Company Provides Clinical Data Update from Ongoing Phase 1 Clinical Trial with
ACTengine® IMA203 TCR-T Targeting PRAME
* Updated clinical data on ACTengine® IMA203 targeting PRAME in 30 heavily
pre-treated metastatic melanoma patients at RP2D: 55% confirmed objective
response rate, including tumor shrinkage achieved in 87% of patients; median
duration of response of 13.5 months including 11/16 ongoing confirmed
responses; IMA203 continues to maintain a favorable safety profile
* Registration-enabling randomized Phase 2/3 trial for ACTengine® IMA203 in
2L+ melanoma planned to commence in 2024 following further discussions with
FDA
* Next data update on IMA203 and IMA203CD8 (GEN2) planned for 2H 2024
* First clinical data updates for Immatics' next-generation, half-life
extended TCR Bispecifics, TCER® IMA401 (MAGEA4/8) and TCER® IMA402 (PRAME),
from ongoing Phase 1 dose escalation trials planned for 2H 2024; updates to
include details on safety, pharmacokinetics and initial anti-tumor activity
* $201.5 million public offering completed on January 22, 2024
* Cash and cash equivalents, as well as other financial assets, amount to
$609.7 million(1) (EUR564.0 million) as of March 31, 2024 funding company
operations into 2027
Houston, Texas and Tuebingen, Germany, May 14, 2024 - Immatics N.V.
(https://immatics.com/) (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 ended March 31, 2024.
"Our lead cell therapy candidate, IMA203, continues to show deep and durable
responses in a significantly expanded data set since our last data readout in
November 2023. This update emphasizes the meaningful impact our novel
immunotherapy may have on the lives of metastatic cutaneous, uveal and mucosal
melanoma patients and the medical needs that IMA203 has a real opportunity to
address. We continue to plan to move IMA203 into a registration-enabling
clinical trial within this year while also continuing to ramp up our commercial
manufacturing buildout," said Harpreet Singh, Ph.D., CEO and Co-Founder of
Immatics. "In addition to IMA203's progress, we also look forward to presenting
the first clinical data on the two lead candidates from our bispecifics pipeline
in the second half of the year."
First Quarter 2024 and Subsequent Company Progress
ACTengine® Cell Therapy Program (https://immatics.com/adoptive-cell-therapies/)
ACTengine® IMA203 monotherapy
Today, Immatics is providing a data update on IMA203 monotherapy targeting PRAME
from the ongoing Phase 1 trial at the recommended Phase 2 dose (RP2D, 1 to 10
billion total TCR-T cells) in 30 heavily pretreated metastatic melanoma patients
evaluable for efficacy. The treated patient population is composed of patients
with a median of 3 lines of prior systemic treatments, consisting of cutaneous
melanoma patients (N=17), uveal melanoma patients (N=10), mucosal melanoma
patients (N=2) and a patient with melanoma of unknown primary (N=1). The current
data represent an update to the previously communicated interim data readout in
the IMA203 melanoma efficacy population of November 8, 2023
(https://investors.immatics.com/news-releases/news-release-details/immatics-
reports-interim-clinical-data-actenginer-ima203-and).
As of the data cut-off on April 25, 2024, treatment with IMA203 monotherapy in
the efficacy population has demonstrated:
* Confirmed objective response rate (cORR) of 55% (16/29)
* Disease control rate of 90% (27/30)
* Tumor shrinkage in 87% (26/30) of patients
* Median duration of response (mDOR) was 13.5 months (min 1.2+, max 21.5+
months) including 11 of 16 confirmed objective responses ongoing at data
cut-off and longest duration of response ongoing at >21 months after
infusion
* Confirmed response rates are similar across all melanoma subtypes (56%
(9/16) in cutaneous melanoma; 54% (7/13) in other melanoma subtypes)
To date, IMA203 has maintained a favorable safety profile with no treatment-
related grade 5 events in the safety population (N=65 patients across all dose
levels and all tumor types).
Best overall response for IMA203 at RP2D in melanoma
More information and details on the IMA203 clinical data update in melanoma are
available in the Immatics corporate presentation:
https://investors.immatics.com/events-presentations
The next data update with translational and clinical data for IMA203 is planned
for 2H 2024 at a medical conference.
