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News Article | May 15, 2017
Site: globenewswire.com

BASKING RIDGE, N.J., May 15, 2017 (GLOBE NEWSWIRE) -- Caladrius Biosciences, Inc. (NASDAQ:CLBS) (“Caladrius” or the “Company”), a cell therapy company with a therapeutic development pipeline focused on immune modulation and select cardiovascular conditions as well as a subsidiary, PCT, a development and manufacturing partner for the cell therapy industry, announces financial results for the three months ended March 31, 2017. Highlights of the 2017 first quarter and recent weeks “We look forward to the successful acquisition by Hitachi of our remaining interest in PCT.  Their ability to deploy the capital and engineering capabilities needed to achieve PCT’s commercial scale manufacturing growth goals and establish a global commercial manufacturing enterprise will benefit all of PCT’s clients, especially Caladrius, as PCT will continue to provide development and manufacturing services for our T-regulatory cell programs,” stated David J. Mazzo, PhD, President and Chief Executive Officer of Caladrius. “Following this transaction, Caladrius will emerge as a pure-play, well capitalized development company with the funding needed to complete our Phase 2 clinical program and to selectively and opportunistically invest in other pipeline programs through a disciplined, data-driven process.  We also remain committed to continuing to explore other means of collaborative support, such as grants, partnerships or licensing, to contribute to any development programs we undertake. “We continue to be excited about the opportunities for our lead program, CLBS03 and the Phase 2 T-Rex underway for the treatment of type 1 diabetes.  We look forward to reaching the half-way treatment mark in mid-year.  Also, in conjunction with our September 2016 private placement, enrollment of the 70th subject will trigger an additional infusion of capital, which we also expect to occur in the coming months,” concluded Dr. Mazzo. Total revenues for the first quarter of 2017 increased 6% to $7.9 million compared with $7.5 million in the first quarter of 2016, primarily due to higher reported Clinical Services revenues at PCT. However, first quarter of 2017 gross margin was negative 2% due to significant unused capacity at PCT resulting from lower patient enrollment in client clinical trials, together with the conclusion of a contract with a single large client. This compares to gross margin of $1.3 million, or 17%, for the first quarter of 2016. Research and development (R&D) expenses for the first quarter of 2017 decreased 41% to $3.5 million compared with $5.9 million for the first quarter of 2016, primarily related to the discontinuation of non-core R&D programs announced at the beginning of 2016 and related reductions in R&D staffing and departmental costs, partially offset by increased costs related to the ongoing Phase 2 T-Rex Study. Selling, general and administrative (SG&A) expenses were approximately $5.9 million for the first quarter of 2017 compared with $6.5 million for the same period in 2016, primarily due to lower operational and compensation-related costs during the 2017 first quarter, offset by $1.3 million in transaction related expenses in connection with the Hitachi Chemical acquisition of the Company’s PCT subsidiary. The net loss attributable to Caladrius common stockholders for the three months ended March 31, 2017 was $9.4 million or $1.12 per share, compared with $12.0 million or $2.09 per share for same period in 2016. As of March 31, 2017, Caladrius had cash and cash equivalents of $12.0 million compared with $14.7 million as of December 31, 2016. During the first quarter the Company received $5.0 million in connection with the signing of the Hitachi transaction and $2.0 million paid from Sanford Research with the delivery to them of the second tranche of securities pursuant to their equity investment in Caladrius in September, 2016.  We also began making principal payments on our long-term debt with Oxford Finance. Net cash used in operating activities during the first quarter of 2017 of $10.1 million was unusually high primarily due to lower gross margins in the PCT business compared to prior quarters, and Hitachi transaction-related costs. The Company expects to provide more specifics on cash usage for the balance of 2017 after the closing of the Hitachi transaction. Caladrius’ management will host a conference call for the investment community on May 18, 2017, beginning at 5:00 p.m. Eastern Time to review the financial results, provide a Company update and answer questions. Shareholders and other interested parties may participate in the conference call by dialing 877-562-4460 (U.S.) or 513-438-4106 (international) and providing conference ID 20837689. The call will also be broadcast live on the Internet via the Company’s website at www.caladrius.com/events. The webcast will be archived on the Company’s website for 90 days. About Caladrius Biosciences Caladrius Biosciences, Inc. is a cell therapy development company with cell therapy products in development based on multiple technology platforms and targeting autoimmune and cardiology indications. The Company is investigating its lead product candidate, CLBS03, for the treatment of recent-onset type 1 diabetes in a currently enrolling Phase 2 trial. The Company’s subsidiary, PCT, is a well-known development and manufacturing partner exclusively focused on the cell therapy industry and has served over 100 clients since 1999. For more information on Caladrius please visit www.caladrius.com. This Press Release contains forward-looking statements within the meaning of Private Securities Litigation Reform Act of 1995, including forward-looking statements regarding the Sale, the possibility of obtaining stockholder or other approvals or consents for the Sale and Caladrius’ future prospects. These statements are neither promises nor guarantees, but involve risks and uncertainties that could cause actual events or results to differ materially from those set forth in the forward-looking statements, including, without limitation: risks and uncertainties relating to potential adverse reactions or changes to business relationships resulting from the announcement or completion of the Sale; risks related to the failure to complete the Sale; unexpected costs, charges or expenses relating to or resulting from the Sale; restrictions contained in, and termination fees that may be payable pursuant to, the purchase agreement relating to the Sale; litigation or adverse judgments relating to the Sale; risks relating to the completion of the proposed Sale, including the risk that the required stockholder vote might not be obtained in a timely manner or at all, or other conditions to the completion of the Sale not being satisfied; any difficulties associated with requests or directions from governmental authorities resulting from their review of the Sale; any changes in general economic and/or industry-specific conditions; and other risks detailed in Caladrius’ filings with the SEC, including those disclosed under “Item 1A. Risk Factors” in Caladrius’ Annual Report on Form 10-K filed with the SEC on March 17, 2017 and in subsequent reports on Forms 10-Q and 8-K and other filings made with the SEC. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date of this Press Release. Caladrius does not intend, and disclaims any obligation, to update or revise any forward-looking information contained in this Press Release or with respect to the matters described herein.


