Apogee Therapeutics, Inc.
For the period ended Jun 30, 2026. Filed Aug 10, 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.
Jun 30, 2026 · Filed Aug 10, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-03-31; filed 2026-05-11.
0001193125-26-215698
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-06-30; filed 2026-08-10.
0001193125-26-341289
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 88 previous paragraphs and 120 current paragraphs.
66 unchanged; 18 reworded; 36 added; 3 removed; 1 previous and 0 current paragraphs rearranged.
Tables are not compared: 0 previous and 1 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 (36)
Current report
Zumilokibart – anti-IL13 antibody
Current report
In May 2026, we announced positive 16-week induction dose optimization results from the Part B portion of the APEX Phase 2 clinical trial of zumilokibart in patients with moderate-to-severe AD. The Part B portion of the trial enrolled 346 adult patients who were randomized 1:1:1:1 to receive high-, mid- or low-dose zumilokibart or placebo. The primary endpoint for the Part B portion of the trial was the proportion of patients who achieved at least a 75% reduction in EASI-75 at Week 16. Secondary endpoints included vIGA 0/1, EASI-90, Itch NRS, EASI-100 and very low disease activity (“vLDA”), defined as EASI-90 plus I-NRS 0/1, at Week 16. The Part B trial met its primary endpoint, with all three zumilokibart dose arms demonstrating statistically significant improvements in EASI-75 compared to placebo at Week 16. EASI-75 was achieved by 61.6% of patients in the high-dose arm, 65.9% of patients in the mid-dose arm and 50.5% of patients in the low-dose arm, compared to 23.4% of patients in the placebo arm. The planned Phase 3 dose, corresponding to the mid-dose arm, also met key secondary endpoints at Week 16, with 46.0% of patients achieving vIGA 0/1 compared to 10.9% in the placebo arm, 47.4% of patients achieving EASI-90 compared to 9.3% in the placebo arm, 50.5% of patients achieving an I-NRS ≥4 reduction from baseline compared to 13.9% in the placebo arm, 16.5% of patients achieving EASI-100 compared to 3.4% in the placebo arm and 20.6% of patients achieving vLDA compared to 4.5% in the placebo arm. Zumilokibart was well tolerated in Part B, with a safety profile generally consistent with other agents in the class. The most common TEAEs in patients treated with zumilokibart were nasopharyngitis, headache and noninfective conjunctivitis. For the planned Phase 3 dose, corresponding to the mid-dose arm, the pooled conjunctivitis rate, including all conjunctivitis preferred terms, was 10.6%, compared to 15.1% for the low-dose arm and 20.7% for the high-dose arm. Based on results from the APEX clinical program, we plan to initiate Phase 3 trials of zumilokibart for moderate-to-severe AD with the mid-dose in the second half of 2026.
Current report
Anticipated Program Milestones for Zumilokibart for the Treatment of AD
Current report
Based on results from the APEX clinical program, we plan to initiate Phase 3 trials of zumilokibart for moderate-to-severe AD (the “ADventure trials”) with the mid-dose in the second half of 2026. The ADventure 1 and ADventure 2 trials are randomized, placebo-controlled, replicate Phase 3 monotherapy trials evaluating zumilokibart in patients with moderate-to-severe AD (EASI ≥16, vIGA ≥3, BSA ≥10%). Each study is expected to enroll approximately 400 patients and includes a 16-week induction period followed by maintenance through Week 52. In maintenance, patients will receive dosing every three or six months. The co-primary endpoint is EASI-75 and IGA 0/1 at Week 16, with additional assessment at Week 52. We anticipate the ADventure 1 and ADventure 2 monotherapy data readouts in the first half of 2028.
Current report
The ADventure TCS Phase 3 trial will evaluate zumilokibart in combination with background topical corticosteroids (“TCS”) in patients with moderate-to-severe AD (EASI ≥16, vIGA ≥3, BSA ≥10%). The randomized, placebo-controlled study is expected to enroll approximately 400 patients and includes a 16-week induction period and maintenance through Week 52. The co-primary endpoint is EASI-75 and IGA 0/1 at Week 16, with longer-term outcomes assessed at Week 52. We anticipate the ADventure TCS combination data readout in the second half of 2028.
