Akari Therapeutics Reports Third Quarter 2019 Financial Results And Highlights Recent Clinical Progress
November 04 2019 - 8:33AM
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 third quarter ended September 30, 2019 and recent clinical
progress.
“We are excited about the positive clinical data we are
accumulating in patients treated with nomacopan across our target
rare disease indications. The rapid and sustained clinical clinical
improvement combined with the positive long-term safety profile we
have observed in patients, helps to offer further validation of
nomacopan’s unique method of action as an inhibitor of both the
complement and leukotriene pathways,” said Clive Richardson, Chief
Executive Officer of Akari Therapeutics. “We look forward to
further progress across both our topical and subcutaneous clinical
programs in 2020 as we look to drive nomacopan through the clinic
and towards helping patients afflicted by these rare and
debilitating inflammatory conditions. In addition, we seek to
partner those programs in which a joint development approach can
produce a faster outcome.”
Third Quarter 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.
Further evidence for potential therapeutic benefits of
inhibition of C5 and LTB4 by nomacopan
In the last three months, the Company has announced preclinical
data in both BP and AKC demonstrating the likely combined role of
C5 and LTB4 in these two severe inflammatory conditions:
- In BP, an orphan condition with no approved treatment, the
Company announced new data demonstrating synergistic benefits of
nomacopan’s dual C5 and LTB4 inhibitory activity. This new study
was undertaken by Dr. Christian Sadik’s team at University of
Lubeck, Germany. These data were published in the August 2019
edition of JCI Insight [link].
- In AKC, a surface of the eye disease with no approved
treatment, the Company announced new data from the conjunctival
tissue of patients showing for the first time the presence of both
the C5a receptor and the leukotriene LTB4 receptor on the
conjunctival surface of the eye.
Pediatric HSCT-TMA
- A pivotal trial for HSCT-TMA with nomacopan is expected to
start in the fourth quarter of 2019. This devastating condition has
an estimated 80% mortality rate in children and has no approved
treatments. In August 2019, the FDA granted Fast Track designation
to nomacopan for the treatment of HSCT-TMA as well as orphan drug
designation for treatment of pediatric patients.
Phase II clinical trial in patients with BP
- Phase II trial results with nomacopan were presented at the
28th European Academy of Dermatology and Venereology (EADV)
Congress on October 10, 2019. 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 Bullous Pemphigoid Disease Area Index (BPDAI) score
and mean 68% decline in blister score by day 42, with either no or
minimal early steroid treatment. The data showed nomacopan’s
potential as monotherapy with the additional potential benefit of
reducing steroid use which has multiple adverse effects.
- During the third quarter of 2019, the FDA granted orphan drug
designation for nomacopan for the treatment of BP. The company is
now exploring pivotal trial designs.
Phase I/II clinical trial in patients with
AKC
- 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 in 16 patients
continues, with a data read out expected in the first quarter of
2020.
Paroxysmal nocturnal hemoglobinuria (PNH)
program
- The Company continues to accumulate positive long-term
treatment data, which includes over 20 cumulative patient-years of
data with no reported drug related serious adverse events. Our
ongoing Phase III PNH study in naïve patients is expected to have
an interim data readout in mid 2020 with the next stage subject to
our pen injector program which aims to hold one week’s supply of
nomacopan stable at room temperature with a daily 0.3ml
injection.
Third Quarter 2019 Financial Results
- As of September 30, 2019, the Company had cash of $6.3 million.
In addition, the Company received in October 2019 $2.9 million in
research and development tax credits from the UK tax authorities.
This compares to cash of $5.4 million as of December 31,
2018.
- During the third quarter of 2019, the Company sold to Aspire
Capital Fund, LLC (Aspire Capital) a total of $4.6 million of
ordinary shares. As of September 30, 2019, approximately $13.4
million of the original $20 million remains available for draw down
under the equity purchase agreement entered into with Aspire
Capital.
- Research and development (R&D) expenses in the third
quarter of 2019 were $1.8 million, as compared to R&D expenses
of $3.3 million in the same quarter the prior year. This decrease
was primarily due to the recognition of the aforementioned R&D
tax credit of $2.9 million in the third quarter of 2019, proceeds
of which were received in October 2019.
- General and administrative (G&A) expenses in the third
quarter of 2019 were $1.4 million, as compared to $2.4 million in
the same quarter last year. This decrease was primarily due to
lower expenses associated with professional fees and rent.
- Total other income for the third quarter of 2019 was $0.4
million, as compared to total other expense of $0.6 million in the
same period the prior year. This change was primarily due to $1.0
million of higher income related to the change in the fair value of
the stock option liabilities in 2019 compared to 2018.
- Net loss for the third quarter of 2019 was $2.8 million,
compared to a net loss of $3.6 million for the same period in 2018.
The decrease in net loss in the third quarter of 2019 was due
primarily to lower net R&D and G&A expenses, as well as
change in the fair value of the stock option liabilities previously
cited, offset by the one-time litigation settlement gain that was
recorded in the third quarter of 2018.
