Annovis Provides Corporate Updates and Reports Third Quarter 2025 Financial Results
Annovis Bio (NYSE: ANVS) provided corporate updates and third quarter 2025 financial results on November 12, 2025. Key clinical progress includes full activation of 84 Phase 3 AD sites, first patients completing 6-month treatment, and October biomarker data showing reductions in neuroinflammation and neurodegeneration versus placebo. The company published PK data for a new crystalline buntanetap form and transferred patents securing IP through 2046. Financially, cash totaled $15.3M as of September 30, 2025 (includes $6.0M and $3.4M offerings) funding operations to Q3 2026. Q3 R&D was $6.3M; G&A $1.1M; diluted net loss was $0.37 per share; shares outstanding were 20.2M.
Annovis Bio (NYSE: ANVS) ha fornito aggiornamenti aziendali e risultati finanziari del terzo trimestre 2025 il 12 novembre 2025. I principali progressi clinici includono l'attivazione completa di 84 siti di Fase 3 AD, i primi pazienti che hanno completato il trattamento di 6 mesi, e i dati biomarcatori di ottobre che mostrano riduzioni dell'infiammazione neurale e della neurodegenerazione rispetto al placebo. L'azienda ha pubblicato dati PK per una nuova forma cristallina di buntanetap e ha trasferito i brevetti che assicurano la proprietà intellettuale fino al 2046. Financialmente, la cassa ammontava a $15.3M al 30 settembre 2025 (include offerte di $6.0M e $3.4M) per finanziare le operazioni fino al Q3 2026. La spesa trimestrale R&D era $6.3M; G&A $1.1M; la perdita netta diluita è stata di $0.37 per azione; le azioni in circolazione erano 20.2M.
Annovis Bio (NYSE: ANVS) presentó actualizaciones corporativas y resultados financieros del tercer trimestre de 2025 el 12 de noviembre de 2025. Los avances clínicos clave incluyen la activación completa de 84 sitios de Fase 3 AD, los primeros pacientes que completaron el tratamiento de 6 meses, y datos biomarcadores de octubre que muestran reducciones de la neuroinflamación y la neurodegeneración frente al placebo. La compañía publicó datos PK de una nueva forma cristalina de buntanetap y transfirió patentes que aseguran la propiedad intelectual hasta el 2046. En cuanto a lo financiero, el efectivo totalizó $15.3M al 30 de septiembre de 2025 (incluyendo $6.0M y $3.4M de ofertas) para financiar operaciones hasta el Q3 2026. El gasto de I+D del Q3 fue $6.3M; G&A $1.1M; la pérdida neta diluida fue de $0.37 por acción; las acciones en circulación fueron 20.2M.
Annovis Bio (NYSE: ANVS)가 2025년 11월 12일 3분기 2025년 기업 업데이트 및 재무 실적을 발표했습니다. 주요 임상 진전으로는 84개의 3상 AD 사이트의 전면 가동, 처음으로 6개월 치료를 완료한 환자들, 그리고 10월의 바이오마커 데이터가 위약 대비 신경염증 및 신경퇴행의 감소를 보였다는 점이 포함됩니다. 회사는 새로운 결정형 buntanetap 형태에 대한 PK 데이터를 공개하고 IP를 2046까지 보유하는 특허를 이전했습니다. 재무적으로 현금은 2025년 9월 30일 기준 $15.3M으로, $6.0M 및 $3.4M의 오퍼링을 포함하여 Q3 2026까지 운영자금을 조달했습니다. Q3 R&D은 $6.3M; G&A $1.1M; 희석된 순손실은 주당 $0.37; 발행주식수는 20.2M주였습니다.
