0001140361-22-010862.txt : 20220324 0001140361-22-010862.hdr.sgml : 20220324 20220324084010 ACCESSION NUMBER: 0001140361-22-010862 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20220324 FILED AS OF DATE: 20220324 DATE AS OF CHANGE: 20220324 FILER: COMPANY DATA: COMPANY CONFORMED NAME: InflaRx N.V. CENTRAL INDEX KEY: 0001708688 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: P7 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-38283 FILM NUMBER: 22764792 BUSINESS ADDRESS: STREET 1: WINZERLAER STR. 2 CITY: JENA STATE: 2M ZIP: 07745 BUSINESS PHONE: 49 3641 508180 MAIL ADDRESS: STREET 1: WINZERLAER STR. 2 CITY: JENA STATE: 2M ZIP: 07745 FORMER COMPANY: FORMER CONFORMED NAME: Fireman B.V. DATE OF NAME CHANGE: 20170606 6-K 1 brhc10035588_6k.htm 6-K
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549



FORM 6-K



REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13A-16 OR 15D-16 UNDER
THE SECURITIES EXCHANGE ACT OF 1934

For the month of March 2022

Commission File Number: 001-38283



InflaRx N.V.

(Translation of registrant's name into English)



Winzerlaer Str. 2
07745 Jena, Germany
(Address of principal executive office)

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F  ☒         Form 40-F ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐



INFLARX N.V.

On March 24, 2022, InflaRx N.V. issued a press release. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated by reference herein.


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 
INFLARX N.V.
   
Date: March 24, 2022
By:
/s/ Niels Riedemann
 
Name:
Niels Riedemann
 
Title:
Chief Executive Officer

3

EXHIBIT INDEX

Exhibit No.
 
Description
 
Press Release, dated March 24, 2022
 

4

EX-99.1 2 brhc10035588_ex99-1.htm EXHIBIT 99.1
Exhibit 99.1

 

InflaRx Reports Full Year 2021 Financial and Operating Results

Company received corrected FDA advice letter for Phase III trial with vilobelimab in hidradenitis suppurativa
Positive Phase IIa data reported with vilobelimab in pyoderma gangrenosum; data being presented as late-breaker oral presentation at AAD Annual Meeting
Topline data in vilobelimab Phase III trial in severe COVID-19 expected by end of March
Both US and EU Phase II trials with vilobelimab in AAV met their objectives
Phase II trial with vilobelimab in cSCC enrolling with first efficacy data expected later this year
New program, INF904 oral small molecule inhibitor of C5aR, recently introduced
Year-end cash and cash equivalents of approximately €26.2 million and financial assets of approximately €84.4 million
 
Jena, Germany, March 24, 2022 – 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 year ended December 31, 2021.
 
Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx, commented: “We have made important progress in broadening and advancing our development activities over the course of 2021 and into 2022. This includes introducing a new program, the oral small molecule C5aR inhibitor, INF904, and moving vilobelimab into a new indication, cutaneous small cell carcinoma.  In addition, we reported promising results with vilobelimab in pyoderma gangrenosum and ANCA-associated vasculitis, and we now await the Phase III topline results in our COVID-19 trial. We are hopeful for a positive outcome but, either way, we believe the results will help to further the overall understanding of this devastating disease.”
 
He continued, “We are thankful for the corrected advice letter from the FDA related to vilobelimab development in hidradenitis suppurativa and will clarify our path forward in this debilitating disease in the coming months. We expect a busy year ahead as we work towards our goal of developing treatments to control inflammation and improve the lives of patients suffering from neutrophil-driven diseases.”


 
Recent Highlights and R&D Update
 
Vilobelimab for Hidradenitis Suppurativa (HS)
 
In February 2022, the Company received an advice letter from the FDA related to its Phase III program and its IND. The feedback to the clinical protocol indicated that the FDA recommends using the Hidradenitis Suppurativa Clinical Response Score (“HiSCR”) as the primary endpoint in the Phase III trial. This FDA advice contrasted with the FDA advice provided to the Company in a Type A meeting held in the third quarter of 2021.