Immatics' late-stage clinical cell therapy development is supported by its
differentiated manufacturing related to timeline, capabilities and facilities.
ACTengine® IMA203 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. 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 intended to serve early-stage and Phase 2/3 clinical
trials, as well as initial commercial supply. The new site will start GMP
manufacturing of cell therapy products in early 2025. Meanwhile, the existing
GMP facility, which is run in collaboration with UT Health, will remain active
until YE 2025 and will also initially serve the Phase 2/3 registrational trial.
Following an RMAT designation in October 2023
(https://investors.immatics.com/news-releases/news-release-details/immatics-
receives-fda-regenerative-medicine-advanced-therapy-0) and productive
interactions with the FDA, Immatics plans to initiate a randomized Phase 2/3
trial in 4Q 2024 for IMA203 in patients with second-line or later (2L+)
cutaneous melanoma, potentially also including uveal melanoma patients.
The Phase 2/3 trial is expected to assess IMA203 targeting PRAME in HLA-A*02:01-
positive cutaneous melanoma patients versus a control arm. This approach is
consistent with the FDA's "one-trial" approach(2), i.e., a single randomized
controlled trial to support accelerated approval and the verification of
clinical benefit to achieve full approval. 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 would remove the need to
develop a companion diagnostic for PRAME testing 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. Further details of the final
clinical trial design will be provided in 2H 2024.
IMA203 is being developed to treat patients with metastatic melanoma, a
prevalent cancer type with increasing incidence both inside and outside the
United States. Currently, eligible PRAME-positive melanoma patients for the
ongoing trials, i.e., 2L+, HLA-A*02:01 positive, include -3,000 cutaneous
melanoma patients and -300 eligible uveal melanoma patients(3) in the US.
ACTengine® IMA203CD8 (GEN2) monotherapy
As of the previously reported interim clinical update from November 8,
(https://investors.immatics.com/news-releases/news-release-details/immatics-
reports-interim-clinical-data-actenginer-ima203-and) 2023, the 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. mDOR was not reached (min 2.0+ months,
max 11.5+ months) at a mFU of 4.8 months. As of the reported September
30, 2023, cut-off date, IMA203CD8 (GEN2) exhibited a manageable tolerability
profile.
For IMA203CD8 (GEN2), Immatics cleared dose level 4a (DL4a, up to -1.6x10(9)
TCR-T cells) in December 2023. Immatics plans to continue dose escalation with
the goal to define the optimal 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.
A next data update for IMA203CD8 (GEN2) is planned for 2H 2024.
TCR Bispecifics Programs (https://immatics.com/tcr-bispecifics/)
Immatics' 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.
Upcoming milestones for Immatics' clinical TCER® pipeline
Immatics seeks to 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:
* Demonstrating tolerability of the novel, next-generation, half-life extended
TCR Bispecifics format;
* Optimizing dosing schedule to a less frequent regimen during dose escalation
based on pharmacokinetics data;
* Demonstrating initial clinical anti-tumor activity (i.e., confirmed
objective responses according to RECIST 1.1).
TCER® IMA401 (MAGEA4/8)
The Phase 1 dose escalation basket trial to evaluate safety, tolerability and
initial anti-tumor activity of TCER® IMA401 in patients with recurrent and/or
refractory solid tumors is ongoing. IMA401 targets an HLA-A*02:01-presented
peptide that occurs identically in two different proteins, MAGEA4 and MAGEA8.
This target peptide has been selected based on natural expression in native
solid tumors at particularly high target density (peptide copy number per tumor
cell identified by Immatics' proprietary quantitative mass spectrometry engine
XPRESIDENT® is >5x higher than for a MAGEA4 peptide target used in other
clinical trials).
MAGEA4 and MAGEA8 are expressed in multiple solid cancers, including lung
cancer, head and neck cancer, melanoma, ovarian cancer, sarcoma and others.
Tolerability continues to be manageable with transient low-grade CRS,
lymphopenia and neutropenia at high doses, all of which are expected for a
bispecific T cell engager. A premedication with low doses of dexamethasone
administered prior to the first 4 infusions, as used with other approved
bispecific products, has been implemented as a preventative measure for
continued dose escalation. Since the implementation of this premedication, to
date, no cases of high-grade neutropenia among the patients treated have been
observed. Based on pharmacokinetics data, the treatment schedule for IMA401 was
switched from weekly to bi-weekly dosing. Confirmed objective responses have
been observed in multiple patients.
