On April 2, 2018 Synlogic (Nasdaq:SYBX), a clinical-stage company applying synthetic biology to probiotic bacteria to develop novel living medicines, reported that the first patient was dosed in its Phase 1b/2a clinical trial of SYNB1020 (Press release, Synlogic, APR 2, 2018, View Source [SID1234525474]). SYNB1020 is a Synthetic Biotic medicine being developed for the treatment of hyperammonemia, associated with cirrhosis and urea cycle disorders (UCDs), which can result in severe and life-threatening consequences for patients. This randomized, double-blind, placebo-controlled study is designed to evaluate the safety and tolerability of SYNB1020, as well as its ability to lower blood-ammonia levels in patients with cirrhosis and elevated blood ammonia.

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"Our recently reported Phase 1 trial of SYNB1020 demonstrated that this Synthetic Biotic medicine was well tolerated and provided a dose-dependent proof of mechanism, functioning as designed in healthy volunteers. We look forward to evaluating the safety, tolerability and therapeutic potential of SYNB1020 in patients with liver disease who have developed cirrhosis," said Aoife Brennan, M.B., B.Ch., Synlogic’s chief medical officer. "There is unmet medical need for additional treatment options for patients with chronic liver disease and we are excited by the potential of SYNB1020 in this indication."

Synthetic Biotic therapies are designed to function in the gastrointestinal tract to convert metabolites that can build up to toxic levels in the blood into harmless metabolites that can be excreted from the body. Elevated blood ammonia levels are toxic to the brain and can have severe consequences, including neurologic crises requiring hospitalization and resulting in irreversible cognitive damage and death. SYNB1020 is designed to consume ammonia and convert it to arginine, an amino acid.

About Synlogic’s Phase 1b/2a Trial of SYNB1020 in Patients with Cirrhosis

This Phase 1b/2a study has two parts:

First, an initial sentinel open-label cohort of subjects with cirrhosis and a Model for End-Stage Liver Disease (MELD) score < 12 will receive orally administered SYNB1020 (5 x 1011 CFU TID) for six days. Subjects will be admitted to an inpatient facility for a run-in diet, baseline assessments, safety monitoring, and collection of blood, urine, and fecal samples for the evaluation of safety, tolerability, pharmacokinetics and pharmacodynamics of treatment. Once safety and tolerability have been established in these subjects, enrollment will be opened to subjects in Part 2.

Part 2 of the trial comprises a randomized, double-blinded, placebo-controlled study in patients with cirrhosis and hyperammonemia. Eligible subjects will be admitted to an inpatient facility for a run-in diet and 24-hour ammonia profile, and those with an elevated ammonia level will proceed with randomization and receive either placebo or orally administered SYNB1020 (5 x 1011 CFU TID) for six days. The primary endpoint of the study is safety and tolerability. In addition, the study will evaluate the effect of SYNB1020 administration on plasma ammonia levels as well as other exploratory endpoints.

Synlogic expects to report top-line data from this trial by year-end 2018. More information on this study can be found at View Source under the study ID NCT03447730.

About Hyperammonemia

Hyperammonemia is a metabolic condition characterized by an excess of ammonia in the blood. In healthy individuals, ammonia is primarily produced in the intestine as a byproduct of protein metabolism and microbial degradation of nitrogen-containing compounds. Ammonia is then converted to urea in the liver and is excreted in urine. However, if the liver’s ability to convert ammonia to urea is compromised, either due to a genetic defect such as UCDs or acquired liver disease that leads to cirrhosis, ammonia accumulates in the blood. Elevated blood ammonia levels are toxic to the brain and can have severe consequences, including neurologic crises requiring hospitalization, irreversible cognitive damage and death.

About Synthetic Biotic Medicines

Synlogic’s innovative new class of Synthetic Biotic medicines leverages the tools and principles of synthetic biology to genetically engineer probiotic microbes to perform or deliver critical functions missing or damaged due to disease. The company’s two lead programs, SYNB1020 and SYNB1618, target hyperammonemia as a result of liver damage or genetic disease, and phenylketonuria, respectively. Patients with these diseases are unable to break down commonly occurring by-products of digestion that then accumulate to toxic levels and cause serious health consequences. When delivered orally, Synthetic Biotic medicines can act from the gut to compensate for the dysfunctional metabolic pathway and have a systemic effect, with the potential to significantly improve symptoms of disease for affected patients. Synlogic has earlier-stage programs that apply the broad potential of its Synthetic Biotic platform in other disease areas, from inflammatory and immune disorders to cancer.

