Full Press Release Details
Except as otherwise indicated herein or as
the context otherwise requires, references to "Akari," "we," "us," "our," the "Company"
and similar designations refer to Akari Therapeutics, PLC and its subsidiaries. When we refer to "you," we mean prospective
investors in the Company.
We are a clinical-stage biotechnology
company focused on developing advanced therapies for autoimmune and inflammatory diseases involving the complement (C5) and leukotriene
(LTB4) pathways. Each of these pathways has scientifically well-supported causative roles in the diseases we are targeting. We believe
that blocking early mediators of inflammation will prevent initiation and continual amplification of the processes that cause certain
diseases. Our activities since inception have consisted of performing research and development activities and raising capital.
Our lead product candidate,
nomacopan, is a recombinant small protein derived from a protein originally discovered in the saliva of the Ornithodoros moubata tick,
which modulates the host immune system to allow the parasite to feed without alerting the host to its presence or provoking an immune
response. Nomacopan is a second-generation complement inhibitor which acts on complement component-C5, preventing release of C5a and formation
of C5b-9 (also known as the membrane attack complex, or MAC), and independently and specifically also inhibits leukotriene B4, or
LTB4, activity, both elements that are often co-located as part of the immune/inflammatory response. The importance of nomacopan's
dual inhibitory action is therefore twofold. First, it can prevent inflammatory and prothrombotic activities of two key pathways, and
second, the pathways can be independently activated. Additionally, nomacopan's bio-physical properties allow it to be potentially
used in a variety of formulations, including subcutaneous, intravenous, topical or inhaled routes of administration.
Nomacopan is a recombinant
small protein (16,769 Da) derived from a protein originally discovered in the saliva of the Ornithodoros moubata tick, where it modulates
the host immune system to allow the parasite to feed without alerting the host to its presence or provoking an immune response.
Nomacopan has received orphan
drug designation from the U.S. Food and Drug Administration, or the FDA, for use in HSCT-TMA and BP, and the European Medicines Agency,
or the EMA, for PNH, GBS and BP (each as defined below). Orphan drug designation provides us with certain benefits and incentives, including
a period of marketing exclusivity if marketing authorization of the drug is ultimately received for the designated indication. The receipt
of orphan drug designation status does not change the regulatory requirements or process for obtaining marketing approval and the designation
does not mean that marketing approval will be received.
We have received Fast Track
designation from the FDA for the investigation of nomacopan for the treatment of pediatric HSCT-TMA and for the treatment of PNH in patients
who have polymorphisms conferring Soliris (eculizumab) resistance and the treatment of BP. The Fast Track program was created by
the FDA to facilitate the development and expedite the review of new drugs which show promise in treating a serious or life-threatening
disease and address an unmet medical need. Drugs with Fast Track designation may also qualify for priority review to expedite the FDA
review process, if relevant criteria are met.
Our clinical targets for nomacopan
are auto-immune and inflammatory diseases where the inhibition of both C5 and LTB4 are implicated and we are currently focused on advancing
nomacopan for the treatment of pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA). In November 2022,
the FDA granted the Rare Pediatric Disease Designation to nomacopan for the treatment of pediatric HSCT-TMA. .Based on Type C guidance
requested and received from the FDA, in February 2023, we announced that we are moving forward into design and planning for the pivotal
Part B of the Phase 3 clinical trial of nomacopan for treatment of pediatric HSCT-TMA in pediatric patients between 2 years and <18
years of age. We also announced we have added a new pipeline program that will develop nomacopan as a potential treatment for adult HSCT-TMA,
which will include a study that is supportive of the pediatric program. Study enrollment for the adult program is expected to begin in
2024. We additionally have a pre-clinical program of long-acting PAS-nomacopan in geographic atrophy (GA).
September 2022 Financing
On September 12, 2022, we entered into a
definitive agreement with healthcare-focused institutional investors and accredited investors alongside participation from certain existing
investors, including the Akari Executive Chairman of the Board of Directors, Dr. Ray Prudo, providing for the issuance of an aggregate
of 15,100,000 ADSs in a registered direct offering at $0.85 per ADS for aggregate gross proceeds of approximately $12.84 million, or the
September 2022 Financing. The offering initially closed on September 14, 2022, and a second closing was held on September 16,
2022. In addition, we issued to the investors in the Private Placement that closed simultaneously with the September 2022 Financing
(i) series A warrants exercisable to purchase up to 15,100,000 ADSs at an exercise price of $0.85 per ADS and (ii) series B
warrants exercisable to purchase up to 15,100,000 ADSs at an exercise price of $0.85 per ADS. The series A warrants and series B warrants
became exercisable immediately following the date of issuance and will expire two years following issuance, in the case of the series
A warrants, and seven years following issuance, in the case of the series B warrants. We agreed to pay A.G.P./Alliance Global Partners a
cash placement fee equal to 7% of the aggregate purchase price for the ADSs sold in the offering, expense reimbursement of up to $75,000
and a non-accountable expense allowance of $50,000. We paid an aggregate of $1,000,700 in placement agent fees and expenses.
