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September 8th

Greetings, Friend!


A conference invitation is usually filler. This one is a marker.


Veru Inc. (Nasdaq: VERU) said last week that Chairman, President and Chief Executive Officer Mitchell Steiner, M.D., will hold a fireside chat at the 2026 Cantor Global Healt-hcare Conference on September 9th, his first scheduled appearance since a summer in which the company closed a study, cleared a patent and lined up supply with the largest name in wei-ght management.


Start with the patent, because it reframes everything else.


In early August the U.S. Patent and Trademark Office issued a notice of allowance on method of use claims covering enobosarm given with wei-ght lo-ss medicines, running to at least October 3rd, 2044.


The claims are not narrow. They cover concurrent dosing with semaglutide, addition to an existing regimen, and continuation after semaglutide is stopped.


A pending application on an oral modified release formulation could carry protection into 2046.

Stated protection runway for the enobosarm combination estate. Source: Veru Inc. news release of August 4th, 2026.


Underneath the filing sits evidence already generated.


The completed Phase 2b QUALITY study enrolled 168 patients aged 60 and older receiving semaglutide.


Enobosarm at 3 mg produced a 100% relative reduction in lean mass loss versus placebo at a p value below 0.001, and the 6 mg arm showed 42% greater relative fat mass loss at 16 weeks.


On the measure that translates to daily life, the 3 mg arm cut the share of subjects losing at least 10% of stair climb power by 59.8%.

Measured results versus placebo in the Phase 2b QUALITY study. Source: Veru Inc. cardiometabolic program disclosures.


The confirmatory work is underway and fully staffed.


PLATEAU closed enrollment at 239 patients, ahead of its roughly 200 patient target.


It is double blind and placebo controlled, running 68 weeks in patients aged 65 and older with a body mass index of 35 or greater who are starting semaglutide. Interim data at 32 weeks is guided to early 2027, topline to the fourth quarter.


The company also strengthened its footing over the same period.


Cash and restricted cash reached $23.9Mn at June 30th against $15.8Mn at the close of fiscal 2025, with total stockholders' equity of $28.4Mn, and Chief Financial Officer Michele Greco said on the call that the balance is expected to fund operations beyond the interim analysis.

About Veru Inc. (Nasdaq: VERU)


Veru Inc. is a late clinical stage biopharmaceutical company based in Miami, FL, focused on cardiometabolic and inflammatory disease.


Enobosarm, the lead asset, is an oral selective androgen receptor modulator evaluated in six clinical trials across more than 1,100 patients, with consistent gains in lean mass and improved physical function.


The second molecule, sabizabulin, targets chronic inflammation related to atherosclerotic cardiovascular disease and depends on additional funding.


Value accrues through clinical milestones, patent claims and partnering. The Company reached this structure through divestiture rather than acquisition.


Veru sold its FC2 consumer health business for $18Mn at the end of December 2024, netting roughly $12.5Mn, retiring a $9.9Mn royalty liability and reducing headcount from about 210 to 22. CEO Mitchell Steiner called it the step that let Veru operate as a pure biopharmaceutical company.

Sector Analysis: Where This Theme Sits


The category is large and still growing, but second order questions are where the next differentiation comes from.


Morgan Stanley Research put its 2035 base case at $190Bn against $79Bn in 2025, with United States adoption rising toward roughly 30% of the obese and diabetic population.


Goldman Sachs Research projected the category could approach $120Bn by 2035.



Veru cites obesity prevalence of 41.5% among the 47.4Mn people in Medicare Part D plans, and notes current therapies reach less than 2% of eligible patients.

The Third Quarter Call


Management's framing on the August call was structural rather than promotional.


Chief Executive Officer Mitchell Steiner returned repeatedly to one figure, that 62.6% of patients still had clinical obesity when they reached the one year plateau, and argued older patients are most exposed to falling below a critical muscle threshold.


He flagged that Medicare coverage of G-L-P-1 therapies began on July 1st, 2026, and confirmed that Novo Nordisk supplies Wegovy for the study at no charge in return for a right of first negotiation on combination rights.

There Are 7 Key Potential Catalysts Putting (Nasdaq: VERU) On Our Radar


#1. Allowed Claims Extend Almost Two Decades Past Today. The method of use claims run to at least October 3rd, 2044, turning the VERU asset from a study result into a defensible commercial position.


#2. A Fully Enrolled Study With A Scheduled Interim Look. PLATEAU finished enrollment at 239 patients and the 32 week interim analysis for VERU is guided to early 2027.


