BioinvestGPT_IntroDeck_Feb2025
BioinvestGPT_IntroDeck_Feb2025
(BioinvestGPT)
10x more correct GO/NO-GO Decision-Making for Biopharma Decision-makers
Disclaimer
This Presentation does not constitute, or form part of, nor is it intended to communicate, any offer, invitation, inducement or recommendation to sell or issue, or any solicitation of any offer to purchase or subscribe for, any shares in
any entity affiliated with BioinvestGPT (the “Company” hereafter) in any jurisdiction nor shall it, or any part of it, or the fact of its distribution, form the basis of, or be relied on in connection with or act as any inducement to enter into,
any contract therefor.
Use of Assumptions: Preparation of this Presentation requires the Company to make certain estimates and assumptions. While the Company has used reasonable endeavours to ensure the estimates and assumptions are based
on the best available information but actual results could be materially different. The Company shall not be liable for any errors, inaccuracies or delays in the information, nor for any actions taken in reliance thereon. The Company
disclaims all warranties, express or implied, as to the accuracy or completeness of any of the content provided, or as to the fitness of the content for any purpose to the extent permitted by law. This Presentation is intended for
information purposes only and is provided without any warranty of any kind, either expressed or implied. Due to various risks and uncertainties, actual events or results or actual performance of the Company may differ materially
from any opinions, forecasts or estimates reflected or contemplated in this Presentation. These statements are not guarantees of future performance, condition or results. There can be no assurance that future results or events will
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achievement or reasonableness of, and no reliance should be placed on, such forward looking statements. The Company undertakes no duty or obligation to publicly update or revise the forward‐looking statements or other
information contained in this material. While some information used in this material may have been obtained from various published and unpublished sources considered to be reliable, the Company neither guarantees its accuracy
or completeness nor accepts liability for any direct or consequential losses arising from its use. Amounts and percentages may reflect rounding adjustments and consequently totals may not appear to sum.
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estimates contained in this Presentation. No statement in the Presentation is intended to be, or intended to be construed as, a profit forecast or profit estimate or to be interpreted to mean that earnings per Company share for the
current or future financial years will necessarily match or exceed the historical earnings per Company share. Any investment in the Company is speculative, involves a high degree of risk, and could result in the loss of all or
substantially all of their investment. Results can be positively or negatively affected by market conditions beyond the control of the Company or any other person. As a result, no undue reliance should be placed on such
statements.
FDA 2025 Guidance of GO/NO-GO Decision-Making AI Performance Metrics
In 2024, Top 20 big pharma and major shareholders have trusted BioinvestGPT using those FDA-recommended
performance metrics in an ex-ante, real-world GO/NO-GO decision-making setting.
* Source: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-use-artificial-intelligence-support-regulatory-decision-making-drug-and-biological
Figures are AS IS subject to updates from time to time without warranty of any kind.
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Ex-ante Clinical Prediction Validation
* All confidence intervals (CIs) are Agresti-Coull. BioinvestGPT Performance Data: https://analysis.bioinvestgpt.com/
Figures are AS IS subject to updates from time to time without warranty of any kind.
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Ex-Ante GO/NO-GO Decision Correct Rate WY2024
BioinvestGPT’s ex-ante clinical benefit prediction performance has been proven to increase FIC/BIC GO/NO-GO decision-making accuracy to
96% across all four biopharma-prioritized therapeutic areas, with 92% GO decision accuracy (vs 5-10% industry standard) and 98% NO-
GO decision accuracy at scale for both the preclinical stage and clinical stages.
* As of January 2 2025, 368 clinical readouts have been announced to validate the corresponding BioinvestGPT prospective clinical benefit predictions for all therapeutic areas, resulting in 96%
overall accuracy (353/368 validated prospective predictions; 99% CI; P < 0.0001), an 12% improvement over the 84% overall accuracy (146/173 trials) achieved by BioinvestGPT for 2020-2022.
BioinvestGPT Performance Data: https://analysis.bioinvestgpt.com// in which Tab T0 is for all indications and Tabs T2-T6 are for biopharma-prioritized therapeutic areas.
** All confidence intervals (CIs) are Agresti-Coull.
Figures are AS IS subject to updates from time to time without warranty of any kind.
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Compelling evidence shows that BioinvestGPT-informed ex-ante GO/NO-GO decision-making
would be 663 times more likely to be correct than incorrect.
BioinvestGPT for universal clinical benefit prediction (DOR 663) even outperforms PCR Test for COVID-19 (DOR 316) in terms of
maximizing true predictions (correct GO/NO-GO decisions) and minimizing false predictions (incorrect GO/NO-GO decisions).
