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.

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

On March 8, 2018 Jounce Therapeutics, Inc. (NASDAQ:JNCE), a clinical stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers for patient enrichment, today reported financial results and provided a corporate update for the quarter and year ended December 31, 2017 (Press release, Jounce Therapeutics, MAR 8, 2018, View Source;p=RssLanding&cat=news&id=2336966 [SID1234524971]).

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"2017 was an important year of execution for Jounce, and our first year as a publicly-traded company. Our corporate progress this past year started with our initial public offering in January 2017 and expanded to the growth of our team and Board as well as our capabilities to support our broader pipeline mission. On the clinical front, we executed on the development of our lead program, JTX-2011, achieving several milestones," said Richard Murray, Ph.D., chief executive officer and president of Jounce Therapeutics. "We continue to make progress towards realizing our vision of transforming the treatment of cancer by delivering first-in-class immunotherapies that provide long-lasting benefits. With this tenet guiding our long-term growth, our goal is to leverage the great progress we have made to date and execute on our key value drivers for 2018."

Clinical and Research Highlights:

Phase 1/2 ICONIC Trial

The Phase 1/2 ICONIC trial remains on track and preliminary efficacy data are expected to be reported in the second quarter of 2018.
Two of the Phase 2 combination cohorts in the ICONIC trial, gastric cancer and triple negative breast cancer (TNBC), have met the target enrollment with completion of at least one efficacy assessment. The preliminary efficacy data have been submitted as an abstract for the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The abstract includes both monotherapy and combination preliminary efficacy data from these two tumor types. These data are expected to mature between the abstract submission date and the ASCO (Free ASCO Whitepaper) meeting, and therefore the Company expects to provide data on additional patients, longer-term follow-up, and additional biomarker information.
In 2018, the JTX-2011 program is expected to expand by initiating a new combination study within the adaptive ICONIC trial. While continuing to evaluate combination cohorts with a PD-1 inhibitor, a new combination is expected to begin with JTX-2011 and a CTLA-4 inhibitor. The Company believes that the inducible nature of ICOS, or Inducible T cell CO-Stimulator, will be a potential cornerstone of Jounce’s strategy in combination trials. By combining with other approved therapies, JTX-2011 may potentially maximize the benefit of immunotherapeutic approaches across a broad spectrum of indications.
JTX-4014

Jounce remains on track to file an Investigational New Drug, or IND, in 2018 for JTX-4014, its internal anti-PD-1 antibody. The Company views JTX-4014 as an important component of its pipeline given its belief that combination therapy will be a mainstay of cancer immunotherapy.
Next Development Candidate

Jounce continues to focus on its discovery programs both within and outside of its Celgene collaboration. The first tumor associated macrophage candidate, coming from Jounce’s Translational Science Platform, has advanced into IND-enabling activities. Therapies targeting these innate immune cells may potentially complement existing T cells-focused approaches, thereby providing benefit to patients with less inflamed or colder tumors.
Corporate Highlights:

In December 2017, Jounce was added to the NASDAQ Biotechnology Index as a result of meeting the eligibility requirements, including minimum market capitalization and average daily trading volume, among other criteria.
Fourth Quarter and Full Year 2017 Financial Results:

Cash Position: As of December 31, 2017, cash, cash equivalents and investments were $257.9 million, compared to $257.4 million as of December 31, 2016. This increase was primarily due to the $106.4 million in net proceeds from Jounce’s initial public offering (IPO), offset by operating costs during the year. Overall, Jounce utilized $105.9 million in net cash for the full year 2017.
Collaboration Revenue: Collaboration revenue was $13.0 million for the fourth quarter of 2017, compared to $20.3 million for the same period in 2016 and $71.6 million for the full year 2017, compared to $37.2 million for the same period in 2016. Collaboration revenue represents the revenue recognition relating to the $225.0 million upfront payment received in July 2016 upon the execution of Jounce’s global strategic collaboration with Celgene.
Research and Development (R&D) Expenses: R&D expenses were $18.6 million for the fourth quarter of 2017, compared to $10.7 million for the same period in 2016 and $67.8 million for the full year 2017, compared to $34.9 million for the same period in 2016. The increase in R&D expenses for both the fourth quarter of 2017 and the full year 2017 was due to increased employee compensation costs related to increased headcount, clinical costs related to the Phase 1/2 ICONIC trial of JTX-2011 and external research and development costs, primarily attributable to the manufacture of clinical trial materials and related activities.
General and Administrative (G&A) Expenses: G&A expenses were $6.0 million for the fourth quarter of 2017, compared to $4.7 million for the same period in 2016 and $23.1 million for the full year 2017, compared to $16.8 million for the same period in 2016. The increase in G&A expenses for both the fourth quarter of 2017 and the full year 2017 was primarily due to increased employee compensation costs related to increased headcount, facilities costs and other costs attributable to operating as a public company. In addition, the increase in G&A expenses for the full year 2017 was offset by $2.0 million of legal and accounting costs written off during 2016 as a result of the postponement of the IPO. The IPO was originally postponed for a period significantly in excess of 90 days, and as a result, the previously-capitalized costs were written off to G&A expenses.
Net (Loss) Income: Net loss was $9.4 million for the fourth quarter of 2017, or a basic and diluted net loss per share attributable to common stockholders of $0.29. Net income was $5.5 million for the same period in 2016, or basic net income per share attributable to common stockholders of $0.11 and diluted net income per share attributable to common stockholders of $0.05. The change is primarily attributable to operating income recognized for the fourth quarter of 2016 as compared to an operating loss incurred for the fourth quarter of 2017. Net loss was $16.4 million for the full year 2017, or a basic and diluted net loss per share attributable to common stockholders of $0.57 compared to $13.7 million for same period in 2016, or a basic and diluted net loss per share attributable to common stockholders of $11.00. The decrease in net loss per share attributable to common stockholders is primarily due to an increase in shares of common stock outstanding post-IPO.
Financial Guidance:

Based on its current plans, Jounce expects cash burn on operating expenses and capital expenditures for the full year 2018 to be approximately $80.0 million to $100.0 million. The Company expects to record approximately $50.0 million to $60.0 million in collaboration revenue in 2018 from the continued recognition of the Celgene upfront payment received in 2016.

Given the strength of its balance sheet, Jounce continues to expect its existing cash, cash equivalents and investments to be sufficient to enable the funding of its operating expenses and capital expenditure requirements for at least the next 24 months.

Conference Call and Webcast Information:

Jounce Therapeutics will host a live conference call and webcast today at 8:00 a.m. ET. To access the conference call, please dial (866) 916-3380 (domestic) or (210) 874-7772 (international) and refer to conference ID 6198947. The live webcast can be accessed under "Events & Presentations" in the Investors and Media section of the company’s website at www.jouncetx.com. The webcast will be archived and made available for replay on the company’s website approximately two hours after the call and will be available for 30 days.

Cautionary Note Regarding Forward-Looking Statements:

Various statements in this release concerning Jounce’s future expectations, plans and prospects, including without limitation, Jounce’s expectations regarding operating expenses, capital expenditures, collaboration revenue and other financial results, release of data from the Phase 1/2 ICONIC trial, expansion of the JTX-2011 program, the filing of an IND for JTX-4014 and the timing, progress and results of preclinical studies and clinical trials for Jounce’s product candidates and any future product candidates may constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws and are subject to substantial risks, uncertainties and assumptions. You should not place reliance on these forward looking statements, which often include words such as "anticipate," "believe," "estimate," "expect," "intend," "may," "on track," "plan," "predict," "target," "potential" or similar terms, variations of such terms or the negative of those terms. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, the Company cannot guarantee such outcomes. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, Jounce’s ability to successfully demonstrate the efficacy and safety of its product candidates and future product candidates, the preclinical and clinical results for its product candidates, which may not support further development and marketing approval, the potential advantages of Jounce’s product candidates, the development plans of its product candidates, actions of regulatory agencies, which may affect the initiation, timing and progress of pre-clinical studies and clinical trials of its product candidates, Jounce’s ability to obtain, maintain and protect its intellectual property, Jounce’s ability to manage operating expenses, Jounce’s ability to maintain its collaboration with Celgene, as well as those risks more fully discussed in the section entitled "Risk Factors" in Jounce’s most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission as well as discussions of potential risks, uncertainties, and other important factors in Jounce’s subsequent filings with the Securities and Exchange Commission. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

