On August 6, 2019 Gamida Cell Ltd. (Nasdaq: GMDA), a leading cellular and immune therapeutics company, reported financial results for the quarter ended June 30, 2019 (Press release, Gamida Cell, AUG 6, 2019, View Source [SID1234538219]). The company also highlighted continued progress in advancing its clinical development candidates: omidubicel, an investigational advanced cell therapy in Phase 3 clinical development designed to enhance the life-saving benefits of hematopoietic stem cell (bone marrow) transplant for patients with hematologic malignancies, and GDA-201, an investigational, natural killer (NK) cell-based cancer immunotherapy in Phase 1 development in patients with non-Hodgkin lymphoma and multiple myeloma.

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"During the past quarter, Gamida Cell made important progress toward its goal of transforming the treatment landscape for patients with blood cancers and rare, serious hematologic diseases," stated Julian Adams, Ph.D., chief executive officer of Gamida Cell. "We are continuing to progress our multi-center, randomized Phase 3 study of omidubicel to enable a topline data readout, which is expected in the first half of 2020. As we look ahead toward the potential submission of a biologics license application next year, we are advancing key activities required to bring omidubicel to patients in a commercial setting. To help ensure that we will have sufficient and reliable commercial supply, we established a commercial manufacturing supply agreement with Lonza and engaged Biopharmax, a biopharmaceutical design and construction firm, to initiate the construction of our own commercial manufacturing facility in Israel."

"Our second cell therapy program, GDA-201, is also moving forward. We anticipate additional data from the ongoing Phase 1/2 clinical study in the second half of the year. We are also on track with our plans to develop a cryopreserved formulation of GDA-201 to enable a multi-center clinical study in patients with non-Hodgkin lymphoma," Dr. Adams continued. "Both omidubicel and GDA-201 are based on our proprietary cell expansion platform, which has the potential to further expand our pipeline. In June, we appointed Dr. Tracey Lodie to our team as chief scientific officer to set our scientific strategy and lead new translational research to further elucidate the potential of our technology and clinical development programs."

Program Highlights

Continued to advance the Phase 3 clinical study of omidubicel: Patient enrollment continued to progress in the Gamida Cell’s Phase 3 study of omidubicel in patients with high-risk hematologic malignancies. The international, randomized, multi-center study is designed to evaluate the safety and efficacy of omidubicel compared to standard umbilical cord blood for allogeneic bone marrow transplant in approximately 120 patients with no available matched donor. The company anticipates completing patient enrollment by the end of this year with topline data anticipated in first half of 2020.
Established agreements to support commercial manufacturing for omidubicel: In June, Gamida Cell and Lonza announced that the companies entered into a strategic manufacturing agreement for the future commercial production after potential FDA approval of omidubicel. This agreement follows a successful multi-year clinical manufacturing relationship and provides Gamida Cell with a path to commercial supply of omidubicel. Under this multi-year agreement, Lonza will construct and dedicate production suites at its Geleen, NL site for the anticipated commercial launch. Additionally, the agreement enables Gamida Cell to increase the number of dedicated production suites over time to ensure commercial supply. Gamida Cell also has the option of expanding further into Lonza’s global cell and gene therapy manufacturing network. In August, Gamida Cell signed an agreement with Biopharmax for the construction of suites for the commercial manufacture of omidubicel after potential FDA approval of omidubicel at a Gamida Cell-operated facility in Israel.
Initiated enrollment for Cohort 2 in the Phase 1/2 study of omidubicel in patients with severe aplastic anemia: In June, patient enrollment began in Cohort 2 of the investigator-sponsored, Phase 1/2 clinical study of omidubicel in patients with severe aplastic anemia, a rare and life-threatening blood disorder. Earlier this year, encouraging data from Cohort 1 were reported at the 2019 Transplantation & Cellular Therapy (TCT) Meeting. All three patients enrolled in Cohort 1 successfully underwent a bone marrow transplant consisting of omidubicel plus a haploidentical stem cell graft. The rapid engraftment, sustained hematopoiesis and accelerated immune recovery observed in these patients enabled the initiation of Cohort 2, where patients will be treated with omidubicel as a stand-alone graft.
Demonstrated continued progress with GDA-201 clinical development program: Gamida Cell continued to make progress with the GDA-201 clinical development program. The investigator-sponsored, Phase 1/2 clinical study of GDA-201 in patient with non-Hodgkin lymphoma and multiple myeloma is ongoing, with additional data expected in the second half of 2019. The company is developing a cryopreserved formulation of GDA-201 to enable a multi-center, multi-dose Phase 1/2 clinical study in patients with non-Hodgkin lymphoma, which is expected to begin next year.
Corporate Highlights