In the minutes from that Type A meeting, FDA provided advice on how to implement, name and validate the meaningfulness of the modified HiSCR, a new primary endpoint suggested by the Company, which would measure the reduction of all three types of inflammatory lesions in HS–inflammatory nodules, abscesses and draining tunnels. A reduction in draining tunnels is not captured by the HiSCR. In these minutes, the FDA did not recommend the traditional HiSCR as the primary endpoint measure. Based on the advice received in the Type A meeting, InflaRx announced in January 2022, the initiation of a Phase III program designed to study patients with moderate to severe HS suffering from actively draining tunnels. Because of the letter, InflaRx paused activities related to the Phase III trial.

In March 2022, the Company received a corrected advice letter from the FDA. The corrected letter states that the FDA advice received by the Company in February 2022 “contains errors.” In this corrected letter, the FDA no longer recommends that the Company use the HiSCR as the primary endpoint for the chosen patient population but gives recommendations related to implementation of the modified HiSCR.

In light of this corrected advice from FDA, InflaRx believes that further development in HS is feasible. InflaRx is now evaluating next steps for the program, as the Phase III trial activities remain on hold while InflaRx evalutes next steps for the program.

Vilobelimab in Pyoderma Gangrenosum (PG)

InflaRx previously initiated an open label, multi-center Phase IIa exploratory study enrolling patients with moderate to severe PG in Canada, the United States and Poland. The study evaluated the safety and efficacy of vilobelimab in patients with PG.
 

 
In October 2021, InflaRx announced preliminary results from the third dosing cohort. At 2400mg biweekly, six of the seven patients achieved clinical remission with a PGA score of ≤1, which reflects a closure of the target ulcer. All patients in the third dosing cohort had elevated C5a levels at baseline that were continuously suppressed after initiation of vilobelimab.
 
In August 2021, InflaRx also reported data for ten evaluable patients in the first two dose cohorts at day 99. The patient in the second dosing cohort demonstrating complete target ulcer closure had been increased from the 1600mg dose group to the highest dose of 2400mg dose on day 57 of the study, and the ulcer closed after the dose escalation.
 
Final data will be presented as a late-breaker oral presentation on March 26th at the American Academy of Dermatology Association (AAD) Annual Meeting.
 
InflaRx plans to meet with the FDA this year to discuss the design for a pivotal study.
 
Vilobelimab for Severe COVID-19

In October 2021, InflaRx announced full enrollment in the Phase III part of the global Phase II/III trial evaluating vilobelimab in mechanically ventilated patients with COVID-19. A total of 369 patients across several countries, including in Europe, South America and other regions, were enrolled. Topline data for the 28-day mortality primary endpoint is expected to be available by the end of March 2022. The results from this Phase III trial will heavily influence our decision with respect to any future development of vilobelimab in COVID-19 and the larger strategic focus of the Company.

In October 2021, InflaRx announced that it had received a grant of up to €43.7 million from the German Ministry of Education and Research and the German Ministry of Health to support the Company’s development of vilobelimab for the treatment of severe COVID-19 patients. The initial tranche amounts to €25.8 million (approximately $29.9 million) and is structured as reimbursement of 80% of certain pre-specified expenses related to the clinical development and manufacturing of vilobelimab. The remainder of the grant will be awarded in three additional subsequent tranches, each conditional on reaching agreed-upon development and manufacturing-related milestones for the preceding tranche and structured as reimbursement for Company expenses. Individual tranches will not be paid if the preceding milestone of a tranche is not met. As of December 31, 2021, InflaRx had received €8.3 million of this grant funding.


 
Vilobelimab for ANCA-associated Vasculitis (AAV)

In May 2021, InflaRx reported topline data from the U.S. IXPLORE Phase II study of vilobelimab in AAV. The results indicated that vilobelimab, when added to the current standard of care, was well tolerated.

In November 2021, InflaRx reported topline data from the European Phase II IXCHANGE study of vilobelimab in AAV. The study achieved its principal objective, demonstrating comparable clinical response of vilobelimab to standard of care, while significantly reducing the need for glucocorticoid treatment in this life-threatening indication.

The Company plans to discuss the data from the U.S. and EU studies with regulatory authorities to determine next steps with this program.

