What changed in this filing

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Item 1. Financial Statements

2023-08-03 compared with 2023-05-11 · 372 added, 217 removed, 691 unchanged (46% of the section changed)

34 unchanged sentences

THREE MONTHS ENDED

SIX MONTHS ENDED

Operating expenses:

7 unchanged sentences

Basic and diluted net loss per share

Shares used in computing basic and diluted net loss per share

Shares used in computing

basic and diluted net loss per share

See accompanying notes.

3 unchanged sentences

THREE MONTHS ENDED

Net unrealized gain (loss) on marketable securities

SIX MONTHS ENDED

Net unrealized loss on marketable securities

Foreign currency translation adjustments

8 unchanged sentences

Other comprehensive income

Foreign currency translation adjustment

Foreign currency translation

Issuance of common stock and

14 unchanged sentences

Balance at March 31, 2023

Other comprehensive loss

Foreign currency translation

Issuance of common stock in

connection with exercise of

Stock-based compensation related

to issuance of common stock

and options in exchange

Issuance of common stock

under equity plans

Stock-based compensation for

equity-based awards to

employees and directors

Balance at June 30, 2023

GERON CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’

(IN THOUSANDS, EXCEPT SHARE DATA)

Comprehensive

2 unchanged sentences

Other comprehensive loss

Foreign currency translation adjustment

Foreign currency translation

Stock-based compensation related

5 unchanged sentences

Balance at March 31, 2022

Other comprehensive loss

Foreign currency translation

Issuance of common stock,

pre-funded warrant and

warrants to purchase

common stock in public

offering, net of issuance

costs of $ 5,066

Stock-based compensation related

to issuance of common stock

and options in exchange

Issuance of common stock

under equity plans

Stock-based compensation for

equity-based awards to

employees and directors

Balance at June 30, 2022

See accompanying notes.

2 unchanged sentences

(IN THOUSANDS)

THREE MONTHS ENDED

SIX MONTHS ENDED

Cash flows from operating activities:

20 unchanged sentences

Proceeds from exercise of warrants

Debt discount and issuance costs for debt financing

Net cash provided by financing activities

Effect of exchange rates on cash, cash equivalents and restricted cash

Net increase (decrease) in cash, cash equivalents and restricted cash

Net increase in cash, cash equivalents and restricted cash

Cash, cash equivalents and restricted cash at the beginning of the period

3 unchanged sentences

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

March 31, 2023

June 30, 2023

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

2 unchanged sentences

and “us”

as used in this report refer to Geron Corporation.

as used in this report refer to Geron Corporation and its wholly-owned subsidiaries, Geron UK Limited, or Geron UK, a United Kingdom company, and Geron Netherlands B.V., or Geron Netherlands, a Netherlands company.

Geron UK was incorporated in September 2021, and its operations commenced in January 2022.

Geron Netherlands was incorporated in February 2023, and its operations commenced in June 2023.

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X.

1 unchanged sentence

In the opinion of management, all adjustments (consisting only of normal recurring accruals) considered necessary for a fair presentation have been included.

Operating results for the three months ended March 31, 2023 are not necessarily indicative of the results that may be expected for the year ending December 31, 2023 or any other period.

Operating results for the three and six months ended June 30, 2023 are not necessarily indicative of the results that may be expected for the year ending December 31, 2023 or any other period.

These unaudited condensed consolidated financial statements and notes should be read in conjunction with the audited financial statements for each of the three years ended December 31, 2022, included in our Annual Report on Form 10-K for the year ended December 31, 2022, or the Form 10-K.

4 unchanged sentences

Principles of Consolidation

The condensed consolidated financial statements include the accounts of Geron and our wholly-owned subsidiaries, Geron UK Limited, or Geron UK, a United Kingdom company, and Geron Netherlands B.V., or Geron Netherlands, a Netherlands company.

Geron UK was incorporated in September 2021, and its operations commenced in January 2022.

Geron Netherlands was incorporated in February 2023;

however operations have not yet commenced for that entity.

Thus, there has been no financial activity for Geron Netherlands during the first quarter of 2023.

For Geron UK, we have eliminated intercompany accounts and transactions.

We prepare the financial statements of Geron UK using the local currency as the functional currency.

We translate the assets and liabilities of Geron UK at rates of exchange at the balance sheet date and translate income and expense items at average monthly rates of exchange.

The condensed consolidated financial statements include the accounts of Geron Corporation and its wholly-owned subsidiaries, Geron UK and Geron Netherlands.

For Geron UK and Geron Netherlands, we have eliminated intercompany accounts and transactions.

We prepare the financial statements of Geron UK and Geron Netherlands using the local currency as the functional currency.

We translate the assets and liabilities of Geron UK and Geron Netherlands at rates of exchange at the balance sheet date and translate income and expense items at average monthly rates of exchange.

The resultant translation adjustments are included in accumulated other comprehensive income (loss), a separate component of stockholders’

2 unchanged sentences

Basic net income (loss) per share is calculated by dividing net income (loss) by the weighted-average number of shares of common stock outstanding for the periods presented without consideration of potential common shares.

In January 2023, we entered into an underwriting agreement in connection with a public offering of our common stock, or the January 2023 offering, pursuant to which we issued a pre-funded warrant to purchase 25,000,000 shares of our common stock, or the 2023 pre-funded warrant.

In April 2022, we entered into an underwriting agreement in connection with a public offering of our common stock, or the April 2022 offering, pursuant to which we issued a pre-funded warrant to purchase 18,095,238 shares of our common stock, also known as the 2022 pre-funded warrant, together with accompanying warrants to purchase shares of our common stock.

In May 2020, we entered into an underwriting agreement in connection with a public offering of our common stock, or the May 2020 offering, pursuant to which we issued a pre-funded warrant to purchase 8,335,239 shares of our common stock, also known as the 2020 pre-funded warrant, together with accompanying warrants to purchase shares of our common stock.

The 2023 pre-funded warrant, 2022 pre-funded warrant and 2020 pre-funded warrant are exercisable immediately at an exercise price of $ 0.001 per share each and as of March 31, 2023, none of these warrants has been exercised.

We included the 2023 pre-funded warrant, 2022 pre-funded warrant and 2020 pre-funded warrant in the computation of basic net loss per share, as applicable, since their exercise price is negligible, and they may be exercised at any time.

See Note 6 on Stockholders' Equity for further discussion of the January 2023 offering.

In connection with previous public offerings, we issued pre-funded warrants to purchase shares of our common stock.

These pre-funded warrants are exercisable immediately at an exercise price of $ 0.001 per share each, and as of June 30, 2023, none of these pre-funded warrants have been exercised.

These pre-funded warrants, which represent an aggregate of 51,430,477 shares of common stock, have been included in the computation of basic net loss per share, since their exercise price is negligible and they may be exercised at any time.

Diluted net income per share would be calculated by adjusting the weighted-average number of shares of common stock outstanding for the dilutive effect of additional shares of common stock that would have been outstanding if potentially dilutive securities had been issued, as determined using the treasury-stock method.

2 unchanged sentences

Accordingly, basic and diluted net loss per share is the same for all periods presented in the accompanying condensed consolidated statements of operations.

Since we incurred a net loss for the three months ended March 31, 2023 and 2022 , the diluted net loss per share calculation excludes potential dilutive securities of 107,971,822 and 118,256,294 , respectively, related to outstanding stock options and warrants as their effect would have been anti-dilutive.

GERON CORPORATION

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

March 31, 2023

Since we incurred a net loss for the three and six months ended June 30, 2023 and 2022 , the diluted net loss per share calculation excludes potential dilutive securities of 97,584,078 and 153,703,476 , respectively, related to outstanding stock options and warrants as their effect would have been anti-dilutive.

Use of Estimates

2 unchanged sentences

GAAP requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amounts of revenues and expenses during the reporting period.

On an ongoing basis, we evaluate our estimates, including those related to accrued liabilities, revenue recognition, fair value of marketable securities, operating leases, right-of-use assets, lease liabilities, income taxes, and stock-based compensation.

On an ongoing basis, we evaluate our estimates, including those related to accrued liabilities, revenue recognition, fair value of marketable securities, operating leases, right-of-use

GERON CORPORATION

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

June 30, 2023

assets, lease liabilities, income taxes, and stock-based compensation.

We base our estimates on historical experience and on various other market specific and relevant assumptions that we believe to be reasonable under the circumstances.

5 unchanged sentences

Our marketable debt securities include U.S.

Treasury securities, municipal securities, government-sponsored enterprise securities, commercial paper and corporate notes.

Treasury securities, government-sponsored enterprise securities, commercial paper and corporate notes.

We classify our marketable debt securities as available for sale.

26 unchanged sentences

(iii) measure the transaction price, including the constraint on variable consideration;

(iv) allocate the transaction

GERON CORPORATION

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

March 31, 2023

price to the performance obligations based on stand-alone selling prices;

(iv) allocate the transaction price to the performance obligations based on stand-alone selling prices;

and (v) recognize revenue when (or as) we satisfy each performance obligation.

1 unchanged sentence

Significant management judgment is required to determine the level of effort required and the period over which completion of the performance obligations is expected under an agreement.

If reasonable estimates regarding when performance obligations are either complete or substantially complete cannot be made, then revenue recognition is deferred until a reasonable estimate can be made.

If reasonable estimates regarding when performance obligations are either complete or substantially complete cannot be made, then revenue recognition is deferred until a

GERON CORPORATION

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

June 30, 2023

reasonable estimate can be made.

Revenue is then recognized over the remaining estimated period of performance using the cumulative catch-up method.

5 unchanged sentences

License Agreements

We previously entered into several license agreements with various oncology, diagnostics, research tools and biologics production companies, whereby we granted certain rights to our non-imetelstat related technologies.

Under these agreements, non-refundable upfront fees and annual license maintenance fees were considered fixed consideration, while milestone payments and royalties were identified as variable consideration.

Since June 30, 2021, no active license agreements remain.

In connection with the divestiture of Geron’s human embryonic stem cell assets, including intellectual property and proprietary technology, to Lineage Cell Therapeutics, Inc.

16 unchanged sentences

Depreciation and Amortization

GERON CORPORATION

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

March 31, 2023

We record property and equipment at cost and calculate depreciation using the straight-line method over the estimated useful lives of the assets, generally four years .

4 unchanged sentences

We recognize stock-based compensation expense based on grant-date fair values of service-based stock options on a straight-line basis over the requisite service period, which is generally the vesting period.

For performance-based stock options with vesting based on the achievement of certain strategic milestones, stock-based compensation expense is recognized over the period from the date the performance condition is determined to be probable of occurring through the date the applicable condition is expected to be met and is reduced for estimated forfeitures, as applicable.

