Immunomedics: A Breakthrough On Commercialization Could (Finally) Be Imminent

Nov. 26, 2019 12:56 PM ETImmunomedics, Inc. (IMMU) StockIMMU7 Comments

Summary

  • Commercialisation of flagship investigational antibody-drug conjugate sacituzumab govitecan (SG) stalled after FDA rejected the biologics licensing application in Jan. '19.
  • Rejection caused by chemistry, manufacturing, and control issues plus reported data integrity breaches. CEO Michael Pehl resigned shortly after the verdict. CMO Rob Iannone also left in April.
  • After meeting with FDA in September, IMMU plans to resubmit application imminently.
  • Clinical trials suggest the efficacy of sacituzumab govitecan, and IMMU plans to commercialise on its own in the US and has granted a license to Everest Medicines for commercialisation in China.
  • IMMU has failed to commercialise a drug in 35+ years of trying but the new management team could deliver despite recent setbacks.

Investment Thesis

I think Immunomedics (IMMU) is an interesting investment opportunity. The company had become known for its inability to commercialise new drug candidates (35 years of trying, no successes). But current management apparently fought hard to take control of the company and prevent the sale of its flagship drug sacituzumab govitecan to Seattle Genetics (SGEN). There is a wealth of positive data surrounding this antibody drug conjugate that can deliver moderately toxic drug SN-38 to where its needed by combining it with a humanised antibody that targets the TROP 2 receptor.

Sacituzumab govitecan can potentially be used to treat third-line and first-line breast cancers, most notably triple negative breast cancers and also urothelial cancer. Despite a BLA being rejected by the FDA in January '19, the company says its ready to resubmit the application, and if successful, commercialisation would be imminent. Hence, I believe a good strategy would be to buy and hold IMMU stock in anticipation of successful commercialisation.

Company History: The Battle For A Long-Awaited Prized Asset

Can Immunomedics put 35+ years of failure behind them and finally commercialise a drug candidate?

Yes, there is certainly a bear case to be made about this company, and in fact, there have been some notable ones written on these pages. But that was then, and this is now.

Immunomedics today is practically unrecognisable from the husband and wife team of David and Susan Goldenberg that were unable to capitalise on as many as 23 orphan drug designations up to 2017, failing to obtain FDA approval to bring any of them to market.

The Goldenbergs were ousted in a boardroom coup back in 2017 by activist investors VenBio (now known as Avoro Capital Advisors), who had built up a 10% stake in the company and were determined to prevent IMMU from

This article was written by

13.4K Followers

Edmund Ingham is a biotech consultant. He has been covering biotech, healthcare, and pharma for over 5 years, and has put together detailed reports of over 1,000 companies. He leads the investing group Haggerston BioHealth.

The group is for both novice and experienced biotech investors. It provides catalysts to look out for and buy and sell ratings. It also provides product sales and forecasts for all the Big Pharmas, forecasting, integrated financial statements, discounted cash flow analysis and market by market analysis. Learn more.

Analyst’s Disclosure:I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

Seeking Alpha's Disclosure: Past performance is no guarantee of future results. No recommendation or advice is being given as to whether any investment is suitable for a particular investor. Any views or opinions expressed above may not reflect those of Seeking Alpha as a whole. Seeking Alpha is not a licensed securities dealer, broker or US investment adviser or investment bank. Our analysts are third party authors that include both professional investors and individual investors who may not be licensed or certified by any institute or regulatory body.

Recommended For You

More on IMMU