Threshold Pharmaceuticals Reports Fourth Quarter and Full Year 2016 Financial Results

On March 27, 2017 Threshold Pharmaceuticals, Inc. (Nasdaq:THLD), a clinical-stage biopharmaceutical company developing novel therapies for cancer, reported financial results for the fourth quarter and full year ended December 31, 2016 and provided an update on the Company’s corporate and clinical development activities, including the proposed merger with Molecular Templates, Inc (Press release, Threshold Pharmaceuticals, MAR 27, 2017, View Source [SID1234518410]).

Threshold announced on March 17, 2017 that it had entered into a definitive agreement under which Molecular Templates will merge with a wholly owned subsidiary of Threshold in an all-stock transaction. The transaction will result in a combined company focused on the development of novel treatments for cancer. Longitude Capital, a U.S. based venture capital firm, will invest $20 million at the close of the transaction, subject to certain conditions, including the receipt of additional equity financing commitments of an additional $20 million.

Barry Selick, Ph.D., Chief Executive Officer of Threshold, said, "On behalf of the Company and the entire board of directors, I’d like to thank Threshold shareholders for their support while we conducted our extensive and thorough review of strategic alternatives, after very challenging clinical outcomes for evofosfamide and tarloxotinib." Dr. Selick further stated, "We believe Molecular Templates’ lead product candidate, MT-3724, and our lead product candidate, evofosfamide, in addition to Molecular Templates’ innovative technology platform will result in a combined company that has significant value for its stakeholders."

Recent Highlights
About the Proposed Merger
The transaction has been approved by the board of directors of both companies. The merger is expected to close in the second quarter of 2017, subject to the approval of the stockholders of each company as well as other customary conditions. Upon closing of the transaction, Threshold will change its name to Molecular Templates, Inc. and plans to change its ticker symbol on the Nasdaq Capital Market to MTEM. On a pro forma basis and based upon the number of shares of common stock to be issued in the merger, current Threshold shareholders would own approximately 34.4 percent of the combined company and current Molecular Templates shareholders would own approximately 65.6 percent of the combined company although the actual allocation will be subject to adjustment based on Threshold’s net cash balance.

Eric Poma, Ph.D., Chief Executive Officer of Molecular Templates, will become Chief Executive Officer of the combined company. Following the merger, the board of directors of the combined company will consist of seven seats and will be comprised of two representatives from Molecular Templates, two representatives from Threshold, and three representatives to be mutually agreed upon by Molecular Templates and Threshold. The Company’s current chairman of the board of directors, Barry Selick, Ph.D., will become chairman of the board of the combined company following the merger.

Evofosfamide
The Company’s lead product candidate is an investigational hypoxia-activated prodrug that is designed to be activated under tumor hypoxic conditions, a hallmark of many cancers. Recent updates include:

· Held first meeting with the Japanese PMDA (Pharmaceutical and Medical Devices Agency) to present the improvement in overall survival that was observed in the Japanese sub-population of the MAESTRO Phase 3 trial. While the PMDA indicated that the current analysis of the MAESTRO data is not sufficient to support the submission of a New Drug Application ("NDA") in Japan, the Company is in ongoing discussions with the PMDA to clarify the scope of an additional study, the results of which may then support the submission of an NDA for evofosfamide in Japan.

· Investigator-sponsored and cooperative group clinical trials investigating evofosfamide in patients with pancreatic neuroendocrine tumors (pNET), recurrent glioblastoma (GBM) and hepatocellular carcinoma (HCC) and advanced biliary tract cancer (BCT) remain ongoing

· In the second quarter, the Company plans to commence a Phase 1 clinical trial evaluating evofosfamide in combination with the immune checkpoint antibody, ipilumumab, at the M.D. Anderson Cancer Center in Houston Texas to potentially improve the efficacy of immune checkpoint antibody as an anti-cancer therapy.

TH-3424
TH-3424 is the Company’s small-molecule drug candidate being evaluated for the treatment of hepatocellular (liver) cancer (HCC), castrate resistant prostate cancer (CRPC), T-cell acute lymphoblastic leukemias (T-ALL), and other cancers expressing high levels of aldo-keto reductase family 1 member C3 (AKR1C3). Tumors overexpressing AKR1C3 can be resistant to radiation therapy, chemotherapy and anti-androgen therapy. TH-3424 is a prodrug that selectively releases a potent DNA cross-linking agent in the presence of AKR1C3. Recent updates include:

· Entered into a collaboration with the National Cancer Institute (NCI) to explore the effects of TH-3424 against T-ALL xenograft cell lines with high AKR1C3 expression. The studies will be conducted through the NCI-funded Pediatric Preclinical Testing Program (PPTp). Threshold will supply TH-3424, and the NCI will fund the studies that will be conducted at the PPTP leukemia research sites.

