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aponia_analytics

@AponiaAnalytics

Stay informed on the forces shaping global health. Holistic Intelligence in Healthcare. Industry Blog. By Anton Baysa, M.D., Ph.D.

Oslo, Norway Joined Temmuz 2024
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aponia_analytics
aponia_analytics@AponiaAnalytics·
Welcome to @AponiaAnalytics 🦉🦉🦉 Curious about how emerging diseases and breakthrough innovations shape tomorrow’s healthcare worldwide? Follow along for the latest news, real-time trends, and unbiased analysis. 🦉📈💊⚕️ Your provider of holistic intelligence in healthcare and biotech. We cover: - #BreakingNews in biotech, medtech, and healthcare. - Health threat reports, emerging #diseases, #outbreaks, #epidemiology. - #MarketAnalysis - Trending companies and #startups. Follow us! @aponia_analytics team 🦉🦉🦉
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aponia_analytics
aponia_analytics@AponiaAnalytics·
$IBRX #ANKTIVA
Freedom@ActionFixesFear

$IBRX Someone's father is dying of pancreatic cancer right now. 1.9 million Americans are diagnosed with cancer every year. Last year, 3,745 of them received ANKTIVA. One subtype of bladder cancer. That's it. 34 other countries looked at the same data and approved more. The molecule that could help was ranked #1 by the government in 2007. The scientist who discovered the cells it activates had his funding canceled. He died before seeing the drug approved. A 13-year-old flew across the country for treatment and didn't survive. 13,000 Americans called begging for access after one TV interview. The FDA Commissioner gave the man who built it 10 minutes. @DrPatrick built the weapon anyway. 34 countries. 13 tumor types. Sepsis. Cancer prevention. The 3-year plan isn't a cancer plan. It's an immune restoration plan. This is the weapon. This is what it cost. And this is the plan to make sure no one runs out of time again. THE ORIGIN In 1969, a doctor at MD Anderson named Joseph Sinkovics drew his own blood, mixed it with a cancer patient's tumor cells, and watched under a microscope as his lymphocytes killed them. He had no cancer. His blood destroyed the tumor cells anyway. He photographed the moment - December 3, 1969. The first images ever taken of what we now call natural killer cells attacking human cancer. The NCI reviewed his work. Called it an "in vitro artifact." Canceled his grant. Sinkovics spent the rest of his career proving they were wrong. He never saw ANKTIVA approved. In 2007, the same NCI ran a workshop on immunotherapy agents. They reviewed 240 molecules and ranked them by potential to impact cancer. The molecule ranked #1 was interleukin-15 - IL-15. The body's own signal to grow and activate NK cells and T cells. Nobody built the drug. In 2008, Patrick Soon-Shiong read Sinkovics' chapter. The discovery. The rejection. The decades of institutional silence. And he started building what would become ANKTIVA - an engineered superagonist of IL-15 that stays active long enough to wake up the immune system. In 2013, the first patient was dosed. In April 2024, the FDA approved it. For one subtype of bladder cancer. One indication. One country. Between the ranking and the first approval: seventeen years. Between Sinkovics' photograph and the first approval: fifty-five years. And during those years, people were dying of diseases this molecule could fight. THE COST A 13-year-old boy from Butler, Pennsylvania - the same town where Trump was shot - was diagnosed with metastatic pancreatic cancer. His family called PSS. Local doctors said hospice. PSS flew the boy to LA. On Tucker Carlson's show, he said: "The greatest surprise to me was a 13-year-old with metastatic pancreatic cancer. By the time he came to see us, his body was ridden and he passed away." Sean Spicer's own father died of pancreatic cancer. When he interviewed PSS, he said: "My father at the time was dying from pancreatic cancer. So it was personal to me." The man asking the questions had already lost someone to the disease the man answering the questions was trying to cure. Alina Kidd's ex-husband was diagnosed with colon cancer in 2020. He died in 2023. Then she was diagnosed with the same cancer. Stage 3B. Three rounds of chemo, radiation, multiple surgeries - the cancer kept coming back. Her oncologist referred her to PSS. She's been on ANKTIVA since August 2025. Her lymphocytes are rising. Her radiation-induced inflammation resolved. She hasn't had a cold or flu since starting treatment. Her ex-husband didn't have that option. He died one year before ANKTIVA was approved. After the Tucker Carlson interview aired, 13,000 Americans called asking for treatment. PSS went to the FDA Commissioner. The Commissioner gave him 10 minutes. The science existed. The molecule was ranked #1. The weapon was being built. People died anyway - because institutions move slower than cancer. EVERY FRONT On February 23, 2026, PSS filed a 3-year expansion plan with the SEC. Not a cancer plan. An immune restoration plan. Thirteen tumor types, twenty-five active trials, a sepsis program, a cancer prevention program, and global deployment across 34 countries. Six weeks later, the checklist is already firing. Bladder cancer - the approved indication. At the Citizens Life Sciences Conference, CEO Adcock put three drugs on one slide. Nadofaragene: 9.7 months. Keytruda: 16.2 months. ANKTIVA: 53+ months, median not reached. Surgeons trained with scalpels are choosing immunotherapy over surgery. The Phase 1b patients - six out of six - are still in complete remission at 8.8 years. The BCG-naive trial hit its milestone, the IDMC confirmed enrollment is sufficient, BLA filing targeted Q4 2026. That's the entire bladder cancer market opening. Lung cancer - survival tripled: 21 months versus 7 months with chemotherapy. The lung cancer patient from Arizona was given six to eight weeks to live. She told the camera: "My doctor had said, you have six to eight weeks to live if we don't do this. I didn't hear that." Three and a half years later, she's running harvest festivals with her granddaughter. Tumors gone from her right lung, shrinking in her left. Saudi Arabia approved it in January 2026 - the first country to approve ANKTIVA beyond bladder. Pancreatic cancer - the cancer that killed the boy from Butler. That killed Spicer's father. Twelve percent five-year survival rate. The FDA granted RMAT fast-track for the ANKTIVA + CAR-NK combination. A metastatic pancreatic cancer patient treated by PSS has been free of disease for six years. Six years, with a cancer that kills most people in months. Neoadjuvant first-line trial active. GBM - the brain cancer that killed John McCain, Beau Biden, Ted Kennedy. Enrollment complete. Two new randomized trials planned. Lymphoma - CD19 CAR-NK cells combined with ANKTIVA. At the Citizens conference, Adcock said physicians are telling him "this is working" - not a bridge to transplant anymore. It's the treatment. Lynch syndrome - one in 278 Americans carry it. Eighty percent increased lifetime risk of colon and endometrial cancer. The NCI chose ANKTIVA for the prevention trial. 