Alligator Bioscience Q1 2024: The Next Catalyst Will Be the 18-month Readout

Research Update

2024-05-07

07:05

Redeye comments on Alligator Bioscience's Q1 report, including the sub-optimal funding situation after the rights issue and upcoming catalysts, in particular the 18-month OPTIMIZE-1 readout.

RR

Richard Ramanius

Contents

Investment thesis

Quality Rating

Discussion

Financial Results

Valuation

Financials

Rating definitions

The team

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Rights issue prolongs runway into Q3

The rights issue of SEK150m was subscribed to c70%, resulting in gross proceeds of cSEK107m with financial costs of cSEK10m, or almost SEK100m net. This is a strong result considering the share traded below the strike price, but it is less than the company needed. We do not expect the cash position will fund the company until the subscription period of TO9 in December, which were included in the rights issue, so the company will need to either strike a deal or find another source of funding before this. Our pro-forma balance sheet has a cash position of SEK78m after the rights issue. This means Q2 should be funded but most likely not the entirety of Q3 this year.

Orion & Aptevo

In March, Alligator reported a positive interim readout from the phase I study of ALG.APV-527, with three out of six dose cohorts completed. The topline readout is expected in Q4 2024. Positive results could set the project up for partnering discussions. ALG.APV-527 is a joint venture with Aptevo Therapeutics, so if no partner is found, the costs for a phase II study could be divided by the companies if it is decided to go forward. In April, Orion excercised its option to develop the second bispecific antibody leading to a minor milestone payment. It is the second such antibody succesfully developed with Orion.

Base case SEK2.3

The rights issue did not raise all the money the company needed, so we judge it is not unlikely that additional funds will have to be raised before a potential deal for mitazalimab can be signed. We have therefore included a capital issue in our model. We have also removed ATOR-1017 from the base case together with some other minor changes. The additional dilution, in particular, has some impact on our base case which is SEK2.3 (SEK3.1). The cash position can fund the company past the 18-month readout of OPTIMIZE-1 in late June 2024, which will likely be important for landing a deal. By then, the survival data (PFS and OS) will be more mature and could potentially have improved further. It might be strategic to wait with the funding until then.

Key financials

SEKm202220232024e2025e2026e
Revenues36.861.9621.8161.574.6
Revenue Growth153%68.0%904%-74.0%-53.8%
EBITDA-184.3-238.5370.629.3-58.8
EBIT-193.0-249.0370.629.3-58.8
EBIT Margin-524%-402%59.6%18.1%-78.9%
Net Income-193.4-248.6358.129.3-58.8
EV/Sales6.66.30.00.00.9
EV/EBIT-1.3-1.60.0-0.2-1.1

Investment thesis

Case

An outlicensing deal can unlock value and move the share

Alligator's main asset is mitazalimab, a CD40 agonist activating the immune system. It is being investigated in a phase II trial in pancreatic cancer with positive topline results in January 2024 and a new readout scheduled for mid-2024. Alligator now seeks a pharma partner for a pivotal phase III trial and a parallel phase II trial in bladder cancer. Alligator’s next-generation CD40 platform technology, Neo-X-Prime, which is similar to a patient-specific vaccine, is also based on CD40. The first project, ATOR-4066, is almost ready for preclinical studies. This provides follow-up potential. The business case hinges on Alligator finding a partner for mitazalimab in the short term, which would likely move the share towards the base case and potentially the bull case. Strengthened data from the upcoming readout increases the probability of finding a partner.

Evidence

Phase I and phase II data support mitazalimab

Mitazalimab has substantial data from a phase I trial with 95 patients. In the readout of the ongoing phase II trial in combination with FOLFIRINOX (n=57) in January 2024, the ORR was 40% (with an unconfirmed rate of 51%), compared to FOLFIRINOX alone with 32% in its pivotal trial. The most impressive result was the median duration of response of 12.5 months (5.9 for FOLFIRINOX). This suggests mitazalimab potentiates FOLFIRINOX.

Supportive Analysis

Alligator also has another active trial, ALG.APV-527 in phase I since Q1 2023 in a joint venture with Aptevo Therapeutics with the topline readout in Q4 2024. Alligator also has its own antibody libraries (GOLD and FAB), an optimization technology (FIND) and a unique bispecific platform (RUBY) that can generate research deals. It has an agreement with Orion (up to EUR 469m in milestones), and Biotheus (up to USD 142m in milestones). It owns 35% of a HER2 licensing deal with Henlius.