On April 2, 2018 Allergan plc (NYSE: AGN) reported it intends to release first quarter 2018 financial results on Monday, April 30, 2018, prior to the open of U.S. financial markets (Press release, Allergan, APR 2, 2018, View Source [SID1234525110]).

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Allergan will host a conference call and webcast at 8:30 a.m. Eastern Time on Monday, April 30, 2018 to discuss its financial results. The dial-in number to access the call is U.S./Canada (877) 251-7980, International (706) 643-1573, and the conference ID is 67781149.

A taped replay of the conference call will also be available beginning approximately two hours after the call’s conclusion, and will remain available through 11:30 p.m. Eastern Time on May 30, 2018. The replay may be accessed by dialing (855) 859-2056 or (404) 537-3406, and entering the conference ID 67781149.

To access the webcast, please visit Allergan’s Investor Relations website at View Source;. A replay of the webcast will also be available on Allergan’s Investor Relations website.

On April 2, 2018 Argos Therapeutics, Inc. (Nasdaq:ARGS), an immuno-oncology company focused on the development and commercialization of individualized immunotherapies based on the Arcelis precision immunotherapy technology platform, reported financial results and operational highlights for the fourth quarter and full year 2017 (Press release, Argos Therapeutics, APR 2, 2018, View Source [SID1234525111]).

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Jeff Abbey, CEO of Argos Therapeutics, stated, "Although we faced a very challenging 2017, we have been able to continue the Phase 3 ADAPT clinical trial of Rocapuldencel-T for the treatment of metastatic renal cell carcinoma, and look forward to the next interim data analysis, which we expect to occur during the second quarter of 2018. In addition to continuing the ADAPT study, we look forward to initial results from the ongoing study of AGS-004 in combination with the latency-reversing agent vorinostat in adult HIV patients being conducted by the University of North Carolina, which we expect will be reported towards the end of 2018 or early 2019. We were also pleased to have recently secured an option to a PD1 checkpoint inhibitor, and, subject to obtaining additional funding, plan to conduct a clinical trial of Rocapuldencel-T in combination either with this agent or with an approved checkpoint inhibitor. Also of note, we have strengthened our financial position by raising net proceeds of approximately $23 million since June 2017 through our at-the-market facility, and believe that we now have sufficient capital to fund planned operations through the end of this year."

ADAPT Study Update

The Company is currently finalizing an amendment to the protocol for the ADAPT trial, which includes an amended primary endpoint analysis, and plans to submit it to the FDA prior to the interim data analysis planned for the second quarter of 2018. The Company expects that the interim data analysis will occur after such time as approximately 55 new events (deaths) have occurred subsequent to the February 2017 interim analysis. The amended primary endpoint analysis in the planned amended ADAPT protocol includes the following four co-primary endpoints:

Overall survival for all randomized patients when approximately 375 events have occurred (under the same analysis that was originally planned for 290 events);
The percentage of patients surviving at least five years;
Overall survival for patients who remained alive at the time of the February 2017 interim analysis, to be evaluated when approximately 155 new events have occurred; and
Overall survival for all patients for whom at least 12 months of follow-up is available (excluding patients who died or were lost to follow-up within the first 12 months after enrollment).
Operational and Corporate Highlights

Since the end of the third quarter of 2017, the Company has reported the following events:

In November 2017, the Company announced the receipt of a $1.5 million milestone payment from Lummy (Hong Kong) Co., Ltd. ("Lummy"), the Company’s licensee for Rocapuldencel-T in China and certain other territories, related to the successful transfer of technology related to the manufacturing of Rocapuldencel-T.
In November 2017, the Company reported updated immunology data from the Phase 3 ADAPT study at the 32nd Annual Meeting of the Society for the Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) that were generally supportive of the hypothesis regarding the intended mechanism of action of Rocapuldencel-T to induce an immune response against the tumor in patients with metastatic renal cell carcinoma.
In November 2017, the Company announced that it had reached agreement with Saint-Gobain Corporation ("Saint-Gobain"), one of the Company’s vendors, regarding the payment of deferred fees. The Company agreed to settle its obligations to Saint-Gobain through a combination of a $0.5 million cash payment, delivery of 34,500 shares of common stock (as adjusted for the one-for-twenty reverse stock split), issuance of an approximately $2.4 million unsecured convertible promissory note and return of certain specified equipment previously provided to the Company.
In November 2017, the Company reported that the landlord of the facility in Durham County, NC that Argos had previously intended to utilize as its primary manufacturing facility ("Centerpoint"), had, with Argos’ full consent, successfully completed the sale of this facility to a third party. In connection with this transaction, Argos entered into a lease termination agreement pursuant to which Argos received cash proceeds of approximately $1.8 million.
In January 2018 the Company entered into a stock purchase agreement with Lummy under which the Company agreed to issue and sell to Lummy in a private financing 375,000 shares of common stock (as adjusted for the one-for-twenty reverse stock split) for an aggregate purchase price of $1.5 million. In March 2018, the stock purchase agreement was amended to reduce the aggregate purchase price for the shares to $450,000. Concurrent with such amendment, the license agreement with Lummy was amended to provide for a $1.05 million milestone payment, which the Company has earned. Payments with respect to these amended agreements are expected to be received during April 2018.
In January 2018, the Company implemented a one-for-twenty reverse stock split, and subsequently regained compliance with the Nasdaq $1.00 minimum bid price requirement. The Company was also granted an extension until April 24, 2018 to regain compliance with the $2.5 million minimum shareholders’ equity requirement for continued listing on the Nasdaq Capital Market.
From June 2017 through December 31, 2017, the Company raised net proceeds of $15.5 million through the issuance of common stock in an at-the-market offering under the Company’s original sales agreement with Cowen & Company, LLC ("Cowen"). In February 2018, the original sales agreement with Cowen was amended to increase the maximum aggregate offering price of the shares of the Company’s common stock which may be sold under the agreement from $30 million to $45 million. As of March 16, 2018, an additional $7.3 million of net proceeds had been raised through the sale of the Company’s common stock subsequent to December 31, 2017 and $15.8 million remained available for sale.
In February 2018, the Company announced that it had entered into an option agreement with Pharmstandard International, S.A., the Company’s partner in Russia and certain other territories, and Actigen Limited under which the Company has an option to license a group of fully human anti-PD1 monoclonal antibodies (PD1 checkpoint inhibitors) and related technology.
In February 2018, the Company announced the issuance of a patent covering the strain-independent amplification of human immunodeficiency virus, or HIV, nucleic acid sequences for use in vaccinations. The methods described in this patent form the foundation for the manufacture of AGS-004, Argos’ experimental dendritic cell-based immunotherapy for HIV.
Financial Results

Fourth Quarter 2017 Financials

Revenue for the fourth quarter ended December 31, 2017 was $1.7 million compared to $0.2 million during the fourth quarter of 2016. The increase in revenue during the fourth quarter of 2017 compared with the fourth quarter of 2016 resulted from the receipt of a $1.5 million milestone payment from Lummy related to the transfer of technology for the manufacture of Rocapuldencel-T.

Research and development expense for the fourth quarter ended December 31, 2017 was $4.1 million compared to $10.3 million during the fourth quarter of 2016. The decrease in research and development expense during the fourth quarter of 2017 compared with the fourth quarter of 2016 was due to reduced expenses associated with the Phase 3 ADAPT trial and the Company’s decision not to proceed with the development of commercial manufacturing capabilities as well as to significantly reduce the size of its workforce engaged in research and development activities following the independent data monitoring committee’s ("IDMC") recommendation in February 2017 to discontinue the ADAPT trial for futility.

General and administrative expense for the fourth quarter ended December 31, 2017 was $2.7 million compared to $4.8 million during the fourth quarter of 2016. The decrease in general and administrative expense during the fourth quarter of 2017 compared with the fourth quarter of 2016 was primarily due to decreased consulting and personnel costs.

Additionally, during the fourth quarter of 2017 the Company recognized a gain on disposal of impaired property of $2.8 million resulting from proceeds of $1.8 million that were received in connection with the sale of the Centerpoint facility and a $1.0 million gain from the disposal of certain property from the Saint-Gobain debt restructuring, as well as a $0.6 million gain on the early extinguishment of debt related to the Saint-Gobain debt restructuring. During the fourth quarter ended December 31, 2016, the Company recorded an impairment charge of $0.7 million, which was partially offset by a non-cash gain due to the decrease in the value of the warrant liability of $0.6 million.

Interest expense for the fourth quarter ended December 31, 2017 was $0.2 million compared to $0.3 million during the fourth quarter of 2016. The decrease in interest expense during the fourth quarter of 2017 compared with the fourth quarter of 2016 was primarily due to a lower average balance of debt outstanding.

