On April 15, 2021 Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage biotechnology company developing allogeneic CAR T and in vivo gene correction therapies with its ARCUS genome editing platform, reported that Alan List, M.D. has been appointed as the Company’s Chief Medical Officer and a member of the senior leadership team at Precision BioSciences (Press release, Precision Biosciences, APR 15, 2021, View Source [SID1234578081]). Dr. List is a world-renowned hematologist with extensive academic and clinical experience in the research and development of hematology and oncology products. He has led clinical development programs for multiple FDA-approved drugs to treat hematologic malignancies, including myelodysplastic syndromes, acute leukemia, multiple myeloma, and lymphoma.

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"We are very pleased to welcome Alan to the senior leadership team of Precision BioSciences," said Matt Kane, Chief Executive Officer and Co-Founder of Precision BioSciences. "With three hematology products in the clinic and a fourth entering clinical trials soon, Alan’s deep clinical expertise in hematology and oncology, including pioneering work to develop novel products from the laboratory to the clinic, will be a strong addition to the Precision team. Over the past 12 months, Alan has been intimately involved in our clinical strategy to develop our lead allogeneic CAR T therapy, PBCAR0191, as well as the design of our clinical program for PBCAR19B, our next generation, stealth cell program. We believe that Alan’s leadership will be critical to the successful execution of our clinical development strategy."

Since April 2020, Dr. List has been a strategic clinical advisor to Precision BioSciences, providing advice to the company and its Board of Directors on its clinical stage and pre-clinical allogeneic CAR T programs. Prior to joining Precision BioSciences, Dr. List served in various roles at the Moffitt Cancer Center, including as President and Chief Executive Officer from 2012 to 2019; Executive VP, Physician in Chief from 2008 to 2012 and Chief of the Malignant Hematology Division from 2003 to 2008. Dr. List is internationally recognized for his many contributions in the development of effective treatment strategies for myelodysplastic syndrome (MDS) and acute myeloid leukemia. His pioneering work led to the development of Revlimid (lenalidomide) a transformational treatment for patients with MDS and multiple myeloma.

Dr. List is the author of more than 425 peer-reviewed articles and books. He previously served as the President for the Society of Hematologic Oncology and a member of the MDS Foundation Board of Directors. Dr. List is an active member of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), the American Society of Hematology (ASH) (Free ASH Whitepaper) and the American Association for Cancer Research (AACR) (Free AACR Whitepaper). He is a Charter Fellow in the National Academy of Inventors, an inductee in the Florida Inventors Hall of Fame, and holds 18 U.S. patents and >45 applications filed. Dr. List was 2016 recipient of the Celgene Career Achievement Award for Clinical Research in Hematology, and other recognitions including the General Motors Cancer Research Foundation Merit Award, the J.P. McCarthy Foundation International Prize, the Emil J. Freireich Award, the Joshua Lederberg Society, and the Aplastic Anemia & MDS International Foundation Leadership in Science Award.

Dr. List received B.S. and M.S. degrees from Bucknell University and earned his M.D. from the University of Pennsylvania. He is board certified in internal medicine, hematology, and medical oncology. He completed his residency in internal medicine at Good Samaritan Medical Center in Phoenix, Arizona and fellowships in hematology and medical oncology at Vanderbilt University Medical Center. Prior to joining the Moffitt Cancer Center in 2003, Dr. List held academic and clinical appointments at the University of Arizona.

"After advising Precision BioSciences on its clinical trial programs for nearly a year, I’m very excited to join as the Chief Medical Officer as we approach the launch of the first of our stealth CAR T programs. I look forward to working with the management team and the clinical team to advance the development of our potentially breakthrough allogeneic CAR T cell programs, including PBCAR0191 and PBCAR19B. I’m particularly optimistic about the potential opportunity to bring novel cell therapies to patients who suffer from hematologic malignancies, such as non-Hodgkin lymphoma, B-cell acute lymphoblastic leukemia, and multiple myeloma," said Dr. List. "I’m also looking forward to interacting with the clinical investigators who are conducting our clinical trials at leading academic centers across the country."

Dr. List will succeed Chris Heery, M.D., who is leaving Precision BioSciences to pursue other opportunities. Dr. Heery will continue to serve as a consultant to the company to ensure a smooth transition in the conduct of clinical trials underway at Precision.

"During Chris’ time with the company, Precision successfully transitioned PBCAR20A and PBCAR269A into Phase 1 clinical trials and designed the Phase 1 clinical trial for PBCAR19B. We thank Chris for his contributions to Precision BioSciences and wish him success in his future endeavors," added Mr. Kane.

