Immatics Announces Full Year 2023 Financial Results and Corporate Update
- 50% confirmed objective response rate reported for ACTengine® IMA203 GEN1 in melanoma
- Registration-enabling Phase 2/3 trial planned for 2L+ melanoma in 2024
- Financially, $201.5 million public offering completed in January 2024
- Cash and cash equivalents of $470.6 million as of December 31, 2023, projecting a cash runway into 2027
- None.
Insights
The interim clinical data update on ACTengine® IMA203 GEN1 in melanoma presents a significant milestone with a 50% confirmed objective response rate and a median duration of response not reached at a median follow-up of 14.4 months. This suggests a potentially promising treatment for melanoma patients, especially considering the well-tolerated profile of IMA203. The plan to initiate a registration-enabling Phase 2/3 trial in 2024 for IMA203 GEN1 in second-line or later melanoma is an important step towards potential FDA approval and commercialization. The inclusion of uveal melanoma patients could expand the therapeutic reach of the drug, addressing an unmet medical need.
From an oncological perspective, the high prevalence of PRAME in cutaneous melanoma and the decision to potentially forgo PRAME pre-testing could streamline the clinical trial process. However, the lack of a companion diagnostic could raise concerns about the precision medicine approach and whether all enrolled patients would benefit from the therapy. The success of the trial will hinge on the interim readout and overall survival data, which are critical endpoints for accelerated and full FDA approval, respectively.
Immatics' financial health, as reported in the full year 2023 financial results, appears robust with a cash position of €425.9 million and a projected cash runway into 2027. This is bolstered by the $201.5 million public offering and strategic collaborations with Bristol Myers Squibb and Moderna, which include substantial upfront payments and potential milestone payments. These collaborations not only provide immediate financial benefits but also validate Immatics' technology and pipeline.
The financial implications for stakeholders are promising in the short term due to the inflow of capital and the partnerships' potential to expedite drug development. However, the long-term financial outlook will depend on the successful progression of clinical trials and eventual product commercialization. It is noteworthy that the decrease in total revenue in 2023 compared to 2022 is attributed to a one-time revenue from the previous year, which investors should consider when evaluating year-over-year performance.
The strategic collaboration between Immatics and Moderna, along with the equity investment and option exercise by Bristol Myers Squibb, indicate a strong industry interest in Immatics' proprietary technology platforms. This could position Immatics favorably in the competitive landscape of cancer immunotherapies. The focus on T cell-redirecting therapies, including TCR-T cell therapies and TCR Bispecifics, aligns with current market trends towards personalized and targeted cancer treatments.
Moreover, the expansion of Immatics' clinical footprint to include ovarian and uterine cancers represents a strategic move to capture a larger segment of the oncology market. The company's manufacturing capabilities and the recent completion of a new facility may provide it with the necessary infrastructure to meet future commercial demand, assuming successful trial outcomes. However, the market will be closely monitoring the upcoming clinical data updates planned for the second half of 2024, which will likely have a significant impact on Immatics' valuation and market positioning.
- Interim clinical data update on ACTengine® IMA203 GEN1 (PRAME) in melanoma at RP2D in November 2023:
50% confirmed objective response rate with median duration of response not reached at median follow-up of 14.4 months; IMA203 was well tolerated - Registration-enabling randomized Phase 2/3 trial for ACTengine® IMA203 GEN1 in 2L+ melanoma planned to begin in 2024
- Next data update on IMA203 GEN1 and IMA203CD8 GEN2 planned for 2H 2024
- First clinical data updates for Immatics’ next-generation 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
- In May 2023, Bristol Myers Squibb exercised first opt-in into the autologous cell therapy collaboration (
$15 million option fee received) and made a$35 million equity investment in July 2023 - In September 2023, Immatics and Moderna announced a strategic multi-platform collaboration to develop innovative oncology therapeutics; Immatics received
$120 million upfront payment, and the total deal volume could exceed$1.7 billion $201.5 million public offering completed on January 22, 2024- Cash and cash equivalents as well as other financial assets amount to
$470.6 million 1 (€425.9 million ) as of December 31, 2023. Addition of proceeds from the public offering in January 2024 results in projected cash runway into 2027
Houston, Texas and Tuebingen, Germany, March 21, 2024 – 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 and full year ended December 31, 2023.
“Immatics kicked off 2024 with a successful capital raise, providing significant financial runway and additional momentum to advance our ongoing clinical cell therapy and bispecific trials,” said Harpreet Singh, Ph.D., CEO and Co-Founder of Immatics. “We are striving to reach multiple relevant milestones this year, including announcing clinical proof-of-concept for our half-life extended TCR Bispecifics platform. In parallel, the clinical data for our PRAME cell therapy, IMA203 GEN1, in conjunction with highly constructive FDA discussions, reinforces our confidence in advancing this asset toward a registration-enabling Phase 2/3 clinical trial in melanoma, while laying the groundwork to transition into a fully equipped commercial-stage company.”
