On August 30, 2018 Zai Lab Limited ("Zai Lab" or the "Company") (NASDAQ:ZLAB), a Shanghai-based innovative biopharmaceutical company, reported financial results for the six months ended June 30, 2018, and provided a corporate update (Press release, Zai Laboratory, AUG 30, 2018, View Source [SID1234529211]).

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"The first half of 2018 has been a period of tremendous progress for Zai Lab, marked by the continued advancement of our clinical programs, expansion of our therapeutic pipeline, preparation for our commercial launch and strengthening of our management team," said Dr. Samantha Du, Zai Lab’s Chief Executive Officer. "For ZL-2306 (niraparib), we continue to enroll patients in three separate pivotal trials in China targeting ovarian and small cell lung cancer, and are exploring additional indications by planning to initiate several more trials in the remainder of the year. The goal of our comprehensive clinical development program is to establish ZL-2306 (niraparib) as the leading PARP inhibitor in China. In addition, we continue to advance our multiple late-stage clinical programs in both oncology and infectious diseases. The past six months also marked the exciting transition of Zai Lab to a commercial stage company. In anticipation of the launch of ZL-2306 (niraparib) in Hong Kong later this year and in China, we started building our sales and marketing team, and importantly, appointed industry veteran William Liang as Chief Commercial Officer. In addition, we appointed Yong-Jiang Hei, M.D., Ph.D., as our Chief Medical Officer (CMO) for oncology to lead and advance our oncology pipeline. As we approach our upcoming clinical and commercial milestones throughout the remainder of 2018, we believe that Zai Lab is well-positioned to continue our positive momentum."

Recent Clinical Highlights

ZL-2306 (niraparib)

In August 2018, Zai Lab announced the early completion of an open-label study to evaluate the pharmacokinetic (PK) profile of ZL-2306 (niraparib) made in China in Chinese ovarian cancer patients. The study demonstrated a comparable PK profile of Chinese patients who were administered ZL-2306 to the PK profile of patients evaluated in Tesaro’s clinical trials using product manufactured outside of China. These results support the regulatory review of ZL-2306 (niraparib) in China.

In August 2018, Zai Lab enrolled the first patient in its Phase III registration trial of ZL-2306 (niraparib) as a first-line maintenance therapy in small cell lung cancer (SCLC) in China. This will be the first clinical trial of ZL-2306 (niraparib) in this type of cancer.

In June 2018, Zai Lab dosed the first patient in its Phase III China registration trial of ZL-2306 (niraparib) for first-line maintenance therapy of patients with platinum-responsive ovarian cancer.

FPA144 (bemarituzumab)

In May 2018, Zai Lab received clinical trial application (CTA) approval from China’s National Drug Administration (CNDA) to enroll Chinese patients in the Phase I/III FIGHT (FGFR2b Inhibition in Gastric and Gastroesophageal Junction Cancer Treatment) global registrational trial, evaluating FPA144 (bemarituzumab) in combination with a modified FOLFOX chemotherapy regimen. Zai Lab received CTA approval three months ahead of schedule.

ZL-2401 (omadacycline)

In April 2018, Zai Lab’s bridging approach leveraging the Phase III ZL-2401 (omadacycline) studies conducted abroad was accepted by China’s Center for Drug Evaluation (CDE). An agreement was reached with CDE for the Company’s proposal to conduct a truncated clinical program for approval in China. Zai Lab obtained CTA approval from CNDA within three and a half months of submitting its application and is ready to implement the requested China studies in the fourth quarter of 2018.

ZL-3101 (Fugan)

In August 2018, results of a Phase II study evaluating ZL-3101 (Fugan), a natural product in patients with mild to moderate atopic dermatitis, received four months ahead of schedule, showed ZL-3101 was safe and well-tolerated, but did not show signs of efficacy over placebo. The Company elected to discontinue further development of ZL-3101 (Fugan) based on these findings and shift related resources to other programs.

