On May 15, 2018 Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company applying synthetic biology to probiotics to develop novel, living medicines, reported its financial results for the first quarter ended March 31, 2018 (Press release, Synlogic, MAY 15, 2018, View Source [SID1234526619]).

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Recent Highlights

Corporate

Leadership Transition: On May 10, 2018, Synlogic announced a CEO transition; Chief Medical Officer, Aoife Brennan, M.B., B.Ch., was appointed to serve as Interim President and Chief Executive Officer as successor to Jose-Carlos Gutiérrez-Ramos, Ph.D.; Peter Barrett, Ph.D., the Chairman of Synlogic’s board of directors will serve as Executive Chairman and oversee a Board committee to conduct a search for a permanent CEO.
Strengthened Company’s balance sheet: As of March 31, 2018, Synlogic had cash, cash equivalents, and short-term investments of $125.8 million. In April 2018, the Company completed a registered direct offering generating $28.9 million in net proceeds. Synlogic expects its current cash, cash equivalents and marketable securities position will be sufficient to fund operations to mid-2020 based on its current business plan.
Pipeline

Treatment of the first subject in a Phase 1/2a clinical trialevaluating SYNB1618, indevelopment for the treatment of phenylketonuria (PKU). This Phase 1/2a clinical trial is a single (SAD) and multiple (MAD) dose-escalation, randomized, double-blind, placebo-controlled study of orally administered SYNB1618 in healthy adult volunteers and adult subjects with PKU. The study is designed to evaluate safety, tolerability, kinetics, and pharmacodynamics as well as exploratory end-points associated with the ability of SYNB1618 to metabolize phenylalanine. Synlogic expects to report interim data from this trial in the second half of 2018 and the full data in 2019. More information about this study can be found at www.clinicaltrials.gov.
Treatment of the first subject in a Phase 1b/2a clinical trial evaluating SYNB1020, in development for the treatment of hyperammonemia. This Phase1b/2a clinical trial is a randomized, double-blind, placebo-controlled study designed to evaluate the safety and tolerability of SYNB1020, as well as its ability to lower blood ammonia levels, in patients with cirrhosis and elevated blood ammonia. Synlogic expects to report topline date from this trial at the end of 2018. Additional information about this study can be found at www.clinicaltrials.gov.
Fast-Track designation granted by the U.S. Food and Drug Administration (FDA) for SYNB1618 for the treatment of PKU. The FDA Fast Track program is designed to facilitate the development of important new drugs intended to treat a serious condition and to fill an unmet medical need. The designation enables early and frequent communication between the FDA and Synlogic ensuring that questions and issues are resolved quickly, and often leading to earlier drug approval and access by patients.
Presentation of preclinical data from Synlogic’s immuno-oncology (IO) program at the annual meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper). The data demonstrate that, in mouse models, Synthetic Biotic medicines stimulate an antitumor response and robustly reprogram the tumor microenvironment, potentially enabling the treatment of a variety of cancers.
First Quarter 2018 Financial Results
For the three months ended March 31, 2018, Synlogic reported a consolidated net loss of $11.2 million, or $0.55 per share, compared to a net loss of $7.4 million, or $4.49 per unit, for the corresponding period in 2017. The increase in net loss was primarily due to increases in compensation-related expenses as Synlogic continues to grow its employee headcount and hire into key positions to support its corporate goals, as well as increases in research and development expenses to support its advancing clinical programs.

Research and development expenses were $8.4 million for the three months ended March 31, 2018 compared to $5.1 million for the corresponding period in 2017. The increase was primarily due to an increase in compensation-related expenses associated with increased headcount, increased external costs associated with process and formulation development, pre-clinical and clinical studies and increased costs associated with Synlogic’s move to a larger facility.

General and administrative expenses for the three months ended March 31, 2018 were $3.6 million compared to $2.4 million for the corresponding period in 2017. The increase was primarily due to increases in compensation-related expenses associated with increased headcount and increases in expenses related to being a newly public company, including audit, legal and investor relations.

As of March 31, 2018, Synlogic had cash, cash equivalents, and short-term investments of $125.8 million.

On May 15, 2018 Moleculin Biotech, Inc., (NASDAQ:MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, reported its financial results for the first quarter ended March 31, 2018 (Press release, Moleculin, MAY 15, 2018, View Source [SID1234526618]). Additionally, the Company announced potential upcoming milestones and recent corporate developments.