Current report
Apogee also expects Phase 2 APEX Part B 52-week maintenance data in the first half of 2027, Phase 2 APEX Part A 2-year follow-up data in the second half of 2027 and the potential launch of zumilokibart for the treatment of AD in 2029, pending regulatory interactions.
Current report
APG531
Current report
In June 2026, we also announced that we entered into an antibody discovery agreement with Paragon (the “2026 Option Agreement”) pursuant to which Paragon agrees to generate and characterize monospecific antibody candidates directed to interleukin 31 receptor (IL-31R). Contemporaneously with the execution of the 2026 Option Agreement, we entered into a license agreement with Paragon (the “IL-31R License Agreement”) pursuant to which Paragon granted to us an exclusive, worldwide, royalty-bearing, sublicensable right and license with respect to certain information, patent rights and sequence information related to antibodies discovered under the 2026 Option Agreement and directed at the IL-31R target to use, make, sell, import, export and otherwise exploit the antibodies directed at the IL-31R target. For additional information on the 2026 Option Agreement and IL-31R License Agreement, see the section titled “Notes to Consolidated Financial Statements—Other Significant Agreements” included elsewhere in this Report.
Current report
We anticipate announcing plans for the APG531 program in the first half of 2027.
Current report
Merger Agreement
Current report
On June 18, 2026, we entered into the Merger Agreement with Parent, Merger Sub and, solely for the limited purposes set forth therein, AbbVie. Under the terms of the Merger Agreement and in accordance with the General Corporation Law of the State of Delaware (“DGCL”), if the Merger is completed, Merger Sub will merge with and into us, and we will continue as the surviving corporation as a wholly owned subsidiary of Parent. In addition, all shares of our common stock outstanding immediately prior to closing (other than Cancelled Shares and Dissenting Shares (as defined in the Merger Agreement)) will be cancelled and converted into the right to receive $135.11 per share in cash, without interest and subject to any applicable withholding taxes.
Current report
The completion of the pending Merger is conditioned upon (i) the adoption of the Merger Agreement and approval of the Merger by the holders of at least a majority of the outstanding shares of our voting common stock, (ii) for so long as at least 6,061,821 shares of our non-voting common stock remain issued and outstanding, the adoption of the Merger Agreement and approval of the Merger by at least a majority of the outstanding shares of our non-voting common stock, (iii) the expiration or earlier termination of any waiting period (and any extension thereof) under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (the “HSR Act”), and the filings specified on the Company Disclosure Schedule to the Merger Agreement (which will also include filings to be made to the U.K. Competition and Markets Authority under the U.K. Enterprise Act of 2002 or the European Commission under Article 22 of the EU Merger Regulation, in each case, if such authority indicates in writing to AbbVie that it has decided to formally investigate the Merger or has received a referral request, as applicable) and any voluntary commitment or agreement with the U.S. Federal Trade Commission (“FTC”), U.S. Department of Justice (“DOJ”) or any other governmental body not to consummate the Merger, (iv) the absence of legal restraints preventing or otherwise making illegal the consummation of the Merger, (v) the accuracy of representations and warranties that we made and compliance by us with covenants contained in the Merger Agreement, subject to qualifications, (vi) there not having been a “Material Adverse Effect” (as defined in the Merger Agreement) with respect to us since the date of the Merger Agreement that is continuing, and (vii) other customary conditions.
Current report
As previously disclosed in the definitive proxy statement filed on July 13, 2026 (the “Proxy Statement”), we and Parent each filed a notification of the proposed Merger with the FTC and DOJ under the HSR Act on July 6, 2026. On August 5, 2026, the applicable waiting period under the HSR Act expired. The expiration of the waiting period under the HSR Act satisfies one of the conditions to the completion of the Merger.