On March 8, 2018 Dynavax Technologies Corporation (NASDAQ: DVAX) reported financial results for the fourth quarter and year ended December 31, 2017 (Press release, Dynavax Technologies, MAR 8, 2018, View Source [SID1234524559]). The net loss for the year ended December 31, 2017, was $95.2 million, or $1.81 per share, compared to $112.4 million, or $2.92 per share, for the year ended December 31, 2016.

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Recent Highlights

Received FDA approval of first and only two-dose hepatitis B vaccine, HEPLISAV-B [Hepatitis B Vaccine (Recombinant), Adjuvanted] for prevention of infection caused by all known subtypes of the virus in adults age 18 years and older

Launched HEPLISAV-B in the U.S. with a 60-person field sales team covering over 75% of the target market

HEPLISAV-B recommended by the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) for use in the vaccination of adults, which is a critical milestone to drive broad insurance coverage and adoption for HEPLISAV-B

$100 million received in initial tranche of $175 million non-dilutive term loan agreement to support commercial efforts and advance and expand immuno-oncology platform

"On the heels of HEPLISAV-B’s FDA approval, we entered 2018 positioned to achieve significant milestones and are excited about our accomplishments to date," said Eddie Gray, Chief Executive Officer of Dynavax. "We have strengthened our balance sheet with a non-dilutive financing, enabling us to focus on value creation for our shareholders through both our commercial and clinical development programs. Our commercial team has done an excellent job launching HEPLISAV-B and executing our strategy to ensure we build a solid foundation to drive sales as the year progresses. We are confident that the HEPLISAV-B two-dose in one month administration and the earlier and higher seroprotection rates demonstrated versus ENGERIX-B will make it the new standard of care."

"Equally exciting are the opportunities to generate significant additional value for Dynavax as we report clinical data from our immuno-oncology clinical trials. Data from the phase 2 studies of our lead oncology product candidate, SD-101, in combination with Merck’s anti-PD-1 therapy, KEYTRUDA, are expected to be presented at major oncology conferences in the first half of the year. We believe that data from these trials in head and neck cancer and melanoma will support the initiation of a Phase 3 study in the second half of the year. In parallel, we are pursuing additional opportunities to expand our TLR platform and will continue to provide updates on our progress."

The Company had $191.9 million in cash, cash equivalents and marketable securities at December 31, 2017 compared to $81.4 million at December 31, 2016. In addition, in the first quarter of 2018 the

Company closed on a $175 million term loan agreement and received $100 million in a first tranche funding. Up to an additional $75 million may be borrowed in a second tranche at the Company’s option.

Additional Financial Results

Research and development expenses for the quarter and year ended December 31, 2017, were $17.4 million and $65.0 million, respectively, compared to $18.4 million and $84.5 million for the same periods in 2016. The overall decrease in the 2017 periods reflects reduced compensation and related personnel costs as a result of the January 2017 restructuring and cost reduction initiative. Additionally, the 2017 period reflects lower costs related to HEPLISAV-B clinical and manufacturing activity partially offset by increased costs related to the FDA approval process for HEPLISAV-B and the ongoing development of SD-101, DV281 and earlier stage oncology programs. In the fourth quarter of 2017, we reinitiated manufacturing operations, and began hiring personnel and retaining vendors as we prepared for the commercial launch of HEPLISAV-B in January 2018.

