On November 12, 2018 UroGen Pharma Ltd. (Nasdaq:URGN), a clinical-stage biopharmaceutical company developing treatments to address unmet needs in the field of urology, with a focus on uro-oncology, reported financial results for third quarter ended September 30, 2018 and that it has completed enrollment of the UGN-101 OLYMPUS Phase 3 Trial in patients with low-grade upper tract urothelial cancer (LG UTUC) following a recent pre-New Drug Application (NDA) meeting held with the U.S. Food and Drug Administration (FDA) (Press release, UroGen Pharma, NOV 12, 2018, View Source [SID1234531211]).

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At the pre-NDA meeting, the company presented updated data from this open-label, single arm Phase 3 study. The meeting resulted in agreement on the required information for the NDA submission and suitability for NDA submission of primary endpoint (Complete Response) data for the approximately 65 patients enrolled to date.

UroGen plans to present the topline data in January 2019, with the full dataset expected at a medical meeting in the second quarter of 2019.

"We are pleased by the FDA’s support for UGN-101 and recognition of the potential clinical benefit that UGN-101 presents for LG UTUC as a potentially organ-sparing, non-invasive therapy for this disease," said Ron Bentsur, Chief Executive Officer of UroGen. "We are excited about the progress that we continue to make across our clinical pipeline and look forward to collaborating with the FDA to bring this potentially transformative therapy to patients with LG UTUC."

Breakthrough Therapy Designation (BTD) was granted by the FDA for UGN1-101 for the treatment of LG UTUC in October 2018. UroGen remains on track to initiate the UGN-101 Rolling NDA Submission to the FDA in Q4 2018 and complete the submission in Q2 2019, with potential approval expected in 2019.

Additional Highlights and Upcoming Milestones

UGN-102 Clinical Development:
UroGen is enrolling patients as part of its Phase 2b single-arm, open-label, multi-center trial designed to assess the efficacy and safety of UGN-102 (mitomycin gel) for intravesical instillation as a potential first-line chemoablation agent in the treatment of patients with LG Non-Muscle Invasive Bladder Cancer (NMIBC) at risk for recurrence.
Initial data from the trial is expected in 1H 2019.
Similar to LG UTUC, there are currently no drugs approved by the FDA as first-line treatment for NMIBC, and only three drugs have been approved by the FDA, all as adjuvant treatments, following TURBT (transurethral resection of bladder tumor).
UGN-102 represents a very substantial opportunity in UroGen’s pipeline with the potential to initially address up to approximately 85,000 patients for whom TURBT is no longer effective.1
Advancing the Potential of the RTGel Platform:
Allergan continues to enroll patients in its Phase 2 trial of BotuGel, UroGen’s RTGel in combination with BOTOX2, for the treatment of overactive bladder. This clinical trial, if successful, has the potential to demonstrate the broad applicability of the RTGel platform beyond uro-oncology. Phase 2 data is expected in 2019.
Corporate Developments:
UroGen strengthened its leadership team with the appointment of Jones "Woody" Bryan, Ph.D., as Senior Vice President, Business Development. Dr. Bryan is a seasoned industry veteran who brings over 25 years of industry experience. He is focused on the integration of corporate strategy and business development to assess potential partnerships, both inbound and outbound, and bolster UroGen’s product portfolio.
Third Quarter 2018 Financial Results

As of September 30, 2018, cash and cash equivalents totaled $109.5 million.
Research and development expenses for the nine months ended September 30, 2018 were $25.5 million, including non-cash share-based compensation expense of $9.1 million. Research and development expenses for the three months ended September 30, 2018 were $9.6 million, including non-cash share-based compensation expense of $3.8 million.
General and administrative expenses for the nine months ended September 30, 2018 were $27.0 million, including non-cash share-based compensation expense of $12.7 million. General and administrative expenses for the three months ended September 30, 2018 were $10.7 million, including non-cash share-based compensation expense of $5.7 million.
The Company reported a net loss of $51.9 million, or basic and diluted net loss per ordinary share of $3.30, for the nine months ended September 30, 2018. The Company reported a net loss of $20.5 million, or basic and diluted net loss per ordinary share of $1.28, for the three months ended September 30, 2018.
Conference Call & Webcast Information

Members of UroGen’s management team will host a live conference call and webcast today at 8:30 a.m. Eastern Time to review the Company’s financial results and provide a general business update. Due to observance of the Veteran’s Day holiday in the United States on November 12, 2018, UroGen’s corresponding 6-K will be filed with the Securities and Exchange Commission (SEC) before market on November 13, 2018.

