VERU : Management’s Discussion and Analysis of Financial Condition and Results of

Overview

Veru Inc. is an oncology biopharmaceutical company with a focus on developing
novel medicines for the management of prostate and breast cancers. Revenues
generated by our growing sexual health division are used to invest and partly
fund the clinical development of our cancer drug pipeline.

The Company’s prostate cancer drug pipeline includes VERU-111, VERU-100 and
Zuclomiphene citrate.

VERU-111 for the treatment of men with metastatic castration resistant prostate
cancer who have also become resistant to one androgen receptor targeting agent

VERU­111 is an oral, first-in-class, new chemical entity that targets,
crosslinks, and disrupts alpha and beta tubulin subunits of microtubules to
disrupt the cytoskeleton. VERU­111 is being evaluated in open label Phase 1b and
Phase 2 clinical studies in men with metastatic castration and androgen receptor
targeting agent resistant prostate cancer in approximately 80 men. In July 2020,
the Company had an FDA meeting and received positive input from FDA on the
pivotal Phase 3 trial design for VERU-111. The Company anticipates starting the
Phase 3 pivotal study evaluating VERU­111 for men with metastatic castration
resistant prostate cancer who have also become resistant to one androgen
receptor targeting agent (VERACITY study) in the first quarter of calendar year
2021.

VERU-100 for the palliative treatment of advanced prostate cancer

VERU­100 is a novel, proprietary long-acting gonadotropin-releasing hormone
(GnRH) antagonist peptide 3 month subcutaneous depot formulation designed to
address the current limitations of commercially available androgen deprivation
therapies (ADT). There are no GnRH antagonist depot injectable formulations
commercially approved beyond a one-month duration. A Phase 2 study to evaluate
VERU­100 dosing is anticipated to begin early in the first quarter of calendar
year 2021 and Phase 3 registration study in 100 men will commence in the second
half of calendar year 2021.

Zuclomiphene citrate for the treatment of men who have hot flashes caused by
androgen deprivation therapy for advanced prostate cancer

Zuclomiphene citrate is an oral nonsteroidal estrogen receptor agonist being
developed to treat hot flashes, a common side effect caused by ADT in men with
advanced prostate cancer. The Company is planning an End of Phase 2 meeting with
the FDA in the last quarter of calendar year 2021.

The Company’s breast cancer drug pipeline includes Enobosarm and VERU-111.

Enobosarm, selective androgen receptor targeting agonist, for the treatment of
androgen receptor positive (AR+), estrogen receptor positive (ER+) and human
epidermal growth factor receptor 2 (HER2-) metastatic breast cancer

Enobosarm is an oral, first-in-class, new chemical entity, selective androgen
receptor agonist that targets the androgen receptor (AR) in AR+/ER+/HER2-
metastatic breast cancer without unwanted virilizing side effects. Enobosarm is
the first new class of targeting endocrine therapy in advanced breast cancer in
decades. Enobosarm has extensive nonclinical and clinical experience having been
evaluated in 25 separate clinical studies in over 2,100 subjects, including five
prior 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- breast cancer, enobosarm demonstrated significant antitumor
efficacy in heavily pretreated cohorts and was well tolerated with a favorable
safety profile. In October 2020, the FDA agreed to the Phase 3 registration
clinical trial design to evaluate the efficacy and safety of enobosarm,
selective androgen receptor targeting agonist, versus active control, either
exemestane or tamoxifen (physician’s choice), for the treatment of ER+/HER2-
metastatic breast cancer in approximately 240 patients who have failed a
nonsteroidal aromatase inhibitor (anastrozole or letrozole), fulvestrant, and a
CDK 4/6 inhibitor, but prior to IV…