabling), the timing of IND or CTA filing for pre-clinical stage product candidates, estimated market opportunities
of product candidates, the Company's focus on partnerships to advance its strategy, and other metrics are forward-looking statements.
In some cases, you can identify forward-looking statements by terminology such as "may", "should", "expect",
"plan", "target", "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, 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 the Company's Annual report
on Form 20-F and other filings with the Securities and Exchange Commission (SEC). Nothing in this press release should be regarded as