Pareto released last week report Nordic Healthcare Triggers for October.
I select the most interesting ideas from the report and copy the main statements plus my comments.
Biovica
Biovica is my top pick in the Nordic Healthcare. Who follow this blog saw how we doubled money on Xbrane. Biovica is very similar case and it has the same potential to double during the next quarter as Xbrane did.
The investment thesis is similar to Xbrane:
- Biovica has 12 studies, including the most prominent US HOspitals ( Mayo, Cleveland ), that show their cancer detection product works
- FDA is due to approve the product in Q4.
- The company announced that it would start selling the product in Q4, shortly after the approval
- Pharma companies that have a major milestone in a near future achieve significantly share price appreciation. Xbrane doubled in two months on positive Phase 3 data study expectation. Biovica is the same situation
- The 12 study from best hospitals reduces risks for FDA approval. Pareto believes that there is 95% likelihood of FDA approvment.
- Biovica is a perfect candidate to double in the next 2-3 months.
Detailed investment thesis:
https://seekingalpha.com/article/4437698-biovica-international-should-double-on-novel-breast-cancer-test-launch-in-q3
ABG and Redeye research are available at Biovica website:
Introduce.se – Biovica – Take-aways from Capital Markets Day
Biovica: Q4 confirms that the FDA approval is on track (redeye.se)
Biovica: DiviTum to Stir Some Blood (redeye.se)
Pareto Nordic Healthcare triggers comment:
Biovica – PAS rating: Buy, TP SEK 103
FDA’s handling delayed, call with CEO
Biovica today announced that there has been a delay in response from the FDA. In a call with the CEO this morning, it was confirmed that nothing new came up but that it is just an FDA-related delay. After
the last meeting with the FDA, the company received the meeting minutes and prepared an answer based on all requests with minor questions surrounding the intended use to be discussed interactively (a
point where a company usually aims for wider claims and the regulators wanting everything backed by data / keep the intended use narrow). These are detailed questions/negotiations surrounding the
broadness of the intended use and there have been no questions anymore regarding predicate device, this has been solved early on. The FDA however has not come back yet on these intended use details, so
the company is still waiting for them to ensure the best possible outcome of the submission/widest possible intended use for DiviTum. Based on these insights, we see no increased risk of a rejection of Biovica’s submission. As previously communicated, we expect approval before end of October, with
additional delays depending on COVID-19 related regulatory workload for the FDA. We reiterate our
rating on BIOVIC with a target price of SEK 103.
Vicore Pharma – PAS rating: Buy, TP SEK 97
VIcore is a new position for me. I will write about the thesis in next days. I recommend everybody to start a research on this. Below is Pareto comment:
- On 17 September, the company announced that the first Covid-19 patient had been dosed in the phase lll study ATTRACT-3. The pivotal phase lll trial is currently approved in the US, Ukraine, South Africa, Brazil, Czechia, the Philippines and India. The study will include 600 adult patients hospitalised with Covid-19 requiring oxygen support but not mechanical ventilation. The primary objective is to evaluate the effect of C21 on recovery from Covid-19. Patients will be randomised to receive 100 mg C21 or placebo twice daily on top of standard of care for 14 days and be followed for 60 days. Trial start-up activities are ongoing at more than 40 clinical sites globally. Topline results are expected during the first half of 2022. Read the PR here. Read our comment here.
- On 22 September, the company announced that it had obtained a SARS coronavirus patent for C21 in the USA. This new patent gives Vicore patent protection in the US market until December 2040. Read the PR here and our comment here.
Bioinvent
BioInvent – PAS rating: Buy, TP SEK 115
Bioinvent is a new position for me. I will write about the thesis in next days. I recommend everybody to start a research on this. Below is Pareto comment:
Awaiting 4 catalysts with a sp dragged down by peers
We see a unique and short-lived discount to BioInvent’s share price. The share price has been impacted by the expectations for BI-1206+Rituximab dose expansion data in Non-hodgkins lymphoma (NHL) in late summer (delayed to December) and by issues of three close Swedish oncology peers Isofol (down -60% YTD), Cantargia (down -60% YTD) and Oncopeptides (down -80% YTD). We see large differences between these companies and BioInvent. Without going into too many details, both Oncopeptides and Isofol are based on an old chemotherapy and each have only one drug candidate in clinics, which is also true for
Cantargia, which develops one novel antibody that is facing issues with side effects. BioInvent in contrast, has 3 novel antibodies in 4 clinical programs and is expected to have 5 antibodies in at least 6
programs by end of 2022. Further, BioInvent established strong clinical proof of concept (PoC) for its lead drug BI-1206 in NHL in January 2021 – showing good safety and efficacy. Based on insights from
Tislelizumab, an anti-PD-1 checkpoint inhibitor with Fcγ interaction-minimizing properties, we are confident that BI-1206+Pembrolizumab (Keytruda) will have an effect in the much bigger area of solid
tumours. BioInvent is expected to deliver 4 catalysts over the coming 7 months. These include clinical data from BI-1206 in NHL and in solid tumours (the biggest near-term catalyst due to larger market size)
in December. Further, data from BI-1808 (first TNFR-2 antibody in clinics) and BT-001 in solid tumours are expected in Q1 2022. The current low valuation renders it enough that BioInvent succeeds with only one of the four programs to increase the share price. While the market seems to be unable to value the company, global biotech specialist funds head up the shareholder list and funded the company with SEK 1.5 bn in the bank as of end of Q2 (mcap SEK 2.3bn). For more information, please consult our latest update. We believe that the company will leave these lows latest in December and thereafter not re-visit them and thus re-iterate our Buy rating with a target price of SEK 115.
Ascelia Pharma
Ascelia is a new position for me. I will write about the thesis in next days. I recommend everybody to start a research on this. Below is Pareto comment:
- On 21 September, the company announced that it had signed a clinical collaboration agreement with Taiho Oncology Inc., a subsidiary of Taiho Pharmaceutical Co. Ltd. The collaboration concerns an upcoming global phase ll clinical study in gastric cancer. In this study, Ascelia´s Oncoral will be evaluated in combination with Taiho Oncology´s Lonsurf®, i.e., this will be an all-oral combination study. As part of the agreement, Taiho will supply Lonsurf® as well as scientific expertise for the study. Depending on the results, the collaboration may be extended for further development of the two agents. The phase ll study is planned to start in H2 2021 and will include approximately 100 patients with metastatic gastric cancer. The initial portion of the study will be conducted at hospitals and clinics in Europe. Read the PR here.
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