Akari Therapeutics Reports Third Quarter 2020 Financial Results and Highlights Recent Clinical Progress
December 11 2020 - 9:00AM
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 third quarter ended September
30, 2020, as well as recent clinical progress.
“With the imminent opening of our Phase III trial in pediatric
patients with HSCT-TMA in Europe and a clear regulatory path in the
U.S. and Europe for our Phase III study in patients with BP, we are
now in the exciting position of progressing two Phase III programs
in orphan diseases in which there are no approved treatments,” said
Clive Richardson, Chief Executive Officer of Akari
Therapeutics.
Third Quarter 2020 and Recent Clinical
Highlights
Akari’s two lead programs – in BP and HSCT-TMA – are in Phase
III development. The Company also has programs addressing lung and
ophthalmology diseases.
Phase III clinical
trial in patients with BP
- Akari expects to initiate a pivotal
Phase III program for the treatment of BP in the first half of
2021, subject to the ongoing impact of COVID-19 related
restrictions. Following positive FDA and EMA meetings the pivotal
trial design is in two parts, with Part A and Part B having the
same structure, duration, endpoints and target population of
moderate and severe BP patients. This follows earlier positive data
from Akari’s Phase II study of nomacopan in BP patients.
- The 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
- Phase III study in pediatric
HSCT-TMA is now opening for enrollment in Europe and we plan to
open in the U.S. in the first quarter of 2021, subject to the
ongoing impact of COVID-19 related restrictions.
- Akari has both FDA
fast track for pediatric HSCT-TMA patients and orphan drug
designation status for this program.
Ophthalmology program
- Interim data from
the first-in-eye Phase I/II study in atopic keratoconjunctivitis
(AKC), a surface of the eye inflammatory disease, showed that
nomacopan was comfortable and well tolerated. Further, as
previously disclosed, enrollment into Part B of this study was
impacted by the COVID-19 pandemic. Akari has opened an
investigational new drug application (IND) and is looking to expand
its program into the broader surface of the eye market.
- The Company’s back
of the eye pre-clinical program is looking to build on the recent
American Journal of Pathology publication on uveitis. This result
has potential implications for use of nomacopan in other back of
the eye diseases such as AMD with the differentiating feature that
nomacopan can potentially treat dry AMD which is associated with
complement dysregulation while minimizing the risk of wet AMD due
to nomacopan’s VEGF inhibitory effect of LTB4.
- Given the
specialist nature of the ophthalmology market, Akari is exploring
opportunities to collaborate with potential partners to accelerate
the development of these ophthalmology programs.
Lung program
- In the UK, recruitment into the
COVID-19 observational study is complete and an initial review of
the study, which has been expanded from 50 to over 100
participants, is now expected early 2021. This observational study
will provide data on complement and cytokine activity and the
potential to optimize treatment with nomacopan by focusing on
particular patient subgroups or time points in the disease.
- In the U.S., the FDA has approved a randomized multi-center
randomized study in patients hospitalized with COVID-19 pneumonia.
Initiation of this study is expected in the first quarter of 2021.
The clinical study in Brazil has been paused to optimize dosing due
to a subset of patients whose complement levels did not remain
fully ablated, indicating an unexpectedly high complement drive as
recently reported by others (Prendecki et al 2020).
- Akari is exploring opportunities to
expand its lung program to include other inflammatory diseases with
exacerbations, limited treatment options and where both complement
and leukotriene pathways are implicated. In this context an
investigator led severe asthma study is being considered in the
US.
PNH - long term
data
- A separate press release issued today
highlights new data from 19 PNH patients treated for over 30
cumulative patient-years showing that self-administered nomacopan
is a well-tolerated and substantially reduces transfusion
dependence.
- Transfusion independence (defined as at least 6 months without
transfusion) of 79% reported for 14 PNH patients treated with
nomacopan for at least six months, who were transfusion dependent
prior to treatment.
- The long-term PNH data supports nomacopan’s therapeutic
potential in other diseases where complement dysregulation plays a
role, including Akari’s Phase III trials in BP and HSCT-TMA where
both complement (C5) and leukotriene (LTB4) are implicated.
Third Quarter
2020 Financial Results
- As of September 30, 2020, the
Company had cash of approximately $12.3 million, compared to cash
of $5.7 million as of December 31, 2019.
- 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
September 30, 2020, the initial amount of $30.0 million remained
available under the facility. Subsequent to the end of the third
quarter in October 2020, the Company sold to Aspire Capital
approximately $6.0 million of ordinary shares, which leaves $24
million of the original purchase commitment available under the
facility.
- Research and development (R&D)
income in the third quarter of 2020 was approximately $1.6 million
due to the receipt of $3.4 million in R&D tax credits. This
compares to R&D expense of approximately $1.8 million in the
same quarter the prior year.
- General and administrative
(G&A) expenses in the third quarter of 2020 were approximately
$1.8 million, as compared to approximately $1.4 million in the same
quarter last year. This increase was primarily due to higher
expenses for legal fees and insurance.
- Total other income for the third
quarter of 2020 was approximately $1.7 million, as compared to
total other income of $0.6 million in the same period the prior
year. This change of $1.1 million was primarily due to
approximately $1.0 million of gain related to the change in the
fair value of the options and warrants liabilities in the third
quarter of 2020 compared to the same period in 2019.
- Net income for the third quarter of
2020 was approximately $1.4 million, compared to a net loss of
approximately $2.6 million for the same period in 2019. The
increase in net income was primarily due to higher total other
income combined with R&D tax credits in 2020.
