false 0002093101 0002093101 2026-08-13 2026-08-13
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d)
of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 13, 2026
Atrium Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
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| Delaware |
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001-43008 |
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39-4639499 |
| (State or other jurisdiction of incorporation) |
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(Commission File Number) |
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(IRS Employer Identification No.) |
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| 10578 Science Center Drive, Suite 125 |
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| San Diego, California |
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92121 |
| (Address of principal executive offices) |
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(Zip Code) |
Registrant’s telephone number, including area code: (619) 876-0700
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
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| Title of each class
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Trading Symbol(s) |
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Name of each exchange on which registered |
| Common stock, par value $0.001 per share |
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RNA |
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The Nasdaq Global Select Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On August 13, 2026, Atrium Therapeutics, Inc. announced its financial results for the quarter ended June 30, 2026. The full text of the press release issued in connection with the announcement is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Item 2.02 of this Form 8-K, including Exhibit 99.1 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
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| 99.1+ |
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Press Release, dated August 13, 2026 |
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| 104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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ATRIUM THERAPEUTICS, INC. |
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| Date: August 13, 2026 |
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By: |
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/s/ Kathleen Gallagher |
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Name: Kathleen Gallagher Title: Chief Executive Officer |
Exhibit 99.1
Atrium Therapeutics Reports Second Quarter 2026 Financial Results
— IND clearance for ATR 1072 and launch of Corventis Phase 1/2 trial in
PRKAG2 syndrome —
— Achieved second milestone payment under global cardiovascular collaboration
with Bristol Myers Squibb —
SAN
DIEGO, August 13, 2026 / PRNewswire/ – Atrium Therapeutics, Inc. (Nasdaq: RNA) (“Atrium,” “Atrium Therapeutics,” or the “Company”), a biopharmaceutical company advancing precision cardiology
by developing RNA therapeutics targeted to the heart, today reported financial results for the second quarter ended June 30, 2026, and highlighted recent corporate progress including FDA clearance of its Investigational New Drug (IND)
application for ATR 1072 and continued achievements under its collaboration with Bristol Myers Squibb (BMS).
“Our team continues to execute well,
achieving FDA clearance of our IND for ATR 1072 and launching Corventis — Atrium’s first Phase 1/2 trial and the first clinical study to evaluate a potential disease-modifying treatment for people living with PRKAG2 syndrome,” said
Kathleen Gallagher, President and Chief Executive Officer of Atrium Therapeutics. “Atrium’s precision approach to genetic cardiomyopathies is part of a burgeoning frontier in medicine. Our experienced team is well-positioned to continue
advancing and efficiently expanding our pipeline with urgency on behalf of patients and clinicians.”
Recent Highlights
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Received FDA clearance of IND application and Health Canada No Objection Letter for ATR 1072. FDA cleared
Atrium’s IND application for ATR 1072, allowing the Company to proceed with Corventis, a Phase 1/2 open-label, multicenter clinical trial designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of ATR
1072 in participants living with PRKAG2 syndrome. Additionally, the Company has received a No Objection Letter from Health Canada enabling the activation of planned Corventis study sites in Canada. The study will enroll approximately 37 participants
across two parts: Part A, multiple ascending dose cohorts to characterize safety and support dose selection, and Part B, a single-arm expansion cohort at the recommended Phase 2 dose to further evaluate
efficacy trends in cardiac structure and function. ATR 1072 is Atrium’s first precision cardiology program to enter the clinic. |
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Initiated clinical site activities for Corventis. Atrium continues to expect the first participant to be
enrolled by the end of 2026. |
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Earned a second milestone payment from Bristol Myers Squibb. Atrium achieved a second milestone under its
global cardiovascular collaboration with BMS in August, triggering a payment of $15 million which will be accounted for in the third quarter financial statements. |
Anticipated Upcoming Milestones
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Enroll first participant in the Corventis Phase 1/2 trial for ATR 1072 by the end of 2026. |
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Report initial trial data from Corventis demonstrating proof of concept in the second half of 2027.
