On November 4, 2019 Akari Therapeutics, Plc (Nasdaq: AKTX), a biopharmaceutical company focused on innovative therapeutics to treat orphan autoimmune and inflammatory diseases where complement (C5) and/or leukotriene (LTB4) systems are implicated, reported financial results for the third quarter ended September 30, 2019 and recent clinical progress (Press release, Akari Therapeutics, NOV 4, 2019, View Source [SID1234550590]).
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"We are excited about the positive clinical data we are accumulating in patients treated with nomacopan across our target rare disease indications. The rapid and sustained clinical clinical improvement combined with the positive long-term safety profile we have observed in patients, helps to offer further validation of nomacopan’s unique method of action as an inhibitor of both the complement and leukotriene pathways," said Clive Richardson, Chief Executive Officer of Akari Therapeutics. "We look forward to further progress across both our topical and subcutaneous clinical programs in 2020 as we look to drive nomacopan through the clinic and towards helping patients afflicted by these rare and debilitating inflammatory conditions. In addition, we seek to partner those programs in which a joint development approach can produce a faster outcome."
Third Quarter 2019 and Recent Business Highlights
Akari’s strategy is to focus on orphan inflammatory diseases with significant unmet medical need, where the role of the complement and leukotriene systems are implicated. Akari’s lead programs are in BP, AKC, and HSCT-TMA where clinical data with nomacopan has shown rapid and sustained clinical improvement in patients. These diseases have no approved treatments.
Further evidence for potential therapeutic benefits of inhibition of C5 and LTB4 by nomacopan
In the last three months, the Company has announced preclinical data in both BP and AKC demonstrating the likely combined role of C5 and LTB4 in these two severe inflammatory conditions:
In BP, an orphan condition with no approved treatment, the Company announced new data demonstrating synergistic benefits of nomacopan’s dual C5 and LTB4 inhibitory activity. This new study was undertaken by Dr. Christian Sadik’s team at University of Lubeck, Germany. These data were published in the August 2019 edition of JCI Insight [link].
In AKC, a surface of the eye disease with no approved treatment, the Company announced new data from the conjunctival tissue of patients showing for the first time the presence of both the C5a receptor and the leukotriene LTB4 receptor on the conjunctival surface of the eye.
Pediatric HSCT-TMA
A pivotal trial for HSCT-TMA with nomacopan is expected to start in the fourth quarter of 2019. This devastating condition has an estimated 80% mortality rate in children and has no approved treatments. In August 2019, the FDA granted Fast Track designation to nomacopan for the treatment of HSCT-TMA as well as orphan drug designation for treatment of pediatric patients.
Phase II clinical trial in patients with BP
Phase II trial results with nomacopan were presented at the 28th European Academy of Dermatology and Venereology (EADV) Congress on October 10, 2019. Four of the six patients were classified as at the upper limit of moderate BP. The four patients saw a rapid and significant improvement in symptoms, with a mean 63% decline in Bullous Pemphigoid Disease Area Index (BPDAI) score and mean 68% decline in blister score by day 42, with either no or minimal early steroid treatment. The data showed nomacopan’s potential as monotherapy with the additional potential benefit of reducing steroid use which has multiple adverse effects.
During the third quarter of 2019, the FDA granted orphan drug designation for nomacopan for the treatment of BP. The company is now exploring pivotal trial designs.
Phase I/II clinical trial in patients with AKC
Successfully completed Part A of the Phase I/II clinical trial in severe AKC patients who showed a rapid overall improvement of a mean 55% in the composite clinical score. The nomacopan eye drops were found to be comfortable and well tolerated with no reported drug related serious adverse events. Enrollment in the Part B placebo-controlled efficacy arm of the study in 16 patients continues, with a data read out expected in the first quarter of 2020.
Paroxysmal nocturnal hemoglobinuria (PNH) program
The Company continues to accumulate positive long-term treatment data, which includes over 20 cumulative patient-years of data with no reported drug related serious adverse events. Our ongoing Phase III PNH study in naïve patients is expected to have an interim data readout in mid 2020 with the next stage subject to our pen injector program which aims to hold one week’s supply of nomacopan stable at room temperature with a daily 0.3ml injection.
Third Quarter 2019 Financial Results
As of September 30, 2019, the Company had cash of $6.3 million. In addition, the Company received in October 2019 $2.9 million in research and development tax credits from the UK tax authorities. This compares to cash of $5.4 million as of December 31, 2018.
During the third quarter of 2019, the Company sold to Aspire Capital Fund, LLC (Aspire Capital) a total of $4.6 million of ordinary shares. As of September 30, 2019, approximately $13.4 million of the original $20 million remains available for draw down under the equity purchase agreement entered into with Aspire Capital.
Research and development (R&D) expenses in the third quarter of 2019 were $1.8 million, as compared to R&D expenses of $3.3 million in the same quarter the prior year. This decrease was primarily due to the recognition of the aforementioned R&D tax credit of $2.9 million in the third quarter of 2019, proceeds of which were received in October 2019.
General and administrative (G&A) expenses in the third quarter of 2019 were $1.4 million, as compared to $2.4 million in the same quarter last year. This decrease was primarily due to lower expenses associated with professional fees and rent.
Total other income for the third quarter of 2019 was $0.4 million, as compared to total other expense of $0.6 million in the same period the prior year. This change was primarily due to $1.0 million of higher income related to the change in the fair value of the stock option liabilities in 2019 compared to 2018.
Net loss for the third quarter of 2019 was $2.8 million, compared to a net loss of $3.6 million for the same period in 2018. The decrease in net loss in the third quarter of 2019 was due primarily to lower net R&D and G&A expenses, as well as change in the fair value of the stock option liabilities previously cited, offset by the one-time litigation settlement gain that was recorded in the third quarter of 2018.