Apr 18, 2016

Posted by in Biotech Stocks | 0 Comments

Stocks Highlights: Eleven Biotherapeutics Inc (NASDAQ:EBIO), Repros Therapeutics Inc (NASDAQ:RPRX), Celldex Therapeutics Inc (NASDAQ:CLDX)

Stocks Highlights: Eleven Biotherapeutics Inc (NASDAQ:EBIO), Repros Therapeutics Inc (NASDAQ:RPRX), Celldex Therapeutics Inc (NASDAQ:CLDX)

Eleven Biotherapeutics Inc (NASDAQ:EBIO) stock is at $0.578, up +1.58 percent from its previous close of $0.57. The stock opened the session at $0.67 and touched its highest price point at $0.78. The company’s stock’s lowest price point for the session stood at $0.52. Its yesterday’s volume was 11.97 million shares in comparison to its usual trading volume of 1.19 million shares.

Eleven Biotherapeutics Inc (NASDAQ:EBIO) on March 24, 2016 reported financial results for the fourth quarter and full year ended December 31, 2015.

Revenue was $0.6 million for the three months ended December 31, 2015, compared to $0.4 million for the same period in 2014. Revenue was $1.0 million for the twelve months ended December 31, 2015, compared to $2.2 million for the same period in 2014.

R&D Expenses: Research and development expenses were $8.1 million for the three months ended December 31, 2015, compared to $5.3 million for the same period in 2014. This increase was primarily due to higher EBI-031 related development expenses partially offset by decreases in isunakinra related development expenses. Research and development expenses were $26.3 million for the twelve months ended December 31, 2015, compared to $26.7 million for the same period in 2014.

Net loss applicable to common stockholders was $10.3 million, or $0.53 per share, for the three months ended December 31, 2015, compared to net loss applicable to common stockholders of $8.1 million, or $0.49 per share, for the same period in 2014. Net loss applicable to common stockholders was $33.5 million, or $1.76 per share, for the twelve months ended December 31, 2015, compared to net loss applicable to common stockholders of $34.7 million, or $2.37 per share, for the same period in 2014.

Cash and Cash Equivalents: Cash and cash equivalents were $36.1 million as of December 31, 2015. We believe that our current cash and cash equivalents, after giving effect to the $14.9 million prepayment to Silicon Valley Bank, will be sufficient to fund our operating expenses into the fourth quarter of 2016.

Repros Therapeutics Inc (NASDAQ:RPRX) stock is at $2.27, down -14.98 percent from its previous close of $2.67. Its yesterday’s volume was 8.05 million shares in comparison to its usual trading volume of 3.61 million shares. Previous 5 days graph demonstrated a positive move of 152.22%. Its quarterly performance remained green with the percentage of 129.29, while its year to date performance showed that the stock advanced overall 92.37%.

Repros Therapeutics Inc (NASDAQ:RPRX) on April 12, 2016 reported that vaginal administration of Proellex® at doses of both 6 and 12 mg achieved significant reduction in excessive menstrual bleeding, the key symptom of uterine fibroids.

Normal menstrual blood loss in a menstrual cycle is approximately 35 mL. Woman experiencing blood loss of >80 mL are considered to suffer from menorrhagia or excessive menstrual bleeding. In this small Phase 2b study, 13, 15 and 14 women with confirmed uterine fibroids were enrolled in the 6mg, 12mg and placebo arms, respectively. At baseline, the mean amount of blood lost for one menstrual cycle was 255 mL, 274 mL and 238 mL for each arm, respectively. The blood loss ranged from a low of 94 mL to a high of 654 mL. The most severe menstrual bleeding at baseline was observed in the 12 mg group. Blood loss was determined by collecting all sanitary products used from an individual and then an alkaline hematin assay was performed to estimate the actual amount of blood collected in the pads.

When a sufficient concentration of Proellex® is achieved in circulation, amenorrhea (cessation of menses) is achieved. Just over half, 52%, of Proellex®-treated subjects became amenorrheic with no evidence of a dose effect. All subjects treated with Placebo continued to menstruate throughout the 18 week dosing period. The p-value for this comparison is 0.0011.  Bleeding diaries consistently report a statistically significant difference in the number of days of bleeding and bleeding intensity between those treated with Proellex® and Placebo.

Bleeding was also evaluated by PBAC (Pictorial Blood Assessment Chart).  Subjects tallied sanitary product usage and stain size as guided by the chart.  Proellex®-treated subjects reported a median 100% reduction in PBAC scores while Placebo-treated subjects reported a 25.4% reduction, further supporting the treatment affect associated with bleeding (p=0.0033).

Along with changes in menstrual patterns, fibroids measured by MRI were reduced in volume in the Proellex®-treated arms by 18% while the Placebo group showed continued increase in size, p= 0.0437.

The drug was generally well tolerated. Women in the drug arms continued to exhibit levels of estradiol consistent with bone preservation.

After the first 18 week treatment period, the women were withdrawn from drug to allow for menses. The women in the study are currently being treated with the second course of treatment for another 18 weeks. The study treatment assignment remains blinded to the subjects, physicians and those managing the study and data. The results of the second course of treatment should be reported within the next 5 months.

Celldex Therapeutics Inc (NASDAQ:CLDX) traded in the range of $4.45 and $4.69 in its previous trading session. The stock recorded the volume of 6.35 million shares so far, in comparison its average daily trading volume of 4.81 million shares. Company’s year to date performance remained declining as it lost almost -71.23%. The stock opened at $4.60 and its closing price for the day was $4.64, up +0.87 percent from its previous close.

Celldex Therapeutics Inc (NASDAQ:CLDX) on March 7, 2016 announced that the independent Data Safety and Monitoring Board (DSMB) has determined, based on a preplanned interim analysis, that continuation of the Phase 3 ACT IV study of RINTEGA® (rindopepimut) in patients with newly diagnosed EGFRvIII-positive glioblastoma will not reach statistical significance for overall survival in patients with minimal residual disease, the primary endpoint of the study, as both the RINTEGA arm and the control arm are performing on par with each other. In the ACT IV study, RINTEGA has performed consistently with prior  Phase 2 studies but the control arm has significantly outperformed expectations (Hazard ratio = 0.99; median OS: RINTEGA 20.4 months vs. control 21.1 months). Based on this recommendation, Celldex is discontinuing the study and does not anticipate incurring substantial additional costs related to RINTEGA at this time. All patients on the RINTEGA arm of the ACT IV study, prior Phase 2 studies and existing compassionate use recipients will be offered ongoing access to RINTEGA on a compassionate use basis. Celldex first received the data after market close on Friday, March 4th and is in the process of reviewing the results.

 

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