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Geron Starts Phase 3 Clinical Trial in Lower Risk Myelodysplastic Syndromes

On August 8, 2019 Geron Corporation (Nasdaq: GERN) reported the opening of patient screening and enrollment for the Phase 3 portion of IMerge to evaluate imetelstat, a first-in-class telomerase inhibitor, in lower risk myelodysplastic syndromes (MDS) (Press release, Geron, AUG 8, 2019, View Source [SID1234538391]).

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"The start of the Phase 3 portion of IMerge is a significant milestone for Geron and imetelstat," said John A. Scarlett, M.D., Chairman and Chief Executive Officer. "We are hopeful that the Phase 3 will confirm the encouraging results from the Phase 2 portion, and that imetelstat could become a much-needed treatment alternative for patients with lower risk MDS."

IMerge is a two-part Phase 2/3 clinical trial of imetelstat in transfusion dependent patients with lower risk MDS who are relapsed after or refractory to erythroid stimulating agents (ESAs). The Phase 3 portion is planned to enroll approximately 170 patients in a randomized, double-blind, placebo-controlled clinical trial to test the hypothesis that imetelstat improves the rate of red blood cell transfusion independence (TI). The trial is planned to be conducted at multiple medical centers globally, including North America, Europe, Middle East and Asia. The primary efficacy endpoint is 8-week TI rate, which is defined as the proportion of patients achieving transfusion independence during any consecutive eight weeks since entry into the trial. Key secondary endpoints include the rate of transfusion independence lasting at least 24 weeks, or 24-week TI rate, durability of transfusion independence and the amount and relative change in transfusions.

Many key aspects from the Phase 2 portion of IMerge remain the same for the Phase 3 portion. A target patient population of non-del(5q) lower risk MDS patients who are naïve to treatment with hypomethylating agents (HMAs) and lenalidomide was identified from the Phase 2 portion, and will be enrolled in the Phase 3. In addition, the primary and secondary endpoints, the dose and schedule of imetelstat administration and many of the clinical sites remain the same as in the Phase 2. Recently reported Phase 2 data highlighted the meaningful and durable transfusion independence, disease-modifying activity, and efficacy responses across MDS patient subgroups potentially achievable with imetelstat treatment.

Based upon current planning assumptions, Geron expects top-line results for the IMerge Phase 3 trial to be available by mid-year 2022.

To learn more about IMerge and whether the study is enrolling patients in your area, please visit www.clinicaltrials.gov.

About Myelodysplastic Syndromes

Myelodysplastic syndromes are a group of diverse blood disorders that develop because bone marrow cells do not mature into healthy blood cells. Many patients develop chronic anemia, the predominant clinical problem in lower risk MDS, and become dependent on red blood cell transfusions. There are approximately 60,000 people living with the disease in the United States.

About Imetelstat

Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic myeloid malignancies. Early clinical data suggest imetelstat may have disease-modifying activity through the suppression of malignant progenitor cell clone proliferation, which allows potential recovery of normal hematopoiesis. Ongoing clinical studies of imetelstat consist of IMerge, a Phase 2/3 trial in lower risk myelodysplastic syndromes (MDS) and IMbark, a Phase 2 trial in Intermediate-2 or High-risk myelofibrosis. Imetelstat has been granted Fast Track designation by the United States Food and Drug Administration for the treatment of patients with transfusion dependent anemia due to non-del(5q) lower risk MDS who are refractory or resistant to an erythroid stimulating agent.

Ziopharm Oncology Reports Second Quarter 2019 Financial Results

On August 8, 2019 Ziopharm Oncology, Inc. ("Ziopharm" or the "Company") (Nasdaq: ZIOP), a clinical stage immuno-oncology company developing next generation cell and gene therapies, reported its financial results for the second quarter ended June 30, 2019, and provided an update on the Company’s recent activities (Press release, Ziopharm, AUG 8, 2019, View Source [SID1234538390]).