· Investigational New Drug (IND)-enabling studies of TH-3424 have been initiated in collaboration with Ascenta Pharmaceuticals, Ltd.

Fourth Quarter and Year End 2016 Financial Results
· As of December 31, 2016 and 2015, Threshold had $23.6 million and $48.7 million in cash, cash equivalents and marketable, respectively. The net decrease of $25.1 million was a result of operating cash requirements for the year ended December 31, 2016.

· No revenue was recognized in the fourth quarter and year ended December 31, 2016 compared to $65.9 million and $76.9 million for the same periods in 2015. Revenue for the quarter and year ended December 31, 2015 related to the amortization of the aggregate of $110 million in upfront and milestone payments received from the Company’s former collaboration with Merck KGaA, Darmstadt, Germany. The revenue from the upfront payment and milestone payments received under the agreement were previously being amortized over the relevant performance period, rather than being immediately recognized when the upfront payment and milestones were earned or received. As a result of Merck KGaA, Darmstadt, Germany’s and the Company’s decision to cease further joint development of evofosfamide in December 2015, the Company immediately recognized all of the remaining deferred revenue into revenue during the quarter ending December 31, 2015. Also as a result of the termination of the agreement, the Company is no longer eligible to receive any further milestone payments from Merck KGaA, Darmstadt, Germany.

· Research and development expenses were $3.0 million for the fourth quarter ended December 31, 2016, compared to $11.4 million for the same period in 2015. The $8.4 decrease in research and development expenses, net of reimbursement for Merck KGaA, Darmstadt, Germany’s 70 percent share of total eligible collaboration expenses for evofosfamide, was due primarily to a $4.6 million decrease in employee related expenses, including a $1.0 million decrease in non-cash stock-based compensation expense and a $3.8 million decrease in clinical development expenses and consulting expenses. Research and development expenses were $16.6 million for the year ended December 31, 2016, compared to $40.3 million for the same period in 2015. The $23.7 million decrease in research and development expenses, net of reimbursement for Merck KGaA, Darmstadt, Germany’s 70 percent share of total eligible collaboration expenses for evofosfamide, was due primarily to a $14.1 million decrease in employee related expenses, including a $2.8 million decrease in non-cash stock-based compensation expense, a $8.3 million decrease in clinical development expenses and a $1.3 million decrease in consulting expenses.

· General and administrative expenses were $2.0 million for the fourth quarter ended December 31, 2016 compared to $2.2 million for the same period in 2015. The decrease in general and administrative expenses was due primarily to a $0.2 million decrease in employee related expenses. General and administrative expenses were $7.8 million for the year ended December 31, 2016 compared to $9.7 million for the same period in 2015. The $1.9 million decrease in general and administrative expenses was due primarily to a $1.5 million decrease in employee related expenses and $0.4 million in consulting expenses.

· Non-cash stock-based compensation expense included in total operating expenses was $0.7 million and $3.1 million for the fourth quarter and year ended December 31, 2016, respectively, compared to $2.0 million and $6.8 million for the same periods in 2015, respectively. The decrease in stock-based compensation expense was due to the amortization of a smaller number of options with lower fair values.

· Net loss for the fourth quarter ended December 31, 2016 was $3.7 million compared to net income of $69.7 million for the same period in 2015. Included in the net loss for the fourth quarter of 2016 was an operating loss of $5.0 million and non-cash income of $1.2 million compared to an operating income of $52.3 million and non-cash income of $17.4 million for the fourth quarter of 2015. Net loss for the year ended December 31, 2016 was $24.1 million compared to net income of $43.8 million for the same period in 2015. Included in the net loss for 2016 was an operating loss of $24.3 million and non-cash income of $0.1 million compared to an operating income of $26.9 million and non-cash income of $16.8 million for the year ended December 31, 2015. The non-cash income is related to changes in the fair value of the Company’s outstanding warrants that was classified as other income (expense).

