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bottom line is that a highly speculative microcap in the oncology research basket. Better capital managers than others and right now you can take a share of a business with some near term possibilities of commercialisation and a market cap of 39 mil with 21 mil in cash on the balance sheet. Hold IRL and buyer at 4.5 cents
nice little nod to the possibility of commercialisation in the next 2 - 3 years for PTX. They’ve been pretty gentle in capital but I suppose it will cost a bit to run the phase 2 trial of PTX-100 in T cell lymphoma… but probably a lot less than a phase 3 trial
https://smallcaps.com.au/prescient-therapeutics-pivotal-year-ptx-100-development-treat-t-cell-lymphomas/
encouraging results… the glamour has been all about prescient’s CAR-T platform but PTX-100 is looking like it might be in patients in the shorter term…
Continued promising results in PTX-100 T Cell Lymphoma Phase 1b Cohort
Key Points:
Positive response rates, with two new complete responses in patients with relapsed and refractory PTCL since last update
7 of 10 evaluable patients had durations of response exceeding standard of care
Excellent safety profile maintained
Will modestly increase number of patients to create robust regulatory package
for FDA meeting, following recent Orphan Drug Designation from FDA
MELBOURNE Australia, 16 March 2023: Prescient Therapeutics Limited (ASX: PTX), a clinical stage oncology company developing personalised therapies to treat cancer, is pleased to provide an update on the PTX-100 Phase 1b expansion cohort in relapsed and refractory T cell lymphomas (TCL). PTX-100 continues to show encouraging clinical activity in this difficult-to-treat patient population, with several clinical responses that include two patients with relapsed and refractory peripheral TCL (PTCL) that have had complete responses (complete eradication of cancer) since the prior update in November 2022, which is not generally expected in this disease. PTX-100 also continues to exhibit an excellent safety profile at the highest dose of 2000 mg/m2. The study is being led by globally renowned haematologist, Professor H. Miles Prince at Epworth Hospital in Melbourne, Australia.
Phase 1b Enrolment
A total of 13 TCL patients have been dosed with PTX-100: 8 patients with PTCL and 5 patients with cutaneous TCL (CTCL). Patients had received a median of 3 prior lines of therapy and up to 5 systemic prior lines of therapy. PTX-100 was administered at doses up to 2,000 mg/m2. The expansion cohort has met its minimum enrolment schedule, and the study is ongoing as patients are responding for longer than expected (see Clinical Activity, below).
Four patients currently remain on therapy and additional patients are being recruited.
Safety
PTX-100 continues to exhibit an excellent safety profile on the study, with very few serious adverse events. Grade 3 (severe) adverse events observed as being possibly related to PTX-100 include cases of neutropenia, thrombocytopenia and anaemia. Several of these cases were observed in the same patient and the patients recovered/resolved these events. Prescient believes that such side effects are not uncommon in treating this patient population and are likely manageable.
Clinical activity
Although the primary goal of the study is to evaluate safety, PTX-100 continues to exhibit encouraging clinical activity in the difficult-to-treat patient population, especially when considered against responses expected from current standards of care. This is summarised in Table 1.
Table 1: Summary of TCL patients’ responses so far in PTX-100 Phase 1b study
Target1 Actual2 Target1 Actual2
1. Considered a target benchmark for a Phase 2 or registration study. S.M. Horowitz et al; Blood Dec 2021 2. Study ongoing; based on evaluable patients. Results as at 6 March 2023
Comments of note for this update:
All 13 TCL patients were assessable for safety; 10 patients were assessable for
efficacy. 5 patients had r/r PTCL and 5 patients had r/r CTCL.
Targeted progression free survival (PFS) is median, however with small patient
numbers in this study PTX is reporting mean PFS. In this update, PFS is impacted by newer patients on the study, whose treatments are in the earlier stages but remain ongoing. This results in a lowering of the overall PFS figures. PFS for r/r PTCL was 9.2 months and for r/r CTCL was 8.2 months.
In CTCL, an additional measure of clinical utility is Clinical Benefit Rate (CBR), which includes those patients with complete and partial responses and those with durable
Overall Response Rate
Progression Free Survival (months)
r/r TCL
(n=10)
>30%
40%
5-6
8.7
stable disease. Typically, CTCL therapies have a CBR of 50%1, so far on this study the observed CBR is 60%.
