Soleno Therapeutics Secures FDA Approval for VYKAT XR: A Groundbreaking Moment for Prader-Willi Syndrome Treatment – $SLNO $IBB $XBI

In a move that has sent shockwaves of excitement through the biotech community, Soleno Therapeutics (NASDAQ: SLNO, Up approx. +40% on Thursday) has successfully secured FDA approval for VYKAT XR, the first-ever treatment for hyperphagia in Prader-Willi syndrome (PWS). This rare genetic disorder, affecting approximately 1 in 15,000 births, is characterized by an insatiable hunger that can lead to a myriad of physical, cognitive, and behavioral challenges25. The approval marks a significant milestone not only for Soleno but also for the PWS community, which has long awaited a therapeutic solution to this debilitating condition.

The Drug: VYKAT XR

VYKAT XR, an extended-release tablet, is designed to combat the intense hunger associated with PWS. The drug’s efficacy was demonstrated through a Phase 3 randomized withdrawal study, where patients who discontinued treatment experienced a significant worsening of hyperphagia compared to those who continued on VYKAT XR56. This robust clinical evidence, coupled with a well-characterized safety profile over four years, solidified the FDA’s decision to grant approval5. VYKAT XR is indicated for the treatment of hyperphagia in adults and pediatric patients 4 years of age and older with Prader-Willi syndrome (PWS).

Market Opportunity

The rare disease treatment market is booming, with projections indicating a growth from $190.11 billion in 2024 to $215.2 billion in 2025, driven by factors such as orphan drug legislation and biotechnological innovations3. By 2037, this market is expected to reach $652.9 billion, expanding at a CAGR of 9.3%7. Soleno Therapeutics is poised to capitalize on this trend with VYKAT XR, which is priced at approximately $466,000 annually for patients, reflecting a favorable pricing strategy that exceeded analyst expectations14. Prader-Willi syndrome (PWS) is a rare genetic neurodevelopmental disorder caused by an abnormality in the gene expression on chromosome 15. The Prader-Willi Syndrome Association USA estimates that PWS occurs in one in every 15,000 live births. The defining symptom of PWS is hyperphagia, a chronic and life-threatening condition characterized by an intense persistent sensation of hunger accompanied by food preoccupations, an extreme drive to consume food, food-related behavior problems, and a lack of normal satiety, which can severely diminish the quality of life for individuals with PWS and their families. Hyperphagia can lead to significant mortality (e.g., stomach rupture, choking, accidental death due to food seeking behavior) and longer term, co-morbidities such as diabetes, obesity, and cardiovascular disease.

Analyst Reactions and Stock Performance

Following the FDA approval, Soleno’s stock experienced a remarkable surge, rising by 40% to reach $68.92, surpassing a key buy point of $60.924. Analysts from Stifel maintained a “Buy” rating with a price target of $74, while others like Oppenheimer and Cantor Fitzgerald raised their targets significantly, highlighting the drug’s potential for peak sales of up to $2 billion in the U.S.1. This optimism is fueled by VYKAT XR’s unique market positioning and the significant unmet need in PWS treatment.

Commercial Strategy

Soleno Therapeutics is well-prepared for the commercial launch of VYKAT XR, scheduled for April 2025. The company has established a comprehensive patient support program, Soleno One, to ensure access to this critical therapy for those affected by PWS5. This strategic approach underscores Soleno’s commitment to addressing the complex reimbursement landscape typical of rare disease treatments.

Beacon Of Hope

The approval of VYKAT XR is not just a victory for Soleno Therapeutics; it represents a beacon of hope for the PWS community. As the biotech sector continues to evolve, Soleno’s success story serves as a testament to the power of innovation in addressing some of humanity’s most pressing health challenges. With its stock on the rise and a promising market ahead, Soleno is certainly a company to watch in the coming years. And who knows? Maybe this approval will be the catalyst that finally lets families affected by PWS enjoy a meal without the constant worry of hyperphagia—a small victory that could be the start of something much bigger.

Citations:

by John F. Heerdink, Jr. March 27, 2025

Indaptus Reports Recent Results/2025 Goals & Expansion With Combination of Decoy20 with BeiGene’s PD-1 Checkpoint Inhibitor – $INDP $ONC

Indaptus Therapeutics (NASDAQ: INDP) , a clinical-stage biotechnology company, has reported its financial results for the fourth quarter and fiscal year 2024, highlighting progress in its Phase 1 trial of Decoy20 and outlining strategic goals for 2025. According to recent updates, the company’s stock has surged, and new data demonstrates successful broad immune system activation in weekly dosing trials of its lead candidate.

Indaptus Q4 Financial Results

For the fourth quarter of 2024, Indaptus reported increased research and development expenses of $2.5 million, up from $2.0 million in Q4 2023, driven by higher costs associated with the Decoy20 Phase 1 clinical trial1. General and administrative expenses decreased to $1.7 million from $2.2 million in the same period last year, reflecting lower legal fees and administrative costs. The company’s cash position as of December 31, 2024, stood at $5.8 million, compared to $13.4 million at the end of 20231. To bolster its financial position, Indaptus secured additional funding through a $2.0 million private placement and established a $20 million equity line of credit with Yorkville in early 2025.

Decoy20 Clinical Progress

Significant strides were made in the Phase 1 trial of Decoy20, with over 20 patients enrolled in the weekly dosing cohort. Early data revealed promising results, including stable disease in some patients and favorable pharmacodynamic immune activation biomarkers1. The drug demonstrated a promising safety profile and potential efficacy as both a monotherapy and combination therapy2.

On March 18, building on these positive outcomes, Indaptus announced that it has advanced to a new expansion arm of its Phase 1b/2 clinical trial of Decoy20. This expansion will evaluate the combination of Decoy20 with BeiGene’s (NASDAQGS: ONC) PD-1 checkpoint inhibitor, tislelizumab, with a focus on safety, dose optimization, and early signs of anti-tumor activity.

