{"success":true,"data":{"pressRelease":{"id":"172322","rtpr_id":"nBw8bGPfba-20261019","ticker":"MANE","exchange":"NYSE","all_tickers":["MANE"],"title":"Veradermics’ Oral VDPHL01 Achieved Early, Consistent, and Robust Hair Growth in Positive Phase 3 ‘304’ Clinical Trial in Male Pattern Hair Loss","author":"Business Wire","published_at":"2026-10-19T11:00:00.462Z","article_body":"Veradermics’ Oral VDPHL01 Achieved Early, Consistent, and Robust Hair Growth\nin Positive Phase 3 ‘304’ Clinical Trial in Male Pattern Hair Loss\n\nVDPHL01, a novel orally-administered extended-release minoxidil formulation,\nmet all primary and secondary endpoints with high statistical significance in\nboth active treatment arms evaluating once-daily (QD) and twice-daily (BID)\nadministration of VDPHL01\n\nVDPHL01 demonstrated increases in target area hair count (TAHC) of 28.6\nhairs/cm² (once-daily dosing; p<0.0001) and 36.4 hairs/cm² (twice-daily\ndosing; p<0.0001) versus 6.6 hairs/cm² for placebo at Month 6, a similar\nmean increase in TAHC that was observed in Study ‘302’\n\nApproximately 78.8% (QD) and 85.0% (BID) of participants reported visible\nimprovement in patient-reported outcomes (PRO) versus 35.3% of placebo\nparticipants; 55.7% (QD; p<0.0001) and 68.7% (BID; p<0.0001) of\nparticipants reported ‘improved’ or ‘much improved’ outcomes at Month\n6 versus 15.0% of placebo participants\n\nOnset of hair growth was observed with statistically significant separation\nfrom placebo in non-vellus TAHC, PRO, and Investigator Global Assessment (IGA)\nat Month 2, the earliest time point evaluated\n\nVDPHL01 demonstrated a favorable safety and tolerability profile in more than\n1,000 participants across two registration-directed studies with no new safety\nsignals emerging in Study ‘304’\n\nThese results combined with previously reported positive topline findings from\nPart A of the Phase 2/3 clinical trial (Study ‘302’) represent the full\nplacebo-controlled data set to support the potential for VDPHL01 to become the\nfirst FDA-approved non-hormonal oral treatment for the 50 million men with\npattern hair loss in the U.S.\n\nConference call and webcast scheduled for 8:00 a.m. ET today\n\nVeradermics, Incorporated (NYSE: MANE), a dermatologist-founded, late-stage\nbiopharmaceutical company focused on developing innovative therapeutics for\npattern hair loss, today announced positive topline results from Part A of its\nrandomized, double-blind, placebo-controlled registration-directed Phase 3\nclinical trial (Study ‘304’) evaluating VDPHL01, a proprietary,\nextended-release oral minoxidil formulation, in over 500 males with\nmild-to-moderate pattern hair loss. These positive registration-directed\nresults, combined with previously reported positive topline findings from Part\nA of the company’s Phase 2/3 clinical trial (Study ‘302’), position\nVDPHL01 to potentially become the first FDA-approved oral pill in nearly 30\nyears for pattern hair loss and a potential best-in-indication treatment\noption for the 50 million men with pattern hair loss in the U.S. To date,\n6-month placebo-controlled data has been reported for more than 1,000\nparticipants in registration-directed studies of VDPHL01 for the treatment of\nmale pattern hair loss.\n\nStudy ‘304’ enrolled 536 participants who were randomized to receive\neither VDPHL01 8.5mg once daily (QD), VDPHL01 8.5mg twice daily (BID), or\nplacebo. The trial met all primary and secondary endpoints with high\nstatistical significance, demonstrating a potentially differentiated clinical\nprofile defined by rapid onset of activity, consistent response across\nparticipants, and robust increases in hair count while being generally well\ntolerated with no treatment-related serious adverse events (SAEs) and no\nadverse events of special interest (AESIs) of cardiac origin.\n\nTopline Study ‘304’ Double-Blind, Placebo-Controlled Results\n\nIn Part A of Study ‘304’, VDPHL01 achieved superior hair growth compared\nwith placebo (p<0.0001) on the co‑primary endpoints of non-vellus Target\nArea Hair Count (TAHC) and patient-reported outcome (PRO) benefit of\n‘improved’ or ‘much improved’ on the Androgenetic Alopecia Impact\nRating Scale (AAIRS) at Month 6. Participants achieved an average increase in\nnon-vellus hair count of 28.6 hairs/cm² (p<0.0001) and 36.4 hairs/cm²\n(p<0.0001) in once-daily and twice-daily VDPHL01 treatment arms,\nrespectively. Those receiving placebo showed a 6.6 hairs/cm² increase from\nbaseline at Month 6.\n\nFollowing 6 months of treatment with VDPHL01, 78.8% of participants in the\nonce-daily dose arm (p<0.0001) and 85.0% of participants in the twice-daily\ndose arm (p<0.0001) reported improvement in hair coverage on the AAIRS\nversus 35.3% of placebo participants. Additionally, 55.7% of participants in\nthe once-daily dose arm (p<0.0001) and 68.7% of participants in the\ntwice-daily dose arm (p<0.0001) achieved ‘improved’ or ‘much\nimproved’ hair coverage on the AAIRS compared to 15.0% of placebo\nparticipants.\n\nThe consistency of clinically meaningful hair growth reported by participants\nwas further supported by investigator perception of hair growth, with\ninvestigators grading 78.4% (QD; p<0.0001) and 82.7% (BID; p<0.0001) of\nmale participants as having improved hair coverage at Month 6 (p<0.0001)\nusing the Investigator Global Assessment (IGA) scale. Rapid onset of hair\ngrowth was also observed at the earliest time point measured in the trial,\nwith statistically significant separation from placebo on TAHC, PRO, and IGA\nas early as Month 2.