11/13/2025 | Press release | Distributed by Public on 11/13/2025 06:36
Management's discussion and analysis of financial condition and results of operations
The following discussion and analysis should be read in conjunction with our financial statements and accompanying notes included in this Quarterly Report on Form 10-Q and the financial statements and accompanying notes thereto for the fiscal year ended December 31, 2024 and the related Management's Discussion and Analysis of Financial Condition and Results of Operations, which are contained in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (the "SEC") on March 19, 2025 (the "Annual Report"). This Quarterly Report on Form 10-Q contains "forward-looking statements" within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act. Such forward-looking statements, which represent our intent, belief, or current expectations, involve risks and uncertainties and other factors that could cause actual results and the timing of certain events to differ materially from future results expressed or implied by such forward-looking statements. In some cases you can identify forward-looking statements by terms such as "may," "will," "expect," "anticipate," "estimate," "intend," "plan," "predict," "potential," "believe," "should" and similar expressions. Factors that could cause or contribute to differences in results include, but are not limited to, those set forth under "Risk Factors" in our Annual Report. Except as required by law, we undertake no obligation to update these forward-looking statements to reflect events or circumstances after the date of this report or to reflect actual outcomes.
Overview
We are a biotechnology company harnessing the power of allogeneic pluripotent stem cell therapies to develop potentially curative cell therapy products for autoimmune diseases and cancer. Our natural killer, or NK, T cell, and beta islet programs are allogeneic, meaning they are derived from healthy donors for use in any patient, rather than being sourced from an individual for their own specific use, as is the case with autologous T cells. As a result, we believe such "off-the-shelf" therapies have the potential to overcome the limitations of first-generation cell therapies by providing readily available treatments more quickly, reliably, at greater scale, and to a broader patient population. What we believe further sets us apart from other allogeneic approaches is our focus on induced pluripotent stem cells, or iPSCs, which possess the unique ability to self-renew indefinitely and differentiate into any cell type, enabling virtually unlimited genetic editing, consistent reproducibility, and scalable manufacturing. We have created a comprehensive, genetically engineered allogeneic cell therapy platform that includes:
| ● | Industry-leading iPSCs and differentiation know-how to generate functional mature cells from iPSCs; |
| ● | Clustered regularly interspaced short palindromic repeats, or CRISPR mediated precision gene editing that allows us to incorporate multiple transgenes and disrupt target genes intended to optimize cell product performance; |
| ● | Sophisticated protein engineering capabilities to develop proprietary next generation chimeric antigen receptors, or CARs; |
| ● | Our proprietary Allo-Evasion™ technology intended to prevent rejection of our cell products by the host immune system, enabling the potential for persistence and re-dosing of therapy; and |
| ● | Cutting-edge manufacturing capabilities intended to drive scale advantages and reduce cost of goods sold, or COGs, while minimizing product development and supply risk. |
We are leveraging our expertise in cellular reprogramming, differentiation, genetic engineering, and manufacturing to develop therapies with the potential to provide enhanced clinical outcomes compared to existing cell therapy technologies and available therapeutic options. We are unique in the breadth of cell types we can generate from iPSCs, including iPSC-derived natural killer cells, or iNK cells, iPSC-derived gd T cells, or gd IT cells and iPSC-derived CD4+ and CD8+ ab T cells, or ab iT cells, and iPSC-derived beta islet cells. We believe this capability enables optimal matching of cell characteristics to disease indication, ensuring we target the right cell for the right indication.
Our vision is to become a premier, fully integrated biotechnology company by developing and ultimately commercializing off-the-shelf allogeneic cell therapies that dramatically and positively transform the lives of patients suffering from life-threatening autoimmune diseases and cancers. To achieve our vision, our world-class team is applying its decades of collective experience in cell therapy and drug development, manufacturing, and commercialization.
In November 2025, we announced our plans to develop a beta islet program, CNTY-813, for Type 1 diabetes, or T1D. We are leveraging our deep expertise in selective iPSC differentiation to advance this program, engineered with Allo-Evasion™ 5.0, toward clinical evaluation subject to regulatory clearance. Based on our current timelines and expectations, we are poised to move CNTY-813 into IND-enabling studies by the end of 2025. We anticipate submission of an IND as early as 2026.
We also continue to make progress with IND-enabling studies for CNTY-308, a CD19-targeted CD4+/CD8+ ab CAR-iT cell therapy functionally comparable to primary T cells and engineered with Allo-Evasion™ 5.0. CNTY-308 is being developed as a potential treatment for B-cell-mediated diseases. Following successful completion of these IND-enabling studies, and the receipt of requisite regulatory approval, we expect to initiate clinical studies in 2026.