About Evofosfamide
Evofosfamide (previously known as TH-302) is an investigational hypoxia-activated prodrug of a bis-alkylating agent that is preferentially activated under severe hypoxic tumor conditions, a feature of many solid tumors. Areas of low oxygen levels (hypoxia) in solid tumors are due to insufficient blood vessel supply. Similarly, the bone marrow of patients with hematological malignancies has also been shown, in some cases, to be severely hypoxic.

About TH-3424
TH-3424 is small-molecule drug candidate being evaluated for the potential treatment of hepatocellular (liver) cancer (HCC), castrate resistant prostate cancer (CRPC), T-cell acute lymphoblastic leukemias (T-ALL), and other cancers expressing high levels of aldo-keto reductase family 1 member C3 (AKR1C3). Tumors overexpressing AKR1C3 can be resistant to radiation therapy and chemotherapy. TH-3424 is a prodrug that selectively releases a potent DNA cross-linking agent in the presence of AKR1C3. Preliminary nonclinical toxicology studies suggested an adequate therapeutic index that the Company believes warrants conducting Investigational New Drug (IND)-enabling toxicology studies, which are being done in collaboration with Ascenta Pharmaceuticals, Ltd.

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Sophiris Bio Reports Fourth Quarter and Full Year 2016 Financial Results and Key Corporate Highlights

On March 27, 2017 Sophiris Bio Inc. (NASDAQ: SPHS) (the "Company" or "Sophiris"), a clinical late-stage biopharmaceutical company developing topsalysin (PRX302) for the treatment of patients with urological diseases, reported fourth quarter and full year 2016 financial results and key corporate highlights (Press release, Sophiris Bio, MAR 27, 2017, View Source [SID1234518395]).

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Key Corporate Highlights:

Advanced Topsalysin (PRX302) in Clinical Development for Localized Prostate Cancer. During 2016, the Company reported successful results with topsalysin in a completed Phase 2a study for the focal treatment of localized prostate cancer. In 2017, the Company continued the development of topsalysin for the focal treatment of localized prostate cancer with the initiation of a Phase 2b clinical study.

Initiated Phase 2b Localized Prostate Cancer Study. In March 2017, the Company initiated its Phase 2b open-label localized prostate cancer study with investigational sites in both the UK and US. The primary objective of the study is safety and tolerability of an injection of topsalysin and the key efficacy variable is focal ablation of a clinically significant lesion on biopsy after six months. Approximately 40 patients with localized prostate cancer are expected to be enrolled in the study and patient screening has begun

Previously obtained multi-parametric magnetic resonance imaging (mpMRI) of tumor lesions in each patient’s prostate, mapped to real-time three dimensional ultrasound will be used in the study to guide an intrasprostatic injection of topsalysin to treat a single, histological-proven, clinically significant lesion area in each patient’s prostate.

Six months following treatment with topsalysin, a targeted biopsy of the treated area will be conducted. The Company expects to receive the six-month biopsy data for all patients in late 2017 or early 2018. Based upon the results of the 6-month biopsy, the study includes an option to potentially re-treat the targeted lesion area with a second dose of topsalysin, with a targeted biopsy to occur six months following the second dose. In order to be eligible for a second dose, the patient cannot have experienced a significant adverse event attributable to topsalysin or the dosing procedure from the first dose and the patient will need to have had a clinical response from the first dose but still have the presence of a clinically significant lesion area. The Company expects to have final biopsy data on all patients who receive a second dose by the third quarter of 2018.

Reported Successful Results from a Phase 2a Localized Prostate Cancer Study. In June 2016, the Company announced successful results from its completed Phase 2a study of topsalysin in the focal treatment of localized prostate cancer. Biopsy data at six months following treatment in 18 patients showed that topsalysin demonstrated the ability to ablate tumor cells in over half of the patients and two patients experienced complete ablation of their targeted tumor with no histological evidence of any tumor remaining at six months.

Reported Positive Data at Important Urological Meeting. The Company presented positive data from its Phase 3 clinical trial of topsalysin as a treatment for the symptoms of benign prostatic hyperplasia ("BPH") as a late breaking poster at the 111th American Urological Association Annual Meeting. A copy of the poster is available on the Company’s website at www.sophirisbio.com.