Full Year 2023 and Subsequent Company Progress
ACTengine® IMA203 (PRAME)
Clinical development plan update for ACTengine® IMA203 GEN1 and IMA203CD8 GEN2 monotherapies
Following an RMAT designation in October 2023 and productive interactions with the FDA, Immatics plans to initiate a registration-enabling randomized Phase 2/3 trial in 2024 for IMA203 GEN1 in patients with second-line or later (2L+) cutaneous melanoma, potentially including also uveal melanoma patients.
Immatics intends to assess IMA203 GEN1 targeting PRAME in HLA-A*02:01-positive cutaneous melanoma patients versus a control arm. This single trial will be designed to support accelerated approval based on an interim readout and full approval based on overall survival. The high prevalence of PRAME (≥
For IMA203CD8 GEN2, Immatics cleared dose level 4a (DL4a, up to ~1.6x109 TCR-T cells) in December 2023, which is currently intended to be the target 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 both Phase 1b cohorts with IMA203 GEN1 and IMA203CD8 GEN2 is planned for 2H 2024.
Manufacturing capabilities
Immatics’ late-stage clinical cell therapy development is supported by its streamlined manufacturing timeline, capabilities and facility. IMA203 GEN1 and IMA203CD8 GEN2 cell therapy products are manufactured within 7 days followed by a 7-day QC release testing at a success rate of >
Interim clinical data update on ACTengine® IMA203 GEN1 and IMA203CD8 GEN2 monotherapies, as of November 2023
On November 8, 2023, Immatics provided an interim clinical update from the ongoing Phase 1 trial with ACTengine® IMA203 targeting PRAME in patients with recurrent and/or refractory solid cancers (data cut-off September 30, 2023). The update was focused on IMA203 GEN1 in melanoma patients at the recommended Phase 2 dose (RP2D, 1.0-10x109 total TCR-T cells) and the first clinical data for IMA203CD8 GEN2.
Treatment with IMA203 GEN1 monotherapy (consisting of PRAME-specific functional CD8+ cells) in Phase 1a and Phase 1b Cohort A at RP2D demonstrated durable objective responses in melanoma patients with one patient exceeding 12 months and two patients exceeding 15 months post infusion and a
In addition, the first data on the company’s second-generation product candidate IMA203CD8 (consisting of PRAME-specific functional CD8+ and CD4+ cells) demonstrated
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 already 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 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. First clinical data in at least 25 patients in dose escalation across multiple solid cancers is expected to be announced in 2H 2024.
- TCER® IMA402 (PRAME) – 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 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 with a CDMO 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 . - In January 2024, Immatics hired Jason Braun as Senior Vice President Commercial to support the company as it transitions into a fully equipped commercial-stage entity and targets the initiation of a registration-enabling Phase 2/3 trial for its PRAME TCR-T cell therapy. Jason Braun joins the company with more than 20 years of experience in the biotech and pharma industry, having worked with several biopharmaceutical companies including Amgen, Dendreon, Pharmacyclics (Abbvie), Kite (Gilead) and Nkarta, among others. During his career, he has established a successful track record in the commercialization of oncology drug candidates.
- On September 11, 2023, Immatics announced a strategic multi-platform collaboration with Moderna, combining Immatics’ target and TCR platforms with Moderna’s cutting-edge mRNA technology. The collaboration spans various therapeutic modalities including bispecifics, cell therapy and cancer vaccines. Under the terms of the agreement, Immatics received an upfront payment of
$120 million . In addition, Immatics will receive research funding and is eligible to receive development, regulatory and commercial milestone payments that could exceed$1.7 billion . - On July 24, 2023, Bristol Myers Squibb made a
$35 million equity investment in Immatics, purchasing 2,419,818 ordinary shares in a private placement transaction at a subscription price per share of$14.46 . - In May 2023, 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.
Full Year 2023 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
General and Administrative Expenses: G&A expenses were
Net Profit and Loss: Net loss was
Full financial statements can be found in the Annual Report on Form 20-F filed with the Securities and Exchange Commission (SEC) and published on the SEC website under 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.
