- Akari’s priority pipeline programs remain on track to begin enrollment in the registrational nomacopan Phase 3 clinical trials in pediatric and adult HSCT-TMA and start PAS-nomacopan clinical trials in geographic atrophy (GA)
- Granted orphan drug designation from the
European Commission for treatment in hematopoietic stem cell transplantation, adding to existing FDA Orphan Drug, Fast Track and Rare Pediatric Disease designations - The company established a Boston
U.S. headquarters office to support expanding operations and the start of registrational Phase 3 clinical trials - Strengthened capabilities with appointment of
Beth-Anne Lang , an experienced executive with a long track record of successful regulatory approvals, as Senior Vice President, Regulatory Affairs, and industry veterans Wa’el Hashad as independent director andWendy DiCicco as interim CFO
“I’m delighted our Akari team continues to make steady progress on our ambitions for investors and the patients who are waiting with urgent unmet needs,” said
HSCT-TMA
Akari remains on track to start enrollment by the end of 2023 in the registrational Phase 3 study of nomacopan in pediatric HSCT-TMA, which is expected to generate safety and efficacy data that may support
Consensus guidelines were published in early 2023 by an international panel of experts that harmonize diagnostic criteria and support earlier screening and diagnosis in the care of patients. The design of Akari’s HSCT-TMA Phase 3 clinical trials has been significantly informed by these consensus criteria for earlier diagnosis of high-risk (severe) patients. Adult study design will be an important topic of discussion during a Type C meeting with the
A case study, Clinical Response to Nomacopan in the Paediatric HSCT-TMA Setting, was presented as a late-breaker at The Transplantation & Cellular Therapy Tandem Meetings in
Akari was granted orphan drug designation from the
Akari is also moving forward into a registrational Phase 3 double-blind placebo-controlled clinical trial of nomacopan in adult HSCT-TMA with enrollment expected to begin in 2024 (subject to funding).
Regulatory authorities in
Geographic Atrophy (GA)
Akari completed evaluation of long-acting PAS-nomacopan candidates and based on extensive pre-clinical work selected a single drug candidate to move forward into clinical trials for treatment of GA. The selected version has a product profile with characteristics important for a GA therapy, including fully active drug potency, planned small (<100µL) injection volume, viscosity enabling intravitreal injection with a fine needle, and pre-clinical half-life that supports a potential clinical dose interval of 3 months or longer.
Akari also selected
In May, Akari hosted a key opinion leader event featuring
Other Highlights
As Akari approaches the start of registrational Phase 3 clinical trials in pediatric and adult HSCT-TMA and a regulatory filing to begin clinical trials in GA, the company will be assisted by
The
Akari appointed experienced life sciences executive
The company established a Boston Seaport area office that is the Akari
Akari continues to secure IP for lead asset nomacopan in pipeline programs beyond current priority programs in preparation for future development by the company, licensing or partnering. In
After requesting and being granted a 180-day extension by Nasdaq to meet Nasdaq’s minimum bid price requirement, the company regained compliance in
As Akari continues to build out the capabilities, presence, and investor base in the
First Half of 2023 Financial Results
As of
Research and development expenses were approximately
Net loss was approximately
About
Cautionary Note Regarding Forward-Looking Statements
Certain statements in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, our product development efforts, business, financial condition, results of operations, strategies or prospects and statements related to the offering of securities described herein, the expected gross proceeds and the expected closing of the offering. These forward-looking statements reflect our current views about our plans, intentions, expectations, strategies, and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies, and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations, or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control. Such risks and uncertainties for our company include, but are not limited to: needs for additional capital to fund our operations, our ability to continue as a going concern; uncertainties of cash flows and inability to meet working capital needs; an inability or delay in obtaining required regulatory approvals for nomacopan and any other product candidates, which may result in unexpected cost expenditures; our ability to obtain orphan drug designation in additional indications; risks inherent in drug development in general; uncertainties in obtaining successful clinical results for nomacopan and any other product candidates and unexpected costs that may result there; difficulties enrolling patients in our clinical trials; failure to realize any value of nomacopan and any other product candidates developed and being developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; inability to develop new product candidates and support existing product candidates; the approval by the FDA and EMA and any other similar foreign regulatory authorities of other competing or superior products brought to market; risks resulting from unforeseen side effects; risk that the market for nomacopan may not be as large as expected risks associated with the impact of the COVID-19 pandemic; inability to obtain, maintain and enforce patents and other intellectual property rights or the unexpected costs associated with such enforcement or litigation; inability to obtain and maintain commercial manufacturing arrangements with third party manufacturers or establish commercial scale manufacturing capabilities; the inability to timely source adequate supply of our active pharmaceutical ingredients from third party manufacturers on whom the company depends; unexpected cost increases and pricing pressures and risks and other risk factors detailed in our public filings with the
Condensed Consolidated Statements of Operations and Comprehensive Loss
(Unaudited, in
Six Months Ended | |||||||
2023 | 2022 | ||||||
Operating expenses: | |||||||
Research and development expenses | $ | 3,255,221 | $ | 4,990,715 | |||
General and administrative expenses | 5,954,379 | 6,069,422 | |||||
Total operating expenses | 9,209,600 | 11,060,137 | |||||
Loss from operations | (9,209,600 | ) | (11,060,137 | ) | |||
Other income: | |||||||
Interest income | 59,091 | 8,317 | |||||
Change in fair value of warrant liability | 6,147,210 | — | |||||
Foreign currency exchange gain | 27,516 | 211,761 | |||||
Other expenses | (22,825 | ) | (16,314 | ) | |||
Total other income, net | 6,210,992 | 203,764 | |||||
Net loss | $ | (2,998,608 | ) | $ | (10,856,373 | ) | |
Net loss per ordinary share, basic and diluted | $ | (0.00 | ) | $ | (0.00 | ) | |
Weighted average ordinary shares outstanding — basic and diluted | 8,787,337,361 | 5,648,226,680 | |||||
Comprehensive loss: | |||||||
Net loss | $ | (2,998,608 | ) | $ | (10,856,373 | ) | |
Other comprehensive loss: | |||||||
Foreign currency translation adjustment | (55,038 | ) | (80,590 | ) | |||
Total comprehensive loss | $ | (3,053,646 | ) | $ | (10,936,963 | ) |
Consolidated Balance Sheet Data
(Unaudited, in
2023 | 2022 | ||||||
Cash | $ | 7,180,688 | $ | 13,249,945 | |||
Other assets | 832,283 | 581,667 | |||||
Total assets | $ | 8,012,971 | $ | 13,831,612 | |||
Total liabilities | $ | 5,231,514 | $ | 12,040,866 | |||
Total shareholders’ equity | 2,781,457 | 1,790,746 | |||||
Total liabilities and shareholders’ equity | $ | 8,012,971 | $ | 13,831,612 |
For more information
Investor Contact:
(617) 308-4306
mmoyer@lifesciadvisors.com
Media Contact:
Schleifstein PR
(917) 763-8106
eliza@schleifsteinpr.com
Source:
2023 GlobeNewswire, Inc., source