Jeffrey Meckler, CEO, Indaptus Therapuetics, Inc. (NASDAQ: INDP)

Jeffrey Meckler, CEO of Indaptus, commented, “This marks a pivotal step forward for Indaptus and our Decoy platform. Preclinical research has consistently shown that Decoy20 works synergistically with a checkpoint inhibitor, and we now have the opportunity to test that in patients for the first time. While this initial phase will focus on safety and tolerability, we are laying the groundwork for what could be a game-changing approach to treating solid tumors. This combination trial is not just a milestone – it’s an opportunity to showcase our platform’s versatility and move one step closer to improving patient outcomes.” Indpatus further highlighted the following:

Initial participants will first receive one week of Decoy20 monotherapy intravenously before starting the combination treatment with Decoy20 + tislelizumab.
The first few patients in the combination phase will be enrolled sequentially to monitor safety.
After review by the trial’s Safety Review Committee, unrestricted enrollment will begin.
Participants will receive both treatments for up to one year, or until disease progression, unacceptable toxicity, or withdrawal from the study.

Checkpoint inhibitors such as tislelizumab have improved outcomes in a variety of cancers but many patients still do not respond or ultimately do not experience a long-lasting effect. Decoy20 is engineered to activate the immune system in a manner that is theorized to significantly enhance and broaden the effectiveness of checkpoint inhibitors.

PD-1 inhibitors work by blocking the PD-1 (programmed death-1) receptor on T cells, preventing cancer cells from evading the immune system and restoring the body’s ability to fight cancer. Combining checkpoint inhibitors with immune system activators like Decoy20 could provide a more powerful and sustained anti-tumor response.

The Indaptus Approach

Indaptus is committed to advancing innovative therapies that harness the immune system to fight cancer. With the launch of this combination trial, the Company is taking a major step towards realizing the full potential of its Decoy platform. Their platform is based on the hypothesis that highly efficient anti-tumor immunotherapy will require safe activation of both innate and adaptive cellular immunity in both tumors and immune organs, and that this might be achieved with a multi-targeted package of bacterial PAMPs, in the form of attenuated and killed, intact but non-pathogenic bacteria delivered intravenously. While current therapies are increasingly becoming more and more personalized and costly, they are advancing an approach designed to be widely accessible, with broad anti-tumor and anti-viral activity not dependent on the targeting of specific tumor or viral antigens. Furthermore, generation and/or activation of the cells required for innate and adaptive anti-tumor and anti-viral immune responses takes place, to a significant extent, outside of the tumor or sites of infection, including in the spleen. Indataptus’ intravenous therapeutic candidates are expected to passively target the liver, spleen, and leaky vasculature of tumors, producing immune activation in an immune organ, as well as a common site for primary and metastatic cancer and HBV infection, the liver. As their therapeutic candidates are expected to be cleared very quickly by the liver and spleen, they anticipate a low risk of non-specific autoimmune side effects relative to other types of immunotherapies designed for continuous exposure.

Strategic Goals for 2025

Focusing on future growth and clinical advancement, Indaptus has outlined key objectives for 2025. The company plans to expand clinical trial sites to accelerate patient enrollment, aiming to provide regular updates on weekly dosing cohorts and initiate combination studies1. Additionally, Indaptus intends to nominate a new candidate for IND-enabling studies based on the expansion of their Decoy platform technology2. These strategic goals underscore the company’s commitment to advancing innovative immunotherapy approaches while maintaining financial discipline to support its ambitious growth trajectory.

CMO360 Summit April 7-8 Boston

Indaptus’ chief medical officer, Roger Waltzman, M.D., M.B.A. will be moderating a panel at the annual CMO360 Summit, being held April 7-8 in Boston. Dr. Waltzman’s panel, titled “Ensuring Effective and Efficient Trials Through Clinical Operations” will be Monday, April 7^th from 4:05PM – 4:35PM ET. Jeffrey Meckler, Indaptus CEO, commented, “These opportunities serve as continued validation for our approach to clinical trial management, reinforcing its potential to enhance efficiency, an essential factor in our industry. We appreciate this esteemed conference’s recognition and look forward to Roger’s panel, anticipating valuable insights from the discussion.”

The CMO Summit 360° ®, operated by The Conference Forum, is the largest gathering of biotech Chief Medical Officers across indications, modalities, company stages, professional experience levels and geographic locations. This is the conference to connect with peers and develop the skills needed to succeed as a biotech CMO. The Conference Forum is a life science industry research, conference development and marketing firm. The company brings the full spectrum of executives together to share ideas and information on how to advance efficient medicine development and delivery, patient diversity and access.

by John F. Heerdink, Jr. March 26, 2025

Dollar Tree Decides to Let Go of Family Dollar: A Billion-Dollar Breakup – $DLTR $SPY

Dollar Tree Decides to Let Go of Family Dollar: A Billion-Dollar Breakup

In a move that’s been brewing for a while, Dollar Tree has announced it’s selling off its Family Dollar business to Brigade Capital Management and Macellum Capital Management for a cool $1.007 billion. This deal marks the end of a long review process aimed at finding the best way to unlock value for Dollar Tree shareholders and give Family Dollar the freedom to flourish on its own.

Why the Split?

Dollar Tree’s leadership believes this sale is a crucial step in their multi-year transformation plan, allowing them to focus more intently on growing their core business. With plans to expand their product range and open new stores across the U.S., Dollar Tree is positioning itself for significant growth. Meanwhile, Family Dollar will remain headquartered in Chesapeake, Virginia, and will continue to offer affordable goods to communities nationwide.

New Chapter for Family Dollar

Under the guidance of President Jason Nordin and with the financial backing of Brigade and Macellum, Family Dollar is poised for a fresh start. The company will benefit from the expertise of Duncan MacNaughton, who is joining as Chairman. MacNaughton’s experience as a former President and Chief Operating Officer of Family Dollar will undoubtedly be invaluable in driving the business forward.

The Investors’ Perspective

Brigade Capital Management and Macellum Capital Management see immense potential in Family Dollar. Brigade’s Matt Perkal highlighted Family Dollar’s role as a community pillar, offering quality products at great value. Macellum’s CEO, Jonathan Duskin, expressed excitement about reinvigorating this iconic brand, noting the exceptional team and strategic plan in place.

