As we forge forward through the second half of 2019, many of the catalysts that once seemed over the horizon draw nearer. Here is my list of notable readouts from companies that I follow and/or are on my watch list.
Calithera (CALA) – I view Calithera as an undervalued biotechnology company. With a pipeline of self-made candidates, Calithera stock price has great upside potential and limited downside potential in my eyes. On September 29th, we will get a first look into the arginase inhibitor INCB001158 alone and in combination with pembrolizumab in the form of a proffered paper session at ESMO 2019 in Spain. INCB001158 is being developed in combination with Incyte, for which Calithera will split be responsible for/receive 40% of losses or profits related to any sales of INCB001158. I am expecting a mixed bag of results for this readout. I do not have high hopes for the monotherapy arm, as I anticipate the most favorable results to be from the combination arm. The preclinical and initial biomarker results were positive, but this readout will be the first time we see tumor response data. As such, the main risk here is the paucity of past data to analyze.
AVEO Oncology (AVEO) – Potentially one of the highest risk/reward readouts is AVEO’s TIVO-3 overall survival analysis for their lead candidate tivozanib. This data set very likely will determine the fate of the company. A positive result will likely solidify the ability for AVEO’s licensee EUSA to continue to market the drug in the Europe, while paving the road the AVEO to file for approval in the United States. Should the results not return favorable, AVEO will be left with limited options for tivozanib and the EMA will likely revoke the marketing decision for tivozanib in Europe. AVEO will have plenty of cash to keep the lights on, but very limited meaningful pipeline candidates in the near-to-mid term to get investors excited about. AVEO has reported what I interpret to be the following time-line: initiation of analysis in August 2019 (past but not announced), followed by sharing the results in the fourth quarter of 2019.
Seattle Genetics (SGEN) – Seattle Genetics has been touting the expectation for results of their pivotal Phase3 trial HER2CLIMB. HER2CLIMB is the phase 3 trial evaluating Seattle Genetic’s oral small molecule inhibitor tucatinib (purchased as part of the Cascadian deal) in HER-2 positive breast cancer. These results will include the progression-free survival analysis, which could come at any time as Seattle Genetics has been referring to the upcoming results for almost the entirety of 2019. Seattle Genetics is much larger and more mature than the two previous biotechnology companies, however a positive result would unlock a large market for Seattle Genetics. Should the results not pan out, Seattle Genetics has many other opportunities, many already being commercialized, to continue growing behind.
Other notable readouts that I am anticipating, but may not be as discussion worthy as those above in my eyes include the following:
Verastem Oncology (VSTM) – I am anticipating some updates later this year with regards to the peripheral T-cell lymphoma program. Ideally, ASH conference in December would be the appropriate venue for this. PTCL, if successful, will likely be the larger indication for Verastem’s duvelisib as opposed to the current CLL/CLL indication.
Delmar Pharmaceutical (DMPI) – Nano-cap Delmar is trying to make a big splash in the oncology world by developing a therapy for one of the most difficult to treat cancers: glioblastoma. After recent funding, DelMar has strengthened the balance sheet ahead of their Phase 2 update(s) in late November at the Society of Neuro-Oncology meeting.
This article serves to help investors and traders develop a plan ahead of upcoming catalysts. Should a company spark your interest, please comment below with your thoughts and we may do a deeper report on the company!
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I/we long CALA and DMPI, and reserve the right to buy/sell other mentioned stocks within the next 48 hours.
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