0000950170-24-123282 | 10-Q | XBRL Viewer

DEBT

9 Months Ended

Sep. 30, 2024

6. DEBT

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. (as successor to Silicon Valley Bank)), or SVB, entered into a term loan facility, or the Original Loan Agreement, consisting of up to $75.0 million aggregate principal amount available to us, as amended in August 2021. On June 30, 2022, or the Effective Date, we entered into a second amendment to the Original Loan Agreement, or as amended, the Hercules Loan Agreement. Under the second amendment, the aggregate principal amount available to us increased from $75.0 million to $125.0 million, with such principal being

available in a series of tranches, subject to certain terms and conditions. On December 14, 2023, we entered into a third amendment to the Hercules Loan Agreement. As of September 30, 2024, a total of $80.0 million had been drawn under the Hercules Loan Agreement.

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 drawdowns will be treated similarly. We also incurred 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.

Under the third amendment, the aggregate principal amount drawn down and remaining available to us under the Hercules Loan Agreement remained at $125.0 million at September 30, 2024, with such principal available in a series of tranches, subject to certain terms and conditions. The third amendment also provided that (i) the fourth tranche of the Hercules Loan Agreement was increased from $10.0 million to $30.0 million, (ii) the commitment period for the fifth tranche of the Hercules Loan Agreement of $20.0 million, which was made available due to achievement of a regulatory milestone and satisfaction of certain capitalization requirements and was extended through December 15, 2024, (iii) the variable annual interest rate on the outstanding loans was decreased to the greater of: (x) 9.0%, or (y) the sum of (A) the Prime Rate (as reported in The Wall Street Journal) minus 4.5%, plus (B) 9.0%; and (iv) the interest only period of the Hercules Loan Agreement was extended from June 30, 2024 through December 31, 2024, due to regulatory approval of RYTELO and satisfaction of certain financial and capitalization requirements. In connection with the third amendment, on the third amendment effective date, we borrowed and received the entire fourth tranche of the Hercules Loan Agreement in the amount of $30.0 million. After giving effect to such borrowing, the outstanding principal amount under the Hercules Loan Agreement was $80.0 million at September 30, 2024. On the effective date of the third amendment, we paid $300,000 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 drawdowns will be treated similarly. We also incurred legal fees in connection with the third amendment, which we recognize as debt issuance costs and amortize such cost to interest expense over the life of the loan using the effective interest rate method. The third amendment of the Hercules Loan Agreement was not substantially different as compared to the Original Loan Agreement, and accordingly, we treated the amendment as a modification of the debt in accordance with ASC 470. On September 15, 2023, the third tranche of $20.0 million of the Hercules Loan Agreement expired and was no longer available for us, but was added to the fourth tranche as part of the third amendment to the Hercules Loan Agreement.

Under the Hercules Loan Agreement as amended, the Hercules Loan Agreement matures on October 1, 2025, or the Loan Maturity Date, which was extended from April 1, 2025 upon regulatory approval of RYTELO. The Hercules Loan Agreement bears interest at a floating rate per annum equal to the greater of either (i) 9.0% or (ii) the sum of (A) the Prime Rate (as reported in The Wall Street Journal) minus 4.5%, plus (B) 9.0% (12.5% as of September 30, 2024). The interest only period of the Hercules Loan Agreement was extended from June 30, 2024 through December 31, 2024. due to regulatory approval of RYTELO and satisfaction of certain financial and capitalization requirements. Following the expiration of the interest-only period, we are required to repay the Hercules Loan Agreement in equal monthly amortization payments of principal and interest until the Loan Maturity Date. Upon full repayment of the Hercules Loan Agreement, we are also obligated to pay an end of term charge in an amount equal to 6.55% of the amount of the Hercules Loan Agreement actually borrowed. Such end of term charge is being accrued to interest expense over the term of the Loan Agreement using the effective interest rate method. At our option, upon at least seven business days’ prior written notice to Hercules, we are able to prepay all or any portion greater than or equal to $5.0 million of the outstanding loan by paying the entire principal balance (or portion thereof) and all accrued and unpaid interest. There was no prepayment charge for prepayments of drawdowns under Tranche 1 or Tranche 2. Prepayments of drawdowns under Tranche 3, Tranche 4, Tranche 5 or Tranche 6 are subject to a prepayment charge of 1.5% of the prepayment amount, if the prepayment is made prior to June 30, 2025. Thereafter, any prepayment of Tranche 3, Tranche 4, Tranche 5 or Tranche 6 is not subject to a prepayment charge. We were in compliance with the covenants under the Hercules Loan Agreement as of September 30, 2024.

As of September 30, 2024, the net carrying value of the debt under the Hercules Loan Agreement was $83.8 million, which includes the principal amount of $80.0 million less net unamortized debt discounts and issuance costs of $258,000 plus accrued end of term charge of $4.1 million. The carrying value of the debt approximates the fair value as of September 30, 2024. 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 September 30, 2024 (in thousands):


Remainder of 2024	$	2,548
2025		89,955
Total		92,503
Less: amount representing interest		(7,263	)
Less: unamortized debt discount and issuance costs		(258	)
Less: unaccrued end of term charge		(1,145	)
Less: current portion of debt		(71,562	)
Noncurrent portion of debt	$	12,275

Subsequent to September 30, 2024, all obligations outstanding under the Hercules Loan Agreement, amounting to $86.5 million, were repaid in full by us in connection with our entry into and funding under a new loan agreement, with BioPharma Credit PLC and the lenders party thereto. See Note 9 on Subsequent Events in Notes to Condensed Consolidated Financial Statements of this Report for additional information.

- Definition

The entire disclosure for information about short-term and long-term debt arrangements, which includes amounts of borrowings under each line of credit, note payable, commercial paper issue, bonds indenture, debenture issue, own-share lending arrangements and any other contractual agreement to repay funds, and about the underlying arrangements, rationale for a classification as long-term, including repayment terms, interest rates, collateral provided, restrictions on use of assets and activities, whether or not in compliance with debt covenants, and other matters important to users of the financial statements, such as the effects of refinancing and noncompliance with debt covenants.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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Reference 7: http://www.xbrl.org/2003/role/disclosureRef
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Reference 8: http://www.xbrl.org/2003/role/disclosureRef
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Reference 9: http://www.xbrl.org/2003/role/disclosureRef
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Reference 11: http://www.xbrl.org/2003/role/disclosureRef
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Reference 12: http://www.xbrl.org/2003/role/disclosureRef
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Reference 13: http://www.xbrl.org/2003/role/disclosureRef
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Reference 14: http://www.xbrl.org/2003/role/disclosureRef
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Reference 15: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

ACCRUED LIABILITIES (Tables)

9 Months Ended

Sep. 30, 2024

Payables and Accruals [Abstract]

Schedule of accrued liabilities

Accrued liabilities consisted of the following as of September 30, 2024 and December 31, 2023:


	SEPTEMBER 30,		DECEMBER 31,
(In thousands)	2024		2023
CRO and clinical trial costs	$	19,392	$	23,541
Manufacturing activities		12,326		14,629
Professional legal and accounting fees		751		556
Interest payable		853		768
Other		3,167		814
	$	36,489	$	40,308

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (Parenthetical) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2024	Mar. 31, 2023
Public Offering of Common Stock and Warrants
Issuance costs	$ 9,000	$ 14,507

REVENUE RECOGNITON (Tables)

9 Months Ended

Sep. 30, 2024

Revenue from Contract with Customer [Abstract]

Schedule of Reconciliation of Gross Product Sales to Net Product Sales

The reconciliation of gross product sales to net product sales by each significant category of gross-to-net adjustments was as follows for the three and nine months ended September 30, 2024 (in thousands):


	Three Months Ended			Nine Months Ended
	September 30,			September 30,
	(in thousands)			(in thousands)
Gross product revenue	$	32,657		$	33,547
Gross-to-net adjustments:
Chargebacks and distributor service fees		(4,002	)		(4,099	)
Government rebates		(364	)		(375	)
Sales returns and allowances		(82	)		(84	)
Total gross-to-net adjustments (1)	$	(4,448	)	$	(4,558	)
Net product revenue	$	28,209		$	28,989

(1)

As of September 30, 2024 approximately $1.4 million of estimated gross-to-net accruals have been recorded within accounts payable and accrued expenses on the condensed consolidated balance sheets.

FAIR VALUE MEASUREMENTS - SECURITY TYPE (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Included in cash and cash equivalents:
Amortized Cost	$ 36,824	$ 16,815
Gross Unrealized Gains	2
Estimated Fair Value	36,826	16,815
Restricted cash:
Amortized Cost	1,854	1,115
Estimated Fair Value	1,854	1,115
Marketable securities:
Amortized Cost	315,736	306,784
Gross Unrealized Gains	1,010	402
Gross Unrealized Losses	(4)	(212)
Estimated Fair Value	316,742	306,974
Money market funds
Included in cash and cash equivalents:
Amortized Cost	31,854	16,815
Estimated Fair Value	31,854	16,815
Restricted cash:
Amortized Cost	1,581	843
Estimated Fair Value	1,581	843
Commercial paper
Included in cash and cash equivalents:
Amortized Cost	4,970
Gross Unrealized Gains	2
Estimated Fair Value	4,972
Certificate of deposit
Restricted cash:
Amortized Cost	273	272
Estimated Fair Value	273	272
U.S. Treasury securities (due in less than one year)
Marketable securities:
Amortized Cost	35,481	26,752
Gross Unrealized Gains	56	95
Estimated Fair Value	35,537	26,847
U.S. Treasury securities (due in one to two years)
Marketable securities:
Amortized Cost		2,877
Gross Unrealized Gains		17
Estimated Fair Value		2,894
Government-sponsored enterprise securities (due in less than one year)
Marketable securities:
Amortized Cost	19,680	86,250
Gross Unrealized Gains	27	43
Gross Unrealized Losses		(92)
Estimated Fair Value	19,707	86,201
Government-sponsored enterprise securities (due in one to two years)
Marketable securities:
Amortized Cost	5,000	13,598
Gross Unrealized Gains		72
Estimated Fair Value	5,000	13,670
Commercial paper (due in less than one year)
Marketable securities:
Amortized Cost	135,717	102,270
Gross Unrealized Gains	327	31
Gross Unrealized Losses	(1)	(33)
Estimated Fair Value	136,043	102,268
Corporate notes (due in less than one year)
Marketable securities:
Amortized Cost	87,816	48,409
Gross Unrealized Gains	327	14
Gross Unrealized Losses	(2)	(63)
Estimated Fair Value	88,141	48,360
Corporate notes (due in one to two years)
Marketable securities:
Amortized Cost	32,042	26,628
Gross Unrealized Gains	273	130
Gross Unrealized Losses	(1)	(24)
Estimated Fair Value	$ 32,314	$ 26,734

SUBSEQUENT EVENTS

9 Months Ended

Sep. 30, 2024

Subsequent Events [Abstract]

SUBSEQUENT EVENTS

9. SUBSEQUENT EVENTS

Pharmakon Loan Agreement

On November 1, 2024, we entered into a loan agreement, or the Pharmakon Loan Agreement, with BioPharma Credit Investments V (Master) LP and BPCR Limited Partnership, each, a Lender, which are investment funds managed by Pharmakon Advisors, LP, and BioPharma Credit PLC, as collateral agent, that provides for a 5-year senior secured term loan facility of up to $250.0 million, divided into three committed tranches: (i) a Tranche A Loan in an aggregate principal amount of $125.0 million, or the Tranche A Loan, which was funded on November 1, 2024, or the Tranche A Closing Date; (ii) a Tranche B Loan in an aggregate principal amount of $75.0 million, or the Tranche B Loan, which is available, subject to certain limited conditions, at our option; and (iii) a Tranche C Loan in an aggregate principal amount of $50.0 million, or the Tranche C Loan, and together with the Tranche A Loan and the Tranche B Loan, collectively, the Term Loans, which is available to us upon reaching a specified trailing twelve-month RYTELO revenue milestone. The Tranche B Loan and the Tranche C Loan, once available, may be requested on or prior to December 31, 2025. A portion of the proceeds from the Tranche A Loan were used to repay, in full, all amounts owed ($86.5 million) under the Hercules Loan Agreement, which was terminated effective November 1, 2024. The remaining proceeds will be used to fund our general corporate and working capital requirements.

The Term Loans mature on November 1, 2029. The Term Loans bear interest at a variable rate per annum equal to 5.75% plus the three-month Secured Overnight Financing Rate, or SOFR, with a SOFR floor of 3.00%. As of inception of the Tranche A Loan, the interest rate applicable to the Tranche A Loan was 10.32%. Interest is due and payable quarterly on the last day of each quarter with the first payment due on December 31, 2024. The Pharmakon Loan Agreement requires we pay an amount equal to 2.50% of the Lenders’ total committed amount to fund the Term Loans, payable with respect to each Term Loan on the funding date of such Term Loan.

We may elect to prepay the Term Loans in part or in whole prior to the Maturity Date with such prepayments being subject to a prepayment premium equal to the principal amount so prepaid multiplied by 3% if made prior to the 3rd anniversary of the funding date of the applicable Term Loan, 2% if made on or after the 3rd anniversary of the funding date of the applicable Term Loan but prior to the 4th anniversary of the funding date of the applicable Term Loan, and 1% if made on or after the 4th anniversary of the funding date of the applicable Term Loan but prior to the Maturity Date. In addition to the prepayment premium, prepayments of any Term Loan prior to the 2nd anniversary of the funding date of such Term Loan are subject to a makewhole amount equal to the sum of all interest that would have accrued through such 2nd anniversary.

