PSTV PLUS THERAPEUTICS Inc.

2.12
-0.05  -2%
Previous Close 2.17
Open 2.12
52 Week Low 1.6
52 Week High 5.42
Market Cap $44,745,180
Shares 21,106,217
Float 21,063,803
Enterprise Value $38,455,490
Volume 265,656
Av. Daily Volume 1,418,380
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Drug Pipeline

Drug Stage Notes
DocePLUS (ATI-1123)
Platinum-sensitive small cell lung cancer
Phase 2
Phase 2
Phase 1 trial has completed.
Rhenium NanoLiposomes (ReSPECT)
Glioma
Phase 1/2
Phase 1/2
Phase 1 initial data presented at SNO Annual Meeting November 19, 2020.

Latest News

  1. AUSTIN, Texas, May 04, 2021 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing novel, targeted therapies for rare and difficult to treat cancers, today announced two collaboration agreements to support its process development and analytical chemistry activities for the cGMP manufacturing of Rhenium NanoLiposome (RNL™), the Company's lead investigational asset in clinical development for recurrent glioblastoma.

    Plus Therapeutics signed a pre-clinical, clinical, and process development agreement with Invicro LLC (Invicro), a Konica Minolta company, a global provider of imaging biomarkers, core lab services, advanced analytics and software solutions for drug discovery…

    AUSTIN, Texas, May 04, 2021 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing novel, targeted therapies for rare and difficult to treat cancers, today announced two collaboration agreements to support its process development and analytical chemistry activities for the cGMP manufacturing of Rhenium NanoLiposome (RNL™), the Company's lead investigational asset in clinical development for recurrent glioblastoma.

    Plus Therapeutics signed a pre-clinical, clinical, and process development agreement with Invicro LLC (Invicro), a Konica Minolta company, a global provider of imaging biomarkers, core lab services, advanced analytics and software solutions for drug discovery and development with best-in-class expertise in radiochemistry. Under this agreement, Invicro will characterize the current manufacturing process and develop in-process manufacturing controls for the RNL™ active pharmaceutical ingredient (API) and final drug product and provide future clinical trial imaging support and drug development consulting.

    In addition, Plus Therapeutics entered into an agreement with Eurofins BioPharma Inc. ("Eurofins"), a market leader in analytical chemistry for discovery pharmacology and advanced materials sciences. Eurofins will develop and validate test methods for purity, composition, and identity of Re-BMEDA, the API in RNL™. These test methods will support release testing and compliance with cGMP requirements for new drug substances.

    "Process optimization and appropriate quality controls of investigational compounds are very critical aspects in bringing novel drugs to markets," said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. "We have identified two best-in-class partners in Invicro and Eurofins to help us get one step further in bringing RNL to a registrational clinical trial and ultimately commercial supply."

    As previously disclosed, Plus Therapeutics entered into a master services agreement with Piramal Pharma Solutions for the development, manufacture, and supply of RNL™ intermediate of the drug product.

    About Plus Therapeutics, Inc.

    Plus Therapeutics (NASDAQ:PSTV) is a clinical-stage pharmaceutical company whose radiotherapeutic portfolio is concentrated on nanoliposome-encapsulated radionuclides for several cancer targets. Central to the Company's drug development is a unique nanotechnology platform designed to reformulate, deliver and commercialize multiple drugs targeting rare cancers and other diseases. The platform is designed to facilitate new delivery approaches and/or formulations of safe and effective, injectable drugs, potentially enhancing the safety, efficacy and convenience for patients and healthcare providers. More information may be found at PlusTherapeutics.com and ReSPECT-Trials.com.

    About Invicro, LLC.

    Headquartered in Boston, Mass., Invicro was founded in 2008 with the mission of improving the role and function of imaging in translational drug discovery and development across all therapeutic areas. Today, Invicro's multi-disciplinary team provides solutions to pharmaceutical and biotech companies across all stages of the drug development pipeline (Phase 0-IV), all imaging modalities and all therapeutic areas, including neurology, oncology, and systemic and rare diseases. Invicro's quantitative biomarker services, advanced analytics and AI tools, and clinical operational services are backed by Invicro's industry-leading software informatics platforms, VivoQuant® and iPACS®, as well as their pioneering IQ-Analytics Platform, which includes AmyloidIQ, TauIQ and DaTIQ.

