What changed in this filing

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Item 5. Market for Registrant’s Common Equity

2023-03-15 compared with 2022-03-23 · 95 added, 68 removed, 231 unchanged (41% of the section changed)

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Our common stock trades under the symbol “AURA”.

Prior to this time, there was no public market for our common stock.

Holders of record

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We anticipate that we will retain all available funds and any future earnings, if any, for use in the operation of our business and do not anticipate paying cash dividends in the foreseeable future.

Securities Authorized for Issuance Under Equity Compensation Plans

The information required by Item 5 of Form 10-K regarding equity compensation plans is incorporated herein by reference to Item 12 of Part III of this Annual Report.

Stock performance graph

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Recent Sales of Unregistered Equity Securities

On November 2, 2021, upon the closing of our IPO, all 308,332,857 shares of our then-outstanding convertible preferred stock automatically converted into 22,550,561 shares of our common stock.

The issuance of such common stock was exempt from the registration requirements of the Securities Act, pursuant to Section 3(a)(9) of the Securities Act, involving an exchange of securities exchanged by the issuer with its existing security holders exclusively where no commission or other remuneration is paid or given directly or indirectly for soliciting such exchange.

No underwriters were involved in this issuance of shares.

During the period between January 1, 2021 and September 30, 2021, we issued to certain of our employees, advisors and directors, options to purchase an aggregate of 1,883,480 shares of our common stock at an average exercise price of $6.13 per share.

We deemed these issuances to be exempt from registration under the Securities Act in reliance on Rule 701 of the Securities Act as sales and offers under compensatory benefit or Section 4(a)(2) of the Securities Act as sales and offers not involving a public offering.

Use of Proceeds from Initial Public Offering of Common Stock

On November 2, 2021, the Company completed its initial public offering, or the IPO, in which it issued and sold 5,400,000 shares of its common stock at a public offering price of $14.00 per share.

The Company received net proceeds from the IPO of $67.8 million, after deducting underwriters’

On November 2, 2021, we completed our initial public offering, or the IPO, in which we issued and sold 5,400,000 shares of our common stock at a public offering price of $14.00 per share.

We received net proceeds from the IPO of $67.8 million, after deducting underwriters’

discounts, commissions and offering-related costs.

In connection with the IPO, the Company granted the underwriters a 30-day option to purchase an additional 810,000 shares.

On November 8, 2021, the underwriters exercised the option in full and the Company issued 810,000 shares of common stock for aggregate net proceeds of $10.5 million after deducting underwriter discounts and commissions of $0.8 million.

In connection with the IPO, we granted the underwriters a 30-day option to purchase an additional 810,000 shares.

On November 8, 2021, the underwriters exercised the option in full and we issued 810,000 shares of common stock for aggregate net proceeds of $10.5 million after deducting underwriter discounts and commissions of $0.8 million.

The offer and sale of all of the shares of our common stock in our IPO were registered under the Securities Act pursuant to a registration statement on Form S-1, as amended (File No.

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and BTIG, LLC acted as underwriters for the IPO.

No expenses incurred by the Company in connection with the IPO were paid directly or indirectly to (i) any of its officers or directors or their associates, (ii) any persons owning 10% or more of any class of its equity securities, or (iii) any of its affiliates, other than payments in the ordinary course of business to officers for salaries and to non-employee directors as compensation for board or board committee service.

There has been no material change in the planned use of proceeds from the IPO from those disclosed in the Prospectus.

No expenses incurred by us in connection with the IPO were paid directly or indirectly to (i) any of our officers or directors or their associates, (ii) any persons owning 10% or more of any class of our equity securities, or (iii) any of our affiliates, other than payments in the ordinary course of business to officers for salaries and to non-employee directors as compensation for Board or Board committee service.

There has been no material change in the planned use of proceeds from the IPO from those disclosed in the IPO prospectus.

We plan to invest the funds received in cash equivalents and other marketable securities in accordance with our investment policy.

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Management’s Discussion and Analysis of Financial Condition and Results of Operations.

