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RNS - Zelluna ASA Reports First Quarter 2025 Financial Results and Provides General Business Update

Company: Zelluna ASA Date: 2025-05-08 Language: English Register to download
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# **First Quarter 2025 Business Update and Financial Results**

*Zelluna ASA, 8 May, 2025*

*Namir Hassan, CEO Hans Vassgård Eid, CFO*

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# Disclaimer

- This presentation has been prepared by Zelluna ASA ("Zelluna" or the "Company") for information purposes only and does not constitute an offer to sell common shares of the Company or a recommendation in relation to the shares of the Company. Neither shall the presentation or any part of it, nor the fact of its distribution or communication, form the basis of, or be relied on in connection with any contract, commitment or investment decision in relation thereto.
- This presentation contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this presentation are forward-looking statements and as such, are based on management's current expectations and beliefs about future events at the date of this presentation. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "hope," "intend," "may," "might," "plan," "potential," "predict," "project," "should," "target," "would" and similar expressions are intended to identify forwardlooking statements, although not all forward-looking statements contain these identifying words.
- Such forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual events, results or achievements to differ materially from the events, results or achievements expressed or implied by the forward-looking statements contained in this presentation. Given these risks,

uncertainties and other factors, recipients of this presentation are cautioned not to place undue reliance on these forward-looking statements.

- The information included in this presentation may be subject to updating, completion, revision and amendment, and such information may change materially. Except as required by law, we are under no duty to update any of these forwardlooking statements after the date of this presentation to conform our prior statements to actual results or revised expectations.
- No representation or warranty (express or implied) is made as to, and no reliance should be placed on, the accuracy, completeness or fairness of the information and opinions contained in this presentation, no reliance should be placed on such information. Neither Zelluna nor any of its owners, affiliates advisors or representatives accept any responsibility, liability or loss whatsoever arising directly or indirectly from the use of this presentation.
- By accepting this presentation, you acknowledge that you are solely responsible for your own assessment of the market and the market position of the Company and that you will conduct your own analysis and be solely responsible for forming your own view of the potential future performance of the Company's business.

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- Key events in Q1 2025
- Zelluna the TCR-NK Technology and Pipeline
- Financial update
- Summary

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# **1 - Key events Q1 2025**

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# Bell Ceremony 4th March 2025 *First ever Cell Therapy company to be listed on the Oslo Stock Exchange*

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#### **Business combination**

- Business combination and private placement of MNOK 51.7 successfully completed on 3 March 2025
- Ultimovacs ASA acquired all shares in Zelluna Immunotherapy AS and changed its name to Zelluna ASA
- Ticker: **ZLNA**
- Requirement for continued listing at the Euronext Oslo Stock Exchange met
	- Reverse share split (share consolidation) 10:1 completed early April 2025

#### **Business integration**

▪ Operational integration of the two legal entities Zelluna ASA and Zelluna Immunotherapy AS completed

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# **Zelluna Reaches Major Milestone:** Manufacturing Process Established in Preparation for Clinical Entry of ZI-MA4-1, its Novel TCR-NK Therapy Targeting Solid Tumours

#### **Manufacturing represents the highest risk activity in preparation for the clinic – now de-risked with this milestone**

- As announced on 22 April 2025, Zelluna has successfully developed, scaled and automated its proprietary manufacturing process for its TCR-NK cell therapies
- This milestone represents a major advancement in the Company's preparation for clinical entry
- The proprietary manufacturing process is applicable to any product emerging from the Company's pipeline which means any TCR-NK product can be plugged into the established manufacturing process strengthening Zelluna's dominance of the TCR-NK therapeutic field
- Based on the established manufacturing process, hundreds of doses could be produced from a single manufacturing batch highlighting scalability and low cost of goods potential

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# Scalable Manufacturing and Patient Access

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**Centralized manufacturing** delivers 100's of cryopreserved doses

Enables treatment of **multiple patients**

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# Key milestones / value inflections

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# Context: Early clinical stage cell therapy companies drive huge value

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- AstraZeneca acquires EsoBiotec: an early Phase I *in vivo* CAR-T company
- Deal triggered after only **1 patient** (myeloma) treated
- Total deal value ~ \$1BN (\$425m upfront, \$575m in milestones)

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- Roche acquires Poseida: an early Phase I "off the shelf" CAR-T company
- Phase I clinical data at point of deal
- Total deal value ~ \$1.5 billion (\$1 billion upfront plus \$0.5 billion milestones)

*November 2024*

*March 2025*

*Zelluna leveraging deals in dialogue and ongoing Business Development activities* 

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# **2 - Zelluna – the TCR-NK Technology and Pipeline**

