Akari Therapeutics Announces Fourth Quarter and Full Year 2017 Financial Results and Highlights Recent Clinical Progress
March 21 2018 - 7:00AM
Akari Therapeutics, Plc (NASDAQ:AKTX), a biopharmaceutical company
focused on the development and commercialization of innovative
therapeutics to treat orphan autoimmune and inflammatory diseases,
today announces its financial results for the fourth quarter and
full year ended December 31, 2017 and highlights progress on its
clinical development programs.
“We made significant progress in 2017 advancing our lead product
candidate, Coversin™, across our clinical pipeline of orphan
inflammatory diseases, most importantly in our Phase II trial for
patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) which met
its primary endpoint,” commented Dr. David Horn Solomon, Chief
Executive Officer of Akari Therapeutics. “With this Phase II trial
now completed and the selection of the dosing regimen which is
intended to be used in future clinical trials, we now look forward
to the opening of the first clinical site by the end of March for
our first Phase III trial of Coversin in patients with PNH using a
convenient patient administered sub-cutaneous (SC) dosing.”
“We believe Akari is well-positioned to move forward with its
priority programs in 2018. In addition to PNH, we are focused on
advancing Coversin into Phase II trials in the first half of 2018
in our other key disease targets involving both the complement and
leukotriene pathways, the eye disease atopic keratoconjuntivitis
(AKC) and the skin disorder bullous pemphigoid (BP), both of which
are orphan indications with significant unmet need. We are also
continuing our Phase II trial of Coversin in patients with aHUS,
which commenced in late 2017. Additionally, we are advancing
Coversin SC in a patient-convenient auto-injector pen device, and
are advancing Coversin in topical eye-drops for AKC, and a
long-acting formulation. Having ended 2017 with good momentum, 2018
is set to be an exciting year for the company as we work towards
commercializing treatments for orphan autoimmune and inflammatory
diseases."
Clinical Development Programs Highlights
Complement Program
Paroxysmal Nocturnal Hemoglobinuria (PNH)
- Regulatory clearance recently received in Europe to open the
first clinical trial site for CAPSTONE, the Phase III trial of
Coversin in PNH patients who have not previously been treated with
a complement inhibitor, in patient-convenient SC dosing.
- Primary endpoint met in Phase II COBALT clinical trial of
Coversin™ for patients with PNH who have never received a
complement blocking therapy. The last three patients enrolled into
the trial on the new dosing regimen of 45 mg per day saw a more
rapid decline in LDH than those in the original dosing
regimen.
- The 45mg dosing regimen is the intended dose for the Phase III
PNH trials of Coversin discussed with the U.S. Food and Drug
Administration (FDA) in September 2017.
- Seven of the eight enrolled patients in the Phase II COBALT
trial completed the 90-day trial.1 These patients
continue to be evaluated in a long-term safety study, CONSERVE, and
have been receiving Coversin subcutaneously for between 5 to 14
months. To date there have been no drug-related serious adverse
events reported and patients are self-administering.
- FDA granted Fast Track designation for Coversin for treatment
of PNH in patients who have polymorphisms conferring eculizumab
resistance.
Atypical Hemolytic Uremic Syndrome (aHUS)
- A Phase II clinical trial for Coversin in aHUS was initiated in
the fourth quarter of 2017.
Dual C5 and Leukotriene B4 Program
Atopic Keratoconjunctivitis (AKC) and Bullous Pemphigoid
(BP)
- The Company anticipates the start of two Phase II clinical
trials, in the inflammatory-mediated eye disorder AKC and in the
skin inflammatory disease BP, in the first half of 2018. In AKC,
Coversin expected to be delivered in a topical eye drop
formulation.
Fourth Quarter and Full Year 2017 Financial
Results
- Cash position: As of December 31, 2017, the Company had cash
and cash equivalents of $28.1 million, as compared to cash, cash
equivalents and short term investments of $44.1 million as of
December 31, 2016.
- Research and development (R&D) expenses: R&D expenses
in the fourth quarter of 2017 were $7.1 million as compared to $6.6
million in the same quarter the prior year. R&D expenses for
full year 2017 were $23.3 million, as compared to $17.3 million for
the prior year. These increases were due primarily to
expenses associated with the expanded clinical trial programs.
- General and administrative (G&A) expenses: G&A expenses
in the fourth quarter of 2017 were $3.7 million, as compared to
$3.3 million in the same quarter last year, and, for the full year
2017, $11.7 million as compared to $9.9 million in 2016. These
increases were due primarily to higher legal, accounting and
professional service fees, and increased personnel and recruiting
expenses, offset by lower share-based compensation expense.
