Last up to bat we have Akari Therapeutics, which develops innovative treatments for autoinflammatory diseases involving the complement (C5) and leukotriene (LTB4) pathways. Given its strong execution and share price of only $2.14, is now the right time to get in on the action?
According to B.Riley FBR’s Mayank Mamtani, the answer is a resounding yes. At the end of May, the company provided an update on the progress of the clinical trials for bullous pemphigoid (BP), atopic keratoconjunctivitis (AKC) and pediatric transplant-induced thrombotic microangiopathy (HSCT-TMA) indications for its lead program, nomacopan. The candidate is also getting attention for its potential as a therapeutic option for COVID-19 patients.
The 5-star analyst thinks the full Phase 2 BP study results, as well as an orphan designation granted by the FDA and EMA, free AKTX up to kick off end-of-Phase 2 meetings with the FDA and EMA in Q3 2020 to discuss the pivotal Phase 3 trial design. These meetings would address important considerations including enrolling severe patients in addition to mild and moderate, increasing treatment duration from 1.5 to 6 months, an option to dose at 30 mg-plus levels and a choice of active versus comparator arms, including possibly combining or sequencing with steroids.
“There were no treatment-related serious AEs, in line with the favorable tolerability profile noted in other indications (e.g., PNH), highlighting further differentiation relative to steroid standard of care,” Mamtani stated.
However, Mamtani doesn’t dispute the fact that the COVID-19 pandemic has delayed site initiation activities for the Phase 3 HSCT-TMA trial to later in 2020 and the enrollment for the Part B placebo-controlled efficacy cohort of the Phase 1/2 study in severe AKC patients has been halted. That said, Mamtani notes “the interim update remains on track for mid-2020 in ~2/3rd of the targeted 16 patients already enrolled in the study.” He added, “The prior open-label data of nomacopan eye drops demonstrated in three severe atopic keratoconjunctivitis (AKC) patients rapid overall improvement in composite clinical scores of symptoms and signs.”
On top of this, preclinical data has found complement (C5) and leukotriene (LTB-4) pathways may play a role in severe lung inflammation and microthrombi and organ damage associated with COVID-19. This creates an opportunity for nomacopan as it has been shown to produce a “profound and broad-acting anti-inflammatory effect.”
To wrap it all up, Mamtani commented, “We believe AKTX has held up well in the volatile macro environment as investors look to take advantage of the depressed stock levels for this late-stage biotech supported by robust clinical data generated in earlier-stage trials, with incremental Phase 1/2 severe AKC placebo-controlled data anticipated in mid-2020.”
Everything the company has going for it prompted Mamtani to stay with the bulls. Along with a Buy rating, he kept his $5 price target as is, bringing the upside potential to 134%. (To watch Mamtani’s track record, click here)
Turning now to the rest of the Street, it has been quiet when it comes to other analyst activity. Mamtani’s call was the only one issued recently.
Recent AKTX News
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 09/18/2024 08:40:20 PM
- Form 3 - Initial statement of beneficial ownership of securities • Edgar (US Regulatory) • 09/18/2024 08:36:53 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 09/18/2024 08:34:49 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 09/16/2024 08:05:40 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 09/16/2024 04:15:15 AM
- Form S-4 - Registration of securities, business combinations • Edgar (US Regulatory) • 09/13/2024 09:30:10 PM
- Form S-3 - Registration statement under Securities Act of 1933 • Edgar (US Regulatory) • 09/06/2024 09:23:08 PM
- Form 8-K/A - Current report: [Amend] • Edgar (US Regulatory) • 08/23/2024 08:30:09 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/19/2024 08:30:27 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/19/2024 08:15:08 PM
- Form NT 10-Q - Notification of inability to timely file Form 10-Q or 10-QSB • Edgar (US Regulatory) • 08/15/2024 08:15:02 PM
- Form SC 13D/A - General statement of acquisition of beneficial ownership: [Amend] • Edgar (US Regulatory) • 06/20/2024 11:30:07 AM
- Form SC 13D - General statement of acquisition of beneficial ownership • Edgar (US Regulatory) • 06/18/2024 08:15:30 PM
- Form SC 13D - General statement of acquisition of beneficial ownership • Edgar (US Regulatory) • 06/07/2024 10:00:16 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/05/2024 09:00:15 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/04/2024 08:45:04 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 06/04/2024 08:45:03 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/04/2024 12:02:04 PM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 06/03/2024 08:21:04 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/16/2024 12:05:16 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 05/15/2024 08:47:39 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/07/2024 09:05:29 PM
- Kuehn Law Encourages VIVK, MINM, SDPI, and AKTX Investors to Contact Law Firm • PR Newswire (US) • 03/15/2024 04:53:00 PM
- Form 425 - Prospectuses and communications, business combinations • Edgar (US Regulatory) • 03/11/2024 09:25:08 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 03/11/2024 09:24:24 PM
VHAI - Vocodia Partners with Leading Political Super PACs to Revolutionize Fundraising Efforts • VHAI • Sep 19, 2024 11:48 AM
Dear Cashmere Group Holding Co. AKA Swifty Global Signs Binding Letter of Intent to be Acquired by Signing Day Sports • DRCR • Sep 19, 2024 10:26 AM
HealthLynked Launches Virtual Urgent Care Through Partnership with Lyric Health. • HLYK • Sep 19, 2024 8:00 AM
Element79 Gold Corp. Appoints Kevin Arias as Advisor to the Board of Directors, Strengthening Strategic Leadership • ELMGF • Sep 18, 2024 10:29 AM
Mawson Finland Limited Further Expands the Known Mineralized Zones at Rajapalot: Palokas step-out drills 7 metres @ 9.1 g/t gold & 706 ppm cobalt • MFL • Sep 17, 2024 9:02 AM
PickleJar Announces Integration With OptCulture to Deliver Holistic Fan Experiences at Venue Point of Sale • PKLE • Sep 17, 2024 8:00 AM