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Immatics Announces Second Quarter 2022 Financial Results and Business Update

https://immatics.com/
https://immatics.com/
  • ACTengine® TCR-T cell therapy targeting PRAME is enrolling patients in all three Phase 1b cohorts: IMA203 monotherapy at provisional recommended Phase 2 dose (RP2D) (Cohort A), IMA203/nivolumab checkpoint inhibitor combination (Cohort B) and IMA203CD8 2nd generation monotherapy (Cohort C)

  • TCR Bispecific candidate TCER® IMA401 targeting MAGEA4/A8 Phase 1a clinical trial initiated in patients with recurrent and/or refractory solid tumors

  • New multi-program collaboration initiated with Bristol Myers Squibb to develop allogeneic TCR-T/CAR-T programs using Immatics’ proprietary ACTallo® platform; Immatics received $60 million upfront payment and is eligible for up to $700 million per program in milestone payments as well as tiered royalties

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  • Autologous TCR-T collaboration with Bristol Myers Squibb from 2019 expanded to include one additional target; Immatics received $20 million upfront payment and is eligible for milestone payments and royalties

  • CRISPR-based gene editing: Strategic research collaboration and licensing agreement with Editas Medicine, Inc. signed

  • Cash and cash equivalents as well as other financial assets of $337.0 million1 (€324.4 million) as of June 30, 2022, funding company operations into second half of 2024

Tuebingen, Germany and Houston, Texas, August 9, 2022Immatics N.V. (NASDAQ: IMTX, “Immatics”), a clinical-stage biopharmaceutical company active in the discovery and development of T cell-redirecting cancer immunotherapies, today reported financial results and provided a business update for the quarter ended June 30, 2022.

“Immatics has now initiated all three IMA203 TCR-T Phase 1b expansion cohorts with the objective to deliver durable objective responses in heavily pre-treated solid cancer patients. Our IMA203 TCR-T therapy as well as IMA402, our TCR Bispecific, both target a PRAME peptide which represents one of the most promising and prevalent targets in the solid cancer space,” commented Harpreet Singh, Ph.D., CEO and Co-Founder of Immatics. “We are also very excited to have recently announced two new agreements with Bristol Myers Squibb and Editas Medicine that strengthen our capabilities in the field of allogeneic gamma delta T cell therapies. By combining our strengths through such partnerships, we can accelerate the development of our pipeline and increase its potential to deliver a meaningful impact on the lives of cancer patients.”

Second Quarter 2022 and Subsequent Company Progress

Adoptive Cell Therapy Programs

  • ACTengine® IMA203 (PRAME) – Following interim results from the IMA203 monotherapy during Phase 1a dose escalation, Immatics has extended the clinical trial to three Phase 1b expansion cohorts to realize a high rate of durable responses with TCR-T against PRAME.

    • Cohort A – IMA203 as monotherapy at the provisional recommended Phase 2 dose (RP2D) plus exploration of a higher dose level (dose level 5, DL5; up to 4.7 billion transduced CD8 T cells per m² body surface area)

    • Cohort B – IMA203 in combination with the PD-1 immune checkpoint inhibitor Opdivo® (nivolumab)

    • Cohort C – IMA203CD8, a 2nd generation monotherapy where IMA203 is co-expressed with a CD8 co-receptor to leverage functional CD4 T cells in addition to CD8 T cells in the anti-tumor response

As per the respective announcements made in March and May, the first patients have been treated in Cohort A and Cohort B, with the first patient expected to be treated in Cohort C in August, 2022. The next data readout for the IMA203 monotherapy cohort at RP2D is expected for 2H 2022 and an initial data readout for Cohort B and Cohort C is planned for YE2022.

  • ACTallo® – On June 2nd, 2022, Immatics announced a multi-program collaboration with Bristol Myers Squibb to develop allogeneic TCR-T/CAR-T programs. Immatics received an upfront payment of $60 million and is eligible for up to $700 million per Bristol Myers Squibb program through milestone payments and tiered royalties. Under the collaboration agreement, Bristol Myers Squibb receives access to Immatics’ proprietary gamma delta T cell-derived allogeneic Adoptive Cell Therapy (ACT) platform, ACTallo®, and can bring in up to 4 TCR-T targets based on the 2019 collaboration agreement or CAR-T targets. Immatics receives access to Bristol Myers Squibb’s next-generation technologies. The companies will work together to develop and commercialize two of Bristol Myers Squibb’s allogeneic TCR-T/CAR-T programs. Under the terms of the collaboration, both companies have an option to develop up to four additional programs each. Immatics may also develop additional allogeneic programs based on its ACTallo® platform outside of the collaboration.

