Actuate Therapeutics, Inc. · NASDAQ:ACTU
Actuate Therapeutics — IPO Roadshow (June 2024)
25 slides from Actuate Therapeutics's IPO roadshow presentation, Jun 11, 2024
Slide 1: Corporate Overview June 2024
0 CORPORATE OVERVIEW June 2024 Issuer Free Writing Prospectus dated June 10 , 2024 Filed Pursuant to Rule 433 of the Securities Act 1933 , as amended Relating to Preliminary Prospectus dated June 10 , 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 p rel iminary prospectus) on Form S - 1 (File No. 333 - 279734) related to this proposed initial public offering with the Securities and Exchange Commission
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 cert ain assumptions of our management, which we believe to be reasonable but are inherently uncertain, and describe our future plans, strate
Slide 4: Transaction Overview
3 Transaction Overview Actuate Therapeutics, Inc. (Nasdaq: ACTU) Initial Public Offering $50.0 million (+15% Over - allotment Option) 5,555,556 Shares of Common Stock $8.00 - $10.00 per Share For clinical trials and product development, research and development, clinical manufacturing as well as for
Slide 5: Company Highlights
4 Company Highlights 1 Developing elraglusib , a leading GSK - 3 β inhibitor with novel, multimodal MOA, in multiple advanced cancer Phase 2 trials 4 Oral version of elraglusib successfully evaluated in Healthy Volunteer Phase 1 ▶ Phase 1 dose escalation study planned in advanced cancer patients in
Slide 6: Multimodal MOA Supported by Clinical Data
5 • Elraglusib is an ATP - competitive inhibitor of GSK - 3 β • GSK - 3 β 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
Slide 7: Multimodal MOA Supported by Clinical Data
6 Note: As of May 202 4 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 designati
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 + Lomust
Slide 9: Treatment-Emergent Adverse Events with Elraglusib
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, 2
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 - eva
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
Slide 12: Phase 2 RCT Best Overall Response Waterfall Plots
11 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 13: Elraglusib Monotherapy in Melanoma
12 • 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 14: Actuate-1902 Ewing Sarcoma Results
13 • 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
Slide 15: Single Agent Dose Escalation Part 1
14 • Single agent dose escalation (Actuate - 1801 Part 1) was evaluated in 67 patients in 15 different cancer types 1 • 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
Slide 16: Elraglusib Injection Pharmacokinetics
15 • Range of clinical benefit for elraglusib injection is hypothesized at 5 mg/kg and above based on PK data in patients 1 • 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
Slide 17: Elraglusib Oral Formulations
16 • 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 18: Elraglusib Oral Tablet Plasma Exposure
17 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 ) T max ( hr ) C max (ng/mL) AUC last ( hr *ng/mL) Dose - limiting Toxicity IV N/A 1 10 10 2
Slide 19: Key Near Term Anticipated Development Plans and Milestones: IV Program
18 IV Program Phase 2 PDAC RCT Completion of enrollment. Part 3A paper ODD & Fast Track Ewing (EWS) EMA PRIME FDA Type D PFS in >80% / OS in 70% of control patients PDAC Topline data EWS PFS in 70% of control patients. 1902 Phase 2 amendment completed to focus on Ewing Request Type B Meeting to disc
Slide 20: Key Near Term Anticipated Development Plans and Milestones: Oral Program
19 Key Near Term Anticipated Development Plans and Milestones Oral Program GMP manufacturing of 250 mg Tablets Initiation of Phase 1 dose escalation trial, adult (AUS) Phase 2 Refractory MM Phase 2 study GMP Release of Tablets PK results from Phase 1 Phase 2 Refractory CRC / NSCLC Phase 2 studies (f
Slide 21: Intellectual Property Portfolio
20 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 compositi
Slide 22: Capitalization
21 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 16,211,835 (1) Warrants (WAEP: $10.32) 94,599 Options (WAEP: $2.97) 393,346 Fully Diluted Shares Outstanding 16,699,780 1) Includes the conversion of all outst
Slide 23: Management Team
22 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, Northweste
Slide 24: Investment Highlights
23 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
Slide 25: Actuate
ACTUATE HER A P/E U Bil Gas