5 unchanged sentences
Cash and cash equivalents
+Added: Accounts receivable, net
+Added: Inventory, net
Prepaid expenses and other current assets
7 unchanged sentences
Accrued expenses
+Added: Deferred revenue
Operating lease liabilities, current
8 unchanged sentences
10,000,000 shares
−Removed: authorized and no shares issued and outstanding at March 31, 2024
+Added: authorized and no shares issued and outstanding at June 30, 2024
and December 31, 2023
1 unchanged sentence
1,000,000,000 shares authorized,
−Removed: 119,221,230 shares issued and outstanding at March 31, 2024;
+Added: 119,442,635 shares issued and outstanding at June 30, 2024;
110,160,684 shares issued and outstanding at December 31, 2023
8 unchanged sentences
(In thousands, except share and per share amounts)
−Removed: Three Months Ended March 31,
−Removed: Three Months Ended March 31,
−Removed: Operating expenses:
+Added: Three Months Ended June 30,
+Added: Three Months Ended June 30,
+Added: Six Months Ended June 30,
+Added: Six Months Ended June 30,
+Added: Product revenue, net
+Added: Total revenue
+Added: Operating costs and expenses:
+Added: Cost of product revenue
Research and development (1)
1 unchanged sentence
Selling, general and administrative
−Removed: Total operating expenses
+Added: Total operating costs and expenses
Loss from operations
7 unchanged sentences
Weighted-average common shares outstanding, basic and diluted
−Removed: (1) Includes related-party amounts of $ 1,135 and $ 2,960 for the three months ended March 31, 2024 and 2023, respectively (see Note 14).
−Removed: (2) Includes related-party amounts of $ 0 and $ 375 for the three months ended March 31, 2024 and 2023, respectively (see Note 14).
+Added: (1) Includes related-party amounts of $ 1,131 and $ 2,266 for the three and six months ended June 30, 2024 , respectively, and $ 2,258 and $ 5,218 for the three and six months ended June 30, 2023, respectively (see Note 15).
+Added: (2) Includes no related-party amounts for both the three and six months ended June 30, 2024 , and $ 0 and $ 375 for the three and six months ended June 30, 2023, respectively (see Note 15).
The accompanying notes are an integral part of these condensed consolidated financial statements.
19 unchanged sentences
Balances at March 31, 2023
+Added: Vesting of restricted common stock
+Added: from early-exercised options
+Added: Exercise of stock options
+Added: Repurchase of unvested restricted
+Added: Retirement of treasury stock
+Added: Stock-based compensation expense
+Added: Issuance of common stock under the
+Added: employee stock purchase plan
+Added: Unrealized gain on available-for-sale
+Added: securities, net of tax
+Added: Balances at June 30, 2023
Treasury Stock
12 unchanged sentences
Balances at March 31, 2024
+Added: Stock-based compensation expense
+Added: Exercise of stock options
+Added: Issuance of common stock under the
+Added: employee stock purchase plan
+Added: Balances at June 30, 2024
The accompanying notes are an integral part of these condensed consolidated financial statements.
2 unchanged sentences
(In thousands)
−Removed: Three Months Ended March 31,
−Removed: Three Months Ended March 31,
+Added: Six Months Ended June 30,
+Added: Six Months Ended June 30,
Cash flows from operating activities:
5 unchanged sentences
Changes in operating assets and liabilities:
+Added: Accounts receivable
Prepaid expenses and other current assets
2 unchanged sentences
Accrued expenses
+Added: Deferred revenue
Operating lease liabilities
3 unchanged sentences
Cash flows from investing activities:
+Added: Purchases of marketable securities
Maturities of marketable securities
6 unchanged sentences
Payments for offering costs
+Added: Payments for repurchases of unvested restricted common stock
Net cash provided by financing activities
2 unchanged sentences
Cash and cash equivalents at end of period
−Removed: Supplemental disclosure of cash flow information
−Removed: Deferred offering costs in accrued expenses
The accompanying notes are an integral part of these condensed consolidated financial statements.
5 unchanged sentences
The Company’s proprietary INVYMAB platform approach combines state-of-the-art viral surveillance and predictive modeling with advanced antibody engineering.
−Removed: INVYMAB is designed to facilitate the rapid, serial generation of new monoclonal antibodies (“mAbs”) to address evolving viral threats.
+Added: INVYMAB is designed to facilitate the rapid, serial generation of new monoclonal antibodies (“mAbs”) to keep pace with evolving viral threats.
On March 22, 2024, the Company received emergency use authorization (“EUA”) from the U.S.
1 unchanged sentence
Recipients should not be currently infected with or have had a known recent exposure to an individual infected with SARS-CoV-2.
−Removed: In May 2024, the Company announced its intention to submit an EUA application to the FDA for pemivibart for the treatment of mild to moderate symptomatic COVID-19 in certain immunocompromised people utilizing a rapid immunobridging pathway, which was aligned in principle with the FDA and would leverage a similar approach as the Company used to achieve its current EUA for PEMGARDA for pre-exposure prophylaxis of COVID-19 in certain immunocompromised people.
−Removed: The immunobridging pathway for COVID-19 treatment is enabled by data from the Company’s previous Phase 2/3 clinical trial (STAMP) of adintrevimab, the prototype mAb, for the treatment of COVID-19 and data from the Company’s ongoing CANOPY Phase 3 clinical trial of VYD222 (pemivibart) for pre-exposure prophylaxis of COVID-19.
−Removed: The potential COVID-19 treatment EUA request would focus on the critical treatment needs of people in the U.S.
+Added: In July 2024, the Company submitted a request to the FDA to amend the EUA for PEMGARDA, for the treatment of mild-to-moderate symptomatic COVID-19 in certain immunocompromised patients.
+Added: The submission utilizes a rapid immunobridging pathway previously aligned in principle with the FDA.
+Added: The EUA amendment request is based on positive immunobridging analyses of pemivibart versus comparator mAbs and data from the Company’s ongoing CANOPY Phase 3 clinical trial in participants with moderate-to-severe immune compromise.
+Added: The COVID-19 treatment EUA request focuses on the critical treatment needs of people in the U.S.
who have moderate-to-severe immune compromise and for whom alternative COVID-19 treatment options are not clinically appropriate or accessible.
−Removed: Subsequent to the anticipated submission of an EUA request, the Company plans to initiate a compact clinical trial focused on confirmatory safety, pharmacokinetics, and clinical virology.
PEMGARDA is the Company’s first mAb in a planned series of innovative mAb candidates designed to keep pace with SARS-CoV-2 viral evolution.
As the SARS-CoV-2 virus evolves over time, the Company anticipates leveraging its INVYMAB platform approach to periodically introduce new or engineered mAb candidates, an approach that would be analogous to the periodic updates made to influenza and COVID-19 vaccines.
−Removed: In January 2024, the Company nominated VYD2311, a mAb optimized for neutralization potency against recent SARS-CoV-2 lineages such as BA.2.86 and JN.1, as a drug candidate, and the Company expects it will be the next pipeline program to advance into clinical development.
+Added: In January 2024, the Company nominated VYD2311, a mAb optimized for neutralization potency against prominent SARS-CoV-2 variants, as a drug candidate, and the Company expects it will be the next pipeline program to advance into clinical development.
+Added: In May 2024, the Company announced general alignment with the FDA on an expedient, repeatable immunobridging pathway to future potential EUAs for serial, novel mAbs for the prevention and treatment of symptomatic COVID-19.
+Added: This pathway provides the company with the opportunity to rapidly, efficiently, and durably deliver high value medicines that prevent and treat symptomatic COVID-19 in vulnerable populations.
In addition to developing candidates for COVID-19, the Company expects to apply its INVYMAB platform approach to produce lead molecules for other viral diseases, such as influenza.