Completed public follow-on offering of approximately $40 million in gross proceeds: In July, Gamida Cell announced that the company closed an underwritten public offering of 7,000,000 ordinary shares and that the underwriters exercised in full their option to purchase an additional 1,050,000 ordinary shares at the public offering price of $5.00 per share. The aggregate gross proceeds to Gamida Cell from the offering, including the shares sold pursuant to the underwriters’ option, before deducting underwriting discounts and commission and offering expenses, were $40.3 million.
Bolstered management team with appointment of Tracey Lodie, Ph.D., as chief scientific officer: In June, the company announced the appointment of Tracey Lodie, Ph.D., as chief scientific officer. Prior to joining Gamida Cell, Dr. Lodie served as senior vice president, translational immunology at BlueRock Therapeutics, where she helped to advance their universal pluripotent stem cell platform into central nervous system, cardiovascular, and autoimmune therapeutic areas. She also served as vice president of immunology at Syros Pharmaceuticals, where she developed new autoimmunity and immuno-oncology research programs. Prior to Syros Pharmaceuticals, Dr. Lodie spent over 14 years at Sanofi-Genzyme, where she held roles of increasing responsibility. She obtained a PhD. in immunology and pathology at Boston University School of Medicine before completing a post-doctoral fellowship at Beth Israel Deaconess Medical Center in the Department of Hematology/Oncology.
Shawn Cline Tomasello and Stephen Wills elected to Board of Directors, reflecting company’s progress toward commercialization: In June, Shawn Cline Tomasello and Stephen T. Wills were elected to Gamida Cell’s board of directors. Ms. Tomasello has extensive experience in commercializing first-in-class medicines for the treatment of cancer, including Yescarta (at Kite Pharma, now part of Gilead Sciences) and Imbruvica (at Pharmacyclics, now part of AbbVie). Mr. Wills has extensive operational, financial and transactional experience over nearly three decades in the life sciences and accounting industries. He has served as chief financial officer of Palatin Technologies, a publicly-traded biotechnology company developing peptide therapeutics, since 1997 and also serves as Palatin’s chief operating officer and executive vice president.
Anticipated 2019-2020 Milestones

Gamida Cell’s anticipated program milestones in 2019-2020 are as follows:

Omidubicel

Complete enrollment in Phase 3 study of omidubicel in patients with hematologic malignancies by the end of 2019
Report topline data from the Phase 3 study of omidubicel in patients with hematologic malignancies in the first half of 2020
Complete BLA submission for omidubicel in hematologic malignancies in the second half of 2020, should Phase 3 data be positive
GDA-201

Complete patient enrollment in the ongoing Phase 1 study in the second half of 2019
Present additional data at a medical meeting in the second half of 2019
Initiate multi-center, Phase 1/2 clinical study in patients with NHL in 2020
Second Quarter 2019 Financial Results

Research and development (R&D) expenses in the second quarter of 2019 were $7.0 million and were also $7.0 million in the same period in 2018. R&D expenses were higher in the second quarter of 2019 compared to the same period in 2018 due to the advancement of omidubicel and GDA-201 but were offset by a $2.0 million increase in grants related to the Israeli Innovation Authority (IIA).
General and administrative expenses were $3.8 million for the second quarter of 2019, compared to $2.9 million in the same period in 2018. The difference was attributable mainly to a $0.4 million increase in cash and non-cash expenses related to hiring and establishing the U.S. headquarters as well as a $0.5 million increase in professional services, including an increase in expenses associated with being a publicly-traded company.
Finance income, net, was $16.8 million for the second quarter of 2019, compared to finance expenses, net, of $3.2 million in the same period in 2018. The net increase was primarily due to non-cash income resulting from the re-valuation of warrants, offset by non-cash expenses from the re-valuation of the IIA royalty-bearing grant liability.
Net income for the second quarter of 2019 was $6.0 million, compared to a net loss of $13.1 million in the same period in 2018.
As of June 30, 2019, Gamida Cell had total cash, cash equivalents and available-for-sale securities of $41.7 million, compared to $60.7 million as of December 31, 2018. The June 30, 2019, cash position excludes the aggregate gross proceeds from the company’s recent public follow-on offering, which were $40.3 million.