#3. A Float Under 16Mn Shares May Create Potential For Heightened Volatility. With approx. 15.48Mn shares in its float, VERU screens as a low float idea, meaning the potential for heightened volatility may be significant.


#4. Technical Indicators Are Flashing Bullish Signals Across Terms. Barchart.com's Opinion page reported 12 of 13 technical indicators it tracks to be triggered at close on Friday. This includes the website’s composite “Trend Seeker” indicator.


#5. Reimbursement Policy Moved Toward The Target Cohort. Medicare coverage of G-L-P-1 therapies began on July 1st, 2026, addressing the payer question that has long sat over the exact population VERU is studying.


#6. VERU Has 2 Analyst Targets Pointing To Significant Upside Potential. An analyst target ($25) from Canaccord Genuity and a target ($24) from Oppenheimer hint at VERU potentially being undervalued from current chart levels.


#7. Novo Nordisk Holds A Right Of First Negotiation. The Danish firm supplies Wegovy at no cost and holds first negotiation rights on combination use, so any partnering discussion involving VERU has a known starting point.

In Summary


What makes this name worth understanding is not one number, it is the shape of the setup.


A category growing toward triple-digit scale carries a well documented side effect, and one small company has spent years building evidence and patent claims around solving it.


The 16 week evidence is on the record. The 68 week test is fully enrolled with a dated readout. Protection runs deep into the 2040s.


Against that sit the constraints of a pre commercial company with one lead asset.


For anyone building a watchlist around the muscle preservation theme, start here.


Now official: coverage is officially initiated on Veru Inc. (Nasdaq: VERU).


Stay on the lookout for updates heading your way shortly.


All the best,

Dane James

Editor Market Pulse Today


(Remember: St-ock Prices Could Be Significantly Lower Now From The Original Dates I Provided.)

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Triggered Technicals Flash Bullish Signals As (Nasdaq: VERU) Climbs Our Watchlist



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September 8th

Dear Reader,


Enrollment closed early. That is the sentence worth sitting with.


In late July, Veru Inc. (Nasdaq: VERU) said it had finished enrolling its Phase 2b PLATEAU study with 239 patients, past the roughly 200 it needed.


Small clinical companies miss enrollment targets constantly. This one cleared its target about five months after announcing the first patient enrolled.


Here is what that clock counts toward.


PLATEAU is double blind and placebo controlled, running 68 weeks in patients age 65 and older with a body mass index of 35 or greater who are starting semaglutide.


It measures oral enobosarm at 3 mg against placebo. A 32 week interim look at lean and fat mass lands in the first quarter of 2027, topline in the fourth.


Both dates were repeated without hedging in the fiscal 2026 third quarter report.

PLATEAU study parameters and scheduled readouts. Sources: full enrollment release and the third quarter report.


The question the study asks is narrow and, until recently, ignored.


G-L-P-1 therapies work. They also take muscle along with the fat.


In Veru's completed Phase 2b QUALITY study of 168 patients aged 60 and older, 34% of the wei-ght lost in the placebo arm was lean mass.


Add 3 mg of enobosarm and that figure went to zero, with estimated fat loss at 100% and a p value below 0.001.


The 6 mg arm delivered 42% greater relative fat mass loss than placebo at 16 weeks.


Then came August. The U.S. Patent and Trademark Office issued a notice of allowance covering methods of using enobosarm with wei-ght lo-ss medicines, with claims running to at least October 3rd, 2044. They cover concurrent dosing with semaglutide, adding enobosarm to an existing regimen, and using it after semaglutide is stopped.


That last one matters, because it is the window where patients regain what they lost.


One more piece landed earlier in the summer. Steiner told the third quarter call that Novo Nordisk will supply Wegovy for PLATEAU at no charge and that Veru granted Novo Nordisk a right of first negotiation on combination rights involving its G-L-P-1 products.


Read it for what it is. Novo is not writing checks. Novo is holding a door open, and it costs Veru nothing to have the largest name in the category standing in the frame.

Milestones cleared and milestones scheduled. Sources: Veru Inc. news releases and the fiscal 2026 third quarter report.


Company Breakdown: Veru Inc. (Nasdaq: VERU)


Veru is a late clinical stage biopharmaceutical company out of Miami, FL, working on cardiometabolic and inflammatory disease.


Two assets. Enobosarm, an oral selective androgen receptor modulator, has been through six clinical trials covering more than 1,100 patients. Sabizabulin, a microtubule disruptor for chronic inflammation tied to atherosclerotic cardiovascular disease, is shelved until the company funds it. Management said so plainly, which is more candor than the sector usually offers.


