16.05.2024 14:00:08 - dpa-AFX: GNW-Adhoc: Akari Therapeutics Reports First Quarter 2024 Financial Results and Recent Highlights

Entered into a Definitive Merger Agreement with Peak Bio; Expected to Close in
                           the Third Quarter of 2024
                   Samir R. Patel, M.D. Appointed Interim CEO

Plan for Prioritization of Peak Bio's ADC Cancer Therapeutic Platform Technology
               and Akari's PAS-nomacopan for Geographic Atrophy
        Implementation of Restructuring Plan to Reduce Operating Costs

Existing Investors Support the Company with Issuance of $1 million in Unsecured
Convertible Notes
BOSTON and LONDON, May 16, 2024 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc
(Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies
for autoimmune and inflammatory diseases, has reported financial results for the
first quarter ended March 31, 2024 as well as recent company highlights.
"My first few weeks as Interim CEO of Akari have been filled with non-stop
activity and optimism," said Samir R. Patel, MD, Akari Interim President and
CEO. "We continue to work towards completion of the merger with Peak Bio,
advance PAS-nomacopan in geographic atrophy, and explore value creation through
business opportunities with nomacopan, a phase 3 ready compound. In addition,
we continue to be incredibly optimistic about the potential opportunities
afforded by Peak's ADC platform technology."
Recent Company Highlights
  * Entered into a definitive agreement with Peak Bio Inc. (Peak Bio) to merge
    as equals in an all-stock transaction. The combined entity will operate as
    Akari Therapeutics, Plc, which is expected to continue to be listed and
    trade on the Nasdaq Capital Market as AKTX. The merger is expected to close
    in the third quarter of 2024.
  * Announced portfolio prioritization plan for combined go-forward company

which will focus on Peak's antibody drug conjugate (ADC) platform technology
    and Akari's PAS-nomacopan Geographic Atrophy (GA) program. As a result of
    this prioritization, the Company's HSCT-TMA program was suspended.
  * Announced key leadership changes, including the appointment of experienced
    life sciences entrepreneur Samir R. Patel, M.D. as interim CEO, following
    the departure of Rachelle Jacques.

* Commenced implementation of a reduction-in-force of approximately 67% of the
    Company's total workforce as part of an operational restructuring plan,
    which included the elimination of certain senior management positions, to
    reduce operating costs while supporting the Company's long-term strategic
    plan.
  * In May 2024, issued unsecured convertible, short-term promissory notes to
    Samir R. Patel, M.D, the Company's President and Chief Executive Officer,