The Deal Details

The transaction is expected to close in the second quarter of 2025, pending regulatory approvals. J.P. Morgan Securities LLC and Davis Polk & Wardwell LLP are advising Dollar Tree, while Jefferies LLC and RBC Capital Markets are leading the financial advisory team for Brigade and Macellum. Financing for the deal is being provided by Wells Fargo, RBC Capital Markets, and WhiteHawk Capital Partners.

In summary, this billion-dollar breakup could be just what both parties need to thrive. Dollar Tree gets to focus on its core business, while Family Dollar gets a new lease on life with fresh investors and leadership. It’s a win-win, and we can’t wait to see how these two retail giants evolve in the coming years.

Citations:

https://corporate.dollartree.com/news-media/press-releases/detail/280/dollar-tree-announces-agreement-to-divest-its-family-dollar

by John F. Heerdink, Jr. March 11, 2025

Discover GeoVax’s Innovative Technologies For MPOX, Cancers & Beyond – ( $GOVX $IBB $XBI )

GeoVax Labs, Inc. (NASDAQ: GOVX), a clinical-stage biotechnology company, is developing innovative vaccines and immunotherapies against infectious diseases and cancers using proprietary platforms, with six ongoing clinical trials and a pipeline of preclinical programs targeting significant unmet medical needs.

GeoVax’s Innovative Technologies

At the forefront of GeoVax’s innovative approach are two major technologies: the Modified Vaccinia Ankara (MVA) platform and Gedeptin. The MVA platform serves as the foundation for developing vaccines against various infectious diseases, including the next-generation COVID-19 vaccine GEO-CM04S1, currently in multiple Phase 2 clinical trials. Gedeptin, a novel oncolytic solid tumor gene-directed therapy, has completed a Phase 1/2 trial for advanced head and neck cancers and is being further developed for other solid tumor indications. These cutting-edge technologies position GeoVax to address critical unmet medical needs and potentially revolutionize vaccine and immunotherapy development.

Clinical Trials and Pipeline

GeoVax’s robust pipeline includes six ongoing clinical trials, with numerous preclinical programs in development. The company’s lead candidate, GEO-CM04S1, is being evaluated in three Phase 2 trials for COVID-19, targeting immunocompromised patients, those with chronic lymphocytic leukemia, and as a durable booster for healthy individuals previously vaccinated with mRNA vaccines. Additionally, GeoVax is advancing preclinical programs for preventive vaccines against Mpox, smallpox, hemorrhagic fever viruses (Ebola Zaire, Ebola Sudan, and Marburg), malaria, and Zika virus. This diverse portfolio demonstrates GeoVax’s commitment to addressing a wide range of infectious diseases and cancers, positioning the company as a potential leader in vaccine and immunotherapy development.

Vaccine Market Growth Potential

The global vaccine market is poised for substantial growth, with Data Bridge Market Research projecting a compound annual growth rate (CAGR) of 10.7% between 2024 and 2031, potentially reaching a market size exceeding $168 billion. This robust expansion presents a significant opportunity for innovative companies like GeoVax Labs, Inc., even if they capture only a modest share of the market. The company’s diverse pipeline, addressing both infectious diseases and cancers, positions it to potentially capitalize on multiple segments within this rapidly growing industry.

Key Milestones Achieved In The past year

Over the past year, GeoVax Labs, Inc. has achieved several key milestones that highlight its progress in vaccine and immunotherapy development:

:
- GeoVax received a significant award from the Biomedical Advanced Research and Development Authority (BARDA) to advance its next-generation COVID-19 vaccine, GEO-CM04S1, into a large-scale Phase 2b clinical trial. This trial will compare GEO-CM04S1 to an authorized mRNA vaccine in a 10,000-participant study2 34.
:
- Gedeptin, an oncolytic solid tumor gene-directed therapy, completed a Phase 1/2 trial for advanced head and neck cancers. Plans are underway to initiate a Phase 2 trial in the first half of 2025, focusing on first recurrent head and neck cancer, in combination with an immune checkpoint inhibitor.
:
- GeoVax made significant progress with GEO-MVA, aiming to become the first U.S.-based source for a Mpox vaccine. The company successfully manufactured a cGMP Master Seed Virus and is on track to produce a clinical batch by the end of 2024.
:
- GeoVax achieved a milestone in transitioning to a commercially validated manufacturing system for its MVA-based vaccines, including the production of GEO-CM04S1 using a commercial platform.
:
- GeoVax strengthened its cash position and secured additional funding, enabling further development of its pipeline programs. The company reported increased revenues and is poised for significant progress in 2025 with multiple catalyst-rich milestones

These achievements underscore GeoVax’s commitment to addressing critical unmet medical needs and its strategic positioning within the rapidly evolving vaccine and immunotherapy landscape.

Opportunities with GeoVax

Investors seeking growth opportunities in the biotechnology sector may find GeoVax Labs, Inc. (GOVX) an intriguing prospect. The company’s stock has demonstrated significant volatility, with two major rallies in recent months culminating in a high of $11.18 in August, according to Thinkorswim data. These price movements, including instances of over 500% gains, highlight the potential for substantial returns. However, it’s crucial to note that such volatility also carries inherent risks. The company’s progress through FDA clinical trials presents potential catalysts for stock appreciation, with each milestone potentially igniting investor excitement. As GeoVax advances its pipeline of vaccines and immunotherapies, particularly in the rapidly growing vaccine market, it offers a unique investment opportunity for those willing to navigate the risks associated with clinical-stage biotechnology companies.

Learn More

Just last week, GeoVax Chairman & CEO, David Dodd presented at Tribe Public’s CEO Presentation and Q&A Webinar Event titled “MPOX 2025: Navigating the Global Public Health Emergency.” The presentation covered a number of topics that included the following:

Mpox remains a global public health crisis in 2025, with Clade 1b exhibiting higher transmissibility and severity than Clade 2.
The Democratic Republic of the Congo (DRC) is the epicenter, with over 60,000 suspected cases and 1,300 deaths in 2024 alone.
The virus has now spread to multiple countries, including the U.S., Canada, and Europe, raising concerns about global containment.
The U.S. has confirmed four Clade 1b cases (California, Georgia, New Hampshire, and New York), prompting the need for urgent action.
The current vaccine supply chain is inadequate, relying heavily on a single non-U.S. manufacturer.
Delays in vaccine distribution, high costs, and limited production capacity have exacerbated the crisis, particularly in Africa, where vaccine stockpiles remain largely unused due to logistical and political challenges.
GEO-MVA, the GeoVax Mpox vaccine candidate is advancing to clinical evaluation, anticipated for H2 ’25.