Reflecting the factors noted above, net loss for the fourth quarter ended December 31, 2017 was $1.9 million compared to a net loss of $15.4 million during the fourth quarter of 2016.

Full Year 2017 Financials

Revenue for the year ended December 31, 2017 was $1.9 million compared to $0.9 million during 2016. The increase in revenue for 2017 compared with 2016 resulted primarily from the receipt of a $1.5 million milestone payment from Lummy during 2017, which was partially offset by the $0.6 million decrease in reimbursement under the Company’s contract with the National Institutes of Health and the National Institute of Allergy and Infectious Diseases primarily reflecting the achievement of certain specified development milestones under the Company’s AGS-004 program during 2016.

Research and development expense for the year ended December 31, 2017 was $21.7 million compared to $38.3 million during 2016. The decrease in research and development expense for 2017 compared with 2016 was due to reduced expenses associated with the Phase 3 ADAPT trial and the Company’s decision not to proceed with the development of commercial manufacturing capabilities and to significantly reduce the size of its workforce engaged in research and development activities following the recommendation of the IDMC in February 2017 to discontinue the ADAPT trial for futility.

General and administrative expense for the year ended December 31, 2017 was $12.2 million compared to $14.2 million during 2016. The decrease in general and administrative expense for 2017 compared with 2016 was primarily due to decreased consulting and personnel costs.

Additionally, during the year ended December 31, 2017 the Company incurred impairment charges of $27.3 million and restructuring charges of $6.0 million related to the Company’s decision to discontinue preparation for commercial manufacturing and reduce the size of its workforce, which amounts were partially offset by a non-cash gain due to the decrease in the value of the warrant liability of $20.8 million, a gain on the disposal of impaired property of $2.8 million, and a gain on the early extinguishment of debt of $2.4 million. During the year ended December 31, 2016, the Company recorded a non-cash gain due to the decrease in the value of the warrant liability of $1.0 million, which was partially offset by an impairment charge of $0.7 million.

Interest expense for the year ended December 31, 2017 was $1.3 million compared to $1.8 million during 2016. The decrease in interest expense for 2017 compared with 2016 was primarily due to a lower average balance of debt outstanding, partially offset by the decision to no longer capitalize the interest related to construction of the Centerpoint facility following the decision not to proceed with plans to develop this facility.

Reflecting the factors noted above, net loss for the year ended December 31, 2017 was $40.6 million compared to a net loss of $53.0 million during 2016.

As of December 31, 2017, cash and cash equivalents totaled $15.2 million. The Company expects that its current cash and cash equivalents, including approximately $7.3 million in net proceeds that the Company has raised from the sale of its common stock in its at-the-market facility during the first quarter of 2018, will be sufficient to fund its planned operations through the end of 2018.Argos Therapeutics, Inc. (Nasdaq:ARGS), an immuno-oncology company focused on the development and commercialization of individualized immunotherapies based on the Arcelis precision immunotherapy technology platform, today reported financial results and operational highlights for the fourth quarter and full year 2017.

Jeff Abbey, CEO of Argos Therapeutics, stated, "Although we faced a very challenging 2017, we have been able to continue the Phase 3 ADAPT clinical trial of Rocapuldencel-T for the treatment of metastatic renal cell carcinoma, and look forward to the next interim data analysis, which we expect to occur during the second quarter of 2018. In addition to continuing the ADAPT study, we look forward to initial results from the ongoing study of AGS-004 in combination with the latency-reversing agent vorinostat in adult HIV patients being conducted by the University of North Carolina, which we expect will be reported towards the end of 2018 or early 2019. We were also pleased to have recently secured an option to a PD1 checkpoint inhibitor, and, subject to obtaining additional funding, plan to conduct a clinical trial of Rocapuldencel-T in combination either with this agent or with an approved checkpoint inhibitor. Also of note, we have strengthened our financial position by raising net proceeds of approximately $23 million since June 2017 through our at-the-market facility, and believe that we now have sufficient capital to fund planned operations through the end of this year."

