On March 7, 2019 Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) reported financial results for the fourth quarter and year ended December 31, 2018 (Press release, Sunesis, MAR 7, 2019, View Source [SID1234534114]). Loss from operations for the three months and year ended December 31, 2018 was $5.8 million and $25.7 million. As of December 31, 2018, cash and cash equivalents totaled $13.7 million. Subsequent to the end of the quarter, the company raised $20 million in gross proceeds from concurrent underwritten public offerings in January.

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"We began 2019 by announcing the move into the 100 mg cohort for our Phase 1b/2 trial of vecabrutinib, an important milestone as we continue to believe that 100 – 300 mg will be the potentially therapeutic dose levels," said Dayton Misfeldt, Interim Chief Executive Officer of Sunesis. "To date, we have seen an encouraging safety profile, evidence of pharmacodynamic activity and some improvements in clinical symptoms in CLL and other B cell cancer patients both with and without BTK C481 mutations. We are targeting an update on our ongoing vecabrutinib trial at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress (EHA) (Free EHA Whitepaper) in June 2019. In addition, in January, we completed an equity offering with leading biotechnology investors that extends our runway through important clinical milestones."

Recent Highlights

Announced Advancement into 100mg Cohort. In January 2019, the Company announced that it had opened the 100 mg cohort in the Phase 1b/2 trial of its non-covalent BTK inhibitor vecabrutinib in adults with relapsed/refractory chronic lymphocytic leukemia (CLL) and other B-cell malignancies.

The latest protocol amendment, approved by most sites in February 2019, allows for upfront enrollment of up to 6 evaluable patients into a cohort, and we have taken advantage of this to allocate additional slots for the 100mg cohort. By studying more patients and collecting more data, we can better characterize vecabrutinib’s profile at this dose level.

Completion of $20 million Financing. In January, Sunesis announced the completion of an equity financing with net proceeds of approximately $18.4 million. The financing attracted participation from leading biotechnology investors and will allow Sunesis to advance vecabrutinib through important clinical milestones as we explore the potentially active dose levels.

Presentation of Preliminary Data at the ASH (Free ASH Whitepaper) Annual Meeting. In December 2018, Sunesis presented preliminary data from the Phase 1b/2 clinical trial of its non-covalent BTK inhibitor vecabrutinib in adults with relapsed/refractory chronic lymphocytic leukemia (CLL) and other B-cell malignancies.

Financial Highlights

Cash and cash equivalents totaled $13.7 million as of December 31, 2018, as compared to $31.8 million as of December 31, 2017. The decrease of $18.1 million was primarily due to $24.4 million of net cash used in operating activities, partially offset by $6.3 million in net proceeds from issuance of common stock.

Revenue was $0.2 million in 2018 as compared to $0.7 million in 2017, primarily due to deferred revenue related to the Royalty Agreement with RPI Finance Trust, which was fully amortized to revenue in March 2017.

Research and development expense was $3.3 million and $14.6 million for the three months and year ended December 31, 2018, as compared to $3.7 million and $21.5 million for the same periods in 2017. The decreases in 2018 were primarily due to the 2017 $2.5 million Biogen payment, a $2.8 million decrease in professional services related to the 2017 vosaroxin regulatory filing with the European Medicines Agency, and a $1.8 million decrease in salary and related expenses, partially offset by an increase in clinical expenses of $0.5 million for work related to the development of vecabrutinib.

General and administrative expense was $2.5 million and $11.3 million for the three months and year ended December 31, 2018, as compared to $2.8 million and $13.5 million for the same periods in 2017. The decreases in 2018 were primarily due to a $1.4 million decrease in professional services, a $0.5 million decrease in salary and related expenses, and a $0.3 million decrease in vosaroxin commercial expenses.

Interest expense was $0.3 million and $1.2 million for the three months and year ended December 31, 2018, as compared to $0.3 million and $1.4 million for the same periods in 2017. The decrease in 2018 was primarily due to the decrease in the outstanding notes payable.