2019 Financial Guidance
Gamida Cell continues to expect cash used for ongoing operating activities in 2019 to range from $35 million to $40 million, reflecting anticipated expenditures to advance the company’s clinical programs.

Gamida Cell expects that its cash, cash equivalents and available-for-sale securities will support the company’s ongoing operating activities into the fourth quarter of 2020. This cash runway guidance is based on the company’s current operational plans and excludes any additional funding that may be received or business development activities that may be undertaken.

Conference Call Information
Gamida Cell will host a conference call today, August 6, 2019, at 8:30 a.m. ET to discuss these financial results and company updates. A live webcast of the conference call can be accessed in the "Investors" section of Gamida Cell’s website at www.gamida-cell.com. To participate in the live call, please dial 866-930-5560 (domestic) or 409-216-0605 (international) and refer to conference ID number 2127937. A replay of the webcast will be available for approximately 30 days.

About Omidubicel
Omidubicel (formerly known as NiCord), the company’s lead clinical program, is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies (blood cancers). Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration and has also received Orphan Drug Designation in the U.S. and EU. In a Phase 1/2 clinical study, omidubicel demonstrated rapid and durable time to engraftment and was generally well-tolerated.1 A Phase 3 study evaluating omidubicel in patients with leukemia and lymphoma is ongoing in the U.S., Europe and Asia.2 Omidubicel is also being evaluated in a Phase 1/2 clinical study in patients with severe aplastic anemia.3 The aplastic anemia investigational new drug application is currently filed with the FDA under the brand name CordIn, which is the same investigational development candidate as omidubicel. For more information on clinical trials of omidubicel, please visit www.clinicaltrials.gov.

About GDA-201
Gamida Cell applied the capabilities of its NAM-based cell expansion technology to develop GDA-201 (formerly known as NAM-NK), an innate natural killer (NK) cell immunotherapy for the treatment of hematologic and solid tumors in combination with standard of care antibody therapies. GDA-201 addresses key limitations of NK cells by increasing the cytotoxicity and in vivo retention and proliferation in the bone marrow and lymphoid organs of NK cells expanded in culture. GDA-201 is in Phase 1 development through an investigator-sponsored study in patients with refractory non-Hodgkin lymphoma and multiple myeloma.4

Omidubicel and GDA-201 are investigational therapies, and their safety and efficacy have not been evaluated by the U.S. Food and Drug Administration or any other health authority.

On August 6, 2019 Genprex, Inc. (NASDAQ: GNPX), a clinical-stage gene therapy company, reported that its manufacturing partner, Aldevron, has successfully completed the manufacturing of the TUSC2 (Tumor Suppressor Candidate 2) plasmid DNA pursuant to the manufacturing agreement between Genprex and Aldevron that was announced in September 2018 (Press release, Genprex, AUG 6, 2019, View Source [SID1234538218]).

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Genprex’s initial product candidate, Oncoprex consists of a TUSC2 plasmid DNA manufactured by Aldevron encapsulated in a nanovesicle made from lipid molecules with a positive electrical charge. Historically, the manufacturing steps of combining the plasmid DNA with the lipid nanovesicles of Oncoprex, has been done for Genprex at MD Anderson Cancer Center. Since Genprex’s IPO, the company has been working to transfer and scale up these processes through other contract manufacturers.

