Alto Neuroscience, Inc.
For the period ended Sep 30, 2025. Filed Nov 12, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Nov 12, 2025
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-13.
0001999480-25-000076
Item 2. Management's Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-12.
0001999480-25-000090
Item 2. Management's Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 183 previous paragraphs and 192 current paragraphs.
139 unchanged; 34 reworded; 15 added; 9 removed; 1 previous and 4 current paragraphs rearranged.
Tables are not compared: 5 previous and 5 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (15)
Current report
Recent Developments
Current report
October 2025 Private Placement
Current report
In October 2025, we entered into a Securities Purchase Agreement, or the Purchase Agreement, with certain institutional and other accredited investors, or the Purchasers, pursuant to which we agreed to sell and issue to the Purchasers in a private placement transaction, or Private Placement: (i) 3,832,263 shares of our common stock and (ii) with respect to certain Purchasers, pre-funded warrants to purchase 4,622,251 shares of common stock, or Pre-Funded Warrants, in lieu of shares of common stock. The purchase price per share of common stock was $5.9140 per share, or the Purchase Price, and the purchase price for the Pre-Funded Warrants was $5.9139 per Pre-Funded Warrant. The closing of the Private Placement occurred on October 21, 2025. The total gross proceeds to us at the Closing were approximately $50.0 million, and, after deducting offering expenses payable by us, net proceeds were approximately $49.9 million.
Current report
In October 2025, we announced that a blinded pharmacokinetic, or PK, analysis from the first cohort of patients in our ongoing Phase 2b study evaluating ALTO-100 as a treatment for BPD demonstrated that 96% of samples for ALTO-100 qualified as PK positive. A sample was considered PK positive if observed drug levels were above a pre-specified minimum threshold. We believe these results underscore the effectiveness of the operational adjustments made to trial design and execution following the completion of the ALTO-100 MDD Phase 2b trial. Enrollment in this trial is ongoing, with a target of approximately 200 patients, and we expect to report topline data from the study in the second half of 2026.
Current report
In September 2025, we announced positive results from an independent, prospective replication study evaluating EEG biomarkers in people with schizophrenia. The study successfully replicated previous findings, demonstrating that event-related theta-band responses, particularly theta-band inter-trial coherence, or ITC, robustly differentiate people with schizophrenia from healthy individuals. The results support the use of this objective, brain-based measurement in identifying and evaluating patients.
Current report
In October 2025, the FDA granted Fast Track designation to ALTO-101 for the treatment of CIAS. Also in October 2025, we announced that a blinded PK analysis from the first cohort of patients in our ongoing trial evaluating ALTO-101 as a treatment for CIAS demonstrated that 100% of samples tested for ALTO-101 qualified as PK positive. We believe these positive results demonstrate patient receptivity and engagement with the treatment regimen. Enrollment remains ongoing and we expect to report topline data from this study in the first quarter of 2026.
Current report
•an increase of approximately $0.3 million in expenses related to development of our ALTO-207 program ; and
Current report
•an increase of approximately $0.8 million in expenses related to early research.
Current report
Comparison of the Nine Months Ended September 30, 2025 and 2024
Current report
•a decrease of approximately $3.5 millionin clinical development related expenses primarily driven by the completion of our ALTO-100 Phase 2b trial in MDD and our ALTO-203 Phase 2 POC clinical trial; and
Current report
•an increase of approximately $1.0 million in asset acquisition and licensing fees primarily driven by fees related to the Chase asset acquisition during the nine months ended September 30, 2025; and
Current report
General and administrative expenses were $15.7 million for the nine months ended September 30, 2025, compared to $15.4 million for the nine months ended September 30, 2024.
Current report
Private Placement
Current report
In October 2025, we entered into the Purchase Agreement with the Purchasers pursuant to which we agreed to sell and issue to the Purchasers in the Private Placement: (i) 3,832,263 shares of our common stock and (ii) with respect to certain Purchasers, Pre-Funded Warrants to purchase 4,622,251 shares of common stock in lieu of shares of common stock. The Purchase Price was $5.9140 per share and the purchase price for the Pre-Funded Warrants was $5.9139 per Pre-Funded Warrant. . The Private Placement closed on October 21, 2025. The total gross proceeds to us at the Closing were approximately $50.0 million, and, after deducting offering expenses payable by us, net proceeds were approximately $49.9 million.
