Latest news with #ChimericAntigenReceptor
Time of India
5 days ago
- Health
- Time of India
MGM successfully treats blood cancer patient with CAR T-Cell therapy
Indore: MGM Medical College on Saturday announced its successful treatment of a blood cancer patient using CAR T-cell therapy, making it the first govt medical institution in the state to do so. Tired of too many ads? go ad free now "The groundbreaking treatment was carried out under the supervision of department of clinical haematology, transfusion medicine, and bone marrow transplant," MGMMC dean Dr Arvind Ghanghoria said. He added that the patient, whose treatment began on Jan 26 this year at the Super Speciality Hospital, was successfully discharged on Saturday, four months after the therapy. Explained the CAR T-cell therapy process, Dr Ghanghoria said, "The patient undergoes an apheresis procedure to remove white blood cells. A normal patient's blood contains two types of white blood cells, B and T cells. T cells are separated from the white blood cells and then genetically modified using viral vectors. These genetically modified CAR T-cells are then re-infused into the patient. The Chimeric Antigen Receptor identifies specific proteins on the surface of cancer cells and destroys them. In this way, CAR T-cells eliminate cancer from the patient's body, leading to a cancer-free life," he said. Head of clinical haematology department Dr Akshay Lahoti highlighted that similar CAR T-cell therapy treatments abroad can cost up to Rs 4 crore. He extended gratitude for the extensive support received from various individuals and organisations, including Dr Rahul Bhargava (head haematologist, Fortis Hospital), Dr Sudhir Kataria, Dr Preeti Malpani, Dr Prachi Chaudhary, Dr Ashok Yadav, Dr Sumit Shukla, and others. Tired of too many ads? go ad free now Indore: MGM Medical College on Saturday announced its successful treatment of a blood cancer patient using CAR T-cell therapy, making it the first govt medical institution in the state to do so. "The groundbreaking treatment was carried out under the supervision of department of clinical haematology, transfusion medicine, and bone marrow transplant," MGMMC dean Dr Arvind Ghanghoria said. He added that the patient, whose treatment began on Jan 26 this year at the Super Speciality Hospital, was successfully discharged on Saturday, four months after the therapy. Explained the CAR T-cell therapy process, Dr Ghanghoria said, "The patient undergoes an apheresis procedure to remove white blood cells. A normal patient's blood contains two types of white blood cells, B and T cells. T cells are separated from the white blood cells and then genetically modified using viral vectors. These genetically modified CAR T-cells are then re-infused into the patient. The Chimeric Antigen Receptor identifies specific proteins on the surface of cancer cells and destroys them. In this way, CAR T-cells eliminate cancer from the patient's body, leading to a cancer-free life," he said. Head of clinical haematology department Dr Akshay Lahoti highlighted that similar CAR T-cell therapy treatments abroad can cost up to Rs 4 crore. He extended gratitude for the extensive support received from various individuals and organisations, including Dr Rahul Bhargava (head haematologist, Fortis Hospital), Dr Sudhir Kataria, Dr Preeti Malpani, Dr Prachi Chaudhary, Dr Ashok Yadav, Dr Sumit Shukla, and others.
New Indian Express
7 days ago
- Health
- New Indian Express
Experts warn of rising blood cancer cases among children, cite pollution and chemicals as key causes
BHUBANESWAR: The incidence of blood cancer or leukaemia in the country is on the upward spiral with a high number of children getting afflicted by the disease, experts said. Addressing an event organised at IMS and SUM Hospital here to mark the World Blood Cancer Day on Wednesday, head of the Hematology department, Hemato Oncology, Bone Marrow Transplant Prof Priyanka Samal said pollution, radiation and use of chemical fertiliser are among the prime causes of blood cancer. 'Though new cases of leukemia are being detected among the young children in the age group of one to 10 years, around 80 to 90 pc of the children are able to defeat the disease with proper treatment and care,' she added. The symptoms of the disease which include continued fever, fall in haemoglobin, total leukocyte count and platelet level, appearance of black spots on the body and bleeding, should not be ignored. 'Once diagnosed, it can be cured depending on the stage. We have the latest treatment regimen like bone marrow transplantation, haplo transplant and Chimeric Antigen Receptor- T (CAR-T) Cell Therapy, which have been very successful,' Dr Samal added. Eminent neurosurgeon and SOA's principal advisor (health sciences) Prof Ashok Kumar Mahapatra, dean Prof Sanghamitra Mishra, medical superintendent (MS) Prof Pusparaj Samantasinghar and MS of SUM's Phulnakhara campus Prof Rajesh Lenka spoke.
