On September 27, 2022 Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company focused on advanced therapies for autoimmune and inflammatory diseases, reported financial results for the quarter ended June 30, 2022, as well as pre-clinical and clinical progress on nomacopan and long-acting PAS-nomacopan (Press release, Akari Therapeutics, SEP 27, 2022, View Source [SID1234621438]). Investigational nomacopan is a bispecific recombinant inhibitor of complement C5 and leukotriene B4 (LTB4) currently being investigated in a Phase 3 clinical trial for use in severe pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA) and a pre-clinical program is developing long-acting PASylated nomacopan in geographic atrophy (GA) in dry age-related macular degeneration (dAMD).
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"We sharpened our pipeline focus on two programs that have the potential to address areas of significant unmet need for patients, including our Phase 3 clinical trial in severe pediatric HSCT-TMA that we believe is the shortest path to value creation for our investors," said Rachelle Jacques, President and CEO of Akari Therapeutics. "The recently announced financing provides us with the cash needed to bring our HSCT-TMA program to our next important milestone, which is the Part A data readout we expect in the first half of 2023, and to advance our promising pre-clinical program investigating PAS-nomacopan in geographic atrophy."
Akari Recent Progress and Highlights
Amidst a very challenging capital markets environment, Akari successfully closed a registered direct offering with healthcare-focused institutional and accredited investors, including participation of certain existing investors for the issuance of an aggregate 15,100,000 American Depositary Shares (ADSs) at $0.85 per ADS and a concurrent private placement of series A warrants to purchase 15,100,000 ADSs and series B warrants to purchase 15,100,000 ADSs for aggregate gross proceeds of approximately $12.8 million
Proceeds from the offering will support Akari’s narrowed pipeline focus, including the Phase 3 Part A clinical trial of nomacopan in severe pediatric HSCT-TMA and the promising pre-clinical program developing long-acting PAS-nomacopan in GA
The Phase 3 Part A clinical trial of nomacopan in severe pediatric HSCT-TMA remains on track for a data readout in the first half of 2023
Akari continues to participate in the U.S. Food and Drug Administration (FDA) Model Informed Drug Development (MIDD) program that, along with a robust PK/PD model, supported dose selection and rapid advancement into the Phase 3 Part A clinical trial of nomacopan in severe pediatric HSCT-TMA
Akari clinical data from 38 subjects in previous nomacopan clinical studies and healthy volunteers supported a PK/PD model and model simulations of 10,000 virtual patients that were used to inform FDA MIDD interactions that confirmed PK/PD model suitability and dosing selected for the Phase 3 Part A clinical trial of nomacopan in severe pediatric HSCT-TMA
Positive results from recent pre-clinical studies support the advancement of long-acting PAS-nomacopan toward IND/IMPD for clinical trials in GA as well as the potential for the investigational treatment to address areas of unmet patient needs
PK measurements have indicated the half-life of early generation PAS-nomacopan in a standard ophthalmic pre-clinical model can be accurately predicted, which supports work to develop new generation PAS-nomacopan that may enable dosing intervals of more than three months between intravitreal injections with the potential of an acceptable low dose volume
Pivotal data recently released on a late-stage complement-only inhibitor (not nomacopan) further reinforce the efficacy of C5 inhibition in GA. Pre-clinical PAS-nomacopan is a bispecific inhibitor of both complement C5 and LTB4, which is important because previously presented data show LTB4 inhibition by PAS-nomacopan may also reduce the risk of sight-threatening choroidal neovascularization (CNV), a safety risk associated with current late-stage complement-only inhibitors.
Second Quarter 2022 Financial Results
As of June 30, 2022, the Company had cash of approximately $8.2 million, compared to cash of approximately $9.4 million as of December 31, 2021. Following the end of the second quarter, Akari closed a registered direct offering of 15,100,000 ADSs along with a concurrent private placement of series A warrants to purchase 15,100,000 ADSs and series B warrants to purchase 15,100,000 ADSs, resulting in approximately $12.8 million in gross proceeds.
Research and development expenses for the second quarter 2022 were approximately $2.9 million, as compared to approximately $2.2 million in the same quarter the prior year. This increase of 31% or $0.7 million was primarily due to increased expenses due to the timing of manufacturing of nomacopan to support ongoing clinical trials.
General and administrative expenses for the second quarter 2022 were approximately $3.0 million, as compared to approximately $2.1 million in the same quarter the prior year. This increase of 43% or $0.9 million was primarily due to increased consulting fees for services such as strategic advisory, investor relations, and other activities.
For the second quarter 2022, total other income was approximately $136,000 as compared to total other expense of approximately $16,000 in the second quarter of 2021. This $152,000 increase was primarily attributed to foreign currency exchange gains in the current period as compared to foreign currency exchange losses in the prior period.
Net loss for the second quarter 2022 was approximately $5.7 million, as compared to approximately $4.3 million for the period of 2021. This increase was primarily due to the aforementioned higher research and development expenses as well as higher general and administrative expenses.
Net cash used in operating activities for the six months ended June 30, 2022 was approximately $13.6 million, as compared to approximately $12.3 million for the six months ended June 30, 2021. This increase was primarily due to the aforementioned higher net loss as well as an increase in prepaid expenses and other current assets.