- Phase 1/2 clinical trial initiated
evaluating Immatics’ second next-generation half-life extended TCR
Bispecific program, TCER® IMA402 targeting PRAME
- ACTengine® IMA203 TCR-T monotherapy
against PRAME showed 67% confirmed ORR in an interim clinical
update on 11 heavily pre-treated patients in Phase 1b dose
expansion Cohort A with median duration of response not reached at
a median follow-up time of 8.5 months at data cut-off; next update
in 4Q 2023
- Bristol Myers Squibb exercised
first opt-in into 2019 cell therapy collaboration ($15 million
option fee received) and made a $35 million equity investment
- Cash and cash equivalents as well
as other financial assets not including the recent equity
investment by Bristol Myers Squibb amount to $377.7 million1
(€347.6) as of June 30, 2023; updated projected cash runway is late
2025
Tuebingen, Germany and
Houston, TX,
August 17, 2023 – 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 ended June
30, 2023.
“The interim clinical data update for IMA203
monotherapy demonstrated an encouraging initial objective response
rate in a range of solid cancer indications including durable
responses supporting fast-tracking IMA203 to patients, starting
with high-need solid cancers such as checkpoint-refractory melanoma
and uveal melanoma,” said Harpreet Singh, Ph.D., CEO and Co-Founder
of Immatics. “Beyond our recent IMA203 updates, we are pleased to
report that we closed the second quarter with a cash position
funding operations into late 2025. With this revised runway, we
anticipate reaching our most critical milestones including the
initiation of registration-directed trials for IMA203, as well as
delivering meaningful data to assess clinical proof of concept for
both TCER® programs IMA401 and IMA402.”
Second Quarter
2023 and Subsequent
Company Progress
Adoptive Cell Therapy
Programs
ACTengine®
IMA203: ACTengine® IMA203 TCR-T against PRAME is
currently being evaluated in an ongoing Phase 1b dose expansion
trial.
- As per the
latest data cut-off of April 4, 2023, ACTengine® IMA203 TCR-T
monotherapy Cohort A showed a 67% confirmed objective response rate
(cORR) in an interim clinical update announced on May 2, 2023. The
data covered 11 heavily pre-treated patients; the median duration
of response was not reached at a median follow-up time of 8.5
months. Patients were infused with IMA203 TCR-T cells at dose level
(DL) 4 or DL5 with a mean total infused dose of 3.67x109 TCR-T
cells (range 1.30-8.84x109 TCR-T cells).
- Cohort A IMA203 monotherapy TCR-T
treatment continues to show manageable tolerability with no
high-grade CRS and no ICANS; all 11 patients experienced expected
cytopenia (Grade 1-4) associated with lymphodepletion. 10 patients
(91%) had a low to moderate (Grade 1-2) cytokine release syndrome
(CRS), of which 5 patients (45%) had Grade 1, and 5 patients (45%)
had Grade 2 CRS.
- Objective responses were observed
independent of tumor type including checkpoint-refractory and BRAF
inhibitor-refractory cutaneous melanoma, platinum-resistant ovarian
cancer, uveal melanoma, head and neck cancer and synovial sarcoma.
Longest duration of responses were observed in cutaneous and uveal
melanoma with ongoing responses at 6, 9 and 10 months post infusion
at data cut-off.
- IMA203 in combination with
nivolumab (Cohort B) has been de-prioritized in the last-line
setting. Such a combination is being considered for the front-line
setting.
- IMA203CD8 (Cohort C) is a
next-generation monotherapy where IMA203 engineered T cells are
co-transduced with a CD8αβ co-receptor. IMA203CD8 is currently
being explored in DL4a (up to 0.8x109 TCR-T cells/m2
BSA).
- Next update on Immatics’ IMA203
Phase 1b cohorts, including the projected clinical development path
for PRAME-targeted TCR-T monotherapy towards registration-directed
trials is planned for 4Q 2023. Immatics’ IMA203 development
strategy to realize the multi-cancer opportunity of targeting PRAME
is based on two pillars aimed at:
- maximizing speed to market in one
to two last-line solid cancer types focusing on cutaneous melanoma,
uveal melanoma and potentially other tumor types with high PRAME
prevalence where clinical proof-of-concept has been demonstrated,
and
- broad development with expansion to
other cancer types, such as ovarian cancer, uterine cancer, lung
cancer, breast cancer, head and neck cancer and other tumor types
having a broad patient reach.
TCR-T pipeline
- Earlier this year, Bristol Myers
Squibb exercised its first option and entered into a global license
agreement with Immatics for the most advanced TCR-T product
candidate. As part of the agreement, Immatics received an option
payment of $15 million and is eligible for up to $490 million in
milestone payments in addition to tiered royalties on net sales of
the product.
