공고 • Sep 08

Veru Advances Oral Sabizabulin into Planned Phase 2 Clinical Trial for Daraxonrasib Resistant Metastatic Pancreatic Cancer

Veru announced new preclinical data showing that sabizabulin can overcome drug resistance to daraxonrasib with potent anticancer efficacy (IC50=18.2nM) in daraxonrasib resistant human pancreatic cancer cell line which is a drug concentration that can be achieved with current sabizabulin human dosing with good safety. Based on the new, positive preclinical data, and the previous preclinical and clinical sabizabulin studies, the Company will advance sabizabulin into a planned Phase 2 clinical trial for metastatic KRAS-driven pancreatic cancer progression that has become resistant to the recent FDA approved daraxonrasib. Preclinical studies were performed using a 2D proliferation assay to evaluate the efficacy of sabizabulin in parental and daraxonrasib resistant KRAS driven pancreatic cancer cell line AsPC-1 (G12D KRAS mutation) and colon cancer HCT-116 cell line (G13D KRAS mutation). It was confirmed that the reason for daraxonrasib resistance was the reactivation of the KRAS signaling pathway in both pancreatic and colon daraxonrasib resistant cell lines. The resistance index (RI) was calculated, which is the ratio of drug concentration required to inhibit 50% cell growth (IC50) in resistant cell line compared to its parental (sensitive) cell line. The resistance index represents the fold-change in drug tolerance of the resistant cell line compared to its sensitive, parental cell line. An RI greater than 1 indicates resistance, while an RI below 1 indicates increased sensitivity to the drug. Like daraxonrasib, sabizabulin had potent anticancer activity for both pancreatic cancer and colon cancer parental cell lines regardless of the type of KRAS mutation. The daraxonrasib resistant cell lines were resistant to daraxonrasib with a RI of 68 for pancreatic cancer cell line and RI of >128 for colon cancer cell line. In contrast, daraxonrasib resistant pancreatic cancer cell lines became more sensitive (collateral sensitivity) to sabizabulin with a RI of 0.25 and daraxonrasib resistant colon cell line retained sensitivity to sabizabulin with a RI of 1. In summary, sabizabulin retained highly potent anticancer efficacy in daraxonrasib resistant pancreatic and colon cancer cell lines that had reactivation of KRAS signaling pathway as the mechanism for drug resistance to daraxonrasib. These preclinical data may also support sabizabulin as a treatment of daraxonrasib resistant cancer types beyond pancreatic cancer. Sabizabulin is a clinical stage oncology drug candidate that has a favorable safety profile with promising preliminary anticancer activity. Sabizabulin’s first-in-man study was a Phase 1/2b clinical trial evaluating safety and efficacy of sabizabulin in advanced metastatic prostate cancer (Markowski et al. Clin Cancer Res 28:2789-2795, 2022). Positive efficacy and safety clinical data from this Phase 1b/2 first-in-man clinical study of sabizabulin monotherapy conducted in 80 patients with heavily pretreated metastatic castration resistant and taxane resistant prostate cancer support the translational potential of sabizabulin treatment for daraxonrasib resistant metastatic pancreatic cancer. The Phase 1b portion utilized a 3+3 dose escalation design with escalating daily oral doses of 4.5 mg - 81 mg (7 days on drug/14 days off per 21-day cycle, which was then expanded to daily dosing). The