Brussels has said a block on Russian coal exports will be part of an upcoming fifth sanctions package that is currently being discussed by EU member states.
Further the coal price in Q4 did not reflected the Russia coal ban.
The stock is very cheap today. If the Russian coal happen this stock could easily triple. It would still trade below 4 EV/EBITDA on Q4 numbers.
Disclosure: The goal of the blog is to provide investment ideas for further research. I/we have a beneficial position in the shares discussed above either through stock ownership, options, or other derivatives. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article. The article does not represent investment advice. Please do your own research before making any investment action.
I wrote here several times about COOL Co. First time when share price was around 75 NOK about five weeks ago. It is 105 today. Today ABG came out with PT of 154NOK. I remain very bullish on COOL for reasons I wrote before.
A pure LNG shipping company We believe rates could see all-time highs next winter Initiating coverage with BUY, TP of NOK 154
A pure LNG shipping company Cool Company Ltd. (CoolCo) is a pure-play LNG shipping company that owns and operates eight TFDE LNG carriers. The company aims to become a leading player in LNG shipping through consolidation opportunities and offering investors pure exposure to the shipping of liquified natural gas. It aims to keep the fleet exposed to the spot market, and to commit to longer-term time charters when prevailing market rates are deemed favourable. Eastern Pacific Shipping and Golar LNG are the two main shareholders, with stakes of 38% and 31%, respectively.
Gas forward curve yield new ATH for LNG rates in ‘23e Global liquefaction capacity is expected to increase substantially in the coming years and recent events such as the Russian invasion of Ukraine and the EUs acceptance of gas as “sustainable” will likely add even more investments. We expect fleet utilisation above 90% already this year, and as the gas forward curve yields more than USD 1m/day in TCE, we believe rates could hit all-time high next winter. We model for a rate for a 160k TFDE to increase to USD 90k/day in ‘22e, up from an average of USD 87k/day in ’21. Further, we expect the tightening of the LNG shipping market to yield rates of 146k/day in ‘23e and 138k/day in ‘24e, again assuming that European and Asian gas prices remain well above the US price. As such, we model for avg. EBITDA in ’22-‘24e of ~USD 200m, which results in a 36-40% dividend yield in ’23-‘24e.
Initiate with BUY, TP of NOK 154 We initiate our coverage with a target price of NOK 154, derived from a 10% discount to our estimated one-year forward NAV. The forward NAV valuation methodology is based on estimating future asset (vessel) values from forecasted freight rates, which in turn is based on our proprietary supply and demand model. With a limited number of peers in the LNG shipping space, we argue that asset-based valuation is the most applicable pricing method for CoolCo despite modest liquidity in the second-hand market for LNG carriers.
Disclosure:
The goal of the blog is to provide investment ideas for further research. I/we have a beneficial position in the shares discussed above either through stock ownership, options, or other derivatives. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article. The article does not represent investment advice. Please do your own research before making any investment action.
COOL is one of my top picks to play EU diversification of gas supplies away from Russia. I first wrote here about COOL a month ago when it was trading at 75NOK. It is 95 NOK now. Fearnley says: COOL remains one of the few and best plays on these improving market conditions. They increased their price target from 105NOK to 130 NOK, just three weeks after their initial report. There will be further re-rating. The share price move should remain rapid.
Fearnley Research Summary:
Materializing on Improving LNGC Market
Our take: Likelihood of capitalizing on strengthening fundamentals, revising TP on period market outlook. Reiterate Buy, TP lifted to NOK 130 (NOK 105).
The LNGC market is playing into the hands of COOL with increasing expectations both for prompt and time-charters as political focus on energy diversification and securing supply intensifies. COOL remains one of the few and best plays on these improving market conditions (see our initiation report March 9th).
We see increased likelihood for COOL to lock in strong earnings for its open positions over the coming months and reiterate our Buy rating while revise our (base case) TP to NOK 130 (Buy, NOK 105 March 29, 2022) reflecting USD 100k/d rates for two open positions in 4q22 (in addition to the USD 120k/d TC previously reported in the market). This underscores the operational leverage and further potential in the platform, while appetite for modern tonnage and rising steel values reduces downside risk.
