Akari Therapeutics Reports Second Quarter 2019 Financial Results And Highlights Recent Clinical Progress
August 29 2019 - 8:06AM
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 second quarter ended June 30, 2019 and recent clinical
progress.
“We are pleased with the progress we have made advancing our BP,
HSCT-TMA and AKC programs and are encouraged by the initial data we
have received to date in these programs,” said Clive Richardson,
Chief Executive Officer of Akari Therapeutics. “Both AKC and BP
have further planned clinical readouts this year, providing a
potential opportunity for advancing both programs into pivotal
trials in 2020 and further supporting the novel therapeutic role of
combined C5 and LTB4 treatment. In addition, we are planning to
start a pivotal clinical trial for HSCT-TMA in the fourth quarter
of this year.”
Second Quarter 2019 and Recent Business
Highlights
- Pediatric HSCT-TMA
- The Company continues to progress towards a pivotal trial for
HSCT-TMA with nomacopan, which is expected to start in the fourth
quarter of 2019. This condition has an estimated 80% mortality rate
in children with this severe disease, with currently no approved
treatments. In a March 2019 meeting, a framework for the trial
design was agreed with the U.S. Food and Drug Administration (FDA).
In August 2019, the FDA granted Fast Track designation for
nomacopan for the treatment of HSCT-TMA in pediatric patients.
- Phase II clinical trial in patients with BP
- Initial results from the first three patients with
mild-to-moderate BP in the ongoing Phase II trial with nomacopan
demonstrated a rapid reduction in BP Disease Area Index (BPDAI)
score and blistering of 52% and 87%, respectively, by day 42. There
were no drug related serious adverse events. The Company
anticipates new safety and efficacy data in mild-to-moderate
patients from this study to be given as an oral presentation at the
the 28th European Academy of Dermatology and Venereology (EADV)
Congress, October 10, 2019.
- In early August, the Company announced new data demonstrating
synergistic benefits of nomacopan’s dual C5 and LTB4 inhibitory
activity in pemphigoid disease, generated by Dr. Christian Sadik’s
group at University of Lubeck, Germany, and published in the August
2019 edition of JCI Insight [link].
- Phase I/II clinical trial in patients with AKC
- Successfully completed Part A of TRACKER, a Phase I/II clinical
trial evaluating the safety and efficacy of topical nomacopan in
patients with moderate-to-severe AKC. Results showed a rapid
response and an overall improvement of 55% in the composite
clinical score, which was composed of an improvement in symptoms of
62% and signs of 52% by Day 56. Three patients were treated with
twice daily nomacopan eye drops in addition to standard of care for
up to 56 days, with one patient completing 14 days and then
withdrawing for reasons unrelated to the study. All patients had
been on maximal topical cyclosporine, the standard of care, for at
least three months prior to entry. The nomacopan eye drops were
found to be comfortable and well tolerated with no serious adverse
events. Enrollment in the Part B placebo-controlled efficacy arm in
16 patients continues to progress, with data read out planned for
the fourth quarter of 2019.
- Clive Richardson has been appointed permanent Chief Executive
Officer of Akari after having served as interim Chief Executive
Officer since May, 2018
Upcoming Events and Milestones
- HSCT-TMA pivotal clinical trial expected to start in the fourth
quarter of 2019.
- Mild-to-moderate BP trial data to be presented at EADV
Congress, October 10, 2019.
- Completion of Part B of AKC Phase I/II trial by the fourth
quarter of 2019.
Second Quarter 2019 Financial Results
- Research and development (R&D) expenses in the second
quarter of 2019 were $3.6 million, as compared to R&D expenses
of $5.1 million in the same quarter the prior year. This decrease
was primarily due to lower manufacturing expenses as the Company
had previously manufactured clinical trial material for supply
through 2019, which was slightly offset by higher clinical trial
costs and personnel expenses. R&D expenses for the six months
ended June 30, 2019 were $1.3 million reflecting the receipt of a
Q1 R&D tax credit of $4.9 million.
