Lithium Royalty Corp. Announces Final Results of Substantial Issuer Bid
TORONTO, May 16, 2025--(BUSINESS WIRE)--Lithium Royalty Corp (TSX: LIRC) ("LRC" or the "Company) announces the final results of its substantial issuer bid (the "Offer"), pursuant to which the Company offered to purchase up to C$7 million in value of its outstanding common shares (the "Shares") from holders of Shares (the "Shareholders") for cash, at a single price per Share of not less than C$5.20 per Share and not more than C$5.70 per Share, through a "modified Dutch auction" process.
In accordance with the terms and conditions of the Offer and based on the calculations of TSX Trust Company, as depositary for the Offer (the "Depositary"), the purchase price determined by the modified Dutch auction process will be C$5.70 per Share (the "Purchase Price"), and the Company will take up and pay for all 561,594 Shares tendered to the Offer at the Purchase Price.
The Company commenced the Offer in part on the basis that the repurchase of Shares was an attractive investment by the Company and because the trading price of the Shares was meaningfully below estimates of net asset value per Share. Notwithstanding the extension to the original tender period and the increase in the original tender price range both announced on April 30, 2025, holders of Shares largely determined to continue holding their Shares, such that the Shares tendered to the Offer represented only 45.7% of the C$7 million maximum purchase amount of the Offer. The Company will continue to explore opportunities to grow net asset value per share, including through additional share repurchases if determined appropriate. Following the expiry of the Offer, the Company will no longer be restricted from making purchases under its normal course issuer bid.
Payment for the Shares accepted for purchase under the Offer will occur in accordance with the terms of the Offer and applicable law. The Shares tendered to the Offer represent approximately 2.24% of the total number of the Company's issued and outstanding Shares as of May 15, 2025, before giving effect to the results of the Offer. After the cancellation of the Shares taken up and paid for by the Company, LRC anticipates that approximately 24,494,283 Shares will be issued and outstanding, together with 30,549,214 convertible common shares of the Company (together with the Shares, "Equity Shares") issued and outstanding, for an aggregate of 55,043,497 Equity Shares.
To assist shareholders in determining the Canadian tax consequences of the Offer, the Company estimates that for the purposes of the Income Tax Act (Canada), the paid-up capital per Share is approximately C$6.51 and the "specified amount" for purposes of subsection 191(4) of the Income Tax Act (Canada) is approximately C$5.65.
Details of the Offer are available in the formal offer to purchase and issuer bid circular dated March 25, 2025, as amended by the notice of variation dated April 30, 2025 (the "Notice of Variation"), the amended letter of transmittal and the amended notice of guaranteed delivery (collectively, the "Offer Documents"). The Notice of Variation extended the original expiry date and increased the tender price range of the Offer.
This news release is for informational purposes only and does not constitute an offer to buy or the solicitation of an offer to sell Shares.
About Lithium Royalty Corp.
LRC is a lithium-focused royalty company organized in Canada, which has established a globally diversified portfolio of 35 revenue royalties on mineral properties that are related to the electrification and decarbonization of the global economy. The Company's royalty portfolio is focused on the battery supply chain for the transportation and energy storage industries and is underpinned by mineral properties that produce or are expected to produce lithium and other battery materials. LRC is a signatory to the Principles for Responsible Investment; the integration of ESG factors and sustainable mining are considerations in our investment analysis and royalty acquisitions.
Forward Looking Statements
This press release contains "forward-looking information" and "forward-looking statements" within the meaning of applicable Canadian securities laws, which may include, but are not limited to, statements with respect to future events or future performance, the Company's current intentions regarding the Offer, the timing, terms and conditions of the Offer, estimates of the net asset value per Share, the source of funds through which the Shares will be purchased, the ultimate Purchase Price, the number of Shares to be purchased and the resumption of the NCIB. Often, but not always, forward-looking statements can be identified by the use of words such as "plans", "expects", "is expected", "budgets", "potential for", "scheduled", "estimates", "forecasts", "predicts", "projects", "intends", "targets", "aims", "anticipates" or "believes" or variations (including negative variations) of such words and phrases or may be identified by statements to the effect that certain actions "may", "could", "should", "would", "might" or "will" be taken, occur or be achieved. Forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause the actual results, performance or achievements of LRC to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Forward-looking information is based on management's beliefs and assumptions and on information currently available to management. The forward-looking statements herein are made as of the date of this press release only and LRC does not assume any obligation to update or revise them to reflect new information, estimates or opinions, future events or results or otherwise, except as required by applicable law.
A number of factors could cause actual events or results to differ materially from any forward-looking statement, including, without limitation: fluctuations in the prices of the primary commodities that drive royalty revenue (including various lithium products); fluctuations in the value of the Canadian and Australian dollar and any other currency in which revenue is generated, relative to the U.S. dollar; changes in national and local government legislation, including permitting and licensing regimes and taxation policies and the enforcement thereof; the adoption of a global minimum tax on corporations; regulatory, political or economic developments in any of the countries where properties in which LRC holds a royalty or other interest are located or through which they are held; risks related to the operators of the properties in which LRC holds a royalty or other interest, including changes in the ownership and control of such operators; relinquishment or sale of mineral properties; influence of macroeconomic developments; business opportunities that become available to, or are pursued by LRC; reduced access to debt and equity capital; litigation; title, permit or license disputes related to interests on any of the properties in which LRC holds a royalty or other interest; whether or not the Company is determined to have "passive foreign investment company" ("PFIC") status as defined in Section 1297 of the United States Internal Revenue Code of 1986, as amended; excessive cost escalation as well as development, permitting, infrastructure, operating or technical difficulties on any of the properties in which LRC holds a royalty or other interest; actual mineral content may differ from the resources and reserves contained in technical reports; rate and timing of production differences from resource estimates, other technical reports and mine plans; risks associated with the solvency of operators of projects that LRC has royalties over; risks and hazards associated with the business of development and mining on any of the properties in which LRC holds a royalty or other interest, including, but not limited to unusual or unexpected geological and metallurgical conditions, slope failures or cave-ins, sinkholes, flooding and other natural disasters, terrorism, civil unrest or an outbreak of contagious disease; and the integration of acquired assets. The forward-looking statements contained in this press release are based upon assumptions management believes to be reasonable, including, without limitation: the ongoing operation of the properties in which LRC holds a royalty or other interest by the owners or operators of such properties in a manner consistent with past practice; the accuracy of public statements and disclosures made by the owners or operators of such underlying properties; no material adverse change in the market price of the commodities (including various lithium products) that underlie the asset portfolio; the Company's ongoing income and assets relating to determination of its PFIC status; no material changes to existing tax treatment; the expected application of tax laws and regulations by taxation authorities; no adverse development in respect of any significant property in which LRC holds a royalty or other interest; the solvency of project operators; the accuracy of publicly disclosed expectations for the development of underlying properties that are not yet in production; integration of acquired assets; and the absence of any other factors that could cause actions, events or results to differ from those anticipated, estimated or intended. However, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Investors are cautioned that forward-looking statements are not guarantees of future performance. LRC cannot assure investors that actual results will be consistent with these forward-looking statements. Accordingly, investors should not place undue reliance on forward-looking statements due to the inherent uncertainty therein.