For performance-based stock options with vesting based on the

GERON CORPORATION

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

June 30, 2023

achievement of certain strategic milestones, stock-based compensation expense is recognized over the period from the date the performance condition is determined to be probable of occurring through the date the applicable condition is expected to be met and is reduced for estimated forfeitures, as applicable.

If the performance condition is not considered probable of being achieved, no stock-based compensation expense is recognized until such time as the performance condition is considered probable of being met, if at all.

3 unchanged sentences

We evaluate whether an adjustment to the assumptions of fair value of our common stock and historical volatility are required if observed prices of our common stock materially differ from historical information.

The following table summarizes the stock-based compensation expense included in operating expenses on our condensed consolidated statements of operations related to stock options and employee stock purchases for the three months ended March 31, 2023 and 2022, which was allocated as follows:

Three Months Ended March 31,

The following table summarizes the stock-based compensation expense included in operating expenses on our condensed consolidated statements of operations related to stock options and employee stock purchases for the three and six months ended June 30, 2023 and 2022, which was allocated as follows:

Three Months Ended June 30,

Six Months Ended June 30,

(In thousands)

1 unchanged sentence

General and administrative

Stock-based compensation expense included in operating expenses

As stock-based compensation expense recognized in our condensed consolidated statements of operations for the three months ended March 31, 2023 and 2022 is based on awards ultimately expected to vest, it has been reduced for estimated forfeitures, but at a minimum, reflects the grant-date fair value of those awards that actually vested in the period.

Stock-based compensation expense included in

operating expenses

As stock-based compensation expense recognized in our condensed consolidated statements of operations for the three and six months ended June 30, 2023 and 2022 is based on awards ultimately expected to vest, it has been reduced for estimated forfeitures, but at a minimum, reflects the grant-date fair value of those awards that actually vested in the period.

Forfeitures have been estimated at the time of grant based on historical data and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates.

We have not recognized any stock-based compensation expense for performance-based stock options on our condensed consolidated statements of operations for the three months ended March 31, 2023 and 2022, as achievement of the specified strategic milestones was not considered probable at that time.

We have not recognized any stock-based compensation expense for performance-based stock options on our condensed consolidated statements of operations for the three and six months ended June 30, 2023 and 2022, as achievement of the specified strategic milestones was not considered probable at that time.

Stock Options

2 unchanged sentences

Performance-based stock options vest upon the achievement of specified strategic milestones.

The fair value of service-based stock options granted during the three months ended March 31, 2023 and 2022 has been estimated at the date of grant using the Black Scholes option-pricing model with the following assumptions:

Three Months Ended March 31,

The fair value of service-based stock options granted during the six months ended June 30, 2023 and 2022 has been estimated at the date of grant using the Black Scholes option-pricing model with the following assumptions:

Six Months Ended June 30,

Dividend yield

6 unchanged sentences

Expected term

GERON CORPORATION

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

March 31, 2023

Employee Stock Purchase Plan

The fair value of employees’

stock purchase rights during the three months ended March 31, 2023 and 2022 has been estimated using the Black Scholes option-pricing model with the following assumptions:

Three Months Ended March 31,

stock purchase rights during the six months ended June 30, 2023 and 2022 has been estimated using the Black Scholes option-pricing model with the following assumptions:

Six Months Ended June 30,

Dividend yield

8 unchanged sentences

6 months to 12 months

GERON CORPORATION

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

June 30, 2023

Dividend yield is based on historical cash dividend payments and Geron has paid no cash dividends to date.

37 unchanged sentences

We do not expect the adoption of this standard to have a material impact on our condensed consolidated financial statements.

Other recent accounting pronouncements issued by the FASB did not or are not believed by management to have a material impact on our condensed consolidated financial statements.

GERON CORPORATION

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

March 31, 2023

Other recent accounting pronouncements issued by the FASB did not or are not believed by management to have a material impact on our condensed consolidated financial statements.

June 30, 2023

FAIR VALUE MEASUREMENTS

Cash Equivalents and Marketable Securities

Cash equivalents, restricted cash and marketable securities by security type at March 31, 2023 were as follows:

Cash equivalents, restricted cash and marketable securities by security type at June 30, 2023 were as follows:

(In thousands)

1 unchanged sentence

Money market funds

Government-sponsored enterprise securities

Commercial paper

Restricted cash:

10 unchanged sentences

Cash equivalents, restricted cash and marketable securities by security type at December 31, 2022 were as follows:

GERON CORPORATION

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

March 31, 2023

(In thousands)

15 unchanged sentences

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

March 31, 2023

Cash equivalents and marketable securities with unrealized losses that have been in a continuous unrealized loss position for less than 12 months and 12 months or longer at March 31, 2023 and December 31, 2022 were as follows:

June 30, 2023

Cash equivalents and marketable securities with unrealized losses that have been in a continuous unrealized loss position for less than 12 months and 12 months or longer at June 30, 2023 and December 31, 2022 were as follows:

Less Than 12 Months

1 unchanged sentence

(In thousands)

As of March 31, 2023:

As of June 30, 2023:

Government-sponsored enterprise

securities (due in less than one year)

Government-sponsored enterprise

securities (due in one to two years)

Commercial paper (due in less than

13 unchanged sentences

The gross unrealized losses related to U.S.

Treasury securities, municipal securities, government-sponsored enterprise securities, commercial paper and corporate notes as of March 31, 2023 and December 31, 2022 were due to changes in interest rates and not credit risk.

Treasury securities, municipal securities, government-sponsored enterprise securities, commercial paper and corporate notes as of June 30, 2023 and December 31, 2022 were due to changes in interest rates and not credit risk.

If an available-for-sale security’s fair value is less than its amortized cost basis, we evaluate whether the decline is the result of a credit loss, in which case an impairment is recorded through an allowance for credit losses.

We have not recorded any allowances for credit losses on our available-for-sale securities for the three months ended March 31, 2023 and 2022 as we have not identified any unrealized losses for these securities attributable to credit factors.

Our exposure to unrealized losses may increase in the future due to the economic pressures or uncertainties associated with local or global economic recessions as a result of the ongoing COVID-19 pandemic and ongoing geopolitical events, such as the current military conflict between Ukraine and Russia.

We have not recorded any allowances for credit losses on our available-for-sale securities for the three and six months ended June 30, 2023 and 2022 as we have not identified any unrealized losses for these securities attributable to credit factors.

Our exposure to unrealized losses may increase in the future due to the economic pressures or uncertainties associated with macroeconomic or other global economic conditions, including those resulting from inflation, rising interest rates, prospects of a recession, bank failures and other disruptions to financial systems, civil or political unrest, military conflicts, pandemics or other health crises.

Fair Value on a Recurring Basis

6 unchanged sentences

Consideration is given to the risk inherent in the valuation technique and the risk inherent in the inputs to the model.

A financial instrument’s categorization within the valuation hierarchy is based upon the lowest level of input that is significant to the fair value measurement.

Money market funds are categorized as Level 1 within the fair value hierarchy as their fair values are

GERON CORPORATION

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

March 31, 2023

based on quoted prices available in active markets.

June 30, 2023

A financial instrument’s categorization within the valuation hierarchy is based upon the lowest level of input that is significant to the fair value measurement.

Money market funds are categorized as Level 1 within the fair value hierarchy as their fair values are based on quoted prices available in active markets.

Treasury securities, municipal securities, government-sponsored enterprise securities, commercial paper, and corporate notes are categorized as Level 2 within the fair value hierarchy as their fair values are estimated by using pricing models, quoted prices of securities with similar characteristics or discounted cash flows.

The following table presents information about our financial instruments that are measured at fair value on a recurring basis as of March 31, 2023 and December 31, 2022 and indicates the fair value category assigned.

The following table presents information about our financial instruments that are measured at fair value on a recurring basis as of June 30, 2023 and December 31, 2022 and indicates the fair value category assigned.

Fair Value Measurements at Reporting Date Using

5 unchanged sentences

(In thousands)

As of March 31, 2023:

As of June 30, 2023:

Money market funds (1)(2)

18 unchanged sentences

ACCRUED LIABILITIES

Accrued liabilities consisted of the following as of March 31, 2023 and December 31, 2022:

Accrued liabilities consisted of the following as of June 30, 2023 and December 31, 2022:

(In thousands)

6 unchanged sentences

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

March 31, 2023

June 30, 2023

On September 30, 2020, we, Hercules Capital, Inc., or Hercules, and Silicon Valley Bank, a Division of First-Citizens Bank & Trust Company (successor by purchase to the Federal Deposit Insurance Corporation as receiver for Silicon Valley Bridge Bank, N.A.

2 unchanged sentences

Under the second amendment, the aggregate principal amount available to us increased from $ 75,000,000 to $ 125,000,000 , with such principal being available in a series of tranches, subject to certain terms and conditions.

As of March 31, 2023 , a total of $ 50,000,000 has been drawn under the Loan Agreement.

As of March 31, 2023, $ 55,000,000 remains as committed principal that can be drawn as follows:

As of June 30, 2023 , a total of $ 50,000,000 has been drawn under the Loan Agreement.

As of June 30, 2023, $ 55,000,000 remains as committed principal that can be drawn as follows:

(a) one tranche of $ 10,000,000 is available from January 1, 2023 until December 15, 2023 , subject to the achievement of certain clinical and regulatory milestones, and satisfaction of certain other requirements;

11 unchanged sentences

or (c) maintaining six month net product revenues of at least 70 % of net product revenues forecasted by us, should any potential Regulatory Approval for imetelstat be obtained.

We are in compliance with the covenants under the Loan Agreement as of March 31, 2023.

We are in compliance with the covenants under the Loan Agreement as of June 30, 2023.

The interest-only payment period was extended from April 2023 to April 2024 upon the achievement of positive top-line results from the IMerge Phase 3 clinical trial in January 2023.

As of March 31, 2023 , the net carrying value of the debt under the Loan Agreement was $ 51,399,000 , which includes the principal amount of $ 50,000,000 less net unamortized debt discounts and issuance costs of $ 556,000 plus accrued end of term charge of $ 1,955,000 .

The carrying value of the debt approximates the fair value as of March 31, 2023.

As of June 30, 2023 , the net carrying value of the debt under the Loan Agreement was $ 51,644,000 , which includes the principal amount of $ 50,000,000 less net unamortized debt discounts and issuance costs of $ 483,000 plus accrued end of term charge of $ 2,127,800 .

The carrying value of the debt approximates the fair value as of June 30, 2023.

The debt discounts and debt issuance costs are being amortized to interest expense over the life of the outstanding loan amounts using the effective interest rate method.