    As part of the Konica Minolta precision medicine organization and with their sister company Ambry Genetics, Invicro develops and leverages the latest approaches in integrated diagnostics including imaging, quantitative pathology and genomics. For more information, visit www.invicro.com.

    About Eurofins BioPharma Inc.

    Eurofins is a group of international life sciences companies which provide a unique range of analytical testing services to clients across multiple industries. The Group is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies. In addition, Eurofins is one of the leading global emerging players in esoteric and molecular clinical diagnostic testing.

    Cautionary Statement Regarding Forward-Looking Statements

    This press release contains statements that may be deemed "forward-looking statements" within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as "will," "believe," "plan," "can," "enable," "design," "intend," "potential," "expect," "estimate," "project," "prospect," "target," "focus," "anticipate," "could," "should," and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the design and potential of the Plus Therapeutics portfolio to reformulate, deliver and commercialize multiple novel, proprietary drugs targeting rare cancers and other diseases and to facilitate new delivery approaches and/or formulations of safe and effective, injectable drugs; the potential of the Company's in-licensed portfolio of investigational drugs; the Company's intent to advance its CNS oncology portfolio through the clinical development process; the ability of RNL to safely, effectively and conveniently deliver a very high dose of radiation directly into the brain tumor; anticipated benefits of strategic collaborations and license agreements, intellectual property, FDA approval process and government regulation; and the Company's anticipated milestones and events, including with respect to additional sites, enrollment, pivotal trial planning, IND process, and clinical phase plans for RNL, pipeline expansion through additional drug development candidates, and partnership discussions for RNL, DocePLUS and DoxoPLUS; and future development and/or expansion of its product candidates and therapies in its markets. The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that the Company is not able to successfully develop product candidates that can leverage the FDA's accelerated regulatory pathways; the early stage of the Company's product candidates and therapies, the results of its research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company's history of losses; the Company's need for, and ability to raise, additional cash or obtain other sources of funding in the immediate future; the Company's ability to: (a) obtain and maintain regulatory approvals, (b) continue as a going concern, (c) remain listed on the Nasdaq Capital Market, (d) to obtain or maintain sufficient levels of reimbursement for its tests, and (d) to repay or refinance some or all of its outstanding indebtedness; the outcome of the Company's partnering/licensing efforts; market and economic conditions; the impact of the COVID-19 pandemic on the Company and the effectiveness of the efforts it has taken or may take in the future in response thereto; and additional risks described under the heading "Risk Factors" in the Company's Securities and Exchange Commission filings, including in the Company's annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.

    Investor Contact

    Peter Vozzo

    Westwicke/ICR

    (443) 377-4767

    Media Contact

    Terri Clevenger

    Westwicke/ICR

    (203) 856-4326

     



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  2. AUSTIN, Texas, April 22, 2021 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing novel, targeted therapies for rare and difficult to treat cancers, today announced financial results for the first quarter ended March 31, 2021, and provided an overview of recent business highlights.

    The Company's lead investigational drug is Rhenium NanoLiposome (RNL™), a radiotherapy in development for several rare cancer targets, including recurrent glioblastoma (GBM). RNL™, currently being evaluated in the U.S. multi-center ReSPECT™ Phase 1 dose-finding clinical trial, is designed to safely, effectively, and conveniently deliver a very high dose of radiation directly to brain tumors.

    "In the first quarter of 2021, we made meaningful progress in critical areas including advancing our drug development and manufacturing activities, refining our clinical understanding of RNL™ behavior in the glioblastoma patients and in seeking FDA feedback on potential new clinical indications for RNL™," said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics.

    First Quarter 2021 Clinical Highlights

    Company highlights during the first quarter of 2021 included:

    • Entering into a master services agreement (MSA) with Piramal Pharma Solutions for the development, manufacture, and supply of RNL™ intermediate drug product.
    • Completing the 6th dose escalation cohort, with 18 patients treated in ReSPECT™, with concomitant increases in both RNL™ drug volume and radiation dose.
    • Beginning treatment in an expansion cohort at the 6th dose with higher drug flow rates and faster drug infusion times.
    • Submitting 2 RNL™ pre-IND meeting briefing packages to the U.S. Food and Drug Administration (FDA) for treatment of leptomeningeal metastases and pediatric brain cancers, specifically ependymoma, high-grade glioma, and diffuse intrinsic pontine glioma.

