On March 7, 2019 NuCana plc (NASDAQ: NCNA) reported financial results for the fourth quarter and year ended December 31, 2018 and provided an update on its extensive clinical program with its transformative ProTide therapeutics (Press release, Nucana BioPharmaceuticals, MAR 7, 2019, View Source [SID1234534063]).

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As of December 31, 2018, NuCana had cash and cash equivalents of £77.0 million compared to £78.4 million as of September 30, 2018 and £86.7 million as of December 31, 2017. NuCana reported a loss of £3.6 million for the quarter ended December 31, 2018, compared to £5.0 million for the quarter ended December 31, 2017 as the Company continued to advance its various clinical programs. Net loss for the year ended December 31, 2018 was £13.8 million, compared to a net loss of £23.1 million for the year ended December 31, 2017. Basic and diluted loss per share was £0.11 for the quarter and £0.43 for the year ended December 31, 2018, compared to £0.16 per share for the comparable quarter and £0.89 on a year-over-year basis in 2017.

NuCana believes its current cash and cash equivalents will be sufficient to fund operations into 2021. In addition to continuing or completing the ongoing clinical studies, NuCana’s current cash and cash equivalents will enable the following:

Open a Phase III study of Acelarin in combination with cisplatin in patients with advanced or metastatic biliary tract cancer;

Initiate a Phase II/III study of Acelarin in combination with a platinum agent for patients with ovarian cancer; and

Initiate a Phase II/III clinical study of NUC-3373 in combination with other agents for patients with colorectal cancer.

"2018 has been another very productive year for NuCana highlighted by several encouraging clinical data presentations for Acelarin and NUC-3373," said Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer. "We began the year by announcing interim data at ASCO (Free ASCO Whitepaper)-GI from the ongoing Phase Ib study of Acelarin plus cisplatin for patients with advanced biliary tract cancer, which showed a 50% response rate, approximately doubling the response rate seen with the standard of care, gemcitabine plus cisplatin, in this patient population. At the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2018 Congress in October, we announced that the second cohort from this study maintained a 50% response rate. In addition, results showed the combination was well-tolerated and several patients achieved significant reductions in their tumor volume as well as further tumor shrinkage over time."

Mr. Griffith continued: "Additionally, in October we announced at ESMO (Free ESMO Whitepaper) interim data from an ongoing Phase I study of our second ProTide, NUC-3373, a transformation of the active anti-cancer metabolite of 5-fluorouracil (5-FU), in patients with advanced solid tumors who had exhausted all current standards of care. Notably, three patients achieved stable disease lasting more than nine months at the time of data cutoff and, importantly, no patients developed hand-foot syndrome, which is a debilitating side effect associated with fluoropyrimidine therapy."

Mr. Griffith added: "In addition to the clinical successes of our first two ProTides, we expect to enroll the first patients with advanced solid tumors in the Phase I clinical study of our third ProTide, NUC-7738, which is based on a novel nucleoside analog, 3’-deoxyadenosine, and which has shown potent anti-cancer activity in preclinical studies."

Mr Griffith concluded: "We are very pleased with the progress NuCana made in 2018. We have continued to validate our ProTide technology’s ability to transform some of the most widely prescribed chemotherapy agents into more efficacious and safer treatments. With plans to open a Phase III study of Acelarin plus cisplatin in patients with advanced biliary tract cancer and additional data from the two ongoing studies with NUC-3373, as a single agent in patients with advanced solid tumors as well as in combination with other agents typically combined with 5-FU in patients with advanced colorectal cancer, we anticipate 2019 being another important year for NuCana."

Anticipated Milestones

Acelarin is NuCana’s ProTide transformation of gemcitabine. In 2019, NuCana expects to:

Open a Phase III study of Acelarin combined with cisplatin as a first-line treatment for patients with advanced biliary tract cancer.

Contingent on regulatory guidance and other factors, evaluate the initiation of a Phase II/III study of Acelarin in combination with a platinum agent for patients with ovarian cancer.

