View Future GrowthThis company listing is no longer activeThis company may still be operating, however this listing is no longer active. Find out why through their latest events.See Latest EventsQSAM Biosciences 過去の業績過去 基準チェック /06QSAM Biosciencesの収益は年間平均-28.5%の割合で減少していますが、 Biotechs業界の収益は年間 増加しています。収益は年間36.2% 25.4%割合で 減少しています。主要情報-28.49%収益成長率23.79%EPS成長率Biotechs 業界の成長17.04%収益成長率-25.39%株主資本利益率-653.40%ネット・マージンn/a前回の決算情報31 Dec 2023最近の業績更新更新なしすべての更新を表示Recent updatesお知らせ • May 04Telix Pharmaceuticals (Us) Inc. completed the acquisition of QSAM Biosciences, Inc. (OTCPK:QSAM) from Checkmate Capital Group LLC, Strategic Planning Assets Limited and others.Telix Pharmaceuticals (Us) Inc. signed a non-binding term sheet to acquire QSAM Biosciences, Inc. (OTCPK:QSAM) from Checkmate Capital Group LLC, Strategic Planning Assets Limited and others for $25.9 million on November 14, 2023. Telix Pharmaceuticals (Us) Inc. signed a definitive Agreement and Plan of Merger to acquire QSAM Biosciences, Inc. (OTCPK:QSAM) on February 7, 2024. Under the terms of the acquisition, Telix is expected to pay a total of $33.1 million in stock which is payable in the form of 4,369,914 Telix ordinary shares to be issued at closing and an earn-out of up to $90 million in contingent clinical and commercial milestone payments through a Contingent Value Rights (“CVR”) structure. Telix has also agreed to pay $2 million as collaboration and option fee to provide sixty days of exclusivity pending completion of diligence and execution of the Purchase Agreement. If the Proposed Acquisition does not close, the Collaboration Fee will be converted to Company common stock at $6.70 per share. The transaction is subject to the satisfactory completion of diligence by both parties, execution of definitive agreements, regulatory approval and approval by the QSAM shareholders, lock-up agreement among other conditions. QSAM stockholders representing greater than a majority of the total voting stock of the Company have approved the merger. The transaction is expected to close in the first quarter of 2024. PricewaterhouseCoopers acted as auditor to Telix Pharmaceuticals. Newbridge Securities Corporation acted as financial advisor and fairness opinion provider to QSAM. Transfer Online, Inc. acted as transfer agent to QSAM. Telix Pharmaceuticals (Us) Inc. completed the acquisition of QSAM Biosciences, Inc. (OTCPK:QSAM) from Checkmate Capital Group LLC, Strategic Planning Assets Limited and others on May 3, 2024.お知らせ • May 03QSAM Biosciences Files Form 15QSAM Biosciences, Inc. has announced that it has filed a Form 15 with the Securities and Exchange Commission to voluntarily deregister its common stock under the Securities Exchange Act of 1934, as amended. The par value of the company's common stock was $0.0001 per share.お知らせ • Nov 16Telix Pharmaceuticals Limited (ASX:TLX) signed a non-binding term sheet to acquire QSAM Biosciences, Inc. (OTCPK:QSAM) for $33.1 million.Telix Pharmaceuticals Limited (ASX:TLX) signed a non-binding term sheet to acquire QSAM Biosciences, Inc. (OTCPK:QSAM) for $33.1 million on November 14, 2023. Under the terms of the acquisition, Telix is expected to pay a total of $33.1 million in stock and up to $90 million in contingent clinical and commercial milestone payments through a Contingent Value Rights (“CVR”) structure. Telix has also agreed to pay $2 million as collaboration and option fee to provide sixty days of exclusivity pending completion of diligence and execution of the Purchase Agreement. If the Proposed Acquisition does not close, the Collaboration Fee will be converted to Company common stock at $6.70 per share. The transaction is subject to the satisfactory completion of diligence by both parties, execution of definitive agreements, and approval by the QSAM shareholders, lock-up agreement among other conditions and is expected to close in the first quarter of 2024.お知らせ • Oct 01QSAM Biosciences, Inc. announced that it has received $0.600001 million in fundingQSAM Biosciences, Inc. announced a private placement of 176,471 common shares at a price of $3.40 per share for gross proceeds of $600,000 on September 29, 2023. The transaction included participation from three accredited investors. All securities issued in the Offering, were sold pursuant to an exemption from registration under Section 4(a)(2) of the Securities Act of 1933 (the “Securities Act”). Securities issued in the Offering have not been registered under the Securities Act and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements. The transaction has been approved by the board of directors of the company.