Cash used in operating activities was $24.4 million for the year ended December 31, 2018, as compared to $36.1 million for the same period in 2017. Net cash used in operating activities in 2018 resulted primarily from the net loss of $26.6 million and changes in operating assets and liabilities of $0.6 million, offset by net adjustments for non-cash items of $2.8 million.

Loss from operations was $5.8 million and $25.7 million for the three months and year ended December 31, 2018, as compared to $6.4 million and $34.4 million for the same periods in 2017. Net loss was $6.0 million and $26.6 million for the three months and year ended December 31, 2018, as compared to $6.6 million and $35.5 million for the same periods in 2017.

Conference Call Information

Sunesis will host a conference today at 4:30 p.m. Eastern Time. The call can be accessed by dialing (844) 296-7720 (U.S. and Canada) or (574) 990-1148 (international) and entering passcode 6225859. To access the live audio webcast, or the subsequent archived recording, visit the "Investors and Media – Calendar of Events" section of the Sunesis website at www.sunesis.com. The webcast will be recorded and available for replay on the company’s website for two weeks.

On March 7, 2019 INSYS Therapeutics, Inc. (NASDAQ: INSY), a leader in the development, manufacture and commercialization of pharmaceutical cannabinoids and spray technology, reported financial results for its fourth quarter and full year ended Dec. 31, 2018 (Press release, Insys Therapeutics, MAR 7, 2019, View Source [SID1234534113]).

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RECENT HIGHLIGHTS

Advancing strategic alternatives review process for opioid-related assets to the next stage and evaluating initial interest by numerous parties

Achieved net revenue of $16.4 million in the fourth quarter of 2018

Advanced R&D programs with a $14.4 million investment in the fourth quarter of 2018:

Completed dose-finding PK study data for epinephrine nasal spray

Completed juvenile nonclinical toxicity study for naloxone nasal spray

Continued enrollment of company-sponsored CBD clinical studies:

Childhood absence epilepsy (Phase 2)

Prader-Willi syndrome (Phase 2)

Infantile Spasms (Phase 3)

Participated in FDA Advisory Committee Meeting addressing co-prescribing naloxone

Presented long-term safety study data of CBD in refractory pediatric epilepsy at the American Epilepsy Society Meeting

Presented poster on epinephrine at American Academy of Allergy, Asthma & Immunology Annual Meeting

Expanded collaborative partnership with University of California San Diego’s Center for Medicinal Cannabis Research (CMCR) to study the company’s cannabidiol (CBD) oral solution in anxiety in anorexia nervosa

Received IND acceptance to study CBD in Autism in collaboration with CMCR

"In 2018 we made progress in our transformation to further establish the company as a leader in the development of pharmaceutical-grade cannabinoids and spray technology, and move beyond

our legacy business," said Saeed Motahari, president and chief executive officer of INSYS Therapeutics. "2019 will be a year of delivering two new drug applications for two life-saving indications, strategically investing in our pipeline as well as continuing to reduce our operating expenses."

Motahari concluded, "We previously announced plans to undertake a strategic alternative review process for our opioid-related assets. We are in active negotiations with multiple parties regarding the potential divestiture of SUBSYS, and will update the market when we are able to do so. We anticipate that this transaction will require shareholder approval. Furthermore, we hired Lazard in the fourth quarter to advise us on our capital planning and strategic alternatives."

Financial & Operating Highlights

Net revenue for the fourth quarter of 2018 was $16.4 million, compared to $31.5 million for the revised fourth quarter of 2017, driven primarily by declines in the TIRF market

Gross margin was 84.0 percent for the fourth quarter of 2018, compared to 85.4 percent in the same revised period of 2017

Sales and marketing investment was $5.9 million for the fourth quarter of 2018, compared to $7.1 million for the revised fourth quarter of 2017 as a result of cost controls that were executed in the second half of 2018

Research and development investment decreased to $14.4 million for the fourth quarter of 2018, compared to $16.4 million for the revised fourth quarter of 2017 due to the timing of new drug application fees

General and administrative expense of $9.9 million for the fourth quarter of 2018 declined compared to $14.6 million in the revised fourth quarter of 2017 as a result of further cost reductions

Legal expense increased to $16.5 million for the fourth quarter of 2018, compared to $5.1 million in the revised fourth quarter of 2017, as a result of the company’s legal proceedings, including expenses associated with indemnification of former executives in connection with their ongoing trials. Management is disputing the reasonableness of certain indemnification-related expenses from Q4 and prior periods.

