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Item 7. Management’s Discussion and Analysis

2023-03-09 compared with 2022-03-11 · 86 added, 133 removed, 108 unchanged (67% of the section changed)

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

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

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

This discussion and other parts of this report contain forward-looking statements reflecting our current expectations that involve risks and uncertainties, such as our plans, objectives, expectations, intentions, and beliefs.

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Factors that could cause or contribute to such differences include, but are not limited to, those identified below and those discussed in the section entitled “Risk Factors” included elsewhere in this Annual Report.

Overview and Recent Developments

We are a biotechnology company advancing new treatments for patients with serious diseases that are underserved by today’s therapies.

Marketed therapies often leave room for improvements in efficacy, safety, and/or dosing convenience.

We believe that first-generation drugs rarely represent optimal solutions, and that the potential exists to develop alternatives that improve patient outcomes, moderate side effects, enhance quality of life, ease access, and augment market competition.

Our business model is to identify product opportunities in indications for which clinical trial data demonstrating compelling proof of concept for a targeted mechanism of action already exists, but the competitive evolution of product profiles and number of entrants appears incomplete.

We intend to prioritize indications that fast-follower and bio superior competition could create significant medical benefit for patients.

We are engineering medicines to advance patient care.

We are developing two product candidates, VRDN-001 and VRDN-002, to treat patients who suffer from thyroid eye disease (“TED”).

Our most advanced program, VRDN-001, is a differentiated humanized monoclonal antibody targeting IGF-1R for the treatment for TED.

In November 2021, we opened an investigational new drug (“IND”) application for VRDN-001 as a

new molecular entity and in December 2021, we initiated a Phase 1/2 clinical trial of VRDN-001, which will evaluate proof of concept in TED patients.

Initial proof of concept data in patients are expected in the second quarter of 2022.

VRDN-002, a distinct IGF-1R antibody that incorporates half-life extension technology, is designed to support administration as a convenient, low volume, subcutaneous injection, to treat patients who suffer from TED.

In January 2022, we announced FDA clearance of our IND application for VRDN-002.

During the first quarter of 2022, we expect to initiate a Phase 1 single ascending dose trial to explore safety, tolerability, pharmacokinetics, and pharmacodynamic properties of intravenously administered VRDN-002 in healthy volunteers.

Data from this Phase 1 trial will allow us to evaluate the feasibility of a low-volume dosing paradigm and are expected to be announced in mid-2022.

Pending results, we then plan to evaluate the potential efficacy of a low volume subcutaneous injection of VRDN-002 in TED patients.

In addition to developing therapies for TED, we are executing a similar strategic approach to identify opportunities to develop fast-follower therapies in other serious and/or rare disease indications.

We intend to identify and initiate additional programs over time and plan to disclose these when we are closer to initiating clinical trials in these programs.

Agreement and Plan of Merger

On October 27, 2020, we acquired Viridian Therapeutics, Inc.

(“Private Viridian”).

In accordance with the terms of the Agreement and Plan of Merger, dated October 27, 2020 (the “Merger Agreement”), by and among us, Oculus Merger Sub I, Inc., a Delaware corporation and our wholly owned subsidiary (the “First Merger Sub”), Oculus Merger Sub II, LLC, a Delaware limited liability company and our wholly owned subsidiary (the “Second Merger Sub”), and Private Viridian.

Pursuant to the Merger Agreement, First Merger Sub merged with and into Private Viridian, pursuant to which Private Viridian was the surviving corporation and became our wholly owned subsidiary (the “First Merger”).

Immediately following the First Merger, Private Viridian merged with and into Second Merger Sub, pursuant to which Second Merger Sub was the surviving entity (the “Second Merger,” and together with the First Merger, the “Merger”).

The Merger is intended to qualify as a tax-free reorganization for U.S.

federal income tax purposes.

Our board of directors approved the Merger Agreement and the related transactions.

The consummation of the Merger was not subject to approval of our stockholders.

Under the terms of the Merger Agreement, at the closing of the Merger on October 27, 2020 (the “Closing”) we issued 72,131 shares of our common stock and 203,197 shares of Series A Non-Voting Convertible Preferred Stock (the “Series A Preferred Stock”) (as described below) to the securityholders of Private Viridian.

Each share of Series A Preferred Stock is convertible into 66.67 shares of our common stock, subject to certain conditions described below.

Contingent Value Rights Agreement

In accordance with the Merger Agreement, on November 4, 2020, we and the Rights Agent (as defined therein) executed and delivered a contingent value rights agreement (the “CVR Agreement”), pursuant to which each holder of our common stock as of November 6, 2020, other than former stockholders of Private Viridian, was entitled to one contractual contingent value right issued by us, subject to and in accordance with the terms and conditions of the CVR Agreement, for each share of our common stock held by such holder.

