Updated Investor Presentation/Slide Deck — Now on File At The SEC…

kalobios-nyc-present-02-2017You may now review it here.

This is what was presented in Manhattan this week.

And separately, the investor that likely bought Mr. Shkreli’s stake in August 2016, still holds the same position at year end, 2016 — as it did then.

Now you know.

Namaste…

Company To Present On Its Forecasts — In NYC This Week…

kalobios-nyc-present-02-2017We will keep an eye on this for you, our dear readers(!):

KaloBios, a biopharmaceutical company focused on advancing medicines for patients with neglected and rare diseases, announced that Cameron Durrant, MD, chairman and CEO, will present a company overview at the 2nd Annual Disruptive Growth & Healthcare Conference on Thursday, February 16, 2017 at 1:15 p.m. EST.

The conference will be held February 15-16, 2017 at Convene 730 Third Avenue in New York City. A live webcast of the presentation will be available….

We will listen in. And report, if anything materially new is learned.

In The “No Obvious Explanation” Department: A Stock Sell-Off, On High Volumes, Today…

kalo-new-old2Try as I might, I can find no single piece of news (nor an aggregate of an assortment of little pieces) that would explain the ferocious sell-off move KBIO witnessed today. [Recall that it rallied double-digit percentages, in a day, in mid-November 2016 — from $2.50 to $3.83 (see graphic below). That was on specific positive news from major stakeholders. Today, however, it gave all of that back.]

Billy was first to alert us to it — and (to my eye) this is a good, and very candid three page interview recently given by Dr. Durrant — which mentions Mr. Shkreli several times. It is candid about the challenges KaloBios faces, but all of it looks to have been long ago disclosed. SO… I cannot explain the move.

Now, in the land of “highly unlikely” influences — can’t imagine that anyone seriously thinks the new, and orange-hued United States President’s worsening relations with our fine, friendly neighbors to the South would be a reason to walk away from a Chagas treatment bet. [But maybe that’s a bit of it: will the “Big Cheeto” have any interest in helping “littler” people — even to blunt the effect of US citizens’ kalobios-gyrations-11-2016exposure to tropical diseases? Will he simply say we all should stay out of South and Central America? In fairness, he has said far crazier things in recent weeks.]

I realize I am clutching at straws here — and I have no long or short position in KaloBios — but why the move? Why… today?! I wonder…

I’ll keep looking.

Namaste….

Cross-Posted From Shkreli Ass Hat Website; Of Birthing Memes & “Billy” Test Post Edition…

shkreli-uc-davis-poop-bombed-2017 [This content also appears on the Shkreli site.] It ultimately doesn’t much matter whether he was pelted with a clump of wet leaves, or with dog feces, when he went out to engage his detractors at UC Davis last Friday night.

The object lesson was that this is how memes are born. Just use Google News to find the “Turd, meet turd” Shkreli meme.

There is no other news value here — so I will use this also as a “test” thread for Billy, now that I’ve reset all the knobs and twiddly bits, behind the curtains here — in an attempt to make his comments easier to post.

Try a test comment, here as well, Kid.

Out — to LA for the rest of the week.

FDA Staff: KaloBios Allowed To Submit/Use Existing Data To Clear FDA — On Chagas Program…

kalobios-fda-green-light-2017This is welcome news for KaloBios — but in truth, both PathoPhilia and I had long predicted it. [For nearly a year, now.] Onward, then — for the New KaloBios:

Here’s a bit — but do go read it all, in an SEC Form 8-K filed this morning:

…Meeting minutes received from the FDA’s Division of Anti-Infective Products confirmed key elements of the company’s overall plan for benznidazole, including:

  • The company’s proposed 505(b)(2) approach to demonstrate safety and efficacy using some data drawn from previously conducted studies is acceptable to FDA….
  • If approved as a treatment for Chagas, benznidazole is currently expected to be eligible for a priority review voucher (PRV), awarded to sponsors of certain treatments for neglected tropical diseases that meet criteria specified by the Federal Food, Drug, and Cosmetic (FD&C) Act.

“This guidance makes it clear that we are on the right track with our development of benznidazole for Chagas disease, and we expect we will progress expeditiously toward a submission,” said Cameron Durrant, MD, KaloBios chairman and CEO. “Our team continues to execute and we look forward to further collaborative engagement with FDA….”

Now you know — stay bundled up, one and all!

We begin our walk in, under cloudless but frigid skies — as wind-chills hover near minus ten. But our hearts — they be warmed. . . as a quick trip out to L.A.’s sunshine, looms for later next week. . . smile.

नमस्ते

KaloBios “Unredacts” Portions Of The Chagas Agreement — In Response To SEC Staff Comments

kalobios-clears-fda-pre-meet-12-16This is a working thread — as I watch New Year’s Eve sporting events… on the couch. More to come, as I see things, here:

Late on the last business day of the year, KaloBios filed an amended Exhibit 10.9 to its Q3 2016 SEC Form 10-Q in which it disclosed more provisions of the Chagas commercialization arrangement — with Savant Neglected Diseases. That was last night.

