What changed in this filing

/stocks — the workspaceLOADING

Item 1. Financial Statements

2023-11-02 compared with 2023-08-03 · 229 added, 344 removed, 719 unchanged (44% of the section changed)

3 unchanged sentences

(IN THOUSANDS)

SEPTEMBER 30,

Current assets:

29 unchanged sentences

THREE MONTHS ENDED

SIX MONTHS ENDED

NINE MONTHS ENDED

SEPTEMBER 30,

Operating expenses:

14 unchanged sentences

THREE MONTHS ENDED

SIX MONTHS ENDED

NINE MONTHS ENDED

SEPTEMBER 30,

Net unrealized loss on marketable securities

39 unchanged sentences

Balance at June 30, 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 September 30, 2023

GERON CORPORATION

30 unchanged sentences

Balance at June 30, 2022

Other comprehensive loss

Foreign currency translation

Stock-based compensation

related to issuance of common

stock and options in exchange

Issuance of common stock in

connection with exercise of

Issuances of common stock

under equity plans

Stock-based compensation for

equity-based awards to

employees and directors

Balance at September 30, 2022

See accompanying notes.

2 unchanged sentences

(IN THOUSANDS)

SIX MONTHS ENDED

NINE MONTHS ENDED

SEPTEMBER 30,

Cash flows from operating activities:

29 unchanged sentences

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

June 30, 2023

SEPTEMBER 30, 2023

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

8 unchanged sentences

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 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.

Operating results for the three and nine months ended September 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.

13 unchanged sentences

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 are exercisable immediately at an exercise price of $ 0.001 per share each, and as of September 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.

3 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 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.

Since we incurred a net loss for the three and nine months ended September 30, 2023 and 2022 , the diluted net loss per share calculation excludes potential dilutive securities of 77,651,673 and 174,347,456 , respectively, related to outstanding stock options and warrants as their effect would have been anti-dilutive.

Use of Estimates

5 unchanged sentences

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

June 30, 2023

SEPTEMBER 30, 2023

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

42 unchanged sentences

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

June 30, 2023

SEPTEMBER 30, 2023

reasonable estimate can be made.

33 unchanged sentences

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

June 30, 2023

SEPTEMBER 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.

4 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 and six months ended June 30, 2023 and 2022, which was allocated as follows:

Three Months Ended June 30,

Six Months Ended June 30,

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 nine months ended September 30, 2023 and 2022, which was allocated as follows:

Three Months Ended September 30,

Nine Months Ended September 30,

(In thousands)

3 unchanged sentences

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.

As stock-based compensation expense recognized in our condensed consolidated statements of operations for the three and nine months ended September 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 and six months ended June 30, 2023 and 2022, as achievement of the specified strategic milestones was not considered probable at that time.

We recognized stock-based compensation expense of $ 3.2 million related to performance-based stock options on our condensed consolidated statements of operations for the three and nine months ended September 30, 2023, as we achieved a specified strategic milestone associated with certain performance-based stock options.

We have not recognized any additional stock-based compensation expense for any remaining performance-based stock options on our condensed consolidated statements of operations for the three and nine months ended September 30, 2023 and 2022, as achievement of the specified strategic milestones associated with the remaining performance-based stock options 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 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,

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

Nine Months Ended September 30,

Dividend yield

6 unchanged sentences

Expected term

GERON CORPORATION

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

SEPTEMBER 30, 2023

Employee Stock Purchase Plan

The fair value of employees’

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,

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

Nine Months Ended September 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

June 30, 2023

SEPTEMBER 30, 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.

FAIR VALUE MEASUREMENTS

Cash Equivalents and Marketable Securities

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

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

(In thousands)

1 unchanged sentence

Money market funds

Commercial Paper

Restricted cash:

2 unchanged sentences

Marketable securities:

Treasury securities - due in 1 to 2 years

Government-sponsored enterprise

6 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

SEPTEMBER 30, 2023

(In thousands)

15 unchanged sentences

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

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:

SEPTEMBER 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 September 30, 2023 and December 31, 2022 were as follows:

Less Than 12 Months

1 unchanged sentence

(In thousands)

As of June 30, 2023:

As of September 30, 2023:

US Treasury Securities (due in less than one year)

Government-sponsored enterprise

17 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 June 30, 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 September 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 and six months ended June 30, 2023 and 2022 as we have not identified any unrealized losses for these securities attributable to credit factors.

