Diamyd medical AB (ISIN number SE0005162880) publishes a summary which they call “Company Presentation”. It is updated a few times a year "before upcoming important events". Last update was January 31, 2025.

https://www.diamyd.com/docs/companyPresentations.aspx

I am not a completely unskilled reader of scientific text, I hope you have higher competence than me.

Let me offer some thoughts on how that presentation should probably be read.

Pages 17 - 22 have very interesting pictures about HLA, the importance for all studies with GAD-65 which were completed and Diagnode-2 which was finished after the article in Diabetologia was published.

The problem is that the images have been downloaded "unedited" from scientific articles and all 3 articles use completely different ways of describing the same thing. For example, having or not having DR3- DQ2 is described as positive/ negative - presence/ absence.

DR4-DQ8 having or not having is being described fascinatingly complicated on page 17;

“DR4-DQ8 gene (super responder patients)”

Expressed in the table by “Absence of HLA DR3-DQ2/X; X is not DR4-DQ8""

Most interesting table values ​​are given logarithmically (compare with Decibel)

The images usually have p=. The p= values ​​on page 19? ? There the source must be read to become wise as to what they are referring to.

Generally speaking, the scientific articles must be read in their entirety for full understanding.

Hey guys, if you missed it, NVAX recently announced that the first participants have been dosed in its COVID-19-Influenza Combination and stand-alone seasonal influenza Phase 3 trial. We’ll have to wait to see their results in a few months. That’s a great win after the issues they had with their Covid vaccines a few years ago.

Long story short, in the old Covid times, Novavax received $1.6B from the government for the Covid vaccine development. But then, the company faced many challenges in meeting quality standards. All these production problems 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.

The good news is that Novavax recently agreed to pay a $47M settlement to investors to resolve this scandal. And if anyone is late, I found out that you can still file for it, they´re accepting claims even after the deadline. 

Now, NVAX is working with the FDA to determine the potential of the current CIC and seasonal influenza trial to support accelerated approval. Hopefully, this will work out for them.

Anyways, has anyone here had $NVAX when this happened? If so, how much were your losses?

Aurora Cannabis made its NYSE debut in October 2018 with bold promises of dominating the cannabis industry. Its stock soared to over $1,200 in early 2019, fueled by ambitious growth plans and acquisitions.

But by late 2019, analysts raised red flags about oversupply in the Canadian market, inventory backlogs, and regulatory challenges. Aurora missed profitability targets in September 2019, reported a 25% revenue drop by November, and paused construction on major production facilities.

Adding to investor concerns, the company was accused of inflating financial metrics with a $21.7M “round-trip sale” of cannabis biomass. By the end of 2019, Aurora’s stock had plummeted over 73%, wiping out $4 billion in shareholder value.

These issues prompted a class-action lawsuit, with investors accusing Aurora of making false and misleading statements about its financial health and growth prospects.

Now, Aurora has agreed to an $8.05M settlement to resolve the claims. So, if you bought shares between October 2018 and February 2020, you might be eligible to file a claim and recover some of your losses.

Also, Aurora has shifted focus to its international medical cannabis business as part of a transformation plan. The company recently reported a 30% year-over-year increase in global medical cannabis revenue, signaling progress. However, its stock still trades far below its early highs, hovering around $4.10 per share as of December 2024.

Anyways, for those who held $ACB shares during the collapse, how much did you lose?

Globus Medical holds a 17.9% share of the spine implants market and has grown revenue at a 38.76% CAGR, significantly outpacing competitors. This investment case explores whether the company is well-positioned to continue its growth.

https://preview.redd.it/6146dvobfcge1.png?width=522&format=png&auto=webp&s=960419e7569746c8fc9c33f4d79ced1735f085dd

It is a little strange that diabetes researchers and the FDA see the smoke but not the investors.

For those who want to be one step ahead, there is an updated analysis (so far only in Swedish, but the .pdf can be translated by Google translate. Normally, the English version will come with time (as well as the quarterly reports do))

The analysis is ordered and paid for by Diamyd medical AB (ISIN number SE0005162880).https://researchdocs.carnegie.se/research/2025/01/30/dmydb20250130.pdf

Previous analyzes can be found at this addresshttps://www.carnegie.se/en/commissioned-research/diamyd/

In Sweden, the analysis is met with disbelief and is explained away by saying that the analysis firm cannot set a higher target price because then there will be unlikely differences between the justified target price and the traded price.

Personally I argue again that the analysis does not reflect the manufacturing facility in Umeå's value. (manufacturing external assignments (study drugs))

They also do not affect the redemption of TO4 warrants (SEK 16), which should have a large influence on the share's valuation.

