On March 8, 2018 Cerus Corporation (Nasdaq: CERS) reported financial results for the fourth quarter and year ended December 31, 2017 (Press release, Cerus, MAR 8, 2018, View Source [SID1234524557]).

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Recent developments and highlights include:

Reported record fourth quarter product revenue of $16.2 million, an increase of 60% compared to the same period in the year prior.
Established 2018 annual product revenue guidance of $51 million to $53 million, which would represent a 17% to 22% increase over 2017 reported product revenue.
Successfully met primary safety and efficacy endpoints in SPARC, Cerus’ European Phase 3 clinical trial evaluating INTERCEPT red cell transfusions in thalassemia patients.
Completed an underwritten public offering of common stock raising gross proceeds of $57.5 million.
Advanced release assay for commercial manufacturing of the S303 compound used in the INTERCEPT red blood cell system to enable H2 2018 CE Mark submission.
"As we reported in our January 8, 2018 press release, we experienced a strong finish to 2017 with fourth quarter results exceeding our expectations. We saw robust sales activity in multiple geographies including France, the U.S., and the Middle East. In addition, we continue to make progress on the final CMC activities needed for the planned INTERCEPT red blood cell system CE Mark submission which will include data from the SPARC clinical study. In the U.S. we received IDE approval from the FDA to initiate our second Phase 3 RBC study," said William ‘Obi’ Greenman, Cerus’ president and chief executive officer. "With the $57.5 million of gross proceeds and the remaining borrowing availability under our growth capital facility, combined with BARDA funding, we believe we are now well capitalized to focus on commercial execution and on progressing our pipeline opportunities from late stage development to potential market launch."

Revenue

Product revenue for the fourth quarter of 2017 was $16.2 million, compared to $10.1 million during the same period in 2016. Product revenue for the year ended December 31, 2017 was $43.6 million, compared to $37.2 million for the year ended December 31, 2016. The increases in reported product revenue were driven by year-over-year increases in platelet kit demand, both in international and domestic markets, partially offset by declines in plasma kits and illuminator sales. Growth in sales from France and the U.S. were the primary drivers of the increased platelet kit sales in both periods. Demand for platelet kits was up more than 100% when comparing the fourth quarter of 2017 to the same period in 2016, and up almost 40% for the full year 2017 compared to 2016.

Government contract revenue from our Biomedical Advanced Research and Development Authority (BARDA) agreement was $2.4 million in the fourth quarter of 2017 compared to $1.8 million during the same period in 2016. Government contract revenue from our BARDA agreement for the year ended December 31, 2017 was $7.8 million, compared to $2.1 million for the year ended December 31, 2016.

Gross Margins

Gross margins on product revenue for the fourth quarter of 2017 were 44%, compared to 45% for the fourth quarter of 2016. Gross margins for the year ended December 31, 2017 were 48%, compared to 45% in the same period in 2016.

Despite the more than a 100% increase in demand for platelet kits, gross margins on product revenue for the fourth quarter of 2017 was relatively consistent compared to the same period in 2016 due to fewer illuminator sales in the fourth quarter of 2017 compared to the same period in 2016, as well as the impact of pricing from higher volume platelet contracts. Gross margin on product revenue for the full-year 2017 increased due to the increase in demand for higher margin platelet disposable kits and favorable foreign exchange rates. Going forward, the Company expects to continue to realize economies of scale and lower cost of goods sold from its primary kit manufacturing agreement due to tiered pricing, which declines as production volume tiers are achieved.

Operating Expenses

Total operating expenses were $20.3 million and $86.3 million for the quarter and year ended December 31, 2017, compared to $21.5 million and $80.4 million for the quarter and year ended December 31, 2016, respectively.

Selling, general, and administrative (SG&A) expenses for the fourth quarter of 2017 were $12.5 million compared to $12.4 million for the fourth quarter of 2016. SG&A expenses for the year ended December 31, 2017 were $52.4 million compared to $48.8 million in the same period in 2016. The increase in SG&A expenses was due largely to increased commercial activity in the U.S.

Research and development (R&D) expenses for the fourth quarter of 2017 were $7.8 million compared to $8.8 million for the fourth quarter of 2016. R&D expenses in the quarter declined primarily due to the timing of activities related to the BARDA agreement. R&D expenses for the year ended December 31, 2017 were $33.7 million compared to $31.3 million in the same period in 2016. The increase in R&D expenses was primarily tied to increased headcount costs and costs tied to the clinical development of our INTERCEPT red blood cell program, the pursuit of supplemental approvals for the platelet and plasma systems, and activities related to our BARDA agreement.

