Das ist schon seltsam…da veröffentlichen die den erfolgreichen Abschluss von gleich zwei Phase 2 Studien und den Übergang in die Phase 3 für ihr Hauptprodukt Rezafungin und der Kurs schmiert ein Woche lang gnadenlos ab… Cash Probleme sehe ich für 2018 nicht mehr, daher kann ich mir beinahe nur vorstellen, dass die für eine Übernahme sturmreif geschossen werden. Hauptverdächtiger ist hier für mich Merck, die mit ihrem Konkurrenzprodukt caspofungin weniger gut dastehen als Cidara. Das Potential von Rezafungin halte ich jedenfalls gerade im Bereich der Profilaxe von unerwünschten Nebenwirkungen bei Knochenmarkspenden für gigantisch, weil Rezafungin nur einmal wöchentlich ambulant gegeben werden muss, während alle Konkurrenten die permanente Gabe im Rahmen eines klinischen Aufenthalts verlangen. Bei einer Marktkapitalisierung von jetzt nur noch 85 Mio $ sind die in meinen Augen ein echtes Schnäppchen (alleine die Immuntherapie Entwicklungsplattform Cloudbreak sollte erheblich mehr wert sein, hinzu kommen noch 75 Mio $ cash). Ich greife mal ins fallende Messer…
Cidara Should Be On Your Radar After Positive Phase 2 Despite The Drop In Share Price
Mar.20.18 | About: Cidara Therapeutics (CDTX)
Positive phase 2 data bodes well for Cidara, because it can advance two phase 3 studies with its anti-fungal medicine rezafungin.
Rezafungin posted positive trends in clinical outcome compared to Merck's caspofungin which bodes well for the phase 3 studies.
The financials are good for now, but it is highly likely that Cidara will have to raise cash by the end of 2018.
Cidara Therapeutics (CDTX) announced recently that its drug candidate rezafungin acetate met the primary endpoint for a phase 2 study treating patients with candidemia and/or invasive candidiasis. The stock traded lower by 20% and was sold off. However, the data in question is highly positive. There was no rational reason for the sell off, and I believe that the stock is a good buy. Especially, since Cidara is on track to begin two phase 3 studies for its rezafungin acetate clinical candidate in 2018. That develops two paths for this clinical candidate, which is why I believe the selloff in the stock is way overdone.
The phase 2 trial, known as the STRIVE trial, recruited a total of 104 patients with systemic Candida infections (Candidemia). This trial was split into three different dosing arms. Group 1 of the study took 400 mg of rezafungin administered intravenously once weekly for two to four weeks. Group 2 took 400 mg of rezafungin for the first week followed by 200 mg once weekly for up to four weeks. The comparator arm used once daily caspofungin administered intravenously for the same time period. It is important that I note that those patients who were on caspofungin had the option of stepping down to oral fluconazole. Another quick thing that I should note is that Caspofungin is an antifungal treatment produced by Merck (MRK). The trial was highly positive, because there were consistent trends of an improvement of clinical outcomes observed in patients who took rezafungin treatment compared to those who took the comparator caspofungin. An important thing to note was that the study was not powered to determine superiority or non-inferiority of rezafungin to caspofungin. Still, that doesn't detract from the positive trends that were observed in the phase 2 study. In addition, Cidara is gearing up to initiate two phase 3 trials targeting two different populations. If the trial data was not positive, then it would not be possible for the company to initiate two phase 3 studies.
Cidara is pushing to initiate two phase 3 studies in two big populations. The first of which is for candidemia. This phase 3 study is expected to recruit up to 150 patients with candidemia. The trial is expected to be the same design as the STRIVE trial, but will use a different primary endpoint of 30-day all-cause mortality. In my opinion, with the positive trends observed in the phase 2 study in terms of overall mortality, I have no doubt that this primary endpoint can be met in the phase 3 study. That's because GROUP 2 for the STRIVE trial had the least incidents in mortality compared to the other groups. The second phase 3 study will test the ability for a 90-day treatment of rezafungin to block fungal infections in patients that undergo an allogenic bone marrow transplant. This trial will test rezafungin as a preventative measure, and the primary endpoint will be fungal-free survival. Both of these phase 3 studies are likely to be major catalysts for the stock. However, it will be a few years before we see data from either of these studies. Topline data for both of these studies are expected by 2020. In the meantime, I believe that the positive phase 2 data from the STRIVE study will carry the stock higher in the coming weeks.
Cidara Therapeutics has cash, cash equivalents and short-term investments of $75.3 million as of December 31, 2017. This total includes the private placement that was completed in October of 2017. That is when Cidara sold 3,360,000 shares of its common stock at a price of $6 per share. Cidara raised a total of $20 million for the private placement. According to the company it has enough cash resources to fund its operations for at least the next 12 months. That means that the company should be okay for the time being, especially since it just raised cash this past October in 2017. I believe that there is a possibility that it could raise cash sometime toward the end of 2018 again.
The positive phase 2 data is very bullish. Not only did Cidara beat the endpoint of the study, but it also noted that it was going to branch out its clinical candidate rezafungin towards two phase 3 studies. I believe that this provides the basis to boost the value of the stock. It is not clear sailing though with rezafungin, because it is highly likely that the phase 3 study will be very important for the company's future. Not just because of how well the data performed, but its because a comparison will be made between rezafungin and Merck's caspofungin as soon as the results are read out for the phase 3. It will be a show of which drug performs better in its respective patient population.
Quelle: Seeking Alpha
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Wieder einmal zeigt sich: Die fetten Deals im Biotech-Sektor werden genau dann gelandet, wenn die Stimmung nahe Tiefpunkt ist: Cidara Therapeutics (WKN: A14R2R) verlor im Laufe des letzten Jahres....