Current report
Shelf Registration Statement
Removed paragraphs (9)
Previous report
•a decrease of approximately $0.6 million related to ALTO-100 primarily driven by the completion of the Phase 2b trial in MDD, in the fourth quarter of 2024;
Previous report
•a decrease of $0.3 million related our Phase 2 POC clinical trial of ALTO-203 which completed during the three months ended June 30, 2025.
Previous report
•an increase of approximately $1.0 million due to acquisition fees paid in connection with the Chase asset acquisition during the three months ended June 30, 2025 compared to amounts paid during the three months ended June 30, 2024 in connection with development milestones achieved under licensing agreements covering ALTO-101 and ALTO-203; and
Previous report
General and administrative expenses were $5.6 million for the three months ended June 30, 2025, compared to $5.2 million for the three months ended June 30, 2024. The increase of $0.4 million was primarily due to an increase in salary and personnel-related costs, which includes an increase in severance of $0.2 million.
Previous report
Comparison of the Six Months Ended June 30, 2025 and 2024
Previous report
•an increase of approximately $1.0 million due to acquisition fees paid in connection with the Chase asset acquisition during the six months ended June 30, 2025 compared to amounts paid during the six months ended June 30, 2024 in connection with development milestones achieved under licensing agreements covering ALTO-101 and ALTO-203; and
Previous report
•an increase of approximately $1.4 million in salary and personnel related costs due to increased headcount as well as $0.1 million of non-cash stock-based compensation.
Previous report
•an increase of approximately $1.0 million in professional fees and other expenses.
Previous report
Shelf Registration Statement and Sales Agreement
Reworded paragraphs (34)
Previous wording
We are a clinical-stage biopharmaceutical company with a mission to redefine psychiatry by leveraging neurobiology to develop personalized and highly effective treatment options. Through insights derived from our scalable and proprietary Precision Psychiatry Platform, or our Platform, we aim to discover brain-based biomarkers to better identify which patients are more likely to respond to our novel product candidates. Our current pipeline consists of seven clinical-stage assets addressing high-need therapeutic areas, focusing on major depressive disorder, or MDD, bipolar depression, or BPD, treatment resistant depression, or TRD, and schizophrenia. Our most advanced programs are supported by prospectively replicated evidence of clinical activity in biomarker-characterized populations.
Current wording
We are a clinical-stage biopharmaceutical company with a mission to redefine psychiatry by leveraging neurobiology to develop personalized and highly effective treatment options. Through insights derived from our scalable and proprietary Precision Psychiatry Platform, or our Platform, we aim to discover brain-based biomarkers to better identify which patients are more likely to respond to our novel product candidates. Our current pipeline consists of seven clinical-stage assets addressing high-need therapeutic areas, focusing on major depressive disorder, or MDD, bipolar depression, or BPD, treatment resistant depression, or TRD, and schizophrenia.
Previous wording
In May 2025, we acquired ALTO-207 (formerly known as CTC-501) from Chase Therapeutics Corporation, or Chase. ALTO-207 is afixed-dose combination of pramipexole, a dopamine D3-preferring D3/D2 agonist, approved for the treatment of Parkinson’s disease with demonstrated antidepressant effect, and ondansetron, an antiemetic, selective 5-HT3 receptor antagonist. As a fixed-dose combination, ALTO-207 is designed to enable rapid titration and higher dosing by mitigating the dose-limiting adverse events typically experienced with pramipexole. ALTO-207 is being developed to address the significant unmet need for patients with TRD. The planned Phase 2b trial of ALTO-207, which is a potentially pivotal study subject to FDA feedback approval, is expected to initiate by mid-2026.