For additional information with respect to risks, uncertainties and assumptions, please refer to LRC's most recent Annual Information Form dated March 17, 2025 and filed with the Canadian securities regulatory authorities on www.sedarplus.com. These risks and uncertainties include, but are not limited to, those described under "Risk Factors" in the Annual Information Form, and in particular risks summarized under the "Risks Related to Mining Operations" heading.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250515449094/en/
Contacts
Contact Information for Inquiries:
Jonida ZaganjoriInvestor Relations(647) 792-1100jonida@lithiumroyaltycorp.com
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TOKYO & BASKING RIDGE, N.J.--(BUSINESS WIRE)--Results from three trials continue to demonstrate the potential of DATROWAY ® (datopotamab deruxtecan) in combination with various immunotherapies to improve outcomes in patients with non-small cell lung cancer (NSCLC) across multiple stages of the disease. These results from TROPION-Lung02, TROPION-Lung04 and NeoCOAST-2 were presented at the 2025 American Society of Clinical Oncology (#ASCO25) Annual Meeting. DATROWAY is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/Nasdaq: AZN). 'Patients with non-small cell lung cancer have limited treatment options and often experience disease progression due to the aggressive nature of the disease,' said Benjamin Levy, MD, Clinical Director, Medical Oncology, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Medicine. 'The safety and efficacy data from these trials and the exploratory QCS analysis from TROPION-Lung02 support the potential of DATROWAY to become an important medicine to use in combination with various immunotherapies to improve outcomes for patients across multiple stages of lung cancer.' 'These data presented at ASCO continue to reinforce the potential for DATROWAY to become an important part of immunotherapy-based combination regimens for the treatment of certain patients with non-small cell lung cancer,' said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. 'We look forward to further evaluation of these combinations through our robust clinical development program in order to determine how DATROWAY may help address unmet needs of patients with lung cancer.' 'The DATROWAY combination data at ASCO, including results with our own durvalumab and rilvegostomig as well as pembrolizumab, support the combinability of this medicine and its potential to change treatment expectations across stages of lung cancer,' said Cristian Massacesi, MD, Chief Medical Officer and Oncology Chief Development Officer, AstraZeneca. 'Further, the results from the TROPION-Lung02 exploratory biomarker analysis offer additional evidence that the more precise measurement of TROP2, as enabled by our computational pathology platform, can help identify patients with non-small cell lung cancer more likely to respond to DATROWAY.' DATROWAY plus pembrolizumab with or without platinum-based chemotherapy show consistent tumor responses as first-line treatment of advanced NSCLC Final results from the TROPION-Lung02 phase 1b trial of DATROWAY plus Merck's (known as MSD outside of the United States and Canada) anti-PD-1 therapy KEYTRUDA ® (pembrolizumab) with or without platinum chemotherapy in patients with advanced NSCLC without actionable genomic alterations were featured during an oral presentation (#8501) on Sunday, June 1. In 42 patients receiving first-line doublet DATROWAY plus pembrolizumab, an objective response rate (ORR) of 54.8% (95% confidence interval [CI]: 38.7-70.2) was observed. In 54 patients receiving first-line triplet DATROWAY plus pembrolizumab and platinum chemotherapy, an ORR of 55.6% (95% CI: 41.4-69.1) was observed. This analysis included patients enrolled during the dose escalation phase of the trial, where 4.8% and 40.7% of patients treated with the doublet and triplet regimens, respectively, received DATROWAY at a dose of 4 mg/kg versus 6 mg/kg. Median treatment duration was 9.7 months for patients receiving the doublet regimen and 5.8 months for those receiving the triplet regimen. The safety profiles of the doublet and triplet regimens of DATROWAY in TROPION-Lung02 were consistent with previous analyses. Grade 3 or higher treatment-related adverse events (TRAEs) occurred in 40.5% and 55.6% of patients receiving the doublet and triplet regimens, respectively. The most common grade 3 or higher TRAEs occurring in 5% or more of patients treated with the doublet regimen were increased amylase (14%) and stomatitis (5%). The most common grade 3 or higher TRAEs occurring in 5% or more of patients treated with the triplet regimen were decreased neutrophil count (15%), neutropenia (13%), anemia (13%), increased amylase (9%), fatigue (6%) and nausea (6%). Two (4.8%) grade 3 interstitial lung disease (ILD) events in patients treated with the doublet regimen and one (1.9%) grade 3 ILD event in patients treated with the triplet regimen were adjudicated as drug-related by an independent committee. In TROPION-Lung02, patients across six cohorts received DATROWAY plus pembrolizumab (doublet) or DATROWAY plus pembrolizumab and chemotherapy (triplet). As of data cut-off of April 29, 2024, 96 patients received either the doublet (n=42) or triplet (n=54) combination as first-line therapy. Summary of TROPION-Lung02 First-Line Efficacy Results Efficacy Measure Doublet Triplet Overall (n=42) PD-L1<50% (n=30) PD-L1≥50% (n=5) Overall (n=54) PD-L1<50% (n=40) PD-L1≥50% (n=10) Confirmed ORR, i,ii % (95% CI) 54.8% (38.7–70.2) 53.3% (34.3–71.7) 100% (47.8–100) 55.6% (41.4–69.1) 55% (38.5-70.7) 60% (26.2–87.8) CR, % 2.4% 3.3% 0% 3.7% 2.5% 10% PR, % 52.4% 50% 100% 51.9% 52.5% 50% SD, % 33% NA NA 33% NA NA PD, % 7% NA NA 4% NA NA DCR, % (n) iii (95% CI) 88.1% (37) (74.4–96.0) 96.7% (29) (82.8–99.9) 100% (5) (47.8–100) 88.9% (48) (77.4–95.8) 87.5% (35) (73.2–95.8) 90% (9) (55.5–99.7) Median