3 unchanged sentences
(Amounts in thousands, except share and per share amounts)
−Removed: June 30, 2023
+Added: September 30, 2023
December 31, 2022
6 unchanged sentences
Property, plant and equipment, net of accumulated amortization and depreciation of
−Removed: $ 58,489 and $ 54,075 at June 30, 2023 and December 31, 2022, respectively
+Added: $ 60,750 and $ 54,075 at September 30, 2023 and December 31, 2022, respectively
Operating lease right-of-use assets
Acquired intangible assets, net of accumulated amortization of $ 17,444 and
−Removed: $ 16,148 at June 30, 2023 and December 31, 2022, respectively
+Added: $ 16,148 at September 30, 2023 and December 31, 2022, respectively
Other long-term assets
17 unchanged sentences
31,620 shares designated, issued, and
−Removed: outstanding at June 30, 2023 and December 31, 2022;
+Added: outstanding at September 30, 2023 and December 31, 2022;
liquidation value
−Removed: of $ 33,779 at June 30, 2023
+Added: of $ 33,833 at September 30, 2023
Common stock, par value $ 0.01 per share;
800,000,000 shares authorized;
−Removed: 367,491,091 and 305,573,397 shares issued at June 30, 2023
+Added: 381,381,803 and 305,573,397 shares issued at September 30, 2023
and December 31, 2022, respectively
11 unchanged sentences
(Amounts in thousands, except per share amounts)
−Removed: Three Months Ended June 30,
−Removed: Six Months Ended June 30,
+Added: Three Months Ended September 30,
+Added: Nine Months Ended September 30,
Research and development
10 unchanged sentences
Other income (expense):
−Removed: Non-operating income (expense)
+Added: Non-operating income
Interest expense, net
10 unchanged sentences
Other comprehensive loss:
−Removed: Foreign currency translation gain (loss)
−Removed: Other comprehensive gain (loss)
+Added: Foreign currency translation loss
+Added: Other comprehensive loss
Comprehensive loss
21 unchanged sentences
Balance at March 31, 2023
−Removed: Other comprehensive income
+Added: Other comprehensive loss
Share-based compensation
7 unchanged sentences
Balance at June 30, 2023
+Added: Other comprehensive loss
+Added: Share-based compensation
+Added: Shares sold at the market
+Added: Payment of CEO payroll in shares
+Added: MiNK stock purchases
+Added: Issuance of shares for services
+Added: Vesting of nonvested shares
+Added: Employee share purchases
+Added: Balance at September 30, 2023
See accompanying notes to unaudited condensed consolidated financial statements.
29 unchanged sentences
Balance at June 30, 2022
+Added: Other comprehensive loss
+Added: Share-based compensation
+Added: Shares sold at the market
+Added: Issuance of shares for services
+Added: Vesting of nonvested shares
+Added: Exercise of stock options and employee share purchases
+Added: Balance at September 30, 2022
See accompanying notes to unaudited condensed consolidated financial statements .
2 unchanged sentences
(Amounts in thousands, except per share amounts)
−Removed: Six Months Ended June 30,
+Added: Nine Months Ended September 30,
Cash flows from operating activities:
22 unchanged sentences
Proceeds from sale of available-for-sale securities
−Removed: Net cash used in investing activities
+Added: Net cash provided by (used in) investing activities
Cash flows from financing activities:
24 unchanged sentences
NOTES TO UNAUDITED CONDENSED CO NSOLIDATED FINANCIAL STATEMENTS
−Removed: June 30, 2023
+Added: September 30, 2023
Note A - Business, Liquidity and Basis of Presentation
3 unchanged sentences
“us,”
−Removed: and “our”) is a clinical-stage company focused on developing therapies that harness the body’s immune system to combat cancer and infections.
−Removed: Our pipeline includes immune-modulatory antibodies, adoptive cell therapies through our subsidiary MiNK Therapeutics, Inc.
+Added: and “our”) is a leading clinical-stage biotechnology company developing therapies targeting cancer with a robust pipeline of immunological agents.
+Added: Our mission is to expand patient populations benefiting from cancer immunotherapy through combination approaches, using a broad repertoire of antibody therapeutics, adoptive cell therapies (through our subsidiary MiNK Therapeutics, Inc.
(“MiNK”)), and vaccine adjuvants (through our subsidiary SaponiQx, Inc.
(“SaponiQx”)).
−Removed: Our approach to Immuno-oncology (“I-O”) emphasizes speed, innovation, and effective combination therapies to drive success.
−Removed: We believe that combination therapies and a deep understanding of each patient’s cancer will significantly expand the patient population benefiting from I-O treatments.
−Removed: In addition to our diverse pipeline, we have built fully integrated capabilities encompassing novel target discovery, antibody generation, cell line development, and good manufacturing practice clinical manufacturing.
−Removed: We believe these integrated capabilities enable us to develop novel candidates on accelerated timelines compared to industry standards.
−Removed: Through strategic partnerships, we leverage our scientific expertise and capabilities to advance innovation in the field.
+Added: We believe that combination therapies and a deep understanding of each patient’s cancer will significantly expand the patient population benefiting from immuno-oncology (“I-O”) treatments.
+Added: In addition to our diverse pipeline, we have established fully integrated capabilities encompassing novel target discovery, antibody generation, cell line development, and good manufacturing practice (GMP) manufacturing.
+Added: We believe these integrated capabilities enable us to develop and, if approved, commercialize novel candidates on accelerated timelines compared to industry standards.
+Added: Through independent development and strategic partnerships, we leverage our scientific expertise and capabilities to drive innovation in the I-O field.
Our I-O portfolio is driven by several platforms and programs, which we plan to utilize individually and in combination:
1 unchanged sentence
Antibody candidate programs, including our lead asset, botensilimab, an Fc-enhanced CTLA-4 antibody.
−Removed: Data presented at the 2023 ESMO World Congress Gastrointestinal Cancer conference (“ESMO GI”) demonstrated significant activity in microsatellite stable colorectal cancer when combined with balstilimab (PD-1).
−Removed: In a late-breaking presentation at ESMO GI, the combination of botensilimab/balstilimab showed a median Overall Survival of 20.9 months for patients without active liver metastases, surpassing the recently reported 12.9 month benchmark with standard of care in this population.
−Removed: In April 2023, the botensilimab/balstilimab combination received Fast Track designation from the United States Food and Drug Administration (“FDA”) for the treatment of non-MSI-H/deficient mismatch repair (dMMR) metastatic colorectal cancer patients without active liver involvement.
−Removed: Our saponin-based vaccine adjuvant platform, primarily centered around our STIMULON TM cultured plant cell (“cpc”) QS-21 adjuvant (“STIMULON cpc QS-21”).
+Added: At a corporate update at the European Society for Medical Oncology in October 2023, we presented updated data based on a total of 70 efficacy evaluable refractory microsatellite stable metastatic colorectal cancer patients with no active liver metastases from the Phase 1 study.
+Added: These patients received the combination of botensilimab (either 1 or 2 mg/kg every 6 weeks) and balstilimab (3 mg/kg every 2 weeks).
+Added: The results showed a survival and efficacy benefit compared to what has been reported for standard of care in a comparable patient population.
+Added: The 12-month overall survival (“OS”) was 74 % with a median OS not yet reached, after a median follow up of 12.3 months, compared to a median OS of 12.9 months reported for standard of care.
+Added: The confirmed overall response rate based on RECIST 1.1 was 24 % compared to 2.8 % reported with standard of care.
+Added: Our saponin-based vaccine adjuvant platform, primarily centered around our STIMULON cultured plant cell (“cpc”) QS-21 adjuvant (“STIMULON cpc QS-21”).
A pipeline of novel allogeneic invariant natural killer T cell therapies for treating cancer and other immune-mediated diseases, controlled by MiNK.
1 unchanged sentence
Our strategy includes developing and commercializing product candidates through existing and new collaborations.
−Removed: Our cash, cash equivalents and short-term investments at June 30, 2023 were $ 157.9 million, a decrease of $ 35.5 million from December 31, 2022 .
−Removed: Cash and cash equivalents of our subsidiary, MiNK, at March 31, 2023, were $ 14.9 million.