Annovis Bio (NYSE: ANVS) a fourni des mises à jour sur l'entreprise et les résultats financiers du troisième trimestre 2025 le 12 novembre 2025. Les principaux progrès cliniques comprennent l'activation complète de 84 sites de Phase 3 AD, les premiers patients ayant terminé le traitement de 6 mois, et les données biomarqueurs d'octobre montrant des réductions de l'inflammation neuro- et de la neurodégénérescence par rapport au placebo. La société a publié des données PK pour une nouvelle forme cristalline de buntanetap et a transféré des brevets protégeant la PI jusqu'à 2046. Sur le plan financier, la trésorerie s'élevait à $15.3M au 30 septembre 2025 (incluant $6.0M et $3.4M d'offres) finançant les opérations jusqu'au Q3 2026. Le R&D du T3 était $6.3M; les SG&A $1.1M; la perte nette diluée était de $0.37 par action; les actions en circulation étaient 20.2M.
Annovis Bio (NYSE: ANVS) hat am 12. November 2025 Updates zum Unternehmen und die Finanzergebnisse des dritten Quartals 2025 veröffentlicht. Wichtige klinische Fortschritte umfassen die vollständige Aktivierung von 84 Phase-3-AD-Stellen, die ersten Patienten, die eine 6-monatige Behandlung abgeschlossen haben, und biomarker Daten aus Oktober, die gegenüber Placebo Reduktionen der Neuroinflammation und Neurodegeneration zeigen. Das Unternehmen veröffentlichte PK-Daten für eine neue kristalline Form von buntanetap und übertrug Patente, die IP bis 2046 sicherstellen. Finanziell belief sich der Cash-Bestand zum 30. September 2025 auf $15.3M (einschließlich $6.0M und $3.4M Angebote), um die Operationen bis Q3 2026 zu finanzieren. Q3 F&E betrugen $6.3M; Vertrieb, Allgemeines und Verwaltung (G&A) $1.1M; die verwässerte Nettolage betrug $0.37 pro Aktie; die ausstehenden Aktien betrugen 20.2M.
Annovis Bio (NYSE: ANVS) قدمت تحديثات الشركة ونتائجها المالية للربع الثالث من عام 2025 في 12 نوفمبر 2025. التقدمات السريرية الرئيسية تشمل تفعيل كامل لـ 84 موقعاً من المرحلة 3 لعلاج اضطرابات العصب، والمرضى الأوائل الذين أكملوا العلاج لمدة 6 أشهر، وبيانات العلامات الحيوية في أكتوبر التي أظهرت انخفاضاً في الالتهاب العصبي والتدهور العصبي مقارنةً بالدواء الوهمي. قامت الشركة بنشر بيانات PK لشكل بلوري جديد من buntanetap ونقلت براءات تحمي الملكية الفكرية حتى 2046. مالياً، بلغ النقد الإجمالي $15.3M حتى 30 سبتمبر 2025 (يشمل عرضين بقيمة $6.0M و $3.4M) لتمويل العمليات حتى Q3 2026. كان إنفاق البحث والتطوير في الربع الثالث $6.3M؛ المصاريف العامة والإدارية $1.1M؛ الخسارة الصافية المطفأة للسهم كانت $0.37 للسهم؛ الأسهم القائمة كانت 20.2M.
- Cash balance of $15.3M as of Sep 30, 2025
- Offerings totaling $9.4M extend operations to Q3 2026
- All 84 pivotal Phase 3 AD sites fully activated
- Published PK data and patents secured through 2046
- R&D investment increased to $6.3M in Q3 2025
- Net loss of $0.37 per share for Q3 2025
- Cash runway limited to Q3 2026 absent additional financing
Insights
Progress across Phase 3 activation, supportive biomarker signals, stronger IP, and near‑term funding extend runway to mid‑2026.
Annovis has fully activated its pivotal Phase 3 Alzheimer’s study across all 84 U.S. sites and reports first patients completed the 6‑month treatment window, which supports an approaching symptomatic readout. The company also reported peer‑reviewed PK data for the new crystalline form of buntanetap and a patent transfer that secures intellectual property through
Dependencies and risks center on the upcoming efficacy and safety readouts and the interpretation of the October biomarker data; the release notes reductions in neuroinflammation and neurodegeneration versus placebo but gives no numerical magnitudes in this release. Financially, cash and equivalents stood at
Watch the symptomatic and biomarker readouts from the Phase 3 timeline and any disclosed numerical biomarker magnitudes or primary endpoint data; near‑term milestones include additional enrollment progress, six‑month symptomatic results, and subsequent data that would precede an NDA submission. Expect the investment runway and the clinical efficacy readouts to be the decisive factors over the next
MALVERN, Pa., Nov. 12, 2025 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (NYSE: ANVS) ("Annovis" or the "Company"), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD), today provided corporate updates and third quarter 2025 financial results.