お知らせ • Jun 15QSAM Biosciences, Inc. Adds the Nuclear Reactor at the University of Texas at Austin to its Radioisotope Production Supply Chain for its Bone Cancer Treatment Drug Candidate, CycloSam®QSAM Biosciences Inc. announced the qualification and addition of the nuclear reactor at the University of Texas at Austin to its supply chain for the production of Samarium-153, the active radioisotope used in QSAM’s therapeutic radiopharmaceutical drug candidate, CycloSam® (Samarium-153 DOTMP), a potentially treatment for metastatic and primary bone cancer in adults and children. QSAM is actively enrolling patients with metastatic bone cancer in a Phase I clinical trial across four clinical research centers in the United States. The qualification of the nuclear reactor at UT-Austin, QSAM’s second qualified reactor, increases the availability of Samarium-153 and provides logistical efficiencies for the production and administration of CycloSam® for current and future clinical trials, as well as the commercial supply of CycloSam® if ultimately approved by the FDA. Samarium-153 (Sm-153) is a beta-emitting radioisotope that carries radiation designed and intended to disrupt tumor cell metabolism and cause cancer cell death. With a short 46-hour radiation half-life, Sm-153, in combination with the bone-seeking chelant DOTMP that is believed to significantly limit undesirable off-target migration of radiation to nearby healthy tissues, represents a potentially highly effective bone cancer treatment. The addition of qualified nuclear reactors is expected to support QSAM’s clinical research and future commercial supply of Sm-153 if approved by the FDA.お知らせ • May 24QSAM Biosciences Expands Its Study of Cyclosam(R) in the Treatment of Bone Cancer; Opens Patient Enrollment At Key Chicago Center, Insight Hospital and Medical CenterQSAM Biosciences Inc. announces the addition of the Insight Research Institute at the Insight Hospital and Medical Center in Chicago, IL, as a clinical trial site approved to begin enrolling participants into the Phase 1 study evaluating CycloSam® in patients with multiple types of bone cancer that either originated in or has metastasized to the bone. QSAM’s study is a multiple center, open label, dose escalation clinical trial intended to determine the maximum tolerated dose of CycloSam® in patients, as well as assess early efficacy signals. Patients with bone cancer that has metastasized from the breast, lungs, prostate or other organs, as well as patients with cancer that has originated in the bone such as osteosarcoma and Ewing’s Sarcoma – diseases that mostly affect children and young adults may be eligible.お知らせ • Jul 14QSAM Biosciences, Inc. Receives Third U.S. Patent for Clinical-Stage Radiopharmaceutical Drug Candidate CycloSamQSAM Biosciences Inc. announced that the United States Patent & Trademark Office has granted a key patent protecting how CycloSam is formulated and prepared, namely by using a nonradioactive kit that can be delivered and stored local to the administration site and provides for high purity in an efficient, facile and reproducible process at lower costs. This patent covers both formulation and preparation of CycloSam in the U.S. with DOTMP kit formulations for radioisotope delivery targeting bone tumors, as well the high-dosage use of the radiopharmaceutical to perform bone marrow ablations. The scope of this patent is fairly broad in that it not only protects the use of QSAM’s primary radioisotope, Samarium-153 (Sm-153), but also several other radioactive materials used in commercialized radiopharmaceuticals such as Lutetium-177 (Lu-177) and Yttrium-90 (Y-90) in conjunction with the chelating agent DOTMP. This patent provides the potential to add additional radiopharmaceuticals to QSAM’s pipeline. The kit itself is designed to provide convenient and reproducible preparation of the drug with better delivery and higher purity for each specific formulation.お知らせ • Apr 13QSAM Biosciences Inc. Receives Japanese Patent for Its Clinical Stage Radiopharmaceutical Drug Candidate, CyclosamQSAM Biosciences Inc. announced that the Japan Patent Office has granted a key patent that protects the use of “lower specific activity” Samarium-153 in conjunction with the treatment of bone cancer in children and adults. This patent covers within the Japanese market the “high purity therapeutic bone agents” technology exclusively licensed to QSAM on a worldwide basis, and relates to the novel manner in which the Samarium-153 used in CycloSam is produced. That process reduces long-lived impurities -- namely Europium-154 -- which may allow for higher and multiple dosing regimens in the treatment of different types of bone cancer, including cancer that has metastasized from the lung, breast or prostate. Those types of metastasized bone cancer are the subject of QSAM’s current FDA-cleared Phase 1 clinical trial, which has already begun recruiting and screening patients. Management believes that multi-dosing regimens may be the key to CycloSam being able to successfully treat bone tumors, and is advancing it clinical trials toward that goal.お知らせ • Mar 07+ 1 more updateQSAM Biosciences, Inc. Appoints Adam King as Chief Financial Officer of the CompanyQSAM Biosciences, Inc. announced that on March 3, 2022, the Company appointed Adam King to serve as Chief Financial Officer of the Company. Since December 6, 2021, Mr. King served as Interim CFO for the Company. Mr. King is the founder and CEO of King Consulting Group, where he provides a range of financial and reporting services for clients that range from large private equity-backed international companies to small start-ups.