Challenge

Mitazalimab and other projects need a partner

Alligator intends to continue the development in pancreatic cancer with a pivotal trial, with around 500-800 patients needed. Such a trial would cost around SEK1bn and has to be funded by a partner. An alternative might be to conduct a somewhat smaller phase IIb trial (perhaps one that could be expanded into a phase III trial), with potential for an accelerated approval upon strong results, but this would not be ideal. ATOR-1017 also needs partnering or funding.

Challenge

Additional funding or a deal

Alligator's pro-forma cash position is cSEK80m. This should last into Q3 this year. This means additional funding will likely be needed before mitazalimab could be out-licensed, though a deal could materialise at any point in time.

Valuation

Valuation assumes deal in 2024

Our Base Case of SEK 2.3 assumes an outlicensing of mitazalimab in 2024 (with an upfront of USD75m and total deal value of USD800m), using a WACC of 15% and some dilution from the raising of cSEK140m. The valuation range is SEK1.0-SEK5.1.

Quality Rating

People: 3

Søren Bregenholt is CEO of the company. He has worked in the industry for more than 20 years, half of that time at Novo Nordisk. The partly new, skilled management and proficient board are complemented by a skilled workforce, a large part of which hold a PhD degree. The main shareholder, Allegro, has a chair on the board, where it has a major influence and has brought more financial stability to the company (as through the recent bridge loan). 

Business: 3

Pharmaceuticals is a high-margin industry in which there is clear product protection for companies' projects through patents. It is generally a non-cyclical industry. For research companies like Alligator, 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

After raising cSEK100m in April 2024, Alligator currently has a cash position of circa SEK80m. Unless a deal with mitazalimab can be negotiated in the next few months, additional funding will be needed before the end of Q3 this year. 

Discussion

Considering no deal has been signed yet for mitazalimab, we believe potential partners may be waiting for the mid-year readout, which will provide more mature progression-free and overall survival data. The data presented in January was quite early. This readout will therefore likely be important. We would like to see further improved PFS and OS data. ORR and duration of response data are already mature and convincing, but investors and partners may want to be more certain they translate into improved survival. The next readout is scheduled for late June 2024.

Another important milestones will be the full recruitment of the 450 micro-g/kg cohort (n=15) in OPTIMIZE-1, which is expected by Q3, with a readout in Q1 2025. This study is more focused on pharmacokinetics and pharmacodynamics than efficacy. The phase III study is then planned to start in H1 2025.

ALG.APV-527 is on track for a topline readout in the phase I study in Q4 2024. Furthermore, AC101 (out-licensed to Henlius), which is being developed in gastric cancer in Asia, should complete the phase II study (n=150) later this year.

Financial Results

Alligator had income of SEK7m classified as reimbursement for development work, which is likely due to the Orion collaboration. As both antibody programmes have now been handed over to Orion, we expect quarterly income to decrease, as should costs.

Sales, Light

Revenues

Operating costs decreased compared to the previous four quarters and amounted to SEK-67m. As we mentioned in our last update, the company had built up a deficit in working capital. This led to a negative cash flow effect of SEK-25m in Q1, with an operating and lease amortisation cash flow of SEK-85m in Q1. Alligator obtained a loan of SEK59m from the main owners in Q1, which has been converted into shares after the rights issue, from which the company obtained around net SEK97m. This leaves the company with a cash position of circa SEK78m.

Even with the cost reduction programme of cSEK5m per quarter implemented and assuming operating costs (and a similar cash flow) of cSEK60m or less per quarter, the cash position will only last into Q3 this year. A new rights issue so close after the last one would likely have to be underwritten (using a guarantor consortium) at a significantly lower price, so another solution would be preferable (e.g. a directed share issue). The ideal would solution would obviously be a deal.

OPEX, Light

Operating costs

Valuation

We have decided to include some dilution in our base case like before. Alligator's rights issue was worth up to SEK150m+100m, but it was not fully subscribed, leading to less dilution and less cash available. We therefore assume additional dilution at the amount not subscribed for (cSEK140m) with a typical discount in order to maintain consistency in our valuation model. The company might strike a deal before this, which is reflected in our bull case where we do not assume any further dilution. TO9 should also lead to some dilution, but the discount is only 10% based on trading in November, for which reason we have not taken it into account in this update.

We have reconsidered our valuation of Neo-X-Prime/ATOR-4066 and increased the upfront payment to USD75m (USD30m), since the valuation assumption is the entire platform, which would consist of several antibodies, could be outlicensed after a first clinical study in humans finishes around 2028. The total deal value is still USD1000m. Our previous estimates were too conservative for a platform technology.

