SERD/MEK inhibitor(Baylor College of Medicine)

点击蓝字关注我们本周，审评审批方面，除了有生物类似药、5.1类化药获批外，还有多个创新药新适应症获批，但最值得关注的是，齐鲁制药1类新药伊鲁阿克片获批上市；研发方面，进展不多，但elafibranor治疗原发性胆汁性胆管炎（PBC）Ⅲ期结果积极；交易及投融资方面，荣昌和信达达成临床合作协议；上市方面，来凯医药港交所上市。本周盘点包括审评审批、研发、交易及投融资和上市4大板块，统计时间为6.26-6.30，包含29条信息。 审评审批NMPA上市批准       1、6月26日，NMPA官网显示，阿斯利康5.1类化药达格列净二甲双胍缓释片（商品名：XigduoXR）获批上市，用于治疗2型糖尿病。XigduoXR是SGLT2抑制剂/盐酸二甲双胍缓释片复方制剂，2014年10月获FDA批准上市，还有一个适应症为2型糖尿病合并中度肾功能损害（肾小球滤过率[eGFR]估计为45-59mL/min/1.73m2的慢性肾脏疾病。2、6月26日，NMPA官网显示，恒瑞医药1类化药羟乙磺酸达尔西利片（研发代号：SHR6390）新适应症获批，联合芳香化酶抑制剂作为初始治疗，治疗HR阳性、HER2阴性局部晚期或转移性乳腺癌。该药是恒瑞自主研发的口服、高效、选择性小分子CDK4/6抑制剂，2021年12月在国内上市，联合氟维司群用于激素受体（HR）阳性、人表皮生长因子受体2（HER2）阴性的经内分泌治疗后进展的复发或转移性乳腺癌。3、6月26日，NMPA官网显示，基石药业1类化药普拉替尼胶囊（商品名：普吉华）新适应症获批，用于一线治疗转染重排（RET）基因融合阳性的局部晚期或转移性非小细胞肺癌（NSCLC）患者。普拉替尼是Blueprint开发的一种口服、每日1次、强效高选择性RET抑制剂。2018年6月，基石药业获得该产品在大中华地区的独家开发和商业化权利。4、6月26日，NMPA官网显示，复星凯特3类治疗用生物制品阿基仑赛注射液（商品名：奕凯达）新适应症获批，用于一线免疫化疗无效或在一线免疫化疗后12个月内复发的成人大B细胞淋巴瘤（r/rLBCL）。阿基仑赛注射液是吉利德/Kite开发的靶向CD19的基因修饰自体CAR-T细胞注射液，2017年，复星凯特获得全部技术授权。5、6月26日，NMPA官网显示，梯瓦5.1类化药醋酸格拉替雷注射液获批上市，用于治疗多发性硬化症。醋酸格拉替雷是一种由四种氨基酸 (谷氨酸、赖氨酸、丙氨酸和酪氨酸) 组成的肽段共聚物混合物。该药物最早于1996年获得FDA批准上市，有20mg和40mg两种版本，前者需每日注射，后者需每周注射3次。6、6月28日，NMPA官网显示，齐鲁制药1类化药伊鲁阿克片（曾用名：依鲁奥克，研发代号：WX-0593）获批上市，用于既往接受过克唑替尼治疗后疾病进展或对克唑替尼不耐受的间变性淋巴瘤激酶（ALK）阳性的局部晚期或转移性非小细胞肺癌（NSCLC）患者的治疗。伊鲁阿克是其研发的一款新型ALK/ROS1抑制剂。7、6月29日，NMPA官网显示，正大天晴3类化药芦比前列酮软胶囊获批上市，成为首仿。鲁比前列酮（即芦比前列酮）为一种促分泌药物，作用于肠道上皮的2型氯离子通道，通过促进肠液的分泌和加快肠道的转运来改善便秘症状。该药已在国外获批超10年，获批适应证包括慢性特发性便秘和便秘型肠易激综合征。8、6月29日，NMPA官网显示，亿腾医药5.1类化药芦曲泊帕片（商品名：稳可达）获批上市，用于计划接受手术（含诊断性操作）的慢性肝病伴血小板减少症的成人患者。芦曲泊帕是一种口服的、小分子的人血小板生成素受体激动剂，已被批准在美国、欧盟和日本上市。2019年6月，亿腾医药与盐野义达成合作，获得芦曲泊帕在中国大陆、香港和澳门地区的独家授权。9、6月29日，NMPA官网显示，神州细胞3.3类治疗用生物制品贝伐珠单抗注射液获批上市。