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Management Discussion

Walter Klemp, Chairman and CEO of Moleculin, said, "The first quarter of 2018 was very productive as we took important steps to advance the clinical trial of our lead compound, Annamycin for the treatment of relapsed or refractory acute amyloid leukemia ("AML"). We entered into an agreement with The University Hospitals Cleveland Medical Center, which includes the Seidman Cancer Center and the Cleveland Clinic, to participate in our U.S. Phase I/II clinical trial of Annamycin to demonstrate safety and efficacy. The first patients were enrolled and treated without incident beginning in late March 2018. We are also awaiting authorization to proceed with our Annamycin clinical trial in Poland, which, if approved by the Polish National Office, would provide a significant and positive expansion of our trial."

"We are particularly excited with the commencement of the U.S. Annamycin clinical trial because of its unique attributes in treating cancer," continued Mr. Klemp. "Currently approved drugs for AML are limited in their effectiveness by two key flaws: they are often defeated by something called multidrug resistance, which allows cancer cells to build a resistance to the drug, and at the same time, their dosage is limited by their inherent cardiotoxicity, meaning they can do significant and permanent damage to the heart. Annamycin was uniquely designed to avoid these multiple drug resistance mechanisms and exhibits little to no cardiotoxicity. We believe these unique characteristics could make Annamycin an important new treatment option for AML patients."

"Also, during the quarter, we engaged a contract research organization in anticipation of the expansion of the Annamycin clinical trial in Europe; and we entered into an agreement with a European-based manufacturer to begin preparations for commercial scale production of Annamycin as it moves through the approval process.

We remain highly focused on developing treatments for rare and difficult cancers such as AML; glioblastoma; cutaneous T-cell lymphoma, ("CTCL), a deadly form of skin cancer; and pancreatic cancer. We have three highly differentiated technologies with breakthrough potential that, we believe, may effectively treat these difficult cancers. From those three core technologies, we now have six potential oncology drug candidates – one of those drugs is currently in clinical trials – with the possibility of two others commencing clinical trial in 2018. We are off to a good start in the first quarter of 2018 and we look forward to building on that momentum throughout the rest of the year."

First Quarter Highlights and Recent Corporate Developments

Moleculin Announces Engagement with Voisin Consulting Life Sciences to Expand Annamycin Clinical Trial – May 03, 2018, the Company announced that it has engaged Voisin Consulting Life Sciences ("VCLS"), as an additional regulatory consulting firm and contract research organization to prepare for expansion of its clinical trial to study Annamycin for the treatment of relapsed or refractory AML. VCLS headquartered in Paris, France will evaluate Australia and selected Western European countries for the potential expansion of clinical sites for the Company’s AML clinical trial.

Moleculin Announces New Data for Immuno-Stimulating Drug to be Presented at International Conference – April 26, 2018, the Company announced that Dr. Waldemar Priebe, Chair of the Company’s Scientific Advisory Board, has been selected to present findings on Moleculin’s STAT3 inhibitor and immune-stimulating agent, WP1066, at the Global Academic Programs ("GAP") 2018 in Stockholm, Sweden from May 15 to 17, 2018. The annual GAP Conference provides a forum for faculty from MD Anderson and its Sister Institutions to develop collaborations and exchange research results and ideas. The GAP 2018 Conference is being sponsored by a prestigious list of major pharmaceutical companies, including Roche, Bayer, Bristol-Meyers Squibb, AstraZeneca, Novartis, Merck and Pfizer.

Moleculin Enters Agreement with BSP Pharmaceuticals for its Leukemia Drug Candidate – April 24, 2018, the Company announced that it has entered into an agreement with BSP Pharmaceuticals S.p.A to expand production capability for Annamycin. BSP Pharmaceuticals S.p.A., based in Latina, Italy will begin preparations for commercial scale production of the Annamycin drug product. BSP has a solid track record for supplying liposomal formulations to large pharmaceutical companies.

Moleculin Announces Patients Treated in FDA Approved Phase I/II Annamycin Clinical Trial – April 04, 2018, the Company announced that patients have successfully begun treatment in its U.S. Phase I/II clinical trial of Annamycin for the treatment of relapsed or refractory AML. The first patient enrolled in Moleculin’s Annamycin clinical trial was treated at The University Hospitals Cleveland Medical Center Seidman Cancer Center on March 28, 2018.

