SEC 8-K filings with transcript text
Aug 5, 2026
2 d166048dex991.htm
Exhibit 99.1
ImageneBio Reports Second Quarter 2026 Financial Results
SAN DIEGO, Aug. 5, 2026 (GLOBE NEWSWIRE) — ImageneBio, Inc. (Nasdaq: IMA) (“Imagene” or the “Company”) today reported financial results for the quarter ended June 30, 2026, and provided a company update.
Company Highlights
•
Olevaprubart, also known as IMG-007, the potential first-in-class therapeutic targeting the OX40 pathway, is a non-T cell-depleting, ADCC-silenced, anti-OX40 receptor antagonist with an extended half-life.
•
The Phase 2b ADAPTIVE trial of olevaprubart in moderate-to-severe atopic dermatitis continues to progress as planned under the amended protocol.
•
A long-term extension (LTE) study has been opened for patients enrolled in ADAPTIVE and sites are actively
enrolling patients into the extension protocol.
•
A Phase 2 clinical trial of olevaprubart in alopecia areata is planned to initiate in 2026.
•
The company will present two posters on olevaprubart at the 2026 European Academy of Dermatology and Venereology (EADV) Congress.
•
Imagene strengthened its leadership team with the appointments of Yanina Grant-Huerta as Chief Financial Officer
and Matt Robbins as General Counsel.
•
$136.2 million in cash, cash equivalents and marketable securities as of June 30, 2026, providing anticipated funding for planned operations into the first quarter of 2028.
“Imagene’s olevaprubart is now primed to emerge as the leading OX40 signal blockade program. With our continued progress in advanced clinical development, our conviction remains strong,” said Kristin Yarema, Ph.D., chief executive officer of Imagene. “Olevaprubart was engineered to be a genuinely differentiated medicine with the potential for strong, competitive efficacy and a favorable safety profile. This is what our Phase 2b ADAPTIVE study is designed to evaluate and we are very pleased with our progress. Atopic dermatitis and alopecia areata remain areas of significant unmet need, and, as we are following every new development in the field closely, none of it changes what we believe: that direct, T cell-targeted yet non-T cell depleting approaches like ours have the potential to provide durable, safe and strong benefit for patients. Our programs remain on track and we continue to advance as planned, including welcoming patients who have completed a year of treatment into our long-term extension study.”
Recent Corporate Updates
•
In April 2026, Imagene closed a $30 million private placement with participation from both new and current investors.
•
In July 2026, Imagene appointed Yanina Grant-Huerta as Chief Financial Officer.
•
Grant brings 20 years of financial and accounting leadership experience in the biopharma industry.
•
She most recently served as Chief Accounting Officer at Atara Biotherapeutics and previously spent 14 years at Amgen Inc. in progressively senior finance and business analysis roles.
•
Imagene also appointed Matt Robbins as General Counsel, bringing more than 15 years of corporate, securities, and transactional experience advising public and private life sciences companies.
•
Dr. Ben Porter-Brown transitioned to a consulting role at the end of July 2026, continuing to support the
Company as a consulting clinical development expert and strategic advisor.
Olevaprubart Program Updates
•
Atopic Dermatitis: The previously announced protocol amendment to the ADAPTIVE trial has been implemented, and the study continues to progress under the amended protocol.
•
The amended protocol introduces a robust design intended to further evaluate the potential of olevaprubart in moderate-to-severe atopic dermatitis.
•
Topline data from the study is anticipated in the fourth quarter of 2027.
•
A long-term extension study has been opened for those who have completed one year in the ADAPTIVE study
(NCT07734415) and patients are actively moving into the LTE.
•
The Independent Data Monitoring Committee (IDMC) for the ADAPTIVE study recommended the study proceed with no changes to the protocol or monitoring on July 23, 2026.
•
As of July 31, 2026 no cases of Kaposi sarcoma have been observed across the olevaprubart program, including in ongoing studies.
•
Alopecia Areata: Imagene remains on track to initiate a Phase 2 study of olevaprubart in alopecia areata in 2026.
•
Initial data expected in 2028, leveraging the clinical operations and investigator network the Company has developed through its atopic dermatitis program.
•
Upcoming Scientific Presentations: Imagene will present two posters at the 2026 European Academy of Dermatology and Venereology (EADV) Congress:
•
Title: IMG-007, a non-depleting OX40 antagonist: Optimizing Peak Loading Concentration and Exposure Range to Unlock the Full Potential of OX40-OX40L Pathway Targeting in Immune Mediated Diseases
•
Poster Number: P1683
•
Abstract ID: AS-4099
•
Title: IMG-007, a non-depleting OX40 mAb, produces durable shift i
May 7, 2026
2 d151394dex991.htm
Exhibit 99.1
ImageneBio Reports First Quarter 2026 Financial Results and Provides IMG-007 Program Update
SAN DIEGO, May 7, 2026 (GLOBE NEWSWIRE) — ImageneBio, Inc. (Nasdaq: IMA) (“Imagene” or the “Company”) today reported financial results for the quarter ended March 31, 2026, and provided an update for its lead program, IMG-007, a non-T cell-depleting, ADCC-silenced anti-OX40 receptor antagonist with an extended half-life.