DoR, (months) (95% CI) 20.1 months (9.7–NE) 12 months (8.0–NE) NE (5.5–NE) 13.7 months (5.7–NE) 14.6 months (5.3–NE) NE (4.1–NE) Median PFS, (months) (95% CI) 11.2 months (8.2–21.3) 11.1 months (7.2–13.3) NE (8.3–NE) 6.8 months (5.5–11.1) 6.4 months (5.5–13.2) 6.8 months (0.8–NE) CI, confidence interval; CR, complete response; DCR, disease control rate; DoR, duration of response; NA, not available; NE, not estimable; ORR, objective response rate; PD, progressive disease; PFS, progression-free survival; PR, partial response; SD, stable disease i ORR is CR+ PR ii As assessed by investigator iii Proportion of patients with confirmed CR + confirmed PR + SD. Expand Tissue samples collected from patients in TROPION-Lung02 were analyzed retrospectively using quantitative continuous scoring (QCS), AstraZeneca's proprietary computational platform. Tumors were considered biomarker positive if ≥75% of tumor cells exhibited a normalized membrane ratio (NMR) below a predetermined value (≤0.56), indicating a greater proportion of TROP2 in the cytoplasm than on the membrane. Results from this exploratory analysis showed that TROP2-NMR biomarker positivity was associated with a trend toward prolonged progression free survival (PFS) in patients treated with the doublet (hazard ratio [HR]: 0.50; 95% CI: 0.19-1.29) and triplet (HR: 0.67; 95% CI: 0.33-1.36) regimens, and a trend toward prolonged overall survival in patients treated with the doublet (HR: 0.35; 95% CI: 0.07-1.72) and triplet (HR: 0.71; 95% CI: 0.31-1.59) regimens compared to the TROP2-NMR biomarker negative population. DATROWAY plus rilvegostomig show encouraging activity in first-line treatment of advanced NSCLC First results from cohort 5 of the TROPION-Lung04 phase 1b trial, presented during a poster session (#8521) on Saturday, May 31, showed DATROWAY plus AstraZeneca's PD-1/TIGIT bispecific antibody rilvegostomig as a first-line treatment demonstrated an ORR of 57.5% (95% CI: 40.9-73.0), including one complete response (CR) and 22 partial responses (PRs) in 40 patients with advanced or metastatic NSCLC. A disease control rate (DCR) of 95% (95% CI: 83.1-99.4) was seen. Objective responses were observed across both squamous (45.5%; 95% CI: 16.7-76.6) and nonsquamous (62.1%; 95% CI: 42.3-79.3) histologies and all PD-L1 expression levels. Median duration of response (DoR) was 5.8 months (4.5-not evaluable [NE]). The safety profile of DATROWAY and rilvegostomig was consistent with the known safety profile of each agent with no new safety signals identified. Grade 3 or higher treatment-emergent adverse events (TEAEs) occurred in 60% of patients. The most common grade 3 or greater TEAEs were pneumonia (10%), pneumonitis (7.5%), anemia (2.5%), decreased appetite (2.5%), increased amylase (2.5%), musculoskeletal pain (2.5%), rash (2.5%) and stomatitis (2.5%). Three (7.5%) grade 2 ILD events and two (5%) grade 3 ILD events were adjudicated as drug-related by an independent committee. Cohort 5 of TROPION-Lung04 enrolled patients with untreated advanced NSCLC without actionable genomic alterations. As of data cut-off of October 24, 2024, 40 patients received DATROWAY plus rilvegostomig with a median treatment duration of 5.1 months. DATROWAY treatment was ongoing in 19 patients and rilvegostomig treatment was ongoing in 20 patients. Daiichi Sankyo and AstraZeneca are evaluating DATROWAY plus rilvegostomig as first-line treatment for patients with advanced or metastatic nonsquamous NSCLC with PD-L1 ≥50% and without actionable genomic alterations in the TROPION-Lung10 phase 3 trial. DATROWAY plus durvalumab and chemotherapy demonstrate encouraging pathological response rates in patients with early-stage resectable NSCLC Final results from Arm 4 of the NeoCOAST-2 phase 2 platform trial evaluating neoadjuvant DATROWAY plus AstraZeneca's anti-PD-L1 therapy IMFINZI ® (durvalumab) and single-agent platinum chemotherapy were presented during a poster session (#8046) on Saturday, May 31 and showed the combination demonstrated a pathologic complete response (pCR) rate of 35.2% (95% CI: 22.7-49.4) and a major pathologic response (mPR) rate of 63% (95% CI: 48.7-75.7). This was numerically higher than response rates shown by other combination regimens evaluated in Arm 1 and Arm 2 of NeoCOAST-2; however, the trial was not powered to make direct statistical comparisons between arms. These results, along with results from these other two arms of NeoCOAST-2, were simultaneously published in Nature Medicine. The safety profile of DATROWAY, durvalumab and single-agent platinum chemotherapy was consistent with the known safety profile of each agent with no new safety signals identified. Feasibility of surgery was maintained with this arm of NeoCOAST-2 relative to the standard of care. Grade 3 or higher TEAEs occurred in 24.1% of patients in the neoadjuvant period. About TROPION-Lung02 TROPION-Lung02 is an ongoing global, open-label, six-cohort phase 1b trial evaluating the safety and efficacy of DATROWAY at two dose levels (4 mg/kg and 6 mg/kg) in combination with Merck's anti-PD-1 therapy KEYTRUDA ® (pembrolizumab; 200 mg) with or without four cycles of platinum chemotherapy (carboplatin or cisplatin) in patients with previously untreated or pretreated locally advanced or metastatic NSCLC without actionable genomic alterations (e.g., EGFR, ALK, ROS1, NTRK, BRAF, RET, MET or other known AGAs). Participants with tumors that harbor KRAS mutations are eligible for this study. The primary endpoints of TROPION-Lung02 are dose-limiting toxicities and treatment-emergent adverse events. Secondary endpoints include ORR, DoR, PFS as assessed by investigator, overall survival, pharmacokinetics and anti-drug antibodies for DATROWAY and pembrolizumab. TROPION-Lung02 is one of three clinical trials along with the phase 3 TROPION-Lung07 and TROPION-Lung08 trials in a collaboration and supply agreement between Daiichi Sankyo, AstraZeneca and Merck (known as MSD outside