Akari Announces First Quarter 2018 Financial Results and Update on its Growing Pipeline of Phase II and Phase III Clinical Trials
- Opened three clinical trials in 2018
- Trials in which complement dysregulation is the primary disease driver
- CAPSTONE, the Phase III trial in naïve paroxysmal nocturnal hemoglobinuria (PNH), in which patient treatment has commenced
- Phase II U.S. trial for PNH patients resistant to treatment with Soliris where a patient is now being treated
- Phase II trial in atypical haemolytic syndrome (aHUS) which opened Q4 2017
- Trials focused on a separate group of diseases mediated by both the complement and leukotriene pathways
- Phase II trial in bullous pemphigoid (BP), recently opened with data expected Q1 2019
- Phase I/II trial in atopic keratoconjunctivitis (AKC) expected to commence Q3 2018, with data anticipated Q1 2019
“We are excited by the range of clinical opportunities that we are currently exploring. We look forward to providing initial clinical data from these trials starting in the fourth quarter of 2018,” commented
Clinical Development Programs Highlights
Akari’s clinical program is divided into two separate workstreams targeting two different sets of clinical conditions. One group of diseases is where the combined inhibition of the complement and leukotriene pathways provides a potential new treatment solution for a wide range of currently poorly treated orphan inflammatory conditions. The second group of diseases are those where complement dysregulation is the primary driver.
Dual C5 and Leukotriene B4 Program
The increasing recognition that LTB4 may combine with complement dysregulation in the etiology of many autoimmune and autoinflammatory conditions has focused Akari’s clinical development on a number of poorly treated conditions where Coversin’s dual C5 and LTB4 binding provides a potential novel therapeutic solution. These programs include bullous pemphigoid (BP), an inflammatory skin disease in which current treatment is limited to steroids, and immunosuppressants and atopic keratoconjunctivitis (AKC), an eye surface inflammatory disease which can lead to permanent vision loss and for which there are few effective treatment options. Both are rare conditions for which Akari is seeking orphan designation.
Patient treatment in CAPSTONE, the Phase III trial in naïve PNH patients, has commenced. We anticipate introducing a new pen injector in 2019 to facilitate patient use which will accommodate a week’s supply of medication. Within the program to treat patients with a polymorphism that makes them resistant to treatment with Soliris, Akari recently began treating a second PNH patient under an investigational new drug application (IND) in the U.S. This patient has responded well (LDH <1.5xULN at day 28). In all, three Soliris resistant patients have now been treated with Coversin; two with PNH and a third with a thrombotic microangiopathy (TMA). All PNH patients remaining on treatment have the option of entering into the Akari long term safety program. Nine PNH patients have been treated in aggregate for over 11 patient years with no drug related SAEs to date.
Akari has also opened a clinical program targeting thrombotic microangiopathies (TMA) including atypical haemolytic syndrome (aHUS). We expect to provide an update on Akari’s TMA program in Q4 2018.
First Quarter 2018 Financial Results
- As of
March 31, 2018, the Company had cash of $23.8 million, as compared to cash of $28.1 millionas of December 31, 2017.
- Operating expenses, which include research and development (R&D) expenses and general and administrative (G&A) expenses, were
$4.3 millionin the first quarter of 2018, as compared to $8.3 millionin the same quarter the prior year.
- R&D expenses in the first quarter of 2018 were
$1.0 million, as compared to $6.0 millionin the same quarter the prior year. The decrease was due primarily to an R&D tax credit of approximately $3.8 millionreceived in the first quarter of 2018 and lower manufacturing costs of $1.4 millionassociated with Coversin clinical trial material, offset by an increase in clinical trial expenses.
- G&A expenses in the first quarter of 2018 were
$3.3 million, as compared to $2.3 millionin the same quarter last year. This increase was due primarily to higher legal, accounting and other professional service fees.
- R&D expenses in the first quarter of 2018 were
- Total other income for the first quarter of 2018 was
$3.0 million, as compared to total other expense of $4.3 millionin the first quarter of 2017. This change was primarily attributed to $2.9 millionof other income in the first quarter of 2018 compared to $4.3 millionof other expense in the same period in 2017 related in both instances to the change in fair value of the stock option and warrant liabilities.
- Net loss for the first quarter of 2018 was
$1.3 million, compared to a net loss of $12.6 millionfor the same period in 2017. This year over year decrease in net loss was due primarily to lower R&D expenses in the first quarter of 2018 when compared to the same period in 2017.
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 system or leukotrienes or both complement and leukotrienes together play a primary role in disease progression. Akari's lead drug candidate Coversin™ is a C5 complement inhibitor currently being evaluated in paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). In addition to its C5 inhibitory activity, Coversin independently and specifically inhibits leukotriene B4 (LTB4) activity. Akari is currently evaluating Coversin in two conditions, the skin and eye diseases bullous pemphigoid and atopic keratoconjunctivitis, where the dual action of Coversin on both C5 and LTB4 may be beneficial. Akari is also developing other tick derived proteins, including long 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. 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 Coversin 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 Coversin and any other product candidates and unexpected costs that may result therefrom; difficulties enrolling patients in our clinical trials; failure to realize any value of Coversin 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 March 31, 2018 and December 31, 2017|
|(in U.S. Dollars, except share data)|
|March 31, 2018||December 31, 2017|
|Prepaid expenses and other current assets||$||1,484,864||$||706,415|
|Total Current Assets||$||25,266,305||28,813,086|
|Property and equipment, net||$||47,345||$||55,898|
|Patent acquisition costs, net||$||39,638||$||39,124|
|Liabilities and Shareholders' Equity|
|Liability related to options||$||2,135,804||$||5,081,335|
|Total Current Liabilities||$||9,077,063||11,848,369|
|Other long-term liability||$||94,325||$||48,003|
|Commitments and Contingencies|
|Share capital GBP of .01 par value|
|Authorized: 10,000,000,000 ordinary shares; issued and outstanding:|
|1,525,693,393 at March 31, 2018 and December 31, 2017, respectively||22,927,534||$||22,927,534|
|Additional paid-in capital||105,275,508||$||104,799,550|
|Accumulated other comprehensive loss||(203,447||)||$||(236,246||)|
|Total Shareholders' Equity||16,324,153||17,153,971|
|Total Liabilities and Shareholders' Equity||25,495,541||$||29,050,343|
|AKARI THERAPEUTICS, Plc|
|CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS-UNAUDITED|
|For the Three Months Ended March 31, 2018 and 2017|
|(in U.S. Dollars)|
|Three Months Ended|
|Mar 31, 2018||Mar 31, 2017|
|Research and development costs||$||1,008,388||$||6,002,700|
|General and administrative expenses||3,296,973||$||2,280,489|
|Total Operating Expenses||4,305,361||8,283,189|
|Loss from Operations||(4,305,361||)||(8,283,189||)|
|Other Income (Expense):|
|Changes in fair value of option and warrant liabilities - gain (loss)||2,945,531||$||(4,331,741||)|
|Foreign currency exchange loss||(40,975||)||$||(6,759||)|
|Total Other Income (Expense)||2,966,785||(4,301,323||)|
|Other Comprehensive Income (Loss):|
|Foreign Currency Translation Adjustment||32,799||$||(45,153||)|
|Loss per common share (basic and diluted)||$||(0.00||)||$||(0.01||)|
|Weighted average common shares (basic and diluted)||1,525,693,393||1,177,693,383|
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Source: Akari Therapeutics Plc