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Name | Symbol | Market | Type |
---|---|---|---|
Akari Therapeutics PLC | NASDAQ:AKTX | NASDAQ | Depository Receipt |
Price Change | % Change | Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
-0.23 | -13.53% | 1.47 | 1.32 | 3.59 | 1.8676 | 1.4283 | 1.69 | 38,277 | 21:25:00 |
“We remain focused on our mission of addressing severe inflammatory diseases with significant unmet medical need. We are pleased that our company is now in the process of planning or undertaking pivotal trials in both BP and HSCT-TMA as well as progressing next clinical steps for studies in atopic keratoconjunctivitis (AKC) and COVID-19 pneumonia,” said Clive Richardson, Chief Executive Officer of Akari Therapeutics.
Severe inflammatory diseases remain an area of high unmet need. Akari continues to make progress driving its anti-inflammatory programs forward, including the recent announcement of positive topline results from our Phase II BP study in May.
First Quarter 2020 and Recent Clinical Highlights
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.
As previously disclosed, the Company is following regulatory and health agency guidance related to the COVID-19 pandemic to help ensure the safety of its employees and patients. The impact on individual studies is detailed below.
Phase II clinical trial in patients with BP
Phase III clinical trial in pediatric patients with HSCT-TMA
Phase I/II clinical trial in patients with AKC
Patients with COVID-19 pneumonia
First Quarter 2020 Financial Results
Important Message Regarding COVID-19
Akari’s clinical trial sites are based in areas currently affected by coronavirus. Epidemics such as this can adversely impact the business as a result of disruptions, such as travel bans, quarantines, and interruptions to access the trial sites and supply chain, which could result in material delays and complications with respect to research and development programs and clinical trials. Moreover, as a result of coronavirus, there is a general unease of conducting unnecessary activities in medical centers. As a consequence, ongoing trials have been halted or disrupted. It is too early to assess the full impact of the coronavirus outbreak on trials for nomacopan, but coronavirus is expected to affect Akari’s ability to complete recruitment in the original timeframe. The extent to which the coronavirus impacts operations will depend on future developments, which are highly uncertain and cannot be predicted with confidence, including the duration and severity of the outbreak, and the actions that may be required to contain the coronavirus or treat its impact. In particular, the continued spread of the coronavirus globally, could adversely impact Akari’s operations and workforce, including research and clinical trials and the Company’s ability to raise capital, could affect the operations of key governmental agencies, such as the FDA, which may delay the development of our product candidates and could result in the inability of our suppliers to deliver components or raw materials on a timely basis or at all, each of which in turn could have an adverse impact on the business, financial condition and results of operation.
About Akari Therapeutics
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 FDA and EMA and any other similar foreign regulatory authorities of other competing or superior products brought to market; risks resulting from unforeseen side effects; risk that the market for nomacopan may not be as large as expected; risks associated with the impact of the outbreak of coronavirus; risks associated with the SEC investigation; inability to obtain, maintain and enforce patents and other intellectual property rights or the unexpected costs associated with such enforcement or litigation; inability to obtain and maintain commercial manufacturing arrangements with third party manufacturers or establish commercial scale manufacturing capabilities; the inability to timely source adequate supply of our active pharmaceutical ingredients from third party manufacturers on whom the company depends; unexpected cost increases and pricing pressures and risks and other risk factors detailed in our public filings with the U.S. Securities and Exchange Commission, including our most recently filed Annual Report on Form 20-F filed with the SEC. Except as otherwise noted, these forward-looking statements speak only as of the date of this press release and we undertake no obligation to update or revise any of these statements to reflect events or circumstances occurring after this press release. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release.
