- Interim clinical update on ACTengine®
IMA203 TCR-T monotherapy targeting PRAME demonstrated high
confirmed objective response rate (cORR) of 50% (6/12) at or above
target dose across Phase 1a and Phase 1b; confirmed responses seen
across different solid tumor types: cutaneous melanoma, ovarian
cancer, head and neck cancer, uveal melanoma, and synovial
sarcoma
- First patient
treated with IMA203CD8, a 2nd generation ACTengine® TCR-T
monotherapy product candidate targeting PRAME in Phase 1b expansion
cohort C; patient treatment ongoing in all three Phase 1b expansion
cohorts
- Next-generation
TCR Bispecific, TCER® IMA402 targeting PRAME showed high anti-tumor
activity in vivo, low T cell engager-associated toxicities and
favorable pharmacodynamic characteristics in preclinical studies;
Phase 1/2 clinical trial on track to start in 2023
- Joint
publication with University of Pennsylvania in Science
Translational Medicine on Immatics’ novel proprietary target COL6A3
exon 6
- $110 million
underwritten offering of 10,905,000 ordinary shares successfully
completed on Oct 12, 2022
- Cash and cash
equivalents as well as other financial assets of $301.5 million1
(€309.3 million) as of September 30, 2022. Additional cash from the
recent public offering in October 2022 funds company operations
into 2025
Tuebingen,
Germany and Houston,
Texas, November
17,
2022 – 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 September 30, 2022.
“The initial results from our Phase 1a and Phase
1b cohort A showed a highly encouraging confirmed objective
response rate of 50% for patients treated at or above target dose.
Early data from cohort A alone have shown a confirmed objective
response rate of 80%. With these encouraging results, we have built
momentum for our multi-cohort strategy designed to leverage the
full clinical potential of targeting PRAME,” commented Harpreet
Singh, Ph.D., CEO and Co-Founder of Immatics. “We look forward to
sharing the next data readouts from all three Phase 1b expansion
cohorts in 2023, as well as initiating the Phase 1/2 clinical trial
of our TCR Bispecific candidate, TCER® IMA402, targeting PRAME.
With the recent addition of new capital, we have the resources to
deliver on our corporate objectives for 2023 and to fund operations
into 2025.”
Third Quarter 2022 and
Subsequent Company Progress
Adoptive Cell Therapy
Programs
-
ACTengine® IMA203 (PRAME) – In October, Immatics
provided an interim update from the ongoing IMA203 TCR-T
monotherapy. The update covered data from 27 patients in the
completed Phase 1a dose escalation and first 5 patients in the
Phase 1b dose expansion (cohort A) treated with IMA203 monotherapy.
- Treatment with
IMA203 continues to show manageable tolerability.
- Confirmed objective response rate
(cORR): 50% (6/12) at target dose or above with at least 1 billion
infused TCR-T cells across Phase 1a and 1b; thereof 80% cORR (4/5)
in Phase 1b patients alone with all responses ongoing at data
cut-off.
- Confirmed responses observed across
different solid tumor types: cutaneous melanoma, ovarian cancer,
head and neck cancer, uveal melanoma, and synovial sarcoma.
- Immatics has
introduced improvements that may influence clinical outcomes,
including higher cell doses, optimizing the cell product through
manufacturing enhancements and working with disease area experts to
gradually reduce the patient fraction that are very heavily
pre-treated with extreme tumor burden. Immatics continues to
implement such improvements to the IMA203 trial.
- ACTengine®
IMA203 is currently being evaluated in three ongoing Phase 1b dose
expansion cohorts:
- Cohort A -
IMA203 monotherapy interim analysis demonstrated cORR in 4 of 5
patients (80%) with early signs of prolonged durability at 12 weeks
of follow-up. All responses were ongoing at data cut-off. Patients
are treated at provisional recommended phase 2 dose (RP2D) and dose
level (DL) 5.
- Cohort B – The
first patient in the Phase 1b expansion cohort B was treated with
IMA203 in combination with the PD-1 immune checkpoint inhibitor
nivolumab in May 2022. Patients will be treated at RP2D.
