InflaRx Reports Q3 2020 Financial & Operating Results
- Initiated Phase III part of the Phase II/III adaptive, randomized, controlled trial in patients with severe COVID-19 induced pneumonia
- Published encouraging data from Phase II part of COVID-19 trial in The Lancet Rheumatology
- Announced leadership team additions
- Cash, cash equivalents and financial assets of approximately €95.7 million as of September 30, 2020
JENA, Germany, Oct. 29, 2020 (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 three and nine months ended September 30, 2020.
“With cases of COVID-19 on the rise throughout the world, there remains an urgent need to find safe and efficacious treatments for critically ill patients. Thus, we are highly focused on advancing our ongoing Phase III trial with IFX-1 in patients with severe COVID-19 induced pneumonia,” said Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx. “In addition, we are continuing to move forward IFX-1 in development for important inflammatory indications, including hidradenitis suppurativa, pyoderma gangraenosum and ANCA-associated vasculitis, all disease areas where patients are in need of better treatment options.”
Corporate and R&D Highlights
- Leadership appointments: In September 2020, InflaRx announced the appointment of Thomas Taapken, Ph.D. as Chief Financial Officer, and Jordan Zwick was promoted to the newly created position of Chief Strategy Officer.
- IFX-1 in COVID-19 induced pneumonia: In September 2020, InflaRx announced the start of the global Phase III part of its Phase II/III trial with IFX-1 in severe COVID-19 induced pneumonia with the initiation of the first clinical site in the Netherlands. In parallel, the German regulatory authority, the Paul-Ehrlich-Institut (PEI), approved the Phase III clinical trial in Germany. The trial is currently enrolling, and patients are undergoing treatment. The randomized, double-blinded and placebo-controlled Phase III part of the Phase II/III trial is planned to enroll approximately 360 early intubated, critically ill patients with COVID-19 induced pneumonia across sites in the US, EU, South America and other regions. Patients are being randomized 1:1 to receive either IFX-1 or placebo; all patients will receive standard of care. The primary endpoint is 28-day all-cause mortality; key secondary endpoints will include assessment of organ support and disease improvement. An interim analysis is planned after enrollment of 180 patients, with a potential for an early stop for efficacy or futility. Also in September, encouraging data from the Phase II part of the study were published in the peer-reviewed journal, The Lancet Rheumatology.
- IFX-1 in Hidradenitis Suppurativa (HS): The Company is assessing different strategies for a potential pathway to regulatory approval for IFX-1 in the United States and plans to engage with the Food & Drug Administration (FDA) on next steps. In Europe, InflaRx is working diligently to address the feedback received in Scientific Advice from the European Medicines Agency (EMA) and analyzing the strategy for its Phase III development program for the use of IFX-1 in the treatment of HS.
- IFX-1 in Pyoderma Gangraenosum (PG): The Phase IIa open label trial continues to enroll patients in the higher dose groups. Additional clinical trial sites continue to be opened to support enrollment. Results from the higher dose groups are expected in 2021.
- IFX-1 in ANCA-associated vasculitis (AAV): In the US IXPLORE study, all patients have completed treatment. Data is expected in the first half of 2021. In the European Phase II IXCHANGE trial, Part 2 continues to enroll patients, with approximately half of the targeted 25 patients enrolled. Final results are expected in 2021.
- IFX-1 in oncology: Activities are ongoing for the Phase IIa oncology program, with expected initiation in the first half of 2021.
Financial highlights – Q3 2020
Research and development expenses incurred for the nine months ended September 30, 2020 decreased over the corresponding period in 2019 by €13.7 million. This decline was primarily due to lower contribution of expense in the period from the Phase IIb clinical development of IFX-1 in HS since this study was completed in 2019, offset by the COVID-19 trial expenses. These two factors led to €6.6 million of lower manufacturing costs which contributed to an overall decline in third-party expenses of €11.5 million. The €2.0 million decrease in personnel expenses is mainly caused by equity-settled share-based compensation.
General and administrative expenses decreased by €3.4 million to €6.1 million for the nine months ended September 30, 2020, from €9.4 million for the nine months ended September 30, 2019. This decrease is largely attributable to lower expenses associated with equity-settled share-based compensation recognized in personnel expenses (€3.0 million). Furthermore, legal, consulting and other expenses decreased by €0.4 million to €3.2 million for the nine months ended September 30, 2020, from €3.6 million for the nine months ended September 30, 2019. In 2019, consulting expenses were higher due to a one-time strategic project in June 2019. Other expenses in 2020 include increased D&O insurance costs compared to the respective nine month period in 2019.
Net financial result decreased by €2.7 million to €0.6 million for the nine months ended September 30, 2020, from €3.3 million for the nine months ended September 30, 2019. This decrease is mainly attributable to higher foreign exchange losses, which increased by €1.7 million partially compensated with foreign exchange gains (€0.5 million) while interest on marketable securities declined by €1.5 million.
Net loss for the nine months ended September 30, 2020 was €25.1 million , compared to €39.6 million for the nine months ended September 30, 2019. On September 30, 2020, the Company’s total funds available were approximately €95.7 million, composed of cash and cash equivalents (€44.8 million) and financial assets (€50.8 million).
Net cash used in operating activities decreased to €26.8 million in the nine months ended September 30, 2020, from €27.0 million in the nine months ended September 30, 2019. The decrease of cash expenses, such as third-party expenses for manufacturing and clinical trials for our lead program IFX-1 was nearly offset by €12.3 million lower payments on trade liabilities in the nine months ended September 30, 2019.