News Article | May 15, 2017
Site: globenewswire.com

BASKING RIDGE, N.J., May 15, 2017 (GLOBE NEWSWIRE) -- Caladrius Biosciences, Inc. (NASDAQ:CLBS) (“Caladrius” or the “Company”), a cell therapy company with a therapeutic development pipeline focused on immune modulation and select cardiovascular conditions as well as a subsidiary, PCT, a development and manufacturing partner for the cell therapy industry, announces financial results for the three months ended March 31, 2017. Highlights of the 2017 first quarter and recent weeks “We look forward to the successful acquisition by Hitachi of our remaining interest in PCT.  Their ability to deploy the capital and engineering capabilities needed to achieve PCT’s commercial scale manufacturing growth goals and establish a global commercial manufacturing enterprise will benefit all of PCT’s clients, especially Caladrius, as PCT will continue to provide development and manufacturing services for our T-regulatory cell programs,” stated David J. Mazzo, PhD, President and Chief Executive Officer of Caladrius. “Following this transaction, Caladrius will emerge as a pure-play, well capitalized development company with the funding needed to complete our Phase 2 clinical program and to selectively and opportunistically invest in other pipeline programs through a disciplined, data-driven process.  We also remain committed to continuing to explore other means of collaborative support, such as grants, partnerships or licensing, to contribute to any development programs we undertake. “We continue to be excited about the opportunities for our lead program, CLBS03 and the Phase 2 T-Rex underway for the treatment of type 1 diabetes.  We look forward to reaching the half-way treatment mark in mid-year.  Also, in conjunction with our September 2016 private placement, enrollment of the 70th subject will trigger an additional infusion of capital, which we also expect to occur in the coming months,” concluded Dr. Mazzo. Total revenues for the first quarter of 2017 increased 6% to $7.9 million compared with $7.5 million in the first quarter of 2016, primarily due to higher reported Clinical Services revenues at PCT. However, first quarter of 2017 gross margin was negative 2% due to significant unused capacity at PCT resulting from lower patient enrollment in client clinical trials, together with the conclusion of a contract with a single large client. This compares to gross margin of $1.3 million, or 17%, for the first quarter of 2016. Research and development (R&D) expenses for the first quarter of 2017 decreased 41% to $3.5 million compared with $5.9 million for the first quarter of 2016, primarily related to the discontinuation of non-core R&D programs announced at the beginning of 2016 and related reductions in R&D staffing and departmental costs, partially offset by increased costs related to the ongoing Phase 2 T-Rex Study. Selling, general and administrative (SG&A) expenses were approximately $5.9 million for the first quarter of 2017 compared with $6.5 million for the same period in 2016, primarily due to lower operational and compensation-related costs during the 2017 first quarter, offset by $1.3 million in transaction related expenses in connection with the Hitachi Chemical acquisition of the Company’s PCT subsidiary. The net loss attributable to Caladrius common stockholders for the three months ended March 31, 2017 was $9.4 million or $1.12 per share, compared with $12.0 million or $2.09 per share for same period in 2016. As of March 31, 2017, Caladrius had cash and cash equivalents of $12.0 million compared with $14.7 million as of December 31, 2016. During the first quarter the Company received $5.0 million in connection with the signing of the Hitachi transaction and $2.0 million paid from Sanford Research with the delivery to them of the second tranche of securities pursuant to their equity investment in Caladrius in September, 2016.  We also began making principal payments on our long-term debt with Oxford Finance. Net cash used in operating activities during the first quarter of 2017 of $10.1 million was unusually high primarily due to lower gross margins in the PCT business compared to prior quarters, and Hitachi transaction-related costs. The Company expects to provide more specifics on cash usage for the balance of 2017 after the closing of the Hitachi transaction. Caladrius’ management will host a conference call for the investment community on May 18, 2017, beginning at 5:00 p.m. Eastern Time to review the financial results, provide a Company update and answer questions. Shareholders and other interested parties may participate in the conference call by dialing 877-562-4460 (U.S.) or 513-438-4106 (international) and providing conference ID 20837689. The call will also be broadcast live on the Internet via the Company’s website at www.caladrius.com/events. The webcast will be archived on the Company’s website for 90 days. About Caladrius Biosciences Caladrius Biosciences, Inc. is a cell therapy development company with cell therapy products in development based on multiple technology platforms and targeting autoimmune and cardiology indications. The Company is investigating its lead product candidate, CLBS03, for the treatment of recent-onset type 1 diabetes in a currently enrolling Phase 2 trial. The Company’s subsidiary, PCT, is a well-known development and manufacturing partner exclusively focused on the cell therapy industry and has served over 100 clients since 1999. For more information on Caladrius please visit www.caladrius.com. This Press Release contains forward-looking statements within the meaning of Private Securities Litigation Reform Act of 1995, including forward-looking statements regarding the Sale, the possibility of obtaining stockholder or other approvals or consents for the Sale and Caladrius’ future prospects. These statements are neither promises nor guarantees, but involve risks and uncertainties that could cause actual events or results to differ materially from those set forth in the forward-looking statements, including, without limitation: risks and uncertainties relating to potential adverse reactions or changes to business relationships resulting from the announcement or completion of the Sale; risks related to the failure to complete the Sale; unexpected costs, charges or expenses relating to or resulting from the Sale; restrictions contained in, and termination fees that may be payable pursuant to, the purchase agreement relating to the Sale; litigation or adverse judgments relating to the Sale; risks relating to the completion of the proposed Sale, including the risk that the required stockholder vote might not be obtained in a timely manner or at all, or other conditions to the completion of the Sale not being satisfied; any difficulties associated with requests or directions from governmental authorities resulting from their review of the Sale; any changes in general economic and/or industry-specific conditions; and other risks detailed in Caladrius’ filings with the SEC, including those disclosed under “Item 1A. Risk Factors” in Caladrius’ Annual Report on Form 10-K filed with the SEC on March 17, 2017 and in subsequent reports on Forms 10-Q and 8-K and other filings made with the SEC. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date of this Press Release. Caladrius does not intend, and disclaims any obligation, to update or revise any forward-looking information contained in this Press Release or with respect to the matters described herein.


