Akari Therapeutics(AKTX) - 2023 Q4 - Annual Results

Executive Summary Akari Therapeutics reported full-year 2023 financial results and recent highlights, including a definitive merger agreement with Peak Bio Inc - Akari Therapeutics reported full-year 2023 financial results and recent highlights, including a definitive merger agreement with Peak Bio Inc[1][2][4] - CEO Rachelle Jacques noted the company advanced Phase 3 and pre-clinical programs and paved the way for a merger to expand the pipeline and create new growth opportunities, despite challenging economic conditions[3] Company Highlights & Strategic Developments Akari Therapeutics announced a definitive merger with Peak Bio Inc., expanding its pipeline and initiating a strategic assessment Merger Agreement with Peak Bio Akari reached a definitive agreement to merge with Peak Bio Inc. in an all-stock transaction, forming a combined entity that will retain the Akari Therapeutics, Plc name and Nasdaq listing - Akari announced a definitive agreement to merge with Peak Bio Inc. in an all-stock transaction, operating as Akari Therapeutics, Plc and continuing to trade on Nasdaq[4] Expanded Pipeline Post-Merger The merger will expand Akari's pipeline to include a robust antibody drug conjugate (ADC) toolkit, a Phase 2-ready neutrophil elastase inhibitor (NEI) program, nomacopan in Phase 3, and long-acting PAS-nomacopan - The combined entity will have an expanded pipeline including: * Robust antibody drug conjugate (ADC) toolkit with novel payload and linker technologies * Phase 2-ready neutrophil elastase inhibitor (NEI) program targeting alpha-1 antitrypsin deficiency (AATD) * Nomacopan (bispecific inhibitor of complement C5 and LTB4) in Phase 3 for pediatric HSCT-TMA * Long-acting PAS-nomacopan for geographic atrophy (GA)[5] Strategic Pipeline Assessment A strategic assessment is planned to evaluate and prioritize the four programs in the expanded pipeline, aiming to identify updated timelines and near-term value creation opportunities, with completion expected before the merger closes - A strategic assessment of the pipeline is planned to evaluate development, program prioritization, updated timelines, and near-term value creation opportunities[6][7] - The assessment is expected to be complete prior to the closing of the merger[7] Clinical Development Programs Akari is advancing nomacopan in Phase 3 for pediatric HSCT-TMA and PAS-nomacopan in pre-clinical development for geographic atrophy Nomacopan for Pediatric HSCT-TMA The Phase 3 Part A clinical trial for nomacopan in pediatric HSCT-TMA is actively recruiting patients, with 10 treated to date, focusing on PK/PD and dose confirmation. Nomacopan has received multiple regulatory designations, including FDA Orphan Drug, Fast Track, and Rare Pediatric Disease designations, making it eligible for a Priority Review Voucher Phase 3 Clinical Trial Update The Phase 3 Part A trial for nomacopan in pediatric HSCT-TMA is actively recruiting, focusing on PK/PD and dose confirmation - The Phase 3 Part A clinical trial for nomacopan in pediatric HSCT-TMA is recruiting patients, with 10 treated to date, focusing on PK/PD and dose confirmation. Enrollment is guided by new consensus criteria for earlier diagnosis of high-risk patients[8] - HSCT-TMA is a rare complication with no approved treatments and an 80% mortality rate in severe patients, positioning nomacopan as a potential first approved treatment[9] Regulatory Designations Nomacopan has received multiple regulatory designations, including FDA Orphan Drug, Fast Track, and Rare Pediatric Disease - Nomacopan received Orphan Drug designation from the European Commission for hematopoietic stem cell transplantation[10] - FDA granted Orphan Drug, Fast Track, and Rare Pediatric Disease designations for nomacopan for pediatric HSCT-TMA, making Akari eligible for a Priority Review Voucher (PRV) upon approval[10] PAS-Nomacopan for Geographic Atrophy (GA) Akari advanced the long-acting PAS-nomacopan into the final stages of pre-clinical development for geographic atrophy, demonstrating positive pre-clinical results and a suitable manufacturing process for intravitreal administration, supporting potential initiation of Phase 1 clinical development. GA affects an estimated 5 million people worldwide - Long-acting PAS-nomacopan advanced into final stages of pre-clinical development as a treatment for geographic atrophy (GA)[11] - Positive pre-clinical results, including an advanced high-yielding manufacturing process suitable for intravitreal administration, support the potential initiation of Phase 1 clinical development[11] - PAS-nomacopan is being developed to address significant unmet patient needs, including a longer dose interval and reduction of choroidal neovascularization (CNV) risk associated with approved complement-only inhibitors[11] - GA is a progressive and sight-threatening condition estimated to affect 5 million people worldwide, including 1 million patients in the U.S.