and Ray Prudo, M.D., the Company's Chairman of the Board, each in the amount of $500,000 to provide operating capital.
First Quarter 2024 Financial Results
As of March 31, 2024, the Company had cash of approximately $1.3 million.
Research and development expenses were approximately $2.3 million for the three
months ended March 31, 2024, as compared to approximately $1.7 million for the
same period in 2023.
General and administrative expenses were approximately $3.7 million for the
three months ended March 31, 2024, as compared to approximately $2.9 million for
the same period in 2023.
Total other income, net was approximately $0.4 million for the three months
ended March 31, 2024, as compared to approximately $5.6 million for the same
period in 2023, of which $0.6 million and $5.6 million was the result of net
non-cash gains related to the company's liability-classified warrants issued in
connection with the company's September 2022 private placement transaction.
Net loss was approximately $5.6 million for the three months ended March
31, 2024, as compared to net income of approximately $1.0 million for the same
period in 2023. Excluding the non-cash gains of approximately $0.6 million and
$5.6 million for the three months ended March 31, 2024 and 2023, respectively,
related to the company's liability-classified warrants, net loss was $6.2
million and $4.6 million, respectively.
Readers are referred to, and encouraged to read in its entirety, the company's
Quarterly Report on Form 10-Q for the three months ended March 31, 2024, as
filed with the Securities and Exchange Commission on March 15, 2024, which
includes further detail on the Company's business plans, operations, financial
condition, and results of operations.
About the Merger
On March 5, 2024, Akari and Peak Bio announced a definitive agreement to merge
as equals in an all-stock transaction. The combined entity will operate as Akari
Therapeutics, Plc, which is expected to continue to be listed and trade on the
Nasdaq Capital Market as AKTX, under the Chairmanship of Hoyoung Huh, MD, PhD.
Under the terms of the agreement, Peak stockholders will receive a number of
Akari ordinary shares (represented by American Depositary Shares) for each share
of Peak stock they own, as determined on the basis of the exchange ratio
described in the agreement. The exchange is expected to result in implied equity
ownership in the combined company of approximately 50% for Akari shareholders
and approximately 50% for Peak stockholders on a fully diluted basis, subject to
adjustment under certain circumstances, including based on each party's relative
level of net cash at the closing of the proposed transaction. The transaction is
expected to close by the third quarter of this year subject to the satisfaction
of customary closing conditions, including approval by the shareholders of both
companies.
About Akari Therapeutics
Akari Therapeutics, plc (Nasdaq: AKTX) is a biotechnology company developing
advanced therapies for autoimmune and inflammatory diseases. Akari's lead asset,
investigational nomacopan, is a bispecific recombinant inhibitor of complement
C5 activation and leukotriene B4 (LTB4) activity. The company is conducting pre-
clinical research of long-acting PAS-nomacopan in geographic atrophy (GA). For
more information about Akari, please visit akaritx.com.
Cautionary Note Regarding Forward-Looking Statements
This communication includes express or implied forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange
Act"), about the proposed transaction between Peak Bio and Akari and the
operations of the combined company that involve risks and uncertainties relating
to future events and the future performance of Akari and Peak Bio. Actual events
or results may differ materially from these forward-looking statements. Words
such as "will," "could," "would," "should," "expect," "plan," "anticipate,"
"intend," "believe," "estimate," "predict," "project," "potential," "continue,"
"future," "opportunity" "will likely result," "target," variations of such
words, and similar expressions or negatives of these words are intended to
identify such forward-looking statements, although not all forward-looking
statements contain these identifying words. Examples of such forward-looking
statements include, but are not limited to, express or implied statements
regarding: the business combination and related matters, including, but not
limited to, satisfaction of closing conditions to the proposed transaction,
prospective performance and opportunities with respect to Akari or Peak Bio,
post-closing operations and the outlook for the companies' businesses; Akari's,
Peak Bio's or the combined company's targets, plans, objectives or goals for
future operations, including those related to Akari's and Peak Bio's product
candidates, research and development, product candidate introductions and
product candidate approvals as well as cooperation in relation thereto;
projections of or targets for revenues, costs, income (or loss), earnings per
share, capital expenditures, dividends, capital structure, net financials and
other financial measures; future economic performance, future actions and
outcome of contingencies such as legal proceedings; and the assumptions
underlying or relating to such statements.
These statements are based on Akari's current plans, estimates and projections.
By their very nature, forward-looking statements involve inherent risks and
uncertainties, both general and specific. A number of important factors,
including those described in this communication, could cause actual results to
differ materially from those contemplated in any forward-looking statements.
Factors that may affect future results and may cause these forward-looking
statements to be inaccurate include, without limitation: uncertainties as to the
timing for completion of the proposed transaction; uncertainties as to Peak
Bio's and/or Akari's ability to obtain the approval of Akari's shareholders or
Peak Bio's stockholders required to consummate the proposed transaction? the
possibility that competing offers will be made by third parties? the occurrence
of events that may give rise to a right of one or both of Akari and Peak Bio to
terminate the merger agreement; the possibility that various closing conditions
for the proposed transaction may not be satisfied or waived on a timely basis or
at all, including the possibility that a governmental entity may prohibit,
delay, or refuse to grant approval, if required, for the consummation of the
proposed transaction (or only grant approval subject to adverse conditions or
limitations); the difficulty of predicting the timing or outcome of consents or
regulatory approvals or actions, if any; the possibility that the proposed
transaction may not be completed in the time frame expected, or at all; the risk
that Akari may not realize the anticipated benefits of the proposed transaction
in the time frame expected, or at all; the effects of the proposed transaction
on relationships with Akari's or Peak Bio's employees, business or collaboration
partners or governmental entities; the ability to retain and hire key personnel;
potential adverse reactions or changes to business relationships resulting from
the announcement or completion of the proposed transaction; significant or
unexpected costs, charges or expenses resulting from the proposed transaction;
the potential impact of unforeseen liabilities, future capital expenditures,
revenues, costs, expenses, earnings, synergies, economic performance,
indebtedness, financial condition and losses on the future prospects, business
and management strategies for the management, expansion and growth of the
combined business after the consummation of the proposed transaction; potential
negative effects related to this announcement or the consummation of the
proposed transaction on the market price of Akari's American Depositary Shares
and Akari's operating or financial results; uncertainties as to the long-term
value of Akari's American Depositary Shares (and the ordinary shares represented
thereby), including the dilution caused by Akari's issuance of additional
American Depositary Shares (and the ordinary shares represented thereby) in
connection with the proposed transaction; unknown liabilities related to Akari
or Peak Bio; the nature, cost and outcome of any litigation and other legal
proceedings involving Akari, Peak Bio or their respective directors, including
any legal proceedings related to the proposed transaction; risks related to
global as well as local political and economic conditions, including interest
