Akari Therapeutics Reports Full Year 2021 Financial Results and Highlights Clinical Progress
May 16 2022 - 6:00AM
Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology
company focused on advanced therapies for autoimmune and
inflammatory diseases, today announced financial results for the
full year ended December 31, 2021, as well as recent pipeline
progress.
“During the last twelve months, Akari has advanced nomacopan
pre-clinical and clinical development programs, including three
focus areas of autoimmune skin diseases, thrombotic
microangiopathies, and progressive retinal diseases,” said Rachelle
Jacques, President and CEO of Akari Therapeutics. “Broad and deep
research and development work is producing compelling science in
diseases with complex pathologies and is providing the foundation
for next steps in the development of bispecific recombinant
nomacopan. Late-stage programs in pediatric HSCT-TMA and BP are
active and advancing in Part A clinical studies, which will inform
the pivotal Part B studies that will be the basis for potential
regulatory submissions in the U.S. and Europe.”
Full Year 2021 and Recent Clinical Highlights
Late-Stage Program Studying Investigational Nomacopan in
Pediatric HSCT-TMA
- Phase III Part A clinical trial sites are open and recruiting
in the U.S. and Europe for investigation of nomacopan in pediatric
HSCT-TMA.
- Urgent unmet need exists in pediatric HSCT-TMA with no approved
treatment options in the U.S. or Europe; currently the subset of
patients Akari is studying are facing a mortality rate of ~80%
- Nomacopan was granted Orphan Drug and Fast Track designations
from the U.S. Food and Drug Administration (FDA) for pediatric
HSCT-TMA
- Patient dosing is underway in the Part A study that has a
recruitment goal of approximately seven patients, with a minimum of
two patients in each of three age cohorts
Late-Stage Program Studying Investigational Nomacopan in Bullous
Pemphigoid (BP)
- FDA and European Medicines Agency (EMA) registration-directed
Phase III Part A study of nomacopan in moderate and severe BP
patients is open for enrollment following resolution of third-party
supply chain partner issues that resulted in delays. Data from the
Part A study will inform the pivotal Part B study that will be the
basis for potential regulatory submissions in the U.S. and Europe
- There are no approved therapies; superpotent topical steroid
and high dose oral corticosteroid (OCS) are the current standards
of care
- The mortality rate in BP is approximately three-fold higher
than the general population due to the disease itself, and
infections and cardiovascular conditions that are more common in
older patients and are exacerbated by treatment with high dose
OCS.1
- There is significant unmet need for an effective
steroid-sparing therapy.
- Nomacopan was granted Orphan Drug and Fast Track designations
by the FDA and Orphan Drug designation from the EMA for the
treatment of BP
- Results from the completed Phase II study of subcutaneous
nomacopan in patients with mild to moderate BP were published
online in JAMA Dermatology in May 2022
- The Phase II study advanced understanding of the nomacopan
safety profile and informed duration of treatment in the ARREST-BP
Phase III Part A clinical trial, which is currently open for
enrollment
- The multi-center, single arm nonrandomized controlled Phase II
study included nine patients newly diagnosed or recurrent patients
with mild to moderate active BP
- Patients received subcutaneous nomacopan (30 mg once daily)
with lesional mometasone from Day 1 to 21 of treatment and
nomacopan only from Day 21 to Day 42
- Seven of nine patients responded to nomacopan with three,
regarded as complete responders, showing >80% reduction in BPDAI
(BP disease activity index) activity and four patients showing
>70% reduction in pruritis by Day 42; two of nine patients were
non-responders
- None of the nine patients reported Common Terminology Criteria
for Adverse Events (CTCAE) grade three, four or five
treatment-related adverse events
- A poster outlining the design of the Phase III study of
nomacopan in patients with moderate to severe BP was presented at
the 2021 International Pemphigus & Pemphigoid Foundation (IPPF)
Scientific Symposium
Pre-Clinical Program Studying Investigational Long-Acting
PAS-Nomacopan for Geographic Atrophy/Dry Age-Related Macular
Degeneration (GA/dAMD)
- Akari has conducted pre-clinical studies that explore the
importance of the leukotriene B4 (LTB4)-VEGF axis and the potential
role of nomacopan’s bispecific inhibition of both C5 and LTB4 in
treating GA/dAMD
- Studies have indicated that while certain complement inhibitors
slow the progression of GA, they may also promote choroidal
neovascularization (CNV), which can harm the macula, damage
vision,2,3 and require VEGF rescue therapy
- LTB4 is a potent leukotactic agent that can increase retinal
vascular endothelial growth factor (VEGF) a key driver of CNV.
Inhibition of LTB4 may decrease the risk of CNV.4
- Akari has conducted pre-clinical studies that explore the
importance of the LTB4-VEGF axis and the potential role of
nomacopan’s bispecific inhibition of both C5 and LTB4 in treating
GA/dAMD
- In a non-infectious allergic uveitis animal model,
PAS-nomacopan reduced VEGF by more than 50% compared to saline
control, equivalent to the inhibition caused by an anti-VEGF
antibody. In addition, PAS-nomacopan was significantly more
effective in reducing retinal inflammation than the anti-VEGF
antibody.
