What changed in this filing

/stocks — the workspaceLOADING

Item 1. Financial Statements

2022-11-07 compared with 2022-08-11 · 212 added, 128 removed, 784 unchanged (30% of the section changed)

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(IN THOUSANDS)

SEPTEMBER 30,

Current assets:

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THREE MONTHS ENDED

SIX MONTHS ENDED

NINE MONTHS ENDED

SEPTEMBER 30,

License fees and royalties

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THREE MONTHS ENDED

SIX MONTHS ENDED

Net unrealized loss on marketable securities

NINE MONTHS ENDED

SEPTEMBER 30,

Net unrealized gain (loss) on marketable securities

Foreign currency translation adjustments

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Stock-based compensation

related to issuance of

common stock and

options in exchange

related to issuance of common

stock and options in exchange

Stock-based compensation for

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Stock-based compensation

related to issuance of

common stock and

options in exchange

related to issuance of common

stock and options in exchange

Issuances of common stock

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Balances at June 30, 2022

Other comprehensive income

Comprehensive loss

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

Balances at September 30, 2022

GERON CORPORATION

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Stock-based compensation

related to issuance of

common stock and

options in exchange

related to issuance of common

stock and options in exchange

Issuance of common stock in

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Stock-based compensation

related to issuance of

common stock and

options in exchange

related to issuance of common

stock and options in exchange

Issuance of common stock in

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Balances at June 30, 2021

Other comprehensive income

Stock-based compensation

related to issuance of common

stock and options in exchange

Stock-based compensation for

equity-based awards to

employees and directors

Balances at September 30, 2021

See accompanying notes.

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(IN THOUSANDS)

SIX MONTHS ENDED

NINE MONTHS ENDED

SEPTEMBER 30,

Cash flows from operating activities:

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NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

June 30, 2022

September 30, 2022

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

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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, 2022 are not necessarily indicative of the results that may be expected for the year ending December 31, 2022 or any other period.

Operating results for the three and nine months ended September 30, 2022 are not necessarily indicative of the results that may be expected for the year ending December 31, 2022 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, 2021, included in our Annual Report on Form 10-K for the year ended December 31, 2021, or the Form 10-K.

The accompanying condensed balance sheet as of December 31, 2021 has been derived from audited financial statements at that date.

Since inception, we have incurred net losses and generated negative cash flows from operations.

During the three and nine months ended September 30, 2022, we incurred net losses of $ 41,051,000 and $ 99,266 000 , respectively, and in the nine months ended September 30, 2022, we generated negative cash flows from operations of $ 92,198,000 .

As of September 30, 2022, we had an accumulated deficit of $ 1,371,007,000 .

We expect our accumulated deficit will increase significantly over time and do not expect to experience positive cash flows from operations in the near future.

As of September 30, 2022, we had $ 195,151,000 of cash, restricted cash, cash equivalents, and marketable securities.

On April 1, 2022, we completed an underwritten public offering of 53,333,334 shares of our common stock and a pre-funded warrant to purchase 18,095,238 shares of our common stock, also known as the 2022 pre-funded warrant, together with accompanying warrants to purchase 35,714,286 shares of our common stock, also known as the 2022 stock purchase warrants.

The net cash proceeds from this offering were $ 69,916,000 , after deducting the underwriting discount and other offering expenses paid by us and exclude any future proceeds from the exercise of the 2022 pre-funded warrant and 2022 stock purchase warrants.

See Note 6 on Stockholders' Equity for further discussion of the April 2022 public offering.

We believe our existing cash, cash equivalents and short-term marketable securities will be sufficient to fund our operations for a period of at least one year from the date of filing of this Quarterly Report on Form 10-Q.

In any event, we will require substantial additional funding to further advance the imetelstat program, including through the completion of IMpactMF and IMproveMF and the planned investigator-led trials in AML and higher risk MDS, as well as conducting the clinical, regulatory and potential commercialization activities necessary to potentially bring imetelstat to market in lower risk MDS and refractory MF, and our need for additional funds may arise sooner than planned.

If adequate funds are not available on a timely basis, if at all, we may be unable to pursue further development, including completing IMpactMF and IMproveMF, or commencing, conducting or completing potential future clinical trials of imetelstat, such as the planned investigator-led clinical trials in AML and higher risk MDS, or pursuing potential commercialization of imetelstat, which would severely harm our business and we might cease operations.

Principles of Consolidation

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

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

stock, also known as the 2020 pre-funded warrant, together with accompanying warrants to purchase shares of our common stock.

The 2022 pre-funded warrant and 2020 pre-funded warrant are exercisable immediately at an exercise price of $ 0.001 per share.

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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, 2022 and 2021 , the diluted net loss per share calculation excludes potential dilutive securities of 153,703,476 and 106,492,740 , 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, 2022 and 2021 , the diluted net loss per share calculation excludes potential dilutive securities of 174,347,456 and 105,466,722 , respectively, related to outstanding stock options and warrants as their effect would have been anti-dilutive.

Use of Estimates

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Declines in market value judged as other than temporary result in a charge to interest income.

