8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

December 17, 2020

(Date of the earliest event reported)

Simulations Plus, Inc.

(Exact name of registrant as specified in its charter)

California	001-32046	95-4595609
(State or other jurisdiction<br>of incorporation)	(Commission File Number)	(I.R.S. Employer Identification No.)

42505 10^th^ Street West, Lancaster, California 93534-7059

(Address of principal executive offices) (Zip Code)

661-723-7723

Registrant's telephone number, including area code

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

[_] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

[_] Soliciting material pursuant to Rule 14z-12 under Exchange Act (17 CFR 240.14a-12)

[_] Pre-commencement communications pursuant to Rule 14d-2(b) under Exchange Act (17 CFR 240.14d-2(b))

[_] Pre-commencement communications pursuant to Rule 13e-4(c) under Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, par value $0.001 per share	SLP	The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging Growth Company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 7.01	Regulation FD Disclosure

On December 17, 2020, Simulations Plus, Inc., a California corporation (the “Company”), conducted an investor webinar using the presentation attached hereto as exhibit 99.1 to this Current Report on Form 8-K. The presentation has also been posted to the Company’s website in the “Investors” section.

The information in this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed subject to the requirements of Item 10 of Regulation S-K, nor shall it be deemed incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, regardless of any general incorporation language in such filing. The furnishing of this information hereby shall not be deemed an admission as to the materiality of any such information.

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Forward-Looking Statements

This Current Report on Form 8-K (the "Report"), including the disclosures set forth herein, contains certain forward-looking statements that involve substantial risks and uncertainties. When used herein, the terms "anticipates," "expects," "estimates," "believes" and similar expressions, as they relate to us or our management, are intended to identify such forward-looking statements.

Forward-looking statements in this Report or hereafter, including in other publicly available documents filed with the Securities and Exchange Commission (the "Commission"), reports to the stockholders of the Company and other publicly available statements issued or released by us involve known and unknown risks, uncertainties and other factors which could cause our actual results, performance (financial or operating) or achievements to differ from the future results, performance (financial or operating) or achievements expressed or implied by such forward-looking statements. Such future results are based upon management's best estimates based upon current conditions and the most recent results of operations. These risks include, but are not limited to, the risks set forth herein and in such other documents filed with the Commission, each of which could adversely affect our business and the accuracy of the forward-looking statements contained herein. Our actual results, performance or achievements may differ materially from those expressed or implied by such forward-looking statements.

Item 9.01	Financial Statements and Exhibits

(d)       Exhibits

99.1	Investor presentation, dated December 17, 2020.

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

	SIMULATIONS PLUS, INC.
Dated: December 18, 2020	By:	/s/ Will Frederick
		Will Frederick<br>Chief Financial Officer

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Exhibit 99.1

OPCO Fireside Chat December 17, 2020 Nasdaq: SLP

2 With the exception of historical information, the matters discussed in this presentation are forward - looking statements that involve a number of risks and uncertainties . The actual results of the Company could differ significantly from those statements . Factors that could cause or contribute to such differences include but are not limited to : continuing demand for the Company’s products, competitive factors, the Company’s ability to finance future growth, the Company’s ability to produce and market new products in a timely fashion, the Company’s ability to continue to attract and retain skilled personnel, and the Company’s ability to sustain or improve current levels of productivity . Further information on the Company’s risk factors is contained in the Company’s quarterly and annual reports and filed with the Securities and Exchange Commission . Safe Harbor Statement

Modeling and Simulation in Pharma Drug Development Software: The most comprehensive and widely recognized set of tools for in silico drug development. Ongoing development and reinvestment to incorporate the latest science and ensure a seamless user experience. Services: Highly interactive collaboration with our renowned experts allows us to deliver results in timely fashion and ensures a top quality deliverable. • Regular interactions and frequent progress updates eliminate surprises and ensure relevance as the knowledge - base evolves • Synergies come from shared knowledge between client and consultant • We welcome involvement, participation, and input from stakeholders outside of M&S 3 NASDAQ: SLP

Our solutions inform the entire drug development process Discovery Phase 1 Phase 2 Phase 3 NDA Cheminformatics EOP2 Pre - NDA IND Pharmacometrics PBPK Preclinical Regulatory Interaction Post Approval Approval Cognigen | Lixoft DILIsym Services QSP/QST

Technology Overview: The Machine Learning / PBPK / QST(P) M arriage… Permeability, solubility vs. pH, pKa(s), logD vs. pH, Fup, blood:plasma ratio, tissue Kps, CLint, C L filt Local & systemic exposure, drug distribution, parent and metabolite levels, patient variability 5 Machine Learning Inputs for QST(P) Next - Gen IVIVE PBPK in Molecule Optimization (AIDD)

: By the numbers… 6 Peer - reviewed journal publications 73% 10% 6% 6% 6% % Revenue by Client Type Pharma/Biotech Generics CROs Chemicals Nonprofit % Revenue by Geography 49% 1% 23% 26% • GastroPlus® client base: ~160 commercial companies and >90 nonprofit organizations • >60 commercial companies license $100K+ • All major global regulatory agencies have access and reviewers trained on the platform • ~93% customer retention rate (fees)

