It has been a busy week for pharma giants reporting their latest quarterly earnings and a lot of them have exceeded analysts’ estimates.

Novartis, Merck, Bristol-Myers Squibb, Biogen, AstraZeneca, and Sanofi all reported quarterly earning this week and all but one managed to outperform Wall Street total revenue expectations. But even in the case of Biogen, where its total revenue came in slightly below projections, its groundbreaking Alzheimer’s drug Leqembi did better than expected.

Here’s a breakdown of how drug sales at these companies faired in the most recent quarter of 2024.

📈 Novartis

Novartis sales rose 10% in the last three months ending March 31 to $11.8 billion, up from $10.8 billion in the same period the prior year. Its total revenue came in above a consensus estimate of $10.4 billion, according to FactSet.

Novarits stock was slightly up on Thursday to about $99.

📈 Merck

Merck’s’s total revenue rose 9% year over year to $15.7 billion in its first quarter, exceeding analysts’ expectations of $15.2 billion. Sales were primarily driven by the company’s blockbuster cancer drug Keytruda.

Sales of Keytruda soared 20% in the first quarter of the year to $6.9 billion, compared with $5.8 billion in the same period last year. It outperformed Wall Street analysts’ expectations of $6.7 billion

Merck’s stock jumped 3% to about $130 during Thursday morning trading.

📈 AstraZeneca

U.K.-based AstraZeneca blew past analysts’ predictions. Its total revenue in the first quarter reached $10.2 billion, almost $1 billion over Wall Street estimates of $9.5 billion.

Its stock rose 6% to about $75 on Thursday following its latest quarterly earnings report.

📈 Sanofi

Sanofi also beat expectations when it reported $10.9 billion in sales for its first quarter, just above a consensus estimate of $10.7 billion, according to FactSet.

Sanofi stock is up 6% to about $49.

📉 Bristol-Myers Squibb

Bristol-Myers’s total revenue in the first quarter grew 4% year over year to $11.8 billion, from $11.3 billion. It outperformed Wall Street estimates of $11.4 billion.

Despite this, the company’s stock dropped 8% to $45 on Thursday.

📉 Biogen

Although Biogen did not meet total revenue expectations, the Cambridge, Massachusetts-based pharmaceutical company reported higher than expected sales of its groundbreaking Alzheimer’s drug Leqembi.

Leqembi generated $19 million in the first quarter of 2024, outperforming analyst expectations of $11 million, according to FactSet. That figure is more than triple the amount of sales the drug generated in the fourth quarter of 2023.

The company’s total revenue fell 7% year over year to $2.29 billion in its first quarter, from $2.5 billion. It was slightly below expectations of $2.3 billion.

Biogen’s stock fell 1% to $199 on Thursday.

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Read more: https://qz.com/pharma-sales-q1-1851435519

Forgot to post revised DD here.

• Cormedix (CRMD) is a biotech company that primarily focuses on the prevention of Catheter Related Blood infections with their leading product, Defencath. Catheter Related Blood Infections plagues the End Stage Disease Population. According to the National Institute of Diabetes and Digestive and Kidney Disease Institute, nearly 808,000 people suffer from this ailment, and approximately 69% are on dialysis(https://www.niddk.nih.gov/health-information/health-statistics/kidney-disease#:~:text=Nearly%20808%2C000%20people%20in%20the,31%25%20with%20a%20kidney%20transplant.)))

• Defencath is a catheter lock solution that eliminates both gram positive and gram negative bacterial infections that develop within the Catheter. Defencath is composed of a solution of taurolidine and heparin that effectively reduces the CRBSI events in this vulnerable population.

• However, this population has a catheter that is surgically implanted into their patient and its called a, “Central Venous Catheter.” This type of catheter is placed near a large center vein most commonly an internal jugular or subclavian. In layman terms, it’s placed near the patient's heart, implanted on the patient to administer medication or to administer hemo-dialysis.

• The results of their Lock-100 Study had 71% reduction in CRBIS compared to the control (https://pubmed.ncbi.nlm.nih.gov/37678222/). Additionally, They rejected the null hypothesis by a P value of .0006 to such a degree that it would only occur in 1 in 10,000 tries due to sheer random chance. Therefore, the phase III study was halted.

• There are approximately 250,000k CRBIS events per year according to this site,(https://www.sciencedirect.com/topics/nursing-and-health-professions/catheter-infection#:~:text=Catheter%2Drelated%20infections%20remain%20among%20the%20top%20three,catheter%2Drelated%20infections%20is%20approximately%2014%%2C%20and%2019)

• You can check the company’s most recent deck to see the potential impact of Defencath on CRBIS here, (https://cormedix.com/wp-content/uploads/2023/03/CorMedix-Corp-Presentation_1-7-23.pdf)

• As of November 15, 2023 Cormedix received a NDA Approval by the FDA for the limited population of Adult patients affected by kidney failure( https://cormedix.com/cormedix-inc-announces-fda-approval-of-defencath-to-reduce-the-incidence-of-catheter-related-bloodstream-infections-in-adult-hemodialysis-patients/#:~:text=About%20CorMedix&text=DefenCath%20has%20been%20designated%20by,address%20an%20unmet%20medical%20need.)))

• As of January 30, and April 9th 2024, Cormedix secured CMS J-Codes for In-Patient and Outpatient settings.( https://cormedix.com/cormedix-inc-announces-commercial-and-reimbursement-updates/) and (https://cormedix.com/cormedix-inc-announces-commercial-agreement-with-arc-dialysis-llc/)

• On April 19, 2024, Cormedix Also Secured TDAPA reimbursement from CMS for the Out-Patient Setting(https://cormedix.com/cormedix-inc-announces-cms-grants-tdapa-to-defencath/).

• Lastly: on April 15, 2024, Cormedix Celebrated their commercial launch for the in-patient setting, and expect to lauch out-patient by July 1st 2024. ( https://www.globenewswire.com/news-release/2024/04/15/2862768/0/en/CorMedix-Inc-Announces-U-S-Inpatient-Commercial-Availability-of-DefenCath-Taurolidine-and-Heparin.html)

• Why is Cormedix a Deep Value Opportunity to add to your portfolio today? As of Close on 4/23/24 the stock was trading at $5.45 CEO, Joe Todisco Currently owns 352,000 shares, and added to his position by approximately 13,561 on March 13, 2024 at $3.74 per share. Additionally, other insiders have not sold any shares over the past few years. I heavily weigh insider ownership whether they were paid for, awarded, or granted in lieu of payment. You can see all insider activity here, (https://www.nasdaq.com/market-activity/stocks/crmd/insider-activity).

