Fulcrum Therapeutics Inc.
10/29/2025 | Press release | Distributed by Public on 10/29/2025 05:11
Quarterly Report for Quarter Ending September 30, 2025 (Form 10-Q)
Management's Discussion and Analysis ofFinancial Condition and Results of Operations.
The following discussion and analysis of our financial condition and results of operations should be read together with our consolidated financial statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q and our Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC, on February 25, 2025. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report on Form 10-Q, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in the "Risk Factors" section of this Quarterly Report on Form 10-Q, our actual results could differ materially from the results described in, or implied by, the forward-looking statements contained in the following discussion and analysis. See "Cautionary Note Regarding Forward-Looking Statements."
Overview
We are a clinical-stage biopharmaceutical company focused on developing small molecules to improve the lives of patients with genetically defined rare diseases in areas of high unmet medical need. Our clinical-stage product candidate, pociredir, is being developed for the potential treatment of sickle cell disease, or SCD.
In July 2025, we announced results from the 12 mg dose cohort of our Phase 1b trial of pociredir in SCD, following conclusion of the 12-week treatment period (n=16). Results are as follows:
•
Mean absolute fetal hemoglobin, or HbF, increased by 8.6% at 12 weeks of treatment with pociredir, representing an increase from a baseline of 7.6% to 16.2%. Seven of 16 patients achieved absolute HbF levels greater than 20% after 12 weeks of treatment with pociredir. HbF levels of 20% are associated with approximately 90% of individual patients experiencing zero vaso-occlusive crises, or VOCs, per year, based on an analysis of real-world data we conducted that was presented at the 20th Annual Sickle Cell & Thalassaemia Conference (ASCAT) in October 2025.
•
Proportion of F-cells (HbF-containing red blood cells) increased from a mean of 34% at baseline to 67% at 12 weeks of treatment (n=8), consistent with pan-cellular HbF induction (evenly distributed across red blood cells). F-cells are resistant to red blood cell sickling and hemolysis because of HbF-mediated inhibition of sickle hemoglobin polymerization. Consequently, a higher proportion of F-cells is associated with improved red blood cell health.
•
Markers of hemolysis and erythropoiesis improved with pociredir treatment at 12 weeks:
o
Decreased indirect bilirubin (mean decrease of 37%)
o
Decreased lactate dehydrogenase (mean decrease of 28%)
o
Decreased red cell distribution width (mean decrease of 27%), indicating a more uniform red blood cell population
o
Decreased reticulocyte counts (mean decrease of 30%), indicating healthier bone marrow function
•
Mean hemoglobin concentration increased by 0.9 g/dL at 12 weeks of treatment with pociredir, from a baseline of 7.8 g/dL to 8.7 g/dL. Together with the observed decrease in reticulocyte counts, the increase in total hemoglobin indicates that pociredir decreased red blood cell destruction and showed reductions in anemia.
•
A trend of reduced VOC rates was observed during the study period (as assessed by VOCs reported as adverse events, or AEs), compared to cohort patients' VOC frequency over the 6-12 months prior to enrollment. Eight of 16 patients (50%) reported no VOCs during the treatment period (12 weeks); three VOCs occurred during the follow-up period as of the June 26, 2025 data cut-off date.
•
Through the completion of the 12 mg dose cohort, pociredir has been dosed in 135 adults, including 76 subjects in multiple dose cohorts up to 12 weeks.
o
103 healthy subjects, including 44 who received pociredir from 10 to 14 days treatment duration
o
32 SCD patients who received pociredir up to 12 weeks treatment duration
•
The safety profile for pociredir observed in the 12 mg dose cohort was consistent with previously reported safety data. Pociredir was generally well-tolerated, with no drug-related serious adverse events and no discontinuations due to treatment-emergent adverse events through the completion of the 12 mg dose cohort. In addition, all treatment-related adverse events were Grade 1.
