Veru, Inc.

Agreement reached with FDA on confirmatory Phase 3 clinical trial design for sabizabulin treatment of hospitalized COVID-19 adult patients at high risk for acute respiratory distress syndrome (ARDS), including two planned interim efficacy analyses ENTADFI®product sold for $20 million, plus up to an additional potential $80 million from sales milestones Common stock purchase agreement with Lincoln Park Capital for up to $100 million provides financial flexibility Company reported positive preclinical data for sabizabulin for influenza induced ARDS and for poxvirus Company to host conference call and webcast today at 8:00 a.m. ET MIAMI, FL, May 11, 2023 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of breast cancer and for SARS-CoV-2 and other viral ARDS-related diseases, today announced financial results for its fiscal 2023 second quarter and provided a business update. “This past quarter, we prioritized our clinical development program to focus on those indications with the largest market opportunities and with the potential for meaningful Phase 3 clinical data results in 2024 for both enobosarm for 2nd line AR+ ER+ HER2- metastatic breast cancer and sabizabulin for SARS-CoV-2 viral ARDS,” said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru. “As part of this prioritization, we are planning to also expand enobosarm into bone-only, metastatic breast cancer and sabizabulin into influenza-induced ARDS.” Dr. Steiner added, “On the regulatory front, we received FDA clarity to continue advancing our ENABLAR-2 Phase 2b/3 clinical trial for metastatic breast cancer and agreement to pursue our confirmatory Phase 3 clinical trial for hospitalized COVID-19 adult patients at high risk for ARDS. We also reduced our cash burn rate, and in parallel, we increased available capital through the completed ENTADFI sale and the Lincoln Park Capital transaction. We are also seeking partnerships for both our clinical drug candidates. In addition, we continue to invest in Veru’s FC2 Female Condom® telemedicine portal and establish partnerships to grow our FC2 prescription business in the U.S.” Breast Cancer Program Updates Enobosarm, a Novel Oral Selective Androgen Receptor Agonist, and Abemaciclib, a CDK 4/6 Inhibitor, Combination Therapy for the 2nd Line Treatment of AR+ ER+ HER2- Metastatic Breast Cancer In March 2023, the Company made the strategic decision to focus on the ENABLAR-2 Phase 2b/3 trial (combination of enobosarm + abemaciclib). The decision to focus on an earlier line of treatment is supported by the larger target patient population in a second line metastatic setting for AR+ ER+ HER2- breast cancer patients. On March 30, 2023, the Company met with the FDA to gain further regulatory clarity for the ongoing Phase 2b/3 clinical trial design and program. The Phase 2b/3 study has been amended to accommodate the FDA’s latest recommendations to support a potential registration. In the first stage of the trial, the dose of enobosarm in the abemaciclib combination is being optimized and the efficacy and safety of the combination therapy is being assessed compared to an estrogen blocking agent. The primary endpoint for stage 1 of the study is objective response rate (ORR), an endpoint that the FDA recognizes as an appropriate surrogate endpoint for clinical benefit for a possible accelerated approval. In Stage 2 of the Phase 2b/3 study, we plan to enroll approximately 210 subjects in a multicenter, open label, randomized (1:1), active control clinical study, to evaluate the efficacy and safety of enobosarm plus abemaciclib combination therapy versus an alternative estrogen blocking agent (SERD or an aromatase inhibitor) in subjects with AR+ ER+ HER2- metastatic breast cancer who have failed a CDK4/6 inhibitor plus an estrogen blocking agent (non-steroidal aromatase inhibitor or SERD). The primary endpoint is progression free survival. The regulatory strategy and clinical design for the Phase 2b/3 ENABLAR-2 clinical study could yield an accelerated approval from stage 1 and full approval from stage 2 for the 2nd line abemaciclib and enobosarm combination treatment of AR+ ER+ HER2- metastatic breast cancer. We anticipate having clinical data for the Phase 2b/3 ENABLAR-2 study in 2024. We have a collaboration and supply agreement with Eli Lilly and Company. Enobosarm, a Novel Oral Selective Androgen Receptor Agonist, for the Treatment of Bone-only Nonmeasurable ER+ HER2- Metastatic Breast Cancer The Company is planning a Phase 2b/3 study in bone-only nonmeasurable hormone receptor and HER2- metastatic breast cancer with enobosarm. Enobosarm has the ability to build both cortical and trabecular bone and muscle in clinical and/or