Cosmetics Europe: Dermal model extensions Est. end date: 2QFY21 Clients Driving Software R&D: Funded Collaborations Large Pharma: Virtual BE trial simulator Est. end date: 2QFY21 FDA: Dermal model extensions Est. end date: 4QFY21 7 Themes: • Whole - body mechanistic absorption • Advanced formulations • Animal - >human translation • Population simulations • Virtual BE • Library screening/optimization • Peptide administration Large Pharma: Gut model extensions Est. end date: 2QFY21 FDA: Ocular model extensions Est. end date: 4QFY22 FDA: Oral cavity model extensions Est. end date: 4QFY23 Large Pharma: Peptide absorption Est. end date: 2QFY22 Large Pharma: Pulmonary model extensions Est. end date: 2QFY21

>70 Approved drug product applications supported by GastroPlus® simulations 8

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Manufacturing Process Changes and Virtual Bioequivalence (BE) Trials to Waive Clinical Studies • Objective: build a PBPK model for an approved drug using existing clinical data for non - engineered formulations (NFE) and perform virtual BE trial simulations vs. the particle engineered (PE) lots to waive the BA/BE study request by the FDA • Simulation strategy presented describing the assessment of drug product specifications and virtual BE • Results: baseline model adequately captured existing clinical data and successfully applied to establish product specifications for new PE lots • Impact: the FDA accepted the modeling results and granted Janssen the BA/BE study request Tistaert et al. AAPS Annual Conference 2015 9

PBPK Modeling of pH - Dependent DDIs and Meal Types on Alpelisib (PIQRAY®) • Objective: develop and verify PBPK model to predict the impact of different meal types and co - administration with pH modifiers on alpelisib (PIQRAY®) • Simulation strategy presented outlining evaluation of pivotal clinical formulation (PCF) vs. commercial formulation (CF) under different conditions • Results: model successfully captures dosing with food and outcome of clinical bioequivalence (BE) studies • Impact: model results submitted with NDA; serves as foundation for future BE evaluations/pH - mediated DDI assessments and supports drug labeling Gajewska et al. AAPS J. 2020 10

Establish Dissolution Safe Space in Adult and Pediatric Populations (TAMIFLU®) 11 • Objective: develop and verify PBPK model to predict the exposure of oseltamivir (TAMIFLU®) and its main metabolite in adult and pediatric populations • Simulation strategy presented model development in adults and extrapolation to pediatrics at different age groups • Results: model successfully captures active and metabolite exposure across population groups and defines dissolution safe spaces unique to each one • Impact: previous model supported dose selection and trial design in pediatrics; optimized model supports future manufacturing site/formulation changes and sets clinically relevant safe spaces in both adults and pediatrics. Miao et al. AAPS J. 2020

DILIsym Services Inc., an SLP Company • DILIsym Services, Inc. offers comprehensive program services: – DILIsym software licensing, training, development (consortia) – NAFLDsym and IPFsym software licensing, training, development – QSP / QST simulation consulting projects – Consulting and data interpretation; in vitro assay experimental design and management – RENAsym and RADAsym software in development “Our vision is safer, effective, more affordable medicines for patients through modeling and simulation.” 12

DILIsym Services Is Using QSP and QST Modeling to Predict Efficacy and Safety of Drugs in Development Exposure Drug Effects DILI Liver Biochemistry/ Pathophysiology Efficacy Mechanistic representation of underlying biochemistry describing pathophysiology is foundation of QSP models PD effects and interactions with underlying biochemistry unique for most compounds; QSP model needs to be flexible to provide ability to represent these effects Predicted compound concentrations at site of target often require PBPK models 13

NAFLDsym v2A Overview Multiple interacting sub - models, including • Steatosis • Lipotoxicity • Inflammation • Fibrosis • Biomarkers • Weight gain/loss Numerous simulated patients (SimPops) included to account for pathophysiologic and clinical heterogeneity Clinical data from literature used to establish quantitative relationships for underlying biochemistry Provides ability to predict responses to treatment in simulated clinical trials 14

Collaboration with Genentech Focused on Anti - FGFR1/KLB Antibody – Helped Them Determine the Mechanisms Responsible for a Drug Effect 15

How the DILIsym Software Helps Drug Developers • Predicts drug - induced liver disease • Includes mechanistic representation of normal hepatic biochemistry So how can DILIsym help my organization? • Predict DILI liabilities beforehand and save $$$ • Choose the lead candidate most likely to succeed from a DILI standpoint • Communicate with regulators on safety issues with information they have requested from others numerous times and from a platform they license (FDA) • Keep patients safer…. eDISH 16

DILIsym Utilizes Various Data Types to Inform Decisions • Dosing Protocols, fasting/fed state, meal times • Anthropometric data - Body weight, age, ethnicity • Pharmacokinetic data - Absorption, extra - hepatic clearance, metabolites PBPK Modeling • Compound Properties - Tissue partition coefficients • Tissue penetration studies - Liver to blood ratio • Pharmacokinetic data - Absorption, extra - hepatic clearance, metabolites • in vitro data - Metabolite synthesis, active uptake Modeling & Simulation In vitro Mechanistic DILI Data Clinical Information Assays performed to determine quantitative aspects of DILI mechanisms • Oxidative stress - Direct and reactive metabolite - mediated • Mitochondrial toxicity - ETC inhibition - Uncoupling • Bile acid / phospholipid transporter inhibition - BSEP, MRP3 and 4, NTCP, (MDR3) • Bilirubin transport/metabolism - OATP1B1, OATP1B3, UGT1A1, MRP2, MRP3 Exposure Data Simulations and Assays inform: • Prediction of DILI risk • Participating DILI mechanisms • Characteristics of patients at risk for DILI • Drug dosing paradigms • DILI monitoring strategies 17

Important DILIsym Application Examples NORMAL 18

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Q & A 22