Operating and Net Loss

Operating losses during the fourth quarter of 2017 were $10.9 million, compared to $15.1 million during the fourth quarter of 2016, and $57.5 million compared to $61.4 million for years ended December 31, 2017 and 2016, respectively.

Net loss for the fourth quarter of 2017 was $11.5 million, or $0.10 per diluted share, compared to a net loss of $13.5 million, or $0.13 per diluted share, for the fourth quarter of 2016. Net loss for the year ended December 31, 2017, was $60.6 million, or $0.56 per diluted share, compared to a net loss of $62.9 million, or $0.62 per diluted share, for the same period of 2016.

Cash, Cash Equivalents and Investments

At December 31, 2017, the Company had cash, cash equivalents and short-term investments of $60.7 million compared to $71.6 million at December 31, 2016.

At December 31, 2017, the Company had approximately $29.8 million in outstanding debt under its loan agreement with Oxford Finance. The loan agreement provides for an additional $10 million term loan and an extension of the interest only period upon the Company achieving pre-determined revenue levels.

In January 2018, the Company completed an underwritten public offering of its common stock for gross proceeds of $57.5 million, before deducting offering expenses payable by the Company.

QUARTERLY CONFERENCE CALL

The Company will host a conference call and webcast at 4:15 p.m. Eastern time today to discuss its financial results and provide a general business overview and outlook. To access the live webcast, please visit the Investor Relations page of the Cerus website at View Source Alternatively, you may access the live conference call by dialing (866) 235-9006 (U.S.) or (631) 291-4549 (international).

A replay will be available on the Company’s website, or by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and entering conference ID number 3395359. The replay will be available approximately three hours after the call through March 22, 2018

On March 8, 2018 Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) reported financial results and provided a business update for the fourth quarter and full-year 2017 (Press release, Progenics Pharmaceuticals, MAR 8, 2018, View Source [SID1234524570]).

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"2017 was a year of strong progress for our targeted oncology pipeline programs, capped by the FDA’s acceptance for review of the New Drug Application (NDA) for AZEDRA," said Mark Baker, Chief Executive Officer of Progenics. "AZEDRA has the potential to be a transformative treatment option for patients with malignant, recurrent, and/or unresectable pheochromocytoma and paraganglioma, rare and life-threatening neuroendocrine tumors for which there are no approved therapies in the U.S. As we approach the FDA’s action date, we are readying our commercial organization for launch upon potential approval."

Mr. Baker continued, "We also continue to build momentum in advancing our development-stage PSMA-targeted radiopharmaceutical programs, which are designed to find, fight and follow prostate cancer. We have completed enrollment in our Phase 3 study for 1404, with results anticipated in the third quarter, and we expect to complete our current Phase 2/3 study for PyL in the second half of this year."

Fourth Quarter and Recent Key Business Highlights

AZEDRA, Ultra-orphan radiotherapeutic candidate

Action Date for AZEDRA New Drug Application (NDA) Set for April 30th
In December 2017, Progenics announced that the FDA accepted for review the NDA for AZEDRA in patients with malignant, recurrent, and/or unresectable pheochromocytoma and paraganglioma, rare neuroendocrine tumors for which there are currently no approved treatment options in the U.S. The FDA granted Progenics’ request for Priority Review and has set an action date of April 30, 2018 under the Prescription Drug User Fee Act (PDUFA). AZEDRA holds Breakthrough Therapy designation and Orphan Drug status, as well as Fast Track designation.
Clinical Data from Pivotal Phase 2b AZEDRA Study Presented at Major Medical Meetings
In October 2017, Progenics presented the positive results from its pivotal Phase 2b study evaluating AZEDRA at the North American Neuroendocrine Tumor Society (NANETS) 2017 Annual Symposium and the 30th Annual Congress of the European Association of Nuclear Medicine (EANM). Progenics also plans to present biochemical tumor marker data from this study at the upcoming Endocrine Society (ENDO) Annual Meeting in March 2018.
PSMA-Targeted Prostate Cancer Pipeline