On April 15, 2021 Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage biotechnology company developing allogeneic CAR T and in vivo gene correction therapies with its ARCUS genome editing platform, reported that Alan List, M.D. has been appointed as the Company’s Chief Medical Officer and a member of the senior leadership team at Precision BioSciences (Press release, Precision Biosciences, APR 15, 2021, View Source [SID1234578080]). Dr. List is a world-renowned hematologist with extensive academic and clinical experience in the research and development of hematology and oncology products. He has led clinical development programs for multiple FDA-approved drugs to treat hematologic malignancies, including myelodysplastic syndromes, acute leukemia, multiple myeloma, and lymphoma.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"We are very pleased to welcome Alan to the senior leadership team of Precision BioSciences," said Matt Kane, Chief Executive Officer and Co-Founder of Precision BioSciences. "With three hematology products in the clinic and a fourth entering clinical trials soon, Alan’s deep clinical expertise in hematology and oncology, including pioneering work to develop novel products from the laboratory to the clinic, he will be a strong addition to the Precision team. Over the past 12 months, Alan has been intimately involved in our clinical strategy to develop our lead allogeneic CAR T therapy, PBCAR0191, as well as the design of our clinical program for PBCAR19B, our next generation, stealth cell program. We believe that Alan’s leadership will be critical to the successful execution of our clinical development strategy."

Since April 2020, Dr. List has been a strategic clinical advisor to Precision BioSciences, providing advice to the company and its Board of Directors on its clinical stage and pre-clinical allogeneic CAR T programs. Prior to joining Precision BioSciences, Dr. List served in various roles at the Moffitt Cancer Center, including as President and Chief Executive Officer from 2012 to 2019; Executive VP, Physician in Chief from 2008 to 2012 and Chief of the Malignant Hematology Division from 2003 to 2008. Dr. List is internationally recognized for his many contributions in the development of effective treatment strategies for myelodysplastic syndrome (MDS) and acute myeloid leukemia. His pioneering work led to the development of Revlimid (lenalidomide) a transformational treatment for patients with MDS and multiple myeloma.

Dr. List is the author of more than 425 peer-reviewed articles and books. He previously served as the President for the Society of Hematologic Oncology and a member of the MDS Foundation Board of Directors. Dr. List is an active member of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), the American Society of Hematology (ASH) (Free ASH Whitepaper) and the American Association for Cancer Research (AACR) (Free AACR Whitepaper). He is a Charter Fellow in the National Academy of Inventors, an inductee in the Florida Inventors Hall of Fame, and holds 18 U.S. patents and >45 applications filed. Dr. List was 2016 recipient of the Celgene Career Achievement Award for Clinical Research in Hematology, and other recognitions including the General Motors Cancer Research Foundation Merit Award, the J.P. McCarthy Foundation International Prize, the Emil J. Freireich Award, the Joshua Lederberg Society, and the Aplastic Anemia & MDS International Foundation Leadership in Science Award.

Dr. List received B.S. and M.S. degrees from Bucknell University and earned his M.D. from the University of Pennsylvania. He is board certified in internal medicine, hematology, and medical oncology. He completed his residency in internal medicine at Good Samaritan Medical Center in Phoenix, Arizona and fellowships in

hematology and medical oncology at Vanderbilt University Medical Center. Prior to joining the Moffitt Cancer Center in 2003, Dr. List held academic and clinical appointments at the University of Arizona.

"After advising Precision BioSciences on its clinical trial programs for nearly a year, I’m very excited to join as the Chief Medical Officer as we approach the launch of the first of our stealth CAR T programs. I look forward to working with the management team and the clinical team to advance the development of our potentially breakthrough allogeneic CAR T cell programs, including PBCAR0191 and PBCAR19B. I’m particularly optimistic about the potential opportunity to bring novel cell therapies to patients who suffer from hematologic malignancies, such as non-Hodgkin lymphoma, B-cell acute lymphoblastic leukemia, and multiple myeloma," said Dr. List. "I’m also looking forward to interacting with the clinical investigators who are conducting our clinical trials at leading academic centers across the country."

Dr. List will succeed Chris Heery, M.D., who is leaving Precision BioSciences to pursue other opportunities. Dr. Heery will continue to serve as a consultant to the company to ensure a smooth transition in the conduct of clinical trials underway at Precision.