贝伐珠单抗原研由罗氏开发，于2004年在美国上市，2010年在中国上市，获批的适应症覆盖肝细胞癌、非小细胞肺癌、结直肠癌、宫颈癌和卵巢癌等。10、6月29日，NMPA官网显示，锐康迪医药5.1类化药卡谷氨酸分散片获批上市，用于治疗由多种因素引起的成人及儿童患者高氨血症。卡谷氨酸分散片是Recordati Rare Diseases的一款血液疾病治疗药物，其有效成分卡谷氨酸是一个合成的N-乙酰谷氨酸（NAG）结构类似物。 申请11、6月27日，CDE官网显示，Daewoong5.1类化药盐酸非苏拉生片（fexuprazan）递交上市申请并获受理。非苏拉生是一款新型钾离子竞争性酸阻滞剂（P-CAB）、新一代质子泵抑制剂（PPI），2021年3月，扬子江药业子公司海尼药业获得国内权益，负责其在中国的临床开发和审批程序，扬子江药业负责整个市场销售。12、6月28日，CDE官网显示，先声药业与宁丹新药合作开发的2.2类化药依达拉奉右莰醇舌下片递交上市申请并获受理，用于改善急性缺血性脑卒中（AIS）所致的神经症状、日常活动能力和神经功能障碍。依达拉奉右莰醇舌下片所含的依达拉奉和右莰醇两种活性成分可在崩解后迅速释放，通过静脉丛吸收进入血液，避免通过消化道吸收产生的首过效应。13、6月29日，CDE官网显示，阿斯利康3.1类治疗用生物制品本瑞利珠单抗（benralizumab）注射液递交上市申请并获受理。Benralizumab是一款IL-5Rα单抗，最初由协和麒麟开发，2019年3月，阿斯利康与协和麒麟达成新的许可协议，获得benralizumab在亚洲地区的开发和商业化权益以及全球商业化权益。14、6月29日，CDE官网显示，琅铧医药5.1类化药盐酸替洛利生片（Pitolisant）递交上市申请并获受理，用于治疗发作性睡病青少年和6岁以上儿童患者的日间过度嗜睡（EDS）或猝倒。该药由Bioprojet研发，是一款first-in-class选择性组胺3（H3）受体拮抗剂/反向激动剂。临床批准       15、6月28日，CDE官网显示，礼来1类化药LY3502970胶囊（Orforglipron）获批临床，用于减重。LY3502970胶囊是一款新型、高效、每日1次的口服小分子GLP-1R激动剂，最初由Chugai开发。2018年9月，礼来与Chugai达成协议，获得LY3502970的全球开发和商业化权益。16、6月28日，CDE官网显示，四川至善唯新1类治疗用生物制品ZS802注射液获批临床。ZS802作为一种至善唯新原研的rAAV基因药物，用于治疗A型血友病。ZS802使用至善唯新自主研发的全球最小肝脏特异启动子，解决了病毒载体包装难题，显著提高药物质量。17、6月29日，CDE官网显示，信达细胞1类治疗用生物制品IBI346获批临床，拟开发治疗复发/难治多发性骨髓瘤。IBI346是信达生物、信达细胞利用罗氏的细胞技术平台开发的新一代CAR-T细胞治疗药物。该药物包括两个部分：P329G BCMA抗体和P329G CAR-T细胞。   申请18、6月27日，CDE官网显示，康方生物1类治疗用生物制品AK131注射液递交临床试验申请。AK131是由康方生物自主研发的靶向PD-1/CD73的双特异性抗体，由PD-1单抗AK105和CD73单抗AK119衍生而来。这是全球首款申报临床的PD-1/CD73双抗。FDA上市      批准19、6月27日，FDA官网显示，优时比（UCB）皮下注射靶向新生儿Fc受体（FcRn）单抗Rozanolixizumab(商品名：Rystiggo）获批上市，用于治疗抗乙酰胆碱受体（AChR）或抗肌肉特异性酪氨酸激酶（MuSK）抗体阳性成人全身型重症肌无力（gMG）。20、6月28日，FDA官网显示，CellTrans同种异体胰岛细胞疗法Lantidra获批上市，用于治疗1型糖尿病成人患者。