The company accrued $16.0 million for legal settlement expenses in the fourth quarter of 2018 compared to $4.4 million in the revised fourth quarter of 2017

Income tax benefit of $2.4 million for the fourth quarter of 2018 compared to an expense of $25.7 million during the revised fourth quarter of 2017

Net loss for the fourth quarter of 2018 was ($46.3 million), or ($0.62) per basic and diluted share, compared to a net loss of ($45.9 million), or ($0.63) per basic and diluted share, for the

revised fourth quarter of 2017. Adjusted net loss for the fourth quarter of 2018 was ($0.37) per basic and diluted share.

Adjusted EBITDA loss for the fourth quarter of 2018 was ($28.7 million), compared to Adjusted EBITDA loss of ($11.5 million) in the prior-year revised quarter. The reconciliation of net income to Adjusted EBITDA is included at the end of this news release.

The company had $104.1 million in cash, cash equivalents and short-term and long-term investments with no debt outstanding as of Dec. 31, 2018

Prior Period Accounting Adjustments

As reported in the financial results for the third quarter ended Sept. 30, 2018 and as disclosed in the company’s Form 10-Q for the period ended Sept. 30, 2018, the Dec. 31, 2017 financial information was revised for the correction of errors.

Webcast Information

A conference call is scheduled for 5:00 p.m. Eastern Standard Time on Mar. 7, 2019, to discuss the financial and operational results for the fourth quarter and full year 2018. Interested parties can listen to the call live as it occurs via the company’s website, View Source, on the Investors section’s Presentations & Events page; or by dialing 844-263-8304 (from inside the U.S.) or 213-358-0958 (from outside the U.S.), and using the Conference ID 9498523. A webcasted replay of the call will be available on the site a few hours after the event.

On March 7, 2019 XOMA Corporation (Nasdaq: XOMA) reported its fourth quarter and full-year 2018 financial results and business highlights (Press release, Xoma, MAR 7, 2019, View Source [SID1234534112]).

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"In 2018, we completed the first transaction under our royalty-aggregator business model, adding seven assets being developed by Merck and Incyte, bringing our royalty license portfolio to 45 assets. We added $20 million of capital and established a $20 million credit facility to strengthen our balance sheet and to continue building our royalty portfolio. We believe XOMA is in a healthy financial position, and we are focused on delivering shareholder value," stated Jim Neal, Chief Executive Officer of XOMA. "In early 2019, we added Barbara Kosacz to our Board of Directors; her legal expertise in analyzing, structuring, and negotiating pharmaceutical and biotechnology license agreements will be invaluable as we execute on our business strategy."

Business Highlights

XOMA continued making significant progress to position the Company for long-term growth, while strengthening its balance sheet in multiple ways during 2018.

Acquired a milestone and royalty interest in seven immuno-oncology assets being developed by Merck and Incyte.

Completed a $20 million rights offering with XOMA stockholders including BVF Partners, LP.

Secured $20 million credit facility with Silicon Valley Bank.

Reduced operating expenses to historic lows, reflecting our new low-cost infrastructure.

Strengthened the Board of Directors and leadership team.

2018 Updates About Partnered Assets in Development

"During its R&D Update on November 25, 2018, Novartis highlighted 26 potential blockbuster drug candidates from their 340 programs under development. XOMA has up to double-digit royalty interests on two of those potential blockbuster assets," concluded Mr. Neal.

Novartis-licensed assets:

Novartis announced gevokizumab will enter oncology clinical studies.

Novartis has listed Phase 2 trials for CFZ533 in four separate indications on ClinicalTrials.gov.

Financial Results

XOMA recorded total revenues of $1.7 million for the fourth quarter of 2018, compared to $5.4 million for the fourth quarter of 2017. For the full year of 2018, XOMA recorded revenues of $5.3 million, compared to $52.7 million for the full year of 2017. Revenues for the full year of 2017 reflect $40.2 million of licenses and collaborative fee revenue received in connection with the Company’s 2017 license agreements with Novartis and a $10.0 million clinical development milestone payment from Novartis related to another therapeutic candidate.