Freight rates and operational leverage Period rates for modern vessels continue to improve with TFDEs now quoted at USD 102.5k/d for 1-year durations followed by 3-year duration at USD 85.5k/d. COOL being one of few with open capacity to the improving market could by locking in the two vessels (opening in 4q22) at USD 100k/d generate additional USD 0.4/s EPS for 2023. Given the rumored (TW) 1 year fixture at USD 120k/d and current market assessment, we argue the 100k level to be on likely and on the conservative side.
Earnings focus over NAV into potential high-cycle We argue NAV lags price development as we head into a potential high-cycle and see earnings as a more appropriate metric to capture current earnings prospects. This is further backed by multi-year charters also seeing strong developments. Rising steel values and limited yard capacity through 2026 (at least at current NB prices) also reduce downside risk together with clear charter preference for modern tonnage. We estimate NAV at NOK 85/sh. and have increased our 2022 EBITDA estimates by 12% and 2023 EBITDA by 18%. Including the two additional TCs we see avg. EPS at USD 2.2/sh over ‘22/’23 which at 7x earnings reflect the NOK 130 TP.
FEARNLEY SECURITIES ACTED AS JOINT LEAD MANAGER & BOOKRUNNER IN CONNECTION WITH THE EQUITY RAISE AND LISTING OF COOL COMPANY
Disclosure:
The goal of the blog is to provide investment ideas for further research. I/we have a beneficial position in the shares discussed above either through stock ownership, options, or other derivatives. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article. The article does not represent investment advice. Please do your own research before making any investment action.
Big day for QFUEL today. Plenty of additional catalysts in the pipeline. Expect wave of broker price target re-ratings. Shorts should be covering. Next two lines modifications should be completed very soon. All four lines should be in operation in Q2. We have been bullish and we are very bullish now.
Terje Eiken, COO of Quantafuel just announced, that he bought 10 000 shares at 21.85 NOK today. Symbolic gesture.
I think there is plenty newsflow in the short term:
Short covering
Price target changes – Pareto, and Fearnley placed QFUEL price target under review. It means that they may publish PT uplift. Others should follow
Completion of modifications on all four lines (within two weeks)
Start of the production on all four lines (during Q2)
Q1 results – the previous Q4 was the best presentation I saw from QFUEL. We have a high expectations from Q1 call
Further announcements on production milestones
Strategic partnerships progress
Pareto
QFUEL NO – Quantafuel – Proof of Concept at Skive
Quantafuel announces Proof of Concept (PoC) for its Skive plant, being a key milestone to I) further derisk the technology and to II) move forward with larger-scale Plastic-to-Liquid plants (Quantafuel has a pipeline of more than 5 plants). The company defines PoC as >7 days of continuous production with an uptime above 90% at 16,000 tonnes of annual capacity, with an overall oil yield of 68%. Going forward, the company will continue to remove bottlenecks and optimize operational parameters reaching for higher throughput and earnings, which is a normal exercise in the process industry, according to the company. Quantafuel sates that it will revert with a guiding on Skive in due course, and we also believe new FID announcements are not far away. Today’s news is a strong positive and we expect the share to trade higher after declining ~50% YTD. TP under review.
Fearnley
Quantafuel (Under review)
Reached PoC at Skive
QFUEL announce this morning that the company has reached Proof of Concept (PoC) at the chemical recycling plant in Skive, Denmark, after seven days of continuous production on the two operating lines with an uptime above 90%. This corresponds to an annual intake capacity of 16,000 tonnes of plastic waste at plant level (all four lines). Further guiding for the Skive plant will be announced shortly. Going forward, QFUEL will focus on further optimizing operations and removing bottlenecks, moving towards full operation at Skive and next-generation larger-scale facilities. We see this achievement of reaching PoC, after several delays and required upgrades, as an important step towards successful operations at Skive and supportive of the long-term growth plan. Further, we believe this to have a positive effect on investor confidence.
Sparebank
(+) QUANTAFUEL: Announces proof of concept for Skive. The past seven days it has converted 145tonnes which corresponds to an annual production of 16,000t. The achieved proof of concept equals more than 7 days of continuous production with an uptime above 90% and an oil yield of 68%. This implies just short of 11,000 tonnes of output, which QFUEL has previously announced that it will sell for USD1000/t. Hence, Skive will be expected to have an annual turnover of close to NOK100m after this PoC.