We have not recorded any other-than-temporary impairment charges on our available-for-sale securities for the three and six months ended June 30, 2022 and 2021 .

We have not recorded any other-than-temporary impairment charges on our available-for-sale securities for the three and nine months ended September 30, 2022 and 2021 .

See Note 2 on Fair Value Measurements.

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

As of June 30, 2021, no active license agreements remain.

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

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

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For example, milestone payments that are not within our control, such as regulatory-related accomplishments, are not considered probable of being achieved until those accomplishments have been communicated by the relevant regulatory authority.

Once the assessment of probability of achievement becomes probable, we recognize revenue for the milestone payment.

Once the assessment of

probability of achievement becomes probable, we recognize revenue for the milestone payment.

At each reporting date, we assess the probability of achievement of each milestone under any current agreements.

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We base our estimates on the best information available at the time.

additional information may become available to us which will allow us to make a more accurate estimate in future periods.

However, additional information may become available to us which will allow us to make a more accurate estimate in future periods.

In that event, we may be required to record adjustments to research and development expenses in future periods when the actual level of activity becomes more certain.

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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, 2022 and 2021, 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, 2022 and 2021, which was allocated as follows:

Three Months Ended September 30,

Nine Months Ended September 30,

(In thousands)

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Stock-based compensation expense included in operating expenses

As stock-based compensation expense recognized in our condensed consolidated statements of operations for the three and six months ended June 30, 2022 and 2021 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, 2022 and 2021 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, 2022 and 2021, as achievement of the specified strategic milestones was not considered probable at that time.

We have not recognized any stock-based compensation expense for performance-based stock options on our condensed consolidated statements of operations for the three and nine months ended September 30, 2022 and 2021, as achievement of the specified strategic milestones was not considered probable at that time.

Stock Options

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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, 2022 and 2021 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, 2022 and 2021 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

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The fair value of employees’

stock purchase rights during the six months ended June 30, 2022 and 2021 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, 2022 and 2021 has been estimated using the Black Scholes option-pricing model with the following assumptions:

Nine Months Ended September 30,

Dividend yield

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ASU 2020-06 is effective for fiscal years beginning after December 15, 2021, and interim periods within those fiscal years for public business entities that are not smaller reporting companies.

For all other entities, ASU 2020-06 is effective for fiscal years beginning after December 15, 2023, and interim periods within those

fiscal years.

For all other entities, ASU 2020-06 is effective for fiscal years beginning after December 15, 2023, and interim periods within those fiscal years.

We plan to adopt ASU 2020-06 as of January 1, 2024.

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Cash Equivalents and Marketable Securities

Cash equivalents, restricted cash and marketable securities by security type at June 30, 2022 were as follows:

Cash equivalents, restricted cash and marketable securities by security type at September 30, 2022 were as follows:

(In thousands)

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Corporate notes (due in one to two years)

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, 2022 and December 31, 2021 were as follows:

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, 2022 and December 31, 2021 were as follows:

Less Than 12 Months

1 unchanged sentence

(In thousands)

As of June 30, 2022:

As of September 30, 2022:

Treasury securities (due in

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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, 2022 and December 31, 2021 were due to changes in interest rates and not credit risk.

We determined that the gross unrealized losses on our cash equivalents and marketable securities as of June 30, 2022 and December 31, 2021 were temporary in nature.

Treasury securities, municipal securities, government-sponsored enterprise securities, commercial paper and corporate notes as of September 30, 2022 and December 31, 2021 were due to changes in interest rates and not credit risk.

We determined that the gross unrealized losses on our cash equivalents and marketable securities as of September 30, 2022 and December 31, 2021 were temporary in nature.

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

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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, 2022 and December 31, 2021 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, 2022 and December 31, 2021 and indicates the fair value category assigned.

Fair Value Measurements at Reporting Date Using

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(In thousands)

As of June 30, 2022:

As of September 30, 2022:

Money market funds (1)

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ACCRUED LIABILITIES

Accrued liabilities consisted of the following as of June 30, 2022 and December 31, 2021:

Accrued liabilities consisted of the following as of September 30, 2022 and December 31, 2021:

September 30,

(In thousands)

CRO and clinical trial costs

Securities class action settlement

Manufacturing activities

1 unchanged sentence

Interest payable

See Note 5 on Contingencies and Uncertainties - Purported Securities Lawsuits for further information on the securities class action settlement.

On September 30, 2020, we, Hercules Capital, Inc., or Hercules, and Silicon Valley Bank, or SVB, entered into a term loan facility, or the Original Loan Agreement, up to $ 75,000,000 , as amended in August 2021.

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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, 2022 , a total of $ 50,000,000 has been drawn under the Loan Agreement.

Under the second amendment, the $ 75,000,000 in remaining loan principal as of June 30, 2022 can be drawn as follows:

As of September 30, 2022 , a total of $ 50,000,000 had been drawn under the Loan Agreement.

Under the second amendment, the $ 75,000,000 in remaining loan principal as of September 30, 2022 can be drawn as follows:

(a) the first tranche of $ 20,000,000 is available within 30 days of the achievement of certain clinical and financial milestones until September 15, 2023 , subject to the achievement of such milestones;

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With the exception of the final tranche, and subject to achievement of the applicable milestones and other requirements with respect to each tranche, draw downs are at our election.