+Added: Our cash, cash equivalents and short-term investments at September 30, 2023 were $ 106.3 million, a decrease of $ 87.1 million from December 31, 2022 .
+Added: Cash and cash equivalents of our subsidiary, MiNK, at June 30, 2023, were $ 10.6 million.
MiNK cash can only be accessed by Agenus through a declaration of a dividend by the MiNK Board of Directors or through settlement of intercompany balances.
We have incurred losses since our inception.
−Removed: As of June 30, 2023, we had an accumulated deficit of $ 1.8 billion.
−Removed: We have historically financed our operations through income and revenues generated from corporate partnerships, advance royalty sales and equity issuances.
−Removed: Based on our current plans and projections, we believe our cash resources of $ 157.9 million at June 30, 2023 will be sufficient to satisfy our liquidity needs for more than one year from when these financial statements were issued.
−Removed: Management consistently monitors our liquidity position and has the flexibility to adjust spending as necessary to preserve and extend liquidity.
−Removed: We regularly assess the likelihood of success of our programs, and our funding decisions are based on these evaluations.
−Removed: We are prepared to discontinue funding of any activities that do not impact our core priorities and to restrict capital expenditures and/or reduce the scale of our operations.
−Removed: Potential funding sources may include collaborations, out-licensing and/or partnering opportunities for our portfolio programs and product candidates with multiple parties, milestone payments from our existing partnerships, additional third-party agreements, asset sales, project financing, and/or sales of equity securities.
+Added: As of September 30, 2023, we had an accumulated deficit of $ 1.9 billion.
+Added: We have financed our operations through income and revenues generated from corporate partnerships, advance royalty sales and proceeds from equity issuances.
+Added: Based on our current plans and projections, we believe that our cash resources of $ 106.3 million at September 30, 2023, plus additional funding we anticipate from the achievement of a milestone under an existing partnership, will be sufficient to satisfy our liquidity requirements for at least one year from when these financial statements were issued.
+Added: This milestone will be triggered upon dosing the first patient in a clinical trial which is currently screening patients and is expected to occur by end of 2023.
+Added: However, until this event occurs, in accordance with the relevant accounting guidance we are required to disclose that substantial doubt exists about our ability to continue as a going concern for a period of one year after the date of filing of this Quarterly Report on Form 10-Q.
+Added: In addition to the expected milestone payment by end of 2023, we are in active discussions to sell two non-strategic assets expected to close in the first half of 2024 with an estimated aggregate value of approximately $ 65.0 million.
+Added: These transactions could extend our cash resources well beyond 2024 .
+Added: We are also in advanced discussions for a potential structured financing for
+Added: botensilimab/balstilimab, as well as a potential corporate collaboration with a large pharma or biotech company.
+Added: None of these sources of cash involve equity or debt issuance.
+Added: Management continues to address the Company’s liquidity position and has the flexibility to adjust spending as needed in order to preserve liquidity.
+Added: In August 2023, we prioritized and focused our resources to accelerate the development, registration, and commercialization of our lead asset postponing all preclinical and other clinical programs and reducing our workforce by approximately 25 %.
+Added: Garo Armen has elected to receive his base salary and any potential bonus payments in stock rather than cash.
+Added: We continuously evaluate the likelihood of success of our programs.
+Added: As such, our decisions to continue to fund or eliminate funding of each of our programs are predicated on these determinations, on an ongoing basis.
+Added: We expect our sources of funding to include payments from current collaborations which include milestones and royalty payments from companies, including Bristol-Myers Squibb Company, UroGen Pharma Ltd., Gilead Sciences, Inc., Incyte Corporation, and Merck Sharpe & Dohme;
+Added: out-licensing and/or partnering opportunities for our portfolio programs and product candidates with multiple parties;
+Added: additional third-party agreements;
+Added: royalty monetization;
+Added: project financing, and/or sales of equity securities .
The accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with U.S.
3 unchanged sentences
GAAP for complete annual consolidated financial statements.
−Removed: In the opinion of our management, the condensed consolidated financial statements include all
−Removed: normal and recurring adjustments considered necessary for a fair presentation of our financial position and operating results.
+Added: In the opinion of our management, the condensed consolidated financial statements include all normal and recurring adjustments considered necessary for a fair presentation of our financial position and operating results.
All significant intercompany transactions and accounts have been eliminated in consolidation.
−Removed: Operating results for the six months ended June 30, 2023, are not necessarily indicative of the results that may be expected for the year ending December 31, 2023.
+Added: Operating results for the nine months ended September 30, 2023, are not necessarily indicative of the results that may be expected for the year ending December 31, 2023.
For further information, refer to our consolidated financial statements and footnotes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2022 filed with the Securities and Exchange Commission (“SEC”).
9 unchanged sentences
equity (deficit).
−Removed: During the quarter ended June 30, 2023, we deconsolidated certain foreign subsidiaries and recognized a gain of $ 132,000 , included in "Other income (expense)" on our condensed consolidated statements of operations and comprehensive loss.
+Added: In 2023, we deconsolidated certain foreign subsidiaries and recognized a gain of $ 132,000 , included in "Other income (expense)" on our condensed consolidated statements of operations and comprehensive loss.
Note B - Net Loss Per Share
3 unchanged sentences
Because we reported a net loss attributable to common stockholders for all periods presented, diluted loss per common share is the same as basic loss per common share, as the effect of utilizing the fully diluted share count would have reduced the net loss per common share.
−Removed: The following securities (listed on an as-if-converted-to-Common-Stock basis) have been excluded from the computation of diluted weighted average shares outstanding as of June 30, 2023 and 2022, as they would be anti-dilutive (in thousands):
−Removed: Three and Six Months Ended June 30,
+Added: The following securities (listed on an as-if-converted-to-Common-Stock basis) have been excluded from the computation of diluted weighted average shares outstanding as of September 30, 2023 and 2022, as they would be anti-dilutive (in thousands):
+Added: Three and Nine Months Ended September 30,
Stock options
2 unchanged sentences
Note C - Investments
−Removed: Cash equivalents and short-term investments consisted of the following as of June 30, 2023 and December 31, 2022 (in thousands):
−Removed: June 30, 2023
+Added: Cash equivalents and short-term investments consisted of the following as of September 30, 2023 and December 31, 2022 (in thousands):
+Added: September 30, 2023
December 31, 2022
1 unchanged sentence
Treasury Bills
−Removed: As a result of the short-term nature of these investments, there were minimal unrealized holding gains or losses for the three and six months ended June 30, 2023 and 2022.
−Removed: Of the investments listed above, $ 127.0 million and $ 164.7 million were classified as cash equivalents and $ 14.6 million and $ 14.7 million as short-term investments on our condensed consolidated balance sheets as of June 30, 2023 and December 31, 2022, respectively.
+Added: As a result of the short-term nature of these investments, there were minimal unrealized holding gains or losses for the three and nine months ended September 30, 2023 and 2022.
+Added: Of the investments listed above, all were classified as cash equivalents on our condensed consolidated balance sheets as of September 30, 2023.
+Added: As of December 31, 2022, $ 164.7 million were classified as cash equivalents and $ 14.7 million as short-term investments on our condensed consolidated balance sheets.
Note D - Goodwill and Acquired Intangible Assets
−Removed: The following table sets forth the changes in the carrying amount of goodwill for the six months ended June 30, 2023 (in thousands):
+Added: The following table sets forth the changes in the carrying amount of goodwill for the nine months ended September 30, 2023 (in thousands):
Balance, December 31, 2022
Foreign currency translation adjustment
−Removed: Balance, June 30, 2023
−Removed: Acquired intangible assets consisted of the following as of June 30, 2023 and December 31, 2022 (in thousands):
−Removed: As of June 30, 2023
+Added: Balance, September 30, 2023
+Added: Acquired intangible assets consisted of the following as of September 30, 2023 and December 31, 2022 (in thousands):
+Added: As of September 30, 2023
Gross carrying
8 unchanged sentences
The weighted average amortization period of our finite-lived intangible assets is 9 years.