After the quarterly report, CEO Ulf Hannelius held a 1-hour (Microsoft Teams) presentation (Swedish language) where 40 minutes were set aside for questions. The meeting ended 10 minutes before the appointed time when we had received answers to all questions.

Worth passing on (free from memory) is that DMYD has re-evaluated the number of patients to treat with GAD-65 if becoming a registered medicine. Most likely, those diagnosed in the last 3 years will be eligible for treatment. As well as LADA which is diagnosed first as Diabetes type 2 and re diagnosed on antibody titers to LADA before requiring external insulin. That means it will be a stage 2 treatment.

LADA and TD1 are considered equal in size. Then it gives 2 blockbusters for 3 years cohorts.

Prevention stage 1 and stage 2 is still not completely clear how it will be handled? New studies for how long?

Doing time-long studies in Stage 1 that may never lead to a TD1 diagnosis. Then the study participants were cured, while those who did not participate in the studies received their diagnoses and life-long medication with insulin year after year.

CEO Ulf Hannelius allowed himself to say that the cooperation with the FDA takes place in a spirit where the FDA "wants to GAD-65 shall reach approval”

Saniona, with a current market cap of $72 million USD, holds significant potential for substantial growth from current levels. Probably one of the most obvious undervalued stocks you will come across in a while. Saniona's ticker symbol is SANION, and it is traded on Nasdaq Stockholm under this designation. Saniona holds the global commercial rights to Tesofensine one of the most effective and safest available oral treatments for obesity—is awaiting potential approval for its weight-loss drug in Mexico, which could come at any moment.

Tesofensine

• Saniona holds the global commercial rights to Tesofensine, which is one of the most effective and safest orally available treatments for obesity, having been tested in over 1,600 patients across approximately 20 studies.Phase 3 results for Tesofensine demonstrated an average weight loss of 10% after 24 weeks, with a very favorable safety profile.

Results from a previous study involving 203 obese patients treated with Tesofensine, published in The Lancet.

• The company has a license agreement for Tesofensine with Productos Medix, providing five years of exclusivity in Mexico and Argentina.
• The Mexican regulatory authority's technical committee on new molecules has provided a favorable opinion on Saniona's Tesofensine, signaling that final approval could be granted in the near future.

Update 22/1 2025 on the dialogue between Medix and the Mexican regulatory authority, COFEPRIS. This could be related to Tesofensine.

• Although the Tesofensine patent has expired, the company can still out-license the compound with exclusivity in various regions, as they have done in Mexico and Argentina.
• According to the company, final approval in Mexico could open up the markets for Tesofensine in Colombia, Chile, and Argentina without the need for additional studies. There has also been significant interest from Brazil, although the company or a partner may need to conduct a supplementary study there.

AMLAC is a South American equivalent of the FDA and EMA, focusing on harmonizing drug approvals and ensuring the safety, efficacy, and quality of medicines in the region.

• Saniona’s compound Tesomet ( Fixed-dose combination therapy of Tesofensine and Metoprolol ) has received Orphan Drug Designation for both Prader-Willi syndrome and Hypothalamic obesity. It has completed two separate Phase 2 studies for each indication, showing very promising and positive results in both cases. Patent until 2033 with Tesomet.

Very promising and positive results in both indications

SAN711 - Acadia

• In November 2024, Saniona signed a deal with Acadia worth up to $582 million USD, with $27 million upfront, for Saniona's Phase 1 candidate SAN711. Upfront was at that time as big as the current market cap.
• SAN711 is, to our knowledge, the first and only positive allosteric modulator of GABA-A receptors that acts selectively on α3 receptors, unlike existing molecules that affect all GABA-A receptors. This could lead to potential treatments for several indications.

With a $27 million upfront payment

Exceptionally selective

SAN711 Maintains Efficacy in treating pain after repeated dosing - in Contrast to Morphine

Very promising effects in alleviating nerve injury without leading to sedation or the risk of abuse

SAN2355 - KV7

• Kv7 compound (SAN2355), which, according to the company, is a unique molecule with an unparalleled subtype selectivity profile among Kv7 channels.
• The company expects to start a Phase 1 study with the KV7 epilepsy candidate SAN2355 in the third quarter of 2025.

Unparalleled subtype selectivity profile among Kv7 channels.

Plattform and pipeline

• The ION BASE platform, which includes approximately 120,000 compounds, 20,000 of which are proprietary, has resulted in 12 partnerships generating around $75 million USD and several spinouts over the past 10 years. Some of the partnerships include companies such as Boehringer Ingelheim, Medix, Janssen, Cadent, and Pfizer.

