Full Press Release Details
ImageneBio Reports Third Quarter 2025 Financial Results and Provides
IMG-007 Program Update Following Closing of Reverse Merger, Concurrent Financing, and Strengthening of Management Team
$142.6 million cash and cash equivalents and marketable securities as of September 30, 2025
Protocol amendment for ongoing Phase 2b ADAPTIVE study of IMG-007 in atopic dermatitis (AD)
announced to optimize study design in alignment with IMG-007's unique molecular attributes; strong patient enrollment continues
Novel alopecia areata data including biomarkers from Phase 1b/2a study to be presented at upcoming Inflammatory Skin Disease Summit (ISDS)
Strengthened leadership team and board with addition of Dr. Kristin Yarema as Chief Executive Officer, Dr. Kurinji
Pandiyan as Chief Strategy and Operations Officer, Dr. Renuka Sivendran as Chief Technical Officer, and Joe Slattery as an independent director
SAN DIEGO, November 12, 2025, - ImageneBio, Inc. (Nasdaq: IMA, "Imagene," or the "Company"), a clinical-stage biotechnology
company developing therapeutics for patients with immunological, autoimmune and inflammatory diseases, including IMG-007, an anti-OX40 monoclonal antibody with multiple differentiating features, today
announced financial results for the quarter ended September 30, 2025, and provided an update on its program.
"We are in a wonderful position
as we complete our first quarter as a public company. Atopic dermatitis is a chronic, serious and highly prevalent inflammatory disease where new treatments are much needed. Despite the impressive multibillion dollar market size, today only around
15% of eligible patients receive advanced therapy including biologics, and more than a third of those patients do not receive sufficient relief from that treatment. We have spent our first few months as a new team engaging with our networks of top
key opinion leaders, treating physicians, and other experts in atopic dermatitis, as well as gaining valuable insights from the recent, extensive OX40-targeting data shared by our peers," commented Kristin Yarema, Ph.D., Chief Executive
She continued, "Our recent learnings reinforce our belief that the anti-OX40/OX40L class, with its unique mechanism, is on a promising
path towards adoption in atopic dermatitis and other inflammatory and autoimmune indications. However, the peer data to date also highlight the need for a differentiated anti-OX40 treatment that is safe and can be administered at optimal doses for
maximum efficacy. Both thoughtful study design and high-quality execution are essential to achieve success-we must sweat the small stuff.' We believe IMG-007 is the only anti-OX40 in mid- to late-stage clinical development that is non-T cell depleting and receptor-targeting, with a roughly 5-week half-life. This
combination of mechanistic and pharmacologic properties has the potential to offer a best-in-class profile for patients. As we continue to advance our ongoing Phase 2b
trial, we intend to use our learnings to amend the study in ways that we believe will help us best demonstrate the differentiated potential of IMG-007."
IMG-007 Program Updates
Ongoing Phase 2b Clinical Trial and Upcoming Protocol Amendment
The Phase 2b ADAPTIVE trial is a randomized, placebo-controlled dose-finding study designed to evaluate the efficacy and safety of various dose regimens of IMG-007 in adults with moderate-to-severe AD, recruiting both biologic- and/or JAK inhibitor-experienced and naive
Upcoming Data Presentations
Imagene will have two
posters and an oral presentation at the upcoming 6th Annual Inflammatory Skin Disease Summit (ISDS) in New York November 12-15, 2025.
"The data we are presenting from both trials at ISDS adds to the complete picture of how IMG-007 is distinctive and exciting. Our AA data represent the first clinical results for an anti-OX40/OX40L agent in patients with severe alopecia areata, a disease for which there are few treatment options and no
targeted biologics approved. The biopsy biomarker data provides a richer understanding of the potential role OX40 inhibition can play in reducing inflammation in the scalps of AA patients," Dr. Yarema commented. "The promising early
data IMG-007 has shown in AA patients illustrates this program's potential as a pipeline in a product.'"
Kristin Yarema, Ph.D, joined as Chief Executive Officer as previously announced in July 2025, taking on the role as the merger was completed and Imagene was
established as a public company.
