Curasight Q1: Moving forward

Research Update

2024-05-27

08:57

Redeye updates its view of Curasight following the Q1 report and recent events in the company.

FT

Fredrik Thor

Contents

Q1 review

Valuation

Investment thesis

Quality Rating

Financials

Rating definitions

The team

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No surprises

The report in itself was no surprise as the operating loss was in line with expectations at DKK9.4m, and the cash position amounted to DKK11.9m at the end of the quarter. The company also mentions in the report that it has received the milestone payment announced in January relating to GMP manufacturing (USD0.5m), which would be roughly DKK3.5m. However, this is not fully disclosed in the report.

Announced accelerated strategy

During the quarter, Curasight announced a strategy to accelerate its therapeutic platform through a phase I/IIa basket trial in five indications (brain cancer, neuroendocrine tumors, head and neck cancer, non-small cell lung cancer, and pancreatic cancer) expected to start in 2025. We see this as a promising approach, but it would require additional capital.

Some adjustments

We previously assumed a rights issue of DKK75m (at DKK12.5 per share). Following the share price development and Curasight's intended sum in the canceled rights issue, we make some adjustments (assume Curasight will raise DKK50m but at a lower price (DKK6 per share). We also lower our OPEX assumptions as the company has guided that its basket study will be initiated in 2025. As a result, we adjust our base case to DKK27 (29) per share.

Key financials

DKKm202220232024e2025e
Revenues0.000.007.042.9
EBIT-19.0-33.2-38.2-14.1
Net Income-18.3-26.2-38.2-14.1

Q1 review

  • Operating loss amounted to DKK-9.4 (-6.2m)
  • Cash and cash equivalents at the end of the quarter amounted to DKK11.9m (44m)

(The numbers in parenthesis refer to the corresponding quarter of last year)

No material news in Q1 report

The report in itself was no surprise as the operating loss was in line with expectations at DKK9.4m, and the cash position amounted to DKK11.9m at the end of the quarter. The report also mentions that it received the milestone payment announced in January relating to GMP manufacturing (USD 0.5m), which would be roughly DKK3.5m. However, this is not fully disclosed in the report.

During the quarter, Curasight announced a strategy to accelerate its therapeutic platform through a phase I/IIa basket trial in five indications (brain cancer, neuroendocrine tumors, head and neck cancer, non-small cell lung cancer, and pancreatic cancer) expected to start in 2025. We see this as a promising approach, also as the company more clearly evaluates the theranostics approach (uTREAT and UTRACE) with this approach. As the broad therapeutic potential of targeting uPAR is one of Curasight's key competitive advantages, it makes sense to evaluate uTREAT in several indications in one trial (basket) to maximize value. Still, the next step after this trial will likely be dependent on a partner.

In relation to the announced strategy, Curasight also announced its intention to raise up to DKK51.2m in a rights issue, which was later canceled due to low interest (in part since the share price fell below the subscription price). The company mentions in its report that it expects "to be able to announce additional funding to the market soon with the effort to accelerate our clinical pipeline and continue to ensure value creation for our shareholders and at the same time contribute meaningfully to cancer treatment for patients in need."). We will return more to the uTREAT program but would like to learn more about the financing solution first.

In the report, the company mentions that it expects to start the phase IIb trial with uTRACE in prostate cancer in H1 2024 (it has already been approved) and receive a milestone payment from Curium in relation to the 1st treated patient. We don't yet know the extent of this payment, but we would guess that it is at least on par with the payment in relation to GMP manufacturing, which should somewhat boost the company's cash position. Still, we expect the cash runway to extend into Q3, which is not far away, but we would expect an announced solution earlier. We assume a rights issue in our base case, but an amended deal with Curium or another agreement/soft funding could also be a positive solution.

Financing and OPEX (White)

Valuation

In the previously announced rights issue, the company opted to raise up to DKK51.2m, and we had previously assumed a rights issue of DKK75m (at DKK12.5 per share). Following the share price development and Curasight's intended sum, we make some adjustments (assume Curasight will raise DKK50m but at a lower price (DKK6 per share). We also lower our OPEX assumptions as the company has guided that its basket study will be initiated in 2025. As a result, we adjust our base case to DKK27 (29) per share.

AssetIndicationLoARoyaltiesPeak sales (USDm)Est. launchDeal size USDmrNPV (DKKm)
uTRACE BrainBrain Cancer33%20%137202770147
uTRACE ProstateProstate Cancer31%15%564202670304
uTRACE NETsNeuroendocrine Tumors31%20%99202870102
uTRACE Head & NeckHead and Neck Cancer31%20%181202870148
uTREAT GlioblastomaGlioblastoma5%15%941203135098
Technology value (DKKm)799
Net cash* (DKKm56
Shared costs** (DKKm)-87
Fair value (DKKm)767
Shares outstanding (million)20
Diluted shares outstanding (million)28
Equity value per share (DKK)27

** Includes assumed rights issue

Investment thesis

Case

Theranostics platform with broad potential

The case in Curasight centres around the broad potential in the company’s theranostics (therapy + diagnostics) platform, currently being tested in four cancer indications, mainly through cost-effective investigator-initiated clinical trials – something we argue has not yet been fully priced into the share price. Unlike most platforms, Curasight’s target, uPAR, is not bound to a specific form of cancer, making it a versatile target to build a PET-imaging (positron emissions tomography) and targeted radiotherapy (radioligand) platform around. This rapidly growing market is expected to reach USD35bn by 2031 according to our research, further strengthened by increased deal activity in recent years. We see multiple inflection points ahead, most notably clinical progress and study start in the partnered indication of prostate cancer (uTRACE) during H1 2024e, and more information and trial initiation of the first clinical trial its targeted radioligand therapy in 2024e/2025e (uTREAT), as well as a financing solution (soon).

