Actuate Therapeutics, Inc. · NASDAQ:ACTU
Actuate Therapeutics — IPO Roadshow (July 2024)
27 slides from Actuate Therapeutics's IPO roadshow presentation, Jul 23, 2024
Slide 1: Corporate Overview July 2024
0 CORPORATE OVERVIEW July 2024 Issuer Free Writing Prospectus dated July 23, 2024 Filed Pursuant to Rule 433 of the Securities Act 1933, as amended Relating to Preliminary Prospectus dated July 23, 2024 Registration Statement No. 333-279734
Slide 2: Legal Disclaimer
1 Legal Disclaimer Actuate Therapeutics, Inc. (the "Company," "Actuate," "we," "our" and "us") has filed a registration statement (including a preliminary prospectus) on Form S-1 (File No. 333-279734) related to this proposed initial public offering with the Securities and Exchange Commission (the "
Slide 3: Forward-Looking Statements
2 Forward-Looking Statements This presentation contains forward-looking statements. Forward-looking statements are not historical facts but are based on certain assumptions of our management, which we believe to be reasonable but are inherently uncertain, and describe our future plans, strategies an
Slide 4: Transaction Overview
3 Transaction Overview Issuer Actuate Therapeutics, Inc. (Nasdaq: ACTU) Transaction Type Initial Public Offering Anticipated Offering Size $26.6 million (+15% Over-allotment Option) Securities Offered 2,950,000 Shares of Common Stock Price Range $8.00 - $10.00 per Share Use of Proceeds For clinical
Slide 5: Company Highlights
4 Company Highlights 1 Developing elraglusib, a leading GSK-3β inhibitor with novel, multimodal MOA, in multiple advanced cancer Phase 2 trials 4 Oral version of elraglusib successfully evaluated in Healthy Volunteer Phase 1 ▶ Potentially expands clinical and commercial opportunities 3 Extended surv
Slide 6: Multimodal MOA Supported by Clinical Data
5 • Elraglusib is an ATP-competitive inhibitor of GSK-3β • GSK-3β has been shown to potentially contribute to tumor progression in many treatment naive and refractory/resistant tumors • Pleiotropic effects as signaling adaptor • Elraglusib downregulates well-credentialed molecular pathways that can
Slide 7: Multimodal MOA Supported by Clinical Data: Clinical Studies
6 Note: As of May 2024 Multimodal MOA Supported by Clinical Data Elraglusib Injection Elraglusib Oral Tablet Pediatric Adult Actuate-1801 Pediatric Actuate-1902 Adult Actuate-2401 Part 3B: Pancreatic Cancer (combined with GnP) 1st line metastatic (randomized, controlled) Fast track designation Part
Slide 8: Actuate-1801 Clinical Study Design
7 Establishes process for transition from elraglusib (9-ING-41) Monotherapy (Part 1) to evaluation of multiple chemotherapy combinations (Part 2) to Phase 2 efficacy studies (Part 3) under one protocol Elraglusib + Gemcitabine Elraglusib + Doxorubicin Elraglusib + Carboplatin Elraglusib + Lomustine
Slide 9: Treatment-Emergent Adverse Events in Actuate 1801
8 As Monotherapy and in combination with chemotherapy Treatment-Emergent Adverse Events of Any Grade Reported in 20% of Patients Treated with elraglusib in Actuate 1801 Part 1 and 2 Treatment-Emergent Adverse Events of Any Grade Reported in 20% of Patients Treated with elraglusib (December 31, 2023)
Slide 10: Phase 2 Actuate 1801 Part 3A
9 Phase 2 – Actuate 1801 Part 3A • Simon’s two-stage design - Stage 1 • 1 st line metastatic pancreatic cancer (mPDAC) • Evaluate combination of elraglusib and gemcitabine/nab-paclitaxel (GnP) • First 23 consecutively evaluable patients defined as analysis set n= 29 after replacing non-evaluable pat
Slide 11: Phase 2 RCT in First-Line Metastatic PDAC
10 Phase 2 RCT • Primary endpoint: OS • Secondary endpoints: ORR, DOR, PFS • Total enrollment: 286 (completed Jan 2024) • Sample size based on increase in 1 year OS from 35% in GnP to 55% in elraglusib/GnP with α=0.05; 232 patients needed for 80% power Predefined Safety Population Draft unaudited da
Slide 12: Survival Swim Plots
11 Phase 2 RCT in First-Line Metastatic PDAC Survival Swim Plots Predefined Safety Population Draft unaudited data as of April 30, 2024 The final data and results may change as the study continues through completion GnP + weekly elra: n=155 47 on treatment, 53 events GnP: n=78 20 on treatment, 42 ev
Slide 13: Best Overall Response Waterfall Plots
12 Phase 2 RCT in First-Line Metastatic PDAC Best Overall Response Waterfall Plots Predefined Safety Population Draft unaudited data as of April 30, 2024 The final data and results may change as the study continues through completion
Slide 14: Time on Treatment Swim Plots
