NEW YORK and LONDON, June 29, 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 financial results for the first 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. The Company also has earlier stage programs addressing ophthalmology, pulmonary diseases and trauma.
The Company is expanding its senior operational team in the U.S. and the UK, and recently appointed a new senior medical director, Dr. Sanjeev Khindri, former acting CMO at Galecto Biotech AB and global clinical leader within Johnson & Johnson with Phase II and Phase III experience. Dr. Khindri has responsibility for the BP and HSCT-TMA pivotal Phase III programs.
Over the last two years, Akari has made good progress in the development of its drug substance and drug product. Recently, it has successfully released the first commercial-scale GMP batch of an advanced strain for nomacopan expression, which provides at least a five-fold increase in yield of the ‘to be marketed’ drug substance.
“Akari continues to make progress advancing clinical development of nomacopan in multiple indications, including BP , HSCT-TMA, as well as eye and lung diseases”, said Clive Richardson, Chief Executive Officer of Akari Therapeutics. “Our commercial strategy is to focus on progressing our current orphan disease programs while partnering in other larger disease areas such as the eye and lung which utilize different routes of administration.”
PHASE III TRIALS
Two ongoing pivotal Phase III programs in orphan diseases with no specific approved treatments.
Phase III clinical trial in patients with BP
BP is a severe autoimmune blistering disease of the elderly.
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.
PNH - long term data
Long-term treatment data for PNH patients in phase II and phase III studies shows nomacopan is well tolerated, maintains its drug effect over multiple years, and shows a marked clinical effect with 79% of formerly transfusion dependent patients becoming transfusion independent. Akari believes this long-term clinical data de-risks key aspects of their clinical programs going forward.
OTHER CLINICAL PROGRAMS
These studies 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 for different formulations.
First 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 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 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, 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 SHEETS
As of March 31, 2021 and December 31, 2020
(in U.S. dollars, except share data)
|March 31, 2021||December 31, 2020|
|Prepaid expenses and other current assets||1,144,960||521,880|
|Total Current Assets||7,813,285||14,577,657|
|Property and equipment, net||-||-|
|Patent acquisition costs, net||26,460||27,150|
|Liabilities and Shareholders' Equity|
|Commitments and Contingencies|
|Share capital of $0.0001 par value par value|
|Authorized: 10,000,000,000 ordinary shares; issued and outstanding: 3,847,331,923 and 3,847,331,923 at March 31, 2021 and December 31, 2020, respectively||384,733||384,733|
|Additional paid-in capital||139,819,543||139,734,651|
|Capital Redemption Reserve||52,193,811||52,193,811|
|Accumulated other comprehensive loss||(341,968||)||(648,065||)|
|Total Shareholders' Equity||3,936,807||9,384,319|
|Total Liabilities and Shareholders' Equity||$||7,839,745||$||14,604,807|
AKARI THERAPEUTICS, Plc
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - UNAUDITED
For the Three Months Ended March 31, 2021 and 2020
(in U.S. dollars)
|Three Months Ended|
|March 31, 2021||March 31, 2020|
|Research and development expenses||$||3,529,384||$||2,732,165|
|General and administrative expenses||2,019,286||2,194,809|
|Total Operating Expenses||5,548,670||4,926,974|
|Loss from Operations||(5,548,670||)||(4,926,974||)|
|Other (Expenses) Income:|
|Changes in fair value of warrant liabilities – gain||-||949,456|
|Foreign currency exchange gains (losses)||(285,854||)||233,404|
|Total Other (Expenses) Income||(289,831||)||1,181,567|
|Other Comprehensive Income (Loss):|
|Foreign Currency Translation Adjustment||306,097||(222,725||)|
|Loss per ordinary share (basic and diluted)||$||(0.00||)||$||(0.00||)|
|Weighted average ordinary shares outstanding (basic and diluted)||3,847,331,923||2,516,280,709|
For more information
Sukaina Virji / Ashley Tapp / Maya Bennison
Consilium Strategic Communications
+44 (0)20 3709 5700