Plus Therapeutics

Plus Therapeutics is dedicated to developing and delivering innovative cell-based therapies to improve the quality and length of life. It is a global, public company engaged in developing and commercializing stem and regenerative cell therapies for treating cardiovascular disease, reconstructive surgery, and other serious, chronic, and life-threatening conditions. The company's research and development efforts are developing novel formulations and delivery methods for existing drugs to improve their efficacy and reduce side effects. Plus Therapeutics utilizes its proprietary nanotechnology platform to enhance the therapeutic potential of drugs, allowing for targeted delivery to tumors while minimizing damage to healthy tissues. Their pipeline includes potential treatments for various types of cancer, including brain cancer and pancreatic cancer. Plus Therapeutics' pipeline of candidate drug products includes their lead drug product candidates, RNL and DocePLUS, which are being developed in the U.S. by a dedicated and energetic team of biologists, chemists, engineers, physicians, and other professionals.

<div>Plus Therapeutics (PSTV) was a US clinical-stage pharmaceutical company focused on developing innovative radiotherapeutics for the treatment of cancer. The company leveraged a hybrid virtual drug development model, enabling operational efficiencies, cost reduction, and accelerated product development. Plus Therapeutics had laboratories and state-of-the-art clean rooms in San Antonio, Texas, dedicated to preclinical and development work. The company's strategic location in Texas provided proximity to world-class cancer institutions, researchers, and access to funding opportunities through the Cancer Prevention and Research Institute of Texas (CPRIT).</div>

Plus Therapeutics (PSTV)

Radioactive materials open up new pathways in patient treatment and medication

Radiopharmaceuticals

<div>Plus Therapeutics is a clinical-stage pharmaceutical company specializing in the development and commercialization of innovative radiotherapeutics for cancer treatment. Originally founded as Cytori Therapeutics, the company rebranded to Plus Therapeutics in July 2019. Their proprietary radiotherapeutic platform leverages nanotechnology to create targeted therapies, notably rhenium (186Re) obisbemeda, aimed at treating central nervous system cancers such as glioblastoma and leptomeningeal metastases. The company&rsquo;s technology focuses on delivering precise doses of radiation directly to tumors, minimizing damage to surrounding healthy tissues.</div>

Leveraging personal data for custom-fit diagnosis and treatment

Precision Medicine

Leptomeningeal Metastases Pipeline Development Research Report 2024, Featuring AstraZeneca, Kazia Therapeutics, and Plus Therapeutics

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 Plus Therapeutics (PSTV) was a US clinical-stage pharmaceutical company focused on developing innovative radiotherapeutics for the treatment of cancer. The company leveraged a hybrid virtual drug development model, enabling operational efficiencies, cost reduction, and accelerated product development. Plus Therapeutics had laboratories and state-of-the-art clean rooms in San Antonio, Texas, dedicated to preclinical and development work. The company's strategic location in Texas provided proximity to world-class cancer institutions, researchers, and access to funding opportunities through the Cancer Prevention and Research Institute of Texas (CPRIT).
 
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Avid Radiopharmaceuticals, a subsidiary of Eli Lilly, developed the first radioactive diagnostic agent approved by the US Food and Drug Administration (FDA) for imaging tau neurofibrillary tangles on positron emission tomography (PET) scans. The F-18 flortaucipir tracer, marketed under the name Tauvid, helps clinicians estimate the density and distribution of tau tangles in the brains of adults with cognitive impairment being evaluated for Alzheimer's disease.
Tauvid works by binding to tau proteins that form neurofibrillary tangles, which are a hallmark of Alzheimer's disease along with amyloid plaques. Previously, doctors could only diagnose Alzheimer's neuropathologically by identifying both plaques and tangles in the brain after death. With Tauvid, physicians can now visualize and assess tau pathology in living patients through PET imaging.
The FDA's approval of Tauvid in May 2020 was supported by two clinical studies evaluating the agent's safety and effectiveness. These studies demonstrated that readers interpreting Tauvid PET scans had a high probability of accurately detecting tau pathology and an average-to-high probability of correctly identifying patients without tau pathology.

