Q32 Bio Inc.
For the period ended Sep 30, 2026. Filed Nov 4, 2026.
View on SEC.govAbout this filing
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.
Sep 30, 2026 · Filed Nov 4, 2026
QTTB$9.25+4.5%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-06-30; filed 2026-08-05.
0001193125-26-333831
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-04.
0001193125-26-446206
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 159 previous paragraphs and 160 current paragraphs.
119 unchanged; 32 reworded; 7 added; 7 removed; 1 previous and 2 current paragraphs rearranged.
Tables are not compared: 6 previous and 6 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 (7)
Current report
In September 2026, we presented initial findings from the 16-week off-drug follow-up period from Part B of the SIGNAL-AA program:
Current report
In total, 18 patients entered the 16-week off-drug period. At the 16-week off-drug time point, 44% of patients achieved a SALT-20 response, 61% achieved SALT30 response, and 50% achieved SALT50 response.
Current report
Of the patients who entered the off-drug follow-up period, 12 patients had demonstrated hair growth by the end of the treatment period at Week 36. Maintenance of response (with maintenance defined as a less than 20-point SALT score worsening from the last on-treatment value) was observed in 100% of these patients and deepening of response was observed in 42% of these patients. Mean SALT score in these patients remained stable through 16-weeks off-drug.
Current report
In the 16-week off-drug follow-up period, one patient who achieved a SALT-10 at Week 36 achieved complete hair growth (SALT = 0) and two additional patients who achieved a SALT-20 at Week 36 had a deepening of response and achieved a SALT-10.
Current report
One latent responder during the 36-week treatment period converted to a response, achieving a SALT-20, at the end of the 16-week off-drug period.
Current report
Other income, net was $1.7 million for the three months ended September 30, 2026, compared to $0.2 million for the three months ended September 30, 2025. The increase of $1.5 million was primarily due to higher average cash balance resulting in higher interest income for the three months ended September 30, 2026. Also, other income, net for the three months ended September 30, 2025 includes interest expense related to our venture debt that was repaid in June 2026.
Current report
Comparison of the nine months ended September 30, 2026 and 2025
Removed paragraphs (7)
Previous report
The Part B off-drug follow-up period through Week 52 remains ongoing. We plan to report additional details from the Week 36 results as well as initial findings from Week 52 at a future medical meeting. Additionally, enrollment of eligible patients into the OLE remains ongoing. We expect to report completed OLE results in the second half of 2027.
Previous report
Other Income
Previous report
Other Income (Expense), Net
Previous report
Other income was $0.3 million for the three months ended June 30, 2026, compared to other expense of $0.3 million for the three months ended June 30, 2025. The change of $0.6 million was primarily related to a loss recorded in the prior year for the change in fair value of the CVR liability.
Previous report
Comparison of the six months ended June 30, 2026 and 2025
Previous report
Loss on Extinguishment of Debt
Reworded paragraphs (32)
Previous wording
Unless otherwise indicated or the context otherwise requires, references in this “Management’s Discussion and Analysis of Financial Condition and Results of Operations” section to “Legacy Q32” refers to the business and operations of Q32 Bio Operations Inc. (previously Q32 Bio Inc.) and its consolidated subsidiaries prior to the Merger, and references to “the Company,” “we,” “us,” “our” and other similar terms refer to the business and operations of Q32 Bio Inc. (previously Homology Medicines, Inc., or Homology) and its consolidated subsidiary following the Merger.
Current wording
Unless otherwise indicated or the context otherwise requires, references in this “Management’s Discussion and Analysis of Financial Condition and Results of Operations” section to “Legacy Q32” refers to the business and operations of Q32 Bio Operations Inc. (previously Q32 Bio Inc.) and its consolidated subsidiaries prior to the Merger, and references to “the Company,” “we,” “us,” “our” and other similar terms refer to the business and operations of Q32 Bio Inc. (previously Homology Medicines, Inc., “Homology”) and its consolidated subsidiary following the Merger.
Previous wording
We announced completion of enrollment in the SIGNAL-AA Part B clinical trial in October 2025. In May 2026, we announced that the first patient had been dosed in the OLE portion of Part B.
Current wording
We announced completion of enrollment in the SIGNAL-AA Part B clinical trial in October 2025. In May 2026, we announced that the first patient had been dosed in the OLE portion of Part B. Dosing of eligible patients into the OLE remains ongoing. We expect to report OLE results in the second half of 2027.
