Vivani Medical, Inc.

Previous wording

Vivani Medical, Inc.(“Vivani,” the “Company,” “we,” “us,” “our” or similar terms) is a clinical stage biopharmaceutical company which develops miniature, ultra long-acting subdermal drug implants utilizing its proprietary NanoPortal™ technology, which is designed to enable ultra long-acting, 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 leading causes of poor clinical outcomes in the treatment of chronic disease, including medication non-adherence, drug tolerability and administration challenges faced by some populations. 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, or cannot, take their medicine as prescribed in the real world, a statistic that applies to both daily oral as well as weekly injectable medicines. For example, a recent study has shown that 64% of patients taking Wegovy® (semaglutide injection) discontinue therapy within the first year of treatment, a number that increases to 76% by the second year. Unfortunately, GLP-1 discontinuation may result in failure to achieve target outcomes and a quick reversal of the health benefits in the majority of patients.

Current wording

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, or cannot, take their medicine as prescribed in the real world, a statistic that applies to both daily oral as well as weekly injectable medicines. For example, a recent study has shown that 64% of patients taking Wegovy® (semaglutide injection) discontinue treatment within the first year, a number that increases to 76% by the second year. Unfortunately, GLP-1 discontinuation may result infailure to achieve target outcomes and a quick reversal of the health benefits in the majority of patients.

Previous wording

At Vivani, we are developing a portfolio of miniature, ultra long-acting subdermal drug implant candidates based on our NanoPortal technology that, unlike most oral and injectable medicines, are designed with the goal of guaranteeing medication adherence by delivering therapeutic drug levels for up tosix months or longer. In addition, we aim to minimize fluctuations in patients’ drug levels which may improve the tolerability of medicines, including GLP-1 receptor agonists, that produce side effects associated with fluctuating drug levels in the blood.

Current wording

At Vivani, we are developing a portfolio of miniature, ultra long-acting subdermal drug implant candidates based on our NanoPortal technology that, unlike most oral and injectable medicines, are designed with the goal of guaranteeing medication adherence by delivering therapeutic drug levels for up tosix months or longer. Our NanoPortal implant technology has the potential to reduce dosing frequency to 6 months or longer and allows for treatment to be discontinued at any time if necessary. In addition, we aim to minimize fluctuations in patients’ drug levels which may improve the tolerability of medicines, including GLP-1 receptor agonists which produce side effects that are associated with fluctuating drug levels in the blood.

Previous wording

Our emerging portfolio of miniature, ultra long-acting drug implants have the potential to revolutionize the treatment of chronic diseases by directly addressing poor medication adherence and improving drug tolerability, both of which have the potential to translate into better health outcomes for patients in the real-world setting. Vivani's priority program, NPM-139, is a miniature, six-month, GLP-1 (semaglutide) implant currently in development for chronic weight management in obese and overweight individuals. NPM-139 recently achieved encouraging preclinical data in rats by maintaining weight loss of approximately 20% versus controls for over asix month period. In other preclinical work, NPM-139 has demonstrated the potential for annual dosing. Other programs include, NPM-115 (high-dose exenatide implant) also in development for chronic weight management, NPM-119 (exenatide implant) in development for the treatment of type 2 diabetes, and OKV-119, another GLP-1 based implant in development for chronic weight management, the treatment of type 2 diabetes, and the treatment of cardiometabolic disorders in cats and dogs in collaboration with animal health partner Okava Pharmaceuticals, Inc. (“Okava”). On April 12, 2025, we entered into an amendment to a certain License and Supply Agreement with Okava to expand our ongoing collaboration to include dogs in the development of OKV-119, a long-acting GLP-1 therapy for weight management, type 2 diabetes and other cardiometabolic conditions.