Moleculin Enters Agreement with Seidman Cancer Center to Conduct Leukemia Clinical Trials Patient -March 27, 2018, the Company announced that it has entered an agreement with The University Hospitals Cleveland Medical Center, which includes the Seidman Cancer Center and the Cleveland Clinic, to participate in its U.S. Phase I/II clinical trial of Annamycin for the treatment of relapsed or refractory AML. Patient enrollment has begun in the Phase I/II trial to demonstrate the safety and effectiveness of Annamycin in the treatment of AML in a U.S. clinical trial.

Moleculin Announces Grant-Funded Collaboration to Expand Understanding of New Discovery – March 20, 2018, the Company announced it has entered into a collaboration with a team of scientists in Poland who have received a $300,000 research grant to expand the understanding of how Moleculin’s leading STAT3 inhibitor WP1066 and the Company’s newly discovered drug candidate, WP1732, create a blockade of transcription factor STAT3 leading to tumor cell death and immune-stimulating effects.

Moleculin Announces Pricing of $9 Million Registered Direct Offering – February 16, 2018, the Company announced that it has entered into a definitive agreement with institutional investors for a registered direct offering of securities with gross proceeds of approximately $9 million.

Moleculin Announces Breakthrough Discovery of a New Molecule for Cancer Treatment – February 15, 2018, the Company announced that, pursuant to its continued collaboration with MD Anderson it has developed and licensed what it believes, based on preclinical testing, is a major breakthrough in its effort to develop a new cancer treatment that selectively kills highly resistant tumors. Specifically, the Company has preclinical evidence to suggest it is capable of influencing a process known as ‘ubiquitination’ to block the activated form of STAT3, an important oncogenic transcription factor. The lead molecule resulting from this new discovery is called WP1732 and it not only appears to share the same key mechanistic properties with WP1066, it has markedly different organ distribution and its dramatically increased solubility makes it ideal for administration via standard IV injection. Importantly, preclinical testing has also shown that WP1732’s properties make it a promising candidate for treating pancreatic cancer.

Moleculin Announces Collaboration with Emory University to Develop Novel Treatment of Pediatric Brain Cancer – February 13, 2018, the Company announced it has entered into an agreement with Emory University to enable expanded cancer research on Moleculin’s WP1066 molecule for the possible treatment of medulloblastoma, a pediatric malignant primary brain tumor. Physician-scientists at Emory University and Children’s Healthcare of Atlanta have requested support to continue research aimed at the development of a novel treatment of medulloblastoma using WP1066 and Moleculin has agreed to supply them with a pure form of WP1066 for preclinical testing for the potential future treatment of patients with the disease. Emory studies so far have indicated that medulloblastoma may be particularly vulnerable to the ability of WP1066 to block the activated form of STAT3, a key signaling protein believed to contribute to the growth and survival of many tumors, including medulloblastoma.

Moleculin Announces Activity with Pancreatic Cancer Drug – February 7, 2018, the Company announced it has been able to show promising tumor suppression activity with its inhibitor of glycolysis, WP1122. The Company’s glycolysis inhibitors have shown a remarkable affinity for concentrating in the pancreas and has solid data showing the ability of WP1122 to inhibit pancreatic tumor growth in mice.

Leading Leukemia Experts Join Moleculin’s Science Advisory Board – January 17, 2018, the Company
announced the expansion of its Science Advisory Board to include Drs. Jorge Cortes and Elihu Estey.

Jorge Cortes, M.D., is deputy chair and professor of medicine in the Department of Leukemia at MD Anderson Cancer Center where he directs the CML and AML Programs. Dr. Cortes received his medical degree in 1986 from the Universidad Nacional Autonoma de Mexico, and has been at MD Anderson since 1991. Dr. Cortes, whose clinical interest focuses on new drug development and the management of patients with myelodysplatic syndromes, acute and chronic leukemias, and myeloproliferative disorders, has authored over 900 peer-reviewed medical publications in top-tier journals including New England Journal of Medicine, Lancet Oncology, Lancet Hematology, Journal of Clinical Oncology, Leukemia, Blood and many others.

