更新于：2023-11-16
Zuclomifene(Veru Healthcare, Inc.)
珠氯米芬
更新于：2023-11-16
概要
基本信息
药物类型 小分子化药 |
别名 2-(4-(2-chloro-1,2-diphenylethenyl)phenoxy)-N,N-diethylethanamine、2-(p-(2-chloro-1,2-diphenylvinyl)phenoxy)triethylamine、2-(p-(β-chloro-α-phenylstyryl)phenoxy)triethylamine + [10] |
靶点 ER(雌激素受体家族) |
作用机制 ERs激动剂(雌激素受体家族激动剂) |
治疗领域 肿瘤、免疫系统疾病、神经系统疾病+ [3] |
在研适应症 前列腺癌、潮热、弥漫内生性脑桥神经胶质瘤+ [2] |
非在研适应症- |
非在研机构- |
最高研发阶段临床2期 |
首次获批日期(全球)- |
最高研发阶段(中国)- |
特殊审评- |
结构
分子式C26H28ClNO.C6H8O7 |
InChIKeyPYTMYKVIJXPNBD-OQKDUQJOSA-N |
CAS号7619-53-6 |
关联
20
项与 珠氯米芬 相关的临床试验Impact of clomiphene on semen parameters in normogonadotrophic idiopathic male infertility: a double-blind randomised placebo-controlled trial
开始日期2023-11-01 |
The optimized clinical trial of PPOS regimen in PCOS patients
开始日期2022-11-14 |
申办/合作机构- |
Comparison of the effect of three drugs clomiphene, letrozole and gonadotropin on the dominant follicle and pregnancy in infertile women with polycystic ovaries: a single-blind randomized controlled trial
开始日期2022-04-04 |
100 项与 珠氯米芬 相关的临床结果
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100 项与 珠氯米芬 相关的专利（医药）
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2,566
项与 珠氯米芬 相关的文献（医药）2023-10-09·Ugeskrift for laeger
Review
作者: Emilie Steentoft Dahlberg ; Dorte Andersen ; Pernilla Skjødt Andersson ; Kathrine Birch ; Lotte Colmon ; Marianne Dreyer Holt ; Kasper Ingerslev ; Kirstine Kirkegaard ; Kristine Løssl ; Liv la Cour Poulsen ; Marie-Louise Wissing ; Mathilde Yde ; Nathalie Søderhamn Bülow
This review describes the current evidence regarding the putative indications of letrozole (LTZ) in fertility treatment. Prior to intrauterine insemination, LTZ is recommended in women with normogonadotrophic oligo-anovulation. In ovulatory women, LTZ is equal to clomiphene and may be used instead of exogenous gonadotrophin. LTZ may be used as co-treatment in poor responders prior to in vitro fertilization/intracytoplasmic sperm injection. In addition, LTZ prior to frozen-thawed embryo transfer is increasingly used in women with normogonadotrophic oligo-anovulation.
2023-10-06·European journal of obstetrics, gynecology, and reproductive biology
Retraction notice to "Adding l-carnitine to clomiphene resistant PCOS women improves the quality of ovulation and the pregnancy rate. A randomized clinical trial" [Eur. J. Obstet. Gynecol. Reprod. Biol. 180 (2014) 148-152].
Article
作者: Alaa M Ismail ; Ali Hassan Hamed ; Srdjan Saso ; Hossam H Thabet
2023-09-15·Rapid communications in mass spectrometry : RCM
Identification and synthesis of (Z)-3′-hydroxy clomiphene as a new potential doping-relevant metabolite of clomiphene
Article
作者: Euler, Luisa ; Muerdter, Thomas ; Heinkele, Georg ; Schwab, Matthias ; Miller, Geoffrey D. ; Eichner, Daniel ; Thomas, Andreas ; Thevis, Mario
A recent study addressed the possibility of unintentional ingestion of clomiphene through residues in chicken eggs. The method developed here helped distinguish between microdose intake of (E/Z)-clomiphene citrate and consumption of clomiphene-containing eggs by the urinary pattern of four mono-hydroxylated clomiphene metabolites. However, reanalyses of doping-control samples, which showed an adverse analytical finding for clomiphene, revealed a hydroxy clomiphene (HC) isomer that was not found after microdose intake or after consumption of clomiphene-containing eggs and could not be assigned to any of the available reference compounds. The aim of the present follow-up study was to identify this HC isomer and to characterize this metabolite with respect to its potential properties as long-term metabolite in doping controls.