Current wording
In May 2025, we acquired ALTO-207 (formerly known as CTC-501) from Chase Therapeutics Corporation, or Chase. ALTO-207 is afixed-dose combination of pramipexole, a dopamine D3-preferring D3/D2 agonist, approved for the treatment of Parkinson’s disease with demonstrated antidepressant effect, and ondansetron, an antiemetic, selective 5-HT3 receptor antagonist. As a fixed-dose combination, ALTO-207 is designed to enable rapid titration and higher dosing by mitigating the dose-limiting adverse events typically experienced with pramipexole. ALTO-207 is being developed to address the significant unmet need for patients with TRD. The planned Phase 2b trial of ALTO-207, which has the potential to serve as a pivotal trial subject to U.S. Food and Drug Administration, or FDA, feedback and review of data, is expected to initiate in the first half of-2026. Following a recent FDA meeting, we also expect to initiate a Phase 3 trial by early 2027 following Phase 3 readiness work and alignment with the FDA on the planned trial design.
Previous wording
Our acquisition of ALTO-207 was motivated by the PAX-D study conducted by the University of Oxford. Results, which were recently published in The Lancet Psychiatry, showed pramipexole augmentation of antidepressant treatment, at a target dose of 2.5mg, demonstrated a large (Cohen’s d=0.87) reduction in symptoms relative to placebo at 12 weeks, but was associated with a high rate of adverse effects. We believe the profile of ALTO-207 will enable higher dosing of pramipexole while mitigating the significant rates of nausea and vomiting that have limited its use for depression.
Current wording
Our acquisition of ALTO-207 was motivated by the results from the PAX-D study conducted by the University of Oxford. Results, which were recently published in The Lancet Psychiatry, showed pramipexole augmentation of antidepressant treatment, at a target dose of 2.5mg, demonstrated a large (Cohen’s d=0.87) reduction in symptoms relative to placebo at 12 weeks, but was associated with a high rate of adverse effects. We believe the profile of ALTO-207 will enable higher dosing of pramipexole while mitigating the significant rates of nausea and vomiting that have limited its use for depression.
Previous wording
We are currently evaluating ALTO-100 in a Phase 2b trial in patients with BPD in which patients are assigned to take ALTO-100 as adjunctive treatment to a stable dose of a background mood stabilizing treatment over a six-week treatment period. BPD is associated with memory, cognitive, and neuroplasticity abnormalities at similar or greater rates than seen in MDD. Much like MDD, poor memory and cognition patients typically experience greater treatment resistance and disability, with overall worse outcomes. Moreover, the only currently approved therapies are antipsychotics. We believe the pro-neuroplasticity mechanism of ALTO-100 has the potential to address the high unmet need in this important patient population. Enrollment in this trial is ongoing, with a target of approximately 200 patients, and we expect to report topline data from the study in the second half of 2026.
Current wording
We are currently evaluating ALTO-100 in a Phase 2b trial in patients with BPD in which patients are assigned to take ALTO-100 as adjunctive treatment to a stable dose of a background mood stabilizing treatment over a six-week treatment period. BPD is associated with memory, cognitive, and neuroplasticity abnormalities at similar or greater rates than seen in MDD. Much like MDD, poor memory and cognition patients typically experience greater treatment resistance and disability, with overall worse outcomes. Moreover, the only currently approved therapies are antipsychotics. We believe the pro-neuroplasticity mechanism of ALTO-100 has the potential to address the high unmet need in this important patient population.
Previous wording
We are currently evaluating ALTO-203 for the treatment of patients with MDD associated with increased levels of anhedonia. In June 2025, we announced the identification of a patient selection biomarker and positive pharmacodynamic results from our exploratory Phase 2 proof-of-concept, or POC, trial of ALTO-203 in MDD patients with elevated levels of anhedonia. ALTO-203 is a novel, oral, histamine H3 inverse agonist, designed to modulate circuits underlying cognition, wakefulness, and alertness.
Current wording
ALTO-203 is a novel, oral, histamine H3 inverse agonist, designed to modulate circuits underlying cognition, wakefulness, and alertness. In June 2025, we announced the identification of a patient selection biomarker and positive pharmacodynamic results from our exploratory Phase 2 proof-of-concept, or POC, trial of ALTO-203 in MDD patients with elevated levels of anhedonia.
