Vivani Medical Inc

Previous wording

Vivani Medical, Inc. (“Vivani,” the “Company,” “we,” “us,” “our” or similar terms) is a preclinical stage biopharmaceutical company which develops miniaturized, subdermal implants utilizing its proprietary NanoPortal™ technology to enable long-term, near constant-rate delivery of a broad range of medicines to treat chronic diseases. Vivani uses this platform technology to develop and potentially commercialize drug implant candidates, alone or in collaboration with pharmaceutical company partners to address a leading cause of poor clinical outcomes in the treatment of chronic disease, medication non-adherence. According to the U.S. Centers for Disease Control and Prevention, adherence is defined as the extent to which an individual’s behavior, including taking medications, corresponds to recommendations from a health care provider. An alarmingly high proportion of patients, approximately 50%, do not take their medicine as prescribed by their physician in the real world, a statistic which holds for both weekly injectable and daily oral medications. In addition, a recent study has shown that 64% of patients taking Wegovy® (semaglutide for weight management) discontinue therapy within the first year, a number which increases to 76% by year two. The Company is developing a portfolio of miniature, subdermal drug implant candidates that, unlike most oral and injectable medicines, are designed with the goal of guaranteeing medication adherence by delivering therapeutic drug levels for up to six months or longer. In addition, our aim is to minimize fluctuations in patients’ drug levels through the use of our proprietary NanoPortal™ implant technology, which may improve the tolerability profiles for medicines, including GLP-1 receptor agonists, that produce side effects associated with fluctuating drug levels in the blood.

Current wording

Vivani Medical, Inc. (“Vivani,” the “Company,” “we,” “us,” “our” or similar terms) is a preclinical stage biopharmaceutical company which develops miniaturized, subdermal implants utilizing its proprietary NanoPortal™ technology to enable ultra long-term, near constant-rate delivery of a broad range of medicines to treat chronic diseases. Vivani uses this platform technology to develop and potentially commercialize drug implant candidates, alone or in collaboration with pharmaceutical company partners to address a leading cause of poor clinical outcomes in the treatment of chronic disease, medication non-adherence. According to the U.S. Centers for Disease Control and Prevention, adherence is defined as the extent to which an individual’s behavior, including taking medications, corresponds to recommendations from a health care provider. An alarmingly high proportion of patients, approximately 50%, do not take their medicine as prescribed by their physician in the real world, a statistic which holds for both weekly injectable and daily oral medications. In addition, a recent study has shown that 64% of patients taking Wegovy® (semaglutide for weight management) discontinue therapy within the first year, a number which increases to 76% by year two. The Company is developing a portfolio of miniature, subdermal drug implant candidates that, unlike most oral and injectable medicines, are designed with the goal of guaranteeing medication adherence by delivering therapeutic drug levels for up to six months or longer. In addition, our aim is to minimize fluctuations in patients’ drug levels through the use of our proprietary NanoPortal™ implant technology, which may improve the tolerability profiles for medicines, including GLP-1 receptor agonists, that produce side effects associated with fluctuating drug levels in the blood.

Previous wording

In February 2024, Vivani announced positive preclinical weight loss data with NPM-115 (GLP-1 implant) comparable to semaglutide, the active ingredient in Ozempic®/Wegovy®, and a strategic shift to prioritize our obesity portfolio. In a study of high-fat diet-induced obese mice, NPM-115 generated weight loss of approximately 20% compared to a sham implant control after a 28-day treatment duration, comparable to weight loss observed in mice treated with semaglutide injections (Ozempic®/Wegovy®) in the same study. The Company also disclosed that semaglutide is the active pharmaceutical ingredient in NPM-139, a miniature, subdermal GLP-1 implant in development for chronic weight management, with the added potential benefit of once-yearly administration.

Current wording

In February 2024, Vivani announced positive preclinical weight loss data with a GLP-1 (exenatide) implant comparable to semaglutide, the active ingredient in Ozempic®/Wegovy®, and a strategic shift to prioritize our obesity portfolio including our NPM-115 program. In a study of high-fat diet-induced obese mice, NPM-115 generated weight loss of approximately 20% compared to a sham implant control after a 28-day treatment duration, comparable to weight loss observed in mice treated with semaglutide injections (Ozempic®/Wegovy®) in the same study. The Company also disclosed that semaglutide is the active pharmaceutical ingredient in NPM-139, a miniature, subdermal GLP-1 implant in development for chronic weight management, with the added potential benefit of once-yearly administration.

