Vor Biopharma Inc.
For the period ended Mar 31, 2026. Filed May 13, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2026 · Filed May 13, 2026
VOR$19.88+6.5%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-09-30; filed 2025-11-13.
0001193125-25-280104
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-03-31; filed 2026-05-13.
0001193125-26-220689
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 134 previous paragraphs and 111 current paragraphs.
73 unchanged; 32 reworded; 6 added; 28 removed; 1 previous and 0 current paragraphs rearranged.
Tables are not compared: 5 previous and 3 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (6)
Current report
We are also evaluating telitacicept in a global Phase 3 clinical trial for the treatment of SjD. The first patient in this trial was dosed in March 2026, and we expect to recruit a total of approximately 250 adults with SjD in the United States, Europe, South America, and Asia. The trial is a randomized, double-blind, placebo-controlled trial.
Current report
General and administrative expenses were $17.6 million for the three months ended March 31, 2026, compared to $6.6 million for the three months ended March 31, 2025. The increase of $11.0 million was primarily due to a $7.4 million increase in stock-based compensation expense, a $1.4 million increase in personnel-related expenses, a $1.2 million increase in commercial-related expenses, and a $1.0 million increase in professional fees. The increase in stock-based compensation was primarily driven by grants to the new executives hired after the quarter ended March 31, 2025, as well as an appreciation in our stock price and incremental expense recognized from award modifications which took place at the end of the year ended December 31, 2025. The increase in personnel-related expenses was due primarily to new general administrative employees hired during 2025, including new executives.
Current report
At-the-Market Sales Agreements
Current report
On March 26, 2026, we entered into a purchase agreement with institutional investors pursuant to which we agreed to issue and sell an aggregate of 5,338,078 shares of common stock, at a price per share of $14.05, for net proceeds of $74.9 million after deducting offering expenses payable by us. The private placement closed on March 30, 2026.
Current report
expand our office facility or establish dedicated laboratory and manufacturing facilities; and
Current report
Net cash provided by financing activities was $74.9 million for the three months ended March 31, 2026, which primarily consisted of $75.0 million in gross proceeds from the issuance of common stock in the March 2026 private placement, partially offset by $0.1 million of payments made in the period for issuance costs relating to the December 2025 private placement. Net cash used in financing activities was $0.6 million for the three months ended March 31, 2025, which primarily consisted of $0.6 million of payments for issuance costs relating to the December 2024 private placement.
Removed paragraphs (28)
Previous report
Telitacicept is a novel fusion protein for treating autoimmune diseases. It is constructed with the extracellular domain of the human transmembrane activator and calcium modulator and cyclophilin ligand interactor (“TACI”) receptor and the fragment crystallizable (“Fc”) domain of human immunoglobulin G (“IgG”). Telitacicept targets and acts on two cell signaling molecules critical for B lymphocyte development: B cell lymphocyte stimulator (“BLyS”), also known as B cell activating factor (“BAFF”), and a proliferation inducing ligand (“APRIL”), which allows it to effectively reduce B cell mediated autoimmune responses that are implicated in several autoimmune diseases.
Previous report
Patients on telitacicept throughout the trial achieved a -7.5 mean MG-ADL change from baseline, while placebo crossover patients achieved -6.3; 96.2% of continuous patients and 90.2% of crossover patients reached ≥3-point improvement.
Previous report
Patients on telitacicept throughout the trial achieved a -9.8 mean QMG change from baseline, while placebo crossover patients achieved -9.3; 94.2% of continuous patients and 90.2% of crossover patients reached ≥5-point improvement.
Previous report
Telitacicept demonstrated a favorable safety profile comparable to placebo and consistent with prior clinical trials and post-marketing data across other autoimmune indications, including SLE, RA, SD and IgAN. No new safety signals were observed. Most adverse events were mild to moderate in severity.
Previous report
No injection site reactions were reported during the open-label extension period in patients previously on telitacicept. Injection site reactions in placebo crossover patients were mild, self-resolving and did not lead to discontinuation.