Current wording

Our emerging portfolio of miniature, ultra long-acting drug implants have the potential to revolutionize the treatment of chronic diseases by directly addressing poor medication adherence and improving drug tolerability in patients, both of which have the potential to translate into better health outcomes for patients in the real-world setting. Vivani's lead program, NPM-139, is a miniature, six-month, GLP-1 (semaglutide) implant currently in development for chronic weight management in obese and overweight patients. NPM-139 recently achieved encouraging preclinical data in rats showing approximately 20% weight loss, as compared to a control group receiving sham implants, which was maintained for more than seven months. We are also developing NPM-133 (semaglutide implant) for the treatment of type-2 diabetes. Preliminary feasibility data support the additional potential benefit of once yearly dosing for both semaglutide implant programs, NPM-139 and NPM-133. In addition, we are also developing NPM-119 (exenatide implant) for the treatment of type 2 diabetes, NPM-115 (high-dose exenatide implant) for chronic weight management, and OKV-119, a GLP-1-based implant in development for chronic weight management and related conditions in companion cats and dogs. OKV-119 is being developed in collaboration with animal health partner Okava Pharmaceuticals, Inc. (“Okava”).

Previous wording

Vivani resulted from the business combination of Second Sight Medical Products, Inc. (“Second Sight”) and Nano Precision Medical, Inc. (“NPM”). On August 30, 2022, Second Sight and NPM completed their merger pursuant to which NPM became a wholly owned subsidiary of Second Sight and the combined company of NPM and Second Sight was renamed Vivani Medical, Inc. Vivani’s main priority is the further development of its lead program NPM-115, a miniature, six-month, GLP-1 implant candidate for chronic weight management in obese or overweight patients withone or more risk factors and further development of the balance of the company’s miniature, ultra long-acting drug implant portfolio. In parallel, Vivani’s management team remains committed to identifying and exploring strategic options that will enable further development of its pioneering neurostimulation systems from legacy company Second Sight aimed at helping patients recover critical body functions.

Current wording

Vivani resulted from the business combination of Second Sight Medical Products, Inc. (“Second Sight”) and Nano Precision Medical, Inc. (“NPM”). On August 30, 2022, Second Sight and NPM completed their merger pursuant to which NPM became a wholly owned subsidiary of Second Sight and the combined company of NPM and Second Sight was renamed Vivani Medical, Inc. Vivani’s main priority is the further development of its miniature, ultra long-acting drug implant programs. In parallel, Vivani’s management team remains committed to identifying and exploring strategic options that will enable further development of its pioneering neurostimulation systems from legacy company Second Sight which are aimed at helping patients recover critical body functions. As noted below, we subsequently contributed our Second Sight assets and certain liabilities to Cortigent, Inc. (“Cortigent”), our wholly owned subsidiary to advance our pioneering neurostimulation technology.

Previous wording

In February 2024, the Company also disclosed that semaglutide, the active ingredient in Ozempic®, Wegovy® and Rybelsus®, is the active pharmaceutical ingredient in NPM-139, another miniature, ultra long-acting subdermal GLP-1 implant in development for chronic weight management, further prioritizing our obesity portfolio. NPM-139 has the added potential benefit of once-yearly administration.

Current wording

In February 2024, the Company also disclosed that semaglutide, the active ingredient in Ozempic®, Wegovy® and Rybelsus®, is the active pharmaceutical ingredient in NPM-139, another miniature, ultra long-acting subdermal GLP-1 implant in development for chronic weight management, further prioritizing our obesity treatment portfolio. NPM-139 has the added potential benefit of once-yearly administration.

Previous wording

On May 28, 2024, Vivani announced the publication of positive weight loss data supporting the potential veterinary use of OKV-119, the company's miniature, ultra long-acting GLP-1 implant under development with partner Okava for the treatment of pre-diabetes, diabetes and obesity in companion felines. The device is intended to be conveniently inserted under the skin during routine veterinary visits and is being designed to deliversix months of GLP-1 therapy with a single administration. We believe thissix-month administration profile is important commercially in the veterinary setting due to the infrequent cadence of veterinary visits.

Current wording

On May 28, 2024, Vivani announced the publication of positive weight loss data supporting the potential veterinary use of OKV-119, the Company’s miniature, ultra long-acting GLP-1 implant under development with partner Okava for the treatment of pre-diabetes, diabetes and obesity in companion felines. The device is intended to be conveniently inserted under the skin during routine veterinary visits and is being designed to deliver six months of GLP-1 therapy with a single administration. We believe this six-month administration profile is important commercially in the veterinary setting due to the infrequent cadence of veterinary visits.

