On March 8, 2019 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a physician-led biopharmaceutical company focused on dermatological and immuno-inflammatory diseases, reported it will report financial results for the fourth quarter and full year 2018, Monday, March 18th, before U.S. financial markets open (Press release, Aclaris Therapeutics, MAR 8, 2019, View Source [SID1234534135]).

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Management will conduct a conference call at 8:00 AM ET to discuss Aclaris’ financial results and provide a general business update. The conference call will be webcast live over the Internet and can be accessed by logging on to the "Investors" page of the Aclaris Therapeutics website, www.aclaristx.com, prior to the event. A replay of the webcast will be archived on the Aclaris Therapeutics website for 30 days following the call.

To participate on the live call, please dial (844) 776-7782 (domestic) or (661) 378-9535 (international), and reference conference ID 9765869prior to the start of the call.

On March 8, 2018 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health," the "Company" or the "Offeror") reported the results to date of its pending cash tender offers (collectively, the "Tender Offers," and each offer to purchase a series of notes individually, a "Tender Offer") to purchase up to $1,500,000,000 aggregate purchase price (the "Aggregate Maximum Purchase Amount") of its outstanding notes listed in the table below (collectively, the "Notes"), as well as the anticipated early settlement date for the Tender Offers on March 11, 2019 (the "Early Settlement Date") (Press release, Valeant, MAR 8, 2019, View Source [SID1234534161]).

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In conjunction with the Tender Offers, the Company also commenced a solicitation of consents (the "Solicitation," and, together with the Tender Offers, the "Tender Offers and Solicitation") to certain proposed amendments to the indenture governing its 5.625% Senior Notes due 2021 (the "2021 Notes") to eliminate substantially all of the restrictive covenants and events of default and related provisions contained in the indenture under which the 2021 Notes were issued (the "Proposed Amendments"). No amendments to the indentures governing the 5.50% Senior Notes due 2023 (the "5.50% Notes") and 5.875% Senior Notes due 2023 (the "5.875% Notes" and, together with the 5.50% Notes, the "2023 Notes") are being sought. The terms and conditions of the Tender Offers and the Solicitation are described in an Offer to Purchase and Consent Solicitation Statement dated Feb. 22, 2019 (as it may be amended or supplemented from time to time, the "Statement") and the related Letter of Transmittal and Consent. All terms and conditions of the Tender Offers and the Solicitation, as amended by the Company’s news release dated Feb. 22, 2019, announcing the upsize of the Tender Offers, remain unchanged as set forth in the Statement.

The following table sets forth the aggregate principal amounts of each series of Notes and related consents that were tendered and not withdrawn on or prior to 5:00 p.m., New York City time, on March 7, 2019 (such date and time with respect to a Tender Offer and the Solicitation, as it may be extended for such Tender Offer and the Solicitation, the "Early Tender Date"), the aggregate principal amount of Notes expected to be accepted for purchase on the Early Settlement Date and the approximate proration factor with respect to the 2023 Notes.

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.