Active Biotech Q1 2024: Approching Naptumomab Topline Data in Lung Cancer

Research Update

2024-05-13

13:45

Analyst Q&A

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Richard Ramanius answered 2 questions.

Redeye provides its view of Active Biotech's first quarter report of 2024.

RR

Richard Ramanius

Contents

Investment thesis

Quality Rating

Outlook

Financial Results

Valuation

Financials

Rating definitions

The team

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Biodistribution study with laquinimod eye drops started

In April, the investigator-sponsored phase I study of laquinimod began enrollment with results expected in H2 2024. The goal is to demonstrate laquinimod reaches the posterior parts of the eye. Positive results will set laquinimod up for a phase II study and potentially a partner deal. It is the asset closest to realising value.

Laquinimod & naptumomab

The two trials in myelofibrosis are about to start, the US one conducted by MD Anderson in Q2 and the EU one by Oncode Institute and the HOVON network in Q3. The investigator-sponsored trial in multiple myeloma, which began in 2020, is expected to finish this year. It will not be a major catalyst, as multiple myeloma is no longer in focus, but the data generated might be utilised in the myelofibrosis programme. The readout from naptumomab's phase IIa study in lung cancer is expected around the middle of this year and is the closest share catalyst. Strong results could potentially enable the programme to proceed to a phase III study (though we judge an initial dose-finding part might be required), which would have to be conducted in partnership with a third party. A sub-licensing agreement is essential to unlock the full value of naptumomab. The principal value for Active Biotech lies in the favourable royalty rate (with the current agreement).

Base Case SEK1.5

We assume additional funds will be needed to fund operations later this year, so we have included some dilution to our DCF valuation. We have also added one year to the naptumomab programme, now with a launch in 2030 (2029). This renders a new diluted base case of SEK1.5 (SEK1.9).

Key financials

SEKm202220232024e2025e2026e
Revenues0.000.000.0015.647.9
Revenue Growthnm.nm.nm.nm.206%
EBITDA-57.9-46.5-43.0-35.37.8
EBIT-57.9-46.5-43.0-35.37.8
EBIT Marginnm.nm.nm.-226%16.4%
Net Income-58.4-45.8-42.8-35.37.8
EV/Salesnm.nm.nm.17.25.5
EV/EBIT-3.2-2.8-5.5-7.633.3

Investment thesis

Case

Readouts from collaborations will drive the share

The main focus now is the two phase II studies with tasquinimod in myelofibrosis, TasqForce funded by the Oncode Institute in Europe starting in Q3 2024, the other in the US funded by MD Anderson starting in Q2 2024, with minor contributions from Active Biotech. Myelofibrosis is a rare disease with a high unmet need, with no disease-modifying treatments. It is commercially attractive, as proven in two recent deals with late-stage myelofibrosis companies valued at USD1.7-1.9bn. Strong results might set the stage for a licensing deal in the upcoming years. After the biodistribution study, a licensing deal for laquinimod is possible even earlier in 2025. The third candidate, naptumomab, a cancer drug, is outlicensed to NeoTX in a deal worth up to USD 71m with favourable royalty rates. Two clinical trials are ongoing. The topline from the a phase IIa trial in NSCLC in combination with docetaxel (a chemotherapy) in early 2024 is the closest share catalyst.

Evidence

Repurposed, well-studied compounds reduce risks

A major strength of Active Biotech over similar companies has been its ability to obtain external financing, or licensing deals, for its projects, leading to substantially lower costs than would otherwise be expected. The second main strength is the fact that the projects have previously undergone unsuccessful phase III trials, but have demonstrated some level of clinical efficacy. Data from previous trials come from several hundred to more than a thousand patients, which can be referenced. Tasquinimod has shown disease-modifying properties in preclinical studies in myelofibrosis. It is also being tested in an externally funded phase I/IIa trial in multiple myeloma in the US, demonstrating safety and some level of clinical activity. Laquinimod, developed for inflammatory eye diseases, has a new eye drop formulation that was proven safe in a phase I trial in early 2023.

