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• Data demonstrate biovascular pancreas may have the potential to provide an effective and safe method for pancreatic islet cell transplantation for the treatment of type 1 diabetes
• Data published in the Journal of Tissue Engineering

DURHAM, N.C., Aug. 11, 2021 (GLOBE NEWSWIRE) — Humacyte, Inc., a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, announced laboratory and preclinical data demonstrating the potential to engineer a biovascular pancreas as a method to transplant pancreatic islet cells for the long-term treatment of type 1 diabetes have been published in the Journal of Tissue Engineering. The manuscript, entitled, “Development of a Bioartificial Vascular Pancreas,” reports in vivo, in vitro and in silico data supporting the potential of the biovascular pancreas technology platform to overcome current limitations of islet cell transplantation and offer an effective way to transplant pancreatic islet cells.

Type 1 diabetes, caused by auto-immune destruction of insulin-producing cells in the islets of the pancreas, affects more than 1.2 million people in the United States and less than one-third of patients achieve consistent target blood sugar levels. The global market for the treatment of type 1 diabetes is estimated to be approximately $60 billion per year. Curative treatment options for type 1 diabetes are inadequate and include pancreas transplantation, which has major risks, including morbidity and cost, and the transplantation of pancreatic islet cells which is limited by insufficient oxygen transfer, leading to islet loss. Humacyte is developing the biovascular pancreas (BVP), leveraging its human acellular vessels (HAVs) as a vascular scaffold, to be implanted in an outpatient procedure.

“Type 1 diabetes is a devastating disease that impacts the health and quality of life of patients who have to endure daily glucose monitoring and injections or face organ transplantation,” said Allan Douglas Kirk, M.D., Ph.D., FACS, chairman of the department of surgery, David C. Sabiston Jr. Professor of Surgery and a professor of immunology and pediatrics at the Duke University School of Medicine, who is not affiliated with the study. “An incredible unmet need exists for curative treatment options that can overcome the limitations of current organ and islet transplantation procedures and provide life-long benefit to patients. This approach of developing a biovascular pancreas is interesting and certainly worthy of pursuit.”

The published data expand upon findings presented in June 2021 at the American Transplant Congress 2021 Virtual Connect, which demonstrated that pancreatic islet cells embedded in the outer matrix of an acellular vessel can create a working BVP in preclinical models. Laboratory data showed that the BVP, when implanted as an arterial graft, provided adequate survival for islet cells, overcoming the limitation of insufficient oxygen transfer that has historically inhibited islet transplantation. In addition, results from a preclinical study in nude rats demonstrated that the BVP was able to restore animals to near-normal glycemia durably for 90 days post-transplantation. Further, a preclinical study in a pig model demonstrated that the BVP was scalable to near-human-sized recipients.

“We are excited to share this data that supports the application of a biovascular pancreas to provide an effective method for the treatment of type 1 diabetes,” said Laura Niklason, M.D., Ph.D., Chief Executive Officer of Humacyte. “Islet cell transplantation can be an important long-term treatment option for people with type 1 diabetes who no longer make their own insulin. However, current methods of transplantation often lead to insufficient oxygenation of islet cells and, ultimately, to cell death. We are encouraged by these findings that demonstrate the potential of our biovascular pancreas to overcome these limitations and look forward to continuing development of this important pipeline product of our HAV platform.”

The full manuscript can be accessed at https://journals.sagepub.com/doi/full/10.1177/20417314211027714.

On February 17, 2021, Alpha Healthcare Acquisition Corp. (Nasdaq: AHAC) (“AHAC”), a special purpose acquisition company, and Humacyte announced the execution of a definitive business combination agreement along with a fully committed $175 million PIPE financing agreement.

About Humacyte

Humacyte, Inc., is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues and organs designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries and chronic conditions. Humacyte’s initial opportunity, a portfolio of human acellular vessels (HAVs), is currently in late-stage clinical trials targeting multiple vascular applications, including vascular trauma repair, arteriovenous access for hemodialysis, and peripheral arterial disease. Pre-clinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s HAVs were the first product to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) expedited review designation and received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com.

About Alpha Healthcare Acquisition Corp.