Previous wording
In July 2026, we announced 36-week topline results from the SIGNAL-AA Part B trial. The prespecified primary efficacy analysis was evaluated on the basis of mean percentage change from baseline in SALT scores in the modified intent-to-treat (“mITT”) population at Week 36. Additional prespecified 36-week efficacy analyses included the proportion of patients achieving various relative and absolute SALT improvements including SALT-20 (80% of scalp hair coverage), SALT30 (30% improvement in SALT score from baseline), and SALT50 (50% improvement in SALT score from baseline) responses at Week 36, with off-drug follow-up through Week 52.
Current wording
In July 2026, we announced 36-week topline results from the SIGNAL-AA Part B trial. The prespecified primary efficacy analysis was evaluated on the basis of mean percentage change from baseline in SALT scores in the modified intent-to-treat (“mITT”) population at Week 36. Additional prespecified 36-week efficacy analyses included the proportion of patients achieving various relative and absolute SALT improvements including SALT-20 (80% of scalp hair coverage), SALT 30 (30% improvement in SALT score from baseline), and SALT 50 (50% improvement in SALT score from baseline) responses at Week 36, with off-drug follow-up through Week 52.
Previous wording
40.0% (10/25) of patients in the mITT analysis and 30.3% (10/33) of patients in the intent-to-treat (“ITT”) analysis of all enrolled patients achieved a SALT20 response. Achievement of a SALT20 response was observed in patients with both severe and very severe disease.
Current wording
40.0% (10/25) of patients in the mITT analysis and 30.3% (10/33) of patients in the intent-to-treat (“ITT”) analysis of all enrolled patients achieved a SALT-20 response. Achievement of a SALT-20 response was observed in patients with both severe and very severe disease.
Previous wording
44.0% (11/25) of patients in the mITT analysis and 33.3% (11/33) of patients in the ITT analysis achieved SALT30 response.
Current wording
44.0% (11/25) of patients in the mITT analysis and 33.3% (11/33) of patients in the ITT analysis achieved SALT 30 response.
Previous wording
44.0% (11/25) of patients in the mITT and 33.3% (11/33) of patients in the ITT analysis achieved SALT50 response.
Current wording
44.0% (11/25) of patients in the mITT and 33.3% (11/33) of patients in the ITT analysis achieved SALT 50 response.
Previous wording
We intend to advance bempikibart into a registration-directed program in the first half of 2027 following planned regulatory discussions later this year.
Current wording
We intend to advance bempikibart into a registration-directed program in the first half of 2027 following planned regulatory discussions in the fourth quarter of 2026.
Previous wording
In addition to bempikibart, we are also advancing ADX-914-XL, which is a half-life extended fully human anti-IL-7Rα antibody designed to re-regulate adaptive immune function by blocking IL-7 and TSLP signaling. Developed using half-life extension technology, ADX-914-XL is designed to provide the clinical activity and safety profile observed to date with bempikibart while offering an extended dosing schedule. ADX-914-XL is advancing in pre-clinical development.
Current wording
In addition to bempikibart, we are also advancing ADX-914-XL, a half-life extended fully human anti-IL-7Rα antibody designed to re-regulate adaptive immune function by blocking IL-7 and TSLP signaling. Developed using half-life extension technology, ADX-914-XL is designed to provide the clinical activity and safety profile observed to date with bempikibart while offering an extended dosing schedule. ADX-914-XL is in preclinical development.
Previous wording
ADX-097, a Phase 2 asset from our proprietary tissue-targeted complement inhibitor platform, is a humanized anti-C3d monoclonal antibody (“mAb”) fusion protein that completed Phase 1 clinical trials. In February 2025, we announced a corporate restructuring to focus on the advancement of bempikibart for the treatment of patients with AA. In November 2025, we sold to Akebia Therapeutics, Inc. (“Akebia”) substantially all of our assets related to the research, development, manufacture and commercialization of ADX-097 (the “ADX-097 Asset Sale”). Following the ADX-097 Asset Sale, Akebia is now responsible for any future development and commercialization of ADX-097. As consideration for the ADX-097 Asset Sale, we received an upfront payment of $7.0 million and a payment of $3.0 million on the six-month anniversary of the transaction. We will also receive a near-term milestone payment of $2.0 million upon the earlier of achievement of the first milestone under the Asset Purchase Agreement or December 31, 2026. In addition to these payments, we are eligible to receive up to $580 million upon the achievement of specified milestones, including up to $92.5 million related to development and regulatory milestones and up to $487.5 million related to commercial milestones. We are also eligible to receive tiered royalties on potential future sales of ADX-097 ranging from low single-digit to mid-teen percentages of annual net sales. The royalties will expire on a country-by-country basis on the later to occur of (a) the date of expiration of the last-to-expire valid claim of any transferred patent right that covers such product in such country, and (b) the tenth anniversary of the first commercial sale of such product.