METHODS:
(E/Z)-3'-HC and (E/Z)-4'-HC were synthesized involving the McMurry reaction. An ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method was developed and optimized after a derivatization step with dansyl chloride to separate eight HC isomers. Using this method, urine samples from a controlled clomiphene administration study were analyzed, in which male study participants received therapeutic doses of clomiphene for 30 days and collected urine samples for up to 8 months. Thus, isomer-specific HC elimination profiles could be monitored.
RESULTS:
The metabolite previously found in doping-control samples was identified as (Z)-3'-HC. The elimination profiles of the different HCs confirmed previous results, with (Z)-3-HC being the most abundant urinary hydroxy metabolite shortly after administration. A new finding was that the data suggest that (Z)-3'-HC is excreted at higher relative concentrations only several weeks after drug intake.
CONCLUSION:
These findings might be of particular importance in sport drug testing as they can assist in the decision-making process to distinguish between intentional doping and inadvertent exposure to clomiphene via food contamination.
36
项与 珠氯米芬 相关的新闻（医药）2023-03-23
Credit: Shutterstock/justesfir
Polycystic ovarian syndrome (PCOS), sometimes known as polycystic ovarian disease (PCOD), is a common endocrine disorder experienced by approximately 5 to 13% of people of reproductive age worldwide. While lifestyle modifications play a key role in treating PCOS, the paucity of new treatments signal a need for breakthrough research.
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Research states that PCOS is typically characterized by hyperandrogenism, high levels of androgens; ovulatory dysfunction; and polycystic ovaries. Scientific research and a better understanding of the condition is driving new developments in medications. ”The condition’s symptoms are not homogeneous, and that makes drug development complicated,” Javier Szwarcberg, CEO of Spruce Biosciences, a rare disease company researching endocrine disorders, says.
A growing body of research also highlights the condition’s impact on quality of life and mental wellbeing. It is associated with insulin resistance (IR), metabolic syndrome (MS), low-grade chronic inflammation, and an increased risk of non-alcoholic fatty liver disease.
Unmet need for PCOS medications
With limited research comes the perception that for decades, the pharmaceutical armamentarium for PCOS has been restricted to a handful of standard drugs. Hormonal contraceptives, and other drugs like clomiphene, eflornithine have been reported to ameliorate symptoms. As per GlobalData,
practitioners typically turn to five drugs to treat PCOS
; the main drug is metformin, accounting for almost a quarter of trials (24.7%).
GlobalData is the parent company of
Pharmaceutical Technology.
Standard medications used for the disorder have also raised questions over their ability to meet the condition’s heterogeneous nature. “There is definitely an unmet need… When you talk to PCOS patients, the therapies they take don’t fully address their disease,” details Szwarcberg.
While the number of new investigational therapies specifically designed to treat PCOS is scant, some companies continue to repurpose hormonal medications. Florham Park, New Jersey-based Exeltis Pharmaceuticals
is currently running a Phase III study (EudraCT-2021-002178-17) with LPRI-421, a fixed dose combination of dienogest, a synthetic progesterone, and ethinylestradiol, a synthetic estrogen.
Current treatment options mainly address symptoms such as hyperandrogenemia, irregular menstruation, and infertility, and therefore support patients with functional ovarian hyperandrogenism (FOH), which is estimated to affect around 62% of patients with PCOS. With tildacerfont, Spruce aims to target PCOS patients with mixed pathology and primary functional adrenal hyperandrogenism (FAH), which are collectively experienced by approximately 30% of patients who have exaggerated levels of dehydroepiandrosterone sulphate (DHEAS), a type of androgen. A 2019 study has revealed that androgens play a key role in regulating female fertility and androgen receptors are prevalent in the origins of the condition.
Spruce is currently studying the safety and efficacy of tildacerfont in a Phase II study (NCT05370521) in participants ages 18–40 years with PCOS and elevated adrenal androgens. The study’s results are anticipated for release in mid-2023.
