Lytix Q2 2023: ATLAS-IT-05 Fully Recruited
Research Update
2023-09-01
07:10
Since our initiating coverage, Verrica presented promising results in BCC. Lytix has recruited the first planned 20 patients in its phase II study in melanoma, while an additional 20 may be added after an interim analysis. Furthermore, a new investigator sponsored trial, ATLAS-IT-06, in neoadjuvant melanoma is planned to start in H1 2024.
Richard Ramanius
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The phase two trial of LTX-315 in BCC sponsored by Verrica consists of two parts. In part one, four out of six patients who received the highest dose had complete tumour clearance, one a 95% reduction and one a 30% reduction. Part two is now recruiting. Based on the positive results, Verrica has decided to accelerate the trial. According to ClinicalTrials, 80 patients will be recruited across parts one and two, with results expected by H1 2024.
All twenty patients in the ATLAS-IT-05 study have now been recruited across ten sites in the US, Norway, France and Spain. A decision on whether to include an additional 20 patients to arrive at a total of 40 will be based on an interim readout this year. A positive new development is the planning of a new investigator-sponsored trial (ATLAS-IT-06) in neoadjuvant melanoma with 27 patients, scheduled for H1 2024. Neoadjuvant treatment is used before resection. This is a similar setting to that of Verrica’s BCC trial, though more serious since melanoma often metastasises. The expenses for Lytix will be small, consisting among other things of clinical material (LTX-315).
Lytix' projects are developing according to plan, with the addition of ATLAS-IT-06 being a positive surprise. The interim readout of ATLAS-IT-05 will be the next major catalyst. We recently initiated coverage with a base case of NOK14, which we restate after the Q2 report.
NOKm | 2020 | 2021 | 2022 | 2023e | 2024e |
Revenues | 6.7 | 25.8 | 17.3 | 0.0 | 8.8 |
Revenue Growth | nm. | 287% | -33.1% | -100% | nm. |
EBITDA | -42.4 | -48.0 | -65.7 | -92.3 | -84.5 |
EBIT | -42.4 | -48.0 | -65.7 | -92.3 | -84.5 |
EBIT Margin | -635% | -186% | -380% | nm. | -961% |
Net Income | -42.1 | -48.0 | -56.0 | -92.3 | -84.5 |
EV/Revenue | - | - | 9.6 | nm. | 42.1 |
EV/EBIT | - | - | -2.5 | -2.5 | -4.4 |
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Investment thesis
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