As discussed further in Note 8, Leases, to the consolidated financial statements included in the Company's 2023 Annual Report on Form 10-K, the Company maintains letters of credit related to its leases in Cambridge and Seattle. A portion of this collateral is classified as restricted investments and included within restricted investments and other non-current assets on the condensed consolidated balance sheets.
The following table summarizes restricted investments held at September 30, 2024 and December 31, 2023 (in thousands):
The Company leases certain office and laboratory space, primarily located in Cambridge, Massachusetts and Seattle, Washington, which was assigned to it in connection with its separation from bluebird bio. The lease at 60 Binney Street, Cambridge, Massachusetts for 253,108 square feet (the “Prime Lease”) was previously entered into by bluebird bio with ARE-MA Region No. 40, LLC on September 21, 2015. The lease at 188 East Blaine Street in Seattle, Washington for 36,126 square feet was previously entered into by bluebird bio on July 18, 2018.
In connection with the Regeneron Transaction, Regeneron agreed to fully sublease the Company’s facilities in Seattle, Washington and sublease a portion of the Company’s facilities in Cambridge, Massachusetts. As part of the sublease agreement with Regeneron (the “Subtenant”), the Company agreed to sublease to Regeneron approximately 159,106 square feet of space in Cambridge and approximately 36,126 square feet of space in Seattle. The Company remains the primary obligor of the leases. In each case, the monthly base rent for the sublease is equal to the rate per square foot paid by the Company, which is subject to annual rent increases.
For the Prime Lease, in addition to base rent, the Subtenant is responsible for its allocated share of costs incurred and expenditures made by the Company in the operation and management of the subleased space. The Subtenant has agreed to pay its proportionate share (63%) of all operating expenses, taxes, insurance, utilities storage, parking fees and all other additional rent payable by the Company under the Prime Lease.
Sublease income from Regeneron will cover a majority of the Company’s future minimum lease commitments through 2027. Total sublease income for the three and nine months ended September 30, 2024 related to the sublease of the Prime Lease was approximately $4.9 million and $9.8 million, respectively. Total sublease income for the three and nine months ended September 30, 2024 related to the sublease of the Seattle lease was approximately $0.6 million and $1.2 million, respectively, which covers all of the Company’s costs for the Seattle facility. This
14
income is netted against the Company’s rent expense, which is included within operating expenses, in the condensed consolidated statements of operations and comprehensive loss.
9. Commitments and contingencies
Contingent consideration related to business combination
On June 30, 2014, bluebird bio acquired Pregenen. All assets, liabilities and future obligations related to the Pregenen acquisition, including the resulting goodwill and contingent consideration, were assumed by the Company in connection with the separation from bluebird bio. The Company may be required to make up to $99.9 million in contingent cash payments to the former equity holders of Pregenen upon the achievement of certain commercial milestones related to the Pregenen technology. In accordance with accounting guidance for business combinations, contingent consideration liabilities are required to be recognized on the condensed consolidated balance sheets at fair value. Estimating the fair value of contingent consideration requires the use of significant assumptions primarily relating to probabilities of successful achievement of certain clinical and commercial milestones, the expected timing in which these milestones will be achieved and discount rates. The use of different assumptions could result in materially different estimates of fair value. As of September 30, 2024, the Company determined the probability of milestone achievement to be zero and as a result reduced the fair value of contingent consideration included in other non-current liabilities on the condensed consolidated balance sheets to zero. Please refer to Note 5, Fair value measurements, for further information.
Other funding commitments
Certain agreements that were assigned by bluebird bio to the Company in connection with the separation relate principally to licensed technology and may require future payments relating to milestones that may be met in subsequent periods or royalties on future sales of specified products. Additionally, to the extent an agreement relating to licensed technology was not assigned to the Company, bluebird bio entered into a sublicense with the Company, which may require the Company to make future milestone and/or royalty payments.Please refer to Note 11, Collaborative arrangements and strategic partnerships, for further information on the BMS, Regeneron, and Novo Nordisk A/S agreements and to Note 12, Royalty and other revenue, for further information on license agreements.
