On March 28, 2019 Forty Seven Inc. (NASDAQ:FTSV), a clinical-stage, immuno-oncology company focused on developing therapies to activate macrophages in the fight against cancer, reported financial results for the fourth quarter and full year ended December 31, 2018 and provided a business update (Press release, Forty Seven, MAR 28, 2019, View Source [SID1234534785]).

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"Our ultimate goal at Forty Seven is to enable more patients to defeat their cancers by delivering a new class of therapies, which take advantage of the innate immune system as a powerful therapeutic target," said Mark McCamish, M.D., Ph.D., President and Chief Executive Officer of Forty Seven, Inc. "In 2018, we made important strides toward achieving this goal, announcing proof-of-concept data for 5F9 in a range of difficult-to-treat cancers and demonstrating its best-in-class safety profile, which is enabled by our proprietary priming and maintenance dosing regimen. In addition, we expanded our pipeline with FSI-189 and FSI-174, reinforced our intellectual property portfolio, and strengthened our corporate position, hiring Ann Rhoads as Chief Financial Officer, adding Kristine Ball and Ian Clark to our Board of Directors, creating a world-class Scientific Advisory Board and successfully completing our initial public offering.

Dr. McCamish continued, "As we move into 2019, we are building on this forward momentum, with a particular focus on executing our clinical plans. We expect to generate meaningful data across multiple programs this year, beginning with updated clinical data from our Phase 1b/2 trial of 5F9 plus rituximab in r/r NHL and our Phase 1b trial of 5F9 as a monotherapy and in combination with azacitidine in AML and MDS, all expected in the second quarter. We are also advancing four additional trials with 5F9 and expect to provide updated data in ovarian and colorectal cancer in the fourth quarter, while conducting investigational new drug-application enabling studies for FSI-189, an anti-SIRPα antibody, and FSI-174, an anti-cKIT antibody."

Fourth Quarter and Recent Business Highlights:

Pipeline:

In January 2019, Forty Seven announced FSI-174, an anti-cKIT antibody, as its third development candidate. Forty Seven plans to develop FSI-174 in combination with anti-CD47 antibodies as a non-toxic transplant conditioning regimen, as well as a treatment for targeted hematologic malignancies.

In December 2018, Forty Seven presented preclinical data at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, providing additional mechanistic insight into why its proprietary 5F9 priming and maintenance dosing strategy mitigates the on-target anemia caused by the clearance of aged red blood cells (RBCs). The data show that the initial priming dose of 5F9 results in a near complete loss of CD47 on surviving, younger RBCs, making these cells less susceptible to phagocytosis and decreasing the risk of CD47 antibody-induced anemia during subsequent maintenance dosing.

O: 650-352-4150 F: 650-618-2308 W: fortyseveninc.com A: 1490 O’Brien Drive, Suite A, Menlo Park, CA 94025, United States

Helping Patients Defeat Their Cancer

Also at ASH (Free ASH Whitepaper), Forty Seven presented new preclinical data supporting the development of 5F9 and azacitidine for the treatment of AML. The data show that the combination of 5F9 and azacitidine increases the phagocytic elimination of AML blast cells by human macrophages in vitro, enhances clearance of AML in vivo, and prolongs survival compared to single-agent treatment with either 5F9 or azacitidine alone.

In November 2018, Forty Seven announced that proof-of-concept data from the Phase 1b portion of its Phase 1b/2 clinical trial evaluating 5F9 in combination with rituximab in patients with r/r NHL were published in the New England Journal of Medicine.

Key Upcoming Milestones:

The company expects to achieve the following milestones by the end of 2019:

Report data from the Phase 1b/2 trial of 5F9 in combination with rituximab in patients with r/r NHL, including safety, efficacy and duration of response across various dosing cohorts, in the second quarter.

Report data from the Phase 1b trial of 5F9 as a monotherapy and in combination with azacitidine in patients with AML and MDS, including safety and initial efficacy data, in the second quarter.

Report data from the Phase 1b trial of 5F9 in combination with avelumab in patients with ovarian cancer in the fourth quarter.

Report data from the Phase 1b trial of 5F9 in combination with cetuximab in patients with colorectal cancer in the fourth quarter.

Report preclinical data and complete IND-enabling studies for FSI-174 in the second half.

Completing IND-enabling studies for FSI-189 in the second half.