Recent Business & Corporate Developments

In August 2018, Zai Lab appointed Yong-Jiang Hei, M.D., Ph.D., as its CMO, Oncology. Dr. Hei is a seasoned industry expert with over 20 years of experience in clinical development in oncology and will support the strategic development and expansion of the Company’s growing oncology clinical pipeline. Most notably, he served at Amgen, Inc. for approximately 10 years in multiple roles of increasing responsibility in oncology global development. Dr. Qi Liu will transition to an advisory role.

In August 2018, Zai Lab appointed Kai-Xian Chen, Ph.D., to its Board of Directors. Professor Chen is a globally recognized scientist and widely regarded as a pioneer in the field of interdisciplinary healthcare research. In connection with Professor Chen’s appointment, Marietta Wu, Ph.D. retired from the Board of Directors.

In June 2018, Zai Lab appointed William Liang as Chief Commercial Officer. William brings more than two decades of experience in the pharmaceutical industry, with expertise in commercial launch, strategy and operations. Prior to joining Zai Lab, William served as Vice President at AstraZeneca heading up the Oncology Business Unit in China.

In June 2018, Zai Lab completed construction of a biologics pilot facility using GE Healthcare’s Flex Factory platform technology. The facility is capable of supporting biologics drug products for clinical and non-clinical development of Zai Lab’s drug candidates.

In May 2018, Zai Lab entered into an exclusive worldwide agreement with Crescendo Biologics for ZL-1102, a topical, innovative antibody for potential application in inflammatory indications, including psoriasis.

In April 2018, Zai Lab entered into an exclusive license agreement in Asia-Pacific, and a global development agreement, with Entasis Therapeutics (Entasis) for ETX2514, a novel broad-spectrum intravenous inhibitor of ß-lactamases, for the treatment of a variety of serious multidrug-resistant (MDR) infections. In combination with sulbactam, ETX2514 is particularly active against MDR Acinetobacter baumannii infections.

Zai Lab continues to expand its platform and human resources. As of June 30, 2018, Zai Lab employed 182 full-time employees, including 37 employees with M.D. or Ph.D. degrees. Currently, approximately 85% of the Company’s employees are engaged in R&D activities. Employee mix is projected to change as the Company continues to build out its commercial team.

Zai Lab has, from time to time, evaluated partnership opportunities and may, in the future, make acquisitions of, or investments in, companies that Zai Lab believes have products or capabilities that are a strategic or commercial fit with Zai Lab’s current drug candidates and business or otherwise offer opportunities for the Company.

Upcoming Milestones

ZL-2306 (niraparib)

On September 23, 2018, the design of the Phase III study of ZL-2306 (niraparib) as maintenance therapy in first line platinum-responsive small cell lung cancer (SCLC) patients will be presented at the International Association for the Study of Lung Cancer (IASLC) 19th World Conference on Lung Cancer (WCLC).

On September 21, 2018, results from a Phase I PK and safety study of ZL-2306 (niraparib) in Chinese patients with epithelial ovarian cancer (OC) will be presented at the 21st Annual Meeting of Chinese Society of Clinical Oncology (CSCO).

Zai Lab plans to begin commercializing ZL-2306 (niraparib) as a second-line maintenance therapy in patients with recurrent platinum-sensitive ovarian cancer in Hong Kong during the fourth quarter of 2018, and in Macau thereafter.

ZL-2401 (omadacycline)

Zai Lab expects to initiate a bioequivalence and PK bridging study in China to demonstrate comparability in the PK profile of Chinese patients administered with ZL-2401 (omadacycline) to non-Chinese patients, in preparation for its New Drug Application (NDA) submission in China. This program is expected to start in the fourth quarter of 2018.

Paratek Pharmaceuticals has a Prescription Drug User Fee Act (PDUFA) action date set in October 2018 for its NDA for once-daily oral and intravenous formulations of omadacycline for the treatment of community-acquired bacterial pneumonia (CABP) and acute skin and skin structure infections (ABSSSI). On August 8, 2018, Antimicrobials Drug Advisory Committee of the U.S. FDA voted in favor of the approval of IV and oral omadacycline.