[12] Full-Year 2023 Financial Results Akari Therapeutics reported its full-year 2023 financial results, highlighting reduced operating expenses and a lower net loss Key Financial Metrics As of December 31, 2023, Akari had approximately $3.8 million in cash. The company received an additional $2.0 million in gross proceeds from a private placement in March 2024 and plans to secure more capital in Q2 2024 Cash Position | Metric | December 31, 2023 | December 31, 2022 | Change | | :----- | :------------------ | :------------------ | :----- | | Cash | $3.8 million | $13.25 million | ▼ $9.45 million | - In March 2024, the company received approximately $2.0 million in gross proceeds from certain existing investors from the sale of ADSs in a private placement and is planning to secure additional capital in the second quarter of 2024[13] Operating Expenses Research and development expenses decreased by 43% to $5.5 million in 2023, while general and administrative expenses also saw a 16% reduction to $11.4 million, contributing to a lower loss from operations Operating Expenses Summary | Expense Category | 2023 (in thousands) | 2022 (in thousands) | YoY Change | | :--------------- | :------------------ | :------------------ | :--------- | | R&D | $5,450 | $9,561 | ▼ 43.0% |\ | G&A | $11,356 | $13,527 | ▼ 16.0% |\ | Loss from operations | $(16,806) | $(23,088) | ▼ 27.2% | Other Income and Net Loss Total other income, net, increased to $6.8 million in 2023, primarily due to non-cash gains from liability-classified warrants. This, combined with reduced operating expenses, led to a significant decrease in net loss to $10.0 million for the year Other Income and Net Loss Summary | Metric | 2023 (in thousands) | 2022 (in thousands) | YoY Change | | :----- | :------------------ | :------------------ | :--------- | | Total other income, net | $6,800 | $5,300 | ▲ 28.3% |\ | Net non-cash gains (warrants) | $6,600 | $5,000 | ▲ 32.0% |\ | Net loss | $(10,008) | $(17,748) | ▼ 43.6% |\ | Net loss (excluding non-cash gains) | $(16,600) | $(22,700) | ▼ 26.9% | About Akari Therapeutics Akari Therapeutics is a biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, with lead asset nomacopan - Akari Therapeutics, plc is a biotechnology company developing advanced therapies for autoimmune and inflammatory diseases[17] - Akari's lead asset, investigational nomacopan, is a bispecific recombinant inhibitor of complement C5 activation and leukotriene B4 (LTB4) activity, currently in a Phase 3 clinical trial program for pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA)[17][18] - Akari's pipeline also includes pre-clinical research of long-acting PAS-nomacopan in geographic atrophy (GA)[19] Cautionary Note Regarding Forward-Looking Statements This section outlines the inherent risks and uncertainties associated with forward-looking statements in the press release - This press release contains forward-looking statements subject to known and unknown risks, uncertainties, and other important factors that may cause Akari's actual results, performance, or achievements to be materially different[20][22] - These statements are based largely on current expectations and projections about future events and financial trends and speak only as of the date of the press release[21] - Readers should not rely on these forward-looking statements as predictions of future events, and Akari does not plan to publicly update or revise them except as required by applicable law[22] Contact Information Provides contact details for investor relations and media inquiries - Investor Contact: Mike Moyer, LifeSci Advisors, (617) 308-4306, mmoyer@lifesciadvisors.com[23] - Media Contact: Eliza Schleifstein, Schleifstein PR, (917) 763-8106, eliza@schleifsteinpr.com[23] Financial Statements Presents the unaudited condensed consolidated statements of operations and balance sheet data for 2023 and 2022 Condensed Consolidated Statements of Operations and Comprehensive Loss The unaudited condensed consolidated statements of operations show a net loss of $10.0 million for 2023, a significant improvement from $17.7 million in 2022, driven by reduced R&D and G&A expenses and increased other income Statements of Operations and Comprehensive Loss | Metric | Year Ended Dec 31, 2023 (in thousands) | Year Ended Dec 31, 2022 (in thousands) | | :------------------------------------------ | :------------------------------------- | :------------------------------------- | | Research and development | $5,450 | $9,561 |\ | General and administrative | $11,356 | $13,527 |\ | Loss from operations | $(16,806) | $(23,088) |\ | Change in fair value of warrant liability | $6,599 | $6,946 |\ | Other income, net | $199 | $357 |\ | Net loss | $(10,008) | $(17,748) |\ | Net loss per ordinary share — basic and diluted | $(0.00) | $(0.00) |\ | Weighted-average number of ordinary shares | 9,788,980 | 6,243,462 | Condensed Consolidated Balance Sheet Data The unaudited condensed consolidated balance sheet data shows a decrease in cash from $13.25 million in 2022 to $3.85 million in 2023, and a shift from shareholders' equity of $1.79 million to a deficit of $(0.23) million Balance Sheet Data | Metric | December 31, 2023 (in thousands) | December 31, 2022 (in thousands) | | :-------------------------- | :------------------------------- | :------------------------------- | | Cash | $3,845 | $13,250 |\ | Other assets | $510 | $582 |\ | Total assets | $4,355 | $13,832 |\ | Total liabilities | $4,584 | $12,041 |\ | Total shareholders' (deficit) equity | $(229) | $1,791 |