Kurinji Pandiyan, Ph.D., joined as
Chief Strategy and Operations Officer in September 2025
Renuka Sivendran, Ph.D., joined the Company in September 2025 as Chief Technical Officer to lead
manufacturing and all other CMC related activities
Joe Slattery was recently appointed to the Board of Directors as an independent director and will serve as Chair of the Audit Committee.
Joe is a former public company CFO and a deeply experienced biotechnology industry board member.
Third Quarter 2025 Financial Results
As of September 30, 2025, the Company had cash, cash equivalents, and marketable securities of $142.6 million as compared to $12.1 million as of December 31, 2024. The increase is primarily the result of the completion of the
merger between Inmagene Biopharmaceutics with Ikena Oncology, Inc. (Ikena). Additionally, concurrently with the closing of the merger, the Company completed a $75.0 million private placement with a syndicate of existing Ikena investors and new
Research and Development (R&D) Expenses: R&D expenses for the three months ended September 30, 2025 was $15.6 million
as compared to $3.9 million for the three months ended September 30, 2024. The increase of $11.7 million is primarily due increased clinical trial expenses and recognition of non-cash
stock-based compensation expense upon completion of the merger.
General and administrative (G&A) Expenses:
General and administrative expenses for the three months ended September 30, 2025 were $11.0 million compared to $1.7 million for the three
months ended September 30, 2024. The increase of $9.3 million was primarily due to a $5.2 million increase in stock-based compensation and increases in professional services and compensation costs.
Net Loss: Net loss for the three months ended September 30, 2025 was $24.8 million as
compared to $3.2 million for the same period in 2024. The increase of $21.6 million was due to additional operating costs in connection with the merger and associated transaction costs.
About ImageneBio, Inc.
ImageneBio is a clinical-stage
biotechnology company dedicated to developing therapeutics for patients with immunological, autoimmune, and inflammatory diseases with differentiated clinical profiles. The company's program, IMG-007, is
a receptor targeting, nondepleting anti-OX40 monoclonal antibody with multiple differentiating features. Imagene has completed Phase 1b/2a clinical trials of IMG-007 in both atopic dermatitis and alopecia
areata and is currently conducting a Phase 2b clinical trial of IMG-007 in patients with moderate-to-severe atopic dermatitis.
For more information, please visit www.imagenebio.com.
Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities
Litigation Reform Act of 1995, including, without limitation, statements regarding: the ongoing Phase 2b ADAPTIVE study, including ImageneBio's plans to submit a protocol amendment thereto and the design thereof; the potential benefits of
the protocol amendment; belief that the anti-OX40/OX40L class is on a promising path towards adoption in AD and other inflammatory and autoimmune indications; the potential benefits of OX40/OX40L antagonists generally and IMG-007 specifically in AD and atopic dermatitis, including its best-in-class potential and as a pipeline in a product, including
potential in AA; and other statements regarding management's intentions, plans, beliefs, expectations or forecasts for the future. Words such as "will," "can," "expect," "may,"
"plan," "potential," "goal," or other words that convey uncertainty of future events or outcomes are used to identify these forward-looking statements. These statements are subject to a number of risks,
uncertainties and assumptions, including, but not limited to: risks associated with the nonclinical and clinical development and regulatory approval of IMG-007, including potential delays in the completion of
clinical trials and potential safety and other complications thereof; the timing of the availability of data from the Company's clinical trials; the clinical utility, potential differentiation and/or benefits and market acceptance of IMG-007; the requirement for additional capital to continue to advance the IMG-007 program, which may not be available on favorable terms or at all; the Company's
ability to attract, hire, and retain skilled executive officers and employees; the Company's ability to protect its intellectual property and proprietary technologies; the Company's reliance on third parties, contract manufacturers, and
contract research organizations; the possibility that the Company may be adversely affected by other economic, political, business, or competitive factors; and risks associated with changes in applicable laws or regulations or government resources
and policies. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. These and other risks and uncertainties are more fully described in
the Company's filings with the Securities and Exchange Commission (the SEC), including the factors described in the section titled "Risk Factors" in the Company's Registration Statement on Form
S-1, filed with the SEC on September 8, 2025, and in the Company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, being filed
with the SEC later today. You should not place undue reliance on these forward-looking statements, which are made only as of the date hereof. The Company undertakes no obligation to update such statements to reflect events that occur or
circumstances that exist after the date on which they were made, except as required by law.
