Akari Therapeutics, Plc (Nasdaq: AKTX), a 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 ended March 31, 2020, as well as recent
clinical progress.
“We remain focused on our mission of addressing severe
inflammatory diseases with significant unmet medical need. We are
pleased that our company is now in the process of planning or
undertaking pivotal trials in both BP and HSCT-TMA as well as
progressing next clinical steps for studies in atopic
keratoconjunctivitis (AKC) and COVID-19 pneumonia,” said Clive
Richardson, Chief Executive Officer of Akari Therapeutics.
Severe inflammatory diseases remain an area of high unmet need.
Akari continues to make progress driving its anti-inflammatory
programs forward, including the recent announcement of positive
topline results from our Phase II BP study in May.
First Quarter 2020 and Recent Clinical
Highlights
Akari’s lead programs are in BP, AKC, and HSCT-TMA where
clinical data with nomacopan has shown rapid and sustained clinical
improvement in patients. These diseases have no approved
treatments.
As previously disclosed, the Company is following regulatory and
health agency guidance related to the COVID-19 pandemic to help
ensure the safety of its employees and patients. The impact on
individual studies is detailed below.
Phase II clinical trial in patients with BP
- In May 2020, Akari announced positive topline results from its
fully recruited Phase II study of nomacopan in BP patients. The
study achieved no drug-related serious adverse events with 7 of 9
treated patients showing a rapid and clinically significant
reduction in Bullous Pemphigoid Disease Area Index (BPDAI) score.
Of the 7 responders, 3 showed an 80%+ reduction in BPDAI score and
3 an approximately 40% reduction in BPDAI score within six weeks of
starting nomacopan.
- As announced recently, the European Medicines Agency (EMA)
issued a positive opinion on Akari’s application for orphan
designation of nomacopan for the treatment of BP. The U.S. Food and
Drug Administration (FDA) granted orphan drug designation for
nomacopan for the treatment of BP in September 2019. The Company
now expects to meet with the FDA and EMA to discuss a pivotal trial
design in the third quarter of 2020.
Phase III clinical trial in pediatric patients with
HSCT-TMA
- During Q1 2020, Akari initiated a pivotal Phase III trial for
HSCT-TMA with nomacopan following the opening of an Investigational
New Drug (IND) application by the FDA. As a result of the COVID-19
pandemic, although the Company is continuing the process of site
openings in the U.S. and Europe, it is anticipated that site
initiations will be delayed to later in 2020. Akari has both FDA
fast track for pediatric patients and orphan drug designation
status for this program.
Phase I/II clinical trial in patients with
AKC
- The Company completed Part A of the Phase I/II clinical trial
in severe AKC patients who showed a rapid overall improvement of a
mean 55% in the composite clinical score. The nomacopan eye drops
were found to be comfortable and well tolerated with no reported
drug related serious adverse events. Enrollment in the Part B
placebo-controlled efficacy arm of the study has now been paused
due to the COVID-19 crisis and we anticipate an interim update in
the middle of 2020.
Patients with COVID-19 pneumonia
- The Company believes nomacopan’s dual inhibition of both the
complement (C5) and leukotriene (LTB4) pathways makes the drug
potentially well suited for the treatment of patients with COVID-19
pneumonia and related COVID disease. Leukotriene inhibition is a
validated pathway for the treatment of severe lung inflammation and
LTB4 is a potent granulocyte and leukocyte attractant which in turn
are key drivers of the damaging cytokine storm that underpins acute
respiratory distress syndrome (ARDS). Likewise, there is growing
evidence of the role of the complement pathway in the microthrombi
and organ damage associated with COVID-19 pneumonia.
- In pre-clinical lung inflammation models including a study of
viral induced lung inflammation, nomacopan (formerly known as
Coversin) showed significant reductions in key lung inflammatory
markers such as neutrophils and lung vascular leakage (Garcia et
al., 2013; Roversi et al., 2013). Likewise in sepsis models
(Huber-Lang et al., 2014) nomacopan has shown significant
downregulation of a wide range of pro-inflammatory cytokines and
chemokines including TNF, IL-6, GM-CSF, IL1alpha, IL1beta, IL17,
MCP1 (CCL2), MIP1alpha (CCL3), MIP1beta (CCL4) which have all been
shown to be elevated in patients with COVID-19 disease.
- Akari is actively pursuing several clinical study opportunities
in patients with COVID-19 pneumonia in the UK and U.S. The Company
intends to provide additional detail when these programs are
finalized and approved.