The ION BASE platform

Current pipeline

I have highlighted just a few of Saniona’s compounds; they have many more, including ongoing collaborations with AstronautX in Alzheimer’s disease, Boehringer Ingelheim in schizophrenia, and Cephagenix in migraine. Saniona is well-known in the CNS field as a leader in the discovery of highly specific ion channel modulators. Their unique combination of an effective platform and assets in both early and late-stage development sets them apart.
Peers have valuations many times higher than Saniona’s current valuation.
Given the current extremely low valuation, a potential approval in Mexico could cause the stock to explode dramatically.

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(08)61525-1/abstract

https://saniona.com/pipeline/

Hey guys, any Viatris investors here? I posted about this settlement before but since Viatris is still accepting late claims for their $16M investor settlement, I decided to post it again. It’s connected with the Mylan merger fallout.

For newbies: Back in 2020, Viatris merged with Mylan, issuing 560M new shares to Mylan investors. But then, Viatris was accused of hiding info in its Registration Statement—downplaying risks like weak performance in China due to political tensions and intense competition in Japan.

When these issues came to light, Viatris’ stock lost nearly $1B in value, leading to an investor lawsuit (not a surprise at all, lol)

The good news? Viatris recently agreed to a $16M settlement and late claims are still being accepted. So, if you were affected by this, you can still file for payment here or through the settlement admin.

Anyways, did anyone here invest in Viatris or Mylan back then? How did it impact you?

The healthcare industry has undergone profound transformations over the past decade, with regenerative medicine emerging as a key frontier. This innovative field focuses on harnessing the body’s intrinsic ability to heal, aiming to replace or regenerate human cells, tissues, and organs to restore normal function. Regenerative medicine holds the potential to revolutionize treatment for a multitude of conditions—from neurodegenerative diseases and spinal cord injuries to cardiovascular disorders. As 2025 unfolds, the sector is expected to see a wave of breakthroughs that could redefine the future of medical care.

The Growth of Regenerative Medicine

Global investments in regenerative therapies have surged, with funding reaching over $45 billion globally in the past five years and projected to surpass $50 billion by 2025, growing at an annual rate of nearly 16%. Driven by advances in stem cell research, tissue engineering, and biologics, the number of active regenerative medicine companies has increased by over 200% since 2015. The rise of personalized medicine, alongside increased demand for treatments that go beyond symptom management, is fueling innovation. Among the subfields gaining traction are exosome-based therapies—a promising approach that utilizes extracellular vesicles derived from cells to promote healing and tissue repair, with over 100 clinical trials related to exosomes currently underway worldwide.

Unlike traditional cell therapies that directly implant live cells into patients, exosome-based treatments leverage the natural signaling properties of extracellular vesicles to influence cellular processes. These therapies show immense promise in conditions where direct cell transplantation faces limitations. Within this burgeoning area, companies like NurExone Biologic (TSXV:NRX, OTC:NRXBF) are at the forefront of pioneering advancements.

A Pivotal Year for Exosome-Based Therapeutics

2025 is shaping up to be a pivotal year for regenerative medicine as major global corporations and research institutions ramp up their exploration of exosome-based therapies. Companies such as Pfizer, AstraZeneca, and Merck have entered the space through partnerships, acquisitions, and large-scale funding initiatives aimed at accelerating breakthroughs in neurological rehabilitation and other areas. These efforts reflect growing industry confidence in exosome technology as a scalable solution for complex medical conditions. The market is closely monitoring advancements in safety, efficacy, and commercial viability as these developments could drive regulatory support and widespread adoption.

Introducing NurExone Biologic: A Trailblazer in Regenerative Medicine

NurExone Biologic (TSXV:NRX, OTC:NRXBF), an Israel-based biotech innovator, has established itself as a leader in developing cutting-edge exosome-based therapies aimed at treating traumatic spinal cord injuries (SCI) and other neurodegenerative disorders. The company’s platform harnesses the power of engineered exosomes to deliver therapeutic agents directly to damaged cells, promoting repair and recovery in unprecedented ways.

One of the company’s standout innovations is its proprietary ExoPTEN technology, which focuses on non-invasive delivery methods to target central nervous system injuries. This approach offers a safer and more effective alternative to invasive surgical interventions. NurExone’s exosome technology is poised to overcome significant challenges in the industry, such as achieving targeted delivery across the blood-brain barrier—a major hurdle in neurotherapeutics.

Major Milestone: Master Cell Bank Secured

On January 8, 2025, NurExone Biologic (TSXV:NRX, OTC:NRXBF) reached a significant milestone by securing its Master Cell Bank (MCB), a foundational step in scaling up production for clinical and commercial purposes. The announcement, shared via a press release, highlighted the company’s achievement in establishing a robust and scalable cell line capable of consistently producing high-quality exosomes for therapeutic use.

