Annovis Bio, Inc.

Previous wording

We are a late-stage clinical company addressing neurodegeneration, such as Alzheimer’s disease (“AD”) and Parkinson’s disease (“PD”). We are developing our lead product candidate, buntanetap, which is designed to address AD, PD, and potentially other chronic neurodegenerative diseases. Buntanetap is a synthetically produced small molecule, orally administered, brain penetrant compound. In several studies, buntanetap was observed to inhibit the synthesis of neurotoxic proteins — APP/Aβ (“APP”), tau/phospho-tau (“tau”), α-Synuclein (“αSYN”) and TDP43 — that are some of the main causes of neurodegeneration. High levels of neurotoxic proteins lead to reduced axonal transport, which is responsible for the communication between and within nerve cells. When that communication is compromised, the immune system is activated and attacks the nerve cells, eventually killing them. We have observed in our completed clinical studies in AD and PD patients and pre-clinical studies in mice and rats that buntanetap lowered neurotoxic protein levels leading to improved axonal transport, reduced inflammation, lower nerve cell death and improved affected functions.

Current wording

We are a late-stage clinical company addressing neurodegeneration, such as Alzheimer’s disease (“AD”) and Parkinson’s disease (“PD”). We are developing our lead drug candidate, buntanetap, which is designed to address AD, PD, and potentially other chronic neurodegenerative diseases. Buntanetap is a synthetically produced small molecule, orally administered, brain penetrant compound. In several studies, buntanetap was observed to inhibit the synthesis of neurotoxic proteins — APP/Aβ (“APP”), tau/phospho-tau (“tau”), α-Synuclein (“αSYN”) and TDP43 — that are some of the main causes of neurodegeneration. High levels of neurotoxic proteins lead to reduced axonal transport, which is responsible for the communication between and within nerve cells. When that communication is compromised, the immune system is activated and attacks the nerve cells, eventually killing them. We have observed in our completed clinical studies in AD and PD patients and pre-clinical studies in mice and rats that buntanetap lowered neurotoxic protein levels leading to improved axonal transport, reduced inflammation, lower nerve cell death, and improved affected functions.

Previous wording

Currently we are conducting two clinical studies – a pivotal Phase 3 study in early AD ("Phase 3AD Trial”) (NCT06709014) and an open-label extension ("OLE”) study in PD (NCT07284784), and we plan for a third study in Parkinson’s disease dementia ("PDD”).

Current wording

To date, we have concluded 11 clinical studies – in healthy volunteers to assess safety, food effect, pharmacokinetics ("PK”), distribution, etc., and in AD and PD patients to assess safety and efficacy. Currently we are conducting two clinical studies – a pivotal Phase 3 study in early AD ("Phase 3 AD Study”) (NCT06709014) and an open-label extension ("OLE”) study in PD patients (“OLE PD Study”) (NCT07284784). We will also initiate an OLE study in AD patients (“OLE AD Study”) in October 2026, and we plan for a new study in Parkinson’s disease dementia ("PDD”). The most important clinical studies are described below:

Previous wording

Our Phase 2/3 AD study was completed on February 13, 2024, and on April 29, 2024, we announced topline efficacy data. The data showed that in early AD patients, buntanetap improved ADAS-Cog11 in a dose-dependent fashion and was statistically significant from placebo and from baseline.

Current wording

In February 2023, we initiated a Phase 2/3 trial in mild to moderate AD patients (our “Phase 2/3 AD Study”), who were defined as those with a Mini Mental State Examination (“MMSE”) score from 14 to 24. Our Phase 2/3 AD Study was completed on February 13, 2024, and on April 29, 2024, we announced the topline efficacy data. The data showed that in early AD patients, defined by the MMSE score from 21 to 24, with confirmed elevated levels of plasma phosphorylated tau217 (“p-tau217”) biomarker, buntanetap improved cognition as measured by Alzheimer’s Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog11) in a dose-dependent fashion and was statistically significant from placebo and from baseline. ADAS-Cog is an assessment scale that measures cognitive functions and non-cognitive functions such as mood and behavior. More specifically, ADAS-Cog11 is the cognitive assessment scale used to measure areas commonly seen to decline in AD patients. It consists of 11 specific tasks such as word recall, comprehension, object-naming, etc., in order to produce a scale measurement. We also saw that treatment with buntanetap reduced biomarkers of neurotoxic proteins, inflammation, and axonal injury.