You should read the following discussion and analysis of our financial condition and results of operations together with our consolidated financial statements and the related notes thereto included i n Part II, Item 8 “Financial Statements and Supplementary Data”

This discussion contains forward-looking statements that reflect our plans, estimates and beliefs and involve numerous risks and uncertainties, including but not limited to those described in Part I, Item 1A “Risk Factors”

of this Annual Report on Form 10-K.

Actual results may differ materially from those contained in any forward-looking statements.

You should carefully read “Special Note Regarding Forward-Looking Statements”

and Part I, Item 1A, “Risk Factors.”

We are a clinical-stage biotechnology company leveraging our novel targeted oncology platform to develop a potential new standard of care across multiple cancer indications, with an initial focus on ocular and urologic oncology.

The following discussion and analysis should be read in conjunction with the audited consolidated financial statements and related notes included elsewhere in this Annual Report.

This discussion and analysis and other parts of this Annual Report contain forward-looking statements based upon current beliefs, plans and expectations that involve risks, uncertainties and assumptions, such as statements regarding our plans, objectives, expectations, intentions and projections.

Our actual results and the timing of selected events could differ materially from those anticipated in these forward-looking statements as a result of several factors, including those set forth under Part I, Item 1A, “Risk Factors”

and elsewhere in this Annual Report.

You should carefully read the “Risk Factors”

section of this Annual Report to gain an understanding of the important factors that could cause actual results to differ materially from our forward-looking statements.

Please also see the section entitled “Special Note Regarding Forward-Looking Statements.”

We are a clinical-stage biotechnology company envisioning a new way to treat cancer.

Leveraging our novel targeted oncology platform, we have the goal to develop a new standard of care across multiple cancer indications.

Our initial focus is on ocular and urologic oncology where the disease is diagnosed early and there is a high unmet medical need for targeted local therapies.

Our proprietary platform enables the targeting of a broad range of solid tumors using Virus-like Particles, or VLPs, that can be conjugated with drugs or loaded with nucleic acids to create Virus-like Drug Conjugates, or VDCs.

Our VDCs are largely agnostic to tumor type and can recognize a surface marker, known as heparan sulfate proteoglycans, or HSPGs, that are specifically modified and broadly expressed on many tumors.

AU-011, our first VDC candidate, is being developed for the first line treatment of primary choroidal melanoma, a rare disease with no drugs approved.

We have completed a Phase 1b/2 trial using intravitreal administration that has demonstrated a statistically significant growth rate reduction in patients with prior active growth and high levels of tumor control with visual acuity preservation in a majority of patients, as assessed using clinical endpoints in alignment with the feedback from U.S.

Food and Drug Administration, or the FDA.

These data supported advancement into a Phase 2 dose escalation trial, where we are currently evaluating suprachoroidal, or SC, administration of AU-011.

We plan to present six to twelve month safety and efficacy data from this trial in 2022 and, take a decision on the route of administration to, initiate a pivotal trial in the second half of 2022.

We are also developing AU-011 for additional ocular oncology indications and plan to file an IND in the United States in the second half of 2022 for choroidal metastases.

Leveraging our VDCs’

broad tumor targeting capabilities, we also plan to initiate a Phase 1a trial in non-muscle invasive bladder cancer, or NMIBC, our first non-ophthalmic solid tumor indication, in the second half of 2022 and present Phase 1a data from this trial in 2023.

We were incorporated as a Delaware corporation in 2009 and our headquarters are located in Cambridge, Massachusetts.

Our VDCs are largely agnostic to tumor type and can recognize a subset of modified tumor associated glycosaminoglycans, or GAGs, that are part of the heparan sulphate chain of HSPGs expressed on the cell surface of many tumor cells and in the tumor microenvironment.

Bel-sar, our first VDC candidate, is being developed for the first-line treatment of early-stage choroidal melanoma, a rare disease with no drugs approved where the standard of care leaves many patients with blindness.

We have received orphan drug designation for the treatment of uveal melanoma from the U.S Food and Drug Administration, or FDA, and the European Medicines Agency, or EMA, and fast track designation from the FDA for the treatment of choroidal melanoma.