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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 as a means of disclosing material non-public information. For regular updates you can also follow us on X, 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 the Company’s future financial or operating performance. For example, statements concerning timing of data read-outs for product candidates, the timing and outcome 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, 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 |
| Immatics N.V. | |
| Sabrina Schecher, Ph.D. | |
| Senior Director, Investor Relations | |
| Phone: +1 346 319-3325 | |
| InvestorRelations@immatics.com |
Immatics N.V. and subsidiaries
Condensed Consolidated Statement of Profit/(Loss) of Immatics N.V.
| Year ended December 31, | |||
| 2023 | 2022 | 2021 | |
| (Euros in thousands, except per share data) | |||
| Revenue from collaboration agreements | 53,997 | 172,831 | 34,763 |
| Research and development expenses | (118,663) | (106,779) | (87,574) |
| General and administrative expenses | (38,198) | (36,124) | (33,808) |
| Other income | 1,139 | 26 | 325 |
| Operating result | (101,725) | 29,954 | (86,294) |
| Change in fair value of liabilities for warrants | (2,079) | 10,945 | (10,990) |
| Other financial income | 13,850 | 9,416 | 5,675 |
| Other financial expenses | (7,040) | (8,279) | (1,726) |
| Financial result | 4,731 | 12,082 | (7,041) |
| Profit/(loss) before taxes | (96,994) | 42,036 | (93,335) |
| Taxes on income | — | (4,522) | — |
| Net profit/(loss) | (96,994) | 37,514 | (93,335) |
| Net profit/(loss) per share: | |||
| Basic | (1.20) | 0.56 | (1.48) |
| Diluted | (1.20) | 0.55 | (1.48) |
Immatics N.V. and subsidiaries
Condensed Consolidated Statement of Comprehensive Loss of Immatics N.V.
| Year ended December 31, | |||
| 2023 | 2022 | 2021 | |
| (Euros in thousands) | |||
| Net profit/(loss) | (96,994) | 37,514 | (93,335) |
| Other comprehensive income/(loss) | |||
| Items that may be reclassified subsequently to profit or loss | |||
| Currency translation differences from foreign operations | (155) | 2,464 | 3,514 |
| Total comprehensive income/(loss) for the year | (97,149) | 39,978 | (89,821) |
Immatics N.V. and subsidiaries
Condensed Consolidated Statement of Financial Position of Immatics N.V.
| As of | ||
| December 31, 2023 | December 31, 2022 | |
| (Euros in thousands) | ||
| Assets | ||
| Current assets | ||
| Cash and cash equivalents | 218,472 | 148,519 |
| Other financial assets | 207,423 | 213,686 |
| Accounts receivables | 4,093 | 1,111 |
| Other current assets | 19,382 | 13,838 |
| Total current assets | 449,370 | 377,154 |
| Non-current assets | ||
| Property, plant and equipment | 43,747 | 13,456 |
| Intangible assets | 1,523 | 1,632 |
| Right-of-use assets | 13,308 | 13,033 |
| Other non-current assets | 2,017 | 2,545 |
| Total non-current assets | 60,595 | 30,666 |
| Total assets | 509,965 | 407,820 |
| Liabilities and shareholders’ equity | ||
| Current liabilities | ||
| Accounts payables | 25,206 | 13,056 |
| Deferred revenue | 100,401 | 64,957 |
| Liabilities for warrants | 18,993 | 16,914 |
| Lease liabilities | 2,604 | 2,159 |
| Other current liabilities | 9,348 | 9,366 |
| | ||
| Total current liabilities | 156,552 | 106,452 |
| Non-current liabilities | ||
| Deferred revenue | 115,527 | 75,759 |
| Lease liabilities | 12,798 | 12,403 |
| Other non-current liabilities | 4 | 42 |
| Total non-current liabilities | 128,329 | 88,204 |
| Shareholders’ equity | ||
| Share capital | 847 | 767 |
| Share premium | 823,166 | 714,177 |
| Accumulated deficit | (597,293) | (500,299) |
| Other reserves | (1,636) | (1,481) |
| Total shareholders’ equity | 225,084 | 213,164 |
| Total liabilities and shareholders’ equity | 509,965 | 407,820 |
Immatics N.V. and subsidiaries
Condensed Consolidated Statement of Cash Flows of Immatics N.V.
