On August 14, 2018 Sophiris Bio Inc. (NASDAQ: SPHS) (the "Company" or "Sophiris"), a biopharmaceutical company studying topsalysin (PRX302), a first-in-class, pore-forming protein, in late stage clinical trials for the treatment of patients with urological diseases, reported financial results for the second quarter 2018 and recent corporate highlights (Press release, Sophiris Bio, AUG 14, 2018, View Source [SID1234528933]).

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"In the second quarter, we announced top-line interim safety and biopsy data following a single administration of topsalysin from our ongoing Phase 2b clinical trial in low to intermediate risk localized prostate cancer," said Randall E. Woods, president and CEO of Sophiris. "The 29% (10/35 patients) clinical response rate we observed was extremely encouraging and provides the foundation for the next stage of development. We and our scientific advisors believe the initial data support advancing topsalysin for the treatment of localized prostate cancer into potential registration trials, and we will continue to evaluate the merits of administering a second dose. Looking ahead for the rest of the year, we are continuing our manufacturing activities to ensure drug supply for potential Phase 3 trials, we plan to advance dialogue with the regulatory agencies around a potential Phase 3 trial design in patients with localized prostate cancer and, once available, we will evaluate safety and biopsy data from the patients who received a second administration of topsalysin."

Second Quarter Corporate Highlights:

Positive top-line interim results from Phase 2b trial in localized prostate cancer. On June 25, the Company announced top-line safety and six month follow-up biopsy data from 35 patients with pre-identified, clinically-significant localized prostate cancer that were treated with a single administration of topsalysin.

Safety analysis, following a single administration of topsalysin in this study indicates that, to date, topsalysin has been well-tolerated; no hypersensitivity reactions or other serious systemic reactions to study medication have been observed after a single administration.

Based on the six-month follow-up biopsy results, 29% of patients (10/35) demonstrated a clinical response. Of the 10 clinical responders in the Phase 2b trial, six patients experienced a complete ablation with no histological evidence of the targeted tumor remaining. In addition, 37% of patients (13/35) experienced a partial response, but the targeted lesion was still deemed clinically-significant based on the targeted biopsy.

Two additional patients have received six-month follow-up biopsies following their first administration of topsalysin. The Company expects to report updated data following receipt of the results of these biopsies.

Independent Data Monitoring Committee recommendation to continue clinical trial as planned. In May 2018, an Independent Data Monitoring Committee (IDMC) met to review the safety data from all 38 patients administered a single dose of topsalysin as well the safety data available from the first seven patients who received a second administration of topsalysin. At that time, the IDMC unanimously recommended the clinical trial continue without changes to the protocol.

Second administration completed in Phase 2b trial. The Phase 2b study was designed to include an option to re-treat patients who did not have any clinically-significant adverse events and who responded to the first administration of topsalysin but still had a targeted lesion remaining.

Eleven patients received a second administration of topsalysin in the Phase 2b clinical trial. The eleventh patient died on the same day he received a second administration of topsalysin. The death did not occur during the procedure. As a precaution, Sophiris elected to halt further re-administration and no additional patients have received a second administration of topsalysin in the Phase 2b clinical trial. The event is under active review.

The Company expects to have six month follow-up biopsy results and additional safety data from all patients who received a second administration of topsalysin in its ongoing Phase 2b trial in localized prostate cancer patients late in the fourth quarter of 2018.

Financial Results:

At June 30, 2018, the Company had cash, cash equivalents and securities available-for-sale of $18.5 million and working capital of $14.1 million. The Company expects that its cash and cash equivalents will be sufficient to fund its operations through June 2019, assuming no new clinical trials are initiated. The Company will require significant additional funding to advance topsalysin in clinical development. As of June 30, 2018, the outstanding principal balance of our term loan was $7 million on which the Company is currently making monthly interest only payments.

For the three months ended June 30, 2018

The Company reported a net loss of $6.1 million or ($0.20) per share for the three months ended June 30, 2018, compared to net income of $0.6 million or $0.02 per share for the three months ended June 30, 2017. The net income for the three months ended June 30, 2017 was driven by a non-cash gain related to the revaluation of the Company’s warrant liability. See an additional discussion below related to this item.

Research and development expenses

Research and development expenses were $3.6 million for the three months ended June 30, 2018, compared to $1.4 million for the three months ended June 30, 2017. The increase in research and development costs is primarily attributable to increases in the costs associated with manufacturing activities for topsalysin, and to a lesser extent, an increase in clinical costs associated with our Phase 2b clinical trial of topsalysin for the treatment of localized prostate cancer.