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 departure of our former Chief
Executive Officers and other executive officers; 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 September 30, 2019 and
December 31, 2018(in U.S. Dollars, except share data) |
|
|
|
|
|
|
|
|
|
September 30, 2019 |
|
|
December 31, 2018 |
|
|
|
(Unaudited) |
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current Assets: |
|
|
|
|
|
|
|
|
Cash |
|
$ |
6,268,667 |
|
|
$ |
5,446,138 |
|
Tax Credit Receivable |
|
|
2,902,987 |
|
|
|
- |
|
Prepaid expenses and other current assets |
|
|
1,058,527 |
|
|
|
1,423,184 |
|
Deferred financing costs |
|
|
402,042 |
|
|
|
585,000 |
|
Total Current Assets |
|
|
10,632,223 |
|
|
|
7,454,322 |
|
|
|
|
|
|
|
|
|
|
Restricted cash |
|
|
- |
|
|
|
521,829 |
|
Property and equipment,
net |
|
|
8,388 |
|
|
|
20,425 |
|
Patent acquisition costs,
net |
|
|
29,147 |
|
|
|
32,978 |
|
Total Assets |
|
$ |
10,669,758 |
|
|
$ |
8,029,554 |
|
|
|
|
|
|
|
|
|
|
Liabilities and
Shareholders' Equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current Liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
1,315,411 |
|
|
$ |
1,586,285 |
|
Accrued expenses |
|
|
3,035,056 |
|
|
|
1,489,558 |
|
Liability related to options |
|
|
2,053,966 |
|
|
|
1,842,424 |
|
Total Liabilities |
|
|
6,404,433 |
|
|
|
4,918,267 |
|
|
|
|
|
|
|
|
|
|
Shareholders' Equity: |
|
|
|
|
|
|
|
|
Share capital of £0.01 par value |
|
|
|
|
|
|
|
|
Authorized: 10,000,000,000 ordinary shares; issued and outstanding:
2,100,865,913 and 1,580,693,413 at September 30, 2019 and
December 31, 2018, respectively |
|
|
30,123,701 |
|
|
|
23,651,277 |
|
Additional paid-in capital |
|
|
110,774,033 |
|
|
|
106,616,083 |
|
Accumulated other comprehensive loss |
|
|
(402,094 |
) |
|
|
(352,426 |
) |
Accumulated deficit |
|
|
(136,230,315 |
) |
|
|
(126,803,647 |
) |
Total Shareholders'
Equity |
|
|
4,265,325 |
|
|
|
3,111,287 |
|
Total Liabilities and
Shareholders' Equity |
|
$ |
10,669,758 |
|
|
$ |
8,029,554 |
|
|
|
|
|
|
|
|
|
|
|
AKARI THERAPEUTICS, Plc |
|
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS -
UNAUDITEDFor the Three and Nine Months Ended September 30, 2019 and
September 30, 2018(in U.S. Dollars) |
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, 2019 |
|
|
September 30, 2018 |
|
|
September 30, 2019 |
|
|
September 30, 2018 |
|
Operating Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expenses |
|
$ |
1,763,057 |
|
|
$ |
3,303,790 |
|
|
$ |
3,038,038 |
|
|
$ |
9,433,018 |
|
General and administrative expenses |
|
|
1,354,263 |
|
|
|
2,382,153 |
|
|
|
6,098,767 |
|
|
|
8,537,191 |
|
Litigation settlement gain |
|
|
- |
|
|
|
(2,700,000 |
) |
|
|
- |
|
|
|
(2,700,000 |
) |
Total Operating Expenses |
|
|
3,117,320 |
|
|
|
2,985,943 |
|
|
|
9,136,805 |
|
|
|
15,270,209 |
|
Loss from Operations |
|
|
(3,117,320 |
) |
|
|
(2,985,943 |
) |
|
|
(9,136,805 |
) |
|
|
(15,270,209 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Income (Expenses): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
2,057 |
|
|
|
66,073 |
|
|
|
3,792 |
|
|
|
198,146 |
|
Changes in fair value of option liabilities – gain/(loss) |
|
|
316,541 |
|
|
|
(715,846 |
) |
|
|
(211,542 |
) |
|
|
2,077,128 |
|
Foreign currency exchange gains (losses) |
|
|
37,209 |
|
|
|
36,036 |
|
|
|
(71,989 |
) |
|
|
42,481 |
|
Other expenses |
|
|
(2,788 |
) |
|
|
6,425 |
|
|
|
(10,124 |
) |
|
|
(1,572 |
) |
Total Other Income
(Expenses) |
|
|
353,019 |
|
|
|
(607,312 |
) |
|
|
(289,863 |
) |
|
|
2,316,183 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss |
|
|
(2,764,301 |
) |
|
|
(3,593,255 |
) |
|
|
(9,426,668 |
) |
|
|
(12,954,026 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Comprehensive (Loss) Income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign Currency Translation Adjustment |
|
|
3,280 |
|
|
|
(65,848 |
) |
|
|
(49,668 |
) |
|
|
(60,237 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive Loss |
|
$ |
(2,761,021 |
) |
|
$ |
(3,659,103 |
) |
|
$ |
(9,476,336 |
) |
|
$ |
(13,014,263 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per ordinary share (basic
and diluted) |
|
$ |
(0.00 |
) |
|
$ |
(0.00 |
) |
|
$ |
(0.01 |
) |
|
$ |
(0.01 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average ordinary
shares outstanding (basic and diluted) |
|
|
1,971,025,222 |
|
|
|
1,528,682,540 |
|
|
|
1,721,098,272 |
|
|
|
1,526,700,724 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
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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