Previous report
Our broader development plan includes exploring development of telitacicept in additional autoantibody-driven diseases where BAFF / APRIL signaling is a validated target, supported by prior clinical experience and mechanistic rationale. This includes Sjögren’s disease, one of the most common systemic autoimmune diseases globally. There are no approved disease-modifying
Previous report
Mean change in ESSDAI score from baseline: At week 24, -4.4 (160mg), -3.0 (80mg), and -0.6 (placebo); at week 48, -4.6 (160mg), -3.2 (80mg), and -0.4 (placebo). These data demonstrate durable, dose-dependent improvement in systemic disease activity.
Previous report
Mean change in ESSPRI score from baseline: At week 24, -1.88 (160mg), -1.31 (80mg), and -0.36 (placebo); at week 48, -2.56 (160mg), -1.74 (80mg), and -0.41 (placebo). These data showed sustained symptomatic benefit in dryness, fatigue, and pain.
Previous report
≥3-point ESSDAI score improvement: At week 24, 71.8% (160mg), 47.1% (80mg), and 19.3% (placebo); at week 48, 73.0% (160 mg), 49.1% (80mg), and 16.5% (placebo).
Previous report
Participants with ESSDAI score <5 (low disease activity): At week 24, 49.6% (160mg), 28.8% (80mg), and 10.9% (placebo); at week 48, 55.0% (160mg), 32.7% (80mg), and 12.2% (placebo).
Previous report
Participants with ≥1-point or ≥15% ESSPRI score reduction: At week 24, 86.2% (160mg), 63.0% (80mg), and 32.2% (placebo); at week 48, 89.1% (160mg), 75.4% (80mg), and 33.3% (placebo).
Previous report
Change from baseline in MFI-20 total (fatigue): At weeks 24 and 48, telitacicept 160mg and telitacicept 80mg each produced a statistically significant reduction in fatigue versus 80mg and placebo, with improvements sustained through the open-label extension period.
Previous report
Telitacicept demonstrated a favorable safety profile comparable to placebo and consistent with prior studies across other autoimmune indications, including systemic lupus erythematosus, rheumatoid arthritis, myasthenia gravis, and IgA nephropathy. No new safety signals were observed. Most adverse events were mild to moderate in severity.
Previous report
Restructuring Plan
Previous report
On May 5, 2025, the Company’s board of directors approved the wind down of the Company’s existing clinical and manufacturing operations focused on previous product candidates (the “Restructuring Plan”). The Company publicly announced this plan on May 8, 2025. In conjunction with the Restructuring Plan, the Company announced a reduction of its workforce by 154 full-time employees, or approximately 99% of the Company’s then-current employee base.
Previous report
During the nine months ended September 30, 2025, we incurred restructuring costs of $29.7 million which is comprised of severance payments, stock-based compensation modifications, loss on disposal of long-lived assets and accelerated depreciation and amortization on long-lived assets and right-of-use assets.
Previous report
Other Income
Previous report
Other income represents the proceeds received from the sale of certain intellectual property related to the Company’s previous product candidates trem-cel, VCAR33 and VADC45.
Previous report
Research and development expenses were $302.3 million for the nine months ended September 30, 2025, compared to $68.0 million for the nine months ended September 30, 2024. The increase of $234.4 million was primarily due to the upfront consideration transferred for the license agreement with RemeGen for telitacicept (the “Telitacicept License Agreement”) of $222.6 million, $13.1 million in research and development activities on telitacicept-MG as the Company began research and development activities for the new program, $3.3 million in loss on disposal of long-lived assets, and $11.2 million in accelerated depreciation and amortization due to the abandonment of long-lived assets (including the right-of-use asset) and the early termination penalty for the lease, partially offset by lower stock-based compensation and personnel costs as the Company had lower headcount following the Restructuring Plan.
Previous report
General and administrative expenses were $14.0 million for the three months ended September 30, 2025, compared to $6.7 million for the three months ended September 30, 2024. The increase of $7.3 million was primarily due to an increase in stock-based compensation expense.
Previous report
General and administrative expenses were $33.3 million for the nine months ended September 30, 2025, compared to $21.9 million for the nine months ended September 30, 2024. The increase of $11.4 million was primarily due to an increase in stock-based compensation expense, an increase in personnel costs from the termination payments owed to employees subject to the Restructuring Plan, and an increase in facilities and other expenses from accelerated depreciation and loss on disposals of long-lived assets.