\n\nTable 1: Study ‘304’ and Study ‘302’ Topline Data Results\n                                                                                New Study ‘304’ Topline                                                       Previously Reported Study ‘302’ Topline*                                       \n                                                                                QD                             BID                            Placebo         QD                             BID                            Placebo          \n Mean increase in non-vellus hair count                                         28.6 hairs/cm² (p<0.0001)      36.4 hairs/cm² (p<0.0001)      6.6 hairs/cm²   30.3 hairs/cm² (p<0.0001)      33.0 hairs/cm² (p<0.0001)      7.3 hairs/cm²    \n Participants achieving ‘improved’ or ‘much improved’ hair coverage on          55.7% (p<0.0001)               68.7% (p<0.0001)               15.0%           48.4% (p<0.0001)               62.9% (p<0.0001)               13.4%            \n the AAIRS                                                                                                                                                                                                                                   \n *Study '302' is an ongoing randomized, double-blind, placebo-controlled Phase                                                                                                                                                               \n 2/3 clinical trial evaluating VDPHL01 in over 500 males with mild-to-moderate                                                                                                                                                               \n pattern hair loss. Positive topline results from Part A of Study '302' were                                                                                                                                                                 \n reported in April 2026.                                                                                                                                                                                                                     \n\n\nTreatment with VDPHL01 was generally well tolerated through Month 6 with an\noverall safety profile consistent with Study ‘302’. No treatment-related\nSAEs and no AESIs of cardiac origin were observed in the study.\n\nTable 2: Study ‘304’ and Study ‘302’ Topline Safety Data\n                                                                                                   New Study ‘304’ Topline             Previously Reported Study ‘302’ Topline            \n                                                                                                   QD          BID         Placebo     QD               BID              Placebo          \n TEAE >5%                                       Peripheral Edema                                   2.8%        4.5%        0.6%        5.3%             6.3%             0%               \n \n                                                                                                                                                                                        \n \nin either Study ‘304’ or Study ‘302’                                                                                                                                                    \n                                                Peripheral Edema leading to study discontinuation  0%          0.6%        0%          1.2%             1.1%             0%               \n                                                Hypertrichosis                                     2.2%        9.0%        0%          3.5%             6.3%             0.6%             \n                                                Hypertrichosis leading to study discontinuation    0%          0.6%        0%          0%               0%               0%               \n\n\n“With topline findings from our Phase 3 Study ‘304’, we have now\nreported positive topline placebo-controlled data from two\nregistration-directed trials that together enrolled more than 1,000 male\nparticipants. These results indicated that our proprietary, extended-release\nVDPHL01 formulation delivered marked increases in hair growth, while\nminimizing side effects and cardiac risk,” said Reid Waldman, M.D., Chief\nExecutive Officer of Veradermics. “Based on these results, we believe\nVDPHL01 has the potential to transform the treatment of pattern hair loss for\nmillions of people. Later this year, we also anticipate reporting the\nlonger-term data from Part B of Study ‘302’, further extending the safety\nfindings of VDPHL01 in males through 12 months.”\n\n“The Phase 3 data for VDPHL01 for males helps address two important\nquestions patients ask about a hair loss treatment: ‘Am I likely to see a\ndifference, and will I feel comfortable taking it?’ The results showed a\nhigh likelihood of visible improvement, with a safety and tolerability profile\nthat is encouraging,” said Antonella Tosti, M.D., Fredric Brandt Endowed\nProfessor of Dermatology and Cutaneous Surgery, University of Miami. “The\nconsistency of the findings across Studies '302’ and ‘304’, the large\nnumber of participants studied, and the rigor of the hair growth assessments\ngive me confidence in these results. I believe VDPHL01 has the potential to\nbecome the new standard of care for male pattern hair loss, if approved.”\n\n“We have had limited advances in prescription treatments for pattern hair\nloss, and achieving patients’ treatment goals remains a challenge. That can\nbe frustrating for patients and for those of us treating them,” stated\nMichael J. Payette, M.D., M.B.A., Central Connecticut Dermatology, Associate\nClinical Professor, UConn Health. “The VDPHL01 results are encouraging and\ngive us reason to expect more from treatment. If approved, VDPHL01 could give\nphysicians greater confidence to bring up hair loss, offer treatment, and help\nmore patients see a meaningful improvement in their pattern hair loss.”\n\nStudy ‘304’ is part of Veradermics’ registration-directed development\nprogram to support the potential approval of VDPHL01 in both male and female\npattern hair loss. In April 2026, Veradermics announced positive topline\nresults from Part A of its randomized, double-blind, placebo-controlled Phase\n2/3 clinical trial (Study ‘302’) evaluating VDPHL01 in over 500 males with\nmild-to-moderate pattern hair loss. The Company anticipates announcing data\nfrom Part B of Study ‘302’ later this year. Veradermics also announced in\nAugust completion of participant enrollment for its female pattern hair loss\nPhase 2/3 trial, Study ‘306’, with a readout of topline data anticipated\nin the first half of 2027.\n\nVeradermics will host a conference call and live webcast today at 8:00 a.m. ET\nto discuss the topline Study ‘304’ results. A live webcast will be\navailable on the Events\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fir.veradermics.com%2Fnews-events%2Fevents&esheet=54624277&newsitemid=20261019684103&lan=en-US&anchor=Events&index=1&md5=0c9a366b7addcd8124408db019c234d8)\npage in the Investors section of the Company’s website\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.veradermics.com%2F&esheet=54624277&newsitemid=20261019684103&lan=en-US&anchor=website&index=2&md5=443c546e506a2e12f9118db0160ef7a7)\n. A replay will be available following the call.