The operating structure was rebuilt on purpose.


Veru sold its FC2 consumer hea-lth business for $18Mn at the end of 2024, netting roughly $12.5Mn, wiping out a $9.9Mn royalty liability and taking headcount from about 210 people to 22.


No sales force. No manufacturing footprint. The company is pre-commercial, and everything it owns is a clinical program and a patent estate.


Cash and restricted cash stood at $23.9Mn at June 30th against $15.8Mn a year earlier, and Chief Financial Officer Michele Greco said that balance is expected to carry operations past the interim readout.

What Was Said On The August Call


Chief Executive Officer Mitchell Steiner, M.D., did not lead with science on the August call.


He led with a statistic about failure, noting that 62.6% of patients still had clinical obesity when they hit the one year plateau.


His argument: the plateau is not a ceiling on the medicine, it is a ceiling on body composition.


Asked by Oppenheimer's Leland Gershell whether the patent estate holds up as oral formulations arrive, Steiner pointed to pending applications reaching beyond the G-L-P-1 class.

7 Potential Catalysts Send (Nasdaq: VERU) To The Top Of Our Watchlist


#1. Enrollment Finished Ahead Of Schedule, Not Behind It. The study closed at 239 patients against a target near 200, removing for VERU one of the most common sources of slippage in a small trial.


#2. A Hard Date In The First Quarter Of 2027. The 32 week interim analysis has been repeated by management without hedging, giving VERU a scheduled event roughly two quarters out.


#3. A Low Float May Create A Strong Potential For Heightened Volatility. With approx. 15.48Mn shares in its float, VERU screens as a low float idea, meaning the potential for heightened volatility may be significant.


#4. At Least 2 Analyst Targets Point To Potential Triple-Digit Upside. An analyst target ($25) from Canaccord Genuity and a target ($24) from Oppenheimer hint at VERU potentially being undervalued from current chart levels.


#5. Multiple Barchart Technical Indicators Are Flashing. Barchart.com's Opinion page reported 12 of 13 technical indicators it tracks to be triggered at close on Friday. This includes the website’s composite “Trend Seeker” indicator.


#6. Protection That Outlasts Most Of The Current Field. Allowed claims run to at least October 3rd, 2044, with a pending formulation application reaching 2046, giving VERU a runway measured in decades rather than years.


#7. A Category Giant Holds First Right Of Negotiation. Novo Nordisk's supply agreement and right of first negotiation mean any combination deal involving VERU starts with a known counterparty.

Closing


Strip away the narrative and Veru Inc. (Nasdaq: VERU) is one question with a date attached.


Does preserving muscle change what a patient looks like after 68 weeks on a G-L-P-1 regimen?


The company has a completed study saying yes at 16 weeks, a fully enrolled study to test it at 68, a patent estate that lasts long enough to matter, and the category leader holding a right of first look.


It is also pre commercial with one asset doing nearly all the work. Both halves are the picture.


The Company’s CEO will be on the schedule at the Cantor Global Heal-thcare Conference on September 9th. Anyone tracking this name should be listening.


Coverage is now officially underway on Veru Inc. (Nasdaq: VERU).


Stay tuned for updates coming out shortly. Talk soon.


Sincerely,

FierceAnalyst | Jaks Swift

Editorial Writer



(Always Remember The St-ock Prices Could Be Significantly Lower Now From The Dates I Provided.)


*FierceInvestor (FierceInvestor . com) is owned by SWN Media LLC, a limited liability company. Data is provided from third-party sources and FierceInvestor ("FI") is not responsible for its accuracy. Make sure to always do your own research and due diligence on any day and swing profile I bring to your attention. We do not provide personalized fin-ancial advice, are not finan-cial advisors, and our opinions are not suitable for all in-vest-ors.


Pursuant to an agreement between SWN Media LLC and TD Media LLC, SWN Media LLC has been hired for a period beginning on 09/07/2026 and ending on 09/08/2026 to publicly disseminate information about (VERU:US) via digital communications. Under this agreement, TD Media LLC has paid SWN Media LLC seventeen thousand five hundred USD ("Funds"). To date, including under the previously described agreement, SWN Media LLC has been paid thirty five thousand USD ("Funds"). These Funds were part of the fifty thousand USD funds that TD Media LLC received from a third party named Goldwyn Media LLC who did receive the Funds directly or indirectly from the Issuer and does not own st-ock in the Issuer but the reader should assume that the clients of the third party own shares in the Issuer, which they will liquidate at or near the time you receive this communication and has the potential to hurt share prices.


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