The idea that high adrenal androgen levels in women with PCOS could also be related to an increase in corticotropin (ACTH), a hormone released by the pituitary gland, has long been explored in this space. Using tildacerfont, which also acts as a modulator of ACTH release, Spruce aims to determine if modulating the amount of ACTH regulates the amount of adrenal androgens present in the context of PCOS. Research indicates that increased adrenal androgen production can result in cystic acne, hirsutism, male-type baldness, menstrual irregularities, oligoovulation or anovulation, infertility, and/or frank virilization.
Conventional therapies don’t often address the management of hyperandrogenemia in the context of PCOS patients, says Szwarcberg. “We believe this study will provide information around biology and create the foundations by which a program can then be built around the potential benefits in hyperandrogenemia control.”
Other novel therapeutic modalities for the management of PCOS include the use of newer insulin sensitizers viz, glucagon-like peptide-1(GLP-1) agonists, dipeptidyl peptidase-4 (DPP-4) inhibitors, and sodium-glucose transport protein 2 (SGLT2) inhibitors, says Sayeed Akhtar, PhD, assistant professor, Department of Clinical Pharmacy at King Khalid University, Abha, Saudi Arabia.
A research study
found that
Novartis’s
aromatase inhibitor Femara (letrozole) currently appears to be more effective than clomiphene citrate, a common reference drug, in treating infertility caused by PCOS. The incidence of infertility in women with this condition varies between 70–80%, research has found.
Managing PCOS symptoms
The heterogeneous nature of metabolic and endocrine disorders is a key factor influencing the health sector’s ability to advise and provide specific guidance for managing PCOS. US educational platform Uterinekind has teamed up with the Cornell Ovary Lab to fund research on the condition and has developed an app to help people access resources and support their uterine health.
Global healthcare better supports patients in managing their symptoms by “managing the different facets of issues developed due to PCOS”, says Akhtar. Making lifestyle changes is often the first line of treatment before the addition of an insulin-sensitizing drug may be advised.
More research is needed. “[PCOS] is a difficult disease to address and I don’t see many companies investing time in finding more advanced treatments for PCOS patients,” says Szwarcberg. Commenting on why there is so little research despite the high incidence, Akhtar says this is due to “less focus on policy and funding”.
A
2021 UK parliamentary discussion on PCOS
and endometriosis stated it did not have plans to increase near-term funding,
despite calls for support
. Rather, it expressed the importance of increasing awareness and opening an important dialogue on PCOS.
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临床2期临床3期
2023-03-15
Pictured: FDA sign in front of building/Courtesy Sarah Silbiger/Getty Images
Weeks after the FDA rejected Veru’s Emergency Use Authorization (EUA) bid for sabizabulin in COVID-19, the company announced plans to continue with late-stage development of the drug.
Veru will conduct a Phase III study of sabizabulin in hospitalized patients with moderate to severe COVID-19 who are at high risk of developing acute respiratory disease syndrome (ARDS). The drug will also enter a Phase III study in hospitalized influenza patients at risk of ARDS.
This announcement in an SEC filing posted Tuesday comes almost two weeks after the FDA turned down sabizabulin’s EUA. On Mar. 2, the company said the regulator rejected the application but remained open to working with Veru on the drug’s development.
Concurrent with the rejection, the regulator also provided feedback on Veru’s proposed protocol for a confirmatory Phase III study for sabizabulin, stating that the company should provide “appropriate time frames for interim analyses.” This will allow Veru to end the trial promptly “should a strong efficacy signal again be observed,” according to the FDA.
This confirmatory trial could potentially support a new EUA bid or a New Drug Application approval for sabizabulin, according to Veru’s announcement.
Sabizabulin is an investigational oral microtubule disruptor that binds to a protein called tubulin, an integral part of the cell’s cytoskeleton. In COVID-19, sabizabulin inhibits the transport of viral particles within the cells and stops the virus from replicating and assembling itself.
This mechanism of action also has therapeutic potential in cancer because it disables the formation of the mitotic spindle, preventing the uncontrolled division of tumor cells.
