|
Post by Yelk on Feb 16, 2015 20:42:06 GMT
Slide deck from CEO and Bio Conference last week: content.stockpr.com/tonixpharma/media/437bb08b99d48d6ac1286506d7e8133f.pdfHighlights Upcoming milestones: 2Q 2015 – Begin Phase 3 program in Fibromyalgia 2Q 2015 – Begin Phase 2 study in ETTH 1H 2015 – Update on enrollment, timing of results – Post-Traumatic Stress Disorder - Now have close to $70M cash on hand after the raise two weeks ago - 15.7M o/s - $90M market cap Price of the raise was $5.85, current share price is $5.78, had some pretty good firms who took part in the raise; Broadfin Capital LLC, Deerfield Management Company, L.P., Sabby Management LLC etc... Just to recap, this was a $15 stock a few months ago until it failed P2b for Fibromygalgia. The FDA said that despite the trial failing to meet primary end points, the 30% response rate was in fact significant and gave them the go ahead for P3. I'll likely be adding more on Monday since I think there is a lot of upside, especially at these levels. Funny you are going here today. Our conversation 2 hours ago reminded me of this company and I continued on my DD path to look to add more as well. I think JP's comments on twitter saying $5.70 is the best place to add under the big boys is fair. I want to write my "Phase 2" DD thoughts on this company on a full write up. I'll post it later.
|
|
|
Post by Yelk on Feb 16, 2015 22:12:14 GMT
Tonix Pharmaceuticals (TNXP:US) Catalysts: - P2 Tension Headache start 2Q 2015 (Finish 4Q 2015)
- P3 Start Fibromyalgia 2Q 2015 (Finish 1H 2016)
- P2 PTSD Started – updates on enrollment through 2015 due to military type enrollment (Finish 1H 2016)
- Just finished financing deal of $28.7 Million to have strong financing to see all current projects through
- Insider holdings large; purchases: large, recent and no sells
- Large institutional holdings and expectation of more to come as we enter enrollment
- Stock trading near 52 week low and well below moving averages
- $1+ Billion market potential (conservatively in my opinion)
A simple to understand overview: Tonix Pharmaceuticals name comes from the word “tonic” and in the modern sense is to represent gentle, soothing medicine. Over the last 10-15 years there have been several products to meet the needs of patients with PTSD, Fibromyalgia, and Tension Headache. As noted in the company’s latest presentation ir.tonixpharma.com/investor-presentations this is a massive unmet medical need as the majority of patients admitted into urgent care are actually from Tension Headache and not a migraine. In addition it has been over a decade since there has been any clinical development in the area of PTSD particularly in the military. It is well known that a good night’s sleep improves health. The science behind this company is as sound as it gets in my opinion. While that sounds overly simple with not much backing sometimes our bodies are the best doctor. If you’ve ever been to the doctor the first thing they ask you is how you feel. It is a known fact over what I would assume hundreds of years if you sleep well either when you haven’t been sleeping well or are suffering effects such as a fever or headache you will feel better. These trials can be directly linked to depravity of sleep and more stress on the body. Tension Headache we are looking for an endpoint of relief at 2 hours. TNX-102SLThe first of the three clinical developments and perhaps the largest catalyst as we move towards 2016 will be the P3 Fibromyalgia study with TNX-102SL that will begin in 2Q 2015. I expect enrollment to start in June, but this may happen as early as May. Current treatment for Fibromyalgia is limited to Lyrica, Cymbalta and Savella. P3 will have 500 patients with an endpoint of 30% responder analysis as per FDA direction in early January when the stock soared over 30%. Recently it as trickled down to all-time lows as we await the upcoming catalysts. Back in September 2014 Tonix failed to meet endpoint data for P2 trial. The market overacted and the stock plunged over 50% in a single trading day. The endpoint was average pain score at week 12. What went unnoticed in the chaos was that when examining the data further there was a surplus 30% responder rate. This is statistical improvement over Savella. 30% responder analysis simply means that a patient has as a minimum of 30% pain reduction to count towards the endpoint efficacy. Full data for the P2 trial is expected in June 2015 and has shown as far as we can see a high degree of safety in use with 3% or less small side effects on a small population. Conclusion: Tonix is addressing a hugely unmet need. They have a strong and talented management team with a strong cash position, demonstrated belief with insider buys and in my personal opinion solid science of addressing the core of the problem with sleep improvement. The market potential for TNX-102 SL peak is $600 million (more with secondary use) and $400 million for PTSD. This has been beaten into the ground due to an adjusted endpoint and no short term catalysts. I do not however see the stock being help much longer as we are about to enter 2 major trials next quarter and have updates on the third. This is huge and I expect a TP of $15 by the end of Q4 2015 with positive data on Tension Headache. We then have a run up after that for data of the next 2 trials. I am long in this stock. The risk reward profile at this level shows minimal downside and a maximum potential of a two-three fold increase every year on average for the next 5-9 years if all trails go through successfully. I'd like to point out many of these comments are purely speculative so please do your DD before investing. I will be writing an article on this I think maybe by May with more up to date information as we move into the year with better language , more detail, more statistics and the combined viewpoints of others. Disclosure I have a small position currently and will look to double it on a dip this coming week. Technical analysis: I'd like to note larger negative volume due to financing scare. Volume analysis despite financing shows stabilization of negativity to stock. As demonstrated in multil year history chart this stock is volatile and I think this is a unique opportunity moving forward (will be a slow incline). There is a chance we may decline further on an extremely slow level but at some point before the end of Q2 it will be leaving $5.80 behind.