News Article | May 15, 2017
Site: globenewswire.com

BASKING RIDGE, N.J., May 15, 2017 (GLOBE NEWSWIRE) -- Caladrius Biosciences, Inc. (NASDAQ:CLBS) (“Caladrius” or the “Company”), a cell therapy company with a therapeutic development pipeline focused on immune modulation and select cardiovascular conditions as well as a subsidiary, PCT, a development and manufacturing partner for the cell therapy industry, announces financial results for the three months ended March 31, 2017. Highlights of the 2017 first quarter and recent weeks “We look forward to the successful acquisition by Hitachi of our remaining interest in PCT.  Their ability to deploy the capital and engineering capabilities needed to achieve PCT’s commercial scale manufacturing growth goals and establish a global commercial manufacturing enterprise will benefit all of PCT’s clients, especially Caladrius, as PCT will continue to provide development and manufacturing services for our T-regulatory cell programs,” stated David J. Mazzo, PhD, President and Chief Executive Officer of Caladrius. “Following this transaction, Caladrius will emerge as a pure-play, well capitalized development company with the funding needed to complete our Phase 2 clinical program and to selectively and opportunistically invest in other pipeline programs through a disciplined, data-driven process.  We also remain committed to continuing to explore other means of collaborative support, such as grants, partnerships or licensing, to contribute to any development programs we undertake. “We continue to be excited about the opportunities for our lead program, CLBS03 and the Phase 2 T-Rex underway for the treatment of type 1 diabetes.  We look forward to reaching the half-way treatment mark in mid-year.  Also, in conjunction with our September 2016 private placement, enrollment of the 70th subject will trigger an additional infusion of capital, which we also expect to occur in the coming months,” concluded Dr. Mazzo. Total revenues for the first quarter of 2017 increased 6% to $7.9 million compared with $7.5 million in the first quarter of 2016, primarily due to higher reported Clinical Services revenues at PCT. However, first quarter of 2017 gross margin was negative 2% due to significant unused capacity at PCT resulting from lower patient enrollment in client clinical trials, together with the conclusion of a contract with a single large client. This compares to gross margin of $1.3 million, or 17%, for the first quarter of 2016. Research and development (R&D) expenses for the first quarter of 2017 decreased 41% to $3.5 million compared with $5.9 million for the first quarter of 2016, primarily related to the discontinuation of non-core R&D programs announced at the beginning of 2016 and related reductions in R&D staffing and departmental costs, partially offset by increased costs related to the ongoing Phase 2 T-Rex Study. Selling, general and administrative (SG&A) expenses were approximately $5.9 million for the first quarter of 2017 compared with $6.5 million for the same period in 2016, primarily due to lower operational and compensation-related costs during the 2017 first quarter, offset by $1.3 million in transaction related expenses in connection with the Hitachi Chemical acquisition of the Company’s PCT subsidiary. The net loss attributable to Caladrius common stockholders for the three months ended March 31, 2017 was $9.4 million or $1.12 per share, compared with $12.0 million or $2.09 per share for same period in 2016. As of March 31, 2017, Caladrius had cash and cash equivalents of $12.0 million compared with $14.7 million as of December 31, 2016. During the first quarter the Company received $5.0 million in connection with the signing of the Hitachi transaction and $2.0 million paid from Sanford Research with the delivery to them of the second tranche of securities pursuant to their equity investment in Caladrius in September, 2016.  We also began making principal payments on our long-term debt with Oxford Finance. Net cash used in operating activities during the first quarter of 2017 of $10.1 million was unusually high primarily due to lower gross margins in the PCT business compared to prior quarters, and Hitachi transaction-related costs. The Company expects to provide more specifics on cash usage for the balance of 2017 after the closing of the Hitachi transaction. Caladrius’ management will host a conference call for the investment community on May 18, 2017, beginning at 5:00 p.m. Eastern Time to review the financial results, provide a Company update and answer questions. Shareholders and other interested parties may participate in the conference call by dialing 877-562-4460 (U.S.) or 513-438-4106 (international) and providing conference ID 20837689. The call will also be broadcast live on the Internet via the Company’s website at www.caladrius.com/events. The webcast will be archived on the Company’s website for 90 days. About Caladrius Biosciences Caladrius Biosciences, Inc. is a cell therapy development company with cell therapy products in development based on multiple technology platforms and targeting autoimmune and cardiology indications. The Company is investigating its lead product candidate, CLBS03, for the treatment of recent-onset type 1 diabetes in a currently enrolling Phase 2 trial. The Company’s subsidiary, PCT, is a well-known development and manufacturing partner exclusively focused on the cell therapy industry and has served over 100 clients since 1999. For more information on Caladrius please visit www.caladrius.com. This Press Release contains forward-looking statements within the meaning of Private Securities Litigation Reform Act of 1995, including forward-looking statements regarding the Sale, the possibility of obtaining stockholder or other approvals or consents for the Sale and Caladrius’ future prospects. These statements are neither promises nor guarantees, but involve risks and uncertainties that could cause actual events or results to differ materially from those set forth in the forward-looking statements, including, without limitation: risks and uncertainties relating to potential adverse reactions or changes to business relationships resulting from the announcement or completion of the Sale; risks related to the failure to complete the Sale; unexpected costs, charges or expenses relating to or resulting from the Sale; restrictions contained in, and termination fees that may be payable pursuant to, the purchase agreement relating to the Sale; litigation or adverse judgments relating to the Sale; risks relating to the completion of the proposed Sale, including the risk that the required stockholder vote might not be obtained in a timely manner or at all, or other conditions to the completion of the Sale not being satisfied; any difficulties associated with requests or directions from governmental authorities resulting from their review of the Sale; any changes in general economic and/or industry-specific conditions; and other risks detailed in Caladrius’ filings with the SEC, including those disclosed under “Item 1A. Risk Factors” in Caladrius’ Annual Report on Form 10-K filed with the SEC on March 17, 2017 and in subsequent reports on Forms 10-Q and 8-K and other filings made with the SEC. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date of this Press Release. Caladrius does not intend, and disclaims any obligation, to update or revise any forward-looking information contained in this Press Release or with respect to the matters described herein.