•
Additional observations after completion of the 4-week follow-up period for 12 mg dose cohort (ongoing) will be shared at a future medical meeting.
This 12 mg data (n=16) relates to cohort 3b (incomplete prior 12 mg cohort (3a) conducted prior to clinical study hold not included in this analysis).
We have completed enrollment in the 20 mg dose cohort with 12 patients (excluding 1 discontinuation that was previously disclosed), with greater than 90% rates of adherence to study drug to date, and we expect to provide clinical data from this cohort by the end of 2025. The mean and median baseline HbF levels of the 12 patients enrolled in the 20 mg dose cohort is 7.1% and 7.3%, respectively. We are also initiating an open label extension trial to allow patients to continue receiving pociredir after completing the PIONEER trial, enabling longer-term evaluation of safety and durability of response.
In addition to our product candidates, we developed a discovery approach that we employ to systematically identify and validate cellular drug targets that can potentially modulate gene expression to treat known root causes of genetically defined rare diseases. Our discovery approach led to the identification of pociredir for SCD, as well as other drug candidates. We continue to advance our program for the potential treatment of bone marrow failure syndromes, such as DBA, 5q deletion syndrome, Shwachman-Diamond syndrome, and Fanconi anemia, and we plan to submit an IND during the fourth quarter of 2025. We also presented preclinical data for FTX-6274, an oral embryonic ectoderm development, or EED, inhibitor candidate, at the European Society for Medical Oncology (ESMO) Congress 2025, demonstrating robust efficacy in castration resistant prostate cancer models.
We have incurred significant operating losses since our inception and we expect to continue to incur significant operating losses for the foreseeable future. Our ability to generate product revenue sufficient to achieve profitability, if ever, will depend heavily on the successful development and eventual commercialization of one or more of our product candidates. Our net loss was $54.5 million for the nine months ended September 30, 2025. Our net income was $6.8 million for the nine months ended September 30, 2024, primarily due to the $80.0 million of collaboration revenue associated with our now terminated collaboration and license agreement with Sanofi that we recognized during the second quarter of 2024. As of September 30, 2025, we had an accumulated deficit of $573.9 million. We expect our expenses and operating losses will increase over the next several years in connection with our ongoing activities, as we:
•
continue our clinical development of pociredir;
•
continue our ongoing preclinical studies;
•
advance clinical-stage product candidates into later stage trials;
•
pursue the discovery of drug targets for other genetically-defined rare diseases and the subsequent development of any resulting product candidates, including for the potential treatment of bone marrow failure syndromes, such as DBA, 5q deletion syndrome, Shwachman-Diamond syndrome, and Fanconi anemia under our license agreement with CAMP4;
•
seek regulatory approvals for any product candidates that successfully complete clinical trials;
•
scale up our manufacturing processes and capabilities, or arrange for a third party to do so on our behalf, to support our clinical trials of our product candidates and commercialization of any of our product candidates for which we obtain marketing approval;
•
establish a sales, marketing and distribution infrastructure to commercialize any products for which we may obtain regulatory approval and that we have not out-licensed;
•
acquire or in-license products, product candidates, technologies and/or data referencing rights, such as our agreement with CAMP4;
•
make any milestone payments to CAMP4 under our license agreement;
•
maintain, expand, enforce, defend and protect our intellectual property;
•
hire additional clinical, quality control and scientific personnel; and
•
add operational, financial and management information systems and personnel, including personnel to support our product development and planned future commercialization efforts and our operations as a public company.
As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until such time as we can generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of equity offerings, debt financings, collaborations, strategic alliances and marketing, distribution or licensing arrangements. We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all. If we fail to raise capital or enter into such agreements as, and when, needed, we may have to significantly delay, scale back or discontinue the development and commercialization of one or more of our product candidates, or grant rights to develop and market our product candidates even if we would otherwise prefer to develop and market such product candidates ourselves.
