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MATEON THERAPEUTICS REPORTS SECOND QUARTER 2018 FINANCIAL RESULTS

On August 14, 2018 Mateon Therapeutics, Inc. (OTCQB:MATN), a biopharmaceutical company developing investigational drugs for the treatment of orphan oncology indications, reported second quarter 2018 financial results (Press release, Mateon Therapeutics, AUG 14, 2018, View Source [SID1234528884]).

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For the three months ended June 30, 2018, Mateon reported a net loss of $0.6 million, compared to a net loss of $3.9 million reported for the three months ended June 30, 2017. R&D expenses decreased to $0.3 million for the second quarter of 2018 compared to $3.0 million for the same period in 2017, while general and administrative expenses decreased to $0.6 million for the second quarter of 2018 compared to $0.9 million for the same period in 2017. In the second quarter of 2018, Mateon reported non-operating income of $0.3 million. As of June 30, 2018, Mateon had cash and cash equivalents of $2.0 million.

"Following the closing of our financing transaction in April, we re-initiated enrollment into our study of OXi4503 for relapsed/refractory acute myeloid leukemia and myelodysplastic syndromes. We continue to enroll patients into the trial’s sixth cohort, and are approximately halfway to our current ten patient target," said William D. Schwieterman, M.D., Chief Executive Officer of Mateon Therapeutics. "We also are close to finalizing our regulatory submission for a new clinical phase 2a study in patients with advanced melanoma, where we will be using CA4P as an immuno-oncology agent in combination with Opdivo. We have shown in animal studies that the necrotic tumor cell death induced by CA4P strongly stimulates an anti-tumor immune response when used in combination with checkpoint inhibitors, and are hopeful it will do the same in patients with metastatic melanoma who have failed currently approved treatments."

RXI PHARMACEUTICALS REPORTS SECOND QUARTER 2018 FINANCIAL RESULTS AND RECENT CORPORATE HIGHLIGHTS

On August 14, 2018 RXi Pharmaceuticals Corporation (NASDAQ: RXII) a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (sd-rxRNA) therapeutic platform reported its financial results for the second quarter ended June 30, 2018 and provided a business update (Press release, RXi Pharmaceuticals, AUG 14, 2018, View Source [SID1234528883]).

"The Q2 financial report provides good insights into the progress of the transition announced in January 2018, when RXi management informed its shareholders of the corporate focus on immuno-oncology and adoptive cell transfer therapy," said Dr. Geert Cauwenbergh, President & CEO of RXi Pharmaceuticals. He added that, "For the first 6 months of 2018, spending has been reduced by 26% as compared to the first half of 2017, with about half the reduction from one-time charges relating to the acquisition of MirImmune in Q1 of 2017, and the remainder resulting from a reduction in general and administrative expenses as compared to the same period last year." He indicated that: "The successful completion of our clinical studies in dermatology and ophthalmology have added significant human clinical data on efficacy and safety of the sd-rxRNA platform to our data packages, that should be valuable for companies that are considering a potential acquisition of those assets, including potential licenses to our self-delivering platform for those therapeutic categories. We would expect the execution of such an agreement to provide us with non-dilutive cash that could extend our financial runway significantly." He finally added that: "In comparison with our track record for deal-making in dermatology and ophthalmology between 2012 and 2017, our partnering history of the past 9 months, including strong IO & ACT partnerships with leading academic and industrial partners, indicates a much better visibility with stronger interest in our sd-rxRNA approach than ever before. We aim to take advantage of this surge in partnering interest, to enhance the value of our Company for our shareholders."

The Company will host a conference call today at 4:30 p.m. ET to discuss financial results and provide an update on the Company. The webcast link will be available under the "Investors – Event Calendar" section of the Company’s website, www.rxipharma.com. The event may also be accessed by dialing toll-free in the United States and Canada: +1 844-376-4678. International participants may access the event by dialing: +1 209-905-5958. An archive of the webcast will be available on the Company’s website approximately two hours after the presentation.