Current report
Also as previously disclosed in the Proxy Statement, on July 7, 2026, Parent filed a notification under the German Act against Restraints of Competition 1957, as amended, with the German Federal Cartel Office (the “FCO”). As disclosed in the definitive additional materials filed on August 3, 2026, which amended and supplemented the Proxy Statement (the “Proxy Supplement”), Parent obtained from the FCO unconditional clearance for the Merger in Germany. In addition, as previously disclosed in the Proxy Statement, on July 7, 2026, Parent filed a notification under the Austrian Cartel Act 2005, as amended, with the Austrian Federal Competition Authority, for which the Phase 1 statutory review period expired on August 4, 2026. Accordingly, the closing conditions relating to the receipt of Regulatory Approvals with respect to the German Act against Restraints of Competition 1957, as amended, and the Austrian Cartel Act 2005, as amended, have been satisfied.
Current report
As previously disclosed in the Proxy Supplement, on July 27, 2026, Parent also filed a notification under the Australian Competition and Consumer Act 2010, as amended, with the Australian Competition and Consumer Commission (the “ACCC”), for which the Phase 1 statutory review period will expire on September 7, 2026, unless such period is terminated earlier by the ACCC. Completion of the Merger remains subject to the satisfaction or waiver of other customary closing conditions described in the Merger Agreement, including the receipt of any clearance, consent or affirmative approval applicable to the filings specified on the Company Disclosure Schedule to the Merger Agreement.
Current report
The parties expect the Merger to close in the third quarter of 2026. Following completion of the Merger, our common stock will no longer be publicly listed.
Current report
The Merger Agreement contains termination rights for us and Parent. If the Merger Agreement is terminated under specified circumstances, we will be required to pay Parent a fee of $381,273,716.
Current report
Revenue Participation Right Financing
Current report
On May 26, 2026, we entered into a revenue participation right purchase and sale agreement (the “Revenue Share Agreement”) with Annapurna Aggregator L.P., an affiliate of funds managed by Blackstone Life Sciences (“BXLS”). Pursuant to the Revenue Share Agreement, in exchange for an upfront payment of $100.0 million (the “Tranche 1 Funding”), BXLS purchased from us the right to receive tiered revenue share payments (the “Revenue Share Payments”) with respect to annual worldwide net product sales (“Net Sales”) of zumilokibart. In addition, under the Revenue Share Agreement:
Current report
i.
Current report
BXLS will purchase additional Revenue Share Payments from us in exchange for a payment of $100.0 million (the “Tranche 2 Funding”), upon the occurrence of full enrollment of patients in both of our planned registrational monotherapy Phase 3 clinical trials of zumilokibart in patients with AD, coded by us as APG777-301 and APG777-302 (the “Zumilokibart Phase 3 Clinical Trials”);
Current report
ii.
Current report
BXLS will purchase additional Revenue Share Payments from us in exchange for a payment of $200.0 million (the “Tranche 3 Funding”), upon the occurrence of positive data readouts from the Zumilokibart Phase 3 Clinical Trials meeting the success criteria set forth in the Revenue Share Agreement; and
Current report
iii.
Current report
BXLS will purchase additional Revenue Share Payments from us in exchange for a payment (the “Tranche 4 Funding”) of, at our election, between $250.0 million and up to $400.0 million (“Tranche 4 Maximum Purchase Price”), upon zumilokibart’s receipt of marketing approval from the U.S. Food and Drug Administration for the treatment of AD on or prior to December 31, 2030 (the “Tranche 4 Trigger”).
Current report
The Revenue Share Payments are based on tiered percentage rates of aggregate annual Net Sales of zumilokibart (“Annual Aggregate Product Net Sales”). Under the Revenue Share Agreement, the revenue percentage payable to BXLS is the sum of (a) the base revenue percentage (the “Base Revenue Percentage”) and (b) the tranche 4 revenue percentage (the “Tranche 4 Revenue Percentage” and, together with the Base Revenue Percentage, the “Revenue Percentages”), which applies only from and after the Tranche 4 Funding.