Our obligations under the Pharmakon Loan Agreement are secured by substantially all of our assets, including our intellectual property. Certain of our subsidiaries may, from time to time after the Tranche A Closing Date, be required to guarantee our obligations under the Pharmakon Loan Agreement and, in connection with such guarantee, pledge substantially all of their assets, including intellectual property, to secure such guarantee.

The Pharmakon Loan Agreement contains customary affirmative and restrictive covenants and representations and warranties. We and our subsidiaries are bound by certain affirmative covenants setting forth actions that are required during the term of the Pharmakon Loan Agreement, including, without limitation, certain information delivery requirements, obligations to maintain certain insurance, and certain notice requirements. There are no financial covenants. Additionally, we and our subsidiaries are bound by certain restrictive covenants setting forth actions that are not permitted to be taken during the term of the Pharmakon Loan Agreement, including, without limitation, (i) selling or disposing of assets, (ii) amending, modifying or waiving our rights under material agreements, (iii) consummating change in control transactions unless all amounts becoming due under the Loan Agreement are paid in full immediately upon (and concurrent with) the consummation of any such change in control transaction, (iv) incurring additional indebtedness, (v) incurring non-permitted liens or encumbrance on our or our subsidiaries’ assets, (vi) paying dividends or making any distribution or payment on or redeeming, retiring or purchasing any equity interests, and (vii) making payments on subordinated indebtedness, in each case, subject to specified exceptions. The Pharmakon Loan Agreement also contains the following events of default: (i) failure to pay principal, interest and other amounts when due, (ii) the breach of the covenants under the Loan Agreement, (iii) the occurrence of a material adverse change or a withdrawal event in respect of RYTELO, (iv) certain attachments of the credit parties assets and restraints on their business, (v) certain insolvency, liquidation, bankruptcy or similar events, (vi) certain cross-default of third-party indebtedness and royalty revenue contracts, (vii) the failure to pay certain judgements, (viii) material misrepresentations, (ix) the loan documents ceasing to create a valid security interest in a material portion of the collateral, (x) the occurrence of certain ERISA events and (xi) the occurrence of a default under any subordination or intercreditor agreement, in each case subject to the grace periods, cure period and thresholds as specified in the Pharmakon Loan Agreement. Upon the occurrence of an event of default, the Lenders may, among other things, accelerate our obligations under the Pharmakon Loan Agreement (including all obligations for principal, interest and any applicable makewhole and prepayment premiums); provided that upon an event of default relating to certain insolvency, liquidation, bankruptcy or similar events, all outstanding obligations will be immediately accelerated.

Termination of the Hercules Loan Agreement

All obligations outstanding under the Hercules Loan Agreement were repaid in full on November 1, 2024, upon which the Hercules Loan Agreement was terminated and all liens on our assets in granted in connection with the Hercules Loan Agreement were released. See Note 6 on Debt in Notes to Condensed Consolidated Financial Statements of this Report for additional information about the Hercules Loan Agreement.

Royalty Pharma Revenue Participation Right Purchase Agreement

On November 1, 2024, we entered into a revenue participation right purchase and sale agreement, or the Royalty Pharma Agreement, with Royalty Pharma Development Funding, LLC, or Royalty Pharma.

Pursuant to the Royalty Pharma Agreement, we received an upfront payment of $125.0 million, or the Purchase Price, in exchange for which Royalty Pharma obtained the right to receive tiered revenue interest payments with respect to annual U.S. net sales, or Annual Net Sales, of RYTELO beginning on July 1, 2024, ranging from: (i) 7.75% of Annual Net Sales up to $500.0 million; (ii) 3.0% of Annual Net Sales in excess of $500.0 million but less than or equal to $1.0 billion; and (iii) 1.0% in respect of Annual Net Sales in excess of $1.0 billion, or the Revenue Interest Payments. The Revenue Interest Payments to Royalty Pharma are capped, such that they will cease upon reaching a multiple of 1.65 times the Purchase Price if Royalty Pharma receives Revenue Interest Payments in that amount in respect of net sales occurring on or before June 30, 2031, or upon reaching a multiple of 2.0 times the Purchase Price thereafter. Our revenue payment obligations under the Royalty Pharma Agreement may be discharged in connection with a change of control of the Company in an amount equal to 1.65 times the Purchase Price minus the aggregate Revenue Interest Payments received by Royalty Pharma as of the date of the closing of the change of control, if the closing of the change of control occurs on or prior to December 31, 2027, or in an amount equal to 2.0 times the Purchase Price minus the aggregate Revenue Interest Payments received by Royalty Pharma as of the date of the closing of the change of control, if the closing of the change of control occurs after December 31, 2027. There are no other royalties payable on RYTELO, which was developed internally and is exclusively owned by Geron.

The Royalty Pharma Agreement contains customary representations, warranties and indemnities of the Company and Royalty Pharma and customary covenants relating to the Revenue Interest Payments.

STOCKHOLDERS' EQUITY - REGISTERED OFFERING (Details) - 2024 Underwritten Public Offering $ / shares in Units, $ in Millions	Mar. 21, 2024 USD ($) $ / shares shares
Public Offering [Line Items]
Issuance of common stock in connection with public offering (in shares) \| shares	41,999,998
Net cash proceeds from public offering after deducting underwriting discount and other offering expenses \| $	$ 141.0
Common Stock
Public Offering [Line Items]
Public offering price of common stock per share	$ 3
2024 Pre-funded Warrant
Public Offering [Line Items]
Warrant to purchase common stock, shares \| shares	8,002,668
Public offering price per share	$ 2.99
Warrant exercise price	$ 0.001

ACCRUED LIABILITIES

9 Months Ended

Sep. 30, 2024

Payables and Accruals [Abstract]

ACCRUED LIABILITIES

5. ACCRUED LIABILITIES

Accrued liabilities consisted of the following as of September 30, 2024 and December 31, 2023:


	SEPTEMBER 30,		DECEMBER 31,
(In thousands)	2024		2023
CRO and clinical trial costs	$	19,392	$	23,541
Manufacturing activities		12,326		14,629
Professional legal and accounting fees		751		556
Interest payable		853		768
Other		3,167		814
	$	36,489	$	40,308

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - STOCK OPTIONS AND EMPLOYEE STOCK PURCHASE PLAN (Details)	9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
Stock Options
Stock-Based Compensation
Vesting period of awards	4 years
Assumptions used to estimate fair value of awards
Dividend yield (as a percent)	0.00%	0.00%
Expected volatility range, minimum (as a percent)	82.94%	81.53%
Expected volatility range, maximum (as a percent)	86.68%	82.12%
Risk-free interest rate range, minimum (as a percent)	3.53%	3.42%
Risk-free interest rate range, maximum (as a percent)	4.62%	4.62%
Expected term	6 years	6 years
Employee Stock Purchase Plan
Assumptions used to estimate fair value of awards
Dividend yield (as a percent)	0.00%	0.00%
Expected volatility range, minimum (as a percent)	72.08%	79.05%
Expected volatility range, maximum (as a percent)	119.00%	83.22%
Risk-free interest rate range, minimum (as a percent)	4.79%	4.73%
Risk-free interest rate range, maximum (as a percent)	5.37%	5.40%
Employee Stock Purchase Plan \| Minimum
Assumptions used to estimate fair value of awards
Expected term	6 months	6 months
Employee Stock Purchase Plan \| Maximum
Assumptions used to estimate fair value of awards
Expected term	12 months	12 months

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - ANTI-DILUTIVE SHARES (Details) - shares	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Stock options and warrants excluded from diluted net loss per share calculation due to net loss position
Antidilutive Securities Excluded from Computation of Earnings Per Share
Potential dilutive securities excluded from diluted earnings (loss) per share calculation (in shares)	76,588,779	77,651,673	76,588,779	77,651,673

Insider Trading Arrangements

3 Months Ended

Sep. 30, 2024

Trading Arrangements, by Individual

Material Terms of Trading Arrangement

During the quarter ended September 30, 2024, our directors and officers (as defined in Rule 16a-1(f) under the Exchange Act) adopted or terminated the contracts, instructions or written plans for the purchase or sale of our securities set forth in the table below.


			Character of Trading Arrangement
Name and Title	Action	Date	Rule 10b5-1*	Non-Rule 10b5-1**	Total Shares to be Sold	Expiration Date
Faye M. Feller, M.D., Executive Vice President and Chief Medical Officer	Adoption	July 12, 2024	X		974,1671	June 30, 2025
Andrew J. Grethlein, Ph.D., Executive Vice President and Chief Operating Officer	Adoption	July 12, 2024	X		1,279,9852	November 14, 2025
John A. Scarlett, M.D., Chairman of the Board, President and Chief Executive Officer	Adoption	July 12, 2024	X		1,374,2983	July 11, 2025
Anil Kapur Executive Vice President, Corporate Strategy, and Chief Commercial Officer (until August 31, 2024)	Adoption	July 9, 2024	X		1,587,5004	June 27, 2025
* Contract, instruction or written plan intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) under the Exchange Act.
** "Non-Rule 10b5-1 trading arrangement" as defined in Item 408(c) of Regulation S-K under the Exchange Act.

1 Consists of 974,167 shares subject to stock options previously granted by Geron to Dr. Feller.

2 Consists of 1,279,985 shares subject to stock options previously granted by Geron to Dr. Grethlein.

3 Consists of 1,374,298 shares subject to stock options previously granted by Geron to Dr. Scarlett.

4 Mr. Kapur's employment with Geron terminated on August 31, 2024. Consists of 1,587,500 shares subject to stock options previously granted by Geron to Mr. Kapur.

Faye M. Feller, M.D.

Trading Arrangements, by Individual

Name

Faye M. Feller, M.D.

Title

Executive Vice President and Chief Medical Officer

Rule 10b5-1 Arrangement Adopted

true

Non-Rule 10b5-1 Arrangement Adopted

false

July 12, 2024

June 30, 2025

354 days

974,167

^[1]

Andrew J. Grethlein, Ph.D.

Trading Arrangements, by Individual

Name

Andrew J. Grethlein, Ph.D.

Title

Executive Vice President and Chief Operating Officer

Rule 10b5-1 Arrangement Adopted

true

Non-Rule 10b5-1 Arrangement Adopted

false

July 12, 2024

November 14, 2025

491 days

1,279,985

^[2]

John A. Scarlett, M.D.

Trading Arrangements, by Individual

Name

John A. Scarlett, M.D.

Title

Chairman of the Board, President and Chief Executive Officer

Rule 10b5-1 Arrangement Adopted

true

Non-Rule 10b5-1 Arrangement Adopted

false

July 12, 2024

July 11, 2025

365 days

1,374,298

^[3]

Anil Kapur

Trading Arrangements, by Individual

Name

Anil Kapur

Title

Executive Vice President, Corporate Strategy, and Chief Commercial Officer

Rule 10b5-1 Arrangement Adopted

true

Non-Rule 10b5-1 Arrangement Adopted

false

July 9, 2024

June 27, 2025

354 days

1,587,500

^[4]

[1]	Consists of 974,167 shares subject to stock options previously granted by Geron to Dr. Feller.
[2]	Consists of 1,279,985 shares subject to stock options previously granted by Geron to Dr. Grethlein.
[3]	Consists of 1,374,298 shares subject to stock options previously granted by Geron to Dr. Scarlett.
[4]	Mr. Kapur's employment with Geron terminated on August 31, 2024. Consists of 1,587,500 shares subject to stock options previously granted by Geron to Mr. Kapur.

FAIR VALUE MEASUREMENTS - SECURITIES WITH UNREALIZED LOSSES (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Schedule Of Available For Sale Securities [Line Items]
Less Than 12 Months - Estimated Fair Value	$ 12,842	$ 166,518
Less Than 12 Months - Gross Unrealized Losses	(2)	(211)
12 Months or Longer - Estimated Fair Value	1,986
12 Months or Longer - Gross Unrealized Losses	(2)
Total - Estimated Fair Value	14,828	166,518
Total - Gross Unrealized Losses	(4)	(211)
Government-sponsored enterprise securities (due in less than one year)
Schedule Of Available For Sale Securities [Line Items]
Less Than 12 Months - Estimated Fair Value		69,377
Less Than 12 Months - Gross Unrealized Losses		(92)
Total - Estimated Fair Value		69,377
Total - Gross Unrealized Losses		(92)
Commercial paper (due in less than one year)
Schedule Of Available For Sale Securities [Line Items]
Less Than 12 Months - Estimated Fair Value	10,929	58,622
Less Than 12 Months - Gross Unrealized Losses		(33)
Total - Estimated Fair Value	10,929	58,622
Total - Gross Unrealized Losses		(33)
Corporate notes (due in less than one year)
Schedule Of Available For Sale Securities [Line Items]
Less Than 12 Months - Estimated Fair Value		34,567
Less Than 12 Months - Gross Unrealized Losses		(63)
12 Months or Longer - Estimated Fair Value	1,986
12 Months or Longer - Gross Unrealized Losses	(2)
Total - Estimated Fair Value	1,986	34,567
Total - Gross Unrealized Losses	(2)	(63)
Corporate notes (due in one to two years)
Schedule Of Available For Sale Securities [Line Items]
Less Than 12 Months - Estimated Fair Value	1,913	3,952
Less Than 12 Months - Gross Unrealized Losses	(2)	(23)
Total - Estimated Fair Value	1,913	3,952
Total - Gross Unrealized Losses	$ (2)	$ (23)