Company Highlights
•
In April 2026, the Company completed a private placement for gross proceeds of approximately $30 million led by new investor, Coastlands Capital, with participation from Trails Edge Capital Partners and existing investors Omega Funds and OrbiMed, among others. The financing extends the Company’s cash runway into the first quarter of 2028 and enables advancement of IMG-007 into a Phase 2 clinical trial in alopecia areata.
•
IMG-007 is the leading receptor-targeting,
non-T cell-depleting OX40 antagonist in active clinical development. The Phase 2b ADAPTIVE trial is progressing under the previously announced amended protocol in North America, with topline data anticipated in the fourth quarter of 2027.
•
The Company will present preclinical data on IMG-007 at the 83rd Annual
Society for Investigative Dermatology (SID) Meeting in May 2026 in Chicago, IL. The oral presentation will characterize how IMG-007’s distinctive design, which targets the OX40 receptor for efficacy while not depleting a patient’s T cells for safety, distinguishes it from other agents in the OX40 class.
“The conviction that brought our investors to this round reflects a fundamental belief that we share: OX40 is an important target with the potential to effectively treat heterogeneous and difficult diseases like atopic dermatitis and alopecia areata in a new way that is focused on T cell biology rather than simply blocking downstream cytokines, and that IMG-007 is the right molecule to showcase what the mechanism can deliver,” said Kristin Yarema, PhD, Chief Executive Officer of Imagene. “With our $30 million financing in place and cash runway extending into Q1 2028, we have the resources to drive these programs forward. We believe the disease-modifying potential of OX40 blockade is beginning to be shown in this evolving field, and we further believe that IMG-007 will ultimately demonstrate a powerful ability to bring patients into deep and durable disease control with infrequent dosing.”
IMG-007 Program Updates
Atopic Dermatitis
•
The previously announced protocol amendment to the ADAPTIVE trial has been implemented, and the study is now progressing under the amended protocol in North America.
•
The amendment introduces a robust design intended to fully evaluate the potential of IMG-007 in moderate-to-severe AD, including the time to onset, depth, and durability of response. The updated protocol systematically explores three variables — exposure, loading regimen, and dosing interval — across an approximately 400-patient study with continuous treatment over one year:
•
Exposure: The amended protocol expands to four IMG-007 dosing regimens plus placebo, evaluating two different doses at each of two dosing intervals. The expanded exposure range is designed to test the hypothesis that broader exposures can deliver better efficacy than has been demonstrated to date in the OX40 class. ADAPTIVE will also be the first OX40 program to evaluate continuous exposure of up to one year in a Phase 2b setting, enabling a systematic assessment of the deepening of response that has been attributed to OX40 blockade.
•
Loading regimen: Reflecting the recognized and growing importance of loading in immunologic and inflammatory diseases — and particularly relevant for the OX40 class given its upstream targeting of activated T cells — the amended protocol systematically studies the contribution of a loading dose regimen to the speed, depth, and consistency of clinical effect.
•
Dosing interval: The four dosing regimens evaluate monthly and quarterly dosing intervals, supported by IMG-007’s approximately 5-week half-life. Less frequent dosing is intended to reduce treatment burden for patients managing a chronic disease.
•
The primary endpoint under the amended protocol is percent change from baseline in EASI at 24 weeks. Secondary endpoints include patients reaching EASI-75, EASI-90, and IGA 0/1, along with safety, pharmacokinetics, and additional clinical and patient-reported outcomes.
•
The amended protocol also incorporates additional study refinements, including stratification of biologic- and/or oral JAK inhibitor-experienced versus naive patients, baseline EASI scores, standardized photography, and a refined approach to rescue therapy.
•
The efficacy dataset will be composed of patients initiated under the amended protocol and is designed to enable a registrational Phase 3 program.
•
Patients currently enrolled under the original ADAPTIVE pr
Mar 10, 2026
2 d130344dex991.htm
Exhibit 99.1
ImageneBio Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Company Update
SAN DIEGO, March 10, 2026 — ImageneBio, Inc. (Nasdaq: IMA) (“Imagene” or the “Company”) today reported financial results for the fourth quarter and full year ended December 31, 2025, and provided a company update.