Based on the Company's development plans as of September 30, 2024, the Company may be obligated to make future development, regulatory and commercial milestone payments and royalty payments on future sales of specified products. Payments under these agreements generally become due and payable upon achievement of such milestones or sales. When the achievement of these milestones or sales has not occurred, such contingencies are not recorded in the Company’s condensed consolidated financial statements. As further discussed in Note 11, Collaborative arrangements and strategic partnerships, BMS assumed responsibility for amounts due to licensors as a result of any future ex-U.S. sales of Abecma.
Collaborative arrangements and strategic partnerships, to the consolidated financial statements included in the Company's 2023 annual report on Form 10-K. During the second quarter of 2023, the Company entered into an amendment to the collaboration agreement with BMS to assign future manufacturing of lentiviral vector to BMS, as further described in Note 8, Commitments and contingencies, to the consolidated financial statements included in the Company's 2023 annual report on Form 10-K.
Abecma
Under the collaboration agreement with BMS, the Company shares equally in the profit and loss related to the development and commercialization of ide-cel in the United States (marketed as Abecma). If the Company were to choose to terminate its existing agreement with BMS, it would be entitled to a mid-single digit to low teens royalty based on a percentage of net sales of Abecma in the United States with 90 days’ notice. The Company has no remaining financial rights with respect to the development or commercialization of ide-cel outside of the United States. The Company accounts for its collaborative arrangement efforts with BMS in the United States within the scope of ASC 808 given that both parties are active participants in the activities and both parties are exposed to significant risks and rewards dependent on the commercial success of the activities. The calculation of collaborative activity to be recognized for joint Abecma efforts in the United States is performed on a quarterly basis and is independent of previous quarterly activity. This may result in fluctuations between revenue and expense recognition period over period, depending on the varying extent of effort performed by each party during the period. The Company recognizes revenue related to the combined unit of accounting for the ex-U.S. license and lentiviral vector manufacturing services under Topic 606.
Ide-cel U.S. Share of Collaboration Profit or Loss
在2014年6月30日，bluebird bio 收购了Pregenen。与Pregenen收购相关的所有资产、负债和未来义务，包括由此产生的无形资产、商誉和或有对价，均由我们在分拆过程中承担。该协议规定在达到与Pregenen科技相关的某些前临床、临床和商业里程碑时，最高可支付13500万美元的未来或有现金款项。
•$6.2 million of decreased employee compensation costs, primarily resulting from the 40% reduction to our workforce announced in September 2023 and the additional reduction to our workforce announced in January 2024; and
•$1.6 million of decreased consulting and professional service fees.
These decreases were partially offset by:
•$4.9 million of increased facilities costs allocated to selling, general, and administrative costs as a result of the sale of our research and development pipeline to Regeneron and Novo; and
•$3.2 million of increased license and milestone fees in the third quarter of 2024 compared to the third quarter of 2023 due to a $3.5 million license agreement credit recognized during the third quarter of 2023.
Restructuring Expenses. Restructuring expenses were $0.5 million for the three months ended September 30, 2024, compared to $8.6 million for the three months ended September 30, 2023. The decrease in restructuring
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expenses is primarily due to the 2023 Restructuring Plan implemented in September 2023 and substantially completed by June 2024.
Cost of Royalty and Other Revenue. There is no cost of royalty and other revenue for the three months ended September 30, 2024, and total cost of royalty and other revenue was $0.6 million for the three months ended September 30, 2023. The decrease is due to the royalty term relating to Breyanzi ending in August 2023.
Goodwill Impairment Charge. During the third and fourth quarters of 2023, the Company experienced a sustained decline in the price of its common stock in part due to decreased external expectations for future Abecma sales resulting from increased competitive dynamics, which was considered a triggering event. We performed a goodwill impairment test that resulted in a non-cash impairment charge of $12.1 million.
Interest Income, Net. Interest income was $2.9 million for the three months ended September 30, 2024 compared to $3.6 million for the three months ended September 30, 2023. The decrease of $0.8 million is due to a decline in the total securities held and decreases in interest rates over the comparative periods.