Fourth Quarter and Full Year 2018 Financial Results:

Cash Position: As of December 31, 2018, cash, cash equivalents and short-term investments were $139.0 million, as compared to $88.1 million as of December 31, 2017. This increase reflects net proceeds of $116.3 million from Forty Seven’s initial public offering of common stock, which closed in July 2018. The company expects that its cash, cash equivalents and short-term investments will fund operating expenses and capital expenditure requirements through the first half of 2020.

R&D Expenses: R&D expenses were $13.9 million for the fourth quarter of 2018 and $56.7 million for the full year ended December 31, 2018, as compared to $10.0 million for the fourth quarter of 2017 and $37.2 million for the full year ended December 31, 2017. This increase was primarily due to an increase in third party costs associated with the continued advancement of the company’s clinical development efforts, an increase in personnel-related costs, including stock-based compensation, and non-recurring upfront payments of $8.8 million associated with two licensing deals. This increase was partially offset by $5.3 million in grant funding and cost sharing from the California Institute of Regenerative Medicine, the Leukemia and Lymphoma Society, and Merck KGaA.

G&A Expenses: G&A expenses were $3.8 million for the fourth quarter of 2018 and $15.4 million for the full year ended December 31, 2018, as compared to $2.6 million for the fourth quarter of 2017 and $8.1 million for the full year ended December 31, 2017. This increase was primarily due to an increase in personnel-related costs and expenses incurred in connection with operating as a public company.

Net Loss: Net loss was $17.2 million for the fourth quarter of 2018 and $70.4 million for the full year ended December 31, 2018, or a net loss per share of $0.56 and $3.75, respectively, as compared to $12.3 million for the fourth quarter of 2017 and $44.9 million for the full year ended December 31, 2017, or a net loss per share of $1.88 and $6.94, respectively.

O: 650-352-4150 F: 650-618-2308 W: fortyseveninc.com A: 1490 O’Brien Drive, Suite A, Menlo Park, CA 94025, United States

Helping Patients Defeat Their Cancer

Conference Call Information:

Forty Seven will host a live conference call and webcast at 4:30 p.m. ET today to discuss fourth quarter and full year 2018 financial results and recent business activities. The conference call may be accessed by (866) 953-0780 (domestic) or (630) 652-5854 (international) and referring to conference ID 1089506. A webcast of the conference call will be available in the Investors section of the Forty Seven website at View Source The archived webcast will be available on Forty Seven’s website approximately two hours after the conference call and will be available for 30 days following the call.

On March 28, 2019 Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, reported the pricing of an underwritten public offering of 4,054,054 shares of its common stock at a public offering price of $74.00 per share, before underwriting discounts and commissions (Press release, Blueprint Medicines, MAR 28, 2019, View Source [SID1234534760]). In addition, Blueprint Medicines has granted the underwriters a 30-day option to purchase up to an additional 608,108 shares of its common stock at the public offering price, less underwriting discounts and commissions. All shares of common stock were offered by Blueprint Medicines.

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Goldman Sachs & Co. LLC and Cowen and Company, LLC are acting as joint book-running managers for the offering. Guggenheim Securities, LLC and Wedbush Securities Inc. are acting as co-lead managers for the offering. The offering is expected to close on or about April 2, 2019, subject to the satisfaction of customary closing conditions.

A registration statement on Form S-3 (File No. 333-216573) relating to these securities has been previously filed with the Securities and Exchange Commission (SEC) and has become effective. This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

The offering will be made only by means of a prospectus. A preliminary prospectus supplement describing the terms of the offering has been filed with the SEC and forms a part of the effective registration statement. A copy of the final prospectus supplement relating to the offering will be filed with the SEC and may be obtained, when available, from Goldman Sachs & Co. LLC by mail at Prospectus Department, 200 West Street, New York, NY 10282, by telephone at (866) 471-2526, by fax at (212) 902-9316, or by email at [email protected], or from Cowen and Company, LLC, c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, by telephone at (631) 274-2806, or by fax at (631) 254-7140.

On March 28, 2019 Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T cell product candidates, reported full year 2018 consolidated financial results prepared in accordance with IFRS (Press release, Celyad, MAR 28, 2019, View Source [SID1234534759]).