  • ACTallo® – Immatics entered a strategic research collaboration and licensing agreement with Editas Medicine, Inc., combining gamma delta T cell adoptive cell therapies and gene editing to develop medicines for the treatment of cancer. As part of the agreement, Immatics gains non-exclusive rights to Editas Medicine’s CRISPR technology and intellectual property.

  • Autologous TCR-T – Immatics and Bristol Myers Squibb expanded their autologous T cell receptor-based therapy (TCR-T) collaboration signed in 2019 by including one additional TCR-T target discovered by Immatics. Immatics received a payment of $20 million and is eligible for milestone payments as well as royalties.

  • ACTengine® IMA201 (MAGEA4/A8) – The Phase 1a dose escalation cohort is ongoing and is expected to be completed by YE2022.

TCR Bispecifics Programs

Immatics’ TCER® candidates are next-generation, half-life extended TCR Bispecific molecules designed to maximize efficacy while minimizing toxicities in patients through its proprietary format using a low-affinity T cell recruiter and a high-affinity TCR domain.

  • TCER® IMA401 (MAGEA4/8) – On May 10, 2022, Immatics announced the initiation of its Phase 1 trial evaluating the company’s most advanced T cell engaging receptor (TCER®) IMA401 in patients with recurrent and/or refractory solid tumors. The Phase 1 clinical trial is expected to include approximately 50 patients at up to 15 centers in Germany. IMA401 is developed in collaboration with Bristol Myers Squibb.

  • TCER® IMA402 (PRAME) – A preclinical data update will be presented at the European Society for Medical Oncology (ESMO) Annual Meeting (September 9-13, 2022). Manufacturing of the clinical batch is on track for 2H 2022 and initiation of the Phase 1 trial is planned in 2023.

Corporate Developments

Board of Directors Update

  • At Immatics’ Annual General Meeting in June 2022, Nancy Valente, M.D., was elected as a member of the company’s Board of Directors. Dr. Valente brings over 20 years of experience in oncology and hematology drug development. In her last position at Genentech/Roche, she was Senior Vice President, Oncology Product Development, where she helped to build a diverse portfolio of new oncology therapies encompassing small molecules, antibodies, bispecific antibodies and antibody drug conjugates. Additional information on all members of Immatics’ Board of Directors can be found on the Immatics website.

Second Quarter 2022 Financial Results

Cash Position: Cash and cash equivalents as well as other financial assets total €324.4 million ($337.0 million1) as of June 30, 2022, compared to €252.7 million ($262.5 million1) as of March 31, 2022. The increase is mainly due to the receipt of the upfront payment in connection with the collaboration agreement with Bristol Myers Squibb on allogeneic ACT as well as the addition of one additional autologous TCR-T target as part of a 2019 collaboration agreement, partly offset by the financing of our ongoing research and development activities. With the addition of these upfront payments, the Company projects a cash runway into 2H 2024.

Revenue: Total revenue, consisting of revenue from collaboration agreements, was €17.2 million ($17.9 million1) for the three months ended June 30, 2022, compared to €5.2 million ($5.4 million1) for the three months ended June 30, 2021. The increase is mainly related to the increased recognition of revenue for the multiple collaboration agreements Immatics has in place.

Research and Development Expenses: R&D expenses were €25.2 million ($26.2 million1) for the three months ended June 30, 2022, compared to €20.3 million ($21.1 million1) for the three months ended June 30, 2021. The increase is mainly related to increased spending on clinical trials.

General and Administrative Expenses: G&A expenses were €8.7 million ($9.0 million1) for the three months ended June 30, 2022, compared to €8.3 million ($8.6 million1) for the three months ended June 30, 2021.

Net Income/Loss: Net loss was €14.0 million ($14.5 million1) for the three months ended June 30, 2022, compared to a net loss of €26.5 million ($27.5 million1) for the three months ended June 30, 2021. The decrease was primarily the result of the increased revenue from multiple collaboration agreements.

Full financial statements can be found in the current report on Form 6-K filed with the Securities and Exchange Commission (SEC) and published on the SEC website under www.sec.gov.

1 All amounts translated using the exchange rate published by the European Central Bank in effect as of June 30, 2022 (1 EUR = 1.0387 USD).