• The institutional ownership acquired about 33.94% of total shares on the open market with Black Rock Inc leading with 3,507,695 Shares held as of 12/31/23. Numora Holding Inc, comes in second at 2,946, 552 shares, then Vanguard at 2,825,335 million shares, and lastly Elliot Investment Management L.P., comes in at 1,550, 523 million shares. See all institutional ownership here, (https://www.nasdaq.com/market-activity/stocks/crmd/institutional-holdings)

• You’re probably wondering at this point, how does Defencath work, and what are the Projected vials to be sold? Cormedix projects to sell 3.4 million vials on the inpatient side and over 37 million vials on the out-patient side. The growth potential is HUGE!

• With such volume you’re probably wondering at this point how precisely does the product work… Well, Every Time a patient receives hemo-dialysis the catheter must be flushed with the Defencath solution before and after. That is approximately two vials per patient per visit with the average patient getting about 3 treatments per-week, out of 550,000 patients on hemodialysis.

• Cormedix plans, and is on track to launch Defencath for out-patient setting on July 1, 2024.

• Cormedix Plans on expanding its usage and application of Defencath to other populations that already have CVCs, like Oncology.

• The current short interest as of 3/31/24 is 34 million dollars or approx. 8.2 million shares.

• Marketing Plan: There are 5 major companies that control the out-patient setting, and two of them control 70% of the market. Remember, Out-patient is projected to sell appx. 37 million vials!

• The Projected market impact of the stock is incredible, and understanding the product shows the extreme value it holds.

• Debt: the company has NO debt.

• Market Exclusivity: CRMD has 10.5 years market exclusivity because it's a qualified infectious diseases, and it's a new chemical entity. And it’s intellectual property is extended until April 15, 2024. See (https://cormedix.com/cormedix-inc-announces-issuance-of-u-s-patent-covering-lead-product-defencath/)

• WHY WILL CRMD EXPLODE SOONER THAN ANALYISTS EXPECTATIONS?

• The out-patient setting is dominated by 5 major out-patient facilities, and once it received it's NDA every medical Journal posted the NDA approval AND JOE, MENTIONED THEY WERE ALREADY TALKING TO BOTH IN-PATIENT AND OUT PATIENT FACILITIES AT March 12th Earnings Call "March 12, 2024 "Joe Todisco, CorMedix CEO, commented, “I am excited about the Company’s recent progress as we have scaled up activity ahead of our commercial launch in April. We have received significant inbound interest from both inpatient facilities as well as outpatient dialysis providers with respect to DefenCath, and we are actively engaged in customer discussions in both settings of care" (https://cormedix.com/cormedix-inc-reports-fourth-quarter-and-full-year-2023-financial-results-and-provides-business-update/#:~:text=Conference%20Call%20Scheduled%20for%20Today,%C2%AE%20(taurolidine%20and%20heparin))

• Competition: There is no Drug on the market that prevents CRBIs the way Cormedix does and there is absolutely no competition.

• The CTXR guys will say we’re competition but we’re not. Mino-lock salvages an already infected Catheter. It’s a reactive medicine opposed to Defencath which is Preventative.

  • The preventative application allows for such high sales values in such an exclusive market.

• CREDIT TO Fretwizard125, “Good post and summary of what’s in play here. I’ve been in CRMD since 2018 and Have been accumulating. Have a multi-hundred thousand dollar position and am waiting for this to explode. With TDAPA we could see 70-80% market penetration really quickly, (1-2 years).

  • The Wholesale Acquisition Price FROM CRMD and approved by CMS is $250/vial. They will likely offer discounts to the providers to adopt and recognize revenue too. But even with a 70% discount for a vial potential revenue is insane.
  • Quick math $75/vial x20,000,000 vials (50% penetration) =$1.5b. Yes billion, with a B.
  • This does not include other indications they are trying to expand into including oncology and TPN. Oncology market is 1.5x the size of hemodialysis. This is a long term hold with literally the most perfect commercialization setup I’ve ever seen.”--- Credit to Fretwizard 125

• Projected Price: Low $9.00 per share, medium is $12.00 per share; high of $19.00 per share within the next year. I believe we’re going to hit the 9s in july and potentially hit 20s before December.

• TLDR: Cormedix(CRMD) Is Deep Value. It hit’s all of the marks. CRMD is poised for huge growth over the next year, reaching over a billion sales. The market is unique, and they’re going to be the standard of care. The stock is primed to explode at any day. I believe the stock will be at least 25$ per share by March 2025 if not $35-$40 per share. 5 Major companies control 100% of the out-patient market. They’ll be announcing contracts in the coming weeks. I think we can hit 12$ before the out-patient launch in July, that’s my opinion.

• All RISK IS ELIMINATED!

• POSITION:

  • 50 call contracts $6 strike, .10 cents per share, 10$ per K Exp. June 21
  • 50 call Contracts $7 strike, .10 cents per share, 10$ per K exp June 21
  • 3750 Shares average $4.15. (have a little bit of higher average because of options trading throughout the past 3 years.)

Note my responses may be delayed b/c I'm studying for finals.

I'll answer any questions, if you want to see previous discussions about the stocks you can check the most revised one in r/valueinvesting

NOTE: on competition: From a previous question on valueinvesting:

" What about things like Mino-Lok that demonstrated 100% efficacy rate and are waiting for approval at this point?"

Answer: " I’d also like to point out, that I’m surprised people haven’t found Clearguard HD patches and caps. I had forgotten about those two products because they’re not a threat. So in the name of transparency, I will elaborate!

Centeral Venus Catheters are surgically implanted, right, so between the insertion point of the flesh and catheter Cleargard has a patch I believe. That’s one way a person can get CRBIs.

They also have a CAP to seal the catheter to prevent things from getting in.

However, the catheter still must be sanitized between each hemodialysis before and after.

So that’s where Defencath replaces Heparin because it’s 21% more effective; and defencath targets both gram positive and negative bacteria as well as fungi’s.

It’s important to realize that many of these companies develop product specific solutions, and that regardless of caps, and patches biofilm will still develop within the catheter which is why defencath is necessary.

Lastly, again, Mino-lock is only used after a Catheter is already infected. So if Defencath fails then mino-lock is used.

Understanding the distinctions in these products ensures understanding the deep value cormedix holds with their Defencath CLS (Catheter Lock Solution)..."

Does the FDA approving Carvykti from J&J benefit or put pressure on the other companies that are targeting autoimmune patients with CAR-T. I know CABA and others have been on a straight sell off recently.

Looking back I see an initial pop from CABA after the April 5th approval followed by heavy selling. How much of the recent move is biotech weakness and market fear versus worries over the potential dominance from J&J as the first mover. Thoughts?

Biotech Street: When Past is Prologue

https://biotechstreet.substack.com

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Anyone think this will bounce back above $30 like their predicting?

Besides Theranos, Arrayit Corp., Decision Diagnostic who were caught for faking data and stealing millions from investors for their so-called innovative breakthroughs in science. How many are still out there?

I work for longevity company in San Francisco and I see its executives making false claims.

https://biotechstreet.substack.com

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This is my DD of Cereno Scientific.

Disclosure: I own the stock and this is not financial advice but a best effort to provide information and share some own current views as a start for individuals capable of doing their own due diligence. As well as hopefully discuss the case.

