PLUS THERAPEUTICS, INC. Corporate Presentation
March 2024
Forward Looking Statement
This presentation contains statements that may be deemed "forward-looking statements" within the meaning of U.S. securities laws, including statements regarding clinical trials, expected operations and upcoming developments. All statements in this presentation other than statements of historical fact are forward- looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as "potential," "anticipating," "planning" and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the potential promise of rhenium (186Re) obisbemeda including the ability of rhenium (186Re) obisbemeda to safely and effectively deliver radiation directly to the tumor at high doses; expectations as to the Company's future performance including the next steps in developing the Company's current assets; the Company's clinical trials including statements regarding the timing and characteristics of the ReSPECT-GBM,ReSPECT-LM and ReSPECT-PBC clinical trials; possible negative effects of rhenium (186Re) obisbemeda; the continued evaluation of rhenium (186Re) obisbemeda including through evaluations in additional patient cohorts; and the intended functions of the Company's platform and expected benefits from such functions.
The forward-looking statements included in this presentation could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: the early stage of the Company's product candidates and therapies, the results of the Company's research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company's liquidity and capital resources and its ability to raise additional cash, the outcome of the Company's partnering/licensing efforts, risks associated with laws or regulatory requirements applicable to it, market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field, ability to develop and protect proprietary intellectual property or obtain licenses to intellectual property developed by others on commercially reasonable and competitive terms, and material security breach or cybersecurity attack affecting the Company's operations or property. This list of risks, uncertainties, and other factors is not complete. Plus Therapeutics discusses some of these matters more fully, as well as certain risk factors that could affect Plus Therapeutics' business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including Plus Therapeutics' annual report on Form 10-K for the fiscal year ended December 31, 2023, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC's website at www.sec.gov. Any or all forward-looking statements Plus Therapeutics makes may turn out to be wrong and can be affected by inaccurate assumptions Plus Therapeutics might make or by known or unknown risks, uncertainties, and other factors, including those identified in this presentation. Accordingly, you should not place undue reliance on the forward-looking statements made in this presentation, which speak only as of its date. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.
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Targeted Radiotherapeutics for CNS Cancers
Corporate overview
Platform | CNS Cancer | ||
Technology | Focus | ||
+ | Nanoliposome and | + | Aggregate market |
Rhenium isotope- | opportunity of $10B for | ||
based theragnostic | current indications in | ||
pipeline | development | ||
+ | Novel, directly targeted | + | Leptomeningeal |
CNS radiotherapy | metastases (LM) has ~250k | ||
platform | patients per year with no | ||
+ | Highly scalable supply | approved treatments | |
chain | + | Recurrent glioblastoma | |
(rGBM) occurs in nearly all | |||
GBM patients with poor | |||
treatment options |
Compelling
Survival Data
- Interim rGBM Phase 2 data (n=15): 13 months median OS1 vs. SOC ~8 months2
- LM Phase 1 dose escalation (n=18): No DLTs and median OS of 10 months1 vs. expected SOC ~4 months3
Mid 2025
Cash Runway
- Sufficient cash runway to fund operations through mid-2025
- 2 active grants totaling $25M in support with many others pending
Significant
Milestones
- Completing rGBM Phase 2 in the next 12 months and interim data analysis at SNO 2024
- Completing LM single dose Phase 1 in 2024 and interim data analysis at SNO 2024
- Presenting FORESEE LM diagnostic trial data in mid 2024
1. | Data analyzed as of 01Oct23, presented at SNO 2023. | 3 |
2. | Wen et. al. Neuro Oncol. 2020 Aug 17;22(8):1073-1113.doi: 10.1093/neuonc/noaa106. | |
3. Nguyen et. al. Curr Oncol. 2023 Jun 19;30(6):5906-5931. doi: 10.3390/curroncol30060442.
Recent Press and Partnerships Highlight Accelerating Interest in Radiopharmaceuticals
Innovator | ||
Acquirer | ||
Date | 2/13/2023 | 4/24/2023 |
Deal Type | Asset Acquisition | License Deal |
Aggregate
$63M$425M
Value
• | $750K option fee | ||
• | $1.5M option | • | |
exercise | $40M upfront | ||
• | $10.5M | • | Development, |
Key Deal Terms | clinical/regulatory | regulatory, and | |
milestones | commercial-based | ||
• | |||
$50M sales | • | milestones ($425M) | |
milestones | Tiered royalties |
• Low-single digit royalties
5/10/2023 | 10/3/2023 | 12/26/2023 | 1/9/2024 | ||
Strategic | Company Acquisition | Company Acquisition | License Deal | ||
Collaboration | |||||
$1.7B | $1.4B | $4.1B | $61M | ||
• | $45M upfront | ||||
• | Development and | • | $28M upfront | ||
commercial-based | |||||
$12.50/share - 87% | $62.50/share - 104% | • | $33M equity | ||
milestones ($1.7B) | |||||
• | premium | premium | investment (19.9% of | ||
Mid-single | |||||
outstanding shares)
to double-digit tiered royalties
4
Unique Challenges with CNS Cancer Treatment
Plus' technology overcomes all key challenges
Blood Brain Barrier | Radiotherapy Limitations | Locally Invasive |
Only 2% of drugs cross | EBRT dose limited by off | 90% of GBM recurs 2 cm |
the BBB | target safety concerns | from primary tumor |
Chemoresistance | Surgical Therapy Inadequate | Complex Anatomy |
MGMT status and | Clean surgical margins | Getting 'drug on |
acquired resistance | unobtainable | tumor' more difficult |
Wen et. al. Neuro Oncol. 2020 Aug 17;22(8):1073-1113.doi: 10.1093/neuonc/noaa106.
