New Novartis Fabhalta® data show clinically meaningful and statistically significant proteinuria reduction of 38.3% versus placebo for patients with IgA nephropathy

  • APPLAUSE-IgAN is first and only Phase III study to demonstrate significant proteinuria reduction by targeting the complement system in patients with IgAN 1

  • IgAN is a heterogeneous, progressive, rare kidney disease and is a major cause of chronic kidney disease worldwide 2 ; complement activation is a key driver of glomerular inflammation in IgAN 3,4

  • There is a need for effective, targeted therapies for IgAN 2,5 ; up to 30% of patients with persistent proteinuria (≥1 g/day) may progress to kidney failure within 10 years, requiring maintenance dialysis and/or kidney transplantation 6

  • Novartis continues to advance broad renal portfolio in late-stage development, exploring the potential to slow disease progression and extend dialysis-free life

Novartis today presented results from a pre-specified interim analysis of the Phase III APPLAUSE-IgAN study of Fabhalta ® (iptacopan), an investigational Factor B inhibitor of the alternative complement pathway, in patients with IgA nephropathy (IgAN) 1 . In the analysis, patients treated with Fabhalta achieved a 38.3% (p

Proteinuria reduction is an increasingly recognized surrogate marker correlating with progression to kidney failure and has been used as an endpoint in IgAN clinical trials to support accelerated approvals 7 . The study also showed that Fabhalta was well tolerated with a favorable safety profile consistent with previously reported data 1,8 . Results were presented today during a late-breaking clinical trials session at the World Congress of Nephrology (WCN) in Buenos Aires, Argentina 1 .

"In IgAN, part of the immune system called the alternative complement pathway can become overly activated in the kidneys, which causes an inflammatory response, leading to progressive kidney damage and gradual loss of kidney function. The loss of kidney function, together with potential side effects of IgAN treatments available until recently, significantly impact patients' lives," said Professor Dana Rizk , Investigator and APPLAUSE-IgAN Steering Committee Member and professor in the UAB Division of Nephrology. "Fabhalta is the first potential treatment for IgAN that specifically targets the alternative complement pathway."

This pre-specified interim analysis included 250 patients for the efficacy analysis and 443 for the safety analysis 1 . The APPLAUSE-IgAN study continues in a double-blind fashion, and therefore only limited interim analysis results can be presented 9,10 . Submission for possible accelerated approval to the FDA was accepted and has received priority review. The primary endpoint evaluating Fabhalta's ability to slow IgAN progression by measuring the annualized total estimated glomerular filtration rate (eGFR) slope over 24 months is expected at study completion in 2025 9,10 .

"IgAN progresses over many years, and patients' needs may evolve such that different therapies may be best used at different times," said David Soergel , M.D., Global Head, Cardiovascular, Renal and Metabolism Development Unit, Novartis. "Our renal pipeline includes medicines with a variety of mechanisms which may allow them to be targeted to patients based on their clinical characteristics."

Other data presented at WCN include IgAN and C3 glomerulopathy (C3G) real-world studies. Novartis will be presenting further data from the renal portfolio at future medical meetings.

About APPLAUSE-IgAN
APPLAUSE-IgAN (NCT04578834) is a Phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of twice-daily oral Fabhalta (200 mg) in 518 adult primary IgAN patients 9,10 .

The two primary endpoints of the study for the interim and final analysis, respectively, are proteinuria reduction at 9 months as measured by UPCR, and the annualized total eGFR slope over 24 months 9,10 . At the time of final analysis, the following secondary endpoints will also be assessed: proportion of participants reaching UPCR 1.73 m 2 or maintenance dialysis or receipt of kidney transplant or death from kidney failure), change from baseline to 9 months in the fatigue scale measured by the Functional Assessment Of Chronic Illness Therapy-Fatigue questionnaire 9,10 .

The main study population enrolled patients with an eGFR ≥30 mL/min/ 1.73 m 2 and UPCR ≥1 g/g at baseline 9,10 . In addition, a smaller cohort of patients with severe renal impairment (eGFR 20–30 mL/min/ 1.73 m 2 at baseline) was also enrolled to provide additional information but will not contribute to the main efficacy analyses 9,10 .

About Fabhalta ® ( iptacopan )
Fabhalta (iptacopan) is an oral, Factor B inhibitor of the alternative complement pathway 1 .