Vilobelimab for Cutaneous Squamous Cell Carcinoma (cSCC)

InflaRx is developing vilobelimab for the treatment of PD-1/PD-L1 inhibitor resistant/refractory locally advanced or metastatic cSCC. InflaRx previously initiated an open label, non-comparative, two-stage, Phase II trial (NCT04812535) at sites in Europe, the United States and elsewhere. The study is investigating two independent arms: vilobelimab alone (Arm A) and vilobelimab in combination with pembrolizumab (Arm B). The trial is expected to enroll a total of approximately 70 patients.

In February 2022, the Company announced the start of the second dosing cohort of Arm B. The interim analysis in this arm, which is required to move to the second stage of the Phase II trial, is expected after ten patients have been treated and are evaluable for response assessment at the recommended Phase II dose level, which will be selected based on data from the safety run-in phase of the study. These data are expected to be available in the first quarter of 2023.

In parallel, enrollment continues in the monotherapy Arm A. Six patients are now enrolled in this arm. The interim analysis in Arm A required to proceed to the second stage is expected to be available after ten patients are evaluable for response assessment. These data are expected to be available in the third quarter of 2022.


 
INF904

InflaRx announced in January 2022 a new pipeline program, INF904, an oral small molecule inhibitor of C5aR. InflaRx has been granted a composition of matter patent for INF904 and associated compounds by the U.S. Patent and Trademark Office and has completed IND-enabling (preclinical) studies that demonstrated no obvious toxicological findings even in the highest dose groups in required GLP toxicity analyses.

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.

2021 Financial Highlights
 
Research and Development Expenses
 
InflaRx’s research and development expenses increased by €10.0 million in the year ended December 31, 2021 compared to the year ended December 31, 2020.
 
This increase is attributable to higher contract research organization (CRO) and contract manufacturing organization (CMO) costs from clinical trials in the amount of €8.4 million. This increase was primarily due to higher expense for the Phase III part of our COVID-19 trial and other running trials like Phase II clinical program in patients with AAV, the Phase II clinical program in patients with PG, the preparation of a Phase II clinical program in patients cSCC and ongoing manufacturing activities for clinical trial related materials.
 
In addition, a €1.5 million increase in employee-related costs was mainly caused by a €1.0 million increase in expenses from share-based compensation.
 
General and Administrative Expenses
 
InflaRx’s general and administrative expenses increased by €3.5 million to €12.0 million for the year ended December 31, 2021, from €8.5 million for the year ended December 31, 2020. This increase is primarily attributable to a €2.2 million increase in expenses from share-based compensation. Legal, consulting and audit fees and other expenses increased by €0.5 million to €2.1 million for the year ended December 31, 2021, mainly due to higher consulting and legal costs, mainly triggered by SOX implementation. The increase of other expenses by €0.4 million is primarily related to higher D&O insurance cost.


 
Net Financial Result
 
InflaRx’s net financial result increased by €2.0 million in the year ended December 31, 2021 compared to the year ended December 31, 2020. This net increase is mainly attributable to higher foreign exchange income, which increased by €1.9 million and lower foreign exchange expense, which decreased by €0.8 million. This effect was offset by lower interest income on marketable securities, which decreased by €0.8 million.
 
Net Loss
 
InflaRx incurred a net loss of €45.6 million, or €1.10 per common share, in the year ended December 31, 2021 compared to €34.0 million, or €1.3 per common share, in the year ended December 31, 2020. As of December 31, 2021, the Company’s total funds available were approximately €110.6 million, composed of €26.2 million of cash and cash equivalents and €84.4 million of financial assets.
 
Net Cash Used in Operating Activities
 
InflaRx’s net cash used in operating activities increased to €39.9 million in the year ended December 31, 2021, from €36.5 million in the year ended December 31, 2020, mainly due to the increase of research and development expenditures and higher personnel costs.
 
Additional information regarding these results and other relevant information is included in the notes to the financial statements as of December 31, 2021 in “Item 18. Financial Statements,” which are included in InflaRx’s  most recent annual report on Form 20-F as filed with the U.S. Securities and Exchange Commission.
 