News Article | May 15, 2017
Site: globenewswire.com

BASKING RIDGE, N.J., May 15, 2017 (GLOBE NEWSWIRE) -- Caladrius Biosciences, Inc. (NASDAQ:CLBS) (“Caladrius” or the “Company”), a cell therapy company with a therapeutic development pipeline focused on immune modulation and select cardiovascular conditions as well as a subsidiary, PCT, a development and manufacturing partner for the cell therapy industry, announces financial results for the three months ended March 31, 2017. Highlights of the 2017 first quarter and recent weeks “We look forward to the successful acquisition by Hitachi of our remaining interest in PCT.  Their ability to deploy the capital and engineering capabilities needed to achieve PCT’s commercial scale manufacturing growth goals and establish a global commercial manufacturing enterprise will benefit all of PCT’s clients, especially Caladrius, as PCT will continue to provide development and manufacturing services for our T-regulatory cell programs,” stated David J. Mazzo, PhD, President and Chief Executive Officer of Caladrius. “Following this transaction, Caladrius will emerge as a pure-play, well capitalized development company with the funding needed to complete our Phase 2 clinical program and to selectively and opportunistically invest in other pipeline programs through a disciplined, data-driven process.  We also remain committed to continuing to explore other means of collaborative support, such as grants, partnerships or licensing, to contribute to any development programs we undertake. “We continue to be excited about the opportunities for our lead program, CLBS03 and the Phase 2 T-Rex underway for the treatment of type 1 diabetes.  We look forward to reaching the half-way treatment mark in mid-year.  Also, in conjunction with our September 2016 private placement, enrollment of the 70th subject will trigger an additional infusion of capital, which we also expect to occur in the coming months,” concluded Dr. Mazzo. Total revenues for the first quarter of 2017 increased 6% to $7.9 million compared with $7.5 million in the first quarter of 2016, primarily due to higher reported Clinical Services revenues at PCT. However, first quarter of 2017 gross margin was negative 2% due to significant unused capacity at PCT resulting from lower patient enrollment in client clinical trials, together with the conclusion of a contract with a single large client. This compares to gross margin of $1.3 million, or 17%, for the first quarter of 2016. Research and development (R&D) expenses for the first quarter of 2017 decreased 41% to $3.5 million compared with $5.9 million for the first quarter of 2016, primarily related to the discontinuation of non-core R&D programs announced at the beginning of 2016 and related reductions in R&D staffing and departmental costs, partially offset by increased costs related to the ongoing Phase 2 T-Rex Study. Selling, general and administrative (SG&A) expenses were approximately $5.9 million for the first quarter of 2017 compared with $6.5 million for the same period in 2016, primarily due to lower operational and compensation-related costs during the 2017 first quarter, offset by $1.3 million in transaction related expenses in connection with the Hitachi Chemical acquisition of the Company’s PCT subsidiary. The net loss attributable to Caladrius common stockholders for the three months ended March 31, 2017 was $9.4 million or $1.12 per share, compared with $12.0 million or $2.09 per share for same period in 2016. As of March 31, 2017, Caladrius had cash and cash equivalents of $12.0 million compared with $14.7 million as of December 31, 2016. During the first quarter the Company received $5.0 million in connection with the signing of the Hitachi transaction and $2.0 million paid from Sanford Research with the delivery to them of the second tranche of securities pursuant to their equity investment in Caladrius in September, 2016.  We also began making principal payments on our long-term debt with Oxford Finance. Net cash used in operating activities during the first quarter of 2017 of $10.1 million was unusually high primarily due to lower gross margins in the PCT business compared to prior quarters, and Hitachi transaction-related costs. The Company expects to provide more specifics on cash usage for the balance of 2017 after the closing of the Hitachi transaction. Caladrius’ management will host a conference call for the investment community on May 18, 2017, beginning at 5:00 p.m. Eastern Time to review the financial results, provide a Company update and answer questions. Shareholders and other interested parties may participate in the conference call by dialing 877-562-4460 (U.S.) or 513-438-4106 (international) and providing conference ID 20837689. The call will also be broadcast live on the Internet via the Company’s website at www.caladrius.com/events. The webcast will be archived on the Company’s website for 90 days. About Caladrius Biosciences Caladrius Biosciences, Inc. is a cell therapy development company with cell therapy products in development based on multiple technology platforms and targeting autoimmune and cardiology indications. The Company is investigating its lead product candidate, CLBS03, for the treatment of recent-onset type 1 diabetes in a currently enrolling Phase 2 trial. The Company’s subsidiary, PCT, is a well-known development and manufacturing partner exclusively focused on the cell therapy industry and has served over 100 clients since 1999. For more information on Caladrius please visit www.caladrius.com. This Press Release contains forward-looking statements within the meaning of Private Securities Litigation Reform Act of 1995, including forward-looking statements regarding the Sale, the possibility of obtaining stockholder or other approvals or consents for the Sale and Caladrius’ future prospects. These statements are neither promises nor guarantees, but involve risks and uncertainties that could cause actual events or results to differ materially from those set forth in the forward-looking statements, including, without limitation: risks and uncertainties relating to potential adverse reactions or changes to business relationships resulting from the announcement or completion of the Sale; risks related to the failure to complete the Sale; unexpected costs, charges or expenses relating to or resulting from the Sale; restrictions contained in, and termination fees that may be payable pursuant to, the purchase agreement relating to the Sale; litigation or adverse judgments relating to the Sale; risks relating to the completion of the proposed Sale, including the risk that the required stockholder vote might not be obtained in a timely manner or at all, or other conditions to the completion of the Sale not being satisfied; any difficulties associated with requests or directions from governmental authorities resulting from their review of the Sale; any changes in general economic and/or industry-specific conditions; and other risks detailed in Caladrius’ filings with the SEC, including those disclosed under “Item 1A. Risk Factors” in Caladrius’ Annual Report on Form 10-K filed with the SEC on March 17, 2017 and in subsequent reports on Forms 10-Q and 8-K and other filings made with the SEC. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date of this Press Release. Caladrius does not intend, and disclaims any obligation, to update or revise any forward-looking information contained in this Press Release or with respect to the matters described herein.