Current wording
ADX-097, a Phase 2 asset from our proprietary tissue-targeted complement inhibitor platform, is a humanized anti-C3d monoclonal antibody (“mAb”) fusion protein that completed Phase 1 clinical trials. In February 2025, we announced a corporate restructuring to focus on the advancement of bempikibart for the treatment of patients with AA. In November 2025, we sold to Akebia Therapeutics, Inc. (“Akebia”) substantially all of our assets related to the research, development, manufacture and commercialization of ADX-097 (the “ADX-097 Asset Sale”). Following the ADX-097 Asset Sale, Akebia is now responsible for any future development and commercialization of ADX-097. As consideration for the ADX-097 Asset Sale, we received an upfront payment of $7.0 million, a payment of $3.0 million on the six-month anniversary of the transaction and a milestone payment of $1.9 million upon the achievement of the first milestone under the Asset Purchase Agreement, which occurred in the third quarter of 2026. In addition to these payments, we are eligible to receive up to $580 million upon the achievement of specified milestones, including up to $92.5 million related to development and regulatory milestones and up to $487.5 million related to commercial milestones. We are also eligible to receive tiered royalties on potential future sales of ADX-097 ranging from low single-digit to mid-teen percentages of annual net sales. The royalties will expire on a country-by-country basis on the later to occur of (a) the date of expiration of the last-to-expire valid claim of any transferred patent right that covers such product in such country, and (b) the tenth anniversary of the first commercial sale of such product.
Previous wording
In addition to ADX-097, we developed a proprietary tissue-targeted complement platform, which is designed to inhibit complement activation in the tissue while minimizing systemic complement blockade, a key differentiator versus current complement therapeutics. Other assets developed from our proprietary platform include ADX-096, a C3d mAb – CR 11-10 fusion protein with preclinical data supportive of its use in ophthalmologic indications as well as potential utility in a broad range of other indications, and C3d mAb fusions and nanobodies designed for tissue-targeted complement inhibition.
Current wording
In addition to ADX-097, we developed a proprietary tissue-targeted complement platform, which is designed to inhibit complement activation in the tissue while minimizing systemic complement blockade, a key differentiator versus current complement therapeutics. Other assets developed from our proprietary platform include ADX-096, a C3d mAb – CR11-10 fusion protein with preclinical data supportive of its use in ophthalmologic indications as well as potential utility in a broad range of other indications, and C3d mAb fusions and convertase targeted nanobodies designed for tissue-targeted complement inhibition.
Previous wording
On July 16, 2026, pursuant to a shelf registration statement on Form S-3 (File No. 333-297027), we completed a public offering (the “Follow-On Financing”) wherein we sold 6,027,399 shares of our common stock, par value $0.0001 per share (the “common stock”), at a public offering price of $18.25 per share and pre-funded warrants to purchase up to 4,931,506 shares of our common stock at a public offering price of $18.2499 per pre-funded warrant. We received net proceeds of $187.6 million from the Follow-On Financing, after deducting underwriting discounts and commissions and offering expenses. In addition, we granted the underwriters a 30-day option to purchase up to an additional 1,643,835 shares of our common stock at the public offering price of $18.25 per share, less underwriting discounts and commissions.
Current wording
On July 16, 2026, pursuant to a shelf registration statement on Form S-3 (File No. 333-297027), we completed a public offering (the “Follow-On Financing”) wherein we sold 6,027,399 shares of our common stock, par value $0.0001 per share (the “common stock”), at a public offering price of $18.25 per share and pre-funded warrants to purchase up to 4,931,506 shares of our common stock at a public offering price of $18.2499 per pre-funded warrant. We received net proceeds of $187.5 million from the Follow-On Financing, after deducting underwriting discounts and commissions and offering expenses.