 
InflaRx N.V. and subsidiaries
Consolidated Statements of Operations and Comprehensive Loss for the Years Ended December 31, 2021, 2020 and 2019
 
in €, except for share information
 
2021
   
2020
   
2019
 
                   
Operating Expenses
                 
Research and development expenses
   
(35,697,935
)
   
(25,684,140
)
   
(44,582,136
)
General and administrative expenses
   
(11,984,722
)
   
(8,467,203
)
   
(12,501,048
)
Total Operating Expenses
   
(47,682,657
)
   
(34,151,343
)
   
(57,083,184
)
Other income
   
54,221
     
221,748
     
400,253
 
Other expenses
   
(6,381
)
   
(13,209
)
   
(85,242
)
Operating Result
   
(47,634,816
)
   
(33,942,804
)
   
(56,768,173
)
Finance income
   
109,391
     
887,702
     
2,840,676
 
Finance expenses
   
(24,769
)
   
(26,000
)
   
(22,265
)
Foreign exchange result
   
1,964,135
     
(776,512
)
   
694,944
 
Other financial result
   
(44,000
)
   
(126,000
)
   
 
Income Taxes
   
     
     
 
Loss for the Period
   
(45,630,059
)
   
(33,983,614
)
   
(53,254,817
)
                         
Share Information
                       
Weighted average number of shares outstanding
   
41,629,974
     
27,064,902
     
26,004,519
 
Loss per share (basic/diluted)
   
(1.10
)
   
(1.26
)
   
(2.05
)
                         
Loss for the Period
   
(45,630,059
)
   
(33,983,614
)
   
(53,254,817
)
Other comprehensive income (loss) that may be re-clas-si-fied to profit or loss in subsequent periods:
                       
Exchange differences on translation of foreign currency
   
6,777,061
     
(5,954,019
)
   
2,177,033
 
Total Comprehensive Loss
   
(38,852,998
)
   
(39,937,633
)
   
(51,077,785
)


 
InflaRx N.V. and subsidiaries
Consolidated Statements of Financial Position as December 31, 2021 and 2020
 
in €
 
2021
   
2020
 
             
ASSETS
           
Non-current assets
           
Property and equipment*
   
274,373
     
408,263
 
Right-of-use assets*
   
1,408,078
     
546,694
 
Intangible assets
   
235,216
     
350,183
 
Other assets
   
336,566
     
353,522
 
Financial assets
   
27,206,990
     
272,268
 
Total non-current assets
   
29,461,224
     
1,930,930
 
Current assets
               
Current other assets*
   
10,983,458
     
3,734,700
 
Income tax receivable*
   
1,282,177
     
1,419,490
 
Financial assets
   
57,162,266
     
55,162,033
 
Cash and cash equivalents
   
26,249,995
     
25,968,681
 
Total current assets
   
95,677,896
     
86,284,904
 
TOTAL ASSETS
   
125,139,120
     
88,215,834
 
                 
EQUITY AND LIABILITIES
               
Equity
               
Issued capital
   
5,304,452
     
3,387,410
 
Share premium
   
280,310,744
     
220,289,876
 
Other capital reserves
   
30,591,209
     
26,259,004
 
Accumulated deficit
   
(213,975,679
)
   
(168,345,620
)
Other components of equity
   
3,050,270
     
(3,726,791
)
Total equity
   
105,280,996
     
77,863,880
 
Non-current liabilities
               
Lease liabilities
   
1,066,354
     
220,525
 
Other liabilities
   
35,019
     
33,323
 
Total non-current liabilities
   
1,101,373
     
253,847
 
Current liabilities
               
Trade and other payables
   
8,574,244
     
8,258,133
 
Liabilities from government grants received
   
8,300,000
     
 
Lease liabilities
   
366,171
     
338,516
 
Employee benefits
   
1,378,130
     
1,368,731
 
Other liabilities
   
138,206
     
117,727
 
Provisions
   
     
15,000
 
Total current liabilities
   
18,756,751
     
10,098,107
 
Total Liabilities
   
19,858,124
     
10,351,954
 
TOTAL EQUITY AND LIABILITIES
   
125,139,120
     
88,215,834
 


 
InflaRx N.V. and subsidiaries
Consolidated Statements of Changes in Shareholders’ Equity for the Years Ended December 31, 2021, 2020 and 2019
 
in €
 
Issued
capital
   
Share
premium
   
Other
capital reserves
   
Accumulated deficit
   
Other
components of equity
   
Total
equity
 
                                     
Balance as of January 1, 2019
   
3,115,725
     
211,021,835
     
18,310,003
     
(81,107,188
)
   