STOCKHOLDERS' EQUITY - WARRANT EXERCISES (Details) - USD ($)	3 Months Ended			9 Months Ended
	Sep. 30, 2024	Jun. 30, 2024	Mar. 31, 2024	Sep. 30, 2024	Sep. 30, 2023
Class of Warrant or Right [Line Items]
Proceeds from exercise of warrants				$ 418,000	$ 105,912,000
Pre-Funded Warrants
Class of Warrant or Right [Line Items]
Warrant exercise price	$ 0.001			$ 0.001
Common stock outstanding warrants to purchase	59,433,145			59,433,145
2020 Public Offering of Common Stock and Warrants \| Stock Purchase Warrants
Class of Warrant or Right [Line Items]
Warrant exercise price	$ 1.3			$ 1.3
Common stock outstanding warrants to purchase	2,152,570			2,152,570
Warrants expiration date	Dec. 31, 2025			Dec. 31, 2025
Underwritten Public Offering \| Stock Purchase Warrants
Class of Warrant or Right [Line Items]
Warrants to purchase common stock exercised, shares	3,080	281,211	37,640	3,080
Proceeds from exercise of warrants	$ 4,000	$ 365,000	$ 49,000

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - USEFUL LIVES OF ASSETS (Details)	Sep. 30, 2024
Depreciation [Abstract]
Estimated useful lives of assets	4 years

INVENTORY

9 Months Ended

Sep. 30, 2024

Inventory Disclosure [Abstract]

INVENTORY

3. INVENTORY

All of our inventories are related to the manufacturing of RYTELO. The following table presents our inventory as of September 30, 2024 (in thousands):



	As of September 30, 2024
	(in thousands)
Raw materials	$	5,871
Work-in-process		13,544
Finished goods		868
Total inventory	$	20,283

REVENUE RECOGNITON - Schedule of Reconciliation of Gross Product Sales to Net Product Sales (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Disaggregation of Revenue [Line Items]
Product revenue, net	$ 28,271	$ 164	$ 29,457	$ 214
Revenues Before Adjustments
Disaggregation of Revenue [Line Items]
Product revenue, net	32,657		33,547
Chargebacks and distributor service fees
Disaggregation of Revenue [Line Items]
Product revenue, net	(4,002)		(4,099)
Government rebates
Disaggregation of Revenue [Line Items]
Product revenue, net	(364)		(375)
Sales returns and allowances
Disaggregation of Revenue [Line Items]
Product revenue, net	(82)		(84)
Total gross-to-net adjustments
Disaggregation of Revenue [Line Items]
Product revenue, net	(4,448)		(4,558)
Product Revenue, Net
Disaggregation of Revenue [Line Items]
Product revenue, net	$ 28,209		$ 28,989

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References + Details

- Definition

Amount, excluding tax collected from customer, of revenue from satisfaction of performance obligation by transferring promised good or service to customer. Tax collected from customer is tax assessed by governmental authority that is both imposed on and concurrent with specific revenue-producing transaction, including, but not limited to, sales, use, value added and excise.

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+ Details

INVENTORY (Tables)

9 Months Ended

Sep. 30, 2024

Inventory Disclosure [Abstract]

Schedule of Inventory

The following table presents our inventory as of September 30, 2024 (in thousands):



	As of September 30, 2024
	(in thousands)
Raw materials	$	5,871
Work-in-process		13,544
Finished goods		868
Total inventory	$	20,283

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Revenues:
Total revenues	$ 28,271	$ 164	$ 29,457	$ 214
Operating expenses:
Cost of goods sold	456		473
Research and development	20,153	29,426	80,305	92,135
Selling, general and administrative	35,877	18,350	102,361	47,734
Total operating expenses	56,486	47,776	183,139	139,869
Loss from operations	(28,215)	(47,612)	(153,682)	(139,655)
Interest income	4,877	4,965	14,448	13,556
Interest expense	(3,046)	(2,066)	(9,798)	(5,991)
Other income and (expense), net	(63)	(92)	(188)	(64)
Net loss	$ (26,447)	$ (44,805)	$ (149,220)	$ (132,154)
Basic net loss per share	$ (0.04)	$ (0.08)	$ (0.23)	$ (0.23)
Diluted net loss per share	$ (0.04)	$ (0.08)	$ (0.23)	$ (0.23)
Shares used in computing basic net loss per share	662,158,182	579,508,305	639,933,612	562,445,577
Shares used in computing diluted net loss per share	662,158,182	579,508,305	639,933,612	562,445,577
Product Revenue, Net
Revenues:
Total revenues	$ 28,209		$ 28,989
Royalties
Revenues:
Total revenues	$ 62	$ 164	$ 468	$ 214

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Statement of Comprehensive Income [Abstract]
Net loss	$ (26,447)	$ (44,805)	$ (149,220)	$ (132,154)
Net unrealized gain/ (loss) on marketable securities	1,507	(11)	816	(722)
Foreign currency translation adjustments	48	6	17	(9)
Comprehensive loss	$ (24,892)	$ (44,810)	$ (148,387)	$ (132,885)

- Definition

Amount after tax of increase (decrease) in equity from transactions and other events and circumstances from net income and other comprehensive income, attributable to parent entity. Excludes changes in equity resulting from investments by owners and distributions to owners.

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- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

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Reference 31: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1B
-Subparagraph (SX 210.13-02(a)(5))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147480097/470-10-S99-1B

Reference 32: http://www.xbrl.org/2003/role/disclosureRef
-Topic 260
-SubTopic 10
-Name Accounting Standards Codification
-Section 45
-Paragraph 60B
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482689/260-10-45-60B

Reference 33: http://www.xbrl.org/2003/role/disclosureRef
-Topic 205
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 7
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147483499/205-20-50-7

Reference 34: http://fasb.org/us-gaap/role/ref/legacyRef
-Topic 230
-SubTopic 10
-Name Accounting Standards Codification
-Section 45
-Paragraph 28
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482740/230-10-45-28

Reference 35: http://www.xbrl.org/2003/role/disclosureRef
-Topic 220
-SubTopic 10
-Name Accounting Standards Codification
-Section 45
-Paragraph 1A
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482790/220-10-45-1A

Reference 36: http://www.xbrl.org/2003/role/disclosureRef
-Topic 220
-SubTopic 10
-Name Accounting Standards Codification
-Section 45
-Paragraph 1B
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482790/220-10-45-1B

Reference 37: http://fasb.org/us-gaap/role/ref/legacyRef
-Topic 942
-SubTopic 220
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.9-04(22))
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147478524/942-220-S99-1

+ Details

REVENUE RECOGNITON - Schedule of Gross-to-Net Sales Adjustments (Parenthetical) (Details) $ in Millions	Sep. 30, 2024 USD ($)
Total gross-to-net adjustments
Disaggregation of Revenue [Line Items]
Accounts payable and accrued expenses	$ 1.4

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References + Details

ACCRUED LIABILITIES (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Payables and Accruals [Abstract]
CRO and clinical trial costs	$ 19,392	$ 23,541
Manufacturing activities	12,326	14,629
Professional legal and accounting fees	751	556
Interest payable	853	768
Other	3,167	814
Accrued liabilities	$ 36,489	$ 40,308

DOCUMENT AND ENTITY INFORMATION - shares	9 Months Ended
DOCUMENT AND ENTITY INFORMATION - shares	Sep. 30, 2024	Nov. 04, 2024
Cover [Abstract]
Entity Registrant Name	GERON CORP
Entity Central Index Key	0000886744
Document Type	10-Q
Document Period End Date	Sep. 30, 2024
Amendment Flag	false
Current Fiscal Year End Date	--12-31
Entity Current Reporting Status	Yes
Entity Filer Category	Large Accelerated Filer
Entity Small Business	false
Entity Emerging Growth Company	false
Entity Common Stock, Shares Outstanding		604,501,016
Document Fiscal Year Focus	2024
Document Fiscal Period Focus	Q3
Trading Symbol	GERN
Entity File Number	000-20859
Entity Tax Identification Number	75-2287752
Entity Shell Company	false
Entity Address, Address Line One	919 EAST HILLSDALE BOULEVARD
Entity Address, Address Line Two	SUITE 250
Entity Address, City or Town	FOSTER CITY
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	94404
City Area Code	650
Local Phone Number	473-7700
Entity Interactive Data Current	Yes
Title of 12(b) Security	Common Stock, $0.001 par value
Security Exchange Name	NASDAQ
Entity Incorporation, State or Country Code	DE
Document Quarterly Report	true
Document Transition Report	false

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables)

9 Months Ended

Sep. 30, 2024

Organization, Consolidation and Presentation of Financial Statements [Abstract]

Summary of allocation of stock-based compensation expense included in operating expenses on condensed consolidated statements of operations related to share-based payment awards

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, 2024 and 2023, which was allocated as follows:


	Three Months Ended September 30,				Nine Months Ended September 30,
(In thousands)	2024		2023		2024		2023
Research and development	$	1,904	$	2,951	$	7,960	$	5,847
Selling, general and administrative		4,986		4,253		16,432		8,263
Total stock-based compensation expense	$	6,890	$	7,204	$	24,392	$	14,110

Stock-based compensation of $0.3 million and $0.4 million was capitalized to inventory for the three and nine months ended September 30, 2024, respectively.

Schedule of assumptions used to estimate the fair value of service-based stock options granted

The fair value of service-based stock options granted during the nine months ended September 30, 2024 and 2023 has been estimated at the date of grant using the Black- Scholes option-pricing model with the following assumptions:


	Nine Months Ended September 30,
	2024	2023
Dividend yield	0%	0%
Expected volatility range	82.94% to 86.68%	81.53% to 82.12%
Risk-free interest rate range	3.53% to 4.62%	3.42% to 4.62%
Expected term	6 years	6 years

Schedule of assumptions used to estimate the fair value of employee stock purchases under the purchase plan

The fair value of employees’ stock purchase rights during the nine months ended September 30, 2024 and 2023 has been estimated using the Black-Scholes option-pricing model with the following assumptions:


	Nine Months Ended September 30,
	2024	2023
Dividend yield	0%	0%
Expected volatility range	72.08% to 119%	79.05% to 83.22%
Risk-free interest rate range	4.79% to 5.37%	4.73% to 5.40%
Expected term range	6 months to 12 months	6 months to 12 months

CONTINGENCIES AND UNCERTAINTIES

9 Months Ended

Sep. 30, 2024

Commitments and Contingencies Disclosure [Abstract]

CONTINGENCIES AND UNCERTAINTIES

7. CONTINGENCIES AND UNCERTAINTIES

Legal Proceedings

We are not currently a party to any material pending legal proceedings. From time to time, we may and have previously been involved in legal proceedings arising in the ordinary course of business, including potential securities lawsuits. Such lawsuits are subject to inherent uncertainties, and the actual defense and disposition costs will depend upon many unknown factors. We could be forced to expend significant resources in the defense of any additional lawsuits, and we may not prevail. Monitoring, initiating and defending against legal actions is time-consuming for our management, is likely to be expensive, and may detract from our ability to fully focus our internal resources on our business activities. We could be forced to expend significant resources in any potential future lawsuits, and we may not prevail in such lawsuits. Additionally, we may not be successful in having any such lawsuits dismissed or settled within the limits of our insurance coverage. Expenses associated with any potential future lawsuits could be material to our consolidated financial statements if we do not prevail in the defense of such lawsuits, or even if we do prevail. We have not established any reserve for any potential liability relating to any potential future lawsuits. It is possible that we could, in the future, incur judgments or enter into settlements of claims for monetary damages.

Indemnifications to Officers and Directors

Our corporate bylaws require that we indemnify our directors, as well as those who act as directors and officers of other entities at our request, against expenses, judgments, fines, settlements and other amounts actually and reasonably incurred in connection with any proceedings arising out of their services to Geron. In addition, we have entered into separate indemnification agreements with each of our directors and officers which provide for indemnification of these directors and officers under similar circumstances and under additional circumstances. The indemnification obligations are more fully described in our bylaws and the indemnification agreements. We purchase standard insurance to cover claims or a portion of the claims made against our directors and officers. Since a maximum obligation is not explicitly stated in our bylaws or in our indemnification agreements and will depend on the facts and circumstances that arise out of any future claims, the overall maximum amount of the obligations cannot be reasonably estimated.

Severance Plan

We have adopted two severance plans that apply to all of our employees who are not subject to performance improvement plans, one plan covering employees above the Vice President level, i.e., executives, and all other employees hired before January 1, 2022, and the other plan covering all non-executive employees hired on or after January 1, 2022. The severance plans provide for, among other benefits: (i) a severance payment upon a Change of Control Triggering Event and Separation from Service and (ii) a severance payment for each non‑executive employee upon a Non‑Change of Control Triggering Event and Separation from Service. As defined in the severance plans, a Change of Control Triggering Event and Separation from Service requires a “double trigger” where: (i) an employee is terminated by us without cause in connection with a change of control or within 12 months following a change of control provided, however, that if an employee is terminated by us in connection with a change of control but immediately accepts employment with our successor or acquirer, the employee will not be eligible for the benefits outlined in the plans, (ii) an employee resigns because in connection with a change of control, the offered terms of employment (new or continuing) by us or our successor or acquirer within 30 days after the change of control results in a material change in the terms of employment, or (iii) after accepting (or continuing) employment with us after a change of control, an employee resigns within 12 months following a change of control due to a material change in the terms of employment. Under the severance plans, a Non‑Change of Control Triggering Event and Separation

from Service is defined as an event where an employee is terminated by us without cause. Severance payments range from three to 18 months of base salary in connection with a Change of Control Triggering Event or from six weeks to 12 months of base salary in connection with a Non-Change of Control Triggering Event, as well as a pro-rata portion of the employee’s annual target bonus, depending on the employee’s position with us, payable in a lump sum payment, and monthly COBRA payments for the severance period. The severance plans also provide that they shall not supersede the provisions of any individual employment agreements entered into between us and our employees, and that the employees with such agreements will be entitled to whichever benefits are greater under the severance plan or their employment agreement. A copy of the severance plan covering our executive officers is filed as an exhibit to the 2023 Form 10-K. As of September 30, 2024, all our executive officers have employment agreements with severance provisions and will receive the greater severance benefits of their agreements or those in the severance plan applicable to them.