Because of the numerous risks and uncertainties associated with drug development, we are unable to predict the timing or amount of increased expenses or the timing of when or if we will be able to achieve or maintain profitability. Even if we are able to generate product sales, we may not become profitable. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and be forced to reduce or terminate our operations.
As of September 30, 2025, we had $200.6 million in cash, cash equivalents, and marketable securities. We believe that our existing cash, cash equivalents, and marketable securities as of September 30, 2025 will enable us to fund our operating expenses and capital expenditure requirements into 2028. 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. See "-Liquidity and Capital Resources."
Components of Results of Operations
Revenue
We have not generated any revenue from product sales and do not expect to generate revenue from the sale of products for several years, if at all. If our development efforts for our current or future product candidates are successful and result in marketing approval, we may generate revenue in the future from product sales. We cannot predict if, when or to what extent we will generate revenue from the commercialization and sale of our product candidates. We may never succeed in obtaining regulatory approval for any of our product candidates.
In May 2024, we entered into a collaboration and license agreement with Sanofi, pursuant to which we granted Sanofi an exclusive license under certain intellectual property rights to commercialize losmapimod, an oral small molecule for the treatment of facioscapulohumeral muscular dystrophy, or FSHD, outside of the United States and received an upfront payment of $80.0 million.
During the three and nine months ended September 30, 2025, we recorded zero and $1.0 million reduction in research and development expenses, respectively, in connection with global development activities for losmapimod. During the three and nine months ended September 30, 2025, we recognized no revenue associated with the Sanofi territory-specific manufacturing activities for losmapimod. As a result of the suspension of future development of losmapimod following our September 2024 announcement that there was no statistically significant difference between losmapimod and placebo on the primary endpoint in the Phase 3 REACH trial, Sanofi terminated the license. Accordingly, we will not recognize additional revenues under the Sanofi collaboration agreement.
In the future, we may enter into additional license or collaboration agreements for our product candidates or intellectual property, and we may generate revenue in the future from payments as a result of such license or collaboration agreements.
Operating Expenses
Research and Development Expenses
Research and development expenses represent costs incurred by us for the discovery, development, and manufacture of our product candidates and include:
•
external research and development expenses incurred under agreements with contract research organizations, contract manufacturing organizations, and consultants;
•
salaries, payroll taxes, employee benefits and stock-based compensation expenses for individuals involved in research and development efforts;
•
laboratory supplies;
•
costs related to compliance with regulatory requirements; and
•
facilities, depreciation and other allocated expenses, which include direct and allocated expenses for rent, maintenance of facilities, insurance and other operating costs.
We expense research and development costs as incurred. We recognize expenses for certain development activities, such as clinical trials and manufacturing, based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment or other information provided to us by our vendors. Payments for these activities are based on the terms of the individual agreements, which may differ from the pattern of expenses incurred. Non-refundable advance payments for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses. These amounts are recognized as an expense as the goods are delivered or the related services are performed, or until it is no longer expected that the goods will be delivered or the services rendered.
External costs represent a significant portion of our research and development expenses, which we track on a program-by-program basis following the nomination of a development candidate. Our internal research and development expenses consist primarily of personnel-related expenses, including stock-based compensation expense. We do not track our internal research and development expenses on a program-by-program basis as the resources are deployed across multiple projects.
The following table summarizes our external research and development expenses by program for the three and nine months ended September 30, 2025 and 2024. Pre-development candidate expenses, unallocated expenses and internal research and development expenses are classified separately. Payments to or reimbursements from Sanofi related to global development activities are accounted for as an increase to or reduction of losmapimod external expenses.
