AbilityPharma Announces € 7 Million Financing Round to Advance Development of its Clinical Phase 2b Autophagy Inducer ABTL0812 in Metastatic Pancreatic Cancer

The Catalan biopharmaceutical company Ability Pharmaceuticals, SA (AbilityPharma), focused on the development of innovative oral autophagy-inducing anticancer compounds, announces a €7M investment from a European-Canadian syndicate of life sciences investors, including CTI Life Sciences Fund, Inveready, the EIC Fund, Fitalent and CDTI Innvierte. The round was also supported by the company founders, the family offices IVAMOSA and GESAMO, and a collective investment campaign on the Capital Cell platform. The funding will allow the Company to fully finance its phase 2b clinical study of antitumor compound ABTL0812 in patients with pancreatic cancer.

These funds are added to the €2M of non-diluting funds granted to the company in 2023 by Spain’s Ministry of Science and Innovation through the Public-Private Collaborations and Strategic Lines programs with contributions from Next Generation funds from the European Union.

AbilityPharma is currently completing an international Phase 2b clinical trial with its product ABTL0812 in patients with metastatic pancreatic cancer, a disease with a very low survival rate, with the aim of demonstrating greater efficacy than the current standard treatment FOLFIRINOX. This is a double-blind, placebo-controlled, first-line study in combination with FOLFIRINOX chemotherapy, ongoing in 23 hospitals in Spain, the US, France, and Israel. All 140 patients included in the study have already been recruited. Efficacy results are expected by year-end.

Significant superior efficacy results in the clinical trial will allow AbilityPharma to obtain financing for final development of ABTL0812 and/or to license the molecule to a multinational pharmaceutical or biotechnology company that can complete its development, with the goal of making ABTL0812 available to pancreatic cancer patients in 2028.

“We are very pleased to complete this financing round and welcome CTI Life Sciences Fund’s Shermaine Tilley to our board of directors, which will enable us to accelerate the development of ABTL0812 in the short term”, stated Carles Domènech, PhD, Executive Chairman and CEO at AbilityPharma, and co-founder. “We are thankful to CTI Life Sciences, Inveready and the EIC Fund for completing this financing round, and to all our new and existing investors for their confidence in our team and for their support to our goals. This investment will allow us to continue working tirelessly on taking ABTL0812 to patients with pancreatic cancer”.

Shermaine Tilley, PhD, MBA, Managing Partner at CTI Life Sciences Fund, said “We are delighted to provide financing for late-stage development of Ability Pharma’s innovative and highly promising treatment for pancreatic cancer. I am pleased to assume a position on their board of directors and will work with management and the board to optimize the value of ABTL0812 for patients and for investors”.

Sara Secall, MSc, MBA, General Partner Inveready, said “We are excited to bring in savvy investors that can help move forward AbilityPharma’s treatment for cancer patients”.

Svetoslava Georgieva, Chair of the EIC Fund Board, said: “The EIC Fund has become a strong player in EU deep-tech investments. The unique financing approach through the EIC, combining grants and equity, is attracting significant interest from Europe's most promising start-ups and provides them with the means to develop and scale their businesses in Europe. Our investment will help Ability Pharma with the development of their product for patients with metastatic pancreatic cancer.”

An orphan disease:

Pancreatic cancer is considered an orphan disease with an urgent clinical need for new effective and safe therapies. Until now, chemotherapy has been the main treatment for all stages of pancreatic cancer. With ABTL0812, however, the effects of various types of chemotherapy are enhanced without increasing their toxicity.

Pancreatic cancer mostly affects people between 65 and 70 years old and is a tumor that is difficult to diagnose and has high mortality. In other words, pancreatic cancer is not the most frequent, but it is the one with the lowest survival rate among the main types of cancer: lung, colorectal, breast and prostate. It is currently the third leading cause of cancer death in Europe, where an annual mortality of 130,000 people is estimated for this type of cancer. Globally, pancreatic cancer is already the seventh leading cause of cancer-related death.

About ABTL0812:

ABTL0812 may transform the paradigm of first-line pancreatic cancer treatment. This new molecule for oral administration, with a completely innovative mechanism of action, causes the selective death of tumor cells through autophagy (self-digestion) without affecting healthy cells.

ABTL0812 has demonstrated clinical efficacy in an open-label Phase 2 clinical study in patients with endometrial cancer or squamous non-small cell lung cancer (sqNSCLC), as first-line treatment in combination with chemotherapy (CT) and as maintenance treatment after CT cycles. The trial included patients in Spain and France. In the case of lung cancer, patient survival doubled compared to historical controls. The results show a significant increase in efficacy over first-line standard of care (carboplatin + paclitaxel) in both overall response rate (ORR) and progression-free survival (PFS). Patients in the endometrial cancer group had an increase greater than 30% in ORR compared with standard of care treatment (66% ABTL0812 + chemotherapy vs. 51% chemotherapy alone) and a 38% increase in PFS (7.1 months vs. 9.8 months). In the sqNSCLC group, ORR increased by more than 40% compared to standard treatment (53% vs. 32%) and PFS increased by 44% (4.2 months vs. 6.2 months). Furthermore, overall survival (OS) analysis shows a 100% increase from 11.3 months in the best historical control to 22.5 months in patients with sqNSCLC treated with ABTL0812 + Chemotherapy.