"During Chris’ time with the company, Precision successfully transitioned PBCAR20A and PBCAR269A into Phase 1 clinical trials and designed the Phase 1 clinical trial for PBCAR19B. We thank Chris for his contributions to Precision BioSciences and wish him success in his future endeavors," added Mr. Kane.

On April 15, 2021 Precision BioSciences Inc. (Nasdaq: DTIL), a clinical stage biotechnology company developing allogeneic CAR T and in vivo gene correction therapies with its ARCUS genome editing platform, reported it has entered into a Program Purchase Agreement to reacquire all global development and commercialization rights for all CAR T partnered programs covered under its Development and Commercial License Agreement with Servier (Press release, Precision Biosciences, APR 15, 2021, View Source [SID1234578079]). This includes its two clinical stage CD19-targeting allogeneic CAR T candidates, PBCAR0191 and PBCAR19B stealth cell, as well as four additional product targets.

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"We are excited about the potential of our allogeneic CAR T pipeline to deliver off-the-shelf treatments for patients with cancer," said Matt Kane, CEO and Co-Founder of Precision BioSciences. "We believe we are in a unique position with multiple near-term opportunities to achieve success with allogeneic CAR T cells targeting CD19. Our lead candidate, PBCAR0191, continues to look promising when paired with our enhanced lymphodepletion regimen, and our immune-evading PBCAR19B stealth cell candidate is poised to enter the clinic soon. We seized the opportunity to reacquire these two CD19 programs, as well as four additional targets that were selected by Servier in 2020 to regain global commercial rights and full control of our clinical programs, allowing us to focus our resources and enable rapid decision making."

Under the terms of the Program Purchase Agreement, Servier will receive $1.25 million in cash and Precision has agreed to waive earned, but as-yet unpaid, milestones totaling $18.75 million that would have otherwise been payable to Precision. Servier is also eligible to receive milestones and low- to mid-single-digit royalties subject to product development achievement. With respect to products directed to CD19, Servier has certain rights of negotiation if Precision elects to re-partner the programs.

"Precision was a very good partner for us, and we continue to believe their proprietary, single-step cell engineering technology has the potential to open the door to an off-the-shelf approach for addressing cancer," said Patrick Therasse, Deputy Head of R&D Oncology at Servier. "While we have made the strategic decision to refocus our R&D activities and we will no longer be taking an active role in the Precision programs, we continue to believe they have multiple opportunities, including the stealth cell approach, to benefit patients with hematologic malignancies and solid tumors, so we are pleased to be able to participate in the potential future success of these programs."

Subsequent to Precision’s December 2020 interim Phase 1/2a study data update for PBCAR0191, enrollment in the study has continued, with a focus on dose level 3 (3 x 106 cells/kg) following enhanced lymphodepletion (eLD)1. Initial response rates are consistent with the high response rates reported by Precision in December 2020, and the safety profile continues to be acceptable. Precision intends to monitor the results for durability from this eLD regimen and report updated interim results by mid-2021.

By the end of May 2021, Precision expects to dose the first patient with PBCAR19B, its second CD19 allogeneic CAR T candidate that is engineered with Precision’s proprietary stealth cell technology. Although it has not finalized its full financial results for the first quarter ended March 31, 2021, Precision BioSciences had cash and cash equivalents of approximately $193 million as of March 31, 2021 and continues to expect that cash and cash equivalents, expected operational receipts, and available credit will allow the Company to continue its operations into 2023.

Company-Hosted Conference Call and Webcast Information

Precision’s management team will host a conference call and webcast at 5:00 p.m. ET, Thursday, April 15, 2021 to discuss today’s announcement. The dial-in conference call numbers for domestic and international callers are (866) 996-7202 and (270) 215-9609, respectively. The conference ID number for the call is 8170529. Participants may access the live webcast and the accompanying presentation materials on Precision’s website View Source in the Investors and Media section under Events and Presentations. An archived replay of the webcast will be available on Precision’s website for approximately 30 days.

About PBCAR0191 (Clinical Trials Study Identifier: NCT03666000)

PBCAR0191 is an investigational allogeneic CAR T in a Phase 1/2a clinical trial for the treatment of patients with R/R NHL and R/R B-ALL. PBCAR0191 was designed using Precision BioSciences’ novel and proprietary ARCUS genome editing platform. It has been granted Fast Track Designation by the FDA for the treatment of R/R B-ALL. Precision also holds Orphan Drug Designation from the FDA for this program in mantle cell lymphoma, an aggressive subtype of NHL.