- Net loss: Net loss for the fourth quarter of 2017 was $9.3
million compared to a net loss of $8.3 million for the same period
in 2016. Net loss for full year 2017 was $32.6 million, compared to
$18.1 million for full year 2016. These year over year increases in
net loss were due primarily to higher R&D and G&A expenses
in 2017.
Guidance
Based on its current cash position and operating plan, the
Company expects that it has sufficient cash to fund operations into
the second quarter of 2019. This estimate assumes no additional
funding from new partnership agreements or debt or equity financing
events.
1For the seven patients that completed the
study, LDH as a multiple of ULN (xULN) was 1.4, 2.2, 2.3, 1.4, 1.3,
1.6 and 1.3 at day 28; 1.5, 2.1, 1.8, 1.5, 1.3, 1.4 and 2.2 at day
60; and 1.6, 2.4, 2.0, 1.9, 1.2, 1.5 and 2.5 at day 90.
Conference Call
Management will conduct a conference call at 8:30 a.m. ET today
to review the Company's fourth quarter and full year 2017 financial
results. The call can be accessed by dialing (844) 461-9933 or
(636) 812-6633 (international), and referencing conference ID
2096211. The conference call will also be webcast live over the
Internet and can be accessed on the "Events & Presentations"
page under the "Investors & Media" section of the Akari
Therapeutics website, www.akaritx.com, prior to the event. A replay
of the webcast will be available for at least 30 days following the
call at www.akaritx.com.
About Akari Therapeutics
Akari is a biopharmaceutical company focused on developing
inhibitors of acute and chronic inflammation, specifically the
complement and the eicosanoid system for the treatment of rare and
orphan diseases, in particular those where the complement system or
leukotrienes or both complement and leukotrienes together play a
primary role in disease progression. Akari's lead drug candidate
Coversin™ is a C5 complement inhibitor currently being evaluated in
paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic
uremic syndrome (aHUS). In addition to its C5 inhibitory activity,
Coversin independently and specifically inhibits leukotriene B4
(LTB4) activity. Akari intends to evaluate Coversin in two
conditions, the skin and eye diseases bullous pemphigoid and atopic
keratoconjunctivitis, where the dual action of Coversin on both C5
and LTB4 may be beneficial. Akari is also developing other tick
derived proteins, including long 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. 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, an inability or delay in obtaining required
regulatory approvals for Coversin and any other product candidates,
which may result in unexpected cost expenditures; risks inherent in
drug development in general; uncertainties in obtaining successful
clinical results for Coversin and any other product candidates and
unexpected costs that may result therefrom; failure to realize any
value of Coversin 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 Coversin may not
be as large as expected; risks associated with the putative
shareholder class action and SEC requests for information;
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; our inability to obtain additional
capital on acceptable terms, or at all; unexpected cost increases
and pricing pressures; uncertainties of cash flows and inability to
meet working capital needs; 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 and in our Report on Form 6-K filed with the
SEC on October 17, 2017. 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 |
As of December 31, 2017 and December 31, 2016 |
(in U.S. Dollars, except share data) |
|
|
|
|
|
|
|
|
|
|
December 31, 2017 |
|
December 31, 2016 |
Assets |
|
|
|
|
|
|
|
Current
Assets: |
|
|
|
Cash and
cash equivalents |
$ |
28,106,671 |
|
|
$ |
34,098,812 |
|
Short-term investments |
$ |
- |
|
|
|
10,021,963 |
|