Elihu Estey, M.D., is a Professor of Medicine in the Division of Hematology at the University of Washington School of Medicine and a Full Member and Director of AML Clinical Research (non-transplant) Clinical Research Division, Fred Hutchinson Cancer Research Center. Dr. Estey has built a distinguished career in cancer research approaching 40 years of active clinical practice with AML patients, providing mentorships for many physicians that have risen to prominence in AML, lectured globally to professional audiences on cancer research and published more than 700 articles on hematologic malignancies, specifically on AML. Additionally, Dr. Estey serves on the European Leukemia Net (ELN) guidelines committee for AML and has served as an advisor for AML studies to the Oncology Drugs Advisory Committee of the FDA.

Moleculin Expands Leukemia Development Portfolio with Immuno-Stimulating STAT3 Inhibitor – January 10, 2018, the Company announced it has expanded the Company’s development pipeline for the treatment of AML with an immuno-stimulating STAT3 inhibitor. Leading experts in the treatment of AML, Dr. Jorge Cortes and Dr. Sanjay Awasthi requested the Company to expand its clinical research to include WP1066, an immuno-stimulating agent and STAT3 inhibitor, to increase therapeutic options for AML patients. This would potentially be complementary and synergistic with Annamycin and existing first line treatments.

Anticipated Milestone Potential Timeframe
Announcement that our IND for Annamycin has become effective and that we may begin clinical trials Accomplished
Initial IRB (Institutional Review Board) approvals and site initiations of various clinical sites participating in our Phase I/II clinical trial of Annamycin Accomplished and ongoing through Second Half of 2018
Establishment of a new Recommended Phase 2 Dose for Annamycin Second Half of 2018
A clinician sponsored IND for WP1066 for treatment of adult brain tumors moving forward IND Accomplished; Trial expected to begin First Half of 2018
Announcement of initial clinical data for Annamycin trial 2018
Announcement of further benefits of our sponsored research agreement with MD Anderson Accomplished and Ongoing into 2019
Announce CTA for WP1220 for the treatment of cutaneous T-cell lymphoma (CTCL) 2018
Announce WP1122 and WP1732 move into preclinical work 2018
Announce the fourth drug approved for clinical trial 2019
Financial Results for the First Quarter Ended March 31, 2018

Research and Development Expense. Research and development (R&D) expense was $1.2 million and $0.7 million for the three months ended March 31, 2018 and 2017, respectively. The increase of approximately $0.5 million mainly represents an increase of approximately: $0.2 million related to an increase in R&D associated headcount costs; $0.1 million for sponsored research and related expenses; and, approximately $0.2 million associated with developing and testing drug product as we prepared our IND for Annamycin and for the related clinical trials.

General and Administrative Expense. General and administrative expense was $1.4 million and $0.8 million for the three months ended March 31, 2018 and 2017, respectively. The increase of approximately $0.6 million was mainly attributable to the increase in headcount and associated payroll costs of $0.3 million; $0.1 million of stock-based compensation; and, approximately $0.2 million in other expenses. Such increases are due to the increased corporate activity as the Company enters clinical trials.

Net Loss. The net loss for the three months ended March 31, 2018 was $1.9 million which included non-cash income of $0.2 million related to stock-based compensation and other stock-based expenses.

Liquidity and Capital Resources

As of March 31, 2018, the Company had $13.1 million in cash and cash equivalents. On February 16, 2018, the Company entered into a Securities Purchase Agreement with certain institutional investors for the sale by us of 4,290,000 shares of our common stock, at a purchase price of $2.10 per share. Concurrently with the sale of the common shares, pursuant to the Purchase Agreement, we also sold warrants to purchase 2,145,000 shares of common stock. We sold the common shares and warrants for aggregate gross proceeds of approximately $9.0 million. Subject to certain beneficial ownership limitations, the warrants will be initially exercisable on the six-month anniversary of the issuance date at an exercise price equal to $2.80 per share of common stock, subject to adjustments as provided under the terms of the warrants. The warrants are exercisable for five years from the initial exercise date. The closing of the sales of these securities under the Purchase Agreement occurred on February 21, 2018. The net proceeds from the transactions was approximately $8.2 million after deducting certain fees due to the placement agent and transaction expenses. The net proceeds will be used for planned clinical trials, preclinical programs, for other research and development activities and for general corporate purposes. The Company believes that its existing cash and cash equivalents as of March 31, 2018 will be sufficient to fund our planned operations into the first quarter of 2019. Such plans are subject to change depending on clinical enrollment progress and use of drug product.

