On November 7, 2019 Exicure, Inc. (Nasdaq: XCUR), a pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) technology, reported financial results for the third quarter ended September 30, 2019 and provided an update on corporate progress (Press release, Exicure, NOV 7, 2019, View Source [SID1234550657]).

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"Throughout the third quarter we have continued to execute against the strategic goals we set early in the year," said Dr. David Giljohann, Exicure’s chief executive officer. "Our immuno-oncology clinical trial is progressing as anticipated, while we continue to lay the groundwork for expanding our SNA platform in neurology. This scientific progress has been matched with expanded financial resources arising from our recent $63.3 million public offering and Nasdaq listing. In the coming quarters we look forward to building our organization to enhance our strategic execution," concluded Dr. Giljohann.

Third Quarter Corporate Progress and Recent Developments

AST-008 Phase 1b/2 clinical trial on track
As of November 1, 2019, we have dosed 13 patients in the first four cohorts of the Phase 1b stage of the clinical trial;
No treatment related adverse events or dose-limiting toxicity was observed;
Expect to disclose preliminary results from the Phase 1b in December of 2019.
Presented Positive Biomarker Results from Clinical Trial of XCUR17
Presentation at Oligonucleotide Therapeutics Society highlighted work by Dr. James Krueger at The Rockefeller University, in collaboration with Exicure, which examined the effects of XCUR17 on skin biopsies collected from patients in the Phase 1 trial;
Clinical findings in the Phase 1 trial matched reductions in keratin 16 protein and epidermal thickness observed in the patient biopsies;
Clinical findings were also shown to be correlated with downstream psoriasis-related inflammation markers including reductions in beta defensin 4A, interleukin 19, and interleukin 36A versus psoriatic skin at baseline.
Enhanced Financial Resources
Closed oversubscribed underwritten public offering of 31,625,000 shares of common stock at $2.00 per share for gross proceeds of $63.3 million with net proceeds of approximately of $58.8 million;
Up-listed from the OTC to the Nasdaq Stock Market.
Third Quarter 2019 Financial Results and Financial Guidance

Cash Position: Cash and cash equivalents were $70.4 million as of September 30, 2019 compared to $26.3 million as of December 31, 2018.

Research and Development (R&D) Expenses: Research and development expenses were $4.2 million for the quarter ended September 30, 2019, compared to $4.0 million for the quarter ended September 30, 2018. The increase was primarily due to higher employee-related expenses of $0.5 million and higher platform and discovery related expense of $0.1 million, partially offset by lower clinical development program expenses of $0.4 million.

General and Administrative (G&A) Expenses: General and administrative expenses were $2.2 million for the quarter ended September 30, 2019, compared to $1.9 million for the quarter ended September 30, 2018. This increase is primarily due to costs related to the recruitment of two new board members and an open executive position, as well as incurred Nasdaq listing costs.

Net Loss: Net loss was $5.8 million for the quarter ended September 30, 2019, compared to net loss of $5.3 million for the quarter ended September 30, 2018. This increase was due to a $0.4 million reduction in Other income attributable to the (non-cash) fair value adjustment of our common stock warrant liability, the $0.3 million increase in G&A expenses described above, the $0.2 million increase in R&D expenses described above, partially offset by the addition of $0.5 million of revenue associated with the Dermelix transaction.

Cash Runway Guidance: We believe that, based on our current operating plans and estimates of expenses, as of the date of this press release, our existing cash and cash equivalents will be sufficient to meet our anticipated cash requirements in excess of twelve months.

On November 7, 2019 Bicycle Therapeutics plc (NASDAQ:BCYC), a clinical-stage biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycles) technology, reported financial results for the third quarter ended September 30, 2019 and discussed recent corporate updates (Press release, Bicycle Therapeutics, NOV 7, 2019, View Source [SID1234550656]).

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"The significant progress we have made in the past few months is instrumental to our goal of advancing our novel pipeline of Bicycle drug candidates through the clinic," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. "We’ve bolstered all three areas of the pipeline, namely, our wholly-owned Bicycle Toxin Conjugate and immuno-oncology programs, as well as our collaborations to develop new Bicycle-based therapies for indications beyond oncology. We have also continued to strengthen our leadership team both at the corporate and Board levels. These efforts further position the Company to evaluate the potential of Bicycles to enable possible first-in-class medicines that transform the treatment paradigm for people living with a broad range of serious diseases, in ways that existing modalities cannot."

