On August 7, 2019 Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL) reported its second quarter 2019 financial results and highlights (Press release, Synta Pharmaceuticals, AUG 7, 2019, View Source [SID1234538288]):

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Madrigal has continued to progress on several important fronts during the second quarter. We have moved forward with our Phase 3 study of MGL-3196 (resmetirom) in patients with biopsy-proven non-alcoholic steatohepatitis (NASH) and liver fibrosis (MAESTRO-NASH)," stated Paul Friedman, M.D., Chief Executive Officer of Madrigal. "We were also fortunate to add Jim Daly to our Board of Directors. Jim’s deep commercial expertise will be invaluable as we move forward with development of resmetirom in NASH and Non-Alcoholic Fatty Liver Disease (NAFLD). In addition, in recognition of our clinical development progress and corresponding growth of the Company, we promoted Becky Taub, M.D., to President of R&D."

Becky Taub, M.D.,CMO, President, Research & Development of Madrigal, added, "Madrigal is enrolling patients in our MAESTRO-NASH Phase 3 clinical study, and although it’s early in the process, we are encouraged by the rate of site openings and patient screening numbers. We are also pleased to announce that our abstract "Effects of Resmetirom (MGL-3196) on Hepatic Fat, Lipids, Liver Enzymes and Markers of Liver Fibrosis in an Open-Label 36-Week Extension Study in NASH Patients" has been selected for oral presentation at the Liver Meeting AASLD 2019 in Boston, November 2019. A poster, "Steatosis and Fibrosis Measured as Continuous Variables on Paired, Serial Liver Biopsies in the Resmetirom (MGL-3196) 36-Week Phase 2 NASH Study" will also be presented at AASLD meeting."

Additional information about Madrigal’s Phase 3 study in patients with NASH [NCT03900429] can be obtained at www.clinicaltrials.gov.

Financial Results for the Three and Six Months Ended June 30, 2019

As of June 30, 2019, Madrigal had cash, cash equivalents and marketable securities of $466.4 million, compared to $483.7 million at December 31, 2018. Cash used in operating activities during the first six months of 2019 was $18.0 million.

Operating expenses were $22.7 million and $40.8 million for the three and six month periods ended June 30, 2019, compared to $7.8 million and $14.9 million in the comparable prior year periods.

Research and development expenses for the three and six month periods ended June 30, 2019 were $15.6 million and $28.0 million compared to $5.1 million and $10.3 million in the comparable prior year periods. The increase is primarily attributable to additional activities related to initiation of our Phase 3 clinical trial in NASH, including a payment due related to a milestone achieved under our agreement with Roche, an increase in headcount and increased non-cash stock compensation from stock option awards.

General and administrative expenses for the three and six month periods ended June 30, 2019 were $7.1 million and $12.9 million compared to $2.7 million and $4.6 million in the comparable prior year periods. The increase is due primarily to higher non-cash stock compensation expense from stock option awards.

Interest income for the three and six month periods ended June 30, 2019 was $3.0 million and $6.0 million compared to $1.2 million and $1.9 million in the comparable prior year periods. The change in interest income was due primarily to a higher average principal balance in our investment portfolio in 2019, and increased interest rates.

About resmetirom (MGL-3196)

Among its many functions in the human body, thyroid hormone, through activation of its beta receptor, plays a central role in controlling lipid metabolism, impacting a range of health parameters from levels of serum cholesterol and triglycerides to the pathological buildup of fat in the liver. Attempts to exploit this pathway for therapeutic purposes in cardio-metabolic and liver diseases have been hampered by the lack of selectivity of older compounds for the thyroid hormone receptor (THR)-ß, chemically-related toxicities and undesirable distribution in the body.

Madrigal recognized that greater selectivity for thyroid hormone receptor (THR)-ß and liver targeting might overcome these challenges and deliver the full therapeutic potential of THR-ß agonism. Madrigal believes that resmetirom is the first orally administered, small-molecule, liver- directed, truly ß-selective THR agonist.

