InflaRx Reports Second Quarter 2021 Financial & Operating Results

Thursday, 05. August 2021 13:30
  • Severe COVID-19 trial enrollment reaches 299 patients; an independent data monitoring committee has recommended to continue the trial as planned after analyzing data from the first 180 evaluable patients

  • Type A meeting request submitted to further discuss primary endpoint for the Phase III clinical development of vilobelimab in Hidradenitis Suppurativa

  • First three patients dosed with vilobelimab in Phase II Cutaneous Squamous Cell Carcinoma trial

  • Dr. Korinna Pilz promoted to Chief Clinical Development Officer

  • Cash, cash equivalents and financial assets of approximately €127.5 million as of June 30, 2021

JENA, Germany, Aug. 05, 2021 (GLOBE NEWSWIRE) -- InflaRx (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, 2021.

“I am very pleased to announce the promotion of Dr. Korinna Pilz to Chief Clinical Development Officer. Korinna has an impressive background with more than 20 years of drug development experience in biotech and large pharma. Korinna has been instrumental in leading the development of our pipeline programs and building the internal clinical team over the past few years. Our team has been impressed by her professional excellence and we are wishing Korinna a great start in her new role,” said Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx. “Our team has continued to work hard to advance the clinical development of vilobelimab in several indications, including the initiation of our first clinical trial for treating cancer patients. We are pleased that the independent data monitoring committee has recommended that the COVID-19 trial shall continue as planned. Earlier clinical results with vilobelimab in this challenging disease showed promise and suggested that C5a inhibition might be beneficial in critically ill COVID-19 patients. We look forward to the results of the Phase III trial, which is on track to read out by the end of this year. We also expect data readouts from our clinical trials in ANCA-associated Vasculitis and Pyoderma Gangraenosum by year end. With upcoming data from these trials as well as plans to meet with the FDA to discuss next steps in Hidradenitis Suppurativa, it promises to be a busy second half of 2021.”

Recent Corporate Highlights and R&D Update

Dr. Korinna Pilz promoted to Chief Clinical Development Officer
Dr. Pilz has been promoted effective August 1st, 2021, to the newly created role of Chief Clinical Development Officer. She joined InflaRx in January 2019 as Program Director Oncology and was promoted to Global Head of Clinical Research and Development in November 2019. She has 20 years’ experience in NCE and NBE development in several companies, including Boehringer Ingelheim, Roche, Merck KGaA and Bayer, and as a consultant. She has vast experience in early and late-stage clinical development and has helped in gaining marketing authorizations for several products. At InflaRx, she has established and grown the clinical development group and under her leadership the group has initiated several clinical trials, including for vilobelimab in cSCC and COVID-19. Korinna is a licensed Medical Doctor and holds a Diploma in Biology from the University of Düsseldorf. She is a member of ASCO, ESMO, AACR and IASLC.

Vilobelimab for Hidradenitis Suppurativa (HS)
InflaRx has submitted a Type A meeting request to the U.S. Food and Drug Administration (FDA) for the HS program to discuss the primary endpoint in the Phase III program. InflaRx expects to hold this Type A meeting by the end of Q3.

As previously reported in 2020, InflaRx received scientific advice from the European Medicines Agency (EMA) about the European pathway for regulatory approval, including supporting the use of the International Hidradenitis Suppurativa Severity Score System (IHS4) as the primary endpoint.

Once InflaRx receives final feedback from the FDA on the proposed Phase III primary endpoint, the Company will determine the best path forward for the global development program in HS.

Vilobelimab for Severe COVID-19
The Phase III part of the global Phase II/III trial evaluating vilobelimab in mechanically ventilated patients with COVID-19 was initiated in mid-September 2020, and recruitment has reached 299 patients, with 49 sites initiated across several countries, including the United States, Russia, South Africa and countries in Europe and Latin America. An interim analysis by an independent data monitoring committee (IDMC), which took place in July and analyzed the data of the first 180 patients evaluable for 28-day mortality, led to a recommendation to continue the study as planned. Per recommendations from EMA and FDA, the option to potentially stop the study early on the basis of efficacy was removed from the interim analysis. Additional trial sites are expected to be added, including in the United States. Topline data for all 360 enrolled patients at the 28-day mortality primary endpoint are expected to be available by the end of 2021.

Vilobelimab for ANCA-associated Vasculitis (AAV)
In the US IXPLORE clinical Phase II study of IFX-1 in AAV, all patients have completed treatment. In May 2021, InflaRx reported topline data for the study, which indicated that vilobelimab, when given in addition to best standard of care, was shown to be well tolerated. Furthermore, InflaRx previously reported that both Part 1 and Part 2 of the AAV Phase II study in Europe (IXCHANGE) are fully enrolled. Data from this randomized, double-blind, placebo-controlled trial with 57 patients are expected by the end of 2021.