Previous report
At-the-Market Sales Agreement
Previous report
During October 2025, we sold an additional 1,370,111 shares of our common stock under the Stifel ATM Facility at a weighted-average price per share of $36.73 for aggregate net proceeds of $49.8 million, after deducting commissions. Following these sales, $48.9 million remained available to be sold under the Stifel ATM Facility.
Previous report
Underwritten Public Offering
Previous report
On November 12, 2025, we issued and sold 10,000,000 shares of common stock in an underwritten public offering at a price to the public of $10.00 per share, for net proceeds of approximately $93.7 million, after deducting the underwriting discounts and commissions and estimated offering expenses. In addition, on November 12, 2025, the underwriters exercised in full their option to purchase 1,500,000 additional shares of common stock at the public offering price, less the underwriting discounts and commissions. The closing of the purchase of the additional shares is expected to occur on November 14, 2025, subject to satisfaction of customary closing conditions, for additional expected net proceeds of $14.1 million, after deducting the underwriting discounts and commissions (collectively, the “November 2025 Offering”).
Previous report
acquire and expand office facilities; and
Previous report
The $44.3 million increase in net cash used in operating activities for the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024 was primarily due to the $45.0 million up-front license payment due under the Telitacicept License Agreement.
Previous report
Net cash provided by financing activities was $196.0 million for the nine months ended September 30, 2025, which primarily consisted of $175.0 million in proceeds from the issuance of pre-funded warrants, $20.3 million in proceeds from the issuance of common stock under the Stifel ATM Facility, and $2.1 million in proceeds from the exercise of stock options and issuance of shares under the ESPP, partially offset by $1.2 million of issuance costs related to the December 2024 private placement and June 2025 private placement. Net cash provided by financing activities was $0.1 million for the nine months ended September 30, 2024, which consisted of proceeds from the issuance of common stock under the Stifel ATM Facility of $0.3 million and proceeds from exercise of stock options and issuance of shares under the ESPP of $0.1 million, offset by $0.3 million of taxes paid related to net share settlement of equity awards.
Reworded paragraphs (32)
Previous wording
Vor Bio is a clinical-stage biopharmaceutical company focused on developing a novel therapy in the treatment of autoimmune diseases. In June 2025, we in-licensed telitacicept from RemeGen Co., Ltd. (“RemeGen”). Telitacicept is approved in China for the treatment of generalized myasthenia gravis (“gMG”), systemic lupus erythematosus (“SLE”) and rheumatoid arthritis (“RA”). RemeGen has also filed Biologics License Applications (“BLAs”) in China for the treatment of Sjögren’s disease (“SD”) and IgA nephropathy (“IgAN”).
Current wording
Vor Bio is a clinical-stage biopharmaceutical company focused on developing a novel therapy in the treatment of autoimmune diseases. In June 2025, we in-licensed telitacicept from RemeGen Co., Ltd. (“RemeGen”).
Previous wording
Pursuant to our license agreement with RemeGen, we were granted an exclusive license to develop and commercialize telitacicept outside of the Greater China region, which includes mainland China, Hong Kong, Macau and Taiwan. RemeGen retains development and commercialization rights in Greater China.
Current wording
Pursuant to our license agreement with RemeGen, we were granted an exclusive license to develop and commercialize telitacicept outside of the Greater China region, which includes mainland China, Hong Kong, Macau and Taiwan. RemeGen retains development and commercialization rights in Greater China. Telitacicept is approved in China for the treatment of generalized myasthenia gravis (“gMG”), systemic lupus erythematosus (“SLE”) and rheumatoid arthritis (“RA”), and has two Biologics License Applications (“BLAs”) filed and pending in China for the treatment of Sjögren’s disease (“SjD”) and IgA nephropathy (“IgAN”).
Previous wording
Telitacicept is currently being evaluated in a global Phase 3 clinical trial, for which we are assuming responsibility from RemeGen in connection with the license agreement, for the treatment of gMG. The trial is currently recruiting patients in North America, Europe, Latin America, and Asia to support potential approval in the United States, Europe, Japan and other countries. In July 2024, the clinical trial enrolled a patient in the United States, the first in the global clinical trial.
