Veru Inc.

Nasdaq:VERU

Late clinical stage biopharmaceutical company

Focused on metabolic diseases and oncology

Veru Corporate Presentation

October 2023

Forward looking statements and safe harbor

The statements in this release that are not historical facts are "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this release include statements regarding: the planned design, enrollment, timing, commencement, interim and full data readout timing, scope, regulatory pathways, and results of the Company's current and planned clinical trials, including the confirmatory Phase 3 study of sabizabulin for certain COVID-19 patients, the Phase 3 study of sabizabulin in adult hospitalized patients with ARDS, the Phase 2b/3 study of enobosarm in combination with abemaciclib for the 2nd line treatment of AR+ ER+ HER2 metastatic breast cancer, the Phase 2b/3 study of enobosarm in bone-onlynon-measurable hormone receptor and HER2- metastatic breast cancer, the Phase 3 study of sabizabulin in hospitalized influenza patients at high risk of ARDS, and studies of sabizabulin in smallpox virus and Ebola virus, and whether any of such studies will meet any of its primary or secondary endpoint; whether and when any of the planned interim analyses in the planned Phase 3 confirmatory study of sabizabulin for certain COVID patients or any other trial will occur and what the results of any such interim analyses will be; whether the results of any such interim analyses or any completed Phase 3 study or any other interim data will be sufficient to support a new EUA application or an NDA for sabizabulin for any indication; whether and when any potential EUA or NDA would be grated; whether and when the Company will meet with BARDA regarding any potential partnering opportunities and whether those efforts will be successful, and when the Company might learn the results of any potential partnering efforts with BARDA; whether and how the Company will fund the planned Phase 3 studies of sabizabulin in influenza, pox virus, COVID-19 and ARDS; whether the current and future clinical development efforts of the Company, including all studies of sabizabulin in COVID-19, ARDS, smallpox or any other infectious disease indications or enobosarm in oncology indications, and any of their results will demonstrate sufficient efficacy and safety and potential benefits to secure FDA approval of any of the Company's drug candidates; whether the drug candidates will be approved for the targeted line of therapy; whether sabizabulin will become a treatment for broad ARDS; whether the Company's FC2 telemedicine portal sales will grow or replace prior revenue from the U.S. prescription sales of FC2; whether the Company will recover any of the monies owed it by The Pill Club; whether and when the Company will receive the remaining installments from Blue Water in connection with the sale of ENTADFI or will receive any of the potential sales milestones related thereto; whether, when and how many shares may be sold under the Lincoln Park Capital Fund equity line; and whether the Company's current cash will be sufficient to fund its planned or expected operations. These forward-looking statements are based on the Company's current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: the development of the Company's product portfolio and the results of clinical studies possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical studies and the ability to enroll subjects in accordance with planned schedules; the ability to fund planned clinical development as well as other operations of the Company; the timing of any submission to the FDA or any other regulatory authority and any determinations made by the FDA or any other regulatory authority; the possibility that as vaccines, anti-virals and other treatments become widely distributed the need for new COVID-19 treatment candidates may be reduced or eliminated; government entities possibly taking actions that directly or indirectly have the effect of limiting opportunities for sabizabulin as a COVID-19 treatment, including favoring other treatment alternatives or imposing price controls on COVID-19 treatments; the Company's existing products, including FC2 and ENTADFI and, if authorized, sabizabulin, and any future products, if approved, possibly not being commercially successful; the effects of the COVID-19 pandemic and measures to address the pandemic on the Company's clinical studies, supply chain and other third-party providers, commercial efforts, and business development operations; the ability of the Company to obtain sufficient financing on acceptable terms when needed to fund development and operations; demand for, market acceptance of, and competition against any of the Company's products or product candidates; new or existing competitors with greater resources and capabilities and new competitive product approvals and/or introductions; changes in regulatory practices or policies or government-driven healthcare reform efforts, including pricing pressures and insurance coverage and reimbursement changes; risks relating to the Company's development of its own dedicated direct to patient telemedicine and telepharmacy services platform, including the Company's lack of experience in developing such a platform, potential regulatory complexity, and development costs; the Company's ability to protect and enforce its intellectual property; the potential that delays in orders or shipments under government tenders or the Company's U.S. prescription business could cause significant quarter-to-quarter variations in the Company's operating results and adversely affect its net revenues and gross profit; the Company's reliance on its international partners and on the level of spending by country governments, global donors and other public health organizations in the global public sector; the concentration of accounts receivable with our largest customers and the collection of those receivables; the Company's production capacity, efficiency and supply constraints and interruptions, including potential disruption of production at the Company's and third party manufacturing facilities and/or of the Company's ability to timely supply product due to labor unrest or strikes, labor shortages, raw material shortages, physical damage to the Company's and third party facilities, COVID-19 (including the impact of COVID-19 on suppliers of key raw materials), product testing, transportation delays or regulatory actions; costs and other effects of litigation, including product liability claims and securities litigation; the Company's ability to identify, successfully negotiate and complete suitable acquisitions or other strategic initiatives; the Company's ability to successfully integrate acquired businesses, technologies or products; and other risks detailed from time to time in the Company's press releases, shareholder communications and Securities and Exchange Commission filings, including the Company's Form 10-K for the fiscal year ended September 30, 2022 and subsequent quarterly reports on Form 10-Q. These documents are available on the "SEC Filings" section of our website at www.verupharma.com/investors. The Company disclaims any intent or obligation to update these forward-looking statements.