The confidence in Interpretation: BioinvestGPT-informed Interpretation: As the most reliable Interpretation: Conventional GO/NO-GO
BioinvestGPT for prospectively GO/NO-GO decision-making is 663 times and adopted test for diagnosing decision-making is 94% more likely to
correctly predicting both more likely to correctly identify COVID-19 worldwide, PCR test is 316 falsely initiate the clinical development
successes and failures blockbuster FIC/BIC assets (true times more likely to correctly identify of a commercially insufficient FIC/BIC
positives) and rule out commercially COVID-19 patients (true positives) and assets (false positives) and falsely
Positive Likelihood Ratio / insufficient FIC/BIC assets (true rule out healthy population (true discontinue the clinical development of
Negative Likelihood Ratio negatives), compared with the chance of negatives), compared with the chance of a blockbuster FIC/BIC asset (false
making an incorrect decision (false making an incorrect diagnosis (false negatives), compared with the chance of
positives and false negatives). positives and false negatives). making a correct decision (true positives
and true negatives).
* All confidence intervals (CIs) are Agresti-Coull. BioinvestGPT Performance Data: https://analysis.bioinvestgpt.com/
** Arshadi et al. (2022). Diagnostic Accuracy of Rapid Antigen Tests for COVID-19 Detection: A Systematic Review With Meta-analysis. Frontiers in Medicine, 9.
https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2022.870738
*** The DOR for current drug GO/NO-GO decision-making approach is estimated based on the more optimistic 10% nomination rate (https://www.boehringer-
ingelheim.com/science-innovation/human-health-innovation/drug-discovery-boehringer-ingelheim).
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Value For BigPharma: Bottomline-Maximizing Partnership (++Revenue & --Impairment)
Guaranteed blockbuster drug discovery and internal expertise enhancement with unlimited BioinvestGPT virtual trials.
GO --Impairment
Blockbuster
Internal Drug Candidate Discontinued
Knowledge Blockbuster Hypothesis Screening further development
Internal/Public
Experimental
Graphs Drug Candidate with BioinvestGPT’s NO- of NO-GO candidates
Continously Hypothesis almost all of which
Data
Enhanced with Generation
Unlimited SoC-controlled
Virtual Clinical Trials with
GO would indeed be
BioinvestGPT underperforming drugs
Actionable Rationale
++Expertise Enhancement
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Value For BigPharma: Use Cases
BioinvestGPT is helping pharma partners shift from a “fail often and fail late” old paradigm to a “succeed often and
succeed early” new reality now.
Discover Blockbuster Assets Acquire Blockbuster Drugs Expand Blockbuster Indications Prolong Blockbuster Sales
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Value for BigPharma: Blockbuster R&D Productivity
BigPharma could achieves 100x R&D productivity for blockbuster drugs compared with other big pharma
companies (10x faster blockbuster launches at 10% R&D cost)
Blockbuster BigPharma
Drugs /Year
10 BioinvestGPT-based blockbuster-discovering
BigPharma
virtual P3 head-to-head clinical trial cost
$ 1B/Blockbuster Drug
Partners
100% BioinvestGPT-based blockbuster-discovering
virtual P3 head-to-head clinical trials &
8 BioinvestGPT-derisked human clinical trials
Bi 10 10 Blockbuster Drugs / Year
6
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nv
0x
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4
Industry’s Average
$11B
1 Blockbuster Drug / Year
$1B $3B $5B $7B $9B
R&D Cost/
Blockbuster Drug
Sources: Mullard, A. How much do phase III trials cost?. Nat Rev Drug Discov 17, 777 (2018). https://doi.org/10.1038/nrd.2018.198
Figures are AS IS subject to updates from time to time without warranty of any kind.
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Problem
The biopharmaceutical industry’s benchmark of clinical success rate for new drugs remains at 5% - 10% from
1980 to present.
* Vas Narasimhan, et al. the Science and Business of Innovative Medicines, a16z Podcast, 2019 Figures are AS IS subject to updates from time to time without warranty of any kind.
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Cause
Ligand-protein interaction data cannot 70% biomedical experimental data Past clinical trial data cannot
generalize to new ligand-protein
are irreproducible. generalize across even the most
interactions (Mastropietro et al. 2023
similar trials, let alone new trials
Nature Machine Intelligence**). (Baker et al. 2016 Nature*). (Checkroud et al. 2024, Science***).
*Baker, M. 1,500 scientists lift the lid on reproducibility. Nature 533, 452–454 (2016). https://doi.org/10.1038/533452a
**Mastropietro, A., Pasculli, G., & Bajorath, J. (2023). Learning characteristics of graph neural networks predicting protein–ligand affinities. Nature Machine Intelligence, 5(12), 1427–1436.
https://doi.org/10.1038/s42256-023-00756-9
*** Chekroud, A. M., Hawrilenko, M., Loho, H., Bondar, J., Gueorguieva, R., Hasan, A., Kambeitz, J., Corlett, P. R., Koutsouleris, N., Krumholz, H. M., Krystal, J. H., & Paulus, M. (2024). Illusory generalizability of clinical
Figures are AS IS subject to updates from time to time without warranty of any kind.