The CVR Agreement terminated as of December 31, 2021 and no CVRs were issued under the CVR Agreement.

Private Placement and Securities Purchase Agreement

On October 27, 2020, we entered into a Securities Purchase Agreement (the “Purchase Agreement”) with the purchasers named therein (the “Investors”).

Pursuant to the Purchase Agreement, we sold an aggregate of approximately 195,290 shares of Series A Preferred Stock for an aggregate purchase price of approximately $91.0 million (collectively, the “Financing”).

Each share of Series A Preferred Stock is convertible into 66.67 shares of our common stock, as described below.

The powers, preferences, rights, qualifications, limitations, and restrictions applicable to the Series A Preferred Stock are set forth in the Certificate of Designation filed in connection with the Merger.

Holders of Series A Preferred Stock are entitled to receive dividends on shares of Series A Preferred Stock equal, on an as-if-converted-to-Common-Stock basis, and in the same form as dividends actually paid on shares of our common stock.

Except as otherwise required by law, the Series A Preferred Stock does not have voting rights.

However, as long as any shares of Series A Preferred Stock are outstanding, we will not, without the affirmative vote of the holders of a majority of the then outstanding shares of the Series A Preferred Stock, (a) alter or change adversely the powers, preferences or rights given to the Series A Preferred Stock, (b) alter or amend the Certificate of Designation, (c) amend its certificate of incorporation or other charter documents in any manner that adversely affects any rights of the holders of Series A Preferred Stock, (d) increase the number of authorized shares of Series A Preferred Stock, (e) at any time while at least 30% of the originally issued Series A Preferred

Stock remains issued and outstanding, consummate a Fundamental Transaction (as defined in the Certificate of Designation) or (f) enter into any agreement with respect to any of the foregoing.

The Series A Preferred Stock does not have a preference upon any liquidation, dissolution, or winding-up of us.

Following stockholder approval of the conversion of the Series A Preferred Stock into shares of common stock in December 2020, each share of Series A Preferred Stock became convertible into shares of our common stock at any time at the option of the holder thereof, into 66.67 shares of our common stock, subject to certain limitations, including that a holder of Series A Preferred Stock is prohibited from converting shares of Series A Preferred Stock into shares of our common stock if, as a result of such conversion, such holder, together with its affiliates, would beneficially own more than a specified percentage (to be established by the holder between 4.99% and 19.99%) of the total number of shares of our common stock issued and outstanding immediately after giving effect to such conversion.

On October 30, 2020, we entered into a Registration Rights Agreement (the “Registration Rights Agreement”), pursuant to which we agreed to register for resale the shares of common stock sold to Investors in the Financing.

The registration statement that was filed pursuant to the Registration Rights Agreement was declared effective by the SEC on December 22, 2020.

Reverse Stock Split

On November 12, 2020, we effected a reverse stock split of our shares of common stock at a ratio of 1-for-15, and trading of our common stock began on a split-adjusted basis on November 13, 2020.

Our common stock is traded on the Nasdaq Capital Market under the ticker symbol “VRDN”.

As a result of the reverse stock split, every 15 shares of our pre-reverse split common stock were combined and reclassified into one share of our common stock.

No fractional shares were issued in connection with the reverse stock split, and in the case the stock split resulted in any stockholders owning a fractional share, then such stockholders received a cash payment in lieu of such fractional share.

The reverse stock split did not modify any rights of our common stock.

The reverse stock split reduced the number of shares of our common stock issuable upon the conversion of our outstanding shares of Series A Preferred Stock to a ratio of 66.67 and the exercise or vesting of outstanding stock options and warrants in proportion to the ratio of the reverse stock split and caused a proportionate increase in the conversion and exercise prices of such preferred stock, stock options, and warrants.

The accompanying consolidated financial statements and notes to the consolidated financial statements in this Annual Report give retroactive effect to the exchange ratio for all periods presented.

Underwritten Public Offering

On September 23, 2021, we completed an underwritten public offering of 7,344,543 shares of common stock, which includes 1,159,089 shares of common stock issued in connection with the exercise in full by the underwriters of their option to purchase additional shares, at a public offering price of $11.00 per share and 23,126 shares of Series B Non-Voting Convertible Preferred Stock (the “Series B Preferred Stock”) at a public offering price of $733.37 per share (collectively, the “Offering”).

The gross proceeds of the Offering, before deducting underwriting discounts and commissions and other offering expenses payable by us, were approximately $97.7 million.

Each share of Series B Preferred Stock is convertible into 66.67 shares of common stock, subject to certain limitations, including that a holder of Series B Preferred Stock is prohibited from converting shares of Series B Preferred Stock into shares of common stock if, as a result of such conversion, such holder, together with its affiliates, would beneficially own more than a specified percentage (to be established by the holder between 4.9% and 19.9%) of the total number of shares of common stock issued and outstanding immediately after giving effect to such conversion.