Phase 1b portion included 39 metastatic castration resistant cancer patients that were treated with one or more novel androgen receptor targeting agents. Most patients had bone-only disease (55%) with an additional 21% having both lymph node and bone involvement with 23% of patients with prior taxane-based chemotherapy. The Phase 2 portion tested a daily dose of 63 mg in 41 heavily pretreated similar patient population, but with no prior chemotherapy. Efficacy was assessed using PCWG3 and RECIST 1.1 criteria. The maximum tolerated dose was not defined in the Phase 1b as all doses tested were well tolerated. The recommended Phase 2 dose was set at 63 mg/day. The most common adverse events (>10% frequency) at the 63 mg oral daily dosing (combined Phase 1b/2 safety data) were predominantly Grade 1-2 events. Grade =3 events included diarrhea (7.4%), fatigue (5.6%) and ALT/AST elevations (5.6% and 3.7%, respectively). Neurotoxicity and neutropenia were not observed at these dosage levels. Efficacy data in patients treated with =1 continuous cycle (21 days) of 63 mg or higher had a Kaplan-Meier median radiographic progression-free survival that was estimated to be 11.4 months with durable responses lasting greater than 12 months, occurring in 14.5% (n=55) patients. The objective response rate was 20.7% in patients with measurable disease and durable responses lasting greater than 2.75 years were observed. Compared to historical controls, the radiographic progression-free survival in similar patients was only 3.6 months and objective response rate was 2% with an alternative androgen receptor blocking agent (deBono J NEJM 382:2091, 2020). This Phase 1b/2 clinical trial had a favorable safety profile with promising preliminary antitumor activity and demonstrated that chronic oral daily dosing of sabizabulin was feasible up to 3 years. Preclinical studies including in daraxonrasib resistant pancreatic and colon cell lines and promising clinical data from Phase 1b/2 clinical trial conducted in metastatic castration resistant and taxane resistant prostate cancer support the translational potential of sabizabulin against daraxonrasib resistant metastatic pancreatic cancer. The Company plans to pursue a Phase 2b clinical study to evaluate the efficacy and safety of sabizabulin in patients who have metastatic pancreatic cancer progression while receiving treatment with daraxonrasib (RASONQUE). The Company will first seek regulatory clarity from the FDA through a preIND meeting in calendar Fourth Quarter 2026 to better understand the scope of the clinical trial. Sabizabulin is an orally bioavailable microtubule targeting agent that targets a novel binding sites on microtubules that causes crosslinking of a-tubulin with the “colchicine binding site” of ß-tubulin to inhibit microtubule polymerization (assembly). Based on over 12 peer reviewed publications in preclinical cell lines and xenograft cancer models across a broad range of tumor types, sabizabulin treatment disrupted and fragmented microtubules, inhibited cancer cell proliferation and tumor growth, prevented cancer cell invasion and metastases, and suppressed angiogenesis. Sabizabulin was able to restore chemosensitivity (pancreatic cancer) and overcome paclitaxel resistance in a variety of tumor types including taxane resistant lung, prostate, ovarian, and cervical cancers. Sabizabulin arrests the cell cycle in the G2/M halting mitosis in rapidly dividing cells resulting in cell death.