of the United States and Canada) to evaluate the combination of DATROWAY and pembrolizumab. TROPION-Lung02 enrolled 145 patients in Asia, Europe and North America. For more information visit KEYTRUDA ® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. About TROPION-Lung04 TROPION-Lung04 is an ongoing global, open-label, 15-cohort phase 1b trial evaluating the safety and efficacy of DATROWAY (4 mg/kg or 6 mg/kg) in combination with immunotherapy (durvalumab, rilvegostomig or volrustomig) with or without up to four cycles of carboplatin in patients with advanced or metastatic NSCLC without actionable genomic alterations. Participants with tumors that harbor KRAS mutations are eligible for this study. Patients enrolled in the cohorts evaluating durvalumab were previously untreated or had received one or fewer lines of systemic chemotherapy without concomitant immunotherapy. The primary endpoints of TROPION-Lung04 are safety and tolerability. Secondary endpoints include ORR, DCR, duration of response and progression-free survival as assessed by investigator. Rilvegostomig is AstraZeneca's PD-1/TIGIT bispecific antibody. The TIGIT component of rilvegostomig is derived from the clinical-stage anti-TIGIT antibody, COM902, developed by Compugen Ltd. (Nasdaq/TASE: CGEN). TROPION-Lung04 will enroll more than 370 patients in Asia, Europe and North America. For more information visit About NeoCOAST-2 NeoCOAST-2 is a global, randomized, multicenter, open-label, multi-arm phase 2 platform trial conducted by AstraZeneca evaluating the efficacy and safety of durvalumab in multiple novel combinations, before and after surgery, in patients with resectable, early-stage (stage IIA-IIIB) NSCLC. The dual primary endpoints of NeoCOAST-2 are antitumor activity of neoadjuvant treatment assessed by pCR and the safety and tolerability of neoadjuvant and adjuvant treatment. Secondary endpoints include event-free survival, disease-free survival and ORR as determined by investigator using RECIST version 1.1, OS, feasibility of surgery, and mPR determined by central blinded independent pathologist review. NeoCOAST-2 will enroll approximately 630 patients in Asia, Europe and North America. For more information visit About Non-Small Cell Lung Cancer Nearly 2.5 million lung cancer cases were diagnosed globally in 2022. 1 NSCLC is the most common type of lung cancer, accounting for about 87% of cases. 2 While most NSCLC cases are diagnosed in the advanced setting, between 25 to 30% of diagnoses occur in the early stage of the disease. 3,4 Despite improvements in treatment for early-stage NSCLC, patients may experience disease recurrence even after complete tumor resection with or without treatment with adjuvant therapy. 5,6,7 For patients with advanced NSCLC without actionable genomic alterations, immunotherapy with or without platinum-based chemotherapy is the standard first-line treatment. While these medicines have improved outcomes in the first-line metastatic setting, most patients experience disease progression. 8,9,10 TROP2 is a protein broadly expressed in the majority of NSCLC tumors. 11 There is currently no TROP2 directed ADC approved in the U.S. for the treatment of lung cancer. 12,13 About DATROWAY DATROWAY (datopotamab deruxtecan; datopotamab deruxtecan-dlnk in the U.S. only) is a TROP2 directed ADC. Designed using Daiichi Sankyo's proprietary DXd ADC Technology, DATROWAY is one of six DXd ADCs in the oncology pipeline of Daiichi Sankyo, and one of the most advanced programs in AstraZeneca's ADC scientific platform. DATROWAY is comprised of a humanized anti-TROP2 IgG1 monoclonal antibody, developed in collaboration with Sapporo Medical University, attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. DATROWAY is approved in more than 30 countries for the treatment of adult patients with unresectable or metastatic HR positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease based on the results from the TROPION-Breast01 trial. About the DATROWAY Clinical Development Program A comprehensive global clinical development program is underway with more than 20 trials evaluating the efficacy and safety of DATROWAY across multiple cancers, including NSCLC, triple negative breast cancer and HR positive, HER2 negative breast cancer. The program includes eight phase 3 trials in lung cancer and five phase 3 trials in breast cancer evaluating DATROWAY as a monotherapy and in combination with other anticancer treatments in various settings. About the Daiichi Sankyo and AstraZeneca Collaboration Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize ENHERTU ® in March 2019 and DATROWAY in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of ENHERTU and DATROWAY. About the ADC Portfolio of Daiichi Sankyo The Daiichi Sankyo ADC portfolio consists of seven ADCs in clinical development crafted from two distinct ADC technology platforms discovered in-house by Daiichi Sankyo. The ADC platform furthest in clinical development is Daiichi Sankyo's DXd ADC Technology where each ADC consists of a monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The DXd ADC portfolio currently consists of ENHERTU, a HER2 directed ADC, and DATROWAY, a TROP2 directed ADC, which are being jointly developed and commercialized globally with AstraZeneca. Patritumab deruxtecan (HER3-DXd), a HER3 directed ADC, ifinatamab deruxtecan (I-DXd), a B7-H3 directed ADC, and raludotatug deruxtecan (R-DXd), a CDH6 directed ADC, are being jointly developed and commercialized globally with Merck & Co., Inc, Rahway, NJ, USA. DS-3939, a TA-MUC1 directed ADC, is being developed by Daiichi Sankyo. The second Daiichi Sankyo ADC platform consists of a monoclonal antibody attached to a modified pyrrolobenzodiazepine (PBD) payload. DS-9606, a CLDN6 directed PBD ADC, is the first of several planned ADCs in clinical development utilizing this platform. Ifinatamab deruxtecan, patritumab deruxtecan, raludotatug deruxtecan, DS-3939 and