Individual patient responses are summarised in the swimmer plot in Figure1.
Figure 1: Swimmer plot of individual TCL patient responses and duration
Results as at 6 March 2023
SoC: duration of response (months) from current Standard of Care treatments
Target: Duration of response (months) that is considered a target benchmark for a Phase 2 or registration study (S.M. Horowitz et al; Blood; Dec 2021)
Next steps
Based on encouraging data so far, regulatory advisors have recommended enrolling seven additional patients in order to support a more robust data package for a meeting with the US FDA.
Prescient is planning a subsequent Phase 2 trial in TCL, which will be conducted subject to satisfactory Phase 1b outcomes. Prescient will seek to apply for this Phase 2 trial to be an Accelerated Approval trial with the FDA in an Orphan Indication. If this is granted, Accelerated Approval could pave the way for the Phase 2 trial to be the study enabling
1 H.M. Prince; et al; J Clin Oncol; 2010
expedited regulatory approval of PTX-100. If Accelerated Approval is not granted, the Phase 2 trial will proceed as per conventional drug development pathways, with a subsequent study likely required for approval.
Prescient will also be seeking clarification on the dose optimisation and dose schedule considerations for the Phase 2 study pursuant to the FDA’s Project Optimus, which seeks to maximizes not only the efficacy of a drug but also its the safety and tolerability.
Prescient will be applying for a meeting the FDA later this year. A favourable outcome would see the registrational Phase 2 study open within 12 months, subject to satisfactory results from the Phase 1b trial. A possible scenario may involve regulatory interactions taking place and/or a subsequent Phase 2 trial initiated before the current Phase 1b officially concludes, due to the long duration of responses being observed in this Phase 1b study.
To facilitate further studies, Prescient will conduct another manufacturing campaign of PTX- 100, planning for this has already commenced. Manufacturing will be conducted and documented at higher levels of rigour required to support later stage trials and regulatory submissions.
Prescient’s Chief Medical Officer, Dr Terrence Chew, said, “We are very pleased to see these promising efficacy and safety results in this difficult to treat patient population. With confirmation of these preliminary results, we expect to proceed expeditiously to a registration trial and to be able to provide PTX100 to these patients who desperately need more effective therapies.”
Prescient’s CEO and Managing Director, Steven Yatomi-Clarke, said, “It is very exciting to see this clinical data for PTX-100 continue to unfold so favourably, especially in these relapsed and refractory T cell lymphomas, which are particularly difficult to treat and where other therapies have failed. Unlike other TCL therapies, PTX-100 continues to exhibit an excellent safety profile, and the patient responses we are observing are very promising for a Phase 1b study.
Whilst Phase 1 trials necessarily focus on safety, we have a valuable opportunity to bolster our trial with a small number of additional patients to enable Prescient to have a more meaningful and productive dialogue with the FDA. This follows last week’s decision by the FDA to grant PTX-100 Orphan Drug Designation for all TCLs, and presents an exciting and unique opportunity for Prescient and for TCL patients awaiting more effective therapies.”
– Ends –
About Prescient Therapeutics Limited (Prescient)
Prescient Therapeutics is a clinical stage oncology company developing personalised medicine approaches to cancer, including targeted and cellular therapies.
Targeted Therapies
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 disrupts oncogenic Ras pathways by inhibiting the activation of Rho, Rac and Ral circuits in cancer cells, leading to apoptosis (death) of cancer cells. PTX- 100 is believed to be the only GGT-1 inhibitor in the world in clinical development. PTX-100 demonstrated safety and early clinical activity in a previous Phase 1 study and recent PK/PD basket study of hematological and solid malignancies. PTX-100 is now in a Phase 1b expansion cohort study in T cell lymphomas, where it is showing encouraging efficacy and safety. The US FDA has granted PTX-100 Orphan Drug Designation for all T cell lymphomas.