Other Income, Net. For the three months ended September 30, 2024 other income, net primarily consisted of rental income and income recognized under our transition service agreements with Regeneron from the Regeneron Transaction. For the three months ended September 30, 2023, other income, net consisted of rental income and income recognized under our transition service agreements with bluebird bio.
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Comparison of the Nine Months Ended September 30, 2024 and 2023:
For the nine months ended September 30,
2024
2023
Change
(in thousands)
Revenue:
Service revenue
$
15,192
$
20,796
$
(5,604)
Collaborative arrangement revenue
19,744
64,265
(44,521)
Royalty and other revenue
—
4,642
(4,642)
Total revenues
34,936
89,703
(54,767)
Operating expenses:
Research and development
68,264
179,541
(111,277)
Cost of manufacturing for commercial collaboration
12,490
11,672
818
Selling, general and administrative
35,400
53,213
(17,813)
Share of collaboration loss
1,230
—
1,230
Restructuring expenses
12,131
8,614
3,517
Cost of royalty and other revenue
—
2,099
(2,099)
Change in fair value of contingent consideration
(2,415)
180
(2,595)
Goodwill impairment charges
—
12,056
(12,056)
Total operating expenses
127,100
267,375
(140,275)
Loss from operations
(92,164)
(177,672)
85,508
Interest income, net
8,243
8,765
(522)
Other income, net
3,233
8,159
(4,926)
Gain on sale to Novo Nordisk
47,987
—
47,987
Loss on assets held for sale to Regeneron
(5,026)
—
(5,026)
Loss before income taxes
(37,727)
(160,748)
123,021
Income tax (expense) benefit
—
—
—
Net loss
$
(37,727)
$
(160,748)
$
123,021
Revenue.Total revenue was $34.9 million for the nine months ended September 30, 2024, compared to $89.7 million for the nine months ended September 30, 2023. The decrease of $54.8 million was primarily attributable to a decrease in collaborative arrangement revenue recognized under our collaboration arrangement with BMS, driven by decreased Abecma sales and higher BMS selling, general and administrative expenses. The decrease was also due to the termination of the Regeneron Collaboration Agreement concurrently with the close of the Regeneron Transaction, which occurred on April 1, 2024.
Research and Development Expenses.Research and development expenses were $68.3 million for the nine months ended September 30, 2024, compared to $179.5 million for the nine months ended September 30, 2023. The overall decrease of $111.3 million was primarily attributable to the following:
•$46.3 million of decreased employee compensation costs, primarily resulting from the Asset Sale, as part of which a large portion of our research and development workforce transitioned to Regeneron. Additionally, there was a 40% reduction to our workforce as part of our restructuring in September 2023 and an additional reduction to our workforce initiated in January 2024;
•$29.6 million of decreased facilities and IT costs largely due to the Asset Sale, which resulted in Regeneron subleasing a significant portion of our current leased space in Cambridge and Seattle, reducing rent and
39
associated facility costs. The remaining decrease is driven by the reduction to our workforce as part of our restructuring;
•$25.2 million of decreased material production costs primarily related to decreased manufacturing activities of suspension lentiviral vector for ide-cel development for the nine months ended September 30, 2024 compared to the nine months ended September 30, 2023. The decrease is also attributable to decreased plasmids and cell bank manufacturing costs, which were assumed by Regeneron as part of the Regeneron Transaction beginning in the second quarter of 2024;
•$10.5 million of decreased lab expenses and other platform costs primarily relating to a decrease in lab consumables costs which were assumed by Regeneron as part of the Asset Sale beginning in the second quarter of 2024;
•$3.2 million in decreased license and milestone fees associated with a milestone paid to Medigene in the first quarter of 2023 for the continued development of our MAGE-A4 TCR program in solid tumors, which was being developed as part of our collaboration with Regeneron;
•$1.8 million decrease in consulting and professional service fees; and
•$1.2 million decrease in clinical trial and medical research costs.
These decreases were partially offset by a $5.8 million increase in net research and development expenses recognized under our collaboration with BMS.