Based on the positive Phase 2 clinical study results in patients with NASH (Phase 2 36-Week Results Press Release), Madrigal initiated a Phase 3 multinational, double-blind, randomized, placebo-controlled study of resmetirom in patients with non-alcoholic steatohepatitis (NASH) and fibrosis to resolve NASH and reduce progression to cirrhosis and/or hepatic decompensation (Phase 3 Initiation Press Release and ClinicalTrials.gov NCT03900429). Additionally, in both the NASH Phase 2 study, and a second positive Phase 2 clinical study in patients with heterozygous familial hypercholesterolemia (Phase 2 HeFH Results Press Release), significant reductions in multiple atherogenic lipids were observed. As a result, Madrigal is designing a Phase 3 study intended to treat the prevalent dyslipidemias in NAFLD and NASH patients and improve the fatty liver phenotype in this population.

On August 7, 2019 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers for patient enrichment, reported financial results for the second quarter ended June 30, 2019 and provided a corporate update (Press release, Jounce Therapeutics, AUG 7, 2019, View Source [SID1234538304]).

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"2019 has been a time of clinical progress and important strategic business development activity for Jounce, with the initiation of our Phase 2 EMERGE trial for vopratelimab, the completion of enrollment in our Phase 1 clinical trial of JTX-4014 and the recently announced renegotiation of our Celgene collaboration. These important developments demonstrate the value and utilization of our novel scientific platform and reverse translational analyses to further advance our immuno-oncology pipeline with an aim to match the right therapies to the right patients," said Richard Murray, Ph.D., chief executive officer and president of Jounce Therapeutics. "Our translational science platform has been further validated by the establishment of our new licensing agreement with Celgene for the worldwide rights to JTX-8064. Now that we have retained full worldwide rights to vopratelimab, JTX-4014 and all of our discovery programs, we look forward to advancing our broad pipeline of potential next-generation immuno-oncology therapies."

Wholly-owned Programs:
Vopratelimab (JTX-2011)

Initiated Phase 2 EMERGE trial: In June 2019, Jounce announced the initiation of dosing in the Phase 2 EMERGE clinical trial of its lead product candidate, vopratelimab, in combination with ipilimumab in patients with non-small cell lung cancer or urothelial cancer who have progressed on or after PD-1/PD-L1 inhibitor therapies.

The primary endpoint of EMERGE is overall response rate and secondary endpoints include safety, duration of response, progression free survival (PFS) and overall survival (OS). Additional important assessments will include close monitoring of ICOS hi CD4 T cell emergence, and a range of other biomarkers, including exploratory assessment of potential predictive biomarkers. Jounce expects to report preliminary efficacy and biomarker relationships to clinical outcomes for up to 80 patients in 2020.

Key data presented at AACR (Free AACR Whitepaper) 2019: In April 2019, Jounce presented two posters on vopratelimab at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. Highlights from the poster presentations include:

Patients in the ICONIC trial with the emergence of ICOS hi CD4 T cells demonstrated improved PFS and OS compared to patients with ICOS lo CD4 T cells, based on an analysis of a subgroup of patients with multiple solid tumor types including PD-1 inhibitor naive and PD-1 inhibitor experienced patients.

The characteristics of ICOS hi CD4 T cells associated with vopratelimab treatment via translational analyses demonstrated that vopratelimab stimulates only primed CD4 T cells with high levels of ICOS. The translational data shows that vopratelimab, unlike PD-1 inhibitors, leads to expansion and activation of peripheral CD4 T effector cells, and that these are observed in patients with clinical benefit.
JTX-4014

Completed enrollment of Phase 1 trial: Jounce is pleased to announce the completion of enrollment in the Phase 1 clinical trial of JTX-4014, its PD-1 inhibitor, and determination of the recommended Phase 2 dose. Jounce plans to report data from the trial in the second half of this year.
Discovery Pipeline

On track to announce next discovery candidate: Jounce continues to advance and develop its broad discovery pipeline, which includes multiple programs targeting T-regulatory cells, macrophages and stromal cells. Jounce expects to move its next novel program into IND-enabling studies later this year.
Licensed Program:

JTX-8064

Licensed JTX-8064: In July 2019, Jounce announced a new agreement in which Celgene exclusively licensed the worldwide rights to JTX-8064, a highly-selective, potential first-in-class antibody that targets the LILRB2 receptor on macrophages. Under this license agreement, Jounce received a $50.0 million non-refundable license fee and is eligible to receive up to $480.0 million in development, regulatory and commercial milestone payments, as well as potential royalties on worldwide sales. Celgene will be responsible for all development and commercialization of JTX-8064.