Enrollment Complete in Phase 3 Study of 1404
In January 2018, Progenics announced the completion of enrollment in its Phase 3 study of 1404, a PSMA-targeted small molecule SPECT/CT imaging agent designed to visualize prostate cancer. The study enrolled approximately 450 patients in the U.S. and Canada with newly-diagnosed or low-grade prostate cancer, whose biopsy indicates a histopathologic Gleason grade of ≤ 3+4 severity and/or are candidates for active surveillance. Top-line data is expected in the third quarter of 2018.
Phase 2/3 Study of PyL Ongoing
Progenics continues to enroll patients in the Phase 2/3 study of PyL, a PSMA-targeted PET/CT imaging agent, evaluating diagnostic accuracy in patients with recurrent and/or metastatic prostate cancer. The Company expects to complete enrollment of this study in the second half of 2018 and initiate a second Phase 3 study in patients with biochemical recurrence of prostate cancer.
Enrollment Ongoing in Phase 1 Study for 1095
Progenics continues to enroll patients in the Phase 1 open-label dose escalation study of 1095, a small molecule radiotherapeutic that selectively binds to PSMA, in patients with metastatic castration-resistant prostate cancer (mCRPC) who have demonstrated tumor avidity to 1095.
Initiation of Phase 1 Study for PSMA-TTC Expected in 2018
Progenics expects its partner Bayer to initiate a Phase 1 study of PSMA-Targeted Thorium Conjugate (PSMA-TTC) in patients with mCRPC by year end 2018. Bayer was previously granted exclusive worldwide rights to develop and commercialize products using Progenics’s PSMA antibody technology in combination with Bayer’s alpha-emitting radionuclides.
RELISTOR, treatment for OIC (partnered with Valeant Pharmaceuticals International, Inc.)

RELISTOR Quarterly Net Sales Reached Record Level of $24.6 Million in Q4’17
Full-year 2017 net worldwide sales totaled $73.1 million as reported by our partner, Valeant. The fourth quarter 2017 net sales translated to $3.7 million in royalty revenue for Progenics, while the full year net sales resulted in $11.0 million in royalty revenue. Net sales of RELISTOR grew 44% over the prior quarter.
Fourth Quarter and Full-Year 2017 Financial Results

Fourth quarter 2017 revenue totaled $3.9 million, down from $4.7 million in the fourth quarter of 2016. Revenue for the 2017 period reflects RELISTOR royalty income of $3.7 million compared to $2.4 million in the corresponding period of 2016. The prior year period included milestone revenue of $2.0 million from Bayer for the collaboration of the Company’s PSMA antibody technology in combination with Bayer’s alpha-emitting radionuclides. The full-year 2017 revenue totaled $11.7 million, down from $69.4 million for the full-year of 2016, resulting primarily from the prior year milestone revenue of $50 million for the July 19, 2016 FDA approval of RELISTOR Tablets, and the recognition of $7 million in upfront and development milestone payments from Bayer.

Research and development expenses increased by $0.3 million and $5.0 million in the fourth quarter and full-year 2017, respectively, compared to the corresponding periods in 2016. The full-year increase resulted primarily from higher clinical costs for PyL and higher consulting expenses in preparation for the AZEDRA NDA filing, partially offset by lower clinical costs for AZEDRA. Fourth quarter and full-year general and administrative expenses increased by $2.2 million and $1.6 million, respectively, compared to the corresponding prior periods in 2016, primarily attributable to higher costs associated with building commercial capabilities in preparation for a potential AZEDRA approval and launch. Progenics also recorded non-cash adjustments of ($0.7 million) and $2.6 million in the fourth quarter and full-year 2017, respectively, related to changes in the fair value estimate of the contingent consideration liability. For the three months and year ended December 31, 2017, Progenics recognized interest expense of $1.2 million and $4.8 million, respectively, related to the RELISTOR royalty-backed loan.

In December 2017, the Tax Cuts and Jobs Act (the "Tax Act"), was signed into law. Among other provisions, the Tax Act reduces the U.S. federal statutory corporate income tax rate from 35% to 21% effective for 2018 and provides for an indefinite carryforward period for net operating losses. As a result, the Company recorded an income tax benefit of approximately $11.7 million in 2017, primarily related to the reduction in the federal tax rate and the use of the Company’s deferred tax liability related to indefinite-lived intangible assets (naked tax credit) as a source of income to release a portion of its valuation allowance recorded against deferred tax assets.

Net loss attributable to Progenics for the fourth quarter was $2.7 million or $0.04 per diluted share, compared to a net loss of $7.2 million or $0.10 per diluted share in the corresponding 2016 period. Net loss for the full-year 2017 was $51.0 million or $0.73 per diluted share, compared to net income of $10.8 million or $0.15 per diluted share for the full-year 2016.