Research and development (R&D) expenses were $0.2 million for the fourth quarter of 2018, compared to $0.7 million for the fourth quarter of 2017. Research and development expenses for the full year of 2018 were $1.7 million, compared to $7.9 million for the same period in 2017. The decrease in R&D expenses for the full year of 2018, as compared with 2017, was primarily due to the implementation of our royalty-aggregator business model during the first quarter of 2017, at which time the Company ceased substantially all development activities. The decrease primarily consisted of $1.9 million in clinical trial costs, $1.4 million in consulting costs, $1.2 million in the allocation of facilities costs, $0.5 million in stock-based compensation, and $0.4 million in salaries and related expenses. The decrease in allocation of facilities costs is a result of a decreased proportion of R&D employees due to our restructuring activities in late 2016 and June 2017.

General and administrative (G&A) expenses were $4.3 million for the fourth quarter of 2018, compared to $6.7 million for the fourth quarter of 2017. General and administrative expenses were $18.6 million for the full year of 2018, compared to $24.3 million for the full year of 2017. The decrease of $5.7 million for the full year of 2018, as compared with the full year of 2017, was primarily due to decreases of $2.9 million in stock-based compensation, $2.1 million in consulting services, and $0.5 million in information technology costs, partially offset by an increase of $1.2 million in the allocation of facilities costs due to a greater proportion of G&A personnel compared to R&D personnel after our restructuring activities.

For the years ended December 31, 2018 and 2017, XOMA recorded $1.9 million and $3.4 million, respectively in charges related to severance, other termination benefits, outplacement services, and lease-related charges associated with restructuring activities.

For the years ended December 31, 2018 and 2017, XOMA recorded other income of $4.3 million and $1.1 million, respectively. Other income in both periods included income received in relation to the Company’s disposition of its biodefense business to Ology Bioservices in March 2015. During the year ended December 31, 2018, XOMA also received $1.8 million in sublease income. This was partially offset by a loss of $0.6 million for the decrease in fair value of long-term equity securities that consisted of shares of Rezolute’s common stock. For the year ended December 31, 2017, XOMA realized a foreign exchange loss of $1.6 million related to re-measurement of the Servier Loan which was paid in 2017 and a sublease loss of $0.8 million, offset by a $1.2 million gain on the sale and disposal of equipment located in one of its leased facilities.

Net loss for the fourth quarter of 2018 was $3.0 million, compared to net loss of $1.3 million for the fourth quarter of 2017. Net loss for the full year of 2018 was $13.3 million, compared to net income of $14.6 million for the full year of 2017. The significant net income for the full year of 2017 was due primarily to the increase in total revenues as previously discussed.

On December 31, 2018, XOMA had cash and cash equivalents of $45.8 million. The Company ended December 31, 2017, with cash and cash equivalents of $43.5 million. The Company’s current cash and cash equivalents are expected to be sufficient to fund its operations for multiple years.

On March 7, 2019 BioTime, Inc. (NYSE American and TASE: BTX), a clinical-stage biotechnology company focused on degenerative diseases, reported that it will report its fourth quarter and full year 2018 financial and operating results on Thursday, March 14th, 2019, following the close of the U.S. financial markets (Press release, BioTime, MAR 7, 2019, View Source;p=RssLanding&cat=news&id=2390475 [SID1234534111]). BioTime management will also host a conference call and webcast on Thursday, March 14th, 2019, at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its fourth quarter and full year 2018 financial results and to provide a business update.

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Interested parties may access the conference call by dialing (866) 888-8633 from the U.S. and Canada and (636) 812-6629 from elsewhere outside the U.S. and should request the "BioTime Inc. Call". A live webcast of the conference call will be available online in the Investors section of BioTime’s website. A replay of the webcast will be available on BioTime’s website for 30 days and a telephone replay will be available through March 21st, 2019, by dialing (855) 859-2056 from the U.S. and Canada and (404) 537-3406 from elsewhere outside the U.S. and entering conference ID number 1091719.