- Cohort C – The
first patient was treated in August 2022 with IMA203CD8, Immatics’
2nd -generation monotherapy product candidate in which IMA203
engineered T cells are co-transduced with a CD8αβ co-receptor that
engages functional CD4 and CD8 T cells directed against PRAME. As
IMA203CD8 is a novel product candidate under a new IND2 amendment,
a staggered enrollment is being implemented with the first three
patients being treated at DL3. Following the initial DL3, patients
will be treated at DL4 and DL5.
- Further data
read-outs on all three individual cohorts are planned throughout
2023.
2) IND = Investigational New Drug
- ACTengine®
IMA204 (COL6A3 exon 6) – Immatics and the University of
Pennsylvania co-authored a research paper published in the
peer-reviewed journal, Science Translational Medicine, that
highlighted Immatics’ differentiated approach to develop TCR-based
therapies through its proprietary discovery platforms, XPRESIDENT®
and XCEPTOR®. With this approach, Immatics identified a novel
proprietary HLA-A*02:01-presented target generated by a
tumor-specific alternative splicing event in the abundantly
expressed protein collagen type VI alpha-3 (COL6A3). This target is
expressed at high target density across multiple solid cancer
indications and specific to the tumor stroma. Targeting tumor
stroma provides an innovative therapeutic opportunity to disrupt
the tumor microenvironment. Immatics has engineered
target-specific, affinity-enhanced proprietary TCRs, one of them
being CD8-independent and thus facilitating targeting of COL6A3
exon 6 positive cells by both CD4 and CD8 T cells. The TCR-T
candidate, IMA204 was able to eliminate tumor cells at
physiological target levels in in vitro studies and in vivo mouse
models. Due to Immatics focusing its clinical resources on the
three IMA203 Phase 1b cohorts as well as accelerating the clinical
development for the PRAME TCER® IMA402, the company has delayed the
IND submission for an ACTengine® candidate directed against COL6A3
exon 6.
TCR Bispecifics Programs
- TCER®
IMA401 (MAGEA4/8) – IMA401 is being developed in
collaboration with Bristol Myers Squibb; 9 centers in Germany have
been activated and are enrolling patients.
- TCER® IMA402
(PRAME) – In preclinical data presented at the European
Society for Medical Oncology (ESMO) Congress in September 2022,
TCER® IMA402 showed potent and selective activity against
PRAME-positive tumor cell lines in vitro. In vivo studies in mice
demonstrated dose-dependent anti-tumor activity confirming that
sufficiently high drug doses are key to achieving the desired
anti-tumor effects over a prolonged time period. Pharmacokinetic
characteristics of the half-life extended IMA402 suggest the
potential for a favorable dosing regimen in patients with prolonged
drug exposure at therapeutic levels. Immatics has completed the
manufacturing process development for IMA402, and manufacturing of
the clinical batch is on track for 2H 2022 with a planned start of
the Phase 1/2 trial in 2023. The submission of the CTA/IND3
application is planned for 2Q 2023.
3) Clinical Trial Application (CTA) is the equivalent of an
Investigational New Drug (IND) application in Europe
-
TCER® Platform – In November,
Immatics presented preclinical data of its next-generation,
half-life extended TCR Bispecific format which showed higher
potency in vitro than multiple other established formats, at the
37th Annual Meeting of the Society for Immunotherapy of Cancer
(SITC). The proprietary TCER® format consists of three distinct
elements designed for optimal efficacy and minimal toxicity risk in
patients: 1) high affinity TCR domains targeting tumor-specific
peptide HLA molecules 2) low affinity T cell recruiter against
CD3/TCR, and 3) a human IgG Fc region (silenced) for half-life
extension, favorable stability and manufacturability. The poster
can be accessed on Immatics’ website here.
- PRAME
Target (IMA203, IMA402) – In November,
Immatics presented comprehensive target characterization and
validation data at the SITC Annual Meeting. The data support PRAME
as a highly relevant target for Immatics’ TCR-based therapies,
ACTengine® IMA203 and TCER® IMA402. These therapies have the
potential to address a wide variety of cancer indications such as
cutaneous melanoma, ovarian cancer, uterine cancer, non-small cell
lung cancer, triple-negative breast cancer, head and neck cancer
and uveal melanoma, among others. The poster can be accessed on
Immatics’ website here.