FPA 144 (bemarituzumab)

In collaboration with Five Prime, Zai Lab plans to initiate patient dosing in the China portion of the randomized, controlled Phase III portion of the Phase I/III FIGHT global registration trial in the fourth quarter of 2018.

ETX2514

In collaboration with Entasis, Zai Lab plans to initiate patient dosing in the Asia-Pacific portion of the Phase III global registration trial of ETX2514 for MDR Acinetobacter pneumonia and bloodstream infections in 2019.

ZL-2301 (brivanib)

Data from a Phase II trial of ZL-2301 (brivanib) as a second-line treatment for advanced hepatocellular cancer patients in China are expected in the second half of 2018.

On September 22, 2018, preliminary study results from the Phase II trial of ZL-2301 (brivanib) in advanced HCC patients with systemic treatment failure or intolerance will be presented at the 21st Annual Meeting of Chinese Society of Clinical Oncology (CSCO).

ZL-2302

In the fourth quarter of 2018, Zai Lab plans to initiate Phase I clinical trials in China of ZL-2302 for the treatment of patients with non-small cell lung cancer (NSCLC) who have ALK mutations and developed crizotinib resistance and/or brain metastasis.

Financial Results for the Six Months Ended June 30, 2018

As of June 30, 2018, cash and cash equivalents and short-term investments totaled $177.7 million.

Research and development expenses were $34.6 million for the six months ended June 30, 2018 compared to $20.9 million for the same period in 2017. The increase was primarily due to higher clinical and preclinical costs from the advancement of the Company’s expanded pipeline, and expansion of research efforts to support internal programs.

General and administrative expenses were $6.4 million for the six months ended June 30, 2018 compared to $4.0 million for the same period in 2017. The increase was primarily due to the increase in payroll and payroll-related expenses as a result of the increased headcount from expanded operations, and increased costs associated with operating as a public company.

For the six months ended June 30, 2018, Zai Lab reported a net loss of $41.5 million, or basic and diluted net loss per share attributable to common stockholders of $0.83, compared to a net loss of $24.4 million, or basic and diluted net loss per share attributable to common stockholders of $2.30, for the same period in 2017.

On August 30, 2018 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, reported that Shalini Sharp, the Company’s Chief Financial Officer, will present at the following upcoming investor conferences (Press release, Ultragenyx Pharmaceutical, AUG 30, 2018, View Source [SID1234529336]):

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Baird Global Healthcare Conference on Thursday, September 6, 2018 at 10:15am ET in New York.
Morgan Stanley Global Healthcare Conference on Thursday, September 13, 2018 at 4:40pm ET in New York.
The live and archived webcast of the Company presentations will be accessible from the Company’s website at View Source The replay of the webcast will be available for 90 days.

On August 30, 2018 Replimune Group Inc. (NASDAQ: REPL), a biotechnology company developing oncolytic immunotherapies derived from its Immulytic platform, reported financial results for its first fiscal quarter ended June 30, 2018, and provided an update on its business (Press release, Replimune, AUG 30, 2018, View Source [SID1234529395]).

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"With the completion of our successful initial public offering, Replimune is well funded to advance our new generation of oncolytic immunotherapy product candidates derived from our Immulytic platform through clinical trials in multiple tumor types and to establish in-house manufacturing capabilities," said Robert Coffin, Ph.D., co-founder and CEO of Replimune. "We are pleased with the preparations underway to initiate clinical studies under our collaboration agreements with Bristol-Myers Squibb, entered in February, for the development of RPI in combination with the anti-PD-1 antibody nivolumab, and with Regeneron, entered in May, for the development of RP1 in combination with the anti-PD1 antibody cemiplimab. We were also pleased to enter an agreement for the lease of a manufacturing site in Framingham, MA where we intend to produce supplies for later-stage clinical development and ultimate commercialization of our product candidates."

Recent Business Highlights

·The investigational new drug (IND) application for RP1 submitted with the U.S. Food and Drug Administration (FDA) is progressing on track. Replimune submitted an amendment to the IND in early August to include the longer-term toxicology data previously requested by the FDA and expects to receive acceptance of the IND in the U.S. in the coming months. Replimune’s Phase 1/2 clinical trial with RP1 is currently ongoing in the United Kingdom, and Replimune plans to open the clinical trial in the U.S. later in the year. The first part of the clinical trial is testing RP1 initially alone and then in combination with nivolumab for safety and biological activity in patients with advanced, heavily pre-treated solid tumors, and the second part of the clinical trial will test RP1 in combination with nivolumab in approximately 120 patients with metastatic melanoma, metastatic bladder cancer, microsatelite instability high cancer, and non-melanoma skin cancers, under Replimune’s collaboration agreement with Bristol-Myers Squibb (BMS).

· Entered into a strategic collaboration with Regeneron Pharmaceuticals. In May, Replimune entered into an open-ended agreement with Regeneron that allows for clinical development of Replimune’s Immulytic product candidates in combination with Regeneron’s cemiplimab (REGN2810), an investigational PD-1 antibody, on a 50/50 cost sharing basis. The first clinical trial under this agreement is intended to be a randomized, controlled Phase

2 clinical trial of RP1 combined with cemiplimab compared to cemiplimab alone in cutaneous squamous cell carcinoma (CSCC). CSCC is the highest mortality skin cancer after melanoma, and while no drugs are currently FDA-approved for its treatment, cemiplimab has been filed with the FDA for approval based on encouraging data with cemiplimab in this disease.

·Entered into a collaboration with BMS. In February, Replimune entered into a collaboration agreement with Bristol-Myers Squibb under which BMS will provide to Replimune, at no cost, nivolumab, its anti-PD-1 therapy, for use in combination with RP1 in the ongoing Phase 1/2 clinical trial.

·Signed an agreement for the lease of a manufacturing facility to support late-stage development and commercialization. Replimune signed an agreement in June for the lease of a 63,000-square-foot facility in Framingham, MA where the Company intends to establish world-class, multi-product manufacturing capabilities for its Immulytic product candidates. The facility is expected to be operational in the first half of 2020.

·Continued to build a strong leadership team. In June, Replimune appointed Dieter Weinand and Hyam Levitsky to the Board of Directors. Mr. Weinand is the current President of Bayer Pharmaceuticals and serves on the board of Bayer AG. Dr. Levitsky is a pioneer in immuno-oncology research with expertise in multiple areas including adoptive T cell therapies, cancer vaccines, and immunomodulatory therapies for the treatment of hematologic malignances and solid tumors, and most recently served as Chief Scientific Officer of Juno Therapeutics prior to its acquisition by Celgene Inc.

·Successfully completed an Initial Public Offering (IPO). In July, the Company completed its IPO, raising approximately $111 million in gross proceeds, before underwriting discounts and commissions and other offering expenses. Replimune intends to use the net proceeds to fund the development of multiple product candidates derived from its Immulytic platform into and through clinical trials, fund the fit-out and commissioning of its manufacturing facility, and general corporate expenses.

Guidance on Upcoming Events

· RP1 — In the second half of calendar 2018, define the dose of RP1 intended for future use and initiate dosing of RP1 combined with nivolumab in a cohort of 12 advanced cancer patients with a range of solid tumors, in the second part of the Phase 1 stage of the ongoing Phase 1/2 study.

· RP1 — In the first half of 2019, initiate dosing of approximately 120 patients with RP1 in combination with nivolumab, in four defined indications: metastatic melanoma, metastatic bladder cancer, microsatelite instability high cancer, and non-melanoma skin cancers.

