On August 12, 2021 Veru Inc. (NASDAQ: VERU), an oncology biopharmaceutical company with a focus on developing novel medicines for the management of prostate and breast cancer, reported that net revenues increased 71% and gross profit rose 113% for its fiscal 2021 third quarter ended June 30, 2021, setting new quarterly records for both net revenues and gross profit (Press release, Veru, AUG 12, 2021, View Source [SID1234586418]).

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Third Quarter Financial Highlights: Fiscal 2021 vs Fiscal 2020

Net revenues increased 71% to $17.7 million from $10.3 million
FC2 prescription net revenues climbed 150% to $13.5 million from $5.4 million
Gross profit rose 113% to $13.9 million from $6.5 million
Gross margin increased to 79% of net revenues from 63% of net revenues
Operating loss was $2.9 million versus $1.4 million
Net loss was $2.7 million, or $0.03 per share, compared with $3.0 million, or $0.05 per share.
Year-to-Date Financial Highlights: Fiscal 2021 vs Fiscal 2020

Net revenues increased 48% to $45.6 million from $30.8 million, a record high not only for the nine-month period ended June 30, 2021, but also a record high when compared to any prior full fiscal year
FC2 prescription net revenues climbed 79% to $32.9 million from $18.4 million
Gross profit rose 68% to $35.6 million from $21.2 million
Gross margin increased to 78% of net revenues from 69% of net revenues
Operating income was $14.8 million, which includes an $18.4 million gain on the December 2020 sale of the PREBOOST business. Adjusted operating loss, which excludes the gain on the sale of the PREBOOST business, was $3.6 million versus $3.5 million
Net income, which includes the gain on the sale of the PREBOOST business, was $11.7 million and diluted EPS was $0.14. Adjusted net loss, which excludes the gain on the sale of the PREBOOST business, was $6.7 million compared with $7.1 million and adjusted diluted loss per share was $0.09, compared with $0.11 per share
Balance Sheet Information

Cash and cash equivalents were $123.2 million as of June 30, 2021, versus $13.6 million as of September 30, 2020
Net accounts receivable were $8.3 million as of June 30, 2021, versus $5.2 million as of September 30, 2020
"We reported another record quarter based on all-time high quarterly and year to date FC2 net revenues from the U.S. business," said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru Inc. "We have enjoyed having this significant revenue stream to invest in our pharmaceutical programs. In fact, we have made great progress advancing our late-stage drug pipeline this past quarter, as we have initiated and are actively enrolling our: (i) Phase 3 VERACITY clinical trial of sabizabulin for metastatic castration and androgen receptor targeting agent resistant prostate cancer; (ii) Phase 2 clinical trial of VERU-100, a novel long-acting GnRH antagonist injection formulation for androgen deprivation therapy for advanced prostate cancer, and (iii) Phase 3 clinical trial of sabizabulin in hospitalized patients with COVID-19 at high risk for ARDS. Unfortunately, yet another COVID-19 viral infection wave has hit the United States and globally, making our COVID-19 drug development program highly relevant and timely as COVID-19 remains a severe threat with few effective therapies to complement the COVID-19 vaccination strategy."

Dr. Steiner further noted: "We are also making significant progress on our novel oral drug candidates for the treatment of advanced breast cancer. In the second half of the calendar year, we anticipate starting our: (i) Phase 3 ARTEST clinical trial of enobosarm monotherapy in a 3rd line metastatic setting in AR+ER+HER2- metastatic breast cancer; (ii) Phase 2b clinical trial of enobosarm in combination with abemaciclib, CDK 4/6 inhibitor, in a 2nd line metastatic setting in AR+ER+HER2- metastatic breast cancer; and (iii) Phase 2b clinical trial evaluating sabizabulin monotherapy and sabizabulin + Trodelvy (sacituzumab govitecan-hziy) combination therapy versus Trodelvy monotherapy in metastatic triple negative breast cancer. We have solidly transformed Veru into a premium oncology biopharmaceutical company seeking large market opportunities."

Pharmaceutical Pipeline Highlights:

Prostate Cancer Program

Sabizabulin, a Novel Oral Androgen Receptor Transport Disruptor, for the Treatment of Metastatic Castration and Androgen Receptor Targeting Agent Resistant Prostate Cancer – Phase 3 VERACITY Clinical Study – Enrolling.