Jounce and Celgene also entered into a mutual agreement to terminate the original strategic collaboration agreement, established in July 2016. Jounce now retains full worldwide rights to its pipeline beyond JTX-8064, including vopratelimab, JTX-4014 and all discovery programs.
Second Quarter 2019 Financial Results:

Cash Position: As of June 30, 2019, cash, cash equivalents and investments were $152.0 million, compared to $195.9 million as of December 31, 2018. The decrease in cash, cash equivalents and investments was primarily due to operating costs incurred during the period. In July 2019, Jounce received a $50.0 million license fee pursuant to its new license agreement with Celgene.

Collaboration Revenue: Collaboration revenue was $17.4 million for the second quarter of 2019, compared to $19.4 million for the same period in 2018. Collaboration revenue during both periods represents non-cash revenue recognition relating to the $225.0 million upfront payment received in July 2016 upon the execution of Jounce’s original strategic collaboration with Celgene. In connection with the termination of the original strategic collaboration, Jounce expects that the remaining deferred revenue relating to the Celgene agreement will be fully recognized in the third quarter of 2019.

Research and Development Expenses: Research and development (R&D) expenses were $18.1 million for the second quarter of 2019, compared to $18.5 million for the same period in 2018. The decrease in R&D expenses was primarily due to $0.5 million of decreased external research and development costs attributable to vopratelimab manufacturing expenses incurred during the second quarter of 2018, $0.4 million of decreased external clinical and regulatory costs and $0.3 million of decreased lab consumables expenses. These decreases were partially offset by $0.7 million of increased employee compensation costs.

General and Administrative Expenses: General and administrative (G&A) expenses were $7.3 million for the second quarter of 2019, compared to $6.5 million for the same period in 2018. The increase in G&A expenses was primarily due to $0.5 million of increased employee compensation costs, including $0.3 million of increased stock-based compensation expense, and $0.3 million of increased other G&A costs to support Jounce’s operations.

Net Loss: Net loss was $7.0 million for the second quarter of 2019, or a basic and diluted net loss per share of $0.21. Net loss was $4.7 million for the same period in 2018, or a basic and diluted net loss per share of $0.14. The increase in net loss and net loss per share was primarily attributable to the decrease in non-cash collaboration revenue from the second quarter of 2018 to the second quarter of 2019.
Financial Guidance:

Jounce reiterates its updated revenue guidance and expects to record $50.0 million in cash revenue in 2019 related to the license of JTX-8064 and approximately $98.0 million in non-cash revenue in 2019 representing the remaining recognition of the Celgene upfront payment received in July 2016.

Based on its operating and development plans, Jounce continues to expect gross cash burn on operating expenses and capital expenditures for the full year 2019 to be approximately $80.0 million to $95.0 million.

Conference Call and Webcast Information:

Jounce Therapeutics will host a live conference call and webcast today at 8:00 a.m. ET. To access the conference call, please dial (866) 916-3380 (domestic) or (210) 874-7772 (international) and refer to conference ID 4484315. The live webcast can be accessed under "Events & Presentations" in the Investors and Media section of the company’s website at www.jouncetx.com. The webcast will be archived and made available for replay on the company’s website approximately two hours after the call and will be available for 30 days.

On August 7, 2019 Medigene AG (FSE: MDG1, Frankfurt, Prime Standard), a clinical stage immuno-oncology company focusing on the development of T cell immunotherapies, reported on their business performance and financial results for the first half of 2019 (Press release, MediGene, AUG 7, 2019, View Source [SID1234538320]). In the first six months of 2019, the Company made additional advances in their immunotherapy programs and reported a significant revenue increase, primarily due to the partnerships with bluebird bio and Roivant/Cytovant. Medigene confirms the financial guidance for the fiscal year 2019.

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"In the first half of 2019, we reported on clinical progress for three TCR therapy projects. Importantly, we initiated patient treatment in our ongoing study with Medigene’s first TCR therapy, MDG1011. We also commenced preparations for the Phase I trial of our second TCR therapy, MDG1021, with Leiden University Medical Center, scheduled to start in 2020. Additionally, our partner bluebird bio announced its intention to start a Phase I clinical trial in 2020 with the first TCR from our partnership. Also, Medigene was able to present promising clinical interim results from our DC vaccine trial," said Prof. Dolores Schendel, CEO/CSO of Medigene AG. "In addition, we established an important strategic partnership with Roivant/Cytovant for cellular therapies in Asia which will enable us to bring much needed treatment alternatives to this patient population. We are very pleased with the progress we have made this year and look forward to making further advancements with our proprietary immunotherapy programs as well as with those of our partners in the coming months."

Major events since the beginning of 2019:
– In June, Medigene presented an interim analysis from its ongoing Phase I/II clinical trial with dendritic cell (DC) vaccines in acute myeloid leukemia (AML) patients at the congress of the European Hematology Association (EHA) (Free EHA Whitepaper). The completion of the ongoing trial is scheduled for the end of 2019, following a two-year treatment period.
– In May, Medigene entered into a clinical trial agreement for its second T cell receptor (TCR) immunotherapy MDG1021 with Leiden University Medical Center. The Phase I clinical trial using an HA-1-specific TCR is scheduled to start in 2020 as Medigene’s second company-sponsored clinical TCR-T trial.
– In May, Medigene’s partner bluebird bio presented preclinical data for the first TCR candidate from the Medigene collaboration. The data demonstrated a high antigen sensitivity of the MAGE-A4-TCR, with strong recognition of tumor cell lines and durable tumor elimination in a subcutaneous in vivo melanoma model. Additionally, the data showed functional responses in both CD8+ and CD4+ T cell populations, demonstrating that addition of the CD8 co-receptor will not be needed for use of this MAGE-A4-TCR in solid tumors. bluebird bio intends to commence clinical development of the TCR targeting the MAGE-A4 tumor antigen in 2020; bluebird bio may potentially combine this highly active TCR with other technologies to enhance T cell function in solid tumor microenvironments in next generation programs.
– In April, Medigene entered into a license and cooperation agreement with the Roivant group on behalf of the newly founded Cytovant Sciences for research and discovery of cell therapies in Asia. Medigene granted Cytovant exclusive licenses to develop, manufacture, and commercialize Medigene’s TCR-based immunotherapy targeting the NY-ESO-1 antigen as well as a DC vaccine targeting WT-1 and PRAME. In addition, Roivant/Cytovant and Medigene entered into a strategic collaboration and discovery agreement for TCR immunotherapies for two additional targets. Medigene will be responsible for the generation and delivery of the TCR constructs and Cytovant will ultimately assume sole responsibility for the development and commercialization of these TCR therapies; the TCRs will be tailored specifically for Asian patients. Under the terms of the transaction, Medigene received an upfront payment of USD10 million and is eligible to receive development, regulatory, and commercial milestone payments, which in aggregate could total over USD1 billion for the four products across multiple indications.
– In April, Medigene sold the remaining rights and stock of Veregen to Aresus Pharma and thereby completed its transformation into a pure-play immunotherapy company.
– In February, Medigene dosed the first patient in the Phase I/II clinical trial of Medigene’s first T cell immunotherapy (TCR-T) MDG1011 to treat acute myeloid leukemia, myelodysplastic syndrome and multiple myeloma.
– In January, Medigene licensed a co-stimulatory receptor from Helmholtz Zentrum Munich to enhance TCR therapies for solid tumors.

Key figures in the first half of 2019:
– Revenue from the core immunotherapies business grew by 47% to Eur4,926k (6M-2018: Eur3,358 k) due to the partnership with bluebird bio and a new partnership with Roivant/Cytovant.
– Total revenue increased by 33% to Eur5,640k (6M-2018: Eur4,253k).
– Research and development expenses increased as planned by 26% to Eur10,922k (6M-2018: Eur8,669 k) due to an extension of the preclinical and, in particular, the clinical development and manufacturing activities for Medigene’s immunotherapy programs.
– EBITDA loss increased by 77% to Eur13,208 k (6M-2018: Eur7,479k); the increase of EBITDA loss was 14% (Eur8,532 k) when excluding the Veregen effect in the non-core business.
– Cash and cash equivalents and time deposits were Eur65,256 k as at June 30, 2019 (December 31, 2018: Eur71,408 k).

Financial guidance 2019:
Medigene confirmed the financial guidance issued in the 3M-2019 quarterly report:
– The Company anticipates generating total revenue of Eur10 – 11m in 2019.
– Due to anticipated advances in development projects, Medigene is projecting research and development expenses of Eur24 – 29m and forecasts an EBITDA loss of Eur23 – 28m.
– This assessment does not include potential future milestone payments or cash flows from existing or future partnerships or transactions, as the timing and extent of such events depends to a large extent on external parties and therefore cannot be reliably predicted by Medigene.
– Based on its current planning, the Company has sufficient financial resources to fund business operations beyond the planning horizon of two years.

Immunotherapy Outlook:
Current Phase I/II clinical trial with Medigene’s first TCR therapy MDG1011
Medigene commenced the Phase I/II clinical trial of its TCR-based T cell therapy MDG1011 and began treating patients in the first quarter of 2019. There are currently six active study centers and Medigene anticipates opening additional sites as previously guided. In 2019, the focus of the trial will be patient recruitment in the first dosing cohorts to assess the safety and tolerability of the treatment with MDG1011.

Planned Phase I/II clinical trial with Medigene’s second TCR therapy MDG1021
Based on the Clinical Trial Agreement entered into with the Leiden University Medical Center (LUMC) in May 2019, Medigene plans to conduct a Phase I clinical trial with Medigene’s TCR therapy MDG1021, targeting the HA-1 antigen. Medigene will assess the safety, feasibility and preliminary efficacy of MDG1021 in patients with relapsed or persistent hematologic malignancies following allogeneic hematological stem cell transplantation. The study is scheduled to start in 2020 as Medigene’s second company-sponsored clinical TCR-T trial after preparation for the trial is completed.

Development of additional TCR candidates
Now that a robust platform for the discovery and characterization of new TCR candidates has been fully established, building a solid pipeline of potential TCR-development candidates is an important goal to secure future clinical programs for both internal and existing or future partners.

In 2019, in addition to the MDG1011 clinical trial, Medigene will therefore work on characterizing new TCR candidates for future clinical trials under the responsibility and funding of Medigene and collecting preclinical data to prepare further clinical TCR trials.

Optimization of future TCR therapies for solid tumors
The chimeric co-stimulator receptor (PD-1/4-1BB molecule) licensed from HMGU will be assessed in combination with Medigene’s tumor-specific T cells (TCR-Ts) in preclinical models in order to optimize future TCR therapies for solid tumors.

TCR partnerships
In addition, Medigene continues its successful collaboration with bluebird bio and expects to make further progress on TCR candidate discovery. bluebird bio announced to commence clinical development in solid tumors with the first TCR from this partnership (a TCR targeting MAGE-A4) in 2020.

Within the framework of the partnership entered into with Roivant/Cytovant, Medigene will now, together with the collaboration partner, undertake the preparations to generate TCR constructs tailored specifically to Asian patients using its proprietary TCR discovery platform.

Dendritic cell vaccines (DCs)
Medigene will continue the current Phase I/II clinical trial for DC vaccines for the treatment of acute myeloid leukemia (AML) as planned and bring it to a conclusion at the end of 2019. The final data will be available towards the end of 2019/beginning of 2020.

The full version of the quarterly statement 6M-2019 can be downloaded here: View Source

Conference call and webcast: A telephone conference (webcast) in English will be held today at 3:00 pm CET (Munich/Frankfurt) / 9:00 am EST (New York) and transmitted live via webcast. Access and transmission of the synchronized presentation slides and a recording of the presentation is available on the homepage of Medigene at View Sourcewebcasts/

On august 7, 2019 Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics, reported its results for the second quarter and provided an update on the company’s recent activities (Press release, Five Prime Therapeutics, AUG 7, 2019, View Source [SID1234538338]).

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"We are pleased that enrollment in our Phase 3 FIGHT trial continues to exceed expectations due to FGFR2b biomarker prevalence above 30% and continued strong investigator support. We are enthusiastic about the potential of bemarituzumab to be an important new medicine for patients with previously untreated, advanced gastric cancer," said Aron Knickerbocker, Chief Executive Officer of Five Prime Therapeutics. "We estimate that the FIGHT trial will reach sufficient enrollment in the coming months to support the planned, event-driven futility analysis in the first half of 2020, allowing us to pause enrollment in the fourth quarter of this year. This is consistent with our portfolio prioritization, which is currently focused on conducting the FIGHT trial, advancing the most promising FPA150 opportunities, as well as assessing safety and dose finding for FPT155."

Second Quarter 2019 Business Highlights and Milestones

Clinical Pipeline:

Bemarituzumab (anti-FGFR2b) is a first-in-class isoform-selective antibody with enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) in development as a targeted immunotherapy for tumors that overexpress FGFR2b. Bemarituzumab and mFOLFOX6 are being evaluated in combination with mFOLFOX6 in the Phase 3 FIGHT (FGFR2b Inhibition in Gastric and Gastroesophageal Junction Cancer Treatment) trial.

Enrollment in the FIGHT trial continues ahead of projections due to FGFR2b biomarker prevalence that has remained steady at more than 30%, strong clinical trial execution, and continued support and enthusiasm from clinical investigators.
The company plans to conduct an early futility analysis for the FIGHT trial during the first half of 2020. The purpose of the futility analysis is to ensure the trial is adequately powered to detect an overall survival benefit at full enrollment.
Consistent with its portfolio prioritization and given the higher than expected enrollment rate, the company will pause enrollment in the FIGHT trial when sufficient patients have been enrolled in the trial to support the planned futility analysis. The company expects the pause in enrollment to occur during the fourth quarter of 2019.
FPA150 (anti-B7-H4) is a first-in-class B7-H4 antibody designed to target tumor cells by enhancing killing of B7-H4 overexpressing tumors through ADCC and by blocking B7-H4 from sending an inhibitory signal to CD8 T cells. B7-H4 is frequently overexpressed in breast, ovarian and endometrial cancers.

Five Prime will present a poster at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress that will include preliminary FPA150 data from the monotherapy Phase 1b expansion cohorts at the 20 mg/kg dose in patients with breast, ovarian or endometrial cancers that overexpress B7-H4 and early safety data from the Phase 1a lead-in testing FPA150 in combination with Keytruda.
The company presented preliminary monotherapy safety data from the dose escalation and exploration portions of the Phase 1a/1b trial of FPA150 in patients with advanced solid tumors at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.
FPT155 (CD80-Fc) is a first-in-class CD80-Fc fusion protein that uses the binding interactions of soluble CD80 to directly engage CD28 to enhance its co-stimulatory T cell activity without inducing super agonism and to block CTLA-4 from competing for endogenous CD80, allowing CD28 signaling to prevail in T cell activation in the tumor microenvironment.

Enrollment is proceeding according to plan in the dose escalation portion of the Phase 1a/1b trial, with six dose level cohorts enrolled and dose escalation continuing.
An abstract was submitted for the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, where the company expects to present safety and pharmacokinetic data from the Phase 1a dose escalation portion of the ongoing Phase 1a/1b trial.
Cabiralizumab (anti-CSF1R) is an antibody that inhibits CSF1R and has been shown to block the activation and survival of tumor-associated macrophages. Pursuant to a worldwide collaboration agreement, Bristol-Myers Squibb (BMS) has an exclusive worldwide license for the development and commercialization of cabiralizumab, and Five Prime retains the rights to a U.S. co-promotion option.

The next anticipated event is completion of enrollment in the Phase 2 trial testing the combination of cabiralizumab with Opdivo (nivolumab) with and without chemotherapy in approximately 160 patients with locally advanced or metastatic pancreatic cancer that has progressed during or after one line of chemotherapy.
BMS-986258 (anti-TIM-3) is a fully-human monoclonal antibody targeting TIM-3 (T cell immunoglobulin and mucin domain-3), an immune checkpoint receptor that may limit the duration and magnitude of T cell responses. This is the first clinical candidate from the discovery collaboration between Five Prime and BMS that includes targets in three immune checkpoint pathways.

The Phase 1/2 clinical trial continues to progress, and, in July, the expected size of the trial was increased from 308 to 383 patients.
Corporate Highlights

During the second quarter, the company announced the appointment of Carol Schafer and Lori Lyons-Williams to its board of directors. The company also announced the departure of Dr. Sheila Gujrathi from the board.
Summary of Financial Results and Guidance:

Cash Position: Cash, cash equivalents and marketable securities totaled $214.1 million as of June 30, 2019, compared to $237.0 million as of March 31, 2019. The decrease in cash, cash equivalents and marketable securities was primarily attributable to quarterly operating expenses that exceeded quarterly revenues.