We have not recorded any allowances for credit losses on our available-for-sale securities for the three and nine months ended September 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.

5 unchanged sentences

Inputs (other than quoted market prices included in Level 1) are either directly or indirectly observable for the asset or liability through correlation with market data at the measurement date and for the duration of the instrument’s anticipated life.

Inputs reflect management’s best estimate of what market participants would use in pricing the asset or liability at the measurement date.

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

GERON CORPORATION

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

June 30, 2023

SEPTEMBER 30, 2023

Inputs reflect management’s best estimate of what market participants would use in pricing the asset or liability at the measurement date.

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.

1 unchanged sentence

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 June 30, 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 September 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 June 30, 2023:

As of September 30, 2023:

Money market funds (1)(2)

Certificate of deposit (2)

Treasury securities (3)

Government-sponsored enterprise

15 unchanged sentences

(4) Included in noncurrent portion of marketable securities on our condensed consolidated balance sheets.

GERON CORPORATION

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

SEPTEMBER 30, 2023

ACCRUED LIABILITIES

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

Accrued liabilities consisted of the following as o f September 30, 2023 and December 31, 2022:

SEPTEMBER 30,

(In thousands)

4 unchanged sentences

Interest payable

GERON CORPORATION

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

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 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:

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

As of September 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 June 30, 2023.

We are in compliance with the covenants under the Loan Agreement as of September 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 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.

As of September 30, 2023 , the net carrying value of the debt under the Loan Agreement was $ 51,898,000 , which includes the principal amount of $ 50,000,000 less net unamortized debt discounts and issuance costs of $ 408,000 plus accrued end of term charge

GERON CORPORATION

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

SEPTEMBER 30, 2023

of $ 2,306,000 .

The carrying value of the debt approximates the fair value as of September 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 June 30, 2023 (in thousands):

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

Remainder of 2023

4 unchanged sentences

Noncurrent portion of debt

GERON CORPORATION

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

June 30, 2023

CONTINGENCIES AND UNCERTAINTIES

3 unchanged sentences

The other two lawsuits, filed in the U.S.

District Court, or the Court, for the Northern District of California, or the Northern District, were consolidated by the Court on May 14, 2020, and on August 20, 2020, the lead plaintiffs filed a consolidated class action complaint.

The consolidated class action complaint alleges violations of the Securities Exchange Act of 1934, as amended, or the Exchange Act, in connection with allegedly false and misleading statements made by us related to IMbark during the period from March 19, 2018, to September 26, 2018.

The consolidated class action complaint alleges, among other things, that we violated Sections 10(b) and 20(a) of the Exchange Act and SEC Rule 10b-5 by failing to disclose facts related to the alleged failure of IMbark to meet the two primary endpoints of the trial, spleen response rate and Total Symptom Score, and that our stock price dropped when such information was disclosed.

The plaintiffs in the consolidated class action complaint seek damages and interest, and an award of reasonable costs, including attorneys’

On October 22, 2020, lead plaintiffs filed an amended consolidated class action complaint.

We filed a motion to dismiss the amended consolidated class action complaint on November 23, 2020.

On April 12, 2021, the Court granted in part and denied in part our motion to dismiss.

Our answer to the amended consolidated class action complaint was filed on May 13, 2021.

On September 30, 2021, lead plaintiffs filed their motion for class certification, and on April 2, 2022, the Court granted the lead plaintiffs’

motion for class certification.

On September 2, 2022 , the parties agreed to a settlement and entered into a Stipulation and Agreement of Settlement, or the Stipulation, which is subject to Court approval.

District Court, or the Court, for the Northern District of California, or the Northern District, were consolidated by the Court on May 14, 2020.

On September 2, 2022 , the parties agreed to a settlement and entered into a Stipulation and Agreement of Settlement, or the Stipulation, which was subject to Court approval.