Yahoo
08-05-2025
- Business
- Yahoo
Cellipont Bioservices and Optieum Biotechnologies Partner to Advance cGMP Manufacturing of Groundbreaking CAR-T Therapy for Glioblastoma
Collaboration Leverages the OPTF01 product to Drive Next-Generation CAR-T Development THE WOODLANDS, Texas and EHIME, Japan, May 8, 2025 /PRNewswire/ -- Cellipont Bioservices, a leading cell therapy Contract Development and Manufacturing Organization (CDMO), and Optieum Biotechnologies (Optieum), a preclinical stage company dedicated to the discovery and development of innovative Chimeric Antigen Receptor (CAR) T cell therapies, today announced a partnership for cGMP manufacturing of OPTF01, Optieum's novel CAR-T therapy for glioblastoma treatment, a product derived from their proprietary Eumbody System. OPTF01 specifically targets Fibroblast activation protein-alpha (FAPα) a protein expressed on both tumor cells and the surrounding pericytes and Cancer-associated Fibroblasts (CAFs). Hence, OPTF01 can potentially disrupt the immunosuppressive microenvironment around the tumor while simultaneously attacking the malignant cells within the tumor. Successful development of this therapeutic approach would address a critical unmet medical need for patients with refractory glioblastoma who currently face limited treatment options with poor prognoses, as well as various other solid tumor indications. Under this collaboration, Cellipont Bioservices will provide the technology transfer, process development, and cGMP manufacturing of Optieum's novel OPTF01 CAR-T product. "Glioblastoma remains one of the most aggressive and difficult-to-treat cancers, demanding urgent innovation beyond traditional approaches," said Darren Head, CEO of Cellipont Bioservices. "Our collaboration with Optieum presents an exciting opportunity to leverage advanced CAR-T technologies and bring meaningful solutions to patients in need. We are honored to be part of this critical mission." Shun Nishioka, CEO of Optieum added, "At Optieum, we are committed to redefining the future of CAR-T therapy through relentless innovation and scientific rigor. Partnering with Cellipont's team of experts ensures that our groundbreaking therapies are manufactured to the highest standards, accelerating our progress toward delivering next-generation therapies for glioblastoma and other solid tumors." OPTF01 is derived from the Eumbody System, a proprietary platform representing a significant advancement in CAR-T cell therapy development. This platform leverages rapid and expansive functional screening to identify and optimize CAR constructs in unprecedented fashion. By dynamically harmonizing single-chain variable fragment (scFv) sequences to enhance the functional capabilities of T cells, the Eumbody System sets a new standard in CAR-T innovation. About CellipontCellipont Bioservices is a premier Contract Development and Manufacturing Organization (CDMO) specializing in the advancement of cell therapies. With a team of industry-leading experts, Cellipont is at the forefront of cell therapy development and manufacturing, offering comprehensive solutions from process development, analytical services, to large-scale commercial manufacturing. Our purpose-built facility, combined with our cutting-edge technology and commitment to quality enable us to support our clients in delivering life-changing cell therapies to patients worldwide. Cellipont Bioservices is dedicated to excellence in all aspects of our operations, ensuring that we not only meet but exceed the expectations of our clients and the communities we serve. To learn more, visit and follow us on LinkedIn. About Optieum BiotechnologiesOptieum Biotechnologies Inc. is a cutting-edge biotechnology company dedicated to engineering hope for patients through the development of next-generation CAR-T cell therapies. At the heart of Optieum's innovation is its proprietary Eumbody System, a revolutionary platform that optimizes CAR constructs to unlock the full therapeutic potential of T cells by dynamically harmonizing CAR binding domains. This transformative platform has the potential to redefine CAR-T cell therapy, enabling the development of groundbreaking treatments for challenging diseases. For more information, visit and follow us on LinkedIn. View original content to download multimedia: SOURCE Cellipont Bioservices Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Khaleej Times