Previous wording
We are currently evaluating ALTO-101 in a Phase 2 POC trial, which consists of a cross-over, double-blind, placebo-controlled, dose-escalating treatment and we expect to enroll approximately 70 adults with schizophrenia between the ages of 21 and 55. ALTO-101 is an investigational brain-penetrant phosphodiesterase 4, or PDE4, inhibitor that we are developing in a novel transdermal formulation for the treatment of Cognitive Impairment Associated with Schizophrenia, or CIAS. Through this unique formulation, ALTO-101 is designed to retain the desired brain effects shown with the oral formulation and avoid tolerability challenges and adverse effects known to be associated with PDE4 inhibitors. The primary endpoint in the study is the effect of ALTO-101 on theta band activity, the EEG measure shown to be best related to CIAS in replicated analyses of large schizophrenia datasets. Objective cognitive performance will also be evaluated. We expect to report topline data from this study in the second half of 2025.
Current wording
We are currently evaluating ALTO-101 in a Phase 2 POC trial, which consists of a cross-over, double-blind, placebo-controlled, dose-escalating treatment and we expect to enroll approximately 70 adults with schizophrenia between the ages of 21 and 55. ALTO-101 is an investigational brain-penetrant phosphodiesterase 4, or PDE4, inhibitor that we are developing in a novel transdermal formulation for the treatment of Cognitive Impairment Associated with Schizophrenia, or CIAS. Through this unique formulation, ALTO-101 is designed to retain the desired brain effects shown with the oral formulation and avoid tolerability challenges and adverse effects known to be associated with PDE4 inhibitors. The primary endpoint in the study is the effect of ALTO-101 on theta band activity, the EEG measure shown to be best related to CIAS in replicated analyses of large schizophrenia datasets. Objective cognitive performance will also be evaluated.
Previous wording
Since our inception in 2019, we have devoted substantially all of our resources to the research and development of our product candidates by conducting clinical trials and preclinical studies, building our Platform, and recruiting management and technical staff to support these operations. To date, we have funded our operations primarily through the aggregate net proceeds from equity financings (including from our initial public offering, or IPO, and pre-IPO sales of our convertible preferred stock) and borrowings under our loan and security agreement.
Current wording
Since our inception in 2019, we have devoted substantially all of our resources to the research and development of our product candidates by conducting clinical trials and preclinical studies, building our Platform, and recruiting management and technical staff to support these operations. To date, we have funded our operations primarily through the aggregate net proceeds from equity financings (including from our initial public offering, or IPO, the Private Placement, and pre-IPO sales of our convertible preferred stock) and borrowings under our loan and security agreement.
Previous wording
We have not generated any revenue from product sales and we have incurred recurring losses since our inception. Our net losses were $17.7 million and $32.9 million for the three and six months ended June 30, 2025, respectively. Our net losses were $16.0 million and $29.4 million for the three and six months ended June 30, 2024, respectively. As of June 30, 2025, we had an accumulated deficit of $171.3 million. We expect to continue to generate operating losses and negative operating cash flows for the foreseeable future. We anticipate that our operating expenses and capital expenditures will increase substantially with our ongoing activities, particularly as we:
Current wording
We have not generated any revenue from product sales and we have incurred recurring losses since our inception. Our net losses were $14.2 million and $47.1 million for the three and nine months ended September 30, 2025, respectively. Our net losses were $16.8 million and $46.2 million for the three and nine months ended September 30, 2024, respectively. As of September 30, 2025, we had an accumulated deficit of $185.5 million. We expect to continue to generate operating losses and negative operating cash flows for the foreseeable future. We anticipate that our operating expenses and capital expenditures will increase substantially with our ongoing activities, particularly as we:
Previous wording
As of June 30, 2025, we had cash, cash equivalents and restricted cash of$148.1 million. In February 2024, we raised net proceeds of approximately$133.0 million through our IPO. We believe that our existing cash and cash equivalents will be sufficient to fund our operating expenses and capital expenditure requirements into 2028. See “—Liquidity and Capital Resources.”
Current wording
As of September 30, 2025, we had cash, cash equivalents and restricted cash of$138.3 million, and in October 2025, we raised approximately$49.9 millionin net proceeds from the Private Placement. We believe that our existing cash and cash equivalents, including the Private Placement proceeds will be sufficient to fund our operating expenses and capital expenditure requirements into 2028, including enhanced development of ALTO-207. See “—Liquidity and Capital Resources.”