The development of an MCB is crucial for any biopharmaceutical company’s progression toward large-scale manufacturing. The Master Cell Bank acts as a genetic reservoir, ensuring the uniformity, potency, and safety of biologics produced in future batches. NurExone’s successful establishment of this MCB reflects its commitment to meeting stringent regulatory requirements and positions the company to advance its clinical programs with greater confidence.

Dr. Lior Shaltiel, CEO of NurExone, emphasized the importance of this milestone: “The creation of our Master Cell Bank not only underscores our scientific excellence but also reinforces our readiness to enter pivotal clinical phases. This achievement brings us closer to delivering life-changing treatments to patients suffering from spinal cord injuries and beyond.”

What Lies Ahead for NurExone in 2025

With its Master Cell Bank secured, NurExone (TSXV:NRX, OTC:NRXBF) is well-positioned to accelerate its clinical pipeline and pursue regulatory approvals for its flagship therapies. The company aims to initiate advanced clinical trials aimed at demonstrating the safety and efficacy of its exosome-based treatments in real-world settings.

Key areas to watch include:

1. Clinical Trial Progression: NurExone’s next phase of clinical trials will likely attract attention from both investors and the scientific community as data emerges on the outcomes of exosome-based therapies.
2. Regulatory Submissions: The company is expected to submit regulatory filings that could pave the way for investigational new drug (IND) approvals.
3. Strategic Partnerships: Partnerships with academic institutions, research centers, and pharmaceutical companies may expand NurExone’s reach and capabilities, further validating its technology.
4. Commercialization Plans: Depending on clinical results, NurExone may begin laying the groundwork for commercial launch strategies.

Broader Implications for the Industry

NurExone’s advancements underscore the broader trend within the biotech industry toward precision therapies that can target previously untreatable conditions. The success of exosome-based therapeutics could open new avenues for treating neurotrauma, chronic inflammatory diseases, and even age-related cognitive decline. As more companies enter the exosome therapy space, regulatory bodies will face increasing pressure to establish clear frameworks for evaluating the safety and efficacy of these novel treatments.

The Road to Transformative Healing

NurExone Biologic’s focus on addressing spinal cord injuries—a condition with limited treatment options—is emblematic of the potential regenerative medicine holds to transform lives. The company’s recent progress demonstrates the dedication of scientists and clinicians who are turning groundbreaking science into solutions.

2025 is set to be a defining year not just for NurExone (TSXV:NRX, OTC:NRXBF) but for the regenerative medicine sector as a whole. Pioneers like NurExone are reshaping the medical landscape, offering new hope through state-of-the-art technologies and clinical advancements.

Blankers (+0,4% last 3 weeks) are normally better informed than new investors. They do their Due Diligence and exploit the weak nerves of the ignorant.

2015 restarted Diamyd medical AB (ISIN number SE0005162880) studies with GAD-65 (Phase III narrowly missed significance in 2011).

They changed the way of administration and restarted with one OPEN Fas I (15-month follow-up). Open studies have NO placebo group.

https://clinicaltrials.gov/study/NCT02352974?term=diagnode-1&rank=1

To their surprise, they obtained results in 2 clearly defined groups that were conclusive if the placebo group had been slightly greater than the group receiving GAD-65.

Already at the beginning of the studies with GAD-65 had Åke Lernmark (Professor Lernmark has been a member of the Scientific and Medical Advisory Board since 1996.) Published scientific articles about antibodies against GAD-65 being able to bind to HLA.

https://www.sciencedirect.com/science/article/abs/pii/0198885993905256

Diagnode-1 was extended with the number of participants and some participants received Booster who were followed for 43 months.

Diagnode-2 was expanded with more participants and here, too, Boosters were given to those who answered best.

Diagnode-3 was redesigned "completely" and now only recruits those who have responded to the treatment. HLA DR3-DQ2 positive, and even better if HLA DR3-DQ2 positive and HLA DR4-DQ8 negative (so called “suprerresopners”)

Personally, I look forward to an almost 100% positive outcome where the participants will need much lower doses of insulin and less time with harmfully high blood sugar.

Notable here is that HbA1c, which is the second endpoint, is most likely a comparison with insulin pump software. A "genuine" placebo group had no participants survived.

Do I need to write that their C-Peptide is expected to be higher than the placebo group's.

Hey everyone, any $DNA investors here? If you’ve been following Ginkgo Bioworks, you probably remember the short-seller report that shook the company back in 2021. If not, here’s a quick recap of what happened—and the latest updates.

In 2021, Ginkgo Bioworks went public via SPAC, raising $1.6B and attracting major institutional investors.