Additional information regarding these results and other relevant information is included in the notes to the unaudited Condensed Consolidated Financial Statements as of September 30, 2020, as well as the financial statements as of December 31, 2019 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 nine months ended September 30, 2020 and 2019
For the three months ended September 30, | For the nine months ended September 30, | ||||||||||
(in €, except for share data) | 2020 (unaudited) | 2019 (unaudited) | 2020 (unaudited) | 2019 (unaudited) | |||||||
Operating Expenses | |||||||||||
Research and development expenses | (5,246,536 | ) | (13,405,646 | ) | (19,901,661 | ) | (33,598,018 | ) | |||
General and administrative expenses | (1,166,070 | ) | (2,490,245 | ) | (6,057,767 | ) | (9,439,080 | ) | |||
Total Operating Expenses | (6,412,606 | ) | (15,895,891 | ) | (25,959,428 | ) | (43,037,098 | ) | |||
Other income | 3,471 | 126,559 | 200,763 | 194,261 | |||||||
Other expenses | (13 | ) | (838 | ) | (9,184 | ) | (83,907 | ) | |||
Operating Result | (6,409,148 | ) | (15,770,170 | ) | (25,767,849 | ) | (42,926,744 | ) | |||
Finance income | 1,325,367 | 2,029,992 | 3,593,803 | 4,527,952 | |||||||
Finance expenses | (1,775,183 | ) | (761,268 | ) | (2,951,147 | ) | (1,211,366 | ) | |||
Net Financial Result | (449,816 | ) | 1,268,725 | 642,656 | 3,316,586 | ||||||
Loss for the Period | (6,858,964 | ) | (14,501,446 | ) | (25,125,193 | ) | (39,610,157 | ) | |||
Share Information | |||||||||||
Weighted average number of shares outstanding | 27,733,778 | 25,982,754 | 26,674,233 | 25,970,571 | |||||||
Loss per share (basic/diluted) | (0.25 | ) | € (0.56) | (0.94 | ) | € (1.53) | |||||
Loss for the Period | (6,858,964 | ) | (14,501,446 | ) | (25,125,193 | ) | (39,610,157 | ) | |||
Other comprehensive income (loss) that may be reclassified to profit or loss in subsequent periods: | |||||||||||
Exchange differences on translation of foreign currency | (3,022,687 | ) | 4,988,141 | (2,761,792 | ) | 5,683,610 | |||||
Total Comprehensive Loss | (9,881,651 | ) | (9,513,305 | ) | (27,886,985 | ) | (33,926,548 | ) | |||
InflaRx N.V. and subsidiaries
Unaudited Condensed Consolidated Statements of Financial Position
as of September 30, 2020 and December 31, 2019
in € | September 30, 2020 (unaudited) | December 31, 2019 | |||
ASSETS | |||||
Non-current assets | |||||
Property, plant and equipment | 467,937 | 576,373 | |||
Right-of-use assets | 623,452 | 836,924 | |||
Intangible assets | 379,811 | 452,400 | |||
Other assets | 385,837 | 452,217 | |||
Financial assets | 272,448 | 272,614 | |||
Total non-current assets | 2,129,485 | 2,590,528 | |||
Current assets | |||||
Other assets | 3,794,075 | 3,500,884 | |||
Financial assets | 50,563,814 | 82,353,867 | |||
Cash and cash equivalents | 44,834,089 | 33,131,280 | |||
Total current assets | 99,191,977 | 118,986,031 | |||
TOTAL ASSETS | 101,321,462 | 121,576,558 | |||
EQUITY AND LIABILITIES | |||||
Equity | |||||
Issued capital | 3,387,410 | 3,132,631 | |||
Share premium | 220,289,876 | 211,006,606 | |||
Other capital reserves | 26,039,651 | 25,142,213 | |||
Accumulated deficit | (159,487,199 | ) | (134,362,006 | ) | |
Other components of equity | (534,564 | ) | 2,227,228 | ||
Total equity | 89,695,174 | 107,146,673 | |||
Non-current liabilities | |||||
Lease liabilities | 123,053 | 330,745 | |||
Other non-financial liabilities | 35,488 | 39,013 | |||
Total non-current liabilities | 158,541 | 369,758 | |||
Current liabilities | |||||
Trade and other payables | 9,998,452 | 12,413,662 | |||
Lease liabilities | 511,652 | 515,203 | |||
Employee benefits | 799,812 | 975,629 | |||
Social security, other taxes and other non-financial liabilities | 121,830 | 105,634 | |||
Provisions | 36,000 | 50,000 | |||
Total current liabilities | 11,467,747 | 14,060,128 | |||
Total Liabilities | 11,626,288 | 14,429,886 | |||
TOTAL EQUITY AND LIABILITIES | 101,321,462 | 121,576,558 | |||
InflaRx N.V. and subsidiaries
Unaudited Condensed Consolidated Statements of Changes in Shareholders’ Equity for the nine months ended September 30, 2020 and 2019
(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, 2020 | 3,132,631 | 211,006,606 | 25,142,213 | (134,362,006 | ) | 2,227,228 | 107,146,673 | ||||||||
Loss for the period | — | — | — | (25,125,193 | ) | — | (25,125,193 | ) | |||||||
Exchange differences on translation of foreign currency | — | — |
By: GlobeNewswire
- 29 Oct 2020
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