お知らせ • Feb 03Qsam Biosciences Inc. Receives Rare Pediatric Disease Designation from FDA for Cyclosam in the Treatment of OsteosarcomaQSAM Biosciences, Inc. announced that the United States Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to QSAM’s clinical-stage drug candidate, CycloSam®, for the treatment osteosarcoma, a devastating form of bone cancer that afflicts mostly children and young adults. Rare Pediatric Disease Designation (RPDD), defined as diseases primarily affecting fewer than 200,000 Americans under the age of 18 each year, may provide substantial financial incentives by making companies eligible for a Priority Review Voucher (PRV) upon drug approval by the FDA. A PRV grants accelerated FDA review of a drug candidate for any indication, reducing the review period to 6 months and potentially gaining early market access. PRVs may be used by the recipient company for any drug development program, or alternatively, sold or transferred to larger pharmaceutical companies. Osteosarcoma is the most common form of bone cancer in children and young adults with primary high-grade bone malignancy. There have been few advancements over the last 40 years for this debilitating and often deadly disease, with treatment often resulting in limb amputation. Accordingly, there is a large unmet market need for a better treatment that is more efficacious against pediatric osteosarcoma and better tolerated by patients. In August 2021, the Company received orphan designation for CycloSam for the indication of osteosarcoma. Orphan Drug Designation (ODD) affords QSAM certain additional benefits, including tax credits for qualified clinical testing, waiver or partial payment of FDA application fees, and seven years of market exclusivity, if approved.お知らせ • Dec 02QSAM Biosciences, Inc. Activates Clinical Sites and Opens Enrollment for its Phase 1 Clinical Trial of CycloSam® for the Treatment of Bone CancerQSAM Biosciences Inc. announced the activation of its first clinical trial site and the initiation of enrollment of patients into its Phase 1 clinical trial evaluating CycloSam® for multiple types of bone cancer that either originated in or has metastasized to the bone. The Company’s initial enrollment site is at Oncology Consultants in Houston, TX. The Phase 1 multi-center dose escalation trial is designed to determine the maximum tolerated dose of CycloSam® in patients, with the additional goal of assessing early efficacy markers. Patients with bone cancer that has migrated or metastasized from the prostate, breast, lung or other organs are eligible for enrollment. According to the American Cancer Society there are about 400,000 new cases of malignant bone metastasis diagnosed in the United States each year.お知らせ • Aug 26QSAM Biosciences Announces FDA Clearance of IND for Samarium-153 DOTMP, an Investigational Radiopharmaceutical for the Treatment of Bone CancerQSAM Biosciences Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared QSAM’s investigational new drug (IND) application which allows the Company to commence Phase 1 clinical trials and the dosing of patients with bone cancer. CycloSam is expected to be a significantly improved formulation of a previously FDA-approved radiopharmaceutical. This novel drug candidate utilizes both a more efficient method of isotope manufacturing and an advanced chelation technology which may potentially allow for repeated dosing of patients with bone cancer in an effort to halt or reverse tumor growth.お知らせ • Aug 18QSAM Biosciences, Inc. announced delayed 10-Q filingOn 08/17/2021, QSAM Biosciences, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC.お知らせ • May 18QSAM Biosciences, Inc. announced delayed 10-Q filingOn 05/17/2021, QSAM Biosciences, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC.お知らせ • May 05QSAM Biosciences Announces Submission of IND Application for CycloSam® with FDAQSAM Biosciences Inc. announced that it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1 clinical trial of Samarium-153 DOTMP (CycloSam®) in patients with bone cancer. The IND submission was submitted fully electronically, was compliant with all current FDA electronic document requirements, and was accepted for review by the FDA. The first proposed clinical trial included in the IND is a dose escalation and dose finding study of CycloSam to treat solid tumor(s) in the bone or metastatic to the bone. A wide group of all tumors metastatic to the bone from prostate, lung, and breast cancer are proposed to be eligible for this clinical trial. In parallel with this regulatory submission, the Company has contracted with a well-established contract research organization (CRO) and is actively recruiting investigators and clinical trial sites to participate in this study, and expects to begin enrolling patients mid-year. The FDA has already cleared an investigator-initiated IND for CycloSam for the treatment of osteosarcoma, and a second single-patient IND in 2020 for a bone marrow ablation procedure prior to stem cell transplantation.