Purchase Commitments

We have engaged third‑party contract manufacturers and have re-established our own manufacturing supply chain to manufacture and supply additional quantities of RYTELO that meet applicable regulatory standards for current and potential future clinical trials and commercial uses. Related to those contract manufacturing agreements, we have noncancelable commercial purchase commitments for approximately $62.4 million in the aggregate as of September 30, 2024. These purchase commitments can vary based on the commercial demand of RYTELO and are binding based on future manufacturing needs.

In the normal course of business, we enter into agreements with CROs for clinical trials for clinical and commercial 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 cancellable at any time by us upon less than 180 days’ prior written notice. We also have certain in-license agreements that require us to pay milestones to such third parties upon achievement of certain development, regulatory or commercial milestones. Amounts related to contingent milestone payments are not considered contractual obligations as they are contingent on the successful achievement of certain development, regulatory approval and commercial milestones, which may not be achieved.

FAIR VALUE MEASUREMENTS (Tables)

9 Months Ended

Sep. 30, 2024

Fair Value Disclosures [Abstract]

Schedule of cash equivalents, restricted cash and marketable securities by security type

Cash equivalents, restricted cash and marketable securities by security type at September 30, 2024 were as follows:


			Gross		Gross
	Amortized		Unrealized		Unrealized			Estimated
(In thousands)	Cost		Gains		Losses			Fair Value
Included in cash and cash equivalents:
Money market funds	$	31,854	$	—	$	—		$	31,854
Commercial paper		4,970		2		—		$	4,972
	$	36,824	$	2	$	—		$	36,826

Restricted cash:
Money market fund	$	1,581	$	—	$	—		$	1,581
Certificate of deposit		273		—		—			273
	$	1,854	$	—	$	—		$	1,854

Marketable securities:
U.S. Treasury securities (due in less than one year)	$	35,481	$	56	$	—		$	35,537
Government-sponsored enterprise securities (due in less than one year)		19,680		27		—			19,707
Government-sponsored enterprise securities (due in one to two years)		5,000		—		—			5,000
Commercial paper (due in less than one year)		135,717		327		(1	)		136,043
Corporate notes (due in less than one year)		87,816		327		(2	)		88,141
Corporate notes (due in one to two years)		32,042		273		(1	)		32,314
	$	315,736	$	1,010	$	(4	)	$	316,742

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


			Gross		Gross
	Amortized		Unrealized		Unrealized			Estimated
(In thousands)	Cost		Gains		Losses			Fair Value
Included in cash and cash equivalents:
Money market funds	$	16,815	$	—	$	—		$	16,815
	$	16,815	$	—	$	—		$	16,815

Restricted cash:
Money market fund	$	843	$	—	$	—		$	843
Certificate of deposit		272		—		—			272
	$	1,115	$	—	$	—		$	1,115

Marketable securities:
U.S. Treasury securities (due in less than one year)	$	26,752	$	95	$	—		$	26,847
U.S. Treasury securities (due in one to two years)		2,877		17		—			2,894
Government-sponsored enterprise securities (due in less than one year)		86,250		43		(92	)		86,201
Government-sponsored enterprise securities (due in one to two years)		13,598		72		—			13,670
Commercial paper (due in less than one year)		102,270		31		(33	)		102,268
Corporate notes (due in less than one year)		48,409		14		(63	)		48,360
Corporate notes (due in one to two years)		26,628		130		(24	)		26,734
	$	306,784	$	402	$	(212	)	$	306,974

Schedule of cash equivalents and marketable securities with unrealized losses

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, 2024 and December 31, 2023 were as follows:


	Less Than 12 Months					12 Months or Longer					Total
			Gross					Gross					Gross
	Estimated		Unrealized			Estimated		Unrealized			Estimated		Unrealized
(In thousands)	Fair Value		Losses			Fair Value		Losses			Fair Value		Losses
As of September 30, 2024:
Commercial paper (due in less than one year)	$	10,929	$	—		$	—	$	—		$	10,929	$	—
Corporate notes (due in less than one year)		—		—			1,986		(2	)		1,986		(2	)
Corporate notes (due in one to two years)		1,913		(2	)		—		—			1,913		(2	)
	$	12,842	$	(2	)	$	1,986	$	(2	)	$	14,828	$	(4	)

As of December 31, 2023:
Government-sponsored enterprise securities (due in less than one year)	$	69,377	$	(92	)	$	—	$	—		$	69,377		(92	)
Commercial paper (due in less than one year)		58,622		(33	)		—		—			58,622		(33	)
Corporate notes (due in less than one year)		34,567		(63	)		—		—			34,567		(63	)
Corporate notes (due in one to two years)		3,952		(23	)		—		—			3,952		(23	)
	$	166,518	$	(211	)	$	—	$	—		$	166,518	$	(211	)

Schedule of financial instruments measured at fair value on recurring basis

The following table presents information about our financial instruments that are measured at fair value on a recurring basis as of September 30, 2024 and December 31, 2023 and indicates the fair value category assigned.


	Fair Value Measurements at Reporting Date Using
	Quoted Prices in				Significant
	Active Markets for		Significant Other		Unobservable
	Identical Assets		Observable Inputs		Inputs
(In thousands)	Level 1		Level 2		Level 3		Total
As of September 30, 2024:
Money market funds(1)(2)	$	33,435	$	—	$	—	$	33,435
Certificate of deposit(2)		273		—		—		273
U.S. Treasury securities(3)		—		35,536		—		35,536
Government-sponsored enterprise securities(3)(4)		—		24,707		—		24,707
Commercial paper(3)		—		141,015		—		141,015
Corporate notes(3)(4)		—		120,454		—		120,454
Total	$	33,708	$	321,712	$	—	$	355,420
As of December 31, 2023:
Money market funds(1)(2)	$	17,658	$	—	$	—	$	17,658
Certificate of deposit(2)		272		—		—		272
U.S. Treasury securities(3)(4)		—		29,742		—		29,742
Government-sponsored enterprise securities(3)(4)		—		99,872		—		99,872
Commercial paper(3)		—		102,268		—		102,268
Corporate notes(3)(4)		—		75,092		—		75,092
Total	$	17,930	$	306,974	$	—	$	324,904

(1)

Included in cash and cash equivalents on our condensed consolidated balance sheets.

(2)

Included in restricted cash on our condensed consolidated balance sheets.

(3)

Included in current portion of marketable securities on our condensed consolidated balance sheets.

(4)

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

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023
Cash flows from operating activities:
Net loss	$ (149,220)	$ (132,154)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization	404	328
Accretion and amortization on investments, net	(7,281)	(8,335)
Amortization of debt issuance costs/debt discounts	1,894	742
Stock-based compensation for services by non-employees	122	650
Stock-based compensation for employees and directors	24,392	14,110
Amortization of right-of-use assets	501	464
Changes in assets and liabilities:
Inventory	(20,283)
Accounts receivable, net	(28,007)
Prepaid expenses, interest receivable and other assets	(1,842)	(13,694)
Current and noncurrent liabilities	4,647	11,084
Net cash used in operating activities	(174,673)	(126,805)
Cash flows from investing activities:
Purchases of property and equipment	(821)	(766)
Purchases of marketable securities	(292,141)	(459,727)
Proceeds from maturities of marketable securities	290,469	232,602
Net cash used in investing activities	(2,493)	(227,891)
Cash flows from financing activities:
Proceeds from issuances of common stock from equity plans	26,696	9,492
Proceeds from issuance of common stock from public offering and pre-funded warrant, net of paid issuance costs	140,729	213,337
Proceeds from exercise of warrants	418	105,912
Proceeds from employee stock purchase plan	366
Net cash provided by financing activities	168,209	328,741
Effect of exchange rates on cash, cash equivalents and restricted cash	17	(9)
Net increase in cash, cash equivalents and restricted cash	(8,940)	(25,964)
Cash, cash equivalents and restricted cash at the beginning of the period	71,138	57,209
Cash, cash equivalents and restricted cash at the end of the period	$ 62,198	$ 31,245

FAIR VALUE MEASUREMENTS - RECURRING BASIS (Details) - Recurring basis - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Fair Value on a Recurring Basis
Total	$ 355,420	$ 324,904
Money market funds
Fair Value on a Recurring Basis
Total	33,435	17,658
Certificate of deposit
Fair Value on a Recurring Basis
Total	273	272
U.S. Treasury securities
Fair Value on a Recurring Basis
Total	35,536	29,742
Government-sponsored enterprise securities
Fair Value on a Recurring Basis
Total	24,707	99,872
Commercial paper
Fair Value on a Recurring Basis
Total	141,015	102,268
Corporate notes
Fair Value on a Recurring Basis
Total	120,454	75,092
Level 1
Fair Value on a Recurring Basis
Total	33,708	17,930
Level 1 \| Money market funds
Fair Value on a Recurring Basis
Total	33,435	17,658
Level 1 \| Certificate of deposit
Fair Value on a Recurring Basis
Total	273	272
Level 2
Fair Value on a Recurring Basis
Total	321,712	306,974
Level 2 \| U.S. Treasury securities
Fair Value on a Recurring Basis
Total	35,536	29,742
Level 2 \| Government-sponsored enterprise securities
Fair Value on a Recurring Basis
Total	24,707	99,872
Level 2 \| Commercial paper
Fair Value on a Recurring Basis
Total	141,015	102,268
Level 2 \| Corporate notes
Fair Value on a Recurring Basis
Total	$ 120,454	$ 75,092

INVENTORY - Schedule of Inventory (Details) $ in Thousands	Sep. 30, 2024 USD ($)
Inventory Disclosure [Abstract]
Raw materials	$ 5,871
Work-in-process	13,544
Finished goods	868
Total inventory	$ 20,283

CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Current assets:
Cash and cash equivalents	$ 60,344	$ 70,023
Restricted cash	1,854	1,115
Marketable securities	279,430	263,676
Accounts receivable, net	28,007
Interest and other receivables	2,082	1,655
Inventory	20,283
Prepaid and other current assets	6,057	4,879
Total current assets	398,057	341,348
Noncurrent marketable securities	37,312	43,298
Property and equipment, net	1,595	1,177
Operating leases, right-of-use assets	3,055	3,556
Deposits and other assets	4,931	4,697
Total assets	444,950	394,076
Current liabilities:
Accounts payable	13,734	6,161
Accrued compensation and benefits	15,180	13,759
Operating lease liabilities	968	949
Debt	71,562	46,893
Accrued liabilities	36,489	40,308
Total current liabilities	137,933	108,070
Noncurrent operating lease liabilities	2,458	3,006
Noncurrent debt	12,275	35,051
Commitments and contingencies
Stockholders' equity:
Common stock	603	545
Additional paid-in capital	2,037,653	1,844,988
Accumulated deficit	(1,746,989)	(1,597,769)
Accumulated other comprehensive loss	1,017	185
Total stockholders' equity	292,284	247,949
Total liabilities and stockholders' equity	$ 444,950	$ 394,076