Previous wording
On June 24, 2026, we paid off the remaining balance in the amount of approximately $6.8 million under our Loan and Security Agreement (the “Loan Agreement”) with Silicon Valley Bank, a division of First-Citizens Bank & Trust Company (“SVB”), pursuant to a Pay-Off Letter between us and SVB dated June 24, 2026. Accordingly, the Loan Agreement has been terminated.
Current wording
On June 24, 2026, we repaid the remaining balance in the amount of approximately $6.8 million under our Loan and Security Agreement (the “Loan Agreement”) with Silicon Valley Bank, a division of First-Citizens Bank & Trust Company (“SVB”), pursuant to a Pay-Off Letter between us and SVB dated June 24, 2026. Accordingly, the Loan Agreement has been terminated.
Previous wording
On March 27, 2026, we entered into a Controlled Equity Offering SM Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co. (the “Sales Agent”), with respect to an at-the-market (“ATM”) offering program pursuant to which we may offer and sell, from time to time at our sole discretion, shares of our common stock through the Sales Agent. The shares offered and sold under the Sales Agreement are offered and sold pursuant to our shelf registration statement on Form S-3 (File No. 333-286491), which was filed with the SEC on April 11, 2025 and declared effective by the SEC on April 21, 2025. We filed a prospectus supplement with the SEC on March 27, 2026, pursuant to which we may offer and sell shares of common stock having an aggregate offering price of up to $14.2 million pursuant to the Sales Agreement. During the six months ended June 30, 2026, we sold 2,326,952 shares of our common stock and received gross proceeds of $14.2 million pursuant to the ATM. On April 24, 2026, we filed an additional prospectus supplement with the SEC, pursuant to which we may offer and sell additional shares having an aggregate offering price of up to $75 million pursuant to the Sales Agreement. As of June 30, 2026, there have been no shares sold under this additional prospectus supplement.
Current wording
On March 27, 2026, we entered into a Controlled Equity Offering SM Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co. (the “Sales Agent”), with respect to an at-the-market (“ATM”) offering program pursuant to which we may offer and sell, from time to time at our sole discretion, shares of our common stock through the Sales Agent. The shares offered and sold under the Sales Agreement are offered and sold pursuant to our shelf registration statement on Form S-3 (File No. 333-286491), which was filed with the SEC on April 11, 2025 and declared effective by the SEC on April 21, 2025. We filed a prospectus supplement with the SEC on March 27, 2026, pursuant to which we may offer and sell shares of common stock having an aggregate offering price of up to $14.2 million pursuant to the Sales Agreement. During the nine months ended September 30, 2026, we sold 2,326,952 shares of our common stock and received gross proceeds of $14.2 million pursuant to the ATM. On April 24, 2026, we filed an additional prospectus supplement with the SEC, pursuant to which we may offer and sell additional shares having an aggregate offering price of up to $75 million pursuant to the Sales Agreement. As of September 30, 2026, there have been no shares sold under this additional prospectus supplement.
Previous wording
As of June 30, 2026, we had cash and cash equivalents of $106.3 million. We expect that our cash and cash equivalents as of June 30, 2026, combined with proceeds received from the Follow-On Financing subsequent to June 30, 2026, will be sufficient to enable us to fund our operating expenses and capital expenditure requirements through topline Phase 3 results of bempikibart from our planned registration-directed program. This estimate is based on assumptions that may prove to be wrong, and we could use our capital resources sooner than currently anticipated.
Current wording
As of September 30, 2026, we had cash and cash equivalents of $289.6 million. We expect that our cash and cash equivalents as of September 30, 2026, will be sufficient to enable us to fund our operating expenses and capital expenditure requirements through topline Phase 3 results of bempikibart from our planned registration-directed program. This estimate is based on assumptions that may prove to be wrong, and we could use our capital resources sooner than currently anticipated.
Previous wording
Research and development expenses were $7.5 million for the six months ended June 30, 2026, compared to $12.3 million for the six months ended June 30, 2025. The decrease in direct research and development expenses was primarily due to a decrease of $1.5 million in ADX-097 expenses due to the sale of ADX-097 to Akebia in November 2025, as well as a decrease of $0.9 million in bempikibart development costs.
