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Akari Therapeutics Regains Compliance with Nasdaq Minimum Bid Price Requirement

Key Takeaway: Akari Therapeutics has announced that it has regained compliance with Nasdaq's minimum bid price requirement after its American Depository Shares (ADSs) closed at $1.00 or more for ten consecutive business days. The company continues to develop nomacopan, an investigational therapy for autoimmune diseases, and has received various designations from the FDA for its treatment of pediatric conditions. However, Akari faces several operational and regulatory challenges that could impact its future prospects.
Price reaction · baseline $133.6 (2023-09-01 close) · hit pre-market · 3 other AKTX headline(s) in the window, move may be shared
day 0 close
-6.6%
day 1
-4.8%
day 3 · peak
+12%

Market Sentiment Analysis

POSITIVE FACTORS

  • Akari Therapeutics has regained compliance with Nasdaq's minimum bid price requirement.
  • The company's ADSs have maintained a closing bid price of $1.00 or greater for 10 consecutive days.
  • Akari's investigational drug, nomacopan, is progressing through clinical trials.

CONCERNS & RISKS

  • The company faces risks related to funding operations and meeting working capital needs.
  • There are uncertainties regarding regulatory approvals for nomacopan and other candidates.
  • Challenges in patient enrollment for clinical trials may impact progress.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Cash runway
~7 mo
Medium dilution risk
Lead asset
Coversin
Phase 2 · Paroxysmal Nocturnal Hemoglobinuria (PNH)

Full Press Release Details

NEW YORK and LONDON, September 5, 2023(GLOBE NEWSWIRE) – Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases today announced the company has received written notification from Nasdaq that it has regained compliance with the minimum bid price requirement. The notification of compliance is a result of Akari’s American Depository Shares (ADSs) having a closing bid price of $1.00 per share or greater for 10 consecutive business days.
Akari’s ADSs continue to be listed and trade 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 and orphan drug designation from the European Commission for treatment in hematopoietic stem cell transplantation. 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:

Frequently Asked Questions

What did Akari Therapeutics announce recently?

Akari Therapeutics announced that it has regained compliance with Nasdaq's minimum bid price requirement.

What is the significance of the $1.00 bid price?

The $1.00 bid price indicates that Akari's ADSs have met Nasdaq's requirement for ten consecutive business days.

What is nomacopan?

Nomacopan is Akari's investigational therapy for autoimmune and inflammatory diseases.

What designations has nomacopan received?

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

What challenges does Akari face?

Akari faces risks related to funding, regulatory approvals, and patient enrollment for clinical trials.

Last updated: Sep 5, 2023