However, in October 2021, Scorpion Capital released a report labeling Ginkgo a "colossal scam", alleging that most of its revenue came from related-party transactions and that many of its partnerships were overstated or misleading (they even mentioned some former employees’ testimonies).

When this news hit, Ginkgo’s stock fell 12% in a single day, and the DOJ launched an investigation the following month.

By November 2021, shareholders filed a lawsuit, accusing Ginkgo of inflating its revenue and hiding key risks. As you might know, Ginkgo has already agreed to settle, paying up to $17.75M to affected investors. If you bought $DNA shares between May 11, 2021, and October 5, 2021, you may be eligible to file a claim to recover some of your losses even though the deadline has passed.

Despite this settlement, Ginkgo's stock has continued its downward spiral, having lost over 97% of its peak value. Once worth nearly $30B, the company’s market cap has now dropped to around $825M.

Anyways, do you think Ginkgo can turn things around? And for those who held $DNA stock back then, how much did you lose?

Biotechnology is one of the most dynamic and impactful sectors in the global economy. From developing life-saving drugs to pioneering treatments for previously incurable diseases, biotech companies play a crucial role in shaping the future of medicine and healthcare. In recent years, investing in biotech has become an attractive opportunity for those looking for innovation-driven growth and the potential for significant returns.

The Case for Biotech Investments

The biotech industry is driven by scientific innovation, regulatory approvals, and market demand for groundbreaking therapies. Here are a few reasons why biotech investments are appealing:

1. Innovative Breakthroughs: Biotech companies are at the forefront of cutting-edge research, from personalized medicine to gene therapy and cell-based treatments. These advancements often address unmet medical needs, positioning companies for substantial growth. For instance, according to a report from Statista (2023), global spending on biopharma R&D exceeded $200 billion USD, demonstrating the scale of innovation.
2. Market Growth: According to market reports such as those from Grand View Research, the global biotech market is expected to grow at a compound annual growth rate (CAGR) of 7.4% from 2024 to 2030, reaching a valuation of approximately $3 trillion. This growth is fueled by increased healthcare demands, advancements in technology, and rising investment in research and development.
3. Strategic Partnerships: Many biotech companies form alliances with larger pharmaceutical firms to fund clinical trials, secure distribution channels, and enhance market access. In 2024 alone, over $75 billion USD in partnerships and licensing agreements were reported by Evaluate Pharma, showing the high financial stakes involved.
4. High Return Potential: While biotech stocks can be volatile, successful clinical trials and regulatory approvals often lead to exponential stock price increases. For example, in 2024, biotech firm XYZ saw its valuation grow 300% following positive Phase III trial results, drawing both institutional and individual investors into the space.

https://preview.redd.it/1yhdalzxlxfe1.png?width=831&format=png&auto=webp&s=b8210bd6824e88e2e2255db9ba6771bdeb6d9da6

Success Stories in Biotech Investing

Several biotech companies have delivered remarkable returns for investors over the years. Here are a few notable examples:

• Moderna: Initially known for its research in messenger RNA (mRNA) technology, Moderna’s valuation skyrocketed during the COVID-19 pandemic as it became one of the first companies to develop an effective vaccine. Investors who bought Moderna stock in early 2020 saw returns of over 800% by the end of the year. By late 2021, the company reported over $17 billion USD in vaccine revenue, reflecting its rapid growth. (Source: Financial Times, Moderna earnings reports)
• Amgen: A pioneer in the biotech space, Amgen’s development of groundbreaking biologics for chronic diseases has made it a mainstay for long-term investors. In 2023, Amgen’s total revenue exceeded $26 billion USD, supported by its best-selling drugs like Enbrel and Repatha. Additionally, its annual dividend yield grew consistently, rewarding shareholders. (Source: Amgen annual report 2023)
• BioNTech: Like Moderna, BioNTech gained global recognition for its role in developing an mRNA-based COVID-19 vaccine in partnership with Pfizer. The company’s success story illustrates how innovative partnerships can transform a company into an industry leader almost overnight. In 2021, BioNTech’s revenue surged to $22 billion USD, with stock prices reflecting a 400% gain at their peak compared to pre-pandemic levels. (Source: BioNTech financial disclosures)

Introducing NurExone Biologic: A Promising Innovator in Regenerative Medicine

One of the most exciting developments in the biotech space comes from NurExone Biologic (NRX), a company focused on advanced treatments for central nervous system (CNS) injuries. NurExone’s proprietary platform aims to revolutionize the treatment of spinal cord injuries and other CNS-related conditions through groundbreaking exosome-based therapies.