Alpha Healthcare Acquisition Corp. (ticker: AHAC) is a special purpose acquisition company formed for the purpose of effecting a business combination with one or more businesses in the healthcare sector (“AHAC”). The company was founded by Mr. Rajiv Shukla who has two decades of buyouts, investments and operations experience in the healthcare industry. Mr. Shukla previously served as Chairman and Chief Executive Officer of Constellation Alpha Capital Corp., a Nasdaq-listed special purpose acquisition company, that merged with DermTech, Inc (ticker: DMTK) in August 2019. On February 17, 2021, AHAC announced a definitive agreement to merge with Humacyte, Inc. along with a concurrent fully committed PIPE placement of $175 million of AHAC common shares at a price of $10.00 per share.

Important Information About the Merger and Where to Find It

A full description of the terms of the business combination is provided in a registration statement on Form S-4 filed with the SEC by AHAC that includes a prospectus with respect to the Combined Company’s securities to be issued in connection with the business combination and a proxy statement with respect to the shareholder meeting of AHAC to vote on the business combination. AHAC urges its investors, shareholders, and other interested persons to read the proxy statement/ prospectus as well as other documents filed with the SEC because these documents contain important information about AHAC, Humacyte and the business combination. The definitive proxy statement/prospectus included in the registration statement was mailed to shareholders of AHAC as of a record date to be established for voting on the proposed business combination. Shareholders will also be able to obtain a copy of the Form S-4, including the proxy statement/prospectus, and other documents filed with the SEC without charge, by directing a request to: Alpha Healthcare Acquisition Corp., Attn: Secretary, 1177 Avenue of the Americas, 5^th Floor, New York, New York 10036. The preliminary and definitive proxy statement/prospectus to be included in the registration statement, can also be obtained, without charge, at the SEC’s website (www.sec.gov).

Participants in the Solicitation

AHAC and Humacyte and their respective directors and executive officers may be considered participants in the solicitation of proxies with respect to the proposed business combination described in this press release under the rules of the SEC. Information about the directors and executive officers of AHAC is set forth in AHAC’s final prospectus filed with the SEC pursuant to Rule 424(b) of the Securities Act of 1933, as amended (the “Securities Act”) on September 17, 2020, and is available free of charge at the SEC’s website at www.sec.gov or by directing a request to: Alpha Healthcare Acquisition Corp., Attn: Secretary, 1177 Avenue of the Americas, 5^th Floor, New York, New York 10036. Information regarding the persons who may, under the rules of the SEC, be deemed participants in the solicitation of the AHAC shareholders in connection with the proposed business combination is set forth in the registration statement containing the proxy statement/prospectus for the proposed business combination. These documents can be obtained free of charge from the sources indicated above.

Forward-Looking Statements

This press release contains forward-looking statements that are based on beliefs and assumptions and on information currently available. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, statements regarding
the initiation, timing, progress, and results of our clinical trials; the anticipated characteristics and performance of our HAVs, our ability to successfully complete, clinical trials for our HAVs; the anticipated benefits of our HAVs relative to existing alternatives; the commercialization of our HAVs and our ability to manufacture at commercial scale; the implementation of our business model, strategic plans for our business; the scope of protection we are able to establish and maintain for intellectual property rights covering our HAVs and related technology; the timing or likelihood of regulatory filings and approvals; timing, scope, and rate of reimbursement for our HAVs; our estimated available market opportunity; the proposed business combination, including the timing and structure of the business combination, the proceeds of the business combination, and the benefits of the business combination. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of significant risks and uncertainties that could cause actual results to differ materially from expected results, including, among others, the ability to complete the business combination due to the failure to obtain approval from AHAC’s shareholders or satisfy other closing conditions in the Business Combination Agreement, the occurrence of any event that could give rise to the termination of the Business Combination Agreement, the ability to recognize the anticipated benefits of the business combination, the outcome of any legal proceedings that may be instituted against AHAC or Humacyte following announcement of the proposed business combination and related transactions, the impact of COVID-19 on Humacyte’s business and/or the ability of the parties to complete the business combination, the ability to obtain or maintain the listing AHAC’s common stock on Nasdaq following the proposed business combination, costs related to the proposed business combination, changes in applicable laws or regulations, the possibility that AHAC or Humacyte may be adversely affected by other economic, business, and/or competitive factors, and other risks and uncertainties, including those included under the header “Risk Factors” in the registration statement on Form S-4 filed by AHAC with the SEC and those included under the header “Risk Factors” in the final prospectus of AHAC related to its initial public offering. Most of these factors are outside of AHAC’s and Humacyte’s control and are difficult to predict. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. The forward-looking statements in this press release represent our views as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.