ADAPT Study Update

The Company is currently finalizing an amendment to the protocol for the ADAPT trial, which includes an amended primary endpoint analysis, and plans to submit it to the FDA prior to the interim data analysis planned for the second quarter of 2018. The Company expects that the interim data analysis will occur after such time as approximately 55 new events (deaths) have occurred subsequent to the February 2017 interim analysis. The amended primary endpoint analysis in the planned amended ADAPT protocol includes the following four co-primary endpoints:

Overall survival for all randomized patients when approximately 375 events have occurred (under the same analysis that was originally planned for 290 events);
The percentage of patients surviving at least five years;
Overall survival for patients who remained alive at the time of the February 2017 interim analysis, to be evaluated when approximately 155 new events have occurred; and
Overall survival for all patients for whom at least 12 months of follow-up is available (excluding patients who died or were lost to follow-up within the first 12 months after enrollment).
Operational and Corporate Highlights

Since the end of the third quarter of 2017, the Company has reported the following events:

In November 2017, the Company announced the receipt of a $1.5 million milestone payment from Lummy (Hong Kong) Co., Ltd. ("Lummy"), the Company’s licensee for Rocapuldencel-T in China and certain other territories, related to the successful transfer of technology related to the manufacturing of Rocapuldencel-T.
In November 2017, the Company reported updated immunology data from the Phase 3 ADAPT study at the 32nd Annual Meeting of the Society for the Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) that were generally supportive of the hypothesis regarding the intended mechanism of action of Rocapuldencel-T to induce an immune response against the tumor in patients with metastatic renal cell carcinoma.
In November 2017, the Company announced that it had reached agreement with Saint-Gobain Corporation ("Saint-Gobain"), one of the Company’s vendors, regarding the payment of deferred fees. The Company agreed to settle its obligations to Saint-Gobain through a combination of a $0.5 million cash payment, delivery of 34,500 shares of common stock (as adjusted for the one-for-twenty reverse stock split), issuance of an approximately $2.4 million unsecured convertible promissory note and return of certain specified equipment previously provided to the Company.
In November 2017, the Company reported that the landlord of the facility in Durham County, NC that Argos had previously intended to utilize as its primary manufacturing facility ("Centerpoint"), had, with Argos’ full consent, successfully completed the sale of this facility to a third party. In connection with this transaction, Argos entered into a lease termination agreement pursuant to which Argos received cash proceeds of approximately $1.8 million.
In January 2018 the Company entered into a stock purchase agreement with Lummy under which the Company agreed to issue and sell to Lummy in a private financing 375,000 shares of common stock (as adjusted for the one-for-twenty reverse stock split) for an aggregate purchase price of $1.5 million. In March 2018, the stock purchase agreement was amended to reduce the aggregate purchase price for the shares to $450,000. Concurrent with such amendment, the license agreement with Lummy was amended to provide for a $1.05 million milestone payment, which the Company has earned. Payments with respect to these amended agreements are expected to be received during April 2018.
In January 2018, the Company implemented a one-for-twenty reverse stock split, and subsequently regained compliance with the Nasdaq $1.00 minimum bid price requirement. The Company was also granted an extension until April 24, 2018 to regain compliance with the $2.5 million minimum shareholders’ equity requirement for continued listing on the Nasdaq Capital Market.
From June 2017 through December 31, 2017, the Company raised net proceeds of $15.5 million through the issuance of common stock in an at-the-market offering under the Company’s original sales agreement with Cowen & Company, LLC ("Cowen"). In February 2018, the original sales agreement with Cowen was amended to increase the maximum aggregate offering price of the shares of the Company’s common stock which may be sold under the agreement from $30 million to $45 million. As of March 16, 2018, an additional $7.3 million of net proceeds had been raised through the sale of the Company’s common stock subsequent to December 31, 2017 and $15.8 million remained available for sale.
In February 2018, the Company announced that it had entered into an option agreement with Pharmstandard International, S.A., the Company’s partner in Russia and certain other territories, and Actigen Limited under which the Company has an option to license a group of fully human anti-PD1 monoclonal antibodies (PD1 checkpoint inhibitors) and related technology.
In February 2018, the Company announced the issuance of a patent covering the strain-independent amplification of human immunodeficiency virus, or HIV, nucleic acid sequences for use in vaccinations. The methods described in this patent form the foundation for the manufacture of AGS-004, Argos’ experimental dendritic cell-based immunotherapy for HIV.
Financial Results

Fourth Quarter 2017 Financials

Revenue for the fourth quarter ended December 31, 2017 was $1.7 million compared to $0.2 million during the fourth quarter of 2016. The increase in revenue during the fourth quarter of 2017 compared with the fourth quarter of 2016 resulted from the receipt of a $1.5 million milestone payment from Lummy related to the transfer of technology for the manufacture of Rocapuldencel-T.

