Akari Therapeutics Reports Third Quarter 2019 Financial Results And Highlights Recent Clinical Progress
- New data demonstrate dual role of C5 and LTB4 in both bullous pemphigoid (BP) and atopic keratoconjunctivitis (AKC). There are no
- Clinical progress across our target conditions
- Phase II BP data demonstrated a rapid and significant improvement in symptoms with a mean 63% decline in BPDAI score and mean 68% decline in blister score by day 42 in patients with moderate BP
- Part A of AKC Phase I/II study completed with a rapid mean 55% improvement in the composite clinical score at day 56
- Continued advancement of clinical programs
- Pivotal clinical trial for pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA) expected to start Q4 2019
- Fast Track designation for HSCT-TMA and orphan drug designation for BP and HSCT-TMA granted by the
- Over 20 cumulative patient-years of nomacopan treatment data with no reported drug related serious adverse events in any patients treated to date across the four conditions
“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
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’steam at University of Lubeck, Germany. These data were published in the August 2019edition 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.
- 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 FDAgranted 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) Congresson 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
FDAgranted 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 millionin research and development tax credits from the UKtax authorities. This compares to cash of $5.4 millionas 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 millionof ordinary shares. As of September 30, 2019, approximately $13.4 millionof the original $20 millionremains 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 millionin the same quarter the prior year. This decrease was primarily due to the recognition of the aforementioned R&D tax credit of $2.9 millionin 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 millionin 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 millionin the same period the prior year. This change was primarily due to $1.0 millionof 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 millionfor 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.
Akari is a biopharmaceutical company focused on developing inhibitors of acute and chronic inflammation, specifically for the treatment of rare and orphan diseases, in particular those where the complement (C5) or leukotriene (LTB4) systems, or both complement and leukotrienes together, play a primary role in disease progression. Akari's lead drug candidate, nomacopan (formerly known as Coversin), is a C5 complement inhibitor that also independently and specifically inhibits leukotriene B4 (LTB4) activity. Nomacopan is currently being clinically evaluated in four indications: bullous pemphigoid (BP), atopic keratoconjunctivitis (AKC), thrombotic microangiopathy (TMA), and paroxysmal nocturnal hemoglobinuria (PNH). Akari believes that the dual action of nomacopan on both C5 and LTB4 may be beneficial in AKC and BP. Akari is also developing other tick derived proteins, including longer acting versions.
Cautionary Note Regarding Forward-Looking Statements
Certain statements in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements related to the offering, the expected gross proceeds and the expected closing of the offering. These forward-looking statements reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control. Such risks and uncertainties for our company include, but are not limited to: needs for additional capital to fund our operations, our ability to continue as a going concern; uncertainties of cash flows and inability to meet working capital needs; an inability or delay in obtaining required regulatory approvals for nomacopan and any other product candidates, which may result in unexpected cost expenditures; our ability to obtain orphan drug designation in additional indications; risks inherent in drug development in general; uncertainties in obtaining successful clinical results for nomacopan and any other product candidates and unexpected costs that may result therefrom; our ability to enter into collaborative, licensing, and other commercial relationships and on terms commercially reasonable to us; difficulties enrolling patients in our clinical trials; failure to realize any value of nomacopan and any other product candidates developed and being developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; inability to develop new product candidates and support existing product candidates; the approval by the
|AKARI THERAPEUTICS, Plc|
|CONDENSED CONSOLIDATED BALANCE SHEETS
As of September 30, 2019 and December 31, 2018
(in U.S. Dollars, except share data)
|Tax Credit Receivable||2,902,987||-|
|Prepaid expenses and other current assets||1,058,527||1,423,184|
|Deferred financing costs||402,042||585,000|
|Total Current Assets||10,632,223||7,454,322|
|Property and equipment, net||8,388||20,425|
|Patent acquisition costs, net||29,147||32,978|
|Liabilities and Shareholders' Equity|
|Liability related to options||2,053,966||1,842,424|
|Share capital of £0.01 par value|
|Authorized: 10,000,000,000 ordinary shares; issued and outstanding: 2,100,865,913 and 1,580,693,413 at September 30, 2019 and December 31, 2018, respectively||30,123,701||23,651,277|
|Additional paid-in capital||110,774,033||106,616,083|
|Accumulated other comprehensive loss||(402,094||)||(352,426||)|
|Total Shareholders' Equity||4,265,325||3,111,287|
|Total Liabilities and Shareholders' Equity||$||10,669,758||$||8,029,554|
|AKARI THERAPEUTICS, Plc|
|CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - UNAUDITED
For the Three and Nine Months Ended September 30, 2019 and September 30, 2018
(in U.S. Dollars)
|Three Months Ended||Nine Months Ended|
|September 30, 2019||September 30, 2018||September 30, 2019||September 30, 2018|
|Research and development expenses||$||1,763,057||$||3,303,790||$||3,038,038||$||9,433,018|
|General and administrative expenses||1,354,263||2,382,153||6,098,767||8,537,191|
|Litigation settlement gain||-||(2,700,000||)||-||(2,700,000||)|
|Total Operating Expenses||3,117,320||2,985,943||9,136,805||15,270,209|
|Loss from Operations||(3,117,320||)||(2,985,943||)||(9,136,805||)||(15,270,209||)|
|Other Income (Expenses):|
|Changes in fair value of option liabilities – gain/(loss)||316,541||(715,846||)||(211,542||)||2,077,128|
|Foreign currency exchange gains (losses)||37,209||36,036||(71,989||)||42,481|
|Total Other Income (Expenses)||353,019||(607,312||)||(289,863||)||2,316,183|
|Other Comprehensive (Loss) Income:|
|Foreign Currency Translation Adjustment||3,280||(65,848||)||(49,668||)||(60,237||)|
|Loss per ordinary share (basic and diluted)||$||(0.00||)||$||(0.00||)||$||(0.01||)||$||(0.01||)|
|Weighted average ordinary shares outstanding (basic and diluted)||1,971,025,222||1,528,682,540||1,721,098,272||1,526,700,724|
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Source: Akari Therapeutics Plc