DS-9606 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established. DATROWAY U.S. Important Safety Information Indication DATROWAY ® is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable or metastatic, hormone receptor (HR)-positive, HER2-negative (IHC 0, IHC 1+, or IHC 2+/ISH−) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease. Contraindications None. Warnings and Precautions Interstitial Lung Disease/Pneumonitis DATROWAY can cause severe, life-threatening, or fatal interstitial lung disease (ILD) or pneumonitis. In TROPION-Breast01, ILD/pneumonitis occurred in 4.2% of patients treated with DATROWAY, including 0.5% of patients with Grade 3-4 ILD/pneumonitis, and 0.3% with fatal ILD/pneumonitis. Six patients (1.7%) permanently discontinued DATROWAY due to ILD/pneumonitis. The median time to onset of ILD/pneumonitis was 3.5 months (range: 1.2 months to 10.8 months). Patients were excluded from TROPION-Breast01 for a history of ILD/pneumonitis requiring treatment with steroids or for ongoing ILD/pneumonitis. Monitor patients for new or worsening respiratory symptoms indicative of ILD/pneumonitis (eg, dyspnea, cough, fever) during treatment with DATROWAY. For asymptomatic (Grade 1) ILD/pneumonitis, consider corticosteroid treatment (eg, ≥0.5 mg/kg/day prednisolone or equivalent). For symptomatic ILD/pneumonitis (Grade 2 or greater), promptly initiate systemic corticosteroid treatment (eg, ≥1 mg/kg/day prednisolone or equivalent) and continue for at least 14 days followed by gradual taper for at least 4 weeks. Withhold DATROWAY in patients with suspected ILD/pneumonitis and permanently discontinue DATROWAY if Grade ≥2 ILD/pneumonitis is confirmed. Ocular Adverse Reactions DATROWAY can cause ocular adverse reactions including dry eye, keratitis, blepharitis, meibomian gland dysfunction, increased lacrimation, conjunctivitis, and blurred vision. In TROPION-Breast01, ocular adverse reactions occurred in 51% of patients treated with DATROWAY. Seven patients (1.9%) experienced Grade 3 ocular adverse reactions, including dry eye, keratitis, and blurred vision. The most common (≥5%) ocular adverse reactions were dry eye (27%), keratitis (24%), blepharitis and increased lacrimation (8% each), and meibomian gland dysfunction (7%). Patients with clinically significant corneal disease were excluded from TROPION-Breast01. The median time to onset for ocular adverse reactions was 2.1 months (range: 0.03 months to 23.2 months). Of the patients who experienced ocular adverse reactions, 45% had complete resolution; 9% had partial improvement (defined as a decrease in severity by one or more grades from the worst grade at last follow up). Ocular adverse reactions led to permanent discontinuation of DATROWAY in 0.8% of patients. Advise patients to use preservative-free lubricant eye drops several times daily for prophylaxis. Advise patients to avoid use of contact lenses unless directed by an eye care professional. Refer patients to an eye care professional for an ophthalmic exam including visual acuity testing, slit lamp examination (with fluorescein staining), intraocular pressure, and fundoscopy at treatment initiation, annually while on treatment, at end of treatment, and as clinically indicated. Promptly refer patients to an eye care professional for any new or worsening ocular adverse reactions. Monitor patients for ocular adverse reactions during treatment with DATROWAY, and if diagnosis is confirmed, dose delay, dose reduce, or permanently discontinue DATROWAY based on severity. Stomatitis DATROWAY can cause stomatitis, including mouth ulcers and oral mucositis. In the TROPION-Breast01 study, stomatitis occurred in 59% of patients treated with DATROWAY, including 7% of patients with Grade 3-4 events. Median time to first onset was 0.7 months (range: 0.03 months to 8.8 months). Stomatitis led to interruption of DATROWAY in 1.9%, dosage reductions in 13%, and permanent discontinuation in 0.3% of patients. In patients who received DATROWAY, 38% used a mouthwash containing corticosteroid for management or prophylaxis of stomatitis/oral mucositis at any time during the treatment. Advise patients to use a steroid-containing mouthwash for prophylaxis and treatment of stomatitis. Instruct the patient to hold ice chips or ice water in the mouth throughout the infusion of DATROWAY. Monitor patients for signs and symptoms of stomatitis. If stomatitis occurs, increase the frequency of mouthwash and administer other topical treatments as clinically indicated. Based on the severity of the adverse reaction, withhold, dose reduce, or permanently discontinue DATROWAY. Embryo-Fetal Toxicity Based on its mechanism of action, DATROWAY can cause embryo-fetal harm when administered to a pregnant woman because the topoisomerase inhibitor component of DATROWAY, DXd, is genotoxic and affects actively dividing cells. Advise patients of the potential risk to a fetus. Advise female patients of reproductive potential to use effective contraception during treatment with DATROWAY and for 7 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with DATROWAY and for 4 months after the last dose. Adverse Reactions The safety of DATROWAY was evaluated in 360 patients with unresectable or metastatic HR-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH−) breast cancer who received at least one dose of DATROWAY 6 mg/kg in TROPION-Breast01. DATROWAY was administered by intravenous infusion once every three weeks. The median duration of treatment was 6.7 months (range: 0.7 months to 16.1 months) for patients who received DATROWAY. Serious adverse reactions occurred in 15% of patients who received DATROWAY. Serious adverse reactions in >0.5% of patients who received DATROWAY were urinary tract infection (1.9%), COVID-19 infection (1.7%), ILD/pneumonitis (1.1%), acute kidney injury, pulmonary embolism, vomiting, diarrhea, hemiparesis, and anemia (0.6% each). Fatal adverse reactions occurred in 0.3% of