On March 8, 2019 Conatus Pharmaceuticals Inc. (Nasdaq:CNAT) reported financial results for the fourth quarter and full year ended December 31, 2018, and provided updates on its development programs (Filing, 8-K, Conatus Pharmaceuticals, MAR 8, 2019, View Source [SID1234534163]).

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Program Updates
The company is conducting three double-blind, placebo-controlled Phase 2b clinical trials in collaboration with Novartis – the EmricasaN, a Caspase inhibitOR, for Evaluation (ENCORE) trials, designed to evaluate emricasan, a first-in-class pan-caspase inhibitor, in patients with liver fibrosis or cirrhosis caused by nonalcoholic steatohepatitis (NASH).

The ENCORE-NF (for NASH Fibrosis) clinical trial, initiated in the first quarter of 2016, has enrolled approximately 330 patients with baseline NASH Clinical Research Network (CRN) fibrosis scores of F1 (up to 20% of enrolled patients), F2, and F3. The primary endpoint is a biopsy-based one point or greater improvement in NASH CRN fibrosis score compared with placebo at week 72, with no worsening of steatohepatitis. The primary endpoint will be evaluated and can be achieved in either of two prospectively defined patient populations – the F1/F2/F3 population or the F2/F3 population. Either of these populations may be used in a future Phase 3 trial. The company believes that the ENCORE-NF analysis plan has the potential to facilitate discussions with regulatory authorities regarding its use as a study to support regulatory approval. Top-line results from ENCORE-NF are expected in the first half of 2019.

The ENCORE-LF (for Liver Function) clinical trial, initiated in the second quarter of 2017, has enrolled approximately 210 patients with stable decompensated NASH cirrhosis. The primary endpoint is event-free survival, which is a composite of all-cause mortality, new decompensation events, or ≥4 points progression in Model for End-stage Liver Disease (MELD) score. Enrollment was completed in the first quarter of 2019. Top-line results triggered by reaching a prespecified number of events are expected in mid-2019.

The ENCORE-PH (for Portal Hypertension) clinical trial, initiated in the fourth quarter of 2016, enrolled 263 patients with compensated or early decompensated NASH cirrhosis and severe portal hypertension. The trial’s primary endpoint was change in mean hepatic venous pressure gradient (HVPG) from baseline to Week 24 in any of three emricasan dosing groups compared with placebo. Top-line results were reported in December 2018 showing HVPG trends consistently favoring emricasan compared with placebo in the overall population but not meeting the primary endpoint. Post hoc analyses showed clinically meaningful treatment effects for emricasan compared with placebo and a trend toward clinical benefit in the prespecified subpopulation of compensated patients, with the greatest improvement in compensated patients with baseline HVPG ≥16 mmHg. Patients had the option to continue on their assigned doses of treatment or placebo in a double-blind 24-week extension period to evaluate longer term safety, liver function and clinical outcomes. Results following the extension period are expected in mid-2019.
In its internal development program, the company has assembled a proprietary portfolio of orally active molecules that inhibit the NLRP3 inflammasome pathway and the activation of the potent inflammatory cytokine IL-1b. Inhibition of IL-1b is a clinically validated approach to treating inflammatory diseases, with several injectable biologic products using that mechanism of action already on the market. The NLRP3 inflammasome pathway is dependent upon caspase 1, which activates IL-1b. Caspase 1 occupies a uniquely central position in the inflammasome pathway, and the company has leveraged its scientific expertise in caspase research and development to design potent, selective and orally bioavailable inhibitors of caspase 1. Excess IL-1b has been linked to a variety of diseases including rare genetic inflammatory diseases, cancer, liver and other gastrointestinal diseases, and cardiovascular diseases.

The company is announcing today the selection of its first internally developed product candidate, CTS-2090, based on its preclinical profile, including high selectivity for caspase 1, and drug-like properties. CTS-2090 is currently in preclinical development and IND-enabling studies, with an initial clinical trial expected to begin by the first half of 2020. Additional details will be discussed in the conference call and webcast scheduled for 4:30 p.m. ET today (information below).

Financial Results
The net loss for the fourth quarter of 2018 was $3.9 million compared with $4.4 million for the fourth quarter of 2017. The net loss for the full year 2018 was $18.0 million compared with $17.4 million for the full year 2017.