Investor and Media Contact:
Financial Statements
Condensed Consolidated Statements of Operations
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| (Unaudited) | (Unaudited) | (Unaudited) | (Unaudited) | |||||||||||||
| License revenue | $ | - | $ | 3,500 | $ | 800 | $ | 3,500 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 15,558 | 3,885 | 25,251 | 28,350 | ||||||||||||
| General and administrative | 11,036 | 1,651 | 15,496 | 6,008 | ||||||||||||
| Total operating expenses | 26,594 | 5,536 | 40,747 | 34,358 | ||||||||||||
| Loss from operations | (26,594 | ) | (2,036 | ) | (39,947 | ) | (30,858 | ) | ||||||||
| Other income (expense), net | 1,741 | (1,147 | ) | 1,432 | (898 | ) | ||||||||||
| Loss before income taxes | $ | (24,853 | ) | $ | (3,183 | ) | $ | (38,515 | ) | $ | (31,756 | ) | ||||
| Income tax benefit | (74 | ) | - | (74 | ) | - | ||||||||||
| Net loss | $ | (24,779 | ) | $ | (3,183 | ) | $ | (38,441 | ) | $ | (31,756 | ) | ||||
| Accretion of redeemable convertible preferred shares | (846 | ) | (2,998 | ) | (7,046 | ) | (8,757 | ) | ||||||||
| Net loss attributable to common stockholders | $ | (25,625 | ) | $ | (6,181 | ) | $ | (45,487 | ) | $ | (40,513 | ) | ||||
| Other comprehensive loss: | ||||||||||||||||
| Unrealized gain on marketable securities | 94 | - | 94 | - | ||||||||||||
| Foreign currency translation adjustment | (3 | ) | 2 | (29 | ) | (98 | ) | |||||||||
| Total comprehensive loss | $ | (24,688 | ) | $ | (3,181 | ) | $ | (38,376 | ) | $ | (31,854 | ) | ||||
| Net loss attributable to common stockholders | ||||||||||||||||
| Loss per share - basic and diluted: | ||||||||||||||||
| Common Stock | $ | (2.91 | ) | $ | (2.58 | ) | $ | (9.98 | ) | $ | (19.14 | ) | ||||
| Series A convertible preferred shares | $ | (2.91 | ) | $ | (2.58 | ) | $ | (9.98 | ) | $ | (19.14 | ) | ||||
| Weighted average shares outstanding, basic and diluted: | ||||||||||||||||
| Common Stock | 8,526,781 | 1,400,557 | 3,808,867 | 1,121,742 | ||||||||||||
| Series A convertible preferred shares | 270,345 | 994,869 | 750,707 | 994,869 |
Condensed Consolidated Balance Sheets
| September 30, 2025 | December 31, 2024 | |||||||
| Assets | ||||||||
| Cash and cash equivalents | $ | 103,162 | $ | 12,118 | ||||
| Marketable Securities | 39,421 | - | ||||||
| Prepaids and other current assets | 4,949 | 350 | ||||||
| Total current assets | 147,532 | 12,468 | ||||||
| Operating lease right-of-use assets, net | 884 | 547 | ||||||
| Promissory note receivable from related party | 7,510 | - | ||||||
| Other non-current assets | 4,952 | 1,019 | ||||||
| Deferred offering costs | - | 1,888 | ||||||
| Total assets | $ | 160,878 | $ | 15,922 | ||||
| Liabilities and stockholders' equity | ||||||||
| Total current liabilities | $ | 11,144 | $ | 17,209 | ||||
| Long term liabilities | 9,902 | 239 | ||||||
| Total liabilities | 21,046 | 17,448 | ||||||
| Redeemable convertible preferred shares | - | 159,039 | ||||||
| Stockholders' equity | 139,832 | (160,565 | ) | |||||
| Total liabilities and stockholders' equity | $ | 160,878 | $ | 15,922 |