6 unchanged sentences
The Company is subject to a number of risks and uncertainties common to companies in the biopharmaceutical industry, including, but not limited to, completing clinical trials, the ability to raise additional capital to fund operations, obtaining regulatory authorization or approval for product candidates, risks associated with market acceptance and commercialization of products, competition from other products, protection of proprietary intellectual property, compliance with government regulations, dependence on key personnel, the ability to attract and retain qualified employees, and reliance on third-party organizations for the discovery, manufacturing, clinical and commercial success of its product candidates.
−Removed: Through March 31, 2024, the Company had not generated any revenue.
To date, the Company has received regulatory authorization for only one product candidate, PEMGARDA, which has not been approved, but has been authorized for emergency use by the FDA under an EUA, for pre-exposure prophylaxis of COVID-19 in certain adults and adolescent individuals (12 years of age and older weighing at least 40 kg).
−Removed: Beyond VYD222 (pemivibart), all of the Company’s other product candidates, other than adintrevimab, are currently in preclinical development.
+Added: Beyond VYD222 (pemivibart) and VYD2311, all of the Company’s other product candidates, other than adintrevimab, are currently in preclinical development.
The Company’s additional product candidates require significant additional research and development efforts, including extensive clinical testing, and regulatory authorization or approval prior to potential commercialization.
3 unchanged sentences
The accompanying condensed consolidated financial statements have been prepared on the basis of continuity of operations, realization of assets, and the satisfaction of liabilities and commitments in the ordinary course of business.
−Removed: The Company has primarily funded its operations with proceeds from sales of convertible preferred stock, proceeds from the Company’s initial public offering (“IPO”) and net proceeds received from shares of common stock solder under the Sales Agreement (defined below).
+Added: The Company has primarily funded its operations with proceeds from sales of convertible preferred stock, proceeds from the Company’s initial public offering (“IPO”) and net proceeds received from shares of common stock sold under the Sales Agreement (as defined below).
In February 2024, the Company sold 9,000,000 shares of its common stock under the Sales Agreement at an average price of $ 4.50 per share for $ 39.3 million in net proceeds.
−Removed: The Company has incurred losses and negative cash flows from operations since its inception, including a net loss of $ 43.5 million for the three months ended March 31, 2024.
−Removed: As of March 31, 2024, the Company had an accumulated deficit of $ 775.6 million.
+Added: After receiving EUA in March 2024, the Company has also funded its operations from sales of PEMGARDA.
+Added: The Company has incurred losses and negative cash flows from operations since its inception, including a net loss of $ 90.7 million for the six months ended June 30, 2024.
+Added: As of June 30, 2024, the Company had an accumulated deficit of $ 822.8 million.
The Company may continue to generate operating losses for the foreseeable future.
−Removed: Based on current operating plans and excluding any contribution from revenues or external financing, the Company will not have sufficient cash and cash equivalents to fund its operating expenses and capital requirements beyond one year from the issuance of these condensed consolidated financial statements, and therefore, the Company has concluded that there is substantial doubt about its ability to continue as a going concern.
+Added: Based on current operating plans and excluding any contribution from future revenues or external financing, the Company will not have sufficient cash and cash equivalents to fund its operating expenses and capital requirements beyond one year from the issuance of these condensed consolidated financial statements, and therefore, the Company has concluded that there is substantial doubt about its ability to continue as a going concern.
The Company will require additional funding through a combination of contribution from revenues, equity offerings, government or private-party grants, debt financings or other capital sources, such as collaborations with other companies, strategic alliances or licensing arrangements to finance its future operations.
12 unchanged sentences
Summary of Significant Accounting Policies
−Removed: As of March 31, 2024, the Company’s significant accounting policies and estimates, which are detailed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the U.S.
+Added: As of June 30, 2024, the Company’s significant accounting policies and estimates, which are detailed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the U.S.
Securities and Exchange Commission (“SEC”) on March 28, 2024 (the “2023 Form 10-K”) have not changed, except as discussed below.
5 unchanged sentences
The Company periodically reviews inventory levels to identify what may expire prior to expected sale or has a cost basis in excess of its estimated realizable value and writes-down such inventories as appropriate as a component of costs of goods sold in the consolidated statements of operations and comprehensive loss .
+Added: Concentrations of Credit Risk, Significant Suppliers and License Rights
+Added: Financial instruments that potentially expose the Company to concentrations of credit risk consist of cash, cash equivalents and accounts receivable.
+Added: As of June 30, 2024, the Company invested its excess cash in money market funds that are subject to minimal credit and market risks.
+Added: The Company maintains its existing cash and cash equivalents at three accredited financial institutions that it believes are creditworthy.
+Added: From time to time, these deposits may exceed federally insured limits.
+Added: The Company has not experienced any losses historically in these accounts.
+Added: Accordingly, the Company does not believe it is exposed to unusual credit risk related to its existing cash and cash equivalents beyond the normal credit risk associated with commercial banking relationships.
+Added: As of June 30, 2024, the Company had one third-party logistics distribution agent under the temporary title model which accounted for all of the Company’s net product revenue (see “Revenue Recognition” for additional information).
+Added: The Company is dependent on third-party organizations to manufacture and process its product candidates for its research and development programs.
+Added: In particular, the Company relies on a single third-party contract manufacturer to produce and process its product candidates and to manufacture supply of its product candidates for preclinical and clinical activities.
+Added: The Company also currently relies on this same third-party contract manufacturer for any anticipated requirements of commercial supply, including both drug substance and drug product (see Note 9).
+Added: The Company expects to continue to be dependent on a small number of third-party organizations to supply it with its requirements for all product candidates.
+Added: The Company’s research and development programs, including any associated commercialization efforts, could be adversely affected by a significant interruption in the supply of the necessary materials.
+Added: The Company is dependent on a limited number of third parties that provide license rights used by the Company in the development and commercialization of its product candidates and programs.
+Added: Through June 30, 2024 , the Company’s research and development programs primarily relate to rights conveyed by Adimab (see Note 7).
+Added: The Company could experience delays in the development and commercialization of its product candidates and programs if the Adimab agreements or any other license agreement utilized in the Company’s research and development activities is terminated, if the Company fails to meet the obligations required under its arrangements, or if the Company is unable to successfully secure new strategic alliances or licensing agreements.
+Added: Accounts Receivable
+Added: Accounts receivable as of June 30, 2024 is comprised of $ 2.9 million of PEMGARDA product sales to the Title Company (as defined below) (see “Revenue Recognition” for additional information).
+Added: Revenue Recognition
+Added: The Company recognizes revenue in accordance with ASC Topic 606 - Revenue from Contracts with Customers (“ASC 606”).
+Added: Under ASC 606, an entity recognizes revenue when or as performance obligations are satisfied by transferring control of promised goods or services to the customer, in an amount that reflects the consideration which the entity expects to be entitled to in exchange for those goods or services.
+Added: To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the entity performs the following five steps:
+Added: (i) identify the contract(s) with a customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations in the contract, and (v) recognize revenue when (or as) the entity satisfies a performance obligation.
+Added: At contract inception, the Company assesses the goods or services promised within each contract, determines those that are performance obligations, and assesses whether each promised good or service is distinct.
+Added: The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.
+Added: Product Revenue, Net
+Added: Following EUA from the FDA in March 2024, the Company began generating product revenue from sales of PEMGARDA in April 2024.
+Added: The Company entered into a third-party logistics distribution agreement (the “3PL Agreement”) to engage a logistics distribution agent (the “3PL Agent”) to distribute the Company’s products to its customers.
+Added: The 3PL Agent provides services to the Company that include storage, distribution, processing product returns, customer service support, logistics support, electronic data interface and system access support.
