NEW YORK and LONDON, Sept. 01, 2020 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biopharmaceutical company focused on innovative therapeutics to treat orphan autoimmune and inflammatory diseases where complement (C5) and/or leukotriene (LTB4) systems are implicated, today announced financial results for the second quarter ended June 30, 2020, as well as recent clinical progress.
“Akari continues to make good clinical progress, and since the beginning of the year has successfully completed its Phase II BP program and now has a clear pathway towards U.S. regulatory approval from the FDA. The HSCT-TMA program is set to commence recruitment in the fourth quarter of 2020 and we have initiated a COVID-19 pneumonia clinical program across multiple countries that leverages the unique dual C5 and LTB4 inhibition of nomacopan,” said Clive Richardson, Chief Executive Officer of Akari Therapeutics.
Second Quarter 2020 and Recent Clinical Highlights
Akari’s lead programs are in BP, HSCT-TMA, COVID-19 pneumonia and AKC. These diseases have no approved treatments.
Patients with COVID-19 pneumonia
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
Second Quarter 2020 Financial Results
Important Message Regarding COVID-19
Akari’s clinical trial sites are based in areas currently affected by the global outbreak of the coronavirus, and public health epidemics such as this can adversely impact the Company’s business as a result of disruptions, such as travel bans, quarantines, and interruptions to access the trial sites and supply chains, 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, the Company’s ongoing trials have been halted or disrupted. For example, the Phase I/II clinical trial in patients with AKC study has been halted and the Company expects that recruitment in the Phase III clinical trial in pediatric patients with HSCT-TMA will be delayed until the fourth quarter of 2020. 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 continued 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 the Company’s operations and workforce, including research and clinical trials and the ability to raise capital, could affect the operations of key governmental agencies, such as the FDA, which may delay the development of the Company’s product candidates and could result in the inability of 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 Company’s 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 target indications: bullous pemphigoid (BP), atopic keratoconjunctivitis (AKC), thrombotic microangiopathy (TMA), as well as COVID-19 pneumonia and related COVID diseases. Akari believes that the dual action of nomacopan on both C5 and LTB4 may be beneficial in AKC, BP and COVID-19 pneumonia. 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. You should not place undue reliance upon the Company’s forward looking statements. Except as required by law, the Company undertakes no obligation to revise or update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this press release. 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 successfully develop nomacopan as a treatment for COVID-19 related pneumonia and to successfully commercialize any product in that indication; our ability to obtain orphan drug designation in additional indications; risks inherent in drug development in general and risks specific to the development of potential treatments for COVID-19 related illnesses; uncertainties in obtaining successful clinical results for nomacopan and any other product candidates and unexpected costs that may result therefrom; difficulties enrolling patients in our clinical trials; our ability to enter into collaborative, licensing, and other commercial relationships and on terms commercially reasonable to us; 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 US 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 June 30, 2020 and December 31, 2019 (in U.S. Dollars, except share data)
June 30, 2020 | December 31, 2019 | |||||||
(Unaudited) | ||||||||
Assets | ||||||||
Current Assets: | ||||||||
Cash | $ | 12,746,266 | $ | 5,731,691 | ||||
Prepaid expenses and other current assets | 1,679,425 | 712,975 | ||||||
Deferred financing costs | - | 321,956 | ||||||
Total Current Assets | 14,425,691 | 6,766,622 | ||||||
Property and equipment, net | - | 5,013 | ||||||
Patent acquisition costs, net | 26,489 | 30,163 | ||||||
Total Assets | $ | 14,452,180 | $ | 6,801,798 | ||||
Liabilities and Shareholders' Equity (Deficit) | ||||||||
Current Liabilities: | ||||||||
Accounts payable | $ | 2,191,168 | $ | 1,228,772 | ||||
Accrued expenses | 1,941,083 | 4,228,604 | ||||||
Liabilities related to options and warrants | 6,981,022 | 3,116,880 | ||||||
Total Liabilities | 11,113,273 | 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: 3,386,573,113 and 2,245,865,913 at June 30, 2020 and December 31, 2019, respectively | 46,578,543 | 31,987,016 | ||||||
Additional paid-in capital | 112,989,141 | 110,498,824 | ||||||
Accumulated other comprehensive loss | (617,622 | ) | (348,860 | ) | ||||
Accumulated deficit | (155,611,155 | ) | (143,909,438 | ) | ||||
Total Shareholders' Equity (Deficit) | 3,338,907 | (1,772,458 | ) | |||||
Total Liabilities and Shareholders' Equity (Deficit) | $ | 14,452,180 | $ | 6,801,798 |
AKARI THERAPEUTICS, Plc
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - UNAUDITEDFor the Three and Six Months Ended June 30, 2020 and June 30, 2019(in U.S. Dollars)
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, 2020 | June 30, 2019 | June 30, 2020 | June 30, 2019 | |||||||||||||
Operating Expenses: | ||||||||||||||||
Research and development expenses | $ | 3,020,432 | $ | 3,593,341 | $ | 5,752,597 | $ | 1,274,981 | ||||||||
General and administrative expenses | 2,891,177 | 2,438,106 | 5,085,986 | 4,744,504 | ||||||||||||
Total Operating Expenses | 5,911,609 | 6,031,447 | 10,838,583 | 6,019,485 | ||||||||||||
Loss from Operations | (5,911,609 | ) | (6,031,447 | ) | (10,838,583 | ) | (6,019,485 | ) | ||||||||
Other Income (Expenses): | ||||||||||||||||
Interest income | 1,152 | 449 | 2,162 | 1,735 | ||||||||||||
Changes in fair value of option/warrant liabilities – (loss)/gain | (2,432,449 | ) | 1,830,689 | (1,122,648 | ) | (528,083 | ) | |||||||||
Foreign currency exchange gains (losses) | 27,992 | 86,438 | 261,396 | (109,198 | ) | |||||||||||
Other expenses | (1,741 | ) | (3,213 | ) | (4,044 | ) | (7,336 | ) | ||||||||
Total Other Income (Expenses) | (2,405,046 | ) | 1,914,363 | (863,134 | ) | (642,882 | ) | |||||||||
Net Loss | (8,316,655 | ) | (4,117,084 | ) | (11,701,717 | ) | (6,662,367 | ) | ||||||||
Other Comprehensive (Loss) Income: | ||||||||||||||||
Foreign Currency Translation Adjustment | (46,037 | ) | (160,116 | ) | (268,762 | ) | (52,948 | ) | ||||||||
Comprehensive Loss | $ | (8,362,692 | ) | $ | (4,277,200 | ) | $ | (11,970,479 | ) | $ | (6,715,315 | ) | ||||
Loss per ordinary share (basic and diluted) | $ | (0.00 | ) | $ | (0.00 | ) | $ | (0.00 | ) | $ | (0.01 | ) | ||||
Weighted average ordinary shares (basic and diluted) | 3,002,482,637 | 1,607,121,984 | 2,759,381,673 | 1,594,063,579 |
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
Source: Akari Therapeutics Plc