On May 15, 2018 Heat Biologics, Inc. (NASDAQ: HTBX), a biopharmaceutical company developing drugs designed to activate a patient’s immune system against cancer, reported financial and clinical updates for the first quarter ended March 31, 2018 (Press release, Heat Biologics, MAY 15, 2018, View Source [SID1234526617]).

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”We had an eventful first quarter, with a number of positive clinical developments,” said Jeff Wolf, CEO of Heat. ”Most notably, we announced positive interim results from our Phase 2 study investigating HS-110 in combination with Bristol-Myers Squibb’s anti-PD-1 checkpoint inhibitor, nivolumab (Opdivo), in patients with advanced non-small cell lung cancer (NSCLC) whose cancers had progressed after treatment with one or more lines of therapy. These data are especially encouraging in patients with low levels of TIL and PD-L1, who are among the most difficult-to-treat patients. Importantly, we believe the data are consistent with the mechanism of action of our T-cell Activation Platform, which has been shown to promote a robust T-cell immune response. We believe the ability of our platform to convert ”cold tumors” to ”hot tumors” will be an important component in effective immunotherapy combinations against cancer.”

”Given the strength of our recent data, we recently completed a capital raise for gross proceeds of $20.7 million. Consequently, Heat should have sufficient capital to accomplish the following key objectives over the next 5 quarters: 1) complete enrollment in our Phase 2 trial for HS-110 in NSCLC, 2) begin patient enrollment for our ComPact platform, 3) undertake our Phase I study with our first-in-class T cell costimulator antibody, PTX-35, and 4) report preliminary data for each of these trials.”

First Quarter 2018 Corporate Highlights

On March 26, 2018, the Company reported 2-year recurrence rate data from the Phase 2 trial evaluating HS-410 (vesigenurtacel-L) in combination with standard of care, Bacillus Calmette-Guérin (BCG), for the treatment of non-muscle invasive bladder cancer (NMIBC); achieved 100% (10 out of 10) disease free survival rate over 2 years in the subgroup of patients that generated a positive immune response to low-dose HS-410 and BCG.
On March 19, 2018, the Company announced the appointment of Anthony Tolcher, M.D., FRCPC, FACP, to the scientific advisory boards of Heat Biologics and its subsidiary, Pelican Therapeutics.
On March 12, 2018, the Board of Directors adopted a stockholder rights plan intended to ensure that all stockholders of the Company receive fair and equal treatment in the event of an attempted hostile takeover of the Company.
On February 28, 2018, the Company announced positive interim data from its Phase 2 clinical trial of HS-110 and Nivolumab in NSCLC; reported tumor shrinkage and disease control in a majority of evaluable patients; HS-110 + nivolumab combination showed durable responses in difficult-to-treat low TIL patients and low PD-L1 patients who respond poorly to checkpoint inhibitors.
On February 20, 2018, the Company reported that the Independent Data Monitoring Committee (DMC) recommended continuing patient enrollment in the ongoing Phase 2 Clinical Trial for HS-110.
On February 14, 2018, the Company announced its abstract highlighting interim results of its Phase 2 study on HS-110 had been accepted as a scientific poster presentation during the 2018 Keystone Symposia Conference XI: Immunological Memory: Innate, Adaptive and Beyond, February 25 – March 1, 2018 which took place in Austin, TX.
First Quarter 2018 Financial Results

Recognized $0.8 million of grant revenue for qualified expenditures under the CPRIT grant.
Research and development expenses increased to $2.9 million for the quarter ended March 31, 2018 compared to $1.8 million for the quarter ended March 31, 2017. The $1.1 million increase is due to an increase in CMC activity in our HS-110 and PTX-35 programs as well as continued patient enrollment as we progress in our phase 2 HS-110 clinical trial.
General and administrative expense increased approximately 20% to $1.8 million for the quarter ended March 31, 2018 compared to $1.5 million for the quarter ended March 31, 2017. The $0.3 million increase is primarily attributable to the increase in personnel costs as we establish our Texas operations associated with our Pelican subsidiary.
Net loss attributable to Heat Biologics was approximately $3.5 million, or ($0.75) per basic and diluted share for the quarter ended March 31, 2018 compared to a net loss of approximately $3.2 million, or ($1.18) per basic and diluted share for the quarter ended March 31, 2017.
As of March 31, 2018, the Company had approximately $9.0 million in cash and cash equivalents. Subsequent to the end of the first quarter, the Company raised approximately $20.7 million in gross proceeds in a public offering of common shares and warrants.