SUBSEQUENT EVENTS - Additional Information (Details) - USD ($)		9 Months Ended
	Nov. 01, 2024	Sep. 30, 2024
Royalty Pharma Revenue Participation Right Purchase Agreement
Subsequent Event [Line Items]
Revenue interest payments description		The Revenue Interest Payments to Royalty Pharma are capped, such that they will cease upon reaching a multiple of 1.65 times the Purchase Price if Royalty Pharma receives Revenue Interest Payments in that amount in respect of net sales occurring on or before June 30, 2031, or upon reaching a multiple of 2.0 times the Purchase Price thereafter. Our revenue payment obligations under the Royalty Pharma Agreement may be discharged in connection with a change of control of the Company in an amount equal to 1.65 times the Purchase Price minus the aggregate Revenue Interest Payments received by Royalty Pharma as of the date of the closing of the change of control, if the closing of the change of control occurs on or prior to December 31, 2027, or in an amount equal to 2.0 times the Purchase Price minus the aggregate Revenue Interest Payments received by Royalty Pharma as of the date of the closing of the change of control, if the closing of the change of control occurs after December 31, 2027.
Accrued Royalties		$ 0
Subsequent Event \| Pharmakon Loan Agreement \| Tranche A
Subsequent Event [Line Items]
Maximum borrowing capacity under term loan	$ 125,000,000
Effective interest rate	10.32%
Subsequent Event \| Pharmakon Loan Agreement \| Tranche B
Subsequent Event [Line Items]
Maximum borrowing capacity under term loan	$ 75,000,000
Subsequent Event \| Pharmakon Loan Agreement \| Tranche C
Subsequent Event [Line Items]
Maximum borrowing capacity under term loan	$ 50,000,000
Subsequent Event \| Pharmakon Loan Agreement \| Term Loans
Subsequent Event [Line Items]
Term loan maturity date	Nov. 01, 2029
Spread on variable rate	5.75%
Debt Instrument, Variable Interest Rate, Type [Extensible Enumeration]	Secured Overnight Financing Rate (SOFR) [Member]
Floor rate	3.00%
Percentage of commitment amount to fund loan	2.50%
Subsequent Event \| Pharmakon Loan Agreement \| 3rd Anniversary Of Funding Date \| Term Loans
Subsequent Event [Line Items]
Prepayment premium on percentage of term loan	3.00%
Subsequent Event \| Pharmakon Loan Agreement \| 3rd Anniversary But, Prior To 4th Anniversary Of Funding Date \| Term Loans
Subsequent Event [Line Items]
Prepayment premium on percentage of term loan	2.00%
Subsequent Event \| Pharmakon Loan Agreement \| 4th Anniversary Of Funding Date \| Term Loans
Subsequent Event [Line Items]
Prepayment premium on percentage of term loan	1.00%
Subsequent Event \| Pharmakon Loan Agreement \| BioPharma Credit PLC
Subsequent Event [Line Items]
Maximum borrowing capacity under term loan	$ 250,000,000
Line of credit, maturity period	5 years
Subsequent Event \| Royalty Pharma Revenue Participation Right Purchase Agreement
Subsequent Event [Line Items]
Upfront payment received	$ 125,000,000
Subsequent Event \| Royalty Pharma Revenue Participation Right Purchase Agreement \| Scenario One
Subsequent Event [Line Items]
Percentage of annual net sales	7.75%
Subsequent Event \| Royalty Pharma Revenue Participation Right Purchase Agreement \| Scenario One \| Maximum
Subsequent Event [Line Items]
Revenue interest payments	$ 500,000,000
Subsequent Event \| Royalty Pharma Revenue Participation Right Purchase Agreement \| Scenario Two
Subsequent Event [Line Items]
Percentage of annual net sales	3.00%
Subsequent Event \| Royalty Pharma Revenue Participation Right Purchase Agreement \| Scenario Two \| Maximum
Subsequent Event [Line Items]
Revenue interest payments	$ 1,000,000,000
Subsequent Event \| Royalty Pharma Revenue Participation Right Purchase Agreement \| Scenario Two \| Minimum
Subsequent Event [Line Items]
Revenue interest payments	$ 500,000,000
Subsequent Event \| Royalty Pharma Revenue Participation Right Purchase Agreement \| Scenario Three
Subsequent Event [Line Items]
Percentage of annual net sales	1.00%
Subsequent Event \| Royalty Pharma Revenue Participation Right Purchase Agreement \| Scenario Three \| Minimum
Subsequent Event [Line Items]
Revenue interest payments	$ 1,000,000,000
Subsequent Event \| Hercules Loan Agreement \| Tranche A
Subsequent Event [Line Items]
Repayment of line of credit	$ 86,500,000
Term loan maturity date	Nov. 01, 2024

DEBT - Additional Information (Details) - USD ($)		9 Months Ended
DEBT - Additional Information (Details) - USD ($)	Jun. 30, 2022	Sep. 30, 2024	Sep. 30, 2020	Oct. 01, 2024	Sep. 15, 2023
Debt Instrument [Line Items]
Principal amount outstanding under term loan		$ 92,503,000
Hercules and Silicon Valley Bank [Member]
Debt Instrument [Line Items]
Maximum borrowing capacity under term loan	$ 125,000,000		$ 75,000,000
Principal amount outstanding under term loan		80,000,000
Carrying value of term loan, net		83,800,000
Unamortized debt discount and issuance costs		258,000
Accrued end of term charge		$ 100,000
Percentage added to prime rate for debt instrument interest rate			9.00%
Description of maturity date terms for term loan			matures on October 1, 2025, or the Loan Maturity Date, which was extended from April 1, 2025 upon regulatory approval of RYTELO.
Term loan maturity date			Oct. 01, 2025
Term loan interest rate description		The Hercules Loan Agreement bears interest at a floating rate per annum equal to the greater of either (i) 9.0% or (ii) the sum of (A) the Prime Rate (as reported in The Wall Street Journal) minus 4.5%, plus (B) 9.0% (12.5% as of September 30, 2024).
Interest only period payment term description			The interest only period of the Hercules Loan Agreement was extended from June 30, 2024 through December 31, 2024. due to regulatory approval of RYTELO and satisfaction of certain financial and capitalization requirements. Following the expiration of the interest-only period, we are required to repay the Hercules Loan Agreement in equal monthly amortization payments of principal and interest until the Loan Maturity Date.
End of term charge for loan, percentage			6.55%
Minimum amount of prepayment allowed under debt instrument			$ 5,000,000
Description of term loan payment terms			At our option, upon at least seven business days’ prior written notice to Hercules, we are able to prepay all or any portion greater than or equal to $5.0 million of the outstanding loan by paying the entire principal balance (or portion thereof) and all accrued and unpaid interest. There was no prepayment charge for prepayments of drawdowns under Tranche 1 or Tranche 2. Prepayments of drawdowns under Tranche 3, Tranche 4, Tranche 5 or Tranche 6 are subject to a prepayment charge of 1.5% of the prepayment amount, if the prepayment is made prior to June 30, 2025. Thereafter, any prepayment of Tranche 3, Tranche 4, Tranche 5 or Tranche 6 is not subject to a prepayment charge.
Hercules and Silicon Valley Bank [Member] \| Second Amendment [Member]
Debt Instrument [Line Items]
Debt discount amount	$ 100,000
Hercules and Silicon Valley Bank [Member] \| Third Amendment [Member]
Debt Instrument [Line Items]
Principal amount outstanding under term loan		$ 80,000,000
Debt discount amount		300,000
Principle amount		$ 125,000,000
Percentage added to prime rate for debt instrument interest rate		9.00%
Hercules and Silicon Valley Bank [Member] \| Minimum [Member]
Debt Instrument [Line Items]
Stated interest rate			4.50%
Hercules and Silicon Valley Bank [Member] \| Minimum [Member] \| Third Amendment [Member]
Debt Instrument [Line Items]
Stated interest rate		4.50%
Hercules and Silicon Valley Bank [Member] \| Maximum [Member]
Debt Instrument [Line Items]
Stated interest rate		12.50%	9.00%
Hercules and Silicon Valley Bank [Member] \| Maximum [Member] \| Third Amendment [Member]
Debt Instrument [Line Items]
Stated interest rate		9.00%
Hercules and Silicon Valley Bank [Member] \| Tranche One [Member] \| Third Amendment [Member]
Debt Instrument [Line Items]
Prepayment charge (as a percentage)	0.00%
Hercules and Silicon Valley Bank [Member] \| Tranche Two [Member] \| Third Amendment [Member]
Debt Instrument [Line Items]
Prepayment charge (as a percentage)	0.00%
Hercules and Silicon Valley Bank [Member] \| Tranche Three [Member] \| Third Amendment [Member]
Debt Instrument [Line Items]
Prepayment charge (as a percentage)	1.50%
Debt instrument face amount expired					$ 20,000,000
Hercules and Silicon Valley Bank [Member] \| Tranche Four [Member] \| Third Amendment [Member]
Debt Instrument [Line Items]
Prepayment charge (as a percentage)	1.50%
Principle amount		$ 30,000,000
Hercules and Silicon Valley Bank [Member] \| Tranche Four [Member] \| Minimum [Member] \| Third Amendment [Member]
Debt Instrument [Line Items]
Principle amount		10,000,000
Hercules and Silicon Valley Bank [Member] \| Tranche Four [Member] \| Maximum [Member] \| Third Amendment [Member]
Debt Instrument [Line Items]
Principle amount		30,000,000
Hercules and Silicon Valley Bank [Member] \| Tranche Five [Member] \| Third Amendment [Member]
Debt Instrument [Line Items]
Prepayment charge (as a percentage)	1.50%
Principle amount		$ 20,000,000
Hercules and Silicon Valley Bank [Member] \| Tranche Six [Member] \| Third Amendment [Member]
Debt Instrument [Line Items]
Prepayment charge (as a percentage)	1.50%
BioPharma Credit PLC [Member] \| Subsequent Event [Member]
Debt Instrument [Line Items]
Maximum borrowing capacity under term loan				$ 86,500,000

FAIR VALUE MEASUREMENTS

9 Months Ended

Sep. 30, 2024

Fair Value Disclosures [Abstract]

FAIR VALUE MEASUREMENTS

4. FAIR VALUE MEASUREMENTS

Cash Equivalents and Marketable Securities

Cash equivalents, restricted cash and marketable securities by security type at September 30, 2024 were as follows:


			Gross		Gross
	Amortized		Unrealized		Unrealized			Estimated
(In thousands)	Cost		Gains		Losses			Fair Value
Included in cash and cash equivalents:
Money market funds	$	31,854	$	—	$	—		$	31,854
Commercial paper		4,970		2		—		$	4,972
	$	36,824	$	2	$	—		$	36,826

Restricted cash:
Money market fund	$	1,581	$	—	$	—		$	1,581
Certificate of deposit		273		—		—			273
	$	1,854	$	—	$	—		$	1,854

Marketable securities:
U.S. Treasury securities (due in less than one year)	$	35,481	$	56	$	—		$	35,537
Government-sponsored enterprise securities (due in less than one year)		19,680		27		—			19,707
Government-sponsored enterprise securities (due in one to two years)		5,000		—		—			5,000
Commercial paper (due in less than one year)		135,717		327		(1	)		136,043
Corporate notes (due in less than one year)		87,816		327		(2	)		88,141
Corporate notes (due in one to two years)		32,042		273		(1	)		32,314
	$	315,736	$	1,010	$	(4	)	$	316,742

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


			Gross		Gross
	Amortized		Unrealized		Unrealized			Estimated
(In thousands)	Cost		Gains		Losses			Fair Value
Included in cash and cash equivalents:
Money market funds	$	16,815	$	—	$	—		$	16,815
	$	16,815	$	—	$	—		$	16,815

Restricted cash:
Money market fund	$	843	$	—	$	—		$	843
Certificate of deposit		272		—		—			272
	$	1,115	$	—	$	—		$	1,115

Marketable securities:
U.S. Treasury securities (due in less than one year)	$	26,752	$	95	$	—		$	26,847
U.S. Treasury securities (due in one to two years)		2,877		17		—			2,894
Government-sponsored enterprise securities (due in less than one year)		86,250		43		(92	)		86,201
Government-sponsored enterprise securities (due in one to two years)		13,598		72		—			13,670
Commercial paper (due in less than one year)		102,270		31		(33	)		102,268
Corporate notes (due in less than one year)		48,409		14		(63	)		48,360
Corporate notes (due in one to two years)		26,628		130		(24	)		26,734
	$	306,784	$	402	$	(212	)	$	306,974


	Less Than 12 Months					12 Months or Longer					Total
			Gross					Gross					Gross
	Estimated		Unrealized			Estimated		Unrealized			Estimated		Unrealized
(In thousands)	Fair Value		Losses			Fair Value		Losses			Fair Value		Losses
As of September 30, 2024:
Commercial paper (due in less than one year)	$	10,929	$	—		$	—	$	—		$	10,929	$	—
Corporate notes (due in less than one year)		—		—			1,986		(2	)		1,986		(2	)
Corporate notes (due in one to two years)		1,913		(2	)		—		—			1,913		(2	)
	$	12,842	$	(2	)	$	1,986	$	(2	)	$	14,828	$	(4	)

As of December 31, 2023:
Government-sponsored enterprise securities (due in less than one year)	$	69,377	$	(92	)	$	—	$	—		$	69,377		(92	)
Commercial paper (due in less than one year)		58,622		(33	)		—		—			58,622		(33	)
Corporate notes (due in less than one year)		34,567		(63	)		—		—			34,567		(63	)
Corporate notes (due in one to two years)		3,952		(23	)		—		—			3,952		(23	)
	$	166,518	$	(211	)	$	—	$	—		$	166,518	$	(211	)

The gross unrealized losses related to U.S. Treasury securities, municipal securities, government-sponsored enterprise securities, commercial paper and corporate notes as of September 30, 2024 and December 31, 2023 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 nine months ended September 30, 2024 and 2023 as we have not identified any unrealized losses for these securities attributable to credit factors. Our exposure to unrealized losses may increase in the future due to the economic pressures or uncertainties associated with macroeconomic or other global economic conditions, including those resulting from inflation, rising interest rates, prospects of a recession, bank failures and other disruptions to financial systems, civil or political unrest, military conflicts, pandemics or other health crises.

Fair Value on a Recurring Basis

We categorize financial instruments recorded at fair value on our condensed consolidated balance sheets based upon the level of judgment associated with inputs used to measure their fair value. The categories are as follows:


Level 1	—	Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date. An active market for an asset or liability is a market in which transactions for the asset or liability occur with sufficient frequency and volume to provide pricing information on an ongoing basis.
Level 2	—	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.
Level 3	—	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. Money market funds are categorized as Level 1 within the fair value hierarchy as their fair values are based on quoted prices available in active markets. U.S. 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.


	Fair Value Measurements at Reporting Date Using
	Quoted Prices in				Significant
	Active Markets for		Significant Other		Unobservable
	Identical Assets		Observable Inputs		Inputs
(In thousands)	Level 1		Level 2		Level 3		Total
As of September 30, 2024:
Money market funds(1)(2)	$	33,435	$	—	$	—	$	33,435
Certificate of deposit(2)		273		—		—		273
U.S. Treasury securities(3)		—		35,536		—		35,536
Government-sponsored enterprise securities(3)(4)		—		24,707		—		24,707
Commercial paper(3)		—		141,015		—		141,015
Corporate notes(3)(4)		—		120,454		—		120,454
Total	$	33,708	$	321,712	$	—	$	355,420
As of December 31, 2023:
Money market funds(1)(2)	$	17,658	$	—	$	—	$	17,658
Certificate of deposit(2)		272		—		—		272
U.S. Treasury securities(3)(4)		—		29,742		—		29,742
Government-sponsored enterprise securities(3)(4)		—		99,872		—		99,872
Commercial paper(3)		—		102,268		—		102,268
Corporate notes(3)(4)		—		75,092		—		75,092
Total	$	17,930	$	306,974	$	—	$	324,904

(1)

Included in cash and cash equivalents on our condensed consolidated balance sheets.