"Each successful release of plasmid DNA batches is an important milestone for Genprex as it allows us to not only demonstrate continued progress in coordinating scale-up manufacturing of Oncoprex, but it takes us one step closer to re-entering the clinic with both our EGFR program and our immunotherapy combination programs. Biologics manufacturing, especially for lipid nanoparticle (or LNP) delivered gene therapy, is a complex process, but one we tackle with pride alongside dedicated partners such as Aldevron, through a similar vision to deliver innovative therapies to patients with significant unmet medical needs," said Julien Pham, MD, Genprex’s President and Chief Operating Officer.

The U.S. Food and Drug Administration (FDA) has made manufacturing a top priority for cell and gene therapy companies. The FDA’s former Commissioner, Scott Gottlieb, noted in 2018 that the agency devotes approximately 80 percent of its focus during reviews of gene therapy candidates to manufacturing and quality concerns. FDA’s Director of the Center for Drug Evaluation and Research, Janet Woodcock, M.D., noted in July 2019 that the agency is adapting to the flood of new drug applications stemming from advances in gene therapy and is shifting its stance toward drug development more than in recent years. This shift emphasizes the need for gene therapy companies to not only demonstrate clinical efficacy but also be able to manufacture these drugs on a large scale.

Genprex has made manufacturing one of its top priorities since its IPO in 2018. During that time, Genprex has been building out its manufacturing process development to support this expansion and advance its commercial scaling capabilities.

Earlier this year, Genprex strengthened its senior team with the appointment of Eric Chapdelaine as Senior Director of Pharmaceutical Sciences and Manufacturing to support the company’s manufacturing, technical operations, and supply chain management.

On August 6, 2019 Seres Therapeutics, Inc. (Nasdaq: MCRB) reported second quarter 2019 financial results and provided business updates (Press release, Seres Therapeutics, AUG 6, 2019, https:// View Source [SID1234538217]).

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"We remain focused on the execution of our clinical programs and we look forward to a data-rich 2020 with four significant expected milestones including: SER-287 Phase 2b readout in mild-to-moderate ulcerative colitis; SER-109 Phase 3 readout in recurrent C. difficile infection; SER-401 Phase 1b readout in metastatic melanoma; and the advancement of our rationally-designed, fermented SER-301 program into clinical development for ulcerative colitis," said Eric D. Shaff, President and Chief Executive Officer at Seres. "We are also pleased to have strengthened Seres’ balance sheet through a public equity offering, giving us the resources needed to operate the Company into 2021 and to reach multiple important value inflection points," continued Mr. Shaff.

Program Updates and Corporate Highlights

SER-287 Phase 2b ECO-RESET study in ulcerative colitis: SER-287 is an oral, donor-derived microbiome therapeutic candidate designed to normalize the gastrointestinal microbiome of individuals with ulcerative colitis. Seres continues to enroll the SER-287 Phase 2b ECO-RESET induction study in patients with active mild-to-moderate ulcerative colitis. The SER-287 Phase 2b ECO-RESET study was initiated in December 2018 and is expected to enroll approximately 201 patients with mild-to-moderate ulcerative colitis. Based on FDA feedback, Seres expects that with positive Phase 2b study results, the study could serve as one of two pivotal trials to enable a SER-287 Biologics License Application (BLA) submission. Seres expects to report Phase 2b ECO-RESET study top line results in the third quarter of 2020.
SER-109 Phase 3 ECOSPOR III study in recurrent C. difficile infection: SER-109 is an oral, donor-derived microbiome therapeutic candidate designed to restore the depleted, or dysbiotic, gastrointestinal microbiome of patients with recurrent C. difficile infection. The Company continues to enroll the ECOSPOR III trial. ECOSPOR III is designed to evaluate efficacy and safety in 188 patients with recurrent C. difficile infection. All patients enrolled in ECOSPOR III are required to test positive for C. difficile cytotoxin to ensure enrollment of only patients with an active C. difficile infection. Seres expects to report SER-109 ECOSPOR III top line study results in early 2020.
SER-401 Phase 1b in metastatic melanoma: SER-401 is an oral, donor-derived microbiome therapeutic candidate comprising a bacterial signature similar to that observed in checkpoint inhibitor immunotherapy responders. The ongoing Phase 1b study, supported by the Parker Institute for Cancer Immunotherapy and The University of Texas MD Anderson Cancer Center, will evaluate the potential for SER-401 to augment response to nivolumab, an approved anti-PD-1 checkpoint inhibitor therapy, and will assess a variety of biological measures of response. Seres expects to obtain SER-401 Phase 1b preliminary study results in the second half of 2020.
SER-301 preclinical candidate: Seres also continues to advance its rationally-designed, fermented microbiome drug discovery and development capabilities. These efforts are focused on advancing SER-301, a preclinical therapeutic candidate for ulcerative colitis, into clinical development. The Company is entitled to a $10 million milestone payment associated with the initiation of SER-301 clinical development from its ongoing collaboration with Nestlé Health Science. Seres expects to file an Investigational New Drug (IND) application and initiate clinical development for SER-301 in early 2020.
Public equity offering (June 2019): Seres completed a public equity offering of common stock, resulting in net proceeds of $60.6 million. The financing involved both new and existing investors, including from a new fund managed by Flagship Pioneering.
Appointment of Stephen Berenson to its Board of Directors (August 2019): Mr. Berenson is a managing partner at Flagship Pioneering and previously spent his career as an investment banker at J.P. Morgan.
Financial Results
Seres reported a net loss of $10.8 million for the second quarter of 2019, as compared to a net loss of $27.8 million for the same period in 2018. The second quarter net loss was driven primarily by clinical and development expenses, personnel expenses and ongoing development of the Company’s microbiome therapeutics platform. The second quarter net loss figure was inclusive of $12.5 million in recognized revenue associated primarily with the Company’s collaborations with Nestlé Health Science and AstraZeneca.