On the Effective Date of the second amendment, we paid $ 100,000 as a facility charge that we recognized as a debt discount and will be amortizing such cost to interest expense over the life of the loan using the effective interest rate method.

On the Effective Date of the second amendment, we paid $ 100,000 as a facility charge that we recognized as a debt discount and are amortizing such cost to interest expense over the life of the loan using the effective interest rate method.

Additional facility charges applied to future draw downs will be treated similarly.

As of June 30, 2022, we also incurred approximately $ 14,000 in legal fees in connection with the second amendment, which we recognized as debt issuance costs and will be amortizing such cost to interest expense over the life of the loan using the effective interest rate method.

We incurred approximately $ 75,000 in legal fees in connection with the second amendment, which we recognized as debt issuance costs and are amortizing such cost to interest expense over the life of the loan using the effective interest rate method.

Future debt issuance costs will be treated similarly.

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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, 2022.

As of June 30, 2022 , the net carrying value of the debt under the Loan Agreement was $ 50,420,000 , which includes the principal amount of $ 50,000,000 less net unamortized debt discounts and issuance costs of $ 801,000 plus accrued end of term charge of $ 1,221,000 .

The carrying value of the debt approximates the fair value as of June 30, 2022.

We are in compliance with the covenants under the Loan Agreement as of September 30, 2022.

As of September 30, 2022 , the net carrying value of the debt under the Loan Agreement was $ 50,758,000 , which includes the principal amount of $ 50,000,000 less net unamortized debt discounts and issuance costs of $ 747,000 plus accrued end of term charge

of $ 1,505,000 .

The carrying value of the debt approximates the fair value as of September 30, 2022.

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, 2022 (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, 2022 (in thousands):

Remainder of 2022

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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, our Phase 2 clinical trial designed to evaluate two dosing regimens of imetelstat (either 4.7 mg/kg or 9.4 mg/kg administered by intravenous infusion every three weeks) in relapsed/refractory myelofibrosis, 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.

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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.

Our answer to the amended and 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.

Discovery has commenced and will be completed by October 14, 2022.

Trial is scheduled to begin on January 17, 2023.

On September 2, 2022, the parties agreed to a settlement, which is subject to Court approval.

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

settlement, permitted notice to be distributed to the class members, and scheduled a final approval hearing for March 30, 2023.

In connection with the settlement, the parties entered into a Stipulation and Agreement of Settlement, or the Stipulation, on September 2, 2022 to resolve the consolidated class action complaint.

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 is expected to be paid under the available D&O insurance coverage and, at our election, $ 7,000,000 in either shares of Geron common stock and/or cash.

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 September 30, 2022, on our condensed consolidated balance sheet, we have recorded the total settlement amount of $ 24,000,000 as accrued liabilities and $ 17,000,000 as interest and other receivables.

For the three and nine months ended September 30, 2022, we have recognized $ 7,000,000 as general and administrative expense on our condensed consolidated statements of operations.

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

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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 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:

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

The Court of Chancery of the State of Delaware 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 the trial in the consolidated class action lawsuit described above;

The Court of Chancery of the State of Delaware 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;

The consolidated shareholder derivative actions filed in the U.S.

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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 class action lawsuit described above or a final, non-appealable judgment in the consolidated class action lawsuit described above.

The stay was continued on September 16, 2022, for an additional 60 days;

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

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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.

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

We currently are not able to estimate the possible cost to us from these matters, as the pending lawsuits are currently at an early stage, and we cannot be certain how long it may take to resolve the pending lawsuits or the possible amount of any damages that we may be required to pay.

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

As discussed above, we have recorded the total settlement amount for the Stipulation on our condensed consolidated balance sheet as of September 30, 2022.

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

Such amounts could be material to our 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.

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

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

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

If the effects of the COVID-19 pandemic continue and/or become more severe, we could experience significant disruptions to our clinical development timelines, delays in clinical site initiation and patient enrollment in IMpactMF, IMproveMF and the planned investigator-led clinical trials in acute myeloid leukemia, or AML, and Intermediate-2 or High-risk myelodysplastic syndromes, or higher risk MDS, and other disruptions that could severely impact our business and the imetelstat development program.

trials in acute myeloid leukemia, or AML, and Intermediate-2 or High-risk myelodysplastic syndromes, or higher risk MDS, and other disruptions that could severely impact our business and the imetelstat development program.

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

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

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

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

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In addition, the global economic slowdown caused by, among other things, the COVID-19 pandemic and the military conflict between Ukraine and Russia, as well as inflation, rising interest rates and the prospects for recession, could materially and adversely affect our business and the value of our common stock.

and business closure requirements in the U.S.

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

The extent to which the COVID-19 pandemic and the military conflict between Ukraine and Russia ultimately impact our business, our regulatory and clinical development activities, clinical supply chain and other business operations, as well as the value of and market for our common stock, will depend on future developments that are highly uncertain and cannot be predicted with confidence at this time, such as the ultimate duration and severity of the pandemic, travel restrictions, quarantines, social distancing and business closure requirements in the United States, or U.S., and in other countries, the effectiveness of actions taken globally to contain and treat COVID-19 and whether the military conflict between Ukraine and Russia resolves in a timely manner, or at all.