The powers, preferences, rights, qualifications, limitations, and restrictions applicable to the Series B Preferred Stock are set forth in the Certificate of Designation filed in connection with the Offering.

Holders of Series B Preferred Stock are entitled to receive dividends on shares of Series B Preferred Stock equal, on an as-if-converted-to-Common-Stock basis, and in the same form as dividends actually paid on shares of the common stock.

Except as otherwise required by law, the Series B Preferred Stock does not have voting rights.

However, as long as any shares of Series B Preferred Stock are outstanding, we will not, without the affirmative vote of the holders of a majority of the then outstanding shares of the Series B Preferred Stock, (a) alter or change adversely the powers, preferences or rights given to the Series B Preferred Stock, (b) alter or amend the Certificate of Designation, or (c) amend our certificate of incorporation or other charter documents in any manner that adversely affects any rights of the holders of Series B Preferred Stock.

The Series B Preferred Stock does not have a preference upon any liquidation, dissolution, or winding-up of the Company.

The COVID-19 Pandemic

The on-going COVID-19 pandemic continues to cause disruption throughout the United States and worldwide.

We could be materially and adversely affected by the risks, or the public perception of the risks, related to the COVID-19 pandemic or any other epidemic, pandemic or public health crisis.

Such risks include, but are not limited to, potential disruptions to our supply chain that may limit our ability to manufacture drug product for our clinical trials, and delays to our planned or future clinical trials.

The ultimate extent of the impact of any epidemic, pandemic or other public health crisis on our business, financial condition and results of operations will depend on future developments, which are highly uncertain and cannot be predicted, including new information that may emerge concerning the severity of such epidemic, pandemic or other public health crisis and actions taken to contain or prevent the further spread, among others.

While our business has not been materially impacted by the COVID-19 pandemic to date, we cannot assure you that our business, financial condition and results of operations will not be affected by the COVID-19 pandemic in the future.

We are a biopharmaceutical company focused on discovering and developing potential best-in-class medicines for serious and rare diseases.

We target under-competitive disease areas where marketed therapies often leave room for improvements in efficacy, safety, and/or dosing convenience.

We believe that first-generation medicines rarely represent optimal solutions, especially in rare disease areas, and that there is potential to develop differentiated, best-in-class medicines that could lead to improved patient outcomes, reduced side effects, improved quality of life, expanded market access, and augmented market competition.

Our business model is designed to identify and evaluate product opportunities in disease areas where trial data establishes proof-of-concept for a drug target in the clinic, but the competitive evolution of the product life cycle management and number of entrants appears incomplete.

We intend to prioritize indications where a fast-follower and a potentially differentiated drug candidate, or overall product profile, could create significant medical benefit for patients.

We are engineering medicines to address unmet medical needs for patients and further advance drug innovation.

We are developing three product candidates, VRDN-001, VRDN-002 and VRDN-003, that are being developed for intravenous or subcutaneous administration to treat patients who suffer from thyroid eye disease (“TED”).

Our most advanced program, VRDN-001, is a differentiated humanized monoclonal antibody targeting IGF-1R intravenously administered for the treatment of TED.

Global Economic Considerations

The global macroeconomic environment is uncertain, and could be negatively affected by, among other things, increased U.S.

trade tariffs and trade disputes with other countries, instability in the global capital and credit markets, supply chain weaknesses, and instability in the geopolitical environment, including as a result of the Russian invasion of Ukraine, the rising tensions between China and Taiwan and other political tensions, and lingering effects of the COVID-19 pandemic.

Such challenges have caused, and may continue to cause, recession fears, concerns regarding potential sanctions, rising interest rates, foreign exchange volatility and inflationary pressures.

At this time, we are unable to quantify the potential effects of this economic instability on our future operations.

Financial Operations Overview

Our revenue has historically consisted primarily of up-front payments for licenses, milestone payments, and payments for other research and development services earned under license and collaboration agreements as well as for amounts earned under certain grants we have been awarded.

In 2011, we entered into a license and collaboration agreement (the “Servier Collaboration Agreement”) with Les Laboratoires Servier and Institut de Recherches Servier (collectively, “Servier”).

In August 2019, Servier terminated the Servier Collaboration Agreement, with such termination becoming effective in February 2020.

We completed certain activities under the Servier Collaboration Agreement through the effective termination date in February 2020.

The activities eligible for reimbursement under the Servier Collaboration Agreement were considered a research and development performance obligation and revenue was recognized through the termination date.

In October 2020, we became party to a license agreement with Zenas BioPharma.