In November 2025, we announced that we will prioritize clinical development activities for CNTY-101, a CAR-iNK cell therapy with six precision gene edits, in CARAMEL, a Phase 1/2 investigator sponsored trial, or IST, which is currently enrolling and dosing patients living with B-cell-mediated autoimmune diseases, led by Professors Georg Schett and Andreas Mackensen and is sponsored by the Friedrich-Alexander University Erlangen-Nürnberg. Accordingly, we discontinued our company-sponsored clinical activities under the CALiPSO-1 trial and will redirect these resources to other programs. Investigators of the CARAMEL IST are expected to present initial data in December 2025.
In July 2025, we completed a reduction in force by approximately 51% of our workforce as part of a broader effort to right size the organization to focus on clinical execution of key programs.
Based on our current business plans, we believe our cash, cash equivalents and investments as of September 30, 2025, will be sufficient for us to fund our operating expenses and capital expenditures requirements into the fourth quarter of 2027. 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. We anticipate that our expenses and operating losses will increase substantially over the foreseeable future. The expected increase in expenses will be driven in large part by our ongoing activities, if and as we:
| ● | continue to advance our iPSC cell therapy platforms; |
| ● | progress preclinical and clinical development of our product candidates; |
| ● | seek to discover and develop additional product candidates; |
| ● | expand and validate our own clinical-scale current good manufacturing practices, or cGMP, facilities; |
| ● | seek regulatory approvals for any of our product candidates that successfully complete clinical trials; |
| ● | maintain, expand, protect, and enforce our intellectual property portfolio; |
| ● | continue to incur costs associated with operating as a public company; |
| ● | acquire or in-license other product candidates and technologies; |
| ● | incur additional costs associated with operating as a public company, which will require us to add operational, financial and management information systems and personnel, including personnel to support our drug development and any future commercialization efforts; and |
| ● | increase our employee headcount and related expenses to support these activities. |
We are also investing in building our capabilities in key areas of manufacturing sciences and operations, including development of our iPSC cell therapy platforms, product characterization, and process analytics from the time product candidates are in early research phases. Our investments also include scaled research solutions, scaled infrastructure, and novel technologies intended to improve efficiency, characterization, and scalability of manufacturing.
We anticipate that we will need to raise additional financing in the future to fund our operations, including funding for preclinical studies, clinical trials and the commercialization of any approved product candidates. We intend to use the proceeds from such financings to, among other uses, fund research and development of our product candidates and development programs. Until such time, if ever, as we can generate significant product revenue, we expect to finance our operations with our existing cash and cash equivalents, investments, any future equity or debt financings, and upfront and milestone and royalty payments, if any, received under future licenses or collaborations. We may not be able to raise additional capital on terms acceptable to us or at all. If we are unable to raise additional capital when desired, our business, results of operations, and financial condition would be adversely affected. Because of the numerous risks and uncertainties associated with product development, we are unable to predict the timing or amount of increased expenses or when or if we will be able to achieve or maintain profitability.
License and collaboration agreements
Bristol-Myers Squibb
On January 7, 2022, we entered into a Research, Collaboration and License Agreement with Bristol-Myers Squibb Company to collaborate on the research, development and commercialization of induced pluripotent stem cell derived, engineered natural killer cell and/or gamma delta T cell programs for hematologic malignancies, initially focused on acute myeloid leukemia, and multiple myeloma, or the Collaboration Agreement.
Under the terms of the Collaboration Agreement, Bristol-Myers Squibb made a non-refundable, upfront cash payment of $100 million and purchased 2,160,760 shares of our common stock at a price per share of $23.14, for an aggregate purchase price of $50.0 million.
Following an internal corporate portfolio prioritization process, Bristol-Myers Squibb notified the Company on December 12, 2024 that it would be terminating the Collaboration Agreement in its entirety without cause. The termination was effective as of March 12, 2025.
Fujifilm Cellular Dynamics, Inc. (FCDI)
On September 18, 2018, we entered into a license agreement, or the Differentiation License, with FCDI. The Differentiation License, as amended, provides us with an exclusive license under certain patents and know-how related to human iPSC consisting of cells that are or are modifications of NK cells, T cells, dendritic cells and macrophages derived from human iPSC. In consideration for the Differentiation License, FCDI received 2,980,803 shares of common stock in connection with the January 2023 Strategic Reprioritization.