Research and development expense for the fourth quarter ended December 31, 2017 was $4.1 million compared to $10.3 million during the fourth quarter of 2016. The decrease in research and development expense during the fourth quarter of 2017 compared with the fourth quarter of 2016 was due to reduced expenses associated with the Phase 3 ADAPT trial and the Company’s decision not to proceed with the development of commercial manufacturing capabilities as well as to significantly reduce the size of its workforce engaged in research and development activities following the independent data monitoring committee’s ("IDMC") recommendation in February 2017 to discontinue the ADAPT trial for futility.

General and administrative expense for the fourth quarter ended December 31, 2017 was $2.7 million compared to $4.8 million during the fourth quarter of 2016. The decrease in general and administrative expense during the fourth quarter of 2017 compared with the fourth quarter of 2016 was primarily due to decreased consulting and personnel costs.

Additionally, during the fourth quarter of 2017 the Company recognized a gain on disposal of impaired property of $2.8 million resulting from proceeds of $1.8 million that were received in connection with the sale of the Centerpoint facility and a $1.0 million gain from the disposal of certain property from the Saint-Gobain debt restructuring, as well as a $0.6 million gain on the early extinguishment of debt related to the Saint-Gobain debt restructuring. During the fourth quarter ended December 31, 2016, the Company recorded an impairment charge of $0.7 million, which was partially offset by a non-cash gain due to the decrease in the value of the warrant liability of $0.6 million.

Interest expense for the fourth quarter ended December 31, 2017 was $0.2 million compared to $0.3 million during the fourth quarter of 2016. The decrease in interest expense during the fourth quarter of 2017 compared with the fourth quarter of 2016 was primarily due to a lower average balance of debt outstanding.

Reflecting the factors noted above, net loss for the fourth quarter ended December 31, 2017 was $1.9 million compared to a net loss of $15.4 million during the fourth quarter of 2016.

Full Year 2017 Financials

Revenue for the year ended December 31, 2017 was $1.9 million compared to $0.9 million during 2016. The increase in revenue for 2017 compared with 2016 resulted primarily from the receipt of a $1.5 million milestone payment from Lummy during 2017, which was partially offset by the $0.6 million decrease in reimbursement under the Company’s contract with the National Institutes of Health and the National Institute of Allergy and Infectious Diseases primarily reflecting the achievement of certain specified development milestones under the Company’s AGS-004 program during 2016.

Research and development expense for the year ended December 31, 2017 was $21.7 million compared to $38.3 million during 2016. The decrease in research and development expense for 2017 compared with 2016 was due to reduced expenses associated with the Phase 3 ADAPT trial and the Company’s decision not to proceed with the development of commercial manufacturing capabilities and to significantly reduce the size of its workforce engaged in research and development activities following the recommendation of the IDMC in February 2017 to discontinue the ADAPT trial for futility.

General and administrative expense for the year ended December 31, 2017 was $12.2 million compared to $14.2 million during 2016. The decrease in general and administrative expense for 2017 compared with 2016 was primarily due to decreased consulting and personnel costs.

Additionally, during the year ended December 31, 2017 the Company incurred impairment charges of $27.3 million and restructuring charges of $6.0 million related to the Company’s decision to discontinue preparation for commercial manufacturing and reduce the size of its workforce, which amounts were partially offset by a non-cash gain due to the decrease in the value of the warrant liability of $20.8 million, a gain on the disposal of impaired property of $2.8 million, and a gain on the early extinguishment of debt of $2.4 million. During the year ended December 31, 2016, the Company recorded a non-cash gain due to the decrease in the value of the warrant liability of $1.0 million, which was partially offset by an impairment charge of $0.7 million.

Interest expense for the year ended December 31, 2017 was $1.3 million compared to $1.8 million during 2016. The decrease in interest expense for 2017 compared with 2016 was primarily due to a lower average balance of debt outstanding, partially offset by the decision to no longer capitalize the interest related to construction of the Centerpoint facility following the decision not to proceed with plans to develop this facility.

Reflecting the factors noted above, net loss for the year ended December 31, 2017 was $40.6 million compared to a net loss of $53.0 million during 2016.

As of December 31, 2017, cash and cash equivalents totaled $15.2 million. The Company expects that its current cash and cash equivalents, including approximately $7.3 million in net proceeds that the Company has raised from the sale of its common stock in its at-the-market facility during the first quarter of 2018, will be sufficient to fund its planned operations through the end of 2018.