这些患者尽管已经进行了糖尿病治疗和教育，但由于反复发生严重低血糖，无法达到目标糖化血红蛋白水平。Lantidra通过输注同种异体胰岛β细胞分泌胰岛素来发挥治疗作用。申请21、6月27日，FDA官网显示，Verona Pharma递交恩塞芬汀（ensifentrine）新药上市申请（NDA），用于维持治疗慢性阻塞性肺病（COPD）。该药是Verona开发的一种吸入式磷酸二酯酶3/4（PDE3/4）抑制剂，2021年6月，优锐医药与Verona达成协议，以可能高达2.19亿美元的总交易额（首付款2500万美元）获得该产品在大中华区域的开发和商业化权益。临床    批准22、6月28日，FDA官网显示，君实生物抗BTLA单抗Tifcemalimab（研发代号：TAB004/JS004）联合PD-1单抗特瑞普利单抗作为局限期小细胞肺癌（LS-SCLC）放化疗后未进展患者的巩固治疗的随机、双盲、安慰剂对照、国际多中心Ⅲ期临床研究（JS004-008-Ⅲ-SCLC研究）获批。该研究将是全球首个BTLA单抗联合PD-1的国际多中心Ⅲ期研究。快速通道资格23、6月27日，FDA官网显示，AC Immune在研Aβ疫苗ACI-24.060获得快速通道资格认定，用于治疗阿尔兹海默病（AD）。ACI-24.060是基于AC Immune公司SupraAntigen平台开发的抗Aβ疫苗，旨在促进与针对驱动淀粉样蛋白沉积和AD疾病进展的Aβ产生抗体反应。ACI-24.060具有抑制Aβ形成的潜力，以达到延缓或预防AD进展的治疗效果。研发临床状态24、6月27日，药物临床试验登记与信息公示平台显示，丽珠和鑫康合生物启动了一项Ⅲ期临床试验，旨在评估LZM012对比司库奇尤单抗（商品名：可善挺）治疗中度至重度慢性斑块状银屑病的有效性和安全性。LZM012是丽珠医药自鑫康合生物引进的一款IL-17A/IL-17F单抗。临床数据25、6月27日，赛诺菲宣布，治疗中重度特应性皮炎的Ⅱb期STREAM-AD研究达到了改善EASI评分的主要终点和关键次要终点。Amlitelimab最初由Kymab研发，是一款全人源的OX40L单抗。2021年11月，赛诺菲以14.5亿美元的价格收购了Kymab以将该药物收入囊中。26、6月30日，Ipsen和Genfit联合公布了elafibranor治疗原发性胆汁性胆管炎（PBC）Ⅲ期ELATIVE研究积极结果。结果显示，elafibranor治疗组中，51%的患者实现了胆汁淤积缓解，而安慰剂组为4% (p<0.0001)，主要终点达到了统计学上的显著改善。Elafibranor是一种PPARα和PPARδ的双重激动剂。交易及投融资27、6月26日，荣昌生物宣布，与信达生物达成一项临床研究和供药合作协议。根据合作协议，信达生物提供PD-1单抗信迪利单抗注射液，荣昌生物将在中国开展临床I/Ⅱa期研究，评估ADC药物RC88（靶向MSLN）或RC108（靶向c-MET）联合信迪利单抗注射液在中国肿瘤患者中的安全性、耐受性和初步疗效。28、6月30日，卫材宣布，与DRI Healthcare达成一项协议。根据合作协议，将艾拉司群（Elacestrant）的所有未来经济权益转让给后者。艾拉司群是FDA批准的首款口服选择性雌激素受体降解剂（SERD）。上市港交所29、6月29日，来凯医药正式在港交所上市。目前，来凯医药在研管线拥有2款核心产品及14种其它管线候选产品，覆盖癌症、肝纤维化、罕见病等疾病领域。其中，核心产品LAE002有望于2023年第四季度在中国和美国递交新药上市申请（NDA）。【企业推荐】智药研习社近期课程报名来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多制药资讯，请关注CPHI制药在线▼点击阅读原文，进入智药研习社~

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