Veru Announces the Presentation of a Phase 1b/2 Clinical Study Update for Sabizabulin 

Veru Inc. recently announced updated clinical results from the ongoing Phase 1b/2 clinical study of sabizabulin (VERU-111), an oral cytoskeleton disruptor being evaluated for the treatment of metastatic castration-resistant prostate cancer in men who progressed on an androgen receptor targeting agent, were accepted for presentation at the European Association of Urology 36^th Annual Congress. The Congress was held virtually from July 8-12, 2021.

Poster Discussion Session
Abstract # P0859: Sabizabulin (VERU-111), an oral cytoskeleton disruptor, to treat men with metastatic castration resistant prostate cancer who progressed on an androgen receptor targeting agent.
Presenter: Dr. Robert H. Getzenberg, Veru – Executive Vice President for Medical Affairs
Poster Discussion Session: #29 – Metastatic Prostate Cancer

Additional information on the meeting can be found on the EAU website https://eaucongress.uroweb.org/

“The data from our Phase 1b/2 trial show that oral, daily sabizabulin is well tolerated and based upon its efficacy has the potential to fill the largest and growing unmet clinical need in men who have metastatic castration resistant prostate cancer and who have developed progression of prostate cancer while being treated with an androgen receptor targeting agent, but prior to using IV chemotherapy,” said Dr. Mitchell S. Steiner, Chairman, President and CEO of Veru Inc. “We are excited to be initiating the Phase 3 VERACITY trial in this patient population.”

Veru Inc. is an oncology biopharmaceutical company with a focus on developing novel medicines for the management of prostate cancer and breast cancer. Veru’s prostate cancer pipeline includes: sabizabulin, an oral, first-in-class, new chemical entity that targets the cytoskeleton disruptor which in prostate cancer also disrupts the transport of the androgen receptor. A Phase 3 VERACITY clinical trial evaluating the efficacy and safety of sabizabulin in approximately 245 men for the treatment of metastatic castration and androgen receptor targeting agent resistant prostate cancer is enrolling. VERU-100, a novel, proprietary gonadotropin releasing hormone antagonist peptide long acting 3-month subcutaneous injection formulation for androgen deprivation therapy to treat hormone sensitive advanced prostate cancer, is currently enrolling in a Phase 2 trial, and the Phase 3 clinical trial is planned to initiate in calendar Q4 2021. Veru’s breast cancer pipeline includes: enobosarm, an oral, first-in-class, new chemical entity, selective androgen receptor agonist that targets the androgen receptor, a tumor suppressor, to treat AR+ER+HER2- metastatic breast cancer without unwanted masculinizing side effects. The enobosarm clinical program is initially focusing on 2 indications: 1) Phase 3 ARTEST clinical trial to evaluate enobosarm monotherapy in a 3rd line metastatic setting in approximately 210 subjects with AR+ER+HER2- metastatic breast cancer (≥ 40% AR positivity) who have failed nonsteroidal aromatase inhibitor, fulvestrant, and a CDK 4/6 inhibitor which is anticipated to commence calendar Q3 2021; 2) Phase 2 study to evaluate the efficacy and safety of enobosarm and CDK 4/6 inhibitor, abemaciclib, combination compared to estrogen blocking agent (Active Control) for the treatment of AR+ER+HER2- metastatic breast cancer (≥ 40% AR positivity) in a 2nd line metastatic setting in approximately 106 patients who have failed 1^st line treatment in a metastatic setting with CDK 4/6 inhibitor, palbociclib, in combination with either an aromatase inhibitor or fulvestrant which is expected to commence in calendar Q3 2021. Sabizabulin will also be evaluated in a three arm Phase 2b clinical study planned to initiate in calendar Q3 2021 to evaluate oral daily dosing of sabizabulin monotherapy, TRODELVY monotherapy, and sabizabulin + TRODELVY combination therapy in approximately 156 women with metastatic triple negative breast cancer that have become resistant to at least two systemic chemotherapies including a taxane. Based on positive Phase 2 results on the reduction of mortality, sabizabulin is also being evaluated in a Phase 3 clinical trial for the treatment of hospitalized patients with moderate to severe COVID-19 who are at high risk for acute respiratory distress syndrome in approximately 300 subjects and is currently enrolling.

The company’s Sexual Health Business commercial product is the FC2 Female Condom (internal condom) (FC2), an FDA-approved product for dual protection against unintended pregnancy and the transmission of sexually transmitted infections. The company’s Female Health Company Division markets and sells FC2 commercially and in the public health sector both in the US and globally. In the US, FC2 is available by prescription through multiple third-party telemedicine and internet pharmacy providers and retail pharmacies. In the global public health sector, the Company markets FC2 to entities, including ministries of health, government health agencies, UN agencies, nonprofit organizations and commercial partners, that work to support and improve the lives, health and well-being of women around the world. The second potential commercial product, if approved, expected for the Sexual Health Business is TADFIN (tadalafil 5 mg and finasteride 5 mg) capsule dosed daily for benign prostatic hyperplasia (BPH). An NDA was filed by FDA in April 2021 with a PDUFA date in December 2021. The company plans to initially launch through telemedicine and telepharmacy sales channels. For more information, visit www.verupharma.com.