공고 • Aug 05

Veru Inc Receives Notice Of Allowance For Key Methods Of Use U S Patent For Enobosarm In Combination With Semaglutide For Quality Weight Loss

Veru Inc. had announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Patent Application titled “Compositions Comprising Selective Androgen Receptor Modulator Compounds in Combination with Weight Loss Drugs and Uses Thereof for Quality Weight Loss.” The Notice of Allowance indicates that the USPTO has determined that the patent application meets the requirements for patentability and is expected to issue as a U.S. patent. The Notice of Allowance encompasses treatment regimens where: (i) enobosarm is concurrently given with semaglutide; (ii) enobosarm is added to initial semaglutide monotherapy with said co-therapy continuing; and (iii) enobosarm continues or is initiated as monotherapy after semaglutide therapy is discontinued. The allowed claims are directed to the: (i) preservation, restoration, or gaining of lean body mass; (ii) preservation, restoration, or gaining of muscle mass; (iii) enhancement of fat mass loss, including reducing abdominal, subcutaneous, or intramuscular fat accumulation, improving body composition, lowering body fat content, and lowering fat mass; (iv) preservation, restoration, or improvement of physical function and the corresponding prevention or treatment of a number of conditions that can result from decreased physical function such as reducing or treating muscle weakness, poor balance, decreased gait speed, mobility disability, loss of independence, increased risk of falls, loss of physical function, physical disability, poor quality of life, high hospitalization rates, and/or increased mortality; (v) preservation, restoration, or gaining of bone, and the corresponding prevention or treatment of bone fractures; (vi) overcoming or improving of insulin resistance; (vii) improving of HbA1c; (viii) reduction of or treatment to prevent total body weight gain rebound after discontinuing semaglutide; (ix) reduction of or treatment to prevent fat mass gain rebound after discontinuing semaglutide; and (x) treatment to prevent or restore lean mass loss during rebound after discontinuing semaglutide. When issued, this U.S. patent will have a patent expiry of at least October 3, 2044, prior to the potential application of any patent term adjustment or patent term extension. The allowed claims add to the growing intellectual property portfolio for enobosarm for quality weight loss, including already issued enobosarm specific polymorph composition of matter patents, as well as a number of other pending uses of selective androgen receptor modulator compounds alone or in combination with weight loss drugs for quality weight loss and chronic weight management patent applications. The patent portfolio of Veru includes patent applications directed to a novel, oral, modified-release enobosarm formulation, which if such patent were to issue, would provide patent protection until at least May 2046. The Company owns a worldwide portfolio of patent applications directed to the methods of use of enobosarm in combination with weight loss drugs for higher quality weight loss and incremental weight loss. These claims encompass weight loss drugs including incretin containing drugs such as GLP-1 RA drugs. The Company continues to prosecute a number of pending patent applications worldwide covering a number of different weight loss drugs beyond semaglutide. Phase 2b PLATEAU clinical trial is a double-blind, placebo-controlled study to evaluate the effect of enobosarm 3mg on total body weight, fat mass, lean mass, physical function, bone mineral density and safety in approximately 200 older patients (age = 65 years) who have obesity (BMI = 35) and are initiating semaglutide treatment for weight reduction. The Phase 2b PLATEAU study is designed to assess the ability of enobosarm treatment to break through the weight loss plateau observed in patients with obesity receiving GLP-1 RA treatment by preserving muscle mass and physical function to achieve clinically meaningful incremental weight reduction by 68 weeks. The primary efficacy endpoint of the study is the percent change from baseline in total body weight at 68 weeks. The key secondary endpoints are total fat mass, total lean mass, physical function (stair climb test), mobility disability assessment, bone mineral density, and patient reported outcome questionnaires for physical function, HbA1c, and insulin resistance. Results of an interim analysis assessing lean body mass and fat mass as measured by DXA after subjects have completed 32 weeks is expected in the first quarter of calendar year 2027. Final topline clinical data is expected in the fourth quarter of calendar year 2027. In June 2026 Veru announced a clinical supply agreement with Novo Nordisk for its Phase 2b PLATEAU clinical study. The Phase 2b QUALITY clinical study was a positive multicenter, double-blind, placebo-controlled, randomized, dose-finding clinical trial that evaluated the safety and efficacy of enobosarm 3 mg, enobosarm 6 mg, or placebo as a treatment to augment fat loss and to prevent muscle loss in 168 older patients (=60 years of age) receiving semaglutide (Wegovy®) for weight reduction. After the efficacy dose-finding portion of the Phase 2b QUALITY clinical trial was completed at 16 weeks, participants continued into a Phase 2b maintenance extension study where all patients discontinued semaglutide treatment, but continued receiving placebo, enobosarm 3 mg, or enobosarm 6 mg as monotherapy in a double-blind fashion for 12 weeks. The Phase 2b QUALITY and Maintenance Extension clinical trial was a positive study that demonstrated that enobosarm plus semaglutide preserved lean mass and physical function and led to greater fat loss during the 16 week active weight loss period and enobosarm monotherapy prevented the regain of fat mass and total body weight lost when the GLP-1 RA was discontinued.