−Removed: Amortization expense related to acquired intangibles is estimated at $ 0.6 million for the remainder of 2023, $ 0.6 million for the year ending December 31, 2024, $ 0.5 million for the years ending December 31, 2025 and 2026 and $ 0.4 million for the year ending December 31, 2027.
+Added: Amortization expense related to acquired intangibles is estimated at $ 0.1 million for the remainder of 2023, $ 0.5 million for the years ending December 31, 2024, 2025 and 2026 and $ 0.4 million for the year ending December 31, 2027.
Note E - Debt
−Removed: Debt obligations consisted of the following as of June 30, 2023 and December 31, 2022 (in thousands):
+Added: Debt obligations consisted of the following as of September 30, 2023 and December 31, 2022 (in thousands):
Debt instrument
+Added: September 30,
Current Portion:
5 unchanged sentences
2015 Subordinated Notes
−Removed: As of both June 30, 2023 and December 31, 2022, the principal amount of our outstanding debt balance was $ 13.6 million.
+Added: As of September 30, 2023 and December 31, 2022, the principal amount of our outstanding debt balance was $ 13.4 million and $ 13.6 million, respectively.
Note F –
Liability Related to the Sale of Future Royalties and Milestones
−Removed: The following table shows the activity within the liability account in the six months ended June 30, 2023 (in thousands):
+Added: The following table shows the activity within the liability account in the nine months ended September 30, 2023 (in thousands):
December 31, 2022 to
−Removed: June 30, 2023
+Added: September 30, 2023
Liability related to sale of future royalties and milestones - beginning balance
12 unchanged sentences
The liability is classified between the current and non-current portion of liability related to sale of future royalties and milestones in the condensed consolidated balance sheets based on the estimated royalty payments to be received by HCR in the next 12 months from the financial statement reporting date.
−Removed: During the six months ended June 30, 2023 , we recognized $ 41.2 million of non-cash royalty revenue, and we recorded $ 36.8 million of related non-cash interest expense related to the HCR Royalty Purchase Agreement.
+Added: During the nine months ended September 30, 2023 , we recognized $ 61.5 million of non-cash royalty revenue, and we recorded $ 55.8 million of related non-cash interest expense related to the HCR Royalty Purchase Agreement.
As royalties are remitted to HCR from GSK, the balance of the recorded liability will be effectively repaid over the life of the HCR Royalty Purchase Agreement.
2 unchanged sentences
Periodically, we assess the estimated royalty payments to be paid to HCR from GSK, and to the extent the amount or timing of the payments is materially different from our original estimates, we will prospectively adjust the amortization of the liability, and the related recognition of interest expense.
−Removed: During the six months ended June 30, 2023 , our estimate of the effective annual interest rate over the life of the agreement increased to 30.4 %, which results in a life of contract interest rate of 23.6 %.
+Added: During the nine months ended September 30, 2023 , our estimate of the effective annual interest rate over the life of the agreement increased to 29.4 %, which results in a life of contract interest rate of 23.4 %.
Note G - Accrued and Other Current Liabilities
−Removed: Accrued liabilities consisted of the following as of June 30, 2023 and December 31, 2022 (in thousands):
−Removed: June 30, 2023
+Added: Accrued liabilities consisted of the following as of September 30, 2023 and December 31, 2022 (in thousands):
+Added: September 30, 2023
December 31, 2022
2 unchanged sentences
Research services
−Removed: Other current liabilities consisted of the following as of June 30, 2023 and December 31, 2022 (in thousands):
−Removed: June 30, 2023
+Added: Other current liabilities consisted of the following as of September 30, 2023 and December 31, 2022 (in thousands):
+Added: September 30, 2023
December 31, 2022
2 unchanged sentences
Assets and liabilities measured at fair value are summarized below (in thousands):
−Removed: June 30, 2023
+Added: September 30, 2023
Quoted Prices in
1 unchanged sentence
Cash equivalents (Note C)
−Removed: Short-term investments (Note C)
Long-term investments
6 unchanged sentences
Contingent purchase price consideration
+Added: Long-term investments are included in "Other long-term assets" in our condensed consolidated balance sheets.
We measure our contingent purchase price considerations at fair value.
−Removed: The fair values of our contingent purchase price considerations at June 30, 2023 and December 31, 2022, of $ 0.5 million and $ 0.9 million, respectively, included in "Other long-term liabilities" in our condensed consolidated balance sheets, are based on significant inputs not observable in the market, which require them to be reported as Level 3 liabilities within the fair value hierarchy.
+Added: The fair values of our contingent purchase price considerations at September 30, 2023 and December 31, 2022, of $ 0.5 million and $ 0.9 million, respectively, included in "Other long-term liabilities" in our condensed consolidated balance sheets, are based on significant inputs not observable in the market, which require them to be reported as Level 3 liabilities within the fair value hierarchy.
The valuation of these liabilities use assumptions we believe would be made by a market participant and are mainly based on estimates from a Monte Carlo simulation of our share price, as well as other factors impacting the probability of triggering the milestone payments.
Share price was evolved using a geometric Brownian motion, calculated daily for the life of the contingent purchase price considerations.
−Removed: The fair value of our outstanding debt balance at June 30, 2023 and December 31, 2022 was $ 13.3 million and $ 13.2 million, respectively, based on the Level 2 valuation hierarchy of the fair value measurements standard using a present value methodology that was derived by evaluating the nature and terms of each note and considering the prevailing economic and market conditions at the balance sheet date.
−Removed: The principal amount of our outstanding debt balance at both June 30, 2023 and December 31, 2022 was $ 13.6 million.
+Added: The fair value of our outstanding debt balance at September 30, 2023 and December 31, 2022 was $ 13.1 million and $ 13.2 million, respectively, based on the Level 2 valuation hierarchy of the fair value measurements standard using a present value methodology that was derived by evaluating the nature and terms of each note and considering the prevailing economic and market conditions at the balance sheet date.
+Added: The principal amount of our outstanding debt balance at September 30, 2023 and December 31, 2022 was $ 13.4 million and $ 13.6 million, respectively.
Note I - Revenue from Contracts with Customers
2 unchanged sentences
(“Gilead”) focused on the development and commercialization of up to five novel immuno-oncology therapies.
−Removed: Pursuant to the terms of the license agreement, the option and license agreements and the stock purchase agreement we entered into with Gilead (collectively, the “Gilead
−Removed: Collaboration Agreements”), at the closing of the transaction on January 23, 2019, we received an upfront cash payment from Gilead of $ 120.0 million and Gilead made a $ 30.0 million equity investment in Agenus.
+Added: Pursuant to the terms of the license agreement, the option and license agreements and the stock purchase agreement we entered into with Gilead (collectively, the “Gilead Collaboration Agreements”), at the closing of the transaction on January 23, 2019, we received an upfront cash payment from Gilead of $ 120.0 million and Gilead made a $ 30.0 million equity investment in Agenus.
On November 6, 2020, we received notice from Gilead that it was returning AGEN1423 to us and voluntarily terminating the applicable license agreement.
4 unchanged sentences
Collaboration Revenue
−Removed: For the three months ended June 30, 2023 and 2022, we recognized approximately $ 2.0 million and $ 1.2 million, respectively, of research and development revenue based on the partial satisfaction of the over time performance obligations as of quarter end.
−Removed: For the six months ended June 30, 2023, we recognized approximately $ 4.4 million of research and development revenue based on the partial satisfaction of the over time performance obligations as of period end.
−Removed: For the six months ended June 30, 2022, we recognized research and development revenue of $ 5.0 million related to the achievement of a milestone and $ 2.6 million based on the partial satisfaction of the over time performance obligations as of period end.
−Removed: We expect to recognize deferred research and development revenue of $ 7.8 million for the remainder of 2023 related to performance obligations that are unsatisfied or partially unsatisfied as of June 30, 2023.
+Added: For the three months ended September 30, 2023 and 2022, we recognized approximately $ 2.9 million and $ 4.5 million, respectively, of research and development revenue based on the partial satisfaction of the over time performance obligations as of quarter end.
+Added: For the nine months ended September 30, 2023, we recognized approximately $ 7.2 million of research and development revenue based on the partial satisfaction of the over time performance obligations as of period end.
