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InflaRx Reports Second Quarter 2022 Financial & Operating Results

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InflaRx N.V.
InflaRx N.V.
  • Fast Track and Orphan Drug designation for vilobelimab in pyoderma gangrenosum (PG) granted by the FDA

  • Plans to submit EUA with the FDA for vilobelimab in critically ill COVID-19 patients announced

  • Grant income of €14.4 million realized during the second quarter

  • Cash, cash equivalents and marketable securities of €91.8 million, expected to finance operations until year-end 2024

JENA, Germany, Aug. 05, 2022 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today financial and operating results for the three and six months ended June 30, 2022.

“We have made strong progress in recent months in advancing our strategy for vilobelimab,” said Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx. “Following positive Phase IIa data and productive discussions with the FDA, we are finalizing the design of our Phase III trial in PG. Our discussions with the FDA related to vilobelimab for the treatment of critically ill, invasively mechanically ventilated COVID-19 patients following the results from our Phase III trial were encouraging. Based on this, we are preparing to apply for emergency use authorization in the U.S. and expect to complete the submission by the end of the third quarter this year. We are also looking forward to further discussing in greater detail our vilobelimab results in critically ill COVID-19 patients with the regulatory agencies in Europe to understand next steps towards a potential submission for marketing authorization. It is a busy time at InflaRx, and we are excited to be moving our programs forward with the goal of ultimately helping patients in need of more effective treatments."

Dr. Thomas Taapken, Chief Financial Officer of InflaRx, said: “We are well financed to follow through with the next steps of our development programs after sharpening our strategic focus, which we announced in May. We are also grateful for the grant of up to €43.7 million from the German federal government for the clinical development of vilobelimab in COVID-19 and the development of the manufacturing process of vilobelimab. Through this strong backing and our focused development strategy, we believe that we have been able to significantly extend our cash runway to YE 2024 in this challenging market environment.”

Recent Corporate and R&D Highlights

Development of Vilobelimab in Pyoderma Gangrenosum (PG):
InflaRx recently reported that vilobelimab was granted orphan drug designation for the treatment of PG by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). In addition, the Company had a productive End-of-Phase II meeting with the FDA related to its plans for a Phase III development program in PG. The FDA indicated its support for a randomized, controlled Phase III development program during the meeting and offered to review the study protocol, recognizing PG as a serious and rare condition. Based on the FDA’s feedback and recommendations, InflaRx is now finalizing the design for a Phase III trial and continues to be in dialogue with the FDA related to this. Moreover, the FDA has granted Fast Track designation for the development of vilobelimab for the treatment of ulcerative PG. The Company had submitted a request for Fast Track designation to the FDA on the basis of previously reported positive outcome data from its Phase IIa open-label dose-escalation study in PG.

Development of Vilobelimab in Critically Ill COVID-19 Patients:
InflaRx recently announced its plans to submit a request for emergency use authorization (EUA) following encouraging interactions with the FDA at a recently held Type B meeting. As previously announced, the Company had requested the meeting to discuss a potential EUA submission and the development of its first-in-class anti-C5a monoclonal antibody vilobelimab in critically ill, invasively mechanically ventilated COVID-19 patients. In the meeting with the FDA, the Company discussed in detail the completed Phase III part of the PANAMO study and obtained guidance from the agency on deliverables related to its planned submission for EUA. InflaRx committed to submitting the request for an EUA by the end of the third quarter 2022 and is dedicated to achieving that ambitious goal. The Company had previously announced encouraging topline results from the PANAMO Phase III study, an international, double-blind, placebo-controlled, randomized clinical trial investigating vilobelimab in invasively mechanically ventilated COVID-19 patients. The primary efficacy endpoint was 28-day all-cause mortality. In this trial, vilobelimab treatment resulted in a 23.9% relative reduction in 28-day all-cause mortality compared to the placebo arm in the global data set (n=368 patients). A pre-specified analysis of patients from Western European countries (n=209) showed a 43% relative reduction in 28-day all-cause mortality in the vilobelimab treatment arm compared to placebo.