Current wording
Research and development expenses were $5.1 million for the three months ended September 30, 2026, compared to $3.6 million for the three months ended September 30, 2025. The increase in direct research and development expenses was primarily due to an increase of $1.7 million in spend related to our bempikibart program, driven by increased manufacturing and clinical costs as we advance bempikibart toward a registration-directed trial expected to begin in the first half of 2027, as well as preclinical development costs for ADX-914-XL. These increases were partially offset by a decrease of $0.3 million in ADX-097 expenses due to the sale of ADX-097 to Akebia in November 2025.
Previous wording
The decrease in personnel-related and consulting costs was primarily related to lower headcount as compared to the prior year resulting from the corporate restructuring in February 2025. Personnel-related and consulting costs for the three months ended June 30, 2026 and 2025 included stock-based compensation expense of $0.2 million and $0.3 million, respectively.
Current wording
The increase in personnel-related and consulting costs was primarily related to higher stock-based compensation expense partially offset by lower headcount in the three months ended September 30, 2026 as compared to the three months ended September 30, 2025. Personnel-related and consulting costs for the three months ended September 30, 2026 and 2025 included stock-based compensation expense of $0.6 million and $0.2 million, respectively.
Previous wording
General and administrative expenses were $4.9 million for the three months ended June 30, 2026, compared to $4.0 million for the three months ended June 30, 2025. The increase of $0.9 million was primarily due to higher stock-based compensation expense and other operating expenses in the three months ended June 30, 2026, as compared to the three months ended June 30, 2025.
Current wording
General and administrative expenses were $5.5 million for the three months ended September 30, 2026, compared to $4.0 million for the three months ended September 30, 2025. The increase of $1.5 million was primarily due to higher stock-based compensation expense and other employee-related costs in the three months ended September 30, 2026, as compared to the three months ended September 30, 2025.
Previous wording
The following table summarizes our results of operations for the six months ended June 30, 2026 and 2025:
Current wording
The following table summarizes our results of operations for the nine months ended September 30, 2026 and 2025:
Previous wording
The following table summarizes our research and development expenses for the six months ended June 30, 2026 and 2025:
Current wording
The following table summarizes our research and development expenses for the nine months ended September 30, 2026 and 2025:
Previous wording
Research and development expenses were $4.3 million for the three months ended June 30, 2026, compared to $5.2 million for the three months ended June 30, 2025. The decrease in direct research and development expenses was primarily due to a decrease of $0.9 million in ADX-097 expenses due to the sale of ADX-097 to Akebia in November 2025, partially offset by an increase of $0.6 million in spend related to our bempikibart program due to increased manufacturing costs and nonclinical activities.
Current wording
Research and development expenses were $12.6 million for the nine months ended September 30, 2026, compared to $15.8 million for the nine months ended September 30, 2025. The decrease in direct research and development expenses was primarily due to a decrease of $1.8 million in ADX-097 expenses due to the sale of ADX-097 to Akebia in November 2025, partially offset by an increase of $0.8 million in bempikibart manufacturing and clinical costs as we advance bempikibart toward a registration-directed trial expected to begin in the first half of 2027.
Previous wording
The decrease in personnel-related and consulting costs was primarily related to lower headcount in the six months ended June 30, 2026 as compared to the prior year associated with the Restructuring Plan in February 2025. Personnel-related and consulting costs for the six months ended June 30, 2026 and 2025 included stock-based compensation expense of $0.4 million and $0.5 million, respectively.
Current wording
The decrease in personnel-related and consulting costs was primarily related to lower headcount in the nine months ended September 30, 2026 as compared to the prior year associated with the restructuring plan in February 2025. Personnel-related and consulting costs for the nine months ended September 30, 2026 and 2025 included stock-based compensation expense of $1.0 million and $0.7 million, respectively.
Previous wording
General and administrative expenses were $9.4 million for the six months ended June 30, 2026, compared to $9.1 million for the six months ended June 30, 2025. The increase of $0.3 million was primarily due to higher stock-based compensation expense and other operating expenses in the six months ended June 30, 2026, as compared to the six months ended June 30, 2025, partially offset by lower corporate legal and audit fees.
Current wording
General and administrative expenses were $14.9 million for the nine months ended September 30, 2026, compared to $13.1 million for the nine months ended September 30, 2025. The increase of $1.7 million was primarily due to higher stock-based compensation expense and other employee-related costs in the nine months ended September 30, 2026, as compared to the nine months ended September 30, 2025, partially offset by lower corporate legal and audit fees.