(2)

Included in restricted cash on our condensed consolidated balance sheets.

(3)

Included in current portion of marketable securities on our condensed consolidated balance sheets.

(4)

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

- Definition

The entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.

+ References

Reference 1: http://www.xbrl.org/2003/role/exampleRef
-Topic 820
-SubTopic 10
-Name Accounting Standards Codification
-Section 55
-Paragraph 107
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482078/820-10-55-107

Reference 2: http://www.xbrl.org/2003/role/exampleRef
-Topic 820
-SubTopic 10
-Name Accounting Standards Codification
-Section 55
-Paragraph 100
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482078/820-10-55-100

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 820
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (c)(3)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482106/820-10-50-2

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 820
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-Name Accounting Standards Codification
-Section 50
-Paragraph 6A
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482106/820-10-50-6A

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Topic 820
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 2E
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482106/820-10-50-2E

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 820
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 6A
-Subparagraph (h)
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-URI https://asc.fasb.org/1943274/2147482106/820-10-50-6A

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 820
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-Name Accounting Standards Codification
-Section 50
-Paragraph 6A
-Subparagraph (f)
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-URI https://asc.fasb.org/1943274/2147482106/820-10-50-6A

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 820
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-Name Accounting Standards Codification
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-Paragraph 6A
-Subparagraph (e)
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-URI https://asc.fasb.org/1943274/2147482106/820-10-50-6A

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 820
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-Name Accounting Standards Codification
-Section 50
-Paragraph 6A
-Subparagraph (d)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482106/820-10-50-6A

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Topic 820
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-Name Accounting Standards Codification
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-Paragraph 2
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-Publisher FASB
-URI https://asc.fasb.org/1943274/2147482106/820-10-50-2

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
-Topic 820
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-URI https://asc.fasb.org/1943274/2147482106/820-10-50-2

Reference 12: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
-Section 50
-Paragraph 1
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147478119/940-820-50-1

+ Details

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - NET LOSS PER SHARE (Details) - Pre-Funded Warrants	Sep. 30, 2024 $ / shares shares
Warrant exercise price	$ 0.001
Public Offering of Common Stock and Warrants
Warrant to purchase common stock, shares \| shares	59,433,145
Warrant exercise price	$ 0.001

DEBT - Future Minimum Payments Under Loan Agreement (Details) - USD ($) $ in Thousands	Sep. 30, 2024	Dec. 31, 2023
Debt Disclosure [Abstract]
Remainder of 2024	$ 2,548
2025	89,955
Total	92,503
Less: amount representing interest	(7,263)
Less: unamortized debt discounts and issuance costs	(258)
Less: unaccrued end of term charge	(1,145)
Less: current portion of debt	(71,562)
Noncurrent portion of debt	$ 12,275	$ 35,051

- Definition

Amount of unamortized debt discount (premium) and debt issuance costs.

+ References + Details

CONTINGENCIES AND UNCERTAINTIES - Severance Plan (Details) $ in Millions	9 Months Ended
	Sep. 30, 2024 USD ($) Plan
Severance Plan
Severance plans	2
Period within which employee is terminated by entity without cause following a change of control	12 months
Period within which no comparable employment is offered by the entity following a change of control	30 days
Period within which employee resigns following a change of control due to material change in terms of employment	12 months
Noncancelable commercial purchase commitments \| $	$ 62.4
Employees Above The Vice President Level
Severance Plan
Severance plans	1
Minimum
Severance Plan
Period of base salary to be considered for severance payments	3 months
Period of base salary in connection with a non-change of control to be considered for severance payments	42 days
Maximum
Severance Plan
Period of base salary to be considered for severance payments	18 months
Period of base salary in connection with a non-change of control to be considered for severance payments	12 months

Pay vs Performance Disclosure - USD ($) $ in Thousands	3 Months Ended						9 Months Ended
Pay vs Performance Disclosure - USD ($) $ in Thousands	Sep. 30, 2024	Jun. 30, 2024	Mar. 31, 2024	Sep. 30, 2023	Jun. 30, 2023	Mar. 31, 2023	Sep. 30, 2024	Sep. 30, 2023
Pay vs Performance Disclosure
Net Income (Loss)	$ (26,447)	$ (67,383)	$ (55,390)	$ (44,805)	$ (49,227)	$ (38,122)	$ (149,220)	$ (132,154)

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

+ References

+ Details

DEBT (Tables)

9 Months Ended

Sep. 30, 2024

Debt Disclosure [Abstract]

Future Minimum Payments Under Loan Agreement

The following table presents future minimum payments, including interest and the end of term charge, under the Loan Agreement as of September 30, 2024 (in thousands):


Remainder of 2024	$	2,548
2025		89,955
Total		92,503
Less: amount representing interest		(7,263	)
Less: unamortized debt discount and issuance costs		(258	)
Less: unaccrued end of term charge		(1,145	)
Less: current portion of debt		(71,562	)
Noncurrent portion of debt	$	12,275

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)

9 Months Ended

Sep. 30, 2024

Accounting Policies [Abstract]

Basis of Presentation

The terms “Geron”, the “Company”, “we” and “us” as used in this Report refer to Geron Corporation and its wholly-owned subsidiaries, Geron UK Limited, or Geron UK, a United Kingdom company, and Geron Netherlands B.V., or Geron Netherlands, a Netherlands company. Geron UK was incorporated in September 2021, and its operations commenced in January 2022. Geron Netherlands was incorporated in February 2023, and its operations commenced in June 2023.

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by United States, or U.S., generally accepted accounting principles, or GAAP, for complete financial statements. 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 nine months ended September 30, 2024 are not necessarily indicative of the results that may be expected for the year ending December 31, 2024 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, 2023, included in our Annual Report on Form 10-K for the year ended December 31, 2023, or the 2023 Form 10-K. The accompanying condensed consolidated balance sheet as of December 31, 2023 has been derived from audited financial statements at that date.

Principles of Consolidation

The condensed consolidated financial statements include the accounts of Geron Corporation and its wholly-owned subsidiaries, Geron UK and Geron Netherlands. For Geron UK and Geron Netherlands, we have eliminated intercompany accounts and transactions. We prepare the financial statements of Geron UK and Geron Netherlands using the local currency as the functional currency. We translate the assets and liabilities of Geron UK and Geron Netherlands at rates of exchange at the balance sheet date and translate income and expense items at average monthly rates of exchange. The resultant translation adjustments are included in accumulated other comprehensive income (loss), a separate component of stockholders’ equity, on our condensed consolidated balance sheets.

Net Loss Per Share

Basic net income (loss) per share is calculated by dividing net income (loss) by the weighted-average number of shares of common stock outstanding for the periods presented without consideration of potential common shares. In 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 September 30, 2024, none of these pre-funded warrants have been exercised. These pre-funded warrants, which represent an aggregate of 59,433,145 shares of common stock, have been included in the computation of basic net loss per share, since their exercise price is negligible and they may be exercised at any time.

Diluted net income per share would be calculated by adjusting the weighted-average number of shares of common stock outstanding for the dilutive effect of additional shares of common stock that would have been outstanding if potentially dilutive securities had been issued, as determined using the treasury-stock method. Potential dilutive securities consist of outstanding stock options and warrants to purchase our common stock. Diluted net loss per share excludes potential dilutive securities for all periods presented as their effect would be anti-dilutive. 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 nine months ended September 30, 2024 and 2023, the diluted net loss per share calculation excludes potential dilutive securities of 76,588,779 and 77,651,673, respectively, related to outstanding stock options and warrants as their effect would have been anti-dilutive.

Use of Estimates

The accompanying condensed consolidated financial statements have been prepared in accordance with U.S. GAAP. The preparation of financial statements in conformity with U.S. GAAP requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. On an ongoing basis, we evaluate our estimates, including those related to accrued liabilities, revenue recognition, fair value of marketable securities, operating leases, right-of-use assets, lease liabilities, income taxes, and stock-based compensation. We base our estimates on historical experience and on various other market specific and relevant assumptions that we believe to be reasonable under the circumstances. Actual results could differ from those estimates.

Accounts Receivable

In general, accounts receivable consists of amounts due from customers, net of customer allowances for cash discounts, product returns, and chargebacks. Accounts receivable are stated net of an allowance that reflects our current estimate of credit losses expected to occur over the life of the receivable. In developing our allowance for expected credit losses, we use assumptions to capture the risk of loss, even if remote, based on a number of factors including existing contractual payment terms, individual customer circumstances, historical payment patterns of our customers, a review of the local economic environment and its potential impact on expected future customer payment patterns. The payment terms on our trade receivables are relatively short. As a result, our collection risk is mitigated to a certain extent by the fact that sales are collected in a relatively short period of time, allowing for the ability to reduce exposure on defaults if collection issues are identified. We update our allowance as necessary to reflect expected credit losses over the remaining lives of the accounts receivable for outstanding trade receivables that are past due, have known disputes or have experienced any negative credit events that may result in future collectability issues. We do not currently expect our current or future exposures to credit losses to have a significant impact on us. The estimated allowance for expected credit losses was not material as of September 30, 2024, nor were the changes to the allowance during any of the periods presented.

Inventory

Inventory is recorded at the lower of cost or net realized value, with cost determined under the weighted average method. Inventory costs include third-party contract manufacturing, third-party packaging services, freight, salaries, wages and stock-based compensation for personnel involved in the manufacturing process, and indirect overhead costs. We periodically review our inventories to identify obsolete, slow moving, excess or otherwise unsaleable items. If obsolete, slow moving, excess or unsaleable items are observed and there are no alternate uses for the inventory, we record a write-down to net realizable value. The determination of net realizable value requires judgment including consideration of many factors, such as estimates of future product demand, product net selling prices, current and future market conditions and potential product obsolescence, among others. Prior to regulatory approval, we expensed costs associated with the manufacture of a product candidate to research and development expense unless we are reasonably certain such costs have future commercial use and net realizable value. Since we consider attaining regulatory approval of a product candidate to be highly uncertain and difficult to predict, we expect only in rare instances that pre-launch inventory will be capitalized, if at all.

We began capitalizing inventory related to RYTELO in the quarter ended June 30, 2024, as we received approval of RYTELO on June 6, 2024, and the related costs were expected to be recoverable through the commercialization of RYTELO.

Cost of Goods Sold

Cost of goods sold includes the cost of producing and distributing inventories that are related to product revenue during the respective period, including salary related and stock-based compensation expense for employees involved with production and distribution, freight, and indirect overhead costs. Cost of goods sold may also include costs related to excess or obsolete inventory adjustment charges, abnormal costs, unabsorbed manufacturing and overhead costs, and manufacturing variances. For the three and nine months ended September 30, 2024, other than packaging costs, substantially all of our RYTELO inventory sold had a zero-cost basis as it was recorded as research and development expenses prior to the FDA’s approval.

Fair Value of Financial Instruments

Cash Equivalents and Marketable Securities

We consider all highly liquid investments with an original maturity of three months or less to be cash equivalents. We are subject to credit risk related to our cash equivalents and marketable securities. Our marketable debt securities include U.S. Treasury securities, government-sponsored enterprise securities, commercial paper and corporate notes.

We classify our marketable debt securities as available for sale. We record available-for-sale debt securities at fair value with unrealized gains and losses reported in accumulated other comprehensive income (loss) in stockholders’ equity. Realized gains and losses are included in interest income and are derived using the specific identification method for determining the cost of securities sold and have been insignificant to date. Dividend and interest income are recognized when earned and included in interest income on our condensed consolidated statements of operations. See Note 4 on Fair Value Measurements.

Leases

At the inception of an arrangement, we determine whether the arrangement is or contains a lease based on the unique facts and circumstances present. Operating leases are included in operating leases, right-of-use assets and lease liabilities on our condensed consolidated balance sheets. Right-of-use assets represent our right to use an underlying asset for the lease term and lease liabilities

represent our obligation to make lease payments arising from the lease. Operating lease liabilities and their corresponding right-of-use assets are recorded based on the present value of remaining lease payments over the expected lease term. The present value of remaining lease payments within the 12 months following the balance sheet date are classified as current lease liabilities. The present value of lease payments not within the 12 months following the balance sheet date are classified as noncurrent lease liabilities. The interest rate implicit in lease contracts is typically not readily determinable. As such, to calculate the net present value of lease payments, we apply our incremental borrowing rate, which is the estimated rate to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment as of the lease commencement date. We may adjust the right-of-use assets for certain adjustments, such as initial direct costs paid or incentives received. In addition, we include any options to extend or terminate the lease in the expected lease term when it is reasonably certain that we will exercise any such option. Lease expense is recognized on a straight-line basis over the expected lease term.

For lease agreements entered into after January 1, 2019 that include lease and non-lease components, such components are generally accounted for separately. We have also elected not to recognize on our condensed consolidated balance sheets leases with terms of one year or less.

Debt Issuance Costs and Debt Discounts

Debt issuance costs include legal fees, accounting fees, and other direct costs incurred in connection with the execution of our debt financing. Debt discounts represent costs paid to the lenders. Debt issuance costs and debt discounts are deducted from the carrying amount of the debt liability and are amortized to interest expense over the term of the related debt using the effective interest method.