COVID-19 Corporate Update
Akari’s clinical trial sites are based in areas currently
affected by the global outbreak of the COVID-19 pandemic, 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 the pandemic, 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 recruitment in the Phase III
clinical trial in pediatric patients with HSCT-TMA has been and may
continue to be delayed. 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 timeframes. The extent to which the
COVID-19 pandemic 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 COVID-19 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.
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 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; 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 COVID-19
pandemic; 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, 2020 and December 31, 2019(in U.S. Dollars, except
share data)
|
|
September 30, 2020 |
|
|
December 31,2019 |
|
|
|
(Unaudited) |
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current Assets: |
|
|
|
|
|
|
|
|
Cash |
|
$ |
12,317,798 |
|
|
$ |
5,731,691 |
|
Prepaid expenses and other current assets |
|
|
1,349,244 |
|
|
|
712,975 |
|
Deferred financing costs |
|
|
- |
|
|
|
321,956 |
|
Total Current Assets |
|
|
13,667,042 |
|
|
|
6,766,622 |
|
|
|
|
|
|
|
|
|
|
Property and equipment,
net |
|
|
- |
|
|
|
5,013 |
|
Patent acquisition costs,
net |
|
|
26,674 |
|
|
|
30,163 |
|
Total Assets |
|
$ |
13,693,716 |
|
|
$ |
6,801,798 |
|
|
|
|
|
|
|
|
|
|
Liabilities and
Shareholders' Equity (Deficit) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current Liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
2,410,530 |
|
|
$ |
1,228,772 |
|
Accrued expenses |
|
|
975,893 |
|
|
|
4,228,604 |
|
Liabilities related to options and warrants |
|
|
5,448,995 |
|
|
|
3,116,880 |
|
Total Liabilities |
|
|
8,835,418 |
|
|
|
8,574,256 |
|
|
|
|
|
|
|
|
|
|
Commitments and
Contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shareholders' Equity
(Deficit): |
|
|
|
|
|
|
|
|
Share capital of £0.01 par value Authorized: 10,000,000,000
ordinaryshares; issued and outstanding: 3,386,573,113 and
2,245,865,913 at September 30, 2020 and December 31, 2019,
respectively |
|
|
46,578,543 |
|
|
|
31,987,016 |
|
Additional paid-in capital |
|
|
113,070,248 |
|
|
|
110,498,824 |
|
Accumulated other comprehensive loss |
|
|
(621,298 |
) |
|
|
(348,860 |
) |
Accumulated deficit |
|
|
(154,169,195 |
) |
|
|
(143,909,438 |
) |
Total Shareholders' Equity
(Deficit) |
|
|
4,858,298 |
|
|
|
(1,772,458 |
) |
Total Liabilities and
Shareholders' Equity (Deficit) |
|
$ |
13,693,716 |
|
|
$ |
6,801,798 |
|
|
|
|
|
|
|
|
|
|
AKARI THERAPEUTICS, Plc
CONDENSED CONSOLIDATED STATEMENTS OF
COMPREHENSIVE INCOME (LOSS) - UNAUDITEDFor the Three and Nine
Months Ended September 30, 2020 and September 30, 2019(in U.S.
Dollars)
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30,2020 |
|
|
September 30, 2019 |
|
|
September 30, 2020 |
|
|
September 30, 2019 |
|
Operating (Income)
Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development (income) expenses |
|
$ |
(1,592,531 |
) |
|
$ |
1,763,057 |
|
|
$ |
4,160,066 |
|
|
$ |
3,038,038 |
|
General and administrative expenses |
|
|
1,839,414 |
|
|
|
1,354,263 |
|
|
|
6,925,400 |
|
|
|
6,098,767 |
|
Total Operating Expenses |
|
|
246,883 |
|
|
|
3,117,320 |
|
|
|
11,085,466 |
|
|
|
9,136,805 |
|
Loss from Operations |
|
|
(246,883 |
) |
|
|
(3,117,320 |
) |
|
|
(11,085,466 |
) |
|
|
(9,136,805 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Income (Expenses): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
6,132 |
|
|
|
2,057 |
|
|
|
8,294 |
|
|
|
3,792 |
|
Changes in fair value of option/warrant liabilities – gain
(loss) |
|
|
1,532,027 |
|
|
|
515,489 |
|
|
|
409,379 |
|
|
|
(12,594 |
) |
Foreign currency exchange gains (losses) |
|
|
156,360 |
|
|
|
37,209 |
|
|
|
417,756 |
|
|
|
(71,989 |
) |
Other expenses |
|
|
(5,676 |
) |
|
|
(2,788 |
) |
|
|
(9,720 |
) |
|
|
(10,124 |
) |
Total Other Income
(Expenses) |
|
|
1,688,843 |
|
|
|
551,967 |
|
|
|
825,709 |
|
|
|
(90,915 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Income (Loss) |
|
|
1,441,960 |
|
|
|
(2,565,353 |
) |
|
|
(10,259,757 |
) |
|
|
(9,227,720 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Comprehensive (Loss) Income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign Currency Translation Adjustment |
|
|
(3,676 |
) |
|
|
3,281 |
|
|
|
(272,438 |
) |
|
|
(49,667 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive Income
(Loss) |
|
$ |
1,438,284 |
|
|
$ |
(2,562,072 |
) |
|
$ |
(10,532,195 |
) |
|
$ |
(9,277,387 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (Loss) per ordinary
share (basic and diluted) |
|
$ |
0.00 |
|
|
$ |
(0.00 |
) |
|
$ |
(0.00 |
) |
|
$ |
(0.01 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average ordinary
shares (basic and diluted) |
|
|
3,386,573,113 |
|
|
|
1,971,025,222 |
|
|
|
3,336,002,895 |
|
|
|
1,721,098,272 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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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