Third Quarter 2019 and Recent Highlights

Presenting New Preclinical Data for Novel, Fully Synthetic Bicycle Tumor-targeted Immune Cell Agonists (TICAs) at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 2019 Annual Meeting. This week, Bicycle is presenting new data showing that its lead immuno-oncology candidate, BT7480, a TICA targeting Nectin-4 and agonizing CD137, rapidly penetrates tumors and effects powerful anti-tumor activity in preclinical models. In addition to data on BT7480, the Company will present preclinical research at SITC (Free SITC Whitepaper) on other emergent Bicycle TICA strategies. Details of the Company’s poster presentations on Saturday, November 9, 2019 can be found in the News section of bicycletherapeutics.com.
Enhanced Executive Team and Board of Directors. In October 2019, Bicycle announced the appointment of Nigel Crockett, Ph.D., as Chief Business Officer and of Veronica Jordan, Ph.D., to the Company’s Board of Directors.
Expanded Neuroscience Collaborations to Include Oxford University’s Oxford Drug Discovery Institute (ODDI). Bicycle announced that it will collaborate with ODDI to use Bicycle technology for the development of novel therapeutics for dementia. This expands upon the collaboration announced in May 2019 between Bicycle and the Dementia Discovery Fund (DDF), a specialized venture capital fund focused on discovering and developing novel therapies for dementia. If promising lead compounds are identified, Bicycle will have rights to the development of the resulting intellectual property and, with DDF, will have the option to jointly establish a new company to develop those compounds.
Presented New Translational Data for Lead Asset BT1718 and Preclinical Data for Other Bicycle Toxin Conjugates at AACR (Free AACR Whitepaper)-NCI-EORTC 2019. Bicycle presented new translational data for BT1718 and preclinical data for BT5528 and BT8009 during poster sessions at the 2019 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper). The translational data for BT1718 characterize enrollment criteria for identifying expansion cohorts in the Phase IIa part of the ongoing Phase I/IIa trial.
Presented Updated Data from Phase I/IIa Trial Evaluating BT1718 in Patients with Advanced Solid Tumors at ESMO (Free ESMO Whitepaper) 2019 Annual Congress. Bicycle and Cancer Research UK presented updated data from the ongoing Phase I portion of the Phase I/IIa trial evaluating BT1718 in patients with advanced solid tumors. As of August 7, 2019, 54% of evaluable patients dosed had stable disease at the eight-week timepoint, including a patient who experienced a 45% reduction in a target lesion, and BT1718 appeared tolerable with once-weekly dosing.
Upcoming Investor Presentations

Bicycle will present at the following investor conferences in the fourth quarter of 2019:

Jefferies London Healthcare Conference on Wednesday, November 20, 2019 at 2:40 p.m. GMT (9:40 a.m. ET) in London, England
Piper Jaffray 31st Annual Healthcare Conference on Tuesday, December 3, 2019 at 3:30 p.m. ET in New York, NY
A live webcast of each presentation will be accessible in the Investors & Media section of Bicycle’s website at bicycletherapeutics.com. Archived replays of the webcasts will be available for 90 days following the presentation dates.

Financial Results

Cash was $96.0 million as of September 30, 2019, compared with $63.4 million as of December 31, 2018. The September 30, 2019 cash balance excludes a UK research and development incentive payment of approximately $6.0 million received in October 2019.
Research and development expenses were $6.1 million for the three months ended September 30, 2019, compared to $5.6 million for the three months ended September 30, 2018. The increase of $0.4 million is primarily due to $0.3 million of incremental non-cash share-based compensation expense, as well as other personnel related costs.
General and administrative expenses were $4.8 million for the three months ended September 30, 2019, compared to $2.3 million for the three months ended September 30, 2018. The increase of $2.5 million is primarily due to a $0.9 million unfavorable effect of foreign exchange rates, $0.7 million in personnel related costs, including $0.3 million of incremental non-cash share-based compensation expense, as well as increased professional fees related to operations as a public company.
Net loss was $9.5 million, or $(0.53) basic and diluted net loss per share, for the three months ended September 30, 2019, compared to net loss of $7.7 million, or $(17.73) basic and diluted net loss per share, for the quarter ended September 30, 2018.

