Immatics Announces Third Quarter 2024 Financial Results, Business Update and First Clinical Data on TCER® IMA402 Targeting PRAME
IMTXW 11.18.2024
The Company will now target five major cancer types with its four clinically active compounds across both TCR-T cell therapies and TCR-based Bispecifics
- Today, Company discloses first clinical data from the TCR Bispecific molecule, TCER® IMA402 targeting PRAME, in the Phase 1 dose escalation trial, demonstrating a favorable tolerability profile and signs of dose-dependent and PRAME expression-dependent clinical activity, including first objective responses in melanoma patients; early pharmacokinetics data indicate a median half-life of 7 days, potentially enabling bi-weekly dosing; dose escalation is ongoing
- SUPRAME, the randomized-controlled Phase 3 trial to evaluate ACTengine® IMA203 in 2L+ metastatic melanoma patients, planned to commence in
December 2024 ; pre-specified interim data analysis planned for early 2026 - Recently, Company presented Phase 1b clinical data on ACTengine® IMA203 targeting PRAME that demonstrate deep and durable responses in heavily pretreated metastatic melanoma patients treated at RP2D; IMA203 continues to maintain a favorable tolerability profile in patients treated across all dose levels
- Next-generation ACTengine® IMA203CD8 Phase 1a dose escalation data demonstrate enhanced pharmacology and potency per cell; TCR-T candidate to be evaluated for future development in solid cancers with medium-level PRAME copy numbers, such as ovarian and endometrial cancer
- Clinical proof-of-concept data from the ongoing Phase 1 dose escalation trial with TCER® IMA401 targeting MAGEA4/8 demonstrate initial clinical anti-tumor activity in multiple tumor types and a manageable tolerability profile; dose escalation is ongoing
$150 million public offering completed onOctober 15, 2024 - As of
September 30, 2024 , cash and cash equivalents as well as other financial assets amount to$549.2 million 1(€490.5 million), not including the cash inflow from the public offering onOctober 15, 2024 ; updated cash reach guidance into 2H 2027
“This year,
Third Quarter 2024 and Subsequent Company Progress
TCER® IMA402 (PRAME)
Today,
Patient Population: As of the data cut-off on
Safety: IMA402 demonstrated a favorable tolerability profile in the 33 patients treated. The most common treatment-related adverse events (AEs) were mostly mild to moderate cytokine release syndrome (CRS) and transient lymphopenia. Step dosing has been implemented and dose escalation is ongoing. The maximum tolerated dose has not yet been determined.
Pharmacokinetics: Early pharmacokinetic data indicate a median half-life of approximately seven days, potentially enabling bi-weekly dosing.
Initial Anti-Tumor Activity: Initial signs of clinical activity have been observed and are associated with PRAME expression and IMA402 dose levels administered.
- In the PRAME-negative patient population across all doses and indications, only one patient out of seven (14%) showed tumor shrinkage of -2.9%.
- In comparison, in the PRAME-positive or non-tested patients across all indications treated with low dose levels (DLs 1-6), tumor shrinkage was observed in 25% (3/12) of patients, including one unconfirmed partial response in a cutaneous melanoma patient.
- Nine patients with tumors that tested PRAME-positive or were not tested for PRAME received a relevant dose (8 patients at DL7 and 1 patient at DL8). 78% (7/9) thereof experienced shrinkage of their target lesions, including several patients with significant ongoing tumor shrinkage:
- one cutaneous melanoma patient with an ongoing (at 3 months post first dose at data cut-off) confirmed partial response with -40.2% tumor shrinkage treated at DL7;
- two patients with ongoing (at 6+ weeks and 8+ months) stable diseases with significant tumor shrinkage (-27.5% in a patient with cutaneous melanoma at DL8 and at first scan; -25% in a patient with uveal melanoma deepening over time and treated at escalating doses starting at DL4 and currently at DL7);
- one ovarian cancer patient with ongoing (at 3 months) stable disease and tumor shrinkage of -13% started at DL6 and currently at DL7.