Current report
The table below summarizes the Revenue Percentages payable to BXLS, based on the tiers of Annual Aggregate Product Net Sales. The Base Revenue Percentage shown reflects the rate applicable after receipt of the Tranche 1 Funding; this rate would double upon receipt of the Tranche 2 Funding, and double again upon receipt of the Tranche 3 Funding. The Tranche 4 Revenue Percentage is subject to proportional adjustment if the Tranche 4 Funding is less than the Tranche 4 Maximum Purchase Price:
Current report
The Tranche 4 Revenue Percentage is subject to a cap of $1.0 billion in aggregate Tranche 4-related Revenue Share Payments to BXLS, after which the Tranche 4 Revenue Percentage for Tier 1 decreases to 0.00%.
Current report
The Revenue Share Payments will be payable during a term commencing on the date of the first commercial sale of zumilokibart and ending on the fifteenth (15th) anniversary of the date of receipt of marketing approval for zumilokibart.
Current report
If the Company consummates a change of control with a third party, the Company will be required to pay a certain specified amount to BXLS and would also receive credits against future Revenue Share Payments otherwise payable to BXLS following the consummation of the change of control.
Current report
In the alternative, at any time following execution of a definitive agreement for a change of control, we (or the surviving entity) may elect, in lieu of the required payment described above, to pay BXLS a specified amount calculated under the Revenue Share Agreement to buy down a portion of future Revenue Share Payments (each, a "Buy-Back Option"). If we exercise a Buy-Back Option, the Revenue Percentage will be adjusted downward in accordance with the Revenue Share Agreement, and if the Buy-Back Option is exercised prior to the Tranche 4 Trigger, BXLS will no longer be obligated to pay the Tranche 4 Funding, and in such case the Tranche 4 Revenue Percentages across all tiers will be 0.00%. Under the Revenue Share Agreement, for the purposes of providing additional assurance to BXLS, including in the event of a recharacterization, we have granted BXLS a backup security interest in, among other things, the revenue participation right, the Revenue Share Payments, and our intellectual property and other product rights related to zumilokibart. This backup security interest will terminate upon the later of (a) a change of control with a permitted transferee and (b) BXLS’s receipt of the applicable change of control payment. We and BXLS also agree to negotiate in good faith a debt financing of up to $500.0 million upon mutual agreement. The Revenue Share Agreement contains customary representations, warranties and indemnities of us and BXLS, and customary covenants on our part.
Current report
General and Administrative Expenses
Current report
Merger Transaction
Current report
Merger transaction expenses represent costs incurred in connection with the Merger Agreement discussed above. These costs primarily consist of legal and SEC-related fees.
Current report
Interest Expense
Current report
Interest expense consists of interest accrued on our revenue share liability, which arises from our Revenue Share Agreement with BXLS.
Removed paragraphs (3)
Previous report
Zumilokibart (APG777) – anti-IL13 antibody
Previous report
In February 2025, we announced that we had commenced dosing of the Part B portion of the APEX Phase 2 trial. Part B is testing low, medium (Part A dose), and high dose regimens against placebo. In January 2026, we announced that we completed Part B enrollment ahead of schedule and exceeded target enrollment with a total of 347 patients. We expect to report 16-week topline induction data from Part B in the second quarter of 2026. Subject to positive results and regulatory alignment with the U.S. Food and Drug Administration (the “FDA”), we plan to initiate Phase 3 trials in AD in the second half of 2026, enabling a potential launch of zumilokibart for the treatment of AD in 2029.
Previous report
General and Administrative
Reworded paragraphs (18)
Previous wording
You should read the following discussion of our financial condition and results of operations in conjunction with the condensed consolidated financial statements and related notes included elsewhere in this Quarterly Report, as well as our audited consolidated financial statements and the related notes included in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”). The following discussion contains forward-looking statements that reflect our current plans, forecasts, estimates and beliefs and involve risks and uncertainties. Our historical results are not necessarily indicative of the results that may be expected for any period in the future. Our actual results, outcomes and the timing of events could differ materially from those discussed in the forward-looking statements. Factors that could cause or contribute to these differences include those discussed below and elsewhere in this Quarterly Report, particularly in the section titled “Special Note Regarding Forward Looking Statements” and “Risk Factors.” We urge you to consider these factors carefully in evaluating the forward-looking statements contained in this Quarterly Report. Forward-looking statements are not historical facts, reflect our current views with respect to future events, and apply only as of the date made. We do not intend, and undertake no obligation, to update these forward-looking statements, except as required by law. Unless the context requires otherwise, references to “we,” “us,” “our,” “Apogee” or “the Company” refer to Apogee Therapeutics, Inc. and its subsidiaries.