+Added: For the nine months ended September 30, 2022, we recognized research and development revenue of $ 5.0 million related to the achievement of a milestone and $ 7.1 million based on the partial satisfaction of the over time performance obligations as of period end.
+Added: We expect to recognize deferred research and development revenue of $ 5.0 million for the remainder of 2023 related to performance obligations that are unsatisfied or partially unsatisfied as of September 30, 2023.
Disaggregation of Revenue
−Removed: The following table presents revenue (in thousands) for the three and six months ended June 30, 2023 and 2022, disaggregated by geographic region and revenue type.
+Added: The following table presents revenue (in thousands) for the three and nine months ended September 30, 2023 and 2022, disaggregated by geographic region and revenue type.
Revenue by geographic region is allocated based on the domicile of our respective business operations.
−Removed: Three months ended June 30, 2023
+Added: Three months ended September 30, 2023
United States
2 unchanged sentences
Other services
+Added: Clinical product revenue
Recognition of deferred revenue
Non-cash royalties
−Removed: Three months ended June 30, 2022
+Added: Three months ended September 30, 2022
Royalty sales milestone
3 unchanged sentences
Non-cash royalties
−Removed: Six months ended June 30, 2023
+Added: Nine months ended September 30, 2023
United States
2 unchanged sentences
Other services
+Added: Clinical product revenue
Recognition of deferred revenue
Non-cash royalties
−Removed: Six months ended June 30, 2022
+Added: Nine months ended September 30, 2022
License fees and milestones
12 unchanged sentences
The following table provides information about contract liabilities from contracts with customers (in thousands):
−Removed: Six months ended June 30, 2023
+Added: Nine months ended September 30, 2023
Balance at beginning of period
2 unchanged sentences
Deferred revenue
−Removed: The change in contract liabilities is primarily related to the recognition of $ 4.4 million of revenue related to the Gilead Collaboration Agreements during the six months ended June 30, 2023 .
−Removed: Deferred revenue related to the Gilead Collaboration Agreements of $ 7.8 million as of June 30, 2023 , which was comprised of the $ 142.5 million initial transaction price, less $ 134.7 million of license and collaboration revenue recognized from the effective date of the contract, will be recognized as the combined performance obligation is satisfied.
−Removed: We also recorded a $ 1.3 million receivable as of June 30, 2023, for research and development and other services provided.
−Removed: During the six months ended June 30, 2023 , we did not recognize any revenue from amounts included in the contract asset or the contract liability balances from performance obligations satisfied in previous periods.
+Added: The change in contract liabilities is primarily related to the recognition of $ 7.2 million of revenue related to the Gilead Collaboration Agreements during the nine months ended September 30, 2023 .
+Added: Deferred revenue related to the Gilead Collaboration Agreements of $ 5.0 million as of September 30, 2023 , which was comprised of the $ 142.5 million initial transaction price, less $ 137.5 million of license and collaboration revenue recognized from the effective date of the contract, will be recognized as the combined performance obligation is satisfied.
+Added: We also recorded a $ 1.0 million receivable as of September 30, 2023, for research and development and other services provided.
+Added: During the nine months ended September 30, 2023 , we did not recognize any revenue from amounts included in the contract asset or the contract liability balances from performance obligations satisfied in previous periods.
No ne of the costs to obtain or fulfill a contract were capitalized.
1 unchanged sentence
We primarily use the Black-Scholes option pricing model to value stock options granted to employees and non-employees, including stock options granted to members of our Board of Directors.
−Removed: However, the fair value of stock option market-based awards is
−Removed: calculated based on a Monte Carlo simulation as of the date of issuance.
+Added: However, the fair value of stock option market-based awards is calculated based on a Monte Carlo simulation as of the date of issuance.
All stock options have 10-year terms and generally vest ratably over a 3 or 4 -year period.
−Removed: A summary of option activity for the six months ended June 30, 2023 is presented below:
+Added: A summary of option activity for the nine months ended September 30, 2023 is presented below:
Outstanding at December 31, 2022
−Removed: Outstanding at June 30, 2023
−Removed: Vested or expected to vest at June 30, 2023
−Removed: Exercisable at June 30, 2023
−Removed: The weighted average grant-date fair values of stock options granted during the six months ended June 30, 2023 and 2022 were $ 1.49 and $ 1.76 , respectively.
−Removed: As of June 30, 2023 , there was approximately $ 32.7 million of total unrecognized share-based compensation expense related to these stock options and stock options granted under subsidiary plans which, if all milestones are achieved, will be recognized over a weighted average period of 2.0 years.
+Added: Outstanding at September 30, 2023
+Added: Vested or expected to vest at September 30, 2023
+Added: Exercisable at September 30, 2023
+Added: The weighted average grant-date fair values of stock options granted during the nine months ended September 30, 2023 and 2022 were $ 1.44 and $ 1.77 , respectively.
+Added: As of September 30, 2023 , there was approximately $ 27.3 million of total unrecognized share-based compensation expense related to these stock options and stock options granted under subsidiary plans which, if all milestones are achieved, will be recognized over a weighted average period of 1.9 years.
Certain employees and consultants have been granted non-vested stock.
1 unchanged sentence
The fair value of other non-vested stock is calculated based on the closing sale price of our common stock on the date of issuance.
−Removed: A summary of non-vested stock activity for the six months ended June 30, 2023 is presented below:
+Added: A summary of non-vested stock activity for the nine months ended September 30, 2023 is presented below:
Outstanding at December 31, 2022
−Removed: Outstanding at June 30, 2023
−Removed: As of June 30, 2023 , there was approximately $ 1.2 million of unrecognized share-based compensation expense related to these non-vested shares and non-vested shares granted under subsidiary plans which will be recognized over a period of 2.0 years.
−Removed: During the six months ended June 30, 2023 , 150,291 shares were issued under the 2019 Employee Stock Purchase Plan, 46,750 shares were issued as a result of stock option exercises and 21,666 shares were issued as a result of the vesting of non-vested stock.
+Added: Outstanding at September 30, 2023
+Added: As of September 30, 2023 , there was approximately $ 1.1 million of unrecognized share-based compensation expense related to these non-vested shares and non-vested shares granted under subsidiary plans which will be recognized over a period of 2.3 years.
+Added: During the nine months ended September 30, 2023 , 449,391 shares were issued under the 2019 Employee Stock Purchase Plan, 46,750 shares were issued as a result of stock option exercises and 84,414 shares were issued as a result of the vesting of non-vested stock.
Additionally, 4,643,808 shares were issued as payment for certain employee bonuses, with 1,668,767 of those shares being withheld to cover taxes, resulting in a net share issuance of 2,975,041 .
−Removed: The impact on our results of operations from share-based compensation for the three and six months ended June 30, 2023 and 2022, was as follows (in thousands):
−Removed: Three Months Ended June 30,
−Removed: Six Months Ended June 30,
+Added: The impact on our results of operations from share-based compensation for the three and nine months ended September 30, 2023 and 2022, was as follows (in thousands):
+Added: Three Months Ended September 30,
+Added: Nine Months Ended September 30,
Research and development
3 unchanged sentences
Restricted Cash
−Removed: As of both June 30, 2023, and December 31, 2022 , we maintained non-current restricted cash of $ 2.7 million.
+Added: As of September 30, 2023, and December 31, 2022 , we maintained non-current restricted cash of $ 3.7 million and $ 2.7 million, respectively.
This amount is included within “Other long-term assets”
−Removed: in our condensed consolidated balance sheets and is comprised of letters of credit required under two of our facility leases.
+Added: in our condensed consolidated balance sheets and is comprised of letters of credit required under our facility leases.
The following table provides a reconciliation of cash, cash equivalents and restricted cash that sums to the total of the same such amounts shown in the condensed consolidated statements of cash flows (in thousands):
−Removed: Six Months Ended June 30, 2023
−Removed: Six Months Ended June 30, 2022
+Added: Nine Months Ended September 30, 2023
+Added: Nine Months Ended September 30, 2022
Beginning of Period
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(the “Sales Agent”), dated as of July 22, 2020 (the “Sales Agreement”).
