NEW YORK and LONDON, Sept. 22, 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 second quarter of 2021, as well as recent clinical progress.
Akari’s two lead programs, in BP and HSCT-TMA, are in Phase III clinical development and have been granted both Orphan Drug and Fast Track designations by the U.S. Food and Drug Administration (FDA). The Company also has earlier stage programs with nomacopan addressing ophthalmology and pulmonary diseases.
“We have made progress with our clinical pipeline since the beginning of 2021, and have two orphan disease programs in Phase III clinical development,” said Clive Richardson, Chief Executive Officer of Akari Therapeutics. “In parallel we are actively exploring partnering opportunities for disease areas such as those for the eye and the lung, using different routes of administration for nomacopan.”
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 HSCT-TMA
HSCT-TMA is a severe disease in pediatric patients with an estimated 80% mortality rate and no approved treatments.
Long term data
Our first PNH patient has now been treated with nomacopan for over five years. Over 35 cumulative patient years of long-term treatment data shows the drug is well tolerated with a marked clinical effect such that 79% of formerly transfusion dependent patients became transfusion independent.
OTHER CLINICAL PROGRAMS
Akari Therapeutics is also pursuing other earlier stage programs that are primarily focused on large disease areas with high unmet need. For these programs we are using alternative formulations of nomacopan (topical, nebulized or long acting), which provides an opportunity for separate partnering options.
Ophthalmology program
Lung program
Trauma
Histamine inhibitor
Second 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. 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 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 U.S. 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 June 30, 2021 and December 31, 2020(in U.S. dollars, except share data) | ||||||||
June 30,2021 | December 31,2020 | |||||||
(Unaudited) | ||||||||
Assets | ||||||||
Current Assets: | ||||||||
Cash | $ | 3,791,586 | $ | 14,055,777 | ||||
Prepaid expenses and other current assets | 1,012,451 | 521,880 | ||||||
Total Current Assets | 4,804,037 | 14,577,657 | ||||||
Patent acquisition costs, net | 25,546 | 27,150 | ||||||
Total Assets | $ | 4,829,583 | $ | 14,604,807 | ||||
Liabilities and Shareholders' Equity | ||||||||
Current Liabilities: | ||||||||
Accounts payable | $ | 1,685,138 | $ | 3,380,782 | ||||
Accrued expenses | 1,556,460 | 1,839,706 | ||||||
Total Liabilities | 3,241,598 | 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:3,964,979,023 and 3,847,331,923 at June 30, 2021 and December 31, 2020, respectively | 396,498 | 384,733 | ||||||
Additional paid-in capital | 141,883,409 | 139,734,651 | ||||||
Capital Redemption Reserve | 52,193,811 | 52,193,811 | ||||||
Accumulated other comprehensive loss | (420,086 | ) | (648,065 | ) | ||||
Accumulated deficit | (192,465,647 | ) | (182,280,811 | ) | ||||
Total Shareholders' Equity | 1,587,985 | 9,384,319 | ||||||
Total Liabilities and Shareholders' Equity | $ | 4,829,583 | $ | 14,604,807 | ||||
AKARI THERAPEUTICS, Plc | ||||||||||||||||
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - UNAUDITED | ||||||||||||||||
For the Three Months Ended June 30, 2021 and 2020 | ||||||||||||||||
(in U.S. dollars) | ||||||||||||||||
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, 2021 | June 30, 2020 | June 30, 2021 | June 30, 2020 | |||||||||||||
Operating Expenses: | ||||||||||||||||
Research and development expenses | $ | 2,183,349 | $ | 3,020,432 | $ | 5,712,733 | $ | 5,752,597 | ||||||||
General and administrative expenses | 2,146,652 | 2,891,177 | 4,165,938 | 5,085,986 | ||||||||||||
Total Operating Expenses | 4,330,001 | 5,911,609 | 9,878,671 | 10,838,583 | ||||||||||||
Loss from Operations | (4,330,001 | ) | (5,911,609 | ) | (9,878,671 | ) | (10,838,583 | ) | ||||||||
Other Income (Expenses): | ||||||||||||||||
Interest income | 1,515 | 1,152 | 5,250 | 2,162 | ||||||||||||
Changes in fair value of option/warrant liabilities – (loss)/gain | - | (1,555,609 | ) | - | (606,153 | ) | ||||||||||
Foreign currency exchange gains (losses) | (12,754 | ) | 27,992 | (298,608 | ) | 261,396 | ||||||||||
Other expenses | (5,095 | ) | (1,741 | ) | (12,807 | ) | (4,044 | ) | ||||||||
Total Other Income (Expenses) | (16,334 | ) | (1,528,206 | ) | (306,165 | ) | (346,639 | ) | ||||||||
Net Loss | (4,346,335 | ) | (7,439,815 | ) | (10,184,836 | ) | (11,185,222 | ) | ||||||||
Other Comprehensive (Loss) Income: | ||||||||||||||||
Foreign Currency Translation Adjustment | (78,118 | ) | (46,037 | ) | 227,979 | (268,762 | ) | |||||||||
Comprehensive Loss | $ | (4,424,453 | ) | $ | (7,485,852 | ) | $ | (9,956,857 | ) | $ | (11,453,984 | ) | ||||
Loss per ordinary share (basic and diluted) | $ | (0.00 | ) | $ | (0.00 | ) | $ | (0.00 | ) | $ | (0.01 | ) | ||||
Weighted average ordinary shares (basic and diluted) | 3,847,352,386 | 3,002,482,637 | 3,874,631,250 | 2,759,381,673 | ||||||||||||
For more information
Investor ContactPeter VozzoWestwicke/ICR(443) 213-0505peter.vozzo@westwicke.com
Media Contact:Sukaina Virji / Ashley Tapp / Maya BennisonConsilium Strategic CommunicationsAkari@consilium-comms.com
Source: Akari Therapeutics Plc