Non-Solicitation

This press release is not a proxy statement or solicitation of a proxy, consent or authorization with respect to any securities or in respect of the proposed business combination and shall not constitute an offer to sell or a solicitation of an offer to buy any securities nor shall there be any sale of securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. No offer of securities shall be made except by means of a prospectus meeting the requirements of the Securities Act.

Humacyte Investor Contact:

[email protected]

Humacyte Media Contact:

[email protected]

–On track to report topline data from a clinical study of KB295 in patients with mild-to-moderate ulcerative colitis by end of third quarter–

–Kaleido and the COPD Foundation to collaborate on the development of KB109 in patients with COPD; plan to initiate Phase 2 clinical study in first quarter 2022–

–Additional data from an observational clinical study of KB109 in patients with mild-to-moderate COVID-19 expected by end of third quarter–

LEXINGTON, Mass., Aug. 11, 2021 (GLOBE NEWSWIRE) — Kaleido Biosciences, Inc. (Nasdaq: KLDO), a clinical-stage healthcare company with a differentiated, chemistry-driven approach to targeting the microbiome to treat disease and improve human health, today reported financial results for the second quarter ended June 30, 2021.

“We have made considerable progress so far this year across our dynamic and diverse clinical pipeline of novel, targeted Microbiome Metabolic Therapy^TM (MMT) candidates. We continue to advance KB295 in patients with mild-to-moderate ulcerative colitis and anticipate reporting topline data from the clinical study by the end of the third quarter,” said Dan Menichella, President and Chief Executive Officer of Kaleido. “This quarter, we also expect to report data from the observational clinical study evaluating COVID-19 symptoms in ‘Long Hauler’ patients that participated in our prior COVID-19 clinical studies.”

Continued Mr. Menichella: “Additionally, we are proud to have announced a strategic collaboration with the COPD Foundation, an organization uniquely qualified to aid us in our mission to improve the lives of patients suffering from COPD. Our KB109 program will be greatly enhanced with support from the COPD Foundation, and we look forward to a productive and mutually beneficial partnership that leverages the strong data from our COVID-19 studies to explore treatment of COPD, the most prevalent chronic respiratory illness, impacting over 250 million people worldwide. While we are prioritizing COPD based on our assessment of the unmet need and commercial opportunity, we will continue to evaluate development opportunities for KB109 in COVID-19 with partners and government agencies.”

Recent Program and Corporate Highlights 

• Topline data from the non-IND clinical study of KB295 in patients with mild-to-moderate ulcerative colitis (UC) are expected by the end of the third quarter.
• Additional data from the observational clinical study of KB109 in patients with mild-to-moderate COVID-19 are expected by the end of the third quarter.
• In August, Kaleido announced a collaboration with the COPD Foundation that is on track to initiate a Phase 2 clinical study of KB109 in patients with chronic obstructive pulmonary disease (COPD) in the first quarter of 2022.

Second Quarter Financial Results

Kaleido reported a net loss of $23.9 million, or $0.56 per common share, for the second quarter of 2021 compared to $18.9 million, or $0.59 per common share, for the same period in 2020. The second quarter net loss includes non-cash stock-based compensation expenses of $2.4 million, as compared to $2.8 million in the second quarter of 2020.

Research and development (R&D) expenses were $17.6 million and $12.8 million for the three months ended June 30, 2021 and 2020, respectively. The increase was primarily due to an increase in production of material for use in our clinical studies.

General and administrative (G&A) expenses were $5.8 million and $5.6 million for the three months ended June 30, 2021 and 2020, respectively. The increase was primarily due to increased facility operating costs that were attributed to general and administrative functions.