PTX-200 is a novel PH domain inhibitor that inhibits an important tumour 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, PTX-200 has a novel mechanism of action that specifically inhibits Akt without non-specific kinase inhibition effects. This highly promising compound is currently in a Phase 1b/2 trial in relapsed and refractory AML, where it has resulted in 4 complete remissions so far. PTX-200 previously generated encouraging Phase 2a data in HER2-negative breast cancer and Phase 1b in recurrent or persistent platinum resistant ovarian cancer.
Cell Therapies
OmniCAR: is a universal immune receptor platform enabling controllable T-cell activity and multi- antigen targeting with a single cell product. OmniCAR’s modular CAR system decouples antigen recognition from the T-cell signalling domain. It is the first universal immune receptor allowing post- translational covalent loading of binders to T-cells. OmniCAR is based on technology licensed from Penn; the SpyTag/SpyCatcher binding system licensed from Oxford University; and other assets.
The targeting ligand can be administered separately to CAR-T cells, creating on-demand T-cell activity post infusion and enables the CAR-T to be directed to an array of different tumour antigens. OmniCAR provides a method for single-vector, single cell product targeting of multiple antigens simultaneous or sequentially, whilst allowing continual re-arming to generate, regulate and diversify a sustained T-cell response over time.
Prescient is developing OmniCAR programs for next-generation CAR-T therapies for Acute Myeloid Leukemia (AML); Her2+ solid tumours, including breast, ovarian and gastric cancers; and glioblastoma multiforme (GBM).
CellPryme-M: Prescient's novel, ready-for-the-clinic, CellPryme-M technology enhances adoptive cell therapy performance by shifting T and NK cells towards a central memory phenotype, improving persistence, and increasing the ability to find and penetrate tumours. CellPryme-M is a 24-hour, non- disruptive process during cell manufacturing. Cell therapies that could benefit from additional
To stay updated with the latest company news and announcements, please update your details on our investor centre.
productivity in manufacturing or increased potency and durability in-vivo, would be good candidates for CellPryme-M.
CellPryme-A: CellPryme-A is an adjuvant therapy designed to be administered to patients alongside cellular immunotherapy to help them overcome a suppressive tumour microenvironment. CellPryme-A significantly decreases suppressive regulatory T cells; increases expansion of CAR-T cells in vivo; increases tumour penetration of CAR-T cells. CellPryme-A improves tumour killing and host survival of CAR-T cell therapies, and these benefits are even greater when used in conjunction with CellPryme-M pre-treated CAR-T cells.
The Board of Prescient Therapeutics Limited has approved the release of this announcement.
Find out more at www.ptxtherapeutics.com or connect with us via Twitter @PTX_AUS and LinkedIn.
Steven Yatomi-Clarke
CEO & Managing Director
Prescient Therapeutics
[email protected] [email protected]
Media enquiries:
Andrew Geddes – CityPR
+61 2 9267 4511 [email protected]
Investor enquiries:
Sophie Bradley – Reach Markets +61 450 423 331
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, global pandemics and related disruptions, the impact of pharmaceutical industry development and health care legislation in the United States and internationally, and challenges inherent in new product development. In particular, there are substantial risks in drug development including risks that studies fail to achieve an acceptable level of safety and/or efficacy. 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 favourable 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.
Supplemental COVID-19 Risk Factors
Please see our website : Supplemental COVID-19 Risk Factors
This straw is mostly to help me keep track of what's happening.
Today's announcement is a follow up to the one in July last year.
Essentially, the latest announcement is that the FDA has broadened the scope of Prescient's orphan drug designation for their drug PTX-100 from just peripheral T-cell lymphomas to all T-cell lymphomas.
The drug is not actually finished trials yet though. They say they expect to share updates on the trial shortly.
(Disc: held)
Nothing really new added in this 4C.
But the main thing I was looking for was anything about their CellPryme-M and CellPryme-A technologies. They've strongly hinted that they can licence this for money to other companies working on CAR-T therapies:
``Prescient believes the CellPryme platforms can open the door to potential licensing and commercial collaborations.''
But the current status is only:
``...management continues to raise awareness of these programs among the global medical community, the biotechnology industry and investors.''
Which sounds to me like any actual cash transactions for the technology will be at least a couple of years away. On the issue of timing they say:
``Such arrangements are always challenging to achieve and take time, but interactions so far have been encouraging.''
