On May 15, 2017 Moleculin Biotech, Inc. (NASDAQ: MBRX) ("Moleculin" or the "Company"), a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center ("MD Anderson"), reported its financial and operating results for the first quarter ended March 31, 2017 and other recent developments (Press release, Advaxis, MAY 15, 2017, View Source [SID1234519112]).

First Quarter & Recent Highlights
Annamycin
Appointed Theradex Systems, Inc. as its contract research organization ("CRO") for its planned Phase I/II clinical trial for Annamycin for the treatment of relapsed or refractory acute myeloid leukemia ("AML").
Received Orphan Drug Designation by the U.S. Food and Drug Administration ("FDA") for the treatment of AML. The FDA grants orphan drug designation to drugs and biologics that are intended for the treatment of rare diseases that affect fewer than 200,000 people in the U.S. Orphan drug status is intended to facilitate drug development for rare diseases and may provide several benefits to drug developers, including tax credits for qualified clinical trial costs, exemptions from certain FDA application fees, and seven years of market exclusivity upon regulatory product approval.
Recently filed the IND application for Annamycin, with a Phase I/II approach with the intent of increasing the Maximum Tolerable Dose ("MTD"). In subsequent discussions, the FDA requested certain revisions to the protocol, additional information, and additional data related to Chemistry, Manufacturing and Controls ("CMC"). The Company has the additional information, has made the requested revisions to the protocol, and is working on developing the CMC data. In the interim, Moleculin has withdrawn the IND application in order to resubmit it when the requested data are available. The Company believes that the resubmission of the IND application will occur in time for the IND to go into effect prior to the end of July 2017 and allow for clinical trials. However, if the Company is unable to obtain the required CMC data on a timely basis, it will be delayed in resubmitting its IND application, which will delay the commencement of the clinical trials for Annamycin beyond July 2017.
Updated the Annamycin clinical strategy to add a Phase I arm to its next Phase II trial that leverages a potential increase in the MTD, which could increase the chance for positive outcomes. The Company believes that it will be able to publicly announce results from its Phase I/II clinical trial sometime in 2018.
WP1066
An MD Anderson physician is sponsoring a study of WP1066 for the treatment of brain tumors. While the Company is not participating in and has no influence on the conduct of this study, we understand that the sponsoring physician has submitted an IND to the FDA and the IND is on hold until documentation of Good Manufacturing Process or GMP production of WP1066 can be presented to the FDA, which Moleculin has agreed to provide. The Company expects that the sponsor’s IND will move forward in 2017 and may produce publishable clinical results in 2018.
Physician-scientists at another major US cancer center have requested and Moleculin has agreed to supply them with WP1066 for testing in a potential grant-funded clinical trial for children with Diffuse Intrinsic Pontine Gliomas (DIPG), a rare and very aggressive form of brain tumor. Studies conducted at this center have suggested that DIPG may be particularly sensitive to the inhibition of the activated form of a cell-signaling protein called STAT3, a primary target of WP1066, and their studies have demonstrated significant anti-tumor activity of WP1066 in DIPG in vitro and in vivo tumor models.
Corporate
Announced the closing of an underwritten public offering of securities for net proceeds of approximately $4.5 million. Roth Capital Partners and National Securities Corporation acted as joint book-running managers. Subsequently, approximately $0.8 million of additional funds have been received through the exercise of associated warrants issued in the offering bringing the total net raised in excess of $5 million.
Announced that Drs. Sandra Silberman and Paul Waymack have joined the Company’s Scientific Advisory Board ("SAB"). The Company’s current SAB also includes Dr. Waldemar Priebe (Chair) and Dr. Madeleine Duvic.
Planned Activities and Upcoming Potential Milestones
Anticipated Milestone Potential Timeframe
Announcement that our IND for Annamycin has become effective and that we may begin clinical trials End of July 2017
IRB (Institutional Review Board) approvals and site initiations of various clinical sites participating in our Phase I/II clinical trial of Annamycin Second Half of 2017