Improved Financial Profile to Support Topsalysin Clinical Plans. During 2016, the Company raised net proceeds of $27.4 million and $7.0 million through two financing transactions. As of December 31, 2016, the Company had cash, cash equivalents and securities available-for-sale of $29.0 million and working capital of $27.8 million. The Company expects that its cash, cash equivalents and securities available-for-sale will allow the Company to operate through the end of 2018.
"During 2016, Sophiris has made significant clinical development progress in advancing topsalysin, a novel and first-in-class targeted biologic," said Randall E. Woods, president and CEO of Sophiris. "We believe that topsalysin may be an effective treatment to address significant unmet medical needs in two major commercial markets. Topsalysin could potentially provide a new intermediate treatment that may delay or even obviate the need for more radical treatment approaches in both localized prostate cancer as well as BPH. Topsalysin also has the potential to maintain or improve a patient’s quality of life post-treatment while at the same time remaining attractive to payors."

Financial Results:

At December 31, 2016, the Company had cash, cash equivalents and securities available-for-sale of $29.0 million and working capital of $27.8 million. The Company expects that its cash and cash equivalents will be sufficient to fund its operations through the end of 2018. The Company is currently not planning on pursuing a second Phase 3 trial in BPH, unless the Company can secure a development partner to fund such new clinical trial or the Company obtains other financing.

For the three months ended December 31, 2016

The Company reported a net loss of $0.5 million ($0.02 per share) for the three months ended December 31, 2016 compared to a net loss of $2.5 million ($0.15 per share) for the three months ended December 31, 2015.

Research and development expenses were $1.0 million for the three months ended December 31, 2016, compared to $1.7 million for the three months ended December 31, 2015. The decrease in research and development expenses were primarily attributable to a decrease in the costs associated with the Company’s Phase 3 PLUS-1 clinical trial which was completed in November 2015 and its Phase 2a proof of concept clinical trial for localized prostate cancer which was completed in June 2016.

General and administrative expenses were $1.2 million for the three months ended December 31, 2016 compared to $0.7 million for the three months ended December 31, 2015. The increase in general and administrative expenses was primarily due to an increase in personnel related costs.

Gain on revaluation of the warrant liability was $1.6 million for the three months ended December 31, 2016. This non-cash gain was associated with the change in the fair value of the Company’s warrant liability from September 30, 2016 to December 31, 2016.

For the 12 months ended December 31, 2016

The Company reported a net loss of $11.2 million ($0.49 per share) for the twelve months ended December 31, 2016 compared to a net loss of $14.2 million ($0.84 per share) for the twelve months ended December 31, 2015.

Research and development expenses were $3.5 million for the twelve months ended December 31, 2016 compared to $9.9 million for the twelve months ended December 31, 2015. The decrease in research and development costs were primarily attributable to a decrease of $5.9 million in the costs associated with the Company’s completed Phase 3 PLUS-1 clinical trial of topsalysin for the treatment of BPH and to a lesser extent a decrease in costs associated with the Company’s Phase 2a proof of concept clinical trial for localized prostate cancer which commenced in May 2015 and was completed in June 2016.

General and administrative expenses were $6.8 million for the twelve months ended December 31, 2016 compared to $3.6 million for the twelve months ended December 31, 2015. The increase is primarily due to the inclusion of $1.6 million in offering costs which were allocated to the warrants issued in connection with the Company’s offerings which closed in May and August of 2016. The increase, to a lesser extent, is due to an increase in personnel related costs of $0.8 million and legal, accounting, consulting and professional fees of $0.7 million.

Loss on revaluation of the warrant liability was $0.3 million for the twelve months ended December 31, 2016. The non-cash loss was associated with the change in the fair value of the Company’s warrant liability.

Loss on early extinguishment of debt was $0.2 million for the twelve months ended December 31, 2016. This consists of the final payment and a prepayment fee which was offset by the Company’s unamortized debt premium resulting from the payoff of its loan with Oxford.

TESARO Announces U.S. FDA Approval of ZEJULA&#8482 (niraparib) for Women with Recurrent Ovarian Cancer

On March 27, 2017 TESARO, Inc. (NASDAQ: TSRO), an oncology-focused biopharmaceutical company, reported that the U.S. Food and Drug Administration (FDA) has approved ZEJULA (niraparib), an oral, once-daily poly(ADP-ribose) polymerase (PARP) inhibitor, for the maintenance treatment of women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response (CR or PR) to platinumbased chemotherapy (Press release, TESARO, MAR 27, 2017, View Source [SID1234518315]). ZEJULA is the first PARP inhibitor to be approved by the FDA that does not require BRCA mutation or other biomarker testing. TESARO anticipates launching ZEJULA in the United States in late April.