So I don't yet know what to think of how CellPryme should figure in the thesis, if at all. Thoughts welcome!
(Disc: held in RL and SM.)
easy to forget with the sexiness of OMNICAR and CAR-T that PTX has a couple of promising ‘targeted’ therapy drugs in trials.
bullish
PTX-100 Expansion Cohort Continues to Exhibit Safety & Encouraging Clinical Activity
Key Points:
Ongoing safety profile very favourable
PTX-100 continues to exhibit encouraging clinical activity
Additional CTCL patients to be added to trial
MELBOURNE Australia 25 October 2022: Prescient Therapeutics Limited (ASX: PTX), a clinical stage oncology company developing personalised therapies to treat cancer, is pleased to provide an update on the PTX-100 Phase 1b expansion cohort in relapsed and refractory T cell lymphomas (TCL). The study is being led by globally renowned haematologist, Professor H. Miles Prince at Epworth Hospital in Melbourne, Australia. PTX- 100 continues to exhibit an excellent safety profile at the highest dose of 2000 mg/m2. Moreover, PTX-100 continues to show encouraging clinical activity in a difficult to treat patient population, including a striking response in a patient with refractory cutaneous TCL (CTCL).
Phase 1b Enrolment
The expansion cohort has targeted 8-12 patients. A total of 8 patients have been screened and 7 patients have been dosed with PTX-100 in the expansion cohort so far: 4 with peripheral TCL (PTCL) and 3 with CTCL. Patients had received a median of 4 prior lines of therapy and up to 6 prior lines of therapy. PTX-100 was administered at 2,000 mg/m2. Four patients remain on therapy and additional patients are being recruited.
Safety
PTX-100 continues to exhibit an excellent safety profile on the study. There have been very few adverse events in the expansion cohort so far, and no serious adverse events related to PTX-100.
2 PTCL patients that had commenced therapy withdrew from the study for reasons unrelated to the trial. Another PTCL patient passed away due to reasons not associated with the study, as frequently occurs in studies of advanced malignancies. In each of these cases, subjects were not on the study long enough to observe responses, however, relevant pharmacokinetic and safety data were still collected, which are to the primary objectives of the study.
Clinical activity
Although the primary goal of the expansion cohort is to evaluate safety, PTX-100 continues to exhibit encouraging clinical activity in the difficult-to-treat patient population. An update of observed responses is summarised below:
Patient 121-003 (previously reported in dose escalation component of the study) with aggressive PTCL that had failed five prior treatments, had a partial response that endured for over 32 months before the disease progressed.
Patient 121-010 with CTCL that had failed 4 prior lines of therapy experienced a very good partial response (VGPR), which is almost a complete response, that has endured for 6 months so far. This patient remains on therapy. Please refer to the case study photos below.
Another 2 patients with CTCL that failed three prior therapies have experienced stable disease that have endured for 3-4 months so far and remain on therapy.
Case study: Patient 121-010
CTCL patient that had failed 4 prior therapies. Patient had VGPR on PTX-100 and is still on treatment.
Next steps
In light of these encouraging responses in CTCL in particular, Prescient has amended the study protocol to accommodate the recruitment of additional CTCL patients. Recruitment remains on schedule, notwithstanding the new objective of recruiting additional CTCL patients, which may commensurately extend the study period. The study will remain open while patients continue to derive clinical benefit from PTX-100. Prescient looks forward to providing further details on the expansion cohort study in the coming quarter.
Principle Investigator of the study, Professor H. Miles Prince, said, “We continue to see impressive responses in both systemic and cutaneous T cell lymphomas on this study. Furthermore, PTX-100 continues to be extremely well tolerated by patients. We look forward to continue accruing patients to the trial who otherwise have limited treatment options.”
Prescient’s CEO and Managing Director, Steven Yatomi-Clarke said, “It is very exciting to see PTX-100 show clinical activity in a patient population that is notoriously difficult to treat, and where these patients have failed several lines of prior therapies. Furthermore, PTX-100 continues to exhibit an excellent safety profile, which is uncharacteristic of available TCL therapies. It is exciting to see encouraging responses in CTCL patients, alongside PTCL patients, and we will aim to recruit more CTCL patients to the study. We look forward to sharing these updates with the market.”
