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Item 7. Management’s Discussion and Analysis

2023-03-15 compared with 2022-03-22 · 148 added, 242 removed, 284 unchanged (58% of the section changed)

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Factors that could cause or contribute to such differences include, but are not limited to, those discussed in the section of this Annual Report on Form 10-K titled “Risk factors.” Please also see the section titled “Special note regarding forward-looking statements.”

We are a leading commercial cell engineering company focused on providing enabling platform technologies to advance innovative cell-based research as well as next-generation cell therapeutic discovery, development and commercialization.

Over the past twenty years, we have developed and commercialized our proprietary Flow Electroporation platform, which facilitates complex engineering of a wide variety of cells.

We are a leading commercial cell engineering company focused on providing enabling platform technologies to advance the discovery, development and commercialization of next-generation cell therapeutics and to support innovative cell-based research and development.

Over more than two decades, we have developed and commercialized our proprietary Flow Electroporation platform, which facilitates complex engineering of a wide variety of cells.

Electroporation is a method of transfection, or the process of deliberately introducing molecules into cells, that involves applying an electric field in order to temporarily increase the permeability of the cell membrane.

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Our ExPERT platform, which is based on our Flow Electroporation technology, has been designed to address this rapidly expanding cell therapy market and can be utilized across the continuum of the high-growth cell therapy sector, from discovery and development through commercialization of next-generation, cell-based medicines.

The ExPERT family of products includes:

three instruments, which we call the ATx, STx and GTx, respectively and related software protocols, as well as a portfolio of proprietary related disposables and consumables (as well as the VLx instrument for very large-scale cell engineering made available for sale in December 2021).

These include processing assemblies, or PAs, designed for use with our instruments, as well as accessories supporting PAs such as electroporation buffer solution and software protocols.

The ExPERT family of products includes four instruments, which we call the ATx, STx, GTx and VLx, and related software protocols, as well as a portfolio of proprietary related disposables and consumables.

We launched the VLx instrument in September 2022.

Our disposables and consumables include PAs designed for use with our instruments, as well as accessories supporting PAs such as electroporation buffer solution and software protocols.

We have garnered meaningful expertise in cell engineering via our internal research and development efforts as well as our customer-focused commercial approach, which includes a growing application scientist team.

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and foreign patents and more than 95 pending patent applications worldwide.

From leading commercial cell therapy drug developers and top biopharmaceutical companies to top academic and government research institutions, including the U.S.

National Institutes of Health, or NIH, our customers have extensively validated our technology.

From leading commercial cell therapy drug developers and top biopharmaceutical companies to top academic and government research institutions, including the NIH, our customers have extensively validated our technology.

We believe the features and performance of our platform have led to sustained customer engagement.

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As of December 31, 2022, we have placed more than 600 of our electroporation instruments worldwide.

We have financed our operations primarily from the issuance and sale of equity securities, previous debt borrowings and cash flows from operations.

Our registration statement on Form S-1 related to our initial public offering of common stock in the United States was declared effective on July 29, 2021, and our common stock began trading on the Nasdaq Global Select Market on July 30, 2021.

On August 3, 2021, we issued and sold 15,525,000 shares of common stock in the IPO at a price to the public of $13.00 per share, inclusive of 2,025,000 shares issued pursuant to the full exercise of the underwriters’ option to purchase additional shares.

Historically, we have financed our operations primarily from the issuance and sale of equity securities, previous debt borrowings and cash flows from operations.

On August 3, 2021, we issued and sold 15,525,000 shares of common stock in our U.S.

IPO at a price to the public of $13.00 per share, inclusive of 2,025,000 shares issued pursuant to the full exercise of the underwriters’ option to purchase additional shares.

The IPO generated gross proceeds to us of $201.8 million.

We received aggregate net proceeds of $184.3 million after deducting aggregate underwriting commissions and offering costs of $17.6 million.

We believe that the net proceeds from the IPO, together with our existing cash, will enable us to fund our operating expenses and capital expenditure requirements for the foreseeable future.

We believe that our current cash, cash equivalents and short-term investments will enable us to fund our operating expenses and capital expenditure requirements for the foreseeable future.

We have based this estimate on assumptions that may prove to be wrong, however, and we could exhaust our available capital resources sooner than we expect.

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Our ability to generate revenue sufficient to achieve profitability will depend on the successful further development and commercialization of our products.

We generated revenue of $33.9 million, $26.2 million and $21.6 million for the years ended December 31, 2021, 2020 and 2019, respectively, and incurred net losses of $19.1 million, $11.8 million and $12.9 million for those same years.

We generated revenue of $44.3 million and $33.9 million for the years ended December 31, 2022 and 2021, respectively, and incurred net losses of $23.6 million and $19.1 million for those same years.

As of December 31, 2022, we had an accumulated deficit of $137.9 million.

We expect to continue to incur net losses as we focus on growing commercial sales of our products in both the United States and international markets, including growing our sales teams, scaling our manufacturing operations, continuing research and development efforts to develop new products and further enhance our existing products.

Further, we expect to incur additional costs associated with operating as a public company in the United States.

We believe we have a diversified revenue model with revenue generated from multiple sources including instrument leases with recurring license fees, sales of instruments and related disposables and participation in the clinical and commercial success of some of our customers through milestone and sales-based payments under agreements that we refer to as Strategic Platform Licenses, or SPLs.

In addition to our ExPERT products, we previously developed CARMA, a proprietary therapeutic platform based on transfecting mRNA into unstimulated cells for the development of immune cell therapies.

In the first quarter of 2021, we conducted a strategic review of our CARMA activities and made the decision to cease further research and clinical development activities with respect to the CARMA platform for our own internal purposes and instead focus on out-licensing the CARMA platform manufacturing processes and associated intellectual property to third-party customers.

During the years ended December 31, 2021, 2020 and 2019, our CARMA-related expenses were $4.1 million, $11.1 million and $11.7 million, respectively.

As a result of our strategic decision to focus on out-licensing this platform, we will no longer incur these expenses in future periods.

Impact of COVID-19 on Our Business

We continue to closely monitor the impact of the novel coronavirus, or COVID-19, pandemic on our business and the geographic regions where we operate.

The impact of this pandemic has been and will likely continue to be extensive in many aspects of society, which has resulted in and will likely continue to result in significant disruptions to the global economy, as well as businesses and capital markets around the world.

Impacts to our business as a result of COVID-19 have included disruptions to our manufacturing operations and supply chain caused by facility closures, reductions in operating hours, staggered shifts and other social distancing efforts, decreased productivity and unavailability of materials or components, limitations on our employees’ and customers’ ability to travel, and delays in product installations, demonstrations, trainings or shipments to and from affected countries and within the United States.

In light of the uncertain and rapidly evolving situation relating to the spread of COVID-19, we have taken precautionary measures intended to minimize the risk of the virus to our employees, our customers and the communities in which we operate, including temporarily closing our offices to visitors and limiting the number of employees in our offices to those that are deemed essential for manufacturing and research purposes, as well as virtualizing, postponing or canceling customer, employee and industry events.

Disruptions in our customers’ operations have impacted and may continue to impact our business.

For example, customers have experienced delays in the progress of their clinical programs, shutdowns or slowdowns in their research laboratory operations, cessation of equipment purchases, and closing of their facilities to outsiders, which have disrupted our ability to conduct product demonstrations that are a key part of our selling process.

We are focused on navigating the challenges presented by the COVID-19 pandemic, which includes increased focus on inventory levels of finished goods and parts to reduce the risk of COVID-19 related supply constraints.