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Multimedia materials accompanying this release are available at: View Source

ZEJULA is the only PARP inhibitor that has demonstrated a clinically meaningful increase in progression-free survival (PFS) in women with recurrent ovarian cancer, regardless of BRCA mutation or biomarker status, in a randomized, prospectively designed Phase 3 clinical trial. ZEJULA offers oral, once-daily dosing, enabling convenient administration for maintenance treatment. FDA approval of ZEJULA is based upon data from the international Phase 3 ENGOTOV16/NOVA trial, a double-blind, placebo-controlled study that enrolled 553 patients with recurrent ovarian cancer who had achieved either a PR or CR to their most recent platinum-based chemotherapy. Approximately two-thirds of study participants did not have germline BRCA mutations. Progression in the NOVA study was determined by robust, unbiased, blinded central review, to be the earlier of radiographic or clinical progression. ZEJULA significantly increased PFS in patients with and without germline BRCA mutations as compared to control. Treatment with ZEJULA reduced the risk of disease progression or death by 74% in patients with germline BRCA mutations (HR 0.26) and by 55% in patients without germline BRCA mutations (HR 0.45). The magnitude of benefit was similar for patients entering the trial with a PR or a CR.

The most common grade 3/4 adverse reactions to ZEJULA in the NOVA trial included thrombocytopenia (29%), anemia (25%), neutropenia (20%), and hypertension (9%). The majority of hematologic adverse events were successfully managed via dose modification, and discontinuation of therapy due to thrombocytopenia, neutropenia and anemia occurred in 3.3%, 1.9% and 1.4% of patients, respectively. Following dose adjustment based on individual tolerability, the incidence of grade 3/4 thrombocytopenia was low; approximately

TyrNovo, a Kitov company, to Present Preclinical Data at the American Association for Cancer Research Annual Meeting

On March 28, 2016 Kitov Pharmaceuticals (NASDAQ and TASE: KTOV), reported that TyrNovo Ltd., a company majority-owned by Kitov, will present preclinical data on TyrNovo’s anti-tumor resistance drug candidate NT219 in a poster session at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2017, to be held April 1-5, at the Walter E. Washington Convention Center in Washington, D.C (Press release, Kitov Pharmaceuticals , MAR 27, 2017, View Source [SID1234518293]).

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Dr. Hadas Reuveni, TyrNovo’s founder and chief technology officer, will discuss recent promising results demonstrating NT219’s efficacy in patient-derived xenograft models (PDX) in mice.

NT219 is a small molecule that blocks two feedback pathways highly involved in drug resistance, IRS and STAT3. Combined treatment of NT219 with drugs targeting EGFR, such as Tagrisso and Erbitux, overcame acquired resistance of colon, lung, and head-and-neck cancers in PDX models.

Details on the poster presentations are as follows:

Title: Comprehensive high-throughput screen for combination therapies to block acquired resistance to targeted drugs

Session: PO.ET04.05 – Reversal of Drug Resistance

Location: Section 6

When: Monday, Apr 3, 2017, 8:00 AM – 12:00 PM ET

Poster Board Number: 1190 / 5

About TyrNovo

TyrNovo Ltd. is developer of novel small molecules in the oncology therapeutic field which is majority owned by Kitov Pharmaceuticals (NASDAQ/TASE: KTOV). TyrNovo is developing NT219, a potential oncology combination product. NT219 is a small molecule that presents a new concept in cancer therapy. In combination with various approved oncology drugs, NT219 demonstrated potent anti-tumor effects and increased survival in various cancer models, including sarcoma, melanoma, pancreatic, lung, ovarian, head & neck, prostate and colon cancers. Its mechanism of action is through the prevention of acquired resistance in tumors and by regression of resistant tumors. For more information on TyrNovo please visit View Source

Onconova Therapeutics, Inc. Reports Recent Business Highlights and Year-end 2016 Financial Results

On March 27, 2017 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, reported a corporate update and reported financial results for the year ended December 31, 2016 (Press release, Onconova, MAR 27, 2017, View Source [SID1234518287]).