BASKING RIDGE, N.J., Feb. 23, 2017 (GLOBE NEWSWIRE) -- Caladrius Biosciences, Inc. (NASDAQ:CLBS) (“Caladrius” or the “Company”), a cell therapy company combining a select therapeutic development pipeline with an industry-leading development and manufacturing services provider (PCT), announces today that the California Institute for Regenerative Medicine (CIRM) has awarded a grant to Caladrius, providing up to $12.2 million for the development of CLBS03. CLBS03 is the Company’s investigational cell therapy currently being evaluated as a treatment for recent onset type 1 diabetes (T1D) in a Caladrius-sponsored Phase 2 trial, the Sanford Project: T-Rex Study, in collaboration with Sanford Research, a subsidiary of Sanford Health. The grant from CIRM, which was recommended for approval by its distinguished and independent panel of scientific reviewers, is a significant endorsement of the potential for Caladrius’ novel approach for treating T1D with cell therapy by restoring immune balance. The award has important implications as it is expected to fund a significant portion of the remaining cost of the Company’s Phase 2 trial currently underway. The grant will be used to cover expenses including all manufacturing and development based in California and other trial costs dependent upon the proportion of subjects enrolled in California, with consumption of at least $6 million of the award expected. CLBS03 uses the patient’s own regulatory T cells (Tregs) to treat autoimmune disease. Tregs are a natural part of the human immune system that regulate the activity of T effector cells, which are responsible for protecting the body from viruses and other foreign antigens. When Tregs function properly, only harmful foreign materials are attacked by T effector cells. In autoimmune diseases, it is thought that deficient Treg activity permits the T effector cells to attack the body’s own beneficial cells and, in the case of T1D, insulin-producing pancreatic beta cells, thereby reducing and eventually eliminating the body’s ability to produce sufficient amounts of insulin. Caladrius’ novel approach seeks to restore immune balance by augmenting the number and activity of a patient’s own Tregs and using their innate capabilities to modulate multiple facets of the effector arm of the immune system. CLBS03 has received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration (FDA), and Advanced Therapeutic Medicinal Product classification from the European Medicines Agency. Patients are currently being enrolled in the second cohort of the Phase 2 trial, with an interim analysis of early therapeutic effect expected by the end of 2017. "We are grateful to CIRM and the experts who reviewed and endorsed our application. We firmly believe that this therapy has the potential to improve the lives of people with T1D and this grant helps us advance our Phase 2 clinical study with the goal of determining the potential for CLBS03 to be an effective therapy in this important indication," said David J. Mazzo, PhD, Caladrius’ Chief Executive Officer. "This grant substantiates our approach to identify and secure non-dilutive funding for our development programs and helps position Caladrius as a leader among cell therapy and autoimmune disease therapy developers." About Caladrius Biosciences Caladrius Biosciences, Inc. is a cell therapy development company with cell therapy products in development based on multiple technology platforms and targeting autoimmune and cardiology indications. The company’s subsidiary, PCT, is a leading development and manufacturing partner exclusively focused on the cell therapy industry and has served over 100 clients since 1999. PCT provides a wide range of innovative services including product and process development, GMP manufacturing, engineering and automation, cell and tissue processing, logistics, storage and distribution, as well as expert consulting and regulatory support. For more information on Caladrius please visit www.caladrius.com and for more information on PCT please visit www.pctcaladrius.com. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management’s current expectations, as of the date of this press release, and involve certain risks and uncertainties. All statements other than statements of historical fact contained in this press release are forward-looking statements. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors. Factors that could cause future results to materially differ from the recent results or those projected in forward-looking statements include the “Risk Factors” described in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on March 15, 2016, and in the Company’s other periodic filings with the SEC. The Company’s further development is highly dependent on, among other things, future medical and research developments and market acceptance, which are outside of its control.