|
Three Months Ended |
Nine Months Ended |
|||||||||||||||
|
(in thousands) |
2025 |
2024 |
2025 |
2024 |
||||||||||||
|
Pociredir external expenses |
$ |
5,412 |
$ |
2,216 |
$ |
13,769 |
$ |
6,020 |
||||||||
|
Losmapimod external expenses |
169 |
4,308 |
1,104 |
18,783 |
||||||||||||
|
Pre-development candidate expenses and unallocated expenses |
4,698 |
3,520 |
14,371 |
10,524 |
||||||||||||
|
Internal research and development expenses |
4,017 |
4,595 |
11,443 |
16,346 |
||||||||||||
|
Total research and development expenses |
$ |
14,296 |
$ |
14,639 |
$ |
40,687 |
$ |
51,673 |
||||||||
The successful development of our product candidates is highly uncertain. At this time, we cannot reasonably estimate or know the nature, timing, and estimated costs of the efforts that will be necessary to complete the remainder of the development of our product candidates. We are also unable to predict when, if ever, material net cash inflows will commence from our product candidates, if approved. This is due to the numerous risks and uncertainties associated with developing our product candidates, including the uncertainty related to:
•
the timing and progress of preclinical and clinical development activities;
•
the number and scope of preclinical and clinical programs we decide to pursue;
•
our ability to raise additional funds necessary to complete clinical development of and, if applicable, commercialize our product candidates if and when approved;
•
our ability to maintain our current research and development programs and to establish new ones;
•
our ability to establish new licensing or collaboration arrangements;
•
the progress of the development efforts of parties with whom we may enter into collaboration arrangements;
•
the successful initiation and completion of clinical trials with safety, tolerability and efficacy profiles that are satisfactory to the FDA or any comparable foreign regulatory authority;
•
the receipt and related terms of regulatory approvals from applicable regulatory authorities;
•
the availability of raw materials and active pharmaceutical ingredient, or API, for use in production of our product candidates;
•
our ability to establish and operate a manufacturing facility, or secure manufacturing supply through relationships with third parties;
•
our ability to consistently manufacture our product candidates in quantities sufficient for use in clinical trials;
•
our ability to obtain and maintain intellectual property protection and regulatory exclusivity, both in the United States and internationally (including defending and enforcing our rights);
•
our ability to obtain and maintain third-party coverage and adequate reimbursement for our product candidates, if approved;
•
the acceptance of our product candidates, if approved, by patients, the medical community and third-party payors;
•
competition with other products; and
•
a continued acceptable safety profile of our products following receipt of any regulatory approvals.
A change in the outcome of any of these variables with respect to the development of any of our product candidates would significantly change the costs and timing associated with the development of that product candidate, and potentially other candidates.
Research and development activities account for a significant portion of our operating expenses. We expect our research and development expenses to increase in future periods as we continue to implement our business strategy, which includes advancing pociredir for the treatment of SCD, expanding our research and development efforts, including hiring additional personnel to support our research and development efforts, and seeking regulatory approvals for our product candidates that successfully complete clinical trials. In addition, product candidates in later stages of clinical development generally incur higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. As a result, we expect our research and development expenses to increase as our product candidates advance into later stages of clinical development. However, we do not believe that it is possible at this time to accurately project total program-specific expenses through approval and commercialization. There are numerous factors associated with obtaining regulatory approval and the successful commercialization of any of our product candidates, including future trial design and various regulatory requirements, many of which cannot be determined with accuracy at this time based on our stage of development.
General and Administrative Expenses
General and administrative expenses consist of personnel-related costs, including salaries, benefits and stock-based compensation expense, for our personnel in executive, finance and accounting, human resources, business operations and other administrative functions, legal fees related to patent, intellectual property and corporate matters, fees paid for accounting and tax services, consulting fees and facility-related costs not otherwise included in research and development expenses.
We expect that our general and administrative expenses will increase in the future to support continued research and development activities and planned commercialization activities, including establishing a sales, marketing and distribution infrastructure to commercialize any medicines for which we may obtain marketing approval. These increases will likely include increased costs related to the hiring of additional personnel, legal, audit, filing fees, and general compliance and consulting expenses, among other expenses.
Other Income, Net
Other income, net consists primarily of interest income related to our investments in cash equivalents and marketable securities.