Current wording
Telitacicept is currently being evaluated in a global Phase 3 clinical trial, for which we have assumed responsibility from RemeGen in connection with the license agreement, for the treatment of gMG. The trial is currently recruiting patients in North America, Europe, Latin America, and Asia to support potential approval in the United States, Europe, Japan and other countries. In July 2024, the clinical trial enrolled a patient in the United States, the first in the global clinical trial. Topline data from the trial is anticipated in the first half of 2027.
Previous wording
The data from the open-label treatment period (Part B) of the Phase 3 trial were presented at the American Association of Neuromuscular & Electrodiagnostic Medicine (“AANEM”) meeting in October 2025. The data at week 48 demonstrated:
Current wording
Telitacicept was evaluated by RemeGen in a Phase 3 clinical trial in patients with gMG in China. Most recently, the 48-week data from Part B of the Phase 3 trial were presented at the American Association of Neuromuscular & Electrodiagnostic Medicine (“AANEM”) Annual Meeting in October 2025.
Previous wording
The data from the RemeGen-sponsored Phase 3 trial conducted in China evaluating telitacicept in SD were presented at the American College of Rheumatology (“ACR”) Convergence meeting in October 2025. The 48-week results demonstrated:
Current wording
Telitacicept was evaluated by RemeGen in a Phase 3 clinical trial in patients with active SjD in China. Most recently, the 48-week data including Stage A and B from the Phase 3 trial were presented at the American College of Rheumatology (“ACR”) Annual Meeting in October 2025.
Previous wording
We have incurred significant operating losses since inception, including net losses of $812.7 million and $2,418.8 million for the three and nine months ended September 30, 2025, respectively and $116.9 million for the year ended December 31, 2024. As of September 30, 2025, we had an accumulated deficit of $2,875.8 million.
Current wording
We have incurred significant operating losses since inception, including net losses of $219.6 million and $32.5 million for the three months ended March 31, 2026 and 2025, respectively. As of March 31, 2026, we had an accumulated deficit of $1,372.6 million.
Previous wording
As of September 30, 2025, we had cash, cash equivalents and marketable securities of $170.5 million. Based on our current operating plan and considering the net proceeds of $49.8 million from the sale of shares of common stock under our at-the-market sales facility during October 2025 and the approximately $107.8 million in net proceeds and expected net proceeds from the November 2025 Offering (as defined below), we expect that our cash, cash equivalents and marketable securities will enable us to fund our operating expenses and capital expenditure requirements into the second quarter of 2027.
Current wording
As of March 31, 2026, we had cash, cash equivalents and marketable securities of $491.5 million. Based on our current operating plan, we expect that our cash, cash equivalents and marketable securities will enable us to fund our operating expenses and capital expenditure requirements into early 2029.
Previous wording
Our management’s discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements, which have been prepared in accordance with United States generally accepted accounting principles. The preparation of our condensed consolidated financial statements requires us to make judgments and estimates that affect the reported amounts of assets, liabilities, costs, and expenses, and the disclosure of contingent assets and liabilities in our condensed consolidated financial statements. We base our estimates on historical experience, known trends and events, and various other factors that we believe to be reasonable under the circumstances. Actual results may differ from these estimates under different assumptions or conditions. On an ongoing basis, we evaluate our judgments and estimates in light of changes in circumstances, facts, and experience. The effects of material revisions in estimates, if any, will be reflected in the condensed consolidated financial statements prospectively from the date of change in estimates. During the nine months ended September 30, 2025, in connection with our decision to wind down clinical and manufacturing operations related to previous product candidates, we have revised certain estimates related to accrued research and development. There have been no other material changes to our critical accounting estimates from those described in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our 2024 Annual Report.