– Ends –
About Prescient Therapeutics Limited (Prescient)
Prescient Therapeutics is a clinical stage oncology company developing personalised medicine approaches to cancer, including targeted and cellular therapies.
Cell Therapies
OmniCAR: is a universal immune receptor platform enabling controllable T-cell activity and multi- antigen targeting with a single cell product. OmniCAR’s modular CAR system decouples antigen recognition from the T-cell signalling domain. It is the first universal immune receptor allowing post- translational covalent loading of binders to T-cells. OmniCAR is based on technology licensed from Penn; the SpyTag/SpyCatcher binding system licensed from Oxford University; and other assets.
The targeting ligand can be administered separately to CAR-T cells, creating on-demand T-cell activity post infusion and enables the CAR-T to be directed to an array of different tumour antigens. OmniCAR provides a method for single-vector, single cell product targeting of multiple antigens simultaneous or
To stay updated with the latest company news and announcements, please update your details on
our investor centre.
sequentially, whilst allowing continual re-arming to generate, regulate and diversify a sustained T-cell response over time.
Prescient is developing OmniCAR programs for next-generation CAR-T therapies for Acute Myeloid Leukemia (AML); Her2+ solid tumours, including breast, ovarian and gastric cancers; and glioblastoma multiforme (GBM).
CellPryme-M: Prescient's novel, ready-for-the-clinic, CellPryme-M technology enhances adoptive cell therapy performance by shifting T and NK cells towards a central memory phenotype, improving persistence, and increasing the ability to find and penetrate tumours. CellPryme-M is a 24-hour, non- disruptive process during cell manufacturing. Cell therapies that could benefit from additional productivity in manufacturing or increased potency and durability in-vivo, would be good candidates for CellPryme-M.
CellPryme-A: CellPryme-A is an adjuvant therapy designed to be administered to patients alongside cellular immunotherapy to help them overcome a suppressive tumour microenvironment. CellPryme-A significantly decreases suppressive regulatory T cells; increases expansion of CAR-T cells in vivo; increases tumour penetration of CAR-T cells. CellPryme-A improves tumour killing and host survival of CAR-T cell therapies, and these benefits are even greater when used in conjunction with CellPryme-M pre-treated CAR-T cells.
Targeted Therapies
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 disrupts oncogenic Ras pathways by inhibiting the activation of Rho, Rac and Ral circuits in cancer cells, leading to apoptosis (death) of cancer cells. PTX- 100 is believed to be the only GGT-1 inhibitor in the world in clinical development. PTX-100 demonstrated safety and early clinical activity in a previous Phase 1 study and recent PK/PD basket study of hematological and solid malignancies. PTX-100 is now in a Phase 1b expansion cohort study in T cell lymphomas, where it has shown encouraging efficacy signals and safety.
PTX-200 is a novel PH domain inhibitor that inhibits an important tumour 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, PTX-200 has a novel mechanism of action that specifically inhibits Akt without non-specific kinase inhibition effects. This highly promising compound is currently in a Phase 1b/2 trial in relapsed and refractory AML, where it has resulted in 4 complete remissions so far. PTX-200 previously generated encouraging Phase 2a data in HER2-negative breast cancer and Phase 1b in recurrent or persistent platinum resistant ovarian cancer.
The Board of Prescient Therapeutics Limited has approved the release of this announcement.
Find out more at www.ptxtherapeutics.com or connect with us via Twitter @PTX_AUS and LinkedIn
Steven Yatomi-Clarke
CEO & Managing Director
Prescient Therapeutics
[email protected] [email protected]
Media enquiries:
Andrew Geddes – CityPR
+61 2 9267 4511 [email protected]
Investor enquiries:
Sophie Bradley – Reach Markets +61 450 423 331
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, global pandemics and related disruptions, the impact of pharmaceutical industry development and health care legislation in the United States and internationally, and challenges inherent in new product development. In particular, there are substantial risks in drug development including risks that studies fail to achieve an acceptable level of safety and/or efficacy. 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 favourable 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.