ABG Sundal
Quantafuel declares proof-of-concept for Skive
QFUEL (B) announced this morning that it has reached the very important proof-of-concept (PoC) milestone at its Skive chemical recycling plant. This includes continuous operations at >90% utilization for more than seven days at a level corresponding to an annual capacity of 16.000 tonnes of plastic waste feedstock. The oil yield achieved is 68% vs the long-term guidance for its plants which is 80% (which remains). QFUEL states it will continue to optimize parameters and remove bottlenecks to improve throughput and earnings. The milestone means the roll-out plan can continue with even greater confidence. The company will revert with guidance on Skive, but currently our assumptions for gradual ramp-up towards all four lines in operation by Q4 appears reasonable.
Other trading ideas
I wrote about Cibus on Friday. We bought at 220 after the SPO and sold at 232. Good one day trade. It is still a great value, it was 260 last week.
I sold out from very recently Norske Skog at 50% over less than a year. I love the company. It is cheap and plent of catalysts. The major fund is out of lock up now. They always sell shortly after lock up expiry. I will buy back on the SPO. It could be this week.
We are still bullish on Coolco. We wrote about the company when the share price was around 76 NOK about month ago. It is 96 NOK today. No brainier trade. EU is telling us they will source more gas from other sources than Russia. It means LNG shipping. It is already reflected in the rates. My price target is 130NOK. I believe we could be there within a month
I am bullish on Biovica. The story takes longer than I thought, the value is there in my view. Company provided bullish updates last week. Could be one of the best performing positions this year.
We are also long other pharma names: Sedana, Bioinvent, Ascelia, Vicore, Hofseth Biocare and Eigr.
We remain strongly bullish on Linkfire. They provided very strong guidance at Q4, which the market ignored. Again, this could be one of the best performing stocks this year from my portfolio. There is my article on Linkifre on SeekingAlpha and plenty on this blog.
I am long oil through Africa oil, Africa Energy, AkerBP, and Var Energi. Var is out of blackout today. 8 brokers that were in the IPO syndicate should publish their research. Very bullish short term for Var.
I am bullish on Aker Horizons. Last week transaction showed, that these guys can deliver. AKH trades at 15% discount to NAV according to Pareto. AKH was caught by the renewable sell off last year. I believe that we are seing a reversal now.
I am long Fusion Fuel Green. Similar story like AKH. I expect this to be at least doubling candidate this year.
I am also very bullish on Huddly. The management was buying in recent weeks. So we were. Again, this stock should double in next two quarters.
Disclosure:
The goal of the blog is to provide investment ideas for further research. I/we have a beneficial position in the shares discussed above either through stock ownership, options, or other derivatives. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article. The article does not represent investment advice. Please do your own research before making any investment action.
Cibus Nordic Real Estate is very solid company with great share price performance.
The company is down 20% in last five days.
The decline was most likely caused by increasing interest rates and probably rumored capital increase. The capital increase happened yesterday after close.
The company announced acquisition of its first property in Denmark and the capital increase is providing funding.
The share is up 1% so far today. I believe the company is well positioned for re-rating. I am long Cibus.
Let´s Brainstorm on Russia/Ukraine
I am looking for ideas how to invest into disruptions caused by the Russia invasion into Ukraine. Any ideas welcome – please place below the article
Disclosure:
The goal of the blog is to provide investment ideas for further research. I/we have a beneficial position in the shares discussed above either through stock ownership, options, or other derivatives. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article. The article does not represent investment advice. Please do your own research before making any investment action.
I wrote here several times about CoolCo- a spin off of 8 LNG tankers by Golar. Today, there were two articles that support the story. It is reflected in the share price, which increased to 85 NOK. My price target is 120 NOK.
Soaring LNG Demand Creates Traffic Jam At Gulf Of Mexico Ports
The goal of the blog is to provide investment ideas for further research. I/we have a beneficial position in the shares discussed above either through stock ownership, options, or other derivatives. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article. The article does not represent investment advice. Please do your own research before making any investment action.
Pareto summary: With energy security becoming the new buzzword after the tragic Ukraine- invasion, modern LNG carriers are set to benefit. CoolCo has already secured one timecharter at a stellar rate since its recent inception – and we expect more to come. Ofer and Trøim have created a vehicle that provides plenty of leverage both operationally and financially – and having traded down since the IPO with initiate coverage with TP of 100 and ~25% upside
My take: I wrote about CoolCo about two weeks ago. I suggested CoolCo as a qtrading idea for the case situation in Ukraine escalates further and gas supplies get interrupted. This did not happen yet, CoolCo is up only a few % since I wrote about it. I belive the idea still stands. The company is progressing well, charter for usd120k per day was confirmed last week. The company should rerate. And if there is a gas interruption, it will skyrocket. Great risk reward in my view.