nonclinical models, which may reduce the incidence of skeletal related events caused by bone metastases and positively impact quality of life for patients. Infectious Disease: Viral Induced Acute Respiratory Distress Syndrome (ARDS) Program Updates Sabizabulin, a Novel OralMicrotubule Disruptor, for the Treatment of Hospitalized Moderate to Severe COVID-19 Patients at High Risk for ARDS In February 2023, the FDA declined to grant at this time an Emergency Use Authorization (EUA) for sabizabulin for hospitalized COVID-19 patients at high risk for ARDS because of the possibility of unknown influences or uncertainties in the study. Nonetheless, in communicating its decision, the FDA remains committed to working with the Company for the future development of sabizabulin. In April 2023, the Company met with the FDA and reached an agreement on the trial design and path forward for a confirmatory Phase 3 study, which will include 408 subjects with a primary endpoint of all-cause mortality at Day 60. In addition, the study’s treatment population is expanded to include all hospitalized patients that require oxygen (WHO-4, WHO-5 and WHO-6) with no requirement to have a comorbidity. In order to get a potentially efficacious drug to patients in an efficient time frame, two planned interim efficacy analyses will be conducted: As requested by FDA, the first planned interim analysis will occur when 204 patients (50%) have completed the Day 60 primary efficacy endpoint, and the second planned interim analysis is expected to occur when 290 patients (71%) have completed the Day 60 primary efficacy endpoint. If either of the interim efficacy analyses meets the statistical significance criteria, the trial could be stopped for efficacy. Should the pre-specified primary efficacy endpoint analysis demonstrate a statistically significant effect on all-cause mortality favoring sabizabulin, the Company may consider a new request for an EUA and/or a submission of an NDA, “as the Company would potentially have two adequate and well controlled trials for review.” The confirmatory Phase 3 clinical trial is expected to enroll in the second half of 2023, and the first planned interim analysis is expected to be conducted in 2024. Sabizabulin, a Novel OralMicrotubule Disruptor, for the Treatment of Hospitalized Moderate to Severe Influenza Patients at High Risk for ARDS In April 2023, the Company announced preclinical results of sabizabulin demonstrating robust anti-inflammatory activity with improved outcomes in an Influenza-Induced Pulmonary Inflammation Mouse ARDS model. As a result, Veru is planning a Phase 3 study of sabizabulin in hospitalized influenza patients at high risk for ARDS. Sabizabulin, a Novel OralMicrotubule Disruptor, for the Treatment of Viruses that Pose Serious Worldwide Global Threats In April 2023, the Company announced preclinical in vitro study results that demonstrate sabizabulin prevented both the release of Vaccinia poxvirus from infected cells and the spread of Vaccinia poxvirus to healthy cells. As a result, Veru is planning a pre-Investigational New Drug (IND) meeting with the FDA to discuss the development of sabizabulin for smallpox virus and Ebola virus under the Animal Rules FDA regulatory approval pathway. Urev - Sexual Health Program Updates FC2 Female Condom® (internal condom) In April 2023, the Company entered into a supply agreement with Afaxys Group Services, LLC (AGS), a healthcare company, to offer FC2 Female Condom® through the AGS Group Purchasing Organization (GPO) for up to 31 million individuals that depend on public health centers for essential healthcare. The Company continues to invest in and grow its direct to patient telemedicine portal and is focused on executing new contracts with additional telemedicine and internet fulfillment pharmacy partners to provide coverage in all 50 states in the U.S. ENTADFI® (finasteride and tadalafil) capsules for oral use, a New Treatment for Benign Prostatic Hyperplasia (BPH) In April 2023, the Company sold ENTADFI®, an FDA-approved oral, once daily product for BPH for men with an enlarged prostate experiencing the signs and symptoms of BPH for up to 26 weeks, to Blue Water Biotech for $20 million ($6 million upfront and the remaining $14 million in installments through Fiscal Year 2024), with the potential for up to an additional $80 million from sales milestones. Corporate Updates In May 2023, the Company entered into a common stock purchase agreement (Agreement) with Lincoln Park Capital Fund (LPC). Under the terms of the Agreement, LPC has committed to purchase up to $100 million of Veru’s common stock at Veru’s sole discretion from time to time over a 36-month period. Second