Previous wording

On October 10, 2024, we met with the FDA in an end-of-phase 2 meeting to discuss its Phase 2/3 AD data and to agree on a regulatory path forward. Annovis and the FDA have aligned on a development path for buntanetap towards the filing of two NDAs, one for short-term and one for long-term efficacy. During the end-of-phase 2 meeting for AD, the FDA raised no concerns with our data on buntanetap’s safety, including impact on liver enzymes, drug interactions, dose selection, PK, and population PK. Further, the FDA confirmed that future development can proceed using the new crystal form of buntanetap.

Current wording

On October 10, 2024, we met with the FDA in an end-of-phase 2 meeting to discuss our Phase 2/3 AD data and to agree on a regulatory path forward. Annovis and the FDA have aligned on a development path for buntanetap towards the filing of two New Drug Applications (“NDA”) – one for short-term symptomatic and one for long-term disease-

Previous wording

In February of 2025, we initiated the FDA-cleared pivotal Phase 3 AD Trial: a randomized, double-blind, placebo-controlled, multicenter Phase 3 study in 725 early AD patients. The trial investigates buntanetap and consists of two parts: a 6-month treatment period aimed at confirming buntanetap’s symptomatic efficacy, followed by an additional 12 months of treatment to show potential disease-modifying efficacy at 18 months. After the 6-month treatment period has been completed, patients will continue to be blinded for an additional 12 months. If well-designed and well-executed, the symptomatic portion of the trial may be sufficient to support a New Drug Application ("NDA”) filing, potentially within one year of the 6-month treatment period completion. A similar pathway could be available after 18 months, where a second NDA for disease modification may be supportable with a well-designed and well-executed long-term portion of the trial. The Phase 3 AD Trial is currently enrolling patients, with screening expected to conclude on May 15, 2026, and full enrollment anticipated two months thereafter.

Current wording

In February 2025, we initiated the FDA-cleared pivotal Phase 3 AD Study: a randomized, double-blind, placebo-controlled, multicenter Phase 3 trial in early AD patients with the MMSE score from 20 to 28. Patients are also screened for plasma p-tau217 biomarker, indicating amyloid and tau pathology in the brain. The trial investigates a single dose of buntanetap (30 mg) and consists of two parts: a 6-month treatment period aimed at confirming buntanetap’s symptomatic efficacy, followed by an additional 12 months of treatment to show its disease-modifying efficacy at 18 months. After the 6-month treatment period has been completed, patients continue to be blinded for an additional 12 months. This pivotal Phase 3 AD Study utilizes standard clinical outcome measures including ADAS-Cog13 and Alzheimer’s Disease Cooperative Study-Instrumental Activities of Daily Living Scale (“ADCS-iADL”), which measure cognition and function, respectively. Volumetric MRI imaging and certain plasma biomarkers are also being assessed, including p-tau217 levels and inflammatory markers, leveraging recent biomarker assay advances in AD to better diagnose Alzheimer’s patients and disease progression. If well-designed and well-executed, the symptomatic portion of the trial may be sufficient to support an NDA filing, potentially within one year of the 6-month treatment period completion. A similar pathway could be available after 18 months, where a second NDA for disease modification may be supportable with a well-designed and well-executed long-term portion of the trial. As of July 2026, the Phase 3 AD Study is fully enrolled with a total of 860 early AD patients.