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

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The 2022 pre-funded warrant has an exercise price of $ 0.001 per share and may be exercised at any time until the 2022 pre-funded warrant is exercised in full.

As of June 30, 2022 , none of the 2022 pre-funded warrant and 2022 stock purchase warrants have been exercised.

As of September 30, 2022 , none of the 2022 pre-funded warrant and 2022 stock purchase warrants have been exercised.

The net cash proceeds from this offering were $ 69,916,000 , after deducting the underwriting discount and other offering expenses paid by us, and exclude any future proceeds from the exercise of the 2022 pre-funded warrant and 2022 stock purchase warrants.

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Based on our evaluation, we concluded the 2022 pre-funded warrant and the 2022 stock purchase warrants should be classified as equity with no subsequent remeasurement as long as such warrants continue to be classified as equity.

Employee Stock Purchase Plan

In May 2022, our stockholders approved an amendment to our 2014 Employee Stock Purchase Plan to increase the total number of shares issuable under such plan by 1,000,000 shares of common stock.

2018 Equity Incentive Plan

In May 2022, our stockholders approved an amendment to our 2018 Equity Incentive Plan to increase the total number of shares issuable under such plan by 11,000,000 shares of common stock.

Warrant Exercises

In the third quarter of 2022, warrants to purchase 2,798,003 shares of Geron common stock were exercised for net cash proceeds of approximately $ 3,638,000 .

The warrants were issued in connection with an underwritten public offering of common stock and a pre-funded warrant, together with accompanying stock purchase warrants in May 2020.

As of September 30, 2022, the pre-funded warrant to purchase 8,335,239 shares of our common stock was outstanding and stock purchase warrants to purchase 52,975,463 shares of our common stock associated with the May 2020 public offering remained outstanding.

2018 Inducement Award Plan

In December 2018, our board of directors approved the adoption of the 2018 Inducement Award Plan, or the Inducement Plan, to be used exclusively for grants of inducement awards to individuals who were not previously our employees or non-employee directors, other than following a bona fide period of non-employment.

As of June 30, 2022, a total of 16,100,000 shares of our common stock had been reserved (subject to customary adjustments in the event of a change in capital structure) under the Inducement Plan.

In July 2022, our Compensation Committee approved an amendment to increase the reserve under the Inducement Plan by 5,000,000 shares.

As of September 30, 2022, a total of 21,100,000 shares of our common stock had been reserved (subject to customary adjustments in the event of a change in capital structure) under the Inducement Plan.

The Inducement Plan provides for the grant of nonstatutory stock options, stock appreciation rights, restricted stock awards, restricted stock units and other stock awards, and all awards under the Inducement Plan are intended to meet the standards under Rule 5635(c)(4) of the Nasdaq Listing Rules.

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Geron’s vision is to become a leader in the treatment of blood cancers, or hematologic malignancies, and is committed to improving and extending the lives of patients by changing the course of these diseases by targeting telomerase.

We believe data from our prior Phase 2 clinical trials 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 indicate potential disease-modifying activity.

We believe data from our prior Phase 2 clinical trials provide strong evidence that imetelstat targets telomerase to inhibit the uncontrolled proliferation of malignant stem and progenitor cells enabling recovery of bone marrow and blood cell production, which indicate potential disease-modifying activity.

We believe this potential disease modification may differentiate imetelstat from other currently approved and investigational treatments in myeloid hematologic malignancies.

1 unchanged sentence

(i) IMerge Phase 3 in Low or Intermediate-1 risk myelodysplastic syndromes, or lower risk MDS, and

(ii) IMpactMF in Intermediate-2 or High-risk myelofibrosis, or refractory MF.

(ii) IMpactMF in Intermediate-2 or High-risk myelofibrosis, or relapsed/refractory MF.

For IMerge Phase 3, we expect top-line results to be available in early January 2023, based on current planning assumptions.

In July 2022, the regularly scheduled Independent Data Monitoring Committee for IMerge Phase 3 met, and the committee recommended the trial continue without modification.

Assuming the results of IMerge Phase 3 support regulatory submissions, we plan to submit a New Drug Application, or NDA, in the U.S.

In September 2022, the Hepatic Expert Committee for IMerge Phase 3 convened at a regularly scheduled meeting, and recommended the trial continue without modification.

Assuming the top-line results of IMerge Phase 3 support regulatory submissions, we plan to submit a New Drug Application, or NDA, in the U.S.

in the first half of 2023, and a marketing authorization application, or MAA, in Europe in the second half of 2023, for imetelstat in lower risk MDS.

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For IMpactMF, clinical site openings and patient screening and enrollment continue.

In October 2022, the first meeting of the Independent Data Monitoring Committee for IMpactMF was held, and the committee recommended the trial continue without modification.

Under current planning assumptions, we expect the trial to be fully enrolled in 2024.