    Expected Upcoming Clinical Milestones and Events for 2021

    In upcoming quarters in 2021, the Company intends to focus on a number of additional business objectives and potential milestones:

    • Complete enrollment of the ReSPECT™ Phase 1 trial for RNL™ in recurrent glioblastoma.
    • Complete pivotal trial planning in conjunction with FDA feedback for RNL™ in recurrent glioblastoma.
    • Complete a pre-IND meeting with the FDA, execute IND-enabling studies, if needed, and move into clinical trials for new RNL™ indications.
    • Continue development and evaluation of additional external and internal drug development candidates to expand the drug development pipeline.
    • Continue to explore partnership opportunities for three clinical-stage investigational drugs: RNL™, DocePLUS™ and generic DoxoPLUS™.

    First Quarter 2021 Financial Results

    • As of March 31, 2021, the Company's cash balance was $14.4 million, compared to $8.3 million as of December 31, 2020.
    • Total operating expenses for the first quarter of 2021 was $2.5 million, compared to total operating expenses of $2.56 million for the same quarter in 2020.
    • Net loss for the first quarter of 2021 was $2.7 million, or $(0.33) per share, compared to a net loss of $1.1 million, or $(0.28) per share, for the same quarter in 2020. The net loss was consistent year on year when excluding the book gains on the warrants reported in Q1 2020. Remeasurement of warrant liabilities was no longer required for Series U warrants that were amended in Q2 and Q3 2020 and reclassified to equity.

    First Quarter 2021 Results Conference Call

    The Company will hold a conference call and live audio webcast at 5:00 p.m. Eastern Time today to discuss its financial results and provide a general business update.

    Event:Plus Therapeutics First Quarter 2021 Results Conference Call
    Date:Thursday, April 22, 2021
    Time: 5:00 p.m. Eastern Time
    Live Call: 877-402-3914 (toll free); 631-865-5294 (Intl.); Conference ID: 3084418 

    The webcast can be accessed live via the investor section of the Plus Therapeutics website at ir.plustherapeutics.com/events and will be available for replay beginning two hours after the conclusion of the conference call.

    About Plus Therapeutics, Inc.

    Plus Therapeutics (NASDAQ:PSTV) is a clinical-stage pharmaceutical company whose radiotherapeutic portfolio is concentrated on nanoliposome-encapsulated radionuclides for several cancer targets. Central to the Company's drug development is a unique nanotechnology platform designed to reformulate, deliver and commercialize multiple drugs targeting rare cancers and other diseases. The platform is designed to facilitate new delivery approaches and/or formulations of safe and effective, injectable drugs, potentially enhancing the safety, efficacy and convenience for patients and healthcare providers. More information may be found at PlusTherapeutics.com and ReSPECT-Trials.com.

    Cautionary Statement Regarding Forward-Looking Statements

    This press release contains statements that may be deemed "forward-looking statements" within the meaning of U.S. securities laws. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as "will," "believe," "plan," "can," "enable," "design," "intend," "potential," "expect," "estimate," "project," "prospect," "target," "focus," "anticipate," "could," "should," and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements regarding the following: the design and potential of the Plus Therapeutics portfolio to reformulate, deliver and commercialize multiple novel, proprietary drugs targeting rare cancers and other diseases and to facilitate new delivery approaches and/or formulations of safe and effective, injectable drugs; the potential of the Company's in-licensed portfolio of investigational drugs; the Company's intent to advance its CNS oncology portfolio through the clinical development process; the ability of RNL to safely, effectively and conveniently deliver a very high dose of radiation directly into the brain tumor; anticipated benefits of strategic collaborations and license agreements, intellectual property, FDA approval process and government regulation; and the Company's anticipated milestones and events, including with respect to additional sites, enrollment, pivotal trial planning, IND process, and clinical phase plans for RNL, pipeline expansion through additional drug development candidates, and partnership discussions for RNL, DocePLUS and DoxoPLUS; and future development and/or expansion of its product candidates and therapies in its markets.   The forward-looking statements included in this press release are subject to a number of risks and uncertainties that may cause actual results to differ materially from those discussed in such forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that the Company is not able to successfully develop product candidates that can leverage the FDA's accelerated regulatory pathways; the early stage of the Company's product candidates and therapies, the results of its research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company's history of losses; the Company's need for, and ability to raise, additional cash or obtain other sources of funding in the immediate future; the Company's ability to: (a) obtain and maintain regulatory approvals, (b) continue as a going concern, (c) remain listed on the Nasdaq Capital Market, (d) to obtain or maintain sufficient levels of reimbursement for its tests, and (d) to repay or refinance some or all of its outstanding indebtedness; the outcome of the Company's partnering/licensing efforts; market and economic conditions; the impact of the COVID-19 pandemic on the Company and the effectiveness of the efforts it has taken or may take in the future in response thereto; and additional risks described under the heading "Risk Factors" in the Company's Securities and Exchange Commission filings, including in the Company's annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.