Current wording
Our management’s discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements, which have been prepared in accordance with United States generally accepted accounting principles. The preparation of our condensed consolidated financial statements requires us to make judgments and estimates that affect the reported amounts of assets, liabilities, costs, and expenses, and the disclosure of contingent assets and liabilities in our condensed consolidated financial statements. We base our estimates on historical experience, known trends and events, and various other factors that we believe to be reasonable under the circumstances. Actual results may differ from these estimates under different assumptions or conditions. On an ongoing basis, we evaluate our judgments and estimates in light of changes in circumstances, facts, and experience. The effects of material revisions in estimates, if any, will be reflected in the condensed consolidated financial statements prospectively from the date of change in estimates. There have been no changes to our critical accounting estimates from those described in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our 2025 Annual Report.
Previous wording
facilities, depreciation and other allocated expenses, which include direct and allocated expenses for rent, insurance, and other internal operating costs, and internal manufacturing expenses.
Current wording
facilities, depreciation and other allocated expenses, which include direct and allocated expenses for rent, insurance, and other internal operating costs.
Previous wording
launching commercial sales of our product candidate or any future product candidates, if approved, whether alone or in collaboration with others; and
Current wording
launching commercial sales of our product candidates, if approved, whether alone or in collaboration with others; and
Previous wording
maintaining a continued acceptable safety profile of our product candidate or any future product candidates following approval.
Current wording
maintaining a continued acceptable safety profile of the product candidates following approval.
Previous wording
Any changes 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 candidate or any future product candidate.
Current wording
Any changes 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.
Previous wording
We expect that our general and administrative expenses will increase as our business expands and we hire additional personnel to support the development of telitacicept.
Current wording
We expect that our general and administrative expenses will increase as our business expands and we hire additional personnel to support our continued development of our clinical programs. We also anticipate continued increased expenses associated with being a public company, including costs for legal, audit, accounting, investor and public relations, regulatory and tax-related services related to compliance with the rules and regulations of the SEC, Nasdaq listing standards and director and officer insurance premiums.
Previous wording
Interest income consists of interest income earned on our cash, cash equivalents, restricted cash equivalents and marketable securities held in financial institutions.
Current wording
Interest income consists of interest income earned on our cash, cash equivalents and marketable securities held in financial institutions.
Previous wording
Comparison of Three and Nine Months Ended September 30, 2025 and 2024
Current wording
Comparison of Three Months Ended March 31, 2026 and 2025
Previous wording
Research and development expenses were $14.1 million for the three months ended September 30, 2025, compared to $21.8 million for the three months ended September 30, 2024. The decrease of $7.7 million was primarily due to lower stock-based compensation and personnel costs as the Company had lower headcount following the implementation of the Restructuring Plan and reduced spend on its previous programs, trem-cel and VCAR33, partially offset by the $13.1 million increase in spend on telitacicept - gMG, as the Company began research and development activities for the new program.
Current wording
Research and development expenses were $17.6 million for the three months ended March 31, 2026, compared to $26.7 million for the three months ended March 31, 2025. The decrease of $9.1 million was primarily due to $9.7 million in reduced spend on our previous programs, trem-cel and VCAR33, a $5.6 million decrease in personnel costs as we had lower headcount compared to the prior year, a $3.5 million decrease in manufacturing and facilities costs as our manufacturing activities and leased properties have both been reduced compared to the prior year, a $2.2 million decrease in other research and development costs, and a $0.4 million decrease in stock-based compensation. These decreases were partially offset by a $12.3 million increase in spend for our new programs, telitacicept - gMG and telitacicept - SjD.
Previous wording
Other income (expense) decreased by $785.5 million during the three months ended September 30, 2025, compared to the three months ended September 30, 2024. Other income (expense) decreased by $2,086.8 million during the nine months ended September 30, 2025, compared to the nine months ended September 30, 2024. The decrease in other income (expense) in both periods was primarily due to the issuance of liability-classified warrants and the subsequent changes in fair value of the warrant liabilities resulting from changes in the quoted price of the Company’s common stock underlying the warrants, offset in part by the proceeds from the sale of intellectual property related to the Company’s previous programs.
Current wording
Other income (expense) decreased by $185.2 million during the three months ended March 31, 2026, compared to the three months ended March 31, 2025. The decrease in other income (expense) was primarily due to the change in fair value of the warrant liabilities resulting from changes in the quoted price of the Company’s common stock underlying the warrants.
