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 fourth quarter and full year ended December 31, 2019, as
well as recent business highlights.
“2019 was a very important year for the company as we generated
positive clinical data across all four of our programs. For BP, AKC
and HSCT-TMA, the rapid patient response we generally saw in our
clinical studies validates these disease targets for nomacopan
where the specific dual action of the drug provides a potential
significant differentiation with its inhibition of both the
complement (C5) and leukotriene (LTB4) pathways,” said Clive
Richardson, Chief Executive Officer of Akari Therapeutics. “In
2020, we look forward to expanding these programs further and plan
on focusing on preparatory work for potential pivotal studies in
anticipation of lessening the impact of the COVID-19 pandemic. At
the same time we are working with our employees, partners and
patients to help ensure their safety and maintain continuity where
possible.”
Full Year 2019 and Recent Business
Highlights
Akari’s strategy is to focus on orphan inflammatory diseases
with significant unmet medical need, where the role of the
complement and leukotriene systems are implicated. 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.
The Company is working with clinical sites and is following
regulatory and health agency guidance related to the COVID-19
pandemic to help ensure the safety of its employees and patients.
Our BP study has completed recruitment while our AKC study has
halted recruitment with around two thirds of patients recruited. We
expect delays in opening sites for our HSCT-TMA program. We expect
our long-term safety program will shift to being managed on a
country by country basis and some disruption is expected.
Phase II clinical trial in patients with BP
- In the fourth quarter of 2019, interim Phase II trial results
with nomacopan were presented at the 28th European Academy of
Dermatology and Venereology (EADV) Congress. The data showed that
four of the six patients were classified as at the upper limit of
moderate BP. The four patients saw a rapid and significant
improvement in symptoms, with a mean 63% decline in BPDAI score and
mean 68% decline in blister score by Day 42, with either no or
minimal early steroid treatment with one moderate patient having a
flare up post Day-28. The data showed nomacopan’s potential as a
possible treatment for BP with the additional and important benefit
of reducing steroid use which has multiple adverse effects
including a threefold increased risk of mortality. The Phase II
trial has completed recruitment, with full data expected in the
second quarter of 2020.
- During the third quarter of 2019, the FDA granted orphan drug
designation for nomacopan for the treatment of BP. The Company is
now evaluating pivotal trial designs.
Phase III clinical trial in pediatric patients with
HSCT-TMA
Initiated a pivotal Phase III trial for HSCT-TMA with nomacopan
following the opening of an IND by the FDA. As a result of the
COVID-19 pandemic, although we are looking to continue the process
of site openings, we anticipate this will be delayed and hence any
enrollment. This two-part Phase III study in pediatric patients
with HSCT-TMA is based on guidance from the Company’s end-of-Phase
II meeting with the FDA. Part A of the trial is a dose confirmation
study with the dosing agreed with FDA via their Model Informed Drug
Development Program (MIDD). Part B of the trial is a single arm
responder-based efficacy study that will follow an interim analysis
of Part A and a meeting with the FDA. This devastating condition
has an estimated 80% mortality rate in children, at elevated risk
of dying who will be recruited to the trial and has no approved
treatments. Akari has both FDA fast track pediatric patients and
orphan drug designation status for this program.
Phase I/II clinical trial in patients with
AKC
- In 2019, the Company successfully 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 stopped due to the COVID outbreak, but recruited
patients continue to be treated. We anticipate that when the trial
closes, we will have data on around two thirds of the target 19
patient study.
- During the first quarter of 2020, the Company announced new
preclinical data indicating that PAS-nomacopan, the long acting
form of the drug, significantly reduced both retinal inflammation
and intraocular VEGF. PAS-nomacopan was found to reduce intraocular
VEGF levels by as much as the anti-VEGF antibody with 74% (p=0.04)
and 68% (p=0.05) reductions respectively, compared to saline
control. Furthermore, while clinically assessed inflammation
increased in both the control and anti-VEGF groups by 49% and 33%,
respectively, PAS-nomacopan treatment resulted in a 9% reduction in
inflammation which represents a 58% difference compared to control
assessed by retinal fundoscopy (p=0.02). This therapeutic activity
across multiple pathogenic pathways (VEGF, inflammation and
complement) supports the potential for nomacopan as a new mode of
action for the treatment of back of the eye diseases.
PNH program
- The Company continues to accumulate positive long-term
treatment data, which includes more than 30 cumulative
patient-years of data with 14 PNH patients across four clinical
trials with no reported drug related serious adverse events.
Interim data from the Phase III CAPSTONE study on the first eight
PNH patients who were all transfusion dependent at entry to the
CAPSTONE trial show that all four patients randomized to nomacopan
were transfusion independent for the first six months of treatment
while all four patients on standard of care (SOC) remained
transfusion dependent. Recruitment into the Phase III
CAPSTONE study has been discontinued, although a PNH program may be
re-initiated to potentially take advantage of the new high
concentration formulation.
