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IP - Lytix Biopharma Q2/H1 2025: Preparing for a milestone-rich second half with advancing clinical programs and strengthened organization - Attachment: 2025-Q2 - Lytix Biopharma - Quarterly Presentation -

Company: Lytix Biopharma AS Date: 2025-08-28 Language: English Register to download
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# **Developing the future of cancer treatment**

Fighting cancer by local killing of tumor cells and systemic activation of the immune system

### **Q2 2025 results presentation** 28.08.2025

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# **Disclaimer**

This presentation (the "Presentation") has been prepared by Lytix Biopharma AS ("Company") exclusively for information purposes.

The Presentation is being made only to, and is only directed at, persons to whom such presentation may lawfully be communicated ('relevant persons'). Any person who is not a relevant person should not act or rely on the Presentation or any of its contents.

The Presentation does not constitute an offering of securities or otherwise constitute an invitation or inducement to any person to underwrite, subscribe for or otherwise acquire securities in the Company. The release, publication or distribution of the Presentation in certain jurisdictions may be restricted by law, and therefore persons in such jurisdictions into which this Presentation is released, published or distributed should inform themselves about, and observe, such restrictions.

The Presentation contains certain forward-looking statements relating to the business, products, financial performance and results of the Company and/or the industry in which it operates. Forward-looking statements concern future circumstances and results and other statements that are not historical facts, sometimes identified by the words "believes", expects", "predicts", "intends", "projects", "plans", "estimates", "aims", "foresees", "anticipates", "targets", and similar expressions. The forward-looking statements contained in the Presentation, including assumptions, opinions and views of the Company or cited from third party sources are solely opinions and forecasts which are subject to risks, uncertainties and other factors that may cause actual events to differ materially from any anticipated development. Neither the Company nor its employees provides any assurance that the assumptions underlying such forward-looking statements are free from errors nor does any of them accept any responsibility for the future accuracy of the opinions expressed in the Presentation or the actual occurrence of the forecasted developments. The Company assumes no obligation, except as required by law, to update any forward-looking statements or to conform these forward-looking statements to its actual results.

The Presentation contains information obtained from third parties. You are advised that such third-party information has not been prepared specifically for inclusion in the Presentation and the Company has not undertaken any independent investigation to confirm the accuracy or completeness of such information. Lytix Biopharma relies on publicly available information from Verrica Pharmaceuticals for some of the information shared in this material.

An investment in the Company involves risk, and several factors could cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements that may be expressed or implied by statements and information in the Presentation, including, among others, the risk factors described in the Company's information document dated 14 June 2021. Should any risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in the Presentation.

No representation or warranty (express or implied) is made as to, and no reliance should be placed on, any information, including projections, estimates, targets and opinions, contained herein, and no liability whatsoever is accepted as to any errors, omissions or misstatements contained herein, and, accordingly, neither the Company nor its directors or employees accepts any liability whatsoever arising directly or indirectly from the use of the Presentation.

By attending or receiving the Presentation you acknowledge that you will be 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.

The Presentation speaks as of August 28, 2025. Neither the delivery of this Presentation nor any further discussions of the Company with any of the recipients shall, under any circumstances, create any implication that there has been no change in the affairs of the Company since such date.

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# **Presenting team**

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### **Øystein Rekdal, CEO**

Co-founder of Lytix Biopharma, Dr. Rekdal has served as CEO twice in Lytix, most recently since 2019. With a PhD in tumor immunology, his expertise in anticancer molecules from host defense peptides underpins Lytix's technology. He is a regular speaker at international oncology conferences and was instrumental for the licensing deal with Verrica Pharmaceuticals.

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#### **Gjest Breistein, CFO**

Mr. Breistein, a state-authorized public accountant, joined Lytix in 2017 after advising companies at PwC on capital market transactions. He holds a Master's degrees in Applied Economics and Finance (Copenhagen Business School) and Professional Accountancy (BI Norwegian School of Management).

