re: CLDX
McBio,
Did you notice this? Buried a bit in the 8-K.
Form 8-K for CELLDEX THERAPEUTICS, INC.
4-Feb-2013
Other Events
Item 8.01. Other Events.
Recent Developments
Certain Recent Balance Sheet Data
While full financial information for the year ended December 31, 2012 is not yet available, Celldex Therapeutics, Inc. (the "Company") is providing the following unaudited preliminary information for the year ended December 31, 2012 as an update. The Company had cash, cash equivalents and short-term investments of approximately $84.0 million at December 31, 2012. The preliminary financial data included in this report has been prepared by, and is the responsibility of, the Company's management. PricewaterhouseCoopers LLP has not audited, reviewed, compiled or performed any procedures with respect to the foregoing preliminary financial data. Accordingly, PricewaterhouseCoopers LLP does not express an opinion or any other form of assurance with respect thereto.
The foregoing selected, unaudited preliminary financial information is based upon the Company's progress to date and does not present all necessary information for an understanding of the Company's financial condition as of December 31, 2012 or its results of operations for the three months and year ended December 31, 2012. The preparation and audit of the Company's consolidated financial statements for the year ended December 31, 2012 is ongoing and could result in material changes to the financial results set forth above.
Recent Sale of Common Stock
Pursuant to a controlled equity offering sales agreement dated as of January 6, 2011, as amended (the "Cantor Agreement") by and between the Company and Cantor Fitzgerald & Co. ("Cantor"), the Company may issue and sell an amount of shares of its common stock having an aggregate offering price of up to $44.0 million from time to time into the open market at prevailing prices through Cantor, acting as agent. The Company agreed to pay Cantor a commission of 3% of the gross proceeds from each sale and to reimburse Cantor for certain expenses incurred in connection with entering into the Cantor Agreement. The Cantor Agreement terminates upon the sale, under the Cantor Agreement, of an amount of shares of the Company's common stock having an aggregate offering price of $44.0 million or upon ten day notice by either Cantor or the Company.
Since September 30, 2012, the Company issued 5,954,798 shares of its common stock under the Cantor Agreement, raising aggregate net proceeds of approximately $38.0 million. As of February 1, 2013, an additional amount of shares of common stock having an aggregate offering price of up to $4.4 million were available for sale under the Cantor Agreement.
CDX-011 Developments
In December 2012, we had our end of Phase 2b meeting with the United States Federal Drug Administration, or FDA, for our CDX-011 program, which we have characterized as positive. Based on this meeting, we intend to initiate a CDX-011 study suitable for accelerated approval in the second half of 2013. We are currently finalizing the clinical trial design and will update investors on our plans for the accelerated approval trial on our year-end 2012 call in early March 2013. Also in December 2012, we announced final results, as shown below, from the EMERGE study which suggested that CDX-011 induces significant response rates compared to currently available therapies in patient subsets with advanced, refractory breast cancers with high glycoprotein NMB, referred to as GPNMB, expression (expression in greater than 25% of tumor cells) and in patients with triple negative breast cancer. The overall survival and progression free survival of patients treated with CDX-011 was also observed to be greatest in patients with triple
negative breast cancer who also highly express GPNMB and all patients with high GPNMB expression.
EMERGE: Overall Response Rate and Disease Control Data
On target effect clearly demonstrated in
targeted patient populations
Triple Negative
High GPNMB and High GPNMB
All Patients Triple Negative Expression Expression
CDX-011 IC CDX-011 IC CDX-011 IC CDX-011 IC
(n=81) (n=36) (n=27) (n=9) (n=25) (n=8) (n=12) (n=4)
Response 16 % 14 % 19 % 0 % 32 % 13 % 33 % 0 %
Disease Control Rate 57 % 53 % 67 % 33 % 64 % 38 % 75 % 25 %
Responses per RECIST 1.1; IC = Investigator's Choice; CDX-011 arm includes 15 patients who crossed over to receive CDX-011 treatment after progression on IC. Analysis of best response excludes patients who discontinued from study without evaluable post-baseline radiographic imaging (n=15 for CDX-011 arm; n=5 for IC arm).
EMERGE: Overall Survival (OS) and Progression Free Survival (PFS) Data
On target effect clearly demonstrated in
targeted patient populations
Triple Negative
High GPNMB and High GPNMB
All Patients Triple Negative Expression Expression
CDX-011 IC CDX-011 IC CDX-011 IC CDX-011 IC
Median OS (months) 7.5 7.4 6.9 6.5 10.0 5.7 10.0 5.5
p=0.24 p=0.30 p=0.18 p=0.003
Median PFS (months) 2.1 2.0 2.3 1.6 2.7 1.5 3.0 1.5
p=0.38 p=0.43 p=0.14 p=0.008
Analyses include all treated patients. Patients who initially received Investigator's Choice (IC) and subsequently crossed over to receive CDX-011 (n=15) are included in the PFS analysis for each treatment. These patients, with a median OS of 12.5 months, are assigned to the IC arm only for OS analysis. Median OS for the remaining IC patients who did not cross over is 5.4 months.
When cross over patients are removed, median OS in patients with high GPNMB expression is 10.0 months for CDX-011 vs 5.2 months for IC (p=0.05) and median OS in triple negative patients with high GPNMB expression is 10.0 months for CDX-011 vs 5.2 months for IC (p=0.009).
Bladerunner
