BULL THESIS
GTHX overall corporate and summary
Commercial-stage cancer biopharma company focused on the development and commercialization of COSELA™ (trilaciclib).
Pipeline in a compound
Attractive Enterprise Value of ~$300M (3/10/22) for commercial company with promising new commercial agent with a lot of upside in current approved indication (SCLC) and especially with other possible future indications
Estimated market value for ES-SCLC ~$700M.
COSELA currently only penetrates 3% of the SCLC market while market data suggests that most physicians intend to prescribe COSELA.
Company OK with 2022 revenue consensus of $46M/yr (over 300% increase over $10M in 2021)
Currently deploying GTHX’s own sales team for better access and focus on largest potential prescribing accounts
Initial unsuccessful commercialization by large pharma partner was due to poor access of sales reps to key accounts.
G1 sales reps are apparently doing well in early 7 territories
Cash Runway expected to 2024
$221M in cash/equiv (12/31/21).
Includes $75M drawn from $150M debt facility. $25M available Source.
Trilaciclib approval in China for SCLC expected by partner Simcere later in 2022.
Potential for $475 million in milestone payments (as of 9/30/21) plus royalties
COSELA appears to save the healthcare system money by reducing myelosuppressive events, which is reflected in good insurance coverage
COSELA™ Trilaciclib (G1T28) (CDK4/6 inhibitor) SCLC (Small Cell Lung Cancer)
Approved 2/2/21
~$21 -> ~$30 increase in stock price after approval.
Currently ~20K Eligible ES-SCLC Patients
Q3 2021 product sales $3.6M (60% growth over Q2 2021)
Added to NCCN Guidelines in 2021.
GTHX's own COSELA-focused sales team fully deployed February 2022.
Only product offering proactive multilineage myeloprotection to decrease the incidence of chemotherapy-induced myelosuppression in ES-SCLC.
Trilaciclib approval in China expected by partner Simcere, royalties and milestones expected.
Trilaciclib (Cosela) (CDK4/6 inhibitor) CRC (Colorectal Cancer) and Breast Cancer
CRC registrational trial now reading out in early Q1 2023
Myeloprotection primary endpoint for FOLFOXIRI chemo hits on strength of Cosela
Strong support from preclin work
PRESERVE 2, pivotal phase 3 trial in TNBC initiated April 2021.
Topline data expected H2 2023
Improvement in Overall survival in 2 of 3 cohorts. (source)
Compared to GC alone (Group 1),
OS was improved in both trilaciclib arms (Groups 2 and 3) (Group 2: HR=0.31, p=0.0016; Group 3: HR=0.40, p=0.0004). Median OS was 12.6 months in Group 1, not reached for Group 2, and 17.8 months in Group 3. The median OS for Groups 2 and 3 combined was 19.8 months (HR=0.37, p<0.0001). The median OS for control GC alone (Group 1, 12.6 months)
Strong evidence for PRESERVE 2 readout in 2023.
Trilaciclib (Cosela) (CDK4/6 inhibitor) Bladder Cancer
Building on strong rationale for trilaciclib + chemo + checkpoint inhibitor;
Data to date suggest potential for synergistic effect in known immunogenic tumor. (Source)
PRESERVE 3 , Phase 2 initiated June 2021. Initial data expected H2 2022.
Market; 20k patients currently receiving Chemotherapy for bladder cancer.
Trilaciclib (Cosela) (CDK4/6 inhibitor) combination with the antibody-drug conjugate (adc), trodelvy®. TNBC.
Phase 2 initiated November 2021, data expected H2 2022.
Rintodestrant
Monotherapy Phase 1b data showed rintodestrant to be a strong ER target with anti-tumor activity
Currently evaluating partnering options for continued development.
JM/MV 3/10/22 (Updated MV 3/13/22)
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