|
|
|
Post by Yelk on Feb 18, 2015 14:28:25 GMT
09:12 EDT Tonix Pharmaceuticals shares significantly undervalued, says Roth Capital Roth Capital believes that Tonix's stock is significantly undervalued, given the status of its three clinical stage drug programs. The firm thinks that the company now has enough cash to obtain pivotal trial data for its key fibromyalgia program. Roth increased its price target on the stock to $12 from $10 to reflect its increased confidence that the company's TNX-102 drug will be approved. Roth reiterates a Buy rating on the shares.
|
|
|
Post by JHam on Feb 18, 2015 15:11:14 GMT
09:12 EDT Tonix Pharmaceuticals shares significantly undervalued, says Roth Capital Roth Capital believes that Tonix's stock is significantly undervalued, given the status of its three clinical stage drug programs. The firm thinks that the company now has enough cash to obtain pivotal trial data for its key fibromyalgia program. Roth increased its price target on the stock to $12 from $10 to reflect its increased confidence that the company's TNX-102 drug will be approved. Roth reiterates a Buy rating on the shares. Nice to see, but Roth were the ones who underwrote the recent deal, so there's no mystery on that one, lol.
|
|
|
Post by JHam on Feb 18, 2015 15:25:24 GMT
Now this from Jason Napodano:
Jason Napodano, CFA @jnapodano 3m3 minutes ago I actually agree with Roth (eek). I think $TNXP is undervalued right now and should be trading at $10-12 per share.
|
|
|
Post by JHam on Feb 18, 2015 15:38:50 GMT
Just doubled my position at $5.88. Averaged at $5.83. Anything under $6.00 is a bargain in my opinion. May add more if it goes below my cost average.
|
|
|
Post by forthefuture on Feb 18, 2015 16:19:49 GMT
|
|
|
Post by Yelk on Feb 18, 2015 19:33:30 GMT
Just doubled my position at $5.88. Averaged at $5.83. Anything under $6.00 is a bargain in my opinion. May add more if it goes below my cost average. Good call JHam looks like today may have been the last day under $6 . I'll be looking for a dip.
|
|
|
Post by JHam on Feb 18, 2015 19:55:51 GMT
Just doubled my position at $5.88. Averaged at $5.83. Anything under $6.00 is a bargain in my opinion. May add more if it goes below my cost average. Good call JHam looks like today may have been the last day under $6 . I'll be looking for a dip. Looks like I got in just in time. On the move now.
|
|
|
Post by JHam on Feb 18, 2015 20:04:52 GMT
Thanks for posting this forthefuture. I'll have a look in the morning and let you know.
|
|
|
Post by forthefuture on Feb 18, 2015 20:18:09 GMT
|
|
|
Post by JHam on Feb 19, 2015 14:54:04 GMT
Just added what is likely my final tranche in this one at $6.23. Higher than what I wanted to pay, but I still believe this is really undervalued at this point so what the heck. New average is $5.92, $.07 higher than the recent offering so not too bad.
|
|
|
Post by JHam on Feb 25, 2015 0:27:15 GMT
OK I lied. I put in an order for one last small buy at $6.07 and before I went to bed and low and behold it filled. Now have a medium sized position in this and unless it goes under my cosy average I am done buying...probably
|
|
|
Post by Yelk on Feb 25, 2015 0:48:50 GMT
OK I lied. I put in an order for one last small buy at $6.07 and before I went to bed and low and behold it filled. Now have a medium sized position in this and unless it goes under my cosy average I am done buying...probably I thought about it all day... couldn't bring myself to put in anymore so far away. But that's what everyone is thinking. I'll probably regret it. But if it is down or even tomorrow I won't have a choice but to give in lol. Position is still small here.
