Plus Therapeutics, Inc. (NASDAQ:PSTV) Q4 2020 Earnings Conference Call February 22, 2021 5:00 PM ET Company Participants Marc Hedrick - President and CEO Andrew Sims - CFO Conference Call Participants Emad Samad - Octaviant Ed Woo - Ascendiant Capital Operator Good afternoon, ladies and gentlemen. Welcome to the Plus Therapeutics Fourth Quarter and Full year 2020 Results Call. At this time, all participants have been placed in a listen-only mode, and the floor will be opened for your questions following the ...

[FORM 10-K Filing Information](index=1&type=section&id=FORM%2010-K) [Filing Details](index=1&type=section&id=Filing%20Details) This document is an Annual Report on Form 10-K for the fiscal year ended December 31, 2020, filed by **PLUS THERAPEUTICS, INC.** (formerly **Cytori Therapeutics, Inc.**), with common stock traded on the **Nasdaq Capital Market** under the symbol **PSTV** - The filing is an Annual Report on **Form 10-K** for the fiscal year ended **December 31, 2020**[2](index=2&type=chunk) - The registrant's name is **PLUS THERAPEUTICS, INC.**, previously known as **Cytori Therapeutics, Inc.**[2](index=2&type=chunk) Common Stock Trading Details | Title of each class | Trading Symbol(s) | Name of each exchange on which registered | | :------------------ | :---------------- | :---------------------------------------- | | Common Stock, par value $0.001 per share | PSTV | Nasdaq Capital Market | [Registrant Status](index=1&type=section&id=Registrant%20Status) The registrant is not a well-known seasoned issuer, is not required to file reports under Section 13 or 15(d) of the **Exchange Act**, has filed all required reports in the preceding **12 months**, and has submitted all Interactive Data Files, classified as a **Non-Accelerated Filer** and a **Smaller Reporting Company** - The registrant is not a **well-known seasoned issuer** and is not required to file reports pursuant to Section **13** or **15(d)** of the **Exchange Act**[3](index=3&type=chunk) - The registrant has filed all required reports during the preceding **12 months** and has submitted electronically every Interactive Data File[3](index=3&type=chunk) - The registrant is classified as a **Non-Accelerated Filer** and a **Smaller Reporting Company**[3](index=3&type=chunk) [Cautionary Statement Regarding Forward-Looking Statements](index=3&type=section&id=CAUTIONARY%20STATEMENT%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) This report contains forward-looking statements based on management's assumptions about future activities, events, and developments, subject to various risks and uncertainties including product candidate stages, clinical trial outcomes, liquidity, regulatory approvals, competition, and capital raising, with readers cautioned to review the "Risk Factors" section - The report contains forward-looking statements based on management's assumptions about future activities, events, or developments[8](index=8&type=chunk) - Actual results may differ materially due to factors such as the **early stage** of product candidates, **clinical trial uncertainties**, **liquidity**, **regulatory risks**, market conditions, and competition[9](index=9&type=chunk) - Readers are advised to carefully read the "**Risk Factors**" section and not to place undue reliance on forward-looking statements, which speak only as of the report date[10](index=10&type=chunk) [Risk Factor Summary](index=4&type=section&id=RISK%20FACTOR%20SUMMARY) This section summarizes principal factors that could adversely affect the company's business, financial condition, and results of operations, including recurring losses, the need for substantial additional funding, global capital market volatility, a "**going concern**" emphasis from auditors, and intense competition in the life science industry - The company has incurred losses since inception and expects significant net losses, potentially never becoming profitable[14](index=14&type=chunk) - Substantial additional funding is required for product development, future operations, and debt repayment; inability to secure funds may lead to delays or cessation of operations[14](index=14&type=chunk) - The audit report includes an emphasis paragraph regarding substantial doubt about the company's ability to continue as a "**going concern**"[14](index=14&type=chunk) [PART I](index=5&type=section&id=PART%20I) [Item 1. Business](index=5&type=section&id=Item%201.%20Business) **Plus Therapeutics** is a clinical-stage pharmaceutical company focused on developing innovative treatments for rare and difficult-to-treat cancers, particularly those of the central nervous system, leveraging a nanoscale drug development platform with **RNL™** as its lead candidate for recurrent glioblastoma, and a business strategy involving internal drug redesign, manufacturing, non-clinical analyses, early-stage clinical trials, and partnering for late-stage development and commercialization - **Plus Therapeutics** focuses on developing innovative treatments for rare and difficult-to-treat cancers, especially central nervous system cancers[16](index=16&type=chunk) - The company utilizes a **nanoscale drug development platform** and has an established, **GMP-validated R&D** and manufacturing facility in San Antonio, TX[17](index=17&type=chunk) - The business model includes market mapping, internal drug redesign, in-house manufacturing, non-clinical analyses, early-stage clinical trials, and partnering for late-stage development and commercial launch[18](index=18&type=chunk) [Pipeline](index=5&type=section&id=Pipeline) **Plus Therapeutics** has **four** investigational drugs, with **three** in