Cantargia Q1 2024: Notable Cost Reductions

Research Update

2024-05-22

07:00

Redeye comments on Cantargia's Q1 report. The main thing that stands out is the great Q/Q cost reduction. There has also been developments in inflammatory diseases relevant for CAN10.

RR

Richard Ramanius

Contents

Investment thesis

Quality Rating

Discussion

Hidradenitis suppurativa (HS)

Financial Results

Valuation

Financials

Rating definitions

The team

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Market position of CAN10 improving

External events in the first half of 2024 have highlighted the potential of CAN10 in hidradenitis suppurativa. CAN10, under development in autoimmune diseases, is shaping up to become a candidate with a market opportunity on par with nadunolimab. Oncology has become a somewhat less hot space in recent years, even if it is still by far the largest pharma market. Immunology has become more fashionable since Humira lost its patents and as rates of autoimmune diseases continue to rise. We therefore believe CAN10 can be developed as an attractive partnering asset. With phase I data at the end of the year, the path will be open for efficacy studies. The main track has been systemic sclerosis. However, hidradenitis suppurativa (HS) or psoriasis could also be interesting indications with blockbuster potential. Trials would be relatively quick compared to nadunolimab’s, as common endpoints are results after 12 or 16 weeks.

Significantly lower cost base in 2024

As previously communicated, costs decreased in Q1, to around SEK-40m. With a cash position of circa SEK140m, the company is funded for about another year, excluding the planned phase IIb study in pancreatic cancer, past the important H2 readouts in breast cancer (TRIFOUR) and CAN10's phase I study in H2 2024. Discussions are ongoing about funding of the phase IIb study in pancreatic cancer, which cannot begin before this is settled.

Base Case SEK15 (SEK15)

We have removed some cancer indications from the sum-of-the-parts, which has a slightly negative effect on the base case, while the increase in share price since our last update has a positive effect on the assumed funding dilution. These changes counterbalance leading to a restatement of our base case of SEK15.

Key financials

SEKm202220232024e2025e2026e
Revenues0.000.000.00577.50.00
Revenue Growthnm.nm.nm.nm.-100%
EBITDA-381.6-290.0-231.1328.0-155.4
EBIT-381.6-290.0-231.1328.0-155.4
EBIT Marginnm.nm.nm.56.8%nm.
Net Income-371.8-280.0-226.4328.0-155.4
EV/Salesnm.nm.nm.1.2nm.
EV/EBIT-0.2-2.0-4.42.1-5.5

Investment thesis

Case

Two studies, a phase II in breast cancer with nadunolimab and phase I with CAN10 will drive the share short-term

Cantargia's main candidate, nadunolimab (CAN04) which acts on inflammatory pathways, has demonstrated impressive overall response rates in three cancer indications. In particular, it has impressive overall and progression-free survival in pancreatic cancer. The phase II study in triple-negative breast cancer (TRIFOUR, n=100) will have a topline readout in H2 2024. It is the first placebo-controlled study and a major catalyst. Readouts from three other cancer studies will be available in 2024 together with further biomarker and neuropathy results. These studies will drive the share and could potentially set the company up for a licensing deal in cancer by 2025, as placebo-controlled results will finally be available. The phase IIb study in pancreatic cancer is approved and set to start by mid-2024, pending funding, with a topline readout late in 2025 and interim in early 2025 - this lead project will be a major value driver. CAN10 is in a phase I study in inflammatory diseases with up to 80 participants with a topline readout in H2 2024.

Evidence

Results in phase IIa CANFOUR in pancreatic and lung cancer are superior to historical controls

Patients with non-small cell lung cancer (n=30) showed a response of 53% versus 22-28% in historical controls, resulting in a median progression-free survival (PFS) of 6.8 months and median overall survival (OS) of 13.7 months. Furthermore, there were two complete responses. In patients with pancreatic cancer (n=73), long-term responses or pseudoprogression have been observed, resulting in a median PFS of 7.2 months and an OS of 12.9 months vs an OS of 8.5 months in historical controls. IL1RAP-high patients had an OS of 14.2 vs 10.6 for IL1RAP-low showing nadunolimab engages its target. Furthermore, an ORR of 60% was demonstrated in the phase I part of TRIFOUR (n=15), which is twice that of historical figures.

Challenge

Negative placebo controlled clinical outcomes are a risk

Cantargia has not conducted clinical trials with a placebo group. There is a risk that the strong results obtained so far will prove less favorable in controlled conditions.

Challenge

Dilution risk

According to management, the company is funded until early 2025. This means results from the triple-negative breast cancer study could be available before more cash is needed, but Cantargia would need additional cash before a deal can be negotiated. Furthermore, the phase IIb study in pancreatic cancer is not funded. We have included some dilution in our valuation (SEK175m).