Also on September 18, 2018, we entered into the non-exclusive license, or the Reprogramming License, with FCDI. The Reprogramming License, as amended, provides us with a non-exclusive license under certain patents and know-how related to the reprogramming of human somatic cells to iPSCs and provide us access to iPSC lines for clinical use. Under the Reprogramming License, we are required to make certain developmental and regulatory milestone payments as well as royalty payments upon commercialization in the low single digits. In connection with the Reprogramming License, we entered into a collaboration agreement, or the FCDI Collaboration Agreement, with FCDI pursuant to which we agreed to fund research and development work at FCDI pursuant to a research plan.
On October 21, 2019, we entered into the FCDI Collaboration Agreement with FCDI, whereby FCDI provides certain services to us to develop and manufacture iPSCs and immune cells derived therefrom. Under the terms of the FCDI Collaboration Agreement, as amended, FCDI will provide services in accordance with the approved research plan and related research budget. The initial research plan covers the period from the date of execution of the FCDI Collaboration Agreement through March 31, 2022. On July 29, 2022, we amended the FCDI Collaboration Agreement to extend the term through September 30, 2025.
On January 7, 2022, we and FCDI entered into a letter agreement, which amends each of the FCDI agreements as further discussed in Note 14 to our consolidated financial statements. Pursuant to the Letter Agreement, and in consideration for amending the FCDI Agreements, we agreed to pay to FCDI (i) an upfront payment of $10 million, (ii) a percentage of any milestone payments received by us under the Collaboration Agreement, in respect of achievement of development or regulatory milestones specific to Japan, and (iii) a percentage of all royalties received by us under the Collaboration Agreement in respect of sales of products in Japan.
On September 22, 2023, we and FCDI entered into a worldwide license agreement whereby FCDI will grant non-exclusive licenses to us for certain patent rights and know-how related to cell differentiation and reprogramming for the development and commercialization of iPSC-derived therapies for the treatment of inflammatory and autoimmune diseases, or the Autoimmune License. Under the terms of the Autoimmune License, FCDI will be eligible to receive certain development and regulatory milestone payments as well as low single-digit royalties related to products developed in connection with the Autoimmune License. In addition, on September 22, 2023, we and FCDI amended the Reprogramming License, Differentiation License and the Collaboration Agreement to expand our existing license related to the development and commercialization of iPSC-derived cancer immunotherapeutic to also include inflammatory and autoimmune diseases.
During the three and nine months ended September 30, 2025, we made payments of $0 and $1.9 million and incurred research and development expenses of $0 and $1.9 million recorded within general and administrative expenses in its consolidated statements of operations and comprehensive income (loss), respectively.
During the three and nine months ended September 30, 2024, we made payments of $3.7 million and $6.6 million and incurred research and development expenses of $981 thousand and $5.2 million and legal fees of $38 thousand and $73 thousand, recorded within general and administrative expenses in its consolidated statements of operations and comprehensive loss.
From inception of the FCDI Collaboration Agreement through September 30, 2025, we incurred $44.7 million of expenses under the FCDI Collaboration Agreement.
Components of operating results
Collaboration revenue
We have not generated any revenue from product sales and do not expect to generate any revenue from the sale of products for the foreseeable future. Our revenues to date were generated through our collaboration, option and license agreement with Bristol-Myers Squibb, which was terminated, effective as of March 12, 2025. We recognize revenue over the expected performance period under this agreement. We expect that our revenue for the next several years will be derived primarily from any collaborations that we may enter into in the future. To date, we have not received any royalties under any of our existing collaboration agreements.
Operating expenses
Research and development
To date, research and development expenses have related primarily to discovery and development of our iPSC cell therapy platform technology and product candidates and acquired in-process research and
development. Research and development expenses are recognized as incurred and payments made prior to the receipt of goods or services to be used in research and development are recorded as prepaid expenses until the goods or services are received.
Research and development expenses consist of personnel-related costs, including salaries, and benefits, stock compensation expense, external research and development expenses incurred under arrangements with third parties, laboratory supplies, costs to acquire and license technologies facility and other allocated expenses, including rent, depreciation, and allocated overhead costs, and other research and development expenses.
We deploy our employee and infrastructure resources across multiple research and development programs for developing our iPSC cell therapy platforms, identifying and developing product candidates, and establishing manufacturing capabilities. Due to the number of ongoing projects and our ability to use resources across several projects, the vast majority of our research and development costs are not recorded on a program-specific basis. These include costs for personnel, laboratory, and other indirect facility and operating costs.