Citations:

by John F. Heerdink, Jr. March 6, 2025

Jazz Pharmaceuticals’ Chimerix Acquisition Marks Significant Milestone In Precision Neuro-Oncology – ( $JAZZ $CMRX $LTRN )

Jazz Pharmaceuticals’ (NASDAQ: JAZZ) $935 million acquisition of Chimerix (NASDAQ: CMRX) marks a significant milestone in precision neuro-oncology, highlighting the growing potential of targeted therapies for brain cancers and signaling a shift towards biomarker-driven approaches in treating central nervous system tumors. The $935 million acquisition includes dordaviprone, a novel small molecule therapy targeting H3 K27M-mutant diffuse glioma in children and young adults. This rare pediatric brain tumor affects approximately 2,000-2,200 U.S. patients annually, representing 7-10% of brain cancers. Jazz will purchase Chimerix shares at $8.55 each, a 72% premium over the last closing price on March 4, 2025. The deal is expected to close in the second quarter of 2025, with FDA approval for dordaviprone anticipated in August 2025. Jazz has indicated a potential treatment cost of $300,000-$500,000 per patient, positioning dordaviprone as a significant addition to their oncology portfolio.

Precision Neuro-Oncology Advances

Recent advancements in precision neuro-oncology have led to a paradigm shift in treating central nervous system (CNS) tumors. Researchers are increasingly focusing on patient-derived models and functional precision medicine to evaluate therapeutic efficacy by directly treating living patient tumors ex vivo, potentially improving treatment selection and patient outcomes. This approach, combined with artificial intelligence applications in diagnosis, prognosis, and precision treatment, is transforming the landscape of neuro-oncology.

Gene therapy techniques, such as CAR-T cell therapy, show promise in extending survival for patients with aggressive brain tumors like glioblastoma.
Innovative immunotherapy approaches, including bi-specific antibodies and protein degraders, are emerging as potential game-changers in solid tumor treatment.
The integration of AI-driven technologies is enhancing the understanding of tumor microenvironments and potentially identifying new predictive biomarkers.

STAR-001 vs. Dordaviprone

STAR-001, Lantern Pharma’s (NASDAQ; LTRN) precision oncology candidate developed by its subsidiary Starlight Therapeutics, offers several potential advantages over dordaviprone in the neuro-oncology market. With a target population of 60-70% of glioblastoma multiforme (GBM) cases, STAR-001 addresses a significantly larger patient group of 12,000-15,000 U.S. patients annually, compared to dordaviprone’s 2,000-2,200 patients. This broader reach translates to an estimated $3.4 billion addressable market in the U.S. alone, assuming a $250,000 per treatment cost.

Key differentiators for STAR-001 include:

Biomarker-driven activation by PTGR1, an enzyme overexpressed in many GBM cells
Potential efficacy in brain metastases from other cancers, expanding the addressable market
Synergistic effects when combined with spironolactone, potentially enhancing efficacy and safety
Multiple Rare Pediatric Disease Designations, which could yield valuable Priority Review Vouchers
Ongoing development for additional indications, including a Fast Track Designation for triple-negative breast cancer treatment

Future Neuro-Oncology Trends

Emerging trends in neuro-oncology for 2025 include advancements in precision medicine, immunotherapy, and artificial intelligence applications. Bi-specific antibodies are expected to lead an immuno-oncology renaissance in solid tumors, while synthetic lethality approaches gain traction for targeted cancer therapies. AI-driven technologies are enhancing diagnosis, prognosis, and treatment precision, potentially revolutionizing patient care.

Novel treatment modalities, such as CAR-T cell therapy and gene therapy, show promise for brain tumors.
Addressing cancer disparities and improving access to cutting-edge treatments remain key focus areas.
The integration of patient-derived models and functional precision medicine is expected to improve treatment selection and patient outcomes.

Last Idea Of The Day

An idea would be for investors to look further into companies that have precision, neuro-oncology assets, and that are actively managing them to successful milestones for example companies like Lantern Pharma’s (NASDAQ; LTRN) and also Starlight Therapeutics.

by John F. Heerdink, Jr. February 24, 2025

Apple Decides To Make It Rain On The US Economy With $500B Commitment – ( $AAPL $NVDA $DIA $SPY $QQQ )

In a move that would make even Scrooge McDuck’s vault look like a piggy bank, Apple has decided to make it rain on the US economy, announcing a jaw-dropping $500 billion investment over the next four years. This financial thunderstorm comes with a silver lining of 20,000 new jobs, proving that the tech giant is determined to keep America’s innovation engine purring like a well-oiled Mac.

The Orchard of Opportunity

Apple’s grand plan includes planting a seed in the Lone Star State, with a new 250,000 square-foot manufacturing facility set to sprout in Houston by 2026. This digital greenhouse will cultivate servers to power Apple’s AI services, ensuring that Siri can continue to misunderstand our requests with ever-increasing sophistication.

But wait, there’s more! The company is also establishing an educational academy in Michigan, focusing on manufacturing. One can only hope that “How to Survive Your iPhone Falling from a 20-story Building 101” will be part of the curriculum.

The Core of the Matter

Tim Cook, Apple’s CEO and chief apple polisher, waxed poetic about the investment: “We’re bullish on the future of American innovation, and we’re proud to build on our long-standing U.S. investments with this $500 billion commitment to our country’s future”5. One can’t help but wonder if this bullishness is related to the recent meeting with President Trump, who has been threatening to slap tariffs on Chinese imports faster than you can say “trade war”.

A Fruitful Future?

While Apple’s announcement is certainly impressive, it’s worth noting that this isn’t their first rodeo. In 2021, they pledged $430 billion over five years, and back in 2018, they promised $350 billion over five years. At this rate, by 2030, Apple might just buy the entire country and rename it “iMerica.”