+Added: Revenue is recognized when or as performance obligations are satisfied by transferring control of promised goods to a customer.
+Added: To date, the Company applied for mandatory distribution licenses that some states require in order for the Company to sell its product throughout the U.S.
+Added: In order for the Company to execute sales in the U.S.
+Added: prior to obtaining such licenses, the Company and an affiliate of the 3PL Agent (the “Title Company”) entered into a Temporary Title Model Agreement (the “Temporary Title Model Agreement”), which was an amendment to the 3PL Agreement, so that the Title Company may purchase and take title to the product and sell the product to the specialty distributors who have contracted to purchase the product from the Company.
+Added: Although under the Temporary Title Model Agreement, the Title Company takes title to the product, the economic substance of the transaction provides that the Title Company does not possess the risk of loss or participate in the significant risks and rewards of ownership of the product
+Added: or have the ability to control, direct the use of, and obtain substantially all of the remaining benefits from the product.
+Added: Accordingly, the Company does not recognize revenue upon the transfer of the goods at the time of sale to the Title Company and recognizes revenue when the goods are sold from the Title Company to the specialty distributors.
+Added: In July 2024, the Company obtained nearly all of the necessary state distribution licenses to sell its products throughout the U.S.
+Added: and, after a customary period of notice to the Title Company, intends to cease using the Temporary Title Model Agreement process in the third quarter of 2024.
+Added: Product revenues are recorded net of applicable reserves for variable consideration, including discounts and allowances.
+Added: Discounts and Allowances
+Added: The Company records reserves, based on contractual terms, for the following components of variable consideration related to product sold during the reporting period, as well as its estimate of product that remains in the distribution channel inventory of its customers at the end of the reporting period, if applicable.
+Added: On a quarterly basis, the Company updates its estimates, if necessary, and records any material adjustments in the period they are identified.
+Added: Trade Discounts and Distributor Fees
+Added: The Company provides customary discounts on PEMGARDA sales for prompt payment, the terms of which are explicitly stated in its contracts.
+Added: The Company also pays fees to specialty distributors for sales order management, data, and distribution services, the terms of which are also explicitly stated in its contracts.
+Added: Such fees are not for a distinct good or service and, accordingly, are recorded as a reduction of revenue, as well as a reduction to accounts receivable (trade discounts) or as a component of accrued expenses (distributor fees).
+Added: Government Chargebacks and Rebates
+Added: The Company is subject to discount obligations under its contract with the Department of Veterans Affairs.
+Added: These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability, which is included as a component of accrued expenses.
+Added: Product Returns
+Added: The Company offers a right of return for purchased units of PEMGARDA for damage, defect, recall, and/or product expiry, provided the product expiry is within a specified period as set forth in the Company’s return goods policy.
+Added: The Company estimates the amount of product sales that will be returned using quantitative and qualitative considerations.
+Added: Reserves for estimated returns are recorded as a reduction of product revenue in the period that the related revenue is recognized, as well as a component of accrued expenses.
+Added: Other Incentives
+Added: Other incentives include a co-pay assistance program for eligible patients with commercial insurance in the U.S.
+Added: The co-pay assistance program assists certain commercially insured patients by reducing each participating patient’s financial responsibility for the purchase price, up to a specified dollar amount of assistance.
Unaudited Interim Financial Information
−Removed: The accompanying condensed consolidated balance sheet as of March 31, 2024, the condensed consolidated statements of operations and comprehensive loss for the three months ended March 31, 2024 and 2023, the condensed consolidated statements of cash flows for the three months ended March 31, 2024 and 2023 and the condensed consolidated statements of stockholders’ equity (deficit) for the three months ended March 31, 2024 and 2023 are unaudited.
−Removed: The accompanying unaudited condensed consolidated financial statements as of March 31, 2024 and for the three months ended March 31, 2024 and 2023, have been prepared by the Company pursuant to the rules and regulations of the SEC for interim financial statements.
+Added: The accompanying condensed consolidated balance sheet as of June 30, 2024, the condensed consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2024 and 2023, the condensed consolidated statements of cash flows for the three and six months ended June 30, 2024 and 2023 and the condensed consolidated statements of stockholders’ equity (deficit) for the three and six months ended June 30, 2024 and 2023 are unaudited.
+Added: The accompanying unaudited condensed consolidated financial statements as of June 30, 2024 and for the three and six months ended June 30, 2024 and 2023, have been prepared by the Company pursuant to the rules and regulations of the SEC for interim financial statements.
The accompanying condensed consolidated balance sheet as of December 31, 2023 was derived from audited financial statements, but does not include all disclosures required by U.S.
2 unchanged sentences
These interim condensed consolidated financial statements should be read in conjunction with the Company’s audited annual consolidated financial statements, and the notes thereto, as of and for the year ended December 31, 2023, which are included in the 2023 Form 10-K.
−Removed: In the opinion of management, all adjustments, consisting only of normal recurring adjustments necessary for a fair statement of the Company’s condensed consolidated financial position as of March 31, 2024 and December 31, 2023, the condensed consolidated results of operations for the three months ended March 31, 2024 and 2023, the condensed consolidated cash flows for the three months ended March 31, 2024 and 2023 and changes in stockholders’ equity (deficit) for the three months ended March 31, 2024 and 2023 have been made.
−Removed: The Company’s condensed consolidated results of operations for the three months ended March 31, 2024 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2024 .
+Added: In the opinion of management, all adjustments, consisting only of normal recurring adjustments necessary for a fair statement of the Company’s condensed consolidated financial position as of June 30, 2024 and December 31, 2023, the condensed consolidated results of operations for the three and six months ended June 30, 2024 and 2023, the condensed consolidated cash flows for the three and six months ended June 30, 2024 and 2023 and changes in stockholders’ equity (deficit) for the three and six months ended June 30,
+Added: 2024 and 2023 have been made.
+Added: The Company’s condensed consolidated results of operations for the three and six months ended June 30, 2024 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2024 .
Use of Estimates
40 unchanged sentences
Fair Value Measurements at
−Removed: March 31, 2024:
+Added: June 30, 2024:
Cash equivalents:
5 unchanged sentences
The money market funds were valued by the Company based on quoted market prices, which represent a Level 1 measurement within the fair value hierarchy.
−Removed: There were no changes to the valuation methods during the three months ended March 31, 2024 or 2023.
+Added: There were no changes to the valuation methods during the three and six months ended June 30, 2024 or 2023.
The Company evaluates transfers between levels at the end of each reporting period.
−Removed: There were no transfers into or out of Level 1, Level 2 or Level 3 fair value measurements during the three months ended March 31, 2024 or 2023.
+Added: There were no transfers into or out of Level 1, Level 2 or Level 3 fair value measurements during the three and six months ended June 30, 2024 or 2023.
+Added: The following table presents inventories (in thousands):
+Added: Work in process
+Added: Finished goods
+Added: The Company did no t have any inventory as of December 31, 2023.
Prepaid Expenses and Other Current Assets
3 unchanged sentences
Prepaid compensation and other
+Added: Prepaid inventory
Interest receivable
4 unchanged sentences
Accrued employee compensation
+Added: Accrued inventory
License and Collaboration Agreements
12 unchanged sentences
Amounts paid with respect to services performed by Adimab on the Company’s behalf under the Adimab Assignment Agreement are recognized as research and development expense as such amounts are incurred.
−Removed: During both the three months ended March 31, 2024 and 2023 , the Company did no t recognize any research and development expense with respect to services performed by Adimab on the Company’s behalf under the Adimab Assignment Agreement.
+Added: During the three and six months ended June 30, 2024 and 2023 , the Company did no t recognize any research and development expense with respect to services performed by Adimab on the Company’s behalf under the Adimab Assignment Agreement.