General and administrative expenses

General and administrative expenses were $1.1 million for the three months ended June 30, 2018, compared to $1.4 million for the three months ended June 30, 2017. The decrease in general and administrative expense is primarily due to decreases in non-cash stock-based compensation expense and consulting services.

Gain (loss) on revaluation of the warrant liability

Loss on revaluation of the warrant liability was $1.4 million for the three months ended June 30, 2018, compared to a gain of $3.3 million for the three months ended June 30, 2017. As these warrants may require the Company to pay the warrant holder cash under certain provisions of the warrant, the Company accounts for these warrants as a liability, and the Company is required to calculate the fair value of these warrants each reporting date. The non-cash loss reported for the three months ended June 30, 2018, is associated with a increase in the fair value of the Company’s warrant liability from March 31, 2018, to June 30, 2018, which is calculated using a Black-Scholes pricing model. Certain inputs utilized in the Company’s Black-Scholes fair value calculation may fluctuate in future periods based upon factors which are outside of the Company’s control. A significant change in one or more of these inputs used in the calculation of the fair value may cause a significant change to the fair value of the Company’s warrant liability, which could also result in a material non-cash gain or loss being reported in the Company’s consolidated statement of operations and comprehensive loss.

For the six months ended June 30, 2018

The Company reported a net loss of $9.4 million or ($0.31) per share for the six months ended June 30, 2018 compared to a net loss of $2.0 million or ($0.07) per share for the six months ended June 30, 2017.

Research and development expenses

Research and development expenses were $6.9 million for the six months ended June 30, 2018 compared to $2.6 million for the six months ended June 30, 2017. The increase in research and development costs is primarily attributable to increases in the costs associated with manufacturing activities for topsalysin, and to a lesser extent, an increase in clinical costs associated with our Phase 2b clinical trial of topsalysin for the treatment of localized prostate cancer.

General and administrative expenses

General and administrative expenses were $2.3 million for the six months ended June 30, 2018 compared to $2.7 million for the six months ended June 30, 2017. The decrease in general and administrative expense is primarily due to decreases in non-cash stock-based compensation expense and consulting services.

Gain (loss) on revaluation of the warrant liability

Loss on revaluation of the warrant liability was $10 thousand for the six months ended June 30, 2018 as compared to a gain of $3.2 million for the six months ended June 30, 2017. The non-cash loss reported for the six months ended June 30, 2018, is associated with an increase in the fair value of our warrant liability from December 31, 2017 to June 30, 2018.

On August 14, 2018 Agilent Technologies, Inc. (NYSE: A) reported revenue of $1.20 billion for the third quarter ended July 31, 2018, up 8 percent year over year (up 6 percent on a core basis(1)) (Press release, Agilent, AUG 14, 2018, http://www.agilent.com/about/newsroom/presrel/2018/14aug-gp18051.html [SID1234529003]).

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Third-quarter GAAP net income was $236 million, or $0.73 per share. Last year’s third-quarter GAAP net income was $175 million, or $0.54 per share.

During the third quarter, Agilent had intangible amortization of $26 million, acquisition and integration costs of $7 million, transformational initiatives of $4 million, business exit and divestitures of $1 million, $20 million of step-up gain on our initial Lasergen investment, and $5 million in other costs. Excluding these items and a tax benefit of $42 million, Agilent reported third-quarter non-GAAP net income of $217 million, or $0.67 per share(2), up 14 percent year over year.

"The Agilent team continues to capitalize on healthy end markets and delivered another strong quarter," said Mike McMullen, Agilent CEO and president. "Both earnings and revenue growth, led by China and the global pharma and chemical & energy end markets, exceeded expectations. In addition, we achieved our 14th consecutive quarter of improving our year-over-year core operating margins."

"We put our strong balance sheet to work creating value for shareholders and customers," McMullen continued. "We repurchased $243 million in shares, paid $48 million in dividends, and invested $430 million in M&A."

Financial Highlights

Third-quarter revenue of $540 million from Agilent’s Life Sciences and Applied Markets Group (LSAG) grew 6 percent year over year (up 5 percent on a core basis(1)) with strength in the chemical & energy and pharma end markets. LSAG’s operating margin for the quarter was 22.9 percent.