IMA401 is being developed in collaboration with Bristol Myers Squibb. First
clinical data in at least 25 patients in dose escalation across all doses and
multiple solid cancers is expected to be announced in 2H 2024.
TCER® IMA402 (PRAME)
Immatics initiated the Phase 1/2 trial (https://investors.immatics.com/news-
releases/news-release-details/immatics-initiates-phase-12-clinical-trial-
evaluate-prame-tcr) investigating the company's fully owned TCER® candidate
IMA402 in patients with recurrent and/or refractory solid tumors in August 2023
and the first patients have been dosed. Initial focus indications are ovarian
cancer, lung cancer, uterine cancer and cutaneous and uveal melanoma, among
others. IMA402 targets an HLA-A*02:01-presented peptide derived from the tumor
antigen PRAME. This target peptide has been selected based on natural expression
in native solid primary tumors and metastases at particularly high target
density (peptide copy number per tumor cell identified by Immatics' proprietary
quantitative mass spectrometry engine XPRESIDENT®).
Immatics has recently engaged Patheon UK Limited, a subsidiary of ThermoFisher
Scientific Inc., for the manufacturing of clinical IMA402 batches for its use
within a potential registration-enabling trial. Patient recruitment and dose
escalation continue to scale. First clinical data in at least 15 patients in
dose escalation across multiple solid cancers, but initially focused on
melanoma, is anticipated to be announced in 2H 2024.
Corporate Development
* On January 22, 2024, Immatics completed an offering of 18,313,750 ordinary
shares at a public offering price of $11.00 per share. The gross proceeds
from the offering, before deducting the underwriting discount and offering
expenses, were approximately $201.5 million.
First Quarter 2024 Financial Results
Cash Position: Cash and cash equivalents, as well as other financial assets,
total EUR564.0 million ($609.7 million(1)) as of March 31, 2024, compared to
EUR425.9 million ($460.4 million(1)) as of December 31, 2023. The increase is
mainly due to the public offering in January 2024, partly offset by ongoing
research and development activities. The company projects a cash runway into
2027.
Revenue: Total revenue, consisting of revenue from collaboration agreements, was
EUR30.3 million ($32.8 million(1)) for the three months ended March 31, 2024,
compared to EUR9.8 million ($10.6 million(1)) for the three months ended March
31, 2023. The increase is mainly the result of the release of the deferred
revenue following the termination of the Genmab collaboration.
Research and Development Expenses: R&D expenses were EUR32.1 million ($34.7
million(1)) for the three months ended March 31, 2024, compared to EUR27.6 million
($29.8 million(1)) for the three months ended March 31, 2023. The increase
mainly resulted from costs associated with the advancement of the clinical
pipeline candidates.
General and Administrative Expenses: G&A expenses were EUR11.6 million ($12.5
million(1)) for the three months ended March 31, 2024, compared to EUR9.6 million
($10.4 million(1)) for the three months ended March 31, 2023.
Net Profit and Loss: Net loss was EUR3.1 million ($3.4 million(1)) for the three
months ended March 31, 2024, compared to a net loss of EUR19.7 million ($21.3
million(1)) for the three months ended March 31, 2023. The decrease of net loss
resulted mainly from the one-time revenue related to the termination of the
Genmab collaboration, as reported previously.
Full financial statements can be found in the 6-K filed with the Securities and
Exchange Commission (SEC) on May 14, 2024, and published on the SEC website
under www.sec.gov (https://www.sec.gov/).
Upcoming Investor Conferences
* Bank of America Health Care Conference, Las Vegas (NV) - May 14 - 16, 2024
* Jefferies Global Healthcare Conference, New York (NY) - June 5 - 7, 2024
To see the full list of events and presentations, visit
www.investors.immatics.com/events-presentations
(http://www.investors.immatics.com/events-presentations).