Discovered at Novartis, Fabhalta is currently in development for a range of rare diseases including IgAN, C3G, atypical hemolytic uremic syndrome ( aHUS), immune complex membranoproliferative glomerulonephritis (IC-MPGN) and lupus nephritis (LN).

Fabhalta was approved by the FDA in December 2023 for the treatment of adults with the rare blood disorder paroxysmal nocturnal hemoglobinuria (PNH) and received a positive opinion from the CHMP of the EMA in March 2024 11,12 .

About IgA nephropathy (IgAN)
IgAN is a heterogeneous, progressive, rare kidney disease 2 . Each year, approximately 25 people per million worldwide are newly diagnosed with IgAN 13 .

Up to 30% of people who have IgAN with persistent higher levels of proteinuria (≥1 g/day) may progress to kidney failure within 10 years 6 . There is a need for effective, targeted therapies for IgAN that can help slow or prevent progression to kidney failure 2,5,14 .

Novartis commitment in renal
At Novartis, our journey in nephrology began more than 40 years ago when the development and introduction of cyclosporine helped reimagine the field of transplantation and immunosuppression. We continue today with the same bold ambition to transform the lives of people living with kidney diseases.

Through our renal portfolio, we are exploring potential therapeutic options to address the current unmet needs of people living with rare kidney diseases, including IgAN, C3G, aHUS, IC-MPGN and LN. New and innovative treatment options that target the underlying causes of rare kidney diseases may slow disease progression and help people live longer without the need for infusions, dialysis or transplantation.

IgAN is a heterogeneous disease presenting with a variety of clinical manifestations, phenotypes, and variable speeds of progression 2 . In addition to Fabhalta, Novartis is advancing the development of two other therapies in IgAN with highly differentiated mechanisms of action: atrasentan, an investigational oral endothelin A (ETA) receptor antagonist, and zigakibart, an investigational subcutaneously administered anti-APRIL monoclonal antibody, which are both in Phase III development 15,16 . Through our IgAN pipeline, we are committed to creating a portfolio of innovative medicines that improve and extend the lives of people living with kidney disease.

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "may," "could," "would," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis
Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people's lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide.

Reimagine medicine with us: Visit us at https://www.novartis.com and https://www.novartis.us and connect with us on LinkedIn , LinkedIn US , Facebook , X/Twitter , X/Twitter US , and Instagram .