ABTL0812 has also received Orphan Drug Designation (ODD) for pancreatic cancer, biliary cancer and pediatric neuroblastoma by the FDA in the US and the EMA in Europe.

The mechanism of action of ABTL0812 is unique and novel. ABTL0812 is a first-in-class, orally administered, molecule that binds to the nuclear receptors PPARα and PPARγ, inducing PPAR-dependent endoplasmic reticular stress (ER-stress) and blocking the activation of Akt, the central kinase of the PI3K/Akt/mTOR pathway. The combination of the inhibition of the PI3K/Akt/mTOR pathway and the induction of ER-Stress results in autophagy-mediated cancer cell death. The mechanism of action was published in Clinical Cancer Research in May 2016 and in Autophagy in May 2020. Additionally, ABTL0812 presents immunomodulatory antitumor effects by transforming "cold" tumors into immunogenic "hot" tumors. These effects were presented at the AACR meeting in April 2021. Final publication is ongoing.

In preclinical cancer models, ABTL0812 is effective as a single agent with an excellent safety profile in a broad spectrum of cancer types, including lung, endometrial and pancreatic cancer, neuroblastoma and glioblastoma. Likewise, ABTL0812 synergizes with chemotherapy and immunotherapies, while promoting a pro-inflammatory antitumor microenvironment. Translational results have been published in Gynecologic Oncology (2019), International Journal of Cancer and Cell Death and Disease (2020), Cancer Communications (2022), and Frontiers in Oncology (2022).

About Ability Pharmaceuticals:

AbilityPharma (www.abilitypharma.com) is a Catalan biopharmaceutical company with one product, ABTL0812, in Phase 2b clinical trials, focused on improving the future of oncology by developing innovative therapies that address unmet medical needs. In April 2016, AbilityPharma signed a territorial license agreement for ABTL0812 with SciClone Pharmaceuticals (Hong Kong) Development Co. Limited to develop and commercialize the product in China.

AbilityPharma is headquartered in the Parc Tecnològic del Vallès (Cerdanyola del Vallès, Barcelona, Catalonia, Spain). Among its current shareholders are its founders, private investors, Inveready, Fitalent, Innvierte (CDTI), SODENA, the EIC Fund and SciClone Pharmaceuticals, and it has the financial support of ACCIO (Government of Catalonia), CDTI, ICO, ENISA, the Ministry of Science and Innovation (Government of Spain) and the European Commission (H2020 program, European Innovation Council).

About CTI Life Sciences Fund:

CTI Life Sciences Fund (CTI LSF) is a lead Canadian biotech VC. Founded in 2006, CTI LSF has repeatedly demonstrated its ability to select world-class companies and generate industry-leading returns. In Canada, the United States, and Europe, CTI makes venture capital investments in innovative biotech companies with scientific and technological differentiation that can translate into novel therapies with blockbuster revenue potential. CTI Life Sciences Fund has $280M in assets under management. For more information, visit www.ctisciences.com.

About Inveready:

Inveready is a leading alternative asset manager in Spain - investing in early-stage VC, growth VC, venture debt, strategic equity in listed companies, infrastructure and private equity - providing financing solutions to companies throughout their life-cycle. Founded in 2008, Inveready counts on 203 active companies, 64 exits and more than €1bn of assets under management. Some of our biotechnology portfolio companies have established licensing agreements with multinationals such as Roche and Novartis or been acquired (AVX sold to Aerie, now Alcon). Other biotech companies are listed in public markets such as NASDAQ or the Spanish BME Growth. Visit www.inveready.com for more information.

About the EIC Fund:

The European Innovation Council Fund from the European Commission is an agnostic Fund: it invests across all technologies and verticals, and all EU countries and countries associated to Horizon Europe. It provides the investment component of the EIC Accelerator blended finance. The European Investment Bank acts as investment adviser to the EIC Fund. The EIC Fund aims to fill a critical financing gap and its main purpose is to support companies in the development and commercialization of disruptive technologies, bridging with and crowding in market players,and further sharing risk by building a large network of capital providers and strategic partners suitable for co-investments and follow-on funding.

The Fund pays particular attention to the empowerment and support of female founders as well as the ambition to reduce the innovation divide among EU countries. Visit eic.ec.europa.eu/eic-fund_en for more information.