Evidence

uPAR biomarker a predictor of cancer severity

Several clinical and preclinical studies have shown that a high concentration of uPAR is associated with a worse survival outcome. Consequently, it forms a strong foundation for Curasight’s mid-staged PET imaging diagnostic agent (uTRACE), which acts as a diagnostics tool, in the hope of increasing accuracy and individualizing therapy, and as a selection tool for the targeted radioligand therapy uTREAT, which uses the same foundation with the addition of radiation that acts locally where uPAR is found. This latter, currently in preclinical development, is believed to be a more harmless form of radiation therapy. From a market perspective, deal activity in the field has increased significantly and the underlying market is expected to reach USD31bn by 2031 according to our research. We further argue that Curasight’s approach has been validated by its recent deal (worth some USD70m) with uTRACE in prostate cancer with Curium, a leading company in the field.

Supportive Analysis

The aim in one of several clinical studies investigating uTRACE (n=27) was to investigate the correlation between the uptake of the PET tracer uTRACE, which targets the urokinase-type plasminogen activator receptor (uPAR), and the Gleason score in patients undergoing prostate biopsy. The study cohort comprised patients with clinical suspicion of prostate cancer (PCa) or those previously diagnosed with PCa. The patients were subjected to a combination of uPAR PET and multiparametric MRI (mpMRI). The standardised uptake value (SUV) in the primary tumour was measured by two independent readers. The study found a statistically significant positive correlation between the maximum SUV (SUVmax) and the Gleason score (Spearman ρ = 0.55; P = 0.003). Furthermore, in an exploratory part of the study, the researchers established a cut-off for the tumour SUVmax that could accurately discriminate a Gleason score of ≥3+4 from a Gleason score of ≤3+3 with a sensitivity of 96% and a specificity of 75%. To distinguish a Gleason score of ≥4+3 from a Gleason score of ≤3+4, a cut-off was established with a sensitivity of 93% and a specificity of 62%. The paper concluded that uPAR PET/MRI with uTRACE could potentially serve as a promising non-invasive method for the evaluation of PCa, potentially mitigating the need for repeated biopsies, as utilised in active surveillance.

Challenge

Capital injection needed for ambitious strategy

We judge that the company’s cash runway extends into Q3. . We assume a capital injection of DKK50m, but we must highlight that the company's ambitious agenda will require further capital unless it sees a sizeable upfront payment from a licensing partner in 2024/2025. Curasight has a strong foundation with investigator-initiated trials, and it has prioritised four indications (brain cancer, prostate cancer, neuroendocrine tumours, and head and neck cancer). While this is a strength, we consider Curasight to undercapitalised to fully take advantage of all these opportunities at the moment.

Challenge

Commercialization of uTRACE

Unlike with a novel therapy (including uTREAT), it can be trickier to launch a new diagnostics agent, given the rigidity in guidelines and the slow adoption amongst physicians. While the bar for approval can be lower, we believe it is especially important to have a strong partner with a clear understanding of the market dynamics for a successful commercial launch. We believe the collaboration with Curium has strengthened Curasight’s position in prostate cancer significantly, and we hope to see Curasight securing relevant partnerships for its other indications as well.

Valuation

Broad potential not yet mirrored in valuation

We base our valuation of Curasight on a DCF model of its current pipeline where we apply a WACC of 15% and an estimate period between 2023e-2040e. We initiate coverage with a base case of DKK27 per share, with respective bull and bear cases of DKK60 and DKK2. We anticipate multiple inflection points ahead, mainly relating to clinical progress with uTRACE and uTREAT as well as also a financing solution, which could transform the company further, if successful.

Quality Rating

Summary Redeye Ratings

The rating consists of three valuation keys, each consituting an overall assesment of several factors that are rated on a scale of 0 to 1 points. The maximum score for a valuation key is 5 points.

People: 3

The company boasts a well-assembled team that merges the management and private equity expertise of CEO/CFO
Ulrich Krasilnikoff (including experience from Capidea) with the strong scientific foundation of its co-founders. Among
them, Andreas Kjær is prominent, serving as the CSO/CMO and a board member. Furthermore, insiders hold some
70% of the capital, which is quite unusual for a biotech company at this stage and clearly shows their “skin in the
game”

Business: 3

Curasight, having not yet generated any revenues, has no established position in the market. However, success in the
development and commercialization of uTRACE and uTREAT could provide the company with strong protective
barriers surrounding its business, protected by patents and rigid guidelines, ensuring stability. Furthermore, we
estimate that Curasight will out-license its project and thus see an asset-light business model with the potential for
high profitability

Financials: 0

Curasight is a pre-revenue biotech company that has not historically achieved profitability, and it anticipates a need
for capital in the relatively near term.

Financials

Income statement
DKKm20232024e2025e
Revenues0.007.042.9
Cost of Revenue0.000.000.00
Operating Expenses32.145.257.0
EBITDA-32.1-38.2-14.1
Depreciation1.10.000.00
Amortizations0.000.000.00
EBIT-33.2-38.2-14.1
Shares in Associates0.000.000.00
Interest Expenses0.000.000.00
Net Financial Items0.000.000.00
EBT-33.2-38.2-14.1
Income Tax Expenses-7.10.000.00
Net Income-26.2-38.2-14.1

Rating definitions

The team

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Contents

Q1 review

Valuation

Investment thesis

Quality Rating

Financials

Rating definitions

The team

Download article