Please refer to Note 15 for additional information.
The Company is obligated to pay Adimab up to $ 16.5 million upon the achievement of specified development and regulatory milestones for the first Product under the agreement that achieves such specified milestones and up to $ 8.1 million upon the achievement of specified development and regulatory milestones for the second Product under the agreement that achieves such specified milestones.
−Removed: The maximum aggregate amount of milestone payments payable under the agreement for any and all Products is $ 24.6 million , of which a total of $ 11.1 million has been achieved and paid as of March 31, 2024;
+Added: The maximum aggregate amount of milestone payments payable under the agreement for any and all Products is $ 24.6 million , of which a total of $ 11.1 million has been achieved and paid as of June 30, 2024;
however, milestone payments do not accrue for certain in vitro diagnostic devices consisting of or containing CoV Antibodies.
2 unchanged sentences
The next potential milestone under the Adimab Assignment Agreement is a low single-digit million-dollar regulatory milestone, which was not considered probable under U.S.
−Removed: GAAP and therefore, no expense was recognized as of March 31, 2024.
−Removed: During the three months ended March 31, 2024, the Company did no t recognize any in-process research and development (“IPR&D”) expense with respect to contingent consideration payable under the Adimab Assignment Agreement.
−Removed: During the three months ended March 31, 2023, the Company recognized $ 0.4 million of IPR&D expense with respect to contingent consideration payable under the Adimab Assignment Agreement.
+Added: GAAP and therefore, no expense was recognized as of June 30, 2024.
+Added: During both the three and six months ended June 30, 2024, the Company did no t recognize any in-process research and development (“IPR&D”) expense with respect to contingent consideration payable under the Adimab Assignment Agreement.
+Added: During the three and six months ended June 30, 2023, the Company recognized $ 0 and $ 0.4 million, respectively, of IPR&D expense with respect to contingent consideration payable under the Adimab Assignment Agreement.
The Company is obligated to pay Adimab royalties of a mid-single-digit percentage based on net sales of any Products, beginning upon the first commercial sale of a Product in accordance with the Adimab Assignment Agreement .
2 unchanged sentences
In addition, the Company is obligated to pay Adimab royalties of a specified percentage in the range of 45 % to 55 % of any compulsory sublicense consideration received by the Company in lieu of certain royalty payments.
−Removed: Except for milestone payments of $ 11.1 million incurred through December 31, 2023, no other milestone, royalty or other contingent payments had become due to Adimab through March 31, 2024.
+Added: Except for milestone payments of $ 11.1 million incurred through December 31, 2023, no other milestone, royalty or other contingent payments have been paid to or have been earned by Adimab through June 30, 2024.
Unless earlier terminated, the Adimab Assignment Agreement remains in effect until the expiration of the last-to-expire Royalty Term for any and all Products.
17 unchanged sentences
Effective January 2024, the Company became obligated to pay Adimab a quarterly fee of $ 0.6 million.
−Removed: During the three months ended March 31, 2024 and 2023, the Company recognized $ 0.6 million and $ 1.3 million, respectively, of research and development expense related to the quarterly fee.
+Added: During the three and six months ended June 30, 2024 the Company recognized $ 0.6 million and $ 1.2 million, respectively, of research and development expense related to the quarterly fee.
+Added: During the three and six months ended June 30, 2023 , the Company recognized $ 1.3 million and $ 2.6 million, respectively, of research and development expense related to the quarterly fee.
For each agreed upon research program that is commenced, the Company is obligated to pay Adimab quarterly for its services performed during a given research program at a specified full-time equivalent rate;
3 unchanged sentences
Amounts paid with respect to services performed by Adimab on the Company’s behalf in each of the research programs under the Adimab Collaboration Agreement are recognized as research and development expense as such amounts are incurred and services are rendered.
−Removed: During the three months ended March 31, 2024, the Company did no t recognize any research and development expense with respect to services performed by Adimab on the Company ’s behalf under the Adimab Collaboration Agreement.
−Removed: During the three months ended March 31, 2023 , the Company recognized $ 0.2 million of research and development expense with respect to services performed by Adimab on the Company’s behalf under the Adimab Collaboration Agreement.
−Removed: During both the three months ended March 31, 2024 and 2023, the Company did no t recognize any
−Removed: IPR&D expense related to drug delivery fees, optimization completion fees or option exercise fees.
+Added: During both the three and six months ended June 30, 2024, the Company did no t recognize any research and development expense with respect to services performed by Adimab on the Company ’s behalf under the Adimab Collaboration Agreement.
+Added: During the three and six months ended June 30, 2023 , the Company recognized $ 0.2 million and $ 0.4 million, respectively, of research and development expense with respect to services performed by Adimab on the Company’s behalf under the Adimab Collaboration Agreement.
+Added: During the three and six months ended June 30, 2024 and 2023, the Company did no t recognize any IPR&D expense related to drug delivery fees, optimization completion fees or option exercise fees.
Please refer to Note 15 for additional information.
1 unchanged sentence
The next potential milestone under the Adimab Collaboration Agreement is a low single-digit million-dollar clinical milestone, which was not considered probable under U.S.
−Removed: GAAP and therefore, no expense was recognized as of March 31, 2024.
+Added: GAAP and therefore, no expense was recognized as of June 30, 2024.
The Company is also obligated to pay Adimab royalties of a mid-single-digit percentage based on net sales of any product under the Adimab Collaboration Agreement, subject to reductions for third-party licenses.
−Removed: The royalty term will expire for each product on a country-by-country basis upon the later of (i) 12 years after the first commercial sale of such product in such country and (ii) the expiration of the last valid claim of any patent claiming composition of matter or method of making or using any antibody identified or optimized under the Adimab Collaboration Agreement in such country.
+Added: The royalty term will expire for each product on a country-by-country basis upon the later of (i) 12 years after the first commercial sale of such product in such country and (ii) the expiration of the last valid claim of any patent claiming composition
+Added: of matter or method of making or using any antibody identified or optimized under the Adimab Collaboration Agreement in such country.
In addition, the Company is obligated to pay Adimab for Adimab’s performance of certain validation work with respect to certain antigens acquired from a third party.
In consideration for this work, the Company is obligated to pay Adimab royalties of a low single-digit percentage based on net sales of products that contain such antigens for the same royalty term as antibody-based products, but the Company is not obligated to make any milestone payments for such antigen products.
−Removed: Through March 31, 2024, the Company had not paid any royalties to Adimab under the Adimab Collaboration Agreement.
+Added: Through June 30, 2024, no royalty payments have been paid to or have been earned by Adimab under the Adimab Collaboration Agreement.
The Adimab Collaboration Agreement will expire (i) if the Company does not exercise any option, upon the conclusion of the last Evaluation Term for the research programs, or (ii) if the Company exercises an option, on the expiration of the last royalty term for a product in a particular country, unless the agreement is earlier terminated.
13 unchanged sentences
The first annual fee became due in September 2023 and was paid in October 2023.
−Removed: During the three months ended March 31, 2024, the Company recognized a portion of the first annual fee as research and development expense.
+Added: During the three and six months ended June 30, 2024, the Company recognized a portion of the first annual fee as research and development expense.
Beginning in July 2027 and ending in June 2042, unless terminated earlier, the Company has the option to receive additional material improvements to the platform technology from Adimab, subject to a commercially reasonable fee to be negotiated by the parties.
1 unchanged sentence
The next potential milestone under the Adimab Platform Transfer Agreement is a mid-six-digit dollar preclinical milestone, which was not considered probable under U.S.
−Removed: GAAP and therefore, no expense was recognized as of March 31, 2024.
+Added: GAAP and therefore, no expense was recognized as of June 30, 2024.