We have added two years to the ORION programme. Our original timeline was optimistic. This has a minor impact, decreasing the valuation by cSEK40m.

Since ATOR-1017 has been paused and we see no obvious way forward in the short term, we have removed it from our base case, including it only in the bull case. Furthermore, we have lowered our estimates, since we believe the focus is on the bispecific ALG.APV-527 (developed together with Aptevo Therapeutics), which is a more attractive asset. We have halved the total deal value and upfront payment to USD300m and USD10m, respectively; we have also reduced the peak sales estimate to USD800m (USD900m). This reduces the value by cSEK120m in the bull case.

Sum-of-the-parts
ProgrammeTargetIndicationPhaseLOARoyaltyPeak SalesMarketNPV
(MUSD)(SEKm)*
MitazalimabCD40PDACII25%15%14002028
Mitazalimab IICD40BladderI8%15%60020302490
ALG.APV-5274-1BB/5T4Head & NeckI6%13%10002031169
ATOR-10174-1BBBreastII ready9%13%80020310
Neo-X-Prime/ATOR-4066CD40/XmCRCDiscovery3%12%26002034209
Henlius, Biotheus, Orion2-13%8%700-15002027-288
Technology (SEKm)3155
Net Cash78
Overhead, incl. taxes (MSEK)-978
Fair Value (MSEK)2255
No. Shares (mil.)759
Fair Value per Share (SEKm)3.0
Equity issue (SEKm)140
Fully Diluted Fair Value per Share (SEKm)2.3
*The valuation is based on a conversion rate of USD/SEK 10.5 and WACC of 15%.

Our bull case is SEK5.1 and our bear case is SEK1.0. In our bull case, we assume Alligator finds a partner for mitazalimab before Q3 with the same conditions as in our base case, leading to no dilution. We also set the LOA to 36% and lower the WACC to 13%. In our bear case, we have also removed ALG.APV-527. We have assumed Alligator has to raise another SEK250m early next year to fund the continued development of mitazalimab, though we have not changed the time plan for the market launch. We also assume worse deal conditions, a total deal value of USD600m with an upfront of USD35m and royalties of 13%.

Financials

Income statement
SEKm20232024e2025e2026e
Revenues61.9621.8161.574.6
Cost of Revenue0.000.000.000.00
Operating Expenses300.4251.2132.2133.4
EBITDA-238.5370.629.3-58.8
Depreciation10.52.50.000.00
Amortizations0.000.000.000.00
EBIT-249.0370.629.3-58.8
Shares in Associates0.000.000.000.00
Interest Expenses1.414.50.000.00
Net Financial Items0.40-12.50.000.00
EBT-248.6358.129.3-58.8
Income Tax Expenses0.000.000.000.00
Net Income-248.6358.129.3-58.8
Balance sheet
Assets
Non-current assets
SEKm20232024e2025e2026e
Property, Plant and Equipment (Net)2.70.140.140.14
Goodwill0.000.000.000.00
Intangible Assets18.018.018.018.0
Right-of-Use Assets17.617.617.617.6
Other Non-Current Assets2.06.06.05.3
Total Non-Current Assets40.241.741.741.0
Current assets
SEKm20232024e2025e2026e
Inventories0.000.000.000.00
Accounts Receivable0.0049.712.96.0
Other Current Assets12.118.74.82.2
Cash Equivalents66.1650.4652.1580.4
Total Current Assets78.2718.8669.9588.6
Total Assets118.4760.5711.6629.6
Equity and Liabilities
Equity
SEKm20232024e2025e2026e
Non Controlling Interest0.000.000.000.00
Shareholder's Equity11.9370.0399.3340.4
Non-current liabilities
SEKm20232024e2025e2026e
Long Term Debt0.000.000.000.00
Long Term Lease Liabilities7.57.57.57.5
Other Non-Current Lease Liabilities0.000.000.000.00
Total Non-Current Liabilities7.57.57.57.5
Current liabilities
SEKm20232024e2025e2026e
Short Term Debt0.000.000.000.00
Short Term Lease Liabilities8.68.68.68.6
Accounts Payable21.374.619.49.0
Other Current Liabilities69.272.265.261.9
Total Current Liabilities99.1155.393.279.5
Total Liabilities and Equity118.5532.8500.0427.4
Cash flow
SEKm20232024e2025e2026e
Operating Cash Flow-189.3373.110.9-62.3
Investing Cash Flow-2.50.000.000.00
Financing Cash Flow161.6211.2-9.2-9.4

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Contents

Investment thesis

Quality Rating

Discussion

Financial Results

Valuation

Financials

Rating definitions

The team

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