We do not yet know the net impact that the COVID-19 pandemic may have on our business and cannot guarantee that it will not be materially negative.

Although we continue to monitor the situation and may adjust our current policies as more information and public health guidance become available, the ongoing effects of the COVID-19 pandemic and/or the precautionary measures that we or our customers have implemented or may adopt may create operational and other challenges, any of which could harm our business and results of operations.

While we maintain an inventory of finished products and raw materials used in our products, a prolonged pandemic could lead to shortages and/or extended lead times for the raw materials necessary to manufacture our products.

If we experience a prolonged disruption in our manufacturing, supply chains or commercial operations, or if demand for our products is significantly reduced as a result

of the COVID-19 pandemic, we would expect to experience a material adverse impact on our business, financial condition, results of operations and prospects.

Historically, a significant portion of our field sales, product demonstrations and user support have been conducted in person, and the marketing of our products, sourcing of potential new customers and rollout of our new products has historically been supported by our participation at industry conferences.

Currently, as a result of the work and travel restrictions related to the COVID-19 pandemic, and the precautionary measures that we have adopted, substantially all of our field sales and professional services activities are being conducted remotely, which has resulted in a decrease in our travel and conference-related marketing expenditures.

However, we expect these expenditures to increase in the future, which could negatively impact our financial condition and results of operations.

As of the date of this Annual Report on Form 10-K, we do not yet know the extent of the negative impact of such restrictions and precautionary measures on our ability to attract new customers or retain and expand our relationships with existing customers over the near and long term.

Key Factors Affecting Our Performance

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Our financial performance has largely been driven by, and in the future will continue to be impacted by, the rate of sales and leases of our ExPERT family of proprietary Flow Electroporation instruments to existing and new customers.

We currently market three versions of our instruments, the ATx, the STx, and the GTx, and we introduced a fourth version called the VLx under the EXPERT brand in December 2021.

We currently market four versions of our instruments, the ATx, the STx, the GTx and the VLx.

The ATx is primarily sold in all our markets.

The STx is primarily sold to end users for research and drug discovery purposes, and the GTx is leased to customers for research, clinical or commercial use or sold for research use in certain circumstances or sold to academic centers for research or clinical use.

We launched the VLx in September 2022 to provide our customers with an easier to use system that incorporates the benefits of the ExPERT platform.

We view the demand for our instruments, whether in the form of sales or leases, as an indicator of the health of our current business and as a predictor of future instrument sale and lease revenue.

As described below, we separately sell proprietary single-use disposables, which we call processing assemblies, or PAs, that are necessary for our customers to use our electroporation instruments.

As described below, we separately sell proprietary single-use disposables, which we call PAs, that are necessary for our customers to use our electroporation instruments.

Therefore, depending on the number of instruments that have been sold or are under active lease, we have insight into the demand for PAs that will also translate to future revenue for us.

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If our customer intends to use our platform for research or drug discovery only, we typically sell the instrument outright.

Each of the ATx, STx and GTx instruments have different prices based on the instrument’s features, with the GTx being the most expensive.

Each of the ATx, STx, GTx and VLx instruments have different prices based on the instrument’s features, with the VLx being the most expensive.

When we sell an instrument, we also provide a non-exclusive license to our intellectual property for the customer to use the instrument broadly for research or drug discovery, as applicable.

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For cell therapy customers who use our technology to develop engineered cells for human therapeutic use in clinical trials or, if approved by regulatory authorities, for commercial sale, we license our platform on a non-exclusive basis in exchange for an annual fee per instrument licensed.

This license fee varies based on whether the instrument is being used for pre-clinical or clinical purposes.

Once we have leased an instrument to a customer, we generally have high visibility

into future lease revenue from this customer.

This license fee varies based on whether the instrument is being used for preclinical or clinical purposes.

Once we have leased an instrument to a customer, we generally have high visibility into future lease revenue from this customer.

It is possible, however, that our future lease revenue could be impacted by failure of the customer therapeutic candidates to progress through clinical development for reasons unrelated to the successful use of our instruments, such as drug toxicity, lack of efficacy, funding constraints, changes in development priorities, patient access limitations or regulatory challenges.

For any of these reasons, a customer could determine not to renew or to enter into additional instrument leases with us.

Our installed base of electroporation instruments has grown from over 125 instruments as of December 31, 2015, to over 500 instruments as of December 31, 2021.

Our installed base of electroporation instruments has grown to over 600 instruments as of December 31, 2022.

This installed base includes both instruments sold to customers and instruments licensed for research and clinical use.

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In addition to instrument sales, our current and future revenue is dependent on sales of our proprietary PAs, as well as the sale of our proprietary electroporation buffer solution, for use with our instruments.

We sell PAs that are intended either to support research use or use in current good manufacturing practices, or cGMP, clinical research applications.

We sell PAs that are intended either to support research use or use in cGMP clinical research applications.

The PAs differ in terms of their volume capacities and the associated numbers of cells that can be processed in each electroporation sequence with a particular PA, as well as the number of transfection experiments that can be performed in a single electroporation process.

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However, both the number of PAs used per instrument, as well as the specific PA used, is highly variable across our customer base and depends on several factors, including:

• Purpose for which the customer is using the platform;

• Relative pricing of our PAs;

• Progression of cell therapy products through preclinical and clinical development;

• the purpose for which the customer is using the platform;

• the relative pricing of our PAs;

• the progression of cell therapy products through preclinical and clinical development;

• whether the cell therapy customer uses a centralized or decentralized manufacturing process;

• Customer’s target indication, which can result in variations in patient numbers needed for clinical trials;

• the customer’s target indication, which can result in variations in patient numbers needed for clinical trials;

• whether the cells to be processed using our platform are patient-derived, donor-derived or cell line-derived.

With considerable variability of processes, even within the same indication, such as is the case for allogeneic genetically-modified cell therapies, such as chimeric antigen receptor T cells, or CAR-Ts, and the nascency of the cell therapy industry, we expect that it may take several years for us to gain visibility into how these factors will impact our PA revenue over time.

We continuously re-evaluate our PA portfolio based on customer needs and have introduced, and intend to continue to introduce, new PAs and improvements to existing PAs.

Beginning in 2019, we have launched a series of new PAs including the R-1000, which can process up to 1 mL, or 200 million cells, and the R-50x3, which is a 3-well cuvette capable of processing up to 10 million cells in each well.

In 2021, we expanded our portfolio of multi-well cuvettes, which reduce manual handling and improve productivity in the lab, with the launch of our R-50x8.

The R-50x8 is an 8-well cuvette capable of processing up to 225,000 cells in each well.

Compared to single-well PAs, multi-well PAs allow users to run multiple samples concurrently, which enables scientists to complete more experiments per run, leading to shorter overall processing time and lower per transfection cost.

The introduction of new PAs, however, introduces additional uncertainty.

With considerable variability of processes, even within the same indication, such as is the case for allogeneic genetically-modified cell therapies, such as CAR-Ts and the nascency of the cell therapy industry, we expect that it may take several years for us to gain visibility into how these factors will impact our PA revenue over time.

We continuously re-evaluate our PA portfolio based on customer needs and have introduced, and intend to continue to introduce, new PAs, improvements to existing PAs, and complementary products.

Some new PAs may fail to be used in line with our expectations when they are launched.

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Strategic Platform Licenses (SPLs)

Typically, our cell therapy customers will either purchase our ATx instrument for research purposes or obtain a research use license under lease of our GTx instrument technology in order to validate the use of our technology in their programs and to progress their pre-clinical work towards clinic trials.