Nasdaq Non-Compliance
On October 24, 2022, we were notified by
Nasdaq that we were not in compliance with the minimum bid price requirements set forth in Nasdaq Listing Rule 5550(a)(2) for
continued listing on the Nasdaq Capital Market, and in in accordance with the applicable Nasdaq rules, we were provided with a grace period,
through April 24, 2023, to regain compliance with this rule. We can regain compliance, if at any time during this 180-day period,
the closing bid price of our ADSs is at least $1.00 for a minimum of ten consecutive business days, in which case we will be provided
with a written confirmation of compliance and this matter will be closed. In the event we do not regain compliance after the initial 180-day
period, we may then be eligible for an additional time if we meet the continued listing requirement for market value of publicly held
shares and all other initial listing standards for the Nasdaq Capital Market, with the exception of the bid price requirement, and will
need to provide written notice of our intention to cure the deficiency during the second compliance period. If we cannot demonstrate compliance
by the end of the second 180-day period, Nasdaq staff will notify us that our ADSs are subject to delisting. In addition, as a result
of the expected accounting classification of the warrants issued in connection with our September 2022 registered direct offering
as liabilities, we believe our shareholders' equity will fall below the $2,500,000 shareholders' equity requirement set forth in
Nasdaq Listing Rule 5505(b)(1) for continued listing on the Nasdaq Capital Market as of December 31, 2022 and we expect
that once we file our Annual Report on Form 20-F for the year ended December 31, 2022, which is required by April 30, 2023,
we will receive a related notice of non-compliance from Nasdaq.
Appointment of Chief Medical Officer
In November 2022, we
appointed John F. Neylan, III, MD, as Executive Vice President, Chief Medical Officer. Dr. Neylan has more than 20 years of
experience in medical, clinical development, and R&D. Before joining Akari, he was Executive Vice President, Chief Medical Officer
and Head of Research for Angion Biomedica Corporation, where he led the development of therapies for chronic fibrotic conditions of the
lung and kidney, and acute organ injuries. Previously, he was Senior Vice President and Chief Medical Officer for Keryx Biopharmaceuticals
and Senior Vice President, Clinical Development for Genzyme Corporation, where he headed up therapeutic development for specialty metabolic
diseases including renal, cardiovascular, endocrine, and osteoarthritis indications. Dr. Neylan was the Vice President, Research &
Development at Wyeth Research where he led development of transplant immunosuppressants, antivirals/antibacterials, antiarrhythmics, chemotherapeutics,
and hemophilia factor replacements. He also served on multiple advisory committees for the FDA.
On March 1, 2023, we
entered into an agreement with Ray Prudo, our former Executive Chairman. The agreement was affective as of January 1, 2023. Under
the agreement, Dr. Prudo will hold office as Non-Executive Chairman and Class C Director for the remainder of his three-year
term which began at our 2021 annual general meeting, and thereafter will seek reappointment in accordance with the Company's Articles
of Association. Dr. Prudo's current annual director fee is $100,000.
Preliminary Financial Data for the Year
ended December 31, 2022
Our consolidated financial
statements for the year ended December 31, 2022 are not yet available. Accordingly, the information presented below reflects our
preliminary financial data subject to the completion of our financial closing procedures. As a result, this preliminary financial data
may differ from the actual results that will be reflected in our consolidated financial statements for the year when they are completed
and publicly disclosed. This preliminary financial data may change and those changes may be material. Accordingly, you should not place
undue reliance upon these preliminary estimates. Please see "Note Regarding Forward-Looking Statements."
Our expectations with respect
to our unaudited consolidated financial data for the period discussed below are based upon management estimates and are the responsibility
of management. Our independent registered public accounting firm BDO USA LLP, has not audited, reviewed, or compiled this
preliminary financial data. Accordingly, BDO USA LLP does not express an opinion or any other form of assurance with respect thereto.
We believe that the following information about our cash is helpful to an investor's understanding of our operating
As of December 31, 2022,