The live webcast can be accessed by visiting the Investors section of the Company’s website at View Source Please connect at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. Alternatively, please call (888) 771-4371 (U.S.) or (847) 585-4405 (International) to listen to the live conference call. The conference ID number for the live call will be 47697839. An archive of the webcast will be available for two weeks on the Company’s website.

On November 12, 2018 Unum Therapeutics Inc. (NASDAQ: UMRX), a clinical-stage biopharmaceutical company focused on the development of novel cellular immunotherapies, reported that the Company will host an investor event to discuss its efforts in solid tumors on Monday November 19, 2018, from 8:30 a.m. to 10:00 a.m. ET in New York City (Press release, Unum Therapeutics, NOV 12, 2018, View Sourcenews-releases/news-release-details/unum-therapeutics-host-investor-event-its-efforts-realize" target="_blank" title="View Sourcenews-releases/news-release-details/unum-therapeutics-host-investor-event-its-efforts-realize" rel="nofollow">View Source [SID1234531331]).

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The event will feature guest speaker Charles S. Fuchs, MD, MPH, Director of the Yale Cancer Center, who will discuss the challenges and opportunities in HER2 malignancies. In addition, the Company will discuss the unmet need, clinical validation of ACTR707 and design of the ATTCK-34-01 Phase I trial using ACTR707 in combination with trastuzumab to target HER2-positive advanced cancers. The Company also will provide more details on the new BOXR platform to support its growing efforts in solid tumors.

To join the live webcast, please visit the investor relations section of the Unum Therapeutics website at View Source at least 10 minutes before the event begins.

On November 12, 2018 Neon Therapeutics, Inc. (Nasdaq: NTGN), a clinical-stage immuno-oncology company developing neoantigen-based therapeutics, reported financial results and provided a business update for the third quarter of 2018 (Press release, Neon Therapeutics, NOV 12, 2018, View Source [SID1234531425]).

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"Throughout the third quarter we continued to execute our strategy and are pleased with the progress we have made. Our neoantigen-based platform and product candidates have the potential to have a meaningful impact on patients and we recently presented a series of encouraging data at major scientific meetings that support that goal," said Hugh O’Dowd, president and chief executive officer of Neon. "We are excited to be a leader in the neoantigen field building on the body of science across multiple product candidates that span both T cell and vaccine modalities. Importantly, the strength of our balance sheet supports these promising clinical programs through value-creating inflection points."

Third Quarter and Recent Business Highlights

· In August 2018, Neon announced the appointment of Jolie M. Siegel as general counsel and secretary. Ms. Siegel leads the legal, intellectual property, compliance and corporate governance functions for the company and reports to Hugh O’Dowd, president and chief executive officer of Neon.

· In October 2018, Neon presented updated data from NT-001, its ongoing Phase 1b clinical trial evaluating NEO-PV-01 in the metastatic setting, at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress in Munich, Germany.

· In October 2018, Neon announced a research collaboration with Natera, Inc., utilizing Natera’s Signatera (RUO) circulating tumor DNA assay as a biomarker to assess treatment response to NEO-PV-01 in Neon’s NT-002 clinical trial.

· In November 2018, Neon announced the appointment of Robert Bazemore to its Board of Directors. Mr. Bazemore is currently President and Chief Executive Officer of Epizyme.

· In November 2018, Neon presented supplementary data from NT-001 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 33rd Annual Meeting in Washington, D.C.

· In November 2018, Neon presented new data relating to its NEO-PTC-01 program at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)
Third Quarter 2018 Financial Results

· Cash Position: As of September 30, 2018, cash, cash equivalents and marketable securities were $121.7 million, as compared to cash, cash equivalents and marketable securities of $79.7 million as of December 31, 2017.

