On December 1, 2020 Zai Lab Limited ("Zai Lab") (NASDAQ: ZLAB; HKEX: 9688), an innovative commercial-stage biopharmaceutical company, reported the appointment of Alan Sandler, M.D., to the newly created position of President, Head of Global Development, Oncology, where he will lead global oncology development and related enabling functions to support the Company’s development activities (Press release, Zai Laboratory, DEC 1, 2020, View Source [SID1234572071]). Dr. Sandler was most recently the Senior Vice President and Global Head of Product Development Oncology at Genentech, a member of the Roche Group. He will report to Dr. Samantha Du, Chief Executive Officer, and serve on the executive team.

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"We are delighted to welcome Alan to Zai Lab as we continue to expand globally and strengthen our R&D leadership," said Dr. Samantha Du, Founder, Chairwoman and CEO of Zai Lab. "Throughout his distinguished career, Alan has made significant contributions as a respected leader in the oncology community, both in industry and through his clinical practice and academic research. Alan has played a key role in the development of many innovative oncology therapies. We look forward to his leadership of our oncology franchise as we advance towards our goal of becoming a leading global biopharma company."

"I’m very excited to be joining Zai Lab, given its robust pipeline of innovative clinical compounds," said Dr. Sandler. "I look forward to accelerating the development of Zai’s extensive and differentiated pipeline of oncology compounds, guide them through regulatory review, and bring them as quickly as possible to patients in need in China and around the world. I am also excited about working to identify additional product candidates to further expand Zai’s oncology portfolio."

Dr. Sandler brings nearly 30 years of oncology and drug development experience across industry and academia. During his tenure at Genentech/Roche, he led the teams responsible for the global development and regulatory approval of several innovative medicines, most recently Tecentriq. Prior to joining Genentech/Roche, Dr. Sandler served as Professor and Chief of Hematology/Oncology at Oregon Health and Science University. Previously, he served on the faculties of the medical schools of Indiana University and Vanderbilt University. He holds a Doctor of Medicine degree from Rush Medical College. Dr. Sandler completed his training in internal medicine and a fellowship in medical oncology at Yale-New Haven Medical Center. He has published over 300 peer-reviewed publications, articles, abstracts and book chapters.

On December 1, 2020 Step Pharma SAS, in collaboration with Sygnature Discovery, reported that it has been selected to present a poster named "STP938, a Novel, Potent and Selective Inhibitor of CTP Synthase 1 (CTPS1) Is a Targeted Therapy Specifically Blocking De Novo Nucleotide Synthesis in Lymphomas and Leukemias" at the American Society of Hematology (ASH) (Free ASH Whitepaper) conference starting December 5th (Press release, Step Pharma, DEC 1, 2020, View Source [SID1234572070]).

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On December 1, 2020 Dana-Farber Cancer Institute researchers reported that it will present more than 40 research studies at the virtual 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting on December 5-8, including two studies that were selected for inclusion in the official press program (Press release, Dana-Farber Cancer Institute, DEC 1, 2020, View Source [SID1234572069]). Dana-Farber is home to one of the largest and most respected treatment centers for patients with disorders of the blood and bone marrow. ASH (Free ASH Whitepaper) is the world’s most comprehensive hematology event, attracting more than 25,000 hematology professionals from around the world.

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Scientific updates to be presented at ASH (Free ASH Whitepaper) reveal potentially practice changing findings related to stem cell transplant, lymphoma, leukemia, and multiple myeloma treatment. Notable oral presentations by Dana-Farber researchers include:

Title: A multi-center biologic assignment trial comparing reduced intensity allogeneic hematopoietic cell transplantation to hypomethylating therapy or best supportive care in patients aged 50-75 with advanced myelodysplastic syndrome: Blood and marrow transplant clinical trials network study 1102*

Abstract: 75

Presenter: Corey Cutler, MD, MPH, FRCPC

Press Program Time: Friday, Dec. 4, 9:30 a.m. PST / 12:30 p.m. EST

Session Time: Saturday, Dec. 5, 7:30 a.m. PST / 10:30 a.m. EST

Recent advances in the treatment of myelodysplastic syndrome (MDS) have improved patient survival and quality of life, while reducing transfusion burden. However, allogeneic hematopoietic cell transplantation (HCT), widely used in younger MDS patients, remains the only curative therapy for MDS. While transplantation outcomes among selected older patients with MDS are similar to younger patients with MDS, early transplantation for older patients is infrequently offered since the relative benefits of HCT over non-HCT therapy have not been well defined in this patient group. This multi-center, biologic assignment trial in older individuals with high risk MDS defines the benefit of HCT over non-HCT therapy.