Corporate
Developments
In October 2022, Immatics successfully completed
the underwritten public offering of 10,905,000 ordinary shares at a
price of $10.09 per ordinary share, raising approximately $110
million before deducting underwriting discount and offering
expenses. The offering included participation from investors
including Armistice Capital Master Fund Ltd., Dellora Investments,
EcoR1 Capital, Nantahala Capital, Perceptive Advisors, Rock Springs
Capital, RTW Investments, LP, Samsara BioCapital, SilverArc
Capital, Sofinnova Investments, Wellington Management, 683 Capital
and other specialist biotech investors.
On October 24, 2022, GSK provided Immatics with
notice of its decision to terminate their collaboration. Initially
announced on February 20, 2020, the terms of the agreement included
a €45 Million (~$50 Million) upfront payment to Immatics and the
potential for additional milestone and royalty payments in return
for access to two of Immatics’ TCR-T programs. As communicated to
Immatics, GSK’s decision was made unrelated to the programs and the
progress achieved in the collaboration to date. The
termination will be effective on December 26, 2022.
Third Quarter 2022
Financial Results
Cash Position: Cash and cash equivalents as well
as other financial assets total €309.3 million ($301.5 million1) as
of September 30, 2022 compared to €324.4 million ($316.2 million1)
as of June 30, 2022. The decrease is mainly due to our ongoing
research and development activities. This does not include $110
million gross proceeds from our public offering in October 2022.
Adding those proceeds, the Company projects a cash runway into
2025.Revenue: Total revenue, consisting of revenue from
collaboration agreements, was €15.1 million ($14.7 million1) for
the three months ended September 30, 2022, compared to €6.4 million
($6.2 million1) for the three months ended September 30, 2021. The
increase is mainly related to the increased recognition of revenue
for the multiple ongoing collaboration agreements.Research and
Development Expenses: R&D expenses were €28.6 million ($27.9
million1) for the three months ended September 30, 2022, compared
to €21.2 million ($20.7 million1) for the three months ended
September 30, 2021. The increase is mainly related to increased
expenses for clinical trials.General and Administrative Expenses:
G&A expenses were €8.4 million ($8.2 million1) for the three
months ended September 30, 2022, compared to €8.3 million ($8.1
million1) for the three months ended September 30, 2021.
Net Income/Loss: Net loss was €20.9 million
($20.4 million1) for the three months ended September 30, 2022,
compared to a net loss of €27.2 million ($26.5 million1) for the
three months ended September 30, 2021. The decrease was primarily
the result of the increased revenue from multiple collaboration
agreements.
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 September
30, 2022 (1 EUR = 0.9748 USD).
To see the full list of events and
presentations, visit
https://investors.immatics.com/events-presentations
– END –
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.
For regular updates about Immatics, visit www.immatics.com. You
can also follow us on Instagram, Twitter 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 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. 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 and Investor Relations Contact |
Jacob Verghese or Eva Mulder |
Trophic Communications |
Phone: +49 89 2070 89831 or +31 6 52 33 1579 |
immatics@trophic.eu |
Immatics N.V. |
|
Anja Heuer |
Jordan Silverstein |
Director, Corporate Communications |
Head of Strategy |
Phone: +49 89 540415-606 |
Phone: +1 281 810 7545 |
media@immatics.com |
InvestorRelations@immatics.com |
Unaudited Condensed Consolidated Statement of Financial
Position of Immatics N.V.
