InflaRx Reports First Quarter 2022 Financial and Operating Results and Provides Strategic Update
05/12/2022 - 07:30 AM
Quarter highlighted by progress with vilobelimab in several indications : Encouraging Phase III topline results reported in patients with severe COVID-19; discussions with regulatory authorities already underway Final data from Phase IIa open-label study in patients with pyoderma gangrenosum presented at 2022 AAD Annual Meeting; end-of-Phase II meeting with FDA scheduled for mid-2022 In Phase II trial in cutaneous squamous cell carcinoma, second dosing cohort of combination arm started; enrollment in monotherapy arm continuing with 8 patients enrolled with data expected in Q3 2022 Clinical development in hidradenitis suppurativa and ANCA-associated vasculitis halted for the time being I ntroduce d new pipeline program, INF904 , an oral small molecule inhibitor of C5aR ; planned to enter the clinic later this year Cash, cash equivalents and financial assets of approximately € 99.3 million as of March 31, 2022 , expected to fund operations well into H2 2024 JENA, Germany, May 12, 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 months ended March 31, 2022 and provided a business update.
Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx, commented: “Following a recent internal strategic review, we are announcing the Company’s updated key priorities and strategy. With final data now available from our Phase IIa study, we intend to move vilobelimab into a pivotal program in pyoderma gangrenosum and advance INF-904, our small molecule C5aR inhibitor, into first-in-human testing this year. Additionally, with the encouraging topline Phase III results we saw with vilobelimab in treating severe COVID-19 patients, we are now discussing our data with regulatory authorities to assess a potential path towards approval. With all of these important activities, we decided to halt the Phase III program in hidradenitis suppurativa and not to advance vilobelimab in AAV for the time being to prioritize the best use of our resources. We are excited about InflaRx’s potential to develop effective new treatments to improve the lives of patients suffering from neutrophil-driven inflammatory diseases.”
Recent Highlights – Progress with Vilobelimab in Several Indications
Severe COVID-19 : On March 31, 2022, InflaRx announced topline results from the Phase III part of the global Phase II/III PANAMO trial evaluating vilobelimab in mechanically ventilated patients with COVID-19. A total of 369 patients were enrolled. Vilobelimab treatment resulted in a relative reduction in 28-day all-cause mortality of 23.9% compared to placebo (vilobelimab 31.7% versus placebo 41.6% , p=0.094), which was not statistically significant using site-stratified Cox regression analysis as pre-specified in the final statistical analysis plan. At the recommendation of regulatory authorities, during the course of the trial, the Company changed the statistical analysis method for the primary endpoint. The original protocol-specified analysis would have resulted in a statistically significant p-value of 0.027. Additionally, logistic regression analyses of 28-day all-cause mortality resulted in p-values of <0.05 for 3 out of the 4 pre-specified analyses.
A pre-specified analysis of patients from Western European countries showed a relative reduction in 28-day all-cause mortality of 43% (p=0.014), suggesting an improvement in mortality in line with the reported Phase II data from the PANAMO trial.
Importantly, 60-day all-cause mortality, a key secondary endpoint, showed a continued reduction of mortality in the vilobelimab arm.
The Company is engaged in ongoing discussions with regulatory authorities to determine next steps towards a potential approval in this indication.
Pyoderma Gangrenosum (PG): 50% . During the follow-up period, ulcers remained closed two months after treatment completion in all but one patient, and a sustained suppression of C5a was observed for up to 20 days after the last dosing. With these compelling results, an end-of-Phase II meeting has been scheduled with the FDA for mid-2022 to discuss the pivotal program in this indication.
Cutaneous Squamous Cell Carcinoma (cSCC):
Enrollment continues in the monotherapy Arm A. Eight patients are now enrolled in this arm. Data are expected to be available in the third quarter of 2022.
In February 2022, the Company announced the start of the second dosing cohort of Arm B. The interim analysis in this arm 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 Arm B interim data, which are a prerequisite to move to the second stage of the trial, are expected to be available in the second half of 2023.
Hidradenitis Suppurativa (HS) and ANCA-Associated Vasculitis (AAV):
New Development Program Introduced
The Company 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.