In addition, we expect the interim analysis for overall survival, or OS, for IMpactMF may occur in 2024 and the final analysis in 2025.

Because these analyses are event-driven, the results may be available at different times than currently expected.

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

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

In addition to the ongoing Phase 3 clinical trials, we have several exploratory clinical programs designed to investigate the potential use of imetelstat in additional indications.

In May 2022, the first clinical site opened for enrollment in IMproveMF, a Phase 1 clinical trial of imetelstat in combination with ruxolitinib in frontline Intermediate-2 or High-risk myelofibrosis, or frontline MF, patients.

In addition, in collaboration with key opinion leaders with expertise in acute myeloid leukemia, or AML, we plan to support one or more investigator-led clinical trials in AML and Intermediate-2 or High-risk myelodysplastic syndromes, or higher risk MDS, to evaluate imetelstat as a single agent and in combination with venetoclax or hypomethylating agents, or HMAs, in the second half of 2022.

Imetelstat has been granted Fast Track designations by the FDA for the treatment of patients with transfusion-dependent anemia due to lower risk MDS, who do not have a deletion 5q chromosomal abnormality, also known as non-del(5q), and who are refractory or resistant to treatment with an erythropoiesis stimulating agent, or ESA, and for the treatment of patients with myelofibrosis, or MF,

who have relapsed after or are refractory to treatment with a janus associated kinase, or JAK, inhibitor, also known as relapsed/refractory MF.

We expect to present preliminary data from this trial by the end of 2023.

In collaboration with key opinion leaders with expertise in acute myeloid leukemia, or AML, we plan to support a Phase 2 investigator-led trial named IMpress to evaluate imetelstat as a single agent in AML and Intermediate-2 or High-risk myelodysplastic syndromes, or higher risk MDS.

We expect this study to start in the fourth quarter of 2022.

We also expect to support another investigator-led trial named TELOMERE, which is a Phase 1/2

study to evaluate imetelstat in combination with venetoclax or azacitidine in relapsed/refractory AML.

The planned start date for TELOMERE is pending IMpress single-agent imetelstat data.

We expect such data to help inform the dose and schedule to be used in the two combination dosing regimens to be evaluated in TELOMERE.

We also have a non-clinical research program in lymphoid malignancies that is being conducted in collaboration with MD Anderson Cancer Center.

Additionally, we have an ongoing discovery research program to identify next generation small molecule telomerase inhibitors, with a goal to identify a lead compound(s) in 2023.

Imetelstat has also been granted orphan drug designations by the FDA in the U.S.

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In October 2021, we gained access to the Innovative Licensing and Access Pathway, or ILAP, in the United Kingdom, or U.K., through the receipt of an Innovation Passport for imetelstat to treat lower risk MDS.

Recent Data from the IMerge Phase 2 Clinical Trial

In November 2022, we reported longer treatment and follow-up data of patients in IMerge Phase 2, including the characteristics and clinical benefits for those patients who experienced continued transfusion independence, or TI, for greater than one year while treated with imetelstat.

Baseline characteristic

Patients with TI >1 year (n=11)

IPSS category, n (%)

Intermediate-1 risk

MDS-RS, n (%)

Prior RBC transfusion burden over 8 weeks prior to study treatment, median (range)

6.0 units (4-14)

Prior ESA, n (%)

≥2 years since initial diagnosis, n (%)

Normal karyotype, n (%)

Of the 38 lower risk MDS patients in IMerge Phase 2 who were non-del(5q) and naïve to treatment with lenalidomide or hypomethylating agents, 29% (11/38) of patients achieved >1-year sustained TI, representing 69% (11/16) of the responders who achieved 8-week TI and 92% (11/12) of the responders who achieved ≥

These 11 patients were treated with imetelstat for a median duration of 126.1 weeks (range:

70.1-168.1) for a median of 27 cycles (range:

The median duration of TI for these 11 patients was 92.4 weeks (95% confidence interval:

After a median follow-up of 51.5 months, median progression-free survival was 34.2 months (95% confidence interval:

25.1, 39.2), median overall survival was 57.0 months (95% confidence interval:

29.4, not evaluable), and none of the 11 patients progressed to AML.

Furthermore, 27 of the 38 patients were ring sideroblast positive, or RS+, and of these, 37% (10/27) achieved TI for > 1 year.

Of the 11 patients who achieved >1-year sustained TI, nine had mutation data available;

and 89% (8/11) had a reduction in SF3B1 variant allele frequency, or VAF, and 56% (5/11) achieved ≥50% VAF reduction.

Reduction in VAF correlated with longer TI duration (median TI >20 months) and shorter time to onset of TI (<10 weeks).

Safety findings were consistent with the overall population, and the most frequent adverse events were reversible thrombocytopenia and neutropenia.

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, 2022, we had approximately $219.7 million in cash, cash equivalents, restricted cash and marketable securities and a long-term principal debt balance of $50.0 million.

As of September 30, 2022, we had approximately $195.2 million in cash, cash equivalents, restricted cash and marketable securities and a long-term principal debt balance of $50.0 million.