- END -
About IMA203 and target PRAME
ACTengine(®) IMA203 T cells are directed against an HLA-A*02-presented peptide
derived from preferentially expressed antigen in melanoma (PRAME), a protein
frequently expressed in a large variety of solid cancers, thereby supporting the
program's potential to address a broad cancer patient population. Immatics'
PRAME peptide is present at a high copy number per tumor cell and is
homogeneously and specifically expressed in tumor tissue. The peptide has been
identified and characterized by Immatics' proprietary mass spectrometry-based
target discovery platform, XPRESIDENT(®). Through its proprietary TCR discovery
and engineering platform XCEPTOR(®), Immatics has generated a highly specific T
cell receptor (TCR) against this target for its TCR-based cell therapy approach,
ACTengine(®) IMA203.
ACTengine(®) IMA203 TCR-T is currently being evaluated in Phase 1 IMA203
monotherapy, and IMA203CD8 (GEN2) monotherapy, where IMA203 engineered T cells
are co-transduced with a CD8?? co-receptor. As previously reported, IMA203 in
combination with an immune checkpoint inhibitor has been deprioritized.
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 (http://www.immatics.com)
as a means of disclosing material non-public information. For regular updates
you can also follow us on X (https://twitter.com/immatics), Instagram
(https://www.instagram.com/immatics/) and LinkedIn
(https://www.linkedin.com/company/immatics-biotechnologies/).
Forward-Looking Statements
Certain 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, outcome
and design 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 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 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 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. The Company undertakes no duty to update these
forward-looking statements. All the scientific and clinical data presented
within this press release are - by definition prior to completion of the
clinical trial and a clinical study report - preliminary in nature and subject
to further quality checks including customary source data verification.
For more information, please contact:
Media
Trophic Communications
Phone: +49 171 3512733
immatics@trophic.eu (mailto:immatics@trophic.eu)
Immatics N.V.
Jordan Silverstein
Head of Strategy
Phone: +1 346 319-3325
InvestorRelations@immatics.com (mailto:InvestorRelations@immatics.com)
Immatics N.V. and subsidiaries
Condensed Consolidated Statement of Loss of Immatics N.V.
Three months ended March 31,
2024 2023
(Euros in thousands, except
per share data)
Revenue from collaboration agreements 30,269 9,796
Research and development expenses (32,108) (27,581)
General and administrative expenses (11,642) (9,586)
Other income 12 941
Operating result (13,469) (26,430)
Change in fair value of liabilities for
warrants 1,043 7,397
Other financial income 11,381 2,795
Other financial expenses (677) (3,509)
Financial result 11,747 6,683
Loss before taxes (1,722) (19,747)
Taxes on income (1,332) -
Net loss (3,054) (19,747)
Net loss per share:
Basic (0.03) (0.26)
Diluted (0.04) (0.26)
Immatics N.V. and subsidiaries
Condensed Consolidated Statement of Comprehensive Loss of Immatics N.V.
Three months ended March
31,
2024 2023
(Euros in thousands)
Net loss (3,054) (19,747)
Other comprehensive income
Items that may be reclassified subsequently to
profit or loss
Currency translation differences from foreign
operations 336 564
Total comprehensive loss for the year (2,718) (19,183)
Immatics N.V. and subsidiaries
Condensed Consolidated Statement of Financial Position of Immatics N.V.
As of
March 31, December 31,
2024 2023
(Euros in thousands)
Assets
Current assets
Cash and cash equivalents 122,093 218,472
Other financial assets 441,857 207,423
Accounts receivables 1,781 4,093
Other current assets 22,666 19,382
Total current assets 588,397 449,370
Non-current assets
Property, plant and equipment 49,968 43,747
Intangible assets 1,501 1,523
Right-of-use assets 11,886 13,308
Other non-current assets 1,373 2,017
Total non-current assets 64,728 60,595
Total assets 653,125 509,965
Liabilities and shareholders' equity
Current liabilities
Provisions 1,740 -
Accounts payables 20,537 25,206
Deferred revenue 96,525 100,401
Liabilities for warrants 17,950 18,993
Lease liabilities 2,762 2,604
Other current liabilities 9,590 9,348
Total current liabilities 149,104 156,552
Non-current liabilities
Deferred revenue 91,358 115,527
Lease liabilities 11,877 12,798
Other non-current liabilities - 4
Total non-current liabilities 103,235 128,329
Shareholders' equity
Share capital 1,031 847
Share premium 1,001,402 823,166
Accumulated deficit (600,347) (597,293)
Other reserves (1,300) (1,636)
Total shareholders' equity 400,768 225,084
Total liabilities and shareholders' equity 653,125 509,965
Immatics N.V. and subsidiaries
Condensed Consolidated Statement of Cash Flows of Immatics N.V.
