Replies to post #155336 on Biotech Values

[DewDiligence]

CLDX raising $75M of stock on unspecified terms:

http://finance.yahoo.com/news/celldex-announces-75-000-000-210100024.html

[bladerunner1717]

re: CLDX


Positive Data From Celldex's Phase 1 Study of CDX-301 Support Initiation of Pilot Study in Hematopoietic Stem Cell Transplantation
Final Study Results Presented in an Oral Session at the 2013 BMT Tandem Meetings
NEEDHAM, Mass., Feb. 14, 2013 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (Nasdaq:CLDX) presented final results yesterday from a Phase 1 study of CDX-301 (recombinant human Flt3L; rhuFlt3L) in healthy volunteers that strongly support the initiation of a pilot study in hematopoietic stem cell transplantation later this year. The data were presented by Michael Yellin, MD, Vice President of Clinical Science at Celldex, in an oral presentation at the American Society for Blood and Marrow Transplantation 2013 BMT Tandem Meetings. The study was conducted at Rockefeller University by Niroshana Anandasabapathy, MD, PhD, who worked as an instructor in clinical investigation in the laboratory of the late Nobel Laureate Ralph Steinman, MD.
"The final results from this study are consistent with previous clinical experience and demonstrate that CDX-301 is well-tolerated and can effectively mobilize hematopoietic stem cell populations as a single agent in healthy volunteers," said Dr. Yellin. "Based on the safety profile and the impressive increases observed for CD34+ stem cells and dendritic cells, we believe CDX-301 holds significant promise in both the allogeneic and autologous transplant setting, including the potential for combination with other molecules that could work in synergy with CDX-301 to further enhance the mobilization of hematopoietic stem cell populations. Published pre-clinical Flt3L studies also suggest that CDX-301 could potentially improve engraftment and reduce the risk of graph versus host disease. This may be especially important for older patients and patients who are in poor health."
Study results:
30 healthy volunteers were enrolled across seven cohorts. The first five cohorts assessed escalating doses of CDX-301 (from 1 mcg/kg to 75 mcg/kg) as a five-day regimen, while the final two cohorts assessed CDX-301 (at 25 mcg/kg) as seven- and 10-day regimens. All volunteers completed dosing and safety follow-up. Short-term dosing of five days resulted in a median of 10-fold increases in CD34+ cells—stem cells that have the ability to give rise to all cell types in the blood. Of note, on day 10 of dosing, a greater than 100-fold increase in dendritic cells—cells believed to play a critical role in the long-term improvement of transplant outcome—was observed in the peripheral blood. CDX-301 was generally well-tolerated with transient grade 1 lymphadenopathy observed in six volunteers (all treated at the highest dose levels of 25 mcg/kg and 75 mcg/kg). No anti-CDX-301 antibodies were detected in any volunteers through the end of study follow-up.
CDX-301 or rhuFlt3L is a potent cytokine that stimulates the expansion and differentiation of hematopoietic progenitor and stem cells. rhuFlt3L has demonstrated a unique capacity to increase the number of circulating dendritic cells in both laboratory and clinical studies. In addition, rhuFlt3L has shown impressive results in models of cancer, infectious diseases and inflammatory/autoimmune diseases. The clinical safety and activity of rhuFlt3L were originally demonstrated by Immunex (now Amgen) in clinical trials involving more than 150 healthy volunteers and 380 patients with cancer. Recognizing the promise of CDX-301, Celldex in-licensed the program from Amgen in 2009. Celldex's completion of this recent Phase 1 study confirms and builds upon the extensive prior clinical experience and reaffirms the significant potential for CDX-301.



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[bladerunner1717]

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).


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