ASX Release

Pipeline Collaboration for Next Generation Formulations

Melbourne, Australia (17 October 2018): Clinical-stage oncology company Prescient Therapeutics Ltd (ASX: PTX; Prescient) is pleased to announce that it has commenced a collaboration with a leading private US-based drug development company to develop new formulations of PH domain and Akt inhibitors, building on Prescient's knowledge gained during its development of PTX-200.

Prescient's internal pipeline development strategy seeks to maximize the value of the company's patents and know how, and includes the development of follow-on products behind PTX-200. The objective of this new collaboration is to develop novel proprietary formulations to expand the potential therapeutic applications of PTX-200 as a targeted cancer therapy. A core plank of this strategy is the generation of new intellectual property for Prescient.

Prescient CEO and Managing Director, Steven Yatomi-Clarke, said, "This pipeline collaboration is an important strategic initiative for Prescient. Not only does it complement our existing PTX-200 programs and leverage Prescient's experience with PTX-200, but it also presents new technologies and opens new opportunities for Prescient from a clinical perspective."

"Equally importantly, this collaboration is intended to generate new intellectual property for Prescient, as the Company aims to build on its deep understanding of the compound. Now that PTX-200 has demonstrated encouraging proof of concept in the clinic, it is timely to build beyond our experience with PTX-200 and to generate next-generation formulations for the Company."

"We look forward to sharing details with the market as this project develops and the patenting strategy permits."

PTX-200 is a targeted therapy that inactivates Akt, which plays a role in the development of many cancers, and contributes to treatment resistance. The compound is in a Phase 2 trial in women with HER2-negative locally advanced breast cancer where it has demonstrated encouraging efficacy signals. PTX-200 is also in a Phase 1b/2 trial in relapsed and refractory acute myeloid leukemia and in a Phase 1b/2 trial in platinum-resistant ovarian cancer.

The US Food & Drug Administration granted orphan drug designation for PTX-200 for the treatment of acute myeloid leukemia in 2017.

ENDS

About Prescient Therapeutics Limited (Prescient)

Prescient Therapeutics is a clinical stage oncology company developing targeted therapies that address specific mutations that drive cancer and contribute to resistance.

Prescient's lead drug candidate PTX-200 is a novel PH domain inhibitor that inhibits an important tumor survival pathway known as Akt, which plays a key role in the development of many cancers, including breast and ovarian cancer, as well as leukemia. Unlike other drug candidates that target Akt inhibition which are non-specific kinase inhibitors that have toxicity problems, PTX-200 has a novel mechanism of action that specifically inhibits Akt whilst being comparatively safer. This highly promising compound is now the focus of three current clinical trials:

  • Phase 2 study examining PTX-200 in breast cancer patients at the prestigious Montefiore Cancer Center in New York and Florida's H. Lee Moffitt Cancer Center (Moffitt). PTX-200 showed encouraging efficacy signals in the Phase 1b study, with twice the expected response rate.

  • Phase 1b/2 trial evaluating PTX-200 as a new therapy for relapsed and refractory Acute Myeloid Leukemia, being conducted the Moffitt; Yale Cancer Center in New Haven, Connecticut (Yale) and Kansas University Medical Center (KUMC) under the leadership of Professor Jeffrey Lancet, MD.

  • Phase 1b/2 trial of PTX-200 in combination with current standard of care is also underway in patients with recurrent or persistent platinum resistant ovarian cancer at the Moffitt.

Prescient's second novel drug candidate, PTX-100, is a first in class compound with the ability to block an important cancer growth enzyme known as geranylgeranyl transferase-1 (GGT-1). It inhibits the activation of Rho, Rac and Ral circuits in cancer cells, which act as key oncogenic pathways, leading to apoptosis (death) of cancer cells. PTX-100 was well tolerated and achieved stable disease in a Phase 1 trial in advanced solid tumors and will be the focus of studies in Ras and RhoA mutant malignancies.

Further enquiries:

Steven Yatomi-Clarke

Andrew Geddes

CEO & Managing Director

CityPR

Prescient Therapeutics Limited

+61 2 9267 4511

+61 417 601 440

Disclaimer and Safe Harbor Statement

Certain statements made in this document are forward-looking statements within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. These forward-looking statements are not historical facts but rather are based on the current expectations of Prescient Therapeutics Limited ("Prescient" or the "Company"), their estimates, assumptions, and projections about the industry in which Prescient operates. Material referred to in this document that use the words 'estimate', 'project', 'intend', 'expect', 'plan', 'believe', 'guidance', and similar expressions are intended to identify forward-looking statements and should be considered an at-risk statement. These forward-looking statements are not a guarantee of future performance and involve known and unknown risks and uncertainties, some of which are beyond the control of Prescient or which are difficult to predict, which could cause the actual results, performance, or achievements of Prescient to be materially different from those which may be expressed or implied by these statements. These statements are based on our management's current expectations and are subject to a number of uncertainties and risks that could change the results described in the forward-looking statements. Risks and uncertainties include, but are not limited to, general industry conditions and competition, general economic factors, the impact of pharmaceutical industry development and health care legislation in the United States and internationally, and challenges inherent in new product development. Investors should be aware that there are no assurances that results will not differ from those projected and Prescient cautions shareholders and prospective shareholders not to place undue reliance on these forward-looking statements, which reflect the view of Prescient only as of the date of this announcement. Prescient is not under a duty to update any forward-looking statement as a result of new information, future events or otherwise, except as required by law or by any appropriate regulatory authority.

Certain statements contained in this document, including, without limitation, statements containing the words "believes," "plans," "expects," "anticipates," and words of similar import, constitute "forward-looking statements." Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of Prescient to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Such factors include, among others, the following: the risk that our clinical trials will be delayed and not completed on a timely basis; the risk that the results from the clinical trials are not as favorable as we anticipate; the risk that our clinical trials will be more costly than anticipated; and the risk that applicable regulatory authorities may ask for additional data, information or studies to be completed or provided prior to their approval of our products. Given these uncertainties, undue reliance should not be placed on such forward-looking statements. The Company disclaims any obligation to update any such factors or to publicly announce the results of any revisions to any of the forward-looking statements contained herein to reflect future events or developments except as required by law.

This document may not contain all the details and information necessary for you to make a decision or evaluation. Neither this document nor any of its contents may be used for any other purpose without the prior written consent of the Company.

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Prescient Therapeutics Ltd. published this content on 17 October 2018 and is solely responsible for the information contained herein. Distributed by Public, unedited and unaltered, on 17 October 2018 01:07:03 UTC