50,196
     
151,390,571
 
Loss for the Period
   
     
     
     
(53,254,817
)
   
     
(53,254,817
)
Exchange differences on
translation of foreign currency
   
     
     
     
     
2,177,033
     
2,177,033
 
Total Comprehensive Loss
   
     
     
     
(53,254,817
)
   
2,177,033
     
(51,077,784
)
Equity-settled share-based pay-ments
   
     
     
6,832,210
     
     
     
6,832,210
 
Share options exercised
   
16,905
     
(15,229
)
   
     
     
     
1,676
 
Balance as of December 31, 2019
   
3,132,631
     
211,006,606
     
25,142,213
     
(134,362,006
)
   
2,227,228
     
107,146,673
 
Loss for the Period
   
     
     
     
(33,983,614
)
   
     
(33,983,614
)
Exchange differences on
translation of foreign currency
   
     
     
     
     
(5,954,019
)
   
(5,954,019
)
Total Comprehensive Loss
   
     
     
     
(33,983,614
)
   
(5,954,019
)
   
(39,937,633
)
Issuance of common shares
   
234,982
     
9,535,961
     
     
     
     
9,770,943
 
Transaction costs
   
     
(729,840
)
   
     
     
     
(729,840
)
Equity-settled share-based pay-ments
   
     
     
1,116,791
     
     
     
1,116,791
 
Share options exercised
   
19,797
     
477,149
     
     
     
     
496,946
 
Balance as of December 31, 2020
   
3,387,410
     
220,289,876
     
26,259,004
     
(168,345,620
)
   
(3,726,791
)
   
77,863,880
 
Loss for the Period
   
     
     
     
(45,630,059
)
   
     
(45,630,059
)
Exchange differences on
translation of foreign currency
   
     
     
     
     
6,777,061
     
6,777,061
 
Total Comprehensive Loss
   
     
     
     
(45,630,059
)
   
6,777,061
     
(38,852,998
)
Issuance of common shares
   
1,873,203
     
63,269,346
     
     
     
     
65,142,549
 
Transaction costs
   
     
(4,219,222
)
   
     
     
     
(4,219,222
)
Equity-settled share-based pay-ments
   
     
     
4,332,205
     
     
     
4,332,205
 
Share options exercised
   
43,839
     
970,744
     
     
     
     
1,014,583
 
Balance as of December 31, 2021
   
5,304,452
     
280,310,744
     
30,591,209
     
(213,975,679
)
   
3,050,270
     
105,280,996
 


 
InflaRx N.V. and subsidiaries
Consolidated Statements of Cash Flows for the Years ended December 31, 2021, 2020 and 2019
 
in €
 
2021
   
2020
   
2019
 
                   
Operating activities
                 
Loss for the Period
   
(45,630,059
)
   
(33,983,614
)
   
(53,254,817
)
Adjustments for:
                       
Depreciation & amortization of property and equipment, right-of-use assets and intangible assets
   
669,434
     
712,713
     
663,166
 
Net finance income
   
(2,004,757
)
   
40,810
     
(3,513,355
)
Share-based payment expense
   
4,332,205
     
1,116,791
     
6,832,210
 
Net foreign exchange differences
   
111,606
     
(247,322
)
   
(368,477
)
Other non-cash adjustments
   
     
3,436
     
60,628
 
Changes in:
                       
Other assets
   
(7,094,467
)
   
(1,554,611
)
   
(2,364,399
)
Employee benefits
   
(3,290
)
   
355,545
     
235,500
 
Other liabilities
   
19,863
     
8,960
     
(209,948
)
Liabilities from government grants received
   
8,300,000
     
     
 
Trade and other payables
   
316,112
     
(4,155,529
)
   
5,734,795
 
Interest received
   
1,070,235
     
1,201,547
     
3,001,109
 
Interest paid
   
(23,633
)
   