Current wording
You should read the following discussion of our financial condition and results of operations in conjunction with the condensed consolidated financial statements and related notes included elsewhere in this Quarterly Report, as well as our audited consolidated financial statements and the related notes included in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”). The following discussion contains forward-looking statements regarding the proposed Merger, including the timing, completion and anticipated benefits of the Merger and the satisfaction of the conditions to closing, and forward looking statements that reflect our current plans, forecasts, estimates and beliefs and involve risks and uncertainties. Our historical results are not necessarily indicative of the results that may be expected for any period in the future. Our actual results, outcomes and the timing of events could differ materially from those discussed in the forward-looking statements. Factors that could cause or contribute to these differences include those discussed below and elsewhere in this Quarterly Report, particularly in the section titled “Special Note Regarding Forward Looking Statements” and “Risk Factors.” We urge you to consider these factors carefully in evaluating the forward-looking statements contained in this Quarterly Report. Forward-looking statements are not historical facts, reflect our current views with respect to future events, and apply only as of the date made. We do not intend, and undertake no obligation, to update these forward-looking statements, except as required by law. Unless the context requires otherwise, references to “we,” “us,” “our,” “Apogee” or “the Company” refer to Apogee Therapeutics, Inc. and its subsidiaries.
Previous wording
Our pipeline comprises multiple antibody programs being developed initially for the treatment of I&I indications as monotherapies and combinations, including zumilokibart (APG777), APG279 (zumilokibart + APG990), APG273 (zumilokibart + APG333), and APG808 (each a “program” or “product candidate”). With four validated targets in our portfolio, we are seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of our novel antibodies. Based on a broad pipeline and depth of expertise, we believe we can deliver value and meaningful benefit to patients underserved by today’s standard of care. We believe each of our product candidates has potential for broad application across multiple I&I indications.
Current wording
Our pipeline comprises multiple antibody programs being developed initially for the treatment of I&I indications as monotherapies and combinations, including zumilokibart (APG777), APG279 (zumilokibart + APG990), APG273 (zumilokibart + APG333), APG531 and APG808 (each a “program” or “product candidate”). With five validated targets in our portfolio, we are seeking to achieve best-in-class efficacy and dosing through monotherapies and combinations of our novel antibodies. Based on a broad pipeline and depth of expertise, we believe we can deliver value and meaningful benefit to patients underserved by today’s standard of care. We believe each of our product candidates has potential for broad application across multiple I&I indications.
Previous wording
The APEX Part A induction regimen was designed to exceed EBGLYSS exposures by approximately 30% to 40% with potential for improved clinical outcomes and a maintenance regimen designed to equal lebrikizumab’s exposures. The results at Week 16 of the Part A study showed that patients in the highest zumilokibart exposure quartile (n=19) achieved the highest clinical response of any quartile in a post hoc exposure-response analysis. These patients had a mean 84.0% reduction in EASI from baseline, 89.5% of patients reaching EASI-75, 63.2% achieving IGA0/1, and 63.2% achieving EASI-90, demonstrating a robust response at the highest exposure level. The highest zumilokibart Part B dose was designed to exceed EBGLYSS exposures by approximately 90 to 100% which is similar to the exposure obtained in the highest quartile of the Part A results.
Current wording
The APEX Part A induction regimen was designed to exceed EBGLYSS exposures by approximately 30% to 40% with potential for improved clinical outcomes and a maintenance regimen designed to equal lebrikizumab’s exposures. The results at Week 16 of the Part A study showed that patients in the highest zumilokibart exposure quartile (n=19) achieved the highest clinical response of any quartile in a post hoc exposure-response analysis. These patients had a mean 84.0% reduction in EASI from baseline, 89.5% of patients reaching EASI-75, 63.2% achieving vIGA0/1, and 63.2% achieving EASI-90, demonstrating a robust response at the highest exposure level. The highest zumilokibart Part B dose was designed to exceed EBGLYSS exposures by approximately 90 to 100% which is similar to the exposure obtained in the highest quartile of the Part A results.