Development of Vilobelimab in Cutaneous Squamous Cell Carcinoma (cSCC):
In 2021, InflaRx started treating patients in an open-label, multicenter Phase II study evaluating vilobelimab alone and in combination with pembrolizumab in patients with programmed cell death protein 1 (PD-1) or programmed cell death ligand 1 (PD-L1) inhibitor resistant/refractory locally advanced or metastatic cSCC. To date, InflaRx has recruited nine patients in Arm A of this study (vilobelimab alone). Interim clinical data are expected in the second half of 2022. Arm B of this study (vilobelimab plus pembrolizumab) has enrolled nine patients so far in the first two dose groups. The interim analysis of Arm B is expected once ten patients treated at the dose level recommended by the independent Steering Committee are evaluable for response assessment. These data, which are required to move to the second stage of the Phase II trial, are expected to be available in the second half of 2023.

INF904 – Small Molecule C5aR Inhibitor:
InflaRx expects to initiate a Phase I program in the second half of 2022 and plans to study INF904 in complement-mediated, chronic autoimmune and inflammatory diseases where oral administration is the preferred choice for patients.

Financial Highlights – Q2 2022 

Research and Development Expenses 

Research and development expenses incurred for the six months ended June 30, 2022 increased compared to the corresponding period in 2021 by €5.4 million to €21.7 million. This increase was primarily due to higher expenses for the Phase III part of the COVID-19 trial as well as costs for manufacturing development activities and was driven by an overall increase in third-party expenses of €4.3 million.

General and Administrative Expenses 

General and administrative expenses increased by €3.0 million to €8.7 million for the six months ended June 30, 2022, from €5.7 million for the six months ended June 30, 2021. This increase is primarily attributable to higher expenses associated with equity-settled share-based compensation recognized in personnel expenses. Furthermore, legal, consulting and other expenses increased by €2.0 million to €4.2 million for the six months ended June 30, 2022, from €2.2 million, mainly due to consulting, implementation and testing costs of the internal control over financial reporting (ICFR) environment.

Other income

Other income for the six months ended June 30, 2022 amounted to €14.4 million. This was attributable to income recognized from grant payments received from the German federal government for the development of vilobelimab in COVID-19, including expenses related to clinical development and manufacturing process development.

Net Financial Result 

Net financial result increased by €1.4 million to €2.4 million for the six months ended June 30, 2022, from €1.0 million for the six months ended June 30, 2021. This increase was mainly attributable to lower foreign exchange losses which decreased by €1.4 million.

Net Loss 

Net loss for the six months ended June 30, 2022 was €13.5 million, compared to €20.9 million for the six months ended June 30, 2021.

Net Cash Used in Operating Activities 

Net cash used in operating activities increased by €7.1 million to €25.4 million for the six months ended June 30, 2022 compared to the six months ended June 30, 2021, during which net cash used in operating activities was €18.3 million.

Cash, Cash Equivalents and Marketable Securities

On June 30, 2022, the Company’s total funds available were approximately €91.8 million, composed of cash and cash equivalents of €15.4 million and marketable securities of €76.4 million. These funds are expected to finance operations until year-end 2024.

Additional information regarding these results and other relevant information is included in the notes to the unaudited interim condensed consolidated financial statements as of June 30, 2022, and the three and six months ended June 30, 2022 and 2021, as well as the consolidated financial statements as of and for the year ended December 31, 2021 in “ITEM 18. Financial Statements,” in InflaRx’s Annual Report on Form 20-F for the year ended December 31, 2021 as filed with the U.S. Securities and Exchange Commission (SEC). 