As of June 30, 2021, the Company reported cash and cash equivalents of $72.0 million and has cash runway into the second quarter of 2022.

About Microbiome Metabolic Therapies (MMT™)

Kaleido’s Microbiome Metabolic Therapies, or MMTs, are designed to drive the function and distribution of the microbiome’s existing microbes in order to decrease or increase the production of metabolites, or to advantage or disadvantage certain bacteria in the microbiome community. The Company’s initial MMT candidates are targeted, synthetic glycans that are orally administered, have limited systemic exposure, and are selectively metabolized by enzymes in the microbiome. Kaleido utilizes its discovery and development platform to study MMTs in microbiome samples to rapidly advance MMT candidates rapidly into clinical studies in healthy subjects and patients. These human clinical studies are conducted under regulations supporting research with food, evaluating safety, tolerability and potential markers of effect. For MMT candidates that are further developed as therapeutics, the Company conducts clinical trials under an Investigational New Drug (IND) or regulatory equivalent outside the U.S., and in Phase 2 or later development.  

About Kaleido Biosciences

Kaleido Biosciences is a clinical-stage healthcare company with a differentiated, chemistry-driven approach to targeting the microbiome to treat disease and improve human health. The Company has built a proprietary product platform to enable the rapid and cost-efficient discovery and development of novel Microbiome Metabolic Therapies (MMT™). MMTs are designed to modulate the metabolic output and profile of the microbiome by driving the function and distribution of the gut’s existing microbes. Kaleido is advancing a broad pipeline of MMT candidates with the potential to address a variety of diseases and conditions with significant unmet patient needs. To learn more, visit https://kaleido.com/.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the timing of initiation, completion and reporting of results of clinical studies, and our anticipated regulatory filings, strategy, business plans and focus. The use of words such as “may,” “might,” “will,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify such forward-looking statements. All such forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include fluctuations in our stock price, changes in market conditions and satisfaction of customary closing conditions related to the public offering and those risks more fully discussed in the section entitled “Risk Factors” in Kaleido’s annual report on Form 10-K for the fiscal year ended December 31, 2020, which is available at www.sec.gov, as well as discussions of potential risks, uncertainties, and other important factors in Kaleido’s subsequent filings with the Securities and Exchange Commission. Any forward-looking statements represent Kaleido’s views only as of today and should not be relied upon as representing its views as of any subsequent date. All information in this press release is as of the date of the release, and Kaleido undertakes no duty to update this information unless required by law.

Kaleido Biosciences, Inc. and Subsidiaries

Condensed Consolidated Statement of Operations (Unaudited)

(in thousands, except share and per share data)

Kaleido Biosciences, Inc. and Subsidiaries

Condensed Consolidated Balance Sheet Data (Unaudited)

(in thousands)

Contacts:


Kaleido Biosciences


William Duke, Jr.
Chief Financial Officer
617-890-5772
[email protected]

Investors and Media


Kotaro Yoshida
Argot Partners
212-600-1902
[email protected]

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AUSTIN, TX, Aug. 11, 2021 (GLOBE NEWSWIRE) — AYRO, Inc. (Nasdaq: AYRO) (“AYRO” or the “Company”), a designer and manufacturer of purpose-built, short-haul and last-mile delivery electric vehicles (EVs), today announces financial results for its second fiscal second quarter ended June 30, 2021.

Second Quarter 2021 Financial Highlights:

• Revenue of $522,067 (+83% YOY)
• Net Loss Attributable to Common Stockholders of ($7.7) million
• Adjusted EBITDA loss of ($5.9) million
• Total Cash of $87.9 million as of June 30, 2021
• No debt as of June 30, 2021

Recent Corporate Highlights:

• Launched the 2022 Club Car Current (“Current”), the next generation of the Club Car 411 that features a new unique industrial design, enhanced ergonomics, and new options for safety and comfort, in early June 2021
• Announced purchase orders for the Current from Club Car in the first two months following the Current’s launch valued at a total of $4.9 million
• Completed integration and set up, along with inaugural vehicle production, at Karma Automotive, AYRO’s contract manufacturing partner in southern California
• Contracted backlog of $1.8 million as of June 30, 2021