Results of Operations
Comparison of the Three Months ended September 30, 2025 and 2024
The following summarizes our results of operations for the three months ended September 30, 2025 and 2024 along with the changes in those items in dollars:
|
Three Months Ended |
Change |
|||||||||||
|
(in thousands) |
2025 |
2024 |
$ |
|||||||||
|
Collaboration revenue |
- |
- |
- |
|||||||||
|
Operating expenses: |
||||||||||||
|
Research and development |
14,296 |
14,639 |
(343 |
) |
||||||||
|
General and administrative |
7,562 |
8,424 |
(862 |
) |
||||||||
|
Restructuring expenses |
- |
2,063 |
(2,063 |
) |
||||||||
|
Total operating expenses |
21,858 |
25,126 |
(3,268 |
) |
||||||||
|
Loss from operations |
(21,858 |
) |
(25,126 |
) |
3,268 |
|||||||
|
Other income, net |
2,263 |
3,430 |
(1,167 |
) |
||||||||
|
Net loss |
$ |
(19,595 |
) |
$ |
(21,696 |
) |
$ |
2,101 |
||||
Research and Development Expenses
The following table summarizes our research and development expenses for the three months ended September 30, 2025 and 2024:
|
Three Months Ended |
Change |
|||||||||||
|
(in thousands) |
2025 |
2024 |
$ |
|||||||||
|
External research and development |
$ |
8,378 |
$ |
8,171 |
$ |
207 |
||||||
|
Employee compensation |
4,017 |
4,594 |
(577 |
) |
||||||||
|
Laboratory supplies |
481 |
418 |
63 |
|||||||||
|
Facility costs |
1,131 |
1,174 |
(43 |
) |
||||||||
|
Other |
289 |
282 |
7 |
|||||||||
|
Total research and development expenses |
$ |
14,296 |
$ |
14,639 |
$ |
(343 |
) |
|||||
Research and development expense decreased by $0.3 million from $14.6 million for the three months ended September 30, 2024 to $14.3 million for the three months ended September 30, 2025. The decrease in research and development expense was primarily attributable to the following:
•
$0.6 million of decreased employee compensation costs due to decreased headcount, including a $0.5 million decrease in stock-based compensation expense;
•
partially offset by $0.2 million of increased external research and development costs, primarily due to increased development costs associated with the advancement of the Phase 1b PIONEER trial of pociredir, partially offset by decreased costs due to the suspension of the losmapimod program; and
•
increased laboratory supplies costs of $0.1 million.
General and Administrative Expenses
The following table summarizes our general and administrative expenses for the three months ended September 30, 2025 and 2024:
|
Three Months Ended |
Change |
|||||||||||
|
(in thousands) |
2025 |
2024 |
$ |
|||||||||
|
Employee compensation |
$ |
4,482 |
$ |
4,397 |
$ |
85 |
||||||
|
Professional services |
2,203 |
2,990 |
(787 |
) |
||||||||
|
Facility costs |
260 |
285 |
(25 |
) |
||||||||
|
Other |
617 |
752 |
(135 |
) |
||||||||
|
Total general and administrative expenses |
$ |
7,562 |
$ |
8,424 |
$ |
(862 |
) |
|||||
General and administrative expenses decreased by $0.8 million from $8.4 million for the three months ended September 30, 2024 to $7.6 million for the three months ended September 30, 2025. The decrease in general and administrative expenses was primarily attributable to the following:
•
$0.8 million of decreased professional services costs, primarily due to decreased commercial costs; and
•
$0.1 million of decreased other costs;
•
partially offset by $0.1 million of increased employee compensation costs.
Other Income, Net
Other income, net decreased by $1.1 million from $3.4 million for the three months ended September 30, 2024 to $2.3 million for the three months ended September 30, 2025. The decrease was primarily due to a decrease in our average cash, cash equivalents, and marketable securities balance.