Title: DNMT3A clonal hematopoiesis in older donors is associated with improved survival in recipients after allogeneic hematopoietic cell transplant

Abstract: 80

Presenter: Christopher Gibson, MD

Session Time: Saturday, Dec. 5, 8:45 a.m. PST / 11:45 a.m. EST

Clonal hematopoiesis (CH) is an age-related condition in which somatic mutations can be detected in the blood of healthy individuals. In the non-transplant setting, CH is associated with an elevated risk of developing hematologic malignancy and an increased risk of non-hematologic outcomes due to altered inflammatory signaling. During hematopoietic cell transplantation (HCT), CH in older donors can engraft in recipients and could therefore influence outcomes through effects on graft immunologic function or by causing donor cell leukemia. A definitive link between donor CH and recipient outcomes has not been established. Dana-Farber researchers evaluated the impact of CH in donors aged 40 years or older on recipient clinical outcomes in 1,727 donor-recipient pairs.

Title: Safety and efficacy of adding venetoclax to reduced intensity conditioning chemotherapy prior to allogeneic hematopoietic cell transplantation in patients with high risk myeloid malignancies

Abstract: 190

Presenter: Jacqueline S. Garcia, MD

Session Time: Saturday, Dec. 5, 12:15 p.m. PST / 3:15 p.m. EST

The outcomes for patients with myeloid malignancies who relapse after allogeneic hematopoietic cell transplantation (HCT) is poor, and relapse occurs more frequently for those with high-risk mutations or cytogenetics. The oral selective BCL-2 inhibitor and BH3 mimetic venetoclax increases mitochondrial apoptotic priming, even in chemoresistant myeloblasts. Reasoning that venetoclax would selectively increase the anti-leukemic effect of HCT conditioning chemotherapy without undue toxicity, this study evaluated the safety and efficacy of adding venetoclax to fludarabine and busulfan reduced intensity conditioning chemotherapy. Dana-Farber researchers report on the completed dose-escalation and expansion cohorts from the phase 1 trial.

Title: Prognostic value of circulating tumor DNA (ctDNA) in autologous stem cell graft and post-transplant plasma samples among patients with diffuse large B-Cell lymphoma

Abstract: 531

Presenter: Reid Merryman, MD

Session Time: Monday, Dec. 7, 7:15 a.m. PST / 10:15 a.m. EST

While autologous stem cell transplantation (ASCT) can be curative for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), relapse remains common. With the emergence of novel effective therapies, it is even more important to identify patients at high risk of treatment failure who may not benefit from ASCT, and patients with impending post-ASCT relapse who may be candidates for pre-emptive interventions. Researchers assembled cohorts of DLBCL patients who underwent ASCT and had apheresis stem cell samples or serially collected post-ASCT peripheral blood mononuclear cell and plasma samples. Researchers hypothesized that circulating tumor DNA identified using immunoglobulin-based next generation sequencing in apheresis stem cell or peripheral blood samples could predict relapse.

Title: Safety, Efficacy, and patient-reported outcomes of venetoclax in combination with azacitidine for the treatment of patients with higher-risk myelodysplastic syndrome: A phase 1b study

Abstract: 656

Presenter: Jacqueline S. Garcia, MD

Session Time: Monday, Dec.7, 12:15 p.m. PST / 3:15 p.m. EST

Hypomethylating agents form the current standard treatment for patients with higher-risk myelodysplastic syndrome who are not eligible for allogeneic hematopoietic stem cell transplantation (HSCT). However, overall response rates remain low in patients receiving azacitidine, and median overall survival is reported as ~15 months. In addition, there are few data on patient-reported outcomes published in this population while on treatment. Venetoclax is a selective, potent, orally bioavailable BCL-2 inhibitor, which has demonstrated synergy with hypomethylating agents in preclinical studies of higher-risk myelodysplastic syndrome. From an ongoing, open-label, dose-escalation, Phase 1b study evaluating venetoclax and azacitidine for the treatment of treatment-naïve higher-risk MDS, researchers report the updated safety and efficacy in all treated patients and the exploratory analysis of key patient-reported outcomes in patients who received the recommended Phase 2 dose (RP2D).