On November 7, 2019 Triumvira Immunologics, Inc. (Triumvira), a private, clinical-stage biopharmaceutical company developing a novel platform for engineering T-cells to attack cancers, reported that the U.S. Food & Drug Administration (FDA) has granted Fast Track designation for its novel T-cell therapy product TAC01-CD19 in patients with relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL) after at least 2 prior systemic therapies (Press release, Triumvira Immunologics, NOV 7, 2019, View Source [SID1234550655]). A Phase 1/2 study (TACTIC-19) conducted in patients with CD19-positive B-cell malignancies, including DLBCL, is expected to be initiated by the end of 2019.

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"FDA’s decision to grant Fast Track designation to TAC01-CD19 is an important recognition of both Triumvira’s differentiated cell therapy technology and the critical need to develop new therapies to address the unmet medical need in the treatment of B-cell lymphomas," commented Paul Lammers, MD, MSc., President and CEO of Triumvira. "With our innovative TAC technology, we hope to significantly improve upon the limitations of existing cell therapies, including the risk of cytokine release syndrome (CRS) and neurotoxicity, which would allow us to expand the number of patients eligible to receive this type of treatment."

TAC01-CD19 will be tested at four leading lymphoma clinical study centers in the U.S. and Canada. Based on its preclinical profile, TAC01-CD19 has the potential to represent a significant advancement in T-cell therapy.

About TAC01-CD19

Despite transformational efficacy with existing approved Chimeric Antigen Receptor T-Cells (CAR-T), a significant unmet need remains due to substantial CAR-T toxicities and limited tumor types where CAR-T is effective. Triumvira is developing a proprietary T-Cell Antigen Coupler (TAC) receptor which is structurally and biologically distinct from CAR-T. The first of our pipeline product candidates, TAC01-CD19 is a novel T-cell therapy product targeting CD19, a validated target in lymphomas and leukemias. The product comprises patient-derived T-cells that have been genetically engineered to express the CD19 T-cell Antigen Coupler (TAC). Preclinical data suggest that TAC01-CD19 has the potential for being highly efficacious with minimal side effects in hematological malignancies.

About CD19 and Diffuse Large B-Cell Lymphoma (DLBCL)

CD19 is a B-cell marker and is expressed on the surface of B-cell malignancies such as Diffuse Large B-Cell Lymphoma (DLBCL). DLBCL is a subtype of Non-Hodgkin Lymphomas (NHLs). DLBCL impacted approximately 26,000 patients in the U.S. in 2018. While the objective response rates of 50 – 70% observed for treatment of large B-cell lymphomas with currently marketed patient-derived T-cell products are good, there still exists a significant percentage of patients who either do not benefit from treatment or who are not able to tolerate the serious toxicities associated with these products.

About U.S. FDA’s Fast Track Designation Program

The FDA’s Fast Track program was established to facilitate the development and expedite the review of drugs with the potential to treat serious conditions and address an unmet medical need. Companies that receive Fast Track designation are provided the opportunity for more frequent interactions with FDA during clinical development and are eligible for accelerated approval and/or priority review, if relevant criteria are met. Additionally, companies that receive Fast Track designation are allowed to submit completed sections of their New Drug Application (NDA) or Biologics License Application (BLA) for the drug on a rolling basis, resulting in the potential for an expedited FDA review process.

On November 7, 2019 Seattle Genetics, Inc. (Nasdaq:SGEN) reported data from its ADCETRIS (brentuximab vedotin) clinical development program at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition taking place December 7-10 in Orlando, Fla (Press release, Seattle Genetics, NOV 7, 2019, View Source [SID1234550654]). ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical Hodgkin lymphoma (HL) and expressed on the surface of several types of peripheral T-cell lymphomas. ADCETRIS is being evaluated globally as the foundation of care for CD30-expressing lymphomas in more than 70 corporate- and investigator-sponsored clinical trials.

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"At this year’s ASH (Free ASH Whitepaper) meeting, ADCETRIS will be featured in 15 data presentations, including updated analyses from ECHELON-1 and ECHELON-2 phase 3 frontline trials," said Roger Dansey, M.D., Chief Medical Officer at Seattle Genetics. "We are encouraged by the ECHELON-1 update supporting a sustained progression-free survival benefit for ADCETRIS in combination with AVD when compared to ABVD in advanced classical Hodgkin lymphoma and additional analyses from trials evaluating ADCETRIS in combination with nivolumab. We continue to invest in our ADCETRIS clinical development program with the goal of improving outcomes for patients."