Previous wording

On September 4, 2024, Vivani announced positive preclinical liver fat results with its miniature, ultra long-acting GLP-1 implant currently under development for chronic weight management in obese and overweight individuals and type 2 diabetes. The Company's GLP-1 (exenatide) implant produced sham-implant adjusted liver fat reduction of 82% in an obese mouse model from a single administration with expected twice-yearly dosing. These liver fat data are consistent with published results from similar investigations with semaglutide, the active pharmaceutical ingredient in Ozempic® and Wegovy®.

Current wording

On September 4, 2024, Vivani announced positive preclinical liver fat results with its miniature, ultra long-acting GLP-1 implant currently under development for chronic weight management in obese and overweight individuals and type 2 diabetes. The Company's GLP-1 (exenatide) implant produced sham-implant adjusted liver fat reduction of 82% in an obese mouse model from a single administration with expected twice-yearly dosing. These liver fat data are consistent with published results from similar investigations with semaglutide.

Previous wording

On July 14, 2023, we filed an Investigational New Drug Application (“IND”) for NPM-119 (GLP-1 implant) with the U.S. Food and Drug Administration (the “FDA”), to support the initiation of a first-in-human study of an exenatide implant in patients with type 2 diabetes. On August 18, 2023, FDA provided written notification that the study was on full clinical hold, primarily due to insufficient Chemistry, Manufacturing, and Controls (“CMC”) information to assess the risk to human subjects. The primary objective of this first-in-human clinical study was to evaluate the safety, tolerability and pharmacokinetics of NPM-119 in type 2 diabetes patients. This initial study design also incorporated Bydureon BCise® (exenatide injection) for comparison purposes.

Current wording

On July 14, 2023, we filed an Investigational New Drug Application (“IND”) for NPM-119 (exenatide implant) with the U.S. Food and Drug Administration (the “FDA”), to support the initiation of a first-in-human study of our GLP-1 implant in patients with type 2 diabetes. On August 18, 2023, FDA provided written notification that the study was on full clinical hold, primarily due to insufficient Chemistry, Manufacturing, and Controls (“CMC”) information to assess the risk to human subjects. The primary objective of this first-in-human clinical study was to evaluate the safety, tolerability and pharmacokinetics of NPM-119 in type 2 diabetes patients. This initial study design also incorporated Bydureon BCise® (exenatide injection) for comparison purposes.

Previous wording

On July 11, 2024, the Company provided an update of the clinical development plans for NPM-115, the clinical program associated with the miniature, long-acting GLP-1 (high-dose exenatide) implant for chronic weight management in obese and overweight individuals. The Company has redesigned the first-in-human study, LIBERATE-1™, initially intended to explore the safety, tolerability and pharmacokinetics of its exenatide implant in patients with type 2 diabetes, to evaluate the implant in obese and overweight patients.

Current wording

On July 11, 2024, the Company provided an update of the clinical development plans for NPM-115, the clinical program associated with the miniature, ultra long-acting GLP-1 (high-dose exenatide) implant for chronic weight management in obese and overweight individuals. The Company redesigned the first-in-human study, LIBERATE-1™, initially intended to explore the safety, tolerability and pharmacokinetics of its exenatide implant in patients with type 2 diabetes, to evaluate the implant in obese and overweight individuals.

Previous wording

On September 26, 2024, the Company reported receiving regulatory approval to initiate its first-in-human clinical trial with NPM-115, a miniature, ultra long-acting GLP-1 (exenatide) implant in obese and overweight individuals in Australia. This clinical trial, known as LIBERATE-1, will investigate the safety, tolerability and full pharmacokinetic profile of an exenatide implant. The trial also represents the first clinical application of the Company’s proprietary NanoPortal drug implant technology. LIBERATE-1 was redesigned to enroll participants who will be titrated on weekly semaglutide injections for 8 weeks (0.25 mg/week for 4 weeks followed by 0.5 mg/week for 4 weeks) before being randomized to receive a single administration of Vivani’s exenatide implant (n=8), weekly exenatide injections (n=8), or weekly 1 mg semaglutide injections (n=8) for a 9-week treatment duration. Changes in weight will be measured. The trial was initiated at the end of 2024 with data projected to be available in mid-2025.