Previous wording
In April 2025, we initiated a Phase 1b trial of zumilokibart (APG777) in patients with mild-to-moderate asthma, and in January 2026, we announced positive interim data from the trial. The trial is a double-blind, placebo-controlled trial evaluating the safety and tolerability of zumilokibart in patients with mild-to-moderate asthma. The trial is designed to also evaluate fractional exhaled nitric oxide (“FeNO”) suppression, a biomarker of Type 2 inflammation that has shown the strongest correlation with exacerbations in asthma. The trial enrolled 31 adult patients who were randomized 3:1 to zumilokibart versus placebo and participants received a single dose of 720 mg of zumilokibart or placebo on day 1. Nineteen of the patients with mild-to-moderate asthma had a FeNO baseline ≥25 ppb, representative of asthma with Type 2 inflammation, and as a result met the pre-specified criteria for the analysis population.
Current wording
In April 2025, we initiated a Phase 1b trial of zumilokibart in patients with mild-to-moderate asthma, and in January 2026, we announced positive interim data from the trial. The trial is a double-blind, placebo-controlled trial evaluating the safety and tolerability of zumilokibart in patients with mild-to-moderate asthma. The trial is designed to also evaluate fractional exhaled nitric oxide (“FeNO”) suppression, a biomarker of Type 2 inflammation that has shown the strongest correlation with exacerbations in asthma. The trial enrolled 31 adult patients who were randomized 3:1 to zumilokibart versus placebo and participants received a single dose of 720mg of zumilokibart or placebo on day 1. Nineteen of the patients with mild-to-moderate asthma had a FeNO baseline ≥25 ppb, representative of asthma with Type 2 inflammation, and as a result met the pre-specified criteria for the analysis population.
Previous wording
Zumilokibart demonstrated robust and durable suppression of FeNO following a single dose in the analysis population. A maximum absolute mean FeNO reduction of 45 ppb (60% decrease from baseline) after a single dose was observed in the analysis population. Durable FeNO suppression through 16 weeks was observed for all patients in the analysis population. Zumilokibart also demonstrated suppression of FeNO through 32 weeks for those patients in the analysis population with follow up available at the time of the data cut (n=3), supporting the potential for three- or six- month dosing. In the trial, positive trends were observed in forced expiratory volume in one second (“FEV1”) and across Type 2 biomarkers for all available data in the analysis population. FEV1 is a PD measure of lung function. Based on these results, we anticipate sharing our plans in the second half of 2026 to further evaluate zumilokibart in the ASPIRE Phase 2 asthma trial.
Current wording
Zumilokibart demonstrated robust and durable suppression of FeNO following a single dose in the analysis population. A maximum absolute mean FeNO reduction of 45 ppb (60% decrease from baseline) after a single dose was observed in the analysis population. Durable FeNO suppression through 16 weeks was observed for all patients in the analysis population. Zumilokibart also demonstrated suppression of FeNO through 32 weeks for those patients in the analysis population with follow up available at the time of the data cut (n=3), supporting the potential for three- or six- month dosing. In the trial, positive trends were observed in forced expiratory volume in one second (“FEV1”) and across Type 2 biomarkers for all available data in the analysis population. FEV1 is a PD measure of lung function. Based on these results, we anticipate initiating the ASPIRE Phase 2b asthma trial in the first half of 2027.
Previous wording
We expect that results from the Phase 1b trial of zumilokibart for the treatment of asthma, in addition to topline induction data from the Part B portion of the APEX Phase 2 trial in AD, will allow us to determine dose selections for further expansion indications in 2027 and beyond, including but not limited to asthma and EoE. We expect to announce plans for the Phase 2 ASPIRE trial for the treatment of asthma and the Phase 2 ELEVATE trial for the treatment of EoE in the second half of 2026. Based on our clinical data, we expect to further evaluate additional opportunities to develop zumilokibart for other I&I indications, including alopecia areata, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria, and prurigo nodularis.
