Item 1. Financial Statements
ITEM 1. FINANCIAL STATEMENTS (UNAUDITED)
GERON CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(IN THOUSANDS)
SEPTEMBER 30,
DECEMBER 31,
2024
2023
ASSETS
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 expenses 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
$
444,950
$
394,076
LIABILITIES AND STOCKHOLDERS' EQUITY
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
$
444,950
$
394,076
See accompanying notes.
3
GERON CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(IN THOUSANDS, EXCEPT SHARE AND PER SHARE DATA)
(UNAUDITED)
THREE MONTHS ENDED
NINE MONTHS ENDED
SEPTEMBER 30,
SEPTEMBER 30,
2024
2023
2024
2023
Revenues:
Product revenue, net
28,209
—
28,989
—
Royalties
62
164
468
214
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 and diluted net loss per share
$
( 0.04
)
$
( 0.08
)
$
( 0.23
)
$
( 0.23
)
Shares used in computing
basic and diluted net loss per share
662,158,182
579,508,305
639,933,612
562,445,577
See accompanying notes.
4
GERON CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(IN THOUSANDS)
(UNAUDITED)
THREE MONTHS ENDED
NINE MONTHS ENDED
SEPTEMBER 30,
SEPTEMBER 30,
2024
2023
2024
2023
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
)
See accompanying notes.
5
GERON CORPORATION
CONDENSED CONSOLIDATED STATEMENTS O F STOCKHOLDERS’ EQUITY
(IN THOUSANDS, EXCEPT SHARE DATA)
(UNAUDITED)
Accumulated
Additional
Other
Total
Common Stock
Paid-In
Accumulated
Comprehensive
Stockholders'
Shares
Amount
Capital
Deficit
Gain (Loss)
Equity
Balance at December 31, 2023
544,912,215
$
545
$
1,844,988
$
( 1,597,769
)
$
185
$
247,949
Net loss
—
—
—
( 55,390
)
—
( 55,390
)
Other comprehensive 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 of $ 9,000
41,999,998
42
140,958
—
—
141,000
Issuances of common stock in
connection with exercise of
warrants
37,640
—
49
—
—
49
Issuances of common stock
under equity plans
4,211,493
4
6,745
—
—
6,749
Stock-based compensation related to
issuances of common stock and
options for services
2,462
—
92
—
—
92
Stock-based compensation for
equity-based awards to
employees and directors
—
—
4,877
—
—
4,877
Balance at March 31, 2024
591,163,808
$
591
$
1,997,709
$
( 1,653,159
)
$
( 273
)
$
344,868
Net loss
—
—
—
( 67,383
)
—
( 67,383
)
Other comprehensive loss
—
—
—
—
( 243
)
( 243
)
Foreign currency translation
adjustment
—
—
—
—
( 21
)
( 21
)
Offering expenses
—
—
( 271
)
—
—
( 271
)
Issuances of common stock in
connection with exercise of
warrants
281,211
—
365
—
—
365
Stock-based compensation related
to issuances of common stock
and options in exchange
for services
1,916
1
15
—
—
16
Issuances of common stock
under equity plans
9,400,121
9
16,364
—
—
16,373
Stock-based compensation for
equity-based awards to
employees and directors
—
—
12,625
—
—
12,625
Employee stock purchases
201,052
—
366
—
—
366
Balance at June 30, 2024
601,048,108
$
601
$
2,027,173
$
( 1,720,542
)
$
( 537
)
$
306,695
Net loss
—
—
—
( 26,447
)
—
( 26,447
)
Other comprehensive income
—
—
—
—
1,507
1,507
Foreign currency translation
adjustment
—
—
—
—
47
47
Issuance of common stock in
connection with exercise of
warrants
3,080
—
4
—
—
4
Stock-based compensation related
to issuance of common stock
and options in exchange
for services
1,767
—
14
—
—
14
Issuance of common stock
under equity plans
2,049,118
2
3,572
—
—
3,574
Stock-based compensation for
equity-based awards to
employees and directors
—
—
6,890
—
—
6,890
Balance at September 30, 2024
603,102,073
$
603
$
2,037,653
$
( 1,746,989
)
$
1,017
$
292,284
6
GERON CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(IN THOUSANDS, EXCEPT SHARE DATA)
(UNAUDITED)
Accumulated
Additional
Other
Total
Common Stock
Paid-In
Accumulated
Comprehensive
Stockholders'
Shares
Amount
Capital
Deficit
Gain (Loss)
Equity
Balance at December 31, 2022
390,262,524
$
390
$
1,493,469
$
( 1,413,642
)
$
( 219
)
$
79,998
Net loss
—
—
—
( 38,122
)
—
( 38,122
)
Other comprehensive income
—
—
—
—
75
75
Foreign currency translation
adjustment
—
—
—
—
( 16
)
( 16
)
Issuance of common stock and
pre-funded warrant to purchase
common stock in public
offering, net of issuance
costs of $ 14,507
68,007,741
68
213,269
—
—
213,337
Issuance of common stock in
connection with exercise of
warrants
44,983,193
45
59,790
—
—
59,835
Stock-based compensation related
to issuance of common stock
and options in exchange
for services
9,360
1
111
—
—
112
Issuance of common stock
under equity plans
5,469,028
5
7,870
—
—
7,875
Stock-based compensation for
equity-based awards to
employees and directors
—
—
2,961
—
—
2,961
Balance at March 31, 2023
508,731,846
$
509
$
1,777,470
$
( 1,451,764
)
$
( 160
)
$
326,055
Net loss
—
—
—
( 49,227
)
—
( 49,227
)
Other comprehensive loss
—
—
—
—
( 786
)
( 786
)