Three months ended March
31,
2024 2023
(Euros in thousands)
Cash flows from operating activities
Net profit/(loss) (3,054) (19,747)
Taxes on income 1,332 -
Profit/(loss) before tax (1,722) (19,747)
Adjustments for:
Interest income (6,294) (2,254)
Depreciation and amortization 3,014 1,811
Interest expenses 194 195
Equity-settled share-based payment 4,297 6,103
Net foreign exchange differences and expected
credit losses (4,553) 3,143
Change in fair value of liabilities for
warrants (1,043) (7,397)
Changes in:
Decrease/(increase) in accounts receivables 2,312 880
Decrease/(increase) in other assets 574 234
(Decrease)/increase in deferred revenue, accounts
payables and other liabilities (31,674) (7,793)
Interest received 2,484 1,189
Interest paid (194) (79)
Income tax paid - -
Net cash (used in)/provided by operating
activities (32,605) (23,715)
Cash flows from investing activities
Payments for property, plant and equipment (9,174) (4,317)
Payments for intangible assets (2) (8)
Proceeds from disposal of property, plant and
equipment - -
Payments for investments classified in Other
financial assets (290,599) (67,735)
Proceeds from maturity of investments classified in
Other financial assets 57,957 68,341
- -
Net cash (used i n)/provided by investing
activities (241,818) (3,719)
Cash flows from financing activities
Proceeds from issuance of shares to equity
holders 185,669 -
Transaction costs deducted from equity (11,548) -
Payments related to lease liabilities 524 (866)
Net cash provided by/(used in) financing
activities 174,645 (866)
Net (decrease)/increase in cash and cash
equivalents (99,778) (28,300)
Cash and cash equivalents at beginning of the
year 218,472 148,519
Effects of exchange rate changes and expected
credit losses on cash and cash equivalents 3,399 (2,300)
Cash and cash equivalents at end of the
year 122,093 117,919
Immatics N.V. and subsidiaries
Condensed Consolidated Statement of Changes in Shareholders' equity of Immatics
N.V.
Total
share-
Share Share Accumulated Other holders'
(Euros in thousands) capital premium deficit reserves equity
Balance as of January 1,
2023 767 714,177 (500,299) (1,481) 213,164
Other comprehensive
income - - - 564 564
Net loss - - (19,747) - (19,747)
Comprehensive loss for the
year - - (19,747) 564 (19,183)
Equity-settled share-based
compensation - 6,103 - - 6,103
Share options exercised
- - - - -
Issue of share capital - net
of transaction costs - - - - -
Balance as of March 31, 2023 767 720,280 (520,046) (917) 200,084
Balance as of January 1,
2024 847 823,166 (597,293) (1,636) 225,084
Other comprehensive income
- - - 336 336
Net loss - - (3,054) - (3,054)
Comprehensive loss for the
year - - (3,054) 336 (2,718)
Equity-settled share-based
compensation - 4,297 - - 4,297
Share options exercised
1 682 - - 683
Issue of share capital - net
of transaction costs 183 173,257 - - 173,440
Balance as of March 31, 2024 1,031 1,001,402 (600,347) (1,300) 400,786--------------------------------------------------------------------------------
(1) All amounts translated using the exchange rate published by the European
Central Bank in effect as of March 31, 2024 (1 EUR = 1.0811 USD).
(2) FDA Draft Guidance "Clinical Trial Considerations To Support Accelerated
Approval of Oncology Therapeutics - Guidance for Industry," March 2023
(3) Estimated 41% HLA-A*02:01 positive population in the US; PRAME target
prevalence is based on TCGA (for SCLC: in-house) RNAseq data combined with a
proprietary mass spec-guided RNA expression threshold; Uveal melanoma target
prevalence is based on IMADetect® qPCR testing of screening biopsies from
clinical trial patients (n=33)
Â