Veru : Corporate Presentation, November 2023

Veru Inc.

Nasdaq:VERU

Focused on metabolic diseases and oncology

Veru Corporate Presentation

November 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 Phase 2b study of enobosarm in combination with a GLP-1 agonist for the treatment of obesity and related muscle wasting, the confirmatory Phase 3 study of sabizabulin for certain COVID-19 patients (if undertaken), the Phase 3 study of sabizabulin in adult hospitalized patients with ARDS (if undertaken), the Phase 2b/3 study of enobosarm in combination with abemaciclib for the 2nd line treatment of AR+ ER+ HER2 metastatic breast cancer, and whether any of such studies will meet any of its primary or secondary endpoints; whether and when the IND for the enobosarm/GLP-1 combination study will be filed with the U.S. FDA, whether the FDA will require any additional studies or any preclinical studies, whether the study, if started, will have the same target patient populations as described in this presentation, and whether and when the planned study will commence enrollment and read out data; whether the historical clinical results showing enobosarm's effect on preventing muscle wasting, increasing or maintaining muscle mass and bone density or assisting with preferential fat loss will be replicated to any significant degree or at all in the planned Phase 2b study or in any future study and whether, if approved, any such results would be seen in commercial clinical use; whether and when any of the planned interim analyses in the planned Phase 3 confirmatory study of sabizabulin for certain COVID patients or in ARDS patients or in 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 COVID-19 and ARDS or any other indication; whether the current and future clinical development efforts of the Company, including all studies of sabizabulin in COVID-19, ARDS, or any other infectious disease indications or enobosarm in obesity or 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 government and private payors will provide sufficient coverage for enobosarm for obesity or any of the Company's other drugs, if approved in each case; whether the companies that develop and commercialize GLP-1 drugs for obesity will accept the use of enobosarm in combination with their respective products; whether the intellectual property portfolio for enobosarm is sufficient to protect the Company's interest in enobosarm in obesity, breast cancer or any other indication and whether it will prevent competitors from developing SARMs for the same indication or whether the Company will have the resources or be successful in enforcing its intellectual property rights; whether and how long the relative lack of competition in the obesity market for drugs and drug candidates that might help mitigate muscle wasting will continue and what the effects of any such competition might be on the Company's prospects in the sector; whether enobosarm will become a treatment, in combination or alone, for obesity or breast cancer, and whether sabizabulin will become a treatment for broad ARDS or COVID-19; 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 and whether the Company will ever be able to liquidate the preferred stock that it owns in Blue Water; whether, when and how many shares may be sold under the Lincoln Park Capital Fund equity line; whether the cash raised by any future equity offering will be sufficient for the Company's planned or expected operations; 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 Company's existing product, FC2 and and any future products, if approved, possibly not being commercially successful; 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, 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

Program

Mechanism

Indication

2023

2024

2025

2026

Metabolic

Enobosarm and GLP-1

receptor agonist combination

Selective androgen receptor modulator (SARM)

+

GLP-1 Receptor agonist

Obese or overweight elderly patients receiving a GLP-1 RA

		Phase 2b
	Phase 2b	Protect	Phase 2b	Planned
IND	muscle loss
FPI -75	Rescue
		from GLP-1	Open-label 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) study -		Phase 3		Phase 3
	FPI -408		data
Hospitalized patients with			Planned
viral ARDS**

*Subject to availability of funds ** Subject to receiving HHD or DoD funding

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Currently approved GLP-1 receptor agonist drugs for the treatment of obesity have demonstrated significant loss of both fat and muscle in obese patients

• Weight loss drugs GLP-1 receptor agonists demonstrated a 6.2-12.4% average total weight loss in third-party clinical trials1,2
• 20-50%of the total weight loss reported by patients in those third- party clinical trials was attributed to muscle loss1,3,4,5

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 |

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Currently approved GLP-1 RA drugs for the treatment of obesity have

demonstrated significant loss of both fat and muscle in clinical trials

The target population is the at risk obese or overweight patients with low muscle reserves

• Approximately 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
• • 30% of people over 60 years old and more than 50% of those over 80 years old have sarcopenia
  • Patients with sarcopenic obesity, high fat mass with very low muscle mass, have the greatest risk to develop muscle weakness because of critically low muscle mass with weight-loss drug treatment2-4
  • Elderly patients with sarcopenia obesity have a higher risk of frailty/muscle weakness, which can lead to poor balance, decrease in gait, loss of muscle strength, functional limitations, mobility disability, falls and fractures, higher hospitalization rate, and increased mortality 2-4

Normal5

Sarcopenic obesity5

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	5

Enobosarm is a novel oral selective androgen receptor modulator (SARM) designed to reduce fat mass and increase lean mass (muscle and bone)

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

Data from clinical trials and preclinical studies support enobosarm's potential:

• Once-a-day oral dosing

• Activates the androgen receptor, a well-established mechanism

• Tissue selective

• Improves muscle mass and physical function2,6

• Stimulates lipolysis, inhibits lipogenesis, and decreases fat mass7,8

Chemical structure of enobosarm

• Builds and heals bone-potential to treat bone loss/osteoporosis3-5
• Lack of Masculinizing effects
• No liver toxicity

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 Leciejewska N et al. J Phys and Pharma 70:525-533, 2019

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Enobosarm clinical data from 5 clinical trials conducted by GTx or Merck in 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

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Healthy elderly men (60 yo) and postmenopausal women receiving enobosarm in GTx conducted Phase 2 double-blind placebo controlled clinical trial (G200501) demonstrated improved lean body mass and physical function

•	120 subjects enrolled
•	12 weeks of treatment	% Change in stair climb power
% Change in lean mass

			N=24 for each group			N=24 for each group
0	0.1 0.3	1	3	0.1 0.3	1	3
	Milligrams	0
		Milligrams

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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Reported effects of enobosarm on muscle and physical function in patients with cancer: a double-blind, randomized controlled Phase 2b (G200502) clinical trial conducted by GTx1

Change in total lean mass at Day 113/EOS compared to baseline

Change in body weight at Day 113/EOS compared to baseline

P< 0.041 enobosarm 3mg vs placebo

Change in stair climb time and power at Day 113/EOS compared to baseline

• Mean age >60 yo

• 159 subjects enrolled

• 16 weeks of treatment

1 Dobs AS et al. Lancet Oncol 14:335-345, 2013

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Phase 3 randomized, double-blind,placebo-controlled 504 clinical trial of evaluating the effects of enobosarm on muscle wasting in patients with non-small cell lung cancer on first line platinum plus a taxane chemotherapy conducted by GTx1

Lean body mass (muscle)	3mg enobosarm treatment in 321 subjects enrolled for 21 weeks
Body weight	Stair climb power
Up to Day 84 visit	Up to Day 84 visit	Up to Day 84 visit

Up to Day 147 visit

Up to Day 147 visit

Up to Day 147 visit

1 CSR data on file Veru

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