“During the second quarter of 2021, we made significant progress by launching our next-generation commercial utility EV called the Club Car Current in early June. The Current offers additional ergonomic, convenience, and safety features when compared to our first-generation 411 utility truck and specifically targets the campus, stadium, and venue settings, in addition to urban last-mile deliveries,” said CEO Rod Keller. “Furthermore, since its launch, we have announced purchase orders valued at a total of $4.9 million from Club Car for the Current, which is reflective of strong demand for this purpose-built EV. We anticipate additional orders over time from Club Car, as well as from Gallery Carts and Element Fleet Management.

“Despite the growing demand and increased purchase orders, revenue was down slightly from first quarter, mostly due to the Current being launched near the end of the quarter and given that we started manufacturing of the Current at Karma Automotive’s Innovation and Customization Center in California for the first time. Our relationship with Karma allows for a faster shipping and production ramp of the Current. We are pleased with the purchase orders received since the launch and are encouraged about the demand profile for the Current and our and our partners’ ability to meet that commercial demand.

“We are excited about the Current’s launch and its anticipated revenue impact as market needs and demand for urban last-mile delivery continue to expand. AYRO EVs can be found serving food on university campuses, supporting local delivery for restaurants, and moving goods and equipment around government or corporate campuses, hospitals, resorts, stadiums, and airports. As organizations continue to adopt new, innovative ways to move, there’s a clear need for purpose-built, last-mile goods transport that’s zero emission and agile.

“This market is rapidly expanding and, in turn, presents a significant opportunity for our next generation e-delivery vehicle and system that addresses the $45 billion U.S. restaurant delivery market. We are expecting to unveil this new, purpose-engineered e-delivery system later this year and anticipate its official launch in the first half of 2022. The feedback we have received from countless restaurant chains during the design process is assisting our efforts to develop a vehicle that is truly purpose-built for restaurant delivery and that will resonate well with this industry.

“We are optimistic that we can address these ‘last-mile’ challenges with the Club Car Current and new e-delivery system, demonstrating how AYRO EVs are a bridge to the new reality of mobility.

“Our balance sheet remains strong, with nearly $88 million in cash, and we look forward to the initial launch phase of the Current and advancing in the development of the restaurant e-delivery system. Once again, we are thankful for our shareholder support and look forward to sharing additional progress and corporate milestones with investors,” concluded Mr. Keller.

Conference Call Today:

Rod Keller, CEO and Curt Smith, CFO will be conducting a conference call this morning at 8:30 a.m. ET in which they will lead a discussion of second quarter 2021 financial results with a Q&A session to follow. To listen to the conference call, interested parties should dial 1-833-953-2436 (domestic) or 1-412-317-5765 (international). All callers should dial in approximately 10 minutes prior to the scheduled start time and ask to be joined into the AYRO, Inc. conference call.

The conference call will also be available through a live webcast that can be accessed at https://services.choruscall.com/mediaframe/webcast.html?webcastid=VHahxpvO or via the Company’s website at https://ir.ayro.com/news-events/ir-calendar.

The webcast replay will be available until November 11, 2021 and can be accessed through the above links. A telephonic replay will be available until August 25, 2021 by calling 1-877-344-7529 (domestic) or 1-412-317-0088 (international) and using access code 10159382.

About A


YRO,


Inc.

Texas-based AYRO, Inc. engineers and manufactures purpose-built electric vehicles to enable sustainable fleets. With rapid, customizable deployments that meet specific buyer needs, AYRO’s agile EVs are an eco-friendly microdistribution alternative to gasoline vehicles. The AYRO Club Car Current is the only zero-emission, purpose-built EV known to AYRO that can be optimized for the needs of any sustainable fleet. AYRO innovates with speed, discipline, and agility and was founded in 2017 by entrepreneurs, investors, and executives with a passion for creating sustainable urban electric vehicle solutions for micromobility. For more information, visit: www.ayro.com.