Revenue Recognition

We recognize revenue in accordance with the provisions of Accounting Standards Codification Topic 606, Revenue from Contracts with Customers, or Topic 606. In determining the appropriate amount and timing of revenue to be recognized under this guidance, we perform the following five steps: (i) identify the contract(s) with our customer; (ii) identify the promised goods or services in the agreement and determine whether they are performance obligations, based on whether they are capable of being distinct and distinct in the context of the agreement; (iii) determine the transaction price, including the constraint on variable consideration; (iv) allocate the transaction price to the performance obligations based on stand-alone selling prices; and (v) recognize revenue when (or as) we satisfy each performance obligation. We recognize shipping and handling costs as an expense in cost of goods sold when we transfer control to a customer.

A performance obligation is a promise in an agreement to transfer a distinct good or service to the customer and is the unit of account in Topic 606. Significant management judgment is required to determine the level of effort required and the period over which completion of the performance obligations is expected under an agreement. If reasonable estimates regarding when performance obligations are either complete or substantially complete cannot be made, then revenue recognition is deferred until a reasonable estimate can be made. Revenue is then recognized over the remaining estimated period of performance using the cumulative catch-up method.

We allocate the total transaction price to each performance obligation based on the estimated relative stand-alone selling prices of the promised goods or services underlying each performance obligation. Estimated selling prices for license rights are calculated using an income approach model and include the following key assumptions, judgments and estimates: the development timeline, revenue forecast, commercialization expenses, discount rate and probabilities of technical and regulatory success.

We distribute RYTELO in the U.S. through third party distributors and specialty pharmacies who are our customers. The third party distributors subsequently resell our product through their related specialty pharmacy providers to patients and health care providers. Separately, we have or may enter into payment arrangements with various third-party payers including pharmacy benefit managers, private healthcare insurers and government healthcare programs who provide coverage and reimbursement for our product that have been prescribed to a patient.

The following is a description of the principal activities from which we generate revenue. License fees and royalty revenue primarily represent amounts earned under agreements that out-license our technology to various companies. To date, our only source of product revenue has been from the U.S. sales of RYTELO, which we began shipping to our customers in June 2024. See Note 2 Revenue Recognition.

Net Product Revenues

Our net product revenues are recognized, net of variable consideration related to certain allowances and accruals, at the time our customers obtain control of our product, which is generally upon delivery to our customers. We use the expected value method, which

is the sum of probability-weighted amounts in a range of possible consideration amounts to estimate variable consideration and consideration payable to parties other than our customers related to our product sales.

We record reserves, based on contractual terms, for components related to product sold during the reporting period, as well as our estimate of product that remains in the distribution channel inventory at the end of the reporting period that we expect will be sold to qualified healthcare providers. On a quarterly basis, we update our estimates and record any needed adjustments in the period we identify the adjustments.

We sell RYTELO to our customers at wholesale acquisition cost, and calculate product revenue from RYTELO sales, net of variable consideration and consideration payable to parties other than our customers. Variable consideration and consideration payable to parties other than our customers consists of estimates related to the following categories:

Other Allowances

We pay fees for distribution services, such as fees for certain data that customers provide to us. We estimate our customers will earn these fees and deduct these fees from gross product revenues and accounts receivable at the time we recognize the related revenues.

Discounts for Prompt Payment

We provide for prompt payment discounts to our customers, which are recorded as a reduction in gross product revenue in the same period that the related product revenue is recognized.

Product Returns

We offer customers the right to return products if they are damaged, defective, or expired, as defined in customer agreements. We estimate product returns considering experience from similar products in the market, historical return patterns, sales data, and inventory levels in the distribution channel. These estimates are recorded as a reduction in gross product revenue at the time of sale. Once products are returned, they are destroyed; we do not record a right of return asset.

Chargebacks

Chargebacks occur when our contracted customers, mainly federal agencies that can purchase off the Federal Supply Schedule and Public Health Service 340B covered entities, buy directly from our distributors and wholesalers at discounted prices. The distributors and wholesalers then charge us the difference between their purchase price and the discounted price. We estimate chargebacks considering the terms of the applicable arrangement and our visibility regarding utilization. These chargebacks are recorded in the same period as the related revenue, reducing our net product revenue and receivables. We typically issue credits for these amounts within a few weeks of notification.

Government Rebates

We are subject to discount obligations under government programs. Reserves for rebates payable under these government programs are recorded in the same period as gross product revenue, reducing our gross product revenue and creating a liability in accrued liabilities. Major rebates include those from the Medicare and Medicaid programs. Estimates for rebates are made considering statutory discount rates and expected utilization. These estimates are updated each period with actual claims and other current information, taking into account historical data, comparable products and other considerations.

Co-payment Assistance

We offer co-payment assistance to patients with commercial insurance that have coverage and reside in states that allow co-payment assistance. We estimate the average co-payment assistance amounts for our products based on expected customer demographics and record any such amounts within accrued expenses and a reduction to product revenue.

License Agreements

In connection with the divestiture of Geron’s human embryonic stem cell assets, including intellectual property and proprietary technology, to Lineage Cell Therapeutics, Inc. (formerly BioTime, Inc. which acquired Asterias Biotherapeutics, Inc.) in 2013, we are entitled to receive royalties on sales of certain research or commercial products utilizing Geron’s divested intellectual property.

Royalties

For agreements with sales-based royalties, including milestone payments based on the level of sales, where the license is deemed to be the predominant item to which the royalties relate, we recognize revenue at the later of (a) when the related sales occur, or (b) when the performance obligation, to which some or all of the royalty has been allocated, has been satisfied (or partially satisfied). At each reporting date, we estimate the sales incurred by each licensee during the reporting period based on historical experience and accrue the associated royalty amount.

Restricted Cash

Restricted cash consists of funds maintained in separate money market or certificate of deposit accounts for credit card purchases.

Research and Development Expenses

Research and development expenses currently consist of expenses incurred in developing and testing imetelstat and research related to potential next generation telomerase inhibitors. These expenses include, but are not limited to, payroll and personnel expense, lab supplies, non-clinical studies, clinical trials, including support for investigator-led clinical trials, raw materials to manufacture clinical trial drugs, manufacturing costs for research and clinical trial materials, sponsored research at other labs, consulting, costs to maintain technology licenses and research-related overhead.

Our current imetelstat clinical trials are being supported by contract research organizations, or CROs, and other vendors. We accrue expenses for clinical trial activities performed and managed by CROs based upon the amount of work completed on each trial. Expenses are recorded based on contracted amounts agreed to with our CROs and through monthly reporting provided by CROs. We monitor activities conducted and managed by the CROs to the extent possible through internal reviews, review of contractual terms and correspondence with CROs. We record expense on the best information available at the time. However, additional information may become available to us which may require adjustments to research and development expenses in future periods.

Depreciation and Amortization

We record property and equipment at cost and calculate depreciation using the straight-line method over the estimated useful lives of the assets, generally four years. Leasehold improvements are amortized over the shorter of the estimated useful life or remaining term of the lease.

Stock-Based Compensation

We maintain various stock incentive plans under which stock options and restricted stock awards can be granted to employees, non-employee directors and consultants. We also have an employee stock purchase plan for all eligible employees. We recognize stock-based compensation expense based on grant-date fair values of service-based stock options on a straight-line basis over the requisite service period, which is generally the vesting period. For performance-based stock options with vesting based on the achievement of certain strategic milestones, stock-based compensation expense is recognized over the period from the date the performance condition is determined to be probable of occurring through the date the applicable condition is expected to be met and is reduced for estimated forfeitures, as applicable. If the performance condition is not considered probable of being achieved, no stock-based compensation expense is recognized until such time as the performance condition is considered probable of being met, if at all. If the assessment of probability of the performance condition changes, the impact of the change in estimate would be recognized in the period of the change. The determination of grant-date fair values for our service-based and performance-based stock options and employee stock purchases using the Black-Scholes option‑pricing model is affected by our stock price as well as assumptions regarding a number of complex and subjective variables. The grant-date fair value for service-based restricted stock awards is determined using the fair value of our common stock on the date of grant. 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.


	Three Months Ended September 30,				Nine Months Ended September 30,
(In thousands)	2024		2023		2024		2023
Research and development	$	1,904	$	2,951	$	7,960	$	5,847
Selling, general and administrative		4,986		4,253		16,432		8,263
Total stock-based compensation expense	$	6,890	$	7,204	$	24,392	$	14,110

Stock-based compensation of $0.3 million and $0.4 million was capitalized to inventory for the three and nine months ended September 30, 2024, respectively.

As stock-based compensation expense recognized in our condensed consolidated statements of operations for the three and nine months ended September 30, 2024 and 2023 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 recognized stock-based compensation expense for the achievement of a milestone achieved upon FDA approval of RYTELO on our condensed consolidated statements of operations for the three and nine months ended September 30, 2024 and 2023.

Stock Options

We grant service-based and performance-based stock options under our equity plans to employees, non-employee directors and consultants. The service-based vesting period for employee stock options is generally four years from the date of the stock option grant. Performance-based stock options vest upon the achievement of specified strategic milestones. The fair value of service-based stock options granted during the nine months ended September 30, 2024 and 2023 has been estimated at the date of grant using the Black- Scholes option-pricing model with the following assumptions:


	Nine Months Ended September 30,
	2024	2023
Dividend yield	0%	0%
Expected volatility range	82.94% to 86.68%	81.53% to 82.12%
Risk-free interest rate range	3.53% to 4.62%	3.42% to 4.62%
Expected term	6 years	6 years

Employee Stock Purchase Plan


	Nine Months Ended September 30,
	2024	2023
Dividend yield	0%	0%
Expected volatility range	72.08% to 119%	79.05% to 83.22%
Risk-free interest rate range	4.79% to 5.37%	4.73% to 5.40%
Expected term range	6 months to 12 months	6 months to 12 months

Dividend yield is based on historical cash dividend payments and Geron has paid no cash dividends to date. The expected volatility range is based on historical volatilities of our stock, since traded options on Geron common stock do not correspond to option terms and the trading volume of options is limited. The risk-free interest rate range is based on the U.S. Zero Coupon Treasury Strip Yields for the expected term in effect on the date of grant for an award. The expected term of stock options is derived from actual historical exercise and post-vesting cancellation data and represents the period of time that stock options granted are expected to be outstanding. The expected term of employees’ stock purchase rights is equal to the purchase period.

Non-Employee Stock-Based Awards

We measure share-based payments to non-employees based on the grant-date fair value of the equity awards. We recognize stock-based compensation expense for the fair value of the vested portion of non-employee stock-based awards on our condensed consolidated statements of operations.

Segment Information

Our executive management team represents our chief decision maker. We view our operations as a single segment, the development and commercialization of therapeutic products for oncology. As a result, the financial information disclosed herein materially represents all of the financial information related to our principal operating segment.

Recent Accounting Pronouncements

New Accounting Pronouncements – Recently Adopted

In August 2020, the FASB issued ASU 2020-06, Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity, or ASU 2020-06. The key elements of ASU 2020-06 aim to reduce unnecessary complexity in GAAP for certain financial instruments with characteristics of liabilities and equity. In addressing the complexity, the FASB focused on amending the guidance on convertible instruments and the guidance on the derivatives scope exception for contracts in an entity’s own equity. For convertible instruments, the FASB decided to reduce the number of accounting models for convertible debt instruments and convertible preferred stock. For contracts in an entity’s own equity, the FASB observed that the application of the derivatives scope exception guidance results in accounting for some contracts as derivatives while accounting for economically similar contracts as equity. The FASB also decided to improve and amend the related earnings per share guidance. 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. We adopted ASU 2020-06 as of January 1, 2024 and it did not have a material impact on our condensed consolidated financial statements.

New Accounting Pronouncements – Issued But Not Yet Adopted

In March 2024, the FASB issued ASU 2024-01, Accounting for Application of Profits Interest and Similar Awards, or ASU 2024-01. The key elements of ASU 2024-01 aim to account for profit interest awards as compensation to employees or nonemployees in return for goods and services effective for annual periods beginning after December 15, 2024 and interim periods with those annual periods. 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.