Current wording
We expect that results from the Phase 1b trial of zumilokibart for the treatment of asthma, in addition to topline induction data from the Part B portion of the APEX Phase 2 trial in AD, will allow us to determine dose selections for further expansion indications in 2027 and beyond, including but not limited to asthma and EoE. We expect to announce plans for the Phase 2 ELEVATE trial for the treatment of EoE in the second half of 2026. Based on our clinical data, we expect to further evaluate additional opportunities to develop zumilokibart for other I&I indications, including alopecia areata, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria, and prurigo nodularis.
Previous wording
APG279 – Combination of zumilokibart (APG777) and APG990 – anti-OX40L antibody
Current wording
APG279 – Combination of zumilokibart and APG990 – anti-OX40L antibody
Previous wording
SQ APG990 evaluated in the study included 75mg, 150mg, 300mg, 600mg and 1,200mg. In March 2025, we announced positive interim safety and PK data from the trial. PK data showed a half-life of approximately 60 days across doses tested. APG990, in single doses up to 1,200mg, was well-tolerated and showed a favorable safety profile, consistent with other assets targeting OX40L. The most common (≥10%) TEAEs were headache. 53% of participants observed at least one TEAE and there were no Grade 3 TEAEs related to study drug or severe adverse events. No adverse events led to study discontinuation. There were no cases of pyrexia or chills.
Current wording
In August 2024, we initiated a Phase 1 clinical trial of APG990, which was designed as a double-blind, placebo-controlled, first-in-human, SAD trial designed to evaluate the safety and PK of APG990 in 40 healthy adult participants across five cohorts. Doses of SQ APG990 evaluated in the study included 75mg, 150mg, 300mg, 600mg and 1,200mg. In March 2025, we announced positive interim safety and PK data from the trial. PK data showed a half-life of approximately 60 days across doses tested. APG990, in single doses up to 1,200mg, was well-tolerated and showed a favorable safety profile, consistent with other assets targeting OX40L. The most common (≥10%) TEAEs were headache. 53% of participants observed at least one TEAE and there were no Grade 3 TEAEs related to study drug or severe adverse events. No adverse events led to study discontinuation. There were no cases of pyrexia or chills.
Previous wording
In July 2025, we commenced dosing in the Phase 1b trial of APG279 against DUPIXENT in patients with moderate-to-severe AD. Enrollment was completed with 86 patients, and we expect a data readout in the second half of 2026. The initial clinical trial of APG279 is being conducted as a coadministration of zumilokibart and APG990. We plan to advance the development of APG279 in future studies as a coformulation. The PK data for APG990, when considered together with APG279 coformulation data, provides the potential for dosing the combination two to four times per year with a single 2 mL coformulated injection.
Current wording
In July 2025, we commenced dosing in the Phase 1b trial of APG279 against DUPIXENT in patients with moderate-to-severe AD. Enrollment was completed with 86 patients, and we expect a data readout in the second half of 2026. The initial clinical trial of APG279 is being conducted as a coadministration of zumilokibart and APG990. We plan to advance the development of APG279 in future studies as a coformulation. The PK data for APG990, when considered together with APG279 coformulation data, provides the potential for dosing the combination two to four times per year with a single 2 mL coformulated injection. We anticipate the Phase 1b trial of APG279 against DUPIXENT to readout in the second half of 2026.
Previous wording
APG273 – Combination of zumilokibart (APG777) and APG333 - anti-TSLP antibody
Current wording
APG273 – Combination of zumilokibart and APG333 - anti-TSLP antibody
Previous wording
APG333, with single doses of up to 1,000 mg, was well-tolerated across the four cohorts. The most common TEAEs occurring in ≥10% of APG333 treated participants were headache and upper respiratory tract infection. TEAEs were generally mild and self-limited and there were no dose dependent trends in TEAEs seen. There were no Grade 3 TEAEs or severe adverse events; and no adverse events led to study discontinuation.