Research and development activities account for a significant portion of our operating expenses. We anticipate that our research and development expenses will increase for the foreseeable future as we expand our research and development efforts including expanding the capabilities of our iPSC cell therapy platforms, identifying product candidates, progressing preclinical studies and clinical trials, including for our first clinical product candidate CNTY-101, seeking regulatory approval of our product candidates, and incurring costs to acquire and license technologies aligned with our goal of translating iPSCs to therapies. A change in the outcome of any of these variables could mean a significant change in the costs and timing associated with the development of our product candidates.
General and administrative
General and administrative expenses consist of personnel-related costs, including salaries, benefits, and non-cash stock-based compensation, for our employees in executive, legal, finance, human resources, information technology, and other administrative functions, legal fees, consulting fees, recruiting costs, and facility costs not otherwise included in research and development expenses. Legal fees include those related to corporate and patent matters.
Impairment of long-lived assets
We review our amortizable long lived assets for impairment when impairment indicators exist by comparing the carrying values of the assets with their estimated future undiscounted cash flows. If the carrying value exceeds the estimated future undiscounted cash flows, the Company calculates an impairment charge based on the difference between asset carrying values and fair value of discounted cash flows, which are based on indicative fair market quotes and are considered level three fair value estimates. We incurred $6.76 million in impairment during the three and nine months ended September 30, 2025. There were no impairment charges incurred in 2024.
Interest income
Interest income consists of interest earned on our cash, cash equivalents and investment balances.
Income taxes
We have evaluated the positive and negative evidence bearing upon its ability to realize our deferred tax assets, which primarily consist of net operating loss carryforwards. While we utilized a portion of its existing net operating loss carryforwards during tax year 2023, we have considered its history of cumulative net losses in the U.S., estimated future taxable income and prudent and feasible tax planning strategies and have concluded that it is more likely than not that we will not realize the benefits of our U.S. deferred tax assets. As a result, as of September 30, 2025, we have recorded a full valuation allowance against our net deferred tax assets, exclusive of our deferred tax liability on IPR&D in the U.S.
Results of operations
Comparison of the three months ended September 30, 2025 and 2024.
The following table summarizes our results of operations for the periods presented:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Three Months Ended |
|
|
|
|
||
|
|
|
September 30, 2025 |
|
September 30, 2024 |
|
Change |
|
|||
|
|
|
(in thousands) |
|
|||||||
|
Collaboration revenue |
|
$ |
- |
|
$ |
791 |
|
$ |
(791) |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
||
|
Research and development |
|
22,526 |
|
27,228 |
|
(4,702) |
|
|||
|
General and administrative |
|
6,835 |
|
8,352 |
|
(1,517) |
|
|||
|
Impairment of long-lived assets |
|
6,763 |
|
- |
|
6,763 |
|
|||
|
Total operating expenses |
|
36,124 |
|
35,580 |
|
544 |
|
|||
|
Loss from operations |
|
(36,124) |
|
(34,789) |
|
(1,335) |
|
|||
|
Other income: |
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
1,605 |
|
|
3,305 |
|
|
(1,700) |
|
|
Other income, net |
|
97 |
|
250 |
|
(153) |
|
|||
|
Total other income |
|
|
1,702 |
|
|
3,555 |
|
|
(1,853) |
|
|
Loss before provision for income taxes |
|
|
(34,422) |
|
|
(31,234) |
|
|
(3,188) |
|
|
Provision for income taxes |
|
|
- |
|
|
8 |
|
|
(8) |
|
|
Net loss |
|
$ |
(34,422) |
|
$ |
(31,226) |
|
$ |
(3,196) |
|
Collaboration revenue
During the three months ended September 30, 2025 and 2024, we recognized revenue of $0 million and $0.8 million under our collaboration agreement with Bristol-Myers Squibb, respectively. See Note 7 to our consolidated financial statements for additional information. The Collaboration Agreement was terminated, effective as of March 12, 2025. As such, we recognized the remaining transaction price of $109.2 million as collaboration revenue during the three months ended March 31, 2025. There will be no future collaboration revenues recognized under this collaboration agreement.