Previous wording
Research and development expenses were$13.1 million for the three months ended June 30, 2025, compared to$13.2 million for the three months ended June 30, 2024. Current period activity varied from prior year activity as follows:
Current wording
Research and development expenses were$10.5 million for the three months ended September 30, 2025, compared to$13.1 million for the three months ended September 30, 2024. Current period activity varied from prior year activity as follows:
Previous wording
•a decrease of approximately $1.7 million related to ALTO-100 primarily driven by the completion of the Phase 2b trial in MDD in the fourth quarter of 2024; and
Current wording
•a decrease of $1.6 million in clinical development related expenses primarily driven by the completion of our ALTO-100 Phase 2b trial in MDD and our ALTO-203 Phase 2 POC clinical trial; and
Previous wording
•a decrease of approximately $0.9 million related to ALTO-300 primarily driven by patient enrollment timing in the ongoing Phase 2b trial in MDD; and
Current wording
•a decrease of approximately $0.6 million in expenses related to ALTO-300 primarily driven by timing of subject visits in the ongoing Phase 2b trial in MDD; and
Previous wording
•an increase of approximately$0.7 million in salary and personnel related costs during the three months ended June 30, 2025 due to increased headcount as well as $0.2 million of severance costs and$0.1 million of non-cash stock-based compensation.
Current wording
•a decrease of $0.9 million in salary and personnel related costs during the three months ended September 30, 2025.
Previous wording
General and administrative expenses were $11.3 million for the six months ended June 30, 2025, compared to $9.6 million for the six months ended June 30, 2024. The increase of $1.7 million was primarily due to the following:
Current wording
General and administrative expenses were $4.4 million for the three months ended September 30, 2025, compared to $5.8 million for the three months ended September 30, 2024. The decrease of $1.4 million was primarily due to decreases in payroll related expenses and a decrease in professional fees.
Previous wording
Other income, net decreased $1.3 million in the three months ended June 30, 2025, compared to the three months ended June 30, 2024. The decrease was primarily due a decrease in interest income of $1.0 million and an increase in interest expense of $0.3 million.
Current wording
Other income, net decreased $1.3 million in the three months ended September 30, 2025, compared to the three months ended September 30, 2024. The decrease was primarily due to a decrease in interest income of $1.0 million and an increase in interest expense of $0.3 million.
Previous wording
The following table summarizes our results of operations for the six months ended June 30, 2025 and 2024 (in thousands):
Current wording
The following table summarizes our results of operations for the nine months ended September 30, 2025 and 2024 (in thousands):
Previous wording
Research and development expenses were $23.1 million for the six months ended June 30, 2025, compared to $23.1 million for the six months ended June 30, 2024. Current period activity varied from prior year activity as follows:
Current wording
Research and development expenses were $33.6 million for the nine months ended September 30, 2025, compared to $36.2 million for the nine months ended September 30, 2024. Current period activity varied from prior year activity as follows:
Previous wording
•a decrease of approximately $1.1 million related to ALTO-300 primarily driven by patient enrollment timing in the ongoing Phase 2b trial in MDD.
Current wording
•a decrease of approximately $1.7 million in expenses related to ALTO-300 primarily driven by timing of subject visits in the ongoing Phase 2b trial in MDD.
Previous wording
•an increase of approximately $0.7 million in salary and personnel-related costs; and
Current wording
•an increase of approximately $0.7 million in expenses related to development of our ALTO-207 program; and
Previous wording
•an increase of approximately $0.5 million related to our Phase 2 POC trial of ALTO-101, which began in 2024;
Current wording
•an increase of approximately $0.5 million in expenses related to our Phase 2 POC trial of ALTO-101, which began in 2024; and
Previous wording
Other income, net decreased $1.8 million in the six months ended June 30, 2025, compared to the six months ended June 30, 2024. The decrease was primarily due to a decrease in interest income of $0.7 million, an increase in interest expense of
Current wording
Other income, net decreased $3.1 million in the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024. The decrease was primarily due to a decrease in interest income of $1.7 million, an increase in interest expense of $0.9 million, and an increase in expense of $0.7 million related to debt extinguishment costs ($0.4 million of which was non-cash) for our Amended Term Loan.