Previous wording

Our Phase 3 PD Study was completed on December 4, 2023, and we released the topline PD Study efficacy data on July 2, 2024. The study data showed that in two subgroups buntanetap improved UPDRS Part II, III, II+III and total. It also showed that in the entire intent to treat (“ITT”) population, buntanetap stopped the loss of cognition and that in the 12% of patients that already had cognitive issues, buntanetap improved cognition in a dose-dependent, statistically significant way. We asked the FDA for a Type C meeting to discuss the data and the continued development of

Current wording

In August 2022, we initiated a Phase 3 study in early PD patients (our “Phase 3 PD Study”), defined as those at Hoehn & Yahr stages 1, 2 or 3 and OFF times of less than two hours per day. The Hoehn & Yahr scale is a medical assessment used to measure staging of the functional disability associated with PD where a higher stage indicates greater disease severity. OFF time refers to periods when PD motor and/or non-motor symptoms occur between medication doses. Our Phase 3 PD Study was completed on December 4, 2023, and the topline efficacy data were released on July 2, 2024. The study data showed that in two subgroups buntanetap improved motor function on the Movement Disorder Society - Unified Parkinson’s Disease Rating Scale (“MDS-UPDRS”) Part II, III, II+III and total. MDS-UPDRS is designed to assess PD-related disability and impairment and also to evaluate the activities of daily living and motor function. The study data also showed that in the entire intent-to-treat population buntanetap stopped the loss of cognition and that in the 12% of patients who already had cognitive issues, buntanetap improved cognition in a dose-dependent, statistically significant way.

Previous wording

In 2025, we further discussed a study in PDD with the FDA. After showing that the amyloid-positive PD population with the Mini Mental State Examination ("MMSE”) score above 20 responds exceptionally well to our drug, buntanetap, we received approval to proceed. We are refining the proposed protocol for the PDD program and will initiate the study contingent on additional funding.

Current wording

After the study completion, we requested a Type C meeting with the FDA to discuss the data and the continued development of buntanetap for Lewy body dementia (“LBD”). In response, we received a letter from the FDA saying that because LBD is a challenging disease to treat and because there are no accepted endpoints, they would like to discuss the two conditions — dementia with Lewy bodies and PDD — separately and independently. After showing that the p-tau217-positive PD population with the MMSE score above 20 responds particularly well to our drug, buntanetap, we received approval to proceed. We are refining the proposed protocol for the PDD program and will initiate the study contingent on additional funding.

Previous wording

In January of 2026, we began an OLE study to evaluate the long-term safety and efficacy of buntanetap in PD patients. The study aims to enroll 500 patients, who will be treated with buntanetap for 36 months or until buntanetap is on the market. The patient population consists of two cohorts: cohort 1with invited participants from prior clinical

Current wording

In 2025, the FDA also approved a protocol for an OLE PD Study, which we initiated in January 2026. The study aims to enroll 500 patients, who are treated with buntanetap for 36 months or until buntanetap is on the market. The patient population consists of two cohorts: cohort 1 with invited participants from prior clinical studies and cohort 2 with patients who did not take part in earlier trials but have been receiving deep brain stimulation for at least 12 months following successful surgery. The primary objective of the OLE PD Study is to measure safety of buntanetap. The study also includes exploratory measures including cognition, movement, and innovative biomarkers, such as a NeuroRPM digital biomarker to assess PD symptoms in real time and a skin biopsy test to measure levels of αSYN – a hallmark of

Previous wording

studies and cohort 2 with patients who did not take part in earlier trials but have been receiving deep brain stimulation ("DBS”) for at least 12 months following successful surgery. The OLE PD study represents an important step toward a future NDA submission by helping meet the FDA patient exposure requirements.

Current wording

PD pathology. The OLE PD Study represents an important step toward a future NDA submission by helping meet the FDA patient exposure requirements.