Since February 2021, we have entered into several letter agreements with Zenas BioPharma in which we agreed to provide assistance to Zenas BioPharma with certain development activities, including manufacturing.

Under the terms of the Zenas Agreements, we granted Zenas BioPharma an exclusive license to develop, manufacture, and commercialize certain IGF-1R directed antibody products for non-oncology indications in the greater area of China in exchange for upfront non-cash consideration and non-refundable milestone payments upon achieving specific milestone events during the contract term.

Additionally, we may receive royalty payments based on a percentage of the annual net sales of any licensed products sold on a country-by-country basis in the greater area of China.

Zenas BioPharma announced that it had obtained IND approval in China in July 2022.

Under the license agreement, we received a $1.0 million milestone payment from Zenas BioPharma.

Additionally, we are eligible to receive royalty payments based on a percentage of the annual net sales of any licensed products sold on a country-by-country basis in the greater area of China.

The royalty percentage may vary based on different tiers of annual net sales of the licensed products made.

Zenas BioPharma is obligated to make royalty payments to us for the royalty term in the Zenas Agreements.

In May 2022, we entered into a Manufacturing Development and Supply Agreement with Zenas BioPharma to manufacture and supply, or have manufactured and supplied, clinical drug product for development purposes.

In the future, we expect to continue to generate revenue from a combination of license fees and other up-front payments, payments for research and development services, milestone payments, product sales, and royalties in connection with strategic alliances.

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Food and Drug Administration (“FDA”) or when other significant risk factors are abated.

Our research and development expenses may increase if we initiate new clinical trials.

We expect that our research and development expenses will increase as we expand our clinical development programs and initiate new clinical trials.

The process of conducting clinical trials and preclinical studies necessary to obtain regulatory approval is costly and time consuming.

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We anticipate we will make determinations as to which programs to pursue and how much funding to direct to each program on an ongoing basis in response to our ability to maintain or enter into new strategic alliances with respect to each program or potential product candidate, the scientific and clinical success of each future product candidate, and ongoing assessments as to each future product candidate’s commercial potential.

We will need to raise additional capital and may seek additional strategic alliances in the future in order to advance our various programs.

For example, upon receipt of topline data from our planned proof of concept trial of VRDN-002 by the end of 2023, we expect to determine which of VRDN-002 or VRDN-003 to advance into a pivotal Phase 3 trial in the first half of 2024.

We will need to raise additional capital and may seek additional strategic alliances in the future in order to advance the various clinical trials that are part of our clinical development program described above.

General and Administrative Expenses

General and administrative expenses consist primarily of salaries and related benefits, including share-based compensation, and severance and retention benefits related to our finance, accounting, human resources, legal, business development, and other support functions, professional fees for auditing, tax, and legal services, as well as insurance, board of director compensation, consulting, and other administrative expenses.

Acquired In-process Research and Development Expense

Acquired in-process research and development (“IPR&D”) expense resulted from the acquisition of Private Viridian in October 2020.

The acquisition cost allocated to acquire IPR&D with no alternative future use was recorded as expense at the acquisition date.

Other Income (Expense)

Other income (expense) consists primarily of interest income, interest expense, and various income or expense items of a non-recurring nature.

Other Income, net

Other income, net consists primarily of interest income, net of fees, and various income items of a non-recurring nature.

Interest expense consists of cash and non-cash interest expense on our long-term debt.

We earn interest income from interest-bearing accounts, money market funds, and short-term investments.

Interest expense is comprised of interest incurred under prior notes payable.

Critical Accounting Policies and Estimates

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Adjustments to our research and development expenses may be necessary in future periods as our estimates change.

Acquisition of Private Viridian

On October 27, 2020, we completed our acquisition of Private Viridian in accordance with the terms of the Merger Agreement.

We concluded that the acquisition of Private Viridian did not result in the acquisition of a business, as substantially all of the fair value of the non-monetary assets acquired was concentrated in a single identifiable asset, the exclusive license agreement with ImmunoGen.

We considered several pertinent factors and identified the Company as the accounting acquirer in the transaction.

Significant judgment was required in evaluating the terms of the Merger Agreement and in identifying, valuing, and recording the acquired assets at fair value, including acquired IPR&D, and determining the acquirer for accounting purposes.

Results of Operations

Comparison of the Years Ended December 31, 2022 and 2021

2022 2021 Increase (Decrease)

(in thousands)

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General and administrative expenses 35,182 25,805 9,377

Acquired in-process research and development expense — 69,861

Other income (expense), net 4,430 315 4,115

Net loss $ (129,874) $ (79,413) $ (50,461)

Revenue was $3.0 million for the year ended December 31, 2021, compared to $1.1 million for the year ended December 31, 2020.