- General and administrative (G&A) expenses in the second
quarter of 2019 were $2.4 million, as compared to $2.9 million in
the same quarter last year. This decrease was primarily due to
lower expenses associated with professional services, personnel and
rent, partially offset by higher stock-based non-cash compensation
expenses.
- Total other income for the second quarter of 2019 was $1.9
million, as compared to total other expense of $43,000 in the same
period the prior year. This change was primarily due to $2.0
million of higher income related to the change in the fair value of
the stock option liabilities in 2019 compared to 2018, and to
higher foreign exchange gains of approximately $39,000 in 2019 as
compared to 2018.
- Net loss for the second quarter of 2019 was $4.1 million,
compared to a net loss of $8.0 million for the same period in 2018.
The decrease in net loss in the second quarter of 2019 was due
primarily to the change in the fair value of the stock option
liabilities and foreign exchange gains previously cited,
accompanied by lower operating expenses in the second quarter of
2019.
- As of June 30, 2019, the Company had cash of $2.7 million, as
compared to cash of $5.4 million as of December 31, 2018. On July
3, 2019, the Company sold to certain institutional investors,
accredited investors and an existing shareholder, RPC Pharma Ltd.,
an affiliated entity of Dr. Ray Prudo, Akari’s Chairman, an
aggregate 2,368,392 registered American Depository Shares (ADSs) of
Akari at a purchase price of $1.90 per ADS, resulting in gross
proceeds of approximately $4.5 million. Additionally, for each ADS
purchased by investors, the investors received an unregistered
warrant to purchase one-half ADS. The warrants have an exercise
price of $3.00 per ADS, were exercisable upon their issuance and
will expire five years from the issuance date.
- As of June 30, 2019, the Company has sold to Aspire Capital
Fund, LLC (Aspire Capital) a total of $2.0 million of ordinary
shares. Subsequent to June 30, 2019, the Company sold to Aspire
Capital a further $3.5 million of ordinary shares and approximately
$14.5 million remains available for draw down under the purchase
agreement entered into with Aspire Capital.
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; 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.
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AKARI THERAPEUTICS, PlcCONDENSED CONSOLIDATED BALANCE SHEETSAs of
June 30, 2019 and December 31, 2018 (in U.S. Dollars, except
share data) |
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June 30, 2019 |
|
|
December 31, 2018 |
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|
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|
|
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|
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(Unaudited) |
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Assets |
|
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|
|
|
|
|
|
|
|
|
|
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Current Assets: |
|
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|
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|
|
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|
Cash |
|
$ |
2,736,663 |
|
|
$ |
5,446,138 |
|
Prepaid expenses and other current assets |
|
|
1,747,365 |
|
|
|
1,423,184 |
|
Deferred financing costs |
|
|
606,508 |
|
|
|
585,000 |
|
Total Current Assets |
|
|
5,090,536 |
|
|
|
7,454,322 |
|
|
|
|
|
|
|
|
|
|
Restricted cash |
|
|
17,364 |
|
|
|
521,829 |
|
Property and equipment,
net |
|
|
12,056 |
|
|
|
20,425 |
|
Patent acquisition costs,
net |
|
|
31,065 |
|
|
|
32,978 |
|
Total Assets |
|
$ |
5,151,021 |
|
|
$ |
8,029,554 |
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Liabilities and
Shareholders' (Deficiency) Equity |
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Current Liabilities: |
|
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|
|
Accounts payable |
|
$ |