Select Second Quarter 2018 Financial Highlights

Cash Position

At June 30, 2018, the Company had cash and cash equivalents of $5.3 million as compared with $3.6 million at December 31, 2017.

On April 11, 2018, the Company closed on a registered direct offering of 1,510,604 shares of the Company’s common stock at a purchase price of $3.15 per share. Concurrently, the Company also commenced a private placement, whereby it issued and sold warrants exercisable for a total of 1,132,953 shares of common stock with a purchase price per share of $0.125 per underlying warrant share and with an exercise price of $3.15 per share. Assuming the warrants are not exercised, net proceeds to the Company were approximately $4.2 million after deducting placement agent fees and estimated offering expenses.

Under the Company’s purchase agreement with Lincoln Park Capital Fund, LLC ("LPC"), the Company sold a total of 420,000 shares of common stock to LPC for net proceeds of approximately $1.3 million during the six months ended June 30, 2018. There remains approximately $13 million available under the purchase agreement with LPC, subject to certain limitations and conditions set forth therein.

Revenues

Revenues for the three months ended June 30, 2018 were $58,000 and related to the work performed by the Company as a sub-awardee under the government grant awarded to our collaborator BioAxone Biosciences, Inc. from the National Institute of Neurological Disorders and Stroke. The grant provides funding for the development of a novel sd-rxRNA compound, BA-434, that targets PTEN for the treatment of spinal cord injury. The Company had no revenues during the three months ended June 30, 2017.

Research and Development Expenses

Research and development expenses for the quarter ended June 30, 2018 were $1.2 million, as compared with $1.3 million for the quarter ended June 30, 2017. The decrease was primarily due to a decrease in clinical-trial related expenses as subject participation is now complete for all of the Company’s clinical trials.

Acquired In-process Research and Development Expense

The Company did not have acquired in-process research and development expense for the three months ended June 30, 2018. During the three months ended June 30, 2017, the Company recorded acquired in-process research and development expense related to the fair value of consideration given in the acquisition of MirImmune.

General and Administrative Expenses

General and administrative expenses for the quarter ended June 30, 2018 were $0.8 million, as compared with $1.1 million for the quarter ended June 30, 2017. The decrease was primarily due to decreases in professional fees for legal-related services and payroll-related expenses as a result of a decrease in headcount.

Net Loss

Net loss for the quarter ended June 30, 2018 was $1.9 million, compared with $2.5 million for the quarter ended June 30, 2017. The decrease was primarily due to a decrease in operating expenses, as discussed above.

Select Second Quarter 2018 and Recent Corporate Highlights

Select Business and Corporate Highlights

Immuno-oncology

In addition to its internal development programs, the Company has entered into several partnerships across the globe to expand its pipeline to advance development of the next generation immunotherapies for the treatment of cancer. In May 2018, RXi established a research collaboration with Iovance Biotherapeutics to evaluate potential synergies between RXi’s novel sd-rxRNA therapeutic compounds and Iovance’s autologous cell therapy based on tumor-infiltrating lymphocytes (TILs) for use in the treatment of cancer.

On April 16, 2018, the journal Molecular Therapy published "Self-Delivering RNAi (sd-rxRNA) Targeting PD-1 using Adoptive Cell Therapy Approach for the Treatment of Malignant Melanoma". In this paper scientists demonstrate the potential of improving therapy with patient-derived tumor infiltrating lymphocytes (TILs) by treatment with RXi’s novel sd-rxRNA compound that specifically targets PD-1.

Clinical Trials – Dermatology and Opthalmology

The Company issued positive news from both its Dermatology and Opthalmology Franchises, with each franchise comprising advanced clinical programs, robust discovery assets and substantial Intellectual Property rights. The Company has an active process underway to monetize these assets, which would support a return on investment for stockholders and accelerated growth in the immuno-oncology focus area.