However, in Monday’s SEC filing, Veru also announced it was limiting sabizabulin’s clinical development to only infectious disease indications. As a result, it’s discontinuing the Phase III VERACITY study, intended to evaluate the drug in certain prostate cancers.
Cost-Cutting and Realignment
Along with its plans to pursue Phase III in COVID-19, Veru announced Monday initiatives to “refocus its drug development efforts on those drug candidates” most likely to yield “long-term success.”
The company is also implementing cost-cutting measures to conserve cash, including “a reduction in personnel,” the SEC filing read.
As for its pipeline, Veru is also updating a Phase III study of its enobosarm, a selective androgen receptor agonist, in combination with abemaciclib, a CDK 4/6 inhibitor, in specific types of metastatic breast cancer. This drug combo is being developed in partnership with Eli Lilly.
Veru is also developing enobosarm as a monotherapy in bone-only metastatic breast cancers, with a Phase II study currently planned.
Meanwhile, the company is pausing the development of Veru-100, being trialed for prostate cancer, and zuclomiphene, its candidate for hot flashes associated with androgen deprivation therapy.
临床3期临床2期紧急使用授权
2023-02-09
Sabizabulin for moderate to severe COVID-19 under review for potential emergency authorization by multiple global regulatory agencies
Presented late-breaker oral presentation at IDWeek; sabizabulin treatment resulted in 81.2% relative reduction in deaths compared to the placebo in the WHO 4 subset group
Company to host conference call and webcast today at 8:00 a.m. ET
MIAMI, FL, Feb. 09, 2023 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral ARDS-related diseases and for oncology, today announced financial results for its fiscal 2023 first quarter and provided a business update.
“We have been busy seeking emergency authorization for sabizabulin for the treatment of hospitalized moderate to severe COVID-19 patients at high risk for ARDS with major global regulatory bodies,” said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru. “Our U.S. and international commercial teams are on standby. We are actively enrolling subjects in our advanced breast and prostate cancer Phase 3 clinical studies. Further, we have put in place a multi-pronged strategy to increase revenues from our sexual health program which appears to be successful as Q2 FY 2023 sales are significantly improving. As we await regulatory decisions, we have implemented measures to prudently conserve our cash, and we will provide an update once we are able to determine our path forward.”
Infectious Disease Program Updates
Sabizabulin, a Novel OralMicrotubule Disruptor, for the Treatment of Hospitalized Moderate to Severe COVID-19 Patients at High Risk for Acute Respiratory Distress Syndrome (ARDS)
Sabizabulin for the treatment of COVID-19 is currently under regulatory review for potential emergency authorization by U.S. Food and Drug Administration (FDA), European Union’s European Medicines Agency (EMA), United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA), Australia’s Therapeutic Goods Administration (TGA), Canada’s Health Canada, South Korea’s Ministry of Food and Drug Safety (MFDS), and Switzerland’s Swissmedic. With respect to Europe, if the EMA authorizes sabizabulin for emergency use under Article 18, then individual EU nations may decide to authorize sabizabulin in their respective countries.
In October 2022, Phase 3 data of sabizabulin for the treatment of COVID-19 was presented as a late-breaker at IDWeek (Infectious Disease Week) 2022. Clinical highlights from the presentation include statistically and clinically significant reductions in mortality with sabizabulin treatment resulting in a 22.4 absolute percentage point and 81.2% relative reduction in deaths compared to the placebo (p=0.0090) in a subset analysis of hospitalized moderate to severe WHO-4 COVID-19 patients at high risk for ARDS.
Oncology Program Updates
Enobosarm, a Novel Oral Selective Androgen Receptor Targeting Agonist, and Abemaciclib, a CDK 4/6 Inhibitor, Combination Therapy for the 2nd Line Treatment of AR+ER+HER2- Metastatic Breast Cancer
Enrollment has been ongoing in the Phase 3 multicenter, open label, randomized (1:1), active control ENABLAR-2 trial to evaluate the combination of enobosarm and abemaciclib for the treatment of AR+ER+HER2- metastatic breast cancer. We have a collaboration and supply agreement with Eli Lilly and Company for this trial.