Current wording

On September 26, 2024, the Company reported receiving regulatory approval to initiate its first-in-human clinical trial with NPM-115, a miniature, ultra long-acting GLP-1 (exenatide) implant in obese and overweight individuals in Australia. This clinical trial, known as LIBERATE-1, investigated the safety, tolerability and full pharmacokinetic profile of our exenatide implant. The trial also represented the first clinical application of the Company’s proprietary NanoPortal drug implant technology. LIBERATE-1 was redesigned to enroll participants who were titrated on weekly semaglutide injections for 8 weeks (0.25 mg/week for 4 weeks followed by 0.5 mg/week for 4 weeks) before being randomized to receive a single administration of Vivani’s exenatide implant (n=8), weekly exenatide injections (n=8), or weekly 1 mg semaglutide injections (n=8) for a 9-week treatment duration. The trial was initiated at the end of 2024 with top-line data was released in August 2025.

Previous wording

On December 19, 2024, Vivani announced that screening and enrollment of LIBERATE-1, the First-in-Human clinical trial with a GLP-1 implant in obese and overweight patients, was initiated at two study centers in Australia. The primary objective of the study is to investigate the safety, tolerability and full pharmacokinetic profile of an exenatide implant in obese or overweight individuals. Consistent with previous guidance, study results are anticipated to be reported in mid-2025.

Current wording

On December 19, 2024, Vivani announced that screening and enrollment of LIBERATE-1, the First-in-Human clinical trial with a GLP-1 implant in obese and overweight patients, was initiated at two study centers in Australia. The primary objective of the study was to investigate the safety, tolerability and full pharmacokinetic profile of an exenatide implant in obese or overweight individuals.

Previous wording

On March 13, 2025, the Company announced the successful administration of its first GLP-1 (exenatide) implant in the LIBERATE-1 clinical trial. This milestone marks a critical step toward addressing one of healthcare’s most pressing challenges: medication adherence in metabolic diseases including chronic weight management and type 2 diabetes. The Company also announced full enrollment in the LIBERATE-1 study, which was achieved in just four weeks after enrollment of the first subject, signaling early potential interest for this six-month, subdermal GLP-1 implant. This rapid enrollment is expected to reduce overall company expenditures during the course of the study, and it reaffirmed previous estimates that top-line results should be available in mid-2025.

Current wording

On March 13, 2025, the Company announced the successful administration of its first GLP-1 (exenatide) implant in the LIBERATE-1 clinical trial. This milestone marked a critical step toward addressing one of healthcare’s most pressing challenges: medication adherence in metabolic diseases including chronic weight management and type 2 diabetes. The Company also announced full enrollment in the LIBERATE-1 study, which was achieved in just four weeks after enrollment of the first subject, signaling early potential interest for this six-month, subdermal GLP-1 implant.

Previous wording

On August 5, 2025 Vivani announced plans to support the rapid advancement of NPM-139, a novel semaglutide implant, based on promising results from the LIBERATE-1 clinical study and additional positive data from a preclinical study with a semaglutide implant. LIBERATE-1, the first-in-human application of Vivani's proprietary NanoPortal implant technology, demonstrated a positive safety and tolerability profile and encouraging performance data, thus meeting the study's primary objectives. This study provided information on the GLP-1 exposure levels obtained with an exenatide configuration, thereby paving the road for future clinical development of the technology, not only for exenatide (NPM-115 and NPM-119), but also for semaglutide (NPM-139) and other applications of NanoPortal technology that the Company may pursue in the future. Vivani also announced new NPM-139 (semaglutide implant)preclinical feasibility data that demonstrated an approximately 20% weight loss maintained for more than 6 months with a single implant. This new semaglutide data also continues to support the potential for a semaglutide implant with annual dosing. Based on the LIBERATE-1 data supporting the clinical application of the NanoPortal platform technology, and the preclinical weight loss data with a semaglutide implant configuration,Vivani announced plans to prioritize advancement of NPM-139, with clinical development expected to begin in 2026.