Title: Primary analysis of ZUMA-5: A phase 2 study of axicabtagene ciloleucel (axi-cel) in patients with relapsed/refractory (R/R) indolent non-Hodgkin lymphoma (iNHL)*

Abstract: 700

Presenter: Caron Jacobson, MD, MMSc

Press Program Time: Saturday, Dec. 5, 9:30 a.m. PST / 12:30 p.m. EST

Session Time: Monday, Dec. 7, 1:30 p.m. PST / 4:30 p.m. EST

Patients with advanced-stage indolent non-Hodgkin lymphoma, including follicular lymphoma and marginal zone lymphoma, frequently relapse with standard treatment, underscoring a need for novel therapies. Axi-cel autologous anti-CD19 chimeric antigen receptor (CAR) T cell therapy is approved for the treatment of relapsed/refractory large B cell lymphoma after more than two lines of systemic therapy. Dana-Farber will present the primary analysis of ZUMA-5, a Phase 2, multicenter, single-arm study of axi-cel in patients with relapsed/refractory indolent non-Hodgkin lymphoma.

On December 1, 2020 CollPlant (NASDAQ: CLGN), a regenerative and aesthetics medicine company, reported financial results for the third quarter ended September 30, 2020 and provided an update on the Company’s business developments (Press release, CollPlant, DEC 1, 2020, View Source [SID1234572068]). Certain metrics, including those expressed on an adjusted basis, are non-GAAP measures. See "Use of Non-GAAP Measures" below.

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CollPlant reported revenues of $4.1 million for the third quarter of 2020, a 511% increase from the $679,000 recorded in the third quarter of 2019. The Company ended the third quarter of 2020 with $5.0 million in cash and cash equivalents. Comprehensive income for the third quarter of 2020 was $703,000 on a GAAP basis, or adjusted comprehensive income of $1.1 million, on a non-GAAP basis.

"We are very pleased with the progress of our collaboration with United Therapeutics which started with lungs and is now expanding to cover kidneys, a second lifesaving organ. The $3 million payment for the option exercise which contributed to our profitability in the third quarter of 2020 is part of a larger agreement signed in October 2018 that includes upfront and milestone payments plus royalties," stated Yehiel Tal, CollPlant’s Chief Executive Officer.

"We continue to advance our medical aesthetics line with next-generation, regenerative, photocurable dermal fillers which we believe will yield skin rejuvenation inclusive of the ability to inject into deep wrinkles, as well as other key attributes. During the third quarter of 2020 we shared updates on our photocurable dermal fillers and on our breast implant product pipeline, at the exclusive Science of Aging Virtual Symposium 2020."

"Furthermore, we are moving forward with a development program of an antiviral agent for the potential treatment of COVID-19. We got promising preclinical data showing our platform technology significantly inhibited avian coronavirus infectivity. The data indicated our formulation that is comprised of rhCollagen imbedded with silver nanoparticles (AgNP), targets viral load in COVID-19 patients, thereby potentially assisting the body’s immune system to combat viral infection, reduce transmission rates between people, and ultimately reduce the percentage of patients who need to be treated in critical care settings," Mr. Tal concluded.

Financial Results

Third Quarter 2020 Financial Results on U.S. GAAP basis ("GAAP")

Revenues for the three months ended September 30, 2020 increased by 511% to $4.1 million, compared to $679,000 in the third quarter of 2019. Revenues were derived mainly from sales of CollPlant’s BioInk for the development of 3D bioprinting of human organs, the exercise of an option by United Therapeutics for licensing CollPlant technology to print kidneys, and from sales of rhCollagen for medical aesthetics product development.

Cost of revenue was $1.4 million in the three months ended September 30, 2020, an increase of 123% compared to $645,000 in the same period in 2019. The increase is primarily related to royalties payments to the Israel Innovation Authority on revenue from licensing CollPlant’s technology to United Therapeutics for printing of kidneys.

The Company’s gross profit for the three months ended September 30, 2020 increased by $2.7 million to $2.7 million, or 65% of revenues, in the third quarter of 2020, compared to $34,000, or 5% of revenues in the third quarter of 2019.

Total operating expenses for the three months ended September 30, 2020 were $2.0 million, an increase of 11% compared to $1.8 million in the third quarter of 2019. The increase is primarily related to share-based compensation expenses for options grant.

Operating profit for the three months ended September 30, 2020 was $734,000, compared to an operating loss of $1.7 million in the third quarter of 2019.

Financial expense, net for the three months ended September 30, 2020 was $31,000 compared to $1.4 million in the third quarter of 2019. Financial expense in the three months ended September 30, 2020 and September 30, 2019 mainly derived from non-cash exchange differences of operating lease liabilities under ASC 842, and re-evaluation of financial instruments.

Comprehensive income for the third quarter of 2020 was $703,000, or $0.10 per share, compared to a comprehensive loss of $3.2 million, or $0.68 per share, for the third quarter of 2019.

Cash used in operating activities during the nine months ended September 30, 2020 was $2.9 million compared to $4.1 million in the nine months ended September 30, 2019. As of September 30, 2020, cash and cash equivalents totaled $5.0 million.

