Tocagen's Upswing, And Other News: The Good, Bad And Ugly Of Biopharma
- Tocagen's merger-fueled upswing continues.
- Milestone Pharma declares full year earnings.
- Ardelyx plans to file its Tenapanor application by mid-2020.
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Tocagen Continues Merger-Fueled Upswing
Tocagen (TOCA) stock shot up as the company follows through its previous announcement about a merger with Forte Biosciences, an obscure pharmaceuticals firm with FB-401 as its lead candidate. FB-401 is a topical drug designed to treat inflammatory skin conditions. The drug is claimed to have shown promise during its Phase 1/2 study. The results from the study are expected to be published during mid 2020. It is also expected that a Phase 2 trial for evaluating the impact of this drug candidate on treating atopic dermatitis will be launched towards the middle of this year. The top line data will likely be out during the middle of the next year.
Tocagen has a tumultuous history behind it. The stock suffered massive loss when its trials assessing the effectiveness of Toca FC and Toca 511 failed to meet the mark. The trial failed to achieve the primary endpoint of overall survival compared to standard-of-care treatment (median of 11.1 months vs. 12.2 months; hazard ratio: 1.06; p=0.6154). The secondary endpoints of the trial also failed to show any significant differences between the treatment arms. The aftermath of trial failure led to the company sacking nearly two thirds of its employees.
The merger is expected to be finalized in the second quarter of the year. Tocagen CEO Marty Duvall said, “The strength and dedication of the Forte leadership team, combined with their highly differentiated technology platform and enthusiastic support from leading clinicians, provides a compelling foundation for future success for all stakeholders, and they have our full support."
Forte Biosciences is currently privately held and post-merger, the combined entity will be listed on Nasdaq Capital Market under a new ticker. Toca shareholders will gain a quarter of the resulting company, which will work under the leadership of Forte’s current CEO Paul Wagner. Forte has some prominent private investors on board such as OrbiMed and BVF Partners which are expected to pump in nearly $14 million. The cash infusion is expected to be used for funding a randomized Phase 2 study of FB 401.
Milestone Pharmaceuticals Reports Full Year And Q4 Numbers
Milestone Pharmaceuticals Inc. (MIST) provided its financial and operational results for the fourth quarter and for the entire financial year. The company also offered corporate updates about its various activities. Milestone’s operational loss for the fourth quarter stood at $18.9 million, up from $10.1 million in operational loss it had reported for the corresponding quarter of the previous year. For the full year, the company suffered an operating loss of $57.9 million, up from $23.8 million on a year over year basis.
Milestone Pharmaceuticals reported spending $14.1 on research and development endeavors during the fourth quarter while its full year tally stood at $42 million. The corresponding figures for the previous year were reported at $7.3 million and $16.8 million respectively. General and administrative expenses for the fourth quarter and the entire year were reported at $2.3 million and $7 million respectively. Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals said, “As we focus on topline results from NODE-301, we remain diligent in executing on the balance of our Phase 3 program of etripamil for PSVT, including the NODE-302 and NODE-303 safety studies.” The company expects to announce its top line data from NODE 301 trial later this month.
Milestone also announced that it has initiated the enrollment process for its NODE 303 trial and the first patient was inducted in October last year. The trial is designed to test the safety of etripamil when it is self-administered without any medical supervision during single or multiple SVT episodes. The trial is expected to have up to 3,000 patients.
Ardelyx Inc. To File Tenapanor Application And Reports Q4 Results
Ardelyx Inc. (ARDX) announced that it plans to file its Tenapanor application by the mid of this year. The drug candidate is designed to control serum phosphorus and is already approved for treating irritable bowel syndrome with constipation. The FDA approval for this condition came through in September last year. The company has entered into various collaborations such as with Kyowa Kirin Company Limited in Japan, Fosun Pharma in China and Knight Therapeutics in Canada for the commercialization of the drug.
Ardelyx also reported its fourth quarter and full year results. The company reported its total revenue for the year at $5.3 million while its previous year revenue stood at $2.6 million. Its research and development expenses for the year were at $71.7 million, up from $69.4 million it had spent in the previous year. Ardelyx’s net loss for the year was reported at $94.9 million, in comparison to a net loss of $91.3 million it had incurred during the previous year.
Ardelyx provided corporate updates as it reported that its Phase 3 AMPLIFY study providing statistically significant results. The company also stated that it has expanded its collaboration with Kyowa Kirin Co. Ltd. and has included a research agreement as well as a $20 million equity investment to the portfolio. Mike Raab, president and chief executive officer of Ardelyx said, “We enter 2020 well-positioned with data from three successful Phase 3 trials for tenapanor in hyperphosphatemia, key ex-U.S. partnerships and two years of cash on hand to prepare for U.S. commercialization of our novel therapy." The company also raised nearly $135 million through an underwritten public offering.
The company has a robust development pipeline with RDX011 which is currently being tested for cardiorenal indication while RDX013 is under investigation for multiple indications such as Hyperkalemia and GI.
Ardelyx is now looking forward to submit its Tenapanor application during the middle of the year. It is in Phase 3 trial for treating Hyperphophatemia which is generally seen in patients suffering from end-stage renal disease. This condition shows various characteristics such as build-up of excessive phosphorus, causing various heart and bone diseases. Generally, this condition is treated by administering a combination of oral phosphate binders, requiring patients to ingest a large number of pills. Tenapanor seeks to be a twice a day pill treatment for this condition, thus reducing the pill burden.
The pharma company provided guidance for 2020 as well. Ardelyx stated that its liquidity is enough to sustain its operations until early 2022. The company is currently working on a number of trials and has a couple of milestones coming up. Its stock showed strong performance in the stock market as it gained close to 100 percent in the past 12 months. However, the stock’s Year to Date performance is a little wobbly as it lost 15 percent of its value. This decline also provides a good opportunity to build a position in the stock with a medium to long-term time horizon.
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