As we marvel at these astronomical figures, let’s not forget that Apple still produces most of its products in China.Perhaps this investment is less about patriotism and more about avoiding those pesky tariffs. After all, nothing says “I love America” quite like strategically avoiding taxes.

In conclusion, whether you’re an Apple fanboy or a Windows warrior, there’s no denying that this investment is a big deal. Just remember, the next time you’re struggling to afford the latest iPhone, you can console yourself with the knowledge that your financial pain is contributing to America’s “extraordinary new chapter in the history of innovation”. Now, if you’ll excuse me, I need to go sell a kidney to pre-order the iPhone 20.

Citations:

More in TECH….!

Pebble’s Announces Participation in the Nvidia Developer Ecosystem to deliver Pebble-falcon Energy Aware Cloud Solution

Artificial Intelligence is rapidly transforming how we use technology not just in our daily lives but also to address some of the world’s biggest challenges, from healthcare to climate change. NVIDIA is laying the foundation of the AI revolution and their GPU chips are the workhorse for training AI models. As models continue to become more capable and bigger in parameter size, it comes at the cost of rising electricity consumption and energy demands. While the energy used by AI systems can vary depending on the task complexity, they generally require significant amounts of energy. Early applications were estimated to require about ten times the electricity—from 0.3 watt-hours for a traditional Google search to 2.9 watt-hours for a Chat- GPT query—to respond to user queries.

The compute and energy required for AI can be divided into two parts, training compute and inference. Energy consumption for training is dependent on the Data Center design, the energy mix at the location, GPU hardware used, Neural network architecture like transformers, # of epochs / training runs, parameters and size of the dataset. Whereas inference compute is when the model is deployed on cloud environments for prompting and general use. With the most recent advances in reasoning, Agentic AI systems where a bunch of models are coordinating together, test time scaling and the compute required at inference time is going to go “through the roof”.

Data Center and its rising energy demands

Behind all the AI boom is a massive network of Data Centers Infrastructure. Investment in Data Centers around the world and in the United States continues to soar. In 2023, overall capital investment by Google, Microsoft and Amazon, which are industry leaders in AI adoption and data center installation, was higher than that of the entire US oil and gas industry – totalling around 0.5% of US GDP. (3) At the CES, Arm recently estimated that the US Data centers would increase 13x, from 1.5% 2021 of the US energy footprint to over 20% by 2030.

Energy aware computing using pebble-falcon

Leveraging the GPU efficiency and the recently announced Nvidia Blueprint ecosystem, Pebble-Falcon is positioned to take advantage of the massive opportunity in tracking and reducing the carbon and water footprint of workloads running on Cloud and Data Centers. Pebble-FalconTM is a purpose built Energy management solution to deliver the industry’s first multi factored sustainability cloud solution that uses agentic AI to maximize performance, energy efficiency, security, redundancy, carbon and water reduction for workloads running on cloud environments. While cloud providers like AWS , GCP both offer carbon monitoring and intelligent tools to reduce energy usage and use carbon-free energy as much as possible, our objective is to offer a differentiated view by offering energy efficient optimization in a single pane of glass for single or hybrid / multi-cloud environments at the application level in near real time.

Optimizing for AI models for Energy Efficiency

For AI models, we measure the carbon footprint for training, if the information around GPUs, Data Center is available and inference. We can gather information on what cloud region it is running on and using Electricity mix determine the energy mix and carbon intensity to calculate the carbon footprint of serving these models.

Not all tasks require the best and the largest model to achieve results. The compute requirement to solve a tough math problem would be vastly different than answering a simple factual question like what is the capital of France? The spread in energy efficiency varies significantly depending on the model used for each of the text generation, image classification, and summarization tasks, as research suggests . We’d have access to the user prompt, model response, model parameters, gpu, cloud metrics, host, device (edge) and can offer recommendations on what model, host, gpu, device (edge) would be the most appropriate and energy efficient. The energy efficiency ratings of the model is available on HF: AI Energy Score Leaderboard.

NVIDIA Developer Program

At pebble, we are integrated in the NVIDIA AI Developer Ecosystem as we build out our set of tools for energy management. For any fine-tuning and model training needs, we plan to employ NEMO framework and leverage. And in order to deploy the models efficiently, we employ NVIDIA NIM (NVIDIA Inference Microservices), which allows us to run AI models on NVIDIA GPUs on AWS managed services like EKS, SageMaker and on edge devices. We are excited about NVIDIA’s Agentic framework Blueprint as we go from prototyping Agents to deploying them in production environments.

In closing, Pebble-FalconTM empowers organizations to significantly reduce the energy consumption of their AI workloads, enabling a more sustainable approach to cloud computing. This leads to both cost savings and a measurable reduction in the carbon footprint of AI-driven operations.

1 https://www.epri.com/research/products/3002028905

2 https://www.forbes.com/sites/johnwerner/2025/01/09/jensen-huang-at-ces-agentic-ai-big-hardware-and-more/

3 https://www.iea.org/commentaries/what-the-data-centre-and-ai-boom-could-mean-for-the-energy-sector

4 https://docs.aws.amazon.com/awsaccountbilling/latest/aboutv2/ccft-estimation.html

5 https://blog.google/outreach-initiatives/sustainability/carbon-aware-computing-location/

6 https://cloud.google.com/sustainability/region-carbon

7 https://www.nature.com/articles/d41586-024-02680-3

https://huggingface.co/spaces/AIEnergyScore/2024_Leaderboard

by John F. Heerdink, Jr. February 20, 2025

NVIDIA-Backed Together AI Nets $305M & Has Pirouetted Its Way To A $3.3B Valuation – $NVDA $CRM

In a dazzling display of financial acrobatics, NVIDIA (NVDA) backed Together AI has pirouetted its way to a $3.3 billion valuation, leaving spectators in awe and competitors green with envy. This AI virtuoso, known for its cloud-based wizardry and the enigmatically named RedPajama-V2 dataset, has charmed investors faster than you can say “neural network”.