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Christian Homsy, CEO of Celyad: "In 2018, we identified several significant opportunities to drive long-term growth by focusing our clinical pipeline on the development of CAR-T cell product candidates. This includes the ongoing program for our lead product candidate CYAD-01 as well as our non-gene edited allogeneic candidate CYAD-101. Following encouraging preliminary data from the THINK trial evaluating CYAD-01 as a monotherapy for the treatment of relpased / refactory acute myeloid leukemia (r/r AML) patients, our clinical hematological program for CYAD-01 now includes multiple approaches for evaluating CYAD-01 including the THINK schedule optimization cohorts as well as our DEPLETHINK trial. We look forward to providing clinical updates from both the Phase 1 THINK and DEPLETHINK trials throughout 2019."

"In addition, we have advanced our shRNA platform to design novel preclinical CAR-T product candidates including our next-generation NKG2D-based CAR-T, CYAD-02, and our CYAD-200 series of non-gene edited allogeneic CAR-T candidates. We look forward to advancing multiple shRNA-based CAR-T product candidates towards the clinic in 2020."

Full Year 2018 and Recent Business Highlights

CYAD-01 – Autologous NKG2D-based CAR-T
Hematologic malignancies (r/rAML/MDS)

THINK Phase 1 trial, evaluating CYAD-01 without preconditioning chemotherapy, showed 40% (four out of ten) of patients with AML/MDS achieved a complete response.

Further development to assess a more frequent dosing schedule of CYAD-01 without preconditioning chemotherapy for the treatment of r/r AML is ongoing.

Cohort 1 of the DEPLETHINK Phase 1 trial, which is anopen-label, dose-escalation trial with a single injection of CYAD-01 following standard CyFlu preconditioning, demonstrated that CYAD-01 is well-tolerated, with no dose-limiting toxicity or treatment-related grade 3 or above adverse events (AEs) observed in patients with r/r AML.

Solid tumors (mCRC):

The concurrent treatment of CYAD-01 with FOLFOX chemotherapy in the first cohort of the trial was well tolerated, with no occurrence of serious AEs (SAEs) nor increase in the rate of treatment-related AEs. In addition, initial data from the THINK CyFlu cohort (single injection of CYAD-01 following treatment with CyFlu) showed that treatment is well tolerated with no occurrence of SAEs nor an increase in the treatment-related AEs rate. In addition, preliminary translational data suggest an improvement in the cell expansion of CYAD-01 induced by the CyFlu preconditioning.

CYAD-101 – Allogeneic NKG2D-based CAR-T
In 2018 the Company initiated the open-label, dose escalation alloSHRINK trial evaluating the non-gene edited allogeneic CAR-T therapy, CYAD-101, administered concurrently with FOLFOX chemotherapy in the treatment of patients with unresectable metastatic colorectal cancer (mCRC).

Novel, next-generation, shRNA platform
In March 2019, Celyad held a Research & Development Day in New York highlighting its pipeline of preclinical CAR-T product candidates candidates for the treatment of hematological malignancies and solid tumors, based on its short hairpin RNA (shRNA) platform

Autologous settings: CYAD-02 is a next-generation autologous NKG2D-based CAR-T candidate incorporating shRNA technology to target NKG2D ligands MICA/MICB. Preclinical AML models for CYAD-02 show an encouraging increase in in vitro proliferation and in vivo persistence and anti-tumor activity leading the company to plan to submit an Investigational New Drug (IND) application for CYAD-02 in the first half 2020.

Allogeneic settings: In vivo data demonstrate that shRNA targeting of CD3ζ by shRNA protects against graft-versus-host disease (GvHD) to a level equivalent to CRISPR-Cas9 based knock-out , as well as a significant increase in persistence of allogeneic T cells using shRNA targeting when compared to CRISPR-Cas9 gene-editing technologies.