Previous wording
On June 24, 2026, we paid off the remaining balance of our venture debt in the amount of approximately $6.8 million and recognized a loss on extinguishment of debt of $0.1 million in the three months ended June 30, 2026.
Current wording
On June 24, 2026, we repaid the remaining balance of the venture debt in the amount of approximately $6.8 million and recognized a loss on extinguishment of debt of $0.1 million in the nine months ended September 30, 2026.
Previous wording
Other income was $0.4 million for the six months ended June 30, 2026, compared to $0.9 million for the six months ended June 30, 2025. Other income for the six months ended June 30, 2026 included interest income of $1.0 million, partially offset by interest expense related to our venture debt of $0.4 million, whereas other income for the six months ended June 30, 2025 included interest income of $1.3 million as well as a gain recorded for the change in fair value of the CVR liability of $0.4 million, partially offset by interest expense related to our venture debt of $0.6 million. The overall decrease in other income of $0.4 million was primarily related to higher interest income in the prior year due to higher interest rates as well as the gain recorded in the prior year for the change in fair value of the CVR liability.
Current wording
Other income, net was $2.2 million for the nine months ended September 30, 2026, compared to $1.1 million for the nine months ended September 30, 2025. Other income, net for the nine months ended September 30, 2026 included interest income of $2.7 million, partially offset by interest expense related to our venture debt of $0.4 million. Other income, net for the nine months ended September 30, 2025 included interest income of $1.8 million, as well as a gain recorded for the change in fair value of the liability recorded for the contractual contingent value rights (each, a “CVR”) issued by Homology to its stockholders of record immediately prior to the effective time of the Merger of $0.4 million. These amounts are partially offset by interest expense related to our venture debt of $0.9 million. The overall increase in other income, net of $1.1 million was primarily related to higher interest income in the current year due to higher average cash balances as well as lower interest expense related to our venture debt that was repaid in June 2026.
Previous wording
Since inception, we have incurred significant operating losses and negative cash flows from operations. 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. To date, we have funded our operations primarily from proceeds from the sales of our convertible preferred stock and convertible notes, as well as proceeds from our venture debt, the ADX-097 Asset Sale, the Horizon Collaboration Agreement, the Merger with Homology and accompanying Pre-Closing Financing and the issuance of common stock and pre-funded warrants. From inception through June 30, 2026, we raised $136.0 million in aggregate cash proceeds, net of issuance costs, from the sales of our convertible preferred stock and convertible notes. In addition, we received $55.0 million in payments under the Horizon Collaboration Agreement, $12.5 million in proceeds from our venture debt, $61.3 million, net of issuance costs, in connection with the Merger with Homology, $42.0 million pursuant to the Pre-Closing Financing, $10.0 million pursuant to the ADX-097 Asset Sale, $10.4 million, net of issuance costs, from the issuance of common stock and pre-funded warrants in a Registered Direct Offering, $13.5 million, net of issuance costs, from the issuance of common stock pursuant to the ATM and $53.4 million, net of issuance costs, from the issuance of common stock and pre-funded warrants in the Private Placement. As of June 30, 2026, we had cash and cash equivalents of $106.3 million.
Current wording
Since inception, we have incurred significant operating losses and negative cash flows from operations. 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. To date, we have funded our operations primarily through public and private offerings of our common stock and pre-funded warrants, sales of convertible preferred stock and convertible notes, venture debt, the Merger with Homology and accompanying pre-closing financing and payments under our former collaboration arrangement with Horizon. From inception through September 30, 2026, we raised $264.7 million in aggregate cash proceeds, net of issuance costs, through public and private offerings of our common stock and pre-funded warrants and $136.0 million in aggregate cash proceeds, net of issuance costs, from the sales of our convertible preferred stock and convertible notes. In addition, we received $55.0 million in payments under the Horizon Collaboration Agreement, $12.5 million in proceeds from our venture debt, $61.3 million, net of issuance costs, in connection with the Merger with Homology, $42.0 million pursuant to the pre-closing financing and $11.9 million pursuant to the ADX-097 Asset Sale. We repaid the remaining balance of the venture debt in June 2026. As of September 30, 2026, we had cash and cash equivalents of $289.6 million.