Establishment of a new MTD for Annamycin Second Half of 2017
A clinician sponsored IND for WP1066 for treatment of adult brain tumors moving forward Second Half of 2017
Announcement of Phase II data for Annamycin 2018
Announcement of further benefits of our sponsored research agreement with MD Anderson 2018
Walter Klemp, Chairman and CEO of Moleculin, stated: "We remain focused on developing the CMC data needed to submit our IND to move forward with the FDA by the end of July and to allow for clinical trials to begin. Additionally, we are pleased to have Theradex Systems as our CRO for our planned Phase I/II clinical trial for Annamycin. As we transition from a preclinical to a clinical stage company, we will continue to provide updates on our upcoming key milestones. We believe we have sufficient funds to pursue our planned operations into the first quarter of 2018."
Unaudited Financial Results for the Quarter Ended March 31, 2017
Research and development (R&D) expense was $0.68 million and $0.02 million for the three months ended March 31, 2017 and 2016, respectively. The increase of approximately $0.66 million is mainly due to the Company becoming fully operational post its June 1, 2016 Initial Public Offering ("IPO"). The difference mainly consists of increases of $0.15 million in sponsored research and research consultants, $0.13 million in employee related costs, $0.14 million in manufacturing and stability costs associated with the Company’s IND application, $0.1 million in regulatory counsel, $0.07 million in costs associated with the Company’s licenses, and $0.07 million of other costs. This increased activity represents the Company’s efforts in obtaining Orphan Drug designation for Annamycin and its associated IND application with the FDA.
General and administrative ("G&A") expense was $0.85 million and $0.31 million for the three months ended March 31, 2017 and 2016, respectively. The expense increase of approximately $0.54 million is mainly due to the Company becoming fully operational post its June 1, 2016 IPO. Specifically, these increases were attributable to $0.25 million associated with added headcount and associated payroll costs, $0.23 million in legal, auditing, and accounting costs, and $0.06 million in other G&A costs.
The Company recorded a gain of $1.06 million in the first quarter of 2017 for the change in fair value on revaluation of its warrant liability associated with the warrants issued in conjunction with its stock offering on February 14, 2017. The Company is required to revalue certain of its 2017 warrants at the end of each reporting period and reflect in the statement of operations a gain or loss from the change in fair value of the warrant in the period in which the change occurred. A gain results principally from a decline in the Company’s share price during the period and a loss results principally from an increase in the Company’s share price.
During the period, the Company settled a previously incurred expense utilizing shares of its common stock with an attributed value of $3.00 per share. The gain of $0.15 million reflects the difference in the Company’s share price in the open market as of the settlement date and $3.00 per share.
Interest expense includes expense accrued on convertible promissory notes issued in 2015 and 2016 bearing interest at the rate of 8% per annum.
The net loss for the three months ended March 31, 2017 was $0.33 million, which included the non-cash gains mentioned above aggregating to $1.21 million. Excluding this amount, the net loss for the period was $1.54 million, which is an increase of $1.21 million over the previous years’ $0.33 million net loss. Included in both net loss numbers for the three months presented was $0.11 million and $0.00 million for the 2017 and 2016, respectively, in stock based compensation.
As of March 31, 2017, the Company had $8.88 million of cash and cash equivalents compared to $5.00 million at December 31, 2016. In February 2017, Moleculin completed a public offering of its common stock and warrants, pursuant to which it received approximately $4.5 million in net proceeds, after deducting underwriting discounts and commissions and estimated offering expenses. Additionally, during the three months ended March 31, 2017, $0.80 million in cash was received due to warrants being exercised. Cash used in operations was $1.39 million for the first quarter of 2017. The Company believes that its existing cash and cash equivalents as of March 31, 2017 continues to be sufficient to fund planned operations into the first quarter of 2018.