"The past quarter delivered breakthrough progress on every front," said Maria Maccecchini, Ph.D., President and CEO of Annovis. "Our pivotal Phase 3 Alzheimer's study has achieved full activation across all clinical sites, with enrollment momentum advancing every day. We have fortified our intellectual property position by transferring all patents to our new crystal form of buntanetap while publishing compelling pharmacokinetic data that validates this milestone. The addition of a seasoned CFO strengthens our executive team precisely when it matters most. Adding to all this, we are particularly encouraged by the new biomarker findings from our Phase 2/3 study showing meaningful reductions in inflammation and neurodegeneration—powerful evidence of buntanetap's disease-modifying potential. Every element is now aligned as we move toward our data readouts—the final step before an NDA submission."
Clinical highlights – pivotal Phase 3 AD study
- Annovis’ pivotal Phase 3 study in early AD (NCT06709014) remains on track, with all 84 clinical sites fully activated, recruiting, and treating participants across the U.S.
- The trial has generated robust participation, reflecting growing enthusiasm from the patient community. The screen failure rate remains within expected projections.
- The first patients have successfully completed the 6-month treatment period, a key milestone for the upcoming symptomatic readout, reinforcing steady progress toward trial completion.
Business highlights
- In October, Annovis announced encouraging biomarker results from its Phase 2/3 AD trial, showing profound reductions in key markers of neuroinflammation and neurodegeneration after treatment with buntanetap compared to placebo. The effect was observed in patients with mild and moderate stages of the disease. These findings further validate the drug’s ability to halt the toxic cascade and reinforce its potential as a potential disease-modifying therapy.
- In September, Annovis published a new peer-reviewed article highlighting the pharmacokinetics (PK) of the novel crystalline form of buntanetap and its comparison to the original form. The study, which included data from mice, dogs, and humans, demonstrated a better solid-state stability of the new form while preserving its PK profile and metabolism. The article was published following the Company's announcement that all patents have been successfully transferred to the new crystal form, securing comprehensive global intellectual property protection through 2046.
- That same month, Annovis strengthened its leadership team with the appointment of Mark Guerin as CFO, a seasoned executive with a proven track record in driving financial strategy and operational excellence across biopharma organizations.
- In August, Annovis’ management attended the AAIC 2025 conference in Toronto, where it presented four scientific posters, covering the progress of its Phase 3 Alzheimer’s trial and PK characterization of buntanetap.
Financial results
- Annovis’ cash and cash equivalents totaled
$15.3 million as of September 30, 2025, compared to$10.6 million as of December 31, 2024. This includes gross proceeds from its recent$6.0 million and$3.4 million registered direct offerings in October, enabling the Company to fund its operations to the third quarter of 2026. Annovis had 20.2 million shares of common stock outstanding as of September 30, 2025. - Research and development expenses for the three months ending September 30, 2025, were
$6.3 million compared to$2.7 million for the three months ending September 30, 2024. - General and administrative expenses for the three months ending September 30, 2025, were
$1.1 million compared to$1.7 million for the three months ending September 30, 2024. - Annovis reported a
$0.37 b asic and diluted net loss per common share for the three months ending September 30, 2025, compared to a$0.97 b asic and diluted net loss per common share for the three months ending September 30, 2024.
About Annovis
Headquartered in Malvern, Pennsylvania, Annovis is dedicated to addressing neurodegeneration in diseases such as AD and PD. The Company is committed to developing innovative therapies that improve patient outcomes and quality of life. For more information, visit www.annovisbio.com and follow us on LinkedIn, YouTube, and X.
Investor Alerts
Interested investors and shareholders are encouraged to sign up for press releases and industry updates by registering for email alerts at https://www.annovisbio.com/email-alerts.
