Akari Therapeutics Reports Second Quarter 2020 Financial Results and Highlights Recent Clinical Progress
September 01 2020 - 8:30AM
Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage
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,
2020, as well as recent clinical progress.
“Akari continues to make good clinical progress, and since the
beginning of the year has successfully completed its Phase II BP
program and now has a clear pathway towards U.S. regulatory
approval from the FDA. The HSCT-TMA program is set to commence
recruitment in the fourth quarter of 2020 and we have initiated a
COVID-19 pneumonia clinical program across multiple countries that
leverages the unique dual C5 and LTB4 inhibition of nomacopan,”
said Clive Richardson, Chief Executive Officer of Akari
Therapeutics.
Second Quarter 2020 and Recent Clinical
Highlights
Akari’s lead programs are in BP, HSCT-TMA, COVID-19 pneumonia
and AKC. These diseases have no approved treatments.
Patients with COVID-19 pneumonia
- Clinical studies both underway and planned for patients with
COVID-19 pneumonia in the U.S., U.K., and Brazil. In the U.S., a
proposed multi-center randomized clinical program is in regulatory
submission following the current treatment of patients via expanded
access programs. In Brazil, patient recruitment has been completed
for a proof of principle clinical study; potential progression into
a follow-on randomized study is expected in early fourth quarter
2020. In the UK, nomacopan has been selected by the AGILE COVID-19
clinical trial initiative, and in addition data from approximately
50 COVID-19 pneumonia patients are expected in early fourth quarter
2020 from an observational study focused on identifying potential
therapeutic biomarkers for optimizing use of nomacopan.
- Nomacopan has been shown in clinical trials to inhibit both
complement C5 activation and leukotriene B4 (LTB4), and has
significant potential to simultaneously inhibit both microthrombi
as well as block multiple cytokines (the cytokine storm) which
together drive COVID-19 pneumonia and associated organ damage.
Phase II clinical trial in patients with BP
- In August 2020, Akari announced a successful end-of-Phase II
meeting with the U.S Food and Drug Administration (FDA)
regarding its proposed pivotal Phase III program for the treatment
of BP, which is now expected to start in the first half of 2021.
The FDA has agreed to a two-part pivotal trial with Part A and Part
B having the same structure, duration, endpoints and target
population of moderate and severe BP patients. This follows
positive topline results from Akari’s fully recruited Phase II
study of nomacopan in BP patients previously announced in May 2020.
The study achieved no reported drug-related serious adverse events.
Seven of the nine treated patients showing a rapid and clinically
significant reduction in Bullous Pemphigoid Disease Area Index
(BPDAI) score, which measures the body surface area affected by
blisters. Of the seven responders, three showed an 80%+ reduction
in BPDAI score and three an approximately 40% reduction in BPDAI
score within six weeks of starting nomacopan.
- The European Medicines Agency (EMA) and the FDA have granted
orphan drug designation for nomacopan for the treatment of BP.
Phase III clinical trial in pediatric patients with
HSCT-TMA
- During the first quarter of 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, site initiations were delayed and
Akari expects enrollment to now commence in the fourth quarter of
2020. Akari has both FDA fast track for pediatric HSCT-TMA patients
and orphan drug designation status for this program.
Phase I/II clinical trial in patients with
AKC
- As previously disclosed, enrollment into Part B of this study
was paused due to the COVID-19 crisis. The study has now been
unblinded to help evaluate next steps. Of the 12 patients
recruited, a complete data set was available on 10 patients – two
from Part A and eight from Part B. In Part B, of the eight patients
recruited, six were placebo (four AKC patients and two other
surface of the eye diagnosis) and two were treated with nomacopan
(two AKC patients).
- As a first-in-eye Phase I/II study, the primary endpoint
measure was safety. Aggregating data from the eight AKC patients
from Part A and Part B shows no ocular treatment emergent serious
adverse events during the eight-week treatment period. Nomacopan is
delivered topically without preservatives and is pH neutral. A
comfort score measured after each eye drop installation showed the
drug was comfortable and well tolerated. In all four efficacy
categories (signs, symptoms, visual acuity and tear film break up)
the four nomacopan treated AKC patients achieved a higher improved
mean score than the four placebo AKC patients, however, the patient
numbers are too small to show statistical significance on efficacy
measures between the two treatment groups.
- The interim data are encouraging and show that nomacopan
eyedrops are safe and comfortable. Subject to operational
constraints created by COVID-19, Akari aims to collect additional
patient data with topical nomacopan. Akari recently received FDA
approval for an IND for treatment with topical nomacopan which
opens up the potential to broaden our topical ophthalmological
program.