- A pre-clinical study presented at ARVO 2022 used an industry
standard model of laser induced CNV. Intravitreal (IVT)
PAS-nomacopan injected once during a 16-day treatment period was
compared to an FDA-approved VEGF inhibitor for impact on
neovascularization. The IVT single dose of PAS-nomacopan
significantly reduced CNV (p=0.022) as compared to saline and was
as effective as multiple IVT injections of the VEGF inhibitor
(p=0.019.) Single IVT injection of PAS-nomacopan showed a trend
towards reduced leakage on Day 14 (p = 0.097).
- Currently approved therapies for retinal diseases injected
directly into the vitreous cavity are typically administered
monthly. Studies have shown that due to adverse effects (such as an
increase in intraocular pressure [IOP]), discomfort and anxiety,
IVT injection presents a heavy burden on patients
- PASylation of nomacopan has the potential to make it
long-lasting in the back of the eye and may provide a dosing
interval that is more attractive to patients
- Akari is continuing pharmacokinetic (PK) and pharmacodynamic
(PD) work to optimize PAS-nomacopan with the aim of achieving
safety and efficacy in GA, and meeting patient preferences for less
frequent injections
Studies of Investigational Nomacopan in Inflammation-Implicated
Lung Conditions
- Advanced the study of investigational nomacopan in the
treatment of inflammation-implicated lung conditions
- The CORONET study evaluated compassionate use of
investigational nomacopan in the treatment of hospitalized COVID-19
pneumonia patients in the U.S.
- The CASCADE study in the U.K. explored correlations between
biomarkers and risk stratification categories to help predict the
subsets of COVID-19 pneumonia patients who have a higher propensity
to deteriorate clinically to more severe disease
Nomacopan Manufacturing
- Significantly
increased the total yield of nomacopan (more than five-fold) with a
new manufacturing process
References:
- Tedbirt B, et al.,
JAMA Dermatol. 2021 Apr 1;157(4)
- Liao DS, et al. Ophthalmology. 2020 Feb;127(2)
- Jaffe GJ et al. Ophthalmology. 2021 Apr;128(4)
- Sasaki F et al. JCI Insight. 2018 Sep 20;3(18)
Full Year 2021 Financial Results
- At December 31, 2021, the Company had cash of approximately
$9.4 million, compared to cash of approximately $14.1 million at
December 31, 2020.
- In March 2022, Akari entered into an agreement with Paulson
Investment Company, LLC to serve as placement agent in connection
with a registered direct offering and sold approximately 7.4
million of the Company’s ADSs for gross proceeds of approximately
$8.9 million.
- In December 2021, Akari entered into an agreement with Paulson
Investment Company, LLC to serve as placement agent in connection
with a registered direct offering and sold approximately 4.3
million of the Company’s ADSs for gross proceeds of approximately
$6.0 million.
- In July 2021, Akari closed a private placement of approximately
$12.3 million in gross proceeds by issuing approximately 7.9
million of the Company’s ADSs.
- Research and development (R&D) expenses for full year 2021
were approximately $9.1 million, as compared to approximately $8.8
million for full year 2020.
- General and administrative expenses for full year 2021 were
approximately $8.1 million, as compared to approximately $9.2
million for full year 2020. This decrease was primarily due to a
one-time non-cash financing expense of approximately $900,000 in
2020 related to the 2020 Purchase Agreement with Aspire
Capital.
- For full year 2021, total other loss was approximately $210,000
as compared to total other income of approximately $899,000 for
full year 2020. This change was primarily due to the accounting
reclassification of warrant liabilities to shareholders’ equity as
of December 2020.
- Net loss for the full year 2021 was approximately $17.4
million, as compared to net loss of approximately $17.1 million for
full year 2020.
A copy of the Company’s Annual Report on Form 20-F for the year
ended December 31, 2021 will be filed with the Securities and
Exchange Commission and posted on the Company’s website at
http://investor.akaritx.com/financial-information/sec-filings
About Akari TherapeuticsAkari Therapeutics, plc
(Nasdaq: AKTX) is a biotechnology company focused on developing
advanced therapies for autoimmune and inflammatory diseases.
Akari's lead asset, investigational nomacopan, is a bispecific
recombinant inhibitor of C5 complement activation and leukotriene
B4 (LTB4) activity. The Akari pipeline includes two late-stage
programs for bullous pemphigoid (BP) and thrombotic microangiopathy
(TMA), as well as earlier stage research and development programs
in eye and lung diseases with significant unmet need. For more
information about Akari, please visit akaritx.com.
Cautionary Note Regarding Forward-Looking
StatementsCertain 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, 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 there; 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 impact of
the COVID-19 pandemic; 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.
