Pure Biologics has completed the strategic options review process.
- The Company’s received a PLN 12 million loan (venture debt) from ACRX Investments Limited, after the Company fulfilled all conditions set forth in the agreement with the investor signed in April.
- We estimate the costs associated with the 2023-1H2024 Development Plans presented in May at about PLN 178 million. The company has already secured approx. PLN 107 million of this amount, and plans to secure another PLN 38-43 million from grants, which will not generate additional equity requirements. The remaining amount of PLN 28-33 million is expected to come from other potential sources of financing, among them: a partnering agreement, venture debt, the capital market, or infrastructure rental. If a partnering agreement is signed during the period of implementation of these Development Plans, it could secure a significant part or all of the above capital needs.
- On May 25, Pure Biologics’ General Meeting of Shareholders approved the adoption of authorized capital, which secures one of the potential sources of capital.
Dr. Filip Jeleń, co-founder, major shareholder and CEO of Pure Biologics, said:
We are working very hard to secure the company’s capital needs. At the moment, we have 107 million zlotys out of the 178 million zlotys necessary to implement our development plans for the period 2023-1H2024. We plan to raise the remaining amount from grants – relevant applications in competitions have already been submitted by us – and other sources. We are continuing discussions with potential partners. If the plan to sign at least one partnering agreement in the coming months is realized, we would succeed in meeting a significant part or all of the capital needs assumed by the end of 1H 2024. In parallel, we are securing other options.
Romuald Harwas, Board Member and CFO of Pure Biologics said:
Since the beginning of 2023, we have put a lot of commitment into aligning the Company’s resources with the needs of the activities planned until the middle of next year. We have strengthened our cash position, we are in discussions with potential partners for our flagship projects, and we have received approval from our shareholders for our target capital – our intention is to use it as economically as possible. We therefore have a wide range of tools at our disposal to finance the development plans recently presented to investors.
In the Development Plans presented in May, the Company identified key targets in the 2023-1H2024 period:
- Focus on intensive preclinical, clinical and business development of drug projects PB003G and PB004.
- Begin Phase 0 in both projects in 2023 and complete it by the end of H1 2024; achieve the ability to start Phase 1 clinical trials in H2 2024.
- Conduct at least one partnering transaction in the period 2023-1H2024.
- Optimize the business and financial model and portfolio for the possibility of developing drug and aptamer projects also in the form of external SPVs.
- To have a total of at least four drug projects at various stages of development in the portfolio by mid-2024.
The Company’s goal is to conduct partnering transactions against at least one of the PB003G and PB004 projects. Starting in 2022. Pure Biologics is stepping up partnership talks and has identified several potential pharmaceutical partners. According to the Company, the progress of the talks indicates that the first transaction could potentially be possible once the expected results of the animal studies are obtained, which according to the assumed schedule should take place in Q2 2023.
In April 2023 Pure Biologics announced the nomination of lead candidates for projects PB003G and PB004.
Project PB003G is developing a dual-action therapeutic antibody that simultaneously eliminates immunosuppressive regulatory T (Treg) cells in the tumor microenvironment and stimulates cytotoxic NK and T cells to directly target tumor cells. According to the Company, the results of the PB003G project show clear advantages over drug candidates with promising results in early clinical development. PB003G is an attractive drug concept with a very strong competitive advantage for commercialization in the cancer therapy market, with potential in the treatment of solid tumors.
The PB004 project is also a potential biologic drug, and involves the development of a new therapeutic molecule in the format of an afucosylated IgG1 class antibody to stimulate the immune response of NK cells against tumor cells bearing the tumor antigen ROR-1, leading to their direct killing by an ADCC (Antibody-dependent cellular cytotoxicity) mechanism. The PB004 molecule is being developed for the treatment of solid tumors, including triple-negative breast cancer, as well as for the treatment of selected hematological cancers, including chronic lymphocytic leukemia, among others.
Framework development schedule for PB003G and PB004 projects:
- Q2 2023 – Conduct preclinical study packages including the first studies in an animal model with the proprietary molecules – determining the pharmacodynamic (PD) properties required to obtain authorization to initiate a Phase 0 clinical trial
- Q3 2023 – Determination of pharmacokinetic (PK) properties and conduct of a preclinical safety study (toxicological study in an animal model) required to obtain authorization to initiate a phase 0 clinical trial
- Q4 2023 – filing of an eIND (exploratory IND, application for permission to initiate a phase 0 clinical trial) and initiation of a phase 0 clinical trial (first studies in humans)
- Q2 2024 – final phase 0 results (expected partial results in Q1 2024).
The execution of the Development Plans is expected to allow the completion of the full suite of preclinical studies for Phase 1 and IND filing, and to be ready to start clinical Phase 1 trials in patients with solid tumors (PB003G) and leukemia (PB004) in Q4 2024.
The company also plans to optimize its business and financial model and portfolio for the possibility of developing projects also in the form of external SPVs. Based on the experience of other entities in the biotech/medtech industry, Pure Biologics allows for the possibility of developing certain projects in the form of SPVs, which would be able to attract industry and/or financial partners with specialized know-how at an early stage, and develop certain innovations until the developed technologies can be transacted for sale to an external partner. The company plans to minimize any financial investment of its own in the development of SPVs.
The first such project is PB103, for which a special purpose vehicle (SPV), Doto Medical Sp. z o.o., has been established to develop an innovative medical device based on Pure Biologics’ PureApta technology for improving the effectiveness of hemodialysis in patients suffering from chronic kidney disease (CKD). PB103 is being developed by Pure Biologics and Relitech B.V. (Netherlands), an experienced entity that develops medical devices from concept to production stage under contract work.
By mid-2024, the Company plans to have a total of at least four 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. The company assumes that it will be able to obtain new grant funds as early as 2023-1H2024. Due to the typical characteristics of scientific projects, R&D spending is limited in the first years of project development, which will naturally determine the level of demand for equity capital.