Enobosarm for the 3rd Line Treatment of AR+ER+HER2- Metastatic Breast Cancer
Enrollment has been ongoing in the Phase 3 multicenter, international, open label, randomized (1:1) ARTEST trial to evaluate enobosarm for the treatment of AR+ER+HER2- metastatic breast cancer.
Sabizabulin for the Treatment of Metastatic Castration and Androgen Receptor Targeting Agent Resistant Prostate Cancer
Enrollment has been ongoing in the Phase 3 VERACITY open label, randomized (2:1), multicenter trial to evaluate sabizabulin 32mg for the treatment of chemotherapy naïve men with metastatic castration resistant prostate cancer who have tumor progression after previously receiving at least one androgen receptor targeting agent.
VERU-100, a Novel Proprietary Long-Acting Gonadotropin-Releasing Hormone (GnRH) Antagonist Peptide 3-Month Subcutaneous Depot Formulation, for Androgen Deprivation Therapy of Advanced Prostate Cancer
Enrollment has been ongoing in the Phase 2 clinical dose finding trial to evaluate VERU-100 for the treatment of androgen deprivation therapy in patients with advanced prostate cancer.
Urev - Sexual Health Program Updates
FC2 Female Condom/Internal Condom®
The Company markets and sells the FC2 Female Condom®, an FDA-approved product for dual protection against unplanned pregnancy and the transmission of sexually transmitted infections.
ENTADFI™ (finasteride and tadalafil) capsules for oral use, a New Treatment for Benign Prostatic Hyperplasia (BPH)
The Company markets ENTADFI™, an FDA-approved oral, once daily product for benign prostatic hyperplasia (BPH) for men with an enlarged prostate experiencing the signs and symptoms of BPH for up to 26 weeks.
First Quarter Financial Summary: Fiscal 2023 vs Fiscal 2022
Net revenues decreased to $2.5 million from $14.1 million
Gross profit decreased to $0.7 million from $11.8 million
Research and development expenses increased to $18.7 million from $10.1 million
Selling, general and administrative expenses increased to $17.5 million from $6.7 million
Operating loss was $35.6 million versus $5.0 million
Net loss was $36.8 million, or $0.46 per share, compared to $6.4 million, or $0.08 per share
Balance Sheet Information
Cash and cash equivalents were $46.9 million as of December 31, 2022 versus $80.2 million as of September 30, 2022
Net accounts receivable were $3.9 million as of December 31, 2022 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 February 9, 2023 at approximately 12:00 p.m. ET by dialing 1-877-344-7529 (domestic) or 1-412-317-0088 (international) passcode 9127050 for one week.
About Veru Inc.
Veru is a biopharmaceutical company focused on developing novel medicines for COVID-19 and other viral ARDS-related diseases and for oncology. The Company’s infectious disease development program includes sabizabulin, an oral microtubule disruptor, for the treatment of hospitalized moderate to severe COVID-19 patients at high risk for acute respiratory distress syndrome (ARDS). In the final analysis of the Phase 3 trial, treatment with sabizabulin 9 mg once daily resulted in a clinically meaningful and statistically significant 51.6% relative reduction in deaths compared to placebo. Sabizabulin for COVID-19 is currently under regulatory review for potential emergency or conditional authorization by U.S. FDA, European Union’s EMA, United Kingdom’s MHRA, Australia’s TGA, Canada’s Health Canada, South Korea’s MFDS, and Switzerland’s Swissmedic.
The Company’s breast cancer development portfolio comprises enobosarm, a selective androgen receptor targeting agonist, and sabizabulin. Veru’s oncology program also includes product candidates in development for the treatment of prostate cancer: sabizabulin, VERU-100, a long-acting GnRH antagonist and zuclomiphene citrate, an oral nonsteroidal estrogen receptor agonist.
The Company’s commercial sexual health program, Urev, has 2 FDA-approved products, including 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 and ENTADFI™ (finasteride and tadalafil) capsules for oral use, a new treatment for benign prostatic hyperplasia.