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**The Challenge**

**The Context**

### **Our Differentiated Solution**

1. Mani, K. et al. Causes of death among people living with metastatic cancer. Nat Com 15, 1519 (2024). <https://doi.org/10.1038/s41467-024-45307-x>

2. Cancer TODAY | IARC Age-Standardized Rate (World) per 100 000, Mortality, Both sexes, in 2022, World, https://gco.iarc.who.int

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# Zelluna developing the next generation of cell therapies

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### **Cell therapies have cured cancer patients**

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### **Nine approvals, mainly in liquid cancer**

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### **Despite successes two key challenges remain:**

1) Solid cancers remain tough to treat and struggle to deliver long term responses

2) Scaling global access to treatment

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**Zelluna has built a platform to take the curative potential of cell therapies to solid tumours at a global scale**

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# Zelluna: the right moment

| Game<br>changing<br>platform                         | World leading cell therapy platform, de-risked concept and path, that<br>may provide transformative treatments to<br>solid cancer patients<br>on a global scale                                                |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|                                                      |                                                                                                                                                                                                                |
| Land grab<br>therapeutic<br>field                    | Strong IP position provides an unprecedented opportunity to land grab an entire therapeutic field                                                                                                              |
|                                                      |                                                                                                                                                                                                                |
| Near term<br>clinical<br>inflection<br>point         | Lead program on the verge of the clinic, pathway validated through pre-IND with FDA, providing a near term value<br>inflection point<br>and catalyzation of significant value creation from the novel platform |
|                                                      |                                                                                                                                                                                                                |
| Small clinical<br>data sets<br>driving high<br>value | Approval path can be fast and with data from only <100 patients; high value deals on the bases of relatively few<br>patients                                                                                   |

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### Zelluna's novel cell therapy platform "TCR-NK" based on validated clinical components TCR + NK

#### **Nature's "guidance system": the T Cell Receptor (TCR) TCR-NK**

- The TCR is a clinically proven guidance system shown to enable cells to find and target solid cancers in patients
- There are two TCR based therapies approved for solid cancers
- Zelluna inserts a TCR into NK cells to guide them to solid cancers **+**

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#### **Nature's most efficient killers: Natural Killer (NK) cells**

- NKs are the most efficient cell killers in the body
- NKs can detect cancers in many ways, though do not have a TCR guidance system to target them to solid cancers

▪ NKs are clinically safe and can be produced at scale, upfront, frozen and stored for later use

i.e. "off the shelf"

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- ✓ Combines a proven targeting molecule, the TCR, with the most potent killer cells, NKs to form TCR-NK
- ✓ TCR-NK cells can detect and eliminate cancers in multiple ways – broad cancer detection capability
- ✓ TCR-NK cells can be produced at scale, upfront, frozen, stored and be used safely across patients i.e. "off the shelf".

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# Platform protection opens potential for huge value creation (comparison to owning the CAR-T IP space, only bigger)

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## TCR-NK platform proven to kill diverse tumours where clinical T cell benchmark falls short (video)

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#### **T cell clinical benchmark TCR-NK (Zelluna lead asset)**

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**TCR-NKs kills diverse cancers where clinical T cell benchmark falls short** 

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| PLATFORM | PROGRAM  | TARGET  | INDICATIONS                                     | DISCOVERY | PRECLINICAL | CLINICAL |
|----------|----------|---------|-------------------------------------------------|-----------|-------------|----------|
| TCR-NK   | ZI-MA4-1 | MAGE-A4 | NSCLC, Ovarian,<br>H&N Syn. Sarcoma             |           |             |          |
|          | ZI-KL1-1 | KK-LC-1 | Breast, Gastric,<br>Lung, Pancreatic,<br>Cervix |           |             |          |
|          | ZI-PR-1  | PRAME   | Solid Tumours                                   |           |             |          |

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#### **MultiClick Technology**

- The MultiClick platform consists of a flexible core molecule that can be selectively coupled to several modules
- Zelluna is currently exploring the merits of MultiClick and its potential value

#### **UV1 Program**

- The therapeutic cancer vaccine UV1 has been evaluated in five Phase II randomized controlled trials in various cancer types in combination with different checkpoint inhibitors
- Three of the Phase II trials, in malignant melanoma, mesothelioma and head and neck cancer, are completed with disappointing results and therefore the program will be wrapped up
- The remaining two trials, LUNGVAC and DOVACC, have completed enrolment and topline results are expected during 2025

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# **3 – Financial update**

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#### **Accounting acquirer**

• Legally, Zelluna ASA (former Ultimovacs ASA) has acquired Zelluna Immunotherapy ('ZI'). However, due to the valuation of ZI being significantly higher than Zelluna ASA, and that ZI's shareholders received a majority of the shares in Zelluna ASA in the business combination, ZI is regarded as the acquirer for accounting purposes.