Previous wording
Since our inception, we have not recognized any revenue and have incurred operating losses and negative cash flows from our operations. We have not yet commercialized any product and we do not expect to generate revenue from sales of any products for several years, if at all. We have funded our operations primarily through the sale of equity securities and have received aggregate net proceeds from financing transactions of approximately $711.7 million as of September 30, 2025.
Current wording
Since our inception, we have not recognized any revenue and have incurred operating losses and negative cash flows from our operations. We have not yet commercialized any product and we do not expect to generate revenue from sales of any products for several years, if at all. We have funded our operations primarily through the sale of equity securities and have received aggregate net proceeds from these transactions of approximately $1,094.1 million as of March 31, 2026.
Previous wording
On March 20, 2025, we filed a universal shelf registration statement (the “Shelf Registration Statement”), to provide for aggregate offerings of up to $350.0 million of common stock, preferred stock, debt securities, warrants or any combination thereof. As of September 30, 2025, $329.5 million remains available under this Shelf Registration Statement, including $99.2 million reserved for at-the-market offerings discussed below. Following the additional at-the-market sales during October 2025 and the November 2025 Offering, assuming the closing of the purchase of the 1,500,000 additional shares by the underwriters occurs, $158.9 million remains available under this Shelf Registration Statement, with $48.9 million reserved for at-the-market offerings.
Current wording
In order to fund our future operations, including our ongoing and planned clinical trials, we filed a universal shelf registration statement, which was declared effective on March 31, 2025, to provide for aggregate offerings of up to $350.0 million of common stock, preferred stock, debt securities, warrants or any combination thereof. As of March 31, 2026, $164.2 million remains available under this Shelf Registration Statement, including $48.9 million reserved for at-the-market offerings discussed below.
Previous wording
In December 2022, we entered into a Sales Agreement with Stifel, Nicolaus & Company, Incorporated (“Stifel”) as the agent (the "Stifel ATM Facility"). Pursuant to the Stifel ATM Facility, we may offer and sell shares of common stock with an aggregate value of up to $125.0 million. We will pay Stifel a commission of up to 3.0% of the gross proceeds of any common stock sold through Stifel. We sold 540,750 shares of our common stock under the Stifel ATM Facility during the nine months ended September 30, 2025 at a weighted-average price per share of $37.89 for aggregate net proceeds of $20.3 million, after deducting commissions. As of September 30, 2025, $99.2 million remained available to be sold under the Stifel ATM Facility.
Current wording
In December 2022, we entered into a Sales Agreement with Stifel, Nicolaus & Company, Incorporated (“Stifel”) as the agent (the "Stifel ATM Facility"). Pursuant to the Stifel ATM Facility, we may offer and sell shares of common stock with an aggregate value of up to $125.0 million. We pay Stifel a commission of up to 3.0% of the gross proceeds of any common stock sold through Stifel. We did not sell any shares of our common stock under the Stifel ATM Facility during the three months ended March 31, 2026. As of March 31, 2026, $48.9 million remained available to be sold under the Stifel ATM Facility.
Previous wording
As of September 30, 2025, we had cash, cash equivalents and marketable securities of $170.5 million. We will need to raise additional capital in the future to fund our planned future operations. However, we cannot guarantee that we will be able to obtain sufficient additional funding or that if we do obtain additional funding, that such funding will be obtainable on terms satisfactory to us. In the event that we are unable to obtain sufficient additional funding, there can be no assurance that we will be able to continue as a going concern.
Current wording
As of March 31, 2026, we had cash, cash equivalents and marketable securities of $491.5 million. We will need to raise additional capital in the future to fund our planned future operations.
Previous wording
Based on our current operating plan and considering the additional at-the-market sales during October 2025 and the net proceeds and expected net proceeds from the November 2025 Offering, we expect that our existing cash, cash equivalents and marketable securities will enable us to fund our operating expenses and capital expenditure requirements into the second quarter of 2027. We have based this estimate on assumptions that may prove to be wrong and we could exhaust our capital resources sooner than we expect.
Current wording
We expect that our existing cash, cash equivalents and marketable securities will enable us to fund our operating expenses and capital expenditure requirements into early 2029. We have based this estimate on assumptions that may prove to be wrong and we could exhaust our capital resources sooner than we expect.