お知らせ • Apr 03QSAM Biosciences, Inc. announced delayed annual 10-K filingOn 04/01/2021, QSAM Biosciences, Inc. announced that they will be unable to file their next 10-K by the deadline required by the SEC.お知らせ • Feb 17QSAM Biosciences, Inc. Appoints Charles J. Link, Jr., M.D. to Board of DirectorsQSAM Biosciences Inc. announced that it has appointed Charles J. Link Jr, M.D., to its Board of Directors effective February 15, 2021. In addition to his role on the Board, Dr. Link will serve part-time as the Company’s Medical Director. Dr. Link brings decades of biotech and drug development experience to QSAM. He currently serves on the executive committee of the Board of Directors at NovaScan Inc.お知らせ • Jan 29QSAM Biosciences, Inc. announced that it has received $2.5 million in funding from Checkmate Capital Group LLCOn January 27, 2021, QSAM Biosciences, Inc. (OTCPK:QSAM) closed the transaction. The transaction was led by new investor, Checkmate Capital Group LLC. The preferred shares are convertible into 16,600,000 sharesお知らせ • Jan 22QSAM Biosciences, Inc. Receives Favorable Safety Results in Study for Its Leading Radiopharmaceutical Drug CandidateQSAM Biosciences Inc. announced favorable results from a study to evaluate the radioactive impurity levels in its drug candidate Samarium-153-DOTMP (aka CycloSam®). The results of this study are positive indicators about the safety profile and potential expanded uses of CycloSam if ultimately approved for commercial usage by the U.S. Food and Drug Administration (FDA). The study, conducted by leading radiopharmaceutical research firm, IsoTherapeutics Group, LLC, confirmed that the long-lived radionuclidic impurities of Europium-154 (Eu-154) in CycloSam are decreased over 40-fold to nearly non-detectable levels from those reported for a similar adiopharmaceutical product previously approved by the FDA for commercial usage. The findings also indicate significantly less buildup of these impurities, which enhances the clinical utility of CycloSam, potentially allowing safe, multiple dosing regimens, and possibly leading to broader therapeutic applications across multiple indications. QSAM expects to enter Phase 1 clinical trials for CycloSam in the first half of this year. The company, through its exclusive, worldwide license agreement with IsoTherapeutics Group, has issued patents that encompasses Sm-153 and reduced Europium-154 impurity via its ‘High purity therapeutic bone agents’ patents. Technical Information on Eu-154 Impurities: Radionuclidic impurities arise from the production process or the decay of the primary radioisotopes used in radiopharmaceuticals and are of particular concern to clinicians and patients due to the resulting increase in radiation dose received by the patient. Samarium-153 is prepared in a nuclear reactor and, in the process, generates radioactive Eu-154. Eu-154 is present in FDA-approved and clinically utilized products, and there are significant limitations and safety concerns associated with its higher level of impurities because of its long half-life of 8.8 years. Eu-154 administered to a patient can result in the isotope giving an undesirable dose to a patient, essentially irradiating at them at a lower level for years. CycloSam® Sm-153-DOTMP also uses Sm-153 as the isotope, however, due to DOTMP’s superior ability to chelate Sm, it can be formulated with lower specific activity Sm-153. This Sm-153 is irradiated in a beryllium reflector area of the reactor for a shorter period of time, resulting in low or negligible radionuclidic impurities.お知らせ • Jan 02QSAM Biosciences, Inc. Announces the Resignation of Tristan Peitz as DirectorOn December 9, 2020, Tristan Peitz resigned as Director of QSAM Biosciences, Inc. The resignation was for personal reasons.お知らせ • Nov 18QSAM Biosciences, Inc. announced delayed 10-Q filingOn 11/16/2020, QSAM Biosciences, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC.お知らせ • Nov 11QSAM Biosciences, Inc. Announces Executive ChangesQSAM Biosciences, Inc. on November 6, 2020, Kevin Bolin resigned as Chairman of the Company. The resignation was by mutual agreement. On November 6, 2020, C. Richard Piazza, age 73, was appointed as a Member of and the Executive Chairman of the Board of the Company. Mr. Piazza has more than 45 years of healthcare experience in both medical devices and pharmaceutical/biotech, and has led several technology companies to market success including numerous FDA approvals in both sectors. During his career running both public and private companies he has raised more than a $120 million in capital. Mr. Piazza also serves as President, and is a minority shareholder, of IGL Pharma Inc., the licensor of the Company's drug technology, and a consultant to IsoTherapeutics Group, LLC, the inventors of the technology.収支内訳QSAM Biosciences の稼ぎ方とお金の使い方。LTMベースの直近の報告された収益に基づく。