Biotech stocks for your portfolio: Celldex Thera

Biotech stocks for your portfolio: Celldex Therapeutics, Inc. (CLDX), Dynavax Technologies Corporation (DVAX)
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Celldex Therapeutics, Inc. (CLDX) ended last trading session with a change of 0.23 percent. It trades at an average volume of 4.10M shares versus 3.8M shares recorded at the end of last trading session. The share price of $4.38 is at a distance of 47.97 percent from its 52-week low and down -85.54 percent versus its peak. The company has a market cap of $432.09M and currently has 98.65M shares outstanding. The share price is currently 21.62 percent versus its SMA20, -28.31 percent versus its SMA50, and -69.08 percent versus its SMA200. The stock has a weekly performance of 18.06 percent and is -72.07 percent year-to-date as of the recent close.

Celldex Therapeutics, Inc. (CLDX) on February 25, 2016 reported financial highlights for the fourth quarter and year ended December 31, 2015.

Cash position: Cash, cash equivalents and marketable securities as of December 31, 2015 were $289.9 million compared to $304.6 million as of September 30, 2015. The decrease was primarily driven by our fourth quarter cash used in operating activities of approximately $22.9 million, partly offset by the receipt of $9.2 million from the sale of New Jersey tax benefits. As of December 31, 2015 Celldex had 98.7 million shares outstanding.

Revenues: Total revenue was $1.8 million in the fourth quarter of 2015 and $5.5 million for the twelve months ended December 31, 2015, compared to $1.5 million and $3.6 million for the comparable periods in 2014. The increase in revenue was primarily due to our clinical trial collaboration with Bristol-Myers Squibb and our research and development agreement with Rockefeller University.

R&D Expenses: Research and development (R&D) expenses were $23.9 million in the fourth quarter of 2015 and $100.2 million for the twelve months ended December 31, 2015, compared to $27.0 million and $104.4 million for the comparable periods in 2014. R&D expenses include stock-based compensation expense of $2.0 million and $6.2 million in the three- and twelve-month periods ended December 31, 2015 compared to $1.1 million and $3.5 million for the comparable periods in 2014.

G&A Expenses: General and administrative (G&A) expenses were $11.1 million in the fourth quarter of 2015 and $33.8 million for the twelve months ended December 31, 2015, compared to $6.2 million and $20.6 million for the comparable periods in 2014. The increase in G&A expenses was primarily attributable to higher personnel-related expenses as we prepare for potential commercialization and a $6.5 million increase in RINTEGA and glembatumumab vedotin commercial planning costs in 2015 as compared to 2014. G&A expenses include stock-based compensation expense of $2.1 million and $6.6 million in the three- and twelve-month periods ended December 31, 2015 compared to $1.0 million and $3.4 million for the comparable periods in 2014.

Net loss: Net loss was $32.7 million, or ($0.33) per share, for the fourth quarter of 2015 and $127.2 million, or ($1.31) per share, for the twelve months ended December 31, 2015, compared to a net loss of $31.8 million, or ($0.36) per share, and $118.1 million, or ($1.32) per share, for the comparable periods in 2014.

Dynavax Technologies Corporation (DVAX) recently recorded 0.37 percent change and currently at $21.50 is 38.53 percent away from its 52-week low and down -33.83 percent versus its peak. It has a past 5-day performance of 16.72 percent and trades at an average volume of 1.22M shares. The stock has a 1-month performance of 26.1 percent and is -11.01 percent year-to-date as of the recent close. There were about 36.73M shares outstanding which made its market cap $789.70M. The share price is currently 20.49 percent versus its SMA20, 11.12 percent versus its SMA50, and -12.06 percent versus its SMA200.

Dynavax Technologies Corporation (DVAX) on March 30, 2016 announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for HEPLISAV-B™, the company’s vaccine candidate for immunization against hepatitis B infection in adults 18 years of age and older. The FDA has established September 15, 2016 as the Prescription Drug User Fee Act (PDUFA) action date.

The HEPLISAV-B BLA is based on positive immunogenicity results from clinical trials that have generated safety data in more than 10,000 participants. Results of these trials showed that two doses of HEPLISAV-B given one month apart provides significantly higher rates of protection with an equivalent safety profile compared to three doses of Engerix-B, a currently marketed hepatitis B vaccine that is administered over six months. In Phase 3 studies across all participants, HEPLISAV-B achieved peak seroprotection rates of 95.7 percent compared with 79.5 percent for Engerix-B. Additionally, in more than 1,100 participants with diabetes, HEPLISAV-B provided seroprotection rates of 90 percent compared to 65.1 percent for Engerix-B.

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