Company Highlights
•
The IMG-007 Phase 2b ADAPTIVE trial in adults with moderate-to-severe atopic dermatitis (AD) is ongoing at North American sites; the study began enrolling in mid-2025 with topline data expected in 2027. A recent blinded safety review showed a favorable emerging tolerability profile consistent with previous IMG-007 patient experience.
•
The Company has submitted a protocol amendment intended to expand the number and exposure range of dosing regimens being evaluated, characterize the role of loading doses, evaluate patient-friendly dosing intervals, and understand the effect of short- and longer-term treatment with IMG-007.
•
The Company welcomed Dr. Ben Porter-Brown, who brings deep inflammation and medical dermatology experience
including leading the development of anti-OX40L investigational therapeutic amlitelimab through the end of Phase 2, as Chief Medical Officer in February 2026.
•
An oral presentation of IMG-007 preclinical data, including
characterization of the non-depleting nature of the antibody, will be shared at the 83rd Annual Society for Investigative Dermatology (SID) Meeting (May 2026; Chicago, IL).
“IMG-007 is now the leading receptor-targeting OX40 antagonist program in clinical development. Our approach is entirely unlike that of ADCC-enhanced anti-OX40 antibodies such as rocatinlimab: published data has shown rocatinlimab treatment causes deep depletion of T cells, while IMG-007 is a non-T cell depleting antibody. This is a fundamental, intentional, and critical difference in our molecule’s design,” commented Kristin Yarema, PhD, Chief Executive Officer of Imagene. “While the clinical profile of IMG-007 remains early, our safety database continues to grow and we have not seen any of the tolerability issues mechanistically linked to T cell depletion — pyrexia, chills, ulcers — nor have we seen any malignancies. This emerging clinical profile adds to the compelling, competitive efficacy we saw in our proof-of-concept studies in atopic dermatitis and alopecia areata. We are confident that ADAPTIVE, our Phase 2b dose-ranging study in AD, is robust and designed to well characterize IMG-007’s efficacy, safety, and convenience for patients.”
IMG-007 Program Updates
IMG-007 is a novel, non-T cell depleting, receptor-targeting, anti-OX40
monoclonal antibody currently being evaluated in the Phase 2b ADAPTIVE trial in adults with moderate-to-severe AD. The study began enrolling in mid-2025 and is enrolling at North American sites.
•
IMG-007 has been well tolerated in all clinical trials conducted to date,
including in the ADAPTIVE trial. In total, over 150 subjects have participated in clinical trials of IMG-007, including several with six months or more continuous exposure.
•
A blinded safety review was conducted in March 2026 to assess the consistency of IMG-007’s emerging tolerability profile
•
A total of two serious adverse events, both deemed unrelated to IMG-007, have been observed to date across all studies of IMG-007, including in the ADAPTIVE Phase 2b trial
•
Consistent with previous reporting, no cases of administration-associated pyrexia or chills, aphthous or gastrointestinal ulcers, serious infections or malignancies have been observed with IMG-007 treatment to date
•
This includes no cases of Kaposi’s sarcoma
•
Moreover, across all IMG-007 studies using the subcutaneous formulation to date, the rate of injection site reactions has been less than 0.10% with all reported events being mild and transitory
•
The ADAPTIVE study is meeting enrollment expectations and, consistent with previous guidance, remains on track for a topline readout in 2027 with continued strong interest from investigators
•
A previously announced protocol amendment to the ADAPTIVE trial was submitted with intent to:
•
Expand the number and exposure range of dosing regimens studied to fully characterize the clinical profile of IMG-007
•
Characterize the role of loading doses in driving the magnitude of efficacy and time to onset of effect
•
Evaluate patient-friendly dosing intervals
•
Understand the role of short- and longer-term treatment
•
Optimize study execution
“It has been inspiring to hear the enthusiasm for IMG-007 from our investigators and other leading dermatologists, as well as their understanding of its unique features that we believe will prove key to establishing a differentiated efficacy, safety, and convenience profile.” said Dr. Ben Porter-Brown, Chief Medical Officer. ‘’We continue to have strong conviction that IMG-007 has the potential to be the most efficacious of this
This page provides ImageneBio Inc. (IMA) earnings call transcripts from SEC 8-K filings along with AI-powered predictions for post-earnings price movements. Our machine learning models analyze historical earnings data, pre-earnings price patterns, volume changes, and volatility to predict 1-day, 5-day, and 20-day returns after each earnings release.
Earnings transcripts are sourced directly from SEC EDGAR filings. Predictions are generated using gradient boosting models trained on IMA's historical earnings reactions. All predicted returns are shown as percentages, and predicted prices are calculated from the closing price at the time of prediction. Past performance does not guarantee future results.