"We have made significant advancements in our programs during the second quarter. The FDA cleared the IND for the first non-viral, neoantigen-specific TCR-T cell therapy at the NCI using our Sleeping Beauty system and we announced an exclusive license to an expansive library of TCRs against neoantigens in three of the most important hotspot families," said Laurence Cooper, M.D., Ph.D., Chief Executive Officer of Ziopharm. "In our Controlled IL-12 program, we completed enrollment of the third dosing cohort in our phase 1 combination trial with nivolumab and initiated a phase 2 combination trial with Regeneron’s Libtayo. Finally, we refined our plans for the third-generation Sleeping Beauty CD19-specific CAR-T phase 1 trial at MD Anderson Cancer Center, which we continue to expect to commence later this year."

David Mauney, M.D., President of Ziopharm, added, "As our clinical programs continue to advance, we have strengthened our balance sheet and expanded the breadth and depth of our corporate leadership. We are proud to welcome Sath Shukla and Dr. Drew Deniger to our leadership team and Heidi Hagen to our Board of Directors. We are grateful that through the support of key shareholders who exercised their existing warrants several years prior to expiration, we added $45 million to our treasury to provide us with cash into the first half of 2021, which we expect will allow us to see data readouts in the three programs."

Corporate Updates

Since the beginning of the second quarter, Ziopharm has announced positive corporate developments regarding expansion of the management team and strengthening of the company’s balance sheet.

Balance sheet strengthened with $45 million: A group of Ziopharm shareholders, led by MSD Partners, L.P., exercised their existing warrants to purchase common stock, which resulted in gross proceeds of approximately $45 million. We expect this additional capital is sufficient to fund operations into 2021 and provide visibility into important clinical data milestones for Ziopharm’s TCR-T, CAR-T and Controlled IL-12 programs.

Sath Shukla named CFO: With 20 years of strategic corporate and financial leadership experience, Mr. Shukla joins as Chief Financial Officer from Vertex Pharmaceuticals, where he was most recently Vice President and global Head of Corporate Finance, directing financial planning, analysis and budgeting, and leading the annual long-range planning process encompassing Vertex’s entire portfolio and operations across more than 30 countries.

NCI’s Dr. Drew Deniger to Direct TCR-T Cell Therapy Program: In early July, Ziopharm announced that Dr. Deniger was hired from the NCI to lead Ziopharm’s non-viral T-cell program targeting neoantigens for personalized immunotherapy of solid tumors. Dr. Deniger worked under Dr. Steven Rosenberg at the NCI and is a recognized leader in the identification of TCRs targeting neoantigens. Dr. Deniger has a track record of helping to advance innovative immunotherapy approaches into the clinic and has years of expertise with the Sleeping Beauty system.

Heidi Hagen joins Board of Directors: In June, Ziopharm appointed Heidi Hagen, an experienced and entrepreneurial biotechnology operations executive, to the Company’s board of directors. The addition of Ms. Hagen represented the fifth new board member for Ziopharm in the past year.

Program Updates

Sleeping Beauty TCR-T Therapies

The Company is using its non-viral gene transfer technology to implement personalized T-cell therapy targeting solid tumors with TCRs. Under a Cooperative Research and Development Agreement (CRADA), the NCI is initiating a clinical trial to treat patients with metastatic/advanced solid tumors using the Company’s Sleeping Beauty transposon/transposase platform to genetically modify patient-derived T cells with TCRs to target patient-specific neoantigens.

FDA Clearance of IND for Sleeping Beauty TCR-T cell therapy: In June, Ziopharm announced that the investigational new drug (IND) application submitted by the NCI had received clearance from the U.S. Food and Drug Administration (FDA) for a clinical trial in solid tumors to evaluate TCR T-cell therapy utilizing Ziopharm’s Sleeping Beauty platform. Under the direction of Steven Rosenberg, M.D., Ph.D., Chief of the Surgery Branch at the NCI, and his team, the site is completing the internal processes for enrollment, while working to detect neoantigens to be targeted, isolating the TCRs and identifying patients for the trial.