On March 7, 2019 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported its financial results for the fourth quarter ended December 31, 2018 (Press release, Syndax, MAR 7, 2019, View Source [SID1234534110]). In addition, the Company provided a clinical and business update. As of December 31, 2018, Syndax had $80.9 million in cash, cash equivalents and short-term investments.

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"We expect the coming months to be a very exciting, milestone-rich time for Syndax as we continue to work towards our mission of realizing a future in which cancer patients live longer and better lives than previously possible," said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. "We remain highly encouraged by the potential for a positive overall survival readout in E2112, our Phase 3 registration trial of entinostat plus exemestane in HR+, HER2- breast cancer, and expect the next interim analysis in the second quarter. As a reminder, any positive overall survival result would allow us to file for full regulatory approval in an indication for which existing therapies have failed to show a survival benefit. In addition, we continue to expect to file an IND in the second quarter for our targeted therapy, SNDX-5613, an inhibitor of the Menin-MLL interaction. Preclinical data from our Menin inhibitor program has provided strong, consistent support for the therapeutic potential of this class in patients with genetically-defined acute leukemias, a disease area lacking effective options."

Syndax also reported that both ENCORE 602, the Phase 1b/2 clinical trial evaluating the combination of entinostat plus Genentech’s PD-(L)1 inhibitor, TECENTRIQ (atezolizumab), in patients with triple negative breast cancer (TNBC), and ENCORE 603, the Phase 1b/2 trial evaluating entinostat in combination with BAVENCIO (avelumab), an anti-PD-(L)1 co-developed and co-commercialized by Merck KGaA Darmstadt, Germany and Pfizer, in patients with ovarian cancer, failed to meet their respective primary endpoints of demonstrating an improvement in progression free survival (PFS).

With results across the entire ENCORE program now in hand, Syndax has decided to defer advancement of the entinostat-PD-1 combination program, including the previously announced ENCORE 607 registration trial in non-small cell lung cancer (NSCLC). Going forward, the Company will primarily focus its resources on advancing entinostat in HR+ breast cancer and SNDX-5613, a Menin inhibitor being developed for genetically-defined population of acute leukemias. Following availability of positive E2112 OS results, the Company will determine whether to advance its entinostat-PD-1 combination programs into one or more registration trials.

Dr. Morrison added, "While we are encouraged by ENCORE 601 entinostat-KEYTRUDA combination data in NSCLC and melanoma which suggests that entinostat has the ability to overcome resistance in PD-1 refractory patients, we believe that it is in the best interest of our stakeholders to prioritize our resources ahead of the E2112 OS readout, at which time we will make a determination on next steps for the I-O combination program. We are highly committed to advancing the balance of our pipeline programs, with an emphasis on our targeted therapy, SNDX-5613, and the E2112 registrational trial for HR+ breast cancer."

Pipeline Updates

Entinostat

The Company continues to anticipate the next interim OS analysis for E2112, its NCI-sponsored, ECOG-ACRIN led Phase 3 registration trial of entinostat, a Class I selective HDAC inhibitor, plus exemestane in advanced hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+, HER2-) breast cancer, in the second quarter of 2019. Additional interim analyses will be conducted by ECOG-ACRIN approximately every six months until either an OS benefit is observed, or the final target number of events occur. Any positive OS assessment would enable the Company to file for full regulatory approval. The E2112 trial design was informed by the Phase 2b ENCORE 301 trial, the results of which led to entinostat’s Breakthrough Therapy designation in HR+, HER2- breast cancer, in which patients receiving the entinostat/exemestane combination demonstrated a statistically significant OS benefit.

As previously announced, data from the NSCLC and melanoma cohorts of the ENCORE 601 trial will each be featured during oral presentations at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Meeting later this month. Data to be presented will include the Company’s most recent insights into the potential mechanisms that allow entinostat to enhance the benefit of immune checkpoint therapy.

