Latigo Biotherapeutics, Inc.

Previous wording

We are a clinical-stage biopharmaceutical company committed to developing innovative non-opioid pain medicines designed to rapidly and effectively stop the transmission of pain without the risk of addiction. Pain represents one of the largest and most pervasive therapeutic markets in the United States, driving an estimated 250 million prescriptions annually across acute and chronic settings; however, a continued reliance on opioids has contributed to a persistent public health crisis with significant societal and economic costs. Our two most advanced candidates, onzotrigine and LTG-321, are oral Nav 1.8 inhibitors designed to inhibit the transmission of pain. We are also advancing additional Nav 1.8 candidates that can address alternative formulation and delivery approaches. Beyond Nav 1.8, we plan to explore other ion channel targets involved in pain transmission that offer complementary mechanisms of action, enabling potential use in multi-modal treatment to enhance pain relief or address diverse pain etiologies. Pain is heterogenous and can be experienced in a chronic or acute manner, within both musculoskeletal and neuropathic pain. Our initial development efforts are focused on musculoskeletal pain, where we believe there is significant unmet need and an opportunity for differentiated clinical benefit utilizing a Nav 1.8 mechanism. We aim to build one of the broadest pipelines of pain therapeutics, which we believe, combined with our management team’s deep expertise in pain biology, clinical translation and trial execution, positions us to deliver meaningful patient benefit and to change the current treatment paradigm of pain medicines.

Current wording

We are a clinical-stage biopharmaceutical company committed to developing innovative non-opioid pain medicines designed to rapidly and effectively stop the transmission of pain without the risk of addiction. Pain represents one of the largest and most pervasive therapeutic markets in the United States, driving an estimated 250 million prescriptions annually across acute and chronic settings; however, a continued reliance on opioids has contributed to a persistent public health crisis with significant societal and economic costs. Our two most advanced candidates, onzotrigine and LTG-321, are oral Nav 1.8 inhibitors designed to inhibit the transmission of pain. We are also advancing additional Nav 1.8 candidates that can address alternative formulation and delivery approaches. Beyond Nav 1.8, we plan to explore other ion channel targets involved in pain transmission that offer complementary mechanisms of action, enabling potential use in multi-modal treatment to enhance pain relief or address diverse pain etiologies. Pain is heterogeneous and can be experienced in a chronic or acute manner, within both musculoskeletal and neuropathic pain. Our initial development efforts are focused on musculoskeletal pain, where we believe there is significant unmet need and an opportunity for differentiated clinical benefit utilizing a Nav 1.8 mechanism. We aim to build one of the broadest pipelines of pain therapeutics, which we believe, combined with our management team’s deep expertise in pain biology, clinical translation and trial execution, positions us to deliver meaningful patient benefit and to change the current treatment paradigm of pain medicines.

Previous wording

Met primary endpoint and achieved ~50% greater analgesic effect than opioid comparator: High dose onzotrigine (450mg loading followed by 300mg every 12 hours) met its primary endpoint of Summed Pain Intensity Difference from 0 to 48 hours (SPID48) versus placebo, achieving a 62.1-point (p<0.001) improvement versus placebo and exceeding hydrocodone bitrate/acetaminophen (HB/APAP), which is commonly known as Vicodin, the opioid comparator’s SPID48 of 40.9 (p=0.001).

Current wording

Met primary endpoint and achieved ~50% greater analgesic effect than opioid comparator: High dose onzotrigine (450mg loading followed by 300mg every 12 hours) met its primary endpoint of Summed Pain Intensity Difference from 0 to 48 hours (SPID48) versus placebo, achieving a 62.1-point (p<0.001) improvement versus placebo and exceeding hydrocodone bitartrate/acetaminophen (HB/APAP), which is commonly known as Vicodin, the opioid comparator’s SPID48 of 40.9 (p=0.001).

Previous wording

We plan to initiate a placebo-controlled Phase 3 trial in participants undergoing bunionectomy and an open-label Phase 3 safety trial exploring onzotrigine within a broader population of patients with moderate to severe acute pain across a variety of post-surgical and non-surgical settings in the second half of 2026, with topline results expected in the second half of 2027. In addition to oral dosing, onzotrigine is also being advanced as a potential intravenous (IV) formulation to support use in hospital settings and enable transition from inpatient postoperative care to outpatient pain management.