In April 2022, we completed an underwritten public offering of 53,333,334 shares of our common stock and a pre-funded warrant to purchase 18,095,238 shares of our common stock, also known as the 2022 pre-funded warrant, together with accompanying warrants to purchase 35,714,286 shares of our common stock, also known as the 2022 stock purchase warrants.

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The net cash proceeds from this offering were $69.9 million, after deducting the underwriting discount and other offering expenses paid by us, and exclude any potential future proceeds from the exercise of the 2022 pre-funded warrant and 2022 stock purchase warrants.

See Note 6 on Stockholders' Equity in Notes to Condensed Consolidated Financial Statements of this quarterly report on Form 10-Q for additional information about the underwritten public offering completed in April 2022.

on Stockholders' Equity in Notes to Condensed Consolidated Financial Statements of this quarterly report on Form 10-Q for additional information about the underwritten public offering completed in April 2022.

In the third quarter of 2022, warrants to purchase 2,798,003 shares of Geron common stock were exercised for net cash proceeds of approximately $3.6 million.

The warrants were issued in connection with an underwritten public offering of common stock and a pre-funded warrant, together with accompanying stock purchase warrants in May 2020.

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, 2022, $75.0 million is available to be drawn in a series of tranches under the Loan Agreement, subject to certain terms and conditions.

As of September 30, 2022, $75.0 million is available to be drawn in a series of tranches under the Loan Agreement, subject to certain terms and conditions.

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

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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, 2022, we had an accumulated deficit of approximately $1.3 billion.

As of September 30, 2022, we had an accumulated deficit of approximately $1.4 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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commercial launch of imetelstat in lower risk MDS, until the middle of 2024.

Absent these potential future warrant proceeds and availability of debt drawdowns, under current planning assumptions, we believe our existing capital resources will be sufficient to fund our projected level of operations, which includes stage-gated activities for potential U.S.

commercial launch of imetelstat in lower risk MDS, until the end of the third quarter of 2023.

commercial launch of imetelstat in lower risk MDS contingent upon positive top-line results from the IMerge Phase 3 trial, until the end of 2023.

We will require substantial additional funding to further advance the imetelstat program, including through the completion of IMpactMF and IMproveMF and the planned investigator-led trials in AML and higher risk MDS, as well as conducting the clinical, regulatory and potential commercialization activities necessary to potentially bring imetelstat to market in lower risk MDS and refractory MF.

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

in Part II, Item 1A and Note 5 on

Contingencies and Uncertainties –

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

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

CRITICAL ACCOUNTING POLICIES AND ESTIMATES

There have been no significant changes in our critical accounting policies and estimates during the six months ended June 30, 2022, as compared to the critical accounting policies and estimates disclosed in our 2021 Form 10-K.

There have been no significant changes in our critical accounting policies and estimates during the nine months ended September 30, 2022, as compared to the critical accounting policies and estimates disclosed in our 2021 Form 10-K.

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

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

We recognized license fee revenues of $28,000 for each of the three and six months ended June 30, 2021 related to a previous license agreement for our non-imetelstat related technologies.

No comparable amounts were recognized for the three and six months ended June 30, 2022.

We recognized royalty revenues of $73,000 and $196,000 for the three and six months ended June 30, 2022, respectively, compared to $79,000 and $216,000 for the same periods in 2021.

We recognized zero license fee revenues for the three months ended September 30, 2021, and $28,000 for the nine months ended September 30, 2021, related to a previous license agreement for our non-imetelstat related technologies.

No license fee revenues were recognized for the three and nine months ended September 30, 2022.

We recognized royalty revenues of $297,000 and $493,000 for the three and nine months ended September 30, 2022, respectively, compared to $109,000 and $325,000 for the same periods in 2021.

Royalty revenues in 2022 and 2021 primarily reflect estimated royalties from sales of cell-based research products from our divested stem cell assets.

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Historical revenues may not be predictive of future revenues.

Absent any retroactive royalty payments, such as the one-time payment received from Lineage in

the fourth quarter of 2021, we expect revenues in 2022 to be lower than 2021 as a result of reduced royalties from sales of cell-based research products from our divested stem cell assets.

Absent any retroactive royalty payments, such as the one-time payment received from Lineage in the fourth quarter of 2021, we expect royalty revenues in 2022 to be comparable to 2021 from sales of cell-based research products from our divested stem cell assets.

Research and Development Expenses

During the three and six months ended June 30, 2022 and 2021, 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, 2022 and 2021, 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, 2022 and 2021, 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, 2022 and 2021, 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, 2022 and 2021 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, 2022 and 2021 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 decrease in research and development expenses for the three and six months ended June 30, 2022, compared to the same periods in 2021, primarily reflects the net result of decreased manufacturing costs due to the timing of imetelstat manufacturing batches;

partially offset by increased personnel-related expenses for additional headcount and higher consulting costs related to preparation for top-line results and regulatory submissions in lower risk MDS.

The increase in research and development expenses for the three and nine months ended September 30, 2022, compared to the same periods in 2021, primarily reflects the net result of increased personnel-related expenses for additional headcount and higher consulting costs related to preparation for top-line results and regulatory submissions in lower risk MDS;

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

We expect research and development expenses to increase in the future as we support the current two Phase 3 clinical trials of imetelstat, IMerge and IMpactMF, the IMproveMF trial and planned investigator-led trials in AML and higher risk MDS.