Quarter Financial Summary: Fiscal 2023 vs Fiscal 2022 Net revenues decreased to $6.6 million from $13.0 million Gross profit decreased to $4.1 million from $11.2 million Research and development expenses increased to $22.9 million from $15.5 million Selling, general and administrative expenses increased to $12.8 million from $7.4 million Operating loss, which included an impairment charge of $3.9 million and a provision for credit losses of $3.9 million, was $39.4 million versus $11.8 million Net loss was $38.8 million, or $0.48 per share, compared to $14.2 million, or $0.18 per share Year-to-Date Financial Summary: Fiscal 2023 vs Fiscal 2022 ​​​​​Net revenues decreased to $9.1 million from $27.2 million Gross profit decreased to $4.8 million from $23.0 million Research and development expenses increased to $41.6 million from $25.6 million Selling, general and administrative expenses increased to $30.4 million from $14.1 million Operating loss, which included an impairment charge of $3.9 million and a provision for credit losses of $3.9 million, was $75.0 million versus $16.7 million Net loss was $75.6 million, or $0.94 per share, compared to $20.6 million, or $0.26 per share. The net loss for the Company increased by $55 million for the current period. The main reason for the increase in the net loss relates to the Company preparing for the potential launch of sabizabulin for COVID-19 in the U.S. and outside the U.S. This required building a commercial team, engaging vendors to assist with the commercial launch, and manufacturing drug product for the launch upon EUA approval as required by the FDA. Since the declination, the majority of the employees hired for the commercial team have been terminated and the commercial launch sales and marketing related vendor contracts have been cancelled. Balance Sheet Information Cash and cash equivalents were $23.5 million as of March 31, 2023 versus $80.2 million as of September 30, 2022. Subsequent to the Company’s Fiscal Year 2023 second quarter, and as previously disclosed, Frost Gamma Investments Trust acquired $5 million of Company common stock in a private placement, and the Company sold its ENTADFI product to Blue Water Biotech for $6 million upfront, $14 million in notes receivable, and up to an additional $80 million if certain ENTADFI sales milestones are achieved. Net accounts receivable were $4.2 million as of March 31, 2023 versus $3.6 million as of September 30, 2022 Event Details The audio webcast will be accessible under “Investor Kit” in the Investors page of the Company’s website at . To join the conference call via telephone, please dial 1-800-341-1602 (domestic) or 1-412-902-6706 (international) and ask to join the Veru Inc. call. An archived version of the audio webcast will be available for replay on the Company’s website for approximately three months. A telephonic replay will be available on May 11, 2023 at approximately 12:00 p.m. ET by dialing 1-877-344-7529 (domestic) or 1-412-317-0088 (international) passcode 1592419 for one week. About Veru Inc. Veru is a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of breast cancer and for SARS-CoV-2 and other viral ARDS-related diseases. Veru also has a commercial sexual health division called Urev that is comprised of the FC2 Female Condom® (internal condom), for the dual protection against unplanned pregnancy and sexually transmitted infections which is sold in the U.S. and globally. Forward-Looking Statements 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 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-only non-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 will occur and what the results of any such interim analyses will be; whether the results of such interim analyses or the completed confirmatory Phase 3 study or any other interim data will be sufficient to support a new EUA application or an NDA; 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; whether and how the Company will fund the planned Phase 3 studies of sabizabulin in influenza, pox virus and COVID-19; whether and when the Company will expand the study of sabizabulin into other ARDS indications; whether the current and future clinical development efforts of the Company, including all studies of sabizabulin in infectious disease indications and 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 The Company disclaims any intent or obligation to update these forward-looking statements. FINANCIAL SCHEDULES FOLLOW Veru Inc. Condensed Consolidated Balance Sheets (unaudited) March 31, September 30, 2023 2022 Cash and cash equivalents $ 23,498,371 $ 80,190,675 Accounts receivable, net 4,205,967 3,550,895 Inventories, net 7,665,194 