Valuation

Low valuation despite convincing results

The tough environment for biotech shares has contributed to a low valuation, as has the delayed development in pancreatic cancer (a pivotal trial was cancelled last year). Our fully diluted Base Case of SEK15 assumes a deal with nadunolimab in 2025, with an upfront of USD 100m, milestones of USD 900m and royalties of 17 percent, with PDAC constituting the most valuable indication. CAN10 in inflammatory diseases also contributes to the valuation. Our valuation range is SEK6-SEK27.

Quality Rating

People: 3

Cantargia is led by an experienced and focused team. CEO Göran Forsberg has been involved in licensing agreements, providing critically important experience that will benefit Cantargia’s future partner negotiations. We believe the board is solidly composed and includes members with different and complementary experience. 

Business: 3

Pharmaceuticals is a high-margin industry in which there is clear product protection via patents for companies' projects. It is generally a non-cyclical industry. For research companies like Cantargia the situation is different, with risks associated not just with clinical development but also with the (cyclical) stock market, where capital requirements are large and often handled via new issues. 

Financials: 0

The liquidity position of circa SEK140m should fund Cantargia through the readout of the phase II breast cancer study (TRIFOUR) in H2 2024 and the phase I trial of CAN10, not taking the phase IIb study in pancreatic cancer (PANFOUR) into account. We do not expect any income before a potential licensing deal, which could be possible in 2025 assuming strong TRIFOUR topline data and strong PANFOUR interim data. 

Discussion

The Q1 report was somewhat uneventful. The cost reduction is important, as it can allow the company to fund operations past the readout in TRIFOUR in H2 2024, the first controlled trial of nadunolimab, with potential of demonstrating better response rates and survival over the control group. This can be a huge value inflection point, as analysts, investors and pharma companies typically value biotech companies with a clear efficacy advantage over placebo higher than companies at an earlier stage, as such data de-risks a project and is easily understandable. The phase IIb results in pancreatic cancer would be an even greater catalyst, but the funding is not yet in place, so there will be some delay to the start (which was planned for mid-2024).

CAN10 approaches a safety phase I readout in 2024. The single ascending and multiple ascending dose parts is recruiting 64 healthy volunteers treated with the IV version. The treatment of the 16 psoriasis patients will begin in Q3 2024 with safety data available within the year from the subcutaneous formulation, which is very useful for further development in autoimmune diseases. Biomarker data will also be communicated, potentially in 2024. We believe there is an opportunity in HS, a disease that has figured in Cantargia's news flow recently and which looks like it could be the next major autoimmune indication.

Hidradenitis suppurativa (HS)

We believe it could make sense to position CAN10 for HS. There is limited competition as of now.There are only two approved drugs, the main one being Humira, versus 12 for psoriasis, which has a similar prevalence. There is probably space for many more drugs. The disease is likely severely underdiagnosed with an estimated 2% global prevalence, with 2 million treated patients in the US. MoonLake (which develops sonelokimab) sees a USD10bn+ market opportunity by 2035.

Several recent developments have occurred in this indication. MoonLake’s sonelokimab and Incyte’s povorcitininb have shown superiority over placebo in phase II studies in 2023-2024, while bimekizumab is on the path towards an FDA approval in 2024 after positive phase III data in 2023. These are IL-17 or JAK1 inhibitors. There has also been recent news in the IL-1 space.

Abbvie’s lutikizumab reported promising results compared to placebo in a phase IIb trial in early 2024. Lutikizumab is a dual variable domain antibody that neutralises both IL-1α and IL-1β . In March, Avalo Therapeutics acquired AVTX-009 for USD15m in stock, USD7.5m in cash, and milestones of up to USD22.5m. The candidate, which neutralises IL-1β, is phase II ready, with topline results from a planned phase II trial in HS expected by 2026. CAN10 (which blocks IL-1, IL-33 and IL-36) should most likely give at least as good results as these in HS, and could consequently be worth more in a deal, assuming the ongoing phase I study concludes successfully.

HS is clearly an up-and-coming indication in which several companies are positioning themselves. It would likely be an attractive space for CAN10, even if it comes some years late to the scene. CAN10 also has potential in psoriasis, systemic sclerosis, atherosclerosis, myocarditis, and many more diseases, too many for Cantargia to develop on its own. This leads us to believe that a licensing deal would have to reflect this potential with large milestones.  