Previous wording
We have incurred significant operating losses since inception and, as of June 30, 2026, had an accumulated deficit of $221.5 million. We expect negative cash flows from operations and net losses for the foreseeable future as we continue to invest significantly in research and development of our product candidates and platform. We have not yet commercialized any product and do not expect to generate revenue from sales of any products for several years, if at all.
Current wording
We have incurred significant operating losses since inception and, as of September 30, 2026, had an accumulated deficit of $230.5 million. We expect negative cash flows from operations and net losses for the foreseeable future as we continue to invest significantly in research and development of our product candidates and platform. We have not yet commercialized any product and do not expect to generate revenue from sales of any products for several years, if at all.
Previous wording
As of June 30, 2026, we had cash and cash equivalents of $106.3 million. We expect that our cash and cash equivalents as of June 30, 2026, combined with proceeds received from the Follow-On Financing subsequent to June 30, 2026, will be sufficient to enable us to fund our operating expenses and capital expenditure requirements through topline Phase 3 results of bempikibart from our planned registration-directed program. Management based its projections of operating capital requirements on our current operating plan, which includes several assumptions that may prove to be incorrect, and we may use all of our available capital resources sooner than management expects. We expect to seek to raise additional capital through private or public equity or debt financings, loans or other capital sources, which could include collaborations, partnerships or other marketing, distribution, licensing or other strategic arrangements with third parties, or from grants, and may be required to seek additional capital sooner than planned. However, there can be no assurances that we will be able to raise additional capital from these sources on favorable terms, or at all.
Current wording
As of September 30, 2026, we had cash and cash equivalents of $289.6 million. We expect that our cash and cash equivalents as of September 30, 2026 will be sufficient to enable us to fund our operating expenses and capital expenditure requirements through topline Phase 3 results of bempikibart from our planned registration-directed program. Management based its projections of operating capital requirements on our current operating plan, which includes several assumptions that may prove to be incorrect, and we may use all of our available capital resources sooner than management expects. We expect to seek to raise additional capital through private or public equity or debt financings, loans or other capital sources, which could include collaborations, partnerships or other marketing, distribution, licensing or other strategic arrangements with third parties, or from grants, and may be required to seek additional capital sooner than planned. However, there can be no assurances that we will be able to raise additional capital from these sources on favorable terms, or at all.
Previous wording
For the six months ended June 30, 2026, net cash used in operating activities was $9.4 million, which was primarily utilized for the funding of our operating expenses of $16.8 million as we incurred expenses associated with research and development activities including clinical trial activities associated with our bempikibart program. Non-cash expenses include stock-based compensation expense of $3.2 million, non-cash lease expenses of $0.3 million and depreciation expense of $0.2 million. The change in net operating assets and liabilities was primarily attributable to a decrease in prepaid expenses and other current assets of $3.4 million and an increase in accounts payable of $0.7 million, partially offset by a decrease in accrued expenses and other current liabilities of $0.4 million and a decrease in the operating lease liability of $0.3 million.
Current wording
For the nine months ended September 30, 2026, net cash used in operating activities was $13.8 million, which was primarily utilized for the funding of our operating expenses of $27.5 million as we incurred expenses associated with research and development activities including clinical trial activities associated with our bempikibart program. Non-cash expenses include stock-based compensation expense of $6.1 million, non-cash lease expenses of $0.5 million and depreciation expense of $0.3 million. The change in net operating assets and liabilities was primarily attributable to a decrease in prepaid expenses and other current assets of $5.2 million driven by the receipt of milestone payments from Akebia and an increase in accounts payable of $0.2 million, partially offset by a decrease in the operating lease liability of $0.5 million and a decrease in accrued expenses and other current liabilities of $0.3 million.
Previous wording
For the six months ended June 30, 2025, net cash used in operating activities was $23.1 million, which was primarily utilized for the funding of our operating expenses of $21.4 million as we incurred expenses associated with research and development activities including clinical trial activities associated with our bempikibart program. Non-cash expenses include stock-based compensation expense of $2.6 million, non-cash lease expenses of $0.3 million and depreciation expense of $0.2 million, partially offset by a gain of $0.4 million recognized on the change in fair value of the CVR liability. The change in net operating assets and liabilities was primarily attributable to a decrease in accrued expenses and other current liabilities of $3.1 million, a decrease in accounts payable of $2.1 million, an increase in other noncurrent assets of $0.5 million and a decrease in our operating lease liability of $0.3 million, partially offset by a decrease in prepaid expenses and other current assets of $0.4 million.