Previous wording

From inception, our operations have been funded primarily through the sales of our common stock and warrants. On March 1, 2024, the Company entered into the Securities Purchase Agreement relating to the issuance of 3,947,368 shares of the Company’s common stock, par value of $0.0001 per share (the “Common Stock”) and warrants to purchase up to an aggregate of 3,947,368 shares of common stock (the “Warrants”), to such investor at a purchase price of $3.80 per share and accompanying warrants in a registered direct offering (the “Offering”). The Warrants have an exercise price of $3.80 per share, are exercisable immediately upon issuance and will expire three years following the date of issuance. Simultaneously, the Company also entered into a placement agency agreement with Maxim Group LLC (“Maxim” and such agreement, the “Placement Agency Agreement,” and together with the Securities Purchase Agreement, the “Agreements”), who acted as the sole placement agent for the Offering. The gross proceeds of $15.0 million from the Offering, before paying the placement agent fees and other offering costs, were received on March 5, 2024. In connection with the Securities Purchase Agreement, the Company paid issuance costs of $1.3 million, resulting in net proceeds of $13.7 million, during thesix months ended June 30, 2024. For additional information, refer to Note 6. Equity Securities of the Notes to Condensed Consolidated Financial Statements in this quarterly report on Form 10-Q.

Current wording

From inception, our operations have been funded primarily through the sales of our common stock and warrants. On March 1, 2024, the Company entered into the Securities Purchase Agreement relating to the issuance of 3,947,368 shares of the Company’s common stock, par value of $0.0001 per share (the “common stock”) and warrants to purchase up to an aggregate of 3,947,368 shares of common stock (the “Warrants”), to such investor at a purchase price of $3.80 per share and accompanying warrants in a registered direct offering (the “Offering”). The Warrants have an exercise price of $3.80 per share, are exercisable immediately upon issuance and will expire three years following the date of issuance. Simultaneously, the Company also entered into a placement agency agreement with Maxim Group LLC (“Maxim” and such agreement, the “Placement Agency Agreement,” and together with the Securities Purchase Agreement, the “Agreements”), who acted as the sole placement agent for the Offering. The gross proceeds of $15.0 million from the Offering, before paying the placement agent fees and other offering costs, were received on March 5, 2024. In connection with the Securities Purchase Agreement, the Company paid issuance costs of $1.3 million, resulting in net proceeds of $13.7 million. For additional information, refer to Note 7. Equity Securities of the Notes to Condensed Consolidated Financial Statements in this quarterly report on Form 10-Q.

Previous wording

From time to time, we receive grants that help fund specific development programs. Any amounts received pursuant to grants are offset against the related operating expenses as the costs are incurred. Commencing in January 2018, we were awarded a $1.6 million grant (with the intent to fund $6.4 million over five years subject to annual review and approval) from the National Institutes of Health (the “NIH”) to fund the “Early Feasibility Clinical Trial of a Visual Cortical Prosthesis”. The final year of the grant ended in March 2024. During thesix months ended June 30, 2024 and 2023 total grants offsetting against operating expenses were $0.1 million and $0.3 million, respectively.

Current wording

From time to time, we receive grants that help fund specific development programs. Any amounts received pursuant to grants are offset against the related operating expenses as the costs are incurred. Commencing in January 2018, we were awarded a grant from the National Institutes of Health (the “NIH”) to fund the “Early Feasibility Clinical Trial of a Visual Cortical Prosthesis”. The final year of the grant ended in March 2024, however the NIH issued us a no-cost extension allowing us to utilize the unfunded amount through March 2025. During thenine months ended September 30, 2024 and 2023 total grants offsetting against operating expenses were $0.2 million and $0.4 million, respectively. As of September 30, 2024, we expect $70,000 will be available to offset future operating expenses.

Previous wording

We estimate that currently available cash will provide sufficient funds to enable the Company to meet its planned obligations into the second half of 2025. Our ability to continue as a going concern is dependent on our ability to raise additional capital and/or develop profitable operations through implementation of our business initiatives, however, there can be no assurances that we will be able to do so.

Current wording

We estimate that currently available cash will provide sufficient funds to enable the Company to meet its planned obligations for at least the next twelve months. Our ability to continue as a going concern is dependent on our ability to raise additional capital and/or develop profitable operations through implementation of our business initiatives, however, there can be no assurances that we will be able to do so.

Previous wording

There have been no material changes to our critical accounting policies during thesix months ended June 30, 2024.

Current wording

There have been no material changes to our critical accounting policies during thenine months ended September 30, 2024 compared to those disclosed in our Form 10-K for the year ended December 31, 2023.

Previous wording

*Research and development expense.*Research and development expense during thethree months ended June 30, 2024 was $3.5 million, compared to $3.9 million during thethree months ended June 30, 2023. Thedecrease of $0.4 million, or 9%, was primarily attributable to staffing reduction and reduced use of outside services from our neurostimulation division.