Current wording

We plan to initiate a placebo-controlled Phase 3 trial in participants undergoing bunionectomy and an open-label Phase 3 safety trial exploring onzotrigine within a broader population of patients with moderate to severe acute pain across a variety of post-surgical and non-surgical settings with topline results expected in the second half of 2027.

Previous wording

We are also in discovery of additional ion channel modulators involved in peripheral transmission of pain that represent potential complementary mechanisms of action to Nav 1.8 inhibition for additional pain relief including in other pain etiologies like neuropathic pain.

Current wording

We are also conducting discovery research on additional ion channel modulators involved in peripheral transmission of pain that represent potential complementary mechanisms of action to Nav 1.8 inhibition for additional pain relief including in other pain etiologies like neuropathic pain.

Previous wording

We have incurred significant operating losses and negative cash flows since our inception, consistent with our operating plan. Our net losses were $48.8 million and $46.8 million for the six months ended June 30, 2026 and 2025, respectively. As of June 30, 2026, we had an accumulated deficit of $291.9 million and cash and cash equivalents of $55.0 million.

Current wording

We have incurred significant operating losses and negative cash flows since our inception, consistent with our operating plan. Our net losses were $69.7 million and $71.6 million for the nine months ended September 30, 2026 and 2025, respectively. As of September 30, 2026, we had an accumulated deficit of $312.8 million and cash and cash equivalents of $401.2 million.

Previous wording

Since our inception, we have financed our operations primarily through the sale of shares of our redeemable convertible preferred stock and convertible notes. In June 2026, the Company issued unsecured convertible promissory notes (the Convertible Notes) to various holders in the aggregate principal amount of $35.0 million. Additionally, in August 2026, we closed our initial public offering (IPO) pursuant to which we issued and sold 22,080,000 shares of our common stock at a public offering price of $18.00 per share (IPO Price), including 2,880,000 additional shares of our common stock pursuant to the exercise in full by the underwriters of their option to purchase shares of common stock from us at the IPO Price. As a result, we received net proceeds of approximately $363.9 million, after deducting underwriting discounts, commissions and other offering expenses payable by us of approximately $33.6 million. Immediately prior to the closing of our IPO, the Convertible Notes automatically converted into 1,957,755 shares of common stock. Based on our current operating plans, we estimate that our cash and cash equivalents, together with our net IPO proceeds, will be sufficient to fund our projected operating expenses and capital expenditure requirements into 2029.

Current wording

Since our inception, we have financed our operations primarily through the sale of shares of our redeemable convertible preferred stock and convertible notes. In June 2026, the Company issued unsecured convertible promissory notes (the Convertible Notes) to various holders in the aggregate principal amount of $35.0 million. Additionally, in August 2026, we closed our initial public offering (IPO) pursuant to which we issued and sold 22,080,000 shares of our common stock at a public offering price of $18.00 per share (IPO Price), including 2,880,000 additional shares of our common stock pursuant to the exercise in full by the underwriters of their option to purchase shares of common stock from us at the IPO Price. As a result, we received net proceeds of approximately $364.4 million, after deducting underwriting discounts, commissions and other offering expenses of approximately $33.1 million. Immediately prior to the closing of our IPO, the Convertible Notes automatically converted into 1,957,755 shares of common stock. Based on our current operating plans, we estimate that our cash and cash equivalents will be sufficient to fund our projected operating expenses and capital expenditure requirements into 2029.

Previous wording

We have based this estimate on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we expect. Our existing cash and cash equivalents, plus our net IPO proceeds, will not be sufficient for us to fund our product candidates through clinical trials, regulatory approval and commercialization, and we will need to raise substantial additional capital in order to do so. We plan to monitor expenses and may raise additional capital opportunistically through the sale of public or private equity, debt financings or other capital sources, which may include our existing and any future licensing or collaboration arrangements, strategic collaborations and other strategic arrangements with third parties. Our ability to access capital when needed is not assured, and if capital is not available to us when, and in the amounts, needed, and on acceptable terms, we may need to delay, scale back or abandon some or all of our development programs and other operations, which could materially affect our business, financial condition, and results of operations.