Previous wording

In 2021, we completed two Phase 1/2 clinical studies: one in 14 early AD patients and one in 54 early PD patients (together, the “AD/PD Trials”). In the AD/PD Trials, early AD patients were defined as those with a MMSE score between 19 and 28 and early PD patients as those patients at Hoehn & Yahr stages 1, 2 or 3. MMSE is a brief screening instrument used to assess cognitive function, with total scores ranging from 0 to 30 and a lower score indicating greater disease severity, while the Hoehn & Yahr scale is a medical assessment used to measure staging of the functional disability associated with PD where a higher stage indicates greater disease severity. In collaboration with the Alzheimer’s Disease Cooperative Study (“ADCS”), we also conducted a trial in 16 early AD patients (the “ADCS Trial”). In the ADCS Trial, early AD patients were defined as those patients with an MMSE score between 19 and 28. At the completion of the ADCS Trial, the data showed that buntanetap acts as a translational inhibitor in humans just like in animals, and we further observed that there was statistical improvement in cognition in early AD patients, just like in the AD/PD Trials.

Current wording

In 2021, we completed two Phase 1/2 clinical studies: one in 14 early AD patients and one in 54 early PD patients (together, the “AD/PD Trials”). In the AD/PD Trials, early AD patients were defined as those with the MMSE score between 19 and 28 and early PD patients as those at Hoehn & Yahr stages 1, 2 or 3.

Previous wording

All three clinical trials above were double-blind and placebo-controlled. We designed the studies by applying our understanding of the underlying neurodegenerative disease states and measured both target and pathway validation in the spinal fluid of patients to determine whether patients underlying disease condition improved following treatment. In addition to meeting their primary endpoints of safety and tolerability and secondary endpoint of PK of buntanetap, our AD/PD Trials also met exploratory endpoints of measures of biomarkers and improvements in cognition in AD patients, as well as function in PD patients. We believe that the AD/PD Trials represent the first double-blind, placebo-controlled study that showed improvements in AD patients, as measured by ADAS-Cog and in PD patients, as measured by Unified Parkinson’s Disease Rating Scale (“MDS-UPDRS” or “UPDRS”). ADAS-Cog is an assessment scale that measures cognitive functions and non-cognitive functions such as mood and behavior. More specifically, ADAS-Cog-11 is the cognitive assessment scale used to measure areas commonly seen to decline in AD patients. It consists of 11 specific tasks such as word recall, comprehension, object-naming, etc., in order to produce a scale measurement. UPDRS Part II and III are composed of a 42-item rating scale designed to assess PD-related disability and impairment and also evaluate the activities of daily living and motor function.

Current wording

All three clinical trials above were double-blind and placebo-controlled. We designed the studies by applying our understanding of the underlying neurodegenerative disease states and measured both target and pathway validation in the spinal fluid of patients to determine whether patients’ underlying disease condition improved following treatment. In addition to meeting their primary endpoints of safety and tolerability and secondary endpoint of PK of buntanetap, our AD/PD Trials also met exploratory endpoints of measures of biomarkers and improvements in cognition in AD patients, as well as function in PD patients. We believe that the AD/PD Trials represent the first double-blind, placebo-controlled study that showed improvements in AD patients, as measured by ADAS-Cog and in PD patients, as measured by MDS-UPDRS.

Previous wording

Following completion of the AD/PD Trials, we submitted our data to the FDA and requested direction to further pursue the development of buntanetap in early PD patients. With the FDA’s guidance, we initiated a Phase 3 study in early PD patients in August 2022 (our “Phase 3 PD Study”). In the Phase 3 PD Study, early PD patients were defined as those at Hoehn & Yahr stages 1, 2 or 3 and OFF times of less than two hours per day. OFF time refers to periods when PD motor and/or non-motor symptoms occur between medication doses. We also submitted a proposed protocol for the treatment of moderate AD to the FDA, and after receiving permission to proceed, we initiated a Phase 2/3 study in mild to moderate AD patients in February 2023 (our “Phase 2/3 AD Study”). In the Phase 2/3 AD Study, mild to moderate AD patients were defined as those with an MMSE score between 14 and 24. Our Phase 3 PD Study and Phase 2/3 AD Study each had built-in interim analyses.