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: whether the Company will successfully develop or commercialize any drug in the infectious disease area and whether any such drug will serve a potentially life-saving unmet need; whether the Company’s infections disease franchise will generate any commercially available product and whether it will expand sabizabulin or any other compound beyond the potential treatment of certain COVID-19 patients; whether and when the Company will receive an emergency use authorization or any approval from FDA or from any regulatory authority outside the U.S. for sabizabulin for certain COVID-19 patients; whether and when sabizabulin will become an available treatment option for certain COVID-19 patients in the U.S. or anywhere outside the U.S.; whether any additional efficacy or safety clinical studies of sabizabulin for certain COVID-19 patients will be required by the FDA or any other regulatory authority as a condition to any authorization or as a post-authorization requirement; whether the Company will have sufficient supply of sabizabulin or sufficient commercial resources to meet demand, if an emergency use authorization or other approval is granted in the U.S. or in any other country; whether the Company will secure any advance purchase agreement with any government; whether the current and future clinical development and results will demonstrate sufficient efficacy and safety and potential benefits to secure FDA approval of any of the Company’s other drug candidates; whether the drug candidates will be approved for the targeted line of therapy; the anticipated design and scope of clinical studies and FDA acceptance of such design and scope; whether any regulatory pathways, including the accelerated Fast Track designations, to seek FDA approval for sabizabulin, enobosarm or any of the Company’s drug candidates are or will continue to be available; whether the expected commencement and timing of the Company’s clinical studies, including the Phase 3 ENABLAR-2 study, the sabizabulin monotherapy Phase 2b clinical study for 3rd line treatment of metastatic breast cancer, and the Phase 2 registration clinical study for VERU-100 will be met; when clinical results from the ongoing clinical studies will be available, whether sabizabulin, enobosarm, VERU-100, or zuclomiphene will serve any unmet need or, what dosage, if any, might be approved for use in the U.S. or elsewhere, and also statements about the potential, timing and efficacy of the rest of the Company’s development pipeline, and the timing of the Company’s submissions to FDA and FDA’s review of all such submissions; whether ENTADFI will be commercialized successfully, the Company will grow sales of ENTADFI or the Company will be able to successful partner with any other entity to grow sales of ENTADFI; whether the telemedicine customers for FC2 will return to historical ordering patterns or increase their purchases of FC2 at all; whether the Company’s current cash will be sufficient to fund its planned or expected operations, especially if any authorizations for sabizabulin for certain COVID-19 patients are not obtained and whether the Company may need to raise capital; and whether any of the specified clinical trials will be suspended, modified or terminated as the Company seeks to conserve cash. 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; 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 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; the Company’s ability to successfully commercialize any of its products, if approved; 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; 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
FINANCIAL SCHEDULES FOLLOW
Veru Inc.
Condensed Consolidated Balance Sheets
(unaudited)
December 31,
September 30,
2022
2022
Cash and cash equivalents
$
46,927,187
$
80,190,675
Accounts receivable, net
3,864,310
3,550,895
Inventories, net
8,732,627
8,618,944
Prepaid expenses and other current assets
13,484,521
12,408,960
Total current assets
73,008,645
104,769,474
Plant and equipment, net
1,425,970
1,185,766
Operating lease right-of-use assets
4,600,783
4,786,915
Deferred income taxes
13,052,163
12,965,985
Intangible assets, net
3,959,524
3,977,381
Goodwill
6,878,932
6,878,932
Other assets
856,435
1,561,564
Total assets
$
103,782,452
$
136,126,017
Accounts payable
$
10,566,962
$
22,003,394
Accrued research and development costs
12,678,176
9,071,503
Accrued expenses and other current liabilities
15,146,618
9,193,637
Residual royalty agreement liability, short-term portion
1,688,691
1,169,095
Total current liabilities
40,080,447
41,437,629
Residual royalty agreement liability, long-term portion
10,550,764
9,656,441
Operating lease liability, long-term portion
3,963,202
4,093,667
Other liabilities
89,181
99,644
Total liabilities
54,683,594
55,287,381
Total stockholders' equity
49,098,858
80,838,636
Total liabilities and stockholders' equity
$
103,782,452
$
136,126,017
Veru Inc.