\n\nAbout VDPHL01\n\nVDPHL01 (extended-release minoxidil tablet) is a proprietary investigational,\noral non-hormonal drug in Phase 3 development for pattern hair loss in both\nwomen and men. VDPHL01 leverages extended-release technology to deliver a\nminoxidil product with the potential for improved efficacy and safety. The\nproprietary extended-release formulation utilizes a gel matrix designed to\ndeliver long-lasting, steady release of minoxidil for sustained absorption.\nVDPHL01 has been shown to avoid the high peak concentrations of\nimmediate-release oral minoxidil, while extending time above the minimum hair\ngrowth threshold to increase time for hair to grow. If approved, VDPHL01 would\nbe the only FDA-approved oral non-hormonal treatment for pattern hair loss in\nboth male and female patients. VDPHL01 is protected by a broad library of\npatents and patent applications related to the key innovations of VDPHL01. The\nearliest expiring patent term is 2043.\n\nAbout the VDPHL01 Registration-Directed Clinical Development Program\n\nThe registration-directed clinical development program for VDPHL01 comprises\nthree multicenter, randomized, double-blind, placebo-controlled trials that\ntogether enrolled more than 1,600 adult men and women with mild-to-moderate\npattern hair loss.\n\nEach trial employs a 52-week design consisting of a 6-month placebo-controlled\nperiod followed by a 6-month extension in which all participants receive\nVDPHL01. Each trial has the same co-primary endpoints at Month 6: change from\nbaseline in non-vellus target area hair count (TAHC), and the proportion of\nparticipants reporting “improved” or “much improved” hair coverage on\nthe Androgenetic Alopecia Impact Rating Scale (AAIRS). Studies ‘302’ and\n‘306’ include a Phase 2 component to further assess the proprietary\npatient-reported outcome (PRO) measures used across the program.\n\nThese trials are designed to support the potential FDA approval of VDPHL01 in\nboth male and female pattern hair loss and include:\n\n\n * Study ‘302’ (NCT06724614): Phase 2/3 trial of VDPHL01 8.5 mg once and\ntwice daily in 519 men.\n\n * Study ‘304’ (NCT06972264): Phase 3 trial of VDPHL01 8.5 mg once and twice\ndaily in 536 men.\n\n * Study ‘306’ (NCT07146022): Phase 2/3 trial of VDPHL01 4.5 mg once and\ntwice daily in 556 women. It is the first registration-directed trial of an\noral therapy specifically for female pattern hair loss in the U.S.\n\nThe program builds on earlier clinical studies of VDPHL01, including Study\n‘207,’ an open-label Phase 2 proof-of-concept trial in men and women with\npattern hair loss, and a Phase 1 pharmacokinetic study.\n\nAbout Pattern Hair Loss\n\nPattern hair loss, also known as androgenetic alopecia, affects an estimated\n80 million people in the United States (30 million women and 50 million men).\nPattern hair loss can have a significant impact on quality of life, affecting\nan individual’s mental health and relationships. People with pattern hair\nloss often experience depression, low self-esteem, and social withdrawal.\nThere have been no new FDA-approved prescription medicines for pattern hair\nloss in nearly 30 years. In addition, current treatments include\nover-the-counter “nutraceuticals” that produce inconsistent results and\ncontribute to high dissatisfaction among patients and healthcare providers.\nThe prevalence of pattern hair loss and the market demand for new treatments\ncontribute to making it the largest aesthetics market worldwide, projected to\nreach approximately $30 billion by 2028.\n\nAbout Veradermics, Inc.\n\nVeradermics is a dermatologist-founded, late clinical-stage biopharmaceutical\ncompany focused on developing innovative therapeutics for pattern hair loss.\nVeradermics aims to develop a focused portfolio of aesthetic dermatology\nproduct candidates targeting high-prevalence dermatologic conditions, with\npotential selective development of medical dermatology product candidates. Its\nlead program, VDPHL01, is being developed as an oral, non-hormonal treatment\nfor men and women with pattern hair loss, to reduce the barriers to wide\nadoption of chronic hair loss therapy and potentially transform pattern hair\nloss treatment. VDPHL01 is an oral, extended-release proprietary formulation\nof minoxidil, a proven hair growth agent, designed to maximize minoxidil’s\nimpact on hair restoration while minimizing the risk of cardiac activity. For\nadditional information, visit www.veradermics.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.veradermics.com&esheet=54624277&newsitemid=20261019684103&lan=en-US&anchor=www.veradermics.com&index=3&md5=18c207f569bb64365a51dc896fc9cb3b)\nand follow us on LinkedIn\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fveradermics%2F&esheet=54624277&newsitemid=20261019684103&lan=en-US&anchor=LinkedIn&index=4&md5=bc5a928fd595ba6be9a49f78bad688cb)\nand Instagram\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.instagram.com%2Fveradermics%2F&esheet=54624277&newsitemid=20261019684103&lan=en-US&anchor=Instagram&index=5&md5=df5e487424a5659bf944e15bd38d8107)\n.