On May 15, 2019 Leap Therapeutics, Inc. (NASDAQ:LPTX), a biotechnology company developing targeted and immuno-oncology therapeutics, reported financial results for the first quarter ended March 31, 2019 (Press release, Leap Therapeutics, MAY 15, 2019, View Source [SID1234536337]).

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"In the first quarter, we presented important new data for both of our programs. DKN-01’s activity continues to be impressive in biomarker targeted patient populations, with single agent partial responses in patients with endometrial cancer. In addition, TRX518 achieved a first partial response as a monotherapy and as a combination therapy with gemcitabine," commented Christopher K. Mirabelli, Ph.D, President and Chief Executive Officer of Leap Therapeutics. "We are looking forward to presenting additional clinical data from both programs in the second half of the year."

Recent Developments

·DKN-01 in ESOPHAGOGASTRIC CANCER: Leap presented clinical data from its study evaluating DKN-01 in combination with KEYTRUDA (pembrolizumab) in patients with advanced esophagogastric cancer. The overall response rate and disease control rate has been higher in patients with higher DKK1 expression as measured by in situ hybridization RNAscope. Enrollment in this study is complete.

·DKN-01 in GYNECOLOGICAL CANCERS: At the Society for Gynecologic Oncology 50th Annual Meeting on Women’s Cancer, Leap presented an update on its clinical study evaluating DKN-01 as a monotherapy and in combination with paclitaxel in patients with advanced gynecological cancers. DKN-01 monotherapy has generated two partial responses in patients with endometrial cancer, and DKN-01 plus paclitaxel has generated a partial response in a patient with carcinosarcoma. An additional DKN-01 monotherapy patient was initially reported by the treating investigator to have experienced a partial response; however, further follow-up identified that the patient has a tumor reduction that does not meet the threshold for a partial response and remains on treatment with ongoing clinical benefit. Eighty-seven patients have been enrolled in the study, and enrollment is ongoing.

·DKN-01 in PROSTATE CANCER: The first patient has been enrolled in an investigator-initiated study of DKN-01 as a monotherapy and in combination with docetaxel in DKK1-positive metastatic prostate cancer patients.

·TRX518 MONOTHERAPY: A non-virally mediated hepatocellular cancer patient, who has been treated with single agent TRX518 for two years, achieved a partial response. With recent disease progression, this patient now continues on treatment for clinical benefit.

· TRX518 COMBINATION THERAPY: Leap presented data from its clinical trial evaluating TRX518 in combination with gemcitabine chemotherapy or in combination with KEYTRUDA or OPDIVO (nivolumab), with patients from each combination arm experiencing responses and durable stable disease. Eighteen patients have been enrolled in the TRX518/KEYTRUDA expansion cohort, and enrollment is ongoing.
Selected First Quarter 2019 Financial Results

Net loss was $8.6 million for the first quarter 2019, compared to $10.6 million for the same period in 2018. This decrease was primarily due to a non-cash charge based on the change in the fair value of the warrant liability in the first quarter 2018, offset by an increase in clinical development expense.

Research and development expenses were $6.8 million for the first quarter 2019, compared to $4.2 million for the same period in 2018. This increase was primarily due to an increase in clinical trial expenses associated with an increase in patient enrollment and an increase in consulting fees and payroll expenses, partially offset by a decrease in manufacturing costs related to clinical trial material.

General and administrative expenses were $2.0 million for the first quarter 2019, compared to $2.1 million for the same period in 2018. This decrease was primarily due to a decrease in compensation expense as a result of senior management not accepting the cash bonus awarded to them by the compensation committee, partially offset by an increase in stock-based compensation expense.

Cash, cash equivalents and marketable securities totaled $21.7 million at March 31, 2019. Research and development incentive receivables, current and long term, totaled approximately $0.9 million at March 31, 2019.

