The Company’s main goal remains to accelerate the development of breakthrough biologic therapies for the treatment of oncological conditions. The Company’s Board of Directors has also decided to resume the service business in order to provide new sources of revenue and make optimal use of the Company’s resources.
The Company has identified as key development goals for the period 2023-2024:
To continue the intensive development of activities in the discovery of new therapies, with the leading projects PB004 and PB003G:
- Conducting clinical Phase 0 (first-in-human study) for projects PB004 and PB003G by the end of 1H 2024. Start of Phase 0 is planned in 2023, preliminary results are expected in 1Q 2024.
- Conduct at least one partnering transaction by the end of 1H 2024. Pure Biologics’ preferred partnering model will be one in which the Company takes an active role in the further development of the projects (intensification of discussions in connection with obtaining in vivo results).
- Expand the portfolio to a total of five drug projects at various stages of development by the end of 2024.
Further optimizing the disbursement of external capital, including by:
- Postponing, relative to the approved schedule, the commissioning of the full CMC package in the PB003G project until the results of Phase 0 are available.
- Expanding the portfolio of ongoing projects, which will help ensuring the repeatability of the business model in the medium and long term, based on expected grant funding, without requiring additional expenditures from the Company.
- Continuation of activities oriented toward the development of drug and aptamer projects also in the form of external special purpose vehicles.
- Restarting of service activities to ensure new sources of revenue and optimal use of the Company’s resources. By the end of 2025. Pure Biologics plans to generate more than PLN 10 million from its services business.
Dr. Filip Jeleń, co-founder, major shareholder and CEO of Pure Biologics said:
We are at an advanced stage of preparation for Phase 0 in projects PB004 and PB003G. The study is expected to start at the end of 2023, and we expect preliminary results in both projects in Q1 2024. This will be a key milestone that will result in the first results in humans. In parallel, we are starting the next phase of partnering discussions with potential partners. We invariably expect to conduct at least one transaction in the period 2023-1H2024. In parallel, we are pursuing activities oriented toward rebuilding our innovative portfolio. We have secured our own share, while the launch of new projects depends on access to grant funding. We hope to know the delayed results of grant competitions soon.
We have decided to resume service activities to provide the company with new sources of revenue and make optimal use of our resources. We are beginning to build the foundation of this branch of the business. As we have a lot of experience and relationships in this area, we are counting on the first revenues as early as 2024, and by the end of 2025 we plan to exceed PLN 10 million in service business revenues.
Romuald Harwas, Board Member and CFO of Pure Biologics said:
Since the beginning of the year, we have been working intensively to secure the financing necessary to implement our plans, and we have recorded several successes in this regard. At the same time, we have adjusted the Company’s resources to meet the needs of our planned activities. On the operational side, we are very well prepared to carry out the development plans presented.
The Company’s goal is to conduct partnering transactions for at least either PB004 or PB003G projects. Since 2022 Pure Biologics has been intensifying partnering talks and has identified several potential partners from the pharmaceutical industry. With the results of the animal studies, the Company has begun the next phase of discussions with potential partners.
Project PB004 is a potential biologic drug. The molecule is being developed for the treatment of selected hematological malignancies, including chronic lymphocytic leukemia, as well as for the treatment of solid tumors, including triple negative breast cancer.
In July 2023, in vivo studies demonstrated the ability of the developed antibody to inhibit tumor growth in a human tumor model. Based on the results of the animal studies, the project has been qualified to Phase 0.
The PB003G project is also a potential biologic drug. It is being developed for the treatment of solid tumors, including non-small cell lung cancer (NSCLC).
In September 2023, in vivo studies demonstrated the ability to activate the immune system in humanized mice and a favorable safety profile, but no significant effects on regulatory T (Treg) cell counts or tumor growth were observed. In the context of the observed high potential in human in vitro studies, the Company has decided, as a cost optimization measure, to halt further in vivo studies and CMC work and direct the project directly to Phase 0 clinical trials to explore the therapeutic potential in the human tumor microenvironment. This represents a reduction in capital needs in the run-up to 1H 2024 of about PLN 12 million relative to earlier plans.
Conducting a Phase 0 clinical trial is expected to yield the first information on the effectiveness of compounds in humans up to two years faster than the classic approach, based on Phase I and II clinical trials. At the same time, the data will be obtained at a significantly lower financial burden than that of the aforementioned classical approach.
Framework schedule for the development of projects PB003G and PB004:
- Q4 2023 – filing of an eIND (exploratory IND, application for permission to start a Phase 0 clinical trial) and start of a Phase 0 clinical trial (first studies in humans),
- Q2 2024 – final phase 0 results (expected partial results in Q1 2024).
The Company will take measures oriented toward minimizing the expenditures required for further development of the PB004 and PB003G projects once the results of the Phase 0 clinical trial are available.
By the end of 2024, the Company plans to have a total of five drug projects in its portfolio at various stages of development to ensure a repeatable business model. The development of further projects will depend on raising non-dilutive funding, including primarily in the form of grants. Pure Biologics assumes that it will be able to obtain new grant funds as early as 2023-1H2024. Due to the typical characteristics of scientific projects, in the first years of project development, expenditures related to R&D processes are limited, which will naturally determine a relatively low demand for equity capital.
The company has decided to reconstitute the company’s service business, with the aim of providing new sources of revenue and optimally utilizing the company’s resources. Pure Biologics plans, within the framework of the subsidiary company, to provide services to pharmaceutical and biotechnology companies primarily in the field of selection of active molecules (antibodies and aptamers) together with their biophysical and biological characterization for medical applications (drugs and therapeutic procedures, diagnostics), as well as production and analysis of recombinant proteins and development of measurement methods.
In this regard, Pure Biologics will initiate recruitment processes to build the foundation of a sales team tasked with creating an offer and starting sales. By the end of 2025. Pure Biologics plans to generate more than PLN 10 million from its services business.
The Company estimates the costs associated with the implementation of these Development Plans over the period until the end of 2024 at PLN 185 million, of which approximately PLN 68.6 million the Company has already secured as of the date of these Development Plans (cash in its possession and grants awarded), and an amount of PLN 50-55 million the Company plans to secure in the form of expected grants (implementation of new projects that do not require additional capital for own contribution) and revenues from commercial services. The remaining amount of PLN 62-67 million the Company plans to raise from external sources of financing, among which are: venture debt, the capital market, project commercialization, or infrastructure rental. If a partnership agreement is signed during the period of these Development Plans, it may secure a significant portion or all of the above capital needs.