Current wording

Following the completion of the AD/PD Trials, we submitted our data to the FDA and requested direction to further pursue the development of buntanetap in early PD patients. After approval, we initiated the Phase 3 PD Study in August 2022. We also submitted a proposed protocol for the treatment of AD to the FDA, and after receiving permission to proceed, we initiated the Phase 2/3 AD Study in February 2023.

Previous wording

We have never been profitable and have incurred net losses since inception. Our accumulated deficit at March 31, 2026 was $181.3 million. We do not have sufficient capital on hand to fund our operations for the next 12 months and will need to raise additional capital to meet our obligations as they become due. We believe that our cash and cash equivalents will be sufficient to fund our operating expenses and capital expenditure requirements until the fourth quarter of 2026. We will need to raise substantial additional capital to complete the development and commercialization of our product candidates through public or private equity offerings, debt financings, collaboration and licensing arrangements or other financing alternatives. However, there can be no assurance that we will be successful in raising additional capital or that such capital, if available, will be on terms that are acceptable to us. If we are unable to raise sufficient additional capital or defer sufficient operating expenses, we may be compelled to reduce the scope of, or cease, our operations. Accordingly, we have concluded that substantial doubt exists with respect to our ability to continue as a going concern within one year after the date that these financial statements are issued.

Current wording

We have never been profitable and have incurred net losses since inception. Our accumulated deficit at June 30, 2026 was $196.1 million. We do not have sufficient capital on hand to fund our operations for the next 12 months and will need to raise additional capital to meet our obligations as they become due. We believe that our cash and cash equivalents will be sufficient to fund our operating expenses and capital expenditure requirements until the fourth quarter of 2026. We will need to raise substantial additional capital to complete the development and commercialization of our product candidates through public or private equity offerings, debt financings, collaboration and licensing arrangements or other financing alternatives. However, there can be no assurance that we will be successful in raising additional capital or that such capital, if available, will be on terms that are acceptable to us. If we are unable to raise sufficient additional capital or defer sufficient operating expenses, we may be compelled to reduce the scope of, or cease, our operations. Accordingly, we have concluded that substantial doubt exists with respect to our ability to continue as a going concern within one year after the date that these financial statements are issued.

Previous wording

Interest income was $0.1 million for the three months ended March 31, 2026, compared to $0.2 million for the three months ended March 31, 2025. The $0.1 million decrease was driven by lower cash and cash equivalent balances at March 31, 2026 as compared to March 31, 2025, as the March 31, 2025 balance reflected additional funds as a result of our public offering with ThinkEquity, which closed in February 2025. Cash balances have declined since March 31, 2025 due to cash payments to fund our studies.

Current wording

Interest income was $0.2 million for the three months ended June 30, 2026, compared to $0.2 million for the three months ended June 30, 2025. Cash and cash equivalent balances were similar at June 30, 2026 and June 30, 2025, due to additional funds as a result of the public offerings with Canaccord, which closed in April 2026 and May 2026, as compared to our public offering with ThinkEquity, which closed in February 2025.

Previous wording

Change in fair value of warrants was a gain of $0.3 million for the three months ended March 31, 2026, compared to a gain of $0.6 million for the three months ended March 31, 2025. The $0.3 million difference between periods was primarily driven by greater volatility in our stock price during the first quarter of 2025, as compared to the same period during 2026.

Current wording

Change in fair value of warrants was a gain of $1.0 million for the three months ended June 30, 2026, compared to a loss of $0.1 million for the three months ended June 30, 2025. The $1.1 million difference between periods was primarily driven by the decrease in our stock price during the second quarter of 2026 and the impact of the stock price on the increase in liability classified warrants, as compared to the same period during 2025.

Previous wording

Research and development expenses for the three months ended March 31, 2026 were $16.7 million, compared to $5.0 million for the three months ended March 31, 2025. The $11.7 million increase was primarily attributable to an increase of $11.9 million for costs associated with our AD 6 month trial patients, an increase of $2.2 million for costs associated with our PD OLE trial, and a decrease of $2.4 million in clinical costs not specifically associated with either study.