Upcoming Investor Conferences

  • Jefferies Cell and Genetic Medicine Summit, New York – September 29-30, 2022

  • Jefferies London Healthcare Conference, London, U.K. – November 15-17, 2022

To see the full list of events and presentations, visit www.investors.immatics.com/events-presentations.

- END -

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.

For regular updates about Immatics, visit www.immatics.com. You can also follow us on Instagram, Twitter and LinkedIn.

Forward-Looking Statements:
Certain statements in this press release may be considered forward-looking statements. Forward-looking statements generally relate to future events or Immatics’ future financial or operating performance. For example, statements concerning the timing of product candidates and Immatics’ focus on partnerships to advance its strategy are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may”, “should”, “expect”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”, “potential” or “continue”, or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Immatics and its management, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Factors that may cause actual results to differ materially from current expectations include, but are not limited to, various factors beyond management's control including general economic conditions and other risks, uncertainties and factors set forth in filings with the SEC. Nothing in this presentation should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Immatics undertakes no duty to update these forward-looking statements. All the scientific and clinical data presented within this press release are – by definition prior to completion of the clinical trial and a clinical study report – preliminary in nature and subject to further quality checks including customary source data verification.

For more information, please contact:

Media and Investor Relations Contact

Jacob Verghese or Eva Mulder

Trophic Communications

Phone: +49 89 2070 89831 or +31 6 52 33 1579

immatics@trophic.eu


Immatics N.V.

 

Anja Heuer

Jordan Silverstein

Director, Corporate Communications

Head of Strategy

Phone: +49 89 540415-606

Phone: +1 281 810 7545

media@immatics.com

InvestorRelations@immatics.com

Unaudited Condensed Consolidated Statement of Financial Position of Immatics N.V.

 

 

 

 

As of

 

June 30,
2022

December 31,
2021

 

 

 

 

(Euros in thousands)

Assets

 

 

Current assets

 

 

Cash and cash equivalents

265,125

132,994

Other financial assets

59,253

12,123

Accounts receivable

961

682

Other current assets

10,686

6,408

 

 

 

Total current assets

336,025

152,207

Non-current assets

 

 

Property, plant and equipment

11,271

10,506

Intangible assets

1,309

1,315

Right-of-use assets

15,016

9,982

Other non-current assets

4,678

636

 

 

 

Total non-current assets

32,274

22,439

 

 

 

Total assets

368,299

174,646

 

 

 

Liabilities and shareholders’ equity

 

 

Current liabilities

 

 

Provisions

2,858

51

Accounts payable

13,284

11,624

Deferred revenue

78,394

50,402

Other financial liabilities

14,116

27,859

Lease liabilities

2,429

2,711

Other current liabilities

2,913

2,501

 

 

 

Total current liabilities

113,994

95,148

Non-current liabilities

 

 

Deferred revenue

115,321

48,225

Lease liabilities

13,984

7,142

Other non-current liabilities

59

68

 

 

 

Total non-current liabilities

129,364

55,435

Shareholders’ equity

 

 

Share capital

653

629

Share premium

593,026

565,192

Accumulated deficit

(466,131)

(537,813)

Other reserves

(2,607)

(3,945)

 

 

 

Total shareholders’ equity

124,941

24,063

 

 

 

Total liabilities and shareholders’ equity

368,299

174,646

 

 

 

Unaudited Condensed Consolidated Statement of Income/(Loss) of Immatics N.V.

 

 

 

 

 

 

Three months ended June 30,

Six months ended June 30,

 

2022

2021

2022

2021

 

(Euros in thousands, except
share and per share data)

(Euros in thousands, except
share and per share data)

Revenue from collaboration agreements

17,215

5,189

120,123

12,592

Research and development expenses

(25,216)

(20,340)

(50,360)

(43,389)

General and administrative expenses

(8,683)

(8,271)

(17,961)

(16,702)

Other income

27

26

32

265

 

 

 

 

 

Operating result

(16,657)

(23,396)

51,834

(47,234)

Financial income

7,015

213

8,774

3,101

Financial expenses

(407)

(629)

(1,524)

(1,277)

Change in fair value of warrant liabilities

(2,786)

(2,722)

13,743

(3,936)

 

 

 

 

 

Financial result

3,822

(3,138)

20,993

(2,112)

 

 

 

 

 

Profit/(loss) before taxes

(12,835)

(26,534)

72,827

     (49,346)

Taxes on income

(1,145)

(1,145)

Net profit/(loss)

(13,980)

(26,534)

71,682

(49,346)

 

 

 

 

 

Net profit/(loss) per share:

 

 

 

        

Basic

(0.22)

(0.42)

1.12

      (0.78)

Diluted

(0.22)

(0.42)

1.11

      (0.78)

Weighted average shares outstanding:

 

 

 

 

Basic

64,915,600

62,909,095

63,932,449

62,908,945

Diluted

64,915,600

62,909,095

64,477,256

62,908,945

Unaudited Condensed Consolidated Statement of Comprehensive Income/(Loss) of Immatics N.V.