収益と収入の歴史OTCPK:QSAM 収益、費用、利益 ( )USD Millions日付収益収益G+A経費研究開発費31 Dec 230-53130 Sep 230-63130 Jun 230-64131 Mar 230-64131 Dec 220-64130 Sep 220-87130 Jun 220-97131 Mar 220-109131 Dec 210-1410130 Sep 210-127130 Jun 210-126031 Mar 210-104031 Dec 200-61030 Sep 20-1-41030 Jun 200-11031 Mar 200-11031 Dec 190-11030 Sep 19102030 Jun 190-12031 Mar 190-12031 Dec 18002030 Sep 180-31030 Jun 180-21031 Mar 180-31031 Dec 170-31030 Sep 170-21030 Jun 170-21031 Mar 17001031 Dec 160-22030 Sep 160-22130 Jun 160-22131 Mar 160-42131 Dec 150-42130 Sep 150-321質の高い収益: QSAMは現在利益が出ていません。利益率の向上: QSAMは現在利益が出ていません。フリー・キャッシュフローと収益の比較過去の収益成長分析収益動向: QSAMは利益が出ておらず、過去 5 年間で損失は年間28.5%の割合で増加しています。成長の加速: QSAMの過去 1 年間の収益成長を 5 年間の平均と比較することはできません。現在は利益が出ていないためです。収益対業界: QSAMは利益が出ていないため、過去 1 年間の収益成長をBiotechs業界 ( 54.5% ) と比較することは困難です。株主資本利益率高いROE: QSAMは現在利益が出ていないため、自己資本利益率 ( -653.4% ) はマイナスです。総資産利益率使用総資本利益率過去の好業績企業の発掘7D1Y7D1Y7D1YPharmaceuticals-biotech 、過去の業績が好調な企業。View Financial Health企業分析と財務データの現状データ最終更新日（UTC時間）企業分析2024/05/02 18:17終値2024/05/02 00:00収益2023/12/31年間収益2023/12/31データソース企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。パッケージデータタイムフレーム米国ソース例会社財務10年損益計算書キャッシュ・フロー計算書貸借対照表SECフォーム10-KSECフォーム10-Qアナリストのコンセンサス予想+プラス3年予想財務アナリストの目標株価アナリストリサーチレポートBlue Matrix市場価格30年株価配当、分割、措置ICEマーケットデータSECフォームS-1所有権10年トップ株主インサイダー取引SECフォーム4SECフォーム13Dマネジメント10年リーダーシップ・チーム取締役会SECフォーム10-KSECフォームDEF 14A主な進展10年会社からのお知らせSECフォーム8-K* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM（Trailing Twelve Month）またはLTM（Last Twelve Month）データとして知られています。詳細はこちら。分析モデルとスノーフレーク本レポートを生成するために使用した分析モデルの詳細は当社のGithubページでご覧いただけます。また、レポートの使用方法に関するガイドやYoutubeのチュートリアルも掲載しています。シンプリー・ウォールストリート分析モデルを設計・構築した世界トップクラスのチームについてご紹介します。業界およびセクターの指標私たちの業界とセクションの指標は、Simply Wall Stによって6時間ごとに計算されます。アナリスト筋QSAM Biosciences, Inc. 0 これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。0
お知らせ • May 04Telix Pharmaceuticals (Us) Inc. completed the acquisition of QSAM Biosciences, Inc. (OTCPK:QSAM) from Checkmate Capital Group LLC, Strategic Planning Assets Limited and others.Telix Pharmaceuticals (Us) Inc. signed a non-binding term sheet to acquire QSAM Biosciences, Inc. (OTCPK:QSAM) from Checkmate Capital Group LLC, Strategic Planning Assets Limited and others for $25.9 million on November 14, 2023. Telix Pharmaceuticals (Us) Inc. signed a definitive Agreement and Plan of Merger to acquire QSAM Biosciences, Inc. (OTCPK:QSAM) on February 7, 2024. Under the terms of the acquisition, Telix is expected to pay a total of $33.1 million in stock which is payable in the form of 4,369,914 Telix ordinary shares to be issued at closing and an earn-out of up to $90 million in contingent clinical and commercial milestone payments through a Contingent Value Rights (“CVR”) structure. Telix has also agreed to pay $2 million as collaboration and option fee to provide sixty days of exclusivity pending completion of diligence and execution of the Purchase Agreement. If the Proposed Acquisition does not close, the Collaboration Fee will be converted to Company common stock at $6.70 per share. The transaction is subject to the satisfactory completion of diligence by both parties, execution of definitive agreements, regulatory approval and approval by the QSAM shareholders, lock-up agreement among other conditions. QSAM stockholders representing greater than a majority of the total voting stock of the Company have approved the merger. The transaction is expected to close in the first quarter of 2024. PricewaterhouseCoopers acted as auditor to Telix Pharmaceuticals. Newbridge Securities Corporation acted as financial advisor and fairness opinion provider to QSAM. Transfer Online, Inc. acted as transfer agent to QSAM. Telix Pharmaceuticals (Us) Inc. completed the acquisition of QSAM Biosciences, Inc. (OTCPK:QSAM) from Checkmate Capital Group LLC, Strategic Planning Assets Limited and others on May 3, 2024.
お知らせ • May 03QSAM Biosciences Files Form 15QSAM Biosciences, Inc. has announced that it has filed a Form 15 with the Securities and Exchange Commission to voluntarily deregister its common stock under the Securities Exchange Act of 1934, as amended. The par value of the company's common stock was $0.0001 per share.
お知らせ • Nov 16Telix Pharmaceuticals Limited (ASX:TLX) signed a non-binding term sheet to acquire QSAM Biosciences, Inc. (OTCPK:QSAM) for $33.1 million.Telix Pharmaceuticals Limited (ASX:TLX) signed a non-binding term sheet to acquire QSAM Biosciences, Inc. (OTCPK:QSAM) for $33.1 million on November 14, 2023. Under the terms of the acquisition, Telix is expected to pay a total of $33.1 million in stock and up to $90 million in contingent clinical and commercial milestone payments through a Contingent Value Rights (“CVR”) structure. Telix has also agreed to pay $2 million as collaboration and option fee to provide sixty days of exclusivity pending completion of diligence and execution of the Purchase Agreement. If the Proposed Acquisition does not close, the Collaboration Fee will be converted to Company common stock at $6.70 per share. The transaction is subject to the satisfactory completion of diligence by both parties, execution of definitive agreements, and approval by the QSAM shareholders, lock-up agreement among other conditions and is expected to close in the first quarter of 2024.