Progenics ended the year with cash and cash equivalents of $90.6 million, reflecting a decrease of $7.7 million in the quarter and $48.3 million from 2016 year-end. In order to maintain a strong financial position, in the fourth quarter of 2017 and in January 2018, the Company raised $14.5 million in net proceeds from sales of its common stock under its "at-the-market" (ATM) facility, with $5.0 million received through December 31, 2017 and the remainder received in January.

Cerus has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Cerus, 2018, MAR 8, 2018, View Source [SID1234524550]).

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On March 8, 2018 Coherus BioSciences, Inc. (Nasdaq:CHRS), reviewed corporate events and reported financial results for the quarter and full year ended December 31, 2017 (Press release, Coherus Biosciences, MAR 8, 2018, View Source/phoenix.zhtml?c=253655&" target="_blank" title="View Source/phoenix.zhtml?c=253655&" rel="nofollow">View Source;p=RssLanding&cat=news&id=2337143 [SID1234524558]).

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Fourth Quarter and Full Year 2017 Financial Results:

Research and development (R&D) expenses for the fourth quarter of 2017 were $31.5 million compared to $59.0 million for the same period in 2016. R&D expenses for the fiscal year 2017 were $162.4 million, as compared to $254.4 million for the same period in 2016. The decrease in R&D expenses in the fourth quarter over the same period in 2016 was mainly due to the reduction in manufacturing, analytical and clinical costs associated with the CHS-0214 (etanercept (Enbrel) biosimilar candidate) and CHS-1420 (adalimumab (Humira) biosimilar candidate) programs. The decrease in R&D expenses in the fiscal year ended 2017 over the same period in 2016 was mainly attributable to a decrease in clinical development costs associated with the CHS-0214 and CHS-1420 programs. General and administrative (G&A) expenses for the fourth quarter of 2017 were $15.0 million, compared to $15.3 million for the same period in 2016. G&A expenses for the fiscal year 2017 were $71.3 million, as compared to $51.6 million for the same period in 2016. The increase in G&A expenses in 2017 were mainly attributable to salary and stock compensation costs associated with the hiring of personnel in the first half of 2017 to support the CHS-1701 (pegfilgrastim (Neulasta) biosimilar candidate) pre-commercial activities and costs related to legal and other professional services. Net loss attributable to Coherus for the fourth quarter of 2017 was ($49.1) million, or ($0.84) per share, compared to a net loss of ($75.9) million, or ($1.71) per share, for the same period in 2016. Net loss attributable to Coherus for 2017 was ($238.2) million, or ($4.48) per share, compared to a net loss of ($127.3) million, or ($3.04) per share, for 2016. Cash and cash equivalents and investments in marketable securities – short term totaled $126.9 million as of December 31, 2017, compared to $150.1 million as of September 30, 2017.
Guidance for 2018:
CHS-1701 (pegfilgrastim (Neulasta) biosimilar)

Anticipate resubmitting the biologics license application (BLA) directly after receipt of minutes post completion of FDA meetings concerning the complete response letter, completion of immunogenicity sample processing and integration of such data into the resubmission. Anticipate European approval opinion in the second half of 2018. Commercial partnering discussions are projected to continue for certain ex-U.S. territories. Anticipate U.S. commercial launch in the second half of 2018, dependent on regulatory review and approval timing.
CHS-3351 (ranibizumab (Lucentis) biosimilar) and CHS-2020 (Eylea biosimilar)

Initiate clinical development of CHS-3351. Continue preclinical development of CHS-2020.
CHS-1420 (adalimumab (Humira) biosimilar)

Pursue manufacturing objectives in support of a BLA. Prepare for partnering pursuant to a 2022 launch.
CHS-0214 (etanercept (Enbrel) biosimilar)

Expect the Patent Trial and Appeal Board of the USPTO to enter institution decisions with respect to two Inter Partes Review filings, by March 13, 2018 for patent 8,163,522, and by March 15, 2018 for the patent 8,063,182.
CHS-131 central nervous system anti-inflammatory asset

Anticipate a potential global license, dependent on outcome of certain preclinical studies.
Cash flow

Anticipate cash use in operations of approximately $30 – $35 million per quarter in the first half of 2018.