However, once a cell therapy customer using one of our ExPERT instruments advances their pre-clinical research to a stage where they are planning to enter clinical development, they need to enter into a licensing arrangement with us for the rights to clinical and/or commercial use of our instrument.

Our customers typically negotiate the terms of those licenses during research and pre-clinical development.

We refer to these arrangements as SPLs, the terms of which contain not only higher annual, non-exclusive license fees for the clinical use of the instrument, but also allow us to share in the economics of the customer’s programs.

From 2017 through February 2022, we have entered into 16 SPLs with commercial cell therapy developers, and those licenses currently allow for over 95 clinical development programs in the aggregate.

On average, our current SPLs allow for approximately six product candidates per license, although this average may change over time.

SPLs include potential payments to us upon the customer’s achievement of specified clinical development or regulatory milestones, as well as potential sales-based payments to us, which could be payments based upon the achievement of specified sales levels and/or royalty payments that are a percentage of the customer’s net sales.

The amount of each milestone payment is typically correlated in size with value-creating, pre-commercial clinical progress events or commercial sales levels.

Of the over 95 programs associated with our current SPLs, more than 15% are in the clinic, meaning they have at least an FDA-cleared Investigational New Drug application, or IND.

Our 16 SPLs have the potential to generate over $1.25 billion in pre-commercial milestone payments, if all product candidates allowed under those agreements were to fully progress through clinical development and obtain regulatory approval.

However, our actual milestone revenue from these agreements will likely be considerably lower than this amount, as not all programs covered by each agreement will become and remain active programs in a customer’s development pipeline or successfully complete the clinical

development process.

Typically, our cell therapy customers will either purchase our ATx instrument for research purposes or purchase or obtain a research use license under lease of our GTx instrument technology in order to validate the use of our technology in their programs and to progress their preclinical work towards clinic trials.

However, once a cell therapy customer using one of our ExPERT instruments advances their preclinical research to a stage where they are planning to enter clinical development, they need to enter into a licensing arrangement with us for the rights to clinical and/or commercial use of our instrument.

Our customers typically negotiate the terms of those licenses during research and preclinical development.

We refer to these arrangements as SPL partnerships, the terms of which contain not only higher annual, non-exclusive license fees for the clinical use of the instrument, but also allow us to share in the economics of the customer’s programs.

From 2017 through February 2023, we have entered into 19 SPL partnerships with commercial cell therapy developers, and those licenses currently allow for over 125 clinical development programs in the aggregate.

On average, our current SPL partnerships allow for approximately six product candidates per license, although this average may change over time.

SPL partnerships typically include potential payments to us upon the customer’s achievement of specified clinical development or regulatory milestones, as well as potential sales-based payments to us, which could be payments based upon the achievement of specified sales levels and/or royalty payments that are a percentage of the customer’s net sales.

The amount of each milestone payment is typically correlated in size with value-creating, precommercial clinical progress events or commercial sales levels.

Of the over 125 programs associated with our current SPLs, 16 of those programs are currently active in the clinic, meaning they have at least an FDA-cleared IND.

Our 19 SPLs have the potential to generate over $1.55 billion in precommercial milestone payments, if all product candidates allowed under those agreements were to fully progress through clinical development and obtain regulatory approval.

Further, each agreement typically includes programs that have not been specifically identified, or for which a candidate may never be identified or developed by the customer.

Our strategy is to capitalize on the growth in the number of cell therapy developers by entering into new SPLs.

We announced six such agreements in 2019, three in 2020, four in 2021 and one so far in 2022.

For the year ended December 31, 2021, one cell therapy company with which we have entered into an SPL accounted for 21% of our total revenue, and our six largest such customers accounted for an aggregate of approximately 40% of our total revenue for the year through a combination of instrument license fees, milestones realized and processing assembly revenue.

Our future milestone revenue under our SPLs will depend in large part on the clinical and regulatory achievements of our customers.

Generally, pre-commercial milestone payments become larger as programs move through the clinic.

We rely in part on our customers’ public disclosures around regulatory timelines to forecast our receipt of pre-commercial milestone payments.

While we expect our forecasting ability to improve over time as more of our customers’ programs advance through the clinic and the number of clinical programs covered by our licenses expands, given the early nature of the cell therapy clinical market, we expect our realization of pre-commercial milestones to be somewhat unpredictable.

Our strategy is to capitalize on the growth in the number of cell therapy developers by entering into new SPL partnerships.

We entered into three agreements in 2022 and one so far in 2023.

For the year ended December 31, 2022, one cell therapy company with which we have entered into an SPL accounted for 23% of our total revenue, and our six largest SPL partners accounted for an aggregate of approximately 40% of our total revenue for the year through a combination of instrument license fees, milestones realized and processing assembly revenue.

Our future milestone revenue under our SPL partnerships will depend in large part on the clinical and regulatory achievements of our customers.

Generally, precommercial milestone payments become larger as programs move through the clinic.

We rely in part on our customers’ public disclosures around regulatory timelines to forecast our receipt of precommercial milestone payments.

While we expect our forecasting ability to improve over time as more of our customers’ programs advance through the clinic and the number of clinical programs covered by our licenses expands, given the early nature of the cell therapy clinical market, we expect our realization of precommercial milestones to be somewhat unpredictable.

In addition, the potential for sales-based payments once a customer’s product is approved and in commercial use is unknown and variable based on a number of factors, including inherent clinical risk, potential changes in the customer’s strategy, the designated indication and its impact on the potential number of patients to be served and the competitive products available to patients, product pricing and reimbursement structures, our customer’s commercial manufacturing plans and the inherent unknowns in adoption of next-generation cell therapies relative to other modalities.

Gross Margins

We have historically generated overall gross margins of approximately 90% over the past several years, although our margins depend on our revenue mix from instruments, PAs and potential milestones under SPLs.

We have generated overall gross margins of near 90% for the past several years, although our margins vary depending on our revenue mix from instruments, PAs and milestones under SPL partnerships and other factors.

We price our instruments at a premium given what we believe to be the broad benefits of our platform, and the limited availability of alternative, clinically validated non-viral delivery approaches.

However, the market for non-viral delivery is highly competitive, and introduction of a GMP-grade platform by a competitor that delivers similar performance across a similar diversity of cell types could negatively impact our business and lead to increased price pressure that negatively impacts our gross margins.

In addition, part of our growth strategy is to expand into new regional markets, which could require the use of distributors and/or our participation in more competitive environments, which could impact our ability to price our instruments at a premium and could negatively impact our ability to enter into SPLs on terms similar to those currently in effect.

We expect our gross margins to benefit from realization of the economics from our SPL agreements described above, to the extent that such milestones grow to be a significant proportion of overall revenues, as there is no cost of goods sold associated with such revenue.

However, realization of these potential milestone revenues is uncertain.

Margins may experience downward pressure during ramp up of internal PA production or due to increases in labor and materials costs or expansion of our PA portfolio or as a result of future design changes and may benefit in the mid-to-long term as PA production becomes more automated.

We expect our gross margins to benefit from realization of the economics from our SPL partnership agreements described above, to the extent that such milestones and/or sales-based payments grow to be a significant proportion of overall revenues, as there is no cost of goods sold associated with such revenue.

However, realization of these potential revenues is uncertain.

Margins may also experience downward pressure during the investment phase of our internal PA production ramp up, increases in labor and materials costs, expansion of our PA portfolio, future design changes or the mix of PAs sold, or other factors, but may benefit in the mid-to-long term as PA production becomes more automated.