Current wording

Research and development expenses for the six months ended June 30, 2026 were $28.7 million, compared to $10.1 million for the six months ended June 30, 2025. The $18.6 million increase was primarily attributable to an increase of $15.2 million for costs associated with increased recruitment in our AD 6/18 month trial patients, an increase of $4.2 million for costs associated with our PD OLE trial, and a decrease of $1.0 million in clinical manufacturing costs.

Previous wording

Since our inception in 2008, we have devoted most of our cash resources to research and development and general and administrative activities. We have financed our operations primarily with the proceeds from the sale of common stock and warrants. To date, we have not generated any revenue from the sale of products, and we do not anticipate generating any revenue from the sale of products for the foreseeable future. We have incurred losses and generated negative cash flows from operations since inception. As of March 31, 2026, our principal source of liquidity was our cash and cash equivalents, which totaled $14.2 million. We do not believe that our cash on hand will be sufficient to fund our operations for at least twelve months beyond the date of this filing.

Current wording

Since our inception in 2008, we have devoted most of our cash resources to research and development and general and administrative activities. We have financed our operations primarily with the proceeds from the sale of common stock and warrants. To date, we have not generated any revenue from the sale of products, and we do not anticipate generating any revenue from the sale of products for the foreseeable future. We have incurred losses and generated negative cash flows from operations since inception. As of June 30, 2026, our principal source of liquidity was our cash and cash equivalents, which totaled $18.7 million. We do not believe that our cash on hand will be sufficient to fund our operations for at least twelve months beyond the date of this filing.

Previous wording

On April 9, 2026, the Company entered into an Underwriting Agreement with Canaccord Genuity LLC (“Canaccord”), with respect to an underwritten public offering of 5.3 million units of the Company, each unit consisting of one share of its common stock, par value $0.0001 per share and one warrant to purchase one share of the Company Stock (the “Canaccord 2026 Warrants”). The units were priced at $1.90 per unit and the offering resulted in gross proceeds of $10.0 million, before deducting underwriting discounts, fees and other related expenses. Net proceeds from the transaction totaled $9.3 million. The Canaccord 2026 Warrants have an exercise price of $2.50 per share, are exercisable after six months from their issuance date, and expire five and one half years from their date of issuance.

Current wording

On April 9, 2026, the Company entered into an Underwriting Agreement with Canaccord Genuity LLC (“Canaccord”), with respect to an underwritten public offering of 5.3 million units of the Company, each unit consisting of one share of its common stock, par value $0.0001 per share and one warrant to purchase one share of the Company Stock (the “April 2026 Canaccord Warrants”). The units were priced at $1.90 per unit and the offering resulted in gross proceeds of $10.0 million, before deducting underwriting discounts, fees and other related expenses. Net proceeds from the transaction totaled $9.2 million. The Canaccord 2026 Warrants have an exercise price of $2.50 per share, are exercisable after six months from their issuance date, and expire five and one half years from their date of issuance.

Previous wording

On October 26, 2025, the Company entered into (i) a Securities Purchase Agreement, with the purchasers signatory thereto pursuant to which the Company agreed to issue and sell, in a registered direct offering an aggregate of 597,561 shares of the Company’s common stock, $0.0001 par value per share and (ii) Stock Subscription Agreements (the "Subscription Agreements”) with two members of the Board of Directors of the Company pursuant to which they agree to purchase an aggregate of 1,073,171 shares of Common Stock. An aggregate number of 1,670,732 shares of Common Stock was issued. The offering price of each share was $2.05 per share. In addition, in connection with this offering, the Company granted to a placement agent, warrants to purchase a total 83,357 shares of Common Stock (the "October 26, 2025 Placement Agent Warrants”) that have an exercise price per share equal to $2.56 and a term of 5 years from the date of issuance. The aggregate fair market value was recorded as an offset to gross proceeds of the Offering and an increase to additional paid-in capital. The net proceeds to the Company from the Offering were $3.1 million.