patients who received DATROWAY and were due to ILD/pneumonitis. Permanent discontinuation of DATROWAY due to an adverse reaction occurred in 3.1% of patients. Adverse reactions which resulted in permanent discontinuation of DATROWAY in >0.5% of patients included ILD/pneumonitis (1.7%) and fatigue (0.6%). Dosage interruptions of DATROWAY due to an adverse reaction occurred in 22% of patients. Adverse reactions which required dosage interruption in >1% of patients included COVID-19 (3.3%), infusion-related reaction (1.4%), ILD/pneumonitis (1.9%), stomatitis (1.9%), fatigue (1.7%), keratitis (1.4%), acute kidney injury (1.1%), and pneumonia (1.1%). Dose reductions of DATROWAY due to an adverse reaction occurred in 23% of patients. Adverse reactions which required dose reduction in >1% of patients included stomatitis (13%), fatigue (3.1%), nausea (2.5%), and weight decrease (1.9%). The most common (≥20%) adverse reactions, including laboratory abnormalities, were stomatitis (59%), nausea (56%), fatigue (44%), decreased leukocytes (41%), decreased calcium (39%), alopecia (38%), decreased lymphocytes (36%), decreased hemoglobin (35%), constipation (34%), decreased neutrophils (30%), dry eye (27%), vomiting (24%), increased ALT (24%), keratitis (24%), increased AST (23%), and increased alkaline phosphatase (23%). Clinically relevant adverse reactions occurring in <10% of patients who received DATROWAY included infusion-related reactions (including bronchospasm), ILD/pneumonitis, headache, pruritus, dry skin, dry mouth, conjunctivitis, blepharitis, meibomian gland dysfunction, blurred vision, increased lacrimation, photophobia, visual impairment, skin hyperpigmentation, and madarosis. Use in Specific Populations Pregnancy: Based on its mechanism of action, DATROWAY can cause embryo-fetal harm when administered to a pregnant woman because the topoisomerase inhibitor component of DATROWAY, DXd, is genotoxic and affects actively dividing cells. There are no available data on the use of DATROWAY in pregnant women to inform a drug-associated risk. Advise patients of the potential risks to a fetus. Lactation: There are no data regarding the presence of datopotamab deruxtecan-dlnk or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with DATROWAY and for 1 month after the last dose. Females and Males of Reproductive Potential: Pregnancy Testing: Verify pregnancy status of females of reproductive potential prior to initiation of DATROWAY. Contraception: Females: Advise females of reproductive potential to use effective contraception during treatment with DATROWAY and for 7 months after the last dose. Males: Because of the potential for genotoxicity, advise male patients with female partners of reproductive potential to use effective contraception during treatment with DATROWAY and for 4 months after the last dose. Infertility: Based on findings in animal toxicity studies, DATROWAY may impair male and female reproductive function and fertility. The effects on reproductive organs in animals were irreversible. Pediatric Use: Safety and effectiveness of DATROWAY have not been established in pediatric patients. Geriatric Use: Of the 365 patients in TROPION-Breast01 treated with DATROWAY 6 mg/kg, 25% were ≥65 years of age and 5% were ≥75 years of age. Grade ≥3 and serious adverse reactions were more common in patients ≥65 years (42% and 25%, respectively) compared to patients <65 years (33% and 15%, respectively). In TROPION-Breast01, no other meaningful differences in safety or efficacy were observed between patients ≥65 years of age versus younger patients. Renal Impairment: A higher incidence of ILD/pneumonitis has been observed in patients with mild and moderate renal impairment (creatinine clearance [CLcr] 30 to <90 mL/min). Monitor patients with renal impairment for increased adverse reactions, including respiratory reactions. No dosage adjustment is recommended in patients with mild to moderate renal impairment. The effect of severe renal impairment (CLcr <30 mL/min) on the pharmacokinetics of datopotamab deruxtecan-dlnk or DXd is unknown. Hepatic Impairment: No dosage adjustment is recommended in patients with mild hepatic impairment (total bilirubin ≤ULN and any AST >ULN or total bilirubin >1 to 1.5 times ULN and any AST). Limited data are available in patients with moderate hepatic impairment (total bilirubin >1.5 to 3 times ULN and any AST). Monitor patients with moderate hepatic impairment for increased adverse reactions. The recommended dosage of DATROWAY has not been established for patients with severe hepatic impairment (total bilirubin >3 times ULN and any AST). To report SUSPECTED ADVERSE REACTIONS, contact Daiichi Sankyo, Inc. at 1-877-437-7763 or FDA at 1-800-FDA-1088 or Please see accompanying full Prescribing Information, including the Medication Guide. About Daiichi Sankyo Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular and other diseases with high unmet medical need. For more information, please visit
Business Wire
an hour ago
- Business Wire
Introducing Tempus One in the EHR with Integrated Guidelines