clinical stages: **Rhenium NanoLiposomes (RNL™)** for recurrent glioblastoma (**rGBM**), **DocePLUS™** for solid tumors, and **DoxoPLUS™** for ovarian cancer, with **RNL™** as the lead candidate showing early efficacy signals in **Phase 1** trials and receiving **Orphan Drug** and **Fast Track** designations from the **FDA** - **Plus Therapeutics** has **four** investigational drugs, with **three** in clinical stages: **RNL™** (**recurrent glioblastoma**), **DocePLUS™** (**solid tumors**), and **DoxoPLUS™** (**ovarian cancer**)[19](index=19&type=chunk)[24](index=24&type=chunk) - **RNL™** is a patented radiotherapy for **recurrent glioblastoma**, currently in a **U.S. NCI-supported Phase 1 dose-finding clinical trial (ReSPECT™)**[24](index=24&type=chunk)[27](index=27&type=chunk) - **RNL™** has demonstrated early potential efficacy signals, with **two patients** surviving over **30 months** compared to a median of **9 months** for standard care, and received **FDA Orphan Drug** and **Fast Track designations** in **September 2020**[27](index=27&type=chunk)[28](index=28&type=chunk) [Licensing](index=6&type=section&id=Licensing) On **March 29, 2020**, **Plus Therapeutics** entered an exclusive license agreement with **NanoTx, Corp.** for global rights to develop and commercialize radiolabeled nanoliposomes, including **RNL™**, involving an upfront payment of **$400,000 cash** and **$300,000 in stock**, with potential future milestone payments up to **$136.5 million** and tiered single-digit royalties on **U.S.** and **European** sales, for technology developed by a multi-institutional consortium and supported by an active **$3M NIH/NCI award** - **Plus Therapeutics** licensed radiolabeled nanoliposome technology, including **RNL™**, from **NanoTx, Corp.** on **March 29, 2020**, for global development and commercialization[29](index=29&type=chunk)[32](index=32&type=chunk) NanoTx License Agreement Terms | Payment Type | Amount | | :------------- | :----- | | Upfront Cash | $400,000 | | Upfront Equity | $300,000 | | Potential Development & Sales Milestones | Up to $136.5 million | | Royalties | Tiered single-digit on U.S. and European sales | - The licensed technology was developed by a **Texas-based multi-institutional consortium** and is supported by an active **$3M NIH/NCI award** for **RNL's** clinical development[33](index=33&type=chunk) [Manufacturing](index=7&type=section&id=Manufacturing) The company operates a dedicated nanoparticle **R&D** and commercial-scale manufacturing facility in San Antonio, Texas, designed to comply with **cGMP** for drug candidates, enabling cost-effective production and process control, and also entered a **Master Services Agreement** with **Piramal Pharma Solutions, Inc.** in **January 2021** for the development, manufacture, and supply of **RNL-Liposome Intermediate Drug Product** - **Plus Therapeutics** has a dedicated nanoparticle **R&D** and commercial-scale manufacturing facility in San Antonio, Texas, compliant with **cGMP** for drug candidates[34](index=34&type=chunk) - The facility enables cost-effective drug substance production and control over the manufacturing process[34](index=34&type=chunk) - A **Master Services Agreement** was signed with **Piramal Pharma Solutions, Inc.** on **January 8, 2021**, for the development, manufacture, and supply of **RNL-Liposome Intermediate Drug Product**[34](index=34&type=chunk) [Competition](index=7&type=section&id=Competition) **Plus Therapeutics** competes based on the safety and efficacy of its therapies, brand, pricing, clinical data, regulatory approvals, and reimbursement, with success dependent on developing platforms, advancing clinical programs, securing approvals, expanding commercial footprint, producing high-quality products, achieving economies of scale, protecting **IP**, retaining talent, and executing partnerships, while **RNL™** faces competition in **recurrent glioblastoma** from numerous companies with drug development programs at various clinical stages - Competition is based on safety, efficacy, brand, pricing, clinical data, regulatory approvals, and reimbursement[35](index=35&type=chunk) - Success depends on developing platforms, advancing clinical programs, securing regulatory approvals, expanding commercial footprint, producing high-quality products, achieving economies of scale, protecting intellectual property, hiring/retaining talent, and executing partnerships[36](index=36&type=chunk) - **RNL™** faces competition in **recurrent glioblastoma** from numerous companies including **Bayer**, **VBL Therapeutics**, **Kintara Therapeutics**, and **Novartis**, all with drug development programs at various clinical stages[35](index=35&type=chunk) [Intellectual Property](index=8&type=section&id=Intellectual%20Property) The company's success relies on protecting its proprietary technology through patents, trade secrets, copyrights, trademarks, and confidentiality agreements, with **RNL™** covered by **U.S. Patent No. 7,718,160** (expiring **December 2026**, potential **5-year extension**) and a provisional application (filed **November 2020**, potential expiry **2041**) for methods of use, while **DocePLUS** is covered by **U.S. Patent No. 7,179,484** (expiring **April 2

Corporate Presentation January 2021 Forward-Looking Statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statement in this document that is not a historical fact is a "forward-looking statements" within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act and are usually identified by the use of words such as "anticipates," "believes," "estimates," "expects," "intends," "may ...