On May 15, 2017 Vical Incorporated (Nasdaq:VICL) reported financial results for the three months ended March 31, 2017 (Press release, Vical, MAY 15, 2017, View Source [SID1234519128]). Net loss for the first quarter of 2017 was $2.8 million, or $0.25 per share, compared with a net loss of $2.4 million, or $0.26 per share, for the first quarter of 2016. Revenues for the first quarter of 2017 were $3.2 million, compared with revenues of $4.6 million for the first quarter of 2016, reflecting revenues from Astellas Pharma Inc. for manufacturing services performed under our ASP0113 collaborative agreements.

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Vical had cash and investments of $39.2 million at March 31, 2017. The Company’s net cash burn for the first quarter of 2017 was $1.8 million, which was consistent with the Company’s full year guidance of between $8 million and $11 million.

Program updates include:

ASP0113 CMV Therapeutic Vaccine

The multinational Phase 3 registration trial in HCT recipients completed enrollment in September 2016 with a total of 515 subjects. Dosing in the trial was completed in April 2017 and the follow-up period is expected to be finished in September 2017. The primary endpoint of the trial is a composite of overall mortality and CMV end organ disease which will be assessed one year after transplantation. Astellas expects top-line data to be available in the first quarter of 2018. Vical and Astellas continue to make progress towards a potential BLA filing in 2018.
VCL-HB01 HSV-2 Therapeutic Vaccine

Recruitment into the Phase 2 trial of the VCL-HB01 HSV-2 therapeutic vaccine has been completed with a total of 261 subjects enrolled at 15 U.S. clinical sites. VCL-HB01 is formulated with Vaxfectin and encodes two full-length HSV-2 antigens gD and UL46, and is designed to reduce recurrences in patients with symptomatic genital HSV-2 infection. Healthy adult subjects, 18 to 50 years of age, have been randomized 2:1 to receive either vaccine or placebo to evaluate the efficacy and safety of the vaccine. The primary endpoint of the study is annualized lesion recurrence rate which is a clinically meaningful endpoint for both patients and treating physicians as it provides important information on the number of recurrences over time in this chronic disease setting. Vical expects to deliver top-line results during the second quarter of 2018.
VL-2397 Antifungal

The VL-2397 development program will be featured in four poster presentations and an oral presentation at the June ASM Microbe meeting in New Orleans.
Vical has completed its first-in-human Phase 1 trial of its novel antifungal, VL-2397. The randomized, double-blind, placebo-controlled trial was designed to evaluate safety, tolerability and pharmacokinetics of single and multiple ascending doses of intravenous VL-2397 in 96 healthy volunteers. Results point to a favorable safety and pharmacokinetic profile for VL-2397. The data will be highlighted in one of the four poster presentations at ASM Microbe.
Vical plans to conduct a Phase 2 efficacy study to evaluate VL-2397 for the treatment of invasive aspergillosis and is working with clinical experts and the FDA towards this objective. The FDA has granted Vical Qualified Infectious Disease Product (QIDP), Orphan Drug and Fast Track designations to VL-2397 for the treatment of invasive aspergillosis. Under the QIDP designation Vical has been able to interact intensively with the FDA on the design of the Phase 2 trial and in exploring an expedited development pathway for VL‑2397.
Invasive aspergillosis represents a major unmet medical need given the high mortality rate in immunocompromised patients, despite availability of current antifungal therapies.
Vical will conduct a conference call and webcast today, May 15, at noon Eastern Time, to discuss the Company’s financial results and program updates with invited participants. The call and webcast are open on a listen-only basis to any interested parties. To listen to the conference call, dial in approximately ten minutes before the scheduled call to (719)325-2361 (preferred), or (888)466-4462 (toll-free), and reference confirmation code 9047479. A replay of the call will be available for 48 hours beginning about two hours after the call. To listen to the replay, dial (719)457-0820 (preferred) or (888)203-1112 (toll-free) and enter replay passcode 9047479. The call will also be available live and archived through the events page at www.vical.com. For further information, contact Vical’s Investor Relations department by phone at (858)646-1127 or by e-mail at [email protected].

On May 15, 2017 Sophiris Bio Inc. (NASDAQ: SPHS) (the "Company" or "Sophiris"), a late-stage clinical biopharmaceutical company developing topsalysin (PRX302) as a first-in-class treatment for urological diseases, reported that successful data from its Phase 2a proof-of-concept study of topsalysin, which evaluated the drug as a focal treatment for localized prostate cancer, will be presented today as a poster at the 112th AUA meeting (Press release, Sophiris Bio, MAY 15, 2017, View Source [SID1234519127]).

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Abstract Title: "Intra-Prostatic Injection of PRX302 Focal Therapy in Treating Clinically Significant Low-Intermediate Risk Prostate Cancer: An Open Label, Proof-of-Concept Study"
Presenting Author: Edward J. Bass, University College London, London, UK
Poster Session: MP70: Prostate Cancer: Localized: Ablative Therapy 1
Time: May 15, 2017 from 7:00 a.m. – 9:00 a.m. ET

The poster will be available on the Company’s website at www.sophirisbio.com.

On May 15, 2017 Cleveland BioLabs, Inc. (NASDAQ:CBLI) reported financial results and development progress for the first quarter ended March 31, 2017 (Press release, Cleveland BioLabs, MAY 15, 2017, View Source [SID1234519125]).

