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Currency in USD
Last close As at 25/03/2023
USD0.66
▲ −0.03 (−4.35%)
Market capitalisation
USD11m
Research: Healthcare
On 27 January, the US FDA approved Stemline Therapeutics’ (wholly owned US subsidiary of the Menarini group) elacestrant (Orserdu) as second-line treatment for ER+/HER2-, ESR1-mutated advanced or metastatic breast cancer (mBC), making it the first oral selective estrogen receptor degrader (SERD) to be approved for the indication and the first-ever approved drug for cases with the ESR1 mutation (~40%of all cases in this category). We see this as a material development for Context Therapeutics, which is currently undertaking Phase Ib trials (ELONA trial in collaboration with Menarini) for its drug ONA-XR in combination with elacestrant for the treatment of second/third-line HR+/HER2- mBC. ONA-XR has previously shown promising preclinical data in combination with anti-estrogen therapy, and improved efficacy, if demonstrated in the ELONA trial, should open the door for partnering prospects and create significant market opportunity for Context, in our opinion.
Context Therapeutics |
Elacestrant approval shot in the arm for ELONA trial |
Regulatory update |
Pharma and biotech |
31 January 2023 |
Share price performance
Business description
Analysts
Context Therapeutics is a research client of Edison Investment Research Limited |
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On 27 January, the US FDA approved Stemline Therapeutics’ (wholly owned US subsidiary of the Menarini group) elacestrant (Orserdu) as second-line treatment for ER+/HER2-, ESR1-mutated advanced or metastatic breast cancer (mBC), making it the first oral selective estrogen receptor degrader (SERD) to be approved for the indication and the first-ever approved drug for cases with the ESR1 mutation (~40%of all cases in this category). We see this as a material development for Context Therapeutics, which is currently undertaking Phase Ib trials (ELONA trial in collaboration with Menarini) for its drug ONA-XR in combination with elacestrant for the treatment of second/third-line HR+/HER2- mBC. ONA-XR has previously shown promising preclinical data in combination with anti-estrogen therapy, and improved efficacy, if demonstrated in the ELONA trial, should open the door for partnering prospects and create significant market opportunity for Context, in our opinion.
Year |
Revenue ($m) |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/20 |
0.0 |
(3.2) |
(9.28) |
0.0 |
N/A |
N/A |
12/21 |
0.0 |
(10.6) |
(3.74) |
0.0 |
N/A |
N/A |
12/22e |
0.0 |
(18.1) |
(1.13) |
0.0 |
N/A |
N/A |
12/23e |
0.0 |
(27.4) |
(1.72) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
Despite big pharma’s heavy focus on oral SERDs, Menarini’s elacestrant has emerged as the winner, becoming the first oral drug to receive FDA approval. This follows solid top-line data from its Phase III EMERALD study in December 2021. The study met both primary endpoints, demonstrating a 30% reduction in the risk of disease progression or death versus standard-of-care endocrine therapy (injectable SERD fulvestrant) in the overall population (progression-free survival, PFS of 2.79 months versus 1.91 months for the control group; p=0.0018). This impact was even more pronounced in the cohort with estrogen receptor 1 (ESR1) mutations, reporting a 45% reduction in disease progression (PFS of 3.78 months versus 1.87 months for the control group; p=0.0005). The industry viewed the results for all comers to be driven by the ESR1 cohort and the recent FDA approval for elacestrant, specifically for this category of patients, validates this theory.
Context believes that ONA-XR plus elacestrant will result in a broader inhibition of progesterone and estrogen hormone signaling (drivers for breast cancer growth and metastasis) and therefore a combination treatment could potentially improve patient outcomes. This hypothesis is being tested in the Phase Ib/II ELONA trial (Phase Ib commenced in Q422), which is a proof -of-concept study to evaluate the efficacy and tolerability of ONA-XR + elacestrant combination treatment in patients who have progressed on first-line anti-estrogen + CDK4/6 inhibitor therapy. Notably, atleast 50% of the selected patient population will carry the ESR1 mutation which, in light of the recent FDA approval, seems to be a sensible move, in our opinion. The Phase Ib dose-escalation portion will evaluate four cohorts of ONA-XR plus elacestrant and Phase II will evaluate up to 45 patients. The primary endpoint will be objective response rate, while PFS and clinical benefit rate will be secondary endpoints. Initial data from the Phase Ib study are expected in Q423. If positive, the results should create significant market opportunity for Context.
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Research: TMT
SenSen Networks (SNS) maintained its streak of record year-on-year cash receipts in Q223, with customer receipts up 70% against Q222 to A$2.6m. SNS continues to see growth across its key verticals of smart cities, gaming, retail and surveillance, boosting annual recurring revenues (ARR) to c A$8m, and leaving the company well on track to meet management’s expected ARR of A$10m by the end of FY23. SNS’s operational restructuring and previously announced A$2.5m in cost saving efforts should support management’s goal of cash flow neutrality by the end of the fiscal year. These results lead us to maintain our forecasts and if SenSen can continue to grow ARR, then the valuation gap between peers can potentially close.
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