Vilobelimab in Cutaneous Squamous Cell Carcinoma (cSCC)
The Company recently announced that the first patient had been dosed in the open label, multicenter Phase II study evaluating vilobelimab alone and in combination with pembrolizumab in patients with PD-1 or PD-L1 inhibitor resistant/refractory locally advanced or metastatic cSCC.

The study will investigate two independent arms: vilobelimab alone and vilobelimab in combination with pembrolizumab. The main objectives of the trial are to assess antitumor activity and safety of vilobelimab monotherapy and to determine the maximum tolerated or recommended dose, safety and antitumor activity in the combination arm.

So far, a total of three patients have been enrolled in the monotherapy arm. A safety assessment after at least five weeks of treatment will determine continuation of enrollment in the monotherapy and opening of the combination arm.

Vilobelimab in Pyoderma Gangraenosum
As previously announced, the Phase IIa open label trial has reached the target enrollment goal of 18 patients with moderate to severe PG at sites in the U.S., Canada and Europe. Promising initial data from the first five patients in the study were announced in 2020. A second interim analysis, including six patients treated at the second dose group until day 99, are expected to be available by the end of Q3 2021. Final results from all patients, including the highest dose group, are expected in the first half of 2022.

Financial highlights – Q2 2021

Research and development expenses incurred for the six months ended June 30, 2021 increased over the corresponding period in 2020 by €1.6 million to €16.2 million for the six months ended June 30, 2021. This increase was primarily due to the higher expense for the phase III part of our COVID-19 trial and was driven by an overall increase in third-party expenses of €1.0 million. The €0.7 million increase in personnel expenses was mainly related to equity-settled share-based compensation.

General and administrative expenses increased by €0.8 million to €5.7 million for the six months ended June 30, 2021, from €4.9 million for the six months ended June 30, 2020. This increase is attributable to higher expenses from equity-settled share-based compensation recognized in personnel expenses. Furthermore, legal, consulting and other expenses increased by €0.1 million to €2.2 million for the six months ended June 30, 2021, from €2.1 million for the six months ended June 30, 2020.

Net financial result decreased by €0.1 million to €1.0 million for the six months ended June 30, 2021, from €1.1 million for the six months ended June 30, 2020. This decrease is mainly attributable to higher foreign exchange gains, which increased by €2.6 million and higher foreign exchange losses of €2.2 million while interest on marketable securities declined by €0.7 million. Other finance expenses for the six months ended June 30, 2021 include a €43 thousand gain from a reduction in the allowance for expected credit loss on marketable securities.

Net loss for the six months ended June 30, 2021 was €20.9 million, compared to €18.3 million for the six month ended June 30, 2020.

On June 30, 2021, the Company’s total funds available were approximately €127.5 million, composed of cash and cash equivalents (€72.4 million), current and non-current financial assets and other non-current assets (€55.1 million).

Net cash used in operating activities for the six months ended June 30, increased to €18.3 million in the six months ended June 30, 2021, from €18.2 million in the six months ended June 30, 2020.

Additional information regarding these results and other relevant information is included in the notes to the unaudited Condensed Consolidated Financial Statements as of June 30, 2021, as well as the financial statements as of December 31, 2020 in “ITEM 18. Financial statements,” which is included in InflaRx’s Annual Report on Form 20-F 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, 2021 and 2020

 For the three months ended
June 30,
For the six months ended
June 30,
(in €, except for share data)2021
(unaudited)
 2020
(unaudited)
 2021
(unaudited)
 2020
(unaudited)
     
Operating Expenses    
Research and development expenses(11,299,270) (7,356,326) (16,206,155) (14,655,125)
General and administrative expenses(2,697,839) (2,326,895) (5,720,177) (4,891,698)
Total Operating Expenses(13,997,109) (9,683,221) (21,926,332) (19,546,822)
Other income15,216  102,332  20,678  197,292 
Other expenses(279) (3,450) (844) (9,170)
Operating Result(13,982,172) (9,584,339) (21,906,498) (19,358,701)
Finance income35,622  348,321  58,584  749,756 
Finance expenses(3,050) (3,111) (6,734) (5,258)
Foreign exchange result(826,303) (593,703) 905,367  547,974 
Other financial result(5,000) (200,000) 43,000  (200,000)
Income Taxes       
Loss for the Period(14,780,903) (10,032,832) (20,906,280) (18,266,229)
            
Share Information    
Weighted average number of shares outstanding44,186,279  26,172,023  39,024,533  26,138,639 
Loss per share (basic/diluted)(0.33) (0.38) (0.54) (0.70)
            
Loss for the Period(14,780,903) (10,032,832) (20,906,280) (18,266,229)
Other comprehensive income that may be reclassified to profit or loss in subsequent periods:           
Exchange differences on translation of foreign currency(1,427,302) (1,452,973) 2,077,397  260,895 
Total Comprehensive Loss(16,208,205) (11,485,805) (18,828,883) (18,005,334)
     

