Akari Therapeutics Reports Third Quarter 2021 Financial Results and Highlights Recent Clinical Progress
December 03 2021 - 7:45AM
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 its financial results for the third quarter of 2021 and
recent clinical progress.
Akari’s two lead programs, in BP and pediatric HSCT-TMA, are in
Phase III clinical development and both have been granted Orphan
Drug and Fast Track designations by the U.S. Food and Drug
Administration (FDA). The Company also has earlier stage programs
addressing ophthalmology and pulmonary diseases.
“During 2021, Akari has been very active and focused on the
launch of our two orphan Phase III programs for BP and HSCT-TMA as
well as the further development of our lung and eye franchises
based on new formulations of our lead asset, nomacopan,” said Clive
Richardson, Chief Executive Officer of Akari Therapeutics. “We now
expect multiple readouts across our key ongoing and proposed
programs over the next 12-18 months.”
Clinical highlights
Phase III clinical trial in patients with bullous
pemphigoid
BP is a severe autoimmune blistering disease of the elderly with
no specific approved treatments.
- The Company has opened the first sites for its Phase III study
of nomacopan for the treatment of BP and anticipates commencing
treatment by the end of 2021.
- The FDA and the European Medicines Agency (EMA) have both
granted Orphan Drug Designation for nomacopan for the treatment of
BP, and the FDA has granted Fast Track designation to nomacopan in
BP.
- The Company is considering additional opportunities to expand
into other dermatological conditions where both complement C5
activation and LTB4 are believed to have key roles in driving the
disease pathology including hidradenitis suppurativa and other
pemphigoid diseases.
Phase III clinical trial in patients with pediatric
HSCT-TMA
HSCT-TMA is a severe disease in pediatric patients with an
approximately 80% mortality rate in patients with proteinuria and
elevated terminal complement activity. There are no approved
treatments.
- Phase III study in pediatric HSCT-TMA is now enrolling and
treating patients.
- The FDA has granted both Fast Track and Orphan Drug
Designations for nomacopan for the treatment of pediatric
HSCT-TMA.
- Success in pediatric HSCT-TMA would provide opportunities to
expand into adult HSCT-TMA and related TMA-like diseases where
complement and LTB4 are believed to have important roles such as
atypical hemolytic uremic syndrome, systemic lupus erythematosus
and anti-phospholipid syndrome.
OTHER CLINICAL PROGRAMS
Akari Therapeutics is also pursuing other earlier stage programs
that are primarily focused on large disease areas with high unmet
need and where complement and leukotriene pathways are implicated.
For these programs, the Company is using alternative formulations
to the subcutaneous delivery of nomacopan including topical,
nebulized or long-acting engineered forms, which provide an
opportunity for separate partnering options.
Ophthalmology program
- Recent publications (Eskandarpour et al 2020 and 2021) support
a potential therapeutic role for longer acting PAS-nomacopan in
sight-threatening retinal diseases given its inhibition of both
complement and vascular endothelial growth factor (VEGF) via its
inhibition of LTB4. This unique combination may be particularly
relevant to geographic atrophy (GA)/dry AMD where complement is a
key treatment target as evidenced by Phase II and III data from
Apellis and Iveric Bio, and VEGF inhibition by nomacopan may
prevent neo vascularisation, which has been seen in some GA
patients treated with other complement inhibitors.
- In order to increase the interval between intravitreal
injections into the back of the eye, the program is being advanced
with PAS-nomacopan, an engineered form of nomacopan with an
extended half-life. Data from pharmacokinetics (PK) studies with
PAS-nomacopan to estimate injection interval in the back of the eye
are expected by the end of 2021.
- Animal models described in a recent publication (1) highlight
that nomacopan eye drops reduced inflammation more than both
standard treatments, cyclosporin and the steroid dexamethasone in a
model of allergic eye disease.(1) Eskandarpour
2021, Allergy: Allergic eye disease: blocking LTB4/C5 in vivo
suppressed disease and Th2 & Th9 cells
Lung program
- An observational study sponsored by Akari in COVID-pneumonia
showed that elevated levels of C5a, C5b9 and LTB4 were present in
COVID-pneumonia patients and that the levels of C5a (p = 0.001) and
C5b9 (p=0.019), which are potential biomarkers for disease
progression, rose significantly in patients that worsened. These
findings align with a prior, separate Akari-sponsored observational
study in chronic obstructive cardiopulmonary disease (COPD)
patients that demonstrated that the level of C5a was significantly
correlated with the severity of the exacerbations (p=0.01).