Research and development expenses
The following table summarizes the components of our research and development expenses for the periods presented:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Three Months Ended |
|
|
|
||
|
|
|
September 30, 2025 |
|
September 30, 2024 |
|
Change |
|||
|
|
|
|
(in thousands) |
||||||
|
Personnel and related costs |
$ |
8,344 |
$ |
11,056 |
$ |
(2,712) |
|||
|
Facility and other allocated costs |
|
6,194 |
|
5,502 |
|
692 |
|||
|
Research and laboratory |
|
7,315 |
|
7,098 |
|
217 |
|||
|
Other |
|
673 |
|
3,572 |
|
(2,899) |
|||
|
Total research and development expense |
|
$ |
22,526 |
|
$ |
27,228 |
|
$ |
(4,702) |
Research and development expenses were $22.5 million and $27.2 million for the three months ended September 30, 2025 and 2024, respectively. The decrease of $4.7 million was primarily due to:
| ● | a decrease in personnel and related costs of $2.7 million due to a reduction in research and development staff. |
| ● | a decrease in other costs of $2.9 million primarily due to the completion of our CNTY-101 product candidate manufacturing campaign performed under our collaboration agreement with FCDI. |
| ● | these decreases were offset by an an increase in facility and other allocated costs of $0.7 million due to an increase in facilities services and maintenance. |
General and administrative expenses
General and administrative expenses were $6.8 million and $8.4 million for the three months ended September 30, 2025 and 2024, respectively. This decrease was due to a decrease in legal fees associated with the Clade acquisition in 2024, a decrease in stock-based compensation, as well as a gain on lease modification. These decreases were offset by an increase in severance costs, contingent liability consideration and the consolidation of lab operations and subsequent reallocation of rent expense to G&A.
Impairment of long-lived assets
Impairment of long-lived assets was $6.8 million and $0 for the three months ended September 30, 2025 and 2024, respectively. This increase was due to an impairment charge taken on a portion of the Company's Philadelphia headquarters.
Interest income
Interest income was $1.6 million and $3.3 million for the three months ended September 30, 2025 and 2024, respectively, which related to interest earned on our cash, cash equivalents, and investment balances.
Results of operations
Comparison of the nine months ended September 30, 2025 and 2024.
The following table summarizes our results of operations for the periods presented:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
Nine Months Ended |
|
|
|
||
|
|
|
September 30, 2025 |
|
September 30, 2024 |
|
Change |
|||
|
|
|
|
(in thousands) |
||||||
|
Collaboration revenue |
|
$ |
109,164 |
|
$ |
2,416 |
|
$ |
106,748 |
|
Operating expenses: |
|
|
|
|
|
|
|
||
|
Research and development |
|
75,972 |
|
77,869 |
|
|
(1,897) |
||
|
General and administrative |
|
23,047 |
|
25,400 |
|
(2,353) |
|||
|
Impairment of long-lived assets |
|
6,763 |
|
|
- |
|
|
6,763 |
|
|
Total operating expenses |
|
105,782 |
|
103,269 |
|
2,513 |
|||
|
Income (loss) from operations |
|
3,382 |
|
(100,853) |
|
104,235 |
|||
|
Other income: |
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
6,037 |
|
|
10,126 |
|
|
(4,089) |
|
Other income, net |
|
|
172 |
|
|
248 |
|
|
(76) |
|
Total other income |
|
|
6,209 |
|
|
10,374 |
|
|
(4,165) |
|
Income (loss) before provision for income taxes |
|
|
9,591 |
|
|
(90,479) |
|
|
100,070 |
|
Provision for income taxes |
|
|
- |
|
|
(14) |
|
|
14 |
|
Net income (loss) |
|
$ |
9,591 |
|
$ |
(90,493) |
|
$ |
100,084 |
Collaboration revenue
During the nine months ended September 30, 2025 and 2024, we recognized revenue of $109.2 million and $2.4 million under our collaboration agreement with Bristol-Myers Squibb, respectively. See Note 7 to our consolidated financial statements for additional information. The Collaboration Agreement was terminated, effective as of March 12, 2025. As such, we recognized the remaining transaction price of $109.2 million as collaboration revenue during the six months ended June 30, 2025. There will be no future collaboration revenues recognized under this collaboration agreement.
Research and development expenses
The following table summarizes the components of our research and development expenses for the periods presented:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
Nine Months Ended |
|
|
|
|
||
|
|
|
September 30, 2025 |
|
September 30, 2024 |
|
Change |
|
|||
|
|
|
|
(in thousands) |
|
||||||
|
Personnel and related costs |
$ |
28,043 |
$ |
31,757 |
$ |
(3,714) |
|
|||
|
Facility and other allocated costs |
|
17,041 |
|
16,738 |
|
303 |
|
|||
|
Research and laboratory |
|
27,285 |
|
22,221 |
|
5,064 |
|
|||
|
Other |
|
3,603 |
|
7,153 |
|
(3,550) |
|
|||
|
Total research and development expense |
|
$ |
75,972 |
|
$ |
77,869 |
|
$ |
(1,897) |
|
Research and development expenses were $76.0 million and $77.9 million for the nine months ended September 30, 2025 and 2024, respectively. The decrease of $1.9 million was primarily due to:
| ● | a decrease in personnel and related costs of $3.7 million due to a reduction in research and development staff. |
| ● | a decrease in collaboration costs of $3.6 million primarily due to the completion of our CNTY-101 product candidate manufacturing campaign performed under our collaboration agreement with FCDI. |
| ● | the above decreases were offset by an increase in research and laboratory costs of $5.1 million due to progression of CALiPSO-1 and CNTY-308. |
General and administrative expenses
General and administrative expenses were $23.0 million and $25.4 million for the nine months ended September 30, 2025 and 2024, respectively. The decrease was a result of a decrease in legal fees associated with the Clade acquisition in 2024, a gain on lease modification and a decrease in stock-based compensation, offset by increased severance costs, contingent liability consideration and the consolidation of lab operations and subsequent reallocation of rent expense to general and administrative expenses.