Samcyprone for the Treatment of Cutaneous Warts

Samcyprone is a proprietary topical formulation of the small molecule diphenylcyclopropenone (DPCP), a topical immunomodulator that works by initiating a T-cell response. Completed Phase 2 trial RXI-SCP-1502, was a multi-center, multi-dose trial conducted in subjects with at least one cutaneous, plantar or periungual wart present for at least four weeks. The study successfully met its primary effectiveness objectives and its secondary safety and tolerability objectives. In addition to the key study objectives, a large amount of data was collected that can inform the design of further pivotal studies in support of future marketing applications.

RXI-109 for the Reduction of Retinal Scarring

RXI-109 is a self-delivering therapeutic RNAi compound that targets connective tissue growth factor (CTGF), a key regulator in fibrosis and scar formation. RXI-109-1501 was a multi-dose, dose escalation trial conducted in subjects with advanced neovascular or ‘wet’ age-related macular degeneration and accompanying subretinal fibrosis. This study successfully met its primary objective by showing that RXI-109 is safe and well tolerated in this dose escalation study. This was shown by the absence of dose-limiting and serious toxicities, and only mild to moderate procedure-related adverse events. None of the adverse events were drug related. In addition, comprehensive ocular examinations showed no indications of inflammation or any other tolerability issues related to the treatment. In addition, RXI-109 met its secondary objectives, with improved or stable disease in the study eyes in several subjects.

Intellectual Property

The European Patent Office (EPO) and Japan Patent Office (JPO) have granted patents for the Company’s novel self-delivering RNAi (sd-rxRNA) therapeutic platform. The EPO Patent #: 2949752 B1 and JPO Patent #: 620309 cover composition of matter, specifically structural and chemical attributes of sd-rxRNA. These patents will be set to expire in 2029.

Stemline Therapeutics to Present at the 2018 Wedbush PacGrow Healthcare Conference

On August 14, 2018 Stemline Therapeutics, Inc. (Nasdaq: STML), a clinical-stage biopharmaceutical company developing novel oncology therapeutics, reported that Ivan Bergstein, M.D., Stemline’s CEO, will present at the 2018 Wedbush PacGrow Healthcare Conference on Wednesday, August 15, 2018 at 10:55 AM ET at the Parker New York Hotel (Press release, Stemline Therapeutics, AUG 14, 2018, View Source [SID1234528882]). A live webcast of the presentation can be viewed on the company’s website at www.stemline.com.

About ELZONRISTM (tagraxofusp; SL-401)
ELZONRISTM (tagraxofusp; SL-401) is a novel targeted investigational therapy directed to CD123, a cell surface receptor expressed on a range of malignancies. ELZONRIS successfully completed a pivotal trial in patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), and a Biologics License Application (BLA) in this indication has been accepted for filing and been granted Priority Review by the U.S. Food and Drug Administration (FDA). ELZONRIS has also been granted Breakthrough Therapy Designation (BTD) and Orphan Drug Designation by the FDA. ELZONRIS is also being evaluated in clinical trials in additional indications including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF), and others.

About BPDCN
Please visit the BPDCN disease awareness website: www.bpdcninfo.com.

About Stemline Therapeutics

Surface Oncology Reports Financial Results and Corporate Highlights for Second Quarter 2018

On August 14, 2018 Surface Oncology (NASDAQ:SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported financial results and corporate highlights for the second quarter of 2018 (Press release, Surface Oncology, AUG 14, 2018, View Source [SID1234528881]).

"Since the completion of our IPO, we have made significant progress across the company, including continued progress of our SRF231 Phase I trial, with initial data expected in the first half of 2019, and the advancement of a second program, NZV930, into clinical development by our partner, Novartis. The speed with which these programs have advanced from discovery to clinical stage is truly remarkable, and I congratulate the entire team on a job well done," said Jeff Goater, chief executive officer of Surface Oncology. "We remain focused on execution in all aspects of the company, including IND-enabling studies for our SRF617 and SRF388 programs."