Under the terms of the Stipulation, in exchange for the release and dismissal with prejudice of all claims against the defendants in the consolidated class action complaint, we agreed to pay and/or to cause our insurance carriers to pay a total of $ 24,000,000 , comprised of $ 17,000,000 in cash, which was paid into an escrow account under our available insurance coverage and, at our election, $ 7,000,000 in either shares of our common stock and/or cash which was payable after final approval of the settlement by the Court.

On October 13, 2022, the Court preliminarily approved the parties’

settlement, and permitted notice to be distributed to the class members.

On March 30, 2023, the Court held a hearing on the motion for final approval of settlement and plan of allocation and ordered supplemental notice be sent to all of the class members.

A second final approval hearing is scheduled for August 24, 2023.

Final approval of the settlement by the Court 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 both of the parties to the settlement may exercise their right to terminate the settlement agreement.

Under the terms of the Stipulation, in exchange for the release and dismissal with prejudice of all claims against the defendants in the consolidated class action complaint, we agreed to pay and/or to cause our insurance carriers to pay a total of $ 24,000,000 , comprised of $ 17,000,000 in cash, which was paid into an escrow account under our available insurance coverage and, at our election, $ 7,000,000 in either shares of our common stock and/or cash which is payable after final approval of the settlement by the Court.

The proposed settlement does not constitute an admission of fault or wrongdoing by Geron or our Chief Executive Officer.

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

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.

Of these actions, or the Derivative Lawsuits, two were filed in the Northern District, two were filed in the Court of Chancery of the State of Delaware, or the Chancery Court, two were filed in the U.S.

District Court for the District of Delaware, or the District of Delaware, and one was filed in the Superior Court of California for the County of San Mateo, or the San Mateo Superior Court, respectively.

The plaintiffs in the Derivative Lawsuits allege breach of fiduciary duty and/or violations of Section 14 of the Exchange Act, based on the same underlying facts as the consolidated class action lawsuit described above.

The plaintiffs seek damages, corporate governance reforms, equitable relief, restitution, and an award of reasonable costs, including attorneys’

The status of the seven Derivative Lawsuits is currently as follows:

On July 2, 2021, we filed a motion to dismiss the consolidated shareholder derivative actions filed in the Chancery Court, or the Chancery Court Derivative Lawsuits.

On September 1, 2021, the plaintiffs filed a consolidated amended complaint in the Chancery Court Derivative Lawsuits.

On October 12, 2021, we filed our motion to dismiss the consolidated amended complaint.

The Chancery Court heard oral argument on the motion on February 15, 2022, and, on June 22, 2022, issued an order staying its decision on our motion to dismiss until after final resolution of the consolidated class action lawsuit described above.

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.

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

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’

motion for class certification in the consolidated securities class action lawsuit.

Subsequent to the grant of class certification in the consolidated securities class action lawsuit, on May 3, 2022, the Northern District entered an order providing plaintiffs until June 7, 2022, to file an amended complaint.

On June 7, 2022, plaintiffs filed an amended shareholder derivative complaint.

On July 6, 2022, the Northern District entered an order staying the consolidated shareholder derivative actions filed in the Northern District until the earlier of either a public announcement of a settlement in the consolidated securities class action lawsuit or a final, non-appealable judgment in the consolidated securities class action lawsuit.

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.

At the hearing on the motion to dismiss on November 2, 2021, the court granted our motion to dismiss and stayed the case until April 19, 2022.

At the case management conference on April 19, 2022, the court continued the stay until June 14, 2022.

At the case management conference on June 14, 2022, the court continued the stay until December 13, 2022.

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, the parties agreed to a cash settlement of $ 1,350,000 which was accrued on our consolidated balance sheet as of December 31, 2022.

settlement, and the Court granted final approval of the settlement on September 28, 2023 and final judgment was entered on October 3, 2023.

As of September 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.

The settlement amount was paid in the first week of October 2023.

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

On May 17, 2023, the Delaware Court of Chancery approved a settlement of the derivative case pending before it, and the case was dismissed with prejudice.

Subsequently, each of the remaining derivative cases were dismissed with prejudice as well.

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.

The outcome of the pending lawsuits and any other related lawsuits is necessarily uncertain.