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File IND application for ATR 1086 in 2027, with IND-enabling studies
initiating in 2026. |
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We are also advancing two undisclosed pipeline programs in rare cardiomyopathy targets and expect to select our
next development candidate in 2027. |
Second Quarter 2026 Financial Results
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Collaboration Revenue: Collaboration revenue was $3.0 million for the second quarter of 2026,
primarily related to R&D services under Atrium’s research collaboration and license agreement with Bristol Myers Squibb. |
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Research and Development (R&D) Expenses: R&D expenses were $15.3 million for the second
quarter of 2026, primarily reflecting clinical trial preparations, IND-enabling activities, and continued development of the Company’s overall research capabilities. |
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General and Administrative (G&A) Expenses: G&A expenses were $10.3 million for the second
quarter of 2026, driven by employee-related expenses, professional fees, and costs to support the Company’s expanded operations. |
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Cash, Cash Equivalents, and Short-term Investments: As of June 30, 2026, Atrium $263.9 million
in cash, cash equivalents and short-term investments. The Company believes its current cash resources, inclusive of the receipt of the second milestone payment from had BMS earned in August, are sufficient to fund planned operations through mid-2028. |
About Atrium Therapeutics
Atrium Therapeutics, Inc. (Nasdaq: RNA) is pioneering targeted delivery of ribonucleic acid (RNA) therapeutics to the heart to transform the standard of care
for people living with cardiomyopathies. With the U.S. Food and Drug Administration’s (FDA) recent clearance of its Investigational New Drug (IND) application for ATR 1072 for PRKAG2 (Protein Kinase
AMP-activated non-catalytic subunit Gamma 2) syndrome, Atrium is advancing its first precision cardiology program into the clinic through the Corventis Phase 1/2
clinical trial. The Company’s proprietary technology - designed at Avidity Biosciences, Inc. - combines the tissue selectivity of monoclonal antibodies (mAbs) and other targeted delivery ligands with the precision of oligonucleotides and is
designed to selectively target the underlying drivers of genetically driven cardiac diseases through targeted, non-viral delivery of small interfering RNA (siRNA). This approach builds upon learnings from
demonstrated delivery to skeletal muscle and applies it for efficient delivery to the heart, with the potential to overcome challenges associated with non-specific tissue delivery. Beyond ATR 1072, the
Company’s pipeline includes ATR 1086 for PLN (phospholamban) cardiomyopathy and two undisclosed research targets in rare cardiomyopathies.
For more
information about our RNA delivery platform, development pipeline and people, please visit https://atriumtherapeutics.com/ and engage with us on LinkedIn.
Availability of Other Information About Atrium Therapeutics
Investors and others should note that Atrium Therapeutics communicates with its investors and the public using its
website https://atriumtherapeutics.com/, including, but not limited to, Atrium Therapeutics’ disclosures, investor presentations and FAQs, Securities and Exchange Commission (“SEC”) filings, press releases,
public conference call transcripts and webcast transcripts, as well as on LinkedIn. The information that Atrium Therapeutics posts on its website or on LinkedIn could be deemed to be material information. As a result, Atrium
Therapeutics encourages investors, the media, and others interested to review the information that it posts there on a regular basis. The contents of Atrium Therapeutics’ website or social media shall not be deemed incorporated
by reference in any filing under the Securities Act of 1933, as amended.
About PRKAG2 Syndrome
PRKAG2 syndrome is a rare, autosomal dominant, early-onset cardiomyopathy caused by mutations in the PRKAG2 gene, which encodes the Gamma 2 regulatory subunit
of AMPK. Mutations enhance AMPK activity leading to abnormal glycogen accumulation in heart, thickened heart muscles, electrical conduction problems, and arrhythmias. Based on current scientific literature estimates, there are at least 1,000 –
2,000 people with PRKAG2 syndrome in the U.S. Current management is limited to symptomatic treatment; no approved therapies exist to address the underlying genetic driver of disease.