- The Company is currently developing a new higher concentration
formulation of nomacopan allowing a small volume (0.3mL), low
viscosity injection, with an insulin pen-like injector holding one
week’s daily dosing stable at room temperature, improving both
patient comfort and convenience. This drug presentation is relevant
to all of the diseases that the Company plans to treat by
subcutaneous dosing including BP and HSCT-TMA.
- Akari has been granted orphan status from the FDA
and the European Medicines Agency (EMA) for nomacopan for
treatment of PNH.
Fourth Quarter and Full Year 2019 Financial
Results
- As of December 31, 2019, the Company had cash of approximately
$5.7 million, compared to cash of $5.4 million as of December 31,
2018. In 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.
- During the year ended December 31, 2019, the Company sold to
Aspire Capital Fund, LLC (Aspire Capital) a total of approximately
$8.8 million of ordinary shares. Subsequent to December 31, 2019,
the Company sold a total of approximately $1.1 million of ordinary
shares and 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.
- Research and development (R&D) expenses in the fourth
quarter of 2019 were approximately $5.7 million, as compared to
approximately $2.4 million in the same quarter the prior year. This
increase was primarily due to higher manufacturing costs for
nomacopan in the fourth quarter of 2019. R&D expenses for full
year 2019 were approximately $8.7 million, as compared to
approximately $11.8 million for the prior year. This decrease was
primarily due to larger R&D tax credits received in 2019
compared to 2018, which offset overall R&D expenses.
- General and administrative (G&A) expenses in the fourth
quarter of 2019 were approximately $2.1 million, as compared to
approximately $2.4 million in the same quarter last year. This
decrease was primarily due to lower expenses associated with
professional fees and rent. G&A expenses for the full year 2019
were approximately $8.2 million, as compared to approximately $10.9
million in 2018. This decrease was primarily due to lower expenses
associated with legal fees, non-cash stock-based compensation,
professional fees and rent.
- Total other expense for the fourth quarter of 2019 was
approximately $50,000, as compared to total other income of $1.2
million in the same period the prior year, and, for the full year
2019, total other expense was approximately $140,000 as compared to
total other income of approximately $3.5 million in 2018. This
change was primarily due to approximately $3.3 million of higher
expense related to the change in the fair value of the stock option
liabilities in 2019 compared to 2018.
- Net loss for the fourth quarter of 2019 was approximately $7.9
million, compared to a net loss of approximately $3.5 million for
the same period in 2018. Net loss for full year 2019 was
approximately $17.1 million, as compared to approximately $16.5
million for the prior year.
A copy of the Company’s Annual Report on Form 20-F for the year
ended December 31, 2019 has been filed with the Securities and
Exchange Commission and posted on the Company’s website at
http://investor.akaritx.com/financial-information/sec-filings. You
may request a copy of the Company’s Form 20-F, at no cost to you,
by writing to the Financial Controller of the Company at 75/76
Wimpole Street, London W1G 9RT, United Kingdom or by calling the
Company at +44 20 8004 0261.
Important Message Regarding COVID-19
Public health epidemics or outbreaks could adversely impact our
business. In late 2019, a novel strain of COVID-19, also known as
coronavirus, was reported in Wuhan, China. While initially the
outbreak was largely concentrated in China, it has now spread to
several other countries, including in the United Kingdom and the
United States, and infections have been reported globally. In
particular, our clinical trial sites are based in areas currently
affected by coronavirus. Epidemics such as this can adversely
impact our 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 our 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, our 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 our ability to complete recruitment in our
original timeframe. The extent to which the coronavirus impacts our
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 our operations and workforce, including our
research and clinical trials and our 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 our 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 |
|
|
|
|
|
|
CONSOLIDATED BALANCE
SHEETS |
|
(in U.S. Dollars,
except share data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2019 |
December 31, 2018 |
Assets |
|
|
|
|
|
|
|
|
|
Current
Assets: |
|
|
|
|
Cash |
$ |
5,731,691 |
|
|
$ |
5,446,138 |
|
|
Prepaid expenses and other current assets |
|
712,975 |
|
|
|
1,423,184 |
|
|
Deferred Financing Costs |
|
321,956 |
|
|
|
585,000 |
|
|
Total
Current Assets |
|
6,766,622 |
|
|
|
7,454,322 |
|
|
|
|
|
|
|
Restricted
cash |
|
- |
|
|
|
521,829 |
|
|
Property and
equipment, net |
|
5,013 |
|
|
|
20,425 |
|
|
Patent
acquisition costs, net |
|
30,163 |
|
|
|
32,978 |
|
|
Total
Assets |
$ |
6,801,798 |
|
|
$ |
8,029,554 |
|
|
|
|
|
|
|
Liabilities and Shareholders' Equity |
|
|
|
|
|
|
|
|
|
Current
Liabilities: |
|
|
|
|
Accounts payable |
$ |
1,228,772 |
|
|
$ |
1,586,285 |
|
|
Accrued expenses |
|
4,228,604 |
|
|
|
1,489,558 |
|
|
Liabilities related to options and warrants |
|
3,116,880 |
|
|
|
1,842,424 |
|
|
Total
Current Liabilities |
|
8,574,256 |
|
|
|
4,918,267 |
|
|
|
|
|
|
|
Other
long-term liability |
|
- |
|
|
|
- |
|
|
Total
liabilities |
|
8,574,256 |
|
|
|
4,918,267 |
|
|
|
|
|
|
|
Commitments
and Contingencies |
|
|
|
|
|
|
|
|
|
Shareholders' (Deficit) Equity: |
|
|
|
|
Share capital of £0.01 par value |
|
|
|
|
Authorized: 10,000,000,000 ordinary shares; issued and
outstanding: |
|
|
|
|
2,245,865,913 and 1,580,693,413 at December 31, 2019 and 2018,
respectively |
|
31,987,016 |
|
|
|
23,651,277 |
|
|
Additional paid-in capital |
|
110,498,824 |
|
|
|
106,616,083 |
|
|
Accumulated other comprehensive loss |
|
(348,860 |
) |
|
|
(352,426 |
) |
|
Accumulated deficit |
|
(143,909,438 |
) |
|
|
(126,803,647 |
) |
|
Total
Shareholders' (Deficit) Equity |
|
(1,772,458 |
) |
|
|
3,111,287 |
|
|
Total
Liabilities and Shareholders' (Deficit) Equity |
$ |
6,801,798 |
|
|
$ |
8,029,554 |
|
|
|
|
|
|
|
AKARI
THERAPEUTICS, Plc |
CONSOLIDATED
STATEMENTS OF COMPREHENSIVE LOSS |
(in U.S.