References

  1. Perkovic V, Kollins D, Renfurm R, et al. Efficacy and Safety of Iptacopan in Patients with IgA Nephropathy: Interim Results from the Phase 3 APPLAUSE-IgAN Study. Presented at the World Congress of Nephrology (WCN); April 15, 2024 ; Buenos Aires, Argentina .
  2. Kidney Disease: Improving Global Outcomes (KDIGO) 2021 Clinical Practice Guideline for the Management of Glomerular Diseases. Kidney Int . 2021;100(4):S1-S276. doi:10.1016/j.kint.2021.05.021
  3. Rizk DV, Maillard N, Julian BA, et al. The Emerging Role of Complement Proteins as a Target for Therapy of IgA Nephropathy. Front Immunol . 2019;10:504. doi:10.3389/fimmu.2019.00504
  4. Medjeral-Thomas NR, O'Shaughnessy MM. Complement in IgA Nephropathy: The Role of Complement in the Pathogenesis, Diagnosis, and Future Management of IgA Nephropathy. Adv Chronic Kidney Dis . 2020;27(2):111-119. doi:10.1053/j.ackd.2019.12.004
  5. Boyd JK, Cheung CK, Molyneux K, Feehally J, Barratt J. An Update on the Pathogenesis and Treatment of IgA Nephropathy. Kidney Int . 2012;81(9):833-843. doi:10.1038/ki.2011.501
  6. Reich HN, Troyanov SAA, Scholey JW, Cattran DC. Remission of Proteinuria Improves Prognosis in IgA Nephropathy. J Am Soc Nephrol . 2007;18(12):3177-3183. doi:10.1681/ASN.2007050526
  7. Thompson A, Carroll K, Inker LA, et al. Proteinuria Reduction as a Surrogate End Point in Trials of IgA Nephropathy. Clin J Am Soc Nephrol . 2019;14(3):469-481. doi:10.2215/CJN.08600718
  8. Zhang H, Rizk DV, Perkovic V, et al. Results of a Randomized Double-Blind Placebo-Controlled Phase 2 Study Propose Iptacopan as an Alternative Complement Pathway Inhibitor for IgA Nephropathy. Kidney Int . 2024;105(1):189-199. doi:10.1016/j.kint.2023.09.027
  9. Rizk DV, Rovin BH, Zhang H, et al. Targeting the Alternative Complement Pathway with Iptacopan to Treat IgA Nephropathy: Design and Rationale of the APPLAUSE-IgAN Study. Kidney Int Rep . 2023;8(5):968-979. doi:10.1016/j.ekir.2023.01.041
  10. ClinicalTrials.gov. NCT04578834. A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase III Study to Evaluate the Efficacy and Safety of LNP023 in Primary IgA Nephropathy Patients. Available from: https://clinicaltrials.gov/ct2/show/NCT04578834 . Accessed April 2024 .
  11. Novartis. Novartis receives FDA approval for Fabhalta® (iptacopan), offering superior hemoglobin improvement in the absence of transfusions as the first oral monotherapy for adults with PNH. Available from: https://www.novartis.com/news/media-releases/novartis-receives-fda-approval-fabhalta-iptacopan-offering-superior-hemoglobin-improvement-absence-transfusions-first-oral-monotherapy-adults-pnh . Accessed April 2024 .
  12. Novartis. Novartis Fabhalta® (iptacopan) receives positive CHMP opinion as first oral monotherapy for adult patients with paroxysmal nocturnal hemoglobinuria (PNH). Available from: https://www.novartis.com/news/media-releases/novartis-fabhalta-iptacopan-receives-positive-chmp-opinion-first-oral-monotherapy-adult-patients-paroxysmal-nocturnal-hemoglobinuria-pnh . Accessed April 2024 .
  13. McGrogan A, Franssen CF, de Vries CS. The Incidence of Primary Glomerulonephritis Worldwide: A Systematic Review of the Literature. Nephrol Dial Transplant . 2011;26(2):414-430. doi:10.1093/ndt/gfq665
  14. Xie J, Kiryluk K, Wang W, et al. Predicting Progression of IgA Nephropathy: New Clinical Progression Risk Score. PLoS ONE. 2012;7(6):e38904. doi:10.1371/journal.pone.0038904
  15. Novartis. Novartis completes acquisition of Chinook Therapeutics. Available from: https://www.novartis.com/news/media-releases/novartis-completes-acquisition-chinook-therapeutics . Accessed April 2024 .
  16. Novartis. Novartis investigational atrasentan Phase III study demonstrates clinically meaningful and highly statistically significant proteinuria reduction in patients with IgA nephropathy (IgAN). Available from: https://www.novartis.com/news/media-releases/novartis-investigational-atrasentan-phase-iii-study-demonstrates-clinically-meaningful-and-highly-statistically-significant-proteinuria-reduction-patients-iga-nephropathy-igan . Accessed April 2024 .

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Immatics Announces First Quarter 2024 Financial Results and Business Update

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 (€564.0 million) as of March 31, 2024 funding company operations into 2027

Houston, Texas and Tuebingen, Germany, May 14, 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 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

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 .

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 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, 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

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 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 €564.0 million ($609.7 million 1 ) as of March 31, 2024, compared to €425.9 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 €30.3 million ($32.8 million 1 ) for the three months ended March 31, 2024, compared to €9.8 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 €32.1 million ($34.7 million 1 ) for the three months ended March 31, 2024, compared to €27.6 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 €11.6 million ($12.5 million 1 ) for the three months ended March 31, 2024, compared to €9.6 million ($10.4 million 1 ) for the three months ended March 31, 2023.

Net Profit and Loss: Net loss was €3.1 million ($3.4 million 1 ) for the three months ended March 31, 2024, compared to a net loss of €19.7 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 .

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 .

- 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 CD8αβ 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 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, 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


Immatics N.V.
Jordan Silverstein
Head of Strategy
Phone: +1 346 319-3325
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,
2024

December 31,
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.

(Euros in thousands)

Share
capital

Share
premium

Accumulated
deficit

Other
reserves

Total
share-
holders'
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

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