We have completed a Phase 1b/2 trial using intravitreal administration that has demonstrated clinical proof of concept, assessed using endpoints in alignment with the feedback from the FDA.

We are currently evaluating suprachoroidal, or SC, administration of bel-sar in a Phase 2 study.

In February 2023 we presented average nine-month interim safety and efficacy data from this ongoing trial at Macula Society’s Annual Meeting which demonstrated a favorable safety profile with no posterior inflammation and no treatment-related serious adverse events, or SAEs, reported as of January 10, 2023.

The results, with an average of nine months of follow up in patients who received a therapeutic regimen with three cycles of therapy, and who match the criteria for the planned global Phase 3 trial (n=8), showed a statistically significant reduction in the tumor growth rate (-0.289 mm/yr, p = <0.0001) compared to each patient’s documented growth rate at study entry, and a 100% (8/8) tumor control.

In addition, the visual acuity preservation in the group of patients was 88% (7/8), with the majority of patients being at high-risk for vision loss with tumors close to fovea or optic disk.

We have selected the SC route to conduct our global Phase 3 trial in alignment with regulatory agencies.

We are currently conducting start up activities for the global Phase 3 study with the goal to dose our first patient in the first half of 2023.

We are also developing bel-sar for additional ocular oncology indications and have an open IND in the United States for choroidal metastasis, supporting the potential of bel-sar to provide a novel treatment option that preserves vision for these patients.

Choroidal metastasis is a high unmet medical need and the most common intraocular malignancy that is caused by multiple primary cancers in the body that metastasize to the eye (e.g., breast and lung cancer).

These patients are treated by the same ocular oncologists that treat choroidal melanoma and there are no drugs approved that can treat the lesion in the eye and preserve vision.

We received fast track designation from the FDA’s Division of Oncology and plan to initiate a Phase 2 study in this indication in the second half of 2023.

In addition to our ocular oncology franchise, we are leveraging our targeted oncology platform to develop bel-sar in the field of urologic oncology with an initial indication for the treatment of non-muscle invasive bladder cancer, or NMIBC, where we received fast track designation by the FDA’s Division of Oncology.

We initiated enrollment in a Phase 1 trial and we plan to present initial data from this trial in the second half of 2023.

We were incorporated as a Delaware corporation in 2009 and, as of August 1, 2022, our headquarters are located in Boston, Massachusetts.

Since our inception, we have focused our efforts on identifying and developing potential product candidates, conducting preclinical studies and clinical trials, organizing and staffing our company, business planning, establishing our intellectual property portfolio, raising capital, conducting discovery, research and development activities and providing general and administrative support for these operations.

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From inception through December 31, 2022, we have raised an aggregate of approximately $320.6 million of gross proceeds primarily from private placements of our equity and convertible preferred stock as well as through the issuance of our common stock.

On December 5, 2022, we issued and sold 7,705,000 shares of common stock, including the full exercise of the underwriters’

option to purchase additional shares at a price to the public of $12.00 per share, for aggregate gross proceeds of $92.5 million, or the Follow-On Offering.

We received approximately $86.7 million in net proceeds from the Follow-On Offering after deducting underwriting discounts, commissions and offering expenses.

On November 1, 2022, we filed a shelf registration statement on Form S-3, or the 2022 Shelf, with the SEC in relation to the registration of up to an aggregate offering price of $250.0 million of common stock, preferred stock, debt securities, warrants and units or any combination thereof.

We also simultaneously entered into an Open Market Sale Agreement SM , or the Sales Agreement, with Jefferies LLC, or the Sales Agent, to provide for the offering, issuance and sale by us of up to an aggregate of $75.0 million of its common stock from time to time in “at-the-market”

offerings, or the ATM, under the 2022 Shelf and subject to the limitations thereof.

We issued 732,189 shares of our common stock at an average price of $12.51 for aggregate gross proceeds of $9.2 million as of December 31, 2022 under the Sales Agreement.

