NeuroBo Pharmaceuticals Inc

Previous wording

We are a clinical-stage biotechnology company focused primarily ondeveloping and commercializing novel pharmaceuticals to treat cardiometabolic diseases. NeuroBo has two programs currently focused on treatment of metabolic dysfunction-associated steatohepatitis (“MASH”) and obesity. MASH was formerly known as non-alcoholic steatohepatitis (“NASH”). The American Association for the Study of Liver Diseases and its European and Latin American counterparts changed the name to metabolic dysfunction-associated steatohepatitis to reflect the complexity of the disease.

Current wording

We are a clinical-stage biotechnology company focused primarily ondeveloping and commercializing novel pharmaceuticals to treat cardiometabolic diseases. We have two programs currently focused on treatment of metabolic dysfunction-associated steatohepatitis (“MASH”) and obesity. MASH was formerly known as non-alcoholic steatohepatitis. The American Association for the Study of Liver Diseases and its European and Latin American counterparts changed the name to metabolic dysfunction-associated steatohepatitis to reflect the complexity of the disease.

Previous wording

Our operations have consisted principally of performing research and development (“R&D”) activities, clinical development and raising capital. Our activities are subject to significant risks and uncertainties, such as failing to secure additional funding before sustainable revenues and profit from operations are achieved. For more information on our business and product candidates, see “Part I, Item 1. Business” in our 2023 Form 10-K.

Current wording

Our operations have consisted principally of performing research and development (“R&D”) activities, which includes preclinical developments and clinical trials, and raising capital. Our activities are subject to significant risks and uncertainties, such as failing to secure additional funding before sustainable revenues and profit from operations are achieved. For more information on our business and product candidates, see “Part I, Item 1. Business” in our 2023 Form 10-K.

Previous wording

We are currently conducting a Phase 2a trial of DA-1241 for the treatment of MASH in the U.S. The Phase 2a trial has two parts and each of the parts is designed to be a 16-week, multicenter, randomized, double-blind, placebo-controlled, parallel clinical study to evaluate the efficacy and safety of DA-1241 in subjects with presumed MASH while we follow the trend for type 2 diabetes mellitus. Part 2 of the Phase 2a trial will also explore the efficacy of DA-1241 in combination with sitagliptin versus placebo. The Phase 2a trial opened enrollment in August 2023 and is expected to enroll a total of 87 subjects, with a planned maximum of 98 subjects to account for early discontinuations, who will be randomized into 4 treatment groups and will be dosed with: DA-1241 50 mg, DA-1241 100 mg, DA-1241 100 mg/Sitagliptin 100 mg, or Placebo in a 1:2:2:2 ratio.

Current wording

We are currently conducting a Phase 2a trial of DA-1241 for the treatment of MASH in the United States. The Phase 2a trial has two parts and each of the parts is designed to be a 16-week, multicenter, randomized, double-blind, placebo-controlled, parallel clinical study to evaluate the efficacy and safety of DA-1241 in subjects with presumed MASH while we follow the trend for type 2 diabetes mellitus. Part 2 of the Phase 2a trial will also explore the efficacy of DA-1241 in combination with sitagliptin versus placebo. Phase 2a trial enrollment began in August 2023 and we have completed enrollment of Part 1 of the Phase 2a trial in which patients with presumed MASH were randomized with a 1:2:1 ratio into 3 treatment groups: DA-1241 50 mg, DA-1241 100 mg, or placebo. Additionally, we also completed enrollment of Part 2

Previous wording

In April 2024, we completed enrollment of Part 1 of the Phase 2a trial in which approximately 49 patients with presumed MASH were randomized into Part 1 with a 1:2:1 ratio into 3 treatment groups: DA-1241 50 mg, DA-1241 100 mg, or placebo. Part 2 of the Phase 2a trial is currently enrolling and is expected to enroll approximately 37 subjects who will be randomized in a 2:1 ratio into 2 treatment groups: DA-1241 100 mg/sitagliptin 100 mg or placebo. Currently, we are expecting to report the full trial data in the second half of this year.

Current wording

of the Phase 2a trial in which patients with presumed MASH were randomized with a 2:1 ratio into 2 treatment groups: DA-1241 100 mg/sitagliptin 100 mg or placebo. Currently, we are expecting to have top line result in the fourth quarter of 2024.