Financial Data and Key Metrics Changes - As of September 30, 2020, cash and cash equivalents decreased to $7.6 million from $17.6 million as of December 31, 2019 [12] - The company reported no revenues in Q3 2020, down from $4.8 million in the same period last year, attributed to the closeout of BARDA contracts [12] - Net loss for Q3 2020 was $1.7 million, compared to a net income of $0.5 million in Q3 2019, primarily due to a $7 million loss from discontinued operations in 2019 [16] Business Line Data and Key Metrics Changes - Research and development expenses were $0.3 million in Q3 2020, down from $0.9 million in Q3 2019, with a total of $1.6 million for the nine months ended September 2020 compared to $3.6 million in the same period in 2019 [13] - Sales and marketing expenses remained approximately $0.1 million in Q3 2020, unchanged from the previous year [14] - General and administrative expenses were $1 million for Q3 2020, unchanged from the same period last year, while for the nine months ended September 30, 2020, G&A was $3.8 million compared to $3.3 million in 2019 [15] Market Data and Key Metrics Changes - The FDA granted Orphan designation and Fast Track designation for RNL for the treatment of patients with recurrent glioblastoma during Q3 2020 [8] Company Strategy and Development Direction - The company is focused on advancing the development of RNL, with plans to complete enrollment in the ReSPECT trial by year-end 2020 and to report updated dataset enrollment progress at the Society for Neuro-Oncology meeting in mid-November [18] - The company is exploring additional clinical development programs for RNL, including indications such as leptomeningeal carcinomatosis, peritoneal carcinomatosis, and recurrent head and neck cancer [11] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the enrollment pace for Cohort 6 of the ReSPECT trial, citing corporate resources and partnerships with institutions like NCI as factors contributing to accelerated progress [32] - The company is awaiting specifics on potential funding opportunities from the state Cancer Fund, which could support RNL's development for additional indications [33] Other Important Information - The company announced the formation of a Clinical Advisory Board to support the development of RNL, consisting of experts in neurosurgery and neuro-oncology [7] - The company is actively manufacturing the drug for ReSPECT and is working on proper manufacturing controls and capabilities for late-stage clinical trials [19] Q&A Session Summary Question: Will overall survival data be provided at the upcoming meeting? - Yes, overall survival data will be provided, but it will include patients who have been recently treated and still alive, making it a blend of data [22] Question: Are alternative trial approaches being considered for RNL's registration study? - Yes, the company is considering synthetic controls and other trial approaches in discussions with the FDA, given the lack of approved treatments in the recurrent setting for nearly a decade [24] Question: What is the timeline for Cohort 6 enrollment? - Enrollment for Cohort 6 is expected to be similar to previous cohorts, with an accelerating pace due to corporate resources and additional sites being onboarded [32] Question: Is there an update on funding from the state Cancer Fund? - The company is awaiting specifics on a potential RFP for funding, which could support RNL for recurrent glioblastoma and other indications [33] Question: Will the company produce all drugs in-house for future studies? - The company plans to manufacture the drug in-house but may outsource some work due to the unique nature of the drug and supply chain logistics [40]

Plus Therapeutics, Inc. (NASDAQ:PSTV) Q2 2020 Earnings Conference Call August 10, 2020 5:00 PM ET Company Participants Marc Hedrick - President and CEO Andrew Sims - CFO Conference Call Participants Robert LeBoyer - Ladenburg Thalmann Ed Woo - Ascendiant Capital Emad Samad - WBB Operator Good afternoon, ladies and gentlemen. Welcome to the Plus Therapeutics Second Quarter 2020 Earnings Results Call. At this time, all participants have been placed in a listen-only mode, and the floor will be open for your qu ...