      
      
    PLUS THERAPEUTICS, INC.

    CONSOLIDATED CONDENSED BALANCE SHEETS

    (Unaudited)

    (in thousands, except share and par value data)
     
      
      March 31, 2021  December 31,

    2020
     
    Assets        
    Current assets:        
    Cash and cash equivalents $14,447  $8,346 
    Other current assets  999   829 
    Total current assets  15,446   9,175 
             
    Property and equipment, net  1,825   1,820 
    Operating lease right-of-use assets  600   636 
    Goodwill  372   372 
    Intangible assets, net  77   86 
    Other assets  16   16 
    Total assets $18,336  $12,105 
    Liabilities and Stockholders' Equity        
    Current liabilities:        
    Accounts payable and accrued expenses $1,716  $2,081 
    Operating lease liability  113   123 
    Term loan obligations, net of discount  6,486   6,335 
    Total current liabilities  8,315   8,539 
             
             
    Noncurrent operating lease liability  503   528 
    Warrant liability  5   7 
    Total liabilities  8,823   9,074 
             
    Stockholders' equity:        
    Preferred stock, $0.001 par value; 5,000,000 shares authorized; 1,952 and 1,954

    shares issued and outstanding at March 31, 2021 and December 31, 2020,

    respectively
          
    Common stock, $0.001 par value; 100,000,000 shares authorized; 10,180,525

    and 6,749,028 shares issued and outstanding at March 31, 2021 and December

    31, 2020, respectively
      10   7 
    Additional paid-in capital  445,734   436,535 
    Accumulated deficit  (436,231)  (433,511)
    Total stockholders' equity  9,513   3,031 
    Total liabilities and stockholders' equity $18,336  $12,105 
             



    PLUS THERAPEUTICS, INC.

    CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS

    (Unaudited)

    (in thousands, except share and per share data)
     
      For the Three Months Ended March 31, 
      2021  2020 
    Development revenues:        
    Government contracts and other $  $118 
    Operating expenses:        
    Research and development  1,127   941 
    General and administrative  1,352   1,618 
    Total operating expenses  2,479   2,559 
    Loss from operations  (2,479)  (2,441)
             
    Other income (expense):        
    Interest income  4   36 
    Interest expense  (247)  (349)
    Change in fair value of warrants  2   1,667 
    Total other income (expense)  (241)  1,354 
    Net loss $(2,720) $(1,087)
             
    Net loss per share, basic and diluted $(0.33) $(0.28)
    Basic and diluted weighted average shares used in calculating net loss per share

    attributable to common stockholders
      8,267,901   3,880,588 
             



    PLUS THERAPEUTICS, INC.

    CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS

    (Unaudited)

    (in thousands)
     
      For the Three Months Ended March 31,

      2021

     2020

    Cash flows used in operating activities:        
    Net loss $(2,720) $(1,087)
    Adjustments to reconcile net loss to net cash used in operating activities:        
    Depreciation and amortization  88   94 
    Amortization of deferred financing costs and debt discount  151   122 
    Noncash lease expenses  1   4 
    Change in fair value of warrants  (2)  (1,667)
    Share-based compensation expense  107   12 
    Increases (decreases) in cash caused by changes in operating assets and liabilities:        
     Accounts receivable     191 
     Other current assets  (170)  405 
     Other assets     14 
     Accounts payable and accrued expenses  (461)  410 
     Net cash used in operating activities  (3,006)  (1,502)
    Cash flows provided by (used in) investing activities:        
    Purchases of property and equipment  (84)  (11)
     Net cash used in investing activities  (84)  (11)
    Cash flows used in financing activities:        
    Payment of financing lease liability  (6)  (18)
    Proceeds from exercise of warrants  2,017    
    Proceeds from sale of common stock, net  7,180    
     Net cash provided by (used in) financing activities  9,191   (18)
     Net increase (decrease) in cash and cash equivalents  6,101   (1,531)
    Cash and cash equivalents at beginning of period  8,346   17,592 
    Cash and cash equivalents at end of period  14,447   16,061 
    Supplemental disclosure of cash flows information:        
    Cash paid during period for:        
     Interest $96  $227 
    Supplemental schedule of non-cash investing and financing activities:        
    Unpaid offering costs $102  $ 
             