During the year ended December 31, 2021, revenue was attributable to our collaboration agreement with Zenas

Revenue recognized during the year ended December 31, 2020, was primarily related to research and development activities related to the legacy microRNA programs reimbursable to us under the Servier Collaboration Agreement.

Revenue was $1.8 million for the year ended December 31, 2022, as compared to $3.0 million for the year ended December 31, 2021.

Revenue for both periods was attributable to our collaboration agreement with Zenas BioPharma.

The $1.2 million decrease in revenue is due to the timing of activities performed under the collaboration agreement.

During the year ended December 31, 2022, the Company recognized $1.0 million upon Zenas BioPharma’s achievement of a certain development milestone.

Research and Development Expenses

Research and development expenses were $100.9 million during the year ended December 31, 2022, compared to $56.9 million during the year ended December 31, 2021.

The $28.6 million increase in research and development expenses was primarily attributable to a $22.8 million increase in preclinical outsourcing and manufacturing for our VRDN programs, including expenses to support the IND submissions for VRDN-001 and VRDN-002;

a $6.0 million increase in personnel expenses, due to an increase in headcount;

and a $4.3 million increase in licensing fees.

This increase was partially offset by a $5.8 million decrease in clinical activities due to expenses incurred in 2020 related to our legacy microRNA programs.

The $44.0 million increase in research and development expenses is primarily attributable to an increase of $8.9 million in clinical trial expenses related to our lead product candidates, VRDN-001 and VRDN-002;

an increase of $8.7 million in costs associated with our preclinical programs;

an increase of $7.8 million in personnel related costs, including share-based compensation, due to an increase in headcount;

an increase of $7.6 million in milestone, license and option fees due to milestone and upfront payments to ImmunoGen and Paragon Therapeutics, Inc.;

an increase of $6.5 million in chemistry, manufacturing and controls costs;

and an increase of $2.4 million in consulting expenses.

We expect our research and development expenses to increase as we work to progress our clinical and preclinical programs.

Acquired In-process Research and Development (IPR&D) Expense

Acquired IPR&D expense was $69.9 million during the year ended December 31, 2020.

Acquired IPR&D expense resulted from the acquisition of Private Viridian in October 2020.

The acquisition cost allocated to acquire IPR&D with no alternative future use was recorded as an expense at the acquisition date.

No acquired IPR&D expenses were incurred during the year ended December 31, 2021.

General and Administrative Expenses

General and administrative expenses were $35.2 million during the year ended December 31, 2022, compared to $25.8 million during the year ended December 31, 2021.

The $12.5 million increase in general and administrative expenses was due primarily to a $9.6 million increase in personnel-related costs, reflecting increases in headcount, salaries and bonus expense, severance costs and share-based compensation expense, as well as a $2.4 million increase in consulting and recruiting fees, and a $1.1 million increase in board compensation expenses.

These increases were slightly offset by a decrease of $0.8 million in legal and other professional services.

The $9.4 million increase in general and administrative expenses is due primarily to an increase of $6.0 million in personnel costs, including share based compensation, due to an increase in headcount, as well as an increase of $3.1 million in consulting, professional and license fees.

Other Income, net

Other income, net was $4.4 million during the year ended December 31, 2022 compared to $0.3 million during the year ended December 31, 2021.

Other income, net for the year ended December 31, 2022, is comprised of $4.9 million of interest income earned on short-term investments as well as sub-lease income, offset by $0.5 million in interest expense related to our Hercules

Loan and Security Agreement.

Other income, net for the year ended December 31, 2021, is comprised of interest income earned on short-term investments as well as sub-lease income.

Liquidity and Capital Resources

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As of December 31, 2022, we had $424.6 million in cash, cash equivalents, and short-term investments.

We expect that our current resources will enable us to fund our planned operations into 2024.

We expect that our current resources will enable us to fund our planned operations into the second half of 2025.

We have no products approved for commercial sale and have not generated any revenue from product sales.

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Substantially all of our operating losses resulted from expenses incurred in connection with our research and development programs and from general and administrative costs associated with our operations.

We will continue to require substantial additional capital to continue the development of our product candidates, and potential commercialization activities, and to fund our ongoing operations.

We will continue to require substantial additional capital to continue the development of our product candidates, and potential commercialization activities, and to fund our ongoing operations, including our clinical development plan described above.

The amount and timing of future funding requirements will depend on many factors, including the pace and results of our clinical development efforts, equity financings, securing additional license and collaboration agreements, and issuing debt or other financing vehicles.

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Failure to raise capital as and when needed, on favorable terms or at all, would have a negative impact on our financial condition and our ability to develop our product candidates.

Changing circumstances may cause us to consume capital significantly faster or slower than we currently anticipate.

Changing circumstances, such as changes in the scope and timing of our clinical studies, may cause us to consume capital significantly faster or slower than we currently anticipate.

If we are unable to acquire additional capital or resources, we will be required to modify our operational plans to complete future milestones.

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Should additional capital not be available to us in the near term, or not be available on acceptable terms, we may be unable to realize value from our assets and discharge our liabilities in the normal course of business, which may, among other alternatives, cause us to further delay, substantially reduce, or discontinue operational activities to conserve our cash resources.

Loan and Security Agreement with Hercules Capital, Inc.

On April 1, 2022, we entered into a loan and security agreement (the “Hercules Loan and Security Agreement”) among the Company, certain of our subsidiaries from time to time party thereto (together with the Company, collectively, the “Borrower”), Hercules Capital, Inc.

(“Hercules”) and certain other lenders party thereto (the “Lenders”).

Under the Hercules Loan and Security Agreement, the Lenders provided us with access to a term loan with an aggregate principal amount of up to $75.0 million, in four tranches (collectively the “Term Loan”), consisting of:

(1) an initial tranche of $25.0 million, available through June 15, 2023;

(2) a second tranche of $10.0 million, subject to the achievement of certain regulatory milestones, available through June 15, 2023;

(3) a third tranche of $15.0 million, subject to the achievement of certain regulatory milestones, available through March 15, 2024;

and (4) a fourth tranche of $25.0 million, subject to approval by the Lenders’ investment committee(s), available through December 15, 2024.

The first tranche of $25.0 million will be available to us through June 15, 2023.

Upon signing we drew an initial principal amount of $5.0 million.

The Term Loan bears interest at a floating per annum rate equal to the greater of (1) 7.45% and (2) 4.2% above the Prime Rate, provided that the Term Loan interest rate shall not exceed a per annum rate of 8.95%.

Interest is payable monthly in arrears on the first day of each month.

Per the terms of the Hercules Loan and Security Agreement, we were originally obligated to make interest-only payments through April 1, 2024.

However, upon the achievement of a development milestone the interest-only

period was extended to October 1, 2024.

If additional development milestones are met, the interest-only period will be extended to April 1, 2025 pursuant to a second extension.

We are required to repay the Term Loan amount in equal monthly installments of the principal amount and interest between the end of the interest-only period and the maturity date of October 1, 2026.

In addition, we are required to pay an end-of-term fee equal to 6% of the principal amount of funded Term Loan Advances at maturity, which are being accreted as additional interest expense over the term of the loan.

ATM Agreements

In November 2021, we entered into an Open Market Sale Agreement SM (the “November 2021 ATM Agreement”) with Jefferies LLC (“Jefferies”) under which we can offer and sell, from time to time at our sole discretion, shares of our common stock having an aggregate offering price of up to $75.0 million through Jefferies as our sales agent in an “at the market” offering.

Jefferies will receive a commission equal to 3.0% of the gross sales proceeds of any common stock sold through Jefferies under the November 2021 ATM Agreement.

No shares were sold under the November 2021 ATM Agreement during the year ended December 31, 2021.

As described below, we were previously a party to the April 2021 ATM Agreement (defined below) with Jeffries and the Cowen ATM Agreement (defined below) with Cowen and Company, LLC (“Cowen”) during the years ended December 2021 and 2020, and those agreements are no longer in effect.

In April 2021, we entered into an Open Market Sale Agreement SM (the “April 2021 ATM Agreement”) with Jefferies under which we could offer and sell, from time to time at our sole discretion, shares of our common stock having an aggregate offering price of up to $50.0 million through Jefferies as our sales agent in an “at the market” offering.

In September 2022, we entered into an Open Market Sale Agreement SM (the “September 2022 ATM Agreement”) with Jefferies, LLC (“Jeffries”) pursuant to which we may offer and sell shares of our common stock having an aggregate offering price of up to $175.0 million from time to time at prices and on terms to be determined by market conditions at the time of offering, with Jefferies acting as the sales agent.

Jefferies will receive a commission of 3.0% of the gross proceeds of any shares of common stock sold under the September 2022 ATM Agreement.

As of December 31, 2022, 964,357 shares were sold under the September 2022 ATM Agreement at a weighted average price of $26.01 per share, for aggregate net proceeds of approximately $24.2 million, including commissions to Jefferies as a sales agent.

In November 2021, we entered into an Open Market Sale Agreement SM (the “November 2021 ATM Agreement”) with Jefferies, pursuant to which we could offer and sell shares of our common stock having an aggregate offering price of up to $75.0 million from time to time at prices and on terms to be determined by market conditions at the time of offering, with Jefferies acting as sales agent.

The November 2021 ATM Agreement was terminated in connection with the September 2022 ATM Agreement.

No shares were sold under the November 2021 ATM Agreement prior to its termination.