Key Business Metrics

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These key metrics include:

• The number of cumulative instruments that we have placed with our customers, either by sale or lease, which we refer to as our installed base and consider to be an indication of our traction within the non-viral delivery

market and indicative of the future recurring revenue generated from those instruments, including disposables and annual license fees;

• The number of active (customers with rights to develop one or more clinical programs) SPLs that we have entered into with cell therapy developers, as well as the total number of our customers’ clinical programs, whether active or contemplated, that are covered by such active SPLs and the percentage of those clinical programs that are under an active IND application (or foreign equivalent), meaning that the customer is cleared to commence clinical trials;

• The aggregate potential pre-commercial milestone payments under active SPLs, representing the maximum potential milestone payments to us if all programs covered by each SPL were to achieve regulatory approval;

• The aggregate number of potential programs licensed for clinical use, whether active or contemplated, that are covered by our SPLs;

• The aggregate number of programs licensed for clinical use and covered by our SPLs that are currently in the clinic.

• the number of cumulative instruments that we have placed with our customers, either by sale or lease, which we refer to as our installed base and consider to be an indication of our traction within the non-viral delivery market and other markets and indicative of the potential future recurring revenue generated from those instruments, including disposables and annual license fees;

• the number of active (customers with rights to develop one or more clinical programs) SPL partnerships that we have entered into with cell therapy developers, as well as the total number of our customers’ clinical programs, whether active or contemplated, that are covered by such active SPL partnerships and the percentage of those

clinical programs that are under an active IND application (or foreign equivalent), meaning that the customer is cleared to commence clinical trials;

• the aggregate potential precommercial milestone payments under active SPL partnerships, representing the maximum potential milestone payments to us if all programs covered by each SPL partnership were to achieve regulatory approval;

• the aggregate number of potential programs licensed for clinical use, whether active or contemplated, that are covered by our SPL partnerships;

• the aggregate number of programs licensed for clinical use and covered by our SPL partnerships that are currently in the clinic.

With respect to the numbers of programs under license, in many cases we make estimates of such programs based on our contract terms with our customers and our knowledge about our customers’ clinical progression of their programs.

We rely, in part, on our customers’ public disclosures around regulatory timelines to forecast our receipt of pre-commercial milestone payments.

We rely, in part, on our customers’ public disclosures around regulatory timelines to forecast our receipt of precommercial milestone payments.

However, it is possible that some programs may have become dormant or inactive without our knowledge, some new programs may be identified and some programs may progress further in clinical development without our knowledge if the customer has not made a public announcement.

While we expect our forecasting ability to improve over time as more of our customers’ programs move through the clinic and the number of clinical programs covered by our licenses expands, given the early nature of the cell therapy clinical market, we expect our realization of pre-commercial milestones to be somewhat unpredictable.

While we expect our forecasting ability to improve over time as more of our customers’ programs move through the clinic and the number of clinical programs covered by our licenses expands, given the early nature of the cell therapy clinical market, we expect our realization of precommercial milestones to be somewhat unpredictable.

This number may fluctuate due to the success of our commercial partners.

Additionally, the addition of a large multi-product (program) SPL may dilute the percentage of commercial programs currently in the clinic.

Additionally, the addition of a large multi-product (program) SPL partnership may dilute the percentage of commercial programs currently in the clinic.

As of the dates presented, our key metrics described above were as follows:

As of December 31,

Installed base of instruments (sold or leased)

Number of active SPLs

Total number of licensed clinical programs (SPLs only)

Total number of licensed clinical programs under SPLs currently in the clinic **

Total potential pre-commercial milestones under SPLs

Number of active SPL partnerships

Total number of licensed clinical programs (SPL partnerships only)

Total number of active licensed clinical programs under SPL partnerships currently in the clinic **

Total potential precommercial milestones under SPL partnerships

>$1.55 billion

>$950 million

>$1.25 billion

>$950 million

* Amounts presented as of December 31, 2020, give effect to one SPL entered into and additional INDs cleared in January 2021.

** Number of licensed clinical programs under SPLs are by number of product candidates and not by indication.

* Amounts presented as of December 31, 2020 give effect to one SPL partnership entered into and additional INDs cleared in January 2021.

** Number of licensed clinical programs under SPL partnerships are by number of product candidates and not by indication.

Components of Our Results of Operations

We generate revenue principally from the sale of instruments, single-use PAs and buffer as well as from the lease of instruments to our customers.

Our SPLs also include associated clinical progress milestones and sales-based payments to us, in addition to annual lease payments.

Our SPL partnerships also include associated clinical progress milestones and sales-based payments to us, in addition to annual lease payments.

Sales of instruments and disposables under contracts with customers are classified as product sales in our consolidated financial statements.

Revenue from instrument leases, including payments that we may receive from our customers based on their achievement of specified clinical development or commercialization milestones, are classified as leased elements in our consolidated financial statements.

Our business and revenue growth strategy consists of the sale or lease of instruments and the sale of disposables.

Our business and revenue growth strategy currently consists of the sale or lease of instruments and the sale of disposables.

We record revenue from the sale of instruments or PAs upon shipment to a customer.

Instrument leases are typically invoiced annually at the start of each instrument license period and are accounted for as monthly revenue over the lease term with the expectation of continuing customer renewals of their instrument leases.

Instrument leases are

typically invoiced annually at the start of each instrument license period and are accounted for as monthly revenue over the lease term with the expectation of continuing customer renewals of their instrument leases.

As our customers achieve clinical progress milestones and/or sales-based payment milestones, we recognize the full value of the milestone as revenue.

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We consider these sales and lease revenue streams to be recurring revenues.

In order to evaluate how our sales are trending across key markets, as well as the contribution of program economics from our SPLs, we separately analyze revenue derived from our cell therapy customers and drug discovery customers, as well as the performance-based milestone revenues we recognize under our SPLs.

In order to evaluate how our sales are trending across key markets, as well as the contribution of program economics from our SPL partnerships, we separately analyze revenue derived from our cell therapy customers and drug discovery customers, as well as the performance-based milestone revenues we recognize under our SPL partnerships.

Cell therapy includes revenue from instruments sold, annual license fees for instruments under lease, and sales of our proprietary disposables.

Drug discovery includes revenue from instruments sold, sales of our proprietary disposables and, occasionally, instruments leased, in each case under contracts with drug discovery customers.

Program-related revenue includes pre-commercial milestones earned and recognized as revenue during the period.

Program-related revenue includes precommercial milestones earned and recognized as revenue during the period.

Once SPL customers achieve regulatory approval for and commercialize their products, in nearly all cases we will also be entitled to receive sales-based payments which may be milestone payments upon achievement of specified levels of net sales and/or royalties expressed as a percentage of net sales.

We have not received any commercial payments from our SPL customers to date, and we do not expect to receive any such payments in the near term.

We have not received any commercial payments from our SPL customers to date.

As our customers progress their programs and achieve additional milestones, our SPL program revenue is expected to constitute a growing portion of our total revenues in future periods.

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Our extended warranty and service plans are offered for periods beyond the standard no-fee, one-year warranty that customers who purchase instruments receive.

These extended warranty and service plans generally have fixed fees and terms ranging from one additional year to four additional years and include an annual calibration.

Leases of instruments include warranty during the lease term without additional charge.

Extended warranty and service plans generally have fixed fees and terms ranging from one additional year to four additional years and include an annual calibration.

We recognize revenue from the sale of extended warranty and service plans over the respective coverage period, which approximates the service effort provided by us.

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Revenue from contracts with customers includes revenue from the sale of instruments, PAs and buffer.