お知らせ • Oct 01QSAM Biosciences, Inc. announced that it has received $0.600001 million in fundingQSAM Biosciences, Inc. announced a private placement of 176,471 common shares at a price of $3.40 per share for gross proceeds of $600,000 on September 29, 2023. The transaction included participation from three accredited investors. All securities issued in the Offering, were sold pursuant to an exemption from registration under Section 4(a)(2) of the Securities Act of 1933 (the “Securities Act”). Securities issued in the Offering have not been registered under the Securities Act and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements. The transaction has been approved by the board of directors of the company.
お知らせ • Jun 15QSAM Biosciences, Inc. Adds the Nuclear Reactor at the University of Texas at Austin to its Radioisotope Production Supply Chain for its Bone Cancer Treatment Drug Candidate, CycloSam®QSAM Biosciences Inc. announced the qualification and addition of the nuclear reactor at the University of Texas at Austin to its supply chain for the production of Samarium-153, the active radioisotope used in QSAM’s therapeutic radiopharmaceutical drug candidate, CycloSam® (Samarium-153 DOTMP), a potentially treatment for metastatic and primary bone cancer in adults and children. QSAM is actively enrolling patients with metastatic bone cancer in a Phase I clinical trial across four clinical research centers in the United States. The qualification of the nuclear reactor at UT-Austin, QSAM’s second qualified reactor, increases the availability of Samarium-153 and provides logistical efficiencies for the production and administration of CycloSam® for current and future clinical trials, as well as the commercial supply of CycloSam® if ultimately approved by the FDA. Samarium-153 (Sm-153) is a beta-emitting radioisotope that carries radiation designed and intended to disrupt tumor cell metabolism and cause cancer cell death. With a short 46-hour radiation half-life, Sm-153, in combination with the bone-seeking chelant DOTMP that is believed to significantly limit undesirable off-target migration of radiation to nearby healthy tissues, represents a potentially highly effective bone cancer treatment. The addition of qualified nuclear reactors is expected to support QSAM’s clinical research and future commercial supply of Sm-153 if approved by the FDA.
お知らせ • May 24QSAM Biosciences Expands Its Study of Cyclosam(R) in the Treatment of Bone Cancer; Opens Patient Enrollment At Key Chicago Center, Insight Hospital and Medical CenterQSAM Biosciences Inc. announces the addition of the Insight Research Institute at the Insight Hospital and Medical Center in Chicago, IL, as a clinical trial site approved to begin enrolling participants into the Phase 1 study evaluating CycloSam® in patients with multiple types of bone cancer that either originated in or has metastasized to the bone. QSAM’s study is a multiple center, open label, dose escalation clinical trial intended to determine the maximum tolerated dose of CycloSam® in patients, as well as assess early efficacy signals. Patients with bone cancer that has metastasized from the breast, lungs, prostate or other organs, as well as patients with cancer that has originated in the bone such as osteosarcoma and Ewing’s Sarcoma – diseases that mostly affect children and young adults may be eligible.
お知らせ • Jul 14QSAM Biosciences, Inc. Receives Third U.S. Patent for Clinical-Stage Radiopharmaceutical Drug Candidate CycloSamQSAM Biosciences Inc. announced that the United States Patent & Trademark Office has granted a key patent protecting how CycloSam is formulated and prepared, namely by using a nonradioactive kit that can be delivered and stored local to the administration site and provides for high purity in an efficient, facile and reproducible process at lower costs. This patent covers both formulation and preparation of CycloSam in the U.S. with DOTMP kit formulations for radioisotope delivery targeting bone tumors, as well the high-dosage use of the radiopharmaceutical to perform bone marrow ablations. The scope of this patent is fairly broad in that it not only protects the use of QSAM’s primary radioisotope, Samarium-153 (Sm-153), but also several other radioactive materials used in commercialized radiopharmaceuticals such as Lutetium-177 (Lu-177) and Yttrium-90 (Y-90) in conjunction with the chelating agent DOTMP. This patent provides the potential to add additional radiopharmaceuticals to QSAM’s pipeline. The kit itself is designed to provide convenient and reproducible preparation of the drug with better delivery and higher purity for each specific formulation.