Previous wording
We have incurred net losses and negative cash flows from operations since our inception and anticipate we will continue to incur net losses for the foreseeable future. We have not yet commercialized any of our product candidates, which are in various phases of development, and we do not expect to generate revenue from sales of any of our product candidates for several years, if at all. As we progress through the phases of development, we anticipate that we will incur increasing losses in future quarters and years compared to historical periods. To date, we have funded our operations primarily through the aggregate net proceeds from equity financings (including from our IPO and pre-IPO sales of our convertible preferred stock) and borrowings under our loan and security agreement.
Current wording
We have incurred net losses and negative cash flows from operations since our inception and anticipate we will continue to incur net losses for the foreseeable future. We have not yet commercialized any of our product candidates, which are in various phases of development, and we do not expect to generate revenue from sales of any of our product candidates for several years, if at all. As we progress through the phases of development, we anticipate that we will incur increasing losses in future quarters and years compared to historical periods. To date, we have funded our operations primarily through the aggregate net proceeds from equity financings (including from our IPO, the Private Placement, and pre-IPO sales of our convertible preferred stock) and borrowings under our loan and security agreement.
Previous wording
As of June 30, 2025 and December 31, 2024, we had cash, cash equivalents and restricted cash of $148.1 million and $168.7 million, respectively.
Current wording
As of September 30, 2025 and December 31, 2024, we had cash, cash equivalents and restricted cash of $138.3 million and $168.7 million, respectively.
Previous wording
On February 3, 2025, we filed a shelf registration statement on Form S-3 with the SEC in relation to the registration of common stock, preferred stock, debt securities, warrants and units or any combination thereof up to a total aggregate offering price of $300.0 million. We also simultaneously entered into a Sales Agreement, or the Sales Agreement, with Leerink Partners LLC, or the Sales Agent, pursuant to which we may issue and sell, from time to time at our discretion, shares of our common stock having an aggregate offering price of up to $75.0 million through or to the Sales Agent. No shares of common stock have been issued and sold to date pursuant to the Sales Agreement.
Current wording
On February 3, 2025, we also simultaneously entered into a Sales Agreement, or the Sales Agreement, with Leerink Partners LLC, or the Sales Agent, pursuant to which we could issue and sell, from time to time at our discretion, shares of our common stock having an aggregate offering price of up to $75.0 million through or to the Sales Agent. We terminated the Sales Agreement effective as of October 30, 2025. We had not sold any shares of common stock under the Sales Agreement prior to termination.
Previous wording
Net cash used in operating activities was$30.3 million for the six months ended June 30, 2025, as compared to$22.7 million for thesix months ended June 30, 2024. The increase in cash used was the result of: increased net losses of $3.4 million, timing of bonus payments, and a decrease in non-cash expenses in 2025 primarily related to achievement of a milestone under a developmental license agreement. The increase in cash used in operating activities was partially offset by recognition of a non-cash loss on debt extinguishment related to the Amended Loan Agreement.
Current wording
Net cash used in operating activities was$40.3 million for the nine months ended September 30, 2025, as compared to$34.4 million for thenine months ended September 30, 2024. The increase in cash used was the result of an increase in net losses of $0.8 million and a change in accrued liabilities and other liabilities of $5.7 million primarily due to the timing of bonus and payroll payments. The increase in cash used in operating activities was partially offset by recognition of a non-cash loss on debt extinguishment related to the Amended Loan Agreement.
Previous wording
The net cash used in investing activities for the six months ended June 30, 2025 was negligible.
Current wording
The net cash used in investing activities for the nine months ended September 30, 2025 was negligible.
Previous wording
Net cash used in investing activities was $0.6 million for thesix months ended June 30, 2024, for corporate and clinical trial related capital expenditures, specifically EEG machines utilized in our clinical trials.
Current wording
Net cash used in investing activities was $1.6 million for thenine months ended September 30, 2024, for corporate and clinical trial related capital expenditures, specifically EEG machines utilized in our clinical trials.
Previous wording
Net cash provided by financing activities was$9.7 million for thesix months ended June 30, 2025, primarily related to the net increase in borrowings under our Amended Loan Agreement as well as the drawdown of $0.8 million under our Convertible Grant Agreement.
Current wording
Net cash provided by financing activities was$9.9 million for thenine months ended September 30, 2025, primarily related to the net increase in borrowings under our Amended Loan Agreement, the drawdown of $0.8 million under our Convertible Grant Agreement and $0.4 million of cash provided from the exercise of stock options.