Imagine, if you will, a world where 45,000 developers are feverishly tapping away at keyboards, conjuring open-source generative AI models with the fervor of caffeinated wizards. That’s the reality Together AI has crafted, much like a digital Hogwarts for the coding elite. Their home page reads: “The AI Acceleration Cloud – Train, fine-tune, and run inference on AI models blazing fast, at low cost, and at production scale.”

But wait, there’s more! The company’s latest funding round, a Series C led by Salesforce Ventures, saw $106 million materialize as if summoned by a particularly lucrative “Accio” spell. One can almost picture CEO Vipul Ved Prakash, donning a metaphorical sorting hat, seemingly declaring, “To Unicorn status and beyond!” According to Reuters today, the company has stated it has raised $305 million in its latest funding round.

This valuation puts Together AI in the same league as mythical creatures and tech darlings alike. It’s as if the company has discovered the AI equivalent of the Philosopher’s Stone, transmuting lines of code into gold-plated server racks.

With services ranging from inference to fine-tuning, and GPU clusters that would make even the most hardened gamer weep with joy, Together AI is positioning itself as the Swiss Army knife of the AI world. It’s like they’ve taken the concept of “one-stop-shop” and applied it to the realm of artificial intelligence, creating a veritable AI supermarket where you can pick up a neural network as easily as a carton of milk.

As we witness this AI acceleration cloud reaching stratospheric heights, one can’t help but wonder: Will Together AI’s next trick involve teaching machines to write Shakespearean sonnets or perhaps decode the mysteries of the universe? Only time will tell, but one thing’s for certain – in the grand theater of tech valuations, Together AI has just delivered a show-stopping performance.

Citations:

by John F. Heerdink, Jr. February 19, 2025

Summary of 5 Top US Stock Performers and Relevant News For Wednesday, Feb. 19 – $COMP $HIMS $FRSH $GE $NVMI

On February 19, 2025, several stocks demonstrated remarkable performance, with Compass, Inc. (COMP) and Hims & Hers Health, Inc. (HIMS) leading the pack. Here’s a summary of the top performers and relevant news:

Compass, Inc. (COMP) surged 28.32% to $10.24. The company released its Q4 and full-year 2024 results on February 18, reporting a 25.9% year-over-year revenue growth and increased market share. Analysts responded positively, with Oppenheimer raising the price target from $9.50 to $12
Hims & Hers Health, Inc. (HIMS) gained 17.50%, closing at $68.74. The stock’s performance was likely influenced by strong Q4 2024 results, including a 35% year-over-year revenue growth and record new subscriber additions5.
Freshworks Inc. (FRSH) was highlighted as a momentum stock to watch, with the Zacks Consensus Estimate for its current year earnings increasing 6% over the last 60 days.
Nova Ltd. (NVMI) was also mentioned as a strong buy, with its current year earnings estimate increasing 5.3% over the last 60 days.
GE Aerospace (GE) was added to the Zacks Rank #1 (Strong Buy) list, with its current year earnings estimate increasing 3.9% over the last 60 days.

These stocks demonstrated significant momentum, with most experiencing higher-than-average trading volumes. The technology, healthcare, and aerospace sectors were well-represented among the day’s top performers.

by John F. Heerdink, Jr. February 11, 2025

A Beacon of Hope Has Emerged For Leukemia Patients From The Labs of IN8bio, Inc. (NASDAQ: INAB)

In the realm of cutting-edge cancer therapeutics, a beacon of hope has emerged from the laboratories of IN8bio, Inc. (NASDAQ: INAB). This clinical-stage biopharmaceutical company has recently unveiled promising results from its ongoing Phase 1 clinical trial of INB-100, a groundbreaking allogeneic gamma-delta T cell therapy. The trial, focusing on patients with leukemia undergoing haploidentical hematopoietic stem cell transplantation (HSCT), has demonstrated not only safety but also remarkable efficacy.

INB-100 Trial Results

The INB-100 trial has enrolled 23 patients, with 16 completing the treatment regimen and of the 16 at the one year mark, 94% remained in remission. Comparatively, data from the University of Kansas demonstrated a 41% relapse rate and a 31% mortality rate across all leukemia patients at one year. Importantly, IN8bio’s INB-100 has had no relapses in AML patients after median follow up at 20.1 months. The results have been remarkably encouraging, with all treated patients achieving complete remission and showing no signs of acute Graft versus Host Disease (aGvHD) grade 3 or higher. With a median follow-up of 21 months, seven out of eight treated patients remain in complete remission, showcasing the potential durability of the therapy’s effect. These promising outcomes have set the stage for IN8bio to present updated results at the 2025 Tandem Meetings, Transplantation & Cellular Therapy Meetings of ACST and CIBTR, hosted in Honolulu, HI. Meeting, where the biotech world eagerly awaits further insights into this innovative approach to leukemia treatment. We look forward to further updates later this year.

Gamma-Delta T Cell Mechanism

Gamma-delta T cells, often likened to a “Swiss Army knife” of the immune system, form the cornerstone of INB-100’s innovative approach. These unique lymphocytes possess an innate ability to recognize and eliminate malignant cells while sparing healthy tissue. The therapy’s mechanism of action orchestrates a cellular symphony, with engineered gamma-delta T cells acting as lead violins, precisely targeting cancer cells. This precision is complemented by the supporting sections of the immune system, providing a robust backdrop of defense. Dr. Lawrence Lamb, IN8bio’s scientific co-founder, emphasizes the therapy’s potential to reduce relapse risk and improve overall survival rates for patients undergoing haploidentical stem cell transplants, highlighting its revolutionary composition in the cancer therapy repertoire.

Promising Leukemia Outcomes

The interim results of INB-100 have struck a resonant chord within the medical community, offering a glimmer of hope in the challenging landscape of high-risk leukemias. Remarkably, all treated AML patients in both the original and expansion cohorts through January 17, 2025 remain in complete remission. The original cohort of AML patients has reached a median CR of 23.3 months, with several patients in remission for over three years. The median duration across all treated AML patients (N=9) is 20.1 months.. This longevity is particularly noteworthy given the typically aggressive nature of myleoid leukemias and their propensity for relapse. The absence of severe acute Graft versus Host Disease (aGvHD) further underscores the therapy’s promise, suggesting a favorable safety profile that could significantly improve the quality of life for patients undergoing haploidentical stem cell transplants.