Previous wording
continue research and clinical development of our product candidate and any future product candidate, including in particular the expenses associated with our clinical trials;
Current wording
continue clinical development of our product candidate and any future product candidates, including in particular the expenses associated with our clinical trials;
Previous wording
incur both internal and third party manufacturing costs to support our clinical trials of our product candidate and any future product candidate and, if approved, their commercialization;
Current wording
incur third party manufacturing costs to support our clinical trials of our product candidate and any future product candidates and, if approved, their commercialization;
Previous wording
In addition, we expect to continue to incur costs associated with operating as a public company, including significant legal, audit, accounting, investor and public relations, regulatory, tax-related, director and officer insurance premiums, investor relations and other expenses. Developing pharmaceutical products, including conducting clinical trials, is a time-consuming, expensive and uncertain process that takes years to complete, and we may never generate the necessary data or results required to obtain marketing approval for any product candidates or generate revenue from the sale of any product candidate for which we may obtain marketing approval. In addition, our product candidates, if approved, may not achieve commercial success. Our commercial revenues, if any, will be derived from sales of products that we do not expect to be commercially available for at least several years, if ever.
Current wording
In addition, we expect to continue to incur additional costs associated with operating as a public company, including significant legal, audit, accounting, investor and public relations, regulatory, tax-related, director and officer insurance premiums, investor relations and other expenses. Developing pharmaceutical products, including conducting clinical trials, is a time-consuming, expensive and uncertain process that takes years to complete, and we may never generate the necessary data or results required to obtain marketing approval for any product candidates or generate revenue from the sale of any product candidate for which we may obtain marketing approval. In addition, our product candidates, if approved, may not achieve commercial success. Our commercial revenues, if any, will be derived from sales of products that we do not expect to be commercially available for at least several years, if ever.
Previous wording
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 the public or private sale of our equity, government or private party grants, debt financings or other capital sources, including potential collaborations with other companies or other strategic transactions. To the extent that we raise additional capital through the sale of our equity or convertible debt securities, including through the use of the Stifel ATM Facility, the ownership interest of our shareholders may be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our stockholders. Debt financing and equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we are unable to obtain additional funding, we could be forced to delay, reduce or eliminate some or all of our research and development programs, product portfolio expansion or any commercialization efforts, which could adversely affect our business prospects, or we may be unable to continue operations. If we raise funds through strategic collaborations or other similar arrangements with third parties, we may have to relinquish valuable rights to our platform technology, future revenue streams, research programs or product candidates or may have to grant licenses on terms that may not be favorable to us and/or may reduce the value of our common stock. Our ability to raise additional funds may be adversely impacted by worsening global economic conditions and disruptions to and volatility in the credit and financial markets in the United States and worldwide resulting from geopolitical tensions and adverse macroeconomic conditions or otherwise. Because of the numerous risks and uncertainties associated with product development, we cannot predict the timing or amount of increased expenses, and there is no assurance that we will ever be profitable or generate positive cash flow from operating activities.
Current wording
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 the public or private sale of our equity, government or private party grants, debt financings or other capital sources, including potential collaborations with other companies or other strategic transactions. To the extent that we raise additional capital through the sale of our equity or convertible debt securities, including through the use of the Stifel ATM Facility, the ownership interest of our shareholders will be or could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our stockholders. Debt financing and equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we are unable to obtain additional funding, we could be forced to delay, reduce or eliminate some or all of our research and development programs, product portfolio expansion or any commercialization efforts, which could adversely affect our business prospects, or we may be unable to continue operations. If we raise funds through strategic collaborations or other similar arrangements with third parties, we may have to relinquish valuable rights to our intellectual property, future revenue streams, research programs or product candidates or may have to grant licenses on terms that may not be favorable to us and/or may reduce the value of our common stock. Our ability to raise additional funds may be adversely impacted by worsening global economic conditions and disruptions to and volatility in the credit and financial markets in the United States and worldwide resulting from worsening geopolitical tensions and adverse macroeconomic conditions or otherwise. Because of the numerous risks and uncertainties associated with product development, we cannot predict the timing or amount of increased expenses, and there is no assurance that we will ever be profitable or generate positive cash flow from operating activities.