Foreign currency translation
adjustment
—
—
—
—
1
1
Issuance of common stock in
connection with exercise of
warrants
12,842,857
13
17,754
—
—
17,767
Stock-based compensation related
to issuances of common stock
and options in exchange
for services
6,327
—
99
—
—
99
Issuance of common stock
under equity plans
361,074
—
573
—
—
573
Stock-based compensation for
equity-based awards to
employees and directors
—
—
3,945
—
—
3,945
Balance at June 30, 2023
521,942,104
$
522
$
1,799,841
$
( 1,500,991
)
$
( 945
)
$
298,427
Net loss
—
—
—
( 44,805
)
—
( 44,805
)
Other comprehensive loss
—
—
—
—
( 11
)
( 11
)
Foreign currency translation
adjustment
—
—
—
—
6
6
Stock-based compensation
related to issuance of common
stock and options in exchange
for services
19,523,808
19
28,290
—
—
28,309
Issuance of common stock in
connection with exercise of
warrants
9,581
—
440
440
Issuances of common stock
under equity plans
1,004,173
1
1,043
—
—
1,044
Stock-based compensation for
equity-based awards to
employees and directors
—
—
7,204
—
—
7,204
Balance at September 30, 2023
542,479,666
$
542
$
1,836,818
$
( 1,545,796
)
$
( 950
)
$
290,614
7
See accompanying notes.
8
GERON CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(IN THOUSANDS)
(UNAUDITED)
NINE MONTHS ENDED
SEPTEMBER 30,
2024
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 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
See accompanying notes.
9
GERON CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER 30, 2024
(UNAUDITED )
1. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
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.
10
GERON CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER 30, 2024
(UNAUDITED )
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
11
GERON CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER 30, 2024
(UNAUDITED )
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
12
GERON CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER 30, 2024
(UNAUDITED )
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.
13
GERON CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER 30, 2024
(UNAUDITED )
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.
14
GERON CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER 30, 2024
(UNAUDITED )
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.
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
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
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.
15
GERON CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER 30, 2024
(UNAUDITED )
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.
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
16
GERON CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER 30, 2024
(UNAUDITED )
(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.
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
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
17
GERON CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER 30, 2024
(UNAUDITED )
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
18
GERON CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER 30, 2024
(UNAUDITED )
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
)
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.
19
GERON CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER 30, 2024
(UNAUDITED )
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.
5. ACCRUED LIABILITIES
Accrued liabilities consisted of the following as o f 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
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
20
GERON CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER 30, 2024
(UNAUDITED )
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.
21
GERON CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER 30, 2024
(UNAUDITED )
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.
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
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GERON CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER 30, 2024
(UNAUDITED )
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 appro ximately $ 62.4 milli on 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.
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 th e 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
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GERON CORPORATION
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER 30, 2024
(UNAUDITED )
• 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 .
24
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
25
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. T here 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.
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.