Avid Radiopharmaceuticals

Trevarx is a biomedical company focused on developing radiopharmaceutical technologies to combat breast, ovarian, and prostate cancer. The company specializes in small molecule radiopharmaceuticals, offering a unique theranostic solution. Trevarx's approach combines therapeutic and diagnostic capabilities, potentially enhancing cancer treatment efficacy. The company leverages its expertise in scientific research and multi-center trials to advance its radiopharmaceutical technologies. Trevarx's business model includes providing support for multi-center trials, regulatory assistance, and GMP (Good Manufacturing Practice) manufacturing. These services aim to accelerate the commercialization process of their radiopharmaceutical technologies. The company's team comprises experts with extensive experience in the field, positioning Trevarx to efficiently develop and bring its solutions to market.

Trevarx Biomedical

Alpha Source is a company that manufactures and supplies alpha radiation sources, primarily composite alpha sources containing Pu-239, Am-241, and Cm-244 radionuclides electroplated onto platinum or platinum-clad nickel foils. These sources are designed for alpha spectroscopy systems, providing alpha particles in the energy range of approximately 5100 to 5800 keV with line widths typically less than 20 keV FWHM. This wide energy range allows for valid energy calibration of most alpha-emitting nuclides. Alpha Source offers its composite alpha sources in three configurations: A-1, A-2, and PM. The sources are uncovered and have an active area of 5.0 mm. When purchased as NIST traceable standards, the sources can also be used to determine detector efficiencies for alpha particles, with total and individual activities provided on the Certificate of Calibration.
In addition to its core alpha source product line, Alpha Source also provides nationwide service for extending the life of ultrasound imaging equipment through preventative maintenance and quality replacement parts. The company offers high-quality replacement parts for biomedical equipment, along with value-added services to streamline supply chain operations.
Alpha Source has over 30 years of expertise in manufacturing and sourcing high-quality medical replacement battery packs, offering solutions that optimize battery life and costs for healthcare facilities.

Alpha Source

Ionetix is a cyclotron technology and isotope manufacturing company based in the US. It developed the world's first commercial compact superconducting cyclotron, the ION-12SC, which is used to produce N-13 Ammonia, a highly accurate Positron Emission Tomography (PET) imaging agent for detecting Coronary Artery Disease (CAD). The company's proprietary cyclotron technology platform enables access to scarce radioisotopes used for diagnostic and therapeutic radiopharmaceuticals.
Ionetix's cyclotrons can produce high-purity alpha-emitting radionuclides like Actinium-225 (Ac-225) and Astatine-211 (At-211), which are utilized in targeted alpha therapies for cancer treatment. In April 2023, the company successfully produced Astatine-211 at its new Alpha Isotope Manufacturing facility in Lansing, Michigan, using a 30 MeV cyclotron. This facility is dedicated exclusively to producing alpha-emitting radionuclides via cyclotrons. In June 2024, Ionetix announced the successful production of Actinium-225, marking a pivotal milestone as the first commercial cyclotron-produced Ac-225.
Ionetix's business model involves establishing a network of ION-12SC cyclotrons installed on or near the campuses of PET programs across the US. The company covers the costs related to installation and operation, making N-13 Ammonia available to providers through a pay-by-the-dose model, ensuring accessibility and affordability. Ionetix also provides N-13, F-18, and Ga-68 for diagnostic imaging. Its distribution supply chain includes contract drug manufacturing and "white glove" distribution logistics, enabling global access to these imaging agents and targeted radiotherapies.