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Drug candidate pipeline

Biopharmaceutical company focused on metabolic diseases and cancer

Program

Mechanism

Indication

2023

2024

2025

2026

Metabolic

GLP-1 +/-

enobosarm

Selective androgen receptor modulator (SARM)

Obesity

Weight loss; preferential fat

loss without muscle loss

Phase 2b

Phase 2b

Protect

Phase 2b

Planned

muscle loss

FPI -75

Rescue

from GLP-1

Roll-over data

data

Breast Cancer

Enobosarm

+/-

abemaciclib combination

Selective androgen receptor modulator (SARM)

+

CDK 4/6 inhibitor

Phase 3 ENABLAR-2

AR+ ER+HER2- metastatic

breast cancer

(2nd line metastatic setting)

Lilly

clinical collaboration and supply agreement

Phase 3 FPI

Phase 3 data-

Stage 1- 160

stage 1

Open and active

Infectious Disease- Acute Respiratory Distress Syndrome

Sabizabulin

Oral microtubule

Disruptor

Broad host targeted

antiviral and anti-

inflammatory agent

Phase 3 (902) study-

Hospitalized COVID-19

Positive Phase 3 study

Completed

patients at high risk for

Fast Track Designation

ARDS

Phase 3 (904) confirmatory

Phase 3

Phase 3

Planned

FPI -408

data

study - Hospitalized

Will seek HHS or

patients with viral ARDS

DOD funding

3

Muscle loss significant side effect of weight-lossGLP-1 receptor agonists

4

Weight-loss drugs like Ozempic, Wegovy, Mounjaro and other GLP-1 drugs cause significant loss of both fat and muscle

  • Weight loss drugs GLP-1 receptor agonists cause in a 6.2-12.4% average total weight loss1,2
  • Muscle loss makes up 20-50% of the total weight lost1,3,4,5

1 Wilding JPH et al. NEJM 384:989-1002, 2021|2 Wegovy FDA PI | 3 Sargeant JA et al. Endocrinol Metab 34:247-262, 2019| Ida S et al. Current Diabetes Rev 17:293-303, 2021|5 McGrimmon RJ et al. Diabetologia 63:473-485, 2020 |

5

Weight-loss drugs cause significant loss of both fat and muscle

Target at risk obese or overweight patients with low muscle reserves

Normal body composition5

42% of older adults (>60 yo) have obesity or overweight and could benefit from weight-loss drugs1

Older obese or overweight patients with low muscle mass/ functional limitations

Up to 30-50% of older obese patients have sarcopenic obesity,

high fat mass with very low muscle mass, and have the greatest

risk to develop muscle weakness because of critically low muscle

Sarcopenic obesity5

mass with weight-loss drug treatment2-4

  • Frailty/muscle weakness leads to poor balance, decrease in gait, loss of muscle strength, functional limitations, mobility disability, falls and fractures, loss of independence, higher hospitalization rate, and increased mortality 2-4