Customers purchase an ATx, STx or GTx depending upon their intended use and all customers purchase PAs for use with our instruments.

Customers purchase an ATx, STx, GTx or VLx depending upon their intended use and all customers purchase PAs for use with our instruments.

Commercial customers may not use a purchased instrument for clinical or commercial processes.

We expect product sales revenue to increase in future periods as our market grows and we are able to generate recurring PA sales.

We expect product sales revenue to increase in future periods as our market and customer base grow.

Leased Elements

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Typically, instrument leases that provide for clinical or commercial use also include sales-based milestone payments (and/or sales-based royalties in some cases) upon the commercialization of the customer's product.

Under our instrument lease arrangements, we lease our instruments to customers and provide associated software licenses to allow customers non-exclusive use of our technology for research and/or specific clinical programs, typically along with rights for commercial use upon approval of the customer's products.

We also provide scientific and regulatory support to our clinical use licensees to help them improve process optimization and facilitate their regulatory submission process.

We expect leased elements revenue to increase in future periods as our market grows.

We expect leased elements revenue to increase in future periods as our market and customer base grow.

Cost of Goods Sold

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Gross profit is calculated as revenue less cost of goods sold.

Gross profit margin is gross profit expressed as a percentage of revenue.

Our gross profit in future periods will depend on a variety of factors, including sales mix among instruments, disposables and milestones, the specific mix among types of instruments or disposables, the proportion of revenues associated with instrument leases as opposed to sales, the share of revenues composed of milestones, changes in the costs to produce our various products, the launch of new products or changes in existing products, our cost structure for manufacturing including changes in production volumes, and the pricing of our products which may be impacted by market conditions.

Gross margin is gross profit expressed as a percentage of revenue.

Our gross profit in future periods will depend on a variety of factors, including sales mix among instruments, disposables and milestones, the specific mix among types of instruments or disposables, the proportion of revenues associated with instrument leases as opposed to sales, the share of revenues composed of milestones, changes in the costs to produce our various products, the launch of new products or changes in existing products, our cost structure for manufacturing including changes in production volumes, the proportion of sales made through third-party distributors, and the pricing of our products which may be impacted by market conditions.

Operating Expenses

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We expense research and development costs as incurred in the period in which the underlying activity is undertaken.

We previously developed CARMA, our proprietary platform technology for the development of non-viral, human messenger RNA, or mRNA-based, chimeric antigen receptor, or CAR, or T-cell receptor, or TCR, redirected immune cell therapies.

In the first quarter of 2021, we conducted a strategic review of our CARMA activities and made the decision to cease further pre-clinical and clinical activities with respect to the CARMA platform and associated candidates (MCY-M11 and other identified targets) for our own internal purposes and instead to focus on out-licensing the CARMA platform manufacturing processes and associated intellectual property to third-party customers.

We previously developed CARMA, our proprietary platform technology for the development of non-viral, mRNA-based, CAR, or TCR redirected immune cell therapies.

In the first quarter of 2021, we conducted a strategic review of our CARMA activities and made the decision to cease further preclinical and clinical activities with respect to the CARMA platform and associated candidates (MCY-M11 and other identified targets) for our own internal purposes and instead to focus on out-licensing the CARMA platform manufacturing processes and associated intellectual property to third-party customers.

For periods through the first half of 2021, our research and development expenses include costs associated with developing the CARMA platform principally for a clinical trial that has concluded.

There were no material CARMA-related expenses in the second half of 2021.

As a result of our strategic decision to focus on out-licensing this platform, we will no longer incur any material CARMA-related expenses in future periods.

There were no material CARMA-related expenses after the first half of 2021.

We believe that our continued investment in research and development is essential to our long-term competitive position.

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Interest expense consists primarily of interest related to borrowings under credit facility agreements.

For the years ended December 31, 2019 and 2020, we had a $5.0 million outstanding term loan, or the Term Loan, under the MidCap Credit Agreement (as discussed further below).

In March 2021, we repaid the Term Loan in full prior to maturity as allowed by and in accordance with the terms of the MidCap Credit Agreement.

We previously had a $5.0 million term loan (the “Term Loan”).

In March 2021, we repaid the Term Loan in full.

Other Income (Expense), Net

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We have recorded a full valuation allowance against our net deferred tax assets at each balance sheet date since, due to our history of net losses, we have determined that it is not currently more likely than not that our net deferred tax assets are recoverable.

The use of our net operating loss carryforwards may have been restricted by changes in our ownership and may be further restricted as a result of future changes in our ownership.

Results of Operations

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Our overall increase in revenue was primarily driven by growth in sales and licenses of instruments and sales of disposables to cell therapy customers.

In the cell therapy market, revenue from instrument sales and licenses of instruments increased by $5.0 million, which was primarily due to continued high levels of capital invested in companies operating in our target markets, while disposables sales increased by $2.1 million as a result of the continued progression of our cell therapy partners’ clinical development programs.

In the drug discovery market, the $1.3 million increase was due to an increase in sales of disposables, including both single-well and multi-well processing assemblies.

The $0.7 million decrease in program-related revenues resulted from expected variability from period to period in the level of program-related revenue given the small number of individual triggering events which currently generate this portion of revenue.

We expect program-related revenue to experience variability for some time, although we anticipate that variability may moderate as the volume of SPLs and associated milestones grows.

In the cell therapy market, revenue from instrument sales and licenses of instruments increased by $4.0 million, which was primarily due to growth in the number of cell therapy customers, particularly SPL partners, as well as continued high levels of capital invested in companies operating in our target markets, while disposables sales increased by $3.3 million as a result of the continued progression of our cell therapy partners’ clinical development programs and growth in our customer base.

In the drug discovery market, the $0.7 million increase was principally due to an increase in sales of disposables, including both single-well and multi-well processing assemblies, and an increase in sales of instruments, including the VLx, which was launched in September 2022.

The $2.1 million increase in program-related revenues resulted from achievement of contractually specified clinical progress milestones and reflects the expected variability from period to period in the level of program-related revenue given the small number of individual triggering events which currently generate this portion of revenue.

We expect program-related revenue to continue to experience variability for some time, although we anticipate that variability may moderate as the volume of SPL partnerships and associated milestones grows.

Cost of Goods Sold and Gross Profit

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Gross profit increased by $8.9 million, or 29%, for the year ended December 31, 2022, compared to the year ended December 31, 2021.

The increase was primarily driven by increased revenue from instrument sales and licenses and disposable sales partially offset by the decrease in program related revenues.

The increase was primarily driven by increased revenue from instrument sales and licenses and disposable sales as well as increased program-related revenue.

Operating Expenses

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Research and development

Research and development expenses decreased by $2.3 million, or 13%, for the year ended December 31, 2021, compared to the year ended December 31, 2020.

The decrease was primarily driven by a $5.8 million decrease in CARMA expenses as a result of the wind-down of CARMA operations, partially offset by a $1.1 million increase in compensation expenses associated with headcount increases, a $1.4 million increase in stock-based compensation primarily due to stock price appreciation, a $0.5 million increase in product development and lab expenses and a $0.3 million increase in occupancy expenses.

Research and development expenses increased by $4.1 million, or 27%, for the year ended December 31, 2022, compared to the year ended December 31, 2021.

The increase was primarily driven by a $3.1 million increase in compensation expenses associated with headcount increases, a $1.8 million increase in stock-based compensation expense, a $1.2 million increase in lab supplies expenses and product development costs, a $0.8 million increase in occupancy expense, a $0.5 million increase in travel expenses, and a $0.6 million increase in professional service fees and other expenses, partially offset by a $4.4 million decrease in CARMA expenses as a result of the wind-down of our CARMA operations in 2021.