Third-quarter revenue of $426 million from the Agilent CrossLab Group (ACG) grew 10 percent year over year (up 8 percent on a core basis(1)). Both services and consumables saw strong growth across all end markets and geographies. ACG’s operating margin for the quarter was 23.8 percent.

Third-quarter revenue of $237 million from Agilent’s Diagnostics and Genomics Group (DGG) grew 9 percent year over year (up 5 percent on a core basis(1)). Strength in genomics and China led the results. DGG’s operating margin for the quarter was 18.5 percent.

Agilent expects fourth-quarter 2018 revenue in the range of $1.24 billion to $1.26 billion. Fourth-quarter 2018 non-GAAP earnings are expected to be in the range of $0.72 to $0.74 per share(3).

For fiscal year 2018, Agilent expects revenue of $4.86 billion to $4.88 billion and non-GAAP earnings of $2.69 to $2.71 per share(3). The guidance is based on July 31, 2018 currency exchange rates.

Conference Call

Agilent’s management will present more details about its third-quarter fiscal 2018 financial results on a conference call with investors today at 1:30 p.m. (Pacific Time). This event will be webcast live in listen-only mode. Listeners may log on at www.investor.agilent.com and select "Q3 2018 Agilent Technologies Inc. Earnings Conference Call" in the "News & Events — Calendar of Events" section. The webcast will remain available on the company’s website for 90 days.

Additional information regarding financial results can be found at www.investor.agilent.com by selecting "Financial Results" in the "Financial Information" section.

A telephone replay of the conference call will be available at approximately August 14, 2018 at 4:30 PM (Pacific Time) after the call and through August 22 by dialing +1 855-859-2056 (or +1 404-537-3406 from outside the United States) and entering pass code 3179138.

The adjustment for taxes excludes tax benefits that management believes are not directly related to on-going operations and which are either isolated or cannot be expected to occur again with any regularity or predictability. For the three and nine months ended July 31, 2018, management uses a non-GAAP effective tax rate of 18.0%. In the same periods last year, management used a non-GAAP effective tax rate of 16.2% and 18.0%, respectively.
We provide non-GAAP net income and non-GAAP net income per share amounts in order to provide meaningful supplemental information regarding our operational performance and our prospects for the future. These supplemental measures exclude, among other things, charges related to amortization of intangibles, business exit and divestiture costs, transformational initiatives, acquisition and integration costs, pension settlement gain, gain on step acquisition of Lasergen, NASD site costs, special compliance costs, and adjustment for Tax Reform.
Business exit and divestiture costs include costs associated with business divestitures.
Transformational initiatives include expenses associated with targeted cost reduction activities such as manufacturing transfers including costs to move manufacturing due to new tariffs and tariff remediation actions, small site consolidations, legal entity and other business reorganizations, insourcing or outsourcing of activities. Such costs may include move and relocation costs, one-time termination benefits and other one-time reorganization costs. Included in this category are also expenses associated with company programs to transform our product lifecycle management (PLM) system, human resources and financial systems.
Acquisition and Integration costs include all incremental expenses incurred to effect a business combination. Such acquisition costs may include advisory, legal, accounting, valuation, and other professional or consulting fees. Such integration costs may include expenses directly related to integration of business and facility operations, the transfer of assets and intellectual property, information technology systems and infrastructure and other employee-related costs.
Pension settlement gain resulted from transfer of the substitutional portion of our Japanese pension plan to the government.
Gain on step acquisition of Lasergen resulted from the measurement at fair value of our equity interest held at the date of business combination.
NASD site costs include all the costs related to the expansion of our manufacturing of nucleic acid active pharmaceutical ingredients incurred prior to the commencement of commercial manufacturing.
Special compliance costs include costs associated with transforming our processes to implement new regulations such as the EU’s General Data Protection Regulation (GDPR), revenue recognition and certain tax reporting requirements.
Other includes certain legal costs and settlements in addition to other miscellaneous adjustments.
Adjustment for Tax Reform primarily consists of an estimated provision of $480 million for U.S. transition tax and correlative items on deemed repatriated earnings of non-U.S. subsidiaries and an estimated provision of $53 million associated with the decrease in the U.S. corporate tax rate from 35% to 21% and its impact on our U.S. deferred tax assets and liabilities. The taxes payable associated with the transition tax, net of tax attributes, on deemed repatriation of foreign earnings is approximately $440 million, payable over 8 years. The final impact of Tax Reform may differ materially from these estimates, due to, among other things, changes in interpretations, analysis and assumptions made, additional guidance that may be issued, and actions that we may undertake.
Our management uses non-GAAP measures to evaluate the performance of our core businesses, to estimate future core performance and to compensate employees. Since management finds this measure to be useful, we believe that our investors benefit from seeing our results "through the eyes" of management in addition to seeing our GAAP results. This information facilitates our management’s internal comparisons to our historical operating results as well as to the operating results of our competitors.
Our management recognizes that items such as amortization of intangibles can have a material impact on our cash flows and/or our net income. Our GAAP financial statements including our statement of cash flows portray those effects. Although we believe it is useful for investors to see core performance free of special items, investors should understand that the excluded items are actual expenses that may impact the cash available to us for other uses. To gain a complete picture of all effects on the company’s profit and loss from any and all events, management does (and investors should) rely upon the GAAP income statement. The non-GAAP numbers focus instead upon the core business of the company, which is only a subset, albeit a critical one, of the company’s performance.
Readers are reminded that non-GAAP numbers are merely a supplement to, and not a replacement for, GAAP financial measures. They should be read in conjunction with the GAAP financial measures. It should be noted as well that our non-GAAP information may be different from the non-GAAP information provided by other companies.
The preliminary non-GAAP net income and diluted EPS reconciliation is estimated based on our current information.

