NEW YORK and LONDON, Dec. 03, 2021 (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 its financial results for the third quarter of 2021 and recent clinical progress.
Akari’s two lead programs, in BP and pediatric HSCT-TMA, are in Phase III clinical development and both have been granted Orphan Drug and Fast Track designations by the U.S. Food and Drug Administration (FDA). The Company also has earlier stage programs addressing ophthalmology and pulmonary diseases.
“During 2021, Akari has been very active and focused on the launch of our two orphan Phase III programs for BP and HSCT-TMA as well as the further development of our lung and eye franchises based on new formulations of our lead asset, nomacopan,” said Clive Richardson, Chief Executive Officer of Akari Therapeutics. “We now expect multiple readouts across our key ongoing and proposed programs over the next 12-18 months.”
Clinical highlights
Phase III clinical trial in patients with bullous pemphigoid
BP is a severe autoimmune blistering disease of the elderly with no specific approved treatments.
Phase III clinical trial in patients with pediatric HSCT-TMA
HSCT-TMA is a severe disease in pediatric patients with an approximately 80% mortality rate in patients with proteinuria and elevated terminal complement activity. There are no approved treatments.
OTHER CLINICAL PROGRAMS
Akari Therapeutics is also pursuing other earlier stage programs that are primarily focused on large disease areas with high unmet need and where complement and leukotriene pathways are implicated. For these programs, the Company is using alternative formulations to the subcutaneous delivery of nomacopan including topical, nebulized or long-acting engineered forms, which provide an opportunity for separate partnering options.
Ophthalmology program
Lung program
Trauma
Histamine inhibitor
Third Quarter 2021 Financial Results
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 areas: bullous pemphigoid (BP), thrombotic microangiopathy (TMA), as well as programs in the eye and lung.
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 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; 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 U.S. Food and Drug Administration (FDA) and European Medicines Agency (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 COVID-19 pandemic; 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 Securities and Exchange Commission (SEC), 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 September 30, 2021 and December 31, 2020(in U.S. dollars, except share data) | ||||||||
September 30,2021 | December 31,2020 | |||||||
(Unaudited) | ||||||||
Assets | ||||||||
Current Assets: | ||||||||
Cash | $ | 13,390,989 | $ | 14,055,777 | ||||
Prepaid expenses and other current assets | 1,303,605 | 521,880 | ||||||
Total Current Assets | 14,694,594 | 14,577,657 | ||||||
Patent acquisition costs, net | 23,927 | 27,150 | ||||||
Total Assets | $ | 14,718,521 | $ | 14,604,807 | ||||
Liabilities and Shareholders' Equity | ||||||||
Current Liabilities: | ||||||||
Accounts payable | $ | 1,923,357 | $ | 3,380,782 | ||||
Accrued expenses | 1,432,463 | 1,839,706 | ||||||
Total Liabilities | 3,355,820 | 5,220,488 | ||||||
Commitments and Contingencies | ||||||||
Shareholders' Equity: | ||||||||
Share capital of $0.0001 par value par value Authorized: 10,000,000,000 ordinary shares; issued and outstanding: 4,759,731,923 and 3,847,331,923 at September 30, 2021 and December 31, 2020, respectively | 475,973 | 384,733 | ||||||
Additional paid-in capital | 153,057,340 | 139,734,651 | ||||||
Capital Redemption Reserve | 52,193,811 | 52,193,811 | ||||||
Accumulated other comprehensive loss | (447,415 | ) | (648,065 | ) | ||||
Accumulated deficit | (193,917,008 | ) | (182,280,811 | ) | ||||
Total Shareholders' Equity | 11,362,701 | 9,384,319 | ||||||
Total Liabilities and Shareholders' Equity | $ | 14,718,521 | $ | 14,604,807 | ||||
AKARI THERAPEUTICS, Plc | ||||||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - UNAUDITEDFor the Three and Nine Months Ended September 30, 2021 and September 30, 2020(in U.S. dollars) | ||||||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, 2021 | September 30, 2020 | September 30, 2021 | September 30, 2020 | |||||||||||||
Operating Expenses: | ||||||||||||||||
Research and development (income) expenses | $ | (430,157 | ) | $ | (1,592,531 | ) | $ | 5,282,576 | $ | 4,160,066 | ||||||
General and administrative expenses | 1,893,559 | 1,839,414 | 6,059,497 | 6,925,400 | ||||||||||||
Total Operating Expenses | 1,463,402 | 246,883 | 11,342,073 | 11,085,466 | ||||||||||||
Loss from Operations | (1,463,402 | ) | (246,883 | ) | (11,342,073 | ) | (11,085,466 | ) | ||||||||
Other Income (Expenses): | ||||||||||||||||
Interest income | 1,371 | 6,132 | 6,621 | 8,294 | ||||||||||||
Changes in fair value of warrant liabilities – gain | - | 1,003,521 | - | 397,368 | ||||||||||||
Foreign currency exchange gains (losses) | 14,224 | 156,360 | (284,384 | ) | 417,756 | |||||||||||
Other expenses | (3,554 | ) | (5,676 | ) | (16,361 | ) | (9,720 | ) | ||||||||
Total Other Income (expenses) | 12,041 | 1,160,337 | (294,124 | ) | 813,698 | |||||||||||
Net Loss (income) | (1,451,361 | ) | 913,454 | (11,636,197 | ) | (10,271,768 | ) | |||||||||
Other Comprehensive (Loss) Income: | ||||||||||||||||
Foreign Currency Translation Adjustment | (27,329 | ) | (3,676 | ) | 200,650 | (272,438 | ) | |||||||||
Comprehensive Loss (income) | $ | (1,478,690 | ) | $ | 909,778 | $ | (11,435,547 | ) | $ | (10,544,206 | ) | |||||
Loss per ordinary share (basic and diluted) | $ | (0.00 | ) | $ | (0.00 | ) | $ | (0.00 | ) | $ | (0.00 | ) | ||||
Weighted average ordinary shares (basic and diluted) | 4,645,842,719 | 3,386,573,113 | 4,134,526,690 | 3,336,002,895 | ||||||||||||
For more information
Investor Contact:Peter VozzoICR Westwicke(443) 213-0505peter.vozzo@westwicke.com
Media Contact:Sukaina Virji / Maya BennisonConsilium Strategic Communications+44 (0)20 3709 5700Akari@consilium-comms.com
Source: Akari Therapeutics Plc