Cash used in investing activities during the nine months ended September 30, 2020 was $378,000 compared to $1.2 million in the nine months ended September 30, 2019. The decrease is mainly attributable to costs incurred in the establishment in 2019 of CollPlant’s new HQ and R&D center in Rehovot, Israel.

Cash provided by financing activities during the nine months ended September 30, 2020 was $4.5 million, of which $4.4 million are attributable to proceeds from issuance of shares in a private placement in February 2020. Cash provided in the nine months ended September 30, 2019 by financing activities amounted to $5.4 million, and are attributed to proceeds from funding in September 2019.

Third Quarter 2020 Financial Results on Non-U.S. GAAP Basis ("non-GAAP")

On a non-GAAP basis, the operating expenses for the third quarter of 2020 were $1.6 million, a decrease of $106,000 compared to $1.7 million for the third quarter of 2019.

Comprehensive income for the third quarter of 2020 was $1.1 million, or $0.16 per share, compared to comprehensive loss of $1.8 million, or $0.38 per share, for the third quarter of 2019.

Non-GAAP measures exclude certain non-cash expenses. The table on page 10 includes a reconciliation of the Company’s GAAP results to non-GAAP results. The reconciliation reflects non-cash expenses in the amount of $397,000 with respect to (i) change in fair value of financial instruments, (ii) share-based compensation to employees, directors and consultants and (iii) change of operating lease accounts, including related financial expenses.

Use of Non-GAAP Measures

This press release contains certain non-GAAP financial measures for operating costs and expenses, operating loss, comprehensive loss and basic and diluted comprehensive loss per share that exclude the effects of non-cash expense for fair market value attributed to change in fair value of financial instruments, share-based compensation to employees, directors and consultants, and change in operating lease accounts. Management believes that these non-GAAP financial measures provide meaningful supplemental information regarding the Company’s performance that enhances management’s and investors’ ability to evaluate the Company’s operating costs, comprehensive loss and loss per share, and to compare them to historical Company results.

The presentation of this non-GAAP financial information is not intended to be considered in isolation or as a substitute for the financial information prepared and presented in accordance with GAAP. Management uses both GAAP and non-GAAP measures when operating and evaluating the Company’s business internally and therefore decided to make these non-GAAP adjustments available to investors. The non-GAAP financial measures used by the Company in this press release may be different from the measures used by other companies.

For more information on the non-GAAP financial measures, please see the "Reconciliation of GAAP to Non-GAAP Financial Measures" table on page 10 in this press release. This accompanying table on page 10 has more details on the GAAP financial measures that are most directly comparable to non-GAAP financial measures and the related reconciliations between these financial measures.

The Company’s consolidated financial results as of, and for the nine months ended, September 30, 2020 are presented in accordance with generally accepted accounting principles in the United States of America ("U.S. GAAP").

On December 1, 2020 Sierra Oncology, Inc. (SRRA), a late-stage biopharmaceutical company on a quest to deliver targeted therapies that treat rare forms of cancer, reported it will host an analyst and investor event on Wednesday, December 16, 2020 at 10:00 am ET (Press release, Sierra Oncology, DEC 1, 2020, View Source [SID1234572067]). The event will feature three leading myelofibrosis experts:

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Jean-Jacques Kiladjian, MD, PhD, Saint-Louis Hospital; Paris Diderot University
Ruben Mesa, MD, Director of the Mays Cancer Center, home to UT Health San Antonio, MD Anderson Cancer Center
Srdan Verstovsek, MD, PhD, University of Texas; MD Anderson Cancer Center
The call will include an overview of momelotinib data presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, a panel discussion moderated by Barbara Klencke, MD, Chief Development Officer of Sierra Oncology, and an open question & answer session with attendees.

Analyst & Investor Event and Webcast Information

Date and Time: Wednesday, December 16, 2020, 10:00 am ET

To register, please click here.

The presentation will be webcast live, and an archive of the presentation will be accessible after the event through the Sierra Oncology website: www.SierraOncology.com.

About Momelotinib

Momelotinib is a selective and orally bioavailable JAK1, JAK2 and ACVR1 inhibitor currently under investigation for the treatment of myelofibrosis. Myelofibrosis results from dysregulated JAK-STAT signaling and is driven by constitutional symptoms, splenomegaly (enlarged spleen) and progressive anemia.

Momelotinib is currently under investigation in the MOMENTUM clinical trial, a global, randomized, double-blind Phase 3 study for symptomatic and anemic myelofibrosis patients. Top-line data are anticipated in H1 2022. The U.S. Food & Drug Administration has granted Fast Track designation for momelotinib.