Selected Highlights:

SRF231, a fully human monoclonal antibody targeting CD47: In February 2018, Surface initiated a Phase I trial of SRF231. The multi-center, open-label Phase I trial will evaluate the safety and tolerability of SRF231 in multiple ascending doses with the goal of establishing a recommended dose for further study. Following the dose escalation phase, the Company intends to evaluate the safety and efficacy of SRF231 in a targeted set of solid and hematologic malignancies. The trial plan calls for enrollment of up to ~150 patients with initial clinical results from this trial expected in the first half of 2019. Surface holds worldwide rights to SRF231. In July, the FDA granted SRF231 Orphan Drug Designation for the treatment of multiple myeloma.

NZV930 (formerly SRF373), a fully human monoclonal antibody targeting CD73: Surface’s collaborator, Novartis, initiated a Phase I clinical trial for NZV930 in June 2018. The study will assess the safety, tolerability, and preliminary anti-tumor activity of NZV930 alone and when combined with PDR001 (anti-PD-1) and/or NIR178 (A2AR antagonist), in patients with advanced cancers. The trial is designed to enroll up to 344 patients across multiple solid tumor indications, including non-small cell lung cancer, triple negative breast cancer, pancreatic ductal adenocarcinoma, microsatellite stable colorectal cancer, ovarian cancer and renal cell carcinoma. NZV930 has been licensed on a worldwide basis by Novartis.

In June, Surface Oncology was recognized as one of the Best Places to Work in 2018 by the Boston Business Journal.

In July, Liisa Nogelo-Kerr joined Surface as General Counsel. She brings nearly 20 years of corporate, transactional, R&D and commercial legal experience in the biotechnology industry. Prior to Surface, Liisa served as the General Counsel of the Broad Institute of MIT and Harvard. In this role, she was responsible for the Broad’s legal operations, including support of research initiatives and the negotiation of major transactions with pharma and tech companies. Prior to the Broad Institute, Liisa held senior positions on the R&D and corporate legal teams at Biogen and served as lead attorney and member of the executive committee for three late-stage drug development programs in ALS and hemophilia. Earlier in her career, Liisa practiced at Bingham McCutchen, an international law firm, where she advised private equity, medical device, biotechnology and other emerging technology company clients on a broad range of corporate and transactional matters.

Also in July, Seth Lewis joined Surface as Vice President, Investor Relations and Corporate Communications. Most recently Seth was Vice President, Investor Relations and Corporate Communications at Bavarian Nordic, an international biotech focused on live virus vaccine R&D and manufacturing. Prior to his time at Bavarian Nordic, Seth was a Senior Vice President of The Trout Group, LLC, a leading investor relations and advisory firm, focused on life sciences companies.
Financial Results
As of June 30, 2018, cash, cash equivalents and marketable securities were $185.6 million, compared to $63.3 million on December 31, 2017. This increase was primarily related to $108.7 million in net proceeds from the Company’s IPO and concurrent private placement completed in April 2018.

Research and development (R&D) expenses were $15.1 million for the second quarter ended June 30, 2018, compared to $10.7 million for the same period in 2017. The increase was largely due to expenditures associated with Surface’s advancing product pipeline, including increased R&D personnel costs associated with the growth of the Company. R&D expenses included $0.8 million in stock-based compensation expenses for the second quarter of 2018.

General and administrative (G&A) expenses were $3.9 million for the second quarter ended June 30, 2018, compared to $2.0 million for the same period in 2017. The increase was largely due to increased G&A personnel associated with the growth of the company and increased professional fees. G&A expenses included $0.7 million in stock-based compensation expenses for the second quarter of 2018.

For the second quarter ended June 30, 2018, net loss was $15.9 million, or basic and diluted net loss per share attributable to common stockholders of $0.73. Net loss was $6.6 million for the same period in 2017, or basic and diluted net loss per share attributable to common stockholders of $2.73. The decrease in net loss per share attributable to common shareholders is primarily due to the completion of the IPO in April 2018, which resulted in the sale of 7,200,000 shares of common stock and automatic conversion of 16,863,624 shares of convertible preferred stock into shares of common stock. In addition to the shares sold in the public offering, the Company completed a concurrent sale of an additional 766,666 shares at the initial offering price of $15.00 per share.