Sabizabulin is a novel oral new chemical entity that targets microtubules in the cytoskeleton to disrupt androgen receptor transport. In June, the Company initiated the open label, randomized (2:1), multicenter Phase 3 VERACITY clinical trial evaluating sabizabulin 32mg versus an alternative androgen receptor targeting agent for the treatment of chemotherapy naïve men with metastatic castration resistant prostate cancer who have failed at least one androgen receptor targeting agent. The primary endpoint is median radiographic progression free survival. The Phase 3 VERACITY clinical trial is expected to enroll approximately 245 patients from 45 clinical centers.

VERU-100, a Novel Proprietary Long-Acting Gonadotropin-Releasing Hormone (GnRH) Antagonist Peptide 3-Month Subcutaneous Depot Formulation, for Androgen Deprivation Therapy of Advanced Prostate Cancer – Phase 2 Clinical Study – Enrolling.

In June, the Company initiated the Phase 2 clinical trial of VERU-100 androgen deprivation therapy for hormone sensitive advanced prostate cancer. The Phase 2 VERU-100 clinical trial is expected to enroll approximately 35 patients. VERU-100 formulation is designed to address the current limitations of commercially available androgen deprivation therapy. Androgen deprivation therapy is currently the mainstay of advanced prostate cancer treatment and is used as a foundation of treatment throughout the course of the disease even as other endocrine, chemotherapy, or radiation treatments are added or stopped. Specifically, VERU-100 is a chronic, long-acting GnRH antagonist peptide administered as a small volume, three-month depot subcutaneous injection without a loading dose. VERU-100 immediately suppresses testosterone with no testosterone surge upon initial or repeated administration, a problem that occurs with currently approved luteinizing hormone-releasing hormone agonists used for androgen deprivation therapy. There are no GnRH antagonist depot injectable formulations commercially approved beyond a one-month injection. A Phase 3 registration clinical trial has been agreed upon with FDA and will enroll approximately 100 men. The Phase 3 clinical study is anticipated to begin in Q4 calendar year 2021.

Breast Cancer Program

Enobosarm, a Novel Oral Selective Androgen Receptor Targeted Agonist, for the 3rd Line Treatment of Androgen Receptor Positive (AR+), Estrogen Receptor Positive (ER+) and Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Metastatic Breast Cancer – Phase 3 ARTEST Clinical Study.

Enobosarm is the first new class of targeted endocrine therapy in advanced breast cancer in decades. Enobosarm is an oral, new chemical entity, selective androgen receptor agonist that targets and activates the androgen receptor, a tumor suppressor, in AR+ER+HER2- metastatic breast cancer without the unwanted masculinizing side effects. Enobosarm has extensive nonclinical and clinical experience having been evaluated in 25 separate clinical studies in over 2,000 patients including three Phase 2 clinical studies in advanced breast cancer involving more than 250 patients. In the two Phase 2 clinical studies conducted in women with AR+ER+HER2- metastatic breast cancer, enobosarm demonstrated significant antitumor efficacy in heavily pretreated cohorts that failed estrogen receptor targeting agents, chemotherapy, and/or CDK 4/6 inhibitors and was well tolerated with a favorable safety profile. The Phase 3 multicenter, international, open label, and randomized (1:1) ARTEST registration clinical trial is designed to evaluate the efficacy and safety of enobosarm monotherapy versus physician’s choice of either exemestane everolimus or a SERM as an active comparator for the 3rd line treatment of metastatic AR+ER+HER2- breast cancer in approximately 210 patients who have failed a nonsteroidal aromatase inhibitor, fulvestrant and a CDK4/6 inhibitor. The primary endpoint is median radiographic progression-free survival. We expect to commence our pivotal enobosarm Phase 3 ARTEST clinical study in the second half of calendar year 2021.

Enobosarm in Combination with Abemaciclib, CDK 4/6 Inhibitor, for the 2nd Line Treatment of AR+ER+HER2- Metastatic Breast Cancer- Phase 2b Clinical Study.

CDK 4/6 inhibitor and estrogen blocking agent combination has become first line therapy for patients with ER+HER2- advanced breast cancer. Unfortunately, almost all patients will develop resistance to CDK 4/6 inhibitors, and will eventually, have breast cancer progression. Based on positive Phase 2 clinical data and the preclinical data supporting the use of enobosarm in combination with a CDK 4/6 inhibitor in patients that are CDK 4/6 inhibitor and estrogen blocking agent resistant, we plan to evaluate as 2nd line treatment in the metastatic setting the addition of enobosarm in combination with a CDK 4/6 inhibitor (abemaciclib) in a Phase 2b clinical study in subjects with AR+ER+HER2 metastatic breast cancer that have experienced disease progression on 1st line palbociclib + estrogen blocking agent in approximately 186 patients. The Phase 2b clinical study is expected to commence in calendar 2H 2021.