CHICAGO--(BUSINESS WIRE)--Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine and patient care, today announced the expansion of Tempus One—its generative AI clinical assistant—with direct integration into electronic health record (EHR) systems. By integrating AI at every point of the clinical care process, the expanded capabilities of Tempus One offer physicians in oncology and beyond more support in treatment decisions. Tempus One is uniquely positioned to offer these new features given the company's depth and scale of EHR integrations with providers across the U.S. Tempus has developed an integrated architecture that captures real-time clinical, molecular and imaging data from millions of patients and makes that data easily digestible and useful for clinicians and care teams. Through Tempus One, physicians can gain AI-enabled insights that transform how they interact with patient data, streamlining complex treatment decisions and reducing time spent on administrative tasks. New capabilities in the latest iteration of Tempus One: Integration of ASCO Guidelines: Tempus One is integrating ASCO's clinical practice guidelines into the platform to equip physicians with the latest guidelines and information to guide personalized patient care. Oncologists are now able to easily access ASCO's guidelines, which provide evidence-based, treatment and care recommendations. Clinical Workflow Assistance: Tempus One has a suite of new features, designed to help physicians at every step with tailored insights and reduce the burden of administrative tasks. Pre-Appointment Preparation: Tempus One summarizes patient history, treatment journey, and recent biomarker status, ensuring physicians are well-prepared for appointments. Real-Time Support During Appointments: Tempus One can transcribe conversations, take intelligent notes, and highlight key information, allowing physicians to focus on patient care. Post-Appointment Assistance: Tempus One supports documentation tasks, treatment planning based on updated guidelines and research, prepares prior authorizations, and facilitates clinical trial matching. Agent Builder: Over the past several months, Tempus has used its Agent Builder GenAI tool internally to develop and deploy more than 1,000 AI agents. Now, Tempus is extending access to this toolset to a select group of partner providers, collaborating with them to create and test custom GenAI solutions tailored to their unique needs and preferences. The agents are designed to create efficiencies and streamline workflows, such as generating custom patient overviews to accelerate pre-charting or generating notes from conversations with patients to be added into their EHR records. These custom agents can be developed in collaboration with dedicated Tempus team members. By referencing institutions' standard operating procedures and data repositories, these agents can be seamlessly integrated into existing workflows through One. 'As healthcare faces rising costs and growing complexity, no group bears the burden more heavily than physicians and care teams,' said Ryan Fukushima, Chief Operating Officer at Tempus. 'This evolution of Tempus One represents a meaningful shift from a world where clinicians spend countless hours searching for answers and documenting care, to one where AI rapidly connects the dots across fragmented systems to deliver actionable insights in real time.' To learn more about Tempus One, view a video here and visit the website here. About Tempus Tempus is a technology company advancing precision medicine through the practical application of artificial intelligence in healthcare. With one of the world's largest libraries of multimodal data, and an operating system to make that data accessible and useful, Tempus provides AI-enabled precision medicine solutions to physicians to deliver personalized patient care and in parallel facilitates discovery, development and delivery of optimal therapeutics. The goal is for each patient to benefit from the treatment of others who came before by providing physicians with tools that learn as the company gathers more data. For more information, visit Forward Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the 'Securities Act'), and Section 21E of the Securities Exchange Act of 1934, as amended, about Tempus and Tempus' industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release are forward-looking statements, including, but not limited to, statements regarding the expected outcomes and benefits of Tempus One and its capabilities for customers. In some cases, you can identify forward-looking statements because they contain words such as 'anticipate,' 'believe,' 'contemplate,' 'continue,' 'could,' 'estimate,' 'expect,' 'going to,' 'intend,' 'may,' 'plan,' 'potential,' 'predict,' 'project,' 'should,' 'target,' 'will,' or 'would' or the negative of these words or other similar terms or expressions. Tempus cautions you that the foregoing may not include all of the forward-looking statements made in this press release. You should not rely on forward-looking statements as predictions of future events. Tempus has based the forward-looking statements contained in this press release primarily on its current expectations and projections about future events and trends that it believes may affect Tempus' business, financial condition, results of operations and prospects. These forward-looking statements are subject to risks and uncertainties related to: Tempus' financial performance; the ability to attract and retain customers and partners; managing Tempus' growth and future expenses; competition and new market entrants; compliance with new laws, regulations and executive actions, including any evolving regulations in the artificial intelligence space; the ability to maintain, protect and enhance Tempus' intellectual property; the ability to attract and retain qualified team members and key personnel; the ability to repay or refinance outstanding debt, or to access additional financing; future acquisitions, divestitures or investments; the potential adverse impact of climate change, natural disasters, health epidemics, macroeconomic conditions, and war or other armed conflict, as well as risks, uncertainties, and other factors described in the section titled 'Risk Factors' in Tempus' Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission ('SEC') on February 24, 2025, as well as in other filings Tempus may make with the SEC in the future. In addition, any forward-looking statements contained in this press release are based on assumptions that Tempus believes to be reasonable as of this date. Tempus undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of this press release or to reflect new information or the occurrence of unanticipated events, except as required by law.