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"We are pleased to report that our lead clinical candidate, rigosertib, is positioned for multiple key milestones, following the advancement of our late stage trials for patients with myelodysplastic syndromes (MDS). Enrollment for the targeted INSPIRE pivotal trial for patients with second-line higher-risk (HR) MDS is on track, with trial sites currently active across 17 countries on four continents. The trial eligibility criteria are highly selective and require extensive search to identify appropriate patients meeting the stringent entry criteria. We intend to maintain current momentum, with interim analysis expected in the second half of the year and full enrollment by the first quarter of 2018," said Dr. Ramesh Kumar, President and Chief Executive Officer.

"Development of oral rigosertib in combination with azacitidine for first line HR MDS patients is advancing as planned, with the protocol for a pivotal Phase 3 trial expected to be ready for submission to FDA for a Special Protocol Assessment during the second or third quarter of this year. MDS represents a growing and underserved market, with more than 10,000 patients diagnosed with HR-MDS annually in the U.S. No new therapy has been approved in over ten years and none has ever been approved for patients after the failure of hypomethylating agents."

"We will continue to focus on our lead programs and will look for partnering or other opportunities for our other pipeline and clinical programs. We will be presenting non-clinical data on pipeline compounds at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) conference," added Dr. Kumar.

Recent Business Highlights:

Enrollment on Track for INSPIRE Pivotal Trial of IV Rigosertib in 2nd line HR-MDS

The global Phase 3 INSPIRE trial of IV rigosertib in patients who have failed to respond to or progressed following hypomethylating agent (HMA) therapy is active in sites across four continents in 16 countries, which is in line with the Company’s plan. Our partner, SymBio Pharmaceuticals, has opened an additional 33 sites in Japan in collaboration on the INSPIRE protocol. The trial is expected to be active in all 19 countries in the second quarter of 2017 following the activation of sites in Switzerland and the Netherlands.
Pre-planned interim analysis for the global INSPIRE trial is currently on track and will be conducted after 88 death events have occurred.
Progress on Oral Rigosertib Combination with Azacitidine for 1st-line HR-MDS

Following a productive end of Phase 2 meeting with the Food and Drug Administration (FDA) in the third quarter of 2016, a protocol for a pivotal Phase 3 trial is being developed. The Company expects to submit this protocol for review by regulatory agencies in the US and Europe in the second or third quarter of 2017.
The pivotal trial will be designed as a 1:1 randomized placebo controlled trial of oral rigosertib plus azacitidine, compared to azacitidine plus placebo. The Company plans to use a full dose of azacitidine, as defined in the product insert. The patient population studied on this trial will be HMA naïve HR MDS patients. The primary endpoint for assessment of efficacy will be Response Rate of complete remission (CR) + partial remission (PR,) as per the International Working Group (IWG) 2006 Response criteria.
Formal FDA review will be sought via the Special Protocol Assessment (SPA) mechanism.
Further details, including sample size and other criteria will be available post regulatory review, anticipated in the second half of 2017. While the pivotal trial is being designed, we plan to expand the trial cohort with the view of further dose optimization for the planned pivotal Phase 3 Trial.
Upcoming Events and Conferences

Sachs Cancer Bio Partnering & Investor Forum, New York City: March 28, 2017
American Association for Cancer Research (AACR) (Free AACR Whitepaper), Washington, D.C.: April 1-5, 2017
2016 Financial Results

Cash and cash equivalents as of December 31, 2016, totaled $21.4 million, compared to $19.8 million as of December 31, 2015. Onconova believes that its current cash and cash equivalents will be sufficient to fund its ongoing trials and operations into the fourth quarter of 2017.
Net loss was $19.7 million for the year ended December 31, 2016, compared to $24.0 million for the year ended December 31, 2015, primarily due to the change in fair value of warrant liability in the 2016 period related to warrants issued in the July 2016 rights offering.
Research and development expenses were $20.1 million for the year ended December 31, 2016, compared to $25.9 million for the year ended December 31, 2015.
General and administrative expenses were $9.2 million for the year ended December 31, 2016, compared to $9.5 million for the year ended December 31, 2015.
"During 2016, we sharpened our focus and were able to reduce costs while making progress on our lead programs. We are encouraged with the interest from potential partners and importantly, look forward to advancing our clinical programs," concluded Dr. Kumar.