Cautionary Note Regarding Forward-Looking Statements:
Certain statements set forth in this press release constitute "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements can be identified by terms such as "believes," "expects," "plans," "potential," "would" or similar expressions and the negative of those terms. These forward-looking statements are based on our management’s current beliefs and assumptions about future events and on information currently available to management.

Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks include, but are not limited to, risks and uncertainties related to: our limited operating history and historical losses, our liquidity to fund the development of SRF231 and our other product candidates through current and future milestones, our ability to raise additional funding to complete the development and any commercialization of our product candidates, our dependence on the success of our lead product candidates, SRF231 and NZV930, results from preclinical studies or early clinical trials may not be representative of larger clinical trials, results from the clinical trials and preclinical studies of third parties working in immuno-oncology and our dependence on third parties in connection with our manufacturing, clinical trials and pre-clinical studies. Additional risks and uncertainties that could affect our future results are included in the section titled "Risk Factors" and "Management’s Discussion and Analysis of Financial Condition and Results of Operations" in our Prospectus dated April 18, 2018, which is available on the SEC’s website at www.sec.gov and our website at www.surfaceoncology.com. Additional information on potential risks will be made available in other filings that we make from time to time with the SEC. In addition, any forward-looking statements contained in this press release are based on assumptions that we believe to be reasonable as of this date. Except as required by law, we assume no obligation to update these forward-looking statements, or to update the reasons if actual results differ materially from those anticipated in the forward-looking statements.

GTx Provides Corporate Update and Reports Second Quarter 2018 Financial Results

On August 14, 2018 GTx, Inc. (Nasdaq:GTXI) reported financial results for the second quarter ended June 30, 2018 and highlighted recent accomplishments and upcoming milestones (Press release, GTx, AUG 14, 2018, View Source;p=irol-newsArticle&ID=2363550 [SID1234528880]).

"During the second quarter, we achieved a key milestone for the company when we completed patient enrollment in our placebo-controlled, Phase 2 ASTRID Trial of enobosarm in postmenopausal women with stress urinary incontinence (SUI)," said Robert J. Wills, Ph.D., Executive Chairman of GTx. "Due to overwhelming interest from women wanting to participate in the clinical trial, we completed enrollment several months ahead of schedule and exceeded the 400 patients planned. We look forward to reporting 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. Recent and upcoming important milestones are summarized as follows:

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.
On May 18, 2018, a podium presentation entitled "Oral Enobosarm Shows Promising Activity in Post-Menopausal Women with Stress Urinary Incontinence: Results of a Phase 2 Study," took place at the 2018 American Urological Association (AUA) annual meeting. The presentation updated results from the Phase 2 POC clinical trial of enobosarm. Details of the AUA presentation can be found here and are summarized below:
At the end of the 12-week treatment period, all 18 enobosarm-treated women showed 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.
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.
The ASTRID Trial protocol includes a four-month, off-drug durability assessment in the first 225 patients enrolled. These data will be announced simultaneously with the ASTRID results. Once the 225-patient cohort completes the four-month, off-drug durability assessment, those patients will have, at their discretion, the option to enter an additional five-month, off-drug extension study to provide a total of nine months of off-drug durability assessment.
The Company also has initiated an open-label safety extension study. Each participating patient will receive 3 mg of oral enobosarm on a daily basis.
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.

Second Quarter 2018 Financial Results

As of June 30, 2018, cash and short-term investments were $45.7 million compared to $43.9 million at December 31, 2017.
Research and development expenses for the quarter ended June 30, 2018 were $8.0 million compared to $4.4 million for the same period of 2017.
General and administrative expenses for the quarter ended June 30, 2018 were $2.2 million compared to $2.0 million for the same period of 2017.
The net loss for the quarter ended June 30, 2018 was $10.0 million compared to a net loss of $6.4 million for the same period in 2017.
Net loss for the six months ended June 30, 2018 was $23.6 million compared to a net loss of $12.7 million for the same period in 2017.
GTx had approximately 24.0 million shares of common stock outstanding as of June 30, 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 that was 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) 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 27 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.