The following table presents future minimum payments, including interest and the end of term charge, under the Loan Agreement as of March 31, 2023 (in thousands):

The following table presents future minimum payments, including interest and the end of term charge, under the Loan Agreement as of June 30, 2023 (in thousands):

Remainder of 2023

6 unchanged sentences

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

March 31, 2023

June 30, 2023

CONTINGENCIES AND UNCERTAINTIES

24 unchanged sentences

The proposed settlement remains subject to final approval by the Court and certain other conditions.

As of March 31, 2023 and December 31, 2022, our portion of the settlement amount of $ 7,000,000 has been included in accrued liabilities on our condensed consolidated balance sheets.

As of June 30, 2023 and December 31, 2022, our portion of the settlement amount of $ 7,000,000 has been included in accrued liabilities on our condensed consolidated balance sheets.

Between April 23, 2020 and June 8, 2021, seven shareholder derivative actions were filed, naming as defendants certain of our current officers and certain current and former members of our board.

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On December 21, 2022, the parties in the Chancery Court Derivative Lawsuits entered into a Stipulation of Settlement, or the Derivative Stipulation, that, subject to final approval by the Chancery Court, will resolve the Chancery Court Derivative Lawsuits.

A final approval hearing regarding the Derivative Stipulation has been scheduled for May 17, 2023.

Final approval of the settlement is subject to a number of conditions and contingencies out of our control.

There can be no guarantee that all of these conditions and contingencies will occur.

Should a material condition or contingency to the settlement fail to occur, one or more of the parties to the settlement may exercise their right to terminate the settlement agreement;

On May 17, 2023, following a hearing, the Chancery Court entered an order approving the Derivative Stipulation and dismissing the Chancery Court Derivative Lawsuits with prejudice;

GERON CORPORATION

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

March 31, 2023

June 30, 2023

The consolidated shareholder derivative actions filed in the District of Delaware have been stayed pending the ruling on our motion to dismiss the Chancery Court Derivative Lawsuits.

On December 21, 2022 , the parties in the consolidated District of Delaware derivative actions entered into the Derivative Stipulation, that, subject to final approval by the Chancery Court, will resolve the consolidated District of Delaware derivative actions.

On May 30, 2023, the parties in the consolidated District of Delaware derivative actions, pursuant to the Derivative Stipulation, sought dismissal of the consolidated District of Delaware derivative actions with prejudice, which the Court granted on May 31, 2023;

The consolidated shareholder derivative actions filed in the Northern District were initially stayed through the ruling on our motion to dismiss in the consolidated securities class action lawsuit described above and then subsequently were stayed through the ruling on the lead plaintiffs’

4 unchanged sentences

On December 21, 2022, the parties in the consolidated derivative actions in the Northern District entered into the Derivative Stipulation, that, subject to final approval by the Chancery Court will resolve the consolidated derivative actions in the Northern District.

On May 30, 2023, the parties in the consolidated derivative actions in the Northern District, pursuant to the Derivative Stipulation, sought dismissal of the consolidated derivative actions in the Northern District with prejudice, which the Court granted the same day;

Our motion to dismiss the shareholder derivative action pursuant to the forum selection clause in our amended and restated bylaws was filed in the San Mateo Superior Court on August 5, 2021.

3 unchanged sentences

On December 13, 2022, the court dismissed the action without prejudice.

Under the terms of the Derivative Stipulation, in exchange for the release and dismissal with prejudice of all claims against the defendants in the consolidated shareholder derivative actions filed in the Northern District, the District of Delaware, and the Chancery Court, we agreed to pay and/or to cause our insurance carriers to pay a total of $ 1,350,000 , comprised of $ 525,000 in cash, which is payable under our available insurance coverage and $ 825,000 in cash payable by us.

The proposed settlement remains subject to final approval by the Chancery Court and certain other conditions, upon which the settlement amounts are payable.

The proposed settlement does not constitute an admission of fault or wrongdoing by our current officers or current and former members of our board.

As of March 31, 2023 and December 31, 2022, we have recorded the total settlement amount of $ 1,350,000 as accrued liabilities and $ 525,000 as interest and other receivables on our condensed consolidated balance sheets.

Under the terms of the Derivative Stipulation, in exchange for the release and dismissal with prejudice of all claims against the defendants in the consolidated shareholder derivative actions filed in the Northern District, the District of Delaware, and the Chancery Court, the parties agreed to a cash settlement of $ 1,350,000 which was accrued on our consolidated balance sheet as of December 31, 2022.

In the second quarter of 2023, our insurance carriers paid $ 525,000 in cash, and we paid $ 825,000 in cash, for an aggregate total payment of $ 1,350,000 .

The settlement does not constitute an admission of fault or wrongdoing by our current officers or current and former members of our board.

The pending lawsuits and any other related lawsuits are subject to inherent uncertainties, and the actual defense and disposition costs will depend upon many unknown factors.

2 unchanged sentences

In addition, we have and may continue to incur substantial legal fees and costs in connection with such lawsuits.

As discussed above, we have recorded the total settlement amount for the Derivative Stipulation on our condensed consolidated balance sheets as of March 31, 2023 and December 31, 2022 and our portion of the settlement amount under the Stipulation remains accrued on our condensed consolidated balance sheets as of March 31, 2023 and December 31, 2022.

We currently are not able to estimate the possible additional costs to us, if any, from these matters, and we cannot be certain how long it may take to resolve the pending lawsuits or the possible amount of any damages or legal costs that we may be required to pay.

Such amounts could be material to our condensed consolidated financial statements if we do not prevail in the defense against the pending lawsuits and any other related lawsuits, or even if we do prevail.

We have not established any reserve for any potential liability relating to the pending lawsuits and any other related lawsuits, other than settlement amounts under the Stipulation and the Derivative Stipulation.

We have not established any reserve for any potential liability relating to the pending lawsuits and any other related lawsuits, other than settlement amounts under the Stipulation.

It is possible that we could, in the future, incur judgments or enter into settlements of claims for monetary damages.

6 unchanged sentences

Severance Plan

We have an Amended and Restated Severance Plan, or Severance Plan, that applies to all employees that are (i) above the Vice President level, (ii) hired by the Company before January 1, 2022, or (iii) not subject to performance improvement plans, and provides

GERON CORPORATION

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

March 31, 2023

June 30, 2023

for, among other benefits:

(x) a severance payment upon a Change of Control Triggering Event and Separation from Service and (y) a severance payment for each non‑executive employee upon a Non‑Change of Control Triggering Event and Separation from Service.

4 unchanged sentences

The Severance Plan also provides that the provisions of employment agreements entered into between us and executive or non‑executive employees supersede the provisions of the Severance Plan.

As of March 31, 2023, all our executive officers have employment agreements with provisions that may provide greater severance benefits than those in the Severance Plan.

Risks Related to Global Economic Conditions, COVID-19 and the Military Conflict Between Ukraine and Russia

As of the date of this filing, significant uncertainty exists concerning the ultimate duration and severity of the COVID-19 pandemic and the military conflict between Ukraine and Russia.

Both of these events have caused widespread, continually evolving and unpredictable impacts on global societies, economies, financial markets and business practices.

With respect to the COVID-19 pandemic, we are closely monitoring the impact of the pandemic, the identification of new variants of the COVID-19 virus and related developments, and our focus remains on promoting employee health and safety while continuing to advance the development of imetelstat.

For both our Phase 3 clinical trials, IMerge and IMpactMF, we have limited ongoing clinical trial activity in Ukraine and Russia, but we have experienced, and may continue to experience, delays and suspensions in clinical trial activities at clinical sites in Ukraine and Russia due to the current political and civil unrest conditions.

With support from our CRO, we are monitoring the impact of the conflict on our clinical trial activities.

Due to the dynamic and unpredictable effects of the COVID-19 pandemic, we have had and expect to continue to have disruptions and/or delays in our imetelstat development program, including with respect to our ability to initiate trial sites, enroll and assess patients, maintain patient enrollment, ensure patient clinical and lab collection visits, conduct monitoring visits, supply study drug, report trial results, and interact with regulators or other important agencies due to limitations in employee resources or otherwise.

Restrictions on travel, availability of site personnel, and diversion of hospital staff and resources to COVID-19 patients, have disrupted our trial operations, as well as patient recruitment in many areas, resulting in a slowdown in patient enrollment and/or deviations from or disruptions in key clinical trial activities, such as clinical trial site initiation and monitoring.

If the effects of the COVID-19 pandemic continue and/or become more severe, we could experience significant disruptions to our clinical development timelines, delays in clinical site initiation and patient enrollment in IMpactMF, IMproveMF and IMpress, and other disruptions that could severely impact our business and the imetelstat development program.

We have taken and intend to take those actions with regard to COVID-19 that may be required by federal, state or local authorities or that we determine are in the best interests of our patients, investigators, employees and stockholders.

In response to the COVID-19 pandemic and previous “shelter in place”

and similar orders issued by state and local governments, we have allowed voluntary access to our offices in California and New Jersey to employees who have been vaccinated, and almost all of our employees continue to work remotely without any significant disruption to our business.

Our increased reliance on personnel working remotely could increase our cybersecurity risk, create data accessibility concerns and make us more susceptible to communication disruptions, any of which could adversely impact our business operations.

These and similar, and perhaps more severe, disruptions in our operations could occur which would negatively impact our business and business prospects, our financial condition and the future of imetelstat.

The effects of the COVID-19 pandemic and the military conflict between Ukraine and Russia, including the significant sanctions imposed against Russia, as well as broader economic conditions, including inflation, rising interest rates, the prospects for a recession, and recent and potential future disruptions in access to bank deposits or lending commitments due to bank failure have increased market volatility and could result in a significant long-term disruption of global financial markets, reducing or eliminating our ability to raise additional capital, which could negatively affect our liquidity, our ability to complete IMpactMF, IMproveMF and IMpress and to commence, conduct and complete any other potential future clinical trials of imetelstat.

In addition, the global economic slowdown caused by, among other things, the COVID-19 pandemic and the military conflict between Ukraine and Russia, as well as inflation, rising interest rates, the prospects for a recession, and recent and potential future disruptions in access to bank

GERON CORPORATION

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

March 31, 2023

deposits or lending commitments due to bank failures could materially and adversely affect our business and the value of our common stock.

The extent to which global economic conditions, including those resulting from the COVID-19 pandemic, the military conflict between Ukraine and Russia and recent and potential future bank failures, ultimately impact our business, our regulatory and clinical development activities, clinical supply chain and other business operations, as well as the value of and market for our common stock, will depend on future developments that are highly uncertain and cannot be predicted with confidence at this time, such as the ultimate duration and severity of the pandemic, travel restrictions, quarantines, social distancing and business closure requirements in the U.S.

and in other countries, the effectiveness of actions taken globally to contain and treat COVID-19, whether the military conflict between Ukraine and Russia resolves in a timely manner, or at all, and whether the U.S.

and/or international banking system stabilizes despite recent and any potential future bank failures.