Comparison of the Nine Months ended September 30, 2025 and 2024
The following summarizes our results of operations for the nine months ended September 30, 2025 and 2024 along with the changes in those items in dollars:
|
Nine Months Ended |
Change |
|||||||||||
|
(in thousands) |
2025 |
2024 |
$ |
|||||||||
|
Collaboration revenue |
- |
80,000 |
(80,000 |
) |
||||||||
|
Operating expenses: |
||||||||||||
|
Research and development |
40,687 |
51,673 |
(10,986 |
) |
||||||||
|
General and administrative |
21,389 |
28,732 |
(7,343 |
) |
||||||||
|
Restructuring expenses |
- |
2,063 |
(2,063 |
) |
||||||||
|
Total operating expenses |
62,076 |
82,468 |
(20,392 |
) |
||||||||
|
Loss from operations |
(62,076 |
) |
(2,468 |
) |
(59,608 |
) |
||||||
|
Other income, net |
7,530 |
9,311 |
(1,781 |
) |
||||||||
|
Net (loss) income |
$ |
(54,546 |
) |
$ |
6,843 |
$ |
(61,389 |
) |
||||
Collaboration Revenue
Collaboration revenue decreased by $80.0 million from the nine months ended September 30, 2024 to the nine months ended September 30, 2025. The decrease was attributable to the recognition of $80.0 million of revenue associated with the upfront license payment received during the second quarter of 2024 under the now terminated Sanofi collaboration agreement.
Research and Development Expenses
The following table summarizes our research and development expenses for the nine months ended September 30, 2025 and 2024:
|
Nine Months Ended |
Change |
|||||||||||
|
(in thousands) |
2025 |
2024 |
$ |
|||||||||
|
External research and development |
$ |
23,147 |
$ |
29,972 |
$ |
(6,825 |
) |
|||||
|
Employee compensation |
11,444 |
16,345 |
(4,901 |
) |
||||||||
|
Laboratory supplies |
1,812 |
1,236 |
576 |
|||||||||
|
Facility costs |
3,357 |
3,351 |
6 |
|||||||||
|
Other |
927 |
769 |
158 |
|||||||||
|
Total research and development expenses |
$ |
40,687 |
$ |
51,673 |
$ |
(10,986 |
) |
|||||
Research and development expense decreased by $11.0 million from $51.7 million for the nine months ended September 30, 2024 to $40.7 million for the nine months ended September 30, 2025. The decrease in research and development expense was primarily attributable to the following:
•
$6.8 million of decreased external research and development costs, primarily due to the suspension of the losmapimod program as well as $1.0 million of reimbursement from the global development cost sharing under our former collaboration with Sanofi for losmapimod, partially offset by increased development costs associated with the advancement of the Phase 1b PIONEER trial of pociredir; and
•
$4.9 million of decreased employee compensation costs due to decreased headcount, including a $1.9 million decrease in stock-based compensation expense;
•
partially offset by $0.6 million of increased laboratory supplies costs and $0.2 million of increased other costs.
General and Administrative Expenses
The following table summarizes our general and administrative expenses for the nine months ended September 30, 2025 and 2024:
|
Nine Months Ended |
Change |
|||||||||||
|
(in thousands) |
2025 |
2024 |
$ |
|||||||||
|
Employee compensation |
$ |
12,967 |
$ |
15,541 |
$ |
(2,574 |
) |
|||||
|
Professional services |
5,767 |
9,608 |
(3,841 |
) |
||||||||
|
Facility costs |
897 |
1,155 |
(258 |
) |
||||||||
|
Other |
1,758 |
2,428 |
(670 |
) |
||||||||
|
Total general and administrative expenses |
$ |
21,389 |
$ |
28,732 |
$ |
(7,343 |
) |
|||||
General and administrative expenses decreased by $7.3 million from $28.7 million for the nine months ended September 30, 2024 to $21.4 million for the nine months ended September 30, 2025. The decrease in general and administrative expenses was primarily attributable to the following:
•
$3.8 million of decreased professional services costs, primarily due to decreased commercial and legal costs;
•
$2.6 million of decreased employee compensation costs due to decreased headcount, including a $0.8 million decrease in stock-based compensation expense;
•
$0.3 million of decreased facility costs as a result of the expiration of our lease agreement for office space at 125 Sidney Street; and
•
$0.7 million of decreased other costs.