rate and currency exchange rate fluctuations; potential delays or failures
related to research and/or development of Akari's programs or product
candidates; risks related to any loss of Akari's patents or other intellectual
property rights; any interruptions of the supply chain for raw materials or
manufacturing for Akari product candidates, the nature, timing, cost and
possible success and therapeutic applications of product candidates being
developed by Akari, or its collaborators or licensees; the extent to which the
results from the research and development programs conducted by Akari, Peak Bio,
and/or their respective collaborators or licensees may be replicated in other
studies and/or lead to advancement of product candidates to clinical trials,
therapeutic applications, or regulatory approval; uncertainty of the
utilization, market acceptance, and commercial success of Akari's product
candidates, and the impact of studies (whether conducted by Akari or others and
whether mandated or voluntary) on any of the foregoing; unexpected breaches or
terminations with respect to Akari's material contracts or arrangements; risks
related to competition for Akari's product candidates; Akari's ability to
successfully develop or commercialize Akari's product candidates; Akari's, or
its collaborators' abilities to continue to conduct current and future
developmental, preclinical and clinical programs; potential exposure to legal
proceedings and investigations; risks related to changes in governmental laws
and related interpretation thereof, including on reimbursement, intellectual
property protection and regulatory controls on testing, approval, manufacturing,
development or commercialization of any of Akari's product candidates;
unexpected increase in costs and expenses with respect to the potential
transaction or Akari's business or operations; and risks and uncertainties
related to epidemics, pandemics or other public health crises and their impact
on Akari's business, operations, supply chain, patient enrollment and retention,
preclinical and clinical trials, strategy, goals and anticipated milestones.
While the foregoing list of factors presented here is considered representative,
no list should be considered to be a complete statement of all potential risks
and uncertainties. There can be no assurance that the proposed transaction or
any other transaction described above will in fact be consummated in the manner
described or at all. A more complete description of these and other material
risks can be found in Akari's filings with the U.S. Securities and Exchange
Commission (the "SEC"), including Akari's Annual Report on 10-K, for the year
ended December 31, 2023, subsequent periodic reports, and other documents that
may be filed from time to time with the SEC. These risks, as well as other risks
associated with the proposed transaction, will be more fully discussed in the
joint proxy statement/prospectus that will be included in the registration
statement on Form S-4 that will be filed with the SEC in connection with the
proposed transaction, which joint proxy statement/prospectus will be mailed or
otherwise disseminated to Akari's shareholders when it becomes available.
Any forward-looking statements speak only as of the date of this communication
and are made based on the current beliefs and judgments of Akari's management,
and the reader is cautioned not to rely on any forward-looking statements made
by Akari. Unless required by law, Akari is under no duty and undertakes no
obligation to update or revise any forward-looking statement after the
distribution of this document, including without limitation any financial
projection or guidance, whether as a result of new information, future events or
otherwise.
No Offer or Solicitation
This communication is not intended to and shall not constitute an offer to
subscribe for, buy or sell or the solicitation of an offer to subscribe for, buy
or sell any securities, or a solicitation of any vote or approval, nor shall
there be any sale of, or offer to sell or buy, securities in any jurisdiction in
which such offer, solicitation or sale would be unlawful prior to registration
or qualification under the securities laws of any such jurisdiction. This
communication is for informational purposes only. No offering of securities
shall be made, except by means of a prospectus meeting the requirements of
Section 10 of the U.S. Securities Act of 1933, as amended, and otherwise in
accordance with applicable law.
Additional Information and Where to Find It
In connection with the proposed transaction, Akari and Peak Bio expect to file
with the SEC a Registration Statement on Form S-4. The Registration Statement on
Form S-4 will include a prospectus of Akari and a joint proxy statement of Akari
and Peak Bio, and each party may also file other documents regarding the
proposed transaction with the SEC. INVESTORS AND SECURITY HOLDERS ARE URGED TO
READ CAREFULLY THE REGISTRATION STATEMENT ON FORM S-4, JOINT PROXY STATEMENT/
PROSPECTUS AND OTHER RELEVANT DOCUMENTS FILED OR WILL BE FILED WITH THE SEC, AS
WELL AS ANY AMENDMENTS OR SUPPLEMENTS THERETO AND ANY DOCUMENTS INCORPORATED BY
REFERENCE THEREIN, IN THEIR ENTIRETY IF AND WHEN THEY BECOME AVAILABLE BECAUSE
THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED
TRANSACTION, RELATED MATTERS AND THE PARTIES TO THE PROPOSED TRANSACTION.
You may obtain a free copy of the Registration Statement on Form S-4, joint
proxy statement/prospectus and other relevant documents (if and when they become
available) that are or will be filed with the SEC for free at the SEC's website
at www.sec.gov. Copies of the documents filed with the SEC by Akari will be
available free of charge on Akari's website at http://investor.akaritx.com/ or
by contacting Akari's Investor Relations Department at
http://investor.akaritx.com/investor-resources/contact-us. Copies of the
documents filed with the SEC by Peak Bio will be available free of charge on
Peak Bio's website at https://peak-bio.com/investors or by contacting Peak Bio's
Investor Relations Department at https://peak-bio.com/contact.
Participants in the Solicitation
Akari, Peak Bio and their respective directors and executive officers and other
members of management and employees may be deemed to be participants in the
solicitation of proxies in respect of the proposed transaction. Information
about the directors and executive officers of Akari, including a description of
their direct or indirect interests, by security holdings or otherwise, is set
forth in Akari's Annual Report on Form 10-K for the year ended December
31, 2023 filed with the SEC on March 29, 2024, subsequent quarterly and current
reports on Form 10-Q and -K, respectively, and other documents that may be filed
from time to time with the SEC. Information about the directors and executive
officers of Peak Bio, including a description of their direct or indirect
interests, by security holdings or otherwise, is set forth in Peak Bio's proxy
statement for its 2022 Special Meeting of Stockholders, which was filed with the
SEC on October 19, 2022, the Annual Report on Form 10-K for the year ended
December 31, 2022 filed with the SEC on June 29, 2023, subsequent quarterly and
current reports on Form 10-Q and Form 8-K, respectively, and other documents
that may be filed from time to time with the SEC. Other information regarding
the participants in the proxy solicitations and a description of their direct
and indirect interests, by security holdings or otherwise, will be contained in
the joint proxy statement/prospectus included in the Registration Statement on
Form S-4 and other relevant materials to be filed with the SEC regarding the
proposed transaction when such materials become available. Security holders,
potential investors and other readers should read the joint proxy
statement/prospectus, included in the Registration Statement on Form S-4
carefully when it becomes available before making any voting or investment
decision. You may obtain free copies of these documents from Akari or Peak Bio
using the sources indicated above.
For more information
Investor Contact:
Mike Moyer
LifeSci Advisors
(617) 308-4306
mmoyer@lifesciadvisors.com
Akari Therapeutics Plc
Condensed Consolidated Statements of Operations and Comprehensive Loss (Income)
(Unaudited, in U.S. dollars)
                                                  Three Months Ended
                                                      March 31,
                                        --------------------------------------