This encouraged the company to develop three disruptive first-in-class non-gene-edited allogeneic CAR-T candidates from the CYAD-200 series leveraging the shRNA SMARTvector platform:

CYAD-211: B-cell maturation antigen (BCMA) targeting CAR-T therapy for the treatment of multiple myeloma, which is expected to enter the clinic by mid-2020
CYAD-221: CD19 targeting CAR-T therapy for the treatment of B-cell malignancies, which is expected to enter the clinic by late 2020
CYAD-231: Dual specific CAR-T targeting NKG2D and an undisclosed membrane protein, which is expected to enter the clinic by early 2021

Expected milestones for 2019

Additional data from the Phase 1 dose-escalation THINK trial for CYAD-01 in r/r AML or MDS patients, including initial data from the schedule optimization portion of the trial;
Enrollment completion and initial data from the Phase 1 dose-escalation DEPLETHINK trial evaluating CYAD-01 with preconditioning chemotherapy in r/r AML or MDS patients;
Acceleration of the development strategy and refinement of the regulatory pathway plan for CYAD-01 for the treatment of r/r AML or MDS patients, including the initiation of a potential Phase 2 clinical trial;
Advancement towards an IND application with the preclinical development of next-generation NKG2D-based CAR-T, CYAD-02 ; and
Further pursue the development of the proprietary non-gene edited allogeneic shRNA platform and progress towards IND applications for the CYAD-200 series of shRNA-based CAR-T candidates.

The Company’s license and collaboration agreements have generated a revenue of €3.1 million in 2018. This includes €2.4 million from the exclusive license agreement signed with Mesoblast Ltd. focused on the development and commercialization of Celyad’s intellectual property rights related to C-CathEZ, a proprietary intra-myocardial injection catheter, as well as €0.7 million from the non-clinical supply agreement with ONO Pharmaceutical Co., Ltd. with respect to the product candidate development of CYAD-101 for their licensed territories.

Research & Development expenses totaled €23.6 million and €22.9 million for 2018 and 2017, respectively. The increase in 2018 is mainly driven by the key clinical studies on CYAD-01 and CYAD-101.

General and Administrative expenses increased by €1.1 million, primarily driven by a non-cash expenses associated with the vesting of warrants.

The Company’s other expenses amount to €8.4 million and include non-cash expenses of €6.6 million relating to liability reassessment required by International Financial Reporting Standards (IFRS) related to the advancement in the Company’s NKG2D-based CAR-T candidates. Overall, non-cash expenses for 2018 totaled €10.2 million.

Therefore, Company’s operating loss of recurring operations (REBIT) increased to €38.2 million compared to €26.6 million for the year 2017. Net operational cash burn, which excludes non-cash effects, was €27.2 million in 2018 compared to €31.2 million in 2017.

Loss for the year 2018 amounts to €37.4 million versus a net loss of €56.4 million for 2017.

Cash, cash equivalents and short-term investments totaled €49.7 million as of December 31, 2018 compared to €33.9 million on December 31, 2017. The Company confirms its previous guidance that existing cash, cash equivalents and short-term investments should be sufficient to fund operating expenses and capital expenditure requirements, based on the current scope of activities, until mid-2020.

Annual Report 2018

The Annual Report for the year ended December 31, 2018 is published today, March 28, 2019, on the website of the Company. The statutory auditor, BDO Réviseurs d’Entreprises SCRL, has confirmed that the audit, which is substantially complete, has not to date revealed any material misstatement in the draft consolidated financial statements, and that the accounting data reported in the press release are consistent, in all material respects, with the draft consolidated financial statements from which it has been derived. On March 28, 2019, date of the release of the Annual Report, Celyad published a press release relating to the appointment of Mr. Filippo Petti as Chief Executive Officer of the Company effective on April 1, 2019. As a consequence of this publication, Celyad decided to issue a supplement to the Annual Report in order to keep the Annual Report up to the date of the convening notice to the 2019 annual shareholders’ meeting. This supplement will be published on the website of the Company within the next days.

Conference Call Details

A conference call will be held on Friday, 29 March 2019, at 1 p.m. CET / 8 a.m. EDT to review the financial and operating results for full year 2018. Please dial-in five to ten minutes prior to the call start time using the number and conference ID below: Standard International Dial-In Number: +44 (0) 2071 928000; Conference ID: 8745558

On March 28, 2019 Celyad (Euronext Brussels and Paris, and Nasdaq: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T therapies, reported the appointment of Filippo Petti as Chief Executive Officer (CEO) of Celyad effective April 1, 2019 (Press release, Celyad, MAR 28, 2019, View Source [SID1234534758]). Mr. Petti is currently Celyad’s Chief Financial Officer (CFO), and will serve as interim CFO until the Company appoints a permanent successor for the role. Dr. Homsy will continue to serve as a member of Celyad’s Board of Directors and chair the Strategy Committee of the Board of Directors. Dr. Homsy will support Mr. Petti in his new function on an as needed basis.