Selling, general and administrative expenses for the quarter and year ended December 31, 2017, were $9.3 million and $27.4 million, respectively, compared to $8.2 million and $37.3 million for the same periods in 2016. The overall decrease in 2017 reflects reduced compensation and related personnel costs as described above. In the fourth quarter of 2017, we had expenses related to preparation for the commercial launch of HEPLISAV-B in January 2018. In 2016, expenses included costs related to hiring of consultants for administrative and commercial development services for an anticipated commercial launch of HEPLISAV-B which was delayed.

About Hepatitis B

Hepatitis B is a viral disease of the liver that can become chronic and lead to cirrhosis, liver cancer and death. The hepatitis B virus is 50 to 100 times more infectious than HIV,i and transmission is on the rise. Hepatitis B is a major public health issue in the United States, where an estimated 20,000 new infections occur each year, and approximately 850,000 people are currently living with this chronic disease.i In 2015, new cases of acute hepatitis B increased by more than 20 percent nationally.ii There is no cure for hepatitis B, but effective vaccination can prevent the disease.

In adults, hepatitis B is spread through contact with infected blood and through unprotected sex with an infected person. The CDC recommends that individuals at high risk for hepatitis B infection due to their jobs, lifestyle, living situations and travel to certain areas be immunized.iii Because people with diabetes are particularly vulnerable to infection, the CDC recommends vaccination for adults age 19 to 59 with diabetes as soon as possible after their diagnosis, and for people age 60 and older with diabetes at their physician’s discretion.iv Approximately 20 million U.S. adults have diabetes, and 1.5 million new cases of diabetes are diagnosed each year.v

About HEPLISAV-B

HEPLISAV-B is an adult hepatitis B vaccine that combines hepatitis B surface antigen with Dynavax’s proprietary Toll-like Receptor (TLR) 9 agonist to enhance the immune response. Dynavax has worldwide commercial rights to HEPLISAV-B.

Indication and Use

HEPLISAV-B is indicated for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.

Important Safety Information (ISI)

Do not administer HEPLISAV-B to individuals with a history of severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast.

Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of HEPLISAV-B.

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to HEPLISAV-B.

Hepatitis B has a long incubation period. HEPLISAV-B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration.

The most common patient reported adverse reactions reported within 7 days of vaccination were injection site pain (23% to 39%), fatigue (11% to 17%) and headache (8% to 17%).

For full Prescribing Information for HEPLISAV-B, click here.

About SD-101
SD-101, the Company’s lead clinical candidate, is a proprietary, second-generation, Toll-like receptor 9 (TLR9) agonist CpG-C class oligodeoxynucleotide. Dynavax is evaluating this intratumoral TLR9 agonist in several clinical studies to assess its safety and activity, including a Phase 2 study in combination with Keytruda (pembrolizumab), an anti-PD-1 therapy, in patients with metastatic melanoma and in patients with head and neck squamous cell cancer, in a clinical collaboration with Merck. Dynavax maintains all commercial rights to SD-101.

About DV281

DV281 is Dynavax’s proprietary investigational TLR9 agonist designed specifically for focused delivery to primary lung tumors and lung metastases. DV281 is similar in biological activity and mechanism of action to Dynavax’s Phase 2 immunotherapy candidate, SD-101, but has been optimized for administration as an aerosol. Both SD-101 and DV281 are designed to activate plasmacytoid dendritic cells and stimulate T cells specific for antigens released from dying tumor cells. TLR9 agonists such as DV281 and SD-101 have been shown to stimulate potent Type 1 interferon induction along with maturation of dendritic cells to effective antigen-presenting cells; both activities are important for the induction of effective anti-tumor immunity. Dynavax has initiated dosing in a phase 1B dose escalation clinical trial of DV281 in patients with non-small cell lung cancer.

For information about SD-101 and DV281 trials that are currently recruiting patients, please visit www.clinicaltrials.gov