14.05.2024 13:00:04 - dpa-AFX: GNW-Adhoc: Immatics Announces First Quarter 2024 Financial Results and Business Update

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)
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Name WKN Börse Kurs Datum/Zeit Diff. Diff. % Geld Brief Erster Schluss
IMMATICS N.V. A2P72S Frankfurt 10,440 28.05.24 16:57:47 -0,460 -4,22% 0,000 0,000 10,510 10,900

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