Cost of Manufacturing for Commercial Collaboration. Cost of manufacturing for commercial collaboration was $12.5 million for the nine months ended September 30, 2024, compared to $11.7 million for the nine months ended September 30, 2023. The increase of $0.8 million was primarily due to an increase in quality testing performed by us on Abecma inventory during the nine months ended September 30, 2024 as well as increased costs allocated to Abecma during the third quarter of 2024 upon the completion of our strategic realignment to focus on the development and commercialization of Abecma.
Selling, General and Administrative Expenses. Selling, general and administrative expenses were $35.4 million for the nine months ended September 30, 2024, compared to $53.2 million for the nine months ended September 30, 2023. The decrease of $17.8 million was primarily due to the following:
•$19.7 million decrease in compensation expenses primarily resulting from the 40% reduction in our workforce announced in September 2023 and the additional reduction to our workforce announced in January 2024; and
•$2.5 million decrease in collaboration research funding expenses.
These decreases were partially offset by $5.3 million of increased facilities costs allocated to selling, general, and administrative costs as a result of the sale of our research and development pipeline to Regeneron and Novo.
Share of Collaboration Loss. Share of collaboration loss for the nine months ended September 30, 2024 represents our share of net loss arising from the commercialization of Abecma under the BMS collaboration during the first quarter of 2024. The collaboration resulted in collaborative arrangement revenue during the second and third quarters of 2024.
Restructuring Expenses. The increase in restructuring expenses is primarily due to our share of one-time costs incurred during the second and third quarters of 2024 of $5.7 million associated with BMS’ early exit from a commercial manufacturing and supply agreement as a result of the transition to suspension lentiviral vector for
40
Abecma. The remaining increase is attributable to costs incurred related to the reduction in our workforce as a part of our 2024 Restructuring Plan, initiated in January 2024.
Cost of Royalty and Other Revenue. There is no cost of royalty and other revenue for the nine months ended September 30, 2024, and total cost of royalty and other revenue was $2.1 million for the nine months ended September 30, 2023. The decrease is due to the royalty term relating to Breyanzi ending in August 2023.
Change in Fair Value of Contingent Consideration. The change in fair value of contingent consideration of $2.6 million was primarily due to the change in significant unobservable inputs used in the fair value measurement of contingent consideration, including the probabilities of successful achievement of clinical and commercial milestones and discount rates. As of September 30, 2024, we determined the probability of milestone achievement to be zero and as a result we reduced the fair value of the contingent consideration liability to zero.
Goodwill Impairment Charge. During the third and fourth quarters of 2023, the Company experienced a sustained decline in the price of its common stock in part due to decreased external expectations for future Abecma sales resulting from increased competitive dynamics, which was considered a triggering event. We performed a goodwill impairment test that resulted in a non-cash impairment charge of $12.1 million.
Interest Income, Net. Interest income, net was $8.2 million and $8.8 million for the nine months ended September 30, 2024 and 2023, respectively. The decrease of $0.5 million was due to a decline in the total securities held partially offset by an increase in income earned on securities compared to the prior year.
Gain on sale to Novo Nordisk. In June 2024, the Company announced the completion of an asset purchase agreement with Novo Nordisk A/S. Please refer to Note 3, Asset purchase agreements, in the notes to the condensed consolidated financial statements for further detail regarding the gain on sale related to this transaction.
Loss on assets held for sale to Regeneron. The loss on assets held for sale consists of fixed assets that ceased depreciation, measured at the lower of their carrying value or fair value less cost to sell.
Other Income, Net. For the nine months ended September 30, 2024 other income, net primarily consisted of rental income and income recognized under our transition service agreements with Regeneron from the Regeneron Transaction. For the nine months ended September 30, 2023, other income, net consisted of rental income and income recognized under our transition service agreements with bluebird bio.