TCR Bispecifics Programs
Immatics’ T cell engaging receptor (TCER®)
candidates are next-generation, half-life extended TCR Bispecific
molecules designed to maximize efficacy while minimizing toxicities
in patients through Immatics’ proprietary format using a
low-affinity T cell recruiter and a high-affinity TCR domain.
- TCER® IMA401
(MAGEA4/8) – Phase 1 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®). MAGEA4 and
MAGEA8 are expressed in multiple solid cancers including lung
cancer, head and neck cancer, melanoma, ovarian cancer, sarcoma and
others. IMA401 is being developed in collaboration with Bristol
Myers Squibb.
- TCER® IMA402
(PRAME) – Immatics submitted a clinical trial application
(CTA2) to the Paul-Ehrlich-Institute (PEI) in April 2023. Following
CTA acceptance, Immatics initiated the Phase 1/2 trial
investigating the company’s fully owned TCER® candidate IMA402 in
patients with recurrent and/or refractory solid tumors in August.
Initial focus indications are cutaneous and uveal melanoma, ovarian
cancer, lung cancer, uterine cancer and synovial sarcoma, among
others. A first clinical data update is planned for 2024. 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®).
Corporate
Updates
- On July 24, 2023, Bristol Myers
Squibb purchased 2,419,818 ordinary shares in a private placement
transaction at a subscription price per share of $14.463.
Additionally, Bristol Myers Squibb will appoint a member to the
Immatics Scientific Advisory Board.
Second Quarter 2023
Financial Results
Equity: The Company raised a total of $64
million in June through August through its ATM facility.
Cash Position: Cash and cash equivalents as well
as other financial assets total €347.6 million ($377.7 million1) as
of June 30, 2023, compared to €362.2 million ($393.6 million1) as
of December 31, 2022. The decrease is mainly due to our ongoing
research and development activities, partially offset by the option
fee received by Bristol Myers Squibb and funds raised in the
period. The Company projects an updated cash runway into late
2025.
Revenue: Total revenue, consisting of revenue
from collaboration agreements, was €22.4 million ($24.3 million1)
for the three months ended June 30, 2023, compared to €17.2 million
($18.7 million1) for the three months ended June 30, 2022. The
increase is mainly related to the recognition of revenue for the
opt-in agreement with Bristol Myers Squibb signed during the three
months ended June 30, 2023.
Research and Development Expenses: R&D
expenses were €27.3 million ($29.7 million1) for the three months
ended June 30, 2023, compared to €25.2 million ($27.4 million1) for
the three months ended June 30, 2022. The increase mainly resulted
from higher costs associated with the advancement of the clinical
and pre-IND pipeline of ACTengine® and TCER® candidates.
General and Administrative Expenses: G&A
expenses were €9.4 million ($10.2 million1) for the three months
ended June 30, 2023, compared to €8.7 million ($9.5 million1) for
the three months ended June 30, 2022.
Net Profit and Loss: Net loss was €24.6 million
($26.7 million1) for the three months ended June 30, 2023, compared
to a net loss of €14.0 million ($15.2 million1) for the three
months ended June 30, 2022. The increased net loss mainly resulted
from non-cash fair value adjustments of outstanding warrants.
Upcoming Investor Conferences
- Jefferies Cell & Genetic
Medicine Summit, New York, NY – September 26-27, 2023
- Jefferies London Healthcare
Conference, London, U.K. – November 14-16, 2023
To see the full list of events and
presentations, visit
https://investors.immatics.com/events-presentations.
About ImmaticsImmatics 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 as a means of disclosing material non-public
information. For regular updates you can also follow us on Twitter,
Instagram and LinkedIn.
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 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 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. Immatics undertakes no duty to update these
forward-looking statements.
For more information, please contact:
Media and Investor Relations Contact |
Eva Mulder or Charlotte Spitz |
|
Trophic Communications |
|
Phone: +31 6 52 33 15 79 |
|
immatics@trophic.eu |
|
Immatics N.V. |
|
Anja Heuer |
Sabrina Schecher, Ph.D. |
Senior Director, Corporate Communications |
Senior Director, Investor Relations |
Phone: +49 89 540415-606 |
Phone: +49 89 262002433 |
media@immatics.com |
InvestorRelations@immatics.com |
|
|
Unaudited Condensed Consolidated
Statement of Profit/(Loss) of Immatics N.V.