· RP1 — In the first half of 2019, initiate a randomized, controlled Phase 2 clinical trial of RP1 in combination with cemiplimab, compared to cemiplimab alone, in approximately 240 patients with CSCC.

· RP2 — In the first half of 2019, file an IND with the FDA and/or a CTA with the MHRA in the United Kingdom. RP2 is a version of RP1 that, in addition to expressing a fusogenic protein and GM-CSF, also expresses a genetically encoded anti-CTLA-4 antibody.

· In the second half of calendar 2018, finalize the RP3 product candidate to be progressed into clinical trials. RP3 is intended to additionally express immune co-stimulatory pathway

activating ligands, with the goal of activating immune co-stimulatory pathways, in addition to blocking immune co-inhibition through CTLA-4.

Financial Highlights

Replimune reported a net loss of $10.0 million for the quarter ended June 30, 2018 compared with $3.6 million for same period in the prior year. The increase in net loss for the year was due to increased research and development expenses, change in fair value of warrant liability, as well as expenses related to Replimune’s IPO.

Research and development expenses for the quarter ended June 30, 2018 were $3.9 million compared with $2.3 million for same period in the prior year. The increase in research and development expenses was primarily driven by additional costs related to Replimune’s preclinical and clinical development activities for its pipeline, as well as increased salary and related benefits costs due to the increase in employee headcount from 28 on June 30, 2017 to 36 on June 30, 2018.

General and administrative expenses were $1.9 million for the quarter ended June 30, 2018 compared with $0.9 million for same period in the prior year. The increase in general and administrative expenses was primarily due to an increase in legal and accounting fees related to the Company’s IPO, the increase in employee headcount and the impact of stock-based compensation in 2018.

Replimune ended the quarter with $52.0 million in cash, cash equivalents and short-term investments, compared with $61.6 million as of March 31, 2018. The decrease reflected continuing expenses in the ordinary course, along with a transfer of $1.8 million to restricted cash in connection with the signing of a lease for our manufacturing facility in Framingham, MA. Following the end of the first quarter, the Company received net proceeds of $103.3 million in connection with its IPO.

Based on its current operating plan, Replimune expects that its current cash, cash equivalents and short-term investments will enable it to fund its operating expenses and capital expenditure requirements into the second half of 2021.

On August 30, 2018 Idera Pharmaceuticals, Inc. (NASDAQ: IDRA), a pharmaceutical company focused on the development and commercialization of its proprietary immune modulator, tilsotolimod, for the treatment of cancer, reported that the company will participate in the H.C. Wainwright 20th Annual Global Investment Conference on Wednesday, September 5, 2018 at 2:10 p.m. Eastern Time at the St. Regis Hotel in New York City (Press release, Idera Pharmaceuticals, AUG 30, 2018, View Source [SID1234529172]).

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Live audio webcast of Idera’s presentations will be accessible in the Investors and Media section of Idera’s website at View Source Archived versions will also be available on the Company’s website after the event for 90 days.

On August 30, 2018 Diplomat Pharmacy, Inc. (NYSE: DPLO), reported that executives will present at three upcoming investor conferences (Press release, Diplomat Speciality Pharmacy, AUG 30, 2018, View Source [SID1234529191]).

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Baird Global Healthcare Conference in New York: Atul Kavthekar, chief financial officer, will present at 9:40 a.m. ET. Sept. 5.

Wells Fargo Securities Healthcare Conference in Boston: Brian Griffin, chairman and chief executive officer, and Atul Kavthekar, chief financial officer, will present at 8 a.m. ET. Sept. 6.

Morgan Stanley Global Healthcare Conference in New York: Brian Griffin, chairman and CEO; Joel Saban, president; and Atul Kavthekar, chief financial officer, will present at 11:40 a.m. ET. Sept. 12.

Live audio webcasts of each presentation will be available on the investor relations section of Diplomat’s website at ir.diplomat.is. Recordings will be available for approximately 90 days following each presentation at the same URL.