In April 2021, we entered into an Open Market Sale Agreement SM (the “April 2021 ATM Agreement”) with Jefferies pursuant to which we could offer and sell shares of our common stock having an aggregate offering price of up to $50.0 million at prices and on terms to be determined by market conditions at the time of offering, with Jefferies acting as sales agent.

Jefferies received a commission equal to 3.0% of the gross sales proceeds of any common stock sold through Jefferies under the April 2021 ATM Agreement.

During the year ended December 31, 2021, we sold an aggregate of 2,551,269 shares of common stock pursuant to the terms of the April 2021 ATM Agreement, at a volume weighted-average price of $13.13 per share, for aggregate net proceeds of approximately $32.4 million, including initial expenses for executing the “at the market offering” and commissions to Jefferies as sales agent.

In March 2017, we entered into a common stock Sales Agreement (the “Cowen ATM Agreement”) with Cowen, which allowed for the offer and sale, from time to time, at our sole discretion, shares of our common stock having an aggregate offering price of up to $50.0 million through Cowen as our sales agent.

Effective as of April 23, 2021, we reduced the aggregate offering price under the Cowen ATM Agreement to zero and ceased selling shares thereunder.

Cumulative net proceeds from the sale of 189,763 shares of our common stock through December 2020 were approximately $11.6 million, after giving effect to commissions to Cowen as sales agent and initial expenses for executing the “at the market offering.” No shares were issued in 2021 under the Cowen ATM Agreement.

The April 2021 ATM Agreement was terminated in connection with the November 2021 ATM Agreement.

An aggregate of 2,551,269 shares of common stock were sold pursuant to the April 2021 ATM Agreement prior to its termination, at a volume weighted-average price of $13.13 per share, for aggregate net proceeds of approximately $32.4 million, including commissions to Jefferies as sales agent.

Underwritten Public Offerings

In September 2021, we entered into an underwriting agreement (the “2021 Underwriting Agreement”) with Jeffries, SVB Leerink LLC and Evercore Group, LLC (collectively, the “Underwriters”) for the sale and issuance of 7,344,543 shares of common stock, which includes 1,159,089 shares of common stock issued in connection with the exercise in full by the underwriters of their option to purchase additional shares, at a public offering price of $11.00 per share and 23,126 shares of Series B Non-Voting Convertible Preferred Stock at a public offering price of $733.37 per share (the “2021 Public Offering”).

The aggregate gross proceeds to the Company from the 2021 Public Offering are approximately $97.7 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by us.

In February 2020, we entered into an underwriting agreement with Oppenheimer & Co., Inc.

for the sale and issuance of 1,000,000 shares of our common stock and warrants to purchase 500,000 shares of our common stock (the “2020 Public Offering”).

Each warrant has an exercise price of $16.50 per share, was exercisable immediately and expires on the fifth anniversary of the date of issuance.

The 2020 Public Offering resulted in approximately $13.9 million of net proceeds to us after deducting underwriting commissions and discounts and other estimated offering expenses payable by us and excluding the proceeds from the exercise of the warrants.

In August 2022, we entered into an underwriting agreement (the “2022 Underwriting Agreement”) with Jefferies, SVB Securities LLC and Evercore Group LLC relating to the offer and sale (the “2022 Offering”) of 11,352,640 shares of our common stock, which includes 1,725,000 shares of common stock issued in connection with the exercise in full by the underwriters of their option to purchase additional shares at a public offering price of $23.50 per share, and 28,084 shares of the Company’s Series B Non-Voting Convertible Preferred Stock, at a public offering price of $1,566.745 per share (collectively, the “2022 Public Offering”).

The aggregate gross proceeds to us from the 2022 Public Offering, including the exercise of the option, were approximately $311.0 million, before deducting underwriting discounts and commissions and other offering expenses payable by us.

In September 2021, we entered into an underwriting agreement (the “2021 Underwriting Agreement”) with Jeffries, SVB Leerink LLC and Evercore Group, LLC for the sale and issuance of 7,344,543 shares of common stock, which include 1,159,089 shares of common stock issued in connection with the exercise in full by the underwriters of their option to purchase additional shares at a public offering price of $11.00 per share, and 23,126 shares of Series B Non-Voting Convertible Preferred Stock at a public offering price of $733.37 per share (the “2021 Public Offering”).

Our aggregate gross proceeds from the 2021 Public Offering, including the exercise of the option, were approximately $97.7 million, before deducting underwriting discounts and commissions and estimated offering expenses payable by us.

Purchase Agreements

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Each share of Series A Preferred Stock is convertible into 66.67 shares of our common stock, subject to specified conditions.

The powers, preferences, rights,

qualifications, limitations, and restrictions applicable to the Series A Preferred Stock are set forth in the applicable certificate of designations.