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Cleveland BioLabs reported a net loss of $(1.7) million, excluding minority interests, for the first quarter of 2017, or $(0.15) per share, compared to a net loss, excluding minority interests, of $(0.7) million, or $(0.06) per share, for the same period in 2016. The increase in net loss was primarily due to an increase in the non-cash adjustment to our warrant liabilities and decreased revenues and expenses due to the completion of our development contracts with the Russian Federation Ministry of Industry and Trade ("MPT"), which was partially offset by reduced operating costs aligned with our streamlined focus primarily on pursuing a pre Emergency Use Authorization ("pre-EUA") with the U.S. Food and Drug Administration ("FDA") and a Marketing Authorization Application ("MAA") with the European Medicines Agency ("EMA") for entolimod as a medical radiation countermeasure.

As of March 31, 2017, the Company had $13.1 million in cash, cash equivalents and short-term investments, which, based on the Company’s current operational plan, is estimated to fund operations for at least one year beyond the filing date of our Form 10-Q.

Yakov Kogan, Ph.D., MBA, Chief Executive Officer, stated, "The pursuit of commercialization for entolimod as a medical radiation countermeasure remains our top priority. As previously announced, we are excited to have received agreement from the FDA to commence the in vivo biocomparability study in non-human primates. Following completion of this study and discussion of the study results with the FDA, we expect the agency to resume the review of our pre-EUA dossier."

"We are also excited to have received a positive opinion from EMA on our pediatric investigational plan and are diligently working on assembling our MAA for submission to EMA," added Dr. Kogan.


Other Operational Highlights

• Entolimod Oncology Indications. We have completed dosing of 40 patients in a clinical study of the safety and tolerability of entolimod as a neo-adjuvant therapy in treatment-naïve patients with primary colorectal cancer who are recommended for surgery. This study was conducted in Russia and partially funded by the development contract with the MPT. The goal is to accumulate additional clinical data regarding immune cell response to administrations of entolimod to guide future oncology development. The analysis of the data is ongoing.

• CBLB612 is a synthetic molecule that activates the Toll-like heterodimeric receptor 2/6 and stimulated white blood cell generation in preclinical studies. Recently we have completed dosing in a Phase 2, randomized, placebo-controlled clinical study of CBLB612 as myelosuppressive prophylaxis in patients with breast cancer receiving doxorubicin-cyclophosphamide chemotherapy and data analysis of this study is in progress.

• Mobilan is a recombinant non-replicating adenovirus that directs expression of TLR5 and its agonistic ligand, a secretory non-glycosylated version of entolimod we are also developing through our subsidiary, Panacela Labs, Inc. Two randomized, placebo-controlled, dose-ranging studies of Mobilan in men with prostate cancer are currently ongoing in the Russian Federation.


Further Financial Results

Revenue for the first quarter of 2017 decreased to $0.6 million compared to $0.8 million for the first quarter of 2016. The net decrease was primarily attributable to reduced revenue from our development contracts with MPT which completed in 2016. This decrease was partially offset by increased revenue from our Joint Warfighter Medical Research Program ("JWMRP") contract from the Department of Defense ("DoD") for the continued development of the entolimod as a medical radiation countermeasure.

Research and development costs for the first quarter of 2017 decreased to $1.4 million compared to $1.9 million for the first quarter of 2016. The reduction in research and development costs is due to completion of our development contract with MPT and was offset, in part, by continued preclinical development along with other drug manufacturing activities associated with our JWMRP contract.

General and administrative costs for the first quarter of 2017 decreased to $0.8 million compared to $1.2 million for the first quarter of 2016. This decrease was primarily attributable to reductions in personnel and other operating costs in connection with cost savings efforts to streamline operations.

On May 15, 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 first quarter ended March 31, 2017 (Press release, Onconova, MAY 15, 2017, View Source [SID1234519123]).

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"We had a productive start to 2017, advancing the Phase 3 trial for our lead clinical candidate and securing funding to support ongoing clinical stage trials for patients with Myelodysplastic Syndromes (MDS). The presentation of positive data on two preclinical candidates representing potentially novel approaches for the treatment of Solid Tumors and Acute Myeloid Leukemia, Multiple Myeloma, and Lymphoma has resulted in increased interest from partners, and underscores the depth of our pipeline," said Dr. Ramesh Kumar, President and Chief Executive Officer.

"The INSPIRE Phase 3 trial for our lead clinical candidate, rigosertib, for the second-line treatment of patients with higher-risk (HR) MDS continues to advance as planned, with interim analysis and key enrollment milestones ahead. While we design our global Phase 3 trial of oral rigosertib in combination with azacitidine for first line HR MDS patients, we are expanding our Phase 2 combination trial to obtain additional efficacy and tolerability data across a larger number of trial sites. We plan to seek a Special Protocol Assessment in the United States after first obtaining Scientific Advice from the European regulatory authorities during the third quarter of this year. Thus, we are well-positioned for multiple key milestones as we seek to address the underserved needs of patients with MDS."

