On May 17, 2017 Redx (AIM: REDX) reported its interim results for the six months ended 31 March 2017 (Press release, Redx Pharma, MAY 17, 2017, View Source [SID1234524750]):

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Clinical trial application filed for Porcupine inhibitor RXC004
Development candidate chosen for reversible BTK inhibitor RXC005 for drug resistant chronic lymphocytic leukaemia
Strategic restructuring completed post period; estimated £4.2 million annual cost saving
Iain Ross appointed as Non-Executive Chairman of the Board from 1 May 2017
£12 million gross raised in March 2017, including a subscription with a related sharing agreement
Pipeline highlights
RXC004 — our "best-in-class" Porcupine inhibitor
Clinical trial application (CTA) filed post period in April
Scheduled to enter first-in-human studies upon CTA approval
Shown to have the potential to be used in combination with immune checkpoint inhibitors (anti-PD-1)
RXC005 — our "best-in-class" reversible BTK inhibitor
In vivo proof of concept achieved for the reversible BTK program
Development candidate nominated for drug resistant chronic lymphocytic leukaemia (CLL)
Pre-clinical profile presented at ASH (Free ASH Whitepaper) meeting in December 2016 and iwCLL in May 2017
Investigational new drug (IND) application and CTA to be filed around the end of 2017
Other highlights
Fibrotic disease selected as core immunology research area
Redx acquired the locally acting Rho kinase (ROCK) inhibitor AMA0825 from Amakem NV in March 2017 for an undisclosed amount. ROCK is a promising anti-fibrotic target and AMA0825 is at late lead optimisation stage
Redx was awarded US$1 million competitive grant by CARB-X to enable the Company to advance its Gram-negative anti-infective program with a prospective partner
Key Financials
Net cash at 31 March 2017: £5.1m (2016: £4.4m)
Comprehensive loss: £10.7m (2016: £7.1m)
Strategic refocus expected to deliver annual cost savings of £4.2 million
Dr Neil Murray, Chief Executive Officer of Redx Pharma, commented, "Redx Pharma is now optimally positioned to capitalise on the potential of its world class discovery engine with the transition to clinical development of our two best-in-class assets RXC004 and RXC005 in oncology. I am also excited by the potential of our pipeline in fibrosis, bringing novel medicines to areas of severe unmet need. We look forward to announcing the start of our first clinical trial with RXC004 and to building greater value for our shareholders as a clinical stage business."

Iain Ross, Chairman of Redx Pharma, added,"I have been impressed by the potential of Redx Pharma’s science, approach to drug discovery and the speed with which the Company has created a world class pipeline of best-in-class products. Following the recent re-structuring of the organisation we are now focused on implementing an aggressive strategy to accelerate the "realisation of value" by progressing the clinical and commercial development of our lead programs and maximising the long term potential of the pipeline. I am delighted to be working with the Redx team."

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 17, 2017 AbbVie (NYSE: ABBV), a global biopharmaceutical company, reported it will present data about the company’s portfolio of approved and investigational oncology medicines during the 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), June 2-6, in Chicago. A total of 23 abstracts have been accepted across several tumor types including brain cancer, hematologic malignancies, breast cancer, lung cancer and other solid tumors (Press release, AbbVie, MAY 17, 2017, View Source [SID1234519180]).

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Researchers will present efficacy and safety data on depatuxizumab mafodotin (previously known as ABT-414), an antibody-drug conjugate (ADC) being studied for the treatment of adults with amplified-epidermal growth factor receptor (EGFR) newly diagnosed or recurrent glioblastoma (GBM). GBM is one of the most aggressive cancers, with a five-year survival rate of approximately 6 percent in the U.S. and 24 European countries.1,2 The most common genetic alteration in GBM, EGFR-amplification, occurs in approximately 50 percent of GBM patients.3,4

Additionally, researchers will present data from studies evaluating venetoclax, a BCL-2 inhibitor developed by AbbVie and Genentech, a member of the Roche Group, for investigational uses across multiple hematologic malignancies; ibrutinib, an inhibitor of Bruton’s tyrosine kinase (BTK), across multiple hematologic malignancies and chronic graft versus host disease (cGVHD); rovalpituzumab tesirine (Rova-T), an investigational ADC targeting delta-like protein 3 (DLL3)-expressing tumors in small cell lung cancer (SCLC); veliparib, an investigational oral poly (adenosine diphosphate [ADP]–ribose) polymerase (PARP) inhibitor, across multiple solid tumors; elotuzumab, an immunostimulatory antibody that specifically targets Signaling Lymphocyte Activation Molecule Family member 7 (SLAMF7), a cell-surface glycoprotein; and other early-stage investigational compounds.