Future Impact on Cancer Care

The potential impact of INB-100 on cancer care extends beyond its immediate application in leukemia treatment. If successful in larger-scale trials, this innovative gamma-delta T cell therapy could pave the way for a new paradigm in cellular immunotherapy, potentially benefiting patients with various hematological malignancies. The therapy’s ability to induce durable remissions without severe side effects may significantly improve long-term outcomes and quality of life for transplant recipients. As the oncology community eagerly awaits further data, INB-100 stands poised to potentially reshape treatment protocols and offer new hope to patients who have exhausted conventional options. We expect IN8bio to present the 2025 A,merican Society of Hematology Annual Meeting which they have in years past. The company’s innovative approach could potentially rewrite the score for leukemia treatment, offering a new movement in the symphony of cancer care. While the melody of success resonates through these early results, the scientific community remains cautiously optimistic. As with any groundbreaking therapy, the true test lies in larger-scale trials and long-term follow-ups. Nevertheless, INB-100 has undoubtedly struck a hopeful chord in the ongoing battle against leukemia, potentially heralding a new era in cellular immunotherapy. In the grand opera of medical advancement, IN8bio’s gamma-delta T cell therapy may well be the aria that changes the narrative for leukemia patients worldwide. As we await the full recital of results, one thing is clear: the oncology stage is potentially set for a performance that could resonate for generations to come.

What Does Leadership Say About This?

William Ho, Chief Executive Officer and co-founder of IN8bio (NASDAQ: INAB)

“We’re incredibly pleased with our efforts to continue to deliver consistent, long-term remission results with INB-100. It’s rare to see 100% relapse-free survival in high-risk AML patients, especially over a prolonged period. For patients who may not have had a clear path forward in the past, INB-100 is providing hope, extending survival, and demonstrating the potential to change the standard-of-care. What makes this even more exciting is the safety profile we’ve observed. Gamma-delta T cells are showing that they can do the job of fighting residual cancer cells without causing significant side effects like CRS or neurotoxicity—issues that often plague other cell therapies. As we continue to enroll patients and expand the trial network, we are working diligently to lay the groundwork for the future regulatory pathway towards a potential registrational trial. The IN8bio team is working hard to de-risk the future path to approval and to bring this innovative therapy towards broader patient access. We are committed to providing further updates later this year as we build momentum toward this goal.”

More About William Ho, Director, President, CEO, and Co-Founder

William Ho is a company Co-Founder and has served as our President, Chief Executive Officer, and Director of IN8bio since its inception. Mr. Ho has worked in the biotechnology industry for nearly 24 years. Prior to the founding of IN8bio, from 2014 to 2017, Mr. Ho was the Founder and Managing Partner at AlephPoint Capital, a private healthcare investment fund. Prior to that, Mr. Ho was at New Leaf Venture Partners, a leading healthcare venture capital firm, where he launched and managed the public investments and cross-over portfolio and served as its Public Investment Director from 2010 to 2014. Previously, Mr. Ho served as a Senior Equity Research Analyst at Bank of America from 2006 to 2009 and an Equity Research Analyst at Piper Jaffray & Co. from 2003 to 2006, covering the biotechnology and life-science tools sectors. Earlier in his career, Mr. Ho was responsible for FP&A and operational analysis at CuraGen Corporation and worked as an Associate on the Healthcare Investment Banking team at Cowen, Inc. Mr. Ho was an inductee into the McMaster University Alumni Gallery in 2020 and previously served as a member of their Dean’s Advisory Board for the Faculty of Science. Mr. Ho received an MBA from the University of Notre Dame and a B.S. in Biochemistry from McMaster University.

More About The DeltEx™ Platform

According to IN8bio’s website, The DeltEx™ platform has enabled a deep pipeline of preclinical and clinical product candidates designed to effectively target and potentially eradicate cancer cells to improve patient outcomes.

Key elements of our approach to treating cancer include:

Advanced expertise in the manufacturing of ex-vivo, expanded, activated gamma-delta T cells
First-in-class proprietary gamma-delta T cell engineering for chemotherapy resistance
Advanced next-generation, closed-system, scalable, gamma-delta T cell manufacturing
Broad applicability of our engineered DeltEx cells across multiple solid and hematological cancer indications

The innate and adaptive immune responses play critical roles in the fight against cancer. While both systems possess important functions, the most effective tumor killing occurs when they work together. Gamma-delta T cells are a unique subset of immune cells that sit at the nexus of the innate and adaptive systems and possess properties of both. Their multifunctional nature and complex receptor repertoire allow them to distinguish between healthy and cancerous cells. They can effectively kill tumor cells directly as well as recruit and activate additional immune effector cells to target and eradicate the tumor. Notably, gamma-delta T cells can eliminate cancer cells without prior antigen priming and have the ability to antigen present and trigger a broader immune cell response. These properties make gamma-delta T cells promising candidates for use in for both solid and hematological cancer therapies.

IN8bio’s DeltEx™ platform is designed to overcome many of the challenges associated with the expansion, genetic engineering and scalable manufacturing of gamma-delta T cells, allowing the team to harness their unique properties for cancer therapies. IN8bio’s core technology is a novel concept in cellular therapy, drug resistant immunotherapy, or DeltEx™ DRI, which uses intracellular engineering to generate gamma-delta T cells that are resistant to different classes of chemotherapy. These cells can be used in early and frontline treatment settings where they can survive combinations with therapeutic doses of chemotherapy. Chemotherapy, a mainstay of solid tumor treatment, can deplete and damage immune cells, including gamma-delta T cells, limiting their ability to seek and kill tumors. Chemotherapy treatment can also result in the selection of residual tumor cells that are chemotherapy resistant, which leads to disease recurrence. They have leveraged their proprietary genetic modifications to protect their DeltEx™ DRI cells from chemotherapy-induced damage, allowing for their concomitant delivery with chemotherapy so they can identify and kill residual tumor cells when the tumor is experiencing maximum chemotherapy-induced stress. This DeltEx™ DRI approach is the basis for several of our programs, including INB-200 and INB-400.

by John F. Heerdink, Jr. February 10, 2025

Indaptus Emerging With Potential Keytruda Partner or Competitor – ( $MRK $INDP $IBB )

Indaptus Therapeutics (NASDAQ: INDP), a clinical-stage biotechnology company pioneering innovative cancer and viral infection treatments, has received approval from Health Canada to expand its clinical trial of Decoy20, a promising cancer treatment, into Canada, broadening patient recruitment for its ongoing U.S.-based INDP-D101 trial and potentially advancing the field of combination immunotherapy.