Report interim data from the ongoing Phase II study (PRO-105) of single-agent Acelarin for patients with platinum-resistant ovarian cancer.

Continue enrollment in the Phase III study (Acelarate) of Acelarin as a first-line treatment compared to gemcitabine for patients with metastatic pancreatic cancer.

NUC-3373 is NuCana’s second ProTide in clinical development, a transformation of the active anti-cancer metabolite of 5-FU. In 2019, NuCana expects to:

Report interim data from the ongoing Phase Ib study (NuTide:302) of NUC-3373 in patients with advanced colorectal cancer in combination with other agents with which 5-FU is typically combined, including leucovorin, oxaliplatin and irinotecan.

Report additional data from the ongoing Phase I study (NuTide:301) of NUC-3373 in patients with advanced solid tumors.

Contingent on regulatory guidance and other factors, initiate a Phase II/III study of NUC-3373 in combination with other agents for patients with advanced colorectal cancer.

NUC-7738 is NuCana’s ProTide transformation of a novel nucleoside analog, 3’-deoxyadenosine . In 2019, NuCana expects to:

Report interim data from the Phase I study (NuTide:701).

On March 7, 2019 Apellis Pharmaceuticals, Inc., (Nasdaq:APLS) a clinical-stage biopharmaceutical company focused on the development of novel therapeutic compounds to treat disease through the inhibition of the complement system, reported the pricing of its underwritten public offering of 6,000,000 shares of its common stock at a public offering price of $17.00 per share, for total gross proceeds of $102 million, before deducting underwriting discounts and commissions and expenses payable by Apellis (Press release, Apellis Pharmaceuticals, MAR 7, 2019, View Source [SID1234534062]). All of the shares in the offering are being sold by Apellis. In addition, Apellis has granted the underwriters a 30-day option to purchase up to 900,000 additional shares of its common stock at the public offering price, less the underwriting discount and commissions. The offering is expected to close on March 11, 2019, subject to customary closing conditions.

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Citigroup, J.P. Morgan and Cowen are acting as joint book-running managers for the offering. Cantor Fitzgerald & Co. is acting as lead manager for the offering.

The shares are being offered by Apellis pursuant to an effective shelf registration statement that was previously filed with the Securities and Exchange Commission ("SEC") on December 28, 2018 and amended on February 26, 2019. This offering is being made only by means of a prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement relating to and describing the terms of the offering has been filed with the SEC and may be obtained for free by visiting the SEC’s website at www.sec.gov. A final prospectus supplement relating to the offering will be filed with the SEC. When available, copies of the final prospectus supplement and the accompanying prospectus may also be obtained by contacting: Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: 1-800-831-9146; J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: (866) 803-9204; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: (631) 274-2806.

This press release shall not constitute an offer to sell, or a solicitation of an offer to buy these securities, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On March 7, 2019 BioXcel Therapeutics, Inc. ("BTI" or "Company") (Nasdaq: BTAI), reported quarterly results for the fourth quarter and full year ended December 31, 2018 and provided an update on key strategic and operational initiatives (Press release, BioXcel Therapeutics, MAR 7, 2019, View Source [SID1234534061]). BTI is a clinical-stage biopharmaceutical development company utilizing novel artificial intelligence approaches to identify the next wave of medicines across neuroscience and immuno-oncology.