As the cover sheet to the latest SEC filing indicates, the SEC had asked for additional disclosures. That is not surprising, given that I was asking many of the same questions a few months ago. [Here is the prior, more redacted version, for the record.]

It is hard to imagine how almost all these provisions would not be material to KaloBios’ future fortunes, and ongoing results of operations.

Back with observations shortly. UPDATE: it seems the first and perhaps only change in redaction is that we now know the limits (caps) on indmenification for breaches by the company. That had previously been redacted — here it is in full:

KaloBios-SEC-Forms-2016….Indemnification by the Company for Breach of Representation or Warranty. Notwithstanding the provisions of Section 12.1, the Company shall not be liable for Losses under Section 12.1(a) unless the aggregate amount of Losses with respect to all misrepresentations or breaches of warranty exceed Three Hundred Thousand Dollars ($300,000) (the “Indemnification Basket”), in which event all Losses incurred shall be subject to indemnification. The Company’s aggregate liability for all Losses under Section 12.1(a) shall not exceed the lesser of (i) the consideration actually received by the Company under this Agreement and (ii) Five Million Dollars ($5,000,000) (the “Cap”)….

Namaste and Happy New Year…

Kalobios Gets New Loan Terms From Black Horse, Et Al. — Extends Date For Registered Resale Shares

kalobios-resale-shares-2017-8-kThe company filed a pair of SEC Form 8-Ks here, and here — overnight.

I don’t read too much into either of them. Here’s a bit:

…On December 21, 2016, the Company entered into a Credit and Security Agreement (the “Credit Agreement”) with Black Horse Capital Master Fund Ltd., as administrative agent and lender (“BHCMF” or “Agent”), Black Horse Capital LP, as a lender (“BHC”), Cheval Holdings, Ltd., as a lender (“Cheval”) and Nomis Bay LTD, as a lender (“Nomis” and, together with BHCMF, BHC and Cheval, the “Lenders”). The Credit Agreement provides for a credit facility in the original principal amount of $3,315,217.00 (the “Term Loan”). The Credit Agreement provides that the Term Loan will be made by the Lenders at an original discount equal to $265,217.00 (the “Upfront Fee”) and requires the payment by the Company to the Lenders of a commitment fee equal to $152,500.00 (the “Commitment Fee”). In accordance with the terms of the Credit Agreement, the Company will use the proceeds of the Term Loan for general working capital, the payment of certain fees and expenses owed to the Agent and the Lenders in connection with the Credit Agreement and other costs incurred in the ordinary course of business.

 
kalo-new-old2Pursuant to the terms of the Credit Agreement, the Term Loan will bear interest at a rate per annum equal to 9.00%. The Term Loan is subject to certain customary representations, warranties and covenants.
 
The outstanding principal balance of the Term Loan, plus accrued and unpaid interest, plus the Commitment Fee and all other non-contingent obligations (the “Outstanding Obligations”), will mature on the earlier of acceleration after an event of default under the Credit Agreement, or October 31, 2017 (the “Maturity Date”).  However, to the extent the Company raises capital through any SEC-registered stock offering, 50% of such offering’s proceeds (net of costs) must be used to pay down the Term Loan.
 
Upon the occurrence of any event of default set forth in the Credit Agreement, the Agent has the option of terminating the Credit Agreement and declaring all of the Company’s obligations immediately payable. The occurrence of an event of default will cause the Term Loan to bear interest at a rate per annum equal to 14.00%. 
 
The Company’s obligations under the Credit Agreement will be secured by first priority security interests in all of the Company’s real and personal property, subject only to certain carve outs and permitted liens, as set forth in the Credit Agreement. The Company has and will, at the request of the Agent, enter into additional documents further documenting the Term Loan and securing the Company’s obligations under the Credit Agreement in favor of the Agent and for the benefit of the Lenders.
 
The foregoing description of the Credit Agreement does not purport to be complete and is qualified in its entirety by reference to the Credit Agreement filed as Exhibit 10.1 hereto and incorporated herein by reference….
 
In connection with the Credit Agreement, the Company executed in favor of the Agent an Intellectual Property Security Agreement, dated as of December 21, 2016 (the “IP Security Agreement”). Under the terms of the IP Security Agreement, the Company has pledged to the Agent for the ratable benefit of the Lenders, as collateral for its obligations under the Credit Agreement, all of its intellectual property.
 
The foregoing description of the IP Security Agreement does not purport to be complete and is qualified in its entirety by reference to the IP Security Agreement filed as Exhibit 10.2 hereto and incorporated herein by reference….
Now you know. And… Merry Christmas!