\n\nForward-Looking Statements\n\nThis press release contains forward-looking statements, which involve risks,\nuncertainties and contingencies, many of which are beyond the control of\nVeradermics, which may cause actual results, performance, or achievements to\ndiffer materially from anticipated results, performance, or achievements. All\nstatements other than statements of historical facts contained in this press\nrelease are forward-looking statements. In some cases, forward-looking\nstatements can be identified by terms such as “may,” “will,”\n“should,” “expect,” “plan,” “anticipate,” “could,”\n“intend,” “target,” “project,” “contemplate,” “believe,”\n“estimate,” “predict,” “potential” or “continue” or the\nnegative of these terms or other similar expressions, although not all\nforward-looking statements contain these words. Investors are cautioned not to\nplace undue reliance on these forward-looking statements, including statements\nregarding the clinical profile of VDPHL01, including its safety profile; the\nperceived benefits of VDPHL01; VDPHL01’s potential to become the\nbest-in-indication treatment option and the new standard of care for the 50\nmillion men with pattern hair loss in the U.S.; the perceived efficacy of\nVDPHL01; the timing of reporting additional clinical results, including\nanticipated data from Studies ‘302’, ‘304’ and ‘306’; VDPHL01’s\npotential to become the first FDA-approved non-hormonal oral treatment for\npattern hair loss; the projected size of the market for pattern hair loss; and\nthe scope and duration of patent protection for VDPHL01. These forward-looking\nstatements are based upon current estimates and assumptions and are subject to\nvarious risks and uncertainties that could cause actual results to differ\nmaterially from those anticipated in the forward-looking statements,\nincluding: Veradermics’ limited operating history with no products approved\nfor commercial sale; Veradermics’ incurrence of substantial losses since its\ninception, anticipation of incurring substantial and increasing losses for the\nforeseeable future and need for substantial additional financing to achieve\nits goals; Veradermics’ anticipation that its success will depend on the\napproval and successful commercialization of VDPHL01, which is its lead\nproduct candidate, and if Veradermics is unable to obtain regulatory approval\nfor, and successfully commercialize, VDPHL01, or any other current or future\nproduct candidates, or experience significant delays in doing so, its business\nwill be materially harmed; the risk that adverse events or undesirable side\neffects are caused by Veradermics’ product candidates; competition from\nother companies; and other risks and uncertainties identified in the “Risk\nFactors” section of Veradermics’ Quarterly Report on Form 10-Q, for the\nperiod ended June 30, 2026, and subsequent filings with the U.S. Securities\nand Exchange Commission. The events and circumstances reflected in the\nforward-looking statements may not be achieved or occur and actual future\nresults, levels of activity, performance and events and circumstances could\ndiffer materially from those projected in the forward-looking statements.\nBecause forward-looking statements are inherently subject to risks and\nuncertainties, some of which cannot be predicted or quantified and some of\nwhich are beyond Veradermics’ control, these forward-looking statements\nshould not be relied upon as guarantees of future events. Moreover,\nVeradermics operates in an evolving environment. New risks and uncertainties\nmay emerge from time to time, and management cannot predict all risks and\nuncertainties. These forward-looking statements speak only as of the date of\nthis press release, and Veradermics undertakes no obligation to publicly\nupdate or revise any forward-looking statements, whether as a result of new\ninformation, future events or otherwise, except as required by applicable law.\n\n\n\nView source version on businesswire.com:\nhttps://www.businesswire.com/news/home/20261019684103/en/\n(https://www.businesswire.com/news/home/20261019684103/en/)\n\nMedia:\n\nCatherine Collier Kyroulis\n\nMedia@veradermics.com \n(mailto:Media@veradermics.com) \n(917) 886-5586\n\nInvestors:\n\ninvestors@veradermics.com (mailto:investors@veradermics.com)\n\n\nCopyright Business Wire 2026","article_body_html":"","raw_payload":{"data":{"id":"nBw8bGPfba-20261019","title":"Veradermics’ Oral VDPHL01 Achieved Early, Consistent, and Robust Hair Growth in Positive Phase 3 ‘304’ Clinical Trial in Male Pattern Hair Loss","author":"Business Wire","ticker":"MANE","created":"2026-10-19T11:00:00.462Z","tickers":["MANE"],"exchange":"NYSE","article_body":"Veradermics’ Oral VDPHL01 Achieved Early, Consistent, and Robust Hair Growth\nin Positive Phase 3 ‘304’ Clinical Trial in Male Pattern Hair Loss\n\nVDPHL01, a novel orally-administered extended-release minoxidil formulation,\nmet all primary and secondary endpoints with high statistical significance in\nboth active treatment arms evaluating once-daily (QD) and twice-daily (BID)\nadministration of VDPHL01\n\nVDPHL01 demonstrated increases in target area hair count (TAHC) of 28.6\nhairs/cm² (once-daily dosing; p<0.0001) and 36.4 hairs/cm² (twice-daily\ndosing; p<0.0001) versus 6.6 hairs/cm² for placebo at Month 6, a similar\nmean increase in TAHC that was observed in Study ‘302’\n\nApproximately 78.8% (QD) and 85.0% (BID) of participants reported visible\nimprovement in patient-reported outcomes (PRO) versus 35.3% of placebo\nparticipants; 55.7% (QD; p<0.0001) and 68.7% (BID; p<0.0001) of\nparticipants reported ‘improved’ or ‘much improved’ outcomes at Month\n6 versus 15.0% of placebo participants\n\nOnset of hair growth was observed with statistically significant separation\nfrom placebo in non-vellus TAHC, PRO, and Investigator Global Assessment (IGA)\nat Month 2, the earliest time point evaluated\n\nVDPHL01 demonstrated a favorable safety and tolerability profile in more than\n1,000 participants across two registration-directed studies with no new safety\nsignals emerging in Study ‘304’\n\nThese results combined with previously reported positive topline findings from\nPart A of the Phase 2/3 clinical trial (Study ‘302’) represent the full\nplacebo-controlled data set to support the potential for VDPHL01 to become the\nfirst FDA-approved non-hormonal oral treatment for the 50 million men with\npattern hair loss in the U.S.\n\nConference call and webcast scheduled for 8:00 a.m. ET today\n\nVeradermics, Incorporated (NYSE: MANE), a dermatologist-founded, late-stage\nbiopharmaceutical company focused on developing innovative therapeutics for\npattern hair loss, today announced positive topline results from Part A of its\nrandomized, double-blind, placebo-controlled registration-directed Phase 3\nclinical trial (Study ‘304’) evaluating VDPHL01, a proprietary,\nextended-release oral minoxidil formulation, in over 500 males with\nmild-to-moderate pattern hair loss. These positive registration-directed\nresults, combined with previously reported positive topline findings from Part\nA of the company’s Phase 2/3 clinical trial (Study ‘302’), position\nVDPHL01 to potentially become the first FDA-approved oral pill in nearly 30\nyears for pattern hair loss and a potential best-in-indication treatment\noption for the 50 million men with pattern hair loss in the U.S. To date,\n6-month placebo-controlled data has been reported for more than 1,000\nparticipants in registration-directed studies of VDPHL01 for the treatment of\nmale pattern hair loss.