Previous wording
Net cash provided by financing activities was$134.3 million for thesix months ended June 30, 2024, primarily related to the issuance of 9,246,000 shares of common stock in our IPO at aprice to the public of $16.00 per share, offset by $3.2 million of other offering expenses paid during the six months ended June 30, 2024.
Current wording
Net cash provided by financing activities was$135.6 million for thenine months ended September 30, 2024, primarily related to the issuance of 9,246,000 shares of common stock in our IPO at aprice to the public of $16.00 per share, offset by $3.2 million of other offering expenses paid during the nine months ended September 30, 2024.
Previous wording
We believe that our existing cash and cash equivalents of $147.6 million, together with anticipated proceeds under our Convertible Grant Agreement with Wellcome Trust, will be sufficient to fund our operating expenses and capital expenditure requirements into 2028. This estimate reflects both our prioritization efforts to improve operating efficiency, including reducing headcount in May 2025 which resulted in short-term severance costs, and our re-deployment of long-term savings toward new programs such as ALTO-207 and ALTO-208. However, our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially. We have based this estimate on assumptions that may prove to be wrong, and we could expend our capital resources sooner than we currently expect.
Current wording
We believe that our existing cash and cash equivalents of $137.8 million as of September 30, 2025, together with both the net proceeds from the Private Placement and anticipated proceeds under our Convertible Grant Agreement with Wellcome Trust, will be sufficient to fund our operating expenses and capital expenditure requirements into 2028, including enhanced development of ALTO-207. This estimate reflects both our prioritization efforts to improve operating efficiency, including reducing headcount in May 2025 which resulted in short-term severance costs, and our re-deployment of long-term savings toward new programs such as ALTO-207 and ALTO-208. However, our forecast of the period of time through which our financial resources will be adequate to support our soperations is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially. We have based this estimate on assumptions that may prove to be wrong, and we could expend our capital resources sooner than we currently expect.
Previous wording
In addition to ongoing needs to fund our operations, our material cash requirements as of June 30, 2025 consist primarily of obligations under both our Amended Loan Agreement (see Note 4 to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report) and our lease commitment of $7.1 million for our headquarters office space located in Mountain View, California with an initial lease term of 65 months that terminates in March 2030. If the Company elects to terminate the lease after the third lease year, including payments already made, the Company will make payments of approximately $4.0 million over the term of the lease.
Current wording
In addition to ongoing needs to fund our operations, our material cash requirements as of September 30, 2025 consist primarily of obligations under both our Amended Loan Agreement (see Note 4 to our unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report) and our lease commitment for our headquarters office space located in Mountain View, California with an initial lease term of 65 months that terminates in March 2030 for which we currently have a $6.4 million commitment remaining. If the Company elects to terminate the lease after the third lease year, including payments already made, the Company will make payments of approximately $4.0 million over the term of the lease.
Previous wording
In May 2021, we entered into a patent and know-how license agreement, or the Cerecor Agreement, with Cerecor Inc. (n/k/a Avalo Therapeutics, Inc.), or Cerecor, pursuant to which we obtained an exclusive worldwide, royalty-bearing license, with the right to sublicense, under certain patent rights and know-how owned or controlled by Cerecor relating to an NR2B inhibitor compound now known as ALTO-202, including certain rights licensed to Cerecor by Essex Chemie AG, or Merck, to research, develop, make, have made, use, import, offer for sale and sell ALTO-202 and products incorporating ALTO-202, or Cerecor Licensed Products, for the prevention, diagnosis and/or treatment of all diseases in humans.
Current wording
(n/k/a Avalo Therapeutics, Inc.), or Cerecor, pursuant to which we obtained an exclusive worldwide, royalty-bearing license, with the right to sublicense, under certain patent rights and know-how owned or controlled by Cerecor relating to an NR2B inhibitor compound now known as ALTO-202, including certain rights licensed to Cerecor by Essex Chemie AG, or Merck, to research, develop, make, have made, use, import, offer for sale and sell ALTO-202 and products incorporating ALTO-202, or Cerecor Licensed Products, for the prevention, diagnosis and/or treatment of all diseases in humans.