On April 2, 2018 Bristol-Myers Squibb Company (NYSE: BMY) reported it will hold an investor event on Monday, April 16, 2018 at 6:00 p.m. EDT (5:00 p.m. CDT) to discuss data presented at the Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) in Chicago (Press release, Bristol-Myers Squibb, APR 2, 2018, View Source [SID1234525112]). Company executives will provide an overview of data presented from the company’s oncology portfolio, and address questions from investors and analysts.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Investors and the general public are invited to listen to a live webcast of the event at investor.bms.com. Materials related to the event will be available at the same website prior to the event. A replay of the event will be available and can be accessed at investor.bms.com.

On April 2, 2018 Cancer Genetics, Inc. (Nasdaq:CGIX), a leader in enabling precision medicine for oncology through molecular markers and diagnostics, reported financial and operating results for the fourth quarter and full year ended December 31, 2017 as well as an update on its strategic direction and key organizational initiatives (Press release, Cancer Genetics, APR 2, 2018, View Source [SID1234525113]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Following the departure of its former CEO, the Company has undertaken a comprehensive and extensive review of its strategy and organization. This included operations, pipeline programs, revenue streams, and financial resources. Its goal has been to focus the business through targeted investment in the Company’s core strengths, to continue to streamline operations, and to reduce costs.

In the first quarter of 2018, the Company has been focused on developing and implementing a transformative strategy to increase revenues, improve cash collections and reduce costs, allowing the Company to execute on its broader growth plan. Management intends to focus on growing both the Biopharma and Discovery businesses in the US and globally. Combined, Biopharma and Discovery services represented 63% of the Company’s total revenue in 2017, and the Company expects to increase this portion of its business in these two markets through 2018. Demand for the Company’s services in both of these markets continues to show strength, as the Company exited Q4 2017 supporting over 220 clinical trials and studies focused on solid tumor and blood-borne cancers, and 74 preclinical efficacy and toxicology studies, including 59 and 36 respectively for immuno-oncology indications.

A major area of concentrated focus during the first quarter of 2018 was the careful evaluation of the Company’s accounts receivables, which had increased to approximately $16 million on the balance sheet prior to any adjustments. A significant reason for the increase was disruptions in collections in its Clinical Services business. While the Company continues with its collections efforts on all claims, in the fourth quarter it recorded a bad debt expense of $4.4 million and wrote off $1.8 million of its accounts receivable, with a significant portion of the bad debt expense and write off related to collection issues with respect to the accounts receivable recorded subsequent to the 2015 acquisition of Response Genetics Inc. Payors have declined to reimburse the Company on certain performed Clinical services due to delays in filing its claims, the demands by payors for copies of patient medical records or diagnosis codes which have been difficult to obtain, and reimbursement challenges for certain of our next generation sequencing tests by Medicare and third-party managed care plans, among other reasons. As such, the Company has made a prudent decision to write these off in the fourth quarter. Management believes that its current outstanding accounts receivables are collectible, net of the allowance for doubtful accounts.

The Company expects to file its Annual Report on Form 10-K for the year ended December 31, 2017 today with the Securities and Exchange Commission. The audited financial statements contain a going concern qualification paragraph in the audit opinion from its independent registered public accounting firm. The Company will also disclose that it had a Material Weakness in Internal Controls Over Financial Reporting at December 31, 2017. See further discussion in Note 2 to the Company’s consolidated financial statements included in the Company’s Annual Report on Form 10-K.

The Company also announced that it has engaged Raymond James & Associates, Inc. as a financial advisor to assist with evaluating options for the Company’s strategic direction. These options may include raising additional capital, the acquisition of another company and / or complementary assets, the sale of the Company, or another type of strategic partnership.

The Company’s Board of Directors is committed to evaluating all potential strategic opportunities and to pursuing the path most likely to create both near- and longer-term value for Cancer Genetics’ shareholders.

John A. (Jay) Roberts, interim Chief Executive Officer and COO of Cancer Genetics said, "We are intently focused on enhancing our financial and competitive position through efforts to expand our Biopharma and Discovery businesses through pursuit of select new partnerships and large volume contracts in precision oncology. Our leading and unique capabilities and comprehensive portfolio in precision oncology allow us to provide pharmaceutical and biotechnology partners with unparalleled clinical trial strategy and support services, including genomics testing, biomarker measurement and identification, custom protocol execution and patient monitoring. We believe we have the strongest, most comprehensive test portfolio in the industry, based on a broad selection of methodologies, including Complete::IO, Tissue of Origin TOO, the Oncomine Dx Target Test from Thermo Fisher, Liquid::Lung-cfDNA and others. We are committed to optimizing and leveraging this robust suite of unique oncology diagnostics to drive growth across multiple areas of our business, are confident in our new growth strategy and in our team’s ability to implement it, and believe that the execution of this strategy has the potential to drive shareholder value."