\n\nStudy ‘304’ enrolled 536 participants who were randomized to receive\neither VDPHL01 8.5mg once daily (QD), VDPHL01 8.5mg twice daily (BID), or\nplacebo. The trial met all primary and secondary endpoints with high\nstatistical significance, demonstrating a potentially differentiated clinical\nprofile defined by rapid onset of activity, consistent response across\nparticipants, and robust increases in hair count while being generally well\ntolerated with no treatment-related serious adverse events (SAEs) and no\nadverse events of special interest (AESIs) of cardiac origin.\n\nTopline Study ‘304’ Double-Blind, Placebo-Controlled Results\n\nIn Part A of Study ‘304’, VDPHL01 achieved superior hair growth compared\nwith placebo (p<0.0001) on the co‑primary endpoints of non-vellus Target\nArea Hair Count (TAHC) and patient-reported outcome (PRO) benefit of\n‘improved’ or ‘much improved’ on the Androgenetic Alopecia Impact\nRating Scale (AAIRS) at Month 6. Participants achieved an average increase in\nnon-vellus hair count of 28.6 hairs/cm² (p<0.0001) and 36.4 hairs/cm²\n(p<0.0001) in once-daily and twice-daily VDPHL01 treatment arms,\nrespectively. Those receiving placebo showed a 6.6 hairs/cm² increase from\nbaseline at Month 6.\n\nFollowing 6 months of treatment with VDPHL01, 78.8% of participants in the\nonce-daily dose arm (p<0.0001) and 85.0% of participants in the twice-daily\ndose arm (p<0.0001) reported improvement in hair coverage on the AAIRS\nversus 35.3% of placebo participants. Additionally, 55.7% of participants in\nthe once-daily dose arm (p<0.0001) and 68.7% of participants in the\ntwice-daily dose arm (p<0.0001) achieved ‘improved’ or ‘much\nimproved’ hair coverage on the AAIRS compared to 15.0% of placebo\nparticipants.\n\nThe consistency of clinically meaningful hair growth reported by participants\nwas further supported by investigator perception of hair growth, with\ninvestigators grading 78.4% (QD; p<0.0001) and 82.7% (BID; p<0.0001) of\nmale participants as having improved hair coverage at Month 6 (p<0.0001)\nusing the Investigator Global Assessment (IGA) scale. Rapid onset of hair\ngrowth was also observed at the earliest time point measured in the trial,\nwith statistically significant separation from placebo on TAHC, PRO, and IGA\nas early as Month 2.\n\nTable 1: Study ‘304’ and Study ‘302’ Topline Data Results\n                                                                                New Study ‘304’ Topline                                                       Previously Reported Study ‘302’ Topline*                                       \n                                                                                QD                             BID                            Placebo         QD                             BID                            Placebo          \n Mean increase in non-vellus hair count                                         28.6 hairs/cm² (p<0.0001)      36.4 hairs/cm² (p<0.0001)      6.6 hairs/cm²   30.3 hairs/cm² (p<0.0001)      33.0 hairs/cm² (p<0.0001)      7.3 hairs/cm²    \n Participants achieving ‘improved’ or ‘much improved’ hair coverage on          55.7% (p<0.0001)               68.7% (p<0.0001)               15.0%           48.4% (p<0.0001)               62.9% (p<0.0001)               13.4%            \n the AAIRS                                                                                                                                                                                                                                   \n *Study '302' is an ongoing randomized, double-blind, placebo-controlled Phase                                                                                                                                                               \n 2/3 clinical trial evaluating VDPHL01 in over 500 males with mild-to-moderate                                                                                                                                                               \n pattern hair loss. Positive topline results from Part A of Study '302' were                                                                                                                                                                 \n reported in April 2026.                                                                                                                                                                                                                     \n\n\nTreatment with VDPHL01 was generally well tolerated through Month 6 with an\noverall safety profile consistent with Study ‘302’. No treatment-related\nSAEs and no AESIs of cardiac origin were observed in the study.\n\nTable 2: Study ‘304’ and Study ‘302’ Topline Safety Data\n                                                                                                   New Study ‘304’ Topline             Previously Reported Study ‘302’ Topline            \n                                                                                                   QD          BID         Placebo     QD               BID              Placebo          \n TEAE >5%                                       Peripheral Edema                                   2.8%        4.5%        0.6%        5.3%             6.3%             0%               \n \n                                                                                                                                                                                        \n \nin either Study ‘304’ or Study ‘302’                                                                                                                                                    \n                                                Peripheral Edema leading to study discontinuation  0%          0.6%        0%          1.2%             1.1%             0%               \n                                                Hypertrichosis                                     2.2%        9.0%        0%          3.5%             6.3%             