Financial Data and Key Metrics Changes - The operating cash burn for Q1 2020 was approximately $1.5 million, a decrease from $3.3 million in Q1 2019, primarily due to discontinued operations and reduced operating expenses [27] - The net loss for Q1 2020 was $1.1 million, compared to a net loss of $3.2 million in Q1 2019, attributed to discontinued operations and changes in fair value of warrants [27] - Total revenues for Q1 2020 were $0.1 million, down from $0.7 million in Q1 2019, mainly due to the closeout of a government contract with BARDA [28] Business Line Data and Key Metrics Changes - Research and development (R&D) expenses in Q1 2020 were $0.9 million, down from $1.4 million in Q1 2019, due to decreased spending following the sale of the former Cell Therapy business [27] - Sales and marketing expenses remained consistent at approximately $0.1 million [28] - General and administrative (G&A) expenses increased to $1.5 million in Q1 2020 from $1.4 million in Q1 2019, driven by increased professional fees [28] Market Data and Key Metrics Changes - As of March 31, 2020, the company had $16.1 million in cash and $9.3 million in debt principal, with total liabilities at $20.8 million, down from $22 million at the end of 2019 [29] Company Strategy and Development Direction - The company aims to optimize the regulatory and clinical program for RNL for glioblastoma and plans to expand the Phase 1 trial from one to three sites [32] - The strategic focus includes leveraging non-dilutive funding sources and exploring additional indications for RNL, such as head and neck cancer and leptomeningeal carcinomatosis [41][42] - The company is committed to a disciplined approach in assessing new pipeline enhancement opportunities while focusing resources on RNL development [26][33] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's position, noting that there have been no significant supply chain interruptions and no material impact on results for fiscal year 2020 due to COVID-19 [7][29] - The company is optimistic about the potential of the newly licensed RNL technology to redefine treatment for brain cancer and other poorly met cancer indications [10][12] Other Important Information - The company received a modest PPP loan approval but chose not to participate, citing its ability to operate normally during the pandemic [8] - The company donated personal protective equipment to frontline healthcare workers during the pandemic [9] Q&A Session Summary Question: Can you provide details on the Phase 1 trial enrollment? - The company has enrolled 13 patients so far and is currently treating the first patient in the fifth cohort, with plans to enroll between six to eight patients per cohort [36] Question: What outcomes are being measured in the Phase 2 trial? - The focus will be on survival as an outcome, with potential for exploring surrogate endpoints to expedite the clinical path [37] Question: Are there discussions with the FDA regarding fast track or orphan designation? - The company has not yet communicated with the FDA but considers it a priority to explore these designations [38] Question: What other indications are being considered for RNL? - Potential indications include head and neck cancer and leptomeningeal carcinomatosis, with ongoing analysis to determine the most promising opportunities [40][41] Question: Will the company focus on multiple indications simultaneously? - The company anticipates focusing on at least one additional indication, depending on capital availability and agency requirements [43] Question: Is the funding for RNL through the National Cancer Institute already secured? - Yes, the funding has been awarded and will be disbursed over time as the project progresses [46][47] Question: What is the current status of partnerships for DoxoPLUS and DocePLUS? - The company is seeking partnerships but has not yet found the right deal, focusing resources primarily on the RNL program [48] Question: How is the company's cash position for future operations? - The company has approximately 12 to 18 months of cash balance without raising additional capital, depending on the speed of RNL development [51]

Plus Therapeutics, Inc. (NASDAQ:PSTV) Q4 2019 Results Conference Call March 30, 2020 5:00 PM ET Company Participants Dr. Marc Hedrick - President and CEO Andrew Sims - CFO Conference Call Participants Ed Woo - Ascendiant Operator Good afternoon, ladies and gentlemen. Welcome to the Plus Therapeutics Fourth Quarter and Full Year 2019 Earnings Results Call. At this time, all participants have been placed in a listen-only mode, and the floor will be open for questions following the presentation. [Operator Inst ...

Delivering More For Patients Positively Impacting Healthcare Marc Hedrick, MD President & CEO Nasdaq: PSTV Biotech Showcase January 14, 2020 Forward-Looking Statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are based on our management's current beliefs, expectations and assumptions about future events, conditions and results and on information currently available to us. All statements, other than stat ...

Plus Therapeutics, Inc. (NASDAQ:PSTV) Q3 2019 Earnings Conference Call November 14, 2019 5:00 PM ET Company Participants Dr. Marc Hedrick - President and Chief Executive Officer Desiree Smith - Corporate Controller and Principal Accounting Officer Conference Call Participants Emad Samad - WBB Operator Good afternoon, ladies and gentlemen. Welcome to the Plus Therapeutics Investor Conference Call. At this time, all participants have been placed in a listen-only mode and the floor will be open for questions f ...

Cytori Therapeutics, Inc. (CYTX) Q4 2018 Results Earnings Conference Call April 1, 2019 8:30 AM ET Company Participants Marc Hedrick - President and Chief Executive Officer Tiago Girão - Chief Financial Officer, Outgoing Gary Titus - Chief Financial Officer, Incoming Conference Call Participants Jason McCarthy - Maxim Group Yale Jen - Laidlaw & Company Operator Good afternoon, ladies and gentlemen. Welcome to the Cytori Therapeutics Fourth Quarter and Full Year 2018 Earnings Results Call. At this time, all ...