Research and development expenses for the second quarter of 2019 were $17.9 million, as compared to $24.1 million for the same period in 2018. The research and development expense was primarily related to Seres’ microbiome therapeutics platform, the clinical development of SER-109 and SER-287, as well as the Company’s immuno-oncology efforts.

General and administrative expenses for the second quarter of 2019 were $5.6 million, as compared to $8.7 million for the same period in 2018. General and administrative expenses were primarily due to headcount, professional fees and facility costs.

Seres ended the second quarter with approximately $102.2 million in cash and cash equivalents that included the first of three $6.7 million annual installment payments due under the terms of the collaboration with AstraZeneca. In June 2019 the Company completed a public equity offering of common stock, resulting in net proceeds of $60.6M.

Cash use in the second quarter declined relative to prior periods as a result of the cost cutting corporate changes implemented earlier this year. Seres expects the lower expense levels incurred this quarter to be a proxy for subsequent quarters leading up to the clinical readouts expected in 2020. Based on the Company’s current operating plan, cash resources are expected to fund operating expenses and capital expenditure requirements, excluding net cash flows from future business development activities or potential incoming milestone payments, into the first quarter of 2021.

Conference Call Information
Seres’ management will host a conference call today, Aug. 6, 2019, at 8:00 a.m. ET. To access the conference call, please dial 844-277-9450 (domestic) or 336-525-7139 (international) and reference the conference ID number 7773387. To join the live webcast, please visit the "Investors and Media" section of the Seres website at www.serestherapeutics.com.

A webcast replay will be available on the Seres website beginning approximately two hours after the event and will be archived for at least 21 days.

On August 6, 2019 Ribon Therapeutics, a clinical stage biotechnology company, developing first-in-class therapeutics targeting novel enzyme families activated under cellular stress conditions, reported the appointments of Sudha Parasuraman, M.D., and Edward "Tad" Stewart to the newly created positions of Chief Medical Officer (CMO) and Chief Business Officer (CBO), respectively (Press release, Ribon Therapeutics, AUG 6, 2019, View Source [SID1234538216]). Dr. Parasuraman is a board-certified hematologist-oncologist with more than 20 years in the healthcare industry and broad experience across the spectrum of oncology drug development. Mr. Stewart brings more than 20 years of executive experience in the biotechnology area with a focus on business development, strategy and commercialization.