Sales and Marketing

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Sales and marketing expenses increased by $5.7 million, or 43%, for the year ended December 31, 2022, compared to the year ended December 31, 2021.

The increase was primarily driven by a $2.9 million increase in compensation expenses as a result of increases in headcount and commissions on sales and a $1.0 million increase in stock-based compensation primarily due to stock price appreciation and a $0.5 million increase in marketing expenses.

The increase was primarily driven by a $2.5 million increase in compensation expenses as a result of increases in headcount and commissions on sales, a $2.0 million increase in marketing and travel expenses, and a $1.1 million increase in stock-based compensation expense.

General and Administrative

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General and administrative expense increased by $7.2 million, or 38%, for the year ended December 31, 2022, compared to the year ended December 31, 2021.

The increase was primarily driven by a $3.8 million increase in compensation expense associated with headcount and salary increases, a $3.4 million increase in stock-based compensation primarily due to stock price appreciation, a $2.0 million increase in expenses including legal and professional services, a $1.1 million increase in expense associated with the costs of our common stock being listed on the Nasdaq stock exchange, and a $0.7 million increase in recruiting fees and other general expenses.

Depreciation and Amortization

Year Ended December 31,

(in thousands, except percentages)

Depreciation and amortization

Depreciation and amortization expense increased by $0.3 million, or 32%, for the year ended December 31, 2021, compared to the year ended December 31, 2020.

The increase was primarily driven by a significant investment in capital assets made in 2020 and 2021 for laboratory associated equipment.

Interest and Other Income (Expense)

Year Ended December 31,

(in thousands, except percentages)

Interest and other expense

Interest and other income

Interest and other income were immaterial in the years ended December 31, 2021 and 2020.

Interest and other expense increased by $0.2 million, or 27%, for the year ended December 31, 2021, compared to the year ended December 31, 2020.

The increase was primarily driven by the termination fees associated with repayment before maturity of the MidCap loan and the fair value change of common stock warrants prior to their full exercise.

Comparison of the Years Ended December 31, 2020 and 2019

The results of operations presented below should be reviewed in conjunction with the consolidated financial statements and notes included elsewhere in this Annual Report.

The following tables set forth our results of operations for the periods presented:

(in thousands)

Total revenue

Cost of goods sold

Operating expense

Research and development

Sales and marketing

General and administrative

Depreciation and amortization

Total operating expense

Operating loss

Other income (expense)

Interest and other expense

Interest and other income

Total other income (expense)

(in thousands, except percentages)

Drug discovery

Program-related

Total revenue

Total revenue for the year ended December 31, 2020 was $26.2 million, an increase of $4.5 million, or 21%, compared to revenue of $21.6 million during the year ended December 31, 2019.

Our overall increase in revenue primarily was driven by growth among cell therapy customers in the number of instruments and disposables that we sold, new leased instrument placements, and recurring revenues from existing instrument leases, as well as growth in the number of clinical milestone events that our SPL customers achieved that resulted in payments to us.

Instrument sales and leases and disposable sales increased in part due to continued high levels of capital invested in companies operating in our target markets.

Milestones increased due to the clinical progress of our SPL customers.

Cost of Goods Sold

Year Ended December 31,

(in thousands, except percentages)

Cost of goods sold

Costs of goods sold increased by $0.3 million, or 11%, from the year ended December 31, 2019 to the year ended December 31, 2020.

The increase was primarily driven by higher sales of instruments and disposables.

Cost of goods sold did not increase at the same rate as revenue growth because of the growth in milestone payments, which have no associated cost of goods.

Operating Expenses

Research and Development

Year Ended December 31,

(in thousands, except percentages)

Research and development

Research and development expenses increased by $0.1 million, or 1%, from the year ended December 31, 2019 to the year ended December 31, 2020.

The increase was primarily driven by increased compensation expense associated with field application scientist headcount increases and applications development headcount increases which combined to add $1.4 million to research and development costs, offset by reduced expenses associated with our CARMA activities of $1.1 million and reduced travel expenses of $0.3 million during 2020 due to the impact of the COVID-19 pandemic.

Sales and Marketing

Year Ended December 31,

(in thousands, except percentages)

Sales and marketing

Sales and marketing expenses increased by $0.5 million, or 6%, from the year ended December 31, 2019 to the year ended December 31, 2020.

The increase was primarily driven by increased compensation expense as a result of headcount increases, commissions on sales, and stock-based compensation which added $1.8 million to sales and marketing costs, partially offset by COVID-19 driven reductions in travel and marketing expenses of $1.3 million.

As travel and in-person restrictions instituted due to COVID-19 begin to recede, we expect travel and marketing expenses to increase.

General and Administrative

Year Ended December 31,

(in thousands, except percentages)

General and administrative

General and administrative expense increased by $1.8 million, or 33%, from the year ended December 31, 2019 to the year ended December 31, 2020.

The increase was primarily driven by increased compensation expense associated with headcount increases, salary increases, and stock-based compensation which added $1.5 million within the general and administrative function as well as $0.6 million of expenses associated with capital raising activities that were not eligible to be capitalized.

The increase was primarily driven by a $2.1 million increase in expense associated with the costs of our common stock being listed on the Nasdaq stock exchange, including insurance and related legal expenses, a $2.0 million increase in compensation expense associated with headcount and salary increases, a $1.1 million increase in occupancy expense related to our new office lease, a $1.0 million increase in stock-based compensation expense, and a $0.7 million increase in other general office expenses, including taxes.

Depreciation and Amortization

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Depreciation and amortization expense increased by $1.2 million, or 87%, for the year ended December 31, 2022, compared to the year ended December 31, 2021.

The increase was primarily driven by a significant investment in capital assets made in 2019 and 2020 for laboratory equipment and internally developed software.

The increase was primarily driven by increases in leasehold improvements and investments in laboratory equipment and consignment instruments.

Interest and Other Income (Expense)

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Interest and other income

Interest and other expense increased by $0.1 million, or 21%, from the year ended December 31, 2019 to the year ended December 31, 2020.

The increase was primarily driven by the fair value change of common stock warrants, partially offset by fees associated with an early prepayment of debt in 2019 and the lower interest expenses due to a lower average loan balance associated with an early repayment of debt in 2019.

Interest and other income decreased by $0.1 million, or 68%, from the year ended December 31, 2019 to the year ended December 31, 2020.

The decrease was primarily driven by declining interest income due to lower market rates in 2020 on our short-term investments.

Interest and other expense decreased by $0.9 million, or 88%, for the year ended December 31, 2022, compared to the year ended December 31, 2022.

The decrease was primarily driven by the repayment of the Term Loan in March 2021 and the cashless exercise of a warrant in August 2021, which resulted in us no longer incurring interest expense on indebtedness or warrant fair value adjustments.

The increase of $3.8 million in interest and other income was primarily driven by significantly higher average balances of short-term investments resulting from the IPO proceeds received in

August 2021 and increases in interest rates during 2022.

Interest and other income were not material for the year ended December 31, 2021.

Liquidity and Capital Resources

Since our inception, we have experienced losses and negative cash flows from operations.

For the years ended December 31, 2021, 2020 and 2019, we incurred net losses of $19.1 million, $11.8 million and $12.9 million, respectively.

For the years ended December 31, 2022 and 2021, we incurred net losses of $23.6 million and $19.1 million, respectively.