InflaRx N.V. and subsidiaries
Unaudited Condensed Consolidated Statements of Financial Position
as of June 30, 2021 and December 31, 2020

in €June 30,2021
(unaudited)
 December 31,
2020
     
ASSETS  
Non-current assets  
Property and equipment334,556  408,263 
Right-of-use assets1,592,801  546,694 
Intangible assets291,969  350,183 
Other assets342,899  353,522 
Financial assets272,390  272,268 
Total non-current assets2,834,615  1,930,930 
Current assets  
Current other assets4,140,348  3,734,700 
Current tax assets852,464  1,419,490 
Financial assets54,837,260  55,162,033 
Cash and cash equivalents72,360,428  25,968,681 
Total current assets132,190,500  86,284,904 
TOTAL ASSETS135,025,116  88,215,834 
   
EQUITY AND LIABILITIES  
Equity  
Issued capital5,302,354  3,387,410 
Share premium280,261,994  220,289,876 
Other capital reserves28,946,783  26,259,004 
Accumulated deficit(189,251,900) (168,345,620)
Other components of equity(1,649,393) (3,726,791)
Total equity123,609,838  77,863,880 
Non-current liabilities     
Lease liabilities1,244,785  220,525 
Other liabilities33,990  33,323 
Total non-current liabilities1,278,775  253,847 
Current liabilities  
Trade and other payables8,930,859  8,258,133 
Lease liabilities360,221  338,516 
Employee benefits720,441  1,368,731 
Other financial liabilities124,982  117,727 
Provisions  15,000 
Total current liabilities10,136,503  10,098,107 
Total Liabilities11,415,278  10,351,954 
TOTAL EQUITY AND LIABILITIES135,025,116  88,215,834 
      

InflaRx N.V. and subsidiaries
Unaudited Condensed Consolidated Statements of Changes in Shareholders’
Equity for the six months ended June 30, 2021 and 2020

(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, 20213,387,410  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)
Issue of ordinary shares1,873,203  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 exercised41,741  921,994        963,735 
Balance as of June 30, 20215,302,354  280,261,994  28,946,783  (189,251,900) (1,649,393) 123,609,838 
           
Balance as of January 1, 20203,132,631  211,006,606  25,142,213  (134,362,006) 2,227,228  107,146,673 
Loss for the period      (18,266,229)   (18,266,229)
Exchange differences
on translation of foreign currency
        260,895  260,895 
Total comprehensive loss      (18,266,229) 260,895  (18,005,334)
Equity-settled share-based payment    1,484,972      1,484,972 
Share options exercised19,797  477,149        496,946 
Balance as of June 30, 20203,152,427  211,483,756  26,627,185  (152,628,234) 2,488,124  91,123,258 
                  

InflaRx N.V. and subsidiaries
Unaudited Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2021 and 2020

in €For the six
months ended
June 30, 2021
(unaudited)
 For the six
months ended
June 30, 2020
(unaudited)
   
Operating activities  
Loss for the period(20,906,280) (18,266,229)
Adjustments for:  
Depreciation & amortization of property and equipment, right-of-use assets and intangible assets337,581  353,976 
Net financial result(1,000,217) (1,092,472)
Share-based payment expense2,687,779  1,484,972 
Net foreign exchange differences71,050  (789,528)
Other non-cash adjustments   
Changes in:  
Other assets172,001  560,449 
Employee benefits(662,388) (122,411)
Other liabilities7,020  341,012 
Trade and other payables672,727  (1,783,200)
Interest received371,665  1,096,651 
Interest paid(5,491) (5,455)
Net cash used in operating activities(18,254,553) (18,222,235)
Investing activities  
Purchase of intangible assets, property and equipment(18,734) (35,107)
Purchase of current financial assets(27,535,842) (59,196,096)
Proceeds from the maturity of financial assets29,497,122  79,504,059 
Net cash from investing activities1,942,546  20,272,857 
Financing activities  
Proceeds from issuance of common shares65,142,549   
Transaction costs from issuance of common shares(4,219,222)  
Proceeds from exercise of share options963,735  496,946 
Repayment of lease liabilities(183,128) (183,970)
Net cash from financing activities61,703,934  312,976 
Net increase in cash and cash equivalents45,391,927  2,363,597 
Effect of exchange rate changes on cash and cash equivalents999,820  903,700 
Cash and cash equivalents at beginning of period25,968,681  33,131,280 
Cash and cash equivalents at end of period72,360,428  36,398,578 
   

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. As a result, 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. Approximately 300 people have been treated with vilobelimab in clinical trials and the antibody has been shown to be well tolerated. Vilobelimab is currently being developed for various indications, including Hidradenitis Suppurativa, ANCA-associated vasculitis, Pyoderma Gangraenosum as well as COVID-19 pneumonia and Cutaneous Squamous Cell Carcinoma.

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.com.

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 preclinical development and clinical trials; 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 periodic filings 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. 


Primary Logo

Related Links: 
Author:
Copyright GlobeNewswire, Inc. 2016. All rights reserved.
You can register yourself on the website to receive press releases directly via e-mail to your own e-mail account.