    Investor Contact

    Peter Vozzo

    Westwicke/ICR

    (443) 377-4767

    Media Contact

    Terri Clevenger

    Westwicke/ICR

    (203) 856-4326



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  3. AUSTIN, Texas, April 08, 2021 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing novel, targeted and personalized therapies for rare and difficult to treat cancers, announced that the Company will report first quarter 2021 financial results on Thursday, April 22, 2021, after market close. Plus Therapeutics' management team will then host a conference call and webcast at 5:00 p.m. Eastern Time to discuss the financial results and provide a corporate update.

    A live webcast will be available at ir.plustherapeutics.com/events

    Please refer to the information below for conference call dial-in information. Callers should dial in approximately 10 minutes prior to…

    AUSTIN, Texas, April 08, 2021 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing novel, targeted and personalized therapies for rare and difficult to treat cancers, announced that the Company will report first quarter 2021 financial results on Thursday, April 22, 2021, after market close. Plus Therapeutics' management team will then host a conference call and webcast at 5:00 p.m. Eastern Time to discuss the financial results and provide a corporate update.

    A live webcast will be available at ir.plustherapeutics.com/events

    Please refer to the information below for conference call dial-in information. Callers should dial in approximately 10 minutes prior to the start of the call.

    Conference dial-in:877-402-3914
    International dial-in:631-865-5294
    Conference ID:3084418
    Conference Call Name:Plus Therapeutics First Quarter 2021 Results Conference Call

    Following the live call, a replay will be available on the Company's website under the 'Investor Relations' section. The webcast will be available on the Company's website for 90 days following the live call.

    About Plus Therapeutics, Inc.

    Plus Therapeutics (NASDAQ:PSTV) is a clinical-stage pharmaceutical company whose radiotherapeutic portfolio is concentrated on nanoliposome-encapsulated radionuclides for several cancer targets. Central to the Company's drug development is a unique nanotechnology platform designed to reformulate, deliver and commercialize multiple drugs targeting rare cancers and other diseases. The platform is designed to facilitate new delivery approaches and/or formulations of safe and effective, injectable drugs, potentially enhancing the safety, efficacy and convenience for patients and healthcare providers. More information may be found at PlusTherapeutics.com and ReSPECT-Trials.com.

    Cautionary Statement Regarding Forward-Looking Statements

    This press release contains certain statements that may be deemed "forward-looking statements" within the meaning of U.S. securities laws. All statements, other than statements of historical fact, that address activities, events or developments that we intend, expect, project, believe or anticipate and similar expressions or future conditional verbs such as will, should, would, could or may occur in the future are forward-looking statements. Such statements are based upon certain assumptions and assessments made by our management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements about: the Company's potential to facilitate new delivery approaches and/or formulations of safe and effective, injectable drugs, potentially enhancing the safety, efficacy and convenience for patients and healthcare providers; the Company's potential to develop drug candidates currently in its product pipeline; and the Company's potential to develop additional drugs outside of its current pipeline. The forward-looking statements included in this press release are subject to a number of additional material risks and uncertainties, including but not limited to: the risk that the Company is not able to successfully develop product candidates that can leverage the U.S. FDA's accelerated regulatory pathways; and the risks described under the heading "Risk Factors" in the Company's Securities and Exchange Commission filings, including in the Company's annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.

    Investor Contact

    Peter Vozzo

    Westwicke/ICR

    (443) 377-4767

    Media Contact

    Terri Clevenger

    Westwicke/ICR

    (203) 856-4326



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  4. MUMBAI, India, March 23, 2021 /PRNewswire/ -- Piramal Pharma Limited's (PPL) Contract Development and Manufacturing Organization (CDMO), Piramal Pharma Solutions (PPS), announced today that the Company has entered into a Master Services Agreement (MSA) with Plus Therapeutics, Inc. for Piramal to perform services related to the development, manufacture, and supply of Plus Therapeutics' RNL-Liposome Intermediate Drug Product.