Other Income, Net
Other income, net decreased by $1.8 million from $9.3 million for the nine months ended September 30, 2024 to $7.5 million for the nine months ended September 30, 2025. The decrease was primarily attributable to the expiration of our sublease agreement for office space at 125 Sidney Street as well as a decrease in our average cash, cash equivalents, and marketable securities balance.
Liquidity and Capital Resources
Sources of Liquidity
We have incurred significant operating losses since our inception and expect to continue to incur significant operating losses for the foreseeable future and may never become profitable. We have not yet commercialized any of our product candidates, which are in various phases of preclinical and clinical development, and we do not expect to generate revenue from sales of any products for several years, if at all. As of September 30, 2025, we have funded our operations primarily with aggregate gross proceeds of $792.5 million from the sale of shares of our capital stock and from upfront payments received under our collaboration and license agreements. As of September 30, 2025, we had cash, cash equivalents, and marketable securities of $200.6 million.
In February 2024, we entered into a controlled equity offeringsm agreement with Cantor Fitzgerald & Co. and Stifel, Nicolaus & Company, Incorporated, as agents, with respect to an at-the-market offering program pursuant to which we may offer and sell, from
time to time in our sole discretion, shares of our common stock, par value $0.001 per share, having an aggregate offering price of up to $100.0 million through the agents. As of September 30, 2025, we have not issued or sold any shares of common stock under the at-the-market offering program.
Cash Flows
The following table provides information regarding our cash flows for the nine months ended September 30, 2025:
|
Nine Months Ended |
||||||||
|
(in thousands) |
2025 |
2024 |
||||||
|
Net cash (used in) provided by operating activities |
$ |
(43,267 |
) |
$ |
14,543 |
|||
|
Net cash provided by investing activities |
31,768 |
29,970 |
||||||
|
Net cash provided by financing activities |
365 |
2,663 |
||||||
|
Net (decrease) increase in cash, cash equivalents, and restricted cash |
$ |
(11,134 |
) |
$ |
47,176 |
|||
Net Cash (Used in) Provided by Operating Activities
Net cash used in operating activities was $43.3 million during the nine months ended September 30, 2025 compared to net cash provided by operating activities of $14.5 million during the nine months ended September 30, 2024. Net cash used in operating activities during the nine months ended September 30, 2025 was primarily due to our net loss of $54.5 million for the nine months ended September 30, 2025. Net cash provided by operating activities during the nine months ended September 30, 2024 primarily consisted of the $80.0 million upfront license payment during the second quarter of 2024 under our former Sanofi collaboration agreement.
Net Cash Provided by Investing Activities
Net cash provided by investing activities was $31.8 million during the nine months ended September 30, 2025 compared to net cash provided by investing activities of $30.0 million during the nine months ended September 30, 2024. The decrease in net cash provided by investing activities of $1.8 million was primarily due a decrease in net maturities of marketable securities during the nine months ended September 30, 2025, as compared to the nine months ended September 30, 2024.
Net Cash Provided by Financing Activities
Net cash provided by financing activities was $0.4 million during the nine months ended September 30, 2025 compared to net cash provided by financing activities of $2.7 million during the nine months ended September 30, 2024. Net cash provided by financing activities during the nine months ended September 30, 2025 primarily consisted of net proceeds of $0.2 million from the issuance of common stock under our benefit plans. Net cash provided by financing activities during the nine months ended September 30, 2024 primarily consisted of net proceeds of $2.4 million from the issuance of common stock under our benefit plans.
