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Background
Old News
Latest Developments
Upcoming Catalyst
Technicals/Notes
Background
- A clinical-stage company developing a novel medicine, ALRN-6924, to improve the outcomes and the quality of life of cancer patients
- ALRN-6924= in P1b as a novel chemoprotective agent to treat/ protect healthy cells in patients with p53 mutations to reduce or eliminate chemotherapy-induced side effects
- 50% of all cancer patients across multiple tumor types have a p53 mutation
- For an overview of ALRN’s clinical development programs, click here
- Â ALRN-6924 has achieved clinical proof of concept in p53-mutated small cell lung cancer (SCLC)
- ALRN-6924= is the first and only reported chemoprotective agent in clinical development to use a biomarker to ensure selective chemoprotection of healthy cells without protecting cancer cellsÂ
Old News
- Closed a $36M direct offering @ $1.10 with participation by new investors:
-  New investors= big-name healthcare-focused firms including Acorn Bioventures, BFV Partners, L.P., and Maven Investment Partners
- Expanded enrollment in its P1b study in advanced p53-mutated NSCLC;Â 3/2/21
- The study is randomized, double-blinded, and has a placebo control
- Regulatory ptwy now clarified for chemoprotection following FDA approval of GTHX’s first-generation chemoprotective drug (COSELA) in Feb 2021
Latest Developments
- Hosted a KOL call with investors to discuss the new market opportunity for protecting cancer patients from toxic chemotherapy; 5/26/21
- Click here to listen
- Added to the Russel Small Cap Index;Â 6/24/21
- Initiated the P1b study;Â 7/1/21Â Â
- Interim data expected by end of year
- Final results are expected in mid-2022
- Presented at the William Blaire investor conference; 7/15/21
- Click here to listen
- Highlights from 1Q21 earnings; 5/11/21
- Abstract co-authored with Foundation Medicine on TP53 mutations was accepted for presentation at ASCO (June 4-8th)
- Foundation Medicine was acquired by Roche (RHHBY) for $2.4B in 2018
- Strong financial position with $68M in cash paving a runway into 2H23
- Raised $23M through an ATM selling the stock at an avg price of $1.64
- Abstract co-authored with Foundation Medicine on TP53 mutations was accepted for presentation at ASCO (June 4-8th)
Upcoming Catalyst
- Interim P1b data for ALRN-6924 (by end of 2021)
- Final P1b data (mid-2022)
Technicals/Notes
- In our view, the approval of GTHX’s chemoprotective product (COSELA) earlier this year validates the company’s developmental strategy for ALRN-6924
- In its first quarter of sales, GTHX pulled $14M
- Furthermore, COSELA was added to Two National Comprehensive Cancer Network® (NCCN) guidelines which inform reimbursement and formulary decisions
- In our view, this validates the unmet medical need filled by a chemoprotective agent and physician acceptance of one that meets the FDA’s rigorous standards