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General and Administrative Expenses

General and administrative expenses were $7.4 million and $14.1 million for the three and six months ended June 30, 2022, respectively, compared to $7.1 million and $14.5 million for the same periods in 2021.

The increase in general and administrative expenses for the three months ended June 30, 2022, compared to the same period in 2021, primarily reflects the net result of increased costs for commercial preparatory activities of approximately $563,000 and higher personnel-related expenses of approximately $573,000 for additional headcount;

partially offset by lower legal fees of approximately $364,000 and reduced consulting costs of approximately $530,000 related to modernizing the internal infrastructure to support potential commercial launch.

The decrease in general and administrative expenses for the six months ended June 30, 2022, compared to the same period in 2021, primarily reflects the net result of reduced consulting costs of approximately $1.2 million related to modernizing the internal infrastructure to support potential commercial launch and lower legal fees of approximately $586,000;

partially offset by higher personnel-related expenses of approximately $797,000 for additional headcount and higher costs for commercial preparatory activities of approximately $349,000.

General and administrative expenses were $15.6 million and $29.8 million for the three and nine months ended September 30, 2022, respectively, compared to $7.3 million and $21.8 million for the same periods in 2021.

The increase in general and administrative expenses for the three and nine months ended September 30, 2022, compared to the same periods in 2021, primarily reflects increased costs for commercial preparatory activities of approximately $826,000 and $725,000 respectively;

higher personnel-related expenses of approximately $1.2 million and $2.2 million, respectively for additional headcount;

and approximately $7.0 million recorded in the third quarter of 2022 for our portion of the potential settlement in connection with the class action lawsuit.

See Note 5 on Contingencies and Uncertainties in Notes to Condensed Consolidated Financial Statements of this quarterly report on Form 10-Q for additional information about the settlement.

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 $330,000 and $442,000 for the three and six months ended June 30, 2022, respectively, compared to $136,000 and $309,000 for the same periods in 2021.

The increase in interest income for the three and six months ended June 30, 2022, compared to the same periods in 2021, primarily reflects a larger marketable securities portfolio with the receipt of net cash proceeds from the underwritten public offering completed in April 2022 and higher yields from recent marketable securities purchases.

Interest income was $852,000 and $1.3 million for the three and nine months ended September 30, 2022, respectively, compared to $112,000 and $421,000 for the same periods in 2021.

The increase in interest income for the three and nine months ended September 30, 2022, compared to the same periods in 2021, primarily reflects a larger marketable securities portfolio with the receipt of net cash proceeds from the underwritten public offering completed in April 2022 and 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.

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Interest Expense

Interest expense was $1.6 million and $3.1 million for the three and six months ended June 30, 2022, respectively, compared to $804,000 and $1.5 million for the same periods in 2021.

The increase in interest expense for the three and six months ended June 30, 2022, compared to the same periods in 2021, primarily reflects rising interest rates and an increased principal debt balance under the Loan Agreement.

Interest expense was $1.8 million and $4.9 million for the three and nine months ended September 30, 2022, respectively, compared to $1.1 million and $2.6 million for the same periods in 2021.

The increase in interest expense for the three and nine months ended September 30, 2022, compared to the same periods in 2021, primarily reflects rising interest rates and an increased principal debt balance under the Loan Agreement.

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

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Other Income and (Expense), Net

Net other income was $1.1 million and $1.1 million for the three and six months ended June 30, 2022, respectively, compared to net other expense of $17,000 and net other income of $1.2 million for the same periods in 2021.

Net other expense was $138,000 and $77,000 for the three months ended September 30, 2022 and 2021, respectively.

Net other income was $916,000 and $1.1 million for the nine months ended September 30, 2022 and 2021, respectively.

In the second quarter of 2022, we recognized other income of approximately $1.3 million related to the reimbursement of certain legal expenses under our insurance policies.

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LIQUIDITY AND CAPITAL RESOURCES

As of June 30, 2022, we had cash, restricted cash, cash equivalents, and marketable securities of $219.7 million, compared to $212.7 million at December 31, 2021.

The increase in cash, restricted cash, cash equivalents and marketable securities during the six months ended June 30, 2022 was primarily the net result of the receipt of net cash proceeds of $69.9 million from our underwritten public offering completed in April 2022, partially offset by cash being used for operations.

As of September 30, 2022, we had cash, restricted cash, cash equivalents, and marketable securities of $195.2 million, compared to $212.7 million at December 31, 2021.

The increase in cash, restricted cash, cash equivalents and marketable securities during the nine months ended September 30, 2022 was primarily the net result of the receipt of net cash proceeds of $69.9 million from our underwritten public offering completed in April 2022, partially offset by cash being used for operations.

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As of June 30, 2022 and December 31, 2021 we had a long-term principal debt balance of $50.0 million under the Loan Agreement with Hercules and SVB.

In the third quarter of 2022, warrants to purchase 2,798,003 shares of Geron common stock were exercised for net cash proceeds of approximately $3.6 million.