Exclusive License with NCI to Identify and Use TCRs Targeting Neoantigens for Cancer with Sleeping Beauty Platform: In May, Ziopharm announced an exclusive license agreement with NCI for intellectual property for the development and commercialization of cell therapies for cancer. The scope of the license includes a library of TCRs against neoantigens in hotspots including mutated KRAS, p53 and EGFR for use with transposons. The license also includes technologies to enhance manufacturing capabilities for clinical-grade T cells (referred to as TCR-T) through the Sleeping Beauty platform.

Sleeping Beauty CAR-T Therapies

Ziopharm is advancing the Sleeping Beauty platform for the rapid personalized manufacture (RPM) of CAR-T cells, co-expressing membrane-bound interleukin-15, or mbIL15, with a safety switch, enabling T cells to be infused within two days after genetic modification. This work on our third-generation Sleeping Beauty technology is undertaken in collaboration with MD Anderson Cancer Center in the United States and in Greater China through a joint venture, Eden BioCell.

Third-generation phase 1 trial for RPM of Sleeping Beauty CD19-specific CAR-T with mbIL15 expected to begin later this year: The Company anticipates beginning a phase 1 trial at MD Anderson Cancer Center in the second half of this year, leveraging the Company’s RPM to produce T cells in two days or less after gene transfer. The Company has prioritized a new clinical trial infusing donor-derived allogeneic RPM CAR-T in patients who relapse after bone marrow transplantation to complement its autologous efforts targeting CD19, thereby providing a suite of CAR-T technologies to address the continuum of patients with refractory CD19+ malignancies.

Eden BioCell to advance third-generation Sleeping Beauty CD19-specific CAR-T for Greater China: With TriArm Therapeutics, a Panacea Venture Healthcare backed company, Eden BioCell was formed as a joint venture to develop and commercialize Sleeping Beauty-generated CD19-specific CAR-T in Greater China using the RPM technology. Recruitment of staff and buildout of facilities is accelerating, and the Eden BioCell team has begun meetings with potential hospital sites and their clinical teams.

Controlled IL-12

Ziopharm is developing its Controlled IL-12 platform, or Ad-RTS-hIL-12 plus veledimex, to control the production of human interleukin 12 (hIL-12) which activates the immune system to recruit and sustain cancer-fighting T cells within solid tumors. Ziopharm is advancing Ad-RTS-hIL-12 plus veledimex for the treatment of recurrent glioblastoma multiforme (rGBM) as a monotherapy and in combination with immune checkpoint inhibitors.

Enrollment completed in third cohort of combination study with OPDIVO (nivolumab): Ziopharm announced in June that it had completed enrollment in three dosing cohorts in its phase 1 study of adult patients with rGBM to evaluate a single dose of Ad-RTS-hIL-12 plus daily veledimex in combination with OPDIVO, an immune checkpoint inhibitor against programmed death-1 (PD-1). Based on a favorable safety profile, investigators from this multi-center trial indicated interest in expanding the study and the Company now expects to enroll up to 12 additional patients at the highest dosing level.

Phase 2 combination trial with Regeneron’s Libtayo (cemiplimab-rwlc) initiated in June: The Company, in collaboration with Regeneron Pharmaceuticals, initiated a phase 2 trial to evaluate Ad-RTS-hIL-12 plus veledimex in combination with Regeneron’s PD-1 antibody Libtayo to treat patients with rGBM. Enrollment for this study has commenced, as the Company expects to enroll about 30 patients at approximately 10 sites.

Positive clinical data presented at 2019 ASCO (Free ASCO Whitepaper) Annual Meeting: New interim analyses of clinical data from two ongoing substudies in its Controlled IL-12 platform, both as monotherapy and in combination with OPDIVO, were presented at ASCO (Free ASCO Whitepaper) in June. Additional updates are expected later this year.

FDA grants Fast Track status to Controlled IL-12 program: Ziopharm announced in April that FDA granted Fast Track designation for its Controlled IL-12 program for the treatment of rGBM in adults.