Forward-Looking Statements

This press release may contain forward-looking statements. These forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause actual results, performance or achievements to be materially different from any expected future results, performance, or achievements. Words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “may,” “plan,” “project,” “target,” “will,” “would” and their opposites and similar expressions are intended to identify forward-looking statements and include the expected value of the purchase order, the assembly, customization and offering of vehicles by AYRO’s strategic partners and the expected launch of new products. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, without limitation: the ability of AYRO’s suppliers to deliver parts and assemble vehicles; the ability of the purchaser to terminate or reduce purchase orders; AYRO has a history of losses and has never been profitable, and AYRO expects to incur additional losses in the future and may never be profitable; the impact of public health epidemics, including the COVID-19 pandemic; the market for AYRO’s products is developing and may not develop as expected and AYRO, accordingly, may never meet its targeted production and sales goals; AYRO’s business is subject to general economic and market conditions, including trade wars and tariffs; AYRO’s business, results of operations and financial condition may be adversely impacted by public health epidemics, including the recent COVID-19 outbreak; AYRO’s limited operating history makes evaluating its business and future prospects difficult and may increase the risk of any investment in its securities; AYRO may experience lower-than-anticipated market acceptance of its vehicles; developments in alternative technologies or improvements in the internal combustion engine may have a materially adverse effect on the demand for AYRO’s electric vehicles; the markets in which AYRO operates are highly competitive, and AYRO may not be successful in competing in these industries; a significant portion of AYRO’s revenues are derived from a single customer; AYRO relies on and intends to continue to rely on a single third-party supplier in China for the sub-assemblies in semi-knocked-down state for all of its current vehicles; AYRO may become subject to product liability claims, which could harm AYRO’s financial condition and liquidity if AYRO is not able to successfully defend or insure against such claims; the range of our electric vehicles on a single charge

declines over time, which may negatively influence potential customers’ decisions whether to purchase AYRO’s vehicles; increases in costs, disruption of supply or shortage of raw materials, in particular lithium-ion cells, could harm AYRO’s business; AYRO may be required to raise additional capital to fund its operations, and such capital raising may be costly or difficult to obtain and could dilute AYRO stockholders’ ownership interests, and AYRO’s long term capital requirements are subject to numerous risks; AYRO may fail to comply with environmental and safety laws and regulations; and AYRO is subject to governmental export and import controls that could impair AYRO’s ability to compete in international market due to licensing requirements and subject AYRO to liability if AYRO is not in compliance with applicable laws. A discussion of these and other factors is set forth in our most recent Annual Report on Form 10-K and subsequent reports on Form 10-Q. Forward-looking statements speak only as of the date they are made and AYRO disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

AYRO, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

AYRO, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(UNAUDITED)

AYRO, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF CASH FLOWS

(UNAUDITED)

Non-GAAP Financial Measures

We present Adjusted EBITDA because we consider it to be an important supplemental measure of our operating performance, and we believe it may be used by certain investors as a measure of our operating performance. Adjusted EBITDA is defined as income (loss) from operations before interest income and expense, income taxes, depreciation, amortization of intangible assets, amortization of discount on debt, impairment of long-lived assets, stock-based compensation expense and certain non-recurring expenses.

Adjusted EBITDA is not a measurement of financial performance under generally accepted accounting principles in the United States, or GAAP. Because of varying available valuation methodologies, subjective assumptions and the variety of equity instruments that can impact our non-cash operating expenses, we believe that providing a non-GAAP financial measure that excludes non-cash and non-recurring expenses allows for meaningful comparisons between our core business operating results and those of other companies, as well as providing us with an important tool for financial and operational decision making and for evaluating our own core business operating results over different periods of time.

Adjusted EBITDA may not provide information that is directly comparable to that provided by other companies in our industry, as other companies in our industry may calculate non-GAAP financial results differently, particularly related to non-recurring, unusual items. Adjusted EBITDA is not a measurement of financial performance under GAAP and should not be considered as an alternative to operating income or as an indication of operating performance or any other measure of performance derived in accordance with GAAP. We do not consider Adjusted EBITDA to be a substitute for, or superior to, the information provided by GAAP financial results.

Below is a reconciliation of Adjusted EBITDA to net loss for the three months ended June 30, 2021 and 2020: