"Patience is a Super Power" - "The Money is in the waiting"
Showing posts with label Therapies. Show all posts
Showing posts with label Therapies. Show all posts

Friday, January 31, 2025

How Viking Therapeutics is challenging Eli Lilly and Novo Nordisk in the weight loss (anti-obesity) therapeutics market!

 


Viking Therapeutics (VKTX) Investment Report

January 2025


1. Executive Summary

Viking Therapeutics (NASDAQ: VKTX) has emerged as a key contender in the rapidly growing weight-loss (anti-obesity) therapeutics market—a space that has recently been dominated by Novo Nordisk (Novo) and Eli Lilly (Lilly). While the competition among established players remains formidable, Viking Therapeutics is drawing significant investor and industry interest due to:

  1. Late-stage injectable GLP-1/GIP program entering Phase 3 trials in 2025.
  2. Oral GLP-1/GIP candidate in mid-stage trials that could offer a more convenient regimen.

Analysts covering VKTX are largely bullish: all 14 analysts on FactSet rate it a “Buy,” with a consensus price target around $112 (versus recent trading levels near $34). Roger Song at Jefferies, for instance, maintains a $110 target, citing Viking’s innovative dual-hormone pipeline as a primary catalyst for outsized upside.


2. Company Overview

Founded with a focus on metabolic and endocrine disorders, Viking Therapeutics has spent the past several years developing treatments that leverage the body’s own hormonal pathways to address obesity and related metabolic conditions (e.g., type 2 diabetes). With considerable expertise in liver- and endocrine-related R&D, Viking’s mission has broadened to include advanced therapeutic platforms that combine:

  • GLP-1 (Glucagon-Like Peptide-1): Known to regulate blood sugar levels and appetite control.
  • GIP (Glucose-Dependent Insulinotropic Polypeptide): Potentially amplifies insulin secretion and promotes additional weight loss benefits.

Viking’s research focuses on optimizing both efficacy and tolerability, aiming to create best-in-class therapies that rival or surpass existing drugs in the marketplace.


3. Market Opportunity

a) Expanding Obesity Drug Market

  • Prevalence of obesity continues to climb globally, prompting growing demand for more effective, safer treatments.
  • The success of Novo Nordisk’s and Eli Lilly’s GLP-1 products has accelerated investment into next-generation weight-loss therapies—forecasted to be a multibillion-dollar market for the foreseeable future.

b) GLP-1/GIP Combination Potential

  • Early data from dual or multi-hormone agonists indicate that they may provide superior weight-loss efficacy to single-hormone therapies.
  • In addition to weight reduction, GLP-1/GIP agonists can help improve metabolic markers such as blood glucose, making them attractive for long-term management of obesity and diabetes.

4. Pipeline Overview

  1. VK-XYZ (Injectable Dual GLP-1/GIP) – Phase 3 (2025)

    • Mechanism of Action: Targets dual gut hormone pathways, aiming to deliver potent appetite suppression and improved glycemic control.
    • Key Milestones: Phase 3 initiation is slated for 2H 2025, following encouraging Phase 2 data showing robust weight loss and an acceptable safety profile.
    • Competitive Edge: Could potentially differentiate on efficacy, with a strong possibility of favorable tolerability (e.g., fewer gastrointestinal side effects) based on prior trial readouts.
  2. VK-ABC (Oral GLP-1/GIP) – Phase 2 (Ongoing)

    • Mechanism of Action: Same dual-hormone concept, but in oral capsule/tablet form.
    • Key Milestones: Mid-stage trials (Phase 2) began in late 2024, with an expected data readout in early 2026.

    • Competitive Edge: If proven effective, an oral GLP-1/GIP drug could address patient preferences for non-injectable therapies, enhancing adherence and broadening the potential market.
    • Long-Term Use Case: Especially attractive for patients who have already achieved initial weight loss with injectable therapy and wish to transition to an oral maintenance treatment.

5. Financial Position and Analyst Outlook

  • Balance Sheet Strength: Viking has maintained a conservative burn rate relative to peers, aided by periodic equity raises in prior years. As of the latest data, the company reported a solid cash runway—enough to carry it through key clinical milestones in 2025 and beyond.
  • Analyst Consensus:
    • All 14 analysts covering the stock currently rate VKTX a “Buy.”
    • Average Price Target: $112, implying a ~230% upside from current levels around $34.
    • Jefferies Analyst Roger Song provides a $110 price target, driven by robust Phase 3 prospects and the potentially “best-in-class” nature of the oral pipeline.