Current wording

*Research and development expense.*Research and development expense during thethree months ended September 30, 2024 was $4.2 million, compared to $4.4 million during thethree months ended September 30, 2023. Thedecrease of $0.2 million, or 5%, was primarily attributable to staffing reduction and reduced use of outside services from our neurostimulation division, partially offset by the increase in Alameda site facility expense from our Biopharma division.

Previous wording

General and administrative expense. General and administrative expense during thethree months ended June 30, 2024 was $2.2 million, compared to $3.1 million during thethree months ended June 30, 2023. Thedecrease of $1.0 million, or 31%, was primarily attributable to staffing reductions along with reduced outside legal services from our neurostimulation division, in addition to reduced professional services from our Biopharma division.

Current wording

General and administrative expense. General and administrative expense during thethree months ended September 30, 2024 was $2.1 million, compared to $2.7 million during thethree months ended September 30, 2023. Thedecrease of $0.6 million, or 22%, was primarily attributable to staffing reductions along with reduced outside legal services from our neurostimulation division, in addition to reduced professional services from our Biopharma division.

Previous wording

*Other income, net.*Other income, net during thethree months ended June 30, 2024 was $0.3 million, compared to $0.5 million during thethree months ended June 30, 2023. The change was not significant.

Current wording

*Other income, net.*Other income, net during thethree months ended September 30, 2024 was $0.3 million, compared to $0.4 million during thethree months ended September 30, 2023. The change was not significant.

Previous wording

*Research and development expense. *Research and development expense decreased by $0.6 million, or 7%, to $7.2 million in the firstsix months of 2024 from $7.8 million in the same period of 2023. The costs decreased was primarily attributable tostaffing reduction and reduced use of outside services fromour neurostimulation division, partially offset by the increase in Alameda site facility expense allocation from our Biopharma division.

Current wording

*Research and development expense. *Research and development expense decreased by $0.8 million, or 7%, to $11.4 million in the first nine months of 2024 from $12.3 million in the same period of 2023. The costs decreased was primarily attributable tostaffing reduction and reduced use of outside services fromour neurostimulation division, partially offset by the increase in Alameda site facility expense from our Biopharma division.

Previous wording

*General and administrative expense.*General and administrative expense decreased $1.1 million, or 19%, to $4.7 million in the firstsix months of 2024 from $5.8 million in the same period of 2023. This decrease was primarily attributable tostaffing reductions along with reduced outside legal services from our neurostimulation division.

Current wording

*General and administrative expense.*General and administrative expense decreased $1.7 million, or 20%, to $6.8 million in the first nine months of 2024 from $8.5 million in the same period of 2023. This decrease was primarily attributable tostaffing reductions along with reduced outside legal services from our neurostimulation division.

Previous wording

*Other income, net. *Other income, net during the six months ended June 30, 2024 was $0.5 million, compared to $0.8 million during the six months ended June 30, 2023. The decrease was due to lower interest associated with lower cash balances.

Current wording

*Other income, net. *Other income, net during the nine months ended September 30, 2024 was $0.8 million, compared to $1.1 million during the nine months ended September 30, 2023. The decrease was due to lower interest associated with lower cash balances.

Previous wording

On March 1, 2024, the Company entered into the Securities Purchase Agreement relating to the issuance of 3,947,368 shares of the Company’s common stock, par value of $0.0001 per share and warrants to purchase up to an aggregate of 3,947,368 shares of common stock at a purchase price of $3.80 per share and accompanying warrants in a registered direct offering. The Warrants have an exercise price of $3.80 per share, are exercisable immediately upon issuance and will expire three years following the date of issuance. In connection with the Placement Agency Agreement, the Company agreed to pay Maxim an aggregate cash fee of 7.0% of the aggregate proceeds raised from the sale and issuance of the shares of common stock and accompanying warrants. Pursuant to the Placement Agency Agreement, the Company also agreed to reimburse Maxim up to $65,000 for its legal expenses. The gross proceeds of $15.0 million from the Offering, before paying the placement agent fees and other estimated offering costs, were received on March 5, 2024. In connection with the Securities Purchase Agreement, the Company paid issuance costs of $1.3 million, resulting in net proceeds of $13.7 million, during thesix months ended June 30, 2024. For additional information, refer to Note 6. Equity Securities of the Notes to Condensed Consolidated Financial Statements in this quarterly report on Form 10-Q.