Current wording

We have based this estimate on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we expect. Our existing cash and cash equivalents will not be sufficient for us to fund our product candidates through clinical trials, regulatory approval and commercialization, and we will need to raise substantial additional capital in order to do so. We plan to monitor expenses and may raise additional capital opportunistically through the sale of public or private equity, debt financings or other capital sources, which may include our existing and any future licensing or collaboration arrangements, strategic collaborations and other strategic arrangements with third parties. Our ability to access capital when needed is not assured, and if capital is not available to us when, and in the amounts, needed, and on acceptable terms, we may need to delay, scale back or abandon some or all of our development programs and other operations, which could materially affect our business, financial condition, and results of operations.

Previous wording

Interest income (expense), net primarily consists of interest earned on our cash and cash equivalents and convertible notes interest expense. We expect interest income to vary each reporting period depending on our average money market fund balance during the period and market interest rates.

Current wording

Other (income) expense, net consists of interest earned on our cash and cash equivalents. Interest expense consists of contractual interest and the amortization of debt discount and issuance costs on the Convertible Notes issued in June 2026, which converted into common stock in connection with our IPO in August 2026. We expect interest income to vary each reporting period depending on our average money market fund balance during the period and market interest rates.

Previous wording

Comparison of the three and six months ended June 30, 2026 and 2025

Current wording

Comparison of the three and nine months ended September 30, 2026 and 2025

Previous wording

Research and development expenses were $21.2 million for the three months ended June 30, 2026 compared to $22.9 million for the three months ended June 30, 2025. The net decrease of $1.7 million was primarily due to a $1.4 million decrease in direct costs related to clinical and non-clinical development of onzotrigine and $2.0 million decrease in direct program costs for other clinical programs, offset by an increase of $1.4 million in personnel-related expenses due to increased headcount to support our development activities, including stock-based compensation, and an increase of $0.3 million in other R&D expenses.

Current wording

Research and development expenses were $17.5 million for the three months ended September 30, 2026 compared to $22.1 million for the three months ended September 30, 2025. The net decrease of $4.6 million was primarily due to a $6.2 million decrease in direct costs related to clinical and non-clinical development of onzotrigine and a $0.3 million decrease in other R&D expenses, partially offset by a $1.8 million increase in personnel-related expenses due to increased headcount to support our development activities, including stock-based compensation. Direct program costs for other clinical programs were flat compared to the prior-year period.

Previous wording

The $1.9 million decrease in direct costs related to clinical and non-clinical development of onzotrigine was primarily due to a $1.5 million decrease in clinical manufacturing related expenses and $1.2 million decrease in expenses for clinical trials, offset by a $0.6 million increase in discovery and non-clinical related activities for onzotrigine, and a $0.2 million increase in general R&D related expenses for onzotrigine.

Current wording

The $6.2 million net decrease in direct costs related to clinical and non-clinical development of onzotrigine was primarily due to a $6.7 million decrease in expenses for clinical trials and a $0.3 million decrease in clinical manufacturing related expenses, offset by a $0.8 million increase in discovery and non-clinical related activities for onzotrigine and a $0.1 million increase in general R&D related expenses for onzotrigine.

Previous wording

The $2.0 million decrease related to other clinical programs was mainly comprised of a $2.4 million decrease in clinical trial expenses, a $0.2 million decrease in clinical manufacturing expenses, a $0.1 million decrease in general research and development expenses, offset by a $0.7 million increase in discovery and non-clinical expenses.

Current wording

Direct program costs for other clinical programs were $5.1 million for each of the three months ended September 30, 2026 and 2025. A $1.1 million increase in discovery and non-clinical expenses and a $0.1 million increase in clinical trial expenses were partially offset by a $1.0 million decrease in clinical manufacturing expenses and a $0.1 million decrease in general research and development expenses.