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Liquidity and Capital Resources
As of September 30, 2024, we had cash, cash equivalents, and marketable securities of approximately $192.4 million. Based on our current operating plans, including with respect to the ongoing commercialization of Abecma, we expect our cash, cash equivalents and marketable securities will be sufficient to fund current planned operations for at least the next twelve months from the date of issuance of these condensed consolidated financial statements. Our current operating plan is based on various assumptions. If we use our capital resources sooner than expected, we would evaluate further reductions in expense or obtaining additional financing. This may include pursuing a combination of public or private equity offerings, debt financings, collaborations, strategic alliances or licensing arrangements with third parties. This may also include the potential sale of shares of our common stock of up to $150.0 million in gross proceeds under the ATM facility established in November 2022 with Cowen and Company, LLC. No sales of common stock have occurred under this ATM facility as of the date of this Quarterly Report on Form 10-Q. There can be no assurance that such financing will be available in sufficient amounts or on acceptable terms, if at all, and some could be dilutive to existing stockholders. If we are unable to obtain additional funding on a timely basis, we may be forced to significantly curtail, delay, or discontinue one or more of our planned research or development programs or be unable to expand our operations.
We have incurred normal operating losses and have experienced negative operating cash flows for all periods presented. During the nine months ended September 30, 2024, we incurred a loss of $37.7 million and used $75.5 million of cash in operations. We expect to continue to generate operating losses and negative operating cash flows for the near future.
Sources of Liquidity
Cash Flows
The following table summarizes our cash flow activity:
For the nine months ended September 30,
2024
2023
(in thousands)
Net cash used in operating activities
$
(75,524)
$
(103,263)
Net cash provided by (used in) investing activities
58,774
(4,029)
Net cash provided by financing activities
414
127,137
(Decrease) increase in cash, cash equivalents and restricted cash and cash equivalents
$
(16,336)
$
19,845
Cash Flows from Operating Activities. Net cash used in operating activities was $75.5 million for the nine months ended September 30, 2024 and primarily consisted of a net loss of $37.7 million adjusted for non-cash items, including:
•gain on sale to Novo Nordisk of $48.0 million and loss on assets held for sale to Regeneron of $5.0 million;
•stock-based compensation of $9.7 million;
•depreciation and amortization of $5.4 million;
•change in fair value of contingent consideration of $2.4 million; and
•other non-cash items of $3.4 million, as well as the change in our net working capital.
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Net cash used in operating activities was $103.3 million for the nine months ended September 30, 2023 and primarily consisted of net loss of $160.7 million adjusted for non-cash items, including stock-based compensation of $27.2 million, a non-cash goodwill impairment charge of $12.1 million, and depreciation and amortization of $7.3 million, and the change in fair value of contingent consideration of $0.2 million, as well as the change in our net working capital.
Cash Flows from Investing Activities. Net cash provided by investing activities for the nine months ended September 30, 2024 was $58.8 million and was due to:
•proceeds from the Novo Transaction of $38.0 million and proceeds from the Regeneron Transaction of $5.0 million;
•proceeds from maturities of marketable securities of $122.5 million; and
•proceeds from maturities of restricted investments of $15.1 million;
These cash inflows were partially offset by the purchase of marketable securities of $104.5 million, the purchase of restricted investments of $16.8 million, and the purchase of property, plant and equipment of $0.7 million.
Net cash used in investing activities for the nine months ended September 30, 2023 was $4.0 million and was due to the purchase of marketable securities of $237.2 million, the purchase of restricted investments of $7.0 million, and the purchase of property, plant and equipment of $12.8 million, offset by proceeds from maturities of marketable securities of $245.9 million and proceeds from the maturities of restricted investments of $7.0 million.
Cash Flows from Financing Activities. Net cash provided by financing activities for the nine months ended September 30, 2024 was $0.4 million and was primarily due to net proceeds relating to the exercise of stock options and ESPP contributions.
Net cash provided by financing activities for the nine months ended September 30, 2023 was $127.1 million and was primarily due to net proceeds received of $117.0 million from the issuance of common stock in a public offering in March 2023 along with net proceeds of $9.9 million from the issuance of common stock to Regeneron from the January 2023 Share Purchase Agreement.
Funding Requirements
We intend to incur costs in support of the ongoing commercialization of Abecma pursuant to our cost sharing arrangements with BMS, other capital expenditures, working capital requirements, and other general corporate activities.