As of June 30, 2023, all our executive officers have employment agreements with provisions that may provide greater severance benefits than those in the Severance Plan.

Risks Related to Global Economic, Political and Health Conditions

Our business is subject to various risks and uncertainties, including risks and uncertainties associated with macroeconomic or other global economic conditions, including those resulting from inflation, rising interest rates, prospects of a recession, bank failures and other disruptions to financial systems, civil or political unrest, military conflicts, pandemics or other health crises and supply chain and resource issues.

Occurrences of such events have caused and may cause in the future and unpredictable impacts on global societies, economies, financial markets and business practices.

Specifically for our business, such risks and uncertainties have adversely affected and may continue to adversely affect our ability to:

continue to develop imetelstat or advance imetelstat to subsequent clinical trials, including receiving regulatory approval for or to commercialize imetelstat, on a timely basis or at all;

conduct and complete current imetelstat clinical trials on a timely basis or at all;

establish sales, marketing and distribution capabilities, or obtain coverage and adequate third-party payor reimbursement, to successfully commercialize imetelstat, if regulatory approval is obtained;

open clinical sites or recruit, enroll and retain patients in current or future clinical trials of imetelstat;

manufacture and supply imetelstat in adequate quantities that meet specifications that may be approved or required by regulatory authorities and on timelines necessary for current and potential future clinical trials and potential commercial uses;

execute on our business strategy and/or our operations by our employees without any restrictions;

obtain additional capital to continue the development of imetelstat in current and any potential future clinical trials of imetelstat, and establish potential future imetelstat commercialization efforts.

The extent to which macroeconomic or other global economic conditions, including those resulting from inflation, rising interest rates, prospects of a recession, bank failures and other disruptions to financial systems, civil or political unrest, military conflicts, pandemics or other health crises and supply chain and resource issues, ultimately impact our business, our regulatory and clinical development activities, clinical supply chain and other business operations, as well as the value of and market for our common stock, will depend on future developments that are highly uncertain and cannot be predicted with confidence.

Accordingly, we do not yet know the full extent of potential delays or impacts on our business, our regulatory and clinical development activities, clinical supply chain and other business operations or the global economy as a whole.

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The 2023 pre-funded warrant has an exercise price of $ 0.001 per share and may be exercised at any time until the 2023 pre-funded warrant is exercised in full.

As of March 31, 2023 , none of the 2023 pre-funded warrant has been exercised.

The net cash proceeds from this offering were $ 213,337,000 , after deducting the underwriting discount and other offering expenses paid by us, and exclude any future proceeds from the exercise of the 2023 pre-funded warrant.

As of June 30, 2023, none of the 2023 pre-funded warrant has been exercised.

The net cash proceeds from this offering were $ 213,337,000 , after deducting

GERON CORPORATION

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

June 30, 2023

the underwriting discount and other offering expenses paid by us, and exclude any future proceeds from the exercise of the 2023 pre-funded warrant.

Upon the issuance of the 2023 pre-funded warrant, we evaluated the terms of each warrant to determine the appropriate accounting and classification pursuant to FASB Accounting Standards Codification Topic 480, Distinguishing Liabilities from Equity , and FASB Accounting Standards Codification Topic 815, Derivatives and Hedging .

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In the first quarter of 2023, warrants to purchase 44,983,194 shares of Geron common stock were exercised for net cash proceeds of approximately $ 59,835,000 .

In the second quarter of 2023, warrants to purchase 12,842,857 shares of Geron common stock were exercised for net cash proceeds of approximately $ 17,767,000 .

The warrants were issued in connection with underwritten public offerings of common stock and pre-funded warrants, together with accompanying stock purchase warrants in May 2020 and April 2022.

As of March 31, 2023, the following warrants remained outstanding:

pre-funded warrants with an exercise price of $ 0.001 per shares to purchase 51,430,477 shares of our common stock;

stock purchase warrants with an exercise price of $ 1.30 per share to purchase 8,174,503 shares of our common stock related to the May 2020 offering;

stock purchase warrants with an exercise price of $ 1.45 per share to purchase 26,666,669 shares of our common stock related to the April 2022 offering.

As of June 30, 2023, the following warrants remained outstanding:

pre-funded warrants with an exercise price of $ 0.001 per share to purchase 51,430,477 shares of our common stock;

stock purchase warrants with an exercise price of $ 1.30 per share to purchase 2,474,503 shares of our common stock related to the public offering of our common stock in May 2020;

stock purchase warrants with an exercise price of $ 1.45 per share to purchase 19,523,812 shares of our common stock related to the public offering of our common stock in April 2022.

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

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and patients classified as Low or Intermediate-1 risk according to the International Prognostic Scoring System, or IPSS.

Based on the positive top-line data from IMerge Phase 3 and the prior IMerge Phase 2, we plan to submit a New Drug Application, or NDA, to the FDA in the United States, or U.S., in mid-2023 and a marketing authorization application, or MAA, in Europe in the second half of 2023 for the use of imetelstat in adult patients with lower risk MDS.

If the NDA is accepted for filing and imetelstat is approved for commercialization by the FDA within the timelines we expect, we anticipate commercial launch of imetelstat in lower risk MDS in the U.S.

Based on the positive top-line data from IMerge Phase 3 and the prior IMerge Phase 2, we submitted a New Drug Application, or NDA, to the FDA in the United States, or U.S., for the treatment of transfusion-dependent anemia in adult patients with low-to-intermediate-1 risk MDS who have failed to respond or have lost response to or are ineligible for erythropoiesis-stimulating agents, or ESAs, in June 2023 and plan to submit a marketing authorization application, or MAA, in Europe in the fourth quarter of 2023.

If the NDA is accepted for filing and imetelstat is approved for commercialization by the FDA in a timely manner, we anticipate commercial launch of imetelstat in lower risk MDS in the U.S.

could occur in the first half of 2024.

In Europe, we anticipate review of the planned MAA, if validated by the European Medicines Agency, or EMA, could take approximately 14 months and, if approved, we anticipate that the commercial launch of imetelstat in lower risk MDS in Europe could occur by the end of 2024.

We believe that the positive top-line data from IMerge Phase 3 and IMerge Phase 2, as well as our prior Phase 2 clinical trial of imetelstat in patients with Intermediate-2 or High-Risk myelofibrosis who have relapsed after or are refractory to treatment with a janus associate kinase inhibitor, or JAK inhibitor, or relapsed/refractory MF, provide strong evidence that imetelstat targets telomerase to inhibit the uncontrolled proliferation of malignant stem and progenitor cells enabling recovery of bone marrow and normal blood cell production, which suggest potential disease-modifying activity.

We believe that the positive data from IMerge Phase 3 and IMerge Phase 2, as well as our prior Phase 2 clinical trial of imetelstat in patients with Intermediate-2 or High-Risk myelofibrosis who have relapsed after or are refractory to treatment with a janus associate kinase inhibitor, or JAK inhibitor, or relapsed/refractory MF, provide strong evidence that imetelstat targets telomerase to inhibit the uncontrolled proliferation of malignant stem and progenitor cells enabling recovery of bone marrow and normal blood cell production, which suggest potential disease-modifying activity.

We believe this potential for disease modification could differentiate imetelstat from currently approved treatments in myeloid hematologic malignancies.

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IMpactMF, a Phase 3 clinical trial in relapsed/refractory MF with overall survival, or OS, as the primary endpoint, that currently is enrolling patients.

Based on our planning assumptions for enrollment and event (death) rates in the trial, we expect the interim analysis for OS in IMpactMF may occur in 2024, and the final analysis may occur in 2025.

Because these analyses are event-driven and it is uncertain whether actual rates for enrollment and events will reflect current planning assumptions, the results may be available at different times than currently expected.

IMproveMF, a Phase 1 combination clinical trial in first-line Intermediate-1, Intermediate-2 or High-Risk myelofibrosis, or frontline MF, that currently is enrolling patients and the first patient was dosed in April 2021;

IMpress, an investigator-led Phase 2 clinical trial in Intermediate-2 or High-Risk myelodysplastic syndromes, or higher risk MDS, and acute myeloid leukemia, or AML, with the initial clinical site planned to open in 2023.

Current Status of Phase 3 Clinical Trials

IMerge Phase 3 in Lower Risk MDS

The trial has been extended to allow remaining patients to continue to receive treatment of either imetelstat or placebo.

In addition, patients are being followed for survival and disease progression, which allows us to continue to assess the longer-term durability of transfusion independence, as well as survival, disease progression and safety.

Further data and analyses from longer patient follow up is expected to be presented at future medical meetings.

IMpact MF in Relapsed/Refractory MF

As of March 31, 2023, 150 of 176 selected sites were open for patient enrollment.

Additional site selection and site openings are ongoing.

Several recruitment initiatives are being conducted, as well as more engagement with investigators through on site visits or interactions at medical meetings.

Based on our current planning assumptions for enrollment and event (death) rates in the trial, we now expect the interim analysis for OS in IMpactMF may occur in the first half of 2025, and the final analysis may occur in the first half of 2026.

Because these analyses are event-driven and it is uncertain whether actual rates for

enrollment and events will reflect current planning assumptions, the results may be available at different times than currently expected.

IMpress, an investigator-led Phase 2 clinical trial in Intermediate-2 or High-Risk myelodysplastic syndromes, or higher risk MDS, and acute myeloid leukemia, or AML, in which the first patient was dosed in June 2023.

In June 2023, we opened an expanded access program, sometimes called compassionate use, whereby imetelstat could be used outside of a clinical trial for lower risk MDS patients with serious or life-threatening conditions who have exhausted their treatment options and are not eligible for, or able to participate in, a clinical trial.

To be considered for expanded access, requests must be submitted to Geron by a qualified and licensed physician with expertise and facilities appropriate for the administration of imetelstat.

Recently Reported New Data from IMerge Phase 3

In June 2023, we reported new data and analyses from IMerge Phase 3 in at the European Hematology Association 2023 Hybrid Congress, or the EHA presentation.

We believe these data expand on the potential differentiating qualities of imetelstat to address current unmet needs for lower risk MDS patients.

Key highlights of each presentation are summarized as follows:

Presentation:

Continuous Transfusion Independence with Imetelstat in Heavily Transfused Non-Del(5q) Lower Risk Myelodysplastic Syndromes Relapsed/Refractory to Erythropoiesis Stimulating Agents in IMerge Phase 3

This oral presentation reported top-line results from IMerge Phase 3 with a data cut-off of October 2022 for the primary analysis and a data cut-off of January 2023 for ≥1-yr transfusion independence, or TI.