F inancial H ighlights – Q 1 202 2
Research and Development Expenses
Research and development expenses for the three months ended March 31, 2022 increased by €5.6 million to €10.5 million compared to the three months ended March 31, 2021. This increase was primarily due to the completion of Phase III clinical development of vilobelimab for the treatment of COVID-19. This led to an increase of €3.1 million in manufacturing costs, which significantly contributed to an overall increase of €5.1 million in third-party expenses. The €0.5 million increase in personnel expenses was mainly related to equity-settled share-based compensation.
General and Administrative Expenses
General and administrative expenses increased by €1.4 million to €4.4 million for the three months ended March 31, 2022, from €3.0 million for the three months ended March 31, 2021. This increase is attributable to higher personnel expenses from equity-settled share-based compensation recognized in personnel expenses of €0.4 million . Additionally, legal, consulting and other expenses increased to €1.9 million for the three months ended March 31, 2022, from €1.0 million for the three months ended March 31, 2021.
Net Financial Result
Net financial result decreased by €0.9 million to €0.9 million for the three months ended March 31, 2022, from €1.8 million for the three months ended March 31, 2021. This decrease is mainly attributable to lower foreign exchange gains, which decreased by €1.3 million , and higher foreign exchange losses of €0.3 million . Other finance expenses for the three months ended March 31, 2022 included a €48 thousand gain from a reduction in the allowance for expected credit loss on marketable securities.
Net Loss
Net loss for the three months ended March 31, 2022 was €14.0 million , compared to €6.1 million for the three months ended March 31, 2021.
On March 31, 2022, the Company’s total funds available were approximately €99.3 million , composed of cash and cash equivalents of €40.1 million and financial assets of €59.2 million . With the Company’s adjusted strategy, these funds are expected to finance operations well into the second half of 2024.
Net Cash Used in Operating Activities
Net cash used in operating activities increased to €12.9 million in the three months ended March 31, 2022, from €10.4 million in the three months ended March 31, 2021.
Additional information regarding these results and other relevant information is included in the notes to the unaudited interim condensed consolidated financial statements as of March 31, 2022 and the three months ended March 31, 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.
InflaRx N.V. and subsidiaries Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss for the three months ended March 31, 202 2 and 20 2 1
For the three months ended March 31 , (in €, except for share data) 202 2 (unaudited) 20 2 1 (unaudited) Operating Expenses Research and development expenses (10,471,923 ) (4,906,885 ) General and administrative expenses (4,387,443 ) (3,022,338 ) Total Operating Expenses (14,859,366 ) (7,929,224 ) Other income 1,593 5,462 Other expenses (565 ) (565 ) Operating Result (14,858,338 ) (7,924,327 ) Finance income 27,962 22,962 Finance expenses (24,586 ) (3,684 ) Foreign exchange result 727,933 1,731,671 Other financial result 125,000 48,000 Income Taxes — — Loss for the Period (14,002,030 ) (6,125,378 ) Share Information Weighted average number of shares outstanding 44,203,763 33,807,774 Loss per share (basic/diluted) (0.32 ) (0.18 ) Loss for the Period (14,002,030 ) (6,125,378 ) Other comprehensive income (loss) that may be reclassified to profit or loss in subsequent periods: Exchange differences on translation of foreign currency 1,309,875 3,504,699 Total Comprehensive Loss (12,692,154 ) (2,620,679 )
InflaRx N.V. and subsidiar ies Unaudited Condensed Consolidated Statements of Financial Position as of March 31, 202 2 and Decemb er 31, 20 2 1
March 3 1 , 202 2 (unaudited) Decem ber 31, 20 2 1 ASSETS Non-current assets Property and equipment 251,713 274,373 Right-of-use assets 1,314,691 1,408,078 Intangible assets 209,818 235,216 Other assets 331,539 336,566 Financial assets 9,272,352 27,206,990 Total non-current assets 11,380,114 29,461,224 Current assets Current other assets 12,521,363 10,983,458 Current tax assets 1,154,604 1,282,177 Financial assets 49,925,236 57,162,266 Cash and cash equivalents 40,096,286 26,249,995 Total current assets 103,697,489 95,677,896 TOTAL ASSETS 115,077,603 125,139,120 EQUITY AND LIABILITIES Equity Issued capital 5,304,452 5,304,452 Share premium 280,310,744 280,310,744 Other capital reserves 33,121,984 30,591,209 Accumulated deficit (227,977,709 ) (213,975,679 ) Other components of equity 4,360,146 3,050,270 Total equity 95,119,617 105,280,996 Non-current liabilities Lease liabilities 973,905 1,066,354 Other liabilities 35,628 35,019 Total non-current liabilities 1,009,533 1,101,373 Current liabilities Trade and other payables 9,502,770 8,574,244 Liabilities from government grants received 8,300,000 8,300,000 Lease liabilities 369,676 366,171 Employee benefits 644,646 1,378,130 Other financial liabilities 131,362 138,206 Total current liabilities 18,948,452 18,756,751 Total Liabilities 19,957,985 19,858,124 TOTAL EQUITY AND LIABILITIES 115,077,603 125,139,120
InflaRx N.V. and subsidiar ies Unaudited Condensed Consolidated Statements of Changes in Shareholders’ Equity for the three months ended March 31, 202 2 and 20 2 1
(in €, except for share data) Issued Share premium Other capital re serves Ac cu mulated Other compo nents Total equity Balance as of January 1, 202 2 5,304,452 280,310,744 30,591,209 (213,975,679 ) 3,050,271 105,280,996 Loss for the period — — — (14,002,030 ) — (14,002,030 ) Exchange differences on — — — — 1,309,875 1,309,875 Total comprehensive loss — — — (14,002,030 ) 1,309,875 (12,692,155 ) Equity-settled share-based payments — — 2,530,775 — — 2,530,775 Balance as of March 31, 202 2 5,304,452 280,310,744 33,121,984 (227,977,709 ) 4,360,146 95,119,617 Balance as of January 1, 202 1 3 , 387 , 410 220 , 289 , 876 26 , 259 , 004 (168 , 345 , 620 ) (3 , 726 , 790 ) 77 , 863 , 880 Loss for the period — — — (6,125,378 ) — (6,125,378 ) Exchange differences — — — — 3,504,699 3,504,699 Total comprehensive loss — — — (6 , 125 , 378 ) 3 , 504 , 699 (2 , 620 , 679 ) 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 payments — — 1,721,270 — — 1,721,270 Share options exercised 41,741 921,994 — — — 963,735 Balance as of March 31, 202 1 5 , 302 , 354 280 , 261 , 994 27 , 980 , 274 (174 , 470 , 998 ) (222 , 091 ) 138 , 851 , 532
InflaRx N.V. and subsidiar ies Unaudited Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 202 2 and 20 2 1
For the three months ended March 31, 202 2 (unaudited) For the three months ended March 3 1 , 20 2 1 (unaudited) Operating activities Loss for the period (14,002,030 ) (6,125,378 ) Adjustments for: Depreciation & amortization of property and equipment, right-of-use assets and intangible assets 153,321 168,343 Net finance income (856,308 ) (1,798,949 ) Share-based payment expense 2,530,775 1,721,270 Net foreign exchange differences 135,826 193,847 Changes in: Other assets (1,405,328 ) (2,739,152 ) Employee benefits (732,876 ) (952,820 ) Other liabilities (6,844 ) 240,229 Trade and other payables 928,526 (1,150,252 ) Interest received 420,916 33,189 Interest paid (24,641 ) (3,780 ) Net cash used in operating activities (12,858,662 ) (10,413,453 ) Investing activities Purchase of intangible assets, property and equipment (7,828 ) (17,062 ) Purchase of current financial assets — (14,985,026 ) Proceeds from the maturity of financial assets 26,488,950 13,952,522 Net cash from / (used in) investing activities 26 , 481 , 122 (1,049,566 ) 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 (90,806 ) (90,716 ) Net cash from/ (used in) financing activities (90,806 ) 61,796,346 Net increase/(decrease) in cash and cash equivalents 13,531,653 50,333,328 Effect of exchange rate changes on cash and cash equivalents 314,639 2,432,654 Cash and cash equivalents at beginning of period 26,249,995 25,968,681 Cash and cash equivalents at end of period 40,096,286 78,734,662
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.com .
The COVID-19 related work described herein 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.
Jordan Zwick – Chief Strategy Officer
MC Services AG
Katja Arnold, Laurie Doyle, Andreas Jungfer
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, development of vilobelimab for mechanically ventilated COVID-19 patients; future analysis of our Phase II/III PANAMO trial and interactions with regulators regarding the results of the trial and potential regulatory approval pathways; the impact of the COVID-19 pandemic on us; 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; decisions regarding the strategic direction of our company; 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; our status as an emerging growth company and/or foreign private issuer; 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.