On May 15, 2019 Veru Inc. (NASDAQ: VERU) an oncology and urology biopharmaceutical company developing novel medicines for prostate cancer treatment and prostate cancer supportive care, reported its financial results for its fiscal 2019 second quarter ended March 31, 2019 (Press release, Veru, MAY 15, 2019, View Source [SID1234536336]).

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Business and Operational Highlights

VERU-111: Our oral, next-generation, first-in-class, alpha and beta antitubulin is being evaluated in men who have metastatic prostate cancer and whose disease is resistant to both castration and novel androgen blocking agents (abiraterone or enzalutamide). The open label Phase 1b clinical trial being conducted to determine the maximally tolerated dose is progressing. The open label Phase 2 clinical study is expected to commence in the Fall of 2019. Oral drugs for advanced prostate cancer, abiraterone and enzalutamide, had over $3 billion in U.S. annual sales in 2018 and $6 billion in 2018 global revenue. Men with metastatic castration resistant prostate cancer who have failed these novel androgen blocking agents is the population that VERU-111 is targeting which represents an estimated $4.5 billion annual global market.

Zuclomiphene Citrate: Enrollment of approximately 100 men in the Phase 2 clinical trial is progressing in approximately 17 clinical sites in the US. Top line results of the study are expected Summer 2019. Zuclomiphene Citrate is a novel, proprietary, oral, nonsteroidal, estrogen receptor agonist to treat hot flashes caused by androgen deprivation therapy, or hormone treatment for men with advanced prostate cancer. Based on an independent market analysis sponsored by the Company, the expected U.S. sales potential for zuclomiphene citrate is estimated to exceed $600 million annually.

TADFIN (Tadalafil and Finasteride Combination Tablet): As previously announced, the Company completed a successful bioavailability and bioequivalence clinical trial for TADFIN for benign prostatic hyperplasia. The Company filed patent applications that, if issued, would have an expiry of 2040. NDA submission expected late 2019 to early 2020 with anticipated approval in 2020. BPH is an established multi-billion-dollar market.

"The clinical development of our proprietary drug pipeline is advancing," said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru. "In clinical observations, VERU-111 appears to be well tolerated, with no documented complaints or evidence of neurotoxicity or neutropenia. Moreover, in a number of men whose PSA was rising prior to enrollment into the Phase 1b clinical trial, we are seeing some evidence of PSA stabilizations and reductions even at the lowest doses of VERU-111 being tested, which is a promising early indication of efficacy. As for our zuclomiphene citrate product, based on the blinded aggregate preliminary clinical data from our placebo-controlled trial, we can make the following general clinical observations: men are experiencing reductions in hot flashes; and as for safety, zuclomiphene citrate appears to be well tolerated."

Fiscal 2019 Second Quarter vs Fiscal 2018 Second Quarter Financial Results

Net revenues up 171% to $7.0 million from $2.6 million. Company reported FC2 sales growth in both its public sector and its US prescription channels;

Gross profit up 285% to $4.6 million, or 66% of net revenues, from $1.2 million, or 47% of net revenues;

FC2 US prescription channel net revenues up 753% to $2.6 million from $0.3 million;

FC2 public sector channel net revenues up 88% to $4.2 million from $2.3 million;

Financial results do not reflect the new tender orders that will be coming from South Africa. We expect new orders from South Africa to commence shipping during the third quarter of this fiscal year;

Commercial segment, which includes FC2, PREBOOST and drug commercialization costs, generated operating income of $3.2 million versus an operating loss of $163,000;

Operating loss significantly narrowed to $2.1 million from $4.7 million; and

Net loss was $4.0 million, or $0.06 per share, compared with $3.8 million, or $0.07 per share.

Fiscal 2019 Year-to-Date vs Fiscal 2018 Year-to-Date Financial Results

Net revenues up 159% to $13.3 million from $5.2 million;

Gross profit up 268% to $9.3 million, or 69% of net revenues, from $2.5 million, or 49% of net revenues;

Net revenue from the US prescription channel was up 1,000% to $5.0 million from $458,000 in the prior-year period;

Net revenue for the public sector channel was up 73% to $8.1 million from $4.7 million in the prior-year period;

Net revenue for PREBOOST/ Roman Swipes was $180,000 compared to $4,600 in the prior-year period; an increase of 3800%;

Operating loss down 74% to $3.1 million from $12.1 million (fiscal 2018 year to date included a $3.8 million loss for the settlement of Brazilian receivables); and

Net loss was $6.2 million, or $0.10 per share, compared with $8.1 million, or $0.15 per share.

"We have achieved strong operating results through the first two quarters of fiscal 2019," said Dr. Steiner. "Positive financial growth continued into our second quarter, with sequential quarterly increases to net revenues from both our FC2 US prescription and public sector channels. Growth of our US FC2 prescription channel is particularly noteworthy as it appears to be less reliant on traditional intermittent ordering patterns present in our FC2 public sector channel."

Financial Guidance

Management expects net revenues will grow to $29-32 million for the full year FY2019 which represents a 95% increase over the full year FY2018, and management expects gross margin will be approximately 66% in FY2019 compared to 55% in FY2018.

"Based on current cash on hand and expected cash from current sales forecasts, along with existing sources of capital, the Company does not anticipate the need for a new equity financing until at least fiscal 2021," said Dr. Steiner.

The Company does not expect to update the guidance for the full year fiscal 2019 provided above before the release announcing results for the next fiscal quarter. The Company notes that the statements of future performance made in this release, including the guidance for the full fiscal year 2019, are based upon current expectations and are subject to factors that could cause actual results to differ materially from those suggested here, including those factors set forth in the "Safe Harbor" Statement below.

Conference Call Event Details

Veru Inc. will host a conference call today at 8 a.m. ET to review the Company’s performance. Interested investors may access the call by dialing 800-341-1602 from the U.S. or 412-902-6706 from outside the U.S. and asking to be joined into the Veru Inc. call.

In addition, investors may access a replay of the conference call the same day beginning at approximately noon Eastern Time by dialing 877-344-7529 for US callers, or 412-317-0088 from outside the U.S., passcode 10130716. The replay will be available for one week, after which, the recording will be available via the Company’s website at View Source

On May 15, 2019 Sutro Biopharma, Inc. (NASDAQ: STRO), a clinical-stage drug discovery, development and manufacturing company focused on the application of precise protein engineering and rational design to create next-generation oncology therapeutics, reported its financial results for the quarter ended March 31, 2019 (Press release, Sutro Biopharma, MAY 15, 2019, View Source [SID1234536335]).

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"During the first quarter of 2019, we initiated a Phase 1 clinical trial for our second wholly-owned product candidate, STRO-002, for the treatment of ovarian and endometrial cancers. We will present initial safety data for STRO-001, for the treatment of multiple myeloma and non-Hodgkin lymphoma on June 15, 2019 at the EHA (Free EHA Whitepaper) Congress," said Bill Newell, Sutro’s Chief Executive Officer. "Further, the investigational new drug ("IND") clearance received by our partner Celgene for our BCMA ADC represents another significant moment for antibody drug conjugates ("ADCs") as important therapeutic modalities in fighting cancer.

Recent Business Highlights and Developments

STRO-001 Clinical Program

Potential first-in-class and best-in-class ADC directed against CD74, which is highly expressed in many B cell malignancies
Phase 1 dose-escalation, with dose expansion, clinical trial enrolling patients with multiple myeloma and non-Hodgkin lymphoma, with initial safety data to be presented at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress on June 15, 2019 and initial efficacy data expected by year end 2019
STRO-001 granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of multiple myeloma
STRO-002 Clinical Program

Potential best-in-class ADC directed against folate receptor-alpha, which is highly expressed in ovarian cancer
Phase 1 dose-escalation, with dose expansion, clinical trial enrolling women with advanced ovarian and endometrial cancers, with initial safety data expected by year end 2019

BCMA ADC Clinical Program and Celgene Collaboration

Third product candidate to originate from Sutro’s proprietary discovery and manufacturing platform to enter clinical development since early 2018

Existing pipeline bolstered with three bispecific assets from Sutro’s collaboration with Celgene, for which Sutro holds U.S. rights, targeting BCMA-CD3, PD1-LAG3 and PD1-TIM3.

Celgene receives FDA clearance on its IND application for an ADC targeting B-cell maturation antigen ("BCMA") for the treatment of multiple myeloma, for which product candidate Celgene has worldwide development and commercialization rights. Sutro is entitled to development and regulatory milestone payments and tiered royalties from Celgene for this BCMA ADC.

Under the Celgene collaboration, U.S. clinical development and commercialization rights to three collaboration programs (BCMA-CD3, PD1-LAG3 and PD1-TIM3) are now fully owned by Sutro, as Celgene elected not to pay the option fee to continue to have rights for these programs following IND clearance of the first collaboration program. For any products resulting from these three programs, Celgene will own ex-U.S. development and commercialization rights and will be obligated to pay Sutro development and regulatory milestone payments and tiered royalties.

Quarter 2019 Financial Highlights

Cash, Cash Equivalents and Marketable Securities

As of March 31, 2019, Sutro had cash, cash equivalents and marketable securities of $184.3 million.

Revenue

Revenue was $8.6 million for the quarter ended March 31, 2019, which included collaboration revenue from Celgene, Merck and EMD Serono. On January 1, 2019, Sutro adopted Accounting Standards Update No. 2014-09 Revenue from Contracts with Customers (Accounting Standards Codification Topic 606). For more information on the impact of the adoption of the new revenue standard, see "Notes to Unaudited Interim Condensed Financial Statements" contained in Part I, Item 1 of Sutro’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 15, 2019. Future collaboration revenue from Celgene, Merck and EMD Serono, and from any future collaboration partners, will fluctuate as a result of the amount and timing of revenue recognition of upfront, milestones and other collaboration agreement payments.

Operating Expenses

Total operating expenses for the quarter ended March 31, 2019, were $22.9 million compared with $17.5 million for the same period in 2018, including non-cash stock-based compensation of $2.3 million and $0.3 million, and depreciation and amortization expense of $1.1 million and $1.2 million, in the 2019 and 2018 quarters, respectively. Total operating expenses for the 2019 quarter were comprised of research and development expenses of $15.2 million and general and administrative expenses of $7.7 million, with both expense types expected to increase in 2019 as Sutro’s internal product candidates advance in clinical development and additional general and administrative expenses are incurred as a public company following its IPO that closed on October 1, 2018.

On May 15, 2019 ArQule, Inc. (Nasdaq: ARQL) reported that Dr. Marc Schegerin, Chief Financial Officer and Head of Strategy, will present at the 20th Annual B. Riley FBR Institutional Investor Conference on May 22, 2019 at 9:30 a.m. PT at the Beverly Hilton in Beverly Hills, CA (Press release, ArQule, MAY 15, 2019, View Source [SID1234536334]).

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The live webcast of the presentation will be available via the "Investors & Media" section of ArQule’s website, www.arqule.com, under "Events & Presentations." A replay of the webcast will be available shortly after the conclusion of the presentation.

On May 15, 2019 Eli Lilly and Company (NYSE: LLY) reported that it will participate in the Bank of America Merrill Lynch 2019 Health Care Conference on Wednesday, May 15, 2019 (Press release, Eli Lilly, MAY 15, 2019, View Source [SID1234536333]). Enrique Conterno, senior vice president of Lilly and president of Lilly Diabetes and Lilly USA, will participate in a fireside chat at 9:20 a.m. PDT (12:20 p.m. EDT).

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A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s Investor website at View Source A replay of the presentation will be available on this same website for approximately 90 days.