Recent Achievements and Corporate Milestones

1. Promising Preclinical Results in Vision Restoration*(December 6, 2024)*
   • NurExone Biologic (NRX) announced highly encouraging preclinical results in restoring vision following optic nerve damage. The company’s proprietary ExoPTEN therapy demonstrated a remarkable ability to regenerate damaged optic nerves in animal models. This achievement underscores the versatility of NurExone Biologic (NRX)’s exosome-based treatments and expands their potential applications beyond spinal cord injuries.
2. Third Quarter 2024 Financial Results and Corporate Update (November 27, 2024)
   • NurExone Biologic (NRX) reported steady progress in its research and development pipeline, with continued investment in preclinical and early clinical studies. The company also highlighted its disciplined financial management, ensuring sufficient liquidity to advance key projects.
3. European Medicines Agency (EMA) Orphan Drug Status (November 13, 2024)
   • NurExone Biologic (NRX) secured Orphan Drug Designation from the EMA for ExoPTEN, its exosome-based therapeutic for spinal cord injury. This designation offers several key benefits, including regulatory support, market exclusivity, and reduced fees for clinical trials in the European Union.

Why NurExone Stands Out in the Biotech Sector

NurExone’s innovative approach to CNS injuries distinguishes it from competitors in the biotech space. Here are a few reasons why NurExone is a company to watch:

• Pioneering Exosome-Based Therapy: Exosomes are small vesicles that facilitate intercellular communication and play a crucial role in tissue regeneration. NurExone’s proprietary exosome platform has the potential to offer minimally invasive, highly effective treatments for conditions that currently have limited therapeutic options.
• Regulatory Tailwinds: Achieving Orphan Drug Designation is a significant milestone that underscores the uniqueness of ExoPTEN and provides a competitive edge in regulatory pathways.
• Expanding Clinical Pipeline: While initially focused on spinal cord injuries, NurExone’s technology platform is versatile and could be applied to various CNS-related disorders, increasing its long-term growth potential.

The Future of Biotech Investing

Biotech investments come with risks, particularly due to the high costs and long timelines associated with drug development. However, companies like NurExone Biologic demonstrate that identifying innovative firms with strong clinical pipelines and regulatory backing can yield substantial rewards.

Investors interested in biotech should consider the following strategies:

1. Diversification: Spread investments across multiple biotech companies to mitigate risks associated with clinical setbacks.
2. Long-Term Perspective: Drug development is a lengthy process. Be prepared to hold investments through multiple phases of clinical trials.
3. Stay Informed: Regularly monitor company announcements, regulatory approvals, and industry trends to make data-driven decisions.

NurExone Biologic Inc. (OTCQB: NRXBF) (TSXV: NRX)

Conclusion

The biotech industry’s ability to deliver life-changing treatments makes it a compelling space for investment. Companies like NurExone Biologic exemplify the potential for groundbreaking therapies to disrupt traditional medical paradigms and generate significant returns for investors. By staying informed and identifying key players early, investors can participate in the growth of this innovative and impactful sector.

Am I writing the same surprised post after the quarterly report

(Unfortunately only in Swedish for now)

https://mb.cision.com/Main/6746/4097259/3230831.pdf

Do the investors even read The CEO's words or are they content to read the stereotypical headlines with Dagens Industri as a guiding star?

(Dagens Industri is a Swedish economic magazine (which allowed itself to write a near-insane bad article about top-line Diagnode-2))

Same Dagens Industri with some apostates who proved their ignorance of understanding scientific text in relation to Top-Line completed studies.

Diamyd medical AB (ISIN number SE0005162880) strengthens its position for each quarter they can continue without a partner of any kind.

In the almost non-existent Swedish economic forums is still being discussed only cooperation agreements with Big Pharma where it is assumed that DMYD shall conclude an agreement there in principle all future profit is given away towards up-front and mile-stones far below what we investors invested in the company over the years.

It is natural that DMYD is pursuing its plan to go to market without the BP agreement.

They can easily do that through an RE to hedged funds.

Say that fund with a focus on medicine that cannot value DMYD’s Potential?

What fund does not want a larger share than its competing funds?

In the same way that witch BP does not want to end the contract with DMYD than sedentary see its competitor close the deal?

Tomorrow, Carnegie will raise the justified value on a number of factors.

Quite the drop, as you can see from the chart.

https://preview.redd.it/zbq60irlhsfe1.jpg?width=1013&format=pjpg&auto=webp&s=8c7954ad948feebf1aee1548853da8e3668bd589

Today, LPTX reported initial clinical data from Part B of their DeFianCe trial and Part C of their DisTinGuish study [press release]. The data can also be viewed in their latest corporate presentation [download link].