In addition, the Company is obligated to pay Adimab royalties of a low single-digit percentage based on net sales of products containing an antibody discovered, engineered or optimized using Adimab’s platform technology, subject to reductions specified under the Adimab Platform Transfer Agreement.
Royalties are due on a product-by-product and country-by-country basis.
−Removed: The royalty term will expire for each product on a country-by-country basis upon the later of (i) 12 years after the first commercial sale of such product in such country and (ii) the expiration of the last valid claim of a program antibody patent for covering the program antibody contained
−Removed: in such product in such country.
−Removed: Through March 31, 2024, the Company had not paid any royalties to Adimab under the Adimab Platform Transfer Agreement.
+Added: The royalty term will expire for each product on a country-by-country basis upon the later of (i) 12 years after the first commercial sale of such product in such country and (ii) the expiration of the last valid claim of a program antibody patent for covering the program antibody contained in such product in such country.
+Added: Through June 30, 2024, no royalty payments have been paid to or have been earned by Adimab under the Adimab Platform Transfer Agreement.
The Company may terminate the Adimab Platform Transfer Agreement at any time upon advance written notice to Adimab.
12 unchanged sentences
Royalties are due on a Licensed Product-by-Licensed Product basis commencing on the date of the first commercial sale of the applicable product and continuing for so long as the Company commercializes Licensed Products or, if earlier, until the Company exercises its option to buy out the royalty obligations.
−Removed: Through March 31, 2024 , no royalties had become due to WuXi Biologics.
+Added: Through June 30, 2024 , no royalties had become due to WuXi Biologics.
The Cell Line License Agreement remains in effect until it is terminated.
5 unchanged sentences
The Cell Line License Agreement did not qualify as a business combination because substantially all of the fair value of the assets acquired was concentrated in a single asset.
−Removed: The Company did no t recognize any IPR&D expense under the Cell Line License Agreement during the three months ended March 31, 2024 .
−Removed: The Company recognized $ 0.4 million of IPR&D expense under the Cell Line License Agreement during the three months ended March 31, 2023 .
+Added: The Company did no t recognize any IPR&D expense under the Cell Line License Agreement during the three and six months ended June 30, 2024 .
+Added: The Company recognized $ 0.2 million and $ 0.6 million of IPR&D expense under the Cell Line License Agreement during the three and six months ended June 30, 2023 , respectively.
Population Health Partners, L.P.
2 unchanged sentences
The term of the PHP MSA commenced on the PHP Effective Date for an initial term of one year.
−Removed: The PHP MSA renews for subsequent periods, until terminated in accordance with its terms.
+Added: The PHP MSA renewed for subsequent periods, until terminated in accordance with its terms.
+Added: The PHP MSA was terminated effective in July 2024.
On the PHP Effective Date, the Company and PHP entered into the first work order under the PHP MSA (the “PHP Work Order”), pursuant to which PHP agreed to advise and counsel the Company regarding clinical development and regulatory matters with respect to the Company’s product candidates.
The PHP Work Order was effective for six months from the PHP Effective Date and terminated in accordance with its terms in May 2023.
−Removed: The PHP MSA contains customary confidentiality provisions and representations and warranties of the parties, as well as mutual non-solicitation of certain employees during the term of the PHP MSA and for a period of one year thereafter.
+Added: The PHP MSA contained customary confidentiality provisions and representations and warranties of the parties, as well as mutual non-solicitation of certain employees during the term of the PHP MSA and for a period of one year thereafter.
As compensation for the services and deliverables under the PHP Work Order, the Company paid PHP a cash fee of $ 0.5 million per month during the term of the PHP Work Order for an aggregate fee of $ 3.0 million (the “Aggregate Fee”).
−Removed: During the three months ended March 31, 2024 , the Company did no t recognize any research and development expense related to the cash compensation paid to PHP.
−Removed: During the three months ended March 31, 2023 , the Company recognized $ 1.5 million of research and development expense related to the cash compensation paid to PHP.
+Added: During the three and six months ended June 30, 2024 , the Company did no t recognize any research and development expense related to the cash compensation paid to PHP.
+Added: During the three and six months ended June 30, 2023 , the Company recognized $ 0.8
+Added: million and $ 2.3 million, respectively, of research and development expense related to the cash compensation paid to PHP.
Please refer to Note 15 for additional information.
13 unchanged sentences
Refer to Note 11 for additional information on the PHP Warrant.
−Removed: Clive Meanwell, M.D.
−Removed: and Tamsin Berry, members of the Company’s board of directors, are Managing Partner and Limited Partner of PHP, respectively.
+Added: Tamsin Berry, a member of the Company’s board of directors, is a Limited Partner of PHP.
Commitments and Contingencies
Operating Lease Commitments
−Removed: In September 2021, the Company entered into a five-year noncancelable facilities lease agreement for approximately 9,600 square feet of office space in Waltham, Massachusetts.
−Removed: The monthly rental payments under the lease, which include base rent charges of $ 0.4 million per year, are subject to periodic rent increases through September 2026.
−Removed: In addition to base rent, monthly rental payments include the Company’s proportionate share of operating expenses.
−Removed: The lease terms provide for one five-year extension term with base rent calculated on the then-market rate.
−Removed: In June 2022, the Company entered into a two-year noncancelable agreement for dedicated laboratory and office space in Newton, Massachusetts (the “Newton, MA Lease”).
−Removed: The monthly rental payments under the agreement include base rent charges of $ 0.7 million per year.
−Removed: The agreement terms provide for a month-to-month extension after completion of the initial two-year term with base rent calculated on the then-market rate with three months’ prior notice.
−Removed: In September 2022, the Company amended the Newton, MA Lease.
−Removed: Pursuant to the amendment, the Company entered into a separate two-year noncancelable agreement for new dedicated laboratory and office space on the same campus as the Newton, MA Lease.
+Added: In September 2021, the Company entered into a five-year noncancelable facilities lease agreement for approximately 9,600 square feet of office space in Waltham, Massachusetts, which provides for monthly rental payments, including base rent charges of $ 0.4 million per year, subject to periodic rent increases, and the Company’s proportionate share of operating expenses.
+Added: In June 2022, the Company entered into a two-year noncancelable agreement for dedicated laboratory and office space in Newton, Massachusetts, which was amended in September 2022 (the “Newton, MA Lease”).
+Added: Pursuant to the amended Newton, MA Lease, the Company entered into a two-year noncancelable agreement for new dedicated laboratory and office space in Newton, Massachusetts, on the same campus as, and in lieu of, the space leased under the original lease.
The Company took occupancy of the new dedicated laboratory and office space in December 2022.
−Removed: The monthly rental payments under the amended agreement include base rent charges of $ 1.3 million per year.
−Removed: The agreement terms provide for a month-to-month extension, after completion of the initial two-year term extending through November 2024, with base rent calculated on the then-market rate with three months ’ prior notice.
+Added: The amended Newton, MA Lease provides for monthly rental payments, including base rent charges of $ 1.3 million per year, and a month-to-month extension after completion of the initial two-year term extending through November 2024, with base rent calculated on the then-market rate with three months’ prior notice.
The components of operating lease expense were as follows (in thousands):
For the Three Months
−Removed: Ended March 31,
+Added: Ended June 30,
For the Three Months
−Removed: Ended March 31,
+Added: Ended June 30,
+Added: For the Six Months
+Added: Ended June 30,
+Added: For The Six Months
+Added: Ended June 30,
Operating lease cost
3 unchanged sentences
Operating cash flows related to operating leases
−Removed: Future minimum lease payments under the noncancelable leases as of March 31, 2024 was as follows (in thousands):
+Added: Future minimum lease payments under the noncancelable leases as of June 30, 2024 was as follows (in thousands):
Year Ending December 31,
Operating Lease
−Removed: 2024 (excluding the three months ended March 31, 2024)
+Added: 2024 (excluding the six months ended June 30, 2024)
Total lease payments
1 unchanged sentence
Present value of operating lease liability
−Removed: As of March 31, 2024 , the Company’s operating leases were measured using a weighted-average incremental borrowing rate of 6.0 % over a weighted-average remaining lease term of 1.7 years.