On May 15, 2018 GTx, Inc. (Nasdaq:GTXI) reported financial results for the first quarter ended March 31, 2018 and highlighted recent accomplishments and upcoming milestones (Press release, GTx, MAY 15, 2018, View Source;p=RssLanding&cat=news&id=2349054 [SID1234526616]).

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"GTx is off to a strong start in 2018, with data presented at the SUFU Meeting in March supporting enobosarm’s potential to treat stress urinary incontinence (SUI). The data included additional positive results in a subset of women with both SUI and urge incontinence," said Robert J. Wills, Ph.D., Executive Chairman of GTx. "We look forward to presenting additional data from our open-label, Phase 2 proof-of-concept clinical trial evaluating enobosarm 3 mg in postmenopausal women with SUI at the upcoming AUA meeting in May. In addition, we completed patient enrollment in our placebo-controlled, Phase 2 clinical trial of enobosarm in postmenopausal women with SUI several months ahead of schedule. Enrollment exceeded the 400 patients planned per protocol, and we are eager to report top-line results early in the fourth quarter of 2018."

Clinical Highlights and Anticipated Milestones

Stress Urinary Incontinence (SUI):

Enobosarm, a Selective Androgen Receptor Modulator (SARM), is being evaluated in Phase 2 clinical development for SUI, the Company’s lead indication. Recent and upcoming important milestones are summarized as follows:

At the Society of Urodynamics, Female Pelvic Medicine, & Urogenital Reconstruction (SUFU) Meeting in March, positive results were presented from the Company’s Phase 2 proof-of-concept (POC) clinical trial of enobosarm 3 mg administered orally in post-menopausal women with SUI. Details of the SUFU presentation can be found here and are summarized below:
At the end of the 12-week treatment period, all 18 enobosarm-treated women demonstrated clinically meaningful (50 percent or greater) reductions in stress urinary incontinence episodes per day, compared to baseline.
The reduction in incontinence episodes was sustained, or durable, well beyond the 12-week treatment period.
Additional positive results in a subset of postmenopausal women suggest a dual treatment effect on both SUI and urge incontinence (UI).
Magnetic resonance imaging (MRI) results showed a statistically significant increase in several important measurements and support the mechanism of action of enobosarm on the pelvic floor.
There were no serious adverse events reported and reported adverse events were minimal and included headaches, nausea, fatigue, hot flashes, insomnia, muscle weakness and acne. Mild transient elevations in liver enzymes that were within normal limits were observed, except for one patient with levels greater than 1.5 times the upper limit of normal which returned to normal following her 12-week treatment period. Reductions in total cholesterol, LDL-C, HDL-C and triglycerides were also observed.
On May 18, 2018, a podium presentation at the 2018 American Urological Association (AUA) meeting will update results from the Phase 2 POC clinical trial of enobosarm.
The Company has an ongoing randomized, double-blinded, placebo-controlled, Phase 2 trial to assess the efficacy and safety of enobosarm administered orally in post-menopausal women with SUI compared to placebo. More information about the ASTRID (Assessing Enobosarm for Stress Urinary Incontinence Disorder) trial can be found here.
In April, the Company completed patient enrollment in the ASTRID trial several months ahead of schedule, enrolling 493 women at over 60 clinical trial centers across the United States. Top-line results are expected early in the fourth quarter of 2018.
Prostate Cancer:

The Company has a Selective Androgen Receptor Degrader (SARD) preclinical program to evaluate its novel SARD technology in castration-resistant prostate cancer (CRPC). The Company has ongoing mechanistic preclinical studies designed to select the most appropriate compound to potentially advance into a first-in-human clinical trial.

First Quarter 2018 Financial Results

As of March 31, 2018, cash and short-term investments were $32.1 million compared to $43.9 million at December 31, 2017.
Research and development expenses for the quarter ended March 31, 2018 were $11.0 million compared to $4.2 million for the same period of 2017.
General and administrative expenses for the quarter ended March 31, 2018 were $2.7 million compared to $2.1 million for the same period of 2017.
The net loss for the quarter ended March 31, 2018 was $13.6 million compared to a net loss of $6.3 million for the same period in 2017.
GTx had approximately 22.5 million shares of common stock outstanding as of March 31, 2018. Additionally, there are warrants outstanding to purchase approximately 5.3 million shares of GTx common stock at an exercise price of $8.50 per share and approximately 3.3 million shares of GTx common stock at an exercise price of $9.02.
About the Phase 2 Proof-of-Concept Clinical Trial

The single-arm, open-label Phase 2 clinical trial is evaluating enobosarm in postmenopausal women with SUI, and is the first clinical trial to evaluate an orally-administered selective androgen receptor modulator (SARM) for SUI. This clinical trial is closed to enrollment; more information about the clinical trial can be found here.