Based on our current operating plans, including with respect to the ongoing commercialization of Abecma, we expect that our cash, cash equivalents and marketable securities will be sufficient to fund current planned operations for at least the next twelve months from the date of issuance of these condensed consolidated financial statements. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect.
Because of the numerous risks and uncertainties associated with the development and commercialization of Abecma, we are unable to estimate the exact amount of our working capital requirements. The scope of our future funding requirements will depend on, and could increase significantly as a result of, many factors, including:
▪the costs of activities, including clinical trials, sales, marketing, medical affairs, manufacturing and distribution, for Abecma;
43
▪the cost and timing of hiring new employees or contractors to support our activities;
▪the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims; and
▪the timing, receipt and amount of sales of, or milestone payments related to or royalties on Abecma, if any.
A change in the outcome of any of these or other variables could significantly change the costs and timing associated with the development and commercialization of Abecma. Further, our operating plans may change in the future, and we may need additional funds to meet operational needs and capital requirements associated with such operating plans.
Until such time, if ever, as we can generate positive operating cash flows, we may need to finance our operations through a combination of public or private equity offerings, debt financings, collaborations, strategic alliances or licensing arrangements with third parties. To the extent that we raise additional capital through the sale of equity or convertible debt securities, this could result in dilution and could adversely affect the rights of common stockholders. Debt financing and preferred equity financing, if available, may involve agreements that include restrictive covenants that limit our ability to take specified actions, such as incurring additional debt, making capital expenditures or declaring dividends. In addition, debt financing would result in increased fixed payment obligations.
If we raise funds through collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or any future product candidates or grant licenses on terms that may not be favorable to us.
If we are unable to raise additional funds when needed, we may be required to delay, reduce or eliminate our product development for additional indications of Abecma or future commercialization efforts.
Contractual Obligations and Commitments
In connection with the Regeneron Transaction, Regeneron agreed to sublease our facilities in Seattle, Washington and a portion of our facilities in Cambridge, Massachusetts. The expected sublease income will cover a majority of the future minimum commitments through 2027. Please refer to Note 8, Leases, in the notes to the condensed consolidated financial statements included elsewhere in the Form 10-Q for further information regarding our future minimum commitments under ASC 842 under our operating leases and Note 3, Asset Purchase Agreements, for further information on the closing on the transaction with Regeneron. Additionally, 2seventy bio was party to various contracts with contract research organizations and contract manufacturers that generally provide for termination on notice, with the exact amounts in the event of termination to be based on the timing of the termination and the terms of the agreement. The majority of these contracts were assumed by Regeneron upon or after closing of the Regeneron Transaction. For any contracts remaining, other than a decrease in committed spend due to the payment of these obligations in the normal course of business, there have been no other material changes to our contractual obligations and commitments as included in our audited consolidated financial statements included in our 2023 annual report on Form 10-K.
Emerging Growth Company Status
The Jumpstart Our Business Startups Act of 2012 permits an “emerging growth company” such as us to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies until those standards would otherwise apply to private companies. We have elected not to “opt out” of such extended transition period, which means that when a standard is issued or revised and it has different application dates for public or private companies, we will adopt the new or revised standard at the time private companies adopt the new or revised standard and will do so until such time that we either (i) irrevocably elect to “opt out” of such extended transition period or (ii) no longer qualify as an emerging growth company. We may choose to early adopt any new or revised accounting standards whenever such early adoption is permitted for private companies.
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ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Interest rate fluctuation risk
We are exposed to market risk related to changes in interest rates. As of September 30, 2024, we had cash, cash equivalents and marketable securities of $192.4 million, primarily invested in U.S. government agency securities and treasuries and commercial paper. Our primary exposure to market risk is interest rate sensitivity, which is affected by changes in the general level of U.S. interest rates, particularly because our investments are in short-term securities. Our available for sale securities are subject to interest rate risk and will fall in value if market interest rates increase. If market interest rates were to increase immediately and uniformly by 100 basis points, or one percentage point, from levels at September 30, 2024, the net fair value of our interest-sensitive marketable securities and restricted investments would have resulted in a hypothetical decline of $0.8 million.