News Article | November 7, 2016
Site: globenewswire.com

BASKING RIDGE, N.J., Nov. 07, 2016 (GLOBE NEWSWIRE) -- Caladrius Biosciences, Inc. (NASDAQ:CLBS) (“Caladrius” or the “Company”), a cell therapy company combining an industry-leading development and manufacturing services provider through its subsidiary PCT, LLC a Caladrius Company™ (“PCT”) with a select therapeutic development pipeline, announces financial results for the three and nine months ended September 30, 2016. Business and financial highlights for the third quarter of 2016 and recent weeks include: “Throughout 2016, we consistently increased revenues at our PCT subsidiary and are poised to achieve our stated goal of 2016 annual revenue in excess of $30 million, which represents annual growth of more than 30%. In addition, year-to-date we secured over $50 million in strategic and/or committed financings, about half of which was non-dilutive with the remainder under favorable terms relative to the market rates for companies like ours. We also paid back to our lender over $9 million of long-term debt, significantly reduced our operating expenses and monetized non-core assets, all while advancing our key immune modulation program’s Phase 2 clinical study of CLBS03 to treat T1D,” stated David J. Mazzo, Ph.D., Chief Executive Officer of Caladrius. “We are particularly pleased with the progress of The Sanford Project: T-Rex Study in T1D.  We completed enrollment of the first cohort of 19 patients and were delighted that the DSMB recommended continuation of the study based on a favorable safety assessment. We have begun enrolling patients into the second cohort of this 111-patient study earlier than originally expected and plan to reach the 50% enrollment mark in mid-2017. Enrollment of the 70th patient, which triggers an $8.4 million capital infusion under the terms of the September private placements, is expected to occur shortly thereafter.  We continue to benefit from the support of Sanford Research. In addition to their equity investment, Sanford has agreed to extend operational support at their clinical sites for the remainder of the study. We continue to be excited by the promise of CLBS03, a novel therapeutic being developed to address the significant unmet medical need in this chronic disease that affects children and young adults. “We have made significant achievements across a number of key areas that we believe position Caladrius for continued growth and success throughout the balance of 2016 and beyond,” concluded Dr. Mazzo. Total revenues for the third quarter of 2016 increased 58% to $9.3 million compared with $5.9 million for the third quarter of 2015 and increased 12% compared with $8.3 million for the second quarter of 2016.  Gross margin on revenues was 8% in the third quarter of 2016 compared with 18% in the third quarter of 2015, directly impacted by the non-payment of approximately $600,000 in billings for work the Company performed and billed to a single customer during the third quarter of 2016, which customer is currently experiencing financial difficulties. Accordingly, the Company has delayed revenue recognition until such time as payment is reasonably assured.  The Company continues to work with this client to obtain payment and will recognize any such receipts as revenue in the periods received. Research and development (R&D) expenses for the third quarter of 2016 decreased 58% to $2.6 million compared with $6.3 million for the third quarter of 2015. The majority of current quarter expenses were dedicated to the Company’s immune modulation platform and, specifically, costs related to the T-Rex Study. The decline in R&D expenses over the prior year quarter was primarily related to the discontinuation of non-core R&D programs announced at the beginning of 2016 and related reductions in R&D staffing and departmental costs. Selling, general and administrative (SG&A) expenses for the three months ended September 30, 2016 were $4.9 million, a small reduction from $5.1 million reported for the same period in 2015. This reflected significantly lower operational and compensation-related costs during the current year quarter compared with the prior year quarter, partially offset by higher equity-based compensation expenses compared with the prior year quarter. The operating loss for the third quarter of 2016 was $6.9 million compared with an operating loss of $10.4 million for the third quarter of 2015, reflecting higher revenues and lower R&D expenses. The Company reported a net loss attributable to Caladrius common stockholders for the third quarter of 2016 of $6.9 million, or $1.09 per share, compared with a net loss attributable to Caladrius common stockholders for the third quarter of 2015 of $11.4 million, or $2.06 per share. Total revenues for the nine months ended September 30, 2016 increased 68% to $25.1 million compared with $14.9 million for the first nine months of 2015.  Gross margin for the first nine months of 2016 was 13% compared with 6% for the first nine months of 2015. R&D expenses for the first nine months of 2016 decreased to $12.5 million compared with $20.7 million for the first nine months of 2015. The decline in R&D expenses over the first nine months of 2015 was primarily related to the discontinuation of non-core R&D programs announced at the beginning of 2016 and related reductions in R&D staffing and departmental costs. SG&A expenses decreased to $16.1 million for the first nine months of 2016 compared with $25.0 million for the same period in 2015.  This reflected operational and compensation-related cost reductions, as well as equity-based compensation expenses that were significantly below the prior year SG&A expense levels. The operating loss for the first nine months of 2016 was $25.4 million compared with an operating loss of $54.1 million for the first nine months of 2015. The net loss attributable to Caladrius common stockholders for the nine months ended September 30, 2016 was $26.7 million, or $4.45 per share, compared with a net loss attributable to Caladrius common stockholders for the nine months ended September 30, 2015 of $47.7 million, or $10.40 per share. As of September 30, 2016, Caladrius had cash and cash equivalents of $18.6 million, which included $10.6 million received from the previously announced equity financing in September 2016 and the payment of $3.0 million to Oxford Finance LLC for repayment of long-term debt. Net cash used in operating activities for the nine months ended September 30, 2016 was $20.3 million, compared with $30.5 million for the nine months ended September 30, 2015. Caladrius also invested $2.3 million in capital expenditures, primarily related to improvements to PCT’s Allendale, N.J. manufacturing facility. The Company updates its previous 2016 guidance as follows: As previously announced, Caladrius management will host a conference call to discuss these results and provide a company update today at 5:00 pm Eastern Time. To participate in the conference call, dial 877-562-4460 (U.S.) or 513-438-4106 (international) and provide conference ID 95709220. To access the live webcast, visit the Investor Relations section of the Company’s website at www.caladrius.com/events.  The webcast will be archived on the website for 90 days. Caladrius Biosciences, Inc. is advancing a proprietary platform technology for immunomodulation by pioneering the use of regulatory T cells as an innovative therapy for recent onset type 1 diabetes.  The product candidate, CLBS03, is the subject of an ongoing Phase 2 clinical trial (The Sanford Project: T-Rex study) in collaboration with Sanford Research, and has been granted Orphan Drug and Fast Track designation by the U.S. Food and Drug Administration and Advanced Therapeutic Medicinal Product classification by the European Medicines Agency.  The Company’s PCT subsidiary is a leading development and manufacturing partner to the cell therapy industry.  PCT works with its clients to overcome the fundamental challenges of cell therapy manufacturing by providing a wide range of innovative services including product and process development, GMP manufacturing, engineering and automation, cell and tissue processing, logistics, storage and distribution, as well as expert consulting and regulatory support. PCT and Hitachi Chemical Co., Ltd. have entered into a strategic global collaboration to accelerate the creation of a global commercial cell therapy development and manufacturing enterprise with deep engineering expertise.  For more information, visit www.caladrius.com. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management’s current expectations, as of the date of this press release, and involve certain risks and uncertainties. All statements other than statements of historical fact contained in this press release are forward-looking statements. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors. Factors that could cause future results to materially differ from the recent results or those projected in forward-looking statements include the “Risk Factors” described in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on March 15, 2016, and in the Company’s other periodic filings with the SEC. The Company’s further development is highly dependent on, among other things, future medical and research developments and market acceptance, which are outside of its control.