About the Phase 2 ASTRID Clinical Trial

In addition to the Phase 2 proof-of-concept clinical trial being presented at AUA, GTx also has a larger, ongoing, placebo-controlled Phase 2 clinical trial evaluating enobosarm in postmenopausal women with SUI. The study, called ASTRID (Assessing Enobosarm for Stress Urinary Incontinence Disorder), completed enrollment (n=493) recently and is being conducted at over 60 clinical trial centers across the United States. Top-line results are expected early in the fourth quarter of this year. More information about the ASTRID clinical trial can be found here.

About Enobosarm and SUI

Enobosarm (GTx-024), a selective androgen receptor modulator (SARM), has been evaluated in 25 completed or ongoing clinical trials enrolling over 2,100 subjects, in which approximately 1,500 subjects were treated with enobosarm at doses ranging from 0.1 mg to 100 mg. At all evaluated dose levels, enobosarm was observed to be generally safe and well tolerated. The rationale for evaluating enobosarm as a treatment for SUI is supported by preclinical in vivo data demonstrating increases in pelvic floor muscle mass following treatment with GTx’s SARM compounds, including enobosarm, and the proof-of-concept Phase 2 clinical trial of enobosarm 3 mg for the treatment of postmenopausal women with SUI.

About Stress Urinary Incontinence

Stress urinary incontinence (SUI) refers to the unintentional leakage of urine during activities that increase abdominal pressure such as coughing, sneezing or physical exercise. SUI, the most common type of incontinence suffered by women, affects up to 35 percent of adult women. There are a variety of treatments that are used to treat SUI in women, such as behavioral modification and pelvic floor physical therapy, especially as initial treatment options. As the condition worsens however, bulking agents and surgical procedures are often the most widely used treatments

On May 15, 2018 Cleveland BioLabs, Inc. (NASDAQ:CBLI) reported financial results and development progress for the first quarter ended March 31, 2018 (Press release, Cleveland BioLabs, MAY 15, 2018, View Source [SID1234526615]).

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Cleveland BioLabs reported a net loss of $(1.2) million, excluding minority interests, for the first quarter of 2018, or $(0.11) per share, compared to a net loss, excluding minority interests, of $(1.7) million, or $(0.15) per share, for the same period in 2017. The decrease in net loss was primarily due to a non-cash adjustment to our warrant liabilities and reduced operating costs partially offset by reduced revenue.

As of March 31, 2018, the Company had $7.7 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 past quarter was one of important progress for the company and our Entolimod program. We continued our pursuit of 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 previously reported, the company has received Day 120 review questions from EMA regarding the MAA for entolimod and a formal notification that responses to these questions should be submitted to the agency by September 14, 2018. Consistent with the FDA review of the company’s pre-EUA application, several of the EMA review questions focused on the comparability between the entolimod formulation used in prior safety and efficacy studies and the formulation proposed for commercialization. The analytical analysis of the specimens collected during an in-vivo biocomparability study in non-human primates to address these comparability questions is ongoing," added Dr. Kogan. "Other Day 120 questions from the EMA are generally similar to those discussed in the past with the FDA, and include questions on validation of various aspects of manufacturing, the animal-to-human dose-conversion strategy, and the human safety database."

Further Financial Results

Revenue for the first quarter of 2018 decreased to $0.2 million compared to $0.6 million for the first quarter of 2017. The decrease was primarily due to decreased revenue from our Joint Warfighter Medical Research Program contract from the Department of Defense for the continued development of the entolimod as a medical radiation countermeasure.

Research and development costs for the first quarter of 2018 decreased to $1.3 million compared to $1.4 million for the first quarter of 2017. The reduction in research and development costs is primarily due to reductions in entolimod for biodefense applications partially offset by increases in the entolimod family of compounds for oncology.

General and administrative costs for the first quarter of 2018 decreased to $0.7 million compared to $0.8 million for the first quarter of 2017. This decrease was primarily attributable to reductions in personnel and other operating costs in connection with cost savings efforts to streamline operations.