8,618,944 Prepaid expenses and other current assets 7,918,745 12,408,960 Total current assets 43,288,277 104,769,474 Plant and equipment, net 1,519,789 1,185,766 Operating lease right-of-use assets 4,675,739 4,786,915 Deferred income taxes 13,070,469 12,965,985 Intangible assets, net 41,667 3,977,381 Goodwill 6,878,932 6,878,932 Other assets 778,697 1,561,564 Total assets $ 70,253,570 $ 136,126,017 Accounts payable $ 17,237,474 $ 22,003,394 Accrued research and development costs 13,786,241 9,071,503 Accrued expenses and other current liabilities 6,881,260 9,193,637 Residual royalty agreement liability, short-term portion 1,354,823 1,169,095 Total current liabilities 39,259,798 41,437,629 Residual royalty agreement liability, long-term portion 10,257,325 9,656,441 Operating lease liability, long-term portion 3,987,612 4,093,667 Other liabilities 32,933 99,644 Total liabilities 53,537,668 55,287,381 Total stockholders' equity 16,715,902 80,838,636 Total liabilities and stockholders' equity $ 70,253,570 $ 136,126,017 Veru Inc. Condensed Consolidated Statements of Operations (unaudited) Three Months Ended March 31, Six Months Ended March 31, 2023 2022 2023 2022 Net revenues $ 6,585,967 $ 13,028,394 $ 9,093,761 $ 27,163,526 Cost of sales 2,493,892 1,853,116 4,299,631 4,146,166 Gross profit 4,092,075 11,175,278 4,794,130 23,017,360 Operating expenses: Research and development 22,864,633 15,541,104 41,608,982 25,622,265 Selling, general and administrative 12,834,494 7,401,138 30,380,359 14,126,344 Provision for (recovery of) credit losses 3,911,714 (2,000 ) 3,911,714 (4,000 ) Impairment of intangible assets 3,900,000 — 3,900,000 — Total operating expenses 43,510,841 22,940,242 79,801,055 39,744,609 Operating loss (39,418,766 ) (11,764,964 ) (75,006,925 ) (16,727,249 ) Non-operating income (expenses) 559,301 (2,440,316 ) (762,997 ) (3,743,382 ) Loss before income taxes (38,859,465 ) (14,205,280 ) (75,769,922 ) (20,470,631 ) Income tax (benefit) expense (66,559 ) (27,450 ) (134,837 ) 87,205 Net loss $ (38,792,906 ) $ (14,177,830 ) $ (75,635,085 ) $ (20,557,836 ) Net loss per basic and diluted common shares outstanding $ (0.48 ) $ (0.18 ) $ (0.94 ) $ (0.26 ) Basic and diluted weighted average common shares outstanding 80,834,453 80,052,504 80,695,046 80,037,675 Veru Inc. Condensed Consolidated Statements of Cash Flows (unaudited) Six Months Ended March 31, 2023 2022 Net loss $ (75,635,085 ) $ (20,557,836 ) Adjustments to reconcile net loss to net cash used in operating activities 17,792,692 6,659,447 Changes in operating assets and liabilities (2,247,306 ) 1,293,920 Net cash used in operating activities (60,089,699 ) (12,604,469 ) Net cash (used in) provided by investing activities (427,152 ) 2,012,566 Net cash provided by financing activities 3,824,547 247,873 Net decrease in cash (56,692,304 ) (10,344,030 ) Cash at beginning of period 80,190,675 122,359,535 Cash at end of period $ 23,498,371 $ 112,015,505 Investor Contact: Samuel Fisch Executive Director, Investor Relations and Corporate Communications Email: veruinvestor@verupharma.com Media Contact: Hannah Gendel Manager, Corporate Communications Email: media@verupharma.com

Reached agreement with FDA on confirmatory Phase 3 clinical trial design in 408 subjects with primary endpoint of all-cause mortality at Day 60 Study to expand treatment population to include all WHO-4, WHO-5, and WHO-6 hospitalized adult COVID-19 patients at high risk for ARDS regardless of the presence of comorbidities Two interim efficacy analyses are planned; study may be stopped if statistical criteria are met for efficacy If confirmatory Phase 3 clinical trial meets statistical significance, Veru may consider submission of a new request for EUA and/or NDA Enrollment is expected to initiate in the second half of 2023 and the first planned interim efficacy analysis expected in 2024 MIAMI, FL, May 04, 2023 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of breast cancer and for SARS-CoV-2 and other viral ARDS-related diseases, today announced that in an April 27, 2023 meeting, the Company and FDA reached agreement on the design of the Phase 3 confirmatory COVID-19 clinical trial to evaluate sabizabulin treatment in hospitalized moderate to severe COVID-19 patients who are at high risk for acute respiratory distress syndrome (ARDS) and the path forward to submit a new Emergency Use Authorization (EUA) application and/or New Drug Application (NDA). Based on the FDA's positive feedback on the confirmatory Phase 3 clinical study design and program, the Company anticipates initiating the clinical study in the second half of 2023. Highlights from the April 27th FDA meeting FDA agreed to a confirmatory Phase 3, randomized (1:1), multicenter, global, efficacy and safety study of sabizabulin 9mg oral daily dose plus standard of care treatment versus placebo plus standard of care treatment in 408 hospitalized adult patients with moderate to severe SARS-CoV-2 infection who are at high risk for ARDS: Indication (patient population) for sabizabulin has been expanded to include all hospitalized moderate to severe COVID-19 patients: WHO-4 (passive, low flow oxygen), WHO-5 (forced, high flow oxygen), or WHO-6 (mechanical ventilation) without a requirement to have a comorbidity. Endpoints: Primary efficacy endpoint is all-cause mortality at Day 60 Secondary endpoints include Days in the hospital, Days in the ICU, Days on mechanical ventilation, and proportion of patients alive without respiratory failure Exploratory endpoint is the presence of long COVID-19 symptoms at Day 180 In order to get a potentially efficacious drug to patients in an efficient time frame, two interim efficacy analyses are planned: the first planned interim analysis is expected to occur when 50% of patients (204) have completed the Day 60 primary efficacy endpoint as recommended by FDA, and the second planned interim analysis is expected to occur when 71% of patients (290) have completed the Day 60 primary efficacy endpoint. If either planned interim efficacy analysis meets statistical significance criteria, the trial could be stopped. Should the pre-specified primary efficacy endpoint analysis demonstrate a statistically significant effect on all-cause mortality favoring sabizabulin – the Company may consider a new request for an EUA and/or a submission of an NDA, as the Company would have two adequate and well controlled trials demonstrating efficacy. As the program has FDA Fast Track designation, a rolling NDA submission is a possibility for sabizabulin. The Phase 3 confirmatory COVID-19 clinical trial is expected to begin enrolling in the second half of 2023, and the first planned interim efficacy analysis is anticipated to be conducted in 2024. "While we remain confident that the efficacy and safety data already generated on sabizabulin for the treatment of hospitalized patients with moderate to severe COVID-19 infection qualifies for an emergency use authorization, it is important to continue the development toward full approval and obtaining regulatory clarity on the design of our confirmatory Phase 3 clinical study and a path forward for a new EUA and/or NDA submission is the important first step,” said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru. “We look forward to expanding the clinical development of sabizabulin into a broader group of hospitalized patients at high risk for ARDS. ARDS is the leading cause of COVID-19 related deaths. Endemic COVID-19 infections still result in an unacceptably high death rate of 4,500 U.S. deaths a month and average of 4,200 hospitalizations a day in spite of vaccines and current standard of care treatments. Furthermore, a new highly contagious COVID-19 strain, Arcturus, has emerged and is being carefully monitored. As for other viral causes of ARDS, we recently shared in preclinical studies that sabizabulin had efficacy in ARDS caused by influenza H1N1 and demonstrated antiviral activity against Vaccinia pox virus. We believe sabizabulin could emerge as the leading treatment option for hospitalized patients at high risk for viral associated ARDS broadly." About Veru Inc. Veru is a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of breast cancer and for SARS-CoV-2 and other viral ARDS-related diseases. Oncology program focuses on breast cancer The Company’s late stage breast cancer development portfolio comprises enobosarm, a selective androgen receptor targeting agonist. Enrolling Phase 2b/3 ENABLAR-2 study of enobosarm + abemaciclib (a CDK 4/6 inhibitor) combination in AR+ ER+ HER2- metastatic breast cancer (second-line metastatic setting). The Company and Eli Lilly and Company have entered into a clinical study collaboration and supply agreement for the ENABLAR-2 study. Lilly will supply Verzenio® (abemaciclib). Planned Phase 2b/3 study of enobosarm in nonmeasurable bone only metastatic breast cancer. Infectious disease program focuses on viruses that pose serious worldwide global threat COVID-19: Sabizabulin is an oral, first-in-class, new chemical entity, microtubule disruptor that has dual anti-inflammatory and host mediated antiviral properties. Veru has conducted a positive double-blind, randomized, placebo-controlled Phase 3 COVID-19 clinical trial in 204 hospitalized moderate to severe COVID-19 patients at high risk for ARDS and death. The primary endpoint was the proportion of deaths by Day 60. Treatment with