As reported in January 2023, imetelstat demonstrated statistically significant and clinically meaningful efficacy results in the trial, with robust 8-week TI, 24-week TI, and 1-year TI rates, as noted in the figure below.

In the trial, 39.8% (47/118) of imetelstat-treated patients versus 15.0% (9/60) of placebo-treated patients achieved 8-week TI (P < 0.001).

In addition, the rate of 8-week TI was also significantly higher for imetelstat-treated patients versus placebo-treated patients across MDS subgroups, including in RS negative and RS positive patients.

Median TI duration using Kaplan Meier estimates (95% CI) was 51.6 (26.9–83.9) weeks for imetelstat-treated patients versus 13.3 (8.0–24.9) weeks for placebo-treated patients (P < 0.001).

Key secondary endpoint of 24-week TI was achieved in 28.0% (33/118) of imetelstat-treated patients versus 3.3% (2/60) of placebo-treated patients receiving (P < 0.001).

With 3 months additional follow-up, 17.8% (21/118) of imetelstat-treated patients versus 1.7% (1/60) of placebo-treated patients achieved 1-year TI (P = 0.002), representing 63.6% of 24-week TI imetelstat responders.

Two new analyses presented at EHA on TI responses by subgroups underscored the breadth of potential effect of imetelstat vs.

The first analysis reported higher durability of TI for imetelstat-treated patients vs.

placebo across MDS subgroups:

Durability of RBC-TI for 8-Week TI Responders Across Key LR MDS Subgroups

median, weeks (95% CI)

51.6 (26.9–83.9)

13.3 (8.0–24.9)

0.23 (0.09–0.57)

46.9 (25.9–83.9)

16.9 (8.0–24.9)

0.32 (0.11–0.95)

51.6 (11.9–NE)

11.2 (10.1–NE)

0.11 (0.01–1.43)

Prior RBC transfusion burden per IWG 2006

4–6 units/8 weeks

51.9 (24.9–122.9)

16.9 (10.1–24.9)

0.35 (0.13–0.96)

6 units/8 weeks

39.9 (15.9–NE)

8.4 (8.0–NE)

0.04 (0.003–0.48)

IPSS risk category

43.9 (25.0–NE)

15.1 (8.0–24.9)

0.26 (0.10–0.68)

Intermediate-1

51.6 (11.9–NE)

10.1 (NE–NE)

0.15 (0.01–2.47)

Baseline sEPO

≤500 mU/mL

51.6 (26.9–83.9)

13.3 (8.0–24.9)

0.21 (0.075–0.61)

122.9 (8.14–NE)

14.6 (12.3–NE)

0.34 (0.03–3.85)

Prior ESA use

43.9 (26.9–80.0)

13.3 (8.0–24.9)

0.26 (0.10–0.72)

122.9 (8.14–NE)

14.6 (12.3–NE)

0.34 (0.03–3.85)

___________________

October 13, 2022.

Hazard ratio (95% CI) from the Cox proportional hazard model, stratified by prior RBC transfusion burden (≥4 to ≤6 vs >6 RBC units/8 weeks during a 16-week period prior to randomization) and baseline IPSS risk category (low vs intermediate-1), with treatment as the only covariate.

P -value (2-sided) for superiority of imetelstat vs placebo in hazard ratio based on stratified log-rank test.

ESA, erythropoiesis-stimulating agent;

IPSS, International Prognostic Scoring System;

IWG, International Working Group;

LR-MDS, lower-risk myelodysplastic syndromes;

NE, not estimable;

RBC, red blood cell;

RS, ring sideroblast;

sEPO, serum erythropoietin;

TI, transfusion independence.

The second analysis reported higher 24-week TI for imetelstat-treated patients vs.

placebo across MDS subgroups:

Comparable 24-Week RBC-TI Rate Across Key LR MDS Subgroups

33/118 (28.0)

24.6 (12.64–34.18)

27.5 (10.00–40.37)

20.5 (-0.03–35.75)

Prior RBC transfusion burden per IWG 2006

4–6 units/8 weeks

24.6 (5.68–38.66)

>6 units/8 weeks

25.0 (6.44–38.65)

IPSS risk category

23.6 (7.23–35.75)

Intermediate-1

26.3 (3.46–43.39)

Baseline sEPO

≤500 mU/mL

27.8 (10.46–39.71)

15.4 (-5.81–35.73)

Prior ESA use

31/108 (28.7)

24.9 (11.61–35.00)

20.0 (-23.47–55.78)

_____________

October 13, 2022.

As previously reported in January 2023 with top-line results from the trial, the safety profile observed with imetelstat in IMerge Phase 3 was consistent with prior clinical experience with no new safety signals.

The EHA presentation provided new data on the consequences of the grade 3-4 thrombocytopenia and neutropenia which were most often reported during treatment Cycles 1-3 and led to dose modifications.

While approximately 50% of patients treated with imetelstat had dose reductions due to treatment emergent adverse events (TEAE), less than 15% of patients discontinued treatment due to TEAE.

Discontinuation of imetelstat treatment in

these patients due to a TEAE generally occurred late in treatment, with a median time to treatment discontinuation of 21.1 (range 2.3 to 44.0) weeks.

Presentation:

Disease Modifying Activity of Imetelstat in Patients with Heavily Transfused Non-Del(5q) Lower Risk Myelodysplastic Syndromes Relapsed/Refractory to Erythropoiesis Stimulating Agents in IMerge Phase 3

This oral presentation reported new data on cytogenetic responses and reductions in bone marrow RS from IMerge Phase 3.

In lower risk MDS, malignant clones carrying cytogenetic abnormalities, mutant alleles, or both arise from malignant stem and progenitor cells in the bone marrow.

Specifically, SF3B1, involved in RNA splicing, and TET2, involved in DNA methylation, are recurrently mutated genes in lower risk MDS, which can be quantified by measuring change in variant allele frequency, or VAF, to denote disease burden.

Of the 178 patients enrolled in IMerge Phase 3, 22.0% of imetelstat-treated patients and 21.7% of placebo-treated patients had baseline cytogenetic abnormalities.

Cytogenetic response was observed in 34.6% (9/26) of imetelstat treated patients (95% CI=17.2–55.7) versus 15.4% (2/13) of placebo-treated patients (95% CI=1.9–45.5).

In addition, a higher percentage of patients treated with imetelstat (40.8%) vs.

placebo (9.7%) had a ≥50% reduction in central bone marrow RS.

TI responses were enriched in patients achieving a ≥50% reduction in central bone marrow RS.

Furthermore, the EHA presentation provided updated data on variant allele frequency (VAF) reductions and new analyses on the correlation of such reductions with clinical responses which provides further evidence of the potential disease-modifying activity of imetelstat.

As shown below, reductions in VAF of genes frequently mutated in MDS were greater for imetelstat-treated patients than placebo:

SF3B1 (P< 0.001), TET2 (P= 0.032), DNMT3A (P= 0.019) and ASXL1 (P=0.146).

More patients treated with imetelstat vs.

placebo had ≥50% VAF reduction in these mutations.

For patients with the SF3B1 mutation, 29.5% (23/78) of those treated with imetelstat vs.

2.6% (1/38) on placebo (P= 0.001) had a ≥50% VAF reduction.

Imetelstat treatment resulted in sustained reduction of SF3B1 VAF over time.

In the imetelstat group, 82.6% (19/23) of patients had 8-week TI among patients who achieved ≥50% maximum reduction from baseline in SF3B1 VAF vs.

38.1% (21/55) of those who did not.

Similarly, a larger proportion of TI responders were imetelstat-treated patients achieving ≥50% reduction in TET2 VAF.

In the imetelstat group, 83.3% (10/12) of patients had 8-week RBC-TI among patients who achieved ≥50% maximum reduction from baseline in TET2 VAF vs 43.5% (10/23) of those who did not.

As shown below, a larger proportion of 8-week and 24-week TI responders were imetelstat-treated patients achieving ≥50% reduction in SF3B1 and TET2 VAF.

VAF reduction in SF3B1, TET2 and DNMT3A correlated with longer TI duration and increases in hemoglobin levels in imetelstat-treated patients.

Further, 8-week and 24-week TI correlated with reduction in RS+ cells, cytogenetic responses and VAF reduction.

Presentation Title:

Analysis of Patient Reported Fatigue in IMerge Phase 3 Trial of Imetelstat vs.

Placebo in Heavily Transfused Non-Del(5q) Lower Risk Myelodysplastic Syndromes Relapsed/Refractory to Erythropoiesis Stimulating Agents (ESA)

This poster presentation described results from an exploratory analysis from IMerge Phase 3 of patient reported fatigue conducted using Functional Assessment of Chronic Illness Therapy, or FACIT, a validated 13-item patient questionnaire.

Proportion of sustained meaningful deterioration/improvement was defined as percentage of patients with ≥3-point decrease/increase on the FACIT Fatigue Scale (0–52) for ≥2 consecutive nonmissed treatment cycles.

Time-to-deterioration/improvement was estimated by Kaplan-Meier analysis.

In IMerge Phase 3, 118 patients on imetelstat and 57 patients on placebo were assessed for patient reported fatigues.

Completion rates for the FACIT questionnaire were >85% at most visits throughout the study in both groups.

The proportion of patients who experienced any episode of sustained, meaningful deterioration in fatigue during the trial was 43.2% for imetelstat-treated patients and 45.6% for placebo-treated patients with imetelstat-treated patients receiving fewer transfusion units over time.

For patients treated with imetelstat, there was a numerically higher percentage of patients reporting any episode of sustained meaningful improvement in fatigue.

Overall, 50.0% of imetelstat-treated patients reported sustained meaningful improvement in fatigue versus 40.4% of placebo-treated patients.

In addition, imetelstat-treated patients reported a shorter median time to first sustained meaningful improvement in fatigue versus placebo-treated patients;

28.3 vs 65.0 weeks, respectively, hazard ratio=1.34 (95% CI, 0.82–2.20).

As shown in the figures below, after 12 weeks, more imetelstat-treated patients reported improvement in the FACIT Fatigue Scale than placebo-treated patients.

In addition, in imetelstat-treated patients, a significantly higher proportion of TI responders had sustained meaningful improvement in fatigue scores versus non-responders.

This was consistent across 8-week TI and 24-week TI and hematologic improvement-erythroid, or HI-E, response per 2006 International Working Group criteria, for imetelstat-treated patients, which was not an association observed in placebo-treated patients.