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Fourth Quarter 2018 and Recent Highlights:

(BXCL501)-Neuroscience Program-

·Dosed multiple patient cohorts in the first-in-human pharmacokinetic (bioavailability) and safety study of BXCL501, a novel sublingual thin film formulation of dexmedetomedine (Dex)

·Received FDA Fast Track Designation for BXCL501 for acute treatment of mild to moderate agitation associated with schizophrenia, bipolar disorder, or dementia

·Reported positive proof-of-concept data from two independent Phase 1 studies of intravenously administered Dex with high response rates in Schizophrenia and Alzheimer’s Disease / Dementia, supporting BXCL501 as a potential therapy for acute treatment of agitation in these indications

·Expanded indication for BXCL501 to treat symptoms associated with opioid withdrawal based on positive data from a third Phase 1b study of IV Dex

(BXCL701)-Immuno-Oncology Program-

·Received FDA acceptance of IND for BXCL701, an orally-available systemic innate-immune activator that inhibits dipeptidyl peptidase (DPP) 8/9 and fibroblast activation protein (FAP), for treatment emergent neuroendocrine prostate cancer (tNEPC); patient recruitment ongoing

·Received FDA IND acceptance for clinical trial of BXCL701 in pancreatic cancer to advance understanding of its mechanism of action (MoA); clinical site being activated

·Established clinical partnership with Pfizer and Merck KGaA, Darmstadt, Germany, to evaluate BXCL701 combination therapy in pancreatic cancer, along with Nektar Therapeutics

·Received positive feedback from FDA pre-IND meeting on proposed clinical trial of BXCL701, NKTR-214 and avelumab for treatment of metastatic pancreatic cancer

·Continued to explore additional combination therapy approaches to expand BXCL701’s target indications beyond tNEPC and pancreatic cancer

Emerging Programs-

·Continued to leverage the artificial intelligence platform owned by BioXcel Corporation, BTI’s parent, to select and prioritize additional development opportunities to expand the current portfolio and broaden the addressable market for its lead programs through identification of new indications

Dr. Vimal Mehta, Chief Executive Officer of BTI said, "Following our successful Initial Public Offering we achieved significant clinical, regulatory and operational milestones throughout 2018. Over the last 12 months, we have initiated multiple human clinical trials for BXCL501 and BXCL701, reported positive human proof-of-concept data from several trials, signed new clinical partnerships, significantly advanced Chemistry, Manufacturing and Controls (CMC) work on our lead programs and expanded the addressable markets for these programs. In addition, we are in discussions with a number of highly qualified Board candidates and anticipate appointing a new board member in the near future. As we evolve to a late-clinical-stage organization, we remain confident in the potential of our pipeline assets to generate meaningful clinical benefit for patients in need."

"We dosed multiple patient cohorts in our first-in-human pharmacokinetic (bioavailability) and safety study of BXCL501, and we are on track to report data from this study in the first half of 2019. This data will help establish a foundation to launch registration studies later this year. Additionally, we received FDA Fast Track designation for BXCL501 for the acute treatment of mild to moderate agitation associated with schizophrenia, bipolar disorder, or dementia. This regulatory designation would potentially facilitate the development of BXCL501, allow more frequent meetings and more frequent written communication with the FDA, and expedite its regulatory review.

"In the fourth quarter of 2018, we reported positive data from the Phase 1 studies of Dex for acute treatment of agitation in Schizophrenia and Senile Dementia of the Alzheimer’s Type (SDAT) patients. The positive data from these trials support the continued clinical development of BXCL501 for the acute treatment of agitation in schizophrenia and dementia. We also recently announced positive data from a Phase 1b trial that established the potential application of BXCL501 for the treatment of opioid withdrawal symptoms.

"In our BXCL701 program, we received IND acceptances from the FDA to commence trials in both tNEPC and pancreatic cancer. The Phase 1b trial, which was initiated in late 2018 for tNEPC, will be conducted in combination with pembrolizumab (Keytruda) and will examine safety, pharmacokinetics and anti-tumor activity of the combination therapy. Data from this trial is expected throughout 2019. We also plan to initiate a clinical study to understand the underlying role of BXCL 701 and its mechanism of action in treatment of pancreatic cancer. Pfizer and Merck KGaA recently joined our clinical collaboration with Nektar to advance the triple combination of BXCL701, NKTR-214 and avelumab in this indication. This collaboration reinforces the industry’s enthusiasm around the potential of BXCL701 to treat pancreatic cancer. We believe that our triple combination therapy has the ability to target multiple facets of the disease etiology as well as activate the immune system to produce a clinical benefit in pancreatic cancer patients. We are highly encouraged by this collaboration and look forward to leveraging the regulatory and clinical expertise of our partners as we move forward with our development plans."