FOURTH QUARTER 2017 AND RECENT OPERATIONAL HIGHLIGHTS

Raised $7 million through the sale of 3.5 million units consisting of one share and one warrant, through a registered direct offering to support the Company’s operational and business expenses.
Received approval from the New York State Department of Health for Thermo Fisher Scientific’s Oncomine Dx Target Test, the first FDA-approved companion diagnostic test for lung cancer.
Expanded its immuno-oncology (IO) panel, Complete::IO, to include five new IO markers bringing the total number of simultaneously detectable markers to twenty seven. Complete::IO is the most comprehensive flow-cytometry-based biomarker panel with a 24-hour turnaround time.
Delivered an oral presentation at the 2017 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting demonstrating the potential value of an agnostic platform along with best diagnostic modality to evaluate PD-L1 in DLBCL (Diffuse Large B-Cell Lymphomas).
Appointed renowned biotech entrepreneur Thomas F. Widmann, MD to the Company’s Board of Directors to advise the company on improving business growth and advancing its test and services portfolio.
Presented two oral presentations at the Association for Molecular Pathology Annual 2017 meeting highlighting the role of next-generation sequencing in lung cancer biomarker testing, comprising of the Company’s liquid biopsy test, Liquid::Lung-cfDNA.
FOURTH QUARTER 2017 FINANCIAL RESULTS

The Company reported total revenue of $7.5 million for the fourth quarter of 2017 compared to revenue of $7.2 million in fourth quarter of 2016, an increase of 4% or $0.3 million.

Biopharma services revenue totaled $3.5 million in the fourth quarter, compared to $4 million during the fourth quarter 2016. Biopharma projects are dependent on the timing, size and duration of our contracts with pharmaceutical and biotech companies and clinical research organizations, and can fluctuate in comparable periods. The Company increased the number of clinical studies and trials it is supporting to 224, up from 125 in Q4 2016.

​Clinical Services revenue decreased by approximately $1.1 million in the fourth quarter of 2017 compared to the same period in 2016, from $3 million to $1.9 million. The decrease in revenue was primarily related to higher contractual allowance adjustments than the Company historically has taken following its examination of outstanding receivables. The Company’s Discovery Services contributed $2.1 million in revenue for the fourth quarter of 2017, an increase of approximately $1.8 million compared to the fourth quarter of 2016, driven by the first full quarter of vivoPharm revenue following its August 2017 acquisition and growing demand for early stage discovery results combined with bioinformatics analysis capabilities.

Gross profit margin decreased to 30.0% or $2.3 million in Q4 2017, compared to 41% or $2.9 million in the fourth quarter 2016. The gross margin percentage was impacted by lower revenue in the fourth quarter of 2017 in Biopharma and the contractual allowance adjustment made to Clinical Services, partially offset by the increase in revenue from Discovery Services.

Total operating expenses for the fourth quarter of 2017 were approximately $11.8 million, an increase of 82% compared to $6.5 million during the fourth quarter of 2016. The increase in total operating expenses is primarily the result of the Company recording an additional $4.4 million in bad debt expense, to increase its reserve for doubtful accounts receivable.

Net loss was $7.9 million or $0.35 per share for the fourth quarter of 2017, compared to a net loss of $2.8 million or $0.15 per share for the fourth quarter of 2016, primarily impacted by the additional $5.3 million in bad debt expense.

FULL YEAR 2017 FINANCIAL RESULTS

For the full year 2017, revenues were $29.1 million as compared to $27.0 million for the full year 2016. Gross margin for the twelve months ended December 31, 2017 was 37.9% compared to 36.8% in the same period last year, an improvement of 1.1 percentage points. Total operating expenses increased approximately $3.0 million to $29.7 million for full year 2017. The Company recorded a total of $5.3 million in bad debt expense in 2017. Net loss was $20.9 million or $1.01 per share for 2017, compared to a net loss of $15.8 million or $0.87 per share for the corresponding year-ago period.

Cash and cash equivalents totaled $9.5 million, net of $1.0 million in restricted cash, as of December 31, 2017.