|
|
|
|
|
As of |
|
|
September 30, 2022 |
December 31, 2021
|
|
|
|
|
|
|
(Euros in thousands) |
|
Assets |
|
|
|
Current assets |
|
|
|
Cash and cash
equivalents |
178,047 |
132,994 |
|
Other financial
assets |
131,287 |
12,123 |
|
Accounts
receivable |
1,139 |
682 |
|
Other current
assets |
11,838 |
6,408 |
|
|
|
|
|
Total current
assets |
322,311 |
152,207 |
|
Non-current assets |
|
|
|
Property, plant and
equipment |
11,737 |
10,506 |
|
Intangible
assets |
1,542 |
1,315 |
|
Right-of-use assets
|
14,688 |
9,982 |
|
Other non-current
assets |
4,015 |
636 |
|
|
|
|
|
Total non-current
assets |
31,982 |
22,439 |
|
|
|
|
|
Total
assets |
354,293 |
174,646 |
|
|
|
|
|
Liabilities and shareholders’ equity |
|
|
|
Current liabilities |
|
|
|
Provisions |
4,372 |
51 |
|
Accounts
payable |
12,828 |
11,624 |
|
Deferred
revenue |
80,150 |
50,402 |
|
Other financial
liabilities |
19,982 |
27,859 |
|
Lease
liabilities |
2,424 |
2,711 |
|
Other current
liabilities |
4,366 |
2,501 |
|
|
|
|
|
Total current
liabilities |
124,122 |
95,148 |
|
Non-current liabilities |
|
|
|
Deferred
revenue |
103,215 |
48,225 |
|
Lease
liabilities |
13,857 |
7,142 |
|
Other non-current
liabilities |
55 |
68 |
|
|
|
|
|
Total non-current
liabilities |
117,127 |
55,435 |
|
Shareholders’ equity |
|
|
|
Share capital |
657 |
629 |
|
Share premium |
602,272 |
565,192 |
|
Accumulated
deficit |
(487,067) |
(537,813) |
|
Other reserves |
(2,818) |
(3,945) |
|
|
|
|
|
Total shareholders’
equity |
113,044 |
24,063 |
|
|
|
|
|
Total liabilities and shareholders’
equity |
354,293 |
174,646 |
|
|
|
|
|
Unaudited Condensed Consolidated Statement of
Profit/(Loss) of Immatics N.V.
|
|
|
|
|
|
|
Three months ended September 30,
|
Nine months ended September 30, |
|
|
2022 |
2021 |
2022 |
2021 |
|
|
(Euros in thousands, exceptshare and per
share data) |
(Euros in thousands, exceptshare
and per share data) |
|
Revenue from collaboration
agreements |
15,060 |
6,443 |
135,183 |
19,036 |
|
Research and development
expenses |
(28,572) |
(21,225) |
(78,933) |
(64,613) |
|
General and administrative
expenses |
(8,422) |
(8,266) |
(26,383) |
(24,968) |
|
Other income |
9 |
47 |
42 |
311 |
|
|
|
|
|
|
|
Operating
result |
(21,925) |
(23,001) |
29,909 |
(70,234) |
|
Financial
income |
7,839 |
1,421 |
16,613 |
4,474 |
|
Financial
expenses |
(426) |
(171) |
(1,950) |
(1,400) |
|
Change in fair value of warrant
liabilities |
(5,865) |
(5,452) |
7,877 |
(9,388) |
|
|
|
|
|
|
|
Financial
result |
1,548 |
(4,202) |
22,540 |
(6,314) |
|
|
|
|
|
|
|
Profit/(loss) before
taxes |
(20,377) |
(27,203) |
52,449 |
(76,548)
|
|
Taxes on
income |
(558) |
— |
(1,703) |
— |
|
Net
profit/(loss) |
(20,935) |
(27,203) |
50,746 |
(76,548)
|
|
|
|
|
|
|
|
Net profit/(loss) per
share: |
|
|
|
|
|
Basic |
(0.32) |
(0.43) |
0.79 |
(1.22) |
|
Diluted |
(0.32) |
(0.43) |
0.78 |
(1.22) |
|
Weighted average shares
outstanding: |
|
|
|
|
|
Basic |
65,634,347 |
62,911,465 |
64,508,091 |
62,909,797 |
|
Diluted |
65,634,347 |
62,911,465 |
65,239,279 |
62,909,797 |
|
Unaudited Condensed Consolidated Statement of
Comprehensive Income/(Loss) of Immatics N.V.
|
Three months ended
September 30, |
Nine months ended September 30,
|
|
2022 |
2021 |
2022 |
2021 |
|
(Euros in thousands) |
(Euros in thousands) |
Net
profit/(loss) |
(20,935) |
(27,203) |
50,746 |
(76,548) |
Other comprehensive income/(loss) |
|
|
|
|
Items that may be reclassified subsequently to profit or loss, net
of tax |
|
|
|
|
Currency translation differences from foreign
operations |
(211) |
1,252 |
1,127 |
2,576 |
|
|
|
|
|
Total comprehensive income/(loss) for the
period |
(21,146) |
(25,951) |
51,873 |
(73,972) |
|
|
|
|
|
Unaudited Condensed Consolidated Statement of Cash
Flows of Immatics N.V.