TLDR:
This is the story of an under the radar Swedish biotech company led by ex big pharma heavy-hitters, partnered with big pharma as well as officially supported by top global key opinion leaders (KOL) within cardiovascular disease (CVD) that has patented an already is a safe, tolerable and established therapeutic since it has been shown to be efficacious against thrombosis, the #1 killer in the world.
Furthermore, the company ALSO looks set to outperform established pulmonary arterial hypertension (PAH) drugs, even the new Sotatercept/Winrevair, which has an estimated $2-9B peak annual sales. Wait until you see the results, including already reported interim data on the majority of the patients in the soon to be completed phase II study.

The serendipitous mistake
The founder of Cereno Scientific is Sverker Jern, a renowned Swedish cardiologist with books published about ECG, etc.
Long story short, while trying to find out a way to restore the human bodies inherent blood clot preventing system, a "failed" experiment of a postdoc belonging to Jern´s lab led to the discovery that valproic acid (VPA) significantly inhibits HDAC. In turn, this significantly reduces PAI-1 while simultaneously increasing endogenous levels of tPA; both central to combating thrombosis.
VPA has been around and used for treating epilepsy, bipolar disease, migraine etc. since the 1960's. While high enough dosages (typically much higher than used here) can come with adverse effects, VPA is established as a safe and tolerable therapeutic still prescribed today.
Having developed a unique administration regime for VPA trough delayed-release to reduce PAI-1, which is elevated in the morning, Cereno created it´s first medical candidate, CS1. Since then, it has been shown to be safe and tolerable, reduces the levels of circulating PAI-1 as well as restore the levels of t-Pa in a phase I human trial, without increasing the risk of bleeding. Now, for those not familiar with the hematologic landscape, this is huge. The reason being that ALL existing therapeutics for thrombosis are double-edged swords that do increase this risk, causing considerable consequences for quality of life, not to mention fatal incidents. Coupled with thrombosis as the #1 underlying cause of death globally, it is not for nothing that a potential solution to this has been called the holy grail of medicine.

Global KOL's join
Having made the discovery, patented it and demonstrated results in human, the company soon garnered the attention of a number of KOL´s. A scientific advisory board (SAB) was established comprised of leading global experts within CVD. Names such as Deepak Bhatt, Raymond Benza, Bertram Pitt, Faiez Zannad, Gordon Williams and Gunnar Olsson. Do look them all up.
On the march towards a subsequent phase II trial for CS1, the course was initially set to directly target the medical indication thrombosis. However, following advice from the SAB, a strategical move to proving an even broader efficacy, shorten the time to market, thus preserving capital and prolonging IP rights, was chosen instead - for now - PAH.

The genius rationale behind proving broader efficacy quicker through PAH
Although PAH is classified as a rare disease, the market is extensive and growing rapidly. The pathophysiology is simplified as this: Due to various etiologic backgrounds, a few being genetic, related to vascular fibrosis, inflammation, etc. the pulmonary arteries undergo constant proliferation. As they progressively become narrower, stiffer and less flexible, the pulmonary pressure is raised causing the right-hand side of the heart to also proliferate in order to pump enough oxygenated blood until there is simply no more room at which point the heart fails and the patient dies.
Up until a few weeks ago (we will return to this), only simple vasodilators such as PDE5i´s which only temporarily alleviate symptoms, have been prescribed.
Now, on top of the anti-thrombotic properties, it has also been established that CS1 has anti-fibrotic, anti-inflammatory, pulmonary pressure-relieving properties as well as reverse-remodeling of underlying pathological vascular changes. As the CEO of Cereno Sten Sörensen states - "CS1 fits like a hand in a glove for PAH". As a parenthesis, Sörensen successfully led the RALES study at Monsanto as well as MERIT-HF at AstraZeneca. Both aimed at expanding the use for already existing compounds, just like with CS1.
As an incentive to formulate treatments for rare diseases, the FDA/EMA can grant Orphan Drug Designation (ODD). The benefits, if approved, are multifold but what is of most importance here are simplified regulatory pathways to get to market. For instance, 7 years market exclusivity is also granted but the company already has extensive patents in place.
Cereno was granted ODD by the FDA in 2020.
If this is deemed as a tactical sound move, the next part ought to be considered a strategical masterclass. First a bit of necessary background to make it understandable:
Phase I is to evaluate safety and tolerability. Phase II trials expand on this with a larger patient sample size, as well as incorporate one or a few efficacy markers.
The phase II study of Cereno is setup to measure approximately 30 of them. Why?
For the sake of keeping this short, CS1 ("optimized" VPA) is an HDACi and it's mode of action is through epigenetic modulation. VPA has already in numerous studies throughout the years been found to positively impact risk markers for several CVD's and research revolving around HDACi's in general has picked up tremendous speed also in areas such as cancer treatment. It is effectively a form of gene therapy.
While Cereno has specifically patented VPA, the company has additionally managed to patent ALL forms of HDACi, not only for thrombosis but also for improving endogenous fibrinolysis which could possibly be relevant for all forms of CVD but certainly for several broad indications such as heart failure, myocardial infarction and atherosclerosis.
Hence, this phase II study is officially targeting PAH through markers such as mean pulmonary arterial pressure (mPAP) and 6 minute walking distance (6MWD) since everything points to that this should be a fast-forwarded slam dunk - but also incorporates markers relevant for other major indications - including PAI-1 for thrombosis.
So, what started off as a mission to prove efficacy for "only" thrombosis has turned into a phase II study that will shine light on an avenue a lot broader, all at once.

In order to demonstrate this, the study participants are evenly distributed across three groups and administered one of three doses:

1. A low dose, the same dose that reduced PAI-1 and showed anti-thrombotic properties, to confirm what was shown in Ph1.
2. The dose shown in animal models to be clinically relevant for PAH by alleviating hypertension and show reverse remodeling capacity.
3. Double the second dose to see whether an even higher dose means more effect and also to possibly show a dose response pattern.

I.e. a "perfect score" would be to demonstrate effects in 33% to 66% of the total number of patients depending on if dose #2 or #3 is enough in human.
Regarding safety and tolerability, even the highest dose is lower than what is typically used for treating epilepsy. Furthermore, since PAH is a deadly disease with a very poor prognosis that lacks the possibility of significant spontaneous remission (patients do not get better without intervention, instead tend to progressively get worse), placebo is only formally to be included in the subsequent phase III trial and deemed unnecessary by the FDA in the ongoing Ph2 trial due to the known safety profile of VPA.