Funding Requirements
We expect our expenses to increase substantially in connection with our ongoing research and development activities, particularly as we continue the research and development of, initiate clinical trials of, and seek marketing approval for, our product candidates, some of which are in the discovery stage of development. In addition, we expect to incur additional costs to support the growth of our organization when appropriate. As a result, we expect to incur substantial operating losses and negative operating cash flows for the foreseeable future.
Based on our current operating plan, we believe that our existing cash, cash equivalents, and marketable securities as of September 30, 2025 will enable us to fund our operating expenses and capital expenditure requirements into 2028. However, we have based this estimate on assumptions that may prove to be wrong and we could exhaust our capital resources sooner than we expect.
Our funding requirements and timing and amount of our operating expenditures will depend largely on:
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the progress, costs and results of our clinical trials of pociredir;
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the scope, progress, costs and results of discovery research, preclinical development, laboratory testing and clinical trials for our current product candidates in additional indications or for any future product candidates that we may pursue, including under our license agreement with CAMP4;
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the number of and development requirements for other product candidates that we pursue;
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the costs, timing and outcome of regulatory review of our product candidates;
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our ability to enter into contract manufacturing arrangements for supply of API and manufacture of our product candidates and the terms of such arrangements;
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our ability to establish and maintain additional strategic collaborations, licensing or other arrangements and the financial terms of such arrangements;
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the payment or receipt of milestones, royalties and other collaboration-based revenues, if any;
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the costs and timing of future commercialization activities, including product manufacturing, sales, marketing and distribution, for any of our product candidates for which we may receive marketing approval and that we do not out-license to a third party;
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the amount and timing of revenue, if any, received from commercial sales of our product candidates for which we receive marketing approval;
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the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property and proprietary rights and defending any intellectual property-related claims; and
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the extent to which we acquire or in-license other products, product candidates, technologies or data referencing rights.
A change in the outcome of any of these or other variables with respect to the development of any of our product candidates could significantly change the costs and timing associated with the development of that product candidate. We will need to continue to rely on additional financing to achieve our business objectives.
In addition to the variables described above, if and when any of our product candidates successfully complete development, we will incur substantial additional costs associated with regulatory filings, marketing approval, post-marketing requirements, maintaining our intellectual property rights, and regulatory protection, in addition to other commercial costs. We cannot reasonably estimate these costs at this time.
Until such time, if ever, as we can generate substantial product revenue, we expect to finance our cash needs through a combination of equity offerings, debt financings, collaboration arrangements, strategic alliances and marketing, distribution or licensing arrangements. We currently have no credit facility or committed sources of capital. To the extent that we raise additional capital through the future sale of equity securities, the ownership interests of our stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our existing common stockholders. If we raise additional funds through the issuance of debt securities, these securities could contain covenants that would restrict our operations. We may require additional capital beyond our currently anticipated amounts, and additional capital may not be available on reasonable terms, or at all. If we raise additional funds through collaboration arrangements, strategic alliances or marketing, distribution or licensing arrangements in the future, we may have to relinquish valuable rights to our technologies, future revenue streams or product candidates, or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
Critical Accounting Policies and Estimates
Our management's discussion and analysis of our financial condition and results of operations are based on our consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States. The preparation of these consolidated financial statements requires us to make judgments and estimates that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated financial statements, and the reported amounts of expenses during the reporting periods. Our estimates are based on our historical experience, known trends and events, and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities and amount of expense recognized that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. We evaluate our estimates and assumptions on an ongoing basis. The effects of material revisions in estimates, if any, will be reflected in the consolidated financial statements prospectively from the date of change in estimates. During the three months ended September 30, 2025, there were no material changes to our critical accounting policies from those described in our Annual Report on Form 10-K filed with the SEC on February 25, 2025.
Recently Issued Accounting Pronouncements
A description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 2 to our consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q.
Fulcrum Therapeutics Inc. published this content on October 29, 2025, and is solely responsible for the information contained herein. Distributed via Edgar on October 29, 2025 at 11:11 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]