Mineralys Therapeutics, Inc.
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Range $30 – $56
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About the company
Mineralys Therapeutics, Inc. is a clinical-stage biopharmaceutical company, which focuses on developing medicines to target diseases driven by abnormally elevated aldosterone. Its clinical-stage product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor that are initially developing for the treatment of cardiorenal conditions affected by abnormally elevated aldosterone, including hypertension and chronic kidney disease.
- CEO
- Jon Congleton
- IPO
- 2023
- Employees
- 76
- HQ
- Radnor, PA, US
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- Market Cap
- $2.26B
- P/E
- -6.04
- Fwd P/E
- 13.48
- PEG
- 0.05
- P/S
- 0.00
- P/B
- 3.94
- EV/EBITDA
- -6.35
- Div Yield
- 0.00%
- Gross Margin
- 0.00%
- Op Margin
- 0.00%
- Net Margin
- 0.00%
- ROE
- -57.97%
- ROIC
- -57.17%
Latest fiscal year · YoY change
- Revenue
- $0+0.0%
- Gross Profit
- $0+0.0%
- Op Income
- $-170,604,000
- Net Income
- $-154,651,000+13.0%
- EPS
- $-2.29+37.4%
- OCF Growth
- +14.4%
- FCF Growth
- +14.4%
- 52W High
- $47.65
- 52W Low
- $14.29
- 50D MA
- $26.58
- 200D MA
- $30.54
- Beta
- 0.68
- RSI (14)
- 42
- Avg Volume
- 1.35M
Earnings call summaries
Pick a quarter — each call distilled into takeaways, results, and a bull vs bear read.
Mineralys said Q2 was a launch-readiness quarter for lorundrostat, backed by a large cash balance, new financing, and management confidence ahead of the December 22 PDUFA date.· August 11, 2026
- Commercial launch preparation was the main focus, with sales, payer, and field infrastructure being built ahead of the December 22 PDUFA.
- Management highlighted new clinical data showing CKD patients had blood pressure reductions comparable to the broader trial, plus a 52% placebo-adjusted UACR reduction in those with baseline albuminuria.
- The company repurchased Mitsubishi Tanabe royalty rights for $200 million upfront plus up to $100 million in milestones, while also completing a $150 million equity offering and a $500 million term loan.
- Cash, cash equivalents, and investments were $661.4 million at 6/30/2026, and management said that should fund planned operations, including launch, into 2028.
- Q&A centered on pricing, payer access, label differentiation versus baxdrostat, and whether additional CKD or other development programs could expand lorundrostat’s opportunity.
Mineralys ended Q2 2026 with cash, cash equivalents, and investments of $661.4 million as of 6/30/2026, versus $656.6 million at 12/31/2025. The company said that cash is sufficient to fund planned operations, including the commercial launch of lorundrostat, into 2028. R&D expense was $221.4 million, up from $38.3 million a year earlier, mainly due to the $200 million upfront payment to Mitsubishi Tanabe, plus smaller increases in personnel and other costs; G&A expense was $24.7 million versus $8.5 million. Total other income, net was $5 million versus $3.5 million, and net loss was $241.1 million versus $43.3 million. No next-quarter revenue or EPS guidance was given; management reiterated focus on the December 22 PDUFA date and said launch readiness and commercial staffing should be in place ahead of approval.
Jon Congleton struck an upbeat, execution-focused tone, emphasizing that the quarter was about commercial readiness, strategic capital moves, and extending lorundrostat’s clinical story. He highlighted the addition of Terry Ferguson as CMO, saying Ferguson’s cardiovascular and medical affairs background strengthens the team as the company prepares for potential commercialization. He also framed the asset as entering an important new phase, with continuing work on partnering and possible future clinical development in cardiorenal-metabolic disease.
Adam Scott Levy focused on liquidity and the cost impact of strategic actions. He said the company held $661.4 million in cash, cash equivalents, and investments at quarter-end and believes that is enough to support operations and launch into 2028. On the P&L, he pointed to R&D of $221.4 million and G&A of $24.7 million, with the R&D spike driven primarily by the $200 million upfront royalty repurchase payment to Mitsubishi Tanabe. Other income rose to $5 million, helped by interest income, while net loss was $241.1 million.
Analysts pressed on hiring for the field force, payer access, pricing, and what the early baxdrostat launch means for Mineralys. Management said it is comfortable with candidate quality and expects the sales team to be in place ahead of the PDUFA date, while payer conversations have been positive and access looks consistent with expectations. On pricing, the company said baxdrostat’s price was not a surprise, that it likely will not disclose its own price until approval or launch, and that it is still finalizing strategy while aiming to preserve value. On label strategy, management said it expects discussions with FDA in the October-November timeframe and believes launch HTN, Advanced-HTN, and explore CKD could help support differentiation, including kidney-function language and hyperkalemia data.