About PLN Cardiomyopathy
Phospholamban
(“PLN”) cardiomyopathy is a rare autosomal dominant, progressive cardiac disease caused by mutations in PLN, a key regulator of sarcoplasmic reticulum Ca2+-ATPase 2a (“SERCA2a”) calcium pump. PLN mutations produce protein
aggregates that disrupt endoplasmic reticulum processes and lead to dilated, arrhythmogenic, or hypertrophic cardiomyopathies and a significantly increased risk of heart failure and sudden cardiac death. There are 2,000 – 4,000 people with
pathogenic PLN variants in the United States. No approved therapies target the underlying molecular cause of the disease.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995.
Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,”
“anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding
Atrium Therapeutics’ (“Atrium’s” or “our”) future results of operations and financial condition; the Company’s expected cash runway and the period over which existing cash, cash equivalents and investments
are expected to fund planned operations; research and development plans; anticipated timing, design and conduct of ongoing and planned preclinical studies and clinical trials for product candidates; the expected development, advancement and clinical
evaluation of ATR 1072 for the treatment of PRKAG2 syndrome, including the expected timing of initiation, enrollment, dosing and availability of data from Corventis; the disease-modifying potential of ATR 1072 to treat PRKAG2 syndrome; our
expectations regarding our RNA delivery platform and ability to generate high-quality cardiology development candidates, the timing and likelihood of regulatory filings and approvals for product candidates; the potential safety and therapeutic
benefits of our product candidates; the timing and likelihood of success; plans and objectives of management for future operations; and future results of anticipated product development efforts. You should not place undue reliance on these
statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Particular areas where risks or uncertainties could
cause Atrium’s actual results to be materially different than those expressed in Atrium’s forward-looking statements include but are not limited to: the initiation, timing, progress, potential registrational quality, and results of our
research and development programs, preclinical studies, any clinical trials, and other regulatory submissions; the potential for clinical trial results to differ from our preclinical studies; our ability to timely enroll a sufficient number of
patients in our clinical trials, such as Corventis; the beneficial characteristics, including potential safety, efficacy and therapeutic effects of our product candidates and the potential advantages of our
product candidates compared to alternative therapies; the success and capabilities of the RNA delivery platform; the prevalence of certain diseases and conditions we intend to treat and our
estimates of the potential market opportunity for our product candidates; the timing of and costs involved in obtaining and maintaining regulatory approval of our current and any future product candidates; our ability to develop our current and
future product candidates; the implementation of our strategic plans for our business, product candidates, research programs and technologies; developments related to our competitors and our industry; our competitive position and the success of
competing therapies that are or may become available; our ability to maintain our current license agreements and collaborations and identify and enter into future license agreements and collaborations; the expected potential benefits of strategic
collaborations with third parties and our ability to attract collaborators in the future; our reliance on third parties for manufacturing and to conduct preclinical studies and clinical trials of our product candidates; our ability to efficiently
and cost-effectively conduct our current and future trials; the costs of operating as a public company; the accuracy of our estimates regarding future expenses, future revenue, capital requirements and the need for additional financing; the period
over which we estimate our existing cash and cash equivalents will be sufficient to fund our future operating expenses and capital expenditure requirements; and other factors specified under the heading “Risk Factors” in Atrium’s
Quarterly Report on Form 10-Q for the quarter ended June 30, 2026 filed with the SEC and in other filings and furnishings made by Atrium with the SEC from time to time, which are all available on the
SEC’s website at www.sec.gov. Atrium is providing the information in this communication as of this date and does not undertake any obligation to update any forward-looking statements contained in this communication as a result of new
information, future events or otherwise, except as required by law.
Investor Relations and Media Contact:
Stephanie Kenney
Chief Corporate Affairs Officer
investors@atrium-tx.com
Atrium Therapeutics, Inc.