Previous wording

We are currently conducting a Phase 1 trial of DA-1726 for the treatment of obesity in the U.S. The Phase 1 trial is designed to be a randomized, placebo-controlled, double-blind, two-part study to investigate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple ascending doses of DA-1726 in obese, otherwise healthy subjects. Part 1 of the Phase 1 trial opened is a single ascending dose (“SAD “) study and is expected to enroll approximately 45 participants, randomized into one of 5 planned cohorts. Each cohort will be randomized in a 6:3 ratio of DA-1726 or placebo. Part 2 of Phase 1 is designed as a multiple ascending dose (“MAD “) study and is expected to enroll approximately 36 participants, who will be randomized at the same 6:3 ratio into 4 planned cohorts, each to receive 4 weekly administrations of DA-1726 or placebo.

Current wording

We are currently conducting a Phase 1 trial of DA-1726 for the treatment of obesity in the United States. The Phase 1 trial is a randomized, placebo-controlled, double-blind, two-part study to investigate the safety, tolerability, pharmacokinetics (“PK”), and pharmacodynamics (“PD”) of single and multiple ascending doses of DA-1726 in obese, otherwise healthy subjects. Part 1 of the Phase 1 trial is a single ascending dose (“SAD”) study and enrollment began in March 2024. In August 2024, we completed enrollment with a total of 45 participants, randomized into one of five cohorts, with each cohort having been randomized in a 6:3 ratio of DA-1726 to placebo. Part 2 of Phase 1 is a multiple ascending dose (“MAD”) study, enrollment began in June 2024, and is expected to enroll approximately 36 participants, who will be randomized at the same 6:3 ratio into four planned cohorts, each to receive four weekly administrations of DA-1726 or placebo. Currently, we are expecting to report top-line data from the SAD Part 1 study in the third quarter of 2024 and the MAD Part 2 study in the first quarter of 2025.

Previous wording

Except for the financial amounts for the presented periods in this Report (see financial amounts in the below results of operations and the condensed consolidated balance sheets included elsewhere in this Report), there have been no material

Current wording

Except for the financial amounts for the presented periods in this Report (see financial amounts in the below results of operations and the condensed consolidated balance sheets included elsewhere in this Report), there have been no material changes to our key operating information since December 31, 2023. Refer to our 2023 Form 10-K for a complete discussion of our key operating information.

Previous wording

Our total operating expenses and loss from operations for the three months ended March 31, 2024 were $6.9 million, an increase of $4.4 million, or 173.1%, compared to the three months ended March 31, 2023. This increase was attributable to (i) $4.3 million in higher R&D expenses and (ii) $0.1 million in higher general and administrative expenses.

Current wording

Our total operating expenses and loss from operations for the three months ended June 30, 2024 were $10.0 million, an increase of $6.3 million, or 165.0%, compared to the three months ended June 30, 2023. This increase was attributable to $5.7 million in higher R&D expenses and $0.6 million in higher general and administrative expenses.

Previous wording

Our general and administrative expenses for the three months ended March 31, 2024 were $2.0 million, an increase of $0.1 million, or 5.0%, compared to the three months ended March 31, 2023. This increase in general and administrative expenses was primarily attributable to $0.2 million in higher non-cash stock-based compensation, partially offset by $0.1 million in lower legal and professional fees.

Current wording

Our general and administrative expenses for the three months ended June 30, 2024 were $2.0 million, an increase of $0.6 million, or 39.4%, compared to the three months ended June 30, 2023. This increase was primarily attributable to $0.4 million in higher employee compensation and benefits and $0.1 million in higher non-cash stock-based compensation.

Previous wording

Our other income for thethree months ended March 31, 2024 was $0.2 million compared to other expense of $0.1 million for thethree months ended March 31, 2023. This change was mainly attributable to $0.2 million of interest income earned on our cash balance for thethree months ended March 31, 2024, of which there was none for thethree months ended

Current wording

Our other income for thethree months ended June 30, 2024 was $31 thousand, a decrease of $3.0 million, or 99.0%, compared to thethree months ended June 30, 2023. This decrease was attributable to the recording of a loss of $0.1 million related to thechange in fair value of warrant liabilities for the three months ended June 30, 2024 compared to a gain of$3.1 million for three months ended June 30, 2023, partially offset by$0.2 million of interest income earned on our cash balance for thethree months ended June 30, 2024, of which there was none for thethree months ended June 30, 2023.

Previous wording

For the three months ended March 31, 2024, we had a netloss of $6.7 million, or$1.32 per share of basic and diluted common stock, compared to a net loss of $2.6 million, or $0.51 per share of basic and diluted common stock for the three months ended March 31, 2023.