Second Quarter 2019 Financial Results

Net loss applicable to the common shareholders for the second quarter of 2019 was $14.6 million, or $(0.09) per share, compared to a net loss of $17.5 million, or $(0.12) per share, for the second quarter of 2018. The change in net loss to common shareholders resulted primarily from the elimination of approximately $5.5 million of dividends to preferred shareholders caused by the forfeiture and return of all of the Company’s Series 1 preferred stock in October 2018, along with the changes in research and development expenses and general and administrative expenses noted below.

Research and development expenses were $10.0 million for the second quarter of 2019, compared to $7.5 million for the second quarter of 2018. The increase in research and development expenses for the three months ended June 30, 2019 is primarily due to milestone costs under our patent license agreement with the NCI and increased nonclinical research and development to support our Cell Therapy programs. For additional context, research and development expenses in the first quarter of 2019 were $9.5 million.

General and administrative expenses were $4.8 million for the second quarter of 2019, compared to $4.9 million for the second quarter of 2018. For additional context, general and administrative expenses in the first quarter of 2019 were $4.1 million.

The Company ended the quarter with unrestricted cash resources of approximately $43.6 million.

In addition, a prepayment of approximately $24.2 million remains for programs to be conducted by the Company at MD Anderson Cancer Center under the current Research and Development Agreement.

As announced on July 29, 2019, the company raised approximately $45 million through the exercise of existing warrants. The Company believes its current resources will be sufficient to fund its planned operations into the first half of 2021.

Conference Call and Webcast

The call can be accessed by dialing 1-844-309-0618 (U.S. and Canada) or 1-661-378-9465 (international). The passcode for the conference call is 8279471. To access the live webcast or the subsequent archived recording, visit the "Investors" section of the Ziopharm website at www.ziopharm.com. The webcast will be recorded and available for replay on the Company’s website for two weeks.

AVEO Reports Second Quarter 2019 Financial Results and Provides Business Update

On August 8, 2019 AVEO Oncology (NASDAQ: AVEO) reported financial results for the second quarter ended June 30, 2019 and provided a business update (Press release, AVEO, AUG 8, 2019, View Source [SID1234538389]).

"As we move toward reporting more mature interim overall survival (OS) results from our TIVO-3 study of tivozanib in advanced kidney cancer, AVEO continues to make meaningful clinical, regulatory and strategic progress across our pipeline," said Michael Bailey, president and chief executive officer of AVEO. "Notably, since the beginning of the second quarter, we presented encouraging data from ongoing clinical studies of ficlatuzumab, our HGF inhibitory antibody, closed a public offering in April, and saw the approval of FOTIVDA in New Zealand. In addition to these events, we recently announced the amendment to our license agreement with Kyowa Kirin for tivozanib non-oncology rights, which is consistent with our strategy to develop and commercialize our oncology-focused pipeline while retaining meaningful economic interest and advancing our non-oncology pipeline through partnerships. As a result of the license amendment with Kyowa Kirin and the April financing, the Company’s cash runway is now anticipated to extend into the third quarter of 2021. We expect this progress will continue to build momentum as we look forward to the next interim OS readout from our TIVO-3 study in the fourth quarter of this year."

Recent Highlights

Announced Kyowa Kirin Buy Back of Tivozanib Non-Oncology Rights from AVEO. In August 2019, AVEO and Kyowa Kirin Co., Ltd. announced that the companies’ license agreement for tivozanib has been amended to allow Kyowa Kirin to buy back the non-oncology rights of tivozanib in AVEO’s territories, which includes the U.S. and EU. Under the terms of the amended license agreement, AVEO will receive a $25 million upfront payment and a waiver of the $18 million milestone payment due to Kyowa Kirin upon AVEO obtaining U.S. market approval for tivozanib. In addition, AVEO will be eligible to receive up to $391 million in milestone payments upon the successful achievement of certain development and commercial objectives related to tivozanib formulations for the treatment of non-oncology indications. AVEO is also eligible to receive tiered royalty payments on net sales in these indications, which range from a high single-digit to low double-digit percent.