First Quarter 2020 Financial Results
- As of March 31, 2020, the Company had cash of approximately
$7.8 million, compared to cash of $5.7 million as of December 31,
2019. In February and March 2020, the Company issued an aggregate
of 5,620,296 American Depositary Shares (the “ADSs”) at $1.70 per
ADS for aggregate gross proceeds of approximately $9.5 million. The
offering was led by existing investors of the Company, including
Dr. Ray Prudo, the Company’s chairman, as well as certain
accredited and institutional investors.
- In January 2020, the Company sold to Aspire Capital Fund, LLC
(Aspire Capital) a total of approximately $1.1 million of ordinary
shares. As of March 31, 2020, approximately $9.6 million of the
original $20 million facility remains available for draw down under
the equity purchase agreement entered into with Aspire Capital.
Subsequent to March 31, 2020, the Company sold a total of
approximately $1.3 million of ordinary shares and approximately
$8.3 million of the original $20 million facility remains available
for draw down under the equity purchase agreement entered into with
Aspire Capital.
- Research and development (R&D) expenses in the first
quarter of 2020 were approximately $2.7 million, as compared to
R&D income of approximately $2.3 million in the same quarter
the prior year. In the first quarter of 2019, the Company received
an R&D tax credit of $4.9 million which offset overall R&D
expenses. The Company did not recognize any R&D tax credits
during the first quarter of 2020. As a result of COVID-19 delaying
certain ongoing trials, we expect our clinical expenses to decrease
in the short term.
- General and administrative (G&A) expenses in the first
quarter of 2020 were approximately $2.2 million, as compared to
approximately $2.3 million in the same quarter last year.
- Total other income for the first quarter of 2020 was
approximately $1.5 million, as compared to total other expense of
$2.6 million in the same period the prior year. This change of
$4.1m was primarily due to approximately $3.7 million of higher
income related to the change in the fair value of the options and
warrants liabilities in the first quarter of 2020 compared to the
same period in 2019.
- Net loss for the first quarter of 2020 was approximately $3.4
million, compared to a net loss of approximately $2.5 million for
the same period in 2019. The increase in net loss was primarily due
to a combination of higher other income in 2020 offset by the
R&D tax credit of $4.9 million in the first quarter of
2019.
Important Message Regarding COVID-19
Akari’s clinical trial sites are based in areas currently
affected by coronavirus. Epidemics such as this can adversely
impact the business as a result of disruptions, such as travel
bans, quarantines, and interruptions to access the trial sites and
supply chain, which could result in material delays and
complications with respect to research and development programs and
clinical trials. Moreover, as a result of coronavirus, there is a
general unease of conducting unnecessary activities in medical
centers. As a consequence, ongoing trials have been halted or
disrupted. It is too early to assess the full impact of the
coronavirus outbreak on trials for nomacopan, but coronavirus is
expected to affect Akari’s ability to complete recruitment in the
original timeframe. The extent to which the coronavirus impacts
operations will depend on future developments, which are highly
uncertain and cannot be predicted with confidence, including the
duration and severity of the outbreak, and the actions that may be
required to contain the coronavirus or treat its impact. In
particular, the continued spread of the coronavirus globally, could
adversely impact Akari’s operations and workforce, including
research and clinical trials and the Company’s ability to raise
capital, could affect the operations of key governmental agencies,
such as the FDA, which may delay the development of our product
candidates and could result in the inability of our suppliers to
deliver components or raw materials on a timely basis or at all,
each of which in turn could have an adverse impact on the business,
financial condition and results of operation.
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
indications: bullous pemphigoid (BP), atopic keratoconjunctivitis
(AKC), thrombotic microangiopathy (TMA), and paroxysmal nocturnal
hemoglobinuria (PNH). Akari believes that the dual action of
nomacopan on both C5 and LTB4 may be beneficial in AKC and BP.
Akari is also developing other tick derived proteins, including
longer acting versions.