Nguyen et. al. Curr Oncol. 2023 Jun 19;30(6):5906-5931. doi: 10.3390/curroncol30060442.5 Friedman, et al. Bevacizumab alone and in combination with irinotecan in recurrent glioblastoma. J Clin Oncol. 2009;27:4733-4740.
Rhenium (186Re) Obisbemeda is a 3-Part Formulation Radiotherapy
Improves CED and prolongs radiation exposure to tumor while sparing healthy tissue
Rhenium-186
(186Re)
BMEDA Small
Molecule
Chelates 186Re before
loading into the
nanoliposome where it is
irreversibly trapped
100 nm
Nanoliposome
Carries BMEDA-186Re to
target tumor and
improves retention
Tumor Retention
60% | 186Re-NanoLiposomes | |||
Activity | 50% | 186Re-BMEDA | ||
40% | 186Re-Perrenate | |||
% Injected | 30% | |||
20% | ||||
10% | ||||
0% | ||||
0 | 50 | 100 | 150 |
Time (hours)
Improved Drug Distribution
99mTc+NanoLiposome | 99mTc-BMEDA only |
Proprietary formulation promotes persistence in the tumor throughout the decay cycle of the isotope
Proprietary formulation improves convection and distribution throughout the brain
6
Direct Radiotherapeutic Delivery Strategies for CNS Cancers
Overcomes barriers to CNS drug delivery
Convection-Enhanced Delivery (CED)
- FDA-approvedand utilized for 20+ years
- Bypasses BBB
- 'Biological fracking': Controlled pressure and flow are optimal for drug delivery to region of interest
- Utilized for GBM and other brain tumors
Intraventricular Catheter (Ommaya reservoir)
- FDA-approvedand utilized for 60+ years
- Bypasses BBB
- Small subcutaneous reservoir with direct ventricle access
- Allows multidosing and CSF sampling
- Commonly placed in LM patients
Brain Parenchyma
Cerebrospinal Fluid
7
A New Paradigm for CNS Radiotherapy
A direct targeted approach is a step function improvement in CNS radiation delivery
Gold Standard
External Beam
Radiation Therapy
- Standard of care for decades
- Requires fractionation
- Limited absorbed dose due to off- target toxicity
- Mature technology
New Paradigm
Plus' Directly
Targeted RT Delivery
- Direct delivery to the tumor site
- Key challenges eliminated
+ Monitor drug location with real-time imaging
- Quantify absorbed doses
- Safe delivery of high activity
Imaging & Pre- | Biopsy & | Convection | Dosimetry & |
Treatment | Catheter | Enhanced | Imaging |
Planning | Placement | Delivery | 8 |
Seamless drug supply into patient workflow
Highly scalable workflow to meet commercial demand
Centralized GMP | Standard RAM Shipping |
Drug Order and Scheduling | Overnight Delivery |
Manufacturing | and Receiving |
Drug order scheduled and
timed to patient surgery date
The patient's dose is batch manufactured on demand prior to administration
Drug is delivered to hospital via standard overnight delivery
In-hospital transfer to nuclear
imaging for drug infusion
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Therapeutic Product Pipeline
Status and 2024 milestones
Preclinical | IND/ | Phase 1 | Phase 2 | Phase 3 | Anticipated Milestones 2024 |
IDE | |||||
Rhenium (186Re) Obisbemeda
• Data presentation at SNO Nov 2024
Single dose administration trial | ReSPECT-LM Single Dose Trial | • | Begin P2 in breast cancer | |||||
Leptomeningeal | ||||||||
Metastases | Multidose trial | ReSPECT-LM | Multidose | Trial | • | Initiate P1 basket trial | ||
Recurrent glioblastoma for small- | ReSPECT-GBM | • | Complete enrollment (n=34) | |||||
• | Interim data at SNO Nov 2024 | |||||||
Malignant | to-medium sized tumors | |||||||
• | Confirm pivotal trial design | |||||||
Gliomas | ||||||||
Pediatric high-grade glioma and | ReSPECT-PBC | • | IND approval & initiate enrollment | |||||
ependymoma | ||||||||
Rhenium NanoLiposome Biodegradable Alginate Microsphere (RNL-BAM) | ||||||||
Various Solid | Primary and Secondary Liver | • | Formulation optimization | |||||
Tumors | Cancer | |||||||
CNS tumors | Glioblastoma | • | Proof-of-concept studies | |||||
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Disclaimer
Plus Therapeutics Inc. published this content on 12 March 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 12 March 2024 23:05:02 UTC.