Additional analysis showed that patients experiencing grade 3 or 4 neutropenia or thrombocytopenia had the same rates of sustained meaningful improvement in fatigue (52.5% and 53.4%, respectively) as the total imetelstat population (50%).

Financial Overview

Since our inception, we have primarily financed our operations through the sale of equity securities, interest income on our marketable securities and payments we received under our collaborative and licensing arrangements.

As of March 31, 2023, we had approximately $409.2 million in cash, cash equivalents, restricted cash and marketable securities and a long-term principal debt balance of $50.0 million.

As of June 30, 2023, we had approximately $400.2 million in cash, cash equivalents, restricted cash and marketable securities and a long-term principal debt balance of $50.0 million.

Substantially all of our revenues to date have been payments under collaboration agreements, and milestones, royalties and other revenues from our licensing arrangements.

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We have incurred significant net losses since our inception in 1990, resulting principally from costs incurred in connection with our research and development activities and from general and administrative costs associated with our operations.

As of March 31, 2023, we had an accumulated deficit of approximately $1.5 billion.

As of June 30, 2023, we had an accumulated deficit of approximately $1.5 billion.

The significance of future losses, future revenues and any potential future profitability will depend primarily on the clinical and commercial success of imetelstat, our sole product candidate.

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commercialization of imetelstat lower risk MDS.

Based on our current operating plan and our expectations regarding the timing of the submission and potential acceptance and approval of our planned NDA by the FDA for imetelstat in lower risk MDS and the potential commercialization in the U.S.

for the use of imetelstat in adult patients with lower risk MDS, we believe that our existing cash, cash equivalents, restricted cash and current and noncurrent marketable securities will be sufficient to fund our projected operating requirements through the end of the third quarter of 2025, which includes potential U.S.

commercial launch of imetelstat in lower risk MDS in the first half of 2024.

In the absence of potential proceeds from exercises of currently outstanding warrants and potential drawdowns under the Loan Agreement, we will require substantial additional funding to further advance the imetelstat program, including through the completion of IMpactMF, IMproveMF and IMpress, as well as conducting the clinical, regulatory and potential commercialization activities necessary to potentially bring imetelstat to market in relapsed/refractory MF and any other future indications, and our need for additional funds may arise sooner than planned.

We cannot predict with any certainty whether and to what extent the outstanding warrants will be exercised for cash, or the timing or availability of additional funds under the Loan Agreement, if at all.

Based on our current operating plan and our expectations regarding the timing of potential acceptance and approval of our NDA by the FDA for imetelstat for the treatment of transfusion-dependent anemia in adult patients with lower risk MDS, who have failed to respond to or have lost response to or are ineligible for ESAs, we believe that our existing cash, cash equivalents, restricted cash and current and noncurrent marketable securities will be sufficient to fund our projected operating requirements through the end of the third quarter of 2025, which includes estimated revenues from a potential U.S.

commercial launch of imetelstat in lower risk MDS in the first half of 2024 and the revised timing expectations for interim and final analyses in IMpactMF.

In the absence of potential additional proceeds from exercises of remaining outstanding warrants and potential drawdowns under the Loan Agreement, we will require substantial additional funding to further advance the imetelstat program, including through the completion of IMpactMF, IMproveMF and IMpress, as well as conducting the clinical, regulatory and potential commercialization activities necessary to potentially bring imetelstat to market in relapsed/refractory MF and any other future indications, and our need for additional funds may arise sooner than planned.

We cannot predict with any certainty whether and to what extent the remaining outstanding warrants will be exercised for cash, or the timing or availability of additional funds under the Loan Agreement, if at all.

If approved for marketing by regulatory authorities outside of the U.S., we may seek potential commercialization partners for such territories.

Until the FDA or similar international regulatory authorities approve imetelstat for marketing in lower risk MDS, if at all, we cannot begin commercialization.

Note on the COVID-19 Pandemic and Military Conflict Between Ukraine and Russia

The ongoing COVID-19 pandemic is having widespread, continually evolving, and unpredictable impacts on global societies, economies, financial markets, and business practices.

We are closely monitoring the impact of the pandemic, the identification of new variants of the COVID-19 virus and related developments, and our focus remains on promoting employee health and safety while

continuing to advance the development of imetelstat.

For a discussion regarding the effect of the ongoing COVID-19 pandemic and the military conflict between Ukraine and Russia on our business and financial results, see the section entitled “Risk Factors”

in Part II, Item 1A and Note 5 on Contingencies and Uncertainties –

Risks Related to Global Economic Conditions, COVID-19 and the Military Conflict Between Ukraine and Russia in Notes to Condensed Consolidated Financial Statements of this quarterly report on Form 10-Q.

CRITICAL ACCOUNTING POLICIES AND ESTIMATES

There have been no significant changes in our critical accounting policies and estimates during the three months ended March 31, 2023, as compared to the critical accounting policies and estimates disclosed in our 2022 Form 10-K.

There have been no significant changes in our critical accounting policies and estimates during the six months ended June 30, 2023, as compared to the critical accounting policies and estimates disclosed in our 2022 Form 10-K.

Our condensed consolidated financial statements have been prepared in accordance with U.S.

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The preparation of these financial statements requires management to make estimates and assumptions that affect the reported assets and liabilities and disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amounts of revenues and expenses during the reporting period.

Note 1 on Summary of Significant Accounting Policies in Notes to Condensed Consolidated Financial Statements of this quarterly report on Form 10-Q describes the significant accounting policies used in the preparation of the condensed consolidated financial statements.

Note 1 on Summary of

Significant Accounting Policies in Notes to Condensed Consolidated Financial Statements of this quarterly report on Form 10-Q describes the significant accounting policies used in the preparation of the condensed consolidated financial statements.

Estimates and assumptions about future events and their effects cannot be determined with certainty.

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the uncertain and unpredictable drug research and discovery process;

overcoming disruptions and/or delays due to the COVID-19 pandemic or geopolitical events, such as the current military conflict between Ukraine and Russia;

overcoming disruptions and/or delays due to macroeconomic or other global conditions, such as inflation, rising interest rates, prospects of a recession, bank failures and other disruptions to financial systems, civil or political unrest, military conflicts, pandemics or other health crises and supply chain and resource issues;

our need for substantial additional capital;

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which acquired Asterias Biotherapeutics, Inc.) in 2013, we are entitled to receive royalties on sales from certain research or commercial products utilizing Geron’s divested intellectual property.

We recognized royalty revenues of $21,000 for the three months ended March 31, 2023, compared to $123,000 for the same period in 2022.

We recognized royalty revenues of $29,000 and $50,000 for the three and six months ended June 30, 2023, respectively, compared to $73,000 and $196,000 for the same periods in 2022.

Royalty revenues in 2023 and 2022 primarily reflect estimated royalties from sales of cell-based research products from our divested stem cell assets.

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Historical revenues may not be predictive of future revenues.

We expect royalty revenues in 2023 to be comparable to 2022 from sales of cell-based research products from our divested stem cell assets.

We expect royalty revenues in 2023 to be lower than in 2022 from sales of cell-based research products from our divested stem cell assets.

Research and Development Expenses

During the three months ended March 31, 2023 and 2022, our imetelstat program and our research discovery program related to potential next generation telomerase inhibitors were the only research and development programs we supported.

During the three and six months ended June 30, 2023 and 2022, our imetelstat program and our research discovery program related to potential next generation telomerase inhibitors were the only research and development programs we supported.

For these research and development programs, we incur direct external, personnel-related and other research and development costs.

For the three months ended March 31, 2023 and 2022, direct external expenses included costs for our CROs, consultants and other clinical-related vendors, as well as expenses for contract manufacturing and quality activities.

For the three and six months ended June 30, 2023 and 2022, direct external expenses included costs for our CROs, consultants and other clinical-related vendors, as well as expenses for contract manufacturing and quality activities.

Personnel-related expenses primarily consist of salaries and wages, stock-based compensation, payroll taxes and benefits for our employees involved with ongoing research and development efforts.

Other research and development expenses primarily consist of research-related overhead associated with allocated expenses for rent and maintenance of facilities and other supplies.

Research and development expenses for the three months ended March 31, 2023 and 2022 were as follows:

Three Months Ended March 31,

Research and development expenses for the three and six months ended June 30, 2023 and 2022 were as follows:

Three Months Ended June 30,

Six Months Ended June 30,

(In thousands)

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Total research and development expenses

The increase in research and development expenses for the three months ended March 31, 2023, compared to the same period in 2022, primarily reflects the net result of increased personnel-related expenses for additional headcount and higher clinical trial costs related to supporting IMerge Phase 3 and IMpactMF;

partially offset by decreased manufacturing costs due to the timing of imetelstat manufacturing batches.

The increase in research and development expenses for the three and six months ended June 30, 2023, compared to the same periods in 2022, primarily reflects the net result of higher manufacturing costs due to the timing of imetelstat manufacturing batches, increased personnel-related expenses for additional headcount, and higher clinical trial costs related to supporting IMerge Phase 3 and IMpactMF.

We expect research and development expenses to increase in the future as we conduct and complete ongoing clinical trials of imetelstat.

At this time, we cannot provide reliable estimates of how much time or investment will be necessary to advance imetelstat toward commercialization.

For a more complete discussion of the risks and uncertainties associated with the development of imetelstat, see the sub‑sections entitled “Risks Related to the Development of Imetelstat”

For a more complete discussion of the risks and uncertainties associated with the development of

imetelstat, see the sub‑sections entitled “Risks Related to the Development of Imetelstat”

and “Risks Related to Regulatory Compliance Matters and Commercialization of Imetelstat”

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General and Administrative Expenses

General and administrative expenses were $12.9 million for the three months ended March 31, 2023, compared to $6.7 million for the same period in 2022.

The increase in general and administrative expenses for the three months ended March 31, 2023, compared to the same period in 2022, primarily reflects new costs for commercial preparatory activities of approximately $1.7 million;

and higher personnel-related expenses of approximately $3.5 million for additional headcount.

General and administrative expenses were $16.5 million and $29.4 million for the three and six months ended June 30, 2023, respectively, compared to $7.4 million and $14.1 million for the same periods in 2022.

The increase in general and administrative expenses for the three and six months ended June 30, 2023, compared to the same periods in 2022, primarily reflects higher personnel-related expenses of approximately $4.8 million and $8.4 million, respectively, for additional headcount;

as well as new costs for commercial preparatory activities of approximately $2.4 million and $4.1 million, respectively.

We expect general and administrative expenses to increase in the future as the imetelstat program matures and potential stage-gated commercialization activities continue.

Interest Income

Interest income was $3.9 million for the three months ended March 31, 2023, compared to $112,000 for the same period in 2022.