Enrollment Progressing for INSPIRE Trial of IV Rigosertib in 2nd Line HR-MDS

INSPIRE Trial Update

• 172 trial sites selected globally

18 countries with regulatory and IRB/ethics approvals
Australia, Austria, Belgium, Canada, Croatia, Czech Republic, France, Germany, Ireland, Israel, Italy, Japan, Netherlands, Poland, Spain, Sweden, UK & USA
Sites expected to initiate in May or June in Switzerland
Clinical trial applications are underway for 3 countries (Estonia, Hungry and Russia)
163 sites opened to date (44 North America, 86 ROW, 33 Japan)
• As of April 30, 60 sites in 14 countries have enrolled patients

First patients in Belgium, Ireland, Israel and Italy were enrolled in March or April
INSPIRE Trial Statistical Analysis Plan (SAP)

The SAP will provide clarity to the upcoming interim analysis as well as the top-line analysis of the INSPIRE trial. This document is currently under review by the Food and Drug Administration (FDA) and European Medicines Agency (EMA). We expect a response in Q2-2017.
Second Data Monitoring Committee (DMC) Review Completed

In this pre-planned safety analysis of data from enrolled patients in the INSPIRE trial, the DMC recommended that the study continue as planned.
Progress on Oral Rigosertib in Combination with Azacitidine for 1st-line HR-MDS

Phase 3 Trial Protocol

A synopsis of this Phase 3 trial has been completed and a briefing book has been submitted to the EMA for Scientific Advice.
A protocol for a Phase 3 trial for first-line patients with HR-MDS is being designed according to the trial parameters discussed during the end of Phase 2 meeting with the FDA in late 2016.
The Company expects to submit the protocol to the FDA for a Special Protocol Assessment during the third quarter of this year.
Expansion of Phase 2 Trial of Oral Rigosertib in Combination with Azacitidine

The two key objectives of this study are to obtain additional data on efficacy and tolerability of the combination regimen by continuing dose exploration and Quality of Life assessment in the new cohorts.
We anticipate opening more than 10 sites in this extension of the Phase 2 trial, including all three sites that participated in the original study. We plan to enroll up to 40 new patients in this study.
The first two patients have been enrolled in this expansion study.
Recent Data Presentation

The Company presented clinical data at the 14th International Symposium on Myelodysplastic Syndromes taking place May 3-6th in Valencia, Spain, with the Company’s collaborators from the Mount Sinai School of Medicine and the Cleveland Clinic.
The oral presentation of data from the Phase 2 combination trial highlighted the duration of response in patients with Complete Remission and presented a case study of a hypomethylating agent (HMA) refractory patient who had responded positively to the combination therapy for more than two years. In a poster presentation, a new prognostic tool being developed at the Cleveland Clinic was applied to conduct a retrospective analysis of ONTIME trial data to highlight the heterogeneity of the enrolled patients. The INSPIRE trial eligibility is designed to permit enrollment of a more homogeneous patient population.
Rare Disease Program in "Rasopathies"

Based on new mechanism of action data published last year, Onconova is initiating a collaborative development program focusing on a group of rare diseases with a well-defined molecular basis in defects in the Ras Effector Pathways.
The Company is developing preclinical and clinical collaborative programs with the National Institutes of Health (NIH)/ National Cancer Institute (NCI), academic investigators and Patient Advocacy Groups.
The NIH/NCI scientists have developed a broad ranging protocol for pediatric rasopathies. Onconova expects to execute a cooperative research and development agreement with the NIH/NCI for a clinical trial with rigosertib in these indications.
Another therapeutic focus will be Juvenile Myelomonocytic Leukemia, a well-described rasopathy affecting children, which is incurable without an allogenic hematopoietic stem cell transplant.
Further details of this program will be presented in a Key Opinion Leader session expected to be held during Q3-2017.
Proprietary Preclinical New Chemical Entities show Positive Results