The Phase 1b/2 ENCORE 603 trial, which evaluated entinostat in combination with avelumab in patients with heavily pretreated advanced epithelial ovarian cancer, and the Phase 1b/2 ENCORE 602 trial, which evaluated entinostat in combination with atezolizumab in patients with PD-1 naïve, previously treated TNBC, each failed to meet its respective primary endpoint of a statistically significant improvement in PFS.

Based on the activity observed to date, the Company has decided not to advance the ENCORE 601 cohort of patients with microsatellite stable colorectal cancer (MSS-CRC) to the second stage of the trial.

SNDX-5613

Preclinical data supporting the Company’s Menin-Mixed Lineage Leukemia (MLL) inhibitor program were presented during an oral session at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2018.

The Company continues to expect to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for its Menin inhibitor, SNDX-5613, in the second quarter of 2019, with the initiation of a Phase 1 clinical trial in a defined subset of acute leukemias patients expected to follow.

SNDX-6352

The Company continues to anticipate initial results from the Phase 1 dose escalation trial of SNDX-6352, the Company’s anti-CSF-1R monoclonal antibody, in patients with chronic graft versus host disease (cGVHD) in the second half of the year. The objectives of this trial are to evaluate the safety and preliminary efficacy of SNDX-6352 in cGVHD and to identify a recommended Phase 2 dose and schedule.

The Company continues to anticipate identifying a recommended Phase 2 dose and schedule for SNDX-6352 monotherapy and in combination with IMFINZI (durvalumab), AstraZeneca’s human monoclonal antibody directed against PD-L1, in the second quarter of 2019. The dose selections will be based on the results of the ongoing Phase 1/1b ascending dose trial evaluating the safety of SNDX-6352 alone or in combination with durvalumab.

Fourth Quarter 2018 Financial Results

As of December 31, 2018, Syndax had cash, cash equivalents and short-term investments of $80.9 million and 26.8 million shares issued and outstanding.

License fee revenue decreased to $0.4 million in the fourth quarter 2018 from $1.2 million for the prior year fourth quarter, and for 2018 decreased to $1.5 million compared to $2.1 million for the prior year. The decreases are due to the ratable recognition of a $5.0 million payment from KHK for the achievement of a development milestone in the fourth quarter of 2017.

Fourth quarter 2018 research and development expenses decreased to $15.8 million from $16.6 million, and for the full year increased to $60.1 million compared to $48.2 million for 2017. The fourth quarter decrease was primarily due to expensing a payment of $5.0 million to Allergan to acquire SNDX-5613 in the fourth quarter of 2017, offset by an increase in SNDX-6352 manufacturing expenses. The increase for the full year was primarily due to increased expenses for SNDX-6352 manufacturing, SNDX-5613 program expenses and increased headcount, offset by the payment of $5.0 million to Allergan in 2017.

General and administrative expenses for the fourth quarter 2018 decreased to $3.9 million from $4.1 million, and, for the year ended December 31, 2018 increased to $17.3 million compared to $15.9 million for the prior year. The full year increase was primarily due to increased pre-commercialization expenses.

For the three months ended December 31, 2018, Syndax reported a net loss attributable to common stockholders of $18.8 million or $0.70 per share compared to $19.1 million or $0.80 per share for the prior year period. For the year ended December 31, 2018, Syndax reported a net loss attributable to common stockholders of $74.0 million or $2.92 per share, compared to $60.8 million or $2.90 per share for the prior year.

Financial Guidance

Today the Company provided operating expense guidance for the first quarter and full year 2019. For the first quarter and full year 2019, research and development expenses are expected to be $11 to $13 million and $46 to $50 million, respectively, and total operating expenses are expected to be $15 to $17 million and $60 to $64 million, respectively.

Conference Call and Webcast

In connection with the earnings release, Syndax’s management team will host a conference call and live audio webcast at 4:30 p.m. ET today, Thursday, March 7, 2019.

The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company’s website at www.syndax.com. Alternatively, the conference call may be accessed through the following:

Conference ID: 8252397
Domestic Dial-in Number: 855-251-6663
International Dial-in Number: 281-542-4259
Live Webcast: View Source

For those unable to participate in the conference call or webcast, a replay will be available for 30 days on the Investors section of the Company’s website, www.syndax.com.