|
|
|
Post by JHam on Feb 25, 2015 7:24:27 GMT
Interview with the CEO and CFO of Tonix. The interviewer is a little bit tough to watch/listen to, lol, but both Lederman and Gershell are very good. Some new info here too on the upcoming P3. Trial name will be AFFIRM (P2 was BestFit) and they are looking to enroll twice as many patients this time (500) at twice as many sites (35). Trial enroll to begin in 2Q 2015 with final results set for 3Q 2016. Very good info from 6:30 -9:00. Liking this company more and more, especially at these levels. It is my "FOLD" for 2015-2016: streetexclusive.com/2015/02/24/tonix-pharmaceuticals-ceo-and-cfo-join-us-in-studio/
|
|
|
Post by JHam on Feb 25, 2015 10:57:24 GMT
Just as a quick review. TNXP failed the BestFit P2 study when it did not show statistical significance in the primary efficacy endpoint of change in average daily pain score at week 12. However, they did observe statistical significance in every other end point, including patients who experienced a 30% improvement in their pain scores.
The FDA agreed that the 30% improvement in pain was significant and has allowed TNXP to make that the primary end point in the upcoming AFFIRM P3 trial. So basically, now TNXP just has to prove that they can repeat that 30% improvement in pain over a larger number of patients to meet the primary end point in P3. NRIFF has taught me that there is no such thing as a sure bet, but if it worked in 200 people I feel fairly comfortable that they can prove it works in 500 as well.
This stock was trading between $13-$15 before P2 failed and it plummeted down to the mid-$5s. Since then the FDA has agreed that P2 results were clinically significant and given them the go ahead for P3, and TNXP has bolstered their cash situation to almost $70M. If it was worth $13-$15 before, then it doesn't make sense for it not to be valued around the same levels now, imo, as nothing has changed for the worse and you could even argue that things have changed for the better. At $6, I am very bullish on this one right now (if you can't tell, lol) as a value play.
As always, any hole punching in my analysis is appreciated.
|
|
|
Post by JHam on Feb 25, 2015 14:39:25 GMT
Doh! I should retract my statement about how it should be valued at the "same levels" now as I forgot to do the math and adjust numbers after dilution:
Pre-dilution: 10.8M shares outstanding 1 YR high: $15.46 or $167M market cap
Post dilution: 15.7M shares outstanding (4.9M issued in the offering) Post dilution adjusted share price based on a $167M market cap: $10.63
$9-$10 is still very undervalued, and that is still before any positive news being factored in from their trials.
|
|
|
Post by JHam on Feb 25, 2015 14:43:27 GMT
Incidentally, just to give you some market numbers for Fibromyalgia. Pfizer's biggest drug on the market, Lyrica for Fibromyalgia, is set to eclipse $1B in sales. Right now it is the only alternative to lumbar spinal infusions. TXN 102-SL is not only a simple pill, but is also much safer that Lyrica. TXN 102-SL has experienced no safety issues other than occasional temporary numbness of tongue. Compared to this list of safety issues from Lyrica. Good god I wouldn't take Lyrica if my life depended on it:
IMPORTANT SAFETY INFORMATION & INDICATIONS
LYRICA is not for everyone. LYRICA may cause serious, even life threatening, allergic reactions. Stop taking LYRICA and call your doctor right away if you have any signs of a serious allergic reaction. Some signs are swelling of your face, mouth, lips, gums, tongue, throat or neck or if you have any trouble breathing or have a rash, hives or blisters.
Drugs used to treat seizures increase the risk of suicidal thoughts or behavior. LYRICA may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Patients, family members or caregivers should call the doctor right away if they notice suicidal thoughts or actions, thoughts of self harm, or any unusual changes in mood or behavior. These changes may include new or worsening depression, anxiety, restlessness, trouble sleeping, panic attacks, anger, irritability, agitation, aggression, dangerous impulses or violence, or extreme increases in activity or talking. If you have suicidal thoughts or actions, do not stop LYRICA without first talking to your doctor.
LYRICA may cause swelling of your hands, legs and feet, which can be serious for people with heart problems. LYRICA may cause dizziness and sleepiness. You should not drive or work with machines until you know how LYRICA affects you. Also, tell your doctor right away about muscle pain or problems along with feeling sick and feverish, or any changes in your eyesight including blurry vision or if you have any kidney problems or get dialysis.