Ionetix

Therapeia GmbH & Co. KG is a German specialist company focused on developing diagnostic and therapeutic radiopharmaceuticals to address unmet patient needs. Their lead product candidate, ACD-101, is a family of products for the diagnosis and treatment of malignant glioma (brain cancer). ACD-101 combines several anti-cancer effects within a single molecule, including cytostatic properties, an intrinsic radio-sensitizer effect that enhances the efficacy of external radiation therapy (the current standard treatment), and the ability to be radiolabeled with 131I for intracellular 131I-irradiation ("endo-radiotherapy"), similar to radioiodine therapy used for thyroid cancer.
ACD-101 is actively transported across the intact blood-brain barrier and accumulates in tumor tissue, where it is retained for up to a week. This intratumor accumulation occurs independently of histological tumor type in both low and high-grade gliomas (WHO grades II-IV), allowing for universal therapeutic use regardless of glioma histology. In a rat model, experimental human gliomas were curatively treated for the first time using 131I-ACD-101. This endo-radiotherapy can be combined with conventional external radiotherapy to maximize synergies of different anti-tumor modes of action.

Therapeia GmbH & Co. KG

Companies that use radioactive isotopes to develop medication for the treatment of diseases in patients.

Companies that use radioisotopes to develop solutions for the diagnosis of patients. Solutions are typically synthesized for internal use on patients and are employed in tandem with a diagnostic imaging device to identify disease or causes of diseases.

Companies that produce and supply radioisotopes to pharmaceutical companies creating radiopharmaceuticals.

Companies providing support services to radiopharmaceutical-related companies. These include testing services, research, and training.

Some drug developers use connected medical devices for monitoring treatment administration and drug development

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 Plus Therapeutics is a clinical-stage pharmaceutical company specializing in the development and commercialization of innovative radiotherapeutics for cancer treatment. Originally founded as Cytori Therapeutics, the company rebranded to Plus Therapeutics in July 2019. Their proprietary radiotherapeutic platform leverages nanotechnology to create targeted therapies, notably rhenium (186Re) obisbemeda, aimed at treating central nervous system cancers such as glioblastoma and leptomeningeal metastases. The company&rsquo;s technology focuses on delivering precise doses of radiation directly to tumors, minimizing damage to surrounding healthy tissues.
 
 
 
 
 Since 2004, Plus Therapeutics has operated as a publicly listed company and is traded on Nasdaq under the ticker symbol PSTV.
 
 
 
 
 Key customers and partnerships
 
 
 
 
 &nbsp;The company's primary customers are healthcare providers and research institutions involved in cancer treatment and diagnostics. Plus Therapeutics collaborates with various healthcare institutions and research organizations to advance its radiotherapeutic solutions.&nbsp;
 
 
 
 In 
 <a href="https://sp-edge.com/updates/21709">
 September 2023
 </a>
 , Plus Therapeutics partnered with Biocept to exclusively license Biocept's CNSide assay for patients receiving central nervous system (CNS) radiotherapy. Other notable partnerships include agreements with NanoTx Corp. and The University of Texas Health Science Center at San Antonio. These collaborations facilitate the development and clinical testing of its innovative therapies. 
 
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 Praxis Precision Medicines is a clinical-stage biopharmaceutical company that develops precision medicine for central nervous system disorders based on neuronal imbalance caused by genetic mutations.
 
 
 The company has four clinical-stage product candidates in its pipeline for treating disorders such as depression, epilepsy, movement disorders, and pain syndromes. The company&rsquo;s drug candidates include 1) PRAX-944, which is an inhibitor for essential tremor disorder linked to Parkinson&rsquo;s disease and is set to begin Phase 3 in mid-2023, 2) PRAX-222 in Phase 2 of clinical trials targets the SCN2A gene most commonly associated with early-onset epilepsy, 3) PRAX-562 was designed to block persistent sodium for patients suffering from rare diseases such as headache disorders and severe seizures and completed Phase 1 of clinical trials, and 4) PRAX-628 in Phase 2 clinical trials for treating focal epilepsy that originates in one side or area of the brain and affects one side of the body. Additionally, the firm has six pre-clinical drug candidates.
 
