BOSTON and LONDON, April 1, 2024 (Globe Newswire) — Akari Therapeutics, Inc. (NASDAQ: AKTX), a late-stage biotechnology company developing advanced treatments for autoimmune and inflammatory diseases, We also reported financial results for the full year 2023. As a recent company highlight.
“Amid challenging economic conditions in the biotech space and beyond in 2023, the Akari team advanced its Phase 3 and preclinical development programs, paving the way for the merger.The merger will expand the pipeline after closure. and opens the door to new possibilities for growth and value creation,'' said Rachelle Jacques, President and CEO of Akari. “We believe we are building strong momentum and are excited about the opportunities that exist in the combined company.”
Company highlights
Akari announced that it has reached a definitive agreement to merge with Peak Bio Inc. (Peak Bio) in an all-stock transaction of equals. The combined entity will operate as Akari Therapeutics, Plc and will continue to be listed and traded on the Nasdaq Capital Market as AKTX.
Following the completion of the acquisition, the company will continue to develop multiple attractive products across early and late stages of development, including a robust antibody-drug conjugate (ADC) toolkit with novel payload and linker technology, and a Phase 2-ready neutrophil elastase inhibitor (NEI). will have an expanded pipeline of assets. ) Nomacopan, a bispecific inhibitor of two immune pathways (complement C5 and leukotriene B4/LTB4), alpha-1 antitrypsin in phase 3 development for pediatric hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) Long-acting PAS-Nomacopan for Geographic Atrophy (GA), a program targeting the disease (AATD).
A strategic assessment of the pipeline is planned to evaluate the development of the four programs, including program prioritization, updated timelines, near-term value creation opportunities, and other considerations. The evaluation is expected to be completed prior to the closing of the merger.
The Phase 3 Part A clinical trial of investigational Nomacopan in pediatric HSCT-TMA is being studied in multiple age groups with an emphasis on PK/PD and dose confirmation. Akari continues to recruit patients for Part A of the Phase 3 clinical trial, in which he has treated 10 patients to date. Enrollment in Part A will be based on new consensus criteria published in 2023 that support early screening and diagnosis of high-risk (severe) patients with HSCT-TMA. The Phase 3 clinical trial will also include a Part B portion focused on safety and efficacy. The Part B study initiation plan will be determined based on a strategic pipeline assessment.
HSCT-TMA is a rare complication of stem cell transplantation, with no approved treatment options and a mortality rate of 80% in critically ill patients. Nomacopan is being developed as potentially the first approved treatment for this condition.
Akali has received Orphan Drug Designation from the European Commission for the treatment of hematopoietic stem cell transplantation, and FDA Orphan Drug, Fast Track and Rare Pediatric Disease designations for Nomacopan for the treatment of pediatric HSCT-TMA. did. Due to the FDA's rare pediatric disease designation, Akari will be eligible to receive a priority review voucher (PRV) upon approval of nomacopan, which may be redeemed for priority review of a subsequent marketing application for another product or sold to a third party. I can.
During 2023, Akari also advanced a long-acting form of Nomacopan (PAS-modified Nomacopan) into final stages of preclinical development as a treatment for geographic atrophy (GA). PAS-Nomacopan meets the needs of the patient, including longer dosing intervals between intravitreal injections and reduced choroidal neovascularization (CNV) risk associated with approved complement-only inhibitors currently used to treat GA. are being developed with the potential to address important patient needs that have not yet been developed. Positive preclinical results, including an advanced high-yield manufacturing process that provides the drug with specifications considered suitable for intravitreal administration, led to Phase 1 single and multiple titration to assess safety. Supports the possibility of initiation of clinical development with dose (SAD/MAD) trials. and pharmacokinetics/pharmacodynamics (PK/PD). GA, a progressive, sight-threatening disease, is estimated to affect 5 million people worldwide, including 1 million patients in the United States.
2023 full year financial results
As of December 31, 2023, the company had approximately $3.8 million in cash. The Company expects to receive gross proceeds of approximately $2 million from the sale of ADSs in a private placement from certain existing investors in March 2024 and to secure additional capital in the second quarter of 2024.
Research and development expenses were approximately $5.5 million for the year ended December 31, 2023, compared to approximately $9.6 million for the same period in 2022.
General and administrative expenses were approximately $11.4 million for the year ended December 31, 2023, compared to approximately $13.5 million for the same period in 2022.
Other gross income, net, for the year ended December 31, 2023 was approximately $6.8 million. This compares to approximately $5.3 million for the same period in 2022. Of this amount, $6.6 million and his $5 million (net) came from non-cash net gains. This relates to the company's liability classification warrants issued in connection with the company's September 2022 private placement transaction.
Our net loss for the year ended December 31, 2023 was approximately $10.0 million and our net loss for the same period in 2022 was approximately $17.7 million. The Company's net loss related to its debt classification warrants for the years ended December 31, 2023 and 2022 was $16.6 million and $22.7 million, respectively.