Some of the most common side effects of LYRICA are dizziness, blurry vision, weight gain, sleepiness, trouble concentrating, swelling of your hands and feet, dry mouth, and feeling “high.” If you have diabetes, tell your doctor about any skin sores. You may have a higher chance for swelling and hives if you are also taking angiotensin converting enzyme (ACE) inhibitors so tell your doctor if you are taking these medications. You may have a higher chance of swelling of your hands or feet or gaining weight if you are also taking certain diabetes medicines. Do not drink alcohol while on LYRICA. You may have a higher chance for dizziness and sleepiness if you take LYRICA with alcohol, narcotic pain medicines, or medicines for anxiety.
Before you start LYRICA, tell your doctor if you are planning to father a child, or if you are pregnant, plan to become pregnant, or are breast-feeding. If you have had a drug or alcohol problem, you may be more likely to misuse LYRICA.
In studies, a specific type of blood vessel tumor was seen in mice, but not in rats. The meaning of these findings in humans is not known. Do not stop taking LYRICA without talking to your doctor. If you stop suddenly you may have headaches, nausea, diarrhea, trouble sleeping, increased sweating, or you may feel anxious. If you have epilepsy, you may have seizures more often.
|
|
|
Post by RLC on Feb 25, 2015 15:32:31 GMT
Incidentally, just to give you some market numbers for Fibromyalgia. Pfizer's biggest drug on the market, Lyrica for Fibromyalgia, is set to eclipse $1B in sales. Right now it is the only alternative to lumbar spinal infusions. TXN 102-SL is not only a simple pill, but is also much safer that Lyrica. TXN 102-SL has experienced no safety issues other than occasional temporary numbness of tongue. Compared to this list of safety issues from Lyrica. Good god I wouldn't take Lyrica if my life depended on it: IMPORTANT SAFETY INFORMATION & INDICATIONS
LYRICA is not for everyone. LYRICA may cause serious, even life threatening, allergic reactions. Stop taking LYRICA and call your doctor right away if you have any signs of a serious allergic reaction. Some signs are swelling of your face, mouth, lips, gums, tongue, throat or neck or if you have any trouble breathing or have a rash, hives or blisters.
Drugs used to treat seizures increase the risk of suicidal thoughts or behavior. LYRICA may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Patients, family members or caregivers should call the doctor right away if they notice suicidal thoughts or actions, thoughts of self harm, or any unusual changes in mood or behavior. These changes may include new or worsening depression, anxiety, restlessness, trouble sleeping, panic attacks, anger, irritability, agitation, aggression, dangerous impulses or violence, or extreme increases in activity or talking. If you have suicidal thoughts or actions, do not stop LYRICA without first talking to your doctor.
LYRICA may cause swelling of your hands, legs and feet, which can be serious for people with heart problems. LYRICA may cause dizziness and sleepiness. You should not drive or work with machines until you know how LYRICA affects you. Also, tell your doctor right away about muscle pain or problems along with feeling sick and feverish, or any changes in your eyesight including blurry vision or if you have any kidney problems or get dialysis.
Some of the most common side effects of LYRICA are dizziness, blurry vision, weight gain, sleepiness, trouble concentrating, swelling of your hands and feet, dry mouth, and feeling “high.” If you have diabetes, tell your doctor about any skin sores. You may have a higher chance for swelling and hives if you are also taking angiotensin converting enzyme (ACE) inhibitors so tell your doctor if you are taking these medications. You may have a higher chance of swelling of your hands or feet or gaining weight if you are also taking certain diabetes medicines. Do not drink alcohol while on LYRICA. You may have a higher chance for dizziness and sleepiness if you take LYRICA with alcohol, narcotic pain medicines, or medicines for anxiety.
Before you start LYRICA, tell your doctor if you are planning to father a child, or if you are pregnant, plan to become pregnant, or are breast-feeding. If you have had a drug or alcohol problem, you may be more likely to misuse LYRICA.
In studies, a specific type of blood vessel tumor was seen in mice, but not in rats. The meaning of these findings in humans is not known. Do not stop taking LYRICA without talking to your doctor. If you stop suddenly you may have headaches, nausea, diarrhea, trouble sleeping, increased sweating, or you may feel anxious. If you have epilepsy, you may have seizures more often.
As always, thanks for all the info JHam! I opened a decent position about a month back after I saw little to no PPS appreciation after the company announced the FDA was allowing them to move forward with their with Phase 3 for their Fibromyalgia program (which you or LCD had brought to my attention). I'll likely look to add to this position as I move money out of CUR and ATHX in the coming months...
|
|
|
Post by Yelk on Feb 26, 2015 2:26:40 GMT
Ack. Almost bought on this dip today - I think that is the lowest we may ever see it Was almost $5.x at one point. My sentiments exactly RLC about money from other stocks to here ASAP before this starts trending.
|
|