0.6%             \n                                                Hypertrichosis leading to study discontinuation    0%          0.6%        0%          0%               0%               0%               \n\n\n“With topline findings from our Phase 3 Study ‘304’, we have now\nreported positive topline placebo-controlled data from two\nregistration-directed trials that together enrolled more than 1,000 male\nparticipants. These results indicated that our proprietary, extended-release\nVDPHL01 formulation delivered marked increases in hair growth, while\nminimizing side effects and cardiac risk,” said Reid Waldman, M.D., Chief\nExecutive Officer of Veradermics. “Based on these results, we believe\nVDPHL01 has the potential to transform the treatment of pattern hair loss for\nmillions of people. Later this year, we also anticipate reporting the\nlonger-term data from Part B of Study ‘302’, further extending the safety\nfindings of VDPHL01 in males through 12 months.”\n\n“The Phase 3 data for VDPHL01 for males helps address two important\nquestions patients ask about a hair loss treatment: ‘Am I likely to see a\ndifference, and will I feel comfortable taking it?’ The results showed a\nhigh likelihood of visible improvement, with a safety and tolerability profile\nthat is encouraging,” said Antonella Tosti, M.D., Fredric Brandt Endowed\nProfessor of Dermatology and Cutaneous Surgery, University of Miami. “The\nconsistency of the findings across Studies '302’ and ‘304’, the large\nnumber of participants studied, and the rigor of the hair growth assessments\ngive me confidence in these results. I believe VDPHL01 has the potential to\nbecome the new standard of care for male pattern hair loss, if approved.”\n\n“We have had limited advances in prescription treatments for pattern hair\nloss, and achieving patients’ treatment goals remains a challenge. That can\nbe frustrating for patients and for those of us treating them,” stated\nMichael J. Payette, M.D., M.B.A., Central Connecticut Dermatology, Associate\nClinical Professor, UConn Health. “The VDPHL01 results are encouraging and\ngive us reason to expect more from treatment. If approved, VDPHL01 could give\nphysicians greater confidence to bring up hair loss, offer treatment, and help\nmore patients see a meaningful improvement in their pattern hair loss.”\n\nStudy ‘304’ is part of Veradermics’ registration-directed development\nprogram to support the potential approval of VDPHL01 in both male and female\npattern hair loss. In April 2026, Veradermics announced positive topline\nresults from Part A of its randomized, double-blind, placebo-controlled Phase\n2/3 clinical trial (Study ‘302’) evaluating VDPHL01 in over 500 males with\nmild-to-moderate pattern hair loss. The Company anticipates announcing data\nfrom Part B of Study ‘302’ later this year. Veradermics also announced in\nAugust completion of participant enrollment for its female pattern hair loss\nPhase 2/3 trial, Study ‘306’, with a readout of topline data anticipated\nin the first half of 2027.\n\nVeradermics will host a conference call and live webcast today at 8:00 a.m. ET\nto discuss the topline Study ‘304’ results. A live webcast will be\navailable on the Events\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fir.veradermics.com%2Fnews-events%2Fevents&esheet=54624277&newsitemid=20261019684103&lan=en-US&anchor=Events&index=1&md5=0c9a366b7addcd8124408db019c234d8)\npage in the Investors section of the Company’s website\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.veradermics.com%2F&esheet=54624277&newsitemid=20261019684103&lan=en-US&anchor=website&index=2&md5=443c546e506a2e12f9118db0160ef7a7)\n. A replay will be available following the call.\n\nAbout VDPHL01\n\nVDPHL01 (extended-release minoxidil tablet) is a proprietary investigational,\noral non-hormonal drug in Phase 3 development for pattern hair loss in both\nwomen and men. VDPHL01 leverages extended-release technology to deliver a\nminoxidil product with the potential for improved efficacy and safety. The\nproprietary extended-release formulation utilizes a gel matrix designed to\ndeliver long-lasting, steady release of minoxidil for sustained absorption.\nVDPHL01 has been shown to avoid the high peak concentrations of\nimmediate-release oral minoxidil, while extending time above the minimum hair\ngrowth threshold to increase time for hair to grow. If approved, VDPHL01 would\nbe the only FDA-approved oral non-hormonal treatment for pattern hair loss in\nboth male and female patients. VDPHL01 is protected by a broad library of\npatents and patent applications related to the key innovations of VDPHL01. The\nearliest expiring patent term is 2043.\n\nAbout the VDPHL01 Registration-Directed Clinical Development Program\n\nThe registration-directed clinical development program for VDPHL01 comprises\nthree multicenter, randomized, double-blind, placebo-controlled trials that\ntogether enrolled more than 1,600 adult men and women with mild-to-moderate\npattern hair loss.\n\nEach trial employs a 52-week design consisting of a 6-month placebo-controlled\nperiod followed by a 6-month extension in which all participants receive\nVDPHL01. Each trial has the same co-primary endpoints at Month 6: change from\nbaseline in non-vellus target area hair count (TAHC), and the proportion of\nparticipants reporting “improved” or “much improved” hair coverage on\nthe Androgenetic Alopecia Impact Rating Scale (AAIRS). Studies ‘302’ and\n‘306’ include a Phase 2 component to further assess the proprietary\npatient-reported outcome (PRO) measures used across the program.\n\nThese trials are designed to support the potential FDA approval of VDPHL01 in\nboth male and female pattern hair loss and include:\n\n\n * Study ‘302’ (NCT06724614): Phase 2/3 trial of VDPHL01 8.5 mg once and\ntwice daily in 519 men.\n\n * Study ‘304’ (NCT06972264): Phase 3 trial of VDPHL01 8.5 mg once and twice\ndaily in 536 men.\n\n * Study ‘306’ (NCT07146022): Phase 2/3 trial of VDPHL01 4.5 mg once and\ntwice daily in 556 women. It is the first registration-directed trial of an\noral therapy specifically for female pattern hair loss in the U.S.\n\nThe program builds on earlier clinical studies of VDPHL01, including Study\n‘207,’ an open-label Phase 2 proof-of-concept trial in men and women with\npattern hair loss, and a Phase 1 pharmacokinetic study.