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# **Company introduction**

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# **Lytix Biopharma approaching commercialization**

### **Novel, unique and innovative technology**

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Lytix technology **already clinically proven** 

Dual mode of action: **targeted killing** and **systemic immunotherapy**

Based on world leading research on molecules derived from natures defense system

### **Robust portfolio of clinical studies**

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Targeting different types of **solid cancers**

Three **phase II studies completed or ongoing**

Expanding into deep seated tumors

### **Strong phase II results in basal cell carcinoma**

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Led by licensing partner Verrica Pharmaceuticals **Most common cancer type** worldwide

Overall reduction in tumor size of **86%** 

**Phase III** study next step

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# **Lytix addresses major shortcomings in current cancer immunotherapy**

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# **Lytix's solution works through two phases; killing tumors locally and activating a systemic broad immune response**

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7

# **Q2 Highlights**

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# **Highlights for the second quarter (I/II)**

### **- And post quarter end**

### **Verrica partnership – advancing LTX-315 toward Phase III in BCC**

- Successful FDA End-of-Phase II meeting confirmed alignment on a pivotal Phase III program.
- Preparations for Phase III are ongoing, including exploration of strategic, non-dilutive financing options.
- A comprehensive overview of the BCC program and additional genomic and immune response data from the Phase II trial will be presented at a scientific conference later in 2025.
- Lytix remains in ongoing dialogue with Verrica, driven by a commitment to making the treatment available to patients and healthcare professionals as swiftly and responsibly as possible.

### **NeoLIPA – neoadjuvant melanoma study gaining momentum**

- One-third of patients enrolled and treated to date.
- Interim data will be presented at the Nordic Melanoma Meeting, Tromsø, November 10-12th, 2025.

### **ATLAS-IT-05 – late-stage melanoma trial completed**

- All patient treatments finalized in Q2.
- Data confirm disease control in ~40% of patients who had failed prior therapies, with responses observed both locally and in distant metastases.
- Results underscore rationale for shifting focus to earlier-stage, neoadjuvant treatment.

# **Highlights for the second quarter (II/II)**

### **- And post quarter end**

### **LTX-401 – pipeline progress**

- Strong preclinical results and further optimization is ongoing to ensure that the best formulation is selected for clinical development
- Future development strategy under review to determine optimal timing and pathway for advancement.
- Lytix' proprietary drugs are progressing as planned with consistently positive results

### **Business and financial**

- Net loss for Q2 2025 substantially reduced compared to previous quarters and is mainly due to the NOK 10.2 million reversal of prior accruals for ATLAS-IT-05 following correction of Keytruda pricing assumption.
- NOK 100 million in cash and short-term financial investments as of June 30, 2025.
- Strengthened board and management with extensive biotech commercialization expertise.

# **Clinical and Operational update**

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# **Clinical progress**

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# **Clinical and Operational update**

1 Phase II study: Basal cell carcinoma (Verrica Pharmaceuticals)

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**Study:** Verrica Ph. II Completed

## **LTX-315 in BCC: Phase III study the next step**

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Productive End-of-Phase II meeting with FDA, alignment with on advancement into a pivotal Phase III trial

Verrica will present a comprehensive update on the BCC program at a scientific conference later this year *Based on primary market research, surveyed physicians believe LTX-315 has the potential to be utilized as a first line therapy, alternative to or complimentary to less invasive surgery*

Source: https://www.tv2.no/nyheter/viral/kenneth-40-trodde-han-hadde-kvise-pa-nesen-fikk-alvorligbeskjed-hos-legen/14511455

## **LTX-315 in BCC: A major commercial opportunity for both Lytix and Verrica Pharmaceuticals**

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### **REGULATORY PATH AND NEXT STEPS**

- Verrica held a constructive end of Phase II-meeting with the FDA
- Phase III study design and funding under discussion
- Genomic and immune response data expected in coming months

*Following our End-of-Phase 2 meeting with the FDA, we now have additional clarity and broad agreement on advancing this unique and promising therapy into a pivotal Phase III program and preparation activities are underway. We plan to explore opportunities to fund the basal cell program, which may include strategic, non-dilutive partnerships for financing both the development of this program as well as post-approval commercialization for this potential multiple billion-dollar opportunity in the most common form of skin cancer.*

**- Verrica Pharmaceuticals** In their Q2 statements, August 2025

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# **Clinical and Operational update**

Phase II study: Late stage melanoma (ATLAS-IT-05)

1

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## **ATLAS-IT-05: Promising effects of LTX-315 in heavily pre-treated patients with latestage melanoma**

!