Pareto front page summary:
Clean play on TFDE-vessels, plenty of leverage… With 8x LNGCs built in 2013/14, Golar spin-off CoolCo has most of its fleet exposed to the spot markets in the coming years – and already secured some stellar charters. Focus will be on growth, and we expect accretive transactions to consolidate the fragmented market. The set-up is clean and transparent, with a cash break-even of ~USD 50,000/day and ambition to pay out the ‘majority of free cashflow’ to shareholders. Under our conservative USD 70,000/day market for 2023 this means a yield of ~7% – but clearly room for more.
…to a market that is becoming increasingly political The LNGC market has seen higher and higher peaks over the past years, with global gas prices continuing their wild swings. The tragic invasion of Ukraine has put European energy security in the spotlight, with the EU targeting a rapid substitution of at least 35mtpa of LNG equivalent. The LNG market is already tight – providing plenty of arbitrage out of the US Gulf – and higher European prices to soak up cargoes from as far as Australia could mean that the current LNGC orderbook goes from a small 2023/24 concern – to not sufficient. The longer-term fundamentals are in any case appealing, with shipyard inflation full orderbooks making us doubt that we will have enough ships for 2025/26 – setting the stage for a true super-cycle. We will see more US export projects sanctioned – projects that are more tonne-mile intensive than others.
BUY TP NOK 100 – bull-case in ‘22/23 adds another NOK 15 We expect COOL to be an active consolidator and grow its fleet substantially in the years to come. Trading above our conservative NAV any ‘ship-for-share’ transaction should be accretive. We find EV/EBITDA 2023e of 6x attractive, with ample upside if more fixtures are secured. Our TP of NOK 100 is derived from a YE’23 NAV, and would increase to NOK 115 if H2’22 – 2023 averages USD 100,000/day, and another NOK 25 if we raise asset values by 10%. CoolCo is the leveraged bet on the near-term LNGC market – a bet we find intriguing given the political and strategic importance of LNG infrastructure now.
Disclosure: The goal of the blog is to provide investment ideas for further research. I/we have a beneficial position in the shares discussed above either through stock ownership, options, or other derivatives. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article. The article does not represent investment advice. Please do your own research before making any investment action.
The main quotes from Biovica CEO Anders Rylander 5 minute interview with Redeye Research yesterday are below.
We got a very positive FDA feedback in February. That was very positive, because no more issues in the clinical area and only on study that we need to complement.
We will redo the study that we have done before. We are already working on it and the May deadline (for FDA response submission) we believe we should be able to meet.
We have performed the production of the samples and now we are doing the additional tests the FDA has requested.
This is not about new client test. It is about precision test we have done before – this is just in slightly different format with additional samples.
We are confident we can reproduce samples we have done in the past
We are confident we will meet the deadline
This should be the end of FDA review phase. After submission it generally takes 30-60 days for FDA to issue the clearance under normal conditions.
The goal of the blog is to provide investment ideas for further research. I/we have a beneficial position in the shares discussed above either through stock ownership, options, or other derivatives. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article. The article does not represent investment advice. Please do your own research before making any investment action.
Fearnley Securities: QFUEL announced this morning that repairment of the burner chambers of the two first lines have been completed and tested for production. Both lines have converted plastic waste at a high load after repair completion, and the plant is gradually returning to production.
The timing is in line with QFUEL’s target (announced early February) to resume production in the two lines by mid-March. Going forward, focus remains on increasing uptime and capacity in the production lines to reach Proof-of-Concept.
ABG Sundal Collier:
Quantafuel is back in production on SkiveABG Sundal Collier acted as joint bookrunner in the NOK 400m private placement in Quantafuel QFUEL (B) announced this morning that it has completed the repair work for the first two production lines in Skive. Both lines have been tested in production and have converted plastics at high load after the repair. The plant is gradually returning to production now. This is in line with the comments from the Q4 report end February where it stated that both lines were expected operational by mid-March. It is positive to see that Skive is now operational.
Note on valuation
Before the announcement on the production interruption QFUEL traded above 25 NOK. On the announcement it went down to around 15 NOK. Today the stock gained back to 20 NOK. We are still 20% below the announcement.