Big pharma Abbott partners with Cereno
While planning for the phase II trial, Cereno and Abbott announced a mutual partnership for the same to which Abbott is to supply their CardioMEMS HF implanted sensor to Cereno's patients. The implications being multifold but mainly that instead of being bound to a few select measurements through right heart catheterization (RHC), the study now monitors many of the markers in real time. Measuring mPAP with CardioMEMS is highly superior to RHC due to the numerous measurements taken daily in comparison to RHC that is otherwise done only 3-4 times during a full trial. Due to the individual variability in the patients, RHC would demand 4 times as many patients to be able to detect the same difference in mPAP as with CardioMEMS. Further solidifying CardioMEMS as an improved health monitor by choosing Cereno and their extensive study protocol as a partner benefits Abbott.

The patents stand their ground - and Cereno scoops up two additional candidates
In 2018, University of Michigan (UoM) filed for a patent for the usage of VPA to treat and/or prevent heart disease. This claim was rejected due to one (WO201605579) of the multiple patent families in place by Cereno.
What then took place is beautiful:

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1. UoM licenses their own medical candidate ML585, renamed to CS585 to Cereno. A prostacyclin (IP) receptor agonist.

2. Cereno is contacted by Emeriti Bio, (comprised of a group of legends behind multiple blockbusters such as Losec), and acquires CS014, a next generation VPA analogue. Data points to an even better safety profile than CS1, giving Cereno a potential next, next (2x) generation compound.

3. Michael Holinstat at UoM, and the inventor of CS585, has later been engaged as the Director of translational research at Cereno to evaluate these assets through the preclinical stages of development. And both have shown to prevent thrombosis without the risk of bleeding in all research so far. In other words, Cereno is now in possession of what seems to be the only compounds in the world capable of addressing thrombosis without increasing the risk of bleeding. Seemingly three times the holy grail. Data confirming this has since been shown at the worlds most prestigious CVD conferences (ESC, ASH, ACC, BIO-EUROPE, PVRI, NAHC, CVCT, NLSDays, ISTH, EHA, etc.). Patents are already granted for all candidates.

“Remarkable!” results
Since Cereno has already demonstrated efficacy for thrombosis (PAI-1), this metric should be a given success yet again and are measured once the study nears completion. But let's dive into the ones related to PAH since these are continually measured by the CardioMEMS device:
During summer of -23, Cereno was contacted by one of the clinics involved, inquiring Cereno to pursue an abstract at the upcoming American Heart Association congress that was being held November -23. The first patient to complete the trial was done and had what seemed like an astounding improvement in symptoms. Cereno instead opted to communicate the results seen so far to the market. The results from the first patient?
30% reduction in mPAP.
20% improvement in Cardiac Output (CO).
Improvement in WHO Functional Class (FC) from II to I, meaning from having debilitating symptoms to basically being able to live a normal life. Judging from the most prominent PAH trials, patients starting from FC III usually yield greater results than the ones starting from II. Meaning that data points to potentially even more efficacy to be tapped than for this patient.
Or, as  Raymond Benza, knighted director of pulmonary hypertension at Mt. Sinai Hospital in New York and principle investigator of the study and member of Cereno's SAB stated:
"We were hoping for a 10% reduction (in mPAP) - here we saw a 30% reduction - That is really remarkable!"

Competitor analysis
To keep this short, the only relevant reference to compare CS1 to is Sotatercept (now Winrevair). Approved by the FDA March 26th, it does come with risks of treatment adverse events such as increased risk of bleeding, hypertension, erythrocytosis, etc. but is still a significant step forward for patients suffering from PAH.
Central to evaluating efficacy in PAH is PVR and 6MWD. PVR is calculated (PVR=80(mPAP-mPAWP/CO)) once the study is completed. So far there is both mPAP and CO from the first patient.
6MWD is also communicated at study completion.
But already in the first patient, Cereno demonstrated better efficacy in PAH for relevant markers than ever previously seen.
The important marker CO was not improved at all by Sotatercept.
The onset (time from first dose to effects) of CS1 is also quicker.
And the administration comes in the form of a pill instead of injectables, which is easier for patients.
Furthermore, on March 27th, CNN writes this about Sotatercept:
“In animal studies conducted before the human trials, the drug looked like it could do more than just treat symptoms: It seemed like it might be able to stop the thickening of the blood vessels and perhaps prolong patients’ lives, but those benefits have not been proven in humans.”
Now back to what Dr. Raymond Benza has to say about CS1 on the subject:
"Our effect on resistance was much more than what would be expected just with the effect in cardiac output. That means that this vessel is actually remodeling, and the resistance is coming down through a change in architecture of the vessel. That is really exciting to me".

Also, CS1 did all this in half the time compared to Sotatercept (12 vs 24 weeks).

A fluke? Interim findings are in and the answer is unequivocally no
The apparent question surfaced - Exceptional results, but was this a one-time fluke?
During fall of -23, Cereno announced interim findings (as a part of a DQCR) for 16 of the to be 30 patients including the following (in ""):

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1. "More than 60% of patients on CS1, all doses included, have a sustained reduction in mPAP." In other words, somewhere around 100% of the patients aimed for in a best case scenario.

2. "An efficacy response compatible with a dose-response pattern." Being an open study, it would be logical to deduce that there seems to be three distinct differences in dose-response, as per the dosage protocol.

3. *"Several patients with a reduction in mPAP of similar or greater magnitude as the initial Patient Case".*This speaks for itself.

4. "The DQCR indicates an early onset of action". Patient #1 saw onset at 6 weeks but here is stated that "this early onset was observed already after 3 weeks for several patients". In comparison, onset for existing PAH medications apart from simple vasodilators is typically 12-15 weeks.

5. "The DQCR showed a sustained reduction of mPAP in the 2-week follow-up period after the 12-week period of therapy with CS1 was discontinued." Indicating that a remodeling effect on the vessels has indeed taken place trough epigenetic modulation.

Again, the literature is clear; Patients with PAH just tend to get worse and simply do not see these results without intervention.

Cereno is granted "Compassionate use" by the FDA
Having continued to demonstrate remarkable results also in the interim analysis, Cereno communicated to the market that they were now receiving even more inquiries from the clinics involved in the current study. This time stemming from a wish from both patients and treating clinicians to be able to continue with CS1 after the study ends.
Expanded access/compassionate use, can be granted when faced with a severe condition where no good alternative medications exist, and if the FDA deems the demonstrated benefits as good enough. Cereno applied late -23.
The FDA approved in January -24 and by this time Cereno also communicated that they now had been informed that the majority of the patients in the study would like to be able to continue with CS1.
Apart from already being obvious exceptional news, this enables Cereno to generate a dataset for CS1 orders of magnitude more vast, since it will be possible to study even longer term results already now during phase II. As some may know, the dataset is everything when it comes to value.

Risks & critique
What if the phase II study fails?
CS1 and its pioneering approach has already been documented to show significant decrease in PAI-1 in human and has shown proof of concept in preclinical models in PAH by reducing the pressure in the vessels and achieving reverse remodeling. The company has also already communicated findings related to PAH for the majority of the patients in the current study which further support the findings seen in the preclinic. Look at them. Now do your own due diligence.