Impairment of long-lived assets
Impairment of long-lived assets was $6.8 million and $0 for the nine months ended September 30, 2025 and 2024, respectively. This increase was due to an impairment charge taken on a portion of our Philadelphia headquarters.
Interest income
Interest income was $6.0 million and $10.1 million for the nine months ended September 30, 2025 and 2024, respectively, which related to interest earned on our cash, cash equivalents, and investment balances.
Liquidity, capital resources, and capital requirements
Sources of liquidity
To date, we have funded our operations from the issuance and sale of our equity securities, debt financing and collaboration revenues. Since our inception, we have raised approximately $666 million in net proceeds from the sales of our equity securities. As of September 30, 2025, we had cash, and cash equivalents of $55.5 million and investments of $77.2 million. Based on our research and development plans, we believe our existing cash, cash equivalents and investments, will be sufficient to fund our operating expenses and capital expenditures requirements into the fourth quarter of 2027. Since our inception, we have incurred significant operating losses. We have not yet commercialized any products and we do not expect to generate revenue from sales of any product candidates for a number of years, if ever. We had an accumulated deficit of $772.7 million as of September 30, 2025.
In July 2022, we entered into a Sales Agreement, with Cowen and Company, LLC or Cowen, under which we may offer and sell, from time to time in our sole discretion, shares of our common stock, having an aggregate offering price of up to $150 million through Cowen as sales agent. In February of 2024, 4,084,502 shares of common stock were issued and sold pursuant to the Sales Agreement at a weighted-average price of $4.50 per share, resulting in approximately $18.4 million in gross proceeds.
In April 2024, we entered into a securities purchase agreement or, the Securities Purchase Agreement, with certain institutional accredited investors, or the Investors, pursuant to which we agreed to issue and sell to the Investors in a private placement an aggregate of 15,873,011 shares of common stock, or the Private Placement Shares, at a price of $3.78 per share, or the Private Placement. We received aggregate gross proceeds from the Private Placement of approximately $60 million, before deducting placement agent fees and offering expenses.
Future funding requirements
We expect to incur additional losses in the foreseeable future as we conduct and expand our research and development efforts, including conducting preclinical studies and clinical trials, developing new product candidates, establishing internal and external manufacturing capabilities, and funding our operations generally. We anticipate that we will need to raise additional financing in the future to fund our operations, including the commercialization of any approved product candidates. We are subject to the risks typically
related to the development of new products, and we may encounter unforeseen expenses, difficulties, complications, delays, and other unknown factors that may adversely affect our business.