sabizabulin resulted in a clinically meaningful and statistically significant 51.6% relative reduction in deaths (p=0.0046) and was well tolerated. FDA granted Fast Track designation to the Company’s COVID-19 program in January 2022. The Company is planning to conduct a Phase 3 confirmatory clinical trial to evaluate sabizabulin in hospitalized moderate to severe COVID-19 patients at high risk for ARDS. Smallpox and Ebola viruses: The Company is planning a pre-IND meeting with FDA to discuss the development of sabizabulin for smallpox virus and Ebola virus under the Animal Rules FDA regulatory approval pathway. Influenza: The Company is planning a Phase 3 clinical trial to evaluate sabizabulin in hospitalized influenza patients at high risk for ARDS. Sexual health program – Urev Veru has a commercial sexual health division called Urev that is comprised of: FC2 Female Condom® (internal condom), for the dual protection against unplanned pregnancy and the transmission of sexually transmitted infections which is sold in the U.S. and globally. Forward-Looking Statements 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 and scope of the planned confirmatory Phase 3 study of sabizabulin for certain COVID-19 patients; whether the confirmatory Phase 3 study will meet any of its primary or secondary endpoints and whether any of its exploratory endpoints will yield useful data; whether and when any of the planned interim analyses in this new Phase 3 study will occur and what the results of any such interim analyses will be; whether the results of the interim analyses or the completed Phase 3 study or any other interim data will be sufficient to support a new EUA application or an NDA; whether and when any potential EUA or NDA would be grated; whether the Company’s clinical programs for enobosarm or sabizabulin will yield Phase 3 clinical trial data in 2024; whether and when the Company will meet with BARDA regarding any potential partnering opportunities and whether those efforts will be successful; whether and how the Company will fund the planned Phase 3 studies of sabizabulin in influenza pox virus and COVID-19; whether and when the Company will expand the study of sabizabulin into other ARDS indications; whether the current and future clinical development efforts of the Company, including all studies of sabizabulin in infectious disease indications and 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 telemedicine customers for FC2 will return to historical ordering patterns or increase their purchases of FC2 at all; 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 The Company disclaims any intent or obligation to update these forward-looking statements. Investor Contact: Samuel Fisch Executive Director, Investor Relations and Corporate Communications Email: veruinvestor@verupharma.com Media Contact: Hannah Gendel Manager, Corporate Communications Email: media@verupharma.com

MIAMI, FL, May 03, 2023 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of breast cancer and for SARS-CoV-2 and other viral ARDS-related diseases, today announced that it has entered into a common stock purchase agreement (Agreement) for the purchase of up to $100 million with Lincoln Park Capital Fund (LPC), a Chicago-based institutional investor. Under the terms of the Agreement, LPC has committed to purchase up to $100 million of Veru’s common stock at Veru’s sole discretion from time to time over a 36-month period. Veru controls the timing and amount of any future sales of its shares and LPC is obligated to make purchases in accordance with the terms of the Agreement, subject to various limitations contained in the Agreement, including those under the Nasdaq listing rules. The purchase price for the Company’s common stock is set forth in the Agreement and is generally based on the prevailing market prices at the time of each sale to LPC. There are no upper limits to the price per share LPC may pay and LPC has agreed not to enter into or effect any direct or indirect short selling or hedging of Veru’s common stock. No warrants are being issued in this transaction and the Agreement does not contain any rights of first refusal, participation rights, penalties, or liquidated damages provisions in favor of any party. "We are pleased to enter into this transaction with LPC and believe that this agreement allows us to access capital in a very efficient manner," said Mitchell Steiner, M.D., Chairman, President and Chief Executive Officer of Veru. “We believe this purchase commitment further enhances our financial flexibility and is aligned with our long-term strategy for shareholder value creation. We intend to use any net proceeds from the sale of our