AbbVie will also share early-stage research from its oncology pipeline. AbbVie is utilizing technologies and new approaches to help advance cancer therapies that may become foundational to the next generation of cancer treatments.

"AbbVie’s data presentations at this year’s ASCO (Free ASCO Whitepaper) meeting reinforce our diverse and comprehensive oncology pipeline, focused on bringing new medicines to patients, especially in areas where few options exist in cancer," said Tom Hudson, M.D., vice president of oncology discovery and early development, AbbVie. "By combining our deep knowledge in core areas of biology with cutting-edge technologies, and working together with our partners including scientists, industry peers and patients, we aim to discover and develop medicines that will drive transformational improvements in cancer treatment."

AbbVie abstracts:

Ibrutinib

Long-Term Efficacy and Safety with Ibrutinib (ibr) in Previously Treated Chronic Lymphocytic Leukemia (CLL): Up to Four Years Follow-Up of the RESONATE Study; Byrd et al.; Abstract 7510; Poster Discussion Presentation; Monday, June 5, 2017; Poster 8:00 a.m.-11:30 a.m. CDT; Discussion 1:15 p.m.-2:30 p.m. CDT
Ibrutinib vs Chlorambucil: Immunophenotypic and Quantitative Impacts on Circulating Immune Cells in Chronic Lymphocytic Leukemia (CLL); Solman et al.; Abstract 7524; Poster Presentation; Monday, June 5, 2017; 8:00 a.m.-11:30 a.m. CDT
A Randomized, Double-Blind Phase III Study of Ibrutinib versus Placebo in Combination with Corticosteroids in Patients with New Onset Chronic Graft Versus Host Disease; Miklos et al.; Abstract TPS7072; Poster Presentation; Monday, June 5, 2017; 8:00 a.m.-11:30 a.m. CDT
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study of the Bruton’s Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Combination with Rituximab Versus Placebo in Combination with Rituximab in Patients with Treatment-Naïve Follicular Lymphoma (PERSPECTIVE); Fowler et al.; Abstract TPS7576; Poster Presentation; Monday, June 5, 2017; 8:00 a.m.- 11:30 a.m. CDT

Venetoclax

Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Venetoclax Combined with Azacitidine Versus Azacitidine in Treatment-Naïve Patients with Acute Myeloid Leukemia; Potluri et al.; Abstract TPS7069; Poster Presentation; Monday, June 5, 2017; 8:00 a.m.-11:30 a.m. CDT
Phase 2, Open-Label Study of Venetoclax in Combination with Carfilzomib and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma; Bueno et al.; Abstract TPS8056; Poster Presentation; Monday, June 5, 2017; 8:00 a.m.-11:30 a.m. CDT
Venetoclax (VEN) in Patients with Relapsed Non-Hodgkin Lymphoma (NHL); Davids et al.; Publication

Depatuxizumab mafodotin (ABT-414)

Efficacy Analysis of ABT-414 with or without Temozolomide (TMZ) in Patients (pts) with EGFR-Amplified, Recurrent Glioblastoma (rGBM) from a Multicenter, International Phase I Clinical Trial; van den Bent et al.; Abstract 2003; Oral Presentation; Sunday, June 4, 2017; 9:00 a.m.-9:12 a.m. CDT

Rovalpituzumab tesirine (Rova-T)

A Phase III Study of Rovalpituzumab Tesirine Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Patients with Extensive Disease Small Cell Lung Cancer (ED SCLC); Komarnitsky et al.; Abstract TPS8583; Poster Presentation; Saturday, June 3, 2017; 8:00 a.m.-11:30 a.m. CDT
Molecular Profiling of Small Cell Bladder Cancer (SCBC) to Reveal Gene Expression Determinants of Aggressive Phenotype; Koshkin et al.; Abstract 4529; Poster Presentation; Sunday, June 4, 2017; 8:00 a.m.-11:30 a.m. CDT
A Study of Rovalpituzumab Tesirine in Frontline Treatment of Patients with DLL3 Expressing Extensive Small Cell Lung Cancer; Hann et al.; Abstract TPS2598; Poster Presentation; Monday, June 5, 2017; 8:00 a.m.-11:30 a.m. CDT
An Open-Label Study of Rovalpituzumab Tesirine in Patients with DLL3-Expressing Advanced Solid Tumors; Kavalerchik et al.; Abstract TPS2597; Poster Presentation; Monday, June 5, 2017; 8:00 a.m.-11:30 a.m. CDT
Rovalpituzumab Tesirine (Rova-T) as a Therapeutic Agent for Neuroendocrine Prostate Cancer (NEPC); Puca et al.; Abstract 5029; Poster Presentation; Monday, June 5, 2017; 1:15 p.m.-4:45 p.m. CDT

