Minerva Neurosciences Raises Capital - $8.45

Minerva Neurosciences (NERV) filed Form S-3 on August 10. The form S-3 is a three-year prospectus that allows the company to from time to time, at their discretion, sell shares to raise capital up to $200 million. The supplemental part of the prospectus calls for a takedown of up to $50 million worth of stock sales through investment banker Jeffries. The company held approximately $108 million in cash as of 6-30-18. If the company initiates the complete takedown of $50 million, then the cash will increase to around $156 million, and the dilution would be around 6.2 million shares at current prices to increase the total share count to 45 million shares outstanding.  The companies burn rate is around $13 million per quarter at present.
The phase 3 clinical trial readout of MIN-101 for negative symptoms of schizophrenia, is scheduled for the first half of 2019. So beginning the capital raising process now makes sense. The S-3 filing gives the company the discretion of when and how much capital to raise over the next three years. Below is a chart of Minerva. Thank you for reading.

MIN-101 Phase 3 Primary Endpoint - $6.80

Minerva Neurosciences (NERV) has officially begun dosing patients for their pivotal phase 3 clinical trial for the negative symptoms or Schizophrenia. Let's examine the primary endpoint in the phase 3 (Marder NSFS) and compare it with their successfully completed phase 2 primary endpoint PANSS Negative Scale (Pentagonal Structure 5-Factor) to see how the items vary. Below is the phase 2.

Phase 2   PANSS Negative Scale (Pentagonal Structure)            p = 32mg  64mg
N1            Blunted Affect                                                                               .25         .17
N2            Emotional Withdrawal                                                               .01         .02           
N3            Poor Rapport                                                                               .00         .00
N4            Passive/apathetic social withdraw                                          .29         .01
N6            Lack of spontaneity and flow of conversation                      .07          .01
G7            Motor retardation                                                                       .68         .04
G8            Uncooperativeness                                                                     .41          .86
G13          Disturbance of volition                                                              .25          .88
G14          Poor impulse control                                                                  .89         .56

Phase 2   5-Factor Negative Score
32mg p=0.021   effect size 0.45     64mg p=0.003  effect size 0.58

Below is the phase 3 Marder NSFS (negative symptom factor score) items that will be tested versus placebo.

Phase 2   Marder Negative Symptoms Factor Score (NSFS)       p = 32mg  64mg
N1             Blunted Affect                                                                             .25         .17
N2            Emotional Withdrawal                                                              .01         .02
N3            Poor Rapport                                                                               .00         00
N4            Passive/apathetic social withdraw                                          .29         .01
N6            Lack of spontaneity                                                                    .07         .01
G7            Motor retardation                                                                       .68         .04
G16          Active social avoidance                                                              .01         .00

Notice that the phase 2 design included G8, G13, and G14, which scored the lowest on effect for the phase 2 primary endpoint, but will not be included in the phase 3 Marder (NSFS) primary endpoint. The currently running phase 3 primary endpoint includes the same items as the phase 2, (minus G8, G13, G14) with the inclusion of G16 (active social avoidance) which scored a .01 and .00 respectively in the phase 2 clinical trial. The Marder items that were included in the phase 2, would have scored better in itself, than the phase 2 primary endpoint PANSS Negative Scale (Pentagonal Structure) 5-Factor Negative Score of p=0.021 and p=0.003, which was achieved with the 32mg and 64mg dose. Thank you for reading.
   

Minerva Neurosciences - $6.05

We wrote about Minerva Neursciences  (NERV) when they were just completing some important corporate goals in anticipation of upcoming clinical trials. The lead drug is MIN-101 for negative symptoms of Schizophrenia, which is scheduled to start a 500 patient study soon. Patients will be recruited throughout Europe, with 30% of participants coming from the US. Currently there is not an FDA approved drug for negative symptoms of Schizophrenia, so this fits into our category of an unmet medical need. The phase 2 clinical trial with MIN-101 proved to be effective. The results of that clinical trial are below.
 
PANSS Negative Symptom Score at 12 Weeks

• 32mg  p = 0.021    effect size   .45
• 64mg  p = 0.003   effect size .  58

The 500 patient phase 3 study is to determine if MIN-101 is effective again, for the negative symptoms of Schizophrenia. The patent for MIN-101 extends out to 2035. Thank you for reading.
 

Minerva Neurosciences (NERV)

Minerva Neurosciences, is a drug development company addressing the unmet need of Schizophrenia, with a focus on the negative symptoms of the disease. The company will be entering a pivotal phase 3 clinical trial in the second half of 2017 with 500 patients from the US and Europe. A bit of history into their phase 2b clinical trial produced significant results from this press release Phase IIb study of MIN-101. The company solved three underlying issues that prevented them from being investment suitable. 

1. Raising capital with a 5M share offering at $7.75, announced yesterday, bringing total cash to around 118M.
2. Ran a Bridging Study with a BFB-520 metabolite improved MIN-101, and have filed for patent that could exceed 2035 expiration for the GR version.
3. FDA approved their design of the phase 3 pivotal clinical trial that should initiate the second half of 2017.

Quick Facts
Shares: around 41 million
Cash: around 118 million
MIN-101 MR patent:  2035
MIN-101 GR patent:  2035+

There is not an FDA approved drug specifically for negative symptoms of Schizophrenia. Minerva is now in the lead as far as clinical trials initiated with the start of this phase 3 scheduled for the second half of 2017. Thank you for reading.