Consolidated Statements
AKARI THERAPEUTICS, Plc
CONSOLIDATED BALANCE SHEETSAs of December 31,
2021 and 2020(in U.S. Dollars, except share data)
|
|
|
|
|
|
|
|
|
December 31, |
|
December 31, |
|
|
2021 |
|
2020 |
Assets |
|
|
|
|
|
|
Current Assets: |
|
|
|
|
|
|
Cash |
|
$ |
9,361,270 |
|
|
$ |
14,055,777 |
|
Prepaid expenses |
|
|
2,173,528 |
|
|
|
292,680 |
|
Other current assets |
|
|
90,301 |
|
|
|
229,200 |
|
Total Current Assets |
|
|
11,625,099 |
|
|
|
14,577,657 |
|
|
|
|
|
|
|
|
Patent acquisition costs, net |
|
|
22,929 |
|
|
|
27,150 |
|
Total Assets |
|
$ |
11,648,028 |
|
|
$ |
14,604,807 |
|
|
|
|
|
|
|
|
Liabilities and Shareholders' Equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
Current Liabilities: |
|
|
|
|
|
|
Accounts payable |
|
|
1,788,563 |
|
|
|
3,380,782 |
|
Accrued expenses |
|
|
3,184,883 |
|
|
|
1,839,706 |
|
Liability related to deposits received for share subscriptions |
|
|
1,120,000 |
|
|
|
— |
|
Total Liabilities |
|
$ |
6,093,446 |
|
|
$ |
5,220,488 |
|
|
|
|
|
|
|
|
Commitments and Contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
Shareholders' Equity: |
|
|
|
|
|
|
Share capital of $0.0001 par value |
|
|
|
|
|
|
Authorized: 15,000,000,000 ordinary shares; issued and outstanding:
4,759,731,923 and 3,847,331,923 at December 31, 2021 and December
31, 2020, respectively |
|
|
475,973 |
|
|
|
384,733 |
|
Additional paid-in capital |
|
|
153,130,813 |
|
|
|
139,734,651 |
|
Capital redemption reserve |
|
|
52,193,811 |
|
|
|
52,193,811 |
|
Accumulated other comprehensive loss |
|
|
(540,967 |
) |
|
|
(648,065 |
) |
Accumulated deficit |
|
|
(199,705,048 |
) |
|
|
(182,280,811 |
) |
Total Shareholders' Equity |
|
|
5,554,582 |
|
|
|
9,384,319 |
|
Total Liabilities and Shareholders' Equity |
|
$ |
11,648,028 |
|
|
$ |
14,604,807 |
|
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSSFor
the Years Ended December 31, 2021, 2020 and 2019(in U.S.
Dollars, except share data
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31, |
|
|
2021 |
|
|
2020 |
|
|
2019 |
|
Operating Expenses: |
|
|
|
|
|
|
|
|
|
Research and development expenses |
|
$ |
9,133,455 |
|
|
$ |
8,820,204 |
|
|
$ |
8,739,420 |
|
General and administrative expenses |
|
|
8,080,681 |
|
|
|
9,160,770 |
|
|
|
8,223,700 |
|
|
|
|
|
|
|
|
|
|
|
Total Operating Expenses |
|
|
17,214,136 |
|
|
|
17,980,974 |
|
|
|
16,963,120 |
|
Loss from Operations |
|
|
(17,214,136 |
) |
|
|
(17,980,974 |
) |
|
|
(16,963,120 |
) |
Other Income: |
|
|
|
|
|
|
|
|
|
Interest income |
|
|
10,600 |
|
|
|
13,615 |
|
|
|
5,531 |
|
Changes in fair value of warrant liabilities - gain |
|
|
— |
|
|
|
556,810 |
|
|
|
198,948 |
|
Foreign currency exchange losses |
|
|
(193,219 |
) |
|
|
(350,939 |
) |
|
|
(67,256 |
) |
Other expenses |
|
|
(27,482 |
) |
|
|
(22,007 |
) |
|
|
(20,306 |
) |
Total Other (Loss) Income |
|
|
(210,101 |
) |
|
|
899,357 |
|
|
|
116,917 |
|
Net Loss |
|
|
(17,424,237 |
) |
|
|
(17,081,617 |
) |
|
|
(16,846,203 |
) |
Other Comprehensive Income: |
|
|
|
|
|
|
|
|
|
Foreign Currency Translation Adjustment |
|
|
107,098 |
|
|
|
(299,205 |
) |
|
|
3,566 |
|
Comprehensive Loss |
|
$ |
(17,317,139 |
) |
|
$ |
(17,380,822 |
) |
|
$ |
(16,842,637 |
) |
Loss per ordinary share (basic
and diluted) |
|
$ |
(0.00 |
) |
|
$ |
(0.01 |
) |
|
$ |
(0.01 |
) |
Weighted average ordinary
shares (basic and diluted) |
|
|
4,292,112,667 |
|
|
|
3,159,037,588 |
|
|
|
1,830,998,609 |
|
For more information
Investor Contact:Peter VozzoICR Westwicke(443)
213-0505peter.vozzo@westwicke.com
Media Contact:Sukaina Virji/ Maya BennisonConsilium Strategic
CommunicationsAkari@consilium-comms.com
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