|
Three months ended June 30,
|
Six months ended June 30, |
|
2023 |
2022 |
2023 |
2022 |
|
(Euros in thousands, exceptper share
data) |
(Euros in thousands, exceptper
share data) |
Revenue from collaboration
agreements |
22,354 |
17,215 |
32,150 |
120,123 |
Research and development
expenses |
(27,317) |
(25,216) |
(54,898) |
(50,360) |
General and administrative
expenses |
(9,358) |
(8,683) |
(18,944) |
(17,961) |
Other income |
6 |
27 |
948 |
32 |
|
|
|
|
|
Operating
result |
(14,315) |
(16,657) |
(40,744) |
51,834 |
Change in fair value of liabilities for
warrants |
(13,105) |
(2,786) |
(5,708) |
13,743 |
Other financial
income |
3,954 |
7,015 |
6,748 |
8,774 |
Other financial
expenses |
(1,144) |
(407) |
(4,653) |
(1,524) |
|
|
|
|
|
Financial
result |
(10,295) |
3,822 |
(3,613) |
20,993 |
|
|
|
|
|
Profit/(loss) before
taxes |
(24,610) |
(12,835) |
(44,357) |
72,827 |
Taxes on
income |
— |
(1,145) |
— |
(1,145) |
Net
profit/(loss) |
(24,610) |
(13,980) |
(44,357) |
71,682 |
|
|
|
|
|
Net profit/(loss) per
share: |
|
|
|
|
Basic |
(0.32) |
(0.22) |
(0.58) |
1.12 |
Diluted |
(0.32) |
(0.22) |
(0.58) |
1.11 |
Unaudited Condensed Consolidated
Statement of Comprehensive Income/(Loss) of Immatics
N.V.
|
Three months ended June 30,
|
Six months ended June 30,
|
|
2023 |
2022 |
2023 |
2022 |
|
(Euros in thousands) |
(Euros in thousands) |
Net
profit/(loss) |
(24,610) |
(13,980) |
(44,357) |
71,682 |
Other comprehensive income/(loss) |
|
|
|
|
Items that may be reclassified subsequently to profit or
loss |
|
|
|
|
Currency translation differences from foreign
operations |
(224) |
778 |
340 |
1,338 |
|
|
|
|
|
Total comprehensive income/(loss) for the
year |
(24,834) |
(13,202) |
(44,017) |
73,020 |
|
|
|
|
|
Unaudited Condensed Consolidated
Statement of Financial Position of Immatics N.V.
|
|
|
|
As of |
|
June 30,2023 |
December 31,2022 |
|
|
|
|
(Euros in thousands) |
Assets |
|
|
Current assets |
|
|
Cash and cash equivalents |
130,405 |
148,519 |
Other financial assets |
217,222 |
213,686 |
Accounts
receivables |
330 |
1,111 |
Other current assets |
16,668 |
13,838 |
|
|
|
Total current assets |
364,625 |
377,154 |
Non-current assets |
|
|
Property, plant and
equipment |
27,188 |
13,456 |
Intangible
assets |
1,655 |
1,632 |
Right-of-use assets
|
14,749 |
13,033 |
Other non-current
assets |
1,972 |
2,545 |
|
|
|
Total non-current
assets |
45,564 |
30,666 |
|
|
|
Total assets |
410,189 |
407,820 |
|
|
|
Liabilities and shareholders’ equity |
|
|
Current liabilities |
|
|
Provisions |
3,117 |
- |
Accounts
payables |
19,904 |
13,056 |
Deferred
revenue |
67,997 |
64,957 |
Liabilities for
warrants |
22,622 |
16,914 |
Lease
liabilities |
2,737 |
2,159 |
Other current
liabilities |
7,929 |
9,366 |
|
|
|
Total current liabilities |
124,306 |
106,452 |
Non-current liabilities |
|
|
Deferred
revenue |
53,559 |
75,759 |
Lease
liabilities |
14,085 |
12,403 |
Other non-current
liabilities |
26 |
42 |
|
|
|
Total non-current liabilities |
67,670 |
88,204 |
Shareholders’ equity |
|
|
Share capital |
804 |
767 |
Share premium |
763,206 |
714,177 |
Accumulated
deficit |
(544,656) |
(500,299) |
Other reserves |
(1,141) |
(1,481) |
|
|
|
Total shareholders’ equity |
218,213 |
213,164 |
|
|
|
Total liabilities and shareholders’ equity |
410,189 |
407,820 |
|
|
|
Unaudited Condensed Consolidated
Statement of Cash Flows of Immatics N.V.