InflaRx N.V. and subsidiaries

Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and six months ended June 30, 2022 and 2021

 

For the three months ended
June 30,

 

For the six months ended
June 30,

(in €, except for share data)

2022
(unaudited)

 

2021
(unaudited)

 

2022
(unaudited)

 

2021
(unaudited)

 

 

 

 

 

Operating Expenses

 

 

 

 

Research and development expenses

(11,180,958

)

 

(11,299,270

)

 

(21,652,881

)

 

(16,206,155

)

General and administrative expenses

(4,346,965

)

 

(2,697,839

)

 

(8,734,408

)

 

(5,720,177

)

Total Operating Expenses

(15,527,923

)

 

(13,997,109

)

 

(30,387,289

)

 

(21,926,332

)

Other income

14,441,541

 

 

15,216

 

 

14,443,135

 

 

20,678

 

Other expenses

(279

)

 

(279

)

 

(844

)

 

(844

)

Operating Result

(1,086,661

)

 

(13,982,172

)

 

(15,944,999

)

 

(21,906,498

)

Finance income

82,401

 

 

35,622

 

 

110,362

 

 

58,584

 

Finance expenses

(7,945

)

 

(3,050

)

 

(32,531

)

 

(6,734

)

Foreign exchange result

1,563,580

 

 

(826,303

)

 

2,291,513

 

 

905,367

 

Other financial result

(86,000

)

 

(5,000

)

 

39,000

 

 

43,000

 

Income Taxes

 

 

 

 

 

 

 

Income (Loss) for the Period

465,376

 

 

(14,780,903

)

 

(13,536,654

)

 

(20,906,280

)

 

 

 

 

 

Share Information

 

 

 

 

Weighted average number of shares outstanding

44,203,763

 

 

44,186,279

 

 

44,203,763

 

 

39,024,533

 

Income (Loss) per share (basic/diluted)

0.01

 

 

(0.33

)

 

(0.31

)

 

(0.54

)

 

 

 

 

 

Loss for the Period

465,376

 

 

(14.780.903

)

 

(13,536,654

)

 

(20,906,280

)

Other comprehensive income (loss) that may be reclassified to profit or loss in subsequent periods:

 

 

 

 

Exchange differences on translation of foreign currency

4,408,940

 

 

(1,427,302

)

 

5,718,815

 

 

2,077,397

 

Total Comprehensive Income (Loss)

4,874,316

 

 

(16,208,205

)

 

(7,817,839

)

 

(18,828,883

)

 

 

 

 

 

InflaRx N.V. and subsidiaries

Unaudited Condensed Consolidated Statements of Financial Position as of June 30, 2022 and December 31, 2021

in €

June 30, 2022
(unaudited)

 

 

December 31, 2021

 

 

 

 

ASSETS

 

 

Non-current assets

 

 

Property and equipment

231,133

 

 

274,373

 

Right-of-use assets

1,506,039

 

 

1,408,078

 

Intangible assets

187,218

 

 

235,216

 

Other assets

341,666

 

 

336,566

 

Financial assets

237,412

 

 

27,206,990

 

Total non-current assets

2,503,468

 

 

29,461,224

 

Current assets

 

 

Current other assets

10,130,597

 

 

10,983,458

 

Current tax assets

1,518,072

 

 

1,282,177

 

Financial assets from government grants

8,260,503

 

 

 

Other financial assets

76,804,249

 

 

57,162,266

 

Cash and cash equivalents

15,416,152

 

 

26,249,995

 

Total current assets

112,129,573

 

 

95,677,896

 

TOTAL ASSETS

114,633,041

 

 

125,139,120

 

 

 

 

EQUITY AND LIABILITIES

 

 

Equity

 

 

Issued capital

5,304,452

 

 

5,304,452

 

Share premium

280,310,744

 

 

280,310,744

 

Other capital reserves

35,259,689

 

 

30,591,209

 

Accumulated deficit

(227,512,333

)

 

(213,975,679

)

Other components of equity

8,769,086

 

 

3,050,270

 