Early Signs of Clinical Activity Associated with PRAME Expression and IMA402 Dose
*Patients who received DL7 or higher, either from start or as part of intra-patient dose-escalation;#continuing treatment; PD: Progressive Disease; SD: Stable Disease; PR: Partial Response; cPR: confirmed Partial Response; BOR: Best Overall Response; BL: Baseline; NT: not tested or not evaluable for PRAME expression
More information and details on the IMA402 clinical data are available on the Events & Presentations page of the
Based on these initial signs of dose-dependent and PRAME target expression-dependent clinical activity observed during dose escalation, the Company will continue to evaluate IMA402 at higher dose levels to determine the optimal therapeutic dose. The next data update on IMA402 is planned for 2025.
TCER® IMA401 (MAGEA4/8)
On
As of data cut-off on
Proof-of-concept clinical data from the Phase 1a first-in-human dose escalation basket trial showed initial anti-tumor activity in multiple tumor types, durable objective responses, including confirmed responses ongoing at 13+ months, a manageable tolerability profile and a half-life of 14+ days.
Treatment with IMA401 monotherapy in patients with relevant IMA401 doses and MAGEA4/8highlevels (N=17) demonstrated:
- Objective response rate of 29% with confirmed responses observed in 25% of patients
- Disease control rate of 53% and tumor shrinkage of 53%
As the clinical trial progresses, the Company aims to further leverage the potential of IMA401 by focusing on the enrollment of indications with high MAGEA4/8 target expression, such as lung and head and neck cancer patients, seeking to optimize the treatment schedule and also exploring the incremental clinical benefit available to patients through combining IMA401 with a checkpoint inhibitor. The next data update on IMA401 is expected in 2025.
ACTengine® Cell Therapy Programs
ACTengine® IMA203
On
As of the data cut-off on
- Confirmed objective response rate of 54% and an objective response rate of 62%
- Disease control rate of 92% and tumor shrinkage in 88% of patients
- 12.1 months median duration of response, 6 months median progression-free survival and >1-year median progression-free survival in patients with deep responses
- Median overall survival has not yet been reached
IMA203 monotherapy has maintained a favorable tolerability profile with no treatment-related Grade 5 events in the entire safety population (N=70 Phase 1a and Phase 1b patients across all dose levels and all tumor types).
Based on the Phase 1b data and discussions with the
SUPRAME will evaluate IMA203 targeting PRAME in 360 HLA-A*02:01-positive patients with second-line or later (2L+) unresectable or metastatic melanoma who have received prior treatment with a checkpoint inhibitor. Patients will be randomized 1:1 for IMA203 or investigator’s choice of selected approved treatments in the 2L+ setting, including nivolumab/relatlimab, nivolumab, ipilimumab, pembrolizumab, lifileucel (
Patient enrollment for SUPRAME is forecast to be completed in 2026, and a pre-specified interim analysis is planned for early 2026.
ACTengine® IMA203CD8 (GEN2) monotherapy
On
As of the data cut-off on
- Confirmed objective responses observed in 41% of patients
- Median duration of response of 9.2 months at a median follow-up of 13.1 months
- Tumor shrinkage of 84% and disease control rate at week 6 of 85%
- 10 out of 17 responses were ongoing, of which three confirmed responses were ongoing at 14+, 15+ and 24+ months
- Deep responses with ≥50% tumor size reduction were observed in 11 out of 17 responders. This group included two patients with complete response of target lesions, of which one patient showed a complete metabolic response according to PET-CT scan
IMA203CD8 monotherapy has maintained a manageable tolerability profile in the 44 patients treated.
Based on the enhanced pharmacology of IMA203CD8 demonstrated in this trial, the evaluation of higher doses of IMA203CD8 in the ongoing dose escalation trial opens the possibility of addressing hard-to-treat solid tumor indications with a medium-level of PRAME copy numbers, such as ovarian cancer and endometrial cancer.