Second Quarter 2020 Financial Results
- As of June 30, 2020, the Company had cash of approximately
$12.7 million, compared to cash of $5.7 million as of December 31,
2019. Subsequent to the end of the second quarter of 2020, the
Company received an additional $3.4 million in research &
development tax credits.
- On June 30, 2020, the Company entered into a securities
purchase agreement with Aspire Capital Fund, LLC (Aspire Capital)
which provides that Aspire Capital is committed to purchase up to
an aggregate of $30.0 million of the Company’s ADSs, with each ADS
representing one hundred ordinary shares, during a 30-month term of
the purchase agreement. As of June 30, 2020, $30.4 million remains
available under the facility together with a facility entered into
with Aspire in 2018.
- Research and development (R&D) expenses in the second
quarter of 2020 were approximately $3.0 million, as compared to
approximately $3.6 million in the same quarter the prior year. This
decrease was primarily due to lower drug manufacturing costs and
reductions of discretionary clinical expenses due to the COVID-19
outbreak delaying certain ongoing trials.
- General and administrative (G&A) expenses in the second
quarter of 2020 were approximately $2.9 million, as compared to
approximately $2.4 million in the same quarter last year. This
increase was primarily due to a one-time non-cash financing expense
of $900,000 related to the 2020 purchase agreement with Aspire
Capital. Higher expenses for insurance were partially offset by
lower expenses for stock-based compensation, office rent and legal
fees.
- Total other expense for the second quarter of 2020 was
approximately $2.4 million, as compared to total other income of
$1.9 million in the same period the prior year. This change of $4.3
million was primarily due to approximately $4.3 million of loss
related to the change in the fair value of the options and warrants
liabilities in the second quarter of 2020 compared to the same
period in 2019.
- Net loss for the second quarter of 2020 was approximately $8.3
million, compared to a net loss of approximately $4.1 million for
the same period in 2019. The increase in net loss was primarily due
to higher Total Other Expense in 2020 and the aforementioned
one-time non-cash financing expense related to the 2020 purchase
agreement with Aspire Capital.
Important Message Regarding COVID-19
Akari’s clinical trial sites are based in areas currently
affected by the global outbreak of the coronavirus, and public
health epidemics such as this can adversely impact the Company’s
business as a result of disruptions, such as travel bans,
quarantines, and interruptions to access the trial sites and supply
chains, 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, the Company’s ongoing trials have been halted or
disrupted. For example, the Phase I/II clinical trial in patients
with AKC study has been halted and the Company expects that
recruitment in the Phase III clinical trial in pediatric patients
with HSCT-TMA will be delayed until the fourth quarter of 2020. 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 continued
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 the Company’s operations and workforce, including research
and clinical trials and the ability to raise capital, could affect
the operations of key governmental agencies, such as the FDA, which
may delay the development of the Company’s product candidates and
could result in the inability of 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 Company’s 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
target indications: bullous pemphigoid (BP), atopic
keratoconjunctivitis (AKC), thrombotic microangiopathy (TMA), as
well as COVID-19 pneumonia and related COVID diseases. Akari
believes that the dual action of nomacopan on both C5 and LTB4 may
be beneficial in AKC, BP and COVID-19 pneumonia. 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. You should not place
undue reliance upon the Company’s forward looking statements.