In November 2021, we issued and sold 6,210,000 shares of our common stock, including the full exercise of the underwriters’

option to purchase additional shares at a price to the public of $14.00 per share for aggregate gross proceeds of $86.9 million in our IPO.

We received approximately $78.3 million in net proceeds after deducting underwriting discounts, commissions and offering expenses.

option to purchase additional shares at a price to the public of $14.00 per share for aggregate gross proceeds of $86.9 million in our initial public offering, or IPO.

We received approximately $78.3 million in net proceeds from the IPO after deducting underwriting discounts, commissions and offering expenses.

We have incurred significant operating losses in every year since our inception in 2009 and have not generated any revenue.

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We expect that our expenses and capital requirements will increase substantially if and as we:

conduct our current and future clinical trials of AU-011;

conduct our current and future clinical trials of bel-sar;

progress the preclinical and clinical development of new indications;

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If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and be forced to reduce or terminate our operations.

As of December 31, 2021, we had cash and cash equivalents of $149.1 million.

In November 2021, we issued and sold 6,210,000 shares of our common stock, including the full exercise of the underwriters’

option to purchase additional shares at a price to the public of $14.00 per share for aggregate gross proceeds of $86.9 million in our IPO.

We received approximately $78.3 million in net proceeds after deducting underwriting discounts, commissions and offering expenses.

We believe that 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 into 2024.

As of December 31, 2022, we had cash and cash equivalents and marketable securities of $188.8 million.

We believe that our existing cash and cash equivalents and marketable securities will enable us to fund our operating expenses and capital expenditure requirements into 2025.

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

See “—Liquidity and Capital Resources”

Impact of the COVID-19 Pandemic

The ongoing COVID-19 pandemic continues to present substantial public health and economic challenges around the world, and to date has led to the implementation of various responses, including government-imposed quarantines, stay-at-home orders, travel restrictions, mandated business closures and other public health safety measures.

We continue to closely monitor the impact of the COVID-19 pandemic on all aspects of our business, including how it has and will continue to impact our operations and the operations of our suppliers, vendors and business partners, and may take further precautionary and preemptive actions as may be required by federal, state or local authorities.

Impact of the ongoing COVID-19 Pandemic

We continue to closely monitor the impact of the COVID-19 pandemic on all aspects of our business, including how it may continue to impact our operations and the operations of our suppliers, vendors and business partners.

In addition, we have taken steps to minimize the current environment’s impact on our business and strategy, including devising contingency plans and securing additional resources from third-party service providers.

For the safety of our employees and families, we have introduced enhanced safety measures for scientists to be present in our labs and increased the use of third party service providers for the conduct of certain experiments and studies for research programs.

To date, we’ve only encountered minor delays in our manufacturing process due to a supply chain constraint with one of our vendors.

Beyond the impact on our pipeline, the extent to which COVID-19 ultimately impacts our business, results of operations and financial condition will depend on future developments, which remain highly uncertain and cannot be predicted with confidence, such as the duration of the outbreak, the emergence of new variants, new information that may emerge concerning the severity of COVID-19 or the effectiveness of actions taken to contain COVID-19 or treat its impact, including vaccination campaigns, among others.

To date, we’ve only encountered minor delays in our manufacturing process due to a supply chain constraints.

If we or any of the third parties with whom we engage, however, were to experience any additional shutdowns or other prolonged business disruptions, our ability to conduct our business in the manner and on the timelines presently planned could be materially or negatively affected, which could have a material adverse impact on our business, results of operations and financial condition.