Total revenues were $7.4 million for the fourth quarter of 2018 compared with $8.8 million for the fourth quarter of 2017, and $33.6 million for the full year 2018 compared with $35.4 million for the full year 2017. Total revenues consisted of collaboration revenues related to the Novartis agreement. The decreases in revenues for both periods were primarily due to lower emricasan-related research and development expenses resulting in corresponding lower revenues related to the Novartis agreement, partially offset by the effects of adopting the ASC 606 revenue recognition standard.

Research and development expenses were $8.9 million for the fourth quarter of 2018 compared with $10.9 million for the fourth quarter of 2017. Research and development expenses were $41.4 million for the full year 2018 compared with $43.2 million for the full year 2017. The decreases in both periods were primarily due to lower costs related to the ENCORE clinical trials, as well as lower costs related to emricasan manufacturing activities, partially offset by higher costs related to new product candidate development.

General and administrative expenses were $2.5 million for the fourth quarter of 2018 compared with $2.3 million for the fourth quarter of 2017. General and administrative expenses were $10.5 million for the full year 2018 compared with $9.7 million for the full year 2017. The increases in general and administrative expenses for both periods were primarily due to higher personnel costs and recognition of deferred collaboration costs due to adoption of the new revenue recognition standard.

In December 2018, the company, at its option, converted the outstanding principal plus accrued and unpaid interest of the Novartis note into shares of the company’s common stock. Cash, cash equivalents and marketable securities were $40.7 million at December 31, 2018, compared with $74.9 million at December 31, 2017, and a projected year-end 2019 balance, without including any potential milestone payments under the Novartis collaboration, of between $10 million and $15 million.

Conference Call and Audio Webcast
Conatus will host a conference call and audio webcast at 4:30 p.m. ET today to discuss the financial results and provide a corporate update. To access the conference call, please dial 877-312-5857 (domestic) or 970-315-0455 (international) at least five minutes prior to the start time and refer to conference ID 3249458. A live and archived audio webcast of the call will also be available in the Investors section of the Conatus website at www.conatuspharma.com.

On March 7, 2019 Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported business and financial highlights for the fourth quarter and year ended December 31, 2018 (Press release, Celldex Therapeutics, MAR 7, 2019, View Source [SID1234534059]). The Company will host a conference call at 4:30 p.m. ET today to provide an update on its pipeline and business.

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"Celldex made important progress across our pipeline in the fourth quarter, continuing to execute on our ongoing CDX-1140 and CDX-3379 clinical programs and advancing earlier stage assets that we believe have the potential to play an important role in the future of the organization," said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics.

"Data from both the CDX-1140 and MerTK programs were presented at SITC (Free SITC Whitepaper) in November and we look forward to providing an update on CDX-1140 at AACR (Free AACR Whitepaper) in early April. In the ongoing Phase 1 study of CDX-1140 in solid tumors and B cell lymphomas, we have completed six of the potential eight monotherapy dose levels and the first of six potential combination dose levels with CDX-301 and are pleased with the safety and biological profile we have observed to date. We also continue to follow patients in the Phase 2 study of CDX-3379 in advanced head and neck squamous cell cancer and plan to present data from this study at a medical meeting in the coming months. We believe 2019 will be an important year for Celldex with data anticipated across multiple programs," concluded Marucci.

Recent Highlights:

Enrollment continues in the Phase 1 dose-escalation study of CDX-1140 with recurrent, locally advanced or metastatic solid tumors and B cell lymphomas. CD40 has long been an important target for immunotherapy, as it plays a critical role in the activation of innate and adaptive immune responses; however, effectively balancing systemic dosing and safety has proven challenging to date for CD40-activating therapeutics. CDX-1140 is a unique, potent CD40 agonist that Celldex believes has the potential to successfully balance systemic doses for good tissue and tumor penetration with an acceptable safety profile. Interim data from the ongoing study have been accepted for presentation on Tuesday, April 2, 2019 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting.

Data to date from the six completed dosing cohorts (0.01, 0.03, 0.09, 0.18, 0.36 and 0.72 mg/kg) suggest that CDX-1140 is exhibiting a desirable safety profile and demonstrating clear signs of biological activity based on biomarker analysis. The seventh monotherapy cohort at 1.5 mg/kg is currently being enrolled, along with the combination therapy cohort of CDX-1140 (0.18 mg/kg) with CDX-301. CDX-301 is a dendritic cell growth factor being utilized as a priming agent to increase the number of cells available to respond to CDX-1140. In addition, Celldex is evaluating the potential for combination with varlilumab, especially in lymphomas which co-express CD40 and CD27 receptors.