Current wording

On August 5, 2025, Vivani announced plans to rapidly advance NPM-139, a novel semaglutide implant, based on promising results from the LIBERATE-1 clinical study and additional positive data from a preclinical study with a semaglutide implant. LIBERATE-1, the first-in-human application of Vivani's proprietary NanoPortal implant technology, demonstrated a positive safety and tolerability profile and encouraging performance data, thus meeting the study's primary objec tives. This study provided information on the GLP-1 exposure levels obtained with an exenatide configuration, thereby paving the road for future clinical development of the technology, not only for exenatide implants (NPM-115 and OKV-119), but also for semaglutide implants (NPM-139 and NPM-133) and other applications of NanoPortal technology that the Company may pursue in the future. Vivani also announced new NPM-139 (semaglutide implant) preclinical feasibility data that demonstrated an approximately 20% weight loss with a single implant, which had been maintained for more than six months at the time of the announcement. This new semaglutide data also continues to support the potential for a semaglutide implant with annual dosing. Based on the LIBERATE-1 data supporting the clinical application of the NanoPortal platform technology, and the preclinical weight loss data with a semaglutide implant configuration, Vivani announced plans to prioritize advancement of NPM-139, with clinical development expected to begin in 2026.

Previous wording

In December 2022, we contributed our neurostimulation assets and certain liabilities from legacy company Second Sight to Cortigent, Inc. (“Cortigent”), a wholly owned subsidiary of Vivani to advance the Company’s pioneering neurostimulation technology. Cortigent has 5,000,000 shares of common stock outstanding, all owned by Vivani. On March 12, 2025, Vivani announced efforts to file a Form 10 with the U.S. Securities and Exchange Commission (“SEC”) to support the spin-off of Cortigent into a fully independent, publicly traded company. Vivani announced the filing of the Cortigent Form-10 registration statement on May 29, 2025. The strategic goal of this transaction is to createtwo focused companies dedicated to driving current and future value in their respective therapeutic areas of expertise.

Current wording

In December 2022, we contributed our neurostimulation assets and certain liabilities from legacy company Second Sight to Cortigent, our wholly owned subsidiary to advance our pioneering neurostimulation technology. Cortigent had 5,000,000 shares of common stock outstanding, all owned by Vivani. On March 12, 2025, Vivani announced efforts to file a Form 10 with the U.S. Securities and Exchange Commission (“SEC”) to support the spin-off of Cortigent into a fully independent, publicly traded company. Vivani announced the filing of the Cortigent Form-10 registration statement on May 29, 2025. The strategic goal of this transaction is to create two focused companies dedicated to driving current and future value in their respective therapeutic areas of expertise.

Previous wording

On August 25, 2023, the Company and Cortigent entered into an Amendment 1 (the “Amendment”) to the Transition Funding, Support and Services Agreement dated March 19, 2023 (the “TFSSA”). Pursuant to the TFSSA, Vivani has agreed to advance funds and provide or cause to be provided to Cortigent the services and funding intended to cover salaries and related costs, rent and other overhead in order to permit Cortigent to operate in substantially the same manner in which business operations of Cortigent were previously operated by Second Sight, prior to the formation of Cortigent, Efforts to support a successful initial public offering of Cortigent ceased in March 2025 and efforts are now focused on a potential spinoff with the filing of a Form 10 registration statement. The TFSSA terminated effective December 31, 2024. If the spinoff is successful, the loan payable from Cortigent to Vivani would be forgiven.

Current wording

On August 25, 2023, the Company and Cortigent entered into an Amendment 1 (the “Amendment”) to the Transition Funding, Support and Services Agreement dated March 19, 2023 (the “TFSSA”). Pursuant to the TFSSA, Vivani has agreed to advance funds and provide or cause to be provided to Cortigent the services and funding intended to cover salaries and related costs, rent and other overhead in order to permit Cortigent to operate in substantially the same manner as Second Sight prior to the formation of Cortigent. Efforts to support a successful initial public offering of Cortigent ceased in March 2025 and efforts are now focused on a potential spinoff with the filing of a Form 10 registration statement. The TFSSA terminated effective December 31, 2024. If the spinoff is successful, the loan payable from Cortigent to Vivani will be forgiven.