· R&D Expenses: R&D expenses were $14.4 million for the quarter ended September 30, 2018, compared to $11.5 million for the same quarter last year. The increase of $2.9 million was driven by higher personnel costs as well as increased costs related to the advancement of NEO-PV-01.

· G&A Expenses: G&A expenses were $4.6 million for the quarter ended September 30, 2018, compared to $2.6 million for the same quarter last year. The increase of $2.0 million was primarily driven by increased costs of being a public company, including professional fees, personnel costs and other related costs.

· Net Loss Attributable to Common Stockholders: Net loss attributable to common stockholders was $18.4 million for the quarter ended September 30, 2018, or $0.67 per basic and diluted share, as compared to a net loss attributable to common stockholders of $16.5 million for the same quarter last year, or $9.59 per basic and diluted share.

On November 12, 2018 Unum Therapeutics Inc. (NASDAQ: UMRX), a clinical-stage biopharmaceutical company focused on the development of novel cellular immunotherapies, reported financial results and provided a corporate update for the third quarter ended September 30, 2018 and recent activities (Press release, Unum Therapeutics, NOV 12, 2018, View Source [SID1234531239]).

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"In the third quarter of 2018, we continued to make significant progress advancing our clinical pipeline," said Chuck Wilson, CEO of Unum. "We are excited to announce today that we have selected ACTR707 in combination with rituximab for further development in patients with relapsed or refractory non-Hodgkin lymphoma. Early data from the ATTCK-20-03 trial continue to support our novel ACTR platform and potential best-in-class product profile. In addition, we remain on track with our two additional clinical studies, ATTCK-17-01 in multiple myeloma and ATTCK-34-01 in HER2+ solid tumors, and are looking forward to presenting further updates on all trials at upcoming scientific conferences in December. Finally, we are pleased with our significant progress in developing a second novel technology platform, BOXR, which is designed to improve T cell functionality in solid tumors, and we look forward to developing future products based on this platform."

Recent Highlights

Selected ACTR707 as Lead Candidate for Further Development in r/r NHL: Unum has elected to advance ACTR707 in combination with rituximab as its lead product candidate to treat patients with relapsed or refractory CD20-positive B cell non-Hodgkin lymphoma (r/r NHL). As a result of this decision, Unum intends to conclude enrollment in the ATTCK-20-2 study, in the first half of 2019. The selection of ACTR707 as the lead construct in r/r NHL was based on the emerging clinical data from the Phase I ATTCK-20-03 clinical trial, the continuing progress in the ATTCK-20-03 study, and the Company’s desire to efficiently manage resources. At the first dose level of that trial, three out of six treated patients achieved a complete response, two of which remained ongoing at the time of the September 4 data cut off. Additionally, no dose-limiting toxicities (DLTs), serious or severe adverse events of cytokine release syndrome or neurotoxicity were observed in any patients. The findings in ATTCK-20-03 build on the encouraging data observed in cohort 1 of the ATTCK-20-2 trial, which evaluated ACTR087 in combination with

rituximab in patients with r/r NHL. Updated data from the ATTCK-20-03 trial will be presented at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) meeting in December.

Continued Progress with ATTCK-17-01 Phase I trial: Unum is continuing to enroll and dose patients in ATTCK-17-01, a Phase I, multi-center, open-label clinical trial designed to test the safety, tolerability, and anti-myeloma activity of ACTR087 used in combination with SEA-BCMA in patients with r/r multiple myeloma through the dose escalation phase of the trial. This is the first clinical trial conducted under the strategic collaboration with Seattle Genetics. Unum plans to report preliminary data from early dose cohorts at the upcoming ASH (Free ASH Whitepaper) meeting in December 2018.

