I happened to ask IR today if the others outside the executive agreements were safe and as far as everyone knows right now, there will be no major changes.
I also confirmed that the products and intellectual properties are safe and not assignable to either U.S. or Russian governments. .In his executive agreement, Andrei protected some of his IP that is unrelated to CBLI.
Davidovich likes the science and Andrei and would like both to succeed.
Cats, going back to your cash flow analysis, with the $25m and presumably the DoD $15M, this should give them $22M or 18 - 24 months of time, within which much will happen. The balance of the investment ~$7M will also allow them to pay for the expenses incurred on the remaining BLA work since the DoD money is on a reimbursement basis.
What I do not get is that pre-split this is still around $.25. Netting out the dilution, where would it be if BARDA came through with $25M?
It should be $4-5 or $80 - $100 once the DoD and EUA are confirmed. In 20 months or so with purchases lined up it should be $10-15 pre split or $200-$300.
Well they'll have much needed cash and that is always better than chapter 7. Sold 60% of the company at 36% higher than market price. I hope he doesn't screw the rest of us. I'm not an expert but I think you have to hold unregistered shares for a year or more.
I just hope his intention is to make a lot of money based on everything being in place except cash. With this and hopefully the cost of the BLA reimbursed by the DoD, it should provide some breathing, room, diluted breathing room.
6.459,948 unregistered shares sold to VC David Davidovich, Russian billionaire at $3.87 in a private placement exemption, will own 60% of the company. Expanded board to 13 members.
It remains to be shown whether Neupogen provides survival benefit after lethal radiation if given without multiple types of supportive care and intensive medical monitoring, while Entolimod was shown to rescue animals as a single stand-alone treatment.
As for the Neupogen efficacy data presented, we thought it might be helpful to provide some comparisons to our own recently completed LD70 pivotal GLP study and previously conducted non-GLP studies. The Neupogen study cited in the briefing document involved daily dosing for up to two weeks, or 14 doses starting at 24 hours post irradiation and resulted in an approximately 1.9 fold increase in survival.
Another study discussed at the meeting failed to show benefit when dosing occurred 48 hours after total body irradiation. This would compare to the Entolimod regimen of a single dose given at 25 hours post LD70 irradiation, which resulted in an approximately 2.5 fold increase in survival from 27.5% in the control animals to 75% in the Entolimod groups at the higher doses. Or the regimen of a single dose given at the 48 hour time point post LD75 irradiation resulting in approximately a 2.7 fold increase in survival from 25% in the control to 67% with Entolimod. Furthermore, in non-GLP studies, Entolimod was shown to work if administered before irradiation while Neupogen was not recommended and not shown to have benefit for pre-radiation use.
So, all of these data points go to the question of suitability of these interventions in a large scale versus small scale casualty scenario, with representatives from BARDA specifically noting in the meeting that countermeasures for a modeled 10KT event in NYC were the target of their interest. Under such scenario, access to platelet transfusions and complex supportive care would clearly be limited. Here again, we believe we have strong advantages over Neupogen and other leukocyte growth factor products.
That is correct, it would likely be stockpiled, since it does meet more of the EUA criteria, can be self administered, non-refrigerated, shelf life, large quick production runs, etc...
So BARDA wanted 2.8M does and the contract is for $157M ??? That cannot be $157M for 2.8M doses???
I listened to the FDA advisory committee meeting on this and you would have never thought the vote would be 17-1 in favor of Neupogen be cleared for ARS. There was so much doubt and concern over the lack of data for this indication, they just needed a short term fix, but $157M for a stop gap measure does not pass the smell test so that is a lot of palm grease.
From 2013 CC:
In Entolimod's pivotal primate study, there was only minimal supportive care offered to these animals, limited to analgesic patches to reduce the stress and suffering of these animals in addition to a single dose administration of Entolimod.
Notice Type: Special Notice
Posted Date: 04-JUN-15
Office Address: Department of the Army; U.S. Army Medical Research Acquisition Activity; US Army Medical Research Acquisition Activity, ATTN: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014
Subject: A-- Notice of Intent to Sole Source
Classification Code: A - Research & Development
Contact: Jesse Hoffman, 301-619-2765 mailto:email@example.com [US Army Medical Research Acquisition Activity]
Description: Department of the Army
U.S. Army Medical Research Acquisition Activity
U.S. Army Medical Research Acquisition Activity
The United States Army Medical Research Acquisition Activity (USAMRAA), 820 Chandler Street, Fort Detrick, Maryland, 21702, intends to award a sole source contract to Cleveland Biolabs to advance research for Advanced Development of Entolimod (CBLB502) To Mitigate and Treat the Acute Effects of Ionizing Radiation. The proposed contract action is for services for which the Government intends to solicit and negotiate with only one source under the statutory authority permitting other than full and open competition is 10 U.S.C. 2304(c)(1), FAR citation is 6.302-1(a)(2)(iii) and the FAR citation title is only one responsible source and no other supplies or services will satisfy agency requirements for these highly specialized research services. This requirement is in support of The Congressionally Directed Medical Research Program (CDMRP) Fort Detrick, Maryland, 21702. In accordance with FAR Part 6.302-1 (a)(2)(iii), USAMRAA intends to award a sole source contract to Cleveland Biolabs under NAICS code 541712.
I posted the whole PR and it was up and then the other half disappeared. I tried to post the ASCO abstract last week but could not. But plenty of spam - go figure. The last post is only the last two paragraphs of the Roswell PR.
immunotherapeutic anticancer agent.
“Our findings are encouraging, as they suggest that entolimod can be safely combined with other chemotherapeutic, targeted or immunotherapeutic agents as treatment for advanced and very hard-to-treat cancers,” notes Dr. Adjei, who is Senior Vice President of Clinical Research and the Katherine Anne Gioia Chair in Cancer Medicine at Roswell Park. “We’ve identified a recommended dosing schedule for future studies.”
The study, “A phase I study of the toll-like receptor 5 (TLR5) agonist, entolimod, in patients with advanced cancers,” is abstract 3063 and will be presented on board no. 389 during the Developmental Therapeutics—Immunotherapy poster session on Saturday, May 30 from 8 a.m. to 11:30 a.m. CDT in McCormick Place, S Hall A.