We could be forced to expend significant resources in the defense against the pending lawsuits and any other related lawsuits, and we may not prevail.

Any other future lawsuits are subject to inherent uncertainties, and the actual defense and disposition costs will depend upon many unknown factors.

The outcome of any other future lawsuits is necessarily uncertain.

We could be forced to expend significant resources in the defense against any other future lawsuits, and we may not prevail.

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

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.

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 any future lawsuit.

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

We have not established any reserve for any potential liability relating to any future lawsuits.

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

GERON CORPORATION

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

SEPTEMBER 30, 2023

Indemnifications to Officers and Directors

5 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

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.

3 unchanged sentences

Severance payments range from three to 18 months of base salary, depending on the employee’s position with us, payable in a lump sum payment.

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

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 Severanc e Plan.

As of September 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

9 unchanged sentences

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.

GERON CORPORATION

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

SEPTEMBER 30, 2023

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.

7 unchanged sentences

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 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.

As of September 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 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 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 .

In the third quarter of 2023, warrants to purchase 19,523,808 shares of Geron common stock were exercised for net cash and receivables of approximately $ 28,309,522 .

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 June 30, 2023, the following warrants remained outstanding:

As of September 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.

2023 At Market Issuance Sales Agreement

On November 1, 2023, we entered into an At Market Issuance Sales Agreement, or the 2023 Sales Agreement with B.

Riley Securities, Inc., or B.

Riley Securities, pursuant to which we may issue and sell shares of our common stock having an aggregate offering price of up to $ 100 million from time to time through B.

Riley Securities as the sales agent.

The issuance and sale of common stock under the 2023 Sales Agreement will be pursuant our effective shelf registration

statement on Form S-3 filed with the United States Securities and Exchange Commission, or the SEC, on January 4, 2023.

Riley Securities may sell the common stock by any method that is deemed an “at the market offering”

as defined in Rule 415

promulgated under the Securities Act of 1933, as amended.

Subject to the terms and conditions of the 2023 Sales Agreement, B.

Securities will use commercially reasonable efforts consistent with its normal trading and sales practices to sell our common stock

from time to time, based upon our instructions (including any price, time or size limits or other customary parameters or conditions we

We are not obligated to make any sales of common stock under the 2023 Sales Agreement.

We will pay B.

Riley Securities an aggregate commission rate equal to up to 3.0 % of the gross proceeds of the sales price per

share for common stock sold through B.

Riley Securities under the 2023 Sales Agreement.

We have also provided B.

Riley Securities

with customary indemnification rights.

Unless earlier terminated as provided below, the 2023 Sales Agreement will automatically terminate upon earlier of (i) the sale

GERON CORPORATION

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

SEPTEMBER 30, 2023

of all common stock subject to the 2023 Sales Agreement or (ii) termination of the 2023 Sales Agreement in accordance with its terms.

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

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and “Management’s Discussion and Analysis of Financial Condition and Results of Operations”

contained in our Form 10-K for the year ended December 31, 2022, as filed with the United States Securities and Exchange Commission, or SEC, on March 16, 2023, or 2022 Form 10-K.

contained in our Form 10-K for the year ended December 31, 2022, as filed with the SEC on March 16, 2023, or 2022 Form 10-K.

Company Overview

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Our investigational first-in-class telomerase inhibitor, imetelstat, harnesses Nobel Prize winning science in a treatment that may alter the underlying course of these diseases.

Our lead indication for imetelstat is in Low or Intermediate-1 risk myelodysplastic syndromes, or lower risk MDS.

Our lead program for imetelstat is in Low or Intermediate-1 risk myelodysplastic syndromes, or lower risk MDS.

In January 2023, we reported positive top-line results from our IMerge Phase 3 clinical trial.

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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 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.

Consistent with prior imetelstat clinical experience, the most common serious adverse events were primarily short-lived, manageable thrombocytopenia and neutropenia.

Based on the positive top-line data from IMerge Phase 3 and the prior IMerge Phase 2 clinical trials, 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, which was accepted for standard review in August 2023 and assigned a Prescription Drug User Fee Act (PDUFA) action date of June 16, 2024.