−Removed: As of March 31, 2023 , the Company’s operating leases were measured using a weighted-average incremental borrowing rate of 6.0 % over a weighted-average remaining lease term of 2.3 years.
+Added: As of June 30, 2024 , the Company’s operating leases were measured using a weighted-average incremental borrowing rate of 6.0 % over a weighted-average remaining lease term of 0.5 years.
+Added: As of June 30, 2023 , the Company’s operating leases were measured using a weighted-average incremental borrowing rate of 6.0 % over a weighted-average remaining lease term of 2.2 years.
The total operating liabilities are presented on the Company’s condensed consolidated balance sheet based on maturity dates.
−Removed: $ 1.1 million is classified under “ operating lease liabilities, current” for the portion due within twelve months, and $ 0.6 million is classified under “operating lease liabilities, non-current”.
+Added: $ 0.7 million is classified under “ operating lease liabilities, current” for the portion due within twelve months.
+Added: There was no operating lease liability classified under “operating lease liabilities, non-current”.
License Agreements
8 unchanged sentences
The Commercial Manufacturing Agreement outlines the terms and conditions under which WuXi Biologics manufactures drug substance and drug product for commercial use.
−Removed: Through March 31, 2024, the Company committed to noncancelable purchase obligations related to commercial drug substance and drug product manufacturing under the Commercial Manufacturing Agreement.
−Removed: As of March 31, 2024, the total remaining contractually binding commercial drug substance and drug product purchase obligations due to WuXi Biologics was $ 69.3 million,
−Removed: which is expected to be paid in 2024 and 2025.
−Removed: As of March 31, 2024, $ 18.4 million related to the contractually binding commercial drug substance and drug product batches was included in accounts payable and accrued expenses, which is expected to be paid in 2024.
−Removed: Through March 31, 2024, the Company committed to noncancelable purchase obligations of $ 24.7 million related to the procurement of materials to be used in future drug substance and drug product manufacturing under the Commercial Manufacturing Agreement, which is expected to be paid in 2024.
+Added: Through June 30, 2024, the Company committed to noncancelable purchase obligations related to commercial drug substance and drug product manufacturing under the Commercial Manufacturing Agreement.
+Added: As of June 30, 2024 , the total remaining contractually binding commercial drug substance and drug product purchase obligations due to WuXi Biologics was $ 52.6 million, which is expected to be paid in 2024 and 2025.
+Added: As of June 30, 2024 , $ 15.6 million related to the contractually binding commercial drug substance and drug product batches was included in accounts payable and accrued expenses, which is expected to be paid in 2024.
+Added: Through June 30, 2024, the Company committed to noncancelable purchase obligations related to the procurement of materials to be used in future drug substance and drug product manufacturing under the Commercial Manufacturing Agreement.
+Added: As of June 30, 2024 , the total remaining contractually binding purchase obligations due to WuXi Biologics was $ 24.7 million, which is expected to be paid in 2024 and 2025.
+Added: As of June 30, 2024 , $ 6.0 million related to the procurement of materials to be used in future drug substance and drug product manufacturing was included in accounts payable and accrued expenses, which is expected to be paid in 2024.
Unless earlier terminated, the Commercial Manufacturing Agreement remains in effect for an initial period of five years from the date of the last amendment and restatement of the agreement and thereafter automatically renews for further successive periods of five years each.
9 unchanged sentences
The actual amounts the Company could pay in the future to the vendors under such agreements may differ from the purchase order amounts due to cancellation provisions.
−Removed: The termination fees were not probable of payment as of March 31, 2024 and December 31, 2023.
+Added: The termination fees were not probable of payment as of June 30, 2024 and December 31, 2023.
Legal Proceedings
15 unchanged sentences
The lead plaintiffs filed an opposition to the motion to dismiss on February 26, 2024, and the defendants filed a reply in further support of their motion to dismiss on March 27, 2024.
−Removed: The court has scheduled a hearing on the defendants’ motion to dismiss on May 10, 2024.
+Added: The court heard oral arguments on the defendants’ motion to dismiss on May 10, 2024, and took the matter under advisement.
The Company believes that is has strong defenses, and it intends to vigorously defend against this action.
6 unchanged sentences
Shares Reserved for Future Issuance
−Removed: As of March 31, 2024 , the Company had reserved 46,292,290 shares of common stock for the exercise of outstanding stock options and the issuance of awards available for grant under the Company’s 2020 Equity Incentive Plan, 2021 Equity Incentive Plan and 2021 Employee Stock Purchase Plan (see Note 10).
+Added: As of June 30, 2024 , the Company had reserved 46,070,885 shares of common stock for the exercise of outstanding stock options and the issuance of awards available for grant under the Company’s 2020 Equity Incentive Plan, 2021 Equity Incentive Plan and 2021 Employee Stock Purchase Plan (see Note 11).
Shelf Registration Statement
1 unchanged sentence
333-267643) and an accompanying base prospectus, which was declared effective by the SEC on October 5, 2022, for the offer and sale of up to $ 400 million of the Company’s securities.
−Removed: As of March 31, 2024 , $ 325 million of the Company’s securities remained available for offer and sale under this shelf registration statement.
+Added: As of June 30, 2024 , $ 325 million of the Company’s securities remained available for offer and sale under this shelf registration statement.
In December 2023, the Company entered into a Controlled Equity Offering SM Sales Agreement (the “Sales Agreement”) with Cant or Fitzgerald & Co., as sales agent (“Cantor”), pursuant to which the Company may, at its option, offer and sell shares of its common stock, with a sales value of up to $ 75.0 million, from time to time, through Cantor, acting as sales agent, in transactions deemed to be “at the market offerings”, as defined in Rule 415 under the Securities Act of 1933, as amended.
1 unchanged sentence
In February 2024, the Company sold 9,000,000 shares of its common stock under the Sales Agreement at an average price of $ 4.50 per share for $ 39.3 million in net proceeds.
−Removed: As of March 31, 2024 , $ 34.5 million remained available for sale under the Sales Agreement.
+Added: As of June 30, 2024 , $ 34.5 million remained available for sale under the Sales Agreement.
Treasury Stock
22 unchanged sentences
Certain awards of stock options permit the holders to exercise the option in whole or in part prior to the full vesting of the option in exchange for unvested shares of restricted common stock with respect to any unvested portion of the option so exercised.
−Removed: As of March 31, 2024, there were 4,298,068 shares authorized to be issued upon the exercise of outstanding stock option grants and no shares reserved for future issuance under the 2020 Plan.
+Added: As of June 30, 2024, there were 3,582,262 shares authorized to be issued upon the exercise of outstanding stock option grants and no shares reserved for future issuance under the 2020 Plan.
2021 Equity Incentive Plan
8 unchanged sentences
The shares of common stock underlying any awards that are forfeited, cancelled, held back upon exercise or settlement of an award to satisfy the exercise price or tax withholding, repurchased or are otherwise terminated by the Company under the 2021 Plan will be added back to the shares of common stock available for issuance under the 2021 Plan.
−Removed: As of March 31, 2024 , there were an aggregate of 45,301,059 shares authorized to be issued under the 2020 Plan and the 2021 Plan, which included 4,298,068 and 22,065,965 shares authorized to be issued upon the exercise of outstanding stock option grants from the 2020 Plan and 2021 Plan, respectively, and 0 and 18,937,026 shares reserved for future issuance under the 2020 Plan and 2021 Plan, respectively.
