It's hard to know what to believe these days. There's so many unexplainable things out there. Even when something sounds good & proves to be good, doesn't always mean a successful stock or company. Just like with women.
How long can it possibly take to find a partner? Is CNCE just being picky or are companies just confused with all the different types of kidney diseases out there? How many types are there? Perhaps CNCE hasn't found a way to advertise CTP-499 to all the different companies? Maybe it's hard getting the word out. Or maybe since CNCE has done most of the work, maybe companies would get a smaller percentage of the profit coming in at Phase 3 rather than Phase 1 or 2. Maybe they're having a hard time figuring out if it's worth their time & funds for a smaller percentage of the profit.
My major purchase was at $15.75. But I also bought it in my 401k for $11.30. I don't have much in 401k though. I got screwed all the way down. I never dreamed this stock would go as low as it did.
CTP-354 was a drug originally made by Merck & Co. But it showed substantial pharmacokinetic limitations and as a consequence, never made it past the lab. So Concert took over the drug and should be able to remove the limitations to make the drug do what it was meant to do, but perhaps even better.
I certainly hope so :0) I don't understand how it has under-performed all other biotechs.
70-80%, while anti-spasticity effects are expected at receptor occupancy levels of 30% (as seen with other
benzodiazepines). CTP-345 is easily hitting sustained plasma concentrations sufficient for these occupancy levels in the 6mg cohort for up to 48 hours after a single dose and additionally avoiding concentrations that would cause serious sedative effects. Also, Phase II plans for CTP-345 in spinal cord injury will include a three-dose trial design with the highest dose likely to be 12mg. The company stated its goal is to improve Ashcroft scores by 25-30%. FDA trial guidance gives CNCE optionality with CPT-499 Phase III trial design
heading into SPA discussions. During the call, the company reiterated the results from its successful FDA end-of-Phase II meeting where consideration would be given to a single multi-dose, placebo-controlled Phase III trial for approval, in contrast to initial expectations of two separate Phase III trials. Time-to-event analysis – a composite endpoint including a ≥50% increase in serum creatinine levels or progression to ESRD will likely be confirmed as the approval endpoint. This inclusion of a rapidly assessable biomarker to support the responder analysis is highly encouraging from both a time and cost perspective, in our view. The potential incorporation of higher baseline UACR levels (as a predictor of more rapid disease progression) as inclusion criteria may also shorten the time to trial readout. Significant upside potential for this deuterated drug company. We remain bullish on Concert Pharmaceuticals shares seeing several opportunities for growth over the next several years in addition to CTP-499 including: CTP-354, JZP-386, AVP-786 and CTP-730. In our opinion, the company’s DCE Platform® has all the requisite ingredients to allow CNCE to become one of the leading developers of unique, deuterated-therapeutic compounds. We reiterate our Market Outperform rating and $28 price target for CNCE shares based on our DCF and SOTP
Highlights Early Clinical Progress in 2Q14 Earnings Results
MARKET OUTPERFORM | Price: $8.60 | Target Price: $28.00
Concert Pharmaceuticals detailed development plans and current Phase I results
for CTP-354, and discussed progress for CTP-499 and partnered programs;
reiterate Market Outperform rating and $28 price target based on DCF and SOTP
valuation methodologies. CNCE reported 2Q14 net loss of $7.73MM, or EPS of
($0.45) that was higher than the JMP estimate of ($0.53), primarily on lower than
anticipated operating expenses and higher total revenues. License revenue of $1.24MM
was higher than our estimate of $0MM. Total operating expense of $8.96MM was
lower than our $9.5MM estimate, comprising $6.24MM of R&D expense (lower than
our estimate of $7.5MM) and $2.72MM of SG&A expense (higher than our estimate of
$2MM). CNCE finished the quarter with $101MM in cash, cash equivalents and short term
investments providing sufficient cash runway into 2016. A summary of 2Q14 actual
results versus JMP estimates is shown in Figure 2. Incremental changes to our model
reflecting 2Q14 results and calculated share count are summarized in Figure 3.