 
 Funding and financials
 
 
 The company went public in October 2020, trading on the Nasdaq Global Select Market under the ticker symbol &ldquo;PRAX&rdquo;. 
 <a href="https://sp-edge.com/updates/19453">
 In June 2023 
 </a>
 , the company announced an underwritten public offering of its common shares and pre-funded warrants, to raise approximately USD 59.1 million. The capital raised was used to support the company&rsquo;s ongoing operations and strategic initiatives, furthering the development of its pipeline and potential future endeavors.
 
 
 For the year 
 <a href="https://sp-edge.com/updates/16211">
 2022
 </a>
 , net losses increased by 28% YoY to USD 214 million arising from a significant increase in R&amp;D expense (up by 29% YoY). For the six months ended June 2023, the company is yet to generate revenue from drugs, however received collaboration revenue of USD 1.5 million. Further, it reported a decline in net loss by 43.0% YoY to USD 34.3 million. Its cash and cash equivalent as of June 2023 was at USD 124.3 million, compared to USD 61.6 million in December 2022, which the company believes will be adequate to fund operations till Q1 2025. 
 
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Praxis Precision Medicines

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 Mirati Therapeutics is a commercial-stage biotechnology company developing oncology-targeted therapies to address KRAS mutations present in 25% of tumors, including lung, colorectal and pancreatic cancers. Mirati&rsquo;s lead product KRAZATI (adagrasib/ MRTX849) is an oral&nbsp; KRASG12C inhibitor approved in 2022 for certain non-small cell lung cancers.The company also has sitravatinib, a multi-kinase inhibitor, in Phase 3 trials for non-small cell lung cancer in combination with a Bristol-Myers Squibb checkpoint inhibitor.
 
 
 
 
 Additionally, Mirati is advancing multiple early-stage programs including KRAS G12D inhibitor MRTX1133 for pancreatic and colorectal cancers, which entered Phase 1 in 2023, as well as a synthetic lethal inhibitor MRTX1719. In December 2022, the company submitted an IND application for MRTX1133, a potent and selective KRAS G12D inhibitor, which was cleared by the FDA in January 2023. 
 
 
 Key partnerships and customers
 
 
 
 
 Mirati has multiple partnerships with leading biopharma companies to advance its pipeline, including discovery collaborations with Pfizer and clinical collaborations with Novartis, Boehringer Ingelheim, and 
 <a href="https://sp-edge.com/updates/14345">
 Incyte
 </a>
 . The company also has licensing agreements with BeiGene for sitravatinib and Zai Lab for MRTX849 in certain Asian markets.
 
 
 
 
 
 Funding and Financials
 
 
 
 
 The company went public in June 2013 to trade on Nasdaq under the ticker symbol &ldquo;MRTX&rdquo;. In August 2023, the company closed an 
 <a href="https://sp-edge.com/updates/20988">
 underwritten public offering
 </a>
 at USD 345 million. The new funds were used towards drug development and leadership expansion.&nbsp;
 
 
 
 
 <a href="https://sp-edge.com/updates/16725">
 For the year 2022 
 </a>
 , the firm's net losses increased to USD 740.9 million from USD 581.8 million. Net product revenue for the full year amounted to USD 0.7 million arising from the sale of KRAZATI, which received FDA approval for its commercial launch in December 2022. 
 
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Mirati Therapeutics

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 Tvardi Therapeutics is a clinical-stage biotechnology company developing precision medicine for different cancers, chronic inflammatory diseases, and fibrotic diseases. The company&rsquo;s pipeline focuses on the development of small-molecule inhibitors of STAT3, a regulatory protein that allows cancer cells to evade the immune system and survive.
 
 
 The company&rsquo;s orally administered monotherapy and lead product, TTI-101, is in Phase 1 clinical trials for patients with advanced solid tumors who have failed all other lines of therapy. Additionally, the drug is in preclinical trials for treating fibrosis and inflammation. The company is also developing TTI-102, a next-generation STAT3 inhibitor that is structurally similar but chemically different from TTI-101.&nbsp;
 
 
 Founded in 2017, the Texas-based company closed a Series B funding round in June 2021, which brought total funding to USD 81 million and the proceeds will be used to advance Tvardi&rsquo;s drug candidates through its clinical data readouts in mid-stage trials for cancer and fibrosis.
 