    This MSA includes the transfer of analytical methods, development of microbiological methods, process transfer and optimization, intermediate drug product manufacturing, and stability studies. The transfer will be performed at the PPS drug product facility located in Lexington, Kentucky. The two Companies envision that the MSA will lead to clinical and commercial supply agreements for the drug product at the appropriate stage of development.

    PPS' Lexington site is recognized as a North American leader in the formulation, development and manufacturing of sterile parenteral drug products. The Lexington site has the capability to support drug development for New Chemical Entities (NCEs), generics, and molecules that might be following the 505(b)(2) regulatory pathway.

    Peter DeYoung, CEO, Pharma Solutions, Piramal Pharma Limited, stated that, "We are excited to partner with Plus Therapeutics. We believe that this represents the start of a long, collaborative and mutually beneficial relationship that will address our ultimate objective of reducing the burden of disease on patients."

    "This agreement represents another significant milestone for Plus, as we work to advance development of RNL as a novel treatment option for patients diagnosed with glioblastoma," said Marc Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. "The team at PPS has the knowledge, experience and expertise to support our needs, both now and in the future as we advance RNL towards regulatory approval."

    About Piramal Pharma Solutions:

    Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs and finished dosage forms. We also offer specialized services such as development and manufacture of highly potent APIs and antibody drug conjugation, sterile fill/finish with and without containment and potent solid oral drug product. Our capability as an integrated service provider & experience with various technologies enables us to serve innovator and generic companies worldwide.

    For more information and updates, please visit: www.piramalpharmasolutions.com | Social Media: Twitter, LinkedIn

    About Piramal Pharma Limited:

    Piramal Pharma Limited (PPL), a subsidiary of Piramal Enterprises Limited, offers a portfolio of differentiated products and services through end-to-end manufacturing capabilities across 14 global facilities and a global distribution network in over 100 countries. PPL includes: Piramal Pharma Solutions, an integrated Contract Development and Manufacturing Organization (CDMO); Piramal Critical Care, a complex hospital generics business; and the Consumer Healthcare business, selling over-the-counter products in India. In addition, PPL has a joint venture with Allergan, a leader in ophthalmology in the Indian formulations market. In October 2020, PPL received 20% strategic growth investment from the Carlyle Group.

    For more information and updates, please visit: www.piramal.com | Social Media: Facebook, Twitter, LinkedIn

    About Plus Therapeutics, Inc.

    Plus Therapeutics (NASDAQ:PSTV) is a clinical-stage pharmaceutical company whose radiotherapeutic portfolio is concentrated on nanoliposome-encapsulated radionuclides for several cancer targets. Central to the Company's drug development is a unique nanotechnology platform designed to reformulate, deliver and commercialize multiple drugs targeting rare cancers and other diseases. The platform is designed to facilitate new delivery approaches and/or formulations of safe and effective, injectable drugs, potentially enhancing the safety, efficacy and convenience for patients and healthcare providers. More information may be found at PlusTherapeutics.com and ReSPECT-Trials.com.

    Logo - https://mma.prnewswire.com/media/1425672/Piramal_Pharma_Solutions_Logo.jpg

    Investor Contact

    Peter Vozzo

    Westwicke/ICR

    +1-(443)-377-4767

    Media Contact

    Terri Clevenger

    Westwicke/ICR

    +1-(203)-856-4326

    For Piramal Pharma Media Queries:                                                                                  

    Dimple Kapur / Niyati Vora                                                                             

    Corporate Communications                                                                 

     /    

    For Piramal Pharma Investors                                                                     

    Hitesh Dhaddha/Mayank Kumar                                                                      

    Investor Relations                                                                             

     

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/piramal-pharma-solutions-enters-into-a-master-services-agreement-with-plus-therapeutics-inc-301254272.html

    SOURCE Piramal Pharma Solutions

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  5. AUSTIN, Texas, March 23, 2021 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing novel, targeted therapies for rare and difficult to treat cancers, today announced that it has entered into a master services agreement (MSA) with Piramal Pharma Solutions (PPS) for the development, manufacture, and supply of Plus' Rhenium NanoLiposome (RNL™) intermediate drug product.