We compare the year-over-year change in revenue excluding the effect of recent acquisitions and divestitures and foreign currency rate fluctuations to assess the performance of our underlying business.
(a) The constant currency year-over-year growth percentage is calculated by recalculating all periods in the comparison period at the foreign currency exchange rates used for accounting during the last month of the current quarter, and then using those revised values to calculate the year-over-year percentage change.
(b) The dollar impact from the current quarter currency impact is equal to the total year-over-year dollar change less the constant currency year-over-year change.
The preliminary reconciliation of GAAP revenue adjusted for recent acquisitions and divestitures and impact of currency is estimated based on our current information.

On August 14, 2018 Cleveland BioLabs, Inc. (NASDAQ:CBLI) reported financial results and development progress for the second quarter ended June 30, 2018 (Press release, Cleveland BioLabs, AUG 14, 2018, View Source [SID1234529749]).

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Cleveland BioLabs reported a net loss of $(0.85) million, excluding minority interests, for the second quarter of 2018, or $(0.08) per share, compared to a net loss, excluding minority interests, of $(5.6) million, or $(0.50) per share, for the same period in 2017. The decrease in net loss was primarily due to a decrease in the non-cash adjustment to our warrant liabilities, increased revenues, and reduced operating costs aligned with our streamlined focus primarily on pursuing a pre Emergency Use Authorization with the U.S. Food and Drug Administration ("FDA") and a Marketing Authorization Application with the European Medicines Agency ("EMA") for entolimod as a medical radiation countermeasure.

As of June 30, 2018, the Company had $6.5 million in cash, cash equivalents and short-term investments, which, based on the Company’s current operational plan, is expected to fund operations for at least one year beyond the filing date of our Form 10-Q.

Yakov Kogan, Ph.D., MBA, Chief Executive Officer, stated, "The pursuit of regulatory approval and commercialization for entolimod as a medical radiation countermeasure remains our top priority."

Further Financial Results

Revenue for the second quarter of 2018 increased to $0.4 million compared to $0.2 million for the second quarter of 2017. The net increase was primarily attributable to increased revenue from our service contract with Incuron and increased revenue from our Joint Warfighter Medical Research Program ("JWMRP") contract from the Department of Defense ("DoD") for the continued development of the entolimod as a medical radiation countermeasure.

Research and development costs for the second quarter of 2018 decreased to $0.9 million compared to $1.2 million for the second quarter of 2017. The reduction in research and development costs is due to a $0.6 million reduction in spending for biodefense applications of entolimod partially offset by a $0.3 million increase in expenses related to the oncology applications of the entolimod family of compounds.

General and administrative costs for the second quarter of 2018 decreased to $0.55 million compared to $0.59 million for the second 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.

On August 14, 2018 Onconova Therapeutics, Inc. (NASDAQ: ONTX), a Phase 3 stage biopharmaceutical company focused on developing rigosertib, a novel small molecule drug candidate to treat cancer, with a primary focus on Myelodysplastic Syndromes (MDS), reported financial results for the second quarter of 2018, ended June 30, 2018 (Press release, Onconova, AUG 14, 2018, View Source [SID1234528879]). The Company ended the second quarter with $29.5 million in cash and cash equivalents, which included proceeds from an underwritten public offering completed in this quarter.

