Akari announced the company has reached 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.
Following closing, the company will have an expanded pipeline that contains multiple compelling assets spanning early and late development stages, including: a robust antibody drug conjugate (ADC) toolkit with novel payload and linker technologies, a Phase 2-ready neutrophil elastase inhibitor (NEI) program targeting alpha-1 antitrypsin deficiency (AATD), nomacopan, a bispecific inhibitor of two immune pathways (complement C5 and leukotriene B4/LTB4) in Phase 3 development for pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA), and long-acting PAS-nomacopan for geographic atrophy (GA).
A strategic assessment of the pipeline is planned to evaluate development of the four programs including program prioritization, updated timelines, near-term value creation opportunities, and other considerations. The assessment is expected to be complete prior to the closing of the merger.
The Phase 3 Part A clinical trial of investigational nomacopan in pediatric HSCT-TMA is studying multiple age groups with a focus on PK/PD and dose confirmation. Akari is continuing to recruit patients into the Part A portion of the Phase 3 clinical trial that has treated 10 patients to date. Enrollment in Part A is guided by new consensus criteria published in 2023 supporting earlier screening and diagnosis of high-risk (severe) patients with HSCT-TMA. The Phase 3 clinical trial also is expected to include a Part B portion focusing on safety and efficacy. Plans for initiation of the Part B study will be guided by the strategic pipeline assessment.
HSCT-TMA is a rare complication of stem cell transplant that has no approved treatment options and an 80% mortality rate among severe patients. Nomacopan is in development as potentially the first treatment approved for the condition.
Akari was granted orphan drug designation from the European Commission for treatment in hematopoietic stem cell transplantation, and FDA Orphan Drug, Fast Track and Rare Pediatric Disease designations for nomacopan for the treatment of pediatric HSCT-TMA. With the FDA Rare Pediatric Disease Designation, Akari is eligible to receive a Priority Review Voucher (PRV) upon approval of nomacopan that it can either redeem for priority review of a subsequent marketing application for a different product or sell to a third party.
During 2023, Akari also advanced the long-acting version of nomacopan (PASylated nomacopan) into the final stages of pre-clinical development as a treatment for geographic atrophy (GA). PAS-nomacopan is being developed with the potential to address significant unmet patient needs, including a longer dose interval between intravitreal injections and reduction of choroidal neovascularization (CNV) risk associated with approved complement-only inhibitors currently used for treatment of GA. Positive pre-clinical results, including an advanced high-yielding manufacturing process that provides a drug with specifications considered suitable for intravitreal administration, support the potential initiation of clinical development with Phase 1 single and multiple ascending dose (SAD/MAD) testing to evaluate safety and pharmacokinetics/ pharmacodynamics (PK/PD). A progressive and sight-threatening condition, GA is estimated to affect 5 million people worldwide, including 1 million patients in the U.S.
Full-Year 2023 Financial Results
As of December 31, 2023, the company had cash of approximately $3.8 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.
Research and development expenses were approximately $5.5 million for the year ended December 31, 2023, as 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, as compared to approximately $13.5 million for the same period in 2022.
Total other income, net was approximately $6.8 million for the year ended December 31, 2023, as compared to approximately $5.3 million for the same period in 2022, of which $6.6 million and $5.0 million (net) 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 $10.0 million for the year ended December 31, 2023, as compared to net loss of approximately $17.7 million for the same period in 2022. Excluding the net non-cash gains of approximately $6.6 million and $5.0 million (net) for the years ended December 31, 2023 and 2022, respectively, related to the company's liability-classified warrants, net loss was $16.6 million and $22.7 million, respectively.
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