−Removed: Sales pursuant to the Sales Agreement will be made only upon our instruction to the Sales Agent, and we cannot provide assurances that we will issue any additional Placement Shares pursuant to the Sales Agreement.
−Removed: During the three and six months ended June 30, 2023 , we received net proceeds of approximately $ 42.2 million and $ 102.8 million from the sale of approximately 24.6 million and 58.3 million shares of our common stock, respectively, in at-the-market offerings under the Sales Agreement.
+Added: Sales pursuant to the Sales Agreement will be made only upon our
+Added: instruction to the Sales Agent, and we cannot provide assurances that we will issue any additional Placement Shares pursuant to the Sales Agreement.
+Added: During the three and nine months ended September 30, 2023 , we received net proceeds of approximately $ 20.4 million and $ 123.2 million from the sale of approximately 13.3 million and 71.6 million shares of our common stock, respectively, in at-the-market offerings under the Sales Agreement.
Note M –
Non-controlling Interest
−Removed: Non-controlling interest recorded in our condensed consolidated financial statements as of June 30, 2023 and December 31, 2022, relates to the following approximate interests in certain consolidated subsidiaries, which we do not own.
−Removed: June 30, 2023
+Added: Non-controlling interest recorded in our condensed consolidated financial statements as of September 30, 2023 and December 31, 2022, relates to the following approximate interests in certain consolidated subsidiaries, which we do not own.
+Added: September 30, 2023
December 31, 2022
1 unchanged sentence
SaponiQx, Inc.
−Removed: Changes in non-controlling interest for the periods ended June 30, 2023 and December 31, 2022, were as follows (in thousands):
−Removed: June 30, 2023
+Added: Changes in non-controlling interest for the periods ended September 30, 2023 and December 31, 2022, were as follows (in thousands):
+Added: September 30, 2023
December 31, 2022
14 unchanged sentences
Purchase of subsidiary shares
−Removed: In May 2023, we purchased 195,788 shares of MiNK common stock in multiple open market transactions.
+Added: During the nine months ended September 30, 2023, we purchased 408,518 shares of MiNK common stock in multiple open market transactions.
Note N –
2 unchanged sentences
Allison Jeynes, a member of our Board of Directors, is chief executive officer of Avillion.
−Removed: For the three and six months ended June 30, 2023, approximately $ 222,000 and $ 450,000 , respectively, related to these services is included in “Research and development”
+Added: For the nine months ended September 30, 2023, approximately $ 450,000 related to these services is included in “Research and development”
expense in our condensed consolidated statements of operations.
+Added: During the nine months ended September 30, 2023, our Audit and Finance Committee approved, and we performed research and development manufacturing services totaling $ 256,000 for Protagenic Therapeutics, Inc ("Protagenic").
+Added: We will be reimbursed for these services on an actual time and materials basis.
+Added: Armen, our CEO, is Executive Chairman of and has a greater than 10 % equity interest in Protagenic.
Note O - Recent Accounting Pronouncements
5 unchanged sentences
The adoption did no t have a material impact on our consolidated financial statements .
−Removed: No other new accounting pronouncement issued or effective during the six months ended June 30, 2023 had or is expected to have a material impact on our consolidated financial statements or disclosures.
−Removed: Note P –
−Removed: Subsequent Events
−Removed: At the Market Offerings
−Removed: During the period of July 1, 2023 through August 4, 2023, we sold approximately 13.2 million shares of our common stock under the Sales Agreement, totaling net proceeds of approximately $ 20.3 million.
+Added: No other new accounting pronouncement issued or effective during the nine months ended September 30, 2023 had or is expected to have a material impact on our consolidated financial statements or disclosures.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
22 unchanged sentences
More detailed descriptions of these risks and uncertainties and other risks and uncertainties applicable to our business that we believe could cause actual results to differ materially from any forward-looking statements are included in in Part I-Item 1A “Risk Factors”
−Removed: of our Annual Report on Form 10-K for the fiscal year ended December 31, 2022.
+Added: of our Annual Report on Form 10-K for the fiscal year ended December 31, 2022 and in Part II-Item 1A within this Form 10-Q.
We encourage you to read those descriptions carefully.
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All rights reserved.
−Removed: We are a clinical-stage company focused on developing therapies that harness the body’s immune system to combat cancer and infections.
−Removed: Our pipeline includes immune-modulatory antibodies, adoptive cell therapies through our subsidiary MiNK Therapeutics, Inc.
+Added: We are a leading clinical-stage biotechnology company developing therapies targeting cancer with a robust pipeline of immunological agents.
+Added: Our mission is to expand patient populations benefiting from cancer immunotherapy through combination approaches, using a broad repertoire of antibody therapeutics, adoptive cell therapies (through our subsidiary MiNK Therapeutics, Inc.
(“MiNK”)), and vaccine adjuvants (through our subsidiary SaponiQx, Inc.
(“SaponiQx”)).
−Removed: Our approach to Immuno-oncology (“I-O”) emphasizes speed, innovation, and effective combination therapies to drive success.
−Removed: We believe that combination therapies and a deep understanding of each patient’s cancer will significantly expand the patient population benefiting from I-O treatments.
−Removed: In addition to our diverse pipeline, we have built fully integrated capabilities encompassing novel target discovery, antibody generation, cell line development, and good manufacturing practice clinical manufacturing.
−Removed: We believe these integrated capabilities enable us to develop novel candidates on accelerated timelines compared to industry standards.
−Removed: Through strategic partnerships, we leverage our scientific expertise and capabilities to advance innovation in the field.
+Added: We believe that combination therapies and a deep understanding of each patient’s cancer will significantly expand the patient population benefiting from immuno-oncology (“I-O”) treatments.
+Added: In addition to our diverse pipeline, we have established fully integrated capabilities encompassing novel target discovery, antibody generation, cell line development, and good manufacturing practice (GMP) manufacturing.
+Added: We believe these integrated capabilities enable us to develop and, if approved, commercialize novel candidates on accelerated timelines compared to industry standards.
+Added: Through independent development and strategic partnerships, we leverage our scientific expertise and capabilities to drive innovation in the I-O field.
Our I-O portfolio is driven by several platforms and programs, which we plan to utilize individually and in combination:
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Antibody candidate programs, including our lead asset, botensilimab, an Fc-enhanced CTLA-4 antibody.
−Removed: Data presented at the 2023 ESMO World Congress Gastrointestinal Cancer conference (“ESMO GI”) demonstrated significant activity in microsatellite stable colorectal cancer when combined with balstilimab (PD-1).
−Removed: In a late-breaking presentation at ESMO GI, the combination of botensilimab/balstilimab showed a median Overall Survival of 20.9 months for patients without active liver metastases, surpassing the recently reported 12.9 month benchmark with standard of care in this population.
+Added: At a corporate update at the European Society for Medical Oncology in October 2023, we presented updated data based on a total of 70 efficacy evaluable refractory microsatellite stable metastatic colorectal cancer patients with no active liver metastases from the Phase 1 study.
+Added: These patients received the combination of botensilimab (either 1 or 2 mg/kg every 6 weeks) and balstilimab (3 mg/kg every 2 weeks).
+Added: The results showed a survival and efficacy benefit compared to what has been reported for standard of care in a comparable patient population.
+Added: The 12-month overall survival (“OS”) was 74% with a median OS not yet reached, after a median follow up of 12.3 months, compared to a median OS of 12.9 months reported for standard of care.
+Added: The confirmed overall response rate based on RECIST 1.1 was 24% compared to 2.8% reported with standard of care.
Our saponin-based vaccine adjuvant platform, primarily centered around our STIMULON cultured plant cell (“cpc”) QS-21 adjuvant (“STIMULON cpc QS-21”).
2 unchanged sentences
Our lead program, botensilimab (AGEN1181), is progressing through multiple clinical programs designed to support accelerated development as a monotherapy and in combination with balstilimab.
−Removed: In 2022, we initiated global Phase 2 trials for botensilimab in
−Removed: microsatellite stable colorectal cancer, melanoma, and pancreatic cancer.
+Added: In 2022, we initiated global Phase 2 trials for botensilimab in microsatellite stable colorectal cancer, melanoma, and pancreatic cancer.