Why so cheap?
The answer is probably twofold. First, although Cereno has operations in the US and the current study only uses US clinics, it is a Swedish biotech company still flying under the radar.
There is a Swedish discord for the stock with some knowledgeable MD´s, scientists, etc. trying to explain what is going on but the majority of retail investors don’t seem to understand.
Which brings us to second; institutional and professional investors typically enter post phase II results. According to Cereno, there is also already great interest from potential partners/buyers but the same goes here - phase II results first.
The BoD and Management of Cereno have greatly increased their ownership exposure ever since presenting the results for patient #1 last year

Delay?
Following Covid 19, there were administrative difficulties in starting up the nine clinics for the phase II trial resulting in the study being postponed and initial patient recruitment was also slow. To mitigate this, Cereno announced two additional clinics. The last of which should now be starting up at any time, since the company recently disclosed which one it is - Mt. Sinai Hospital, New York.
Topline results are to be presented in Q3. The study is 12 weeks and had 26/30 patients enrolled by the last update in February. Hence, study completion could be delayed but given that only a maximum of 4 patients remain to be enrolled before end of June, it seems unlikely today. Since capital runway exists until spring -25, this should pose no vital threat regardless.

"Too much communication"?
This is the only possibly negative feedback I've seen that has not yet been disproven. While I do think that many press releases in a short amount of time can sometimes pose more questions than they answer, in my opinion, this is not the case here. Having read them all, and while I do understand that not everyone is interested in which new country a patent has been accepted in or what events the the company will be attending, the rest is vital information. Cereno also sends copies of all press releases in English as well as Swedish, doubling the amount.

Wrapping up
This only scratches the surface.
If you are of a curious nature, maybe you will find interest in possible pieces to this puzzle such as that big pharma Bristol Myers Squibb (BMS) was engaged in buyout talks with Acceleron (Sotatercept) that was instead acquired by Merck. That Deepak Bhatt sits on the board of BMS - And now also in the SAB of Cereno.

But if nothing else, I think the following speaks for itself:
The total addressable market (TAM) for PAH is projected to reach $12B by 2030.

The closest thing to a competitor (Sotatercept/Winrevair) was sold for approximately $7B after phase II. $8B today, adjusted for inflation. At the time of the acquisition, peak future sales was thought to come in at $2B. Since then, revised projections upwards of $9B have been made.
The current market cap of Cereno Scientific is around $100M.
Without speculating what a fair value should really be, that´s already a difference of around 80x. And compared to a lower peak sales than more recent projections. Plus, this is only from PAH, not counting thrombosis, with a TAM of 6x that of PAH.
Cereno has already proven that CS1 can achieve results in PAH seen by no other therapeutic. And has already disclosed findings for the majority of the patients.
The Phase II trial now only has a few patients left to recruit before completion.Cereno holds two additional candidates aimed at targeting thrombosis without bleeding, both seemingly unique and holding up so far.
The TAM for thrombosis is projected to reach $70B by 2030.
If Cereno replicates results for CS1 and PAI-1 a fourth(!) time, it would mean that their current PAH study also validates CS014 for thrombosis to quite some extent. Remember, they are both VPA.
Bottom line – There are multiple shots at multiple staggering markets from one single study about to be completed – and the results so far are stellar.

Biotech stocks were among the worst performers in 2023. And so far in 2024, investors are still waiting on the recovery rally. Many small-cap biotech stocks are being held back by the Fed’s more restrictive stance on interest rates. But even some of the large-cap names with commercially available drugs that are household names are also underperforming the market.

But “some” isn’t the same as “all.” In a stock picker’s market, you want to find the stocks that have a chance to outperform. One way to find these stocks is to look at analyst ratings. The three stocks in this article all have multiple Strong Buy ratings from analysts in addition to bullish price targets. Two of the stocks mentioned are Dividend Kings, which give you the added benefit of compounding as you hold the stock.

Analyst ratings aren’t always an exact correlation, but they are a helpful way to narrow your focus and hone your research. That’s particularly important when it comes to the notoriously volatile biotech sector.

• AbbVie (ABBV): The company looks to have navigating its Humira headwind and is set up for strong growth. 
• Johnson & Johnson (JNJ): The acquisition of Shockwave Medical (SWAV) opens a new revenue stream for the company. 
• CRISPR Therapeutics (CRSP): The approval of Casgovy is likely to be just the beginning for this gene-editing pioneer.

Read more: https://investorplace.com/2024/04/wall-street-favorites-3-biotech-stocks-with-strong-buy-ratings-for-april-2024/

SHL Telemedicine Ltd. reports a 3.1% revenue increase in the full year of 2023, reaching $57.1 million, despite a net loss of $6.9 million due to strategic investments and restructuring costs. The company highlights market strength with significant advancements in the US and German markets, including new virtual services and direct-to-consumer sales. Looking ahead, SHL expects continued revenue growth and profitability, particularly in its Israel operations and from its investment in the US and German markets.

https://www.tipranks.com/news/company-announcements/shl-telemedicine-reports-revenue-growth-amid-expansion

US Rep. Earl Blumenauer, founding co-chair of the Congressional Cannabis Caucus, said he believes Saturday was the ‘last 4/20 celebration that cannabis will be on Schedule I’.

The long-time cannabis advocate and Oregon Democratic congressman announced recently that he would not be standing for office in the November election but told the press during an address on Friday that he will continue to pish for federal cannabis reform.

As numerous frontline politicians used the 4/20 celebration to express their support for cannabis reform, Blumenauer said that he would use ‘every opportunity’ to make the point that ‘cannabis can help the Democrats win in 2024’.

Cannabis reform can help ‘atone for being on the wrong side of the failed War on Drugs’ he suggested, arguing that in every state where cannabis has been on the ballot, it passes with a convincing majority.

It comes as the rumour mill surrounding cannabis rescheduling is once again reaching fever pitch following last week’s revelations from the White House that the ‘decision is now with the Department of Justice’.

In response to questions around whether he was familiar with rumours that the DOJ had already made up its mind, Blumenauer said: “There is the assumption that this is going to move forward, it’s going to be positive, and it’s going to be embraced.”

He went on to suggest that rescheduling could also help pave the way for the landmark SAFER Banking bill to be passed, adding that he was confident of it receiving bipartisan support.

https://businessofcannabis.com/this-is-the-last-4-20-that-cannabis-will-be-schedule-i-drug-says-blumenauer-as-he-pushes-its-election-importance/

I'm watching intercure as we near the potential rescheduling. Not financial advice.