Previous wording

The $0.7 million increase in discovery and non-clinical expenses for other clinical programs was mainly driven by a $0.7 million increase related to LTG-321, our next generation candidate for the inhibition of Nav 1.8 and an increase of $1.1 million related to next generation Nav 1.8 inhibitor molecules due to timing of such research activities, offset by a decrease of $1.1 million related to a clinical program which has since been terminated.

Current wording

The $1.1 million net increase in discovery and non-clinical expenses for other clinical programs was mainly driven by a $0.8 million increase related to LTG-321, our next-generation candidate for the inhibition of Nav1.8, a $0.4 million increase related to next generation Nav1.8 inhibitor molecules due to timing of such research activities and a $0.2 million increase related to LTG-418, partially offset by a $0.3 million decrease related to a clinical program which has since been terminated.

Previous wording

Research and development expenses were $38.9 million for the six months ended June 30, 2026 compared to $41.6 million for the six months ended June 30, 2025. The net decrease of $2.7 million was primarily due to a decrease of $1.9 million of direct costs related to clinical and non-clinical development of onzotrigine and a $4.3 million decrease in direct program costs for other clinical programs, offset by an increase of $2.8 million in personnel-related expenses due to increased headcount to support our development activities, including stock-based compensation, and an increase of $0.6 million in other R&D expenses.

Current wording

Research and development expenses were $56.4 million for the nine months ended September 30, 2026 compared to $63.7 million for the nine months ended September 30, 2025. The net decrease of $7.3 million was primarily due to a decrease of $8.0 million of direct costs related to clinical and non-clinical development of onzotrigine and a $4.3 million decrease in direct program costs for other clinical programs, offset by an increase of $4.6 million in personnel-related expenses due to increased headcount to support our development activities, including stock-based compensation, and an increase of $0.4 million in other R&D expenses.

Previous wording

The $1.4 million decrease in direct costs related to clinical and non-clinical development of onzotrigine was primarily due to a $2.5 million decrease in expenses for clinical trials, offset by an increase of $0.3 million in clinical manufacturing related expenses, an increase of $0.7 million in discovery and non-clinical related activities for onzotrigine, and a $0.1 million increase in general R&D related expenses for onzotrigine.

Current wording

The $8.0 million net decrease in direct costs related to clinical and non-clinical development of onzotrigine was primarily due to a $7.9 million decrease in expenses for clinical trials and a $1.8 million decrease in clinical manufacturing related expenses, offset by a $1.3 million increase in discovery and non-clinical related activities for onzotrigine and a $0.4 million increase in general R&D related expenses for onzotrigine.

Previous wording

The $4.3 million decrease related to other clinical programs was mainly comprised of a $2.5 million decrease in clinical trial expenses, a $0.6 million decrease in clinical manufacturing expenses, a $0.5 million decrease in general research and development expenses and a $0.7 million decrease in discovery and non-clinical expenses.

Current wording

The $4.3 million net decrease related to other clinical programs was mainly comprised of a $2.5 million decrease in clinical trial expenses, a $1.7 million decrease in clinical manufacturing expenses and a $0.6 million decrease in general research and development expenses, offset by a $0.5 million increase in discovery and non-clinical expenses.

Previous wording

The $0.7 million decrease in discovery and non-clinical expenses for other clinical programs was mainly driven by a $2.1 million decrease related to a clinical program which has since been terminated, a $0.2 million decrease related to LTG-321, our next generation candidate for the inhibition of Nav 1.8, offset by a $1.7 million increase related to next generation Nav 1.8 inhibitor molecules due to timing of such research activities.

Current wording

The $0.5 million net increase in discovery and non-clinical expenses for other clinical programs was mainly driven by a $2.1 million increase related to next generation Nav1.8 inhibitor molecules due to timing of such research activities, a $0.6 million increase related to LTG-321, our next generation candidate for the inhibition of Nav1.8, and a $0.2 million increase related to LTG-418, offset by a $2.4 million net decrease related to a clinical program which has since been terminated.