+Added: In October 2023, we completed enrollment of the Phase 2 microsatellite stable colorectal cancer trial.
In April 2023, the botensilimab/balstilimab combination received Fast Track designation from the United States Food and Drug Administration (“FDA”) for the treatment of non-MSI-H/deficient mismatch repair (dMMR) metastatic colorectal cancer patients without active liver involvement.
−Removed: We intend to file our first biologics license application for the botensilimab/balstilimab combination in colorectal cancer in 2024.
+Added: We intend to file our first biologics license application for the botensilimab/balstilimab combination in colorectal cancer in midyear 2024.
We have established collaborations with several companies, including Bristol-Myers Squibb Company (“BMS”), Betta Pharmaceuticals Co., Ltd.
−Removed: (“Betta”), Gilead Sciences, Inc.
+Added: (“Betta”), UroGen Pharma Ltd.
+Added: ("UroGen"), Gilead Sciences, Inc.
(“Gilead”), Incyte Corporation (“Incyte”), and Merck Sharpe & Dohme (“Merck”).
2 unchanged sentences
Incyte has been advancing these antibodies in clinical trials.
−Removed: Incyte has notified us of their intent to terminate the OX40 program, effective October 2023, and both the GITR program and undisclosed program, effective May 2024.
+Added: Incyte has terminated the OX40 program, effective October 2023, and has notified us of their intent to terminate both the GITR program and undisclosed program, effective May 2024.
Upon termination, the rights to the OX40, GITR, and undisclosed programs revert back to us.
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Pursuant to the agreement, XOMA purchased 33% of all future royalties and 10% of all future milestone payments that we are entitled to receive from Incyte and Merck, after satisfying our obligations to a third party.
−Removed: As of June 30, 2023, we remain eligible to receive up to $283.5 million and $76.5 million in potential development, regulatory, and commercial milestones from Incyte and Merck, respectively, after accounting for our obligations under the XOMA Royalty Purchase Agreement.
+Added: As of September 30, 2023, we remain eligible to receive up to $283.5 million and $76.5 million in potential development, regulatory, and commercial milestones from Incyte and Merck, respectively, after accounting for our obligations under the XOMA Royalty Purchase Agreement.
In December 2018, we entered into collaboration agreements with Gilead for the development and commercialization of up to five novel I-O therapies (the “Gilead Collaboration Agreements”).
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Pursuant to the terms of the AGEN2373 option agreement, we remain eligible to receive a $50.0 million option exercise fee and up to an additional $520.0 million in aggregate milestone payments, as well as royalties on future sales.
+Added: In November 2019, we entered into a license agreement with UroGen, granting them an exclusive, worldwide license (not including Argentina, Brazil, Chile, Colombia, Peru, Venezuela and their respective territories and possessions) to develop, manufacture, and commercialize zalifrelimab for the treatment of cancers of the urinary tract via intravesical delivery.
+Added: We received an upfront payment of $10.0 million and are eligible to receive up to $200.0 million in milestone payments, as well as royalties on future sales.
In June 2020, we entered into a license and collaboration agreement (the “Betta License Agreement”) with Betta, pursuant to which we granted Betta an exclusive license to develop, manufacture and commercialize balstilimab and zalifrelimab in Republic of China, Hong Kong, Macau and Taiwan (“Greater China”).
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Our strategy includes developing and commercializing product candidates through existing and new collaborations.
−Removed: Agenus' subsidiary MiNK completed a successful Initial Public Offering in October 2021 and is publicly traded on Nasdaq under the symbol INKT.
−Removed: MiNK is a clinical-stage precision oncology company developing unmodified and engineered invariant natural killer T cell therapies for cancer and other immune-mediated diseases.
+Added: Agenus' subsidiary MiNK completed an initial public offering in October 2021 and is publicly traded on Nasdaq under the symbol INKT.
+Added: MiNK is a clinical-stage precision oncology company developing unmodified and engineered INKT cell therapies for cancer and other immune-mediated diseases.
Their lead product candidate, agenT-797, is an off-the-shelf, allogeneic, native iNKT cell therapy.
5 unchanged sentences
Historical Results of Operations
−Removed: Three months ended June 30, 2023 compared to the three months ended June 30, 2022
+Added: Three months ended September 30, 2023 compared to the three months ended September 30, 2022
Research and development revenue
−Removed: We recognized research and development revenue of approximately $2.5 million and $1.9 million during the three months ended June 30, 2023 and 2022, respectively.
−Removed: Research and development revenues in the second quarter of 2023 primarily consisted of $2.0 million related to the recognition of deferred revenue earned under our Gilead Collaboration Agreements.
−Removed: Research and development revenues in the second quarter of 2022 primarily consisted of $1.2 million related to the recognition of deferred revenue earned under our Gilead Collaboration Agreements.
+Added: We recognized research and development revenue of approximately $3.4 million and $4.6 million during the three months ended September 30, 2023 and 2022, respectively.
+Added: Research and development revenues in the third quarter of 2023 primarily consisted of $2.9 million related to the recognition of deferred revenue earned under our Gilead Collaboration Agreements.
+Added: Research and development revenues in the third quarter of 2022 primarily consisted of $4.5 million related to the recognition of deferred revenue earned under our Gilead Collaboration Agreements.
Non-cash royalty revenue related to the sale of future royalties
2 unchanged sentences
As a result of this liability accounting, even though the royalties are remitted directly to HCR, we record these royalties from GSK as revenue.
−Removed: Non-cash royalty revenue related to our agreement with GSK increased $22.0 million, to approximately $22.1 million for the three months ended June 30, 2023, from $0.1 million for the three months ended June 30, 2022, mainly due to the achievement of the final sales milestone under the HCR agreement and the recognition of these royalties as royalty milestone revenue in the three months ended June 30, 2022.
+Added: Non-cash royalty revenue related to our agreement with GSK increased $11.1 million, to approximately $20.4 million for the three months ended September 30, 2023, from $9.2 million for the three months ended September 30, 2022, due to increased net sales of GSK’s vaccines containing our QS-21 STIMULON adjuvant and the achievement of the final sales milestone under the HCR agreement and the recognition of $7.9 million of these royalties as royalty milestone revenue in the three months ended September 30, 2022.
Research and development expense
Research and development expense includes the costs associated with our internal research and development activities, including compensation and benefits, occupancy costs, manufacturing costs, costs of consultants, and administrative costs.
−Removed: Research and development expense increased 32% to $59.3 million for the three months ended June 30, 2023 from $45.0 million for the three months ended June 30, 2022.
−Removed: Increased expenses in the three months ended June 30, 2023 primarily relate to a $10.5 million increase in third-party services and other expenses, largely due to the timing of expenses related to the advancement of our antibody programs,
−Removed: a $2.1 million increase in personnel related expenses, primarily due to increased headcount, a $1.2 million increase in expenses attributable to the activities of our subsidiaries and a $0.5 million increase in other research and development expenses.
+Added: Research and development expense increased 12% to $51.4 million for the three months ended September 30, 2023 from $46.0 million for the three months ended September 30, 2022.
+Added: Increased expenses in the three months ended September 30, 2023 primarily relate to a $5.8 million increase in third-party services and other expenses, largely due to the timing of expenses related to the advancement of our antibody programs, a $1.7 million increase in personnel related expenses, and a $1.4 million increase in other research and development expenses.
+Added: These increases were partially offset by a $3.5 million decrease in expenses attributable to the activities of our subsidiaries.
General and administrative expense
General and administrative expense consists primarily of personnel costs, facility expenses, and professional fees.
−Removed: General and administrative expenses increased 8% to $20.4 million for the three months ended June 30, 2023 from $18.9 million for the three months ended June 30, 2022.
−Removed: Increased expenses in the three months ended June 30, 2023 primarily relate to a $2.0 million increase in personnel related expenses, largely due to increased headcount, and a $0.2 million increase in other general and administrative expenses.
−Removed: These increases were partially offset $0.6 million decrease in expenses attributable to the activities of our subsidiaries.