Dr. Mehta concluded, "In an effort to further expand the addressable indications for BXCL701, we continue to explore additional combination therapy approaches beyond tNEPC and pancreatic cancer. We are pleased to announce that a recent preclinical study of BXCL701 in combination with an OX40-Agonist was accepted as a late-breaking abstract at the upcoming AACR (Free AACR Whitepaper) Annual Meeting, which we believe demonstrates the broader potential of our lead immuno-oncology candidate beyond tNEPC and pancreatic cancer.

"We are extremely pleased with the substantial progress we have made in advancing both BXCL501 and BXCL701, and believe that our recent achievements have positioned us well for continued growth in 2019 and beyond."

Fourth Quarter & Full Year 2018 Financial Results

BTI reported a net loss of $7.1 million for the fourth quarter of 2018, compared to a net loss of $2.5 million for the same period in 2017.

Research and development expenses were $6.0 million for the fourth quarter of 2018, as compared to $1.4 million for the same period in 2017. The increase was primarily due to an expansion of research and development activities, including increased personnel costs, professional fees, clinical trials, and manufacturing costs associated with BTI’s two lead drug candidates.

General and administrative expenses were $1.3 million for the fourth quarter of 2018, as compared to $1.1 million for the same period in 2017. The increase was primarily due to additional payroll and payroll-related expenses, professional fees and costs associated with operating as a public company.

BTI reported a net loss of $19.3 million for the full year 2018, compared to a net loss of $4.5 million for the same period in 2017.

Research and development expenses were $14.5 million for full year 2018, as compared to $2.7 million for the same period in 2017. The increase was primarily due to an expansion of research and development activities, including increased personnel costs, professional fees, clinical trials, and manufacturing costs associated with BTI’s two lead drug candidates.

General and administrative expenses were $5.4 million for full year 2018, as compared to $1.8 million for the same period in 2017. The increase was primarily due to additional payroll and payroll-related expenses, professional fees and costs associated with operating as a public company.

As of December 31, 2018, cash and cash equivalents totaled $42.6 million.

Upcoming investor conferences:

· 39th Annual Cowen Healthcare Conference — March 11-13, 2019, Boston

· Barclays Global Healthcare Conference — March 12-14, 2019, Miami

· Oppenheimer & Co. 29th Annual Healthcare Conference — March 19-20, 2019, New York City

· H.C. Wainwright Global Life Sciences Conference — April 7-9, 2019, London

· ThinkEquity Conference — May 2, 2019, New York City

· UBS Conference — May 20-22, 2019, New York City

· BMO Capital Markets Prescription for Success Healthcare Conference — May 25, 2019, New York City

About BXCL501:

BXCL501 is a first in class, sublingual film of dexmedetomidine, a selective alpha 2a receptor agonist for the treatment of acute agitation. BTI believes that BXCL501 directly targets a causal agitation mechanism and has demonstrated anti-agitation effects in preclinical and clinical studies. It has a well-established regulatory and reimbursement path in schizophrenia and bipolar disorder, as demonstrated by a previously-approved drug, Adasuve.

About BXCL701:

BXCL701 is a first in class oral immunotherapy with dual mechanisms of action, with an established safety profile from 700 healthy subjects and cancer patients. Designed to stimulate both the innate and acquired immune systems, BXCL701 works by inhibiting dipeptidyl peptidase (DPP) 8/9 and blocking immune evasion by targeting fibroblast activation protein (FAP). Preclinical combination data evaluating BXCL701, a checkpoint inhibitor and other IO agents has demonstrated encouraging anti-tumor activity in multiple tumor types and formation of functional immunological memory. It is under development for tNEPC and pancreatic cancer.