Corporate Development
In
Third Quarter 2024 Financial Results
Cash Position:Cash and cash equivalents as well as other financial assets total
Revenue:Total revenue, consisting of revenue from collaboration agreements, was
Research and Development Expenses:R&D expenses were
Net Profit and Loss:Net loss was
Full financial statements can be found in the 6-K filed with the
Upcoming Investor Conferences
To see the full list of events and presentations, visitwww.investors.immatics.com/events-presentations.
About IMA402TCER® IMA402 is a drug candidate owned by
- END -
About
Forward-Looking StatementsCertain 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
For more information, please contact:
| Media | |
| Phone: +49 171 3512733 | |
| immatics@trophic.eu |
| Head of Strategy | |
| Phone: +1 346 319-3325 | |
| InvestorRelations@immatics.com |
| Three months ended September 30, | Nine months ended | |||
| 2024 | 2023 | 2024 | 2023 | |
| (Euros in thousands, exceptper share data) | (Euros in thousands, exceptper share data) | |||
| Revenue from collaboration agreements | 50,559 | 5,926 | 99,583 | 38,076 |
| Research and development expenses | (38,906) | (30,498) | (106,230) | (85,396) |
| General and administrative expenses | (11,156) | (8,881) | (32,925) | (27,825) |
| Other income | 17 | 186 | 54 | 1,134 |
| Operating result | 514 | (33,267) | (39,518) | (74,011) |
| Change in fair value of liabilities for warrants | 3,833 | (1,395) | 4,228 | (7,103) |
| Other financial income | 5,889 | 9,748 | 18,707 | 14,414 |
| Other financial expenses | (12,589) | (1,575) | (5,342) | (4,146) |
| Financial result | (2,867) | 6,778 | 17,593 | 3,165 |
| Loss before taxes | (2,353) | (26,489) | (21,925) | (70,846) |
| Taxes on income | (6,217) | — | (7,720) | — |
| Net loss | (8,570) | (26,489) | (29,645) | (70,846) |
| Net loss per share: | ||||
| Basic | (0.08) | (0.32) | (0.29) | (0.90) |
| Diluted | (0.11) | (0.32) | (0.31) | (0.90) |
| Three months ended | Nine months ended | |||
| 2024 | 2023 | 2024 | 2023 | |
| (Euros in thousands) | (Euros in thousands) | |||
| Net loss | (8,570) | (26,489) | (29,645) | (70,846) |
| Other comprehensive income | ||||
| Items that may be reclassified subsequently to profit or loss | ||||
| Currency translation differences from foreign operations | (1,377) | 429 | (579) | 769 |
| Total comprehensive loss for the year | (9,947) | (26,060) | (30,224) | (70,077) |
| As of | ||
| (Euros in thousands) | ||
| Assets | ||
| Current assets | ||
| Cash and cash equivalents | 189,199 | 218,472 |
| Other financial assets | 301,321 | 207,423 |
| Accounts receivables | 2,951 | 4,093 |
| Other current assets | 19,306 | 19,382 |
| Total current assets | 512,777 | 449,370 |
| Non-current assets | ||
| Property, plant and equipment | 48,424 | 43,747 |
| Intangible assets | 1,506 | 1,523 |
| Right-of-use assets | 13,327 | 13,308 |
| Other non-current assets | 1,199 | 2,017 |
| Total non-current assets | 64,456 | 60,595 |
| Total assets | 577,233 | 509,965 |
| Liabilities and shareholders’ equity | ||
| Current liabilities | ||
| Provisions | 5,144 | — |
| Accounts payables | 22,095 | 25,206 |
| Deferred revenue | 68,928 | 100,401 |
| Liabilities for warrants | 14,765 | 18,993 |
| Lease liabilities | 2,825 | 2,604 |
| Other current liabilities | 15,155 | 9,348 |
| Total current liabilities | 128,912 | 156,552 |
| Non-current liabilities | ||
| Deferred revenue | 52,597 | 115,527 |
| Lease liabilities | 13,198 | 12,798 |
| Other non-current liabilities | — | 4 |
| Total non-current liabilities | 65,795 | 128,329 |
| Shareholders’ equity | ||
| Share capital | 1,031 | 847 |