+Added: As of June 30, 2024 , there were an aggregate of 45,128,836 shares authorized to be issued under the 2020 Plan and the 2021 Plan, which included 3,582,262 and 21,448,387 shares authorized to be issued upon the exercise of outstanding stock option grants from the 2020 Plan and 2021 Plan, respectively, and 0 and 20,098,187 shares reserved for future issuance under the 2020 Plan and 2021 Plan, respectively.
Stock Option Valuation
8 unchanged sentences
The following table presents, on a weighted-average basis, the assumptions used in the Black-Scholes option-pricing model to determine the grant date fair value of stock options granted:
−Removed: Three Months Ended March 31,
−Removed: Three Months Ended March 31,
+Added: Three Months Ended June 30,
+Added: Three Months Ended June 30,
+Added: Six Months Ended
+Added: Six Months Ended
Expected term (in years)
6 unchanged sentences
Outstanding at December 31, 2023
−Removed: Outstanding at March 31, 2024
−Removed: Vested and expected to vest at March 31, 2024
−Removed: Options exercisable at March 31, 2024
−Removed: The weighted-average grant date fair value of stock options granted during the three months ended March 31, 2024 and 2023 was $ 2.53 and $ 1.34 , respectively, per share.
−Removed: The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying options and the fair market value of the common stock for the options that had exercise prices lower than the estimated fair value of the Company’s common stock at March 31, 2024 and 2023.
−Removed: The total intrinsic value of stock options exercised was $ 0 and $ 0.3 million for the three months ended March 31, 2024 and 2023, respectively.
+Added: Outstanding at June 30, 2024
+Added: Vested and expected to vest at June 30, 2024
+Added: Options exercisable at June 30, 2024
+Added: The weighted-average grant date fair value of stock options granted during the three and six months ended June 30, 2024 was $ 1.48 and $ 2.21 , respectively, per share.
+Added: The weighted-average grant date fair value of stock options granted during the three and six months ended June 30, 2023 was $ 0.86 and $ 1.18 , respectively, per share.
+Added: The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying options and the fair market value of the common stock for the options that had exercise prices lower than the estimated fair value of the Company’s common stock at June 30, 2024 and 2023.
+Added: The total intrinsic value of stock options exercised was $ 0.2 million for both the three and six months ended June 30, 2024 .
+Added: The total intrinsic value of stock options exercised was $ 0.1 million and $ 0.4 million for the three and six months ended June 30, 2023, respectively.
Stock-Based Compensation Expense
The Company recorded stock-based compensation expense (service-based stock options and employee stock purchase plan) in the following expense categories of its condensed consolidated statements of operations and comprehensive loss (in thousands):
−Removed: Three Months Ended March 31,
−Removed: Three Months Ended March 31,
+Added: Three Months Ended June 30,
+Added: Three Months Ended June 30,
+Added: Six Months Ended
+Added: Six Months Ended
Research and development
Selling, general and administrative
−Removed: As of March 31, 2024 , total unrecognized stock-based compensation expense related to unvested stock-based awards was $ 40.2 million, which is expected to be recognized over a weighted-average period of 2.4 years.
+Added: As of June 30, 2024, $ 0.6 million of share-based compensation expense was capitalized and recorded as Inventory in the accompanying condensed consolidated balance sheet.
+Added: In April 2024, David Hering ceased serving as the Company’s Chief Executive Officer and as a member of the Company’s board of directors.
+Added: Pursuant to his separation agreement, the Company recognized approximately $ 5.5 million of selling, general, and administrative related stock-based compensation expense associated with the accelerated vesting of a portion of his outstanding stock options, in accordance with the terms of his employment agreement.
+Added: As of June 30, 2024 , total unrecognized stock-based compensation expense related to unvested stock-based awards was $ 28.4 million, which is expected to be recognized over a weighted-average period of 2.4 years.
2021 Employee Stock Purchase Plan
1 unchanged sentence
A total of 1,342,773 shares of common stock were initially reserved for issuance under the 2021 ESPP.
−Removed: There were 351,542 shares issued under the 2021 ESPP as of March 31, 2024 .
+Added: There were 400,724 shares issued under the 2021 ESPP as of June 30, 2024 .
The number of shares of common stock that may be issued under the 2021 ESPP will automatically increase on the first day of each calendar year, pursuant to the evergreen provision thereof, beginning on January 1, 2022 and continuing through January 1, 2031, by an amount equal to the lesser of (i) 1 % of the shares of common stock outstanding on the last day of the calendar month before the date of each automatic increase, (ii) 2,685,546 shares and (iii) an amount determined by the Company’s board of directors.
1 unchanged sentence
The first offering under the 2021 ESPP was June 6, 2022.
−Removed: As of March 31, 2024 , 991,231 shares remained available for issuance under the 2021 ESPP.
−Removed: During both the three months ended March 31, 2024 and 2023 , the Company recognized less than $ 0.1 million in related stock-based compensation expense.
+Added: As of June 30, 2024 , 942,049 shares remained available for issuance under the 2021 ESPP.
+Added: During both the three and six months ended June 30, 2024 , the Company recognized less than $ 0.1 million in related
+Added: stock-based compensation expense.
+Added: During both the three and six months ended June 30, 2023 , the Company recognized less than $ 0.1 million in related stock-based compensation expense.
Warrant Expense
5 unchanged sentences
The aggregate grant date fair value of the PHP Warrant was $ 17.4 million, which was recognized as warrant expense on the grant date in November 2022.
−Removed: There were no warrants issued during the three months ended March 31, 2024.
−Removed: As of March 31, 2024 , there were 6,824,712 warrants outstanding at a weighted-average exercise price of $ 3.48 , with a weighted-average remaining contractual term of 8.63 years.
−Removed: For the three months ended March 31, 2024 and 2023, the Company recorded no income tax benefits for the net operating losses incurred or for the research and development tax credits generated in each period, due to its uncertainty of realizing a benefit from those items.
+Added: There were no warrants issued during the three and six months ended June 30, 2024.
+Added: As of June 30, 2024 , there were 6,824,712 warrants outstanding at a weighted-average exercise price of $ 3.48 , with a weighted-average remaining contractual term of 8.38 years.
+Added: For the three and six months ended June 30, 2024 and 2023, the Company recorded no income tax benefits for the net operating losses incurred or for the research and development tax credits generated in each period, due to its uncertainty of realizing a benefit from those items.
Substantially all of the Company’s operating losses since inception have been generated in the U.S.
3 unchanged sentences
Pursuant to the terms of the 401(k) Plan, the Company is required to make non-elective contributions of 3 % of eligible participants’ compensation.
−Removed: For both the three months ended March 31, 2024 and 2023 , the Company contributed $ 0.2 million to the 401(k) Plan.
+Added: For the three and six months ended June 30, 2024 and 2023 , the Company contributed $ 0.1 million and $ 0.3 million, respectively, to the 401(k) Plan.
Net Loss per Share
Basic and diluted net loss per share attributable to common stockholders was calculated as follows (in thousands, except share and per share amounts):
−Removed: Three Months Ended March 31,
−Removed: Three Months Ended March 31,
+Added: Three Months Ended June 30,
+Added: Three Months Ended June 30,
+Added: Six Months Ended June 30,
+Added: Six Months Ended June 30,
Net loss attributable to common stockholders
1 unchanged sentence
Net loss per share attributable to common stockholders, basic and diluted
−Removed: Shares of unvested restricted common stock are not considered outstanding for accounting purposes until vested and were excluded from the calculations of basic net loss per share attributable to common stockholders for the three months ended March 31, 2023.
−Removed: There were no shares of unvested restricted common stock for the three months ended March 31, 2024.