#### **Accounting and presentation implications**

- The financial information presented for periods prior to the transaction reflects the operations, financial position, and cash flows of Zelluna Immunotherapy AS only (FY24 and Q1-2024).
- The financial information presented for Q1-2025 reflects Zelluna Immunotherapy AS (Jan March) + the rest of the Zelluna group (March) after the business combination.
- Zelluna ASA and Ultimovacs AB are consolidated into the accounting parent, Zelluna Immunotherapy AS in accordance with a reverse acquisition under IFRS 3 Business Combinations. This primarily effects how equity is consolidated, as all items in all balance sheets are consolidated at book value.
- No goodwill or bargain purchase has been booked in the PPA due to the insignificant amount, and the share price volatility.

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# Q1 2025 Key Financials

#### **Cash and liquidity**

- MNOK 135/MUSD 13 in cash by end of Q1 2025
- With the fully committed private placement of MNOK 51.7 at closing of the business combination, the financial runway is expected to last through Q2 2026 capturing the key IND catalyst for the TCR-NK technology

#### **EBIT and PBT**

- EBIT: Q1 2025 MNOK -29
- Profit before tax: Q1 2025 MNOK -28

#### **Other**

• Reverse share split effective 1 April 2025: 10 old shares converted into 1 new share

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# P&L and Cash

### **Key financials per Q1-2025 - Zelluna Group**

| NOK<br>(000)                                                            | Q1-24           | Q1-25           | FY24             |
|-------------------------------------------------------------------------|-----------------|-----------------|------------------|
| Total<br>revenues                                                       | -               | -               | 53               |
| Payroll<br>and<br>payroll<br>related<br>expenses                        | 10<br>513<br>,  | 6<br>425<br>,   | 38<br>131<br>,   |
| - Payroll<br>incl<br>. option<br>and<br>expenses not<br>costs<br>grants | 9<br>243<br>,   | 10<br>199<br>,  | 33<br>069<br>,   |
| - Share<br>and<br>public<br>option<br>costs<br>grants                   | 1<br>270<br>,   | -3<br>,774      | 5,062            |
| External<br>R&D<br>and<br>IPR<br>(incl<br>. grants)<br>expenses         | 18<br>832<br>,  | 13<br>011<br>,  | 52<br>902<br>,   |
| Other<br>operating<br>(incl<br>. depreciation)<br>expenses              | 6<br>485<br>,   | 9<br>891<br>,   | 18<br>591<br>,   |
| Total<br>operating<br>expenses                                          | 35<br>830<br>,  | 29<br>327<br>,  | 109<br>625<br>,  |
| (loss)<br>Operating<br>profit                                           | -35<br>830<br>, | -29<br>327<br>, | -109<br>572<br>, |
| financial<br>Net<br>items                                               | 3<br>052<br>,   | 978             | 4<br>409<br>,    |
| (loss)<br>Profit<br>before<br>tax                                       | -32<br>779<br>, | -28<br>349<br>, | -105<br>162<br>, |
|                                                                         |                 |                 |                  |
| increase/(decrease)<br>cash<br>and<br>cash<br>in<br>Net<br>eq.          | -29<br>036<br>, | 108<br>032<br>, | -99<br>525<br>,  |
| Cash<br>and<br>cash<br>equivalents<br>end<br>of<br>period<br>at         | 98<br>651<br>,  | 135<br>314<br>, | 27<br>690<br>,   |
| Number<br>of<br>end<br>of<br>period<br>FTEs<br>at                       | 2<br>1          | 2<br>7          | 2<br>2           |

•

#### **Comments**

#### **Payroll and payroll related expenses**

- 'Regular' payroll expenses were higher in Q1 2025 due to an increase in the number of employees in the Group compared to the same period in 2024. Personnel expenses for all employees in the new Zelluna group were included for one month (March).
- In Q1 2025, share option costs were reversed due to the termination of options for former employees.

#### **External R&D and IPR expenses**

• Lower R&D costs in Q1 2025 compared to the same period previous year, primarily a result of lower costs related to purchase of materials for CMC purposes in Q1 2025.

#### **Other operating expenses**

• 'Other operating expenses' were higher in Q1 2025 than in Q1 2024 due to the inclusion of Zelluna Group figures as of March 2025, including significant transaction costs related to the business combination.

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# Quarterly operating cash flow

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#### **Cash and liquidity**

- The operating cash-flow in Q1 2025 was approximately MNOK -36, differing from EBIT of MNOK -28 primarily due to share option expenses with no cash effect, as well as changes in working capital.
- The cash flow in Q1-Q4 2024 reflects Zelluna Immunotherapy AS's cash flow only, while Q1 2025 includes one month (March) of the rest of the of the Zelluna Group.

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# **4 - Summary**

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# Key milestones / value inflections

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# **Q&A**

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