Foreign currency fluctuation risk
We are not currently exposed to significant market risk related to changes in foreign currency exchange rates; however, we have contracted with and may continue to contract with foreign vendors. Our operations may be subject to fluctuations in foreign currency exchange rates in the future.
Inflation fluctuation risk
Inflation generally affects us by increasing our cost of labor and operating expenses. We do not believe that inflation had a material effect on our business, financial condition or results of operations during the three and nine months ended September 30, 2024. Although we do not believe that inflation has had a material impact on our financial position or results of operations to date, we may experience some effect in the near future (especially if inflation rates continue to rise) due to an impact on the costs to conduct clinical trials, labor costs we incur to attract and retain qualified personnel, and other operational costs, inflationary costs could adversely affect our business, financial condition and results of operations.
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ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
As required by Rule 13a-15(b) of the Securities Exchange Act of 1934, as amended, or the Exchange Act, our management, including our principal executive officer and our principal financial officer, conducted an evaluation as of the end of the period covered by this Quarterly Report on Form 10-Q of the effectiveness of the design and operation of our disclosure controls and procedures. Based on that evaluation, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures are effective at the reasonable assurance level in ensuring that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reporting within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by us in the reports we file under the Exchange Act is accumulated and communicated to our management, including our principal executive officer, as appropriate to allow timely decisions regarding required disclosure.
Changes in Internal Control
There were no changes during the period covered by this Quarterly Report on Form 10-Q that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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PART II. OTHER INFORMATION
Item 1. Legal Proceedings
We are not a party to any material legal proceedings at this time. From time to time, we may be subject to various legal proceedings and claims, which may have a material adverse effect on our financial position or results of operations.
Item 1A. Risk Factors
There have been no material changes to the risk factors described in the section captioned “Part I, Item 1A. Risk Factors” in our annual report on Form 10-K for the year ended December 31, 2023. In addition to the other information set forth in this report, you should carefully consider the factors discussed in the section captioned “Part I, Item 1A. Risk Factors” in our annual report on Form 10-K for the year ended December 31, 2023, which could materially affect our business, financial condition, or future results. The risks described in our annual report on Form 10-K and our quarterly reports on Form 10-Q are not the only risks we face. Additional risks and uncertainties not currently known to us or that we currently deem to be immaterial also may have a material adverse effect on our business, financial condition, and/or operating results.
Item 2. Unregistered Sale of Equity Securities and Use of Proceeds
None
Item 3. Defaults Upon Senior Securities
None
Item 4. Mine Safety Disclosures
None
Item 5. Other Information
From time to time, our officers (as defined in Rule 16a–1(f)) and directors may enter into Rule 10b5-1 or non-Rule 10b5-1 trading arrangements (as each such term is defined in Item 408 of Regulation S-K). During the three months ended September 30, 2024, our officers and directors took the following actions with respect to 10b5-1 trading arrangements:
On September 13, 2024, Jessica Snow, our Senior Vice President of Quality and Head of Operations, adopted a Rule 10b5-1 trading plan, which is intended to satisfy the affirmative defense conditions of Exchange Act Rule 10b5-1(c), with respect to the sale of up to an aggregate of 48,089 shares of common stock of the Company pursuant to the terms of such trading plan. Her Rule 10b5-1 trading arrangement is active through October 13, 2025.
Cover Page Interactive Data File (formatted as inline XBRL with applicable taxonomy extension information contained in Exhibits 101.*)
________________
* Filed herewith.
**The certifications furnished in Exhibit 32.1 hereto are deemed to accompany this Quarterly Report on Form 10-Q and will not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended. Such certifications will not be deemed to be incorporated by reference into any filings under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except to the extent that the Registrant specifically incorporates it by reference.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly authorized.
2seventy bio, Inc.
Date: November 12, 2024
By:
/s/ William Baird
William Baird
President and Chief Executive Officer (Principal Executive Officer and Duly Authorized Officer)
Date: November 12, 2024
By:
/s/ Victoria Eatwell
Victoria Eatwell
Chief Financial Officer (Principal Financial and Accounting Officer)