Current wording
For the nine months ended September 30, 2025, net cash used in operating activities was $27.4 million, which was primarily utilized for the funding of our operating expenses of $29.0 million as we incurred expenses associated with research and development activities including clinical trial activities associated with our bempikibart program. Non-cash expenses include stock-based compensation expense of $3.8 million, non-cash lease expenses of $0.5 million and depreciation expense of $0.3 million, partially offset by a gain of $0.4 million recognized on the change in fair value of the CVR liability. The change in net operating assets and liabilities was primarily attributable to a decrease in accrued expenses and other current liabilities of $3.6 million, a decrease in accounts payable of $2.0 million and a decrease in our operating lease liability of $0.5 million, partially offset by a decrease in prepaid expenses and other current assets of $2.1 million.
Previous wording
There was no net cash used in or provided by investing activities for the six months ended June 30, 2026 and 2025.
Current wording
For the nine months ended September 30, 2026, net cash used in investing activities consisted of purchases of property and equipment. There was no net cash used in or provided by investing activities for the nine months ended September 30, 2025.
Previous wording
For the six months ended June 30, 2026, net cash provided by financing activities consisted of $53.4 million of proceeds from the issuance of common stock and pre-funded warrants in the Private Placement, net of issuance costs, $13.5 million of proceeds from issuance of common stock pursuant to ATM, net of discounts and issuance costs, $10.4 million of proceeds from the issuance of common stock and pre-funded warrants in the Registered Direct Offering, slightly offset by $6.7 million for the payoff of the remaining balance on our venture debt and payments of $3.1 million of principal payments made pursuant to our venture debt. For the six months ended June 30, 2025, there was no net cash used in or provided by financing activities.
Current wording
For the nine months ended September 30, 2026, net cash provided by financing activities consisted of $187.5 million of proceeds from the issuance of common stock and pre-funded warrants pursuant to the Follow-On Financing, net of issuance costs, $53.4 million of proceeds from the issuance of common stock and pre-funded warrants in the Private Placement, net of issuance costs, $13.5 million of proceeds from issuance of common stock pursuant to ATM, net of discounts and issuance costs, $10.4 million of proceeds from the issuance of common stock and pre-funded warrants in the Registered Direct Offering, net of issuance costs, slightly offset by $6.7 million for the payoff of the remaining balance on our venture debt and payments of $3.1 million of principal payments made pursuant to our venture debt.
Previous wording
We believe that, based on our current operating plan, our cash and cash equivalents as of June 30, 2026, combined with proceeds received from the Follow-On Financing subsequent to June 30, 2026, will be sufficient to enable us to fund our operating expenses and capital expenditure requirements through topline Phase 3 results of bempikibart from our planned registration-directed program. Management based its projections of operating capital requirements on our current operating plan, which includes several assumptions that may prove to be incorrect, and we may use all of our available capital resources sooner than we expect.
Current wording
We believe that, based on our current operating plan, our cash and cash equivalents as of September 30, 2026 will be sufficient to enable us to fund our operating expenses and capital expenditure requirements through topline Phase 3 results of bempikibart from our planned registration-directed program. Management based its projections of operating capital requirements on our current operating plan, which includes several assumptions that may prove to be incorrect, and we may use all of our available capital resources sooner than we expect.
Rearranged current paragraphs (2)
Current report — wording carried from elsewhere
We observed changes in biomarkers consistent with the IL-7Rα mechanism and activity mediated by both the TSLP and IL-7 receptors. In SIGNAL-AA Part B, we continued to observe meaningful decreases in key Th2 biomarkers of TARC, IgE, and eosinophils, each suggestive of potent TSLP inhibition. In addition, we observed a decrease in absolute lymphocyte and CD3+ T cell numbers, as well as a reduction in IFNg, IL-17, IL-6 and TNFa serum levels, suggestive of potent IL-7 inhibition. There was no observed increase in infection risk resulting from these lymphocyte changes.
Current report — wording carried from elsewhere
For the nine months ended September 30, 2025, net cash used in financing activities consisted of principal payments made pursuant to our venture debt.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
On June 24, 2026, we paid off the remaining balance of our venture debt in the amount of approximately $6.8 million and recognized a loss on extinguishment of debt of $0.1 million in the six months ended June 30, 2026.