Revenue: Collaboration and license revenue for the second quarter of 2019 decreased by $4.3 million, or 56.6%, to $3.3 million from $7.6 million for the second quarter of 2018. This decrease was primarily related to lower collaboration revenues from BMS due to a reduction in activities in the Phase 1a/1b trial of the combination of cabiralizumab and nivolumab and the completion of the research term under the immuno-oncology research collaboration in March 2019.

R&D Expenses: Research and development expenses for the second quarter of 2019 decreased by $4.0 million, or 12.0%, to $29.4 million from $33.4 million for the second quarter of 2018. This decrease was primarily due to lower compensation costs, as well lower manufacturing costs related to FPT155 drug production and lower diagnostic costs related to the FIGHT trial. These cost reductions were partially offset by higher CRO costs that were related to strong patient enrollment and the opening of new clinical trial sites.

G&A Expenses: General and administrative expenses for the second quarter of 2019 decreased by $0.1 million, or 1%, to $9.7 million from $9.8 million for the second quarter of 2018. The decrease was primarily due to decreased use of consultants in a number of functions across the company.

Net Loss: Net loss for the second quarter of 2019 was $34.4 million, or $0.99 per basic and diluted share, compared to a net loss of $34.1 million, or $0.99 per basic and diluted share, for the second quarter of 2018.

Shares Outstanding: Weighted average shares outstanding for the second quarter of 2019 was 34,909,479 as of June 30, 2019.

Cash Guidance: Five Prime expects full-year 2019 net cash used in operating activities to be between $117 and $122 million and estimates ending 2019 with cash, cash equivalents and marketable securities between $148 and $153 million.

Conference Call Information

Five Prime will host a conference call and live audio webcast today at 4:30 p.m. (ET) / 1:30 p.m. (PT) to discuss its financial results and provide a corporate update. To participate in the conference call, please dial (877) 878-2269 (domestic) or (253) 237-1188 (international) and refer to conference ID 3575436. To access the live webcast please visit the "Events & Presentations" page under the "Investors" tab on Five Prime’s website at www.fiveprime.com. An archived copy of the webcast will be available on Five Prime’s website beginning approximately two hours after the conference call. Five Prime will maintain an archived replay of the webcast on its website for at least 30 days after the conference call.

On August 7, 2019 Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) reported financial results for the quarter ended June 30, 2019 (Press release, Sunesis, AUG 7, 2019, View Source [SID1234538367]). Loss from operations for the three and six months ended June 30, 2019 was $6.2 million and $11.9 million. As of June 30, 2019, cash and cash equivalents, restricted cash, and marketable securities totaled $17.7 million. Subsequent to the end of the quarter, the Company raised approximately $25.9 million in net proceeds from an underwritten offering.

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"We continue to make progress in the Phase 1b/2 trial of our non-covalent BTK inhibitor vecabrutinib in chronic lymphocytic leukemia and other B-cell malignancies. At the annual European Hematology Association (EHA) (Free EHA Whitepaper) meeting in June, we presented preliminary data demonstrating vecabrutinib’s well-tolerated safety profile and evidence of clinical activity," said Dayton Misfeldt, Interim Chief Executive Officer of Sunesis. "More recently, in July, we announced completion of the safety evaluation period for the 200mg cohort, which continues to support the favorable safety profile with no drug-related serious adverse events experienced to date. We look forward to further defining the profile of vecabrutinib in the current study as we prepare for the upcoming Phase 2. We plan on sharing the next clinical update on the study at the annual American Society of Hematology (ASH) (Free ASH Whitepaper) meeting later this year."

"In addition, we strengthened our balance sheet by completing an equity offering in July with leading biotechnology investors, as well as refinancing our previous loan with a new facility from Silicon Valley Bank in April. The proceeds from our recent offering extends our cash runway through key milestones including the initiation of the Phase 2 portion of the trial."

Recent Highlights

Advanced Phase 1b/2 Trial of Vecabrutinib into 300 mg Cohort. In July 2019, Sunesis opened enrollment in the 300 mg cohort in the Phase 1b/2 trial of its non-covalent BTK inhibitor vecabrutinib in adults with relapsed/refractory chronic lymphocytic leukemia (CLL) and other B-cell malignancies.

Presented Preliminary Data at the EHA (Free EHA Whitepaper) Annual Meeting. In June 2019, Sunesis presented preliminary data from the ongoing vecabrutinib clinical trial at the 24th Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) in Amsterdam. The promising data builds upon vecabrutinib’s safety, activity, pharmacokinetic, and pharmacodynamic profile.