Previous wording
We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements that have or are reasonably likely to have a material current or future effect on our financial condition, revenues or expenses, results of operations, liquidity, cash requirements or capital resources.
Current wording
We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements that have, or are reasonably likely to have, a material current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, cash requirements or capital resources.
Previous wording
Net cash used in operating activities was $119.9 million for the nine months ended September 30, 2025, reflecting a net loss of $2,418.8 million, offset by changes in operating assets and liabilities of $7.0 million and non-cash charges of $2,291.9 million. The non-cash charges primarily consisted of the change in fair value of warrant liabilities of $2,090.4 million and the issuance of pre-funded warrants in connection with the acquisition of in-process research and development of $177.4 million.
Current wording
Net cash used in operating activities was $38.2 million for the three months ended March 31, 2026, reflecting a net loss of $219.6 million, offset by changes in operating assets and liabilities of $15.5 million and non-cash charges of $196.9 million. The non-cash charges primarily consisted of the change in fair value of warrant liabilities of $188.4 million and $8.9 million of stock-based compensation expense. The change in operating assets and liabilities was primarily due to a decrease of $9.1 million of accounts payable and accrued expenses as much of the accrued expenses relating to the prior period were paid in the three months ended March 31, 2026. The change was also due to the increase of $6.4 million of prepaid expense and other current assets, primarily driven by the increase of prepayments made for our clinical programs and an increase in accrued interest on marketable securities.
Previous wording
Net cash used in operating activities was $75.6 million for the nine months ended September 30, 2024, reflecting a net loss of $86.2 million and net cash used of $2.8 million for operating assets and liabilities, which were offset by non-cash charges of $13.4 million. The non-cash charges primarily consisted of stock-based compensation expense of $8.1 million, non-cash lease expense of $3.8 million and depreciation expense of $2.7 million, offset by $1.1 million of non-cash interest earned on marketable securities.
Current wording
Net cash used in operating activities was $31.1 million for the three months ended March 31, 2025, reflecting a net loss of $32.5 million and net cash used of $2.6 million for operating assets and liabilities, which were partially offset by non-cash charges of $4.1 million. The non-cash charges primarily consisted of stock-based compensation expense of $1.9 million, non-cash lease expense of $1.3 million and depreciation expense of $0.8 million.
Previous wording
Net cash provided by investing activities was $0.2 million for the nine months ended September 30, 2025, which consisted of proceeds from the sales of property and equipment of $0.8 million, partially offset by $0.6 million in purchases of property and equipment. Net cash provided by investing activities was $96.9 million for the nine months ended September 30, 2024, which consisted of proceeds of $107.0 million from the maturity of marketable securities, partially offset by purchases of $9.9 million of marketable securities and $0.2 million of property and equipment.
Current wording
Net cash used in investing activities was $263.2 million for the three months ended March 31, 2026, which consisted of the purchases of $276.5 million of marketable securities and $0.1 million of equipment, partially offset by $13.3 million of proceeds from the maturities of marketable securities. Net cash used in investing activities was $0.2 million for the three months ended March 31, 2025, which primarily consisted of purchases of $0.2 million of property and equipment.
Previous wording
As noted in Note 9 to the unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q, we amended our lease for corporate office and laboratory real estate space to terminate on August 4, 2025. On June 30, 2025, we abandoned such space and have no remaining contractual payments related to the leased space. As further noted in Note 9 to the unaudited condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q, on August 12, 2025, we entered into a non-cancellable lease relating to corporate office space, with a term expiring in August 2031.
Current wording
Contractual obligations relate to future minimum lease payments for an existing non-cancellable lease relating to corporate office space, with a term expiring in August 2031.
Previous wording
Other than the changes discussed above, during the nine months ended September 30, 2025, there were no additional significant changes in contractual obligations and commitments from that described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Contractual Obligations and Other Commitments” in our 2024 Annual Report.
Current wording
There were no significant changes in contractual obligations and other commitments from that described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Contractual Obligations and Other Commitments” in our 2025 Annual Report.
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Previous report — wording carried elsewhere
systemic therapies for the treatment of Sjögren’s disease.