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 regarding, among other
things, statements related to the offering, the expected gross
proceeds and the expected closing of the offering. 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; our ability to enter into collaborative,
licensing, and other commercial relationships and on terms
commercially reasonable to us; 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 outbreak of coronavirus;
risks associated with the SEC investigation; 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 SHEETSAs of March
31, 2020 and December 31, 2019 (in U.S. Dollars, except share
data)
|
|
March 31, 2020 |
|
|
December 31, 2019 |
|
|
|
(Unaudited) |
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current Assets: |
|
|
|
|
|
|
|
|
Cash |
|
$ |
7,822,180 |
|
|
$ |
5,731,691 |
|
Prepaid expenses and other current assets |
|
|
1,828,444 |
|
|
|
712,975 |
|
Deferred financing costs |
|
|
288,705 |
|
|
|
321,956 |
|
Total Current Assets |
|
|
9,939,329 |
|
|
|
6,766,622 |
|
|
|
|
|
|
|
|
|
|
Property and equipment,
net |
|
|
2,096 |
|
|
|
5,013 |
|
Patent acquisition costs,
net |
|
|
27,566 |
|
|
|
30,163 |
|
Total Assets |
|
$ |
9,968,991 |
|
|
$ |
6,801,798 |
|
|
|
|
|
|
|
|
|
|
Liabilities and
Shareholders' Equity (Deficit) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current Liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
966,059 |
|
|
$ |
1,228,772 |
|
Accrued expenses |
|
|
2,630,857 |
|
|
|
4,228,604 |
|
Liabilities related to options and warrants |
|
|
4,556,448 |
|
|
|
3,116,880 |
|
Total Liabilities |
|
|
8,153,364 |
|
|
|
8,574,256 |
|
|
|
|
|
|
|
|
|
|
Commitments and
Contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shareholders' Equity
(Deficit): |
|
|
|
|
|
|
|
|
Share capital of £0.01 par value |
|
|
|
|
|
|
|
|
Authorized: 10,000,000,000 ordinary shares; issued and outstanding:
2,872,895,513 and 2,245,865,913 at March 31, 2020 and December 31,
2019, respectively |
|
|
40,085,648 |
|
|
|
31,987,016 |
|
Additional paid-in capital |
|
|
109,596,064 |
|
|
|
110,498,824 |
|
Accumulated other comprehensive loss |
|
|
(571,585 |
) |
|
|
(348,860 |
) |
Accumulated deficit |
|
|
(147,294,500 |
) |
|
|
(143,909,438 |
) |
Total Shareholders' Equity
(Deficit) |
|
|
1,815,627 |
|
|
|
(1,772,458 |
) |
Total Liabilities and
Shareholders' Equity (Deficit) |
|
$ |
9,968,991 |
|
|
$ |
6,801,798 |
|
AKARI THERAPEUTICS, Plc
CONDENSED CONSOLIDATED STATEMENTS OF
COMPREHENSIVE LOSS - UNAUDITEDFor the Three Months Ended March 31,
2020 and 2019(in U.S. Dollars)
|
|
Three Months Ended |
|
|
|
March 31, 2020 |
|
|
March 31, 2019 |
|
Operating Expenses: |
|
|
|
|
|
|
|
|
Research and development expenses (income) |
|
$ |
2,732,165 |
|
|
$ |
(2,318,360 |
) |
General and administrative expenses |
|
|
2,194,809 |
|
|
|
2,306,398 |
|
Total Operating Expenses
(Income) |
|
|
4,926,974 |
|
|
|
(11,962 |
) |
Income (Loss) from
Operations |
|
|
(4,926,974 |
) |
|
|
11,962 |
|
|
|
|
|
|
|
|
|
|
Other Income (Expenses): |
|
|
|
|
|
|
|
|
Interest income |
|
|
1,010 |
|
|
|
1,286 |
|
Changes in fair value of option and warrant liabilities –
gain/(loss) |
|
|
1,309,801 |
|
|
|
(2,358,772 |
) |
Foreign currency exchange gains (losses) |
|
|
233,404 |
|
|
|
(195,635 |
) |
Other expenses |
|
|
(2,303 |
) |
|
|
(4,124 |
) |
Total Other Income
(Expenses) |
|
|
1,541,912 |
|
|
|
(2,557,245 |
) |
|
|
|
|
|
|
|
|
|
Net Loss |
|
|
(3,385,062 |
) |
|
|
(2,545,283 |
) |
|
|
|
|
|
|
|
|
|
Other Comprehensive (Loss) Income: |
|
|
|
|
|
|
|
|
Foreign Currency Translation Adjustment |
|
|
(222,725 |
) |
|
|
107,168 |
|
|
|
|
|
|
|
|
|
|
Comprehensive Loss |
|
$ |
(3,607,787 |
) |
|
$ |
(2,438,115 |
) |
|
|
|
|
|
|
|
|
|
Loss per ordinary share (basic
and diluted) |
|
$ |
(0.00 |
) |
|
$ |
(0.00 |
) |
|
|
|
|
|
|
|
|
|
Weighted average ordinary
shares outstanding (basic and diluted) |
|
|
2,516,280,709 |
|
|
|
1,580,860,080 |
|
For more informationInvestor Contact:
Peter VozzoWestwicke(443) 213-0505peter.vozzo@westwicke.com
Media Contact:
Sukaina Virji / Lizzie SeeleyConsilium Strategic
Communications+44 (0)20 3709 5700Akari@consilium-comms.com
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