15-04-2025
- Health
- Khaleej Times
UAE to locally produce CAR-T cancer therapy at 90% less cost
The treatment cost of some of the most aggressive forms of cancers like leukemia and lymphoma could now significantly come down in the UAE. In an effort to revolutionise cancer care across the Mena region, Burjeel Holdings has joined forces with US-based non-profit Caring Cross to locally manufacture CAR-T (Chimeric Antigen Receptor T-cell therapy) cell therapies in the country — at up to 90 per cent less than current international costs. This was revealed on the opening day of Abu Dhabi Health Week, which kicked off on Tuesday. It (CAR-T) is a cutting-edge form of immunotherapy used primarily to treat certain types of cancer, especially blood cancers. How does CAR-T cell therapy work? T-cells are collected from the patient's blood. In a lab, these T-cells are genetically modified to express a special receptor (CAR) that targets cancer cells. The modified CAR-T cells are grown and multiplied in the lab. They are infused back into the patient, where they seek out and destroy cancer cells. The partnership aims to establish a comprehensive ecosystem for the production of CAR-T therapies. Caring Cross will provide the technology, raw materials, and expert training needed to support this local infrastructure. CAR-T therapies, which genetically reprogram a patient's immune cells to target and destroy cancer cells, have demonstrated significant success in treating aggressive blood cancers such as leukemia and lymphoma. The move is expected to dramatically improve access and affordability of advanced cancer treatments across the region. Enhancing access to life-saving cancer care The collaboration will position the UAE as a regional hub for advanced cell and gene therapies. By enabling local, point-of-care production of patient-specific therapies, the initiative will expand the reach of these therapies to underserved populations across the Mena region. The first phase of the program will focus on CAR-T therapies for leukemia and lymphoma, with plans to explore treatments for other diseases, including HIV, in the future. Dr Ajlan Al Zaki, Director of the Hematology Oncology & Cellular Therapy Center at Burjeel Hospital Abu Dhabi said, 'We are honored to partner with Caring Cross, whose expertise in CAR-T cell therapy production technology will enable us to provide affordable, life-saving treatments to our communities and beyond. This partnership is a pivotal step in our commitment to advancing medical innovation and expanding access to critical healthcare services.' The partnership will focus on training and developing local healthcare providers, ensuring the sustainable and scalable delivery of CAR-T therapies across Mena, India, and globally. Notably, with costs ranging from US$350,000 to over $1 million in global markets, access for blood cancer treatments remain severely restricted. Stakeholders emphasized that the partnership seeks to dismantle this barrier by enabling the production of CAR-T therapies at a fraction of the current price, making these treatments accessible to a vastly broader patient population in Mena and beyond. 'We are excited to partner with Burjeel Holdings to improve access to CAR-T cell and other ATMPs for patients across their hospital networks in the Mena region,' said Boro Dropulić, Executive Director of Caring Cross. 'This collaboration advances our mission to make these groundbreaking treatments accessible and affordable around the world. We intend to significantly improve patient access with a sustainable and cost-effective model.'