About Akali Therapeutics
kari Therapeutics, plc (Nasdaq: AKTX) is a biotechnology company developing advanced treatments for autoimmune and inflammatory diseases. Akari's lead asset, investigational nomacopan, is a dual-specific recombinant inhibitor of complement C5 activation and leukotriene B4 (LTB4) activity. Akari's pipeline includes a Phase 3 clinical trial program investigating nomacopan for pediatric hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).
Akari receives Orphan Drug, Fast Track and Rare Pediatric Disease designations from the FDA for Nomacopan for the treatment of pediatric HSCT-TMA, and Orphan Drug designation from the European Commission for the treatment of hematopoietic stem cell transplantation. doing. Akali's pipeline also includes preclinical studies 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 press release contains forward-looking statements made within the meaning of the Private Securities Litigation Reform Act of 1995 and in accordance with its safe harbor provisions. All statements contained in this press release, other than statements of historical fact or related statements, present facts or current circumstances. This includes, but is not limited to, statements regarding Akari's clinical development plans, the anticipated completion of the merger of Akari and Peak Bio, Akari's cash and financial resources and anticipated financing routes. These statements involve known and unknown risks, uncertainties and causes that may cause Akari's actual results, performance or achievements to differ materially from any future results, performance or achievements expressed or implied by the forward-looking statements. Includes other important factors that may result in: In some cases, these statements include words such as “may,” “might,” “will,” “should,” “expect,” “plan,” “aim,” and “seek.” ”, “anticipate”, “ “may”, “intend”, “target”, “plan”, “contemplate”, “believe”, “estimate”, “anticipate”; “anticipate,” “may,” “continue,” or the negative meaning of these terms, or other similar expressions.
The forward-looking statements contained in this press release are predictions only. Akali has based, in large part, these forward-looking statements on its current expectations and projections regarding future events and financial trends that Akari believes may affect its business, financial condition and results of operations. Masu. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified; Department is beyond Akali's control. the results of AKARI's clinical development activities on drug candidates in development on anticipated timelines; Akari's ability to successfully integrate operations with Peak Bio; Accuracy of Akari's estimates regarding capital requirements. and Akali's ability to maintain and properly enforce appropriate intellectual property protections. These and other risks and uncertainties are further described in the “Risk Factors” section of Akari's most recent filings with the Securities and Exchange Commission, available at www.sec.gov. These forward-looking statements should not be relied upon as predictions of future events. The events and circumstances reflected in these forward-looking statements may not be achieved or occur, and actual results may differ materially from those anticipated in the forward-looking statements. Additionally, Akari operates in a dynamic industry and economy. New risk factors and uncertainties may emerge from time to time, and it is impossible for management to predict all risks and uncertainties that Akari may face. Unless required by applicable law, Akari will not publicly update or revise any forward-looking statements contained herein, whether as a result of new information, future events, changed circumstances or otherwise. There are no plans to do so.
For more information
Investor contact information:
mike moyer
Life science advisor
(617) 308-4306
mmoyer@lifesciadvisors.com
Media contact:
Eliza Schleifstein
Schleifstein PR
(917) 763-8106
eliza@schleifsteinpr.com
Akari Therapeutics Plc
Condensed Consolidated Statement of Income and Comprehensive Loss
(Unaudited, expressed in USD)
|
year ended |
||||||||
|
December 31 |
||||||||
|
(In thousands, excluding amounts per share) |
2023 |
2022 |
||||||
|
Operating expenses: |
||||||||
|
Research and Development |
$ |
5,450 |
$ |
9,561 |
||||
|
General and administration |
11,356 |
13,527 |
||||||
|
operating loss |
(16,806 |
) |
(23,088 |
) |
||||
|
Other income (expenses): |
||||||||
|
Excess of fair value of stock acquisition rights liability over cash proceeds |
— |
(1,963 |
) |
|||||
|
Changes in fair value of subscription rights |
6,599 |
6,946 |
||||||
|
Other income, net |
199 |
357 |
||||||
|
net loss |
$ |
(10,008 |
) |
$ |
(17,748 |
) |
||
|
Net loss per common share – basic and diluted |
$ |
(0.00 |
) |
$ |
(0.00 |
) |
||
|
Weighted average number of common shares (basic and diluted) used in calculating net loss per share |
9,788,980 |
6,243,462 |
||||||
Akari Therapeutics Plc
Summary consolidated balance sheet data
(Unaudited, expressed in USD)
|
December 31 |
December 31 |
|||||||
|
(in thousands of dollars) |
2023 |
2022 |
||||||
|
cash |
$ |
3,845 |
$ |
13,250 |
||||
|
Other assets |
510 |
582 |
||||||
|
Total assets |
$ |
4,355 |
$ |
13,832 |
||||
|
Total debt |
$ |
4,584 |
$ |
12,041 |
||||
|
Total stockholders' equity (deficit) |
(229 |
) |
1,791 |
|||||
|
Total debt and stockholders' equity (deficit) |
$ |
4,355 |
$ |
13,832 |
||||