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Research and Development Expenses

Research and development expenses consist primarily of costs incurred for our research activities, including our discovery efforts and the development of our AU-011 program, and include:

Research and development expenses consist primarily of costs incurred for our research activities, including our discovery efforts and the development of our bel-sar program, and include:

employee-related expenses, including salaries, related-benefits and stock-based compensation expense for employees engaged in research and development functions;

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expenses incurred under agreements with contract research organizations, or CROs, as well as consultants that conduct and provide supplies for our preclinical studies and clinical trials;

the cost of manufacturing AU-011, including the potential cost of CMOs that manufacture product for use in our preclinical studies and clinical trials and perform analytical testing, scale-up and other services in connection with our development activities;

the cost of manufacturing bel-sar, including the potential cost of CMOs that manufacture product for use in our preclinical studies and clinical trials and perform analytical testing, scale-up and other services in connection with our development activities;

costs associated with preclinical activities and development activities;

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Payments for these activities are based on the terms of the individual agreements, which may differ from the pattern of costs incurred, and are reflected in our financial statements as prepaid or accrued research and development expenses.

We allocate our direct external research and development costs across the entire AU-011 program.

Preclinical expenses consist of external research and development costs associated with activities to support our current and future clinical programs, but are not allocated by specific indications due to the overlap of the potential benefit of those efforts across the entire AU-011 program.

We allocate our direct external research and development costs across the entire bel-sar program.

Research and development activities are central to our business.

We expect that our research and development expenses will increase for the foreseeable future as we continue clinical development for AU-011 and continue to discover and develop additional product candidates.

We expect that our research and development expenses will increase for the foreseeable future as we continue clinical development for bel-sar and continue to discover and develop additional product candidates.

If any of our product candidates enter into later stages of clinical development, they will generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials.

General and Administrative Expenses

General and administrative expenses consist primarily of salaries and other related costs, including stock-based compensation, for personnel in our executive and finance functions.

General and administrative expenses consist primarily of salaries and other related costs, including stock-based compensation, for personnel in our executive and administrative functions.

General and administrative expenses also include professional fees for legal, accounting, auditing, tax and consulting services;

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Other Income (Expense)

Our other income (expense) consists of changes in the fair value of our warrant liability, gain/loss on disposal of fixed assets, and interest income on our invested cash balances.

Our other income (expense) consists of accretion, interest income and realized losses on marketable securities, loss on disposal of fixed assets, and interest income on our invested cash balances.

Since our inception, we have not recorded any U.S.

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As of December 31, 2022, we had federal gross operating loss carryforwards of approximately $155.1 million which may be available to offset future taxable income, of which $44.2 million begin to expire in 2029 and go through 2037 and $110.9 million do not expire.

The state gross operating loss carryforwards of $113.6 million, which may be available to offset future taxable income and which would begin to expire in 2030.

The state gross operating loss carryforwards of $127.5 million, which may be available to offset future taxable income and which would begin to expire in 2030, except for $0.7 million of state NOLs that do not expire.

As of December 31, 2022, we had federal and state research and experimentation credit carryforwards of $6.4 million and $1.9 million, respectively, which may be available to offset future income tax liabilities and which would begin to expire in 2029 and 2028, respectively.

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Other income (expense):

Change in fair value of warrant liability

Interest income (expense), including amortization of discount

Loss from disposal of assets

Total other expense

Net loss and comprehensive loss

Interest income, including amortization and accretion income

Realized loss on marketable securities

Loss on disposal of assets

Other expense

Total other income (expense)

Research and Development Expenses

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Total research and development expenses

Research and development expenses increased to $25.2 million for the year ended December 31, 2021, from $18.0 million for the year ended December 31, 2020, primarily due to ongoing manufacturing development costs for AU-011 and higher personnel expenses from growing headcount due to the progression of clinical trials.

Research and development expenses increased to $42.2 million for the year ended December 31, 2022, from $25.2 million for the year ended December 31, 2021, primarily due to ongoing clinical costs associated with the progression of our phase 2 study and CRO costs associated with the start of our phase 3 global trial, manufacturing and development costs for bel-sar, and higher personnel expenses from growing headcount.

General and Administrative Expenses

General and administrative expenses increased to $10.1 million for the year ended December 31, 2021, from $4.2 million for the year ended December 31, 2020, due to an increase in personnel expenses due to an increase in headcount, as well as general increases in audit, legal, consulting, insurance, regulatory, and facilities expenses related to operating as a public company.