Previous wording

On May 29, 2025, Vivani announced that Cortigent, Inc, a wholly owned subsidiary of the Company that develops brain implant devices to help patients recover critical body functions, had filed a Form 10 registration statement with the SEC to spin off Cortigent as an independent, publicly traded Nasdaq company. The strategic goal of this transaction is to createtwo focused companies dedicated to driving current and future value in their respective therapeutic areas of expertise. Vivani’s board of directors has authorized management to proceed with a plan to spin off its Cortigent neuromodulation business. The spin-off is planned to be completed during third or fourth quarter 2025, subject to the satisfaction of certain conditions, including, among others, final approval of Vivani’s board of directors, receipt of a favorable opinion that the transaction will qualify for non-recognition of gain or loss as a result of receipt of Cortigent shares for U.S. Federal Income Tax purposes, and SEC and Nasdaq approval.

Current wording

On May 29, 2025, Vivani announced that Cortigent had filed a Form 10 registration statement with the SEC to spin off Cortigent as an independent, publicly traded Nasdaq company. The strategic goal of this transaction is to create two focused companies dedicated to driving current and future value in their respective therapeutic areas of expertise. Vivani’s board of directors authorized management to proceed with a plan to spin off its Cortigent neuromodulation business. The spin-off was planned to be completed during fourth quarter 2025, subject to the satisfaction of certain conditions, including, among others, final approval of Vivani’s board of directors, receipt of a favorable opinion that the transaction will qualify for non-recognition of gain or loss as a result of receipt of Cortigent shares for U.S. Federal Income Tax purposes, and SEC and Nasdaq approval.

Previous wording

On April 22, 2024, the Company entered into an Open Market Sale Agreement SM (the “Sales Agreement”) with Jefferies LLC (“Jefferies”), under which the Company may offer and sell, from time to time at its sole discretion, shares of the common stock, having an aggregate offering price of up to $75.0 million through Jefferies as its sales agent. Also on April 22, 2024, the Company filed a Registration Statement on Form S-3, which was declared effective on May 3, 2024, including a sales agreement prospectus relating to the offering of up to $75.0 million shares of its common stock in accordance with the Sales Agreement. 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. During the three months ended June 30, 2025 the Company incurred no costs and realized no proceeds from issuing common stocks under the Sales Agreement with Jefferies.

Current wording

On April 22, 2024, the Company entered into an Open Market Sale Agreement SM (the “Sales Agreement”) with Jefferies LLC (“Jefferies”), under which the Company may offer and sell, from time to time at its sole discretion, shares of the common stock, having an aggregate offering price of up to $75.0 million through Jefferies as its sales agent. Also on April 22, 2024, the Company filed a Registration Statement on Form S-3, which was declared effective on May 3, 2024, including a sales agreement prospectus relating to the offering of up to $75.0 million shares of its common stock in accordance with the Sales Agreement. 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. During thethree months ended September 30, 2025 the Company incurred no costs and realized no proceeds from issuing common stocks under the Sales Agreement with Jefferies.

Previous wording

On March 26, 2025, the Company entered into a private sale transaction with an entity affiliated withone of its directors whereby the Company shall sell an aggregate of 7,366,071 shares of the Company’s common stock to the entity, inone or more closings as provided in the purchase agreement, at a price of $1.12 per share, which was the closing price of the Company’s common stock on Nasdaq, subject to adjustment for reverse and forward stock splits, stock dividends, stock combinations and other similar transactions of the common stock that occur after the date of the private sale transaction. The gross proceeds from this private sale transaction will be approximately $8.25 million.

Current wording

On March 26, 2025, the Company entered into a private sale transaction with an entity affiliated withone of its directors whereby the Company shall sell an aggregate of 7,366,071 shares of the Company’s common stock to the entity, in five closings as provided in the purchase agreement, at a price of $1.12 per share, which was the closing price of the Company’s common stock on Nasdaq, subject to adjustment for reverse and forward stock splits, stock dividends, stock combinations and other similar transactions of the common stock that occur after the date of the private sale transaction. The gross proceeds from this private sale transaction will be approximately $8.25 million.