In December 2020, Precision BioSciences reported positive interim results from this study, in which 27 patients with R/R NHL or R/R B-ALL were dosed with PBCAR0191 CAR T therapy and showed no graft versus host disease, no grade ≥ 3 cytokine release syndrome, and no grade ≥ 3 neurotoxicity. For those NHL and B-ALL patients dosed with PBCAR0191, when combined with eLD, objective response rates reached 83% (5/6).

About PBCAR19B (Clinical Trials Study Identifier: NCT04649112)

PBCAR19B is a next-generation, stealth cell candidate for patients with CD19-positive malignancies such as R/R NHL. PBCAR19B is designed to improve the persistence of allogeneic CAR T cells following infusion by reducing rejection by T cells and NK cells. In addition to the CAR gene, the PBCAR19B stealth cell vector carries a short hairpin RNA that suppresses expression of beta-2 microglobulin, a component of Class I Major Histocompatibility Complex (MHC) molecules found on the cell surface. Reducing or knocking-down Class I MHC expression on allogeneic CAR T cells has been shown to reduce CAR T cell killing by cytotoxic T cells. The PBCAR19B vector also carries an HLA-E gene intended to reduce rejection of CAR T cells by NK cells that can be stimulated as a result of reduced MHC molecule expression on the cell surface.

On April 15, 2021 Veracyte, Inc. (Nasdaq: VCYT) reported that Keith Kennedy, chief financial officer and chief operating officer, will retire from the company, effective May 15, 2021, following the company’s release of its full quarterly financial results and the filing of its Form 10-Q for the first quarter 2021 (Press release, Veracyte, APR 15, 2021, View Source [SID1234578078]). Jane Alley, vice president and corporate controller, will become acting CFO until a replacement is named. Veracyte is conducting a search for a new CFO.

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"Keith has played a key role in Veracyte’s growth and success over the last four years and the board and I deeply appreciate his many contributions. These include building a strong financial infrastructure and team that we believe will help position us for continued success. Keith will be missed and we wish him the very best in his next chapter," said Bonnie Anderson, Veracyte’s chairman and chief executive officer.

Veracyte also announced preliminary results for the first quarter ended March 31, 2021.

The company expects to report total revenue of between $36 million and $37 million, including between $3.5 million and $3.8 million for urologic cancers, for the first quarter ended March 31, 2021, an increase of 17.3% at the midpoint of the total range, compared to the first quarter of 2020. The company expects product and reported testing volume of between 14,000 and 14,500 tests, including between 1,400 and 1,500 tests in urologic cancers, for the first quarter of 2021, an increase of 9.3% at the midpoint of the total range, compared to prior year. The foregoing amounts are preliminary, have not been audited or reviewed and are subject to change in connection with the completion of Veracyte’s financial statements for the first quarter ended March 31, 2021.

"We are off to a strong start for the year. Revenue and genomic testing and product volume continued to gain momentum in the first quarter and were further boosted by our acquisition in mid-March of Decipher Biosciences, with its market-leading prostate cancer test. We also remain on track to launch key pipeline products in the second half of the year, including our Percepta Nasal Swab test and Genomic Atlas in lung cancer and our Envisia classifier on the nCounter Analysis System in international markets," said Ms. Anderson.

Veracyte expects to announce full first quarter 2021 financial results on May 10, 2021, after market close. Management will host a conference call and webcast to discuss the company’s financial results and to provide a general business update, later that same day. Additional details on the call will be released in a separate press release.

On April 15, 2021 Avid Bioservices, Inc. (NASDAQ: CDMO) (the "company"), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality development and manufacturing services to biotechnology and pharmaceutical companies, reported that it has completed the redemption of all of the company’s outstanding 10.50% Series E Convertible Preferred Stock ("Series E Preferred Stock") as of April 12, 2021 (the "Redemption Date") (Press release, Avid Bioservices, APR 15, 2021, View Source [SID1234578077]).

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In a press release dated March 10, 2021, the company announced its intention to utilize a portion of the proceeds from its recent offering of exchangeable senior notes to redeem all of the company’s outstanding Series E Preferred Stock. Each share of Series E Preferred Stock was redeemed at a redemption price equal to the liquidation amount of $25.00 per share plus accrued and unpaid dividends per share up to, but excluding, the Redemption Date. As a result of the completed redemption, the Series E Preferred Stock is no longer outstanding nor listed as CDMOP on the NASDAQ Stock Market.