Condensed Consolidated Statements of Operations
(unaudited)
Three Months Ended
December 31,
2022
2021
Net revenues
$
2,507,794
$
14,135,132
Cost of sales
1,805,739
2,293,050
Gross profit
702,055
11,842,082
Operating expenses:
Research and development
18,744,349
10,081,161
Selling, general and administrative
17,545,865
6,723,206
Total operating expenses
36,290,214
16,804,367
Operating loss
(35,588,159
)
(4,962,285
)
Non-operating expenses
(1,322,298
)
(1,303,066
)
Loss before income taxes
(36,910,457
)
(6,265,351
)
Income tax (benefit) expense
(68,278
)
114,655
Net loss
$
(36,842,179
)
$
(6,380,006
)
Net loss per basic and diluted common shares outstanding
$
(0.46
)
$
(0.08
)
Basic and diluted weighted average common shares outstanding
80,558,670
80,023,168
Veru Inc.
Condensed Consolidated Statements of Cash Flows
(unaudited)
Three Months Ended
December 31,
2022
2021
Net loss
$
(36,842,179
)
$
(6,380,006
)
Adjustments to reconcile net loss to net cash used in operating activities
6,407,640
2,650,481
Changes in operating assets and liabilities
(4,099,489
)
(4,928,267
)
Net cash used in operating activities
(34,534,028
)
(8,657,792
)
Net cash (used in) provided by investing activities
(285,565
)
2,197,791
Net cash provided by financing activities
1,556,105
204,427
Net decrease in cash
(33,263,488
)
(6,255,574
)
Cash at beginning of period
80,190,675
122,359,535
Cash at end of period
$
46,927,187
$
116,103,961
临床3期临床结果财报临床2期快速通道
100 项与 珠氯米芬 相关的药物交易
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研发状态
| 适应症 | 最高研发状态 | 国家/地区 | 公司 |
|---|---|---|---|
| 潮热 | 临床2期 | 美国 更多 | |
| 前列腺癌 | 临床2期 | 美国 更多 | |
| 弥漫内生性脑桥神经胶质瘤 | 临床1期 | 美国 更多 | |
| 神经母细胞瘤 | 临床1期 | 美国 更多 | |
| 淋巴瘤 | 临床1期 | 美国 更多 |
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临床结果
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适应症
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| 研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
|---|
AUA2023 AI 标引  | N/A | - | 選製糧範鏇築願鹽夢構(網糧淵顧憲製鹽廠顧膚) = 衊糧選範繭夢顧壓遞鬱 鏇鬱鬱繭窪積鏇齋製築 (繭廠顧鹹鹹壓衊壓積艱 ) 更多 | - | 2023-04-01 | ||
選製糧範鏇築願鹽夢構(網糧淵顧憲製鹽廠顧膚) = 窪憲鹽衊築範憲鏇窪構 鏇鬱鬱繭窪積鏇齋製築 (繭廠顧鹹鹹壓衊壓積艱 ) 更多 | |||||||
MP58-05 (AUA2019) AI 标引 | N/A | - | 143 | 淵餘餘鑰鏇獵獵壓鹽範(淵網鹹餘餘鏇糧淵齋築) = 積襯壓糧繭製餘範憲餘 糧獵壓遞糧選觸淵鑰鏇 (廠觸壓獵鬱壓艱夢繭壓 ) 更多 | - | 2019-04-01 | |
淵餘餘鑰鏇獵獵壓鹽範(淵網鹹餘餘鏇糧淵齋築) = 顧蓋衊構餘襯繭遞鬱積 糧獵壓遞糧選觸淵鑰鏇 (廠觸壓獵鬱壓艱夢繭壓 ) 更多 | |||||||
MP74-20 (AUA2015) AI 标引 | N/A | 307 | 製夢範醖醖築蓋構獵積(製艱繭觸簾齋艱製繭繭) = 壓獵鑰遞觸憲憲繭積繭 顧淵壓築製獵獵艱範淵 (齋鹹鬱鹹糧製餘齋鹹繭 ) | - | 2015-04-01 | ||
製夢範醖醖築蓋構獵積(製艱繭觸簾齋艱製繭繭) = 網壓積願築網艱齋遞夢 顧淵壓築製獵獵艱範淵 (齋鹹鬱鹹糧製餘齋鹹繭 ) |
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