The increase in interest income for the three months ended March 31, 2023, compared to the same period in 2022, primarily reflects a larger marketable securities portfolio with the receipt of net cash proceeds from the underwritten public offering completed in January 2023, as well as higher yields from recent marketable securities purchases.

Interest income was $4.7 million and $8.6 million for the three and six months ended June 30, 2023, respectively, compared to $330,000 and $442,000 for the same periods in 2022.

The increase in interest income for the three and six months ended June 30, 2023, compared to the same periods in 2022, primarily reflects a larger marketable securities portfolio with the receipt of net cash proceeds from the underwritten public offering completed in January 2023 and cash proceeds from warrant exercises in the first half of 2023, as well as higher yields from recent marketable securities purchases.

Interest earned in future periods will depend on the size of our marketable securities portfolio and prevailing interest rates.

See Note 6 on Stockholders' Equity in Notes to Condensed Consolidated Financial Statements of this quarterly report on Form 10-Q for additional information about the underwritten public offering completed in January 2023.

Interest Expense

Interest expense was $1.9 million for the three months ended March 31, 2023, compared to $1.5 million for the same period in 2022.

The increase in interest expense for the three months ended March 31, 2023, compared to the same period in 2022, primarily reflects rising interest rates.

Interest expense was $2.0 million and $3.9 million for the three and six months ended June 30, 2023, respectively, compared to $1.6 million and $3.1 million for the same periods in 2022.

The increase in interest expense for the three and six months ended June 30, 2023, compared to the same periods in 2022, primarily reflects rising interest rates.

Currently, we have $50.0 million in principal debt outstanding.

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Other Income and (Expense), Net

Net other income was $39,000 for the three months ended March 31, 2023 and net other expense was $56,000 for the three months ended March 31, 2022.

Net other expense was $11,000 for the three months ended June 30, 2023 and net other income was $28,000 for the six months ended June 30, 2023, compared to net other income of $1.1 million for the three and six months ended June 30, 2022.

Net other income and expense primarily reflects bank charges related to our cash operating accounts and marketable securities portfolio and foreign currency transaction adjustments.

LIQUIDITY AND CAPITAL RESOURCES

As of March 31, 2023, we had cash, restricted cash, cash equivalents, and marketable securities of $409.2 million, compared to $173.1 million at December 31, 2022.

The increase in cash, restricted cash, cash equivalents and marketable securities during the three months ended March 31, 2023 was primarily the net result of the receipt of net cash proceeds of $213.3 million from our underwritten public offering completed in January 2023 and receipt of cash proceeds from exercise of outstanding warrants of $59.8 million, partially offset by cash being used for operations.

As of June 30, 2023, we had cash, restricted cash, cash equivalents, and marketable securities of $400.2 million, compared to $173.1 million at December 31, 2022.

The increase in cash, restricted cash, cash equivalents and marketable securities during the six months ended June 30, 2023 was primarily the net result of the receipt of net cash proceeds of $213.3 million from our underwritten public offering completed in January 2023 and receipt of cash proceeds from exercise of outstanding warrants of $77.6 million, partially offset by cash being used for operations.

On January 10, 2023, we completed an underwritten public offering of 68,007,741 shares of our common stock and a pre-funded warrant to purchase 25,000,000 shares of our common stock, or the 2023 pre-funded warrant.

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Equity in Notes to Condensed Consolidated Financial Statements of this quarterly report on Form 10-Q for additional information about the underwritten public offering completed in January 2023.

From January 1, 2023 through March 31, 2023, we have received $46.7 million in cash proceeds from the exercise of the 2020 purchase warrants, representing 35,935,576 shares of our common stock.

From January 1, 2023 through March 31, 2023, we have received $13.1 million in cash proceeds from the exercise of the 2022 purchase warrants, representing 9,047,617 shares of our common stock.

As of March 31, 2023, we had a long-term principal debt balance of $50.0 million under the Loan Agreement with Hercules and SVB.

From January 1, 2023 through June 30, 2023, we have received $54.1 million in cash proceeds from the exercise of warrants we issued in 2020, covering 41,635,576 shares of our common stock.

From January 1, 2023 through June 30, 2023, we have received $23.5 million in cash proceeds from the exercise of warrants we issued in 2022, covering 16,190,474 shares of our common stock.

As of June 30, 2023, we had a long-term principal debt balance of $50.0 million under the Loan Agreement with Hercules and SVB.

In June 2022, we entered into a second amendment to the Loan Agreement with Hercules and SVB.

Under the second amendment, the aggregate principal amount available to us increased from $75.0 million to $125.0 million.

As of March 31, 2023, a total of $55.0 million is available to be drawn in a series of tranches under the Loan Agreement, subject to certain terms and conditions.

Of this amount, $30.0 million is available subject to our achievement of certain clinical and regulatory milestones and satisfaction of certain capitalization and other requirements, and the remaining $25.0 million is available subject to approval by an investment committee comprised of Hercules and SVB (First-Citizens Bank & Trust Company as of March 27, 2023).

As of June 30, 2023, a total of $55.0 million is available to be drawn in a series of tranches under the Loan Agreement, subject to certain terms and conditions.

Of this amount, $30.0 million is available subject to our achievement of certain clinical and regulatory milestones and

satisfaction of certain capitalization and other requirements, and the remaining $25.0 million is available subject to approval by an investment committee comprised of Hercules and SVB.

See Note 4 on Debt in Notes to Condensed Consolidated Financial Statements of this quarterly report on Form 10-Q for additional information on the second amendment.

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Riley Securities under the 2020 Sales Agreement.

We did not sell any shares of our common stock pursuant to the 2020 Sales Agreement during the three months ended March 31, 2023.

Approximately $79.1 million of our common stock remained available for issuance under the 2020 Sales Agreement as of March 31, 2023.

We did not sell any shares of our common stock pursuant to the 2020 Sales Agreement during the six months ended June 30, 2023.

Approximately $79.1 million of our common stock remained available for issuance under the 2020 Sales Agreement as of June 30, 2023.

The 2020 Sales Agreement will expire upon the earlier of:

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Future Funding Requirements

commercial launch of imetelstat in lower risk MDS in the first half of 2024.

Based on our current operating plan and our expectations regarding the timing of the potential acceptance and approval of our NDA by the FDA for imetelstat for the treatment of transfusion-dependent anemia in adult patients with lower risk MDS who have failed to respond to or have lost response to or are ineligible for ESAs, we believe that our existing cash, cash equivalents, restricted cash and current and noncurrent marketable securities will be sufficient to fund our projected operating requirements through the end of the third quarter of 2025, which includes estimated revenues potential U.S.

commercial launch of imetelstat in lower risk MDS in the first half of 2024 and the revised timing expectations for interim and final analyses in IMpactMF.

In the absence of potential additional proceeds from exercises of currently remaining warrants and potential drawdowns under the Loan Agreement, we will require substantial additional funding to further advance the imetelstat program, including through the completion of IMpactMF, IMproveMF and IMpress, as well as conducting the clinical, regulatory and potential commercialization activities necessary to potentially bring imetelstat to market in relapsed/refractory MF and any other future indications, and our need for additional funds may arise sooner than planned.

We cannot predict with any certainty whether and to what extent the outstanding remaining warrants will be exercised for cash, or the timing or availability of additional funds under the Loan Agreement, if at all.

In addition, our ability to commercialize imetelstat in the U.S., if regulatory approval is granted, depends on us being able to establish sales and marketing capabilities which we may be unable to do in a timely manner or at all.

Because the outcome of any clinical activities and/or regulatory approval process is highly uncertain, we cannot reasonably estimate whether any development activities we may undertake will succeed, whether we will be able to commercialize imetelstat, and we may never recoup our investment in any imetelstat development, which would adversely affect our financial condition and our business and business prospects, and might cause us to cease operations.

In addition, our plans and timing expectations could be further delayed or interrupted by macroeconomic conditions, such as if COVID-19 or pandemic conditions worsen, creating further limitations on our clinical trial or commercial preparatory activities, or if U.S.

and/or international banking system fails to stabilize in light of recent and potential future bank failures, or could be disrupted by civil or political unrest or military conflicts around the world, such as the current military conflict between Ukraine and Russia.

Because the outcome of any clinical activities and/or regulatory approval process is highly uncertain, we cannot reasonably estimate whether any development activities we may undertake will succeed;

whether we will obtain regulatory approval for imetelstat in any indication we pursue, including lower risk MDS;

or whether we will be able to effectively commercialize imetelstat, if at all.

We may never recoup our investment in any imetelstat development which would adversely affect our financial condition and our business and business prospects, and might cause us to cease operations.

In addition, our plans and timing expectations could be further delayed or interrupted by the effects of macroeconomic or other global conditions, including those resulting from inflation, rising interest rates, prospects of a recession, bank failures and other disruptions to financial systems, civil or political unrest, military conflicts, pandemics or other health crises and supply chain and resource issues.

Further, our future capital requirements are difficult to forecast and will depend on many factors, including:

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the scope, progress, timing, magnitude and costs of clinical development, manufacturing and potential commercialization of imetelstat, including the number of indications being pursued, subject to clearances and approvals by the FDA and similar international regulatory authorities;

the scope, progress, duration, results and costs of current clinical trials, including IMerge Phase 3, IMpactMF, IMproveMF and IMpress, and any potential future clinical trials of imetelstat, as well as non-clinical studies and assessments of imetelstat;

delays or disruptions in opening sites, screening and enrolling patients or treating and following patients, in IMpactMF, IMproveMF, IMpress, or any potential future clinical trials of imetelstat, whether as a result of the effects of macroeconomic conditions like the COVID-19 pandemic, or civil or political unrest or military conflicts around the world, such as the military conflict between Ukraine and Russia;

the scope, progress, duration, results and costs of current clinical trials, including IMerge Phase 3, IMpactMF, IMproveMF and IMpress, and any potential future clinical trials of imetelstat, as well as our recently opened expanded access program and non-clinical studies and assessments of imetelstat;

delays or disruptions in opening sites, screening and enrolling patients or treating and following patients, in IMpactMF, IMproveMF, IMpress, or any potential future clinical trials of imetelstat, whether as a result of the effects of macroeconomic or other global conditions, including those resulting from inflation, rising interest rates, prospects of a recession, bank failures and other disruptions to financial systems, civil or political unrest, military conflicts, pandemics or other health crises and supply chain and resource issues;

the costs, timing and outcomes of regulatory reviews or other regulatory actions related to imetelstat, such as obtaining and maintaining regulatory clearances and approvals to continue clinical development of imetelstat in current and potential future clinical trials, as well as to commence potential commercialization of imetelstat in the U.S.