FOTIVDA (tivozanib) Approval in New Zealand for the Treatment of Advanced RCC received by AVEO’s Partner, EUSA Pharma. In July 2019, the New Zealand Medicines and Medical Devices Safety Authority approved FOTIVDA (tivozanib) for the first line treatment of adult patients with advanced renal cell carcinoma (RCC) and for adult patients who are vascular endothelial growth factor receptor (VEGFR) and mTOR pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy for advanced RCC.

Presented Tivozanib Studies at the 2019 ASCO (Free ASCO Whitepaper) Annual Meeting. In June 2019, two tivozanib poster presentations reported encouraging data at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, Illinois. The presentations, titled "Efficacy and safety of tivozanib in recurrent, platinum-resistant ovarian, fallopian tube or primary peritoneal cancer" (abstract 361) and "TIVO-3: Subgroup analysis of progression-free survival of tivozanib compared to sorafenib in subjects with refractory advanced renal cell carcinoma (RCC)" (abstract 4572), are available in the Publications & Presentations section of AVEO’s website.

$2 Million Milestone Payment from EUSA Pharma Triggered. In April 2019, AVEO announced the triggering of a $2 million milestone payment from EUSA Pharma related to the reimbursement approval and commercial launch of FOTIVDA (tivozanib) in Spain as a first-line treatment of adult patients with RCC.

Closed Public Offering of Common Stock and Warrants. In April 2019, AVEO completed an underwritten public offering of 21,739,131 shares of common stock and warrants to purchase 25,000,000 shares of common stock at the public offering price of $1.14 per share and $0.01 per warrant. The warrants have a two-year term and a strike price of $1.25 per share. Gross proceeds of the offering were approximately $25.0 million and are expected to be used for clinical and preclinical development of AVEO’s product candidates, as well as for working capital and other general corporate purposes.

Announced Results from Phase 1b Ficlatuzumab-Cytarabine Trial (CyFi) in Patients with Relapsed and Refractory AML. In April 2019, AVEO announced the presentation of encouraging data from an investigator-sponsored Phase 1b expansion cohort of ficlatuzumab, AVEO’s potent hepatocyte growth factor (HGF) inhibitory antibody in combination with cytarabine in patients with relapsed and refractory acute myeloid leukemia (AML), at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, held March 29 – Apr 3, 2019 in Atlanta. Of 18 AML patients enrolled in the study, all had disease that was refractory to initial treatment, 17 were evaluable and 9 achieved a complete response. The most frequent grade 3/4 treatment emergent adverse events observed were febrile neutropenia, liver function test abnormalities, and electrolyte disturbance. There was one death from sepsis and multi-organ failure that was determined to be disease related, and one patient withdrew from the study due to grade 4 gastrointestinal bleed, determined to be likely ficlatuzumab related. A copy of the presentation is currently available in the Publications & Presentations section of AVEO’s website.

Based on these encouraging results, the Company is planning potential next steps for this program in collaboration with its ficlatuzumab development and commercialization partner, Biodesix, Inc.

Second Quarter 2019 Financial Results

AVEO ended Q2 2019 with $40.2 million in cash, cash equivalents and marketable securities as compared with $24.4 million at December 31, 2018.

Total revenue for Q2 2019 was approximately $0.7 million compared with $0.4 million for Q2 2018.

Research and development expense for Q2 2019 was $2.6 million compared with $4.9 million for Q2 2018.

General and administrative expense for Q2 2019 was $3.0 million compared with $2.8 million for Q2 2018.

Net loss for Q2 2019 was $3.1 million, or net loss of $0.02 per basic and diluted share, respectively, compared with net income of $4.0 million for Q2 2018, or income of $0.03 per basic share and a loss of $0.06 per diluted share.

Financial Guidance

AVEO believes that our approximate $40.2 million in cash, cash equivalents and marketable securities at June 30, 2019 together with the $25 million upfront payment from the Kyowa Kirin license amendment to be received in the third quarter would allow us to fund our planned operations into the third quarter of 2021. This estimate excludes, subject to our decision whether to submit an New Drug Application (NDA) for tivozanib to the U.S. Food and Drug Administration (FDA) following the availability of more mature OS results, remaining costs to prepare and filing fees in connection with a possible NDA submission, and pre-commercialization activities that we may undertake. This estimate also assumes no receipt of additional milestone payments from our partners, no funding from new partnership agreements, no additional equity financings, no debt financings, no additional sales of equity under our sales agreement with SVB Leerink and no additional sales of equity through the exercise of our outstanding warrants. Accordingly, the timing and nature of activities contemplated for the remainder of 2019 and thereafter will be conducted subject to the availability of sufficient financial resources.

About Tivozanib (FOTIVDA)

Tivozanib (FOTIVDA) is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) discovered by Kyowa Kirin and approved for the treatment of adult patients with advanced renal cell carcinoma (RCC) in the European Union plus Norway, New Zealand and Iceland. It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications.1,2 Tivozanib has been shown to significantly reduce regulatory T-cell production in preclinical models3 and has demonstrated synergy in combination with nivolumab (anti PD-1) in a Phase 2 study in RCC4. Tivozanib has been investigated in several tumor types, including renal cell, hepatocellular, ovarian, colorectal and breast cancers.

About Ficlatuzumab

Ficlatuzumab (formerly known as AV-299) is a potent hepatocyte growth factor (HGF) inhibitory antibody that binds to the HGF ligand with high affinity and specificity to inhibit HGF/c-Met biological activities. AVEO and Biodesix, Inc. have a worldwide agreement to develop and commercialize ficlatuzumab. Ficlatuzumab is currently being evaluated in investigator-sponsored trials in squamous cell carcinoma of the head and neck (SCCHN), metastatic pancreatic ductal cancer (PDAC) and acute myeloid leukemia (AML).

Veru Reports Higher Net Revenues and Gross Profit for its Fiscal 2019 Third Quarter

On August 8, 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 third quarter ended June 30, 2019 (Press release, Veru, AUG 8, 2019, View Source [SID1234538384]).

Business and Operational Highlights

VERU-111. VERU-111 is an oral, first-in-class, alpha and beta antitubulin being evaluated in a Phase 1b/2 clinical trial in men who have metastatic prostate cancer and whose disease is resistant to both castration and novel androgen blocking agents (abiraterone or enzalutamide). The objective of this clinical trial is to determine the dose limiting toxicity of VERU-111. At this point we have dosed 6 cohorts (18 men total) with escalating doses of VERU-111. In clinical observations, VERU-111 is well-tolerated with a favorable safety profile and no dose limiting toxicity has been observed. In some of the men whose PSA blood level was rapidly rising at enrollment, a marker of cancer progression, we have observed that VERU-111 treatment resulted in PSA stabilizations and reductions consistent with early promising signals of anticancer efficacy. Once we have reached a dose level that has dose limiting toxicity, we will be able to select the dose that will be evaluated in the Phase 2 clinical study. There are no drugs that are FDA approved to treat men who have both castration and novel androgen blocking agent resistant prostate cancer and which are also prechemotherapy (chemotherapy naïve), representing an estimated $4.5 billion annual global market.

Zuclomiphene Citrate. Zuclomiphene Citrate is a novel, proprietary, oral, nonsteroidal, estrogen receptor agonist being evaluated as a treatment for hot flashes caused by androgen deprivation therapy for men with advanced prostate cancer. Hot flashes are one of the main reasons why men want to stop androgen deprivation therapy. Approximately 100 men will be randomized in the Phase 2 clinical trial evaluating 2 doses (10mg and 50mg) of oral zuclomiphene versus placebo. Top line results expected late Summer/early Fall 2019. Based on an independent market analysis sponsored by the Company, expected U.S. sales potential for zuclomiphene citrate is estimated to exceed $600 million annually.

VERU-100. VERU-100 is a long-acting gonadotropin-releasing hormone (GnRH) antagonist for the treatment of hormone sensitive advanced prostate cancer. Currently, there are no GnRH antagonists commercially approved beyond 1 month, which would make VERU-100, if approved, the only commercially available GnRH antagonist 3-month depot. Recently, we added this proprietary internally developed peptide drug candidate to the Company’s late-stage drug development pipeline. Based on regulatory clarity obtained in the preIND meeting with FDA in May 2019, we plan to initiate a Phase 2 clinical study in early 2020 after GMP manufacturing of VERU-100. Androgen deprivation therapy for advanced prostate cancer is an established multi-billion-dollar global market.

TADFIN (Tadalafil and Finasteride Combination Capsule). TADFIN is being developed for BPH and would be the first combination of a PDE5 inhibitor and 5 alpha reductase inhibitor. The Company had a successful preNDA meeting with FDA in May 2019. After the Company has 12-month stability data on manufacturing batches, the Company will submit an NDA for TADFIN which is expected in Summer of 2020. BPH is an established multi-billion-dollar market.

"We are delivering on our strategy of providing multiple prostate cancer and prostate cancer supportive care medicines for the continuum of prostate cancer care," said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru. "We are pleased with the clinical progress we are making in advancing our product development program and in adding a high value, late stage drug candidate that complements our existing portfolio."

Highlights Third-Quarter Financial Results: Fiscal 2019 vs Fiscal 2018

Net revenues increased 77% to $9.7 million from $5.5 million;

Gross profit more than doubled to $6.6 million, or 68% of net revenues, from $3.1 million, or 56% of net revenues;

FC2 US prescription net revenues increased more than tenfold to $4.4 million from $0.4 million;

Operating loss significantly narrowed to $1.8 million from $5.0 million; and

Net loss was $2.8 million, or $0.04 per share, compared with $7.9 million, or $0.15 per share.

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

Net revenues rose 116% to $23.1 million from $10.7 million;

Gross profit climbed 183% to $15.8 million, or 69% of net revenues, from $5.6 million, or 52% of net revenues;

FC2 US prescription net revenues increased over tenfold to $9.4 million from $0.83 million;

FC2 public sector net revenues were $13.0 million, a 33% increase from $9.8 million;

Operating loss significantly narrowed to $5.0 million from $17.1 million (fiscal 2018 year to date included a $4.0 million loss for the settlement of Brazilian receivables); and

Net loss was $9.0 million, or $0.14 per share, compared with $16.0 million, or $0.30 per share.

"For the fiscal 2019 third quarter, we had impressive increases to net revenues and to gross profit which combined to substantially improve our bottom line," said Dr. Steiner. "Key contributors to the quarter’s performance included the continued significant ramp up of prescription sales of FC2 and the increased consumer demand for our PREBOOST/Roman Swipes. As our revenue base has grown to include increased FC2 prescription sales, our gross profit has risen substantially. The robust growth of the US FC2 prescription business remains noteworthy as it allows us to be less reliant on traditional intermittent ordering patterns typically seen in our FC2 public sector business. All of these factors combined to significantly narrow our operating loss for the quarter compared with the prior year period, which allows us to continue to invest in our multiple prostate cancer drug candidate clinical development efforts."

Financial Outlook

The Company reiterated its fiscal 2019 full year guidance of net revenues between $29 and 32 million, which represents a 95% increase over full year fiscal 2018, and gross margin of approximately 66%.

The Company does not expect to update the guidance for the full year fiscal 2019 provided above before the release announcing results for its fiscal 2019 year end. The Company notes that the statements of future performance made in this release, including the guidance for the full year fiscal 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 U.S. callers, or 412-317-0088 from outside the U.S., passcode 10133960. The replay will be available for one week, after which, the recording will be available via the Company’s website at View Source

Sutro Biopharma to Present at the 2019 Wedbush PacGrow Healthcare Conference

On August 8, 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 that its Chief Business Officer, Stephen Worsley, will present at the 2019 Wedbush PacGrow Healthcare Conference on Tuesday, Aug. 13 at 1:20 p.m. EDT in New York City (Press release, Sutro Biopharma, AUG 8, 2019, View Source [SID1234538383]).

A live webcast of the presentation will be accessible through the Events and Presentations page of the Investor Relations section on the company’s website at www.sutrobio.com. A replay of the webcast will be available following the event for approximately 30 days.