As of December 31, 2022, we had an accumulated deficit of $137.9 million.

To date, we have funded our operations primarily with proceeds from sales of common stock, borrowings under loan agreements and cash flows associated with sales and licenses of our products to customers.

On August 3, 2021, we completed our IPO, generating gross proceeds of $201.8 million.

On August 3, 2021, we completed our Nasdaq IPO, generating gross proceeds of $201.8 million.

We received net proceeds of $184.3 million after deducting aggregate underwriting commissions and offering expenses of $17.6 million.

As of December 31, 2022, we had cash and cash equivalents and short-term investments of $227.3 million.

We expect to incur increased near-term operating losses as we continue to invest in expanding our business through growing our sales and marketing efforts, continued research and development, product development and expanding our product offerings.

Based on our current business plan, we believe the net proceeds from the IPO, together with our existing cash and cash equivalents, will enable us to fund our operating expenses and capital expenditure requirements for the foreseeable future.

We expect to incur near-term operating losses as we continue to invest in expanding our business through growing our sales and marketing efforts, continued research and development, product development and expanding our product offerings.

Based on our current business plan, we believe that our existing cash, cash equivalents, short-term investments and internally generated cash flows will enable us to fund our operating expenses and capital expenditure requirements for at least the next 12 months.

We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we expect.

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• the cost of our research and development activities and successful development of data supporting use of our products for new applications, and timely launch of new features and products;

• Our ability to enter into additional SPLs and licenses for clinical use of our platform in the future;

• sales to existing and new customers and the progress of our SPL partners in developing their pipelines of product candidates;

• our ability to enter into additional SPL partnerships and licenses for clinical use of our platform in the future;

• changes in the amount of capital available to existing and emerging customers in our target markets;

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If we raise additional funds through collaboration and licensing arrangements with third parties, it may be necessary to relinquish some rights to our technologies or our products, or grant licenses on terms that are not favorable to us.

If we are unable to raise additional capital when desired, we may have to delay development or commercialization of future products.

If we are unable to raise additional

capital when desired, we may have to delay development or commercialization of future products.

We also may have to reduce marketing, customer support or other resources devoted to our existing products.

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Financing activities

Net increase in cash and cash equivalents

Net (decrease) increase in cash and cash equivalents

Operating Activities

Net cash used in operating activities for the year ended December 31, 2021 was $10.7 million, and consisted primarily of our net loss of $19.1 million, offset in part by net non-cash expenses of $10.0 million, including stock-based compensation of $8.0 million, depreciation and amortization expenses of $1.4 million, and warrant liability fair value adjustments of $0.6 million.

Net cash used in operating activities for the year ended December 31, 2022 was $14.8 million, and consisted primarily of our net loss of $23.6 million, offset in part by net non-cash expenses of $12.0 million, including stock-based compensation of $11.8 million, depreciation and amortization expenses of $2.7 million, offset by the amortization of $2.7 million of discounts on short-term investments.

We also had net cash outflows of $3.2 million due to net changes in our operating assets and liabilities.

and accrued expenses of $2.1 million, partially offset by a $2.3 million increase in prepaid expenses and other current assets, a $1.7 million increase in accounts receivable and a $1.4 million increase in inventory.

Net cash used in operating activities for the year ended December 31, 2020 was $8.8 million, and consisted primarily of our net loss of $11.8 million, offset in part by net non-cash expenses of $3.9 million, including stock-based compensation of $2.5 million and depreciation and amortization expenses of $1.0 million.

Net changes in our operating assets and liabilities consisted primarily of an increase in the net effect of our right-of- use assets and lease liabilities of $6.2 million, an increase in other liabilities of $0.9 million and a decrease in prepaid expenses and other current assets of $0.5 million, partially offset by a $4.8 million increase in accounts receivable, a $3.5 million increase in inventory, a $1.9 million increase in tenant improvement allowances receivable and a $0.5 million decrease in other assets.

We also had net cash outflows of $1.6 million due to net changes in our operating assets and liabilities.

Net changes in our operating assets and liabilities consisted primarily of an increase in deferred revenue of $1.6 million and an increase in accounts payable and accrued expenses of $0.4 million, partially offset by a $1.8 million increase in accounts receivable, a $0.9 million increase in inventory, a $0.2 million increase in other current and non-current assets and a $0.1 million increase in the net effect of our right-of-use assets and lease liabilities.

Net cash used in operating activities for the year ended December 31, 2019 was $8.8 million, and consisted primarily of our net loss of $12.9 million, offset in part by net non-cash expenses of $2.5 million, including stock-based compensation of $1.8 million and depreciation and amortization expenses of $0.6 million.

We also had net cash inflows of $1.6 million due to changes in our operating assets and liabilities.

Net changes in our operating assets and liabilities consisted primarily of a decrease in accounts receivable of $1.6 million, an increase in accounts payable and accrued expenses of $1.2 million, an increase in deferred revenue of $0.8 million and a $0.5 million increase in the net effect of our right-of- use assets and lease liabilities, partially offset by a $1.9 million increase in inventory and a $0.7 million increase in other current and non-current liabilities.

Net changes in our operating assets and liabilities consisted primarily of an increase in deferred revenue (consisting primarily of unrecognized instrument license revenue) of $1.9 million and an increase in accounts payable and accrued expenses of $2.1 million, partially offset by a $2.3 million increase in prepaid expenses and other current assets, a $1.7 million increase in accounts receivable and a $1.4 million increase in inventory.

Investing Activities

Cash used in investing activities during the year ended December 31, 2021 was $195.0 million, which was primarily attributable to net purchases of short-term marketable securities of $191.2 million, as well as purchases of property and equipment of $1.5 million and capitalized new product development costs of $2.3 million.

Cash used in investing activities during the year ended December 31, 2022 was $24.8 million, which was primarily attributable to maturities of short-term marketable securities of $284.6 million, partially offset by purchases of short-term marketable securities of $290.9 million, capitalized lease-related construction expenses of $14.2 million, purchases of equipment and furniture of $3.9 million and capitalized internal-use software of $1.0 million.

Purchases of short-term marketable securities are made as part of ordinary course investing activities in compliance with our investment policy which has as its primary objective preservation of principal.

Cash used in investing activities during the year ended December 31, 2020 was $16.6 million, which was primarily attributable to net purchases of marketable securities of $14.5 million and purchases of property and equipment of $2.1 million.

Cash provided by investing activities during the year ended December 31, 2019 was $0.5 million, which was primarily attributable to net purchases and maturities of marketable securities of $1.7 million, partially offset by purchases of property and equipment of $1.3 million.

Financing Activities

Net cash provided by financing activities during the year ended December 31, 2021 was $234.7 million, which was primarily attributable to net proceeds of $236.1 million, including $51.8 million from the issuance of common stock in the first quarter and $184.3 million from the IPO in the third quarter of 2021, and proceeds of $3.6 million from the exercise of stock options, partially offset by the repayment of the Midcap loan of $4.9 million.

Cash provided by financing activities during the year ended December 31, 2020 was $28.9 million, which was primarily attributable to net proceeds from issuance of common stock of $28.6 million and the proceeds of $0.4 million from the exercise of stock options, partially offset by lease principal payments of $0.1 million.

Cash provided by financing activities during the year ended December 31, 2019 was $12.3 million, which was primarily attributable to net proceeds from issuance of common stock of $12.3 million, proceeds from borrowing under our MidCap Credit Agreement of $5.0 million and the proceeds of $0.1 million from the exercise of stock options, partially offset by the repayment of our previously outstanding borrowing under the MidCap Credit Agreement of $5.1 million.