Early data from the Phase 1 study were presented in November 2018 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting. Dose dependent biological effects consistent with CD40-mediated immune activation were reported; CDX-1140 was well tolerated and no MTD had been reached.

Enrollment is complete in the first stage of the Phase 2 study (n=13) of CDX-3379 in advanced head and neck squamous cell cancer in combination with Erbitux in Erbitux-resistant patients who have been previously treated with or are ineligible for checkpoint therapy. According to the study’s Simon two-stage design, if at least one patient achieves an objective response in the first stage, enrollment may progress to the second stage. While a confirmed complete response has been documented, Celldex will conduct a comprehensive review, including the full data set, before making decisions on future development, as patients are still undergoing treatment and are eligible for evaluation. Celldex plans to present updated data from the study at a future medical meeting in 2019.

Celldex continues to advance a robust preclinical portfolio. Data from the Company’s MerTK antibody program were presented in November 2018 at the SITC (Free SITC Whitepaper) Annual Meeting and have been accepted for presentation at the AACR (Free AACR Whitepaper) meeting on Monday, April 1, 2019. MerTK is emerging as a promising target for cancer immunotherapy; its expression in innate immune cells is believed to negatively regulate immune responses and genetic removal of MerTK renders mice resistant to some tumors. Data from the Company’s bispecific program, CDX-527, have also been accepted for presentation at AACR (Free AACR Whitepaper) on Monday, April 1, 2019. CDX-527 uses Celldex’s proprietary highly active anti-PD-L1 and CD27 human antibodies to couple CD27 co-stimulation with blockade of the PD-L1/PD-1 pathway.
Fourth Quarter and Twelve Months 2018 Financial Highlights and 2019 Guidance

NASDAQ Compliance: Celldex completed a one for fifteen reverse stock split, which became effective February 8, 2019. On February 11, 2019, Celldex common stock began trading on a split-adjusted basis on the NASDAQ Capital Market. On February 26, 2019, Celldex received formal notice from NASDAQ that the Company had regained compliance with the minimum $1.00 bid price requirement. The share and per share amounts below reflect the reverse stock split.

Cash Position: Cash, cash equivalents and marketable securities as of December 31, 2018 were $94.0 million compared to $105.6 million as of September 30, 2018. The decrease was primarily driven by fourth quarter cash used in operating activities of $15.4 million, of which $1.4 million were glembatumumab vedotin-related payments, partially offset by $3.6 million in net proceeds from sales of common stock under the Cantor agreement. At December 31, 2018, Celldex had 12.0 million shares outstanding.

Revenues: Total revenue was $1.8 million in the fourth quarter of 2018 and $9.5 million for the year ended December 31, 2018, compared to $3.5 million and $12.7 million for the comparable periods in 2017. The decrease in revenue was primarily due to lower contract revenue from the International AIDS Vaccine Initiative and Frontier Biotechnologies.

R&D Expenses: Research and development (R&D) expenses were $11.2 million in the fourth quarter of 2018 and $66.4 million for the year ended December 31, 2018, compared to $23.5 million and $96.2 million for the comparable periods in 2017. The decrease in R&D expenses was primarily due to lower clinical trial, personnel and contract manufacturing costs.

G&A Expenses: General and administrative (G&A) expenses were $4.3 million in the fourth quarter of 2018 and $19.3 million for the year ended December 31, 2018, compared to $5.9 million and $25.0 million for the comparable periods in 2017. The decrease in G&A expenses was primarily due to lower personnel and commercial planning costs.

Intangible Asset and Goodwill Impairments: During the year ended December 31, 2018, the Company recorded $18.7 million in non-cash impairment charges related to fully impaired glemba-related intangible assets and $91.0 million in goodwill impairment charges as the carrying value of the Company’s net assets exceeded the Company’s fair value by an amount in excess of the goodwill asset.

Changes in Fair Value Remeasurement of Contingent Consideration: During the year ended December 31, 2018, the Company recorded a $29.6 million gain on the fair value remeasurement of contingent consideration related to the Kolltan acquisition primarily due to discontinuation of the glembatumumab vedotin and CDX-014 programs and updated assumptions for the varlilumab and anti-KIT programs.

