Summary
- A third patient dosed last quarter should have 12-week data next month.
- However, the company promised a mid-year readout.
- Its cell therapy library is expanding, although really not doubling its potential market.
Last month, Alaunos Therapeutics ( TCRT ) highlighted its expected milestones and strategic priorities for 2023. Prices for the small (now $140 million market cap) oncology-focused cell therapy company had plunged 40% since initial coverage in Nov ember. Since then, the company successfully dosed its third patient in December and added two new anti-tumor reactive T-cell receptors (TCRs) to its clinical trial. Investors should become familiar with the implications of these developments.
The third patient has pancreatic cancer with a KRAS-G12V mutation. Alaunos had added a human leukocyte antigens (HLA) gene form to its existing KRAS-G12V mutation library (Table 1) and a new mutation within the targeted TP53 gene family. As a reminder, the first patient was dosed in May 2 with clinical data reported on September 6 , while the second patient dosed by August 9 at the latest had 12-week data on November 14. Investors should note that it took longer to announce ok results (partial response for Patient 1) than the clinically worse ‘stable disease’ for Patient 2. Furthermore, neither KRAS-G12V & HLA-DRB1*07:01 nor TP53-R273C & HLA-DPB1*04:02 are currently in the TCR001-201 study listing, which hasn’t been updated since December 14.
Table 1. Alaunos’ TCR Library
Gene | Mutation | Mutation frequency (%) | HLA restriction | HLA frequency (%) | Potentially treatable patient (%) |
G12D | 3.60 | A*11:01 | 12.2 | 0.44 | |
G12D | 3.60 | C*08:02 | 7.7 | 0.28 | |
G12V | 2.90 | A*11:01 | 12.2 | 0.35 | |
G12V (New) | 2.90 | DRB1*07:01 | 26.8 | 0.78 | |
R175H | 5.53 | A*02:01 | 47.4 | 2.62 | |
R175H | 5.53 | DRB1*13:01 | 10.0 | 0.55 | |
R248W | 3.22 | A*68:01 | 6.4 | 0.21 | |
Y220C | 1.79 | A*02:01 | 47.4 | 0.85 | |
Y220C | 1.79 | DRB3*02:02 | 32.8 | 0.59 | |
R273C (New) | 2.26 | DPB1*04:02 | 24.2 | 0.55 | |
E746-A750del | 7.20 | DPB1*01:01 | 12.4 | 0.89 |
Phenotype mutation frequency is for Caucasian populations in the U.S.; when the phenotype frequency is not available, twice the allele frequency from The Allele Frequency Net Database is reported. According to the International Agency for Research on Cancer (IARC) TP53 Database, rates for R273C are 60%-80% in Hispanic populations, and approximately 20% in African-American and Asian populations. |
Chief Executive Officer Kevin S. Boyle, Sr., claimed that, “with the addition of two new TCRs to our library we have doubled the potential addressable market of our therapy.” However, according to Table 1, which measures the treatable patients as a proportion of all cancers, the TAM increased from 6.7% to 8.1%. On the other hand, perhaps he meant doubling the targeted tumor indications (Table 2). In which case, for the KRAS family, the TAM did climb from 6.1% to 10%.
Table 2. KRAS mutation frequencies in Alaunos’ targeted tumor indications
KRAS mutation | Cholangiocarcinoma | Colorectal | Lung | Ovarian | Pancreatic |
New Cases | |||||
G12D (%) | 46 | 32.9 | 19.2 | 37.4 | 46 |
G12V (%) | 18.8 | 20.4 | 21.3 | 38.1 | 30.4 |
Financials
A week after previous coverage, Alaunos executed a public offering of 24,228,719 shares , gaining $14.6 million in net proceeds in exchange for 11.2% dilution. At $0.6191 per share, the buyers received a 29% initial discount, but shares have been volatile, ranging from $0.5 to $0.85 since the secondary. By January 4, TCRT had closed below the required $1 minimum per share for 30 consecutive business days to earn Nasdaq’s delisting warning and prices have again dipped below the $0.60 range. Nevertheless, with the $37.8 million cash as of Q3 2022 and $2.5 million restricted cash becoming available in a couple of months, the company now has enough funds to see itself through a mid-year catalyst.
Risks and Takeaways
Alaunos remains a speculative biotech in a bear market with no approved products with the same risks as before, including high volatility, lack of revenues, and no guarantee that their brand of non-viral TCR-T cell therapy would ultimately work (i.e., produce a complete response). The company expects to enroll multiple patients in the first half and provide an interim data update by mid-2023. Until then, TCRT stock may be better suited for day traders. Alternatively, the option chain includes October 20 and January 2024 for those who recognize the difficulty of timing the catalysts. Finally, investors should be again prepared for more dilution shortly following the update, as the November financing only bought the company an extra 4-5 months.
For further details see:
Alaunos Therapeutics: Data Delayed