Current wording

For the three months ended June 30, 2024, we had a netloss of $10.1 million, or$1.85 per share of basic and diluted common stock, compared to a net loss of $0.7 million, or $0.15 per share of basic and diluted common stock for the three months ended June 30, 2023.

Previous wording

Our R&D expenses were $4.9 million for the three months ended March 31, 2024, an increase of $4.3 million, or 669.9%, compared to the three months ended March 31, 2023. This increase was primarily related to increased R&D activities for DA-1241 and DA-1726 for the three months ended March 31, 2024 following commencement of the (i) Phase 2a clinical trial for DA-1241 and (ii) Phase 1 trial for DA-1726 compared to the three months ended March 31, 2023 when R&D activities were starting to ramp up following the acquisition of DA-1241 and DA-1726 in the fourth quarter of 2022. Specifically, the $4.3 million increase in R&D expenses was primarily attributable to (i) $3.9 million in higher expenditures for investigational drug manufacturing costs, non-clinical and preclinical services, clinical trials and consulting and (ii) $0.4 million in higher employee compensation and benefits. Included in R&D expenses for the three months ended March 31, 2024 was $0.2 million of investigational drug manufacturing costs and non-clinical and preclinical expenses incurred under the Shared Services Agreement with Dong-A as compared to $0.3 million for the three months ended March 31, 2023.

Current wording

Our R&D expenses were $13.0 million for the six months ended June 30, 2024, an increase of $10.0 million, or 332.5%, compared to the six months ended June 30, 2023. This increase was primarily related to increased R&D activities for DA-1241 and DA-1726 for the six months ended June 30, 2024 following commencement of the Phase 2a clinical trial for DA-1241 and Phase 1 trial for DA-1726 compared to the six months ended June 30, 2023 when R&D activities were starting to ramp up following the acquisition of DA-1241 and DA-1726 in the fourth quarter of 2022. Specifically, the $10.0 million increase in R&D expenses was primarily attributable to (i) $9.3 million in higher expenditures for investigational drug manufacturing costs, non-clinical and preclinical services, clinical trials and consulting and (ii) $0.7 million in higher employee compensation and benefits. Included in R&D expenses for the six months ended June 30, 2024 was $3.6 million of investigational drug manufacturing costs and non-clinical and preclinical expenses incurred under the Shared Services Agreement with Dong-A as compared to $1.8 million for the six months ended June 30, 2023.

Previous wording

The determination as to whether we can continue as a going concern contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. Our condensed consolidated financial statements, included elsewhere in this Report, have been prepared assuming that we will continue as a going concern and do not include any adjustments that might result from the outcome of this uncertainty. This basis of accounting contemplates the recovery of our assets and the satisfaction of our liabilities in the normal course of business.

Current wording

The determination as to whether we can continue as a going concern contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. Our condensed consolidated financial statements have been prepared assuming that we will continue as a going concern and do not include any adjustments that might result from the outcome of this uncertainty. This basis of accounting contemplates the recovery of our assets and the satisfaction of our liabilities in the normal course of business.

Previous wording

As reflected in the condensed consolidated financial statements, we had $16.0 million in cash as of March 31, 2024. We have experienced net losses and negative cash flows from operating activities since our inception and had an accumulated deficit of $115.0 million as of March 31, 2024. We have incurred a net loss of $6.7 million and used cash of $6.4 million for operating activities for the three months ended March 31, 2024. Due in large part to the ongoing Phase 2a clinical trial for DA-1241 and Phase 1 clinical trial for DA-1726, we expect to continue to incur net losses and negative cash flows from operating activities for the foreseeable future. These conditions raise substantial doubt about our ability to continue as a going concern.

Current wording

As reflected in the condensed consolidated financial statements, we had $27.9 million in cash as of June 30, 2024. We have experienced net losses and negative cash flows from operating activities since our inception and had an accumulated deficit of $125.0 million as of June 30, 2024. We have incurred a net loss of $16.8 million and net cash used of $13.7 million for operating activities for the six months ended June 30, 2024. Due in large part to the ongoing Phase 2a clinical trial for DA-1241 and Phase 1 clinical trial for DA-1726, we expect to continue to incur net losses and negative cash flows from operating activities for the foreseeable future. These conditions raise substantial doubt about our ability to continue as a going concern.