| Share premium | 1,010,648 | 823,166 |
| Accumulated deficit | (626,938) | (597,293) |
| Other reserves | (2,215) | (1,636) |
| Total shareholders’ equity | 382,526 | 225,084 |
| Total liabilities and shareholders’ equity | 577,233 | 509,965 |
| Nine months ended | ||
| 2024 | 2023 | |
| (Euros in thousands) | ||
| Cash flows from operating activities | ||
| Net loss | (29,645) | (70,846) |
| Taxes on income | 7,720 | — |
| Loss before tax | (21,925) | (70,846) |
| Adjustments for: | ||
| Interest income | (18,185) | (8,993) |
| Depreciation and amortization | 9,149 | 5,432 |
| Interest expenses | 654 | 620 |
| Equity-settled share-based payment | 13,112 | 16,299 |
| Loss from disposal of fixed assets | 1 | |
| Net foreign exchange differences and expected credit losses | 4,018 | (760) |
| Change in fair value of liabilities for warrants | (4,228) | 7,103 |
| Changes in: | ||
| Decrease in accounts receivables | 1,142 | 596 |
| Decrease/(increase) in other assets | (2,623) | 658 |
| (Decrease) in deferred revenue, accounts payables and other liabilities | (91,113) | (15,641) |
| Interest received | 11,098 | 4,904 |
| Interest paid | (654) | (221) |
| Income tax paid | — | — |
| Net cash used in operating activities | (99,554) | (60,849) |
| Cash flows from investing activities | ||
| Payments for property, plant and equipment | (14,598) | (21,506) |
| Payments for intangible assets | (148) | (158) |
| Payments for investments classified in other financial assets | (356,596) | (299,018) |
| Proceeds from maturity of investments classified in other financial assets | 266,361 | 229,557 |
| Proceeds from disposal of property, plant and equipment | 1 | — |
| — | — | |
| Net cash used in investing activities | (104,980) | (91,125) |
| Cash flows from financing activities | ||
| Proceeds from issuance of shares to equity holders | 174,554 | 90,404 |
| Transaction costs deducted from equity | (2,039) | |
| Repayments related to lease liabilities | (1,228) | (2,877) |
| Net cash provided by financing activities | 173,326 | 85,488 |
| Net decrease in cash and cash equivalents | (31,208) | (66,486) |
| Cash and cash equivalents at beginning of the year | 218,472 | 148,519 |
| Effects of exchange rate changes, expected credit losses and accrued intereston cash and cash equivalents | 1,935 | 1,413 |
| Cash and cash equivalents at end of the year | 189,199 | 83,446 |
| (Euros in thousands) | Sharecapital | Sharepremium | Accumulateddeficit | Otherreserves | Totalshare-holders’equity |
| Balance as of | 767 | 714,177 | (500,299) | (1,481) | 213,164 |
| Other comprehensive income | — | — | — | 769 | 769 |
| Net loss | — | — | (70,846) | — | (70,846) |
| Comprehensive loss for the year | — | — | (70,846) | 769 | (70,077) |
| Equity-settled share-based compensation | — | 16,299 | — | — | 16,299 |
| Share options exercised | — | 140 | — | — | 140 |
| Issue of share capital – net of transaction costs | 80 | 88,145 | — | — | 88,225 |
| Balance as of | 847 | 818,761 | (571,145) | (712) | 247,751 |
| Balance as of | 847 | 823,166 | (597,293) | (1,636) | 225,084 |
| Other comprehensive income | — | — | — | (579) | (579) |
| Net loss | — | — | (29,645) | — | (29,645) |
| Comprehensive loss for the year | — | — | (29,645) | (579) | (30,224) |
| Equity-settled share-based compensation | — | 13,112 | — | — | 13,112 |
| Share options exercised | 1 | 1,113 | — | — | 1,114 |
| Issue of share capital – net of transaction costs | 183 | 173,257 | — | — | 173,440 |
| Balance as of | 1,031 | 1,010,648 | (626,938) | (2,215) | 382,526 |
1All amounts translated using the exchange rate published by the
Attachment