Veliparib

Phase 1/2 Study of Veliparib (V) Combined with Carboplatin (Cb) and Etoposide (E) in Patients (Pts) with Extensive-Stage Disease (ED) Small Cell Lung Cancer (SCLC) and Other Solid Tumors: Phase 1 Results; Atrafi et al.; Abstract 8530; Poster Presentation; Saturday, June 3, 2017; 8:00 a.m.-11:30 a.m. CDT
Tolerability of Veliparib (V) in Combination with Carboplatin (C)/Paclitaxel (P): Based Chemoradiotherapy (CRT) in Subjects with Stage III Non-Small Cell Lung Cancer (NSCLC); Kozono et al.; Abstract 8546; Poster Presentation; Saturday, June 3, 2017; 8:00 a.m.-11:30 a.m. CDT
Breast Conservation after Neoadjuvant Chemotherapy for Triple-Negative Breast Cancer: Surgical Results from an International Randomized Trial (BrighTNess); Golshan et al.; Abstract 514; Poster Discussion Presentation; Sunday, June 4, 2017; Poster 8:00 a.m.-11:30 a.m. CDT; Discussion 11:30 a.m.-12:45 p.m. CDT
Phase 3 Study Evaluating Efficacy and Safety of Veliparib (V) Plus Carboplatin (Cb) or Cb in Combination with Standard Neoadjuvant Chemotherapy (NAC) in Patients (Pts) with Early Stage Triple-Negative Breast Cancer (TNBC); Geyer et al.; Abstract 520; Poster Discussion Presentation; Sunday, June 4, 2017; Poster 8:00 a.m.-11:30 a.m. CDT; Discussion 11:30 a.m.-12:45 p.m. CDT

Elotuzumab

Phase 3 ELOQUENT-2 Study: Extended Four Year Follow-Up (FU) of Elotuzumab Plus Lenalidomide/Dexamethasone (ELd) vs Ld in Relapsed/Refractory Multiple Myeloma (RRMM); Lonial et al.; Abstract 8028; Poster Presentation; Monday, June 5, 2017; 8:00 a.m.-11:30 a.m. CDT
CheckMate 602: An Open-Label, Randomized, Phase 3 Trial of Combinations of Nivolumab, Elotuzumab, Pomalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma; Lonial et al.; Abstract TPS8052; Poster Presentation; Monday, June 5, 2017; 8:00 a.m.-11:30 a.m. CDT

ABBV-221

Preliminary Results from a Phase 1 Study of the Antibody-Drug Conjugate ABBV-221 in Patients with Solid Tumors Likely to Express EGFR; Calvo et al.; Abstract 2510; Poster Discussion Presentation; Monday, June 5, 2017; Poster 8:00 a.m.-11:30 a.m. CDT; Discussion 11:30 a.m.-12:45 p.m. CDT

ABBV-399

Phase I Study of ABBV-399, a c-Met Antibody-Drug Conjugate (ADC), as Monotherapy and in Combination with Erlotinib in Patients (Pts) with Non-Small Cell Lung Cancer (NSCLC); Angevin et al.; Abstract 2509; Poster Discussion Presentation; Monday, June 5, 2017; Poster 8:00 a.m.-11:30 a.m. CDT; Discussion 11:30 a.m.-12:45 p.m. CDT
Impact of MET Inhibitors on Survival Among Patients (Pts) with MET Exon 14 Mutant (METdel14) Non-Small Cell Lung Cancer (NSCLC); Awad et al.; Abstract 8511; Clinical Science Symposium; Sunday, June 4, 2017; 8:00 a.m.-9:30 a.m. CDT

ABT-348

Pharmaco-kinetics/dynamics (PK/PD) Evaluation and Individual Patient Cross-Over Studies with Growth Trajectory Assessment to Adaptively Develop Ilorasertib; Maitland et al.; Abstract 2563; Poster Presentation; Monday, June 5, 2017; 8:00 a.m.-11:30 a.m. CDT

The ASCO (Free ASCO Whitepaper) 2017 Annual Meeting abstracts are available at View Source

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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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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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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