\n\nAbout Pattern Hair Loss\n\nPattern hair loss, also known as androgenetic alopecia, affects an estimated\n80 million people in the United States (30 million women and 50 million men).\nPattern hair loss can have a significant impact on quality of life, affecting\nan individual’s mental health and relationships. People with pattern hair\nloss often experience depression, low self-esteem, and social withdrawal.\nThere have been no new FDA-approved prescription medicines for pattern hair\nloss in nearly 30 years. In addition, current treatments include\nover-the-counter “nutraceuticals” that produce inconsistent results and\ncontribute to high dissatisfaction among patients and healthcare providers.\nThe prevalence of pattern hair loss and the market demand for new treatments\ncontribute to making it the largest aesthetics market worldwide, projected to\nreach approximately $30 billion by 2028.\n\nAbout Veradermics, Inc.\n\nVeradermics is a dermatologist-founded, late clinical-stage biopharmaceutical\ncompany focused on developing innovative therapeutics for pattern hair loss.\nVeradermics aims to develop a focused portfolio of aesthetic dermatology\nproduct candidates targeting high-prevalence dermatologic conditions, with\npotential selective development of medical dermatology product candidates. Its\nlead program, VDPHL01, is being developed as an oral, non-hormonal treatment\nfor men and women with pattern hair loss, to reduce the barriers to wide\nadoption of chronic hair loss therapy and potentially transform pattern hair\nloss treatment. VDPHL01 is an oral, extended-release proprietary formulation\nof minoxidil, a proven hair growth agent, designed to maximize minoxidil’s\nimpact on hair restoration while minimizing the risk of cardiac activity. For\nadditional information, visit www.veradermics.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.veradermics.com&esheet=54624277&newsitemid=20261019684103&lan=en-US&anchor=www.veradermics.com&index=3&md5=18c207f569bb64365a51dc896fc9cb3b)\nand follow us on LinkedIn\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fveradermics%2F&esheet=54624277&newsitemid=20261019684103&lan=en-US&anchor=LinkedIn&index=4&md5=bc5a928fd595ba6be9a49f78bad688cb)\nand Instagram\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.instagram.com%2Fveradermics%2F&esheet=54624277&newsitemid=20261019684103&lan=en-US&anchor=Instagram&index=5&md5=df5e487424a5659bf944e15bd38d8107)\n.\n\nForward-Looking Statements\n\nThis press release contains forward-looking statements, which involve risks,\nuncertainties and contingencies, many of which are beyond the control of\nVeradermics, which may cause actual results, performance, or achievements to\ndiffer materially from anticipated results, performance, or achievements. All\nstatements other than statements of historical facts contained in this press\nrelease are forward-looking statements. In some cases, forward-looking\nstatements can be identified by terms such as “may,” “will,”\n“should,” “expect,” “plan,” “anticipate,” “could,”\n“intend,” “target,” “project,” “contemplate,” “believe,”\n“estimate,” “predict,” “potential” or “continue” or the\nnegative of these terms or other similar expressions, although not all\nforward-looking statements contain these words. Investors are cautioned not to\nplace undue reliance on these forward-looking statements, including statements\nregarding the clinical profile of VDPHL01, including its safety profile; the\nperceived benefits of VDPHL01; VDPHL01’s potential to become the\nbest-in-indication treatment option and the new standard of care for the 50\nmillion men with pattern hair loss in the U.S.; the perceived efficacy of\nVDPHL01; the timing of reporting additional clinical results, including\nanticipated data from Studies ‘302’, ‘304’ and ‘306’; VDPHL01’s\npotential to become the first FDA-approved non-hormonal oral treatment for\npattern hair loss; the projected size of the market for pattern hair loss; and\nthe scope and duration of patent protection for VDPHL01. These forward-looking\nstatements are based upon current estimates and assumptions and are subject to\nvarious risks and uncertainties that could cause actual results to differ\nmaterially from those anticipated in the forward-looking statements,\nincluding: Veradermics’ limited operating history with no products approved\nfor commercial sale; Veradermics’ incurrence of substantial losses since its\ninception, anticipation of incurring substantial and increasing losses for the\nforeseeable future and need for substantial additional financing to achieve\nits goals; Veradermics’ anticipation that its success will depend on the\napproval and successful commercialization of VDPHL01, which is its lead\nproduct candidate, and if Veradermics is unable to obtain regulatory approval\nfor, and successfully commercialize, VDPHL01, or any other current or future\nproduct candidates, or experience significant delays in doing so, its business\nwill be materially harmed; the risk that adverse events or undesirable side\neffects are caused by Veradermics’ product candidates; competition from\nother companies; and other risks and uncertainties identified in the “Risk\nFactors” section of Veradermics’ Quarterly Report on Form 10-Q, for the\nperiod ended June 30, 2026, and subsequent filings with the U.S. Securities\nand Exchange Commission. The events and circumstances reflected in the\nforward-looking statements may not be achieved or occur and actual future\nresults, levels of activity, performance and events and circumstances could\ndiffer materially from those projected in the forward-looking statements.\nBecause forward-looking statements are inherently subject to risks and\nuncertainties, some of which cannot be predicted or quantified and some of\nwhich are beyond Veradermics’ control, these forward-looking statements\nshould not be relied upon as guarantees of future events. Moreover,\nVeradermics operates in an evolving environment. New risks and uncertainties\nmay emerge from time to time, and management cannot predict all risks and\nuncertainties. These forward-looking statements speak only as of the date of\nthis press release, and Veradermics undertakes no obligation to publicly\nupdate or revise any forward-looking statements, whether as a result of new\ninformation, future events or otherwise, except as required by applicable law.