On March 21, 2018 Akari Therapeutics, Plc (NASDAQ:AKTX), a biopharmaceutical company focused on the development and commercialization of innovative therapeutics to treat orphan autoimmune and inflammatory diseases, reported its financial results for the fourth quarter and full year ended December 31, 2017 and highlights progress on its clinical development programs (Press release, Akari Therapeutics, MAR 21, 2018, View Source [SID1234524916]).

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"We made significant progress in 2017 advancing our lead product candidate, Coversin, across our clinical pipeline of orphan inflammatory diseases, most importantly in our Phase II trial for patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) which met its primary endpoint," commented Dr. David Horn Solomon, Chief Executive Officer of Akari Therapeutics. "With this Phase II trial now completed and the selection of the dosing regimen which is intended to be used in future clinical trials, we now look forward to the opening of the first clinical site by the end of March for our first Phase III trial of Coversin in patients with PNH using a convenient patient administered sub-cutaneous (SC) dosing."

"We believe Akari is well-positioned to move forward with its priority programs in 2018. In addition to PNH, we are focused on advancing Coversin into Phase II trials in the first half of 2018 in our other key disease targets involving both the complement and leukotriene pathways, the eye disease atopic keratoconjuntivitis (AKC) and the skin disorder bullous pemphigoid (BP), both of which are orphan indications with significant unmet need. We are also continuing our Phase II trial of Coversin in patients with aHUS, which commenced in late 2017. Additionally, we are advancing Coversin SC in a patient-convenient auto-injector pen device, and are advancing Coversin in topical eye-drops for AKC, and a long-acting formulation. Having ended 2017 with good momentum, 2018 is set to be an exciting year for the company as we work towards commercializing treatments for orphan autoimmune and inflammatory diseases."

Clinical Development Programs Highlights

Complement Program

Paroxysmal Nocturnal Hemoglobinuria (PNH)

Regulatory clearance recently received in Europe to open the first clinical trial site for CAPSTONE, the Phase III trial of Coversin in PNH patients who have not previously been treated with a complement inhibitor, in patient-convenient SC dosing.

Primary endpoint met in Phase II COBALT clinical trial of Coversin for patients with PNH who have never received a complement blocking therapy. The last three patients enrolled into the trial on the new dosing regimen of 45 mg per day saw a more rapid decline in LDH than those in the original dosing regimen.

The 45mg dosing regimen is the intended dose for the Phase III PNH trials of Coversin discussed with the U.S. Food and Drug Administration (FDA) in September 2017.

Seven of the eight enrolled patients in the Phase II COBALT trial completed the 90-day trial.1 These patients continue to be evaluated in a long-term safety study, CONSERVE, and have been receiving Coversin subcutaneously for between 5 to 14 months. To date there have been no drug-related serious adverse events reported and patients are self-administering.

§FDA granted Fast Track designation for Coversin for treatment of PNH in patients who have polymorphisms conferring eculizumab resistance.

Atypical Hemolytic Uremic Syndrome (aHUS)

A Phase II clinical trial for Coversin in aHUS was initiated in the fourth quarter of 2017.

Dual C5 and Leukotriene B4 Program

Atopic Keratoconjunctivitis (AKC) and Bullous Pemphigoid (BP)

The Company anticipates the start of two Phase II clinical trials, in the inflammatory-mediated eye disorder AKC and in the skin inflammatory disease BP, in the first half of 2018. In AKC, Coversin expected to be delivered in a topical eye drop formulation.

Fourth Quarter and Full Year 2017 Financial Results

§ Cash position: As of December 31, 2017, the Company had cash and cash equivalents of $28.1 million, as compared to cash, cash equivalents and short term investments of $44.1 million as of December 31, 2016.

§ Research and development (R&D) expenses: R&D expenses in the fourth quarter of 2017 were $7.1 million as compared to $6.6 million in the same quarter the prior year. R&D expenses for full year 2017 were $23.3 million, as compared to $17.3 million for the prior year. These increases were due primarily to expenses associated with the expanded clinical trial programs.

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§ General and administrative (G&A) expenses: G&A expenses in the fourth quarter of 2017 were $3.7 million, as compared to $3.3 million in the same quarter last year, and, for the full year 2017, $11.7 million as compared to $9.9 million in 2016. These increases were due primarily to higher legal, accounting and professional service fees, and increased personnel and recruiting expenses, offset by lower share-based compensation expense.

§ Net loss: Net loss for the fourth quarter of 2017 was $9.3 million compared to a net loss of $8.3 million for the same period in 2016. Net loss for full year 2017 was $32.6 million, compared to $18.1 million for full year 2016. These year over year increases in net loss were due primarily to higher R&D and G&A expenses.

Guidance

Based on its current cash position and operating plan, the Company expects that it has sufficient cash to fund operations into the second quarter of 2019. This estimate assumes no additional funding from new partnership agreements or debt or equity financing events.

1For the seven patients that completed the study, LDH as a multiple of ULN (xULN) was 1.4, 2.2, 2.3, 1.4, 1.3, 1.6 and 1.3 at day 28; 1.5, 2.1, 1.8, 1.5, 1.3, 1.4 and 2.2 at day 60; and 1.6, 2.4, 2.0, 1.9, 1.2, 1.5 and 2.5 at day 90.

Conference Call

Management will conduct a conference call at 8:30 a.m. ET today to review the Company’s fourth quarter and full year 2017 financial results. The call can be accessed by dialing (844) 461-9933 or (636) 812-6633 (international), and referencing conference ID 2096211. The conference call will also be webcast live over the Internet and can be accessed on the "Events & Presentations" page under the "Investors & Media" section of the Akari Therapeutics website, www.akaritx.com, prior to the event. A replay of the webcast will be available for at least 30 days following the call at www.akaritx.com.