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Michel Lussier, Celyad’s Chairman commented:"The Board is delighted to appoint Filippo to the role given his intimate knowledge and appreciation for Celyad’s pipeline, team and shareholders as the Company advances its CAR-T therapies to the next stage of development. Since he joined the Company, Filippo has demonstrated that his experience combined with the vision of the Company should maximize value for all of our stakeholders including patients and shareholders."

"I am honored to succeed Christian as Celyad’s next CEO and together with the Board, the senior leadership team, and all of our employees, look forward to advancing our promising CAR-T programs to deliver novel therapies to cancer patients," said Mr. Petti."The momentum we are building across our pipeline is truly exciting and should provide the Company with a tremendous opportunity as we enter our next phase of growth."

Mr Lussier added: "Christian’s vision and drive, combined with his commitment to serving the long-term interests of the Company, has helped Celyad develop a growing pipeline of CAR-T candidates. Christian will continue to support an agile organization well-positioned for success. I’d like to thank him personally, and on behalf of the Board, for his tireless contribution to Celyad as CEO."

Dr. Homsy added: "I congratulate Filippo on his appointment and look forward to working with him in my new role. It has been an honor to lead the organization over the past 12 years making it a leader in cell therapy development and manufacturing. I am humbled by the talented people I have had the pleasure of working with since the inception of the Company. Today Celyad is an incredibly talented organization with exceptional vision and operational excellence. Together with the portfolio of groundbreaking technologies, this will undoubtedly make Celyad a forefront player of the CAR-T field. I am very grateful to Celyad employees and to all the other stakeholders for making this journey possible."

Mr. Petti has nearly 20 years of work experience related to the biopharmaceutical industry. Prior to joining Celyad as CFO, Mr. Petti served as a healthcare investment banker at Wells Fargo Securities and William Blair & Company. Prior to his roles in investment banking, he worked in equity research, with a focus in oncology, both at William Blair & Company and Wedbush Securities. Mr. Petti began his career as a research scientist at OSI Pharmaceuticals, Inc., where he was involved in translational research studies focused on the EGFR inhibitor Tarceva (erlotinib) before transitioning into corporate development with the company. Mr. Petti holds a Master of Business Administration from Cornell University, a Master of Science from St. John’s University and a Bachelor of Science from Syracuse University.

On March 28, 2019 InflaRx (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, reported financial results for the year ended December 31, 2018 (Press release, InflaRx, MAR 28, 2019, View Source [SID1234534756]).

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"2018 was marked by significant progress for InflaRx in both our business and clinical operations," said Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx. "Importantly, we completed enrollment of our Phase IIb trial with IFX-1 in Hidradenitis Suppurativa, from which we will report top-line results in the second quarter of 2019, and also initiated a Phase II trial in ANCA-associated vasculitis. We are continuing to execute our clinical development plans in 2019 as well, as evidenced by the recent initiation of our Phase IIa study in Pyoderma Gangraenosum."

Prof. Riedemann continued, "In addition to our pipeline progress, the Company experienced significant corporate growth in the past year by recruiting highly qualified directors to our board, opening our new R&D facility in the U.S. to support future innovation, and recruiting experienced executives to help us take InflaRx forward through 2019 and beyond. I am quite pleased with our team’s ability to execute on our core milestones of the past year and look forward to reporting on this continued progress in the months to come."

Corporate and drug development highlights – 2018 through early 2019

Corporate

Closed a primary and secondary offering in May 2018 for total gross proceeds of $117.3 million ($62.9 million to InflaRx and $54.4 million to selling shareholders), including the full exercise of the underwriters’ option to purchase additional shares.

Appointed highly experienced executives to the Board of Directors: Tony Gibney, CBO of Achillion Pharmaceuticals, Inc. and Jens Holstein, CFO of MorphoSys AG. Richard Brudnick, CBO of Codiak BioSciences, appointed as Non-Executive Director, subject to shareholder approval at our annual general meeting (currently serving as a Non-Voting Observer).

Expanded U.S. operations with opening of two U.S. sites – R&D facility in Ann Arbor, Michigan and corporate offices in New York City.