Prepaid
expenses and other current assets |
$ |
706,415 |
|
|
|
1,513,006 |
|
Total
Current Assets |
$ |
28,813,086 |
|
|
|
45,633,781 |
|
|
|
|
|
Restricted deposit |
$ |
142,235 |
|
|
$ |
142,168 |
|
Property and equipment,
net |
$ |
55,898 |
|
|
|
58,364 |
|
Patent acquisition
costs, net |
$ |
39,124 |
|
|
|
39,365 |
|
Total
Assets |
$ |
29,050,343 |
|
|
$ |
45,873,678 |
|
|
|
|
|
Liabilities and Shareholders' Equity |
|
|
|
|
|
|
|
Current
Liabilities: |
|
|
|
Accounts
payable |
$ |
1,971,161 |
|
|
|
2,214,313 |
|
Accrued
expenses |
$ |
1,970,873 |
|
|
|
1,837,647 |
|
Liability
related to stock options and warrants |
$ |
5,081,335 |
|
|
|
7,662,808 |
|
Total
Current Liabilities |
$ |
9,023,369 |
|
|
|
11,714,768 |
|
|
|
|
|
Other
long-term liability |
$ |
48,003 |
|
|
|
56,360 |
|
Total
liabilities |
$ |
9,071,372 |
|
|
|
11,771,128 |
|
|
|
|
|
Commitments and Contingencies |
|
|
|
|
|
|
|
Shareholders'
Equity: |
|
|
|
Share
capital GBP of .01 par value |
|
|
|
Authorized: 10,000,000,000 and 5,000,000,000 ordinary shares;
issued and outstanding: |
|
|
1,525,693,393 and 1,177,693,383 at December 31, 2017 and 2016,
respectively |
|
22,927,534 |
|
|
|
18,340,894 |
|
Additional paid-in capital |
|
104,799,550 |
|
|
|
90,979,363 |
|
Accumulated other comprehensive loss |
|
(236,246 |
) |
|
|
(280,097 |
) |
Accumulated deficit |
|
(107,511,867 |
) |
|
|
(74,937,610 |
) |
Total Shareholders'
Equity |
|
19,978,971 |
|
|
|
34,102,550 |
|
Total Liabilities and
Shareholders' Equity |
|
29,050,343 |
|
|
$ |
45,873,678 |
|
|
|
AKARI THERAPEUTICS, Plc |
CONSOLIDATED STATEMENTS OF COMPREHENSIVE
LOSS |
(in U.S. Dollars) |
|
|
Twelve Months Ended |
|
Three Months Ended |
|
Dec 31, 2017 |
|
Dec 31, 2016 |
|
Dec 31, 2017 |
|
Dec 31, 2016 |
|
|
|
|
|
(Unaudited) |
|
(Unaudited) |
Operating
Expenses: |
|
|
|
|
|
|
|
Research
and development costs |
$ |
23,285,279 |
|
|
$ |
17,306,001 |
|
|
$ |
7,117,853 |
|
|
$ |
6,569,519 |
|
General
and administrative expenses |
|
11,673,910 |
|
|
|
9,940,557 |
|
|
|
3,667,813 |
|
|
|
3,283,703 |
|
Excess
Consideration |
|
- |
|
|
|
- |
|
|
|
|
|
Total Operating
Expenses |
|
34,959,189 |
|
|
|
27,246,558 |
|
|
|
10,785,666 |
|
|
|
9,853,222 |
|
Loss from
Operations |
|
(34,959,189 |
) |
|
|
(27,246,558 |
) |
|
|
(10,785,666 |
) |
|
|
(9,853,222 |
) |
|
|
|
|
|
|
|
|
Other Income
(Expense): |
|
|
|
|
|
|
|
Interest
income |
|
175,393 |
|
|
|
143,195 |
|
|
|
51,036 |
|
|
|
45,398 |
|
Changes
in fair value of option/warrant liabilities-gains |
|
2,581,473 |
|
|
|
8,733,350 |
|
|
|
1,571,468 |
|
|
|
1,598,578 |
|
Foreign
exchange (losses)/gains |
|
(358,540 |
) |
|
|
272,985 |
|
|
|
(127,214 |
) |
|
|
(71,392 |
) |
Other
expenses |
|
(13,394 |
) |
|
|
(43,969 |
) |
|
|
(2,779 |
) |
|
|
(5,481 |
) |
Total Other Income
(Expense) |
|
2,384,932 |
|
|
|
9,105,561 |
|
|
|
1,492,511 |
|
|
|
1,567,103 |
|
|
|
|
|
|
|
|
|
Net Loss |
|
(32,574,257 |
) |
|
|
(18,140,997 |
) |
|
|
(9,293,155 |
) |
|
|
(8,286,119 |
) |
|
|
|
|
|
|
|
|
Other
Comprehensive Income (Loss): |
|
|
|
|
|
|
|
Foreign
Currency Translation Adjustment |
|
43,851 |
|
|
|
(436,577 |
) |
|
|
52,153 |
|
|
|
61,116 |
|
|
|
|
|
|
|
|
|
Comprehensive Loss |
$ |
(32,530,406 |
) |
|
$ |
(18,577,574 |
) |
|
$ |
(9,241,002 |
) |
|
$ |
(8,225,003 |
) |
|
|
|
|
|
|
|
|
Loss per
common share (basic and diluted) |
$ |
(0.03 |
) |
|
$ |
(0.02 |
) |
|
$ |
(0.01 |
) |
|
$ |
(0.01 |
) |
|
|
|
|
|
|
|
|
Weighted
average common shares (basic and diluted) |
|
1,247,293,388 |
|
|
|
1,177,693,383 |
|
|
|
1,453,823,828 |
|
|
|
1,177,693,383 |
|
|
|
For more informationInvestor Contact:
Peter VozzoWestwicke Partners(443)
213-0505peter.vozzo@westwicke.com
Media Contact:
Mary-Jane Elliott / Sukaina Virji / Nicholas BrownConsilium
Strategic Communications+44 (0)20 3709
5700Akari@consilium-comms.com
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