In addition, the FDA informed us that it is currently planning to hold an advisory committee meeting as part of the NDA review.

If 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 by the end of the first half of 2024.

In September 2023, we submitted a marketing authorization application, or MAA, in Europe that was validated for review by the European Medicines Agency, or EMA, for imetelstat for the same proposed indication as in the U.S.

We anticipate review of the MAA could take approximately 14 months and, if approved by the European Commission by the end of 2024, we anticipate that the commercial launch of imetelstat in lower risk MDS in Europe could occur in 2025.

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.

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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 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.

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 with respect to which we expect early data at the end of 2023;

Based on our current planning assumptions for enrollment and event (death) rates in the trial, we 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.

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.

In October 2023, the Safety Evaluation Team (SET) for the study evaluated patient data from the first cohort.

No dose-limiting toxicities (DLTs) were identified, and the SET made a unanimous decision to escalate to the second dose cohort, effective immediately;

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.

In June 2023, we opened an expanded access program, sometimes called a compassionate use program, whereby imetelstat can 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 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.

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

As of September 30, 2023, we had approximately $381.9 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 June 30, 2023, we had an accumulated deficit of approximately $1.5 billion.

As of September 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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We expect research and development expenses, general and administrative expenses, and losses to substantially increase in future periods as we continue to support the imetelstat development program, including the conduct and completion of IMpactMF, IMproveMF and IMpress, as well as the potential U.S.

commercialization of imetelstat lower risk MDS.

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.

and European commercialization of imetelstat in lower risk MDS.

Based on our current operating plan and our expectations regarding the timing of potential approval of our NDA by the FDA for imetelstat for the treatment of transfusion-dependent anemia in adult patients with lower risk MDS, we believe that our existing cash, cash equivalents, and current and noncurrent marketable securities, together with projected revenues from U.S.

sales of imetelstat, proceeds from the exercise of our outstanding warrants, and funding under the Loan Agreement, will be sufficient to fund our projected operating requirements through the end of the third quarter of 2025.

Our ability to generate revenues from sales of imetelstat in the U.S., if regulatory approval is granted, depends on us being able to establish sales and marketing capabilities and gain acceptance in the marketplace, which we may be unable to do in a timely manner or at all.

In addition, 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.

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.

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

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CRITICAL ACCOUNTING POLICIES AND ESTIMATES

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.

There have been no significant changes in our critical accounting policies and estimates during the nine months ended September 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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In order for imetelstat to be commercialized, we must conduct non-clinical tests and clinical trials to demonstrate the safety and efficacy of imetelstat, obtain regulatory approvals or clearances and enter into manufacturing, distribution and marketing arrangements, as well as obtain market acceptance.

We do not expect to receive revenue based on sales of imetelstat for several years, if at all.

We do not expect to receive revenue based on sales of imetelstat for the current year, if at all.

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

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 $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.

We recognized royalty revenues of $164,000 and $214,000 for the three and nine months ended September 30, 2023, respectively, compared to $297,000 and $493,000 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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Research and Development Expenses

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.

During the three and nine months ended September 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 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.

For the three and nine months ended September 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 and six months ended June 30, 2023 and 2022 were as follows:

Three Months Ended June 30,

Six Months Ended June 30,

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

Three Months Ended September 30,

Nine Months Ended September 30,

(In thousands)

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Total research and development expenses

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.

The increase in research and development expenses for the three and nine months ended September 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 and increased personnel-related expenses for additional headcount.

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 $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;

General and administrative expenses were $18.4 million and $47.7 million for the three and nine months ended September 30, 2023, respectively, compared to $15.6 million and $29.8 million for the same periods in 2022.

The increase in general and administrative expenses for the three and nine months ended September 30, 2023, compared to the same periods in 2022, primarily reflects higher personnel-related expenses of approximately $5.7 million and $14.2 million, respectively, for additional headcount;

as well as new costs for commercial preparatory activities of approximately $1.9 million and $6.8 million, respectively.

The increases in expense were partially offset by a decrease in legal and accounting expenses of $6.8 million and $6.1 million for the three and nine months ended September 30, 2023, respectively, primarily related to $7.0 million recorded in the third quarter of 2022 for our portion of the settlement in connection with the class action lawsuit.