Supportive Analysis

There are positive early signals from Naptumomab; in combination with durvalumab it demonstrated a disease control rate of 19% and ORR of 9.5% in 42 heavily pre-treated patients not expected to respond. In the phase IIa trial of naptumomab+docetaxel, at least two out of ten patients responded in the interim futility analysis which could thus continue recruitment (n=35).

Challenge

More funding needed

Active Biotech likely needs additional funding before it can begin to earn money through licensing deals or milestones from NeoTX.

Challenge

Delays

The development of tasquinimod has taken longer than originally expected, both in multiple myeloma and myelofibrosis. Delays increase costs, leave time for competitors and leads to the loss of patent protected years of sales.

Valuation

Base case could be reached with strong readouts followed by deals

Our Base Case is SEK1.5 and includes the valuation of three projects using a WACC of 15%. We assume a licensing deal for laquinimod in 2025 worth USD125m with USD2.5m in upfront and 15% royalties; for tasquinimod we assume a licensing in 2026 deal worth USD650m with USD40m in upfront and 10% in royalties. Our bull case is SEK2.6 and our bear case SEK0.7 (which assumes failure of tasquinimod).

Quality Rating

People: 3

Management consists of a small, experienced team with extensive experience in clinical and business development. The CEO was previously Chief Scientific Officer at the company and led the research and clinical development of Active Biotech’s projects in neurodegenerative diseases and cancer. The board brings extensive and relevant international bio-pharma experience. The company has strong institutional backing, with institutions controlling around 50% of the shares, Mats Arnhög being the main holder with 28% and Peter Thelin number two with 7%; they have has supported the company in previous rights issues.

Business: 3

Active Biotech is an early to mid stage clinical-stage biotech company, developing first-in-class treatments in oncology and inflammatory eye disorders. Current commercial and academic partnerships enable low-cost development of tasquinimod (myelofibrosis), laquinimod (uveitis) and naptumomab (solid tumors).

Financials: 0

Active Biotech has never generated any income from product sales and has not been profitable on an annual basis since 2001. It raised SEK45m to fund operations in 2023. It raised another SEK42m in late 2023 to fund the company through most of 2024. Another funding round in 2024 will be needed before the most probable next value creating step, a potential outlicensing of laquinimod.

Outlook

We commented on the start of laquinimod's biodistribution study in a note.

Large investments are being made in myelofibrosis. A new transaction is about to take place after the EUR2.7bn cash bid from Novartis to acquire MorphoSys AG in February 2024. The main asset is elabresib, a late-stage BET inhibitor for myelofibrosis (MF). It is about to file for approval in the US as a first-line treatment in combination with ruxolitinib after a successful phase III study. This further underlines the attractiveness of the indication, which is likely underdiagnosed and under-served by current treatments and therefore of interest for pharmaceutical companies.

We have previously mentioned SOBI's acquisition of CTI Biopharma for USD1.7bn, the main asset being JAK2 inhibior Vonjo (pacritinib), approved in 2022 in the US for myelofibrosis patients with severe thrombocytopenia. We have also mentioned momelotinib, a JAK1/JAK2 inhibitor for myelofibrosis, purchased by GSK through the acquisition of Sierra Oncoloy in 2022 for a total consideration of USD1.9bn.

An important work that has been accomplished up until 2023 is the strengthening of the patent portfolio, as discussed in the 2023 annual report. The substance patents' of Active Biotech's candidates have expired. New patents and patent applications valid until 2041-2042 are now in place protecting tasquinimod for use in myelofibrosis, multiple myeloma and myelodysplastic syndrome. Tasquinimod already has orphan drug designation in multiple myeloma and myelofibrosis. Several new patent applications protecting naptumomab and laquinimod until 2040-2042 have also been submitted (by NeoTX for naptumomab). This means the IP situtation has been significantly improved since Active Biotech refocused its strategy to hematology for tasquinimod and ophthalmology (eye disease) for laquinimod, which is important for business development.