Previous wording

The $2.5 million decrease in clinical expenses for other clinical programs was driven by a $3.6 million decrease related to a clinical program which has since been terminated, offset by a $1.1 million increase in clinical trial expenses related to LTG-321, our next generation candidate for the inhibition of Nav 1.8.

Current wording

The $2.5 million net decrease in clinical expenses for other clinical programs was driven by a $4.1 million decrease related to a clinical program which has since been terminated, offset by a $1.7 million increase in clinical trial expenses related to LTG-321.

Previous wording

The $0.6 million increase in other R&D expenses is primarily driven by a $0.2 million increase in IT and facility expense, $0.1 million increase in travel and entertainment expenses, $0.1 million increase in R&D related software and subscription expenses, $0.1 million increase in shipping expense and other immaterial research and development costs.

Current wording

The $0.4 million net increase in other R&D expenses was primarily driven by a $0.8 million increase in IT, facilities, office and other expenses, including a $0.3 million increase in IT and facility allocations, a $0.2 million increase in travel and entertainment expenses, a $0.2 million increase in shipping expense and a $0.1 million increase in R&D related software and subscription expenses, partially offset by a $0.3 million decrease in consulting and professional fees.

Previous wording

General and administrative expenses were $4.6 million for the three months ended June 30, 2026, compared to $2.8 million for the three months ended June 30, 2025. The $1.8 million increase was primarily attributable to a $0.8 million increase in personnel-related costs, including stock-based compensation, a $0.6 million increase in legal and professional fees, a $0.2 million increase in consulting and external contractor-related expenses and a $0.2 million increase in IT and facilities-related expenses.

Current wording

General and administrative expenses were $5.4 million for the three months ended September 30, 2026, compared to $2.6 million for the three months ended September 30, 2025. The $2.8 million increase was primarily attributable to a $0.7 million increase in personnel-related costs, including stock-based compensation, a $0.9 million increase in legal and professional fees, a $0.6 million increase in consulting and external contractor-related expenses and a $0.6 million increase in IT and facilities-related expenses.

Previous wording

General and administrative expenses were $10.4 million for the six months ended June 30, 2026, compared to $5.6 million for the six months ended June 30, 2025. The $4.7 million increase was primarily attributable to a $1.8 million increase in personnel-related costs, including stock-based compensation, a $1.3 million increase in legal and professional fees, a $1.0 million increase in IT and facilities-related expenses and a $0.6 million increase in consulting and external contractor-related expenses.

Current wording

General and administrative expenses were $15.8 million for the nine months ended September 30, 2026, compared to $8.3 million for the nine months ended September 30, 2025. The $7.5 million increase was primarily attributable to a $2.6 million increase in personnel-related costs, including stock-based compensation, a $2.2 million increase in legal and professional fees, a $1.6 million increase in IT and facilities-related expenses and a $1.2 million increase in consulting and external contractor-related expenses.

Previous wording

Since our inception, we have primarily funded our operations through the sale of shares of our redeemable convertible preferred stock and convertible notes. We have not generated any revenue from product sales and have incurred significant annual operating losses and negative cash flows from our operations. In June 2026, we raised $35.0 million in gross proceeds from the sale of Convertible Notes. In addition, in August 2026, we closed our IPO, through which we received net proceeds of approximately $363.9 million. Based on our current operating plans, we estimate that our cash and cash equivalents, together with our net IPO proceeds, will be sufficient to fund our projected operating expenses and capital expenditure requirements into 2029. Our total future capital requirements will depend on many factors and is subject to the risks and uncertainties set forth in the section titled “Risk Factors.”

Current wording

Since our inception, we have primarily funded our operations through the sale of shares of our redeemable convertible preferred stock and convertible notes. We have not generated any revenue from product sales and have incurred significant annual operating losses and negative cash flows from our operations. In June 2026, we raised $35.0 million in gross proceeds from the sale of Convertible Notes. In addition, in August 2026, we closed our IPO, through which we received net proceeds of approximately $364.4 million. As of September 30, 2026, we had cash and cash equivalents of $401.2 million. Based on our current operating plans, we estimate that our cash and cash equivalents will be sufficient to fund our projected operating expenses and capital expenditure requirements into 2029. Our total future capital requirements will depend on many factors and are subject to the risks and uncertainties set forth in the section titled “Risk Factors.”