Previous wording
In October 2021, we entered into an asset purchase agreement, or the Teva Agreement, with Teva Pharmaceutical Industries, Ltd. and its affiliate Cephalon, Inc., or together Teva, pursuant to which we acquired patents, know-how and other rights to ALTO-203 and a specified related compound, or Teva Acquired Compounds, and we assumed all post-acquisition liabilities related thereto. In April 2024, we achieved a clinical milestone under the Teva Agreement related to the initiation of our Phase 2 POC trial evaluating ALTO-203 and paid Teva $0.5 million in cash during thethree and six months ended June 30, 2024.
Current wording
In October 2021, we entered into an asset purchase agreement, or the Teva Agreement, with Teva Pharmaceutical Industries, Ltd. and its affiliate Cephalon, Inc., or together Teva, pursuant to which we acquired patents, know-how and other rights to ALTO-203 and a specified related compound, or Teva Acquired Compounds, and we assumed all post-acquisition liabilities related thereto. In April 2024, we achieved a clinical milestone under the Teva Agreement related to the initiation of our Phase 2 POC trial evaluating ALTO-203 and paid Teva $0.5 million in cash during thenine months ended September 30, 2024.
Previous wording
In September 2023, we entered into a joint development and license agreement, or the MedRx Agreement, with MedRx Co., Ltd., or MedRx, pursuant to which we obtained an exclusive, sublicensable, worldwide license, with the right to sublicense, under certain patent rights and know-how of MedRx relating to transdermal drug delivery to develop (excluding any pre-clinical development), manufacture, and commercialize transdermally delivered pharmaceutical products comprising MedRx’s transdermal patch technology and our ALTO-101, or MedRx Licensed Product, for all therapeutic, prophylactic, and diagnostic uses. We granted MedRx an exclusive, sublicensable, worldwide license under certain patent rights and know-how relating to ALTO-101 owned or controlled by us, including certain patents and know how licensed to us pursuant to the Sanofi Agreement, solely to conduct pre-clinical development and manufacturing of the MedRx Licensed Products for us in accordance with the MedRx Agreement and a separate manufacturing and supply agreement to be entered into between us and MedRx. In April 2024 we achieved a milestone under the MedRx Agreement and paid MedRx $0.8 million in cash and issued 46,875 shares of our common stock, recognizing expense of $1.5 million during thethree months ended June 30, 2024.
Current wording
In September 2023, we entered into a joint development and license agreement, or the MedRx Agreement, with MedRx Co., Ltd., or MedRx, pursuant to which we obtained an exclusive, sublicensable, worldwide license, with the right to sublicense, under certain patent rights and know-how of MedRx relating to transdermal drug delivery to develop (excluding any pre-clinical development), manufacture, and commercialize transdermally delivered pharmaceutical products comprising MedRx’s transdermal patch technology and our ALTO-101, or MedRx Licensed Product, for all therapeutic, prophylactic, and diagnostic uses. We granted MedRx an exclusive, sublicensable, worldwide license under certain patent rights and know-how relating to ALTO-101 owned or controlled by us, including certain patents and know how licensed to us pursuant to the Sanofi Agreement, solely to conduct pre-clinical development and manufacturing of the MedRx Licensed Products for us in accordance with the MedRx Agreement and a separate manufacturing and supply agreement to be entered into between us and MedRx. In April 2024 we achieved a milestone under the MedRx Agreement and paid MedRx $0.8 million in cash and issued 46,875 shares of our common stock, recognizing expense of $1.5 million during the nine months ended September 30, 2024.
Rearranged current paragraphs (4)
Current report — wording carried from elsewhere
•an increase of approximately $0.5 million in salary and personnel related costs.
Current report — wording carried from elsewhere
On February 3, 2025, we filed a shelf registration statement on Form S-3 with the SEC in relation to the registration of common stock, preferred stock, debt securities, warrants and units or any combination thereof up to a total aggregate offering price of $300.0 million.
Current report — wording carried from elsewhere
No shares of common stock have been issued and sold to date pursuant to the Sales Agreement.
Current report — wording carried from elsewhere
In May 2021, we entered into a patent and know-how license agreement, or the Cerecor Agreement, with Cerecor Inc.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
$0.6 million and an increase in expense of $0.7 million related to debt extinguishment costs ($0.4 million of which was non-cash) for our Amended Term Loan.