Details of oral presentations featured at ASH (Free ASH Whitepaper) include:

Safety and Efficacy of Brentuximab Vedotin in Combination with AVD in Stage II-IV HIV-Associated Classical Hodgkin Lymphoma: Results of the Phase 2 Study, AMC 085
Abstract: 130
Presenter: P. Rubinstein, Rush University Medical Center, Chicago, Ill.
Session: Oral presentation Hodgkin Lymphoma and T/NK Cell Lymphoma – Clinical Studies: Combination Chemotherapy and Biomarkers of Response in Hodgkin Lymphoma
Date and Time: Saturday, December 7, 10:15 a.m. ET
Location: Tangerine 2 (WF2)

Brentuximab Vedotin in First Refractory/Relapsed Classical Hodgkin Lymphoma Patients Treated By Chemotherapy (ICE) before Autologous Transplantation. Final Analysis of Phase II Study
Abstract: 132
Presenter: A. Stamatoullas, Departement d’Hematologie, Centre Henry Becquerel, Rouen, France
Session: Oral presentation Hodgkin Lymphoma and T/NK Cell Lymphoma – Clinical Studies: Combination Chemotherapy and Biomarkers of Response in Hodgkin Lymphoma
Date and Time: Saturday, December 7, 10:45 a.m. ET
Location: Tangerine (WF2)

Phase 2 Study of Frontline Brentuximab Vedotin Plus Nivolumab in Patients with Hodgkin Lymphoma Aged ≥ 60 Years
Abstract: 237
Presenter: C. Yasenchak, Willamette Valley Cancer Institute and Research Center/US Oncology Research, Eugene, Ore.
Session: Oral presentation Hodgkin Lymphoma and T/NK Cell Lymphoma – Clinical Studies: Immunotherapy Approaches in Hodgkin Lymphoma
Date and Time: Saturday, December 7, 2:30 p.m. ET
Location: W224

Brentuximab Vedotin and Nivolumab for Relapsed or Refractory Classical Hodgkin Lymphoma: Long-term Follow-up Results from the Single-arm Phase 1/2 Study
Abstract: 238
Presenter: A. Moskowitz, Memorial Sloan Kettering Cancer Center, New York, N.Y.
Session: Oral presentation Hodgkin Lymphoma and T/NK Cell Lymphoma – Clinical Studies: Immunotherapy Approaches in Hodgkin Lymphoma
Date and Time: Saturday, December 7, 2:45 p.m. ET
Location: W224

A Phase I/II Trial of Brentuximab Vedotin (BV) Plus Rituximab (R) as Frontline Therapy for Patients with Immunosuppression-Associated CD30+ and/or EBV+ Lymphomas
Abstract: 351
Presenter: W. Pearse, Loyola University Medical Center, Maywood, Ill.
Session: Oral presentation Aggressive Lymphoma (Diffuse Large B-Cell and Other Aggressive B-Cell Non-Hodgkin Lymphomas) – Results from Prospective Clinical Trials: Optimizing Frontline Chemotherapy
Date and Time: Sunday, December 8, 8:00 a.m. ET
Location: Hall E2

An Exploratory Analysis of Brentuximab Vedotin plus CHP (A+CHP) in the Frontline Treatment of Patients with CD30+ Peripheral T-cell Lymphomas (ECHELON-2): Impact of Consolidative Stem Cell Transplant
Abstract: 464
Presenter: K. Savage, British Columbia Cancer Centre for Lymphoid Cancer, University of British Columbia and the Department of Medical Oncology, Vancouver, B.C., Canada
Session: Oral presentation Hodgkin Lymphoma and T/NK Cell Lymphoma – Clinical Studies: Novel Therapies in Peripheral T-cell Lymphomas
Date and Time: Sunday, December 8, 12:15 p.m. ET
Location: Valencia D (W415D)

Details of company-sponsored presentations are as follows:

Patterns of Care and Clinical Outcomes in Peripheral T-Cell Lymphoma Patients Receiving First-Line Treatment in Routine Clinical Practice in France and the United Kingdom
Abstract: 3482
Session: Poster Presentation
Date and Time: Sunday, December 8, 6:00-8:00 p.m. ET
Location: Hall B