Positive preclinical data was announced at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting, for ON 123300, a first-in-class dual inhibitor of CDK4/6 + ARK5, and for ON 150030, a novel Type 1 inhibitor of FLT3 and Src pathways. The meeting took place April 1-5 in Washington, DC.
In a preclinical Rb+ve xenograft model for breast cancer, ON 123300 activity was shown to be similar to Palbociclib (Pfizer’s Ibrance). Moreover, based on the same preclinical model, the new molecule may have the potential advantage of reduced neutropenia when compared to Palbociclib. Whereas both compounds resulted in decreased RBC and platelet counts in this preclinical model system, Palbociclib was found to have a more prominent and statistically significant (P< 0.05) inhibitory effect on neutrophil counts when compared to ON 123300. A full copy of the above AACR (Free AACR Whitepaper) poster can be accessed here.
Preclinical studies at the Icahn School of Medicine at Mount Sinai revealed that ON 150030 inhibited the growth of MV4-11 cells harboring the FLT3-ITD mutation (GI50: 10nM). Western blot analysis demonstrated that MAPK and PI3K/AKT pathways in these cells was inhibited with an increasing dose of ON 150030.
Recent Business Highlights:

On April 26, 2017, Onconova closed a public offering resulting in gross proceeds of approximately $5.2 million, before underwriting discounts, commissions and estimated offering costs. New institutional investors, existing investors, as well as Directors and Management of the Company participated in this round. In May 2017, the underwriters exercised their option to purchase an additional 363,580 shares, which is expected to close on May 17, 2017 and will result in additional gross proceeds of $0.8 million.
First-Quarter Financial Results:

Cash and cash equivalents as of March 31, 2017, totaled $15.4 million, compared to $21.4 million as of December 31, 2016. This excludes the proceeds from the financing completed in April 2017, in which the Company raised approximately $5.2 million before underwriting discounts and commissions and estimated offering costs in a public offering of common stock through Laidlaw & Company (UK) Ltd. This also excludes the proceeds from the exercise of the underwriter’s over-allotment option which is expected to raise an additional $0.8 million before deducting underwriting discounts and commissions and estimated offering costs. Onconova believes that its current cash and cash equivalents will be sufficient to fund its ongoing trials and operations to the end of 2017.
Net revenue was $0.2 million for the first quarter of 2017, compared to $1.5 million in the year ago quarter.
Research and development expenses were $4.9 million in the first quarter of 2017, compared to $5.8 million a year ago.
General and administrative expenses were $2.1 million for the first quarter of 2017, compared to $3.2 million for the year-ago period.
The first quarter net loss was $8.3 million, compared to a net loss of $7.2 million in the first quarter of 2016.
The Company will host a conference call on May 15th at 9:00 a.m. Eastern Time to provide a corporate update and discuss first quarter 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: 10612725.

About IV Rigosertib

The intravenous form of rigosertib has been employed in Phase 1, 2, and 3 clinical trials involving more than 800 patients, and is currently being evaluated in the randomized Phase 3 international INSPIRE trial for patients with higher-risk MDS, after failure of hypomethylating agent, or HMA, therapy. This formulation is intended for patients with advanced disease, provides long duration of exposure, and ensures dosing under a controlled setting.

About INSPIRE

The INternational Study of Phase III IV RigosErtib, or INSPIRE, is based on guidance received from the U.S. Food and Drug Administration and European Medicines Agency and derives from the findings of the ONTIME Phase 3 trial. INSPIRE is a multi-center, randomized controlled study to assess the efficacy and safety of IV rigosertib in HR-MDS patients who had progressed on, failed to respond to, or relapsed after previous treatment with an HMA within the first 9 months or nine cycles over the course of one year after initiation of HMA treatment. This time frame optimizes the opportunity to respond to treatment with an HMA prior to declaring treatment failure, as per NCCN Guidelines. The trial will enroll approximately 225 patients randomized at a 2:1 ratio into two treatment arms: IV rigosertib plus Best Supportive Care versus Physician’s Choice plus Best Supportive Care. The primary endpoint of INSPIRE is overall survival and an interim analysis is anticipated. Full details of the INSPIRE trial, such as inclusion and exclusion criteria, as well as secondary endpoints, can be found on clinicaltrials.gov (NCT02562443).

About Oral Rigosertib

The oral form of rigosertib was developed to provide more convenient dosing for use where the duration of treatment may extend to multiple years. This dosage form also supports many combination therapy modalities. To date, 368 patients have been treated with the oral formulation of rigosertib. Initial studies with single-agent oral rigosertib were conducted in hematological malignancies, lower-risk MDS, and solid tumors. Combination therapy of oral rigosertib with azacitidine and chemoradiotherapy has also been explored. Currently, oral rigosertib is being developed as a combination therapy together with azacitidine for patients with higher-risk MDS who require HMA therapy. A Phase 2 trial of the combination therapy has been fully enrolled and the preliminary results were presented in 2016. This novel combination is the subject of an issued US patent with earliest expiration in 2028.