お知らせ • Apr 13QSAM Biosciences Inc. Receives Japanese Patent for Its Clinical Stage Radiopharmaceutical Drug Candidate, CyclosamQSAM Biosciences Inc. announced that the Japan Patent Office has granted a key patent that protects the use of “lower specific activity” Samarium-153 in conjunction with the treatment of bone cancer in children and adults. This patent covers within the Japanese market the “high purity therapeutic bone agents” technology exclusively licensed to QSAM on a worldwide basis, and relates to the novel manner in which the Samarium-153 used in CycloSam is produced. That process reduces long-lived impurities -- namely Europium-154 -- which may allow for higher and multiple dosing regimens in the treatment of different types of bone cancer, including cancer that has metastasized from the lung, breast or prostate. Those types of metastasized bone cancer are the subject of QSAM’s current FDA-cleared Phase 1 clinical trial, which has already begun recruiting and screening patients. Management believes that multi-dosing regimens may be the key to CycloSam being able to successfully treat bone tumors, and is advancing it clinical trials toward that goal.
お知らせ • Mar 07+ 1 more updateQSAM Biosciences, Inc. Appoints Adam King as Chief Financial Officer of the CompanyQSAM Biosciences, Inc. announced that on March 3, 2022, the Company appointed Adam King to serve as Chief Financial Officer of the Company. Since December 6, 2021, Mr. King served as Interim CFO for the Company. Mr. King is the founder and CEO of King Consulting Group, where he provides a range of financial and reporting services for clients that range from large private equity-backed international companies to small start-ups.
お知らせ • Feb 03Qsam Biosciences Inc. Receives Rare Pediatric Disease Designation from FDA for Cyclosam in the Treatment of OsteosarcomaQSAM Biosciences, Inc. announced that the United States Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to QSAM’s clinical-stage drug candidate, CycloSam®, for the treatment osteosarcoma, a devastating form of bone cancer that afflicts mostly children and young adults. Rare Pediatric Disease Designation (RPDD), defined as diseases primarily affecting fewer than 200,000 Americans under the age of 18 each year, may provide substantial financial incentives by making companies eligible for a Priority Review Voucher (PRV) upon drug approval by the FDA. A PRV grants accelerated FDA review of a drug candidate for any indication, reducing the review period to 6 months and potentially gaining early market access. PRVs may be used by the recipient company for any drug development program, or alternatively, sold or transferred to larger pharmaceutical companies. Osteosarcoma is the most common form of bone cancer in children and young adults with primary high-grade bone malignancy. There have been few advancements over the last 40 years for this debilitating and often deadly disease, with treatment often resulting in limb amputation. Accordingly, there is a large unmet market need for a better treatment that is more efficacious against pediatric osteosarcoma and better tolerated by patients. In August 2021, the Company received orphan designation for CycloSam for the indication of osteosarcoma. Orphan Drug Designation (ODD) affords QSAM certain additional benefits, including tax credits for qualified clinical testing, waiver or partial payment of FDA application fees, and seven years of market exclusivity, if approved.
お知らせ • Dec 02QSAM Biosciences, Inc. Activates Clinical Sites and Opens Enrollment for its Phase 1 Clinical Trial of CycloSam® for the Treatment of Bone CancerQSAM Biosciences Inc. announced the activation of its first clinical trial site and the initiation of enrollment of patients into its Phase 1 clinical trial evaluating CycloSam® for multiple types of bone cancer that either originated in or has metastasized to the bone. The Company’s initial enrollment site is at Oncology Consultants in Houston, TX. The Phase 1 multi-center dose escalation trial is designed to determine the maximum tolerated dose of CycloSam® in patients, with the additional goal of assessing early efficacy markers. Patients with bone cancer that has migrated or metastasized from the prostate, breast, lung or other organs are eligible for enrollment. According to the American Cancer Society there are about 400,000 new cases of malignant bone metastasis diagnosed in the United States each year.
お知らせ • Aug 26QSAM Biosciences Announces FDA Clearance of IND for Samarium-153 DOTMP, an Investigational Radiopharmaceutical for the Treatment of Bone CancerQSAM Biosciences Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared QSAM’s investigational new drug (IND) application which allows the Company to commence Phase 1 clinical trials and the dosing of patients with bone cancer. CycloSam is expected to be a significantly improved formulation of a previously FDA-approved radiopharmaceutical. This novel drug candidate utilizes both a more efficient method of isotope manufacturing and an advanced chelation technology which may potentially allow for repeated dosing of patients with bone cancer in an effort to halt or reverse tumor growth.
お知らせ • Aug 18QSAM Biosciences, Inc. announced delayed 10-Q filingOn 08/17/2021, QSAM Biosciences, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC.
お知らせ • May 18QSAM Biosciences, Inc. announced delayed 10-Q filingOn 05/17/2021, QSAM Biosciences, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC.
お知らせ • May 05QSAM Biosciences Announces Submission of IND Application for CycloSam® with FDAQSAM Biosciences Inc. announced that it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1 clinical trial of Samarium-153 DOTMP (CycloSam®) in patients with bone cancer. The IND submission was submitted fully electronically, was compliant with all current FDA electronic document requirements, and was accepted for review by the FDA. The first proposed clinical trial included in the IND is a dose escalation and dose finding study of CycloSam to treat solid tumor(s) in the bone or metastatic to the bone. A wide group of all tumors metastatic to the bone from prostate, lung, and breast cancer are proposed to be eligible for this clinical trial. In parallel with this regulatory submission, the Company has contracted with a well-established contract research organization (CRO) and is actively recruiting investigators and clinical trial sites to participate in this study, and expects to begin enrolling patients mid-year. The FDA has already cleared an investigator-initiated IND for CycloSam for the treatment of osteosarcoma, and a second single-patient IND in 2020 for a bone marrow ablation procedure prior to stem cell transplantation.