The DeFianCe Phase 2 study is evaluating sirexatamab (DKN-01) in combination with bevacizumab and chemotherapy as a second-line treatment for patients with advanced colorectal cancer (CRC).

• Data from Part B of the DeFianCe study closely mirror the findings from Part A.
• ITT population (n=188): Patients treated with sirexatamab plus bevacizumab and chemotherapy (Experimental Arm, n=94) had ORR of 35% and DCR of 86%, compared to an ORR of 23% and DCR of 84% in patients treated with bevacizumab and chemotherapy alone (Control Arm, n=94)
• Population with left-sided primary tumors (n=144): Experimental Arm (n=71) had an ORR of 38% vs an ORR of 25% in the Control Arm (n=73).
• Other subgroup analysis:
  • No prior anti-VEGF therapy (n=94): Experimental Arm (n=49) ORR 51% vs Control Arm (n=45) ORR 29%
  • Prior anti-EGFR therapy (n=50): Experimental Arm (n=28) ORR 54% vs Control Arm (n=22) ORR 27%
  • RAS wildtype (RAS-wt) tumors (n=60): Experimental Arm (n=35) ORR 43% vs Control Arm (n=25) ORR 32%
• PFS is not yet mature. Eighty-two patients are still on study, 46 in the Experimental Arm and 36 in the Control Arm. Leap expects to report additional data as it matures in 2025.

The strong signal in CRC from the DeFianCe study supports Leap moving forward to plan a registrational Phase 3 clinical trial to evaluate sirexatamab plus bevacizumab and chemotherapy in second-line MSS CRC patients with high unmet need, subject to regulatory discussions. Potential Phase 3 patient populations include: DKK1 biomarker-selected, anti-VEGF naïve, anti-EGFR experienced, or RAS-wt patients. While the data matures, Leap intends to conduct global commercial and regulatory strategic analysis to select the optimal population.

The Phase 2 DisTinGuish study is evaluating sirexatamab in combination with tislelizumab and chemotherapy in first-line patients with advanced gastroesophageal junction (GEJ) and gastric cancer.

• ORR, ITT population (n=170): Patients treated with sirexatamab plus tislelizumab and chemotherapy (Experimental Arm, n=85) had a confirmed ORR of 52% by both IA and BICR, while patients treated with tislelizumab and chemotherapy alone (Control Arm, n=85) had a confirmed ORR of 56% by IA and 42% by BICR.
• mPFS, ITT population (n=170): Preliminary median PFS in the Experimental Arm was 9.72 months by BICR and 7.66 months by IA vs 11.99 months by BICR and 10.41 months by IA in the Control Arm.

While demonstrating activity in biomarker populations, the study did not generate a clear positive signal and will be negative on the primary PFS endpoints when the study completes, resulting in the decision not to move forward with Phase 3 studies in gastric cancer.

They will not move sirexatamab to a Phase 3 in gastric cancer. For CRC they do plan to move sirexatamab to Phase 3. However they plan to do this in a more limited patient population, with the Phase 3 possibly focusing on DKK1 biomarker-selected, anti-VEGF naïve, anti-EGFR experienced, or RAS-wt patients.

Big drop as a result. LPTX previously reported $62.8 million in cash and cash equivalents at the end of Q3 2024. At the time of their last 10-Q, they said they had enough cash to fund operations for at least the next 12 months from the issuance of their financial statements.

Recommends new investors who don't know biotech well enough to dare to invest to explore AI as an aid to sifting through basic information.

It is still the own know-how that determines whether AI produces useful results or lies like many do about the biotech companies.

Personally, I know very little about AI and how it can be used. Read about one “AI based” search service”. I think the answers I get from that search service should be able to inspire those who don't know biotech or Diamyd medical AB (ISIN number SE0005162880)

.

Maybe I should search further if there is a better AI-based service that can do medical evaluation better? For I probably can read scientific text and render it in understandable form to journalists and investors.

Feel free to give Perplexity AI a test drive (Email address is requested for 3 question). Grateful for feedback if you have better AI help and your experiences on AI for biotech investments)

https://www.perplexity.ai/

Reading about different analysis methods and wondering about biotech plays. Do you guys put more weight on upcoming catalysts or current financials? I'm having mixed results. Any thoughts on this?

I know this company because they worked on a polyclonal influenza antibody, but they have prioritized diabetes type 1. Their concept is based on modified cows with a human immune system. In the context of diabetes type 1 they want to replace the currently used rabbit immunoglobulin with "human" immunoglobulin from cows that should have similar benefits without adverse reactions.