Financial Results

Operating costs (SEK-11m) were in line with previous quarters. The cash position of SEK25m should fund slightly more than two more quarters.

Chart 1

Operating costs

Valuation

NeoTX is located in Israel, whose economy and business environment has been negatively affected by the ongoing war. This impacts NeoTX' ability to refinance negatively. The second a phase IIa study, in combination with durvalumab, needs additional funding for the esophageal cohort, while the study in combination with pembrolizumab has been canceled. It is likely the development of naptumomab will experience delays. We have again added one year to the development programme with an estimated potential commercial launch in 2030.

The current cash position will not fund the company through the rest of 2024 (only around two more quarters). We have therefore added dilution by assuming an equity issue this year at a certain discount with net SEK45m being obtained, similar to the funding rounds in 2022 and 2023. Our new bear case is SEK0.7 (1.0) while our new bull case is SEK2.6 (3.5).

Sum-of-the-parts ValuationColumn2Column3Column4Column5Column6
ProgrammeIndicationPeak Sales (USDm)LOARoyaltyLaunchrNPV (SEKm)
TasquinimodMyelofibrosis60014%10%2030354
NaptumomabSolid tumors55011%17%2030190
LaquinimodOphthalmology32019%15%2029277
Total1470821
Shared costs, incl. taxes-172
Net cash25
Total674
Shares outstanding 362
Value per share1.9
Equity Issue, net45
Fully diluted base case1.5
Source: Redeye Research, USD/SEK=10.5, WACC=15%

Financials

Income statement
SEKm20232024e2025e2026e
Revenues0.000.0015.647.9
Cost of Revenue0.000.000.000.00
Operating Expenses46.543.051.040.0
EBITDA-46.5-43.0-35.37.8
Depreciation0.000.000.000.00
Amortizations0.000.000.000.00
EBIT-46.5-43.0-35.37.8
Shares in Associates0.000.000.000.00
Interest Expenses0.000.000.000.00
Net Financial Items0.700.200.000.00
EBT-45.8-42.8-35.37.8
Income Tax Expenses0.000.000.000.00
Net Income-45.8-42.8-35.37.8
Balance sheet
Assets
Non-current assets
SEKm20232024e2025e2026e
Property, Plant and Equipment (Net)0.000.000.000.00
Goodwill0.000.000.000.00
Intangible Assets0.250.250.250.25
Right-of-Use Assets4.74.74.74.7
Other Non-Current Assets0.380.380.380.38
Total Non-Current Assets5.35.35.35.3
Current assets
SEKm20232024e2025e2026e
Inventories0.000.000.000.00
Accounts Receivable0.620.001.33.8
Other Current Assets1.90.001.33.8
Cash Equivalents36.2-6.6-41.8-33.6
Total Current Assets38.7-6.6-39.3-26.0
Total Assets44.0-1.3-33.9-20.6
Equity and Liabilities
Equity
SEKm20232024e2025e2026e
Non Controlling Interest0.000.000.000.00
Shareholder's Equity30.7-12.1-47.5-39.6
Non-current liabilities
SEKm20232024e2025e2026e
Long Term Debt0.000.000.000.00
Long Term Lease Liabilities0.000.000.000.00
Other Non-Current Lease Liabilities3.03.03.03.0
Total Non-Current Liabilities3.03.03.03.0
Current liabilities
SEKm20232024e2025e2026e
Short Term Debt1.50.000.000.00
Short Term Lease Liabilities0.000.000.000.00
Accounts Payable0.000.001.95.7
Other Current Liabilities8.88.69.411.0
Total Current Liabilities10.48.611.316.7
Total Liabilities and Equity44.0-0.53-33.2-19.9
Cash flow
SEKm20232024e2025e2026e
Operating Cash Flow-45.7-42.8-35.28.2
Investing Cash Flow0.000.000.000.00
Financing Cash Flow40.20.000.000.00

Rating definitions

The team

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Contents

Investment thesis

Quality Rating

Outlook

Financial Results

Valuation

Financials

Rating definitions

The team

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