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"We are pleased to have completed our public offering in May, which included new fundamental institutional biotech investors and broadened our shareholder base," commented Dr. Ramesh Kumar, Chief Executive Officer. "Combined with the financing we completed earlier this year and a licensing agreement in Latin America with Pint Pharma, we have significantly strengthened our balance sheet, providing a pathway to reaching anticipated key milestones in 2018 and 2019."

Steven M. Fruchtman, M.D., President, stated, "During the second quarter of 2018, we continued to make progress in our rigosertib clinical programs, including our IV rigosertib Phase 3 INSPIRE trial for 2nd-line higher-risk (HR) MDS patients. For this trial, we have opened new sites in countries already participating and added another country. We expect to complete the INSPIRE trial in the second half of 2019. After full enrollment of the Phase 2 oral rigosertib trial in combination with azacitidine in patients with either 1st-line HR-MDS or those with azacitidine-resistant disease, we are continuing to collect safety and efficacy data from this study. The combination trial with azacitidine is expected to advance to a pivotal Phase 3 trial for 1st-line HR-MDS patients in 2019, pending funding."

Upcoming Milestones (H2-2018 and 2019)

Top-line data for the pivotal Phase 3 INSPIRE study, which will be available after 288 death events. Total enrollment is expected to be 360 randomized patients
Presentation of updated efficacy and safety data from rigosertib/azacitidine combination Phase 2 studies in MDS at a medical meeting
Regulatory submissions for the Phase 3 trial in MDS of the combination program
Advance of RASopathy collaborative program to the clinic funded by NCI CRADA
Investigator initiated studies for rigosertib indications beyond MDS
IND for Dual CDK 4/6 + ARK5 inhibitor ON 123300 (IND studies funded by HanX Biopharmaceuticals)
Second Quarter Highlights

In June, Steven M. Fruchtman, M.D., Chief Medical Officer and Senior Vice President, Research and Development, was promoted to President. During his three and a half year tenure, Dr. Fruchtman has been instrumental in advancing rigosertib to key data milestones. In his new role, Dr. Fruchtman is now providing leadership across the Company’s entire product portfolio.

In May, Onconova strengthened its balance sheet with the successful completion of a $28.75 million upsized underwritten public offering. This financing, combined with the $10.0 million offering completed in February 2018, enables the Company to advance its late-stage programs in MDS to key upcoming milestones; the start of the combination therapy pivotal studies in MDS will require additional funding and/or business development transactions.

ON 123300, a first-in-class dual inhibitor of CDK4/6 + ARK5 has potential applications in a variety of cancers and is advancing toward clinical development in partnership with HanX Biopharmaceuticals, our Greater China collaborator. Following pre-IND consultations with the U.S. Food and Drug Administration, HanX has commenced manufacturing and toxicology studies to support filing of an IND in the U.S.
Second Quarter 2018 Financial Results

Cash and cash equivalents at June 30, 2018, totaled $29.5 million, compared to $4.0 million at December 31, 2017. This includes the net proceeds from the $28.75 million financing completed in May 2018, including the exercise in full of the underwriter’s over-allotment option.

Net loss was $4.3 million for the second quarter ended June 30, 2018, compared to a net loss of $2.6 million for the second quarter ended June 30, 2017, primarily due to a $3.5 million gain on the change in warrant liability in the 2017 period compared to $0.5 million gain in the 2018 period. Research and development expenses were $4.1 million for the second quarter ended June 30, 2018, and $4.6 million for the comparable period in 2017. General and administrative expenses were $2.1 million for the second quarter ended June 30, 2018, and $1.8 million for comparable period in 2017.

Net loss was $9.4 million for the six months ended June 30, 2018, compared to a net loss of $10.9 million for the six months ended June 30, 2017, primarily due to $0.8 million of license fee revenue and $0.9 million less research and development expenses in the 2018 period.

The Company will host a conference call on Tuesday, August 14, at 9:00 a.m. Eastern Time to provide a corporate update and discuss second quarter 2018 financial results. Interested parties may access the call by dialing toll-free (855) 428-5741 from the U.S., or (210) 229-8823 internationally, and using conference ID: 5287175. The call will also be webcast live. Please click here to access the webcast. A replay will be available at this link until November 30, 2018.

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]).

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"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.