Previous wording

Cash used in operating activities for the six months ended June 30, 2025, was mainly comprised of our net loss of $46.8 million, and $0.2 million change in net operating assets and liabilities, offset by non-cash charges of $4.3 million. The non-cash charges were primarily related to stock-based compensation expense, and depreciation and amortization.

Current wording

Cash used in operating activities for the nine months ended September 30, 2026, was mainly comprised of our net loss of $69.7 million, and the change in net operating assets and liabilities of $5.8 million, offset by non-cash charges of $7.7 million. The non-cash charges were primarily related to stock-based compensation expense, change in fair value of derivative liability and loss on extinguishment of debt.

Previous wording

Cash used in operating activities for the six months ended June 30, 2026, was mainly comprised of our net loss of $48.8 million, and the change in net operating assets and liabilities of $4.4 million, offset by non-cash charges of $4.8 million. The non-cash charges were primarily related to stock-based compensation expense and depreciation and amortization.

Current wording

Cash used in operating activities for the nine months ended September 30, 2025, was mainly comprised of our net loss of $71.6 million, offset by a $1.8 million change in net operating assets and liabilities and non-cash charges of $7.2 million. The non-cash charges were primarily related to stock-based compensation expense and change in fair value of preferred stock tranche liability.

Previous wording

Cash used in investing activities during the six months ended June 30, 2026 and 2025, reflects our investment in property and equipment during the period.

Current wording

Cash used in investing activities during the nine months ended September 30, 2026 and 2025, reflects our investment in property and equipment during the period.

Previous wording

Cash provided by financing activities during the six months ended June 30, 2026, was comprised of $35.0 million of proceeds from issuance of convertible promissory notes and $0.2 million of proceeds from issuance of common stock upon exercise of stock options, offset by $1.3 million in payments for deferred IPO costs.

Current wording

Cash provided by financing activities during the nine months ended September 30, 2026, was comprised of $364.4 million in net proceeds from our IPO, $34.8 million of proceeds from issuance of convertible promissory notes and $0.5 million of proceeds from issuance of common stock upon exercise of stock options.

Previous wording

Cash provided by financing activities during the six months ended June 30, 2025, was comprised of $99.4 million in net proceeds from issuance of Series B redeemable convertible preferred stock, net of issuance costs.

Current wording

Cash provided by financing activities during the nine months ended September 30, 2025, was comprised of $149.4 million in net proceeds from issuance of Series B redeemable convertible preferred stock, net of issuance costs.

Previous wording

In addition, we have entered into contracts in the normal course of business with CROs, contract manufacturing organizations (CMOs) and other third parties for preclinical research studies and testing, clinical trials and manufacturing services. These contracts do not contain any minimum purchase commitments and are cancelable by us upon prior notice. Payments due upon cancellation consist only of payments for services provided and expenses incurred, including non-cancelable obligations of our service providers, up to the date of cancellation. We have entered into agreements with certain vendors for the provision of goods and services, which includes manufacturing services with CMOs and development services with CROs. These agreements may include certain provisions for purchase obligations and termination obligations that could require payments for the cancellation of committed purchase obligations or for early termination of the agreements. The amount of the cancellation or termination payments vary and are based on the timing of the cancellation or termination and the specific terms of the agreement.

Current wording

In addition, we have entered into contracts in the normal course of business with CROs, contract manufacturing organizations (CMOs) and other third parties for preclinical research studies and testing, clinical trials and manufacturing services. These contracts do not contain any minimum purchase commitments and are cancelable by us upon prior notice. Cancellation payments may include amounts for services performed, expenses incurred, non-cancelable commitments and applicable termination fees. We have entered into agreements with certain vendors for the provision of goods and services, which includes manufacturing services with CMOs and development services with CROs. These agreements may include certain provisions for purchase obligations and termination obligations that could require payments for the cancellation of committed purchase obligations or for early termination of the agreements. The amount of the cancellation or termination payments varies and are based on the timing of the cancellation or termination and the specific terms of the agreement.