Previous wording

On August 11, 2025, the Company entered into a share purchase agreement with an entity affiliated with one of its directors and another investor whereby the Company shall sell an aggregate of 7,936,507 shares of the Company’s common stock to the entity and other investor, in twelve closings as provided in the share purchase agreement, at a price of $1.26 per share, which was the closing price of the Company’s common stock on Nasdaq on August 11, 2025, subject to adjustment for reverse and forward stock splits, stock dividends, stock combinations and other similar transactions of the common stock that occur after the date of the share purchase agreement. The gross proceeds from this private sale transaction will be approximately $10.0 million.

Current wording

On August 11, 2025, the Company entered into a share purchase agreement with an entity affiliated withone of its directors and another investor whereby the Company shall sell an aggregate of 7,936,507 shares of the Company’s common stock to the entity and other investor, intwelve closings as provided in the share purchase agreement, at a price of $1.26 per share, which was the closing price of the Company’s common stock on Nasdaq on August 11, 2025, subject to adjustment for reverse and forward stock splits, stock dividends, stock combinations and other similar transactions of the common stock that occur after the date of the share purchase agreement. The gross proceeds from this private sale transaction will be approximately $10.0 million.

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 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 thesix months ended June 30, 2025 and 2024 total grants offsetting against operating expenses were $35,000 and $0.1 million, respectively. As of June 30, 2025, we expect $0 will be available to offset future operating expenses.

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, 2025 and 2024 total grants offsetting against operating expenses were $0.0 million and $0.2 million, respectively. As of September 30, 2025, we expect $0 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 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.

Current wording

We estimate that currently available cash will provide sufficient funds to enable the Company to meet its planned obligations into 2027. Our ability to continue as a going concern is dependent on our ability to raise additional capital, however, there can be no assurances that we will be able to do so.

Previous wording

We are subject to the risks and uncertainties associated with a business with no revenue that is developing a novel pharmaceutical product candidates and medical device candidates, including limitations on our operating capital resources and uncertain demand for our products. We expect our operating expenses to increase significantly as we continue our business operations, particularly as we prepare to initiate additional clinical trials and conduct our other research and development activities. Conducting clinical trials is a time-consuming, expensive and uncertain process that takes many years to complete and we may never generate the necessary data or results required to obtain marketing approval. We do not expect revenues until we are successful in completing the development and obtaining marketing approval for our products. We expect expenses to increase in connection with our ongoing activities, particularly as we initiate clinical trials, initiate new research and development projects and seek marketing approval for any product candidates that we successfully develop. If we are required to conduct additional nonclinical or clinical activities preclinical or IND-enabling activities such as additional pre-clinical, our overall expenditures would increase. In addition, if we obtain marketing approval, we expect to incur significant additional expenses related to sales, marketing, distribution and other commercial infrastructure to commercialize such product. In addition, our product candidates, if approved, may not achieve commercial success. We incur significant costs associated with operating as a public company in a regulated industry.

Current wording

We are subject to the risks and uncertainties associated with a business with no revenue that is developing a novel pharmaceutical product candidates and medical device candidates, including limitations on our operating capital resources and uncertain demand for our products. We expect our operating expenses to increase significantly as we continue our business operations, particularly as we prepare to initiate additional clinical trials and conduct our other research and development activities. Conducting clinical trials is a time-consuming, expensive and uncertain process that takes many years to complete, and we may never generate the necessary data or results required to obtain marketing approval. We do not expect revenues until we are successful in completing the development and obtaining marketing approval for our products. We expect expenses to increase in connection with our ongoing activities, particularly as we initiate clinical trials, initiate new research and development projects and seek marketing approval for any product candidates that we successfully develop. If we are required to conduct additional nonclinical or clinical activities, or IND-enabling activities, our overall expenditures would increase. In addition, if we obtain marketing approval, we expect to incur significant additional expenses related to sales, marketing, distribution and other commercial infrastructure to commercialize such product. In addition, our product candidates, if approved, may not achieve commercial success. We incur significant costs associated with operating as a public company in a regulated industry.