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Tvardi Therapeutics

<div>
 
 Tango Therapeutics is a clinical-stage biotech company developing precision oncology therapies targeting synthetic lethality in cancer which leads to cell death. Its discovery platform identifies novel targets to develop drugs focused on: 1) countering tumor suppressor gene loss to help the immune system recognize and kill cancer cells, and 2) reversing cancer cell evasion of the immune system.
 
 
 
 
 Tango has five pipeline programs, including lead candidate TNG908, an inhibitor for multiple cancer indicators. The FDA approved TNG908's IND in January 2022 and granted it Orphan Drug Designation. TNG908 is in Phase I/II trials, with preliminary efficacy data expected in H1 2023. Tango also plans to file INDs for TNG260 (STK11 mutant cancers) and TNG348 (BRCA1/2-mutant cancers). In 
 <a href="https://www.globenewswire.com/news-release/2023/01/25/2595034/0/en/Tango-Therapeutics-Announces-FDA-Clearance-of-Investigational-New-Drug-Application-for-TNG462-Provides-Additional-Business-Updates.html">
 January 2023
 </a>
 , the FDA cleared the IND for TNG462, a next-gen PRMT5 inhibitor for cancers with MTAP deletion.
 
 
 
 
 Key partnerships and customers
 
 
 
 
 
 Outside its pipeline, the company also entered into a collaborative partnership with big pharma Gilead Sciences Inc., in October 2018 which was later expanded for two years in August 2020 to identify new immune evasion targets.
 
 
 
 
 Funding and financials&nbsp;
 
 
 
 
 
 Tango went public in August 2021 via a SPAC deal, trading on Nasdaq under the ticker symbol &ldquo;TNGX&rdquo;, and the company received gross proceeds of USD 353 million. In August 2023, the company raised USD 80 million via a 
 <a href="https://sp-edge.com/updates/20955">
 private placement
 </a>
 , which was led by Nextech. The new funds were used toward expanding its TNG908 and TNG462 PRMT5 programs to various other indications.
 
 
 
 
 Tango has not yet generated any drug sales and does not expect to do so for several years. However, for the full-year the company reported collaboration revenue of USD 24.9 million (down 4.42% YoY) and a net loss of USD 108.2 million (up 85.9% YoY).
 
 
 
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Tango Therapeutics

<div>
 
 IDEAYA Biosciences is a clinical-stage biotech developing precision cancer therapies based on synthetic lethality - when specific gene mutations pair to cause cell death. The company also studies combining synthetic lethality with immunotherapies and DNA damage to enhance treatment efficacy. While current drugs target limited mutations like BRCA1/2, IDEAYA aims to treat broader genetic subpopulations.&nbsp;
 
 
 
 
 Its pipeline includes synthetic lethality-driven precision medicines across four potential first-in-class clinical-stage product candidates. Of these, the company owns/controls commercial rights of the three most-advanced of these product candidates: darovasertib, IDE397, and IDE161. As of May 2024, the company was also advancing Werner Helicase program for which a development candidate has been selected in collaboration with GlaxoSmithKline, and, subject to investigational new drug-, or IND-, enabling studies, are targeting an IND in 2024. In addition. the company also works on multiple earlier-stage preclinical programs. 
 
 
 By targeting specific genetic drivers, IDEAYA advances precision oncology using synthetic lethality approaches. The company is focused on developing novel targeted therapies for patient populations with high unmet need and limited treatment options.&nbsp;&nbsp;
 
 
 In December 2023, IDEAYA Biosciences teamed up with Gilead Sciences to test the combination of IDE397 and Trodelvy in a Phase I clinical trial for MTAP-deletion bladder cancer.
 