Conference Call Information
When: Thursday, March 8, 2018 at 4:30 p.m. ET
Dial-in: (844) 452-6826 (toll free) or (765) 507-2587 (International)
Conference ID: 7098068
Webcast: View Source
Please join the conference call at least 10 minutes early to register. The webcast will be archived on the Coherus website.

On March 8, 2018 Onconova Therapeutics, Inc. (NASDAQ: ONTX), a Phase 3 stage biopharmaceutical company focused on discovering and developing novel small molecule drug candidates to treat cancer, with a primary focus on Myelodysplastic Syndromes (MDS), reported a corporate update and financial results for the full year ended December 31, 2017 (Press release, Onconova, MAR 8, 2018, View Source [SID1234524567]).

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"The recently completed year was a pivotal period for rigosertib development programs in MDS. We achieved important goals across our full pipeline, highlighted by the recently announced promising interim analysis and the advancement of the INSPIRE pivotal trial for rigosertib, our lead Phase 3 clinical candidate. With no FDA approved therapies available for patients with higher-risk MDS who are refractory to hypomethylating agents, Onconova has taken a leadership position in this indication. Looking ahead, we now expect topline analysis to be concurrent with enrollment completion, which can be achieved in the first half of 2019," said Dr. Ramesh Kumar, President and Chief Executive Officer.

"We also announced three important collaborations in recent months. Regional licensing of our pre-IND stage next generation CDK 4/6 inhibitor for Greater China which we believe advnaces this program on the IND track and towards clinical data in 2019. Our collaboration with the National Cancer Institute for clinical development of rigosertib in children suffering from incurable inherited diseases (RASopathies) could provide Onconova with the opportunity to establish a rare disease development program. Finally, our licensing agreement for rigosertib in Latin America further expands the global commercial footprint of rigosertib, and is in addition to our existing partnership in Japan and Korea. Execution of these transactions we believe indicates the ability to leverage our late stage and pipeline assets to finance multiple programs. Based on the progress achieved in our oral rigosertib-azacitidine combination Phase 2 program in front-line MDS indications, we expect to secure additional collaborations and regional partnerships to help support a pivotal Phase 3 trial for oral rigosertib."

INSPIRE Trial of IV Rigosertib in 2nd Line Higher-risk (HR) MDS

Interim Analysis (IA)

· On January 17, 2018, Onconova announced that it is moving forward with its Phase 3 INSPIRE pivotal trial following the interim analysis and the Data Monitoring Committee’s (DMC) recommendation, together with unanimous approval by the Executive Committee overseeing this trial. The DMC recommended continuation of the trial with a one-time expansion in enrollment, using a pre-planned sample size re-estimation, consistent with the Statistical Analysis Plan.

· The expanded INSPIRE study will increase enrollment by adding 135 patients to the original target to reach a total enrollment of 360 patients.

· At the topline analysis of the INSPIRE trial, the primary endpoint of overall survival will be analyzed in both the ITT population and the Very High Risk (VHR) subgroup.

· In the INSPIRE trial enrollment so far, the predefined subgroup of VHR patients constitutes greater than 70% of patients enrolled to date.

·The Company remains blinded to the interim analysis results.

Trial Progress

· The INSPIRE study is open in more than 170 sites in 22 countries across four continents.

· More than half of the expanded study is now enrolled.

The Company is planning to add sites in Europe and new territories, including in Latin America, in concert with our new partner Pint Pharma ("Pint").

·The INSPIRE trial was designed with stringent selection criteria so as to identify a more homogenous MDS patient population. Accordingly, extensive eligibility verification and trial site education are integral to the Company’s plan.

Oral Rigosertib in Combination with Azacitidine for 1st-line HR-MDS

Pivotal Phase 3 Trial Protocol

·phase 2 Expansion Trial is expected be fully enrolled this month with the addition of more than 40 patients.

· Onconova plans to present initial data from this study at a scientific conference in 2018, highlighting the results of dose selection and optimization of the combination regimen.

On March 2, 2018, Onconova presented data relating to the mechanism of action of rigosertib in combination with azacitidine at the AACR (Free AACR Whitepaper) Special Conference. The results suggested potential novel clinical strategies to improve outcomes for patients with higher-risk MDS and reversal of resistance to treatment with epigenetic therapies.