"Using advanced genetic engineering and antibody science to develop Transchromosomic (Tc) Bovine™, the only transgenic animal with a human artificial chromosome, SAB’s DiversitAb™ drug development production system is able to generate a diverse repertoire of specifically targeted, high-potency, human IgGs that can address a wide range of serious unmet needs in human diseases without the need for convalescent plasma or human donors."

https://www.globenewswire.com/news-release/2025/01/23/3014142/0/en/SAB-BIO-Announces-R-D-Webinar-Event-to-Review-Phase-1-Topline-Results-for-SAB-142-a-Disease-Modifying-T1D-Therapy.html

Retail trading phenom Grandmaster-Obi, hailed as the “New-Aged Warren Buffett,” is once again the talk of the stock market. His NVNI alert, which took the market by storm last Friday (1/24/25), continues its explosive rally. As of this morning (1/27/25), NVNI has hit an incredible $6.86, delivering jaw-dropping returns for those who followed Obi’s call.

But this is more than just another winning pick — it’s a resounding testament to why Yahoo Finance has named Grandmaster-Obi the “Most Accurate Stock Market Influencer” of the year.

https://preview.redd.it/pybdi46i7lfe1.png?width=529&format=png&auto=webp&s=b0f82a013c0bfb9b241f69670b42aaca75ecd8fb

Hey guys, I built a system that tracks when stocks are awarded government contracts. It picked up on a contract to Ginko Bioworks last week and the stock surged 40% in a few days.

It looks like the price and corrected downwards and I’m wondering if anyone has any thoughts on the future outlook for this stock? Alerts are sent to discord.gg/contractwatch

I’ve been following r/TNXP and r/pennystocks for a couple of months and it seemed like a great investment/easy money at first. Highly statistical improvements for fibromyalgia in multiple phase 3 clinical trials and a potential FDA approval this summer, sounds perfect right? Yet TNXP is a pennystock and its market cap is below 100M. What’s going on?

Ok, let’s look at the data of the three last phase 3 clinical trials of TNX-102 SL for fibromyalgia (NCT05273749, NCT04172831, NCT04508621, clinicaltrials.gov, use “Results Posted” tab). These three studies are randomized, double-blind and placebo-controlled and patients were tested for pain, overall improvement, sleep quality and fatique. Compared to placebo, receiving TNX-102 SL showed statistically significant improvements, strongly suggesting that the drug works!

However, there is a possible explanation which could explain these potentially great results:

-Symptoms of the treated and the placebo groups both improve nicely, the treated groups just improved more. That both groups are doing better can be explained by symptoms improving naturally over time or the placebo effect. The placebo effect is especially problematic when subjective improvements are measured (questionaries for pain/sleep) versus objective measurements (e.g., a quantification of a certain blood marker, but unfortunately fibromyalgia has no objective markers). In short, knowing that one receives a “real” drug often improves symptoms.

-How would a patient know whether they got TNX-102 or a placebo? The studies are double blinded, so both the patients and the doctors don’t know who gets the drug or placebo. However, in cases of drug-induced side effects they could know. A certain drug giving noticeable side effects makes the patient believe they are getting the real drug and there is a stronger placebo effect.  Unfortunately, TNX-102 has significant non-serious side effects; around 30% of patients have TNX-102-specific side effects such as numbness/tingling in their mouths.

This indicates that TNX-102 may not work at all, and it’s all based on the placebo effect. This would also explain the low stock price; large investors would pick up on this easily but individual investors won’t.

The placebo effect could be easily analyzed by Tonix by excluding the 30% of patients with side effects and testing whether the differences between groups remain. I’m 100% sure they have done this already…

A few disclaimers: I think TNX-102 doesn’t work and the stock will tank, but I can be completely wrong of course. I have a PhD in molecular science and work in drug discovery not related to fibromyalgia. I’m seriously worried that people will lose a lot of money this summer, so please be careful.

Hey guys, if you missed it, the US government has filed an investigation against CVS for filling illegal opioid prescriptions for the last 10 years. The company denied any wrongdoing and is cooperating with investigators. but we’ll see how that ends for them. 

About the settlement, Oak Street is accepting late claims for the $60M investor settlement over the free rides scandal. Before being acquired by CVS Health, Oak Street came under fire for offering free rides to federal beneficiaries and engaging in “risky marketing practices.” 

When news of an investigation broke, $OSH shares dropped, and investors filed a lawsuit against the company. But now, Oak Street has already agreed to settle with investors for $60M, and they’re accepting late claims, so if you were impacted back then, you can check the details and file for it.

Now, CVS is being accused of “contributing to a nationwide epidemic of opioid addiction and overdose”. So, we’ll probably have more news in the coming months over this scandal.  

Anyways, did you already know about these OSH services? And has anyone here had $OSH back then? If so, how much were your losses?