- Akari is investigating the PK of inhaled nomacopan in the lung
and a proof of principle study in exacerbating COPD patients to
further evaluate the impact of inhibiting C5 and LTB4 with
nomacopan.
- The COVID-pneumonia observational findings are being further
evaluated to explore the potential role of biomarkers in
identifying the most appropriate COVID-pneumonia patients who might
respond to nomacopan.
Trauma
- The damaging role of both C5 and LTB4 has been implicated in
trauma and Akari is exploring both blast injury and hemorrhagic
shock with the United States Army Institute of Surgical Research
(USAISR) where nomacopan has been shown to improve survival in
pre-clinical studies. In addition, a separate new collaborative
study in traumatic brain injury and subarachnoid hemorrhage in man
is being initiated in the UK.
Histamine inhibitor
- Votucalis, a molecule with a similar origin to nomacopan, has a
unique mode of action by binding directly to histamine and
preventing the activation of all four histamine G-protein coupled
receptors. Ongoing work in collaboration with Durham and Newcastle
Universities is focused on expanding the Company’s existing
dermatology franchise with initial skin penetration data indicating
a potential opportunity for topical delivery.
Third Quarter 2021 Financial Results
- As of September 30, 2021, the Company had cash of approximately
$13.4 million, compared to cash of approximately $14.1 million at
December 31, 2020. 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.
- In September 2020, Akari entered into a securities purchase
agreement with Aspire Capital Fund, LLC (Aspire Capital) whereby
Aspire Capital is committed to purchase up to an aggregate of $30.0
million of the Company’s ADSs. During the nine months ended
September 30, 2021, the Company sold to Aspire Capital ordinary
shares for gross proceeds of $2.0 million. As of September 30,
2021, $22.0 million of the original purchase commitment remains
available.
- Research and development (R&D) income for the third quarter
2021 were approximately $0.4 million, as compared to approximately
$1.6 million in the same quarter the prior year. This decrease in
income was primarily due to lower R&D tax credit received for
the 2020 tax year and higher expenses incurred for clinical trials
in the third quarter 2021.
- General and administrative expenses for the third quarter 2021
were approximately $1.9 million, as compared to approximately $1.8
million in the same quarter the prior year.
- For the third quarter 2021, total other income was
approximately $12,000 as compared to total other income of
approximately $1.2 million in the third quarter of 2020. This
change was primarily due to the accounting reclassification of
warrant liabilities to shareholders’ equity as of December
2020.
- Net loss for the third quarter 2021 was approximately $1.5
million, as compared to net income of approximately $0.9 million
for the period of 2020. This decrease was primarily due to the
aforementioned lower R&D income as well as lower total other
income.
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
areas: bullous pemphigoid (BP), thrombotic microangiopathy (TMA),
as well as programs in the eye and lung.