Results from Phase I Multiple Ascending Dose Phase I trial of CTP-345 support
advancement into spasticity indication. CNCE initially plans to advance CTP-354,
a deuterated subtype selective GABAa receptor antagonist, into Phase II clinical trials
to treat spasticity in patients with spinal cord injury. The company discussed results
from its Phase I trial covering two multiple-dose data points of 6mg at five hours and
6mg at 48 hours demonstrating receptor occupancy of up to 50%. We believe this
information, coupled with the results previously reported in single-ascending Phase I
trials, support the potential to achieve a clinical response at dosages that are below
the threshold for adverse events. Unwanted sedative effects had previously been seen
at doses of 20mg, reflective of receptor occupancy levels of up to
Roth Capital affirms Concert Pharmaceuticals (Nasdaq: CNCE) at Buy with a target price of $28 following the company's Q2 results.
Concert reported Q2 loss of $0.45 per share versus Roth's estimated loss of $0.47 per share.
Analyst Joseph Pantginis commented, We believe Concert is making good progress on their clinical programs, both in their in-house and partnered programs. The company's R&D expenses are expected to grow as they initiate multiple clinical studies in 2H14. CNCE expects to initiate the PhII study of CTP-354 in patients with spasticity associated with spinal cord injury later this year. We look forward to top-line data from the PhI portion of this study in October. Regarding, CTP-499, CNCE is well positioned to advance the program into PhIII, following their end of Phase II meeting with the FDA last month. The company is leaning towards a single study with two doses of CTP-499 instead of the other option raised in the meeting of conducting two parallel trials for each dose. CNCE intends on initiating discussion with the FDA regarding PhIII later this year, which will include talks of the possibility to conduct the PhIII under SPA. Regarding the partnered programs, JZP-386 PhI study was initiated last month in a first-inhuman study. The PhI study of CTP-730 is expected to initiate in the fall and AVP-786 is expected to advance into PhII in September. We believe CNCE is advancing well on the clinical front and will achieve its expectation to have up to five compounds in clinical studies by the end of the year.
Concert Pharmaceuticals has begun a Phase I trial with CTP-354 to potentially treat spasticity and chronic pain. Previously, the compound had been Merck & Co.’s L-838417 and had demonstrated strong muscle relaxant activity and efficacy against both inflammatory and neuropathic pain. Despite L-838417’s strengths, the compound showed substantial pharmacokinetic limitations and as a consequence, never made it past the lab.The Concert Pharmaceuticals study will evaluate the safety, tolerability, and pharmacokinetics of CTP-354 in healthy volunteers. In addition, the company intends to conduct a Positron Emission Tomography study to assess brain receptor occupancy of CTP-354 in healthy volunteers. Concert expects to report top-line results of the Phase 1 single ascending dose study by the end of the year. “CTP-354 was a compound that was brought to my attention in a conversation that I was having with an expert in another field,” says Concert Pharmaceuticals CEO Roger Tung. “He had worked preclinically with the compound and had mentioned some results that he had with it as a very exciting agent. Based on that, we went back as an organization to review the available data on it, which is vast. There are a lot of publications on the underlying L-838417, which is the Merck compound. We saw this as an opportunity to apply our technology, to improve certain properties such as distribution, metabolism, and secretion to and to enable this compound to be taken into human clinical evaluation and to do what we hope it will be able to, which is be a unique ground breaking medicine.” Merck was not able to fit all of the similar properties into the compound. “What we were able to do then is to essentially start with the huge investment, the time, and the effort that they put into identifying and nearly got there and then used our technology to put us over the finish line,” Tung told R&D Pharma Business Connect. Concert’s selective incorporation of deuterium in CTP-354 significantly improved pharmacokinetic properties in preclinical models while maintaining the desirable pharmacological activity seen with the earlier generation modulators. “We see a lot of applicability to the technology to many different kinds of situations and that has led to the collaboration that we have had in a corporate sense,” says Tung. “We announced our partnership with Celgene and we think that it has the potential to have a very broad and important impact in a wide range of medicines.”