The bull case from the call is that lorundrostat appears to have a clinically differentiated profile and the company is preparing to launch from a position of financial strength. Management cited strong blood-pressure reductions, a 52% placebo-adjusted UACR improvement in albuminuric patients, and biomarker data that may support broader cardiorenal potential. They also said payer feedback has been positive, cash is sufficient into 2028, and launch infrastructure should be ready before the PDUFA date.
The main bear case is that the stock remains dependent on FDA approval and label details, both of which are still being negotiated. Pricing, payer access, and the eventual Medicare reimbursement path are not fully locked in, and management acknowledged coverage will likely build progressively through 2027. There is also competitive pressure from baxdrostat and uncertainty around whether additional development in CKD or other indications will materialize or require more time and capital.
AI summary of the company's earnings call · Paraphrased · Not investment advice
- Free Float
- 70.2%
- Shares Outstanding
- 88.16M
- Float Shares
- 61.91M
of shares held by institutions
229 13F filers
Buy/sell ratio 0.64. Sells can include pre-scheduled 10b5-1 plan sales, not just discretionary selling.
Top institutional holders
Largest 13F positions, with quarter-over-quarter change.
| Holder | Shares | Δ Quarter |
|---|---|---|
| Catalys Pacific, LLC | 7.90M | 0 |
| Ra Capital Management, L.P. | 7.69M | 0 |
| Blackrock, Inc. | 5.89M | ▲ 1.41M |
| Samsara Biocapital, LLC | 5.87M | 0 |
| Fmr LLC | 4.51M | ▼ 349.42K |
| State Street Corp | 4.14M | ▲ 1.21M |
| Deerfield Management Company, L.P. (Series C) | 3.96M | ▲ 3.96M |
| Vanguard Group Inc | 3.35M | ▲ 333.88K |
| Vanguard Capital Management LLC | 2.76M | ▲ 302.41K |
| Laurion Capital Management LP | 2.51M | ▲ 274.11K |
| Price T Rowe Associates Inc | 2.26M | ▲ 919.16K |
| Orbimed Advisors LLC | 2.11M | ▲ 57.40K |
Held by 203 ETFs
Biggest fund positions in MLYS by dollar value.
Recent insider transactions
Who's buying, who's selling, and how much.
| Date | Insider | Type | Shares |
|---|---|---|---|
| Aug 10, 26 | Ferguson James J. III | other | 135,000 |
| Aug 10, 26 | Ferguson James J. III | other | 102,400 |
| Aug 10, 26 | Ferguson James J. III | other | 0 |
| Aug 10, 26 | Rodman David Malcom | other | 2,170 |
| Aug 10, 26 | Rodman David Malcom | sell | 2,170 |
| Aug 10, 26 | Rodman David Malcom | other | 2,170 |
| Jul 21, 26 | Warren Eric | other | 7,438 |
| Jul 21, 26 | Warren Eric | other | 7,438 |
| Jul 21, 26 | Warren Eric | sell | 7,438 |
| Jul 17, 26 | Rodman David Malcom | other | 416 |
A “Sell” may be a pre-scheduled 10b5-1 plan sale rather than a discretionary decision — read insider selling with that in mind.
Our MLYS coverage
Recent articles, reports, and earnings notes.
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Generate MLYS report →Mineralys Therapeutics Reports Inducement Award Under Nasdaq Listing Rule 5635(c)(4)
globenewswire.com · Aug 13
Mineralys Therapeutics, Inc. (MLYS) Q2 2026 Earnings Call Transcript
seekingalpha.com · Aug 12
Mineralys Therapeutics Q2 Earnings Call Highlights
marketbeat.com · Aug 11
Mineralys Therapeutics Reports Second Quarter 2026 Financial Results and Provides Corporate Update
globenewswire.com · Aug 11
Mineralys Therapeutics Reports Inducement Awards Under Nasdaq Listing Rule 5635(c)(4)
globenewswire.com · Jul 27
What a $350,000 Insider Sale Might Mean for Mineralys Ahead of December FDA Decision
fool.com · Jun 23
Mineralys Therapeutics Presents Late-Breaking Data on Lorundrostat and Heart Failure Risk Biomarkers at The Endocrine Society Annual Meeting (ENDO 2026)
globenewswire.com · Jun 14
Mineralys Therapeutics, Inc. (MLYS) Presents at Goldman Sachs 47th Annual Global Healthcare Conference 2026 Transcript
seekingalpha.com · Jun 11
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