|
|
|
|
Nine months ended September 30,
|
|
2022 |
2021 |
|
|
|
|
(Euros in thousands) |
Cash flows from operating activities |
|
|
Net
profit/(loss) |
50,746 |
(76,548) |
Adjustments for: |
|
|
Interest
income |
(606) |
(102) |
Depreciation and
amortization |
5,218 |
3,967 |
Interest
expense |
748 |
213 |
Equity settled share-based
payment |
16,725 |
21,671 |
Net foreign exchange
differences* |
(11,974) |
(3,905) |
Change in fair value of warrant
liabilities |
(7,877) |
9,388 |
Changes in: |
|
|
(Increase)/decrease in accounts
receivable |
(457) |
525 |
(Increase) in other
assets |
(6,523) |
(390) |
Increase/(decrease) in accounts payable and other
liabilities |
85,888 |
(14,233) |
Interest
received |
213 |
144 |
Interest paid |
(521) |
(213) |
|
|
|
Net cash provided
by/(used in) operating
activities* |
131,580 |
(59,483) |
|
|
|
Cash flows from investing activities |
|
|
Payments for property, plant and
equipment |
(3,390) |
(3,277) |
Cash paid for investments classified in Other financial
assets |
(128,726) |
(11,362) |
Cash received from maturity of investments classified in Other
financial
assets |
12,695 |
24,447 |
Payments for intangible
assets |
(220) |
(487) |
Proceeds from disposal of property, plant and
equipment |
52 |
— |
|
|
|
Net cash (used in)/provided
by investing
activities |
(119,588) |
9,321 |
|
|
|
Cash flows from financing activities |
|
|
Proceeds from issuance of shares to equity
holders |
21,009 |
75 |
Transaction costs deducted from
equity |
(626) |
— |
Payments for
leases |
(2,162) |
(2,102) |
|
|
|
Net cash provided
by/(used in) financing
activities |
18,221 |
(2,027) |
|
|
|
Net increase/(decrease) in cash and cash
equivalents* |
30,213 |
(52,189) |
|
|
|
Cash and cash equivalents at beginning of
period |
132,994 |
207,530 |
|
|
|
Effects of exchange rate changes on cash and cash
equivalents* |
14,840 |
5,953 |
|
|
|
Cash and cash equivalents at end of
period |
178,047 |
161,294 |
|
|
|
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,
2021 |
629 |
538,695 |
(444,478) |
(7,459) |
87,387 |
|
Other comprehensive
income |
— |
— |
— |
2,576 |
2,576 |
|
Net loss |
— |
— |
(76,548) |
— |
(76,548) |
|
Comprehensive income/(loss) for the
year |
— |
— |
(76,548) |
2,576 |
(73,972) |
|
Equity-settled share-based
compensation |
— |
21,671 |
— |
— |
21,671 |
|
Share options
exercised |
— |
75 |
— |
— |
75 |
|
|
|
|
|
|
|
|
Balance as of September 30,
2021 |
629 |
560,441 |
(521,026) |
(4,883) |
35,161 |
|
|
|
|
|
|
|
|
Balance as of January 1,
2022 |
629 |
565,192 |
(537,813) |
(3,945) |
24,063 |
|
Other comprehensive
income |
— |
— |
— |
1,127 |
1,127 |
|
Net profit |
— |
— |
50,746 |
— |
50,746 |
|
Comprehensive income for the
year |
— |
— |
50,746 |
1,127 |
51,873 |
|
Equity-settled share-based
compensation |
— |
16,725 |
— |
— |
16,725 |
|
Share options
exercised |
— |
202 |
— |
— |
202 |
|
Issue of share capital – net of transaction costs |
28 |
20,153 |
— |
— |
20,181 |
|
|
|
|
|
|
|
|
Balance as of September 30,
2022 |
657 |
602,272 |
(487,067) |
(2,818) |
113,044 |
|
|
|
|
|
|
|
|
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