The powers, preferences, rights, qualifications, limitations, and restrictions applicable to the Series A Preferred Stock are set forth in the applicable certificate of designations.

During the year ended December 31, 2021, 138,050 shares of Series A Preferred Stock were converted into 9,203,732 shares of common stock.

In December 2019, we entered into the common stock Purchase Agreement with Aspire Capital, which provides that, subject to the terms, conditions, and limitations set forth therein, Aspire Capital is committed to purchase up to an aggregate of $20.0 million of shares of our common stock over the 30-month term of the Purchase Agreement.

Upon execution of the Purchase Agreement, we sold to Aspire Capital 106,564 shares of common stock at $9.38 per share for proceeds of $1.0 million as the Initial Purchase Shares (as defined in the Purchase Agreement).

In December 2019, we entered into a common stock purchase agreement (the “Aspire Stock Purchase Agreement”) with Aspire Capital Fund, LLC (“Aspire Capital”), which provides that, subject to the terms, conditions, and limitations set forth therein, Aspire Capital is committed to purchase up to an aggregate of $20.0 million of shares of our common stock over the 30-month term of the Aspire Stock Purchase Agreement.

Upon execution of the Aspire Stock Purchase Agreement, we sold to Aspire Capital 106,564 shares of common stock at $9.38 per share for proceeds of $1.0 million as the Initial Purchase Shares (as defined in the Aspire Stock Purchase Agreement).

During the year ended December 31, 2020, we sold to Aspire Capital 412,187 shares of our common stock at a weighted-average price of $21.35 per share for aggregate net proceeds of $8.8 million.

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Operating Activities

Net cash used in operating activities was $54.6 million for the year ended December 31, 2021, and primarily consisted of a net loss of $79.4 million, adjusted for non-cash items of $23.1 million (primarily share-based compensation of $14.5 million and a $7.5 million non-cash charge related to the issuance of common stock as payment for licensing fees to Xencor) and working capital adjustments of $1.7 million.

Net cash used in operating activities was $29.8 million for the year ended December 31, 2020, and primarily consisted of a net loss of $110.7 million, adjusted for non-cash items of $76.5 million (primarily IPR&D expense of $66.0 million that resulted from the acquisition of Private Viridian in October 2020, a $6.0 million non-cash charge related to the issuance of common stock as payment for certain licensing fees, and $3.6 million of share-based compensation expenses) and a $4.4 million increase in working capital.

Net cash used in operating activities was $93.8 million for the year ended December 31, 2022, and primarily consisted of a net loss of $129.9 million, adjusted for non-cash items of $20.1 million (primarily share-based compensation of $19.8 million) and working capital adjustments of $16.0 million.

Investing Activities

Net cash used in investing activities was $74.3 million during the year ended December 31, 2021, compared to net cash used in investing activities of $50.5 million during the year ended December 31, 2020.

Net cash used in investing activities was $115.1 million during the year ended December 31, 2022.

Net cash used in investing activities in 2022 primarily consisted of net purchases of investments of $114.3 million and property and equipment purchases of $0.8 million.

Net cash used in investing activities of $50.5 million in 2020 consisted of net purchases of investments of $79.8 million, offset by $29.4 million of cash acquired in the acquisition of Private Viridian in October 2020.

Net cash used in investing activities was $74.3 million during the year ended December 31, 2021.

Net cash used in investing activities in 2021 primarily consisted of net purchases of investments of $74.0 million and property and equipment purchases of $0.3 million.

Financing Activities

Net cash provided by financing activities was $322.2 million for the year ended December 31, 2022.

Net cash provided by financing activities in 2022 was primarily driven by net proceeds of $313.8 million in net proceeds from the 2022 Public Offering and the September 2022 ATM Agreement, $4.6 million in net proceeds from the Hercules Loan and Security Agreement, as well as $2.8 million in proceeds from the exercise of stock options, $0.9 million in proceeds from the exercise of warrants and $0.2 million in proceeds from the issuance of common stock under our employee stock purchase plan.

Net cash provided by financing activities was $125.3 million for the year ended December 31, 2021.

Net cash provided by financing activities in 2021 was primarily driven by net proceeds of $107.3 million from the sale of common stock in 2021 through the 2021 Public Offering and the April 2021 ATM Agreement, $15.7 million in net proceeds from the sale of our Series B Preferred Stock, $1.3 million from the exercise of common stock warrants, and $1.0 million in proceeds from employee stock option exercises.

Net cash provided by financing activities was $101.3 million for the year ended December 31, 2020, and consisted primarily of $86.1 million in net proceeds from the sale of Series A Preferred Stock, $23.8 million in net proceeds from the sale of common stock warrants.

These inflows were offset by $8.6 million in repayments of then outstanding notes payable.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

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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