13 Predefined Safety Population Draft unaudited data as of April 30, 2024 Phase 2 RCT in First-Line Metastatic PDAC Time on Treatment Swim Plots GnP | n=78 (12 PRs) GnP + weekly elra | n=155 (32 PRs) The final data and results may change as the study continues through completion
Slide 15: Patient Demographics
14 Predefined Safety Population Draft unaudited data as of April 30, 2024 Patient Demographics as of May 1, 2024 Demographics – 1801 3B GnP (N = 78) 9-ING-41 (1x/wk) + GnP (N=155) Sex Female 35 (44.9%) 75 (48.4%) Male 43 (55.1%) 80 (51.6%) Age (years) n (%) 78 (100%) 155 (100%) Mean (S.D.) 66.0 (9.9
Slide 16: Elraglusib Monotherapy in Metastatic Melanoma
15 • Actuate 1801 Part 1 evaluated elraglusib as a single agent • Extraordinary results for two melanoma patients in the study • First objective response reported in patient treated with 5 mg/kg elraglusib monotherapy • Metastatic melanoma diagnosed in 2018; widely metastasized to the brain, lungs,
Slide 17: Actuate-1902 Ewing Sarcoma Results
16 • Seven patients were enrolled in Actuate-1902 and appear to have metastatic, refractory Ewing and Ewing-like sarcoma and had disease progression on their last treatment regimen prior to joining the study • All seven patients received the combination of elraglusib+cyclophosphamide/topotecan in 19
Slide 18: Single Agent Dose Escalation Actuate-1801 Part 1
17 • Single agent dose escalation (Actuate-1801 Part 1) was evaluated in 67 patients in 15 different cancer types1 • 35/67 subjects were enrolled at the three highest doses (9.4, 12.4 and 15 mg/kg) • Patients were advanced, refractory patients that had been heavily pre-treated [median 3 (1-13)] • A
Slide 19: Elraglusib Injection Pharmacokinetics
18 • Range of clinical benefit for elraglusib injection is hypothesized at 5 mg/kg and above based on PK data in patients1 • Exceeds in vitro IC50 for tumor cell line death/apoptosis in pre-clinical studies for >12 hours • These doses lead to plasma exposure of elraglusib of up to 87,850 ng•h/mL Dos
Slide 20: Elraglusib Oral Formulations
19 • Several possible oral dosage forms may allow potential expansion into pediatric cancer indications and adult indications where standard of care is oral • May improve compliance and patient experience in indications where long DCR is observed • Decreased cost of manufacturing at commercial scale
Slide 21: Elraglusib Oral Tablet Plasma Exposure
20 Elraglusib Oral Tablet Plasma Exposure (AUC) at MTD is similar to the Highest Dose of elraglusib Injection tested to date Route Potency Dose Number Target Dose (mg/kg) Actual Dose (mg/kg) Half-life (hr) Tmax (hr) Cmax (ng/mL) AUClast (hr*ng/mL) Dose-limiting Toxicity IV N/A 1 10 10 2.63 0.0830 6,
Slide 22: Key Near Term Anticipated Development Plans and Milestones
21 IV Program Part 3A paper ODD PDAC EMA / COMP FDA Type D Topline data Phase 2 mPDAC Request Type B Meeting to discuss EWS AA/BTD ODD EWS EMA / COMP EMA advice meeting (PDAC) 2024 July August October November December 2025 2H 2025 Key Near Term Anticipated Development Plans and Milestones 1H 2025 P
Slide 23: Intellectual Property: Composition of Matter Patents
22 9-ING-41 Polymorph I Composition of Matter: Patent Issued (10/5/2021) US 11,136,334 Patent Application No. PCT/US2018/046203, filed August 10, 2018 Expires August 10, 2038, Potentially Eligible for Patent Term Extension (PTE) Claims directed to Polymorph I, compounds, pharmaceutical compositions,
Slide 24: Capitalization
23 Capitalization As of March 31, 2024 Pre-IPO Cap Table (as converted, assumes $9.00 offering price and 1:1.8 reverse split) Common Stock 16,215,937(1) Warrants (WAEP: $10.32) 94,599 Options (WAEP: $2.97) 393,346 Fully Diluted Shares Outstanding 16,703,882 1) Includes the conversion of all outstand
Slide 25: Management Team
24 Andrew Mazar, PhD – Chief Operating Officer and Scientific Co-Founder • Co-founder, Chief Scientific Officer and Director, Monopar Therapeutics, Inc. (Nasdaq: MNPR) • Entrepreneur-in-Residence; Professor of Pharmacology; Founding Director, Center for Developmental Therapeutics, Northwestern Unive
Slide 26: Investment Highlights
25 Leading Therapeutic Profile Extensive data on activity from leading research institutions and promising clinical data in multiple cancer histologies Investment Highlights Significant Unmet Needs Developing elraglusib to address therapeutic shortcomings in key difficult-to-treat and refractory tum
Slide 27: Actuate
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