Our future capital requirements will depend on many factors, including:
| ● | the scope, timing, progress, costs, and results of discovery, preclinical development, and clinical trials for our current and future product candidates; |
| ● | the number of clinical trials required for regulatory approval of our current and future product candidates; |
| ● | the costs, timing, and outcome of regulatory review of any of our current and future product candidates; |
| ● | the cost of manufacturing clinical and commercial supplies of our current and future product candidates; |
| ● | the costs and timing of future commercialization activities, including manufacturing, marketing, sales, and distribution, for any of our product candidates for which we receive marketing approval; |
| ● | the costs and timing of preparing, filing, and prosecuting patent applications, obtaining, maintaining, protecting, and enforcing our intellectual property rights, and defending any intellectual property-related claims, including any claims by third parties that we are infringing upon, misappropriating, or violating their intellectual property rights; |
| ● | our ability to maintain existing, and establish new, strategic collaborations, licensing, or other arrangements and the financial terms of any such agreements, including the timing and amount of any future milestone, royalty, or other payments due under any such agreement; |
| ● | the revenue, if any, received from commercial sales of our product candidates for which we receive marketing approval; |
| ● | expenses to attract, hire and retain, skilled personnel; |
| ● | costs of operating as a public company; |
| ● | our ability to establish a commercially viable pricing structure and obtain approval for coverage and adequate reimbursement from third-party and government payors; |
| ● | the effect of competing technological and market developments; and |
| ● | the extent to which we acquire or invest in businesses, products, and technologies. |
Until and unless we can generate substantial product revenue, we expect to finance our cash needs through the proceeds from a combination of equity offerings and debt financings, and potentially through additional license and development agreements or strategic partnerships or collaborations with third parties. Financing may not be available in sufficient amounts or on reasonable terms. In addition, market volatility resulting from the effects of pandemics, inflationary pressures, disruptions of financial institutions, political unrest and hostilities, war or other factors could adversely impact our ability to access capital as and when needed. We have no commitments for any additional financing and will likely be required to raise such financing through the sale of additional securities, which, in the case of equity securities, may occur at prices lower than the offering price of our common stock. If we sell equity or equity-linked securities, our current stockholders, may be diluted, and the terms may include liquidation or other preferences that are senior to or otherwise adversely affect the rights of our stockholders. Moreover, if we issue debt, we may need to dedicate a substantial portion of our operating cash flow to paying principal and interest on such debt and we may need to comply with operating restrictions, such as limitations on incurring additional debt, which could impair our ability to acquire, sell or license intellectual property rights which could impede our ability to conduct our business.
Cash flows
The following table summarizes our cash flows for the periods indicated:
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Nine months ended |
Nine months ended |
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September 30, 2025 |
September 30, 2024 |
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(in thousands) |
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Net cash (used in) provided by: |
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Operating activities |
$ |
(87,799) |
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$ |
(85,912) |
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Investing activities |
85,140 |
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16,876 |
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Financing activities |
120 |
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75,165 |
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Net decrease in cash, cash equivalents, and restricted cash |
$ |
(2,539) |
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$ |
6,129 |
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Operating activities
Net cash used in operating activities was $87.8 million and $85.9 million for the nine months ended September 30, 2025 and 2024, respectively. Net cash used in operating activities during the nine months ended September 30, 2025 consisted primarily of our net income of $9.6 million and non-cash charges of $23.1 million, offset by a decrease of $120.5 million in our net operating assets and liabilities. The non-cash charges of $23.1 million consisted primarily of $9.6 million for depreciation expense, non-cash operating lease expense of $1.5 million, and stock-based compensation expense of $5.5 million, impairment of long-lived asset of $6.8 million, gain on reduction in lease liability due to lease termination of $1.4 million, and gain on contingent consideration liability of $0.4 million, partially offset by amortization of marketable securities of $2.0 million. The change in operating assets and liabilities was primarily due to a $3.6 million decrease in operating lease liability, a $109.2 million decrease in deferred revenue due to the termination of the Collaboration Agreement with Bristol-Myers Squibb, and an $8.2 million decrease in accrued expenses.
Net cash used in operating activities during the nine months ended September 30, 2024 consisted primarily of our net loss of $90.5 million and a decrease of $11.1 million in our net operating assets and liabilities, partially offset by non-cash charges of $15.7 million. The non-cash charges of $15.7 million consisted primarily of $10.0 million for depreciation expense, non-cash operating lease benefit of $0.4 million, a decrease in lease liability due to lease termination, and stock-based compensation expense of $10.0 million, partially offset by amortization of marketable securities of $3.8 million and gain on contingent consideration liability of $1.1 million. The change in operating assets and liabilities was primarily due to a $2.9 million increase in prepaid expenses and other assets, a $2.6 million decrease in operating lease liability, a $2.4 million decrease in deferred revenue, and a $1.9 million decrease in accounts payable.
Investing activities
Net cash provided by investing activities was $85.1 million and $16.9 million for the nine months ended September 30, 2025 and 2024, respectively. Cash provided by investing activities for the nine months ended September 30, 2025 consisted primarily of the sale of fixed maturity securities of $121.7 million, which was partially offset by purchases of fixed maturity securities of $35.6 million.
Net cash provided by investing activities was $16.9 million for the nine months ended September 30, 2024. Cash provided by investing activities for the nine months ended September 30, 2024 consisted primarily of the sale of fixed maturity securities, available for sale of $128.6 million, which was partially offset by purchases of fixed maturity securities of $102.1 million, and the acquisition of Clade of $9.6 million.
Financing activities
Net cash provided by financing activities was $0.1 million and $75.2 million for the nine months ended September 30, 2025 and 2024, respectively. Cash provided by financing activities consisted of $0.1 million from issuance of our common stock from equity incentive plans pursuant to the exercise of employee stock options.
