InflaRx Full Year 2017 Financial & Operating Results

InflaRx (Nas­daq: IFRX), a bio­phar­ma­ceu­ti­cal com­pany devel­op­ing inno­v­a­tive ther­a­peu­tics to treat life-threat­en­ing inflam­ma­tory dis­eases by tar­get­ing the com­ple­ment sys­tem, a key com­po­nent of the innate immune sys­tem, announced today finan­cial results for the year ended Decem­ber 31, 2017.

“2017 has been a trans­for­ma­tional year for InflaRx, high­lighted by mul­ti­ple achieve­ments in our pipeline and com­ple­tion of two impor­tant financ­ings that will fuel future devel­op­ment of our key ther­a­peu­tic can­di­dates,” said Prof. Niels C. Riede­mann, Chief Exec­u­tive Offi­cer. “Specif­i­cally, we demon­strated effi­cacy with our lead prod­uct, IFX‑1, in a phase IIa clin­i­cal trial to treat Hidradeni­tis Sup­pu­ra­tiva (HS), and com­pleted a US$55 mil­lion pri­vate financ­ing in Octo­ber, fol­lowed by a suc­cess­ful US$106 mil­lion Nas­daq IPO in Novem­ber. These financ­ings pro­vide the resources we need to drive our pipeline forward.”

In Jan­u­ary 2018, the U.S. Food and Drug Admin­is­tra­tion approved the IND appli­ca­tion for IFX‑1, a com­ple­ment C5a inhibitor, in HS. Sub­se­quently, InflaRx ini­ti­ated phase IIb clin­i­cal test­ing in HS patients, and top-line data from this trial are antic­i­pated dur­ing the first half of 2019. In 2018, the Com­pany plans to ini­ti­ate addi­tional phase IIb clin­i­cal devel­op­ment of IFX‑1 in anti­neu­trophil cyto­plas­mic autoan­ti­bod­ies (ANCA)-associated vas­culi­tis (AAV) and in another autoim­mune or inflam­ma­tory indication.

2017 Cor­po­rate highlights

- In Sep­tem­ber 2017, the com­pany announced pos­i­tive topline data from an exploratory Phase IIa clin­i­cal trial with lead com­pound IFX‑1, a first-in-class anti-human com­ple­ment fac­tor C5a mon­o­clonal anti­body, in patients suf­fer­ing from mod­er­ate to severe Hidradeni­tis Sup­pu­ra­tiva (HS), a painful, chronic and debil­i­tat­ing inflam­ma­tory skin dis­ease. Assess­ment of the effi­cacy, mea­sured by the val­i­dated and clin­i­cally rel­e­vant Hidradeni­tis Sup­pu­ra­tiva Clin­i­cal Response (HiSCR) score, demon­strated a response rate of 75% (nine out of twelve patients) at the end of the treat­ment period and 83% (ten out of twelve) at the end of the twelve-week fol­low up period.

- In Octo­ber 2017, InflaRx suc­cess­fully closed a Series D financ­ing and invest­ment round of US$55 mil­lion. The round was co-led by Bain Cap­i­tal Life Sci­ences LP, Cor­morant Asset Man­age­ment LLC, RA Cap­i­tal Man­age­ment LLC, and com­ple­mented by Black Rock.

- In Novem­ber 2017, InflaRx raised US$106 mil­lion in its Nas­daq IPO (incl. green shoe). J.P. Mor­gan, Leerink Part­ners and BMO Cap­i­tal Mar­kets acted as lead managers.

- On Feb­ru­ary 6, 2018, InflaRx appointed Tony Gib­ney to its Board of Direc­tors. Mr. Gib­ney was a life sci­ences-focused invest­ment banker for 23 years at Leerink Part­ners, Mer­rill Lynch, and Lehman Brothers.

2017 Finan­cial highlights

Cash and cash equiv­a­lents totaled €123.3 mil­lion as of Decem­ber 31, 2017 com­pared to €29.1 mil­lion as of Decem­ber 31, 2016. This increase was pri­mar­ily attrib­ut­able to the com­ple­tion of InflaRx’ ini­tial pub­lic offer­ing of its com­mon shares in Novem­ber 2017 and the exer­cised green shoe in Decem­ber 2017, as well as the pri­mary por­tion of the Series D financ­ing exe­cuted in Octo­ber 2017.

Net cash used in oper­at­ing activ­i­ties increased from €5.0 mil­lion in the year ended Decem­ber 31, 2016 to €12.2 mil­lion in the year ended Decem­ber 31, 2017, mainly due to the increase of cash expenses for research and devel­op­ment, such as third-party expenses for man­u­fac­tur­ing and clin­i­cal tri­als attrib­ut­able to InflaRx’ lead pro­gram IFX‑1 and per­son­nel expenses.

Research and devel­op­ment expenses increased by €9.1 mil­lion to €14.4 mil­lion in the year ended Decem­ber 31, 2017 from € 5.3 mil­lion for the year ended Decem­ber 31, 2016. This increase is pri­mar­ily attrib­ut­able to a €5.1 mil­lion increase in CRO and CMO expenses for IFX‑1 in con­nec­tion with the prepa­ra­tion of the Phase IIb clin­i­cal trial in patients with HS and the Phase II clin­i­cal trial in patients with AAV and to a €3.4 mil­lion increase in employee-related costs asso­ci­ated with salaries, bonus, ben­e­fits and non-cash share-based compensation.

Gen­eral and admin­is­tra­tive expenses increased by €3.3 mil­lion to €5.1 mil­lion for the year ended Decem­ber 31, 2017, from €1.8 mil­lion for the year ended Decem­ber 31, 2016. This increase is pri­mar­ily attrib­ut­able to a €1.8 mil­lion increase in employee-related costs asso­ci­ated with salaries, bonus, ben­e­fits and non-cash share-based com­pen­sa­tion. Legal, con­sult­ing and audit fees and other expenses increased by €1.0 mil­lion, which is mainly attrib­ut­able to expenses incurred in con­nec­tion with the IPO and Nas­daq listing.

Finance costs (net) increased by €2.8 mil­lion to €4.8 mil­lion for the year ended Decem­ber 31, 2017, from €2.0 mil­lion for the year ended Decem­ber 31, 2016. This increase is mainly attrib­ut­able to inter­est expense on out­stand­ing pre­ferred shares issued in the Series C financ­ing, which increased by €0.4 mil­lion to €2.2 mil­lion for the year ended Decem­ber 31, 2017, from €1.8 mil­lion for the year ended Decem­ber 31, 2016; and unre­al­ized for­eign exchanges losses which increased by €2.4 mil­lion to €2.4 mil­lion for the year ended Decem­ber 31, 2017.

Net loss for the year 2017 was €24.2 mil­lion or €2.6 per com­mon share, com­pared to €8.9 mil­lion or €3.8 per com­mon share for the year 2016.

Addi­tional infor­ma­tion regard­ing these results is included in the notes to the con­sol­i­dated finan­cial state­ments as of Decem­ber 31, 2017 and “Item 5. Oper­at­ing and Finan­cial Review and Prospects,” which will be included in InflaRx’s Annual Report on Form 20‑F as filed with the SEC.

More infor­ma­tion and finan­cial reports: 2018_03_29_InflaRx_FYR2017