Forward-Looking Statements
This press release contains forward-looking statements under the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended. Actual results may differ due to various risks and uncertainties, including those outlined in the Company’s SEC filings under “Risk Factors” in its Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. The Company undertakes no obligation to update forward-looking statements except as required by law.
Contact Information:
Annovis Bio Inc.
101 Lindenwood Drive
Suite 225
Malvern, PA 19355
www.annovisbio.com
Investor Contact:
Alexander Morin, Ph.D.
Director, Strategic Communications
Annovis Bio
ir@annovisbio.com
(Tables to follow)
| Annovis Bio, Inc. | ||||||||
| Balance Sheets | ||||||||
| September 30, | ||||||||
| 2025 | December 31, | |||||||
| (Unaudited) | 2024 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 15,286,399 | $ | 10,551,916 | ||||
| Prepaid expenses and other current assets | 1,902,562 | 3,373,717 | ||||||
| Total assets | $ | 17,188,961 | $ | 13,925,633 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,112,026 | $ | 2,305,974 | ||||
| Accrued expenses | 1,621,771 | 1,575,013 | ||||||
| Total current liabilities | 3,733,797 | 3,880,987 | ||||||
| Non-current liabilities: | ||||||||
| Warrant liability | 299,000 | 737,000 | ||||||
| Total liabilities | 4,032,797 | 4,617,987 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity: | ||||||||
| Preferred stock - | — | — | ||||||
| Common stock | 2,019 | 1,414 | ||||||
| Additional paid-in capital | 167,023,392 | 144,155,694 | ||||||
| Accumulated deficit | (153,869,247 | ) | (134,849,462 | ) | ||||
| Total stockholders’ equity | 13,156,164 | 9,307,646 | ||||||
| Total liabilities and stockholders’ equity | $ | 17,188,961 | $ | 13,925,633 | ||||
| Annovis Bio, Inc. | ||||||||||||||||
| Statement of Operations | ||||||||||||||||
| (Unaudited) | ||||||||||||||||
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 6,291,171 | $ | 2,689,561 | $ | 16,464,609 | $ | 14,996,868 | ||||||||
| General and administrative | 1,143,804 | 1,698,050 | 3,524,500 | 4,963,188 | ||||||||||||
| Total operating expenses | 7,434,975 | 4,387,611 | 19,989,109 | 19,960,056 | ||||||||||||
| Operating loss | (7,434,975 | ) | (4,387,611 | ) | (19,989,109 | ) | (19,960,056 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 152,317 | 135,430 | 531,324 | 205,576 | ||||||||||||
| Other financing costs | — | (524,068 | ) | — | (1,870,128 | ) | ||||||||||
| Change in fair value of warrants | 20,000 | (7,862,108 | ) | 438,000 | 2,898,892 | |||||||||||
| Total other income, net | 172,317 | (8,250,746 | ) | 969,324 | 1,234,340 | |||||||||||
| Net loss | $ | (7,262,658 | ) | $ | (12,638,357 | ) | $ | (19,019,785 | ) | $ | (18,725,716 | ) | ||||
| Net loss per share | ||||||||||||||||
| Basic | $ | (0.37 | ) | $ | (0.97 | ) | $ | (1.01 | ) | $ | (1.64 | ) | ||||
| Diluted | $ | (0.37 | ) | $ | (0.97 | ) | $ | (1.01 | ) | $ | (1.89 | ) | ||||
| Weighted-average number of common shares used in computing net loss per share | ||||||||||||||||
| Basic | 19,685,071 | 12,975,808 | 18,876,078 | 11,394,729 | ||||||||||||
| Diluted | 19,685,071 | 12,975,808 | 18,876,078 | 11,461,298 | ||||||||||||
FAQ
What clinical milestones did ANVS report on November 12, 2025?
How much cash does ANVS have and how long will it fund operations?
What were ANVS Q3 2025 R&D and G&A expense figures?
What intellectual property update did ANVS announce for buntanetap?
Did ANVS report any clinical biomarker results for buntanetap?
How many ANVS shares were outstanding as of Sep 30, 2025?
How did ANVS’s net loss per share change year-over-year in Q3?