−Removed: Non-operating income (expense)
−Removed: Non-operating expense increased $9.3 million for the three months ended June 30, 2023, from income of $9.1 million for the three months ended June 30, 2022 to expense of $0.2 million for the three months ended June 30, 2023, primarily due to de minimis activity in the three months ended June 30, 2023, compared to the recognition of a $6.6 million gain on the sale of property, plant and equipment and a $2.8 million gain on the partial forgiveness of a liability in the three months ended June 30, 2022.
+Added: General and administrative expenses increased 4% to $18.9 million for the three months ended September 30, 2023 from $18.1 million for the three months ended September 30, 2022.
+Added: Increased expenses in the three months ended September 30, 2023 primarily relate to a $1.8 million increase in personnel related expenses, and a $0.4 million increase in other general and administrative expenses.
+Added: These increases were partially offset by a $0.8 million decrease in professional fees and a $0.7 million decrease in expenses attributable to the activities of our subsidiaries.
Interest expense, net
−Removed: Interest expense, net increased to approximately $18.5 million for the three months ended June 30, 2023 from $13.7 million for the three months ended June 30, 2022, mainly due to increased non-cash interest recorded in connection with our Royalty Purchase Agreement with HCR and increased interest expense recorded in connection with our finance leases, partially offset by increased interest income earned on our cash equivalents and short-term investments.
−Removed: Six months ended June 30, 2023 compared to the six months ended June 30, 2022
+Added: Interest expense, net increased to approximately $18.6 million for the three months ended September 30, 2023 from $15.6 million for the three months ended September 30, 2022, mainly due to increased non-cash interest recorded in connection with our Royalty Purchase Agreement with HCR and increased interest expense recorded in connection with our finance leases, partially offset by increased interest income earned on our cash equivalents and short-term investments.
+Added: Nine months ended September 30, 2023 compared to the nine months ended September 30, 2022
Research and development revenue
−Removed: We recognized research and development revenue of approximately $5.1 million and $8.6 million during the six months ended June 30, 2023 and 2022, respectively.
−Removed: Research and development revenues in the first half of 2023 primarily consisted of $4.4 million related to the recognition of deferred revenue earned under our Gilead Collaboration Agreements.
−Removed: Research and development revenues in the first half of 2022 primarily consisted of a $5.0 million milestone and $2.6 million related to the recognition of deferred revenue, both earned under our Gilead Collaboration Agreements.
+Added: We recognized research and development revenue of approximately $8.5 million and $13.2 million during the nine months ended September 30, 2023 and 2022, respectively.
+Added: Research and development revenues in the first nine months of 2023 primarily consisted of $7.2 million related to the recognition of deferred revenue earned under our Gilead Collaboration Agreements.
+Added: Research and development revenues in the first nine months of 2022 primarily consisted of a $5.0 million milestone and $7.1 million related to the recognition of deferred revenue, both earned under our Gilead Collaboration Agreements.
Non-cash royalty revenue related to the sale of future royalties
2 unchanged sentences
As a result of this liability accounting, even though the royalties are remitted directly to HCR, we record these royalties from GSK as revenue.
−Removed: Non-cash royalty revenue related to our agreement with GSK increased $23.4 million, to approximately $41.2 million for the six months ended June 30, 2023, from $17.8 million for the six months ended June 30, 2022, due to increased net sales of GSK’s vaccines containing our QS-21 STIMULON adjuvant and the achievement of the final sales milestone under the HCR agreement and the recognition of these royalties as royalty milestone revenue in the six months ended June 30, 2022.
+Added: Non-cash royalty revenue related to our agreement with GSK increased $34.5 million, to approximately $61.5 million for the nine months ended September 30, 2023, from $27.0 million for the nine months ended September 30, 2022, due to increased net sales of GSK’s vaccines containing our QS-21 STIMULON adjuvant and the achievement of the final sales milestone under the HCR agreement and the recognition of approximately $25.3 million of these royalties as royalty milestone revenue in the nine months ended September 30, 2022.
Research and development expense
Research and development expense includes the costs associated with our internal research and development activities, including compensation and benefits, occupancy costs, manufacturing costs, costs of consultants, and administrative costs.
−Removed: Research and development expense increased 33% to $116.4 million for the six months ended June 30, 2023 from $87.4 million for the six months ended June 30, 2022.
−Removed: Increased expenses in the six months ended June 30, 2023 primarily relate to a $21.8 million increase in third-party services and other expenses, largely due to the timing of expenses related to the advancement of our antibody programs, a $3.5 million increase in personnel related expenses, primarily due to increased headcount, a $2.6 million increase in expenses attributable to the activities of our subsidiaries and a $1.0 million increase in other research and development expenses.
+Added: Research and development expense increased 26% to $167.8 million for the nine months ended September 30, 2023 from $133.4 million for the nine months ended September 30, 2022.
+Added: Increased expenses in the nine months ended September 30, 2023 primarily relate to a $27.6
+Added: million increase in third-party services and other expenses, largely due to the timing of expenses related to the advancement of our antibody programs, a $5.3 million increase in personnel related expenses, primarily due to increased headcount, and a $2.4 million increase in other research and development expenses.
+Added: These increases were partially offset by a $0.9 million decrease in expenses attributable to the activities of our subsidiaries.
General and administrative expense
General and administrative expense consists primarily of personnel costs, facility expenses, and professional fees.
−Removed: General and administrative expenses increased 2% to $38.7 million for the six months ended June 30, 2023 from $37.9 million for the six months ended June 30, 2022.
−Removed: Increased expenses in the six months ended June 30, 2023 primarily relate to a $2.0 million increase in personnel related expenses, largely due to increased headcount, and a $0.8 million increase in other general and administrative expenses.
+Added: General and administrative expenses increased 3% to $57.6 million for the nine months ended September 30, 2023 from $56.0 million for the nine months ended September 30, 2022.
+Added: Increased expenses in the nine months ended September 30, 2023 primarily relate to a $3.8 million increase in personnel related expenses, largely due to increased headcount, and a $1.2 million increase in other general and administrative expenses.
These increases were partially offset by a $2.0 million decrease in professional fees, primarily due to reduced consulting and external legal costs, and a $1.5 million decrease in expenses attributable to the activities of our subsidiaries.
Non-operating income (expense)
−Removed: Non-operating expense increased $9.3 million for the six months ended June 30, 2023, from income of $9.1 million for the six months ended June 30, 2022 to expense of $0.2 million for the six months ended June 30, 2023, primarily due to de minimis activity in the six months ended June 30, 2023, compared to the recognition of a $6.6 million gain on the sale of property, plant and equipment and a $2.8 million gain on the partial forgiveness of a liability in the six months ended June 30, 2022.
+Added: Non-operating income (expense) includes our foreign currency translation adjustment and other income or expense.
+Added: Non-operating income decreased $9.4 million for the nine months ended September 30, 2023, from income of $9.7 million for the nine months ended September 30, 2022 to income of $0.2 million for the nine months ended September 30, 2023, primarily due to de minimis activity in the nine months ended September 30, 2023, compared to the recognition of a $6.6 million gain on the sale of property, plant and equipment and a $2.8 million gain on the partial forgiveness of a liability in the nine months ended September 30, 2022.
Interest expense, net
−Removed: Interest expense, net increased to approximately $35.1 million for the six months ended June 30, 2023 from $28.9 million for the six months ended June 30, 2022, mainly due to increased non-cash interest recorded in connection with our Royalty Purchase Agreement with HCR and increased interest expense recorded in connection with our finance leases, partially offset by increased interest income earned on our cash equivalents and short-term investments.
+Added: Interest expense, net increased to approximately $53.7 million for the nine months ended September 30, 2023 from $44.5 million for the nine months ended September 30, 2022, mainly due to increased non-cash interest recorded in connection with our Royalty Purchase Agreement with HCR and increased interest expense recorded in connection with our finance leases, partially offset by increased interest income earned on our cash equivalents and short-term investments.
Research and Development Programs
−Removed: For the six months ended June 30, 2023, our research and development programs consisted largely of our antibody programs as indicated in the following table (in thousands).
−Removed: Six Months Ended June 30,
+Added: For the nine months ended September 30, 2023, our research and development programs consisted largely of our antibody programs as indicated in the following table (in thousands).