Previous wording

Cash, cash equivalents and restricted cash decreased by $11.6 million from $19.7 million as of December 31, 2024 to $8.1 million as of June 30, 2025. Working capital was $2.0 million as of June 30, 2025, as compared to $14.5 million as of December 31, 2024, a decrease of $12.5 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 $15.7 million from $19.7 million as of December 31, 2024 to $4.0 million as of September 30, 2025. Working capital decreasedby $17.1 million from $14.5 million as of December 31, 2024 to negative $2.7 million as of September 30, 2025. We use our cash and cash equivalents and working capital to fund our operating activities.

Previous wording

*Research and development expense.*Research and development expense during thethree months ended June 30, 2025 was $4.8 million, compared to $3.5 million during thethree months ended June 30, 2024. Theincrease of $1.2 million, or 35%, was primarily attributable to increased research and development expense from our Biopharma division.

Current wording

*Research and development expense.*Research and development expense during thethree months ended September 30, 2025 was $4.5 million, compared to $4.2 million during thethree months ended September 30, 2024. Theincrease of $0.3 million, or 8%, was primarily attributable to increased research and development expense from our Biopharma division.

Previous wording

General and administrative expense. General and administrative expense during thethree months ended June 30, 2025 was $2.7 million, compared to $2.2 million during thethree months ended June 30, 2024. Theincrease of $0.5 million, or 25%, was primarily attributable to increased professional services from our Biopharma division.

Current wording

General and administrative expense. General and administrative expense during thethree months ended September 30, 2025 was $2.2 million, compared to $2.1 million during thethree months ended September 30, 2024. Theincrease of $0.1 million, or 5%, was primarily attributable to increased professional services from our Biopharma division.

Previous wording

*Other income, net.*Other income, net during thesix months ended June 30, 2025 was $0.6 million, compared to $0.5 million during thesix months ended June 30, 2024. The change was not significant.

Current wording

*Other income, net.*Other income, net during thethree months ended September 30, 2025 was $0.2 million, compared to $0.3 million during thethree months ended September 30, 2024. The decrease of $0.1 million was due to lower interest income.

Previous wording

*Research and development expense.*Research and development expense during thesix months ended June 30, 2025 was $9.0 million, compared to $7.2 million during thesix months ended June 30, 2024. Theincrease of $1.7 million, or 24%, was primarily attributable to increased research and development expense from our Biopharma division.

Current wording

*Research and development expense.*Research and development expense during thenine months ended September 30, 2025 was $13.5 million, compared to $11.4 million during thenine months ended September 30, 2024. Theincrease of $2.1 million, or 18%, was primarily attributable to increased research and development expense from our Biopharma division.

Previous wording

General and administrative expense. General and administrative expense during thesix months ended June 30, 2025 was $5.0 million, compared to $4.7 million during thesix months ended June 30, 2024. Theincrease of $0.4 million, or 8%, was primarily attributable to increased professional services from both Neurostimulation Division and Biopharma division.

Current wording

General and administrative expense. General and administrative expense during thenine months ended September 30, 2025 was $7.3 million, compared to $6.8 million during thenine months ended September 30, 2024. Theincrease of $0.5 million, or 7%, was primarily attributable to increased professional services from both Neurostimulation Division and Biopharma division.

Previous wording

*Other income, net.*Other income, net during thethree months ended June 30, 2025 was $0.3 million, compared to $0.3 million during thethree months ended June 30, 2024. The change was not significant.

Current wording

*Other income, net.*Other income, net during thenine months ended September 30, 2025 was $0.8 million, compared to $0.8 million during thenine months ended September 30, 2024. The change was not significant.

Previous wording

During the six 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 the nine months ended September 30, 2025, we used $17.6 million of cash in operating activities, consisting primarily of a net loss of $20.0 million, partially offset by $0.9 million provided by a net change in operating assets and liabilities, and non-cash items totaling $1.5 million for depreciation and amortization of property and equipment, stock-based compensation and lease expense.

Previous wording

During the six months ended June 30, 2025, we used $11.3 million of cash in operating activities, consisting primarily of a net loss of $13.4 million, partially offset by $1.1 million 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 the nine 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

Cash used for investing activities during the six months ended June 30, 2025 and 2024 was $76,000 and $219,000 respectively, primarily attributable to the purchase of property and equipment.

Current wording

Cash used for investing activities during the nine months ended September 30, 2025 and 2024 was $0.9 million and $0.3 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.

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.