|
|
|
|
Six months ended June 30,
|
|
2023 |
2022 |
|
|
|
|
(Euros in thousands) |
Cash flows from operating activities |
|
|
Net
profit/(loss) |
(44,357) |
71,682 |
Taxes on
income |
— |
1,145 |
Profit/(loss) before
tax |
(44,357) |
72,827 |
Adjustments for: |
|
|
Interest
income |
(4,999) |
(23) |
Depreciation and
amortization |
3,666 |
3,407 |
Interest
expenses |
401 |
538 |
Equity settled share-based
payment |
11,615 |
11,262 |
Net foreign exchange differences and expected credit
losses |
4,081 |
(7,834) |
Change in fair value of liabilities for
warrants |
5,708 |
(13,743) |
Changes in: |
|
|
Decrease/(increase) in accounts
receivables |
781 |
(280) |
Decrease/(increase) in other
assets |
765 |
(6,903) |
(Decrease)/increase in deferred revenue, accounts payables and
other
liabilities |
(9,889) |
96,933 |
Interest
received |
2,051 |
23 |
Interest paid |
(146) |
(434) |
Income tax
paid |
— |
— |
|
|
|
Net cash (used in)/provided by operating
activities |
(30,323) |
155,773 |
|
|
|
Cash flows from investing activities |
|
|
Payments for property, plant and
equipment |
(15,004) |
(1,965) |
Payments for intangible
assets |
(154) |
(6) |
Proceeds from disposal of property, plant and
equipment |
— |
1 |
Payments for investments classified in Other financial
assets |
(170,326) |
(59,253) |
Proceeds from maturity of investments classified in Other financial
assets |
164,929 |
12,695 |
|
— |
|
Net cash (used in)/provided by investing
activities |
(20,555) |
(48,528) |
|
|
|
Cash flows from financing activities |
|
|
Proceeds from issuance of shares to equity
holders |
38,608 |
17,112 |
Transaction costs deducted from
equity |
(1,157) |
(515) |
Repayment of lease
liabilities |
(1,866) |
(1,394) |
|
|
|
Net cash provided
by/(used in)
financing
activities |
35,585 |
15,203 |
|
|
|
Net (decrease)/increase in cash
and cash
equivalents |
(15,293) |
122,448 |
|
|
|
Cash and cash equivalents at beginning of the
year |
148,519 |
132,994 |
|
|
|
Effects of exchange rate changes and expected credit losses on cash
and cash
equivalents |
(2,821) |
9,683 |
|
|
|
Cash and cash equivalents at end of the
year |
130,405 |
265,125 |
|
|
|
Unaudited Condensed Consolidated
Statement of Changes in Shareholders’ equity of Immatics
N.V.
|
|
|
|
|
|
(Euros in thousands) |
Sharecapital |
Sharepremium |
Accumulateddeficit |
Otherreserves |
Totalshare-holders’equity
|
Balance as of January 1,
2022 |
629 |
565,192 |
(537,813) |
(3,945) |
24,063 |
Other comprehensive
income |
— |
— |
— |
1,338 |
1,338 |
Net profit |
— |
— |
71,682 |
— |
71,682 |
Comprehensive income for the
year |
— |
— |
71,682 |
1,338 |
73,020 |
Equity-settled share-based
compensation |
— |
11,262 |
— |
— |
11,262 |
Share options
exercised |
— |
1 |
— |
— |
1 |
Issue of share capital – net of transaction
costs |
24 |
16,571 |
— |
— |
16,595 |
|
|
|
|
|
|
Balance as of June 30, 2022 |
653 |
593,026 |
(466,131) |
(2,607) |
124,941 |
|
|
|
|
|
|
Balance as of January 1,
2023 |
767 |
714,177 |
(500,299) |
(1,481) |
213,164 |
Other comprehensive
income |
— |
— |
— |
340 |
340 |
Net loss |
— |
— |
(44,357) |
— |
(44,357) |
Comprehensive loss for the
year |
— |
— |
(44,357) |
340 |
(44,017) |
Equity-settled share-based
compensation |
— |
11,615 |
— |
— |
11,615 |
Share options
exercised |
— |
40 |
— |
— |
40 |
Issue of share capital – net of transaction
costs |
37 |
37,374 |
— |
— |
37,411 |
|
|
|
|
|
|
Balance as of June 30, 2023 |
804 |
763,206 |
(544,656) |
(1,141) |
218,213 |
|
|
|
|
|
|
1 All amounts translated using the exchange rate
published by the European Central Bank in effect as of June 30,
2023 (1 EUR = 1.0866 USD).
2 Clinical Trial Application (CTA) is the
European equivalent of an Investigational New Drug (IND)
application.3 Exact price per share $14.4639.
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