Previous wording

We believe that our existing cash will be sufficient to fund our operations into the fourth quarter of 2024. We plan to continue to fund our operations through a combination of equity offerings, debt financings, or other sources, potentially including collaborations, out-licensing and other similar arrangements. There can be no assurance that we will be able to obtain any sources of financing on acceptable terms, or at all. To the extent that we can raise additional funds by issuing equity securities, our stockholders may experience significant dilution. Any debt financing, if available, may involve restrictive covenants that impact our ability to conduct our business. If we are unable to raise additional capital, we may slow down or stop our ongoing and planned clinical trials until such time as additional capital is raised and this may have a material adverse effect on us.

Current wording

We believe that our existing cash will be sufficient to fund our operations into the second quarter of 2025. Our existing cash includes gross proceeds of $20.0 million, of which $10.0 million was received from Dong-A, in connection with the closing of the Offering (as defined below) in June 2024. We plan to continue to fund our operations through a combination of proceeds of (i) up to $20.0 million from the potential future exercise of Series A Warrants issued in the Offering (as defined below) before deducting for certain issuance costs, such as placement agent fees and expenses and (ii) from equity offerings, debt financings, or other sources, potentially including collaborations, out-licensing and other similar arrangements. If the Series A Warrants issued in the June 2024 Offering are exercised, we believe that the additional gross proceeds to us from such exercises would be sufficient to fund our operations into 2026. There can be no assurance that we will be able to obtain any sources of financing on acceptable terms, or at all, or that the Series A Warrants will be exercised. To the extent that we can raise additional funds by issuing equity securities or in the event our existing warrants are exercised, our stockholders may experience significant dilution. Any debt financing, if available, may involve restrictive covenants that impact our ability to conduct our business. If we are unable to raise additional capital, we may slow down or stop our ongoing and planned clinical trials until such time as additional capital is raised and this may have a material adverse effect on us.

Previous wording

Our primary use of cash is to fund our R&D activities and clinical development activities. We have funded our operations primarily through public offerings of our common stock and private placements of equity. As of March 31, 2024, we had cash totaling $16.0 million. We maintain cash at financial institutions that at times may exceed the Federal Deposit Insurance Corporation (“FDIC”) insured limits of $250 thousand per bank. Our cash balance includes liquid insured deposits, which are obligations of the program banks in which the deposits are held and qualify for FDIC insurance protection per depositor in each recognized legal category of account ownership in accordance with the rules of the FDIC. To date, we have not experienced any losses related to these funds.

Current wording

Our primary use of cash is to fund our R&D activities. We have funded our operations primarily through public offerings of our common stock and private placements of equity. As of June 30, 2024, we had cash totaling $27.9 million. We maintain cash at financial institutions that at times may exceed the Federal Deposit Insurance Corporation (“FDIC”) insured limits of $250 thousand per bank. Our cash balance includes liquid insured deposits, which are obligations of the program banks in which the deposits are held and qualify for FDIC insurance protection per depositor in each recognized legal category of account ownership in accordance with the rules of the FDIC. To date, we have not experienced any losses related to these funds.

Previous wording

The principal use of cash in operating activities is to fund our current expenditures in support of our R&D activities and clinical development activities. Financing activities currently represent the principal source of our cash flow.

Current wording

The principal use of cash in operating activities is to fund our current expenditures in support of our R&D activities. Financing activities currently represent the principal source of our cash flow.

Previous wording

Net cash used in operating activities was $6.4 million for the three months ended March 31, 2024, an increase of $3.9 million, or 152.9%, compared to $2.5 million for the three months ended March 31, 2023. Net cash used in operating activities for the three months ended March 31, 2024 consisted of net loss of $6.7 million, partially offset by (i) net non-cash expenses of $0.2 million and (ii) net cash provided by operating assets and liabilities of $0.1 million. Net cash used in operating activities for the three months ended March 31, 2023 consisted primarily of net loss of $2.6 million, partially offset by net cash used by operating assets and liabilities of $0.1 million.

Current wording

Net cash used in operating activities was $13.7 million for the six months ended June 30, 2024 and consisted of net loss of $16.8 million, partially offset by net cash provided by change in operating assets and liabilities of $2.6 million and non-cash charges totaling $0.5 million, which was primarily related to stock-based compensation and change in fair value of warrant liabilities. Net cash used in operating activities was $4.6 million for the six months ended June 30, 2023 and consisted of net loss of $3.3 million and non-cash credits totaling $3.0 million, which was primarily related to change in fair value of warrant liabilities, partially offset by net cash provided by changes in operating assets and liabilities of $1.8 million.