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prediction models. Science, 383(6679), 164–167. https://doi.org/10.1126/science.adg8538
Solution
2% coding genome
98% noncoding genome
A/T/C/G is the unified programming A/T/C/G contains all the causal knowledge of how
language of life that generalizes to every human body works that have been constantly used to A/T/C/G constitutes both the 2% coding genome
living and extinct species over the past 3.7 execute life function every second of a human’s life. and the 98% non-coding genome that enables a
billions years on earth. structured understanding of multi-scale
mechanisms from genotype to phenotype.
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Feasibility
BioinvestGPT and embryogenesis use the data-free approach to building human bodies.
BioinvestGPT Embryogenesis
uses genome as the uses genome as the
reliable source of exclusive source of
whole-body causal whole-body causal
knowledge to build a knowledge to build a
virtual patient. human body.
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Our Advantage
The pharma industry’s best knowledge graphs are just low-dimensional projections/
shadows of the genome knowledges extracted by embryogenesis and BioinvestGPT.
Industry-leading
biomedical BioinvestGPT
knoweldge graphs human-equivalent
(grounded in truth yet virtual patients that
prone to illusions of accurately capture
non-existing causation) real complex causal
relationships in
human body.
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Data-Independent Head-to-Head Virtual Clinical Trials
Prior data independence makes BioinvestGPT super-reliable when it runs complex head-to-head
virtual clinical trials for first-in-class assets with > 92% ex-ante validated prediction accuracy.
Inputs Drug MoA Trial Design
(MNPI-free public source, prior
clinical data not necessary) Drug Target Indication
Target Modulation Inclusion/Exclusion Criteria
Drug Modality Primary Endpoints
Drug Delivery Secondary Endpoints
Mono/Combo-therapy Control Type
Treatment Type Trial Phase
Simulation
(virtual clinical trials) BioinvestGPT
Outputs
(actionable and compliant
Technical Clinical Prediction Commercial Clinical Prediction
recommendation for making
(whether primary/secondary endpoints could be (whether clinical benefits are superior over
investment decisions)
met with statistical significance) competitors for commercial successes)
BioinvestGPT predicts the concrete clinical benefits (not probability of success) for novel
FIC/BIC assets from Preclinical to Phase 3 without needing prior data as inputs.
Preclinical-Stage Novel Assets Clinical-Stage Novel Assets
No need of any prior clinical data as inputs No need of any prior clinical data as inputs
(which is also unavailable at preclinical stages)
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Workflow
All the necessary design parameters All the initial job requests from different BioinvestGPT will simulate placebo- Clinical prediction packages will
required for a clinicaltrials.gov study teams could be aggregated into a controlled and active-controlled be delivered as attachments via
record should be specified in job centralized database and further virtual Phase 3 clinical trials for each encrypted email to the point of
requests to meet the following needs: consolidated and confirmed by a received job request, in order to contact.
steering committee as the point of generate:
Portfolio Team select clinical candidates contact.
Technical Clinical Prediction
Partnering Team source external deals The final job requests can be prepared Whether key study endpoints (efficacy
and submitted to BioinvestGPT as and toxicity) will be met with statistical
attachments via encrypted emails. significance.
Alternatively, cloud-based access to the
Commercial Clinical Prediction
final job requests can be granted to
BioinvestGPT. Whether clinical benefits are
superior/non-inferior/inferior to
competing drugs and/or SoC treatments.
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Capacity
Indication
By running hundreds of BioinvestGPT phase III head-to-head virtual clinical
Modality
trials in 2025 (each takes 1-7 days), BioinvestGPT’s capacity is sufficient to
meet the needs of both the portfolio team for selecting internal clinical Delivery
candidates and the partnering team for sourcing external deals, such that
Combotherapy
92% of BioinvestGPT-recommended GO decisions could lead to blockbuster
drug launches and 98% of BioinvestGPT-recommended NO-GO decisions Stratification
could prevent costly investments in future underperforming drugs.
Control Arm
...
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BioinvestGPT Leadership
BioinvestGPT’s virtual clinical trial agents is 10x more than conventional clinical CROs.
2
Human Leaders
2,000,000+
Clinically Validated Human-equivalent Virtual Patients
(prospectively validated via prior-to-readout data-independent simulations
of 1800+ the most challenging human clinical trials sponsored by
biopharma companies globally)
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Early blockbuster drug discovery with
BioinvestGPT. 10x success rate at 10% R&D cost