General and administrative expenses increased to $18.1 million for the year ended December 31, 2022, from $10.1 million for the year ended December 31, 2021, primarily driven by personnel expenses, as well as increases in general corporate expenses related to a full year of operating as a public company.

Liquidity and Capital Resources

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Through December 31, 2022, we have raised an aggregate of approximately $320.6 million of gross proceeds primarily from private placements of our equity and convertible preferred stock and warrants, as well as through the issuance of our common stock.

On December 5, 2022, we issued and sold 7,705,000 shares of common stock, including the full exercise of the underwriters’

option to purchase additional shares at a price to the public of $12.00 per share for aggregate gross proceeds of $92.5 million in the Follow-On Offering.

We received approximately $86.7 million in net proceeds from the Follow-On Offering after deducting underwriting discounts, commissions and offering expenses.

On November 1, 2022, we filed the 2022 Shelf with the SEC in relation to the registration of up to an aggregate offering price of $250.0 million of common stock, preferred stock, debt securities, warrants and units or any combination thereof.

We also simultaneously entered into the Sales Agreement with the Sales Agent to provide for the offering, issuance and sale by us of up to an aggregate of $75.0 million of our common stock from time to time in the ATM under the 2022 Shelf and subject to the limitations thereof.

We issued 732,189 shares of our common stock at an average price of $12.51 for aggregate gross proceeds of $9.2 million as of December 31, 2022.

In November 2021, we issued and sold a total of 6,210,000 shares in our IPO of our common stock, including the full exercise of the underwriters’

option to purchase additional shares, at a price to the public of $14.00 per share for aggregate gross proceeds of $86.9 million.

We received approximately $78.3 million in net proceeds after deducting underwriting discounts, commissions and offering expenses.

We received approximately $78.3 million in net proceeds from the IPO after deducting underwriting discounts, commissions and offering expenses.

The following table summarizes our cash flows for each of the periods presented:

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Operating Activities

During the year ended December 31, 2022, net cash used in operating activities was $54.6 million, primarily due to our net loss of $58.8 million and an increase in prepaid expenses and other assets related to clinical and CRO prepayments for bel-sar, partially offset by an increase in stock compensation expense.

During the year ended December 31, 2021, net cash used in operating activities was $32.4 million, primarily due to our net loss of $35.3 million and increase in prepaid expenses and other assets related to clinical trials, partially offset by the non-cash charge related to stock compensation expense, an increase in accrued expenses and other liabilities related to personnel expenses, and clinical trials and increase in accounts payable related to the timing of vendor invoicing and payments.

During the year ended December 31, 2020, net cash used in operating activities was $24.3 million, primarily due to our net loss of $22.2 million and decreases in accrued expenses and other liabilities related to personnel expenses and clinical trials as well as decrease in accounts payable related to the timing of vendor invoicing and payments.

Investing Activities

Net cash used in investing activities for the years ended December 31, 2021 and 2020 was $2.1 million and $0.8 million, respectively, due to purchases of property and equipment.

Net cash used in investing activities for the year ended December 31, 2022 was $67.9 million, primarily due to purchases of marketable securities and property and equipment, partially offset by proceeds from sale and maturities of marketable securities.

Net cash used in investing activities for the year ended December 31, 2021 was $2.1 million, primarily due to purchases of property and equipment.

Financing Activities

During the year ended December 31, 2022, net cash provided by financing activities was $95.6 million from the net proceeds from the follow-on offering, ATM draw-downs, and proceeds from stock option exercises.

During the year ended December 31, 2021, net cash provided by financing activities was $166.3 million from the net proceeds from the IPO, the sale of Series E convertible preferred stock, the second tranche of the Series D-2 convertible preferred stock, and proceeds from stock options exercises.

During the year ended December 31, 2020, net cash provided by financing activities was $10.0 million from the net proceeds from the sale of Series D-2 convertible preferred stock and proceeds from stock options exercises.

Funding Requirements

Our plan of operation is to continue implementing our business strategy, continue research and development of AU-011 and any other product candidates we may acquire or develop and continue to expand our research pipeline and our internal research and development capabilities.