Supplemental COVID-19 Risk Factors
Please see our website : Supplemental COVID-19 Risk Factors
I always enjoy listening to Steve Yatomi-Clarke discuss PTX's progress and plans when I tune in. However, as a long term shareholder (IRL) I'm developing a touch of scepticism based on the regularity of presentations and IR exercises...
Steve presents weekly sometimes more than once in a week and whilst I understand they're a pre-revenue biotech and therefore communication and IR relations are pretty important. BUT... Does anyone worry that this is just a way to string the market along and continue to milk the market for cap raises? I don't feel this way with PTX, I feel they've been decent stewards of shareholder capital but I have some doubts just based on the extreme number of presentations...
Does anyone else have a view on this for PTX or more generally?
As I mentioned in the straw about the CellPryme-M platform, I'm looking to see if this new program is causing an increase in costs like @GazD suggested.
Their most recent 4C actually had a pretty big decrease in operating cash flow: -$1,167,000 (June) vs -$1,633,000 (March), which is largely driven by a reduction in R&D costs: $493,000 (June) vs $1,072,000 (March). Their prior 4C (December 2021) had R&D in the middle $827,000, and September 2021 was roughly the same.
In the most recent 4C, on the topic of CellPryme-M they say that ``This program has been in development for some time in stealth mode whilst data was generated and patents filed.'' and so maybe the higher R&D spends in the previous quarters accounted for that.
The takeaway: so far it looks like the CellPryme-M platform isn't leading to increased costs. Of course, a significant reduction in R&D spending by a biotech is an interesting fact by itself, since that's basically their entire business. So I'll be watching to see what happens there.
(Disc: held)
[Edited to add disclaimer]
I dug into some of the details of the announcement in @GazD's straw. So the company is saying that one of the main problems with Car-T therapies is that the production process produces too many of the wrong kind of T-cell. But they've developed a pre-treating process that takes only 24 hours, after which you then take the cells and stick them into your standard production process for whatever treatment you're producing. This then results in more of the right kinds of cell after the full production is completed. In particular, the cells will last longer and be better able to locate the tumors that they're trying to attack.
They're saying that they can use these to improve their own products, but I suspect that probably the most important thing about the announcement is that they're aiming to make this available to other companies to licence for their own drug development. They claim it's ready now, so if this turns out to be true, and they can get other companies interested, then I think the company could really be in good shape, and importantly, can start getting earning some cash before they run out --- their March 4C estimated 2 years of remaining cash. The other important implication of the announcement, as @GazD suggests, is this new program might increase expenses and force them to pass the hat around much sooner.
So, what I'm watching: can they get any traction on this CellPryme-M platform by the end of CY2022? How much are expenses increasing in their next 2 quarterly updates?
(Disc: held)
Not much to report, but I finally got around to following up wtih Rebecca Lim (Prescient's Director of Scientific Affairs) about their IP and the announcement about the expansion of their PTX-100 trial. In retrospect, I should have been more specific with my questions, so I didn't get a particularly informative response. At any rate, here's the questions that I asked:
Here's Rebecca's response:
"To answer your questions: we’ve licensed the IP for the OmniCAR system which comprises of the SC/ST system from Oxford University and the SC/ST application for cell therapies which is from U Penn. OmniCAR is unique amongst universal immune receptor systems due to its covalent binding system and rapid binding. This addresses challenges in the field as unbound binders can negatively impact targeting of the tumour cells and/or safety concerns associated with unbound binders in circulation.
The PTX-100 trial outcomes are yet unpublished as we are moving onto an expansion trial now. You might have seen on the same ASX announcement, we have seen some encouraging results with relapsed/refractory PTCL patients and will be expanding into a cohort focusing on this patient group."
So it's still not clear to me exactly what differentiates the Omnicar system from other Spytag/Spycatcher systems, but her brief mention about covalent binding matches what is described in this paper [Minutolo et al. (2020), J.Am.Chem.Soc. 142], so I'm assuming that this is the same thing. None of the authors on that paper are listed on Prescient's website, although in their latest investor presentation (ASX announcement 4/8/21) the two authors who declared patents in the paper are both mentioned, so presumably they have some relationship with the company.
(Disc: held)