Completion of Public Offering. In July 2019, Sunesis completed underwritten public offerings of shares of its common stock and Series F convertible preferred stock with net proceeds of approximately $25.9 million. The offerings attracted participation from leading biotechnology investors and will allow Sunesis to advance vecabrutinib through important clinical milestones as the ongoing dose-escalation study explores potentially active dose levels.

Secured $5.5 Million Loan. In April 2019, the Company entered into a $5.5 million loan agreement with Silicon Valley Bank (SVB), allowing the Company to retire its existing loan. The new agreement allows the Company to defer any principal repayment on the new loan for more than 18 months, with interest-only payments through 2020 and principal repayment over 24 months beginning in 2021. The new loan also has a lower interest rate and was used to repay the Company’s prior loan.

Announced Executive Promotions. In July 2019, Sunesis promoted Judy Fox, Ph.D. to Chief Scientific Officer, Executive Vice President, Research & Development, and Parvinder (Par) S. Hyare to Senior Vice President, Commercial. We look forward to their leadership as we prepare for the next stage of the Company’s growth.

Financial Highlights

Cash and cash equivalents, restricted cash, and marketable securities totaled $17.7 million as of June 30, 2019, as compared to $13.7 million as of December 31, 2018. This capital, plus the approximately $25.9 million in net proceeds from the July 2019 public offerings, is expected to fund the Company through the initiation of the Phase 2 portion of the ongoing vecabrutinib Phase 1b/2 trial. The increase of $4.0 million was primarily due to $19.0 million net proceeds from issuance of common and preferred stock, and $5.5 million proceeds from SVB Loan Agreement, offset by $13.0 million net cash used in operating activities and $7.5 million used in principal payments to repay the Company’s prior loan.

Research and development expense was $3.7 million and $6.9 million for the three and six months ended June 30, 2019, as compared to $3.8 million and $7.7 million for the same periods in 2018. The decreases between the comparable periods were primarily due to a decrease in salary and personnel expenses due to lower headcount, decrease in professional services related to higher expenses incurred in the first half of 2018 for the start-up costs of the Phase 1b/2 trial for vecabrutinib, offset by an increase in clinical expenses related to the preparation for the Phase 2 portion of the ongoing clinical trial of vecabrutinib.

General and administrative expense was $2.5 million and $5.0 million for the three and six months ended June 30, 2019, as compared to $2.8 million and $6.2 million for the same periods in 2018. The decreases between the comparable periods were primarily due to a decrease in salary and personnel expenses due to lower headcount and stock-based compensation and a decrease in professional services expenses due to lower legal and vosaroxin patent expenses.

Interest expense was $0.1 million and $0.4 million for the three and six months ended June 30, 2019, as compared to $0.3 million and $0.6 million for the same periods in 2018. The decreases in interest expense from both periods resulted from a lower interest rate on a lower principal amount under the SVB Loan Agreement.

Cash used in operating activities was $13.0 million for the six months ended June 30, 2019, as compared to $12.4 million for the same period in 2018. Net cash used in the six months ended June 30, 2019, resulted primarily from the net loss of $12.1 million, partially offset by adjustments for non-cash items of $0.9 million and changes in operating assets and liabilities of $1.8 million. Net cash used in the six months ended June 30, 2018, resulted primarily from the net loss of $14.1 million, partially offset by adjustments for non-cash items of $1.6 million and changes in operating assets and liabilities of $0.1 million.

Sunesis reported loss from operations of $6.2 million and $11.9 million for the three and six months ended June 30, 2019, as compared to $6.6 million and $13.7 million for the same periods in 2018. Net loss was $6.2 million and $12.1 million for the three and six months ended June 30, 2019, as compared to $6.8 million and $14.1 million for the same periods in 2018.

Conference Call Information

Sunesis will host a conference today at 4:30 p.m. Eastern Time. The call can be accessed by dialing (844) 296-7720 (U.S. and Canada) or (574) 990-1148 (international) and entering passcode 2686126. To access the live audio webcast, or the subsequent archived recording, visit the "Investors and Media – Calendar of Events" section of the Sunesis website at www.sunesis.com. The webcast will be recorded and available for replay on the Company’s website for two weeks.