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 $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 income was $5.0 million and $13.6 million for the three and nine months ended September 30, 2023, respectively, compared to $852,000 and $1.3 million for the same periods in 2022.

The increase in interest income for the three and nine months ended September 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 nine months 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.

Interest Expense

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.

Interest expense was $2.1 million and $6.0 million for the three and nine months ended September 30, 2023, respectively, compared to $1.8 million and $4.9 million for the same periods in 2022.

The increase in interest expense for the three and nine months ended September 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 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 expense was $92,000 for the three months ended September 30, 2023 and net other expense was $64,000 for the nine months ended September 30, 2023, compared to net other expense of $138,000 and net other income of $916,000 for the three and nine months ended September 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 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.

As of September 30, 2023, we had cash, restricted cash, cash equivalents, and marketable securities of $381.9 million, compared to $173.1 million at December 31, 2022.

The increase in cash, restricted cash, cash equivalents and marketable securities during the nine months ended September 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 and receivables from the exercise of outstanding warrants of $105.9 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 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.

From January 1, 2023 through September 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 September 30, 2023, we have received $51.8 million in cash and receivables from the exercise of warrants we issued in 2022, covering 35,714,282 shares of our common stock.

As of September 30, 2023, we had warrants remaining from our 2020 issuance covering 2,474,503 shares of our common stock, which if exercised in full for cash, would provide $3.2 million in cash proceeds.

As of September 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 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.

As of September 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, Inc., or B.

Riley Securities, pursuant to which we were able to elect to issue and sell shares of our common stock having an aggregate offering price of up to $100.0 million in such quantities and on such minimum price terms as we set from time to time through B.

Riley Securities as our sales agent.

Riley Securities was eligible to receive an aggregate commission equal to up to 3.0% of the gross proceeds of the sales under the agreement.

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

Approximately $79.1 million of our common stock remained available for issuance under the 2020 Sales Agreement as of September 4, 2023 when the 2020 Sales Agreement expired.

No further stock will be sold pursuant to the 2020 Sales Agreement.

On November 1, 2023, we entered into a new At Market Issuance Sales Agreement, or the 2023 Sales Agreement, with B.

Riley Securities, pursuant to which we may elect to issue and sell shares of our common stock having an aggregate offering price of up to $100.0 million in such quantities and on such minimum price terms as we set from time to time through B.

Riley Securities as our sales agent.

Riley Securities an aggregate commission rate equal to up to 3.0% of the gross proceeds of the sales price per share for common stock sold through B.

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 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:

(a) the sale of all common stock subject to the 2020 Sales Agreement, or (b) September 4, 2023.

We have agreed to pay B.

Riley Securities an aggregate commission equal to up to 3.0% of the gross proceeds of the sales under the agreement.

Financing Strategy

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Future Funding Requirements

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.

Based on our current operating plan and our expectations regarding the timing of the potential approval of our NDA by the FDA for imetelstat for the treatment of transfusion-dependent anemia in adult patients with lower risk MDS, we believe that our existing cash, cash equivalents, and current and noncurrent marketable securities, together with projected revenues from U.S.

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.

or, if approved, 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.

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 our recently opened expanded access program and non-clinical studies and assessments of imetelstat;

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 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;

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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, as well as any other potential litigation;

expenses associated with potential litigation;

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

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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 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.

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, government shutdowns, 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 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 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, government shutdowns, 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.

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.

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 2023 Sales Agreement, 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.

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 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.

Net cash used in operations for the nine months ended September 30, 2023 and 2022 was $126.8 million and $92.2 million, respectively.

The increase in net cash used in operations for the nine months ended September 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 $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.

Net cash used in investing activities was $227.9 million for the nine months ended September 30, 2023 and net cash provided by investing activities was $43.1 million for the nine months ended September 30, 2022.

The increase in net cash used in investing activities for the nine months ended September 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 six months ended June 30, 2023 and 2022 was $299.4 million and $70.6 million, respectively.

Net cash provided by financing activities for the nine months ended September 30, 2023 and 2022 was $328.7 million and $75.3 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.

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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.

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 six months ended June 30, 2023.

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