Current wording

On March 1, 2024, the Company entered into the Securities Purchase Agreement relating to the issuance of 3,947,368 shares of the Company’s common stock, par value of $0.0001 per share and warrants to purchase up to an aggregate of 3,947,368 shares of common stock at a purchase price of $3.80 per share and accompanying warrants in a registered direct offering. The Warrants have an exercise price of $3.80 per share, are exercisable immediately upon issuance and will expire three years following the date of issuance. In connection with the Placement Agency Agreement, the Company agreed to pay Maxim an aggregate cash fee of 7.0% of the aggregate proceeds raised from the sale and issuance of the shares of common stock and accompanying warrants. Pursuant to the Placement Agency Agreement, the Company also agreed to reimburse Maxim up to $65,000 for its legal expenses. The gross proceeds of $15.0 million from the Offering, before paying the placement agent fees and other estimated offering costs, were received on March 5, 2024. In connection with the Securities Purchase Agreement, the Company paid issuance costs of $1.3 million, resulting in net proceeds of $13.7 million, during thenine months ended September 30, 2024. For additional information, refer to Note 7. Equity Securities of the Notes to Condensed Consolidated Financial Statements in this quarterly report on Form 10-Q.

Previous wording

We estimate that currently available cash will provide sufficient funds to enable the Company to meet its planned obligations into the second half of 2025. Our ability to continue as a going concern is dependent on our ability to develop profitable operations through implementation of our business initiatives and/or raise additional capital, however, there can be no assurances that we will be able to do so.

Current wording

We estimate that currently available cash will provide sufficient funds to enable the Company to meet its planned obligations for at least the next twelve months. Our ability to continue as a going concern is dependent on our ability to develop profitable operations through implementation of our business initiatives and/or raise additional capital, however, there can be no assurances that we will be able to do so.

Previous wording

Cash, cash equivalents and restricted cash increased by $4.3 million from $22.0 million as of December 31, 2023 to $26.3 million as of June 30, 2024. Working capital was $20.6 million as of June 30, 2024, as compared to $17.3 million as of December 31, 2023, anincrease of $3.2 million. We use our cash and cash equivalents and working capital to fund our operating activities.

Current wording

Cash, cash equivalents and restricted cash decreased by $1.0 million from $22.0 million as of December 31, 2023 to $21.0 million as of September 30, 2024. Working capital was $15.1 million as of September 30, 2024, as compared to $17.3 million as of December 31, 2023, adecrease of $2.2 million. We use our cash and cash equivalents and working capital to fund our operating activities.

Previous wording

During thesix months ended June 30, 2024, we used $9.3 million of cash in operating activities, consisting primarily of a net loss of $11.4 million, partially offset by $1.0 million provided by a net change in operating assets and liabilities and non-cash items totaling $1.1 million for depreciation and amortization of property and equipment, stock-based compensation and lease expense.

Current wording

During thenine months ended September 30, 2024, we used $15.0 million of cash in operating activities, consisting primarily of a net loss of $17.4 million, partially offset by $0.7 million provided by a net change in operating assets and liabilities and non-cash items totaling $1.8 million for depreciation and amortization of property and equipment, stock-based compensation and lease expense.

Previous wording

During thesix months ended June 30, 2023, we used $12.5 million of cash in operating activities, consisting primarily of a net loss of $12.8 million and a net increase in net operating assets of $0.9 million, partially offset by non-cash charges of $1.2 million for depreciation and amortization of property and equipment, stock-based compensation and lease expense.

Current wording

During thenine months ended September 30, 2023, we used $20.2 million of cash in operating activities, consisting primarily of a net loss of $19.6 million and a net increase in net operating assets of $3.0 million, partially offset by non-cash charges of $2.4 million for depreciation and amortization of property and equipment, stock-based compensation and lease expense.

Previous wording

Cash used for investing activities during thesix months ended June 30, 2024 and 2023 was $0.2 million and $81,000, respectively, primarily attributable to the purchase of property and equipment.

Current wording

Cash used for investing activities during thenine months ended September 30, 2024 and 2023 was $0.3 million and $0.1 million, respectively, primarily attributable to the purchase of property and equipment.

Previous wording

Cash provided by financing activities was $13.8 million during thesix months ended June 30, 2024, primarily attributable to a securities purchase agreement with an institutional investor. For additional information, refer to Note 6. Equity Securities of the Notes to Condensed Consolidated Financial Statements in this quarterly report on Form 10-Q.

Current wording

Cash provided by financing activities was $14.2 million during thenine months ended September 30, 2024, primarily attributable to a securities purchase agreement with an institutional investor. For additional information, refer to Note 7. Equity Securities of the Notes to Condensed Consolidated Financial Statements in this quarterly report on Form 10-Q.