138 patients enrolled. First data in - ANKTIVA raises lymphocyte counts, confirming the thesis. This isn't treating cancer. This is stopping it before it starts. Sepsis - the newest front. 200,000 Americans die every year. No approved immunotherapy. In 2010, researchers proved IL-15 blocks the destruction of NK cells during sepsis. The paper sat for 16 years. PSS filed a Phase 3 trial on April 1 - ANKTIVA + iNKT cells for severe pneumonia and sepsis. Starts April 15. Radiation - B-2 bomber pilots are getting prostate and breast cancer from radiation exposure in their own aircraft. Radiation wipes out NK cells. ANKTIVA restores them. The military use case nobody talks about. Cancer: activate NK cells to kill tumors. Sepsis: stop bacteria from killing them. Radiation: restore what the exposure destroyed. Lynch syndrome: keep the immune system strong enough that cancer never starts. Same molecule. Different battlefields. THE VALIDATOR On March 2, five experts sat on a NewsNation prime-time stage with Chris Cuomo. The topic: "Why Can't We Cure Cancer?" One of them was Dr. Jay Bhattacharya, the Director of the National Institutes of Health. He told the audience: "When I was a medical student in the 90s, the idea of immune therapy was science fiction." Then PSS reached into his papers and pulled out a physical document - the 2007 NCI report that ranked IL-15 first out of 240 molecules. He held it up and told the audience he was showing it to the NIH Director for the first time. "The National Cancer Institute and the thought leaders of the country have known for close to 20 years exactly what Jay said - the most important molecule in your body, secreted by your body, is IL-15, so that it can grow T cells and natural killer cells." Bhattacharya looked at the paper. Then validated immunotherapy on national television. He confirmed that FDA Commissioner Makary is opening a new approval pathway based on "plausible biological mechanisms." That's ANKTIVA's route. Jim Johnson sat on the same stage. Sixty-six chemo infusions. Twenty radiations. He looked at the audience and said: "I have no cancer in my body." The next morning, the NIH Director amplified the special on his own feed. The day after, PSS held his first-ever earnings call. The investment community had already seen the NIH Director sitting beside him - not across from him as a regulator, but next to him as a peer. THE MAP Now look at the map. The FDA approved ANKTIVA for one subtype of bladder cancer in one country. Since then, the world decided for itself. UK: July 2025. Saudi Arabia, bladder and lung: January 2026. EU: February 2026. Macau, first in Asia: March 2026. Thirty-four countries. Serum Institute of India: 100+ emerging markets. Accord Healthcare: Europe. BeiGene: China. A Saudi subsidiary for, in PSS's words, "all the Middle East and all of Africa." The NCI ranked IL-15 first. In 2007. The FDA approved it for one thing. In 2024. In the two years since, 33 more countries looked at the same data and didn't wait. THE WEAPON 1969 - Sinkovics photographs NK cells killing cancer. NCI cancels his grant. He dies without seeing the drug approved. 2007 - The same NCI ranks IL-15 first out of 240 molecules. Nobody builds it. 2008 - One man reads Sinkovics' chapter and starts building. 2010 - Researchers prove IL-15 saves lives in sepsis. The paper sits for 16 years. 2013 - First patient dosed. 2024 - FDA approves. One subtype. One country. Across America, patients with cancers this molecule could fight are running out of time. 2025 - UK, Saudi Arabia approve. Tucker Carlson, Megyn Kelly, Jon Stewart, Chris Cuomo, Fox News prime time. Thirteen thousand Americans call asking for treatment. PSS on Cuomo's Killing Cancer special: "I just would like to see it in my lifetime." February 2026 - The NIH Director sees the 2007 report on live television and validates immunotherapy the next morning. The EU approves. Thirty-four countries. March 2026 - The 3-year plan is filed. Thirteen tumor types. Twenty-five trials. Sepsis enters the battlefield. Sinkovics wasn't here forever. Spicer's father wasn't here forever. The boy from Butler wasn't here forever. The cost of waiting is measured in lives. It always was. THE HOPE The 3-year plan is in full motion. Every week another line item fires. Here's what most people haven't seen yet. Beyond the seven fronts covered above, the plan lists six more cancer types in active development: Liver cancer - planned randomized trial combining ANKTIVA with zabadinostat and a checkpoint inhibitor. Second-line and beyond. Colorectal cancer - Phase 3 randomized trial. ResQ203D-CRC. Triple-negative breast cancer - Phase 2 completed. Planned randomized trial with a Trop2 antibody. The most aggressive form of breast cancer, the one with the fewest options. Ovarian cancer - platinum-resistant patients receiving M-ceNK cells (manufactured NK cells). Phase 2 active. Prostate cancer - randomized trial specifically for radiation-induced lymphopenia. This is the military connection: pilots, radiation workers, anyone whose immune system was destroyed by the treatment that was supposed to save them. Multiple myeloma - planned single-arm trial in relapsed patients. Then there's the biggest addressable market of all: pan-tumor lymphopenia. One in five Americans - 52 million people - suffer from low lymphocyte counts. ANKTIVA is the only approved molecule that restores them. The Epogen argument: nobody asks which cancer type when prescribing Epogen for low red blood cells. ANKTIVA restores NK cells and T cells. Why should the FDA require cancer-type-specific approval for immune cell restoration? 570 patients are already on expanded access across 58 sites. 64 subjects have completed apheresis for the M-ceNK robotic manufacturing platform. Patents protect the ANKTIVA + checkpoint inhibitor combinations through 2035 and beyond. The infrastructure: $113 million revenue, 700% growth, $375 million non-dilutive capital from Oberland, 691 employees, global distribution on four continents. The approvals: 34 countries. UK, Saudi Arabia, EU, Macau. Serum Institute for India and 100 emerging markets. BeiGene for China. Accord for Europe. A Saudi subsidiary for the Middle East and Africa. The weapon was always IL-15. The plan is how it reaches everyone in time.