Yahoo
14-02-2025
- Business
- Yahoo
Citius Pharmaceuticals, Inc. Reports Fiscal First Quarter 2025 Financial Results and Provides Business Update
CRANFORD, N.J., Feb. 14, 2025 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius Pharma" or the "Company") (Nasdaq: CTXR), a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products today reported business and financial results for the fiscal first quarter ended December 31, 2024. Fiscal First Quarter 2025 Business Highlights and Subsequent Developments Substantially advanced operational readiness for commercial launch of LYMPHIR in the first half of 2025; Secured a new permanent J-code, J9161, (Injection, denileukin diftitox-cxdl, for intravenous use, 1 microgram) for LYMPHIR™, assigned by the Centers for Medicare & Medicaid Services (CMS), with an expected effective date of April 1, 2025; Announced promising preliminary results from an ongoing investigator-initiated Phase I clinical trial of a combined regimen of checkpoint inhibitor pembrolizumab and LYMPHIR (denileukin diftitox-cxdl) in patients with recurrent solid tumors. Presented data at the Society for Immunotherapy of Cancer (SITC) 2024 Annual Meeting; Supported expansion of the University of Minnesota's investigator-initiated Phase I clinical trial to evaluate the safety and efficacy of denileukin diftitox administration prior to Chimeric Antigen Receptor (CAR-T) therapies for the treatment of B-cell lymphomas with the dosing of the first patient at City of Hope cancer center; Engaged with the U.S. Food and Drug Administration (FDA) to clarify development paths for pipeline assets Mino-Lok® and Halo-Lido; Advanced strategic and financing initiatives to help secure the capital needed to drive the full potential of our clinical and commercial programs. Citius Oncology (Nasdaq: CTOR), our majority-owned subsidiary, engaged Jefferies as exclusive financial advisor to assist in evaluating strategic alternatives aimed at maximizing shareholder value; Completed registered direct offerings of common stock and warrants in November 2024 and January 2025, and sold shares of common stock through the Company's "at-the-market" facility in January 2025 for combined gross proceeds of $6.5 million; Effective November 25, 2024, the Company executed a reverse stock split of its common stock, at a ratio of 1-for-25; and, On December 18, 2024, the Company received notification that it had regained compliance with the $1.00 per share requirement for continued inclusion on the Nasdaq Stock Market. Financial Highlights Cash and cash equivalents of $1.1 million as of December 31, 2024; R&D expenses were $2.1 million for the first quarter ended December 31, 2024, compared to $2.6 million for the first quarter ended December 31, 2023; G&A expenses were $5.4 million for the first quarter ended December 31, 2024, compared to $3.7 million for the first quarter ended December 31, 2023; Stock-based compensation expense was $2.5 million for the first quarter ended December 31, 2024, compared to $3.1 million for the first quarter ended December 31, 2023; and, Net loss was $10.3 million, or ($1.30) per share for the first quarter ended December 31, 2024, compared to a net loss of $9.2 million, or ($1.45) per share for the first quarter ended December 31, 2023. "As we continue to advance our strategic priorities, we remain engaged in active discussions with potential partners who recognize the value of our pipeline and our commitment to developing innovative therapies for patients with high unmet medical needs. Securing the necessary financing to support our key programs remains a top priority, and we are evaluating multiple options to strengthen our financial position," stated Leonard Mazur, Chairman and CEO of Citius Pharmaceuticals. "In parallel, we are making significant progress in our preparations for the anticipated launch of LYMPHIR™ in the first half of 2025, positioning us to bring this important therapy to patients while creating long-term value for our shareholders. We look forward to providing further updates as we execute on these critical initiatives," added Mazur. FISCAL FIRST QUARTER 2025 FINANCIAL RESULTS: Liquidity As of December 31, 2024, the Company had $1.1 million in cash and cash equivalents. As of December 31, 2024, the Company had 7,727,243 common shares outstanding, as adjusted for the 1-for-25 reverse stock split of the Company's common stock, effected on November 25, 2024. During the quarter ended December 31, 2024, the Company received gross proceeds of $3 million from the issuance of equity. An additional $3.5 million in gross proceeds was received in January 2025 from the issuance of equity through the Company's "at-the-market" facility and a registered direct offering of common stock and warrants. The Company expects to raise additional capital to support operations. Research and Development (R&D) Expenses R&D expenses were $2.1 million for the first quarter ended December 31, 2024, compared to $2.6 million for the first quarter ended December 31, 2023. The decrease in R&D expenses primarily reflects the completion of the Halo-Lido Phase 2 and Mino-Lok Phase 3 trials, offset by an increase in LYMPHIR-related expenses due to additional headcount and ongoing investigator-initiated trials. We expect that research and development expenses will continue to decrease in fiscal 2025 because we have completed the Phase 3 trial for Mino-Lok and we remain focused on the commercialization of LYMPHIR through our majority-owned subsidiary, Citius Oncology, Inc. General and Administrative (G&A) Expenses G&A expenses were $5.4 million for the first quarter ended December 31, 2024, compared to $3.7 million for the first quarter ended December 31, 2023. The increase was primarily due to higher costs for pre-launch sales and marketing activities associated with LYMPHIR. General and administrative expenses consist primarily of compensation costs, professional fees for legal, regulatory, accounting, and corporate development services, and investor relations expenses. Stock-based Compensation Expense For the first quarter ended December 31, 2024, stock-based compensation expense was $2.5 million as compared to $3.1 million for the prior year. Stock-based compensation expense during the quarter ended December 31, 2024 is primarily related to the Citius Oncology Plan. The decrease compared to the prior year is due to lower costs associated with the Citius Pharma stock plans. Net loss Net loss was $10.3 million, or ($1.30) per share for the quarter ended December 31, 2024, compared to a net loss of $9.2 million, or ($1.45) per share for the quarter ended December 31, 2023, as adjusted for the reverse stock split. The increase in net loss was due to the increase in general and administrative expenses partially offset by lower research and development expense. About Citius Pharmaceuticals, Inc. Citius Pharma is a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products. In August 2024, the FDA approved LYMPHIR™, a targeted immunotherapy for an initial indication in the treatment of cutaneous T-cell lymphoma. Citius Pharma's late-stage pipeline also includes Mino-Lok®, an antibiotic lock solution to salvage catheters in patients with catheter-related bloodstream infections, and CITI-002 (Halo-Lido), a topical formulation for the relief of hemorrhoids. A Pivotal Phase 3 Trial for Mino-Lok and a Phase 2b trial for Halo-Lido were completed in 2023. Mino-Lok met primary and secondary endpoints of its Phase 3 Trial. Citius Pharma is actively engaged with the FDA to outline next steps for both programs. For more information, please visit Forward-Looking Statements This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting Citius Pharma. You can identify these statements by the fact that they use words such as "will," "anticipate," "estimate," "expect," "plan," "should," and "may" and other words and terms of similar meaning or use of future dates. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated, and, unless noted otherwise, that apply to Citius Pharma are: our need for substantial additional funds and our ability to raise additional money to fund our operations for at least the next 12 months as a going concern; our ability to commercialize LYMPHIR through our majority-owned subsidiary and any of our other product candidates that may be approved by the FDA; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; the estimated markets for our product candidates and the acceptance thereof by any market; the ability of our product candidates to impact the quality of life of our target patient populations; risks related to research using our assets but conducted by third parties; risks relating to the results of research and development activities, including those from our existing and any new pipeline assets; our ability to maintain compliance with Nasdaq's continued listing standards; our dependence on third-party suppliers; our ability to procure cGMP commercial-scale supply; uncertainties relating to preclinical and clinical testing; the early stage of products under development; market and other conditions; risks related to our growth strategy; patent and intellectual property matters; our ability to identify, acquire, close and integrate product candidates and companies successfully and on a timely basis; government regulation; competition; as well as other risks described in our Securities and Exchange Commission ("SEC") filings. These risks have been and may be further impacted by any future public health risks. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our SEC filings which are available on the SEC's website at including in Citius Pharma's Annual Report on Form 10-K for the year ended September 30, 2024, filed with the SEC on December 27, 2024, as amended on January 27, 2025 and as updated by our subsequent filings with the SEC. These forward-looking statements speak only as of the date hereof, and we expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law. Investor Contact: Ilanit Allenir@ 908-967-6677 x113 Media Contact: STiR-communicationsGreg SalsburgGreg@ -- Financial Tables Follow – CITIUS PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS(Unaudited)December 31, September 30, 2024 2024 ASSETSCurrent Assets:Cash and cash equivalents$ 1,100,079 $ 3,251,880 Inventory 14,381,3698,268,766 Prepaid expenses 2,845,7392,700,000 Total Current Assets 18,327,18714,220,646 Operating lease right-of-use asset, net 191,412246,247 Deposits 38,06238,062 In-process research and development 92,800,00092,800,000 Goodwill 9,346,7969,346,796 Total Other Assets 102,184,858102,184,858 Total Assets$ 120,703,457 $ 116,651,751 LIABILITIES AND STOCKHOLDERS' EQUITYCurrent Liabilities:Accounts payable$ 7,364,120 $ 4,927,211 License payable 28,400,00028,400,000 Accrued expenses 6,242,17817,027 Accrued compensation 2,595,0912,229,018 Operating lease liability 204,569241,547 Total Current Liabilities 44,805,95835,814,803 Deferred tax liability 6,978,0406,713,800 Operating lease liability - noncurrent -21,318 Total Liabilities 51,783,99842,549,921 Commitments and ContingenciesStockholders' Equity:Preferred stock - $0.001 par value; 10,000,000 shares authorized; no shares issued and outstanding -- Common stock - $0.001 par value; 16,000,000 shares authorized; 7,727,243 and 7,247,243 shares issued and outstanding at December 31, 2024 and September 30, 2024, respectively 7,7277,247 Additional paid-in capital 276,538,816271,440,421 Accumulated deficit (211,138,464)(201,370,218) Total Citius Pharmaceuticals, Inc. Stockholders' Equity 65,408,07970,077,450 Non-controlling interest 3,511,3804,024,380 Total Equity 68,919,45974,101,830 Total Liabilities and Equity$ 120,703,457 $ 116,651,751Reflects a 1-for-25 reverse stock split effective November 25, 2024. CITIUS PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS FOR THE THREE MONTHS ENDED DECEMBER 31, 2024 AND 2023 (Unaudited)Three Months Ended December 31, December 31, 2024 2023 Revenues$ - $ - Operating ExpensesResearch and development 2,127,0382,621,910 General and administrative 5,387,7523,660,728 Stock-based compensation - general and administrative 2,524,8243,058,185 Total Operating Expenses 10,039,6149,340,823 Operating Loss (10,039,614)(9,340,823) Other IncomeInterest income 22,608253,638 Total Other Income 22,608253,638 Loss before Income Taxes (10,017,006)(9,087,185) Income tax expense 264,240144,000 Net Loss (10,281,246)(9,231,185) Net loss attributable to non-controlling interest 513,000- Net Loss Applicable to Common Stockholders$ (9,768,246) $ (9,231,185) Net Loss Per Share - Basic and Diluted$ (1.30) $ (1.45) Weighted Average Common Shares OutstandingBasic and diluted 7,492,4606,358,237Reflects a 1-for-25 reverse stock split effective November 25, 2024. CITIUS PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS FOR THE THREE MONTHS ENDED DECEMBER 31, 2024 AND 2023 (Unaudited)2024 2023 Cash Flows From Operating Activities:Net loss$ (10,281,246) $ (9,231,185) Adjustments to reconcile net loss to net cash used in operating activities:Stock-based compensation expense 2,524,8243,058,185 Issuance of common stock for services -76,146 Amortization of operating lease right-of-use asset 54,83550,430 Depreciation -578 Deferred income tax expense 264,240144,000 Changes in operating assets and liabilities:Inventory (6,112,603)- Prepaid expenses (145,739)25,010 Accounts payable 2,436,909(280,083) Accrued expenses 6,225,151(199,403) Accrued compensation 366,073273,688 Operating lease liability (58,296)(52,676) Net Cash Used In Operating Activities (4,725,852)(6,135,310) Cash Flows From Financing Activities:Net proceeds from registered direct offering 2,574,051- Net Cash Provided By Financing Activities 2,574,051- Net Change in Cash and Cash Equivalents (2,151,801)(6,135,310) Cash and Cash Equivalents - Beginning of Period 3,251,88026,480,928 Cash and Cash Equivalents - End of Period$ 1,100,079 $ 20,345,618 View original content to download multimedia: SOURCE Citius Pharmaceuticals, Inc. 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