이자보상배율	n/a
현금	US$25.74m
자본	US$28.38m
총부채	US$8.65m
총자산	US$37.03m

데이터	최종 업데이트 (UTC 시간)
기업 분석	2026/09/09 09:34
종가	2026/09/09 00:00
수익	2026/06/30
연간 수익	2025/09/30

패키지	데이터	기간	미국 소스 예시 ^*
기업 재무제표	10년	손익계산서 현금흐름표 대차대조표	SEC 양식 10-K SEC 양식 10-Q
분석가 컨센서스 추정치	+3년	재무 예측 분석가 목표주가	분석가 리서치 보고서 Blue Matrix
시장 가격	30년	주가 배당, 분할 및 기타 조치	ICE 시장 데이터 SEC 양식 S-1
지분 구조	10년	주요 주주 내부자 거래	SEC 양식 4 SEC 양식 13D
경영진	10년	리더십 팀 이사회	SEC 양식 10-K SEC 양식 DEF 14A
주요 개발	10년	회사 공시	SEC 양식 8-K

분석가	기관
Edward Nash	Canaccord Genuity
Yuchen Ding	Jefferies LLC
Leland Gershell	Oppenheimer & Co. Inc.

Veru 대차대조표 건전성

재무 건전성 기준 점검 6/6

핵심 정보

최근 재무 건전성 업데이트

Veru Inc. Auditor Raises 'Going Concern' Doubt

Veru Receives an Additional 180 Calendar Days, or Until August 25, 2025, to Regain Compliance with the Minimum Closing Bid Price Requirement

Is Veru (NASDAQ:VERU) Using Debt In A Risky Way?

Veru Inc. Auditor Raises 'Going Concern' Doubt

Veru Receives Notification from The Nasdaq Stock Market

Is Veru (NASDAQ:VERU) A Risky Investment?

Recent updates

Veru Advances Oral Sabizabulin into Planned Phase 2 Clinical Trial for Daraxonrasib Resistant Metastatic Pancreatic Cancer

New minor risk - Shareholder dilution

Veru Inc Receives Notice Of Allowance For Key Methods Of Use U S Patent For Enobosarm In Combination With Semaglutide For Quality Weight Loss

Veru Inc. to Report Q3, 2026 Results on Aug 10, 2026

Veru Inc. Completes Enrollment for Phase 2B Plateau Clinical Trial of Enobosarm and Semaglutide Combination for High Quality Weight Loss

Veru Presents Updates on Enobosarm and Sabizabulin Drug Development and Clinical Trials At 2026 Obesity and Weight Loss Drug Development Summit

Veru Inc. has filed a Follow-on Equity Offering in the amount of $21.8 million.

New major risk - Share price stability

Veru Inc. to Report Q2, 2026 Results on May 13, 2026

Veru Enrolls First Patient in Phase 2B Plateau Clinical Trial of Enobosarm and Semaglutide Combination for High Quality Weight Loss

Veru Inc. to Report Q1, 2026 Results on Feb 11, 2026

Veru Inc., Annual General Meeting, Mar 12, 2026

Veru Inc. Auditor Raises 'Going Concern' Doubt

New major risk - Revenue and earnings growth

New major risk - Revenue and earnings growth

Veru Inc. to Report Fiscal Year 2025 Results on Dec 17, 2025

Veru Inc. has completed a Follow-on Equity Offering in the amount of $25.193 million.

Veru Inc.'s (NASDAQ:VERU) Share Price Boosted 29% But Its Business Prospects Need A Lift Too

Veru Announces Successful FDA Meeting Providing Regulatory Clarity for Enobosarm for Muscle Preservation in Combination with GLP-1 Ra for Greater Weight Loss in the Treatment of Obesity

Aging Trends And FDA Clarity Will Unlock Opportunity

Why Investors Shouldn't Be Surprised By Veru Inc.'s (NASDAQ:VERU) 40% Share Price Plunge

Veru Inc. Announces Selection of Novel Modified Release Oral Enobosarm Formulation for Chronic Weight Loss Management Following Pharmacokinetic Clinical Study

