InflaRx Reports Full Year 2020 Financial & Operating Results
- Submitted a Special Protocol Assessment to the FDA for Phase III program evaluating vilobelimab in Hidradenitis Suppurativa (HS) in Q1 2021
- Phase III trial in Severe COVID-19 is ongoing and recruiting patients
- Topline data from Phase II US trial in ANCA-Associated Vasculitis expected by mid-2021
- Cash, cash equivalents and financial assets of approximately
€81.4 million as of December 31, 2020 - Completed
$75M public offering in Q1 2021
JENA, Germany, March 25, 2021 (GLOBE NEWSWIRE) -- InflaRx (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today financial results for the year ended December 31, 2020.
Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx, commented: “The year 2020 was a challenging one for all of us dealing with a pandemic. As a physician and scientist, it has been extremely rewarding to see how quickly effective vaccines have been developed and are already in the arms of thousands of people. However, we continue to see a need for novel treatments for COVID-19 and similar future viral diseases. We are happy to be evaluating vilobelimab as a potential treatment to help severe COVID-19 patients and look forward to seeing those results, as well as results from ongoing trials in other disease areas, later this year.”
Prof. Riedemann continued: “We have submitted as planned a Special Protocol Assessment to the FDA to reach agreement on the path forward for our phase III plans with vilobelimab in hidradenitis suppurativa. We were excited to announce a new area of clinical development – oncology – and are on track to start our first cancer trial with vilobelimab in cutaneous squamous cell carcinoma in the second quarter of this year. I am also pleased that our team recently completed a
Recent Highlights and R&D Update
Issue of Share Capital
On March 1, 2021, InflaRx announced the closing of a public offering of common shares pursuant to which the Company sold 15,000,000 common shares and warrants to purchase up to 15,000,000 common shares. The common shares were sold at a price to the public of
Vilobelimab for Hidradenitis Suppurativa (HS)
InflaRx has submitted a Special Protocol Assessment (SPA) to the Food & Drug Administration (FDA) for the planned Phase III program in HS in the first quarter of 2021. Details on the Phase III design will be provided once agreement has been reached with the FDA.
In Europe, 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 a new primary endpoint, the International Hidradenitis Suppurativa Severity Score (“IHS4”). The Company is working diligently to address the additional feedback received to achieve alignment with the US strategy for a global Phase III development program in HS.
New data supporting the continued development of vilobelimab in the treatment of HS were presented in February 2021 at the 10th Conference of the European Hidradenitis Suppurativa Foundation e.V. (EHSF). The data from the SHINE Phase II trial showed that significantly elevated baseline C5a levels occurred in HS patients versus healthy volunteers. Data also showed that vilobelimab dose-dependently suppressed C5a levels over time accompanied by the previously reported reduction in inflammatory lesion counts and scores.
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 is currently ongoing with sites open in several countries in Europe and Latin America. Additional countries are in the process of being added. The study is enrolling as planned with a total goal of 360 patients. A blinded interim analysis is planned after 180 patients, with a potential early stop of the trial for efficacy or futility. Topline data from the trial are expected to be available by the end 2021.
Vilobelimab for ANCA-associated Vasculitis (AAV)
InflaRx reported the completion of enrollment in the European Phase II IXCHANGE study of vilobelimab in AAV in Q1 2021. Topline data from the randomized, double-blind, placebo-controlled trial with 57 patients are expected by the end of 2021.
Vilobelimab is also being studied in the US phase II IXPLORE study in patients with AAV. The main objective of this randomized, double-blind, placebo-controlled study is to evaluate the safety of vilobelimab, as this is the first time the drug is being administered to patients with AAV in the US. Topline results are expected by mid-2021.
Vilobelimab in cutaneous squamous cell carcinoma (cSCC)
The Company has recently announced plans to initiate an 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 non-comparative two-stage multi-national Phase II trial is expected to start enrolling patients in Q2 2021 with sites in Europe, the US and other countries. 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.
Vilobelimab in Pyoderma Gangraenosum
The Phase IIa open label trial continues to enroll patients in the higher dose groups. Promising initial data from the first five patients in the study were announced in 2020. Results from the higher dose groups are expected by the end of 2021.