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - STOCK BASED COMPENSATION (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2024	Sep. 30, 2023
Stock-Based Compensation Expense
Total stock-based compensation expense	$ 6,890	$ 7,204	$ 24,392	$ 14,110
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Abstract]
Stock-based compensation capitalized	300		400
Research and development
Stock-Based Compensation Expense
Total stock-based compensation expense	1,904	2,951	7,960	5,847
Selling, general and administrative
Stock-Based Compensation Expense
Total stock-based compensation expense	$ 4,986	$ 4,253	$ 16,432	$ 8,263

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands	Total	Common Stock	Additional Paid-In Capital	Accumulated Deficit	Accumulated Other Comprehensive Gain (Loss)
Balances at Dec. 31, 2022	$ 79,998	$ 390	$ 1,493,469	$ (1,413,642)	$ (219)
Balances (in shares) at Dec. 31, 2022		390,262,524
Increase (Decrease) in Stockholders' Equity
Net loss	(38,122)			(38,122)
Other comprehensive income (loss)	75				75
Foreign currency translation adjustment	(16)				(16)
Issuances of common stock and pre-funded warrant to purchase common stock in public offering, net of issuance costs	213,337	$ 68	213,269
Issuances of common stock and pre-funded warrant to purchase common stock in public offering, net of issuance costs (in shares)		68,007,741
Issuances of common stock in connection with exercise of warrants	59,835	$ 45	59,790
Issuances of common stock in connection with exercise of warrants (in shares)		44,983,193
Stock-based compensation related to issuance of common stock and options for services	112	$ 1	111
Stock-based compensation related to issuance of common stock and options for services (in shares)		9,360
Issuance of common stock under equity plans	7,875	$ 5	7,870
Issuance of common stock under equity plans (in shares)		5,469,028
Stock-based compensation for equity-based awards to employees and directors	2,961		2,961
Balances at Mar. 31, 2023	326,055	$ 509	1,777,470	(1,451,764)	(160)
Balances (in shares) at Mar. 31, 2023		508,731,846
Balances at Dec. 31, 2022	79,998	$ 390	1,493,469	(1,413,642)	(219)
Balances (in shares) at Dec. 31, 2022		390,262,524
Increase (Decrease) in Stockholders' Equity
Net loss	(132,154)
Balances at Sep. 30, 2023	290,614	$ 542	1,836,818	(1,545,796)	(950)
Balances (in shares) at Sep. 30, 2023		542,479,666
Balances at Mar. 31, 2023	326,055	$ 509	1,777,470	(1,451,764)	(160)
Balances (in shares) at Mar. 31, 2023		508,731,846
Increase (Decrease) in Stockholders' Equity
Net loss	(49,227)			(49,227)
Other comprehensive income (loss)	(786)				(786)
Foreign currency translation adjustment	1				1
Issuances of common stock in connection with exercise of warrants	17,767	$ 13	17,754
Issuances of common stock in connection with exercise of warrants (in shares)		12,842,857
Stock-based compensation related to issuance of common stock and options for services	99		99
Stock-based compensation related to issuance of common stock and options for services (in shares)		6,327
Issuance of common stock under equity plans	573		573
Issuance of common stock under equity plans (in shares)		361,074
Stock-based compensation for equity-based awards to employees and directors	3,945		3,945
Balances at Jun. 30, 2023	298,427	$ 522	1,799,841	(1,500,991)	(945)
Balances (in shares) at Jun. 30, 2023		521,942,104
Increase (Decrease) in Stockholders' Equity
Net loss	(44,805)			(44,805)
Other comprehensive income (loss)	(11)				(11)
Foreign currency translation adjustment	6				6
Issuances of common stock in connection with exercise of warrants	440		440
Issuances of common stock in connection with exercise of warrants (in shares)		9,581
Stock-based compensation related to issuance of common stock and options for services	28,309	$ 19	28,290
Stock-based compensation related to issuance of common stock and options for services (in shares)		19,523,808
Issuance of common stock under equity plans	1,044	$ 1	1,043
Issuance of common stock under equity plans (in shares)		1,004,173
Stock-based compensation for equity-based awards to employees and directors	7,204		7,204
Balances at Sep. 30, 2023	290,614	$ 542	1,836,818	(1,545,796)	(950)
Balances (in shares) at Sep. 30, 2023		542,479,666
Balances at Dec. 31, 2023	247,949	$ 545	1,844,988	(1,597,769)	185
Balances (in shares) at Dec. 31, 2023		544,912,215
Increase (Decrease) in Stockholders' Equity
Net loss	(55,390)			(55,390)
Other comprehensive income (loss)	(448)				(448)
Foreign currency translation adjustment	(10)				(10)
Issuances of common stock and pre-funded warrant to purchase common stock in public offering, net of issuance costs	141,000	$ 42	140,958
Issuances of common stock and pre-funded warrant to purchase common stock in public offering, net of issuance costs (in shares)		41,999,998
Issuances of common stock in connection with exercise of warrants	49		49
Issuances of common stock in connection with exercise of warrants (in shares)		37,640
Stock-based compensation related to issuance of common stock and options for services	92		92
Stock-based compensation related to issuance of common stock and options for services (in shares)		2,462
Issuance of common stock under equity plans	6,749	$ 4	6,745
Issuance of common stock under equity plans (in shares)		4,211,493
Stock-based compensation for equity-based awards to employees and directors	4,877		4,877
Balances at Mar. 31, 2024	344,868	$ 591	1,997,709	(1,653,159)	(273)
Balances (in shares) at Mar. 31, 2024		591,163,808
Balances at Dec. 31, 2023	247,949	$ 545	1,844,988	(1,597,769)	185
Balances (in shares) at Dec. 31, 2023		544,912,215
Increase (Decrease) in Stockholders' Equity
Employee stock purchases	366	$ 366
Employee stock purchases (in shares)		201,052
Balances at Jun. 30, 2024	306,695	$ 601	2,027,173	(1,720,542)	(537)
Balances (in shares) at Jun. 30, 2024		601,048,108
Balances at Dec. 31, 2023	247,949	$ 545	1,844,988	(1,597,769)	185
Balances (in shares) at Dec. 31, 2023		544,912,215
Increase (Decrease) in Stockholders' Equity
Net loss	(149,220)
Balances at Sep. 30, 2024	292,284	$ 603	2,037,653	(1,746,989)	1,017
Balances (in shares) at Sep. 30, 2024		603,102,073
Balances at Mar. 31, 2024	344,868	$ 591	1,997,709	(1,653,159)	(273)
Balances (in shares) at Mar. 31, 2024		591,163,808
Increase (Decrease) in Stockholders' Equity
Net loss	(67,383)			(67,383)
Other comprehensive income (loss)	(243)				(243)
Foreign currency translation adjustment	(21)				(21)
Offering expenses	(271)		(271)
Issuances of common stock in connection with exercise of warrants	365		365
Issuances of common stock in connection with exercise of warrants (in shares)		281,211
Stock-based compensation related to issuance of common stock and options for services	16	$ 1	15
Stock-based compensation related to issuance of common stock and options for services (in shares)		1,916
Issuance of common stock under equity plans	16,373	$ 9	16,364
Issuance of common stock under equity plans (in shares)		9,400,121
Stock-based compensation for equity-based awards to employees and directors	12,625		12,625
Balances at Jun. 30, 2024	306,695	$ 601	2,027,173	(1,720,542)	(537)
Balances (in shares) at Jun. 30, 2024		601,048,108
Increase (Decrease) in Stockholders' Equity
Net loss	(26,447)			(26,447)
Other comprehensive income (loss)	1,507				1,507
Foreign currency translation adjustment	47				47
Issuances of common stock in connection with exercise of warrants	4		4
Issuances of common stock in connection with exercise of warrants (in shares)		3,080
Stock-based compensation related to issuance of common stock and options for services	14		14
Stock-based compensation related to issuance of common stock and options for services (in shares)		1,767
Issuance of common stock under equity plans	3,574	$ 2	3,572
Issuance of common stock under equity plans (in shares)		2,049,118
Stock-based compensation for equity-based awards to employees and directors	6,890		6,890
Balances at Sep. 30, 2024	$ 292,284	$ 603	$ 2,037,653	$ (1,746,989)	$ 1,017
Balances (in shares) at Sep. 30, 2024		603,102,073

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

9 Months Ended

Sep. 30, 2024

Accounting Policies [Abstract]

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Basis of Presentation

Principles of Consolidation

Net Loss Per Share

Use of Estimates

Accounts Receivable

Inventory

Cost of Goods Sold

Fair Value of Financial Instruments

Cash Equivalents and Marketable Securities

Leases

Debt Issuance Costs and Debt Discounts

Revenue Recognition

Net Product Revenues

Other Allowances

Discounts for Prompt Payment

We provide for prompt payment discounts to our customers, which are recorded as a reduction in gross product revenue in the same period that the related product revenue is recognized.

Product Returns

Chargebacks

Government Rebates

Co-payment Assistance

License Agreements

Royalties

Restricted Cash

Restricted cash consists of funds maintained in separate money market or certificate of deposit accounts for credit card purchases.

Research and Development Expenses

Depreciation and Amortization

Stock-Based Compensation


	Three Months Ended September 30,				Nine Months Ended September 30,
(In thousands)	2024		2023		2024		2023
Research and development	$	1,904	$	2,951	$	7,960	$	5,847
Selling, general and administrative		4,986		4,253		16,432		8,263
Total stock-based compensation expense	$	6,890	$	7,204	$	24,392	$	14,110

Stock-based compensation of $0.3 million and $0.4 million was capitalized to inventory for the three and nine months ended September 30, 2024, respectively.

Stock Options


	Nine Months Ended September 30,
	2024	2023
Dividend yield	0%	0%
Expected volatility range	82.94% to 86.68%	81.53% to 82.12%
Risk-free interest rate range	3.53% to 4.62%	3.42% to 4.62%
Expected term	6 years	6 years

Employee Stock Purchase Plan


	Nine Months Ended September 30,
	2024	2023
Dividend yield	0%	0%
Expected volatility range	72.08% to 119%	79.05% to 83.22%
Risk-free interest rate range	4.79% to 5.37%	4.73% to 5.40%
Expected term range	6 months to 12 months	6 months to 12 months

Non-Employee Stock-Based Awards

Segment Information

Recent Accounting Pronouncements

New Accounting Pronouncements – Recently Adopted

New Accounting Pronouncements – Issued But Not Yet Adopted

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.

STOCKHOLDERS' EQUITY

9 Months Ended

Sep. 30, 2024

Stockholders' Equity Note [Abstract]

STOCKHOLDERS' EQUITY

8. STOCKHOLDERS’ EQUITY

Registered Offering

On March 21, 2024, we completed an underwritten public offering of 41,999,998 shares of our common stock and a pre-funded warrant to purchase 8,002,668 shares of our common stock, or the 2024 pre-funded warrant. All of the securities were issued separately. The public offering price of the common stock was $3.00 per share. The public offering price of the 2024 pre-funded warrant was $2.99 per share. The 2024 pre-funded warrant has an exercise price of $0.001 per share and may be exercised at any time until the 2024 pre-funded warrant is exercised in full. As of September 30, 2024, none of the 2024 pre-funded warrant has been exercised. The net cash proceeds from the March 2024 offering were approximately $141.0 million, after deducting the underwriting discount and other offering expenses paid by us, and excluding any future proceeds from the exercise of the pre-funded warrant.

Upon the issuance of the 2024 pre-funded warrant, we evaluated the warrant terms 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. Warrants are classified as liabilities when the warrant terms allow settlement of the warrant exercise in cash and classified as equity when the warrant terms only allow settlement in shares of common stock. The terms of the 2024 pre-funded warrant include certain provisions related to fundamental transactions and a cashless exercise provision in the event registered shares are not available, and do not include any mandatory redemption provisions. Based on our evaluation, we concluded the 2024 pre-funded warrant should be classified as equity with no subsequent remeasurement as long as such warrant continue to be classified as equity.

Warrant Exercises

In the first quarter of 2024, warrants to purchase 37,640 shares of our common stock were exercised for net cash proceeds of approximately $49,000. In the second quarter of 2024, warrants to purchase 281,211 shares of our common stock were exercised for net cash proceeds of approximately $365,000. In the third quarter of 2024, warrants to purchase 3,080 shares of our common stock were exercised for net cash proceeds of approximately $4,000. The warrants were issued in connection with underwritten public offerings of common stock and pre-funded warrants, together with accompanying stock purchase warrants in May 2020. As of September 30, 2024, the following warrants remained outstanding:

•

pre-funded warrants with an exercise price of $0.001 per share to purchase 59,433,145 shares of our common stock, which have no expiration date; and

•

stock purchase warrants with an exercise price of $1.30 per share to purchase 2,152,570 shares of our common stock related to the public offering of our common stock in May 2020, which expire on December 31, 2025.

REVENUE RECOGNITON

9 Months Ended

Sep. 30, 2024

Revenue from Contract with Customer [Abstract]

REVENUE RECOGNITON

2. REVENUE RECOGNITON

Net Product Revenue

To date, our only source of product revenue has been from the U.S. sales of RYTELO, which we began shipping to our customers in June 2024. The reconciliation of gross product sales to net product sales by each significant category of gross-to-net adjustments was as follows for the three and nine months ended September 30, 2024 (in thousands):


	Three Months Ended			Nine Months Ended
	September 30,			September 30,
	(in thousands)			(in thousands)
Gross product revenue	$	32,657		$	33,547
Gross-to-net adjustments:
Chargebacks and distributor service fees		(4,002	)		(4,099	)
Government rebates		(364	)		(375	)
Sales returns and allowances		(82	)		(84	)
Total gross-to-net adjustments (1)	$	(4,448	)	$	(4,558	)
Net product revenue	$	28,209		$	28,989

(1)

As of September 30, 2024 approximately $1.4 million of estimated gross-to-net accruals have been recorded within accounts payable and accrued expenses on the condensed consolidated balance sheets.

- Definition

The entire disclosure of revenue from contract with customer to transfer good or service and to transfer nonfinancial asset. Includes, but is not limited to, disaggregation of revenue, credit loss recognized from contract with customer, judgment and change in judgment related to contract with customer, and asset recognized from cost incurred to obtain or fulfill contract with customer. Excludes insurance and lease contracts.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 9
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479806/606-10-50-9

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 10
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479806/606-10-50-10

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 15
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479806/606-10-50-15

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 12
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479806/606-10-50-12

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 12
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479806/606-10-50-12

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 12
-Subparagraph (c)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479806/606-10-50-12

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 12
-Subparagraph (d)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479806/606-10-50-12

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 12
-Subparagraph (e)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479806/606-10-50-12

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 606
-SubTopic 10
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Subparagraph (b)(2)
-Publisher FASB
-URI https://asc.fasb.org/1943274/2147479806/606-10-50-13

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Name Accounting Standards Codification
-Topic 606
-Publisher FASB
-URI https://asc.fasb.org/606/tableOfContent

+ Details