Trinity Delta Modi-1 successful in first part of Phase I/II trial

Modi-1 successful in first part of Phase I/II trial

Update | 21 February 2023

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Scancell’s Modi-1 has successfully completed the monotherapy arm of the ModiFY Phase I/II trial, generating important results for the Moditope oncology vaccine platform. The first element of ModiFY showed Modi-1 was safe and well tolerated. There were encouraging, albeit early, signals of efficacy despite the advanced disease status of all patients. 23 patients have been treated to date, with 14 patients evaluated; of these 14, one has had a partial response and seven have stable disease. These data are particularly promising and support continuation into the monotherapy expansion phase and, importantly, the initiation of the checkpoint inhibitor (CPI) combination arm. The outcome of combination treatment cohorts will help define Modi-1’s clinical and commercial positioning. These data drive increased confidence in the Moditope platform, leading to an uplift in our rNPV valuation to £300.1m, or 36.7p (from £269.6m, or 32.9p/share previously).

Year-end: April 30	2021	2022	2023E	2024E
Revenues (£m)	0.0	0.0	5.3	0.0
Adj. PBT (£m)	(17.7)	(11.9)	(17.6)	(24.0)
Net Income (£m)	(15.5)	(2.1)	(15.7)	(21.9)
EPS (p)	(2.28)	(0.25)	(1.93)	(2.68)
Cash (£m)	41.1	28.7	17.8	20.2
EBITDA (£m)	(8.6)	(12.6)	(13.8)	(20.2)

Source: Trinity Delta Note: Adjusted numbers exclude exceptionals

Moditope shows early signs of efficacy The Phase I/II Modi-1 study (ModiFY) is a two stage trial. The initial dose escalation and safety phase is followed by a number of specific patient cohorts that explore for signs of efficacy in triple negative breast cancer (TNBC), ovarian cancer, head & neck cancer, and renal cancer as both Modi-1 monotherapy and in combination with checkpoint inhibitors (CPI). A total of up to 138 patients across up to 20 UK sites will be treated, with 23 successfully vaccinated so far. Of these, 14 patients have reached the eight-week evaluation point, with no dose-limiting toxicities or safety concerns seen. Despite having failed at least one round of prior treatment and having progressive disease prior to study enrolment, one patient has a confirmed partial response and seven have stable disease.
Progressing into combination therapy With safety and tolerability confirmed, Modi-1 is progressing into further dose escalation as monotherapy and, importantly, initiating combination therapy with a CPI. It is data from these elements of the study that will provide multiple insights into how and where Modi-1 could be employed. The indications selected are all aggressive and difficult to treat cancers, with clear clinical needs. If the early efficacy signals seen in the first part of ModiFY are confirmed in the latter parts, this would effectively demonstrate Moditope’s mode of action and would further de-risk the programme in our rNPV model.
Raising our valuation to £300.1m, equivalent to 36.7p We explored Scancell’s investment case in detail in our recent February 2023 Outlook. Increasing the probability on Moditope to 12.5% (from 10%) sees our rNPV rise to £300.1m (from £269.6m), or 36.7p/share (30.5p fully diluted). The next 12 to 18 months should see several potential value inflection points, ranging from trial results to further commercial deals. Positive outcomes should boost investor sentiment materially.

Update

21 February 2023


Price	18.00p
Market Cap	£147.3m
Enterprise Value	£124.4m
Shares in issue	818.4m
12 month range	10.5p-29.4p
Free float	54.4%
Primary exchange	AIM London
Other exchanges	N/A
Sector	Healthcare
Company Code	SCLP.L

Corporate client	Yes

Company description

Scancell is a clinical-stage immuno-oncology specialist that has four broadly applicable technology platforms. Two are therapeutic vaccines, Moditope and ImmunoBody, and two are antibody based, GlyMab and AvidiMab.

Analysts

Lala Gregorek
lgregorek@trinitydelta.org
+44 (0) 20 3637 5043

Philippa Gardner
pgardner@trinitydelta.org
+44 20 3637 5042

Exhibit 1: Summary of financials

Source: Scancell, Trinity Delta Note: Adjusted numbers exclude exceptionals.

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