(26,387
)
   
(20,903
)
Net cash used in operating activities
   
(39,936,750
)
   
(36,527,661
)
   
(43,204,492
)
Investing activities
                       
Purchase of intangible assets and property and equipment
   
(37,778
)
   
(94,189
)
   
(594,889
)
Purchase of non-current other financial assets
   
     
     
(75,543
)
Purchase of current  and non current financial assets
   
(97,516,417
)
   
(101,600,176
)
   
(82,547,409
)
Proceeds from the maturity of current financial assets
   
71,603,310
     
123,056,347
     
103,559,395
 
Net cash from/ (used in) investing activities
   
(25,950,885
)
   
21,361,982
     
20,341,554
 
Financing activities
                       
Proceeds from issuance of common shares
   
65,142,549
     
9,770,944
     
 
Transaction costs from issuance of common shares
   
(4,219,222
)
   
(729,841
)
   
 
Proceeds from exercise of share options
   
1,014,583
     
496,946
     
1,676
 
Repayment of lease liabilities
   
(360,644
)
   
(366,156
)
   
(296,020
)
Net cash from/ (used in) financing activities
   
61,577,266
     
9,171,893
     
(294,344
)
Net increase/(decrease) in cash and cash equivalents
   
(4,310,369
)
   
(5,993,786
)
   
(23,157,282
)
Effect of exchange rate changes on cash and cash equivalents
   
4,591,683
     
(1,168,813
)
   
902,321
 
Cash and cash equivalents at beginning of period
   
25,968,681
     
33,131,280
     
55,386,240
 
Cash and cash equivalents at end of period
   
26,249,995
     
25,968,681
     
33,131,280
 


 
About Vilobelimab (IFX-1):
 
Vilobelimab is a first-in-class monoclonal anti-human complement factor C5a antibody, which highly and effectively blocks the biological activity of C5a and demonstrates high selectivity towards its target in human blood. Thus, vilobelimab leaves the formation of the membrane attack complex (C5b-9) intact as an important defense mechanism, which is not the case for molecules blocking the cleavage of C5. Vilobelimab has been demonstrated to control the inflammatory response driven tissue and organ damage by specifically blocking C5a as a key “amplifier” of this response in pre-clinical studies. Vilobelimab is believed to be the first monoclonal anti-C5a antibody introduced into clinical development. Over 300 people have been treated with vilobelimab in clinical trials, and the antibody has been shown to be well tolerated. Vilobelimab is being developed for various indications, including hidradenitis suppurativa, ANCA-associated vasculitis and pyoderma gangrenosum, as well as severe COVID-19 and cutaneous squamous cell carcinoma (cSCC).
 
About InflaRx N.V.:
 
InflaRx (Nasdaq: IFRX) is a clinical-stage biopharmaceutical company focused on applying its proprietary anti-C5a technology to discover and develop first-in-class, potent and specific inhibitors of C5a. Complement C5a is a powerful inflammatory mediator 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.
 
Contacts:
 
InflaRx N.V.
 
Jordan Zwick – Chief Strategy Officer
Email: IR@inflarx.de
Tel: +1 917-338-6523
 
MC Services AG
 
Katja Arnold, Laurie Doyle, Andreas Jungfer
Email: 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 our intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, our ongoing and planned pre-clinical development and clinical trials, in particular our Phase III trial in HS and related communications with the FDA, in particular addressing the FDA’s advice in various communications to us regarding the primary endpoint for the Phase III trial; the impact of the COVID-19 pandemic on the Company; the timing and our ability to commence and conduct clinical trials; potential results from current or potential future collaborations; our ability to make regulatory filings, obtain positive guidance from regulators, and obtain and maintain regulatory approvals for our product candidates; our intellectual property position; our ability to develop commercial functions; expectations regarding clinical trial data; our results of operations, cash needs, financial condition, liquidity, prospects, future transactions, growth and strategies; the industry in which we operate; the trends that may affect the industry or us and the risks, uncertainties and other factors described under the heading “Risk Factors” in InflaRx’s most recent annual report on Form 20-F filed with the Securities and Exchange Commission.
 
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 our 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 we assume 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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