お知らせ • Apr 03QSAM Biosciences, Inc. announced delayed annual 10-K filingOn 04/01/2021, QSAM Biosciences, Inc. announced that they will be unable to file their next 10-K by the deadline required by the SEC.
お知らせ • Feb 17QSAM Biosciences, Inc. Appoints Charles J. Link, Jr., M.D. to Board of DirectorsQSAM Biosciences Inc. announced that it has appointed Charles J. Link Jr, M.D., to its Board of Directors effective February 15, 2021. In addition to his role on the Board, Dr. Link will serve part-time as the Company’s Medical Director. Dr. Link brings decades of biotech and drug development experience to QSAM. He currently serves on the executive committee of the Board of Directors at NovaScan Inc.
お知らせ • Jan 29QSAM Biosciences, Inc. announced that it has received $2.5 million in funding from Checkmate Capital Group LLCOn January 27, 2021, QSAM Biosciences, Inc. (OTCPK:QSAM) closed the transaction. The transaction was led by new investor, Checkmate Capital Group LLC. The preferred shares are convertible into 16,600,000 shares
お知らせ • Jan 22QSAM Biosciences, Inc. Receives Favorable Safety Results in Study for Its Leading Radiopharmaceutical Drug CandidateQSAM Biosciences Inc. announced favorable results from a study to evaluate the radioactive impurity levels in its drug candidate Samarium-153-DOTMP (aka CycloSam®). The results of this study are positive indicators about the safety profile and potential expanded uses of CycloSam if ultimately approved for commercial usage by the U.S. Food and Drug Administration (FDA). The study, conducted by leading radiopharmaceutical research firm, IsoTherapeutics Group, LLC, confirmed that the long-lived radionuclidic impurities of Europium-154 (Eu-154) in CycloSam are decreased over 40-fold to nearly non-detectable levels from those reported for a similar adiopharmaceutical product previously approved by the FDA for commercial usage. The findings also indicate significantly less buildup of these impurities, which enhances the clinical utility of CycloSam, potentially allowing safe, multiple dosing regimens, and possibly leading to broader therapeutic applications across multiple indications. QSAM expects to enter Phase 1 clinical trials for CycloSam in the first half of this year. The company, through its exclusive, worldwide license agreement with IsoTherapeutics Group, has issued patents that encompasses Sm-153 and reduced Europium-154 impurity via its ‘High purity therapeutic bone agents’ patents. Technical Information on Eu-154 Impurities: Radionuclidic impurities arise from the production process or the decay of the primary radioisotopes used in radiopharmaceuticals and are of particular concern to clinicians and patients due to the resulting increase in radiation dose received by the patient. Samarium-153 is prepared in a nuclear reactor and, in the process, generates radioactive Eu-154. Eu-154 is present in FDA-approved and clinically utilized products, and there are significant limitations and safety concerns associated with its higher level of impurities because of its long half-life of 8.8 years. Eu-154 administered to a patient can result in the isotope giving an undesirable dose to a patient, essentially irradiating at them at a lower level for years. CycloSam® Sm-153-DOTMP also uses Sm-153 as the isotope, however, due to DOTMP’s superior ability to chelate Sm, it can be formulated with lower specific activity Sm-153. This Sm-153 is irradiated in a beryllium reflector area of the reactor for a shorter period of time, resulting in low or negligible radionuclidic impurities.
お知らせ • Jan 02QSAM Biosciences, Inc. Announces the Resignation of Tristan Peitz as DirectorOn December 9, 2020, Tristan Peitz resigned as Director of QSAM Biosciences, Inc. The resignation was for personal reasons.
お知らせ • Nov 18QSAM Biosciences, Inc. announced delayed 10-Q filingOn 11/16/2020, QSAM Biosciences, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC.
お知らせ • Nov 11QSAM Biosciences, Inc. Announces Executive ChangesQSAM Biosciences, Inc. on November 6, 2020, Kevin Bolin resigned as Chairman of the Company. The resignation was by mutual agreement. On November 6, 2020, C. Richard Piazza, age 73, was appointed as a Member of and the Executive Chairman of the Board of the Company. Mr. Piazza has more than 45 years of healthcare experience in both medical devices and pharmaceutical/biotech, and has led several technology companies to market success including numerous FDA approvals in both sectors. During his career running both public and private companies he has raised more than a $120 million in capital. Mr. Piazza also serves as President, and is a minority shareholder, of IGL Pharma Inc., the licensor of the Company's drug technology, and a consultant to IsoTherapeutics Group, LLC, the inventors of the technology.