Total equity

102,131,638

 

 

105,280,996

 

Non-current liabilities

 

 

Lease liabilities

1,170,237

 

 

1,066,354

 

Other liabilities

37,733

 

 

35,019

 

Total non-current liabilities

1,207,970

 

 

1,101,373

 

Current liabilities

 

 

Trade and other payables

7,912,503

 

 

8,574,244

 

Liabilities from government grants received

2,145,135

 

 

8,300,000

 

Lease liabilities

370,153

 

 

366,171

 

Employee benefits

735,304

 

 

1,378,130

 

Other financial liabilities

130,338

 

 

138,206

 

Total current liabilities

11,293,433

 

 

18,756,751

 

Total Liabilities

12,501,404

 

 

19,858,124

 

TOTAL EQUITY AND LIABILITIES

114,633,041

 

 

125,139,120

 

 

 

 

InflaRx N.V. and subsidiaries

Unaudited Condensed Consolidated Statements of Changes in Shareholders’ Equity for the six months ended June 30, 2022 and 2021

(in €, except for share data)

Issued
capital

 

Share
premium

 

 

Other
capital
reserves

 

Accumulated
deficit

 

 

Other
components
of equity

 

 

Total
equity

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance as of January 1, 2022

5,304,452

 

280,310,744

 

 

30,591,209

 

(213,975,679

)

 

3,050,271

 

 

105,280,996

 

Loss for the period

 

 

 

 

(13,536,654

)

 

 

 

(13,536,654

)

Exchange differences on
translation of foreign currency

 

 

 

 

 

 

5,718,815

 

 

5,718,815

 

Total comprehensive loss

 

 

 

 

(13,536,654

)

 

5,718,815

 

 

(7,817,839

)

Equity-settled share-based payment

 

 

 

4,668,481

 

 

 

 

 

4,668,481

 

Balance as of June 30, 2022

5,304,452

 

280,310,744

 

 

35,259,689

 

(227,512,333

)

 

8,769,086

 

 

102,131,638

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance as of January 1, 2021

3,387,410

 

220,289,876

 

 

26,259,004

 

(168,345,620

)

 

(3,726,790

)

 

77,863,880

 

Loss for the period

 

 

 

 

(20,906,280

)

 

 

 

(20,906,280

)

Exchange differences
on translation of foreign currency

 

 

 

 

 

 

2,077,397

 

 

2,077,397

 

Total comprehensive loss

 

 

 

 

(20,906,280

)

 

2,077,397

 

 

(18,828,883

)

Issuance of common shares and warrants

1,873,203

 

63,269,346

 

 

 

 

 

 

 

65,142,549

 

Transaction costs

 

(4,219,222

)

 

 

 

 

 

 

(4,219,222

)

Equity-settled share-based payment

 

 

 

2,687,779

 

 

 

 

 

2,687,779

 

Share options exercised

41,741

 

921,994

 

 

 

 

 

 

 

963,735

 

Balance as of June 30, 2021

5,302,354

 

280,261,994

 

 

28,946,783

 

(189,251,900

)

 

1,649,393

 

 

123,609,838

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

InflaRx N.V. and subsidiaries

Unaudited Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2022 and 2021

in €

For the six
months ended
June 30, 2022

(unaudited)

 

For the six months
ended June 30,
2021

(unaudited)

 

 

 

Operating activities

 

 

Loss for the period

(13,536,654

)

 

(20,906,280

)

Adjustments for:

 

 

Depreciation & amortization of property and equipment, right-of-use assets and intangible assets

300,870

 

 

337,581

 

Net financial result

(2,408,345

)

 

(1,000,217

)

Share-based payment expense

4,668,481

 

 

2,687,779

 

Net foreign exchange differences

130,347

 

 

71,050

 

Changes in:

 

 

Financial assets from government grants

(8,260,503

)

 

 

Other assets

611,843

 

 