    The MSA includes the transfer of analytical methods, development of microbiological methods, process transfer and optimization, intermediate drug product manufacturing and stability studies. The transfer will be performed at PPS's drug product facility in Lexington, Kentucky. Plus anticipates that the MSA…

    AUSTIN, Texas, March 23, 2021 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing novel, targeted therapies for rare and difficult to treat cancers, today announced that it has entered into a master services agreement (MSA) with Piramal Pharma Solutions (PPS) for the development, manufacture, and supply of Plus' Rhenium NanoLiposome (RNL™) intermediate drug product.

    The MSA includes the transfer of analytical methods, development of microbiological methods, process transfer and optimization, intermediate drug product manufacturing and stability studies. The transfer will be performed at PPS's drug product facility in Lexington, Kentucky. Plus anticipates that the MSA will lead to clinical and commercial supply agreements for the drug product at the appropriate stage of development.

    PPS's Lexington site is recognized as a North American leader in formulation development and manufacture of sterile parenteral drug products.

    "This agreement represents another significant milestone for Plus as we work to advance development of RNL as a novel treatment option for patients diagnosed with glioblastoma," said Marc Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. "The team at PPS has the knowledge, experience and expertise to support our needs, both now and in the future as we advance RNL towards regulatory approval."

    "We are thrilled to enter into this agreement with Plus Therapeutics," said Peter DeYoung, Chief Executive Officer of Piramal Pharma Solutions. "Our expectation is that this MSA represents the start of a long, mutually beneficial relationship that will address our ultimate collective objective of reducing the burden of disease on patients."

    About Plus Therapeutics, Inc.

    Plus Therapeutics (NASDAQ:PSTV) is a clinical-stage pharmaceutical company whose radiotherapeutic portfolio is concentrated on nanoliposome-encapsulated radionuclides for several cancer targets. Central to the Company's drug development is a unique nanotechnology platform designed to reformulate, deliver and commercialize multiple drugs targeting rare cancers and other diseases. The platform is designed to facilitate new delivery approaches and/or formulations of safe and effective, injectable drugs, potentially enhancing the safety, efficacy and convenience for patients and healthcare providers. More information may be found at PlusTherapeutics.com and ReSPECT-Trials.com.

    About Piramal Pharma Solutions

    Piramal Pharma Solutions (PPS) is a contract development and manufacturing organization offering end-to-end development and manufacturing solutions across the drug life cycle. They serve clients through a globally integrated network of facilities in North America, Europe and Asia. This enables them to offer a comprehensive range of services including drug discovery solutions, process and pharmaceutical development services, clinical trial supplies, commercial supply of APIs and finished dosage forms. We also offer specialized services like development and manufacture of highly potent active pharmaceuticals ingredients and antibody drug conjugation. PPS's capability as an integrated service provider and experience with various technologies enables them to serve innovator and generic companies worldwide.

    Cautionary Statement Regarding Forward-Looking Statements

    This press release contains certain statements that may be deemed "forward-looking statements" within the meaning of U.S. securities laws. All statements, other than statements of historical fact, that address activities, events or developments that we intend, expect, project, believe or anticipate and similar expressions or future conditional verbs such as will, should, would, could or may occur in the future are forward-looking statements. Such statements are based upon certain assumptions and assessments made by our management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. These statements include, without limitation, statements about: the Company's potential to facilitate new delivery approaches and/or formulations of safe and effective, injectable drugs, potentially enhancing the safety, efficacy and convenience for patients and healthcare providers; the Company's potential to develop drug candidates currently in its product pipeline; and the Company's potential to develop additional drugs outside of its current pipeline. The forward-looking statements included in this press release are subject to a number of additional material risks and uncertainties, including but not limited to: the risk that the Company is not able to successfully develop product candidates that can leverage the U.S. FDA's accelerated regulatory pathways; and the risks described under the heading "Risk Factors" in the Company's Securities and Exchange Commission filings, including in the Company's annual and quarterly reports. There may be events in the future that the Company is unable to predict, or over which it has no control, and its business, financial condition, results of operations and prospects may change in the future. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.

    Investor Contact

    Peter Vozzo

    Westwicke/ICR

    (443) 377-4767

    Media Contact

    Terri Clevenger

    Westwicke/ICR

    (203) 856-4326



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