+Added: Shares of unvested restricted common stock are not considered outstanding for accounting purposes until vested and were excluded from the calculations of basic net loss per share attributable to common stockholders for the three and six months ended June 30, 2023.
+Added: There were no shares of unvested restricted common stock for the three and six months ended June 30, 2024.
The Company’s potential dilutive securities have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share.
1 unchanged sentence
The Company excluded the following potential common shares, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share attributable to common stockholders for the periods indicated, because including them would have had an anti-dilutive effect:
−Removed: For the Three Months
−Removed: Ended March 31,
−Removed: For the Three Months
−Removed: Ended March 31,
+Added: For the Six Months
+Added: Ended June 30,
+Added: For the Six Months
+Added: Ended June 30,
Stock options to purchase common stock
2 unchanged sentences
Related Party Transactions
−Removed: As of both March 31, 2024 and December 31, 2023 , an aggregate of $ 0.7 million was due to Adimab under the Adimab Assignment Agreement, the Adimab Collaboration Agreement, the Adimab Platform Transfer Agreement and the Adimab DNA Sequencing Services Agreement (as defined below) by the Company.
−Removed: As of March 31, 2024 and December 31, 2023 , no amounts were due to the Company from Adimab under the Adimab Assignment Agreement, the Adimab Collaboration Agreement, the Adimab Platform Transfer Agreement or the Adimab DNA Sequencing Services Agreement.
+Added: As of both June 30, 2024 and December 31, 2023 , an aggregate of $ 0.7 million was due to Adimab under the Adimab Assignment Agreement, the Adimab Collaboration Agreement, the Adimab Platform Transfer Agreement and the Adimab DNA Sequencing Services Agreement (as defined below) by the Company.
+Added: As of June 30, 2024 and December 31, 2023 , no amounts were due to the Company from Adimab under the Adimab Assignment Agreement, the Adimab Collaboration Agreement, the Adimab Platform Transfer Agreement or the Adimab DNA Sequencing Services Agreement.
Adimab Assignment Agreement
Under the Adimab Assignment Agreement, Adimab, a principal stockholder of the Company, is entitled to receive milestone and royalty payments upon specified conditions and receives payments from the Company for providing ongoing services under the agreement (see Note 7).
−Removed: During the three months ended March 31, 2024, the Company did no t recognize any IPR&D expense with respect to milestones payable under the Adimab Assignment Agreement.
−Removed: During the three months ended March 31, 2023 , the Company recognized $ 0.4 million as IPR&D expense with respect to a milestone payable under the Adimab Assignment Agreement.
−Removed: During both the three months ended March 31, 2024 and 2023 , the Company did no t recognize any research and development expense with respect to services performed by Adimab on the Company ’s behalf under the Adimab Assignment Agreement.
+Added: During both the three and six months ended June 30, 2024, the Company did no t recognize any IPR&D expense with respect to contingent consideration payable under the Adimab Assignment Agreement.
+Added: During the three and six months ended June 30, 2023 , the Company recognized $ 0 and $ 0.4 million, respectively, as IPR&D expense with respect to a milestone payable under the Adimab Assignment Agreement.
+Added: During the three and six months ended June 30, 2024 and 2023 , the Company did no t recognize any research and development expense with respect to services performed by Adimab on the Company ’s behalf under the Adimab Assignment Agreement.
Adimab Collaboration Agreement
Under the Adimab Collaboration Agreement, the Company is obligated to pay Adimab for certain fees, milestones and royalty payments (see Note 7).
−Removed: During the three months ended March 31, 2024 and 2023 , the Company recognized $ 0.6 million and $ 1.3 million, respectively, of research and development expense related to the quarterly fee under the Adimab Collaboration Agreement.
−Removed: During the three months ended March 31, 2024 , the Company did no t recognize any research and development expense with respect to services performed by Adimab on the Company’s behalf under the Adimab Collaboration Agreement.
−Removed: During the three months ended March 31, 2023 , the Company recognized $ 0.2 million of research and development expense with respect to services performed by Adimab on the Company’s behalf under the Adimab Collaboration Agreement.
+Added: During the three and six months ended June 30, 2024 , the Company recognized $ 0.6 million and $ 1.2 million, respectively, of research and development expense related to the quarterly fee under the Adimab Collaboration Agreement.
+Added: During the three and six months ended June 30, 2023 , the Company recognized $ 1.3 million and $ 2.6 million, respectively, of research and development expense related to the quarterly fee under the Adimab Collaboration Agreement.
+Added: During both the three and six months ended June 30, 2024 , the Company did no t recognize any research and development expense with respect to services performed by Adimab on the Company’s behalf under the Adimab Collaboration Agreement.
+Added: During the three and six months ended June 30, 2023 , the Company recognized $ 0.2 million and $ 0.4 million, respectively, of research and development expense with respect to services performed by Adimab on the Company’s behalf under the Adimab Collaboration Agreement.
Adimab Platform Transfer Agreement
Under the Adimab Platform Transfer Agreement, the Company is obligated to pay Adimab for certain fees, milestones and royalty payments (see Note 7).
−Removed: During the three months ended March 31, 2024, the Company recognized a portion of the first annual fee as research and development expense.
−Removed: During the three months ended March 31, 2023, the Company did not recognize any research and development expense in connection with the Adimab Platform Transfer Agreement.
+Added: During the three and six months ended June 30, 2024, the Company recognized a portion of the first annual fee as research and development expense under the Adimab Platform Transfer Agreement.
+Added: During both the three and six months ended June 30, 2023, the Company did not recognize any research and development expense under the Adimab Platform Transfer Agreement.
Adimab DNA Sequencing Services Agreement
1 unchanged sentence
In exchange for the services performed, the Company will pay Adimab a fee for each yeast-derived DNA template sample present in the well within the sequencer plate.
−Removed: During the three months ended March 31, 2024, the Company recognized less than $ 0.1 million of research and development expense with respect to services performed by Adimab on the Company’s behalf under the Adimab DNA Sequencing Services Agreement.
−Removed: The Adimab DNA Sequencing Services Agreement was not effective during the three months ended March 31, 2023.
+Added: During both the three and six months ended June 30, 2024 , the Company recognized less than $ 0.1 million of research and development expense with respect to services performed by Adimab on the Company’s behalf under the Adimab DNA Sequencing Services Agreement.
+Added: During both the three and six months ended June 30, 2023 , the Company recognized less than $ 0.1 million of research and development expense with respect to services performed by Adimab on the Company’s behalf under the Adimab DNA Sequencing Services Agreement
Population Health Partners, L.P.
Under the PHP MSA and PHP Work Order, the Company was obligated to pay cash compensation for services and deliverables (see Note 8).
−Removed: Clive Meanwell, M.D.
−Removed: and Tamsin Berry, members of the Company’s board of directors, are Managing Partner and Limited Partner of PHP, respectively.
−Removed: During the three months ended March 31, 2023 , the Company recognized $ 1.5 million of research and development expense related to services performed by PHP in connection with the PHP Work Order, which terminated in accordance with its terms in May 2023.
−Removed: As of March 31, 2024 , no amounts were due to PHP by the Company, and no amounts were due from PHP to the Company.
+Added: Tamsin Berry, a member of the Company’s board of directors, is a Limited Partner of PHP.
+Added: During the three and six months ended June 30, 2024 , the Company did no t recognize any research and development expense related to the cash compensation paid to PHP.
+Added: During the three and six months ended June 30, 2023 , the Company recognized $ 0.8 million and $ 2.3 million, respectively, of research and development expense related to services performed by PHP in connection with the PHP Work Order, which terminated in accordance with its terms in May 2023.
+Added: As of June 30, 2024 , no amounts were due to PHP by the Company, and no amounts were due from PHP to the Company.
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.