Stoke Therapeutics (STOK): A look at basic science

https://biotechstreet.substack.com

​

https://preview.redd.it/3m0z74awm7wc1.png?width=800&format=png&auto=webp&s=1950015dd672d7eb581f4951a6795503a701370b

What is X4 Pharmaceuticals:

X4 Pharmaceuticals (XFOR) is a late-stage biopharmaceutical company specializing in rare diseases. The company currently has three drugs in its pipeline: Mavorixafor, X4P-002, and X4P-003, at various clinical phases. Their lead candidate, Mavorixafor, a potential treatment for WHIM syndrome, is currently awaiting FDA PDUFA approval on April 30, 2024.

https://preview.redd.it/h9ma1xla6vvc1.png?width=1763&format=png&auto=webp&s=71a46c02334c372fe403d83e787baaefe80417a8

WHIM (Warts, Hypogammaglobulinemia, Infections, and Myelokathexis Syndrome):

WHIM syndrome is a rare genetic disorder categorized as a primary immunodeficiency disorder (PID), which impairs the proper functioning of the body's immune system. While reports vary, estimates of the number of patients with WHIM syndrome vary from 1,000-3,700 people. Individuals with WHIM syndrome exhibit low levels of white blood cells (WBCs), B-cells, and neutrophils, which can pose significant health risks and potentially be fatal to the patient.

WHIM syndrome is caused by a gain-of-function mutation (GOF) in the CXCR4 and CXCL2 gene, which creates chemokine receptors. This mutation leads to CXCR4/L12 blocking mature neutrophils from entering the bloodstream, thus weakening the immune system.

https://preview.redd.it/mv7jya6c6vvc1.png?width=822&format=png&auto=webp&s=a98e8f2adb40c74e9dd90ba4a0c88a005badefc2

There are only two treatments available for WHIM syndrome (no official treatment has been made), both equally invasive and costly. Immunoglobulin Replacement Therapy (IRT) is the most effective treatment for combating WHIM syndrome and works by transfusing healthy antibodies to the patient via IVIG or SCIG. The second treatment for WHIM syndrome is Hematopoietic Stem Cell Transplantation (HSCT), which is similar to IRT but involves the transfusion of healthy blood stem cells instead of antibodies.

What is Mavorixafor:

Mavorixafor is the first official medication for WHIM syndrome. It is an orally administered CXCR4 antagonist taken daily and is designed to help the movement of various proteins to maintain a healthy immune system. The drug works by binding to the receptors of CXCR4, which inhibits its ability to send signals and produce proteins. This binding allows for crucial immune cells to move out of the bone marrow and into the bloodstream.Mavorixafor Study Design (Phase 3 Only):

Screening: All patients had both severe chronic neutropenia and lymphopenia

Primary and Secondary Endpoint: TAT for ANC (Absolute Neutrophil Count) and ALC (Absolute Lymphocyte Count) measured at 13, 26, 39, and 52 weeks.

Infection Related Assessments: Data reviewed by 3rd party for rate, duration, and severity of infections.

Safety Assessments: Reviewed by an independent board.

Goal: Viable treatment of people aged 12 and above diagnosed with WHIM syndrome.

https://preview.redd.it/st58g9vd6vvc1.png?width=1374&format=png&auto=webp&s=9ec73b46519b04d0b7ea951184c08dafe20f7d73

*unknown why only the female sex was separated in this study

Clinical Trial Results Mavorixafor (Phase 3 Only):

In the Phase 3 clinical trial, Mavorixafor showed significant efficacy compared to the placebo, exhibiting significant improvements across multiple areas such as TATanc, TATalc, infections, and safety, with nearly a 100% outperformance in each sector. Going deeper into the trial data reveals more about Mavorixafor's mechanism of action and its potential impact on patients with WHIM syndrome.

WBC, ALC, and ANC Count and Durability (Phase 3 Only) :

One of the most important sets of data is the amount of WBCs, ANC, and ALC present in the bloodstream, as well as the durability of the drug. The average WBC count for an adult is 4,500 to 11,000 WBCs per microliter of blood, while the average WHIM patient only has 3,920 WBCs. In the study, the average patient only had 500 lymphocyte cells (a type of WBC) per microliter of blood, which is dramatically lower than the average WHIM syndrome patients. Mavorixafor, in the WBC trial, showed a 3X improvement compared to the placebo (6X from the mean WBC measurement), with a 95% confidence interval (CI).

https://preview.redd.it/2vikja9g6vvc1.png?width=894&format=png&auto=webp&s=7712d1f05f761e35a1e7e4e7092f899a74caa192

Mavorixafor, also showed a dramatic increase of WBC (ALC) durability by almost 400% compared to the placebo. Mavorixafor had an average durability of 16 hours during the 52 week trial, with the placebo only lasting an average of 4 hours (95% CI).

https://preview.redd.it/9afybxvh6vvc1.png?width=1327&format=png&auto=webp&s=c46453197a6d5aa2a438211f95fbcca63b99c878

An adult male has an ANC (Average Neutrophil Count) range of 2,500-6,000 per microliter of blood. The average WHIM syndrome patient has an ANC of 500, and in this trial, the average ANC was 173. A neutrophil is a type of WBC specifically designed to fight off common bacterial infections. Having an ANC of >500 could increase your risk of infection much higher. Over the 52-week period, Mavorixafor increased the ANC to a mean of 900, while the placebo only had an ANC of 300 (95% CI). Mavorixafor not only beat the placebo by 300%, but it also increased ANC levels over 500, dramatically reducing a patient's risk of infection.

https://preview.redd.it/80qdqabj6vvc1.png?width=851&format=png&auto=webp&s=3442453947dcc359f59c861a9fdf1e1e525b5d5c

Mavorixafor also showed much better ANC durability over the course of 52 weeks, with an average of 14 hours, compared to the placebo’s 4 hours

https://preview.redd.it/lawie1fl6vvc1.png?width=1259&format=png&auto=webp&s=780b5c0b6b6800b2f9fa310f86cd18abb977ce10

Infections: Severity, Frequency, Duration (Phase 3 Only):

While Mavorixafor has proven to have significantly better efficacy and durability than the placebo, the real effects of this drug are shown in the infections and safety part of the trial. Individuals with WHIM syndrome are very susceptible to serious complications from basic diseases like the flu and strep. Mavorixafor has shown large reductions in the severity, frequency, and duration of these infections compared to the placebo.

Severity (Phase 3 Only) (%(N)):

In the phase 3 clinical trial, Mavorixafor consistently outperformed the placebo, showing significant reductions in the severity of infections and the need for antibacterials. To measure the severity of these infections, XFOR used the Standard CTCAE Criteria:

Grade 1: Does not require treatment

Grade 2: Often symptomatic treatment but are not life-threatening

Grade 3: Potentially life-threatening if left untreated

Grade 4: Actually life-threatening

Grade 5: Death

During the trial Mavorixafor only had 71%(10) of patients have Grade 1 or 2 infections, 4%(1) have a Grade 3 infection, and 25%(3) did not report any infections during the 52 week period. On the other hand the placebo had 65%(11) of patients have Grade 1 or 2 infections, 24%(4) have Grade 3 infections, 6%(1) have a Grade 4 infection, and 6%(1) did not report any infection. This shows that Mavorixafor is very effective at reducing the severity of infections with many suffering symptoms of a healthy adult. The placebo on the other hand, was ineffective at reducing the severity of infections with 30% of participants suffering from Grade 3+ infections.