(in thousands, except per share
 amounts)                                      2024                2023
--------------------------------------- ------------------   -----------------

Operating expenses:
 Research and development                $          2,279     $         1,731
 General and administrative                         3,710               2,863
                                        ------------------   -----------------
 Loss from operations                              (5,989 )            (4,594 )

Other income (expense):
Change in fair value of warrant
 liability                                            649               5,587
 Other (expense) income, net                         (226 )                 8
                                        ------------------   -----------------
 Net (loss) income                       $         (5,566 )   $         1,001
                                        ------------------   -----------------
 Net (loss) income per ordinary share    $                )   $
 - basic and diluted                                (0.00                0.00
                                        ------------------   -----------------

Weighted-average number of ordinary
shares used in computing net (loss)
income per share
 - Basic                                   13,453,147,979       7,474,546,753
                                        ------------------   -----------------
 - Diluted                                 13,453,147,979       7,573,542,457
                                        ------------------   -----------------

Akari Therapeutics Plc
Condensed Consolidated Balance Sheet Data
(Unaudited, in U.S. dollars)
                                                March        December
                                                 31,           31,
 ($'s in thousands)                              2024          2023
--------------------------------------------- ----------   ------------
 Cash                                          $  1,310     $    3,845
 Other assets                                     1,462            510
                                              ----------   ------------
 Total assets                                  $  2,772     $    4,355
                                              ----------   ------------
 Total liabilities                             $  6,325     $    4,584
 Total shareholders' deficit                     (3,553 )         (229 )
                                              ----------   ------------
 Total liabilities and shareholders' deficit   $  2,772     $    4,355

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