When the market believed that Proof of Concept is eminent, the stock was trading close to 80 NOK. Based on all the conversations we had we believe that the proof of concept is at max weeks away. There is plenty of upside.
Disclosure:
The goal of the blog is to provide investment ideas for further research. I/we have a beneficial position in the shares discussed above either through stock ownership, options, or other derivatives. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article. The article does not represent investment advice. Please do your own research before making any investment action.
Redeye: The essential Q3 (November-January) feedback is that the FDA process progresses without significant internal or external disruptions. Biovica is on track for submitting supplementary results in May, and the company is also on track to secure a likely conclusive subsequent FDA decision in July to August, in our view.
Pareto take on today´s results:
Q3 21/22 (Nov-Jan) report takes – Setting-up own lab in the US
Biovica’s Q3 21/22 (Nov-Jan) report was in line with our expectations. The cash burn rate of SEK -14m (-11m) remains increased over last year due to commercialization activities. Cash and cash equivalents at the end of the period amounted to SEK 108m (155), which should last the company into 2H 2023. Biovica will hold a teleconference today at 15:00 CET and in case anything new is mentioned we will follow-up thereafter. While the regulatory delay was long, our view on the product has not changed, we thus reiterate our Buy rating on BIOVIC with a target price of SEK 103.
Last regulatory step As mentioned in our note last month, Biovica is preparing to conduct a lab study which is to validate previous results related to DiviTum material specifications and inter-lot variability. The additional data will be included into the re-submission of the 510(k) submission scheduled for May. The FDA will then approve or reject within 30 days i.e. within June (given the FDA sticks to its timelines which we expect to be the case unless there is a resurgence of COVID-19). Considering the extensive FDA discussions that lay behind this last piece of analytical data to be submitted, we believe that DiviTum has a high chance of approval i.e. the FDA is unlikely to suddenly come up with a new concern.
Own US lab for commercial operations Biovica announced yesterday that the company is establishing its own analytical lab in the US (in San Diego), which allows more direct interactions between Biovica and payers (as the labs are the ones receiving the reimbursement). It also enables a more direct contact with physicians and patients, which are critical interactions to achieve successful sales. With a foreign lab, Biovica’s test might not get the same attention as it does with an in-house one. Furthermore, due to a missing intermediate, Biovica’s margins on DiviTum are increased.
Rede
Redeye Research Summary
The essential Q3 (November-January) feedback is that the FDA process progresses without significant internal or external disruptions. Biovica is on track for submitting supplementary results in May, and the company is also on track to secure a likely conclusive subsequent FDA decision in July to August, in our view.
In the current geopolitical state with logistical and procedural challenges, the Biovica message that the company remains on track to deliver in May is reassuring. It reduces the risk for any near-term delays in our view.
Biovica continues to secure additional scientific support from studies, including test studies, health economy studies, independent studies, and support from credible publications. This is important to ensure post-approval launch support later in 2022 and beyond.
Biovica has also recruited Kendon Richard as head of sales. We can expect Biovica to share sales and marketing material later in the spring and the updated market access and reimbursement strategy. The decision to set up an in-house CLIA Lab (CLIA = The Clinical Laboratory Improvement Amendments) in San Diego is probably part of this process. This lab will be operational during Q3, and it needs to secure FDA and CMS recognition/certification to our understanding. This Biovica lab will process the Divitum test, and it is also likely to collaborate with future clinical, distribution and commercial partners. The strategy will provide Biovica with improved control of the early launch process, including the pricing, reimbursement and future label expansion processes.
The cost base remains contained with a slight increase reflecting the upcoming US launch with SEK 14.4m during Q3, and the financial position is SEK 108m in cash as of the end of January 2022, which is sufficient for the next 12 months.
The next key trigger
Biovica is on track to deliver the supplementary data to FDA in May, and then we can expect FDA feedback and a decision within 30-60 days. The following five to six months will be most decisive for Biovica. The current share price level reflects a very challenging macro environment with geopolitical disturbances. In our view, the current share price also reflects low specific expectations for Biovica when considering the size of the futures market and the scientific support to date. As a result, Biovica represents a very attractive risk-return profile for a pre-revenue company over the next six months. 2022 has the potential to be an exciting year for the company. Our value proposition is a base case value of SEK 95 (Bull SEK 325, Bear SEK 20). A near term update would not trigger any significant change apart from slightly higher market risk, and a corresponding slightly increased discount rate (WACC).