1,481,536 |
|
|
$ |
1,586,285 |
|
Accrued expenses |
|
|
2,671,393 |
|
|
|
1,489,558 |
|
Liabilities related to options |
|
|
2,370,507 |
|
|
|
1,842,424 |
|
Total Liabilities |
|
|
6,523,436 |
|
|
|
4,918,267 |
|
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|
|
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Commitments and
Contingencies |
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Shareholders' (Deficiency)
Equity: |
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Share capital of £0.01 par value |
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Authorized: 10,000,000,000 ordinary shares; issued and
outstanding: |
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|
|
|
|
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1,650,693,413 and 1,580,693,413 at June 30, 2019 and
December 31, 2018, respectively |
|
|
24,538,137 |
|
|
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23,651,277 |
|
Additional paid-in capital |
|
|
107,960,836 |
|
|
|
106,616,083 |
|
Accumulated other comprehensive loss |
|
|
(405,374 |
) |
|
|
(352,426 |
) |
Accumulated deficit |
|
|
(133,466,014 |
) |
|
|
(126,803,647 |
) |
Total Shareholders'
(Deficiency) Equity |
|
|
(1,372,415 |
) |
|
|
3,111,287 |
|
Total Liabilities and
Shareholders' Equity |
|
$ |
5,151,021 |
|
|
$ |
8,029,554 |
|
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AKARI THERAPEUTICS, PlcCONDENSED CONSOLIDATED STATEMENTS OF
COMPREHENSIVE LOSS - UNAUDITEDFor the Three Months Ended June 30,
2019 and June 30, 2018(in U.S. Dollars) |
|
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Three Months Ended |
|
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Six Months Ended |
|
|
|
June 30, 2019 |
|
|
June 30, 2018 |
|
|
June 30, 2019 |
|
|
June 30, 2018 |
|
Operating Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expenses |
|
$ |
3,593,341 |
|
|
$ |
5,120,840 |
|
|
$ |
1,274,981 |
|
|
$ |
6,129,228 |
|
General and administrative expenses |
|
|
2,438,106 |
|
|
|
2,858,065 |
|
|
|
4,744,504 |
|
|
|
6,155,038 |
|
Total Operating Expenses |
|
|
6,031,447 |
|
|
|
7,978,905 |
|
|
|
6,019,485 |
|
|
|
12,284,266 |
|
Loss from Operations |
|
|
(6,031,447 |
) |
|
|
(7,978,905 |
) |
|
|
(6,019,485 |
) |
|
|
(12,284,266 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
Other Income (Expenses): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
449 |
|
|
|
67,436 |
|
|
|
1,735 |
|
|
|
132,073 |
|
Changes in fair value of option liabilities – gain/(loss) |
|
|
1,830,689 |
|
|
|
(152,557 |
) |
|
|
(528,083 |
) |
|
|
2,792,974 |
|
Foreign currency exchange gains (losses) |
|
|
86,438 |
|
|
|
47,421 |
|
|
|
(109,198 |
) |
|
|
6,446 |
|
Other expenses |
|
|
(3,213 |
) |
|
|
(5,591 |
) |
|
|
(7,336 |
) |
|
|
(7,998 |
) |
Total Other Income
(Expenses) |
|
|
1,914,363 |
|
|
|
(43,291 |
) |
|
|
(642,882 |
) |
|
|
2,923,495 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss |
|
|
(4,117,084 |
) |
|
|
(8,022,196 |
) |
|
|
(6,662,367 |
) |
|
|
(9,360,771 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
Other Comprehensive (Loss) Income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign Currency Translation Adjustment |
|
|
(160,116 |
) |
|
|
(27,188 |
) |
|
|
(52,948 |
) |
|
|
5,611 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive Loss |
|
$ |
(4,277,200 |
) |
|
$ |
(8,049,384 |
) |
|
$ |
(6,715,315 |
) |
|
$ |
(9,355,160 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per ordinary share (basic
and diluted) |
|
$ |
(0.00 |
) |
|
$ |
(0.01 |
) |
|
$ |
(0.00 |
) |
|
$ |
(0.01 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average ordinary
shares (basic and diluted) |
|
|
1,607,121,984 |
|
|
|
1,525,693,393 |
|
|
|
1,594,063,579 |
|
|
|
1,525,693,393 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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For more informationInvestor Contact:
Peter VozzoWestwicke Partners(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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