Sanford Research to Provide Operational Support at its Clinical Sites for Remainder of Trial BASKING RIDGE, N.J., Oct. 31, 2016 (GLOBE NEWSWIRE) -- Caladrius Biosciences, Inc. (NASDAQ:CLBS) (“Caladrius” or the “Company”), a cell therapy company combining a unique, promising therapeutic development pipeline with an industry-leading development and manufacturing services provider through its subsidiary PCT, LLC a Caladrius Company™ (“PCT”), today announced that the independent Data Safety Monitoring Board (“DSMB”) for its Phase 2, The Sanford Project: T-Rex Study recommended that the trial proceed with the enrollment of the prescribed second cohort of subjects in the study to meet the target of 111 total participants. The Company’s decision to resume enrollment ahead of the original timeline represents an acceleration of the program. The decision was made in consultation with external clinical advisors based on a favorable safety profile for the first cohort of 19 subjects who reached their 28-day post-treatment follow-up. Sanford Research, the Company’s collaborator for the study, has agreed to extend operational support at its participating clinical sites for the remainder of the Study. The study is evaluating CLBS03 (the Company’s product candidate consisting of autologous expanded regulatory T cells, or Tregs) as a treatment for recent-onset type 1 diabetes (T1D). Caladrius has modified the T-Rex study protocol to allow for an earlier than planned resumption of enrollment for the remaining patients based on the DSMB recommendation after the 28-day, rather than three-month, evaluation of the first cohort. Based on the earlier than originally expected recommencement of Study enrollment and the high interest from subjects and investigators in the Study experienced from the first cohort, the Company now expects to reach the important milestone of treating 50% of subjects by mid-2017. The results from a pre-specified interim analysis of early therapeutic effect for the Study triggered after approximately 50% of subjects reach the 6-month post-treatment follow-up visit is expected to be announced late 2017/early 2018. The enrollment of the 70th subject in the Study, expected to occur in mid-2017, will trigger an expected $8.4 million infusion of capital pursuant to the terms of the recently announced private placements of Caladrius common stock. CLBS03 has received Fast Track and Orphan Drug designations from the FDA as well as Advanced Therapeutic Medicinal Product (ATMP) classification from the European Medicines Agency. “We are delighted to have identified multiple means by which we can accelerate our timeline for the T-Rex study and to have achieved this positive assessment of clinical safety earlier than originally planned. These results augment the existing body of evidence supporting the notion that CLBS03 has a favorable safety profile,” said David J. Mazzo, Ph.D., Chief Executive Officer of Caladrius. “We look forward to efficiently executing on the remainder of the T-Rex study, driving towards an understanding of CLBS03’s therapeutic effect in adolescents with recent-onset type 1 diabetes, starting with the planned interim analysis based upon a 6-month follow-up of ~50% of the targeted enrollment planned to occur late 2017 or early 2018.” Sanford Research (“Sanford”), has extended the agreement with Caladrius to provide operational support for the T-Rex Study beyond the first cohort to the remainder of the study. Sanford will provide and cover the costs of its clinical performance sites. Sanford’s initial support resulted in the enrollment of most of the first cohort of subjects and its recent agreement to make a $5 million equity investment in Caladrius will contribute to the execution of the remainder of the Study. Sanford Research is a non-profit organization that is part of Sanford Health and supports an emerging translational research center focused on finding a cure for T1D, called the Sanford Project. “Patients with type 1 diabetes benefit from having access to the newest and most innovative treatment options like cell therapy,” said David Pearce, Ph.D., executive vice president for Sanford Research. “Sanford understands how essential collaborations with organizations like Caladrius are to discovering those treatments and making them accessible to patients through clinical trials.” The landmark study, which is being conducted in collaboration with Sanford Research, a Sanford Health subsidiary, is a prospective, randomized, placebo-controlled, double-blind Phase 2 clinical trial to evaluate the safety and efficacy of CLBS03 as a treatment for T1D, in 111 subjects age 12 to 17 with recent-onset T1D. Subjects are randomized into one of three groups to receive, through a single administration, either a high dose of CLBS03, a low dose of CLBS03 or placebo. Enrollment of the first cohort of 19 subjects, designated for a preliminary safety evaluation, was completed in August 2016. The key endpoints for the trial are the standard medical and regulatory endpoints for a T1D trial and include preservation of C-peptide, an accepted measure for pancreatic beta cell function; insulin use; severe hypoglycemic episodes; and glucose and hemoglobin A1c levels. For more information on The Sanford Project: T-Rex Study, please visit https://clinicaltrials.gov/ct2/show/NCT02691247. Sanford Health is an integrated health system headquartered in the Dakotas. It is one of the largest health systems in the nation with 45 hospitals and nearly 300 clinics in nine states and four countries. Sanford Health’s 28,000 employees, including more than 1,300 physicians, make it the largest employer in the Dakotas. Nearly $1 billion in gifts from philanthropist Denny Sanford have allowed for several initiatives, including global children's clinics, genomic medicine and specialized centers researching cures for type 1 diabetes, breast cancer and other diseases. For more information, visit sanfordhealth.org. Caladrius Biosciences, Inc. is advancing a proprietary platform technology for immunomodulation by pioneering the use of T regulatory cells as an innovative therapy for recent onset type 1 diabetes.  The product candidate, CLBS03, is the subject of an ongoing Phase 2 clinical trial (The Sanford Project: T-Rex Study) in collaboration with Sanford Research, and has been granted Orphan Drug and Fast Track designation by the U.S. Food and Drug Administration and Advanced Therapeutic Medicinal Product classification by the European Medicines Agency.  The Company’s PCT subsidiary is a leading development and manufacturing partner to the cell therapy industry.  PCT works with its clients to overcome the fundamental challenges of cell therapy manufacturing by providing a wide range of innovative services including product and process development, GMP manufacturing, engineering and automation, cell and tissue processing, logistics, storage and distribution, as well as expert consulting and regulatory support. PCT and Hitachi Chemical Co., Ltd. have entered into a strategic global collaboration to accelerate the creation of a global commercial cell therapy development and manufacturing enterprise with deep engineering expertise.   For more information, visit www.caladrius.com. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management’s current expectations, as of the date of this press release, and involve certain risks and uncertainties. All statements other than statements of historical fact contained in this press release are forward-looking statements, including statements regarding the enrollment of the second cohort of subjects in the T-Rex Study, the planned interim analysis based upon a 6-month follow-up of approximately 50% of the targeted enrollment, and the enrollment of the 70th subject in the Study. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors. Factors that could cause future results to materially differ from the recent results or those projected in forward-looking statements include the “Risk Factors” described in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on March 15, 2016, and in the Company’s other periodic filings with the SEC. The Company’s further development is highly dependent on, among other things, future medical and research developments and market acceptance, which are outside of its control.


BASKING RIDGE, N.J., Nov. 02, 2016 (GLOBE NEWSWIRE) -- Caladrius Biosciences, Inc. (NASDAQ:CLBS) (“Caladrius” or the “Company”), a cell therapy company combining an industry-leading development and manufacturing services provider (PCT) with a unique, promising therapeutic development pipeline, announces today that the Company will release financial results for the third quarter of 2016 after the U.S. financial markets close on Monday, November 7, 2016. Caladrius’ management will host a conference call for the investment community beginning at 5:00 pm ET on Monday, November 7, 2016, to discuss the financial results, provide a company update and answer questions. Shareholders and other interested parties may participate in the conference call by dialing 877-562-4460 (U.S.) or 513-438-4106 (international) and providing conference ID 95709220. The call will also be broadcast live on the Internet via the Company’s website at www.caladrius.com/events. The webcast will be archived on the Company’s website for 90 days. About Caladrius Biosciences Caladrius Biosciences, Inc. is advancing a proprietary platform technology for immunomodulation by pioneering the use of T regulatory cells as an innovative therapy for recent onset type 1 diabetes.  The product candidate, CLBS03, is the subject of an ongoing Phase 2 clinical trial (The Sanford Project: T-Rex study) in collaboration with Sanford Research, and has been granted Orphan Drug and Fast Track designation by the U.S. Food and Drug Administration and Advanced Therapeutic Medicinal Product classification by the European Medicines Agency.  The Company’s PCT subsidiary is a leading development and manufacturing partner to the cell therapy industry.  PCT works with its clients to overcome the fundamental challenges of cell therapy manufacturing by providing a wide range of innovative services including product and process development, GMP manufacturing, engineering and automation, cell and tissue processing, logistics, storage and distribution, as well as expert consulting and regulatory support. PCT and Hitachi Chemical Co., Ltd. have entered into a strategic global collaboration to accelerate the creation of a global commercial cell therapy development and manufacturing enterprise with deep engineering expertise.   For more information, visit www.caladrius.com. Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management’s current expectations, as of the date of this press release, and involve certain risks and uncertainties. All statements other than statements of historical fact contained in this press release are forward-looking statements. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors. Factors that could cause future results to materially differ from the recent results or those projected in forward-looking statements include the “Risk Factors” described in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on March 15, 2016, and in the Company’s other periodic filings with the SEC. The Company’s further development is highly dependent on, among other things, future medical and research developments and market acceptance, which are outside of its control.