On March 7, 2019 Cleveland BioLabs, Inc. (NASDAQ:CBLI) reported financial results and development progress for the fourth quarter and year ended December 31, 2018 (Press release, Cleveland BioLabs, MAR 7, 2019, View Source [SID1234534060]).

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Cleveland BioLabs reported a net loss of $(0.4) million, excluding minority interests, for the fourth quarter of 2018, or $(0.04) per share, compared to a net loss, excluding minority interests, of $(1.2) million, or $(0.10) per share, for the same period in 2017. Net loss, excluding minority interests, for full year 2018 was $(3.6) million, or $(0.32) per share, compared to a net loss of $(9.7) million, or $(0.87) per share, for full year 2017. The decrease in net loss for 2018 was primarily due to a decrease in the non-cash adjustment to our warrant liabilities, reduced operating costs in performance of the Joint Warfighter Medical Research Program contract for the Department of Defense as we awaited the completion of the bioequivalence study comparing the historical drug formulation used in prior preclinical and clinical studies with the to-be-marketed drug product lots, which results were delayed in 2018, and a reduction in EMEA activities, as a result of the withdrawal of our application before the European Medicines Agency, partially offset by increased expenses related to oncology applications of the entolimod family of compounds and an increase in General and Administrative costs related to the corporate formation of Genome Protection, Inc. (GPI), our joint venture with Everon Biosciences, Inc. focused on developing anti-aging medications.

As of December 31, 2018, the Company had $4.1 million in cash, cash equivalents and short-term investments, which, based on the Company’s current operational plan, is expected to fund operations into December of 2019.

Yakov Kogan, Ph.D., MBA, Chief Executive Officer, stated, "The development, pursuit of regulatory approval and commercialization for entolimod as a medical radiation countermeasure remains our top priority."

"We recently completed an in vivo bio-comparability study in non-human primates (NHP) between the drug formulation used in previously conducted preclinical and clinical studies and the entolimod drug formulation proposed for commercialization under the pre-Emergency Use Authorization or pre-EUA application with the US Food and Drug Administration," added Dr. Kogan. "While the NHP study was ongoing, the FDA proceeded with further review of the entolimod chemistry, manufacturing, and controls (CMC) information in our pre-EUA dossier and recently the FDA provided us with comments and questions on various aspects of entolimod CMC. Per FDA recommendation, the Company has now requested a meeting to brief the FDA on the results of the NHP bio-comparability data and is preparing responses to the FDA comments on entolimod CMC. We expect that after review and discussion of the bio-comparability data and the CMC information, the FDA will proceed with review of additional components of the pre-EUA dossier."

Further Financial Results

Revenue for the fourth quarter of 2018 decreased to $0.2 million compared to $0.9 million for the fourth quarter of 2017. Revenue for full year 2018 was $1.1 million compared to $1.9 million for full year 2017. The net decrease was primarily attributable to decreased revenue from our Joint Warfighter Medical Research Program contract from the Department of Defense for the continued development of the entolimod as a medical radiation countermeasure.

Research and development costs for the fourth quarter of 2018 decreased to $0.5 million compared to $1.5 million for the fourth quarter of 2017. Research and development costs for the full year 2018 decreased to $3.6 million compared to $5.0 million for the full year 2017. The reduction in research and development costs is due to a $1.9 million reduction in spending for biodefense applications of entolimod, partially offset by a $0.6 million increase in spending related to the oncology applications of the entolimod family of compounds.

General and administrative costs for the fourth quarter of 2018 decreased to $0.3 million compared to $0.6 million for the fourth quarter of 2017. General and administrative costs for the full year 2018 decreased to $2.3 million compared to $2.5 million for full year 2017. This decrease was primarily attributable to reductions in personnel and outside professional costs as well as a reduction in other operating expenses due to a decrease in property tax expense.

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.