*percentages have been rounded to the nearest tenth or hundredth and may or may not add up to 100%

Mavorixafor also reduced the need for antibiotics, antibacterials, and other medication interventions when compared to the placebo. Only 3(21%) of patients that were on Mavorixafor needed medications, while the placebo had 10(59%) of patients needing medication.

*percentages have been rounded to the nearest tenth or hundredth and may or may not add up to 100%

Infections: Frequency (Phase 3 Only):

Mavorixafor was compared against the placebo for a variety of infection frequencies, including Annualized Infection Rate (AIR), Annualized Infection Rate for 0-6 months and 6-12 months, subgroups, and Organ Systems. Mavorixafor significantly outperformed the placebo by large percentages in all categories and showed better performance over time.

When looking at the AIR for both Mavorixafor and the placebo, we can see that Mavorixafor had an average of 1.8 infections per year while the placebo had 4.1, a roughly 60% decrease. During the first 6 months of the trial Mavorixafor participants experienced on average 3 infections, while placebo participants experienced 4.5. However, during the second 6 months the gap becomes larger, with Mavorixafor participants experiencing .8 infections, while placebo participants experienced 4.9. This not only shows how effective Mavorixafor is at reducing infections, but it also shows the durability of the drug's effects.

https://preview.redd.it/zqmuuk9s6vvc1.png?width=949&format=png&auto=webp&s=03047d41581dbe2ec85fe78276b78532eb52902c

Examining the AIR subgroup data reveals that all subgroups experienced substantial benefits from Mavorixafor compared to the placebo. The average infection rate was consistently below 0.5, with no advantage given to the placebo*. This shows that Movrixafor maintains a high level of efficacy across various patient subgroups, which was one of the main goals of this study.

*the average infection rate showed no advantage

Patients with WHIM syndrome experience frequent upper respiratory tract (URT), lower respiratory tract (LRT), and skin infections, significantly impacting their quality of life, even compared to individuals without WHIM syndrome. While the placebo has demonstrated some reduction in many infections, Mavorixafor has shown a clear advantage, with certain infections reduced by 100%, and URT, LRT, and skin infections reduced by 60% to 100%. Mavorixafor has proven more effective than the placebo in reducing infection frequency in all areas, except for genital infections.

https://preview.redd.it/e9byy9uv6vvc1.png?width=904&format=png&auto=webp&s=04a86e83e7a79fbd6103ece02a2f0b2bcb23b4bf

Infections: Duration (Phase 3 Only):

On average, WHIM patients spend 1-2 months in and out of infections, significantly affecting their day-to-day lives. The placebo drug has effectively reduced this infection duration to an average of 49.1 days, or approximately 7 weeks, consistently. However, Mavorixafor has demonstrated even greater efficacy by reducing infection time to 14.1 days, a duration similar to that of an average adult male.

https://preview.redd.it/68qib3yx6vvc1.png?width=1158&format=png&auto=webp&s=2a88abb7d6086dec307172e617c4062374c46298

Safety (Phase 3 Only):

Mavorixafor's overall safety was reviewed by an independent third-party board, ensuring unbiased evaluation of the drug's safety profile. Overall, Mavorixafor demonstrated good safety standards, with no treatment-related serious adverse events (SEAs), toxicity issues, or discontinuations due to drug-related concerns. Additionally, Mavorixafor has sufficient safety to be recommended for chronic or continuous dosing over a long period of time. While Mavorixafor had some TEAE cases, it did not exceed any predetermined safety barriers and is on par with other WHIM syndrome treatments.

https://preview.redd.it/pbunrml07vvc1.png?width=1145&format=png&auto=webp&s=90100fecef9a508fcec3618ba724d1c582038fbb

Risks:
There are two major risks that I identified with this investment:

1. No formal report about the manufacturer has been released.
2. Stock offering/Dilution after PDUFA approval.

Risks: Unknown Manufacturer:

XFOR has not released any information about the manufacturer for Mavorixafor, leading to significant uncertainty for investors. The inability to conduct fundamental analysis on the manufacturer would increase the risk with this position. Past instances, with issues with the manufacturer resulted in FDA denying PDUFA and causing the stock price to plummet (ex. IBRX).

Risks: Stock Offering/Dilution:

Currently, XFOR has 10.5 months of cash left, based on the estimate of $24.13 million burned per quarter (according to the dilution tracker). While this is a large amount of cash for a biopharmaceutical company, it's important to note that XFOR is still a company without any revenue or profits. XFOR could use the boost in stock price to do a stock offering, which might result in a sudden crash in the stock price.

https://preview.redd.it/yennw2d27vvc1.png?width=1334&format=png&auto=webp&s=e2bb73d0c68454dc23e3c9cd41d42c8eb7605c46

Conclusion:

In conclusion, Mavorixafor has a high chance for FDA approval. It has consistently demonstrated the ability to significantly increase ALC, ANC, and WBC in the bloodstream, sustaining this increase for an average of 16 hours. Moreover, Mavorixafor has effectively reduced the severity, frequency, type, and duration of infections in WHIM syndrome patients, on par with levels observed in adult human males. Additionally, Mavorixafor has shown similar or better safety profiles compared to the placebo.

However, a major concern is the lack of transparency on the potential manufacturer of Mavorixafor. This introduces significant risk and uncertainty into this investment idea.

Overall, given the data presented by XFOR, FDA approval appears highly likely and an investment may be a worthwhile thought.

Resources:
https://www.cancer.org/cancer/diagnosis-staging/tests/understanding-your-lab-test-results.html#:~:text=The%20most%20important%20infection%2Dfighting,is%20between%202%2C500%20and%206%2C000.
https://investors.x4pharma.com/static-files/294fc5c0-07ad-40f2-8a4c-d287f1645bcd
https://investors.x4pharma.com/static-files/3d2bee49-9860-464e-993d-ff5ee628efaa
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9700649/
https://www.genome.gov/genetics-glossary/Lymphocyte#:~:text=Lymphocytes%20are%20cells%20that%20circulate,destroy%20invading%20viruses%20or%20bacteria.
https://www.mountsinai.org/health-library/tests/wbc-count#:~:text=Normal%20Results,provider%20about%20your%20test%20results.
https://pubmed.ncbi.nlm.nih.gov/32870250/
https://primaryimmune.org/understanding-primary-immunodeficiency/treatment/immunoglobulin-replacement-therapy#:~:text=Ig%20replacement%20therapy%20treats%20antibody,of%20blood%20that%20contains%20antibodies.
https://primaryimmune.org/understanding-primary-immunodeficiency/types-of-pi/whim-syndrome#:~:text=is%20WHIM%20syndrome%3F-,Warts%2C%20hypogammaglobulinemia%2C%20immunodeficiency%2C%20myelokathexis%20(WHIM)%20syndrome%20is,%2C%20ear%2C%20and%20skin%20infections.