News Article | February 15, 2017
Site: www.prweb.com

A national breast cancer research project has chosen Sanford Health to be the repository for the specimens collected as part of the 100,000 woman study. The five-year study is called Women Informed to Screen Depending on Measures of risk, or WISDOM, and is being conducted by the Athena Breast Health Network, a collaboration among five University of California medical centers and Sanford Health’s Edith Sanford Breast Center. Investigators are studying routine annual screenings and personalized screenings based on genetic information to determine which method is more effective in reducing false positives and misdiagnoses of breast cancer. Sanford’s genomic lab will house the specimens collected from consenting women as part of this research. The study will enroll 100,000 women across the United States. Researchers from across the globe will have access to the data collected to use in other breast cancer studies. “Sanford Health has been an outstanding partner in our breast health research and clinical care initiatives here at the University of California,” said Sandy Borowsky, the principal investigator at the University of California, Davis site of Athena. “Sanford demonstrated a commitment to improving care for women through innovative thinking and the hard work of collecting data across multiple sites. Their professionalism and institutional support for a first class biospecimen lab made the choice clear. It’s a true win-win opportunity.” The Athena Breast Health Network in 2015 received a $14.1 million grant from the Patient-Centered Outcomes Research Institute, or PCORI, to fund WISDOM. Edith Sanford Breast Center has been a member of Athena since 2013. Other partners include the University of California campuses in San Francisco, San Diego, Davis, Los Angeles and Irvine. “Sanford Health enjoys beneficial integration of its clinical and research operations, which has provided us the infrastructure to support the WISDOM repository,” said David Pearce, Ph.D., executive vice president for Sanford Research. “The data gathered and stored here have the potential to improve breast cancer screenings for women everywhere.” Women age 40-74 years old who have not had a prior breast cancer diagnosis and receive care at an Athena site are eligible to enroll. Edith Sanford Breast Center in Sioux Falls expects to open enrollment in early 2017. About Sanford Health Sanford Health is an integrated health system headquartered in the Dakotas. It is one of the largest health systems in the nation with 45 hospitals and nearly 300 clinics in nine states and four countries. Sanford Health’s 28,000 employees, including more than 1,300 physicians, make it the largest employer in the Dakotas. Nearly $1 billion in gifts from philanthropist Denny Sanford have allowed for several initiatives, including global children's clinics, genomic medicine and specialized centers researching cures for type 1 diabetes, breast cancer and other diseases. For more information, visit sanfordhealth.org.


News Article | February 28, 2017
Site: www.prweb.com

Cancer Breakthroughs 2020, the world’s most comprehensive cancer collaborative initiative focusing on combination immunotherapy, has selected Sanford Health as one of three sites nationwide to launch the program’s first clinical trial. The study will explore an immunotherapy vaccine for patients with certain types of advanced breast cancer. Cancer Breakthroughs 2020 was created in early 2016 by Dr. Patrick Soon-Shiong, to facilitate collaboration among multinational pharmaceutical, biotechnology companies, academic centers and community oncologists in an effort to test novel immunotherapy protocols in combination with other treatment methods. “Our mission at Cancer Breakthroughs 2020 is to turn cancer into a chronic disease, not a life-threatening disease,” said Soon-Shiong. “Sanford Health is a key partner in helping us achieve that goal. Their drive to bring advanced cancer treatment options to even the most rural areas shows their commitment to fighting cancer.” Amy Sanford, M.D., an oncologist at Edith Sanford Breast Center in Sioux Falls, is the trial’s principal investigator. Her team will study if an immunotherapy vaccine designed to strengthen the body’s immune system can help patients fight breast cancer that cannot be treated with surgery or that has metastasized and is characterized by the HER2 gene. “After years of offering clinical trials and ranking the potential of immunotherapy high on Sanford’s list of priorities, the power of our comprehensive clinical research program is evident by Cancer Breakthroughs 2020’s selection of Sanford to help start the inaugural study of the project,” said David Pearce, Ph.D., executive vice president for Sanford Research. “The next generation standard of care will be the result of teamwork among organizations like Cancer Breakthroughs 2020 and Sanford Health.” Sanford Health has been involved in Cancer Breakthroughs 2020 since its inception early last year. In February, Sanford was announced as a founding member of the Cancer Breakthroughs 2020 Pediatrics Consortium. Sam Milanovich, M.D., is among the national experts using comprehensive cancer molecular diagnostic testing to study pediatric forms of cancer. This summer, Patrick Soon-Shiong, M.D., the founder of Cancer Breakthroughs 2020, finalized a relationship with Sanford Health to work clinical trials for human papillomavirus-, or HPV-, related cancers like head and neck cancer, cervical cancer and anal cancer. The study is open at Edith Sanford Breast Center in Sioux Falls. For information or to enroll, call 1-87-SURVIVAL. About Cancer Breakthroughs 2020 The Cancer Breakthroughs 2020 program is one of the most comprehensive cancer collaborative initiative launched to date, seeking to accelerate the potential of combination immunotherapy as the next generation standard of care in cancer patients. This initiative aims to explore a new paradigm in cancer care by initiating randomized Phase II trials in patients at all stages of disease in 20 tumor types in 20,000 patients within the next 36 months. These findings will inform Phase III trials and the aspirational breakthroughs to develop an effective vaccine-based immunotherapy to combat cancer by 2020. For more information, please visit http://www.cancerbreakthroughs2020.org and follow @Cancer2020 on Twitter. About Sanford Health Sanford Health is an integrated health system headquartered in the Dakotas. It is one of the largest health systems in the nation with 45 hospitals and nearly 300 clinics in nine states and four countries. Sanford Health’s 28,000 employees, including more than 1,300 physicians, make it the largest employer in the Dakotas. Nearly $1 billion in gifts from philanthropist Denny Sanford have allowed for several initiatives, including global children's clinics, genomic medicine and specialized centers researching cures for type 1 diabetes, breast cancer and other diseases. For more information, visit sanfordhealth.org.

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