+Added: Nine Months Ended September 30,
Year Ended December 31,
2 unchanged sentences
Vaccine adjuvant
−Removed: QS-21 STIMULON
+Added: STIMULON cpc QS-21
Cell therapies
7 unchanged sentences
Liquidity and Capital Resources
−Removed: We have incurred annual operating losses since inception, and we had an accumulated deficit of $1.8 billion as of June 30, 2023.
−Removed: We expect to incur significant losses over the next several years as we continue development of our technologies and product candidates, manage our regulatory processes, initiate and continue clinical trials, and prepare for potential commercialization of products.
+Added: We have incurred annual operating losses since inception, and we had an accumulated deficit of $1.9 billion as of September 30, 2023.
+Added: We expect to incur significant losses over the next several years as we continue development of our technologies and product
+Added: candidates, manage our regulatory processes, initiate and continue clinical trials, and prepare for potential commercialization of products.
To date, we have financed our operations primarily through corporate partnerships, advance royalty sales and the issuance of equity.
−Removed: From our inception through June 30, 2023, we have raised aggregate net proceeds of approximately $1.8 billion through the sale of common and preferred stock, the exercise of stock options and warrants, proceeds from our Employee Stock Purchase Plan, royalty monetization transactions, and the issuance of convertible and other notes.
+Added: From our inception through September 30, 2023, we have raised aggregate net proceeds of approximately $1.9 billion through the sale of common and preferred stock, the exercise of stock options and warrants, proceeds from our Employee Stock Purchase Plan, royalty monetization transactions, and the issuance of convertible and other notes.
We maintain an effective registration statement (the “Registration Statement”), covering common stock, preferred stock, warrants, debt securities and units.
3 unchanged sentences
as our sales agent.
−Removed: We sold approximately 58.3 million and 13.2 million shares of our common stock pursuant to the Sales Agreement during the six months ended June 30, 2023 and the period of July 1, 2023 through August 4, 2023, respectively, for aggregate net proceeds totaling $123.1 million.
−Removed: As of August 4, 2023, approximately 171.4 million shares remained available for sale under the Sales Agreement.
+Added: We sold approximately 71.6 million shares of our common stock pursuant to the Sales Agreement during the nine months ended September 30, 2023, for aggregate net proceeds totaling $123.2 million.
+Added: As of September 30, 2023, approximately 171.3 million shares remained available for sale under the Sales Agreement.
We have funded our operations largely from cash received from partners, royalty financing transactions and equity offerings.
−Removed: We transact at-the-market sales from time to time in order to manage our cash balances to make sure cash balances do not drop below
−Removed: a certain level based on our anticipated uses of cash.
+Added: We transact at-the-market sales from time to time in order to manage our cash balances to make sure cash balances do not drop below a certain level based on our anticipated uses of cash.
We execute at-the-market offerings based on market conditions and our stock price.
We do not have in place a program whereby at-the-market offerings are executed automatically based on our trading volume.
−Removed: As of June 30, 2023, we had debt outstanding of $13.6 million in principal.
+Added: As of September 30, 2023, we had debt outstanding of $13.4 million in principal.
In November 2022, we amended all of the outstanding 2015 Subordinated Notes, extending the due date by two years to February 2025.
−Removed: Our cash, cash equivalents and short-term investments at June 30, 2023 were $157.9 million, a decrease of $35.5 million from December 31, 2022.
−Removed: Cash and cash equivalents of our subsidiary, MiNK, at March 31, 2023, were $14.9 million.
+Added: Our cash, cash equivalents and short-term investments at September 30, 2023 were $106.3 million, a decrease of $87.1 million from December 31, 2022.
+Added: Cash and cash equivalents of our subsidiary, MiNK, at June 30, 2023, were $10.6 million.
MiNK cash can only be accessed by Agenus through a declaration of a dividend by the MiNK Board of Directors or through settlement of intercompany balances.
−Removed: Based on our current plans and projections, we believe our cash resources of $157.9 million as of June 30, 2023, will be sufficient to satisfy our liquidity needs for more than one year from when these financial statements were issued.
−Removed: Management consistently monitors our liquidity position and has the flexibility to adjust spending as necessary to preserve and extend liquidity.
−Removed: We regularly assess the likelihood of success of our programs, and our funding decisions are based on these evaluations.
−Removed: We are prepared to discontinue funding of any activities that do not impact our core priorities and to restrict capital expenditures and/or reduce the scale of our operations.
−Removed: Potential funding sources may include collaborations, out-licensing and/or partnering opportunities for our portfolio programs and product candidates with multiple parties, milestone payments from our existing partnerships, additional third-party agreements, asset sales, project financing, and/or sales of equity securities.
+Added: Based on our current plans and projections, we believe that our cash resources of $106.3 million as of September 30, 2023, plus additional funding we anticipate from the achievement of a milestone under an existing partnership, will be sufficient to satisfy our liquidity requirements for at least one year from when these financial statements were issued.
+Added: This milestone will be triggered upon dosing the first patient in a clinical trial which is currently screening patients and is expected to occur by end of 2023.
+Added: However, until this event occurs, in accordance with the relevant accounting guidance we are required to disclose that substantial doubt exists about our ability to continue as a going concern for a period of one year after the date of filing of this Quarterly Report on Form 10-Q.
+Added: In addition to the expected milestone payment by end of 2023, we are in active discussions to sell two non-strategic assets expected to close in the first half of 2024 with an estimated aggregate value of approximately $65.0 million.
+Added: These transactions could extend our cash resources well beyond 2024.
+Added: We are also in advanced discussions for a potential structured financing for botensilimab/balstilimab, as well as a potential corporate collaboration with a large pharma or biotech company.
+Added: None of these sources of cash involve equity or debt issuance.
+Added: Management continues to address the Company’s liquidity position and has the flexibility to adjust spending as needed in order to preserve liquidity.
+Added: In August 2023, we prioritized and focused our resources to accelerate the development, registration, and commercialization of our lead asset postponing all preclinical and other clinical programs and reducing our workforce by approximately 25%.
+Added: Garo Armen has elected to receive his base salary and any potential bonus payments in stock rather than cash.
+Added: We continuously evaluate the likelihood of success of our programs.
+Added: As such, our decisions to continue to fund or eliminate funding of each of our programs are predicated on these determinations, on an ongoing basis.
+Added: We expect our sources of funding to include payments from current collaborations which include milestones and royalty payments from companies, including BMS, UroGen, Gilead, Incyte, and Merck;
+Added: out-licensing and/or partnering opportunities for our portfolio programs and product candidates with multiple parties;
+Added: additional third-party agreements;
+Added: royalty monetization;
+Added: project financing, and/or sales of equity securities.
Our future cash requirements include, but are not limited to, supporting clinical trial and regulatory efforts and continuing our other research and development programs.
1 unchanged sentence
Under these agreements, subject to the enrollment of patients and performance by the applicable third-party provider, we have estimated our total payments to be $601.3 million over the term of the related activities.
−Removed: Through June 30, 2023, we have expensed $500.9 million as research and development expenses and $480.6 million has been paid under these agreements.
−Removed: The timing of expense recognition and future payments related to these agreements is subject to the enrollment of patients and performance by the applicable third-party provider.
+Added: Through September 30, 2023, we have expensed $519.8 million as research and development expenses and $500.7 million has been paid under these agreements.
+Added: The timing of expense recognition and future payments related to these agreements is subject to the
+Added: enrollment of patients and performance by the applicable third-party provider.
We plan to enter into additional agreements with third party providers and we anticipate significant additional expenditures will be required to initiate and advance our various programs.
2 unchanged sentences
For example, our collaboration with Incyte for the development, manufacture and commercialization of CPM antibodies against certain targets is managed by a joint steering committee, which is controlled by Incyte.
−Removed: Net cash used in operating activities for the six months ended June 30, 2023 and 2022 was $118.6 million and $95.8 million, respectively.
+Added: Net cash used in operating activities for the nine months ended September 30, 2023 and 2022 was $183.8 million and $128.0 million, respectively.
Our future ability to generate cash from operations will depend on achieving regulatory approval and market acceptance of our product candidates, achieving benchmarks as defined in existing collaboration agreements, and our ability to enter into new collaborations.
2 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.