Net Loss: Net loss was $9.4 million, or ($0.81) per share, for the fourth quarter of 2018 and $151.2 million, or ($14.48) per share, for the year ended December 31, 2018, compared to a net loss of $3.8 million, or ($0.42) per share, and $93.0 million, or ($10.86) per share, for the comparable periods in 2017.

Financial Guidance: Celldex believes that the cash, cash equivalents and marketable securities at December 31, 2018, combined with the anticipated proceeds from future sales of common stock under the Cantor agreement, are sufficient to meet estimated working capital requirements and fund planned operations through 2020. This could be impacted if Celldex elects to pay Kolltan contingent milestones, if any, in cash.

Webcast and Conference Call

Celldex executives will host a conference call at 4:30 p.m. ET today to discuss financial and business results and to provide an update on key 2019 objectives. The conference call will be webcast live over the internet and can be accessed by going to the "Events & Presentations" page under the "Investors & Media" section of the Celldex Therapeutics website at www.celldex.com. The call can also be accessed by dialing (866) 743-9666 (within the United States) or (760) 298-5103 (outside the United States). The passcode is 9948977.

A replay of the call will be available approximately two hours after the live call concludes through March 14, 2019. To access the replay, dial (855) 859-2056 (within the United States) or (404) 537-3406 (outside the United States). The passcode is 9948977. The webcast will also be archived on the Company’s website.

On March 7, 2019 GlycoMimetics, Inc. (Nasdaq: GLYC) reported that Chief Executive Officer Rachel King will provide a company overview at the Cowen and Company 39th Annual Health Care Conference in Boston, on Tuesday, March 12, 2019, at 9:20 a.m. ET (Press release, GlycoMimetics, MAR 7, 2019, https://ir.glycomimetics.com/news-releases/news-release-details/glycomimetics-present-cowen-and-company-39th-annual-health-care [SID1234534096]).

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To access the live webcast and subsequent archived recordings for the presentation, please visit the GlycoMimetics website at www.glycomimetics.com.

On March 7, 2019 Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company focused on the development and commercialization of precisely targeted oncology therapies, reported financial results for the fourth quarter and year ended December 31, 2018, and provided a business update (Press release, Corvus Pharmaceuticals, MAR 7, 2019, View Source [SID1234534121]).

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"We continue to make significant progress in the clinic both with CPI-444 and with CPI-006, both as monotherapies and in combination with other agents and each other, positioning Corvus as a leader in the development of medicines that modulate the adenosine pathway," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "In addition, we recently discovered an adenosine gene signature that we believe sheds important insight on the mechanisms of action for CPI-444 and CPI-006, and provides a biomarker that could be vital in future clinical trials. The FDA also recently cleared our IND for CPI-818, an ITK inhibitor that represents a novel approach for the treatment of T-cell lymphomas and that will mark our third product candidate in the clinic."

Recent Achievements

CPI-444: A2A Receptor Antagonist of Adenosine

Continued enrollment of up to 50 patients with renal cell cancer (RCC) in an amended Phase 1b/2 clinical trial evaluating CPI-444 administered alone and in combination with Genentech’s Tecentriq (atezolizumab), an anti-PD-L1 antibody.
Continued enrollment of up to 60 patients with non-small cell lung cancer (NSCLC) in a Phase 1b/2 trial being conducted by Genentech as part of their MORPHEUS platform. The study is evaluating CPI-444 and Tecentriq in patients who have failed no more than two prior regimens.
CPI-444 preclinical study results were published in and featured on the cover of the October issue of the journal Cancer Immunology Research, which is an official journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper). The results demonstrated that CPI-444 induces dose dependent anti-tumor responses as a monotherapy and in combination with anti-PD-1, anti-PD-L1 and anti-CTLA-4 therapies.
Presented updated results from the original Phase 1/1b trial of CPI-444 at the SITC (Free SITC Whitepaper) 33rd Annual Meeting covering 33 patients receiving CPI-444 as a monotherapy and 35 patients receiving CPI-444 in combination with Tecentriq. The results showed disease control for more than 6 months was achieved in 17 percent and 35 percent of patients receiving monotherapy and combination therapy, respectively. In addition, for patients receiving combination therapy, 11 percent experienced a confirmed partial response (PR; as determined by RECIST criteria). For patients receiving monotherapy, one patient experienced a confirmed PR and one experienced an unconfirmed PR. Several patients in both groups experienced tumor regression not meeting the PR criteria.
Presented new data on the "adenosine gene signature" (AdenoSig), a biomarker associated with patient response to therapy with CPI-444, in a poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress. Presented updated AdenoSig data at the Immuno-Oncology 360° Conference that showed a relationship between this biomarker and angiogenesis gene expression data (or angiogenesis signature). These data suggest that patients with a high AdenoSig are potentially more likely to respond to treatment with CPI-444 and less likely to respond to VEGFR inhibitors.
CPI-006: Anti-CD73 Antibody

Continued enrollment of up to 350 patients with advanced cancer in a Phase 1/1b clinical trial evaluating CPI-006 as a single agent and in combination with either CPI-444 or an anti-PD-1. Enrollment is now in the dose escalation phase for CPI-006 administered as a single agent and in combination with CPI-444.
Presented updated biomarker data at the Immuno-Oncology 360° Conference that showed CPI-006 given as a monotherapy activated B cells, led to a redistribution of these cells and led to changes in other immune cells (e.g., changes in T helper to T suppressor ratios). These data are consistent with immune stimulation induced by CPI-006. It was also reported that CPI-006 reacted with an epitope on CD73 that led to blockade of adenosine production and expression of lymphocyte activation antigens that are independent of adenosine.
CPI-818: A small molecule ITK inhibitor

Preclinical data on CPI-818 was presented at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Molecular Targets and Cancer Therapeutics Symposium, in November 2018. Such preclinical data demonstrated that orally-administered CPI-818 produced tumor regression in companion dogs with spontaneous, naturally occurring T-cell lymphomas, without significant toxicity.
The Company plans to evaluate CPI-818, an interleukin-2-inducible kinase (ITK) inhibitor, in a Phase 1/1b study in patients with several types of T-cell lymphomas, including peripheral T-cell lymphoma (PTCL), cutaneous T-cell lymphoma (CTCL) and others, with patient enrollment planned in March 2019.
Corporate Updates

Appointed Linda S. Grais, M.D., J.D., to the Company’s Board of Directors, replacing Peter Moldt, Ph.D., who served as a director since January 2015 and resigned his position.
Appointed Mehrdad Mobasher, M.D., M.P.H., as Vice President and Chief Medical Officer to oversee the Company’s pipeline of precisely-targeted investigational oncology therapies.
Financial Results

As of December 31, 2018, Corvus had cash, cash equivalents and marketable securities totaling $114.6 million. This compared to cash, cash equivalents and marketable securities of $90.1 million at December 31, 2017. The Company expects net cash utilization of $43 million to $47 million in 2019.

Research and development expenses for the three months and full year ended December 31, 2018 totaled $8.4 million and $38.6 million, respectively, compared to $9.7 million and $46.3 million for the same periods in 2017. In the fourth quarter of 2018, the decrease of $1.3 million was primarily due to a $2.8 million decrease in CPI-444 costs, partially offset by an increase of $1.2 million in CPI-818 costs. For the full year 2018, the decrease of $7.7 million was primarily due to a $12.8 million decrease in CPI-444 costs, partially offset by an increase of $2.9 million in CPI-818 costs and a $1.8 million increase in personnel and outside research costs.

The net loss for the three months and year ended December 31, 2018 was $10.5 million and $46.9 million, respectively, compared to $11.9 million and $55.7 million for the same periods in 2017. Total stock compensation expense for the three months and year ended December 31, 2018 was $1.8 million and $7.1 million, compared to $1.7 million and $6.2 million for the same periods in 2017.

On March 7, 2019 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that it is scheduled to speak at the Barclays Global Healthcare Conference in Miami. Mark Guinan, Executive Vice President and CFO will discuss the company’s vision, goals and two-point strategy to accelerate growth and drive operational excellence (Press release, Quest Diagnostics, MAR 7, 2019, View Source [SID1234534137]). The presentation is scheduled for Tuesday, March 12, 2019 at 10:15 a.m. Eastern Time.

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The presentation will be webcast live during the conference and will be available on the company’s investor relations page which can be accessed at ir.QuestDiagnostics.com. In addition, the archived webcast will be available within 24 hours after the conclusion of the live event and will remain available until April 11, 2019.