New minor risk - Share price stability

Veru Inc. to Report Q3, 2025 Results on Aug 12, 2025

Veru Inc. Reports Positive Results from Phase 2B Quality and Maintenance Extension Study Showing Enobosarm

Veru Inc.'s (NASDAQ:VERU) 28% Share Price Surge Not Quite Adding Up

Veru Inc. Reports Positive Safety Results from Phase 2b Quality Study: Enobosarm Added to Semaglutide Led to Greater Fat Loss, Preservation of Muscle, and Fewer Gastrointestinal Side Effects Compared to Semaglutide Alone

Veru: Saving Muscle Mass Amidst The GLP-1 Drug Boom

Veru Inc. to Report Q2, 2025 Results on May 08, 2025

Enobosarm Phase III And Sabizabulin Tests Will Yield Mixed Prospects

Veru Inc.'s (NASDAQ:VERU) 27% Price Boost Is Out Of Tune With Revenues

Price target decreased by 19% to US$3.25

Veru Receives an Additional 180 Calendar Days, or Until August 25, 2025, to Regain Compliance with the Minimum Closing Bid Price Requirement

Independent Director recently bought US$84k worth of stock

First quarter 2025 earnings released: US$0.012 loss per share (vs US$0.082 loss in 1Q 2024)

Veru Inc. to Report Q1, 2025 Results on Feb 13, 2025

Veru Inc., Annual General Meeting, Mar 13, 2025

Veru Announces Positive Topline Data from Phase 2b QUALITY Clinical Study

Price target increased by 16% to US$4.00

New major risk - Revenue and earnings growth

Consensus revenue estimates decrease by 75%, EPS upgraded

Consensus revenue estimates increase by 13%

High number of new directors

Is Veru (NASDAQ:VERU) Using Debt In A Risky Way?

Veru Inc. Auditor Raises 'Going Concern' Doubt

Full year 2024 earnings: EPS and revenues exceed analyst expectations

New minor risk - Market cap size

Veru Inc. Announces Meta-Analysis of Body Composition Data from Older Patients with Obesity Which Supports Potential for Enobosarm to Optimize Weight Loss At Obesityweek

Veru Receives Notification from The Nasdaq Stock Market

Consensus EPS estimates fall by 12%, revenue upgraded

Price target increased by 16% to US$4.00

Third quarter 2024 earnings: Revenues exceed analysts expectations while EPS lags behind

Is Veru (NASDAQ:VERU) A Risky Investment?

Veru Inc. to Report Q3, 2024 Results on Aug 08, 2024

What Veru Inc.'s (NASDAQ:VERU) 28% Share Price Gain Is Not Telling You

New major risk - Financial position

Veru Inc.'s (NASDAQ:VERU) 35% Dip Still Leaving Some Shareholders Feeling Restless Over Its P/SRatio

Veru Inc. to Present an Update of Veru's Phase 2B Clinical Program of Enobosarm to Augment Fat Loss and to Avoid Muscle Loss When Combined with GLP-1 Drugs for Weight Loss At the Jefferies Global Healthcare Conference

Chairman recently sold US$247k worth of stock

Consensus revenue estimates increase by 65%, EPS downgraded

High number of new and inexperienced directors

Veru Inc. to Report Q2, 2024 Results on May 08, 2024

Veru Inc. Enrolls First Patients in Phase 2b Clinical Trial of Enobosarm and Semaglutide Combination for High Quality Weight Loss

Veru Inc. Appoints Louis Aronne as Chief Medical Advisor and A Member of the Scientific Advisory Board

Veru Receives a Notification Letter from the Listing Qualifications Department of the Nasdaq Stock Market

Veru Inc. Announces New Scientific Advisory Board for Its Enobosarm Program for High Quality Weight Loss

Veru Inc. announced delayed 10-Q filing

Veru Inc. Announces U.S. Food and Drug Administration Clearance of Investigational New Drug Application for its Phase 2b Clinical Study

Veru Receives Non-Compliance Notice From Nasdaq