Hired senior executives for key positions – Jason Marks (formerly of Bausch Health) as Chief Legal Officer/General Counsel and Jordan Silverstein (formerly of Advanced Accelerator Applications) as Head of Corporate Strategy/Development.

Expanding research and development activities supported by growth in number of employees to 38 as of December 31, 2018 (2017: 21).

Lead product candidate, IFX-1, first-in-class anti-human complement factor C5a antibody

Hidradenitis Suppurativa (HS)

First patient enrolled in March 2018 in Phase IIb SHINE trial in moderate or severe HS and enrollment completed in November 2018. The randomized, double-blind, placebo-controlled, multicenter study is being conducted at 38 sites in North America and Europe. Topline results are expected in the second quarter of 2019.

New long-term retrospective data from completed Phase IIa trial presented in February 2019 at the 8th Conference of the European Hidradenitis Suppurativa Foundation. The data showed sustained remissions and median time to first flare of almost seven months, after only eight weeks of treatment.

ANCA-associated vasculitis (AAV).

Received FDA clearance of an IND application for U.S. Phase II study in patients with AAV in June 2018 and dosed the first patient in October 2018. The randomized, double-blind, placebo-controlled Phase II study is planned to enroll approximately 36 patients at approximately 20 sites in the U.S.

Investigational Medicinal Product Dossier (IMPD) approved in December 2018 by European regulatory authorities, to initiate a Phase II study in Europe in patients with AAV. The randomized, double-blind, placebo-controlled study is planned to enroll approximately 80 patients at about 60 sites in Europe.

2018 financial highlights

Cash and cash equivalents plus securities and other investments. As of December 31, 2018, InflaRx had cash and cash equivalents and securities and other investments of €156.6 million, compared to €123.3 million at the end of 2017. This increase in funds of approximately €33.3 million was primarily attributable to the completion of InflaRx’s follow-on offering of common shares in May 2018. Cash and cash equivalents totaled €55.4 million as of December 31, 2018 (December 31, 2017: €123.3 million). Additionally, current financial assets totaled €101.2 million compared to €0 as of December 31, 2017.

Net cash used in operating activities increased to €23.7 million in 2018, from €12.2 million in 2017, mainly due to higher 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 €10.6 million to €25.0 million in 2018, compared to €14.4 million in 2017. This increase is primarily attributable to a €7.1 million increase in CRO and CMO expenses for IFX-1 in connection with preparation to commence the clinical trial Phase IIb in patients with HS and the Phase II clinical program in patients with AAV, as well as with the ongoing manufacturing activities for clinical trial material for these clinical trials with IFRX-1 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 amounted to €12.8 million in 2018, an increase of €7.7 million from €5.1 million in 2017. This was primarily attributable to a €6.2 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 €0.5 million, which is mainly attributable to expenses incurred in connection with the follow on offering of common shares in May 2018.

Net financial result was €7.7 million, up by €12.5 million compared to a net financial loss of €4.8 million in 2017, mainly due to net foreign exchange gains. Large portions of InflaRx’ funds are held in U.S. dollars and the dollar improved compared to the euro during 2018.

Loss for the period 2018 was €29.8 million or €1.2 per common share (basic and diluted), compared to €24.2 million or €2.6 per common share (basic and diluted) for 2017.

Additional information regarding these results is included in the notes to the consolidated financial statements as of and for the year ended December 31, 2018 and "ITEM 18. Financial statements", which will be included in InflaRx’ Annual Report on Form 20-F as filed with the SEC.

About IFX-1:

IFX-1 is a first-in-class monoclonal anti-human complement factor C5a antibody, which highly and effectively blocks the biological activity of C5a and demonstrates high selectivity towards its target in human blood. Thus, IFX-1 leaves the formation of the membrane attack complex (C5b-9) intact as an important defense mechanism, which is not the case for molecules blocking the cleavage of C5. IFX-1 has been demonstrated to control the inflammatory response driven tissue and organ damage by specifically blocking C5a as a key "amplifier" of this response in pre-clinical studies. IFX-1 is believed to be the first monoclonal anti-C5a antibody introduced into clinical development and has, to date, successfully completed three clinical Phase II studies. More than 150 people have been treated with IFX-1 in these completed clinical trials, and the antibody has been shown to be well tolerated. IFX-1 is currently being developed for various inflammatory indications, including Hidradenitis Suppurativa and ANCA-associated vasculitis.