Our plan of operation is to continue implementing our business strategy, continue research and development of bel-sar and any other product candidates we may acquire or develop and continue to expand our research pipeline and our internal research and development capabilities.

We expect our expenses to increase substantially in connection with our ongoing activities, particularly as we advance the preclinical activities and clinical trials of our current and future product candidates.

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the costs of operating as a public company;

our ability to establish a commercially viable pricing structure and obtain approval for coverage and adequate reimbursement from third-party and government payers;

addressing any potential interruptions or delays resulting from factors related to the COVID-19 pandemic;

our ability to establish a commercially viable pricing structure and obtain approval for coverage and adequate reimbursement from third-party and government payors;

addressing any potential interruptions or delays resulting from factors related to the ongoing COVID-19 pandemic;

the effect of competing technological and market developments;

the extent to which we acquire or invest in businesses, products, and technologies;

unfavorable global economic conditions, which may exacerbate the magnitude of the factors discussed above.

A change in the outcome of any of these variables with respect to the development of a product candidate could mean a significant change in the costs and timing associated with the development of that product candidate.

As of December 31, 2021, we had cash and cash equivalents of $149.1 million.

As of December 31, 2022, we had cash and cash equivalents and marketable securities of $188.8 million.

Based on our research and development plans, we believe that our existing cash and cash equivalents, will be sufficient to fund our operations into 2025.

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Operating lease commitments(1)

(1) Amounts in the table above reflect payments due for our lease of office space in Cambridge, Massachusetts that expires July 2023.

(1) Amounts in the table above reflect payments due for our lease of office and lab space in Boston, Massachusetts, that expires in August 2032.

On May 16, 2022, we entered into an office and laboratory lease in Boston, MA with an initial 10-year term and one renewal option to extend the lease for an additional seven years.

The lease commenced on August 1, 2022.

Except as disclosed in the table above, we have no long-term debt or finance leases and no material non-cancelable purchase commitments with service providers, as we have generally contracted on a cancelable, purchase-order basis.

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Payments due upon cancellation consist only of payments for services provided or expenses incurred, including noncancelable obligations of our service providers, up to the date of cancellation.

We have also acquired exclusive and non-exclusive rights to use, research, develop and offer for sale certain products and patents under license agreements.

The license agreements obligate us to make payments to the licensors for license fees, milestones, license maintenance fees and royalties.

These payments are not included in the preceding table as the amount and timing of such payments are not known.

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We account for forfeitures as they occur by reversing any expense recognized for unvested awards.

For grants of restricted stock units, we base the fair value on the stock price as of the date of grant.

We estimate the fair value of options granted using the Black-Scholes option pricing model.

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The fair value of stock-based payments is recognized as expense over the requisite service period which is generally the vesting period.

In the periods prior to the IPO, the determination of fair value of our common stock required significant judgment.

In the periods following the IPO, the fair value of our common stock is determined based on the quoted market price of our common stock.

Prior to our IPO, there was no public market for our common stock, and consequently, the estimated fair value of our common stock was determined by our Board of Directors as of the date of each option grant, with input from management, considering third-party valuations of our common stock as well as our board of directors’

assessment of additional objective and subjective factors that it believed were relevant and which may have changed from the date of the most recent third-party valuation through the date of the grant.

In the periods following the IPO, the fair value of our common stock is determined based on the quoted market price of our common stock.

Recent Accounting Pronouncements

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Specifically, as a smaller reporting company we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Report on Form 10-K and, similar to EGCs, smaller reporting companies have reduced disclosure obligations regarding executive compensation.

Quantitative and Qualitative Disclosures About Market Risk .

Under SEC rules and regulations, as a smaller reporting company, we are not required to provide the information required by this item.

Financial Statements and Supplementary Data .

Our consolidated financial statements, together with the report of our independent registered public accounting firm, appear beginning on page F-1 of this Annual Report for the year ended December 31, 2022.

Changes in and Disagreements with Acco untants on Accounting and Financial Disclosure.

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 5. Market for Registrant’s Common Equity