CT scans

1 CDC |2 Wennamethee SG et al. Current Diabetes Reports 2023|3 Spanoudaki M et al. Life 13:1242, 2023|4 Roh E et al. Front Endocrinol 11: 2020|5 Batsis J et al. Nature Reviews Endocrinology 14:513-537, 2018

6

Preventing muscle loss with weight-loss drugs

Competition

  • The competitive landscape for weight-loss drugs using incretins
    • Rapidly enlarging global market with many new companies developing incretins
    • Incretins cause weight loss by significant loss of both fat and muscle
  • Current muscle loss competition in the clinics
    • In July 2023, Lilly bought Versanis Bio for $2 billion dollars to combine bimagrumab (activin receptor type 2B antagonist) with Mounjaro(tirzepatide), a GLP agent, to prevent muscle loss.
      • Completed Phase 2 (NCT03005288) evaluating Bimagrumab vs placebo in 78 overweight or obese diabetic patients at 48 weeks
        • Increased muscle by 1.7kg at 48 weeks
      • Phase 2 clinical study (NCT05616013) Safety and Efficacy of Bimagrumab and Semaglutide in Adults who are Overweight or Obese
        • IV Bimagrumab versus IV Bimagrumab + semaglutide
        • Primary endpoint is change in total body weight from baseline at 48 weeks
        • Enrollment- 495
        • Start- 11/2022 and End- 9/2025

7

Enobosarm is a novel oral selective androgen receptor modulator (SARM)

Reduces fat mass and increases lean mass (muscle and bone)

Enobosarm is a non-steroidal, selective androgen receptor agonist1, 2

  • Once-a-dayoral daily dosing
  • Activate the androgen receptor, a well-established mechanism
  • Tissue selective
    • Anabolic on muscle to improve muscle mass and physical function2,6
    • Decreases fat mass7
    • Builds and heals bone-potential to treat bone loss/osteoporosis3-5

Chemical structure of enobosarm

  • Selective tissue activities translate to a favorable side-effect profile7
    • Non-masculinizing(no unwanted hair growth or acne)
    • No liver toxicity
    • No increases in hematocrit
    • Neutral on prostate

1 Narayanan R et al. Mol Cell Endocrinol 2017|2 Dalton JT et al. Curr Opin Support Palliat Care 7:345-351, 2013|3Kamrakova M et al Calcif Tissue Int 106:147-157,2020|4 Hoffman DB et al. J Bone Metab 37:243-255, 2019|5 Kearbey JD et al Pharm Res 26:2471-2477, 2009| 6Dobs AS et al. Lancet Oncol 14:335-45, 2013|7Dalton JT et al. J Cachexia Sarcopenia Muscle 2:153-161, 2011

8

Veru has clinical data from 5 clinical studies in older subjects with and without muscle wasting

Sarcopenic= presence of low muscle mass; LBM= lean body mass; SCP= stair climb power (Watts), power exerted in a 12-step stair climb; CSR=clinical study report ; N.S.=not significant

9

Enobosarm improved lean body mass and physical function in healthy elderly men (>60 yo) and postmenopausal women: Phase 2 double-blindplacebo-controlled 501 study1

120 subjects enrolled

12 weeks of treatment

% Change in stair climb power

% Change in lean mass

Metabolic changes

Blood glucose was significantly decreased by an average of 6.9 ± 2.5 mg/dL in the enobosarm 3mg versus placebo (n=24; P = 0.006)

Blood insulin was reduced by 2.2 ± 1.1 µIU/mL in the enobosarm 3mg versus placebo (n=24;

P = 0.052)

Insulin resistance (HOMA-IR) was reduced in the enobosarm 1-mg and 3-mg treatment groups (placebo = 2.6% ± 8.6, 1 mg = −9.3% ± 5.5, 3 mg = −27.5% ± 7.6 )( P = 0.013 3 mg vs. placebo)

1 Dalton JT et al. J Cachexia Sarcopenia Muscle 2:153-161, 2011

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Veru Inc. published this content on 31 October 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 31 October 2023 13:18:08 UTC.