AKARI THERAPEUTICS, Plc
CONDENSED CONSOLIDATED BALANCE SHEETSAs of March 31, 2020 and December 31, 2019 (in U.S. Dollars, except share data)
March 31, 2020 | December 31, 2019 | |||||||
(Unaudited) | ||||||||
Assets | ||||||||
Current Assets: | ||||||||
Cash | $ | 7,822,180 | $ | 5,731,691 | ||||
Prepaid expenses and other current assets | 1,828,444 | 712,975 | ||||||
Deferred financing costs | 288,705 | 321,956 | ||||||
Total Current Assets | 9,939,329 | 6,766,622 | ||||||
Property and equipment, net | 2,096 | 5,013 | ||||||
Patent acquisition costs, net | 27,566 | 30,163 | ||||||
Total Assets | $ | 9,968,991 | $ | 6,801,798 | ||||
Liabilities and Shareholders' Equity (Deficit) | ||||||||
Current Liabilities: | ||||||||
Accounts payable | $ | 966,059 | $ | 1,228,772 | ||||
Accrued expenses | 2,630,857 | 4,228,604 | ||||||
Liabilities related to options and warrants | 4,556,448 | 3,116,880 | ||||||
Total Liabilities | 8,153,364 | 8,574,256 | ||||||
Commitments and Contingencies | ||||||||
Shareholders' Equity (Deficit): | ||||||||
Share capital of £0.01 par value | ||||||||
Authorized: 10,000,000,000 ordinary shares; issued and outstanding: 2,872,895,513 and 2,245,865,913 at March 31, 2020 and December 31, 2019, respectively | 40,085,648 | 31,987,016 | ||||||
Additional paid-in capital | 109,596,064 | 110,498,824 | ||||||
Accumulated other comprehensive loss | (571,585 | ) | (348,860 | ) | ||||
Accumulated deficit | (147,294,500 | ) | (143,909,438 | ) | ||||
Total Shareholders' Equity (Deficit) | 1,815,627 | (1,772,458 | ) | |||||
Total Liabilities and Shareholders' Equity (Deficit) | $ | 9,968,991 | $ | 6,801,798 |
AKARI THERAPEUTICS, Plc
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - UNAUDITEDFor the Three Months Ended March 31, 2020 and 2019(in U.S. Dollars)
Three Months Ended | ||||||||
March 31, 2020 | March 31, 2019 | |||||||
Operating Expenses: | ||||||||
Research and development expenses (income) | $ | 2,732,165 | $ | (2,318,360 | ) | |||
General and administrative expenses | 2,194,809 | 2,306,398 | ||||||
Total Operating Expenses (Income) | 4,926,974 | (11,962 | ) | |||||
Income (Loss) from Operations | (4,926,974 | ) | 11,962 | |||||
Other Income (Expenses): | ||||||||
Interest income | 1,010 | 1,286 | ||||||
Changes in fair value of option and warrant liabilities – gain/(loss) | 1,309,801 | (2,358,772 | ) | |||||
Foreign currency exchange gains (losses) | 233,404 | (195,635 | ) | |||||
Other expenses | (2,303 | ) | (4,124 | ) | ||||
Total Other Income (Expenses) | 1,541,912 | (2,557,245 | ) | |||||
Net Loss | (3,385,062 | ) | (2,545,283 | ) | ||||
Other Comprehensive (Loss) Income: | ||||||||
Foreign Currency Translation Adjustment | (222,725 | ) | 107,168 | |||||
Comprehensive Loss | $ | (3,607,787 | ) | $ | (2,438,115 | ) | ||
Loss per ordinary share (basic and diluted) | $ | (0.00 | ) | $ | (0.00 | ) | ||
Weighted average ordinary shares outstanding (basic and diluted) | 2,516,280,709 | 1,580,860,080 |
For more informationInvestor Contact:
Peter VozzoWestwicke(443) 213-0505peter.vozzo@westwicke.com
Media Contact:
Sukaina Virji / Lizzie SeeleyConsilium Strategic Communications+44 (0)20 3709 5700Akari@consilium-comms.com
1 Year Akari Therapeutics Chart |
1 Month Akari Therapeutics Chart |
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