**Complete regression in injected tumors**

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- Disease control in 40% of the patients up to **24 months**
- Two patients achieving a durable partial response
- Impressive effects in both injected and non-injected lesions
- Strong rationale for moving into earlier-stage melanoma patients with a more robust immune system

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**Complete regression in non-injected tumors**

**Baseline scan 28 mm** lesion in left gluteus muscle

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**Day 547 scan No** lesion in left gluteus muscle

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## **ATLAS-IT-05: Path forward**

### **From Late-Stage Validation to Neoadjuvant Opportunity**

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Strong clinical responses in late-stage melanoma enabled us to move LTX-315 into earlier-stage patients

The neoadjuvant setting (treatment before surgery) offers a unique opportunity, where immune systems are more robust and potential for long-term remission is greater

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NeoLIPA is the first step toward Lytix's broader plan to advance and commercialize LTX-315 in the neoadjuvant setting.

*Stabilization of disease for over a year in this population gives more patients longer runway and options - something we rarely see in this setting.*

**Study:** ATLAS-IT-05 Completed

*– Robert Andtbacka, Clinical Oncologist*

18

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# **Clinical and Operational update**

New phase II study: Earlier stage melanoma (NeoLIPA)

1

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**Study:** NeoLIPA Ongoing

20

### **NeoLIPA – Expanding the potential of LTX-315 Investigator Initiated Trial**

#### **Rationale**

- Early-stage melanoma patients have less advanced disease and a more robust immune system, increasing the likelihood of response to Lytix's immunotherapy
- With positive NeoLIPA results, LTX-315 in neoadjuvant setting could potentially be used in several types of cancer, translating into significant commercial potential

#### **Study Overview**

- Evaluate LTX-315 in combination with pembrolizumab (PD-1 inhibitor), administered **prior to surgery**, in treatment naive patients with a robust immune system
- **Dual mode of action**, in which LTX-315 can shrink tumors pre-surgery while boosting tumor-specific immune cells, potentially lowering relapse risk after surgery
- Led by **Dr. Henrik Jespersen**, Head of Melanoma at Oslo University Hospital

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# **Clinical and Operational update**

### LTX-401

1

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# **LTX-401 – a small oncolytic molecule with a large commercial potential, including deep-seated cancer**

### **LTX-401 approaching clinical stage**

- Proprietary asset of Lytix
- Partly validated by LTX-315's clinical results due to same mode-of-action
- Positive regulatory feedback supports clinical path forward
- Future development strategy under review to determine optimal timing and pathway for advancement

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### **Small molecule** Similar mode-of-action as LTX-315

with superior effects in liver cancer models

### **Significant commercial potential**

Suited for treatment of various solid tumor types, including deep-seated lesions

### **New superior formulation**

Improved anti-cancer effects and potential to extend patent life for LTX-401

# **Synergy effects**

Demonstrates strong synergy with checkpoint inhibitors

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# **Financials and outlook**

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# **Key figures – profit and loss**

| Amounts in NOK '000      | Q2 2025 | Q2 2024  | FY 2024   |
|--------------------------|---------|----------|-----------|
| Total operating income   | -       | -        | 11,134    |
| Total operating expenses | (5,157) | (21,540) | (107,029) |
| Loss from operations     | (5,157) | (21,540) | (95,896)  |
| Loss for the period      | (5,051) | (21,435) | (94,265)  |

- Net loss for Q2 2025 significantly reduced compared to previous quarters, reflecting a one-off accrual adjustment and lower R&D activity.
- Reversal of NOK 10.2 million related to ATLAS-IT-05 (Keytruda pricing adjustment from U.S. to European levels) was the main driver behind the improved result.
- Excluding this accounting effect, the trend is consistent with expectations: reduced R&D costs as ATLAS-IT-05 moves into its closure phase, partially offset by continued investments in development

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# **Lean Cost Base and Solid Runway into 2026**

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**Cash and short-term financial investments**

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*\*) NOK 9.2 million in cost for production of LTX-315 sold to Verrica in Q1 2024 has been excluded*

- Overall, operating expenses reflect tight cost control and focus on LTX-315 development, with no parallel late-stage trial running at this point.
- Cash position remains solid and supports operations into 2026, providing flexibility ahead of key catalysts in H2 2025.

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# **Key figures – balance sheet**

| Amounts in NOK '000                  | 30.06.2025 | 30.06.2024 | 31.12.2024 |
|--------------------------------------|------------|------------|------------|
| Assets                               |            |            |            |
| Property, plant and equipment        | 18         | 76         | 42         |
| Right-of-use assets                  | 2,565      | 2,998      | 2,589      |
| Trade and other receivables          | 7,281      | 14,410     | 13,113     |
| Short-term financial investments     | 60,072     | -          | -          |
| Cash and cash equivalents            | 40,191     | 60,181     | 130,791    |
| Total assets                         | 110,127    | 77,665     | 146,535    |
| Shareholder's equity and liabilities |            |            |            |
| Total equity                         | 90,024     | 59,221     | 107,894    |
| Total liabilities                    | 20,103     | 18,444     | 38,641     |
| Total equity and liabilities         | 110,127    | 77,665     | 146,353    |

- Cash and short-term financial investments totaled NOK 100.3 million at the end of the period.
- Total liabilities decreased significantly from NOK 38.6 million at year-end 2024 to NOK 20.1 million at the end of June 2025. The primary driver of this reduction was the reversal of previously recorded accruals related to the ATLAS-IT-05 study,

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# **Lytix Biopharma's roadmap to create shareholder value**

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LTX-315: Clear path towards commercialization, demonstrated through licensing with Verrica Pharmaceuticals

LTX-315: Phase II results in NeoLIPA Interim data Q4 2025 Last patient expected treated H1 2026 **Neoadjuvant melanoma Non and breast -metastatic skin cancer Deep seated cancer**

LTX-401: Strong preclinical results and novel formulation remain promising

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## **Executing on our strategy – upcoming events**

### **Lytix Clinical Development**

- ‒ NeoLIPA interim results (Nov 2025) – key inflection point
- ‒ Completion of ATLAS -IT -05 study (H2 2025)

#### **Verrica - BCC**

- ‒ Preparing for pivotal Phase III trial
- ‒ Exploring non-dilutive funding options
- ‒ Additional immune/genomic data + program update in H2 2025

### **Pipeline & Partnerships**

- ‒ Continued preparations for LTX -401
- ‒ Strategic focus on late -stage development & commercialization through partnerships

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# **Interim financial statements**

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# Condensed interim statement of profit and loss

|                                        | Unaudited | Unaudited |           |
|----------------------------------------|-----------|-----------|-----------|
| Amounts in NOK thousands               | Q2 2025   | Q2 2024   | FY 2024   |
| Revenue                                | -         | -         | 11,134    |
| Other operating income                 | -         | -         | -         |
| Total operating income                 | -         | -         | 11,134    |
| Payroll and related expenses           | (3,546)   | (4,715)   | (22,590)  |
| Depreciation and amortization expenses | (249)     | (230)     | (915)     |
| Direct R&D expenses                    | 3,209)    | (13,170)  | (72,565)  |
| Other expenses                         | (4,571)   | (3,424)   | (10,960)  |
| Total operating expenses               | (5,157)   | (21,540)  | (107,029) |
| Loss from operations                   | (5,157)   | (21,540)  | (95,896)  |
| Net financial items                    | 107       | 105       | 1,631     |
| Loss before tax                        | (5,051)   | (21,435)  | (94,265)  |
| Tax expense                            |           | -         | -         |
| Loss for the period                    | (5,051)   | (21,435)  | (94,265)  |

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# Condensed interim statement of financial position

|                                                               | Unaudited        | Unaudited   |              |
|---------------------------------------------------------------|------------------|-------------|--------------|
| Amounts in NOK thousands                                      | 30.06.2025       | 30.06.2024  | 31.12.2024   |
| Assets                                                        |                  |             |              |
| Non-current assets                                            |                  |             |              |
| Property, plant and equipment                                 | 18               | 76          | 42           |
| Right-of-use assets                                           | 2,565            | 2,998       | 2,589        |
| Total non-current assets                                      | 2,583            | 3,074       | 2,631        |
|                                                               |                  |             |              |
| Current assets                                                |                  |             |              |
| Trade and other receivables                                   | 7,281            | 14,410      | 13,113       |
| Short-term financial investments<br>Cash and cash equivalents | 60,072<br>40,191 | -<br>60,181 | -<br>130,791 |
| Total current assets                                          | 107,544          | 74,591      | 143,904      |
| Total assets                                                  | 110,127          | 77,665      | 146,535      |
|                                                               |                  |             |              |
| Shareholder's equity and liabilities                          |                  |             |              |
| Issued capital and reserves                                   |                  |             |              |
| Share capital                                                 | 6,826            | 4,961       | 6,816        |
| Share premium reserve                                         | 83,198           | 54,260      | 101,078      |
| Total equity                                                  | 90,024           | 59,221      | 107,894      |
| Liabilities                                                   |                  |             |              |
| Non-current liabilities                                       |                  |             |              |
| Lease liabilities                                             | 1,720            | 2,266       | 1,878        |
| Total current liabilities                                     | 1,720            | 2,266       | 1,878        |
| Current liabilities                                           |                  |             |              |
| Trade payables                                                | 2,715            | 4,196       | 5,015        |
| Other current liabilities                                     | 14,730           | 11,251      | 30,987       |
| Lease liabilities                                             | 938              | 731         | 762          |
| Total current liabilities                                     | 18,383           | 16,178      | 36,764       |
| Total liabilities                                             | 20,103           | 18,444      | 38,641       |
| Total equity and liabilities                                  | 110,127          | 77,665      | 146,535      |
|                                                               |                  |             |              |

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# Condensed interim statement of cash flows

|                                                          | Unaudited | Unaudited |          |
|----------------------------------------------------------|-----------|-----------|----------|
| Amounts in NOK thousands                                 | Q2 2025   | Q2 2024   | FY 2024  |
| Cash flows from operating activities                     |           |           |          |
| Loss for the period                                      | (5,051)   | (21,435)  | (94,265) |
| Adjustments for:                                         |           |           |          |
| Depreciation of property, plant and equipment            | 8         | 17        | 68       |
| Depreciation of right-of-use assets                      | 242       | 213       | 847      |
| Interest income/(expense), net                           | (108)     | (182)     | (1,503)  |
| Share-based payment expense                              | (86)      | (105)     | 878      |
| Increased/decreased in trade and other receivables       | 2,075     | 4,430     | (336)    |
| Increased/decreased in trade and other payables          | (14,604)  | 4,147     | 23,938   |
| Cash generated from operations                           | (17,526)  | (12,914)  | (70,372) |
|                                                          |           |           |          |
| Income tax paid                                          | -         | -         | -        |
| Net cash flows from operations                           | (17,526)  | (12,914)  | (70,372) |
| Investing activities                                     |           |           |          |
| Investments in tangible assets                           | -         | -         | -        |
| Interest received                                        | 112       | 182       | 1,510    |
| Increase/decrease in other investments                   | (60,072)  | 13,511    | 23,183   |
| Net cash from/(used in) investing activities             | (59,960)  | 13,693    | 24,693   |
|                                                          |           |           |          |
| Financing activities                                     |           |           |          |
| Interest paid                                            | (3)       | -         | (7)      |
| Proceeds from share issue                                | -         | 50,000    | 161,295  |
| Transaction cost                                         | -         | (3,011)   | (11,333) |
| Payment of principal portion of lease liabilities        | (223)     | (249)     | (849)    |
| Net cash from/(used in) financing activities             | (226)     | 46,740    | 149,105  |
|                                                          |           |           |          |
| Net increase/(decrease) in cash and cash equivalents     | (77,712)  | 47,519    | 103,426  |
| Cash and cash equivalents at the beginning of the period | 117,903   | 12,661    | 27,365   |
| Cash and cash equivalents at the end of the period       | 40,191    | 60,181    | 130,791  |

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