Akari Therapeutics, Plc (NASDAQ: AKTX) is a biopharmaceutical company focused on developing inhibitors of acute and chronic inflammation, specifically the complement system, the eicosanoid system and the bioamine system for the treatment of rare and orphan diseases, in particular, those where the complement system or leukotrienes or both complement and leukotrienes together play a primary role in disease progression.
Akari has an ongoing discovery and early development program involving several additional tick-derived anti-inflammatory proteins. This pipeline includes a range of new and engineered proteins, including compounds only binding LTB4, histamine, serotonin, and tissue targeting compounds, including an engineered version of Coversin designed to target the neuromuscular junction (NMJ).
The company has been a pretty exciting story in the recent past and has given robust return to the investors, after the feedback from an End-of-Phase 2 meeting with the FDA. AKTX confirmed that it would advance lead candidate Coversin into phase 3 development for the treatment of Paroxysmal Nocturnal Hemoglobinuria in Q1 of 2018.
Paroxysmal Nocturnal Hemoglobinuria indication has Fast Track status in the U.S, and the FDA also mentioned that the company provides safety and efficacy data in the trials. As per management, the company will continue to work closely with the FDA, benefitting from its Fast Track status in the U.S., and with the EMA towards submission of a BLA and MAA, respectively, for Coversin in PNH.
Coversin™. If approved, would compete in the market for PNH and aHUS treatment with Soliris®, (eculizumab) which was developed by Alexion Pharmaceuticals. Eculizumab is the novel therapy presently being approved for PNH, is marketed by Alexion and had sales of approximately $2.8 billion last year. The ability to self-administer Coversin as a fixed-dose daily subcutaneous injection will be an attractive alternative therapy.
Most recently, the company also announced that three additional patients had been enrolled in the ongoing Phase II COBALT clinical trial of Coversin™ in patients with paroxysmal nocturnal hemoglobinuria (PNH). Akari plans to provide an update on all PNH patients currently enrolled at the American Society of Hematology Annual Meeting to be held December 9-12, 2017
The company continues to build momentum in its complement focused therapy by advancing Coversin towards Phase III in PNH and Phase II in aHUS. With Coversin delivered subcutaneously, patients may have higher independence due to self-administration. Phase II studies are also planned for a number of other indications where Coversin’s actions on both the complement and leukotriene (LTB4) pathways play a role. Its two leading targets in this area are atopic keratoconjunctivitis (AKC), a rare eye disorder and severe bullous pemphigoid (BP).
With these developments, AKTX has become an exciting story among small caps biotech plays. The upcoming presentations results/developments are likely to be the near-term catalysts for the stock. The stock currently has an average rating of “BUY” and a consensus price target of $9.00. Considering present valuation, AKTX is at a favorable risk-reward position.
About the company: Akari Therapeutics, Plc (NASDAQ: AKTX ), a biopharmaceutical company focused on the development and commercialization of innovative therapeutics to treat orphan autoimmune and inflammatory diseases. Akari was founded in 2004 and is headquartered in London, U.K.
Pipeline: Akari’s lead drug candidate Coversin is a C5 complement inhibitor currently being evaluated in paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). In addition to its C5 inhibitory activity, Coversin independently and specifically inhibits leukotriene B4 (LTB4) activity. Akari intends to evaluate Coversin in two conditions, the skin and eye diseases bullous pemphigoid and atopic keratoconjunctivitis, where the dual action of Coversin on both C5 and LTB4 may be beneficial. Akari is also developing other tick derived proteins, including long-acting versions.
Latest Quarter Financial position:
As of June 30, 2017, Akari had cash and cash equivalents of $30 million, compared to $44 million as of December 31, 2016. R&D costs were $3.7 million, and general and administrative expenses were $7.3 million.
The company recently raised approximately $17.4 million by way of ADSs. Akari intends to use the net proceeds from the offering to fund its ongoing research and clinical development efforts and for working capital and general corporate purposes.
Key risk factors and potential stock drivers:
- The favorable outcome of the upcoming catalysts (as mentioned above) is expected to provide a boost to the stock to retain its momentum. Any adversities related with the same could upset the stock performance significantly.
- AKTX presently has net level losses. Therefore, any crunch in its liquidity and financial flexibility will further impact its business & financial profile.
- The company’s near-term stock movement is also dependent on its upcoming quarterly result, any significant adversities/lower than expected guidance could adversely affect the investor sentiments.
- Biotech space is a high-risk sector due to uncertainties associated with the novel drug development. Therefore, favorable outcome of the upcoming catalyst is necessary for the stock to retain its momentum. Any adversities related to the same could impinge the stock performance significantly.
- On Monday, November 27th, 2017, AKTX closed at $4.70 (down by -2.49%) on an average volume of 244,352.00 exchanging hands. Market capitalization is $71.71 million. The current RSI is 50.68
- In the past 52 weeks, shares of AKTX have traded as low as $3.18 and as high as $22.20
- At $4.70, shares of AKTX are trading below its 50-day moving average (MA) at $5.32 and below its 200-day moving average (MA) at $6.73
- The present support and resistance levels for the stock are at $4.50 & $4.90 respectively.
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