Current wording

597,561 shares of the Company’s common stock, $0.0001 par value per share and (ii) Stock Subscription Agreements (the "Subscription Agreements”) with two members of the Board of Directors of the Company pursuant to which they agree to purchase an aggregate of 1,073,171 shares of Common Stock. An aggregate number of 1,670,732 shares of Common Stock was issued. The offering price of each share was $2.05 per share. In addition, in connection with this offering, the Company granted to a placement agent, warrants to purchase a total 83,537 shares of Common Stock (the "October 26, 2025 Placement Agent Warrants”) that have an exercise price per share equal to $2.56 and a term of 5 years from the date of issuance. The aggregate fair market value was recorded as an offset to gross proceeds of the Offering and an increase to additional paid-in capital. The net proceeds to the Company from the Offering were $3.1 million.

Previous wording

During the three months ended March 31, 2026, the Company sold 1.3 million shares of common stock pursuant to the Distribution Agreement for gross proceeds of $3.8 million, before commissions. During the year-ended December 31, 2025, the Company sold 2.1 million shares of common stock pursuant to the Distribution Agreement for gross proceeds of $6.8 million before commissions.

Current wording

During the three and six months ended June 30, 2026, the Company sold 0.8 million and 2.2 million shares of common stock pursuant to the Distribution Agreement for gross proceeds of $1.8 million and $5.6 million, respectively, before commissions. During the year-ended December 31, 2025, the Company sold 2.1 million shares of common stock pursuant to the Distribution Agreement for gross proceeds of $6.8 million before commissions.

Previous wording

The following table provides a summary of our cash flows for the three months ended March 31, 2026 and 2025:

Current wording

The following table provides a summary of our cash flows for the six months ended June 30, 2026 and 2025:

Previous wording

Cash used in operating activities was $9.0 million for the three months ended March 31, 2026, compared to $8.1 million for the three months ended March 31, 2025 The $0.9 million increase in cash used in operations was primarily the result of additional cash paid for clinical trials and related expenses, given the planned timing of study costs and related disbursements.

Current wording

Cash used in operating activities was $30.9 million for the six months ended June 30, 2026, compared to $13.2 million for the six months ended June 30, 2025 The $17.7 million increase in cash used in operations was primarily the result of additional cash paid for clinical trials and related expenses, given the planned timing of study costs and related disbursements.

Previous wording

Contingent upon continued achievement of our fundraising requirements, we expect cash used in operating activities to remain at elevated levels as 2026 progresses, due to expected operating expenditures associated with continued development of our product candidates. More specifically, we expect elevated operating cash burn as a result of costs associated with completing our active Phase 3 AD Trial.

Current wording

Contingent upon continued achievement of our fundraising requirements, we expect cash used in operating activities to remain at elevated levels as 2026 progresses, due to expected operating expenditures associated with continued development of our product candidates. More specifically, we expect elevated operating cash burn as a result of costs associated with completing our active Phase 3 AD Study.

Previous wording

Cash provided by financing activities for the three months ended March 31, 2026 was $3.7 million and primarily consisted of $3.7 million of proceeds from our Distribution Agreement with OpCo. Cash provided by financing activities for the three months ended March 31, 2025, was $19.8 million and primarily consisted of proceeds from our registered offering with ThinkEquity, as well as proceeds from our Distribution Agreement facility with OpCo.

Current wording

Cash provided by financing activities for the six months ended June 30, 2026 was $30.1 million and primarily consisted of $24.6 million of net proceeds from our Underwritten Offerings with Canaccord in April and May 2026, as well as $5.5 million of net proceeds from our ATM facility with OpCo. Cash provided by financing activities for the six months ended June 30, 2025, was $19.8 million and primarily consisted of proceeds from our registered offering with ThinkEquity, as well as proceeds from our Distribution Agreement facility with OpCo.