 
 
 
 Key partnerships and customers
 
 
 
 
 The company collaborates with pharmaceutical partners to advance its pipeline, including a strategic partnership with GSK in June 2020. The collaboration with GSK covers co-development and commercialization of two synthetic lethality programs. IDEAYA received USD 100 million upfront and USD 20 million in a direct private placement through the GSK deal. In June 2022, IDEAYA announced it would co-develop its Pol Theta candidate with GSK, with a Phase 1 trial starting in the first half of 2023.&nbsp;
 
 
 
 
 IDEAYA also holds an exclusive license from Novartis for LXS196 (IDE196), a PKC inhibitor for metastatic uveal melanoma. Additionally, the company is exploring IDE196 combinations with Pfizer and its potential in other rare skin diseases. In July 2022, IDEAYA signed an agreement with Amgen to evaluate IDE397 with Amgen's AMG 193 in solid tumors. Strategic pharma partnerships help advance and expand IDEAYA's pipeline of synthetic lethality precision oncology programs.
 
 
 
 
 Funding and financials
 
 
 
 
 
 The company was listed on the Nasdaq Global Select Market under the ticker symbol &ldquo;IDYA&rdquo; in May 2019, raising USD 50 million via an initial public offering. In September 2022, the company raised USD 92 million.&nbsp;
 
 
 
 
 For 2022, the company reported a net loss of USD 58.7 million (up 17.9% YoY) while collaboration revenue was USD 50.9 million (up 82.3% YoY). 
 
 
 On October 24, 2023, IDEAYA Biosciences priced an underwritten public offering of 5 million shares of common stock and pre-funded warrants to purchase 319,150 shares of common stock. The common stock offered was priced at USD 23.50 per share, while the exercise price of a pre-funded warrant was USD 0.0001. The offering was expected to bring in approximately USD 125 million in gross proceeds.
 
 
 
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IDEAYA Biosciences

Companies providing genetic tests to identify individuals with high risk or at-risk of having hereditary disease, aid physicians with a diagnosis, and support clinical decision making.

Secure cloud-based platforms and data sharing networks that collect, index, store, and analyze large amounts of health data and patient population data sets from sources including genomic, clinical, wearables, imaging, and population data.

Biopharma and biotechnology companies that develop precision medicine drugs based on novel disease biomarkers present in multi-omic patient population data and genetic insights.

Companies that study intergenomic variations in genes associated with drug response and metabolism to match patients with the appropriate drug and dosage.

Companies that develop an in-vitro medical device or imaging tools and tests that identify genetic mutations for both diagnostic (nature of the disease) and prognostic (likely course of the disease) purposes, allowing providers to match a patient to a specific drug or therapy.

Software analytics platforms that integrate multiple omics datasets (genomics, transcriptomics, proteomics, and metabolomics) to gain insights and support target discovery, drug development, clinical trials, and diagnostics.

Some companies leverage AI/ML to develop tailored medication

Considers individual variability in genes, environment, and lifestyle for each person

Genomics is used across all the segments of precision medicine from diagnostic solutions to treatments

AI/ML analyzes genomic data to find drug targets, predict disease progression, and treatment response

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 Plus Therapeutics has been recommended for a grant of USD 3 million by the Department of Defense's Congressionally Directed Medical Research Programs office. The grant is expected to be disbursed from the third quarter of 2024.
 The grant proceeds will be utilized to expand the clinical trial for the treatment of pediatric brain cancer led by the company. The beginning of this initiative is expected to be in the second half of 2024, post-contract finalization. This funding is also projected to aid the development of Rhenium (186Re) obisbemeda, a new injectable radiotherapy for brain tumors, commencing in the second half of 2025.
 Plus Therapeutics works on the development of targeted radiotherapeutics for the treatment of challenging central nervous system cancers. Its techniques encompass unique image-guided local beta radiation and targeted drug delivery strategies.

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Plus Therapeutics

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