Net cash provided by financing activities during the year ended December 31, 2022 was $2.9 million, which consisted exclusively of proceeds from the exercise of stock options.

Contractual Obligations and Commitments

Our contractual obligations and commitments as of December 31, 2021, consisted of operating lease obligations.

On May 27, 2021, we entered into an operating lease, or the 2021 Lease, for new office, laboratory and warehouse/manufacturing space.

See Part I, Item 2, “Facilities” in this Annual Report for additional information regarding the 2021 Lease.

We will design and construct the leasehold improvements with the approval of the landlord.

The lease agreement includes a landlord-provided tenant improvement allowance of $6.3 million, which will be applied to the construction cost of leasehold improvements.

The total incremental non-cancellable lease payments under the 2021 Lease are approximately $29.9 million over the lease term, which continues until 2035.

On June 8, 2021, we exercised our option to early terminate one of our existing office and lab space lease arrangements.

The amended office lease expires on June 7, 2022.

As of December 31, 2021, operating lease obligations included approximately $1.0 million in payments due under our lease of office and laboratory space under operating lease agreements that expire in October 2023.

In August 2021, we terminated a finance lease and as of December 31, 2021, we did not have any finance lease obligations.

As of December 31, 2020, debt obligations included the contractually required principal and interest payments payable under our MidCap Credit Agreement, under which borrowings bore interest at a variable rate.

On March 12, 2021, we repaid all amounts outstanding under the MidCap Credit Agreement in full.

Our contractual obligations and commitments as of December 31, 2022 consisted exclusively of operating lease obligations.

In May 2021, we entered into an operating lease for new office, lab and warehouse/manufacturing space.

The lease for the new facility consists of three phases, with Phase 1 having commenced in December 2021 and Phase 2 having commenced in the first quarter of 2022.

Phase 3 is expected to begin before November 1, 2023.

The lease term for all phases expires on August 31, 2035.

We designed and constructed the leasehold improvements with the approval of the landlord.

The lease provides that the landlord will reimburse us for costs of property improvements up to amounts specified in the lease.

The total incremental non-cancellable lease payments under the lease agreement are $29.6 million through the lease term.

We expect to be able to fund our obligations under the new lease, both in the short term and in the long term, from cash on hand, short-term investments and operating cash flows.

See Part I, Item 2, “Facilities” in this Annual Report for additional information regarding the new office lease.

On June 8, 2021, we exercised our option to early terminate one of our office and lab space lease arrangements associated with our former headquarters facility.

That amended office lease expired on June 7, 2022.

In June 2022, we exercised our option to early terminate our remaining subleased office, laboratory, manufacturing and other spaces associated with our former headquarters facility, which became effective in July and August 2022.

These subleases previously had expiration dates in October 2023.

In August 2021, we terminated a finance lease and following that termination, we had no finance lease obligations as of December 31, 2022.

We had no debt obligations as of December 31, 2022 or 2021.

Purchase orders or contracts for the purchase of supplies and other goods and services are based on our current procurement or development needs and are generally fulfilled by our vendors within short time horizons.

Critical Accounting Policies and Significant Judgments and Estimates

Critical Accounting Estimates

We have prepared our consolidated financial statements in accordance with generally accepted accounting principles in the United States.

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(iii) measurement of the transaction price, including the assessment of the constraint on variable consideration;

(iv) allocation of the transaction price to the performance

obligations and (v) recognition of revenue when, or as, we satisfy each performance obligation.

(iv) allocation of the transaction price to the performance obligations;

and (v) recognition of revenue when, or as, we satisfy each performance obligation.

At contract inception, we assess the goods or services promised within each contract, determine which goods or services are performance obligations and assess whether each promised good or service is distinct.

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In such arrangements we allocate the sale price to the various performance obligations in the arrangement on a relative standalone selling price basis.

The standalone selling price is the price at which an entity would sell a promised good or service separately to a customer.

We estimate the standalone selling price of each of the identified performance obligations in our customer contracts, maximizing the use of observable inputs.

Our process for determining standalone selling price requires judgment and considers multiple factors that are reasonably available and maximizes the use of observable inputs that may vary over time depending upon the unique facts and circumstances related to each performance obligation.

We believe that this method results in an estimate that represents the price we would charge for the product offerings if they were sold separately.

Under this basis, the Company determines the estimated selling price of each performance obligation in a manner that is consistent with that used to determine the price to sell the deliverable on a standalone basis.

Taxes, such as sales, value-add and other taxes, collected from customers concurrent with revenue generating activities and remitted to governmental authorities are not included in revenue.

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Stock-based Compensation

We maintain an incentive compensation plan under which stock options are granted primarily to employees, consultants and non-employee directors.

We maintain an incentive compensation plan under which stock options and restricted stock units are granted primarily to employees, consultants and non-employee directors.

We measure stock-based compensation expense on the date of grant and recognize the corresponding compensation expense of those awards over the requisite service period, which is generally the vesting period of the respective award.

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We estimate the fair value of stock options granted to our employees and directors based on the closing price of our common stock on the grant date and the resulting stock-based compensation expense using the Black-Scholes option-pricing model.

For grants prior to July 30, 2021, the fair value was based on the value of our common stock on the AIM, a market operated by the London Stock Exchange;

for grants after that date, the fair value was based on the value of our common stock on the Nasdaq Global Select Market on the grant date.

For grants prior to July 30, 2021, the fair value was based on the value of our common stock on the AIM;

for grants after that date, the fair value is based on the value of our common stock on the Nasdaq Global Select Market on the grant date.

The Black-Scholes option-pricing model requires the use of assumptions regarding a number of variables that are complex, subjective and generally require significant judgment to determine.

The assumptions include expected volatility using publicly traded peer group companies’ common stock, expected dividend yield, risk-free rate of interest and the expected term using the simplified method.

The assumptions include expected volatility using either publicly traded peer group companies’ common stock (for grants before July 1, 2022) or the Company’s own common stock (for grants beginning on July 1, 2022), expected dividend yield, risk-free rate of interest and the expected term using the simplified method.

Recent Accounting Pronouncements

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Emerging Growth Company Status

We are an “emerging growth company,” or EGC, under the Jumpstart Our Business Startups Act of 2012, or the JOBS Act.

We are an “emerging growth company,” or EGC, under the JOBS Act.

Section 107 of the JOBS Act provides that an EGC can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards.

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We also intend to rely on other exemptions provided by the JOBS Act, including not being required to comply with the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act.

We will remain an emerging growth company until the earliest of:

We will remain an EGC until the earliest of:

(i) December 31, 2026, which is the last day of the fiscal year following the fifth anniversary of our initial public offering in the United States;

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and (iv) the last day of the fiscal year in which the market value of our common stock held by non-affiliates exceeded $700 million as of June 30 of such fiscal year.

Based on the current market value of our common stock, it is possible that we may lose emerging growth company status as of December 31, 2022.

We are also a “smaller reporting company,” as defined by Rule 12b-2 of the Exchange Act.

We may continue to be a smaller reporting company if either (i) the market value of our stock held by non-affiliates is less than $250 million as of the last business day of our second fiscal quarter or (ii) our annual revenue is less than $100 million during the most recently completed fiscal year and the market value of our stock held by non-affiliates is less than $700 million as of the last business day of our second fiscal quarter.

If we are a smaller reporting company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies.

Specifically, as a smaller reporting company we have elected to present only the two most recent fiscal years of audited financial statements in this Annual Report.

In addition, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 7. Management’s Discussion and Analysis