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RNS - Lytix Biopharma Q1 2025: Strong clinical momentum supports a clear path to Phase III and broader pipeline progress

Company: Lytix Biopharma AS Date: 2025-05-15 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

### **Q1 2025 results presentation** 15.05.2025

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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.

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 May 15, 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

# **Q1 Highlights**

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

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

#### **Verrica to report on FDA meeting and additional data from Phase II study in the coming period**

- Verrica remains on track and expects to report genomic and immune response data from the Phase 2 trial in mid-2025
- Verrica is encouraged by their recent end of Phase II meeting with FDA
- Impressive 97% calculated objective response rate in BCC with overall reduction in tumor size of 86%
- Verrica plans to provide a global development program update, including the design of the phase 3 clinical program in mid-2025

#### **NeoLIPA – Expanding the Potential of LTX-315 into Early-Stage Resectable Melanoma**

- Patient recruitment ongoing and progressing as planned 8 patients treated to date
- Interim readout expected Q3 2025

#### **ATLAS-IT-05 – Encouraging data from 20 anti-PD-1 refractory melanoma patients**

- All patients have completed study treatment, the last patient visit is projected in July 2025
- Positive interim data; 40% disease control for up to **two years** in patients with progressive disease and who previously failed to respond to several lines of treatment

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

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

#### **LTX-401 – Advancing towards the clinic with strengthened commercial and regulatory momentum**

- Clinical trial preparations underway, targeting start of Ph. I study in 2026
- Positive regulatory feedback supports Lytix clinical development plan
- Partly validated by LTX-315's clinical results due to same mode-of-action

#### **Business and financial**

- To reinforce Lytix's focus on international business development and value-driving transactions for LTX-315, the company strengthened its leadership team with the appointments of Dr. Ahmed Bouzidi and Brent Meadows
- A new Board of Directors has been elected, further strengthening the company's strategic capabilities and industry expertise. The updated board brings together seasoned leaders with in-depth experience from biotechnology, oncology drug development, business development, and international commercialization
- Operating expenses declined as ATLAS-IT-05 nears completion, all patients treated and study close-out activities underway.

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## **Ramping up organization for commercialization**

| Eric Falcand<br>(Chair)   | 37+ years of intl. leadership and management experience in the<br>•<br>pharmaceutical industry<br>Has led over 50 licensing and partnership agreements globally<br>•                              | •<br>New board of directors elected at<br>the General Meeting in April to<br>further strengthen the Lytix                              |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Julie Dehaene<br>Puype    | Pharmaceutical executive with 25 years of intl. experience<br>•<br>•<br>Specialized in general management, commercial ops., sales &<br>marketing, new products development and regulatory affairs | organization for increased<br>commercial and partnership<br>activities                                                                 |
| Claus<br>Andersson        | •<br>More than 25+ years of venture experience<br>Experience from more than 20 international boards<br>•<br>General Partner at Sunstone Life Science Ventures<br>•                                | •<br>Additionally, Lytix<br>has<br>strengthened the team with the<br>appointments of Dr. Ahmed<br>Bouzidi as SVP and Brent             |
| Marie-Louise<br>Fjällskog | More than 25 years of experience in clinical oncology,<br>•<br>translational research, and drug development                                                                                       | Meadows as Chief Business<br>Officer.                                                                                                  |
| Brynjar<br>Forbergskog    | •<br>CEO of Saturn Invest AS and responsible for evolving Torghatten<br>ASA into one of the largest transportation groups in the Nordic<br>region                                                 | Brent Meadows (US based)<br>Strong track record in biotech deal<br>making and commercial strategy                                      |
| Kjetil<br>Hestdal         | Senior Life Science Executive and previously the Chief Executive<br>•<br>Officer of Photocure<br>ASA -<br>a commercial-stage company focused<br>on bladder cancer                                 | Dr. Ahmed Bouzidi (Switzerland<br>based)<br>Experienced immuno-oncology leader<br>with strong European and Chinese<br>market expertise |

**RE-ELECTED BOARD MEMBERS**

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## **Eric Falcand**

Words from the Chair

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## **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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### **LTX-315: A potential paradigm shift in treatment of BCC**

BCCs typically found in skin exposed to sun ~80% located on the face and head

Surgery can cause pain or discomfort, bleeding, infection and scars

*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*

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

**Study:**

Verrica Ph. II Completed

# **Clinical and Operational update**

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

1

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### **ATLAS-IT-05 (ongoing): Promising effects of LTX-315 in heavily pre-treated patients with late-stage 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

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

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

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**Complete regression in non-injected tumors**

**Study:** ATLAS-IT-05 Ongoing

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*"Stabilization of disease for over a year in this population gives more patients longer runway and options — something we rarely see in this setting" – Robert Andtbacka, Clinical Oncologist*

# **Clinical and Operational update**

New phase II study: Earlier stage melanoma (NeoLIPA)

1

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

#### **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

#### **Commercial Rationale**

- Early-stage melanoma patients have less advanced disease and a more robust immune system, increasing the likelihood of response to Lytix's immunotherapy
- This patient population is larger, translating into significant commercial potential

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**Study:** NeoLIPA Started

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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**

- Partly validated by LTX-315's clinical results due to same mode-of-action
- Positive regulatory feedback supports clinical path forward
- Clinical trial preparations progressing well, targeting initiation of Ph. I in 2026

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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      | Q1 2025  | Q1 2024  | FY 2024   |
|--------------------------|----------|----------|-----------|
| Total operating income   | -        | 10,526   | 11,134    |
| Total operating expenses | (13,439) | (29,212) | (107,029) |
| Loss from operations     | (13,439) | (18,685) | (95,896)  |
| Loss for the period      | (12,923) | (18,183) | (94,265)  |

• As previously communicated, the decline in operating expenses reflects the near completion of the ATLAS-IT-05 study. All patients have received treatment, and we are now in the close-out phase—finalizing data collection, cleaning the data room, and preparing both the clinical study report and the full dataset for reporting.

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## **Strengthened financial position going into 2025**

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**Total operating expenses**

**Cash and short-term financial investments**

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- Following the successful capital raise at the end of 2024, Lytix is in a strong liquidity position. This ensures sufficient runway and enhances our ability to act with strategic flexibility in a challenging macroeconomic environment.
- A focused pipeline and disciplined cost control supports continued progress toward development milestones, partnering activities, and ultimately the commercialization of LTX-315

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## **Key figures – balance sheet**

| Amounts in NOK '000                  | 31.03.2025 | 31.03.2024 | 31.12.2024 |
|--------------------------------------|------------|------------|------------|
| Assets                               |            |            |            |
| Property, plant and equipment        | 26         | 93         | 42         |
| Right-of-use assets                  | 2,807      | 213        | 2,589      |
| Trade and other receivables          | 9,355      | 18,840     | 13,113     |
| Short-term financial investments     | -          | 13,511     | -          |
| Cash and cash equivalents            | 117,903    | 12,661     | 130,791    |
| Total assets                         | 130,091    | 45,319     | 146,535    |
| Shareholder's equity and liabilities |            |            |            |
| Total equity                         | 95,172     | 33,771     | 107,894    |
| Total liabilities                    | 34,919     | 11,584     | 38,641     |
| Total equity and liabilities         | 130,091    | 45,319     | 146,535    |

- Total liabilities increased to NOK 35 million at the end of Q1 2025, up from NOK 12 million in Q1 2024, primarily due to accrued expenses associated with the ATLAS-IT-05 study.
- Our improved financial position provides a solid foundation to continue driving value through clinical development and future commercialization initiatives.

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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

### **Neoadjuvant melanoma Non and breast -metastatic skin cancer Deep seated cancer**

LTX-315: Phase II results in NeoLIPA Interim data Q3 2025 Final data H1 2026

LTX-401: Phase I study in deep seated tumors (2026) Technology partly validated by LTX-315

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

#### **Verrica - BCC**

- ‒ Report immune response data **(mid -2025)**
- ‒ Global development program update, including the design of the Ph. III clinical program (**mid -2025)**

#### **Lytix Clinical Development**

- ‒ Interim results from NeoLIPA **(Q3 2025)**
- ‒ Finalization of ATLAS-IT-05 study **(H2 2025)**
- ‒ LTX -401 Ph. I ready (**Q4 2026** )

### **Lytix Business Development**

‒ Continue to aim for late-stage development and 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               | Q1 2025   | Q1 2024   | FY 2024   |
| Revenue                                | -         | 10,526    | 11,134    |
| Other operating income                 | -         | -         | -         |
| Total operating income                 | -         | 10,526    | 11,134    |
|                                        |           |           |           |
| Payroll and related expenses           | (4,105)   | (5,663)   | (22,590)  |
| Depreciation and amortization expenses | (259)     | (242)     | (915)     |
| Direct R&D expenses                    | (6,266)   | (20,186)  | (72,565)  |
| Other expenses                         | (2,810)   | (3,121)   | (10,960)  |
| Total operating expenses               | (13,439)  | (29,212)  | (107,029) |
| Loss from operations                   | (13,439)  | (18,685)  | (95,896)  |
| Net financial items                    | 516       | 503       | 1,631     |
| Loss before tax                        | (12,923)  | (18,183)  | (94,265)  |
| Tax expense                            |           |           | -         |
| Loss for the period                    | (12,923)  | (18,183)  | (94,265)  |

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## Condensed interim statement of financial position

|                                      | Unaudited  | Unaudited  |            |
|--------------------------------------|------------|------------|------------|
| Amounts in NOK thousands             | 31.03.2025 | 31.03.2024 | 31.12.2024 |
| Assets                               |            |            |            |
| Non-current assets                   |            |            |            |
| Property, plant and equipment        | 26         | 93         | 42         |
| Right-of-use assets                  | 2,807      | 213        | 2,589      |
| Total non-current assets             | 2,832      | 307        | 2,631      |
|                                      |            |            |            |
| Current assets                       |            |            |            |
| Trade and other receivables          | 9,355      | 18,840     | 13,113     |
| Short-term financial investments     | -          | 13,511     | -          |
| Cash and cash equivalents            | 117,903    | 12,661     | 130,791    |
| Total current assets                 | 127,258    | 45,012     | 143,904    |
| Total assets                         | 130,091    | 45,319     | 146,535    |
| Shareholder's equity and liabilities |            |            |            |
| Issued capital and reserves          |            |            |            |
| Share capital                        | 6,826      | 4,007      | 6,816      |
| Share premium reserve                | 88,346     | 29,764     | 101,078    |
| Total equity                         | 95,172     | 33,771     | 107,894    |
|                                      |            |            |            |
| Liabilities                          |            |            |            |
| Non-current liabilities              |            |            |            |
| Lease liabilities                    | 1,962      | 41         | 1,878      |
| Total current liabilities            | 1,962      | 41         | 1,878      |
| Current liabilities                  |            |            |            |
| Trade payables                       | 5,830      | 4, 970     | 5, 015     |
| Other current liabilities            | 26,208     | 6,329      | 30,987     |
| Lease liabilities                    | 919        | 208        | 762        |
| Total current liabilities            | 32,957     | 11,508     | 36,764     |
|                                      |            |            |            |
| Total liabilities                    | 34,919     | 11,548     | 38,641     |
| Total equity and liabilities         | 130,091    | 45,319     | 146,535    |
|                                      |            |            |            |

![](_page_31_Picture_2.jpeg)

## Condensed interim statement of cash flows

|                                                          | Unaudited | Unaudited |          |
|----------------------------------------------------------|-----------|-----------|----------|
| Amounts in NOK thousands                                 | Q1 2025   | Q1 2024   | FY 2024  |
| Cash flows from operating activities                     |           |           |          |
| Loss for the period                                      | (12,923)  | (18,183)  | (94,265) |
| Adjustments for:                                         |           |           |          |
| Depreciation of property, plant and equipment            | 17        | 17        | 68       |
| Depreciation of right-of-use assets                      | 242       | 225       | 847      |
| Interest income/(expense), net                           | (199)     | (181)     | (1,503)  |
| Share-based payment expense                              | 201       | 634       | 878      |
| Increased/decreased in trade and other receivables       | 3,757     | (6,063)   | (336)    |
| Increased/decreased in trade and other payables          | (3,964)   | (764)     | 23,938   |
| Cash generated from operations                           | (12,869)  | (24,315)  | (70,372) |
| Income tax paid                                          | -         | -         | -        |
| Net cash flows from operations                           | (12,869)  | (24,315)  | (70,372) |
| Investing activities                                     |           |           |          |
| Investments in tangible assets                           | -         | -         | -        |
| Interest received                                        | 202       | 181       | 1,510    |
| Increase/decrease in other investments                   | -         | 9,673     | 23,183   |
| Net cash from/(used in) investing activities             | 202       | 9,854     | 24,693   |
|                                                          |           |           |          |
| Financing activities                                     |           |           |          |
| Interest paid                                            | (2)       | -         | (7)      |
| Proceeds from share issue                                | -         | -         | 161,295  |
| Transaction cost                                         | -         | -         | (11,333) |
| Payment of principal portion of lease liabilities        | (218)     | (242)     | (849)    |
| Net cash from/(used in) financing activities             | (221)     | (242)     | 149,105  |
| Net increase/(decrease) in cash and cash equivalents     | (12,888)  | (14,704)  | 103,426  |
| Cash and cash equivalents at the beginning of the period | 130,791   | 27,365    | 27,365   |
| Cash and cash equivalents at the end of the period       | 117,903   | (12,661)  | 130,791  |

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