The warrants were issued in connection with an underwritten public offering of common stock and a pre-funded warrant, together with accompanying stock purchase warrants in May 2020.

As of September 30, 2022 and December 31, 2021 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, 2022, a total of $75.0 million is available to be drawn in a series of tranches under the Loan Agreement, subject to certain terms and conditions.

As of September 30, 2022, a total of $75.0 million is available to be drawn in a series of tranches under the Loan Agreement, subject to certain terms and conditions.

Of this amount, $50.0 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.

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For the year ended December 31, 2021, we sold an aggregate of 10,571,556 shares of our common stock pursuant to the 2020 Sales Agreement, resulting in net cash proceeds to us of approximately $20.4 million, after deducting sales commissions and other offering expenses payable by us.

We did not sell any shares of our common stock pursuant to the 2020 Sales Agreement during the six months ended June 30, 2022.

Approximately $79.1 million of our common stock remained available for issuance under the 2020 Sales Agreement as of June 30, 2022.

We did not sell any shares of our common stock pursuant to the 2020 Sales Agreement during the nine months ended September 30, 2022.

Approximately $79.1 million of our common stock remained available for issuance under the 2020 Sales Agreement as of September 30, 2022.

The 2020 Sales Agreement will expire upon the earlier of:

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Absent these potential warrant proceeds and availability of debt drawdowns under the Loan Agreement, under current planning assumptions, we believe our existing capital resources will be sufficient to fund our projected level of operations, which includes stage-gated activities for potential U.S.

commercial launch of imetelstat in lower risk MDS, until the end of the third quarter of 2023.

Importantly, our ability to raise additional capital to fund our operations after the end of the third quarter of 2023 will be substantially dependent on the top-line results from IMerge Phase 3.

If the top-line results from IMerge Phase 3 are negative, inconclusive or otherwise do not meet the expectations of investors, analysts and our lenders, our ability to raise additional capital to fund our operations after the end of the third quarter of 2023 will be substantially impaired, which might cause us to cease operations.

commercial launch of imetelstat in lower risk MDS contingent upon positive top-line results from the IMerge Phase 3 trial, until the end of 2023.

Importantly, our ability to raise additional capital to fund our operations after the end of 2023 will be substantially dependent on the top-line results from IMerge Phase 3.

If the top-line results from IMerge Phase 3 are negative, inconclusive or otherwise do not meet the expectations of investors, analysts and our lenders, our ability to raise additional capital to fund our operations after the end of 2023 will be substantially impaired, which might cause us to cease operations.

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Cash Flows from Operating Activities

Net cash used in operations for the six months ended June 30, 2022 and 2021 was $62.6 million and $50.5 million, respectively.

The increase in net cash used in operations for the six months ended June 30, 2022, compared to the same period in 2021, primarily reflects higher payments for research and development expenses in connection with supporting the current Phase 3 clinical trials, IMerge and IMpactMF, and increases in headcount.

Net cash used in operations for the nine months ended September 30, 2022 and 2021 was $92.2 million and $73.4 million, respectively.

The increase in net cash used in operations for the nine months ended September 30, 2022, compared to the same period in 2021, primarily reflects higher payments for research and development expenses in connection with supporting the current Phase 3 clinical trials, IMerge and IMpactMF, and increases in headcount.

Cash Flows from Investing Activities

Net cash provided by investing activities for the six months ended June 30, 2022 and 2021 was $33.2 million and $69.0 million, respectively.

The decrease in net cash provided by investing activities for the six months ended June 30, 2022, compared to the same period in 2021, primarily reflects a higher rate of purchases than maturities of marketable securities in 2022 from the investment of net cash proceeds received from the underwritten public offering completed in April 2022.

Net cash provided by investing activities for the nine months ended September 30, 2022 and 2021 was $43.1 million and $63.6 million, respectively.

The decrease in net cash provided by investing activities for the nine months ended September 30, 2022, compared to the same period in 2021, primarily reflects a higher rate of purchases than maturities of marketable securities in 2022 from the investment of net cash proceeds received from the underwritten public offering completed in April 2022.

Cash Flows from Financing Activities

Net cash provided by financing activities for the six months ended June 30, 2022 and 2021 was $70.6 million and $28.9 million, respectively.

Financing activities in 2022 primarily reflect the receipt of net cash proceeds from the underwritten public offering completed in April 2022.

Net cash provided by financing activities for the nine months ended September 30, 2022 and 2021 was $75.3 million and $28.9 million, respectively.

Financing activities in 2022 primarily reflect the receipt of net cash proceeds from the underwritten public offering completed in April 2022 and proceeds from the exercise of currently outstanding warrants.

Financing activities in 2021 primarily reflect the receipt of net cash proceeds from the sales of our common stock under the 2020 Sales Agreement with B.

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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 2021 Form 10-K and there have been no changes to the contractual terms of our operating leases during the six months ended June 30, 2022.

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 preclinical research studies, investigator-led trials and other services and products for operating purposes.

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.

We have not considered these payments to be contractual obligations since the contracts are generally cancelable at any time by us upon less than 180 days’

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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