Dollars) |
|
|
|
|
|
|
|
|
|
Twelve
Months Ended |
Three Months
Ended |
|
Dec 31, 2019 |
|
Dec 31, 2018 |
|
Dec 31, 2019 |
|
Dec 31, 2018 |
Operating
Expenses: |
|
|
|
|
|
|
|
Research and development expenses |
$ |
8,739,420 |
|
|
$ |
11,795,376 |
|
|
$ |
5,701,382 |
|
|
$ |
2,362,358 |
|
General and administrative expenses |
|
8,223,700 |
|
|
|
10,896,158 |
|
|
|
2,124,933 |
|
|
|
2,370,206 |
|
Litigation settlement (gain) loss |
|
- |
|
|
|
(2,700,000 |
) |
|
|
- |
|
|
|
- |
|
Total
Operating Expenses |
|
16,963,120 |
|
|
|
19,991,534 |
|
|
|
7,826,315 |
|
|
|
4,732,564 |
|
Loss from
Operations |
|
(16,963,120 |
) |
|
|
(19,991,534 |
) |
|
|
(7,826,315 |
) |
|
|
(4,732,564 |
) |
|
|
|
|
|
|
|
|
Other Income
(Expense): |
|
|
|
|
|
|
|
Interest income |
|
5,531 |
|
|
|
222,256 |
|
|
|
1,739 |
|
|
|
24,110 |
|
Changes in fair value of option and warrant liabilities - (loss)
gain |
|
(60,640 |
) |
|
|
3,238,911 |
|
|
|
(48,046 |
) |
|
|
1,161,783 |
|
Foreign currency exchange gain (loss) |
|
(67,256 |
) |
|
|
81,501 |
|
|
|
4,733 |
|
|
|
39,020 |
|
Other expenses |
|
(20,306 |
) |
|
|
(17,914 |
) |
|
|
(10,182 |
) |
|
|
(5,103 |
) |
Total Other
Income (Expenses) |
|
(142,671 |
) |
|
|
3,524,754 |
|
|
|
(51,756 |
) |
|
|
1,219,810 |
|
|
|
|
|
|
|
|
|
Net
Loss |
|
(17,105,791 |
) |
|
|
(16,466,780 |
) |
|
|
(7,878,071 |
) |
|
|
(3,512,754 |
) |
|
|
|
|
|
|
|
|
Foreign Currency Translation Adjustment |
|
3,566 |
|
|
|
(116,180 |
) |
|
|
53,233 |
|
|
|
(55,943 |
) |
|
|
|
|
|
|
|
|
Comprehensive Loss |
$ |
(17,102,225 |
) |
|
$ |
(16,582,960 |
) |
|
$ |
(7,824,838 |
) |
|
$ |
(3,568,697 |
) |
|
|
|
|
|
|
|
|
Loss per
ordinary share (basic and diluted) |
$ |
(0.01 |
) |
|
$ |
(0.01 |
) |
|
$ |
(0.00 |
) |
|
$ |
(0.00 |
) |
|
|
|
|
|
|
|
|
Weighted
average ordinary shares (basic and diluted) |
|
1,830,998,609 |
|
|
|
1,540,309,840 |
|
|
|
2,157,115,913 |
|
|
|
1,580,693,413 |
|
|
|
|
|
|
|
|
|
For more informationInvestor Contact:
Peter VozzoWestwicke(443) 213-0505peter.vozzo@westwicke.com
Media Contact:
Sukaina Virji / Nicholas Brown / Lizzie SeeleyConsilium
Strategic Communications+44 (0)20 3709
5700Akari@consilium-comms.com
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