Sabizabulin, Novel Oral Cytoskeleton Disruptor Agent, Versus Trodelvy for the Treatment of Metastatic Triple Negative Breast Cancer- Phase 2b Clinical Study.

Sabizabulin is an oral, first-in-class, new chemical entity that targets and inhibits microtubules to disrupt the cytoskeleton. Sabizabulin is not a substrate for P-glycoprotein drug resistance protein. Over expression of P-glycoprotein is a common mechanism that results in taxane and chemotherapy resistance in metastatic triple negative breast cancer. Preclinical studies in human triple negative breast cancer grown in animal models demonstrate that sabizabulin significantly inhibits cancer proliferation, migration, metastases, and invasion of triple negative breast cancer tumors that have become resistant to paclitaxel (taxane). A three cohort Phase 2b clinical study is planned to start in calendar Q3 2021 to evaluate sabizabulin monotherapy and sabizabulin + Trodelvy combination therapy versus Trodelvy monotherapy in approximately 216 women with metastatic triple negative breast cancer that have become resistant to at least 2 systemic chemotherapies.

COVID-19 Program

Sabizabulin for the Treatment of Hospitalized COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome (ARDS) Phase 3 Clinical Study- Enrolling.

In May, we initiated our Phase 3 clinical trial of sabizabulin, which has both broad anti-viral and anti-inflammatory activities and which may serve a two-pronged approach to the treatment of COVID-19 virus infection and the subsequent debilitating inflammatory effects that lead to ARDS and death, in high risk hospitalized COVID-19 patients. The Phase 3 clinical trial is a double-blind, multicenter, multinational, randomized (2:1), placebo-controlled trial evaluating daily oral doses of 9mg sabizabulin for up to 21 days versus placebo in 300 hospitalized COVID-19 patients (200 subjects will be treated with sabizabulin and 100 subjects will receive placebo/standard of care) who are at high risk for ARDS. The primary efficacy endpoint will be proportion of patients that die on study up to Day 60. Secondary endpoints will include the proportion of patients without respiratory failure, days in ICU, WHO Ordinal Scale for Clinical Improvement change from baseline, days on mechanical ventilations, days in the hospital, and viral load. The study is being conducted in the United States, Brazil, Argentina, Mexico, and Colombia.

Benign Prostatic Hyperplasia Program

TADFIN (Tadalafil 5mg and Finasteride 5mg Combination Capsule) for the Treatment of Benign Prostatic Hyperplasia (BPH) – PDUFA Date December 2021.

TADFIN (tadalafil 5mg and finasteride 5mg combination capsule) was developed to treat urinary tract symptoms caused by BPH. Tadalafil (CIALIS) is currently approved for treatment of BPH and erectile dysfunction and finasteride is currently approved for treatment of BPH (finasteride 5mg PROSCAR) and male pattern hair loss (finasteride 1mg PROPECIA). The co-administration of tadalafil and finasteride has been shown to be more effective for the treatment of BPH than finasteride alone with the additional benefit of ameliorating erectile dysfunction. The PDUFA date is scheduled for December 2021. If approved, we expect to market and distribute TADFIN by telemedicine and telepharmacy sales channels.

Non-GAAP Financial Information
Certain financial results for fiscal years 2021 and 2020 are presented on both a reported and a non-GAAP, adjusted basis. Reported results were prepared in accordance with U.S. GAAP and include all revenue and expenses recognized during the period. The non-GAAP results are adjusted to exclude the one-time gain on sale of PREBOOST in the first quarter of fiscal year 2021. Management believes non-GAAP financial measures provide useful information to investors regarding the Company’s results of operations and assist management, analysts, and investors in evaluating the performance of the Company’s business. Non-GAAP financial measures should be considered in addition to, and not as a substitute for, measures of financial performance prepared in accordance with GAAP. The Company has reconciled these non-GAAP financial measures to the nearest reported GAAP measures in the reconciliation table below.

Event Details
Interested parties 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. The call will also be available through a live, listen-only audio broadcast via the Internet at www.verupharma.com. Listeners are encouraged to visit the website at least 10 minutes prior to the start of the scheduled presentation to register, download and install any necessary software. A playback of the call will be archived and accessible on the same website for at least three months. A telephonic replay of the conference call will be available, beginning the same day at approximately 12 p.m. (noon) ET by dialing 877-344-7529 for U.S. callers, or 412-317-0088 from outside the U.S., passcode 10157539, for one week.