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, 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 U.S. Food and Drug
Administration (FDA) and European Medicines Agency (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 Securities and Exchange
Commission (SEC), 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, 2021
and December 31, 2020(in U.S. dollars, except share data) |
|
|
|
|
|
|
|
|
|
September 30,2021 |
|
|
December 31,2020 |
|
|
|
(Unaudited) |
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current Assets: |
|
|
|
|
|
|
|
|
Cash |
|
$ |
13,390,989 |
|
|
$ |
14,055,777 |
|
Prepaid expenses and other current assets |
|
|
1,303,605 |
|
|
|
521,880 |
|
Total Current Assets |
|
|
14,694,594 |
|
|
|
14,577,657 |
|
|
|
|
|
|
|
|
|
|
Patent acquisition costs,
net |
|
|
23,927 |
|
|
|
27,150 |
|
Total Assets |
|
$ |
14,718,521 |
|
|
$ |
14,604,807 |
|
|
|
|
|
|
|
|
|
|
Liabilities and
Shareholders' Equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current Liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
1,923,357 |
|
|
$ |
3,380,782 |
|
Accrued expenses |
|
|
1,432,463 |
|
|
|
1,839,706 |
|
Total Liabilities |
|
|
3,355,820 |
|
|
|
5,220,488 |
|
|
|
|
|
|
|
|
|
|
Commitments and
Contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shareholders' Equity: |
|
|
|
|
|
|
|
|
Share capital of $0.0001 par value par value Authorized:
10,000,000,000 ordinary shares; issued and outstanding:
4,759,731,923 and 3,847,331,923 at September 30, 2021 and
December 31, 2020, respectively |
|
|
475,973 |
|
|
|
384,733 |
|
Additional paid-in capital |
|
|
153,057,340 |
|
|
|
139,734,651 |
|
Capital Redemption Reserve |
|
|
52,193,811 |
|
|
|
52,193,811 |
|
Accumulated other comprehensive loss |
|
|
(447,415 |
) |
|
|
(648,065 |
) |
Accumulated deficit |
|
|
(193,917,008 |
) |
|
|
(182,280,811 |
) |
Total Shareholders'
Equity |
|
|
11,362,701 |
|
|
|
9,384,319 |
|
Total Liabilities and
Shareholders' Equity |
|
$ |
14,718,521 |
|
|
$ |
14,604,807 |
|
|
|
|
|
|
|
|
|
|
|
AKARI THERAPEUTICS, Plc |
|
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS -
UNAUDITEDFor the Three and Nine Months Ended September 30, 2021 and
September 30, 2020(in U.S. dollars) |
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, 2021 |
|
|
September 30, 2020 |
|
|
September 30, 2021 |
|
|
September 30, 2020 |
|
Operating Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development (income) expenses |
|
$ |
(430,157 |
) |
|
$ |
(1,592,531 |
) |
|
$ |
5,282,576 |
|
|
$ |
4,160,066 |
|
General and administrative expenses |
|
|
1,893,559 |
|
|
|
1,839,414 |
|
|
|
6,059,497 |
|
|
|
6,925,400 |
|
Total Operating Expenses |
|
|
1,463,402 |
|
|
|
246,883 |
|
|
|
11,342,073 |
|
|
|
11,085,466 |
|
Loss from Operations |
|
|
(1,463,402 |
) |
|
|
(246,883 |
) |
|
|
(11,342,073 |
) |
|
|
(11,085,466 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Income (Expenses): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
1,371 |
|
|
|
6,132 |
|
|
|
6,621 |
|
|
|
8,294 |
|
Changes in fair value of warrant liabilities – gain |
|
|
- |
|
|
|
1,003,521 |
|
|
|
- |
|
|
|
397,368 |
|
Foreign currency exchange gains (losses) |
|
|
14,224 |
|
|
|
156,360 |
|
|
|
(284,384 |
) |
|
|
417,756 |
|
Other expenses |
|
|
(3,554 |
) |
|
|
(5,676 |
) |
|
|
(16,361 |
) |
|
|
(9,720 |
) |
Total Other Income
(expenses) |
|
|
12,041 |
|
|
|
1,160,337 |
|
|
|
(294,124 |
) |
|
|
813,698 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss (income) |
|
|
(1,451,361 |
) |
|
|
913,454 |
|
|
|
(11,636,197 |
) |
|
|
(10,271,768 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Comprehensive (Loss) Income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign Currency Translation Adjustment |
|
|
(27,329 |
) |
|
|
(3,676 |
) |
|
|
200,650 |
|
|
|
(272,438 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive Loss
(income) |
|
$ |
(1,478,690 |
) |
|
$ |
909,778 |
|
|
$ |
(11,435,547 |
) |
|
$ |
(10,544,206 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per ordinary share (basic
and diluted) |
|
$ |
(0.00 |
) |
|
$ |
(0.00 |
) |
|
$ |
(0.00 |
) |
|
$ |
(0.00 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average ordinary
shares (basic and diluted) |
|
|
4,645,842,719 |
|
|
|
3,386,573,113 |
|
|
|
4,134,526,690 |
|
|
|
3,336,002,895 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For more information
Investor Contact:Peter VozzoICR Westwicke(443)
213-0505peter.vozzo@westwicke.com
Media Contact:Sukaina Virji / Maya
BennisonConsilium Strategic Communications+44 (0)20 3709
5700Akari@consilium-comms.com
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