Except as required by law, the Company undertakes no obligation to
revise or update any forward-looking statements in order to reflect
any event or circumstance that may arise after the date of this
press release. 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 successfully develop nomacopan as a
treatment for COVID-19 related pneumonia and to successfully
commercialize any product in that indication; our ability to obtain
orphan drug designation in additional indications; risks inherent
in drug development in general and risks specific to the
development of potential treatments for COVID-19 related illnesses;
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; our ability to enter into collaborative,
licensing, and other commercial relationships and on terms
commercially reasonable to us; 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 US 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 June
30, 2020 and December 31, 2019 (in U.S. Dollars, except share
data)
|
|
June 30, 2020 |
|
|
December 31, 2019 |
|
|
|
(Unaudited) |
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current Assets: |
|
|
|
|
|
|
|
|
Cash |
|
$ |
12,746,266 |
|
|
$ |
5,731,691 |
|
Prepaid expenses and other current assets |
|
|
1,679,425 |
|
|
|
712,975 |
|
Deferred financing costs |
|
|
- |
|
|
|
321,956 |
|
Total Current Assets |
|
|
14,425,691 |
|
|
|
6,766,622 |
|
|
|
|
|
|
|
|
|
|
Property and equipment,
net |
|
|
- |
|
|
|
5,013 |
|
Patent acquisition costs,
net |
|
|
26,489 |
|
|
|
30,163 |
|
Total Assets |
|
$ |
14,452,180 |
|
|
$ |
6,801,798 |
|
|
|
|
|
|
|
|
|
|
Liabilities and
Shareholders' Equity (Deficit) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current Liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
2,191,168 |
|
|
$ |
1,228,772 |
|
Accrued expenses |
|
|
1,941,083 |
|
|
|
4,228,604 |
|
Liabilities related to options and warrants |
|
|
6,981,022 |
|
|
|
3,116,880 |
|
Total Liabilities |
|
|
11,113,273 |
|
|
|
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:
3,386,573,113 and 2,245,865,913 at June 30, 2020 and December 31,
2019, respectively |
|
|
46,578,543 |
|
|
|
31,987,016 |
|
Additional paid-in capital |
|
|
112,989,141 |
|
|
|
110,498,824 |
|
Accumulated other comprehensive loss |
|
|
(617,622 |
) |
|
|
(348,860 |
) |
Accumulated deficit |
|
|
(155,611,155 |
) |
|
|
(143,909,438 |
) |
Total Shareholders' Equity
(Deficit) |
|
|
3,338,907 |
|
|
|
(1,772,458 |
) |
Total Liabilities and
Shareholders' Equity (Deficit) |
|
$ |
14,452,180 |
|
|
$ |
6,801,798 |
|
AKARI THERAPEUTICS, Plc
CONDENSED CONSOLIDATED STATEMENTS OF
COMPREHENSIVE LOSS - UNAUDITEDFor the Three and Six Months Ended
June 30, 2020 and June 30, 2019(in U.S. Dollars)
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, 2020 |
|
|
June 30, 2019 |
|
|
June 30, 2020 |
|
|
June 30, 2019 |
|
Operating Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development expenses |
|
$ |
3,020,432 |
|
|
$ |
3,593,341 |
|
|
$ |
5,752,597 |
|
|
$ |
1,274,981 |
|
General and administrative expenses |
|
|
2,891,177 |
|
|
|
2,438,106 |
|
|
|
5,085,986 |
|
|
|
4,744,504 |
|
Total Operating Expenses |
|
|
5,911,609 |
|
|
|
6,031,447 |
|
|
|
10,838,583 |
|
|
|
6,019,485 |
|
Loss from Operations |
|
|
(5,911,609 |
) |
|
|
(6,031,447 |
) |
|
|
(10,838,583 |
) |
|
|
(6,019,485 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Income (Expenses): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
1,152 |
|
|
|
449 |
|
|
|
2,162 |
|
|
|
1,735 |
|
Changes in fair value of option/warrant liabilities –
(loss)/gain |
|
|
(2,432,449 |
) |
|
|
1,830,689 |
|
|
|
(1,122,648 |
) |
|
|
(528,083 |
) |
Foreign currency exchange gains (losses) |
|
|
27,992 |
|
|
|
86,438 |
|
|
|
261,396 |
|
|
|
(109,198 |
) |
Other expenses |
|
|
(1,741 |
) |
|
|
(3,213 |
) |
|
|
(4,044 |
) |
|
|
(7,336 |
) |
Total Other Income
(Expenses) |
|
|
(2,405,046 |
) |
|
|
1,914,363 |
|
|
|
(863,134 |
) |
|
|
(642,882 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss |
|
|
(8,316,655 |
) |
|
|
(4,117,084 |
) |
|
|
(11,701,717 |
) |
|
|
(6,662,367 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Comprehensive (Loss) Income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign Currency Translation Adjustment |
|
|
(46,037 |
) |
|
|
(160,116 |
) |
|
|
(268,762 |
) |
|
|
(52,948 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive Loss |
|
$ |
(8,362,692 |
) |
|
$ |
(4,277,200 |
) |
|
$ |
(11,970,479 |
) |
|
$ |
(6,715,315 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per ordinary share (basic
and diluted) |
|
$ |
(0.00 |
) |
|
$ |
(0.00 |
) |
|
$ |
(0.00 |
) |
|
$ |
(0.01 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average ordinary
shares (basic and diluted) |
|
|
3,002,482,637 |
|
|
|
1,607,121,984 |
|
|
|
2,759,381,673 |
|
|
|
1,594,063,579 |
|
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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