6. Investment Considerations

a) Key Strengths

  1. Innovative Pipeline: The dual-hormone GLP-1/GIP approach is widely regarded as a logical next step in anti-obesity treatments.
  2. Potentially Differentiated Oral Candidate: If clinical data confirm efficacy and tolerance in longer-term use, the oral agent could represent a game changer in the maintenance phase of obesity treatment.
  3. Strong Analyst Sentiment: Unanimous Buy ratings underscore an unusually high level of confidence across Wall Street.

b) Risks and Challenges

  1. Clinical Trial Outcomes: Despite promising Phase 2 data, any unexpected adverse events or underwhelming efficacy in Phase 3 could negatively impact the investment thesis.
  2. Regulatory Hurdles: The FDA and other global regulatory bodies have strict guidelines for obesity drugs, especially regarding cardiovascular and hepatic safety.
  3. Competitive Pressure: Novo Nordisk and Eli Lilly, as well as emerging biotech rivals, are rapidly advancing next-gen therapies. Viking must demonstrate clear differentiation or risk being overshadowed.
  4. Commercialization and Partnering: Should Viking move toward approval, the cost and complexity of launching and marketing weight-loss therapies globally will be significant. Licensing or partnership arrangements may be needed to scale effectively.

7. Valuation Scenarios

  1. Base Case (~$110–$112 Target)

    • Assumes successful Phase 3 data for the injectable candidate and promising Phase 2 results for the oral program.
    • Sees potential for first regulatory approvals in late 2026 or 2027, with a commercial rollout beginning shortly thereafter.
    • Models a moderate partnership strategy to handle international launches.
  2. Bull Case (Above $120)

    • Projects stronger-than-expected efficacy data and a clean safety profile, accelerating approval timelines.
    • Oral candidate emerges as a leading obesity maintenance therapy, capturing significant market share faster than anticipated.
    • Potential licensing deals or acquisitions further improve the company’s financials.
  3. Bear Case (Sub-$30)

    • Delays or failures in trials, or significant competition from larger pharma entrenches.
    • Safety concerns emerge, limiting the treatable population or requiring cautionary labels.
    • Dilutive financing becomes necessary, pressuring share price.

8. Conclusion and Recommendation

Viking Therapeutics stands at an inflection point in the race to develop next-generation weight-loss treatments. Driven by a robust pipeline targeting both injectable and oral dual GLP-1/GIP therapies, Viking could capture a meaningful slice of an expanding obesity market—particularly if its Phase 3 and Phase 2 trials deliver strong data on efficacy and tolerability.

Investment Thesis:

  • High-risk, high-reward proposition, given the advanced stage of the pipeline and the unanimous bullish analyst outlook.
  • Patient, risk-tolerant investors may find the current share price (~$34) an attractive entry, with a broad analyst consensus pointing toward $110–$112.

Nevertheless, potential investors should monitor ongoing clinical progress, competitive developments, and any regulatory guidance shifts. As with any biotechnology investment, diversification and rigorous due diligence are advised.

ED note: we are long VKTX stock


Disclaimer: This report is provided for informational purposes only and does not constitute investment advice or a recommendation to buy or sell any security. Always conduct your own research and consult a qualified financial advisor before making investment decisions.

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"NASH" is a serious healthcare problem and it is one important reason why Viking Therapeutics might become a takeover target!

Saturday, June 22, 2024

Agenus Inc. (formerly known as Agenus Therapeutics) is not claiming to be close to a cure for any form of cancer, but they are making significant strides in developing innovative cancer therapies.

 

"The rapid and complete resolution of aggressive MSS colorectal cancer tumors observed in this study is unprecedented in the field" says the author Dr. Kasi




Agenus is focused on immuno-oncology, to leverage the immune system to fight cancer. 

Here are some of their notable developments:

  1. Checkpoint Inhibitors: Agenus has been working on various checkpoint inhibitors, which are drugs designed to block proteins that prevent the immune system from attacking cancer cells. Their pipeline includes anti-CTLA-4 and anti-PD-1/PD-L1 antibodies, which are well-known targets in cancer immunotherapy.

  2. Next-Generation Bispecific Antibodies: These are engineered to bind to two different targets simultaneously. This approach can help direct immune cells more effectively to cancer cells.

  3. Cell Therapy: Agenus has been exploring the potential of cell therapy, particularly with their iNKT cell therapy platform. This involves using engineered invariant natural killer T cells to target and destroy cancer cells.

  4. Neoantigen Vaccines: Agenus has been developing personalized cancer vaccines that target neoantigens, which are unique mutations found in an individual's tumor. This personalized approach aims to enhance the immune response against cancer cells.

  5. Combinations and Partnerships: Agenus is also known for combining their therapies with those of other companies, either through collaborations or licensing agreements. These combinations are designed to improve the efficacy of existing treatments and explore new therapeutic avenues.