Net cash provided by financing activities was $75.2 million for the nine months ended September 30, 2024. Cash provided by financing activities consisted of $17.8 million from proceeds from our at-the-market capital raise, $56.6 million from proceeds from our PIPE financing, and $0.7 million from issuance of our common stock from equity incentive plans pursuant to the exercise of employee stock options.
Contractual obligations and commitments
The following table summarizes our significant contractual obligations and commitments as of September 30, 2025:
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Payments Due by Period |
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1 Year |
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1 to 3 Years |
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3 to 5 Years |
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More than 5 Years |
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Total |
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(in thousands) |
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Operating leases |
$ |
7,988 |
$ |
14,849 |
$ |
15,611 |
$ |
27,951 |
$ |
66,399 |
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When our lease in Watertown, MA commences in 2026, it will add approximately $7.3 million to our future operating lease commitments
Payment obligations under our license, collaboration, and acquisition and merger agreements as of September 30, 2025 are contingent upon future events such as our achievement of pre-specified development, regulatory, and commercial milestones, or royalties on net product sales. As of September 30, 2025, the timing and likelihood of achieving the milestones and success payments and generating future product sales are uncertain and therefore, any related payments are not included in the table above. We also enter into agreements in the normal course of business for sponsored research, preclinical studies, contract manufacturing, and other services and products for operating purposes, which are generally cancelable upon written notice. These obligations and commitments are not included in the table above. See Note 8 "Commitments and contingencies" for additional information.
We have commitments under operating leases for certain facilities used in our operations.
JOBS Act accounting election
As a company with less than $1.235 billion in revenue during our last fiscal year, we qualify as an "emerging growth company" as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. An emerging growth company may take advantage of specified reduced reporting requirements that are otherwise generally applicable to public companies. As such, we may take advantage of reduced disclosure and other requirements otherwise generally applicable to public companies, including:
| ● | not being required to have our registered independent public accounting firm attest to management's assessment of our internal control over financial reporting; |
| ● | presenting reduced disclosure about our executive compensation arrangements; |
| ● | an exemption from compliance with any requirement that the Public Company Accounting Oversight Board may adopt regarding mandatory audit firm rotation or a supplement to the auditor's report providing additional information about the audit and the financial statements; |
| ● | not being required to hold non-binding advisory votes on executive compensation or golden parachute arrangements; and, |
| ● | extended transition periods for complying with new or revised accounting standards. |
The JOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards. This provision allows an emerging growth company to delay the adoption of some accounting standards until those standards would otherwise apply to private companies. We have elected to use the extended transition period to enable us to comply with new or revised accounting standards and, therefore, we will adopt new or revised accounting standards at the time private companies adopt the new or revised accounting 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 will remain an emerging growth company until the earliest of (i) December 31, 2026, (ii) the last day of the fiscal year in which we have total annual gross revenue of at least $1.235 billion, (iii) the last day of the fiscal year in which we are deemed to be a "large accelerated filer" as defined in Rule 12b-2 under the Exchange Act, which would occur if the market value of our common stock held by non-affiliates exceeded $700.0 million as of the last business day of the second fiscal quarter of such year or (iv) the date on which we have issued more than $1.0 billion in non-convertible debt securities during the prior three-year period.
We are also a "smaller reporting company," meaning that the market value of our stock held by non-affiliates is less than $700.0 million and our annual revenue is less than $100.0 million during the most recently completed fiscal year. We may continue to be a smaller reporting company if either (i) the market value of our stock held by non-affiliates is less than $250.0 million or (ii) our annual revenue is less than $100.0 million during the most recently completed fiscal year and the market value of our stock held by non-affiliates is less than $700.0 million as of the last business day of the second fiscal quarter of such year. If we are a smaller reporting company at the time we cease to be an emerging growth company, we may continue to rely on exemptions from certain disclosure requirements that are available to smaller reporting companies. Specifically, as a smaller reporting company we may choose to present only the two most recent fiscal years of audited financial statements in our Annual Report on Form 10-K and, similar to emerging growth companies, smaller reporting companies have reduced disclosure obligations regarding executive compensation.
Critical accounting policies and significant judgments and estimates
Refer to Note 2, Summary of Significant Accounting Policies, included in Part I, Item 1 of this Quarterly Report on Form 10-Q for a discussion of our critical accounting policies.
During the nine months ended September 30, 2025, there were no material changes to our critical accounting policies from those described in our audited financial statements for the year ended December 31, 2024 included in our Annual Report on Form 10-K filed with the SEC on March 19, 2025, except as noted above.