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"Sudha has had a distinguished career as a successful drug developer in the biopharmaceutical industry with expertise in leading clinical strategy, design and management of novel oncology programs, experience that aligns perfectly with our goal to bring first-in-class therapies to patients in need," said Victoria Richon, Ph.D., President and Chief Executive Officer, Ribon Therapeutics. "Tad brings to Ribon significant business development and strategy experience, perfectly suited to help us maximize the opportunities we see with our platform. On behalf of our entire team, I want to welcome both Sudha and Tad and we look forward to their contributions."

"Ribon has pioneered a completely novel area of human biology and rapidly used translational methods to bring those discoveries forward. Their lead program RBN-2397 is a testament to this approach and is now set to enter the clinic in the third quarter of this year," said Dr. Parasuraman. "This has established Ribon as the leader in developing potential first-in-class therapeutics that target stress response pathways. When activated, these enzymes are pivotal in disease progression and survival, making them very suitable for therapeutic intervention. I’m excited to join the Ribon team on their journey in bringing this exciting science to patients."

"Ribon’s platform enables thorough interrogation of stress response pathways, an expanding set of targets and rapid candidate generation," said Mr. Stewart. "Ribon has identified multiple monoPARP and NADase targets in oncology, neuro-degeneration and inflammatory diseases, and has tremendous capabilities to rapidly develop potent and selective inhibitors to target them. The speed with which the company has been able to execute on bringing their lead program toward the clinic is impressive and I look forward to helping expand the potential value of that platform for the company and for patients."

Dr. Parasuraman brings more than 20 years of industry and academic practice experience in hematology, oncology, and pediatrics to her work at Ribon. Most recently she served as CMO for X4 Pharmaceuticals, where she led their immuno-oncology and rare disease programs. Prior to X4, she was VP, Global Medical Affairs at uniQure Inc, where she built and led a team developing gene therapies for rare diseases. Prior to uniQure, she held senior positions at Novartis, where she led the early development program for the CDK4/6 inhibitor, ribociclib, and helped pave the way for accelerated registration studies. She was responsible for leading innovative clinical trials in the Signature Program and the commercial strategies for early-stage programs. Dr. Parasuraman also served as Medical Director at Millennium Pharmaceuticals (now Takeda Oncology) where she was the medical lead for various programs including the clinical development and lifecycle management of the first-in-class cancer therapy, VELCADE. Before joining industry, Dr. Parasuraman was a faculty member at Harvard Medical School and staff physician at Children’s Hospital of Boston, Dana Farber Cancer Institute, and Brigham and Women’s Hospital. Dr. Parasuraman completed her fellowship in pediatric hematology-oncology at St. Jude Children’s Research Hospital in Memphis, TN, and pediatric residencies at Children’s Hospital of Michigan and Los Angeles County/University of Southern California Medical Center. She received her medical degree from the University of Madras, India.

Mr. Stewart has more than 20 years of strategic biopharmaceutical business development experience, including over fifteen years at Merrimack Pharmaceuticals. During his time at Merrimack, Tad served in various roles as part of the executive leadership team, including leading the company’s business development efforts and heading the company’s Commercial Business Unit. Tad’s experience at Merrimack spanned its growth from a pre-clinical organization to a clinical development company and, ultimately, to a commercial enterprise, including the successful launch of a marketed oncology product (ONIVYDE) and the execution of several strategic transactions that supported the long-term growth of the company. Most recently he served as President and CEO of Commense, Inc., a company focused on developing pediatric immunomodulators based on manipulating the human microbiome. Prior to Commense, Tad served as CBO for Crescendo Biologics, a novel antibody platform company. Prior to Merrimack, Tad worked as a consultant with clients across the biotech, pharmaceutical and medical device industries. Tad holds an M.B.A. from the Johnson School at Cornell University and a B.S. in Biology from Bates College.

On August 6, 2019 Epizyme, Inc. (Nasdaq:EPZM), a late-stage biopharmaceutical company developing novel epigenetic therapies, reported that Robert Bazemore, president and chief executive officer, will present at the Wedbush PacGrow 2019 Healthcare Conference on Tuesday, Aug. 13, 2019 at 10:55 a.m. ET in New York City (Press release, Epizyme, AUG 6, 2019, View Source [SID1234538215]).

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A live webcast will be available in the investor section of the company’s website at www.epizyme.com. The webcast will be archived for 60 days following the presentation.