Financial highlights 2020
Research and development expenses decreased by
This decrease is attributable to lower CRO and CMO costs from clinical trials in the amount of
In addition there was a
General and administrative expenses decreased by
Net financial result decreased by
Net loss for the year 2020 was
Net cash used in operating activities decreased to
Additional information regarding these results and other relevant information is included in the notes to 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 US Securities and Exchange Commission.
InflaRx N.V. and subsidiaries
Consolidated Statements of Operations and Comprehensive Loss for the Years
Ended December 31, 2020, 2019 and 2018
| in €, except for share information | 2020 | 2019 | 2018 | ||
| Operating Expenses | |||||
| Research and development expenses | (25,684,140) | (44,582,136) | (25,028,554) | ||
| General and administrative expenses | (8,467,203) | (12,501,048) | (12,786,869) | ||
| Total Operating Expenses | (34,151,343) | (57,083,184) | (37,815,422) | ||
| Other income | 221,748 | 400,253 | 303,860 | ||
| Other expenses | (13,209) | (85,242) | (4,802) | ||
| Operating Result | (33,942,804) | (56,768,173) | (37,516,364) | ||
| Finance income | 887,702 | 2,840,676 | 2,182,842 | ||
| Finance expenses | (26,000) | (22,265) | — | ||
| Foreign exchange result | (776,512) | 694,944 | 5,626,071 | ||
| Other financial result | (126,000) | — | (107,182) | ||
| Income Taxes | — | — | — | ||
| Loss for the Period | (33,983,614) | (53,254,817) | (29,814,634) | ||
| Share Information | |||||
| Weighted average number of shares outstanding | 27,064,902 | 26,004,519 | 25,095,027 | ||
| Loss per share (basic/diluted) | (1.26) | (2.05) | (1.19) | ||
| Loss for the Period | (33,983,614) | (53,254,817) | (29,814,634) | ||
| Other comprehensive income (loss) that may be reclassified to profit or loss in subsequent periods: | |||||
| Exchange differences on translation of foreign currency | (5,954,019) | 2,177,033 | 50,196 | ||
| Total Comprehensive Loss | (39,937,633) | (51,077,785) | (29,764,438) | ||
InflaRx N.V. and subsidiaries
Consolidated Statements of Financial Position as December 31, 2020 and 2019
| in € | 2020 | 2019 | |
| ASSETS | |||
| Non-current assets | |||
| Property and equipment* | 408,263 | 576,373 | |
| Right-of-use assets* | 546,694 | 836,924 | |
| Intangible assets | 350,183 | 452,400 | |
| Other assets | 353,522 | 452,217 | |
| Financial assets | 272,268 | 272,614 | |
| Total non-current assets | 1,930,930 | 2,590,528 | |
| Current assets | |||
| Current other assets* | 3,734,700 | 2,365,916 | |
| Income tax receivable* | 1,419,490 | 1,134,968 | |
| Financial assets | 55,162,033 | 82,353,867 | |
| Cash and cash equivalents | 25,968,681 | 33,131,280 | |
| Total current assets | 86,284,904 | 118,
InflaRx N.V.
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Pharmaceutical Preparation Manufacturing
Manufacturing
United States of America
Jena
About IFRXinflarx n.v., a clinical-stage biopharmaceutical company, discovers and develops inhibitors using c5a technology primarily in the germany and united states. its c5a is an inflammatory mediator that is involved in the enhancement of a variety of autoimmune and other inflammatory diseases. the company's lead product candidate is ifx-1, an intravenously delivered first-in-class anti-c5a monoclonal antibody, which completed the phase iib clinical trial for the treatment of hidradenitis suppurativa, a rare and chronic debilitating systemic inflammatory skin disease; to treat anca-associated vasculitis, a rare and life-threatening autoimmune disease; and for the treatment of pyoderma gangrenosum, a chronic inflammatory skin disorder, as well as developing ifx-1 for the treatment of oncological diseases. it also develops ifx-2 that is in pre-clinical development stage for the treatment of chronic inflammation and autoimmune diseases. inflarx n.v. has co-development agreement with beijing defe
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