On May 18, 2017 Sumitomo Dainippon Pharma Co., Ltd. (Head Office: Osaka, Japan; President: Masayo Tada) reported that a total of 12 presentations including clinical data for investigational anti-cancer agents napabucasin (BBI608), amcasertib (BBI503) and WT2725 will be presented at the poster session of the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago from June 2 to June 6, 2017 (Press release, Dainippon Sumitomo Pharma, MAY 17, 2017, View Source [SID1234519264]).

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Napabucasin: Study results, 7 presentations Abstract number Title of poster presentation Date and Time, Location Study number Cancer Type 9052 A phase 1b/2 study of napabucasin with weekly paclitaxel in advanced, previously treated non-squamous non-small cell lung cancer. June 3, 2017 8：00 AM-11：30 AM (local time), Hall A 201 Study： NCT01325441 Non-small cell lung cancer 3529 Phase 1b/II study of cancer stemness inhibitor napabucasin (BBI-608) in combination with FOLFIRI +/- bevacizumab (bev) in metastatic colorectal cancer (mCRC) patients (pts). June 3, 2017 8：00 AM-11：30 AM (local time), Hall A 246 Study： NCT02024607 Colorectal cancer 4106 A phase Ib/II study of cancer stemness inhibitor napabucasin (BBI-608) in combination with gemcitabine (gem) and nab-paclitaxel (nabPTX) in metastatic pancreatic adenocarcinoma (mPDAC) patients (pts). June 3, 2017 8：00 AM-11：30 AM (local time), Hall A 118 Study： NCT02231723 Pancreatic cancer 5548 A phase 1b/2 study of napabucasin with weekly paclitaxel in advanced, previously treated platinum resistant ovarian cancer. June 3, 2017 1：15 PM-4：45 PM (local time) , Hall A 201 Study： NCT01325441 Ovarian Cancer 9553 A phase Ib study of napabucasin plus weekly paclitaxel in patients with advanced melanoma. June 3, 2017 1：15 PM-4：45 PM (local time) , Hall A 201 Study： NCT01325441 Melanoma 2 1084 A phase 2 study of napabucasin with weekly paclitaxel in previously treated metastatic breast cancer. June 4, 2017 8：00 AM-11：30 AM (local time) , Hall A 201 Study： NCT01325441 Breast cancer 4077 BBI608-503-103HCC: A phase Ib/II clinical study of napabucasin (BBI608) in combination with sorafenib or amcasertib (BBI503) in combination with sorafenib (Sor) in adult patients with hepatocellular carcinoma (HCC). June 3, 2017 8：00 AM-11：30 AM (local time) , Hall A BBI HCC 103 Study： NCT02279719 Hepatocellular carcinoma

Napabucasin: Study design, 2 presentations Abstract number Title of poster presentation Date and Time, Location Study number Cancer Type TPS3619 CanStem303C trial: A phase III study of napabucasin (BBI-608) in combination with 5-fluorouracil (5-FU), leucovorin, irinotecan (FOLFIRI) in adult patients with previously treated metastatic colorectal cancer (mCRC). June 3, 2017 8：00 AM-11：30 AM (local time) , Hall A CanStem303C Study： NCT02753127 Colorectal cancer TPS4148 CanStem111P trial: A phase III study of napabucasin (BBI-608) plus nab-paclitaxel (nab-PTX) with gemcitabine (gem) in adult patients with metastatic pancreatic adenocarcinoma (mPDAC). June 3, 2017 8：00 AM-11：30 AM (local time) , Hall A CanStem111P Study： NCT02993731 Pancreatic cancer

Amcasertib: Study results, 2 presentations Abstract number Title of poster presentation Date and Time, Location Study number Cancer Type 6032 A phase 1b/2 study of amcasertib, a first-in-class cancer stemness kinase inhibitor in advanced head and neck cancer. June 5, 2017 1：15 PM-4：45 PM (local time) , Hall A 101 Study： NCT01781455 Head and Neck cancer 6036 A phase 1b/2 study of amcasertib, a first-in-class cancer stemness kinase inhibitor, in advanced adenoid cystic carcinoma. June 5, 2017 1：15 PM-4：45 PM (local time), Hall A 101 Study： NCT01781455 Adenoid Cystic Carcinoma 3

WT2725: Study results, 1 presentation Abstract number Title of poster presentation Date and Time, Location Study number Cancer Type 2066 Initial phase 1 study of WT2725 dosing emulsion in patients with advanced malignancies. June 5, 2017 1：15 PM-4：45 PM (local time), Hall A D8350004Study ：NCT01621542 Solid tumors, Hematologic malignancies *The abstract is now available on the official website of ASCO (Free ASCO Whitepaper). There is the link to applicable abstract on abstract number of each study. (Reference)

【About napabucasin:BBI608】 Napabucasin is an investigational first-in-class anti-cancer agent created by Boston Biomedical, Inc., wholly-owned subsidiary of Sumitomo Dainippon Pharma. Napabucasin is an orally -administered small molecule agent with a novel mechanism of action designed to inhibit cancer stemness pathways by targeting STAT3.

【About amcasertib:BBI503】 Amcasertib is an investigational anti-cancer agent created by Boston Biomedical, Inc. Amcasertib is an orally-administered small molecule agent with a novel mechanism of action designed to inhibit cancer stemness pathways, including Nanog, by targeting stemness kinases.

【About WT2725】 WT2725 is an investigational therapeutic cancer peptide vaccine derived from Wilms’ tumor gene 1 (WT1) protein. WT2725 is expected to treat various types of hematologic malignancies and solid tumors that express WT1, by inducing WT1-specific cytotoxic T-lymphocytes that attack WT1-expressing cancer cells.

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 Moleculin Biotech, Inc. Reports Financial Results for the First Quarter Ended March 31, 2017.

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.

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RestorGenex has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, RestorGenex, MAY 15, 2017, View Source [SID1234519161]).

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Aeolus has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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AmpliPhi Biosciences has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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