Yahoo
an hour ago
- Yahoo
How Trump's Tariffs and Immigration Policies Could Make Housing Even More Expensive
President Donald Trump owes his second electoral victory, in no small part, to voter frustration over the rising cost of living. Over the course of Joe Biden's presidency, the price of a typical American house increased by nearly 40 percent, and rents followed a similar trajectory. As of 2024, approximately 771,480 Americans lack reliable shelter—at once a new high and a new low. All of these issues are most acute in states governed by Biden's fellow Democrats. In California, the median home price is now more than 10 times the median household income. Economists generally view three to five as a healthy ratio. Polling data suggest that many key voting blocs in the 2024 presidential election were primarily motivated by the rising cost of living and by out-of-control housing costs in particular. For all the network news preoccupation with transgender athletes and campus protests, it was mortgages and rents—the single largest line items in a typical household's budget—that moved voters to toss out incumbents. On April 2, after months of empty threats and false starts, the administration finally launched its global trade war, including a 25 percent tariff on various goods from Canada and Mexico. But Canadian softwood lumber and Mexican gypsum used for drywall—the (literal) pillars of a typical American single-family home—would be exempt. The National Association of Home Builders (NAHB) was quick to celebrate it as a win: Canada accounts for 85 percent of all U.S. lumber imports. If the tariffs had taken effect as planned, the per-unit cost of a home might have increased by as much as $29,000. In a sector characterized by thin margins, that would have meant a lot of idle construction sites. And yet the partial rollback will offer only a temporary reprieve. Tariffs already in effect will increase the cost of a new home by $10,900 on average, according to an April 2025 estimate by the NAHB—an increase of $1,700 over its March estimate. This is on top of a 41.6 percent increase in building materials since 2020, brought on by pandemic-related supply chain disruptions. Those cost increases could hit renters hardest. After a decade of underbuilding in the wake of the 2008 financial crisis, America is short roughly 5 million homes—most of them apartments. Perhaps the most robust finding in urban economics is that when vacancy rates increase, rents fall. But driving up vacancy rates requires cities to build more housing. Thanks to the YIMBY ("yes in my backyard") movement, a handful of cities—including Austin and Minneapolis—have recently had building booms that have brought prices back down. But those cities have been the exception. Meanwhile, a new wave of tariffs is about to make it a lot more expensive to build. On February 11, the administration imposed a 25 percent tariff on steel and aluminum—much of it imported from allies such as Brazil and Germany. On February 25, the administration announced an investigation into copper imports, presumably with future tariffs in the works. Depending on their country of origin, other key inputs like iron and cement are also now subject to steep tariffs. Even if you can get new housing built, the appliances needed to make all these new homes livable could soon cost hundreds of dollars more. Not only are microwaves, refrigerators, and air conditioners now more expensive to import, but tariffs on key inputs mean they are also more expensive to produce domestically. Uncertainty around tariffs has put many construction projects on pause, sending homebuilder stocks plummeting. Many small, local developers are exiting the market altogether. Following in the mold of autarkic Cuba—where international trade is strictly limited and medical doctors drive taxis for a living—your next Uber driver could very well be an out-of-work former developer. Never mind that the typical American city desperately needs them to build. If tariffs weren't bad enough, the administration's program of mass deportations could kick the housing crisis into overdrive. As things stand, the construction industry is already short 250,000 workers. This is partly a legacy of Trump's first term, in which an immigration clampdown suppressed what might have been an overdue housing construction boom. Even today, approximately 30 percent of construction workers are immigrants, many of them undocumented. In California, which is already a basket case on housing affordability, immigrants make up 41 percent of all construction labor. In Texas—one of the few bright spots for housing affordability in recent years, thanks to an ongoing construction boom—nearly 60 percent of all immigrant construction workers are undocumented. If 2024 was any indication, expecting voters to put up with all this in 2026 is a risky gamble. On some level, the Trump administration must appreciate that this is an existential threat. And yet its current proposals are out of sync with the scale of the housing crisis: Releasing more federally owned lands for housing development remains the only proposal the administration has seriously offered up to address the housing shortage. It's a fine enough idea if properly designed. But it would, at best, provide only modest relief to a handful of Western cities. Worse yet, the administration seems to have regressed to the implicitly regulatory "protect the suburbs" rhetoric that so failed Trump in the 2020 election. In February, Department of Housing and Urban Development (HUD) chief Scott Turner announced that he would be scrapping the Affirmatively Furthering Fair Housing (AFFH) rule in order to "cut red tape" and "advance market-driven development." Except the rule was essentially just a reporting exercise that required local governments to disclose—and ideally remove—local red tape standing in the way of housing. In 2018, then–HUD Secretary Ben Carson embraced the AFFH rule as a way of nudging cities to remove regulatory barriers to housing production, as part of his brief flirtation with YIMBYism. In a move that would make Orwell blush, Carson joined Trump in a Wall Street Journal op-ed two years later announcing that they would "protect America's suburbs" and scrap the rule if reelected. Trump lost that election. It's all a very strange state of affairs—a developer in chief with evidently little interest in getting America building again. It didn't need to be this way. Over the course of the first Trump administration, housing production recovered at a steady clip, with a muted increase in housing costs as a result. The administration's deregulating zeal could have been focused on unnecessary federal mandates that increase costs. Instead, the United States is poised to experience a run-up in housing prices through 2028 that could make the pandemic-era increases like a minor blip. So what could the federal government do? From a constitutional perspective, not much. The bulk of the blame for America's housing crisis lies with local governments that maintain onerous zoning regulations and unpredictable permitting processes—and the state governments that control them. The federal government has little role to play in zoning, even if it once did a lot of the heavy lifting to promote it. But that isn't to imply there is nothing the federal government could do. In recent years, the idea of tying federal dollars to local deregulation has gained acceptance within the Beltway. Bills with unsubtle names like the "Build More Housing Near Transit Act" or the "Yes In My Backyard Act" would variously condition money for transit or other public facilities on local jurisdictions cutting back on red tape. At the same time, the federal government could turn up the tax pressure. If homeowners in cities with high costs and low production were suddenly ineligible for benefits like the mortgage interest deduction or the state and local tax credit, it would transform the local politics of housing. Homeowners who might otherwise be fully bought into government constraints on housing production could flip their script. More likely, however, the onus will fall on state and local legislators to pull out all the stops on housing production. State and local elected officials can't control tariffs or immigration policy. But they can control "make or break" factors such as zoning regulations, permitting timelines, and impact fees. According to a recent RAND study, variations in these policies explain why it's nearly twice as expensive to build housing in California as in Texas. At least some state legislators are rising to the occasion. In recent months, states as diverse as Republican-supermajority Montana and Democratic-supermajority Washington have moved forward legislation restricting the right of local governments to block housing. Even California is starting to see the light. All these bills will help to get more housing built, no matter what's happening at the federal level. The Trump administration had better hope those state-level efforts are successful—and scrap the trade and immigration policies that could plunge America into another housing crisis. The post How Trump's Tariffs and Immigration Policies Could Make Housing Even More Expensive appeared first on