While these advancements are promising and show potential in treating various forms of cancer, it is important to note that a "cure" for cancer is a complex and multifaceted goal. Cancer is a group of diseases with diverse characteristics, and what might work for one type of cancer or patient may not work for another. Thus, the focus remains on developing effective treatments that can extend survival and improve quality of life for cancer patients.

The progress of Agenus in clinical trials and their collaborations with other companies in the biotech and pharmaceutical industry are steps towards potentially transformative cancer treatments. However, claiming a cure would be premature without further extensive clinical validation and regulatory approval.

Agenus Inc. has formed several strategic partnerships with various pharmaceutical and biotechnology companies to advance its immuno-oncology pipeline. These collaborations aim to leverage the strengths of each partner to develop and commercialize innovative cancer therapies. Here are some notable partnerships:

  1. Gilead Sciences:

    • In December 2018, Agenus entered into a partnership with Gilead Sciences. Gilead received worldwide exclusive rights to Agenus' bispecific antibody program and access to its proprietary cancer immunotherapy platform. The deal included an upfront payment, potential milestone payments, and royalties on future sales.
  2. Incyte Corporation:

    • Agenus has multiple collaborations with Incyte Corporation. The first, established in 2015, involved the development and commercialization of checkpoint inhibitors targeting GITR, OX40, and TIM-3. In 2017, they expanded their partnership to include an exclusive global license for an undisclosed novel target and additional collaborative work on undisclosed novel antibody candidates.
  3. Merck & Co. (MSD):

    • Agenus has collaborated with Merck to evaluate the combination of Agenus' QS-21 Stimulon adjuvant with Merck's vaccines. QS-21 Stimulon is an adjuvant used to enhance the body's immune response to vaccines.
  4. Betta Pharmaceuticals:

    • In 2020, Agenus partnered with Betta Pharmaceuticals to develop and commercialize balstilimab (an anti-PD-1 antibody) and zalifrelimab (an anti-CTLA-4 antibody) in Greater China. This partnership aims to expand the clinical and commercial reach of these immuno-oncology assets.
  5. UroGen Pharma:

    • Agenus and UroGen Pharma collaborated to explore the potential use of Agenus' anti-CTLA-4 antibody zalifrelimab in combination with UroGen's RTGel™ delivery platform for the treatment of high-grade non-muscle invasive bladder cancer (HG-NMIBC).
  6. Boehringer Ingelheim:

    • In 2021, Agenus entered into a partnership with Boehringer Ingelheim to research and develop novel bispecific antibodies in the field of immuno-oncology. The collaboration includes upfront payments, milestones, and royalties on future sales.

These partnerships highlight Agenus' strategy to collaborate with leading companies to enhance the development and potential commercialization of its immuno-oncology therapies.

Through these collaborations, Agenus aims to accelerate the development of innovative treatments and expand its global reach in the oncology market.

Promising cancer treatments in it's pipeline coupled with a healthy financial book and future royalties positions Xencor for success!

The Human body is highly "Adaptive" in fighting disease, and these two companies are developing technology right now to help that system fight Cancer!


Friday, May 29, 2015

Tiny Company - "Big" Medicine - Sernova Corp - Targetting individual cells with new therapies

According to Rick MIlls who's blog "AheadoftheHerd" is often, exactly that, tiny Sernova Corp is on the verge of something very big in the search for a "safe and compatible device for housing therapeutic cells in human’s".  

It appears that, in the "gold rush" to deliver cutting edge therapies directly the the cells of humans, Sernova will own the "picks and shovels" of that gold rush.



As Rick points out in his well researched report, Sernova's innovative "Cell Pouch™ could be used for any chronic disease where a deficient or missing protein or hormone can be replaced by therapeutic cell transplantation."


Sernova has been developing it's cutting edge technology for many years, and only now has it been independently verified as being a proven method of delivering new cutting edge stem cell therapy for a number of critical diseases including (but not limited to) Diabetes and Hemophilia.



Many other companies, small and large, are researching and perfecting these types of stem cell therapies, Sernova has focused  on the actual delivery mechanism which should benefit "all" of those other companies coming to market with new medicines and therapies.

After all, it was the suppliers of the "picks and shovels, and horses and supplies who made the most money during the great Klondike Gold rush.  It appears that lesson was not lost on the founders of Sernova Corp.

Here is Ricks excellent summary on this rising penny stock..

  Sernova trades on the Toronto Venture Exchange(TSX or TMX)  under the symbol SVA

It traded Monday at .18 cents

Disclosure: I am long SVA!

Link to Patent info