common stock to LPC for working capital and for general corporate purposes, and to advance our most important drug candidates, enobosarm for 2nd line AR+ ER+ HER2- metastatic breast cancer and sabizabulin for SARS-CoV-2 viral ARDS, that could yield Phase 3 clinical trial data in 2024.” Additional information regarding the purchase agreement is set forth in a Current Report on Form 8-K, which Veru will file with the Securities and Exchange Commission (SEC). The securities described above are being offered by the Company pursuant to a shelf registration statement on Form S-3 (File No. 333-270606) filed with the SEC on March 16, 2023 and declared effective on April 14, 2023. The offering of the securities described herein will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the securities being offered will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC's website at http://www.sec.gov or by request from Veru Inc. at 2916 N. Miami Ave., Suite 1000, Miami, FL 33127. About Veru Inc.Veru is a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of breast cancer and for SARS-CoV-2 and other viral ARDS-related diseases. Oncology program focuses on breast cancer The Company’s late-stage breast cancer development portfolio comprises enobosarm, a selective androgen receptor targeting agonist. Enrolling Phase 2b/3 ENABLAR-2 study of enobosarm + abemaciclib (a CDK 4/6 inhibitor) combination in AR+ ER+ HER2- metastatic breast cancer (second-line metastatic setting). The Company and Eli Lilly and Company have entered into a clinical study collaboration and supply agreement for the ENABLAR-2 study. Lilly will supply Verzenio® (abemaciclib). Planned Phase 2b/3 study of enobosarm in nonmeasurable bone only metastatic breast cancer. Infectious disease program focuses on viruses that pose serious worldwide global threat COVID-19: Sabizabulin is an oral, first-in-class, new chemical entity, microtubule disruptor that has dual anti-inflammatory and host mediated antiviral properties. Veru has conducted a positive double-blind, randomized, placebo-controlled Phase 3 COVID-19 clinical trial in 204 hospitalized moderate to severe COVID-19 patients at high risk for ARDS and death. The primary endpoint was the proportion of deaths by Day 60. Treatment with sabizabulin resulted in a clinically meaningful and statistically significant 51.6% relative reduction in deaths (p=0.0046) and was well tolerated. FDA granted Fast Track designation to the Company’s COVID-19 program in January 2022. The Company is planning to conduct a Phase 3 confirmatory clinical trial to evaluate sabizabulin in hospitalized moderate to severe COVID-19 patients at high risk for ARDS. Smallpox and Ebola viruses: The Company is planning a pre-IND meeting with FDA to discuss the development of sabizabulin for smallpox virus and Ebola virus under the Animal Rules FDA regulatory approval pathway. Influenza: The Company is planning a Phase 3 clinical trial to evaluate sabizabulin in hospitalized influenza patients at high risk for ARDS. Sexual health program – Urev Veru has a commercial sexual health division called Urev that is comprised of: FC2 Female Condom® (internal condom), for the dual protection against unplanned pregnancy and the transmission of sexually transmitted infections which is sold in the U.S. and globally. Forward-Looking StatementsThe 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 timing, pricing and size of any potential purchases by LPC under the Agreement, including the aggregate amounts eventually issued by the Company thereunder; whether the funding pursuant to the LPC Agreement will be sufficient to fund the Company’s working capital, general corporate and research and development needs, including the planned studies of sabizabulin in COVID, influenza and pox virus and the late stage enobosarm studies in certain breast cancers; whether and when the Company will expand the study of sabizabulin into other ARDS indications; whether the current and future clinical development efforts of the Company, including all studies of sabizabulin in infectious disease indications and 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; the expected use of any proceeds from sales of shares pursuant to the Agreement; and whether the Company’s current cash and capital resources, including sales of common stock pursuant to the Agreement, 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 FC2 product 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. Investor Contact: Samuel FischExecutive Director, Investor Relations and Corporate CommunicationsEmail: veruinvestor@verupharma.com Media Contact:Hannah GendelManager, Corporate CommunicationsEmail: media@verupharma.com