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Cleveland BioLabs

Termination of coverage

Update | Pharmaceuticals & healthcare | 03 Feb 2014

Edison Investment Research is terminating coverage on Cleveland BioLabs (CBLI). Please note you should no longer rely on any previous research or estimates for this company. All forecasts should now be considered redundant.

Cleveland BioLabs

Patiently waiting for BARDA

Update | Pharmaceuticals & healthcare | 19 Nov 2013

BARDA's review of Cleveland's application for a development contract to support Entolimod as a radiation countermeasure is taking longer than anticipated. This is disappointing and brings uncertainty, but the fundamentals have not changed o BARDA has a stated need for a range of radiation countermeasures and Entolimod is the most advanced candidate in terms of supporting efficacy and safety data. Meanwhile, research contracts have been secured to help develop Cleveland's emerging oncology pipeline. We value Cleveland at $100m, or $2.20 per share.

Futura Medical

Edison healthcare quarterly: Immuno-oncology 2: The combos come

Sector Commentary: | Pharmaceuticals & healthcare | 06 Nov 2013


Cleveland BioLabs

Hercules completes a task for Cleveland

Update | Pharmaceuticals & healthcare | 04 Oct 2013

Cleveland has secured a $10m loan from venture debt specialist Hercules Technology Growth Capital. The $6m upfront tranche extends the cash runway into Q214 (from Q114) and provides a buffer against further delays in receiving the much anticipated BARDA development contract award for Entolimod as a radiation countermeasure. We view this as a logical move, particularly in light of the recent US government shutdown, and the largely non-dilutive nature of the financing and Hercules' due diligence and established track record in life sciences are encouraging features.

Cleveland BioLabs

Oncology pipeline advancing

Update | Pharmaceuticals & healthcare | 19 Aug 2013

While Cleveland awaits a potential BARDA development contract worth up to $50m for Entolimod as a radiation countermeasure, the company has made some significant advances with its oncology pipeline. In particular, CBL0137 is emerging as a promising candidate, given the evidence building behind FACT, the molecular target for CBL0137, as an accelerator of tumour transformation and a potential marker for aggressive cancers. Two Phase I studies are underway with CBL0137, and, with the biomarker research, a compelling data package for partnering and/or fresh finance could be forthcoming by 2015. We maintain our $2.30 per share valuation.

Trillium Therapeutics

Edison healthcare quarterly: Immunotherapy takes centre stage

Sector Commentary: | Pharmaceuticals & healthcare | 31 Jul 2013


Cleveland BioLabs

Keeping the faith in BARDA

Update | Pharmaceuticals & healthcare | 17 May 2013

Uncertainty over the timing and outcome of a BARDA development contract award to support Cleveland's radiation countermeasure candidate Entolimod has dragged on the stock, which is down 15% over the last 30 days. While the lack of a definitive answer is cause for some anxiety, we remain hopeful that the ~$50m development contract will be secured. A recent FDA advisory committee review confirmed the need for multiple medical countermeasure options in the event of a major radiological

Merrimack Pharmaceuticals

Edison healthcare quarterly: German (drug) reformation

Sector Commentary: | Pharmaceuticals & healthcare | 10 Apr 2013


Cleveland BioLabs

First line of biodefence

Outlook | Pharmaceuticals & healthcare | 26 Mar 2013

Cleveland's near-term investment case rests on its ability to successfully develop Entolimod (CBLB502) as the first FDA-approved medical countermeasure to reduce death from total body irradiation. A major near-term catalyst, and critical to Entolimod's chances of securing substantial US government procurement contracts in 2015, is a BARDA development contract award in Q213. The BARDA contract, worth up to $50m, would fund the final pivotal studies (animal efficacy and human safety) required to submit a BLA in Q414. We value Cleveland at $102m ($2.30/share), mainly based on winning a BARDA supply contract in 2015 worth >$200m.

Cleveland BioLabs

First line of (bio)defence

QuickView | Pharmaceuticals & healthcare | 15 Jan 2013

Cleveland BioLabs' biodefence franchise is fundamental to its near-term investment case and 2013 should see significant progress in the development of Entolimod (CBLB502) as the first available treatment for acute radiation syndrome (ARS). A potential development funding contract from BARDA in H113 is a major stock catalyst and financing event. Pivotal studies in animals and humans are planned for 2013 and a BLA submission is targeted for Q414. Entolimod, a TLR5 agonist, also holds potential as an anti-cancer agent, with a Phase I study to complete in Q413.