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aponia_analytics
aponia_analytics@AponiaAnalytics·
$LQDA
Alpha Hunter@AlphaHunte79332

By our estimates, $LQDA exceeded 4,000 scripts on April 1st, which puts annualized revenue (85% compliance at 235k and ignore the 1 month free) at $800mm - that gets you to $4-$5 in annualized earnings at the start of Q1. We could very well see +$10 next year for 2027. Now of course this incredibly profitable growth trajectory (who else has seen a product launch like this in the history of their investing careers) is obscured by the litigation overhang. Judge Andrews went passed the March 31st deadline, which many felt he would not do. Given the bench trial was in June and there was expedited briefing, the original timing was expected in September/October and we are now in April - so what gives? It is hard not to look at this as at the very least a slight positive to extreme positive tell for $LQDA. He asked for expedited briefing and if he wanted to rule against $LQDA, he would have done so quickly to get to the remedy stage quickly and have the least amount of effect on patients. We are now at the stage where there are several thousand vey sick patients on this drug and if anything were to happen to them it would be a national news story. It appears less and less likely that Andrews is set to do something that would be very disruptive. It appears more likely instead that we see a clean win for $LQDA and that view was bolstered by this recent Amazon opinion that he put out which was 50 plus pages. In this decision, Andrews spoke to this idea of forfeiture and this ties directly to the $LQDA case. Amazon like $UTHR tried to make an argument after the fact - in $UTHR's case they did it in their subsequent briefing rather than at trial. They had a burden of production, that is to come up with all of their best arguments on an issue, which they clearly did not meet (they just had Dr. Byrd speak off hand in a cursory manner). They met that burden of production after the fact but not in the interregnum or in the trial, which is what we you are supposed to do. Our thinking is that given the $AMZN case was a bit older and he needed to spoke to a similar issue as the $LQDA case, he wants to get through it first before speaking on $LQDA. It has been very hard to predict timing, so we will not try, but we could still very well see a ruling here for $LQDA in the next two weeks now that he has his $AMZN opinion on it and the structure of that ruling will look similar.

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