| Year ended December 31, | |||
| 2023 | 2022 | 2021 | |
| (Euros in thousands) | |||
| Cash flows from operating activities | |||
| Net profit/(loss) | (96,994) | 37,514 | (93,335) |
| Taxes on income | — | 4,522 | — |
| Profit/(loss) before tax | (96,994) | 42,036 | (93,335) |
| Adjustments for: | |||
| Interest income | (13,845) | (2,476) | (133) |
| Depreciation and amortization | 7,234 | 6,967 | 5,260 |
| Interest expenses | 831 | 1,038 | 566 |
| Equity-settled share-based payment | 20,705 | 22,570 | 26,403 |
| Net foreign exchange differences and expected credit losses | 6,861 | 2,953 | (2,408) |
| Change in fair value of liabilities for warrants | 2,079 | (10,945) | 10,990 |
| (Gains)/losses from disposal of fixed assets | (150) | — | — |
| Changes in: | |||
| (Increase)/decrease in accounts receivables | (2,982) | (429) | 569 |
| Decrease/(Increase) in other assets | (1,387) | (7,872) | (483) |
| Increase/(decrease) in deferred revenue, accounts payables and other liabilities | 85,999 | 45,559 | (31,784) |
| Interest received | 10,167 | 1,649 | 175 |
| Interest paid | (290) | (695) | (566) |
| Income tax paid | — | (224) | — |
| Net cash provided by/(used in) operating activities | 18,228 | 100,131 | (84,746) |
| Cash flows from investing activities | |||
| Payments for property, plant and equipment | (30,799) | (5,738) | (5,106 ) |
| Payments for intangible assets | (158) | (477) | (551) |
| Proceeds from disposal of property, plant and equipment | 150 | 52 | — |
| Payments for investments classified in Other financial assets | (415,325) | (216,323) | (11,298) |
| Proceeds from maturity of investments classified in Other financial assets | 414,744 | 12,695 | 24,448 |
| Net cash (used in)/provided by investing activities | (31,388) | (209,791) | 7,493 |
| Cash flows from financing activities | |||
| Proceeds from issuance of shares to equity holders | 90,404 | 134,484 | 94 |
| Transaction costs deducted from equity | (2,039) | (7,931) | — |
| Repayment of lease liabilities | (3,849) | (2,843) | (2,707) |
| Net cash provided by/(used in) financing activities | 84,516 | 123,710 | (2,613) |
| Net increase/(decrease) in cash and cash equivalents | 71,356 | 14,050 | (79,866) |
| Cash and cash equivalents at beginning of the year | 148,519 | 132,994 | 207,530 |
| Effects of exchange rate changes and expected credit losses on cash and cash equivalents | (1,403) | 1,475 | 5,330 |
| Cash and cash equivalents at end of the year | 218,472 | 148,519 | 132,994 |
Immatics N.V. and subsidiaries
Condensed Consolidated Statement of Changes in Shareholders’ equity (deficit) of Immatics N.V.
| (Euros in thousands) | Share capital | Share premium | Accumulated deficit | Other reserves | Total share- holders’ equity |
| Balance as of January 1, 2021 | 629 | 538,695 | (444,478) | (7,459) | 87,387 |
| Other comprehensive income | — | — | — | 3,514 | 3,514 |
| Net loss | — | — | (93,335) | — | (93,335) |
| Comprehensive loss for the year | — | — | (93,335) | 3,514 | (89,821) |
| Equity-settled share-based compensation | — | 26,403 | — | — | 26,403 |
| Share options exercised | — | 94 | — | — | 94 |
| Balance as of December 31, 2021 | 629 | 565,192 | (537,813) | (3,945) | 24,063 |
| Balance as of January 1, 2022 | 629 | 565,192 | (537,813) | (3,945) | 24,063 |
| Other comprehensive income | — | — | — | 2,464 | 2,464 |
| Net profit | — | — | 37,514 | — | 37,514 |
| Comprehensive income for the year | — | — | 37,514 | 2,464 | 39,978 |
| Equity-settled share-based compensation | — | 22,570 | — | — | 22,570 |
| Share options exercised | — | 311 | — | — | 311 |
| Issue of share capital – net of transaction costs | 138 | 126,104 | — | — | 126,242 |
| Balance as of December 31, 2022 | 767 | 714,177 | (500,299) | (1,481) | 213,164 |
| Balance as of January 1, 2023 | 767 | 714,177 | (500,299) | (1,481) | 213,164 |
| Other comprehensive loss | — | — | — | (155) | (155) |
| Net loss | — | — | (96,994) | — | (96,994) |
| Comprehensive loss for the year | — | — | (96,994) | (155) | (97,149) |
| Equity-settled share-based compensation | — | 20,705 | — | — | 20,705 |
| Share options exercised | — | 139 | — | — | 139 |
| Issue of share capital – net of transaction costs | 80 | 88,145 | — | — | 88,225 |
| Balance as of December 31, 2023 | 847 | 823,166 | (597,293) | (1,636) | 225,084 |
1 All amounts translated using the exchange rate published by the European Central Bank in effect as of December 31, 2023 (1 EUR = 1.105 USD).
Attachment
FAQ
What was the confirmed objective response rate reported for ACTengine® IMA203 GEN1 in melanoma?
When is the registration-enabling Phase 2/3 trial for 2L+ melanoma planned to begin?
What was the total amount raised in the public offering completed in January 2024?
What was the cash and cash equivalents total as of December 31, 2023?
What is the projected cash runway based on the cash and cash equivalents as of December 31, 2023?