Indaptus Expands Decoy20 Trial

Health Canada’s approval marks a significant milestone for Indaptus Therapeutics, allowing the expansion of its INDP-D101 clinical trial beyond U.S. borders. This development not only broadens patient recruitment but also enhances the diversity of data collected, potentially accelerating the evaluation of Decoy20 as a broad immune system activator for solid tumors. The trial’s weekly dosing regimen aims to assess both safety and efficacy, with Indaptus demonstrating a forward-thinking approach by planning to seek approval for a combination trial pairing Decoy20 with BeiGene’s PD-1 checkpoint inhibitor. This strategic move aligns with the growing trend in cancer research towards innovative combination therapies, positioning Indaptus at the forefront of cutting-edge cancer treatment development.

Decoy20’s Pulse-Prime Approach

Decoy20’s innovative “Pulse-Prime” approach delivers a robust yet short-lived immune response, potentially complementing checkpoint inhibitors like Keytruda by amplifying their effectiveness while minimizing side effects. This unique mechanism of action could address a critical need in cancer treatment by providing a powerful initial immune stimulation without prolonged systemic effects. Preclinical studies have shown promise for Decoy20 as a synergistic agent, suggesting its potential to enhance the efficacy of existing immunotherapies when used in combination. As the field of oncology continues to evolve, Decoy20’s distinctive approach may offer a valuable new tool in the growing arsenal of cancer-fighting therapies.

Keytruda’s Role in Immunotherapy

Merck’s (NYSE: MRK) Keytruda (pembrolizumab) has set a high bar in the field of immunotherapy, demonstrating remarkable success in improving survival rates across various cancer types. KEYTRUDA is an immunotherapy that works by: (1) Blocking the PD-1 protein on T cells, (2) Helping the immune system detect and fight cancer cells more effectively, & (3) Reactivating the body’s natural defenses against cancer. This innovative approach allows KEYTRUDA to harness the power of the patient’s own immune system to combat cancer. When combined with chemotherapy, Keytruda has shown a 27% reduction in the risk of death for patients with metastatic triple-negative breast cancer. The drug’s versatility is further exemplified by its approval for 30 indications in the European Union, including five in gynecologic cancers. Keytruda’s success in combination therapies extends to advanced renal cell carcinoma when paired with axitinib, and it has received FDA approval for use in combination with gemcitabine and cisplatin for biliary tract cancer. These achievements underscore the potential for combination approaches in immunotherapy, paving the way for emerging treatments like Decoy20 to explore similar synergistic effects in the fight against cancer.

Advancing Cancer Treatment Paradigms

The expansion of Indaptus Therapeutics’ INDP-D101 trial to Canada represents a significant stride in advancing cancer treatment paradigms. This development not only broadens patient recruitment but also enhances the potential for generating more comprehensive clinical data. The company’s innovative approach, combining Decoy20 with checkpoint inhibitors, aligns with the growing trend of combination immunotherapies that have shown promise in improving patient outcomes. Jeffrey Meckler, CEO of Indaptus, expressed optimism about this milestone, emphasizing the importance of Canadian participation in strengthening the clinical dataset. As the oncology landscape evolves, Decoy20’s unique “Pulse-Prime” mechanism could offer a complementary approach to established therapies, potentially redefining treatment strategies for solid tumors.

All Posts

The Drug: VYKAT XR

Market Opportunity

Analyst Reactions and Stock Performance

Commercial Strategy

Beacon Of Hope

Citations:

Indaptus Q4 Financial Results

Decoy20 Clinical Progress

The Indaptus Approach

Strategic Goals for 2025

CMO360 Summit April 7-8 Boston

Citations:

GeoVax’s Innovative Technologies

Clinical Trials and Pipeline

Vaccine Market Growth Potential

Key Milestones Achieved In The past year

BARDA Project NextGen Award for GEO-CM04S1:

Opportunities with GeoVax

Learn More

Citations:

Precision Neuro-Oncology Advances

STAR-001 vs. Dordaviprone

Future Neuro-Oncology Trends

Last Idea Of The Day

The Orchard of Opportunity

The Core of the Matter

A Fruitful Future?

Citations:

More in TECH….!

Pebble’s Announces Participation in the Nvidia Developer Ecosystem to deliver Pebble-falcon Energy Aware Cloud Solution

Data Center and its rising energy demands

Energy aware computing using pebble-falcon

Optimizing for AI models for Energy Efficiency

NVIDIA Developer Program

1 https://www.epri.com/research/products/3002028905

2 https://www.forbes.com/sites/johnwerner/2025/01/09/jensen-huang-at-ces-agentic-ai-big-hardware-and-more/

3 https://www.iea.org/commentaries/what-the-data-centre-and-ai-boom-could-mean-for-the-energy-sector

4 https://docs.aws.amazon.com/awsaccountbilling/latest/aboutv2/ccft-estimation.html

5 https://blog.google/outreach-initiatives/sustainability/carbon-aware-computing-location/

6 https://cloud.google.com/sustainability/region-carbon

7 https://www.nature.com/articles/d41586-024-02680-3

Citations:

INB-100 Trial Results

Gamma-Delta T Cell Mechanism

Promising Leukemia Outcomes

Future Impact on Cancer Care

What Does Leadership Say About This?

More About William Ho, Director, President, CEO, and Co-Founder

More About The DeltEx™ Platform

Indaptus Expands Decoy20 Trial

Decoy20’s Pulse-Prime Approach

Keytruda’s Role in Immunotherapy

Advancing Cancer Treatment Paradigms

Your Guide To Staying Informed In The Markets

: