- Single ascending dose (SAD) Phase I data confirm best-in-class potential of orally available C5aR inhibitor INF904; multiple ascending dose (MAD) part ongoing
- Six clinical sites initiated; first patients screened in Phase III trial of vilobelimab in pyoderma gangrenosum (PG)
- FDA regulatory pathway towards BLA in broader acute respiratory distress syndrome (ARDS) indication discussed in encouraging FDA Type C meeting
- MAA for vilobelimab for treatment of SARS-CoV-2 induced septic ARDS in critically ill COVID-19 patients submitted and validated by EMA
- Update on development of vilobelimab in cutaneous squamous cell carcinoma (cSCC)
- First commercial sales for Gohibic (vilobelimab) recorded in the third quarter 2023
- Cash, cash equivalents and marketable securities of €113 million, expected to fund operations at least into 2026
JENA,
“In recent months, we have made exciting progress with both vilobelimab and our small molecule C5aR inhibitor INF904. With the commercial launch of Gohibic (vilobelimab) in
He continued: “With INF904, we set out to develop an orally bioavailable inhibitor of C5a signaling with best-in-class potential, and the initial data from our Phase I trial strongly support this. We look forward to seeing additional data from this ongoing study with this promising treatment candidate. Ultimately, we are planning to develop INF904 in a chronic inflammatory condition and dedicate more resources towards this exciting new development going forward.”
Recent Highlights and Business Update
INF904 – Positive Topline Results from Single Ascending Dose (SAD) Part of Phase I Trial Support Best-in-Class Potential as Orally Administered C5aR Inhibitor
InflaRx recently announced positive topline results from the SAD part of a randomized, double-blind, placebo-controlled Phase I trial in healthy volunteers to assess the safety, tolerability and pharmacokinetic / pharmacodynamic (PK/PD) properties of InflaRx’s low molecular weight C5aR inhibitor INF904.
The results showed that INF904 was well tolerated and resulted in no safety signals of concern in single doses ranging from 3 mg to 240 mg. Analysis of INF904 in subject plasma samples revealed a favorable PK profile that, at the 30 mg dose and above, surpassed the values for systemic exposure (AUClast) and maximum concentration (Cmax) of published Phase I data from the only marketed comparator. Further, ex vivo assays showed that INF904 achieved the set goal for effective C5aR control at disease relevant C5a levels.
The multiple ascending dose (MAD) part of the Phase 1 trial is ongoing, and the Company expects to present results from the approximately 24 healthy volunteers enrolled in this part of the study at the beginning of 2024. InflaRx is currently preparing to initiate additional required pre-clinical studies, including chronic toxicology studies, for the future clinical development of INF904 in chronic inflammatory diseases. In parallel, the Company is evaluating selected potential indications for future development.
Development of Vilobelimab in Pyoderma Gangrenosum (PG):
InflaRx is well underway in a pivotal Phase III study with vilobelimab for the treatment of ulcerative PG. As of today, InflaRx has initiated the first six clinical sites in
The study has an adaptive trial design with an interim analysis blinded for the sponsor and investigators planned upon enrollment of approximately 30 patients (15 per arm). Depending on the results of the interim analysis, the trial sample size will be adapted, or the trial will be stopped due to futility. The enrollment period is projected to be at least two years, depending on the total trial size after sample size adaptation.
Marketing Authorization Application (MAA) for Vilobelimab for Treatment of Critically Ill COVID-19 Patients under Review by
This summer, the Company submitted an MAA for the treatment of adult patients with SARS-CoV-2 induced septic acute respiratory distress syndrome (ARDS) receiving invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO) to the EMA. The EMA has validated the MAA, which means that the application is now under regulatory review by the
Commercial Launch of Gohibic (vilobelimab) for the Treatment of Critically Ill COVID-19 Patients following Emergency Use Authorization (EUA) in the United States:
In
InflaRx is currently developing its commercial strategic plan and seeking to increase awareness of Gohibic (vilobelimab). In parallel, the Company is also exploring paths to gain full market approval via a biologics license application (BLA) in
InflaRx is conducting an open-label, multicenter Phase II study, evaluating vilobelimab in two study arms - as a monotherapy (Arm A) and in combination with pembrolizumab (Arm B) - in patients with programmed cell death protein 1 (PD-1) or programmed cell death ligand 1 (PD-L1) inhibitor in resistant/refractory, locally advanced or metastatic cSCC. The main objectives of this trial are to assess the safety and antitumor activity of vilobelimab in the monotherapy arm and to assess the maximum tolerated or recommended dose of vilobelimab and the safety and antitumor activity of this drug pair in the combination arm.
An interim analysis of ten evaluable patients in the monotherapy Arm A showed first evaluable signals of efficacy. In Arm B, 15 patients were enrolled (3+6+6 in three dosing cohorts). Before proceeding with the second stage of the study in Arm B, the interim efficacy data were assessed and showed two partial responses - one patient in the second cohort and one patient in the third cohort. Both patients are still on treatment.
While these results are encouraging, the recent emergence of new alternative treatments for cSCC and the recommendation by the Company’s
Patients who are currently still in treatment will be treated for up to 24 months according to the protocol; however, no new patients will be enrolled in the study and clinical sites in which no patients are currently being treated will be closed down. The decision to wind down this clinical study does not preclude InflaRx from developing vilobelimab or INF904 in cSCC or similar oncology indications in the future.
Financing Activities
In
Dr.
Financial Highlights – Q3 2023
Revenue
In Q3 2023, the Company realized revenues from product sales for the first time since its inception. Revenues reported are actual sales to end customers (hospitals). Sales to distributors, of which €2.9 million were incurred in Q3, do not constitute revenue for the Company under IFRS 15 but rather were recorded as other financial liability as of
Cost of Sales
Cost of sales recognized during the nine months ended
Cost of sales during the first nine months of 2023 mainly consisted of write-downs of inventories that will expire prior to their expected sale. Early product batches, capitalized in inventory, were produced with material which had been manufactured in previous years. The inventory write-down for the nine months ended
Sales and Marketing Expenses
In the nine months ended
Research and Development Expenses
Research and development expenses incurred for the nine months ended
General and Administrative Expenses
General and administrative expenses decreased by €1.8 million to €10.0 million for the nine months ended
Other Income
Other income decreased by €3.0 million to €13.4 million for the nine months ended
Net Financial Result
Net financial result increased by €1.8 million to €4.9 million for the nine months ended
Net Loss
Net loss for the first nine months of 2023 amounted to €26.7 million, compared to €21.5 million in the first nine months of 2022.
Net cash used in operating activities for the first nine months of 2023 decreased to €26.9 million from €28.5 million for the comparable period in 2022.
Liquidity and Capital Resources
As of
Additional Financial Information
Additional information regarding these results and other relevant information is included in the notes to the unaudited interim condensed consolidated financial statements as of
Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and nine months ended
For the three months ended | For the nine months ended | |||||||
2023 (unaudited) | 2022 (unaudited) | 2023 (unaudited) | 2022 (unaudited) | |||||
(in €, except for share data) | ||||||||
Revenues | 60,803 | — | 60,803 | — | ||||
Cost of Sales | (255,116) | — | (255,116) | — | ||||
Gross profit | (194,313) | — | (194,313) | — | ||||
Sales and marketing expenses | (1,562,473) | — | (1,838,524) | — | ||||
Research and development expenses | (7,305,541) | (7,537,350) | (32,957,044) | (29,190,231) | ||||
General and administrative expenses | (2,897,732) | (3,087,285) | (10,047,091) | (11,821,694) | ||||
Other income | 808,866 | 2,030,406 | 13,437,963 | 16,473,540 | ||||
Other expenses | 339 | — | (2,851) | (844) | ||||
Operating Result | (11,150,854) | (8,594,230) | (31,601,861) | (24,539,229) | ||||
Finance income | 1,189,826 | 199,758 | 2,732,873 | 310,121 | ||||
Finance expenses | (4,897) | (6,845) | (15,476) | (39,376) | ||||
Foreign exchange result | 2,292,938 | 882,370 | 1,923,274 | 3,173,883 | ||||
Other financial result | 221,577 | (402,724) | 223,818 | (363,724) | ||||
Income Taxes | — | — | — | — | ||||
Income (Loss) for the Period | (7,451,410) | (7,921,671) | (26,737,373) | (21,458,325) | ||||
Other comprehensive income (loss) that may be reclassified to profit or loss in subsequent periods: | ||||||||
Exchange differences on translation of foreign currency | 73,574 | 4,317,134 | 56,459 | 10,035,949 | ||||
Total Comprehensive Income (Loss) | (7,377,836) | (3,604,538) | (26,680,914) | (11,422,376) | ||||
Share Information (based on Income (Loss) for the Period) | ||||||||
Weighted average number of shares outstanding | 58,883,272 | 44,203,763 | 53,598,594 | 44,203,763 | ||||
Income (Loss) per share (basic/diluted) | (0.13) | (0.18) | (0.50) | (0.49) |
Unaudited Condensed Consolidated Statements of Financial Position as of
(unaudited) | ||||
(in €) | ||||
ASSETS | ||||
Non-current assets | ||||
Property and equipment | 298,344 | 328,920 | ||
Right-of-use assets | 1,076,402 | 1,311,809 | ||
Intangible assets | 66,734 | 138,905 | ||
Other assets | 270,526 | 308,066 | ||
Financial assets | 237,564 | 2,900,902 | ||
Total non-current assets | 1,949,570 | 4,988,602 | ||
Current assets | ||||
Inventories | 1,639,490 | — | ||
Current other assets | 7,779,994 | 14,170,510 | ||
Current tax assets | 3,398,481 | 1,432,087 | ||
Financial assets from government grants | 1,164,217 | 732,971 | ||
Other financial assets | 91,857,945 | 64,810,135 | ||
Cash and cash equivalents | 21,695,607 | 16,265,355 | ||
Total current assets | 127,535,734 | 97,411,058 | ||
TOTAL ASSETS | 129,485,304 | 102,399,660 | ||
EQUITY AND LIABILITIES | ||||
Equity | ||||
Issued capital | 7,065,993 | 5,364,452 | ||
Share premium | 334,211,338 | 282,552,633 | ||
Other capital reserves | 39,597,055 | 36,635,564 | ||
Accumulated deficit | (270,197,663) | (243,460,290) | ||
Other components of equity | 7,313,540 | 7,257,081 | ||
Total equity | 117,990,262 | 88,349,440 | ||
Non-current liabilities | ||||
Lease liabilities | 771,814 | 987,307 | ||
Other liabilities | 36,877 | 36,877 | ||
Total non-current liabilities | 808,691 | 1,024,184 | ||
Current liabilities | ||||
Trade and other payables | 5,999,200 | 4,987,538 | ||
Liabilities from government grants | — | 6,209,266 | ||
Lease liabilities | 354,151 | 369,376 | ||
Employee benefits | 1,285,355 | 1,312,248 | ||
Other liabilities | 3,047,646 | 147,608 | ||
Total current liabilities | 10,686,351 | 13,026,036 | ||
Total Liabilities | 11,495,042 | 14,050,220 | ||
TOTAL EQUITY AND LIABILITIES | 129,485,304 | 102,399,660 | ||
Unaudited Condensed Consolidated Statements of Changes in Shareholders’ Equity for the nine months ended
(in €) | Issued capital | Share premium | Other capital reserves | Accumulated deficit | Other components of equity | Total equity | ||||||
Balance as of | 5,364,452 | 282,552,633 | 36,635,564 | (243,460,290) | 7,257,081 | 88,349,440 | ||||||
Loss for the period | — | — | — | (26,737,373) | — | (26,737,373) | ||||||
Exchange differences on translation of foreign currency | — | — | — | — | 56,459 | 56,459 | ||||||
Total comprehensive loss | — | — | — | (26,737,373) | 56,459 | (26,680,914) | ||||||
Issuance of common shares | 1,687,110 | 54,796,819 | — | — | — | 56,483,929 | ||||||
Transaction costs | — | (3,360,626) | — | — | — | (3,360,626) | ||||||
Equity-settled share-based payments | — | — | 2,961,491 | — | — | 2,961,491 | ||||||
Share options exercised | 14,431 | 222,512 | — | — | — | 236,943 | ||||||
Balance as of | 7,065,993 | 334,211,338 | 39,597,055 | (270,197,663) | 7,313,540 | 117,990,262 | ||||||
Balance as of | 5,304,452 | 280,310,744 | 30,591,209 | (213,975,679) | 3,050,271 | 105,280,996 | ||||||
Loss for the period | — | — | — | (21,458,325) | — | (21,458,325) | ||||||
Exchange differences on translation of foreign currency | — | — | — | — | 10,035,949 | 10,035,949 | ||||||
Total comprehensive loss | — | — | — | (21,458,325) | 10,035,949 | (11,422,376) | ||||||
Equity-settled share-based payments | — | — | 5,581,021 | — | — | 5,581,021 | ||||||
Balance as of | 5,304,452 | 280,310,744 | 36,172,229 | (235,434,004) | 13,086,220 | 99,439,640 | ||||||
Unaudited Condensed Consolidated Statements of Cash Flows for the nine months ended
For the nine months ended | ||||
2023 (unaudited) | 2022 (unaudited) | |||
(in €) | ||||
Operating activities | ||||
Loss for the period | (26,737,373) | (21,458,325) | ||
Adjustments for: | ||||
Depreciation & amortization of property and equipment, right-of-use assets and intangible assets | 432,248 | 448,323 | ||
Net finance income | (4,864,488) | (3,080,904) | ||
Share-based payment expense | 2,961,491 | 5,581,021 | ||
Net foreign exchange differences | (82,574) | 189,088 | ||
Changes in: | ||||
Financial assets from government grants | (431,246) | (5,954,754) | ||
Other assets | 4,468,239 | 3,087,177 | ||
Employee benefits | (26,893) | (221,982) | ||
Other liabilities | 2,893,461 | 5,061 | ||
Liabilities from government grants received | (6,209,266) | (6,849,415) | ||
Trade and other payables | 1,011,662 | (1,135,817) | ||
Inventories | (1,639,490) | — | ||
Interest received | 1,302,391 | 903,647 | ||
Interest paid | (15,773) | (38,978) | ||
Net cash used in operating activities | (26,937,611) | (28,525,857) | ||
Investing activities | ||||
Purchase of intangible assets, property and equipment | (45,942) | (17,908) | ||
Purchase of current financial assets | (91,590,134) | (47,031,216) | ||
Proceeds from the maturity of financial assets | 71,113,455 | 64,600,049 | ||
Net cash from/(used in) investing activities | (20,522,621) | 17,550,925 | ||
Financing activities | ||||
Proceeds from issuance of common shares | 56,483,929 | — | ||
Transaction costs from issuance of common shares | (3,360,626) | — | ||
Proceeds from exercise of share options | 236,943 | — | ||
Repayment of lease liabilities | (279,075) | (273,092) | ||
Net cash from/(used in) financing activities | 53,081,170 | (273,092) | ||
Net increase/(decrease) in cash and cash equivalents | 5,620,938 | (11,248,024) | ||
Effect of exchange rate changes on cash and cash equivalents | (190,686) | 2,976,033 | ||
Cash and cash equivalents at beginning of period | 16,265,355 | 26,249,995 | ||
Cash and cash equivalents at end of period | 21,695,607 | 17,978,003 | ||
About InflaRx
InflaRx (Nasdaq: IFRX) is a biotechnology company pioneering anti-inflammatory therapeutics by applying its proprietary anti-C5a and anti-C5aR technologies to discover, develop and commercialize first-in-class, potent and specific inhibitors of the complement activation factor C5a and its receptor C5aR. C5a is a powerful inflammatory mediator involved in the progression of a wide variety of inflammatory diseases. InflaRx’s lead product candidate, vilobelimab, is a novel, intravenously delivered, first-in-class, anti-C5a monoclonal antibody that selectively binds to free C5a and has demonstrated disease-modifying clinical activity and tolerability in multiple clinical studies in different indications. InflaRx was founded in 2007, and the group has offices and subsidiaries in Jena and
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:
Email: IR@inflarx.de
Email: inflarx@mc-services.eu
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,” “estimate,” “believe,” “predict,” “potential” or “continue,” among others. 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, the receptiveness of Gohibic (vilobelimab) as a treatment for COVID-19 by COVID-19 patients and
Source:
2023 GlobeNewswire, Inc., source