Introduce Research (by ABG)
Q3 Interim report – Launch in US with own CLIA laboratory
SEK 000s
Q3 21/22
Q3 20/21
May-Jan 21/22
May-Jan 20/21
Full year 20/21
Net sales
314
1,376
963
1,759
2,077
Operating profit (loss)
-14,417
-11,062
-40,970
-28,012
-40,181
Profit (loss) for the period
-14,334
-10,909
-40,947
-27,491
-39,482
Earnings per share, after dilution
-0.50
-0.38
-1.44
-0.97
-1.39
Significant events during the third quarter
Article on the DiviTum®TKa Budget Impact Model published in the Journal of Medical Economics.
Three studies with DiviTum®TKa presented at SABCS 2021.
Start of TK IMPACT study at Washington University in St. Louis.
Significant events after the end of the period
Updated timetable for supplementation of the FDA submission.
DiviTum®TKa results from the PYTHIA study published in EJC.
Decision to set up own CLIA laboratory in San Diego, USA.
CEO’s comments In February, just after the end of the quarter, we received feedback from the FDA, which means that we have a plan for our continued application process. Now, with the FDA’s feedback, we know what information we need to supply in order to answer their last remaining question and we feel certain that we will be able to provide them with the information they are asking for.
We believe that the interactive process we have had with the FDA will be to our advantage during their review (once we have submitted the supplement) since we will have answered all questions that arose during the process.
Our work to provide the information requested by the FDA has progressed well. Hence, we feel confident that we can reach the previously communicated goal to provide FDA with the information during May 2022.
During the quarter, we also continued our preparations for the upcoming launch. Warren Cresswell, President of the Americas, now will be joined by Kendon Richard, who has been recruited as the new Head of Sales. Kendon has more than 25 years of experience in sales. Most recently, he held the position of Senior Director National Sales at the diagnostics company, Prometheus Laboratories, where he built up and developed the sales organization. He also has many years of experience working with sales, primarily at Procter & Gamble.
By building up the organization and processes, we will be prepared to start selling as soon as possible after we receive market approval. Under the surface, much work is being done to prepare our marketing and sales material and we hope to be able to present our new material later this spring. We are also working with the plan for market access and reimbursement.
One important decision that our Board of Directors has made is to offer DiviTum®TKa in the USA by setting up a wholly-owned laboratory in San Diego. It will serve the entire country and there are major benefits associated with this solution. It enables us to have direct contact with our customers and payers, along with better circumstances for being able to establish a price for DiviTum®TKa that reflects the significant benefits it can offer to both payers and patients. We will also improve our margins with this solution.
With our laboratory, we can also build a biobank of patient samples that we will be able to use in the development of new products. It will enable us to more quickly add new biomarkers for new applications and improved performance. It will become a valuable asset to the company.
We are expecting to receive the CLIA laboratory certification during the third quarter 2022.
One important cornerstone for a successful launch is strong scientific support. It was therefore very encouraging to see recognition that DiviTum®TKa received during the last quarter. For example, the results from three studies with DiviTum®TKa, including a budget impact model, were presented at the world’s largest breast cancer conference, San Antonio Breast Cancer Symposium (SABCS), in December. The results of the budget impact model were also published in the Journal of Medical Economics and subsequent to the end of the quarter, positive results from the PYTHIA study were published in the European Journal of Cancer (EJC).
Although publications of prior study results are important, we must continue our efforts to strengthen the clinical evidence for DiviTum®TKa even more by initiating and supporting more studies. One example is the TK IMPACT study, which began during the last quarter. It is an investigator initiated prospective trial at Washington University of St Louis to evaluate the clinical utility of DiviTum®TKa on monitoring practices in the care of metastatic breast cancer patients. The study will examine care over time of 55 patients that will be tested regularly with DiviTum®TKa. Our vision is to change the standard of care in monitoring to easy, quick and safe blood-based TKa testing that benefits patients.
We have an intensive period ahead of us to supplement the last remaining information to the FDA, obtain 510(k) clearance, set up our CLIA laboratory and then launch DiviTum®TKa in the US market. I’m looking forward to it all with great enthusiasm!
Disclosure:
The goal of the blog is to provide investment ideas for further research. I/we have a beneficial position in the shares discussed above either through stock ownership, options, or other derivatives. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article. The article does not represent investment advice. Please do your own research before making any investment action.
Fit Investment Ideas 