Greenwich LifeSciences: Persevering CEO And Interesting Data

Greenwich LifeSciences, Inc. (NASDAQ:GLSI) is a developer of cancer immunotherapies for breast cancer and other HER2/neu-expressing cancers. A 2-year IPO with a 2 decades history, GLSI had been lagging over an FDA clinical hold that was placed on its Phase III clinical trial, FLAMINGO-01, citing manufacturing and pharmacy process issues. The stock seems to have stabilized after that, however, at $8 today, it is still nowhere near its 52-week high of $48.

GLSI’s lead product candidate is GLSI-100, which is a combination of GP2 and GM-CSF. GP2 is a “9 amino acid transmembrane peptide of the HER2/neu protein, a cell surface receptor protein that is expressed in a variety of common cancers.” This is developed at GLSI. To this is added a GM-CSF, or a recombinant human granulocyte macrophage colony-stimulating factor (sargramostim, Leukine®), a well-known, previously approved molecule.

The company is currently running a phase 3 trial led by Baylor and a ​”consortium of prominent cancer centers.” A phase 2b trial led by MD Anderson produced solid data. Data was:

0% recurrences over median 5 years follow-up, if fully immunized, versus 11% placebo recurrence rate in 96 patients (p = 0.0338), peak immunity after 6 months, minimal to no side effects, no SAEs attributable to GP2

These patients were on a previous treatment with Herceptin or Kadcyla. The data here not only demonstrates GP2’s excellent profile, it also shows that the two other legacy treatments are also highly effective in this population. The opportunity, therefore, lies in those 50% of recurring disease patients who do not respond to these standards of care. As the company says:

Following breast cancer surgery, HER2/neu 3+ patients receive Herceptin in the first year and then hope that their breast cancer will not recur, with the odds of recurrence slowly decreasing over the first 5 years. Herceptin reduces recurrence rates from 25% to 12%. GP2 & GM-CSF starting in Year 2 act synergistically with Herceptin to prevent cancer recurrences, if fully immunized, reducing recurrence rates from 11% to 0% at median 5 years follow-up (p = 0.0338), with minimal to no side effects & no SAEs.

This synergistic treatment effect could save 1500 to 2000 patients per year from the 17000 patients that could be treated under GLSI-100’s initial indication alone.

This phase 2b trial was completed in 2018, before the company’s IPO in 2020. This company has been in existence since 2006. They were supposed to launch the phase 3 trial in 2020 itself; however, constant delay is the major reason the stock has been a laggard. The other reason, at least in the early days, was the company’s failure to properly communicate its data to the investing public. A poster presentation at the San Antonio Breast Cancer Symposium (SABCS) in late 2020 finally brought the company to public notice, and there was a major spike in share price for a short period thereafter.

Financials

GLSI has a market cap of $110mn and a cash balance of ~$17mn as of June. The company spent $773,000 in R&D + G&A during the quarter. This is possible because the company is almost entirely a one-man operation, with CEO Mr. Snehal Patel running everything, virtually. They recently hired 2-3 senior management people.

The company recently entered a $100mn open market sale agreement with Jefferies as the agent. The company also had a stock buyback program running, through which it purchased ~520K shares for ~$7.5M. They have now stopped this program.

Bottom Line

Some of the data here is attractive, but I am not sure how much confidence the financial and management aspect of this company can generate. On the other hand, the CEO’s perseverance against all odds is to be commended. Just out of curiosity, I will continue watching this company, although I am not a buyer right now.

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