NEW YORK and LONDON, May 01, 2023 (GLOBE NEWSWIRE) — Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, today announced financial results and highlights for the full year ended December 31, 2022, as well as recent company updates. Akari’s lead asset is investigational nomacopan, a novel bispecific inhibitor of both complement C5 and leukotriene B4 (LTB4). Nomacopan is currently in a Phase 3 clinical trial for pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA). Long-acting PAS-nomacopan is in pre-clinical development as a potential treatment for geographic atrophy (GA).
“Nomacopan’s distinctive dual mechanism of action against two key proinflammatory mediators, C5 and LTB4, we believe has blockbuster potential with the versatility to take the complement inhibitor category to the next level across multiple rare diseases and mass markets,” said Rachelle Jacques, Akari President and CEO. “During the last twelve months, Akari has made significant progress in realizing the promise of this novel asset by advancing to the registrational part of the Phase 3 clinical trials in pediatric HSCT-TMA and toward a regulatory filing for PAS-nomacopan to begin clinical trials in GA in the first half of 2024.”
Full Year 2022 Highlights and Recent Updates
Phase 3 clinical trials of nomacopan in pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA)
Pre-clinical development of long-acting PAS-nomacopan for geographic atrophy (GA) which is estimated to affect the vision of approximately one million people in the U.S. alone
Chemical Manufacturing and Controls (CMC)
Patents/Intellectual Property (IP)
Management Team
• The Akari management team was expanded with industry veterans John Neylan, M.D., Executive Vice President and Chief Medical Officer, and Melissa Bradford Klug, Chief Operating Officer
Full Year 2022 Financial Results
AKARI THERAPEUTICS, Plc
CONSOLIDATED BALANCE SHEETS
As of December 31, 2022 and 2021
(in U.S. Dollars, except share data)
December 31, | December 31, | |||||||
2022 | 2021 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash | $ | 13,249,945 | $ | 9,361,270 | ||||
Prepaid expenses | 465,244 | 2,173,528 | ||||||
Other current assets | 99,543 | 90,301 | ||||||
Total current assets | 13,814,732 | 11,625,099 | ||||||
Patent acquisition costs, net | 16,880 | 22,929 | ||||||
Total assets | $ | 13,831,612 | $ | 11,648,028 | ||||
Liabilities and Shareholders’ Equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | 946,658 | 1,788,563 | ||||||
Accrued expenses | 3,148,090 | 3,184,883 | ||||||
Warrant liability | 7,852,000 | — | ||||||
Other liability | 94,118 | — | ||||||
Liability related to deposits received for share subscriptions | — | 1,120,000 | ||||||
Total liabilities | $ | 12,040,866 | $ | 6,093,446 | ||||
Commitments and contingencies (Note 7) | ||||||||
Shareholders’ equity: | ||||||||
Share capital of $0.0001 par value | ||||||||
Authorized: 15,000,000,000 ordinary shares; issued and outstanding: 7,444,917,123 and 4,759,731,923 at December 31, 2022 and December 31, 2021, respectively | 744,492 | 475,973 | ||||||
Additional paid-in capital | 167,076,392 | 153,130,813 | ||||||
Capital redemption reserve | 52,193,811 | 52,193,811 | ||||||
Accumulated other comprehensive loss | (770,839 | ) | (540,967 | ) | ||||
Accumulated deficit | (217,453,110 | ) | (199,705,048 | ) | ||||
Total shareholders’ equity | 1,790,746 | 5,554,582 | ||||||
Total liabilities and shareholders’ equity | $ | 13,831,612 | $ | 11,648,028 |
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
For the Years Ended December 31, 2022, 2021 and 2020
(in U.S. Dollars, except share data)
Years Ended December 31, | ||||||||||||
2022 | 2021 | 2020 | ||||||||||
Operating expenses: | ||||||||||||
Research and development expenses | $ | 9,560,897 | $ | 9,133,455 | $ | 8,820,204 | ||||||
General and administrative expenses | 13,527,311 | 8,080,681 | 9,160,770 | |||||||||
Total operating expenses | 23,088,208 | 17,214,136 | 17,980,974 | |||||||||
Loss from operations | (23,088,208 | ) | (17,214,136 | ) | (17,980,974 | ) | ||||||
Other income (expense): | ||||||||||||
Interest income | 45,944 | 10,600 | 13,615 | |||||||||
Excess fair value of warrant liability over cash proceeds | (1,963,000 | ) | — | — | ||||||||
Change in fair value of warrant liability | 6,946,000 | — | 556,810 | |||||||||
Foreign currency exchange gains (losses) | 452,664 | (193,219 | ) | 350,939 | ||||||||
Other expenses | (141,462 | ) | (27,482 | ) | (22,007 | ) | ||||||
Total other income (expense) | 5,340,146 | (210,101 | ) | 899,357 | ||||||||
Net loss | (17,748,062 | ) | (17,424,237 | ) | (17,081,617 | ) | ||||||
Other comprehensive (loss) income: | ||||||||||||
Foreign currency translation adjustment | (229,872 | ) | 107,098 | (299,205 | ) | |||||||
Total comprehensive loss | $ | (17,977,934 | ) | $ | (17,317,139 | ) | $ | (17,380,822 | ) | |||
Net loss per ordinary share, basic and diluted | $ | (0.00 | ) | $ | (0.00 | ) | $ | (0.01 | ) | |||
Weighted average ordinary shares outstanding, basic and diluted | 6,243,462,410 | 4,292,112,667 | 3,159,037,588 |
A copy of the Company’s Annual Report on Form 20-F for the year ended December 31, 2022 was filed with the Securities and Exchange Commission and posted on the Company’s website at http://investor.akaritx.com/financial-information/sec-filings. The Company will deliver a hard copy of its Annual Report, including its complete audited consolidated financial statements, free of charge, to its shareholders upon request to Akari Investor Relations at 75/76 Wimpole Street, London W1G 9RT, United Kingdom or by phone at +44 20 8004 0270.
About Akari Therapeutics
Akari Therapeutics, plc (Nasdaq: AKTX) is a biotechnology company developing advanced therapies for autoimmune and inflammatory diseases. Akari’s lead asset, investigational nomacopan, is a bispecific recombinant inhibitor of complement C5 activation and leukotriene B4 (LTB4) activity. Akari’s pipeline includes a Phase 3 clinical trial program investigating nomacopan for severe pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA). Akari has been granted Orphan Drug, Fast Track and Rare Pediatric Disease designations from the FDA for nomacopan for the treatment of pediatric HSCT-TMA. Akari’s pipeline also includes a clinical program developing nomacopan for adult HSCT-TMA and pre-clinical research of long-acting PAS-nomacopan in geographic atrophy (GA). For more information about Akari, please visit akaritx.com.
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 there; 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 a resurgence 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.
For more information
Investor Contact:
Mike Moyer
LifeSci Advisors
(617) 308-4306
mmoyer@lifesciadvisors.com
Media Contact:
Eliza Schleifstein
Schleifstein PR
(917) 763-8106
eliza@schleifsteinpr.com
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