172,001

 

Employee benefits

(640,112

)

 

(662,388

)

Other liabilities

(7,867

)

 

7,020

 

Liabilities from government grants

(6,154,865

)

 

 

Trade and other payables

(661,741

)

 

672,727

 

Interest received

631,504

 

 

371,665

 

Interest paid

(32,039

)

 

(5,491

)

Net cash used in operating activities

(25,359,081

)

 

(18,254,553

)

Investing activities

 

 

Purchase of intangible assets, property and equipment

(9,728

)

 

(18,734

)

Purchase of current financial assets

(47,031,216

)

 

(27,535,842

)

Proceeds from the maturity of financial assets

59,595,044

 

 

29,497,122

 

Net cash from investing activities

12,554,101

 

 

1,942,546

 

Financing activities

 

 

Proceeds from issuance of common shares

 

 

65,142,549

 

Transaction costs from issuance of common shares

 

 

(4,219,222

)

Proceeds from exercise of share options

 

 

963,735

 

Repayment of lease liabilities

(182,014

)

 

(183,128

)

Net cash from (used in) financing activities

(182,014

)

 

61,703,934

 

Net decrease/increase in cash and cash equivalents

(12,986,995

)

 

45,391,927

 

Effect of exchange rate changes on cash and cash equivalents

2,153,152

 

 

999,820

 

Cash and cash equivalents at beginning of period

26,249,995

 

 

25,968,681

 

Cash and cash equivalents at end of period

15,416,152

 

 

72,360,428

 

 

 

 

About InflaRx N.V.:

InflaRx (Nasdaq: IFRX) is a clinical-stage biopharmaceutical company focused on applying its proprietary technology to discover and develop first-in-class or best-in-class, potent and specific inhibitors of C5a and C5aR. Complement C5a and its receptor C5aR are powerful inflammatory mediators involved in the progression of a wide variety of autoimmune and other inflammatory diseases. InflaRx was founded in 2007, and the group has offices and subsidiaries in Jena and Munich, Germany, as well as Ann Arbor, MI, USA. For further information, please visit www.inflarx.de.

The COVID-19 related work is partly funded by the German federal government through grant number 16LW0113 (VILO-COVID). All responsibility for the content of this work lies with InflaRx.

Contacts:

InflaRx N.V.

e-mail: IR@inflarx.de

MC Services AG

Katja Arnold, Laurie Doyle, Andreas Jungfer
e-mail: inflarx@mc-services.eu
Europe: +49 89-210 2280
US: +1-339-832-0752

FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “believe,” “estimate,” “predict,” “potential” or “continue” and similar expressions. Forward-looking statements appear in a number of places throughout this release and may include statements regarding InflaRx’s intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, the Company’s ongoing and planned pre-clinical development and clinical trials, including the development of vilobelimab to treat pyoderma gangrenosum (PG) and critical COVID-19; the Company’s submission of an application to the FDA in the third quarter of 2022 for emergency use authorization for vilobelimab to treat critically ill COVID-19 patients; the impact of the COVID-19 pandemic on the Company; the timing and its ability to commence and conduct clinical trials; potential results from current or potential future collaborations; its ability to make regulatory filings, obtain positive guidance from regulators, and obtain and maintain regulatory approvals for its product candidates; its intellectual property position; its ability to develop commercial functions; expectations regarding clinical trial data; decisions regarding the strategic direction of the Company; its results of operations, cash needs, financial condition, liquidity, prospects, future transactions, growth and strategies; the industry in which the Company operates; the trends that may affect the industry or the Company; its status as foreign private issuer; and the risks, uncertainties and other factors described under the heading “Risk Factors” in InflaRx’s periodic filings with the SEC. These statements speak only as of the date of this press release and involve known and unknown risks, uncertainties and other important factors that may cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and InflaRx assumes no obligation to update these forward-looking statements, even if new information becomes available in the future, except as required by law.


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