Progress in Business Development around Rigosertib and Pipeline Products

Onconova and Pint Pharmaceutical Announce Licensing Agreement for Rigosertib in Latin America

On March 5, 2018, Onconova and Pint announced that they had entered into a Latin American licensing agreement for rigosertib. Pint is a private, European-based pharmaceutical company focused on the development, registration and commercialization of specialty-based treatments for the Latin American market.
Under the terms of the agreement, Pint will make an investment in Onconova totaling up to $2.5 million by purchasing shares at a premium to market. In addition, Pint will make potential additional regulatory, development and sales-based milestone payments to Onconova of up to $42.75 million and pay double digit tiered royalties on net sales in Latin America.

Rigosertib Collaboration for Pediatric RASopathies

On January 4, 2018, Onconova announced that it had entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), part of the National Institutes of Health. Under the terms of the CRADA, the NCI will conduct research, including preclinical laboratory studies and a clinical trial, on rigosertib in pediatric cancer associated RASopathies. The RASopathies are a group of rare diseases which share a well-defined molecular basis in expression or defects involving Ras Effector Pathways.

License and Collaborative Development Agreement with HanX Biopharmaceuticals for ON 123300

·On December 19, 2017, Onconova announced the signing of a license and collaboration agreement with HanX Biopharmaceuticals, Inc., a company focused on development of novel oncology products, for the further development, registration and commercialization of ON 123300 in China. ON 123300 is a first-in-class dual inhibitor of CDK4/6 + ARK5, which is currently in advanced pre-clinical development. This compound has the potential to overcome the limitations of current generation CDK 4/6 inhibitors.

Under the terms of the agreement, Onconova will receive an upfront payment, and is eligible to receive potential regulatory and commercial milestone payments, as well as royalties on Chinese sales. HanX will provide all funding required for Chinese IND enabling studies performed for Chinese Food and Drug Administration IND approval. The Companies also intend for these studies to comply with US Food and Drug Administration (FDA) standards. Accordingly, such studies may be used by Onconova for an IND filing with the FDA. Onconova will maintain global rights outside of China.

Pre-clinical Stage CDK4/6 + ARK5 Inhibitor Program

Following signing of the collaboration agreement with HanX, Onconova initiated a pre-IND process with the U.S. Food and Drug Administration (FDA).

Presentations of Data

Rigosertib in MDS at the ASH (Free ASH Whitepaper) 2017 Meeting

Onconova delivered two poster presentations highlighting drug activity and the mechanism of action of rigosertib in MDS during the 59th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in Atlanta in December, 2017.

· Among the highlights of the presentation were: Oral rigosertib as a single agent demonstrated activity in a Phase 2 trial for lower-risk MDS; 32% of 62 evaluable patients, and 44% of patients receiving optimal dosing, achieved transfusion independence; and new data on the molecular basis of the combination therapy with rigosertib and azacitidine in epigenetic studies in patient derived stem cells.

Full Year 2017 Financial Results:

Cash and cash equivalents as of December 31, 2017, totaled $4.0 million, compared to $21.4 million as of December 31, 2016. Subsequently, on February 12, 2018, Onconova announced the closing of a $10 million underwritten public offering of 9,947,500 shares of common stock or common stock equivalents and warrants to purchase an aggregate of 994,750 shares of Onconova’s Series A convertible preferred stock, including the exercise in full of the underwriter’s option to purchase additional securities, at the public offering price of $1.01 per share and accompanying Preferred Stock Warrant. Onconova also issued to the underwriter a preferred stock warrant to purchase 49,737.5 shares of Series A convertible preferred stock. Based on the Company’s cash burn for 2017 and its current projections, Onconova expects that cash and cash equivalents will be sufficient to fund ongoing trials and operations into the third quarter of 2018.

Net loss was $24.1 million for the year ended December 31, 2017, compared to $19.7 million for the year ended December 31, 2016, primarily due to the lack of collaboration cost sharing revenue in the 2017 period and a smaller change in fair value of warrant liability in the 2017 period.

Research and development expenses were $19.1 million for the year ended December 31, 2017, and $20.1 million for the comparable period in 2016.

General and administrative expenses were $7.4 million for the year ended December 31, 2017, and $9.2 million for comparable period in 2016.

The Company will host a conference call on March 8th at 9:00 a.m. Eastern Time to provide a corporate update and discuss fourth quarter and full-year financial results. Interested parties may access the call by dialing toll-free (855) 428-5741 from the US, or (210) 229-8823 internationally and using conference ID: 2947108.

The call will also be webcast live. Please click here to access the webcast.

A replay will be available at this link until June 29, 2018