Akari Therapeutics Granted 180-Day Extension by Nasdaq to Meet Minimum Bid Price Requirement

Rhea-AI Summary

Akari Therapeutics, Plc (Nasdaq: AKTX) announced it has been granted an additional 180-day compliance period by Nasdaq, extending the deadline to regain compliance with the minimum bid price requirement until October 23, 2023. To maintain its listing, Akari must keep a minimum closing bid price of $1.00 per share for at least ten consecutive business days. There is no immediate impact on the company’s Nasdaq listing, and its American Depository Shares will continue to be traded. Akari is focused on developing advanced therapies for autoimmune diseases, with lead investigational asset nomacopan undergoing Phase 3 trials for pediatric HSCT-TMA. The company holds Orphan Drug and Fast Track designations from the FDA for this treatment.

Positive

• Received a 180-day extension from Nasdaq to comply with minimum bid price requirements.
• Nomacopan is in Phase 3 trials, showcasing a commitment to advancing therapy development.

Negative

• Needs to maintain a $1.00 minimum closing bid price to avoid potential delisting.
• Risks associated with obtaining regulatory approvals and uncertainties in achieving successful clinical results.

NEW YORK and LONDON, April 25, 2023 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, today announced that it has received notification from Nasdaq that Akari has been granted an additional 180-day period, or until October 23, 2023, to regain compliance with the Nasdaq minimum bid price requirement. Akari can regain compliance by maintaining a minimum closing bid price of $1.00 per share for a minimum of ten consecutive business days.

There is no immediate effect on the Nasdaq listing and Akari’s American Depository Shares (ADSs) will continue to trade during this period on the Nasdaq Capital Market under the symbol AKTX.

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 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

FAQ

What is the current Nasdaq compliance status of Akari Therapeutics (AKTX)?

Akari Therapeutics has until October 23, 2023, to regain compliance with Nasdaq's minimum bid price requirement.

What is required for Akari Therapeutics to maintain its Nasdaq listing?

Akari must maintain a minimum closing bid price of $1.00 per share for at least ten consecutive business days.

What is nomacopan and what is its significance to Akari Therapeutics?

Nomacopan is Akari's lead asset in Phase 3 trials for pediatric HSCT-TMA, aimed at addressing severe conditions in autoimmune diseases.

What designations has nomacopan received from the FDA?

Nomacopan has received Orphan Drug, Fast Track, and Rare Pediatric Disease designations from the FDA.