https://www.mayoclinic.org/symptoms/neutropenia/basics/definition/sym-20050854#:~:text=Neutropenia%20

https://rarediseases.org/rare-diseases/whim-syndrome/#:~:text=Common%20infections%20in%20children%20with,dental%20cavities%2C%20and%20infection%20of
https://toolbox.eupati.eu/glossary/treatment-emergent-adverse-event/
https://dilutiontracker.com/app/search/XFOR

https://www.researchgate.net/figure/Common-Terminology-Criteria-for-Adverse-Events-CTCAE-v50-tool_tbl1_354979209
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2673024/
https://www.lung.org/lung-health-diseases/lung-disease-lookup/facts-about-the-common-cold#:~:text=A%20cold%20may%20last%20for,Common%20Cold%20Symptoms

https://www.sciencedirect.com/science/article/pii/S0006295223005142

Disclosures:
I have used chatgpt and other AI services with the help of research, grammar, and sentence structure. All data has been corrected to the best of my ability, but some information may still be wrong.
I have no position in XFOR but plan to build a position. Please note this could be a potential conflict of interest.
Investment involves risk (including significant loss on investment) and do your own research before investing.

Some good news for $TARO long holders! Taro Pharmaceutical agreed to settle $36 million with investors for hiding generic drug price-fixing that led to a drop in stock price upon news of the DOJ antitrust investigation. You can check if you are eligible and submit for payout here.

• Cormedix is a Biotech company that primarily focuses on the Prevention of Catheter Related Blood infections with their leading Product Defencath. Catheter Related Blood Infections plagues the End Stage Kidney Disease population. According to the National Institute of Diabetes and Digestive and Kidney Diseases institute, nearly 808,000 people suffer from this ailment, and approximately 69% are on dialysis. (https://www.niddk.nih.gov/health-information/health-statistics/kidney-disease#:~:text=Nearly%20808%2C000%20people%20in%20the,31%25%20with%20a%20kidney%20transplant.))
•  Defencath is a catheter lock solution that eliminates gram positive and gram negative bacterial infections that develop within the catheter. It is composed of a solution of taurolidine and heparin that effectively reduces the CRBIS events in this vulnerable population. However, this population has a catheter that is surgically implanted into the patient, and it’s called, “a Central Venous Catheter.” This type of catheter is placed near a large central vein most commonly, internal jugular or subclavian or femoral. In layman terms, it’s placed near the patient’s heart, in a large vein to administer medication or to administer hemo-dialysis.
• The results of their Lock-It 100 Study, had an efficacy rate of .0006 with a 71% Reduction in CRBIs compared to the control. This was so significant that the phase three study was halted. (https://pubmed.ncbi.nlm.nih.gov/37678222/). You can find more specific information regarding Catherter Related Blood infections on the Company’s website with their most recent deck here. ( https://cormedix.com/wp-content/uploads/2023/03/CorMedix-Corp-Presentation_1-7-23.pdf)
• As of November 15, 2024 Cormedix received a NDA approval for the Limited Population of adult patients affected by kidney failure.( https://cormedix.com/cormedix-inc-announces-fda-approval-of-defencath-to-reduce-the-incidence-of-catheter-related-bloodstream-infections-in-adult-hemodialysis-patients/#:~:text=About%20CorMedix&text=DefenCath%20has%20been%20designated%20by,address%20an%20unmet%20medical%20need.))
• Moreover, Cormedix Secured J-Codes for In-patient and out-patient settings, Jan 30, 2024 and April 9, 2024. (https://cormedix.com/cormedix-inc-announces-commercial-and-reimbursement-updates/) and(https://cormedix.com/cormedix-inc-announces-commercial-agreement-with-arc-dialysis-llc/)
• Cormedix also secured TDAPA reimbursement from CMS for the out-patient setting on April 19, 2024. (https://cormedix.com/cormedix-inc-announces-cms-grants-tdapa-to-defencath/) Lastly, Cormedix Celebrated it’s commercial launch for the in-patient setting on April 15, 2024. (https://www.globenewswire.com/news-release/2024/04/15/2862768/0/en/CorMedix-Inc-Announces-U-S-Inpatient-Commercial-Availability-of-DefenCath-Taurolidine-and-Heparin.html)
• Why is Cormedix a Deep Value opportunity to add to your portfolio today, while it’s trading as of Apr 19, 2024, at 5.20 per share at close. CEO Joe Todisco currently owns 352,000 shares, and added to his position with approximately 13,561 shares on March 13, 2024 at $3.74.  Additionally, other insiders have not sold any shares over the past few years. I heavily weight insider ownership when the Officers heavily own shares, whether awarded or granted in lieu of payment. You can see all insider holdings here, (https://www.nasdaq.com/market-activity/stocks/crmd/insider-activity). 
• The institutional ownership owns about 33.94% of total shares on the open market, with the leading institution being Blackrock Inc., at 3,507,695 million shares held as of 12/31/2023. Numora Holdings Inc, comes in second at 2,946,552 million shares, then Vanguard at 2,825,335 million shares held. Coming in at 4th Place is Elliot Investment Management L.P., at 1,550,523 million shares held. For additional Institutional ownership see,  (https://www.nasdaq.com/market-activity/stocks/crmd/institutional-holdings)
• How does Defencath work and what are the projected vials to be sold? Cormedix projects about 3,400,000 million vials to be sold on the in-patient side and over 37 million vials on the out-patient side. This growth potential is HUGE! Well, with such volume, you’re probably wondering how the product exactly works. Every time a patient receives hemo-dialysis the catheter must be flushed with the Defencath solution before and after. That is approximately two vials per patient at least three times a week. The hemo-dialysis out-patient population is roughly about 550,000 people. 
• Cormedix plans, and is on tract, to launch defencath for the out-patient Setting on July 1, 2024.
• Cormedix plans on expanding it’s usage and application of Defencath to other populations that already have CVCs. One example is Oncology. 
• Current short Interest as of March 31,2024 is 34 million dollars or approximately 8, 200,000 million shares shorted. 
• Disclosure I own contracts, exp June 2024, and I own approximately 4,000. Shares. 
• The projected market impact of this stock is incredible. And Understanding the product shows the extreme value it holds. 
• Good Luck!
• This is not Trading advice, this just my opinion about Cormedix.

I posted about the settlement already, but since it's not so much time left to file (deadline is in May), I decided to post it again.

Short story: So I guess you heard about the scandal with COVID-19 vaccine. In the old Covid times Novavax received $1.6B from the government for its development and then faced challenges (many) meeting quality standards. Production problems in 2021 also led to lower vaccine quality, displeasing the FDA.

After that, investors claimed that Novavax downplayed these issues and overstated its manufacturing capabilities and hit Novavax with the lawsuit.

And not so long ago Novavax decided to pay a $47 million settlement to resolve this, so, if you traded NVAX and were damaged somehow, you can check it out.