Condensed Statements of Operations and Comprehensive Loss
(in thousands except per share information)
(Unaudited)
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2026 |
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2025 |
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2026 |
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2025 |
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| Collaboration revenue |
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$ |
3,004 |
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$ |
3,847 |
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$ |
22,639 |
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$ |
5,420 |
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| Operating expenses: |
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| Research and development |
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15,343 |
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13,293 |
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32,000 |
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20,230 |
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| General and administrative |
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10,279 |
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3,418 |
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30,537 |
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5,506 |
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| Total operating expenses |
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25,622 |
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16,711 |
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62,537 |
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25,736 |
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| Loss from operations |
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(22,618 |
) |
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(12,864 |
) |
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(39,898 |
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(20,316 |
) |
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| Other income (expense) |
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| Interest income |
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2,104 |
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— |
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2,757 |
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— |
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| Other income (expense), net |
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328 |
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(15 |
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322 |
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(12 |
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| Total other income (expense) |
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2,432 |
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(15 |
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3,079 |
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(12 |
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| Net loss |
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$ |
(20,186 |
) |
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$ |
(12,879 |
) |
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$ |
(36,819 |
) |
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$ |
(20,328 |
) |
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| Basic and diluted net loss per common share |
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$ |
(1.18) |
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$ |
(0.75 |
) |
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$ |
(2.15 |
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$ |
(1.19 |
) |
| Weighted average common shares outstanding used in the calculation of basic and diluted net loss
per common share |
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17,106 |
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17,106 |
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17,106 |
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17,106 |
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| Other comprehensive loss: |
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| Net unrealized loss on short-term investments |
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(235 |
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— |
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(235 |
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— |
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| Comprehensive loss |
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$ |
(20,421 |
) |
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$ |
(12,879 |
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$ |
(37,054 |
) |
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$ |
(20,328 |
) |
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Atrium Therapeutics, Inc.
Condensed Balance Sheets
(in thousands, except par value)
(Unaudited)
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June 30, 2026 |
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December 31, 2025 |
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| Assets |
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| Current assets: |
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| Cash and cash equivalents |
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$ |
72,334 |
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$ |
— |
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| Short-term investments |
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191,566 |
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— |
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| Prepaid assets |
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4,506 |
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1,535 |
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| Restricted cash, current portion |
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311 |
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— |
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| Other current assets |
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6,334 |
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1,310 |
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| Total current assets |
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275,051 |
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2,845 |
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| Restricted cash, net of current portion |
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106 |
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— |
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| Property and equipment, net |
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4,066 |
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2,724 |
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| Right-of-use
asset |
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1,289 |
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2,784 |
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| Total assets |
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$ |
280,512 |
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$ |
8,353 |
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| Liabilities and Stockholders’ Equity / Former Parent’s Deficit |
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| Current liabilities: |
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| Accounts payable |
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$ |
3,513 |
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$ |
4,398 |
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| Accrued liabilities |
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13,312 |
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|
8,945 |
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| Accrued compensation |
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3,962 |
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3,147 |
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| Lease liabilities |
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1,683 |
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3,672 |
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| Deferred revenue, current portion |
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9,038 |
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21,639 |
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| Total current liabilities |
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31,508 |
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41,801 |
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| Deferred revenue, net of current portion |
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33,653 |
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28,691 |
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| Other long-term liabilities |
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|
775 |
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|
574 |
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| Total liabilities |
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65,936 |
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|
71,066 |
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| Commitments and contingencies |
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| Stockholders’ equity / Former Parent’s deficit: |
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| Preferred stock, $0.001 par value: 40,000 shares authorized; no shares issued and
outstanding |
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— |
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— |
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| Common stock, $0.001 par value: 400,000 shares authorized; 17,106 shares issued and outstanding as
of June 30, 2026, and no shares authorized, issued, or outstanding as of December 31, 2025 |
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16 |
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— |
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| Additional paid-in capital |
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222,853 |
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— |
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| Accumulated deficit |
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(8,058 |
) |
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— |
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| Accumulated other comprehensive loss, net |
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(235 |
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— |
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| Net investment from Former Parent |
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— |
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(62,713 |
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| Total stockholders’ equity/Former Parent’s deficit |
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214,576 |
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(62,713 |
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| Total liabilities and Stockholders’ equity/Former Parent’s deficit |
|
$ |
280,512 |
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$ |
8,353 |
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