On Track to Initiate ATTCK-34-01 Trial by Year End in Solid Tumors: Unum’s investigational new drug (IND) application for ACTR T cells in combination with trastuzumab for the treatment of patients with HER2+ advanced cancers has been accepted, and Unum plans to initiate the multi-center Phase I ATTCK-34-01 trial by the end of 2018, and announce preliminary data in 2019. ATTCK-34-01, Unum’s first ACTR combination study in solid tumors, is a multicenter, single-arm, open-label dose escalation study evaluating ACTR T cells in combination with trastuzumab and includes a planned expansion at the recommended Phase 2 dose. The primary study objectives are to assess the safety and tolerability of the combination, and to define dose recommendations for further study. Additional objectives include assessment of anti-tumor activity, ACTR T cell persistence and trastuzumab pharmacokinetics. Unum expects to present updated preclinical data along with the clinical trial design at the San Antonio Breast Cancer Symposium in December 2018.

Announced New Technology Platform to Expand Clinical Development Efforts in Solid Tumors: At the Society for Immunotherapy (SITC) (Free SITC Whitepaper) meeting in November, Unum presented preclinical data on a new technology platform called "BOXR," or Bolt-On Chimeric Receptor, that improves the functionality of T cells, enabling them to be more effective in solid tumor cancers. BOXR works with ACTR T cells or CAR T cells to significantly improve T cell functionality. Unum will disclose more details on this new platform, as well as its broader efforts in solid tumors, at the upcoming investor event on November 19, 2018, in New York, featuring guest speaker Charles S. Fuchs, MD, MPH, of Yale Cancer Center. The event will be available also via live webcast.

Third Quarter 2018 Financial Results

Collaboration Revenue: Collaboration revenue recognized during the third quarter ended September 30, 2018 and 2017, of $2.0 million and $2.3 million, respectively, reflects the recognition of a portion of the $25.0 million upfront payment received from Seattle Genetics under Unum’s collaboration agreement as well as reimbursements of research and development costs by Seattle Genetics. Effective January 1, 2018, Unum adopted the new revenue recognition standard, ASC 606, which changed the manner in which the Company recognizes revenue from this collaboration agreement compared to the prior year period.

R&D Expenses: Research and development expenses were $10.3 million for the third quarter ended September 30, 2018, compared to $8.2 million for the same period last year. The increase reflects higher clinical trial costs for the active Phase I clinical trials, as well as increased personnel-related costs, materials and facility-related costs related to scaling manufacturing processes, and increased consultant costs. This was partially offset primarily by a decrease in manufacturing costs incurred for the Phase I clinical trial of ACTR087 in combination with rituximab.

G&A Expenses: General and administrative expenses for the third quarter ended September 30, 2018, were $2.4 million, compared to $1.3 million for the same period last year. The increase is primarily due to expenses around operating as a public company and higher personnel related costs.

Net Loss: Net loss attributable to common stockholders was $10.2 million, or $0.34 per share, for the third quarter ended September 30, 2018, and $7.0 million, or $0.69 per share, for the same period last year.

Cash, Cash Equivalents and Marketable Securities: As of September 30, 2018, Unum had cash, cash equivalents, and marketable securities of $87.1 million. Today, the Company updated its cash runway and now believes that its existing cash, cash equivalents, and marketable securities will fund operating expenses and capital expenditure requirements through at least June 2020, without considering $15.0 million in available borrowings under its loan and security agreement, as a result of its decision to conclude enrollment in the ATTCK-20-2 study in the first half of 2019.

On November 12, 2018 Gilead Sciences, Inc. (Nasdaq: GILD) reported that Robin L. Washington, Gilead’s Executive Vice President and Chief Financial Officer, and John McHutchison, AO, MD, Gilead’s Chief Scientific Officer and Head of Research & Development, will participate in a fireside chat at the Evercore ISI HealthCONx Conference in Boston on Tuesday, November 27 at 9:30 a.m. Eastern Time (Press release, Gilead Sciences, NOV 12, 2018, View Source;p=irol-newsArticle&ID=2376801 [SID1234531240]).

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The audio portion of the fireside chat will be accessible live through the company’s Investors page at www.gilead.com/investors. Please connect to the company’s website at least 15 minutes prior to the start of the presentation to ensure adequate time for any software download that may be required to listen to the webcast. The replay will be available for 14 days following the presentation.