\n\n\n\nView source version on businesswire.com:\nhttps://www.businesswire.com/news/home/20261019684103/en/\n(https://www.businesswire.com/news/home/20261019684103/en/)\n\nMedia:\n\nCatherine Collier Kyroulis\n\nMedia@veradermics.com \n(mailto:Media@veradermics.com) \n(917) 886-5586\n\nInvestors:\n\ninvestors@veradermics.com (mailto:investors@veradermics.com)\n\n\nCopyright Business Wire 2026"},"type":"article","timestamp":"2026-10-19T11:00:01.024111931Z","server_sent_at_ms":1792407601024},"received_at":"2026-10-19T11:00:01.122Z","source_url":"https://www.businesswire.com/news/home/20261019684103/en/"},"analysis":{"id":"160462","press_release_id":"172322","analysis_json":{"industry":{"label":"Pharmaceuticals, Biotechnology & Life Sciences","sector":"Health Care"},"redFlags":["Company remains pre-revenue with no approved products and anticipates needing substantial additional financing","BID arm showed higher rates of hypertrichosis (9.0%) and peripheral edema (4.5%) than QD arm","FDA approval is not guaranteed; topline data has not yet been reviewed by regulators"],"eventType":"clinical_trial","narrative":"Veradermics' Phase 3 Study '304' met all primary and secondary endpoints for VDPHL01, an oral extended-release minoxidil for male pattern hair loss, in 536 participants with high statistical significance (p<0.0001).\n\nHair count gains reached 28.6 hairs/cm² (once daily) and 36.4 hairs/cm² (twice daily) versus 6.6 for placebo at Month 6, with onset of efficacy visible as early as Month 2 and no treatment-related serious adverse events or cardiac adverse events of special interest.\n\nCombined with positive Study '302' data, the results support a potential NDA as the first FDA-approved non-hormonal oral treatment targeting 50 million U.S. men; female-pattern Study '306' topline is expected in the first half of 2027.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"Clean Phase 3 win for first oral non-hormonal pattern hair loss drug in nearly 30 years — watch for NDA timing and cash runway questions ahead of the $30B market opportunity."},"keyFigures":{"drugName":"VDPHL01 (extended-release oral minoxidil)","phaseOfTrial":"Phase 3","customDimensions":{"tahc_qd":"28.6 hairs/cm² (p<0.0001)","tahc_bid":"36.4 hairs/cm² (p<0.0001)","pro_placebo":"15.0%","tahc_placebo":"6.6 hairs/cm²","study_304_enrollment":536,"registration_program_enrollment":"more than 1,600","pro_improved_or_much_improved_qd":"55.7%","pro_improved_or_much_improved_bid":"68.7%"}},"quotedText":"VDPHL01 has the potential to become the new standard of care for male pattern hair loss, if approved.","namedEntities":{"people":[{"name":"Reid Waldman, M.D.","role":"CEO, Veradermics"},{"name":"Antonella Tosti, M.D.","role":"Professor of Dermatology, University of Miami (key opinion leader)"},{"name":"Michael J. Payette, M.D., M.B.A.","role":"Central Connecticut Dermatology; Associate Clinical Professor, UConn Health"}],"products":["VDPHL01","Study '302'","Study '304'","Study '306'","Study '207'"],"companies":[{"name":"Veradermics, Incorporated","ticker":"MANE"}],"dollarAmounts":[{"amount":"$30 billion","context":"projected global pattern hair loss market by 2028"}]},"materialImpact":{"score":5,"reasoning":"Positive Phase 3 topline readout for the company's lead asset VDPHL01 — all primary and secondary endpoints met with p<0.0001 in both dosing arms, no cardiac safety signals. This is a binary, registration-directed event that positions the drug for potential first-of-kind FDA approval in pattern hair loss."},"tickerRelevance":{"others":[],"primary":"MANE"},"globalImportance":55,"audienceRelevance":40,"eventTypeSecondary":[],"importanceComponents":{"tickerTier":"small-cap clinical-stage biotech","uncertainty":"pre-NDA, financing needs ahead","eventGravity":"positive Phase 3 topline on lead asset","marketOpportunity":"$30B aesthetics market, consumer-facing indication","retailFavoriteBoost":"hair-loss theme resonates with retail"}},"event_type":"clinical_trial","event_type_secondary":null,"sentiment":"bullish","material_impact_score":5,"narrative":"Veradermics' Phase 3 Study '304' met all primary and secondary endpoints for VDPHL01, an oral extended-release minoxidil for male pattern hair loss, in 536 participants with high statistical significance (p<0.0001).\n\nHair count gains reached 28.6 hairs/cm² (once daily) and 36.4 hairs/cm² (twice daily) versus 6.6 for placebo at Month 6, with onset of efficacy visible as early as Month 2 and no treatment-related serious adverse events or cardiac adverse events of special interest.\n\nCombined with positive Study '302' data, the results support a potential NDA as the first FDA-approved non-hormonal oral treatment targeting 50 million U.S. men; female-pattern Study '306' topline is expected in the first half of 2027.","key_figures":{"drugName":"VDPHL01 (extended-release oral minoxidil)","phaseOfTrial":"Phase 3","customDimensions":{"tahc_qd":"28.6 hairs/cm² (p<0.0001)","tahc_bid":"36.4 hairs/cm² (p<0.0001)","pro_placebo":"15.0%","tahc_placebo":"6.6 hairs/cm²","study_304_enrollment":536,"registration_program_enrollment":"more than 1,600","pro_improved_or_much_improved_qd":"55.7%","pro_improved_or_much_improved_bid":"68.7%"}},"named_entities":{"people":[{"name":"Reid Waldman, M.D.","role":"CEO, Veradermics"},{"name":"Antonella Tosti, M.D.","role":"Professor of Dermatology, University of Miami (key opinion leader)"},{"name":"Michael J. Payette, M.D., M.B.A.","role":"Central Connecticut Dermatology; Associate Clinical Professor, UConn Health"}],"products":["VDPHL01","Study '302'","Study '304'","Study '306'","Study '207'"],"companies":[{"name":"Veradermics, Incorporated","ticker":"MANE"}],"dollarAmounts":[{"amount":"$30 billion","context":"projected global pattern hair loss market by 2028"}]},"model_name":"glm-5.3-flashx","prompt_hash":"sha256:5c812bd9e28b810d","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-10-19T11:00:12.112Z","global_importance":55,"audience_relevance":40,"importance_components":{"tickerTier":"small-cap clinical-stage biotech","uncertainty":"pre-NDA, financing needs ahead","eventGravity":"positive Phase 3 topline on lead asset","marketOpportunity":"$30B aesthetics market, consumer-facing indication","retailFavoriteBoost":"hair-loss theme resonates with retail"}},"durationMs":7077,"modelName":"glm-5.3-flashx"}}