Current wording
APG333, with single doses of up to 1,000mg, was well-tolerated across the four cohorts. The most common TEAEs occurring in ≥10% of APG333 treated participants were headache and upper respiratory tract infection. TEAEs were generally mild and self-limited and there were no dose dependent trends in TEAEs seen. There were no Grade 3 TEAEs or severe adverse events; and no adverse events led to study discontinuation.
Previous wording
We plan to announce additional clinical plans for APG273 in 2026 to support advancement into future combination trials in asthma and COPD.
Current wording
We plan to announce additional clinical plans for APG273 in the second half of 2026 to support advancement into future combination trials in asthma and COPD.
Previous wording
The following summarizes key business developments for the three months ended March 31, 2026, excluding program updates discussed in the “Overview” section above.
Current wording
The following summarizes key business developments for the six months ended June 30, 2026, excluding program updates discussed in the “Overview” section above.
Previous wording
During the three months ended March 31, 2026, we sold 369,220 shares of common stock under our at the market offering program (“ATM Facility”) for gross proceeds of $29.7 million, less commissions and other offering expenses of $0.8 million.
Current wording
During the six months ended June 30, 2026, we sold 369,220 shares of common stock under our at the market offering program (“ATM Facility”) for gross proceeds of $29.7 million, less commissions and other offering expenses of $0.8 million, which sales took place during the three months ended March 31, 2026. No shares were sold under the ATM Facility during the three months ended June 30, 2026.
Previous wording
We have incurred significant operating losses since inception. Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of any programs we may develop. We generated a net loss of $74.1 million for the three months ended March 31, 2026. As of March 31, 2026, we had an accumulated deficit of $635.9 million. We expect to continue to incur significantly increased expenses for the foreseeable future if and as we continue to operate our business.
Current wording
We have incurred significant operating losses since inception. Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of any programs we may develop. We generated a net loss of $160.0 million for the six months ended June 30, 2026. As of June 30, 2026, we had an accumulated deficit of $721.7 million. We expect to continue to incur significantly increased expenses for the foreseeable future if and as we continue to operate our business.
Previous wording
Any changes in the outcome of any of these variables with respect to the development of programs that we may identify could mean a significant change in the costs and timing associated with the development of such programs. For example, if the U.S. Food and Drug Administration (“FDA”) or another regulatory authority were to require us to conduct clinical trials beyond those that we currently anticipate will be required for the completion of clinical development of a program, or if we experience significant delays in our clinical trials due to patient enrollment, macroeconomic events or other reasons, we would be required to expend significant additional financial resources and time on the completion of clinical development. We may never obtain regulatory approval for any of our programs.
Current wording
Any changes in the outcome of any of these variables with respect to the development of programs that we may identify could mean a significant change in the costs and timing associated with the development of such programs. For example, if the FDA or another regulatory authority were to require us to conduct clinical trials beyond those that we currently anticipate will be required for the completion of clinical development of a program, or if we experience significant delays in our clinical trials due to patient enrollment, macroeconomic events or other reasons, we would be required to expend significant additional financial resources and time on the completion of clinical development. We may never obtain regulatory approval for any of our programs.
Previous wording
Our provision for state income taxes was $0.1 million and $0.1 million for the three months ended March 31, 2026 and 2025, respectively.
Current wording
Our provision for state income taxes was $0.1 million and $0.2 million for the three and six months ended June 30, 2026, respectively. Our provision for state income taxes was $0.1 million and $0.2 million for the three and six months ended June 30, 2025, respectively.
Previous wording
A discussion regarding our financial condition and results of operations for the three months ended March 31, 2026 compared to the three months ended March 31, 2025 is presented below.
Current wording
A discussion regarding our financial condition and results of operations for the three and six months ended June 30, 2026 compared to the three and six months ended June 30, 2025 is presented below.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
In August 2024, we initiated a Phase 1 clinical trial of APG990, which was designed as a double-blind, placebo-controlled, first-in-human, SAD trial designed to evaluate the safety and PK of APG990 in 40 healthy adult participants across five cohorts. Doses of