Financial Results

Cantargia had no income except financial income of SEK5m. Costs were much lower than the previous quarter at SEK-42m (SEK-71m in Q4), as previously communicated by management. This is due to the closing of previously open studies with nadunuolimab, leaving mainly TRIFOUR and CAN10's phase I as cost drivers. The operating cash flower was somewhat lower at SEK-55m due to a negative effect from changes in working capital. The liquidity position is SEK143m (SEK195m). The report mentions good prospects of securing financing through e.g. a licensing deal or a share issue.

Chart 1

Cantargia: Operating costs

Valuation

We have removed two indications/programmes from the valuation – CAPAFOUR (FOLFIRINOX in PDAC) and CESTAFOUR (chemotherapy in various indications). Cantargia will prioritise pancreatic cancer, so the further development of these programmes is unlikely in the medium term. They might still provide valuable readouts this year, but we believe it will make sense to let these readouts reflect on the likelihood of approval or peak sales in the main indications (pancreas, lung and breast) rather than maintaining these small indications with an uncertain future. However, we do not change the total assumed deal value (USD1000m). We have also made some changes to cost forecasts, including lower taxes due to lower peak sales, with a positive result on the base case. Our bull case is SEK27 while our bear case is SEK6.

Cantargia sum-of-the-parts valuation
ProgrammeClinical TrialCombinationIndicationLOAPhaseRoyaltyPeak salesLaunchNPVNPV
(USDm)/ share
CAN04/Phase IIb trialGemcitabin/nab-paclitaxelPancreas36%II17%1600202913
nadunolimabCIRIFOURPD-1 inhibitorsNSCLC18%II17%120020295
TRIFOURCarboplatin/gemcitabinTNBC16%I17%50020282
AMLVEN–AZALeukemia (AML)7%I17%70020291
379521
CAN10MonotherapySystemic sclerosis11%I70020306423
Overhead (incl. taxes) (SEKm)-1017-6
EV (SEKm)3421
Net cash (SEKm)1431
Total value (SEKm)356319
Equity issue (SEKm), net175
Fully diluted (SEK)15
Source: Redeye Research, SEK/USD=10.5
CS = cisplatin+gemcitabine

Financials

Income statement
SEKm20232024e2025e2026e
Revenues0.000.00577.50.00
Cost of Revenue0.000.000.000.00
Operating Expenses290.0231.1249.5155.4
EBITDA-290.0-231.1328.0-155.4
Depreciation0.000.000.000.00
Amortizations0.000.000.000.00
EBIT-290.0-231.1328.0-155.4
Shares in Associates0.000.000.000.00
Interest Expenses6.40.310.000.00
Net Financial Items10.04.70.000.00
EBT-280.0-226.4328.0-155.4
Income Tax Expenses0.000.000.000.00
Net Income-280.0-226.4328.0-155.4
Balance sheet
Assets
Non-current assets
SEKm20232024e2025e2026e
Property, Plant and Equipment (Net)4.84.84.84.8
Goodwill0.010.040.040.04
Intangible Assets4.74.74.74.7
Right-of-Use Assets0.000.000.000.00
Other Non-Current Assets0.000.000.000.00
Total Non-Current Assets9.59.59.59.5
Current assets
SEKm20232024e2025e2026e
Inventories0.000.000.000.00
Accounts Receivable2.20.0046.20.00
Other Current Assets17.30.0011.60.00
Cash Equivalents194.7143.3494.4315.9
Total Current Assets214.2143.3552.1315.9
Total Assets223.7152.9561.7325.5
Equity and Liabilities
Equity
SEKm20232024e2025e2026e
Non Controlling Interest0.000.000.000.00
Shareholder's Equity168.7117.3445.3289.9
Non-current liabilities
SEKm20232024e2025e2026e
Long Term Debt0.000.000.000.00
Long Term Lease Liabilities0.000.000.000.00
Other Non-Current Lease Liabilities0.121.71.71.7
Total Non-Current Liabilities0.121.71.71.7
Current liabilities
SEKm20232024e2025e2026e
Short Term Debt0.000.000.000.00
Short Term Lease Liabilities0.000.040.040.04
Accounts Payable23.20.0069.30.00
Other Current Liabilities31.733.845.433.8
Total Current Liabilities54.933.8114.733.8
Total Liabilities and Equity223.7152.9561.7325.4
Cash flow
SEKm20232024e2025e2026e
Operating Cash Flow-286.7-226.4351.1-178.5
Investing Cash Flow0.000.000.000.00
Financing Cash Flow54.7175.00.000.00

Rating definitions

The team

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Contents

Investment thesis

Quality Rating

Discussion

Hidradenitis suppurativa (HS)

Financial Results

Valuation

Financials

Rating definitions

The team

Download article