 

Three months ended June 30,

Six months ended June 30,

 

2022

2021

2022

2021

 

(Euros in thousands)

(Euros in thousands)

Net profit/(loss)

(13,980)

    (26,534)

71,682

(49,346)

Other comprehensive income/(loss)

 

 

 

 

Items that may be reclassified subsequently to profit or loss, net of tax

 

 

 

 

Currency translation differences from foreign operations

778

    (1,401)

1,338

1,324

 

 

 

 

 

Total comprehensive income/(loss) for the period

(13,202)

    (27,935)

73,020

    (48,022)

 

 

 

 

 

Unaudited Condensed Consolidated Statement of Cash Flows of Immatics N.V.

 

 

 

 

Six months ended June 30,

 

        2022        

        2021        

 

 

 

 

(Euros in thousands)

Cash flows from operating activities

 

 

Net profit/(loss)

71,682

(49,346)

Adjustments for:

 

 

Interest income

(23)

(87)

Depreciation and amortization

3,407

2,264

Interest expense

538

140

Equity settled share-based payment

11,262

16,270

Net foreign exchange differences

115

236

Change in fair value of warrant liabilities

(13,743)

3,936

Changes in:

 

 

(Increase)/decrease in accounts receivable

(280)

532

(Increase)/decrease in other assets

(6,903)

902

Increase/(decrease) in accounts payable and other liabilities

98,078

(11,363)

Interest received

23

54

Interest paid

(434)

(140)

 

 

 

Net cash provided by/(used in) operating activities

163,722

       (36,602)

 

 

 

Cash flows from investing activities

 

 

Payments for property, plant and equipment

(1,965)

(1,912)

Cash paid for investments classified in Other financial assets

(59,253)

(11,423)

Cash received from maturity of investments classified in Other financial assets

12,695

3,411

Payments for intangible assets

(6)

(390)

Proceeds from disposal of property, plant and equipment

1

8

 

 

 

Net cash (used in)/provided by investing activities

(48,528)

       (10,306)

 

 

 

Cash flows from financing activities

 

 

Proceeds from issuance of shares to equity holders

17,112

Transaction costs deducted from equity

(515)

Payments for leases

(1,394)

   (1,348)

 

 

 

Net cash provided by/(used in) financing activities

15,203

   (1,348)

 

 

 

Net increase/(decrease) in cash and cash equivalents

130,397

  (48,256)

 

 

 

Cash and cash equivalents at beginning of period

132,994

     207,530

 

 

 

Effects of exchange rate changes on cash and cash equivalents

1,734

819

 

 

 

Cash and cash equivalents at end of period

265,125

   160,093

 

 

 

Unaudited 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, 2021

629

538,695

(444,478)

(7,459)

87,387

 

Other comprehensive income

1,324

1,324

 

Net loss

    (49,346)

 (49,346)

 

Comprehensive income/(loss) for the year

—  

—  

    (49,346)

1,324

 (48,022)

 

Equity-settled share-based compensation

16,270

16,270

 

 

 

 

 

 

 

 

Balance as of June 30, 2021

629

554,965

   (493,824)

(6,135)

55,635

 

 

 

 

 

 

 

 

Balance as of January 1, 2022

629

565,192

  (537,813)

(3,945)

24,063

 

Other comprehensive income

1,338

1,338

 

Net profit

71,682

71,682

 

Comprehensive income for the year

—  

—  

71,682

1,338

73,020

 

Equity-settled share-based compensation

11,262

11,262

 

Share options exercised

1

1

 

Issue of share capital – net of transaction costs

24

16,571

—   

16,595

 

 

 

 

 

 

 

 

Balance as of June 30, 2022

653

593,026

      (466,131)

(2,607)

124,941

 

 

 

 

 

 

 

 

 

Attachment