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the costs of multiple third-party vendors and service providers, including our CROs and third-party manufacturers, to pursue the development, manufacturing and potential commercialization of imetelstat;

our ability to establish, enforce and maintain collaborative or other strategic arrangements for research, development, clinical testing and manufacturing of imetelstat on favorable terms, if at all;

our ability to establish, enforce and maintain collaborative or other strategic arrangements for the research, development, clinical testing and manufacturing of imetelstat on favorable terms, if at all;

our efforts to enhance operational, financial and management processes and systems that will be required for future development and commercialization of imetelstat, and our ability to successfully recruit and retain additional key personnel to support the development and potential future commercialization of imetelstat;

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the success of any collaborations that we may enter into with third parties;

expenses associated with settlement of the pending securities class action lawsuits, and the ongoing derivative lawsuits, as well as any other potential litigation;

expenses associated with settlement of the pending securities class action lawsuits, as well as any other potential litigation;

the extent and scope of our general and administrative expenses, including expenses associated with potential future litigation;

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the costs of maintaining and operating facilities in California and New Jersey, telecommunications and administrative oversight, as well as higher expenses for travel;

broader economic conditions, including inflation, rising interest rates, the prospects for a recession, and recent and potential future disruptions in access to bank deposits or lending commitments due to bank failure, that may reduce our ability to access debt capital or financing on preferable terms, which may adversely affect future capital requirements and forecasts;

macroeconomic or other global conditions, including those resulting from inflation, rising interest rates, the prospects of a recession, bank failure and other disruptions to financial systems, civil or political unrest, military conflicts, pandemics or other health crises and supply chain and resource issues, that may reduce our ability to access debt capital or financing on preferable terms, which may adversely affect future capital requirements and forecasts;

the costs of enabling our personnel to work remotely, including providing supplies, equipment and technology necessary for them to perform their responsibilities;

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Availability of such financing sources may be negatively impacted by any further delays in reporting results from IMpactMF or investors’

perception of top-line results from IMerge Phase 3, despite our interpretation of such data being positive, as well as factors such as the global economic slowdown, inflation, rising interest rates and the prospects for a recession, as well as recent and potential future disruptions in access to bank deposits or lending commitments due to bank failure.

perception of top-line results from IMerge Phase 3, despite our interpretation of such data being positive, as well as macroeconomic or other global conditions, including those resulting from inflation, rising interest rates, prospects or a recession, bank failures and other disruptions to financial systems, civil or political unrest, military conflicts, pandemics or other health crises and supply chain and resource issues.

Additional financing through public or private debt or equity financings, including pursuant to the 2020 Sales Agreement with B.

Riley Securities, Inc., or B.

Riley, the remaining tranches of up to $55.0 million available under the Loan Agreement, which are subject to the achievement of certain clinical and regulatory milestones and satisfaction of certain capitalization and other requirements, as well as approval by an investment committee comprised of Hercules and SVB (First-Citizens Bank & Trust Company as of March 27, 2023) for the final $25.0 million tranche;

capital lease transactions or other financing sources, may not be available on acceptable terms, or at all.

We may be unable to raise equity capital, or may be forced to do so at a stock price or on other terms that could result in substantial dilution of ownership for our stockholders.

The receptivity of the public and private debt and equity markets to proposed financings has been substantially affected by uncertainty in the general economic, market and political climate due to the effects of macroeconomic conditions like the COVID-19 pandemic, civil or political unrest or military conflicts around the world, such as the military conflict between Ukraine and Russia, inflation, rising interest rates, prospects of a recession, or recent and potential future disruptions in access to bank deposits or lending commitments due to bank failure, and may in the future be affected by other factors which are unpredictable and over which we have no control.

In this regard, the effects of the COVID-19 pandemic have increased market volatility and could result in a significant long-term disruption of global financial markets, which

could reduce or eliminate our ability to raise additional funds through financings, and could negatively impact the terms upon which we may raise those funds.

The receptivity of the public and private debt and equity markets to proposed financings has been substantially affected by uncertainty in the general economic, market and political climate due to the effects of macroeconomic or other global conditions, such as inflation, rising interest rates, prospects of a recession, bank failures and other disruptions to financial systems, civil or political unrest, military conflicts, pandemics or other health crises and supply chain and resource issues, and may in the future be affected by other factors which are unpredictable and over which we have no control.

These effects have increased market volatility and could result in a significant long-term disruption of global financial markets, which could reduce or eliminate our ability to raise additional funds through financings, and could negatively impact the terms upon which we may raise those funds.

Similarly, these macroeconomic conditions have created extreme volatility and disruption in the capital markets and is expected to have further global economic consequences.

If the equity and credit markets deteriorate, including as a result of macroeconomic conditions like the COVID-19 pandemic, civil or political unrest or military conflicts around the world, such as the military conflict between Ukraine and Russia, inflation, rising interest rates, prospects of a recession or recent and potential future disruptions in access to bank deposits or lending commitments due to bank failure, it may make any necessary debt or equity financing more difficult to obtain in a timely manner or on favorable terms, more costly or more dilutive.

If the equity and credit markets deteriorate, including as a result of macroeconomic or other global conditions, such as inflation, rising interest rates, prospects of a recession, bank failures and other disruptions to financial systems, civil or political unrest, military conflicts, pandemics or other health crises and supply chain and resource issues, it may make any necessary debt or equity financing more difficult to obtain in a timely manner or on favorable terms, more costly or more dilutive.

If we are unable to raise additional capital or establish alternative collaborative arrangements with third-party collaborative partners for imetelstat, the development and potential commercialization of imetelstat may be further delayed, altered or abandoned, which might cause us to cease operations.

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Moreover, if we raise additional funds through alliance, collaborative or licensing arrangements with third parties, we may have to relinquish valuable rights to imetelstat or our technologies or grant licenses on terms that are not favorable to us.

We cannot assure you that our existing capital resources, including net cash proceeds from our recent underwritten public offering in January 2023, future interest income, future proceeds from potential cash exercises of currently outstanding warrants and potential future sales of our common stock, including under the 2020 Sales Agreement with B.

Riley or potential future drawdowns, if available, of the remaining up to $55.0 million under the Loan Agreement (which are subject to the achievement of certain clinical and regulatory milestones and satisfaction of certain capitalization and other requirements, as well as approval by an investment committee comprised of Hercules and SVB (First-Citizens Bank & Trust Company as of March 27, 2023) for the final $25.0 million tranche), will be sufficient to fund our operating plans.

We cannot assure you that our existing capital resources, future interest income, future proceeds from potential cash exercises of currently outstanding warrants, potential future sales of our common stock, including under the 2020 Sales Agreement with B.

Riley and potential future drawdowns, if available, of the remaining up to $55.0 million under the Loan Agreement (which are subject to the achievement of certain clinical and regulatory milestones and satisfaction of certain capitalization and other requirements, as well as approval by an investment committee comprised of Hercules and SVB for the final $25.0 million tranche), will be sufficient to fund our operating plans.

While we did not hold cash deposits or securities at SVB, if other banks and financial institutions enter receivership, become insolvent or otherwise fail in the future in response to financial conditions affecting the banking system and financial markets or otherwise, our ability to access our existing cash, cash equivalents and marketable securities may be delayed or precluded, which could have a material adverse effect on our business, business prospects and financial position.

Cash Flows from Operating Activities

Net cash used in operations for the three months ended March 31, 2023 and 2022 was $46.4 million and $34.0 million, respectively.

The increase in net cash used in operations for the three months ended March 31, 2023, compared to the same period in 2022, primarily reflects higher payments to support ongoing clinical trials of imetelstat, commercial preparatory activities, and increases in headcount to support pre-approval and commercialization efforts.

Net cash used in operations for the six months ended June 30, 2023 and 2022 was $76.0 million and $62.6 million, respectively.

The increase in net cash used in operations for the six months ended June 30, 2023, compared to the same period in 2022, primarily

reflects higher payments to support ongoing clinical trials of imetelstat, commercial preparatory activities, and increases in headcount to support pre-approval and commercialization efforts.

Cash Flows from Investing Activities

Net cash used in investing activities was $178.7 million for the three months ended March 31, 2023 and net cash provided by investing activities was $30.4 million for the three months ended March 31, 2022.

The increase in net cash used in investing activities for the three months ended March 31, 2023, compared to the same period in 2022, primarily reflects a higher rate of purchases than maturities of marketable securities in 2023 from the investment of net cash proceeds received from the underwritten public offering completed in January 2023 and warrant exercises in the first quarter of 2023.

Net cash used in investing activities was $223.2 million for the six months ended June 30, 2023 and net cash provided by investing activities was $33.2 million for the six months ended June 30, 2022.

The increase in net cash used in investing activities for the six months ended June 30, 2023, compared to the same period in 2022, primarily reflects a higher rate of purchases than maturities of marketable securities in 2023 from the investment of net cash proceeds received from the underwritten public offering completed in January 2023 and warrant exercises in the first half of 2023.

Cash Flows from Financing Activities

Net cash provided by financing activities for the three months ended March 31, 2023 and 2022 was $281.0 million and none, respectively.

Financing activities in 2023 primarily reflect the receipt of net cash proceeds from the underwritten public offering completed in January 2023 and warrant exercises in the first quarter of 2023.

Net cash provided by financing activities for the six months ended June 30, 2023 and 2022 was $299.4 million and $70.6 million, respectively.

Financing activities in 2023 primarily reflect the receipt of net cash proceeds from the underwritten public offering completed in January 2023 and warrant exercises in the first half of 2023.

Contractual Obligations

We have entered into arrangements that contractually obligate us to make payments that will affect our liquidity and cash flows in future periods.

Our contractual obligations primarily consist of our current and noncurrent debt obligations under the Loan Agreement with Hercules and SVB (First-Citizens Bank & Trust Company as of March 27, 2023), as described above and in Note 4 on Debt in Notes to Condensed Consolidated Financial Statements of this quarterly report on Form 10-Q, and obligations under

non-cancellable operating leases.

The aggregate amount of our future operating lease payments was reported in our 2022 Form 10-K and there have been no changes to the contractual terms of our operating leases during the three months ended March 31, 2023.

Our contractual obligations primarily consist of our current and noncurrent debt obligations under the Loan Agreement with Hercules and SVB, as described above and in Note 4 on Debt in Notes to Condensed Consolidated Financial Statements of this quarterly report on Form 10-Q, and obligations under non-cancellable operating leases.

In the normal course of business, we enter into agreements with CROs for clinical trials and third-party manufacturers for clinical supply manufacturing and with other vendors for non-clinical research studies, investigator-led trials and other services and products for operating purposes.

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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-Q

Item 1. Financial Statements