Real-World Treatment Patterns and Overall Survival Among Medicare Fee-for-Service Beneficiaries Newly Diagnosed with Peripheral T-Cell Lymphoma (PTCL)
Abstract: 3492
Session: Poster Presentation
Date and Time: Sunday, December 8, 6:00-8:00 p.m. ET
Location: Hall B

Brentuximab Vedotin with Chemotherapy for Stage III/IV Classical Hodgkin Lymphoma (cHL): Four-Year Update of the ECHELON-1 Study
Abstract: 4026
Session: Poster Presentation
Date and Time: Monday, December 9, 6:00-8:00 p.m. ET
Location: Hall B

Details of select investigator-sponsored presentations are as follows:

Long-Term Follow-up Confirms Durability of Single-Agent Brentuximab Vedotin as Pre-Transplant Salvage for Hodgkin Lymphoma
Abstract: 1555
Session: Poster Presentation
Date and Time: Saturday, December 7, 5:30-7:30 p.m. ET
Location: Hall B

A Pilot Study of Brentuximab Vedotin Combined with AVD Chemotherapy and Radiotherapy in Patients with Newly Diagnosed Early Stage, Unfavorable Risk Hodgkin Lymphoma
Abstract: 2834
Session: Poster Presentation
Date and Time: Sunday, December 8, 6:00-8:00 p.m. ET
Location: Hall B

Preliminary Results from a Phase 2 Trial of Brentuximab Vedotin Plus Cyclophosphamide, Doxorubicin, Etoposide, and Prednisone (CHEP-BV) Followed by BV Consolidation in Patients with CD30-Expressing Peripheral T-cell Lymphomas
Abstract: 4023
Session: Poster Presentation
Date and Time: Monday, December 9, 6:00-8:00 p.m. ET
Location: Hall B

Details of company-sponsored trials in progress are as follows:

Brentuximab Vedotin in Combination with Nivolumab, Doxorubucin, and Dacarbazine in Newly Diagnosed Patients with Advanced Stage Hodgkin Lymphoma
Abstract: 2836
Session: Poster Presentation
Date and Time: Sunday, December 8, 6:00-8:00 p.m. ET
Location: Hall B

Brentuximab Vedotin in Front-Line Therapy of Hodgkin Lymphoma (HL) and CD30-Expressing Peripheral T-Cell Lymphoma (PTCL) in Adults Age 60 and Above
Abstract: 2852
Session: Poster Presentation
Date and Time: Sunday, December 8, 6:00-8:00 p.m. ET
Location: Hall B

A Phase 2 Study of Retreatment with Brentuximab Vedotin in Patients with cHL, sALCL or other CD30 Expressing PTCL
Abstract: 4054
Session: Poster Presentation
Date and Time: Monday, December 9, 6:00-8:00 p.m. ET
Location: Hall B

On November 7, 2019 Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for respiratory diseases, cancer and other indications, reported that the Company will host an R&D event in New York on Tuesday, November 19, 2019 from 12:00 – 3:30 PM EST (Press release, Pieris Pharmaceuticals, NOV 7, 2019, View Source [SID1234550653]).

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The R&D event will feature presentations from management and thought leaders in immuno-oncology and respiratory diseases, including:

Michael A. Curran, PhD, Associate Professor, Department of Immunology and Scientific Director, ORBIT Platform, The UT MD Anderson Cancer Center
Geoffrey Y. Ku, MD, Assistant Attending Physician and Head, Esophagogastric Section, Gastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering
Anuradha Ray, PhD, Professor of Medicine, Department of Immunology and UPMC Endowed Chair in Lung Immunology Medicine, University of Pittsburgh
Sally E. Wenzel, MD, Professor of Medicine, Department of Medicine; Chair, Department of Occupational & Environmental Health; Acting Director, Asthma Environmental Lung Health Institute and UPMC Endowed Chair of Translational Airway Biology, University of Pittsburgh
Presentations will include expert discussant perspectives on recently presented data for PRS-343 and PRS-060, emerging data from the ongoing PRS-343 combination trial with atezolizumab, and perspectives on how these drug candidates could best fit into the emerging landscapes of asthma and immuno-oncology.

The event will be accessible via a live webcast through this link beginning at 12:30 PM EST on November 19, 2019.

In-person attendance is by invitation only. For more information, please contact [email protected].